Patent Application
20250143856
The present invention relates to an implantable apparatus for obtaining urinary control and emptying of the urinary bladder, thereby preventing or treating involuntary urinary retention. More particularly, the invention relates to an implantable apparatus for discharging urine from the urinary bladder with a powered member operating from the outside of the urinary bladder assisted by a support structure.
Urinary dysfunction is commonly caused by spinal cord injuries which involve involuntary urinary retention. This condition is associated with urinary infections, renal damages, or damages to the urinary tract. A common treatment of urinary retention is continuous or intermittent catherization. Besides the inconvenience for the patient, catheters always represent a risk of acquiring infections.
According to an aspect, an implantable pumping device for evacuating urine from the urinary bladder of a patient is provided. The implantable pumping device comprises a first constriction device configured to constrict a portion of the urinary bladder for closing a first portion of the urinary bladder. The implantable pumping device further comprises a second constriction device configured to constrict a second portion of the urinary bladder, downstream the first portion, for evacuating urine from the urinary bladder when the first portion of the urinary bladder is closed. The implantable pumping device further comprises a controller configured to control the first and second constriction device.
According to an aspect, an implantable pumping device for evacuating urine from the urinary bladder (U) of a patient is provided. The implantable pumping device comprises a rotor carrying a constriction device. The constriction device comprises a first constriction element, a second constriction element and a third constriction element. The constriction elements are position equidistantly from an axis of rotation of the rotor. The implantable pumping device further comprises a support element spaced from the rotor. The implantable pumping device is applied on the urinary bladder so that the urinary bladder extends between the support element and the rotor. The implantable pumping device further comprises a controller configured to control the rotor so that the constriction elements successively constrict a series of selected portions of the urinary bladder in order to evacuate urine from the urinary bladder.
According to an aspect, an implantable pumping device for evacuating urine from the urinary bladder of a patient is provided. The implantable pumping device comprises a first operably hydraulic constriction element configured to be inflated to constrict the urinary bladder for restricting the flow of fluid therethrough. The implantable pumping device further comprises a second operable hydraulic constriction element configured to be inflated to constrict the urinary bladder for restricting the flow of fluid therethrough and for evacuating urine from the urinary bladder. The implantable pumping device further comprises an interconnecting fluid conduit fluidly connecting the first operable hydraulic constriction element to the second operable hydraulic constriction element. The first operable hydraulic constriction element is configured to be placed at a first portion of the urinary bladder for constricting the first portion of the luminary organ for restricting the flow of fluid therethrough, the second operable hydraulic constriction element is configured to be placed at a second portion of the urinary bladder, downstream the first portion, for constricting the second portion of the urinary bladder for restricting the flow of fluid therethrough and for evacuating urine from the urinary bladder, and the interconnecting fluid conduit is configured to conduct fluid from the first operable hydraulic constriction element to the second operable hydraulic constriction element when the pressure increases in the first operable hydraulic constriction element, such that second operable hydraulic constriction element constricts the second portion of the urinary bladder further.
According to an aspect, an implantable pumping device for evacuating urine from a urinary bladder of a patient is provided. The implantable pumping device comprises a first implantable constriction device for constricting the urinary bladder. The first implantable constriction device comprises a first operable hydraulic constriction element configured to be inflated and thereby expand in a first direction towards the urinary bladder to constrict a first portion of the urinary bladder for restricting the flow of fluid therethrough. The first implantable constriction device further comprises a supporting operable hydraulic constriction element configured to be inflated and thereby expand in the first direction towards the urinary bladder to support the first operable hydraulic constriction element in constricting the first portion of the urinary bladder for restricting the flow of fluid therethrough. The implantable pumping device further comprises a second implantable constriction device similar to the first implantable constriction device. The second implantable constriction device is configured to constrict a second portion of the urinary bladder downstream the first portion in order to evacuate urine from the urinary bladder. The second portion extends a longer distance along an axial direction than the first portion.
According to an aspect, an implantable pumping device for evacuating urine from a urinary bladder of a patient is provided. The implantable pumping device comprises a first constriction device for constricting the urinary bladder. The first constriction device comprises a first operable hydraulic constriction element configured to be inflated to exert a pressure on the urinary bladder in a first direction to constrict a first portion of the urinary bladder for restricting the flow of fluid therethrough. The first constriction device further comprises a second operable hydraulic constriction element configured to be inflated to exert a pressure on the urinary bladder in a second direction to constrict the first portion of the urinary bladder for restricting the flow of fluid therethrough. The first constriction device further comprises a first hydraulic system in fluid connection with the first operable hydraulic constriction element. The first constriction device further comprises a second hydraulic system in fluid connection with the second operable hydraulic constriction element. The first and second operable hydraulic constriction elements are adjustable independently from each other. The implantable pumping device further comprises a second constriction device for constricting the urinary bladder and for evacuating urine from the urinary bladder. The second constriction device comprises a third operable hydraulic constriction element configured to be inflated to exert a pressure on the urinary bladder in a first direction to constrict a second portion of the urinary bladder for restricting the flow of fluid therethrough and for evacuating urine from the urinary bladder. The second constriction device further comprises a fourth operable hydraulic constriction element configured to be inflated to exert a pressure on the urinary bladder in a second direction to constrict the second portion of the urinary bladder for restricting the flow of fluid therethrough and for evacuating urine from the urinary bladder. The second constriction device further comprises a third hydraulic system in fluid connection with the third operable hydraulic constriction element. The second constriction device further comprises a fourth hydraulic system in fluid connection with the fourth operable hydraulic constriction element. The third and fourth operable hydraulic constriction elements are adjustable independently from each other.
According to an aspect, an implantable pumping device for evacuating urine from the urinary bladder of a patient is provided. The implantable pumping device comprises a first constriction device for constricting the urinary bladder. The first constriction device comprises an operable hydraulic constriction element configured to be inflated to exert a pressure on the urinary bladder. The first constriction device further comprises a first hydraulic reservoir for holding a hydraulic fluid. The first constriction device further comprises a first hydraulic pump for pumping fluid from the first hydraulic reservoir to the first operable hydraulic constriction element. The first constriction device further comprises a first fluid conduit creating a fluid connection between the first hydraulic reservoir and the first hydraulic pump. The implantable pumping device further comprises a second constriction device for constricting the urinary bladder downstream the first constriction device for evacuating urine from the urinary bladder. The second constriction device comprises a second operable hydraulic constriction element configured to be inflated to exert a pressure on the urinary bladder. The second constriction device further comprises a second hydraulic reservoir for holding a hydraulic fluid. The second constriction device further comprises a second hydraulic pump for pumping fluid from the second hydraulic reservoir to the second operable hydraulic constriction element. The second constriction device further comprises a second fluid conduit creating a fluid connection between the second hydraulic reservoir and the second hydraulic pump. The implantable pumping device further comprises an electrode arrangement configured to be arranged between at least one of the first constriction device, the second constriction device and the urinary bladder. The electrode arrangement is configured to engage and electrically stimulate muscle tissue of the urinary bladder to exercise the muscle tissue to improve the conditions for long term implantation of the implantable pumping device.
According to an aspect, an implantable pumping device for evacuating urine from the urinary bladder of a patient is provided. The implantable pumping device comprises a first constriction device for constricting the urinary bladder for restricting the flow of fluid therethrough. The first constriction device comprises a first operable hydraulic constriction element configured to be inflated to exert a pressure on the urinary bladder. The first constriction device further comprises a second operable hydraulic constriction element configured to be inflated to exert a pressure on the urinary bladder. The first constriction device further comprises a first hydraulic pump for pumping fluid to the operable hydraulic constriction element. The first constriction device further comprises a second hydraulic pump for pumping fluid to the operable hydraulic constriction element. The first constriction device further comprises a motor. The motor is mechanically connected to the first and second hydraulic pump for propelling the first and second hydraulic pump. The implantable pumping device further comprises a second constriction device for constricting the urinary bladder, downstream the first constriction device. The second constriction device is configured for evacuating urine from the urinary bladder. The second constriction device is similar to the first constriction device.
According to an aspect, an implantable pumping device for evacuating urine from the urinary bladder of a patient is provided. The implantable pumping device comprises a first constriction device for constricting a urinary bladder for restricting the flow of fluid therethrough. The first constriction device comprises a first operable hydraulic constriction element configured to be inflated to exert a pressure on the urinary bladder. The first constriction device further comprises a first hydraulic pump for pumping a hydraulic fluid to the first operable hydraulic constriction element. The implantable pumping device further comprises a second constriction device for constricting a urinary bladder, downstream the first constriction device, for evacuating urine from the urinary bladder. The second constriction device comprises a second operable hydraulic constriction element configured to be inflated to exert a pressure on the urinary bladder. The second constriction device further comprises a second hydraulic pump for pumping a hydraulic fluid to the second operable hydraulic constriction element. The implantable pumping device further comprises an implantable energy storage unit. The implantable pumping device further comprises a capacitor connected to the implantable energy storage unit and connected to at least one of the first and second hydraulic pump. The capacitor is configured to be charged by the implantable energy storage unit and to provide at least one of the first and second hydraulic pump with electrical power.
According to an aspect, an implantable pumping device for evacuating urine from a urinary bladder of a patient is provided. The implantable pumping device comprises a first constriction device for constricting the urinary bladder for restricting the flow of fluid therethrough. The implantable constriction device comprises a first operable hydraulic constriction element configured to be inflated to exert a pressure on the urinary bladder. The first constriction device further comprises a first hydraulic pump for pumping a hydraulic fluid to the first operable hydraulic constriction element. The implantable pumping device comprises a second constriction device configured to constrict the urinary bladder, downstream the first constriction device, for evacuating urine from the urinary bladder. The second constriction device comprises a second operable hydraulic constriction element configured to be inflated to exert a pressure on the urinary bladder. The second constriction device comprises a second hydraulic pump for pumping a hydraulic fluid to the second operable hydraulic constriction element. The implantable pumping device further comprises a controller configured to control the first and second hydraulic pump. The controller comprises a sensor adapted to detect a magnetic field and a processing unit having a sleep mode and an active mode. The implantable pumping device further comprises an external control unit adapted to be arranged outside of the patient's body. The external control unit comprising a first coil adapted to create a magnetic field detectable by the internal sensor. The controller is further configured to, in response to a detected magnetic field exceeding a predetermined value, setting the processing unit in an active mode.
According to an aspect, a method of implanting an implantable pumping device is provided. The method comprises the steps of making an incision in the body of the patient, for accessing the urinary bladder. Dissecting a portion of the urinary bladder. Inserting an implantable pumping device into the body of the patient. Placing the implantable pumping device in connection with the urinary bladder, such that the implantable pumping device can constrict the urinary bladder to restrict the flow of fluid therethrough and to evacuate urine from the urinary bladder.
According to an aspect, a method in an implantable controller, for controlling an implantable pumping device for constricting the urinary bladder and for evacuating urine from the urinary bladder is provided. The method comprises releasing the pressure in a first and a second implantable hydraulic constriction element such that substantially no pressure is exerted on the urinary bladder. The method further comprises measuring the pressure in the first and/or the second implantable hydraulic constriction elements, when substantially no pressure is exerted on the urinary bladder. The method further comprises increasing the pressure in the first implantable hydraulic constriction element to a defined level. The method further comprises increasing the pressure in the second implantable hydraulic constriction element to a second defined level.
According to an aspect, a controller for controlling the pressure in an implantable pumping device for constricting the urinary bladder and for evacuating urine from the urinary bladder is provided. The controller comprises a pressure sensor for measuring the pressure in a first and/or second implantable hydraulic constriction element. The controller further comprises a computing unit. The computing unit is configured to create an absolute pressure by subtracting the pressure in the first and/or second implantable hydraulic constriction element, when substantially no pressure is exerted on the urinary bladder, from the pressure in the hydraulic constriction element, when the pressure in the first and/or second implantable hydraulic constriction element has been increased.
According to an aspect, an implantable pumping device for evacuating urine from the urinary bladder of a patient is provided. The implantable pumping device comprises a first constriction device configured to constrict a portion of the urinary bladder for closing a first portion of the urinary bladder. The implantable pumping device further comprises a second constriction device configured to constrict a second portion of the urinary bladder, downstream the first portion, for evacuating urine from the urinary bladder when the first portion of the urinary bladder is closed. The implantable pumping device further comprises a controller configured to control the first and second constriction device. The implantable pumping device further comprises a coating arranged on at least one surface of at least one of said first or second constriction device.
According to an aspect, a medical device for evacuating urine from the urinary bladder of a patient and configured to be held in position by a tissue portion of a patient is provided. The medical device comprises an implantable pumping device for evacuating urine from the urinary bladder of a patient. The implantable pumping device comprises a first constriction device configured to constrict a portion of the urinary bladder for closing a first portion of the urinary bladder. The implantable pumping device further comprises a second constriction device configured to constrict a second portion of the urinary bladder, downstream the first portion, for evacuating urine from the urinary bladder when the first portion of the urinary bladder is closed. The medical device further comprises an implantable energized medical device configured to be held in position by a tissue portion of a patient. The implantable energized medical device comprises a first portion configured to be placed on a first side of the tissue portion, the first portion having a first cross-sectional area in a first plane and comprising a first surface configured to face a first tissue surface of the first side of the tissue portion. The implantable energized medical device further comprises a second portion configured to be placed on a second side of the tissue portion, the second side opposing the first side, the second portion having a second cross-sectional area in a second plane and comprising a second surface configured to engage a second tissue surface of the second side of the tissue portion. The implantable energized medical device further comprises a connecting portion configured to be placed through a hole in the tissue portion extending between the first and second sides of the tissue portion, the connecting portion having a third cross-sectional area in a third plane and a fourth cross-sectional area in a fourth plane and a third surface configured to engage the first tissue surface of the first side of the tissue portion. The connecting portion is configured to connect the first portion to the second portion. The first, second, third and fourth planes are parallel to each other. The third cross-sectional area is smaller than the first, second and fourth cross-sectional areas, such that the first portion, second portion and connecting portion are prevented from travelling through the hole in the tissue portion in a direction perpendicular to the first, second and third planes. The first portion is detachably connected to at least one of the connecting portion and the second portion. The second portion is configured to connect to the implantable pumping device in a cadial direction.
An implantable energized medical device configured to be held in position by a tissue portion of a patient is provided, the medical device comprising: a first portion configured to be placed on a first side of the tissue portion, the first portion having a first cross-sectional area in a first plane and comprising a first surface configured to face a first tissue surface of the first side of the tissue portion, a second portion configured to be placed on a second side of the tissue portion, the second side opposing the first side, the second portion having a second cross-sectional area in a second plane and comprising a second surface configured to engage a second tissue surface of the second side of the tissue portion, and a connecting portion configured to be placed through a hole in the tissue portion extending between the first and second sides of the tissue portion, the connecting portion having a third cross-sectional area in a third plane and a third surface configured to engage the first tissue surface of the first side of the tissue portion, wherein the connecting portion is configured to connect the first portion to the second portion, wherein: the first, second, and third planes are parallel to each other, the third cross-sectional area is smaller than the second cross-sectional area, such that the first portion, second portion and connecting portion are prevented from travelling through the hole in the tissue portion in a direction perpendicular to the first, second and third planes, the first portion is configured to receive electromagnetic waves at a frequency above a frequency level, and/or to transmit electromagnetic waves at a frequency below the frequency level, wherein the second portion is configured to receive and/or transmit electromagnetic waves at a frequency below the frequency level, and wherein the frequency level is 100 kHz.
In some embodiments, wherein the first portion is configured to transmit electromagnetic waves at the frequency below the frequency level to the second portion.
In some embodiments, the first portion is configured to transmit electromagnetic waves at the frequency above the frequency level to an external device.
In some embodiments, the frequency level is 40 kHz or 20 kHz.
In some embodiments, the electromagnetic waves comprise wireless energy and/or wireless communication.
In some embodiments, the first portion comprises a first wireless energy receiver for receiving energy transmitted wirelessly by an external wireless energy transmitter above the frequency level, and an internal wireless energy transmitter configured to transmit energy wirelessly to the second portion below the frequency level, and the second portion comprises a second wireless energy receiver configured to receive energy transmitted wirelessly by the internal wireless energy transmitter below the frequency level.
In some embodiments, the first portion comprises a first controller comprising at least one processing unit.
In some embodiments, the second portion comprises a second controller comprising at least one processing unit.
In some embodiments, the first controller is connected to a first wireless communication receiver in the first portion for receiving wireless communication from an external device above the frequency level, the first controller is connected to a first wireless communication transmitter in the first portion for transmitting wireless communication to a second wireless communication receiver in the second portion below the frequency level.
In some embodiments, the second controller is connected to the second wireless communication receiver for receiving wireless communication from the first portion below the frequency level.
In some embodiments, the first portion comprises an outer casing made from a polymer material.
In some embodiments, the outer casing forms a complete enclosure, such that electromagnetic waves received and transmitted by the first portion must travel through the casing.
In some embodiments, the second portion comprises an outer casing made from titanium.
In some embodiments, the outer casing forms a complete enclosure, such that electromagnetic waves received and transmitted by the second portion must travel through the casing.
An implantable energized medical device configured to be held in position by a tissue portion of a patient is provided, the medical device comprising: a first portion configured to be placed on a first side of the tissue portion, the first portion having a first cross-sectional area in a first plane and comprising a first surface configured to face a first tissue surface of the first side of the tissue portion, a second portion configured to be placed on a second side of the tissue portion, the second side opposing the first side, the second portion having a second cross-sectional area in a second plane and comprising a second surface configured to engage a second tissue surface of the second side of the tissue portion, and a connecting portion configured to be placed through a hole in the tissue portion extending between the first and second sides of the tissue portion, the connecting portion having a third cross-sectional area in a third plane and a third surface configured to engage the first tissue surface of the first side of the tissue portion, wherein the connecting portion is configured to connect the first portion to the second portion, wherein: the first, second, and third planes are parallel to each other, the third cross-sectional area is smaller than the second cross-sectional area, such that the first portion, second portion and connecting portion are prevented from travelling through the hole in the tissue portion in a direction perpendicular to the first, second and third planes, the first portion is configured to receive and/or transmit electromagnetic waves at a frequency below the frequency level, and wherein the frequency level is 100 kHz.
In some embodiments, the second portion is configured to receive and/or transmit electromagnetic waves at a frequency below the frequency level.
In some embodiments, the first portion is configured to transmit electromagnetic waves at the frequency below the frequency level to the second portion.
In some embodiments, the first portion is configured to transmit electromagnetic waves at the frequency below the frequency level to an external device.
In some embodiments, the frequency level is 40 kHz or 20 kHz.
In some embodiments, the electromagnetic waves comprise wireless energy and/or wireless communication.
In some embodiments, the first portion comprises a first wireless energy receiver for receiving energy transmitted wirelessly by an external wireless energy transmitter below the frequency level, and an internal wireless energy transmitter configured to transmit energy wirelessly to the second portion below the frequency level, and the second portion comprises a second wireless energy receiver configured to receive energy transmitted wirelessly by the internal wireless energy transmitter below the frequency level.
In some embodiments, the first portion comprises a first controller comprising at least one processing unit.
In some embodiments, the second portion comprises a second controller comprising at least one processing unit.
In some embodiments, the first controller is connected to a first wireless communication receiver in the first portion for receiving wireless communication from an external device below the frequency level, the first controller is connected to a first wireless communication transmitter in the first portion for transmitting wireless communication to a second wireless communication receiver in the second portion below the frequency level.
In some embodiments, the second controller is connected to the second wireless communication receiver for receiving wireless communication from the first portion below the frequency level.
In some embodiments, the first portion comprises an outer casing made from a polymer material.
In some embodiments, the first portion comprises an outer casing made from titanium.
In some embodiments, the outer casing forms a complete enclosure, such that electromagnetic waves received and transmitted by the first portion must travel through the casing.
In some embodiments, the second portion comprises an outer casing made from titanium.
In some embodiments, the outer casing forms a complete enclosure, such that electromagnetic waves received and transmitted by the second portion must travel through the casing.
An implantable energized medical device configured to be held in position by a tissue portion of a patient is provided, the medical device comprising: a first portion configured to be placed on a first side of the tissue portion, the first portion having a first cross-sectional area in a first plane and comprising a first surface configured to face a first tissue surface of the first side of the tissue portion, a second portion configured to be placed on a second side of the tissue portion, the second side opposing the first side, the second portion having a second cross-sectional area in a second plane and comprising a second surface configured to engage a second tissue surface of the second side of the tissue portion, and a connecting portion configured to be placed through a hole in the tissue portion extending between the first and second sides of the tissue portion, the connecting portion having a third cross-sectional area in a third plane and a third surface configured to engage the first tissue surface of the first side of the tissue portion, wherein the connecting portion is configured to connect the first portion to the second portion, wherein: the first, second, and third planes are parallel to each other, the third cross-sectional area is smaller than the second cross-sectional area, such that the first portion, second portion and connecting portion are prevented from travelling through the hole in the tissue portion in a direction perpendicular to the first, second and third planes, the first portion is made from a polymer material, the second portion comprises a casing made from titanium, wherein the casing forms a complete enclosure.
In some embodiments, the casing of the second portion forms a complete enclosure such that the entirety of the outer surface of the second portion is covered by the casing, when the second portion is connected to the connecting portion.
In some embodiments, the first portion comprises a casing made from the polymer material.
In some embodiments, the casing of the first portion forms a complete enclosure such that the entirety of the outer surface of the first portion is covered by the casing.
In some embodiments, the connecting portion comprises a connection arranged to connect to the first and second portion respectively and carry electrical signals and/or energy.
In some embodiments, the connection is arranged in a core of the connecting portion such that it is encapsulated by outer material of the connecting portion.
In some embodiments, the connecting portion comprises a ceramic material.
In some embodiments, the connection is encapsulated within the ceramic material.
In some embodiments, the first portion comprises a first connection configured to connect to the connection of the connecting portion.
In some embodiments, the second portion comprises a second connection configured to connect to the connection of the connection portion.
In some embodiments, the casing of the second portion is hermetically sealed.
In some embodiments, the second connection is arranged such that the hermetical seal of the second portion is kept intact.
In some embodiments, the casing of the first portion is hermetically sealed.
An implantable energized medical device configured to be held in position by a tissue portion of a patient is provided, the medical device comprising: a first portion configured to be placed on a first side of the tissue portion, the first portion having a first cross-sectional area in a first plane and comprising a first surface configured to face a first tissue surface of the first side of the tissue portion, a second portion configured to be placed on a second side of the tissue portion, the second side opposing the first side, the second portion having a second cross-sectional area in a second plane and comprising a second surface configured to engage a second tissue surface of the second side of the tissue portion, and a connecting portion configured to be placed through a hole in the tissue portion extending between the first and second sides of the tissue portion, the connecting portion having a third cross-sectional area in a third plane and a third surface configured to engage the first tissue surface of the first side of the tissue portion, wherein the connecting portion is configured to connect the first portion to the second portion, wherein: the first, second, and third planes are parallel to each other, the third cross-sectional area is smaller than the second cross-sectional area, such that the first portion, second portion and connecting portion are prevented from travelling through the hole in the tissue portion in a direction perpendicular to the first, second and third planes, and wherein the connecting portion is configured to extend between the first portion and the second portion along a central extension axis, and wherein the second portion is configured to extend in a length direction being divergent with the central extension axis, and wherein the connecting portion has a substantially constant cross-sectional area along the central extension axis, or wherein the connecting portion has a decreasing cross-sectional area in a direction from the first portion towards the second portion along the central extension axis, and/or wherein the second portion has a substantially constant cross-sectional area along the length direction, or wherein the second portion has a decreasing cross-sectional area in the length direction.
In some embodiments, the third cross-sectional area is smaller than the first cross-sectional area.
In some embodiments, the connecting portion is tapered in the direction from the first portion towards the second portion along the central extension axis.
In some embodiments, the connecting portion has a circular or oval cross-section along the central extension axis with a decreasing diameter in the direction from the first portion towards the second portion.
In some embodiments, the second portion is tapered in the length direction.
In some embodiments, the connecting portion has a circular or oval cross-section in the length direction with a decreasing diameter in the length direction.
In some embodiments, the length direction extends from an interface between the connecting portion and the second portion towards an end of the second portion.
In some embodiments, the length direction extends in a direction substantially perpendicular to the central extension axis.
According to an aspect, a method of implanting a powered medical device is provided. The method comprises placing a second portion of an implantable energized medical device between a peritoneum and a layer of muscular tissue of the abdominal wall. The method further comprises placing a first portion of the implantable energized medical device between the skin of the patient and a layer of muscular tissue of the abdominal wall. The first and second portions are configured to be connected by a connecting portion extending through at least one layer of muscular tissue of the abdominal wall. The method further comprises placing a body engaging portion of the powered medical device in connection with a tissue or an organ of the patient which is to be affected by the powered medical device. The method further comprises placing a transferring member, configured to transfer at least one of energy and force from the second portion to the body engaging portion, at least partially between a peritoneum and a layer of muscular tissue of the abdominal wall, such that at least ⅓ of the length of the transferring member is placed on the outside of the peritoneum.
According to an aspect, an external device configured for communication with an implantable medical device, when implanted in a patient, is provided. The external device comprises at least one first wireless transceiver configured for communication with the implantable medical device using a first network protocol, for determining a distance between the external device and the implantable medical device, and at least one second wireless transceiver configured for communication with the implantable medical device using a second network protocol, for transferring data between the external device and the implantable medical device.
According to an aspect, an implantable medical device configured for communication with an external device is provided. The implantable medical device comprises at least one first wireless transceiver configured for communication with the external device using a first network protocol, for determining a distance between the external device and the implantable medical device, and at least one second wireless transceiver configured for communication with the external device using a second network protocol, for transferring data between the external device and the implantable medical device.
According to an aspect, a patient external device configured for communication with an implantable medical device, when implanted in a patient, is provided. The patient external device comprises a wireless communication unit configured for wireless transmission of control commands to the implantable medical device and configured for wireless communication with a patient display device, and a computing unit configured for running a control software for creating the control commands for the operation of the implantable medical device. The computing unit is configured to transmit a control interface as a remote display portal to a patient display device configured to display the control interface to a user, receive user input from the patient display device, and transform the user input into the control commands for wireless transmission to the implantable medical device.
According to an aspect, a patient display device for communication with a patient remote external device for communication with an implantable medical device is provided. The patient display device comprises a wireless communication unit configured for wirelessly receiving an implant control interface as a remote display portal from the patient remote external device and configured for wirelessly transmitting implant control user input to the patient remote external device, a display for displaying the received implant control interface, and an input device for receiving implant control input from the user.
According to an aspect, a communication system for enabling communication between a patient display device and an implantable medical device, when implanted, is provided. The communication system comprises: a patient display device, a server, and a patient remote external device. The patient display device comprises a wireless communication unit configured for wirelessly receiving an implant control interface as a remote display portal being provided by the patient remote external device. The wireless communication unit is further configured for wirelessly transmitting implant control user input to the server, destined for the patient remote external device. The system further comprises a display for displaying the received remote display portal, and an input device for receiving implant control input from the user, wherein the patient remote external device comprises a wireless communication unit configured for wireless transmission of control commands to the implantable medical device, and a computing unit. The computing unit is configured for running a control software for creating the control commands for the operation of the implantable medical device, transmitting a control interface to the patient display device, receiving implant control user input generated at the patient display device, from the server, and transforming the user input into the control commands for wireless transmission to the implantable medical device.
According to an embodiment, a patient display device for communication with a patient external device for communication with an implantable medical device, when implanted, is provided. The patient display device comprises a wireless communication unit, a display, and an input device for receiving implant control input from the user. The patient display device is configured to run a first application for wireless communication with a server and/or DDI, and run a second application for wireless communication with the patient external device for transmission of the implant control input to a remote display portal of the patient external device for the communication with the implantable medical device, wherein the second application is configured to be accessed through the first application. The patient display device comprises a first log-in function and a second log-in function, wherein the first log-in function gives the user access to the first application and wherein the first and second log-in function in combination gives the user access to the second application. The first log-in function may be configured to use at least one of a password, pin code, fingerprint, voice and face recognition. A second log-in function within the first application may be configured to use a private key from the user to authenticate, for a defined time period, a second hardware key of the patient external device.
According to an aspect, a communication system for enabling communication between a patient display device and an implantable medical device, when implanted, is provided. The communication system comprises a patient display device, a server or DDI, and a patient remote external device. The patient display device comprises a wireless communication unit configured for wirelessly receiving an implant control interface as a remote display portal from the patient remote external device, the wireless communication unit further being configured for wirelessly transmitting implant control user input to the patient remote external device, a display for displaying the received implant control interface as a remote display portal, and an input device for receiving implant control input from the user. The patient display device is configured to run a first application for wireless communication with the server, and to run a second application for wireless communication with the patient remote external device for transmission of the implant control input to the remote display portal of the patient remote external device for the communication with the implantable medical device. The patient remote external device comprises a wireless communication unit configured for wireless transmission of control commands based on the implant control input to the implantable medical device and configured for wireless communication with the patient display device.
According to an aspect, a computer program product is provided, configured to run in a patient display device comprising a wireless communication unit, a display for displaying the received implant control interface as a remote display portal, and an input device for receiving implant control input from a user. The computer program product comprises: a first application for communication with a server or DDI, a second application for communication with an patient remote external device for transmission of the implant control input via the remote display portal of the patient remote external device for the communication with an implantable medical device, wherein the second application is configured to be accessed through the first application, a first log-in function using at least one of a password, pincode, fingerprint, or face recognition, and a second log-in function within the first application, using a private key from the user to authenticate for a defined time period a second hardware key of the patient remote external device. The first log-in function gives the user access to the first application and the first and second log-in function in combination gives the user access to the second application.
According to an aspect, a communication system for enabling communication between a patient display device, a patient external device, a server and an implantable medical device, is provided. The communication system comprises a server, a patient display device, a patient external device, and an implantable medical device. The patient display device comprises a wireless communication unit for wirelessly communicating with at least one of the patient external device and the server, a display, and an input device for receiving input from the user. The patient external device comprises a wireless communication unit configured for wireless transmission of control commands to the implantable medical device and configured for wireless communication with at least one of the patient display device and the server. Further, the server comprises a wireless communication unit configured for wireless communication with at least one of the patient display device and the patient external device, wherein the implantable medical device comprises a wireless communication unit configured for wireless communication with the patient external device. The implantable medical device further comprises an encryption unit and is configured to: encrypt data destined for the server, transmit the data to the server via the patient external device, wherein the patient external device acts as a router transferring the data without full decryption. In an example, the implantable medical device comprises an encryption unit and is configured to: encrypt data destined for the patient display device, transmit the data to the patient display device via the patient external device, wherein the patient external device acts as a router transferring the data without full decryption. In an example, the server comprises an encryption unit and is configured to: encrypt data destined for the implantable medical device, transmit the data to the implantable medical device via the patient external device, wherein the patient external device acts as a router transferring the data without full decryption. In an example, the server comprises an encryption unit and is configured to: encrypt data destined for the implantable medical device, transmit the data to the implantable medical device via the patient display device and the patient external device, wherein the patient display device and the patient external device acts as a router transferring the data without full decryption. In an example, the patient display device comprises an encryption unit and is configured to: encrypt data destined for the implantable medical device, transmit the data to the implantable medical device via the patient external device, wherein the patient external device acts as a router transferring the data without full decryption. In an example, the patient display device comprises an encryption unit and is configured to: encrypt data destined for the implantable medical device, transmit the data to the implantable medical device via the server and the patient external device, wherein the server and the patient external device acts as a router transferring the data without full decryption.
According to an aspect, a server for use in the communication system according to any one of the above aspects or below embodiments is provided.
According to an aspect, a patient display device for use in the communication system according to any one of the above aspects or below embodiments is provided.
According to an aspect, a patient external device for use in the communication system according to any one of the above aspects or below embodiments is provided.
According to an aspect, an implantable medical device for use in the communication system according to any one of the above aspects or below embodiments is provided.
According to an aspect, a system configured for changing pre-programmed treatment settings of an implantable medical device, when implanted in a patient, from a distant remote location in relation to the patient, is provided. The system comprises at least one health care provider, HCP, EID external device, and a HCP private key device. HCP EID external device is adapted to receive a command from the HCP to change said pre-programmed treatment settings of an implanted medical device, and further adapted to be activated and authenticated and allowed to perform said command by the HCP providing the HCP private key device, wherein the HCP private key device is adapted to be provided to the HCP EID external device via at least one of: a reading slot or comparable for the HCP private key device, and a RFID communication or other close distance wireless activation communication. The HCP EID external device comprises at least one of: a reading slot or comparable for the HCP private key device, a RFID communication, and other close distance wireless activation communication or electrical direct contact. The HCP EID external device further comprises at least one wireless transceiver configured for communication with a data infrastructure server, DDI, through a first network protocol. Further, the system comprises a data infrastructure server, DDI, adapted to receive command from said HCP EID external device and to relay the received command without modifying said command to a patient EID external device, wherein the DDI comprises one wireless transceiver configured for communication with said patient external device, and a patient EID external device adapted to receive the command relayed by the DDI, further adapted to send this command to the implanted medical device, further adapted to receive a command from the HCP EID external device via the DDI to change said pre-programmed treatment settings of the implanted medical device, and further adapted to be activated and authenticated and allowed to perform said command by the patient providing a patient private key device adapted to be provided to the patient EID external device by the patient via at least one of: a reading slot or comparable for the patient private key device, a RFID communication or other close distance wireless activation communication or electrical direct contact. The patient EID external device comprises at least one of a reading slot or comparable for the HCP private key device, a RFID communication, and other close distance wireless activation communication or electrical direct contact. The patient EID external device further comprises at least one wireless transceiver configured for communication with the implanted medical device through a second network protocol. Further, the implanted medical device is configured to treat the patient or perform a bodily function.
According to an aspect, a system is provided, configured for changing pre-programmed treatment settings of an implantable medical device, when implanted in a patient, by a health care provider, HCP, in the physical presence of the patient. The system comprises at least one HCP EID external device adapted to receive a command from the HCP, directly or indirectly, to change said pre-programmed treatment settings in steps of an implantable medical device, when implanted, wherein the HCP EID external device is further adapted to be activated, authenticated, and allowed to perform said command by the HCP providing an HCP private key device comprising a HCP private key. The HCP private key device comprises at least one of: a smart card, a keyring device, a watch, a arm or wrist band, a necklace, and any shaped device. The HCP EID external device is adapted to be involved in at least one of: receiving information from the implant, receiving information from a patient remote external device, actuating the implanted medical device, changing pre-programmed settings, and updating software of the implantable medical device, when implanted. The HCP EID external device is further adapted to be activated, authenticated, and allowed to perform said command also by the patient. The system further comprises a patient private key device comprising a patient private key, wherein the patient private key device comprising at least one of: a smart card, a keyring device, a watch, a arm or wrist band, a necklace, and any shaped device. The HCP private key and the patient private key are required for performing said actions by the HCP EID external device to at least one of: receive information from the implant, to receive information from a patient remote external device, to actuate the implanted medical device, to change pre-programmed settings, and to update software of the implantable medical device, when the implantable medical device is implanted.
According to an aspect, a system is provided, configured to change pre-programmed and pre-selected treatment actions of an implantable medical device, when implanted in a patient, by command from the patient. The system comprises an implantable medical device, a patient remote external device, a wireless transceiver configured for communication with the implantable medical device, when the medical device is implanted, through a second network protocol, and a remote display portal. The remote display portal is configured to receive content delivered from the patient remote external device to expose buttons to express the will to actuate the functions of the implanted medical device by the patient through the patient remote external device, and further configured to present the display portal remotely on a patient display device allowing the patient to actuate the functions of the implanted medical device through the display portal of the patient remote external device visualised on the patient display device.
According to an aspect, a system is provided, configured for providing information from an implantable medical device, when implanted in a patient, from a distant remote location in relation to the patient. The system comprises at least one patient EID external device adapted to receive information from the implant, adapted to send such information further on to a server or dedicated data infrastructure, DDI, further adapted to be activated and authenticated and allowed to receive said information by the implanted medical device by the patient providing a private key. Further, the system comprises a patient private key device comprising the private key adapted to be provided to the patient EID external device via at least one of: a reading slot or comparable for the patient private key device, a RFID communication or other close distance wireless activation communication or direct electrical connection. The patient EID external device comprises at least one of: a reading slot or comparable for the patient private key device, an RFID communication, and other close distance wireless activation communication or direct electrical contact. Further, the patient EID external device comprises at least one wireless transceiver configured for communication with the DDI, through a first network protocol.
According to an aspect, a system is provided, comprising, an implantable medical device adapted to, when implanted in a patient, to communicate with an external device, the external device comprising at least one of a patient remote external device or a patient EID external device. The system further comprises the patient EID external device adapted to communicate with and send commands to the implantable medical device when implanted, to change pre-programmed settings, and a patient private key device comprising a patient private key, adapted to activate and authenticate and allow to perform said command by the patient EID external device, wherein said private key is adapted to be provided to the external device via at least one of: a reading slot or comparable for the HCP private key device, an RFID communication or other close distance wireless activation communication, or direct electrical contact. Further the system comprises a data infrastructure server, DDI, adapted to send commands to the patient EID external device for further transport to the implanted medical device, to inactivate the authority and authenticating function of the patient private key.
According to an aspect, a system is provided, configured for changing pre-programmed treatment settings in steps of an implantable medical device, when implanted in a patient, by a health care provider, HCP, either in the physical presence of the patient or remotely with the patient on distance. The system comprises at least one HCP EID external device adapted to receive a command directly or indirectly from the HCP to change said pre-programmed treatment settings in steps of the implantable medical device, when implanted. The HCP EID external device is further adapted to be activated, authenticated, and allowed to perform said command by the HCP providing a HCP private key device comprising a HCP private key. The HCP private key comprises at least one of: a smart card, a keyring device, a watch, an arm or wrist band, a necklace, and any shaped device. The system further comprises a patient private key device comprising a patient private key, comprising at least one of: a smart card, a keyring device, a watch, an arm or wrist band, a necklace, and any shaped device. Both the HCP and patient private key is required for performing said action by the HCP EID external device to change the pre-programmed settings in the implant and to update software of the implantable medical device, when the implantable medical device is implanted. The patient private key is adapted to activate, be authenticated, and allowed to perform said command provided by the HCP, either via the HCP EID external device or when the action is performed remotely via a patient EID external device.
According to an aspect, a system is provided, configured for changing pre-programmed treatment settings in steps of an implantable medical device, when implanted in a patient, by a health care provider, HCP, with the patient on remote on distance. The system comprises at least one HCP EID external device adapted to receive a command from the HCP direct or indirect, to change said pre-programmed treatment settings in steps of an implantable medical device, when implanted, wherein the HCP EID external device is further adapted to be activated, authenticated, and allowed to perform said command by the HCP. The action by the HCP EID external device to change pre-programmed settings in the implant and to update software of the implantable medical device, when the implantable medical device is implanted, is adapted to be authenticated by a HCP private key device and a patient private key device.
According to an aspect, a system is provided, which is configured for changing pre-programmed treatment settings of an implantable medical device, when implanted in a patient, from a distant remote location in relation to the patient. The system comprises at least one health care provider, HCP, external device adapted to receive a command from the HCP to change said pre-programmed treatment settings of an implanted medical device. The HCP external device is further adapted to be activated and authenticated and allowed to perform said command by the HCP providing a HCP private key device adapted to be provided to an HCP EID external device via at least one of; a reading slot or comparable for the HCP private key device, a RFID communication or other close distance wireless activation communication. The HCP EID external device comprises at least one of: a reading slot or comparable for the HCP private key device, a RFID communication, and other close distance wireless activation communication or electrical direct contact. The HCP EID external device further comprises at least one wireless transceiver configured for communication with a patient EID external device, through a first network protocol. The system comprises the patient EID external device, the patient EID external device being adapted to receive command from said HCP external device, and to relay the received command without modifying said command to the implanted medical device. The patient EID external device comprises one wireless transceiver configured for communication with said patient external device, wherein the patient EID is adapted to send the command to the implanted medical device, to receive a command from the HCP to change said pre-programmed treatment settings of the implanted medical device, and further to be activated and authenticated and allowed to perform said command by the patient providing a patient private key device comprising a patient private key.
According to an embodiment, the controller is configured to control the first and second constriction device such that the first constriction device closes the first portion of the urinary bladder. And such that the second constriction device constricts the second portion of the urinary bladder for evacuating urine from the urinary bladder when the first portion of the urinary bladder is closed.
According to an embodiment, the controller is configured to receive a pressure signal from a pressure sensor configured to measure the pressure in or exerted by at least one of the first and second constriction devices.
According to an embodiment, at least one of the first and second constriction device is a hydraulic constriction device.
According to an embodiment, at least one of the first and second constriction device is a constriction device configured to constrict by electrically stimulating at least one tissue wall of the urinary bladder.
According to an embodiment, the second constriction device is configured to constrict the second portion of the urinary bladder using electrical stimulation. And the implantable pumping device further comprises a cancellation unit configured to be placed downstream the second portion. The cancellation unit being configured to cancel the electrical stimulation such that the urinary sphincter remains substantially unaffected by the electrical stimulation.
According to an embodiment, the first constriction device is configured to constrict the first portion of the urinary bladder extending a first distance axially in the direction of the flow of urine. And the second constriction device is configured to constrict the second portion of the urinary bladder extending a second distance axially in the direction of the flow of urine. The second distance is at least two times as long as the first distance.
According to an embodiment, at least one of the first and second constriction device comprises at least one constriction element configured to contact a first portion of the urinary bladder. And at least one abutment configured to contact a second portion of the urinary bladder and for withholding the force from the at least one constriction element, such that the urinary bladder is constricted between the at least one constriction element and the abutment.
According to an embodiment, at least one of the first and second constriction device comprises at least a first and a second constriction element. The first constriction element is configured to contact a first portion of the urinary bladder and the second constriction element is configured to contact a second portion of the urinary bladder. This such that the urinary bladder is constricted between the first and second constriction elements.
According to an embodiment, the implantable pumping device further comprises a support element. And the at least one of the at least one constriction element and the at least one abutment is connected to the support element.
According to an embodiment, the support element is configured to form at least a portion of a surrounding structure configured to surround the urinary bladder.
According to an embodiment, the support element comprises at least one fluid conduit at least partially integrated in the support element.
According to an embodiment, the support element comprises a connection portion for connecting the support element to another support element for at least partially forming the surrounding structure.
According to an embodiment, the support element comprises a portion of a hinge for hingedly connecting the support element to other support element for at least partially forming the surrounding structure.
According to an embodiment, the at least one of the support elements, the at least one abutment and the at least one constriction element comprises at least one curvature adapted for the curvature of the urinary bladder.
According to an embodiment, the implantable pumping device further comprises an electrode arrangement configured to engage and electrically stimulate muscle tissue of the urinary bladder to exercise the muscle tissue to improve the conditions for long term implantation of the implantable pumping device.
According to an embodiment, the abutment comprises at least one cushioning element configured to contact the urinary bladder, wherein the cushioning element is more resilient than the support element.
According to an embodiment, the first constriction device comprises a first curvature having a first radius adapted for a curvature of the urinary bladder. And the second constriction device comprises a second curvature having a second radius adapted for a curvature of the urinary bladder. The first radius may be smaller than the second radius.
According to an embodiment, the first constriction device may have an aperture in a non-constricting state that is larger than an aperture of the second constriction device in a non-constricting state, so that the first constriction device may surround first a portion of the bladder having a larger cross-section than a second portion which the second constriction device may surround.
In one embodiment, the aperture of the first constriction device has an inner diameter of about 5-12 cm preferably about 8-11 cm in a non-constricted state, so as to house a bladder with corresponding size. With diameter is meant the cross-sectional opening in this context, and it does not need to be a perfect circular aperture, but rather an aperture to fit the bladder.
In one embodiment, the aperture of the second constriction device has an inner diameter of about 1-8 cm preferably about 2-5 cm in a non-constricted state, so as to house a bladder with corresponding size.
According to an embodiment, the second constriction device comprises a plurality of constriction elements configured to sequentially constrict the urinary bladder for evacuating urine from the urinary bladder.
According to an embodiment, the mechanical construction device comprises at least one mechanical constriction element comprising an electric motor, a screw and a plate. The electric motor is configured to turn the screw in order to push the plate toward the urinary bladder in order to constrict the urinary bladder.
According to an embodiment, the implantable pumping device further comprises electric stimulation device comprising electrodes provided on the constriction elements and configured to electrically stimulate the constricted portions with electric pulses.
According to an embodiment, the electrodes are configured to stimulate the tissue of the urinary bladder in order to avoid damage to the tissue from the pressure of the constriction elements.
According to an embodiment, the electrodes are configured to stimulate the tissue of the urinary bladder in order to thicken the tissue of the constricted portion in order to close the passageway of the urinary bladder.
According to an embodiment, the implantable pumping device further comprises a cancellation unit configured to be placed downstream the rotor and the constriction elements, the cancellation unit being configured to cancel the electrical stimulation such that the urinary sphincter remains substantially unaffected by the electrical stimulation.
According to an embodiment, a lumen of the first operable hydraulic constriction element has a larger volume than a lumen of the second operable hydraulic constriction element.
According to an embodiment, the lumen of the first operable hydraulic constriction element has a volume which is more than 1,5 times larger than the volume of the lumen of the second operable hydraulic constriction element.
According to an embodiment, the first interconnecting fluid conduit comprises a first electrically operable valve, such that a flow of fluid between the first operable hydraulic constriction element and the second operable hydraulic constriction element can be controlled.
According to an embodiment, the electrically operable valve is a solenoid valve.
According to an embodiment, the first interconnecting fluid conduit comprises a check valve, such that fluid can flow in a direction from the first operable hydraulic constriction element to the second operable hydraulic constriction element but not in a direction from the second operable hydraulic constriction element to the first operable hydraulic constriction element.
According to an embodiment, the implantable pumping device further comprises a second interconnecting fluid conduit fluidly connecting the first operable hydraulic constriction element to the second operable hydraulic constriction element, wherein a cross section of a tubular lumen of the second interconnecting fluid conduit has an area which is less than 0.5 times a cross section area of a tubular lumen of the first interconnecting fluid conduit.
According to an embodiment, the implantable pumping device further comprises a hydraulic pump, a reservoir for holding hydraulic fluid, and a first reservoir conduit, fluidly connecting the reservoir to the first operable hydraulic constriction element. The hydraulic pump is configured to pump fluid from the reservoir to the first operable hydraulic constriction element through the first reservoir conduit, for constricting the first portion of the urinary bladder for restricting the flow of fluid therethrough.
According to an embodiment, the first reservoir conduit comprises a second electrically operable valve, such that a flow of fluid between the reservoir and the first operable hydraulic constriction element can be controlled.
According to an embodiment, the implantable pumping device further comprises a second reservoir conduit fluidly connecting the reservoir to the second operable hydraulic constriction element.
According to an embodiment, the second reservoir conduit comprises a check valve such that fluid can flow in a direction from the reservoir to the second operable hydraulic constriction element but not in a direction from the second operable hydraulic constriction element to the reservoir.
According to an embodiment, the implantable pumping device further comprises an injection port in fluid connection with the reservoir, for injecting fluid into the reservoir when the reservoir is implanted.
According to an embodiment, the injection port is configured to be placed subcutaneously, and wherein the implantable pumping device further comprises an injection port conduit fluidly connecting the injection port to the reservoir.
According to an embodiment, the implantable pumping device further comprising at least one of: a first pressure sensor configured to sense the pressure in the first operable hydraulic constriction element, and a second pressure sensor configured to sense the pressure in the second operable hydraulic constriction element.
According to an embodiment, the implantable pumping device further comprises a controller configured to receive a pressure sensor signal from at least one of the first and second pressure sensor, and control at least one of: the first electrically operable valve, the second operable valve and the hydraulic pump, on the basis of the received pressure sensor signal
According to an embodiment, the controller comprises a pressure threshold value, and wherein the controller is configured to open the first electrically operable valve if the received pressure sensor signal from the second pressure sensor exceeds the pressure threshold value.
According to an embodiment, the implantable pumping device further comprising further a supporting operable hydraulic constriction element. The supporting operable hydraulic constriction element is configured to be placed along at least a portion of the first portion of the luminary organ and along at least a portion of the second portion of the luminary organ. The supporting operable hydraulic constriction element is configured to assist in the constriction of the first and second portions of the urinary bladder.
According to an embodiment, the supporting operable hydraulic constriction element is connected to the first and second operable hydraulic constriction elements.
According to an embodiment, the supporting operable hydraulic constriction element is less resilient than at least one of the first and second operable hydraulic constriction element.
According to an embodiment, each of the first, second and supporting operable hydraulic constriction element comprises a lumen surrounded by a resilient wall. The resilient wall of the supporting operable hydraulic constriction element is thicker than the wall of at least one of the first and second operable hydraulic constriction element.
According to an embodiment, the implantable pumping device further comprises a second hydraulic pump, a second reservoir for holding hydraulic fluid, and a supporting reservoir conduit, fluidly connecting the second reservoir to the supporting operable hydraulic constriction element. The second hydraulic pump is configured to pump fluid from the second reservoir to the supporting operable hydraulic constriction element through the supporting reservoir conduit, for assisting in the constriction of the luminary organ.
According to an embodiment, the implantable pumping device further comprises a third pressure sensor configured to sense the pressure in the supporting operable hydraulic constriction element.
According to an embodiment, the implantable pumping device further comprises a second injection port in fluid connection with the second reservoir, for injecting fluid into the second reservoir when the second reservoir is implanted.
According to an embodiment, the second injection port is configured to be placed subcutaneously. The implantable pumping device further comprises a second injection port conduit fluidly connecting the second injection port to the second reservoir.
According to an embodiment, the supporting operable hydraulic constriction element has a length in the axial direction of the urinary bladder, when implanted. The first and second operable hydraulic constriction element has a combined length in the axial direction AD of the urinary bladder, and wherein the combined length is longer than the length of the supporting operable hydraulic constriction element.
According to an embodiment, the implantable pumping device further comprises a surrounding structure having a periphery surrounding the urinary bladder when implanted.
According to an embodiment, the surrounding structure is substantially rigid.
According to an embodiment, a major portion of the surrounding structure is made from a material having a modulus of elasticity in the range 0,2 GPa-1000 GPa or in the range 1 GPa-400 GPa.
According to an embodiment, the surrounding structure has a modulus of elasticity, radially, in the range 0,2 GPa-1000 GPa or in the range 1 GPa-400 GPa.
According to an embodiment, the surrounding structure comprises an inner surface configured to face the urinary bladder, when implanted, and wherein the supporting operable hydraulic constriction device is fixated to the inner surface of the surrounding structure, such that the supporting operable hydraulic constriction device can use the surrounding structure as support for constricting the urinary bladder.
According to an embodiment, the implantable pumping device further comprises at least one cushioning element configured to contact the urinary bladder, wherein the cushioning element is fixated to the inner surface of the surrounding structure and is more resilient than the surrounding structure.
According to an embodiment, the surrounding structure is comprised of at least a first and a second supporting element configured to be connected to each other for forming at least a portion of the periphery of the surrounding structure.
According to an embodiment, the supporting operable hydraulic constriction device is fixated to the first supporting element, and the at least one cushioning element is fixated to the second supporting element.
According to an embodiment, at least one of the first and second supporting elements have a curvature adapted for the curvature of the urinary bladder.
According to an embodiment, the curvature has a radius in the range 15 mm-60 mm.
According to an embodiment, the curvature has a radius in the range 20 mm-50 mm.
According to an embodiment, the supporting operable hydraulic constriction element is connected to the first operable hydraulic constriction element.
According to an embodiment, the supporting operable hydraulic constriction element is less resilient than the first operable hydraulic constriction element.
According to an embodiment, the first operable hydraulic constriction element comprises a lumen surrounded by a resilient wall and the supporting operable hydraulic constriction element comprises a lumen surrounded by a resilient wall, and wherein a portion of the resilient wall of the supporting operable hydraulic constriction element is thicker than a portion of the resilient wall of the first operable hydraulic constriction element.
According to an embodiment, a portion of the resilient wall of the supporting operable hydraulic constriction element is more than 1,5 times thicker than a portion of the resilient wall of the first operable hydraulic constriction element.
According to an embodiment, a portion of the resilient wall of the supporting operable hydraulic constriction element is more than 2 times thicker than a portion of the resilient wall of the first operable hydraulic constriction element.
According to an embodiment, the first operable hydraulic constriction element comprises a lumen surrounded by a resilient wall. The supporting operable hydraulic constriction element comprises a lumen surrounded by a resilient wall. A portion of the resilient wall of the first operable hydraulic constriction element comprises a first material. A portion of the resilient wall of the supporting operable hydraulic constriction element comprises a second material. The second material has a modulus of elasticity which is higher than a modulus of elasticity of the first material
According to an embodiment, the modulus of elasticity of the second material is more than 1,5 times higher than the modulus of elasticity of the first material.
According to an embodiment, the modulus of elasticity of the second material is more than 2 times higher than the modulus of elasticity of the first material.
According to an embodiment, the implantable pumping device further comprises a first hydraulic pump. The implantable pumping device further comprises a second hydraulic pump. The implantable pumping device further comprises a first reservoir for holding hydraulic fluid. The implantable pumping device further comprises a second reservoir for holding hydraulic fluid. The implantable pumping device further comprises a first reservoir conduit, fluidly connecting the first reservoir to the first operable hydraulic constriction element. The implantable pumping device further comprises a supporting reservoir conduit, fluidly connecting the second reservoir to the supporting operable hydraulic constriction element. The first hydraulic pump is configured to pump fluid from the first reservoir to the first operable hydraulic constriction element through the first reservoir conduit, for constricting the urinary bladder. The second hydraulic pump is configured to pump fluid from the second reservoir to the supporting operable hydraulic constriction element through the supporting reservoir conduit, for assisting in the constriction of the urinary bladder.
According to an embodiment, the implantable pumping device further comprises a second pressure sensor configured to sense the pressure in the supporting operable hydraulic constriction element.
According to an embodiment, the implantable pumping device further comprises an implantable controller. The implantable controller is configured to control at least one of the first hydraulic pump on the basis of input from the first pressure sensor, and the second hydraulic pump on the basis of input from the second pressure sensor.
According to an embodiment, at least one of the first reservoir conduit comprises an electrically operable valve, and the second reservoir conduit comprises an electrically operable valve. The controller is configured to control at least one of the electrically operable valve on the first reservoir conduit, on the basis of input from the first pressure sensor, and the electrically operable valve on the second reservoir conduit, on the basis of input from the second pressure sensor.
According to an embodiment, at least one of: the first reservoir conduit comprises a check valve, and the second reservoir conduit comprises a check valve.
According to an embodiment, the implantable pumping device further comprises a first injection port in fluid connection with the first reservoir, for injecting fluid into the first reservoir when the first reservoir is implanted.
According to an embodiment, the implantable pumping device further comprises a second injection port in fluid connection with the second reservoir, for injecting fluid into the second reservoir when the second reservoir is implanted.
According to an embodiment, at least one of: the first injection port is configured to be placed subcutaneously, and wherein the implantable constriction device further comprises a first injection port conduit fluidly connecting the first injection port to the first reservoir, and the second injection port is configured to be placed subcutaneously, and wherein the implantable constriction device further comprises a second injection port conduit fluidly connecting the second injection port to the second reservoir.
According to an embodiment, the supporting operable hydraulic constriction element has a length in the axial direction of the urinary bladder, when implanted, and wherein the first operable hydraulic constriction element has a length in the axial direction of the urinary bladder, and wherein the length of the first operable hydraulic constriction element is longer than the length of the supporting operable hydraulic constriction element.
According to an embodiment, the supporting operable hydraulic constriction device is fixated to the first supporting element, and the at least one cushioning element is fixated to the second supporting element.
According to an embodiment, at least one of the first and second supporting element have a curvature adapted for the curvature of the urinary bladder.
According to an embodiment, the second distance is substantially opposite to the first direction.
According to an embodiment, the first hydraulic system comprises a first hydraulic pump. The second hydraulic system comprises a second hydraulic pump. The third hydraulic system comprises a third hydraulic pump. The fourth hydraulic system comprises a fourth hydraulic pump.
According to an embodiment, the preceding aspects, wherein each of the first, second, third and fourth hydraulic systems comprises a reservoir for holding hydraulic fluid.
According to an embodiment, the first, second, third and fourth hydraulic systems are connected to a reservoir for holding hydraulic fluid.
According to an embodiment, each of the first, second, third and fourth hydraulic systems comprises an injection port for injecting hydraulic fluid into the respective first and second hydraulic systems.
According to an embodiment, the injection ports is configured to be placed subcutaneously, and wherein the implantable pumping device further comprises an injection port conduit fluidly connecting the injection ports (108) to the first, second, third and fourth hydraulic systems.
According to an embodiment, the first operable hydraulic constriction element lacks a fluid connection to the second operable hydraulic constriction element, and wherein the third operable hydraulic constriction element lacks a fluid connection to the fourth operable hydraulic constriction element.
According to an embodiment, the implantable pumping device comprises at least one of: a first pressure sensor configured to sense the pressure in the first operable hydraulic constriction element. a second pressure sensor configured to sense the pressure in the second operable hydraulic constriction element. a third pressure sensor configured to sense the pressure in the third operable hydraulic constriction element. a fourth pressure sensor configured to sense the pressure in the fourth operable hydraulic constriction element.
According to an embodiment, the implantable pumping device comprises a controller configured to receive a pressure sensor signal from at least one of the first, second, third and fourth pressure sensor. The control unit is configured to control at least one of: the first hydraulic pump, the second hydraulic pump, the third hydraulic pump and the fourth hydraulic pump on the basis of the received pressure sensor signal.
According to an embodiment, the surrounding structure comprises an inner surface configured to face the urinary bladder, when implanted, and wherein the first, second, third and fourth operable hydraulic constriction element are fixated to the inner surface of the surrounding structure.
According to an embodiment, the surrounding structure is comprised of at least a first and a second support element configured to be connected to each other for forming at least a portion of the periphery of the surrounding structure.
According to an embodiment, the first and third operable hydraulic constriction elements are fixated to the first support element. The second and fourth operable hydraulic constriction elements are fixated to the second support element.
According to an embodiment, the electrode arrangement is arranged on an outer surface of at least one of the first operable hydraulic constriction element and the second operable hydraulic constriction element.
According to an embodiment, the electrode arrangement comprises a plurality of electrode elements, each of which being configured to engage and electrically stimulate tissue of the urinary bladder.
According to an embodiment, the electrode arrangement comprises a coiled wire for increasing a contact surface between the electrode arrangement and the tissue of the urinary bladder and for allowing the electrode arrangement to follow contraction and relaxation of the tissue of the urinary bladder.
According to an embodiment, the electrode arrangement comprises a bare electrode portion configured to form a metal-tissue interface with the tissue of the urinary bladder, thereby allowing faradaic charge transfer to the be predominant charge transfer mechanism over the interface.
According to an embodiment, the electrode arrangement comprises an electrode portion at least partly covered by a dielectric material configured to form a dielectric-tissue interface with the tissue of the urinary bladder, thereby allowing for a faradaic portion of the charge transfer mechanism over said interface to be reduced.
According to an embodiment, the electrode arrangement comprises at least two electrode elements configured to be arranged on opposing sides of the urinary bladder.
According to an embodiment, the implantable pumping device further comprises a stimulation controller configured to be operably connected to the electrode arrangement for controlling the electrical stimulation of the tissue of the urinary bladder.
According to an embodiment, wherein the stimulation controller is configured to control the electrical stimulation such that the tissue of the urinary bladder is stimulated by a series of electrical pulses.
According to an embodiment, the stimulation controller is configured to control the electrical stimulation such that a pulse of a first polarity is followed by a pulse of a second, reversed polarity.
According to an embodiment, the stimulation controller is configured to generate a pulsed electrical stimulation signal comprising a pulse frequency of 0.01-150 Hz.
According to an embodiment, the electrical stimulation signal comprises a pulse duration of 0.01-100 ms.
According to an embodiment, the electrical stimulation signal comprises a pulse amplitude of 1-15 mA.
According to an embodiment, the electrical stimulation signal comprises a pulse frequency of 0.15-0.25 Hz, a pulse duration of 20-30 ms and a pulse amplitude of 3-10 mA.
According to an embodiment, the electrical stimulation signal comprises a build-up period of 0.01-2 s in which the amplitude is gradually increasing, a stimulation period of 1-60 s, and a stimulation pause of 0.01-60 s, wherein the electrical signal comprises a pulse frequency of 1-50 Hz and a pulse duration of 0.1-10 ms.
According to an embodiment, the stimulation controller is configured to receive input from a wireless remote control.
According to an embodiment, the implantable pumping device further comprises an implantable sensor configured to sense actions potentials generated by pacemaker cells of the tissue of the urinary bladder, and wherein the stimulation controller is configured to control the electrical simulation based at least partly on the sensed action potentials.
According to an embodiment, the stimulation controller is configured to generate electrical pulses amplifying the sensed action potentials.
According to an embodiment, the surrounding structure comprises at least one cushioning element. At least one electrode element of the electrode arrangement is placed on the surface of the cushioning element.
According to an embodiment, the motor of the first and/or second constriction device is an electrical motor.
According to an embodiment, the motor is a brushless implantable DC motor.
According to an embodiment, the implantable pumping device further comprises a gear system placed between the motor and the first and second hydraulic pump, and wherein the gear system is configured to reduce the velocity and increase the force of the movement generated by the motor for propelling the first and second hydraulic pump with a mechanical force with a lower velocity and a greater force
According to an embodiment, the motor is configured to generate a rotating force and propel the first and second hydraulic pump with a rotating mechanical force.
According to an embodiment, a rotating force output of the motor is connected to a force input of the gear system. And a rotating force output of the gear system is connected to the first and second hydraulic pump.
According to an embodiment, at least one of the first and second hydraulic pump of the first constriction device and/or the second constriction device comprises a gear pump.
According to an embodiment, at least one of the first and second hydraulic pump of the first constriction device and/or the second constriction device comprises a peristaltic pump.
According to an embodiment, at least one of the first and second hydraulic pump of the first constriction device and/or the second constriction device comprises a pump comprising at least one compressible hydraulic reservoir.
According to an embodiment, at least one of the first and second hydraulic pump of the first constriction device and/or the second constriction device comprises a gerotor pump.
According to an embodiment, the first hydraulic pump comprises a first gerotor pump. The second hydraulic pump comprises a second gerotor pump. The first constriction device and/or the second constriction device further comprises a common rotating shaft mechanically connected to the motor. An inner rotor of the first gerotor pump is mechanically connected to the common rotating shaft. An inner rotor of the second gerotor pump is mechanically connected to the common rotating shaft, such that the motor propels the first and second gerotor pump.
According to an embodiment, the implantable pumping device further comprises an implantable reservoir. At least one of the first and second hydraulic pump of the first constriction device and/or the second constriction device is connected to the implantable reservoir.
According to an embodiment, the first constriction device and/or the second constriction device further comprises a first implantable reservoir (107) and a second implantable reservoir. And the first hydraulic pump is connected to the first implantable reservoir. And the second hydraulic pump is connected to the second implantable reservoir.
According to an embodiment, the first constriction device and/or the second constriction device further comprises an implantable reservoir. The first and second hydraulic pump is connected to the implantable reservoir, for pumping hydraulic fluid from the first reservoir to the first operable hydraulic constriction element and from the second reservoir to the second operable hydraulic constriction elements
According to an embodiment, the first operable hydraulic constriction element of the first constriction device is configured to be inflated and thereby expand in a first direction towards the urinary bladder to constrict a first portion of the luminary organ for restricting the flow of fluid therethrough. The second operable hydraulic constriction element of the first constriction device is a supporting operable hydraulic constriction element configured to be inflated and thereby expand in the first direction towards the urinary bladder to support the first operable hydraulic constriction element in constricting the first portion of the urinary bladder for restricting the flow of fluid therethrough.
According to an embodiment, the first operable hydraulic constriction element of the second constriction device is configured to be inflated and thereby expand in a first direction towards the urinary bladder to constrict a second portion of the luminary organ for restricting the flow of fluid therethrough and for evacuating urine from the urinary bladder. The second operable hydraulic constriction element of the second constriction device is a supporting operable hydraulic constriction element configured to be inflated and thereby expand in the first direction towards the urinary bladder to support the first operable hydraulic constriction element in constricting the first portion of the urinary bladder for restricting the flow of fluid therethrough and for evacuating urine from the urinary bladder.
According to an embodiment, the supporting operable hydraulic constriction element is connected to the first operable hydraulic constriction element.
According to an embodiment, the supporting operable hydraulic constriction element is less resilient than the first operable hydraulic constriction element.
According to an embodiment, the first operable hydraulic constriction element of the first constriction device and/or the second constriction device comprises a lumen surrounded by a resilient wall. The supporting operable hydraulic constriction element comprises a lumen surrounded by a resilient wall. A portion of the resilient wall of the supporting operable hydraulic constriction element is thicker than a portion of the resilient wall of the first operable hydraulic constriction element
According to an embodiment, first constriction device and/or the second constriction device further comprises a first pressure sensor configured to sense the pressure in the first operable hydraulic constriction element.
According to an embodiment, the first constriction device and/or the second constriction device further comprises a second pressure sensor configured to sense the pressure in the second operable hydraulic constriction element.
According to an embodiment, the implantable pumping device further comprises an implantable controller. The implantable controller is configured to control at least one of the: first hydraulic pump of the first constriction device and/or the second constriction device on the basis of input from the first pressure sensor. And the second hydraulic pump of the first constriction device and/or the second constriction device on the basis of input from the second pressure sensor
According to an embodiment, the first constriction device and/or the second constriction device further comprises a first implantable injection port in fluid connection with the first operable hydraulic constriction element.
According to an embodiment, the first constriction device and/or the second constriction device further comprises a second implantable injection port in fluid connection with the second operable hydraulic constriction element.
According to an embodiment, the implantable energy storage unit is a re-chargeable battery.
According to an embodiment, the implantable energy storage unit is a solid-state battery.
According to an embodiment, the battery is a tionyl-chlorid battery.
According to an embodiment, the implantable energy storage unit is connected to at least one of the first and second hydraulic pump and configured to power the first and/or second hydraulic pump after it has been started using the capacitor.
According to an embodiment, the capacitor is configured to store energy to provide a burst of energy to at least one of the first and second hydraulic pump.
According to an embodiment, the capacitor is a start capacitor.
According to an embodiment, the capacitor is a run capacitor.
According to an embodiment, the capacitor is a dual run capacitor.
According to an embodiment, the implantable pumping device further comprises a second capacitor configured to be charged by the implantable energy storage unit and to provide at least one of the first and second hydraulic pump with electrical power.
According to an embodiment, the capacitor is a supercapacitor.
According to an embodiment, at least one of the first and second hydraulic pump comprises an electrical motor (M) for operating the hydraulic pump.
According to an embodiment, wherein the capacitor is further configured to provide electrical power to at least one of: a device for providing electrical stimulation to a tissue portion of the body of the patient. a CPU for encrypting information. a transmitting and/or receiving unit for communication with an external unit. a measurement unit or a sensor. a data collection unit. a solenoid. a piezo-electrical element. a memory metal unit.
According to an embodiment, the capacitor is further configured to provide electrical power to a valve.
According to an embodiment, the capacitor is further configured to provide electrical power to a controller for controlling at least a part of the implantable pumping device.
According to an embodiment, the implantable pumping device further comprises an external energy storage unit configured be arranged outside of the patient's body and configured to provide energy to the implantable energy storage unit. The implantable pumping device further comprises an implantable energy receiver configured to be electrically connected to the implantable energy storage unit and enable charging of the implantable energy storage unit by the external energy storage unit.
According to an embodiment, the implantable pumping device further comprises a temperature sensor for sensing a temperature of the implantable energy storage unit.
According to an embodiment, the implantable pumping device further comprises a temperature sensor for sensing a temperature of the capacitor
According to an embodiment, the sensor is at least one of: a hall effect sensor, a fluxgate sensor, an ultra-sensitive magnetic field sensor or a magneto-resistive sensor.
According to an embodiment, the frequency of the magnetic field generated by the coil is 9-315 kHz.
According to an embodiment, the frequency of the magnetic field generated by the coil is less than or equal to 125 kHz, preferably less than 58 kHz.
According to an embodiment, the controller comprises a receiver unit. The controller and the external control unit are configured to transmit and/or receive data via the receiver unit and the first coil via magnetic induction.
According to an embodiment, the receiver unit comprises a high-sensitivity magnetic field detector.
According to an embodiment, the receiver unit comprises a second coil.
According to an embodiment, the implantable pumping device further comprises comprising an implantable energy storage unit electrically connected to the receiver unit, wherein the implantable energy storage unit is adapted to be charged by the external control unit via the receiver unit.
According to an embodiment, the implantable energy storage unit is configured to be charged via magnetic induction between the first and the second coils.
According to an embodiment, the receiver unit is configured to control the charging of the implantable energy storage unit by controlling a receipt of electrical power from the external control unit at the receiver unit.
According to an embodiment, the internal receiver unit is configured to control the charging of the implantable energy storage unit by controlling a transmission of electrical power from the external control unit to the receiver unit.
According to an embodiment, the implantable pumping device further comprises a sensation generator adapted to generate a sensation detectable by a sense of the patient, the sensation generator being connected to the controller or the external control unit, and being configured to, upon request, generate the sensation when implanted in a patient.
According to an embodiment, the sensation generator is configured to receive the request from the controller or the implantable pumping device.
According to an embodiment, the sensation generator is configured to receive the request from an external device.
According to an embodiment, the sensation generator is configured to create the sensation comprising a plurality of sensation components.
According to an embodiment, the sensation generator (381) is configured to create the sensation or sensation components by at least one of: a vibration of the sensation generator. producing a sound. providing a photonic signal. providing a light signal. providing an electric signal. a heat signal.
According to an embodiment, the sensation generator is adapted to be implanted in the patient.
According to an embodiment, the sensation generator is configured to be worn in contact with the skin of the patient
According to an embodiment, the sensation generator is configured generate the sensation without being in physical contact with the patient.
According to an embodiment, the external control unit comprises a wireless remote control.
According to an embodiment, the wireless remote control comprises an external signal transmitter. The internal receiver is further configured to receive a signal transmitted by the external signal transmitter and to control an operation of the apparatus based on said signal, when the processing unit is in the active state.
According to an embodiment, the signal is selected from the group consisting of: a sound signal, an ultrasound signal, an electromagnetic signal, and infrared signal, a visible light signal, an ultraviolet light signal, a laser signal, a microwave signal, a radio wave signal, an X-ray radiation signal and a gamma radiation signal.
According to an embodiment, the step of inserting an implantable pumping device into the body of the patient comprises inserting an implantable pumping device comprising a first, second and third luminary organ contacting element. The first luminary organ contacting element comprises a first operable hydraulic constriction element configured to be inflated to constrict the urinary bladder for restricting the flow of fluid therethrough. The second luminary organ contacting element comprises a second operable hydraulic constriction element configured to be inflated to assist in releasing the constriction of the urinary bladder for restoring the flow of fluid therethrough. The third luminary organ contacting element comprises at least one cushioning element configured to contact the urinary bladder.
According to an embodiment, the step of inserting an implantable pumping device into the body of the patient comprises inserting an implantable pumping device comprising a first operable hydraulic constriction element configured to be inflated to constrict the urinary bladder for restricting the flow of fluid therethrough. The implantable pumping device further comprises a second operable hydraulic constriction element configured to be inflated to constrict the urinary bladder for restricting the flow of fluid therethrough and for evacuating urine from the urinary bladder. The implantable pumping device further comprises an interconnecting fluid conduit fluidly connecting the first operable hydraulic constriction element to the second operable hydraulic constriction element. The first operable hydraulic constriction element is configured to be placed at a first portion of the urinary bladder for constricting the first portion of the urinary bladder for restricting the flow of fluid therethrough. The second operable hydraulic constriction element is configured to be placed at a second portion of the luminary organ, downstream the first portion, for constricting the second portion of the urinary bladder for restricting the flow of fluid therethrough and for evacuating urine from the urinary bladder. The interconnecting fluid conduit is configured to conduct fluid from the first operable hydraulic constriction element to the second operable hydraulic constriction element when the pressure increases in the first operable hydraulic constriction element, such that second operable hydraulic constriction element constricts the second portion of the urinary bladder further.
According to an embodiment, the step of inserting an implantable pumping device into the body of the patient comprises inserting an implantable pumping device comprising a first operable hydraulic constriction element configured to be inflated and thereby expand in a first direction towards the urinary bladder to constrict a first portion of the urinary bladder for restricting the flow of fluid therethrough. The implantable pumping device further comprises a supporting operable hydraulic constriction element configured to be inflated and thereby expand in the first direction towards the urinary bladder to support the first operable hydraulic constriction element in constricting the first portion of the urinary bladder for restricting the flow of fluid therethrough.
According to an embodiment, the step of inserting an implantable pumping device into the body of the patient comprises inserting an implantable pumping device comprising at least two implantable constriction devices each comprising a first operable hydraulic constriction element configured to be inflated to exert a pressure on the urinary bladder in a first direction to constrict a first portion of the urinary bladder for restricting the flow of fluid therethrough. The implantable constriction devices further comprise a second operable hydraulic constriction element configured to be inflated to exert a pressure on the urinary bladder in a second direction to constrict the first portion of the urinary bladder for restricting the flow of fluid therethrough. The implantable constriction devices further comprise a first hydraulic system in fluid connection with the first operable hydraulic constriction element, and a second hydraulic system in fluid connection with the second operable hydraulic constriction element. The first and second operable hydraulic constriction elements are adjustable independently from each other.
According to an embodiment, the step of inserting an implantable pumping device into the body of the patient comprises inserting an implantable pumping device comprising at least two implantable constriction devices. Each implantable constriction device comprises an operable hydraulic constriction element configured to be inflated to exert a pressure on the urinary bladder. Each implantable constriction device further comprises a hydraulic reservoir for holding a hydraulic fluid. Each implantable constriction device further comprises a hydraulic pump for pumping fluid from the hydraulic reservoir to the operable hydraulic constriction element. Each implantable constriction device further comprises a first fluid conduit creating a fluid connection between the hydraulic reservoir and the hydraulic pump. Each implantable constriction device further comprises a second fluid conduit creating a fluid connection between the hydraulic pump and the operable hydraulic constriction element. Each implantable constriction device further comprises an injection port for injecting and removing hydraulic fluid from the implantable constriction device when implanted. Each implantable constriction device further comprises a third fluid conduit creating a fluid connection between the injection port and at least one of the second fluid conduit and the operable hydraulic constriction element, such that hydraulic fluid can be removed from the operable hydraulic constriction element through the injection port.
According to an embodiment, the step of inserting an implantable pumping device into the body of the patient inserting an implantable pumping device comprising at least two implantable constriction devices. Each implantable constriction device comprises an operable hydraulic constriction element configured to be inflated to exert a pressure on the urinary bladder. Each implantable constriction device further comprises a hydraulic reservoir for holding a hydraulic fluid. Each implantable constriction device further comprises a hydraulic pump for pumping fluid from the hydraulic reservoir to the operable hydraulic constriction element. Each implantable constriction device further comprises a first fluid conduit creating a fluid connection between the hydraulic reservoir and the hydraulic pump. Each implantable constriction device further comprises an electrode arrangement configured to be arranged between the implantable constriction device and the urinary bladder and to engage and electrically stimulate muscle tissue of the urinary bladder to exercise the muscle tissue to improve the conditions for long term implantation of the implantable constriction device.
According to an embodiment, the step of inserting an implantable pumping device into the body of the patient comprises inserting an implantable pumping device comprising at least two implantable constriction devices. Each implantable constriction device comprises a first operable hydraulic constriction element configured to be inflated to exert a pressure on the urinary bladder. Each implantable constriction device further comprises a second operable hydraulic constriction element configured to be inflated to exert a pressure on the urinary bladder. Each implantable constriction device further comprises a first hydraulic pump for pumping fluid to the operable hydraulic constriction element. Each implantable constriction device further comprises a second hydraulic pump for pumping fluid to the operable hydraulic constriction element. Each implantable constriction device further comprises a motor. The motor is mechanically connected to the first and second hydraulic pump for propelling the first and second hydraulic pump.
According to an embodiment, the step of inserting an implantable pumping device into the body of the patient comprises inserting an implantable pumping device comprising at least two implantable constriction devices. Each implantable constriction device comprises an operable hydraulic constriction element configured to be inflated to exert a pressure on the urinary bladder. Each implantable constriction device further comprises a pressure sensor configured to sense the pressure in the operable hydraulic constriction element. Each implantable constriction device further comprises a hydraulic pump for pumping a hydraulic fluid to the operable hydraulic constriction element. Each implantable constriction device further comprises a controller configured to receive pressure sensor input from the pressure sensor and control the hydraulic pump on the basis of the received pressure sensor input. The pressure sensor comprises a diaphragm, and wherein the diaphragm is in fluid connection with the hydraulic fluid in the operable hydraulic constriction element. The diaphragm is further connected to a pressure sensing element of the pressure sensor, such that the pressure sensing element is separated from the hydraulic fluid in the operable hydraulic constriction element by the diaphragm
According to an embodiment, the step of inserting an implantable pumping device into the body of the patient comprises inserting an implantable pumping device comprising at least two implantable constriction devices. Each implantable constriction device comprises an operable hydraulic constriction element configured to be inflated to exert a pressure on the urinary bladder. Each implantable constriction device further comprises a hydraulic pump for pumping a hydraulic fluid to the operable hydraulic constriction element. The hydraulic pump comprises a compressible reservoir configured to hold a hydraulic fluid to be moved to the operable hydraulic constriction element. Each implantable constriction device further comprises a motor comprising a shaft. The motor is configured to generate force in a radial direction by rotation of the shaft. Each implantable constriction device further comprises a transmission configured to transfer the force in the radial direction to a force substantially in an axial direction of the shaft for compressing the compressible reservoir. Each implantable constriction device further comprises at least one bearing for the shaft. The bearing is configured to withhold at least half of the force in the axial direction, for reducing the axial load on at least one of the motor and a gear system, caused by the compression of the reservoir.
According to an embodiment, the step of inserting an implantable pumping device into the body of the patient comprises inserting an implantable pumping device comprising at least two implantable constriction devices. Each implantable constriction device comprises at least one implantable operable hydraulic constriction element. Each implantable operable hydraulic constriction element comprises a contacting wall portion configured to engage the urinary bladder for exerting force thereon. Each implantable operable hydraulic constriction element further comprises a withholding wall portion configured to be connected to a withholding structure for withholding the force exerted on the urinary bladder, such that the urinary bladder is constricted. Each implantable operable hydraulic constriction element further comprises a connecting wall portion, connecting the contacting wall portion to the withholding wall portion. A first portion of the connecting wall portion is connected to the contacting wall portion. A second portion of the connecting wall portion is connected to the withholding wall portion. The first portion of the connecting wall portion is more resilient than the second portion of the connecting wall portion.
According to an embodiment, the step of inserting an implantable pumping device into the body of the patient comprises inserting an implantable pumping device comprising at least two implantable constriction devices. Each implantable constriction device comprises an operable hydraulic constriction element configured to be inflated to exert a pressure on the urinary bladder. Each implantable constriction device further comprises a hydraulic pump for pumping a hydraulic fluid to the operable hydraulic constriction element. Each implantable constriction device comprises an implantable energy storage unit. Each implantable constriction device comprises a capacitor connected to the implantable energy storage unit and connected to the hydraulic pump. The capacitor is configured to be charged by the implantable energy storage unit and to provide the hydraulic pump with electrical power.
According to an embodiment, the step of inserting an implantable pumping device into the body of the patient comprises inserting an implantable pumping device comprising at least two implantable constriction devices. Each implantable constriction device comprises an operable hydraulic constriction element configured to be inflated to exert a pressure on the urinary bladder. Each implantable constriction device comprises a hydraulic pump for pumping a hydraulic fluid to the operable hydraulic constriction element. Each implantable constriction device comprises a controller configured to control the hydraulic pump. The controller comprises a sensor adapted to detect a magnetic field and a processing unit having a sleep mode and an active mode. Each implantable constriction device comprises an external control unit adapted to be arranged outside of the patient's body, the external control unit comprising a first coil adapted to create a magnetic field detectable by the internal sensor. The controller is further configured to, in response to a detected magnetic field exceeding a predetermined value, setting the processing unit in an active mode.
According to an embodiment, the step of placing the implantable pumping device in connection with the urinary bladder comprises placing the implantable pumping device around the urinary bladder of the patient.
According to an embodiment, the step of placing the implantable pumping device in connection with the urinary bladder comprises closing a locking or fixation device of the implantable pumping device around the urinary bladder to fixate the implantable pumping device to the urinary bladder of the patient.
According to an embodiment, the step of placing the implantable pumping device in connection with the urinary bladder comprises securing the implantable pumping device by means of at least one of sutures, staples and tissue growth promoting structure.
According to an embodiment, the step of inserting an implantable pumping device into the body of the patient comprises inserting an implantable controller into the body of the patient and fixating the implantable controller to tissue or bone in the body of the patient.
According to an embodiment, the step of inserting an implantable pumping device into the body of the patient comprises inserting an operation device comprising at least one of: an implantable hydraulic pump and an implantable valve and fixating the implantable operation device to tissue or bone in the body of the patient.
According to an embodiment, the method further comprises the step of implanting and fixating at least one injection port in fluid connection with the operation device.
According to an embodiment, the step of fixating the at least one injection port comprises the step of fixating the injection port subcutaneously.
According to an embodiment, the method further comprises the step of calibrating the fluid level in the implantable pumping device.
According to an embodiment, the method further comprises calibrating at least one of: the pressure exerted by the implantable pumping device on the urinary bladder. the time during which implantable pumping device is to remain closed after activation, the speed with which the implantable pumping device should constrict the urinary bladder. the pressure exerted on the urinary bladder relative to the blood pressure of the patient. the pressure exerted on the urinary bladder by the implantable pumping device by means of a pressure sensitive catheter. the electrical stimulation of the tissue of the urinary bladder.
According to an embodiment, the method further comprises testing at least one of: a fully open catheter mode. a feedback function by providing sensory feedback to the patient. a post-operative mode for enabling healing. a post-operative mode for enabling growth of fibrotic tissue. electrical stimulation of the tissue of the urinary bladder.
According to an embodiment, the method further comprises placing a second portion of an implantable energized medical device between a peritoneum and a layer of muscular tissue of the abdominal wall. The method further comprises placing a first portion of the implantable energized medical device between the skin of the patient and a layer of muscular tissue of the abdominal wall, wherein the first and second portions are configured to be connected by a connecting portion extending through at least one layer of muscular tissue of the abdominal wall. The method further comprises placing a transferring member, configured to transfer at least one of energy and force from the second portion to the implantable pumping device, at least partially between a peritoneum and a layer of muscular tissue of the abdominal wall, such that at least ⅓ of the length of the transferring member is placed on the outside of the peritoneum.
According to an embodiment, the step of measuring the pressure in the first and/or second implantable hydraulic constriction element, when substantially no pressure is exerted on the urinary bladder, further comprises comparing the measured pressure with the atmospheric pressure.
According to an embodiment, the step of comparing the measured pressure with the atmospheric pressure comprises measuring the atmospheric pressure using a pressure sensor connected to a signal transmitter located outside the body of the patient.
According to an embodiment, the step of increasing the pressure in the first and second implantable hydraulic constriction element to a defined level, comprises inflating the first and/or second implantable hydraulic constriction element to a defined cross-sectional distance.
According to an embodiment, the method further comprises measuring the pressure in the first and/or second implantable hydraulic constriction element when the pressure in the implantable hydraulic constriction element has been increased.
According to an embodiment, steps of: measuring the pressure in the first and/or second implantable hydraulic constriction element, when substantially no pressure is exerted on the urinary bladder, and measuring the pressure in the first and/or second implantable hydraulic constriction element when the pressure in the implantable hydraulic constriction element has been increased, are performed using the same pressure sensor.
According to an embodiment, the method further comprises the step of creating, in the controller, an absolute pressure by subtracting the pressure in the first and/or second implantable hydraulic constriction element, when substantially no pressure is exerted on the urinary bladder, from the pressure in the hydraulic constriction element, when the pressure in the implantable hydraulic constriction element has been increased. The step of controlling the operation device comprises controlling the operation device on the basis of the absolute pressure.
According to an embodiment, the computing unit is further configured to compare the measured pressure with the atmospheric pressure.
According to an embodiment, the controller is further configured to receive a pressure signal from a pressure sensor located outside of the body of the patient and compare the measured pressure with a pressure received in the pressure signal.
According to an embodiment, wherein the controller is configured to increase the pressure in the first and/or second implantable hydraulic constriction element on the basis of the measured pressure.
According to an embodiment, the controller is configured to increase the pressure in the first and/or second implantable hydraulic constriction element to a defined cross-sectional distance.
According to an embodiment, the coating comprises at least one layer of a biomaterial.
According to an embodiment, the biomaterial comprises at least one drug or substance with antithrombotic and/or antibacterial and/or antiplatelet characteristics.
According to an embodiment, the biomaterial is fibrin-based.
According to an embodiment, the implantable pumping device further comprises a second coating arranged on the first coating.
According to an embodiment, the second coating is a different biomaterial than said first coating.
According to an embodiment, the first coating comprises a layer of perfluorocarbon chemically attached to the surface. The second coating comprises a liquid perfluorocarbon layer.
According to an embodiment, the coating comprises a drug encapsulated in a porous material.
According to an embodiment, the surface comprises a metal.
According to an embodiment, the metal comprises at least one of the following, titanium, cobalt, nickel, copper, zinc, zirconium, molybdenum, tin or lead.
According to an embodiment, the surface comprises a micropattern.
According to an embodiment, the micropattern is etched into the surface prior to insertion into the body.
According to an embodiment, the implantable pumping device further comprises a layer of a biomaterial coated on the micropattern.
According to an embodiment, the connecting portion comprises a flange comprising the fourth cross-sectional area, such that the flange is prevented from travelling through the hole in the tissue portion in a direction perpendicular to the first, second and third planes.
According to an embodiment, the flange protrudes in a direction parallel to the first, second, third and fourth planes, and perpendicular to a central extension of the connecting portion.
According to an embodiment, the flange comprises the third surface configured to engage the first tissue surface of the first side of the tissue portion.
According to an embodiment, the connecting portion comprises at least one protruding element comprising the fourth cross-sectional area, such that the at least one protruding element is prevented from travelling through the hole in the tissue portion, such that the second portion and the connecting portion can be held in position by the tissue portion of the patient also when the first portion is disconnected from the connecting portion.
According to an embodiment, the at least one protruding element protrudes in a direction parallel to the first, second, third and fourth planes, and perpendicular to a central extension of the connecting portion.
According to an embodiment, the at least one protruding element comprises the third surface configured to engage the first tissue surface of the first side of the tissue portion.
According to an embodiment, the connecting portion comprises at least two protruding elements comprising the fourth cross-sectional area.
According to an embodiment, the at least two protruding elements are symmetrically arranged about a central axis of the connecting portion.
According to an embodiment, the at least two protruding elements are asymmetrically arranged about a central axis of the connecting portion.
According to an embodiment, at least one of the first, second and third surfaces comprises at least one of ribs, barbs, hooks, a friction enhancing surface treatment, and a friction enhancing material, to facilitate the implantable energized medical device being held in position by the tissue portion.
According to an embodiment, the connecting portion comprises a hollow portion.
According to an embodiment, the hollow portion provides a passage between the first and second portions.
According to an embodiment, the first portion is detachably connected to the connecting portion by at least one of a mechanical connection and a magnetic connection.
According to an embodiment, the first portion is detachably connected to the connecting portion by at least one of threads and corresponding grooves, a screw, a self-locking element, a twist and lock fitting, and a spring-loaded locking mechanism.
According to an embodiment, the at least one protruding element has a height in a direction perpendicular to the fourth plane being less than a height of the first portion in said direction.
According to an embodiment, the at least one protruding element has a height in said direction perpendicular to the fourth plane being less than half of said height of the first portion in said direction.
According to an embodiment, the at least one protruding element has a height in said direction perpendicular to the fourth plane being less than a quarter of said height of the first portion in said direction.
According to an embodiment, the at least one protruding element has a height in said direction perpendicular to the fourth plane being less than a tenth of said height of the first portion in said direction.
According to an embodiment, the at least one protruding element has a diameter in the fourth plane being one of: less than a diameter of the first portion in the first plane, equal to a diameter of the first portion in the first plane, and larger than a diameter of the first portion in the first plane.
According to an embodiment, the at least one protruding element has a cross-sectional area in the fourth plane being one of: less than a cross-sectional area of the first portion in the first plane, equal to a cross-sectional area of the first portion in the first plane, and larger than a cross-sectional area of the first portion in the first plane.
According to an embodiment, the at least one protruding element has a height in said direction perpendicular to the fourth plane being less than half of a height of the connecting portion in said direction.
According to an embodiment, the at least one protruding element has a height in said direction perpendicular to the fourth plane being less than a quarter of said height of the connecting portion in said direction.
According to an embodiment, the at least one protruding element has a height in said direction perpendicular to the fourth plane being less than a tenth of said height of the connecting portion in said direction.
According to an embodiment, the first portion comprises a first wireless energy receiver configured to receive energy transmitted wirelessly from an external wireless energy transmitter.
According to an embodiment, the first portion comprises an internal wireless energy transmitter.
According to an embodiment, the second portion comprises a second wireless energy receiver.
According to an embodiment, the first portion comprises a first energy storage unit.
According to an embodiment, the second portion comprises a second energy storage unit.
According to an embodiment, at least one of the first and second energy storage unit is a solid-state battery.
According to an embodiment, the solid-state battery is a thionyl-chloride battery.
According to an embodiment, the first wireless energy receiver is configured to receive energy transmitted wirelessly by the external wireless energy transmitter, and store the received energy in the first energy storage unit. The internal wireless energy transmitter is configured to wirelessly transmit energy stored in the first energy storage unit to the second wireless energy receiver. The second wireless energy receiver is configured to receive energy transmitted wirelessly by the internal wireless energy transmitter and store the received energy in the second energy storage unit.
According to an embodiment, the first portion comprises a first controller comprising at least one processing unit.
According to an embodiment, the second portion comprises a second controller comprising at least one processing unit.
According to an embodiment, at least one of the first and second controller is connected to a wireless transceiver for communicating wirelessly with an external device.
According to an embodiment, the first controller is connected to a first wireless communication receiver in the first portion for receiving wireless communication from an external device. The first controller is connected to a first wireless communication transmitter in the first portion for transmitting wireless communication to a second wireless communication receiver in the second portion.
According to an embodiment, the second controller is connected to the second wireless communication receiver for receiving wireless communication from the first portion.
According to an embodiment, the first wireless energy receiver comprises a first coil and the internal wireless energy transmitter comprises a second coil.
According to an embodiment, the first portion comprises a combined coil, wherein the combined coil is configured to receive energy wirelessly from an external wireless energy transmitter, and transmit energy wirelessly to the second wireless receiver of the second portion.
According to an embodiment, at least one of the coils are embedded in a ceramic material.
According to an embodiment, the medical device further comprises a housing configured to enclose at least the first portion. A first portion of the housing is made from titanium and a second portion of the housing is made from a ceramic material.
According to an embodiment, the portion of the housing made from a ceramic material comprises at least one coil embedded in the ceramic material.
According to an embodiment, the medical device further comprises a housing configured to enclose at least the second portion. A first portion of the housing is made from titanium and a second portion of the housing is made from a ceramic material.
According to an embodiment, the medical device further comprises at least one sensor for providing input to at least one of the first and second controller.
According to an embodiment, the sensor is a sensor configured to sense a physical parameter of the implantable energized medical device.
According to an embodiment, the sensor is a sensor configured to sense at least one of: a temperature of the implantable energized medical device or of a body engaging portion, a parameter related to the power consumption of the implantable energized medical device or of a body engaging portion, a parameter related to a status of at least one of the first and second energy storage unit, a parameter related to the wireless transfer of energy from a source external to the body of the patient, and a hydraulic pressure.
According to an embodiment, the sensor is a sensor configured to sense a physiological parameter of the patient.
According to an embodiment, the sensor is a sensor configured to sense at least one of: a parameter related to the patient swallowing, a local temperature, a systemic temperature, blood saturation, blood oxygenation, blood pressure, a parameter related to an ischemia marker, and pH.
According to an embodiment, the sensor configured to sense a parameter related to the patient swallowing comprises at least one of: a motility sensor, a sonic sensor, an optical sensor, and a strain sensor.
According to an embodiment, the sensor configured to sense pH is configured to sense the acidity in the stomach.
According to an embodiment, the controller is configured to transmit information based on sensor input to a device external to the body of the patient.
According to an embodiment, the second portion comprises at least a portion of an operation device for operating an implantable body engaging portion.
According to an embodiment, the second portion comprises at least one electrical motor.
According to an embodiment, the second portion comprises a transmission configured to reduce the velocity and increase the force of the movement generated by the electrical motor.
According to an embodiment, the transmission is configured to transfer a week force with a high velocity into a stronger force with lower velocity.
According to an embodiment, the transmission is configured to transfer a rotating force into a linear force.
According to an embodiment, the transmission comprises a gear system.
According to an embodiment, the second portion comprises a magnetic coupling for transferring mechanical work from the electrical motor through one of: a barrier separating a first chamber of the second portion from a second chamber of the second portion, a housing enclosing at least the second portion.
According to an embodiment, the second portion comprises at least one hydraulic pump.
According to an embodiment, the hydraulic pump comprises a pump comprising at least one compressible hydraulic reservoir.
According to an embodiment, the medical device further comprises a capacitor connected to at least one of the first and second energy storage unit and connected to the electrical motor. The capacitor is configured to: be charged by at least one of the first and second energy storage units, and provide the electrical motor with electrical power.
According to an embodiment, at least one of the first and second portion comprises a sensation generator adapted to generate a sensation detectable by a sense of the patient.
According to an embodiment, the second portion comprises a force transferring element configured to mechanically transfer force from the second portion to an implanted body engaging portion.
According to an embodiment, the second portion comprises a force transferring element configured to hydraulically transfer force from the second portion to an implanted body engaging portion.
According to an embodiment, the second portion comprises at least one lead for transferring electrical energy and/or information from the second portion to an implanted body engaging portion.
According to an embodiment, the first portion comprises an injection port for injecting fluid into the first portion.
According to an embodiment, the connecting portion comprises a conduit for transferring a fluid from the first portion to the second portion.
According to an embodiment, the conduit is arranged to extend through the hollow portion of the connecting portion.
According to an embodiment, the second portion comprises a first and a second chamber separated from each other. The first chamber comprises a first liquid and the second chamber comprises a second liquid. The second liquid is a hydraulic liquid configured to transfer force to an implantable element configured to exert force on the body portion of the patient.
According to an embodiment, a wall portion of the first chamber is resilient to allow an expansion of the first chamber.
According to an embodiment, the second portion comprises a first hydraulic system in fluid connection with a first hydraulically operable implantable element configured to exert force on the body portion of the patient, and a second hydraulic system in fluid connection with a second hydraulically operable implantable element configured to exert force on the body portion of the patient, wherein the first and second hydraulically operable implantable elements are adjustable independently from each other.
According to an embodiment, the first hydraulic system comprises a first hydraulic pump and the second hydraulic systems comprises a second hydraulic pump.
According to an embodiment, each of the first and second hydraulic systems comprises a reservoir for holding hydraulic fluid
According to an embodiment, the medical device further comprises a first pressure sensor configured to sense a pressure in the first hydraulic system, and a second pressure sensor configured to sense a pressure in the second hydraulic system
According to an embodiment, the first surface is configured to engage the first tissue surface of the first side of the tissue portion.
According to an embodiment, the first, second and third planes are parallel to a major extension plane of the tissue.
According to an embodiment, the fourth plane is parallel to a major extension plane of the tissue.
According to an embodiment, the transferring member is configured to transfer mechanical force from the second portion to the body engaging portion.
According to an embodiment, the transferring member is configured to transfer hydraulic force from the second portion to the body engaging portion.
According to an embodiment, the transferring member is configured to transfer electrical energy force from the second portion to the body engaging portion.
According to an embodiment, the transferring member is configured to transfer data between the second portion and the body engaging portion.
According to an embodiment, the step of placing the transferring member comprises placing the transferring member at least partially between the peritoneum and the layer of muscular tissue of the abdominal wall, such that at least ½ of the length of the transferring member is placed on the outside of the peritoneum of the patient.
According to an embodiment, the step of placing the transferring member comprises placing the transferring member at least partially between the peritoneum and the layer of muscular tissue of the abdominal wall, such that at least ⅔ of the length of the transferring member is placed on the outside of the peritoneum of the patient.
According to an embodiment, the step of placing the transferring member comprises placing the transferring member entirely outside of the peritoneum of the patient.
According to an embodiment, the step of placing the transferring member comprises placing the transferring member such that it extends from the second portion to an area between the rib cage and the peritoneum of the patient, outside of the peritoneum.
According to an embodiment, the step of placing the transferring member comprises placing the transferring member such that it extends from the second portion to the subperitoneal space, outside of the peritoneum.
According to an embodiment, the step of placing the transferring member comprises placing the transferring member such that it extends from the second portion to the urinary bladder, outside of the peritoneum.
According to an embodiment, the step of placing the transferring member comprises placing the transferring member such that it extends from the second portion to the urethra, outside of the peritoneum.
According to an embodiment, the step of placing the second portion of the implantable energized medical device between the peritoneum and the layer of muscular tissue of the abdominal wall comprises placing the second portion between a first and second layer of muscular tissue of the abdominal wall.
According to an embodiment, wherein the step of placing the second portion comprises placing a second portion comprising an electrical motor.
According to an embodiment, the step of placing the second portion comprises placing a second portion comprising a hydraulic pump.
According to an embodiment, the step of placing the second portion comprises placing a second portion comprising an energy storage unit.
According to an embodiment, the step of placing the second portion comprises placing a second portion comprising a receiver for receiving at least one of: energy and communication, wirelessly.
According to an embodiment, the step of placing the first portion comprises placing a first portion comprising a transmitter for transmitting at least one of: energy and communication, wirelessly.
According to an embodiment, the step of placing the second portion comprises placing a second portion comprising a controller involved in the control of the powered medical device.
According to an embodiment, the second portion is elongated and has a length axis extending substantially in the direction of the elongation of the second portion. The step of placing the second portion comprises placing the second portion such that the length axis is substantially parallel with the cranial-caudal axis of the patient.
According to an embodiment, the second portion is elongated and has a length axis extending substantially in the direction of the elongation of the second portion. The step of placing the second portion comprises placing the second portion such that the length axis is substantially perpendicular with the cranial-caudal axis of the patient.
According to an embodiment, the second portion is elongated and has a length axis extending substantially in the direction of the elongation of the second portion. The step of placing the second portion comprises entering a hole in a layer of muscular tissue of the stomach wall in the direction of the length axis of the second portion and pivoting or angling the second portion after the hole has been entered.
According to an embodiment, the step of placing the first portion of the implantable energized medical device between the skin of the patient and a layer of muscular tissue of the abdominal wall comprises placing the first portion in the subcutaneous tissue.
According to an embodiment, the step of placing the first portion of the implantable energized medical device between the skin of the patient and a layer of muscular tissue of the abdominal wall comprises placing the first portion between a first and second layer of muscular tissue of the abdominal wall.
According to an embodiment, the step of placing the first portion comprises placing a first portion comprising an energy storage unit.
According to an embodiment, the step of placing the first portion comprises placing a first portion comprising a receiver for receiving at least one of: energy and communication, wirelessly.
According to an embodiment, the step of placing the first portion comprises placing a first portion comprising a transmitter for transmitting at least one of: energy and communication, wirelessly.
According to an embodiment, the step of placing the first portion comprises placing a first portion comprising a controller involved in the control of the powered medical device.
According to an embodiment, the first portion is elongated and has a length axis extending substantially in the direction of the elongation of the first portion. The step of placing the first portion comprises placing the first portion such that the length axis is substantially parallel with the cranial-caudal axis of the patient.
According to an embodiment, the first portion is elongated and has a length axis extending substantially in the direction of the elongation of the first portion. The step of placing the first portion comprises placing the first portion such that the length axis is substantially perpendicular with the cranial-caudal axis of the patient.
According to an embodiment, the first portion is elongated and has a first portion length axis extending substantially in the direction of the elongation of the first portion. The second portion is elongated and has a second portion length axis extending substantially in the direction of the elongation of the second portion. The step of placing the first and second portions comprises placing the first and second portions such that the first portion length axis and the second portion length axis are placed at an angle in relation to each other exceeding 30°.
According to an embodiment, the step of placing the first and second portions comprises placing the first and second portions such that the first portion length axis and the second portion length axis are placed at an angle in relation to each other exceeding 45°.
According to an embodiment, the method of implanting powered medical device further comprises the step of placing the connecting portion through at least one layer of muscular tissue of the abdominal wall.
According to an embodiment, the first portion, the second portion and the connecting portion are portions of a single unit.
According to an embodiment, the method of implanting powered medical device further comprises the step of connecting the first portion to the connecting portion, in situ.
According to an embodiment, the method of implanting powered medical device further comprises the step of connecting the second portion to the connecting portion, in situ.
According to an embodiment, the method of implanting powered medical device further comprises the step of connecting the transferring member to the first portion.
According to an embodiment, the method of implanting powered medical device further comprises the step of connecting the transferring member to the body engaging portion.
According to an embodiment, the body engaging portion comprises a medical device for stretching the stomach wall such that a sensation of satiety is created.
According to an embodiment, the body engaging portion comprises a constriction device configured to constrict a luminary organ of a patient.
According to an embodiment, the body engaging portion comprises an implantable constriction device.
According to an embodiment, the implantable constriction device comprises an implantable constriction device for constricting a luminary organ of the patient.
According to an embodiment, the body engaging portion comprises an implantable element for actively emptying the urinary bladder of the patient.
According to an embodiment, the implantable element for actively emptying the urinary bladder of the patient is configured to empty the bladder of the patient by compressing the urinary bladder from the outside thereof.
According to an embodiment, the body engaging comprises an element for electrically stimulating a tissue portion of a patient.
According to one embodiment, the first wireless transceiver comprises an UWB transceiver.
According to one embodiment, the first wireless transceiver is configured for transcutaneous energy transfer for at least one of powering an energy consuming component of the implantable medical device and charging an implantable energy storage unit.
According to one embodiment, the second network protocol is a standard network protocol. The standard network protocol may be one from the list of: Radio Frequency type protocol, RFID type protocol, WLAN type protocol, Bluetooth type protocol, BLE type protocol, NFC type protocol, 3G/4G/5G type protocol, and GSM type protocol.
According to one embodiment, the second wireless transceiver comprises a Bluetooth transceiver.
According to one embodiment, the external device is further configured to communicate with a second external device using said at least one wireless transceiver.
According to one embodiment, the external device is configured for determining a distance between the external device and the implantable medical device by determining the RSSI.
According to one embodiment, a communication range of the first network protocol is less than a communication range of the second network protocol.
According to one embodiment, a frequency band of the first network protocol differs from a frequency band of the second network protocol.
According to one embodiment, the external device is configured to authenticate the implantable medical device if the determined distance between the external device and the implantable medical device is less than a predetermined threshold value.
According to one embodiment, the external device is configured to allow the transfer of data between the external device and the implantable medical device after the implantable medical device has been authenticated.
According to one embodiment, the external device is one from the list of: a wearable external device, and a handset.
According to one embodiment, the first wireless transceiver comprises an UWB transceiver.
According to one embodiment, the first wireless transceiver is configured for transcutaneous energy transfer for at least one of: powering an energy consuming component of the implantable medical device, and charging an implantable energy storage unit.
According to one embodiment, the second network protocol is a standard network protocol, such as selected from the list of Radio Frequency type protocol, RFID type protocol, WLAN type protocol, Bluetooth type protocol, BLE type protocol, NFC type protocol, 3G/4G/5G type protocol, and GSM type protocol.
According to one embodiment, the second wireless transceiver comprises a Bluetooth transceiver.
According to one embodiment, the implantable medical device is further configured to communicate with a second external device using said at least one wireless transceiver.
According to one embodiment, the implantable medical device is configured for determining a distance between the external device and the implantable medical device by determining the RSSI.
According to one embodiment, a communication range of the first network protocol is less than a communication range of the second network protocol.
According to one embodiment, a frequency band of the first network protocol differs from a frequency band of the second network protocol.
According to one embodiment, the implantable medical device is configured to authenticate the external device if the determined distance between the external device and the implantable medical device is less than a predetermined threshold value.
According to one embodiment, the implantable medical device is configured to allow the transfer of data between the implantable medical device and the external device after the external device has been authenticated.
According to one embodiment, the implantable medical device comprises at least one of: an external heart compression device, an apparatus assisting the pump function of a heart of the patient, an apparatus assisting the pump function comprising a turbine bump placed within a patient's blood vessel for assisting the pump function of the heart, an operable artificial heart valve, an operable artificial heart valve for increasing the blood flow to the coronary arteries, an implantable drug delivery device, an implantable drug delivery device for injecting directly into a blood vessel and change the position of the injection site, all from within the patient's body, an implantable drug delivery device for injecting potency enhancing drugs into an erectile tissue of the patient, a hydraulic, mechanic, and/or electric constriction implant, an operable volume filling device, an operable gastric band, an operable implant for stretching the stomach wall of the patient for creating satiety, an implant configured to sense the frequency of the patient ingesting food, an operable cosmetic implant, an operable cosmetic implant for adjust the shape and/or size in the breast region of a patient, an implant controlling medical device for the emptying of a urinary bladder, an implant hindering urinary leakage, an implant hindering anal incontinence, an implant controlling the emptying of fecal matter, an implant monitoring an aneurysm, an implant for hindering the expansion of an aneurysm, an implant lubricating a joint, an implant for affecting the blood flow to an erectile tissue of the patient, an implant for simulating the engorgement of an erectile tissue, an implant with a reservoir for holding bodily fluids, an implant storing and/or emptying a bodily reservoir or a surgically created reservoir, an implant communicating with a database outside the body, an implant able to be programmed from outside the body, an implant able to be programmed from outside the body with a wireless signal, an implant treating impotence, an implant controlling the flow of eggs in the uterine tube, an implant controlling the flow of sperms in the uterine tube, an implant controlling the flow of sperms in the vas deferens, an implant for hindering the transportation of the sperm in the vas deferens, an implant treating osteoarthritis, an implant performing a test of parameters inside the body, an implant controlling specific treatment parameters from inside the body, an implant controlling bodily parameters from inside the body, an implant controlling the blood pressure, an implant controlling the blood pressure by affecting the dilatation of the renal artery, an implant controlling a drug treatment parameter, an implant controlling a parameter in the blood, an implant for adjusting or replacing any bone part of a body of the patient, an implant replacing an organ of the patient or part of an organ of the patient or the function thereof, a vascular treatment device, an implant adapted to move fluid inside the body of the patient, an implant configured to sense a parameter related to the patient swallowing, an implant configured to exercise a muscle with electrical or mechanical stimulation, an implant configured for emptying an intestine portion on command, an operable implant configured to be invaginated in the stomach of the patient to reduce the volume of the stomach substantially more than the volume of the device, an implant configured for emptying the urinary bladder from within the patient's body by compressing the bladder, an implant configured for draining fluid from within the patient's body, an implant configured for the active lubrication of a joint with an added lubrication fluid, an implant configured for removing clots and particles from the patient's blood stream, an implant configured for elongating or straightening a bone in the patient, to reduce scoliosis, a device to stimulate the brain for a several position to a focused point, an artificial stomach replacing the function of the natural stomach, an implant configured for adjusting the position of a female's urinary tract or bladder neck, an implant configured for stimulating the ampulla vas deference and creating temporary constriction.
According to one embodiment, the system comprises a master private key device configured to allow issuance of a new private key device, wherein the HCP or HCP admin have such master private key device adapted to able to replace and pair a new patient private key device or HCP private key device into the system, through the HCP EID external device.
According to one embodiment, the patient remote external device and the patient EID external device are an integrated unit.
According to one embodiment, the HCP dedicated device and the HCP EID external device are an integrated unit.
According to one embodiment, the system comprises a measurement device or sensor adapted to deliver a measurement to at least one of the DDI, patent EID external device and a patient display device.
According to one embodiment, the system comprises a food sensor, adapted to measure at least if the patient swallows solid food or is drinking fluid, wherein said food sensor is connected to the control unit of a medical device to cause an action to stretch the stomach after a determined amount of food intake.
According to one embodiment, the wireless communication unit comprises a wireless transceiver for wireless transmission of control commands to the implantable medical device, and wireless transmission of the control interface as the remote display portal to the patient display device.
According to one embodiment, the wireless communication unit comprises a first wireless transceiver for wireless transmission of control commands to the implantable medical device, and a second wireless transceiver for wireless transmission of the control interface to the patient display device.
According to one embodiment, the wireless communication unit is configured for wireless communication with the patient display device using a standard network protocol.
According to one embodiment, the wireless communication unit is configured for wireless communication with the implantable medical device using a proprietary network protocol.
According to one embodiment, the wireless communication unit comprises a Bluetooth transceiver.
According to one embodiment, at least one of the first and second wireless transceiver comprises a Bluetooth transceiver.
According to one embodiment, the wireless communication unit comprises a UWB transceiver.
According to one embodiment, at least one of the first and second wireless transceiver comprises a UWB transceiver.
According to one embodiment, the wireless communication unit comprises at least one first wireless transceiver configured for communication with the implantable medical device using a first network protocol, for determining a distance between the patient external device and the implantable medical device, and at least one second wireless transceiver configured for communication with the implantable medical device using a second network protocol, for transferring data between the patient external device and the implantable medical device.
According to one embodiment, the first wireless transceiver is configured for transcutaneous energy transfer for at least one of: powering an energy consuming component of the implantable medical device and charging an implantable energy storage unit.
According to one embodiment, the standard network protocol is one from the list of: Radio Frequency type protocol, RFID type protocol, WLAN type protocol, Bluetooth type protocol, BLE type protocol, NFC type protocol, 3G/4G/5G type protocol, and GSM type protocol.
According to one embodiment, a communication range of the first wireless transceiver is less than a communication range of the second wireless transceiver.
According to one embodiment, at least one of: the patient external device is configured to authenticate the implantable medical device if a distance between the patient external device and the implantable medical device is less than a predetermined threshold value, the patient external device is configured to be authenticated by the implantable medical device if a distance between the patient external device and the implantable medical device is less than a predetermined threshold value, the patient external device is configured to authenticate the patient display device if a distance between the patient external device and the patient display device is less than a predetermined threshold value, and the patient external device is configured to be authenticated by the implantable medical device if a distance between the patient external device and the patient display device is less than a predetermined threshold value.
According to one embodiment, the patient external device is configured to allow the transfer of data between at least one of: the patient external device and the implantable medical device, and the patient external device and the patient display device, on the basis of the authentication.
According to one embodiment, the computing unit is configured to encrypt at least one of the control interface and the control commands.
According to one embodiment, the implantable medical device comprises at least one of: an external heart compression device, an apparatus assisting the pump function of a heart of the patient, an apparatus assisting the pump function comprising a turbine bump placed within a patient's blood vessel for assisting the pump function of the heart, an operable artificial heart valve, an operable artificial heart valve for increasing the blood flow to the coronary arteries. an implantable drug delivery device, an implantable drug delivery device for injecting directly into a blood vessel and change the position of the injection site, all from within the patient's body, an implantable drug delivery device for injecting potency enhancing drugs into an erectile tissue of the patient, a hydraulic, mechanic, and/or electric constriction implant, an operable volume filling device, an operable gastric band, an operable implant for stretching the stomach wall of the patient for creating satiety, an implant configured to sense the frequency of the patient ingesting food, an operable cosmetic implant, an operable cosmetic implant for adjust the shape and/or size in the breast region of a patient, an implant controlling medical device for the emptying of a urinary bladder, an implant hindering urinary leakage, an implant hindering anal incontinence, an implant controlling the emptying of fecal matter, an implant monitoring an aneurysm, an implant for hindering the expansion of an aneurysm, an implant lubricating a joint, an implant for affecting the blood flow to an erectile tissue of the patient, an implant for simulating the engorgement of an erectile tissue, an implant with a reservoir for holding bodily fluids, an implant storing and/or emptying a bodily reservoir or a surgically created reservoir, an implant communicating with a database outside the body, an implant able to be programmed from outside the body, an implant able to be programmed from outside the body with a wireless signal, an implant treating impotence, an implant controlling the flow of eggs in the uterine tube, an implant controlling the flow of sperms in the uterine tube, an implant controlling the flow of sperms in the vas deferens, an implant for hindering the transportation of the sperm in the vas deferens, an implant treating osteoarthritis, an implant performing a test of parameters inside the body, an implant controlling specific treatment parameters from inside the body, an implant controlling bodily parameters from inside the body, an implant controlling the blood pressure, an implant controlling the blood pressure by affecting the dilatation of the renal artery, an implant controlling a drug treatment parameter, an implant controlling a parameter in the blood, an implant for adjusting or replacing any bone part of a body of the patient, an implant replacing an organ of the patient or part of an organ of the patient or the function thereof, a vascular treatment device, an implant adapted to move fluid inside the body of the patient, an implant configured to sense a parameter related to the patient swallowing, an implant configured to exercise a muscle with electrical or mechanical stimulation, an implant configured for emptying an intestine portion on command, an operable implant configured to be invaginated in the stomach of the patient to reduce the volume of the stomach substantially more than the volume of the device, an implant configured for emptying the urinary bladder from within the patient's body by compressing the bladder, an implant configured for draining fluid from within the patient's body, an implant configured for the active lubrication of a joint with an added lubrication fluid, an implant configured for removing clots and particles from the patient's blood stream, an implant configured for elongating or straightening a bone in the patient, to reduce scoliosis, a device to stimulate the brain for a several position to a focused point, an artificial stomach replacing the function of the natural stomach, an implant configured for adjusting the position of a female's urinary tract or bladder neck, an implant configured for stimulating the ampulla vas deference and creating temporary constriction.
According to one embodiment, the system comprises a master private key device configured to allow issuance of a new private key device, wherein the HCP or HCP admin have such master private key device adapted to able to replace and pair a new patient private key device or HCP private key device into the system, through the HCP EID external device.
According to one embodiment, the patient remote external device and the patient EID external device are an integrated unit.
According to one embodiment, the HCP dedicated device and the HCP EID external device are an integrated unit.
According to one embodiment, the system comprises a measurement device or sensor adapted to deliver a measurement to at least one of the DDI, patent EID external device and a patient display device.
According to one embodiment, the system comprises a food sensor, adapted to measure at least if the patient swallows solid food or is drinking fluid, wherein said food sensor is connected to the control unit of a medical device to cause an action to stretch the stomach after a determined amount of food intake.
According to one embodiment, the patient display device further comprises an auxiliary wireless communication unit. The auxiliary wireless communication unit is configured to be disabled to enable at least one of: wirelessly receiving the implant control interface as the remote display portal from the patient remote external device, and wirelessly transmitting implant control user input to the patient remote external device.
According to one embodiment, the wireless communication unit is configured for wireless communication with the patient remote external device using a standard network protocol. The standard network protocol may be one from the list of: Radio Frequency type protocol, RFID type protocol, WLAN type protocol, Bluetooth type protocol, BLE type protocol, NFC type protocol, 3G/4G/5G type protocol, and GSM type protocol.
According to one embodiment, the wireless communication unit is configured for wireless communication with the patient remote external device using a proprietary network protocol.
According to one embodiment, the wireless communication unit comprises a Bluetooth transceiver.
According to one embodiment, the wireless communication unit comprises a UWB transceiver.
According to one embodiment, a communication range of the wireless communication unit is less than a communication range of the auxiliary wireless communication unit.
According to one embodiment, the patient display device is configured to authenticate the patient remote external device if a distance between the patient display device and the patient remote external device is less than a predetermined threshold value, or to be authenticated by the patient remote external device if a distance between the patient display device and the patient remote external device is less than a predetermined threshold value.
According to one embodiment, the patient display device is configured to allow the transfer of data between the patient display device and the patient remote external device on the basis of the authentication.
According to one embodiment, the patient display device is a wearable external device or a handset.
According to one embodiment, the system comprises a master private key device configured to allow issuance of a new private key device, wherein the HCP or HCP admin have such master private key device adapted to able to replace and pair a new patient private key device or HCP private key device into the system, through the HCP EID external device.
According to one embodiment, the patient remote external device and the patient EID external device are an integrated unit.
According to one embodiment, the HCP dedicated device and the HCP EID external device are an integrated unit.
According to one embodiment, the system comprises a measurement device or sensor adapted to deliver a measurement to at least one of the DDI, patent EID external device and a patient display device.
According to one embodiment, the system comprises a food sensor, adapted to measure at least if the patient swallows solid food or is drinking fluid, wherein said food sensor is connected to the control unit of a medical device to cause an action to stretch the stomach after a determined amount of food intake.
According to one embodiment, the computing unit is configured to encrypt at least one of the control interface and the control commands.
According to one embodiment, the patient display device is configured to encrypt the user input.
According to one embodiment, the server is configured to encrypt at least one of the user input received from the patient display device and the control interface received from the patient remote external device.
According to one embodiment, the computing unit is configured to encrypt the control interface and the patient display device is configured to decrypt the encrypted control interface.
According to one embodiment, the server is configured to act as a router, transferring the encrypted control interface from the patient remote external device to the patient display device without decryption.
According to one embodiment of the communication system or patient display device the implantable medical device comprises at least one of: an external heart compression device, an apparatus assisting the pump function of a heart of the patient, an apparatus assisting the pump function comprising a turbine bump placed within a patient's blood vessel for assisting the pump function of the heart, an operable artificial heart valve, an operable artificial heart valve for increasing the blood flow to the coronary arteries. an implantable drug delivery device, an implantable drug delivery device for injecting directly into a blood vessel and change the position of the injection site, all from within the patient's body, an implantable drug delivery device for injecting potency enhancing drugs into an erectile tissue of the patient, a hydraulic, mechanic, and/or electric constriction implant, an operable volume filling device, an operable gastric band, an operable implant for stretching the stomach wall of the patient for creating satiety, an implant configured to sense the frequency of the patient ingesting food, an operable cosmetic implant, an operable cosmetic implant for adjust the shape and/or size in the breast region of a patient, an implant controlling medical device for the emptying of a urinary bladder, an implant hindering urinary leakage, an implant hindering anal incontinence, an implant controlling the emptying of fecal matter, an implant monitoring an aneurysm, an implant for hindering the expansion of an aneurysm, an implant lubricating a joint, an implant for affecting the blood flow to an erectile tissue of the patient, an implant for simulating the engorgement of an erectile tissue, an implant with a reservoir for holding bodily fluids, an implant storing and/or emptying a bodily reservoir or a surgically created reservoir, an implant communicating with a database outside the body, an implant able to be programmed from outside the body, an implant able to be programmed from outside the body with a wireless signal, an implant treating impotence, an implant controlling the flow of eggs in the uterine tube, an implant controlling the flow of sperms in the uterine tube, an implant controlling the flow of sperms in the vas deferens, an implant for hindering the transportation of the sperm in the vas deferens, an implant treating osteoarthritis, an implant performing a test of parameters inside the body, an implant controlling specific treatment parameters from inside the body, an implant controlling bodily parameters from inside the body, an implant controlling the blood pressure, an implant controlling the blood pressure by affecting the dilatation of the renal artery, an implant controlling a drug treatment parameter, an implant controlling a parameter in the blood, an implant for adjusting or replacing any bone part of a body of the patient, an implant replacing an organ of the patient or part of an organ of the patient or the function thereof, a vascular treatment device, an implant adapted to move fluid inside the body of the patient, an implant configured to sense a parameter related to the patient swallowing, an implant configured to exercise a muscle with electrical or mechanical stimulation, an implant configured for emptying an intestine portion on command, an operable implant configured to be invaginated in the stomach of the patient to reduce the volume of the stomach substantially more than the volume of the device, an implant configured for emptying the urinary bladder from within the patient's body by compressing the bladder, an implant configured for draining fluid from within the patient's body, an implant configured for the active lubrication of a joint with an added lubrication fluid, an implant configured for removing clots and particles from the patient's blood stream, an implant configured for elongating or straightening a bone in the patient, to reduce scoliosis, a device to stimulate the brain for a several position to a focused point, an artificial stomach replacing the function of the natural stomach, an implant configured for adjusting the position of a female's urinary tract or bladder neck, an implant configured for stimulating the ampulla vas deference and creating temporary constriction.
According to one embodiment, the communication system further comprises a server. The server may comprise a wireless communication unit configured for wirelessly receiving an implant control interface received from the patient remote external device and wirelessly transmitting the implant control interface as a remote display portal to the patient display device. The wireless communication unit is further configured for wirelessly receiving implant control user input from a patient EID external device and wirelessly transmitting the implant control user input to the patient display device.
According to one embodiment, the system comprises a master private key device configured to allow issuance of a new private key device, wherein the HCP or HCP admin have such master private key device adapted to able to replace and pair a new patient private key device or HCP private key device into the system, through the HCP EID external device.
According to one embodiment, the patient remote external device and the patient EID external device are an integrated unit.
According to one embodiment, the HCP dedicated device and the HCP EID external device are an integrated unit.
According to one embodiment, the system comprises a measurement device or sensor adapted to deliver a measurement to at least one of the DDI, patent EID external device and a patient display device.
According to one embodiment, the system comprises a food sensor, adapted to measure at least if the patient swallows solid food or is drinking fluid, wherein said food sensor is connected to the control unit of a medical device to cause an action to stretch the stomach after a determined amount of food intake.
According to one embodiment, the first log-in is a PIN-based log-in.
According to one embodiment, at least one of the first and second log-in is a log-in based on a biometric input or a hardware key.
According to one embodiment, the patient display device further comprises an auxiliary wireless communication unit, and wherein the auxiliary wireless communication unit is configured to be disabled to enable wireless communication with the patient external device.
According to one embodiment, the patient display device is configured to wirelessly receive an implant control interface as a remote display portal from the patient external device to be displayed on the display.
According to one embodiment, the wireless communication unit is configured for wireless communication with the patient external device using a standard network protocol.
According to one embodiment, the wireless communication unit is configured for wireless communication with the patient external device using a proprietary network protocol.
According to one embodiment, the wireless communication unit is configured for wireless communication with the patient external device using a first network protocol and with the server using a second network protocol.
According to one embodiment, the wireless communication unit is configured for wireless communication with the patient external device using a first frequency band and with the server using a second frequency band.
According to one embodiment, the wireless communication unit comprises a Bluetooth transceiver.
According to one embodiment, the wireless communication unit comprises a UWB transceiver.
According to one embodiment, the standard network protocol is one from the list of: Radio Frequency type protocol, RFID type protocol, WLAN type protocol, Bluetooth type protocol, BLE type protocol, NFC type protocol, 3G/4G/5G type protocol, and GSM type protocol.
According to one embodiment, a communication range of the wireless communication unit is less than a communication range of the auxiliary wireless communication unit.
According to one embodiment, the wireless communication unit comprises a first wireless transceiver for communication with the patient external device and a second wireless transceiver for communication with the server.
According to one embodiment, the second wireless transceiver is configured to be disabled to enable wireless communication using the first wireless transceiver.
According to one embodiment, the patient display device is configured to authenticate the patient external device if a distance between the patient display device and the patient external device is less than a predetermined threshold value, or to be authenticated by the patient external device if a distance between the patient display device and the patient external device is less than a predetermined threshold value.
According to one embodiment, the patient display device is configured to allow the transfer of data between the patient display device and the patient external device on the basis of the authentication.
According to one embodiment, the patient display device is a wearable external device or a handset.
According to one embodiment, the second application is configured to receive data related to a parameter of the implanted medical device.
According to one embodiment, the second application is configured to receive data related to a sensor value received from the implanted medical device.
According to one embodiment, the second application is configured to receive data related to a parameter related to at least one of: a battery status, a temperature, a time, and an error.
According to one embodiment, the patient display device is configured to encrypt the user input.
According to one embodiment, the display is configured to encrypt the user input for decryption by the implantable medical device.
According to one embodiment, the patient display device is configured to decrypt the control interface received from the patient external device, for displaying the control interface on the display.
According to one embodiment, at least one of the first and second application is configured to receive data from an auxiliary external device and present the received data to the user.
According to one embodiment, at least one of the first and second application is configured to receive data from an auxiliary external device comprising a scale for determining the weight of the user.
According to one embodiment, at least one of the first and second application is configured to receive data related to the weight of the user from an auxiliary external device comprising a scale.
According to one embodiment, the patient display device is configured to: wirelessly transmit the data related to the weight of the user to the patient external device, or wirelessly transmit an instruction derived from the data related to the weight of the user, or wirelessly transmit an instruction derived from a combination of the data related to the weight of the user and the implant control input received from the user.
According to one embodiment, the system comprises a master private key device configured to allow issuance of a new private key device, wherein the HCP or HCP admin have such master private key device adapted to able to replace and pair a new patient private key device or HCP private key device into the system, through the HCP EID external device.
According to one embodiment, the patient remote external device and the patient EID external device are an integrated unit.
According to one embodiment, the HCP dedicated device and the HCP EID external device are an integrated unit.
According to one embodiment, the system comprises a measurement device or sensor adapted to deliver a measurement to at least one of the DDI, patent EID external device and a patient display device.
According to one embodiment, the system comprises a food sensor, adapted to measure at least if the patient swallows solid food or is drinking fluid, wherein said food sensor is connected to the control unit of a medical device to cause an action to stretch the stomach after a determined amount of food intake. According to one embodiment, the patient display device comprises a first log-in function and a second log-in function, and wherein the first log-in function gives the user access to the first application and wherein the first and second log-in function in combination gives the user access to the second application.
According to one embodiment, the second application is configured to receive data related to a parameter of the implanted medical device.
According to one embodiment, the second application is configured to receive data related to a sensor value received from the implanted medical device.
According to one embodiment, the second application is configured to receive data related to a parameter related to at least one of: a battery status, a temperature, a time, or an error.
According to one embodiment, the patient display device is configured to encrypt the user input.
According to one embodiment, the display is configured to encrypt the user input for decryption by the implantable medical device.
According to one embodiment, the patient remote external device is configured to act as a router, transferring the encrypted user input from the patient display device to the implantable medical device without decryption.
According to one embodiment, the patient remote external device is configured to encrypt at least one of the control interface and the control commands.
According to one embodiment, the patient remote external device is configured to encrypt the control interface and wherein the patient display device is configured to decrypt the encrypted control interface.
According to one embodiment, the second application is configured to receive data related to a parameter of the implanted medical device.
According to one embodiment, the second application is configured to receive data related to a sensor value received from the implanted medical device.
According to one embodiment, the second application is configured to receive data related to a parameter related to at least one of: a battery status, a temperature, a time, or an error.
According to one embodiment of the communication system, patient display device or computer program product, the implantable medical device comprises at least one of: an external heart compression device, an apparatus assisting the pump function of a heart of the patient, an apparatus assisting the pump function comprising a turbine bump placed within a patient's blood vessel for assisting the pump function of the heart, an operable artificial heart valve, an operable artificial heart valve for increasing the blood flow to the coronary arteries. an implantable drug delivery device, an implantable drug delivery device for injecting directly into a blood vessel and change the position of the injection site, all from within the patient's body, an implantable drug delivery device for injecting potency enhancing drugs into an erectile tissue of the patient, a hydraulic, mechanic, and/or electric constriction implant, an operable volume filling device, an operable gastric band, an operable implant for stretching the stomach wall of the patient for creating satiety, an implant configured to sense the frequency of the patient ingesting food, an operable cosmetic implant, an operable cosmetic implant for adjust the shape and/or size in the breast region of a patient, an implant controlling medical device for the emptying of a urinary bladder, an implant hindering urinary leakage, an implant hindering anal incontinence, an implant controlling the emptying of fecal matter, an implant monitoring an aneurysm, an implant for hindering the expansion of an aneurysm, an implant lubricating a joint, an implant for affecting the blood flow to an erectile tissue of the patient, an implant for simulating the engorgement of an erectile tissue, an implant with a reservoir for holding bodily fluids, an implant storing and/or emptying a bodily reservoir or a surgically created reservoir, an implant communicating with a database outside the body, an implant able to be programmed from outside the body, an implant able to be programmed from outside the body with a wireless signal, an implant treating impotence, an implant controlling the flow of eggs in the uterine tube, an implant controlling the flow of sperms in the uterine tube, an implant controlling the flow of sperms in the vas deferens, an implant for hindering the transportation of the sperm in the vas deferens, an implant treating osteoarthritis, an implant performing a test of parameters inside the body, an implant controlling specific treatment parameters from inside the body, an implant controlling bodily parameters from inside the body, an implant controlling the blood pressure, an implant controlling the blood pressure by affecting the dilatation of the renal artery, an implant controlling a drug treatment parameter, an implant controlling a parameter in the blood, an implant for adjusting or replacing any bone part of a body of the patient, an implant replacing an organ of the patient or part of an organ of the patient or the function thereof, a vascular treatment device, an implant adapted to move fluid inside the body of the patient, an implant configured to sense a parameter related to the patient swallowing, an implant configured to exercise a muscle with electrical or mechanical stimulation, an implant configured for emptying an intestine portion on command, an operable implant configured to be invaginated in the stomach of the patient to reduce the volume of the stomach substantially more than the volume of the device, an implant configured for emptying the urinary bladder from within the patient's body by compressing the bladder, an implant configured for draining fluid from within the patient's body, an implant configured for the active lubrication of a joint with an added lubrication fluid, an implant configured for removing clots and particles from the patient's blood stream, an implant configured for elongating or straightening a bone in the patient, to reduce scoliosis, a device to stimulate the brain for a several position to a focused point, an artificial stomach replacing the function of the natural stomach, an implant configured for adjusting the position of a female's urinary tract or bladder neck, an implant configured for stimulating the ampulla vas deference and creating temporary constriction.
According to one embodiment, the system comprises a master private key device configured to allow issuance of a new private key device, wherein the HCP or HCP admin have such master private key device adapted to able to replace and pair a new patient private key device or HCP private key device into the system, through the HCP EID external device.
According to one embodiment, the patient remote external device and the patient EID external device are an integrated unit.
According to one embodiment, the HCP dedicated device and the HCP EID external device are an integrated unit.
According to one embodiment, the system comprises a measurement device or sensor adapted to deliver a measurement to at least one of the DDI, patent EID external device and a patient display device.
According to one embodiment, the system comprises a food sensor, adapted to measure at least if the patient swallows solid food or is drinking fluid, wherein said food sensor is connected to the control unit of a medical device to cause an action to stretch the stomach after a determined amount of food intake.
According to one embodiment, the patient display device is configured to wirelessly receive an implant control interface from the patient external device to be displayed on the display.
According to one embodiment, at least two of: the wireless communication unit of the server, the wireless communication unit of the patient display device, the wireless communication unit of the patient external device, and the wireless communication unit of the implantable medical device, are configured for wireless communication using a standard network protocol.
According to one embodiment, wherein at least two of: the wireless communication unit of the server, the wireless communication unit of the patient display device, the wireless communication unit of the patient external device, and the wireless communication unit of the implantable medical device, are configured for wireless communication using a proprietary network protocol.
According to one embodiment, the wireless communication unit of the patient external device is configured to use a first network protocol for communication with the implantable medical device and use a second network protocol for communication with the server, or use a first network protocol for communication with the implantable medical device and use a second network protocol for communication with the patient display device.
According to one embodiment, the wireless communication unit of the patient external device is configured to use a first frequency band for communication with the implantable medical device and use a second frequency band for communication with the server, or use a first frequency band for communication with the implantable medical device and use a second frequency band for communication with the patient display device.
According to one embodiment, the wireless communication unit of the patient display device is configured to use a first network protocol for communication with the patient external device and use a second network protocol for communication with the server.
According to one embodiment, the wireless communication unit of the patient display device is configured to use a first frequency band for communication with the patient external device and use a second frequency band for communication with the server.
According to one embodiment, the wireless communication unit of the server is configured to use a first network protocol for communication with the patient external device and use a second network protocol for communication with the patient display device.
According to one embodiment, the wireless communication unit of the server is configured to use a first frequency band for communication with the patient external device and use a second frequency band for communication with the patient display device.
According to one embodiment, the wireless communication unit of at least one of the server, the patient display device, the patient external device, and the implantable medical device comprises a Bluetooth transceiver.
According to one embodiment, the wireless communication unit of at least one of the server, the patient display device, the patient external device, and the implantable medical device comprises a UWB transceiver.
According to one embodiment, the standard network protocol is one from the list of: Radio Frequency type protocol, RFID type protocol, WLAN type protocol, Bluetooth type protocol, BLE type protocol, NFC type protocol, 3G/4G/5G type protocol, and GSM type protocol.
According to one embodiment, the wireless communication unit of the patient external device comprises a first wireless transceiver for wireless communication with the implantable medical device, and a second wireless transceiver for wireless communication with the server, and wherein the second wireless transceiver has a longer effective range than the first wireless transceiver.
According to one embodiment, the wireless communication unit of the patient external device comprises a first wireless transceiver for wireless communication with the implantable medical device, and a second wireless transceiver for wireless communication with the patient display device, and wherein the second wireless transceiver has a longer effective range than the first wireless transceiver.
According to one embodiment, the wireless communication unit of the patient display device comprises a first wireless transceiver for wireless communication with the patient external device, and a second wireless transceiver for wireless communication with the server, and wherein the second wireless transceiver has a longer effective range than the first wireless transceiver.
According to one embodiment, the second wireless transceiver has an effective range being one of: 2 times, 4 times, 8 times 20 times, 50 times or 100 times longer than the first wireless transceiver.
According to one embodiment, the second wireless transceiver is configured to be disabled to enable wireless communication using the first wireless transceiver.
According to one embodiment, at least one of: the patient display device is configured to authenticate the patient external device if a distance between the patient display device and the patient external device is less than a predetermined threshold value, the patient display device is configured to be authenticated by the patient external device if a distance between the patient display device and the patient external device is less than a predetermined threshold value, the patient display device is configured to authenticate the implantable medical device if a distance between the patient display device and the implantable medical device is less than a predetermined threshold value, the patient display device is configured to be authenticated by the implantable medical device if a distance between the patient display device and the implantable medical device is less than a predetermined threshold value, the patient external device is configured to authenticate the patient display device if a distance between the patient external device and the patient display device is less than a predetermined threshold value, the patient external device is configured to be authenticated by the patient display device if a distance between the patient external device and the patient display device is less than a predetermined threshold value, the patient external device is configured to authenticate the implantable medical device if a distance between the patient external device and the implantable medical device is less than a predetermined threshold value, and the patient external device is configured to be authenticated by the implantable medical device if a distance between the patient external device and the implantable medical device is less than a predetermined threshold value.
According to one embodiment, the patient display device is configured to allow the transfer of data between the patient display device and the patient external device on the basis of the authentication.
According to one embodiment, the patient external device is configured to allow the transfer of data between the patient display device and the patient external device on the basis of the authentication.
According to one embodiment, the patient external device is configured to allow the transfer of data between the patient external device and the implantable medical device on the basis of the authentication.
According to one embodiment, the patient display device is a wearable patient external device or a handset.
According to one embodiment, the data encrypted by the implantable medical device is related to at least one of: a battery status, a temperature, a time, or an error.
According to one embodiment, the system comprises a master private key device configured to allow issuance of a new private key device, wherein the HCP or HCP admin have such master private key device adapted to able to replace and pair a new patient private key device or HCP private key device into the system, through the HCP EID external device.
According to one embodiment, the patient remote external device and the patient EID external device are an integrated unit.
According to one embodiment, the HCP dedicated device and the HCP EID external device are an integrated unit.
According to one embodiment, the system comprises a measurement device or sensor adapted to deliver a measurement to at least one of the DDI, patent EID external device and a patient display device.
According to one embodiment, the system comprises a food sensor, adapted to measure at least if the patient swallows solid food or is drinking fluid, wherein said food sensor is connected to the control unit of a medical device to cause an action to stretch the stomach after a determined amount of food intake.
According to one embodiment, at least one of the patient private key device or HCP private key device comprises a hardware key.
According to one embodiment, the private key device is at least one of, a smartcard, a key-ring device, a watch an arm or wrist band a neckless or any shaped device.
According to one embodiment of the system, at least two of: the HCP EID external device, the patient EID external device, the HCP private key device, the patient private key device, and the DDI are configured for wireless communication using a standard network protocol.
According to one embodiment, at least two of: the HCP EID external device, the patient EID external device, the HCP private key device, the patient private key device, and the DDI are configured for wireless communication using a proprietary network protocol.
According to one embodiment, the patient EID external device is configured to use a first network protocol for communication with the implantable medical device and use a second network protocol for communication with the DDI.
According to one embodiment, the patient EID external device is configured to use a first frequency band for communication with the implantable medical device and use a second frequency band for communication with the DDI.
According to one embodiment, the DDI is configured to use a first frequency band for communication with the patient EID external device and a second frequency band for communication with the patient private key device.
According to one embodiment, at least one of the HCP EID external device, the patient EID external device, the HCP private key device, the patient private key device and the DDI comprises a Bluetooth transceiver.
According to one embodiment, at least one of the HCP EID external device, the patient EID external device, the HCP private key device, the patient private key device and the DDI comprises a UWB transceiver.
According to one embodiment, the standard network protocol is one from the list of: Radio Frequency type protocol, RFID type protocol, WLAN type protocol, Bluetooth type protocol, BLE type protocol, NFC type protocol, 3G/4G/5G type protocol, and GSM type protocol.
According to one embodiment, the patient EID external device comprises a first wireless transceiver for wireless communication with the implantable medical device, and a second wireless transceiver for wireless communication with the DDI, and wherein the second wireless transceiver has longer effective range than the first wireless transceiver.
According to one embodiment, the patient private key device comprises a first wireless transceiver for wireless communication with the HCP EID external device, and a second wireless transceiver for wireless communication with the DDI, and wherein the second wireless transceiver has longer effective range than the first wireless transceiver.
According to one embodiment, the second wireless transceiver has an effective range being one of: 2 times, 4 times, 8 time, 20 times, 50 times or 100 times longer than the effective range of the first wireless transceiver.
According to one embodiment, the second wireless transceiver is configured to be disabled to enable wireless communication using the first wireless transceiver.
According to one embodiment, the patient EID external device is configured to allow transfer of data between the EID external device and the implantable medical device on the basis of an authentication of the patient EID external device.
According to one embodiment, the patient EID external device is a wearable patient external device or a handset.
According to one embodiment, the data encrypted by the implantable medical device is related to at least one of: a battery status, a temperature, a time, or an error.
According to one embodiment, the system comprises a master private key device configured to allow issuance of a new private key device, wherein the HCP or HCP admin have such master private key device adapted to able to replace and pair a new patient private key device or HCP private key device into the system, through the HCP EID external device.
According to one embodiment, the patient remote external device and the patient EID external device are an integrated unit.
According to one embodiment, the HCP dedicated device and the HCP EID external device are an integrated unit.
According to one embodiment, the system comprises a measurement device or sensor adapted to deliver a measurement to at least one of the DDI, patent EID external device and a patient display device.
According to one embodiment, the system comprises a food sensor, adapted to measure at least if the patient swallows solid food or is drinking fluid, wherein said food sensor is connected to the control unit of a medical device to cause an action to stretch the stomach after a determined amount of food intake.
According to one embodiment, the HCP EID external device further comprises a wireless transceiver configured for communication with the implanted medical device through a second network protocol.
According to one embodiment, the HCP private key device is adapted to be provided to the at least one HCP external device via at least one of: a reading slot or comparable for the HCP private key device, a RFID communication, and a close distance wireless activation communication unit, or electrical direct contact.
According to one embodiment, the HCP EID external device comprises at least one of reading slot or comparable for the HCP private key device, a RFID communication and a close distance wireless activation communication unit, or electrical direct contact.
According to one embodiment, the HCP EID external device is adapted to receive a command from a HCP dedicated device to change said pre-programmed treatment steps of the implantable medical device, when implanted, wherein the HCP dedicated device is further adapted to be activated, authenticated, and allowed to perform said command by the HCP providing their private key.
According to one embodiment, at least two of: the HCP EID external device, the patient EID external device, the HCP private key device, and the patient private key device, are configured for wireless communication using a standard network protocol.
According to one embodiment, at least two of: the HCP EID external device, the patient EID external device, the HCP private key device, and the patient private key device, are configured for wireless communication using a proprietary network protocol.
According to one embodiment, the patient EID external device is configured to use a first network protocol for communication with the implantable medical device and use a second network protocol for communication with the patient private key device.
According to one embodiment, the patient EID external device is configured to use a first frequency band for communication with the implantable medical device and use a second frequency band for communication with the patient private key device.
According to one embodiment, at least one of the HCP EID external device, the patient EID external device, the HCP private key device, and the patient private key device comprises a Bluetooth transceiver.
According to one embodiment, at least one of the HCP EID external device, the patient EID external device, the HCP private key device, and the patient private key device comprises a UWB transceiver.
According to one embodiment, the standard network protocol is one from the list of: Radio Frequency type protocol, RFID type protocol, WLAN type protocol, Bluetooth type protocol, BLE type protocol, NFC type protocol, 3G/4G/5G type protocol, and GSM type protocol.
According to one embodiment, the patient EID external device comprises a first wireless transceiver for wireless communication with the implantable medical device, and a second wireless transceiver for wireless communication with the patient private key device, and wherein the second wireless transceiver has longer effective range than the first wireless transceiver.
According to one embodiment, the second wireless transceiver has an effective range being one of: 2 times, 4 times, 8 time, 20 times, 50 times or 100 times longer than the effective range of the first wireless transceiver.
According to one embodiment, the second wireless transceiver is configured to be disabled to enable wireless communication using the first wireless transceiver.
According to one embodiment, the patient EID external device is configured to allow transfer of data between the EID external device and the implantable medical device on the basis of an authentication of the patient EID external device.
According to one embodiment, the patient EID external device is a wearable patient external device or a handset.
According to one embodiment, the data encrypted by the implantable medical device is related to at least one of: a battery status, a temperature, a time, or an error.
According to one embodiment, the wireless transceiver, the remote display portal, and the remote display portal are comprised in the patient remote external device.
According to one embodiment, the system further comprises the patient display device, which may comprise a supporting application, a display which hosts the Remote Display Portal, and a patient display device private key.
According to one embodiment, the remote display portal is capable of generating a command to be signed by the patient display device private key.
According to one embodiment, the patient remote external device is adapted to accept input from the patient via said patient display device through its remote display portal.
According to one embodiment, the patient remote external device comprises a graphical user interface arranged on a touch-responsive display exposing buttons to express actuation functions of the implanted medical device.
According to one embodiment, the system is configured to allow the patient to actuate the implant at home through the patient remote external device by means of an authorization granted by a patient private key.
According to one embodiment, the patient private key comprises at least one of: a smart card, a keyring device, a watch, a arm or wrist band, a necklace, and any shaped device.
According to one embodiment, the system is configured to allow the patient to actuate the implantable medical device, when implanted, at home through the patient remote external device, using an authorization granted by the patient private key.
According to one embodiment, system further comprises a patient EID external device comprising at least one of: a reading slot or comparable for the patient private key device, a RFID communication, and a close distance wireless activation communication, or electrical direct contact.
According to one embodiment, the patient EID external device is adapted to be synchronised with the patient remote external device.
According to one embodiment, the patient EID external device further comprises at least one of: a wireless transceiver configured for communication with the patient, a remote external device, and a wired connector for communication with the patient remote external device.
According to one embodiment, the patient EID external device is adapted to generate an authorization to be signed by the patient private key to be installed into at least one of: the patient remote external device through the patient EID external device, and the implantable medical device.
According to one embodiment, the system comprises a patient display device comprising a supporting application capable of displaying the remote display portal with content delivered from the patient remote external device.
According to one embodiment, the remote display portal and patient remote external device are adapted to expose buttons to express the will to actuate the functions of the implanted medical device by the patient through the patient remote external device.
According to one embodiment, the patient display device comprises at least one of: a display which hosts the remote display portal, and a patient display device private key.
According to one embodiment, the remote display portal is capable of generating a command to be signed by the patient private key.
According to one embodiment, the system comprises a master private key device configured to allow issuance of a new private key device, wherein the HCP or HCP admin have such master private key device adapted to able to replace and pair a new patient private key device or HCP private key device into the system, through the HCP EID external device.
According to one embodiment, the patient remote external device and the patient EID external device are an integrated unit.
According to one embodiment, the HCP dedicated device and the HCP EID external device are an integrated unit.
According to one embodiment, the system comprises a measurement device or sensor adapted to deliver a measurement to at least one of the DDI, patent EID external device and a patient display device.
According to one embodiment, the system comprises a food sensor, adapted to measure at least if the patient swallows solid food or is drinking fluid, wherein said food sensor is connected to the control unit of a medical device to cause an action to stretch the stomach after a determined amount of food intake.
According to one embodiment, the at least one patient EID external device is adapted to receive information from the implant, through a second network protocol.
According to one embodiment, the system comprises the DDI, wherein the DD1 is adapted to receive information from said patient EID external device, and wherein the DDI comprises a wireless transceiver configured for communication with said patient EID external device.
According to one embodiment, the patient EID external device is adapted to receive a command relayed by the DDI, to further send the command to the implanted medical device to change said pre-programmed treatment settings of the implanted medical device, and further adapted to be activated and authenticated and allowed to perform said command by the patient providing the patient private key.
According to one embodiment, the patient private key device is adapted to provide the patient private key to the patient EID external device by the patient via at least one of; a reading slot or comparable for the patient private key device, an RFID communication or other close distance wireless activation communication, or electrical direct contact.
According to one embodiment, the patient EID external device comprises at least one of: a reading slot or comparable for the HCP private key device, a RFID communication, and other close distance wireless activation communication, or direct electrical contact.
According to one embodiment, the patient EID external device further comprising at least one wireless transceiver configured for communication with the implanted medical device through a second network protocol.
According to one embodiment, the system comprises the implantable medical device, which may be adapted to, when implanted, treat the patient or perform a bodily function.
According to one embodiment, the patient private key comprises at least one of: a smart card, a keyring device, a watch, an arm band or wrist band, a necklace, and any shaped device.
According to one embodiment, at least two of: the patient EID external device, the IDD, and the patient private key device, are configured for wireless communication using a standard network protocol.
According to one embodiment, at least two of: the patient EID external device, the IDD, and the patient private key device, are configured for wireless communication using a proprietary network protocol.
According to one embodiment, the patient EID external device is configured to use a first network protocol for communication with the implantable medical device and use a second network protocol for communication with the patient private key device.
According to one embodiment, the patient EID external device is configured to use a first frequency band for communication with the implantable medical device and use a second frequency band for communication with the patient private key device.
According to one embodiment, at least one of the patient EID external device, the patient private key device and the IDD comprises a Bluetooth transceiver.
According to one embodiment, at least one of the patient EID external device, the patient private key device and the IDD comprises a UWB transceiver.
According to one embodiment, the standard network protocol is one from the list of: Radio Frequency type protocol, RFID type protocol, WLAN type protocol, Bluetooth type protocol, BLE type protocol, NFC type protocol, 3G/4G/5G type protocol, and GSM type protocol.
According to one embodiment, the patient EID external device comprises a first wireless transceiver for wireless communication with the implantable medical device, and a second wireless transceiver for wireless communication with the patient private key device, and wherein the second wireless transceiver has longer effective range than the first wireless transceiver.
According to one embodiment, the second wireless transceiver has an effective range being one of: 2 times, 4 times, 8 time, 20 times, 50 times or 100 times longer than the effective range of the first wireless transceiver.
According to one embodiment, the second wireless transceiver is configured to be disabled to enable wireless communication using the first wireless transceiver.
According to one embodiment, the patient EID external device is a wearable patient external device or a handset.
According to one embodiment, the data encrypted by the implantable medical device is related to at least one of: a battery status, a temperature, a time, or an error.
According to one embodiment, the system comprises a master private key device configured to allow issuance of a new private key device, wherein the HCP or HCP admin have such master private key device adapted to able to replace and pair a new patient private key device or HCP private key device into the system, through the HCP EID external device.
According to one embodiment, the patient remote external device and the patient EID external device are an integrated unit.
According to one embodiment, the HCP dedicated device and the HCP EID external device are an integrated unit.
According to one embodiment, the system comprises a measurement device or sensor adapted to deliver a measurement to at least one of the DDI, patent EID external device and a patient display device.
According to one embodiment, the system comprises a food sensor, adapted to measure at least if the patient swallows solid food or is drinking fluid, wherein said food sensor is connected to the control unit of a medical device to cause an action to stretch the stomach after a determined amount of food intake.
According to one embodiment, the at least one patient remote external device comprises a patient remote external device private key, wherein the DDI via the patient EID external device is able to inactivate the authority and authenticating function of the patient remote external device, thereby inactivating the patient remote external device.
According to one embodiment, the patient EID external device comprises at least one wireless transceiver configured for communication with the DD1 via a first network protocol.
According to one embodiment, the system comprises the DDI, wherein the DDI is adapted to receive command from a HCP EID external device, and to send the received command to the patient EID external device, wherein the DDI comprises a wireless transceiver configured for communication with said patient external device.
According to one embodiment, the patient EID external device is adapted to receive the command from the DDI, wherein the command originates from a health care provider, HCP, and wherein the patient EID is adapted to inactivate the patient private key and to send the command to the implanted medical device.
According to one embodiment, the patient EID external device is adapted to receive the command from the DDI, wherein the command originates from a health care provider, HCP, wherein the patient EID external device is adapted to receive the command from the HCP via the DDI to inactivate the patient remote external device comprising a patient remote external device private key, and wherein the patient EID external device is further adapted to send this command to the implanted medical device.
According to one embodiment, the patient EID external device further comprises at least one wireless transceiver configured for communication with the implanted medical device through a second network protocol.
According to one embodiment, at least one of the patient private key and a patient remote external device private key comprises a hardware key.
According to one embodiment, the private key device is at least one of, a smartcard, a key-ring device, a watch an arm or wrist band a neckless or any shaped device.
According to one embodiment, at least two of: the patient remote external device, the patient EID external device, the patient private key device, and the DDI, are configured for wireless communication using a standard network protocol.
According to one embodiment, wherein at least two of: the patient remote external device, the patient EID external device, the patient private key device, and the DDI, are configured for wireless communication using a proprietary network protocol.
According to one embodiment, the patient EID external device is configured to use a first network protocol for communication with the implantable medical device and use a second network protocol for communication with the patient private key device.
According to one embodiment, the patient EID external device is configured to use a first frequency band for communication with the implantable medical device and use a second frequency band for communication with the patient private key device.
According to one embodiment, at least one of the patient remote external device, the patient EID external device, the patient private key device, and the DDI, comprise a Bluetooth transceiver.
According to one embodiment, at least one of the patient remote external device, the patient EID external device, the patient private key device, and the DDI, comprise an UWB transceiver.
According to one embodiment, the standard network protocol is one from the list of: Radio Frequency type protocol, RFID type protocol, WLAN type protocol, Bluetooth type protocol, BLE type protocol, NFC type protocol, 3G/4G/5G type protocol, and GSM type protocol.
According to one embodiment, the patient EID external device comprises a first wireless transceiver for wireless communication with the implantable medical device, and a second wireless transceiver for wireless communication with the patient private key device, and wherein the second wireless transceiver has longer effective range than the first wireless transceiver.
According to one embodiment, the second wireless transceiver has an effective range being one of: 2 times, 4 times, 8 time, 20 times, 50 times or 100 times longer than the effective range of the first wireless transceiver.
According to one embodiment, the second wireless transceiver is configured to be disabled to enable wireless communication using the first wireless transceiver.
According to one embodiment, the patient EID external device is a wearable patient external device or a handset.
According to one embodiment, the data encrypted by the implantable medical device is related to at least one of: a battery status, a temperature, a time, or an error.
According to one embodiment, the system comprises a master private key device configured to allow issuance of new private key device, wherein the HCP or HCP admin have such master private key device adapted to be able to replace and pair a new patient private key device or HCP private key device into the system, through the HCP EID external device.
According to one embodiment, the patient remote external device and the patient EID external device are an integrated unit.
According to one embodiment, the HCP dedicated device and the HCP EID external device are an integrated unit.
According to one embodiment, the system comprises a measurement device or sensor adapted to deliver a measurement to at least one of the DDI, patent EID external device and a patient display device.
According to one embodiment, the system comprises a food sensor, adapted to measure at least if the patient swallows solid food or is drinking fluid, wherein said food sensor is connected to the control unit of a medical device to cause an action to stretch the stomach after a determined amount of food intake.
According to one embodiment, the system comprises a master private key device that allow issuance of new private key device wherein the HCP or HCP admin have such master private key device adapted to be able to replace and pair a new patient private key device or HCP private key device into the system, through the HCP EID external device.
According to one embodiment, the patient remote external device and the patient EID external device are an integrated unit.
According to one embodiment, the HCP dedicated device and the HCP EID external device are an integrated unit.
According to one embodiment, the system further comprises a measurement device or sensor adapted to deliver a measurement to at least one of the DDI, patent EID external device and a patient display device.
According to one embodiment, the system further comprises a food sensor adapted to measure at least if the patient swallows solid food or is drinking fluid, wherein said food sensor is configured to be connected to the control unit of a medical device to cause an action to stretch the stomach after a determined amount of food intake.
According to one embodiment, the HCP EID external device further comprises a wireless transceiver configured for communication with the implanted medical device through a second network protocol.
According to one embodiment, the HCP private key device is adapted to be provided to the at least one HCP external device via at least one of: a reading slot or comparable for the HCP private key device, a RFID communication, and a close distance wireless activation communication unit, or electrical direct contact.
According to one embodiment, the HCP EID external device comprises at least one of: reading slot or comparable for the HCP private key device, a RFID communication, and a close distance wireless activation communication unit, or electrical direct contact.
According to one embodiment, the HCP EID external device is adapted to receive a command from an HCP dedicated device to change said pre-programmed treatment steps of the implantable medical device, when implanted, wherein the HCP dedicated device is further adapted to be activated, authenticated, and allowed to perform said command by the HCP providing their private key.
According to one embodiment, the HCP EID external device and the HCP private key device are configured for wireless communication using a standard network protocol.
According to one embodiment, the HCP EID external device and the HCP private key device are configured for wireless communication using a proprietary network protocol.
According to one embodiment, the HCP EID external device is configured to use a first network protocol for communication with the implantable medical device and use a second network protocol for communication with the HCP private key device.
According to one embodiment, the HPC EID external device is configured to use a first frequency band for communication with the implantable medical device and use a second frequency band for communication with the HCP private key device.
According to one embodiment, at least one of the HCP EID external device and the HCP private key device comprises a Bluetooth transceiver.
According to one embodiment, at least one of the HCP EID external device and the HCP private key device comprises a UWB transceiver.
According to one embodiment, the HCP private key device comprising a HCP private key, comprising at least one of: a smart card, a keyring device, a watch, an arm or wrist band, a necklace, and any shaped device.
According to one embodiment, the patient private key device comprises a patient private key, comprising at least one of: a smart card, a keyring device, a watch, an arm or wrist band, a necklace, and any shaped device.
According to one embodiment, the patient private key is adapted to activate, be authenticated, and allowed to perform said command provided by the HCP, either via the HCP EID external device or when the action is performed remotely via a patient EID external device.
According to one embodiment, the system further comprises a dedicated data infrastructure, DDI, the patient EID external device, and the HCP EID external device, wherein the communication between the patient EID external device and the HCP EID external device is performed via the DDI.
According to one embodiment, the system comprises a master private key device that allows issuance of new private key device wherein the HCP or HCP admin have such master private key device adapted to be able to replace and pair a new patient private key device or HCP private key device into the system.
According to one embodiment, the patient remote external device and the patient EID external device are an integrated unit.
According to one embodiment, the HCP dedicated device and the HCP EID external device are an integrated unit.
According to one embodiment, the system further comprises a measurement device or sensor adapted to deliver a measurement to at least one of the DDI, patent EID external device and patient display device.
According to one embodiment, the system comprises a food sensor, adapted to measure at least if the patient swallow solid food or is drinking fluid, wherein said food sensor is connected to the control unit of a medical device to cause an action to stretch the stomach after a determined amount of food intake.
According to one embodiment, the HCP EID external device further comprises a wireless transceiver configured for communication with the implanted medical device through a second network protocol.
According to one embodiment, the HCP private key device is adapted to be provided to the at least one HCP external device via at least one of: a reading slot or comparable for the HCP private key device, a RFID communication, and a close distance wireless activation communication unit, or electrical direct contact.
According to one embodiment, the HCP EID external device comprises at least one of: reading slot or comparable for the HCP private key device, a RFID communication, and a close distance wireless activation communication unit, or electrical direct contact.
According to one embodiment, the HCP EID external device is adapted to receive a command from an HCP dedicated device to change said pre-programmed treatment steps of the implantable medical device, when implanted, wherein the HCP dedicated device is further adapted to be activated, authenticated, and allowed to perform said command by the HCP providing their private key.
According to one embodiment, the HCP EID external device and the HCP private key device are configured for wireless communication using a standard network protocol.
According to one embodiment, the HCP EID external device and the HCP private key device are configured for wireless communication using a proprietary network protocol.
According to one embodiment, the HCP EID external device is configured to use a first network protocol for communication with the implantable medical device and use a second network protocol for communication with the HCP private key device.
According to one embodiment, the HPC EID external device is configured to use a first frequency band for communication with the implantable medical device and use a second frequency band for communication with the HCP private key device.
According to one embodiment, at least one of the HCP EID external device and the HCP private key device comprises a Bluetooth transceiver.
According to one embodiment, at least one of the HCP EID external device and the HCP private key device comprises a UWB transceiver.
According to one embodiment, at least one of the patient private key device or HCP private key device comprises a hardware key.
According to one embodiment, the private key device is at least one of, a smartcard, a key-ring device, a watch an arm or wrist band a neckless or any shaped device.
According to one embodiment, the system comprises a master private key device that allow issuance of new private key device wherein the HCP or HCP admin have such master private key device adapted to be able to replace and pair a new patient private key device or HCP private key device into the system, through the HCP EID external device.
According to one embodiment, the patient remote external device and the patient EID external device is an integrated unit.
According to one embodiment, the HCP dedicated device and the HCP EID external device are an integrated unit.
According to one embodiment, the system comprises a measurement device or sensor adapted to deliver a measurement to at least one of the DDI, patent EID external device and a patient display device.
According to one embodiment, the system comprises a food sensor, adapted to measure at least if the patient swallow solid food or is drinking fluid, wherein said food sensor is connected to the control unit of a medical device to cause an action to stretch the stomach after a determined amount of food intake.
According to one embodiment, the HCP EID external device further comprises a wireless transceiver configured for communication with the implanted medical device through a second network protocol.
According to one embodiment, the HCP private key device is adapted to be provided to the at least one HCP external device via at least one of; a reading slot or comparable for the HCP private key device, a RFID communication, and a close distance wireless activation communication unit, or electrical direct contact.
According to one embodiment, the HCP EID external device comprises at least one of: reading slot or comparable for the HCP private key device, a RFID communication, and a close distance wireless activation communication unit, or electrical direct contact.
According to one embodiment, the HCP EID external device is adapted to receive a command from an HCP dedicated device to change said pre-programmed treatment steps of the implantable medical device, when implanted, wherein the HCP dedicated device is further adapted to be activated, authenticated, and allowed to perform said command by the HCP providing their private key.
According to one embodiment, the HCP EID external device and the HCP private key device are configured for wireless communication using a standard network protocol.
According to one embodiment, the HCP EID external device and the HCP private key device are configured for wireless communication using a proprietary network protocol.
According to one embodiment, the HCP EID external device is configured to use a first network protocol for communication with the implantable medical device and use a second network protocol for communication with the HCP private key device.
According to one embodiment, the HPC EID external device is configured to use a first frequency band for communication with the implantable medical device and use a second frequency band for communication with the HCP private key device.
According to one embodiment, at least one of the HCP EID external device and the HCP private key device comprises a Bluetooth transceiver.
According to one embodiment, at least one of the HCP EID external device and the HCP private key device comprises a UWB transceiver.
Any embodiment, part of embodiment, method, or part of method may be combined in any applicable way.
The invention is now described, by way of example, with reference to the accompanying drawing, in which:
In the following a detailed description of embodiments of the invention will be given with reference to the accompanying drawings. It will be appreciated that the drawings are for illustration only and are not in any way restricting the scope of the invention. Thus, any references to directions, such as “up” or “down”, are only referring to the directions shown in the figures. It should be noted that the features having the same reference numerals have the same function, a feature in one embodiment could thus be exchanged for a feature from another embodiment having the same reference numeral unless clearly contradictory. The descriptions of the features having the same reference numerals should thus be seen as complementing each other in describing the fundamental idea of the feature and thereby showing the features versatility.
Restriction of the luminary organ is to be understood as any operation decreasing a cross-sectional area of the luminary organ. The restriction may decrease the flow of matter in the lumen or may completely close the lumen such that no matter can pass.
A luminary organ is any organ in which a lumen can be formed. The lumen can be formed to be filled with a bodily fluid, another type of bodily tissue, or an implantable device or fluid. Examples of luminary organs for the purpose of this application are: the urethra, the urinary bladder, the ureters, a blood vessel, an intestine (including the rectum), the bile duct, the vas deference or the oviducts. Throughout this application the urinary bladder will be the prime example used in the text and figures, it is however clear that a similar pumping device could be manufactured for other luminary organs.
A controller is to be understood as any implantable unit capable of controlling the restriction device. A controller could include a motor and/or pump or another operation device for operating the implantable hydraulic restriction device or could be separate from the operation device and only be adapted to control the operation thereof. A control signal is to be understood as any signal capable of carrying information and/or electric power such that the restriction device can be directly or indirectly controlled.
Implantable operation device is to be understood as any device or system capable of operating an active implant. An operation device could for example be an actuator such as a hydraulic actuator such as a hydraulic pump or a hydraulic cylinder, or a mechanical actuator, such as a mechanical element actuating an implant by pressing or pulling directly or indirectly on the implant, or an electro-mechanical actuator such as an electrical motor or solenoid directly or indirectly pressing or pulling on the implant.
A gear system is to be understood as any system capable of providing transmission such that work of a first form can be transmission into work of a second form. The form of the work could for example include the velocity, the force and/or the direction of the work.
Inflatable is to be understood as possible to fill with a fluid, which may be a liquid, or gaseous fluid, or a plurality of solid structures suspended in a fluid, for the purpose of expanding the inner volume of a luminary device.
In
The first and third constriction elements 101a′,101b′ are configured to exert pressure on the urinary bladder U in a first direction to constrict the urinary bladder. The second and fourth constriction elements 101a″,101b″ are configured to exert pressure on the urinary bladder U in a second direction to constrict the urinary bladder. The second distance is substantially opposite to the first direction.
In the embodiment shown in
The embodiments shown in
The embodiment shown in
The embodiment of the implantable pumping device 10 disclosed in
The implantable pumping device 10 may also comprise a control device that controls the rotor 200 to rotate so that the constriction elements 101a-101c successively constricts portions of a series of selected portions of the urinary bladder U against the elongate support element 24. In
The implantable pumping device 10 may be used in combination with any other pumping device or constriction device described within this application. For example, a constriction device may be placed upstream an implantable pumping device 10 according to
The implantable pumping device 10 of
The electrodes or electrode arrangement of the constriction devices 10a, 10b in
With regards to any one of
An implantable pumping device for evacuating urine from the urinary bladder U of a patient may comprise at least two constriction devices as disclosed in
The first and second support elements 24a, 24b each comprises a curvature C adapted for the curvature of the urinary bladder U such that the implantable pumping device 10 fits snuggly around the urinary bladder U such that the distance that the operable hydraulic constriction elements 101a′, 101a″ needs to expand to constrict the urinary bladder U is kept at a minimum. In the embodiment shown in
In the embodiment shown in
In the embodiment shown in
In the second support element 24b, a second conduit 109a″ comprises a first portion in the form of a third tubing which enters a tubing fixation portion 25b fixated to, or materially integrated with, the second support element 24b. In the tubing fixation portion 25b the fluid conduit 109a″ is transferred into a third integrated channel 23c in the second support element 24b. The third integrated channel 23c is drilled, milled or casted into the material of the second support element 24b. The second support element 24b comprises an inner surface 28b which is directed towards the urinary bladder U, when the implantable pumping device 10 is implanted. The inner surface 28b of the second support element 24b comprises a fixation surface for fixating the second and fourth operable hydraulic constriction elements 101a″,101a″′. The fixation surface also comprises an outlet from the third integrated channel 23c into the second operable hydraulic constriction element 101a″, such that fluid can be transferred from the first tubing to the third integrated channel 23c and into the second operable hydraulic constriction element 101a″ for expanding the second operable hydraulic constriction element 101a″. A tubing portion of the fourth fluid conduit 109a″′ also enters the tubing fixation portion 25b fixated to, or materially integrated with, the second support element 24b. In the tubing fixation portion 25b the fourth fluid conduit 109a″′ is transferred into a fourth integrated channel 23d in the second support element 24b. The fourth integrated channel 23d is also drilled, milled or casted into the material of the second support element 24b. The fixation surface also comprises an outlet from the fourth integrated channel 23d into the fourth operable hydraulic constriction element 101a″′, such that fluid can be transferred from the fourth tubing to the fourth integrated channel 23d and into the fourth operable hydraulic constriction element 101a″′ for expanding the fourth operable hydraulic constriction element 101a″′. The tubing portion of the fluid conduits 109a′, 109a″, 109a″′, 109a″′ is preferably made from a biocompatible material such as silicone and/or polyurethane.
Integrating the fluid conduit(s) in the support element(s) enables the fluid entry to the operable hydraulic constriction elements 101a′, 101a″, 101a″′, 101a″′ to be protected and encapsulated by the support element(s) which reduces the space occupied by the operable hydraulic constriction element 10 and reduces the amount of protruding portions thus reducing the risk of damaging the urinary bladder U.
The first constriction device 10a shown in
The first and third operable hydraulic constriction element 101a′,101a″′ may be connected to a shared first hydraulic system, such that the hydraulic fluid can be pumped from the first operable hydraulic constriction element 101a′ to the third operable hydraulic constriction element 101a″′ for releasing the constriction of the urinary bladder U for restoring the flow of fluid therethrough, and pumped from the third operable hydraulic constriction element 101a″′ to the first operable hydraulic constriction element 101a′ for constricting the urinary bladder U and restricting the flow of fluid therethrough.
The second and fourth operable hydraulic constriction element 101a″, 101a″′ may be connected to a shared second hydraulic system, such that the hydraulic fluid can be pumped from the second operable hydraulic constriction element 101a″ to the fourth operable hydraulic constriction element 101a″′ for releasing the constriction of the urinary bladder U for restoring the flow of fluid therethrough, and pumped from the fourth operable hydraulic constriction element 101a″′ to the second operable hydraulic constriction element 101a″ for constricting the urinary bladder U and restricting the flow of fluid therethrough.
The shared first and second hydraulic systems may be separate from each other and thus without fluid communication. The advantage of having the first and second operable hydraulic constriction element 101a′, 101a″ connected to separate hydraulic systems is that the first and second operable hydraulic constriction element 101a′, 101a″ may be filled the same amount of hydraulic fluid irrespective of the amount of resistance from the urinary bladder U that the respective first and second operable hydraulic constriction element 101a′, 101a″ encounters. This means that the urinary bladder U will always be centered in the first construction device, and thus in the implantable pumping device 10, which reduced the risk of tissue damage to the urinary bladder U.
The first, second, third and fourth operable hydraulic constriction element 101a′, 101a″, 101a″′, 101a″′ may be connected to a shared hydraulic system, such that the hydraulic fluid can be pumped from the first and second operable hydraulic constriction element 101a′, 101a″ to the third and fourth operable hydraulic constriction element 101a″′, 101a″′ for releasing the constriction of the urinary bladder U for restoring the flow of fluid therethrough, and pumped from the third and fourth operable hydraulic constriction element 101a″′, 101a″′ to the first and second operable hydraulic constriction element 101a′, 101a″ for constricting the urinary bladder U and restricting the flow of fluid therethrough.
The first and second operable hydraulic constriction element 101a′, 101a″ have smaller volumes than the third and fourth operable hydraulic constriction element 101a″′, 101a″′. In the embodiment of
An implantable pumping device according to the one embodiment may include a first constriction device 10a according to the embodiment shown in
When closed, the surrounding structure 20 is substantially rigid and has a modulus of elasticity (E), radially, in the range 0,2 GPa-1000 GPa or in the range 1 GPa-400 GPa. I.e. the modulus of elasticity calculated as the elastic deformation of an area of the inner surface 22 of the surrounding structure 20 causing an elongation in the radius R at that area when a force is applied to that area from the center of the surrounding structure 20. In the embodiment shown in
In
The first operable hydraulic constriction element 101a′ is connected to a first hydraulic system and the second operable hydraulic constriction element 101a″ is connected to a second hydraulic system separate from the first hydraulic system. The advantage of having the first and second operable hydraulic constriction element 101a′,101a″ connected to separate hydraulic systems is that the first and second operable hydraulic constriction element 101a′,101a″ may be filled the same amount of hydraulic fluid irrespective of the amount of resistance from the urinary bladder U that the respective first and second operable hydraulic constriction element 101a′,101a″ encounters. This means that the urinary bladder U will always be centered in the implantable pumping device 10 which reduced the risk of tissue damage to the urinary bladder U. Similarly, the third and fourth operable hydraulic constrict elements (not shown) may be connected to separate hydraulic systems.
A major portion of the all the support elements of the embodiments of
In the embodiments of
Any of the embodiments disclosed in regard to
f discloses an embodiment of a first constriction device 10a or of an implantable pumping device 10 placed around a luminary organ U. In the figures the luminary organ U is a generic luminary organ U, however for the following text it will be referred to as a urinary bladder U for clarity. The embodiment disclosed in
The first operable hydraulic constriction element 101a is configured to be placed at a first portion p1 of the urinary bladder U for constricting the first portion p1 of the urinary bladder U for restricting the flow of fluid therethrough, and the second operable hydraulic constriction element 101b is configured to be placed at a second portion p2 of the urinary bladder U, downstream the first portion p1, for constricting the second portion p2 of the urinary bladder U for restricting the flow of fluid therethrough.
The lumen 103a of the first operable hydraulic constriction element 101a is connected to the lumen 103b of the second operable hydraulic constriction element 101b by means of an interconnecting fluid conduit 116, and as such, the first operable hydraulic constriction element 101a is in fluid connection with the second operable hydraulic constriction element 101b. The fluid connection is configured to conduct fluid from the first operable hydraulic constriction element 101a to the second operable hydraulic constriction element 101b when the pressure increases in the first operable hydraulic constriction element 101a, such that second operable hydraulic constriction element constricts 101b the second portion p2 of the urinary bladder U further.
In the embodiment shown in
In the embodiment of
As an increased pressure may be present in the second operable hydraulic constriction element 101b for a longer time than it is to be present in the first operable hydraulic constriction element 101a, the second operable hydraulic constriction element 101b may be configured to hold a higher pressure than the first operable hydraulic constriction element 101a. A wall of the second operable hydraulic constriction element 101b may be thicker than a wall of the first operable hydraulic constriction element 101a, e.g the wall of the second operable hydraulic constriction element may be more than 1,5 times as thick as the wall of the first operable hydraulic constriction element. In the alternative, or as a combination, the material of the wall of the second operable hydraulic constriction element 101b may be more durable than the material of the wall of the first operable hydraulic constriction element 101a. The material of the wall of the second operable hydraulic constriction element 101b may be made from a material which is less elastic than the material of the wall of the first operable hydraulic constriction element 101a, e.g. the material of the wall of the first operable hydraulic constriction element 101a may be more than 1.2 times as elastic as the material of the wall of the second operable hydraulic constriction element 101b.
The lumens 103a, 103b of the first and second operable hydraulic constriction elements 101a, 101b are divided by a resilient division wall 115, which in the embodiment of
In the embodiment of
The surrounding structure 20 comprises an inner surface 22 configured to face the urinary bladder U, when implanted. The portion of the wall of the first and second operable hydraulic constriction elements 101a,101b facing the inner surface 22 of the surrounding structure 20 is configured to be fixated to the inner surface 22 of the surrounding structure 20 e.g. by means of an adhesive.
In the embodiment shown in
In the embodiment shown in
The first operable hydraulic constriction element 101a is configured to be placed at a first portion p1 of the urinary bladder U for constricting the first portion p1 of the urinary bladder U for restricting the flow F of fluid therethrough, and the second operable hydraulic constriction element 101b is configured to be placed at a second portion p2 of the urinary bladder U, downstream the first portion p1, for constricting the second portion p2 of the urinary bladder U for restricting the flow F of fluid therethrough.
A first portion 109′ of a first reservoir conduit 109 is connected to the lumen 103a of the first operable hydraulic constriction element 101a and a second portion 109″ of the first reservoir conduit 109 is connected to the lumen 103b of the second operable hydraulic constriction element 101b. The lumen 103a of the first operable hydraulic constriction element 101a is connected to the lumen 103b of the second operable hydraulic constriction element 101b by means of an interconnecting fluid conduit 116, and as such, the first operable hydraulic constriction element 101a is in fluid connection with the second operable hydraulic constriction element 101b. The fluid connection is configured to conduct fluid from the first operable hydraulic constriction element 101a to the second operable hydraulic constriction element 101b when the pressure increases in the first operable hydraulic constriction element 101a, such that second operable hydraulic constriction element constricts 101b the second portion p2 of the urinary bladder U further in order to pump the urine out of the urinary bladder U. In the embodiment shown in
The lumens 103a,103b of the first and second operable hydraulic constriction elements 101a,101b are divided by a resilient division wall 115, which in the embodiment of
In the embodiment shown in
In the embodiment shown in
The pump 104 moves fluid from the reservoirs 107 to the first operable hydraulic constriction element 101a and further via the interconnecting fluid conduit 116 to the second operable hydraulic constriction element 101b for expanding the first and second operable hydraulic constriction elements 101a,101b for restricting the urinary bladder U and thereby hindering the flow of fluid though the urinary bladder U and for evacuating urine from the urinary bladder U.
Depending on which type of pump it is, there may be a need to have an electrically operable valve 105′ also connected in series with the hydraulic pump 104 to enable closure of the fluid communication between the first hydraulic constriction element 101a and the reservoir 107. However, in embodiments in which the hydraulic pump 104 is of a leak-free type that hinders leakage through the pump and/or hinders elasticity in the pump 104 and/or reservoir 107, such as for example a peristaltic pump, the electrically operable valve 105′ may be omitted.
The electrically operable valve 105 may be replaced by a hydraulic restrictor valve restricting the flow over the valve allowing a small leakage over the valve, which means that the pressures in the first operable hydraulic constriction element 101a and the second operable hydraulic constriction element 101b will reach an equilibrium over time. That time may be in the interval 1-10 minutes, or may be more than 10 seconds, or may be between 10 seconds and 1 hour or may be less than one hour.
In the embodiment of
The surrounding structure 20 comprises an inner surface 22 configured to face the urinary bladder U, when implanted. The portion of the wall of the first and second operable hydraulic constriction elements 101a,101b facing the inner surface 22 of the surrounding structure 20 is configured to be fixated to the inner surface 22 of the surrounding structure 20 e.g. by means of an adhesive.
In the embodiment shown in
In the embodiment shown in
The first operable hydraulic constriction element 101a is configured to be placed at a first portion p1 of the urinary bladder U for constricting the first portion p1 of the urinary bladder U for restricting the flow of fluid therethrough, and the second operable hydraulic constriction element 101b is configured to be placed at a second portion p2 of the urinary bladder U, downstream the first portion p1, for constricting the second portion p2 of the urinary bladder U for restricting the flow of fluid therethrough and for pumping urine from the urinary bladder U.
A first portion 109′ of a first reservoir conduit 109 is connected to the lumen 103a of the first operable hydraulic constriction element 101a and a second portion 109″ of the first reservoir conduit 109 is connected to the lumen 103b of the second operable hydraulic constriction element 101b. The lumen 103a of the first operable hydraulic constriction element 101a is connected to the lumen 103b of the second operable hydraulic constriction element 101b by means of an interconnecting fluid conduit 116, and as such, the first operable hydraulic constriction element 101a is in fluid connection with the second operable hydraulic constriction element 101b. The fluid connection is configured to conduct fluid from the first operable hydraulic constriction element 101a to the second operable hydraulic constriction element 101b when the pressure increases in the first operable hydraulic constriction element 101a, such that second operable hydraulic constriction element constricts 101b the second portion p2 of the urinary bladder U further. In the embodiment shown in
The lumens 103a, 103b of the first and second operable hydraulic constriction elements 101a, 101b are divided by a resilient division wall 115, which in the embodiment of
In the embodiment shown in
The pumps 104′, 104″ moves fluid from the reservoirs 107′, 107″ to the first and second operable hydraulic constriction elements 101a, 101b, respectively, for expanding the first and second operable hydraulic constriction elements 101a, 101b for restricting the urinary bladder U and thereby hindering the flow of fluid though the urinary bladder U and for evacuating urine from the urinary bladder U. When a flow should be admitted, the patient may activate the pumps 104 for moving fluid in the opposite direction, i.e. from the first and second operable hydraulic constriction elements 101′, 101″ to the reservoirs 107′, 107″, which contracts the first and second operable hydraulic constriction elements 101′, 101″ and releases the restriction of the urinary bladder U for allowing the flow of fluid therethrough.
Depending on which type of pump it is, there may be a need to have electrically operable valves connected in series with the hydraulic pumps 104′, 104″ to enable closure of the fluid communication between the first and second operable hydraulic constriction elements 101a, 101b and the first reservoirs 107′, 107″. However, in embodiments in which the hydraulic pumps 104′, 104″ are of a type that hinders leakage through the pumps and/or hinders elasticity in the pumps 104′, 104″ and/or reservoirs 107′, 107″, such as for example a peristaltic pump, an electrically operable valve may be omitted.
The electrically operable valve 119 may be replaced by a hydraulic restrictor valve restricting the flow over the valve allowing a small leakage over the valve, which means that the pressures in the first operable hydraulic constriction element 101a and the second operable hydraulic constriction element 101b will reach an equilibrium over time. That time may be in the interval 1-10 minutes, or may be more than 10 seconds, or may be between 10 seconds and 1 hour or may be less than one hour.
The implantable pumping device 10 shown in
The injection ports 108′, 108″ enables the fluid level in the hydraulic implantable pumping device 10 to be calibrated. The calibration could enable the calibration of the amount of fluid in the reservoirs 107′, 107″, the pressure in the reservoirs 107′, 107″ and/or the amount of fluid in the first and second operable hydraulic constriction element 101′, 101″, for calibrating the amount of pressure which could be exerted on the urinary bladder U. The injection ports 108′, 108″ could also be used to re-fill the system in case of leakage in the hydraulic implantable pumping device 10, or in case some of the hydraulic fluid diffuses through a material of the hydraulic implantable pumping device 10, or in case some part of the hydraulic implantable pumping device 10 distends as a result of material fatigue.
In the embodiment of
The surrounding structure 20 comprises an inner surface 22 configured to face the urinary bladder U, when implanted. The inner surface 22 of the surrounding structure 20 forms one portion of the wall of the first and second operable hydraulic constriction element 101a,101b. The resilient wall of the first and second operable hydraulic constriction element 101a,101b is fixated to the support structure by means of an adhesive.
In the embodiment shown in
In the embodiment shown in
The surrounding structure 20 and the integrated channels shown in
The first constriction device 10a comprises a first operable hydraulic constriction element 101a configured to be inflated and thereby expand in a first direction d1 towards the urinary bladder U to constrict a first portion p1 of the urinary bladder U for restricting the flow of fluid therethrough. The first operable hydraulic constriction element 101a comprises a lumen 103 surrounded by a resilient wall 102 made from a biocompatible material such as a medical grade silicone or a medical grade polyurethane-based material. A second constriction device configured to constrict a second portion of the urinary bladder U may be placed downstream the first constriction device 10a for evacuating urine from the urinary bladder U when the first portion of the urinary bladder U is closed.
The first constriction device 10a further comprises a supporting operable hydraulic constriction element 201 configured to be inflated and thereby expand in the first direction d1 towards the urinary bladder U to support the first operable hydraulic constriction element 101a in constricting the first portion p1 of the urinary bladder U for restricting the flow of fluid therethrough. The supporting operable hydraulic constriction element 201 comprises a lumen 203 surrounded by a resilient wall 202 made from a biocompatible material such as a medical grade silicone or a medical grade polyurethane-based material. The supporting operable hydraulic constriction element 201 is connected to the first operable hydraulic constriction element 101a at the contacting walls 102a, 202a of the first operable hydraulic constriction element 101a and the supporting operable hydraulic constriction element 201. The connection may be realized simply by abutment or by friction or by an adhesive or by the contacting walls 102a, 202a of the first operable hydraulic constriction element 101a and the supporting operable hydraulic constriction element 201 being materially integrated with each other by concurrent manufacturing or by subsequent thermal bonding.
In the embodiment shown in
In an alternative embodiment, which could be combined with the difference in thickness describe with reference to
In the embodiment shown in
The first constriction device 10a according to the embodiment of
The first and second hydraulic pumps 104, 204 could be a type of hydraulic pump disclosed herein. Depending on which type of pump it is, there may be a need to have electrically operable valves 105, 205 connected in series with the hydraulic pumps 104, 204 to enable closure of the fluid communication between the first operable hydraulic constriction element 101a and the first reservoir 107 and between the supporting operable hydraulic constriction element 201 and the second reservoir 207, respectively. However, in embodiments in which the hydraulic pumps are of a type that hinders leakage through the pump and/or hinders elasticity in the pump and/or reservoir, such as for example a peristaltic pump, the electrically operable valves 105, 205 may be omitted.
The first constriction device 10a shown in
The first constriction device 10a shown in
The injection ports 108, 208 enables the fluid level in the hydraulic restriction device 10a to be calibrated. The calibration could enable the calibration of the amount of fluid in the reservoirs 107, 207, the pressure in the reservoirs 107, 207 and/or the amount of fluid in the first and/or supporting operable hydraulic constriction element 101a, 201, for calibrating the amount of pressure which could be exerted on the urinary bladder U. The injection ports 108, 208 could also be used to re-fill the system in case of leakage in the hydraulic restriction device 10a, or in case some of the hydraulic fluid diffuses through a material of the hydraulic restriction device 10a, or in case some part of the hydraulic restriction device 10a distends as a result of material fatigue.
In an alternative embodiment, the injection port may be an integrated portion of the reservoir, such that for example a portion of the wall of the medical device may comprise the self-sealing membrane injection port membrane such that additional hydraulic fluid can be injected directly into the reservoir.
Turning again to the first and/or supporting operable hydraulic constriction elements 101a, 201. The supporting operable hydraulic constriction element 201 has a length 13 in the axial direction AD of the urinary bladder U, when implanted. The first operable hydraulic constriction element 101a has a length 12 in the axial direction AD of the urinary bladder U. In the embodiment shown in
In the embodiment shown in
In the embodiment of
In the embodiment shown in
In the embodiment shown in
In the embodiment shown in
One advantage of having the injection ports 108, 208 being directly in fluid connection with the first and supporting operable hydraulic constriction elements 101a, 201 is that the injection ports can be used as a safety system through which the hydraulic fluid can be removed from the first and supporting operable hydraulic constriction elements 101a, 201 in case there is a malfunction to the pumps 104, 204 of the electrically operable valves 105, 205. I.e. if there is a malfunction to the pumps 104, 204 or valves 105, 205, an injection needle can be inserted into the injection ports 108, 208 and fluid withdrawn from the first and supporting operable hydraulic constriction elements 101a, 201 such that the urinary bladder U is left unrestricted such that the patient can urinate even if the constriction device does not function.
The controller 300 is in the embodiment shown in
In the embodiment shown in
The surrounding structure 20 and the integrated channels shown in
That the first portion W1 of the connecting wall portion W is more resilient than the second portion W2 means that the second portion W2 is more rigid and less prone to change its size and/or location by external forces pushing on the operable hydraulic constriction element 101a. That the first portion W1 of the connecting wall portion W is more resilient than the second portion W2 further means that the first wall portion is more adaptable and follows the contours of the urinary bladder U better as the operable hydraulic constriction element 101a is inflated and deflated which reduces the risk that the urinary bladder is damaged by the contact with the operable hydraulic constriction element 101a. The combination of a more rigid second wall portion W2 and a more resilient first wall portion W1 creates an operable hydraulic constriction element 101a which is stable along the axial direction AD of the urinary bladder U, which means that the operable hydraulic constriction element 101a will retain its position along the axial direction AD of the urinary bladder U, such that the force exerted on the urinary bladder U in the first direction d1 is exerted on the first portion p1 of the urinary bladder U, while at the same time being resilient enough not to injure the urinary bladder U.
In the embodiment shown in
In the embodiment shown in
In the embodiment shown in
The varying resilience of the wall of the connecting wall means that the implantable operable hydraulic constriction element 101a will be more resilient closest to the urinary bladder U and more stable at a distance from the urinary bladder U. This will ensure that the implantable operable hydraulic constriction element 101a can maintain its shape even in its expanded state, in which the distance from the withholding structure 20 to the urinary bladder is relatively large, also when the pressure in the urinary bladder U presses on the implantable operable hydraulic constriction element 101a in the axial direction AD of the urinary bladder U. At the same time, the more resilient portions art of the connecting wall W, together with the more resilient contacting wall portion 102a ensures that the implantable operable hydraulic constriction element 101a does minimal harm to the urinary bladder U.
In alternative embodiments, the difference in resilience could come from the different portions of the connecting wall comprising different materials. In embodiments in which the different portions of the connecting wall comprise different materials, the different wall portions may have the same average wall thickness. It is also conceivable that the difference in resilience comes from a combination of wall thickness and material, i.e. portions of the connecting wall close to the urinary bladder may have both a lower average wall thickness and comprise a more resilient material and portions of the connecting wall further from the urinary bladder may have both a higher average wall thickness and comprise a less resilient material.
In one alternative embodiment, the first portion W1 of the connecting wall portion W may comprise a first material and the second portion W2 of the connecting wall portion W may comprise a second material, and wherein the first material has a lower modulus of elasticity than the first material. In the alternative embodiment, the modulus of elasticity of the first material is less than 0,8 times the modulus of elasticity of the second material, and in another embodiment the modulus of elasticity of the first material is less than 0,8 times the modulus of elasticity of the second material. In the alternative embodiment, the first material is a medical grade silicone material and the second material is a less elastic medical grade silicone material.
The first operable hydraulic constriction element 101a is configured to be placed at a first portion p1 of the urinary bladder U for constricting the first portion p1 of the urinary bladder U for restricting the flow of fluid therethrough, and the second operable hydraulic constriction element 101b is configured to be placed at a second portion p2 of the urinary bladder U, downstream the first portion p1, for constricting the second portion p2 of the urinary bladder U for restricting the flow of fluid therethrough and for evacuating urine from the urinary bladder U.
A first portion 109′ of the first reservoir conduit 109 is connected to the lumen 103a of the first operable hydraulic constriction element 101a and a second portion 109″ of the first reservoir conduit 109 is connected to the lumen 103b of the second operable hydraulic constriction element 101b. The first portion 109′ of the first reservoir conduit 109 is connected to the second portion 109″ of the first reservoir conduit 109 by means of a first interconnecting fluid conduit 116, and as such, the first operable hydraulic constriction element is in fluid connection with the second operable hydraulic constriction element. The fluid connection is configured to conduct fluid from the first operable hydraulic constriction element 101a to the second operable hydraulic constriction element 101b when the pressure increases in the first operable hydraulic constriction element 101a, such that second operable hydraulic constriction element constricts 101b the second portion p2 of the urinary bladder U further.
The first operable hydraulic constriction element 101a has a larger volume than the second operable hydraulic constriction element 101b, i.e. the lumen 103a of the first operable hydraulic constriction element 101a is larger than the lumen 103b of the second operable hydraulic constriction element 101b. This means that a compression of the first operable hydraulic constriction element 101a leads to a larger expansion of the first operable hydraulic constriction element 101a by the fluid connection 109′,109″,116. However, the second operable hydraulic constriction element 101b may have a larger volume than the first operable hydraulic constriction element 101a in other embodiments. The first operable hydraulic constriction element 101a may be configured to constrict the first portion p1 in order to close the urinary bladder U so that when the second operable hydraulic constriction element 101b is activated the urine will be pumped out of the urinary bladder U and not back into the urinary bladder U again.
The lumens 103a, 103b of the first and second operable hydraulic constriction elements 101a, 101b are divided by a resilient division wall 115, which in the embodiment of
In the embodiment shown in
The lumens 203a, 203b of the first and second supporting operable hydraulic constriction elements 201a, 201b are divided by a resilient division wall 215, which in the embodiment of
Similarly to
The first and second supporting operable hydraulic constriction elements 201a, 201b are connected to a second reservoir 207 though a supporting reservoir conduit 209. A second hydraulic pump 204 is provided on the supporting reservoir conduit 209 for moving fluid from the second reservoir 207 to the first and second supporting operable hydraulic constriction elements 201a, 201b.
In normal operation, the implantable pumping device 10 in the embodiment of
Depending on which type of pump it is, there may be a need to have electrically operable valve 105 connected in series with the hydraulic pump 104 to enable closure of the fluid communication between the first and second operable hydraulic constriction elements 101a, 101b and the first reservoir 107. However, in embodiments in which the hydraulic pump 104 is of a type that hinders leakage through the pump and/or hinders elasticity in the pump and/or reservoir 107, such as for example a peristaltic pump, the electrically operable valve 105 may be omitted.
In the embodiment shown in
The embodiment of
In the embodiment shown in
The embodiment shown in
The controller 300 further comprises an energy storage unit 40 which may be a battery, a chargeable battery or a capacitor by means of which energy can be stored in the body of the patient. The controller 300 further comprises an internal computing unit 306 for handling the control of the restriction device. The computing unit 306 could comprise a single central processing unit, or could comprise two or more processing units. The processing unit could comprise a general purpose microprocessor and/or an instruction set processor and/or related chips sets and/or special purpose microprocessors such as ASICs (Application Specific Integrated Circuit). The computing unit 306 comprises an internal memory configured to store programs thereon. The controller 300 could be adapted to keep track of the lapsed time with specific pressures such that the average and min/max pressures exerted by the implantable pumping device 10 can be logged. The controller 300 further comprises a transceiver 308 for receiving and/or transmitting wirelessly signals to/from outside the body. The transceiver 308 can enable programming the controller 300 form outside of body of the patient such that the implantable pumping device 10 can be programmed to function optimally. The optimal function of the implantable pumping device 10 could in many instances be a mediation between optimal restriction of the urinary bladder U and restriction with causes the least damage.
As an example, the controller 300 could comprise a pressure threshold value stored in memory, and be configured to open the electrically operable valve 105 to allow fluid o flow back to the reservoir 107 if the received pressure sensor signal from the first pressure sensor 106′ exceeds the pressure threshold value.
The controller 300 is enclosed by an enclosure such that the controller 300 is protected from bodily fluids. The enclosures may be an enclosure made from one of or a combination of: a carbon based material (such as graphite, silicon carbide, or a carbon fiber material), a boron material, a polymer material (such as silicone, Peek®, polyurethane, UHWPE or PTFE,), a metallic material (such as titanium, stainless steel, tantalum, platinum, niobium or aluminum), a ceramic material (such as zirconium dioxide, aluminum oxide or tungsten carbide) or glass. In any instance the enclosure should be made from a material with low permeability, such that migration of fluid through the walls of the enclosure is prevented.
In the embodiment of
In the embodiment of
The surrounding structure 20 comprises an inner surface 22 configured to face the urinary bladder U, when implanted. The supporting operable hydraulic constriction devices 201a, 201b is fixated to the inner surface 22 of the surrounding structure 20, such that the supporting operable hydraulic constriction devices 201a, 201b can use the surrounding structure 20 as support for constricting the urinary bladder U. In the embodiment shown in
In the embodiment shown in
In the embodiment shown in
The surrounding structure 20 and the integrated channels shown in
The first operable hydraulic constriction element 101a is configured to be inflated and thereby expand in a first direction d1 towards the urinary bladder U to constrict a portion of the urinary bladder U for restricting the flow of fluid therethrough. The first operable hydraulic constriction element 101a comprises a lumen 103a surrounded by a resilient wall 102 made from a biocompatible material such as a medical grade silicone or a medical grade polyurethane-based material.
In the embodiment shown in
The second support element 24b comprises a cushioning element 30 configured to contact the urinary bladder U. The cushioning element 30 is fixated to the inner surface of the second support element 24b by means of an adhesive and is more resilient than the second support element 24b. The cushioning element 30 is made from a soft medical grade silicone or polyurethane material.
All foreign matter implanted into the human body inevitably causes an inflammatory response. In short, the process starts with the implanted medical device immediately and spontaneously acquiring a layer of host proteins. The blood protein-modified surface enables cells to attach to the surface enabling monocytes and macrophages to interact on the surface of the medical implant. The macrophages secrete proteins that modulate fibrosis and in turn developing the fibrosis capsule around the foreign body. In practice, a fibrosis capsule is a dense layer of excess fibrous connective tissue. On a medical device implanted in the abdomen, the fibrotic capsule typically grows to a thickness of about 0.5 mm-2 mm, and is substantially inelastic and dense. In the embodiment of
In the embodiment of
The first support element 24a is configured to support a first operable hydraulic constriction element 101a and a supporting operable hydraulic constriction element 201a. The first and supporting operable hydraulic constriction element 101a, 201a are configured to constrict the urinary bladder U for restricting the flow of fluid therethrough and configured to release the constriction of the urinary bladder U. The first and second support elements 24a, 24b each comprises a curvature adapted for the curvature of the urinary bladder U such that the implantable pumping device 10 fits snuggly around the urinary bladder U such that the distance that the operable hydraulic constriction elements 101a, 201a needs to expand to constrict the urinary bladder U is kept at a minimum.
Both the first and supporting operable hydraulic constriction element 101a, 201a are configured to be inflated and thereby expand in a first direction d1 towards the urinary bladder U to constrict a portion of the urinary bladder U for restricting the flow of fluid therethrough. The first operable hydraulic constriction element 101a comprises a lumen 103a surrounded by a resilient wall 102 made from a biocompatible material such as a medical grade silicone or a medical grade polyurethane-based material. The supporting operable hydraulic constriction element 201a comprises a lumen 203a surrounded by a resilient wall 202 made from a biocompatible material such as a medical grade silicone or a medical grade polyurethane-based material. The supporting operable hydraulic constriction element 201a is placed between the first operable hydraulic constriction element 101a and the support element 24a.
In the embodiment shown in
In the embodiment shown in
The portions of the wall 202 of the supporting operable hydraulic constriction element 201a could be made from the same material as the rest of the wall of the supporting operable hydraulic constriction element 201a or could in the alternative be made from a second different, more rigid material. The second material could have a modulus of elasticity which is higher than a modulus of elasticity of the first material. As an example, the first material could be a medical grade silicone material, and the second material could be another, less elastic medical grade silicone. According to one embodiment, the modulus of elasticity of the second material is more than 1,5 times higher than the modulus of elasticity of the first material. According to another embodiment, the modulus of elasticity of the second material is more than 2 times higher than the modulus of elasticity of the first material.
The supporting operable hydraulic constriction element 201a is connected to a second hydraulic fluid conduit 209 which enters the supporting operable hydraulic constriction element 201 through a second integrated channel 23b in the first support element 24a. The first and second fluid conduits 109, 209, and thereby the operable hydraulic constriction elements 101a, 201a, are connected to a hydraulic pump and control system (not shown), such as any the hydraulic pump and control systems disclosed with reference to
It is important to note that although the implantable energized medical device is disclosed herein as having a third cross-sectional area being smaller than a first cross-sectional area, this feature is not essential. The third cross-sectional area may be equal to or larger than the first cross-sectional area.
The connecting portion 142 thus has a portion being sized and shaped to fit through the hole in the tissue portion 610, such portion having the third cross-sectional area A3. Furthermore, the connecting portion 142 may have another portion being sized and shaped to not fit through the hole in the tissue portion 610, such portion having the fourth cross-sectional area A4. Likewise, the second portion 141″ may have a portion being sized and shaped to not fit through the hole in the tissue portion 610, such portion having the second cross-sectional area A2. Thus, the connecting portion 142 may cooperate with the second portion 141″ to keep the device in place in the hole of the tissue portion 610.
In the embodiment illustrated in
The device 140 is configured such that, when implanted, the first portion 141′ will be placed closer to an outside of the patient than the second portion 141″. Furthermore, in some implantation procedures the device 140 may be implanted such that space will be available beyond the second portion, i.e. beyond the second side 618 of the tissue portion 610, whereas there may not be as much space on the first side 612 of the tissue portion. Furthermore, tissue and/or skin may exert a force on the first portion 141″ towards the tissue portion 610, and provide for that the second portion 141″ does not travel through the hole in the tissue portion towards the first side 612 of the tissue portion. Thus, it is preferably if the device 140 is primarily configured to prevent the first portion 141″ from travelling through the hole in the tissue portion 612 towards the second side 618 of the tissue portion 610.
The first portion 141′ may further comprise one or several connections 605 for transferring energy and/or communication signals to the second portion 141″ via the connecting portion 142. The connections 605 in the illustrated embodiment are symmetrically arranged around a circumference of a protrusion 607 of the first portion 141′ and are arranged to engage with a corresponding connection 609 arranged at an inner surface of the connecting portion 142. The protrusion 607 may extend in a central extension C1 of the central portion 142. The second portion 141″ may also comprise one or several connections 611, which may be similarly arranged and configured as the connections 605 of the first portion 141′. For example, the one or several connections 611 may engage with the connection 609 of the connecting portion 142 to receive energy and/or communication signals from the first portion 141′. Although the protrusion 607 is illustrated separately in
Other arrangements of connections are envisioned, such as asymmetrically arranged connections around the circumference of the protrusion 607. It is also envisioned that one or several connections may be arranged on the first surface 614 of the first portion 141′, wherein the connections are arranged to engage with corresponding connections arranged on the opposing surface 613 of the connecting portion. Such connections on the opposing surface 613 may cover a relatively large area as compared to the connection 609, thus allowing a larger area of contact and a higher rate and/or signal strength of energy and/or communication signal transfer. Furthermore, it is envisioned that a physical connection between the first portion 141′, connecting portion 142 and second portion 141″ may be replaced or accompanied by a wireless arrangement, as described further in other parts of the present disclosure.
Any of the first surface 614 of the first portion 141′, the second surface 620 of the second portion 141′, the third surface 624 of the connecting portion 142, and an opposing surface 613 of the connecting portion 142, may be provided with at least one of ribs, barbs, hooks, a friction enhancing surface treatment, and a friction enhancing material, to facilitate the device 140 being held in position by the tissue portion, and/or to facilitate that the different parts of the device are held in mutual position.
The opposing surface 613 of the connecting portion 142 and the first surface 614 of the first portion 141′ may provide, fully or partly, a connection mechanism to detachably connect the first portion 141′ to the connecting portion 142. Such connection mechanisms have been described previously in the presented disclosure, and can be arranged on one or both of the opposing surface 613 and the first surface 614, and will not be further described here.
The opposing surface 613 may be provided with a recess configured to house at least part of the first portion 141′. In particular, such recess may be configured to receive at least a portion of the first portion 141′, including the first surface 614. Similarly, the first surface 614 may be provided with a recess configured to house at least part of the connecting portion 142. In particular, such recess may be configured to receive at least a portion of the connecting portion 142, and in some embodiments such recess may be configured to receive at least one protruding element to at least partially enclose at least one protruding element or flange.
In the illustrated embodiment, the first portion 141′ comprises a first energy storage unit 304a and a controller 300a comprising one or several processing units connected to the first energy storage unit 304a. The first energy storage unit 304a may be rechargeable by wireless transfer of energy. In some embodiments, the first energy storage unit 304a may be non-rechargeable. Upon reaching the life-time end of such first energy storage, a replacement first portion comprising a new first energy storage unit may simply be swapped in place for the first portion having the depleted first energy storage unit. The second portion 141″ may further comprise a controller 300b comprising one or several processing units.
As will be described in other parts of the present disclosure, the first portion 141′ and the second portion 141″ may comprise one or several functional parts, such as receivers, transmitters, transceivers, control units, processing units, sensors, energy storage units, sensors, etc.
The device 140 may be non-inflatable.
The second portion 141″ in the illustrated embodiment comprises a pump as described in conjunction with
The first portion 141′ may be detachably connected to at least one of the connecting portion 142 and the second portion 141″.
As can be seen in
It is to be understood that the illustrated planes P1, P2, P3 and P4 are merely an example of how such planes may intersect the device 140. Other arrangements of planes are possible, as long as the conditions above are fulfilled, i.e. that the portions have cross-sectional areas, wherein the third cross-sectional area in the third plane P3 is smaller than the first, second and fourth cross-sectional areas, and that the planes P1, P2, P3 and P4 are parallel to each other.
The connecting portion 142 illustrated in
The connecting portion 142 is not restricted to flanges, however. Other protruding elements may additionally or alternatively be incorporated into the connecting portion 142. As such, the connecting portion 142 may comprise at least one protruding element comprising the fourth cross-sectional area A4, such that the at least one protruding element is prevented from travelling through the hole in the tissue portion 610, such that the second portion 141″ and the connecting portion 142 can be held in position by the tissue portion 610 of the patient also when the first portion 141′ is disconnected from the connecting portion 142. The at least one protruding element may protrude in a direction parallel to the first, second, third and fourth planes P1, P2, P3 and P4. This direction is perpendicular to a central extension C1 of the connecting portion 142. As such, the at least one protruding element will also comprise the third surface configured to engage the first tissue surface 616 of the first side 612 of the tissue portion 610.
The connecting portion 142 may comprise a hollow portion 628. The hollow portion 628 may provide a passage between the first and second portions 141′, 141″. In particular, the hollow portion 628 may house a conduit for transferring fluid from the first portion 141′ to the second portion 141″. The hollow portion 628 may also comprise or house one or several connections or electrical leads for transferring energy and/or communication signals between the first portion 141′ and the second portion 141″.
Some relative dimensions of the device 140 will now be described with reference to
The height H1 of the first portion 141′ in a direction perpendicular to the first plane may be less than a height H2 of the second portion 141″ in said direction, such as less than half of said height H2 of the second portion 141″ in said direction, less than a quarter of said height H2 of the second portion 141″ in said direction, or less than a tenth of said height H2 of the second portion 141″ in said direction.
The at least one protruding element 626 may have a diameter DF in the fourth plane being one of less than a diameter D1 of the first portion 141′ in the first plane, equal to a diameter D1 of the first portion 141′ in the first plane, and larger than a diameter D1 of the first portion 141′ in the first plane. Similarly, the cross-sectional area of the at least one protruding element 626 in the fourth plane may be less, equal to, or larger than a cross-sectional area of the first portion in the first plane.
The at least one protruding element 626 may have a height HF in a direction perpendicular to the fourth plane being less than a height HC of the connecting portion 142 in said direction. Here, the height HC of the connecting portion 142 is defined as the height excluding the at least one protruding element, which forms part of the connecting portion 142. The height HF may alternatively be less than half of said height HC of the connecting portion 142 in said direction, less than a quarter of said height HC of the connecting portion 142 in said direction, or less than a tenth of said height HC of connecting portion 142 in said direction.
As shown in
As shown in
As shown in
The at least two protruding elements 626, 627 may be symmetrically arranged about the central axis of the connecting portion, as shown in
The first portion 141′ may comprise a first energy storage unit for supplying the device 140 with energy.
Although one type or embodiment of the implantable energized medical device 140, which may be referred to as a remote unit in other parts of the present disclosure, may fit most patients, it may be necessary to provide a selection of implantable energized medical devices 140 or portions to be assembled into implantable energized medical devices 140. For example, some patients may require different lengths, shapes, sizes, widths or heights depending on individual anatomy. Furthermore, some parts or portions of the implantable energized medical device 140 may be common among several different types or embodiments of implantable energized medical devices, while other parts or portions may be replaceable or interchangeable. Such parts or portions may include energy storage devices, communication devices, fluid connections, mechanical connections, electrical connections, and so on.
To provide flexibility and increase user friendliness, a kit of parts may be provided. The kit preferably comprises a group of one or more first portions, a group of one or more second portions, and a group of one or more connecting portions, the first portions, second portions and connecting portions being embodied as described throughout the present disclosure. At least one of the groups comprises at least two different types of said respective portions. By the term “type”, it is hereby meant a variety, class or embodiment of said respective portion.
In some embodiments of the kit, the group of one or more first portions, the group of one or more second portions, and the group of one or more connecting portions, comprise separate parts which may be assembled into a complete implantable energized medical device. The implantable energized medical device may thus be said to be modular, in that the first portion, the second portion, and/or the connecting portion may be interchanged for another type of the respective portion.
In some embodiments, the connecting portion form part of the first portion or the second portion.
With reference to
Accordingly, the group 652 of one or more connecting portions 142 comprise three different types of connecting portions 142. Here, the different types of connecting portions 142 comprise connecting portions 142a, 142b, 142c having different heights. Furthermore, the group 654 of one or more second portions 141″ comprise two different types of second portions 141″.
Here, the different types of second portions 141″ comprise a second portion 141″a being configured to excentrically connect to a connecting portion, having a first end and a second end as described in other parts of the present disclosure, wherein the second end of the second portion 141″a comprises or is configured for at least one connection for connecting to an implant being located in a caudal direction from a location of the implantable energized medical device in the patient, when the device is assembled. In the illustrated figure, the at least one connection is visualized as a lead or wire. However, other embodiments are possible, including the second end comprising a port, connector or other type of connective element for transmission of power, fluid, and/or signals.
Furthermore, the different types of second portions 141″ comprise a second portion 141″b being configured to excentrically connect to a connecting portion, having a first end and a second end as described in other parts of the present disclosure, wherein the first end of the second portion 141″b comprises or is configured for at least one connection for connecting to an implant being located in a cranial direction from a location of the implantable energized medical device in the patient, when the device is assembled. In the illustrated figure, the at least one connection is visualized as a lead or wire. However, other embodiments are possible, including the first end comprising a port, connector or other type of connective element for transmission of power, fluid, and/or signals.
Thus, the implantable energized medical device may be modular, and different types of devices can be achieved by selecting and combining a first portion 141′, a connecting portion 142, and a second portion 141″, from each of the groups 652, 654, 656.
In the illustrated example, a first implantable energized medical device 140a is achieved by a selection of the first portion 141′, the connecting portion 142a, and the second portion 141″a. Such device 140a may be particularly advantageous in that the connecting portion 142a may be able to extend through a thick layer of tissue to connect the first portion 141′ and the second portion 141″a. Another implantable energized medical device 140b is achieved by a selection of the first portion 141′, the connecting portion 142c, and the second portion 141″b. Such device may be particularly advantageous in that the connecting portion 142c has a smaller footprint than the connecting portion 142a, i.e. occupying less space in the patient. Owing to the modular property of the devices 140a and 140b, a practician or surgeon may select a suitable connecting portion as needed upon having assessed the anatomy of a patient. Furthermore, since devices 140a and 140b share a common type of first portions 141′, it will not be necessary for a practician or surgeon to maintain a stock of different first portions (or a stock of complete, assembled devices) merely for the sake of achieving a device having different connections located in the first end or second end of the second portion respectively, as in the case of second portions 141″a, 141″b.
The example illustrated in
With reference to
Although receivers and transmitters may be discussed and illustrated separately in the present disclosure, it is to be understood that the receivers and/or transmitters may be comprised in a transceiver. Furthermore, the receivers and/or transmitters in the first portion 141′ and second portion 141″ respectively may form part of a single receiving or transmitting unit configured for receiving or transmitting energy and/or communication signals, including data. Furthermore, the internal wireless energy transmitter and/or a first wireless communication receiver/transmitter may be a separate unit 308c located in a lower portion of the first portion 141′, referred to as a proximal end of the first portion 141′ in other parts of the present disclosure, close to the connecting portion 142 and the second portion 141″. Such placement may provide for that energy and/or communication signals transmitted by the unit 308c will not be attenuated by internal components of the first portion 141′ when being transmitted to the second portion 141″. Such internal components may include a first energy storage unit 304a.
The first portion 141′ here comprises a first energy storage unit 304a connected to the first wireless energy receiver 308a. The second portion comprises a second energy storage unit 304b connected to the second wireless energy receiver 308b. Such an energy storage unit may be a solid-state battery, such as a thionyl-chloride battery.
In some embodiments, the first wireless energy receiver 308a is configured to receive energy transmitted wirelessly by the external wireless energy transmitter and store the received energy in the first energy storage unit 304a. Furthermore, the internal wireless energy transmitter 308a is configured to wirelessly transmit energy stored in the first energy storage unit 304a to the second wireless energy receiver 308b, and the second wireless energy receiver 308b is configured to receive energy transmitted wirelessly by the internal wireless energy transmitter 308a and store the received energy in the second energy storage unit 305b.
The first energy storage unit 304a may be configured to store less energy than the second energy storage unit 304b, and/or configured to be charged faster than the second energy storage unit 304b. Hereby, charging of the first energy storage unit 304a may be relatively quick, whereas transfer of energy from the first energy storage unit 304a to the second energy storage unit 304b may be relatively slow. Thus, a user can quickly charge the first energy storage unit 304a, and will not during such charging be restricted for a long period of time by being connected to an external wireless energy transmitter, e.g. at a particular location. After having charged the first energy storage unit 304a, the user may move freely while energy slowly transfers from the first energy storage unit 304a to the second energy storage unit 304b, via the first wireless energy transmitter 308a,c and the second wireless energy receiver 308b.
The first portion may comprise a first controller comprising at least one processing unit 306a. The second portion may comprise a second controller comprising at least one processing unit 306b. At least one of the first and second processing unit 306a, 306b may be connected to a wireless transceiver 308a,b,c for communicating wirelessly with an external device.
The first controller may be connected to a first wireless communication receiver 308a,c in the first portion 141′ for receiving wireless communication from an external device and/or from a wireless communication transmitter 308b in the second portion 141″. Furthermore, the first controller may be connected to a first wireless communication transmitter 308a,c in the first portion 141′ for transmitting wireless communication to a second wireless communication receiver 308b in the second portion 141″. The second controller may be connected to the second wireless communication receiver 308b for receiving wireless communication from the first portion 141′. The second controller may further be connected to a second wireless communication transmitter 308b for transmitting wireless communication to the first portion 141′.
In some embodiments, the first wireless energy receiver 308a comprises a first coil, and the wireless energy transmitter 308a,c comprises a second coil, as shown in
The device may further comprising at least one sensor (not shown) for providing input to at least one of the first and second controller. Such sensor data may be transmitted to an external device via the first wireless communication transmitter 308a and/or the second wireless communication transmitter 308b. The sensor may be or comprise a sensor configured to sense a physical parameter of the device 140. The sensor may also be or comprise a sensor configured to sense at least one of a temperature of the device 140, a temperature of a body engaging portion, a parameter related to the power consumption of the device, a parameter related to the power consumption of a body engaging portion, a parameter related to a status of at least one of the first and second energy storage units 304a, 304b, such as a health status of at least one of the first and second energy storage units 304a, 304b, a parameter related to the wireless transfer of energy from a source external to the body of the patient, and a hydraulic pressure. By the term “health status” it is hereby meant a status indicating the current total capacity of the energy storage unit as compared to the total capacity of an unused energy storage unit. The sensor may also be or comprise a sensor configured to sense a physiological parameter of the patient, such as at least one of a parameter related to the patient swallowing, a local temperature, a systemic temperature, a blood saturation, a blood oxygenation, a blood pressure, a parameter related to an ischemia marker, or pH. The sensor configured to sense a parameter related to the patient swallowing may comprise at least one of a motility sensor, a sonic sensor, an optical sensor, and a strain sensor. The sensor configured to sense pH may be configured to sense the acidity in the stomach.
The sensor may be configured to sense a temperature of the device 140, to avoid excessive heating of tissue connected to the device during operation of the device, or during operation of an external implant using the device, or charging of an energy storage unit in the device 140. Excessive heating may also damage the device and/or the energy storage unit. Excessive heating may also be an indicator that something is wrong with the device and may be used for triggering an alarm function for alerting the patient or physician. The sensor may also be configured to sense a parameter related to the power consumption of the device 140 or the power consumption of an external implant being powered by the device 140, to avoid excessive power consumption which may drain and/or damage the energy storage unit of the device 140. Excessive power consumption may also be an indicator that something is wrong with the device 140 and may be used for triggering an alarm function for alerting the patient or physician.
With reference to
The first portion 141′ has an elongated shape in the illustrated embodiment of
As illustrated in
Similarly, a connecting interface between the connecting portion 142 and the first portion 141′ may be excentric with respect to the first portion 141′ in the first direction 631, and/or in the second direction 633.
The first portion 141′, connecting portion 142 and second portion 141″ may structurally form one integral unit. It is however also possible that the first portion 141′ and the connecting portion 142 structurally form one integral unit, while the second portion 141″ form a separate unit, or, that the second portion 141″ and the connecting portion 142 structurally form one integral unit, while the first portion 141′ form a separate unit.
Additionally, or alternatively, the second portion 141″ may comprise a removable and/or interchangeable portion 639. In some embodiments, the removable portion 639 may form part of a distal region which will be further described in other parts of the present disclosure. A removable portion may also form part of a proximal region. Thus, the second portion 141″ may comprise at least two removable portions, each being arranged at a respective end of the second portion 141″. The removable portion 639 may house, hold or comprise one or several functional parts of the device 140, such as gears, motors, connections, reservoirs, and the like as described in other parts of the present disclosure. An embodiment having such removable portion 639 will be able to be modified as necessary to circumstances of a particular patient.
In the case of the first portion 141′, connecting portion 142 and second portion 141″ structurally forming one integral unit, the excentric connecting interface between the connecting portion 142 and the second portion 141″, with respect to the second portion 141″, will provide for that the device 140 will be able to be inserted into the hole in the tissue portion. The device 140 may for example be inserted into the hole at an angle, similar to how a foot is inserted into a shoe, to allow most or all of the second portion 141″ to pass through the hole, before it is angled, rotated, and/or pivoted to allow any remaining portion of the second portion 141″ to pass through the hole and allow the device 140 to assume its intended position.
As illustrated in
With reference to
The second portion 141″ may be curved along its length. For example, one or both ends of the second portion 141″ may point in a direction being substantially different from the second plane P2, i.e. curving away from or towards the tissue portion when implanted. In some embodiments, the second portion 141″ curves within the second plane P2, exclusively or in combination with curving in other planes. The second portion 141″ may also be curved in more than one direction, i.e. along its length and along its width, the width extending in a direction perpendicular to the length.
The first and second ends 632, 634 of the second portion 141″ may comprise an elliptical point respectively. For example, the first and second ends 632, 634 may comprise a hemispherical end cap respectively. It is to be understood that also the first and second ends of the first portion 141′ may have such features.
The second portion 141″ may have at least one circular cross-section along the length between the first end 632 and second end 634, as illustrated in
In the following paragraphs, some features and properties of the second portion 141″ will be described. It is however to be understood that these features and properties may also apply to the first portion 141′.
The second portion 141″ has a proximal region 636, an intermediate region 638, and a distal region 640. The proximal region 636 extends from the first end 632 to an interface between the connecting portion 142 and the second portion 141″, the intermediate region 638 is defined by the connecting interface 630 between the connecting portion 142 and the second portion 141″, and the distal region 640 extends from the connecting interface 630 between the connecting portion 142 and the second portion 141″ to the second end 634. The proximal region 636 is shorter than the distal region 640 with respect to the length of the second portion, i.e. with respect to the length direction 631. Thus, a heel (the proximal region) and a toe (the distal region) is present in the second portion 141″.
The second surface 620, configured to engage with the second tissue surface 622 of the second side 618 of the tissue portion 610, is part of the proximal region 636 and the distal region 640. If a length of the second portion 141″ is defined as x, and the width of the second portion 141″ is defined as y along respective length and width directions 631, 633 being perpendicular to each other and substantially parallel to the second plane P2, the connecting interface between the connecting portion 142 and the second portion 141″ is contained within a region extending from x>0 to x<x/2 and/or y>0 to y<y/2, x and y and 0 being respective end points of the second portion 141″ along said length and width directions. In other words, the connecting interface between the connecting portion 142 and the second portion 141″ is excentric in at least one direction with respect to the second portion 141″, such that a heel and a toe is formed in the second portion 141″.
The first surface 614 configured to face and/or engage the first tissue surface 616 of the first side 612 of the tissue portion 610 may be substantially flat. In other words, the first portion 141′ may comprise a substantially flat side facing towards the tissue portion 610. Furthermore, an opposing surface of the first portion 141′, facing away from the tissue portion 610, may be substantially flat. Similarly, the second surface 620 configured to engage the second tissue surface 622 of the second side 618 of the tissue portion 610 may be substantially flat. In other words, the second portion 141″ may comprise a substantially flat side facing towards the tissue portion 610. Furthermore, an opposing surface of the second portion 141″, facing away from the tissue portion 610, may be substantially flat.
The second portion 141″ may be tapered from the first end 632 to the second end 634, thus giving the second portion 141″ different heights and/or widths along the length of the second portion 141″. The second portion may also be tapered from each of the first end 632 and second end 634 towards the intermediate region 638 of the second portion 141″.
Some dimensions of the first portion 141′, the second portion 141″ and the connecting portion 142 will now be disclosed. Any of the following disclosures of numerical intervals may include or exclude the end points of said intervals.
The first portion 141′ may have a maximum dimension being in the range of 10 to 60 mm, such as in the range of 10 to 40 mm such as in the range of 10 to 30 mm, such as in the range of 10 to 25 mm, such as in the range of 15 to 40 mm, such as in the range of 15 to 35 mm, such as in the range of 15 to 30 mm, such as in the range of 15 to 25 mm. By the term “maximum dimension” it is hereby meant the largest dimension in any direction.
The first portion 141′ may have a diameter being in the range of 10 to 60 mm, such as in the range of 10 to 40 mm such as in the range of 10 to 30 mm, such as in the range of 10 to 25 mm, such as in the range of 15 to 40 mm, such as in the range of 15 to 35 mm, such as in the range of 15 to 30 mm, such as in the range of 15 to 25 mm.
The connecting portion 142 may have a maximum dimension in the third plane P3 in the range of 2 to 20 mm, such as in the range of 2 to 15 mm, such as in the range of 2 to 10 mm, such as in the range of 5 to 10 mm, such as in the range of 8 to 20 mm, such as in the range of 8 to 15 mm, such as in the range of 8 to 10 mm.
The second portion 141″ may have a maximum dimension being in the range of 30 to 90 mm, such as in the range of 30 to 70 mm, such as in the range of 30 to 60 mm, such as in the range of 30 to 40 mm, such as in the range of 35 to 90 mm, such as in the range of 35 to 70 mm, such as in the range of 35 to 60 mm, such as in the range of 35 to 40 mm.
The first portion has a first height H1, and the second portion has a second height H2, both heights being in a direction perpendicular to the first and second planes P1, P2. The first height may be smaller than the second height. However, in the embodiments illustrated in
As illustrated in
The length 646 of the distal region 640 is preferably longer than the length 644 of the intermediate region 638, however, an equally long distal region 640 and intermediate region 638, or a shorter distal region 640 than the intermediate region 638, is also possible. The length 642 of the proximal region 636 may be shorter than, equal to, or longer than the length 644 of the intermediate region 638.
The length 644 of the intermediate region 638 is preferably less than half of the length of the second portion 141″, i.e. less than half of the combined length of the proximal region 636, the intermediate region 638, and the distal region 630. In some embodiments, the length 644 of the intermediate region 638 is less than a third of the length of the second portion 141″, such as less than a fourth, less than a fifth, or less than a tenth of the length of the second portion 141″.
The connecting portion may have one of an oval cross-section, an elongated cross-section, and a circular cross-section, in a plane parallel to the third plane P3. In particular, the connecting portion may have several different cross-sectional shapes along its length in the central extension C1.
In some embodiments the distal region 640 is configured to be directed downwards in a standing patient, i.e. in a caudal direction when the device 140 is implanted. As illustrated in
The different orientations of the second portion 141″ relative the first portion 141′ may be defined as the length direction of the second portion 141″ having a relation or angle with respect to a length direction of the first portion 141′. Such angle may be 15 degrees, 30, 45, 60, 75 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240, 255, 270, 285, 300, 315, 330, 345 or 360 degrees. In particular, the angle between the first portion 141′ and the second portion 141″ may be defined as an angle in the planes P1 and P2, or as an angle in a plane parallel to the tissue portion 610, when the device 140 is implanted. In the embodiment illustrated in
The second end 634 of the second portion 141″ may comprise one or several connections for connecting to an implant being located in a caudal direction from a location of the implantable energized medical device in the patient. Hereby, when the device 140 is implanted in a patient, preferably with the distal region 640 and second end 634 pointing downwards in a standing patient, the connections will be closer to the implant as the second end 634 will be pointing in the caudal direction whereas the first end 632 will be pointing in the cranial direction. It is also possible that the second end 634 of the second portion 141″ is configured for connecting to an implant, i.e. the second end 634 may comprise a port, connector or other type of connective element for transmission of power, fluid, and/or signals.
Likewise, the first end 632 of the second portion 141″ may comprise one or several connections for connecting to an implant being located in a cranial direction from a location of the implantable energized medical device in the patient. Hereby, when the device 140 is implanted in a patient, preferably with the distal region 640 and second end 634 pointing downwards in a standing patient, the connections will be closer to the implant as the first end 632 will be pointing in the cranial direction whereas the second end 634 will be pointing in the caudal direction. It is also possible that the first end 632 of the second portion 141″ is configured for connecting to an implant, i.e. the first end 632 may comprise a port, connector or other type of connective element for transmission of power, fluid, and/or signals.
Wireless energy receivers and/or communication receivers and/or transmitters in the first portion 141′ may be configured to receive energy from and/or communicate wirelessly with an external device outside the body using electromagnetic waves at a frequency below 100 kHz, or more specifically below 40 kHz, or more specifically below 20 kHz. The wireless energy receivers and/or communication receivers and/or transmitters in the first portion 141′ may thus be configured to communicate with the external device using “Very Low Frequency” communication (VLF). VLF signals have the ability to penetrate a titanium housing of the implantable energized medical device, such that the electronics of the implantable medical device can be completely encapsulated in a titanium housing. In addition, or alternatively, communication and energy transfer between the first portion 141′ and second portion 141″ may be made using VLF signals. In such embodiments, receivers and transmitters (for energy and/or communication) of the first portion 141′ and second portion 141″ are configured accordingly.
Referring now to
With reference to
With reference to
Preferably, the first and second element 712, 714 are interconnected and formed such that a transition between the first and second element 712, 714 along the first direction 631 is flush. Furthermore, while in the first state, the first portion 141′ may possess the same feature as discussed in conjunction with
With reference to
With reference to
With reference to
With reference to
With reference to
With reference to
The rotational displacement of the first portion 141′ and the second portion 141″ forms a cross-like structure, being particularly advantageous in that insertion through the hole in the tissue portion 610 may be facilitated, and once positioned in the hole in the tissue portion 610 a secure position may be achieved. In particular, if the device 140 is positioned such that the second portion 141″ has its first cross-sectional distance CD1b extending along a length extension of the hole 611 in the tissue portion 610, insertion of the second potion 141″ through the hole 611 may be facilitated. Furthermore, if the first portion 141′ is then displaced in relation to the second portion 141″ such that the first cross-sectional distance CD la of the first portion 141′ is displaced in relation to a length extension of the hole 611, the first portion 141′ may be prevented from travelling through the hole 611 in the tissue portion. In these cases, it is particularly advantageous if the hole 611 in the tissue portion is oblong, ellipsoidal, or at least has one dimension in one direction being longer than a dimension in another direction. Such oblong holes in a tissue portion may be formed for example in tissue having a fiber direction, where the longest dimension of the hole may be aligned with the fiber direction.
In the embodiment illustrated in
As shown in
With reference to
One and the same device 140 may be capable of assuming several different arrangements with regards to rotational displacement of the first portion 141′ and the second portion 141″. In particular, this is possible when the first portion 141′ and/or the second portion 141″ is configured to detachably connect to the interconnecting portion 142. For example, a connection mechanism between the first portion 141′ and the connecting portion 142, or between the second portion 141″ and the connecting portion 142, may posses a rotational symmetry to allow the first portion 141′ to be set in different positions in relation to the connecting portion 142 and in extension also in relation to the second portion 141″. Likewise, such rotational symmetry may allow the second portion 142″ to be set in different positions in relation to the connecting portion 142 and in extension also in relation to the first portion 141′.
With reference to
With reference to
At least one of the first portion and the second portion comprises at least one coil embedded in a ceramic material, the at least one coil being configured for at least one of: receiving energy transmitted wirelessly, transmitting energy wirelessly, receiving wireless communication, and transmitting wireless communication. In the illustrated embodiment, the first portion 141′ comprises a first coil 658 and a second coil 660, and the second portion 141″ comprises a third coil 662. The coils are embedded in a ceramic material 664
As discussed in other part of the present disclosure, the first portion 141′ may comprise a first wireless energy receiver configured to receive energy transmitted wirelessly from an external wireless energy transmitter, and further the first portion 141′ may comprise a first wireless communication receiver. The first wireless energy receiver and the first wireless communication receiver may comprise the first coil. Accordingly, the first coil may be configured to receive energy wirelessly, and/or to receive communication wirelessly.
By the expression “the receiver/transmitter comprising the coil” it is to be understood that said coil may form part of the receiver/transmitter.
The first portion 141′ comprises a distal end 665 and a proximal end 666, here defined with respect to the connecting portion 142. In particular, the proximal end 665 is arranged closer to the connecting portion 142 and closer to the second portion 141″ when the device 140 is assembled. In the illustrated embodiment, the first coil 658 is arranged at the distal end 665.
The first portion 141′ may comprise an internal wireless energy transmitter, and further a first wireless communication transmitter. In some embodiments, the internal wireless energy transmitter and/or the first wireless communication transmitter comprises the first coil 658. However, in some embodiments the internal wireless energy transmitter and/or the first wireless communication transmitter comprises the second coil 660. The second coil 660 is here arranged at the proximal end 665 of the first portion 141′. Such placement of the second coil 660 may provide for that energy and/or communication signals transmitted by the second coil 660 will not be attenuated by internal components of the first portion 141′ when being transmitted to the second portion 141″.
In some embodiments, the first wireless energy receiver and the internal wireless energy transmitter comprises a single coil embedded in a ceramic material. Accordingly, a single coil may be configured for receiving energy wirelessly and for transmitting energy wirelessly. Similarly, the first wireless communication receiver and the first wireless communication transmitter may comprise a single coil embedded in a ceramic material. Even further, in some embodiments a single coil may be configured for receiving and transmitting energy wirelessly, and for receiving and transmitting communication signals wirelessly.
The coils discussed herein are preferably arranged in a plane extending substantially parallel to the tissue portion 610.
The second portion 141″ may comprise a second wireless energy receiver, and/or a second wireless communication receiver. In some embodiments, the third coil 662 in the second portion 141″ comprises the second wireless energy receiver and/or the second wireless communication receiver.
The second portion 141″ comprises a distal end 668 and a proximal end 670, here defined with respect to the connecting portion 142. In particular, the proximal end 668 is arranged closer to the connecting portion 142 and closer to the first portion 141′ when the device 140 is assembled. In the illustrated embodiment, the third coil 662 is arranged at the proximal end 668 of the second portion 141″. Such placement of the third coil 662 may provide for that energy and/or communication signals received by the third coil 662 will not be attenuated by internal components of the second portion 141″ when being received from the first portion 141′.
The first portion 141′ may comprise a first controller 300a connected to the first coil 658, second coil 660, and/or third coil 662. The second portion 141″ may comprise a second controller 300b connected to the first coil, 658, second coil 660, and/or third coil 662.
In the illustrated embodiment, the first portion 141′ comprises a first energy storage unit 304a connected to the first wireless energy receiver 308a, i.e. the first coil 658. The second portion comprises a second energy storage unit 304b connected to the second wireless energy receiver 308b, i.e. the third coil 662. Such an energy storage unit may be a solid-state battery, such as a thionyl-chloride battery.
In some embodiments, the first coil 658 is configured to receive energy transmitted wirelessly by the external wireless energy transmitter and store the received energy in the first energy storage unit 304a. Furthermore, the first coil 658 and/or the second coil 660 may be configured to wirelessly transmit energy stored in the first energy storage unit 304a to the third coil 662, and the third coil 662 may be configured to receive energy transmitted wirelessly by the first coil 658 and/or the second coil 660 and store the received energy in the second energy storage unit 305b.
The first energy storage unit 304a may be configured to store less energy than the second energy storage unit 304b, and/or configured to be charged faster than the second energy storage unit 304b. Hereby, charging of the first energy storage unit 304a may be relatively quick, whereas transfer of energy from the first energy storage unit 304a to the second energy storage unit 304b may be relatively slow. Thus, a user can quickly charge the first energy storage unit 304a, and will not during such charging be restricted for a long period of time by being connected to an external wireless energy transmitter, e.g. at a particular location. After having charged the first energy storage unit 304a, the user may move freely while energy slowly transfers from the first energy storage unit 304a to the second energy storage unit 304b, via the first and/or second coil and the third coil.
The housing 484 of the device or second portion 141″ may be present in some embodiments of the device. In such embodiments, the housing 484 is configured to enclose, at least, the controller (not shown), motor M, any receivers and transmitters if present (not shown), and any gear arrangements G, G1, G2 if present. Hereby, such features are protected from bodily fluids. The housing 484 may be an enclosure made from one of or a combination of: a carbon based material (such as graphite, silicon carbide, or a carbon fiber material), a boron material, a polymer material (such as silicone, Peek®, polyurethane, UHWPE or PTFE,), a metallic material (such as titanium, stainless steel, tantalum, platinum, niobium or aluminum), a ceramic material (such as zirconium dioxide, aluminum oxide or tungsten carbide) or glass. In any instance the enclosure should be made from a material with low permeability, such that migration of fluid through the walls of the enclosure is prevented.
The implantable energized medical device may comprise at least part of a magnetic coupling, such as a magnetic coupling part 490a. A complementary part of the magnetic coupling, such as magnetic coupling part 490b, may be arranged adjacent to the device 140, so as to magnetically couple to the magnetic coupling part 490a and form the magnetic coupling. The magnetic coupling part 490b may form part of an entity not forming part of the device 140. However, in some embodiments the second portion 141″ comprises several chambers being hermetically sealed from each other. Such chambers may be coupled via a magnetic coupling as discussed herein. The magnetic coupling 490a, 490b provide for that mechanical work output by the device 140 via e.g. an electric motor can be transferred from the device to e.g. an implant (or element) configured to exert force on a body part of a patient. In other words, the magnetic coupling 490a, 490b provides for that mechanical force can be transferred through the housing 484.
The coupling between components, such as between a motor and gear arrangement, or between a gear arrangement and a magnetic coupling, may be achieved by e.g. a shaft or the like.
In some embodiments, for example as illustrated in
In some embodiments, for example as illustrated in
In the embodiment shown in
In the embodiment of
The abdominal wall AW is most locations generally formed by a set of layers of skin, fat/fascia, muscles and the peritoneum. The deepest layer in the abdominal wall AW is the peritoneum PT, which covers many of the abdominal organs, for example the large and small intestines. The peritoneum PT is a serous membrane composed of a layer of mesothelium supported by a thin layer of connective tissue and serves as a conduit for abdominal organ's blood vessels, lymphatic vessels, and nerves. The area of the abdomen enclosed by the peritoneum PT is called the intraperitoneal space. The tissue and organs within the intraperitoneal space are called “intraperitoneal” (e.g., the stomach and intestines). The tissue and organs in the abdominal cavity that are located behind the intraperitoneal space are called “retroperitoneal” (e.g., the kidneys), and tissue and organs located below the intraperitoneal space are called “subperitoneal” or “infraperitoneal” (e.g., the bladder).
The peritoneum PT is connected to a layer of extraperitoneal fat EF which is connected to a layer or transversalis fascia TF. Connected to the transversalis fascia TF, at the area of the abdominal wall AW at which the section is extracted, is muscle tissue MT separated by layers of deep fascia DF. The deep fascia DF between the layers of muscle is thinner than the transversalis fascia TF and the Scarpa's fascia SF placed on the outside of the muscle tissue MT. Both the transversalis fascia TF and the Scarpa's fascia SF are relatively firm membranous sheets. At the area of the abdominal wall AW at which the section is extracted, the muscle tissue MT is composed of the transverse abdominal muscle TM (transversus abdominis), the internal oblique muscle IM (obliquus internus) and the external oblique muscle EM (obliquus externus). In other areas of the abdominal wall AW, the muscle tissue could also be composed of the rectus abdominis and the pyramidalis muscle.
The layer outside of the muscle tissue MT, beneath the skin SK of the patient is called subcutaneous tissue ST, also called the hypodermis, hypoderm, subcutis or superficial fascia. The main portion of the subcutaneous tissue ST is made up of Camper's fascia which consists primarily of loose connective tissue and fat. Generally, the subcutaneous tissue ST contains larger blood vessels and nerves than those found in the skin.
Placing the remote unit 140 at an area of the abdomen is advantageous as the intestines are easily displaced for making sufficient room for the remote unit 140, without the remote unit 140 affecting the patient too much in a sensational or visual way. Also, the placement of the remote unit 140 in the area of the abdomen makes it possible to fixate the remote unit 140 to the muscle tissue MT of the abdomen for creating an attachment keeping the remote unit 140 firmly in place. In the embodiment shown in
In the embodiment shown in
In the embodiment shown in
In alternative embodiments, it is furthermore conceivable that the first portion 141′ is placed in between layers of muscle, such as between tissue of external oblique muscle EM and the internal oblique muscle IM, or between the internal oblique muscle IM and the transverse abdominal muscle TM.
In embodiments in which the medical device exerting a force on a body part is hydraulically remotely operable (such as via a remote unit comprising a pump as further described with reference to
In the embodiment shown in
In the embodiment shown in
In the embodiment shown in
In alternative embodiments, it is furthermore conceivable that the first portion 141′ is placed in between layers of muscle, such as between tissue of external oblique muscle EM and the internal oblique muscle IM, or between the internal oblique muscle IM and the transverse abdominal muscle TM.
The deflectable hollow member 401 is connected to or integrated with fluid conduits 109′109″, which in turn are a part of the hydraulic system in any of the embodiments described herein. When the compression member 402 is propelled in a counterclockwise direction, it creates a peristaltic wave which presses hydraulic fluid through the hollow member 401 and further through the second portion of the fluid conduit 109″. When the compression member 402 is propelled in a clockwise direction, it creates a peristaltic wave which presses hydraulic fluid through the hollow member 401 and further through the first fluid conduit 109′. By using a peristaltic pump 104 of the embodiment of
The force output of the electrical motor M is in connection with a force input of a gear system G adapted to receive mechanical work having a first force and first velocity, and output mechanical work having a different second force and a different second velocity, such that the high velocity movement supplied by the electrical motor M is transformed to low velocity movement with increased force.
The gear system G may for example comprise a gear system having the configuration such as the gear system G described with reference to
The gear system G of
The controller 300, the energy storage unit 40 and the motor M and gear system G the may be enclosed by a housing 484 such that the controller 300 is protected from bodily fluids. The housing 484 may be an enclosure made from one of or a combination of: a carbon based material (such as graphite, silicon carbide, or a carbon fiber material), a boron material, a polymer material (such as silicone, Peek®, polyurethane, UHWPE or PTFE,), a metallic material (such as titanium, stainless steel, tantalum, platinum, niobium or aluminum), a ceramic material (such as zirconium dioxide, aluminum oxide or tungsten carbide) or glass. In any instance the enclosure should be made from a material with low permeability, such that migration of fluid through the walls of the enclosure is prevented.
Turning now to the hydraulic pump 104 shown in
The hydraulic pump 104 further comprises at least one bearing 482 for the shaft 481 placed between the gear system G and the compressible reservoir 107. The bearing 482 is configured to withhold at least half of the force in the axial direction, for reducing the axial load on the motor M and the gear system G which is caused by the compression of the reservoir 107. In the embodiment shown in
The gear system G is connected to the motor M, and placed between the motor M and transmission T and adapted to receive mechanical work via the shaft 481 having a force and a velocity, and output mechanical work having a stronger force and a lower velocity. The compressible reservoir 107 comprises a first resilient wall portion 102a and a second resilient wall portion 102b, wherein the first resilient wall portion 102a is more resilient than the second resilient wall portion 102b.
In alternative embodiments, the compression member 483 may be directly connected to the first resilient wall portion 102a, and in such embodiments, the threaded portion 483t may be integrated in the first resilient wall portion 102a.
In the embodiment shown in
The compressible reservoir 107 in the embodiment shown in
In the embodiment shown in
The hydraulic pump 104 of
The first disc shaped member 490a comprises magnets (or a material susceptible to magnetic fields) 491 evenly distributed axially in a circular formation on the distal surface of the first disc shaped member 490a.
The barrier 484′ separates the first chamber C1 of the housing 484 from the second chamber C2 of the housing. In the embodiment shown in
The second part of the magnetic coupling comprises a second disc shaped member 490b positioned in the second chamber C2 and held in place by a ball bearing 482b being fixated to the inside of the wall of the housing 484 enclosing the second chamber C2 by means of an internal wall portion 498. The second disc shaped member 490b comprises magnets (or a material susceptible to magnetic fields) 491b evenly distributed in a circular formation axially on the distal surface of the first disc shaped member 490b. The magnets 490b of the second disc shaped member 490b are configured to be magnetically connected to the magnets 491a of the first disc shaped member 490a such that the second disc shaped member 490b is dragged by the first disc shaped member 490a by means of the magnetic connection. As such, force from the motor M is transferred from the first hermetically enclosed chamber C1 to the second hermetically enclosed chamber C2.
The second disc shaped member 490b comprises a threaded shaft which is configured to be placed in and engage with a sleeve of a compression member 483. The sleeve of the compression member 483 comprises inside threads 483t for creating a transmission T that transforms the radially rotating force generated by the motor M and the gear system G, to a linear force acting in the axial direction of the shaft 481, and thus makes up a transmission T.
The compression member 483 is a disc shaped element having a distal surface engaging a first resilient wall portion 102a of the reservoir 107 for moving the first resilient wall portion 102a and thereby compressing the reservoir 107. The periphery of the compression member 483 comprises a flange 483f extending towards the first chamber C1 in the proximal direction creating a lateral surface area towards the housing 484. The lateral surface of the flange 483f is configured to engage the first resilient wall portion 102a for creating a rolling crease of the first resilient wall portion 102a. The disc shaped compression member 483 is rigid and made from titanium, just as the rest of the housing 484. That the compression member 483 is rigid makes the reservoir 107 stiff which ensures that the fluid amount in the hydraulic constriction element connected to the reservoir 107 remains the same even as the pressure exerted on the hydraulic constriction element increases.
The reservoir 107 is further enclosed by a second wall portion 102b which is a rigid titanium wall portion through which the conduit 109a enters the reservoir 107. Compression of the reservoir 107 thus forces the fluid from the reservoir through the conduit 109a. The housing 484 further comprises a transfer channel 478 creating a fluid connection between the second chamber C2 and a portion of the second chamber C2′ placed more distally. The transfer channel ensures that the pressure is the same in the second chamber C2 and distal portion of the second chamber C2′. The distal portion C2′ of the second chamber C2 comprises a expansion portion comprising a resilient membrane 495 configured to move to alter the volume of the distal portion C2′ of the second chamber C2 for compensating for the changes to the volume of the reservoir 107 which is created by the movement of the first resilient wall portion 102a of the reservoir 107. As such, the pressure in the second chamber C2 will be substantially constant. The resilient membrane 495 is in the embodiment shown in
The hydraulic pump of
A first portion 109′ of the fluid conduit is connected to an implantable hydraulic force transfer device 496 comprising a first chamber V1 configured to house a first fluid, and as such the first portion 109′ of the fluid conduit forms a fluid inlet into the first chamber V1. The first chamber V1 is in connection with a movable wall portion 497 for varying the size of the first chamber V1. The movable wall portion 497 is in turn connected to a second chamber V2 configured to house a second fluid. The second chamber comprises an outlet formed by a second portion 109″ of the fluid conduit. The second portion 109″ of the fluid conduit fluidly connects the second chamber C2 to the implantable hydraulic constriction element in any of the embodiments described herein, such that the implantable hydraulic constriction element can be operated for restricting and releasing the restriction of the urinary bladder. As such, the implantable hydraulic force transfer device 496 transfers hydraulic force from the hydraulic pump 104 to the implantable hydraulic constriction element without mixing the first and second fluids.
In the embodiment shown in
In the embodiment shown in
In alternative embodiments, the magnetic coupling described with reference to
Another difference between the embodiment shown in
The embodiment of
Another aspect of having the housings of any of the embodiments herein, is that the atmospheric pressure that the patient exists in may vary. At sea level, the air pressure is about 101 kPa, in a commercial airplane at cruising altitude, the air pressure is about 80 kPa which is about the same as in Mexico city, whereas in La Paz, the highest situated city, air pressure is only 62 kPa. This difference in air pressure affects any gaseous fluid, such as the air present in the chamber C1 in the embodiment of
In the embodiment shown in
Just as in
In alternative embodiments, the liquid filled first chamber C1 could be used in connection with another type of pump, i.e. the shaft 481 could be connected to another type of pump, such as the pumps described with reference to
The second coupling part 490b′ is connected to a rotatable shaft which is supported by roller bearings 482 being fixated to the inside of the wall of the housing 484. The rotatable shaft comprises a threaded portion which is configured to be placed in and engage with a sleeve of a compression member 483. The sleeve of the compression member 483 comprises inside threads 483t for creating a transmission T that transforms the radially rotating force generated by the motor M and the gear system G, to a linear force acting in the axial direction of the shaft 481, and thus makes up a transmission T.
In the embodiment shown in
In alternative embodiments, the first and second hydraulic pump mechanically connected to a common rotating shaft could be pump comprising at least one compressible hydraulic reservoir (such as the pump described with reference to
The embodiment of two pumps mechanically connected to a common rotating shaft, described with reference to
The pump system could further comprise pressure sensor(s) for sensing the pressure in the fluid flowing to and/or from the hydraulic pumps 460′, 460″. The sensor(s) could for example be sensors such as the sensors described with reference to
The pressure sensor 106 comprises a sensor housing 475 which comprises integrated channels. An inlet channel 470 is configured to conduct hydraulic fluid such that the hydraulic fluid is placed in contact with a diaphragm 471. The diaphragm 471 is resilient and could for example be made from a medical grade silicone material which is elastic enough such that the pressure exerted on the diaphragm 471 is transferred to a gel-like substance 473 which in turn presses on a pressure sensing element. The pressure sensing element is thus separated from the hydraulic fluid in the implantable pumping devices by the diaphragm 471. In the embodiment shown in
A resistive strain gauge uses a pressure sensing element 472 where metal strain gauges are fixated. The resistance through the metal strain gauges is changed with the elongation which is used to create the electrical pressure signal. A piezoresistive strain gauge uses the piezoresistive effect of strain gauges to detect strain due to applied pressure, resistance increasing as pressure deforms the material. Common technology types are Silicon (Monocrystalline), Polysilicon Thin Film, Bonded Metal Foil, Thick Film, Silicon-on-Sapphire and Sputtered Thin Film. A capacitive strain gauge uses the diaphragm 471 to create a variable capacitor to detect strain due to applied pressure as the capacitance decreases as pressure deforms the diaphragm 471. Common technologies use metal, ceramic, and silicon diaphragms. Electromagnetic strain gauges measures the displacement of the diaphragm 471 by means of changes in inductance (reluctance), LVDT, Hall Effect, or by eddy current principle. An optical strain gauge uses the physical change of an optical fiber to detect strain due to applied pressure. A common example of this type utilizes Fiber Bragg Gratings. The strain gauges may be connected to form a Wheatstone bridge circuit to maximize the output of the sensor and to reduce sensitivity to errors.
The pressure sensor, when implemented in any of the implantable pumping devices shown herein is ultimately configured to measure the pressure in the operable hydraulic constriction elements which exerts pressure on the urinary bladder for the purpose of evacuating urine from the urinary bladder. When a portion of the urinary bladder U is restricted, the blood flow of that particular portion of the urinary bladder is hampered, which creates a risk that the portion suffers from ischemia, which may cause irreversible necrosis of the restricted tissue. By measuring the pressure, the hydraulic pumps or electrically controllable valves of the system can be controlled to create optimal constriction of the urinary bladder which in many instances is a mediation between restriction of the urinary bladder such that no leakage occurs while making sure that the restriction does not damage the tissue of the urinary bladder.
The controller, such as for example the controller described with reference to
In alternative embodiments, the pressure sensor could be used for measuring the pressure of a gaseous fluid. In this case, the diaphragm is in connection with an enclosed lumen configured to hold a gaseous fluid, and the pressure sensing element is configured to sense the pressure of the gaseous fluid. The enclosed lumen configured to hold a gaseous fluid may then be in connection with a part of the hydraulic system holding the hydraulic fluid, such that the pressure in the hydraulic system (such as in a reservoir or in an operable hydraulic constriction element) can be measured indirectly by measuring the pressure of the gaseous fluid in the enclosed lumen.
In the following a detailed description of a method and apparatus for electrically stimulating the tissue of a luminary organ, for example a urinary bladder, for exercising the and thereby improve the conditions for long term implantation will be given. The electrical electrode arrangement described and the electrical electrodes comprised in the arrangement may be implemented in any of the embodiments of the implantable pumping device described herein for the purpose of exercising the tissue wall which is in contact with the constriction device. The body tends to react to a medical implant, partly because the implant is a foreign object, and partly because the implant interacts mechanically with tissue of the body. Exposing tissue to long-term engagement with, or pressure from, an implant may deprive the cells of oxygen and nutrients, which may lead to deterioration of the tissue, atrophy and eventually necrosis. The interaction between the implant and the tissue may also result in fibrosis, in which the implant becomes at least partially encapsulated in fibrous tissue. It is therefore desirable to stimulate or exercise the cells to stimulate blood flow and increase tolerance of the tissue for pressure from the implant.
Muscle tissue is generally formed of muscle cells that are joined together in tissue that can be either striated or smooth, depending on the presence or absence, respectively, of organized, regularly repeated arrangements of myofibrillar contractile proteins called myofilaments. Striated muscle tissue is further classified as either skeletal or cardiac muscle tissue. Skeletal muscle tissue is typically subject to conscious control and anchored by tendons to bone. Cardiac muscle tissue is typically found in the heart and not subject to voluntary control. A third type of muscle tissue is the so called smooth muscle tissue, which is typically neither striated in structure nor under voluntary control. Smooth muscle tissue can be found within the walls of organs and in for example the urinary bladder U.
The contraction of the muscle tissue may be activated both through the interaction of the nervous system as well as by hormones. The different muscle tissue types may vary in their response to neurotransmitters and endocrine substances depending on muscle type and the exact location of the muscle.
A nerve is an enclosed bundle of nerve fibers called axons, which are extensions of individual nerve cells or neurons. The axons are electrically excitable, due to maintenance of voltage gradients across their membranes, and provide a common pathway for the electrochemical nerve impulses called action potentials. An action potential is an all-or-nothing electrochemical pulse generated by the axon if the voltage across the membrane changes by a large enough amount over a short interval. The action potentials travel from one neuron to another by crossing a synapse, where the message is converted from electrical to chemical and then back to electrical.
The distal terminations of an axon are called axon terminals and comprise synaptic vesicles storing neurotransmitters. The axonal terminals are specialized to release the neurotransmitters into an interface or junction between the axon and the muscle cell. The released neurotransmitter binds to a receptor on the cell membrane of the muscle cell for a short period of time before it is dissociated and hydrolyzed by an enzyme located in the synapse. This enzyme quickly reduces the stimulus to the muscle, which allows the degree and timing of muscular contraction to be regulated delicately.
The action potential in a normal skeletal muscle cell is similar to the action potential in neurons and is typically about −90 mV. Upon activation, the intrinsic sodium/potassium channel of the cell membrane is opened, causing sodium to rush in and potassium to trickle out. As a result, the cell membrane reverses polarity and its voltage quickly jumps from the resting membrane potential of −90 mV to as high as +75 mV as sodium enters. The muscle action potential lasts roughly 2-4 ms, the absolute refractory period is roughly 1-3 ms, and the conduction velocity along the muscle is roughly 5 m/s. This change in polarity causes in turn the muscle cell to contract.
The contractile activity of smooth muscle cells is typically influenced by multiple inputs such as spontaneous electrical activity, neural and hormonal inputs, local changes in chemical composition, and stretch. This in contrast to the contractile activity of skeletal and cardiac muscle cells, which may rely on a single neural input. Some types of smooth muscle cells are able to generate their own action potentials spontaneously, which usually occur following a pacemaker potential or a slow wave potential. However, the rate and strength of the contractions can be modulated by external input from the autonomic nervous system. Autonomic neurons may comprise a series of axon-like swellings, called varicosities, forming motor units through the smooth muscle tissue. The varicosities comprise vesicles with neurotransmitters for transmitting the signal to the muscle cell.
The muscle cells described above, i.e., the cardiac, skeletal and smooth muscle cells are known to react to external stimuli, such as electrical stimuli applied by electrodes. A distinction can be made between stimulation transmitted by a nerve and direct electrical stimulation of the muscle tissue. In case of stimulation via a nerve, an electrical signal may be provided to the nerve at a location distant from the actual muscle tissue, or at the muscle tissue, depending on the accessibility and extension of the nerve in the body. In case of direct stimulation of the muscle tissue, the electrical signal may be provided to the muscle cells by an electrode arranged in direct or close contact with the cells. However, other tissue such as fibrous tissue and nerves may of course be present at the interface between the electrode and the muscle tissue, which may result in the other tissue being subject to the electrical stimulation as well.
In the context of the present application, the electrical stimulation discussed in connection with the various aspects and embodiments may be provided to the tissue in direct or indirect contact with the implantable pumping device. Preferably, the electrical stimulation is provided by one or several electrode elements arranged at the interface or contact surface between the implantable pumping device and the tissue. Thus, the electrical stimulation may, in terms of the present disclosure, be considered as a direct stimulation of the tissue. Particularly when contrasted to stimulation transmitted over a distance by a nerve, which may be referred to as an indirect stimulation or nerve stimulation.
Hence, an electrode arrangement comprising one or several electrode elements may be arranged in, partly in, on, or in close vicinity of the tissue that is to be exercised by means of an electrical signal. Preferably, the electrode may be arranged to transmit the electrical signal to the portions of the tissue that is affected, or risks to be affected, by mechanical forces exerted by the medical implant. Thus, the electrode element may be considered to be arranged between the implanted device and the tissue against which the device is arranged to rest when implanted.
During operation of the implantable pumping device, or the electrode arrangement, the electric signal may cause the muscle cells to contract and relax repeatedly. This action of the cells may be referred to as exercise and may have a positive impact in terms of preventing deterioration and damage of the tissue. Further, the exercise may help increasing tolerance of the tissue for pressure and mechanical forces generated by the medical implant.
The interaction between the implanted electrode element and the tissue of the luminary organ is to a large extent determined by the properties at the junction between the tissue and the electrode element. The active electrically conducting surface of the electrode element (in the following referred to as “metal”, even though other materials is equally conceivable) can either be uncoated resulting in a metal-tissue interface, or insulated with some type of dielectric material. The uncoated metal surface of the electrode element may also be referred to as a bare electrode. The interface between the electrode element and the tissue may influence the behavior of the electrode element, since the electrical interaction with the tissue is transmitted via this interface. In the biological medium surrounding the electrode element, such as the actual tissue and any electrolyte that may be present in the junction, the current is carried by charged ions, while in the material of the electrode element the current is carried by electrons. Thus, in order for a continuous current to flow, there needs to be some type of mechanism to transfer charge between these two carriers.
In some examples, the electrode element may be a bare electrode wherein the metal may be exposed to the surrounding biological medium when implanted in, or at the muscle tissue that is to be stimulated. In this case there may be a charge transfer at a metal-electrolyte interface between the electrode element and the tissue. Due to the natural strive for thermodynamic equilibrium between the metal and the electrolyte, a voltage may be established across the interface which in turn may cause an attraction and ordering of ions from the electrolyte. This layer of charged ions at the metal surface may be referred to as a “double layer” and may physically account for some of the electrode capacitance.
Hence, both capacitive faradaic processes may take place at the electrode element. In a faradaic process, a transfer of charged particles across the metal-electrolyte interface may be considered as the predominant current transfer mechanism. Thus, in a faradaic process, after applying a constant current, the electrode charge, voltage and composition tend to go to constant values. Instead, in a capacitive (non-faradaic) process charge is progressively stored at the metal surface and the current transfer is generally limited to the amount which can be passed by charging the interface.
In some examples, the electrode element may comprise a bare electrode portion, i.e., an electrode having an uncoated surface portion facing the tissue such that a conductor-tissue interface is provided between the electrode element and the tissue when the electrode element is implanted. This allows for the electric signal to be transmitted to the tissue by means of a predominantly faradaic charge transfer process. A bare electrode may be advantageous from a power consumption perspective, since a faradaic process tend to be more efficient than a capacitive charge transfer process. Hence, a bare electrode may be used to increase the current transferred to the tissue for a given power consumption.
In some examples, the electrode element may comprise a portion that is at least partly covered by a dielectric material so as to form a dielectric-tissue interface with the muscle tissue when the electrode is implanted. This type of electrode element allows for a predominantly capacitive, or non-faradaic, transfer of the electric signal to the muscle tissue. This may be advantageous over the predominantly faradaic process associated with bare electrodes, since faradaic charge transfer may be associated with several problems. Example of problems associated with faradaic charge transfer include undesirable chemical reactions such as metal oxidation, electrolysis of water, oxidation of saline, and oxidation of organics. Electrolysis of water may be damaging since it produces gases. Oxidation of saline can produce many different compounds, some of which are toxic. Oxidation of the metal may release metal ions and salts into the tissue which may be dangerous. Finally, oxidation of organics in a situation with an electrode element directly stimulating tissue may generate chemical products that are toxic.
These problems may be alleviated if the charge transfer by faradaic mechanisms is reduced, which may be achieved by using an electrode at least partly covered by a dielectric material. Preferably, the dielectric material is chosen to have as high capacitance as possible, restricting the currents flowing through the interface to a predominantly capacitive nature.
Several types of electrode elements can be combined with the present disclosure. The electrode element can for example be a plate electrode, comprising a plate-shaped active part forming the interface with the tissue. In other examples, the electrode may be a wire electrode, formed of a conducting wire that can be brought in electrical contact with the tissue. Further examples may include needle- or pin-shaped electrodes, having a point at the end which can be attached to or inserted in the muscle tissue. The electrodes may for example be encased in epoxy for electrical isolation and protection and comprise gold wires or contact pads for contacting the muscle tissue. Some of these examples of electrodes, methods of stimulating using electrodes, and how the electrode arrangements can be arranged in connection with implantable pumping devices will be discussed below with reference to
The stimulation controller 350 of
In the embodiment shown in
It will be appreciated that both faradaic and capacitive mechanisms may be present at the same time, irrespectively of the type of electrode used. Thus, capacitive charge transfer may be present also for a bare electrode forming a metal-tissue interface, and faradaic charge transfer may be present also for a coated electrode forming a dielectric-tissue interface. It has been found that the faradaic portion of the current delivered to the muscle tissue can be reduced or even eliminated by reducing the duration of the pulses of the electric signal. Reducing the pulse duration has turned out to be an efficient way of increasing the portion of the signal which can be passed through the interface as a capacitive current, rather than by a faradaic current. As a result, shorter pulses may produce less electrode and tissue damage.
The capacitive portion of the current may further be increased, relative to the faradaic portion, by reducing the amplitude of the current pulses of the electrical signal. Reducing the amplitude may reduce or suppress the chemical reactions at the interface between the electrode and the tissue, thereby reducing potential damage that may be caused by compounds and ions generated by such reactions.
In one example, the electrical stimulation may be controlled in such a manner that a positive pulse of the electrical signal is followed by a negative pulse (or, put differently, a pulse of a first polarity being followed by a pulse of a second, reversed polarity), preferably of the same amplitude and/or duration. Advantageously, the subsequent negative (or reversed) pulse may be used to reverse or at least moderate chemical reactions or changes taking place in the interface in response to the first, positive pulse. By generating a reversed pulse, the risk of deterioration of the electrode and/or the tissue at the interface between the electrode and the muscle tissue may be reduced.
In the present example, the electrical signal is a pulsed signal comprising square waves PL1, PL2, PL3, PL4. However, other shapes of the pulses may be employed as well. The pulse signal may be periodic, as shown, or may be intermittent (i.e., multiple series of pulses separated by periods of no pulses). The pulses may have an amplitude A, which may be measured in volts, ampere or the like. Each of the pulses of the signal may have a pulse width D. Likewise, if the signal is periodic, the pulse signal may have a period F that corresponds to a frequency of the signal. Further, the pulses may be either positive or negative in relation to a reference.
The pulse frequency may for example lie within the range of 0.01-150 hertz. More specifically, the pulse frequency may lie within at least one of the ranges of 0.1-1 Hz, 1-10 Hz, 10-50 Hz and 50-150 Hz. It has been observed that relatively low pulse frequencies may be employed to imitate or enhance the slow wave potential associated with pacemaker cells of the smooth muscle tissue. Thus, it may be advantageous to use relatively low pulse frequencies, such as 0.01-0.1 Hz or frequencies below 1 Hz or a few Hz for such applications.
The pulse duration may for example lie within the range of 0.01-100 milliseconds, such as 0.1-20 milliseconds (ms), and preferably such as 1-5 ms. The natural muscle action potential has in some studies been observed to last about 2-4 ms, so it may be advantageous to use a pulse duration imitating that range.
The amplitude may for example lie within the range of 1-15 milliamperes (mA), such as 0.5-5 mA in which range a particularly good muscle contraction response has been observed in some studies.
In a preferred, specific example the electrical stimulation may hence be performed using a pulsed signal having a pulse frequency of 10 Hz, a pulse duration of 3 ms and an amplitude of 3 mA.
The electrode arrangement, which may comprise one or several electrode elements, such as a bare electrode or an electrode at least partly covered by a dielectric material, may be configured to be implanted in the muscle tissue to be stimulated, or to engage the muscle, so as to form an electrode-tissue interface through which the stimulating signal may be transferred. Alternatively, or additionally, the electrode element may be arranged in close vicinity to the muscle tissue such that an electrical coupling between the electrode element and the muscle tissue may be established. This may for example be the case when other tissue, such as connective tissue, is present between the implanted device and the muscle tissue.
The electrode may be electrically connected to the energy storage unit 40, for example by means of a wiring or a lead, such that the electrical signal may be transferred to the electrode-tissue interface. In some examples, the electrode may be integrated with or attached to the implantable pumping device, such that the electrode when implanted in the patient is arranged at the interface between the implantable pumping device and the muscle tissue. The electrode can thereby be used for exercising the muscle tissue that is mechanically affected by the implantable pumping device.
The energy storage unit 40 may for example be of a non-rechargeable type, such as a primary cell, or of a rechargeable type, such as a secondary cell. The energy storage unit 40 may be rechargeable by energy transmitted from outside the body, from an external energy storage unit, or be replaced by surgery. Further, the electrode arrangement 353 may be operably connected to a stimulation controller 353, which may comprise an electrical pulse generator, for generating the electrical pulse. The stimulation controller 350 may be integrated with the energy storage unit 40 or provided as a separate, physically distinct unit which may be configured to be implanted in the body or operate from the outside of the body. In case of the latter, is may be advantageous to allow the external control unit to communicate wirelessly with the stimulation controller for example by means of a communication unit of a more general controller (for example described with reference to
The system may according to some examples comprise a sensor S1 that is configured to sense a physical parameter of the body and/or the implantable pumping device. The sensor S1 may for example be employed to sense or detect a bodily response to the electrical stimulation, such as for example a contraction of the stimulated muscle tissue. In an example, the sensor S1 may be configured to sense action potentials that are being sent to the muscle tissue. The action potentials may for example be generated by pacemaker cells of the muscle tissue, which may be registered by the sensor S1 and transmitted to the stimulation controller 350. The stimulation controller 350 may use the received signal when controlling the energy storage unit 40, such that the generated electrical signal amplifies the sensed action potentials.
The function and features of the controller comprised in the implantable pumping device for controlling the implantable pumping device will now described with reference to
The controller may comprise a collection of communication related sub-units such as a wired transceiver, a wireless transceiver, energy storage unit, an energy receiver, a computing unit, a memory, or a feedback unit. The sub-units of the controller may cooperate with each other or operate independently with different purposes. The sub-units of the controller may inherit the prefix “internal”. This is to distinguish these sub-units from the sub-units of the external devices as similar sub-units may be present for both the implanted controller and the external devices. The sub-units of the external devices may similarly inherit the prefix “external”.
A wireless transceiver may comprise both a wireless transmitter and a wireless receiver. The wireless transceiver may also comprise a first wireless transceiver and a second wireless transceiver. In this case, the wireless transceiver may be part of a first communication system (using the first wireless transceiver) and a second communication system (using the second wireless transceiver).
In some embodiments, two communication systems may be implemented using a single wireless transceiver in e.g. the implant and a single wireless transceiver in e.g. an external device (i.e. one antenna at the implant and one antenna at the external device), but where for example the network protocol used for data transmission from the external device to the implant is different from the network protocol used for data transmission from the implant to the external device, thus achieving two separate communication systems.
Alternatively, the wireless transceiver may be referred to as either a wireless transmitter or a wireless receiver as not all embodiments of secure wireless communication discussed herein require two-way communication capability of the wireless transceiver. The wireless transceiver may transmit or receive wireless communication via wireless connections. The wireless transceiver may connect to both the implant and to external devices, i.e. devices not implanted in the patient.
The wireless connections may be based on radio frequency identification (RFID), near field charge (NFC), Bluetooth, Bluetooth low energy (BLE), or wireless local area network (WLAN). The wireless connections may further be based on mobile telecommunication regimes such as 1G, 2G, 3G, 4G, 5G or 6G. The wireless connections may further be based on modulation techniques such as amplitude modulation (AM), frequency modulation (FM), phase modulation (PM), or quadrature amplitude modulation (QAM). The wireless connection may further feature technologies such as time-division multiple access (TDMA), frequency-division multiple access (FDMA), or code-division multiple access (CDMA). The wireless connection may also be based on infra-red (IR) communication. The wireless connection may feature radio frequencies in the high frequency band (HF), very-high frequency band (VHF), and the ultra-high frequency band (UHF) as well as essentially any other applicable band for electromagnetic wave communication. The wireless connection may also be based on ultrasound communication to name at least one example that does not rely on electromagnetic waves.
A wired transceiver may comprise both a wired transmitter and a wired receiver. The wording wired transceiver aims to distinguish between it and the wireless transceiver. It may generally be considered a conductive transceiver. The wired transceiver may transmit or receive conductive communication via conductive connections. Conductive connections may alternatively be referred to as electrical connections or as wired connections. The wording wired however, does not imply there needs to be a physical wire for conducting the communication. The body tissue of the patient may be considered as the wire. Conductive connection may use the body of the patient as a conductor. Conductive connections may still use ohmic conductors such as metals to at least some extent, and more specifically at the interface between the wired transceiver and the chosen conductor.
Communication, conductive or wireless may be understood as digital or analogue. In analogue communication, the message signal is in analogue form i.e., a continuous time signal. In digital communication, usually digital data i.e., discrete time signals containing information is transmitted.
The controller may comprise a sensation generator. A sensation generator is a device or unit that generates a sensation. The sensation generated may be configured to be experienceable by the patient such that the patient may take actions to authenticate a device, connection or communication. The sensation generator may be configured to generate a single sensation or a plurality of sensation components. The sensation or sensation components may comprise a vibration (e.g. a fixed frequency mechanical vibration), a sound (e.g. a superposition of fixed frequency mechanical vibrations), a photonic signal (e.g. a non-visible light pulse such as an infra-red pulse), a light signal (e.g. a visual light pulse), an electric signal (e.g. an electrical current pulse) or a heat signal (e.g. a thermal pulse). The sensation generator may be implanted, configured to be worn in contact with the skin of the patient or capable of creating sensation without being in physical contact with the patient, such as a beeping alarm.
The sensations generated by the sensation generator may be configured to be experienceable by a sensory function or a sense of the patient from the list of tactile, pressure, pain, heat, cold, taste, smell, sight, and hearing. Sensations may be generated of varying power or force as to adapt to sensory variations in the patient. Power or force may be increased gradually until the patient is able to experience the sensation. Variations in power or force may be controlled via feedback. Sensation strength or force may be configured to stay within safety margins. The sensation generator may be connected to the implant. The sensation generator may be comprised within the implant or be a separate unit.
A motor, e.g. of the active device or unit of the implant, for controlling a physical function in the body of the patient may provide a secondary function as a sensation generator, generating a vibration or sound. Generation of vibrations or sounds of the motor may be achieved by operating the motor at specific frequencies. When functioning as to generate a sensation the motor may operate outside of its normal ranges for frequency controlling a physical function in the body. The power or force of the motor when operating to generate a sensation may also vary from its normal ranges for controlling a physical function in the body.
An external device is a device which is external to the patient in which the implant is implanted in. The external device may be also be enumerated (first, second, third, etc.) to separate different external devices from each other. Two or more external devices may be connected by means of a wired or wireless communication as described above, for example through IP (internet protocol), or a local area network (LAN). The wired or wireless communication may take place using a standard network protocol such as any suitable IP protocol (IPv4, IPv6) or Wireless Local Area Network (IEEE 802.11), Bluetooth, NFC, RFID etc. The wired or wireless communication may take place using a proprietary network protocol. Any external device may also be in communication with the implant using wired or wireless communication according to the above. Communication with implanted devices may be thus accomplished with a wired connection or with wireless radiofrequency (RF) telemetry. Other methods of wireless communication may be used to communicate with implants, including optical and ultrasound. Alternatively, the concept of intrabody communication may be used for wireless communication, which uses the conductive properties of the body to transmit signals, i.e. conductive (capacitive or galvanic) communication with the implant. Means for conductive communication between an external device and an implant may also be called “electrical connection” between an external device and an implant. The conductive communication may be achieved by placing a conductive member of the external device in contact with the skin of the patient. By doing this, the external device and/or the implant may assure that it is in direct electrical connection with the other device. The concept relies on using the inherent conductive or electrical properties of a human body. Signals may preferably be configured to affect the body or body functions minimally. For conductive communication this may mean using low currents. A current may flow from an external device to an implant or vice versa. Also, for conductive communication, each device may have a transceiver portion for transmitting or receiving the current. These may comprise amplifiers for amplifying at least the received current. The current may contain or carry a signal which may carry e.g. an authentication input, implant operation instructions, or information pertaining to the operation of the implant.
Alternatively, conductive communication may be referred to as electrical or ohmic or resistive communication.
The conductive member may be an integrated part of the external device (e.g. in the surface of a smartwatch that is intended to be in contact with the wrist of the person wearing it), or it may be a separate device which can be connected to the external device using a conductive interrace such as the charging port or the headphone port of a smartphone.
A conductive member may be considered any device or structure set up for data communication with the implant via electric conductive body tissue. The data communication to the implant may be achieved by e.g. current pulses transmitted from the conductive member through the body of the patient to be received by a receiver at the implant. Any suitable coding scheme known in the art may be employed. The conductive member may comprise an energy storage unit such as a battery or receive energy from e.g. a connected external device.
The term conductive interface is representing any suitable interface configured for data exchange between the conductive member and the external device. The conductive member may in an alternative configuration receive and transmit data to the external device through a radio interface, NFC, and the like.
An external device may act as a relay for communication between an implant and a remote device, such as e.g. second, third, or other external devices. Generally, the methods of relaying communication via an external device may be preferable for a large number of reasons. The transmission capabilities of the implant may be reduced, reducing its technical complexity, physical dimensions, and medical effects on the patient in which the implant is implanted. Communication may also be more efficient as direct communication, i.e. without a relaying device, with an implant from a remote device may require higher energy transmissions to account for different mediums and different rates of attenuation for different communication means. Remote communication with lower transmission energy may also increase the security of the communication as the spatial area or volume where the communication may be at all noticeable may be made smaller. Utilizing such a relay system further enables the use of different communication means for communication with the implant and communication with remote devices that are more optimized for their respective mediums.
An external device may be any device having processing power or a processor to perform the methods and functions needed to provide safe operation of the implant and provide the patient or other stakeholders (caregiver, spouse, employer etc.) with information and feedback from the implant. Feedback parameters could include battery status, energy level at the controller, the fluid level of the hydraulic restriction device, number of operations that the restriction device has performed, properties, version number etc. relating to functionality of the implantable pumping device. The external device may for example be a handset such as a smartphone, smartwatch, tablet etc. handled by the patient or other stakeholders. The external device may be a server or personal computer handled by the patient or other stakeholders. The external device may be cloud based or a virtual machine. In the drawings, the external device handled by the patient is often shown as a smart watch, or a device adapted to be worn by the patient at the wrist of the patient. This is merely by way of example and any other type of external device, depending on the context, is equally applicable.
Several external devices may exist such as a second external device, a third external device, or another external device. The above listed external devices may e.g. be available to and controllable by a patient, in which an implant is implanted, a caregiver of the patient, a healthcare professional of the patient, a trusted relative of the patient, an employer or professional superior of the patient, a supplier or producer of the implant or its related features. By controlling the external devices may provide options for e.g. controlling or safeguarding a function of the implant, monitoring the function of the implant, monitoring parameters of the patient, updating or amending software of the implant etc.
An external device under control by a supplier or producer of the implant may be connected to a database comprising data pertaining to control program updates and/or instructions. Such database may be regularly updated to provide new or improved functionality of the implant, or to mitigate for previously undetected flaws of the implant. When an update of a control program of an implant is scheduled, the updated control program may be transmitted from the database in a push mode and optionally routed via one or more further external devices before received by the implanted controller. In another embodiment, the update is received from the database by request from e.g. an external device under control by the patient having the implant implanted in his/her body, a pull mode.
The external device may require authentication to be operated in communication with other external devices or the implant. Passwords, multi-factor authentication, biometric identification (fingerprint, iris scanner, facial recognition, etc.) or any other way of authentication may be employed.
The external device may have a user interface (UI) for receiving input and displaying information/feedback from/to a user. The UI may be a graphical UI (GUI), a voice command interface, speaker, vibrators, lamps, etc.
The communication between external devices, or between an external device and the implant may be encrypted. Any suitable type of encryption may be employed such as symmetric or asymmetric encryption. The encryption may be a single key encryption or a multi-key encryption. In multi-key encryption, several keys are required to decrypt encrypted data. The several keys may be called first key, second key, third key, etc. or first part of a key, second part of the key, third part of the key, etc. The several keys are then combined in any suitable way (depending on the encryption method and use case) to derive a combined key which may be used for decryption. In some cases, deriving a combined key is intended to mean that each key is used one by one to decrypt data, and that the decrypted data is achieved when using the final key.
In other cases, the combination of the several key result in one “master key” which will decrypt the data. In other words, it is a form of secret sharing, where a secret is divided into parts, giving each participant (external device(s), internal device) its own unique part. To reconstruct the original message (decrypt), a minimum number of parts (keys) is required. In a threshold scheme this number is less than the total number of parts (e.g. the key at the implant and the key from one of the two external device are needed to decrypt the data). In other embodiments, all keys are needed to reconstruct the original secret, to achieve the combined key which may decrypt the data.
In should be noted that it is not necessary that the generator of a key for decryption is the unit that in the end sends the key to another unit to be used at that unit. In some cases, the generator of a key is merely a facilitator of encryption/decryption, and the working in behalf of another device/user.
A verification unit may comprise any suitable means for verifying or authenticating the use (i.e. user authentication) of a unit comprising or connected to the verification unit, e.g. the external device. For example, a verification unit may comprise or be connected to an interface (UI, GUI) for receiving authentication input from a user. The verification unit may comprise a communication interface for receiving authentication data from a device (separate from the external device) connected to the device comprising the verification unit. Authentication input/data may comprise a code, a key, biometric data based on any suitable techniques such as fingerprint, a palm vein structure, image recognition, face recognition, iris recognition, a retinal scan, a hand geometry, and genome comparison, etc. The verification/authentication may be provided using third party applications, installed at or in connection with the verification unit.
The verification unit may be used as one part of a two-part authentication procedure. The other part may e.g. comprise conductive communication authentication, sensation authentication, or parameter authentication.
The verification unit may comprise a card reader for reading a smart card. A smart card is a secure microcontroller that is typically used for generating, storing and operating on cryptographic keys. Smart card authentication provides users with smart card devices for the purpose of authentication. Users connect their smart card to the verification unit. Software on the verification unit interacts with the keys material and other secrets stored on the smart card to authenticate the user. In order for the smart card to operate, a user may need to unlock it with a user-PIN. Smart cards are considered a very strong form of authentication because cryptographic keys and other secrets stored on the card are very well protected both physically and logically, and are therefore hard to steal.
The verification unit may comprise a personal e-ID that is comparable to, for example, passport and driving license. The e-ID system comprises is a security software installed at the verification unit, and a e-ID which is downloaded from a web site of a trusted provided or provided via a smart card from the trusted provider.
The verification unit may comprise software for SMS-based two-factor authentication. Any other two-factor authentication systems may be used. Two-factor authentication requires two things to get authorized: something you know (your password, code, etc.) and something you have (an additional security code from your mobile device (e.g. a SMS, or a e-ID) or a physical token such as a smart card).
Other types of verification/user authentication may be employed. For example, a verification unit which communicate with an external device using visible light instead of wired communication or wireless communication using radio. A light source of the verification unit may transmit (e.g. by flashing in different patterns) secret keys or similar to the external device which uses the received data to verify the user, decrypt data or by any other means perform authentication. Light is easier to block and hide from an eavesdropping adversary than radio waves, which thus provides an advantage in this context. In similar embodiments, electromagnetic radiation is used instead of visible light for transmitting verification data to the external device.
Parameters relating to functionality of the implant may comprise for example a status indicator of the implant such as battery level, version of control program, properties of the implant, status of a motor of the implant, etc.
Data comprising operating instructions sent to the implant may comprise a new or updated control program, parameters relating to specific configurations of the implant, etc. Such data may for example comprise instructions how to operate the body engaging portion of the implantable pumping device, instructions to collect patient data, instructions to transmit feedback, etc.
The expressions “confirming the electrical connection between an implant and an external device” or “authenticating a connection between an implant and an external device”, or similar expressions, are intended to encompass methods and processes for ensuring or be reasonably sure that the connection has not been compromised. Due to weaknesses in the wireless communication protocols, it is a simple task for a device to “listen” to the data and grab sensitive information, e.g. personal data regarding the patient sent from the implant, or even to try to compromise (hack) the implant by sending malicious commands or data to the implant. Encryption may not always be enough as a security measure (encryption schemes may be predictable), and other means of confirming or authenticating the external device being connected to the implant may be needed.
The expression “network protocol” is intended to encompass communication protocols used in computer networks. a communication protocol is a system of rules that allow two or more entities of a communications system to transmit information via any kind of variation of a physical quantity. The protocol defines the rules, syntax, semantics and synchronization of communication and possible error recovery methods. Protocols may be implemented by hardware, software, or a combination of both. Communication protocols have to be agreed upon by the parties involved. In this field, the term “standard” and “proprietary” is well defined. A communication protocol may be developed into a protocol standard by getting the approval of a standards organization. To get the approval the paper draft needs to enter and successfully complete the standardization process. When this is done, the network protocol can be referred to a “standard network protocol” or a “standard communication protocol”. Standard protocols are agreed and accepted by whole industry. Standard protocols are not vendor specific. Standard protocols are often, as mentioned above, developed by collaborative effort of experts from different organizations.
Proprietary network protocols, on the other hand, are usually developed by a single company for the devices (or Operating System) which they manufacture. A proprietary network protocol is a communications protocol owned by a single organization or individual. Specifications for proprietary protocols may or may not be published, and implementations are not freely distributed. Consequently, any device may not communicate with another device using a proprietary network protocol, without having the license to use the proprietary network protocol, and knowledge of the specifications for proprietary protocol. Ownership by a single organization thus gives the owner the ability to place restrictions on the use of the protocol and to change the protocol unilaterally.
A control program is intended to define any software used for controlling the implant. Such software may comprise an operating system of the implant, of parts of an operating system or an application running on the implant such as software controlling a specific functionality of the implant (e.g. the active unit of the implant, feedback functionality of the implant, a transceiver of the implant, encoding/decoding functionality of the implant, etc.). The control program may thus control the medical function of the implant, for example the pressure applied by the constriction device or the power of the electrical stimulation device. Alternatively or additionally, the control program may control internal hardware functionality of the implant such as energy usage, transceiver functionality, etc.
The systems and methods disclosed hereinabove may be implemented as software, firmware, hardware or a combination thereof. In a hardware implementation, the division of tasks between functional units referred to in the above description does not necessarily correspond to the division into physical units; to the contrary, one physical component may have multiple functionalities, and one task may be carried out by several physical components in cooperation. Certain components or all components may be implemented as software executed by a digital signal processor or microprocessor or be implemented as hardware or as an application-specific integrated circuit. Such software may be distributed on computer readable media, which may comprise computer storage media (or non-transitory media) and communication media (or transitory media). As is well known to a person skilled in the art, the term computer storage media includes both volatile and non-volatile, removable and non-removable media implemented in any method or technology for storage of information such as computer readable instructions, data structures, program modules or other data. Computer storage media includes, but is not limited to, RAM, ROM, EEPROM, flash memory or other memory technology, CD-ROM, digital versatile disks (DVD) or other optical disk storage, magnetic cassettes, magnetic tape, magnetic disk storage or other magnetic storage devices, or any other medium which can be used to store the desired information, and which can be accessed by a computer. Further, it is well known to the skilled person that communication media typically embodies computer readable instructions, data structures, program modules or other data in a modulated data signal such as a carrier wave or other transport mechanism and includes any information delivery media.
A controller for controlling the implantable pumping device according to any of the embodiments herein and for communicating with devices external to the body of the patient and/or implantable sensors will now be described with reference to
Referring now to
The second control program 312 is the program controlling the implantable pumping device in normal circumstances, providing the implantable pumping device with full functionality and features.
The memory 307 can further comprise a second, updatable, control program 312. The term updatable is to be interpreted as the program being configured to receive incremental or iterative updates to its code, or be replaced by a new version of the code. Updates may provide new and/or improved functionality to the implant as well as fixing previous deficiencies in the code. The computing unit 306 can receive updates to the second control program 312 via the controller 300. The updates can be received wirelessly WL1 or via the electrical connection C1. As shown in
The controller 300 may comprise a reset function 316 connected to or part of the internal computing unit 306 or transmitted to said internal computing unit 306. The reset function 316 is configured to make the internal computing unit 306 switch from running the second control program 312 to the first control program 310. The reset function 316 could be configured to make the internal computing unit 306 delete the second control program 312 from the memory 307. The reset function 316 can be operated by palpating or pushing/put pressure on the skin of the patient. This could be performed by having a button on the implant. Alternatively, the reset function 316 can be invoked via a timer or a reset module. Temperature sensors and/or pressure sensors can be utilized for sensing the palpating. The reset function 316 could also be operated by penetrating the skin of the patient. It is further plausible that the reset function 316 can be operated by magnetic means. This could be performed by utilizing a magnetic sensor and applying a magnetic force from outside the body. The reset function 316 could be configured such that it only responds to magnetic forces applied for a duration of time exceeding a limit, such as 2 seconds. The time limit could equally plausible be 5 or 10 seconds, or longer. In these cases, the implant could comprise a timer. The reset function 316 may thus include or be connected to a sensor for sensing such magnetic force.
In addition to or as an alternative to the reset function described above, the implant may comprise an internal computing unit 306 (comprising an internal processor) comprising the second control program 312 for controlling a function of the implantable pumping device, and a reset function 318. The reset function 318 may be configured to restart or reset said second control program 312 in response to: i. a timer of the reset function 318 has not been reset, or ii. a malfunction in the first control program 310.
The reset function 318 may comprise a first reset function, such as, for example, comprise a computer operating properly, COP, function connected to the internal computing unit 306. The first reset function may be configured to restart or reset the first or the second control program 312 using a second reset function. The first reset function comprises a timer, and the first or the second control program is configured to periodically reset the timer.
The reset function 318 may further comprise a third reset function connected to the internal computing unit and to the second reset function. The third reset function may in an example be configured to trigger a corrective function for correcting the first 310 or second control program 312, and the second reset function is configured to restart the first 310 or second control program 312 some time after the corrective function has been triggered. The corrective function may be a soft reset or a hard reset.
The second or third reset function may, for example, configured to invoke a hardware reset by triggering a hardware reset by activating an internal or external pulse generator which is configured to create a reset pulse. Alternatively, the second or third reset function may be implemented by software.
The controller 300 may further comprise an internal wireless transceiver 308. The transceiver 308 communicates wirelessly with the external device 320 through the wireless connection W1. The transceiver may further communicate with an external device 320, 300 via wireless connection WL2 or WL4. The transceiver may both transmit and receive data via either of the connections C1, WL1, WL2 and WL4. Optionally, the external devices 320 and 300, when present, may communicate with each other, for example via a wireless connection WL3.
The controller 300 can further be electrically connected C1 to the external device 320 and communicate by using the patient's body as a conductor. The controller 300 may thus comprise a wired transceiver 303 or an internal transceiver 303 for the electrical connection C1.
The confirmation/authentication of the electrical connection can be performed as described herein in the section for confirmation and/or authentication. In these cases, the implantable pumping device and/or external device(s) 320 comprises the necessary features and functionality (described in the respective sections of this document) for performing such confirmation/authentication. By authenticating according to these aspects, security of the authentication may be increased as it may require a malicious third party to know or gain access to either the transient physiological parameter of the patient or detect randomized sensations generated at or within the patient.
In
The controller 300 of the implantable pumping device 10 according to
As seen in
The controller 300 of the implantable pumping device 10 according to
The switch 309 could either be configured to cut the power to the operation device or to generate a control signal to the processor 306 of the implantable controller 300, such that the controller 300 can take appropriate action, such as reducing power or turning off the operation device.
The external device 320 is represented in
The second, third or fourth communication methods WL2, WL3, WL4 may be a wireless form of communication. The second, third or fourth communication method WL2, WL3, WL4 may preferably be a form of electromagnetic or radio-based communication. The second, third and fourth communication method WL2, WL3, WL4 may be based on telecommunication methods. The second, third or fourth communication method WL2, WL3, WL4 may comprise or be related to the items of the following list: Wireless Local Area Network (WLAN), Bluetooth, Bluetooth 5, BLE, GSM or 2G (2nd generation cellular technology), 3G, 4G, 5G or 6G.
The external device 320 may be adapted to be in electrical connection C1 with the implantable pumping device 10, using the body as a conductor. The electrical connection C1 is in this case used for conductive communication between the external device 320 and the implantable pumping device 10.
In one embodiment, the communication between controller 300 and the external device 320 over either of the communication methods WL2, WL3, WL4, C1 may be encrypted and/or decrypted with public and/or private keys, now described with reference to
The controller 320 and the external device 320 may exchange public keys and the communication may thus be performed using public key encryption. The person skilled in the art may utilize any known method for exchanging the keys.
The controller may encrypt data to be sent to the external device 320 using a public key corresponding to the external device 320. The encrypted data may be transmitted over a wired, wireless or electrical communication channel C1, WL1, WL2, WL3 to the external device. The external device 320 may receive the encrypted data and decode it using the private key comprised in the external device 320, the private key corresponding to the public key with which the data has been encrypted. The external device 320 may transmit encrypted data to the controller 300. The external device 320 may encrypt the data to be sent using a public key corresponding to the private key of the controller 300. The external device 320 may transmit the encrypted data over a wired, wireless or electrical connection C1, WL1, WL2, WL3, WL4, directly or indirectly, to the controller of the implant. The controller may receive the data and decode it using the private key comprised in the controller 300.
In an alternative to the public key encryption, described with reference to
A method for communication between an external device 320 and the controller 300 of the implantable pumping device 10 using a combined key is now described with reference to
In case the controller 300 is receiving the second key from the external device 320, this means that the second key is routed through the external device from the second external device 330 or from another external device (generator). The routing may be performed as described herein under the tenth aspect. In these cases, the implant and/or external device(s) comprises the necessary features and functionality (described in the respective sections of this document) for performing such routing. Using the external device 320 as a relay, with or without verification from the patient, may provide an extra layer of security as the external device 320 may not need to store or otherwise handle decrypted information. As such, the external device 320 may be lost without losing decrypted information. The controller 300 comprises a computing unit 306 configured for deriving a combined key by combining the first key and the second key with a third key held by the controller 300, for example in memory 307 of the controller 300. The third key could for example be a license number of the implant or a chip number of the implantable pumping device. The combined key may be used for decrypting, by the computing unit 306, encrypted data transmitted by a wireless transmission WL1 from the external device 320 to the controller 300. Optionally, the decrypted data may be used for altering, by the computing unit 306 an operation of the implantable pumping device. The altering an operation of the implantable pumping device may comprise controlling or switching an active unit 302 of the implant. In some embodiments, the method further comprises at least one of the steps of, based on the decrypted data, updating a control program running in the controller 300, and operating the implantable pumping device 10 using operation instructions in the decrypted data.
Methods for encrypted communication between an external device 320 and the controller 300 are provided. These methods comprise:
As described above, further keys may be necessary to decrypt the data. Consequently, the wireless transceiver 328 is configured for:
These embodiments further increase the security in the communication. The computing unit 326 may be configured to confirm the communication between the implant and the external device, wherein the confirmation comprises:
The keys described in this section may in some embodiments be generated based on data sensed by sensors described herein under the twelfth or thirteenth aspect, e.g. using the sensed data as seed for the generated keys. A seed is an initial value that is fed into a pseudo random number generator to start the process of random number generation. The seed may thus be made hard to predict without access or knowledge of the physiological parameters of the patient which it is based on, providing an extra level of security to the generated keys.
Further, increased security for communication between an external device(s) and the implantable pumping device is provided.
A method of communication between an external device 320 and an implantable pumping device 10 is now described with reference to
In a first step of the method, the electrical connection C1 between the controller 300 and the external device 320 is confirmed and thus authenticated. The confirmation and authentication of the electrical connection may be performed as described herein. In these cases, the implant and/or external device(s) comprises the necessary features and functionality (described in the respective sections of this document) for performing such authentication. By authenticating according to these aspects, security of the authentication may be increased as it may require a malicious third party to know or gain access to either the transient physiological parameter of the patient or detect randomized sensations generated at or within the patient.
The implant may comprise a first transceiver 303 configured to be in electrical connection C1 with the external device, using the body as a conductor. The implant may comprise a first external transmitter 203 configured to be in electrical connection C1 with the implant, using the body as a conductor, and the wireless transmitter 208 configured to transmit wireless communication W1 to the controller 300. The first transmitter 323 of the external device 320 may be wired or wireless. The first transmitter 323 and the wireless transmitter 208 may be the same or separate transmitters. The first transceiver 303 of the controller 300 may be wired or wireless. The first transceiver 303 and the wireless transceiver 102 may be the same or separate transceivers.
The controller 300 may comprise a computing unit 306 configured to confirm the electrical connection between the external device 320 and the internal transceiver 303 and accept wireless communication WL1 (of the data) from the external device 320 on the basis of the confirmation.
Data is transmitted from the external device 320 to the controller 300 wirelessly, e.g. using the respective wireless transceiver 308, 208 of the controller 300 and the external device 320. Data may alternatively be transmitted through the electrical connection C1. As a result of the confirmation, the received data may be used for instructing the implantable pumping device 10. For example, a control program 310 running in the controller 300 may be updated, the controller 300 may be operated using operation instructions in the received data. This may be handled by the computing unit 306.
The method may comprise transmitting data from the external device 320 to the controller 300 wirelessly comprises transmitting encrypted data wirelessly. To decrypt the encrypted data (for example using the computing unit 306), several methods may be used.
In one embodiment, a key is transmitted using the confirmed conductive communication channel C1 (i.e. the electrical connection) from the external device 320 to the controller 300. The key is received at the controller (by the first internal transceiver 303). The key is then used for decrypting the encrypted data.
In some embodiments the key is enough to decrypt the encrypted data. In other embodiments, further keys are necessary to decrypt the data. In one embodiment, a key is transmitted using the confirmed conductive communication channel C1 (i.e. the electrical connection) from the external device 320 to the controller 300. The key is received at the controller 300 (by the first internal transceiver 303). A second key is transmitted (by the wireless transceiver 208) from the external device 320 using the wireless communication WL1 and received at the controller 300 by the wireless transceiver 308. The computing unit 306 is then deriving a combined key from the key and second key and uses this for decrypting the encrypted data.
In yet other embodiments, a key is transmitted using the confirmed conductive communication channel C1 (i.e. the electrical connection) from the external device 320 to the controller 300. The key is received at the controller (by the first internal transceiver 303). A third key is transmitted from a second external device 330, separate from the external device 320, to the implant wirelessly WL2. The third key may be received by a second wireless receiver (part of the wireless transceiver 308) of the controller 300 configured for receiving wireless communication WL2 from second external device 330.
The first and third key may be used to derive a combined key by the computing unit 306, which then decrypts the encrypted data. The decrypted data is then used for instructing the implantable pumping device 10 as described above.
The second external device 330 may be controlled by for example a caregiver, to further increase security and validity of data sent and decrypted by the controller 300.
It should be noted that in some embodiments, the external device is further configured to receive WL2 secondary wireless communication from the second external device 330, and transmit data received from the secondary wireless communication WL2 to the implantable pumping device. This routing of data may be achieved using the wireless transceivers 308, 208 (i.e. the wireless connection WL1, or by using a further wireless connection WL4 between the controller 300 and the external device 320. In these cases, the implant and/or external device(s) comprises the necessary features and functionality for performing such routing. Consequently, in some embodiments, the third key is generated by the second external device 330 and transmitted WL2 to the external device 320 which routes the third key to the controller 300 to be used for decryption of the encrypted data. In other words, the step of transmitting a third key from a second external device, separate from the external device, to the implant wirelessly, comprises routing the third key through the external device 320. Using the external device 320 as a relay, with or without verification from the patient, may provide an extra layer of security as the external device 320 may not need to store or otherwise handle decrypted information. As such, the external device 320 may be lost without losing decrypted information.
In yet other embodiments, a key is transmitted using the confirmed conductive communication channel C1 (i.e. the electrical connection) from the external device 320 to the controller 300. The key is received at the implant (by the first internal transceiver 303). A second key is transmitted from the external device 320 to the controller 300 wirelessly WL1, received at the at the controller 300. A third key is transmitted from the second external device, separate from the external device 320, to the controller 300 wirelessly WL4. Encrypted data transmitted from the external device 320 to the controller 300 is then decrypted using a derived combined key from the key, the second key and the third key. The external device may be a wearable external device.
The external device 320 may be a handset. The second external device 330 may be a handset. The second external device 330 may be a server. The second external device 330 may be cloud based.
In some embodiments, the electrical connection C1 between the external device 320 and the controller 300 is achieved by placing a conductive member 201, configured to be in connection with the external device 200, in electrical connection with a skin of the patient for conductive communication C1 with the implant. In these cases, the implant and/or external device(s) comprises the necessary features and functionality (described in the respective sections of this document) for performing such conductive communication. The communication may thus be provided with an extra layer of security in addition to the encryption by being electrically confined to the conducting path e.g. external device 320, conductive member 201, conductive connection C1, controller 300, meaning the communication will be excessively difficult to be intercepted by a third party not in physical contact with, or at least proximal to, the patient.
The keys described in this section may in some embodiments be generated based on data sensed by sensors described herein, e.g. using the sensed data as seed for the generated keys. A seed is an initial value that is fed into a pseudo random number generator to start the process of random number generation. The seed may thus be made hard to predict without access or knowledge of the physiological parameters of the patient which it is based on, providing an extra level of security to the generated keys.
Increased security for communication between an external device(s) and an implant is provided, now described with reference to
In these embodiments, a method for communication between an external device 320 and the implantable controller 300 is provided. The wireless transceiver 308 (included in the controller 300) may in some embodiments comprise sub-transceivers for receiving data from the external device 320 and other external devices 330, e.g. using different frequency bands, modulation schemes etc.
A first step of the method comprises receiving, at the implant, by a wireless transmission WL1 or otherwise, a first key from an external device 320. The method further comprises receiving, at the implant, by a wireless transmission WL1, WL2, WL3, a second key. The second key may be generated by a second external device 330, separate from the external device 320 or by another external device being a generator of the second key on behalf of the second external device 330. The second key may be received at the implant from anyone of, the external device 320, the second external device 330, and a generator of the second key. The second external device 330 may be controlled by a caretaker, or any other stakeholder. Said another external device may be controlled by a manufacturer of the implant, or medical staff, caretaker, etc.
In case the implant is receiving the second key from the external device 320, this means that the second key is routed through the external device from the second external device 330 or from the another external device (generator). In these cases, the implant and/or external device(s) comprises the necessary features and functionality (described in the respective sections of this document) for performing such routing. Using the external device 320 as a relay, with or without verification from the patient, may provide an extra layer of security as the external device 320 may not need to store or otherwise handle decrypted information. As such, the external device 320 may be lost without losing decrypted information.
The controller 300 comprises a computing unit 306 configured for deriving a combined key by combining the first key and the second key with a third key held by the controller 300, for example in memory 307 of the controller. The combined key may be used for decrypting, by the computing unit 306, encrypted data transmitted by a wireless transmission WL1 from the external device 320 to the controller 300. Optionally, the decrypted data may be used for altering, by the computing unit 306 an operation of the implantable pumping device 10. The altering an operation of the implantable pumping device may comprise controlling or switching an active unit 302 of the implant. In some embodiments, the method further comprises at least one of the steps of, based on the decrypted data, updating a control program running in the implant, and operating the implantable pumping device 10 using operation instructions in the decrypted data.
In some embodiments, further keys are necessary to derive a combined key for decrypting the encrypted data received at the controller 300. In these embodiments, the first and second key are received as described above. Further, the method comprises receiving, at the implant, a fourth key from a third external device, the third external device being separate from the external device, deriving a combined key by combining the first, second and fourth key with the third key held by the controller 300, and decrypting the encrypted data, in the controller 300, using the combined key. Optionally, the decrypted data may be used for altering, by the computing unit 306, an operation of the implant as described above. In some embodiments, the fourth key is routed through the external device from the third external device.
In some embodiments, further security measures are needed before using the decrypted data for altering, by the computing unit 306, an operation of the implantable pumping device. For example, an electrical connection C1 between the implantable pumping device and the external device 320, using the body as a conductor, may be used for further verification of validity of the decrypted data. The electrical connection C1 may be achieved by placing a conductive member 201, configured to be in connection with the external device, in electrical connection with a skin of the patient for conductive communication C1 with the implant. The communication may thus be provided with an extra layer of security in addition to the encryption by being electrically confined to the conducting path e.g. external device 320, conductive member 201, conductive connection C1, controller 300, meaning the communication will be excessively difficult to be intercepted by a third party not in physical contact with, or at least proximal to, the patient.
Accordingly, in some embodiments, the method comprising confirming the electrical connection between the controller 300 and the external device 320, and as a result of the confirmation, altering an operation of the implantable pumping device based on the decrypted data. The confirmation and authentication of the electrical connection may be performed as described herein under the general features section. In these cases, the implantable pumping device and/or external device(s) 320 comprises the necessary features and functionality (described in the respective sections of this document) for performing such authentication. By authenticating according to these aspects, security of the authentication may be increased as it may require a malicious third party to know or gain access to either the transient physiological parameter of the patient or detect randomized sensations generated at or within the patient.
In some embodiments, the confirmation of the electrical connection comprises: measuring a parameter of the patient, by e.g. a sensor of the implantable pumping device 10, measuring the parameter of the patient, by the external device 320, comparing the parameter measured by the implantable pumping device to the parameter measured by the external device 320, and authenticating the connection based on the comparison. As mentioned above, as a result of the confirmation, an operation of the implantable pumping device may be altered based on the decrypted data.
Further methods for encrypted communication between an external device 320 and an implantable pumping device 10 are provided. These methods comprise:
As described above, further keys may be necessary to decrypt the data. Consequently, the wireless transceiver 328 is configured for:
In some embodiments, the communication between the controller 300 and the external device 320 needs to be confirmed (authenticated) before decrypting the data. In these cases, the implant and/or external device(s) comprises the necessary features and functionality (described in the respective sections of this document) for performing such authentication.
These embodiments further increase the security in the communication. In these embodiments the computing unit 326 is configured to confirm the communication between the implant and the external device, wherein the confirmation comprises:
One or more of the first, second and third key may comprise a biometric key.
The keys described in this section may in some embodiments be generated based on data sensed by sensors, e.g. using the sensed data as seed for the generated keys. A seed is an initial value that is fed into a pseudo random number generator to start the process of random number generation. The seed may thus be made hard to predict without access or knowledge of the physiological parameters of the patient which it is based on, providing an extra level of security to the generated keys.
Further, increased security for communication between an external device(s) 320, 330 and an implant is provided, described with reference to
Electrical or conductive communication, such as this or as described under the other embodiments, may be very hard to detect remotely, or at least relatively so, in relation to wireless communications such as radio transmissions. Direct electrical communication may further safeguard the connection between the implantable pumping device 10 and the external device 320 from electromagnetic jamming i.e. high-power transmissions other a broad range of radio frequencies aimed at drowning other communications within the frequency range. Electrical or conductive communication will be excessively difficult to be intercepted by a third party not in physical contact with, or at least proximal to, the patient, providing an extra level of security to the communication.
In some embodiments, the conductive member comprises a conductive interface for connecting the conductive member to the external device.
In some embodiments, the conductive member 201 is a device which is plugged into the external device 200, and easily visible and identifiable for simplified usage by the patient. In other embodiments, the conductive member 321 is to a higher degree integrated with the external device 320, for example in the form of a case of the external device 320 comprising a capacitive area configured to be in electrical connection with a skin of the patient. In one example, the case is a mobile phone case (smartphone case) for a mobile phone, but the case may in other embodiments be a case for a personal computer, or a body worn camera or any other suitable type of external device as described herein. The case may for example be connected to the phone using a wire from the case and connected to the headphone port or charging port of the mobile phone.
The conductive communication C1 may be used both for communication between the controller 300 and the external device 320 in any or both directions. Consequently, according to some embodiments, the external device 320 is configured to transmit a conductive communication (conductive data) to the controller 300 via the conductive member 321.
According to some embodiments, the controller 300 is configured to transmit a conductive communication to the external device 320. These embodiments start by placing the conductive member 321, configured to be in connection with the external device 320, in electrical connection with a skin of the patient for conductive communication C1 with the controller 300. The conductive communication between the external device 320 and the controller 300 may follow an electrically/conductively confined path comprising e.g. the external device 320, conductive member 321, conductive connection C1, controller 300.
For the embodiments when the external device 320 transmits data to the controller, the communication may comprise transmitting a conductive communication to the controller 300 by the external device 320.
The transmitted data may comprise instructions for operating the implantable pumping device 10. Consequently, some embodiments comprise operating the implantable pumping device 10 using operation instructions, by an internal computing unit 306 of the controller 300, wherein the conductive communication C1 comprises instructions for operating the implantable pumping device 10. The operation instruction may for example involve adjusting or setting up (e.g. properties or functionality of) the active unit 302 of the implantable pumping device 10.
The transmitted data may comprise instructions for updating a control program 310 stored in memory 307 of the controller 300. Consequently, some embodiments comprise updating the control program 310 running in the controller 300, by the internal computing unit 306 of the implant, wherein the conductive communication comprises instructions for updating the control program 310.
For the embodiments when the controller 300 transmits data to the external device 320, the communication may comprise transmitting conductive communication C1 to the external device 320 by the controller 300. The conductive communication may comprise feedback parameters. Feedback parameters could include battery status, energy level at the controller, the fluid level of the hydraulic restriction device, number of operations that the restriction device has performed, properties, version number etc. relating to functionality of the implantable pumping device 10. In other embodiments, the conductive communication C1 comprises data pertaining to least one physiological parameter of the patient, such as blood pressure etc. The physiological parameter(s) may be stored in memory 307 of the controller 300 or sensed in prior (in real time or with delay) to transmitting the conductive communication C1. Consequently, in some embodiments, the implantable pumping device 10 comprises a sensor 150 for sensing at least one physiological parameter of the patient, wherein the conductive communication comprises said at least one physiological parameter of the patient.
To further increase security of the communication between the controller 300 and the external device 320, different types of authentication, verification and/or encryption may be employed. In some embodiments, the external device 320 comprises a verification unit 340. The verification unit 340 may be any type of unit suitable for verification of a user, i.e. configured to receive authentication input from a user, for authenticating the conductive communication between the implant and the external device. In some embodiments, the verification unit and the external device comprises means for collecting authentication input from the user (which may or may not be the patient). Such means may comprise a fingerprint reader, a retina scanner, a camera, a GUI for inputting a code, a microphone, device configured to draw blood, etc. The authentication input may thus comprise a code or any be based on a biometric technique selected from the list of: a fingerprint, a palm vein structure, image recognition, face recognition, iris recognition, a retinal scan, a hand geometry, and genome comparison. The means for collecting the authentication input may alternatively be part of the conductive member which comprise any of the above examples of functionality, such as a fingerprint reader or other type of biometric reader.
In some embodiments, the security may thus be increased by receiving an authentication input from a user by the verification unit 340 of the external device 320, and authenticating the conductive communication between the controller 300 and the external device using the authentication input. Upon a positive authentication, the conductive communication channel C1 may be employed for comprising transmitting a conductive communication to the controller 300 by external device 320 and/or transmitting a conductive communication to the external device 320 by the controller 300. In other embodiments, a positive authentication is needed prior to operating the implantable pumping device 10 based on received conductive communication, and/or updating a control program running in the controller 300 as described above.
The sensation generator 381 may be configured to generate a sensation. The sensation generator 381 may be contained within the implantable pumping device 10 or be a separate unit. The sensation generator 381 may be implanted. The sensation generator 381 may also be located so that it is not implanted as such but still is in connection with a patient so that only the patient may experience sensations generated. The controller 300 is configured for storing authentication data, related to the sensation generated by the sensation generator 381.
The controller 300 is further configured for receiving input authentication data from the external device 320. Authentication data related to the sensation generated may by stored by a memory 307 of the controller 300. The authentication data may include information about the generated sensation such that it may be analyzed, e.g. compared, to input authentication data to authenticate the connection, communication or device. Input authentication data relates to information generated by a patient input to the external device 320. The input authentication data may be the actual patient input or an encoded version of the patient input, encoded by the external device 320. Authentication data and input authentication data may comprise a number of sensations or sensation components.
The authentication data may comprise a timestamp. The input authentication data may comprise a timestamp of the input from the patient. The timestamps may be a time of the event such as the generation of a sensation by the sensation generator 381 or the creation of input authentication data by the patient. The timestamps may be encoded. The timestamps may feature arbitrary time units, i.e. not the actual time. Timestamps may be provided by an internal clock 360 of the controller 300 and an external clock 362 of the external device 320. The clocks 360, 362 may be synchronized with each other. The clocks 360, 362 may be synchronized by using a conductive connection C1 or a wireless connection WL1 for communicating synchronization data from the external device 320, and its respective clock 362, to the controller 300, and its respective clock 360, and vice versa. Synchronization of the clocks 360, 362 may be performed continuously and may not be reliant on secure communication.
Authentication of the connection may comprise calculating a time difference between the timestamp of the sensation and the timestamp of the input from the patient, and upon determining that the time difference is less than a threshold, authenticating the connection. An example of a threshold may be is. The analysis may also comprise a low threshold as to filter away input from the patient that is faster than normal human response times. The low threshold may e.g. be 50 ms.
Authentication data may comprise a number of times that the sensation is generated by the sensation generator, and wherein the input authentication data comprises an input from the patient relating to a number of times the patient detected the sensation. Authenticating the connection may then comprise: upon determining that the number of times that the authentication data and the input authentication data are equal, authenticating the connection.
A method of authenticating the connection between an implantable pumping device 10 implanted in a patient, and an external device 320 according includes the following steps.
Generating, by a sensation generator 381, a sensation detectable by a sense of the patient. The sensation may comprise a plurality of sensation components. The sensation or sensation components may comprise a vibration (e.g. a fixed frequency mechanical vibration), a sound (e.g. a superposition of fixed frequency mechanical vibrations), a photonic signal (e.g. a non-visible light pulse such as an infra-red pulse), a light signal (e.g. a visual light pulse), an electric signal (e.g. an electrical current pulse) or a heat signal (e.g. a thermal pulse). The sensation generator may be implanted, configured to be worn in contact with the skin of the patient or capable of creating sensation without being in physical contact with the patient, such as a beeping alarm.
Sensations may be configured to be consistently felt by a sense of the patient while not risking harm to or affecting internal biological processes of the patient.
The sensation generator 381, may be contained within the controller 300 or be a separate entity connected to the controller 300. The sensation may be generated by a motor (denoted as M in several embodiments shown herein) of the implantable pumping device 10, wherein the motor being the sensation generator 381. The sensation may be a vibration, or a sound created by running the motor. The sensation generator 381 may be located close to a skin of the patient and thus also the sensory receptors of the skin. Thereby the strength of some signal types may be reduced.
Storing, by the controller 300, authentication data, related to the generated sensation.
Providing, by the patient input to the external device, resulting in input authentication data. Providing the input may e.g. comprise an engaging an electrical switch, using a biometric input sensor or entry into digital interface running on the external device 320 to name just a few examples.
Transmitting the input authentication data from the external device to the controller 300. If the step was performed, the analysis may be performed by the controller 300.
Transmitting the authentication data from the implantable pumping device 10 to the external device 320. If the step was performed, the analysis may be performed by the external device 320. The wireless connection WL1 or the conductive connection C1 may be used to transmit the authentication data or the input authentication data.
Authenticating the connection based on an analysis of the input authentication data and the authentication data e.g. by comparing a number of sensations generated and experienced or comparing timestamps of the authentication data and the input authentication data. If step was performed, the analysis may be performed by the implantable pumping device 10.
Communicating further data between the controller 300 and the external device 320 following positive authentication. The wireless connection WL1 or the conductive connection C1 may be used to communicate the further data. The further data may comprise data for updating a control program 310 running in the controller 300 or operation instructions for operating the implantable pumping device 10. The further data may also comprise data sensed by a sensor 150 connected to the controller 300.
If the analysis was performed by the controller 300, the external device 320 may continuously request or receive, information of an authentication status of the connection between the controller 300 and the external device 320, and upon determining, at the external device 320, that the connection is authenticated, transmitting further data from the external device 320 to the controller 300.
If the analysis was performed by the external device 320, the controller 300 may continuously request or receive, information of an authentication status of the connection between the controller 300 and the external device 320, and upon determining, at the controller 300, that the connection is authenticated, transmitting further data from the controller 300 to the external device 320.
A main advantage of authenticating a connection according to this method is that only the patient may be able to experience the sensation. Thus, only the patient may be able to authenticate the connection by providing authentication input corresponding to the sensation generation.
The sensation generator 381, sensation, sensation components, authentication data, input authentication data, and further data may be further described herein. In these cases, the implantable pumping device 10 and/or external device(s) comprises the necessary features and functionality (described in the respective sections of this document). Further information and definitions can be found in this document in conjunction with the other aspects.
The method may further comprise transmitting further data between the controller 300 and the external device, wherein the further data is used or acted upon, only after authentication of the connection is performed.
The analysis or step of analyzing may be understood as a comparison or a step of comparing.
In one method, increased security for communication between an external device(s) and an implanted controller is provided.
The controller 300 comprises a transceiver 308, 303 configured to establish a connection with an external device 320, i.e. with a corresponding transceiver 328, 323. The connection may be an electrical connection C1 using the transceivers 303, 323, or a wireless connection WL1 using the transceivers 308, 328. The controller 300 further comprises a computing unit 306 configured to verify the authenticity of instructions received at the transceiver 308, 303 from the external device 320. In this aspect, the concept of using previously transmitted instructions for verifying a currently transmitted instructions are employed. Consequently, the transmitting node (in this case the external device) need to be aware of previously instructions transmitted to the implant, which reduces the risk of a malicious device instructing the implant without having the authority to do so.
In an embodiment, the computing unit 306 is configured to verify the authenticity of instructions received at the transceiver 308, 303 by extracting a previously transmitted set of instructions from a first combined set of instructions received by the transceiver. The external device 320 may thus comprise an external device comprising a computing unit 326 configured for: combining a first set of instructions with a previously transmitted set of instructions, forming a combined set of instructions, and transmitting the combined set of instructions to the implant. The previously transmitted set of instructions, or a representation thereof, may be stored in memory 327 of the external device 320.
The combined set of instructions may have a data format which facilitates such extraction, for example including metadata identifying data relating to the previously transmitted set of instructions in the combined set of instructions. In some embodiments, the combined set of instructions comprises the first set of instructions and a cryptographic hash of the previously transmitted set of instructions. Consequently, the method comprises combining, at the external device, a first set of instructions with a previously transmitted set of instructions, forming a first combined set of instructions. A cryptographic hash function is a special class of hash function that has certain properties which make it suitable for use in cryptography. It is a mathematical algorithm that maps data of arbitrary size to a bit string of a fixed size (a hash) and is designed to be a one-way function, that is, a function which is infeasible to invert. Examples include MD5, SHA1, SHA 256, etc. Increased security is thus achieved.
The first combined set of instructions is then transmitted to the implanted controller 300, where it is received by e.g. the transceiver 303, 308. The first combined set of instructions may be transmitted to the implant using a proprietary network protocol. The first combined set of instructions may be transmitted to the controller 300 using a standard network protocol. In these cases, the controller 300 and/or external device(s) comprises the necessary features and functionality (described in the respective sections of this document) for performing transmission of data. By using different communication protocols, at the external device 320, for communication with the controller 300 and with a second external device 330, an extra layer of security is added as the communication between controller 300 and the external device 320 may be made less directly accessible to remote third parties.
At the controller 300, the computing unit 306 verifies the authenticity of the received first combined set of instructions, by: extracting the previously transmitted set of instructions from the first combined set of instructions, and comparing the extracted previously transmitted set of instructions with previously received instructions stored in the implant.
Upon determining that the extracted previously transmitted set of instructions equals the previously received instructions stored in the controller 300, the authenticity of the received first combined set of instructions may be determined as valid, and consequently, the first set of instructions may be safely run at the controller 300, and the first combined set of instructions may be stored in memory 307 of the controller 300, to be used for verifying a subsequent received set of instructions.
In some embodiments, upon determining by the internal computing unit 306 that the extracted previously transmitted set of instructions differs from the previously received instructions stored in the controller 300, feedback related to an unauthorized attempt to instruct the implantable pumping device 10 may be provided. For example, the transceiver 308, 303 may send out a distress signal to e.g. the external device 320 or to any other connected devices. The controller 300 may otherwise inform the patient that something is wrong by e.g. vibration or audio. The implantable pumping device 10 may be run in safe mode, using a preconfigured control program which is stored in memory 307 of the controller 300 and specifically set up for these situations, e.g. by requiring specific encoding to instruct the implantable pumping device 10, or only allow a predetermined device (e.g. provided by the manufacturer) to instruct the implantable pumping device 10. In some embodiments, when receiving such feedback at the external device 320, the external device 320 retransmits the first combined set of instructions again, since the unauthorized attempt may in reality be an error in transmission (where bits of the combined set of instructions are lost in transmission), and where the attempt to instruct the implantable pumping device 10 is indeed authorized.
The step of comparing the extracted previously transmitted set of instructions with previously received instructions stored in the controller 300 may be done in different ways. For example, the step of comparing the extracted previously transmitted set of instructions with previously received instructions stored in the controller 300 comprises calculating a difference between the extracted previously transmitted set of instructions with previously received instructions stored in the controller 300, and comparing the difference with a threshold value, wherein the extracted previously transmitted set of instructions is determined to equal the previously received instructions stored in the controller 300 in the case of the difference value not exceeding the threshold value. This embodiment may be used when received instructions is stored in clear text, or a representation thereof, in the controller 300, and where the combined set of instructions, transmitted from the external device also includes such a representation of the previously transmitted instructions. This embodiment may be robust against error in transmission where bits of information are lost or otherwise scrambled.
In other embodiments, the combined set of instructions comprises the first set of instructions and a cryptographic hash of the previously transmitted set of instructions, wherein the method further comprises, at the controller 300, calculating a cryptographic hash of the previously received instructions stored in the controller 300 and comparing the calculated cryptographic hash to the cryptographic hash included in the first combined set of instructions. This embodiment provides increased security since the cryptographic hash is difficult to decode or forge.
The above way of verifying the authenticity of received instructions at the controller 300 may be iteratively employed for further sets if instructions.
To further increase security, the transmission of a first set of instructions, to be stored at the controller 300 for verifying subsequent sets of combined instructions, where each set of received combined instructions will comprise data which in some form will represent, or be based on, the first set of instruction, may be performed.
In one example, the external device 320 may be adapted to communicate with the controller 300 using two separate communication methods. A communication range of a first communication method WL1 may be less than a communication range of a second communication method WL2. A method may comprise the steps of: sending a first part of a key from the external device 320 to the controller 300, using the first communication method WL1 and sending a second part of the key from the external device 320 to the controller 300, using the second communication method WL2. The method may further comprise deriving, in the controller 300, a combined key from the first part of the key and the second part of the key and decrypting the encrypted data, in the controller 300, using the combined key. The encrypted data may also be sent from the external device 320 to the controller 300 using the second communication method WL2. The method may then further comprise confirming an electrical connection C1 between the controller 300 and the external device 320 and as a result of the confirmation, decrypting the encrypted data in the controller 300 and using the decrypted data for instructing the controller 300.
The method may also comprise placing a conductive member 321, configured to be in connection with the external device 320, in electrical connection with a skin of the patient for conductive communication with the controller 300. By means of the electrical connection an extra layer of security is added as a potential hacker would have to be in contact with the patient to access or affect the operation of the implantable pumping device 10.
Using a plurality of communication methods, may increase the security of the authentication and the communication with the implantable pumping device 10 as more than one channel for communication may need to be hacked or hijacked by an unauthorized entity to gain access to the implantable pumping device 10 or the communication.
The electrical connection C1 the conductive member 321 and conductive communication may be further described herein in the general definitions section. In these cases, the controller 300 and/or external device 320 comprise the necessary features and functionality (described in the respective sections of this document).
It should also be noted that any one of the first and second communication methods WL1, WL2 may be needed to be confirmed in order to decrypt the encrypted data in the controller 300 and using the decrypted data for instructing the implantable pumping device 10.
The method may further comprise the step of wirelessly receiving, at the controller 300, a third part of the key from the second external device 330. In this case, the combined key may be derived from the first part of the key, the second part of the key and the third part of the key.
The first communication method WL1 may be a wireless form of communication. The first communication method WL1 may preferably be a form of electromagnetic or radio-based communication however, other forms of communication are not excluded. The first communication method WL1 may comprise or be related to the items of the following list: Radio-frequency identification (RFID), Bluetooth, Bluetooth 5, Bluetooth Low Energy (BLE), Near Field Communication (NFC), NFC-V, Infrared (IR) based communication, Ultrasound based communication.
RFID communication may enable the use of a passive receiver circuit such as those in a RFID access/key or payment card. IR based communication may comprise fiber optical communication and IR diodes. IR diodes may alternatively be used directly, without a fiber, such as in television remote control devices. Ultrasound based communication may be based on the non-invasive, ultrasound imaging found in use for medical purposes such as monitoring the development of mammal fetuses.
The first communication method WL1 may use a specific frequency band. The frequency band of the first communication method WL1 may have a center frequency of 13.56 MHz or 27.12 MHz. These bands may be referred to as industrial, scientific and medical (ISM) radio bands. Other ISM bands not mentioned here may also be utilized for the communication methods WL1, WL2. A bandwidth of the 13.56 MHz centered band may be 14 kHz and a bandwidth of the 27.12 MHz centered band may be 326 kHz.
The communication range of the first communication method WL1 may be less than 10 meters, preferably less than 2 meters, more preferably less than 1 meter and most preferably less than 20 centimeters. The communication range of the first communication method WL1 may be limited by adjusting a frequency and/or a phase of the communication. Different frequencies may have different rates of attenuation. By implementing a short communication range of the first communication method, security may be increased since it may be ensured or made probable that the external device is under control of the patient (holding the external device close to the implant)
The communication range of the first communication method WL1 should be evaluated by assuming that a patient's body, tissue, and bones present the propagation medium. Such a propagation medium may present different attenuation rates as compared to a free space of an air-filled atmosphere or a vacuum.
By restricting the communication range, it may be established that the external device communicating with the implanted controller 300 is in fact on, or at least proximal to, the patient. This may add extra security to the communication.
The second communication method WL2 may be a wireless form of communication. The second communication method WL2 may preferably be a form of electromagnetic or radio-based communication. The second communication method WL2 may be based on telecommunication methods. The second communication method WL2 may comprise or be related to the items of the following list: Wireless Local Area Network (WLAN), Bluetooth, Bluethooth 5, BLE, GSM or 2G (2nd generation cellular technology), 3G, 4G, 5G, 6G.
The second communication method WL2 may utilize the ISM bands as mentioned in the above for the first communication method WL1.
A communication range of the second communication method WL2 may be longer than the communication range of the first communication method WL1. The communication range of the second communication method WL2 may preferably be longer than 10 meters, more preferably longer than 50 meters, and most preferably longer than 100 meters.
Encrypted data may comprise instructions for updating a control program 310 running in the implantable pumping device 10. Encrypted data may further comprise instructions for operating the implantable pumping device 10.
In one embodiment, the implantable pumping device 10 may transmit data to an external device 320 which may add an additional layer of encryption and transmit the data to a second external device 330, described with reference to
Thus, in an embodiment, a system is provided. The system comprises an implantable pumping device 10 comprising a controller 300 configured to transmit data from the body of the patient to an external device 320, and an encryption unit 382 for encrypting the data to be transmitted. The system further comprises an external device 320 configured to receive the data transmitted by the controller 300, encrypt the received data using a first key and transmit the encrypted received data to a third external device 330. The encryption can be performed using any of the keys described above or below. In some embodiments, the external device 320 is configured to decrypt the data received from the controller 300 before encrypting and transmitting the data. Alternatively, the external device 320 may encrypt and transmit the data received from the controller 300 without decrypting it first.
In one example, the encryption unit 382 is configured to encrypt the data to be transmitted using a second key. The first key or the second key may, for example, information specific to the implantable pumping device 10, a secret key associated with the external device 320, an identifier of the implantable pumping device 10 or an identifier of the controller 300. The second key could be a key transmitted by the external device 320 to the controller 300. In some examples, the second key is a combined key comprising a third key received by the controller 300 from the external device 320.
The first key may be a combined key comprising a fourth key, wherein the fourth key is received by the external device 320 from a fourth device. The fourth device may be a verification unit, either comprised in the external device, or external to the external device and connected to it. The verification unit may have a sensor 350 for verification, such as a fingerprint sensor. More details in regard to this will be described below. Alternatively, the verification unit may be a generator, as described above.
The system may be configured to perform a method for transmitting data using a sensed parameter. The method may comprise transmitting a parameter measured by the external device 320 from the external device 320 to the controller 300. In this case, the comparison of the parameter of the patient measured by the external device 320 and the parameter of the patient measured by the controller 300 may be performed by the controller 300. The implantable pumping device 10 may comprise a first sensor 150 for measuring the parameter of the patient at the implantable pumping device 10. The external device 320 may comprise an external sensor 350 for measuring the parameter of the patient at the external device 320.
Authentication of the connection between the controller 300 and the external device 320 may be performed automatically without input, authentication, or verification from a user or patient. This is because the comparison of parameters measured internally and externally, by the internal and external sensors 351, 350 respectively may be enough to authenticate the connection. This may typically be the case when the parameter of the patient is related to an automatically occurring physiological function of the patient such as e.g. a pulse of the patient. Certain types of authentication may however require actions from the patient, e.g. having the patient perform specific movements.
In the embodiments described herein, the controller 300 may comprise or be connected to a sensation generator 381 as described above. In response to an event in the implant, such as a reset, a restart, receipt of new instructions, receipt of a new configuration or update, installation or activation of new instructions or configuration or update, the controller 300 may be configured to cause the sensation generator 381 to generate a sensation detectable by the patient in which the implantable pumping device 10 is implanted. In some examples, the user may after the sensation verify an action, for example via a user interface of an external device 320.
The implantable pumping device 10 may further implement a method for improving the security of the data transmitted from the controller 300. The method, for encrypted communication between a controller 300, when implanted in a patient's body, and an external device 320, comprises encoding or encrypting, by the controller 300 or a processor 306 comprised in or connected to the controller 300, data relating to the implantable pumping device 10 or the operation thereof; transmitting, by the controller 300, the data; receiving, by a second communication unit comprised the external device 320, the data; encrypting, by the external device 320, the data using an encryption key to obtain encrypted data; and transmitting the encrypted data to a third external device 330. In this way, the external device 320 may add or exchange the encryption, or add an extra layer of encryption, to the data transmitted by the controller 300. When the controller 300 encodes the data to be transmitted it may be configured to not encrypt the data before transmitting, or only using a light weight encryption, thus not needing as much processing power as if the controller were to fully encrypt the data before the transmission.
The encrypting, by the controller 300, may comprise encrypting the data using a second key. The encryption using the second key may be a more light weight encryption than the encryption performed by the external device using the second key, i.e. an encryption that does not require as much computing resources as the encryption performed by the external device 320.
The first or the second key may comprise a private key exchanged as described above with reference to encryption and authentication, or the first or the second key may comprise an information specific to the implantable pumping device 10, a secret key associated with the external device, an identifier of the implantable pumping device 10 or an identifier of the controller 300. They may be combined keys as described in this description, and the content of the keys, any combination of keys, and the exchange of a key or keys is described in the encryption and/or authentication section.
In an embodiment, the implantable pumping device 10 comprises at least one sensor for sensing at least one physiological parameter of the patient or a functional parameter of the implantable pumping device 10, now described with reference to
The controller of the implant may be connected to the sensor 351 and be configured to anonymize the information before it is transmitted. The transmission of data may also be called broadcasting of data.
In addition to or as an alternative to transmitting the data when the sensed parameter is above a predetermined threshold, the controller 300 may be configured to broadcast the information periodically. The controller 300 may be configured to broadcast the information in response to a second parameter being above a predetermined threshold. The second parameter may, for example, be related to the controller 300 itself, such as a free memory or free storage space parameter, or a battery status parameter. When the implantable pumping device 10 comprises an implantable energy storage unit and an energy storage unit indicator, the energy storage unit indicator is configured to indicate a functional status of the implantable energy storage unit and the indication may be comprised in the transmitted data. The functional status may indicate at least one of charge level and temperature of the implantable energy storage unit.
In some embodiments the external device 320 is configured to receive the broadcasted information, encrypt the received information using an encryption key and transmit the encrypted received information. In this way, the external device 320 may add an additional layer of encryption or exchange the encryption performed by the controller 300.
In an embodiment, the controller 300 is configured to transmit the data using the body of the patient as a conductor C1, and the external device 320 is configured to receive the data via the body. Alternatively, or in combination, the controller 300 of the implant is configured to transmit the data wirelessly to the external device WL2.
Thus, the controller 300 may implement a method for transmitting data from the controller 300 comprising a processor 306, comprising: obtaining sensor measurement data via a sensor 150 connected to or comprised in the controller 300, the sensor measurement relating to at least one physiological parameter of the patient or a functional parameter of the implantable pumping device 10, and transmitting by the controller 300 the sensor measurement data in response to the sensor measurement being above a predetermined threshold, wherein the sensor 150 is configured to periodically sense the parameter. The method may further comprise broadcasting the sensor measurement data, to be received by an external device 320. The transmitting or broadcasting may comprise using at least one of a Radio Frequency type protocol, RFID type protocol, WLAN type protocol, Bluetooth type protocol, BLE type protocol, NFC type protocol, 3G/4G/5G/6G type protocol, or a GSM type protocol.
The method may further comprise, at the processor 306, anonymizing, by the processor, the sensor measurement data before it is transmitted, or encrypting the sensor measurement data, using an encryptor 382 comprised in the processing unit 306, before it is transmitted. The transmitting of the data may further comprise to encode the data before the transmitting. The type of encoding may be dependent on the communication channel or the protocol used for the transmission.
The transmitting may be performed periodically, or in response to a signal received by the processor, for example, by an internal part of the implantable pumping device 10 such as a sensor 150, or by an external device 320.
The parameter may, for example, be at least one of a functional parameter of the implantable pumping device 10 (such as a battery parameter, a free memory parameter, a temperature, a pressure, an error count, a status of any of the control programs, or any other functional parameter mentioned in this description) or a parameter relating to the patient (such as a temperature, a blood pressure, or any other parameter mentioned in this description). In one example, the implantable pumping device 10 comprises an implantable energy storage unit 40 and an energy storage unit indicator 304c, and the energy storage unit indicator 304c is configured to indicate a functional status of the implantable energy storage unit 40, and the sensor measurement comprises data related to the energy storage unit indicator.
In one example, the transmitting comprises transmitting the sensor measurement to an internal processor 306 configured to cause a sensation generator 381 to cause a sensation detectable by the patient in which the implant 100 is implanted.
The method may be implemented in a system comprising the implant 100 and an external device 320, and further comprise receiving the sensor measurement data at the external device 320, and, at the external device 320, encrypting the sensor measurement data using a key to obtain encrypted data, and, transmitting the encrypted data. The transmitting may, for example, be performed wirelessly WL3 or conductively C1.
In the examples or embodiments transmitting data from or to the implantable pumping device 10, the following method may be implanted in order to verify the integrity of the data, described with reference to
Thus, in a first example, a method for evaluating a parameter of a controller 300 implanted in a patient is described. The controller 300 comprises a processor 306 and a sensor 150 for measuring the parameter. The method comprises measuring, using the sensor 150, the functional parameter to obtain measurement data; establishing a connection between the internal controller 300 and an external device 320 configured to receive data from the implant; determining, by the processor 306, a cryptographic hash or a metadata relating to the measurement data and adapted to be used by the external device 320 to verify the integrity of the received data; transmitting the cryptographic hash or metadata; and transmitting, from the controller 300, the measurement data.
The parameter may, for example, be a parameter of the controller 300, such as a temperature, a pressure, a battery status indicator, a time period length, s pressure at a restriction device, a pressure at a sphincter, or a physiological parameter of the patient, such as a pulse, a blood pressure, or a temperature. In some examples, multiple parameters may be used.
The method may further comprise evaluating the measurement data relating to the functional parameter. By evaluating it may be meant to determine if the parameter is exceeding or less than a predetermined value, to extract another parameter from the measurement data, compare the another parameter to a predetermined value, or displaying the another parameter to a user. For example, the method may further comprise, at the external device 320, to determining, based on the evaluating, that the implantable pumping device 10 is functioning correctly, or determining based on the evaluating that the implantable pumping device 10 is not functioning correctly.
If it is determined that the implantable pumping device 10 is not functioning correctly, the method may further comprise sending, from the external device 320, a corrective command to the controller 300, receiving the corrective command at the controller 300, and by running the corrective command correcting the functioning of the implantable pumping device 10 according to the corrective command.
The method may further comprise, at the external device 320, receiving the transmitted cryptographic hash or metadata, receiving the measurement data, and verifying the integrity of the measurement data using the cryptographic hash or metadata. The cryptographic hash algorithm be any type of hash algorithm, i.e. an algorithm comprising a one-way function configured to have an input data of any length as input and produce a fixed-length hash value. For example, the cryptographic hash algorithm may be MD5, SHA1, SHA 256, etc.
In some examples, the cryptographic hash is a signature obtained by using a private key of the controller 300, and wherein the verifying, by the external device 320, comprises verifying the signature using a public key corresponding to the private key.
When using a cryptographic hash, the method may further comprise calculating a second cryptographic hash for the received measurement data using a same cryptographic hash algorithm as the processor, and determining that the measurement data has been correctly received based on that the cryptographic hash and the second cryptographic hash are equal (i.e. have the same value).
When using a metadata the verifying the integrity of the data may comprises obtaining a second metadata for the received measurement data relating to the functional parameter, and determining that the data has been correctly received based on that metadata and the second metadata are equal. The metadata may, for example, be a length of the data or a timestamp. In some examples the measurement data is transmitted in a plurality of data packets. In those examples, the cryptographic hash or metadata comprises a plurality of cryptographic hashes or metadata each corresponding to a respective data packet, and the transmitting of each the cryptographic hashes or metadata is performed for each of the corresponding data packets.
A similar method may be utilized for communicating instructions from an external device 320 to a controller 300 implanted in a patient. The method comprises establishing a first connection between the external device 320 and the controller 300, establishing a second connection between a second external device 330 and the controller 300, transmitting, from the external device 320, a first set of instructions to the controller 300 over the first connection, transmitting, from the second external device 330, a first cryptographic hash or metadata corresponding to the first set of instructions to the controller 300, and, at the controller 300, verifying the integrity of the first set of instructions and the first cryptographic hash or metadata, based on the first cryptographic hash or metadata. The external device 320 may be separate from the second external device 330.
The first connections may be established between the controller 300 and a transceiver of the external communication unit 323. In some examples, the communication using the second connection is performed using a different protocol than a protocol used for communication using the first communication channel. In some examples, the first connection is a wireless connection and the second connection is an electrical connection. The second connection may, for example, be an electrical connection using the patient's body as a conductor (using 321). The protocols and ways of communicating may be any communication protocols described in this description with reference to C1, and WL1-WL4. The establishing of the first and second connections are performed according to the communication protocol used for each of the first and the second connections.
When using a cryptographic hash, the verifying the integrity of the first set of instructions may comprise calculating a second cryptographic hash for the received first set of instructions using a same cryptographic hash algorithm as the processor 306, and determining that the first set of instructions has been correctly received based on that the cryptographic hash and the second cryptographic hash are equal. The cryptographic hash may, for example, be a signature obtained by using a private key of the implantable pumping device 10, and wherein the verifying comprises verifying the signature using a public key corresponding to the private key. In some examples, the cryptographic hash is a signature obtained by using a private key of the implantable pumping device 10, and wherein the verifying comprises verifying the signature using a public key corresponding to the private key. The private keys and public keys, as well as the exchange or transmittal of keys have been described in this description. Alternatively, other well-known methods can be used for transmitting or exchanging a key or keys between the external device 320 and the controller 300.
When using a metadata, and wherein the verifying the integrity of the data may comprise obtaining a second metadata for the received first set of instructions, and determining that the first set of instructions has been correctly received based on that metadata and the second metadata are equal. The metadata may, for example, be any type of data relating to the data to be transmitted, in this example the first set of instructions. For example, the metadata may be a length of the data to be transmitted, a timestamp on which the data was transmitted or retrieved or obtained, a size, a number of packets, or a packet identifier.
In some examples, the controller 300 may transmit data to an external device 320 relating to the data information in order to verify that the received data is correct. The method may thus further comprise, transmitting, by the controller 300, information relating to the received first set of instructions, receiving, by the external device 320, the information, and verifying, by the external device 320, that the information corresponds to the first set of instructions sent by the external device 320. The information may, for example, comprise a length of the first set of instructions.
The method may further comprise, at the controller 300, verifying the authenticity of the first set of instructions by i. calculating a second cryptographic hash for the first set of instructions, ii. comparing the second cryptographic hash with the first cryptographic hash, iii. determining that the first set of instructions are authentic based on that the second cryptographic hash is equal to the first cryptographic hash, and upon verification of the authenticity of the first set of instructions, storing them at the controller 300.
In some examples, the first set of instructions comprises a cryptographic hash corresponding to a previous set of instruction, as described in other parts of this description.
In some examples, the first set of instructions may comprise a measurement relating to the patient of the body for authentication, as described in other parts of this description.
A system and a method for communication of instructions or control signals between an external device 320 and an implant 10 will now be described with reference to
The system shown in
The first external device 320 is adapted to receive, such as through a user interface, or determine an instruction to be transmitted to the implant 10. The determination of the instruction may, for example, be based on received data from the implantable pumping device 10, such as measurement data or data relating to a state of the implant, such as a battery status or a free memory status. The first external device 320 may be any type of device capable of transmitting information to the implant and capable of determining or receiving an instruction to be transmitted to the implantable pumping device 10. In a preferred embodiment, the first external device 320 is a hand-held device, such as a smartphone, smartwatch, tablet etc. handled by the patient, having a user interface for receiving an instruction from a user, such as the patient or a caregiver.
The first external device 320 is further adapted to transmit the instruction to a second external device 330 via communication channel WL3. The second external device 320 is adapted to receive the instruction, encrypt the instruction using an encryption key, and then transmit the encrypted instruction to the implantable pumping device 10. The implantable pumping device 10 is configured to receive the instruction at the controller 300. The controller 300 thus comprises a wired transceiver or a wireless transceiver for receiving the instruction. The implantable pumping device 10 is configured to decrypt the received instruction. The decryption may be performed using a decryption key corresponding to the encryption key. The encryption key, the decryption key and methods for encryption/decryption and exchange of keys may be performed as described in the “general definition of features” or as described with reference to
The second external device 330 may be any computing device capable of receiving, encrypting and transmitting data as described above. For example, the second external device 320 may be a network device, such as a network server, or it may be an encryption device communicatively coupled to the first external device.
The instruction may be a single instruction for running a specific function or method in the implantable pumping device 10, a value for a parameter of the implantable pumping device 10, or a set of sub-steps to be performed by the controller 300 comprised in the implant.
In this way, the instruction for controlling a function of the implantable pumping device 10 may be received at the first external device 320 and transmitted to the implant 10 via the second external device 330. By having a second external device 330 encrypting the instruction before transmitting it to the implantable pumping device 10, the instruction may be verified by the second external device 330 and the first external device 320 may function so as to relay the instruction. In some alternatives, the second external device 330 may transmit the instruction directly to the implantable pumping device 10. This may provide an increased security as the instruction sent to the implantable pumping device 10 may be verified by the second external device 330, which, for example, may be a proprietary device managed by the medical professional responsible for the implantable pumping device 10. Further, by having the second medical device 330 verifying and encrypting the instruction, the responsibility authenticity and/or correctness of the instruction may lie with the second external device 330, which may be beneficial for regulatory purposes, as the first external device 320 may not be considered as the instructor of the implantable pumping device 10.
Further, the second external device 330 may verify that the instruction is correct before encrypting or signing and transmitting it to the implantable pumping device 10. The second external device 330 may, for example, verify that the instruction is correct by comparing the instruction with a predetermined set of instructions, and if the instruction is comprised in the predetermined set of instructions determine that the instruction is correct. If the instruction comprises a plurality of sub-steps, the second external device 330 may determine that the instruction is correct if all the sub-steps are comprised in the predetermined set of instructions. If the instruction comprises a value for a parameter of the implantable pumping device 10, the second external device 330 may verify that the value is within a predetermined range for the parameter. The second external device 320 may thus comprise a predetermined set of instructions, or a predetermined interval or threshold value for a value of a parameter, stored at an internal or external memory.
The second external device 330 may be configured to reject the instruction, i.e. to not encrypt and transmit the instruction to the implantable pumping device 10, if the verification of the instruction would fail. For example, the second external device 330 determines that the instruction or any sub-step of the instruction is not comprised in the predetermined set of instructions, or if a value for a parameter is not within a predetermined interval, the second external device 330 may determine that the verification has failed.
In some embodiments, the implantable pumping device 10 may be configured to verify the instruction. The verification of the instruction may be performed in the same way as described with reference to
In an alternative to encrypting and decrypting the instruction, the instruction may be signed by the second external device 330 using a cryptographic hash, and the controller 300 may be configured to verify that the signature is correct before running the instruction.
A corresponding method for transmitting an instruction will now be described with reference to
The instruction may be any type of instruction for controlling a function of the implantable pumping device. For example, the instruction may be an instruction to run a function or method of the implantable pumping device 10 or controller 300, an instruction comprising a plurality of sub-steps to be run at the controller 300, or a value for a parameter at the controller 300. The first external device 320 may, for example, receive the instruction from a user via a user interface displayed at or connected to the first external device 320. In another example, the first external device 320 may determine the instruction in response to data received from the implantable pumping device 10, such as measurement data, or from another external device. Thus, in some examples, the method may further comprise receiving, at the first external device 320, an instruction to be transmitted to the implantable pumping device 10. The method may further comprise displaying a user interface for receiving the instruction. In another example, the method comprises determining, at the first external device 320, an instruction to be transmitted to the implantable pumping device 10.
In some embodiments, the transmitting of the encrypted instruction from the second external device 330 to the implantable pumping device 10 comprises transmitting the encrypted instruction from the second external device 330 to the first external device 320, and transmitting the encrypted instruction from the first external device 320 to the controller 300 of the implantable pumping device 10. In other words, the first external device 320 may relay the encrypted instruction from the second external device 330 to the controller 300, preferably without decrypting the instruction before transmitting it.
The method may further comprise to, at the controller 300, running the instruction or performing the instruction. The running of the instruction may be performed by an internal computing unit or a processor 306 comprised in the controller 300, and may, for example, cause the internal computing unit or processor 306 to instruct the implantable restriction device 302 to perform an action.
The method may further comprise verifying, at the second external device 330, that the instructions are correct. The verifying may be performed as described above with reference to the corresponding system.
The method may further comprise verifying, at the controller 300, that the instructions are correct. The verifying may be performed as described above with reference to the corresponding system.
The method may further comprise authenticating the connection between the first external device 320 and the controller 300 over which the encrypted instruction is to be transmitted. The authentication may be performed as described herein.
As described above, a control program of the controller 300 may be updatable, configurable or replaceable. A system and a method for updating or configuring a control program of the controller 300 is now described with reference to
The predefined program steps may comprise setting a variable related to a pressure, a time, a minimum or maximum temperature, a current, a voltage, an intensity, a frequency, an amplitude of electrical stimulation, a feedback mode (sensorics or other), a post-operative mode or a normal mode, a catheter mode, a fibrotic tissue mode (for example semi-open), an time open after urination, a time open after urination before bed-time.
The verification function may be configured to reject the update in response to the update comprising program steps not comprised in the set of predefined program steps and/or be configured to allow the update in response to the update only comprising program steps comprised in the set of predefined program steps.
The internal computing unit 306 may be configured to install the update in response to a positive verification, for example by a user using an external device, by a button or similarly pressed by a user, or by another external signal.
The authentication or verification of communications between the implant and an external device has been described above.
When updating a control program of the controller 300, it may be beneficial to transmit a confirmation to a user or to an external device or system. Such a method is now described with reference to
The method for updating a control program of a controller 300 comprised in the implantable pumping device 10 according to any of the embodiments herein. The controller 300 is adapted for communication with a first external device 320 and a second external device 330, which may comprise receiving, by the internal computing unit, an update or configuration to the control program from the first external device, wherein the update is received using a first communication channel; installing, by the internal computing unit 306, the update; and transmitting, by the internal computing unit, logging data relating to the receipt of the update or configuration and/or logging data relating to an installation of the update to the second external device 330 using the second communication channel; wherein the first and the second communication channels are different communication channels. By using a first and a second communication channels, in comparison to only using one, the security of the updating may be improved as any attempts to update the control program will be logged via the second communication channel, and thus, increasing the chances of finding incorrect or malicious update attempts.
The update or configuration comprises a set of instructions for the control program, and may, for examples comprise a set of predefined program steps as described above. The configuration or update may comprise a value for a predetermined parameter.
In some examples, the method further comprises confirming, by a user or by an external control unit, that the update or configuration is correct based on the received logging data.
The logging data may be related to the receipt of the update or configuration, and the controller 300 is configured to install the update or configuration in response to receipt of a confirmation that the logging data relates to a correct set of instructions. In this way, the controller 300 may receive data, transmit a logging entry relating to the receipt, and then install the data in response to a positive verification that the data should be installed.
In another example, or in combination with the one described above, the logging data is related to the installation or the update or configuration. In this example the logging data may be for information purposes only and not affect the installation, or the method may further comprise activating the installation in response to the confirmation that the update or configuration is correct.
If the update or configuration is transmitted to the controller 300 in one or more steps, the verification as described above may be performed for each of the steps.
The method may further comprise, after transmitting the logging data to the second external device, verifying the update via a confirmation from the second external device 330 via the second communication channel.
With reference to
The implantable controller is placed in an implantable housing for sealing against fluid, and the microphone sensor 351 is placed inside of the housing. Accordingly, the controller and the microphone sensor 351 do not come into contact with bodily fluids when implanted which ensures proper operation of the controller and the microphone sensor 351.
In some implementations, the computing unit 306 is configured to derive information related to the functional status of an active unit 302 of the implantable pumping device 10, from the registered sound related to a function of the implantable pumping device 10. Accordingly, the computing unit 306 may be configured to derive information related to the functional status of at least one of: a motor, a pump and a transmission of the active unit 302 of the implantable pumping device 10, from the registered sound related to a function of the implantable pumping device 10.
The controller may comprise a transceiver 303,308 configured to transmit a parameter derived from the sound registered by the at least one microphone sensor 351 using the transceiver 303,308. For example, the transceiver 303,308 is a transceiver configured to transmit the parameter conductively (303) to an external device 320 or wirelessly (308) to an external device 320.
A method of authenticating the implantable pumping device 10, the external device 320 or a communication signal or data stream between the external device 320 and the implantable pumping device 10 is also described with reference to
According to one embodiment described with reference to
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The physical or functional parameter of the implanted system 10 could comprise at least one of a current setting or value of the vessel member 100, a prior instruction sent to the implantable system 10 or an ID of the implanted system 10.
The portion of the message comprising the information related to the physiological parameter of the patient and/or physical or functional parameter of the implanted system 10 could be encrypted, and the central unit 306 may be configured to transmit the encrypted portion to the security module 389 and receive a response communication from the security module 389 based on the information having been decrypted by the security module 389.
In the embodiment shown in
In alternative embodiments, the security module 389 is a software security module comprising at least one software-based key, or a combination of a hardware and software-based security module and key. The software-based key may correspond to a software-based key in the external device 320. The software-based key may correspond to a software-based key on a key-card connectable to the external device 320.
In the embodiment shown in
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The wireless transceiver 308 is configured to communicate wirelessly with the external device 320 using a first communication protocol and the central unit 306 is configured to communicate with the security module 389 using a second, different, communication protocol. This adds an additional layer of security as security structures could be built into the electronics and/or software in the central unit 306 enabling the transfer from a first to a second communication protocol. The wireless transceiver 308 may be configured to communicate wirelessly with the external device using a standard network protocol, which could be one of an RFID type protocol, a WLAN type protocol, a Bluetooth (BT) type protocol, a BLE type protocol, an NFC type protocol, a 3G/4G/5G type protocol, and a GSM type protocol. In the alternative, or as a combination, the wireless transceiver 308 could be configured to communicate wirelessly with the external device 320 using a proprietary network protocol. The wireless transceiver 308 could comprises a Ultra-Wide Band (UWB) transceiver and the wireless communication between the implantable controller 300 and the external device 320 could thus be based on UWB. The use of UWB technology enables positioning of the external device 320 which can be used by the implanted system 10 as a way to establish that the external device 320 is at a position which the implanted system 10 and/or the patient can acknowledge as being correct, e.g. in the direct proximity to the implanted system 10 and/or the patient, such as within reach of the patient and/or within 1 or 2 meters of the implanted system 10. In the alternative, a combination of UWB and BT could be used, in which case the UWB communication can be used to authenticate the BT communication, as it is easier to transfer large data sets using BT.
According to one embodiment described with reference to
The first switch 195a is placed at a first end portion 192a of the coil 192, and the receiving unit 305 further comprises a second switch 195b placed at a second end portion of the coil 192, such that the coil 192 can be completely disconnected from other portions of the implantable system 10. The receiving unit 305 is configured to receive transcutaneously transferred energy in pulses according to a pulse pattern. The measurement unit 194 is in the embodiment shown in
The variable impedance 193 may comprise a resistor and a capacitor and/or a resistor and an inductor and/or an inductor and a capacitor. The variable impedance 193 may comprise a digitally tuned capacitor or a digital potentiometer. The variable impedance 193 may comprise a variable inductor. The first and second switch comprises a semiconductor, such as a MOSFET. The variation of the impedance is configured to lower the active power that is received by the receiving unit. As can be seen in
Embodiments relating to an implantable pumping device 10 having a controller 300 having a processor 306 with a sleep mode and an active mode will now be described with reference to
In an embodiment in which the controller 300 comprises a processor 306 having a sleep mode and an active mode, the controller 300 comprises or is connected to a sensor 150 and a processing unit 306 having a sleep mode and an active mode. The sensor 150 is configured to periodically measure a physical parameter of the patient, and the controller 300 is further configured to, in response to a sensor measurement preceding a predetermined value, setting the processing unit 306 in an active mode. That is, the controller 300 may “wake up” or be set in an active mode in response to a measurement from, for example, the body. A physical parameter of the patient could for example be a local or systemic temperature, saturation/oxygenation, blood pressure or a parameter related to an ischemia marker such as lactate.
By sleeping mode it is meant a mode with less battery consumption and/or processing power used in the processing unit 306, and by “active mode” it may be meant that the processing unit 306 is not restricted in its processing.
The sensor 150 may, for example, be a pressure sensor. The pressure sensor may be adapted to measure a pressure in an organ of a patient, a reservoir of the implant or a restriction device of the active unit 302. The sensor 150 may be an analog sensor or a digital sensor, i.e. a sensor 150 implemented in part in software. In some examples, the sensor is adapted to measure one or more of a battery or energy storage status of the implantable pumping device 10 and a temperature of the implantable pumping device 10. In this way, the sensor 150 may periodically sense a pressure of the implantable pumping device 10 or of the patient, and set the processing unit 306 in an active mode if the measured pressure is above a predetermined value. Thus, less power, i.e. less of for example a battery or energy storage comprised in the implant, may be used, thereby prolonging the lifetime of the implantable pumping device 10 or increasing the time between charging occasions of the implantable pumping device 10.
In some examples, the processor 306, when in set in the active mode, may cause a sensation generator 381 connected to the implant, comprised in the implantable pumping device 10 or comprised in an external device 320, 330, to generate a sensation detectable by a sense of the patient. For example, the processor may cause the sensation generator to generate a sensation in response to a measure battery status, for example that the battery is above or below a predetermined level, that a measured pressure is above or below a predetermined level, or that another measured parameter has an abnormal value, i.e. less than or exceeding a predetermined interval or level. The sensation generator has been described in further detail earlier in this description.
The processing unit 306 may be configured to perform a corrective action in response to a measurement being below or above a predetermined level. Such a corrective action may, for example, be increasing or decreasing a pressure, increasing or decreasing electrical stimulation, increasing or decreasing power.
The controller 300 may comprise a signal transmitter 320 connected to the processing unit, and wherein the processing unit is configured to transmit data relating to the measurement via the transceiver 308 of the controller 300 or an additional internal signal transmitter 392. The transmitted data may be received by an external device 320.
The external device may have an external communication unit 390. The external device 320 may comprise a signal provider 380 for providing a wake signal to the controller 300. In some examples, the signal provider comprises a coil or magnet 371 for providing a magnetic wake signal.
The controller 300 may implement a corresponding method for controlling an implantable pumping device 10 when implanted in a patient. The method comprises measuring, with a sensor of the controller 300 connected to or comprised in the controller 300, a physiological parameter of the patient or a parameter of the implantable pumping device 10, and, in response to a sensor measurement having an abnormal value, setting, by the controller 300, a processor 306 of the controller 300 from a sleep mode to an active mode. The measuring may be carried out periodically. By “abnormal value” it may be meant a measured value exceeding or being less than a predetermined value, or a measured value being outside a predetermined interval. The method may further comprise generating, with a sensation generator 381 as described above, a sensation detectable by the patient. In some examples, the generating comprises requesting, by the processor, the sensation generator 381 to generate the sensation.
The method may further comprise to perform a medical intervention in response to a sensor measurement having an abnormal value, preferably after the processing unit has been set in the active mode.
A system comprising an implantable pumping device 10 having a controller 300 having a sleep mode and an active mode will now be described with reference to
The sensor 150 may, for example, be a hall effect sensor, a fluxgate sensor, an ultra-sensitive magnetic field sensor, a magneto-resistive sensor, an AMR or GMR sensor, or the sensor may comprise a third coil having an iron core.
The magnetic field provider 380 may have an off state, wherein it does not provide any magnetic field, and an on state, wherein it provides a magnetic field. For example, the magnetic field provider 380 may comprise a magnet 371, a coil 371, a coil having a core 371, or a permanent magnet 371. In some embodiments, the magnetic field provider 380 may comprise a shielding means for preventing a magnet 371 or permanent magnet 371 from providing a magnetic field in the off state. In order to provide a substantially even magnetic field, the magnetic field provider may comprise a first and a second coil arranged perpendicular to each other.
After the processing unit 306 has been set in an active mode, i.e. when the processing unit 306 has been woken, the implant may determine a frequency for further communication between the controller 300 and the external device 320. The controller 300 may thus comprise a frequency detector 391 for detecting a frequency for communication between the controller 300 and the second communication unit 390. The frequency detector 391 is, for example, an antenna. The external device 320 may comprise a frequency indicator 372, for transmitting a signal indicative of a frequency. The frequency indicator 372, may, for example, be a magnetic field provider capable of transmitting a magnetic field with a specific frequency. In some examples the frequency indicator is comprised in or the same as the magnetic field provider 371. In this way, the frequency signal is detected using means separate from the sensor, and can, for example, be detected using a pin on a chip.
Alternatively, the controller 300 and the external device 320 may communicate using a predetermined frequency or a frequency detected by means defined by a predetermined method according to a predetermined protocol to be used for the communication between the controller 300 and the external device 320.
In some embodiments, the sensor 150 may be used for the communication. The communication may in these embodiments be performed with such that a frequency of the magnetic field generated by the coil is 9-315 kHz, or the magnetic field generated by the coil is less than or equal to 125 kHz, preferably less than 58 kHz. The frequency may be less than 50 Hz, preferably less than 20 Hz, more preferably less than 10 Hz, in order to be transmittable through a titan box.
In some embodiments, the controller 300 comprises a receiver unit 392, and the internal control unit and the external control unit are configured to transmit and/or receive data via the receiver unit 392 via magnetic induction. The receiver unit 392 may comprise a high-sensitivity magnetic field detector, or the receiver unit may comprise a fourth coil for receiving the magnetic induction.
The system may implement a method for controlling a medical implant implanted in a patient. The method comprises monitoring for signals by a sensor 150 comprised in the controller 300 communicatively coupled to the active unit 302, providing, from a signal provider 380 comprised in an external device 320, a wake signal, the external device 320 being adapted to be arranged outside of the patient's body, and setting, by the controller 300 and in response to a detected wake signal WS, a mode of a processing unit 306 comprised in the internal control unit from a sleep mode to an active mode.
The method may also comprise detecting, using a frequency detector 391, a frequency for data communication between the controller 300 and a second communication unit 390 being associated with the external device 320. The frequency detector 391 is communicatively coupled to the controller 300 or the external device 320. The detection may be performed using a detection sequence for detecting the frequency. This detection sequence may, for example, be a detection sequence defined in the protocol to be used for communication between the controller 300 and the second communication unit 390. Potential protocols that may be used for communication between the controller 300 an and the external device 320 has been described earlier in this description. Thus, the method may comprise determining, using the frequency detector 391, the frequency for data communication, and initiating data communication between the controller 300 and the second communication unit 390. The data communication can, for example, comprise one or more control instructions for controlling the implantable pumping device 10 transmitted from the external device 320, or, for example, comprise data related to the operation of the implantable pumping device 10 and be transmitted from the controller 300.
In some examples, the medical implant may comprise or be connected to a power supply for powering the implantable pumping device 10. This will now be described with reference to
Alternatively, the implantable pumping device 10 may comprise a first implantable energy storage unit 40 for providing energy to an energy consuming part of the implantable pumping device 10, a second implantable energy storage unit 397 connected to the implantable energy storage unit 40 and connected to the energy consuming part, wherein the second implantable energy storage unit 397 is configured to be charged by the implantable energy storage unit 40 and to provide the energy consuming part with electrical power during startup of the energy consuming part. The second implantable energy storage unit 397 has a higher energy density than the first implantable energy storage unit 40. By having a “higher energy density” it may be meant that the second implantable energy storage unit 397 has a higher maximum energy output per time unit than the first implantable energy storage unit 40. The second energy storage 397 may be an energy provider as discussed below.
The energy consuming part may be any part of the implantable pumping device 10, such as a motor for powering the hydraulic pump, a valve, a processing or computing unit, a communication unit, a device for providing electrical stimulation to a tissue portion of the body of the patient, a CPU for encrypting information, a transmitting and/or receiving unit for communication with an external unit (not shown as part of the energy consuming part in the drawings, that is, the communication unit may be connected to the energy storage unit 40 and to the energy provider 397), a measurement unit or a sensor, a data collection unit, a solenoid, a piezo-electrical element, a memory metal unit, a vibrator, a part configured to operate a valve comprised in the medical implant, or a feedback unit.
In this way, an energy consuming part requiring a quick start or an energy consuming part which requires a high level or burst of energy for a start may be provided with sufficient energy. This may be beneficial as instead of having an idle component using energy, the component may be completely turned off and quickly turned on when needed. Further, this may allow the use of energy consuming parts needing a burst of energy for a startup while having a lower energy consumption when already in use. In this way, a battery or an energy storage unit having a slower discharging (or where a slower discharging is beneficial for the lifetime or health of the battery) may be used for the implant, as the extra energy needed for the startup is provided by the energy provider.
Energy losses may occur in a battery or energy storage unit of an implant if the battery or energy storage unit is discharged too fast. These energy losses may for example be in the form of heat, which may damage the battery or energy storage unit. By the apparatus described in these examples, energy may be provided from the battery or energy storage unit in a way that does not damage the battery or energy storage unit, which may improve the lifetime of the battery or energy storage unit and thereby the lifetime of the medical implant.
In some examples, the discharging from the implantable energy storage unit 40 during startup of the energy consuming part is slower than the energy needed for startup of the energy consuming part, i.e. the implantable energy storage unit 40 is configured to have a slower discharging than the energy needed for startup of the energy consuming part. That is, there is a difference between the energy needed by the energy consuming part and the energy the implantable energy storage unit 40 is capable of providing without damaging the implantable energy storage unit 40. In other words, a maximum energy consumption of the energy consuming part may be higher than the maximum energy capable of being delivered by the implantable energy storage unit 40 without causing damage to the implantable energy storage unit, and the energy provider 397 may be adapted to deliver an energy burst corresponding to difference between the required energy consumption and the maximum energy capable of being delivered by the implantable energy storage unit 40. The implantable energy storage unit 40 may be configured to store a substantially larger amount of energy than the energy burst provider 397, but may be slower to charge.
The implantable energy storage unit 40 may be any type of energy storage unit suitable for an implant, such as a re-chargeable battery or a solid state battery, such as a tionyl-chlorid battery. The implantable energy storage unit 40 may be connected to the energy consuming part and configured to power the energy consuming part after it has been started using the energy provider 397.
The energy provider 397 may be any type of part configured to provide a burst of energy for the energy consuming part. In some examples, the energy provider 397 is a capacitor, such as a start capacitor, a run capacitor, a dual run capacitor or a supercapacitor. The energy provider 397 may be connected to the implantable energy storage unit 40 and be adapted to be charged using the implantable energy storage unit 40. In some examples, the energy provider may be a second energy provider 397 configured to be charged by the implantable energy storage unit 40 and to provide the energy consuming part with electrical energy. The implantable pumping device 10 may further comprising a temperature sensor for sensing a temperature of the capacitor and the temperature sensor may be integrated or connected to the controller 300 such that the sensed temperature can be used as input for controlling the implantable pumping device 10 or as feedback to be sent to an external device 320.
A corresponding method for powering a medical implant may also be contemplated. The method comprises the steps of initiating an energy consuming part 302 of the implant, the energy consuming part being connected to an implantable energy storage unit 40, providing an initial burst of energy to the energy consuming part using an energy provider 397 connected to the implantable energy storage unit 40 and to the energy consuming part 302, the energy provider 397 being adapted to provide a burst of energy to the energy consuming part, and subsequently powering the energy consuming part 302 using the implantable energy storage unit 40.
In some examples, a maximum energy consumption of the energy consuming part is higher than the maximum energy capable of being delivered by the implantable energy storage unit 40 without causing damage to the implantable energy storage unit 40, and the energy provider 397 is adapted to deliver an energy burst corresponding to difference between the required energy consumption and the maximum energy capable of being delivered by the implantable energy storage unit 40.
The method may further comprise the step of charging the energy provider 397 using the implantable energy storage unit 40.
Initiating an energy consuming part 302 may comprise transitioning a control unit of the medical implant from a sleep mode to an operational or active mode.
The implantable energy storage unit 40 may be adapted to be wirelessly charged and the implantable energy storage unit may be connected to an internal charger 395 for receiving wireless energy from an external device 320 via an external charger 396, and the method may comprise wirelessly charging the implantable energy storage unit 40. In some examples, the method comprises controlling a receipt of electrical power from an external energy storage unit at the internal charger 395. The internal energy storage unit 40 may be charged via the receipt of a transmission of electrical power from an external energy storage unit 396 by the internal charger 395.
The embodiments described herein may advantageously be combined. For example, all the embodiments relating to the communication and controlling of the implant may be combined with the embodiments relating to the programming of the implant, the methods and systems for improving energy consumption or the power supply. The embodiments relating to the programming of the implant may be combined with any of the embodiments relating to improving the energy consumption or the power supply. The embodiments relating to the power supply maybe combined with the methods and systems for improving the energy consumption.
A computer program product of, or adapted to be run on, an internal computing unit or an external device is also provided, which comprises a computer-readable storage medium with instructions adapted to make the internal computing unit and/or the external device perform the actions as described in any embodiment or example above.
Starting from the lowest level of authority, the patient remote control external device 320″ comprises a wireless transceiver 328 for communicating with the implanted medical device 100. The remote control 320″ is capable of controlling the operation of the implanted medical device 100 via the controller 300, by controlling pre-set functions of the implantable medical device 100, e.g. for operating an active portion of the implanted medical device 100 for performing the intended function of the implanted medical device 100. The remote control 320″ is able communicate with implanted medical device 100 using any standard or proprietary protocol designed for the purpose. In the embodiment shown in
UWB communication is performed by the generation of radio energy at specific time intervals and occupying a large bandwidth, thus enabling pulse-position or time modulation. The information can also be modulated on UWB signals (pulses) by encoding the polarity of the pulse, its amplitude and/or by using orthogonal pulses. A UWB radio system can be used to determine the “time of flight” of the transmission at various frequencies. This helps overcome multipath propagation, since some of the frequencies have a line-of-sight trajectory, while other indirect paths have longer delay. With a cooperative symmetric two-way metering technique, distances can be measured to high resolution and accuracy. UWB is useful for real-time location systems, and its precision capabilities and low power make it well-suited for radio-frequency-sensitive environments, such as health care environments.
In embodiments in which a combination of BT and UWB technology is used, the UWB technology may be used for location-based authentication of the remote control 320″, whereas the communication and/or data transfer could take place using BT or any other way of communicating different from the UWB. The UWB signal could in some embodiments also be used as a wake-up signal for the controller 300, or for the BT transceiver, such that the BT transceiver in the implanted medical device 100 can be turned off when not in use, which eliminates the risk that the BT is intercepted, or that the controller 300 of the implanted medical device 100 is hacked by means of BT communication. In embodiments in which a BT (or alternatives)/UWB combination is used, the UWB connection may be used also for the transmission of data. In the alternative, the UWB connection could be used for the transmission of some portions of the data, such as sensitive portions of the data, or for the transmission of keys for the unlocking of encrypted communication sent over BT.
The remote control 320″ comprises computing unit 326 which runs a software application for communicating with the implanted medical device 100. The computing unit 326 can receive input directly from control buttons 335 arranged on the remote control 320″ or may receive input from a control interface 334i displayed on a patient display device 334 operated by the patient. In the embodiments in which the remote control 320″ receives input from a control interface 334i displayed on the patient display device 334 operated by the patient, the remote control 320″ transmits the control interface 334i in the form of a web-view portal, i.e. a remote interface that run in a sandbox environment on the patient's display device 334. A sandbox environment means that it runs on the display device 334 but only displays what is presented from the remote control and can only use a tightly controlled set of commands and resources, such as storage and memory space as well as network access, the ability to inspect the host system and read or write from other input devices connected to the display device 334 is extremely limited. Any action or command generated by the patient display device is like controlling a webpage. All acting software is located on the remote control that only displays its control interface onto the patient display unit. The computing unit 326 is further configured to encrypt the control interface before transmission to the patient display device 334, and encrypt the control commands before transmission to the implanted medical device 100. The computing unit 326 is further configured to transform the received user input into control commands for wireless transmission to the implantable medical device 100.
The patient's display device 334 could for example be a mobile phone, a tablet or a smart watch. In the embodiment shown in
The remote control is normally not connected to the DDI or the Internet to increase security. In addition, the remote control 320″ may in one embodiment have its own private key and in a specific embodiment the remote control 320″ is activated by the patient's private key for a certain time period. This may activate the function of the patient's display device and the remote wed-view display portal supplied by the remote control to the patient's display device.
The patient's private key is supplied in a patient private key device compromising a smartcard that may be inserted or provided close to the remote control 320″ to activate a permission to communicate with the implant 100 for a certain time period.
The patient's display device 334 may (in the case of the display device 334 being a mobile phone or tablet) comprise auxiliary radio transmitters for providing auxiliary radio connection, such as Wi-Fi or mobile connectivity (e.g. according to the 3G, 4G or 5G standards). The auxiliary radio connection(s) may have to be disconnected to enable communication with the remote control 320″. Disconnecting the auxiliary radio connections reduces the risk that the integrity of the control interface 334i displayed on the patient's display device 334 is compromised, or that the control interface 334i displayed on the patient's display device 334 is remote controlled by an unauthorized device.
In alternative embodiments, control commands are generated and encrypted by the patient's display device and transmitted to the DDI 330. The DDI 330 could either alter the created control commands to commands readable by the remote control 320″ before further encrypting the control commands for transmission to the remote control 320″ or could simply add an extra layer of encryption before transmitting the control commands to the remote control 320″, or could simply act as a router for relaying the control commands from the patients' display device 334 to the remote control 320″. It is also conceivable that the DDI 330 adds a layer of end-to-end encryption directed at the implanted medical device 100, such that only the implanted medical device 100 can decrypt the control commands to perform the commands intended by the patient. In the embodiments above, when the patient remote display device 334 is communicating with the DDI, the patient's display device 334 may be configured to only display and interact with a web-view portal provided by a section of the DDI and it is conceivable that the web-view portal is a view of a back-end provided on the DDI 330, and in such embodiments, the patient interacting with the control interface on the patient's display device 334 is equivalent to the patient interacting with an area of the DDI 330.
The patient's display device 334 could have a first and second application related to the implanted medical device 100. The first application is the control application displaying the control interface 334i for control of the implanted medical device 100, whereas the second application is a general application for providing the patient with general information of the status of the implanted medical device 100 or information from the DDI 330 or HCP, or for providing an interface for the patient to provide general input to the DDI 330 or HCP related to the general wellbeing of the patient, the lifestyle of the patient or related to general input from the patient concerning the function of the implanted medical device 100. The second application, which do not provide input to the remote control 320″ and/or the implanted medical device 100 thus handles data which is less sensitive. As such, the general application could be configured to function also when all auxiliary radio connections are activated, whereas switching to the control application which handles the more sensitive control commands and communication with the implanted medical device 100 could require that the auxiliary radio connections are temporarily de-activated. It is also conceivable that the control application is a sub-application running within the general application, in which case the activation of the control application as a sub-application in the general application could require the temporary de-activation of auxiliary radio connections. In the embodiment shown in
In general, a hardware key is needed to activate the patient display device 334 for certain time period to control the web-view portal of the remote control 320″, displaying the control interface 334i for control of the implanted medical device 100.
In the embodiments in which the patients display device 334 is configured to only display and interact with a web-view provided by another unit in the system, it is conceivable that the web-view portal is a view of a back-end provided on the DDI 330, and in such embodiments, the patient interacting with the control interface on the patient's display device is equivalent to the patient interacting with an area of the DDI 330.
Moving now to the P-EID 320″′. The P-EID 320″′ is an external device used by the patient, patient external device, which communicates with, and charges, the implanted medical device 100. The P-EID 320″′ can be remotely controlled by the HCP to read information from the implanted medical device 100. The P-EID 320″′ controls the operation of the implanted medical device 100, control the charging of the medical device 100, and adjusts the settings on the controller 300 of the implanted medical device 100 by changing pre-defined pre-programed steps and/or by the selection of pre-defined parameters within a defined range., e.g. Just as the remote control 320″, the P-EID 320″′ could be configured to communicate with the implanted medical device 100 using BT or UWB communication or any other proprietary or standard communication method. Since the device may be used for charging the implant, the charging signal and communication could be combined. Just as with the remote control 320″, it is also conceivable to use a combination of UWB wireless communication and BT for enabling positioning of the P-EID 320″ as a way to establish that the P-EID 320″ is at a position which the implanted medical device 100 and/or patient and/or HCP can acknowledge as being correct, e.g. in the direct proximity to the correct patient and/or the correct medical device 100. Just as for the remote control 320″, in embodiments in which a combination of BT and UWB technology is used, the UWB technology may be used for location-based authentication of the P-EID 320″, whereas the communication and/or data transfer could take place using BT. The P-EID 320″ comprises a wireless transmitter/transceiver 328 for communication and also comprises a wireless transmitter 325 configured for transferring energy wirelessly, which may be in the form of a magnetic field or any other signal such as electromagnetic, radio, light, sound or any other type of signal to transfer energy wirelessly to a wireless receiver 395 of the implanted medical device 100. The wireless receiver 395 of the implanted medical device 100 is configured to receive the energy in the form of the magnetic field and transform the energy into electric energy for storage in an implanted energy storage unit 40, and/or for consumption in an energy consuming part of the implanted medical device 100 (such as the operation device, controller 300 etc.). The magnetic field generated in the P-EID 320″′ and received in the implanted medical device 100 is denoted charging signal. In addition to enabling the wireless transfer of energy from the P-EID 320″′ to the implanted medical implant 10, the charging signal may also function as a means of communication. E.g., variations in the frequency of the transmission, and/or the amplitude of the signal may be uses as signaling means for enabling communication in one direction, from the P-EID 320″′ to the implanted medical device 100, or in both directions between the P-EID 320″′ and the implanted medical device 100. The charging signal in the embodiment shown in
Just as for the remote control 320″, the UWB signal could in some embodiments also be used as a wake-up signal for the controller 300, or for the BT transceiver, such that the BT transceiver in the implanted medical device 100 can be turned off when not in use, which eliminates the risk that the BT is intercepted, or that the controller 300 of the implanted medical device 100 is hacked by means of BT communication. In the alternative, the charging signal could be used as a wakeup signal for the BT, as the charging signal does not travel very far. Also, as a means of location-based authentication, the effect of the charging signal or the RSSI could be assessed by the controller 300 in the implanted medical device 100 to establish that the transmitter is within a defined range. In the BT/UWB combination, the UWB may be used also for transmission of data. In some embodiments, the UWB and/or the charging signal could be used for the transmission of some portions of the data, such as sensitive portions of the data, or for the transmission keys for unlocking encrypted communication sent by BT. Wake-up could be performed with any other signal.
UWB could also be used for waking up the charging signal transmission, to start the wireless transfer of energy or for initiating communication using the charging signal. As the signal for transferring energy has a very high effect in relation to normal radio communication signals, the signal for transferring energy cannot be active all the time, as this signal may be hazardous e.g., by generating heat.
The P-EID 320″′ communicates with the HCP over the Internet by means of a secure communication, such as over a VPN. The communication between the HCP and the P-EID 320″′ is preferably encrypted. Preferably, the communication is sent via the DDI, which may only be relying the information. The communication from the HCP to the implanted medical device 100 may be performed using an end-to-end encryption, in which case the communication cannot be decrypted by the P-EID 320″′. In such embodiments, the P-EID 320″′ acts as a router, only passing on encrypted communication from the HCP to the controller 300 of the implanted medical device 100 (without full decryption). This solution further increases security as the keys for decrypting the information rests only with the HCP and with the implanted medical device 100, which reduces the risk that an unencrypted signal is intercepted by an unauthorized device. The P-EID 320″′ may add own encryption or information, specifically for security reasons. The P-EID 320″′ may hold its own private key and may be allowed to communicate with the implant 100 based on confirmation from the patient's private key, which may be provided as a smartcard to be inserted in a slot of the P-EID 320″′ or hold in close proximity thereto to be read by the P-EID 320″′. These two keys will add a high level of security to the performed communication between the Implant 100 and the P-EID 320″′ since the patient's hardware key in this example on the smartcard may activate and thereby allow the communication and action taken in relation to the implant. The P-EID 320″′ may as previously described change the treatment setting of the implant by selecting pre-programmed steps of the treatment possibilities. Such pre-programmed treatment options may include for example to change: at least one of the position, frequency and level of compression of an implanted heart compression device, the flow of an apparatus assisting the pump function of a heart of the patient, the flow of an apparatus assisting the pump function comprising a turbine bump placed within a patient's blood vessel for assisting the pump function of the heart, the function of an operable artificial heart valve, at least one of the function of, the valve opening pressure and time for closure of an operable artificial heart valve for increasing the blood flow to the coronary arteries. at least one of the functions of, the amount and/or concentration of a drug from an implantable drug delivery device, at least one of the injection site and frequency as well as amount of drug delivered by an implantable drug delivery device for injecting directly into a blood vessel and change the position of the injection site, all from within the patient's body, at least one of the injection site and frequency as well as amount of drug delivered by an implantable drug delivery device for injecting potency enhancing drugs into an erectile tissue of the patient, at least one of the level of constriction, pressure or position of a hydraulic, mechanic, and/or electric constriction implant, the volume of an operable volume filling device, the constriction of an operable gastric band, at least one of the level and time of stretching and when such stretching occur in relation to food intake of a patient for an operable implant for stretching the stomach wall of the patient for creating satiety, when an action should be taken relating to an implant configured to sense the amount of food intake based on number of times a patient swallows solid food, at least one of the size and shape of an operable cosmetic implant, at least one of the shape and size in the breast region of a patient of an operable cosmetic implant for adjustment, at least one of pressure, volume, sensor input or time of an implant controlling medical device for the emptying of a urinary bladder, at least one of the closing pressure, the time to close after urinating, how much extra pressure would be allowed at exercise of an implant hindering urinary leakage, at least one of the closing pressure, the time to close after revealing, how much extra pressure would be allowed at exercise of an implant hindering anal incontinence, parameters of an implant controlling the emptying of fecal matter, such as pressure, volume, pump or motor position etc., parameters of an implant monitoring an aneurysm, such as pressure, aneurysm expansion, volume, reservoir volume, etc., parameters of an implant for hindering the expansion of an aneurysm, such as pressure, aneurysm expansion, volume, reservoir volume, etc., parameters of an implant lubricating a joint, such as volume, reservoir volume, etc., parameters of an implant for affecting the blood flow to an erectile tissue of the patient, such as the level of constriction, pressure or position of a hydraulic, mechanic, and/or electric constriction implant, parameters of an implant for simulating the engorgement of an erectile tissue, such as the level of stimulation, frequency, or amplitude of an electrical stimulation, parameters of an implant with a reservoir for holding bodily fluids, such as volume, reservoir volume, etc., parameters of an implant storing and/or emptying a bodily reservoir or a surgically created reservoir, such as stimulation parameters in a peristaltic wave, stretch or bending sensors, reservoir volume, etc., parameters of an implant communicating with a database outside the body, such as key handshake, new key pairing, signal amplitude etc., parameters of an implant able to be programmed from outside the body, parameters of an implant able to be programmed from outside the body with a wireless signal, parameters of an implant treating impotence, such as pressure, amount of drug delivered, time for erection period etc., parameters of an implant controlling the flow of eggs in the uterine tube, such as the level of constriction, time period, position of a hydraulic, mechanic, and/or electric constriction implant, parameters of an implant controlling the flow of sperms in the uterine tube, such as the level of stimulation, frequency, or amplitude of an electrical stimulation, parameters of an implant controlling the flow of sperms in the vas deferens, such as the level of constriction, time period, position of a hydraulic, mechanic, and/or electric constriction implant, parameters of an implant for hindering the transportation of the sperm in the vas deferens, such as the level of constriction, time period, position of a hydraulic, mechanic, and/or electric constriction implant, parameters of an implant treating osteoarthritis, parameters of an implant performing a test of parameters inside the body, parameters of an implant controlling specific treatment parameters from inside the body, parameters of an implant controlling bodily parameters from inside the body, parameters of an implant controlling the blood pressure, parameters of an implant controlling the blood pressure by affecting the dilatation of the renal artery, such as heat and time period in relation to blood pressure, parameters of an implant controlling a drug treatment parameter, parameters of an implant controlling a parameter in the blood, parameters of an implant for adjusting or replacing any bone part of a body of the patient, parameters of an implant replacing an organ of the patient or part of an organ of the patient or the function thereof, parameters of a vascular treatment device, such as bending, expanding sensor, parameters of an implant adapted to move fluid inside the body of the patient, such as volume, pumping parameters, parameters of an implant configured to sense a parameter related to the patient swallowing, parameters of an implant configured to exercise a muscle with electrical or mechanical stimulation, such as stimulation parameters, amplitude frequency time period etc., parameters of an implant configured for emptying an intestine portion on command, such as electrical stimulation parameters, peristaltic wave adjustment etc., parameters of an operable implant configured to be invaginated in the stomach of the patient to reduce the volume of the stomach substantially more than the volume of the device, such as volume, parameters of an implant configured for emptying the urinary bladder from within the patient's body by compressing the bladder, such as pressure, volume and time parameters of an implant configured for draining fluid from within the patient's body, parameters of an implant configured for the active lubrication of a joint with an added lubrication fluid, such as frequency and/or volume of the drug supplied, parameters of an implant configured for removing clots and particles from the patient's blood stream, parameters of an implant configured for elongating or straightening a bone in the patient, to reduce scoliosis, force, length etc., parameters of a device to stimulate the brain for a several position to a focused point, parameters of an artificial stomach replacing the function of the natural stomach, parameters of an implant configured for adjusting the position of a female's urinary tract or bladder neck, parameters of an implant configured for stimulating the ampulla vas deference and creating temporary constriction.
When the implanted medical device 100 is to be controlled and/or updated remotely by the HCP, via the P-EID 320″′, a HCP Dedicated Device (DD) 332 displays an interface in which predefined program steps or setting values are presented to the HCP. The HCP provides input to the HCP DD 332 by selecting program steps, altering settings and/or values or by altering the order in which pre-defined program steps is to be executed. The instructions/parameters inputted into the HCP DD 332 for remote operation is in the embodiment shown in
The Health Care Provider EID (HCP EID) 320′ have the same features as the P-EID 320″ and can communicate with the implanted medical device 100 in the same alternative ways (and combinations of alternative ways) as the P-EID 320″′. However, in addition, the HCP EID 320′ also enables the HCP to freely reprogram the controller 300 of the implanted medical device 100, including replacing the entire program code running in the controller 300. The idea is that the HCP EID 320′ always remain with the HCP and as such, all updates to the program code or retrieval of data from the implanted medical device 100 using the HCP EID 320′ is performed with the HCP and patient present (i.e. not remote). The physical presence of the HCP is an additional layer of security for these updates which may be critical to the function of the implanted medical device 100.
In the embodiment shown in
In the embodiment shown in
The HCP EID external device may comprise at least one of;
The HCP external device 320′ may further comprise at least one wireless transceiver 328 configured for communication with a data infrastructure server, DDI, through a first network protocol.
A dedicated data infrastructure server, DDI, is in one embodiment adapted to receive commands from said HCP external device 320′ and may be adapted to rely the received commands without opening said commands directed to the patient external device 320″, the DDI 330 comprising one wireless transceiver configured for communication with said patient external device 320″.
The patient EID external device 320″ is in one embodiment adapted to receive the commands relayed by the DDI, and further adapted to send these commands to the implanted medical device 100, which is adapted to receive commands from the HCP, Health Care Provider, via the DDI 330 to change the pre-programmed treatment steps of the implanted medical device 100. The patient EID is adapted to be activated and authenticated and allowed to perform the commands by the patient providing a patient private key device 333′. The patient's private key device is in one embodiment adapted to be provided to the patient external device by the patient via at least one of; a reading slot or comparable for the patient private key device 333′, an RFID communication or other close distance wireless activation communication.
The patient EID external device, in one or more embodiments, comprises at least one of;
The patient EID external device may in one or more embodiments comprise at least one wireless transceiver configured for communication with the implanted medical device through a second network protocol.
The patient's key 333′ is in the embodiment shown in
The HCP's key 333″, in the embodiment shown in
In alternative embodiments, it is however conceivable that the hardware key solution is replaced by a two-factor authentication solution, such as a digital key in combination with a PIN code or a biometric input (such as face recognition and/or fingerprint recognition). The key could also be a software key, holding similar advance key features, such as the Swedish Bank ID being a good example thereof.
In the embodiment shown in
The DDI 330 is logging information of the contact between the HCP and the remote control 320″ via implant feedback data supplied from the implant to P-EID 320″′. Data generated between the HCP and the patient's display device 334, as well as between the HCP and auxiliary devices 336 (such as tools for following up the patient's treatments e.g. a scale in obesity treatment example or a blood pressure monitor in a blood pressure treatment example) are logged by the DDI 330. In some embodiments, although less likely, the HCP DDD 332 may also handle the communication between the patient's display device 334 and the remote control 320″. In
In all examples, the communication from the HCP to: the P-EID 320″′, the remote control 320″, the patient's display device 334 and the auxiliary devices 336 may be performed using an end-to-end encryption. In embodiments with end-to-end encryption, the communication cannot be decrypted by the DDI 330. In such embodiments, the DDI 330 acts as a router, only passing on encrypted communication from the HCP to various devices. This solution further increases security as the keys for decrypting the information rests only with the HCP and with the device sending or receiving the communication, which reduces the risk that an unencrypted signal is intercepted by an unauthorized device. The P-EID 320″′ may also only pass on encrypted information.
In addition to acting as an intermediary or router for communication, the DDI 330 collects data on the implanted medical device 100, on the treatment and on the patient. The data may be collected in an encrypted form, in an anonymized form or in an open form. The form of the collected data may depend on the sensitivity of the data or on the source from which the data is collected. In the embodiment shown in
In the specific embodiment disclosed in
The wireless connections specifically described in the embodiment shown in
A system configured for changing pre-programmed treatment settings of an implantable medical device, when implanted in a patient, from a distant remote location in relation to the patient, the system comprising:
Although wireless transfer is primarily described in the embodiment disclosed with reference to
The scenario described with reference to
The scenario described with reference to
The scenario described with reference to
The scenario described with reference to
The scenario described with reference to
One probable scenario/design of the communication system is for the purpose of changing pre-programmed treatment settings of an implantable medical device, when implanted in a patient, from a distant remote location in relation to the patient. The system comprises at least one health care provider, HCP, external device 320′ adapted to receive a command from the HCP to change said pre-programmed treatment settings of an implanted medical device, further adapted to be activated and authenticated and allowed to perform said command by the HCP providing a HCP private key device 333″ adapted to be provided to an HCP EID external device via at least one of: a reading slot or comparable for the HCP private key device, a RFID communication or other close distance wireless activation communication. The HCP EID external device comprising at least one of: a reading slot or comparable for the HCP private key device, a RFID communication, and other close distance wireless activation communication or electrical direct contact. The HCP EID external device further comprises at least one wireless transceiver configured for communication with a patient EID external device, through a first network protocol, wherein the system comprises the patient EID external device, the patient EID external device being adapted to receive command from said HCP external device, and to relay the received command without modifying said command to the implanted medical device. The patient EID external device comprising one wireless transceiver configured for communication with said patient external device. The patient EID is adapted to send the command to the implanted medical device, to receive a command from the HCP to change said pre-programmed treatment settings of the implanted medical device, and further to be activated and authenticated and allowed to perform said command by the patient providing a patient private key device comprising a patient private key.
Although the different scenarios outlined in
The
The control device 300 controls the pair of short constriction elements 101a′, 101a″, the pair of elongate constriction elements 101b′, 101b″ and the pair of short elements 101c′, 101c″ to constrict and release the selected portion independently of one another.
Although
Thus, when any one of the constriction elements 101a-101c constricts a portion of urinary bladder U, its associated electrodes E1,E2,E3 electrically stimulate the constricted portion with electric pulses so that the wall of the urinary bladder of the constricted portion thickens and closes the passageway of urinary bladder U.
The rotary peristaltic pump 10 may also comprise a cancellation unit configured to be placed downstream the rotor and the constriction elements. The cancellation unit may be configured to cancel the electrical stimulation such that the urinary sphincter remains substantially unaffected by the electrical stimulation.
The method further comprises the step M2 of dissecting a portion of the luminary organ for preparing the portion of the urinary bladder for the placement and fixation of an implantable pumping devise.
The method further comprises the step M3 of inserting an implantable pumping device into the body of the patient. The method may be commenced as a minimally invasive procedure (such as Laparoscopic, SILS, NOTES etc.) and continued as open surgery when the implantable pumping device should be inserted. The procedure could also be performed as a hand assisted minimally invasive procedure in which the surgeon can insert a hand through a small incision in the abdomen. Hand assisted surgery has the benefit of providing sensory perception and the possibility to guide the surgical instruments whilst maintaining the possibility of visually observing the entire procedure on a TV screen overhead.
The step M3 of inserting an implantable pumping device into the body of the patient could comprise inserting the implantable pumping device 10 described with reference to
The step M3 of inserting an implantable pumping device into the body of the patient could comprise inserting the implantable pumping device 10 described with reference to
The step M3 of inserting an implantable pumping device into the body of the patient could comprise inserting the implantable pumping device 10 described with reference to
The step M3 of inserting an implantable pumping device into the body of the patient could comprise inserting the implantable pumping device 10 described with reference to
The step M3 of inserting an implantable pumping device into the body of the patient could comprise inserting the implantable pumping device 10 described with reference to
The step M3 of inserting an implantable pumping device into the body of the patient could comprise inserting the implantable pumping device 10 described with reference to
The step M3 of inserting an implantable pumping device into the body of the patient could comprise inserting the implantable pumping device 10 described with reference to
The step M3 of inserting an implantable pumping device into the body of the patient could comprise inserting the implantable pumping device 10 described with reference to
The step M3 of inserting an implantable pumping device into the body of the patient could comprise inserting the implantable pumping device 10 described with reference to
The step M3 of inserting an implantable pumping device into the body of the patient could comprise inserting the implantable pumping device 10 described with reference to
The step M3 of inserting an implantable pumping device into the body of the patient could comprise inserting the implantable pumping device 10 described with reference to
The step M3 of inserting an implantable pumping device into the body of the patient could comprise inserting the implantable pumping device 10 described with reference to
The step M3 of inserting an implantable pumping device into the body of the patient could comprise inserting the implantable pumping device 10 described with reference to
The step M3 of inserting an implantable pumping device into the body of the patient could comprise inserting the implantable pumping device 10 described with reference to
The step M3 of inserting an implantable pumping device into the body of the patient could comprise inserting an implantable pumping device 10 comprising one or more constriction devices as described with reference to
The step M3 of inserting an implantable pumping device into the body of the patient could comprise inserting an implantable pumping device 10 comprising one or more constriction devices as described with reference to
The step M3 of inserting an implantable pumping device into the body of the patient could comprise inserting the implantable pumping device 10 described with reference to
The step M3 of inserting an implantable pumping device into the body of the patient could comprise inserting the implantable pumping device 10 described with reference to
The step M3 of inserting an implantable pumping device into the body of the patient could comprise inserting the implantable pumping device 10 described with reference to
The step M3 of inserting an implantable pumping device into the body of the patient could comprise inserting the implantable pumping device 10 described with reference to
The step M3 of inserting an implantable pumping device into the body of the patient could comprise inserting an implantable pumping device 10 comprising one or more constriction devices as described with reference to
The step M3 of inserting an implantable pumping device into the body of the patient could comprise inserting the implantable pumping device 10 described with reference to
The step M3 of inserting an implantable pumping device into the body of the patient could comprise inserting an implantable pumping device 10 comprising one or more constriction devices as described with reference to
The step M3 of inserting an implantable pumping device into the body of the patient could comprise inserting an implantable pumping device 10 comprising one or more constriction devices as described with reference to
The step M3 of inserting an implantable pumping device into the body of the patient could comprise inserting an implantable pumping device 10 comprising one or more constriction devices as described with reference to
The step M3 of inserting an implantable pumping device into the body of the patient could comprise inserting the implantable pumping device 10 described with reference to
The step M3 of inserting an implantable pumping device into the body of the patient could comprise inserting the implantable pumping device 10 described with reference to
The step M3 of inserting an implantable pumping device into the body of the patient could comprise inserting the implantable pumping device 10 described with reference to
The step M3 of inserting an implantable pumping device into the body of the patient could comprise inserting the implantable pumping device 10 described with reference to
The method of implanting the implantable pumping device described in the flow chart of
The step M4 of placing the implantable pumping device in connection with the urinary bladder could optionally comprise the step M6 of securing the implantable constriction device by means of at least one of sutures, staples and tissue growth promoting structure. A tissue growth promoting structure could for example comprise a mesh configured to be integrated with fibrotic tissue or a structure made from a microporous material.
The step M3 of inserting an implantable pumping device into the body of the patient may comprise the step of inserting an implantable controller into the body of the patient, for controlling the implantable constriction device. The step of inserting an implantable controller may comprise fixating the implantable controller to tissue or bone in the body of the patient. The implantable controller could be the controller described with reference to any of the figures within this application.
The step M3 of inserting an implantable pumping device into the body of the patient could comprise inserting an operation device comprising at least one of: an implantable hydraulic pump and an implantable valve and fixating the implantable operation device to tissue or bone in the body of the patient. The hydraulic pump could be the hydraulic pump of
The method could further comprise the step M7 of implanting at least one injection port, which is in fluid connection with the operation device. The step M7 of implanting at least one injection port could comprise fixating the at least one injection port, which may be done subcutaneously, for example by means of at least one of sutures, staples and tissue growth promoting structure. The injection port comprises a self-sealing membrane which may be penetrated by an injection needle for injecting a fluid into the implantable injection port.
The method may further comprise the step M8 of calibrating the fluid level in the implantable pumping device through injection or retraction of fluid via the implantable injection port. Calibration of fluid levels can be done at routine check-up or in response to the implantable pumping device not functioning optimally or in response to the implantable pumping device transmitting a signal indicating that the fluid level needs to be calibrated. The need for calibration can be based on leakage or diffusion of fluid from the implantable pumping device.
The method may further comprise the step M9 of calibrating the pressure exerted by the implantable pumping device on the luminary organ, which may comprise calibrating the pressure in the implantable pumping device through the measurement of the pressure in the implantable pumping device, e.g. by means of a pressure sensor in direct or indirect contact with the fluid in the implantable pumping device. The calibration of the pressure exerted by the implantable pumping device on the luminary organ my alternatively be performed by means of a pressure sensitive catheter M14 inserted into the luminary organ and measuring the force exerted thereon by the implantable constriction device. The pressure may be exerted by the constriction devices or operable constriction elements of the implantable pumping device as described herein. Therefore, the pressure may be calibrated for the constriction device or operable constriction elements individually to ensure that each constriction device or operable constriction element is exerting a high enough pressure.
The method may further comprise the step M10 of calibrating the time during which the implantable pumping device and its constriction devices is to remain closed after activation. The implantable pumping device will constrict the urinary bladder when activated in order to evacuate urine from the bladder. Depending on the patient different times that the constriction devices of the implantable pumping device are closed may be needed in order to ensure that the urine has been evacuated properly prior to opening the implantable pumping device again.
The method may further comprise the step M11 of calibrating the speed with which the implantable pumping device should constrict the luminary organ. This could allow the patient to provide feedback to the device with regards to the closing such that the implantable constriction device functions in an optimal way. In case the implantable pumping device closes to quickly, the patient may not be able to control the flow of urine. In the same way, a to slow closing may be problematic for the patient when trying to urinate.
The method may further comprise the step M12 of calibrating the pressure exerted on the urinary bladder relative to the blood pressure if the patient. This could be used to make sure that the tissue of the urinary bladder is not constricted such that the blood flow in the tissue is adversely affected or hampered. The pressure exerted on the urinary bladder could be calibrated relative to the systolic blood pressure of the patient, such that the pressure does not exceed the systolic blood pressure, to allow blood to be pressed into the tissue during the systolic cardiac phase. In the alternative, the pressure exerted on the urinary bladder could be calibrated relative to the diastolic blood pressure of the patient, such that the pressure does not exceed the diastolic blood pressure, to allow normal circulation through the tissue of the urinary bladder.
The method may further comprise the step M14 of calibrating the electrical stimulation of the tissue of the urinary bladder on the basis of a physiological marker, such as an ischemia marker, or on the basis of input from the patient e.g. related to a sensory response induced by the electrical stimulation, such as pain related to the electrical stimulation.
The method may further comprise the steps M15-M19 of performing tests related to the function of the implantable constriction device. These tests may be performed during the surgical procedure or in closely after the surgical procedure.
The method may comprise the step M15 of testing a fully open catheter mode, in which a hydraulic constriction element is emptied as much as possible to allow the urinary bladder to expand maximally such that a catheter can be inserted through the implantable constriction device.
The method may comprise the step M16 of testing a feedback function by providing sensory feedback to the patient, which could be sensory feedback in the form of vibrations created by the motor of the implantable pumping device, or created by a separate vibrator. Sensory feedback could in the alternative be created in the form of electrical stimulation.
The method may comprise the step M17 of testing a post-operative mode for enabling healing of the luminary organ and the surrounding tissue after implantation. It may be the case that the tissue surrounding the device needs to heal before the device may be used to restrict the flow of fluid in the urinary bladder. It may also be the case that the device needs to be fixated by the ingrowth of fibrotic tissue into a fixating structure for the fixation of the implantable constriction device, which may be tested in a test of a post-operative mode for enabling growth of fibrotic tissue M18.
The method may comprise the step M19 of testing an electrical stimulation of the tissue of the urinary bladder to establish that the electrical stimulation and the control and calibration of the electrical stimulation functions as intended.
A system for mitigating fibrin creation caused by the contact between the medical implant and the tissue or flowing blood of a patient, will now be described with reference to
All foreign matter implanted into the human body inevitably causes an inflammatory response. In short, the process starts with the implanted medical device immediately and spontaneously acquiring a layer of host proteins. The blood protein-modified surface enables cells to attach to the surface enabling monocytes and macrophages to interact on the surface of the medical implant. The macrophages secrete proteins that modulate fibrosis and in turn developing the fibrosis capsule around the foreign body. In practice, a fibrosis capsule is a dense layer of excess fibrous connective tissue. On a medical device implanted in the abdomen, the fibrotic capsule typically grows to a thickness of about 0.5 mm-2 mm, and is substantially inelastic and dense.
The body tends to react to a medical implant, partly because the implant is a foreign object, and partly because the implant interacts mechanically with tissue of the body and/or blood flowing within the body. Implantation of medical devices and or biomaterial in the tissue of a patient may trigger the body's foreign body reaction (FBR). FBR leads to a formation of foreign body giant cells and the development of a fibrous capsule enveloping the implant. The formation of a dense fibrous capsule that isolates the implant from the host is the common underlying cause of implant failure. Implantation of medical devices and or biomaterial in a blood flow may also cause the formation of fibrous capsules due to the attraction of certain cells within the blood stream.
Implants may, due to the fibrin formation cause blood clotting leading to complications for the patient. Implants in contact with flowing blood and/or placed in the body may also lead to bacterial infection.
One common way of counteracting the creation of blood clots is by using blood thinners of different sorts. One commonly used blood thinner is called heparin. However, heparin have certain side-effects that are undesirable.
Fibrin is an insoluble protein that is partly produced in response to bleeding and is the major component of blood clots. Fibrin is formed by fibrinogen, a soluble protein that is produced by the liver and found in blood plasma. When tissue damage results in bleeding, fibrinogen is converted at the wound into fibrin by the action of thrombin, a clotting enzyme. The fibrin then forms, together with platelets, a hemostatic plug or clot over a wound site.
The process of forming fibrin from fibrinogen starts with the attraction of platelets. Platelets have thrombin receptors on their surfaces that bind serum thrombin molecules. These molecules can in turn convert soluble fibrinogen into fibrin. The fibrin then forms long strands of tough and insoluble protein bound to the platelets. The strands of fibrin are then cross-linked so that it hardens and contracts, this is enabled by Factor XIII which is a zymogen found in the blood of humans.
Fibrin may also be created due to the foreign body reaction. When a foreign body is detected in the body the immune system will become attracted to the foreign material and attempt to degrade it. If this degradation fails, an envelope of fibroblasts may be created to form a physical barrier to isolate the body from the foreign body. This may further evolve into a fibrin sheath, in case the foreign body is an implant this may hinder the function of the implant.
Implants can, when implanted in the body, be in contact with flowing blood. This may cause platelet adhesion on the surface of the implants. The platelets may then cause the fibrinogen in the blood to convert into fibrin creating a sheath on and or around the implant. This may prevent the implant from working properly and may also create blood clots that are perilous for the patient.
Implants not in contact with flowing blood can still malfunction due to fibrin creation. Here the foreign body reaction may be the underlying factor for the malfunction. Further, the implantation of a foreign body into the human body may cause an inflammatory response. The response generally persists until the foreign body has been encapsulated in a relatively dense layer of fibrotic connective tissue, which protects the human body from the foreign body. The process may start with the implant immediately and spontaneously acquiring a layer of host proteins. The blood protein-modified surface enables cells to attach to the surface, enabling monocytes and macrophages to interact on the surface of the implant. The macrophages secrete proteins that modulate fibrosis and in turn develop the fibrosis capsule around the foreign body, i.e., the implant. In practice, a fibrosis capsule may be formed of a dense layer of excess fibrous connective tissue. The inelastic properties of the fibrotic capsule may lead to hardening, tightness, deformity, and distortion of the implant, which in severe cases may result in revision surgery.
A fibrin sheath 740 may be created on any implantable medical device 10 and may then cover certain necessary part of the device 10 inhibiting the function of the device 10.
Implants or biomaterials that are inserted to support or replace body parts may also cause infections of different sorts. Bacterial colonization that lead to implant-associated infections are a known issue for many types of implants. For example, the commensal skin bacteria, Staphylococci, and the Staphylococcus aureus tend to colonize foreign bodies such as implants and may cause infections. A problem with the Staphylococci is that it may also produce a biofilm around the implant encapsulating the bacterial niche from the outside environment. This makes it harder for the host defense systems to take care of the bacteria. There are other examples of bacteria and processes that creates bacteria causing infection due to implants.
The implantable medical device 10 may for example be an implantable pumping device 10 configured to evacuate urine from a urinary bladder as described in relation to any one of
In different embodiments described in this application different parts of such an implantable pumping device 10 may be in contact with a urinary bladder U. Any part engaging the urinary bladder U may be coated with a coating 760. For example, the constriction devices, constriction elements, cushioning elements and more parts in contact with the urinary bladder U may be coated with coating 760.
The coating 760 may comprise at least one layer of a biomaterial. The coating 760 may comprise a material that is antithrombotic. The coating 760 may also comprise a material that is antibacterial. The coating 760 may be attached chemically to the surface 750.
An implantable medical device 10 does not need to be hollow in order to come into multiple parts of the body. For example, the implantable pumping device 10 describes in relation to
The coatings may comprise any type of substance with antithrombotic, antiplatelet or antibacterial features. Such substances include sortase A, perfluorocarbon and more.
The coatings presented in relation to the figures may also be combined with an implantable medical device comprising certain materials that are antibacterial or antithrombotic. For example, some metals have shown to be antibacterial. In case the implant, or at least the surfaces of the implant, are made out of such a metal it may be advantageous in order to reduce bacterial infections. The medical implant or the surface of the implant may be made out of any other suitable metal or material. The surface may for example comprise any of the following metals, or any combination of the following metals: titanium, cobalt, nickel, copper, zinc, zirconium, molybdenum, tin or lead.
An implantable medical device can also be coated with a slow releasing anti-fibrotic or antibacterial drug in order to prevent fibrin sheath creation and bacterial inflammation. The drug or medicament may be coated on the surface and be arranged to slowly be released from the implant in order to prevent the creation of fibrin or inflammation. The drug may also be covered in a porous or soluble material that slowly disintegrates in order to allow the drug to be administered into the body and prevent the creation of fibrin. The drug may be any conventional anti-fibrotic or antibacterial drug.
The micropattern may for example be etched into the surface 750 of the implantable medical device 10 prior to insertion into the body. The surface of the implantable medical device 10 may for example comprise a metal. The surface may for example comprise any of the following metals, or any combination of the following metals: titanium, cobalt, nickel, copper, zinc, zirconium, molybdenum, tin or lead. This may be advantageous in that these metals have proven to be antibacterial which may ensure that the implant functions better when inserted into the host body.
With reference to
The device 140 is configured to be held in position by a tissue portion 610 of a patient. The device 140 comprises a first portion 141′ configured to be placed on a first side 612 of the tissue portion 610, the first portion 141′ having a first cross-sectional area in a first plane and comprising a first surface configured to face and/or engage a first tissue surface 616 of the first side 612 of the tissue portion 610. The device 140 further comprises a second portion 141″ configured to be placed on a second side 618 of the tissue portion 610, the second side 618 opposing the first side 612, the second portion 141″ having a second cross-sectional area in a second plane and comprising a second surface configured to engage a second tissue surface 622 of the second side 618 of the tissue portion 610. The device 140 further comprises a connecting portion 142 configured to be placed through a hole in the tissue portion 610 extending between the first and second sides 612, 618 of the tissue portion 610. The connecting portion 142 here has a third cross-sectional area in a third plane. The connecting portion 142 is configured to connect the first portion 141′ to the second portion 141″. In the illustrated embodiment, a connecting interface 630 between the connecting portion 142 and the second portion 141″ is arranged at an end of the second portion 141″.
The first portion 141′ may have an elongated shape. Similarly, the second portion 141″ may have an elongated shape. However, the first portion 141′ and/or second portion 141″ may assume other shapes, such as a flat disk e.g. having a width and length being larger than the height, a sphere, an ellipsoid, or any other polyhedral or irregular shape, some of these being exemplified in
To provide a frame of reference for the following disclosure, and as illustrated in
The first portion 141′, connecting portion 142 and second portion 141″ may structurally form one integral unit. It is however also possible that the first portion 141′ and the connecting portion 142 structurally form one integral unit, while the second portion 141″ form a separate unit, or, that the second portion 141″ and the connecting portion 142 structurally form one integral unit, while the first portion 141′ form a separate unit.
Additionally, or alternatively, the second portion 141″ may comprise a removable and/or interchangeable portion 639 as described in other parts of the present disclosure.
In the following paragraphs, some features and properties of the second portion 141″ will be described. It is however to be understood that these features and properties may also apply to the first portion 141′.
The second portion 141″ has an intermediate region 638, and a distal region 640. A proximal region may be present, as described in other parts of the present disclosure, The intermediate region 638 is defined by the connecting interface 630 between the connecting portion 142 and the second portion 141″, and the distal region 640 extends from the connecting interface 630 between the connecting portion 142 and the second portion 141″ to the second end 634.
The first surface 614 configured to face and/or engage the first tissue surface 616 of the first side 612 of the tissue portion 610 may be substantially flat. In other words, the first portion 141′ may comprise a substantially flat side facing towards the tissue portion 610. Furthermore, an opposing surface of the first portion 141′, facing away from the tissue portion 610, may be substantially flat. Similarly, the second surface 620 configured to engage the second tissue surface 622 of the second side 618 of the tissue portion 610 may be substantially flat. In other words, the second portion 141″ may comprise a substantially flat side facing towards the tissue portion 610. Furthermore, an opposing surface of the second portion 141″, facing away from the tissue portion 610, may be substantially flat.
The second portion 141″ may be tapered from the first end 632 to the second end 634, thus giving the second portion 141″ different heights and/or widths along the length of the second portion 141″. The second portion may also be tapered from each of the first end 632 and second end 634 towards the intermediate region 638 of the second portion 141″.
Still referring to
In some embodiments, the lengthwise cross-sectional area may decrease over a majority of the length of the second portion towards the second end 634. In some embodiments, a decrease of the lengthwise cross-sectional area over at least ¼ of the length of the second portion towards the second end 634 may be sufficient. In the example illustrated in
With the second portion 141″ having rotational symmetry along the first direction 631, as illustrated for example in
As illustrated in
Referring now to
The different aspects or any part of an aspect or different embodiments or any part of an embodiment may all be combined in any possible way. Any method or any step of method may be seen also as an apparatus description, as well as, any apparatus embodiment, aspect or part of aspect or part of embodiment may be seen as a method description and all may be combined in any possible way down to the smallest detail. Any detailed description should be interpreted in its broadest outline as a general summary description, and please note that any embodiment or part of embodiment as well as any method or part of method could be combined in any way. All examples herein should be seen as part of the general description and therefore possible to combine in any way in general terms.
Communication and tamperproof soft- and hardware, where the display device allows for intuitive and easy use is provided. In the embodiments described with reference to
For creating a clasping fixation, the edges of the housing unit 320″ is made from an elastic material crating a tension between the edge 1528 and the display device 334 holding the display device 334 in place. The elastic material could be an elastic polymer material, or a thin sheet of elastic metal. For the purpose of further fixating the display device 334 in the housing unit 320″, the inner surface of the edges 1528 may optionally comprise a recess or protrusion (not shown) corresponding to a recess or protrusion of the outer surface of the display device 334. The edges 1528 may in the alterative comprise concave portions for creating a snap-lock clasping mechanical fixation between the housing unit 320″ and the display device 334.
In the embodiment shown in
In the embodiment shown with reference to
As mentioned, in the embodiment shown in
In an alternative embodiment, the second communication unit may be configured to communicate wirelessly with the implantable medical device using electromagnetic waves at a frequency below 100 kHz, or preferably at a frequency below 40 kHz. The second communication unit may thus be configured to communicate with the implantable medical device using “Very Low Frequency” communication (VLF). VLF signals have the ability to penetrate a titanium housing of the implant, such that the electronics of the implantable medical device can be completely encapsulated in a titanium housing. In yet further embodiments, the first and second communication units may be configured to communicate by means of an RFID type protocol, a WLAN type protocol, a BLE type protocol, a 3G/4G/5G type protocol, or a GSM type protocol.
In yet other alternative embodiments, it is conceivable that the mechanical connection between the housing unit 320″ and the display device 334 comprises an electrical connection for creating a wire-based communication channel between the housing unit 320″ and the display device 334. The electrical connection could also be configured to transfer electric energy from the display device 334 to the housing unit, such that the housing unit 320″ may be powered or charged by the display device 334. A wired connection is even harder to access for a non-authorized entity than an NFC-based wireless connection, which further increases the security of the communication between the housing unit 320″ and the display device 334.
In the embodiment shown with reference to
As mentioned, in the embodiment shown in
In alternative embodiments, the second communication unit of the display device 334 may be configured to communicate with the further external device by means of, a WLAN type protocol, or a 3G/4G/5G type protocol, or a GSM type protocol.
In the embodiment shown in
In the embodiment shown in
In the embodiment shown in
In the embodiment shown in
In the embodiment shown in
The implantable medical device 100 may be an active and/or operable implantable medical device 100 which may be an implantable medical device configured to exert a force on a body portion of the patient. The body portion of the patient may be a fluid carrying vessel, an organ, a joint, a membrane, a muscle, a bone or a nerve. The implantable medical device 100 may comprises an electrical motor and a controller for controlling the electrical motor and instructions transmitted to the implantable medical device 100 could be instructions pertaining to the control of the electrical motor. The controller may control, the velocity, the acceleration or the torque of the motor.
A system for mitigating fibrin creation caused by the contact between the implantable medical device and the tissue or flowing blood of a patient, will now be described with reference to
In the following, numbered aspect groups 352SE-364SE of the present invention are provided. The different aspects are numbered individually within the groups and the references to other aspects relate to aspects within the same group. The scope of protection is however defined by the appended claims.
Aspect group 352SE: Urine_Bladder_Pump_Neck
1. An implantable pumping device (10) for evacuating urine from the urinary bladder (U) of a patient, the implantable pumping device comprising:
2. The implantable pumping device according to aspect 1, wherein the controller is configured to control the first and second constriction device such that:
3. The implantable pumping device according to any one of aspects 1 and 2, wherein the controller is configured to receive a pressure signal from a pressure sensor 106 configured to measure the pressure in or exerted by at least one of the first and second constriction devices.
4. The implantable pumping device according to any one of aspects 1-3, wherein at least one of the first and second constriction device is a hydraulic constriction device.
5. The implantable pumping device according to any one of aspects 1-3, wherein at least one of the first and second constriction device is a mechanical constriction device.
6. The implantable pumping device according to any one of aspects 1-5, wherein at least one of the first and second constriction device is a constriction device configured to constrict by electrically stimulating at least one tissue wall of the urinary bladder.
7. The implantable pumping device according to any one of the preceding aspects, wherein the second constriction device is configured to constrict the second portion of the urinary bladder using electrical stimulation, and wherein the implantable pumping device further comprises a cancellation unit configured to be placed downstream the second portion, the cancellation unit being configured to cancel the electrical stimulation such that the urinary sphincter remains substantially unaffected by the electrical stimulation.
8. The implantable pumping device according to any one of the preceding aspects, wherein:
9. The implantable pumping device according to any one of the preceding aspects, wherein at least one of the first and second constriction device comprises at least one constriction element configured to contact a first portion of the urinary bladder and at least one abutment configured to contact a second portion of the urinary bladder and for withholding the force from the at least one constriction element, such that the urinary bladder is constricted between the at least one constriction element and the abutment.
10. The implantable pumping device according to any one of aspects 1-8, wherein at least one of the first and second constriction device comprises at least a first and a second constriction element, wherein the first constriction element is configured to contact a first portion of the urinary bladder and the second constriction element is configured to contact a second portion of the urinary bladder, such that the urinary bladder is constricted between the first and second constriction elements.
11. The implantable pumping device according to any one of aspects 9 and 10, further comprising a support element (24), and wherein at least one of the at least one constriction element and the at least one abutment is connected to the support element.
12. The implantable pumping device according to aspect 11, wherein the support element is configured to form at least a portion of a surrounding structure (20) configured to surround the urinary bladder.
13. The implantable pumping device according to aspect 11, wherein the support element comprises at least one fluid conduit (109) at least partially integrated in the support element.
14. The implantable pumping device according to any one of aspects 12-13, wherein the support element comprises a connection portion for connecting the support element to another support element for at least partially forming the surrounding structure.
15. The implantable pumping device according to aspect 14, wherein the support element comprises a portion of a hinge 27 for hingedly connecting the support element to other support element for at least partially forming the surrounding structure.
16. The implantable pumping device according to according to any one of the preceding aspects, wherein at least one of the support elements, the at least one abutment and the at least one constriction element comprises at least one curvature (C) adapted for the curvature of the urinary bladder.
17. The implantable pumping device according to according to any one of the preceding aspects, further comprising an electrode arrangement configured to engage and electrically stimulate muscle tissue of the urinary bladder to exercise the muscle tissue to improve the conditions for long term implantation of the implantable pumping device.
18. The implantable pumping device according to according to any one of aspects 9-17, wherein the abutment comprises at least one cushioning element (30) configured to contact the urinary bladder, wherein the cushioning element is more resilient than the support element of aspects 11-17.
19. The implantable pumping device according to according to any one of the preceding aspects, wherein:
20. The implantable pumping device according to according to any one of the preceding aspects, wherein the second constriction device comprises a plurality of constriction elements configured to sequentially constrict the urinary bladder for evacuating urine from the urinary bladder.
21. The implantable pumping device according to aspect 5, wherein the mechanical construction device comprises at least one mechanical constriction element (101a′) comprising an electric motor (M), a screw (701) and a plate (702), wherein the electric motor is configured to turn the screw in order to push the plate toward the urinary bladder in order to constrict the urinary bladder.
1. An implantable pumping device (10) for evacuating urine from the urinary bladder (U) of a patient, the implantable pumping device comprising:
2. The implantable pumping device according to aspect 1, further comprising electric stimulation device comprising electrodes (E1, E2, E3) provided on the constriction elements and configured to electrically stimulate the constricted portions with electric pulses.
3. The implantable pumping device according to aspect 2, wherein the electrodes are configured to stimulate the tissue of the urinary bladder in order to avoid damage to the tissue from the pressure of the constriction elements.
4. The implantable pumping device according to aspect 2, wherein the electrodes are configured to stimulate the tissue of the urinary bladder in order to thicken the tissue of the constricted portion in order to close the passageway of the urinary bladder.
5. The implantable pumping device according to any one of aspects 2-4, further comprising a cancellation unit configured to be placed downstream the rotor and the constriction elements, the cancellation unit being configured to cancel the electrical stimulation such that the urinary sphincter remains substantially unaffected by the electrical stimulation.
6. The implantable pumping device according to any one of the preceding aspects, wherein at least the constriction elements may comprise a coating (760) with antithrombotic and/or antibacterial characteristics.
7. The implantable pumping device according to aspect 6, wherein the coating comprises a biomaterial.
8. The implantable pumping device according to any one of the previous aspects, wherein at least the constriction elements comprises a micropattern etched into a surface of the constriction elements.
1. An implantable pumping device (10) for evacuating urine from the urinary bladder (U) of a patient, the implantable pumping device comprising:
2. The implantable pumping device (10) according to aspect 1, wherein a lumen (103a) of the first operable hydraulic constriction element (101a) has a larger volume than a lumen (103b) of the second operable hydraulic constriction element (101b).
3. The implantable pumping device (10) according to aspect 2, wherein the lumen (103a) of the first operable hydraulic constriction element (101a) has a volume which is more than 1,5 times larger than the volume of the lumen (103b) of the second operable hydraulic constriction element (101b).
4. The implantable pumping device (10) according to any one of the preceding aspects, wherein the first interconnecting fluid conduit (116) comprises a first electrically operable valve (119), such that a flow of fluid between the first operable hydraulic constriction element (101a) and the second operable hydraulic constriction element (101b) can be controlled.
5. The implantable pumping device (10) according to aspect 4, wherein the electrically operable valve (119) is a solenoid valve.
6. The implantable pumping device (10) according to any one of the preceding aspects, wherein the first interconnecting fluid conduit (116) comprises a check valve (114), such that fluid can flow in a direction from the first operable hydraulic constriction element (101a) to the second operable hydraulic constriction element (101b) but not in a direction from the second operable hydraulic constriction element (101b) to the first operable hydraulic constriction element (101a).
7. The implantable pumping device (10) according to any one of the preceding aspects, further comprising a second interconnecting fluid conduit (117) fluidly connecting the first operable hydraulic constriction element (101a) to the second operable hydraulic constriction element (101b), wherein a cross section of a tubular lumen of the second interconnecting fluid conduit (117) has an area which is less than 0.5 times a cross section area of a tubular lumen of the first interconnecting fluid conduit (116).
8. The implantable pumping device (10) according to any one of the preceding aspects, further comprising:
9. The implantable pumping device (10) according to aspect 8, wherein the first reservoir conduit (109′) comprises a second electrically operable valve (105), such that a flow of fluid between the reservoir (107) and the first operable hydraulic constriction element (101a) can be controlled.
10. The implantable pumping device (10) according to any one of aspects 8 and 9, further comprising a second reservoir conduit (109″) fluidly connecting the reservoir (107) to the second operable hydraulic constriction element (101b).
11. The implantable pumping device (10) according to aspect 10, wherein the second reservoir conduit (109″) comprises a check valve (113) such that fluid can flow in a direction from the reservoir (107) to the second operable hydraulic constriction element (101b) but not in a direction from the second operable hydraulic constriction element (101b) to the reservoir (107).
12. The implantable pumping device (10) according to any one of aspects 8-11, further comprising an injection port (108) in fluid connection with the reservoir (107), for injecting fluid into the reservoir (107) when the reservoir (107) is implanted.
13. The implantable pumping device (10) according to aspect 12, wherein the injection port (108) is configured to be placed subcutaneously, and wherein the implantable pumping device (10) further comprises an injection port conduit (110) fluidly connecting the injection port (108) to the reservoir (107).
14. The implantable pumping device (10) according to any one of the preceding aspects, further comprising at least one of:
15. The implantable pumping device (10) according to aspect 14, further comprising a controller (300) configured to receive a pressure sensor signal from at least one of the first and second pressure sensor (106′,106″), and control at least one of: the first electrically operable valve (119), the second operable valve and the hydraulic pump, on the basis of the received pressure sensor signal.
16. The implantable pumping device (10) according to aspect 15, wherein the controller (300) comprises a pressure threshold value, and wherein the controller (300) is configured to open the first electrically operable valve (119) if the received pressure sensor signal from the second pressure sensor (106″) exceeds the pressure threshold value.
17. The implantable pumping device (10) according to any one of the preceding aspects, further comprising a supporting operable hydraulic constriction element (201), wherein the supporting operable hydraulic constriction element (201) is configured to be placed along at least a portion of the first portion (p1) of the luminary organ (U) and along at least a portion of the second portion (p2) of the luminary organ (U), and configured to assist in the constriction of the first and second portions (p1,p2) of the urinary bladder (U).
18. The implantable pumping device (10) according to aspect 17, wherein the supporting operable hydraulic constriction element (201) is connected to the first and second operable hydraulic constriction elements (101a,101b).
19. The implantable pumping device (10) according to any one of aspects 17 and 18, wherein the supporting operable hydraulic constriction element (201) is less resilient than at least one of the first and second operable hydraulic constriction element (101a,101b).
20. The implantable pumping device (10) according to aspect 19, wherein each of the first, second and supporting operable hydraulic constriction element (101a,101b,201) comprises a lumen (103a,103b,203) surrounded by a resilient wall (102,202), and wherein the resilient wall (202) of the supporting operable hydraulic constriction element (201) is thicker than the wall (102) of at least one of the first and second operable hydraulic constriction element (101a,101b).
21. The implantable pumping device (10) according to any one of aspects 17-20, further comprising:
22. The implantable pumping device (10) according to any one of aspect 17-21, further comprising a third pressure sensor (206) configured to sense the pressure in the supporting operable hydraulic constriction element (201).
23. The implantable pumping device (10) according to any one of aspects 17-22, further comprising a second injection port (208) in fluid connection with the second reservoir (207), for injecting fluid into the second reservoir (207) when the second reservoir (207) is implanted.
24. The implantable pumping device (10) according to aspect 23, wherein the second injection port (208) is configured to be placed subcutaneously, and wherein the implantable pumping device (10) further comprises a second injection port conduit (210) fluidly connecting the second injection port (208) to the second reservoir (207).
25. The implantable pumping device (10) according to any one of aspects 17-24, wherein the supporting operable hydraulic constriction element (201) has a length (13) in the axial direction (AD) of the urinary bladder (U), when implanted, and wherein the first and second operable hydraulic constriction element (101a,101b) has a combined length (12) in the axial direction AD of the urinary bladder (U), and wherein the combined length (12) is longer than the length (13) of the supporting operable hydraulic constriction element (201).
26. The implantable pumping device (10) according to any one of the preceding aspects, wherein the implantable pumping device (10) comprises a surrounding structure (20) having a periphery surrounding the urinary bladder (U) when implanted.
27. The implantable pumping device (10) according to aspect 26, wherein the surrounding structure (20) is substantially rigid.
28. The implantable pumping device (10) according to aspect 27, wherein a major portion of the surrounding structure (20) is made from a material having a modulus of elasticity (E) in the range 0.2 GPa-1000 GPa or in the range 1 GPa-400 GPa.
29. The implantable pumping device (10) according to aspect 27, wherein the surrounding structure (20) has a modulus of elasticity (E), radially, in the range 0,2 GPa-1000 GPa or in the range 1 GPa-400 GPa.
30. The implantable pumping device (10) according to any one of aspects 26-29, wherein the surrounding structure (20) comprises an inner surface (22) configured to face the urinary bladder (U), when implanted, and wherein the supporting operable hydraulic constriction device (201) is fixated to the inner surface (22) of the surrounding structure (20), such that the supporting operable hydraulic constriction device (201) can use the surrounding structure (20) as support for constricting the urinary bladder (U).
31. The implantable pumping device (10) according to any one of aspects 26-30, further comprising at least one cushioning element (30) configured to contact the urinary bladder (U), wherein the cushioning element (30) is fixated to the inner surface (22) of the surrounding structure (20) and is more resilient than the surrounding structure (20).
32. The implantable pumping device (10) according to any one of aspects 26-31, wherein the surrounding structure (20) is comprised of at least a first and a second supporting element configured to be connected to each other for forming at least a portion of the periphery of the surrounding structure (20).
33. The implantable pumping device (10) according to aspect 32, wherein the supporting operable hydraulic constriction device (201) is fixated to the first supporting element, and the at least one cushioning element (30) is fixated to the second supporting element.
34. The implantable pumping device (10) according to any one of aspects 32 and 33, wherein at least one of the first and second supporting elements have a curvature adapted for the curvature of the urinary bladder (U).
35. The implantable pumping device (10) according to aspect 34, wherein the curvature has a radius in the range 15 mm-60 mm.
36. The implantable pumping device (10) according to aspect 34, wherein the curvature has a radius in the range 20 mm-50 mm.
37. The implantable pumping device (10) according to any one of the preceding aspects, wherein the implantable pumping device (10) further comprises an electrode arrangement configured to be arranged between the implantable constriction device (10) and the urinary bladder (U) and configured to engage and electrically stimulate muscle tissue of the urinary bladder (U) to exercise the muscle tissue to improve the conditions for long term implantation of the implantable pumping device (10).
1. An implantable pumping device (10) for evacuating urine from a urinary bladder (U) of a patient, the implantable pumping device comprises:
2. The implantable pumping device (10) according to aspect 1, wherein the supporting operable hydraulic constriction element (201) is connected to the first operable hydraulic constriction element (101).
3. The implantable pumping device (10) according to any one of preceding aspects, wherein the supporting operable hydraulic constriction element (201) is less resilient than the first operable hydraulic constriction element (101).
4. The implantable pumping device (10) according to aspect 3, wherein the first operable hydraulic constriction element (101) comprises a lumen (103) surrounded by a resilient wall (102) and the supporting operable hydraulic constriction element (201) comprises a lumen (203) surrounded by a resilient wall (202), and wherein a portion of the resilient wall (202) of the supporting operable hydraulic constriction element (201) is thicker than a portion of the resilient wall (102) of the first operable hydraulic constriction element (101).
5. The implantable pumping device (10) according to aspect 4, wherein a portion of the resilient wall (202) of the supporting operable hydraulic constriction element (201) is more than 1,5 times thicker than a portion of the resilient wall (102) of the first operable hydraulic constriction element (101).
6. The implantable pumping device (10) according to aspect 4, wherein a portion of the resilient wall (202) of the supporting operable hydraulic constriction element (201) is more than 2 times thicker than a portion of the resilient wall (102) of the first operable hydraulic constriction element (101).
7. The implantable pumping device (10) according to any one of aspects 3-6, wherein the first operable hydraulic constriction element (101) comprises a lumen (103) surrounded by a resilient wall (102) and the supporting operable hydraulic constriction element (201) comprises a lumen (203) surrounded by a resilient wall (202), and wherein
8. The implantable pumping device (10) according to aspect 7, wherein the modulus of elasticity of the second material is more than 1,5 times higher than the modulus of elasticity of the first material.
9. The implantable pumping device (10) according to aspect 7, wherein the modulus of elasticity of the second material is more than 2 times higher than the modulus of elasticity of the first material.
10. The implantable pumping device (10) according to any one of aspects 1-4, further comprising:
11. The implantable pumping device (10) according to any one of aspect 1-10, further comprising a first pressure sensor (106) configured to sense the pressure in the first operable hydraulic constriction element (101).
12. The implantable pumping device (10) according to any one of aspect 1-11, further comprising a second pressure sensor (206) configured to sense the pressure in the supporting operable hydraulic constriction element (201).
13. The implantable pumping device (10) according to any one of aspect 11-12, further comprising an implantable controller (300), wherein the implantable controller (300) is configured to control at least one of the:
14. The implantable pumping device (10) according to aspect 13, wherein at least one of:
15. The implantable pumping device (10) according to any one of aspects 10-12, wherein at least one of:
16. The implantable pumping device (10) according to any one of aspect 1-15, further comprising a first injection port (108) in fluid connection with the first reservoir (107), for injecting fluid into the first reservoir (107) when the first reservoir is implanted.
17. The implantable pumping device (10) according to any one of aspect 1-16, further comprising a second injection port (208) in fluid connection with the second reservoir (207), for injecting fluid into the second reservoir (207) when the second reservoir (207) is implanted.
18. The implantable pumping device (10) according to any one of aspects 16 and 17, wherein at least one of:
19. The implantable pumping device (10) according to any one of the preceding aspects, wherein the supporting operable hydraulic constriction element (201) has a length (13) in the axial direction (AD) of the urinary bladder (U), when implanted, and wherein the first operable hydraulic constriction element (101) has a length (12) in the axial direction (AD) of the urinary bladder (U), and wherein the length of the first operable hydraulic constriction element (12) is longer than the length (13) of the supporting operable hydraulic constriction element (201).
20. The implantable pumping device (10) according to any one of the preceding aspects, wherein the implantable pumping device (10) comprises a surrounding structure (20) having a periphery surrounding the urinary bladder (U) when implanted.
21. The implantable pumping device (10) according to aspect 20, wherein the surrounding structure (20) is substantially rigid.
22. The implantable pumping device (10) according to aspect 21, wherein a major portion of the surrounding structure (20) is made from a material having a modulus of elasticity (E) in the range 0.2 GPa-1000 GPa or in the range 1 GPa-400 GPa.
23. The implantable pumping device (10) according to aspect 21, wherein the surrounding structure (20) has a modulus of elasticity (E), radially, in the range 0,2 GPa-1000 GPa or in the range 1 GPa-400 GPa.
24. The implantable pumping device (10) according to any one of aspects 20-23, wherein the surrounding structure (20) comprises an inner surface (22) configured to face the luminary organ (U), when implanted, and wherein the supporting operable hydraulic constriction device (201) is fixated to the inner surface (22) of the surrounding structure (20), such that the supporting operable hydraulic constriction device (201) can use the surrounding structure (20) as support for constricting the urinary bladder (U).
25. The implantable pumping device (10) according to any one of aspects 20-24, further comprising at least one cushioning element (30) configured to contact the urinary bladder (U), wherein the cushioning element (30) is fixated to the inner surface (22) of the surrounding structure (20) and is more resilient than the surrounding structure (20).
26. The implantable pumping device (10) according to any one of aspects 20-25, wherein the surrounding structure (20) is comprised of at least a first and a second supporting element configured to be connected to each other for forming at least a portion of the periphery of the surrounding structure (20).
27. The implantable pumping device (10) according to aspect 26, wherein the supporting operable hydraulic constriction device (201) is fixated to the first supporting element, and the at least one cushioning element (30) is fixated to the second supporting element.
28. The implantable pumping device (10) according to any one of aspects 26 and 27, wherein at least one of the first and second supporting element have a curvature adapted for the curvature of the urinary bladder (U).
29. The implantable pumping device (10) according to aspect 28, wherein the curvature has a radius in the range 15 mm-60 mm.
30. The implantable pumping device (10) according to aspect 28, wherein the curvature has a radius in the range 20 mm-50 mm.
31. The implantable pumping device (10) according to any one of the preceding aspects, wherein the implantable pumping device (10) further comprises an electrode arrangement configured to be arranged between the implantable pumping device (10) and the urinary bladder (U) and configured to engage and electrically stimulate muscle tissue of the urinary bladder (U) to exercise the muscle tissue to improve the conditions for long term implantation of the implantable pumping device (10).
1. An implantable pumping device (10) for evacuating urine from a urinary bladder (U) of a patient, the implantable pumping device comprises:
2. The implantable pumping device (10) according to aspect 1, wherein the second direction (d2) is substantially opposite to the first direction (d1).
3. The implantable pumping device (10) according to any one of the preceding aspects, wherein the first hydraulic system comprises a first hydraulic pump (104′) and the second hydraulic system comprises a second hydraulic pump (104″), and wherein the third hydraulic system comprises a third hydraulic pump (104″′) and the fourth hydraulic system comprises a fourth hydraulic pump (104″″).
4. The implantable pumping device (10) according to any one of the preceding aspects, wherein each of the first, second, third and fourth hydraulic systems comprises a reservoir (107) for holding hydraulic fluid.
5. The implantable pumping device (10) according to any one of the aspects 1-3, wherein the first, second, third and fourth hydraulic systems are connected to a reservoir (107) for holding hydraulic fluid.
6. The implantable pumping device (10) according to any one of the preceding aspects, wherein each of the first, second, third and fourth hydraulic systems comprises an injection port (108) for injecting hydraulic fluid into the respective first and second hydraulic systems.
7. The implantable pumping device (10) according to aspect 6, wherein the injection ports (108) is configured to be placed subcutaneously, and wherein the implantable pumping device (10) further comprises an injection port conduit (110) fluidly connecting the injection ports (108) to the first, second, third and fourth hydraulic systems.
8. The implantable pumping device (10) according to any one of the preceding aspects, wherein the first operable hydraulic constriction element (101a′) lacks a fluid connection to the second operable hydraulic constriction element (101a″), and wherein the third operable hydraulic constriction element (101b′) lacks a fluid connection to the fourth operable hydraulic constriction element (101b″).
9. The implantable pumping device (10) according to any one of the preceding aspects, further comprising at least one of:
10. The implantable pumping device (10) according to aspect 9, further comprising a controller (300) configured to receive a pressure sensor signal from at least one of the first, second, third and fourth pressure sensor, and control at least one of: the first hydraulic pump (104′), the second hydraulic pump (104″), the third hydraulic pump and the fourth hydraulic pump on the basis of the received pressure sensor signal.
11. The implantable pumping device (10) according to any one of the preceding aspects, wherein the implantable pumping device (10) comprises a surrounding structure (20) having a periphery surrounding the urinary bladder (U) when implanted.
12. The implantable pumping device (10) according to aspect 11, wherein the surrounding structure (20) is substantially rigid.
13. The implantable pumping device (10) according to aspect 12, wherein a major portion of the surrounding structure (20) is made from a material having a modulus of elasticity (E) in the range 0.2 GPa-1000 GPa or in the range 1 GPa-400 GPa.
14. The implantable pumping device (10) according to aspect 12, wherein the surrounding structure (20) has a modulus of elasticity (E), radially, in the range 0,2 GPa-1000 GPa or in the range 1 GPa-400 GPa.
15. The implantable pumping device (10) according to any one of aspects 11-14, wherein the surrounding structure (20) comprises an inner surface (22) configured to face the urinary bladder (U), when implanted, and wherein the first, second, third and fourth operable hydraulic constriction element (101a′,101a″, 101b′,101b″) are fixated to the inner surface (22) of the surrounding structure (20).
16. The implantable pumping device (10) according to any one of aspects 11-15, wherein the surrounding structure (20) is comprised of at least a first and a second support element (24a,24b) configured to be connected to each other for forming at least a portion of the periphery (P) of the surrounding structure (20).
17. The implantable pumping device (10) according to aspect 16, wherein the first and third operable hydraulic constriction elements (101a′, 101b′) are fixated to the first support element (24a), and the second and fourth operable hydraulic constriction elements (101a″, 101b″) are fixated to the second support element (24b).
18. The implantable pumping device (10) according to any one of aspects 16 and 17, wherein at least one of the first and second support elements (24a,24b) have a curvature (C) adapted for the curvature of the urinary bladder (U).
19. The implantable pumping device (10) according to aspect 18, wherein the curvature (C) has a radius (R) in the range 15 mm-60 mm.
20. The implantable pumping device (10) according to any one of the preceding aspects, wherein the implantable pumping device (10) further comprises an electrode arrangement configured to be arranged between the implantable pumping device (10) and the urinary bladder (U) and configured to engage and electrically stimulate muscle tissue of the urinary bladder (U) to exercise the muscle tissue to improve the conditions for long term implantation of the implantable pumping device (10).
1. An implantable pumping device (10) for evacuating urine from the urinary bladder (U) of a patient, the implantable pumping device (10) comprises:
2. The implantable pumping device (10) according to aspect 1, wherein the electrode arrangement is arranged on an outer surface of at least one of the operable hydraulic constriction element (101a) and the second operable hydraulic constriction element (101b).
3. The implantable pumping device (10) according to aspect 1 or 2, wherein the electrode arrangement comprises a plurality of electrode elements (E1,E2,E3,E4), each of which being configured to engage and electrically stimulate tissue of the urinary bladder (U).
4. The implantable pumping device (10) according to any of the preceding aspects, wherein the electrode arrangement comprises a coiled wire for increasing a contact surface between the electrode arrangement and the tissue of the urinary bladder (U) and for allowing the electrode arrangement to follow contraction and relaxation of the tissue of the urinary bladder (U).
5. The implantable pumping device (10) according to any of the preceding aspects, wherein the electrode arrangement comprises a bare electrode portion configured to form a metal-tissue interface with the tissue of the urinary bladder (U), thereby allowing faradaic charge transfer to the be predominant charge transfer mechanism over said interface.
6. The implantable pumping device (10) according to any of the preceding aspects, wherein the electrode arrangement comprises an electrode portion at least partly covered by a dielectric material configured to form a dielectric-tissue interface with the tissue of the urinary bladder (U), thereby allowing for a faradaic portion of the charge transfer mechanism over said interface to be reduced.
7. The implantable pumping device (10) according to any one of the preceding aspects, wherein the electrode arrangement comprises at least two electrode elements (E1,E2,E3,E4) configured to be arranged on opposing sides of the urinary bladder (U).
8. The implantable pumping device (10) according to any of the preceding aspects, further comprising a stimulation controller (350) configured to be operably connected to the electrode arrangement for controlling the electrical stimulation of the tissue of the urinary bladder (U).
9. The implantable pumping device (10) according to aspect 9, wherein the stimulation controller (350) is configured to control the electrical stimulation such that the tissue of the urinary bladder (U) is stimulated by a series of electrical pulses.
10. The implantable pumping device (10) according to aspect 10, wherein the stimulation controller (350) is configured to control the electrical stimulation such that a pulse of a first polarity is followed by a pulse of a second, reversed polarity.
11. The implantable pumping device (10) according to any of aspects 8-10, wherein the stimulation controller (350) is configured to generate a pulsed electrical stimulation signal comprising a pulse frequency of 0.01-150 Hz.
12. The implantable pumping device (10) according to aspect 11, wherein the electrical stimulation signal comprises a pulse duration of 0.01-100 ms.
13. The implantable pumping device (10) according to aspect 11 or 12, wherein the electrical stimulation signal comprises a pulse amplitude of 1-15 mA.
14. The implantable pumping device (10) according to any of aspects 11-13, wherein the electrical stimulation signal comprises a pulse frequency of 0.15-0.25 Hz, a pulse duration of 20-30 ms and a pulse amplitude of 3-10 mA.
15. The implantable pumping device (10) according to any of aspects 11-14, wherein the electrical stimulation signal comprises a build-up period of 0.01-2 s in which the amplitude is gradually increasing, a stimulation period of 1-60 s, and a stimulation pause of 0.01-60 s, wherein the electrical signal comprises a pulse frequency of 1-50 Hz and a pulse duration of 0.1-10 ms.
16. The implantable pumping device (10) according to any of aspects 8-15, wherein the stimulation controller (350) is configured to receive input from a wireless remote control.
17. The implantable pumping device (10) according to any of aspects 8-16, further comprising an implantable sensor configured to sense actions potentials generated by pacemaker cells of the tissue of the urinary bladder (U), and wherein the stimulation controller (350) is configured to control the electrical simulation based at least partly on the sensed action potentials.
18. The implantable pumping device (10) according to aspect 17, wherein the stimulation controller (350) is configured to generate electrical pulses amplifying the sensed action potentials.
19. The implantable pumping device (10) according to any one of the preceding aspects, wherein the implantable constriction device (10a) comprises a surrounding structure (20) having a periphery surrounding the urinary bladder (U) when implanted.
20. The implantable pumping device (10) according to aspect 19, wherein the electrode arrangement is connected to the surrounding structure (20).
21. The implantable pumping device (10) according to aspect 20, wherein the surrounding structure (20) comprises at least one cushioning element (30), and wherein at least one electrode element (E1,E2,E3,E4) of the electrode arrangement is placed on the surface of the cushioning element (30).
1. An implantable pumping device (10) for evacuating urine from the urinary bladder (U) of a patient, the implantable pumping device comprises:
2. The implantable pumping device (10) according to aspect 1, wherein the motor (M) of the first and/or second constriction device (10a,10b) is an electrical motor.
3. The implantable pumping device (10) according to aspect 2, wherein the motor (M) is a brushless implantable DC motor.
4. The implantable pumping device (10) according to any one of aspects 1-3, further comprising a gear system (G) placed between the motor (M) and the first and second hydraulic pump (104, 204), and wherein the gear system (G) is configured to reduce the velocity and increase the force of the movement generated by the motor (M) for propelling the first and second hydraulic pump (104, 204) with a mechanical force with a lower velocity and a greater force.
5. The implantable pumping device (10) according to any one of the preceding aspects, wherein the motor (M) is configured to generate a rotating force and propel the first and second hydraulic pump (104, 204) with a rotating mechanical force.
6. The implantable pumping device (10a) according to aspect 5, wherein a rotating force output of the motor (M) is connected to a force input of the gear system (G), and a rotating force output of the gear system (G) is connected to the first and second hydraulic pump (104, 204).
7. The implantable pumping device (10) according to any one of the preceding aspects, wherein at least one of the first and second hydraulic pump (104, 204) of the first constriction device (10a) and/or the second constriction device (10b) comprises a gear pump.
8. The implantable pumping device (10) according to any one of the preceding aspects, wherein at least one of the first and second hydraulic pump (104, 204) of the first constriction device (10a) and/or the second constriction device (10b) comprises a peristaltic pump.
9. The implantable pumping device (10) according to any one of the preceding aspects, wherein at least one of the first and second hydraulic pump (104, 204) of the first constriction device (10a) and/or the second constriction device (10b) comprises a pump comprising at least one compressible hydraulic reservoir (107a, 107b).
10. The implantable pumping device (10) according to any one of the preceding aspects, wherein at least one of the first and second hydraulic pump (104, 204) of the first constriction device (10a) and/or the second constriction device (10b) comprises a gerotor pump (460).
11. The implantable pumping device (10) according to aspect 10, wherein:
12. The implantable pumping device (10) according to any one of the preceding aspects, further comprising an implantable reservoir (107), and wherein at least one of the first and second hydraulic pump (104, 204) of the first constriction device (10a) and/or the second constriction device (10b) is connected to the implantable reservoir.
13. The implantable pumping device (10) according to any one of aspects 1-11, wherein the first constriction device (10a) and/or the second constriction device (10b) further comprises a first implantable reservoir (107) and a second implantable reservoir (207), and wherein the first hydraulic pump (104) is connected to the first implantable reservoir, and the second hydraulic pump (204) is connected to the second implantable reservoir.
14. The implantable pumping device (10a) according to any one of aspects 1-11, wherein the first constriction device (10a) and/or the second constriction device (10b) further comprises an implantable reservoir (107), and wherein the first and second hydraulic pump (104,204) is connected to the implantable reservoir, for pumping hydraulic fluid from the first reservoir to the first operable hydraulic constriction element (101a) and from the second reservoir to the second operable hydraulic constriction element (201).
15. The implantable pumping device (10) according to any one of the preceding aspects, wherein the first operable hydraulic constriction element (101a) of the first constriction device (10a) is configured to be inflated and thereby expand in a first direction (d1) towards the urinary bladder (U) to constrict a first portion (p1) of the luminary organ (U) for restricting the flow of fluid therethrough, and the second operable hydraulic constriction element (201) of the first constriction device (10a) is a supporting operable hydraulic constriction element (201) configured to be inflated and thereby expand in the first direction (d1) towards the urinary bladder (U) to support the first operable hydraulic constriction element (101a) in constricting the first portion (p1) of the urinary bladder (U) for restricting the flow of fluid therethrough.
16. The implantable pumping device (10) according to any one of the preceding aspects, wherein the first operable hydraulic constriction element (101a) of the second constriction device (10b) is configured to be inflated and thereby expand in a first direction (d1) towards the urinary bladder (U) to constrict a second portion (p2) of the luminary organ (U) for restricting the flow of fluid therethrough and for evacuating urine from the urinary bladder (U), and the second operable hydraulic constriction element (201) of the second constriction device (10b) is a supporting operable hydraulic constriction element (201) configured to be inflated and thereby expand in the first direction (d1) towards the urinary bladder (U) to support the first operable hydraulic constriction element (101a) in constricting the first portion (p2) of the urinary bladder (U) for restricting the flow of fluid therethrough and for evacuating urine from the urinary bladder (U).
17. The implantable pumping device (10) according to aspect 15 or 16, wherein the supporting operable hydraulic constriction element (201) is connected to the first operable hydraulic constriction element (101a).
18. The implantable pumping device (10) according to any one of aspects 15-17, wherein the supporting operable hydraulic constriction element (201) is less resilient than the first operable hydraulic constriction element (101a).
19. The implantable pumping device (10) according to aspect 18, wherein the first operable hydraulic constriction element (101a) of the first constriction device (10a) and/or the second constriction device (10b) comprises a lumen (103) surrounded by a resilient wall (102) and the supporting operable hydraulic constriction element (201) comprises a lumen (203) surrounded by a resilient wall (202), and wherein a portion of the resilient wall (202) of the supporting operable hydraulic constriction element (201) is thicker than a portion of the resilient wall (102) of the first operable hydraulic constriction element (101a).
20. The implantable pumping device (10) according to any one of the preceding aspects, wherein the first constriction device (10a) and/or the second constriction device (10b) further comprises a first pressure sensor (106) configured to sense the pressure in the first operable hydraulic constriction element (101a).
21. The implantable pumping device (10) according to any one of the preceding aspects, wherein the first constriction device (10a) and/or the second constriction device (10b) further comprises a second pressure sensor (206) configured to sense the pressure in the second operable hydraulic constriction element (201).
22. The implantable pumping device (10) according to any one of aspect 20-21, further comprising an implantable controller (300), wherein the implantable controller (300) is configured to control at least one of the:
23. The implantable pumping device (10) according to any one of the preceding aspects, wherein the first constriction device (10a) and/or the second constriction device (10b) further comprises a first implantable injection port (108) in fluid connection with the first operable hydraulic constriction element (101a).
24. The implantable pumping device (10) according to any one of the preceding aspects, wherein the first constriction device (10a) and/or the second constriction device (10b) further comprises a second implantable injection port (208) in fluid connection with the second operable hydraulic constriction element (201).
1. An implantable pumping device (10) for evacuating urine from the urinary bladder (U) of a patient, the implantable pumping device comprises
2. The implantable pumping device (10) according to aspect 1, wherein the implantable energy storage unit (40) is a re-chargeable battery (40).
3. The implantable pumping device (10) according to aspect 1, wherein the implantable energy storage unit (40) is a solid-state battery.
4. The implantable pumping device (10) according to aspect 3, wherein the battery (40) is a tionyl-chlorid battery.
5. The implantable pumping device (10) according to any one of the preceding aspects, wherein the implantable energy storage unit (40) is connected to at least one of the first and second hydraulic pump (104a, 10b) and configured to power the first and/or second hydraulic pump (104b) after it has been started using the capacitor (397).
6. The implantable pumping device (10) according to any one of the preceding aspects, wherein the capacitor (397) is configured to store energy to provide a burst of energy to at least one of the first and second hydraulic pump (104a,104b).
7. The implantable pumping device (10) according to any one of the preceding aspects, wherein the capacitor (397) is a start capacitor.
8. The implantable pumping device (10) according to any one of the preceding aspects, wherein the capacitor (397) is a run capacitor.
9. The implantable pumping device (10) according to any one of the preceding aspects, wherein the capacitor (397) is a dual run capacitor.
10. The implantable pumping device (10) according to any one of the preceding aspects, further comprising a second capacitor configured to be charged by the implantable energy storage unit (40) and to provide at least one of the first and second hydraulic pump (104a, 104b) with electrical power.
11. The implantable pumping device (10) according to any one of the preceding aspects, wherein the capacitor (397) is a supercapacitor.
12. The implantable pumping device (10) according to any one of the preceding aspects, wherein at least one of the first and second hydraulic pump (104a,104b) comprises an electrical motor (M) for operating the hydraulic pump (104).
13. The implantable pumping device (10) according to any one of the preceding aspects, wherein the capacitor (397) is further configured to provide electrical power to at least one of:
14. The implantable pumping device (10) according to any one of the preceding aspects, wherein the capacitor (397) is further configured to provide electrical power to a valve (105).
15. The implantable pumping device (10) according to any one of the preceding aspects, wherein the capacitor (397) is further configured to provide electrical power to a controller (300) for controlling at least a part of the implantable pumping device (10).
16. The implantable pumping device (10) according to any one of the preceding aspects, further comprising:
17. The implantable pumping device (10) according to any one of the preceding aspects, further comprising a temperature sensor (351) for sensing a temperature of the implantable energy storage unit (40).
18. The implantable pumping device (10) according to any one of the preceding aspects, further comprising a temperature sensor (351) for sensing a temperature of the capacitor (397).
1. An implantable pumping device (10) for evacuating urine from a urinary bladder (U) of a patient, the implantable pumping device (10) comprises:
2. The implantable pumping device (10) according to any one of the preceding aspects, wherein the sensor (150) is at least one of: a hall effect sensor, a fluxgate sensor, an ultra-sensitive magnetic field sensor or a magneto-resistive sensor.
3. The implantable pumping device (10) according to any one of the preceding aspects, wherein the frequency of the magnetic field generated by the coil is 9-315 kHz.
4. The implantable pumping device (10) according to any one of the preceding aspects, wherein the frequency of the magnetic field generated by the coil is less than or equal to 125 kHz, preferably less than 58 kHz.
5. The implantable pumping device (10) according to any one of the preceding aspects, wherein the controller (300) comprises a receiver unit (303), and wherein the controller (300) and the external control unit are configured to transmit and/or receive data via the receiver unit (303) and the first coil via magnetic induction.
6. The implantable pumping device (10) according to aspect 5, wherein the receiver unit (303) comprises a high-sensitivity magnetic field detector (150).
7. The implantable pumping device (10) according to aspect 5, wherein the receiver unit (303) comprises a second coil.
8. The implantable pumping device (10) according to aspect 7, further comprising an implantable energy storage unit (40) electrically connected to the receiver unit (303), wherein the implantable energy storage (40) unit is adapted to be charged by the external control unit (320) via the receiver unit (395).
9. The implantable pumping device (10) according to aspect 7, wherein the implantable energy storage unit (40) is configured to be charged via magnetic induction between the first and the second coils.
10. The implantable pumping device (10) according to any one of aspects 8-9, wherein the receiver unit (395) is configured to control the charging of the implantable energy storage unit (40) by controlling a receipt of electrical power from the external control unit (320) at the receiver unit (395).
11. The implantable pumping device (10) according to any one of aspects 8-10, wherein the internal receiver unit (395) is configured to control the charging of the implantable energy storage unit (40) by controlling a transmission of electrical power from the external control unit (320) to the receiver unit (395).
12. The implantable pumping device (10) according to any one of the preceding aspects, further comprising a sensation generator (381) adapted to generate a sensation detectable by a sense of the patient, the sensation generator (381) being connected to the controller (300) or the external control unit (320), and being configured to, upon request, generate the sensation when implanted in a patient.
13. The implantable pumping device (10) according to aspect 12, wherein the sensation generator (381) is configured to receive the request from the controller (300) or the implantable pumping device (10).
14. The implantable pumping device (10) according to any one of aspects 12-13, wherein the sensation generator (381) is configured to receive the request from an external device (320).
15. The implantable pumping device (10) according to any one of aspects 12-14, wherein the sensation generator (381) is configured to create the sensation comprising a plurality of sensation components.
16. The implantable pumping device (10) according to any one of aspects 12-15, wherein the sensation generator (381) is configured to create the sensation or sensation components by at least one of:
17. The implantable pumping device (10) according to any one of aspects 12-16, wherein the sensation generator (381) is adapted to be implanted in the patient.
18. The implantable pumping device (10) according to any one of aspects 12-16, wherein the sensation generator (381) is configured to be worn in contact with the skin of the patient.
19. The implantable pumping device (10) according to any one of aspects 12-16, wherein the sensation generator (381) is configured generate the sensation without being in physical contact with the patient.
20. The implantable pumping device (10) according to any one of the preceding aspects, wherein the external control unit (320) comprises a wireless remote control.
21. The implantable pumping device (10) according to aspect 20, wherein the wireless remote control comprises an external signal transmitter (390), and wherein the internal receiver is further configured to receive a signal transmitted by the external signal transmitter (323, 390) and to control an operation of the apparatus based on said signal, when the processing unit (306) is in the active state.
22. The implantable pumping device (10) according to aspect 21 wherein the signal is selected from the group consisting of: a sound signal, an ultrasound signal, an electromagnetic signal, and infrared signal, a visible light signal, an ultraviolet light signal, a laser signal, a microwave signal, a radio wave signal, an X-ray radiation signal and a gamma radiation signal.
1. A method of implanting an implantable pumping device, the method comprises the steps of:
2. The method according to aspect 1, wherein the step of inserting an implantable pumping device into the body of the patient comprises inserting an implantable pumping device comprising a first, second and third luminary organ contacting element, wherein:
3. The method according to aspect 1, wherein the step of inserting an implantable pumping device into the body of the patient comprises inserting an implantable pumping device comprising:
4. The method according to aspect 1, wherein the step of inserting an implantable pumping device into the body of the patient comprises inserting an implantable pumping device comprising:
5. The method according to aspect 1, wherein the step of inserting an implantable pumping device into the body of the patient comprises inserting an implantable pumping device comprising at least two implantable constriction devices each comprising:
6. The method according to aspect 1, wherein the step of inserting an implantable pumping device into the body of the patient comprises inserting an implantable pumping device (10) comprising at least two implantable constriction devices (10a, 10b) each comprising:
7. The method according to aspect 1, wherein the step of inserting an implantable pumping device into the body of the patient inserting an implantable pumping device (10) comprising at least two implantable constriction devices (10a, 10b) each comprising:
8. The method according to aspect 1, wherein the step of inserting an implantable pumping device into the body of the patient comprises inserting an implantable pumping device (10) comprising at least two implantable constriction devices (10a, 10b) each comprising:
9. The method according to aspect 1, wherein the step of inserting an implantable pumping device into the body of the patient comprises inserting an implantable pumping device (10) comprising at least two implantable constriction devices (10a, 10b) each comprising:
10. The method according to aspect 1, wherein the step of inserting an implantable pumping device into the body of the patient comprises inserting an implantable pumping device (10) comprising at least two implantable constriction devices (10a, 10b) each comprising:
11. The method according to aspect 1, wherein the step of inserting an implantable pumping device into the body of the patient comprises inserting an implantable pumping devices (10) comprising at least two implantable constriction devices (10a, 10b) each comprising at least one implantable operable hydraulic constriction element (101) comprising:
12. The method according to aspect 1, wherein the step of inserting an implantable pumping device into the body of the patient comprises inserting an implantable pumping device (10) comprising at least two implantable constriction devices (10a, 10b) each comprising:
13. The method according to aspect 1, wherein the step of inserting an implantable pumping device into the body of the patient comprises inserting an implantable pumping device (10) comprising at least two implantable constriction devices (10a, 10b) each comprising:
14. The method according to any one of the preceding aspects, wherein the step of placing the implantable pumping device (10) in connection with the urinary bladder (U) comprises placing the implantable pumping device (10) around the urinary bladder (U) of the patient.
15. The method according to any one of the preceding aspects, wherein the step of placing the implantable pumping device in connection with the urinary bladder (U) comprises closing a locking or fixation device of the implantable pumping device (10) around the urinary bladder (U) (M5) to fixate the implantable pumping device (10) to the urinary bladder (U) of the patient. 16. The method according to any one of the preceding aspects, wherein the step of placing the implantable pumping device (10) in connection with the urinary bladder (U) comprises securing the implantable pumping device (10) by means of at least one of sutures, staples and tissue growth promoting structure (M6).
17. The method according to any one of the preceding aspects, wherein the step of inserting an implantable pumping device (10) into the body of the patient comprises inserting an implantable controller (300) into the body of the patient and fixating the implantable controller (300) to tissue or bone in the body of the patient.
18. The method according to any one of the preceding aspects, wherein the step of inserting an implantable pumping device (10) into the body of the patient comprises inserting an operation device comprising at least one of: an implantable hydraulic pump (104) and an implantable valve (105) and fixating the implantable operation device to tissue or bone in the body of the patient.
19. The method according to aspect 18, further comprising the step of implanting and fixating at least one injection port (108) in fluid connection with the operation device (M7).
20. The method according to aspect 19, wherein the step of fixating the at least one injection port (108) comprises the step of fixating the injection port subcutaneously.
21. The method according to aspect 19, further comprising the step of calibrating the fluid level in the implantable pumping device (10) (M8).
22. The method according to any one of the preceding aspects, further comprising calibrating at least one of:
23. The method according to any one of the preceding aspects, further comprising testing at least one of:
24. The method according to aspect 1, further comprising:
25. The method according to aspect 24, wherein the transferring member is configured to transfer mechanical force from the second portion to the implantable pumping device.
26. The method according to aspect 24, wherein the transferring member is configured to transfer hydraulic force from the second portion to the implantable pumping device.
27. The method according to aspects 24-26, wherein the transferring member is configured to transfer electrical energy force from the second portion to the implantable pumping device.
28. The method according to aspects 24-27, wherein the transferring member is configured to transfer data between the second portion and the body engaging portion.
1. A method in an implantable controller, for controlling an implantable pumping device for constricting the urinary bladder and for evacuating urine from the urinary bladder, the method comprising:
2. The method according to aspect 1, wherein the step of measuring the pressure in the first and/or second implantable hydraulic constriction element, when substantially no pressure is exerted on the urinary bladder, further comprises comparing the measured pressure with the atmospheric pressure.
3. The method according to aspect 2, wherein the step of comparing the measured pressure with the atmospheric pressure comprises measuring the atmospheric pressure using a pressure sensor connected to a signal transmitter located outside the body of the patient.
4. The method according to any one of aspects 1-3, wherein the step of increasing the pressure in the first and second implantable hydraulic constriction element to a defined level, comprises inflating the first and/or second implantable hydraulic constriction element to a defined cross-sectional distance.
5. The method according to any one of aspects 1-4, further comprising measuring the pressure in the first and/or second implantable hydraulic constriction element when the pressure in the implantable hydraulic constriction element has been increased.
6. The method according to aspect 5, wherein the steps of:
7. The method according to any one of aspects 1-6, further comprising the step of creating, in the controller, an absolute pressure by subtracting the pressure in the first and/or second implantable hydraulic constriction element, when substantially no pressure is exerted on the urinary bladder, from the pressure in the hydraulic constriction element, when the pressure in the implantable hydraulic constriction element has been increased, and wherein the step of controlling the operation device comprises controlling the operation device on the basis of the absolute pressure.
8. A controller for controlling the pressure in an implantable pumping device for constricting the urinary bladder and for evacuating urine from the urinary bladder, the controller comprising:
9. The controller according to aspect 8, wherein the computing unit is further configured to compare the measured pressure with the atmospheric pressure.
10. The controller according to aspect 9, wherein the controller is further configured to receive a pressure signal from a pressure sensor located outside of the body of the patient and compare the measured pressure with a pressure received in the pressure signal.
11. The controller according to any one of aspects 8-10, wherein the controller is configured to increase the pressure in the first and/or second implantable hydraulic constriction element on the basis of the measured pressure.
12. The controller according to aspect 11, wherein the controller is configured to increase the pressure in the first and/or second implantable hydraulic constriction element to a defined cross-sectional distance.
1. An implantable pumping device (10) for evacuating urine from the urinary bladder (U) of a patient, the implantable pumping device comprising:
2. The implantable pumping device according to aspect 1, wherein the coating comprises at least one layer of a biomaterial.
3. The implantable pumping device according to aspect 2, wherein the biomaterial comprises at least one drug or substance with antithrombotic and/or antibacterial and/or antiplatelet characteristics.
4. The implantable pumping device according to aspect 2 or 3, wherein the biomaterial is fibrin-based.
5. The implantable pumping device according to any one of the preceding aspects further comprising, a second coating (760b) arranged on the first coating.
6. The implantable pumping device according to aspect 5, wherein the second coating is a different biomaterial than said first coating.
7. The implantable pumping device according to aspect 6, wherein the first coating comprises a layer of perfluorocarbon chemically attached to the surface, and wherein the second coating comprises a liquid perfluorocarbon layer.
8. The implantable pumping device according to any one of the previous aspects, wherein the coating comprises a drug encapsulated in a porous material.
9. The implantable pumping device according to any one of the previous aspects, wherein the surface comprises a metal.
10. The implantable pumping device according to aspect 9, wherein the metal comprises at least one of the following, titanium, cobalt, nickel, copper, zinc, zirconium, molybdenum, tin or lead.
11. The implantable pumping device according to any one of the previous aspects, wherein the surface comprises a micropattern.
12. The implantable pumping device according to aspect 11, wherein the micropattern is etched into the surface prior to insertion into the body.
13. The implantable pumping device according to aspect 11-12, further comprising a layer of a biomaterial coated on the micropattern.
1. A medical device for evacuating urine from the urinary bladder of a patient and configured to be held in position by a tissue portion of a patient, the medical device comprises:
2. The medical device according to aspect 1, wherein the connecting portion comprises a flange comprising the fourth cross-sectional area, such that the flange is prevented from travelling through the hole in the tissue portion in a direction perpendicular to the first, second and third planes.
3. The medical device according to aspect 2, wherein the flange protrudes in a direction parallel to the first, second, third and fourth planes, and perpendicular to a central extension of the connecting portion.
4. The medical device according to aspect 2 or 3, wherein the flange comprises the third surface configured to engage the first tissue surface of the first side of the tissue portion.
5. The medical device according to aspect 1, wherein the connecting portion comprises at least one protruding element comprising the fourth cross-sectional area, such that the at least one protruding element is prevented from travelling through the hole in the tissue portion, such that the second portion and the connecting portion can be held in position by the tissue portion of the patient also when the first portion is disconnected from the connecting portion.
6. The medical device according to aspect 5, wherein the at least one protruding element protrudes in a direction parallel to the first, second, third and fourth planes, and perpendicular to a central extension of the connecting portion.
7. The medical device according to aspect 2 or 3, wherein the at least one protruding element comprises the third surface configured to engage the first tissue surface of the first side of the tissue portion.
8. The medical device according to any one of aspects 5-7, wherein the connecting portion comprises at least two protruding elements comprising the fourth cross-sectional area.
9. The medical device according to any one of aspects 5-8, wherein the at least two protruding elements are symmetrically arranged about a central axis of the connecting portion.
10. The medical device according to any one of aspects 5-8, wherein the at least two protruding elements are asymmetrically arranged about a central axis of the connecting portion.
11. The medical device according to any one of the preceding aspects, wherein at least one of the first, second and third surfaces comprises at least one of ribs, barbs, hooks, a friction enhancing surface treatment, and a friction enhancing material, to facilitate the implantable energized medical device being held in position by the tissue portion.
12. The medical device according to any one of the preceding aspects, wherein the connecting portion comprises a hollow portion.
13. The medical device according to aspect 8, wherein the hollow portion provides a passage between the first and second portions.
14. The medical device according to any one of the preceding aspects, wherein the first portion is detachably connected to the connecting portion by at least one of a mechanical connection and a magnetic connection.
15. The medical device according to aspect 14, wherein the first portion is detachably connected to the connecting portion by at least one of threads and corresponding grooves, a screw, a self-locking element, a twist and lock fitting, and a spring-loaded locking mechanism.
16. The medical device according to aspect 5, wherein the at least one protruding element has a height in a direction perpendicular to the fourth plane being less than a height of the first portion in said direction.
17. The medical device according to aspect 16, wherein the at least one protruding element has a height in said direction perpendicular to the fourth plane being less than half of said height of the first portion in said direction.
18. The medical device according to aspect 17, wherein the at least one protruding element has a height in said direction perpendicular to the fourth plane being less than a quarter of said height of the first portion in said direction.
19. The medical device according to aspect 18, wherein the at least one protruding element has a height in said direction perpendicular to the fourth plane being less than a tenth of said height of the first portion in said direction.
20. The medical device according to aspect 5, wherein the at least one protruding element has a diameter in the fourth plane being one of:
21. The medical device according to aspect 5, wherein the at least one protruding element has a cross-sectional area in the fourth plane being one of:
22. The medical device according to aspect 5, wherein the at least one protruding element has a height in said direction perpendicular to the fourth plane being less than half of a height of the connecting portion in said direction.
23. The medical device according to aspect 22, wherein the at least one protruding element has a height in said direction perpendicular to the fourth plane being less than a quarter of said height of the connecting portion in said direction.
24. The medical device according to aspect 23, wherein the at least one protruding element has a height in said direction perpendicular to the fourth plane being less than a tenth of said height of the connecting portion in said direction.
25. The medical device according to any one of the preceding aspects, wherein the first portion comprises a first wireless energy receiver configured to receive energy transmitted wirelessly from an external wireless energy transmitter.
26. The medical device according to any one of the preceding aspects, wherein the first portion comprises an internal wireless energy transmitter.
27. The medical device according to any one of the preceding aspects, wherein the second portion comprises a second wireless energy receiver.
28. The medical device according to any one of the preceding aspects, wherein the first portion comprises a first energy storage unit.
29. The medical device according to any one of the preceding aspects, wherein the second portion comprises a second energy storage unit.
30. The medical device according to aspect 28 or 29, wherein at least one of the first and second energy storage unit is a solid-state battery.
31. The medical device according to aspect 30, wherein the solid-state battery is a thionyl-chloride battery.
32. The medical device according to any one of aspects 24-31, wherein:
33. The medical device according to any one of the preceding aspects, wherein the first portion comprises a first controller comprising at least one processing unit.
34. The medical device according to any one of the preceding aspects, wherein the second portion comprises a second controller comprising at least one processing unit.
35. The medical device according to any one of aspects 33 and 34, wherein at least one of the first and second controller is connected to a wireless transceiver for communicating wirelessly with an external device.
36. The medical device according to any one of aspects 33-35, wherein:
37. The medical device according to aspect 36, wherein the second controller is connected to the second wireless communication receiver for receiving wireless communication from the first portion.
38. The medical device according to any one of aspects 25-38, wherein the first wireless energy receiver comprises a first coil and the internal wireless energy transmitter comprises a second coil.
39. The medical device according to any one of aspects 25-39, wherein the first portion comprises a combined coil, wherein the combined coil is configured to receive energy wirelessly from an external wireless energy transmitter, and transmit energy wirelessly to the second wireless receiver of the second portion.
40. The medical device according to aspect 38 or 39, wherein at least one of the coils are embedded in a ceramic material.
41. The medical device according to any one of the preceding aspects, further comprising a housing configured to enclose at least the first portion, and wherein a first portion of the housing is made from titanium and a second portion of the housing is made from a ceramic material.
42. The medical device according to aspect 41, wherein the portion of the housing made from a ceramic material comprises at least one coil embedded in the ceramic material.
43. The medical device according to any one of the preceding aspects, further comprising a housing configured to enclose at least the second portion, and wherein a first portion of the housing is made from titanium and a second portion of the housing is made from a ceramic material.
44. The medical device according to aspect 43, wherein the portion of the housing made from a ceramic material comprises at least one coil embedded in the ceramic material.
45. The medical device according to any one of the preceding aspects further comprising at least one sensor for providing input to at least one of the first and second controller.
46. The medical device according to aspect 45, wherein the sensor is a sensor configured to sense a physical parameter of the implantable energized medical device.
47. The medical device according to aspect 46, wherein the sensor is a sensor configured to sense at least one of:
48. The medical device according to 45-47, wherein the sensor is a sensor configured to sense a physiological parameter of the patient.
49. The medical device according to aspect 48, wherein the sensor is a sensor configured to sense at least one of:
50. The medical device according to aspect 49, wherein the sensor configured to sense a parameter related to the patient swallowing comprises at least one of:
51. The medical device according to aspect 49, wherein the sensor configured to sense pH is configured to sense the acidity in the stomach.
52. The medical device according to any one of aspects 45-51, wherein the controller is configured to transmit information based on sensor input to a device external to the body of the patient.
53. The medical device according to any one of the preceding aspects, wherein the second portion comprises at least a portion of an operation device for operating an implantable body engaging portion.
54. The medical device according to aspect 53, wherein the second portion comprises at least one electrical motor.
55. The medical device according to clam 54, wherein the second portion comprises a transmission configured to reduce the velocity and increase the force of the movement generated by the electrical motor.
56. The medical device according to clam 55, wherein the transmission is configured to transfer a week force with a high velocity into a stronger force with lower velocity.
57. The medical device according to 55 or 56, wherein the transmission is configured to transfer a rotating force into a linear force.
58. The medical device according to any one of aspects 55-57, wherein the transmission comprises a gear system.
59. The medical device according to any one of aspects 54-58, wherein the second portion comprises a magnetic coupling for transferring mechanical work from the electrical motor through one of:
60. The medical device according to any one of the preceding aspects, wherein the second portion comprises at least one hydraulic pump.
61. The medical device according to aspect 60, wherein the hydraulic pump comprises a pump comprising at least one compressible hydraulic reservoir.
62. The medical device according to any one of aspects 54-61, further comprising a capacitor connected to at least one of the first and second energy storage unit and connected to the electrical motor, wherein the capacitor is configured to:
63. The medical device according to any one of the preceding aspects, wherein at least one of the first and second portion comprises a sensation generator adapted to generate a sensation detectable by a sense of the patient.
64. The medical device according to any one of the preceding aspects, wherein the second portion comprises a force transferring element configured to mechanically transfer force from the second portion to an implanted body engaging portion.
65. The medical device according to any one of the preceding aspects, wherein the second portion comprises a force transferring element configured to hydraulically transfer force from the second portion to an implanted body engaging portion.
66. The medical device according to any one of the preceding aspects, wherein the second portion comprises at least one lead for transferring electrical energy and/or information from the second portion to an implanted body engaging portion.
67. The medical device according to any one of the preceding aspects, wherein the first portion comprises an injection port for injecting fluid into the first portion.
68. The medical device according to any one of the preceding aspects, wherein the connecting portion comprises a conduit for transferring a fluid from the first portion to the second portion.
69. The medical device according to aspect 68, wherein the conduit is arranged to extend through the hollow portion of the connecting portion.
70. The medical device according to any one of the preceding aspects, wherein the second portion comprises a first and a second chamber separated from each other, wherein the first chamber comprises a first liquid and the second chamber comprises a second liquid, and wherein the second liquid is a hydraulic liquid configured to transfer force to an implantable element configured to exert force on the body portion of the patient.
71. The medical device according to aspect 70, wherein a wall portion of the first chamber is resilient to allow an expansion of the first chamber.
72. The medical device according to any one of the preceding aspects, wherein the second portion comprises
73. The medical device according to aspect 72, wherein the first hydraulic system comprises a first hydraulic pump and the second hydraulic systems comprises a second hydraulic pump.
74. The medical device according to aspect 72 or 73, wherein each of the first and second hydraulic systems comprises a reservoir for holding hydraulic fluid.
75. The medical device according to any one of aspects 72-74, further comprising a first pressure sensor configured to sense a pressure in the first hydraulic system, and a second pressure sensor configured to sense a pressure in the second hydraulic system.
76. The medical device according to any one of the preceding aspects, wherein the first surface is configured to engage the first tissue surface of the first side of the tissue portion.
77. The medical device according to any one of the preceding aspects, wherein the first, second and third planes are parallel to a major extension plane of the tissue.
78. The medical device according to any one of the preceding aspects, wherein the fourth plane is parallel to a major extension plane of the tissue.
1. An implantable device (100) for evacuating urine from the urinary bladder (U) of a patient, the implantable device comprising:
2. The implantable device according to aspect 1, wherein the stimulation device is configured to engage and electrically stimulate muscle tissue of a wall of the bladder.
3. The implantable device according to aspect 1, wherein the stimulation device is configured to engage and electrically stimulate a portion of a sympathetic nerve connected to the bladder.
4. The implantable device according to any of the preceding aspects, wherein the signal damping device is configured to engage and electrically stimulate muscle tissue of the sphincter.
5. The implantable device according to any of aspects 1-3, wherein the signal damping device is configured to engage and electrically stimulate a portion of a sympathetic nerve connected to the sphincter to reduce the effect on the electric stimulation signal on the sphincter.
6. The implantable device according to aspect 1, wherein the stimulation device is further configured to increase an activity of a parasympathetic nerve connected to the bladder to cause muscle tissue of a wall of the bladder to relax.
7. The implantable device according to any of the preceding aspects, wherein the stimulation device is further configured to cause a second portion of the bladder to contract, wherein the second portion is arranged upstream of the first portion.
8. The implantable device according to aspect 7, wherein the stimulation device is operable to cause the second portion of the bladder to close while the first portion of the bladder contracts for evacuating urine from the bladder.
9. The implantable device according to any of the preceding aspects, wherein at least one of the first electrode arrangement and the second electrode arrangement comprises a plurality of electrode elements, each of which being configured to engage and electrically stimulate tissue of the patient.
10. The implantable device according to any of the preceding aspects, wherein at least one of the stimulation device and the signal damping device comprises a surface portion configured to be placed on the tissue, and wherein at least one of the first and second electrode element is arranged on said surface portion.
11. The implantable device according to aspect 1, wherein at least one of the stimulation device and the signal damping device comprises a cuff portion configured to be arranged at least partly around a nerve portion connected to the bladder.
12. The implantable device according to aspect 11, wherein at least one of the first and second electrode arrangements is arranged on an inner surface of the stimulation device and the signal damping device, respectively.
13. The implantable device according to any of the preceding aspects, further comprising a control unit configured to generate a pulsed electric stimulation signal delivered by the stimulation device and a pulsed electric damping signal delivered by the signal damping device.
14. The implantable device according to aspect 13, wherein the electric stimulation signal comprises a frequency of 30 Hz or less, such as 5-25 Hz, such as 10-20 Hz.
15. The implantable device according to aspect 13 or 14, wherein the electric stimulation signal comprises a pulse width of 0.01-1 ms.
16. The implantable device according to any of aspects 13-15, wherein the electric stimulation signal comprises a pulse amplitude of 1-15 mA.
17. The implantable device according to any of the preceding aspects, wherein the electric damping signal is out of phase with the electric stimulation signal.
18. The implantable device according to any of the preceding aspects, wherein the electric stimulation signal and the electric damping signal are pulsed signals, and wherein a frequency of the electric damping signal is higher than a frequency of the electric stimulation signal.
19. The implantable device according to aspect 18, wherein the frequency of the electric damping signal is at least twice the frequency of the electric stimulation signal.
20. The implantable device according to any of the preceding aspects, wherein the signal damping device is configured to deliver an electric scrambling signal for disturbing the electric stimulation signal passing the signal damping device.
21. The implantable device according to any of the preceding aspects, wherein the signal damping device further comprises a signal processing means configured to measure the electric stimulation signal received at the signal damping device and to generate the electric damping signal based on the received electric stimulation signal.
22. The implantable device according to aspect 1, further comprising a control unit operably connected to the stimulation device and the signal damping device and configured to be communicatively connected to a wireless remote control.
23. The implantable device according to aspect 22, wherein the control unit comprises an internal signal transmitter configured to receive and transmit communication signals from/to an external signal transmitter.
24. The implantable device according to aspect 22 or 23, wherein the control unit is configured to indicate a functional status of the source of energy.
25. The implantable device according to aspect 24, wherein the functional status indicates a charge level of the source of energy.
26. The implantable device according to any of aspects 22-25, wherein the control unit is configured to indicate a temperature of at least one of the source of energy, the stimulation device, the signal damping device and the tissue adjacent to the stimulation device or the signal damping device.
27. The implantable device according to any of the preceding aspects, further comprising a pressure sensor configured to generate a signal indicating a pressure in the bladder.
28. The implantable device according to any of the preceding aspects, further comprising a strain gauge configured to generate a signal indicating a strain of a wall portion of the bladder.
29. The implantable device according to aspect 27 or 28, wherein at least one of the stimulation device and the signal damping device is configured to be operated based on the signal indicating the pressure or the strain, respectively.
30. The implantable device according to any of the preceding aspects, further comprising a coating (760) arranged on at least one surface of at least one of the stimulation device, the signal damping device, and the source of energy.
31. The implantable device according to aspect 30, wherein the coating comprises at least one layer of a biomaterial.
32. The implantable device according to aspect 31, wherein the biomaterial comprises at least one drug or substance with antithrombotic and/or antibacterial and/or antiplatelet characteristics.
33. The implantable device according to aspect 31 or 32, wherein the biomaterial is fibrin-based.
34. The implantable device according to any of aspects 31-33, further comprising a second coating (760b) arranged on the first coating.
35. The implantable device according to aspect 34, wherein the second coating is a different biomaterial than said first coating.
36. The implantable device according to aspect 35. wherein the first coating comprises a layer of perfluorocarbon chemically attached to the surface, and wherein the second coating comprises a liquid perfluorocarbon layer.
37. The implantable device according to any one of aspects 31-36, wherein the coating comprises a drug encapsulated in a porous material.
38. The implantable device according to any one of aspects 31-37, wherein the surface comprises a metal.
39. The implantable device according to aspect 38, wherein the metal comprises at least one of titanium, cobalt, nickel, copper, zinc, zirconium, molybdenum, tin and lead.
40. The implantable device according to any of aspects 31-39, wherein the surface comprises a micropattern.
41. The implantable device according to aspect 40, wherein the micropattern is etched into the surface prior to insertion into the body.
42. The implantable device according to aspect 40 or 31, further comprising a layer of a biomaterial coated on the micropattern.
43. A communication system for enabling communication between a display device and an implantable device (100) according to any of the preceding aspects, the communication system comprising:
1. An implantable device for evacuating urine from the urinary bladder of a patient, the implantable device comprising:
2. The implantable device according to aspect 1, wherein the first stimulation device is configured to engage and electrically stimulate muscle tissue of a wall of the bladder.
3. The implantable device according to aspect 1, wherein the first stimulation device is configured to engage and electrically stimulate a portion of a sympathetic nerve connected to the bladder.
4. The implantable device according to any of the preceding aspects, wherein the second stimulation device is configured to engage and electrically overstimulate muscle tissue of the sphincter to cause the sphincter to relax.
5. The implantable device according to any of aspects 1-3, wherein the second stimulation device is configured to engage and electrically stimulate a portion of a parasympathetic nerve connected to the sphincter to cause the sphincter to relax.
6. The implantable device according to aspect 1, wherein the first stimulation device is further configured to increase an activity of a parasympathetic nerve connected to the bladder to cause muscle tissue of a wall of the bladder to relax.
7. The implantable device according to any of the preceding aspects, wherein the first stimulation device is further configured to cause a second portion of the bladder to contract, wherein the second portion is arranged upstream of the first portion.
8. The implantable device according to aspect 7, wherein the first stimulation device is operable to cause the second portion of the bladder to close while the fist portion of the bladder contracts for evacuating urine from the bladder.
9. The implantable device according to any of the preceding aspects, wherein at least one of the first electrode arrangement and the second electrode arrangement comprises a plurality of electrode elements, each of which being configured to engage and electrically stimulate tissue of the patient.
10. The implantable device according to any of the preceding aspects, wherein at least one of the first and the second stimulation device comprises a surface portion configured to be placed on the tissue, and wherein at least one of the first and second electrode element is arranged on said surface portion.
11. The implantable device according to aspect 1, wherein at least one of the first and second stimulation device comprises a cuff portion configured to be arranged at least partly around a nerve portion connected to the bladder.
12. The implantable device according to aspect 11, wherein at least one of the first and second electrode arrangements is arranged on an inner surface of the first and second stimulation device, respectively.
13. The implantable device according to any of the preceding aspects, further comprising a control unit configured to operate at least one of the first and second stimulation device to generate a pulsed first and second electric stimulation signal, respectively.
14. The implantable device according to aspect 13, wherein at least one of the first and second electric stimulation signals comprises a frequency of 30 Hz or less, such as 5-25 Hz, such as 10-20 Hz.
15. The implantable device according to aspect 13 or 14, wherein at least one of the first and second electric stimulation signals comprises a pulse width of 0.01-1 ms.
16. The implantable device according to any of aspects 13-15, wherein at least one of the first and second electric stimulation signals comprises a pulse amplitude of 1-15 mA.
17. The implantable device according to any of the preceding aspects, wherein the first electric stimulation signal and the second electric stimulation signal are pulsed signals, and wherein at least one of a frequency, pulse width and pulse amplitude of the second electric stimulation signal is higher than a corresponding parameter of the first electric stimulation signal.
18. The implantable device according to aspect 17, wherein the frequency or pulse amplitude of the second electric stimulation signal is at least twice the corresponding frequency or pulse amplitude of the first electric stimulation signal.
19. The implantable device according to aspect 1, further comprising a control unit operably connected to the first stimulation device and the second stimulation device and configured to be communicatively connected to a wireless remote control.
20. The implantable device according to aspect 19, wherein the control unit comprises an internal signal transmitter configured to receive and transmit communication signals from/to an external signal transmitter.
21. The implantable device according to aspect 19 or 20, wherein the control unit is configured to indicate a functional status of the source of energy.
22. The implantable device according to aspect 21, wherein the functional status indicates a charge level of the source of energy.
23. The implantable device according to any of aspects 19-22, wherein the control unit is configured to indicate a temperature of at least one of the source of energy, the first stimulation device, the second stimulation device, the first portion of the bladder, and the sphincter.
24. The implantable device according to any of the preceding aspects, further comprising a pressure sensor configured to generate a signal indicating a pressure in the bladder.
25. The implantable device according to any of the preceding aspects, further comprising a strain gauge configured to generate a signal indicating a strain of a wall portion of the bladder.
26. The implantable device according to aspect 24 or 25, wherein at least one of the first stimulation device and the second stimulation device is configured to be operated based on the signal indicating the pressure or the strain, respectively.
27. The implantable device according to any of the preceding aspects, further comprising a coating (760) arranged on at least one surface of at least one of the stimulation device, the signal damping device, and the source of energy.
28. The implantable device according to aspect 27, wherein the coating comprises at least one layer of a biomaterial.
29. The implantable device according to aspect 28, wherein the biomaterial comprises at least one drug or substance with antithrombotic and/or antibacterial and/or antiplatelet characteristics.
30. The implantable device according to aspect 28 or 29, wherein the biomaterial is fibrin-based.
31. The implantable device according to any of aspects 28-30, further comprising a second coating (760b) arranged on the first coating.
32. The implantable device according to aspect 31, wherein the second coating is a different biomaterial than said first coating.
33. The implantable device according to aspect 32. wherein the first coating comprises a layer of perfluorocarbon chemically attached to the surface, and wherein the second coating comprises a liquid perfluorocarbon layer.
34. The implantable device according to any one of aspects 28-33, wherein the coating comprises a drug encapsulated in a porous material.
35. The implantable device according to any one of aspects 28-34, wherein the surface comprises a metal.
36. The implantable device according to aspect 35, wherein the metal comprises at least one of titanium, cobalt, nickel, copper, zinc, zirconium, molybdenum, tin and lead.
37. The implantable device according to any of aspects 28-36, wherein the surface comprises a micropattern.
38. The implantable device according to aspect 37, wherein the micropattern is etched into the surface prior to insertion into the body.
39. The implantable device according to aspect 37 or 38, further comprising a layer of a biomaterial coated on the micropattern.
40. A communication system for enabling communication between a display device and an implantable device (100) according to any of the preceding aspects, the communication system comprising:
1. A method of implanting a powered medical device, the method comprising:
2. The method according to aspect 1, wherein the transferring member is configured to transfer mechanical force from the second portion to the body engaging portion.
3. The method according to aspect 1, wherein the transferring member is configured to transfer hydraulic force from the second portion to the body engaging portion.
4. The method according to any one of aspects 1-3, wherein the transferring member is configured to transfer electrical energy force from the second portion to the body engaging portion.
5. The method according to any one of the preceding aspects, wherein the transferring member is configured to transfer data between the second portion and the body engaging portion.
6. The method according to any one of the preceding aspects, wherein the step of placing the transferring member comprises placing the transferring member at least partially between the peritoneum and the layer of muscular tissue of the abdominal wall, such that at least ½ of the length of the transferring member is placed on the outside of the peritoneum of the patient.
7. The method according to any one of the preceding aspects, wherein the step of placing the transferring member comprises placing the transferring member at least partially between the peritoneum and the layer of muscular tissue of the abdominal wall, such that at least ⅔ of the length of the transferring member is placed on the outside of the peritoneum of the patient.
8. The method according to any one of the preceding aspects, wherein the step of placing the transferring member comprises placing the transferring member entirely outside of the peritoneum of the patient.
9. The method according to any one of the preceding aspects, wherein the step of placing the transferring member comprises placing the transferring member such that it extends from the second portion to an area between the rib cage and the peritoneum of the patient, outside of the peritoneum.
10. The method according to any one of aspects 1-9, wherein the step of placing the transferring member comprises placing the transferring member such that it extends from the second portion to the subperitoneal space, outside of the peritoneum.
11. The method according to aspect 10, wherein the step of placing the transferring member comprises placing the transferring member such that it extends from the second portion to the urinary bladder, outside of the peritoneum.
12. The method according to aspect 10, wherein the step of placing the transferring member comprises placing the transferring member such that it extends from the second portion to the urethra, outside of the peritoneum.
13. The method according to any one of the preceding aspects, wherein the step of placing the second portion of the implantable energized medical device between the peritoneum and the layer of muscular tissue of the abdominal wall comprises placing the second portion between a first and second layer of muscular tissue of the abdominal wall.
14. The method according to any one of the preceding aspects, wherein the step of placing the second portion comprises placing a second portion comprising an electrical motor.
15. The method according to any one of the preceding aspects, wherein the step of placing the second portion comprises placing a second portion comprising a hydraulic pump.
16. The method according to any one of the preceding aspects, wherein the step of placing the second portion comprises placing a second portion comprising an energy storage unit.
17. The method according to any one of the preceding aspects, wherein the step of placing the second portion comprises placing a second portion comprising a receiver for receiving at least one of: energy and communication, wirelessly.
18. The method according to any one of the preceding aspects, wherein the step of placing the first portion comprises placing a first portion comprising a transmitter for transmitting at least one of: energy and communication, wirelessly.
19. The method according to any one of the preceding aspects, wherein the step of placing the second portion comprises placing a second portion comprising a controller involved in the control of the powered medical device.
20. The method according to any one of the preceding aspects, wherein the second portion is elongated and has a length axis extending substantially in the direction of the elongation of the second portion, and wherein the step of placing the second portion comprises placing the second portion such that the length axis is substantially parallel with the cranial-caudal axis of the patient.
21. The method according to any one of aspects 1-20, wherein the second portion is elongated and has a length axis extending substantially in the direction of the elongation of the second portion, and wherein the step of placing the second portion comprises placing the second portion such that the length axis is substantially perpendicular with the cranial-caudal axis of the patient.
22. The method according to any one of the preceding aspects, wherein the second portion is elongated and has a length axis extending substantially in the direction of the elongation of the second portion, and wherein the step of placing the second portion comprises entering a hole in a layer of muscular tissue of the stomach wall in the direction of the length axis of the second portion and pivoting or angling the second portion after the hole has been entered.
23. The method according to any one of the preceding aspects, wherein the step of placing the first portion of the implantable energized medical device between the skin of the patient and a layer of muscular tissue of the abdominal wall comprises placing the first portion in the subcutaneous tissue.
24. The method according to any one of aspects 1-22, wherein the step of placing the first portion of the implantable energized medical device between the skin of the patient and a layer of muscular tissue of the abdominal wall comprises placing the first portion between a first and second layer of muscular tissue of the abdominal wall.
25. The method according to any one of the preceding aspects, wherein the step of placing the first portion comprises placing a first portion comprising an energy storage unit.
26. The method according to any one of the preceding aspects, wherein the step of placing the first portion comprises placing a first portion comprising a receiver for receiving at least one of: energy and communication, wirelessly.
27. The method according to any one of the preceding aspects, wherein the step of placing the first portion comprises placing a first portion comprising a transmitter for transmitting at least one of: energy and communication, wirelessly.
28. The method according to any one of the preceding aspects, wherein the step of placing the first portion comprises placing a first portion comprising a controller involved in the control of the powered medical device.
29. The method according to any one of the preceding aspects, wherein the first portion is elongated and has a length axis extending substantially in the direction of the elongation of the first portion, and wherein the step of placing the first portion comprises placing the first portion such that the length axis is substantially parallel with the cranial-caudal axis of the patient.
30. The method according to any one of the preceding aspects, wherein the first portion is elongated and has a length axis extending substantially in the direction of the elongation of the first portion, and wherein the step of placing the first portion comprises placing the first portion such that the length axis is substantially perpendicular with the cranial-caudal axis of the patient.
31. The method according to any one of the preceding aspects, wherein the first portion is elongated and has a first portion length axis extending substantially in the direction of the elongation of the first portion, and the second portion is elongated and has a second portion length axis extending substantially in the direction of the elongation of the second portion, and wherein the step of placing the first and second portions comprises placing the first and second portions such that the first portion length axis and the second portion length axis are placed at an angle in relation to each other exceeding 30°.
32. The method according to aspect 31, wherein the step of placing the first and second portions comprises placing the first and second portions such that the first portion length axis and the second portion length axis are placed at an angle in relation to each other exceeding 45°.
33. The method according to any one of the preceding aspects, further comprising the step of placing the connecting portion through at least one layer of muscular tissue of the abdominal wall.
34. The method according to any one of the preceding aspects, wherein the first portion, the second portion and the connecting portion are portions of a single unit.
35. The method according to any one of aspects 1-33, further comprising the step of connecting the first portion to the connecting portion, in situ.
36. The method according to any one of aspects 1-33, further comprising the step of connecting the second portion to the connecting portion, in situ.
37. The method according to any one of the preceding aspects, further comprising the step of connecting the transferring member to the first portion.
36. The method according to any one of the preceding aspects, further comprising the step of connecting the transferring member to the body engaging portion.
37. The method according to any one of the preceding aspects, wherein the body engaging portion comprises a medical device for stretching the stomach wall such that a sensation of satiety is created.
38. The method according to any one of aspects 1-36, wherein the body engaging portion comprises a constriction device configured to constrict a luminary organ of a patient.
39. The implantable device according to aspect 38, wherein the body engaging portion comprises an implantable constriction device.
40. The implantable device according to aspect 39, wherein the implantable constriction device comprises an implantable constriction device for constricting a luminary organ of the patient.
41. The implantable device according to aspect 38, wherein the body engaging portion comprises an implantable element for actively emptying the urinary bladder of the patient.
42. The implantable device according to aspect 38, wherein the implantable element for actively emptying the urinary bladder of the patient is configured to empty the bladder of the patient by compressing the urinary bladder from the outside thereof.
43. The implantable device according to any one of aspects 1-36, wherein the body engaging comprises an element for electrically stimulating a tissue portion of a patient.
1. A system for controlling a medical implant implanted in a patient, comprising:
2. The system according to embodiment 1, wherein:
3. The system according to any one of the preceding embodiments, wherein:
4. The system according to any one of the preceding embodiments, wherein:
5. The system according to any one the preceding embodiments, wherein:
6. The system according to any one of the preceding embodiments, wherein:
7. The system according to any one of the preceding embodiments, wherein:
8. The system according to embodiment 7, wherein:
9. The system according to embodiment 7 or embodiment 8, wherein:
10. The system according to embodiment 9, wherein:
11. The system according to embodiment 10, wherein:
12. The system according to any of embodiments 3 to 11, wherein:
13. The system according to embodiment 12, wherein:
14. The system according to any of embodiments 3 to 14, wherein:
15. The system according to embodiment 14 wherein
16. The system according to any of embodiments 3 to 15, wherein
17. The system according to any of embodiments 13 to 16, wherein
18. The system according to any one of the preceding embodiments, wherein:
19. The system according to embodiment 18, wherein
20. The system according to embodiment 18 or embodiment 19, further comprising:
1. An apparatus for powering an implant for a human patient, comprising:
2. The apparatus according to embodiment 1, wherein the discharging from the implantable energy source during startup of the energy consuming part is slower than the energy needed for startup of the energy consuming part.
3. The apparatus according to embodiment 1,
4. The apparatus according to any preceding embodiment, wherein the implantable energy source is a re-chargeable battery.
5. The apparatus according to any preceding embodiment, wherein the implantable energy source is a solid-state battery.
6. The apparatus according to embodiment 5, wherein the battery is a trionychoid battery.
7. The apparatus according to any preceding embodiment, wherein the implantable energy source is connected to the energy consuming part and configured to power the energy consuming part after it has been started using the energy provider.
8. The apparatus according any preceding embodiment, wherein the energy provider is a capacitor.
9. The apparatus according to any preceding embodiment, wherein the energy provider is a start capacitor.
10. The apparatus according to any preceding embodiment, wherein the energy provider is a run capacitor.
11. The apparatus according to any preceding embodiment, wherein the energy provider is a dual run capacitor.
12. The apparatus according to any preceding embodiment, further comprising a second energy provider configured to be charged by the implantable energy source and to provide the energy consuming part with electrical power.
13. The apparatus according to any preceding embodiment, wherein the energy provider is a supercapacitor.
14. The apparatus according to any preceding embodiment, wherein the energy consuming part is a motor for operating a device or function of the implant.
15. The apparatus according to any preceding embodiment, wherein the energy consuming part is at least one of:
16. The apparatus according to any preceding embodiment, wherein the energy consuming part is motor for powering a hydraulic pump.
17. The apparatus according to any preceding embodiment, wherein the energy consuming part is a feedback unit.
18. The apparatus according to embodiment 17, wherein the feedback unit is a vibrator.
19. The apparatus according to any preceding embodiment, wherein the energy consuming part is configured to operate a valve comprised in the implant.
20. The apparatus according to any preceding embodiment, wherein the energy consuming part is a control unit for controlling at least a part of the implant.
Aspect 309B eHealth Broadcasting Data
1. An implant comprising:
2. The implant according to embodiment 1, wherein the communication unit is configured to broadcast the information using a short to mid-range transmitting protocol.
3. The implant according to any preceding embodiment, wherein the information is broadcasted using at least one of:
4. The implant according to any preceding embodiment, wherein the implant further comprises a control unit connected to the sensor and to the communication unit, wherein the control unit is configured to anonymize the information.
5. The implant according to any of embodiments 1-3, wherein the implant further comprises a control unit connected to the sensor and to the communication unit, wherein the control unit is configured to encrypt the information.
6. The implant according to any preceding embodiment, wherein the communication unit further is configured to broadcast the information periodically.
7. The implant according to any preceding embodiment, further comprising a control unit configured to cause the communication unit to broadcast the information in response to a second parameter being above a predetermined threshold.
8. The implant according to any of the preceding embodiments, wherein the sensed parameter is at least one of a temperature, a pulse, a glucose level, an activity of an organ, or an acceleration.
9. The implant according to any of the preceding embodiments, further comprising an implantable energy source and an energy source indicator, wherein the energy source indicator is configured to indicate a functional status of the implantable energy source.
10. The implant according to embodiment 9, wherein the functional status indicates at least one of charge level and temperature of the implantable energy source.
11. The implant according to any preceding embodiment, wherein the functional parameter is a parameter relating to the internal control unit.
12. A system comprising the implant according to any preceding embodiment, and an external device comprising a receiver for receiving data from the implant and a transmitter for transmitting data, wherein the external device is configured to receive the broadcasted information, encrypt the received information using a key and transmit the encrypted received information.
13. The system according to embodiment 12, when implanted in a patient, wherein the internal device is configured to transmit the data using the body of the patient as a conductor, and the external device is configured to receive the data via the body.
14. The system according to embodiment 12, wherein the communication unit of the implant is configured to transmit the data wirelessly to the external device.
Aspect 310B eHealth Double Encryption
1. A system comprising:
2. The system according to embodiment 1, wherein the encryption unit is configured to encrypt the data to be transmitted using a second key.
3. The system according to any of embodiments 1 or 2, wherein the first key or the second key is implant specific information, a secret key associated with the external device, an identifier of the implant or an identifier of the communication unit.
4. The system according to any of the preceding embodiments, wherein the second key is a key transmitted by the external device to the internal device.
5. The system according to any of embodiments 1-3, wherein the second key is a combined key comprising a third key received by the implant form the external device.
6. The system according to any preceding embodiment, wherein the first key is a combined key comprising a fourth key, wherein the fourth key is received by the external device from a verification unit connected to or comprised in the external device.
7. The system according to any preceding embodiment, wherein the verification unit is configured to receive authentication input from a user, for authenticating the communication between the implant and the external device.
8. The system according to embodiment 7, wherein the authentication input is a code.
9. The system according to embodiment 7, wherein the authentication input is based on a biometric technique selected from the list of: a fingerprint, a palm vein structure, image recognition, face recognition, iris recognition, a retinal scan, a hand geometry, and genome comparison.
10. The system according to embodiment 9, wherein the verification unit is configured to receive a fingerprint from a fingerprint reader.
11. The system according to any preceding embodiment, wherein the information is broadcasted using a short to mid-range transmitting protocol.
12. The system according to any preceding embodiment, wherein the information is transmitted using at least one of:
13. The system according to any preceding embodiment, wherein the internal device comprises a first conductive member and the external device comprises a second conductive member, wherein the first and the second conductive members are configured to transmit the data using the body as a conductor.
14. The system according to any preceding embodiment, wherein the communication unit is configured to encrypt the data before transmitting the data.
15. The system according to embodiment 6 wherein the external device is configured to decrypt the received data and encrypt it before transmitting the data to the third device.
16. The system according to any preceding embodiment, wherein the external device is configured to transmit a request for data to the communication unit, and the communication unit is configured to in response to a request for data transmit the data to the external device.
17. The system according to any preceding embodiment, wherein the communication unit further is configured to broadcast the information periodically.
18. The system according to any preceding embodiment, further comprising an internal control unit configured to cause the communication unit to broadcast the information in response to a second parameter being above a predetermined threshold.
1. A system for communication instructions, the system comprising:
2. The system according to embodiment 1, wherein the internal controller is configured to verify the integrity of the first set of instructions using a cyclic redundancy check.
3. The system according to embodiment 1-2, wherein the cryptographic hash or metadata comprises a cryptographic hash, and wherein the internal controller is configured to verifying the integrity of the first set of instructions by:
4. The system according to embodiment 3, wherein the cryptographic hash algorithm comprises one of:
5. The system according to any of embodiments 3-4, wherein the cryptographic hash is a signature obtained by using a private key of the implant, and wherein the internal controller is configured to verifying the first set of instructions by the signature using a public key corresponding to the private key.
6. The system according to any of embodiments 3-5, wherein the cryptographic hash or metadata comprises a metadata, and wherein the internal controller is configured to verifying the integrity of the data by:
7. The system according to embodiment 6, wherein the metadata comprises: a length of the data and or a timestamp.
8. The system according to any of the preceding embodiments, wherein the external device is separate from the second external device.
9. The system according to any of the preceding embodiments, wherein the internal controller is configured to communicate with the second external device using a different protocol than a protocol used for communication with the external device.
10. The system according to any of the preceding embodiments, wherein the internal communication unit comprises a wireless transceiver for communication with the external device, and a conductive member for communicating with the second external device, wherein the second external device comprises a second conductive member.
11. The system according to embodiment 10, wherein the communication between the internal communication unit and the second external device is performed using the patient's body as a conductor.
12. The system according to any of embodiments 1-11, wherein the internal controller is configured to transmit information relating to the received first set of instructions to the external device, and the external device is configured to confirm that the information relates to the first set of instructions transmitted by the external device.
13. The system according to any of embodiments 1-12, wherein the internal controller is configured to:
14. The system according to any of embodiments 1-13, wherein the external device is configured to transmit the first set of instructions, and wherein the first set of instructions comprises a cryptographic hash corresponding to a previous set of instructions.
15. The system according to any of embodiments 1-14, wherein
16. The system according to embodiment 15, wherein the first and second parameters relate to a pulse of the patient, a respiration rate of the patient, a temperature of the patient, a sound of the patient, or a physical movement of the patient.
17. The system according to any of embodiments 15-16, wherein the measured parameter by the external device is provided with a timestamp, and the measured parameter measured by the implant is provided with a timestamp, wherein the comparison of the parameter measured at the implant to the parameter measured by the external device comprises comparing the timestamp of the measured parameter received from the implant to the timestamp of the measured parameter by the external device.
Aspect 312B eHealth Programming Predefined Steps
1. An implant comprising:
2. The implant according to any preceding embodiment, wherein the predefined program steps comprise setting a variable related to a pressure, a time, a minimum or maximum temperature, a current, a voltage, an intensity, a frequency, an amplitude of electrical stimulation, a feedback, a post-operative mode or a normal mode, a catheter mode, a fibrotic tissue mode, an time open after urination, a time open after urination before bed-time.
3. The implant according to any preceding embodiment, wherein the verification function is configured to reject the update in response to the update comprising program steps not comprised in the set of predefined program steps.
4. The implant according to any preceding embodiment, wherein the verification function is configured to allow the update in response to the update only comprising program steps comprised in the set of predefined program steps.
5. The implant according to embodiment 1, wherein the internal communication unit is configured to communicate with the external device via a first wireless connection for receiving the update to the second control program, and a second connection for performing an authentication of the communication with the external device.
6. The implant according to embodiment 5, wherein the second connection is a wireless short-range connection.
7. The implant according to embodiment 5 or 6, wherein the authentication second connection is an electrical connection using the patient's body as a conductor
8. The implant according to any preceding embodiment, wherein the internal computing unit is further configured to, upon verification, installing the update.
9. The implant according to any preceding embodiment, wherein the internal computing unit has a sleep mode and an active mode, and the implant further comprises a sensor configured to detect a wake signal, and wherein the implant is configured to in response to a detected wake signal set the internal computing unit to the active mode.
10. The implant according to embodiment 9, wherein sensor is configured to detect an acoustic signal as wake signal or wherein the sensor is configured to detect a magnetic signal as the wake signal
11. The implant according to any of embodiments 9-10, wherein
12. The implant according to any of embodiments 9-11, further comprising a second internal computing unit, and wherein the implant is configured to set the internal computing unit to the active mode via the second internal computing unit.
13. The implant according to any of embodiments 9-12, wherein the internal computing unit in the sleep mode is substantially without power, and wherein setting the internal computing unit in the active mode comprises providing the internal computing unit with power.
14. The implant according to embodiment 13, wherein the implant comprises an energy controller for controlling the power supplied to the internal computing unit.
15. The implant according to embodiment 14, wherein the sensor is configured to provide the energy controller with a second wake signal in response to detecting the wake signal, and wherein the energy controller is configured to set the computing unit in the active mode in response to the second wake signal.
16. The implant according to any preceding embodiment, wherein
17. The implant according to any preceding embodiment, wherein
18. The implant according to any preceding embodiment, wherein the sensor is a hall effect sensor, a fluxgate sensor, an ultra-sensitive magnetic field sensor or a magneto-resistive sensor.
19. The implant according to any preceding embodiment, wherein the sensor comprises a third coil having an iron core.
20. The implant according to any preceding embodiment, wherein the sensor is comprised in the internal communication unit.
Aspect 313B eHealth Watchdog
1. A system comprising an implant comprising:
2. The system according to any preceding embodiment, wherein the first control program comprises a second reset function for resetting the timer of the first reset function.
3. The system according to embodiment 2, wherein the first reset function comprises a timer and the second reset function is configured to reset the timer.
4. The system according to any preceding embodiment, wherein the reset function comprises a first reset function and a second reset function, wherein the first reset function is configured to trigger a corrective function for correcting the first control program, and wherein the second reset function is configured to restart the first control program after the corrective function has been triggered.
5. The system according to any preceding embodiment, wherein the first or second reset function is configured to invoke a hardware reset by activating an internal or external pulse generator which is configured to create a reset pulse for the internal computing unit or the first control program.
6. The system according to any preceding embodiment, wherein the internal computing unit is configured to have an active mode and a sleep mode, and wherein the first reset function is configured to have an active mode and a sleep mode corresponding to the active mode and the sleep mode of the internal computing unit.
7. The system according to any preceding embodiment, further comprising a sensor for measuring a physiological parameter of the patient or a parameter of the implant, and wherein the sensor is configured to invoke the reset function in response to the parameter being above or below a predetermined value.
8. The system according to embodiment 7, wherein the sensor is a pressure sensor adapted to measure a pressure in a part of the implant.
9. The system according to embodiment 8, wherein the pressure sensor is configured to measure a pressure in a reservoir or a restriction device of the implant.
10. The system according to embodiment 7, wherein the sensor is a pressure sensor adapted to measure a pressure in an organ of the patient's body.
11. The system according to any preceding embodiment, wherein the reset function is configured to be invoked by an electrical reset pulse, and wherein the sensor is adapted to invoke the reset function by activating an internal or external pulse generator which is configured to create a reset pulse for the reset function.
12. The system according to any of embodiments 7-11, wherein the physiological parameter of the patient or a parameter of the implant is a temperature.
13. The system according to any preceding embodiment, wherein the reset function comprises invoking a second control program comprising a safety measure.
14. The system according to embodiment 13, wherein the safety measure comprises controlling a function of the implant.
15. The system according to any preceding embodiment, wherein the internal computing unit is configured to invoke the reset function periodically.
16. The system according to embodiment 15, wherein periodically comprises every 24 hours.
17. The system according to any preceding embodiment, wherein the internal computing unit further comprises a monitoring function for monitoring a function of the implant or the first control program, and wherein the reset function is configured to in response to an incorrect or absent response for the monitoring program, reset or restart the first control program.
18. The system according to any preceding embodiment,
19. The system according to embodiment 18,
20. The system according to embodiment 19, wherein the sensor is configured to measure the physical parameter periodically.
Aspect 314B eHealth Logging
1. A system comprising an implant adapted for communication with a first external device and a second external device, when the implant is adapted to be implanted in a patient, the implant comprising:
2. The system according to embodiment 1, wherein the update or configuration comprises a set of instructions for the control program.
3. The system according to embodiment 1, wherein the steps comprise a subset of a set of predefined steps.
4. The system according to any one of embodiments 1-3, wherein the second external device is configured to confirm that the update or configuration is correct based on the received logging data.
5. The system according to any one of embodiments 1-4, wherein the logging data is related to the receipt of the update or configuration, and the internal computing unit is configured to install the update or configuration in response to receipt of a confirmation that the logging data relates to a correct set of instructions.
6. The system according to any one of embodiments 1-5, wherein the logging data is related to the installation of the update or configuration, and wherein the internal computing unit is configured to activate the installation in response to a confirmation that the update or configuration is correct.
7. The system according to any one of embodiments 1-6, wherein the update or configuration comprises a plurality of steps, and the update or configuration is received by the internal computing unit in two or more sub steps.
8. The system according to any one of embodiments 1-7, further comprising a sensation generator adapted to create a sensation detectable by the user.
9. The system according to any one of embodiments 1-8, wherein the internal computing unit is configured to cause the sensation generator to create a sensation detectable by the user in response to the update or configuration being received, in response to the update or configuration being installer or in response to the update or configuration being confirmed.
10. The system according to any one of embodiments 1-9, wherein the sensation generator is a vibrator or a speaker.
11. The system according to embodiment 1, wherein the configuration or update comprises a value for a predetermined parameter.
12. The system according to embodiment 1, wherein the configuration or update comprises a step from a set of predetermined steps.
13. The system according to any one of embodiments 1-11, wherein communication over the first communication channel is performed using a first network protocol, and communication over the second communication channel is performed using a second network protocol, the first and second protocols being different.
14. The system according to any one of embodiments 1-13, wherein the network protocol is one from the list of:
15. The system according to any one of embodiments 1-14, wherein the second network protocol is one from the list of:
16. The system according to any one of embodiments 1-15, wherein the second communication channel is an electrical connection.
Aspect 315B eHealth Sleeping Internal Control Unit
1. A system comprising an implant for implanting in a patient, comprising:
2. The system according to embodiment 1, wherein:
3. The system according to embodiment 1 or 2, wherein the sensor is a mechanical sensor.
4. The system according to embodiment 3, wherein the sensor comprises a pressure sensor, a piezoelectric sensor, or a bimetal.
5. The system according to any preceding embodiment, wherein:
6. The system according to embodiment 5, wherein:
7. The system according to any preceding embodiment, wherein:
8. The system according to any preceding embodiment, wherein the sensor is an analog sensor or a digital sensor.
9. The system according to any preceding embodiment, further comprising a sensation generator configured to, upon request, generate a sensation detectable by a sense of the patient.
10. The system according to embodiment 9, wherein the sensation generator is configured to receive the request from the controller of the implant.
11. The system according to embodiment 10, wherein the request is generated by the controller in response to the sensor measurement having the value outside of the predetermined interval.
12. The system according to any of embodiments 9 to 11, wherein the sensation generator is configured to receive the request from an external controller.
13. The system according to any of embodiments 9 to 12, wherein the generated sensation comprises a plurality of sensation components.
14. The system according to any of embodiments 9 to 13, wherein the sensation generator is configured to create the sensation or sensation components by at least one of:
15. The system according to any preceding embodiment, further comprising an active unit, communicatively coupled to the processor, for performing controlling or monitoring a bodily function in the patient.
16. The system according to embodiment 15, wherein:
17. The system according to any preceding embodiment, wherein:
18. The system according to embodiment 17, further comprising:
19. The system according to embodiment 18, wherein:
1. A system for transmitting an instruction from a first external device to an implant, comprising:
2. The system according to embodiment 1, wherein the second external device is configured to transmit the encrypted instruction by transmitting the encrypted instruction to the first external device, and wherein the first external device is configured to transmit the encrypted instruction to the implant.
3. The system according to embodiment 1, wherein the second external device is configured to transmit the encrypted instruction by transmitting the encrypted instruction to a third external device, and wherein the third external device is configured to transmit the encrypted instruction to the implant.
4. The system according to any of embodiments 1-3, wherein the second external device is an encryption device communicatively coupled to the first external device, and wherein any communication between the implant and the second external device is relayed through the first external device.
5. The system according to any one of embodiments 1-4, wherein the internal control unit is configured to run the decrypted instruction for controlling a function of the implant.
6. The system according to any one of embodiments 1-5, wherein the first external device is configured to display a user interface for receiving the instruction.
7. The system according to any one of embodiments 1-6, wherein the implant comprises a set of a predefined program steps, and wherein the implant is configured to verify that the received instruction is comprised in the predefined program steps.
8. The system according to embodiment 7, wherein the implant is configured to reject the instruction in response to the instruction not being comprised in the set of predefined program steps.
9. The system according to any of embodiments 7-8, wherein the implant is configured to allow the instruction in response to the instruction being comprised in the set of predefined program steps.
10. The system according to any of embodiments 1-9, wherein the first external device and the implant are configured to communicate over a wireless connection.
1. A system comprising an implantable controller for controlling an energized implant, when implanted in a patient, the controller comprises:
2. The system according to embodiment 1, wherein the implantable controller further comprises at least one implantable housing for sealing against fluid, and wherein the computing unit and the microphone are placed inside of the housing.
3. The system according to any one of embodiments 1-2, wherein the computing unit is configured to derive a pulse of the patient from the registered sound related to a bodily function.
4. The system according to any one of embodiments 1-3, wherein the computing unit is configured to derive information related to the patient urinating from the registered sound related to a bodily function.
5. The system according to any one of embodiments 1-4, wherein the computing unit is configured to derive information related to a bowel activity of the patient from the registered sound related to a bodily function.
6. The system according to any one of embodiments 1-5, wherein the computing unit is configured to derive information related to a functional status of the implant from the registered sound related to a function of the implant.
7. The system according to embodiment 6, wherein the computing unit is configured to derive information related to the functional status of an operation device of the implant, from the registered sound related to a function of the implant.
8. The system according to embodiment 7, wherein the computing unit is configured to derive information related to the functional status of at least one of: a motor, a pump and a transmission of the operation device of the implant from, the registered sound related to a function of the implant.
9. The system according to any one of the preceding embodiments, further comprising a transceiver, and wherein the controller is configured to transmit a parameter derived from the sound registered by the at least one microphone using the transceiver.
1. An implantable urine evacuating device (10) for evacuating urine from the urinary bladder (U) of a patient, the implantable urine evacuating device comprising:
2. The implantable pumping device according to aspect 1, wherein the first constriction device is sized and formed to house a first portion of the urinary bladder, and
3. The implantable urine evacuating device according to any one of aspects 1 and 2, wherein the controller is configured to receive a pressure signal from a pressure sensor 106 configured to measure the pressure in or exerted by at least one of the first and second constriction devices.
4. The implantable urine evacuating device according to any one of aspects 1-3, wherein at least one of the first and second constriction device is a hydraulic constriction device.
5. The implantable urine evacuating device according to any one of aspects 1-3, wherein at least one of the first and second constriction device is a mechanical constriction device.
6. The implantable urine evacuating device according to any one of aspects 1-5, wherein at least one of the first and second constriction device is a constriction device configured to constrict by electrically stimulating at least one tissue wall of the urinary bladder.
7. The implantable urine evacuating device according to any one of the preceding aspects, wherein the second constriction device is configured to constrict the second portion of the urinary bladder using electrical stimulation, and wherein the implantable urine evacuating device further comprises a cancellation unit configured to be placed downstream the second portion, the cancellation unit being configured to cancel the electrical stimulation such that the urinary sphincter remains substantially unaffected by the electrical stimulation.
8. The implantable urine evacuating device according to any one of the preceding aspects, wherein:
9. The implantable urine evacuating device according to any one of the preceding aspects, wherein at least one of the first and second constriction device comprises at least one constriction element configured to contact a first portion of the urinary bladder and at least one abutment configured to contact a second portion of the urinary bladder and for withholding the force from the at least one constriction element, such that the urinary bladder is constricted between the at least one constriction element and the abutment.
10. The implantable urine evacuating device according to any one of aspects 1-8, wherein at least one of the first and second constriction device comprises at least a first and a second constriction element, wherein the first constriction element is configured to contact a first portion of the urinary bladder and the second constriction element is configured to contact a second portion of the urinary bladder, such that the urinary bladder is constricted between the first and second constriction elements.
11. The implantable urine evacuating device according to any one of aspects 9 and 10, further comprising a support element (24), and wherein at least one of the at least one constriction element and the at least one abutment is connected to the support element.
12. The implantable urine evacuating device according to aspect 11, wherein the support element is configured to form at least a portion of a surrounding structure (20) configured to surround the urinary bladder.
13. The implantable urine evacuating device according to aspect 11, wherein the support element comprises at least one fluid conduit (109) at least partially integrated in the support element.
14. The implantable urine evacuating device according to any one of aspects 12-13, wherein the support element comprises a connection portion for connecting the support element to another support element for at least partially forming the surrounding structure.
15. The implantable urine evacuating device according to aspect 14, wherein the support element comprises a portion of a hinge 27 for hingedly connecting the support element to other support element for at least partially forming the surrounding structure.
16. The implantable urine evacuating device according to according to any one of the preceding aspects, wherein at least one of the support elements, the at least one abutment and the at least one constriction element comprises at least one curvature (C) adapted for the curvature of the urinary bladder.
17. The implantable urine evacuating device according to according to any one of the preceding aspects, further comprising an electrode arrangement configured to engage and electrically stimulate muscle tissue of the urinary bladder to exercise the muscle tissue to improve the conditions for long term implantation of the implantable urine evacuating device.
18. The implantable urine evacuating device according to according to any one of aspects 9-17, wherein the abutment comprises at least one cushioning element (30) configured to contact the urinary bladder, wherein the cushioning element is more resilient than the support element of aspects 11-17.
19. The implantable urine evacuating device according to according to any one of the preceding aspects, wherein:
20. The implantable urine evacuating device according to according to any one of the preceding aspects, wherein the second constriction device comprises a plurality of constriction elements axially distributed along a distal portion of the urinary bladder configured to sequentially, in a direction from proximal to distal, constrict the urinary bladder for evacuating urine from the urinary bladder.
21. The implantable urine evacuating device according to aspect 5, wherein the mechanical construction device comprises at least one mechanical constriction element (101a′) comprising an electric motor (M), a screw (701) and a plate (702), wherein the electric motor is configured to turn the screw in order to push the plate toward the urinary bladder in order to constrict the urinary bladder.
22. The implantable urine evacuating device according to aspect 2, wherein the first constriction device has an inner diameter of about 5-12 cm preferably about 8-11 cm in a non-constricted state, so as to house a bladder with corresponding size.
23. The implantable urine evacuating device according to aspect 2, wherein the second constriction device has an inner diameter of about 1-8 cm preferably about 2-5 cm in a non-constricted state, so as to house a bladder with corresponding size.
24. The implantable urine evacuating device according to 11 or 12, wherein the support element (24) and/or the surrounding structure (20) has a tapered form.
25. A method for evacuating urine from the urinary bladder (U) of a patient, with an implantable urine evacuating device (10) comprising a first constriction device (10a), a second constriction device (10b) and a controller (300) configured to control the first and second constriction devices, wherein the method comprises the steps of:
| Number | Date | Country | Kind |
|---|---|---|---|
| PCT/EP2021/073893 | Aug 2021 | WO | international |
| 2250204-1 | Feb 2022 | SE | national |
| 2250217-3 | Feb 2022 | SE | national |
This application is a 371 national entry of international Application PCT/EP2022/073763 filed on Aug. 26, 2022, which designates the US and claims priority to Swedish Application No 2250204-1, filed Feb. 18, 2022 and to Swedish Application No 2250217-3, filed Feb. 18, 2022, and to International Application No. PCT/EP2021/073893 filed Aug. 30, 2021, the entire contents of each of which are hereby incorporated by reference.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/EP2022/073763 | 8/26/2022 | WO |
