Analyte sensor based on monitoring plurality of analytes

Abstract

The present invention provides an analyte sensor based on monitoring a plurality of analytes. The analyte sensor comprises a channel structure. The analyte sensor, after being implanted into a human body, can achieve simultaneous monitoring of a plurality of analytes. The analyte sensor is characterized by good flexibility, a small size, coexistence of a plurality of analysis modes, low manufacturing costs, a simple process flow, and long-term monitoring. The analyte sensor has the function of simultaneously monitoring analytes / indicators, and the analyte sensor can simultaneously realize the characteristics of two functional regions in one plane. The introduction of the channel structure of the present invention enables the thickness of the analyte sensor to be more suitable and the wearing experience to be better. In addition, the introduction of the channel structure can avoid the occurrence of problems such as poor stability of the sensor caused by unstable signal transmission due to a small electrode area or an excessively narrow electrode wire.

Description

[0001] Analyte sensor based on monitoring multiple analytes

[0002] Technical Field

[0003] This invention belongs to the field of sensor technology, specifically relating to an analytical sensor based on monitoring multiple analytes.

[0004] Background Technology

[0005] Flexible electrodes are electrodes manufactured using flexible substrates. Biosensors made from flexible electrodes are characterized by their light weight, high flexibility, stretchability, and excellent comfort. Biosensors made from flexible electrodes are widely used in the detection of nucleic acids, proteins, glucose, bacteria, toxins, cells, and pesticides in vitro.

[0006] Currently, flexible electrodes are mostly used for temporary in vitro detection. However, with increasing demand, there is a growing need for sensors capable of continuously monitoring analytes in vivo. However, current flexible electrodes are relatively large, failing to meet the human body's adaptability to sensors. Furthermore, the complex manufacturing process and high cost of these sensors further limit their development.

[0007] Summary of the Invention

[0008] To address the shortcomings of existing technologies, this invention provides an analytical sensor for monitoring multiple analytes. Once implanted in the human body, the analytical sensor can simultaneously monitor multiple analytes. The sensor is characterized by its flexibility, small size, ability to support multiple analytical methods, low manufacturing cost, simple process, and long-term monitoring capability.

[0009] The objective of this invention is achieved through the following technical solution:

[0010] An analyte sensor includes 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, second working electrode, reference electrode, and counter electrode are located on a first surface of the substrate, and the remaining two of the first working electrode, second working electrode, reference electrode, and counter electrode are located on a 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 1 μm to 280 μm, and the length of the channel is 30 μm to 10000 μm.

[0011] An analyte sensor includes 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 of the first, second, reference, and counter electrodes are located on a first surface of the substrate, and the remaining electrode is located on a 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 substrate surface, and the remaining two electrodes are stacked on the surface of the first electrode and separated by a dielectric layer. The remaining two electrodes are spatially separated by a channel. The width of the channel is 1gm-280gm, and the length of the channel is 30gm-10000gm. o

[0012] The beneficial effects of this invention are:

[0013] This invention provides an analytical sensor for monitoring multiple analytes. The analytical sensor contains a channel structure and can be implanted in the human body to simultaneously monitor multiple analytes. The sensor is characterized by high flexibility, small size, compatibility with multiple analysis methods, low manufacturing cost, simple process, and long-term monitoring capability. The analytical sensor has the function of simultaneously monitoring analytes / indicators, the ability to support multiple analysis methods, implantability, continuous monitoring, low manufacturing cost, simple process, small size, and high flexibility. Furthermore, the sensor can simultaneously realize two functional areas within a single plane. The introduction of the channel structure in this invention makes the thickness of the analytical sensor more suitable and improves the wearing experience. Simultaneously, the introduction of the channel structure avoids problems such as unstable signal transmission caused by small electrode area or excessively narrow electrode wires, which can lead to poor sensor stability.

[0014] Attached Figure Description

[0015] Figure 1 is a view of the sensor electrode structure A of Embodiment 1.

[0016] Figure 2 is a schematic diagram of the A-A' section of the sensor electrode structure A in Example 1.

[0017] Figure 3 is a schematic diagram of the B-B' section of the sensor electrode structure A in Example 1.

[0018] Figure 4 is a schematic diagram of the CC' section of the sensor electrode structure A in Example 1.

[0019] Figure 5 is a view of sensor electrode structure B in Example 2.

[0020] Figure 6 is a schematic diagram of the sensor electrode structure B of Example 2 along the A-A' section.

[0021] Figure 7 is a schematic diagram of the B-B' section of the sensor electrode structure B in Example 2.

[0022] Figure 8 is a schematic diagram of the C-C' section of the sensor electrode structure B in Example 2.

[0023] Figure 9 is a view of the sensor electrode structure C of Example 3.

[0024] Figure 10 is a schematic diagram of the A-A' section of the sensor electrode structure C in Example 3.

[0025] Figure 11 is a schematic diagram of the B-B' section of the sensor electrode structure C in Example 3.

[0026] Figure 12 is a schematic diagram of the C-C' cross section of the sensor electrode structure C in Example 3.

[0027] Figure 13 is a view of the sensor electrode structure D of Example 4.

[0028] Figure 14 is a schematic diagram of the sensor electrode structure D of Example 4 along the A-A' section.

[0029] Figure 15 is a schematic diagram of the B-B' section of the sensor electrode structure D in Example 4.

[0030] Figure 16 is a schematic diagram of the C-C' section of the sensor electrode structure D in Example 4.

[0031] Figure 17 is a view of the sensor electrode structure E of Example 5.

[0032] Figure 18 is a schematic diagram of the sensor electrode structure E of Example 5 along the A-A' section.

[0033] Figure 19 is a schematic diagram of the B-B' section of the sensor electrode structure E in Example 5.

[0034] Figure 20 is a schematic diagram of the C-C' section of the sensor electrode structure E in Example 5.

[0035] Figure 21 is a view of the sensor electrode structure F of Embodiment 6.

[0036] Figure 22 is a schematic diagram of the A-A' section of the sensor electrode structure F in Example 6.

[0037] Figure 23 is a schematic diagram of the B-B' section of the sensor electrode structure F in Example 6.

[0038] Figure 24 is a schematic diagram of the C-C' section of the sensor electrode structure F in Example 6.

[0039] Figure 25 is a view of the sensor electrode structure G of Example 7.

[0040] Figure 26 is a schematic diagram of the sensor electrode structure G of Example 7, with section A-A'.

[0041] Figure 27 is a schematic diagram of the sensor electrode structure G of Example 7 along its B-B' cross section. Figure 28 is a schematic diagram of the sensor electrode structure G of Example 7 along its C-C' cross section.

[0042] Figure 29 is a view of the sensor electrode structure H of Example 8.

[0043] Figure 30 is a schematic diagram of the sensor electrode structure H of Example 8 along the A-A' section.

[0044] Figure 31 is a schematic diagram of the B-B' section of the sensor electrode structure H in Example 8.

[0045] Figure 32 is a schematic diagram of the C-C' cross section of the sensor electrode structure H in Example 8.

[0046] Figure 33 is a view of sensor electrode structure I of Example 9.

[0047] Figure 34 is a schematic diagram of the sensor electrode structure I of Example 9 along the A-A' section.

[0048] Figure 35 is a schematic diagram of the B-B' section of the sensor electrode structure I in Example 9.

[0049] Figure 36 is a schematic diagram of the C-C' section of the sensor electrode structure I in Example 9.

[0050] Figure 37 is a partial view of the protrusion position of the sensor of the present invention.

[0051] Figure 38 shows a schematic diagram of the combination of a sensor and an auxiliary device with a protruding structure (left) and a schematic diagram of the combination of a sensor and an auxiliary device without a protruding structure (right), where reference numeral 1000 represents the auxiliary device and 1001 represents the sensor.

[0052] Figure 39 shows a schematic diagram of the sensor surface after the sensor with protrusions is implanted into the human body (left) and a schematic diagram of the sensor surface after the sensor without protrusions is implanted into the human body (right).

[0053] Figure 40 shows a schematic diagram of the sensor structure after implantation into the human body with a channel structure (left) and a schematic diagram of the sensor structure after implantation into the human body without a channel structure (i.e., a stacked structure) (right).

[0054] Figure 41 is a partial enlarged view of the sensor according to a preferred embodiment of the present invention.

[0055] Figure 42 shows the trend of blood glucose monitoring by the first working electrode of the sensor electrode structure of Comparative Example 1 after one day of implantation in the human body.

[0056] Figure 43 shows the trend of blood glucose monitoring by the first working electrode of the sensor electrode structure of Comparative Example 2 after 4 days of implantation in the human body.

[0057] Detailed Implementation

[0058] <Analyte Sensor>

[0059] As previously stated, 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.

[0060] 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.

[0061] The width of the channel is 1 gm-280 gm; the length of the channel is 30 gm-10000 gm...

[0062] According to an embodiment of the present invention, any two of the first working electrode, second working electrode, reference electrode, and counter electrode are located on the first surface of the substrate, and the remaining two of the first working electrode, second working electrode, reference electrode, and 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. This structural arrangement allows the first surface of the sensor to have two functionally different functional regions / electrode regions, and / or the second surface of the sensor opposite to the first surface to have two functionally different functional regions / electrode regions, and the two functionally different functional regions / electrode regions are spatially separated by a channel, so they do not affect each other. This allows the two functionally different functional regions / electrode regions to function on the same side of the sensor, effectively reducing the risk of sensor failure due to contact between the two functionally different functional regions / electrode regions. Moreover, this structural arrangement ensures that the functional regions / electrode regions of the sensor have sufficient area, thereby enabling the sensor to have good stability during long-term monitoring, and effectively avoiding the first working electrode, second working electrode, When the reference electrode and counter electrode are located on the same surface, short circuits and open circuits can occur due to the limited implantation width of the sensor itself, resulting in small electrode areas and narrow electrode wires. Furthermore, the structural arrangement of two functionally distinct regions / electrode regions on the same side of the sensor surface simplifies the sensor fabrication process, especially compared to sensors designed with a stacked structure (i.e., any two electrodes are spatially arranged vertically and separated by a dielectric layer; this stacked structure increases the manufacturing process and difficulty, and the thickness also affects the wearing experience). The arrangement of two functionally distinct regions / electrode regions on the same side of the sensor also ensures that the resulting sensor has better flexibility, smaller size, lower cost, and better wearing comfort. Moreover, due to the reference electrode, the analyte sensor can monitor the analyte for a long period after implantation.

[0063] 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 disposed on both sides of the substrate, forming a structure in which two types of electrodes are disposed on the first surface of the substrate and two types of electrodes are disposed on the second surface of the substrate opposite to the first surface; wherein, the two types of electrodes disposed 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 types of electrodes disposed on the second surface of the substrate opposite to the first surface refer to the remaining two types of electrodes other than the two types of electrodes mentioned above.

[0064] According to an embodiment of the present invention, a first working electrode and a reference electrode are disposed on a first surface of a substrate, and a counter electrode and a second working electrode are disposed on a second surface of the substrate opposite to the first surface; or a first working electrode and a counter electrode are disposed on a first surface of a substrate, and a reference electrode and a second working electrode are disposed on a second surface of the substrate opposite to the first surface; or a counter electrode and a reference electrode are disposed on a first surface of a substrate, and a first working electrode and a second working electrode are disposed on a second surface of the substrate opposite to the first surface.

[0065] According to an embodiment of the present invention, a first working electrode and a reference electrode are disposed on a first surface of a substrate, and a counter electrode and a second working electrode are disposed 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,

[0066] A first working electrode and a counter electrode are disposed on a first surface of the substrate, and a reference electrode and a second working electrode are disposed 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...

[0067] The counter electrode and the reference electrode are disposed on a first surface of the substrate, and the first working electrode and the second working electrode are disposed on a 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.

[0068] According to an embodiment of the present invention, a first working electrode and a reference electrode are disposed on a first surface of a substrate, and a counter electrode and a second working electrode are disposed 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 top of each other 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 top of each other 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. According to an embodiment of the present invention, a first working electrode and a counter electrode are disposed on a first surface of a substrate, and a reference electrode and a second working electrode are disposed 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 top of each other 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 top of each other 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. According to an embodiment of the present invention, a counter electrode and a reference electrode are disposed on a first surface of a substrate, and a first working electrode and a second working electrode are disposed on a 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 top of each other 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 top of each other 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. According to an embodiment of the present invention, the two electrodes located on the same side of the substrate and spatially separated by a channel are completely located on the same plane; exemplaryly, the electrode layers, electrode wires, and electrode contacts of the two electrodes are all located on the same plane.

[0069] According to embodiments 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; exemplaryly, 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.

[0070] According to an embodiment of the present invention, two electrodes stacked on the same side of the substrate are not located on the same plane and are separated by a dielectric layer; exemplarily, 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.

[0071] According to an embodiment of the present invention, two electrodes located on the same side of the substrate and spatially separated by a channel are not stacked on top of each other.

[0072] <Analyte Sensor>

[0073] 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;

[0074] Any three of the following electrodes—a first working electrode, a second working electrode, a reference electrode, and a counter electrode—are located on a first surface of the substrate; the remaining electrode is located on a 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 substrate surface, and the remaining two electrodes are stacked on the surface of the first electrode and separated by a dielectric layer. The remaining two electrodes are spatially separated by a channel; the width of the channel is 1 μm to 280 μm; the length of the channel is 30 μm to 10000 μm…

[0075] According to an embodiment of the present invention, any three of the following electrodes—a first working electrode, a second working electrode, a reference electrode, and a counter electrode—are located on a first surface of a substrate. The remaining electrode is located on a second surface of the substrate opposite to the first surface. One of the three electrodes located on the first surface is disposed on the substrate surface, and the remaining two electrodes are stacked on the surface of the first electrode and separated by a dielectric layer. The remaining two electrodes are spatially separated by a channel. This structural arrangement allows the first surface of the sensor to have three functional regions / electrode regions with different functions, and the second surface of the sensor opposite to the first surface to have one functional region / electrode region. The functional regions / electrode regions with different functions are spatially separated by a channel and do not interfere with each other. This allows the functional regions / electrode regions with different functions to function on the same side surface of the sensor. This design effectively reduces the risk of sensor failure due to contact between functional / electrode regions with different functions. Furthermore, this structural arrangement ensures sufficient area for the sensor's functional / electrode regions, resulting in good stability during long-term monitoring. It effectively avoids short circuits and open circuits caused by the limited implantation width of the sensor itself, leading to insufficient area of ​​each electrode and narrow electrode wires when the first working electrode, second working electrode, reference electrode, and counter electrode are placed on the same surface. In addition, the structural arrangement of functional / electrode regions on the same side of the sensor simplifies the sensor fabrication process, especially compared to sensors designed with a stacked structure (i.e., any three electrodes are spatially arranged vertically and separated by a dielectric layer; this stacked structure increases the manufacturing process and difficulty, and the thickness affects the wearing experience). The structural arrangement of functional / electrode regions on the same side of the sensor also ensures that the resulting sensor has better flexibility, smaller size, lower cost, and better wearing comfort. Moreover, due to the reference electrode, the analyte sensor can monitor analytes for a long period after implantation.

[0076] 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 disposed on both sides of the substrate, forming a structure in which the first surface of the substrate is provided with three types of electrodes, and the second surface of the substrate opposite to the first surface is provided with one type of electrode; wherein, the three types of electrodes disposed 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; the one type of electrode disposed on the second surface of the substrate opposite to the first surface refers to the remaining type of electrode other than the above three types of electrodes.

[0077] According to embodiments of the present invention, a first working electrode, a second working electrode, and a reference electrode are disposed on a first surface of a substrate, and a counter electrode is disposed on a second surface of the substrate opposite to the first surface; or, the first working electrode, the second working electrode, and the counter electrode are disposed on the first surface of the substrate, and the reference electrode is disposed 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 disposed on the first surface of the substrate, and the second working electrode is disposed 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 disposed on the first surface of the substrate, and the first working electrode is disposed on the second surface of the substrate opposite to the first surface.

[0078] According to an embodiment of the present invention, a first working electrode, a second working electrode, and a reference electrode are disposed on a first surface of a substrate, and a counter electrode is disposed on a second surface of the substrate opposite to the first surface; wherein, the first working electrode is disposed on the substrate surface, the second working electrode and the reference electrode are respectively stacked 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 more 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 disposed on the substrate surface, the first working electrode and the reference electrode are respectively stacked 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 more 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 disposed on the substrate surface, the first working electrode and the second working electrode are respectively stacked 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 more preferably, the reference electrode is closer to the front end 101 of the substrate than the first working electrode and the second working electrode.

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

[0081] According to an embodiment of the present invention, any two of the three electrodes located on the same side of the substrate and spatially separated by a channel can be located entirely on the same plane; exemplary, the electrode layers, electrode wires and electrode contacts of any two electrodes are all located on the same plane.

[0082] According to embodiments of the present invention, any two of three electrodes spatially separated by channels on the same side of the substrate may be partially located on the same plane. Exemplarily, the electrode layers of any 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 any 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 any 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 any 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 any 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 any two electrodes are not located on the same plane, but the electrode contacts of the two electrodes are located on the same plane.

[0083] According to an embodiment of the present invention, any two electrodes located on the same side of the substrate and spatially separated by a channel are not stacked on top of each other. <Substrate Structure and Composition>

[0084] According to an embodiment of the present invention, the substrate 100 includes a front end 101, a middle end 102 and a rear end 103, which are sequentially connected.

[0085] According to an embodiment of the present invention, the substrate 100 has an L-shape, the L-shape including a first side and a second side, and the connection between the first side and the second side forms an included angle, the included angle being 45°-135°, preferably 88°-98°, such as 90°, 92°, 93°, 94°, 95°, 96°, or 97°. 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 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, at the connection end of the first side and the connection end of the second side. The connection end refers to the end closer to the connection between the first side and the second side, and the non-connected end refers to the end farther away from the connection between the first side and the second side.

[0086] According to embodiments of the present invention, the material forming the substrate includes at least one of plastics (such as polyethylene terephthalate PET, polyimide PI, polyvinyl chloride PVC or polyethylene PE), polydimethylsiloxane PDMS, ceramics, glass, paper and textiles.

[0087] 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 20gm-5000gm; 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 50gm-2000gm; exemplaryly, 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.

[0088] <Structure and Composition of Working Electrode>

[0089] 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, wherein the first working electrode layer 107 is connected to the first working electrode contact 109 through the first working electrode wire 108.

[0090] For example, 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 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 end 103 of the substrate.

[0091] According to an embodiment of the present invention, a first sensing layer 115 is provided on the first working electrode layer 107, and the first working electrode mainly functions to react with the first analyte.

[0092] 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. The second working electrode layer 119 is connected to the second working electrode contact 121 through the second working electrode wire 120.

[0093] For example, 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 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 end 103 of the substrate.

[0094] 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 serves to react with the second analyte.

[0095] According to embodiments 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 that have catalytic / signal conversion functions. Exemplarily, the noble metals include gold and its composite materials, and pin and its composite materials; the transition metals include copper and its composite materials, arsenic and its composite materials, cobalt and its composite materials, zinc and its composite materials, iridium and its composite materials, etc.

[0096] According to embodiments of the present invention, the working electrode is modified onto the substrate by processes including but not limited to printing, inkjet printing, electrochemical inkjet printing (EHD), dispensing, spraying, chemical vapor deposition (CVD), physical vapor deposition (PVD), magnetron sputtering, molecular beam epitaxy, electrochemical deposition, electroplating, and evaporation.

[0097] According to embodiments of the present invention, the materials used to form the first working electrode and the materials used to form the second working electrode may be the same or different. According to embodiments of the present invention, the methods for preparing the first working electrode and the methods for preparing the second working electrode may be the same or different. According to embodiments of the present invention, the thickness of the first working electrode layer is 1gm-20gm, preferably 5gm-15gm, for example, 2gm, 3gm, 4gm, 5gm, 6gm, 7gm, 8gm, 9gm, 10gm, 11gm, 12gm, 15gm, or 18gm.

[0098] According to an embodiment of the present invention, the thickness of the second working electrode layer is 1gm-20gm, preferably 5gm-15gm, for example 2gm, 3gm, 4gm, 5gm, 6gm, 7gm, 8gm, 9gm, 10gm, 11gm, 12gm, 15gm or 18gm.

[0099] 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 may be the same or different.

[0100] <Structure and Composition of Reference Electrode>

[0101] 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. 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.

[0102] For example, 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; or, 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.

[0103] According to an embodiment of the present invention, the reference electrode forms a voltage loop with the first working electrode to ensure the conversion of the first analyte signal into an electrochemical signal, and simultaneously forms a voltage loop with the second working electrode to ensure the conversion of the second analyte signal into an electrochemical signal. The reference electrode stabilizes the potential, thus enabling the analyte sensor to perform continuous and stable monitoring. According to an embodiment of the present invention, the materials forming the reference electrode include Ag and AgCl, wherein the mass ratio of Ag to AgCl is 1:10-10:1, preferably 2:8-8:2, for example 3:7, 4:6, 5:5, 6:4, 7:3, etc.

[0104] According to embodiments of the present invention, a reference electrode is modified onto a substrate by means of processes including but not limited to printing, inkjet printing, electrochemical inkjet printing (EHD), dispensing, spraying, chemical vapor deposition (CVD), physical vapor deposition (PVD), magnetron sputtering, molecular beam epitaxy, electrochemical deposition, electroplating, and evaporation.

[0105] According to an embodiment of the present invention, the thickness of the reference electrode layer is 0.1 gm-500 gm, preferably 1 gm-200 gm, such as 5 gm, 10 gm, 15 gm, 20 gm, 50 gm, 80 gm, 90 gm, 100 gm, 120 gm, 150 gm, 180 gm or 200 gm.

[0106] <Structure and Composition of Counter Electrode>

[0107] 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, wherein the counter electrode layer 104 is connected to the counter electrode contact 106 via the counter electrode wire 105.

[0108] For example, 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.

[0109] According to an embodiment of the present invention, the counter electrode forms a closed current loop with the first working electrode to ensure the conversion of the first analyte signal into an electrochemical signal, and simultaneously forms a closed current loop with the second working electrode to ensure the conversion of the second analyte signal into an electrochemical signal.

[0110] According to embodiments of the present invention, the material forming the counter electrode includes one or more of carbon, gold, silver, copper, and their composite materials. According to embodiments of the present invention, the counter electrode is modified onto the substrate using processes including but not limited to printing, inkjet printing, electrohydraulic inkjet printing (EHD), dispensing, spraying, chemical vapor deposition (CVD), physical vapor deposition (PVD), magnetron sputtering, molecular beam epitaxy, electrochemical deposition, electroplating, and evaporation deposition. According to embodiments of the present invention, the thickness of the counter electrode layer is 1gm-20gm, preferably 5gm-15gm, for example, 2gm, 3gm, 4gm, 5gm, 6gm, 7gm, 8gm, 9gm, 10gm, 11gm, 12gm, 15gm, or 18gm.

[0111] <Sensing layer>

[0112] According to an embodiment of the present invention, the first sensing layer 115 and the second sensing layer 122 may be the same or different. In order to enable the detection of different analytes, the first sensing layer 115 and the second sensing layer 122 are preferably different.

[0113] 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; the second sensing layer 122 is disposed on the second working electrode layer 119 of the second working electrode.

[0114] According to embodiments of the present invention, the material forming the sensing layer includes one or more of the following: biological enzymes, noble metals, transition metals, transition metal oxides, and transition metal hydroxides. Exemplarily, the biological enzymes include glucose oxidase, glucose dehydrogenase, uricase, lactase, 3-hydroxybutyrate dehydrogenase, etc.; the noble metals include gold and its composites, tin and its composites; the transition metals include copper and its composites, tin and its composites, cobalt and its composites, argon and its composites, zinc and its composites, iridium and its composites, iron and its composites, etc.

[0115] According to embodiments 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, electrochemical inkjet printing (EHD), dispensing, spraying, chemical vapor deposition (CVD), physical vapor deposition (PVD), magnetron sputtering, molecular beam epitaxy, electrochemical deposition, evaporation and vapor deposition.

[0116] According to embodiments 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, electrochemical inkjet printing (EHD), dispensing, spraying, chemical vapor deposition (CVD), physical vapor deposition (PVD), magnetron sputtering, molecular beam epitaxy, electrochemical deposition, evaporation and vapor deposition.

[0117] 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 may be the same or different.

[0118] According to an embodiment of the present invention, the thickness of the first sensing layer 115 is 1gm-20gm, preferably 1gm-10gm, for example 2gm, 3gm, 4gm, 5gm, 6gm, 7gm, 8gm, 9gm, 10gm, 11gm, 12gm, 15gm or 18gm.

[0119] According to an embodiment of the present invention, the thickness of the second sensing layer 122 is 1 gm-20 gm, preferably 1 gm-10 gm, for example 2 gm, 3 gm, 4 gm, 5 gm, 6 gm, 7 gm, 8 gm, 9 gm, 10 gm, 11 gm, 12 gm, 15 gm or 18 gm.

[0120] According to an embodiment of the present invention, the first sensing layer and the second sensing layer function as continuous monitoring of multiple analytes.

[0121] According to embodiments of the present invention, the analytes / physiological indicators that the first sensing layer and the second sensing layer can monitor include blood glucose, uric acid, lactic acid, blood ketones, cholesterol, triglycerides, heart rate, blood pressure, Na+, Ka+, and Ga. 2 One or more of Fe²⁺ and Mg²⁺. For example, the first sensing layer can monitor analytes / physiological indicators such as blood glucose; the second sensing layer can monitor analytes / physiological indicators including uric acid, lactic acid, blood ketones, cholesterol, triglycerides, heart rate, blood pressure, Na⁺, Ka⁺, and Ga⁺. 2 One of Fe²⁺ and Mg²⁺, etc. <Electrode Setup>

[0122] In this invention, two electrodes spatially separated by a channel refer to two electrodes in which the electrode layer of one electrode and the electrode wire of the other electrode are spatially separated by a channel.

[0123] According to an embodiment of the present invention, the two electrodes spatially separated 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, and the reference electrode layer 113 of the reference electrode is located at the middle end 102 of the substrate. The reference electrode and the first working electrode are spatially separated by a channel. Alternatively, 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 and the first working electrode are spatially separated by a channel. According to an embodiment of the present invention, the two electrodes spatially separated 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, and the reference electrode layer 113 of the reference electrode is located at the middle end 102 of the substrate. The reference electrode and the second working electrode are spatially separated by a channel. Alternatively, 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 and the second working electrode are spatially separated by a channel.

[0124] According to an embodiment of the present invention, the two electrodes spatially separated 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, and the counter electrode layer 104 of the counter electrode is located at the middle end 102 of the substrate. The counter electrode and the first working electrode are spatially separated by a channel. Alternatively, 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 and the first working electrode are spatially separated by a channel.

[0125] According to an embodiment of the present invention, the two electrodes spatially separated 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, and the counter electrode layer 104 of the counter electrode is located at the middle end 102 of the substrate. The counter electrode and the second working electrode are spatially separated by a channel. Alternatively, 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 and the second working electrode are spatially separated by a channel.

[0126] According to an embodiment of the present invention, the two electrodes spatially separated 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, and the counter electrode layer 104 of the counter electrode is located at the middle end 102 of the substrate. The reference electrode and the counter electrode are spatially separated by a channel. Alternatively, 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 reference electrode and the counter electrode are spatially separated by a channel.

[0127] According to an embodiment of the present invention, the two electrodes spatially separated 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, and the second working electrode layer 120 of the second working electrode is located at the middle end 102 of the substrate. The first working electrode and the second working electrode are spatially separated by a channel. Alternatively, 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 120 of the second working electrode is located at the front end 101 of the substrate. The first working electrode and the second working electrode are spatially separated by a channel.

[0128] 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.

[0129] 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.

[0130] 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.

[0131] 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.

[0132] 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.

[0133] 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.

[0134] 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.

[0135] 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.

[0136] 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. 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. 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.

[0137] 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.

[0138] According to an embodiment of the present invention, when the two electrodes spatially separated by a channel are a first working electrode and a reference electrode, the first working electrode and the reference electrode are located on the same plane. Specifically, the first working electrode layer 107, the first working electrode wire 108, the first working electrode contact 109, the reference electrode layer 113, the reference electrode wire 110, and the reference electrode contact 112 of the reference electrode are all located on the same plane. Alternatively, when the two electrodes spatially separated by a channel are a first working electrode and a 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 layer, the electrode wire, and the electrode contact of the first working electrode and the reference electrode is located on the same plane, and at least one component of the electrode layer, the electrode wire, and the electrode contact of the first working electrode and the reference electrode is not located on the same plane.

[0139] According to an embodiment of the present invention, when the two electrodes spatially separated by a channel are a second working electrode and a reference electrode, the second working electrode and the reference electrode are located on the same plane. Specifically, the second working electrode layer 119, the second working electrode wire 120, the second working electrode contact 121, the reference electrode layer 113, the reference electrode wire 110, and the reference electrode contact 112 of the reference electrode are all located on the same plane. Alternatively, when the two electrodes spatially separated by a channel are a second working electrode and a 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 layer, the electrode wire, and the electrode contact of the second working electrode and the reference electrode is located on the same plane, and at least one component of the electrode layer, the electrode wire, and the electrode contact of the second working electrode and the reference electrode is not located on the same plane.

[0140] According to an embodiment of the present invention, when the two electrodes spatially separated by a channel are a first working electrode and a counter electrode, the first working electrode and the counter electrode are located on the same plane. Specifically, the first working electrode layer 107, the first working electrode wire 108, the first working electrode contact 109, the counter electrode layer 104, the counter electrode wire 105, and the counter electrode contact 106 of the counter electrode are all located on the same plane. Alternatively, when the two electrodes spatially separated by a channel are a first working electrode and a 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 layer, the electrode wire, and the electrode contact of the first working electrode and the counter electrode is located on the same plane, and at least one component of the electrode layer, the electrode wire, and the electrode contact of the first working electrode and the counter electrode is not located on the same plane.

[0141] According to an embodiment of the present invention, when the two electrodes spatially separated by a channel are a second working electrode and a counter electrode, the second working electrode and the counter electrode are located on the same plane. Specifically, the second working electrode layer 119, the second working electrode wire 120, the second working electrode contact 121, the counter electrode layer 104, the counter electrode wire 105, and the counter electrode contact 106 of the counter electrode are all located on the same plane. Alternatively, when the two electrodes spatially separated by a channel are a second working electrode and a 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 layer, the electrode wire, and the electrode contact of the second working electrode and the counter electrode is located on the same plane, and at least one component of the electrode layer, the electrode wire, and the electrode contact of the second working electrode and the counter electrode is not located on the same plane.

[0142] According to an embodiment of the present invention, when the two electrodes spatially separated by a channel are a counter electrode and a reference electrode, the counter electrode and the reference electrode are located on the same plane. Specifically, the counter electrode layer 104, the counter electrode wire 105, the counter electrode contact 106, the reference electrode layer 113, the reference electrode wire 110, and the reference electrode contact 112 of the reference electrode are all located on the same plane. Alternatively, when the two electrodes spatially separated by a channel are a counter electrode and a reference electrode, the counter electrode and the reference electrode are partially located on the same plane. Specifically, at least one component of the electrode layer, the electrode wire, and the electrode contact of the counter electrode and the reference electrode is located on the same plane, and at least one component of the electrode layer, the electrode wire, and the electrode contact of the counter electrode and the reference electrode is not located on the same plane.

[0143] According to an embodiment of the present invention, when the two electrodes spatially separated by a channel are a first working electrode and a 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, the first working electrode wire 108, the first working electrode contact 109, the second working electrode layer 119, the second working electrode wire 120, and the second working electrode contact 121 of the second working electrode are all located on the same plane. Alternatively, when the two electrodes spatially separated by a channel are a first working electrode and a 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 layer, the electrode wire, and the electrode contact of the first working electrode and the second working electrode is located on the same plane, and at least one component of the electrode layer, the electrode wire, and the electrode contact of the first working electrode and the second working electrode is not located on the same plane.

[0144] <Structure of the channel>

[0145] According to an embodiment of the present invention, as shown in FIG41, 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, which are spatially separated by the channel, as shown by the line segment " " in FIG41. The ' represents the width of channel 114. The specific electrode layers and electrode wires need to be determined based on the arrangement of the first working electrode, second working electrode, reference electrode, and counter electrode inside the sensor. For example, 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 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 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 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 the distance between the reference electrode wire 110 of the reference electrode and the counter electrode layer 104 of the counter electrode; or the distance between the reference electrode wire 110 of the reference electrode and the second working electrode layer 119 of the second working electrode. The distance between; 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.

[0146] According to an embodiment of the present invention, the width of the channel can be fixed or gradually varied; if fixed, the width of the channel is a fixed value in the range of 1 μm to 280 μm; if gradually varied, 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 of 1 μm to 280 μm, for example, varying within a width range of 50 μm to 150 μm or varying within a width range of 80 μm to 200 μm.

[0147] According to an embodiment of the present invention, the width of the channel is 1 gm-280 gm, preferably 50 gm-170 gm, for example, 20 gm, 30 gm, 40 gm, 50 gm, 60 gm, 70 gm, 80 gm, 90 gm, 100 gm, 110 gm, 120 gm, 130 gm, 140 gm, 150 gm, 160 gm, 170 gm, 180 gm, 190 gm, 200 gm, 210 gm, 220 gm, 230 gm, 240 gm, 250 gm, 260 gm, 270 gm, 280 gm or a range consisting of the above two endpoint values. Research has found that when the width of the channel is 1-280 μm, it can effectively separate electrodes located on the same side surface of the sensor, enabling multiple functional areas / electrode areas to function 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 1 μm, the narrow channel width may lead to contact between the two electrodes, resulting in short circuits between the electrodes, which in turn causes the test data to be too high or too low, causing the sensor to fail. When the width of the channel is greater than 280 μm, the excessively wide channel width may result in the electrodes / electrode wires being too narrow, which may lead to insufficient area of ​​the functional area / electrode area, or electrode breakage due to the narrow electrodes / electrode wires, causing data "jumping" or "jittering" during the sensor test, affecting the stability of the test data, and thus causing the sensor to fail. According to an embodiment of the present invention, as shown in FIG41, the length of the channel 114 refers to the length from the front end of the electrode layer located in the middle of the substrate to the first [missing information - likely a specific length] of the substrate.

[0148]

[0149] The distance between the connection point of the first and second sides, represented by the line segment in Figure 41, is the length of the channel 114. The specific electrode layer needs to be determined based on the arrangement of the first working electrode, second working electrode, reference electrode, and counter electrode inside the sensor. For example, the length of the channel is the distance from the front end of the first working electrode layer of the first working electrode located in the middle of the substrate to the connection point of 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 in the middle of the substrate to the connection point of 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 in the middle of the substrate to the connection point of 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 in the middle of the substrate to the connection point of the first and second sides of the substrate. The front end of the electrode layer refers to the end closest to the front end of the substrate.

[0150] According to an embodiment of the present invention, the length of the channel is 30gm-10000gm, for example, 30gm, 40gm, 50gm, 60gm, 70gm, 80gm, 90gm, 100gm, 110gm, 120gm, 130gm, 140gm, 150gm, 160gm, 170gm, 180gm, 190gm, 200gm, 210gm, 220gm, 230gm, 240gm, 250gm, 260gm, 270gm, 280gm, 300gm, 320gm, 350gm, 380gm, 400gm, 450gm, 500gm, 550gm. 600gm > 700gm > 800gm > 900gm > 1000gm, 1100gm, 1200gm > 1300gm > 1400gm > 1500gm, 2000gm > 2500gm, 3000gm > 3500gm, 4000gm > 4500gm, 5000gm > 5500gm, 6000gm > 6500gm, 7000gm > 7500gm, 8000gm > 8500gm, 9000gm > 9500gm or 10000gm. Studies have found that when the length of the groove is between 30gm and 10000gm, it can effectively monitor the monitored object and provide good wearing comfort; when the length of the groove is less than 30gm, the analyte sensor may not be able to effectively contact the body fluid, thus posing a risk of failure to monitor; when the length of the groove is greater than 10000gm, due to excessive implantation, the wearer is prone to bleeding and pain, affecting the wearing experience.

[0151] According to embodiments of the present invention, the channel can be obtained by methods such as printing, engraving, etching, inkjet printing, electrohydraulic inkjet printing (EHD), dispensing, spraying, chemical vapor deposition (CVD), physical vapor deposition (PVD), magnetron sputtering, molecular beam epitaxy, electrochemical deposition, and evaporation.

[0152] <Structure of the Sensor>

[0153] According to an embodiment of the present invention, the analyte sensor is a four-electrode system, and the combination of the four electrodes can stabilize the potential. 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.

[0154] According to an embodiment of the present invention, the analyte sensor has an L-shape. The L-shaped sensor, on the one hand, can be adapted to auxiliary devices to better complete the analysis; on the other hand, the L-shape effectively prevents damage to the sensor during implantation, increasing the probability of successful implantation. 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 the connection between the first side and the second side forms an included angle, the included angle being 45°-135°, preferably 88°-98°.

[0155] 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 disposed on the first side of the L-shaped sensor, and the contact area is disposed on the second side of the sensor.

[0156] 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.

[0157] 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 disposed on the first side of the L-shaped sensor, and the contact area is disposed on the second side of the sensor.

[0158] <Protruding structure>

[0159] According to an embodiment of the present invention, a protrusion structure 118 is formed at the connection between the first side and the second side. Preferably, a protrusion structure is formed on the outer edge of the connection between the first side and the second side. The protrusion structure enables the sensor to adapt to the auxiliary device during implantation and makes the sensor implantation process smoother.

[0160] According to an embodiment of the present invention, the shape of the protrusion structure can be semi-circular, triangular, square, or polygonal, as shown in FIG34. According to an embodiment of the present invention, the number of the protrusion structures can be one or more, as shown in FIG34.

[0161] According to an embodiment of the present invention, the dielectric layer is disposed on the surface of the first working electrode wire of the first working electrode to protect the working electrode from damage; the dielectric layer is disposed on the surface of the second working electrode wire of the second working electrode to protect the working electrode from damage; the dielectric layer is disposed on the surface of the reference electrode to protect the reference electrode from damage; and the dielectric layer is disposed on the surface of the counter electrode wire of the counter electrode to protect the counter electrode from damage.

[0162] According to embodiments of the present invention, the material forming the dielectric layer includes at least one of plastics (such as polyethylene terephthalate PET, polyimide PI, polyvinyl chloride PVC or polyethylene PE), polydimethylsiloxane PDMS, ceramics, glass, paper and textiles.

[0163] According to embodiments of the present invention, the dielectric layer is formed on the reference electrode, working electrode wire, or counter electrode wire by processes including but not limited to adsorption, printing, inkjet printing, electrochemical inkjet printing (EHD), dispensing, spraying, chemical vapor deposition (CVD), physical vapor deposition (PVD), magnetron sputtering, molecular beam epitaxy, electrochemical deposition, and evaporation.

[0164] According to embodiments of the present invention, the thickness of the dielectric layer is 1gm-1000gm, preferably 10gm-500gm, for example 10gm, 20gm, 50gm, 80gm, 100gm, 120gm, 150gm, 180gm, 200gm, 220gm, 250gm, 260gm, 280gm, 300gm, 320gm, 350gm, 380gm, 400gm, 420gm, 450gm, 480gm, 500gm, 600gm, 700gm, 800gm, 900gm, or 1000gm. In all sensor configurations disclosed herein, the various electrodes can be isolated from each other through channels.

[0165] <Protective Layer>

[0166] According to an embodiment of the present invention, the analyte sensor further includes a protective layer 116, which is disposed on the outermost layer of the sensor. According to an embodiment of the present invention, the protective layer can be a single layer or a multi-layer structure.

[0167] According to embodiments of the present invention, the protective layer may have the function of limiting flux. The protective layer may have the function of preventing bioaccumulation. 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. According to embodiments of the present invention, the protective layer may be in a gel-like or solid state.

[0168] According to an embodiment of the present invention, the protective layer may be a component, such as a filter.

[0169] According to an embodiment of the present invention, the material forming the protective layer may be an ethylene homopolymer or an ethylene copolymer.

[0170] According to an embodiment of the present invention, the thickness of the protective layer is 0.5 gm-2000 gm, preferably 2 gm-1000 gm, for example 5 gm, 10 gm, 50 gm, 80 gm, 100 gm, 150 gm, 200 gm > 250 gm, 300 gm > 350 gm, 400 gm > 450 gm, 500 gm, 600 gm > 700 gm > 800 gm > 900 gm or 1000 gm.

[0171] According to embodiments of the present invention, a protective layer is applied to the sensor using processes including but not limited to dispensing, spin coating, spraying, dip coating, scraping, nesting, wrapping, printing, inkjet printing, electrohydraulic inkjet printing (EHD), electrospinning, chemical vapor deposition (CVD), physical vapor deposition (PVD), magnetron sputtering, molecular beam epitaxy, electrochemical deposition, and evaporation deposition.

[0172] <Instructions for Analytical Sensors>

[0173] According to an embodiment of the present invention, the analyte sensor can be any one of the first, second, third or fourth generation blood glucose monitoring technologies. Specifically, different detection technologies can be used to monitor blood glucose based on the different working electrode materials and sensing layer materials. 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 via a minimally invasive procedure using an auxiliary device. Specifically, the front end and part of the middle section (i.e., the area below the protruding structure, one side of the L-shape) of the analyte sensor are implanted into the body. A current loop is formed by the first working electrode and the counter electrode; a voltage loop is formed by the first working electrode and the reference electrode; a current loop is formed by the second working electrode and the counter electrode; and a voltage loop is formed by the second working electrode and the reference electrode. This allows the first sensing layer on the first working electrode to generate an electrochemical signal after reacting with the first analyte, thereby monitoring the first analyte. Similarly, the second sensing layer on the second working electrode generates an electrochemical signal after reacting with the second analyte, thereby monitoring the second analyte. Furthermore, the strength of the generated electrochemical signal corresponds to the concentration of the analyte; that is, the higher the concentration of the analyte, the stronger the electrochemical signal.

[0174] According to embodiments of the present invention, the analyte sensor can detect a first analyte and a second analyte using one analytical method, or it can detect the first analyte and the second analyte separately using two analytical methods. Exemplarily, the analytical method is an electrochemical + electrochemical, electrochemical + mechanical, electrochemical + electrical, electrochemical + thermal, electrochemical + optical, electrochemical + acoustic, electrochemical + electromagnetic, etc. According to embodiments of the present invention, the analyte sensor may contain an enzyme or not contain an enzyme, or a combination of enzyme and enzyme-free methods. For example, the analyte sensor can detect / monitor blood glucose + uric acid, lactic acid, blood ketones, cholesterol, triglycerides, heart rate, blood pressure, Na+, Ka+, Ga+, etc., using enzyme-containing or enzyme-free sensor technology. 2 Fe 2 Mg2+, etc.

[0175] 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 via a minimally invasive procedure using an auxiliary device. Specifically, the front end and part of the middle portion (i.e., the area below the protruding structure, one side of the L-shape) of the analyte sensor are implanted. A current loop is formed using the first working electrode, the second working electrode, and the counter electrode; a voltage loop is formed using the first working electrode, the second working electrode, and the reference electrode. This allows the first sensing layer on the first working electrode to generate an electrochemical signal after reacting with the first analyte, thereby monitoring the first analyte. Simultaneously, the second sensing layer on the second working electrode generates an electrochemical signal after reacting with the second analyte, thereby monitoring the second analyte. Furthermore, the strength of the generated electrochemical signal corresponds to the analyte concentration; that is, the higher the analyte concentration, the stronger the electrochemical signal. <Detection Method for Determining Analytes>

[0176] A detection method for determining an analyte, the detection method comprising:

[0177] 1) The analyte sensor is exposed to a fluid containing a first analyte and a second analyte at different concentrations. A voltage is applied to the first working electrode of the sensor to obtain a first electrochemical signal with different signal intensities, the signal intensity of which is proportional to the concentration of the first analyte in the fluid; a voltage is applied to the second working electrode of the sensor to obtain a second electrochemical signal with different signal intensities, the signal intensity of which is proportional to the concentration of the second analyte in the fluid.

[0178] 2) Correlate the signal intensity of the first electrochemical signal with the concentration of the first analyte in the fluid to obtain a standard curve of the signal intensity of the first electrochemical signal and the concentration of the first analyte; correlate the signal intensity of the second electrochemical signal with the concentration of the second analyte in the fluid to obtain a standard curve of the signal intensity of the second electrochemical signal and the concentration of the second analyte;

[0179] 3) Expose the analyte sensor to a fluid containing the first and second analytes being monitored, apply a voltage to the first working electrode in the sensor to obtain a first electrochemical signal, and obtain the concentration of the first analyte being monitored in the fluid based on the signal intensity of the first electrochemical signal; apply a voltage to the second working electrode in the sensor to obtain a second electrochemical signal, and obtain the concentration of the second analyte being monitored in the fluid based on the signal intensity of the second electrochemical signal.

[0180] The present invention will be further described in detail below with reference to specific embodiments. It should be understood that the following embodiments are merely illustrative and explanatory 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 covered within the scope of protection intended by the present invention.

[0181] Unless otherwise specified, the experimental methods used in the following examples are conventional methods; unless otherwise specified, the reagents and materials used in the following examples are commercially available.

[0182] Example 1 The structure of sensor electrode structure A in Example 1 is shown in Figures 1-4. Figure 1 is a view of sensor electrode structure A in Example 1, where the left figure is a rear view of sensor electrode structure A, the middle figure is a second front view of sensor electrode structure A, and the right figure is a first front view of sensor electrode structure A. As shown in Figure 1, 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 includes a front end 101, a middle end 102, and a rear end 103. 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 disposed on the surface of the substrate 100, the reference electrode is stacked on the surface of the first working electrode and separated by a dielectric layer 117, and the second working electrode is stacked on the surface of the first working electrode and 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.

[0183] 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. The reference electrode layer 113 is disposed 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.

[0184] The sensor electrode structure A includes a channel 114 located between the second working electrode wire 120 and the reference electrode layer 113, separating the second working electrode and the reference electrode. The width of the channel 114 is adjustable from 1gm to 280gm, and the length of the channel is adjustable from 30gm to 10000gm. The sensor electrode structure A has an L-shape, including a first side and a second side, with the connection between the first side and the second side forming an angle of 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, which is disposed on the outside of the sensor.

[0185] Figure 2 is a schematic diagram of the sensor electrode structure A along cross-section A-A' of Embodiment 1. Figure 3 is a schematic diagram of the sensor electrode structure A along cross-section B-B' of Embodiment 1. Figure 4 is a schematic diagram of the sensor electrode structure A along cross-section C-C' of Embodiment 1. As can be seen from Figures 2-4, the first working electrode is disposed on the surface of the substrate 100, the reference electrode is stacked on the surface of the first working electrode and separated by the dielectric layer 117, and the second working electrode is stacked 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.

[0186] Example 2

[0187] The structure of sensor electrode structure B in Embodiment 2 is shown in Figures 5-8. Figure 5 is a view of sensor electrode structure B in Embodiment 2, where the left figure is a second-layer rear view of sensor electrode structure B, the middle figure is a first-layer rear view of sensor electrode structure B, and the right figure is a front view of sensor electrode structure B. As shown in Figure 5, 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 includes a front end 101, a middle end 102, and a rear end 103. 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 disposed on the surface of the substrate 100, the reference electrode is stacked on the surface of the second working electrode and separated by a dielectric layer 117, the counter electrode is stacked on the surface of the second working electrode and 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. 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, wherein the reference electrode layer 113 is disposed on the reference electrode wire 110; the counter electrode includes a counter electrode layer 104 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.

[0188] The sensor electrode structure B includes a channel 114 located between the counter electrode wire 105 and the reference electrode layer 113, separating the counter electrode and the reference electrode. The width of the channel 114 is adjustable from 1gm to 280gm, and the length of the channel is adjustable from 30gm to 10000gm. The sensor electrode structure B has an L-shape, including a first side and a second side, with the connection between the first side and the second side forming an angle of 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, which is disposed on the outside of the sensor.

[0189] Figure 6 is a schematic diagram of the sensor electrode structure B of Embodiment 2 along cross section A-A'. Figure 7 is a schematic diagram of the sensor electrode structure B of Embodiment 2 along cross section B-B'. Figure 8 is a schematic diagram of the sensor electrode structure B of Embodiment 2 along cross section C-C'. As can be seen from Figures 6-8, the second working electrode is disposed on the surface of the substrate 100, the reference electrode is stacked on the surface of the second working electrode and separated by the dielectric layer 117, the counter electrode is stacked 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.

[0190] Example 3

[0191] The structure of the sensor electrode structure C in Embodiment 3 is shown in Figures 9-12. Figure 9 is a view of the sensor electrode structure C in Embodiment 3, where the left figure is a rear view of the sensor electrode structure C, the middle figure is a second front view of the sensor electrode structure C, and the right figure is a first front view of the sensor electrode structure C. As shown in Figure 9, 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 includes a front end 101, a middle end 102, and a rear end 103. 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), while 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 disposed on the first surface of the substrate 100, and the second working electrode is stacked on the surface of the first working electrode and 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 disposed 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.

[0192] 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. The reference electrode layer 113 is disposed 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.

[0193] The sensor electrode structure C includes a channel 114 located between the counter electrode wire 105 and the reference electrode layer 113, separating the counter electrode and the reference electrode. The width of the channel 114 is adjustable from 1gm to 280gm, and the length of the channel is adjustable from 30gm to 10000gm. The sensor electrode structure C has an L-shape, including a first side and a second side, with the connection between the first side and the second side forming an included angle of 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, which is disposed on the outside of the sensor.

[0194] Figure 10 is a schematic diagram of the sensor electrode structure C of Embodiment 3 along cross section A-A'. Figure 11 is a schematic diagram of the sensor electrode structure C of Embodiment 3 along cross section BB'. Figure 12 is a schematic diagram of the sensor electrode structure C of Embodiment 3 along cross section C-C'. As can be seen from Figures 10-12, the first working electrode is disposed on the first surface of the substrate 100, and the second working electrode is stacked 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 disposed 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.

[0195] Example 4

[0196] The structure of the sensor electrode structure D in Embodiment 4 is shown in Figures 13-16. Figure 13 is a view of the sensor electrode structure D in Embodiment 4, where the left figure is a second-layer rear view of the sensor electrode structure D, the middle figure is a first-layer rear view of the sensor electrode structure D, and the right figure is a front view of the sensor electrode structure D. As shown in Figure 13, 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 includes a front end 101, a middle end 102, and a rear end 103. 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), while 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 disposed on the first surface of the substrate 100 and are spatially separated by a channel, with all components of the first working electrode and the second working electrode located on the same plane. The counter electrode is disposed on the second surface of the substrate 100 opposite to the first surface, and the reference electrode is stacked 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.

[0197] 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, wherein the reference electrode layer 113 is disposed 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.

[0198] The sensor electrode structure D includes a channel 114 located between the first working electrode wire 108 and the second working electrode layer 119, separating the first and second working electrodes. The width of the channel 114 is adjustable from 1gm to 280gm, and the length of the channel is adjustable from 30gm to 10000gm. The sensor electrode structure D has an L-shape, including a first side and a second side, with the connection between the first side and the second side forming an angle of 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, which is disposed on the outside of the sensor.

[0199] Figure 14 is a schematic diagram of the sensor electrode structure D of Embodiment 4 along cross section A-A'. Figure 15 is a schematic diagram of the sensor electrode structure D of Embodiment 4 along cross section B-B'. Figure 16 is a schematic diagram of the sensor electrode structure D of Embodiment 4 along cross section C-C'. As can be seen from Figures 14-16, the first working electrode and the second working electrode are disposed on the first surface of the substrate 100, and the first working electrode and the second working electrode are spatially separated 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 disposed on the second surface of the substrate 100 opposite to the first surface, and the reference electrode is stacked on the surface of the counter electrode and separated by the dielectric layer 117; the counter electrode is closer to the front end 101 of the substrate than the reference electrode.

[0200] Example 5

[0201] The structure of the sensor electrode structure E in Embodiment 5 is shown in Figures 17-20. Figure 17 is a view of the sensor electrode structure E in Embodiment 5, wherein the first figure on the left is a second-layer view of the back of the sensor electrode structure E, the second figure on the left is a first-layer view of the back of the sensor electrode structure E, the first figure on the right is a first-layer view of the front of the sensor electrode structure E, and the second figure on the right is a second-layer view of the front of the sensor electrode structure E. As shown in Figure 17, 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 includes a front end 101, a middle end 102, and a rear end 103. 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), while 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 disposed on the first surface of the substrate 100, and the second working electrode is stacked on the surface of the first working electrode and 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 disposed 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 some components of the counter electrode and the reference electrode are located on the same plane, while some components are located on different planes.

[0202] 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 middle end 102 of the substrate and a second working electrode wire 120 located on 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 located at the middle end 102 of the substrate and a reference electrode wire 110, and a reference electrode contact 112 located at the end 103 of the substrate, wherein the reference electrode layer 113 is disposed on the reference electrode wire 110; the counter electrode includes a first working electrode layer 107 located at the front end 101 of the substrate and a second working electrode wire 110 located at the middle end 102 of the substrate and a reference electrode contact 112 located on the end 103 of the substrate, and the reference electrode layer 113 is disposed on the reference electrode wire 110; the counter electrode includes a first working electrode layer 107 located at the front end 101 of the substrate and a second working electrode wire 110 located at the middle end 102 of the substrate and a third working electrode contact 112 located on the end 103 of the substrate, wherein the reference electrode layer 113 is disposed on the reference electrode wire 110; the counter electrode includes a first working electrode layer 107 located at the front end 101 of the substrate and a second working electrode wire 110 located at the middle end 102 of the substrate and a third working electrode contact 110 located on the end 103 of the substrate. The electrode layer 104, the electrode wire 105 located at the middle end 102 of the substrate, and the electrode contact 106 located at the end 103 of the substrate.

[0203] The sensor electrode structure E includes a channel 114 located between the counter electrode wire 105 and the reference electrode layer 113, separating the counter electrode and the reference electrode. The width of the channel 114 is adjustable from 1gm to 280gm, and the length of the channel is adjustable from 30gm to 10000gm. The sensor electrode structure E has an L-shape, including a first side and a second side, with the connection between the first side and the second side forming an included angle of 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 disposed on the outside of the sensor.

[0204] Figure 18 is a schematic diagram of the sensor electrode structure E of Embodiment 5 along cross section A-A'. Figure 19 is a schematic diagram of the sensor electrode structure E of Embodiment 5 along cross section BB'. Figure 20 is a schematic diagram of the sensor electrode structure E of Embodiment 5 along cross section C-C'. As can be seen from Figures 18-20, the first working electrode is disposed on the first surface of the substrate 100, and the second working electrode is stacked 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 disposed on the second surface of the substrate 100 opposite to the first surface, and the counter electrode and the reference electrode are spatially separated by a channel, with some components of the counter electrode and the reference electrode located on the same plane and some components located on different planes.

[0205] The structure of the sensor electrode structure F in Example 6 is shown in Figures 21-24. Figure 21 is a view of the sensor electrode structure F in Example 6, where the left figure is a rear view of the sensor electrode structure F and the right figure is a front view of the sensor electrode structure F. As shown in Figure 21, 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 includes a front end 101, a middle end 102, and a rear end 103. 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), while 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 disposed on the first surface of the substrate 100, and are spatially separated by a channel, with all components of the first working electrode and the second working electrode located on the same plane. The counter electrode and the reference electrode are disposed on the second surface of the substrate 100 opposite to the first surface, and are spatially separated by a channel, with all components of the counter electrode and the reference electrode located on the same plane.

[0206] 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, wherein the reference electrode layer 113 is disposed 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.

[0207] The sensor electrode structure F includes a channel 114 located between the counter electrode wire 105 and the reference electrode layer 113, separating the counter electrode and the reference electrode. The width of the channel 114 is adjustable from 1gm to 280gm, and the length of the channel is adjustable from 30gm to 10000gm. 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, separating the first working electrode and the second working electrode. The width of the channel 114 is adjustable from 1gm to 280gm, and the length of the channel is adjustable from 30gm to 10000gm. The sensor electrode structure F has an L-shape, including a first side and a second side, with the connection between the first side and the second side forming an included angle of 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 protective layer 116, which is disposed on the outside of the sensor.

[0208] Figure 22 is a schematic diagram of the sensor electrode structure F of Embodiment 6 along cross section A-A'. Figure 23 is a schematic diagram of the sensor electrode structure F of Embodiment 6 along cross section BB'. Figure 24 is a schematic diagram of the sensor electrode structure F of Embodiment 6 along cross section C-C'. As can be seen from Figures 22-24, the first working electrode and the second working electrode are disposed on the first surface of the substrate 100, and the first working electrode and the second working electrode are spatially separated 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 disposed on the second surface of the substrate 100 opposite to the first surface, and 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.

[0209] Example 7

[0210] The structure of the sensor electrode structure G in Embodiment 7 is shown in Figures 25-28. Figure 25 is a view of the sensor electrode structure G in Embodiment 7, where the left figure is a rear view of the sensor electrode structure G and the right figure is a front view of the sensor electrode structure G. As shown in Figure 25, 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 includes a front end 101, a middle end 102, and a rear end 103. 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), while 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 disposed on the first surface of the substrate 100, and are spatially separated by a channel, with all components of the first working electrode and the reference electrode located on the same plane. The counter electrode and the second working electrode are disposed on the second surface of the substrate 100 opposite to the first surface, and are spatially separated by a channel, with all components of the counter electrode and the second working electrode located on the same plane.

[0211] 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. The reference electrode layer 113 is disposed 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.

[0212] The sensor electrode structure G includes a channel 114 located between the first working electrode wire 108 and the reference electrode layer 113, separating the first working electrode and the reference electrode. The width of the channel 114 is adjustable from 1 μm to 280 μm, and the length of the channel is adjustable from 30 μm to 10000 μm. The sensor electrode structure G also includes a channel 114 located between the second working electrode wire 120 and the counter electrode layer 104, separating the second working electrode and the counter electrode. The width of the channel 114 is adjustable from 1 μm to 280 μm, and the length of the channel is adjustable from 30 μm to 10000 μm. The sensor electrode structure G has an L-shape, including a first side and a second side, with the connection between the first side and the second side forming an angle of 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.

[0213] Figure 26 is a schematic diagram of the sensor electrode structure G of Embodiment 7 along cross section A-A'. Figure 27 is a schematic diagram of the sensor electrode structure G of Embodiment 7 along cross section BB'. Figure 28 is a schematic diagram of the sensor electrode structure G of Embodiment 7 along cross section C-C'. As can be seen from Figures 26-28, the first working electrode and the reference electrode are disposed on the first surface of the substrate 100, and are spatially separated by a channel, with all components of the first working electrode and the reference electrode located on the same plane; the counter electrode and the second working electrode are disposed on the second surface of the substrate 100 opposite to the first surface, and are spatially separated by a channel, with all components of the counter electrode and the second working electrode located on the same plane.

[0214] Example 8

[0215] The structure of the sensor electrode structure H in Embodiment 8 is shown in Figures 29-32. Figure 29 is a view of the sensor electrode structure H in Embodiment 8, where the first figure on the left is a second-layer view of the back of the sensor electrode structure H, the second figure on the left is a first-layer view of the back of the sensor electrode structure H, the first figure on the right is a first-layer view of the front of the sensor electrode structure H, and the second figure on the right is a second-layer view of the front of the sensor electrode structure H. As shown in Figure 29, 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 includes a front end 101, a middle end 102, and a rear end 103. 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), while 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, and are spatially separated by a channel. Some components of the reference electrode and the second working electrode are located on the same plane, while 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, and are spatially separated by a channel. Some components of the counter electrode and the first working electrode are located on the same plane, while some components are located on different planes. 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, wherein the reference electrode layer 113 is disposed on the reference electrode wire 110; the counter electrode includes a counter electrode layer 104 located at the middle end 102 of the substrate. And the counter electrode wire 105, and the counter electrode contact 106 located at the end 103 of the substrate.

[0216] The sensor electrode structure H includes a channel 114 located between the first working electrode wire 108 and the counter electrode layer 104, separating the first working electrode and the counter electrode. The width of the channel 114 is adjustable from 1 μm to 280 μm, and the length of the channel is adjustable from 30 μm to 10000 μm. The sensor electrode structure H also includes a channel 114 located between the second working electrode wire 120 and the reference electrode layer 113, separating the second working electrode and the reference electrode. The width of the channel 114 is adjustable from 1 μm to 280 μm, and the length of the channel is adjustable from 30 μm to 10000 μm. The sensor electrode structure H has an L-shape, including a first side and a second side, with the connection between the first side and the second side forming an angle of 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 protective layer 116, which is disposed on the outside of the sensor.

[0217] Figure 30 is a schematic diagram of the sensor electrode structure H of Embodiment 8 along cross section A-A'. Figure 31 is a schematic diagram of the sensor electrode structure H of Embodiment 8 along cross section BB'. Figure 32 is a schematic diagram of the sensor electrode structure H of Embodiment 8 along cross section C-C'. As can be seen from Figures 29-32, the reference electrode and the second working electrode are located on the first surface of the substrate 100, and the reference electrode and the second working electrode are spatially separated by a channel. 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 spatially separated 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.

[0218] Example 9

[0219] The structure of sensor electrode structure I in Embodiment 9 is shown in Figures 33-36. Figure 33 is a view of sensor electrode structure I in Embodiment 8, wherein the first figure on the left is a second layer view of the back of sensor electrode structure I, the second figure on the left is a first layer view of the back of sensor electrode structure I, the first figure on the right is a first layer view of the front of sensor electrode structure I, and the second figure on the right is a second layer view of the front of sensor electrode structure I. As shown in Figure 33, 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 includes a front end 101, a middle end 102, and a rear end 103. 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), while 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, and are spatially separated by a channel. Some components of the first working electrode and the second working electrode are located on the same plane, while 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 spatially separated by a channel, and some components of the reference electrode and the counter electrode are located on the same plane, while some components are located on different planes.

[0220] The first working electrode includes 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 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. The reference electrode layer 113 is disposed 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.

[0221] The sensor electrode structure I includes a channel 114 located between the second working electrode wire 120 and the first working electrode layer 107, separating the first and second working electrodes. The width of the channel 114 is adjustable from 1 μm to 280 μm, and the length is adjustable from 30 μm to 10000 μm. The sensor electrode structure I also includes a channel 114 located between the counter electrode wire 105 and the reference electrode layer 113, separating the counter electrode and the reference electrode. The width of the channel 114 is adjustable from 1 μm to 280 μm, and the length is adjustable from 30 μm to 10000 μm. The sensor electrode structure I has an L-shape, including a first side and a second side, with the connection between the first and second sides forming an angle of 85°-95°. A protrusion structure 118 is formed at the outer edge of the connection between the first and second sides. The sensor electrode structure I includes a protective layer 116, which is disposed on the outside of the sensor.

[0222] Figure 34 is a schematic diagram of the sensor electrode structure I of Embodiment 9 along cross section A-A'. Figure 35 is a schematic diagram of the sensor electrode structure I of Embodiment 9 along cross section B-B'. Figure 36 is a schematic diagram of the sensor electrode structure I of Embodiment 9 along cross section C-C'. As can be seen from Figures 34-36, the first working electrode and the second working electrode are located on the first surface of the substrate 100, and are spatially separated by a channel. Some components of the first working electrode and the second working electrode are located on the same plane, while 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 spatially separated by a channel, and some components of the reference electrode and the counter electrode are located on the same plane, while some components are located on different planes.

[0223] Figure 38 shows a schematic diagram of the sensor and auxiliary device combined with the protruding structure (left) and a schematic diagram of the sensor and auxiliary device combined without the protruding structure (right), where reference numeral 1000 represents the auxiliary device and 1001 represents the sensor. As can be seen from Figure 38, the sensor portion without the protruding structure is located on the outside of the auxiliary device.

[0224] Figure 39 shows a schematic diagram of the sensor surface after implantation in the human body with a sensor featuring a protrusion structure (left) and a schematic diagram of the sensor surface after implantation in the human body without a protrusion structure (right). As can be seen from Figure 39, the sensor surface of the sensor without a protrusion structure was damaged after implantation in the human body, while the sensor surface of the sensor with a protrusion structure was not damaged after implantation in the human body.

[0225] Figure 40 shows the structural diagrams of a sensor with a grooved structure implanted in the human body (left) and a sensor without a grooved structure (i.e., a stacked structure) implanted in the human body (right). As can be seen from Figure 40, the sensor without a grooved structure (i.e., a stacked structure) shows visible "bloodstains" on its side after implantation, indicating significant bleeding at the implantation site, which negatively impacts the user's wearing experience. In contrast, the sensor with a grooved structure, due to its more suitable thickness, shows no obvious "bloodstains" on its side, indicating that the sensor with the grooved structure is easier to insert and provides a better wearing experience.

[0226] Comparative Example 1

[0227] Other structures are as shown in Example 7, the only difference being that the width of the channel 114 in the sensor of Comparative Example 1 is less than 1 mM. This would cause the first working electrode wire and the reference electrode to come into contact, making a short circuit between them highly likely. The trend of blood glucose changes over one day after implanting this sensor into a normal human body is shown in Figure 42. As can be seen from Figure 42, the narrow channel width in the sensor causes a short circuit between the first working electrode and the reference electrode, resulting in elevated blood glucose levels. Normal blood glucose readings are generally between 3.9 mM and 6.1 mM.

[0228] Comparative Example 2

[0229] Other structures are as shown in Example 7, the only difference being that the width of the channel 114 in the sensor of Comparative Example 2 is greater than 280 mm. This results in the electrode / electrode wire being too narrow, which can easily cause an open circuit. The trend of blood glucose changes over 4 days after the sensor was implanted in a normal human body is shown in Figure 43. As can be seen from Figure 43, the excessively wide channel width in the sensor leads to an excessively narrow first working electrode wire, causing an electrode open circuit. This results in data "jumping" or "jittering" during the blood glucose test, affecting the stability of the test data.

[0230] The embodiments of the present invention have been described above. However, the present invention is not limited to the above embodiments. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. Claim 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; the two electrodes located on the first surface of the substrate are separated in space by a channel, and / or the two electrodes located on the second surface of the substrate opposite to the first surface are separated in space by a channel; The width of the channel is 1 gm-280 gm, and the length of the channel is 30 gm-10000 gm.

2. The analyte sensor of claim 1, wherein, The first working electrode and the reference electrode are disposed on the first surface of the substrate, and the counter electrode and the second working electrode are disposed on the second surface of the substrate opposite to the first surface, and the first working electrode and the reference electrode are separated in space by a channel, and / or the counter electrode and the second working electrode are separated in space by a channel; Or, The first working electrode and the counter electrode are disposed on the first surface of the substrate, and the reference electrode and the second working electrode are disposed on the second surface of the substrate opposite to the first surface, and the first working electrode and the counter electrode are separated in space by a channel, and / or the reference electrode and the second working electrode are separated in space by a channel; Or, The counter electrode and the reference electrode are disposed on the first surface of the substrate, and the first working electrode and the second working electrode are disposed on the second surface of the substrate opposite to the first surface, and the counter electrode and the reference electrode are separated in space by a channel, and / or the first working electrode and the second working electrode are separated in space by a channel. Preferably, the two electrodes separated in space by a channel on the same side of the substrate are completely located on the same plane, or the two electrodes separated in space by a channel on the same side of the substrate are partially located on the same plane. 3.An analyte sensor, comprising a substrate, a first working electrode, a second working electrode, reference electrode, a counter electrode, a first sensing layer and a second sensing layer; the first working electrode, the second working electrode, the reference electrode and the counter electrode are located at the first surface of the substrate, and the remaining one of the first working electrode, the second working electrode, the reference electrode and the counter electrode is located at the second surface of the substrate opposite to the first surface; one of the three electrodes located at the first surface of the substrate is disposed on the surface of the substrate, and the remaining two of the three electrodes are respectively stacked on the surface of the one electrode and separated by a dielectric layer, and the remaining two of the three electrodes are separated in space by a channel; The width of the channel is 1 gm-280gm, and the length of the channel is 30 gm-10000 gm.

4. The analyte sensor of 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 of the three electrodes on the same side of the substrate and spatially separated by a channel can be completely located on the same plane; or any two of the three electrodes on the same side of the substrate and spatially separated by a channel can be partially located on the same plane.

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

6. The analyte sensor of any one of claims 1-5, wherein, The first working electrode comprises a first working electrode layer, a first working electrode lead and a first working electrode contact, and the first working electrode layer is connected with the first working electrode contact through the first working electrode lead; the first working electrode layer is located on the front end of the substrate, the first working electrode lead is located on the middle end of the substrate, and the first working electrode contact is located on the tail end of the substrate; or the first working electrode layer and the first working electrode lead are located on the middle end of the substrate, and the first working electrode contact is located on the end of the substrate. The second working electrode comprises a second working electrode layer, a second working electrode lead and a second working electrode contact, and the second working electrode layer is connected with the second working electrode contact through the second working electrode lead; the second working electrode layer is located on the front end of the substrate, the second working electrode lead is located on the middle end of the substrate, and the second working electrode contact is located on the tail end of the substrate; or the second working electrode layer and the second working electrode lead are located on the middle end of the substrate, and the second working electrode contact is located on the end of the substrate. The second working electrode comprises a second work The reference electrode comprises a reference electrode layer, a reference electrode lead and a reference electrode contact, the reference electrode layer is arranged on the reference electrode lead, and the reference electrode lead is connected with the reference electrode contact; the reference electrode layer is located at the front end of the substrate, the reference electrode lead is located at the front end and the middle end of the substrate, and the reference electrode contact is located at the tail end of the substrate; or, the reference electrode layer and the reference electrode lead are located at the middle end of the substrate, and the reference electrode contact is located at the tail end of the substrate. The counter electrode comprises a counter electrode layer, a counter electrode lead and a counter electrode contact, the counter electrode layer is connected with the counter electrode contact through the counter electrode lead; the counter electrode layer is located at the front end of the substrate, the counter electrode lead is located at the middle end of the substrate, and the counter electrode contact is located at the tail end of the substrate; or, the counter electrode layer and the counter electrode lead are located at the middle end of the substrate, and the counter electrode contact is located at the tail end of the substrate. Preferably, the counter electrode functions to form a current closed loop with the first working electrode, to provide guarantee for converting the first analyte signal into an electrochemical signal, and to form a current closed loop with the second working electrode, to provide guarantee for converting the second analyte signal into an electrochemical signal. The reference electrode functions to form a voltage loop with the first working electrode, to provide guarantee for converting the first analyte signal into an electrochemical signal, and to form a voltage loop with the second working electrode, to provide guarantee for converting the second analyte signal into an electrochemical signal.

7. The analyte sensor according to any one of claims 1-6, wherein, The second working electrode layer is provided with a second sensing layer, and the second working electrode mainly functions to react with the second analyte; the first working electrode layer is provided with a first sensing layer, and the first working electrode mainly functions to react with the first analyte; The thickness of the first working electrode layer is 1-20 gm, and the thickness of the second working electrode layer is 1-20 gm. The analyte / physiological index capable of being monitored by the first sensing layer is blood glucose; the analyte / physiological index capable of being monitored by the second sensing layer includes uric acid, lactic acid, blood ketone, cholesterol, triglyceride, heart rate, blood pressure, Na+, K+, Ga 2+ > one of Fe+and Mg2+.

8. The analyte sensor according to any one of claims 1-7, wherein, The two electrodes separated by the channel in space refer to that the electrode layer of one of the two electrodes and the electrode lead of the other electrode are separated by the channel in space. Preferably, the width of the channel can be fixed or gradually changed.

9. The analyte sensor according to any one of claims 1-8, wherein, The analyte sensor has an L shape, wherein the L shape comprises a first side and a second side, and the junction of the first side and the second side forms an included angle, and the included angle is 45°-135°. Preferably, the first surface of the analyte sensor has two contact regions and two electrode regions, the second surface opposite to the first surface of the analyte sensor has one contact region and one electrode region, the electrode region is arranged on the first side of the L-shaped sensor, and the contact region is arranged on the second side of the sensor; or, The first surface of the analyte sensor has two contact regions and two electrode regions, and the second surface opposite to the first surface of the analyte sensor has two contact regions and two electrode regions. Or, The first surface of the analyte sensor has three contact regions and three electrode regions, and the second surface of the analyte sensor, which is opposite to the first surface, has one contact region and one electrode region, the electrode region is disposed on the first side of the L-shaped sensor, and the contact region is disposed on the second side of the sensor.

10. The analyte sensor according to any one of claims 1-9, wherein, The junction of the first side and the second side forms a protruding structure. Preferably, the outer edge of the junction of the first side and the second side forms a protruding structure.

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