The present application is a Section National Stage Application of International Application No. PCT/CN2014/088615, filed on Oct. 15, 2014, which claims priority to Chinese patent application No. 201410446153.9, filed on Sep. 3, 2014, and entitled “DISPOSABLE TUBELESS FLUID DELIVERY SYSTEM”, the entire disclosure of which is incorporated herein by reference.
The present disclosure generally relates to the field of medical appliance, and more particularly, to a disposable tubeless fluid delivery system configured to continuously infuse deliver therapeutic liquids into a patient.
A fluid delivery device is a medical appliance which can achieve patient disease treatment by continuously delivering a fluid into the patient. The fluid delivery device is widely used in the treatment of diabetes. The fluid delivery device continuously delivers insulin to a subcutaneous tissue of a patient based on a dosage required by the patient, so as to simulate the secretion function of the pancreas and stabilize glucose of the patient. The fluid is usually stored in a pump base, and a conventional fluid delivery device usually delivers the fluid into a patient via a catheter connected to the pump base. The catheter, when it is used, is not only an obstruction for the patient's activities, but also not beautiful.
In order to overcome the above-mentioned shortcomings of the conventional fluid delivery device, a tubeless fluid delivery device has been developed, which has a pump base stuck to the patient's body by a medicine adhesive plaster, and an indwelling cannula implanted in a subcutaneous tissue of the patient to deliver a fluid. The tubeless fluid delivery device integrates the pump base and a control module in a box, and remotely control and administrate drug delivery by a wireless handheld device. However, the patient is required to wear the pump base and carry the wireless handheld device, at the same time, when the patient is being treated by the existing tubeless fluid delivery device. The existing tubeless fluid delivery device has some shortages such as radio interference and high costs. Moreover, the existing tubeless fluid delivery device has some shortcomings of complicated operation, large size, large mass, and inconvenient wearing.
A normal pancreas may automatically monitor the changes of glucose, and may automatically secrete insulin required. “Real time dynamic glucose monitoring system” indicates a device that can real-timely and dynamically monitor the changes of glucose by using a glucose sensor implanted in the subcutaneous tissue of a patient. Considering the comfort level of patients when they are wearing these components, the indwelling cannula implanted in a subcutaneous tissue of a patient and the glucose sensor implanted in a subcutaneous tissue of a patient are both made of slender and soft medical polymer materials. Because of the special nature of the materials and the shapes of the two discrete components, they both need to be put into the subcutaneous tissue of a patient with a help of a puncture needle with a certain rigidity to puncture the skin of the patient. Thereafter, the needle is pulled out, leaving the two components in the subcutaneous tissue. The glucose sensor and the indwelling cannula have similar processes of puncture and indwelling. Moreover, the glucose sensor and the indwelling cannula are also the same in the aspects such as area of action on body, disposable using, aseptic production, etc.
Regarding the above-mentioned shortcomings of the prior art, an object of the present disclosure is to provide a disposable tubeless fluid delivery system for solving the problems such as large size, high costs, complex components, and inconvenient wearing, where the disposable tubeless fluid delivery system integrates a pump base and a wireless control device, and is easy to use.
In order to achieve the above-mentioned purposes and other related purposes, the present disclosure provides a disposable tubeless fluid delivery system, including: a button unit configured to receive instructions given by a user through pressing button; a key unit configured to output a selection instruction indicating at least one working mode, wherein the at least one working mode is selected from a group consisting of a basal rate delivery mode, a programmable basal rate delivery mode, an delivery suspend mode, a system locking mode and a wireless control mode; a fluid reservoir unit configured to store a fluid; an indwelling unit configured to let through the fluid to a patient when it is implanted in a subcutaneous tissue of the patient, wherein the indwelling unit includes an indwelling cannula configured to be implanted in the subcutaneous tissue of the patient; a fluid driving unit configured to deliver the fluid stored in the fluid reservoir unit to the subcutaneous tissue of the patient via the indwelling unit, when it receives an delivery instruction; and a control unit coupled to the button unit, the key unit, the fluid reservoir unit, the indwelling unit and the fluid driving unit, wherein the control unit is configured to, when it receives a button-pressing instruction, the selection instruction of the working mode, or a combination thereof, output the corresponding delivery instruction to the fluid driving unit, so as to control the fluid driving unit to deliver the fluid or suspend fluid delivery.
Optionally, the button unit includes physical buttons, touch buttons, or a combination thereof, where the physical buttons include a first physical button configured to set fluid dose, and a second physical button configured to input a confirmation instruction, one of the physical buttons is provided with raised dots to be distinguished with the other physical button.
Optionally, the key unit includes a key and a socket, and the key further includes a handle configured to combine and separate the key and the socket.
In some embodiments, the key includes a key shell, a built-in electric circuit located inside the key shell, and a plug embedded in the key shell. An O-shaped sealing ring is circumferentially set on the key shell. The built-in electric circuit is an analog circuit including electric resistances, electric capacities or a combination thereof, or a digital integrated circuit including Flash, EEROM, or one-time DATA BURNING type memory device, or a digital integrated circuit with identity recognition function, or a digital integrated circuit with an authentication function, an encryption function or a combination thereof, or a digital-analog hybrid integrated circuit. The socket includes a slot and a connector set in the slot. The connector is used to be electrically connected with the built-in electric circuit when the key is inserted into the socket. An O-shaped sealing ring is set on the surface on which the connector is attached with the socket. The plug is inserted into the connector and thus electrically connected with the connector, when the key is inserted into the socket. The O-shaped sealing ring on the key shell and the socket fit tightly to achieve waterproof seal.
In some embodiments, the socket is a sealed groove, and the key is a sensing key which includes a key shell and a sensor circuit located in the key shell. The sensor circuit includes a magnetic sensor, an optical sensor, a near field communication (NFC) tag or a radio frequency identification (RFID) tag.
Optionally, a buzzer cavity is set in a shell of the disposable tubeless fluid delivery system. A buzzer is set in the buzzer cavity, where the buzzer is configured to produce a buzz to sound an alarm, a reminder, or a combination thereof, and the buzzer is also configured to transmit ultrasonic data. The buzzer is connected to the control unit via a wire or a contact.
Optionally, a groove is set in a shell of the disposable tubeless fluid delivery system and a vibration motor is disposed in the groove, where the vibration motor is connected to the control unit via a wire.
Optionally, the disposable tubeless fluid delivery system further includes an indicator light, a transparent portion is correspondingly set on a shell of the disposable tubeless fluid delivery system, such that the indicator light indicates a system state by flashing through the transparent portion.
Optionally, the disposable tubeless fluid delivery system further includes a glucose sensor configured to dynamically monitor glucose level and a glucose monitoring module configured to process effective glucose signals output by the glucose sensor, wherein the glucose sensor is integrated in the indwelling unit, the glucose monitoring module is integrated in the control unit connected to the indwelling unit.
Optionally, the disposable tubeless fluid delivery system includes a controller and a pump base connected to the controller, where the control unit, the button unit and the key unit are set on the controller, and the fluid reservoir unit and the indwelling unit are set on the pump base.
As is mentioned above, the disposable tubeless fluid delivery system provided in the present disclosure uses independent control structure to enhance convenience of using and wearing. That is, the control unit, the button unit and the key unit are set in one device, where the control unit is configured to process an instruction given by a user, and coordinate and manage the device operation, while the button unit and the key unit are configured to realize communications between the user and the device. Furthermore, setting the button and the key on the device realizes the fluid delivery and completes treatment for a patient under the cooperations of the buzzer, the vibration motor and the indicator light. In some embodiments, the indwelling unit is combined with the glucose sensor, and the control unit is combined with the glucose monitoring module. As such, the disposable tubeless fluid delivery system can realize both glucose monitoring and fluid delivery, so as to complete treatment for the patient. Specifically, when the patient is being treated, he/she sticks the whole device to his/her skin, and sets up a program of fluid delivery by the button unit and/or the key unit. In response to the user's instruction, or when the fluid stored in the pump base runs out, or the device breaks down, the disposable tubeless fluid delivery system will remind the user to do the next step operation by using the buzzer, the vibration motor, the indicator light, or a combination thereof.
The embodiments of the present disclosure are described in the following through specific examples, and those skilled in the art can easily understand other advantages and effects of the present disclosure according to the content disclosed in the specification.
Referring to the
The present disclosure provides a disposable tubeless fluid delivery system configured to achieve a patient disease treatment by continuously delivering a fluid into the patient. In actual practice, the fluid delivery device is widely used in the treatment of diabetes. The fluid delivery device continuously delivers insulin to a subcutaneous tissue of the patient based on a dosage required by the patient, and then simulates the secretion function of pancreas and stabilizes glucose of the patient. Referring to
In some embodiments, the disposable tubeless fluid delivery system 1 may integrate the button unit, the key unit, the indwelling unit, the fluid driving unit and the control unit in a box or a shell 10. Referring to
In some embodiments, the disposable tubeless fluid delivery system 1 includes a controller 101 and a pump base 102 connected to the controller 101 or separated from the controller 101. The control unit, the button unit and the key unit are set on the controller 101. The fluid reservoir unit, the fluid driving unit and the indwelling unit are set on the pump base 102. Referring to
Referring to
In some embodiments, referring to
Referring to
As shown in
The button unit configured to receive instructions given by a user through pressing button. In some embodiments, the button unit includes physical buttons, touch buttons, or a combination thereof. The instructions are some instructions given by the user through pressing button, for example, opening, closing and restarting. Alternatively, a combined key is used to realize some instructions such as system infusion suspending, system hibernating and system programming.
In some embodiments, the physical buttons include a first physical button configured to set fluid dose, and a second physical button configured to input a confirmation instruction, one of the physical buttons is provided with raised dots to be distinguished with the other physical button. In some embodiments, the touch button includes a capacitive touch key, a resistive touch key or a touch screen. When the keying is the touch key, different keys have different labels to make a distinction, for example, a color label, graphics label.
The key unit is configured to output a selection instruction indicating at least one working mode, where the at least one working mode is selected from a group consisting of a basal rate delivery mode, a programmable basal rate delivery mode, an delivery suspend mode, a system locking mode and a wireless control mode. In some embodiments, the key unit may be more than one. That is, each key unit has a prestored working mode, for example, a key unit with prestored basal rate delivery mode, a key unit with programmable basal rate delivery mode prestored based on actual situation of the patient.
In some embodiments, the key unit includes a key 13 and a first socket 12. Referring to
In order to wear or manage, the key 13 further includes a handle 14 configured to combine and separate the key 13 and the first socket 12. Referring to
In some embodiments, the key 13 includes a key shell 130 and a first plug 131 embedded in the key shell 130, the key shell 130 has a built-in electric circuit located inside the key shell 130, where a first portion of the first plug 131 is embedded in the key shell 130 and a second portion of the first plug 131 protrudes out of the key shell 130, and the first socket 12 comprises a first groove 123 with a first slot 124 disposed on a bottom of the first groove 123, where a side wall of the first groove 123 surrounds the first slot 124, the second portion of the first plug 131 is configured to be inserted into the first slot 124 from an opening side of the first groove 123 and the key shell 130 is configured to contact with the side wall of the first groove 123. Specifically, the built-in electric circuit is an analog circuit including electric resistances, electric capacities or a combination thereof, or a digital integrated circuit including Flash, EEROM, or one-time DATA BURNING type memory device, or a digital integrated circuit with identity recognition function, or a digital integrated circuit with an authentication function, an encryption function or a combination thereof, or a digital-analog hybrid integrated circuit. The built-in electric circuit is set on the printed circuit board (PCB).
Referring to
Referring to
The fluid reservoir unit is configured to store a fluid. In some embodiments, the fluid is insulin used for treatment of diabetic. But it is not limited to insulin, and the fluid stored in the fluid reservoir unit may be different based on the actual need of patient.
The indwelling unit is configured to let through the fluid to a patient when it is implanted in a subcutaneous tissue of the patient, where the indwelling unit includes an indwelling cannula configured to be implanted in the subcutaneous tissue of the patient. In some embodiments, the indwelling cannula is implanted in a subcutaneous tissue in the patient via the aid of a steel needle. Specifically, when the indwelling cannula covers the steel needle, the inside of the steel needle is hollow; when the steel needle is a groove steel needle, the indwelling cannula is set in the groove of the groove steel needle; similarly, the steel needle may also be a steel needle with an inner chamber, when the inner chamber is used as a termination of delivering drug termination.
The fluid driving unit is configured to deliver the drug fluid stored in the fluid reservoir unit to the subcutaneous tissue of the patient by the indwelling unit, when it receives a delivery instruction. In some embodiments, the fluid driving unit includes an ejection device and a subcutaneous hose installation device, which are configured to implant the indwelling cannula of the indwelling unit into the skin of the patient. When the indwelling cannula is implanted, the subcutaneous cannula installation device uses steel needle to puncture the skin of the patient by the ejection device and implants the indwelling cannula in the subcutaneous tissue of the patient, and then the steel needle is pulled out by a return pin device, so the fluid stored in the fluid reservoir unit is delivered to the subcutaneous tissue of the patient through the indwelling unit.
In some embodiments, the disposable tubeless fluid delivery system further includes a glucose sensor configured to dynamically monitor glucose level and a glucose monitoring module configured to process effective glucose signals output by the glucose sensor, where the glucose sensor is integrated in the indwelling unit, the glucose monitoring module is integrated in the control unit connected to the indwelling unit. In some embodiments, the glucose sensor is set on an outside surface of the indwelling cannula, and the glucose monitoring module is set in the shell of the disposable tubeless fluid delivery system, but it is not limited to the embodiments disclosed, other means should also apply to the present disclosure, other means includes any means which can realize combination of the glucose sensor and the indwelling unit, and realize combination of the glucose monitoring module and the control unit connected to the indwelling unit.
The control unit is respectively coupled to the button unit, the key unit, the fluid reservoir unit, the indwelling unit and the fluid driving unit, where the control unit is configured to, when it receives the button-pressing instruction, the selection instruction of the working mode, or a combination thereof, output the corresponding delivery instruction to the fluid driving unit, so as to control the fluid driving unit to deliver the fluid or suspend fluid delivery. In some embodiments, the control unit is prestored various button-pressing instructions and working mode set corresponding to the key unit, where the working mode includes a basal rate delivery mode, a programmable basal rate delivery mode, an delivery suspend mode, a system locking mode and a wireless control mode. The control unit may be a single chip, or other microprocessor, which is configured to receive, transmit and return signal of all units, and coordinate and manage all units, for example, it may manage amount of the fluid stored in the fluid reservoir unit, when the amount of the fluid is insufficient, it outputs a reminder and an alarm, or when the device breaks down. The control unit also manages the functional module such as a wireless transmission module, power supply module.
In an optional embodiment, a buzzer cavity is set in a shell of the disposable tubeless fluid delivery system, a buzzer is set in the buzzer cavity, where the buzzer is configured to produce a buzz to sound an alarm, a reminder, or a combination thereof, and the buzzer is also configured to transmit ultrasonic data. The buzzer is connected to the control unit via a wire or a contact. In response to the user's instruction, or when the fluid stored in the pump base 102 runs out, or the device breaks down, the buzzer may remind, alarm or transmit data by ultrasound.
In an optional embodiment, a groove is set in the shell of the disposable tubeless fluid delivery system, and a vibration motor is set in the groove, where the vibration motor is connected to the control unit by a wire or a contact. In response to the user's instruction, or when the fluid stored in the pump base 102 runs out, or the device breaks down, the vibration motor may remind user to do next step operation or alarm.
In an optional embodiment, the disposable tubeless fluid delivery system further includes an indicator light, a transparent portion is correspondingly set in the shell of the disposable tubeless fluid delivery system, the indicator light indicates a system state by flashing through the transparent portion and reminds user.
As is mentioned above, referring to
Referring to
Referring to
A second groove 160 is set in the shell of the controller 101, and the vibration motor 16 is set in the second groove 160, where the vibration motor 16 is connected to the control unit via the wire. In response to the user's instruction, or when the fluid stored in the pump base 102 runs out, or the device breaks down, the vibration motor 16 may remind user to do next step operation or alarm.
The indicator light 17 is set in the shell of the controller 101, a transparent portion 170 is correspondingly set on the shell of the controller 101, the indicator light 17 indicates a system state by flashing through transparent portion and reminds user.
In summary, the disposable tubeless fluid delivery system provided in the present disclosure uses independent control structure to enhance convenience of using and wearing. That is, the control unit, the button unit and the key unit are set in one device, where the control unit is configured to process an instruction given by a user, and coordinate and manage the device operation, while the button unit and the key unit are configured to realize communications between the user and the device. Furthermore, setting the button and the key on the device realizes the fluid delivery and completes treatment for a patient under the cooperations of the buzzer, the vibration motor and the indicator light. In some embodiments, the indwelling unit is combined with the glucose sensor, and the control unit is combined with the glucose monitoring module. As such, the disposable tubeless fluid delivery system can realize both glucose monitoring and fluid delivery, so as to complete treatment for the patient. Specifically, when the patient is being treated, he/she sticks the whole device to his/her skin, and sets up a program of fluid delivery by the button unit and/or the key unit. In response to the user's instruction, or when the fluid stored in the pump base runs out, or the device breaks down, the disposable tubeless fluid delivery system will remind the user to do the next step operation by using the buzzer, the vibration motor, the indicator light, or a combination thereof. The present disclosure overcomes the various shortcomings of the current technology and has high industrial utilization value.
The above descriptions of the detailed embodiments are only to illustrate the principle and the effect of the present disclosure, and it is not to limit the scope of the present disclosure. Those skilled in the art can modify or change the embodiments without departing from the spirit and scope of the present disclosure. Accordingly, all equivalent modifications and variations completed by persons of ordinary skill in the art, without departing from the spirit and technical idea of the present disclosure, should fall within the scope of the present disclosure defined by the appended claims.
Number | Date | Country | Kind |
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2014 1 0446153 | Sep 2014 | CN | national |
Filing Document | Filing Date | Country | Kind |
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PCT/CN2014/088615 | 10/15/2014 | WO | 00 |
Publishing Document | Publishing Date | Country | Kind |
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WO2016/033854 | 3/10/2016 | WO | A |
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Number | Date | Country | |
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