S100A9 sample sampling and detecting device containing microneedle array

Abstract

The invention relates to the technical field of medical detection, in particular to a microneedle array-containing S100A9 sample sampling and detecting device which comprises a base, a limiting column and a color developing assembly, the limiting column is fixedly connected to the top end of the base, and a working sliding groove for inserting the color developing assembly is formed between the limiting column and the base; a sampling groove is formed in the top end of the base, the inner bottom wall of the sampling groove is fixedly connected with a microneedle assembly used for puncturing the skin of a patient for sampling, and the top of the microneedle assembly communicates with a pretreatment assembly used for filtering an extracted sample; driving force is provided for the pretreatment assembly in the process that the color developing assembly is inserted into the working sliding groove, and the filtered sample is input into the color developing assembly to be detected. According to the invention, convenient sampling is realized through the microneedle assembly, and a sample is pertinently filtered by using the pretreatment assembly, so that macromolecular interference impurities such as cell debris and hemoglobin are effectively removed, the interference on S100A9 detection is reduced, and the accuracy and reliability of S100A9 detection are improved.

Description

Technical Field

[0001] This invention relates to the field of medical testing technology, specifically to an S100A9 sample sampling and testing device containing a microneedle array. Background Technology

[0002] S100A9 is an important member of the S100 calcium-binding protein family, with a molecular weight of approximately 14 kDa. It is widely expressed in immune cells such as neutrophils and monocytes, as well as epithelial cells. Its core function depends on calcium ion binding-mediated conformational changes, and it often forms a heterodimer with S100A8 (S100A8 / A9, also known as calprotectin) to exert its biological effects. Clinically, the detection of S100A9 has been applied to disease screening, disease monitoring, and efficacy evaluation. Commonly used methods include ELISA, immunochromatographic strips, and electrochemical sensors.

[0003] In existing testing methods, to further pursue convenient testing, devices using microneedle arrays for sampling and testing have emerged. This involves directly extracting tissue fluid or blood samples by puncturing the skin with microneedles, eliminating the need for additional blood collection steps. These devices can be integrated with test strips for instantaneous reactions. Generally, after the microneedles are inserted, the tissue fluid or blood sample is directly transferred to the test strip. However, the extracted samples often contain interfering substances such as cell debris, hemoglobin, and non-specific proteins. Some of these substances can also easily bind non-specifically to the test reagents, leading to false positives, false negatives, or quantitative deviations in the test results. This is especially true for markers like S100A9, which have low concentrations in the early stages of pathology. The interference from sample impurities can further amplify the detection error, making it difficult to meet the clinical requirements for accuracy and reliability.

[0004] Therefore, the present invention provides an S100A9 sample sampling and detection device containing a microneedle array to solve the above problems. Summary of the Invention

[0005] To address the aforementioned issues, this invention provides an S100A9 sample collection and detection device with a microneedle array. This device facilitates the extraction of skin tissue fluid or blood samples via the microneedle array. The pretreatment component precisely filters out interfering impurities such as cell debris and non-specific proteins, achieving integrated sampling, filtration, and detection. This enhances the accuracy and reliability of S100A9 detection, especially for low-concentration samples in the early stages of pathology, meeting the immediate detection needs for clinical disease screening and disease monitoring.

[0006] To achieve the above objectives, the technical solution of the present invention is as follows: an S100A9 sample sampling and detection device with a microneedle array, comprising a base, a limiting bar, and a colorimetric component for detecting the concentration of S100A9 in the sample. The limiting bar is fixedly connected to the top of the base and distributed along the circumference of the top of the base. A working groove for inserting the colorimetric component is formed between the limiting bar and the base.

[0007] The top of the base has a sampling slot, and the bottom wall of the sampling slot is fixedly connected to a microneedle assembly for piercing the patient's skin to take samples. The top of the microneedle assembly is connected to a pretreatment assembly for filtering the extracted samples. The pretreatment assembly is located in the sampling slot and the pretreatment assembly and the microneedle assembly are rotatably connected.

[0008] As the colorimetric component is inserted into the working chute, it provides driving force to the pretreatment component, allowing the filtered sample to be input into the colorimetric component for detection.

[0009] The technical principle of the above solution is as follows: In use, the bottom of the base is placed against the patient's skin, and then the colorimetric component is inserted into the working groove. The colorimetric component moves the pretreatment component and the microneedle component together towards the skin surface, allowing the microneedles to puncture the skin surface. The patient's tissue fluid or blood sample flows into the pretreatment component through the microneedle component, where the sample is filtered. The filtered liquid is then injected into the colorimetric component, where the S100A9 in the liquid undergoes a specific binding reaction with the colorimetric component, and a preliminary judgment is made through color development.

[0010] The above-mentioned solution offers the following advantages: Through the integrated design of the chromogenic component, microneedle component, and pretreatment component, this solution achieves integrated sampling, filtering, and detection, enhancing the convenience and practicality of the test. The chromogenic component simultaneously drives the microneedle to puncture the skin upon insertion, simplifying the operation and making it suitable for non-professionals or rapid clinical testing scenarios. The microneedle component, combined with an elastic buffer structure, allows for precise control of the puncture depth, reducing the risk of skin damage and improving safety and comfort. The pretreatment component specifically removes large molecular interference impurities such as cell debris and hemoglobin from the sample, effectively reducing false positive and false negative results caused by non-specific binding, especially ensuring the accuracy of detecting low concentrations of S100A9 in the early stages of pathology. The filtered sample is directly delivered to the detection area, reducing sample loss and contamination. The chromogenic reaction is intuitive and easy to interpret, balancing operational convenience and detection reliability, and meeting the diverse needs of clinical disease screening, disease monitoring, and home health management.

[0011] Furthermore, the microneedle assembly includes a needle carrier disk and several microneedles. The microneedles are all located at the bottom of the needle carrier disk. A collecting tube communicating with the microneedles is located at the top of the needle carrier disk. A driving disk is fixedly connected to the outer surface of the top of the collecting tube. An elastic component is wrapped around the outer surface of the needle carrier disk to buffer the sliding of the needle carrier disk along the central axis of the sampling groove.

[0012] Beneficial effects: The microneedle assembly integrates several microneedles through the needle carrier plate, which can realize multi-point synchronous sampling, significantly improve the collection efficiency and sample volume of tissue fluid or blood samples, and ensure sufficient supply for subsequent testing; the collection tube gathers the samples extracted by each microneedle, providing a structural basis for directional delivery to the pretreatment component.

[0013] Furthermore, the elastic component includes a positioning ring and several buffer springs. The positioning ring is detachably connected to the bottom wall of the sampling slot. The bottom ends of the buffer springs are all fixedly connected to the top ends of the positioning ring and are distributed in a ring array. The top ends of the buffer springs are all fixedly connected to the needle carrier plate.

[0014] Beneficial effects: The circular array of buffer springs in the elastic component provides uniform elastic support for the needle carrier disc, effectively cushioning the impact force during sliding, precisely controlling the depth of microneedle insertion into the skin, reducing the possibility of damage caused by over-puncture, and improving the comfort of the sampling process. The detachable design of the positioning ring facilitates quick replacement of the microneedle assembly, reducing usage and maintenance costs.

[0015] Furthermore, the top of the positioning ring has a ring array with several buckles, and the surface of the needle carrier plate has a ring groove corresponding to the buckles.

[0016] Beneficial effects: The combination of the buckle and the ring groove can precisely engage after the microneedle pierces the skin and reaches the preset depth, quickly locking the position of the microneedle component. This reduces the risk of changes in puncture depth or skin damage caused by microneedle displacement or shaking during sampling. At the same time, it ensures that the sample flows smoothly into the collection tube through the microneedle, preventing sample leakage or transmission interruption, and significantly improving sampling stability and reliability.

[0017] Furthermore, the pretreatment component includes a pretreatment tray with a temporary storage chamber inside. A columnar liquid outlet is fixedly connected to the top of the pretreatment tray. A filtration channel is provided inside the pretreatment tray, with the temporary storage chamber and the liquid outlet connected to both ends of the filtration channel, respectively.

[0018] The drive disc is located in the temporary storage cavity and slides in fit with the inner wall of the temporary storage cavity. The collecting tube rotates in fit with the pretreatment disc. A threaded cylinder is fixedly connected to the bottom end of the pretreatment disc. The threaded cylinder is threadedly connected to the top end of the needle carrier disc. The threaded cylinder and the temporary storage cavity are both located at the center of the pretreatment disc. When the pretreatment disc is in the initial position, the top end of the pretreatment disc is located above the top end of the base.

[0019] A filter membrane is installed inside the filter channel, and the molecular weight cutoff of the filter membrane is 30kDa to 50kDa.

[0020] Beneficial effects: The pretreatment component temporarily stores samples through a storage chamber, providing ample buffer space for filtration operations. The sliding engagement between the drive disk and the storage chamber converts the mechanical energy of the chromogenic component insertion into sample pushing force, ensuring efficient sample flow into the filtration channel. The central threaded connection design of the threaded cylinder ensures the coaxiality of the pretreatment disk and the needle carrier disk. The 30kDa–50kDa molecular weight cutoff filter membrane accurately intercepts interfering substances such as cell debris and large molecular proteins, while efficiently retaining the S100A9 target marker, reducing detection errors at the source. The directional connection between the outlet and the filtration channel enables precise delivery of purified samples. Combined with the overall structural design of the component, it balances filtration efficiency and separation accuracy, providing a core guarantee for the accuracy of subsequent detection.

[0021] Furthermore, a one-way lobe is provided inside the collecting tube, which allows the sample to flow from the collecting tube to the temporary storage chamber.

[0022] Beneficial effects: The one-way valve enables directional flow of samples from the collecting tube to the temporary storage chamber, effectively preventing sample backflow within the temporary storage chamber from contaminating the microneedle or skin puncture site, thus ensuring sample purity. It also prevents sample leakage and loss, ensuring that all collected samples enter the pretreatment stage, providing a stable sample supply for subsequent precise filtration and detection, and further improving the reliability of the device operation.

[0023] Furthermore, the color development component includes a T-shaped fixing shell with an observation groove at the top and a test strip for detecting S100A9 inside the observation groove. A guide groove is provided at the bottom of the fixing shell along the length of the fixing shell, and a sample hole is provided at the bottom of the fixing shell directly below the sample area of ​​the test strip, with the sample hole located at one end of the guide groove.

[0024] The guide groove is divided into four paths, starting from the sample hole: the first straight segment, the first arc segment, the second arc segment, and the second straight segment. The arc of the first arc segment is greater than that of the second arc segment, and the bending direction of the first arc segment is opposite to that of the second arc segment.

[0025] The thickness of the middle part of the fixed shell along the length direction is less than the thickness of the two ends of the fixed shell, and the first straight segment, the first arc segment and the second arc segment are all completely inside the middle part of the fixed shell;

[0026] When the fixed shell is inserted into the working slide, the liquid outlet slides sequentially along the second straight segment, the second arc segment, the first arc segment, and the first straight segment, and enters the sample hole.

[0027] Beneficial Effects: The T-shaped mounting shell ensures comfortable grip while providing intuitive visualization of test results via the top observation slot. The guide groove at the bottom of the mounting shell employs a four-segment path design. Through the orderly connection of the second straight segment, the second arc segment, the first arc segment (with a longer arc), and the first straight segment, it not only guides the outlet to slide smoothly but also, through the buffering effect of the arc segment and the difference in arc length, transforms the linear motion of the fixed insertion point into a smooth rotational driving force for the pretreatment disc. Simultaneously, the threaded connection between the pretreatment disc and the needle carrier disc enables the rotation and vertical sliding of the pretreatment disc, thereby altering the pressure changes within the temporary storage chamber and adapting to the sample input and output process. When the outlet slides along the guide groove to its endpoint, the filtered, pure sample can be directly and directionally dripped into the effective reaction area of ​​the test strip. This reduces detection failure or result deviation caused by sample offset, minimizes sample loss, and ensures sufficient specific binding reaction between the test strip and the S100A9.

[0028] Furthermore, the two side walls of the first straight section are symmetrically fixed with locking teeth near the sample hole, which are used to restrict the liquid outlet from sliding from the sample hole to the first straight section; the positioning ring is magnetically connected to the bottom wall of the sampling tank.

[0029] Beneficial effects: The symmetrical design of the locking teeth precisely engages the outlet when the fixing shell is withdrawn, forcing it to separate from the pretreatment tray and effectively preventing the pretreatment tray from rotating synchronously when the fixing shell is withdrawn. This prevents leakage of residual sample in the temporary storage chamber, contamination of the detection area or skin caused by rotation, ensures a smooth component separation process without interfering with completed detection reactions, and facilitates subsequent component repositioning, further improving the stability and operational safety of the device. The magnetic connection quickly and securely fixes the positioning ring to the bottom wall of the sampling slot, ensuring the installation stability of the needle carrier tray during sampling and preventing component displacement from affecting puncture accuracy or sample collection efficiency; only a slight external force is required to separate the positioning ring, allowing for easy removal and replacement of the needle carrier tray and pretreatment tray, making operation simple, efficient, and reducing maintenance costs.

[0030] Furthermore, the inner wall of the limiting rail is evenly distributed with several receiving grooves along the circumference, and each receiving groove has a slidably fitted positioning ball, and each positioning ball is abutted against the bottom of the receiving groove by a return spring; the side wall of the insertion end of the fixed shell is provided with several positioning grooves that correspond one-to-one with the positioning balls.

[0031] Beneficial effects: The one-to-one correspondence between several positioning balls and arc-shaped positioning grooves, with the help of the elastic force of the reset spring, can accurately engage after the color development component is inserted into place, achieving stable positioning of the fixed shell, ensuring that the liquid outlet and sample hole are always accurately aligned, reducing sample leakage or detection deviation caused by component displacement during the detection process.

[0032] Furthermore, a monitoring panel is provided on the surface of the base, the positioning balls are all made of metal and are electrically connected to the monitoring panel, the inner wall of the positioning groove is provided with a metal layer, the test paper is embedded with an electrode assembly, the electrode assembly includes a working electrode, a reference electrode and a counter electrode, the working electrode, the reference electrode and the counter electrode are electrically connected to the metal layer respectively; the monitoring panel has a built-in S100A9 monitoring system;

[0033] The S100A9 monitoring system includes: a signal acquisition module, a preprocessing module, an analysis and calibration module, an output module, and a monitoring module;

[0034] The signal acquisition module is used to acquire the electrical signal after the S100A9 is combined with the working electrode;

[0035] The preprocessing module is used to reduce noise, amplify, and convert the original electrical signal to generate digital signal data;

[0036] The analysis and calibration module is used to preset the calibration curve database of S100A9 concentration-signal intensity; it matches digital signal data with the calibration curve database to calculate the actual concentration of S100A9 in the sample; it can also automatically correct the curve parameters based on the data of blank samples and standard samples in the calibration curve database.

[0037] The output module is used to display the concentration results and qualitative conclusions of the analysis and calibration module in real time on the monitoring panel;

[0038] The monitoring module records the user's daily S100A9 concentration data by timestamp, establishing a personal testing database; it automatically integrates weekly S100A9 concentration data to form a trend curve, and uploads weekly S100A9 concentration change data, outlier records, and trend analysis results to the terminal server via wireless transmission technology; at the same time, it can mark and push early warning prompts for concentration data that is continuously high or changes abruptly within a week according to preset safety thresholds.

[0039] Beneficial Effects: This monitoring system achieves precise and convenient S100A9 detection through the coordinated operation of four modules. The signal acquisition module accurately captures the electrical signal after specific binding, laying the foundation for quantitative analysis; the preprocessing module effectively filters out interference noise and amplifies weak signals, ensuring data stability. The analysis and calibration module, relying on preset calibration curves and automatic correction functions, eliminates errors caused by batch differences in test strips and environmental changes, improving the detection accuracy of low-concentration S100A9; the output module presents quantitative results and qualitative conclusions in real time, eliminating the need for complex interpretation. The cooperation between the metal positioning ball and the metal layer of the positioning groove not only achieves mechanically stable positioning of the colorimetric component but also simultaneously completes the circuit conduction between the electrode component and the monitoring panel, eliminating the need for additional wiring. The electrochemical signal of the three-electrode system can be accurately transmitted to the built-in monitoring system, realizing the quantitative detection of S100A9 concentration and compensating for the accuracy shortcomings of simple colorimetry. The monitoring module establishes a personal detection database, accurately records the daily S100A9 concentration, and generates a weekly trend curve, intuitively presenting the indicator change pattern and providing data support for disease monitoring. The wireless transmission function enables remote data uploading, facilitating medical staff to monitor the user's health status in real time and adapting to remote monitoring scenarios.

[0040] Additional aspects and advantages of the invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention. Attached Figure Description

[0041] Figure 1 This is an isometric view of the base and limiting rail of an embodiment of the S100A9 sample sampling and detection device containing a microneedle array of the present invention.

[0042] Figure 2 This is a cross-sectional view of the base, limiting rail, microneedle assembly, and pretreatment assembly of an embodiment of the S100A9 sample sampling and detection device containing a microneedle array of the present invention.

[0043] Figure 3 This is a cross-sectional view of the base and limiting rail of an embodiment of the S100A9 sample sampling and detection device containing a microneedle array of the present invention.

[0044] Figure 4 This is an isometric view of the microneedle assembly and pretreatment assembly of an embodiment of the S100A9 sample sampling and detection device containing a microneedle array of the present invention.

[0045] Figure 5 This is an isometric view of the microneedle component and the elastic component of an embodiment of the S100A9 sample sampling and detection device containing a microneedle array of the present invention;

[0046] Figure 6 This is a side cross-sectional view of the microneedle assembly and pretreatment assembly of an embodiment of the S100A9 sample sampling and detection device containing a microneedle array of the present invention.

[0047] Figure 7 for Figure 6 Enlarged view of section A;

[0048] Figure 8 This is a front view of the colorimetric component of an embodiment of the S100A9 sample sampling and detection device containing a microneedle array of the present invention.

[0049] Figure 9 This is a schematic diagram of the back of the colorimetric component in an embodiment of the S100A9 sample sampling and detection device containing a microneedle array of the present invention.

[0050] Figure 10 This is a side cross-sectional view of the colorimetric component of an embodiment of the S100A9 sample sampling and detection device containing a microneedle array of the present invention.

[0051] Figure 11 This is a schematic diagram of the installation of the colorimetric component in an embodiment of the S100A9 sample sampling and detection device containing a microneedle array of the present invention.

[0052] The reference numerals in the accompanying drawings of the instruction manual include: 1. Base; 101. Sampling slot; 2. Monitoring panel; 3. Pretreatment tray; 301. Liquid outlet; 302. Filtration channel; 303. Filtration membrane; 304. Temporary storage chamber; 305. Threaded cylinder; 4. Limiting bar; 401. Positioning ball; 5. Needle carrier tray; 501. Microneedle; 502. Collector tube; 503. Drive disc; 504. Slot; 6. Positioning ring; 601. Buffer spring; 602. Buckle; 7. Fixing shell; 701. Test paper; 702. Sample hole; 703. First straight segment; 704. First arc segment; 705. Second arc segment; 706. Second straight segment; 8. Strap. Detailed Implementation

[0053] The technical solution of the present invention will now be clearly and completely described with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. 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.

[0054] In the description of this invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing the invention and for simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on the invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0055] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0056] The following detailed description illustrates the specific implementation method:

[0057] Example 1:

[0058] As attached Figure 1 , Figure 8 and Figure 11 As shown, an S100A9 sample sampling and detection device with a microneedle array includes a base 1, a limiting bar 4, and a fixing shell 7. Straps 8 are provided on both sides of the base 1. The limiting bar 4 is integrally formed on the top of the base 1 and distributed along the circumference of the top of the base 1. A working groove is formed between the limiting bar 4 and the base 1. In actual sampling and detection, the fixing shell 7 can be inserted into the working groove.

[0059] Combination Figure 8 and Figure 9 As shown, the fixing shell 7 has a T-shaped structure. The horizontal end of the fixing shell 7 is the handheld end, and the vertical end is the insertion end. The handheld end has symmetrical anti-slip textures on both sides. The top of the vertical plate of the fixing shell 7 has an observation groove, and the test strip 701 is placed inside the observation groove. At the same time, the surface of the fixing shell 7 is engraved with T and C markings (used to determine the approximate situation of S100A9 in the sample; the T marking is the detection line, and the C marking is the quality control line, used to determine the presence and concentration range of S100A9 in the sample). The bottom of the fixing shell 7 has a sample hole 702 located directly below the sample area of ​​the test strip 701. That is, when the sample liquid is dripped into the sample hole 702, it is absorbed by the test strip 701 and moves towards the C marking (it must pass through the T marking), thus forming the basic structure for convenient colorimetric detection of S100A9.

[0060] Combination Figure 2 , Figure 3 and Figure 4 As shown, a sampling groove 101 is opened at the top of the base 1, and a needle carrier plate 5 is slidably fitted inside the sampling groove 101. Several microneedles 501 are embedded in the bottom of the needle carrier plate 5, and then combined with... Figure 5As shown, the top of the needle carrier tray 5 has an integrally formed collecting tube 502 that communicates with the microneedle 501. A driving disc 503 is integrally formed on the outer surface of the top of the collecting tube 502. Furthermore, a positioning ring 6 is circumferentially fitted onto the outer surface of the needle carrier tray 5. Several buffer springs 601 are bonded to the top of the positioning ring 6, and these springs are distributed in a ring along the circumference of the positioning ring 6. The tops of all the buffer springs 601 are bonded to the needle carrier tray 5. The bottom of the positioning ring 6 is magnetically connected to the bottom wall of the sampling slot 101 (adsorption slot / magnetic block), allowing for quick installation of the needle carrier tray 5 into the sampling slot 101. It also allows for replacement of the needle carrier tray 5 and microneedle 501 after use, complying with medical safety standards.

[0061] To address the issue that conventional convenient test strips often contain interfering substances such as cell debris, hemoglobin, and non-specific proteins that affect test results, this solution is as follows:

[0062] Combination Figure 2 and Figure 6 As shown, a pretreatment disk 3 is also provided inside the sampling tank 101. The pretreatment disk 3 is slidably fitted with the inner wall of the sampling tank 101. A temporary storage cavity 304 is opened inside the pretreatment disk 3. A columnar liquid outlet 301 is attached to the top of the pretreatment disk 3. At the same time, a filtration channel 302 is opened on the inner wall of the pretreatment disk 3. The two ends of the filtration channel 302 are connected to the temporary storage cavity 304 and the liquid outlet 301, respectively. A filter membrane 303 is provided inside the filtration channel 302. The molecular weight cutoff of the filter membrane 303 is 30kDa to 50kDa. The driving disk 503 is located inside the temporary storage cavity 304 and is slidably fitted with the inner wall of the temporary storage cavity 304. The collecting tube 502 and the pretreatment disk 3 can rotate and slide. The pretreatment tray 3 has a threaded cylinder 305 integrally formed at its bottom end, which is threadedly connected to the top of the needle carrier tray 5 (i.e., the distance between the threaded cylinder 305 and the needle carrier tray 5 is adjustable). Both the threaded cylinder 305 and the temporary storage cavity 304 are located at the center of the pretreatment tray 3. Furthermore, when the pretreatment tray 3 is in its initial position (without the fixing shell 7 inserted), the top of the pretreatment tray 3 is positioned above the top of the base 1. When the fixing shell 7 is inserted, it can compress the pretreatment tray 3, causing the pretreatment tray 3 and the needle carrier tray 5 to move towards the positioning ring 6, thereby pushing out the microneedle 501, facilitating the microneedle 501's insertion into the patient's skin to collect samples. Secondly, even if the microneedle 501 contacts the patient's skin first when the fixing shell 7 is not inserted, the elasticity of the buffer spring 601 (i.e., the needle carrier tray 5 slides towards the pretreatment tray 3) allows the microneedle 501 to retract into the sampling slot 101, reducing the possibility of accidental contact.

[0063] Furthermore, since the filter membrane 303 is a molecular filter membrane 303, its filtration time is relatively long. Therefore, this solution specifically combines... Figure 9As shown, a guide groove is formed at the bottom of the fixed shell 7 along its length to mate with the liquid outlet 301. When the fixed shell 7 is inserted into the working slide groove, the liquid outlet 301 slides along the guide groove, and the sample hole 702 is located at one end of the guide groove. The guide groove is divided into four paths, starting from the sample hole 702: a first straight segment 703, a first arc segment 704, a second arc segment 705, and a second straight segment 706. The arc of the first arc segment 704 is greater than that of the second arc segment 705, and the curve formed by the first arc segment 704 and the second arc segment 705 is S-shaped. When the fixed shell 7 is inserted into the working slide groove, the liquid outlet 301 slides sequentially along the second straight segment 706, the second arc segment 705, the first arc segment 704, and the first straight segment 703, entering the sample hole 702.

[0064] When the outlet 301 slides along the second arc-shaped segment 705, the pretreatment disc 3 rotates clockwise (or counterclockwise) accordingly. Due to the threaded connection between the threaded cylinder 305 and the needle carrier disc 5, the pretreatment disc 3 can rise a certain distance. Simultaneously, to avoid physical interference during the rise of the pretreatment disc 3, such as... Figure 10 As shown, the thickness of the middle part of the fixed shell 7 along its length is less than the thickness of both ends of the fixed shell 7, and the first straight segment 703, the first arc segment 704, and the second arc segment 705 are all completely located within the middle part of the fixed shell 7, leaving a certain space for the pretreatment disk 3 to rise; secondly, as Figure 5 , Figure 6 and Figure 7 As shown, the top of the positioning ring 6 has a ring array of several buckles 602, and the surface of the needle carrier 5 has an annular groove 504 corresponding to the buckles 602. When the fixing shell 7 is inserted into the working slide groove (when the liquid outlet 301 slides along the second straight segment 706), the needle carrier 5 moves down, causing the buckles 602 to engage with the annular groove 504, locking the movement of the needle carrier 5. Thus, when the pretreatment plate 3 is completely in the area where the thickness of the fixing shell 7 is relatively low, it will not move directly upward due to the elasticity of the buffer spring 601, and will not press against the bottom of the fixing shell 7, providing a basis for the independent movement of the pretreatment plate 3 after the microneedle 501 pierces the skin. When the pretreatment plate 3 is raised, the volume inside the temporary storage cavity 304 increases, forming a certain negative pressure suction, which facilitates the rapid suction of the sample inside the microneedle 501 into the temporary storage cavity 304. At the same time, the collecting tube 502 is provided with a one-way valve, which allows the sample to flow from the collecting tube 502 to the temporary storage cavity 304, preventing sample backflow.

[0065] When the outlet 301 slides along the first arc segment 704, the pretreatment disk 3 rotates counterclockwise (or clockwise), that is, opposite to the initial rotation direction. The pretreatment disk 3 then descends a certain distance. At the same time, the curvature of the first arc segment 704 is greater than that of the second arc segment 705, so that the subsequent rotation angle of the pretreatment disk 3 is greater than the previous rotation angle. As a result, the descending distance will be greater than the ascending distance. That is, the distance between the driving disk 503 and the top of the temporary storage cavity 304 will decrease and be less than the initial spacing. This squeezes the liquid in the temporary storage cavity 304 toward the filter channel 302 and the filter layer, accelerating the filtration time. As the number of filtered samples increases, the filtered sample flows out of the outlet 301 along the filter channel 302 and enters the sample hole 702, where it is absorbed by the test paper 701.

[0066] Furthermore, the rotation direction of the pretreatment disc 3 is determined by the thread direction of the threaded cylinder 305, ensuring that the second arc segment 705 corresponds to the lifting of the pretreatment disc 3 and the first arc segment 704 corresponds to the lowering of the pretreatment disc 3. Additionally, symmetrical locking teeth are fixedly connected to both sides of the first straight segment 703 near the sample hole 702. These locking teeth restrict the liquid outlet 301 from sliding from the sample hole 702 towards the first straight segment 703. When the fixing shell 7 is withdrawn, the two locking teeth precisely lock the liquid outlet 301, forcing it to separate from the pretreatment disc 3. This effectively prevents the pretreatment disc 3 from rotating synchronously when the fixing shell 7 is withdrawn, thus avoiding the need to collect samples again via the microneedle 501, improving the stability and operational safety of the device.

[0067] The specific implementation process is as follows: First, the needle carrier plate 5 and the pretreatment plate 3 are quickly assembled into the sampling slot 101 by magnetically connecting the positioning ring 6 to the bottom wall of the sampling slot 101, ensuring that the buffer spring 601 is in a naturally extended state and that the buckle 602 is not engaged with the annular slot 504. The sampling slot 101 at the bottom of the base 1 is then placed against the patient's testing site (such as the inner side of the forearm), and then secured by the straps 8 on both sides of the base 1 to prevent the device from shifting during sampling and improve operational stability.

[0068] Holding the anti-slip textured end of the fixing shell 7, slowly push the insertion end of the fixing shell 7 into the working groove formed by the limiting bar 4 and the base 1. In the initial stage of insertion, the second straight section 706 of the bottom guide groove of the fixing shell 7 contacts the liquid outlet 301 of the pretreatment plate 3. The thicker area of ​​the fixing shell 7 at the inlet and outlet ends contacts the pretreatment plate 3 first, thereby pressing down the pretreatment plate 3, so that the needle carrier plate 5 and the microneedle 501 move down together with the pretreatment plate 3. The microneedle 501 moves out of the sampling groove 101, pierces the patient's skin, and collects blood samples. At the same time, the buckle 602 at the top of the positioning ring 6 is fully engaged with the annular groove 504 of the needle carrier plate 5, locking the position of the needle carrier plate 5 and ensuring that the microneedle 501 is stable and does not shake during the sampling process.

[0069] After the microneedle 501 pierces the skin, tissue fluid or blood samples flow into the collecting tube 502 through the capillary action of the microneedle 501. At this time, the outlet 301 slides into the second arc-shaped section 705, and the pretreatment disc 3 is fully inserted into the area with lower thickness of the fixing shell 7 (providing space for the subsequent lifting of the pretreatment disc 3), driving the pretreatment disc 3 to rotate clockwise. Due to the threaded connection between the threaded cylinder 305 and the needle carrier disc 5, the rotation is converted into the upward lifting of the pretreatment disc 3, the volume of the temporary storage chamber 304 increases, forming a negative pressure, which accelerates the rapid aspiration of the sample into the temporary storage chamber 304. At the same time, the one-way valve in the collecting tube 502 opens, and the sample flows into the temporary storage chamber 304 of the pretreatment disc 3 under the action of skin osmotic pressure and negative pressure in the temporary storage chamber 304. The one-way valve also blocks the sample backflow, avoiding contamination of the puncture site or the microneedle 501 channel.

[0070] As the fixed shell 7 is continuously inserted, the outlet 301 enters the first arc-shaped section 704 (with a larger arc compared to the second arc-shaped section 705). The pretreatment disk 3 rotates counterclockwise, and the rotation angle is greater than the rotation angle in the second arc-shaped section 705. This causes the pretreatment disk 3 to descend, reducing the distance between the driving disk 503 and the top of the temporary storage cavity 304 to less than the initial distance between the driving disk 503 and the top of the temporary storage cavity 304. This creates a squeezing pressure on the sample in the temporary storage cavity 304, causing the sample to flow rapidly into the filtration channel 302. The filtration membrane 303 in the filtration channel 302 has a molecular weight cutoff of 30kDa to 50kDa, which accurately intercepts large molecular interference substances such as cell debris and hemoglobin, but allows S100A9 (monomer 14kDa, dimer 28kDa) to pass through, thus achieving sample purification. The pressure makes the sample fully contact the filtration membrane 303, improving the filtration efficiency.

[0071] The fixing shell 7 is continuously pushed in until it reaches the outlet 301, where it slides along the first straight segment 703 to the sample well 702. The purified sample then flows out of the outlet 301 through the filter channel 302 and is precisely dripped into the sample well 702. It is quickly absorbed by the test strip 701 and migrates towards the C mark. During this process, it binds to the S100A9 specific antibody in the test strip, forming a color band. At this point, the presence and approximate concentration of S100A9 in the sample can be preliminarily determined by observing the color development of the T mark (detection line) and the C mark (control line) through the observation groove at the top of the fixing shell 7.

[0072] After the test is complete, the retaining shell 7 is pulled out in the reverse direction. When the outlet 301 slides towards the first straight segment 703, the locking teeth on both sides precisely lock the outlet 301, forcing the outlet 301 to separate from the pretreatment tray 3. This prevents the pretreatment tray 3 from rotating when the retaining shell 7 is pulled out, thus preventing the backflow or leakage of residual sample in the temporary storage chamber 304. Remove the strap 8, separate the base 1 from the skin, and use the magnetic separation positioning ring 6 to disassemble the needle tray 5 and the pretreatment tray 3 for disposal (in accordance with medical waste regulations). The base 1 can be cleaned and reused, improving the practicality and safety of the device.

[0073] Example 2:

[0074] As attached Figure 2 and Figure 8 As shown, the difference from Embodiment 1 is that the inner wall of the limiting rail 4 has three receiving grooves evenly distributed along the circumference, and each receiving groove has a positioning ball 401 slidingly fitted in it. Each positioning ball 401 is abutted against the bottom of the receiving groove by a return spring (in normal condition, the return spring is extended, causing the positioning ball 401 to protrude part of the inner wall of the limiting rail 4). The side wall of the insertion end of the fixing shell 7 has three positioning grooves that correspond one-to-one with the positioning ball 401.

[0075] When the fixed shell 7 is inserted into the working groove, the side wall of the fixed shell 7 first contacts the positioning ball 401 protruding from the inner wall of the limiting rail 4. As the insertion force is applied, the positioning ball 401 is squeezed and retracts into the receiving groove. The reset spring is simultaneously compressed and accumulates elastic potential energy. When the fixed shell 7 is pushed to the preset position (the liquid outlet 301 is exactly aligned with the sample hole 702), the positioning groove moves to the front of the positioning ball 401. The elastic potential energy of the reset spring is released, pushing the positioning ball 401 to pop out and lock into the corresponding positioning groove. The three circumferentially evenly distributed positioning balls 401 form a triangular positioning structure, which can apply clamping force to the fixed shell 7 from multiple directions, so that the fixed shell 7 is accurately fixed in the working groove. This reduces problems such as the liquid outlet 301 deviating from the sample hole 702, sample dripping, or poor contact of the test paper 701 caused by device shaking or displacement during the detection process.

[0076] Example 3:

[0077] As attached Figure 1 As shown, the difference from Embodiment 2 is that an integrated monitoring panel 2 is embedded in the surface of the base 1, the positioning balls 401 are all made of metal (such as copper alloy), the tail of the positioning ball 401 is connected to the internal circuit of the monitoring panel 2 through a wire, the inner wall of the positioning groove is provided with a metal layer, the test paper 701 is embedded with an electrode assembly, the electrode assembly includes a working electrode, a reference electrode and a counter electrode, the working electrode, the reference electrode and the counter electrode are electrically connected to the metal layer respectively; the monitoring panel 2 has a built-in S100A9 monitoring system.

[0078] The S100A9 monitoring system includes: a signal acquisition module, a preprocessing module, an analysis and calibration module, an output module, and a monitoring module;

[0079] The signal acquisition module is used to acquire the electrical signal after the S100A9 is combined with the working electrode;

[0080] The preprocessing module is used to reduce noise, amplify, and convert the original electrical signal to generate digital signal data;

[0081] The analysis and calibration module is used to preset the calibration curve database of S100A9 concentration-signal intensity; it matches digital signal data with the calibration curve database to calculate the actual concentration of S100A9 in the sample; it can also automatically correct the curve parameters based on the data of blank samples and standard samples in the calibration curve database.

[0082] The output module is used to display the concentration results and qualitative conclusions of the analysis and calibration module in real time on the monitoring panel 2;

[0083] The monitoring module records the user's daily S100A9 concentration data by timestamp, establishing a personal testing database; it automatically integrates weekly S100A9 concentration data to form a trend curve, and uploads weekly S100A9 concentration change data, outlier records, and trend analysis results to the terminal server via wireless transmission technology; at the same time, it can mark and push early warning prompts for concentration data that is continuously high or changes abruptly within a week according to preset safety thresholds.

[0084] The collaborative operation mechanism of each module of the S100A9 monitoring system is as follows:

[0085] When the positioning ball 401 is inserted into the positioning groove to form mechanical positioning, the metal positioning ball 401 is in close contact with the metal layer of the positioning groove, simultaneously establishing a conductive path between each electrode and the monitoring panel 2. After the test paper 701 adsorbs the sample, S100A9 binds to the specific recognition probe on the surface of the working electrode, triggering an electrochemical signal (such as changes in current and potential) on the electrode surface. The signal acquisition module captures this raw electrical signal in real time and transmits it to the preprocessing module. After filtering out environmental noise and amplifying the weak signal by an operational amplifier, the analog signal is converted into digital signal data. The analysis and calibration module calls the preset S100A9 concentration-signal intensity calibration curve database (containing multi-gradient standard calibration data), matches the digital signal data with the calibration curve, and calculates the actual concentration value of S100A9 in the sample. At the same time, it relies on the baseline data of the blank sample and the standard quality control data. According to the system, the automatic correction curve offset parameters eliminate detection errors caused by batch differences in test strips and temperature fluctuations. The output module displays the quantitative concentration results and qualitative conclusions (such as "normal / abnormal") in real time on the LCD interface of monitoring panel 2 for easy reading. The monitoring module automatically records the concentration data of each test according to the timestamp, builds a personalized test database, integrates the data weekly to generate a dynamic trend curve (intuitively presenting the concentration change pattern), and uploads the concentration fluctuation data, abnormal values ​​(such as records exceeding the safety threshold), and trend analysis reports within a week to the terminal server (such as a hospital management system or a personal health APP) via Bluetooth / Wi-Fi wireless transmission technology. When the concentration is detected to be consistently high or to change abruptly within a week, the system automatically marks the abnormal data and pushes an early warning (audio and visual reminders on monitoring panel 2 + terminal message push), promptly warning of potential health risks.

[0086] Obviously, the above embodiments are merely illustrative examples for clear explanation and are not intended to limit the implementation. Those skilled in the art will recognize that other variations or modifications can be made based on the above description. It is neither necessary nor possible to exhaustively list all possible implementations here. However, obvious variations or modifications derived therefrom are still within the scope of protection of this invention.

Claims

1. An S100A9 sample sampling and detection device containing a microneedle array, characterized in that, Includes a base (1), a limiting bar (4), and a colorimetric component for detecting the concentration of S100A9 in a sample. The limiting bar (4) is fixedly connected to the top of the base (1) and distributed along the circumference of the top of the base (1). A working groove for inserting the colorimetric component is formed between the limiting bar (4) and the base (1). The top of the base (1) is provided with a sampling slot (101). A microneedle assembly for piercing the patient's skin to take a sample is fixedly connected to the bottom wall of the sampling slot (101). The top of the microneedle assembly is connected to a pretreatment assembly for filtering the extracted sample. The pretreatment assembly is located in the sampling slot (101) and the pretreatment assembly and the microneedle assembly are rotatably connected. As the colorimetric component is inserted into the working chute, it provides driving force to the pretreatment component, allowing the filtered sample to be input into the colorimetric component for detection.

2. The S100A9 sample sampling and detection device with microneedle array according to claim 1, characterized in that, The microneedle assembly includes a needle carrier plate (5) and a number of microneedles (501). The microneedles (501) are all located at the bottom of the needle carrier plate (5). The top of the needle carrier plate (5) is provided with a collection tube (502) that communicates with the microneedles (501). A drive disc (503) is fixedly connected to the outer surface of the top of the collection tube (502). An elastic component is wrapped around the outer surface of the needle carrier plate (5) to buffer the needle carrier plate (5) when it slides along the central axis of the sampling groove (101).

3. The S100A9 sample sampling and detection device with microneedle array according to claim 2, characterized in that, The elastic component includes a positioning ring (6) and several buffer springs (601). The positioning ring (6) is detachably connected to the bottom wall of the sampling groove (101). The bottom ends of the buffer springs (601) are all fixedly connected to the top end of the positioning ring (6) and are distributed in a ring array. The top ends of the buffer springs (601) are all fixedly connected to the needle carrier plate (5).

4. The S100A9 sample sampling and detection device with microneedle array according to claim 3, characterized in that, The top of the positioning ring (6) has a ring array of several buckles (602), and the surface of the needle carrier (5) has a ring groove (504) corresponding to the buckles (602).

5. The S100A9 sample sampling and detection device with microneedle array according to claim 4, characterized in that, The pretreatment component includes a pretreatment tray (3), which has a storage chamber (304) inside. A columnar liquid outlet (301) is fixedly connected to the top of the pretreatment tray (3). A filter channel (302) is provided inside the pretreatment tray (3), and the two ends of the filter channel (302) are connected to the storage chamber (304) and the liquid outlet (301) respectively. The drive disc (503) is located in the temporary storage cavity (304) and slides in cooperation with the inner wall of the temporary storage cavity (304); the bottom end of the pretreatment disc (3) is fixedly connected to a threaded cylinder (305), and the threaded cylinder (305) is threadedly connected to the top end of the needle carrier disc (5); the threaded cylinder (305) and the temporary storage cavity (304) are both located at the center of the pretreatment disc (3); when the pretreatment disc (3) is in the initial position, the top end of the pretreatment disc (3) is located above the top end of the base (1); A filter membrane (303) is provided inside the filter channel (302), and the molecular weight cutoff of the filter membrane (303) is 30kDa to 50kDa.

6. The S100A9 sample sampling and detection device with microneedle array according to claim 5, characterized in that, The collecting tube (502) is provided with a one-way lobe, which allows the sample to flow from the collecting tube (502) to the temporary storage chamber (304).

7. The S100A9 sample sampling and detection device with microneedle array according to claim 6, characterized in that, The color development component includes a T-shaped fixed shell (7), with an observation groove at the top of the fixed shell (7), and a test strip (701) for detecting S100A9 is placed inside the observation groove. A guide groove is opened at the bottom of the fixed shell (7) along the length direction of the fixed shell (7), and a sample hole (702) is opened at the bottom of the fixed shell (7) directly below the sample area of ​​the test strip (701), and the sample hole (702) is located at one end of the guide groove. The guide groove is divided into four paths, starting from the sample hole (702): the first straight section (703), the first arc section (704), the second arc section (705), and the second straight section (706). The arc of the first arc section (704) is greater than that of the second arc section (705), and the bending direction of the first arc section (704) is opposite to that of the second arc section (705). The thickness of the middle part of the fixed shell (7) along the length direction is less than the thickness of the two ends of the fixed shell (7), and the first straight segment (703), the first arc segment (704) and the second arc segment (705) are all completely inside the middle part of the fixed shell (7); When the fixed shell (7) is inserted into the working groove, the liquid outlet (301) slides along the second straight section (706), the second arc section (705), the first arc section (704) and the first straight section (703) in sequence, and enters the sample hole (702).

8. The S100A9 sample sampling and detection device with microneedle array according to claim 7, characterized in that, The first straight section (703) has symmetrical fixed connections on both sides of the two walls with locking teeth near the sample hole (702). The locking teeth are used to restrict the liquid outlet (301) from sliding from the sample hole (702) to the first straight section (703). The positioning ring (6) is magnetically connected to the bottom wall of the sampling groove (101).

9. The S100A9 sample sampling and detection device with microneedle array according to claim 8, characterized in that, The inner wall of the limiting bar (4) is evenly distributed with several receiving grooves along the circumference. Each receiving groove is slidably fitted with a positioning ball (401), and each positioning ball (401) is abutted against the bottom of the receiving groove by a return spring. The side wall of the insertion end of the fixed shell (7) is provided with several positioning grooves that correspond one-to-one with the positioning balls (401).

10. The S100A9 sample sampling and detection device with microneedle array according to claim 9, characterized in that, The base (1) is provided with a monitoring panel (2), the positioning balls (401) are all made of metal, and the positioning balls (401) are all electrically connected to the monitoring panel (2). The inner wall of the positioning groove is provided with a metal layer. The test paper (701) is embedded with an electrode assembly, which includes a working electrode, a reference electrode and a counter electrode. The working electrode, the reference electrode and the counter electrode are electrically connected to the metal layer respectively. The monitoring panel (2) is equipped with an S100A9 monitoring system. The S100A9 monitoring system includes: a signal acquisition module, a preprocessing module, an analysis and calibration module, an output module, and a monitoring module; The signal acquisition module is used to acquire the electrical signal after the S100A9 is combined with the working electrode; The preprocessing module is used to reduce noise, amplify, and convert the original electrical signal to generate digital signal data; The analysis and calibration module is used to preset the calibration curve database of S100A9 concentration-signal intensity; it matches digital signal data with the calibration curve database to calculate the actual concentration of S100A9 in the sample; it can also automatically correct the curve parameters based on the data of blank samples and standard samples in the calibration curve database. The output module is used to display the concentration results and qualitative conclusions after analysis by the analysis and calibration module in real time on the monitoring panel (2); The monitoring module records the user's daily S100A9 concentration data by timestamp, establishing a personal testing database; it automatically integrates weekly S100A9 concentration data to form a trend curve, and uploads weekly S100A9 concentration change data, outlier records, and trend analysis results to the terminal server via wireless transmission technology; at the same time, it can mark and push early warning prompts for concentration data that is continuously high or changes abruptly within a week according to preset safety thresholds.

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