WO2023174441A2

WO2023174441A2 - Test patch, test system, and method for testing physiological substance by using test patch

Info

Publication number: WO2023174441A2
Application number: PCT/CN2023/089627
Authority: WO
Inventors: 富佳伟; 杨玲; 陈毅豪; 杨芷炎; 陈君剑
Original assignee: 杭州柔谷科技有限公司
Priority date: 2023-04-20
Filing date: 2023-04-20
Publication date: 2023-09-21
Also published as: WO2023174441A3

Abstract

The present application relates to a test patch, a test system, and a method for testing a physiological substance by using a test patch. The test patch comprises a first sticker and a flexible electrode film, wherein the flexible electrode film comprises a flexible substrate, and a first electrode group and a second electrode group, which are arranged on the same side of the flexible substrate, and the first electrode group and the second electrode group are used for testing a subcutaneous physiological substance; a side surface of the first sticker is fitted to the side surface of the flexible substrate that is provided with the first electrode group and the second electrode group, the first sticker is provided with a first through hole and a second through hole, and the positions of the first electrode group and the second electrode group respectively correspond to the positions of the first through hole and the second through hole; and the flexible substrate is provided with liquid injection holes, which are respectively in communication with the first through hole and the second through hole. The technical solution in the present application can be used for realizing non-invasive testing of a subcutaneous physiological substance, and can reduce testing costs.

Description

Detection patch, detection system and method of detecting physiological substances using detection patch

Technical field

The present application belongs to the technical field of physiological substance detection, and in particular relates to a detection patch, a detection system and a method of detecting physiological substances using the detection patch.

Background technique

Subcutaneous physiological substances are an important part of the human body, and the concentration of subcutaneous physiological substances directly reflects the health level of the human body. Taking blood sugar as an example, when the human body's fasting blood sugar concentration is higher than the normal value, it reflects the human body's risk of developing diabetes.

During the diagnosis or treatment of patients with diabetes, it is often necessary to detect blood sugar concentration. Commonly used blood sugar testing methods include non-invasive testing, minimally invasive testing, and invasive testing. At present, invasive detection methods are low-cost, but have strong pain. Minimally invasive detection methods are more expensive and may cause slight pain. Non-invasive detection methods, such as optics, bioimpedance spectroscopy, metabolic heat, etc., are painless. sense, but the detection cost is higher.

How to achieve non-invasive detection of subcutaneous physiological substances and reduce detection costs has become an urgent problem to be solved.

Technical solutions

In view of the above technical problems, this application provides a detection patch, a detection system and a method of detecting physiological substances using the detection patch to achieve non-invasive detection of subcutaneous physiological substances and reduce detection costs.

This application provides a detection patch. The detection patch includes a first adhesive patch and a flexible electrode film: the flexible electrode film includes a flexible base, a first electrode group and a second electrode group. The first electrode group and the second electrode group are arranged on the same side of the flexible base, the first electrode group and the second electrode group are used to detect subcutaneous physiological substances; one side surface of the first adhesive patch is in contact with the The side surface of the flexible substrate provided with the first electrode group and the second electrode group is attached, and a first through hole and a second through hole are opened on the first adhesive. The first electrode group and the position of the second electrode group corresponds to the position of the first through hole and the second through hole respectively; the flexible base is provided with a position corresponding to the first through hole and the second through hole respectively. Connected injection hole.

In one embodiment, the detection patch further includes a second adhesive patch, one side surface of the second adhesive patch is attached to a side surface of the flexible base facing away from the first adhesive patch: A third through hole and a fourth through hole are provided on the second adhesive tape. The third through hole is connected to the first through hole through the liquid injection hole. The fourth through hole is connected to the liquid injection hole through the liquid injection hole. The second through holes are connected.

In one embodiment, the first electrode group, the first through hole on the first adhesive, and the third through hole on the second adhesive are arranged concentrically; the second electrode group, the The second through hole on the first adhesive tape and the fourth through hole on the second adhesive tape are arranged concentrically.

In one embodiment, the size of the first through hole on the first adhesive is larger than the size of the first electrode group; the size of the second through hole on the first adhesive is larger than the size of the second electrode. The size of the group; the size of the third through hole on the second adhesive tape is greater than or equal to the size of the first through hole on the first adhesive tape; the size of the fourth through hole on the second adhesive tape Greater than or equal to the size of the second through hole on the first adhesive.

In one embodiment, the detection patch further includes a release film and a waterproof film; the release film is attached to a side surface of the first adhesive patch facing away from the flexible base; the waterproof film Attached to the side surface of the second adhesive patch facing away from the flexible base, for laminating and attaching the first adhesive patch, the flexible electrode film and the second adhesive patch to the body surface .

In one embodiment, the first electrode group includes a first working electrode, a first pair of electrodes and a first reference electrode, and the first pair of electrodes and the first reference electrode surround the first working electrode. Set, the surface of the first working electrode is provided with an activated enzyme; the second electrode group includes a second working electrode, a second counter electrode and a second reference electrode, the second counter electrode and the second reference electrode It is arranged around the second working electrode, and the activating enzyme is arranged on the surface of the second working electrode.

In one embodiment, the injection hole is provided in an area of the flexible substrate corresponding to the first through hole of the first adhesive tape, and is provided in an inner area or outer periphery of the first electrode group; The liquid injection hole is provided in an area of the flexible substrate corresponding to the second through hole of the first adhesive tape, and is provided in an inner area or outer periphery of the second electrode group.

This application also provides a method for detecting physiological substances by using the above detection patch, including: step S1, attaching the detection patch to the body surface, so that the first through hole on the first adhesive layer and the third An electrode group and the body surface of the corresponding area form a first liquid storage space for storing electrolyte. The second through hole on the first adhesive, the second electrode group and the body surface of the corresponding area form a first liquid storage space for storing electrolyte. The second liquid storage space of the liquid; Step S2, inject the electrolyte into the first liquid storage space and the second liquid storage space through the liquid injection hole; Step S3, inject the electrolyte into the first electrode group and the second liquid storage space. A constant current path is formed between the second electrode groups, so that subcutaneous physiological substances are extracted into the electrolyte in the first liquid storage space and the second liquid storage space; step S4, disconnect the constant current path, And forming a constant potential path in the first electrode group or the second electrode group, so that the first electrode group or the second electrode group detects the subcutaneous physiological substance and generates an electrochemical signal; Step S5: Determine the concentration of the subcutaneous physiological substance according to the electrochemical signal.

In one embodiment, before forming a constant current path between the first electrode group and the second electrode group, the method further includes: applying a preset voltage to the first electrode group and/or the The second electrode group performs baseline current detection to stabilize the initial current in the electrolyte.

This application also provides a detection system. The detection system includes the above-mentioned detection patch and processing equipment; the detection patch is connected to the processing equipment; the processing equipment is used to perform steps S3-S5 in the above method. , and before forming a constant current path between the first electrode group and the second electrode group, conduct a baseline current test on the first electrode group and/or the second electrode group at a preset voltage. Detect the step to stabilize the initial current in the electrolyte.

The application provides a detection patch, a detection system and a method for detecting physiological substances using the detection patch, which have the following beneficial effects:

1. The first electrode group and the second electrode group for detecting subcutaneous physiological substances, which are arranged on the same side of the flexible substrate, can be used to non-invasively extract and detect subcutaneous physiological substances, thereby achieving non-invasive detection of subcutaneous physiological substances;

2. The detection patch has a simple structure and is easy to process, which can reduce the cost of detecting subcutaneous physiological substances.

Description of the drawings

Figure 1 is a schematic structural diagram of a detection patch provided in Embodiment 1 of the present application.

Figure 2 is a schematic structural diagram of a flexible electrode film provided in Embodiment 1 of the present application.

Figure 3 is a schematic diagram of the effect of attaching the detection patch to the body surface according to Embodiment 1 of the present application.

Figure 4 is a structural cross-sectional view of a detection patch attached to the body surface provided in Embodiment 1 of the present application.

Figure 5 is a schematic diagram of the effect of injecting electrolyte into the detection patch according to Embodiment 1 of the present application.

Figure 6 is a schematic flowchart of a method for detecting physiological substances using a detection patch provided in Embodiment 2 of the present application.

Figure 7 is a schematic structural diagram of a detection system provided in Embodiment 3 of the present application.

Embodiments of the invention

Specific implementations of the present application will be described in further detail below with reference to the accompanying drawings and examples. The following examples are used to illustrate the present application but are not intended to limit the scope of the present application.

Figure 1 is a schematic structural diagram of a detection patch provided in Embodiment 1 of the present application. Figure 2 is a schematic structural diagram of a flexible electrode film provided in Embodiment 1 of the present application. As shown in Figures 1 and 2, the detection patch T of the present application includes a first adhesive patch 1 and a flexible electrode film 2.

The flexible electrode film 2 includes a flexible substrate 20, a first electrode group 2a and a second electrode group 2b. The first electrode group 2a and the second electrode group 2b are arranged on the same side of the flexible substrate 20. The first electrode group 2a and the second electrode group 2a are arranged on the same side of the flexible substrate 20. Group 2b is used to detect subcutaneous physiological substances. One side surface of the first adhesive tape 1 is attached to the side surface of the flexible substrate 20 provided with the first electrode group 2a and the second electrode group 2b. The first adhesive tape 1 is provided with a first through hole 11 and a second electrode group 2b. The positions of the through hole 12, the first electrode group 2a and the second electrode group 2b correspond to the positions of the first through hole 11 and the second through hole 12 respectively. The flexible base 20 is provided with liquid injection holes 21 that are respectively connected with the first through hole 11 and the second through hole 12 .

Please refer to Figure 3 and Figure 4, and attach the detection patch T to the body surface 5 of the detection area, such as the arm, abdomen and other detection areas. The first through hole 11 on the first adhesive tape 1 (please refer to Figure 1), the first electrode group 2a on the flexible electrode film 2 (please refer to Figure 2) and the body surface 5 of the corresponding area form a hole for storing electrolyte. The first liquid storage space A1, the second through hole 12 on the first adhesive patch 1 (please combine it with Figure 1), the second electrode group 2b on the flexible electrode film 2 (please combine it with Figure 2) and the body surface 5 of the corresponding area A second liquid storage space A2 for storing electrolyte is formed.

As shown in Figure 5, a syringe 6 is used to inject electrolyte into the first liquid storage space A1 and the second liquid storage space A2 through the injection hole 21; the processing equipment is used to inject electrolyte into the first electrode group 2a (please refer to Figure 2) and A constant current path is formed between the second electrode group 2b (please refer to Figure 2), so that subcutaneous physiological substances are extracted into the electrolyte in the first liquid storage space A1 and the second liquid storage space A2, and then the constant current path is disconnected , and form a constant potential path in the first electrode group 2a (please associate with Figure 2) or the second electrode group 2b (please associate with Figure 2), so that the first electrode group 2a (please associate with Figure 2) or the second electrode group 2b (please refer to Figure 2) detects subcutaneous physiological substances to generate electrochemical signals, and the processing equipment determines the concentration of subcutaneous physiological substances based on the electrochemical signals.

The detection patch provided in Embodiment 1 of the present application uses a flexible base, which reduces the elastic modulus of the detection patch, improves the adhesion effect between the detection patch and the body surface skin, prevents skin dents, and ensures that the first working electrode group, The second working electrode group is in full contact with the body surface skin, which can improve the detection accuracy of subcutaneous physiological substances. Through the first through hole opened on the first adhesive tape corresponding to the position of the first electrode group, the second through hole opened on the first adhesive tape corresponding to the position of the second electrode group, and the first through hole opened on the flexible substrate corresponding to the first electrode group. When the through hole and the second through hole are connected to the injection hole, when the first adhesive tape is attached to the body surface, the first through hole on the first adhesive tape, the first electrode group and the body surface in the corresponding area can form a liquid injection hole. In the first liquid storage space for storing the electrolyte, the second through hole on the first adhesive layer, the second electrode group and the body surface of the corresponding area can form a second liquid storage space for storing the electrolyte. The first liquid storage space The electrolyte stored in the space and the second liquid storage space can promote the diffusion of subcutaneous physiological substances and improve the detection efficiency of subcutaneous physiological substances. Through the first electrode group and the second electrode group for detecting subcutaneous physiological substances, which are arranged on the same side of the flexible base, and with the help of the processing equipment to control the channels of the first electrode group and the second electrode group and analyze the electrode detection data, it is possible to Realize non-invasive detection of subcutaneous physiological substances. In addition, the detection patch has a simple structure and is easy to process, which can reduce the cost of detecting subcutaneous physiological substances.

Optionally, subcutaneous physiological substances include subcutaneous glucose molecules, lactic acid molecules, sodium ions, potassium ions, etc. The first adhesive patch 1 is made of a low-modulus square base material such as polyethylene terephthalate, thermoplastic polyurethane, and silicone, and is made through laser cutting, stamping, mold forming and other processes. It has a first pass inside. The thickness of the waterproof material of the hole 11 and the second through hole 12 is 0.2mm-1mm. The flexible substrate 20 includes low-modulus materials such as polyethylene terephthalate, thermoplastic polyurethane, polyimide, and silicone, and its thickness is less than 80 μm. One side surface of the first adhesive tape 1 is bonded to the side surface of the flexible substrate 20 on which the first electrode group 2 a and the second electrode group 2 b are provided by pressure-sensitive adhesive. The liquid injection hole 21 is made by laser cutting, stamping and other processes on the flexible substrate 20, and its diameter is 0.5mm-1.5mm.

In one embodiment, please continue to refer to FIGS. 1 and 2 , the detection patch T also includes a second adhesive patch 3 , one side surface of the second adhesive patch 3 and a side of the flexible substrate 20 facing away from the first adhesive patch 1 Side surface attached. The second adhesive tape 3 is provided with a third through hole 31 and a fourth through hole 32. The third through hole 31 is connected to the first through hole 11 through the liquid injection hole 21, and the fourth through hole 32 is connected to the first through hole 11 through the liquid injection hole 21. The two through holes 12 are connected.

Optionally, the second adhesive patch 3 is an internal opening made of a low-modulus square base material such as polyethylene terephthalate, thermoplastic polyurethane, or silicone through processes such as laser cutting, stamping, and mold forming. The thickness of the waterproof material with the third through hole 31 and the fourth through hole 32 is 0.05mm-0.5mm, preferably, the thickness is 0.1mm-0.3mm. One side surface of the second adhesive tape 3 is bonded to a side surface of the flexible substrate 20 facing away from the first adhesive tape 1 through pressure-sensitive adhesive.

In one embodiment, the first electrode group 2a, the first through hole 11 on the first adhesive tape 1, and the third through hole 31 on the second adhesive tape 3 are concentrically arranged, and the second electrode group 2b, the first adhesive tape The second through hole 12 on the second adhesive tape 1 and the fourth through hole 32 on the second adhesive tape 3 are concentrically arranged.

In one embodiment, the size of the first through hole 11 on the first adhesive tape 1 is larger than the size of the first electrode group 2a, and the size of the second through hole 12 on the first adhesive tape 1 is larger than the size of the second electrode group 2b. Size; the size of the third through hole 31 on the second adhesive patch 3 is greater than or equal to the size of the first through hole 11 on the first adhesive patch 1, and the size of the fourth through hole 32 on the second adhesive patch 3 is greater than or equal to It is equal to the size of the second through hole 12 on the first adhesive tape 1 .

For example, when the shapes of the first electrode group 2a and the second electrode group 2b are circular, the shapes of the first through hole 11, the second through hole 12, the third through hole 31, and the fourth through hole 32 are also circular. Round. When the first adhesive tape 1 and the second adhesive tape 3 are respectively attached to the flexible substrate 20, the first electrode group 2a, the first through hole 11 on the first adhesive tape 1, and the third through hole on the second adhesive tape 3 The centers of the holes 31 are on the same straight line, and the centers of the second electrode group 2b, the second through hole 12 on the first adhesive tape 1, and the fourth through hole 32 on the second adhesive tape 3 are on the same straight line. In addition, in order to allow the first electrode group 2a and the second electrode group 2b to fully contact the electrolyte, the diameter of the first through hole 11 on the first adhesive tape 1 is larger than the diameter of the first electrode group 2a. The diameter of the second through hole 12 is greater than the diameter of the second electrode group 2b; the diameter of the third through hole 31 on the second adhesive tape 3 is greater than or equal to the diameter of the first through hole 11 on the first adhesive tape 1. The diameter of the fourth through hole 32 on the adhesive tape 3 is greater than or equal to the diameter of the second through hole 12 on the first adhesive tape 1 .

In one embodiment, the detection patch T also includes a release film 101 and a waterproof film 4. The release film 101 is attached to the side surface of the first adhesive patch 1 facing away from the flexible base 20, and the waterproof film 4 is attached to The side surface of the second adhesive patch 3 facing away from the flexible base 2 is used to laminate and attach the first adhesive patch 1, the flexible electrode film 2 and the second adhesive patch 3 to the body surface.

Optionally, the release film 101 includes polyethylene terephthalate, polyethylene, or other films that are easy to peel off from the side surface of the first adhesive tape 1 facing away from the flexible substrate 20 . The waterproof membrane 4 includes polyurethane, non-woven fabric and other waterproof and sweat-resistant materials, has good stickiness and elasticity, and can be attached to the side surface of the second adhesive patch 3 facing away from the flexible base 2, and connects the first adhesive patch 1, The flexible electrode film 2 and the second adhesive tape 3 are stacked and attached to the body surface.

Please continue to refer to Figure 2. The first electrode group 2a includes a first pair of electrodes 22, a first working electrode 23 and a first reference electrode 24. The first pair of electrodes 22 and the first reference electrode 24 are arranged around the first working electrode 23. , the surface of the first working electrode 23 is provided with an activated enzyme.

The second electrode group 2b includes a second counter electrode 22', a second working electrode 23' and a second reference electrode 24'. The second counter electrode 22' and the second reference electrode 24' are arranged around the second working electrode 23'. , the surface of the second working electrode 23' is provided with an activated enzyme.

Optionally, the first electrode group 2 a and the second electrode group 2 b are symmetrically distributed on the flexible substrate 20 . Wherein, the first working electrode 23 and the second working electrode 24 have a circular or annular structure. The first pair of electrodes 22 and the first reference electrode 24 form a ring-shaped structure surrounding the first working electrode 23. The first pair of electrodes 22 is the main part of the ring-shaped structure and is used to form a polarization loop with the first working electrode 23. The first working electrode 23 is allowed to pass current, and the remaining part of the annular structure is the first reference electrode 24, which is used to provide and maintain a fixed position during the detection of subcutaneous physiological substances based on the electrochemical signals of the first electrode group 2a. the reference potential. Similarly, the second pair of electrodes 22' and the second reference electrode 24' form an annular structure surrounding the second working electrode 23'. The second pair of electrodes 22' is the main part of the annular structure and is used to communicate with the second working electrode. 23' constitutes a polarization loop, so that the second working electrode 23' has current flowing through it. The remaining part of the annular structure is the second reference electrode 24', which is used to detect subcutaneous physiology according to the electrochemical signal of the second electrode group 2b. During the process of matter, a fixed reference potential is provided and maintained.

Optionally, the first pair of electrodes 22 and the second pair of electrodes 22' include at least one of carbon, silver, and silver chloride, and are doped with graphene and/or carbon nanotubes. The first working electrode 23 and the second working electrode 23' include platinum, Prussian blue, other materials that can catalyze the oxidation reaction of subcutaneous physiological substances, etc., and activating enzymes are provided on their surfaces. The first reference electrode 24 and the second reference electrode 24' include at least one of silver and silver chloride.

Optionally, the first pair of electrodes 22 and the second pair of electrodes 22' are made of at least one of carbon paste, silver paste, and silver chloride paste, doped with conductive paste such as graphene and/or carbon nanotubes. , produced through screen printing process. The first working electrode 23 and the second working electrode 23' are made of a slurry containing platinum, Prussian blue, and other slurries that can catalyze the oxidation reaction of subcutaneous physiological substances through a screen printing process, and then the activation enzyme solution and pentylene glycol The aldehyde solution is mixed evenly and then applied to the surfaces of the first working electrode 23 and the second working electrode 23'. After drying and solidifying, an activating enzyme is provided on the surfaces of the first working electrode 23 and the second working electrode 23', wherein, glutarin The aldehyde is used to cross-link the activated enzyme with the surfaces of the first working electrode 23 and the second working electrode 23'. The first reference electrode 24 and the second reference electrode 24' are made of at least one of silver paste and silver chloride paste through a screen printing process.

In one embodiment, the flexible electrode film 2 is provided with a conductor set 25. The conductor set 25 includes a lead part and a non-lead part, and the non-lead part is sealed by an insulating layer. The first pair of electrodes 22, the first working electrode 23 and the first reference electrode 24 are respectively connected to the non-lead part of the lead set 25, and are connected to the processing equipment through the lead part of the lead set 25, so that the processing equipment is connected according to the first The electrochemical information of the electrode group 2a determines the concentration of physiological substances under the skin. The second pair of electrodes 22', the second working electrode 23' and the second reference electrode 24' are respectively connected to the non-lead part of the lead set 25, and are connected to the processing equipment through the lead part of the lead set 25, so that the processing equipment Based on the electrochemical information of the second electrode group 2b, the concentration of subcutaneous physiological substances is determined. Optionally, the wire group 25 includes at least one of carbon, silver, and silver chloride, is doped with graphene and/or carbon nanotubes, and is made of at least one of carbon paste, silver paste, and silver chloride paste. A kind of slurry, doped with conductive slurry such as graphene or carbon nanotubes, and produced through screen printing process.

In one embodiment, the liquid injection hole 21 is provided in an area of the flexible substrate 20 corresponding to the first through hole 11 of the first adhesive tape 1, and is provided in an inner area of the first electrode group 2a, or the first electrode group 2a The outer periphery of the flexible substrate 20 corresponds to the second through hole 12 of the first adhesive tape 1 and is disposed in the inner area of the second electrode group 2b or the outer periphery of the second electrode group 2b.

Optionally, the inner area of the first electrode group 2a includes areas between the first pair of electrodes 22 and the first working electrode 23, the interior of the first working electrode 23, and other areas. The inner region of the second electrode group 2b includes the region between the second counter electrode 22' and the second working electrode 23', the interior of the second working electrode 23', and other areas.

The detection patch provided in Embodiment 1 of the present application is composed of a low-modulus first patch, a second patch and a flexible electrode film. It has a low elastic modulus, so that the detection patch can be conformally attached to The body surface prevents the surface skin from being sunken and ensures that the first electrode group and the second electrode group are in full contact with the body surface skin, which can improve the detection accuracy and effectiveness of subcutaneous physiological substances.

In addition, through the concentrically arranged first electrode group, the first through hole on the first adhesive, the third through hole on the second adhesive, and the concentrically arranged second electrode group, the second through hole on the first adhesive The through hole and the fourth through hole on the second adhesive tape. When the detection patch is attached to the body surface, the first through hole on the first adhesive tape, the first electrode group and the body surface in the corresponding area can form a In the first storage space for storing electrolyte, the second through hole on the first adhesive tape, the second electrode group and the body surface of the corresponding area can form a second liquid storage space for storing electrolyte. The second adhesive tape The third through hole, the first electrode group and the waterproof membrane in the corresponding area can form a third liquid storage space for storing electrolyte, and the fourth through hole, the second electrode group and the corresponding area on the second adhesive The waterproof membrane can form a fourth liquid storage space for storing electrolyte. Through the liquid injection holes opened on the flexible substrate and connected to the first through hole, the second through hole, the third through hole and the fourth through hole respectively, Sufficient electrolyte can be stored in the first liquid storage space and the second liquid storage space, which can promote the diffusion of subcutaneous physiological substances and improve the detection efficiency and linearity of subcutaneous physiological substances. When the electrolyte in the first liquid storage space and the second liquid storage space is insufficient, under the action of gravity, the third liquid storage space can replenish electrolyte to the first liquid storage space, and the fourth liquid storage space can replenish electrolyte to the second liquid storage space. The liquid space is replenished with electrolyte, which can ensure the detection efficiency and linearity of subcutaneous physiological substances.

Figure 6 is a schematic flowchart of a method for detecting physiological substances using the above detection patch provided in Embodiment 2 of the present application. As shown in Figure 6, the method of using the above-mentioned detection patch to detect physiological substances in this application includes but is not limited to the following steps:

Step S1: Attach the detection patch to the body surface, so that the first through hole on the first adhesive tape, the first electrode group and the body surface of the corresponding area form a first liquid storage space for storing electrolyte. The second through hole on the adhesive tape, the second electrode group and the body surface of the corresponding area form a second liquid storage space for storing electrolyte;

Step S2: Inject electrolyte into the first liquid storage space and the second liquid storage space through the liquid injection hole;

Step S3: Form a constant current path between the first electrode group and the second electrode group, so that subcutaneous physiological substances are extracted into the electrolyte in the first liquid storage space and the second liquid storage space;

Step S4: Disconnect the constant current path and form a constant potential path in the first electrode group or the second electrode group, so that the first electrode group or the second electrode group detects subcutaneous physiological substances and generates electrochemical signals;

Step S5: Determine the concentration of subcutaneous physiological substances based on the electrochemical signal.

Embodiment 2 of the present application provides a method for detecting physiological substances using the above-mentioned detection patch. By using a detection-side patch with a flexible base to detect subcutaneous physiological substances, the adhesion effect between the detection patch and the body surface skin can be improved, and the skin can be prevented from sunken. Ensuring that the first working electrode group and the second working electrode group are in full contact with the surface skin can improve the detection accuracy of subcutaneous physiological substances. When the detection patch is attached to the body surface, the electrolyte stored in the first liquid storage space and the second liquid storage space can promote the diffusion of subcutaneous physiological substances and improve the detection efficiency of subcutaneous physiological substances. By forming a constant current path and a constant potential path between the first electrode group and the second electrode group for detecting subcutaneous physiological substances that are disposed on the same side of the flexible substrate, non-invasive detection of subcutaneous physiological substances can be achieved. In addition, the above-mentioned detection patch has a simple structure and is easy to process. Using the above-mentioned detection patch to detect physiological substances can reduce detection costs.

As shown in Figure 3, peel off the release film 101 (please refer to Figure 1) from the detection patch T, and use the waterproof film 4 to stack the first adhesive tape 1, the flexible electrode film 2 and the second adhesive tape 3. 5 on the body surface of the testing area, such as arms, abdomen and other testing areas. As shown in Figure 4, the first through hole 11 on the first adhesive tape 1 (please refer to Figure 1), the first electrode group 2a on the flexible electrode film 2 (please refer to Figure 2) and the body surface 5 in the corresponding area are formed. The first liquid storage space A1 for storing electrolyte, the second through hole 12 on the first adhesive tape 1 (please combine it with Figure 1), the second electrode group 2b on the flexible electrode film 2 (please combine it with Figure 2) and The body surface 5 of the corresponding area forms a second liquid storage space A2 for storing electrolyte. The third through hole 31 on the second adhesive tape 3 (please refer to Figure 1), the first electrode group 2a on the flexible electrode film 2 (please refer to Figure 2) and the waterproof film 4 in the corresponding area form a hole for storing electrolyte. The third liquid storage space B1, the fourth through hole 32 on the second adhesive tape 3 (please combine it with Figure 1), the second electrode group 2b on the flexible electrode film 2 (please combine it with Figure 2) and the waterproof membrane 4 in the corresponding area A fourth liquid storage space B2 for storing electrolyte is formed. The first liquid storage space A1 is connected to the third liquid storage space B1 through the liquid injection hole 21 , and the second liquid storage space A2 is connected to the fourth liquid storage space B2 through the liquid injection hole 21 . As shown in Figure 5, a syringe 6 is used to pierce the waterproof membrane 4, and electrolyte is injected into the third liquid storage space B1 and the fourth liquid storage space B2. Under the action of gravity, the electrolyte in the third liquid storage space B1 will pass through The liquid injection hole 21 flows to the first liquid storage space A1, and the electrolyte in the fourth liquid storage space B2 will flow to the second liquid storage space A2 through the liquid injection hole 21, so that the first liquid storage space A1 and the second liquid storage space A2 is filled with electrolyte, and when the electrolyte in the first liquid storage space A1 and the second liquid storage space A2 is insufficient, electrolyte is replenished into the first liquid storage space A1 and the second liquid storage space A2. In actual implementation, the syringe 6 can also directly inject the electrolyte into the first liquid storage space A1 and the second liquid storage space A2 through the liquid injection hole 21 .

A constant current of 100 μA to 500 μA is applied to the first pair of electrodes and the second pair of electrodes. The first pair of electrodes serves as the anode and the second pair of electrodes serves as the cathode. The current flows through the first pair of electrodes through the electrolyte in the first liquid storage space A1 Enters the skin, and then flows back from the electrolyte in the second liquid storage space A2 to the second pair of electrodes, forming a constant current path for subcutaneous physiological substances. Subcutaneous glucose molecules, lactic acid molecules, sodium ions, potassium ions and other subcutaneous physiological substances are Under the action of electric current, it is extracted into the first liquid storage space A1 and the second liquid storage space A2 to wait for detection. The time for extracting subcutaneous physiological substances is kept at 3min-30min.

Disconnect the constant current path, form a constant potential path between the first working electrode and the first counter electrode, or the second working electrode and the second counter electrode, and extract it into the first liquid storage space A1 and the second liquid storage space A2 The subcutaneous physiological substances undergo an enzymatic reaction with the activation enzyme provided on the surface of the first working electrode or the second working electrode to form an electrochemical signal, and the concentration of the subcutaneous physiological substances can be determined based on the electrochemical signal.

It is worth mentioning that for reproductive hormones that need to be detected using detection kits or professional instruments, such as luteinizing hormone, estradiol, etc., the detection patch provided by this application can also be used to extract subcutaneous reproductive hormones into the first storage. into the liquid space A1 and the second liquid storage space A2, and then use a detection kit or professional instrument to detect the subcutaneous reproductive hormones extracted into the first liquid storage space A1 and the second liquid storage space A2 to determine the subcutaneous reproductive hormones hormone concentration.

In one embodiment, before forming a constant current path between the first electrode group and the second electrode group, the method further includes:

Under a preset voltage, baseline current detection is performed on the first electrode group and/or the second electrode group to stabilize the initial current in the electrolyte.

Optionally, after the detection patch is attached to the body surface, the first electrode group and the second electrode group are subjected to constant potential polarization treatment, that is, the first pair of electrodes and the first pair of electrodes in the electrolyte are subjected to a preset voltage. The working electrode, and/or the second pair of electrodes and the second working electrode perform baseline current detection to stabilize the initial current in the electrolyte.

Optionally, the electrolyte is a phosphate buffered saline solution, the main components of which include disodium hydrogen phosphate, potassium dihydrogen phosphate, sodium chloride, potassium chloride, etc., used to dissolve subcutaneous physiological substances and prevent subcutaneous physiological substances from adhering to the first The electrode group and the second electrode group.

Embodiment 2 of the present application provides a method for detecting physiological substances using the above-mentioned detection patch. Before forming a constant current path between the first electrode group and the second electrode group, the first electrode group and the second electrode group are tested at a preset voltage. /Or the second electrode group performs baseline current detection to stabilize the initial current in the electrolyte, which can improve the detection accuracy of subcutaneous physiological substances.

Figure 7 is a schematic structural diagram of a detection system provided in Embodiment 3 of the present application. As shown in Figure 7, the detection system of this application includes the above-mentioned detection patch T and processing equipment K;

Among them, the detection patch T is connected to the processing equipment K;

The processing device K is used to perform steps S3-S5 in the method of detecting physiological substances using the above-mentioned detection patch T as described above, and before forming a constant current path between the first electrode group and the second electrode group, preset Under the voltage, the step of performing baseline current detection on the first electrode group and/or the second electrode group to stabilize the initial current in the electrolyte.

In one embodiment, the detection patch T is connected to the processing device K in a plug-in manner, and the processing device K is a wearable electronic device.

Optionally, before detecting subcutaneous physiological substances, the processing device K is fixed to the detection site, such as the arm, abdomen, etc., through the elastic band S, and then the detection patch T is attached to the body surface of the detection site. Turn on the power switch K1 on the processing equipment K. The embedded program built into the processing equipment K will automatically detect the connection status of the patch T and the processing equipment K. When the detection patch T and the processing equipment K are successfully connected, it will automatically detect the connection status of the patch T and the processing equipment K. The first electrode group and the second electrode group are subjected to constant potential polarization treatment, that is, the first pair of electrodes and the first working electrode, or the second pair of electrodes and the second working electrode in the electrolyte are subjected to a baseline current at a preset voltage. Detection is a step to stabilize the initial current in the electrolyte. After completing the baseline current detection, the prompt light K2 on the processing equipment K flashes. Press the button K3 on the processing device K. The processing device K performs steps S3-S5 in the method of detecting physiological substances using the above-mentioned detection patch T as described above. The processing device K transmits the concentration of subcutaneous physiological substances through wireless/wired communication. Transmit to server or mobile terminal.

The detection system provided in Embodiment 3 of the present application uses a processing device to collect the electrochemical signals of the first working electrode and the second working electrode for detecting subcutaneous physiological substances provided on the flexible base of the above-mentioned detection patch, and performs the detection according to the electrochemical The signal determines the concentration of subcutaneous physiological substances, enabling non-invasive detection of subcutaneous physiological substances, reducing detection costs, and improving detection efficiency and detection accuracy. In addition, the processing equipment is a wearable electronic device, which can meet wearable detection needs.

In this article, unless otherwise clearly stated and limited, the terms "installation", "connection" and "connection" should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral connection; it can be It can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediary, or it can be an internal connection between two components. For those of ordinary skill in the art, the specific meanings of the above terms can be understood on a case-by-case basis.

As used herein, the terms "includes," "comprises," or any other variation thereof are intended to cover a non-exclusive inclusion of elements other than those listed and may also include other elements not expressly listed.

The above are only specific embodiments of the present application, but the protection scope of the present application is not limited thereto. Any person familiar with the technical field can easily think of changes or substitutions within the technical scope disclosed in the present application. should be covered by the protection scope of this application. Therefore, the protection scope of this application should be subject to the protection scope of the claims.

Claims

A detection patch, characterized in that the detection patch includes a first adhesive patch and a flexible electrode film;

The flexible electrode film includes a flexible substrate, a first electrode group and a second electrode group. The first electrode group and the second electrode group are arranged on the same side of the flexible substrate. The first electrode group and the The second electrode group is used to detect subcutaneous physiological substances;

One side surface of the first adhesive tape is attached to a side surface of the flexible base where the first electrode group and the second electrode group are provided, and a first through hole is opened on the first adhesive layer. hole and a second through hole, the positions of the first electrode group and the second electrode group respectively correspond to the positions of the first through hole and the second through hole;

The flexible base is provided with liquid injection holes that are respectively connected with the first through hole and the second through hole.
The detection patch according to claim 1, wherein the detection patch further includes a second adhesive patch, one side surface of the second adhesive patch and a surface of the flexible base facing away from the first adhesive patch. One side of the sticker is attached to the surface:

A third through hole and a fourth through hole are provided on the second adhesive tape. The third through hole is connected to the first through hole through the liquid injection hole. The fourth through hole passes through the liquid injection hole. connected to the second through hole.
The detection patch according to claim 2, characterized in that the first electrode group, the first through hole on the first adhesive tape, and the third through hole on the second adhesive tape are arranged concentrically;

The second electrode group, the second through hole on the first adhesive tape, and the fourth through hole on the second adhesive tape are arranged concentrically.
The detection patch according to claim 3, characterized in that the size of the first through hole on the first adhesive is larger than the size of the first electrode group;

The size of the second through hole on the first adhesive is larger than the size of the second electrode group;

The size of the third through hole on the second adhesive tape is greater than or equal to the size of the first through hole on the first adhesive tape;

The size of the fourth through hole on the second adhesive tape is greater than or equal to the size of the second through hole on the first adhesive tape.
The detection patch according to claim 2, characterized in that the detection patch further includes a release film and a waterproof film;

The release film is attached to a side surface of the first adhesive tape facing away from the flexible base;

The waterproof film is attached to a side surface of the second adhesive tape facing away from the flexible base, and is used to laminate and attach the first adhesive tape, the flexible electrode film and the second adhesive tape. on the body surface.
The detection patch according to claim 1, wherein the first electrode group includes a first working electrode, a first pair of electrodes and a first reference electrode, and the first pair of electrodes and the first reference electrode A ratio electrode is arranged around the first working electrode, and an activating enzyme is arranged on the surface of the first working electrode;

The second electrode group includes a second working electrode, a second counter electrode and a second reference electrode. The second counter electrode and the second reference electrode are arranged around the second working electrode. The second working electrode The surface is provided with the activating enzyme.
The detection patch according to claim 6, wherein the liquid injection hole is disposed in an area of the flexible base corresponding to the first through hole of the first adhesive patch, and is disposed in the first through hole of the first adhesive patch. The medial area or periphery of the electrode set;

The liquid injection hole is provided in an area of the flexible substrate corresponding to the second through hole of the first adhesive tape, and is provided in an inner area or outer periphery of the second electrode group.
A method for detecting physiological substances using the detection patch according to any one of claims 1 to 7, characterized in that it includes:

Step S1: Attach the detection patch to the body surface, so that the first through hole on the first adhesive tape, the first electrode group and the body surface of the corresponding area form a first storage liquid for storing electrolyte. Space, the second through hole on the first adhesive, the second electrode group and the body surface of the corresponding area form a second liquid storage space for storing electrolyte;

Step S2: Inject electrolyte into the first liquid storage space and the second liquid storage space through the liquid injection hole;

Step S3: Form a constant current path between the first electrode group and the second electrode group, so that subcutaneous physiological substances are extracted into the electrolysis in the first liquid storage space and the second liquid storage space. liquid;

Step S4: Disconnect the constant current path and form a constant potential path in the first electrode group or the second electrode group, so that the first electrode group or the second electrode group is opposite to the Subcutaneous physiological substances are detected to produce electrochemical signals;

Step S5: Determine the concentration of the subcutaneous physiological substance according to the electrochemical signal.
The method of claim 8, wherein before forming a constant current path between the first electrode group and the second electrode group, it further includes:

Under a preset voltage, baseline current detection is performed on the first electrode group and/or the second electrode group to stabilize the initial current in the electrolyte.
A detection system, characterized in that the detection system includes the detection patch and processing equipment according to any one of claims 1-7;

The detection patch is connected to the processing equipment;

The processing device is used to perform steps S3-S5 in the method as claimed in claim 8, or the method as claimed in claim 9.