Electronic remaining needle and manufacturing method thereof

Abstract

The invention provides an electronic indwelling needle and a manufacturing method thereof, and the electronic indwelling needle comprises an indwelling needle sleeve which is provided with a tube body; the flexible sensing assembly is fixed on the inner wall of the pipe body through a bonding layer; and the external monitoring area is electrically connected with the flexible sensing assembly through a wire. The flexible sensing assembly is arranged in the tube body channel of the indwelling needle sleeve, on the premise that the appearance, the size and the clinical operation mode of a traditional indwelling needle are kept unchanged, high-precision and continuous real-time monitoring of various target biomarkers is achieved, and meanwhile the stability and the signal reliability of the flexible sensing assembly in the blood flow environment are guaranteed.

Description

TECHNICAL FIELD

[0001] The present disclosure relates to the field of biosensing technology, in particular to an electronic indwelling needle and a manufacturing method thereof. BACKGROUND

[0002] With the growing demand for intensive care medicine and dynamic physiological monitoring, continuous blood index real-time monitoring during critical illness, long-term bedridden patients and complex surgical procedures has become increasingly important. Traditional blood tests rely on intermittent venous blood sampling, which requires blood samples to be sent to the laboratory for centrifugation, separation and biochemical analysis. This process takes a long time and cannot provide continuous data, and there is a risk of blood sample deterioration or hemolysis during transportation, which makes it difficult to meet the clinical needs of real-time condition assessment and timely intervention.

[0003] Currently, existing technologies attempt to achieve continuous monitoring of blood indicators, mainly in the following technical routes: one is intermittent detection based on arterial blood gas analyzers, which has high accuracy but is highly invasive and requires repeated blood sampling, increasing patient pain, infection risk and the workload of medical staff. Two is to combine electrochemical or optical sensing elements with indwelling catheters. However, existing integration solutions often face several key challenges: first, the sensor is connected externally or modularly to the outside of the catheter, changing the original shape and operation feel of the indwelling needle; second, the combination of the flexible part of the sensor and the catheter body is mostly by simple pasting or sleeving, without fully considering the repeated bending and deformation of the indwelling needle during implantation and indwelling due to patient activity, which is prone to sensor detachment, line breakage or functional layer damage due to stress concentration.

[0004] Therefore, how to retain the clinical advantages of traditional indwelling needles such as minimally invasive, flexible and easy to operate, while developing an electronic indwelling needle that can stably and long-term monitor multiple blood biomarkers in situ in real time and seamlessly integrate with existing clinical processes, has become a technical bottleneck that needs to be broken through in the field of critical care and chronic disease monitoring. SUMMARY

[0005] The present disclosure provides an electronic indwelling needle and a manufacturing method thereof.

[0006] In a first aspect, the present disclosure provides an electronic indwelling needle, comprising: an indwelling needle cannula having a tube body; a flexible sensing assembly fixed to the inner wall of the tube body by an adhesive layer; and an external monitoring area electrically connected to the flexible sensing assembly by a lead wire.

[0007] In some optional embodiments, the flexible sensing assembly comprises: a flexible substrate; a field effect transistor sensing array formed on the flexible substrate; and a functional material layer formed on each sensing unit in the field effect transistor sensing array; In some optional embodiments, the metal wires for electrically connecting each sensing unit in the field effect transistor sensing array extend along the axial direction of the tube body and extend in a periodic waveform in a plane parallel to the axial direction of the tube body.

[0008] In some optional embodiments, the main body of the functional material layer is a light-curable high-molecular polymer, and the biological recognition element is dispersed in the main body.

[0009] In some optional embodiments, the flexible sensing assembly further comprises a reference electrode, which is arranged on the flexible substrate side by side with the field effect transistor sensing array.

[0010] In some optional embodiments, the surface of the reference electrode is sequentially covered with a solid-state electrolyte layer, an ion-selective exchange layer, and an anti-pollution layer.

[0011] In some optional embodiments, the adhesive layer is a medical adhesive layer.

[0012] In a second aspect, the present disclosure provides a manufacturing method of an electronic indwelling needle, which comprises: providing an indwelling needle cannula; preparing a flexible sensing assembly; fixing the flexible sensing assembly to the inner wall of the tube body of the indwelling needle cannula through an adhesive layer; and electrically connecting the flexible sensing assembly to an external monitoring area through a wire.

[0013] In some optional embodiments, the preparation of the flexible sensing assembly comprises: electrically connecting each sensing unit through a metal wire on the flexible substrate to form a field effect transistor sensing array; forming a functional material layer on each sensing unit.

[0014] In some optional embodiments, the formation of the functional material layer on each sensing unit comprises: spin-coating a functional material precursor on the surface of each sensing unit; selectively exposing the functional material precursor to light to solidify the functional material precursor in the target sensing area of the sensing unit; removing the un-solidified functional material precursor to form a functional material layer in the target sensing area.

[0015] In some optional embodiments, the preparation of the flexible sensing assembly further comprises: forming a reference electrode on the flexible substrate; sequentially coating a solid-state electrolyte layer, an ion-selective exchange layer, and an anti-pollution layer on the surface of the reference electrode.

[0016] To solve the problems of complicated detection process, poor timeliness and inability to continuous monitoring in the existing blood monitoring technology, the present disclosure provides an electronic indwelling needle and a manufacturing method thereof. The electronic indwelling needle realizes high-precision, continuous real-time monitoring of multiple target biomarkers by embedding a flexible sensing assembly in the tube channel of the indwelling needle cannula, while keeping the traditional indwelling needle shape, size and clinical operation mode unchanged, and ensuring the stability and signal reliability of the flexible sensing assembly in the blood flow environment. BRIEF DESCRIPTION OF DRAWINGS

[0017] Other features, objects and advantages of the present disclosure will become more apparent from the following detailed description of non-limiting embodiments made with reference to the accompanying drawings: Figure 1 is a structural schematic diagram of an electronic indwelling needle according to an embodiment of the present disclosure; Figure 2 is a structural schematic diagram of a flexible sensing assembly in the present disclosure.

[0018] Explanation of reference signs / symbols: 100-electronic indwelling needle; 101-tube body; 20-flexible sensing assembly; 201-field effect transistor sensing array; 202-reference electrode; 203-metal wire; 30-external monitoring area; 301-wire. DETAILED DESCRIPTION

[0019] The specific embodiments of the present disclosure will be described below in conjunction with the accompanying drawings and examples, and those skilled in the art can clearly and completely understand the technical solutions of the present disclosure, the technical problems solved and the technical effects produced through the content recorded in the specification. It can be understood that the specific embodiments described herein are only used to explain the present disclosure, but not to limit the present disclosure. In addition, only parts related to the present disclosure are shown in the drawings for ease of description.

[0020] It should be noted that the structures, proportions, sizes, etc. shown in the drawings of the specification are only used to cooperate with the content recorded in the specification for those skilled in the art to understand and read, and do not have technical significance to limit the conditions that the present disclosure can be implemented. Any modification of structure, change of proportion relationship or adjustment of size, which does not affect the effects that the present disclosure can produce and the purposes that the present disclosure can achieve, shall fall within the scope of the technical content disclosed by the present disclosure.

[0021] The terms "first", "second", "the", "said", and the like, as used in the specification and in claims, do not imply a quantity limitation, but rather are used to distinguish between other elements. The terms "comprises", "comprising", "includes", "including", "has", "having" and their conjugates, as used in the specification and in claims, specify the presence of the stated features but do not preclude the presence or addition of one or more other features. The term "connected" or "coupled" or similar terms as used in the specification and in claims are not limited to the physical or mechanical connection or coupling, but also include an electrical connection or coupling.

[0022] Reference Figures 1 to 2 , Figure 1 is a structural schematic diagram of an embodiment of the electronic indwelling needle 100 according to the present disclosure, Figure 2 is a structural schematic diagram of the flexible sensing assembly 20 in the present disclosure.

[0023] As shown in Figure 1 and Figure 2 , the present disclosure provides an electronic indwelling needle 100, which can include: an indwelling needle cannula (not shown in the figure) having a tube body 101; a flexible sensing assembly 20 fixed to the inner wall of the tube body 101 by an adhesive layer (not shown in the figure); and an external monitoring area 30 electrically connected to the flexible sensing assembly 20 by a wire 301. Figure 2 Figure 2 Here, the indwelling needle cannula is an elongated and hollow flexible catheter, and the main body part thereof is the tube body 101. The tube body 101 is usually made of a medical-grade polymer material (such as polyurethane, polytetrafluoroethylene, etc.) with excellent biocompatibility, and the outer diameter and length of the tube body 101 meet the clinical standard for intravenous indwelling. The indwelling needle cannula is used for puncture and indwelling in the blood vessel to provide a channel for infusion, blood transfusion or drug delivery, and the inner wall of the tube body 101 provides a carrier space for the integrated flexible sensing assembly 20, so that the flexible sensing assembly 20 can be in direct contact with the blood flowing therethrough.

[0024] The external monitoring area 30 is a signal processing and display unit located outside the body, which is electrically connected to the flexible sensing assembly 20 implanted in the blood vessel through the wire 301, and is responsible for receiving the electrical signal generated by the flexible sensing assembly 20, amplifying, filtering, analog-to-digital converting and data analyzing the electrical signal, and finally displaying the processed information such as the concentration of biomarkers in digital or graphical form in real time for medical personnel to monitor.

[0025] The external monitoring area 30 is a signal processing and display unit located outside the body, which is electrically connected to the flexible sensing assembly 20 implanted in the blood vessel through the wire 301, and is responsible for receiving the electrical signal generated by the flexible sensing assembly 20, amplifying, filtering, analog-to-digital converting and data analyzing the electrical signal, and finally displaying the processed information such as the concentration of biomarkers in digital or graphical form in real time for medical personnel to monitor.

[0026] ​By fixing the flexible sensing assembly 20 to the inner wall of the indwelling needle cannula, direct contact and continuous monitoring of the flexible sensing assembly 20 with blood are achieved, while ensuring that the original infusion function of the indwelling needle is not affected; the flexible sensing assembly 20 is electrically connected to the external monitoring area 30 through the wire 301, overcoming the defects of long time consumption and inability to continuously monitor in traditional blood detection.

[0027] In some optional embodiments, the flexible sensing assembly 20 can include: a flexible substrate (not shown in the figure); a field effect transistor sensing array 201 formed on the flexible substrate; and a functional material layer (not shown in the figure) formed on each sensing unit in the field effect transistor sensing array 201. Figure 1 Figure 1 In some optional embodiments, the flexible sensing assembly 20 can include: a flexible substrate (not shown in the figure); a field effect transistor sensing array 201 formed on the flexible substrate; and a functional material layer (not shown in the figure) formed on each sensing unit in the field effect transistor sensing array 201.

[0028] Here, the flexible substrate is a thin and bendable substrate material, preferably a medical grade polymer such as polyimide, polyethylene terephthalate or polydimethylsiloxane. The flexible substrate serves as a carrier for supporting and integrating the field effect transistor sensing array 201, the metal wire 203 and the functional material layer, so that it can maintain structural integrity and electrical stability when the indwelling needle cannula is bent.

[0029] Each sensing unit in the field effect transistor sensing array 201 is composed of a source, a drain, a gate and a semiconductor channel. The gate is designed in a liquid gate structure, with blood environment as the gate dielectric. The fixed gate potential is applied to the blood through the reference electrode 202. When the concentration of the target biomarker in the blood changes, it will cause the surface charge state of the semiconductor channel to change, thereby modulating the source-drain current, and finally converting the biochemical reaction signal into a detectable electrical signal change.

[0030] Here, the metal wire 203 for electrically connecting each sensing unit in the field effect transistor sensing array 201 extends along the axial direction of the tube body 101, and extends in a periodic waveform in a plane parallel to the axial line of the tube body 101. This periodic waveform extension can effectively absorb and disperse the mechanical stress generated by bending and twisting of the indwelling needle cannula during implantation or use, avoiding the breakage of the metal wire 203 due to stress concentration, thereby ensuring the long-term reliable operation of the flexible sensing assembly 20 in the dynamic blood vessel environment.

[0031] In some optional embodiments, the main body of the functional material layer can be a light-curable high molecular polymer, with a biological recognition element dispersed therein.

[0032] ​Here, the functional material layer uses a photocurable biocompatible polymer as the main matrix, with biometric elements dispersed within it. When the target biomarker binds to the biometric elements in the functional material layer, it causes changes in the charge distribution, dielectric constant, or ion concentration of the functional material layer, thereby effectively regulating the carrier concentration and conductivity of the semiconductor channel and converting biochemical reaction signals into measurable electrical signals.

[0033] As examples, biorecognition elements can be, but are not limited to, enzyme-based recognition elements, antibody-based recognition elements, aptamer-based recognition elements, or nucleic acid probe-based recognition elements. Enzyme-based recognition elements (such as glucose oxidase, lactate oxidase, etc.) catalyze specific substrate reactions, generating electronic or ionic changes. Antibody-based recognition elements cause changes in surface charge through the specific binding of antigens and antibodies. Aptamer-based and nucleic acid probe-based recognition elements can recognize specific molecules or gene sequences through conformational changes or hybridization reactions. These biorecognition elements are encapsulated in photocurable polymers, collectively forming a functional material layer with high selectivity and sensitivity, directly determining the detection specificity of the flexible sensing component 20 for different target biomarkers.

[0034] By modifying the semiconductor channels of different sensing units with functional material layers containing different biometric elements, parallel and specific detection of multiple target biomarkers can be achieved.

[0035] refer to Figure 1 The flexible sensing component 20 may also include a reference electrode 202, which is disposed side by side with the field-effect transistor sensing array 201 on the flexible substrate.

[0036] Here, the reference electrode 202 is used to provide a stable and known reference potential when the field-effect transistor sensing array 201 is working, so as to accurately control the gate voltage of each sensing unit in the field-effect transistor sensing array 201 and ensure the accuracy, stability and repeatability of the detection signal. The reference electrode 202 is an Ag / AgCl electrode, which is composed of a silver substrate and a silver chloride layer formed on its surface to form a stable electrode pair.

[0037] The reference electrode 202 and the field-effect transistor sensing array 201 are both fabricated on the same surface of the flexible substrate, and are arranged side by side along the length of the flexible substrate (consistent with the axial direction of the tube 101). The electrode region of the reference electrode 202 and the semiconductor channel region of the field-effect transistor sensing array 201 are spatially independent of each other, and are electrically connected by metal wires 203 integrated on the flexible substrate.

[0038] By integrating the reference electrode 202 and the field-effect transistor sensing array 201 onto the same flexible substrate, the structural compactness, implantation applicability, and long-term operational reliability of the entire flexible sensing component 20 are significantly improved while ensuring potential stability and detection accuracy.

[0039] In some alternative embodiments, the surface of the reference electrode 202 may be sequentially covered with a solid electrolyte layer, an ion-selective exchange layer, and an anti-fouling layer.

[0040] Here, the solid electrolyte layer is a polymer gel with certain ionic conductivity, directly covering the surface of the reference electrode 202 to provide stable ion migration channels and reduce the dissolution of silver chloride. The ion-selective exchange layer is a polymer membrane with ion-selective permeability, covering the solid electrolyte layer to selectively allow specific ions to pass through and block the penetration of other interfering ions in the blood, thereby maintaining the stability of the electrode potential. The antifouling layer is a hydrophilic bioinert coating, serving as the outermost layer, to reduce the non-specific adsorption of biomolecules such as proteins in the blood on the electrode surface, thereby significantly improving the biocompatibility and potential stability of the reference electrode 202 during long-term use.

[0041] By constructing a solid electrolyte layer, an ion-selective exchange layer, and an anti-fouling layer on the surface of the reference electrode 202, interference from complex ions in the blood is effectively blocked, significantly improving the long-term potential stability, anti-interference ability, and biocompatibility of the reference electrode 202 in the complex blood environment in vivo.

[0042] In some alternative implementations, the adhesive layer may be a medical adhesive layer.

[0043] As an example, the medical adhesive layer uses a biocompatible thermosetting medical adhesive, which is applied between the flexible substrate and the inner wall of the tube 101 through a coating process. Under heating conditions, the medical adhesive layer undergoes a cross-linking reaction to form a stable adhesive interface, which can achieve a firm fit between the flexible sensing component 20 and the indwelling needle cannula without affecting the overall flexibility of the indwelling needle.

[0044] By using a medical adhesive layer as the bonding layer, a firm, stable and flexible bond is achieved between the flexible sensing component 20 and the inner wall of the indwelling needle cannula, thereby ensuring the structural integrity and functional safety of the electronic indwelling needle 100 during long-term clinical indwelling monitoring.

[0045] This disclosure provides a method for manufacturing an electronic indwelling needle 100, the method including: The first step is to provide an indwelling needle cannula.

[0046] The second step is to prepare the flexible sensing component 20.

[0047] It is understandable that the indwelling needle cannula can be provided first, and then the flexible sensing component 20 can be fabricated. Alternatively, the flexible sensing component 20 can be fabricated first, and then the indwelling needle cannula can be provided.

[0048] The third step is to fix the flexible sensing component 20 to the inner wall of the tube body 101 of the indwelling needle cannula using an adhesive layer.

[0049] The fourth step is to electrically connect the flexible sensing component 20 to the external monitoring area 30 via the wire 301.

[0050] Here, in fabricating the flexible sensing component 20, a flexible substrate is first provided. Metal wires 203 and electrode patterns are formed on the flexible substrate using photolithography and metal deposition processes to construct a field-effect transistor sensing array 201. Then, in the semiconductor channel region of each sensing unit, a functional material precursor containing biometric elements is applied by spin coating, microdroplet dispensing, or printing. Mask alignment and selective ultraviolet light exposure are used to solidify the functional material precursor in the target area. Uncured portions are then removed by development, thereby forming a patterned functional material layer with specific recognition functions on each sensing unit. Optionally, a reference electrode 202 is also fabricated on the flexible substrate, and a solid electrolyte layer, an ion-selective exchange layer, and an anti-fouling layer are formed on the surface of the reference electrode 202 through a layer-by-layer coating and curing process. Finally, the flexible sensing component 20, matching the size of the indwelling needle cannula, is obtained by cutting or laser processing.

[0051] By integrating a flexible sensing component 20 based on a field-effect transistor sensing array 201 into the inner wall of the indwelling needle cannula, real-time, continuous, and in-situ monitoring of multiple target biomarkers is achieved under single-puncture indwelling conditions, thus providing a medical testing solution with high timeliness, high accuracy, and low invasiveness for clinical critical care, surgical monitoring, and chronic disease management.

[0052] In some alternative embodiments, fabricating the flexible sensing component 20 may include: Each sensing unit is electrically connected on a flexible substrate via metal wires 203 to form a field-effect transistor sensing array 201, and then a functional material layer is formed on each sensing unit.

[0053] Here, the field-effect transistor sensing array 201 is formed by sequentially performing photolithography patterning, metal sputtering or evaporation, and semiconductor channel material deposition processes on the surface of a flexible substrate, thereby constructing multiple independent sensing units consisting of a source, drain, gate, and semiconductor channel. These sensing units are electrically interconnected by metal wires 203. The metal wires 203 extend along the length of the flexible substrate and exhibit a periodic waveform structure in a plane parallel to the surface of the flexible substrate.

[0054] By fabricating the flexible sensing component 20, a miniature field-effect transistor sensing array 201 was monolithically integrated on a flexible substrate, enabling the flexible sensing component 20 to detect multiple target biomarkers simultaneously and in parallel, thereby significantly improving the detection throughput and integration within a limited space.

[0055] In some alternative implementations, forming a functional material layer on each sensing unit may include: First, functional material precursors are spin-coated onto the surface of each sensing unit.

[0056] Then, the functional material precursor is selectively exposed to solidify the functional material precursor in the target sensing area of ​​the sensing unit.

[0057] Finally, the uncured functional material precursor is removed, and a functional material layer is formed in the target sensing area.

[0058] In practice, a spin-coating process is first used to uniformly coat the surface of each sensing unit of the field-effect transistor sensing array 201 with a mixed solution containing biometric elements (such as enzymes, antibodies, or aptamers) and photocurable polymer prepolymers, forming a functional material precursor film. Subsequently, a pre-designed photomask is aligned and placed over the target sensing area, and selective exposure with ultraviolet light is performed to cause the functional material precursor in the target area to undergo a cross-linking reaction and solidify. After exposure, the substrate is immersed in or sprayed with a developing solution (such as an organic solvent or alkaline aqueous solution) to dissolve and remove the uncured functional material precursor, ultimately forming a functional material layer only on the semiconductor channel surface of the target sensing area.

[0059] By employing a process combining spin coating, selective exposure, and development to form a functional material layer on the surface of the sensing unit, parallel detection capabilities for multiple target biomarkers are integrated on a single flexible sensing component 20, achieving stability and detection specificity for each sensing unit.

[0060] In some alternative embodiments, fabricating the flexible sensing component 20 may further include: First, a reference electrode 202 is formed on a flexible substrate. And... Secondly, a solid electrolyte layer, an ion-selective exchange layer, and an anti-fouling layer are sequentially coated on the surface of the reference electrode 202.

[0061] In the specific implementation, a silver layer is first formed on a predetermined area of ​​a flexible substrate by physical vapor deposition or electrochemical deposition. Then, silver chloride is generated in situ on the surface of the flexible substrate by electrochemical chlorination or chemical oxidation, thereby preparing the Ag / AgCl reference electrode 202. Subsequently, a polymer solution containing a chloride ion source (such as polyvinyl alcohol-potassium chloride gel) is uniformly coated onto the Ag / AgCl surface by spin coating or spraying, and then cured by heating or ultraviolet light to form a solid electrolyte layer. Next, a polymer membrane material with ion-selective permeability is coated onto the solid electrolyte layer by dip coating or spraying, and after drying, an ion-selective exchange layer is formed. Finally, a hydrophilic anti-biofouling polymer is modified onto the ion-selective exchange layer by surface grafting, spraying, or spin coating, and after curing, an antifouling layer is formed.

[0062] By sequentially coating the surface of the reference electrode 202 with a solid electrolyte layer, an ion-selective exchange layer, and an anti-fouling layer, the potential stability, anti-interference ability, and biocompatibility of the reference electrode 202 are significantly enhanced, ensuring the signal accuracy and reliability of the sensor during long-term continuous monitoring.

[0063] 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 indwelling needle, characterized in that, include: An indwelling needle cannula, having a tube body; A flexible sensing component is fixed to the inner wall of the tube by an adhesive layer; The external monitoring area is electrically connected to the flexible sensing component via wires.

2. The electronic indwelling needle according to claim 1, characterized in that, The flexible sensing component includes: Flexible substrate; A field-effect transistor sensing array formed on the flexible substrate; and A functional material layer formed on each sensing unit in the field-effect transistor sensing array; The metal wires used to electrically connect each sensing unit in the field-effect transistor sensing array extend along the axial direction of the tube body and extend in a periodic waveform in a plane parallel to the axis of the tube body.

3. The electronic indwelling needle according to claim 2, characterized in that, The main body of the functional material layer is a photocurable polymer, with biometric elements dispersed therein.

4. The electronic indwelling needle according to claim 1, characterized in that, The flexible sensing component also includes a reference electrode, which is disposed side by side with the field-effect transistor sensing array on the flexible substrate.

5. The electronic indwelling needle according to claim 4, characterized in that, The surface of the reference electrode is sequentially covered with a solid electrolyte layer, an ion selective exchange layer, and an anti-fouling layer.

6. The electronic indwelling needle according to claim 1, characterized in that, The adhesive layer is a medical adhesive layer.

7. A method for manufacturing an electronic indwelling needle, comprising: Provide indwelling needle cannulas; Fabrication of flexible sensing components; The flexible sensing component is fixed to the inner wall of the indwelling needle cannula by an adhesive layer; The flexible sensing component is electrically connected to the external monitoring area via wires.

8. The method according to claim 7, wherein, The fabrication of the flexible sensing component includes: Each sensing unit is electrically connected by metal wires on a flexible substrate to form a field-effect transistor sensing array. A functional material layer is formed on each of the aforementioned sensing units.

9. The method according to claim 8, wherein, The formation of a functional material layer on each of the sensing units includes: A functional material precursor is spin-coated onto the surface of each of the aforementioned sensing units; The functional material precursor is selectively exposed to solidify the functional material precursor in the target sensing area of ​​the sensing unit. Remove the uncured functional material precursor and form the functional material layer in the target sensing area.

10. The method according to claim 7, wherein, The fabrication of the flexible sensing component further includes: A reference electrode is formed on a flexible substrate; A solid electrolyte layer, an ion-selective exchange layer, and an anti-fouling layer are sequentially coated on the surface of the reference electrode.

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