Analyte sensors based on monitoring multiple analytes

Abstract

The present invention provides an analyte sensor based on monitoring multiple analytes. The analyte sensor contains a channel structure, and the analyte sensor can be implanted in the human body to realize simultaneous monitoring of multiple analytes. The analyte sensor has the characteristics of good flexibility, small size, coexistence of multiple analysis methods, low manufacturing cost, simple process flow, and long-term monitoring. The analyte sensor has the function of simultaneous monitoring of analytes / indicators, and the analyte sensor can realize the characteristics of two functional areas in one plane at the same time. The introduction of the channel structure of the present invention makes the thickness of the analyte sensor more suitable and the wearing experience is better. At the same time, the introduction of the channel structure can avoid the problem of unstable signal transmission caused by the small area of ​​the electrode or the narrow electrode wire, resulting in poor stability of the sensor.

Description

Technical Field

[0001] The present invention belongs to the technical field of sensors, and in particular relates to an analyte sensor based on monitoring multiple analytes. Background Art

[0002] Flexible electrodes refer to electrodes made of flexible substrates. Biosensors made of flexible electrodes have the characteristics of light weight, high softness, stretchability and excellent comfort. Biosensors made of flexible electrodes are widely used in the detection of in vitro nucleic acids, proteins, glucose, bacteria, toxins, cells and pesticides.

[0003] At present, most flexible electrodes are used for temporary in vitro detection. With the increasing demand, people are increasingly in need of sensors that can continuously monitor analytes in the body. However, the current flexible electrodes are large in size and cannot meet the human body's adaptability to sensors. At the same time, the complex manufacturing process and high manufacturing cost of sensors further limit the development of analyte sensors. Summary of the invention

[0004] In order to improve the deficiencies of the prior art, the present invention provides an analyte sensor based on monitoring multiple analytes. The analyte sensor can realize simultaneous monitoring of multiple analytes after being implanted in the human body. The analyte sensor has the characteristics of good flexibility, small size, coexistence of multiple analysis methods, low manufacturing cost, simple process flow, and long-term monitoring.

[0005] The object of the present invention is achieved through the following technical solutions:

[0006] An analyte sensor comprises a substrate, a first working electrode, a second working electrode, a reference electrode, a counter electrode, a first sensing layer and a second sensing layer; the first sensing layer is arranged on the first working electrode, and the second sensing layer is arranged on the second working electrode; any two electrodes of the first working electrode, the second working electrode, the reference electrode and the counter electrode are located on the first surface of the substrate, and the remaining two electrodes of the first working electrode, the second working electrode, the reference electrode and the counter electrode are located on the second surface of the substrate opposite to the first surface; the two electrodes located on the first surface of the substrate are spatially separated by a channel, and / or the two electrodes located on the second surface of the substrate opposite to the first surface are spatially separated by a channel; the width of the channel is 1μm-280μm; the length of the channel is 30μm-10000μm.

[0007] An analyte sensor comprises a substrate, a first working electrode, a second working electrode, a reference electrode, a counter electrode, a first sensing layer and a second sensing layer; the first sensing layer is arranged on the first working electrode, and the second sensing layer is arranged on the second working electrode; any three electrodes among the first working electrode, the second working electrode, the reference electrode and the counter electrode are located on the first surface of the substrate, and the remaining electrode among the first working electrode, the second working electrode, the reference electrode and the counter electrode are located on the second surface of the substrate opposite to the first surface; one electrode among the three electrodes located on the first surface of the substrate is arranged on the surface of the substrate, and the remaining two electrodes among the three electrodes are respectively stacked and arranged on the surface of the one electrode and separated by a dielectric layer, and the remaining two electrodes among the three electrodes are spatially separated by a channel; the width of the channel is 1μm-280μm; the length of the channel is 30μm-10000μm.

[0008] Beneficial effects of the present invention:

[0009] The present invention provides an analyte sensor based on monitoring multiple analytes. The analyte sensor contains a channel structure. The analyte sensor can be implanted in the human body to realize simultaneous monitoring of multiple analytes. The analyte sensor has the characteristics of good flexibility, small size, coexistence of multiple analysis methods, low production cost, simple process flow, and long-term monitoring. The analyte sensor has the function of simultaneous monitoring of analytes / indicators, the analyte sensor has the function of coexistence of multiple analysis methods, the analyte sensor has the function of implantation, continuous monitoring, low production cost, simple process flow, small size, and good flexibility; the analyte sensor can realize the characteristics of 2 functional areas in one plane at the same time. The introduction of the channel structure of the present invention makes the thickness of the analyte sensor more suitable and the wearing experience is better. At the same time, the introduction of the channel structure can avoid the problem of unstable signal transmission caused by the small area of ​​the electrode or the narrow electrode wire, resulting in poor stability of the sensor. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] Figure 1 2 is a view of the sensor electrode structure A of Example 1.

[0011] Figure 2 Schematic diagram of the structure of the AA' section of the sensor electrode structure A of Example 1.

[0012] Figure 3 Schematic diagram of the structure of the BB' section of the sensor electrode structure A of Example 1.

[0013] Figure 4 Schematic diagram of the structure of the CC' section of the sensor electrode structure A of Example 1.

[0014] Figure 5 This is a view of sensor electrode structure B of Example 2.

[0015] Figure 6 Schematic diagram of the structure of the AA' section of the sensor electrode structure B of Example 2.

[0016] Figure 7 Schematic diagram of the structure of the BB' section of the sensor electrode structure B of Example 2.

[0017] Figure 8 Schematic diagram of the structure of the CC' section of the sensor electrode structure B of Example 2.

[0018] Fig. 9 3 is a view of a sensor electrode structure C of Example 3.

[0019] Fig.10 Schematic diagram of the structure of the AA' section of the sensor electrode structure C of Example 3.

[0020] Fig.11 Schematic diagram of the structure of the BB' section of the sensor electrode structure C of Example 3.

[0021] Fig.12 Schematic diagram of the structure of the CC' section of the sensor electrode structure C of Example 3.

[0022] Fig.13 This is a view of a sensor electrode structure D of Example 4.

[0023] Fig.14 Schematic diagram of the structure of the AA' section of the sensor electrode structure D of Example 4.

[0024] Fig.15 Schematic diagram of the structure of the BB' section of the sensor electrode structure D of Example 4.

[0025] Fig.16 Schematic diagram of the structure of the CC' section of the sensor electrode structure D of Example 4.

[0026] Fig.17 This is a view of the sensor electrode structure E of Example 5.

[0027] Fig.18 Schematic diagram of the structure of the AA' section of the sensor electrode structure E of Example 5.

[0028] Fig.19 Schematic diagram of the structure of the BB' section of the sensor electrode structure E of Example 5.

[0029] Fig. 20Schematic diagram of the structure of the CC' section of the sensor electrode structure E of Example 5.

[0030] Fig.21 This is a view of the sensor electrode structure F of Example 6.

[0031] Fig. 22 Schematic diagram of the structure of the AA' section of the sensor electrode structure F of Example 6.

[0032] Fig.23 Schematic diagram of the structure of the BB' section of the sensor electrode structure F of Example 6.

[0033] Fig.24 Schematic diagram of the structure of the CC' section of the sensor electrode structure F of Example 6.

[0034] Fig.25 This is a view of the sensor electrode structure G of Example 7.

[0035] Fig.26 Schematic diagram of the structure of the AA' section of the sensor electrode structure G of Example 7.

[0036] Fig. 27 Schematic diagram of the structure of the BB' section of the sensor electrode structure G of Example 7.

[0037] Fig.28 Schematic diagram of the structure of the CC' section of the sensor electrode structure G of Example 7.

[0038] Fig.29 3 is a view of a sensor electrode structure H of Example 8.

[0039] Fig.30 Schematic diagram of the structure of the AA' section of the sensor electrode structure H of Example 8.

[0040] Fig.31 Schematic diagram of the structure of the BB' section of the sensor electrode structure H of Example 8.

[0041] Fig.32 Schematic diagram of the structure of the CC' section of the sensor electrode structure H of Example 8.

[0042] Fig.33 A view of the sensor electrode structure I of Example 9.

[0043] Fig.34 Schematic diagram of the structure of the AA' section of the sensor electrode structure I of Example 9.

[0044] Fig.35 Schematic diagram of the structure of the BB' section of the sensor electrode structure I of Example 9.

[0045] Fig.36 Schematic diagram of the structure of the CC' section of the sensor electrode structure I of Example 9.

[0046] Fig.37 A partial view of the protrusion position of the sensor of the present invention.

[0047] Fig.38 The diagrams are a schematic diagram of a sensor with a protruding structure and an auxiliary device in combination (left figure) and a schematic diagram of a sensor without a protruding structure and an auxiliary device in combination (right figure), wherein reference numeral 1000 is an auxiliary device and 1001 is a sensor.

[0048] Fig.39 Schematic diagram of the structure of the sensor surface after the sensor with a protrusion structure is implanted into the human body (left figure) and the schematic diagram of the structure of the sensor surface after the sensor without a protrusion structure is implanted into the human body (right figure).

[0049] Fig.40 Schematic diagram of the structure of the sensor after implanting a sensor with a channel structure into a human body (left figure) and schematic diagram of the structure of the sensor after implanting a sensor without a channel structure (i.e., a stacked structure) into a human body (right figure).

[0050] Fig.41 This is a partially enlarged view of the sensor described in the preferred embodiment of the present invention.

[0051] Fig.42 This is a graph showing the changing trend of blood sugar monitored by the first working electrode after the sensor electrode structure of Comparative Example 1 is implanted in a human body for one day.

[0052] Fig.43 This is a graph showing the changing trend of blood sugar monitored by the first working electrode after the sensor electrode structure of Comparative Example 2 was implanted in the human body for 4 days. DETAILED DESCRIPTION

[0053] <Analyte Sensor>

[0054] As mentioned above, the present invention provides an analyte sensor, the analyte sensor comprising a substrate 100, a first working electrode, a second working electrode, a reference electrode, a counter electrode, a first sensing layer 115 and a second sensing layer 122; the first sensing layer 115 is disposed on the first working electrode, and the second sensing layer 122 is disposed on the second working electrode;

[0055] Any two of the first working electrode, the second working electrode, the reference electrode and the counter electrode are located on a first surface of the substrate, and the remaining two of the first working electrode, the second working electrode, the reference electrode and the counter electrode are located on a second surface of the substrate opposite to the first surface;

[0056] Two electrodes located on a first surface of the substrate are spatially separated by a channel, and / or two electrodes located on a second surface of the substrate opposite to the first surface are spatially separated by a channel;

[0057] The width of the channel is 1 μm-280 μm; the length of the channel is 30 μm-10000 μm.

[0058] According to an embodiment of the present invention, any two of the first working electrode, the second working electrode, the reference electrode and the counter electrode are located on the first surface of the substrate, and the remaining two of the first working electrode, the second working electrode, the reference electrode and the counter electrode are located on the second surface of the substrate opposite to the first surface; the two electrodes located on the first surface of the substrate are spatially separated by a channel, and / or the two electrodes located on the second surface of the substrate opposite to the first surface are spatially separated by a channel; such a structural arrangement enables the first surface of the sensor to have two functional areas / electrode areas with different functions, and / or the second surface of the sensor opposite to the first surface to have two functional areas / electrode areas with different functions, and the two functional areas / electrode areas Different functional areas / electrode areas are separated in space by channels and will not affect each other, which makes it possible to realize the functions of two functional areas / electrode areas with different functions on the same side surface of the sensor, effectively reducing the risk of sensor failure due to contact between the two functional areas / electrode areas with different functions; and such a structural setting can ensure that the functional area / electrode area of ​​the sensor has sufficient area, so that the sensor has good stability during long-term monitoring, and can effectively avoid short circuit and open circuit problems caused by the small area of ​​each electrode itself and the narrow electrode wire when the first working electrode, the second working electrode, the reference electrode and the counter electrode are arranged on the same surface due to the limited implantation width of the sensor itself. In addition, the structural setting of the two functional areas / electrode areas with different functions located on the same side surface of the sensor makes the preparation process of the sensor relatively simple, especially compared with the sensor designed according to the stacking structure (that is, any two electrodes are in a vertical relationship in space, and then separated by a dielectric layer in the middle; this stacking structure increases the process and difficulty of the sensor, and the thickness will be thicker, affecting the wearing experience); the structural setting of the two functional areas / electrode areas with different functions on the same side surface of the sensor also ensures that the obtained sensor has good flexibility, small size, low cost, and better wearing comfort; and due to the setting of the reference electrode, the analyte sensor can monitor the analyte for a long time after being implanted in the body.

[0059] According to an embodiment of the present invention, the first working electrode, the second working electrode, the reference electrode and the counter electrode are respectively arranged on both sides of the substrate, forming a structure in which the first surface of the substrate is provided with two electrodes, and the second surface of the substrate opposite to the first surface is provided with two electrodes; wherein the two electrodes arranged on the first surface of the substrate refer to any two of the first working electrode, the second working electrode, the reference electrode and the counter electrode; the two electrodes arranged on the second surface of the substrate opposite to the first surface refer to the remaining two electrodes except the above-mentioned two electrodes.

[0060] According to an embodiment of the present invention, the first working electrode and the reference electrode are arranged on the first surface of the substrate, and the counter electrode and the second working electrode are arranged on the second surface of the substrate opposite to the first surface; or the first working electrode and the counter electrode are arranged on the first surface of the substrate, and the reference electrode and the second working electrode are arranged on the second surface of the substrate opposite to the first surface; or the counter electrode and the reference electrode are arranged on the first surface of the substrate, and the first working electrode and the second working electrode are arranged on the second surface of the substrate opposite to the first surface.

[0061] According to an embodiment of the present invention, the first working electrode and the reference electrode are arranged on a first surface of the substrate, the counter electrode and the second working electrode are arranged on a second surface of the substrate opposite to the first surface, the first working electrode and the reference electrode are spatially separated by a channel, and / or the counter electrode and the second working electrode are spatially separated by a channel; or,

[0062] The first working electrode and the counter electrode are arranged on a first surface of the substrate, the reference electrode and the second working electrode are arranged on a second surface of the substrate opposite to the first surface, the first working electrode and the counter electrode are spatially separated by a channel, and / or the reference electrode and the second working electrode are spatially separated by a channel; or,

[0063] The counter electrode and the reference electrode are arranged on the first surface of the substrate, the first working electrode and the second working electrode are arranged on the second surface of the substrate opposite to the first surface, the counter electrode and the reference electrode are spatially separated by a channel, and / or the first working electrode and the second working electrode are spatially separated by a channel.

[0064] According to an embodiment of the present invention, a first working electrode and a reference electrode are arranged on a first surface of a substrate, and a counter electrode and a second working electrode are arranged on a second surface of the substrate opposite to the first surface; wherein the first working electrode and the reference electrode are spatially separated by a channel, and the counter electrode and the second working electrode are spatially separated by a channel; or, the first working electrode and the reference electrode are spatially separated by a channel, and the counter electrode and the second working electrode are stacked on each other and arranged on the second surface of the substrate opposite to the first surface and separated by a dielectric layer; or, the first working electrode and the reference electrode are stacked on each other and arranged on the first surface of the substrate and separated by a dielectric layer, and the counter electrode and the second working electrode are spatially separated by a channel.

[0065] According to an embodiment of the present invention, a first working electrode and a counter electrode are arranged on a first surface of a substrate, and a reference electrode and a second working electrode are arranged on a second surface of the substrate opposite to the first surface; wherein the first working electrode and the counter electrode are spatially separated by a channel, and the reference electrode and the second working electrode are spatially separated by a channel; or, the first working electrode and the counter electrode are spatially separated by a channel, and the reference electrode and the second working electrode are stacked on each other and arranged on the second surface of the substrate opposite to the first surface and separated by a dielectric layer; or, the first working electrode and the counter electrode are stacked on each other and arranged on the first surface of the substrate and separated by a dielectric layer, and the reference electrode and the second working electrode are spatially separated by a channel.

[0066] According to an embodiment of the present invention, the counter electrode and the reference electrode are arranged on the first surface of the substrate, and the first working electrode and the second working electrode are arranged on the second surface of the substrate opposite to the first surface; wherein the counter electrode and the reference electrode are spatially separated by a channel, and the first working electrode and the second working electrode are spatially separated by a channel; or, the counter electrode and the reference electrode are spatially separated by a channel, and the first working electrode and the second working electrode are stacked on each other and arranged on the second surface of the substrate opposite to the first surface and separated by a dielectric layer; or, the counter electrode and the reference electrode are stacked on each other and arranged on the first surface of the substrate and separated by a dielectric layer, and the first working electrode and the second working electrode are spatially separated by a channel.

[0067] According to an embodiment of the present invention, two electrodes located on the same side of the substrate and separated in space by a trench are completely located on the same plane; illustratively, electrode layers, electrode wires and electrode contacts of the two electrodes are all located on the same plane.

[0068] According to an embodiment of the present invention, two electrode portions located on the same side of the substrate and spatially separated by a channel are located on the same plane; illustratively, the electrode layers of the two electrodes are not located on the same plane, but the electrode wires and electrode contacts of the two electrodes are located on the same plane; or, the electrode wires of the two electrodes are not located on the same plane, but the electrode layers and electrode contacts of the two electrodes are located on the same plane; or, the electrode contacts of the two electrodes are not located on the same plane, but the electrode wires and electrode layers of the two electrodes are located on the same plane; or, the electrode layers and electrode contacts of the two electrodes are not located on the same plane, but the electrode wires of the two electrodes are located on the same plane; or, the electrode wires and electrode contacts of the two electrodes are not located on the same plane, but the electrode layers of the two electrodes are located on the same plane; or, the electrode wires and electrode layers of the two electrodes are not located on the same plane, but the electrode contacts of the two electrodes are located on the same plane.

[0069] According to an embodiment of the present invention, two electrodes stacked on each other on the same side of the substrate are not located on the same plane and are separated by a dielectric layer; illustratively, the electrode layers, electrode wires and electrode contacts of the two electrodes are not located on the same plane and are separated by a dielectric layer.

[0070] According to an embodiment of the present invention, two electrodes located on the same side of the substrate and spatially separated by a trench are not stacked on each other.

[0071] <Analyte Sensor>

[0072] The present invention provides an analyte sensor, the analyte sensor comprising a substrate, a first working electrode, a second working electrode, a reference electrode, a counter electrode, a first sensing layer 115 and a second sensing layer 122; the first sensing layer 115 is disposed on the first working electrode, and the second sensing layer 122 is disposed on the second working electrode;

[0073] Any three electrodes among the first working electrode, the second working electrode, the reference electrode and the counter electrode are located on the first surface of the substrate, and the remaining electrode among the first working electrode, the second working electrode, the reference electrode and the counter electrode is located on the second surface of the substrate opposite to the first surface;

[0074] One of the three electrodes located on the first surface of the substrate is disposed on the surface of the substrate, and the remaining two of the three electrodes are stacked and disposed on the surface of the one electrode and separated by a dielectric layer, and the remaining two of the three electrodes are spatially separated by a channel;

[0075] The width of the channel is 1 μm-280 μm; the length of the channel is 30 μm-10000 μm.

[0076] According to an embodiment of the present invention, any three electrodes among the first working electrode, the second working electrode, the reference electrode and the counter electrode are located on the first surface of the substrate, the remaining electrode among the first working electrode, the second working electrode, the reference electrode and the counter electrode is located on the second surface of the substrate opposite to the first surface, one electrode among the three electrodes located on the first surface of the substrate is arranged on the surface of the substrate, the remaining two electrodes among the three electrodes are respectively stacked on the surface of the one electrode and separated by a dielectric layer, and the remaining two electrodes among the three electrodes are spatially separated by a channel; such a structural arrangement enables the first surface of the sensor to have three functional areas / electrode areas with different functions, and the second surface of the sensor opposite to the first surface to have a functional area Domain / electrode area, and functional areas / electrode areas with different functions are separated in space by channels and will not affect each other, which makes it possible to realize the functions of functional areas / electrode areas with different functions on the same side surface of the sensor, effectively reducing the risk of sensor failure due to contact between functional areas / electrode areas with different functions; and such a structural setting can ensure that the functional area / electrode area of ​​the sensor has sufficient area, so that the sensor has good stability during long-term monitoring, and can effectively avoid the problems of short circuit and open circuit caused by the small area of ​​each electrode itself and the narrow electrode wire when the first working electrode, the second working electrode, the reference electrode and the counter electrode are arranged on the same surface due to the limited implantation width of the sensor itself. In addition, the structural setting of the functional areas / electrode areas with different functions located on the same side surface of the sensor makes the preparation process of the sensor relatively simple, especially compared with the sensor designed according to the stacking structure (that is, any three electrodes are in a vertical relationship in space and then separated by a dielectric layer; this stacking structure increases the process and difficulty of the sensor, and the thickness will be thicker, affecting the wearing experience); the structural setting of the functional areas / electrode areas with different functions on the same side surface of the sensor also ensures that the obtained sensor has good flexibility, small size, low cost, and better wearing comfort; and due to the setting of the reference electrode, the analyte sensor can monitor the analyte for a long time after being implanted in the body.

[0077] According to an embodiment of the present invention, the first working electrode, the second working electrode, the reference electrode and the counter electrode are respectively arranged on both sides of the substrate, forming a structure in which three electrodes are arranged on the first surface of the substrate, and one electrode is arranged on the second surface of the substrate opposite to the first surface; wherein the three electrodes arranged on the first surface of the substrate refer to any three of the first working electrode, the second working electrode, the reference electrode and the counter electrode; and the one electrode arranged on the second surface of the substrate opposite to the first surface refers to the remaining one electrode except the above three electrodes.

[0078] According to an embodiment of the present invention, the first working electrode, the second working electrode and the reference electrode are arranged on the first surface of the substrate, and the counter electrode is arranged on the second surface of the substrate opposite to the first surface; or, the first working electrode, the second working electrode and the counter electrode are arranged on the first surface of the substrate, and the reference electrode is arranged on the second surface of the substrate opposite to the first surface; or, the first working electrode, the counter electrode and the reference electrode are arranged on the first surface of the substrate, and the second working electrode is arranged on the second surface of the substrate opposite to the first surface; or, the second working electrode, the counter electrode and the reference electrode are arranged on the first surface of the substrate, and the first working electrode is arranged on the second surface of the substrate opposite to the first surface.

[0079] According to an embodiment of the present invention, a first working electrode, a second working electrode and a reference electrode are arranged on a first surface of a substrate, and a counter electrode is arranged on a second surface of the substrate opposite to the first surface; wherein, the first working electrode is arranged on the surface of the substrate, the second working electrode and the reference electrode are respectively stacked and arranged on the surface of the first working electrode and separated by a dielectric layer, and the second working electrode and the reference electrode are spatially separated by a channel, and further preferably, the first working electrode is closer to the front end 101 of the substrate than the second working electrode and the reference electrode; or, the second working electrode is arranged on the surface of the substrate, the first working electrode and the reference electrode are respectively stacked and arranged on the surface of the second working electrode and separated by a dielectric layer, and the first working electrode and the reference electrode are spatially separated by a channel, and further preferably, the second working electrode is closer to the front end 101 of the substrate than the first working electrode and the reference electrode; or, the reference electrode is arranged on the surface of the substrate, the first working electrode and the second working electrode are respectively stacked and arranged on the surface of the reference electrode and separated by a dielectric layer, and the first working electrode and the second working electrode are spatially separated by a channel, and further preferably, the reference electrode is closer to the front end 101 of the substrate than the first working electrode and the second working electrode.

[0080] According to an embodiment of the present invention, a first working electrode, a second working electrode and a counter electrode are arranged on a first surface of a substrate, and a reference electrode is arranged on a second surface of the substrate opposite to the first surface; wherein, the first working electrode is arranged on the surface of the substrate, the second working electrode and the counter electrode are respectively stacked and arranged on the surface of the first working electrode and separated by a dielectric layer, the second working electrode and the counter electrode are spatially separated by a channel, and further preferably, the first working electrode is closer to the front end 101 of the substrate than the second working electrode and the counter electrode; or, the second working electrode is arranged on the surface of the substrate, the first working electrode and the counter electrode are respectively stacked and arranged on the surface of the second working electrode and separated by a dielectric layer, the first working electrode and the counter electrode are spatially separated by a channel, and further preferably, the second working electrode is closer to the front end 101 of the substrate than the first working electrode and the counter electrode; or, the counter electrode is arranged on the surface of the substrate, the first working electrode and the second working electrode are respectively stacked and arranged on the surface of the counter electrode and separated by a dielectric layer, the first working electrode and the second working electrode are spatially separated by a channel, and further preferably, the counter electrode is closer to the front end 101 of the substrate than the first working electrode and the second working electrode.

[0081] According to an embodiment of the present invention, a first working electrode, a reference electrode and a counter electrode are arranged on a first surface of a substrate, and a second working electrode is arranged on a second surface of the substrate opposite to the first surface; wherein, the first working electrode is arranged on the surface of the substrate, the reference electrode and the counter electrode are respectively stacked and arranged on the surface of the first working electrode and separated by a dielectric layer, the reference electrode and the counter electrode are spatially separated by a channel, and further preferably, the first working electrode is closer to the front end 101 of the substrate than the counter electrode and the reference electrode; or, the reference electrode is arranged on the surface of the substrate, the first working electrode and the counter electrode are respectively stacked and arranged on the surface of the reference electrode and separated by a dielectric layer, the first working electrode and the counter electrode are spatially separated by a channel, and further preferably, the reference electrode is closer to the front end 101 of the substrate than the first working electrode and the counter electrode; or, the counter electrode is arranged on the surface of the substrate, the first working electrode and the reference electrode are respectively stacked and arranged on the surface of the counter electrode and separated by a dielectric layer, the first working electrode and the reference electrode are spatially separated by a channel, and further preferably, the counter electrode is closer to the front end 101 of the substrate than the first working electrode and the reference working electrode.

[0082] According to an embodiment of the present invention, a second working electrode, a reference electrode and a counter electrode are arranged on a first surface of a substrate, and the first working electrode is arranged on a second surface of the substrate opposite to the first surface; wherein the second working electrode is arranged on the surface of the substrate, the reference electrode and the counter electrode are respectively stacked and arranged on the surface of the second working electrode and separated by a dielectric layer, the reference electrode and the counter electrode are spatially separated by a channel, and further preferably, the second working electrode is closer to the front end 101 of the substrate than the reference electrode and the counter electrode; or, the reference electrode is arranged on the surface of the substrate, the second working electrode and the counter electrode are respectively stacked and arranged on the surface of the reference electrode and separated by a dielectric layer, the second working electrode and the counter electrode are spatially separated by a channel, and further preferably, the reference electrode is closer to the front end 101 of the substrate than the counter electrode and the second working electrode; or, the counter electrode is arranged on the surface of the substrate, the second working electrode and the reference electrode are respectively stacked and arranged on the surface of the counter electrode and separated by a dielectric layer, the second working electrode and the reference electrode are spatially separated by a channel, and further preferably, the counter electrode is closer to the front end 101 of the substrate than the reference electrode and the second working electrode.

[0083] According to an embodiment of the present invention, any two electrodes of the three electrodes spatially separated by channels located on the same side of the substrate may be completely located on the same plane; illustratively, the electrode layers, electrode wires and electrode contacts of any two electrodes are all located on the same plane.

[0084] According to an embodiment of the present invention, any two electrodes of the three electrodes spatially separated by channels located on the same side of the substrate may be partially located on the same plane; illustratively, the electrode layers of any two electrodes are not located on the same plane, but the electrode wires and electrode contacts of the any two electrodes are located on the same plane; or the electrode wires of any two electrodes are not located on the same plane, but the electrode layers and electrode contacts of the any two electrodes are located on the same plane; or the electrode contacts of any two electrodes are not located on the same plane, but the electrode wires and electrode layers of the any two electrodes are located on the same plane; or the electrode layers and electrode contacts of any two electrodes are not located on the same plane, but the electrode wires of the any two electrodes are located on the same plane; or the electrode wires and electrode contacts of any two electrodes are not located on the same plane, but the electrode layers of the any two electrodes are located on the same plane; or the electrode wires and electrode layers of any two electrodes are not located on the same plane, but the electrode contacts of the two electrodes are located on the same plane.

[0085] According to an embodiment of the present invention, any two electrodes located on the same side of the substrate and spatially separated by a trench are not stacked on each other.

[0086] <Structure and composition of substrate>

[0087] According to an embodiment of the present invention, the substrate 100 includes a front end 101, a middle end 102 and a terminal end 103, and the front end 101, the middle end 102 and the terminal end 103 are sequentially connected and arranged.

[0088] According to an embodiment of the present invention, the substrate 100 has an L-shape, the L-shape includes a first side and a second side, and the connection between the first side and the second side forms an angle, and the angle is 45°-135°, preferably 88°-98°, such as 90°, 92°, 93°, 94°, 95°, 96°, 97° or 98°.

[0089] According to an embodiment of the present invention, the front end 101 is located on the first side and at the non-connected end of the first side, the end 103 is located on the second side and at the non-connected end of the second side, and the middle end 102 is located on the first side and the second side and at the connected end of the first side and the connected end of the second side. The connected end refers to the end close to the connection between the first side and the second side, and the non-connected end refers to the end away from the connection between the first side and the second side.

[0090] According to an embodiment of the present invention, the material forming the substrate includes at least one of plastic (such as polyethylene terephthalate PET, polyimide PI, polyvinyl chloride PVC or polyethylene PE), polydimethylsiloxane PDMS, ceramics, glass, paper and textiles.

[0091] According to an embodiment of the present invention, the length of the second side of the L-shaped substrate is 1mm-40mm, the length of the first side of the L-shaped substrate is 0.05mm-20mm, and the thickness of the substrate is 20μm-5000μm; preferably, the length of the second side of the L-shaped substrate is 2mm-30mm, the length of the first side of the L-shaped substrate is 0.10mm-10mm, and the thickness of the substrate is 50μm-2000μm; exemplarily, the length of the second side of the L-shaped substrate is 3mm, 4mm, 5mm, 8mm, 10mm, 12mm, 15mm, 18mm, 20mm, 25mm, 28mm or 30mm; the length of the first side of the L-shaped substrate is 0.10mm, 0.5mm, 1mm, 2mm, 3mm, 4mm, 5mm, 6mm, 8mm or 10mm.

[0092] <Structure and composition of working electrode>

[0093] According to an embodiment of the present invention, the first working electrode includes a first working electrode layer 107 , a first working electrode wire 108 and a first working electrode contact 109 , and the first working electrode layer 107 is connected to the first working electrode contact 109 via the first working electrode wire 108 .

[0094] Exemplarily, the first working electrode layer 107 is located at the front end 101 of the substrate, the first working electrode wire 108 is located at the middle end 102 of the substrate, and the first working electrode contact 109 is located at the end 103 of the substrate; or, the first working electrode layer 107 and the first working electrode wire 108 are located at the middle end 102 of the substrate, and the first working electrode contact 109 is located at the end 103 of the substrate.

[0095] According to an embodiment of the present invention, a first sensing layer 115 is disposed on the first working electrode layer 107 , and the first working electrode mainly plays a role of reacting with the first analyte.

[0096] According to an embodiment of the present invention, the second working electrode includes a second working electrode layer 119 , a second working electrode wire 120 and a second working electrode contact 121 , and the second working electrode layer 119 is connected to the second working electrode contact 121 via the second working electrode wire 120 .

[0097] Exemplarily, the second working electrode layer 119 is located at the front end 101 of the substrate, the second working electrode wire 120 is located at the middle end 102 of the substrate, and the second working electrode contact 121 is located at the end 103 of the substrate; or, the second working electrode layer 119 and the second working electrode wire 120 are located at the middle end 102 of the substrate, and the second working electrode contact 121 is located at the end 103 of the substrate.

[0098] According to an embodiment of the present invention, a second sensing layer 122 is disposed on the second working electrode layer 119 , and the second working electrode mainly plays a role in reacting with a second analyte.

[0099] According to an embodiment of the present invention, the material forming the working electrode includes one or more of carbon, gold, silver, copper and their composite materials; or, the material forming the working electrode includes one or more of noble metals, transition metals, transition metal oxides and transition metal hydroxides having catalytic / signal conversion effects. Exemplarily, the noble metals include gold and its composite materials, platinum and its composite materials; the transition metals include copper and its composite materials, nickel and its composite materials, cobalt and its composite materials, zinc and its composite materials, manganese and its composite materials, etc.

[0100] According to an embodiment of the present invention, the working electrode is modified onto the substrate by process methods including but not limited to printing, inkjet printing, electrohydrogen jet printing (EHD), dispensing, spraying, chemical vapor deposition (CVD), physical vapor deposition (PVD), magnetron sputtering, molecular beam epitaxy, electrochemical deposition, electroplating and evaporation.

[0101] According to an embodiment of the present invention, the material forming the first working electrode and the material forming the second working electrode are the same or different.

[0102] According to an embodiment of the present invention, the method for preparing the first working electrode and the method for preparing the second working electrode are the same or different.

[0103] According to an embodiment of the present invention, the thickness of the first working electrode layer is 1 μm-20 μm, preferably 5 μm-15 μm, for example, 2 μm, 3 μm, 4 μm, 5 μm, 6 μm, 7 μm, 8 μm, 9 μm, 10 μm, 11 μm, 12 μm, 15 μm or 18 μm.

[0104] According to an embodiment of the present invention, the thickness of the second working electrode layer is 1 μm-20 μm, preferably 5 μm-15 μm, for example, 2 μm, 3 μm, 4 μm, 5 μm, 6 μm, 7 μm, 8 μm, 9 μm, 10 μm, 11 μm, 12 μm, 15 μm or 18 μm.

[0105] According to an embodiment of the present invention, the thickness of the first working electrode layer and the thickness of the second working electrode layer are the same or different.

[0106] <Structure and composition of reference electrode>

[0107] According to an embodiment of the present invention, the reference electrode includes a reference electrode layer 113 , a reference electrode wire 110 and a reference electrode contact 112 , wherein the reference electrode layer 113 is disposed on the reference electrode wire 110 , and the reference electrode wire 110 is connected to the reference electrode contact 112 .

[0108] Exemplarily, the reference electrode layer 113 is located at the front end 101 of the substrate, the reference electrode wire 110 is located at the front end 101 and the middle end 102 of the substrate, and the reference electrode contact 112 is located at the end 103 of the substrate; alternatively, the reference electrode layer 113 and the reference electrode wire 110 are located at the middle end 102 of the substrate, and the reference electrode contact 112 is located at the end 103 of the substrate.

[0109] According to an embodiment of the present invention, the reference electrode forms a voltage loop with the first working electrode to provide a guarantee for converting the first analyte signal into an electrochemical signal, and forms a voltage loop with the second working electrode to provide a guarantee for converting the second analyte signal into an electrochemical signal. The reference electrode plays a role in stabilizing the potential, and thus the analyte sensor has the function and role of continuous and stable monitoring.

[0110] According to an embodiment of the present invention, the material forming the reference electrode includes Ag and AgCl, wherein the mass ratio of the Ag to the AgCl is 1:10-10:1, preferably 2:8-8:2, for example, 3:7, 4:6, 5:5, 6:4, 7:3.

[0111] According to an embodiment of the present invention, the reference electrode is modified onto the substrate by process methods including but not limited to printing, inkjet printing, electrohydrogen jet printing (EHD), dispensing, spraying, chemical vapor deposition (CVD), physical vapor deposition (PVD), magnetron sputtering, molecular beam epitaxy, electrochemical deposition, electroplating and evaporation.

[0112] According to an embodiment of the present invention, the thickness of the reference electrode layer is 0.1μm-500μm, preferably 1μm-200μm, such as 5μm, 10μm, 15μm, 20μm, 50μm, 80μm, 90μm, 100μm, 120μm, 150μm, 180μm or 200μm.

[0113] <Structure and composition of counter electrode>

[0114] According to an embodiment of the present invention, the counter electrode includes a counter electrode layer 104 , a counter electrode wire 105 and a counter electrode contact 106 , and the counter electrode layer 104 is connected to the counter electrode contact 106 via the counter electrode wire 105 .

[0115] Exemplarily, the counter electrode layer 104 is located at the front end 101 of the substrate, the counter electrode wire 105 is located at the middle end 102 of the substrate, and the counter electrode contact 106 is located at the end 103 of the substrate; or, the counter electrode layer 104 and the counter electrode wire 105 are located at the middle end 102 of the substrate, and the counter electrode contact 106 is located at the end 103 of the substrate.

[0116] According to an embodiment of the present invention, the function of the counter electrode is to form a current closed loop with the first working electrode to provide a guarantee for converting the first analyte signal into an electrochemical signal, and at the same time form a current closed loop with the second working electrode to provide a guarantee for converting the second analyte signal into an electrochemical signal.

[0117] According to an embodiment of the present invention, the material forming the counter electrode includes one or more of carbon, gold, silver, copper and composite materials thereof.

[0118] According to an embodiment of the present invention, the electrode is modified onto the substrate by process methods including but not limited to printing, inkjet printing, electrohydrogen jet printing (EHD), dispensing, spraying, chemical vapor deposition (CVD), physical vapor deposition (PVD), magnetron sputtering, molecular beam epitaxy, electrochemical deposition, electroplating and evaporation.

[0119] According to an embodiment of the present invention, the thickness of the counter electrode layer is 1 μm-20 μm, preferably 5 μm-15 μm, for example, 2 μm, 3 μm, 4 μm, 5 μm, 6 μm, 7 μm, 8 μm, 9 μm, 10 μm, 11 μm, 12 μm, 15 μm or 18 μm.

[0120] <Sensing Layer>

[0121] According to an embodiment of the present invention, the first sensing layer 115 and the second sensing layer 122 are the same or different. In order to detect different analytes, the first sensing layer 115 and the second sensing layer 122 are preferably different.

[0122] According to an embodiment of the present invention, the first sensing layer 115 is disposed on the first working electrode layer 107 of the first working electrode; and the second sensing layer 122 is disposed on the second working electrode layer 119 of the second working electrode.

[0123] According to an embodiment of the present invention, the material forming the sensing layer includes one or more of biological enzymes, precious metals, transition metals, transition metal oxides and transition metal hydroxides. Exemplarily, the biological enzymes include glucose oxidase, glucose dehydrogenase, uricase, lactase, β-hydroxybutyrate dehydrogenase, etc.; the precious metals include gold and its composite materials, platinum and its composite materials; the transition metals include copper and its composite materials, nickel and its composite materials, cobalt and its composite materials, osmium and its composite materials, zinc and its composite materials, manganese and its composite materials, iron and its composite materials, etc.

[0124] According to an embodiment of the present invention, the first sensing layer 115 is formed on the first working electrode layer of the first working electrode by processes including but not limited to adsorption, printing, inkjet printing, electrohydrodynamic printing (EHD), dispensing, spraying, chemical vapor deposition (CVD), physical vapor deposition (PVD), magnetron sputtering, molecular beam epitaxy, electrochemical deposition, evaporation and the like.

[0125] According to an embodiment of the present invention, the second sensing layer 122 is formed on the second working electrode layer of the second working electrode by processes including but not limited to adsorption, printing, inkjet printing, electrohydrodynamic printing (EHD), dispensing, spraying, chemical vapor deposition (CVD), physical vapor deposition (PVD), magnetron sputtering, molecular beam epitaxy, electrochemical deposition, and evaporation.

[0126] According to an embodiment of the present invention, the thickness of the first sensing layer 115 and the thickness of the second sensing layer 122 are the same or different.

[0127] According to an embodiment of the present invention, the thickness of the first sensing layer 115 is 1 μm-20 μm, preferably 1 μm-10 μm, for example, 2 μm, 3 μm, 4 μm, 5 μm, 6 μm, 7 μm, 8 μm, 9 μm, 10 μm, 11 μm, 12 μm, 15 μm or 18 μm.

[0128] According to an embodiment of the present invention, the thickness of the second sensing layer 122 is 1 μm-20 μm, preferably 1 μm-10 μm, for example, 2 μm, 3 μm, 4 μm, 5 μm, 6 μm, 7 μm, 8 μm, 9 μm, 10 μm, 11 μm, 12 μm, 15 μm or 18 μm.

[0129] According to an embodiment of the present invention, the first sensing layer and the second sensing layer play a function of continuously monitoring multiple analytes.

[0130] According to an embodiment of the present invention, the analytes / physiological indicators that can be monitored by the first sensing layer and the second sensing layer include blood sugar, uric acid, lactic acid, blood ketones, cholesterol, triglycerides, heart rate, blood pressure, Na + ,Ka + , Ga 2+ , Fe 2+ and Mg 2+ One or more of the above.

[0131] Exemplarily, the analyte / physiological index that the first sensing layer can monitor is blood glucose; the analyte / physiological index that the second sensing layer can monitor includes uric acid, lactic acid, blood ketones, cholesterol, triglycerides, heart rate, blood pressure, Na + ,Ka + , Ga 2+ , Fe 2+ and Mg 2+ One of the above.

[0132] <Electrode Setup>

[0133] In the present invention, two electrodes that are spatially separated by a channel means that an electrode layer of one electrode and an electrode wire of the other electrode are spatially separated by a channel.

[0134] According to an embodiment of the present invention, the two electrodes separated in space by a channel are, for example, a first working electrode and a reference electrode, the first working electrode layer 107 of the first working electrode is located at the front end 101 of the substrate, the reference electrode layer 113 of the reference electrode is located at the middle end 102 of the substrate, and the reference electrode and the first working electrode are separated in space by a channel; or the first working electrode layer 107 of the first working electrode is located at the middle end 102 of the substrate, the reference electrode layer 113 of the reference electrode is located at the front end 101 of the substrate, and the reference electrode and the first working electrode are separated in space by a channel.

[0135] According to an embodiment of the present invention, the two electrodes separated in space by a channel are, for example, a second working electrode and a reference electrode, the second working electrode layer 119 of the second working electrode is located at the front end 101 of the substrate, the reference electrode layer 113 of the reference electrode is located at the middle end 102 of the substrate, and the reference electrode and the second working electrode are separated in space by a channel; or the second working electrode layer 119 of the second working electrode is located at the middle end 102 of the substrate, the reference electrode layer 113 of the reference electrode is located at the front end 101 of the substrate, and the reference electrode and the second working electrode are separated in space by a channel.

[0136] According to an embodiment of the present invention, the two electrodes separated in space by a channel are, for example, a first working electrode and a counter electrode, the first working electrode layer 107 of the first working electrode is located at the front end 101 of the substrate, the counter electrode layer 104 of the counter electrode is located at the middle end 102 of the substrate, and the counter electrode and the first working electrode are separated in space by a channel; or the first working electrode layer 107 of the first working electrode is located at the middle end 102 of the substrate, the counter electrode layer 104 of the counter electrode is located at the front end 101 of the substrate, and the counter electrode and the first working electrode are separated in space by a channel.

[0137] According to an embodiment of the present invention, the two electrodes separated in space by a channel are, for example, a second working electrode and a counter electrode, the second working electrode layer 119 of the second working electrode is located at the front end 101 of the substrate, the counter electrode layer 104 of the counter electrode is located at the middle end 102 of the substrate, and the counter electrode and the second working electrode are separated in space by a channel; or the second working electrode layer 119 of the second working electrode is located at the middle end 102 of the substrate, the counter electrode layer 104 of the counter electrode is located at the front end 101 of the substrate, and the counter electrode and the second working electrode are separated in space by a channel.

[0138] According to an embodiment of the present invention, the two electrodes separated in space by a channel are, for example, a counter electrode and a reference electrode, the reference electrode layer 113 of the reference electrode is located at the front end 101 of the substrate, the counter electrode layer 104 of the counter electrode is located at the middle end 102 of the substrate, and the reference electrode and the counter electrode are separated in space by a channel; or the reference electrode layer 113 of the reference electrode is located at the middle end 102 of the substrate, the counter electrode layer 104 of the counter electrode is located at the front end 101 of the substrate, and the reference electrode and the counter electrode are separated in space by a channel.

[0139] According to an embodiment of the present invention, the two electrodes separated in space by a channel are, for example, a first working electrode and a second working electrode, the first working electrode layer 107 of the first working electrode is located at the front end 101 of the substrate, the second working electrode layer 120 of the second working electrode is located at the middle end 102 of the substrate, and the first working electrode and the second working electrode are separated in space by a channel; or the first working electrode layer 107 of the first working electrode is located at the middle end 102 of the substrate, the second working electrode layer 120 of the second working electrode is located at the front end 101 of the substrate, and the first working electrode and the second working electrode are separated in space by a channel.

[0140] According to an embodiment of the present invention, when the first working electrode layer 107 of the first working electrode is located at the front end 101 of the substrate and the reference electrode layer 113 of the reference electrode is located at the middle end 102 of the substrate, the reference electrode layer 113 of the reference electrode and the first working electrode wire 108 of the first working electrode are spatially separated by a channel.

[0141] According to an embodiment of the present invention, when the first working electrode layer 107 of the first working electrode is located at the middle end 102 of the substrate and the reference electrode layer 113 of the reference electrode is located at the front end 101 of the substrate, the reference electrode wire 110 of the reference electrode and the first working electrode layer 107 of the first working electrode are spatially separated by a channel.

[0142] According to an embodiment of the present invention, when the first working electrode layer 107 of the first working electrode is located at the front end 101 of the substrate and the counter electrode layer 104 of the counter electrode is located at the middle end 102 of the substrate, the counter electrode layer 104 of the counter electrode and the first working electrode wire 108 of the first working electrode are spatially separated by a channel.

[0143] According to an embodiment of the present invention, when the first working electrode layer 107 of the first working electrode is located at the middle end 102 of the substrate and the counter electrode layer 104 of the counter electrode is located at the front end 101 of the substrate, the counter electrode wire 105 of the counter electrode and the first working electrode layer 107 of the first working electrode are spatially separated by a channel.

[0144] According to an embodiment of the present invention, when the second working electrode layer 119 of the second working electrode is located at the front end 101 of the substrate and the reference electrode layer 113 of the reference electrode is located at the middle end 102 of the substrate, the reference electrode layer 113 of the reference electrode and the second working electrode wire 120 of the second working electrode are spatially separated by a channel.

[0145] According to an embodiment of the present invention, when the second working electrode layer 119 of the second working electrode is located at the middle end 102 of the substrate and the reference electrode layer 113 of the reference electrode is located at the front end 101 of the substrate, the reference electrode wire 110 of the reference electrode and the second working electrode layer 119 of the second working electrode are spatially separated by a channel.

[0146] According to an embodiment of the present invention, when the second working electrode layer 119 of the second working electrode is located at the front end 101 of the substrate and the counter electrode layer 104 of the counter electrode is located at the middle end 102 of the substrate, the counter electrode layer 104 of the counter electrode and the second working electrode wire 120 of the second working electrode are spatially separated by a channel.

[0147] According to an embodiment of the present invention, when the second working electrode layer 119 of the second working electrode is located at the middle end 102 of the substrate and the counter electrode layer 104 of the counter electrode is located at the front end 101 of the substrate, the counter electrode wire 105 of the counter electrode and the second working electrode layer 119 of the second working electrode are spatially separated by a channel.

[0148] According to an embodiment of the present invention, when the reference electrode layer 113 of the reference electrode is located at the front end 101 of the substrate and the counter electrode layer 104 of the counter electrode is located at the middle end 102 of the substrate, the counter electrode layer 104 of the counter electrode and the reference electrode wire 110 of the reference electrode are spatially separated by a channel.

[0149] According to an embodiment of the present invention, when the reference electrode layer 113 of the reference electrode is located at the middle end 102 of the substrate and the counter electrode layer 104 of the counter electrode is located at the front end 101 of the substrate, the counter electrode wire 105 of the counter electrode and the reference electrode layer 113 of the reference electrode are spatially separated by a channel.

[0150] According to an embodiment of the present invention, when the first working electrode layer 107 of the first working electrode is located at the front end 101 of the substrate and the second working electrode layer 119 of the second working electrode is located at the middle end 102 of the substrate, the second working electrode layer 119 of the second working electrode and the first working electrode wire 108 of the first working electrode are spatially separated by a channel.

[0151] According to an embodiment of the present invention, when the first working electrode layer 107 of the first working electrode is located at the middle end 102 of the substrate and the second working electrode layer 119 of the second working electrode is located at the front end 101 of the substrate, the second working electrode wire 120 of the second working electrode and the first working electrode layer 107 of the first working electrode are spatially separated by a channel.

[0152] According to an embodiment of the present invention, when the two electrodes separated in space by a channel are the first working electrode and the reference electrode, the first working electrode and the reference electrode are located on the same plane, specifically, the first working electrode layer 107 of the first working electrode, the first working electrode wire 108 of the first working electrode, the first working electrode contact 109 of the first working electrode, the reference electrode layer 113 of the reference electrode, the reference electrode wire 110 of the reference electrode and the reference electrode contact 112 of the reference electrode are all located on the same plane; or, when the two electrodes separated in space by a channel are the first working electrode and the reference electrode, the first working electrode and the reference electrode are partially located on the same plane, specifically, at least one component of the electrode layers of the first working electrode and the reference electrode, the electrode wires of the first working electrode and the reference electrode, and the electrode contacts of the first working electrode and the reference electrode are located on the same plane, and at least one component of the electrode layers of the first working electrode and the reference electrode, the electrode wires of the first working electrode and the reference electrode, and the electrode contacts of the first working electrode and the reference electrode are not located on the same plane.

[0153] According to an embodiment of the present invention, when the two electrodes spatially separated by a channel are the second working electrode and the reference electrode, the second working electrode and the reference electrode are located on the same plane, specifically, the second working electrode layer 119 of the second working electrode, the second working electrode wire 120 of the second working electrode, the second working electrode contact 121 of the second working electrode, the reference electrode layer 113 of the reference electrode, the reference electrode wire 110 of the reference electrode and the reference electrode contact 112 of the reference electrode are all located on the same plane; or, when the two electrodes spatially separated by a channel are the second working electrode and the reference electrode, the second working electrode and the reference electrode are partially located on the same plane, specifically, at least one component of the electrode layers of the second working electrode and the reference electrode, the electrode wires of the second working electrode and the reference electrode, and the electrode contacts of the second working electrode and the reference electrode are located on the same plane, and at least one component of the electrode layers of the second working electrode and the reference electrode, the electrode wires of the second working electrode and the reference electrode, and the electrode contacts of the second working electrode and the reference electrode are not located on the same plane.

[0154] According to an embodiment of the present invention, when the two electrodes separated in space by a channel are the first working electrode and the counter electrode, the first working electrode and the counter electrode are located on the same plane, specifically, the first working electrode layer 107 of the first working electrode, the first working electrode wire 108 of the first working electrode, the first working electrode contact 109 of the first working electrode, the counter electrode layer 104 of the counter electrode, the counter electrode wire 105 of the counter electrode and the counter electrode contact 106 of the counter electrode are all located on the same plane; or, when the two electrodes separated in space by a channel are the first working electrode and the counter electrode, the first working electrode and the counter electrode are partially located on the same plane, specifically, at least one component of the electrode layers of the first working electrode and the counter electrode, the electrode wires of the first working electrode and the counter electrode, and the electrode contacts of the first working electrode and the counter electrode are located on the same plane, and at least one component of the electrode layers of the first working electrode and the counter electrode, the electrode wires of the first working electrode and the counter electrode, and the electrode contacts of the first working electrode and the counter electrode are not located on the same plane.

[0155] According to an embodiment of the present invention, when the two electrodes separated in space by a channel are the second working electrode and the counter electrode, the second working electrode and the counter electrode are located on the same plane, specifically, the second working electrode layer 119 of the second working electrode, the second working electrode wire 120 of the second working electrode, the second working electrode contact 121 of the second working electrode, the counter electrode layer 104 of the counter electrode, the counter electrode wire 105 of the counter electrode and the counter electrode contact 106 of the counter electrode are all located on the same plane; or, when the two electrodes separated in space by a channel are the second working electrode and the counter electrode, the second working electrode and the counter electrode are partially located on the same plane, specifically, at least one component of the electrode layers of the second working electrode and the counter electrode, the electrode wires of the second working electrode and the counter electrode, and the electrode contacts of the second working electrode and the counter electrode are located on the same plane, and at least one component of the electrode layers of the second working electrode and the counter electrode, the electrode wires of the second working electrode and the counter electrode, and the electrode contacts of the second working electrode and the counter electrode are not located on the same plane.

[0156] According to an embodiment of the present invention, when the two electrodes separated in space by a channel are the counter electrode and the reference electrode, the counter electrode and the reference electrode are located on the same plane, specifically, the counter electrode layer 104 of the counter electrode, the counter electrode wire 105 of the counter electrode, the counter electrode contact 106 of the counter electrode, the reference electrode layer 113 of the reference electrode, the reference electrode wire 110 of the reference electrode and the reference electrode contact 112 of the reference electrode are all located on the same plane; or, when the two electrodes separated in space by a channel are the counter electrode and the reference electrode, the counter electrode and the reference electrode are partially located on the same plane, specifically, at least one component of the electrode layers of the counter electrode and the reference electrode, the electrode wires of the counter electrode and the reference electrode, and the electrode contacts of the counter electrode and the reference electrode are located on the same plane, and at least one component of the electrode layers of the counter electrode and the reference electrode, the electrode wires of the counter electrode and the reference electrode, and the electrode contacts of the counter electrode and the reference electrode are not located on the same plane.

[0157] According to an embodiment of the present invention, when the two electrodes separated in space by a channel are the first working electrode and the second working electrode, the first working electrode and the second working electrode are located on the same plane, specifically, the first working electrode layer 107 of the first working electrode, the first working electrode wire 108 of the first working electrode, the first working electrode contact 109 of the first working electrode, the second working electrode layer 119 of the second working electrode, the second working electrode wire 120 of the second working electrode, and the second working electrode contact 121 of the second working electrode are all located on the same plane; or, when the two electrodes separated in space by a channel are the first working electrode and the second working electrode, the first working electrode and the second working electrode are partially located on the same plane, specifically, at least one component of the electrode layers of the first working electrode and the second working electrode, the electrode wires of the first working electrode and the second working electrode, and the electrode contacts of the first working electrode and the second working electrode are located on the same plane, and at least one component of the electrode layers of the first working electrode and the second working electrode, the electrode wires of the first working electrode and the second working electrode, and the electrode contacts of the first working electrode and the second working electrode are not located on the same plane.

[0158] <Channel Structure>

[0159] According to an embodiment of the present invention, Fig.41 As shown, the width of the channel 114 refers to the distance between the electrode layer of one electrode and the electrode wire of the other electrode in the two electrodes separated by the channel in space, as shown in FIG. Fig.41The middle line segment "W" represents the width of the channel 114; the specific electrode layers and electrode wires need to be determined according to the different arrangements of the first working electrode, the second working electrode, the reference electrode and the counter electrode inside the sensor; illustratively, the width of the channel refers to the distance between the counter electrode wire 105 of the counter electrode and the reference electrode layer 113 of the reference electrode; or refers to the distance between the counter electrode wire 105 of the counter electrode and the first working electrode layer 107 of the first working electrode; or refers to the distance between the counter electrode wire 105 of the counter electrode and the second working electrode layer 119 of the second working electrode; or refers to the distance between the reference electrode wire 110 of the reference electrode and the first working electrode layer 107 of the first working electrode; or refers to the distance between the reference electrode wire 110 of the reference electrode and the counter electrode layer 104 of the counter electrode; or refers to the distance between the reference electrode The distance between the reference electrode wire 110 and the second working electrode layer 119 of the second working electrode; or the distance between the first working electrode wire 108 of the first working electrode and the counter electrode layer 104 of the counter electrode; or the distance between the first working electrode wire 108 of the first working electrode and the reference electrode layer 113 of the reference electrode; or the distance between the first working electrode wire 108 of the first working electrode and the second working electrode layer 119 of the second working electrode; or the distance between the second working electrode wire 120 of the second working electrode and the counter electrode layer 104 of the counter electrode; or the distance between the second working electrode wire 120 of the second working electrode and the reference electrode layer 113 of the reference electrode; or the distance between the second working electrode wire 120 of the second working electrode and the first working electrode layer 107 of the first working electrode.

[0160] According to an embodiment of the present invention, the width of the channel can be fixed or gradual; if fixed, the width of the channel is a fixed value in the range of 1μm-280μm; if gradual, the width of the channel gradually increases or decreases along the direction from the front end 101 of the substrate to the middle end 102 of the substrate, and the width of the channel varies within a width variation range within the range of 1μm-280μm, for example, varies within a width range of 50μm-150μm or varies within a width range of 80μm-200μm.

[0161] According to an embodiment of the present invention, the width of the channel is 1μm-280μm, preferably 50μm-170μm, for example, 20μm, 30μm, 40μm, 50μm, 60μm, 70μm, 80μm, 90μm, 100μm, 110μm, 120μm, 130μm, 140μm, 150μm, 160μm, 170μm, 180μm, 190μm, 200μm, 210μm, 220μm, 230μm, 240μm, 250μm, 260μm, 270μm, 280μm or a range consisting of the above two endpoints. The study found that when the width of the channel is 1μm-280μm, it can effectively separate the electrodes located on the same side surface of the sensor, so that the functions of multiple functional areas / electrode areas can be realized on the same side surface of the sensor, which is beneficial to improving the stability of the sensor; when the width of the channel is less than 1μm, due to the narrowness of the channel width, there is a risk of contact between the two electrodes, resulting in a short circuit between the electrodes and thus causing the test data to be too high or too low, causing the sensor to fail; when the width of the channel is greater than 280μm, due to the wideness of the channel width, the electrode / electrode wire will be too narrow, which may lead to insufficient area of ​​the functional area / electrode area, or the electrode / electrode wire will be too narrow, resulting in an electrode break, resulting in data "jumps" or "jitters" during the sensor test, affecting the stability of the test data and causing the sensor to fail.

[0162] According to an embodiment of the present invention, Fig.41 As shown, the length of the channel 114 refers to the distance from the front end of the electrode layer located at the middle end of the substrate to the connection between the first side and the second side of the substrate, that is, Fig.41 The middle line segment "D" represents the length of the channel 114; the specific electrode layer needs to be determined according to the different arrangements of the first working electrode, the second working electrode, the reference electrode and the counter electrode in the sensor; illustratively, the length of the channel is the distance from the front end of the first working electrode layer of the first working electrode located at the middle end of the substrate to the connection between the first and second sides of the substrate; or the length of the channel is the distance from the front end of the second working electrode layer of the second working electrode located at the middle end of the substrate to the connection between the first and second sides of the substrate; or the distance from the front end of the reference electrode layer of the reference electrode located at the middle end of the substrate to the connection between the first and second sides of the substrate; or the distance from the front end of the counter electrode layer of the counter electrode located at the middle end of the substrate to the connection between the first and second sides of the substrate. The front end of the electrode layer refers to the end close to the front end of the substrate.

[0163] According to an embodiment of the present invention, the length of the channel is 30 μm-10000 μm, for example, 30 μm, 40 μm, 50 μm, 60 μm, 70 μm, 80 μm, 90 μm, 100 μm, 110 μm, 120 μm, 130 μm, 140 μm, 150 μm, 160 μm, 170 μm, 180 μm, 190 μm, 200 μm, 210 μm, 220 μm, 230 μm, 240 μm, 250 μm, 260 μm, 270 μm, 280 μm, 300 μm, 320 μm, 350 μm, 380 μm, 400 μm, 410 μm, 420 μm, 430 μm, 440 μm, 450 μm, 460 μm, 470 μm, 480 μm, 490 μm, 500 μm, 510 μm, 520 μm, 530 μm, 540 μm, 550 μm, 560 μm, 570 μm, 580 μm, 590 μm, 600 μm, 610 μm, 620 μm, 630 μm, 640 μm, 650 μm, 660 μm, 670 μm, 680 μm, 690 μm, 700 μm, 710 μm, 720 μm, 730 μm, 740 μm, 750 μm, 760 μm, 770 μm, 780 μm, 79 00μm,450μm,500μm,550μm,600μm,700μm,800μm,900μm,1000μm,1100μm,1200μm,1300μm,1400μm,1500μm,2000μm,2500μm,3 000μm, 3500μm, 4000μm, 4500μm, 5000μm, 5500μm, 6000μm, 6500μm, 7000μm, 7500μm, 8000μm, 8500μm, 9000μm, 9500μm or 10000μm. The study found that when the length of the channel is 30μm-10000μm, it can effectively monitor the monitored object and provide better wearing comfort; when the length of the channel is less than 30μm, the analyte sensor may not be able to effectively contact body fluids, and thus there is a risk of being unable to monitor; when the length of the channel is greater than 10000μm, due to excessive implantation, the wearer is prone to bleeding and pain, affecting the wearing experience.

[0164] According to an embodiment of the present invention, the channel can be obtained by printing, engraving, etching, inkjet printing, electrohydrodynamic printing (EHD), dispensing, spraying, chemical vapor deposition (CVD), physical vapor deposition (PVD), magnetron sputtering, molecular beam epitaxy, electrochemical deposition, evaporation and the like.

[0165] <Sensor Structure>

[0166] According to an embodiment of the present invention, the analyte sensor is a four-electrode system, and the combined use of the four electrodes can play a role in stabilizing the potential.

[0167] According to an embodiment of the present invention, the analyte sensor can continuously monitor for 7-360 days. The analyte sensor can continuously monitor two analytes / physiological indicators, for example, more than once a day, such as 1-10 times; or more than once an hour, such as 1-10 times; or more than once a minute, such as 1-30 times; or more than once a second, such as 1-10 times.

[0168] According to an embodiment of the present invention, the analyte sensor has an L shape. The L-shaped sensor can be adapted to the auxiliary device to better complete the analysis work; on the other hand, the L shape can effectively prevent the sensor from being damaged during implantation, increasing the probability of successful sensor implantation.

[0169] According to an embodiment of the present invention, the analyte sensor has an L shape, wherein the L shape includes a first side and a second side, and a connection between the first side and the second side forms an angle of 45°-135°, preferably 88°-98°.

[0170] According to an embodiment of the present invention, the first surface of the analyte sensor has two contact areas and two electrode areas, and the second surface of the analyte sensor opposite to the first surface has one contact area and one electrode area. Further, the electrode area is arranged on a first side of the L-shaped sensor, and the contact area is arranged on a second side of the sensor.

[0171] According to an embodiment of the present invention, the first surface of the analyte sensor has two contact areas and two electrode areas, and the second surface of the analyte sensor opposite to the first surface has two contact areas and two electrode areas.

[0172] According to an embodiment of the present invention, the first surface of the analyte sensor has three contact areas and three electrode areas, and the second surface of the analyte sensor opposite to the first surface has one contact area and one electrode area. Further, the electrode area is arranged on a first side of the L-shaped sensor, and the contact area is arranged on a second side of the sensor.

[0173] <Protrusion structure>

[0174] According to an embodiment of the present invention, the connection between the first side and the second side forms a protrusion structure 118. Preferably, the outer edge of the connection between the first side and the second side forms a protrusion structure, and the setting of the protrusion structure can make the sensor adapt to the auxiliary device during implantation, and can make the sensor implantation smoother.

[0175] According to an embodiment of the present invention, the shape of the protrusion structure can be semicircular, triangular, square or polygonal, such as Fig.34 shown.

[0176] According to an embodiment of the present invention, the number of the protrusion structure may be one or more. Fig.34 shown.

[0177] <Dielectric layer>

[0178] According to an embodiment of the present invention, the dielectric layer is arranged on the surface of the first working electrode wire of the first working electrode, and is used to protect the working electrode from being damaged; the dielectric layer is arranged on the surface of the second working electrode wire of the second working electrode, and is used to protect the working electrode from being damaged; the dielectric layer is arranged on the surface of the reference electrode, and is used to protect the reference electrode from being damaged; the dielectric layer is arranged on the surface of the counter electrode wire of the counter electrode, and is used to protect the counter electrode from being damaged.

[0179] According to an embodiment of the present invention, the material forming the dielectric layer includes at least one of plastic (such as polyethylene terephthalate PET, polyimide PI, polyvinyl chloride PVC or polyethylene PE), polydimethylsiloxane PDMS, ceramics, glass, paper and textiles.

[0180] According to an embodiment of the present invention, the dielectric layer is formed on the reference electrode, the working electrode wire or the counter electrode wire by processes including but not limited to adsorption, printing, inkjet printing, electrohydrogen jet printing (EHD), dispensing, spraying, chemical vapor deposition (CVD), physical vapor deposition (PVD), magnetron sputtering, molecular beam epitaxy, electrochemical deposition, evaporation and the like.

[0181] According to an embodiment of the present invention, the thickness of the dielectric layer is 1μm-1000μm, preferably 10μm-500μm, for example, 10μm, 20μm, 50μm, 80μm, 100μm, 120μm, 150μm, 180μm, 200μm, 220μm, 250μm, 260μm, 280μm, 300μm, 320μm, 350μm, 380μm, 400μm, 420μm, 450μm, 480μm, 500μm, 600μm, 700μm, 800μm, 900μm or 1000μm.

[0182] In all sensor configurations disclosed herein, the various electrodes may be isolated from each other by channels.

[0183] <Protective layer>

[0184] According to an embodiment of the present invention, the analyte sensor further includes a protective layer 116 , which is disposed at the outermost layer of the sensor.

[0185] According to an embodiment of the present invention, the protective layer may be a single-layer structure or a multi-layer structure.

[0186] According to an embodiment of the present invention, the protective layer may have the function of limiting flux. The protective layer may have the function of preventing biofouling. The protective layer may have the function of shielding environmental noise. The protective layer may have the function of protecting internal components / elements from corrosion and damage.

[0187] According to an embodiment of the present invention, the protective layer may be in a gel state or a solid state.

[0188] According to an embodiment of the present invention, the protective layer may be some component, such as a filter.

[0189] According to an embodiment of the present invention, the material forming the protective layer may be an ethylene homopolymer or an ethylene copolymer.

[0190] According to an embodiment of the present invention, the thickness of the protective layer is 0.5μm-2000μm. Preferably, the thickness of the protective layer is 2μm-1000μm, for example, 5μm, 10μm, 50μm, 80μm, 100μm, 150μm, 200μm, 250μm, 300μm, 350μm, 400μm, 450μm, 500μm, 600μm, 700μm, 800μm, 900μm or 1000μm.

[0191] According to an embodiment of the present invention, the protective layer is modified onto the sensor by processes including but not limited to dispensing, spin coating, spraying, dipping, scraping, nesting, wrapping, printing, inkjet printing, electrohydrodynamic printing (EHD), electrospinning, chemical vapor deposition (CVD), physical vapor deposition (PVD), magnetron sputtering, molecular beam epitaxy, electrochemical deposition, evaporation and the like.

[0192] <Analyte Sensor Related Description>

[0193] According to an embodiment of the present invention, the analyte sensor may use any one of the first, second, third or fourth generation technologies for monitoring blood glucose. Specifically, different detection technologies may be used to monitor blood glucose depending on the working electrode material and the sensing layer material.

[0194] According to an embodiment of the present invention, the analyte sensor includes a first working electrode, a second working electrode, a reference electrode and a counter electrode. The analyte sensor is implanted into the body in a minimally invasive manner using an auxiliary device. Specifically, the front end and part of the middle end (that is, the position below the protrusion structure, one side of the L shape) of the analyte sensor are implanted into the body. The first working electrode and the counter electrode form a current loop, the first working electrode and the reference electrode form a voltage loop, the second working electrode and the counter electrode form a current loop, and the second working electrode and the reference electrode form a voltage loop, so that the first sensing layer located on the first working electrode generates an electrochemical signal after reacting with the first analyte, thereby achieving the purpose of monitoring the first analyte, and the second sensing layer located on the second working electrode generates an electrochemical signal after reacting with the second analyte, thereby achieving the purpose of monitoring the second analyte; further, there is a corresponding relationship between the strength of the generated electrochemical signal and the analyte concentration, that is, the higher the analyte concentration, the stronger the generated electrochemical property.

[0195] According to an embodiment of the present invention, the analyte sensor can detect the first analyte and the second analyte by one analytical method, or can detect the first analyte and the second analyte respectively by two analytical methods. Exemplarily, the analytical method is electrochemistry + electrochemistry, electrochemistry + mechanics, electrochemistry + mechanics, electrochemistry + electricity, electrochemistry + thermal, electrochemistry + optics, electrochemistry + acoustics, electrochemistry + electromagnetics, and the like.

[0196] According to an embodiment of the present invention, the analyte sensor may contain an enzyme or not contain an enzyme, or a combination of enzymes and no enzymes. For example, the analyte sensor may detect / monitor blood glucose + uric acid, lactic acid, blood ketones, cholesterol, triglycerides, heart rate, blood pressure, Na+, etc., by using enzyme or no enzyme sensor technology. + ,Ka + , Ga 2+ , Fe 2+ Mg 2+ wait.

[0197] According to an embodiment of the present invention, the analyte sensor includes a first working electrode, a second working electrode, a reference electrode and a counter electrode. The analyte sensor is implanted into the body in a minimally invasive manner using an auxiliary device. Specifically, the front end and part of the middle end (i.e., the position below the protrusion structure, one side of the L shape) of the analyte sensor are implanted into the body. The first working electrode, the second working electrode and the counter electrode are used to form a current loop, and the first working electrode, the second working electrode and the reference electrode are used to form a voltage loop, so that the first sensing layer located on the first working electrode generates an electrochemical signal after reacting with the first analyte, thereby achieving the purpose of monitoring the first analyte. At the same time, the second sensing layer located on the second working electrode generates an electrochemical signal after reacting with the second analyte, thereby achieving the purpose of monitoring the second analyte. Furthermore, there is a corresponding relationship between the strength of the generated electrochemical signal and the analyte concentration, that is, the higher the analyte concentration, the stronger the generated electrochemical property.

[0198] <Detection Method for Determining Analyte>

[0199] A detection method for determining an analyte, the detection method comprising:

[0200] 1) exposing the analyte sensor to a fluid including a first analyte and a second analyte of different concentrations, applying a voltage to a first working electrode in the sensor to obtain a first electrochemical signal of different signal strengths, wherein the signal strength of the first electrochemical signal is proportional to the concentration of the first analyte in the fluid; applying a voltage to a second working electrode in the sensor to obtain a second electrochemical signal of different signal strengths, wherein the signal strength of the second electrochemical signal is proportional to the concentration of the second analyte in the fluid;

[0201] 2) correlating the signal intensity of the first electrochemical signal with the concentration of the first analyte in the fluid, and plotting a standard curve of the signal intensity of the first electrochemical signal and the concentration of the first analyte; correlating the signal intensity of the second electrochemical signal with the concentration of the second analyte in the fluid, and plotting a standard curve of the signal intensity of the second electrochemical signal and the concentration of the second analyte;

[0202] 3) exposing the analyte sensor to a fluid including a first analyte to be monitored and a second analyte, applying a voltage to a first working electrode in the sensor to obtain a first electrochemical signal, and obtaining the concentration of the first analyte to be monitored in the fluid based on the signal strength of the first electrochemical signal; applying a voltage to a second working electrode in the sensor to obtain a second electrochemical signal, and obtaining the concentration of the second analyte to be monitored in the fluid based on the signal strength of the second electrochemical signal.

[0203] The present invention will be described in further detail below in conjunction with specific embodiments. It should be understood that the following embodiments are only exemplary descriptions and explanations of the present invention and should not be construed as limiting the scope of protection of the present invention. All technologies implemented based on the above content of the present invention are included in the scope that the present invention is intended to protect.

[0204] Unless otherwise specified, the experimental methods used in the following examples are all conventional methods; the reagents, materials, etc. used in the following examples, unless otherwise specified, can be obtained from commercial channels.

[0205] Example 1

[0206] The structure of the sensor electrode structure A of Example 1 is as follows Figure 1-Figure 4 shown. Figure 1 1 is a view of the sensor electrode structure A of Example 1, wherein the left image is a back view of the sensor electrode structure A, the middle image is a front second layer view of the sensor electrode structure A, and the right image is a front first layer view of the sensor electrode structure A. Figure 1 It can be seen that the sensor electrode structure A includes a substrate 100, a reference electrode, a counter electrode, a first working electrode and a second working electrode: the substrate 100 has an L-shaped structure, and the substrate 100 includes a front end 101, a middle end 102 and a terminal end 103; wherein, the reference electrode, the first working electrode and the second working electrode are located on the first surface of the substrate 100 (i.e., the front side of the sensor electrode structure A), and the counter electrode is located on the second surface of the substrate 100 opposite to the first surface (i.e., the back side of the sensor electrode structure A); specifically, the first working electrode is arranged on the surface of the substrate 100, the reference electrode stack is arranged on the surface of the first working electrode and is separated by a dielectric layer 117, the second working electrode stack is arranged on the surface of the first working electrode and is separated by a dielectric layer 117, the second working electrode and the reference electrode are spatially separated by a channel, and all components of the second working electrode and the reference electrode are located on the same plane.

[0207] The first working electrode comprises a first working electrode layer 107 located at the front end 101 of the substrate, a first working electrode wire 108 located at the middle end 102 of the substrate, and a first working electrode contact 109 located at the end 103 of the substrate; the first working electrode comprises a first sensing layer 115, and the first sensing layer 115 is located on the first working electrode layer 107; the second working electrode comprises a second working electrode layer 119 located at the front end 101 of the substrate, a second working electrode wire 120 located at the middle end 102 of the substrate, and a second working electrode contact 109 located at the end 103 of the substrate. 121; the second working electrode includes a second sensing layer 122, and the second sensing layer 122 is located on the second working electrode layer 119; the reference electrode includes a reference electrode layer 113 and a reference electrode wire 110 located at the middle end 102 of the substrate, and a reference electrode contact 112 located at the end 103 of the substrate, and the reference electrode layer 113 is arranged on the reference electrode wire 110; the counter electrode includes a counter electrode layer 104 located at the front end 101 of the substrate, a counter electrode wire 105 located at the middle end 102 of the substrate, and a counter electrode contact 106 located at the end 103 of the substrate.

[0208] The sensor electrode structure A includes a channel 114 located between the second working electrode wire 120 of the second working electrode and the reference electrode layer 113, and the second working electrode and the reference electrode are separated by the channel 114, the width of the channel 114 is adjustable within the range of 1μm-280μm, and the length of the channel is adjustable within the range of 30μm-10000μm. The sensor electrode structure A has an L shape, including a first side and a second side, and the connection between the first side and the second side forms an angle, and the angle is 85°-95°. A protrusion structure 118 is formed at the outer edge of the connection between the first side and the second side. The sensor electrode structure A includes a protective layer 116, and the protective layer 116 is arranged on the outside of the sensor.

[0209] Figure 2 Schematic diagram of the structure of the AA' section of the sensor electrode structure A of Example 1. Figure 3 Schematic diagram of the structure of the BB' section of the sensor electrode structure A of Example 1. Figure 4 FIG. 1 is a schematic structural diagram of the CC' section of the sensor electrode structure A of Example 1. Figure 2-Figure 4 It can be seen that the first working electrode is arranged on the surface of the substrate 100, the reference electrode stack is arranged on the surface of the first working electrode and separated by the dielectric layer 117, the second working electrode stack is arranged on the surface of the first working electrode and separated by the dielectric layer 117, the second working electrode and the reference electrode are spatially separated by a channel, and all components of the second working electrode and the reference electrode are located on the same plane; the first working electrode is closer to the front end 101 of the substrate than the reference electrode and the second working electrode.

[0210] Example 2

[0211] The structure of the sensor electrode structure B of Example 2 is as follows Figure 5-Figure 8 shown. Figure 5 1 is a view of the sensor electrode structure B of Example 2, wherein the left image is a second layer view of the back side of the sensor electrode structure B, the middle image is a first layer view of the back side of the sensor electrode structure B, and the right image is a front view of the sensor electrode structure B. Figure 5 As can be seen in the figure, the sensor electrode structure B includes a substrate 100, a reference electrode, a counter electrode, a first working electrode and a second working electrode: the substrate 100 has an L-shaped structure, and the substrate 100 includes a front end 101, a middle end 102 and a terminal end 103; wherein, the reference electrode, the counter electrode and the second working electrode are located on the second surface of the substrate 100 opposite to the first surface (i.e., the back side of the sensor electrode structure B), and the first working electrode is located on the first surface of the substrate 100 (i.e., the front side of the sensor electrode structure B); specifically, the second working electrode is arranged on the surface of the substrate 100, the reference electrode stack is arranged on the surface of the second working electrode and is separated by a dielectric layer 117, the counter electrode stack is arranged on the surface of the second working electrode and is separated by a dielectric layer 117, the counter electrode and the reference electrode are spatially separated by a channel, and all components of the counter electrode and the reference electrode are located on the same plane.

[0212] The first working electrode comprises a first working electrode layer 107 located at the front end 101 of the substrate, a first working electrode wire 108 located at the middle end 102 of the substrate, and a first working electrode contact 109 located at the end 103 of the substrate; the first working electrode comprises a first sensing layer 115 located on the first working electrode layer 107; the second working electrode comprises a second working electrode layer 119 located at the front end 101 of the substrate, a second working electrode wire 120 located at the middle end 102 of the substrate, and a second working electrode contact 109 located at the end 103 of the substrate. 121; the second working electrode includes a second sensing layer 122 located on the second working electrode layer 119; the reference electrode includes a reference electrode layer 113 and a reference electrode wire 110 located at the middle end 102 of the substrate, and a reference electrode contact 112 located at the end 103 of the substrate, and the reference electrode layer 113 is arranged on the reference electrode wire 110; the counter electrode includes a counter electrode layer 104 located at the front end 101 of the substrate, a counter electrode wire 105 located at the middle end 102 of the substrate, and a counter electrode contact 106 located at the end 103 of the substrate.

[0213] The sensor electrode structure B includes a channel 114 located between the counter electrode wire 105 and the reference electrode layer 113, and the counter electrode and the reference electrode are separated by the channel 114. The width of the channel 114 is adjustable within the range of 1μm-280μm, and the length of the channel is adjustable within the range of 30μm-10000μm. The sensor electrode structure B has an L shape, including a first side and a second side, and the connection between the first side and the second side forms an angle, and the angle is 85°-95°. A protrusion structure 118 is formed at the outer edge of the connection between the first side and the second side. The sensor electrode structure B includes a protective layer 116, and the protective layer 116 is arranged on the outside of the sensor.

[0214] Figure 6 Schematic diagram of the structure of the AA' section of the sensor electrode structure B of Example 2. Figure 7 Schematic diagram of the structure of the BB' section of the sensor electrode structure B of Example 2. Figure 8 FIG. 1 is a schematic structural diagram of the CC' section of the sensor electrode structure B of Example 2. Figure 6-Figure 8 It can be seen that the second working electrode is arranged on the surface of the substrate 100, the reference electrode stack is arranged on the surface of the second working electrode and separated by the dielectric layer 117, the counter electrode stack is arranged on the surface of the second working electrode and separated by the dielectric layer 117, the counter electrode and the reference electrode are spatially separated by a channel, and all components of the counter electrode and the reference electrode are located on the same plane; the second working electrode is closer to the front end 101 of the substrate than the reference electrode and the counter electrode.

[0215] Example 3

[0216] The structure of the sensor electrode structure C of Example 3 is as follows Figure 9-12 shown. Fig. 9 3 are views of the sensor electrode structure C of Example 3, wherein the left image is a back view of the sensor electrode structure C, the middle image is a front second layer view of the sensor electrode structure C, and the right image is a front first layer view of the sensor electrode structure C. Fig. 9It can be seen that the sensor electrode structure C includes a substrate 100, a reference electrode, a counter electrode, a first working electrode and a second working electrode: the substrate 100 has an L-shaped structure, and the substrate 100 includes a front end 101, a middle end 102 and a terminal end 103; wherein, the reference electrode and the counter electrode are located on the second surface of the substrate 100 opposite to the first surface (i.e., the back side of the sensor electrode structure C), and the first working electrode and the second working electrode are located on the first surface of the substrate 100 (i.e., the front side of the sensor electrode structure C); specifically, the first working electrode is arranged on the first surface of the substrate 100, and the second working electrode stack is arranged on the surface of the first working electrode and is separated by a dielectric layer 117; the first working electrode is closer to the front end 101 of the substrate than the second working electrode; the counter electrode and the reference electrode are arranged on the second surface of the substrate 100 opposite to the first surface, the counter electrode and the reference electrode are spatially separated by a channel, and all components of the counter electrode and the reference electrode are located on the same plane.

[0217] The first working electrode comprises a first working electrode layer 107 located at the front end 101 of the substrate, a first working electrode wire 108 located at the middle end 102 of the substrate, and a first working electrode contact 109 located at the end 103 of the substrate; the first working electrode comprises a first sensing layer 115, and the first sensing layer 115 is located on the first working electrode layer 107; the second working electrode comprises a second working electrode layer 119 and a second working electrode wire 120 located at the middle end 102 of the substrate, and a second working electrode contact 121 located at the end 103 of the substrate; The second working electrode includes a second sensing layer 122, and the second sensing layer 122 is located on the second working electrode layer 119; the reference electrode includes a reference electrode layer 113 and a reference electrode wire 110 located at the middle end 102 of the substrate, and a reference electrode contact 112 located at the end 103 of the substrate, and the reference electrode layer 113 is arranged on the reference electrode wire 110; the counter electrode includes a counter electrode layer 104 located at the front end 101 of the substrate, a counter electrode wire 105 located at the middle end 102 of the substrate, and a counter electrode contact 106 located at the end 103 of the substrate.

[0218] The sensor electrode structure C includes a channel 114 located between the counter electrode wire 105 and the reference electrode layer 113, and the counter electrode and the reference electrode are separated by the channel 114. The width of the channel 114 is adjustable within the range of 1 μm-280 μm, and the length of the channel is adjustable within the range of 30 μm-10000 μm. The sensor electrode structure C has an L shape, including a first side and a second side, and the connection between the first side and the second side forms an angle, and the angle is 85°-95°. A protrusion structure 118 is formed at the outer edge of the connection between the first side and the second side. The sensor electrode structure C includes a protective layer 116, and the protective layer 116 is arranged on the outside of the sensor.

[0219] Fig.10Schematic diagram of the structure of the AA' section of the sensor electrode structure C of Example 3. Fig.11 Schematic diagram of the structure of the BB' section of the sensor electrode structure C of Example 3. Fig.12 FIG. 1 is a schematic structural diagram of the CC' section of the sensor electrode structure C of Example 3. Figure 10-12 It can be seen that the first working electrode is arranged on the first surface of the substrate 100, and the second working electrode stack is arranged on the surface of the first working electrode and separated by the dielectric layer 117; the first working electrode is closer to the front end 101 of the substrate than the second working electrode; the counter electrode and the reference electrode are arranged on the second surface of the substrate 100 opposite to the first surface, the counter electrode and the reference electrode are separated in space by a channel, and all components of the counter electrode and the reference electrode are located on the same plane.

[0220] Example 4

[0221] The structure of the sensor electrode structure D of Example 4 is as follows Figure 13-Figure 16 shown. Fig.13 4 are views of the sensor electrode structure D of Example 4, wherein the left image is a second-layer view of the back side of the sensor electrode structure D, the middle image is a first-layer view of the back side of the sensor electrode structure D, and the right image is a front view of the sensor electrode structure D. Fig.13 It can be seen that the sensor electrode structure D includes a substrate 100, a reference electrode, a counter electrode, a first working electrode and a second working electrode: the substrate 100 has an L-shaped structure, and the substrate 100 includes a front end 101, a middle end 102 and a terminal end 103; wherein, the reference electrode and the counter electrode are located on the second surface of the substrate 100 opposite to the first surface (i.e., the back side of the sensor electrode structure D), and the first working electrode and the second working electrode are located on the first surface of the substrate 100 (i.e., the front side of the sensor electrode structure D); specifically, the first working electrode and the second working electrode are arranged on the first surface of the substrate 100, and the first working electrode and the second working electrode are separated in space by a channel, and all components of the first working electrode and the second working electrode are located on the same plane; the counter electrode is arranged on the second surface of the substrate 100 opposite to the first surface, and the reference electrode stack is arranged on the surface of the counter electrode and separated by a dielectric layer 117; the counter electrode is closer to the front end 101 of the substrate than the reference electrode.

[0222] The first working electrode includes a first working electrode layer 107 located at the front end 101 of the substrate, a first working electrode wire 108 located at the middle end 102 of the substrate, and a first working electrode contact 109 located at the end 103 of the substrate; the first working electrode includes a first sensing layer 115 located on the first working electrode layer 107; the second working electrode includes a second working electrode layer 119 and a second working electrode wire 120 located at the middle end 102 of the substrate, and a second working electrode contact 121 located at the end 103 of the substrate; the second working electrode includes a second sensing layer 122 located on the second working electrode layer 119; the reference electrode includes a reference electrode layer 113 and a reference electrode wire 110 located at the middle end 102 of the substrate, and a reference electrode contact 112 located at the end 103 of the substrate, and the reference electrode layer 113 is arranged on the reference electrode wire 110; the counter electrode includes a counter electrode layer 104 located at the front end 101 of the substrate, a counter electrode wire 105 located at the middle end 102 of the substrate, and a counter electrode contact 106 located at the end 103 of the substrate.

[0223] The sensor electrode structure D includes a channel 114 located between the first working electrode wire 108 and the second working electrode layer 119, and the first working electrode and the second working electrode are separated by the channel 114. The width of the channel 114 is adjustable within the range of 1 μm-280 μm, and the length of the channel is adjustable within the range of 30 μm-10000 μm. The sensor electrode structure D has an L shape, including a first side and a second side, and the connection between the first side and the second side forms an angle, and the angle is 85°-95°. A protrusion structure 118 is formed at the outer edge of the connection between the first side and the second side. The sensor electrode structure D includes a protective layer 116, and the protective layer 116 is arranged on the outside of the sensor.

[0224] Fig.14 Schematic diagram of the structure of the AA' section of the sensor electrode structure D of Example 4. Fig.15 Schematic diagram of the structure of the BB' section of the sensor electrode structure D of Example 4. Fig.16 FIG. 4 is a schematic structural diagram of the CC' section of the sensor electrode structure D of Example 4. Figure 14-16 It can be seen that the first working electrode and the second working electrode are arranged on the first surface of the substrate 100, and the first working electrode and the second working electrode are separated in space by a channel, and all components of the first working electrode and the second working electrode are located on the same plane; the counter electrode is arranged on the second surface of the substrate 100 opposite to the first surface, and the reference electrode stack is arranged on the surface of the counter electrode and separated by a dielectric layer 117; the counter electrode is closer to the front end 101 of the substrate than the reference electrode.

[0225] Example 5

[0226] The structure of the sensor electrode structure E of Example 5 is as follows Figure 17-Figure 20 shown. Fig.17 1 is a view of the sensor electrode structure E of Example 5, wherein the left image is a second-layer view of the back side of the sensor electrode structure E, the second left image is a first-layer view of the back side of the sensor electrode structure E, the right image is a first-layer view of the front side of the sensor electrode structure E, and the second right image is a second-layer view of the front side of the sensor electrode structure E. Fig.17 It can be seen that the sensor electrode structure E includes a substrate 100, a reference electrode, a counter electrode, a first working electrode and a second working electrode: the substrate 100 has an L-shaped structure, and the substrate 100 includes a front end 101, a middle end 102 and a terminal end 103; wherein, the reference electrode and the counter electrode are located on the second surface of the substrate 100 opposite to the first surface (i.e., the back side of the sensor electrode structure E), and the first working electrode and the second working electrode are located on the first surface of the substrate 100 (i.e., the front side of the sensor electrode structure E); specifically, the first working electrode is arranged on the first surface of the substrate 100, and the second working electrode stack is arranged on the surface of the first working electrode and is separated by a dielectric layer 117; the first working electrode is closer to the front end 101 of the substrate than the second working electrode; the counter electrode and the reference electrode are arranged on the second surface of the substrate 100 opposite to the first surface, the counter electrode and the reference electrode are separated in space by a channel, and some components of the counter electrode and the reference electrode are located on the same plane, and some components are located on different planes.

[0227] The first working electrode comprises a first working electrode layer 107 located at the front end 101 of the substrate, a first working electrode wire 108 located at the middle end 102 of the substrate, and a first working electrode contact 109 located at the end 103 of the substrate; the first working electrode comprises a first sensing layer 115, and the first sensing layer 115 is located on the first working electrode layer 107; the second working electrode comprises a second working electrode layer 119 and a second working electrode wire 120 located at the middle end 102 of the substrate, and a second working electrode contact 121 located at the end 103 of the substrate; The second working electrode includes a second sensing layer 122, and the second sensing layer 122 is located on the second working electrode layer 119; the reference electrode includes a reference electrode layer 113 and a reference electrode wire 110 located at the middle end 102 of the substrate, and a reference electrode contact 112 located at the end 103 of the substrate, and the reference electrode layer 113 is arranged on the reference electrode wire 110; the counter electrode includes a counter electrode layer 104 located at the front end 101 of the substrate, a counter electrode wire 105 located at the middle end 102 of the substrate, and a counter electrode contact 106 located at the end 103 of the substrate.

[0228] The sensor electrode structure E includes a channel 114 located between the counter electrode wire 105 and the reference electrode layer 113, and the counter electrode and the reference electrode are separated by the channel 114. The width of the channel 114 is adjustable within the range of 1 μm-280 μm, and the length of the channel is adjustable within the range of 30 μm-10000 μm. The sensor electrode structure E has an L shape, including a first side and a second side, and the connection between the first side and the second side forms an angle, and the angle is 85°-95°. A protrusion structure 118 is formed at the outer edge of the connection between the first side and the second side. The sensor electrode structure E includes a protective layer 116, and the protective layer 116 is arranged on the outside of the sensor.

[0229] Fig.18 Schematic diagram of the structure of the AA' section of the sensor electrode structure E of Example 5. Fig.19 Schematic diagram of the structure of the BB' section of the sensor electrode structure E of Example 5. Fig. 20 FIG. 5 is a schematic structural diagram of the CC' section of the sensor electrode structure E of Example 5. Figure 18-Figure 20 It can be seen that the first working electrode is arranged on the first surface of the substrate 100, and the second working electrode stack is arranged on the surface of the first working electrode and separated by the dielectric layer 117; the first working electrode is closer to the front end 101 of the substrate than the second working electrode; the counter electrode and the reference electrode are arranged on the second surface of the substrate 100 opposite to the first surface, the counter electrode and the reference electrode are separated in space by a channel, and some components of the counter electrode and the reference electrode are located on the same plane, and some components are located on different planes.

[0230] Example 6

[0231] The structure of the sensor electrode structure F of Example 6 is as follows Figure 21-24 shown. Fig.21 1 is a view of the sensor electrode structure F of Example 6, wherein the left image is a back view of the sensor electrode structure F, and the right image is a front view of the sensor electrode structure F. Fig.21It can be seen that the sensor electrode structure F includes a substrate 100, a reference electrode, a counter electrode, a first working electrode and a second working electrode: the substrate 100 has an L-shaped structure, and the substrate 100 includes a front end 101, a middle end 102 and a terminal end 103; wherein, the reference electrode and the counter electrode are located on the second surface of the substrate 100 opposite to the first surface (i.e., the back side of the sensor electrode structure F), and the first working electrode and the second working electrode are located on the first surface of the substrate 100 (i.e., the front side of the sensor electrode structure F); specifically, the first working electrode and the second working electrode are arranged on the first surface of the substrate 100, the first working electrode and the second working electrode are separated in space by a channel, and all components of the first working electrode and the second working electrode are located on the same plane; the counter electrode and the reference electrode are arranged on the second surface of the substrate 100 opposite to the first surface, the counter electrode and the reference electrode are separated in space by a channel, and all components of the counter electrode and the reference electrode are located on the same plane.

[0232] The first working electrode includes a first working electrode layer 107 located at the front end 101 of the substrate, a first working electrode wire 108 located at the middle end 102 of the substrate, and a first working electrode contact 109 located at the end 103 of the substrate; the first working electrode includes a first sensing layer 115 located on the first working electrode layer 107; the second working electrode includes a second working electrode layer 119 and a second working electrode wire 120 located at the middle end 102 of the substrate, and a second working electrode contact 121 located at the end 103 of the substrate; the second working electrode includes a second sensing layer 122 located on the second working electrode layer 119; the reference electrode includes a reference electrode layer 113 and a reference electrode wire 110 located at the middle end 102 of the substrate, and a reference electrode contact 112 located at the end 103 of the substrate, and the reference electrode layer 113 is arranged on the reference electrode wire 110; the counter electrode includes a counter electrode layer 104 located at the front end 101 of the substrate, a counter electrode wire 105 located at the middle end 102 of the substrate, and a counter electrode contact 106 located at the end 103 of the substrate.

[0233] The sensor electrode structure F includes a channel 114 located between the counter electrode wire 105 and the reference electrode layer 113, and the counter electrode and the reference electrode are separated by the channel 114, the width of the channel 114 is adjustable within the range of 1μm-280μm, and the length of the channel is adjustable within the range of 30μm-10000μm. The sensor electrode structure F also includes a channel 114 located between the first working electrode wire 108 and the second working electrode layer 119, and the first working electrode and the second working electrode are separated by the channel 114, the width of the channel 114 is adjustable within the range of 1μm-280μm, and the length of the channel is adjustable within the range of 30μm-10000μm. The sensor electrode structure F has an L shape, including a first side and a second side, and the connection between the first side and the second side forms an angle, and the angle is 85°-95°. A protrusion structure 118 is formed at the outer edge of the connection between the first side and the second side. The sensor electrode structure F includes a protection layer 116 , which is disposed on the outside of the sensor.

[0234] Fig. 22 Schematic diagram of the structure of the AA' section of the sensor electrode structure F of Example 6. Fig.23 Schematic diagram of the structure of the BB' section of the sensor electrode structure F of Example 6. Fig.24 FIG. 1 is a schematic structural diagram of the CC' section of the sensor electrode structure F of Example 6. Figure 22-Figure 24 It can be seen that the first working electrode and the second working electrode are arranged on the first surface of the substrate 100, the first working electrode and the second working electrode are separated in space by a channel, and all components of the first working electrode and the second working electrode are located on the same plane; the counter electrode and the reference electrode are arranged on the second surface of the substrate 100 opposite to the first surface, the counter electrode and the reference electrode are separated in space by a channel, and all components of the counter electrode and the reference electrode are located on the same plane.

[0235] Example 7

[0236] The structure of the sensor electrode structure G of Example 7 is as follows Figure 25-28 shown. Fig.25 1 is a view of the sensor electrode structure G of Example 7, wherein the left figure is a back view of the sensor electrode structure G, and the right figure is a front view of the sensor electrode structure G. Fig.25It can be seen that the sensor electrode structure G includes a substrate 100, a reference electrode, a counter electrode, a first working electrode and a second working electrode: the substrate 100 has an L-shaped structure, and the substrate 100 includes a front end 101, a middle end 102 and a terminal end 103; wherein, the reference electrode and the first working electrode are located on the second surface of the substrate 100 opposite to the first surface (i.e., the back side of the sensor electrode structure G), and the counter electrode and the second working electrode are located on the first surface of the substrate 100 (i.e., the front side of the sensor electrode structure G); specifically, the first working electrode and the reference electrode are arranged on the first surface of the substrate 100, the first working electrode and the reference electrode are separated in space by a channel, and all components of the first working electrode and the reference electrode are located on the same plane; the counter electrode and the second working electrode are arranged on the second surface of the substrate 100 opposite to the first surface, the counter electrode and the second working electrode are separated in space by a channel, and all components of the counter electrode and the second working electrode are located on the same plane.

[0237] The first working electrode includes a first working electrode layer 107 located at the front end 101 of the substrate, a first working electrode wire 108 located at the middle end 102 of the substrate, and a first working electrode contact 109 located at the end 103 of the substrate; the first working electrode includes a first sensing layer 115 located on the first working electrode layer 107; the second working electrode includes a second working electrode layer 119 located at the front end 101 of the substrate, a second working electrode wire 120 located at the middle end 102 of the substrate, and a second working electrode contact 121 located at the end 103 of the substrate; the second working electrode includes a second sensing layer 122 located on the second working electrode layer 119; the reference electrode includes a reference electrode layer 113 and a reference electrode wire 110 located at the middle end 102 of the substrate, and a reference electrode contact 112 located at the end 103 of the substrate, and the reference electrode layer 113 is arranged on the reference electrode wire 110; the counter electrode includes a counter electrode layer 104 and a counter electrode wire 105 located at the middle end 102 of the substrate, and a counter electrode contact 106 located at the end 103 of the substrate.

[0238] The sensor electrode structure G includes a channel 114 located between the first working electrode wire 108 and the reference electrode layer 113, and the first working electrode and the reference electrode are separated by the channel 114, the width of the channel 114 is adjustable within the range of 1μm-280μm, and the length of the channel is adjustable within the range of 30μm-10000μm. The sensor electrode structure G includes a channel 114 located between the second working electrode wire 120 and the counter electrode layer 104, and the second working electrode and the counter electrode are separated by the channel 114, the width of the channel 114 is adjustable within the range of 1μm-280μm, and the length of the channel is adjustable within the range of 30μm-10000μm. The sensor electrode structure G has an L shape, including a first side and a second side, and the connection between the first side and the second side forms an angle, and the angle is 85°-95°. A protrusion structure 118 is formed at the outer edge of the connection between the first side and the second side. The sensor electrode structure G includes a protective layer 116 , which is disposed on the outside of the sensor.

[0239] Fig.26 Schematic diagram of the structure of the AA' section of the sensor electrode structure G of Example 7. Fig. 27 Schematic diagram of the structure of the BB' section of the sensor electrode structure G of Example 7. Fig.28 FIG. 1 is a schematic structural diagram of the CC' section of the sensor electrode structure G of Example 7. Figure 26-Figure 28 It can be seen that the first working electrode and the reference electrode are arranged on the first surface of the substrate 100, the first working electrode and the reference electrode are spatially separated by a channel, and all components of the first working electrode and the reference electrode are located on the same plane; the counter electrode and the second working electrode are arranged on the second surface of the substrate 100 opposite to the first surface, the counter electrode and the second working electrode are spatially separated by a channel, and all components of the counter electrode and the second working electrode are located on the same plane.

[0240] Example 8

[0241] The structure of the sensor electrode structure H of Example 8 is as follows Figure 29-Figure 32 shown. Fig.29 1 is a view of the sensor electrode structure H of Example 8, wherein the left image is a second-layer view of the back side of the sensor electrode structure H, the second left image is a first-layer view of the back side of the sensor electrode structure H, the right image is a first-layer view of the front side of the sensor electrode structure H, and the second right image is a second-layer view of the front side of the sensor electrode structure H. Fig.29It can be seen that the sensor electrode structure H includes a substrate 100, a reference electrode, a counter electrode, a first working electrode and a second working electrode: the substrate 100 has an L-shaped structure, and the substrate 100 includes a front end 101, a middle end 102 and a terminal end 103; wherein, the counter electrode and the first working electrode are located on the second surface of the substrate 100 opposite to the first surface (i.e., the back side of the sensor electrode structure H), and the reference electrode and the second working electrode are located on the first surface of the substrate 100 (i.e., the front side of the sensor electrode structure H); specifically, the reference electrode and the second working electrode are located on the first surface of the substrate 100, the reference electrode and the second working electrode are separated in space by a channel, and some components of the reference electrode and the second working electrode are located on the same plane, and some components are located on different planes; the counter electrode and the first working electrode are located on the second surface of the substrate 100 opposite to the first surface, the counter electrode and the first working electrode are separated in space by a channel, and some components of the counter electrode and the first working electrode are located on the same plane, and some components are located on different planes.

[0242] The first working electrode includes a first working electrode layer 107 located at the front end 101 of the substrate, a first working electrode wire 108 located at the middle end 102 of the substrate, and a first working electrode contact 109 located at the end 103 of the substrate; the first working electrode includes a first sensing layer 115 located on the first working electrode layer 107; the second working electrode includes a second working electrode layer 119 located at the front end 101 of the substrate, a second working electrode wire 120 located at the middle end 102 of the substrate, and a second working electrode contact 121 located at the end 103 of the substrate; the second working electrode includes a second sensing layer 122 located on the second working electrode layer 119; the reference electrode includes a reference electrode layer 113 and a reference electrode wire 110 located at the middle end 102 of the substrate, and a reference electrode contact 112 located at the end 103 of the substrate, and the reference electrode layer 113 is arranged on the reference electrode wire 110; the counter electrode includes a counter electrode layer 104 and a counter electrode wire 105 located at the middle end 102 of the substrate, and a counter electrode contact 106 located at the end 103 of the substrate.

[0243] The sensor electrode structure H includes a channel 114 located between the first working electrode wire 108 and the counter electrode layer 104, and the first working electrode and the counter electrode are separated by the channel 114, the width of the channel 114 is adjustable within the range of 1μm-280μm, and the length of the channel is adjustable within the range of 30μm-10000μm. The sensor electrode structure H includes a channel 114 located between the second working electrode wire 120 and the reference electrode layer 113, and the second working electrode and the reference electrode are separated by the channel 114, the width of the channel 114 is adjustable within the range of 1μm-280μm, and the length of the channel is adjustable within the range of 30μm-10000μm. The sensor electrode structure H has an L shape, including a first side and a second side, and the connection between the first side and the second side forms an angle, and the angle is 85°-95°. A protrusion structure 118 is formed at the outer edge of the connection between the first side and the second side. The sensor electrode structure H includes a protection layer 116 , which is disposed on the outside of the sensor.

[0244] Fig.30 Schematic diagram of the structure of the AA' section of the sensor electrode structure H of Example 8. Fig.31 Schematic diagram of the structure of the BB' section of the sensor electrode structure H of Example 8. Fig.32 FIG. 1 is a schematic structural diagram of the CC' section of the sensor electrode structure H of Example 8. Figure 29-Figure 32 It can be seen that the reference electrode and the second working electrode are located on the first surface of the substrate 100, the reference electrode and the second working electrode are separated in space by a channel, and some components of the reference electrode and the second working electrode are located on the same plane, and some components are located on different planes; the counter electrode and the first working electrode are located on the second surface of the substrate 100 opposite to the first surface, the counter electrode and the first working electrode are separated in space by a channel, and some components of the counter electrode and the first working electrode are located on the same plane, and some components are located on different planes.

[0245] Example 9

[0246] The structure of the sensor electrode structure I of Example 9 is as follows Figure 33-Figure 36 shown. Fig.33 1 is a view of the sensor electrode structure I of Example 8, wherein the left image is a second-layer view of the back side of the sensor electrode structure I, the second left image is a first-layer view of the back side of the sensor electrode structure I, the right image is a first-layer view of the front side of the sensor electrode structure I, and the second right image is a second-layer view of the front side of the sensor electrode structure I. Fig.33As can be seen in the figure, the sensor electrode structure I includes a substrate 100, a reference electrode, a counter electrode, a first working electrode and a second working electrode: the substrate 100 has an L-shaped structure, and the substrate 100 includes a front end 101, a middle end 102 and a terminal end 103; wherein, the counter electrode and the reference electrode are located on the second surface of the substrate 100 opposite to the first surface (i.e., the back side of the sensor electrode structure I), and the first working electrode and the second working electrode are located on the first surface of the substrate 100 (i.e., the front side of the sensor electrode structure I); specifically, the first working electrode and the second working electrode are located on the first surface of the substrate 100, the first working electrode and the second working electrode are separated in space by a channel, and some components of the first working electrode and the second working electrode are located on the same plane, and some components are located on different planes; the reference electrode and the counter electrode are located on the second surface of the substrate 100 opposite to the first surface, the reference electrode and the counter electrode are separated in space by a channel, and some components of the reference electrode and the counter electrode are located on the same plane, and some components are located on different planes.

[0247] The first working electrode comprises a first working electrode layer 107 and a first working electrode wire 108 located at the middle end 102 of the substrate, and a first working electrode contact 109 located at the end 103 of the substrate; the first working electrode comprises a first sensing layer 115 located on the first working electrode layer 107; the second working electrode comprises a second working electrode layer 119 located at the front end 101 of the substrate, a second working electrode wire 120 located at the middle end 102 of the substrate, and a second working electrode contact 121 located at the end 103 of the substrate; the second working electrode comprises a first working electrode layer 119 located at the front end 101 of the substrate, a second working electrode wire 120 located at the middle end 102 of the substrate, and a second working electrode contact 121 located at the end 103 of the substrate; The working electrode includes a second sensing layer 122 located on the second working electrode layer 119; the reference electrode includes a reference electrode layer 113 and a reference electrode wire 110 located at the middle end 102 of the substrate, and a reference electrode contact 112 located at the end 103 of the substrate, and the reference electrode layer 113 is arranged on the reference electrode wire 110; the counter electrode includes a counter electrode layer 104 located at the front end 101 of the substrate, a counter electrode wire 105 at the middle end 102 of the substrate, and a counter electrode contact 106 located at the end 103 of the substrate.

[0248] The sensor electrode structure I includes a channel 114 located between the second working electrode wire 120 and the first working electrode layer 107, and the first working electrode and the second working electrode are separated by the channel 114. The width of the channel 114 is 1μm-280μm, and the length of the channel is adjustable in the range of 30μm-10000μm. The sensor electrode structure I includes a channel 114 located between the counter electrode wire 105 and the reference electrode layer 113, and the counter electrode and the reference electrode are separated by the channel 114. The width of the channel 114 is adjustable in the range of 1μm-280μm, and the length of the channel is adjustable in the range of 30μm-10000μm. The sensor electrode structure I has an L shape, including a first side and a second side, and the connection between the first side and the second side forms an angle, and the angle is 85°-95°. A protrusion structure 118 is formed at the outer edge of the connection between the first side and the second side. The sensor electrode structure I includes a protective layer 116, and the protective layer 116 is arranged on the outside of the sensor.

[0249] Fig.34 Schematic diagram of the structure of the AA' section of the sensor electrode structure I of Example 9. Fig.35 Schematic diagram of the structure of the BB' section of the sensor electrode structure I of Example 9. Fig.36 FIG. 1 is a schematic structural diagram of the CC' section of the sensor electrode structure I of Example 9. Figure 34-Figure 36 It can be seen that the first working electrode and the second working electrode are located on the first surface of the substrate 100, the first working electrode and the second working electrode are separated in space by a channel, and some components of the first working electrode and the second working electrode are located on the same plane, and some components are located on different planes; the reference electrode and the counter electrode are located on the second surface of the substrate 100 opposite to the first surface, the reference electrode and the counter electrode are separated in space by a channel, and some components of the reference electrode and the counter electrode are located on the same plane, and some components are located on different planes.

[0250] Fig.38 The diagrams are a schematic diagram of a sensor with a protruding structure and an auxiliary device (left diagram) and a schematic diagram of a sensor without a protruding structure and an auxiliary device (right diagram), wherein reference numeral 1000 is an auxiliary device and 1001 is a sensor. Fig.38 It can be seen that the sensor portion without the protrusion structure is located outside the auxiliary device.

[0251] Fig.39 A schematic diagram of the structure of the sensor surface after the sensor with protrusion structure is implanted in the human body (left picture) and a schematic diagram of the structure of the sensor surface after the sensor without protrusion structure is implanted in the human body (right picture). Fig.39 It can be seen that the sensor without a protrusion structure has damage on its surface after being implanted into the human body, while the sensor with a protrusion structure has no damage on its surface after being implanted into the human body.

[0252] Fig.40The schematic diagram of the structure of the sensor with a channel structure after being implanted into the human body (left picture) and the schematic diagram of the structure of the sensor without a channel structure (i.e., a stacked structure) after being implanted into the human body (right picture). Fig.40 It can be seen that after the sensor without a channel structure (i.e. a stacked structure) is implanted in the human body, "bloodstains" can be seen on the side of the sensor. The "bloodstains" indicate that there is obvious bleeding at the wearing position when the sensor is implanted, which affects the wearing experience from the user's perspective. The sensor with a channel structure has a more suitable thickness, so there are no obvious "bloodstains" on the side, which means that the sensor with a channel structure is smoother to wear and provides a better wearing experience.

[0253] Comparative Example 1

[0254] The other structures are as shown in Example 7, except that the width of the channel 114 in the sensor of Comparative Example 1 is less than 1 μm, which will cause the first working electrode wire to contact the reference electrode, and the first working electrode and the reference electrode are very likely to short-circuit. The change trend of blood sugar in a normal human body after implanting the sensor for one day is as follows: Fig.42 As shown. Fig.42 It can be seen that due to the narrow channel width in the sensor, a short circuit occurs between the first working electrode and the reference electrode, which leads to high blood sugar. The blood sugar reading of a normal person is generally between 3.9mM-6.1mM.

[0255] Comparative Example 2

[0256] The other structures are as shown in Example 7, except that the width of the channel 114 in the sensor of Comparative Example 2 is greater than 280 μm, which will cause the electrode / electrode wire to be too narrow, thus easily causing a circuit break. The trend of blood sugar changes after the sensor is implanted in a normal human body for 4 days is as follows: Fig.43 As shown. Fig.43 It can be seen that due to the excessive width of the channel in the sensor, the first working electrode wire is too narrow, causing the electrode to be broken, which will cause data "jumps" or "jitters" in the blood glucose test process, affecting the stability of the test data.

[0257] The above is an explanation of the embodiments of the present invention. However, the present invention is not limited to the above embodiments. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. An analyte sensor, comprising a substrate, a first working electrode, a second working electrode, a reference electrode, a counter electrode, a first sensing layer and a second sensing layer; the first sensing layer is disposed on the first working electrode, and the second sensing layer is disposed on the second working electrode; Any two of the first working electrode, the second working electrode, the reference electrode and the counter electrode are located on a first surface of the substrate, and the remaining two of the first working electrode, the second working electrode, the reference electrode and the counter electrode are located on a second surface of the substrate opposite to the first surface; Two electrodes located on a first surface of the substrate are spatially separated by a channel, and / or two electrodes located on a second surface of the substrate opposite to the first surface are spatially separated by a channel; The width of the channel is 1 μm-280 μm; the length of the channel is 30 μm-10000 μm.

2. The analyte sensor according to claim 1, wherein The first working electrode and the reference electrode are arranged on a first surface of the substrate, the counter electrode and the second working electrode are arranged on a second surface of the substrate opposite to the first surface, the first working electrode and the reference electrode are spatially separated by a channel, and / or the counter electrode and the second working electrode are spatially separated by a channel; or, The first working electrode and the counter electrode are arranged on a first surface of the substrate, the reference electrode and the second working electrode are arranged on a second surface of the substrate opposite to the first surface, the first working electrode and the counter electrode are spatially separated by a channel, and / or the reference electrode and the second working electrode are spatially separated by a channel; or, The counter electrode and the reference electrode are arranged on the first surface of the substrate, the first working electrode and the second working electrode are arranged on the second surface of the substrate opposite to the first surface, the counter electrode and the reference electrode are spatially separated by a channel, and / or the first working electrode and the second working electrode are spatially separated by a channel. Preferably, the two electrodes located on the same side of the substrate and separated in space by the channel are completely located on the same plane; or, the two electrodes located on the same side of the substrate and separated in space by the channel are partially located on the same plane.

3. An analyte sensor, comprising a substrate, a first working electrode, a second working electrode, a reference electrode, a counter electrode, a first sensing layer and a second sensing layer; the first sensing layer is disposed on the first working electrode, and the second sensing layer is disposed on the second working electrode; Any three electrodes among the first working electrode, the second working electrode, the reference electrode and the counter electrode are located on the first surface of the substrate, and the remaining electrode among the first working electrode, the second working electrode, the reference electrode and the counter electrode is located on the second surface of the substrate opposite to the first surface; One of the three electrodes located on the first surface of the substrate is disposed on the surface of the substrate, and the remaining two of the three electrodes are stacked and disposed on the surface of the one electrode and separated by a dielectric layer, and the remaining two of the three electrodes are spatially separated by a channel; The width of the channel is 1 μm-280 μm; the length of the channel is 30 μm-10000 μm.

4. The analyte sensor according to claim 3, wherein: The first working electrode, the second working electrode and the reference electrode are arranged on the first surface of the substrate, and the counter electrode is arranged on the second surface of the substrate opposite to the first surface; or, the first working electrode, the second working electrode and the counter electrode are arranged on the first surface of the substrate, and the reference electrode is arranged on the second surface of the substrate opposite to the first surface; or, the first working electrode, the counter electrode and the reference electrode are arranged on the first surface of the substrate, and the second working electrode is arranged on the second surface of the substrate opposite to the first surface; or, the second working electrode, the counter electrode and the reference electrode are arranged on the first surface of the substrate, and the first working electrode is arranged on the second surface of the substrate opposite to the first surface. Preferably, any two electrodes of the three electrodes spatially separated by channels located on the same side of the substrate may be completely located on the same plane; or, any two electrodes of the three electrodes spatially separated by channels located on the same side of the substrate may be partially located on the same plane.

5. The analyte sensor according to any one of claims 1 to 4, wherein: The substrate comprises a front end, a middle end and a terminal end, and the front end, the middle end and the terminal end are sequentially connected and arranged; the substrate has an L shape, and the L shape comprises a first side and a second side, and a connection between the first side and the second side forms an angle, and the angle is 45°-135°; the front end is located on the first side and at a non-connected end of the first side, the terminal end is located on the second side and at a non-connected end of the second side, and the middle end is located on the first side and the second side, and at a connected end of the first side and a connected end of the second side.

6. The analyte sensor according to any one of claims 1 to 5, wherein: The first working electrode comprises a first working electrode layer, a first working electrode wire and a first working electrode contact, wherein the first working electrode layer is connected to the first working electrode contact via the first working electrode wire; the first working electrode layer is located at the front end of the substrate, the first working electrode wire is located at the middle end of the substrate, and the first working electrode contact is located at the end of the substrate; or, the first working electrode layer and the first working electrode wire are located at the middle end of the substrate, and the first working electrode contact is located at the end of the substrate; The second working electrode comprises a second working electrode layer, a second working electrode wire and a second working electrode contact, wherein the second working electrode layer is connected to the second working electrode contact via the second working electrode wire; the second working electrode layer is located at the front end of the substrate, the second working electrode wire is located at the middle end of the substrate, and the second working electrode contact is located at the end of the substrate; or, the second working electrode layer and the second working electrode wire are located at the middle end of the substrate, and the second working electrode contact is located at the end of the substrate; The reference electrode comprises a reference electrode layer, a reference electrode wire and a reference electrode contact, wherein the reference electrode layer is arranged on the reference electrode wire, and the reference electrode wire is connected to the reference electrode contact; the reference electrode layer is located at the front end of the substrate, the reference electrode wire is located at the front end and the middle end of the substrate, and the reference electrode contact is located at the end of the substrate; or, the reference electrode layer and the reference electrode wire are located at the middle end of the substrate, and the reference electrode contact is located at the end of the substrate; The counter electrode includes a counter electrode layer, a counter electrode wire and a counter electrode contact, wherein the counter electrode layer is connected to the counter electrode contact via the counter electrode wire; the counter electrode layer is located at the front end of the substrate, the counter electrode wire is located at the middle end of the substrate, and the counter electrode contact is located at the end of the substrate; or, the counter electrode layer and the counter electrode wire are located at the middle end of the substrate, and the counter electrode contact is located at the end of the substrate. Preferably, the counter electrode forms a current closed loop with the first working electrode to provide a guarantee for converting the first analyte signal into an electrochemical signal, and simultaneously forms a current closed loop with the second working electrode to provide a guarantee for converting the second analyte signal into an electrochemical signal; The reference electrode forms a voltage loop with the first working electrode to provide a guarantee for converting the first analyte signal into an electrochemical signal, and at the same time forms a voltage loop with the second working electrode to provide a guarantee for converting the second analyte signal into an electrochemical signal.

7. The analyte sensor according to any one of claims 1 to 6, wherein: A second sensing layer is arranged on the second working electrode layer, and the second working electrode mainly plays a role of reacting with a second analyte; a first sensing layer is arranged on the first working electrode layer, and the first working electrode mainly plays a role of reacting with a first analyte; The thickness of the first working electrode layer is 1 μm-20 μm; the thickness of the second working electrode layer is 1 μm-20 μm; The analyte / physiological index that the first sensing layer can monitor is blood sugar; the analyte / physiological index that the second sensing layer can monitor includes uric acid, lactic acid, blood ketones, cholesterol, triglycerides, heart rate, blood pressure, Na + ,Ka + , Ga 2+ , Fe 2+ and Mg 2+ One of the above.

8. The analyte sensor according to any one of claims 1 to 7, wherein: Two electrodes that are spatially separated by a channel means that an electrode layer of one electrode and an electrode wire of the other electrode are spatially separated by a channel. Preferably, the width of the channel may be fixed or gradually varying.

9. The analyte sensor according to any one of claims 1 to 8, wherein: The analyte sensor has an L-shape, wherein the L-shape includes a first side and a second side, and a connection between the first side and the second side forms an angle, and the angle is 45°-135°. Preferably, the first surface of the analyte sensor has two contact areas and two electrode areas, the second surface of the analyte sensor opposite to the first surface has one contact area and one electrode area, the electrode area is arranged on a first side of the L-shaped sensor, and the contact area is arranged on a second side of the sensor; or, The first surface of the analyte sensor has two contact areas and two electrode areas, and the second surface of the analyte sensor opposite to the first surface has two contact areas and two electrode areas; or, The first surface of the analyte sensor has three contact areas and three electrode areas, and the second surface of the analyte sensor opposite to the first surface has one contact area and one electrode area, the electrode area is arranged on the first side of the L-shaped sensor, and the contact area is arranged on the second side of the sensor.

10. The analyte sensor according to any one of claims 1 to 9, wherein: A protrusion structure is formed at the connection between the first side and the second side. Preferably, an outer edge of a connection between the first side and the second side forms a protrusion structure.

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