A wearable continuous dynamic uric acid intelligent monitoring device

Abstract

The application relates to the technical field of intelligent devices, and discloses a wearable continuous dynamic uric acid intelligent monitoring device, which comprises a device body and is worn on a human body; a skin adhesion layer, a bionic micro-fluidic gel layer and an integrated ion electrophoresis electrode substrate are sequentially arranged on the device body from outside to inside; the skin adhesion layer is in contact with the human skin; the bionic micro-fluidic gel layer is used for collecting sweat on the human skin and guiding the sweat into a detection area on the bionic micro-fluidic gel layer; an electrochemical detection unit is arranged on the integrated ion electrophoresis electrode substrate; the electrochemical detection unit is used for detecting the sweat in the detection area; an analysis feedback module is arranged on the device body; and data detected by the electrochemical detection unit is fed back to a wearer after being analyzed by the analysis feedback module. The application can realize real-time dynamic monitoring of uric acid levels and meet the comfortable, convenient and accurate uric acid monitoring requirements of gout patients.

Description

Technical Field

[0001] This invention relates to the field of intelligent device technology, and in particular to a wearable continuous dynamic intelligent uric acid monitoring device. Background Technology

[0002] Uric acid is an important metabolic product in the human body, mainly regulated by purine metabolism and uric acid excretion. Imbalanced uric acid levels can lead to hyperuricemia and various serious complications, including gout, cardiovascular disease, and kidney disease. However, current methods for detecting hyperuricemia are all single-point invasive tests, which cannot achieve continuous dynamic monitoring of blood uric acid levels. They cannot comprehensively and accurately reflect the dynamic changes in blood uric acid levels throughout the day, and frequent blood tests severely impact patients' quality of life. If monitoring methods are not improved in a timely manner, treatment adherence will be seriously affected.

[0003] In recent years, the rapid development of wearable sensors for comfortable and non-invasive disease diagnosis has attracted increasing attention. Sweat contains a large number of biochemical metabolites, including glucose, urea, uric acid, and metal ions, which can reflect a patient's metabolism and health status, making it an ideal choice for non-invasive health monitoring and disease diagnosis. Currently, most wearable devices provide intermittent monitoring, unable to continuously and dynamically monitor uric acid levels, thus failing to meet the needs of continuous monitoring in daily life. Furthermore, existing wearable smart monitoring devices often only acquire uric acid values ​​without further evaluation and statistical analysis, failing to fully realize their medical potential and truly achieve disease diagnosis and early warning. Additionally, these wearable devices primarily rely on sensor detection and data analysis, with limited user interaction and feedback, failing to provide users with intelligent health predictions.

[0004] Therefore, there is an urgent need for a wearable, continuous, dynamic, intelligent uric acid monitoring device to solve the above problems. Summary of the Invention

[0005] The purpose of this invention is to provide a wearable, continuous, dynamic, intelligent uric acid monitoring device to solve the problems existing in the prior art.

[0006] To achieve the above objectives, the present invention provides the following solution: The present invention provides a wearable continuous dynamic uric acid intelligent monitoring device, comprising: The device itself is worn on the human body; The device body is provided with a skin adhesive layer, a biomimetic microfluidic gel layer and an integrated ion electroosmotic electrode substrate arranged sequentially from the outside to the inside. The skin adhesive layer is in contact with human skin. The biomimetic microfluidic gel layer is used to collect sweat from human skin and guide the sweat to the detection area on the biomimetic microfluidic gel layer. An electrochemical detection unit is provided on the integrated ion electroosmotic electrode substrate, which is used to detect the sweat in the detection area. An analysis and feedback module is installed on the device body. The data detected by the electrochemical detection unit is analyzed by the analysis and feedback module, and the final result is fed back to the wearer.

[0007] Preferably, the skin adhesive layer includes a skin adhesive plate that is attached to the wearer's skin. The skin adhesive plate has a sweat inflow area for transferring sweat, and the sweat inflow area is used to collect sweat from the wearer's body.

[0008] Preferably, the biomimetic microfluidic gel layer includes an electrochemical monitoring region, the top of which is connected to a plurality of sweat inflow channels, through which sweat enters the electrochemical monitoring region, and the bottom of which is connected to a plurality of sweat outflow channels, through which waste sweat flows into the sweat evaporation channels and is discharged.

[0009] Preferably, the integrated iontophoresis electrode substrate includes an electrode plate, on which a temperature monitoring working electrode, an iontophoresis electrode, a reference electrode, a counter electrode, and multiple working electrodes are connected by wires. The multiple working electrodes are used to detect glucose, uric acid, and pH value in sweat, respectively.

[0010] Preferably, it also includes an iontophoresis hydrogel layer disposed between the sweat inflow channel and the electrochemical monitoring area.

[0011] Preferably, the device body includes a dial, with watch straps connected to both sides of the dial, and a detection groove is provided on the dial.

[0012] Preferably, the analysis feedback module includes a signal processing module and a transmission module. The sensor acquisition signal terminal of the signal processing module is connected to the electrode plate. The signal processing module processes the acquired glucose, uric acid, pH value and temperature signals, and sends the processed result signal to the transmission module.

[0013] Preferably, the signal processing module includes a sensor signal acquisition terminal, an amplifier module, an analog-to-digital conversion module, a communication module, and a processor module.

[0014] Compared with the prior art, the present invention has the following advantages and technical effects: 1. This invention provides a wearable, continuous, dynamic, intelligent uric acid monitoring device. The main body of the device is worn on the human body. The skin-adhesive layer adheres tightly to the skin to collect sweat and connects to the upper microfluidic gel layer. The microfluidic gel layer is modeled after the structure of *Sclerotium dentatum*, and is equipped with wedge-shaped channels radiating outwards from the electrochemical monitoring area. The wedge-shaped channels consist of a large wedge channel and smaller wedge channels surrounding the large wedge channel, enabling effective transfer of sweat and continuous collection and renewal of sweat during both resting and active states throughout the day. The collected sweat enters the upper microfluidic gel layer. Based on electrochemical detection technology, the uric acid concentration is detected by the electrochemical detection unit using the redox reaction between the electrode and the chemical components in the sweat. By measuring the electrical signals such as current, potential, or conductivity generated by the reaction, quantitative analysis of multiple components in the sweat is achieved. Through the set analysis feedback module, data transmission and voice broadcast are realized.

[0015] 2. This application integrates a microfluidic gel layer with an iontophoresis electrode substrate to generate sweat in a resting state, allowing for prolonged wear on the skin and continuous monitoring of uric acid levels. This is highly valuable for tracking health status and managing diseases. It also enables sweat to be effectively guided to the detection area and discharged after analysis, preventing device overload.

[0016] 3. By enabling in-depth analysis of the collected data, more accurate health monitoring and disease diagnosis can be provided. Real-time feedback is available, allowing for timely notification of users when abnormal physiological parameters are detected, providing opportunities for early intervention. This application can dynamically monitor uric acid levels in real time, meeting the needs of gout patients for comfortable, convenient, and accurate uric acid monitoring, improving patient treatment adherence, promoting active uric acid level control, and providing reasonable health management advice. Attached Figure Description

[0017] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the embodiments will be briefly described below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort. Figure 1 This is a schematic diagram of the main structure of the present invention; Figure 2 This is a schematic diagram of the integrated ion electroosmosis electrode substrate structure of the present invention; Figure 3 This is a schematic diagram of the sweat inflow channel structure of the present invention; Figure 4 This is a flowchart of the data analysis process for this invention; Figure 5 This is a schematic diagram of the main structure of the device of the present invention; Figure 6 This is a flowchart illustrating the signal transmission process of the present invention. The components are as follows: 1. Skin; 2. Skin adhesive plate; 3. Sweat inflow area; 4. Ion-electroosmotic electrode outflow pores; 5. Ion-electroosmotic hydrogel layer; 6. Sweat evaporation channel; 7. Electrochemical monitoring area; 8. Sweat inflow channel; 9. Encapsulation layer; 10. Electrode plate; 11. Wire; 12. Counter electrode; 13. Working electrode; 14. Temperature monitoring working electrode; 15. Reference electrode; 16. Ion-electroosmotic electrode; 17. Sweat outflow channel; 18. Dial; 19. Detection tank; 20. Watch strap. Detailed Implementation

[0018] 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.

[0019] To make the above-mentioned objects, features and advantages of the present invention more apparent and understandable, the present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments.

[0020] Reference Figures 1-6 This invention provides a wearable, continuous, dynamic, intelligent uric acid monitoring device, comprising: The device itself is worn on the human body; The device body is provided with a skin adhesive layer, a biomimetic microfluidic gel layer and an integrated ion electroosmotic electrode substrate, arranged from the outside to the inside. The skin adhesive layer is in contact with human skin. The biomimetic microfluidic gel layer is used to collect sweat from human skin and guide the sweat to the detection area on the biomimetic microfluidic gel layer. An electrochemical detection unit is provided on the integrated ion electroosmotic electrode substrate, which is used to detect the sweat in the detection area. The analysis and feedback module is located on the device itself. The data detected by the electrochemical detection unit is analyzed by the analysis and feedback module, and the final result is fed back to the wearer.

[0021] In one embodiment of this application, the main body of the device is worn on the human body. The skin adhesive layer adheres tightly to the skin to collect sweat and connects with the upper microfluidic gel layer to achieve effective sweat transfer. This enables the collection and renewal of sweat during both resting and active states throughout the day. The collected sweat enters the upper microfluidic gel layer. Based on electrochemical detection technology, the concentration of uric acid is detected by the electrochemical detection unit using the redox reaction between the electrode and the chemical components in the sweat. By measuring the electrical signals such as current, potential, or conductivity generated by the reaction, quantitative analysis of multiple components in the sweat is achieved. The set analysis feedback module enables data transmission and voice broadcast. Specifically, an encapsulation layer 9 is also set to encapsulate the top layer.

[0022] As an optional implementation, the skin adhesive layer includes a skin adhesive plate 2, which is attached to the wearer's skin 1. The skin adhesive plate 2 has a sweat inflow area 3 for transferring sweat, which is used to collect sweat from the wearer's body.

[0023] In one embodiment of this application, a rectangular adhesive layer is formed on the skin surface using a highly adhesive and hypoallergenic medical tape. The medical tape possesses excellent waterproof properties and adheres well to the skin. Channels designed on the tape for sweat transfer are incorporated, enabling effective sweat removal while maintaining the integrity and waterproofness of the adhesive layer. These channels connect to a microfluidic gel layer, serving as fluid channels from the skin to the microfluidic gel layer and establishing a sealed, waterproof, and stable adhesive interface between the two.

[0024] As an optional implementation, the biomimetic microfluidic gel layer includes an electrochemical monitoring region 7. The top of the electrochemical monitoring region 7 is connected to several sweat inflow channels 8, through which sweat enters the electrochemical monitoring region 7. The bottom of the electrochemical monitoring region 7 is connected to several sweat evaporation channels 6 through several sweat outflow channels 17, through which waste sweat flows into the sweat evaporation channels 6 and evaporates and is discharged.

[0025] In one embodiment of this application, a biomimetic microfluidic gel layer, referencing the water-collecting structure of *Rhizopus dentata*, is used to collect trace amounts of sweat from the human body under different sweating rates, such as at rest, during work, and during exercise, overcoming the limitations of traditional devices that rely on active movement. The sweat flows spontaneously through capillary action and Laplace force, adapting to different sweating rates. An electrochemical monitoring zone is located at the center of the biomimetic microfluidic gel layer, with several sweat inlets connected to its top. Referencing the awn-like structure of *Rhizopus dentata*, wedge-shaped sweat inflow channels 8 radiating outwards from the electrochemical monitoring zone 7 are arranged. Four to eight large wedge-shaped channels are evenly distributed radially around the electrochemical monitoring zone 7, pointing radially towards the detection area. Within each large wedge-shaped channel, several smaller wedge-shaped channels are further arranged, forming a multi-level water-collecting structure with nested smaller triangles within a large triangle, simulating the water-collecting unit on the awn-like surface of *Rhizopus dentata* leaves. The large wedge channel has a length of 6.0–8.0 mm, an opening width (away from the detection area) of 600–800 μm, and a tip width (closest to the detection area) of 80–120 μm. The small wedge channel has a length of 0.8–1.5 mm, an opening width of 120–200 μm, and a tip width of 20–50 μm. The electrochemical monitoring area is located at the geometric center of the biomimetic microfluidic gel layer, accommodating the electrochemical sensing electrode and enabling stable detection. The detection area is semi-circular, with a diameter of 3.0–4.0 mm. Six sweat outflow channels 17 are located downstream of the electrochemical monitoring area to promptly drain sweat after detection. The width of each sweat outflow channel is 300–500 μm. A sweat evaporation channel 6 is located at the end of each sweat outflow channel to regulate gas-liquid exchange and prevent abnormal negative pressure in the detection area. The evaporation channel adopts a parallel fine groove structure, with a channel width of 300–600 μm and a spacing of 150–200 μm between adjacent evaporation channels.

[0026] The above patterns are engraved using laser engraving. First, a substrate with good mechanical strength and processing stability is selected as the engraving substrate. The substrate is preferably a polyurethane (PU) sheet or a polymethyl methacrylate (PMMA) sheet, with a thickness of 0.5–1.0 mm. Before engraving, the substrate surface is cleaned to remove oil and dust to ensure the accuracy of microstructure processing. Then, based on the design drawing of the biomimetic toothed erythrosporum water collection structure, a microfluidic structure path file is generated using computer-aided design software (3Dmax), and this path file is imported into the laser processing equipment. The substrate is etched layer by layer using an ultraviolet laser or CO2 laser engraving equipment. During processing, the width and depth of the channels are controlled by adjusting the laser power, scanning speed, and number of repeated scans to ensure that the dimensions of the formed wedge-shaped channels, microchannels, and evaporation channels meet the requirements. After engraving, the processed substrate is ultrasonically cleaned to remove residual debris. The engraved substrate is used as a mold. Liquid polydimethylsiloxane (PDMS) or hydrogel precursor liquid is poured into the mold. After curing and demolding, a microfluidic gel layer with a biomimetic toothed erythrorhizon water-collecting structure is obtained. The inside of the channel is subjected to plasma treatment to improve the hydrophilicity of the inner surface of the channel, thereby enhancing the capillary transport capacity of sweat in the biomimetic microfluidic gel layer.

[0027] As an optional implementation, the integrated iontophoresis electrode substrate includes an electrode plate 10. The electrode plate 10 is connected to a temperature monitoring working electrode 14, an iontophoresis electrode 16, a reference electrode 15, a counter electrode 12, and multiple working electrodes 13 via wires 11. The multiple working electrodes 13 are used to detect glucose, uric acid, and pH value in sweat, respectively.

[0028] As an optional implementation, an iontophoretic hydrogel layer 5 is also included, disposed between the sweat inflow channel 8 and the electrochemical monitoring area 7.

[0029] As an optional implementation, the ion-electroosmotic hydrogel layer 5 is a polyvinyl alcohol, polyacrylamide, and polyvinyl alcohol-polyacrylamide dual-network hydrogel, and the water content of the hydrogel layer is 70%–95%.

[0030] In one embodiment of this application, an iontophoresis hydrogel layer 5, combined with an iontophoresis electrode 16, is disposed between the sweat inflow channel and the electrochemical detection zone to actively drive the directional migration of sweat in the microfluidic system under low sweating or resting conditions. The iontophoresis hydrogel layer 5, the iontophoresis cathode, and the iontophoresis anode generate electroosmotic flow under an applied low voltage, actively driving the sweat migration in the sweat inflow channel. The iontophoresis hydrogel layer 5 is a highly hydrated polymer network with continuous ion channels, and its material is selected from polyvinyl alcohol (PVA), polyacrylamide (PAAm), and polyvinyl alcohol-polyacrylamide dual-network hydrogels. The water content of the hydrogel layer is preferably 70%–95% to ensure good ion migration capacity and electroosmotic flow efficiency. During the hydrogel formation process, an electrolyte (NaCl) is introduced to increase the ion concentration inside the gel, thereby enhancing the electroosmotic effect. The iontophoresis cathode is disposed near the sweat outflow channel, preferably downstream of the electrochemical detection zone. The cathode comprises a conductive substrate, an electrode interface where the cathode conductive layer directly contacts the hydrogel, and under an applied voltage, cations (such as Na⁺) within the hydrogel migrate towards the cathode, generating directional electroosmotic flow (EOF) under the influence of the electric field and the electrical double layer. Because the hydrogel network surface is negatively charged, water molecules migrate towards the cathode under the dragging effect of cations, thereby driving sweat to flow into the sweat inflow channel and enter the detection area. The ion-electroosmotic anode is positioned near the sweat inlet, preferably below the skin adhesion layer or near the sweat inflow channel. The anode comprises a conductive substrate, an electrode interface where the anode conductive layer contacts the hydrogel, and so on. To avoid interference from electrolytic reactions at the anode (such as pH changes or gas generation) on sweat detection, a buffer hydrogel region or an isolation microchannel structure is provided between the anode and the main detection channel. The buffer zone absorbs ion changes generated by the anode, thereby ensuring the stability of the sweat composition in the detection area. This device integrates a programmable iontophoresis electrode substrate and sets an upper limit for the iontophoresis current as a safety mechanism. This effectively avoids the corrosion of electrodes and the severe skin irritation, overheating, and device burns caused by traditional iontophoresis therapy techniques. It enables the collection and renewal of sweat during both resting and active periods throughout the day. Through functional modifications, it achieves excellent and stable conductivity, thereby enabling continuous monitoring of uric acid concentration and generating a stable electrochemical signal.

[0031] In one embodiment of this application, the working electrode 13 is used for detecting glucose, uric acid, and pH value in sweat, and the temperature monitoring working electrode 14 is used for detecting temperature parameters. The overall structure is a four-layer structure, consisting of a conductive layer, a reference electrode layer, a counter electrode and working electrode layer, and an insulating layer from bottom to top. The reference electrode layer covers the conductive layer, the counter electrode and working electrode layer covers the reference electrode, and the insulating layer covers the conductive layer, the reference electrode layer, and the counter electrode and working electrode layer.

[0032] The lead wire 11 is fixed on the lead wire layer, the reference electrode is fixed on the reference electrode layer, and the counter electrode and working electrode are fixed on the counter electrode and working electrode layers. The electrodes are connected to external electrical signals through the lead wire 11 and are used to detect glucose, uric acid, pH value and temperature.

[0033] In one embodiment of the present invention, the reference electrode is a petal-shaped electrode, the counter electrode is a petal-shaped electrode point, and all working electrodes are petal-shaped electrode points. Each working electrode comprises three electrode units and nine wires, each with a terminal at its end. The reference electrode is connected to one terminal via one wire, which transmits a reference potential signal. The three working electrodes are connected to three other terminals via three wires, which transmit the signal of the three working electrodes. The four working electrode units are fabricated using the following process: (1) Glucose detection electrode unit Weigh carbon nanotube (CNT) powder and add it to deionized water to prepare a CNT dispersion with a mass concentration of 2 mg / mL. Add an appropriate amount of surfactant (SDS or Nafion) to the dispersion and treat it under ultrasonic conditions for 30–60 min to obtain a uniform and stable CNT dispersion. (The text then abruptly shifts to a seemingly unrelated topic: Ti3C2T...) x MXene nanosheets were added to deionized water to prepare an MXene nanosheet dispersion with a mass concentration of 4 mg / mL; ultrasonic exfoliation was performed for 30 min under an inert atmosphere or in the dark to obtain a stable MXene colloidal solution.

[0034] The CNT dispersion and MXene nanosheet dispersion were mixed at a volume ratio of 1:3. After thorough mixing, the mixture was sonicated for 5–10 min. 2 μL of the mixed solution was then dropped onto the surface of the working electrode using a pipette and allowed to dry naturally at room temperature to form a uniformly covered MXene-CNT composite conductive layer.

[0035] Glucose oxidase (GOx) was dissolved in acetic acid buffer to prepare an enzyme solution with a concentration of 10 mg / mL. 2 μL of the glucose oxidase solution was added dropwise to the surface of the working electrode with the MXene-CNT composite conductive layer already formed, and incubated at 4°C or room temperature for 30–60 min to allow for complete enzyme adsorption. 0.5 μL of a 5% glutaraldehyde solution was then added dropwise to the enzyme-modified working electrode surface to initiate a cross-linking reaction for 10–20 min. After cross-linking, the electrode surface was gently rinsed with deionized water to remove unfixed enzyme molecules and residual cross-linking agent, and then allowed to air dry at room temperature. The glucose detection electrode unit prepared by the above steps exhibits good conductivity, biocompatibility, and enzyme immobilization stability, making it suitable for the electrochemical detection of glucose in sweat.

[0036] (2) Uric acid detection electrode unit The same MXene-CNT composite conductive layer as the glucose detection electrode was used for construction. Uricase was dissolved in PBS or acetic acid buffer to prepare an enzyme solution with a concentration of 5–10 mg / mL. 2 μL of uricase solution was dropped onto the surface of the MXene-CNT composite layer and incubated at 4°C or room temperature for 30–60 min to allow the enzyme molecules to be fully adsorbed.

[0037] 0.5 μL of a 2.5%–5% glutaraldehyde solution was added to the surface of the enzyme-modified working electrode, and a cross-linking reaction was carried out for 10–20 min. After the reaction was completed, the electrode was gently rinsed with deionized water to remove unfixed enzyme molecules and residual cross-linking agents, and then allowed to air dry at room temperature. The uric acid detection electrode unit prepared by the above steps has high catalytic activity and stability, and is suitable for the electrochemical detection of uric acid in sweat.

[0038] (3) pH detection electrode unit The screen-printed carbon working electrode was rinsed sequentially with deionized water and ethanol to remove surface impurities and then dried at room temperature. Aniline monomer was added to an acidic electrolyte (0.1 mol / L HCl or H₂SO₄ solution) to prepare an electropolymerization solution with an aniline concentration of 0.1 mol / L; the solution was then deoxygenated before use.

[0039] The working electrode, reference electrode, and counter electrode were placed in an electropolymerization solution, and electrochemical polymerization was performed using cyclic voltammetry (CV). The scan potential range was set from -0.2V to +0.8V (vsAg / AgCl), the scan rate was 20–50 mV / s, and the number of cycles was 5–15. A polyaniline (PANI) sensitive film was deposited on the surface of the working electrode. After polymerization, the electrode was removed and thoroughly rinsed with deionized water to remove unreacted monomers. The electrode was then placed in a neutral buffer solution and allowed to stand for 1–2 hours to improve the electrochemical stability of the polyaniline film. The prepared polyaniline-modified electrode exhibited a good linear response of open-circuit potential or electrochemical signal to changes in solution pH, making it suitable for real-time detection of sweat pH.

[0040] (4) Temperature detection electrode unit A temperature-sensitive conductive material layer is deposited on the surface of the working electrode using screen printing. The temperature-sensitive material can be a metal thin film, a carbon-based conductive layer, or a conductive polymer material, and its resistance changes reversibly with temperature. After printing, it is cured at 60°C for 20–30 minutes to ensure a firm bond between the temperature-sensitive layer and the electrode substrate. The prepared temperature electrode is calibrated under different temperature conditions to establish the correlation between temperature and resistance or electrochemical signal for subsequent data correction. The temperature detection electrode unit prepared through the above steps can achieve real-time monitoring of the local ambient temperature and can be used for temperature compensation of electrochemical signals of glucose, uric acid, and pH.

[0041] As an optional implementation, the device body includes a dial 18, with straps 20 connected to both sides of the dial 18, and a detection groove 19 provided on the dial 18.

[0042] In one embodiment of this application, the device body includes a dial 18, with straps 20 connected to both sides of the dial 18. A detection groove 19 is provided on the dial 18, and a skin adhesive layer, a microfluidic gel layer, and an integrated iontophoresis electrode substrate are sequentially disposed within the detection groove 19. The dial 18 is worn on the body via the straps 20. The top encapsulation layer 9 is made of polyurethane material with higher chemical corrosion resistance, effectively resisting corrosion from acids, alkalis, greases, etc., protecting the device from external interference such as moisture and dust, making it particularly suitable for long-term wear environments and extending the device's lifespan.

[0043] As an optional implementation, the analysis feedback module includes a signal processing module and a transmission module. The sensor acquisition signal terminal of the signal processing module is connected to the electrode plate 10. The signal processing module processes the acquired glucose, uric acid, pH value and temperature signals, and sends the processed result signal to the transmission module.

[0044] As an optional implementation, the signal processing module includes a sensor signal acquisition terminal, an amplifier module, an analog-to-digital converter module, a communication module, and a processor module.

[0045] In one embodiment of this application, the signal generated by the electrochemical sensing unit ultimately needs to be transduced, regulated, and processed by electronic components to filter out noise and calibrate and compensate the signal. The signal processing and transmission module includes a front-end analog circuit, a conversion circuit, and a microcontroller circuit. The front-end analog circuit is connected to the microcontroller circuit through the aforementioned conversion circuit. The power supply component is electrically connected to the front-end analog circuit, the conversion circuit, and the microcontroller circuit. The front-end analog circuit is connected to the electrode connections in the electrochemical sensing unit.

[0046] For sweat data collection, processing, and analysis, a wireless transmission protocol is needed to transmit and visualize the collected information to a terminal device for easy observation. Sweat volume estimation is based on the measurement of the diffusion region. This invention accurately measures the size of the sweat diffusion region within the channel, including key parameters such as length and width. Subsequently, combining the channel width, the size of the diffusion region, and the physical properties of sweat, such as density and viscosity, a reasonable mathematical model is used for volume estimation. For the quantitative measurement of metabolites and electrolytes in sweat, a constant potential generated by a DA conversion module according to SPI configuration is applied between the working electrode 13 and the reference electrode 15 via an electrolytic cell as an excitation signal. When the redox potential of the electroactive components in the system is close to this applied potential, a redox reaction occurs on the surface of the working electrode 13, thereby generating a response current between the working electrode and the counter electrode that is proportional to the concentration of the target analyte. By accurately measuring the magnitude of this current, quantitative analysis of metabolites in sweat can be performed.

[0047] To reduce data dimensionality and extract core information, this invention introduces Principal Component Analysis (PCA) to perform dimensionality reduction on the dataset. PCA transforms potentially correlated variables into a linearly independent set of variables, i.e., principal components, through orthogonal transformation. These principal components can significantly improve the efficiency and effectiveness of subsequent Artificial Neural Network (ANN) inputs with minimal information loss.

[0048] At the data partitioning level, in order to avoid the potential overfitting risk of the ANN prediction model, this invention adopts the cross-validation method, which scientifically divides the samples into a training set (70%), a validation set (15%), and a test set (15%), to ensure the robustness and generalization performance of the model on different datasets.

[0049] This invention constructs a backpropagation-artificial neural network model (BP-ANN) for classifying gout patients and healthy individuals. The architecture comprises three main layers: an input layer, a hidden layer, and an output layer. The input layer receives preprocessed sweat data; the hidden layer uses nonlinear transformations to deeply mine data features; and the output layer outputs the final classification result, containing two neurons corresponding to the two categories: gout patients and healthy individuals.

[0050] This invention incorporates the VTX326 chip to further enhance the functionality of the wearable device. The VTX326 chip enables the wearable device to connect with various smart devices, such as smartphones or tablets, via Bluetooth, facilitating data transmission and voice announcements. When uric acid levels rise, the device immediately alerts the user via voice announcement, achieving real-time monitoring and reporting. Furthermore, with the built-in VTX326 chip, the wearable device can monitor the user's heart rate, steps, sleep quality, and other indicators in real time. Upon detecting abnormalities, it alerts the user via voice announcement, such as, "Your heart rate is slightly fast; please try taking deep breaths to relax." In addition, based on the user's daily activities and uric acid and blood sugar levels, it can provide personalized voice suggestions, encouraging the user to engage in appropriate exercise and dietary adjustments to maintain a healthy physiological state.

[0051] The BLE technology employed in this invention enables communication technology and long-term operation while maintaining relatively low power consumption. BLE devices can communicate with the outside world using either broadcast or connection mechanisms. Furthermore, BLE technology supports fast search and connection methods, with variable connection time intervals, allowing for almost instantaneous connection to smartphones, significantly reducing waiting time.

[0052] In one embodiment of this invention, to achieve accurate collection and analysis of user sweat data, thereby obtaining key information about the various components in the sweat, this data will be transmitted to the APP in real time and presented in an intuitive manner. The APP of this invention is designed with three core modules: a gout self-test module, a history module, and a personal basic information module, to meet the diverse needs of users.

[0053] Gout Self-Test Module: The core function of this module is to connect to a smartwatch and receive and analyze sweat data collected by the watch in real time. Users need to ensure that the watch and the APP are successfully connected to start the self-test function and quickly obtain a detailed sweat analysis report on the APP, including component content, trends, and possible health suggestions.

[0054] Historical Records Module: In this module, users can easily view past analysis records, including the results and time of each gout self-test, along with related health advice. This feature not only helps users understand the trends in their health status and comprehensively review their health condition, but also provides valuable reference information for doctors to develop more personalized health management plans.

[0055] Personal Basic Information Module: Users can enter and edit their basic information in this module, such as name, age, gender, and contact information. This information will serve as an important basis for user identification and health data analysis. Simultaneously, users can export data to other health management platforms or medical institutions, achieving data interconnection and sharing.

[0056] This application provides a wearable, continuous dynamic uric acid intelligent monitoring device. It collects sweat by closely adhering to the skin and interconnects with an upper microfluidic gel layer, achieving effective sweat transfer. An upper limit for the iontophoresis current is set as a safety mechanism to effectively avoid the corrosion of electrodes and the strong skin irritation, overheating, and device burns caused by traditional iontophoresis therapy. This allows for continuous sweat collection and replenishment throughout the day, both at rest and during exercise. The collected sweat enters the upper microfluidic gel layer, which includes a sweat inflow channel and a detection area. Sweat flows through the sweat inflow channel into the detection area. The core detection area utilizes electrochemical principles, hereinafter referred to as the electrochemical sensing unit, and employs a three-electrode system. Flexible electrodes are fabricated on a transparent PET film using a screen printing process. In addition to the point-by-point coating technology for three-electrode cross-sections for short-circuit protection, a soft polydimethylsiloxane layer is covered on the conductive substrate. The electrodes manufactured using screen printing technology exhibit excellent flexibility and can be physically bent. Based on electrochemical detection technology, this invention utilizes the redox reaction between electrodes and chemical components in sweat. By measuring the electrical signals such as current, potential, or conductance generated by the reaction, it achieves quantitative analysis of multiple components in sweat, aligning with the development needs of wearable sensor technology. Furthermore, this invention incorporates a smart chip to further enhance the functionality of wearable devices, achieving a single-chip solution integrating low-power Bluetooth technology and TTS voice synthesis. This allows the wearable device to connect with various smart devices via Bluetooth, enabling data transmission and voice broadcasting. Through a designed and developed app, users can receive personalized health reminders and suggestions via text and voice. Moreover, with the built-in smart chip, this invention can monitor users' heart rate, steps, sleep quality, and other indicators in real time. Upon detecting abnormalities, it alerts users via voice broadcast and provides personalized suggestions based on the user's daily activities and uric acid levels, encouraging appropriate exercise and dietary adjustments to maintain a healthy physiological state.

[0057] In the description of this invention, it should be understood that the terms "longitudinal", "lateral", "up", "down", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing this invention, and are not intended to indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this invention.

[0058] The above embodiments are merely descriptions of preferred embodiments of the present invention and are not intended to limit the scope of the present invention. Various modifications and improvements made by those skilled in the art to the technical solutions of the present invention without departing from the spirit of the present invention should fall within the protection scope defined by the claims of the present invention.

Claims

1. A wearable, continuous, dynamic, intelligent uric acid monitoring device, characterized in that, include: The device itself is worn on the human body; The device body is provided with a skin adhesive layer, a biomimetic microfluidic gel layer and an integrated ion electroosmotic electrode substrate arranged sequentially from the outside to the inside. The skin adhesive layer is in contact with human skin. The biomimetic microfluidic gel layer is used to collect sweat from human skin and guide the sweat to the detection area on the biomimetic microfluidic gel layer. An electrochemical detection unit is provided on the integrated ion electroosmotic electrode substrate, which is used to detect the sweat in the detection area. An analysis and feedback module is installed on the device body. The data detected by the electrochemical detection unit is analyzed by the analysis and feedback module, and the final result is fed back to the wearer.

2. The wearable continuous dynamic uric acid intelligent monitoring device according to claim 1, characterized in that: The skin adhesive layer includes a skin adhesive plate (2) that is attached to the wearer's skin (1). The skin adhesive plate (2) has a sweat inflow area (3) for transferring sweat. The sweat inflow area (3) is used to collect sweat from the wearer.

3. The wearable continuous dynamic uric acid intelligent monitoring device according to claim 2, characterized in that: The biomimetic microfluidic gel layer includes an electrochemical monitoring region (7). The top of the electrochemical monitoring region (7) is connected to several sweat inflow channels (8). Sweat enters the electrochemical monitoring region (7) through the sweat inflow channels (8). The bottom of the electrochemical monitoring region (7) is connected to several sweat evaporation channels (6) through several sweat outflow channels (17). Waste sweat flows into the sweat evaporation channels (6) through the sweat outflow channels (17) and evaporates and is discharged.

4. The wearable continuous dynamic uric acid intelligent monitoring device according to claim 3, characterized in that: The integrated iontophoresis electrode substrate includes an electrode plate (10), on which a temperature monitoring working electrode (14), an iontophoresis electrode (16), a reference electrode (15), a counter electrode (12), and multiple working electrodes (13) are connected by wires (11). The multiple working electrodes (13) are used to detect glucose, uric acid, and pH value in sweat, respectively.

5. The wearable continuous dynamic uric acid intelligent monitoring device according to claim 3, characterized in that: It also includes an ion-electro-osmotic hydrogel layer (5) disposed between the sweat inflow channel (8) and the electrochemical monitoring area (7).

6. The wearable continuous dynamic uric acid intelligent monitoring device according to claim 1, characterized in that: The device body includes a dial (18), with watch straps (20) connected to both sides of the dial (18), and a detection groove (19) provided on the dial (18).

7. A wearable continuous dynamic uric acid intelligent monitoring device according to claim 4, characterized in that: The analysis feedback module includes a signal processing module and a transmission module. The sensor acquisition signal terminal of the signal processing module is connected to the electrode plate (10). The signal processing module processes the acquired glucose, uric acid, pH value and temperature signals, and sends the processed result signal to the transmission module.

8. The wearable continuous dynamic uric acid intelligent monitoring device according to claim 7, characterized in that: The signal processing module includes a sensor signal acquisition terminal, an amplifier module, an analog-to-digital converter module, a communication module, and a processor module.

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