Wearable sweat glucose continuous detection patch

Abstract

The invention belongs to the technical field of sweat analysis, and discloses a wearable sweat glucose continuous detection patch which comprises a first packaging layer, a bonding layer, a microfluid layer and a detection processing module are arranged on the first packaging layer; the bonding layer is used for bonding the first packaging layer to the skin; the microfluid layer is made of a hydrophilic material and comprises a sample introduction area, a detection area and an evaporation area which are connected in sequence; the detection processing module is in direct contact with the detection area and is used for detecting the glucose concentration of the detection area; when the first packaging layer is adhered to the skin, only the sample introduction area in the microfluid layer is in direct contact with the skin to absorb sweat, and only one end, far away from the detection area, of the evaporation area is exposed in the air; through mutual cooperation of capillary action and evaporation driving, one-way continuous flow of sweat from the sample introduction area and the detection area to the evaporation area is formed, and it is ensured that sweat samples in the detection area are continuously updated, so that the detection processing module can continuously detect the glucose concentration of sweat in the detection area in real time.

Description

Technical Field

[0001] This invention belongs to the field of sweat analysis technology, specifically relating to a wearable sweat glucose continuous detection patch. Background Technology

[0002] Because detection patches typically come into contact with the human body in a flexible and comfortable manner, they can bend freely with body movement and are suitable for long-term wear, thus they are widely used in the field of health monitoring. For example, Chinese patent CN219089303U discloses a wearable flexible patch for detecting glucose and pH values ​​in sweat, including an adhesive layer, a sweat-wicking layer, a detection layer, and a covering layer. Sweat is guided through the sweat-wicking layer to the colorimetric strip on the detection layer, and the glucose concentration and pH value are read by visually comparing with a color chart.

[0003] However, the detection chamber in the aforementioned patent is a closed or semi-closed reaction pool. After the sweat flows in and reacts with the test strip, it is retained. There is a lack of a microfluidic control mechanism to drive the continuous flow of sweat and refresh the sweat sample. This makes it impossible to perform a new round of detection on subsequent sweat. It can only reflect the cumulative average concentration over a certain period of time and cannot capture the dynamic change curve of glucose concentration over time. Therefore, the existing sweat glucose detection patch has the problem of not being able to achieve continuous sweat renewal and dynamic monitoring. Summary of the Invention

[0004] To address the shortcomings of existing technologies, the present invention aims to provide a wearable sweat glucose continuous detection patch, which solves the problem that existing sweat glucose detection patches cannot achieve continuous sweat updating and dynamic monitoring.

[0005] The objective of this invention can be achieved through the following technical solutions:

[0006] A wearable sweat glucose continuous detection patch includes a first encapsulation layer;

[0007] The first encapsulation layer includes an adhesive layer, a microfluidic layer, and a detection and processing module.

[0008] The adhesive layer is used to adhere the first encapsulation layer to the skin;

[0009] The microfluidic layer is made of a hydrophilic material and includes a sample injection zone, a detection zone, and an evaporation zone connected in sequence.

[0010] The detection and processing module is in direct contact with the detection area and is used to detect the glucose concentration in the detection area;

[0011] When the first encapsulation layer adheres to the skin:

[0012] In the microfluidic layer, only the sample injection area directly contacts the skin to absorb sweat, and only the end of the evaporation area furthest from the detection area is exposed to the air;

[0013] Sweat flows sequentially from the sample injection area through the detection area and the evaporation area via capillary action.

[0014] Furthermore, the area of ​​the sample injection zone is larger than the area of ​​the detection zone.

[0015] Furthermore, the detection and processing module includes a sensing electrode layer and a signal processing unit;

[0016] The sensing electrode layer is in contact with the detection area and is used to generate an electrochemical signal in response to the glucose concentration in sweat;

[0017] The signal processing unit is electrically connected to the sensing electrode layer and is used to receive the electrochemical signals from the sensing electrode layer.

[0018] Furthermore, the sensing electrode layer includes a second substrate and screen-printed electrodes printed on the second substrate;

[0019] Screen printing electrodes include a reference electrode, a counter electrode, and a working electrode;

[0020] The surface of the working electrode away from the second substrate is sequentially modified with a nanocomposite layer and an enzyme-based sensing layer, with the enzyme-based sensing layer facing the detection area and in direct contact with the detection area.

[0021] Furthermore, the nanocomposite layer is made of a Prussian blue-doped poly(3,4-ethylenedioxythiophene) nanocomposite material;

[0022] The enzyme-based sensing layer is made by doping glucose oxidase with glutaraldehyde as a cross-linking agent.

[0023] Furthermore, the sensing electrode layer also includes an insulating layer, which covers the side of the screen-printed electrode away from the second substrate. The insulating layer is fixed to the first encapsulation layer, and a detection hole with the same shape as the detection area is formed on the insulating layer. The working electrode, the nanocomposite layer and the enzyme-based sensing layer are all located in the detection hole.

[0024] Furthermore, the periphery of the detection well is modified with a hydrophobic layer.

[0025] Furthermore, both the sample injection area and the detection area are designed to be circular in shape.

[0026] Furthermore, the sample introduction area and the detection area are connected through the first flow channel;

[0027] The evaporation zone is formed by a second flow channel extending outward from the detection zone;

[0028] The widths of both the first and second flow channels are smaller than the radius of the detection area.

[0029] Furthermore, a second encapsulation layer is provided on the first encapsulation layer, and the detection and processing module is embedded in the second encapsulation layer;

[0030] The second encapsulation layer also contains an NFC antenna circuit module, and the signal processing unit contains a compatible NFC chip, which is electrically connected to the NFC antenna circuit module.

[0031] The beneficial effects of this invention are:

[0032] 1. This application utilizes the combined action of capillary action and evaporation to ensure that after the sweat is detected in the detection zone, as the body continuously secretes new sweat, the detected sweat sample flows continuously to the evaporation zone through capillary action. The sweat is then continuously evaporated through the part of the evaporation zone exposed to the air, thus forming a unidirectional continuous flow of sweat from the sample injection zone, detection zone to the evaporation zone. This flow process ensures that the sweat sample in the detection zone is constantly renewed, enabling the detection and processing module to achieve real-time and continuous detection of the glucose concentration in the sweat in the detection zone, and ultimately generate the corresponding glucose concentration data.

[0033] 2. This application adopts a method that does not directly detect sweat samples in the sample injection area. After entering the sample injection area, the sweat must pass through capillary action to reach the detection area for detection. This effectively avoids the influence of skin surface oils, dirt, and other contaminants on the detection accuracy when directly detecting sweat in the sample injection area, significantly improving the reliability and stability of the detection results and extending the service life of the detection processing module. At the same time, by avoiding direct detection between the electrochemical detection site and human skin, it effectively reduces irritation to the wearer's skin.

[0034] 3. This application modifies the working electrode sequentially with a nanocomposite layer composed of Prussian blue and poly(3,4-ethylenedioxythiophene) and an enzyme-based sensing layer formed by glutaraldehyde crosslinking glucose oxidase;

[0035] By using glutaraldehyde to crosslink glucose oxidase, the enzyme molecules are firmly fixed on the electrode surface to prevent loss during use, thereby improving the stability of the enzyme-based sensing layer and extending its service life; hydrogen peroxide is generated through the specific reaction of glucose oxidase with sweat glucose.

[0036] In conjunction with a nanocomposite layer made of Prussian blue and poly(3,4-ethylenedioxythiophene), the unique zeolite-type channel structure of Prussian blue provides a high density of active sites, significantly reducing the redox overpotential and thus improving negative pressure selectivity and signal-to-noise ratio. Simultaneously, the conductive polymer matrix of poly(3,4-ethylenedioxythiophene) not only stabilizes and disperses Prussian blue nanoparticles through electrostatic interactions, preventing their aggregation and deactivation, but also constructs efficient electron channels, significantly enhancing electron transfer capability and greatly improving electron transport efficiency. Through the synergy of Prussian blue and poly(3,4-ethylenedioxythiophene), the response current to trace amounts of hydrogen peroxide is significantly enhanced, thereby improving the detection accuracy of low concentrations of glucose in human sweat.

[0037] 4. By setting an insulating layer, the electrode leads are physically isolated from sweat, avoiding detection failure caused by short circuits and ensuring circuit reliability. Furthermore, by modifying the periphery of the detection hole with a hydrophobic layer, a reliable leakage-proof barrier is formed, strictly confining sweat within the detection area to prevent sweat from leaking into external circuits or causing measurement errors. Attached Figure Description

[0038] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, for those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0039] Figure 1 This is a schematic diagram of the overall structure of the present invention;

[0040] Figure 2 This is a schematic diagram of the microfluidic layer structure of the present invention;

[0041] Figure 3 This is a schematic diagram of the sensing electrode layer structure of the present invention;

[0042] Figure 4 This is a schematic diagram of the detection patch worn by volunteers in the experiment of this invention;

[0043] Figure 5 This is a comparison chart of the glucose concentration in sweat detected in the experiment of this invention and the glucose concentration detected by a commercial blood glucose meter;

[0044] Figure 6 This is a graph showing the glucose concentration in the sweat of volunteers after exercise in the experiment of this invention. Detailed Implementation

[0045] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0046] like Figures 1 to 3 As shown, a wearable sweat glucose continuous detection patch includes a first encapsulation layer 100 for adhesion to the skin, characterized in that the first encapsulation layer 100 is provided with a microfluidic layer 300 and a detection and processing module.

[0047] The microfluidic layer 300 is made of a hydrophilic material and includes a sample injection area 301, a detection area 302 and an evaporation area 303 connected in sequence.

[0048] The detection processing module is in direct contact with the detection area 302 and is used to detect the glucose concentration in the detection area 302.

[0049] When the first encapsulation layer 100 adheres to the skin:

[0050] In the microfluidic layer 300, only the sample injection area 301 directly contacts the skin to absorb sweat, and only the end of the evaporation area 303 away from the detection area 302 is exposed to the air;

[0051] Sweat flows sequentially from the sample injection area 301 through the detection area 302 and the evaporation area 303 via capillary action;

[0052] It should be noted that the first encapsulation layer 100 is provided with an adhesive layer 200, which is used to adhere the first encapsulation layer 100 to the skin.

[0053] Preferably, the microfluidic layer 300 is disposed between the first encapsulation layer 100 and the adhesive layer 200. The adhesive layer 200 has a first through hole 201 that is adapted to the shape of the sample injection area 301. The side of the sample injection area 301 away from the first encapsulation layer 100 passes through the first through hole 201 and adheres to the patient's skin.

[0054] Preferably, the detection processing module is fixedly installed on the side of the first encapsulation layer 100 away from the adhesive layer 200. The first encapsulation layer 100 has a second through hole 101 that matches the shape of the detection area 302. The detection processing module directly contacts the detection area 302 through the second through hole 101.

[0055] It should be noted that the first encapsulation layer 100 can be made of flexible materials such as polydimethylsiloxane (PDMS), silicone, or rubber; among them, the preferred material is polydimethylsiloxane, which has good biocompatibility compared to silicone or rubber, ensuring safety for long-term wear, while meeting the flexibility requirements to adapt to changes in human skin.

[0056] Preferably, the first encapsulation layer 100 has a placement groove for placing the microfluidic layer 300;

[0057] In use, the first encapsulation layer 100 is adhered to the patient's skin via the adhesive layer 200. Sweat secreted by the sweat glands of the human skin is absorbed by the sample injection area 301 and guided to the detection area 302 via capillary action. The detection processing module detects the glucose concentration in the sweat in the detection area 302. After the sweat is detected in the detection area 302, as the body continuously secretes new sweat, the detected sweat sample flows continuously to the evaporation area 303 via capillary action. The sweat evaporates through the portion of the evaporation area 303 exposed to the air, thus forming a unidirectional continuous flow of sweat from the sample injection area 301, the detection area 302, to the evaporation area 303. This flow process ensures that the sweat sample in the detection area 302 is constantly renewed, enabling the detection processing module to achieve real-time and continuous detection of the glucose concentration in the sweat in the detection area 302, and ultimately generate the corresponding glucose concentration data.

[0058] This application employs a method that does not directly detect sweat samples in the sample entry area 301. After entering the sample entry area 301, the sweat must pass through capillary action to reach the detection area 302 for detection. This effectively avoids the influence of skin surface oils, dirt, and other contaminants on the detection accuracy when directly detecting sweat in the sample entry area 301, significantly improving the reliability and stability of the detection results and extending the service life of the detection processing module. At the same time, by avoiding direct detection between the electrochemical detection site and human skin, it effectively reduces irritation to the wearer's skin.

[0059] The sample injection area 301 has a larger area than the detection area 302. The relatively larger sample injection area 301 can quickly collect more sweat, ensuring that the sweat continuously flows to the detection area 302, effectively shortening the detection waiting time and maintaining the continuity of the detection volume. The relatively smaller detection area 302 can effectively improve the sensitivity and accuracy of the detection, ensuring the stability and reliability of continuous detection of the patch.

[0060] The detection and processing module includes a sensing electrode layer 500 and a signal processing unit 400;

[0061] The sensing electrode layer 500 is in contact with the detection area 302 and is used to generate an electrochemical signal in response to the glucose concentration in sweat;

[0062] The signal processing unit 400 is electrically connected to the sensing electrode layer 500 and is used to receive the electrochemical signal from the sensing electrode layer 500 and convert it into glucose concentration data.

[0063] Preferably, the signal processing unit 400 is specifically integrated by an ultra-low power dedicated chip. Its initial signal acquisition and conditioning functions are performed by the analog front-end chip LMP91000, which operates with a power consumption of less than 36 microwatts and has a power supply voltage range of 2.70-5.25 volts. It is responsible for high-precision filtering and amplification of the microampere-level current signal output from the sensing electrode layer 500 and converting it into a voltage signal adapted to the microcontroller. The conditioned analog signal is processed by a signal conversion and calculation module based on the ultra-low power microcontroller MSP430G2553. This controller consumes only 506 microwatts in working mode, has a built-in analog-to-digital converter (ADC) to sample the input signal, and calculates the physiological glucose concentration value in real time through a preset linear fitting algorithm.

[0064] The above is only one specific embodiment of the signal processing unit 400. The multi-parameter detector circuit described in Chinese Patent Application No. CN202411571632.3, "A Wearable Sweat Real-time Detection Device and Detection Method Thereof", can also be used to replace the signal processing unit 400 in this application. Since the signal processing unit 400 is prior art, it will not be described in detail in this application. It should be noted that the signal processing unit 400 is disposed on the first substrate.

[0065] The sensing electrode layer 500 includes a second substrate 501 and screen-printed electrodes printed on the second substrate 501;

[0066] The screen printing electrode includes a reference electrode 502, a counter electrode 503, and a working electrode 504;

[0067] The surface of the working electrode 504 away from the second substrate 501 is sequentially modified with a nanocomposite layer 505 and an enzyme-based sensing layer 506, with the enzyme-based sensing layer 506 facing the detection area 302 and in direct contact with the detection area 302.

[0068] Preferably, the reference electrode 502, the counter electrode 503, and the working electrode 504 are fabricated on the second substrate 501 using a screen printing process; wherein, the reference electrode 502 is made of silver / silver chloride material, and the counter electrode 503 and the working electrode 504 are made of conductive carbon layer material.

[0069] The enzyme-based sensing layer 506 is used to perform a specific chemical reaction with glucose, identify glucose in the detection area 302 and convert it into a specific signal, and the nanocomposite layer 505 receives the specific signal and converts and amplifies it into a current signal.

[0070] Preferably, the signal processing unit 400 and the sensing electrode layer 500 are electrically connected via an FPC connector;

[0071] Preferably, both the first substrate and the second substrate 501 are made of PET substrate.

[0072] Nanocomposite layer 505 is made of a Prussian blue-doped poly(3,4-ethylenedioxythiophene) nanocomposite material.

[0073] The enzyme-based sensing layer 506 is made by doping glucose oxidase with glutaraldehyde as a cross-linking agent.

[0074] It should be noted that glutaraldehyde is a preferred method in this application. Glutaraldehyde can not only immobilize glucose oxidase on glucose electrodes through a mild reaction, but also improve sensing performance and extend electrode lifespan. In some embodiments, chitosan, Nafion solution, etc. can also be used as substitutes for glutaraldehyde.

[0075] The enzyme-based sensing layer 506, formed by cross-linking glucose oxidase with glutaraldehyde, achieves firm fixation of enzyme molecules on the electrode surface, preventing loss during use, improving the stability of the enzyme-based sensing layer 506 and extending its service life.

[0076] Glucose oxidase uses flavin adenine dinucleotide (FAD) as its active site and detects glucose through the reversible conversion between the oxidized (FAD) and reduced (FADH2) states of flavin adenine dinucleotide.

[0077] Oxidized FAD oxidizes glucose in detection area 302 to gluconic acid, and then reduces itself to FADH2. FADH2 is then reduced to FAD by oxygen in the environment. In this process, hydrogen peroxide (H2O2) exists in the environment as a byproduct of the FADH2 oxidation reaction. Hydrogen peroxide is the target molecule for electrochemical detection, and the generation rate of hydrogen peroxide is directly proportional to the glucose concentration in sweat.

[0078] Hydrogen peroxide diffuses into the nanocomposite layer 505 and undergoes an electrochemical oxidation reaction catalyzed by Prussian blue (PB). Prussian blue, as a highly efficient redox medium, has ion channels with a diameter of approximately 0.32 nm in its zeolite-like structure, providing a large number of active sites for hydrogen peroxide molecules. This allows hydrogen peroxide to diffuse rapidly within the crystal lattice, significantly reducing the redox overpotential and thus improving the reaction selectivity and signal-to-noise ratio. During the catalytic process, hydrogen peroxide accepts two electrons and two hydrogen ions, is reduced to water, and simultaneously generates an electrochemical current signal proportional to the glucose concentration.

[0079] Poly(3,4-ethylenedioxythiophene), also known as PEDOT, serves as a conductive polymer matrix. It not only stabilizes and disperses Prussian blue nanoparticles through electrostatic interactions, preventing their aggregation and deactivation, but also significantly enhances electron transfer capabilities, greatly improving electron transport efficiency. Through the synergy between Prussian blue and poly(3,4-ethylenedioxythiophene), the response current to trace amounts of hydrogen peroxide is significantly enhanced, thereby improving the detection accuracy of low concentrations of glucose in human sweat.

[0080] The sensing electrode layer 500 also includes an insulating layer 507, which covers the side of the screen-printed electrode away from the second substrate 501. The insulating layer 507 is fixed to the first encapsulation layer 100. A detection hole 5071 with the same shape as the detection area 302 is formed on the insulating layer 507. The working electrode 504, the nanocomposite layer 505 and the enzyme-based sensing layer 506 are all located in the detection hole 5071.

[0081] The area within the detection hole 5071 is the sensitive area of ​​the screen-printed electrode, and the area is the electrode lead. By setting the insulating layer 507, the electrode lead is physically isolated from sweat, avoiding detection failure caused by short circuit and ensuring the reliability of the circuit.

[0082] The periphery of the detection hole 5071 is modified with a hydrophobic layer; through the hydrophobic modification, the periphery of the detection hole 5071 forms a reliable anti-leakage barrier, which strictly confines sweat within the detection area 302 to prevent sweat from leaking into the external circuit or causing measurement errors.

[0083] Preferably, the hydrophobic agent that can be used for hydrophobic modification is MiPhobic-100.

[0084] Both the sample injection area 301 and the detection area 302 are circular in shape. When sweat diffuses in hydrophilic materials through capillary action, the circular structure has no sharp edges, which avoids the problem of liquid flow retention in the corner areas of other angular shapes.

[0085] Preferably, the sample injection area 301 is a circular area with a diameter of 12 mm, and the detection area 302 is a circular area with a diameter of 8 mm.

[0086] The sample introduction area 301 and the detection area 302 are connected by the first flow channel 304;

[0087] The evaporation zone 303 is formed by a second flow channel extending outward from the detection zone 302;

[0088] The widths of both the first flow channel 304 and the second flow channel are smaller than the radius of the detection area 302;

[0089] While ensuring the capillary flow of sweat, it is also necessary to limit the sweat flow rate to avoid signal fluctuations in the detection area 302 caused by excessively rapid sweat turnover, thus helping to maintain the stability of the detection signal. At the same time, it can prolong the residence time of sweat in the detection area 302, ensuring that glucose molecules can be fully detected by the detection and processing module, thereby improving detection sensitivity and accuracy.

[0090] Preferably, the first flow channel 304 and the second flow channel are configured as elongated strips with a width of 1.5 mm;

[0091] Preferably, the microfluidic layer 300 is made of qualitative filter paper, and the sample injection area 301, detection area 302 and evaporation area 303 are integrally formed. The microfluidic layer 300 is made of qualitative filter paper, which makes full use of its natural hydrophilicity and capillary effect, ensuring that sweat can spontaneously and stably flow from the sample injection area 301 to the detection area 302 and evaporation area 303. Moreover, the integrated design greatly reduces manufacturing costs, improves production efficiency and consistency, and facilitates the large-scale promotion and application of disposable patches.

[0092] A second encapsulation layer 600 is provided on the first encapsulation layer 100, and the detection and processing module is embedded in the second encapsulation layer 600.

[0093] The second encapsulation layer 600 also contains an NFC antenna circuit module 700, and the signal processing unit 400 contains a compatible NFC chip, which is electrically connected to the NFC antenna circuit module 700.

[0094] The NFC chip and NFC antenna circuit module 700 together form a passive wireless communication module. When a smartphone with NFC function is brought close to the patch, wireless power supply and signal transmission can be easily achieved.

[0095] NFC communication technology is existing technology and will not be described in detail in this application;

[0096] It should be noted that NFC communication is only one preferred method in this application; Bluetooth modules, 4G / 5G modules or WiFi modules can also be used for communication and data transmission in this application.

[0097] Preferably, the adhesive layer 200 can be made of medical-grade double-sided tape; for long-term repeated use, the adhesive layer 200 can be torn open to disassemble and replace the adhesive layer 200 and the microfluidic layer 300.

[0098] Preferably, the fabrication method of the nanocomposite layer 505 in this application is as follows: the screen-printed electrode is ultrasonically cleaned in deionized water for 5 minutes to remove residual contaminants adhering to the surface of the screen-printed electrode; then, 36 mg of Prussian blue and 24 μL of poly(3,4-ethylenedioxythiophene) are mixed, and 12 mL of ultrapure water is added. The mixture is stirred continuously at 1500 rpm for 4 hours using a magnetic stirrer to obtain a uniformly dispersed mixed electrolyte; the ultrasonically cleaned screen-printed electrode is immersed in the electrolyte, and a constant voltage of 1.2 volts is applied through an electrochemical workstation for continuous electrodeposition for 200 seconds to form the nanocomposite layer 505;

[0099] Subsequently, after drying at room temperature for 12 hours, the glutaraldehyde-glucose oxidase composite solution was modified onto the surface of the nanocomposite layer 505 using a drop-coating method. The specific steps are as follows: 5 mg of glucose oxidase powder was dissolved in 250 μL of 0.5% glutaraldehyde solution to prepare a composite solution with a concentration of 20 mg / mL. 8 mL of the composite solution was dropped onto the surface of the nanocomposite layer 505 using a microsyringe and dried at 4°C for 12 hours to form a stable enzyme-based sensing layer 506.

[0100] When using the patch, the skin surface of the area to be tested must first be cleaned with deionized water to remove interfering impurities such as dust and sebum adhering to the skin layer, ensuring the cleanliness of the skin at the area to be tested.

[0101] like Figure 4 As shown, in this application, the patch is attached to the volunteer's arm and tested through running exercises;

[0102] The curves showing the changes in blood glucose levels and sweat glucose concentration in volunteers are as follows: Figure 5 As shown in the figure; the experimental results showed that before consuming high-sugar foods, the volunteers' blood glucose curves remained relatively stable, with fluctuations not exceeding 0.3 mmol / L within one hour; after consuming high-sugar foods, the blood glucose curves showed a significant upward trend, with blood glucose levels increasing by 2.3 mmol / L within one hour post-meal. Subsequently, influenced by the body's metabolism and exercise expenditure, blood glucose levels gradually decreased over time. Notably, the volunteers' blood glucose fluctuation trend was synchronously reflected in the sweat glucose data detected by the sweat biosensor patch; under fasting conditions, the sweat glucose curve remained stable; after consuming high-sugar foods, the sweat glucose curve significantly increased by 48 μmol / L within one hour, subsequently gradually decreasing over time.

[0103] To further verify the continuous glucose concentration monitoring capability of this invention, the real-time distribution of sweat glucose measurements and blood glucose data before and after the test cycle were recorded for two volunteers during a 20-minute continuous testing period (e.g., Figure 6(As shown in the figure); the results showed that the blood glucose levels of volunteers 1 and 2 decreased significantly due to continuous aerobic exercise, decreasing by 1.3 mmol / L and 1.1 mmol / L, respectively; at the same time, the sweat glucose concentration curves of the two volunteers also showed a trend consistent with the blood glucose level during exercise; the above experimental results indicate that the wearable sweat glucose detection patch proposed in this invention has excellent performance in tracking and predicting blood glucose fluctuations in the human body.

[0104] In the description of this specification, references to terms such as "an embodiment," "example," "specific example," etc., indicate that a specific feature, structure, material, or characteristic described in connection with that embodiment or example is included in at least one embodiment or example of the invention. In this specification, illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples.

[0105] The foregoing has shown and described the basic principles, main features, and advantages of the present invention. Those skilled in the art should understand that the present invention is not limited to the above embodiments. The embodiments and descriptions in the specification are merely illustrative of the principles of the invention. Various changes and modifications can be made to the present invention without departing from its spirit and scope, and all such changes and modifications fall within the scope of the claimed invention.

Claims

1. A wearable sweat glucose continuous detection patch, comprising a first encapsulation layer (100) for adhesion to the skin, characterized in that, The first encapsulation layer (100) is provided with a microfluidic layer (300) and a detection and processing module; The microfluidic layer (300) is made of a hydrophilic material and includes a sample injection area (301), a detection area (302) and an evaporation area (303) connected in sequence. The detection processing module is in direct contact with the detection area (302) and is used to detect the glucose concentration in the detection area (302); When the first encapsulation layer (100) adheres to the skin: In the microfluidic layer (300), only the sample injection area (301) directly contacts the skin to absorb sweat, and only the end of the evaporation area (303) away from the detection area (302) is exposed to the air; Sweat flows sequentially from the sample injection area (301) through the detection area (302) and the evaporation area (303) via capillary action.

2. The wearable sweat glucose continuous detection patch according to claim 1, characterized in that, The area of ​​the sample injection area (301) is larger than the area of ​​the detection area (302).

3. The wearable sweat glucose continuous detection patch according to claim 2, characterized in that, The detection and processing module includes a sensing electrode layer (500) and a signal processing unit (400); The sensing electrode layer (500) is in contact with the detection area (302) to generate an electrochemical signal in response to the glucose concentration in sweat; The signal processing unit (400) is electrically connected to the sensing electrode layer (500) and is used to receive the electrochemical signal from the sensing electrode layer (500).

4. The wearable sweat glucose continuous detection patch according to claim 3, characterized in that, The sensing electrode layer (500) includes a second substrate (501) and screen-printed electrodes printed on the second substrate (501); The screen printing electrode includes a reference electrode (502), a counter electrode (503), and a working electrode (504); The working electrode (504) is sequentially modified with a nanocomposite layer (505) and an enzyme-based sensing layer (506) on the side away from the second substrate (501). The enzyme-based sensing layer (506) faces the detection area (302) and is in direct contact with the detection area (302).

5. The wearable sweat glucose continuous detection patch according to claim 4, characterized in that, The nanocomposite layer (505) is made of a Prussian blue-doped poly(3,4-ethylenedioxythiophene) nanocomposite material; The enzyme-based sensing layer (506) is made by doping glucose oxidase with glutaraldehyde as a cross-linking agent.

6. The wearable sweat glucose continuous detection patch according to claim 5, characterized in that, The sensing electrode layer (500) also includes an insulating layer (507), which covers the side of the screen-printed electrode away from the second substrate (501). The insulating layer (507) is fixed on the first encapsulation layer (100). A detection hole (5071) with the same shape as the detection area (302) is opened on the insulating layer (507). The working electrode (504), the nanocomposite layer (505) and the enzyme-based sensing layer (506) are all located in the detection hole (5071).

7. The wearable sweat glucose continuous detection patch according to claim 6, characterized in that, The periphery of the detection well (5071) is modified with a hydrophobic layer.

8. The wearable sweat glucose continuous detection patch according to claim 1, characterized in that, Both the sample injection area (301) and the detection area (302) are circular in shape.

9. The wearable sweat glucose continuous detection patch according to claim 8, characterized in that, The sample injection area (301) and the detection area (302) are connected by a first flow channel (304); The evaporation zone (303) is formed by a second flow channel extending outward from the detection zone (302); The widths of both the first flow channel (304) and the second flow channel are smaller than the radius of the detection area (302).

10. The wearable sweat glucose continuous detection patch according to claim 1, characterized in that, A second encapsulation layer (600) is connected to the first encapsulation layer (100), and the detection and processing module is embedded in the second encapsulation layer (600). The second encapsulation layer (600) also contains an NFC antenna circuit module (700), and the signal processing unit (400) contains a compatible NFC chip, which is electrically connected to the NFC antenna circuit module (700).

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