CN219230994U

CN219230994U - Closed loop system of sandwich sensor and electrochemical pump

Info

Publication number: CN219230994U
Application number: CN202223501369.XU
Authority: CN
Inventors: 崔悦
Original assignee: Peking University
Current assignee: Peking University
Priority date: 2022-12-27
Filing date: 2022-12-27
Publication date: 2023-06-23
Anticipated expiration: 2032-12-27

Abstract

The utility model relates to the technical field of medical instruments, and particularly discloses a closed loop system of a sandwich sensor and an electrochemical pump, which comprises the electrochemical pump and the sandwich sensor; the electrochemical pump comprises a driving component and a medicine storage component, the electrochemical pump comprises the driving component and the medicine storage component, the sandwich sensor comprises an enzyme layer, a working electrode, a first film layer, an insulin circulation layer, a second film layer and a reference/counter electrode which are sequentially connected, and the sandwich sensor is connected with the medicine storage component.

Description

Closed loop system of sandwich sensor and electrochemical pump

Technical Field

The utility model relates to the technical field of medical instruments, in particular to a closed loop system of a sandwich sensor and an electrochemical pump.

Background

Diabetes is a chronic disease seriously jeopardizing the health of human beings in modern society, but no effective means for radically curing diabetes exists in the medical community at present, and the aim of treatment for diabetics in hospitals is to stabilize the blood sugar concentration of the patients. The automatic closed-loop control of insulin injection for diabetics is completely realized by adopting the artificial pancreas islet capable of continuously monitoring glucose change of diabetics and injecting insulin, and the method is an ideal method for controlling blood glucose concentration.

The current automatic closed-loop control system for insulin injection generally at least comprises an insulin pump and a glucose detector, and the insulin pump is controlled to pump quantitative insulin according to the glucose content after the glucose content in the tissue fluid is detected by the glucose detector. At present, the insulin pump and the glucose detector are mutually independent, and a miniature closed-loop system is not effectively integrated, so that the automatic control closed-loop system is large in size and high in cost.

Disclosure of Invention

The utility model aims to provide a closed loop system of a sandwich sensor and an electrochemical pump, which has the advantages of small volume and low cost.

The utility model is realized by adopting the following technical scheme:

a closed loop system of a sandwich sensor and an electrochemical pump, comprising an electrochemical pump and a sandwich sensor;

the electrochemical pump comprises a driving part and a medicine storage part, wherein the driving part is arranged inside the medicine storage part, the driving part comprises an electrochemical element, the electrochemical element is connected to the outside of the medicine storage part through a wire and is used for receiving preset current, the electrochemical element is used for generating gas based on the preset current, and the gas generates pushing force to push a film between the driving part and the medicine storage part to expand so as to push medicine injection;

the sandwich sensor comprises an enzyme layer, a working electrode, a first film layer, an insulin circulation layer, a second film layer and a reference/counter electrode which are sequentially connected, wherein the sandwich sensor is connected with the medicine storage component, so that insulin stored in the medicine storage component is pumped into the insulin circulation layer through a medicine outlet through the thrust generated by the electrochemical element through the medicine outlet arranged on the medicine storage component.

Further, the insulin flow layer is manufactured by a porous polymer film, the porous polymer film is manufactured by a mesoporous polymer, and the mesoporous polymer is a mixture of polyglycidyl methacrylate and polyethylene glycol or polyvinyl alcohol.

Further, the first film layer and the second film layer are both water impermeable films.

Further, the electrochemical element is a metal electrode, a carbon electrode or a composite conductive material electrode.

Further, the electrochemical element is an interdigital electrode, a flat electrode, a columnar electrode or an irregularly shaped electrode.

Further, the substrate of the interdigital electrode is a hard substrate, a flexible substrate or a stretchable elastic substrate.

Further, the driving component further comprises a driving cavity for coating the electrochemical element, and the driving cavity is positioned in the medicine storage component;

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

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

Further, the device also comprises a processor, wherein the working electrode and the reference/counter electrode are in signal connection with the processor, and the electrochemical element is connected to the processor outside the medicine storage component through a wire.

Further, the processor is disposed outside the drug storage component.

The beneficial effects of the utility model are as follows: according to the closed loop system of the sandwich sensor and the electrochemical pump, the glucose concentration in tissue fluid is detected through the working electrode and the reference/counter electrode, the driving component in the electrochemical pump is controlled to be opened according to the detected glucose concentration, so that insulin stored in the medicine storage component is pumped into the insulin circulation layer in the sandwich sensor, and then the insulin circulation layer is connected with the injection equipment for injection.

Drawings

In order to more clearly illustrate the embodiments of the present utility model 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. Like elements or portions are generally identified by like reference numerals throughout the several figures. In the drawings, elements or portions thereof are not necessarily drawn to scale.

FIG. 1 is a block diagram of a closed loop system of a sandwich sensor and an electrochemical pump according to an embodiment of the utility model.

Fig. 2 is a schematic diagram of an electrochemical pump of a closed loop system of a sandwich sensor and an electrochemical pump according to an embodiment of the utility model.

Fig. 3 is a schematic diagram of a sandwich sensor and a closed loop system of an electrochemical pump according to an embodiment of the present utility model.

Fig. 4 is a schematic structural diagram of a further electrochemical pump of a closed loop system of a sandwich sensor and an electrochemical pump according to an embodiment of the utility model.

Fig. 5 is a schematic structural diagram of a further electrochemical pump of a closed loop system of a sandwich sensor and an electrochemical pump according to an embodiment of the utility model.

Fig. 6 is a schematic structural diagram of a further electrochemical pump of a closed loop system of a sandwich sensor and an electrochemical pump according to an embodiment of the utility model.

Fig. 7 is a schematic structural diagram of a platinum interdigital electrode of another electrochemical pump of a closed loop system of a sandwich sensor and an electrochemical pump according to an embodiment of the present utility model.

Fig. 8 is a schematic structural diagram of a further electrochemical pump of a closed loop system of a sandwich sensor and an electrochemical pump according to an embodiment of the utility model.

Fig. 9 is a schematic structural diagram of a further electrochemical pump of a closed loop system of a sandwich sensor and an electrochemical pump according to an embodiment of the utility model.

Fig. 10 is a schematic structural diagram of a further electrochemical pump of a closed loop system of a sandwich sensor and an electrochemical pump according to an embodiment of the utility model.

FIG. 11 is a schematic diagram of the connection of electronic components of a closed loop system of a sandwich sensor and an electrochemical pump according to an embodiment of the utility model.

In the figure, 100 is an electrochemical pump, 101 is a medicine storage component, 102 is an electrochemical element, 103 is a medicine outlet, 104 is a medicine injection port, 105 is a movable plug body, 106 is a wire, 107 is a control device, 108 is a driving cavity, 109 is an electrolyte, 200 is a sandwich sensor, 201 is an enzyme layer, 202 is a working electrode, 203 is a first film layer, 204 is an insulin flow layer, 205 is a second film layer, 206 is a reference/counter electrode, and 300 is a processor.

Detailed Description

Other advantages and effects of the present utility model will become apparent to those skilled in the art from the following disclosure, which describes the embodiments of the present utility model with reference to specific examples. The utility model may be practiced or carried out in other embodiments that depart from the specific details, and the details of the present description may be modified or varied from the spirit and scope of the present utility model. It should be noted that the following embodiments and features in the embodiments may be combined with each other without conflict.

In the description of the present utility model, unless otherwise indicated, the meaning of "a plurality" is two or more; the terms "upper," "lower," "left," "right," "inner," "outer," "front," "rear," "head," "tail," and the like are used as an orientation or positional relationship based on that shown in the drawings, merely to facilitate description of the utility model and to simplify the description, and do not indicate or imply that the devices or elements referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore should not be construed as limiting the utility model. Furthermore, the terms "first," "second," "third," and the like are used for descriptive purposes only and are not to be construed as indicating or implying relative importance.

In the description of the present utility model, it should be noted that, unless explicitly specified and limited otherwise, the terms "connected," "connected," and "connected" are to be construed broadly, and may be either fixedly connected, detachably connected, or integrally connected, for example; can be mechanically or electrically connected; can be directly connected or indirectly connected through an intermediate medium. The specific meaning of the above terms in the present utility model will be understood in specific cases by those of ordinary skill in the art.

The following describes in further detail the embodiments of the present utility model with reference to the drawings and examples.

The embodiment of the utility model provides a closed loop system of a sandwich sensor and an electrochemical pump, as shown in fig. 1, wherein the closed loop system of the sandwich sensor and the electrochemical pump comprises an electrochemical pump 100 and a sandwich sensor 200;

as shown in fig. 2, the electrochemical pump 100 includes a driving part and a medicine storage part 101, the driving part being disposed inside the medicine storage part 101, the driving part including an electrochemical element 102, the electrochemical element 102 being connected to the outside of the medicine storage part 101 by a wire for receiving a preset current, the electrochemical element for generating a gas based on the preset current, the gas generating the pushing force;

as shown in fig. 3, the sandwich sensor 200 includes an enzyme layer 201, a working electrode 202, a first thin film layer 203, an insulin circulation layer 204, a second thin film layer 205, and a reference/counter electrode 206, which are sequentially connected, and the sandwich sensor 200 is connected to the medicine storage part 101 so as to pump insulin 104 stored in the medicine storage part 101 to the insulin circulation layer 204 through the medicine outlet 103 by a pushing force generated by the electrochemical element 102 through the medicine outlet 103 provided on the medicine storage part 101.

The electrochemical pump 100 and the sandwich sensor 200 are integrated to realize a closed-loop system with smaller volume, reduce the manufacturing cost, and facilitate the carrying, so as to reduce the treatment cost of diabetics and improve the use convenience of the closed-loop system.

The electrochemical pump 100 is a pump product that generates thrust based on an electrochemical reaction. As shown in fig. 2, the medicine storage part 101 in the electrochemical pump 100 is a part having a cavity in which insulin for injection is contained, and the medicine storage part 101 is provided with at least one medicine outlet 103. The driving means is arranged inside the drug storage means 101, which driving means generates a pushing force based on electrochemical principles, i.e. based on the action of a current input from a control device outside.

The medicine storage part 101 discharges the medicine liquid into the insulin circulation layer 204 through the liquid outlet hole by deformation or pressure change under the action of the pushing force generated by the driving part.

In a specific embodiment, the corresponding part of the medicine storage cavity 101 is provided with a medicine outlet 103 and a medicine injection port 104, as shown in fig. 4, insulin can be injected into the medicine storage cavity through the medicine injection port 104, and after the injection is completed, the medicine storage cavity is sealed through a movable plug 105.

The diameter of the injection port 104 is 1-5 mm, and the diameter of the liquid outlet hole is 1-5 mm. In this embodiment, the diameter of the liquid injection hole is preferably 3mm, and the diameter of the liquid outlet hole is preferably 3mm. The sizes of the liquid injection holes and the liquid outlet holes can be in the micron level.

The driving part is used for generating the driving force based on the electrochemical reaction principle. As shown in fig. 5, the electrochemical element 102 is connected to the outside of the medicine storage part 101 through a wire 106 for receiving the current outputted from the control device 107 and generating gas based on the current, whereby it generates an impetus to the medicine liquid of the medicine storage part through volume expansion. The voltage range of the driving voltage is 0.1-20V, and the driving voltage is the normal tolerance voltage of the human body and does not harm the human body. The drive voltage may be a drive current of 0.1 to 10 milliamperes.

The driving means comprises an electrochemical element 102, which electrochemical element 102 comprises at least one pair of electrodes, which electrodes are connected to the control device described above by means of wires. The electrode is a metal electrode or a composite conductive material electrode. The metal electrode can be platinum, gold, silver, copper, etc., or carbon material electrode. The electrode causes oxidation-reduction reaction or electrolysis reaction of water or other components in the liquid medicine based on the current, thereby generating corresponding gas.

The electrodes are arranged on a substrate, which may be regarded as part of an electrode, for carrying electrode material. The form of the substrate may be a planar shape, a curved shape, a zigzag shape, a microneedle shape, or a wrinkle shape. The substrate may also be in the shape of a fold, to which the electrode is attached, the electrode deforming with it when the substrate is stretched. When the material of the substrate is selected, a flexible material may be used as the substrate, a hard material such as glass may be used as the substrate, or an elastic base capable of being stretched may be used.

As can be seen from the above technical solution, the present embodiment provides a drug injection pump based on electrochemical reaction, which includes a driving component and a drug storage component. The driving component is positioned in the medicine storage component and is used for generating driving force to the inside of the medicine storage component based on an electrochemical principle by utilizing current; the medicine storage part is internally provided with medicine liquid and is used for pushing out the medicine liquid and injecting the medicine liquid to a patient under the pushing of the driving part. Because the electrochemical reaction can be generated based on an electric signal with a preset rule, the time injection of the patient can be realized by controlling the input current or voltage, thereby ensuring the stability, the intellectualization and the automation of the drug administration.

The medicine in the medicine injection pump in the application can be insulin injection, and the concentration of the medicine can be controlled between 1 and 500U/ml.

In a specific embodiment, the drive member further comprises a drive cavity 108, as shown in fig. 6. The driving cavity 108 is located inside the medicine storage component and is coated with the electrochemical element 102, an electrolyte 109 is supported inside the driving cavity, the electrolyte 109 undergoes oxidation-reduction reaction under the action of the electrochemical element 102, and the generated gas drives the driving cavity to expand, so that the driving force is generated on the medicine liquid in the medicine storage component. The electrolyte can be pure water, salt solution, etc.

The driving cavity 108 may be made of polytetrafluoroethylene, polydimethylsiloxane PDMS, polyacrylate, silica gel, rubber, latex, polyurethane, parylene, polyimide, or the like.

The electrochemical element 102 is preferably a platinum interdigital electrode comprising cross-dosed platinum electrode pads, as shown in fig. 7, the width of which is 100 μm and the distance between the platinum electrode pads is also 100 μm. The platinum interdigital electrode is connected to the outside of the drug storage part through a wire for receiving an electric current through the wire.

The overall area of the electrode in the electrochemical element is 1 square millimeter to 1 square centimeter, and the thickness thereof is generally 50 nanometers to 300 micrometers. The electrode can be manufactured by sputtering or vapor deposition mode of micro-nano processing, and the material can be platinum or gold and other materials with stable chemical properties, and can also be manufactured by a screen printing mode.

The drive chamber 108 is created by assembling a base plate and a cover plate, the edges of which are bonded together by adhesive, thereby forming a cavity therein for receiving the electrolyte and electrochemical elements. The diameter of the cover plate is preferably 8mm, and the height is preferably 7mm.

The drug storage component in this embodiment may be produced by a 3D printing process, injection molding process or other process, the material is preferably teflon material, and the thickness of the film is preferably 30 μm. The size of the medicine storage component is 20mm in diameter and 10mm in height.

In addition, the electrode in this embodiment may also adopt, besides the platinum interdigital electrode, two plate electrodes that are opposite from each other, where one plate electrode is located on the substrate and the other plate electrode is located above the substrate, as shown in fig. 8, and the other plate electrode may also be located on the inner wall of the driving cavity, as shown in fig. 9.

Alternatively, the electrodes may be two or more sets of electrodes positioned on the substrate and upstanding therefrom, as shown in FIG. 10.

The sandwich sensor 200 can be used as a component for both flowing insulin therein and detecting the concentration of glucose in tissue fluid. As shown in fig. 3, the sandwich sensor 200 comprises an enzyme layer 201, a working electrode 202, a first thin film layer 203, an insulin flow layer 204, a second thin film layer 205 and a reference/counter electrode 206 which are sequentially connected, wherein glucose in tissue fluid reacts with enzyme in the enzyme layer 201 connected with the working electrode 202, the current of the working electrode 202 changes under the voltage of a constant working electrode (relative to the reference electrode), and the concentration of glucose in the current tissue fluid can be calculated according to the current change. According to the glucose concentration in the tissue fluid, the circuit board or chip controls the voltage or current on the electrode of the electrochemical pump 100 to generate a pushing force, insulin in the drug storage part 101 is pumped into the insulin circulation layer 204, the sandwich sensor is arranged inside the human tissue, and insulin is directly injected into subcutaneous tissue fluid through the insulin circulation layer 204. The amount of insulin injected is determined based on the detected glucose concentration in the tissue fluid, e.g. a glucose concentration in the tissue fluid is a, and the amount of insulin injected is B, and the start-up time of the electrochemical pump is determined based on the basic parameters of the electrochemical pump (amount of insulin pumped out per unit time) to achieve the injection of the desired amount of insulin.

The enzyme layer 201 is specifically a structure layer to which an enzyme reacting with glucose is immobilized, and may be, for example, a structure in which a corresponding enzyme (glucose oxidase) is immobilized above the working electrode 202, and when a droplet of tissue is dropped, the enzyme layer contacts the enzyme layer 308 to cause oxidation-reduction reaction on the working electrode, thereby causing a change in current of the working electrode 202.

The insulin flow layer 204 is made of a porous polymer film made of a mesoporous polymer, which is a mixture of polyglycidyl methacrylate and polyethylene glycol or polyvinyl alcohol. By way of example only, the porous polymer film has a length of 0.5mm to 15mm, a width of 100 μm to 2mm, and a thickness of 100 μm to 1mm.

The first film layer 203 and the second film layer 205 are both made of a water impermeable film. The impermeable membrane is made of polytetrafluoroethylene, polypropylene, polyethylene, polyvinyl chloride, polyethylene terephthalate, polycarbonate, polyurethane, thermoplastic polyurethane, polyimide, glass fiber, silk fibroin, chitosan, polylactic acid, silica gel, rubber, latex, thermoplastic elastomer and perfluoroethylene propylene copolymer, and has the characteristic of being impermeable to water, so that the working electrode 202 and the reference/counter electrode 206 can separate insulin flowing in the insulin flow layer 204 while performing a tissue fluid detection function, the working electrode and the reference/counter electrode are mutually unaffected, the whole structure volume is further reduced, the patient can conveniently carry the insulin, and the manufacturing cost is lower.

Therefore, the sandwich sensor 200 in this embodiment utilizes the porous polymer membrane to have the characteristic of porous holes, so as to facilitate the penetration of the drug liquid, while the impermeable membranes on both sides of the porous polymer membrane have the characteristic of being impermeable to water, and the porous polymer membrane, the impermeable membrane, the working electrode and the reference/counter electrode together form a sandwich sensor, so that the glucose concentration in subcutaneous tissue liquid can be detected, the glucose can generate hydrogen peroxide under the action of glucose oxidase, and after the hydrogen peroxide generates electrons on the electrodes, the electric signal changes, so that the blood glucose concentration can be measured rapidly.

In a specific embodiment, as shown in fig. 11, the closed loop system further comprises a processor 300, said processor 300 being in signal connection with said working electrode 202 and said reference/counter electrode 206, said electrochemical element 102 being connected to said processor 300 outside said drug storage component 101 by means of wires. The processor 300 is configured to provide voltages to the working electrode 202, the reference/counter electrode 206, and the electrochemical element 102, in particular, by providing voltages in a manner that includes, but is not limited to, the processor 300 being coupled to a battery module. The processor 300 is also capable of receiving the current signals from the working electrode 202 and the reference/counter electrode 206 to calculate the glucose concentration in the tissue fluid based on the current signals, and to power the electrochemical element 102 (constant voltage or constant current) based on the glucose concentration, so that the electrochemical pump 100 pumps a sufficient amount of insulin into the subcutaneous tissue fluid into the insulin flow layer 204, thereby achieving automatic control of the closed-loop system.

The above embodiments are only for illustrating the present utility model, not for limiting the present utility model, and various changes and modifications may be made by one of ordinary skill in the relevant art without departing from the spirit and scope of the present utility model, and therefore, all equivalent technical solutions are also within the scope of the present utility model, and the scope of the present utility model is defined by the claims.

Claims

1. A closed loop system of a sandwich sensor and an electrochemical pump, comprising the electrochemical pump and the sandwich sensor;

the electrochemical pump comprises a driving part and a medicine storage part, wherein the driving part and the medicine storage part are arranged in the same cavity, the driving part comprises an electrochemical element, the electrochemical element is connected to the outside of the medicine storage part through a wire and is used for receiving preset current, the electrochemical element is used for generating gas based on the preset current, and the gas generates pushing force to push a film between the driving part and the medicine storage part to expand so as to push medicine injection;

the sandwich sensor comprises an enzyme layer, a working electrode, a first film layer, an insulin circulation layer, a second film layer and a reference/counter electrode which are sequentially connected, wherein the sandwich sensor is connected with a medicine outlet arranged on the medicine storage component, and insulin stored in the medicine storage component is pumped into the insulin circulation layer through the medicine outlet by virtue of thrust generated by the electrochemical element.

2. The closed loop system of a sandwich sensor and electrochemical pump of claim 1 wherein said insulin flow-through layer is fabricated from a porous polymer film fabricated from a mesoporous polymer.

3. The closed loop system of a sandwich sensor and electrochemical pump of claim 1 wherein said first membrane layer and said second membrane layer are each a water impermeable membrane.

4. The closed loop system of a sandwich sensor and electrochemical pump of claim 1 wherein the electrochemical element is a metal electrode, a carbon electrode, or a composite conductive material electrode.

5. The closed loop system of a sandwich sensor and electrochemical pump of claim 1 wherein the electrochemical element is an interdigitated electrode, a flat plate electrode, or a cylindrical electrode.

6. The closed loop system of a sandwich sensor and electrochemical pump of claim 5 wherein the substrate of the interdigitated electrode is a rigid substrate, a flexible substrate, or a stretchable elastomeric substrate.

7. The closed loop system of a sandwich sensor and an electrochemical pump of claim 5 wherein said drive member further comprises a drive cavity encasing said electrochemical element, said drive cavity and said drug storage member being disposed within the same cavity;

8. The closed loop system of a sandwich sensor and electrochemical pump of claim 7 wherein said electrolyte is pure water or a salt solution.

9. The closed loop system of a sandwich sensor and electrochemical pump of claim 5 further comprising a processor, said working electrode and said reference/counter electrode being signally connected to said processor, said electrochemical element being wired to said processor external to said drug storage component.

10. The closed loop system of a sandwich sensor and electrochemical pump of claim 9 wherein said processor is disposed outside of said drug storage component.