Electrode device, sensor, and method for manufacturing electrode device

Abstract

An electrode device (100), a sensor, and a method for manufacturing the electrode device (100). The electrode device (100) comprises: a flexible substrate (20) comprising a first plate portion (21) and a second plate portion (22) that are folded along a symmetry line (201) and coincide with each other; and an electrode structure (40), the electrode structure (40) comprising at least one first electrode (41) and at least one second electrode (42), wherein the at least one first electrode (41) is located on the side of the first plate portion (21) facing away from the second plate portion (22), and the at least one second electrode (42) is located on the side of the second plate portion (22) facing away from the first plate portion (21). By means of the embodiment, the manufacturing precision of the electrode device (100) can be improved, and the manufacturing difficulty of the electrode device (100) can be reduced.

Description

Electrode device, sensor, and method for manufacturing electrode device

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to the Chinese patent application filed with the State Intellectual Property Office of China on November 15, 2023, with application number 202311527999.0 and application name “Electrode device, sensor, and method for manufacturing an electrode device,” the entire contents of which are incorporated by reference into this application. Technical Field

[0003] The present disclosure relates to the field of sensor technology, and in particular to an electrode device, a sensor, and a method for manufacturing the electrode device. Background Art

[0004] Electrochemical biosensors, integrating electronic detection technology with biological science, have become a new branch of sensor technology. As a commonly used method for detecting body fluids, electrochemical biosensors are widely used in in vitro diagnostics and real-time monitoring of blood glucose, blood ketones, lactate, and uric acid. For example, continuous glucose monitoring (CGM) systems utilize subcutaneously implanted electrochemical biosensors to monitor blood glucose levels over long periods of time.

[0005] The electrode assembly is a key component of an electrochemical biosensor. It generally includes a working electrode and a biosensitive material layer (such as an enzyme, antibody, or nucleic acid) disposed on the working electrode. The biosensitive material layer is used to electrochemically react with specific molecules of the target analyte (such as proteins, carbohydrates, or drugs). The working electrode is used to convert the electrochemical reaction into a corresponding electrical signal and output it through a circuit. Analysis of the electrical signal enables quantitative or qualitative detection of the target analyte. The electrode assembly is typically small. For example, the electrode assembly of a CGM electrochemical biosensor is typically around 10 mm long and no more than 0.5 mm in diameter.

[0006] How to improve the manufacturing accuracy of the electrode device and reduce its manufacturing difficulty is a technical problem that needs to be solved urgently by those skilled in the art.

[0007] Summary of the Invention

[0008] The present disclosure provides an electrode device, a sensor, and a method for manufacturing the electrode device, so as to improve the manufacturing accuracy of the electrode device and reduce the manufacturing difficulty thereof.

[0009] According to one aspect of the present disclosure, an electrode device is provided, comprising: a flexible substrate, comprising a first plate portion and a second plate portion folded and overlapped along a line of symmetry; and an electrode structure, the electrode structure comprising at least one first electrode and at least one second electrode, wherein the at least one first electrode is located on a side of the first plate portion facing away from the second plate portion, and the at least one second electrode is located on a side of the second plate portion facing away from the first plate portion.

[0010] In some embodiments, at least one first electrode includes multiple first electrodes, and at least one second electrode includes multiple second electrodes, wherein the multiple first electrodes include a first working electrode and a first counter electrode, and the multiple second electrodes include a second working electrode and a second counter electrode; or, the multiple first electrodes include a first working electrode, a first counter electrode, and a first reference electrode, and the multiple second electrodes include a second working electrode, a second counter electrode, and a second reference electrode.

[0011] In some embodiments, at least one first electrode includes multiple first electrodes, and at least one second electrode includes multiple second electrodes, wherein the multiple first electrodes include a first working electrode and a first counter electrode, and the multiple second electrodes include a second working electrode aligned back to back with the first working electrode, and a second counter electrode aligned back to back with the first counter electrode; or, the multiple first electrodes include a first working electrode, a first counter electrode and a first reference electrode, and the multiple second electrodes include a second working electrode aligned back to back with the first working electrode, a second counter electrode aligned back to back with the first counter electrode, and a second reference electrode aligned back to back with the first reference electrode.

[0012] In some embodiments, the electrode device also includes: a first biosensitive substance layer, located on the side of the first working electrode facing away from the first plate portion; at least one first biofunctional layer, covering multiple first electrodes and the first biosensitive substance layer; a second biosensitive substance layer, located on the side of the second working electrode facing away from the second plate portion; and, at least one second biofunctional layer, covering multiple second electrodes and the second biosensitive substance layer.

[0013] In some embodiments, the first biosensitive substance layer and the second biosensitive substance layer contain the same or different biosensitive substance components.

[0014] In some embodiments, the electrode device also includes: at least one first electrical connection portion, located on the side of the first plate portion facing away from the second plate portion and arranged in a one-to-one correspondence with at least one first electrode; at least one first lead, located on the side of the first plate portion facing away from the second plate portion and connecting at least one first electrode to at least one first electrical connection portion; at least one second electrical connection portion, located on the side of the second plate portion facing away from the first plate portion and arranged in a one-to-one correspondence with at least one second electrode; and, at least one second lead, located on the side of the second plate portion facing away from the first plate portion and connecting at least one second electrode to at least one second electrical connection portion.

[0015] In some embodiments, the first plate portion includes a first portion extending along a first direction, and a second portion extending along a second direction intersecting the first direction, wherein at least one first electrode is provided in the first portion, and at least one first electrical connection portion is provided in the second portion; the second plate portion includes a third portion extending along the first direction, and a fourth portion extending along the second direction, wherein at least one second electrode is provided in the third portion, and at least one second electrical connection portion is provided in the fourth portion.

[0016] In some embodiments, at least one first electrode includes multiple first electrodes, and at least one first electrical connection portion includes multiple first electrical connection portions, wherein the multiple first electrodes are arranged in sequence along the first direction, and the multiple first electrical connection portions are arranged in sequence along the second direction; and / or, at least one second electrode includes multiple second electrodes, and at least one second electrical connection portion includes multiple second electrical connection portions, wherein the multiple second electrodes are arranged in sequence along the first direction, and the multiple second electrical connection portions are arranged in sequence along the second direction.

[0017] In some embodiments, the first direction is orthogonal to the second direction, and the symmetry line extends along the first direction or along the second direction.

[0018] In some embodiments, the flexible substrate is provided with a folding notch at at least one end of the symmetry line.

[0019] In some embodiments, a surface of the first plate portion facing the second plate portion is welded or bonded to a surface of the second plate portion facing the first plate portion.

[0020] In some embodiments, the flexible substrate has a thickness ranging from 0.01 mm to 0.3 mm.

[0021] According to one aspect of the present disclosure, a sensor is provided, comprising the electrode device according to any one of the aforementioned embodiments.

[0022] According to one aspect of the present disclosure, a method for manufacturing an electrode device is provided, comprising:

[0023] Providing a flexible substrate, the flexible substrate comprising a first plate portion and a second plate portion that are symmetrical with respect to a symmetry line;

[0024] forming an electrode structure on one side of the flexible substrate, wherein the electrode structure includes at least one first electrode located on the first plate portion and at least one second electrode located on the second plate portion; and

[0025] The first plate portion and the second plate portion are folded along a symmetry line, and a side of the first plate portion facing away from the electrode structure faces a side of the second plate portion facing away from the electrode structure.

[0026] In some embodiments, the manufacturing method also includes: before folding the first plate portion and the second plate portion along the symmetry line, forming on one side of the flexible substrate at least one first electrical connection portion located in the first plate portion and arranged in one-to-one correspondence with at least one first electrode, at least one first lead located in the first plate portion and correspondingly connecting at least one first electrode with the at least one first electrical connection portion, at least one second electrical connection portion located in the second plate portion and correspondingly connecting at least one second electrode with the at least one second lead located in the second plate portion and correspondingly connecting at least one second electrode with the at least one second electrical connection portion.

[0027] In some embodiments, the at least one first electrode includes a plurality of first electrodes, and the at least one second electrode includes a plurality of second electrodes, wherein the plurality of first electrodes include a first working electrode and a first counter electrode, and the plurality of second electrodes include a second working electrode and a second counter electrode; or, the plurality of first electrodes include a first working electrode, a first counter electrode, and a first reference electrode, and the plurality of second electrodes include a second working electrode, a second counter electrode, and a second reference electrode; and the manufacturing method further includes:

[0028] Before folding the first plate portion and the second plate portion along the symmetry line, or after folding the first plate portion and the second plate portion along the symmetry line, a first biosensitive substance layer is formed on the side of the first working electrode facing away from the first plate portion; at least one first biofunctional layer covering multiple first electrodes and the first biosensitive substance layer is formed; a second biosensitive substance layer is formed on the side of the second working electrode facing away from the second plate portion; and at least one second biofunctional layer covering multiple second electrodes and the second biosensitive substance layer is formed.

[0029] In some embodiments, the first biosensitive substance layer and the second biosensitive substance layer contain the same or different biosensitive substance components.

[0030] In some embodiments, the manufacturing method further includes: after folding the first plate portion and the second plate portion along the symmetry line, welding or bonding a side of the first plate portion facing away from the electrode structure to a side of the second plate portion facing away from the electrode structure.

[0031] According to one or more embodiments of the present disclosure, since the electrode structure is manufactured on a single side of the flexible substrate, there is no need to consider the alignment when manufacturing the structure on the other side of the substrate as in the related art. Therefore, the manufacturing accuracy of the electrode device can be improved and its manufacturing difficulty can be reduced.

[0032] It should be understood that the contents described in this section are not intended to identify the key or important features of the embodiments of the present disclosure, nor are they intended to limit the scope of the present disclosure. Other features of the present disclosure will become readily understood through the following description. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] The accompanying drawings illustrate exemplary embodiments and constitute a part of the specification. Together with the description of the specification, they serve to explain exemplary implementation of the embodiments. The illustrated embodiments are for illustrative purposes only and do not limit the scope of the claims. Throughout the drawings, the same reference numerals designate similar, but not necessarily identical, elements.

[0034] FIG1 is a schematic diagram showing a top view of the electrode device according to some embodiments of the present disclosure before the flexible substrate is folded;

[0035] FIG2 is a schematic diagram showing a partial cross-sectional structure of an electrode device according to some embodiments of the present disclosure after the flexible substrate is folded;

[0036] FIG3 shows a schematic diagram of a partial cross-sectional structure of an electrode device according to some embodiments of the present disclosure after the flexible substrate is folded;

[0037] FIG4 is a schematic diagram showing a top view of the electrode device according to some embodiments of the present disclosure before the flexible substrate is folded;

[0038] FIG5 is a schematic diagram showing a cross-sectional structure of an electrode device according to some embodiments of the present disclosure before the flexible substrate is folded;

[0039] FIG6 is a schematic flow chart showing a method for manufacturing an electrode device according to some embodiments of the present disclosure.

[0040] Reference numerals:

[0041] 100 - electrode device; 20 - flexible substrate; 201 - symmetry line; 202 - folding notch; 21 - first plate portion;

[0042] 22 - second plate portion; 40 - electrode structure; 41 - first electrode; 411 - first working electrode;

[0043] 412 - first counter electrode; 413 - first reference electrode; 42 - second electrode; 421 - second working electrode;

[0044] 422 - second pair of electrodes; 423 - second reference electrode; 51 - first biosensitive material layer;

[0045] 52-second biosensitive material layer; 61-first biofunctional layer; 62-second biofunctional layer;

[0046] 71 - first electrical connection portion; 72 - second electrical connection portion; 81 - first lead wire; 82 - second lead wire;

[0047] 211-Part 1; 212-Part 2; 221-Part 3; 222-Part 4;

[0048] S1-first direction; S2-second direction; 600-manufacturing method; S601~S603-steps. DETAILED DESCRIPTION

[0049] The following description of exemplary embodiments of the present disclosure is made in conjunction with the accompanying drawings, including various details of the embodiments of the present disclosure to facilitate understanding, which should be considered as merely exemplary. Therefore, it should be appreciated by those skilled in the art that various changes and modifications may be made to the embodiments described herein without departing from the scope of the present disclosure. Similarly, for the sake of clarity and conciseness, descriptions of well-known functions and structures are omitted in the following description.

[0050] In this disclosure, unless otherwise specified, the use of terms such as "first" and "second" to describe various elements is not intended to limit the positional relationship, temporal relationship, or importance relationship of these elements. Such terms are only used to distinguish one element from another. In some examples, the first element and the second element may refer to the same instance of the element, while in some cases, based on the context of the description, they may also refer to different instances.

[0051] The terms used in the descriptions of various examples in this disclosure are for the purpose of describing specific examples only and are not intended to be limiting. Unless the context clearly indicates otherwise, if the number of elements is not specifically limited, the element may be one or more. In addition, the term "and / or" used in this disclosure encompasses any one and all possible combinations of the listed items.

[0052] In the field of electrochemistry, an electrode system generally includes a working electrode, and may also include a counter electrode and a reference electrode. The working electrode, also known as the research electrode, refers to the electrode on which the reaction being studied occurs. The counter electrode, also known as the auxiliary electrode, forms a circuit with the working electrode to allow the current of the working electrode to flow smoothly so that the reaction being studied can reliably occur on the working electrode. The reference electrode refers to an electrode with a known potential that is close to an ideal non-polarizable electrode. There is basically no current passing through the reference electrode, and it is used to measure the electrode potential of the working electrode relative to the reference electrode. In some application scenarios, the electrode system may not include a reference electrode.

[0053] In some related technologies, the manufacturing process of the electrode device of the electrochemical sensor includes: first, a working electrode, a first insulating layer, a reference electrode and a second insulating layer are manufactured in sequence on one side of the substrate; then, a counter electrode and a third insulating layer are manufactured in sequence on the other side of the substrate.

[0054] This related technology has the following technical defects: since it involves the separate production and alignment of electrodes on both sides of the substrate, the production process is complicated and difficult to produce; due to the limitation of process precision capability, some electrodes with higher precision requirements (such as working electrodes and reference electrodes) can only be produced in stacked layers, which further increases the complexity and difficulty of the process; due to the limitation of process precision capability, it is usually only suitable for producing a single electrode system including a working electrode on the substrate, so that the electrode device can only be used for one functional monitoring.

[0055] In this article, “alignment” can be understood as adjusting the target object relative to the reference benchmark to within the error range that meets the accuracy requirements.

[0056] Based on this, the embodiments of the present disclosure provide an electrode device, a sensor, and a method for manufacturing an electrode device, which can improve the manufacturing accuracy of the electrode device and reduce its manufacturing difficulty.

[0057] The embodiments of the present disclosure will be described in detail below with reference to the accompanying drawings.

[0058] As shown in Figures 1 and 2, Figure 1 shows a schematic top view of the electrode device 100 according to some embodiments of the present disclosure before the flexible substrate 20 is folded, and Figure 2 shows a schematic partial cross-sectional view of the electrode device 100 according to some embodiments of the present disclosure after the flexible substrate 20 is folded. The product form of the electrode device 100 can be referred to as shown in Figure 2, where the flexible substrate 20 is in a folded state.

[0059] As shown in Figures 1 and 2, an electrode device 100 provided in some embodiments of the present disclosure includes a flexible substrate 20 and an electrode structure 40. The flexible substrate 20 includes a first plate portion 21 and a second plate portion 22 that are folded and overlapped along a symmetry line 201. The electrode structure 40 includes at least one first electrode 41 and at least one second electrode 42, wherein the at least one first electrode 41 is located on a side of the first plate portion 21 facing away from the second plate portion 22, and the at least one second electrode 42 is located on a side of the second plate portion 22 facing away from the first plate portion 21.

[0060] As shown in FIG1 , since it illustrates the top view of the electrode device 100 before the flexible substrate 20 is folded, the side of the first plate portion 21 facing away from the second plate portion 22 and the side of the second plate portion 22 facing away from the first plate portion 21 are located on the same side of the flexible substrate 20. As shown in FIG2 , after the flexible substrate 20 is folded, the side of the first plate portion 21 facing away from the second plate portion 22 and the side of the second plate portion 22 facing away from the first plate portion 21 refer to the two opposite outer sides of the folded flexible substrate 20.

[0061] The electrode structure of the electrode device generally includes a working electrode, that is, at least one of the at least one first electrode 41 and the at least one second electrode 42 is a working electrode (eg, the first working electrode 411 and the second working electrode 421 ).

[0062] In the embodiments of the present disclosure, there is no limitation on the specific product type of the sensor used by the electrode device 100. For example, in some embodiments, the electrode device 100 is applied to an electrochemical biosensor, and the surface of the working electrode thereof is coated with a biosensitive substance layer (the biosensitive substance is, for example, an enzyme, an antibody, or a nucleic acid, etc.), so that the electrochemical biosensor can realize the biological monitoring function of the target analyte (such as monitoring blood glucose, blood ketones, lactic acid, or uric acid, etc.). For example, in some embodiments, the electrode device 100 is applied to an electrochemical sensor, and the surface of the working electrode thereof is coated with a chemically sensitive substance layer, so that the electrochemical sensor can realize the chemical monitoring function of the target analyte (such as monitoring pH, ammonia, oxygen saturation, etc.). For example, in some embodiments, the electrode device 100 is applied to an electrochemical sensor, and the working electrode thereof is made of a specific material or is doped with a specific component, so that the working electrode can directly undergo an electrochemical reaction with a certain component of the target analyte and convert it into a corresponding electrical signal. In these embodiments, the surface of the working electrode does not need to be provided with a chemically sensitive substance layer.

[0063] In the disclosed embodiment, the flexible substrate 20 has an axisymmetric structure. Folding the flexible substrate 20 in half along a line of symmetry 201 allows the first plate portion 21 and the second plate portion 22 to be folded and overlapped (in this disclosure, "overlapping" refers to overlapping within a precision error range). When the flexible substrate 20 is unfolded, the first plate portion 21 and the second plate portion 22 are located on either side of the line of symmetry 201, and are axisymmetric with respect to the line of symmetry 201. In some embodiments, the line of symmetry 201 can be marked on the flexible substrate 20, so that the electrode device 100 can be folded in half with reference to the line of symmetry 201 during fabrication. In other embodiments, the positional information of the line of symmetry 201 of the flexible substrate 20 is stored in relevant production equipment, or the relevant production equipment can calculate the positional information of the line of symmetry 201 of the flexible substrate 20, so that the line of symmetry 201 does not need to be marked on the flexible substrate 20.

[0064] When manufacturing the electrode device 100 of the embodiment of the present disclosure, the electrode structure 40 can be first fabricated on a single surface of the flexible substrate 20, and then the flexible substrate 20 can be folded along the symmetry line 201, thereby forming an electrode device 100 with electrodes on both surfaces. Compared to related technologies, the design of the electrode device 100 of the embodiment of the present disclosure has at least the following technical advantages:

[0065] Since the electrode structure 40 is manufactured on a single side of the flexible substrate 20, there is no need to consider the alignment of the structure on the other side of the substrate as in the related art. Therefore, the manufacturing accuracy of the electrode device 100 can be improved and the manufacturing difficulty can be reduced.

[0066] Since the electrode structure 40 is manufactured in a single layer, it is easy to meet high precision requirements. For example, the width of the first electrode 41 and the second electrode 42 can be easily controlled within the range of 0.1 mm to 0.5 mm. Therefore, there is no need for stacking layers as in the related art, thereby reducing the complexity and difficulty of the process.

[0067] Since the electrode device 100 is manufactured with high precision and low difficulty, it is easy to implement a dual-electrode system design. The dual-electrode system uses two sets of electrode systems to implement two functional monitoring or complementary correction or redundant monitoring of the same functional monitoring.

[0068] Therefore, the design of the electrode device 100 according to the embodiment of the present disclosure can not only improve the manufacturing accuracy of the electrode device 100 and reduce its production cost, but also facilitate the design of a dual-electrode system.

[0069] As shown in FIG1 , in some embodiments of the present disclosure, the structure of the electrode device 100 further includes: at least one first electrical connection portion 71 located on a side of the first plate portion 21 facing away from the second plate portion 22 (since FIG1 illustrates a top view of the electrode device 100 before the flexible substrate 20 is folded, the side of the first plate portion 21 facing away from the second plate portion 22 and the side of the second plate portion 22 facing away from the first plate portion 21 are located on the same side of the flexible substrate 20 in the figure) and correspondingly provided with the at least one first electrode 41; at least one first lead 81 located on a side of the first plate portion 21 facing away from the second plate portion 22 and correspondingly connecting the at least one first electrode 41 to the at least one first electrical connection portion 71; at least one second electrical connection portion 72 located on a side of the second plate portion 22 facing away from the first plate portion 21 and correspondingly provided with the at least one second electrode 42; and at least one second lead 82 located on a side of the second plate portion 22 facing away from the first plate portion 21 and correspondingly connecting the at least one second electrode 42 to the at least one second electrical connection portion 72.

[0070] The first electrical connection portion 71 and the second electrical connection portion 72 are used to connect the electrode device 100 to an external circuit. The first electrical connection portion 71, the first lead 81, the second electrical connection portion 72, and the second lead 82 can be made of the same or different materials, generally different from the material used for the electrode structure 40. They can be located on the same manufacturing layer or on a different manufacturing layer as the electrode structure 40, and the precision requirements are relatively low. In some embodiments, the electrode structure 40 can be first manufactured on one side of the flexible substrate 20, and then the first electrical connection portion 71, the first lead 81, the second electrical connection portion 72, and the second lead 82 can be manufactured on this side of the flexible substrate 20, and then the flexible substrate 20 can be folded along the symmetry line 201. In some embodiments, the first electrical connection portion 71, the first lead 81, the second electrical connection portion 72, and the second lead 82 can be first manufactured on one side of the flexible substrate 20, and then the electrode structure 40 can be manufactured on this side of the flexible substrate 20, and then the flexible substrate 20 can be folded along the symmetry line 201.

[0071] In some embodiments of the present disclosure, the at least one first electrode 41, the at least one first electrical connection portion 71, and the at least one first lead 81 located on the first plate portion 21 constitute a first electrode system, and the at least one second electrode 42, the at least one second electrical connection portion 72, and the at least one second lead 82 located on the second plate portion 22 constitute a second electrode system. The structures of the first electrode system and the second electrode system can be the same or different, and the monitoring functions of the first electrode system and the second electrode system can be the same or different.

[0072] When the monitoring functions of the first electrode system and the second electrode system are designed to be the same, the electrode device 100 can perform dual-channel monitoring of the target analyte, so that the monitoring information of the two sets of electrode systems can be used for complementary correction (for example, using a correction algorithm) to obtain more accurate monitoring data; in addition, when one of the electrode systems fails or malfunctions, the other electrode system can still be used for monitoring, so that the electrode device 100 has higher working reliability and a longer service life.

[0073] When the monitoring functions of the first electrode system and the second electrode system are designed to be different, the electrode device 100 can perform dual-parameter monitoring of the target analyte. For example, one set of electrode systems is used to monitor the blood glucose parameters of the target analyte, and the other set of electrode systems is used to monitor the lactate parameters of the target analyte. In this way, the electrode device 100 can achieve dual-parameter monitoring, with richer monitoring information and greater practicality.

[0074] In other embodiments of the present disclosure, the at least one first electrode 41, the at least one first electrical connection portion 71, and the at least one first lead 81 located on the first plate portion 21 may also collectively constitute an electrode system with the at least one second electrode 42, the at least one second electrical connection portion 72, and the at least one second lead 82 located on the second plate portion 22. For example, two first electrodes 41 serving as a working electrode and a reference electrode, respectively, may be disposed on the first plate portion 21, and one second electrode 42 serving as a counter electrode may be disposed on the second plate portion 22, thereby collectively constituting an electrode system.

[0075] The embodiments of the present disclosure do not limit the specific structural form of the electrode structure 40. As shown in Figures 1 and 2, in some embodiments of the present disclosure, the at least one first electrode 41 includes a plurality of first electrodes 41, and the at least one second electrode 42 includes a plurality of second electrodes 42. The plurality of first electrodes 41 include a first working electrode 411, a first counter electrode 412, and a first reference electrode 413. The plurality of second electrodes 42 include a second working electrode 421 aligned opposite to the first working electrode 411, a second counter electrode 422 aligned opposite to the first counter electrode 412, and a second reference electrode 423 aligned opposite to the first reference electrode 413. The number of first electrical connections 71 and first leads 81 is set accordingly to the number of first electrodes 41, and the number of second electrical connections 72 and second leads 82 is set accordingly to the number of second electrodes 42. In this embodiment, the first electrode system and the second electrode system respectively include a working electrode, a reference electrode, and a counter electrode, forming a three-electrode system.

[0076] In other embodiments of the present disclosure, the at least one first electrode comprises a plurality of first electrodes, and the at least one second electrode comprises a plurality of second electrodes, the plurality of first electrodes comprising a first working electrode and a first counter electrode, and the plurality of second electrodes comprising a second working electrode aligned opposite to the first working electrode, and a second counter electrode aligned opposite to the first counter electrode. In this embodiment, the first electrode system and the second electrode system comprise a working electrode and a counter electrode, respectively, forming a two-electrode system.

[0077] As shown in Figure 2, in the structure of the electrode device 100, multiple first electrodes 41 and multiple second electrodes 42 are aligned in a one-to-one back-to-back relationship. That is, on either side of the folded flexible substrate 20, each first electrode 41 is arranged back-to-back with a second electrode 42, and the contours of each first electrode 41 and second electrode 42 overlap within a tolerance range in a direction perpendicular to the flexible substrate 20. For example, on either side of the folded flexible substrate 20, the first working electrode 411 and the second working electrode 421 (similarly for the first counter electrode 412, the second counter electrode 422, and the first reference electrode 413, the second reference electrode 423) are arranged back-to-back with each other, and the contours of these two electrodes overlap within a tolerance range in a direction perpendicular to the flexible substrate 20. In this way, two sets of electrode systems can monitor the target analyte at the same location, resulting in more accurate sensor data. Because each electrode can be precisely fabricated on a single side of the flexible substrate 20, there is no need to consider the alignment of the substrate fabrication structures on both sides, as in related art, resulting in a lower manufacturing difficulty.

[0078] In some embodiments of the present disclosure, under the premise of meeting product design requirements, the plurality of first electrodes and the plurality of second electrodes may be staggered or partially staggered on both sides of the folded flexible substrate.

[0079] For example, the aforementioned plurality of first electrodes include a first working electrode and a first counter electrode, and the aforementioned plurality of second electrodes include a second working electrode and a second counter electrode. The first electrode system and the second electrode system are two-electrode systems including a working electrode and a counter electrode, respectively. This embodiment does not require consistency in the monitoring positions of the first electrode system and the second electrode system, and the positions of the respective electrodes can be designed accordingly according to their respective monitoring needs. Therefore, the plurality of first electrodes and the plurality of second electrodes can be staggered or partially staggered.

[0080] For example, the aforementioned plurality of first electrodes include a first working electrode, a first counter electrode, and a first reference electrode, and the aforementioned plurality of second electrodes include a second working electrode, a second counter electrode, and a second reference electrode. The first electrode system and the second electrode system are three-electrode systems including a working electrode, a counter electrode, and a reference electrode, respectively. This embodiment does not require consistency in the monitoring positions of the first electrode system and the second electrode system, and the positions of the respective electrodes can be designed accordingly according to their respective monitoring needs. Therefore, the plurality of first electrodes and the plurality of second electrodes can be staggered or partially staggered.

[0081] As shown in FIG3 , in some embodiments of the present disclosure, the electrode assembly 100 further includes: a first biosensitive substance layer 51 located on the side of the first working electrode 411 facing away from the first plate portion 21; at least one first biofunctional layer 61 covering the plurality of first electrodes 41 and the first biosensitive substance layer 51; a second biosensitive substance layer 52 located on the side of the second working electrode 421 facing away from the second plate portion 22; and at least one second biofunctional layer 62 covering the plurality of second electrodes 42 and the second biosensitive substance layer 52. The electrode assembly 100 of this embodiment can be applied to an electrochemical biosensor.

[0082] In some embodiments, the first biosensitive material layer 51 and the second biosensitive material layer 52 contain the same biosensitive material components, for example, the same enzyme, antibody, or nucleic acid. The plurality of first electrodes 41, the plurality of first electrical connectors 71, and the plurality of first leads 81 constitute a first electrode system, while the plurality of second electrodes 42, the plurality of second electrical connectors 72, and the plurality of second leads 82 constitute a second electrode system. The first and second electrode systems have the same monitoring functions. Thus, the electrode assembly 100 can perform dual-channel monitoring of target analytes, utilizing the monitoring information from the two electrode systems for complementary correction, thereby obtaining more accurate monitoring data. Furthermore, if one electrode system fails or malfunctions, monitoring can still be performed using the other electrode system, thus providing greater operational reliability for the electrode assembly 100.

[0083] In some embodiments, the first biosensitive material layer 51 and the second biosensitive material layer 52 contain different biosensitive material compositions. For example, the first biosensitive material layer 51 contains glucose oxidase, while the second biosensitive material layer 52 contains lactate dehydrogenase. The plurality of first electrodes 41, the plurality of first electrical connections 71, and the plurality of first leads 81 constitute a first electrode system for monitoring blood glucose parameters, while the plurality of second electrodes 42, the plurality of second electrical connections 72, and the plurality of second leads 82 constitute a second electrode system for monitoring lactate parameters. The first and second electrode systems have different monitoring functions, allowing for dual-parameter monitoring of target analytes through the electrode device 100, providing richer monitoring information and greater practicality.

[0084] The biofunctional layer can be used to improve and / or control the performance of the electrode device 100. In addition, it can also play a role in connection, protection, structural reinforcement, etc. The number of layers and functions of the first biofunctional layer 61 and the second biofunctional layer 62 can be flexibly designed and selected according to product requirements.

[0085] In some embodiments, at least one of the at least one first biofunctional layer 61 and the at least one second biofunctional layer 62 is a hydrophilic polymer layer with excellent biocompatibility and degradability, and is well compatible with biological tissues. In some embodiments, at least one of the at least one first biofunctional layer 61 and the at least one second biofunctional layer 62 is a flux-limiting layer, which can control the total amount and / or rate of electrochemical reaction between the biosensitive material layer and the target analyte. In some embodiments, at least one of the at least one first biofunctional layer 61 and the at least one second biofunctional layer 62 is an anti-interference layer, which can reduce the interference of certain substances with the electrochemical reaction. In some embodiments, the electrode assembly 100 includes two first biofunctional layers 61 and two second biofunctional layers 62, wherein the two first biofunctional layers 61 are respectively a first flux-limiting layer and a first anti-interference layer in a direction away from the first electrode 41, and the two second biofunctional layers 62 are respectively a second flux-limiting layer and a second anti-interference layer in a direction away from the second electrode 42. In some embodiments, the number of first biofunctional layers 61 and second biofunctional layers 62 included in the electrode assembly 100 can also be different. For example, the first electrode system includes one first biofunctional layer 61 , and the second electrode system includes two second biofunctional layers 62 .

[0086] The embodiments of the present disclosure do not limit the specific shape of the flexible substrate 20, and the flexible substrate 20 may be designed accordingly based on the product requirements of the electrode device 100. As shown in FIG1 , in some embodiments, the first plate portion 21 includes a first portion 211 extending along a first direction S1 and a second portion 212 extending along a second direction S2 intersecting the first direction S1. The at least one first electrode 41 is disposed on the first portion 211, and the at least one first electrical connection portion 71 is disposed on the second portion 212. The second plate portion 22 includes a third portion 221 extending along the first direction S1 and a fourth portion 222 extending along a second direction S2 intersecting the first direction S1. The at least one second electrode 42 is disposed on the third portion 221, and the at least one second electrical connection portion 72 is disposed on the fourth portion 222.

[0087] The first electrode 41 is provided on the first portion 211 , the first electrical connection portion 71 is provided on the second portion 212 , the second electrode 42 is provided on the third portion 221 , and the second electrical connection portion 72 is provided on the fourth portion 222 . In this way, the arrangement of the electrode system on the flexible substrate 20 is more compact and reasonable, which is conducive to achieving a more compact design of the electrode device 100 .

[0088] As shown in FIG1 , in some embodiments, the first direction S1 is orthogonal to the second direction S2, and the symmetry line 201 extends along the first direction S1. As shown in FIG4 , in other embodiments, the first direction S1 is orthogonal to the second direction S2, and the symmetry line 201 extends along the second direction S2. In these embodiments, the flexible substrate 20 is generally T-shaped when unfolded, and the arrangement of the electrode structure 40 is relatively compact. When the flexible substrate 20 is folded, the overall size is relatively compact.

[0089] In other embodiments of the present disclosure, the angle between the first direction S1 and the second direction S2 may also be other angles, such as 45 degrees or 60 degrees. The arrangement of the electrode system on the flexible substrate 20 is also relatively compact.

[0090] As shown in Figures 1 and 4, in some embodiments of the present disclosure, a plurality of first electrodes 41 are arranged in sequence along the first direction S1, and a plurality of first electrical connection portions 71 corresponding one-to-one to the plurality of first electrodes 41 are arranged in sequence along the second direction S2; a plurality of second electrodes 42 are arranged in sequence along the first direction S1, and a plurality of second electrical connection portions 72 corresponding one-to-one to the plurality of second electrodes 42 are arranged in sequence along the second direction S2.

[0091] The design of this embodiment is conducive to reducing the width of the flexible substrate 20 after folding, thereby helping to reduce the width of the electrode device 100, making the structure of the electrode device 100 more compact and the application scenarios more flexible.

[0092] As shown in Figures 1 and 4 , in some embodiments, the flexible substrate 20 has a folding notch 202 at at least one end (or both ends in the figure) of the symmetry line 201. This design can reduce bending stress when the flexible substrate 20 is folded, facilitating accurate folding of the flexible substrate 20 along the symmetry line 201.

[0093] In some embodiments of the present disclosure, the thickness of the flexible substrate 20 is designed to range from 0.01 mm to 0.3 mm. For example, a medical-grade flexible substrate 20 with a thickness of 0.05 mm, 0.1 mm, or 0.2 mm can be used. When the flexible substrate 20 is folded along the symmetry line 201, the thickness of the stacked first and second plate portions 21, 22 ranges from approximately 0.02 mm to 0.6 mm. This thin stack facilitates the thin design of the sensor and facilitates its implantation in vivo.

[0094] The embodiments of the present disclosure do not limit the stacking connection method of the first plate portion 21 and the second plate portion 22. In some embodiments of the present disclosure, as shown in Figure 2, the side of the first plate portion 21 facing the second plate portion 22 and the side of the second plate portion 22 facing the first plate portion 21 can be welded or bonded. In other embodiments of the present disclosure, the first plate portion 21 and the second plate portion 22 can also be secured using other fixing structures within the sensor (such as a slot).

[0095] According to one aspect of the present disclosure, a sensor is also provided, comprising the electrode assembly 100 of any of the aforementioned embodiments. The specific product type of the sensor is not limited, and may be, for example, an electrochemical biosensor or an electrochemical sensor. The electrochemical biosensor may be an implantable electrochemical biosensor for implantation in a living organism, or an in vitro electrochemical biosensor for immersion in a solution containing a target analyte. Because the electrode assembly 100 has improved manufacturing precision and reduced manufacturing difficulty compared to related technologies, the sensor has higher detection accuracy and relatively lower manufacturing costs.

[0096] As shown in Figure 6, the embodiment of the present disclosure also provides a method 600 for manufacturing an electrode device. The manufacturing method 600 can be used to manufacture the electrode device 100 of the embodiment shown in Figures 1 to 5. It can be combined with reference to Figures 1 to 6. The manufacturing method 600 includes the following steps S601 to S603.

[0097] In step S601 , a flexible substrate 20 is provided. The flexible substrate 20 includes a first plate portion 21 and a second plate portion 22 that are symmetrical with respect to a symmetry line 201 .

[0098] In step S602 , an electrode structure 40 is formed on one side of the flexible substrate 20 , wherein the electrode structure 40 includes at least one first electrode 41 located on the first plate portion 21 and at least one second electrode 42 located on the second plate portion 22 .

[0099] In step S603 , the first plate portion 21 and the second plate portion 22 are folded along the symmetry line 201 , so that a surface of the first plate portion 21 facing away from the electrode structure 40 faces a surface of the second plate portion 22 facing away from the electrode structure 40 .

[0100] The material type of the flexible substrate 20 is not limited; for example, it can include at least one of polycarbonate (PC), polyethylene terephthalate (PET), or polyimide (PI). In some embodiments, the thickness of the flexible substrate 20 ranges from 0.01 mm to 0.3 mm. For example, a medical-grade flexible substrate 20 with a thickness of 0.05 mm, 0.1 mm, or 0.2 mm can be selected. After folding along the symmetry line 201, the laminated thickness is relatively thin. The symmetry line 201 may or may not be marked on the flexible substrate 20. When the flexible substrate 20 is flattened, the first plate portion 21 and the second plate portion 22 are located on either side of the symmetry line 201 and are symmetrical about the symmetry line 201.

[0101] In the disclosed embodiment, the electrode structure 40 is fabricated as a single layer and can be patterned by one or more fabrication processes, including but not limited to screen printing, inkjet printing, and micro-electro-mechanical system (MEMS) fabrication processes. The materials of the different electrodes can be the same or different. When the different electrodes are made of different materials, the electrode structure 40 can be patterned on the flexible substrate 20 by multiple fabrication processes. In some embodiments, the electrode structure 40 includes a first working electrode 411, a second working electrode 421, a first counter electrode 412, and a second counter electrode 422. The materials of the first working electrode 411 and the second working electrode 421 can include at least one of carbon, gold, platinum, and the like, and the materials of the first counter electrode 412 and the second counter electrode 422 can include at least one of silver or silver chloride. The first working electrode 411 and the second working electrode 421 can be first formed on corresponding areas of the flexible substrate 20 by screen printing, and then the first counter electrode 412 and the second counter electrode 422 can be formed on corresponding areas of the flexible substrate 20 by screen printing.

[0102] Using the design method of the disclosed embodiment, since the electrode structure 40 is fabricated on a single surface of the flexible substrate 20, there is no need to consider the alignment of the structure on the other surface of the substrate as in the related art. Therefore, the manufacturing accuracy of the electrode device 100 can be improved and its manufacturing difficulty can be reduced. Since the electrode structure 40 is fabricated in a single layer, it is easy to meet high precision requirements. Therefore, there is no need to laminate the layers as in the related art, thereby reducing the complexity of the process and the difficulty of manufacturing. Since the manufacturing accuracy of the electrode device 100 is high and the manufacturing difficulty is relatively low, the electrode device 100 can easily realize a dual-electrode system design. Therefore, the design of the electrode device 100 of the disclosed embodiment can not only improve the performance of the electrode device 100, but also reduce its production cost.

[0103] In some embodiments of the present disclosure, the manufacturing method further includes: before folding the first plate portion 21 and the second plate portion 22 along the symmetry line 201, forming on one side of the flexible substrate 20 at least one first electrical connection portion 71 located in the first plate portion 21 and arranged in a one-to-one correspondence with the at least one first electrode 41, at least one first lead 81 located in the first plate portion 21 and correspondingly connecting the at least one first electrode 41 to the at least one first electrical connection portion 71, at least one second electrical connection portion 72 located in the second plate portion 22 and correspondingly corresponding to the at least one second electrode 42, and at least one second lead 82 located in the second plate portion 22 and correspondingly connecting the at least one second electrode 42 to the at least one second electrical connection portion 72.

[0104] When the flexible substrate 20 is in a flat state, the electrodes, electrical connections and leads can be manufactured on one side of the flexible substrate 20 first, and then the flexible substrate 20 can be folded. This not only improves the manufacturing accuracy but also simplifies the manufacturing process.

[0105] In some embodiments, the electrode device 100 adopts the aforementioned three-electrode system or two-electrode system design. The above manufacturing method may further include: before folding the first plate portion 21 and the second plate portion 22 along the symmetry line 201, performing the following method steps:

[0106] A first biosensitive substance layer 51 is formed on the side of the first working electrode 411 facing away from the first plate portion 21;

[0107] forming at least one first biofunctional layer 61 covering the plurality of first electrodes 41 and the first biosensitive substance layer 51;

[0108] forming a second biosensitive substance layer 52 on a side of the second working electrode 421 facing away from the second plate portion 22; and

[0109] At least one second bio-functional layer 62 is formed to cover the plurality of second electrodes 42 and the second bio-sensitive substance layer 52 .

[0110] The electrode assembly 100 fabricated according to the method of this embodiment can be used in electrochemical biosensors. The first biosensitive material layer 51 and the second biosensitive material layer 52 can have the same or different compositions. The first biofunctional layer 61 and the second biofunctional layer 62 can be used to improve and / or control the performance of the electrode assembly 100. Furthermore, they can also provide connection, protection, and structural reinforcement. The first and second biofunctional layers 61 and 62 can be hydrophilic polymer layers, flux-limiting layers, or anti-interference layers, among others. The number of layers and their functions can be flexibly designed and selected based on product requirements.

[0111] The first biosensitive substance layer 51 , the second biosensitive substance layer 52 , the first biofunctional layer 61 and the second biofunctional layer 62 can be formed respectively by using film-forming processes such as drop coating, dip coating, circle coating and spray coating.

[0112] The present disclosure does not limit the order of the steps of the method of this embodiment. For example, a first biosensitive material layer 51 can be formed on one side of the symmetry line 201 using a drop coating process, and each first biofunctional layer 61 can be formed using a dip coating process. Then, a second biosensitive material layer 52 can be formed on the other side of the symmetry line 201 using a drop coating process, and each second biofunctional layer 62 can be formed using a dip coating process. For example, a first biosensitive material layer 51 can be formed on one side of the symmetry line 201 using a drop coating process, and a second biosensitive material layer 52 can be formed on the other side of the symmetry line 201 using a drop coating process. Then, each first biofunctional layer 61 can be formed on one side of the symmetry line 201 using a dip coating process, and each second biofunctional layer 62 can be formed on the other side of the symmetry line 201 using a dip coating process. When formed by the dip coating process, the first biofunctional layer 61 and the second biofunctional layer 62 can be formed on both sides of the flexible substrate 20.

[0113] Since each biosensitive substance layer and each biofunctional layer is formed before the flexible substrate 20 is folded, and the films on both sides of the symmetry line 201 are spaced a certain distance apart and do not interfere with each other, the film forming process is more flexible and easy to implement.

[0114] In some embodiments of the present disclosure, the first biosensitive substance layer 51, the second biosensitive substance layer 52, the first biofunctional layer 61, and the second biofunctional layer 62 may also be formed after the flexible substrate 20 is folded. For example, after the flexible substrate 20 is folded, the first biosensitive substance layer 51 may be formed on the side of the first working electrode 411 facing away from the first plate portion 21, and then at least one first biofunctional layer 61 may be formed to cover each first electrode 41 and the first biosensitive substance layer 51. Then, the second biosensitive substance layer 52 may be formed on the side of the second working electrode 421 facing away from the second plate portion 22, and then at least one second biofunctional layer 62 may be formed to cover each second electrode 42 and the second biosensitive substance layer 52.

[0115] In some embodiments, the method for manufacturing the electrode device 100 may further include: after folding the first plate portion 21 and the second plate portion 22 along the symmetry line 201, welding or bonding a surface of the first plate portion 21 facing away from the electrode structure 40 to a surface of the second plate portion 22 facing away from the electrode structure 40. In this way, the first plate portion 21 and the second plate portion 22 can be tightly stacked and connected.

[0116] Although the embodiments or examples of the present disclosure have been described with reference to the accompanying drawings, it should be understood that the above-mentioned methods, systems and devices are merely exemplary embodiments or examples, and the scope of the present invention is not limited by these embodiments or examples, but is only limited by the claims after authorization and their equivalents. Various elements in the embodiments or examples may be omitted or replaced by their equivalents. In addition, the steps may be performed in an order different from that described in this disclosure. Further, the various elements in the embodiments or examples may be combined in various ways. It is important that as technology evolves, many of the elements described herein may be replaced by equivalent elements that appear after this disclosure.

Claims

1. An electrode device, characterized in that: The electrode device comprises: A flexible substrate, comprising a first plate portion and a second plate portion folded and overlapped along a symmetry line; and An electrode structure, the electrode structure comprising at least one first electrode and at least one second electrode, wherein the at least one first electrode is located on a side of the first plate portion facing away from the second plate portion, and the at least one second electrode is located on a side of the second plate portion facing away from the first plate portion.

2. The electrode device according to claim 1, characterized in that The at least one first electrode includes a plurality of first electrodes, and the at least one second electrode includes a plurality of second electrodes, wherein: The plurality of first electrodes include a first working electrode and a first counter electrode, and the plurality of second electrodes include a second working electrode and a second counter electrode; or The plurality of first electrodes include a first working electrode, a first counter electrode, and a first reference electrode, and the plurality of second electrodes include a second working electrode, a second counter electrode, and a second reference electrode.

3. The electrode device according to claim 1, characterized in that The at least one first electrode includes a plurality of first electrodes, and the at least one second electrode includes a plurality of second electrodes, wherein: The plurality of first electrodes include a first working electrode and a first pair of electrodes, and the plurality of second electrodes include a second working electrode aligned opposite to the first working electrode, and a second pair of electrodes aligned opposite to the first pair of electrodes; or The multiple first electrodes include a first working electrode, a first counter electrode and a first reference electrode, and the multiple second electrodes include a second working electrode aligned back to back with the first working electrode, a second counter electrode aligned back to back with the first counter electrode, and a second reference electrode aligned back to back with the first reference electrode.

4. The electrode device according to claim 2 or 3, characterized in that: The electrode device also includes: A first biosensitive material layer is located on a side of the first working electrode facing away from the first plate portion; At least one first biofunctional layer, covering the plurality of first electrodes and the first biosensitive substance layer; A second biosensitive substance layer is located on a side of the second working electrode facing away from the second plate portion; and At least one second biofunctional layer covers the plurality of second electrodes and the second biosensitive substance layer.

5. The electrode device according to claim 4, characterized in that The first biosensitive substance layer and the second biosensitive substance layer contain the same or different biosensitive substance components.

6. The electrode device according to claim 1, characterized in that The electrode device also includes: At least one first electrical connection portion, located on a side of the first plate portion facing away from the second plate portion and arranged in one-to-one correspondence with the at least one first electrode; at least one first lead, located at a side of the first plate portion facing away from the second plate portion and correspondingly connecting the at least one first electrode to the at least one first electrical connection portion; at least one second electrical connection portion, located on a side of the second plate portion facing away from the first plate portion and arranged in one-to-one correspondence with the at least one second electrode; and At least one second lead is located on a side of the second plate portion facing away from the first plate portion and connects the at least one second electrode to the at least one second electrical connection portion accordingly.

7. The electrode device according to claim 6, characterized in that The first plate portion includes a first portion extending along a first direction and a a second portion extending in a second direction intersecting therewith, wherein the at least one first electrode is disposed on the first portion, and the at least one first electrical connection portion is disposed on the second portion; The second plate portion includes a third portion extending along the first direction and a fourth portion extending along the second direction, wherein the at least one second electrode is disposed at the third portion, and the at least one second electrical connection portion is disposed at the fourth portion.

8. The electrode device according to claim 7, characterized in that The at least one first electrode comprises a plurality of first electrodes, and the at least one first electrical connection portion comprises a plurality of first electrical connection portions, wherein the plurality of first electrodes are sequentially arranged along the first direction, and the plurality of first electrical connection portions are sequentially arranged along the second direction; and / or The at least one second electrode includes a plurality of second electrodes, and the at least one second electrical connection portion includes a plurality of second electrical connection portions, wherein the plurality of second electrodes are sequentially arranged along the first direction, and the plurality of second electrical connection portions are sequentially arranged along the second direction.

9. The electrode device according to claim 7, characterized in that: The first direction is orthogonal to the second direction, and the symmetry line extends along the first direction or along the second direction.

10. The electrode device according to any one of claims 1, 2, 3, 6 to 9, characterized in that: The flexible substrate is provided with a folding notch at at least one end of the symmetry line.

11. The electrode device according to any one of claims 1, 2, 3, 6 to 9, characterized in that: A surface of the first plate portion facing the second plate portion is welded or bonded to a surface of the second plate portion facing the first plate portion.

12. The electrode device according to any one of claims 1, 2, 3, 6 to 9, characterized in that: The thickness of the flexible substrate ranges from 0.01 mm to 0.3 mm.

13. A sensor, characterized in that: The sensor comprises: An electrode device according to any one of claims 1 to 12.

14. A method for manufacturing an electrode device, characterized in that: The production method comprises: Provide a flexible substrate, the flexible substrate comprising a first plate portion and a second plate portion that are symmetrical relative to a symmetry line; forming an electrode structure on one side of the flexible substrate, wherein the electrode structure includes at least one first electrode located on the first board portion and at least one second electrode located on the second board portion; and The first plate portion and the second plate portion are folded along the symmetry line, and a side of the first plate portion facing away from the electrode structure faces a side of the second plate portion facing away from the electrode structure.

15. The manufacturing method according to claim 14, characterized in that: The manufacturing method further comprises: before folding the first plate portion and the second plate portion along the symmetry line, At least one first electrical connection portion located in the first board portion and arranged in one-to-one correspondence with the at least one first electrode, at least one first lead located in the first board portion and correspondingly connecting the at least one first electrode to the at least one first electrical connection portion, at least one second electrical connection portion located in the second board portion and arranged in one-to-one correspondence with the at least one second electrode, and at least one second lead located in the second board portion and correspondingly connecting the at least one second electrode to the at least one second electrical connection portion are formed on one side of the flexible substrate.

16. The manufacturing method according to claim 14, characterized in that: The at least one first electrode comprises a plurality of first electrodes, and the at least one second electrode comprises a plurality of second electrodes, wherein the plurality of first electrodes comprises a first working electrode and a first counter electrode, and the plurality of second electrodes comprises a second working electrode and a second counter electrode; or, the plurality of first electrodes comprises a first working electrode, a first counter electrode and a first reference electrode, and the plurality of second electrodes comprises a second working electrode, a second counter electrode and a second reference electrode; The manufacturing method further comprises: before folding the first plate portion and the second plate portion along the symmetry line, or after folding the first plate portion and the second plate portion along the symmetry line, forming a first biosensitive substance layer on a side of the first working electrode facing away from the first plate portion; forming at least one first biofunctional layer covering the plurality of first electrodes and the first biosensitive substance layer; forming a second biosensitive substance layer on a side of the second working electrode facing away from the second plate portion; and At least one second biofunctional layer is formed covering the plurality of second electrodes and the second biosensitive substance layer.

17. The manufacturing method according to claim 16, characterized in that: The first biosensitive substance layer and the second biosensitive substance layer contain the same or different biosensitive substance components.

18. The method according to any one of claims 14 to 17, characterized in that: The production method further comprises: After the first plate portion and the second plate portion are folded along the symmetry line, a side of the first plate portion facing away from the electrode structure is welded or bonded to a side of the second plate portion facing away from the electrode structure.

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