Electronic acupuncture needle and manufacturing method thereof

Abstract

The invention provides an electronic acupuncture needle and a manufacturing method thereof, and the electronic acupuncture needle comprises a needle body which is provided with a needle point part and a handle part; the flexible sensing area is wound and attached to the surface of the needle point part in a spiral form through a first connecting structure; and the signal processing area is electrically connected with the flexible sensing area through a wire. By means of collaborative design of the needle body, the flexible sensing area and the signal processing area, on the basis that the traditional acupuncture operation hand feeling and safety are reserved, high-precision and in-situ real-time detection of various biomarkers is achieved, adaptability is high, operation is flexible, cost is controllable, and high clinical practical value is achieved.

Description

Technical Field

[0001] This disclosure relates to the field of biosensing technology, specifically to electronic acupuncture needles and their manufacturing methods. Background Technology

[0002] With the acceleration of precision medicine and the modernization of traditional Chinese medicine diagnosis and treatment, the need for real-time, in-situ monitoring of the physiological and biochemical state of local tissues during acupuncture treatment is becoming increasingly prominent. Although traditional acupuncture needles, as meridian stimulation tools, can directly enter human tissues, their function is limited to mechanical stimulation and neural regulation. They cannot simultaneously obtain dynamic information on key biomarkers such as ion concentration, metabolites, and inflammatory factors during treatment, thus limiting the objective evaluation and personalized control of acupuncture efficacy.

[0003] Currently, several technologies have attempted to integrate sensing functions with acupuncture needles, primarily including the following approaches: First, attaching an independent sensing probe externally to the needle or using the needle itself as a single electrochemical electrode. While this approach achieves partial electrochemical detection, it is bulky, complex to operate, significantly alters the shape and feel of the acupuncture needle, and makes simultaneous detection of multiple indicators difficult. Second, integrating a sensing coating or thin-film device with fixed functions onto the needle surface using microfabrication technology. While this achieves a degree of miniaturized integration of detection functions with the needle, the sensing function is fixed once fabricated, making it impossible to flexibly switch detection indicators according to clinical needs, resulting in high operating costs and cumbersome clinical preparation. Third, attaching the sensing unit to the needle using flexible electronic technology. However, existing attachment methods often employ axial flat laying or point fixation, failing to fully consider the slender cylindrical structure of the acupuncture needle and the mechanical environment during insertion. This can easily lead to warping, cracking, or detachment of the sensing layer from the needle during use due to poor adhesion and stress concentration, affecting detection reliability.

[0004] Therefore, how to develop an electronic acupuncture needle that can stably and reliably perform in-situ detection of multiple indicators and flexibly adapt to different detection needs without significantly altering the clinical operation experience and structural morphology of acupuncture needles has become a key technical problem that urgently needs to be solved in the intersection of the modernization of traditional Chinese medicine instruments and biosensing. Summary of the Invention

[0005] This disclosure presents an electronic acupuncture needle and a method for manufacturing the same.

[0006] In a first aspect, this disclosure provides an electronic acupuncture needle, comprising: a needle body having a needle tip and a handle; a flexible sensing region, which is spirally wound and attached to the surface of the needle tip via a first connecting structure, the flexible sensing region including at least one field-effect transistor sensing unit; and a signal processing region electrically connected to the flexible sensing region via a wire; wherein the gate of the field-effect transistor sensing unit is coupled to the body fluid at the needle tip via a functional layer covering the surface to form a liquid gate.

[0007] In some alternative implementations, the first connection structure is a peelable adhesive layer.

[0008] In some alternative embodiments, a reference electrode material layer is provided on the surface of the needle tip.

[0009] In some alternative implementations, the flexible sensing region includes a flexible substrate on which the field-effect transistor sensing unit is disposed.

[0010] In some alternative implementations, the functional layer is detachably covered on the gate surface of the field-effect transistor sensing unit via a second connection structure; Preferably, the functional layer includes an identification layer, a current limiting layer, and a protection layer stacked sequentially from bottom to top.

[0011] In some alternative implementations, the second connection structure is a pluggable snap-fit ​​structure or an adsorbable magnetic structure.

[0012] Secondly, this disclosure provides a method for manufacturing an electronic acupuncture needle, the method comprising: providing a needle body having a needle tip and a handle; preparing a flexible sensing region including at least one field-effect transistor sensing unit; winding the flexible sensing region in a spiral shape and attaching it to the surface of the needle tip through a first connection structure, wherein the gate of the field-effect transistor sensing unit is coupled to the body fluid through a functional layer to form a liquid gate; and electrically connecting the flexible sensing region to a signal processing region through a wire.

[0013] In some alternative embodiments, before the flexible sensing region is wound in a spiral shape and attached to the surface of the needle tip through the first connection structure, the method further includes coating the surface of the needle tip with a reference electrode material layer.

[0014] In some alternative implementations, the method further includes: detachably mounting the functional layer to the gate surface of the field-effect transistor sensing unit via a second connection structure.

[0015] In some alternative implementations, the method further includes replacing the functional layer mounted on the gate surface by manipulating the second connection structure.

[0016] To address the problems of existing electronic acupuncture needles in clinical applications, such as limited detection functions, non-replaceable sensing structures, poor adaptability to the in vivo environment, and significant signal drift, and to overcome the shortcomings of traditional sensing needles, including high manufacturing costs, cumbersome clinical preparation, and the need for repeated punctures for multi-index detection, this disclosure proposes an electronic acupuncture needle and its manufacturing method. This electronic acupuncture needle, through the collaborative design of the needle body, flexible sensing area, and signal processing area, achieves high-precision, in-situ, real-time detection of multiple biomarkers while retaining the feel and safety of traditional acupuncture operation. It is highly adaptable, flexible in operation, and cost-effective, possessing significant clinical practical value. Attached Figure Description

[0017] Other features, objects, and advantages of this disclosure will become more apparent from the following detailed description of non-limiting embodiments with reference to the accompanying drawings: Figure 1 This is a schematic diagram of the structure of an electronic acupuncture needle according to an embodiment of the present disclosure; Figure 2 This is a schematic diagram of the structure of the flexible sensing region in this disclosure; Figure 3 This is a schematic diagram showing the connection relationship between the flexible sensing area and the signal processing area in this disclosure.

[0018] Explanation of reference numerals / symbols in the attached diagram: 100-Electronic acupuncture needle; 101-Needle tip; 1011-Reference electrode material layer; 102-Handle; 20-Flexible sensing area; 201-Field effect transistor sensing unit; 202-Flexible substrate; 30-Signal processing area; 301-Wire. Detailed Implementation

[0019] The specific embodiments of this disclosure are described below with reference to the accompanying drawings and examples. Through the content described in this specification, those skilled in the art can clearly and completely understand the technical solutions, the technical problems solved, and the resulting technical effects of this disclosure. It is understood that the specific embodiments described herein are only for explaining this disclosure and not for limiting it. Furthermore, for ease of description, only the parts related to this disclosure are shown in the accompanying drawings.

[0020] It should be noted that the structures, proportions, sizes, etc., shown in the accompanying drawings are only for the purpose of assisting those skilled in the art in understanding and reading the contents described in the specification, and are not intended to limit the conditions under which this disclosure can be implemented. Therefore, they have no substantial technical significance. Any modifications to the structure, changes in the proportions, or adjustments to the size should fall within the scope of the technical content disclosed in this disclosure, provided that they do not affect the effects and purposes that this disclosure can produce.

[0021] The use of terms such as "first," "second," and "the" does not imply quantity limitation and may indicate singular or plural. The terms "comprising," "including," "having," and any variations thereof used in this disclosure are intended to cover non-exclusive inclusion; for example, a process, method, system, product, or apparatus that includes a series of steps or modules is not limited to the listed steps or areas, but may also include steps or areas not listed, or other steps or areas inherent to such processes, methods, products, or apparatus. The terms "connection," "accommodation," and "perforation" used in this disclosure are not limited to physical or mechanical connections, but may also include direct or indirect electrical connections.

[0022] refer to Figures 1 to 3 , Figure 1 This is a schematic diagram of the structure of an embodiment of the electronic acupuncture needle 100 according to the present disclosure. Figure 2 This is a schematic diagram of the structure of the flexible sensing region 20 in this disclosure. Figure 3 This is a schematic diagram showing the connection relationship between the flexible sensing area 20 and the signal processing area 30 in this disclosure.

[0023] like Figure 1 , Figure 2 and Figure 3 As shown, the electronic acupuncture needle 100 may include: a needle body ( Figure 1 (Not shown in the image), flexible sensing area 20 and signal processing area 30. Wherein: Here, the needle body has a needle tip 101 for inserting into biological tissue and a handle 102 for easy gripping and operation.

[0024] The flexible sensing area 20 is spirally wound and attached to the surface of the needle tip 101 via a first connecting structure (e.g., a layer of biocompatible adhesive). This spiral attachment method allows the flexible sensing area 20 to tightly cover the curved surface in a wrinkle-free and low-stress state, ensuring a stable interface adhesion. Secondly, the spiral path maximizes the extension of the sensing area on the limited needle surface, significantly increasing the effective contact area with body fluids to improve the intensity and sensitivity of the detection signal. In addition, the spiral attachment shape has uniform thickness and a streamlined wrapping shape, which basically does not increase the outer diameter of the needle or affect its puncture mechanical properties. It can maintain structural integrity with the slight deformation of the needle during the needle insertion operation, ensuring the continuity of the sensing function during the treatment process.

[0025] The flexible sensing region 20 integrates at least one field-effect transistor (FET) sensing unit 201. The FET sensing unit 201 is a micro / nano sensor based on the electrical properties of semiconductors, comprising a source, drain, gate, and semiconductor channel. The gate, through a surface-modified functional layer, directly contacts the body fluid at the needle tip. The body fluid acts as the gate medium. When the concentration of the target substance (such as specific ions, glucose, neurotransmitters, etc.) in the body fluid changes, it causes a change in the potential at the gate / electrolyte interface, thereby modulating the conductivity of the semiconductor channel, manifested as a measurable change in the source-drain current. Preferably, the semiconductor channel material can be silicon, metal oxides (such as zirconium tin oxide), or organic semiconductors, to meet the requirements of different detection targets and sensitivities.

[0026] In practical implementation, the functional layer covering the gate surface can be customized according to different detection targets. For example, it can be modified to a selective ion membrane to detect specific ions such as hydrogen ions and potassium ions, or to immobilize glucose oxidase to detect glucose. During use, users or medical personnel can easily replace different functional layer modules using simple mechanical structures (such as pluggable snap-fit ​​structures or magnetic adsorption structures), allowing the same electronic acupuncture needle to flexibly and quickly switch between different detection tasks, thereby achieving specific and highly sensitive identification of multiple targets.

[0027] The gate of the field-effect transistor sensing unit 201 is coupled to the body fluid (such as interstitial fluid) at the needle tip 101 through a functional layer covering its surface, forming a liquid gate coupling. The body fluid directly serves as the gate dielectric of the field-effect transistor sensing unit 201, and the interface between the functional layer and the body fluid constitutes the sensing interface. When the ion concentration or specific biomolecules in the body fluid change, the potential of the sensing interface changes, thereby modulating the channel current of the field-effect transistor sensing unit 201 and generating a detectable change in electrical signal, thus achieving highly sensitive, real-time, in-situ detection of physiological or biochemical parameters.

[0028] The signal processing area 30 is electrically connected to the flexible sensing area 20 via a wire 301, and is used to receive, amplify, and process sensing signals. Preferably, the signal processing area 30 can be located in an external device. When the signal processing area 30 is located in an external device, it receives the raw electrical signals from the flexible sensing area 20 via the wire 301. During acupuncture, these raw electrical signals are transmitted in real time to the external signal processing area 30 via the wire 301. The signal processing area 30 has a built-in high-precision, low-noise preamplifier circuit to perform primary amplification of the raw electrical signals. Then, a programmable gain amplifier and an adaptive filtering module are used to eliminate bioelectrical interference and environmental noise. The electrical signals are then digitized by a high-resolution analog-to-digital converter to form digital signals. The processed digital signals are then interpreted by a dedicated algorithm to map voltage / current changes to specific physiological and biochemical parameter concentration values. Finally, the visualized data and analysis results are presented to the operator in real time via a display screen or wireless network.

[0029] By spirally attaching the flexible sensing region 20 to the surface of the needle tip 101, a tight and stable fit between the flexible sensing region 20 and the curved surface of the needle body is ensured, and the contact area between the sensing interface and the body fluid is significantly increased, thereby improving the intensity and stability of the detection signal. By covering the gate surface of the field-effect transistor sensing unit with a customizable functional layer and forming a liquid gate coupling with the body fluid, changes in the concentration of ions or biomolecules in the body fluid can directly modulate the channel current, thereby achieving highly sensitive, real-time, in-situ detection of a variety of physiological and biochemical parameters.

[0030] In some alternative implementations, the first connection structure is a peelable adhesive layer.

[0031] Here, the first connecting structure can be made of medical adhesive or hydrogel with good biocompatibility, flexibility, and adhesion. The peelable design allows the flexible sensing area 20 to be removed from the needle tip 101 after a single use or when replacement is needed, facilitating needle disinfection and reuse.

[0032] By using a peelable adhesive layer as the first connection structure, the cost of using electronic acupuncture needles is reduced and the flexibility of replacing the flexible sensing area 20 is improved.

[0033] In some alternative embodiments, a reference electrode material layer 1011 may be provided on the surface of the needle tip 101.

[0034] Here, the reference electrode material layer 1011 may contain silver / silver chloride electrode material. When the needle itself is a silver needle, a stable silver chloride layer can be directly formed on its tip 101 by electrochemical or physical methods; when the needle is not made of silver, a silver layer needs to be plated on the surface of the tip 101 first, and then a silver chloride layer is formed on the silver layer, thereby constituting the reference electrode material layer 1011 of the silver / silver chloride electrode pair structure.

[0035] By setting a reference electrode material layer 1011, a stable electrochemical potential benchmark can be established in the body fluid environment, thereby significantly improving the stability and accuracy of the detection signal.

[0036] In some alternative implementations, the flexible sensing region 20 may include a flexible substrate 202, and the field-effect transistor sensing unit 201 may be disposed on the flexible substrate 202.

[0037] Here, the flexible substrate 202 serves as the underlying structure for carrying and supporting the field-effect transistor sensing unit 201. It can be made of a polymer with excellent biocompatibility, flexibility, and insulating properties, such as polyimide, polyethylene terephthalate, or polydimethylsiloxane. The field-effect transistor sensing unit 201 is integrated onto the flexible substrate 202 using micro-nano technology, enabling simultaneous contact with body fluids from multiple angles after the needle tip 101 pierces human tissue. This facilitates the acquisition of a more spatially uniform sensing signal, improving the comprehensiveness and reliability of the detection.

[0038] By setting a flexible substrate, a flat and stable working surface is provided for the field-effect transistor sensing unit 201, and the field-effect transistor sensing unit 201 as a whole adapts to the curved shape of the needle tip 101 surface, ensuring that no brittleness or detachment occurs during the wrapping and application of the needle.

[0039] In some alternative implementations, the functional layer can be detachably covered on the gate surface of the field-effect transistor sensing unit 201 via a second connection structure.

[0040] Optionally, the functional layer may include an identification layer, a current limiting layer, and a protection layer stacked sequentially from bottom to top.

[0041] Here, the second connection structure refers to a mechanical or physical coupling device that enables repeated installation and removal between the functional layer and the gate surface. This second connection structure allows users to quickly replace functional layer modules with different recognition characteristics according to different detection needs without damaging the gate surface. This enables flexible detection of multiple targets using the same electronic acupuncture device, significantly improving the reusability and application range of the equipment.

[0042] In practical implementation, the recognition layer is a functionalized film layer directly facing the gate surface. The material of the recognition layer is selected according to the specificity of the detection target, such as using a hydrogen ion sensitive membrane, a potassium ion selective membrane, or a polymer immobilized with biorecognition elements such as glucose oxidase or antibodies, to specifically capture target substances in body fluids and generate corresponding interfacial potential changes. The current-limiting layer is located above the recognition layer and is usually composed of porous materials with molecular sieving properties. It is used to control the transport rate of target substances and interfering substances, improve the selectivity of detection, and protect the recognition layer. The protective layer, as the outermost layer, is formed of biocompatible hydrogels or porous polymer materials (such as polyvinyl alcohol or agarose). It is in direct contact with body fluids and is used to physically isolate biological contaminants, reduce tissue reactions, and maintain a stable liquid-solid interface environment.

[0043] In some alternative implementations, the second connection structure may be a pluggable snap-fit ​​structure or an adsorbable magnetic structure.

[0044] In specific implementations, when the second connection structure adopts a pluggable snap-fit ​​structure, a micro-slot can be set around the gate region of the field-effect transistor sensing unit 201, and matching tenons can be formed on the corresponding edges of the functional layer. By applying light pressure, the tenons can be inserted into the slot to complete the fixation, and by applying reverse force, separation can be achieved. When the second connection structure adopts an adsorption-compatible magnetic structure, micro-magnets or magnetic thin layers can be embedded on the gate surface and the back of the functional layer, respectively. The attraction between the magnets allows the functional layer to automatically align and tightly adhere to the gate surface. When replacing, it is only necessary to overcome the magnetic force to peel it off.

[0045] By setting the second connection structure as a pluggable snap-on structure or an adsorbable magnetic structure, users can quickly and accurately install and replace the functional layer on the spot without the need for special tools, which greatly improves the switching efficiency and ease of use of electronic acupuncture needles between different detection tasks.

[0046] This disclosure provides a method for manufacturing an electronic acupuncture needle 100, the method comprising: The first step is to provide the needle body. Here, the needle body may have a needle tip 101 and a shank 102.

[0047] The second step is to fabricate the flexible sensing region 20. Here, the flexible sensing region 20 may include at least one field-effect transistor sensing unit 201.

[0048] It is understandable that the needle body can be provided first, and then the flexible sensing area 20 can be fabricated. Alternatively, the flexible sensing area 20 can be fabricated first, and then the needle body can be provided.

[0049] Next, the flexible sensing region 20 is wound in a spiral shape and attached to the surface of the needle tip 101 through the first connection structure. The gate of the field effect transistor sensing unit 201 is coupled to the body fluid through the functional layer to form a liquid gate.

[0050] Finally, the flexible sensing area 20 is electrically connected to the signal processing area 30 via wire 301.

[0051] Specifically, when preparing the flexible sensing region 20, a flexible substrate material with excellent flexibility and biocompatibility (such as a polyimide film) can be selected first. After cleaning and surface activation treatment, the following micro-nano processing steps are sequentially performed on the surface of the flexible substrate 202: 1. The source and drain are patterned using photolithography. Metal electrode layers (such as gold, platinum, or titanium / gold stacks) are formed by physical vapor deposition or electrochemical deposition. Then, the source and drain are precisely patterned by lift-off or etching processes.

[0052] 2. In the channel region between the source and drain electrodes, a semiconductor active layer (e.g., zinc oxide, organic semiconductor, or two-dimensional material) is formed by chemical vapor deposition, solution spin coating, or printing processes.

[0053] 3. A gate insulating layer is formed above the channel region through dielectric layer deposition and patterning processes, and a gate metal structure is fabricated, thereby completing the entire device construction of the field-effect transistor sensing unit.

[0054] 4. After the gate structure is completed, modular assembly is selected on the gate surface according to the detection requirements: First, a functional layer containing specific recognition characteristics is prefabricated on an independent substrate, and then the functional layer is installed to the gate region with the help of a second connection structure.

[0055] 5. Using laser precision cutting or die-cutting technology, the thin film integrating multiple field-effect transistor sensing units 201 on the wafer scale is cut into a spiral strip structure of a preset width to form an independently operable flexible sensing area 20.

[0056] In specific implementation, during the process of the gate of the field-effect transistor sensing unit 201 forming a liquid gate coupling with the body fluid through the functional layer, the functional layer is first constructed on the gate metal surface that has undergone micro-nano fabrication, and the functional layer is directly exposed to the sensing interface. When the needle tip 101 pierces the biological tissue, the body fluid (such as interstitial fluid) wets and contacts the outer surface of the functional layer, at which point a stable liquid-solid interface is formed between the functional layer and the body fluid. As an ion-conducting medium, the body fluid forms an electrochemical double layer at the interface with the functional layer. This electrochemical double layer is electrically coupled to the gate through the functional layer, thereby allowing the gate potential to be directly controlled by the interfacial electrochemical potential. When the concentration of target ions or molecules in the body fluid changes, it causes a corresponding change in the interfacial potential. This change is transmitted to the gate through coupling, thereby modulating the channel current, ultimately realizing the liquid gate coupling sensing mechanism that converts the biochemical signal of the body fluid into a detectable electrical signal.

[0057] In some alternative embodiments, before the flexible sensing region 20 is wound in a spiral shape and attached to the surface of the needle tip 101 through the first connection structure, the method further includes coating the surface of the needle tip 101 with a reference electrode material layer 1011.

[0058] Here, when coating the reference electrode material layer, the surface of the needle tip 101 is first cleaned and activated to improve the adhesion of the subsequent coating. If the needle tip 101 itself is made of silver, surface oxidation or chlorination is performed directly on the needle tip 101 to form a stable silver chloride layer. If the needle tip 101 is not made of silver, electrochemical deposition, physical vapor deposition, or micro-area dot coating processes are first used to form a uniform silver layer in a designated area on the surface of the needle tip 101. Then, through electrochemical oxidation or chlorination, the surface of the silver layer is partially converted into silver chloride, thereby forming a stable silver / silver chloride electrode pair structure. Finally, the formed reference electrode material layer 1011 is cleaned and stabilized to ensure that the reference electrode material layer 1011 has long-term stable electrochemical potential reference performance in a body fluid environment.

[0059] By coating the surface of the needle tip with a reference electrode material layer, the stability and accuracy of the detection signal are significantly improved.

[0060] In some alternative implementations, the method further includes: detachably mounting the functional layer to the gate surface of the field-effect transistor sensing unit 201 via a second connection structure.

[0061] When installing the functional layer, if a pluggable snap-fit ​​structure is used, align the micro-snapsticks pre-made on the edge of the functional layer with the corresponding slots around the gate area and apply light pressure until the snapsticks are fully embedded in the slots, thus completing the installation; if an adsorption-type magnetic structure is used, bring the back of the functional layer with embedded magnetic material close to the corresponding magnet or magnetic conductive layer pre-made on the gate surface, and use magnetic force to automatically align and fit it tightly.

[0062] By detachably mounting the functional layer to the gate surface of the field-effect transistor sensing unit through the second connection structure, users can quickly switch the functional layer according to different detection needs. This enables flexible adaptation to the detection of various targets without replacing the needle body and flexible sensing area, significantly improving the reusability, detection efficiency and cost-effectiveness of electronic acupuncture needles.

[0063] In some alternative implementations, the method further includes replacing the functional layer mounted on the gate surface by manipulating the second connection structure.

[0064] Here, during the specific replacement, if the second connection structure is a pluggable snap-fit ​​structure, apply a slight pulling force opposite to the installation direction to the edge of the functional layer to disengage the snap-fit ​​from the slot, thus removing the old functional layer; then align the snap-fit ​​of the new functional layer with the slot and re-press and fix it according to the installation steps. If the second connection structure is an adsorption-type magnetic structure, directly overcome the magnetic attraction to peel the old functional layer off the gate surface, and then bring the new functional layer close to the gate surface so that it automatically adsorbs, aligns, and adheres under the action of magnetic force.

[0065] By operating the second connection structure and replacing the functional layer mounted on the gate surface, a single electronic acupuncture needle can flexibly adapt to the detection needs of different targets by quickly replacing the functional layer module, without having to replace the entire needle body or sensing unit, thereby significantly improving the reusability of the device and facilitating the maintenance of the electronic acupuncture needle.

[0066] Although this disclosure has been described and illustrated with reference to specific embodiments thereof, such descriptions and illustrations are not intended to limit this disclosure. It will be readily understood by those skilled in the art that various changes can be made and equivalent elements can be substituted within embodiments without departing from the scope of protection of this disclosure as defined by the claims. Differences may exist between the technical representation in this disclosure and actual devices due to variables in the manufacturing process, etc. Other embodiments of this disclosure may exist that are not specifically described. The description and illustrations should be considered illustrative rather than restrictive, and modifications can be made to suit the purpose and spirit of this disclosure, all of which are within the scope of the claims. While the methods disclosed herein have been described with reference to specific operations performed in a particular order, it should be understood that these operations can be rearranged, subdivided, or arranged to form equivalent methods without departing from the teachings of this disclosure. Therefore, unless specifically indicated herein, the order and grouping of operations do not limit this disclosure.

Claims

1. An electronic acupuncture needle, characterized in that, include: The needle body has a needle tip and a handle; A flexible sensing region is spirally attached to the surface of the needle tip via a first connecting structure, and the flexible sensing region includes at least one field-effect transistor sensing unit. The signal processing area is electrically connected to the flexible sensing area via wires; The gate of the field-effect transistor sensing unit is coupled to the body fluid at the tip of the needle through a functional layer covering the surface, forming a liquid gate coupling.

2. The electronic acupuncture needle according to claim 1, characterized in that, The first connection structure is a peelable adhesive layer.

3. The electronic acupuncture needle according to claim 1, characterized in that, A reference electrode material layer is provided on the surface of the needle tip.

4. The electronic acupuncture needle according to claim 1, characterized in that, The flexible sensing region includes a flexible substrate, and the field-effect transistor sensing unit is disposed on the flexible substrate.

5. The electronic acupuncture needle according to claim 1, characterized in that, The functional layer is detachably covered on the gate surface of the field-effect transistor sensing unit through a second connection structure; Preferably, the functional layer includes an identification layer, a current limiting layer, and a protection layer stacked sequentially from bottom to top.

6. The electronic acupuncture needle according to claim 5, characterized in that, The second connection structure is a pluggable snap-fit ​​structure or an adsorbable magnetic structure.

7. A method for manufacturing an electronic acupuncture needle, comprising: A needle body is provided, the needle body having a needle tip and a shank; A flexible sensing region is prepared, wherein the flexible sensing region includes at least one field-effect transistor sensing unit; The flexible sensing area is wound in a spiral shape and attached to the surface of the needle tip through a first connecting structure. The gate of the field-effect transistor sensing unit is coupled to the body fluid through a functional layer to form a liquid gate. The flexible sensing area is electrically connected to the signal processing area via a wire.

8. The method according to claim 7, wherein, Before the flexible sensing area is wound in a spiral shape and attached to the surface of the needle tip through the first connecting structure, the method further includes: A reference electrode material layer is coated on the surface of the needle tip.

9. The method according to claim 7, characterized in that, The method further includes: The functional layer is detachably mounted to the gate surface of the field-effect transistor sensing unit via a second connection structure.

10. The method according to claim 7, characterized in that, The method further includes: The functional layer mounted on the gate surface is replaced by operating the second connection structure.

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