Patent Application
20250010067
The present invention relates to a system for treating a patient having a disorder related to a patient's intestine. More specifically, the treatment involves electrical stimulation of the patient's intestine. Also disclosed is a method of implantation and a method of use of such system.
Intestinal disorders may be caused by injury, birth defect, cancer or other diseases, such as constipation or incontinence. WO 2011/128124 A1 discloses a system for regulating the flow of intestinal contents through the intestine. In that particular application, a reservoir for intestinal contents is formed from surgically modified intestine that has been cut along a mutual contact line of laterally adjacent sections of a bent portion of intestine and connected so that the resulting upper and lower halves of the intestine form an intestinal wall of the reservoir, and the system is designed for emptying such intestinal reservoir. More specifically, the prior art system comprises a pump adapted to act on said intestinal wall so as to reduce the reservoir's volume, thereby emptying the reservoir. The pump may be an electrical stimulation type pump, a hydraulically acting type pump or/and a mechanically acting type pump. The system further comprises an entry valve upstream of the reservoir and an exit valve downstream of the reservoir.
The electrical stimulation type pump comprises an electrical stimulation device for electrically stimulating a muscle or neural tissue of said intestinal wall by applying electrical pulses to the intestinal wall so as to cause at least partial contraction thereof, in particular by a series of electrical pulses. For this purpose, the electrical stimulation apparatus comprises one or more electrodes adapted to generate the electrical pulses. This is a very gentle way of constricting the reservoir. By electrically stimulating different portions of said intestinal wall in a direction of natural intestinal contents flow over time, the intestinal contents are pumped along the intestinal reservoir and, thus, the intestinal reservoir is emptied. More specifically, the electrodes of the electrical stimulation type pump are mounted on one or more holding devices which are in the form of a cable or have any other longitudinal, stripe-like or rod-like or plate-like shape. A plurality of the electrodes may be arranged in one or more rows along the length of the holding devices. The longitudinal holding devices are arranged side by side, when implanted, so as to cover substantially the entire intestinal reservoir on one side or on opposing sides of the reservoir.
The holding devices are either embedded in a flexible web which allows the holding devices to follow movements of the intestinal reservoir when sections thereof are constricted individually due to selective electrical stimulation. Or the longitudinal holding devices are implanted in surgically created folds of the intestinal wall of the reservoir. Alternatively, the electrodes are directly invaginated in the intestinal wall one by one or in groups without being carried on a common holding device. It is further suggested in WO 2011/128124 A1 that, instead of providing a plurality of longitudinal holding devices with electrodes, the electrical stimulation device may be formed as an integral unit on at least one side of the reservoir to make handling and manufacture easier.
In addition to the electrical stimulation type pump, the pump disclosed in WO 2011/128124 A1 may comprise a constriction type pump implanted in the patient's body for at least partly constricting the intestinal reservoir mechanically or hydraulically by acting from outside on the intestinal wall. Therein, the electrical stimulation type pump and the constriction type pump may act on the same portions of the intestinal wall so as to pump the intestinal contents along the reservoir by, over time, electrically stimulating different portions of said intestinal wall and simultaneously constricting respective sections of the reservoir in the direction of natural intestinal contents flow. In particular, the constriction type pump in operation may constrict the intestinal reservoir only partly, in order not to damage the intestinal tissue, whereas complete constriction and, thus, emptying of the reservoir is obtained by additionally stimulating the intestinal wall portions electrically in a manner as described before.
Since due to the surgical modifications, the intestinal reservoir itself has lost its natural peristaltic capabilities, the electrical stimulation type pump may pump intestinal contents along the reservoir in a direction of natural intestinal contents flow by stimulating different portions of the intestinal wall in a wavelike (peristaltic) manner, e.g. when constriction of the reservoir caused by the constriction type pump is released, so as to improve the filling of the intestinal reservoir with intestinal contents supplied to the reservoir. An exit valve provided at the downstream end of the intestinal reservoir is closed while the reservoir is filling up, to prevent intestinal contents from escaping the reservoir unintentionally.
It is an object of the present invention to further improve the system for treating a patient having a disorder related to a patient's intestine which involves electrical stimulation of the patient's intestine. In this regard, the system may comprise all the features as described above in relation to WO 2011/128124 A1, but with some modifications as described hereinafter.
According to one aspect of the present disclosure, the system for treating a patient having a disorder related to a patient's intestine comprises a plurality of electrical stimulation devices having one or more electrodes for electrically stimulating muscle or neural tissue of the intestine, wherein each of the one or more electrical stimulation devices comprises a wireless energy receiver configured to receive energy for stimulating the muscle or neural tissue wirelessly.
This means that the electrical stimulation devices are not connected by wire, nor in any other way. Physically, the electrical stimulation devices are independent from each other. This way, they can be installed on or close to the intestine or even implanted in an intestinal wall and are able to follow any movement of the intestine. In particular, such intestinal movement may be caused by electrical stimulation via the respective electrical stimulation device and/or by constriction via the aforementioned constriction type pump and/or by constriction via any other mechanical or hydraulic or other type of constriction device. In other words, the one or more electrical stimulation devices are rather flexible and remain flexible over time since any danger that such flexibility may decrease due to fibrosis growing over and encapsulating the system and electrical stimulation devices is minimized, thanks to the physical independence of the electrical stimulation devices.
The system preferably comprises one or a plurality of wireless energy transmitters configured to transfer energy to some or all of the one or more electrical stimulation devices. Thus, one energy transmitter is provided for supplying energy to more than one electrical stimulation device. More specifically, either one wireless energy transmitter may be configured to transfer energy to all of the one or more electrical stimulation devices or at least one, preferably all, of the plurality of wireless energy transmitters may be configured to transfer energy to some of the one or more electrical stimulation devices. This way, the complexity of the system may be kept minimal. Of course, more than one energy transmitter may be provided, each one of them configured to supply energy to more than one electrical stimulation device.
The wireless energy receiver of each of the one or more electrical stimulation devices may include a secondary coil and at least one of the wireless energy transmitters, preferably each transmitter, may comprise a primary coil configured to induce a voltage in the secondary coil of some or all of the one or more electrical stimulation devices. This way, energy can be transmitted wirelessly from the energy transmitter to the energy receiver via the primary and secondary coils.
Alternatively, the system may comprise an individual wireless energy transmitter for each one of the one or more electrical stimulation devices for transferring energy individually to the respective one of the one or more electrical stimulation devices. In this case, in order to transmit energy wirelessly, the wireless energy receiver of each of the one or more electrical stimulation devices may include a secondary coil and each of the individual wireless energy transmitters may comprise a primary coil configured to transfer energy to the secondary coil of a respective one of the one or more electrical stimulation devices.
Preferably, RFID technology is used to transfer the energy wirelessly from the energy transmitter to the energy receiver. RFID technology is widely known, and transfer of energy via the aforementioned primary and secondary coils is a well-known way of transferring energy by RFID technology. More specifically, the wireless energy receiver may be configured to receive the energy via RFID pulses.
The system preferably comprises a feedback unit configured to provide feedback pertaining to the amount of energy received by the wireless energy receiver, such as via the RFID pulses, wherein the system is configured to adjust the amount of transferred energy based on the feedback. More specifically, the amount of RFID pulse energy that is being received may be adjusted based on the feedback such that the pulse frequency is successively raised until a satisfying level is reached.
Preferably, each of the one or more electrical stimulation devices comprises a rechargeable energy storage unit, such as a rechargeable battery or a capacitor, for temporarily storing at least part of the wirelessly received energy. The rechargeable energy storage unit may be charged over time so that an energy amount required by the electrode or electrodes of the respective electrical stimulation device for stimulating the muscle or neural tissue is available when needed. Such energy amount may be small anyways, as contraction of the muscle is autonomous once an activation potential in the corresponding nerve has been reached or exceeded by means of the electrical stimulation.
Preferably, each of the one or more electrical stimulation devices comprises an internal controller. The internal controller may serve various functions, the main function consisting in controlling the timing and amount of energy applied to the electrode or electrodes of the electrical stimulation device for stimulating the nerve or muscle tissue. Another important function consists in controlling and possibly storing away the amount of energy that is received via the wireless energy receiver. The internal controller may further serve to communicate with an external controller and/or with a remote controller. For instance, such communication may relate, inter alia, to the energy transfer via the energy receiver and/or to the timing and/or amount of energy to be applied to the electrode or electrodes.
In particular, the internal controller may be configured to wirelessly receive electrode control data for controlling stimulation of the muscle or neural tissue. Thus, not only the energy transfer but also data transfer is carried out wirelessly in order for the electrical stimulation devices to be physically independent from each other. Such data may be received either from an implanted external controller or from a remote controller outside the patient's body.
Preferably, the internal controller receives the electrode control data wirelessly via the wireless energy receiver. In other words, the same port may be used to receive both energy and data. In particular, the energy transferred to and received by the electrical stimulation device via the wireless energy receiver may be appropriately modulated, the modulation defining and, thus, carrying a signal which may be decoded by the internal controller and interpreted as data. This is a well-known technique, which is particularly known and used within the RFID technology. That is, an RFID signal may be used to transport both energy and information.
More specifically, the internal controller of each of the one or more electrical stimulation devices may be addressable individually by an external controller or remote controller using an individual code, i.e. a code which is specific to the respective internal controller. This is particularly useful where one external controller or remote controller is used to control more than one electrical stimulation device and/or where one wireless transmitter is used to transmit energy wirelessly to the wireless energy receivers of more than one electrical stimulation device. For instance, when electrical stimulation devices are to be activated sequentially, e.g. for stimulating the intestine in a wave-like manner, the respective electrical stimulation device may be addressed individually using the individual code of the corresponding internal controller. Typically, such individual code is placed at the beginning of the data transmitted to the internal controller. This way, only one or more desired electrical stimulation devices may be instructed at a given time to electrically stimulate a portion of the intestine and/or only one or more desired electrical stimulation devices will receive and possibly store energy received through the wireless energy receiver.
As mentioned before, the system may comprise an external controller configured to communicate with the internal controller wirelessly. The external controller is either an implantable external controller configured to be implanted within the patient's body or a remote controller configured to communicate directly with the internal controller from outside the patient's body. Alternatively, the system may comprise a remote controller configured to communicate with the implantable external controller from outside the patient's body. In the latter case, there are at least three types of controllers, the internal controller within each one of the electrical stimulation devices, at least one external controller inside the patient's body for communication with one or more of the internal controllers, and preferably only one remote controller outside the patient's body for communicating with the one or more implanted external controllers. The remote controller is preferably operable by the patient and/or a caretaker.
The remote controller may be configured to communicate with the implantable external controller via electric wiring. However, preferably, the remote controller is configured to communicate with the implantable external controller wirelessly, which is more convenient for the patient and/or care person. Energy transfer and/or data transfer between the remote controller and the implantable external controller may be realized in the same way as the energy and/or data transfer to (and from) the internal controller of the electrical stimulation devices. In any case, the remote controller is preferably configured so that it can be mounted to the patient's skin.
The system may comprise a large number of the electrical stimulation devices. These may be arranged at many different locations along the part of the intestine which is to be stimulated electrically, i.e. in one or more rows and/or on one or two or more than two sides of the intestine, in particular on two opposite sides thereof. For instance, 4 or 5 or 6 or 7 or 8 or 9 or 10 or 11 or 12 or more than 12 of the electrical stimulation devices may be provided. Each of the electrical stimulation devices may comprise a single electrode or a plurality of two or more electrodes.
In one embodiment of the present disclosure, the system is configured to electrically stimulate, by means of the electrodes of the one or more electrical stimulation devices, the muscle or neural tissue sufficiently for a muscle of the intestine to contract to an extent such that the intestine constricts. That is, the system may function as a constriction device by electrically stimulating contraction of the muscles in the intestine.
In this context, the one or more electrical stimulation devices may form part of an electrical stimulation type pump as described above in relation to the prior art disclosed in WO 2011/128124 A1, whose pump is configured to advance intestinal contents through the patient's intestine in a downstream direction, e.g. by successive electrical stimulation of different portions of the intestine in a wavelike, i.e. peristaltic, manner.
More specifically, in the same way as the system disclosed in WO 2011/128124 A1, the system described herein may be configured and is particularly suitable for use on a reservoir section of the intestine which is formed from surgically modified intestine that has been cut along a mutual contact line of laterally adjacent sections of a bent portion of intestine and connected so that the upper and lower halves of the cut intestine form an intestinal wall of the reservoir section. More specifically, at least the electrodes of the one or more electrical stimulation devices may be configured to be implanted in surgically created folds of the patient's intestine.
In addition to the one or more electrical stimulation devices, the system may further comprise at least one mechanical or hydraulic constriction device configured to be implanted outside the patient's intestine in close proximity thereto for constricting the intestine from the outside thereof. The electrical stimulation devices and the mechanical or hydraulic constriction device may be configured to act on the same part of the patient's intestine, as is generally known from WO 2011/128124 A1. In this context, the mechanical or hydraulic constriction device may form part of a pump that is configured to advance intestinal contents through the patient's intestine in a downstream direction. Alternatively, the mechanical or hydraulic constriction device may have the function of a valve configured to open and close the intestine by constriction to thereby control the flow of intestinal contents through the intestine, in particular into or out of the intestine. For instance, the valve may form an artificial sphincter close to the patient's rectum or close to a stoma of the patient. The electrical stimulation devices may support the respective function of the mechanical or hydraulic constriction device. They may individually or together form an emptying device for emptying a respective section of the patient's intestine.
In another embodiment of the present disclosure, the system is configured to electrically stimulate, by means of the electrodes of the one or more electrical stimulation devices, the muscle or neural tissue in an area of the intestine constricted by a medical device, such as the at least one mechanical or hydraulic constriction device sufficiently for increasing blood flow through the tissue of the intestine. The purpose thereof is to exercise the tissue wall which is in contact with the constriction device. The body tends to react to medical implants, 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, a mechanical or hydraulic or other type of constriction device may deprive the tissue cells of oxygen and nutrients, which may lead to deterioration of the tissue, atrophy and eventually necrosis. This may result in migration of the device, including migration through the tissue wall. It is therefore desirable to exercise the tissue cells so as to stimulate blood flow and increase tolerance of the tissue for pressure from the implant. In this context, it is preferable to configure the system such that electrical stimulation of the muscle or neural tissue for increasing blood flow through the tissue of the intestine is adjustable at a low level which is not enough to constrict the intestine.
According to a further aspect of the present disclosure, security of the system against fraudulent third-party intervention may be increased. This is particularly important in the context of wireless communication, which can easily be intercepted and then misused by third parties.
Accordingly, the system is preferably configured such that at least one of:
Preferably, the encrypted wireless communication includes encryption with a public key and decryption with a private key, such as the well-known RSA encryption. Other encryption methods may likewise be implemented. Preferably, the security level is further increased in that the private key may be a combined key derived by combining at least a first key and a second key.
Similarly, as regards the signing of the data transmitted wirelessly by a controller, such as by the aforementioned external controller or remote controller to the internal controller, the signing may involve a private key, whereas subsequent verification of the signed data may involve a corresponding public key.
Preferably, data communication involves both an encryption and a signature. The RSA encryption technology allows for both, encrypting the data and adding a digital signature to the data. For the encryption/decryption process, the sender uses a public key of the recipient for encrypting the data and the recipient uses his private key for subsequently decrypting the data, whereas for the signing/authentication process, the sender uses his private key to sign the (encrypted) data and the recipient uses the sender's public key to authenticate the signature.
As regards the authentication of a user which involves input of authentication data of the patient, the system may comprise a verification unit which is configured to obtain the authentication data of the patient. For instance, the verification unit may comprise at least one of a fingerprint reader, a retina scanner, a camera, a graphical user interface for inputting a code, and a microphone. Only after a positive verification by the verification unit will certain functions of the system be enabled. For instance, the positive verification may enable the controller to process certain data or may open a communication channel between two controllers of the system, such as a wireless communication channel.
Alternatively or in addition, the system may comprise a sensation generator for generating a sensation which is detectable by a sense of the patient. In this course, the patient may input into the system authentication data which relate to what the patient has sensed. Then, the authentication of the user may involve a verification by the verification unit that the authentication data input by the user matches data from the sensation generator which relate to the sensation generated by the sensation generator. Again, only after a positive verification by the verification unit will certain functions of the system be enabled. For instance, the positive verification may enable the controller to process certain data or may open a communication channel between two controllers of the system, such as a wireless communication channel.
In this context, the sensation generator may be configured to generate as the sensation detectable by the sense of the patient at least one of:
The electrodes may comprise a bare electrode portion configured to form a metal-tissue interface with the tissue of the intestinal wall, thereby allowing faradaic charge transfer to be the predominant charge transfer mechanism over said interface.
Alternatively, the electrodes may comprise an electrode portion at least partly covered by a dielectric material configured to form a dielectric-tissue interface with the tissue of the intestinal wall, thereby allowing for a faradaic portion of the charge transfer mechanism over said interface to be reduced.
The arrangement of the electrical stimulation devices may be configured such that at least two electrodes can be arranged on opposing sides of the patient's intestine.
Further, an external device configured for the communication with the implantable medical device when implanted in a patient is provided, the external device comprising: a display device and a housing unit configured to mechanically and disconnectably connect to the display device, wherein the housing comprises a first communication unit for receiving communication from the display device and a second communication unit for wirelessly transmitting communication to the implantable medical device.
According to one embodiment, the external device comprises a handheld electronic device.
According to one embodiment, the external device is configured for communicating with the implantable medical device for changing the operational state of an implantable medical device. The advantage of the embodiment is that the operational state of the implantable medical device can be changed remotely.
According to one embodiment, the first communication unit is a wireless communication unit for wireless communication with the display device. The advantage of the embodiment is that the display device can be communicated without the need of electric wires.
According to one embodiment, the first communication unit is configured to communicate wirelessly with the display device using a first communication frequency and the second communication unit is configured to communicate wirelessly with the implantable medical device using a second communication frequency, wherein the first and second communication frequencies are different. The advantage of the embodiment is that the likelihood of interferences is reduced.
According to one embodiment, the second communication unit is configured to communicate wirelessly with the implantable medical device using electromagnetic waves at a frequency below 100 kHz.
According to one embodiment, the second communication unit is configured to communicate wirelessly with the implantable medical device using electromagnetic waves at a frequency below 40 kHz. The advantage of the embodiment is that titanium, which is commonly used for medical devices, is transparent for electromagnetic waves below 40 kHz.
According to one embodiment, the first communication unit is configured to communicate wirelessly with the display device using electromagnetic waves at a frequency above 100 kHz. The advantage of the embodiment is that the frequency spectrum below 100 kHz remains noise free for the communication with the medical implantable device.
According to one embodiment, the first communication unit is configured to communicate wirelessly with the display device using a first communication protocol and the second communication unit is configured to communicate wirelessly with the implantable medical device using a second communication protocol, wherein the first and second communication protocols are different. The advantage of the embodiment is that the protocol can be independently chosen for the communication of the first and second communication units, depending on which protocol suits the needs of the communication units better.
According to one embodiment, the housing unit comprises a first antenna configured for wireless communication with the display device and a second antenna configured for wireless communication with the implantable medical device. The advantage of the embodiment is that the antenna can be independently chosen for the communication of the first and second communication units, depending on which antenna suits the needs of the communication units better.
According to one embodiment, the first communication unit is a wire-based communication unit for wire-based communication with the display device. The advantage of the embodiment is that the communication of the first communication unit is reliable and secure.
According to one embodiment, the display device comprises a first communication unit for communication with the housing unit and a second communication unit for wireless communication with a second external device. The advantage of the embodiment is that communication with an additional external device becomes possible, thereby introducing redundancy and reliability.
According to one embodiment, the second communication unit of the display device is configured for communicating with the second external device over the internet. The advantage of the embodiment is that the display device can communicate with devices far away.
According to one embodiment, the first communication unit of the display device is a wireless communication unit for wireless communication with the housing unit. The advantage of the embodiment is that the communication unit can be connected to the housing unit without the use of wires.
According to one embodiment, the first communication unit of the display device is configured to communicate wirelessly with the housing unit using a first communication frequency and the second communication unit of the display device is configured to communicate wirelessly with the second external device using a second communication frequency, wherein the first and second communication frequencies are different. The advantage of the embodiment is that the likelihood of interferences is reduced and the signal to interference and noise ratio is increased.
According to one embodiment, the first communication unit of the display device is configured to communicate wirelessly with the housing unit using a first communication protocol and the second communication unit of the display device is configured to communicate wirelessly with the second external device using a second communication protocol, wherein the first and second communication protocols are different. The advantage of the embodiment is that the protocol can be independently chosen for the communication of the first and second communication units, depending on which protocol suits the needs of the communication units better.
According to one embodiment, the display device comprises a first antenna configured for wireless communication with the housing and a second antenna configured for wireless communication with the second external device. The advantage of the embodiment is that the antenna can be independently chosen for the communication of the first and second communication units, depending on which antenna suits the needs of the communication units better.
According to one embodiment, the first communication unit is a wire-based communication unit for wire-based communication with the housing unit. The advantage of the embodiment is that the communication of the first communication unit is reliable and secure.
According to one embodiment, the display device is configured to display a user interface to the patient. The advantage of the embodiment is that the patient can use his familiar display device to communicate with the housing unit.
According to one embodiment, the housing unit is configured to transmit information pertaining to the display of the user interface to the display device. The advantage of the embodiment is that the patient can receive information using his familiar display device.
According to one embodiment, the display device is configured to receive from the patient input pertaining to communication to or from the implantable medical device and transmit signals based on the received input to the housing unit. The advantage of the embodiment is that the patient can use his familiar display device to communicate with the housing unit.
According to one embodiment, the display device comprises a touch screen configured to display the user interface and receive the input from the patient. The advantage of the embodiment is that the patient can use a familiar way of handling the information.
According to one embodiment, the housing unit is configured to display a user interface to the patient. The advantage of the embodiment is that the housing unit can receive user input.
According to one embodiment, the first communication unit of the housing unit is configured to receive communication from the implantable medical device pertaining to input from the patient and wirelessly transmit signals based on the received input to the implantable medical device, using the second communication unit. The advantage of the embodiment is that the housing unit acts as an extra node in the communication between the display device and the medical implantable device, thereby enabling it to monitor the communication.
According to one embodiment, the second communication unit of the housing unit is configured for wireless communication with the implantable medical device using a standard network protocol. The advantage of the embodiment is that the implementation of the communication units is cheap and the protocols are reliable.
According to one embodiment, the standard network protocol is one of 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 communication unit of the housing unit comprises a Bluetooth transceiver.
According to one embodiment, the second communication unit of the housing unit is configured for wireless communication with the implantable medical device using a proprietary network protocol. The advantage of the embodiment is that the housing unit is compatible with implantable medical devices that use proprietary network protocols.
According to one embodiment, the second communication unit of the housing unit comprises a UWB transceiver. The advantage is that high data rates can be communicated via the second communication unit.
According to one embodiment, the first communication unit of the housing unit is configured for wireless communication with the display device using a standard network protocol. The advantage of the embodiment is that the implementation of the communication units is cheap and the protocols are reliable.
According to one embodiment, the standard network protocol is an NFC-type protocol. The advantage of the embodiment is that the distance between the communicating devices is limited, thereby protecting against eavesdropping attacks.
According to one embodiment, the first communication unit of the housing unit is configured for wireless communication with the display device using a proprietary network protocol. The advantage of the embodiment is that the housing unit is compatible with implantable medical devices that use proprietary network protocols.
According to one embodiment, a communication range of the first communication unit of the housing unit is less than a communication range of the second communication unit of the housing unit. The advantage of the embodiment is that energy is saved by selecting the first communication unit when its range suffices.
According to one embodiment, a communication range of the first communication unit of the display device is less than a communication range of the second communication unit of the display device. The advantage of the embodiment is that energy is saved by selecting the first communication unit when its range suffices.
According to one embodiment, at least one of the housing unit and the display device is configured to allow communication between the housing unit and the display device on the basis of a distance between the housing unit and the display device. The advantage of the embodiment is that the distance is used as a safety and authorization factor.
According to one embodiment, at least one of the housing unit and the display device is configured to allow communication between the housing unit and the display device on the basis of the housing unit being mechanically connected to the display device. The advantage of the embodiment is that the safety against a man-in-the-middle attacks is increased.
According to one embodiment, the housing unit is configured to allow communication between the housing unit and the implantable medical device on the basis of a distance between the housing unit and the implantable medical device. The advantage of the embodiment is that the distance is used as a safety and authorization factor.
According to one embodiment, the housing unit further comprises an encryption unit configured to encrypt communication received from the display device. The advantage of the embodiment is that the encrypted communication is protected against unwanted third party access.
According to one embodiment, the housing unit is further adapted to transmit the encrypted communication to the implantable medical device using the second communication unit. The advantage of the embodiment is that the encrypted communication is protected against unwanted third party access.
According to one embodiment, the second communication unit of the display device is configured to be disabled to enable at least one of: communication between the display device and the housing unit, and communication between the housing unit and the implantable medical device.
The display device in any of the embodiments described herein may be a wearable device or a handset. The advantage of the embodiment is that the device is mobile and can be used where needed.
According to one embodiment, the housing unit comprises a case for the wearable device or handset. The advantage of the embodiment is that the wearable device or handset can be protected from mechanical damage.
Further, a housing unit configured for communication with the implantable medical device when implanted in a patient is provided, the housing unit being configured to mechanically connect to a display device and comprising a first communication unit for communication with the display device and a second communication unit for wireless communication with the implantable medical device.
According to one embodiment, the display device is a wearable device or a handset and the housing unit comprises a case for the wearable device or handset.
According to one embodiment, the first communication unit is a wireless communication unit for wireless communication with the display device.
According to one embodiment, the first communication unit is configured to communicate wirelessly with the display device using a first communication frequency and the second communication unit is configured to communicate wirelessly with the implantable medical device using a second communication frequency, wherein the first and second communication frequencies are different.
According to one embodiment, the housing unit is configured to transmit information pertaining to the display of a user interface to the display device.
According to one embodiment, the housing unit is configured to receive patient input from the display device.
According to one embodiment, the housing unit is configured to display a user interface to the patient.
According to one embodiment, the housing unit is configured to allow communication between the housing unit and the display device on the basis of a distance between the housing unit and the display device.
According to one embodiment, the housing unit is configured to allow communication between the housing unit and the display device on the basis of the housing unit being mechanically connected to the display device.
According to one embodiment, the housing unit is configured to allow communication between the housing unit and the implantable medical device on the basis of a distance between the housing unit and the implantable medical device.
According to one embodiment, the housing unit further comprises an encryption unit configured to encrypt communication received from the display device.
According to one embodiment, the housing unit is further adapted to transmit the encrypted communication to the implantable medical device using the second communication unit.
According to one embodiment, the minimum bounding box of the housing unit and the display device, when the housing is mechanically connected to the display device, is no more than 10% wider, 10% longer or 100% higher than the minimum bounding box of the display device.
According to one embodiment, the housing unit comprises one or more switches configured to be used by the patient when the housing is not mechanically connected to the display device.
According to one embodiment, the switches are at least partly covered by the display device, when the display device is mechanically connected to the housing unit.
According to one embodiment, at least a part of the housing bends in order to mechanically connect to the display device.
According to one embodiment, at least a part of the housing is configured to clasp the display device.
According to one embodiment, the housing is configured to cover at least one side of the display device when it is mechanically connected to the display device.
According to one embodiment, the housing is configured to be mechanically connected to the display device by a device which is mechanically connected to the housing and the display device.
Further, an implantable controller for the implantable medical device is provided. The implantable controller comprises a wireless transceiver for communicating wirelessly with an external device, a security module, and a central unit configured to be in communication with the wireless transceiver, the security module and the implantable medical device. The wireless transceiver is configured to receive communication from the external device including at least one instruction to the implantable medical device and transmit the received communication to the central unit. The central unit is configured to send secure communication to the security module derived from the communication received from the external device, and the security module is configured to decrypt at least a portion of the secure communication and/or verify the authenticity of the secure communication. The security module is configured to transmit a response communication to the central unit and the central unit is configured to communicate the at least one instruction to the implantable medical device, the at least one instruction being based on the response communication or on a combination of the response communication and the communication received from the external device.
According to one embodiment, the security module comprises a set of rules for accepting communication from the central unit.
According to one embodiment, the wireless transceiver is configured to be placed in an off-mode, in which no wireless communication can be transmitted or received by the wireless transceiver, and wherein the set of rules comprises a rule stipulating that communication from the central unit is only accepted when the wireless transceiver is placed in the off-mode.
According to one embodiment, the set of rules comprises a rule stipulating that communication from the central unit is only accepted when the wireless transceiver has been placed in the off-mode for a specific time period.
According to one embodiment, the central unit is configured to verify a digital signature of the received communication from the external device.
According to one embodiment, the set of rules comprises a rule stipulating that communication from the central unit is only accepted when the digital signature of the received communication has been verified by the central unit.
According to one embodiment, the central unit is configured to verify the size of the received communication from the external device.
According to one embodiment, the set of rules comprises a rule stipulating that communication from the central unit is only accepted when the size of the received communication has been verified by the central unit.
The wireless transceiver of any of the preceding embodiments may be configured to receive a message from the external device being encrypted with at least a first and second layer of encryption and the central unit may be configured to decrypt a first layer of decryption and transmit at least a portion of the message comprising the second layer of encryption to the security model. The security module may be configured to decrypt the second layer of encryption and transmit a response communication to the central unit based on the portion of the message decrypted by the security module.
According to one embodiment, the central unit may be configured to decrypt a portion of the message comprising a digital signature such that the digital signature can be verified by the central unit.
According to one embodiment, the central unit is configured to decrypt a portion of the message comprising message size information such that the message size can be verified by the central unit.
According to one embodiment, the central unit is configured to decrypt a first and second portion of the message, and the first portion comprises a checksum for verifying the authenticity of the second portion.
According to one embodiment, the response communication transmitted from the security module comprises a checksum, and the central unit may be configured to verify the authenticity of at least a portion of the message decrypted by the central unit using the received checksum.
According to one embodiment, the set of rules comprises a rule related to the rate of data transfer between the central unit and the security module.
The security module in any of the embodiments herein may be configured to decrypt a portion of the message comprising a digital signature, encrypted with the second layer of encryption, such that the digital signature can be verified by the security module.
The central unit may be configured such that it is only capable of decrypting a portion of the communication received from the external device when the wireless transceiver is placed in the off-mode.
According to one embodiment, the central unit is only capable of communicating the at least one instruction to the implantable medical device when the wireless transceiver is placed in the off-mode.
According to one embodiment, the implantable controller is configured to receive, using the wireless transceiver, a message from the external device comprising a first non-encrypted portion and a second encrypted portion, decrypt the encrypted portion, and use the decrypted portion to verify the authenticity of the non-encrypted portion.
According to one embodiment, the central unit is configured to transmit the encrypted portion to the security module, receive a response communication from the security module based on information contained in the encrypted portion being decrypted by the security module, and use the response communication to verify the authenticity of the non-encrypted portion.
According to one embodiment, the non-encrypted portion comprises at least a portion of the at least one instruction to the implantable medical device.
The implantable controller may be configured to receive, using the wireless transceiver, a message from the external device comprising information related to at least one of a physiological parameter of the patient and a physical parameter of the implanted medical device and use the received information to verify the authenticity of the message.
The physiological parameter of the patient may comprise at least one of: a temperature, a heart rate and a saturation value.
The physical or functional parameter of the implanted medical device may comprise at least one of: a current setting or value of the implanted medical device, a prior instruction sent to the implanted medical device and an ID of the implanted medical device.
According to one embodiment, the portion of the message comprising the information is encrypted, and the central unit is configured to transmit the encrypted portion to the security module and receive a response communication from the security module based on the information having been decrypted by the security module.
According to one embodiment, the security module comprises a hardware security module comprising at least one hardware-based key. The hardware-based key may correspond to a hardware-based key in the external device, which may be a hardware-based key on a key-card connectable to the external device.
According to one embodiment, the security module comprises a software security module comprising at least one software-based key. The software-based key may correspond to a software-based key in the external device. The software-based key may correspond to a software-based key on a key-card connectable to the external device. The security module may in any of the embodiments comprise a combination of a software-based key and a hardware-based key.
In any of the preceding embodiments, the implantable controller may comprise at least one crypto-processor.
The wireless transceiver may in any of the embodiments be configured to receive communication from a handheld external device.
According to one embodiment, the at least one instruction to the implantable medical device may comprise an instruction for changing an operational state of the implantable medical device.
The wireless transceiver may be configured to communicate wirelessly with the external device using electromagnetic waves at a frequency below 100 kHz or at a frequency below 40 kHz.
According to one embodiment, the wireless transceiver is configured to communicate wirelessly with the external device using a first communication protocol, and the central unit is configured to communicate with the security module using a second different communication protocol.
In any of the embodiments, the wireless transceiver may be configured to communicate wirelessly with the external device using a standard network protocol. The standard network protocol may be selected from a list comprising RFID-type protocols, WLAN-type protocols, Bluetooth type protocols, BLE-type protocols, NFC-type protocols, 3G/4G/5G-type protocols, and GSM-type protocols.
The wireless transceiver may in some embodiments be configured to communicate wirelessly with the external device using a proprietary network protocol.
According to one embodiment, the wireless transceiver comprises a UWB transceiver.
According to one embodiment, the security module and/or the central unit and/or the wireless transceiver are comprised in the controller.
The external unit in any of the embodiments herein may be a wearable device or a handset. The advantage of the embodiment is that the device is mobile and can be used where needed.
Further, the implantable medical device may comprise a receiving unit. The implantable medical device comprises at least one coil configured for receiving transcutaneously transferred energy, a measurement unit configured to measure a parameter related to the energy received by the coil, a variable impedance electrically connected to the coil, a switch placed between the variable impedance and the coil for switching off the electrical connection between the variable impedance and the coil. The implantable medical device further comprises a controller configured to control at least one of the variable impedance for varying the impedance and thereby tune the coil based on the measured parameter, and the switch for switching off the electrical connection between the variable impedance and the coil in response to when the measured parameter exceeds a threshold value.
According to one embodiment, the controller is configured to vary the variable impedance in response to when the measured parameter exceeds a threshold value.
According to one embodiment, the measurement unit is configured to measure a parameter related to the energy received by the coil over a time period.
According to one embodiment, the measurement unit is configured to measure a parameter related to a change in energy received by the coil.
According to one embodiment, the first switch is placed at a first end portion of the coil, and the implantable medical device further comprises a second switch placed at a second end portion of the coil such that the coil can be completely disconnected from other portions of the implantable medical device.
According to one embodiment, the receiving unit is configured to receive transcutaneously transferred energy in pulses according to a pulse pattern, and the measurement unit is configured to measure a parameter related to the pulse pattern.
According to one embodiment, the controller is configured to control the variable impedance in response to when the pulse pattern deviates from a predefined pulse pattern.
According to one embodiment, the controller is configured to control the switch for switching off the electrical connection between the variable impedance and the coil in response to the pulse pattern deviating from a predefined pulse pattern.
According to one embodiment, the measurement unit is configured to measure a temperature in the implantable medical device or in the body of the patient, and the controller is configured to control the first and second switch in response to the measured temperature.
According to one embodiment, the variable impedance comprises a resistor and a capacitor, a resistor and an inductor and/or an inductor and a capacitor.
The variable impedance may comprise a digitally tuned capacitor. The variable impedance may comprise a digital potentiometer. The variable impedance may comprise a variable inductor.
According to one embodiment, the variation of the impedance is configured to lower the active power that is received by the receiving unit.
According to one embodiment, the variable impedance is placed in series with the coil.
According to one embodiment, the variable impedance is placed parallel to the coil.
According to one embodiment, the implantable medical device further comprises an energy storage unit connected to the receiving unit. The energy storage unit is configured to store energy received by the receiving unit.
As mentioned before, the system as described above is particularly useful for use in a valve such as an artificial sphincter. Therefore, according to another aspect of the present disclosure, an artificial sphincter may be configured, when implanted, to act on a wall of an intestine of a patient so as to restrict flow of intestinal contents out of the intestine and may comprise a system as described herein.
Likewise, the system as described above is particularly useful for use in an emptying device. Therefore, according to another aspect of the present disclosure, an emptying device may be configured, when implanted, to act on a wall of an intestine of a patient so as to advance intestinal contents contained in the intestine out of the intestine and may comprise a system as described herein.
Accordingly, a method of implanting a system for treating a patient having a disorder related to the patient's intestine comprises the steps of:
The method of implanting the system may comprise further steps as described above and in more detail hereinafter.
A method of using the system, the artificial sphincter or the emptying device accordingly comprises the step of wirelessly transmitting energy to and receiving the energy by the energy receiver. The method of using the system may comprise further steps as described above and in more detail hereinafter.
A further aspect of the present disclosure relates to the mitigation of fibrin creation caused by contact between a medical implant, such as the above-discussed implantable system, and the tissue or flowing blood of a patient. As is well known, 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 leading to the 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 has certain side effects that are undesirable.
In general, 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.
Thus, 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. However, 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.
Implants may also cause infections of different sorts. Bacterial colonization that leads 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.
Thus, according to this further aspect of the present disclosure, in order to mitigate fibrin creation caused by contact between components of the above-discussed implantable system, and the tissue or flowing blood of a patient, the implantable components of the system may comprise a specific coating arranged on the respective outer surface of the component. The coating may comprise at least one layer of a biomaterial. The biomaterial is preferably fibrin-based. The coating may comprise at least one drug or substance with antithrombotic and/or antibacterial and/or antiplatelet characteristics. The drug or substance may be encapsulated in a porous material.
There may be provided a second coating arranged on the first coating. The second coating may be a different biomaterial than said first coating. In particular, the first coating may comprise a layer of perfluorocarbon chemically attached to the surface and the second coating may comprise a liquid perfluorocarbon layer.
Further preferably, the surface may comprise a metal, such as at least one of titanium, cobalt, nickel, copper, zinc, zirconium, molybdenum, tin or lead.
Finally, the surface may comprise a micro pattern, wherein the micro pattern may be etched into the surface prior to insertion into the body. The layer of a biomaterial may be coated on the micro pattern.
A further aspect of the present disclosure relates to an implantable energized medical device, which may advantageously be combined with the disclosed system for treating a patient having a disorder related to a patient's intestine and which is configured to be held in position by a tissue portion of a patient, 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 being 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 first and second cross-sectional areas, such that the first portion and second portion are prevented from travelling through the hole in the tissue portion in a direction perpendicular to the first, second and third planes, the connecting portion and second portion are configured to form a connecting interface between the connecting portion and the second portion, and the second portion extends along a first direction being parallel to the second plane, wherein the second portion has a lengthwise cross-sectional area along the first direction, wherein a second lengthwise cross-sectional area is smaller than a first lengthwise cross-sectional area and wherein the first lengthwise cross-sectional area is located closer to said connecting interface with regard to the first direction.
In some embodiments, the second portion has a first end and a second end opposing the first end along the first direction, wherein the second portion has a length between the first and second end, and wherein the second portion has an intermediate region and a distal region, wherein the intermediate region is defined by the connecting interface between the connecting portion and the second portion, and the distal region extends from the connecting interface between the connecting portion and the second portion to the second end.
In some embodiments, the lengthwise cross-sectional area of the second portion decreases continuously from an end of the intermediate region towards the second end.
In some embodiments, the lengthwise cross-sectional area of the second portion decreases linearly from an end of the intermediate region towards the second end.
In some embodiments, the lengthwise cross-sectional area of the second portion decreases stepwise from an end of the intermediate region towards the second end.
In some embodiments, the distal region of the second portion is conically shaped.
In some embodiments, the second portion has rotational symmetry along the first direction.
In some embodiments, the second surface of the second portion is substantially perpendicular to a central extension of the connecting portion.
In some embodiments, the second surface of the second portion is substantially parallel to the second plane.
In some embodiments, the second surface of the second portion is substantially flat and configured to form a contact area to the second tissue surface, and wherein the second portion further comprises a lower surface facing away from the first portion configured to taper towards the second end.
In some embodiments, the second portion has a proximal region, wherein the proximal region extends from the first end to the connecting interface between the connecting portion and the second portion.
In some embodiments, the lengthwise cross-sectional area of the second portion decreases continuously from an end of the intermediate region towards the first end.
In some embodiments, the lengthwise cross-sectional area of the second portion decreases linearly from an end of the intermediate region towards the first end.
In some embodiments, the lengthwise cross-sectional area of the second portion decreases stepwise from an end of the intermediate region towards the first end.
In some embodiments, the proximal region of the second portion is conically shaped.
In some embodiments, the first and second ends comprise an elliptical point respectively.
In some embodiments, the first and second ends comprise a hemispherical end cap respectively.
In some embodiments, the second portion has at least one circular cross-section along the length between the first and second end.
In some embodiments, the second portion has at least one oval cross-section along the length between the first and second end.
In some embodiments, the second portion has at least one elliptical cross-section along the length between the first and second end.
In some embodiments, the second portion has said length in a direction being different to a central extension of the connecting portion.
In some embodiments, the connecting interface between the connecting portion and the second portion is eccentric with respect to the second portion.
In some embodiments, the connecting interface between the connecting portion and the second portion is eccentric, with respect to the second portion, in the first direction, but not in a second direction being perpendicular to the first direction.
In some embodiments, the connecting interface between the connecting portion and the second portion is eccentric, with respect to the second portion, in the first direction and in a second direction being perpendicular to the first direction.
In some embodiments, the second direction is parallel to the second plane.
In some embodiments, the proximal region and the distal region comprises the second surface configured to engage the second surface of the second side of the tissue portion.
In some embodiments, the second portion is tapered from the first end to the second end.
In some embodiments, the second portion is tapered from the intermediate region of the second portion to each of the first end and second end.
In some embodiments, the first portion has a maximum dimension being in the range of 10 to 40 mm, such as in the range of 10 to 30 mm, such as in the range of 15 to 25 mm.
In some embodiments, the first portion has a diameter being in the range of 10 to 40 mm, such as in the range of 10 to 30 mm, such as in the range of 15 to 25 mm.
In some embodiments, the connecting portion has a maximum dimension in the third plane in the range of 2 to 20 mm, such as in the range of 2 to 15 mm, such as in the range of 5 to 10 mm.
In some embodiments, the second portion has 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 35 to 60 mm.
In some embodiments, the first portion has one or more of a spherical shape, an ellipsoidal shape, a polyhedral shape, an elongated shape, and a flat disk shape.
In some embodiments, the connecting portion has one of an oval cross-section, an elongated cross-section, and a circular cross-section, in a plane parallel to the third plane.
In some embodiments, the distal region is configured to be directed downwards in a standing patient.
In some embodiments, the first portion has a first height, and the second portion has a second height, both heights being in a direction perpendicular to the first and second planes, wherein the first height is smaller than the second height.
In some embodiments, the first height is less than ⅔ of the second height, such as less than ½ of the second height, such as less than ⅓ of the second height.
In some embodiments, the second end of the second portion comprises connections for connecting to an implant being located in a caudal direction from a location of the implantable energized medical device in the patient.
In some embodiments, the first end of the second portion comprises connections for connecting to an implant being located in a cranial direction from a location of the implantable energized medical device in the patient.
In some embodiments, the connecting portion further comprises a fourth cross-sectional area in a fourth plane, wherein the fourth plane is parallel to the first, second and third planes, and wherein the third cross-sectional area is smaller than the fourth cross-sectional area.
In some embodiments, the connecting portion comprises a protruding element comprising the fourth cross-sectional area.
In some embodiments, the first surface is configured to engage the first tissue surface of the first side of the tissue portion.
In some embodiments, the first portion comprises a first wireless energy receiver configured to receive energy transmitted wirelessly from an external wireless energy transmitter.
In some embodiments, the first portion comprises an internal wireless energy transmitter.
In some embodiments, the second portion comprises a second wireless energy receiver.
In some embodiments, the first portion comprises a first energy storage unit.
In some embodiments, the second portion comprises a second energy storage unit.
In some embodiments, at least one of the first and second energy storage unit is a solid-state battery.
In some embodiments, the solid-state battery is a thionyl-chloride battery.
In some embodiments, 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, and 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.
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, at least one of the first and second controller is connected to a wireless transceiver for communicating wirelessly with an external device.
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, 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.
In some embodiments, the second controller is connected to the second wireless communication receiver for receiving wireless communication from the first portion.
In some embodiments, the first wireless energy receiver comprises a first coil and the internal wireless energy transmitter comprises a second coil.
In some embodiments, 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.
In some embodiments, at least one of the coils are embedded in a ceramic material.
In some embodiments, the implantable energized medical device further comprises 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.
In some embodiments, the portion of the housing made from a ceramic material comprises at least one coil embedded in the ceramic material.
In some embodiments, the implantable energized medical device further comprises 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.
In some embodiments, the portion of the housing made from a ceramic material comprises at least one coil embedded in the ceramic material.
In some embodiments, the second portion comprises at least a portion of an operation device for operating an implantable body engaging portion.
In some embodiments, the second portion comprises at least one electrical motor.
In some embodiments, the second portion comprises a transmission configured to reduce the velocity and increase the force of the movement generated by the electrical motor.
In some embodiments, the transmission is configured to transfer a week force with a high velocity into a stronger force with lower velocity.
In some embodiments, the transmission is configured to transfer a rotating force into a linear force.
In some embodiments, the transmission comprises a gear system.
In some embodiments, 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.
In some embodiments, the second portion comprises at least one hydraulic pump.
In some embodiments, the hydraulic pump comprises a pump comprising at least one compressible hydraulic reservoir.
In some embodiments, the implantable energized 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, wherein 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.
In some embodiments, 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.
In some embodiments, the second portion comprises a force transferring element configured to mechanically transfer force from the second portion to an implanted body engaging portion.
In some embodiments, the second portion comprises a force transferring element configured to hydraulically transfer force from the second portion to an implanted body engaging portion.
In some embodiments, 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.
In some embodiments, the first portion comprises an injection port for injecting fluid into the first portion.
In some embodiments, the connecting portion comprises a conduit for transferring a fluid from the first portion to the second portion.
In some embodiments, the conduit is arranged to extend through the hollow portion of the connecting portion.
In some embodiments, 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.
In some embodiments, a wall portion of the first chamber is resilient to allow an expansion of the first chamber.
In some embodiments, 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.
In some embodiments, the first hydraulic system comprises a first hydraulic pump and the second hydraulic systems comprises a second hydraulic pump.
In some embodiments, each of the first and second hydraulic systems comprises a reservoir for holding hydraulic fluid.
In some embodiments, the implantable energized 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.
In some embodiments, the first surface is configured to engage the first tissue surface of the first side of the tissue portion.
In some embodiments, the first, second and third planes are parallel to a major extension plane of the tissue.
In some embodiments, the fourth plane is parallel to a major extension plane of the tissue.
A further aspect of the present disclosure relates to an implantable energized medical device, which may advantageously be combined with the disclosed system for treating a patient having a disorder related to a patient's intestine and which is configured to be held in position by a tissue portion of a patient, 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.
A further aspect of the present disclosure relates to an implantable energized medical device, which may advantageously be combined with the disclosed system for treating a patient having a disorder related to a patient's intestine and which is configured to be held in position by a tissue portion of a patient, 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.
A further aspect of the present disclosure relates to an implantable energized medical device, which may advantageously be combined with the disclosed system for treating a patient having a disorder related to a patient's intestine and which is configured to be held in position by a tissue portion of a patient, 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.
A further aspect of the present disclosure relates to an implantable energized medical device, which may advantageously be combined with the disclosed system for treating a patient having a disorder related to a patient's intestine and which is configured to be held in position by a tissue portion of a patient, 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 embodiment of the present inventive concept, an implantable device for exerting a force on a body portion of a patient is provided, the implantable device comprising: an implantable energized medical device and an implantable element configured to exert a force on a body portion of the patient.
In some embodiments, the implantable element configured to exert a force on a body portion of the patient is an implantable hydraulic constriction device.
In some embodiments, the implantable hydraulic constriction device is configured for constricting an intestine of the patient.
In some embodiments, the implantable hydraulic constriction device comprises an implantable hydraulic constriction device for constricting a colon or rectum of the patient.
In some embodiments, the implantable hydraulic constriction device comprises an implantable hydraulic constriction device for constricting the intestine at a region of a stoma of the patient.
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 may 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 are thus to be seen as complementing each other in describing the fundamental idea of the feature and thereby showing the feature's versatility.
Restriction of the intestine is to be understood as any operation decreasing a cross-sectional area of the intestine. The restriction may decrease the flow of matter in the intestine or may completely close the intestine such that no matter can pass. Constriction is to be understood as a special way of restricting the intestine, namely a restriction by constriction, e.g. by means of a mechanical or hydraulic constriction device acting on the intestine from its outside and thereby constricting it.
A controller is to be understood as any unit capable of controlling at least a part of the system. A controller may include a motor and/or pump or any another operational device for operating at least part of the system. It may be separate from the electrical stimulation device and/or mechanical or hydraulic constriction device and may be adapted to control only the operation thereof. Preferably, a controller includes a CPU which enables the controller to process data. A control signal is to be understood as any signal capable of carrying information and/or electric power such that the electrical stimulation device and/or mechanical or hydraulic constriction device or any other part of the system can be controlled directly or indirectly.
The system for treating the patient's intestine involves electrical stimulation thereof by a plurality of electrical stimulation devices 10. Each of the electrical stimulation devices 10 may comprise one or more electrodes 11. In the embodiment shown, an electrical stimulation device 10 comprises seven electrodes 11. The electrodes 11 in each of the electrical stimulation devices 10 may be interconnected by an electrical wire 12, which means that those electrodes 11 are energized simultaneously when a voltage is applied to the wire 12. In the embodiment shown, the electrical wire 12 with the electrodes 11 connected thereto is arranged along the mutual contact line where the upper and lower halves of the cut intestine are sewn together by sutures 101. Alternatively, the electrodes 11 may be arranged at different locations of the intestine 100.
Each one of the electrical stimulation devices 10 comprises a wireless energy receiver R configured to receive energy for wirelessly stimulating the muscle or neural tissue of the intestine 100. Thus, the electrical stimulation devices 100 are not physically interconnected but are independent from each other. As can be seen from the side view shown in
In the embodiment shown in
Energy transfer between the wireless energy transmitters T and the wireless energy receivers R is preferably carried out via cooperating antennas, such as a primary coil on each of the transmitters T and a secondary coil on each of the receivers R, wherein the primary coils are configured to induce a voltage in the associated secondary coil, for which reason the wireless energy transmitters and receivers should be arranged close to each other, when implanted.
The primary and secondary coils of the wireless transmitters T and receivers R allow for using RFID technology to transfer the energy from the energy transmitter to the energy receiver. This technology is well established. In particular, the wireless energy receivers R may be configured to receive the energy via RFID pulses.
In turn, the wireless energy transmitters T do not necessarily need to maintain flexibility over time and, therefore, they are each connected to a controller via electric wiring 13. The controller is referenced with C11 representing an “external” controller as compared to an internal controller which may make part of the electrical stimulation devices 10, as will be described herein after. More specifically, the external controller C11 is an implanted external controller. Here, implantation is under the skin such that it can be actuated manually by means of a switch 14, which may have the form of a press button. In particular, the switch 14 may be implanted under the skin, as shown in
Furthermore, an energy storage unit E, which is rechargeable, is connected to the external controller C11 so as to provide energy to the wireless energy transmitters T when controlled accordingly by the external controller C11. The energy storage unit is rechargeable wirelessly through the patient's skin 200, as indicated in
Accordingly, when the system is implanted and used by a patient or by a care person, one may actuate the switch 14 implanted underneath the skin 200 by pressing thereon, which initiates the controller C11 so as to run a program installed in a CPU of the controller C11. According to such program, the controller C11 will release energy from the energy storage unit E sequentially to the electrical stimulation devices 10. Consequently, different parts of the intestine 100 are electrically stimulated at different times so that they contract and, thereby, restrict the volume inside the intestine 100. This way, intestinal contents contained inside the intestine 100 may be urged further and further through the intestine 100 towards an end of the intestine 100. At the end of the program, energy transfer between the wireless energy transmitters T and receivers R is terminated so that the neural and muscle tissue of the intestine 100 may relax. Of course, the running of the program in the external controller C11 can be interrupted at any time by actuating the switch 14 once again, if desired.
More specifically, the internal controller C11 of each of the plurality of electrical stimulation devices 10 may be addressed individually by the external controller C11 (or by a remote controller as will be described hereinafter) using an individual code which is specific to the respective internal controller C11. In the situation as discussed above, where the electrical stimulation devices are to be actuated sequentially in order to stimulate the intestine in a wave-like manner, the respective electrical stimulation device may be addressed individually using the individual code of the corresponding internal controller C11. This way, only the electrical stimulation device 10 with the specifically addressed internal controller C11 may be activated by closing the associated switch 17 so that only this particular electrical stimulation device 10 receives electric energy through the wireless energy transmitter T for stimulating the respective section of the intestine 100. Accordingly, the wireless energy transmitter T may comprise a single primary coil extending over the entirety of the secondary coils in the wireless energy receivers R of all of the electrical stimulation devices 10.
Of course, the wireless energy receiver R in the first and second embodiments shown in
The primary coil 18 of the wireless energy transmitter T is shown in
Of course, the electrical stimulation devices 10 in the embodiments of
In the embodiments described above, energy is transmitted wirelessly to the energy storage unit E connected to the external controller C, and the external controller C11 is actuated by means of the switch 14, such as a press button. However, as already mentioned before and as shown in
Further alternatively, as shown in
In a preferred ninth embodiment, the external controller C11, either implanted or mounted to the patient's skin, is omitted and it is the wireless remote controller CR which controls the implanted wireless energy transmitter T, as is shown in
The systems for electrically stimulating tissue of a patient's intestine as described above may be combined with a mechanical or hydraulic constriction device as disclosed in WO 2011/128124 A1. Particularly suitable is the hydraulic constriction device as shown in
In this context.
Upon activation of the system by the patient using the subcutaneous actuator 14, emptying of the intestinal reservoir 140 is started by supplying hydraulic fluid from the artificial reservoir 193 to the first chamber 191. The next following chambers are supplied with the hydraulic fluid through the connections 192, thereby causing the hydraulically acting member 190 to be filled slowly from the first chamber 191 to the last chamber 194. The filling of the chambers occurs sequentially, with the next following chamber starting to fill before the previous chamber is filled completely. In this manner, intestinal contents are hydraulically squeezed out in the direction towards the exit of the reservoir 140. When the hydraulically acting member 190 is completely filled with hydraulic fluid, the reservoir 140 is completely constricted. The hydraulic fluid is then withdrawn from the chambers of the hydraulically acting member 190 back into the artificial reservoir 193 using negative pressure. The intestinal reservoir 140 may then start to fill up with intestinal contents again.
This process is controlled by the device 150, which is connected to the artificial reservoir 193. Connected to or integrally formed with the artificial reservoir 193 is an electrically driven pump (not shown) for pumping the hydraulic fluid into and withdrawing the hydraulic fluid from the hydraulically acting member. The electrically driven pump is supplied with energy from the combined energy storage means and control device 145. The combined energy storage means and control device 145 may further include the external controller CE and energy storage unit E mentioned above in relation to the electrical stimulation type system. Also, a wireless remote controller CR may be provided as described above.
In another embodiment, each chamber of the hydraulically acting member 190 may have a separate fluid connection to the artificial reservoir 193 in order to be able to be filled individually. The intestinal reservoir 140 may be emptied by consecutively filling two adjacent chambers of the hydraulically acting member 190, i.e. first filling the first and second chamber, then emptying the first chamber while filling the third chamber, then emptying the second chamber while filling the fourth chamber, and so forth. In this manner intestinal contents are squeezed towards and out of the exit of the intestinal reservoir 140.
Alternatively, instead of applying a negative pressure for evacuating the chambers, at least one valve, preferably two valves, may be provided (not shown) between the hydraulically acting member 190 and the artificial reservoir 193 which, when in an appropriate operational position, allows the hydraulic fluid to passively flow from the hydraulically acting member back into the artificial reservoir 193 when the intestinal reservoir 140 fills with intestinal contents and which, when in an appropriate other position, prevents the hydraulic fluid to flow from the hydraulically acting member back into the artificial reservoir when the intestinal reservoir is being emptied.
The wirelessly controllable electrical stimulation devices 10 as described above may likewise be implemented in valves for temporarily restricting or even closing an intestinal passageway with or without an additional constriction device, such as a hydraulic constriction device. In other words, a system as described above including a wirelessly controllable electrical stimulation device may be used in a valve, such as an artificial sphincter. Such valve or artificial sphincter may be used as an exit valve and/or as an entry valve of an intestinal reservoir, such as the reservoir made from the patient's intestine as described above or an artificial reservoir. This is further described in relation to an eleventh embodiment of a system for electrically stimulating tissue of the patient's intestine as shown in top view of
In addition to the electrical stimulation device 10, both the exit valve 40 and entry valve 30 may (or may not) comprise a hydraulic constriction device which may likewise be controlled by the external controller CE so as to coordinate electrical stimulation with hydraulic constriction. The hydraulic constriction device comprises a hollow hydraulic member 41 and 31, respectively, a hydraulic pump P and an energy storage unit E, which may be the same energy storage unit which supplies energy to the electrical stimulation devices 10. In particular, a single energy storage device E may be provided for the entire system. The hydraulic pump P is configured to pump a hydraulic fluid into and withdraw the hydraulic fluid from the interior of the hollow hydraulic members 41 and 31, respectively.
In those embodiments of the present disclosure where the system comprises a mechanical or hydraulic constriction device and where the system is configured to electrically stimulate, by means of one or more electrodes, the muscle or neural tissue in an area of the intestine constricted by the mechanical or hydraulic constriction device, such electrical stimulation may be limited to merely increase the blood flow through the tissue of the intestine without causing the intestine to contract or, if at all, contract only partly without completely restricting flow through the respective intestinal section. The purpose thereof is to exercise the tissue wall which is in contact with the constriction device, may it be mechanical or hydraulic. That is, the body tends to react to medical implants, 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, a mechanical or hydraulic or other type of constriction device may deprive the tissue cells of oxygen and nutrients which may lead to deterioration of the tissue, atrophy and eventually necrosis. This may result in migration of the device, including migration through the tissue wall. Exercising the tissue cells by stimulating blood flow increases the tolerance of the tissue for pressure from the implant. As stated, it is preferable to configure the system such that electrical stimulation of the muscle or neural tissue for increasing the blood flow through the tissue of the intestine is adjustable at a low level which is not enough to constrict the intestine.
In the step of placing the electrodes of the electrical stimulation devices in connection with the intestine, at least two of the electrodes of an electrical stimulation device are arranged on opposing sides of the patient's intestine.
The arrangement of the electrodes as described hereinafter may be implemented in any of the embodiments of the present disclosure, in particular also for the purpose of exercising a tissue wall of the intestine which is in contact with a constriction device, such as a mechanical or hydraulic constriction device. The human and animal 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. As mentioned, this may result in migration of the device, including migration through the tissue wall. 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 either be 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 makes up the muscular part of the walls of the digestive tract and ducts, including the intestinal tract.
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 carefully.
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 to 4 ms, the absolute refractory period is roughly 1 to 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 occurs 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 constriction device. Preferably, the electrical stimulation is provided by one or several electrode elements arranged on or in the tissue or at the interface or contact surface between an implantable constriction 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 to be stimulated so as to cause it to constrict or so as to cause it to exercise with no or little constriction, namely in situations where the tissue is affected, or risks to be affected, by mechanical forces exerted by a medical implant. Thus, the electrode element may be considered to be arranged between the medical implant, such as a constriction device, and the tissue against which the implant is arranged to rest, when implanted.
During operation of the electrical stimulation device, the electrical signal may cause the muscle cells to contract and relax repeatedly. If such activity is little, 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 to increase tolerance of the tissue for pressure and mechanical forces generated by the medical implant.
The interaction between the electrode or electrodes of the electrical stimulation device and the tissue of the patient's intestine 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 are 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 may also be referred to as a bare electrode. The interface between the electrode and the tissue may influence the behavior of the electrode since the electrical interaction with the tissue is transmitted via this interface. In the biological medium surrounding the electrode, 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 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 may be a bare electrode wherein the metal may be exposed to the surrounding biological medium when implanted in, or at, the muscle or neural tissue that is to be stimulated. In this case there may be a charge transfer at a metal-electrolyte interface between the electrode 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. 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 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 and the tissue when the electrode element is implanted. This allows for the electrical 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 tends 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 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 allows for a predominantly capacitive, or non-faradaic, transfer of the electrical 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. Examples 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.
It will be appreciated that both faradaic and capacitive mechanisms may be present at the same time, irrespective 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 electrical 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.
Although
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 Hz. 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 (ms), such as 0.1-20 milliseconds, 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 150, which may comprise one or several electrode elements 152, 154, such as a bare electrode or an electrode at least partly covered by a dielectric material 157 shown in
The electrode may be electrically connected to the energy source 160, 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 152, 154 may be integrated with or attached to the apparatus so that the electrode 152, 154 when implanted in the patient is arranged at the interface between the apparatus 100 and the muscle tissue. The electrode 152, 154 can thereby be used for exercising the muscle tissue that is mechanically affected by the implant.
The energy source 160 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 source 160 may be rechargeable by energy transmitted from outside the body, from an external energy source, or be replaced by surgery. Further, the electrode arrangement 150 may be operably connected to a stimulation controller 170, which may comprise an electrical pulse generator, for generating the electrical pulse. The stimulation controller 170 may be integrated with the energy source 160 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 150.
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 apparatus 100. 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 170. The stimulation controller 170 may use the received signal when controlling the energy source 160, such that the generated electrical signal amplifies the sensed action potentials.
The energy source 160 may preferably be an implantable energy source 160 configured to be placed on the inside of the patient's body. Preferably, the implantable energy source 160 may comprise a secondary cell, which can be charged from the outside of the body so as to reduce the need for surgical battery replacement procedures. As indicated in the present figure, the implantable energy source 160 may be configured to be supplied with electrical energy from an external energy source 165 arranged outside the body. In such an example, the system may further comprise an implantable charger 190 configured to be electrically connected to the implantable energy source 160 and to enable charging of the implantable energy source 160 by the external energy source 165. The implantable charger 190 may for example be configured to be electrically connected to the implantable energy source 160 by means of a wiring or a lead, such that the electrical energy may be transferred from the implantable charger 190 to the implantable energy source 160. The implantable charger 190 may further be coupled to the external energy source 165 by a wireless coupling or by a wired coupling, using a wiring or lead which may be similar to the one between the charger 190 and the implantable energy source 160. In case of the latter, the wiring or lead may terminate in a terminal which may be access via the skin of the patient, either as a contact port surfacing the skin or being arranged under the skin. Electrical energy may then be transmitted to the charger 190 by connecting the external energy source 165 to the port, for example by incising the skin to expose the port and making it possible for the external energy source 165 to be plugged in.
Alternatively, the implantable charger 190 may be configured to receive energy from the external energy source 165 wirelessly, such as for example inductively. In this case, the charger 190 may comprise an electromagnetic coil configured to receive the electrical power wirelessly from the external energy source 165. The charger 190 may for example be arranged subcutaneously so as to facilitate inductive transfer of the energy via the skin of the patient.
The charging of the implantable energy source 160 may be controlled according to several different schemes. In an example, the charging of the implantable energy source 160 may be controlled by controlling the receipt of electrical power, from the external energy source, at the implantable charger 190. Put differently, the charger 190 may be configured to vary or control its capability of receiving electrical energy from the external energy source 165.
Hence, the amount of electrical power delivered to the implantable energy source 160 may be regulated at the implantable charger 190 rather than at the external energy source 165, which hence may be allowed to transmit a substantially constant power. By varying the receipt at the charger 190, rather than the transmission at the external power source 165, the charging of the implantable energy source 160 may be performed without sending control signals to the external energy source 165. Instead, the intelligence required for regulating and controlling the charging of the implanted energy source 160 may be accommodated within the body of the patient, without the need of communication with the outside of the body.
In an alternative embodiment, the charging of the implantable energy source 160 may be controlled by controlling the transmission of electrical power at the external energy source 165. Thus, the charger 190 (or any other component of the apparatus/system arranged in the body) may send transmission instructions, for example via a control signal, to the external energy source 165 which may regulate its transmitting power accordingly.
The charging of the implantable energy source 160 may be controlled by the controller 170, which hence may be configured to issue control instructions to the implantable charger 190 and/or the external energy source 165, as discussed above. In some examples, the controller 170 may be configured to indicate a functional status of the implantable energy source 160, such as for example charge level, charging capacity, voltage and/or temperature of the implantable energy source 160. The functional status may for example be used for controlling the charging of the implantable energy source 160 as described above, and for indicating the status of the implantable energy source 160 to the patient or another, external entity such as medical staff. The functional status may for example be transmitted to the outside of the body, where it can be interpreted and used for diagnosis of the status/condition of the implanted apparatus. Further, the functional status may be transmitted to the outside of the body to provide a warning signal, for example indicating low battery or overheating. The transmission of a signal to/from the controller 170 is described in further detail in connection with the following
The functional status may for example be based on a signal from a sensor, such as a temperature sensor configured to sense a temperature of the implanted energy source 160, or a current or voltage meter configured to measure an electrical condition of the implanted energy source 160. The sensor output may be transmitted to the controller 170, for example by means of a wiring or electrical conductor, where it can be processed and acted upon in the form of an issued signal comprising control instructions for the charger 190/external energy source 165 and/or functional status information.
The functional status may in some examples be transmitted via a carrier signal to the outside of the body by means of a transmitter, which for example may be arranged subcutaneously. In some example the transmitter may be integrated in the charger 190.
The signal, by which the external signal transmitter 175 is communicating with the implanted controller 170, may be selected from the group consisting of: a sound signal, an ultrasound signal, an electromagnetic signal, and infrared signal, a visible light signal, an ultra violet light signal, a laser signal, a microwave signal, a radio wave signal, an X-ray radiation signal and a gamma radiation signal.
While illustrated as separate components/entities in the figure, it is appreciated that the implanted, or internal, controller 170 may be integrated in the implantable charger 190 and/or in the implantable energy source 160. Further, the external signal transmitter 175 may be integrated in the wireless remote.
The implantable controller 170, which also may be referred to as an internal controller or a stimulation controller 170, may be understood as any implantable unit capable of controlling the electrical stimulation of the tissue. A controller could include an electrical signal generator, a modulator or other electrical circuitry capable of delivering the electrical stimulation signal to the electrode arrangement. Further, the controller may be capable of processing control signals and generate the electrical stimulation signal in response thereto, and further to generate control signals for the control of other components of the system or apparatus, such as for example the implanted energy source 160 and/or the implantable charger 190. A control signal may thus be understood as any signal capable of carrying information and/or electric power such that a component of the system/apparatus can be directly or indirectly controlled.
The controller may comprise a processing unit, such as a CPU, for handling the control of the electrode arrangement 150 and other components of the system. The processing unit could be 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 processing unit may also comprise memory for storing instruction and/or data. The controller 170 could be adapted to keep track of different stimulation patterns and periods used for the stimulation of the muscle tissue, and in some examples also the action potentials sensed by the sensor S1. The controller 170 may further comprise a communicator, or communication unit 171 as outlined above, which may be configured for receiving and/or transmitting wireless or wired signals to/from outside the body. The communication unit 171 can enable programming the controller 170 form outside of body of the patient such that the operation of the electrode arrangement 150 can be programmed to function optimally.
The controller 170, as well as other implanted components such as the energy source 160 and the charger 190, may be enclosed by an enclosure so as to protect the components 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 R, 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 hindered.
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 keys results 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 on 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 key's 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 an e-ID which is downloaded from a website 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. an SMS, or an 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 communicates 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 be subject of the communication and comprise sensitive information, 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. Furthermore, data comprising operating instructions may be subject of the communication and comprise other sensitive information, for example a new or updated control program, parameters relating to specific configurations of the implant, etc. Such data may for example comprise instructions on how to operate the electrical stimulation device and/or implantable constriction device, instructions to collect patient data, instructions to transmit feedback, etc. These parameters and data must be protected from being compromised.
A controller for controlling the implantable medical device according to any of the embodiments disclosed herein and for communicating with devices external to the body of the patient and/or implantable sensors will now be described in a general way with reference to
Referring now to
The second control program 312 is the program controlling the implantable medical device M in normal circumstances, providing the implantable medical device M 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 via 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 may 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 may 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 may 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 may be performed by utilizing a magnetic sensor and applying a magnetic force from outside the body. The reset function 316 may be configured such that it responds only to magnetic forces applied for a duration of time exceeding a limit, such as 2 seconds. The time limit may equally plausible be 5 or 10 seconds, or longer. In these cases, the implant may 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 medical device M, 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 not having 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, 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 sometime 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 WL1. 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 controller 300 of the implantable medical device M according to
As seen in
The controller 300 of the implantable medical device M according to
The switch 309 may 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 of the implantable medical device M.
The external device 320 is represented in
The second, third or fourth communication method 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 or 5G.
The external device 320 may be adapted to be in electrical connection C1 with the implantable medical device M, 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 medical device M.
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 medical device M 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 may for example be a license number of the implant or a chip number of the implantable medical device M. 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 medical device M. The altering of an operation of the implantable medical device M 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 medical device M using operation instructions in the decrypted data.
Methods for encrypted communication between an external device 320 and the controller 300 may comprise:
As described above, further keys may be necessary to decrypt the data. Consequently, the wireless transceiver 328 is configured for:
wherein the computing unit 326 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 hereinafter, 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 to or knowledge of the physiological parameters of the patient which it is based on, providing an extra level of security to the generated keys.
A method of communication between an external device 320 and an implantable medical device M 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 hereinafter. In these cases, the implant and/or external device(s) comprise 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 controller 300 of the implanted medical device M may comprise a first transceiver 303 configured to be in electrical connection C1 with the external device 320, using the body as a conductor. Alternatively, the first transceiver 303 of the controller 300 may be wireless. The external device 320 may comprise a first external transmitter 323 configured to be in electrical connection C1 with the implanted medical device M, using the body as a conductor, and a wireless transmitter configured to transmit wireless communication WL1 to the controller 300. Alternatively, the first external transmitter 323 of the external device 320 may be wireless. The first external transmitter 323 and the wireless transmitter of the external device 320 may be the same or separate transmitters.
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 transceivers 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 medical device M. For example, a control program 310 running in the controller 300 may be updated or 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 which may comprise 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 then derives 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 via 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 via WL2 from the 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 medical device M as described above.
The second external device 330 may be controlled by, for example, a care person 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 medical device M. 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) comprise(s) 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 via 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 by 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 via WL1, received 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 via 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 or a server or 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 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 implant. In these cases, the implant and/or external device(s) comprise(s) 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 321, 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.
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, a device configured to draw blood, etc. The authentication input may thus comprise a code or anything 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 321 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 the 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 medical device M based on received conductive communication and/or updating a control program running in the controller 300 as described above.
The controller 300 is further configured for receiving input authentication data from the external device 320. Authentication data related to the sensation generated may be 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 1 s. 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 the implantable medical device M and the external device 320 accordingly includes the following steps.
Generating, by the 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 infrared pulse), a light signal (e.g. a visual light pulse), an electrical 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.
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 engaging an electrical switch, using a biometric input sensor or entering the input into a 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 medical device M 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 the step was performed, the analysis may be performed by the implantable medical device M.
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 medical device M.
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.
According to one embodiment described with reference to
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The physical parameter of the implanted medical device MD could comprise at least one of a current setting or value of the implanted medical device MD, a prior instruction sent to the implanted medical device MD or an ID of the implanted medical device MD.
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 medical device MD 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.
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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 RFIDtype 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 remote control 320″ which can be used by the implanted medical device MD as a way to establish that the external device 320 is at a position which the implanted medical device MD and/or the patient can acknowledge as being correct, e.g. in the direct proximity to the medical device MD and/or the patient, such as within reach of the patient and/or within 1 or 2 meters of the implanted medical device MD. 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 implantable medical device MD 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 medical device MD. 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
Plurality of External Devices with Different Levels of Authority for Increased Security
Starting from the lowest level of authority, the remote control 320″ comprises a wireless transceiver 328 for communicating with the implanted medical device MD. The remote control 320″ is capable of controlling the operation of the implanted medical device MD via the controller 300, by controlling pre-set functions of the implantable medical device MD, e.g. for operating an active portion of the implanted medical device MD for performing the intended function of the implanted medical device MD. 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 and/or 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 to 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 with 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.
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 can take place using BT. The UWB signal can 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 MD 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 MD is hacked by means of BT communication. In embodiments in which a BT/UWB combination is used, the UWB connection may be used also for the transmission of data. In the alternative, the UWB connection can 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 control logic which runs a control logic application for communicating with the implanted medical device MD. The control logic can receive input directly from control buttons 335 arranged on the remote control 320″ or from a control interface 334i displayed on a 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 a display device 334 operated by the patient, the remote control 320″ transmits the control interface 334i in the form of a web-view, i.e. a remote interface that runs in a sandbox environment on the patient's display device 334. The patient's display device 334 can be, for example, a mobile phone, a tablet or a smart watch. In the embodiment shown in
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 can 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 can add an extra layer of encryption before transmitting the control commands to the remote control 320″ or can simply act as a router for relaying the control commands from the patient's display device 334 to the remote control 320″. It is also possible that the DDI 330 adds a layer of end-to-end encryption directed at the implanted medical device MD, such that only the implanted medical device MD can decrypt the control commands to perform the command intended by the patient.
The patient's display device 334 can have a first and second application related to the implanted medical device MD. The first application is the control application displaying the control interface 334i for controlling the implanted medical device MD, whereas the second application is a general application for providing the patient with general information about the status of the implanted medical device MD 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 well-being of the patient, lifestyle of the patient or general input from the patient concerning the function of the implanted medical device MD. The second application does not provide input to the remote control 320″ and/or the implanted medical device MD, thus handles data which are less sensitive. As such, the general application can 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 MD can require that the auxiliary radio connections are temporarily de-activated. It is also possible 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 can require the temporary de-activation of auxiliary radio connections. In the embodiment shown in
In the embodiments in which the patient's display device 334 is configured to display and interact only with a web-view provided by another unit of the system, it is possible that the web-view 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.
Turning now to the P-EID 320″ “, the P-EID 320” is an external device which communicates with, and charges, the implanted medical device MD. The P-EID 320″ can be remotely controlled by the HCP to read information from the implanted medical device MD, control the operation of the implanted medical device MD, control the charging of the implanted medical device MD, and adjust the settings to the software running on the controller 300 of the implanted medical device MD, e.g. by adding or removing pre-defined program steps and/or by the selection of pre-defined parameters within a limited range. Just as the remote control 320″, the P-EID 320″” can be configured to communicate with the implanted medical device MD using BT or UWB communication. Just as with the remote control 320″, it is also possible 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 MD 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 MD. 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 can 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, in the form of a magnetic field, to a wireless receiver 395 of the implanted medical device MD configured to receive the energy in the form of a 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 MD (such as the operation device, controller 300, etc.). The magnetic field generated in the P-EID and received in the implanted medical device MD is denoted a “charging signal”. In addition to enabling the wireless transfer of energy from the P-EID to the implanted medical device MD, the charging signal may also function as a means of communication. For instance, variations in the frequency of the transmission and/or amplitude of the signal may be used as a signaling means for enabling communication in one direction, from the P-EID to the implanted medical device MD, or in both directions between the P-EID and the implanted medical device MD. The charging signal in the embodiment shown in
Just as for the remote control 320″, the UWB signal can 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 MD 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 MD is hacked by means of BT communication. In the alternative, the charging signal can be used as a wake-up 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 can be assessed by the controller 300 in the implanted medical device MD 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 can 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 unlocking encrypted communication sent by BT.
UWB can also be used for waking up the charging signal transmission, starting the wireless transfer of energy or 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. The communication from the HCP to the implanted medical device MD 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 which merely passes on encrypted communication from the HCP to the controller 300 of the implanted medical device MD. This solution further increases security as the key for decrypting the information rests only with the HCP and with the implanted medical device MD, which reduces the risk that an unencrypted signal is intercepted by an unauthorized device.
When the implanted medical device MD is to be controlled and/or updated remotely by the HCP via the P-EID 320″ “, an 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 altering the order in which pre-defined program steps are to be executed. The instructions/parameters put into the HCP DD 332 for remote operation is, in the embodiment shown in
The Health Care Provider EID (HCP EID) 320′ has the same features as the P-EID 320″ and can communicate with the implanted medical device MD 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 re-program the controller 300 of the implanted medical device MD, including replacing the entire program code running in the controller 300. The idea is that the HCP EID 320′ always remains with the HCP and, as such, all updates to the program code or retrieval of data from the implanted medical device MD using the HCP EID 320′ is performed with the HCP being 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 MD.
In the embodiment shown in
In the embodiment shown in
The patient's key 333′ in the embodiment shown in
The HCP's key 333″ in the embodiment shown in
In alternative embodiments, it is however possible 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).
In the embodiment shown in
In addition to acting as an intermediary or router for communication, the DDI 330 collects data of the implanted medical device MD, of the treatment and of the patient. The data may be collected in an encrypted, anonymized or 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 shown in
The wireless connections specifically described in the embodiment shown in
Although wireless transfer is primarily described in the embodiment disclosed with reference to
As have been discussed before in this application, communication with a medical implant needs to be reliable and secure. For this purpose, it is desirable to have a standalone device as an external remote control (for example described as 320″ in
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
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In the embodiment shown in
The coating 530 may comprise at least one layer of a biomaterial. The coating 530 may comprise a material that is antithrombotic. The coating 530 may also comprise a material that is antibacterial. The coating 530 may be attached chemically to the surface 520.
The coatings referred to may comprise any substance or any combination of substances. The coatings may comprise anticoagulant medicaments, such as: Apixaban, Dabigatran, Dalteparin, Edoxaban, Enoxaparin, Fondaparinux, Heparin, Rivaroxaban, and Warfarin.
The coatings may also comprise medicines or substances that are so-called antiplatelets. These may include Aspiring. Cilostazol, Clopidogrel, Dipyridamole, Eptifibatide, Prasugrel, Ticagrelor, Tirofiban, Vorapaxar.
The coatings may also comprise any other type of substance with antithrombotic, antiplatelet or antibacterial features, such as sortase A, perfluorocarbon and more.
The coatings 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 outer surface of the implant is made of such a metal, this may be advantageous in order to reduce bacterial infections. The medical implant or the surface of the implant may be made 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 local and 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 arranged to slowly release 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 micro pattern may, for example, be etched into the surface of the implantable medical device prior to insertion into the body. The surface of the implantable medical device 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.
The medical device MD comprises a first portion MD′ configured to be placed on a first side 612 of the tissue portion 610, the first portion MD having a first cross-sectional area A1 in a first plane P1 and comprising a first surface 614 configured to face a first tissue surface 616 of the first side 612 of the tissue portion 610. The medical device MD further comprises a second portion MD″ 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 MD″ having a second cross-sectional area A2 in a second plane P2 and comprising a second surface 620 configured to engage a second tissue surface 622 on the second side 618 of the tissue portion 610. The medical device MD further comprises a connecting portion MD-2 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 MD-2 here has a third cross-sectional area A3 in a third plane P3 and a fourth cross-sectional area A4 in a fourth plane P4 and a third surface 624 configured to engage the first tissue surface 616 of the first side 612 of the tissue portion 610. The connecting portion MD-2 is configured to connect the first portion MD′ to the second portion MD″.
The connecting portion MD-2 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 MD-2 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 MD″ 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 MD-2 may cooperate with the second portion MD″ to keep the medical device MD in place in the hole of the tissue portion 610.
In the embodiment illustrated in
The medical device MD is configured such that, when implanted, the first portion MD′ will be placed closer to the outside of the patient than the second portion MD″. Furthermore, in some implantation procedures the medical device MD may be implanted such that space will be available beyond the second portion MD″, i.e. beyond the second side 618 of the tissue portion 610, whereas there may 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 MD′ towards the tissue portion 610 and provide that the second portion MD″ does not travel through the hole in the tissue portion 610 towards the first side 612 of the tissue portion 610. Thus, it is preferable if the medical device MD is primarily configured to prevent the first portion MD′ from traveling through the hole in the tissue portion 610 towards the second side 618 of the tissue portion 610.
The first portion MD′ may further comprise one or several connections 605 for transferring energy and/or communication signals to the second portion MD″ via the connecting portion MD-2. The connections 605 in the illustrated embodiment are symmetrically arranged around a circumference of a protrusion 607 of the first portion MD′ and are arranged to engage with a corresponding connection 609 arranged at an inner surface of the connecting portion MD-2. The protrusion 607 may extend in a central extension C1 of the central portion MD-2. The second portion MD″ may also comprise one or several connections 611, which may be similarly arranged and configured as the connections 605 of the first portion MD′. For example, the one or several connections 611 may engage with the connection 609 of the connecting portion MD-2 to receive energy and/or communication signals from the first portion MD′. 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 MD″, wherein the connections are arranged to engage with corresponding connections arranged on the opposing surface 613 of the connecting portion MD-2. 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 MD′, connecting portion MD-2 and second portion MD″ 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 MD′, the second surface 620 of the second portion MD′, the third surface 624 of the connecting portion MD-2, and an opposing surface 613 of the connecting portion MD-2, may be provided with at least one of ribs, barbs, hooks, a friction-enhancing surface treatment, and a friction-enhancing material, to facilitate the medical device MD being held in position by the tissue portion and/or to facilitate that the different parts of the medical device MD are held in mutual position.
The opposing surface 613 may be provided with a recess configured to house at least part of the first portion MD′. In particular, such recess may be configured to receive at least a portion of the first portion MD′, 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 MD-2. In particular, such recess may be configured to receive at least a portion of the connecting portion MD-2, 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 MD′ 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 lifetime 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 MD″ may further comprise a controller 300b comprising one or several processing units.
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 medical device MD. 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 MD-2 illustrated in
The connecting portion MD-2 is not restricted to flanges, however. Other protruding elements may additionally or alternatively be incorporated into the connecting portion MD-2. As such, the connecting portion MD-2 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 traveling through the hole in the tissue portion 610 such that the second portion MD″ and the connecting portion MD-2 can be held in position by the tissue portion 610 of the patient even if the first portion MD′ is disconnected from the connecting portion MD-2. 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 MD-2. As such, the at least one protruding element will also comprise the third surface 624 configured to engage the first tissue surface 616 of the first side 612 of the tissue portion 610.
The connecting portion MD-2 may comprise a hollow portion 628. The hollow portion 628 may provide a passage between the first and second portions MD′, MD″. In particular, the hollow portion 628 may house a conduit for transferring fluid from the first portion MD′ to the second portion MD″. 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 MD′ and the second portion MD″.
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.
Some relative dimensions of the medical device MD will now be described with reference to
The height H1 of the first portion MD′ in a direction perpendicular to the first plane P1 may be less than a height H2 of the second portion MD″ in said direction, such as less than half of said height H2 of the second portion MD″ in said direction, less than a quarter of said height H2 of the second portion MD″ in said direction, or less than a tenth of said height H2 of the second portion MD″ in said direction.
The at least one protruding element 626 may have a diameter DF in the fourth plane P4 being one of: less than a diameter D1 of the first portion MD′ in the first plane P1, equal to a diameter D1 of the first portion MD′ in the first plane P1, and larger than a diameter D1 of the first portion MD′ in the first plane P1. Similarly, the cross-sectional area of the at least one protruding element 626 in the fourth plane P4 may be less, equal to, or larger than a cross-sectional area of the first portion in the first plane P1.
The at least one protruding element 626 may have a height HF in a direction perpendicular to the fourth plane P4 being less than a height HC of the connecting portion MD-2 in said direction. Here, the height HC of the connecting portion MD-2 is defined as the height excluding the at least one protruding element, which forms part of the connecting portion MD-2. The height HF may alternatively be less than half of said height HC of the connecting portion MD-2 in said direction, less than a quarter of said height HC of the connecting portion MD-2 in said direction, or less than a tenth of said height HC of the connecting portion MD-2 in said direction.
As shown in
Wireless energy receivers and/or communication receivers and/or transmitters in the first portion MD′ 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 MD′ 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 MD′ and second portion MD″ may be made using VLF signals. In such embodiments, receivers and transmitters (for energy and/or communication) of the first portion MD′ and second portion MD″ are configured accordingly.
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 MD-2, as shown in
Although one type or embodiment of the implantable energized medical device MD, 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 MD or portions MD′, MD″ to be assembled into implantable energized medical devices MD. 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 MD 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 MD may thus be said to be modular, in that the first portion MD′, the second portion MD″, and/or the connecting portion MD-2 may be interchanged for another type of the respective portion.
With reference to
Accordingly, the group 652 of one or more connecting portions MD-2 comprises three different types of connecting portions MD-2. Here, the different types of connecting portions MD-2 comprise connecting portions MD-2a, MD-2b, MD-2c having different heights. Furthermore, the group 654 of one or more second portions MD″ comprises two different types of second portions MD″.
Here, the different types of second portions MD″ comprise a second portion MD″ a being configured to eccentrically 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 MD″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 medical device MD 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 MD″ comprise a second portion MD″b being configured to eccentrically 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 MD″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 medical device MD 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 MD may be modular, and different types of medical devices MD can be achieved by selecting and combining a first portion MD′, a connecting portion MD-2, and a second portion MD″, from each of the groups 652, 654, 656.
In the illustrated example, a first implantable energized medical device MDa is achieved by a selection of the first portion MD′, the connecting portion MD-2a, and the second portion MD″a. Such device MDa may be particularly advantageous in that the connecting portion MD-2a may be able to extend through a thick layer of tissue to connect the first portion MD′ and the second portion MD″a. Another implantable energized medical device MDb is achieved by a selection of the first portion MD′, the connecting portion MD-2S, and the second portion MD″b. Such device may be particularly advantageous in that the connecting portion MD-2c has a smaller footprint than the connecting portion MD-2a, i.e. occupying less space in the patient. Owing to the modular property of the medical devices MDa and MDb, a practician or surgeon may select a suitable connecting portion as needed upon having assessed the anatomy of a patient. Furthermore, since devices MDa and MDb share a common type of first portions MD′, it will not be necessary for a practitioner or surgeon to maintain a stock of different first portions MD′ (or a stock of complete, assembled medical devices MD) merely for the sake of achieving a medical device MD having different connections located in the first end or second end of the second portion MD″ respectively, as in the case of second portions MD″a. MD″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 MD′ and second portion MD″, 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 MD′ close to the connecting portion MD-2 and the second portion MD″. Such placement may provide that energy and/or communication signals transmitted by the unit 308c will not be attenuated by internal components of the first portion MD′ when being transmitted to the second portion MD″. Such internal components may include a first energy storage unit 304a.
The first portion MD′ 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 to 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, 308c 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, 308b, 308c for communicating wirelessly with an external device.
The first controller may be connected to a first wireless communication receiver 308a. 308c in the first portion MD′ for receiving wireless communication from an external device and/or from a wireless communication transmitter 308b in the second portion MD″. Furthermore, the first controller may be connected to a first wireless communication transmitter 308a, 308c in the first portion MD′ for transmitting wireless communication to a second wireless communication receiver 308b in the second portion MD″. The second controller may be connected to the second wireless communication receiver 308b for receiving wireless communication from the first portion MD′. The second controller may further be connected to a second wireless communication transmitter 308b for transmitting wireless communication to the first portion MD″.
In some embodiments, the first wireless energy receiver 308a comprises a first coil, and the wireless energy transmitter 308a, 308c comprises a second coil.
Pop rivet shoe
With reference to
The first portion MD′ has an elongated shape in the illustrated embodiment of
As illustrated in
Similarly, a connecting interface between the connecting portion MD-2 and the first portion MD′ may be eccentric with respect to the first portion MD′ in the first direction 631 and/or in the second direction 633.
The first portion MD′, connecting portion MD-2 and second portion MD″ may structurally form one integral unit. It is, however, also possible that the first portion MD′ and the connecting portion MD-2 structurally form one integral unit while the second portion MD″ forms a separate unit, or that the second portion MD″ and the connecting portion MD-2 structurally form one integral unit while the first portion MD′ forms a separate unit.
Additionally, or alternatively, the second portion MD″ may comprise a removable and/or interchangeable portion 639. In some embodiments, the removable portion 639 may form part of a distal region. A removable portion may also form part of a proximal region. Thus, the second portion MD″ may comprise at least two removable portions, each being arranged at a respective end of the second portion MD″. The removable portion 639 may house, hold or comprise one or several functional parts of the medical device MD, such as gears, motors, connections, reservoirs, and the like as described in other parts of the present disclosure. An embodiment having such a removable portion 639 will be able to be modified as necessary to circumstances of a particular patient.
In the case of the first portion MD″, connecting portion MD-2 and second portion MD″ structurally forming one integral unit, the eccentric connecting interface between the connecting portion MD-2 and the second portion MD″, with respect to the second portion MD″, will provide that the medical device MD will be able to be inserted into the hole in the tissue portion. The medical device MD 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 MD″ to pass through the hole, before it is angled, rotated and/or pivoted to allow any remaining portion of the second portion MD″ to pass through the hole and allow the medical device MD to assume its intended position.
As illustrated in
With reference to
The second portion MD″ may be curved along its length. For example, one or both ends of the second portion MD″ 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 MD″ curves within the second plane P2, exclusively or in combination with curving in other planes. The second portion MD″ 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 MD″ may respectively comprise an elliptical point. 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 MD′ may have such features.
The second portion MD″ 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 MD″ will be described. It is, however, to be understood that these features and properties may also apply to the first portion MD′.
The second portion MD″ 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 MD-2 and the second portion MD″, the intermediate region 638 is defined by the connecting interface 630 between the connecting portion MD-2 and the second portion MD″, and the distal region 640 extends from the connecting interface 630 between the connecting portion MD-2 and the second portion MD″ 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) are present in the second portion MD″.
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 MD″ is defined as x, and the width of the second portion MD″ 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 MD-2 and the second portion MD″ 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 MD″ along said length and width directions. In other words, the connecting interface between the connecting portion MD-2 and the second portion MD″ is eccentric in at least one direction with respect to the second portion MD″ such that a heel and a toe are formed in the second portion MD″.
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 MD′ may comprise a substantially flat side facing towards the tissue portion 610. Furthermore, an opposing surface of the first portion MD′, 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 MD″ may comprise a substantially flat side facing towards the tissue portion 610. Furthermore, an opposing surface of the second portion MD″, facing away from the tissue portion 610, may be substantially flat.
The second portion MD″ may be tapered from the first end 632 to the second end 634, thus giving the second portion MD″ different heights and/or widths along the length of the second portion MD″. 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 MD″.
Some dimensions of the first portion MD′, the second portion MD″ and the connecting portion MD-2 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 MD′ may have a maximum dimension 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 MD′ may have a diameter 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 MD-2 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 MD″ may have a maximum dimension 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 greater 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 are also possible. The length 642 of the proximal region 636 may be smaller than, equal to, or greater 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 MD″, 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 MD″, such as less than a fourth, less than a fifth, or less than a tenth of the length of the second portion MD″.
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 medical device MD is implanted. As illustrated in
The different orientations of the second portion MD″ relative to the first portion MD′ may be defined as the length direction of the second portion MD″ having a relation or angle with respect to a length direction of the first portion MD′. Such angle may be 15, 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 MD′ and the second portion MD″ 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 medical device MD is implanted. In the embodiment illustrated in
The second end 634 of the second portion MD″ 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 MD in the patient. Hereby, when the medical device MD 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 MD″ 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 MD″ may comprise one or several connections for connecting to an implant which is located in a cranial direction from a location of the implantable energized medical device MD in the patient. Hereby, when the medical device MD 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 MD″ 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.
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 MD′ 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 MD′ and second portion MD″ 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 medical device MD is positioned such that the second portion MD″ 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 portion MD″ through the hole 611 may be facilitated. Furthermore, if the first portion MD′ is then displaced in relation to the second portion MD″ such that the first cross-sectional distance CD1a of the first portion MD′ is displaced in relation to a length extension of the hole 611, the first portion MD′ may be prevented from traveling 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 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 MD may be capable of assuming several different arrangements with regard to a rotational displacement of the first portion MD′ and second portion MD″. In particular, this is possible when the first portion MD′ and/or the second portion MD″ is configured to detachably connect to the interconnecting portion MD-2. For example, a connection mechanism between the first portion MD′ and the connecting portion MD-2, or between the second portion MD″ and the connecting portion MD-2, may possess a rotational symmetry to allow the first portion MD′ to be set in different positions in relation to the connecting portion MD-2 and in extension also in relation to the second portion MD″. Likewise, such rotational symmetry may allow the second portion MD-2″ to be set in different positions in relation to the connecting portion MD-2 and in extension also in relation to the first portion MD″.
With reference to
With reference to
The medical device MD is configured to be held in position by a tissue portion 610 of a patient. The medical device MD comprises a first portion MD′ configured to be placed on a first side 612 of the tissue portion 610, the first portion MD′ having a first cross-sectional area in a first plane P1 and comprising a first surface 614 configured to face and/or engage a first tissue surface of the first side 612 of the tissue portion 610. The medical device MD further comprises a second portion MD″ 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 MD″ having a second cross-sectional area in a second plane and comprising a second surface 620 configured to engage a second tissue surface of the second side 618 of the tissue portion 610. The medical device MD further comprises a connecting portion MD-2 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. Here, the connecting portion MD-2 has a third cross-sectional area in a third plane. The connecting portion MD-2 is configured to connect the first portion MD′ to the second portion MD″.
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 MD′ comprises a first coil 658 and a second coil 660, and the second portion MD″ 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 MD′ may comprise a first wireless energy receiver configured to receive energy transmitted wirelessly from an external wireless energy transmitter, and further the first portion MD′ may comprise a first wireless communication receiver. The first wireless energy receiver and the first wireless communication receiver may comprise the first coil 658. Accordingly, the first coil 658 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 MD′ comprises a distal end 665 and a proximal end 666, here defined with respect to the connecting portion MD-2. In particular, the proximal end 665 is arranged closer to the connecting portion MD-2 and closer to the second portion MD″ when the medical device MD is assembled. In the illustrated embodiment, the first coil 658 is arranged at the distal end 665.
The first portion MD′ 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 comprise(s) 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. Here, the second coil 660 is arranged at the proximal end 665 of the first portion MD′. Such placement of the second coil 660 may provide that energy and/or communication signals transmitted by the second coil 660 will not be attenuated by internal components of the first portion MD′ when being transmitted to the second portion MD″.
In some embodiments, the first wireless energy receiver and the internal wireless energy transmitter comprise 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 MD″ 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 MD″ comprises the second wireless energy receiver and/or the second wireless communication receiver.
The second portion MD″ comprises a distal end 668 and a proximal end 670, here defined with respect to the connecting portion MD-2. In particular, the proximal end 668 is arranged closer to the connecting portion MD-2 and closer to the first portion MD′ when the medical device MD is assembled. In the illustrated embodiment, the third coil 662 is arranged at the proximal end 668 of the second portion MD″. Such placement of the third coil 662 may provide that energy and/or communication signals received by the third coil 662 will not be attenuated by internal components of the second portion MD″ when being received from the first portion MD′.
The first portion MD′ may comprise a first controller 300a connected to the first coil 658, second coil 660 and/or third coil 662. The second portion MD″ 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 MD′ 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 to 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 to 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 to be charged faster than the second energy storage unit 304b. Herein, 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.
Pop rivet gear
The housing 484 of the medical device MD or second portion MD″ may be present in some embodiments of the medical device MD. 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. Herein, 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 R, 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 medical device MD, 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 medical device MD. However, in some embodiments the second portion MD″ comprises several chambers being hermetically sealed from each other. Such chambers may be coupled via the magnetic coupling as discussed herein. The magnetic coupling 490a, 490b provides for that mechanical work output by the medical device MD via, e.g., an electric motor can be transferred from the medical device MD to, e.g., an implant 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
With reference to
The device MD is configured to be held in position by a tissue portion 610 of a patient. The device MD comprises a first portion MD′ configured to be placed on a first side 612 of the tissue portion 610, the first portion MD′ 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 MD further comprises a second portion MD″ 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 MD″ 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 MD further comprises a connecting portion MD-2 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 MD-2 here has a third cross-sectional area in a third plane. The connecting portion MD-2 is configured to connect the first portion MD′ to the second portion MD″. In the illustrated embodiment, a connecting interface 630 between the connecting portion MD-2 and the second portion MD″ is arranged at an end of the second portion MD″.
The first portion MD′ may have an elongated shape. Similarly, the second portion MD″ may have an elongated shape. However, the first portion MD′ and/or second portion MD″ 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 MD′, connecting portion MD-2 and second portion MD″ may structurally form one integral unit. It is however also possible that the first portion MD′ and the connecting portion MD-2 structurally form one integral unit, while the second portion MD″ form a separate unit, or, that the second portion MD″ and the connecting portion MD-2 structurally form one integral unit, while the first portion MD′ form a separate unit.
Additionally, or alternatively, the second portion MD″ 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 MD″ will be described. It is however to be understood that these features and properties may also apply to the first portion MD′.
The second portion MD″ 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 MD-2 and the second portion MD″, and the distal region 640 extends from the connecting interface 630 between the connecting portion MD-2 and the second portion MD″ 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 MD′ may comprise a substantially flat side facing towards the tissue portion 610. Furthermore, an opposing surface of the first portion MD′, 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 MD″ may comprise a substantially flat side facing towards the tissue portion 610. Furthermore, an opposing surface of the second portion MD″, facing away from the tissue portion 610, may be substantially flat.
The second portion MD″ may be tapered from the first end 632 to the second end 634, thus giving the second portion MD″ different heights and/or widths along the length of the second portion MD″. 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 MD″.
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 MD″ having rotational symmetry along the first direction 631, as illustrated for example in
As illustrated in
Referring now to
Further Aspect Combinable with any One of the Other Aspects-Communication
| Number | Date | Country | Kind |
|---|---|---|---|
| PCT/EP2021/073893 | Aug 2021 | WO | international |
| 2250189-4 | Feb 2022 | SE | national |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/EP2022/073860 | 8/26/2022 | WO |
