An integrated microneedle array biomarker detection patch device

Abstract

The application belongs to the technical field of medical treatment, and particularly relates to an integrated microneedle array biomarker detection patch device, which comprises a shell, a printed circuit board assembly and metal microneedles. The printed circuit board assembly is arranged in the shell. The input end signal of the printed circuit board assembly is connected to the root of the metal microneedle through a conductive elastic connecting body. The printed circuit board assembly is provided with a signal output port. The head of the metal microneedle penetrates through the bottom of the shell. The distance from the head of the metal microneedle to the lower surface of the shell is arranged in the range of 0.4 to 2 mm. The head of the metal microneedle is provided with a sensing assembly, and the sensing assembly is signal-connected to the metal microneedle. The problems of reducing the size of the whole device, making the device more compact and thin, facilitating the user to wear, and avoiding the use of complex auxiliary implantation tools for assistance are solved.

Description

Technical Field

[0001] This application belongs to the field of medical technology, specifically an integrated microneedle array biomarker detection patch device. Background Technology

[0002] In the healthcare field, continuous, real-time monitoring of biomarkers in the human body using wearable devices has become an important development direction. Biomarkers are measurable indicators that can mark physiological or pathological processes, covering metabolic indicators (such as glucose, lactate, and ketone bodies), electrolytes, drug metabolites, and various protein markers. Among them, continuous glucose monitoring (CGM) is the most mature application—it replaces the traditional finger-prick blood sampling method, improving the patient experience; it accurately and in real-time monitors the concentration of target analytes, helping patients to adjust their diet, exercise, and treatment plans in a timely manner. Currently, a common method in related technologies is to insert microneedles into the skin to obtain the analyte in the interstitial fluid of the dermis, and then use biosensors to convert it into an electrical signal, thereby calculating the concentration of the target substance in real time.

[0003] However, practical applications face numerous challenges. First, the implantation depth of the microneedle sensor needs to be controlled between 0.3 and 2 mm. If implanted too deep, it will touch nerve endings and capillaries, causing not only intense pain but also bleeding, increasing patient suffering and risk. If implanted too shallow, it cannot effectively obtain the target analytes in the dermal interstitial fluid, affecting detection accuracy and rendering the monitoring data inaccurate and unreliable, thus failing to provide effective guidance for patient health management and clinical diagnosis.

[0004] To reduce sensor size and minimize user discomfort, especially pain, the use of extremely fine microneedles is desired. Currently, microneedles are mostly made of silicon-based materials or polymers, fabricated through complex processes such as photolithography, etching, and micromolding, resulting in high costs. These microneedles also have some drawbacks: firstly, their structure has poor rigidity and is prone to breakage; to ensure stability during use, they often require larger sizes, which increases user discomfort; secondly, these microneedles have poor biocompatibility, potentially triggering immune responses and posing a potential threat to patient health. Furthermore, when using the same microneedle platform to detect different types of biomarkers, the requirements for the microneedle surface sensing functions vary depending on the target (e.g., enzyme electrodes, immunoelectrodes, electrochemical sensing), and existing integrated microneedle structures, once fabricated, are difficult to flexibly adapt to the needs of various detection scenarios.

[0005] To improve the user experience, biomarker detection devices have been continuously miniaturized, with wearable patch microneedle array devices being a product form that has garnered significant attention in the industry. However, current patch microneedle array biomarker detection devices (including but not limited to multi-analyte detection products such as blood glucose, lactate, and ketone bodies) also have some drawbacks. These devices typically require auxiliary implantation tools, which not only increases the product's cost but also complicates the operation process. For patients, this complex operation can lead to inconvenience and reduce the product's acceptability. Furthermore, the use of auxiliary implantation tools increases the overall size and weight of the product, affecting the patient's wearing experience and limiting the expansion of this technology into more detection scenarios.

[0006] In summary, existing microneedle array technology has many shortcomings in terms of microneedle material, implantation method, and overall structural design, and cannot meet the market's demand for upgraded wearable multianalyte detection products. Therefore, developing an integrated microneedle array biomarker detection patch device that can solve the above problems is of great practical significance. Summary of the Invention

[0007] The purpose of this application is to address the shortcomings of existing technologies by using a method of setting sensing components on metal microneedles, eliminating the need for auxiliary implantation tools. This solves the problems of reducing the overall size of the device, making it smaller and thinner, making it easier for users to wear, and avoiding the need for complex auxiliary implantation tools.

[0008] To achieve the above objectives, the following technical solution is adopted: An integrated microneedle array biomarker detection patch device includes a housing, a printed circuit board assembly, and metal microneedles. The printed circuit board assembly is disposed inside the housing. The input end of the printed circuit board assembly is connected to the root of the metal microneedles through a conductive elastic connector. The printed circuit board assembly is provided with a signal output port. The head of the metal microneedle penetrates through the bottom of the housing. The distance from the head of the metal microneedle to the lower surface of the housing is set in the range of 0.4 to 2 mm. The head of the metal microneedle is provided with a sensing component, which is signal-connected to the metal microneedle.

[0009] Preferably, the central area of ​​the bottom wall of the housing has a plurality of through holes, and a non-conductive fixing post is coaxially fixed between the two ends of the metal microneedle. One of the non-conductive fixing posts is coaxially installed in one of the through holes, and the root of each metal microneedle is connected to the input signal of the printed circuit board assembly through a conductive elastic connector.

[0010] Preferably, there are three groups of metal microneedles, and the root of each group of metal microneedles is connected to the input signal of the printed circuit board assembly through a conductive elastic connector.

[0011] Preferably, the sensing component on the first group of metal microneedles serves as a reference electrode RE. The sensing component on the first group of metal microneedles includes a first insulating base film, a first silver layer, and a first outer film. The lower portion of each metal microneedle in the first group of metal microneedles is sequentially covered by the first insulating base film, the first silver layer, and the first outer film from the inside to the outside. The upper end of the first silver layer is higher than the upper end of the first insulating base film. The upper end of the first silver layer is in contact with the upper portion of the corresponding metal microneedle in the first group of metal microneedles. The first outer film is a semi-permeable membrane.

[0012] Preferably, the sensing component on the second group of metal microneedles serves as the counter electrode (CE). The sensing component on the second group of metal microneedles includes a second insulating base film, a second noble metal or inert metal conductive layer, and a second outer film. The lower section of each metal microneedle in the second group of metal microneedles is sequentially covered from the inside to the outside with the second insulating base film, the second noble metal or inert metal conductive layer, and the second outer film. The upper end of the second noble metal or inert metal conductive layer is higher than the upper end of the second insulating base film. The upper end of the second noble metal or inert metal conductive layer is in contact with the upper section of the corresponding metal microneedle in the second group of metal microneedles. The second outer film is a semi-permeable membrane.

[0013] Preferably, the sensing component on the third group of metal microneedles serves as the working electrode WE. The sensing component on the third group of metal microneedles includes a third insulating base film, a third noble metal or inert metal conductive layer, a specific recognition layer, and a third outer film. The lower section of each metal microneedle in the third group of metal microneedles is sequentially covered from the inside to the outside with the third insulating base film, the third noble metal or inert metal conductive layer, the specific recognition layer, and the third outer film. The upper end of the third noble metal or inert metal conductive layer is higher than the upper end of the third insulating base film. The upper end of the third noble metal or inert metal conductive layer is in contact with the upper section of the corresponding metal microneedle in the third group of metal microneedles. The third outer film is a semi-permeable membrane.

[0014] Preferably, the printed circuit board assembly integrates a microcontroller unit (MCU), Bluetooth BLE, an analog front-end (AFE), and an NFC antenna coil. The Bluetooth BLE is a signal output port provided on the printed circuit board assembly, the analog front-end (AFE) is connected to the sensing component, and the NFC antenna coil is used to wake up the Bluetooth BLE through the MCU.

[0015] Preferably, it also includes a button battery and non-woven fabric, wherein the button battery is disposed on the printed circuit board assembly to provide power to the microcontroller unit (MCU), Bluetooth BLE, and analog front-end (AFE).

[0016] Preferably, the housing includes an upper shell, a lower shell, and a waterproof sealing structure. The upper shell and the lower shell are fastened together, and the fastening point of the upper shell and the lower shell is provided with a waterproof sealing structure. The printed circuit board assembly and the button battery are both located in the cavity formed by the fastening of the upper shell and the lower shell.

[0017] Preferably, the lower surface of the lower shell is provided with non-woven fabric, and the side of the non-woven fabric facing away from the lower shell is provided with double-sided adhesive tape.

[0018] Preferably, both the upper and lower shells are made of medical-grade polymer material, and the upper and lower shells are fixed together by ultrasonic welding.

[0019] Compared with the prior art, the beneficial effects of the technical solution of this application are: 1. The sensing components and implantation function are integrated onto a solid metal microneedle, and biomarker detection and emission are designed as a single unit. This highly integrated design not only significantly reduces the overall size of the device, making it smaller and thinner for easier wear and a significantly improved user experience, but also eliminates the need for complex implantation tools. Eliminating these tools reduces product costs and simplifies the operation process, allowing patients to more easily and conveniently complete the testing process themselves, thus improving the product's usability and accessibility.

[0020] 2. Regarding the materials and properties of metal microneedles, using solid metal microneedles instead of silicon and polymer needles offers numerous advantages: Solid metal microneedles have a robust structure, eliminating the need to increase size to maintain structural strength, thus meeting the requirement for smaller needle tips. Simultaneously, their excellent biocompatibility effectively reduces the risk of immune responses to the microneedles, ensuring patient safety and comfort. The extremely fine diameter and sharp tip of the metal microneedles allow for painless and minimally invasive implantation via finger pressure, significantly reducing patient discomfort during the testing process and further enhancing the user experience.

[0021] 3. In terms of detection performance and stability, the carefully designed multi-electrode metal microneedle array layout and the composite coating design on the surface of the metal microneedles effectively improve the accuracy and stability of the sensing component.

[0022] 4. In terms of scalability, the entire device of this application is designed to construct an array using an independent combination of metal microneedles. With the product hardware remaining basically unchanged, by simply replacing a few metal microneedles with different surface-specific recognition coatings, the detection of various analytes such as lactic acid and ketones can be rapidly expanded, making it applicable to a wide range of scenarios.

[0023] In summary, this application, through innovative design and technological application, has achieved significant progress in reducing costs, simplifying operations, improving detection accuracy, and enhancing user comfort. It provides a more advantageous solution for the field of continuous biomarker detection (including CGM blood glucose detection and other analyte detection), and has important clinical application value and market promotion prospects. Attached Figure Description

[0024] Figure 1 This is a schematic diagram of the structure of this application; Figure 2 for Figure 1 A schematic diagram of the bottom structure; Figure 3 This is an exploded view of this application; Figure 4 This is a schematic diagram of the present application; Figure 5 This is a diagram showing the arrangement of the metal microneedles in this application; Figure 6 This is a schematic diagram of the structure of the sensing component designed on the third group of metal microneedles in this application; Figure 7 This is a schematic diagram of the structure of the sensing component designed on the first group of metal microneedles in this application; Figure 8 This is a schematic diagram of the structure of the sensing component designed on the second group of metal microneedles in this application; Figure 9 This is a schematic diagram showing the assembly relationship between a single microneedle and a conductive elastic connector in this application.

[0025] The components include: 1. Printed circuit board assembly; 2. Metal microneedles; 3. Non-conductive fixing posts; 4. First insulating base film; 5. First silver layer; 6. First outer film; 7. Second insulating base film; 8. Second noble metal or inert metal conductive layer; 9. Second outer film; 10. Third insulating base film; 11. Third noble metal or inert metal conductive layer; 12. Specific recognition layer; 13. Microcontroller unit (MCU); 14. Bluetooth BLE; 15. Analog front-end (AFE); 16. NFC antenna coil; 17. Button battery; 18. Non-woven fabric; 19. Upper shell; 20. Lower shell; 21. Third outer film; and 130. Conductive elastic connector. Detailed Implementation

[0026] This embodiment uses glucose detection as an example for illustration, but those skilled in the art will know that by changing the material of the specific recognition layer, the detection of other biomarkers can be achieved.

[0027] Reference Figures 1-9An integrated microneedle array biomarker detection patch device includes a housing, a printed circuit board assembly 1, and metal microneedles 2. The printed circuit board assembly 1 is disposed inside the housing. The input end of the printed circuit board assembly 1 is connected to the root of the metal microneedles 2 through a conductive elastic connector 130. The printed circuit board assembly 1 is provided with a signal output port. The head of the metal microneedles 2 penetrates through the bottom of the housing. The distance from the head of the metal microneedles 2 to the lower surface of the housing is set in the range of 0.4 to 2 mm. The head of the metal microneedles 2 is provided with a sensing component, which is signal-connected to the metal microneedles.

[0028] In this embodiment, during use, the user presses the shell vertically with their fingers, applying moderate pressure. Under pressure, the solid metal microneedles 2, with their structural strength and sharp tips, directly pierce the dermis layer of the skin. The implantation depth can be stably controlled within a preset depth range suitable for the dermis layer. The head of the metal microneedles 2 has a conical structure, and its extremely fine diameter and sharp tip design ensure that the metal microneedles 2 have good strength characteristics, do not break easily, and have low insertion resistance, avoiding contact with nerve endings and capillaries, thus achieving painless, non-invasive, and bloodless minimally invasive implantation. The distance from the head of the metal microneedles 2 to the lower surface of the shell is set within the range of 0.4 to 2 mm, ensuring that the working area of ​​the metal microneedles 2 effectively reaches the dermis layer of the skin after implantation and makes full contact with the interstitial fluid. The sensing component at the head of the metal microneedle 2 makes full contact with the analyte (such as glucose) in the interstitial fluid, and then converts it into an electrical signal through an electrochemical reaction, which is then transmitted to the metal microneedle 2. The metal microneedle 2 then transmits the signal to the printed circuit board assembly 1, which transmits the signal (value) to the user's mobile phone or other display terminal through the output port, thereby obtaining the concentration value of the analyte.

[0029] As a preferred embodiment, the central region of the bottom wall of the housing has several through holes. Non-conductive fixing posts 3 are coaxially fixed between the two ends of each metal microneedle 2, with each non-conductive fixing post 3 coaxially installed in one of the through holes. The root of each metal microneedle 2 is connected to the input signal terminal of the printed circuit board assembly 1 via a conductive elastic connector 130. This design achieves positioning and insulation isolation of the microneedle array, ensuring the stability of the microneedles during use. In practical applications, an appropriate number of metal microneedles 2 are arranged in a regular rectangular array. This rectangular array consists of a reasonable number of rows and columns, with adjacent metal microneedles 2 maintaining a suitable center-to-center distance. The array has through holes of a specific diameter. Regarding the rectangular array layout, the reference electrode RE and the counter electrode CE are placed at specific corner positions on one side of the array, while the working electrode WE is placed in the remaining positions. This arrangement helps improve the accuracy and stability of the sensing component, enabling the electrodes to work collaboratively and obtain more ideal target analyte concentration detection results.

[0030] As a preferred embodiment, the metal microneedles 2 are arranged in three groups. The root of each group of metal microneedles 2 is connected to the input signal terminal of the printed circuit board assembly 1 via a conductive elastic connector 130, so that the signal collected by the sensing component on each metal microneedle 2 can be stably transmitted to the printed circuit board assembly 1. In this embodiment, the conductive elastic connector is made of self-conductive silicone. As other optional solutions, one or more elastic pressing materials such as spring probes and metal spring sheets can also be used. Their function is to establish a reliable elastic electrical contact between the root of the metal microneedle and the PCB.

[0031] In a preferred embodiment, the sensing component on the first group of metal microneedles serves as a reference electrode RE. This sensing component includes a first insulating base film 4, a first silver layer 5, and a first outer film 6. The lower portion of each metal microneedle 2 in the first group is sequentially covered from the inside out by the first insulating base film 4, the first silver layer 5, and the first outer film 6. The upper end of the first silver layer 5 is higher than the upper end of the first insulating base film 4, and the upper end of the first silver layer 5 contacts the upper portion of the corresponding metal microneedle 2 in the first group. The first outer film 6 is a semi-permeable membrane. The first insulating base film 4 electrically insulates the lower portion of the metal microneedle 2 from the first silver layer 5. The upper end of the first silver layer 5 is higher than the upper end of the first insulating base film 4 and contacts the exposed portion of the corresponding upper portion of the metal microneedle 2 to form an electrical connection. In this embodiment, the first insulating base film 4 is specifically a PI insulating base film. As other optional solutions, the insulating base film can also be a modified epoxy resin film, a flexible insulating coating, or other materials with good insulation properties and biocompatibility. The first silver layer 5, after chlorination, forms a reference electrode, providing a stable reference potential for the working electrode WE. A stable reference potential is required for the reference electrode, and silver / silver chloride is currently the most mature reference electrode material system; therefore, a silver layer is selected in this embodiment. However, in other alternative solutions, other conductive materials capable of providing a stable reference potential can also be used. The first outer membrane 6 is a semi-permeable membrane, allowing electrolyte ions in the tissue fluid to pass through to maintain the ion conduction pathway, while simultaneously blocking macromolecular substances from contaminating the silver layer.

[0032] In a preferred embodiment, the sensing component on the second group of metal microneedles serves as the counter electrode (CE). This sensing component includes a second insulating base film 7, a second noble metal or inert metal conductive layer 8, and a second outer film 9. The lower portion of each metal microneedle 2 in the second group is sequentially covered from the inside out by the second insulating base film 7, the second noble metal or inert metal conductive layer 8, and the second outer film 9. The upper end of the second noble metal or inert metal conductive layer 8 is higher than the upper end of the second insulating base film 7, and the upper end of the second noble metal or inert metal conductive layer 8 contacts the upper portion of the corresponding metal microneedle 2 in the second group. The second outer film 9 is a semi-permeable membrane. Specifically, the second insulating base film 7 electrically insulates the lower portion of the metal microneedle 2 from the second noble metal or inert metal conductive layer 8, and the upper end of the second noble metal or inert metal conductive layer 8 is higher than the upper end of the second insulating base film 7 and contacts the exposed portion of the corresponding upper portion of the metal microneedle 2 to form an electrical connection. In this embodiment, the second insulating base film 7 is specifically a PI insulating base film. Alternatively, the second insulating base film 7 can also be made of materials with good insulation properties and biocompatibility, such as modified epoxy resin film or flexible insulating coating. The second noble metal or inert metal conductive layer 8 is specifically a gold layer. Alternatively, the second noble metal or inert metal conductive layer 8 can also be made of platinum, iridium, titanium, chromium, nickel, or their alloys. The second noble metal or inert metal conductive layer 8 serves as the counter electrode, forming a current loop with the working electrode WE in the potentiostat circuit. The second outer membrane 9 is a semi-permeable membrane, allowing electrolyte ions in the tissue fluid to pass through to maintain the ion conduction pathway, while preventing the adsorption of large molecules in the tissue fluid on the gold layer surface, which could lead to electrode passivation.

[0033] In a preferred embodiment, the sensing component in the third group of metal microneedles serves as the working electrode WE. The sensing component on the third group of metal microneedles includes a third insulating base film 10, a third noble metal or inert metal conductive layer 11, a specific recognition layer 12, and a third outer film 21. The lower section of each metal microneedle 2 in the third group of metal microneedles is sequentially covered from the inside to the outside with the third insulating base film 10, the third noble metal or inert metal conductive layer 11, the specific recognition layer 12, and the third outer film 21. The upper end of the third noble metal or inert metal conductive layer 11 is higher than the upper end of the third insulating base film 10. The upper end of the third noble metal or inert metal conductive layer 11 contacts the exposed upper section of the corresponding metal microneedle 2 in the third group of metal microneedles to form an electrical connection. In this embodiment, the third insulating base film 10 is specifically a PI insulating base film. Alternatively, the third insulating base film 10 can also be made of materials with good insulation properties and biocompatibility, such as modified epoxy resin film or flexible insulating coating. The third noble metal or inert metal conductive layer 11 is specifically a gold layer. Alternatively, the third noble metal or inert metal conductive layer 11 can be made of platinum, iridium, titanium, chromium, nickel, or their alloys. The specific recognition layer 12 is specifically a glucose oxidase layer for recognizing glucose. Alternatively, the specific recognition layer 12 can be replaced with a specific recognition material capable of recognizing biochemical markers such as lactic acid and ketone bodies, depending on the analyte, to achieve the detection of multiple analytes. In continuous glucose detection, the glucose oxidase layer reacts electrochemically with glucose in the tissue fluid on the surface of the gold layer, releasing electrons and generating a current signal proportional to the glucose concentration. This current is transmitted through the gold layer and metal microneedles 2 to the printed circuit board assembly 1 for processing and conversion into a glucose concentration value. The third outer membrane 21 is a semi-permeable membrane used to control the diffusion rate of glucose and oxygen, block interfering substances, and maintain a stable microenvironment for the enzyme layer.

[0034] As a preferred embodiment, the printed circuit board assembly 1 integrates a microcontroller unit (MCU) 13, a Bluetooth BLE 14, an analog front-end (AFE) 15, and an NFC antenna coil 16. The Bluetooth BLE 14 is a signal output port on the printed circuit board assembly 1. The analog front-end (AFE) 15 is connected to the sensing component, and the NFC antenna coil 16 is used for Bluetooth wake-up. The Bluetooth BLE 14 wirelessly transmits the detected analyte concentration value to a user terminal, such as a smartphone or smartwatch, for display, allowing users to easily monitor their health. The analog front-end (AFE) 15, through a series of operations including amplification, filtering, and voltage regulation, converts the weak current signal detected by the sensor component into a signal format suitable for processing by the MCU main control module. This improves signal quality and stability, ensuring the MCU main control module receives accurate and reliable signals, thus providing an accurate data foundation for subsequent analyte concentration calculations. The NFC device and antenna coil are used to enable Bluetooth BLE 14 wake-up. This application sets the Bluetooth BLE14 to a sleep state at the factory, which allows the battery inside the application to have a shelf life of more than one year before the product is put into use. Bluetooth can only be woken up by the NFC antenna coil of the mobile phone NFC coil sensing patch device when the user uses the application, and the monitored analyte concentration value is sent to the user terminal.

[0035] As a preferred embodiment, a button battery 17 is also included, which is disposed on the printed circuit board assembly 1. Its electrical performance and size design ensure that it can stably and continuously provide power to the microcontroller unit MCU 13, Bluetooth BLE 14, and analog front-end AFE 15, so as to ensure the normal operation of each component and realize functions such as detection and data transmission.

[0036] In a preferred embodiment, the housing includes an upper shell 19, a lower shell 20, and a waterproof sealing structure. The upper shell 19 and the lower shell 20 are fastened together, and the fastening point of the upper shell 19 and the lower shell 20 is provided with a waterproof sealing structure. The printed circuit board assembly 1 and the button battery 17 are both located within the cavity formed by the fastening of the upper shell 19 and the lower shell 20. The waterproof sealing structure effectively prevents the intrusion of sweat and moisture, protecting the internal circuitry and sensor assembly for stable operation.

[0037] As a preferred embodiment, a non-woven fabric 18 is provided on the lower surface of the lower shell 20, and a double-sided adhesive tape is provided on the side of the non-woven fabric 18 facing away from the lower shell 20.

[0038] The non-woven fabric 18 is used to improve skin fit and comfort, while the medical pressure-sensitive double-sided tape is used to firmly adhere the patch to the skin surface, preventing it from falling off during use. Windows are opened in the middle of the non-woven fabric and the pressure-sensitive double-sided tape, allowing the microneedle array to pass smoothly through and penetrate the dermis. In use, the user first peels off the protective film of the double-sided tape on the non-woven fabric 18 at the bottom of the patch, then gently applies and positions the metal microneedles 2 to a flat area of ​​skin such as the upper arm or abdomen, completing the preparation for wearing.

[0039] As a preferred embodiment, both the upper shell 19 and the lower shell 20 are made of medical-grade polymer material. To effectively prevent the intrusion of sweat and moisture and ensure the normal operation of the internal electronic components, the upper shell 19 and the lower shell 20 need to be connected in a specific way to form an integrated sealed cavity. Ultrasonic welding is a feasible connection method that can achieve a reliable seal. Other connection processes that can achieve the same sealing effect, such as heat fusion bonding and chemical bonding of medical-grade polymer materials, are also within the scope of this application.

Claims

1. An integrated microneedle array biomarker detection patch device, characterized in that, The device includes a housing, a printed circuit board assembly (1), and a metal microneedle (2). The printed circuit board assembly (1) is disposed inside the housing. The input signal of the printed circuit board assembly (1) is connected to the root of the metal microneedle (2) through a conductive elastic connector (130). The printed circuit board assembly (1) is provided with a signal output port. The head of the metal microneedle (2) penetrates the bottom of the housing. The distance from the head of the metal microneedle (2) to the lower surface of the housing is set in the range of 0.4 to 2 mm. The head of the metal microneedle (2) is provided with a sensing component, and the sensing component is connected to the metal microneedle (2) for signal transmission.

2. The integrated microneedle array biomarker detection patch device according to claim 1, characterized in that: The bottom wall of the housing has a number of through holes in the center area. Non-conductive fixing posts (3) are coaxially fixed between the two ends of the metal microneedles (2). One non-conductive fixing post (3) is coaxially installed in one of the through holes. The root of each metal microneedle (2) is connected to the input terminal signal of the printed circuit board assembly (1) through a conductive elastic connector (130).

3. The integrated microneedle array biomarker detection patch device according to claim 2, characterized in that: The metal microneedles (2) are in three groups, and the root of each group of metal microneedles (2) is connected to the input signal of the printed circuit board assembly through a conductive elastic connector (130).

4. The integrated microneedle array biomarker detection patch device according to claim 3, characterized in that: The sensing components on the first group of metal microneedles serve as reference electrodes RE. The sensing components on the first group of metal microneedles include a first insulating base film (4), a first silver layer (5), and a first outer film (6). The lower part of each metal microneedle (2) in the first group of metal microneedles is covered with the first insulating base film (4), the first silver layer (5), and the first outer film (6) from the inside to the outside. The upper end of the first silver layer (5) is higher than the upper end of the first insulating base film (4). The upper end of the first silver layer (5) is in contact with the upper part of the corresponding metal microneedle (2) in the first group of metal microneedles (2). The first outer film (6) is a semi-permeable membrane.

5. The integrated microneedle array biomarker detection patch device according to claim 3, characterized in that: The sensing components on the second group of metal microneedles serve as counter electrodes (CE). The sensing components on the second group of metal microneedles include a second insulating base film (7), a second noble metal or inert metal conductive layer (8), and a second outer film (9). The lower section of each metal microneedle (2) in the second group of metal microneedles is covered from the inside to the outside with the second insulating base film (7), the second noble metal or inert metal conductive layer (8), and the second outer film (9). The upper end of the second noble metal or inert metal conductive layer (8) is higher than the upper end of the second insulating base film (7). The upper end of the second noble metal or inert metal conductive layer (8) is in contact with the upper section of the corresponding metal microneedle (2) in the second group of metal microneedles. The second outer film (9) is a semi-permeable membrane.

6. The integrated microneedle array biomarker detection patch device according to claim 3, characterized in that: The sensing components on the third group of metal microneedles serve as the working electrode WE. The sensing components on the third group of metal microneedles include a third insulating base film (10), a third noble metal or inert metal conductive layer (11), a specific recognition layer (12), and a third outer film (21). The lower part of each metal microneedle (2) in the third group of metal microneedles (2) is covered from the inside to the outside with the third insulating base film (10), the third noble metal or inert metal conductive layer (11), the specific recognition layer (12), and the third outer film (21). The upper end of the third noble metal or inert metal conductive layer (11) is higher than the upper end of the third insulating base film (10). The upper end of the third noble metal or inert metal conductive layer (11) is in contact with the upper part of the corresponding metal microneedle (2) in the third group of metal microneedles (2). The third outer film (21) is a semi-permeable membrane.

7. The integrated microneedle array biomarker detection patch device according to claim 1, characterized in that: The printed circuit board assembly (1) integrates a microcontroller unit (MCU) (13), a Bluetooth BLE (14), an analog front-end (AFE) (15), and an NFC antenna coil (16). The Bluetooth BLE (14) is a signal output port provided on the printed circuit board assembly (1). The analog front-end (AFE) (15) is connected to the sensing component. The NFC antenna coil (16) is used to wake up the Bluetooth BLE (14) through the microcontroller unit (MCU) (13).

8. The integrated microneedle array biomarker detection patch device according to claim 1, characterized in that: It also includes a button battery (17) and a non-woven fabric (18). The button battery (17) is located on the printed circuit board assembly (1) and provides power to the microcontroller unit (MCU) (13), Bluetooth BLE (14), and analog front-end AFE (15).

9. The integrated microneedle array biomarker detection patch device according to claim 1, characterized in that: The housing includes an upper shell (19), a lower shell (20), and a waterproof sealing structure. The upper shell (19) and the lower shell (20) are fastened together. A waterproof sealing structure is provided at the fastening point of the upper shell (19) and the lower shell (20). The printed circuit board assembly (1) and the button battery (17) are both located in the cavity formed by the fastening of the upper shell (19) and the lower shell (20).

10. The integrated microneedle array biomarker detection patch device according to claim 9, characterized in that: The lower surface of the lower shell (20) is provided with non-woven fabric (18), and the side of the non-woven fabric (18) facing away from the lower shell (20) is provided with double-sided adhesive tape.

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