CN218793375U

CN218793375U - Insulin injection system

Info

Publication number: CN218793375U
Application number: CN202221611164.4U
Authority: CN
Inventors: 崔悦
Original assignee: Peking University
Current assignee: Peking University
Priority date: 2022-06-24
Filing date: 2022-06-24
Publication date: 2023-04-07
Anticipated expiration: 2032-06-24

Abstract

The application discloses an insulin injection system, which comprises a drug injection pump based on an electrochemical pump, a microtubule electrochemical enzyme sensor and a circuit module. The circuit module is connected with the sensor and the pump through leads. The sensor detects the glucose concentration of the interstitial fluid, the circuit module provides constant voltage for the sensor and detects the current generated by the sensor, and the glucose of the circuit module outputs driving current or driving voltage matched with the glucose concentration to the electrochemical pump through signal processing; the drug infusion pump is used to infuse insulin to a patient under the drive of a drive current or drive voltage. Because the system can automatically administer the medicine to the patient based on the glucose concentration of the patient, and the dosage is matched with the glucose concentration of the patient, the problem that manual insulin injection cannot ensure that the glucose is in a normal range is solved.

Description

Insulin injection system

Technical Field

The application relates to the technical field of medical instruments, in particular to an insulin injection system.

Background

In the medical field, some patients need to frequently inject corresponding medicines for a long time for special reasons so as to keep the body stable and healthy in corresponding functions, such as diabetics, and insulin supplementation is required according to a preset rule in order to ensure that glucose in the body is stable and normal.

At present, diabetes patients need to be injected and administered by medical care personnel or patients themselves manually, and the glucose cannot be ensured to be in a normal range because the manual operation is difficult to strictly comply with the time requirement.

SUMMERY OF THE UTILITY MODEL

In order to solve the problems, the application provides an insulin injection system which is used for automatically administering drugs to a diabetic patient so as to solve the problem that manual insulin injection cannot ensure that glucose is in a normal range.

In view of this, the present application discloses an insulin injection system comprising a drug injection pump based on electrochemical principles, a sensor circuit module, a pump driving circuit module and a controller, wherein:

the sensor is used for being attached to the skin of a patient and used for generating a current signal based on glucose of subcutaneous tissue fluid;

the sensor circuit module is connected with the sensor and used for receiving the current signal and outputting the glucose concentration matched with the current signal through the output end of the sensor circuit module;

the controller is provided with a signal input end and a signal output end, the signal input end is connected with the output end of the sensor circuit module and used for receiving the glucose concentration, and the signal output end is configured to output a control signal matched with the glucose concentration;

the pump driving circuit module is respectively connected with the signal output end and an electrode of the drug injection pump and is used for outputting driving current or driving voltage matched with the control signal to the drug injection pump;

the drug injection pump is used for injecting insulin to the patient based on an electrochemical reaction under the driving of the driving current or the driving voltage.

Optionally, the drug infusion pump comprises a drive component and a drug storage component, wherein:

the driving component is arranged inside the medicine storage component and used for generating a driving force based on an electrochemical reaction principle, the driving force is applied inside the medicine storage component, the driving component comprises an electrochemical element, the electrochemical element is connected to the outside of the medicine storage component through a lead and used for receiving preset current, the electrochemical element is used for generating gas based on the preset current, the gas is used for generating the driving force, and the electrochemical element is an electrode with a thickness of nanometer or micrometer, which is manufactured through a metal evaporation process, a screen printing process or a magnetron sputtering process;

the medicine storage component is internally provided with medicine liquid, the medicine liquid is pushed out to the outside of the medicine storage component along at least one liquid outlet hole in the medicine storage component under the driving of the driving force, so that the liquid outlet hole can administer medicine to a patient, or the medicine liquid can be administered to the patient along an injection mechanism connected to the liquid outlet hole.

Optionally, the electrode is a metal electrode, a carbon electrode or a composite conductive material electrode.

Optionally, the electrode is an interdigitated electrode, a flat electrode, a columnar electrode or an irregular electrode.

Optionally, the substrate of the finger-inserted electrode is a hard substrate, a flexible substrate or a stretchable elastic substrate.

Optionally, the substrate has a curved surface shape, a planar shape, a zigzag shape, a corrugated shape, or a micro-porous shape.

Optionally, the driving component further comprises a driving cavity covering the electrochemical element, and the driving cavity is located inside the medicine storage component;

the driving cavity is used for containing electrolyte, the electrolyte generates electrochemical reaction under the action of the electrochemical element, so that the driving cavity generates deformation, and the deformation of the driving cavity generates driving force for the liquid medicine.

Optionally, the electrolyte is pure water or a salt solution.

Optionally, the sensor includes a tubular structure and a plurality of sensor electrodes, and the plurality of sensor electrodes are disposed on an outer wall of the tubular structure and connected to the sensor circuit module.

Optionally, the cross-section of the tubular structure is circular, square or multi-deformed.

Optionally, the length of the tubular structure is 1 to 20mm, and the diameter of the tubular structure is 50 micrometers to 2 mm.

According to the technical scheme, the insulin injection system comprises a drug injection pump, a sensor circuit module, a pump driving circuit module and a controller. The sensor circuit module monitors the glucose concentration of the patient through the current signal detected by the sensor; the controller is connected with the sensor circuit module and used for receiving the glucose concentration and outputting a control signal matched with the glucose concentration to a line at the driving end of the pump; the pump driving circuit module is respectively connected with the electrodes of the drug injection pump and is used for outputting driving current or driving voltage matched with the control signal to the drug injection pump; the drug infusion pump is used to infuse insulin to a patient under the drive of a drive current or drive voltage. Because the system can automatically administer the medicine to the patient based on the glucose concentration of the patient, and the dosage is matched with the glucose concentration of the patient, the problem that manual insulin injection cannot ensure that the glucose is in a normal range is solved.

Drawings

In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, it is obvious that the drawings in the following description are only some embodiments of the present application, and for those skilled in the art, other drawings can be obtained according to the drawings without creative efforts.

FIG. 1a is a schematic view of an insulin injection system according to an embodiment of the present application;

FIG. 1b is a schematic view of another insulin injection system according to an embodiment of the present application;

FIG. 1c is a block diagram of an insulin injection system according to an embodiment of the present application;

FIG. 2 is a schematic view of a medication infusion pump in accordance with an embodiment of the present application;

FIG. 3 is a schematic view of a substrate having a curved shape according to an embodiment of the present application;

FIG. 4 is a schematic view of a substrate having a saw-tooth shape according to an embodiment of the present application;

fig. 5 is a schematic view of the wrinkled substrate of the embodiment of the present application in a stretched state;

fig. 6 is a schematic view of a corrugated substrate according to an embodiment of the present disclosure in a natural state;

FIG. 7 is a top view of a platinum finger electrode according to an embodiment of the present application;

FIG. 8 is a schematic diagram of a sensor electrode according to an embodiment of the present application;

FIG. 9 is a schematic view of another sensor electrode according to an embodiment of the present application.

Detailed Description

The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application, and it is obvious that the described embodiments are only a part of the embodiments of the present application, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present application.

FIG. 1a is a schematic view of an insulin injection system according to an embodiment of the present application.

The present embodiment provides an insulin injection system for injecting insulin to a patient in need of insulin injection in a timed and quantitative manner so as to keep the glucose of the patient within a normal range. The system includes a drug infusion pump 10, a pump drive circuit module 20, a controller 30, a sensor circuit module 40, and a sensor 50.

Referring to fig. 1a, the drug injection pump of the specific structure of the insulin injection system is provided with at least one micro tube 14 having one end communicating with the inside of the drug storage part and the other end for entering the subcutaneous space of the patient so that the insulin in the drug storage part enters the body of the patient under the driving of the driving part, and the sensor electrode 52 of the sensor is disposed on the outer wall of the micro tube and connected to the sensor circuit module 40. The pump driving circuit module 30, the sensor circuit module 40 and the controller 30 are disposed at a lower portion of the medicine injection pump.

The insulin injection system may also be in the shape shown in fig. 1b, with the final form being a button for ease of wearing by the patient.

As shown in fig. 1c, the controller is provided with a signal input terminal 31 and a signal output terminal 32, the signal input terminal is connected with the sensor circuit module, the signal output terminal is connected with the pump driving circuit module, and the pump driving circuit module is further connected with the drug injection pump.

The sensor is arranged on the skin of a patient and used for detecting the glucose concentration of the patient through a sensor electrode of the sensor, and the sensor electrode of the sensor generates a current signal through the detection of subcutaneous tissue fluid and outputs the current signal to the sensor circuit module. The sensor circuit module is connected with the sensor and used for generating the glucose concentration based on the current signal and outputting the glucose concentration to the signal input end of the controller through the output end of the sensor circuit module. The controller processes the glucose concentration after receiving the glucose concentration, namely determining parameters such as injection frequency and injection time according to the glucose concentration, and outputting a control signal to the pump driving circuit module at a preset time based on the parameters. The pump driving circuit module outputs driving power to the drug injection pump after receiving the control signal.

Generally, the output signal of the sensor is a micro-voltage signal of-0.1-0.6V, and the voltage range and the voltage fluctuation of the sensor do not have adverse effect on human bodies.

The drug injection pump comprises an electrode, the electrode is connected with a pump driving circuit module and used for generating a driving force based on an electrochemical reaction under the driving of driving current or driving voltage, and insulin is injected into a patient body by the driving force. The voltage range of the driving voltage is 0.1-20V, and the voltage is the normal tolerance voltage of the human body and cannot cause harm to the human body.

It can be seen from the above technical solutions that the present embodiment provides an insulin injection system, which includes a drug injection pump, a sensor circuit module, a pump driving circuit module, and a controller. The sensor circuit module monitors the glucose concentration of the patient through the current signal detected by the sensor; the controller is connected with the sensor circuit module and used for receiving the glucose concentration and outputting a control signal matched with the glucose concentration to a line at the driving end of the pump; the pump driving circuit module is respectively connected with the electrodes of the drug injection pump and is used for outputting driving current or driving voltage matched with the control signal to the drug injection pump; drug infusion pumps are used to infuse insulin to a patient driven by a drive current or drive voltage. Because the system can automatically administer the medicine to the patient based on the glucose concentration of the patient, and the dosage is matched with the glucose concentration of the patient, the problem that manual insulin injection cannot ensure that the glucose is in a normal range is solved.

In one embodiment of the present application, the drug infusion pump includes a drug storage component 11 and a drive component 12 disposed within the drug storage component, as shown in fig. 2.

The drive member further comprises a drive chamber 13. The driving cavity is positioned in the medicine storage component and covers the electrochemical component, electrolyte is loaded in the driving cavity, the electrolyte generates redox reaction under the action of an electrochemical element, and the generated gas drives the driving cavity to expand so as to generate driving force for liquid medicine in the medicine storage component. The electrolyte can be selected from pure water, salt solution, etc.

The drive chamber is formed by the assembly of a base plate and a cover plate, which are bonded together at their edges by adhesive bonding, thereby forming a cavity therein for receiving the electrolyte and the electrochemical element. The diameter of the cover plate is preferably 8mm, and the height is preferably 7mm.

The medicine storage part in the embodiment can be produced by a 3D printing process, an injection molding process or other processes, the material of the medicine storage part is preferably Teflon material, and the thickness of the film is preferably 30 μm. The size of the medicine storage part is 20mm in diameter and 10mm in height.

The medicine storage part is a part with a cavity, liquid medicine for injection is contained in the cavity, and the medicine storage part is provided with at least one liquid outlet hole 111. The driving part is arranged in the medicine storage part and generates pushing force based on the electrochemical principle, namely based on the action of current input by control equipment outside.

The medicine storage component discharges liquid medicine through the liquid outlet hole by deformation or pressure change under the action of the pushing force generated by the driving component, and the liquid outlet hole realizes injection to a patient through the guide pipe and the micro-tube array. When the medicine injection pump is arranged inside a human body, the liquid outlet hole can be used for administering medicine to a patient without an additional element.

In a specific embodiment of the application, the corresponding part of the medicine storage cavity is provided with a liquid injection hole besides a liquid outlet hole, liquid medicine can be injected into the medicine storage cavity through the liquid injection hole, and sealing is realized through the movable plug body after the liquid medicine is injected.

The diameter of the liquid injection hole is 1-5 mm, and the diameter of the liquid outlet hole is 1-5 mm. In the present embodiment, the diameter of the liquid inlet is preferably 3mm, and the diameter of the liquid outlet is also preferably 3mm. The sizes of the liquid injection hole and the liquid outlet hole can be in the micron order.

The driving part is used for generating the pushing force based on the electrochemical reaction principle, namely, generating gas based on driving current or driving voltage, so that the gas generates the pushing force on the liquid medicine in the medicine storage part through volume expansion.

The driving component comprises an electrochemical element, and the electrochemical element comprises at least one pair of electrodes which are connected with the control equipment through leads. The electrode is a metal electrode or a composite conductive material electrode. When the metal electrode is selected, platinum, gold, silver, copper and the like can be adopted, and a carbon material electrode can also be selected. The electrode causes water or other components in the liquid medicine to undergo oxidation-reduction reaction or electrolysis reaction based on the current, thereby generating corresponding gas.

The electrodes in an electrochemical device have an overall area of 1 mm to 1 cm and a thickness of 50 nm to 500 μm. The electrode can be manufactured by a sputtering or evaporation method of micro-nano processing, and the material of the electrode can be platinum, gold or other materials with stable chemical properties, and can also be manufactured by a screen printing method.

The electrodes are arranged on a substrate, which may be considered as a part of the electrodes, for carrying the sensor electrodes. The substrate may have a planar shape, a curved shape, a zigzag shape, a microtube shape, or a corrugated shape, as shown in fig. 3 and 4. The shape of the substrate may also be a corrugated shape, to which the electrodes 12 are attached, and when the substrate is stretched, the electrode shape becomes flat, as shown in fig. 5, and when in a natural state, the substrate may be bent and deformed, as shown in fig. 6. When selecting the material of base plate, can select for use flexible material as the base plate, also can select for use hard materials such as glass as the base plate, can also select for use the elastic base that can stretch.

The electrochemical element is preferably a platinum finger electrode, the platinum finger electrode comprises platinum electrode plates which are crossly matched, the width of each platinum electrode plate is 100 mu m, and the distance between the platinum electrode plates is also 100 mu m. The platinum finger electrode is connected to the outside of the drug storage member through a lead wire for receiving current through the lead wire, as shown in fig. 7.

In addition, the electrodes in this embodiment may also be in the form of two plate electrodes facing each other up and down, in addition to the platinum finger electrode, where one plate electrode is located on the substrate, the other plate electrode is located above the substrate, and the other plate electrode may also be located on the inner wall of the driving cavity. In addition, the electrodes can also be two or two groups of electrodes which are positioned on the substrate and stand upwards.

The sensor in the embodiment of the application comprises a tubular structure and a sensor electrode which is connected with a sensor circuit module and used for outputting a current signal to the module under the driving of a driving voltage output by the sensor circuit module. The cross-section of the tubular structure may be square, hexagonal, circular or other shape.

The length of the tubular structure is 1-20 mm, the diameter of the outer wall is 50-1000 microns, and the thickness of the side wall is 10-200 microns. The width of the sensor electrode is 50-1000 microns, the length is 1-15 mm, and the thickness is 50-100 microns.

When the square tubular structure 51 is selected, the sensor electrodes 52 are arranged oppositely on the opposite side walls, as shown in fig. 8. In this case, one of the two electrodes is a working electrode and the other is a reference/counter electrode, and this electrode has both functions of the reference electrode and the counter electrode. The working electrode is a metal electrode, such as a gold electrode, a platinum electrode, or a carbon electrode. The reference/counter electrode can be a silver/silver chloride electrode.

When a tubular structure 53 having a hexagonal cross section is used, as shown in fig. 9, sensor electrodes are disposed on adjacent side walls, respectively, working electrode 541, reference electrode 542, and counter electrode 543. The working electrode and the counter electrode can be metal electrodes, such as gold electrodes or platinum electrodes, and can also be carbon electrodes. The reference electrode can be a silver/silver chloride electrode. Glucose oxidase is immobilized on the working electrode, and the enzyme catalyzes glucose to generate hydrogen peroxide, so that the electrode generates current change. The working electrode material can be gold, platinum, carbon and other materials plated with Prussian blue, or a layer of Prussian blue gold, platinum and carbon materials is combined, then glucose oxidase is fixed, and a layer of biocompatible material is continuously covered on the glucose oxidase; the reference electrode material may be silver/silver chloride; the counter electrode is made of gold, platinum or carbon.

The sensor electrode may be manufactured by a micro-machining method or may be manufactured by screen printing.

The tubular structure is made of polyethylene terephthalate, polyvinyl chloride, glass fiber, polyurethane, silk fibroin, chitosan, polylactic acid, polyvinyl chloride, polyimide thermoplastic polyurethane elastomer, silica gel, rubber, latex, thermoplastic elastomer, perfluoroethylene propylene copolymer or polytetrafluoroethylene.

The length of the tubular structure may be 1 mm to 20mm and the diameter thereof may be 50 μm to 2 mm, so that it may be deep into the dermis or fat layer of the skin, and the effect may be more remarkable by injecting insulin into the fat layer.

The drug injection pump provided by the embodiment is manufactured according to the following manufacturing process, and specifically comprises the following steps:

s1, manufacturing two electrodes on a substrate.

Specifically, the electrodes are fabricated on the substrate by a magnetron sputtering process, a screen printing process, a metal evaporation process or other processes. The base plate then forms the basis for the fabrication of the entire drug infusion pump. The substrate can be made of glass, plastic, polyethylene terephthalate (PET) or Polyimide (Polyimide).

The electrode is a platinum finger electrode, a carbon finger electrode, a gold finger electrode or a composite conductive material finger electrode, that is, a finger electrode made of platinum material, carbon material, gold material or composite conductive material, and the present embodiment describes the finger electrode by taking the platinum finger electrode as an example, and the platinum finger electrode includes a titanium layer attached to a substrate and a platinum layer attached to the titanium layer.

The size of the substrate is 2x2cm, when the substrate is manufactured, a titanium film and a platinum film are sequentially deposited on a glass substrate, and then the platinum finger electrode is manufactured through a photoetching process, namely, through a photoetching or etching mode, so that the platinum finger electrode is formed.

And S2, arranging a driving cavity covering the electrode on the substrate.

Specifically, a driving cavity is formed on the substrate through a 3D printing mode and an injection molding process. And adhering the driving cavity on the substrate through the sealing glue. Deionized water or saline solution is placed on the interdigitated electrodes. Application of a current or voltage to the electrodes will generate a bubble formation drive on the interdigitated electrodes. And covering the drive cavity with a teflon film to form a complete and sealed cavity.

And S3, manufacturing a medicine storage part covering the driving cavity on the substrate.

And finally, generating a medicine storage part through a 3D printing mode, an injection molding process or other processes, so that the medicine storage part can completely cover the driving cavity.

The manufacturing of the drug injection pump can be realized through the arrangement.

For the device embodiment, since it is basically similar to the method embodiment, the description is simple, and for the relevant points, refer to the partial description of the method embodiment.

The embodiments in the present specification are described in a progressive manner, each embodiment focuses on differences from other embodiments, and the same and similar parts among the embodiments are referred to each other.

While preferred embodiments of the present application have been described, additional variations and modifications of these embodiments may occur to those skilled in the art once they learn of the basic inventive concepts. Therefore, it is intended that the appended claims be interpreted as including the preferred embodiment and all changes and modifications that fall within the true scope of the embodiments of the present application.

Finally, it should also be noted that, herein, relational terms such as first and second, and the like may be used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. Also, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or terminal that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or terminal. Without further limitation, an element defined by the phrase "comprising a … …" does not exclude the presence of another identical element in a process, method, article, or terminal apparatus that comprises the element.

The technical solutions provided by the present application are introduced in detail above, and specific examples are applied in the present application to explain the principles and embodiments of the present application, and the descriptions of the above examples are only used to help understanding the method and the core ideas of the present application; meanwhile, for a person skilled in the art, according to the idea of the present application, there may be variations in the specific embodiments and the application scope, and in summary, the content of the present specification should not be construed as a limitation to the present application.

Claims

1. An insulin injection system comprising a drug injection pump based on electrochemical principles, a sensor circuit module, a pump drive circuit module and a controller, wherein:

the pump driving circuit module is respectively connected with the signal output end and the electrode of the drug injection pump and is used for outputting driving current or driving voltage matched with the control signal to the drug injection pump;

2. The insulin injection system of claim 1, wherein the drug infusion pump comprises a drive component and a drug storage component, wherein:

the driving component is arranged inside the medicine storage component and used for generating a pushing force based on an electrochemical reaction principle, the pushing force is applied to the inside of the medicine storage component, the driving component comprises an electrochemical element, the electrochemical element is connected to the outside of the medicine storage component through a lead and used for receiving preset current, the electrochemical element is used for generating gas based on the preset current, the gas is used for generating the pushing force, and the electrochemical element is an electrode with a thickness of nanometer or micrometer, and is manufactured through a metal evaporation process, a screen printing process or a magnetron sputtering process;

3. The insulin injection system according to claim 2, wherein the electrode is a metal electrode, a carbon electrode, or a composite conductive material electrode.

4. The insulin injection system according to claim 3, wherein the electrode is a finger electrode, a plate electrode, or a cylindrical electrode;

the substrate of the finger inserting electrode is a hard substrate, a flexible substrate or a stretchable elastic substrate.

5. The insulin injection system according to claim 4, wherein the shape of the base plate is a curved shape, a planar shape, a zigzag shape, a corrugated shape or a micro-porous shape.

6. The insulin injection system according to claim 2, wherein the drive member further comprises a drive cavity encasing the electrochemical element, the drive cavity being located inside the drug storage member;

7. The insulin injection system according to claim 6, wherein the electrolyte is pure water or a saline solution.

8. The insulin injection system of claim 1, wherein the sensor comprises a tubular structure and a plurality of sensor electrodes disposed on an outer wall of the tubular structure and connected to the sensor circuit module.

9. The insulin injection system according to claim 8, wherein the tubular structure has a cross-section that is circular, square or multi-deformed.

10. The insulin injection system according to claim 8, wherein the tubular structure has a length of 1 to 20mm, an outer wall diameter of 50 to 1000 microns, and a sidewall thickness of 10 to 200 microns.