Analyte sensor based on blood glucose monitoring

Abstract

The present invention provides an analyte sensor based on blood glucose monitoring. The analyte sensor comprises a substrate, a working electrode, a reference electrode, a counter electrode, and a sensing layer. The sensing layer is arranged on the working electrode. The working electrode, the reference electrode, and the counter electrode are separately arranged on two sides of the substrate, and two electrodes located on the same side of the substrate are spatially separated by a channel. The analyte sensor can be implanted into a human body for monitoring. The analyte sensor features good flexibility, a small size, a low manufacturing cost, a simple manufacturing process, and long-term monitoring capacity.

Description

[0001] Analyte sensors based on blood glucose monitoring

[0002] Technical Field

[0003] This invention belongs to the field of sensor technology, specifically relating to an analyte sensor based on blood glucose monitoring.

[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 analyte sensor based on blood glucose monitoring. The analyte sensor can be implanted in the human body to monitor analytes. The analyte sensor is characterized by its flexibility, small size, 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 working electrode, a reference electrode, a counter electrode, and a sensing layer; the sensing layer is disposed on the working electrode; the working electrode, the reference electrode, and the counter electrode are respectively disposed on both sides of the substrate, and the two types of electrodes located on the same side of the substrate are spatially separated by a channel;

[0011] The width of the channel is 1 pm to 280 pm; the length of the channel is 30 pm to 10000 pm.

[0012] According to the present invention, the analyte sensor is, for example, a sensor for analyzing blood glucose, such as a blood glucose sensor.

[0013] The beneficial effects of this invention are:

[0014] This invention provides an analyte sensor for monitoring blood glucose. The analyte sensor includes a channel structure and can be implanted in the human body for monitoring. The analyte sensor is characterized by high flexibility, small size, low manufacturing cost, simple process, and long-term monitoring capability. The introduction of the channel structure in this invention makes the thickness of the analyte sensor more suitable and improves the wearing experience. At the same time, the introduction of the channel structure avoids problems such as unstable signal transmission caused by small electrode area or excessively narrow electrode wires, which lead to poor sensor stability.

[0015] Attached Figure Description

[0016] Figure 1 is a view of the sensor electrode structure A of Embodiment 1.

[0017] Figure 2 is a schematic diagram of the AA section of the sensor electrode structure A in Example 1.

[0018] Figure 3 is a schematic diagram of the cross-section BB of sensor electrode structure A in Example 1. Figure 4 is a schematic diagram of the cross-section CC of sensor electrode structure A in Example 1.

[0019] Figure 5 shows the blood glucose trend after the sensor electrode structure A of Example 1 was implanted in the human body for 14 days.

[0020] Figure 6 is a view of sensor electrode structure B in Example 2.

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

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

[0023] Figure 9 is a schematic diagram of the CC cross-section of the sensor electrode structure B in Example 2.

[0024] Figure 10 is a view of the sensor electrode structure C of Example 3.

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

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

[0027] Figure 13 is a schematic diagram of the CC cross-section of the sensor electrode structure C in Example 3.

[0028] Figure 14 is a view of the sensor electrode structure D of Example 4.

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

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

[0031] Figure 17 is a schematic diagram of the C-C' section of the sensor electrode structure D in Example 4.

[0032] Figure 18 is a view of the sensor electrode structure E of Example 5.

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

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

[0035] Figure 21 is a schematic diagram of the C-C' section of the sensor electrode structure E in Example 5.

[0036] Figure 22 is a view of the sensor electrode structure F of Embodiment 6.

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

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

[0039] Figure 25 is a schematic diagram of the CC cross-section of the sensor electrode structure F in Example 6.

[0040] Figure 26 is a view of the sensor electrode structure G of Example 7.

[0041] Figure 27 is a schematic diagram of the AA cross-section of the sensor electrode structure G in Example 7.

[0042] Figure 28 is a schematic diagram of the BB cross-section of the sensor electrode structure G in Example 7.

[0043] Figure 29 is a schematic diagram of the C-C' section of the sensor electrode structure G in Example 7.

[0044] Figure 30 is a view of the sensor electrode structure H of Example 8.

[0045] Figure 31 is a schematic diagram of the AA cross-section of the sensor electrode structure H in Example 8.

[0046] Figure 32 is a schematic diagram of the BB cross-section of the sensor electrode structure H in Example 8.

[0047] Figure 33 is a schematic diagram of the CC cross-section of the sensor electrode structure H in Example 8.

[0048] Figure 34 is a partial view of the protrusion position of the sensor of the present invention.

[0049] Figure 35 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.

[0050] Figure 36 shows the structural diagram of the sensor surface after implantation in the human body with a sensor featuring a protrusion structure (left) and the structural diagram of the sensor surface after implantation in the human body without a protrusion structure (right). Figure 37 shows the structural diagram of the sensor after implantation in the human body with a sensor featuring a channel structure (left) and the structural diagram of the sensor after implantation in the human body without a channel structure (i.e., a stacked structure) (right).

[0051] Figure 38 is a partial enlarged view of the sensor according to a preferred embodiment of the present invention.

[0052] Figure 39 shows the trend of blood glucose monitoring by the working electrode of the sensor electrode structure of Comparative Example 1 implanted in the human body for 1 day.

[0053] Figure 40 shows the trend of blood glucose monitoring by the working electrode of the sensor electrode structure of Comparative Example 2 after 2 days of implantation in the human body.

[0054] Detailed Implementation

[0055] <Analyte Sensor>

[0056] As previously described, the present invention provides an analyte sensor, the analyte sensor comprising a substrate 100, a working electrode, a reference electrode, a counter electrode, and a sensing layer 115; the sensing layer 115 is disposed on the working electrode; the working electrode, the reference electrode, and the counter electrode are respectively disposed on both sides of the substrate 100, and the two types of electrodes located on the same side of the substrate 100 are spatially separated by a channel 114.

[0057] According to an embodiment of the present invention, the working electrode, reference electrode, and counter electrode are respectively disposed on both sides of the substrate 100, that is, any two of the working electrode, reference electrode, and counter electrode are located on the same side of the substrate 100. This structural arrangement allows the first surface of the sensor to have two functional regions / electrode regions with different functions, and the two functional regions / electrode regions are spatially separated by a channel 114, so they do not affect each other. This allows the function of two functional regions / electrode regions to be realized on the same side surface of the sensor, and the second surface of the sensor opposite to the first surface has one functional region / electrode region. 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. In addition, the structural arrangement of two functional regions / electrode regions located on the same side surface of the sensor also makes the sensor fabrication process relatively simple, and at the same time ensures that the obtained sensor has good flexibility, small size, and low cost. Moreover, due to the setting of the reference electrode, the analyte sensor can monitor the analyte for a long time after implantation in the body.

[0058] Research has found that if the working electrode, reference electrode, and counter electrode are placed on the same side of the substrate, the limited implantation width of the sensor itself leads to excessively narrow areas of the electrodes and electrode wires, easily causing short circuits and open circuits. If the working electrode, reference electrode, and counter electrode are designed in a stacked structure (i.e., two electrodes are spatially positioned vertically, separated by a dielectric layer, without a spatial channel structure), this structure increases the fabrication process and difficulty, and the increased thickness affects the wearing experience and reduces sensor stability. This application, by placing the two functional areas on the same side of the substrate and separating them spatially using a channel, ensures sufficient electrode area while avoiding short circuits and open circuits. Furthermore, due to the moderate electrode thickness, the analyte sensor offers a better wearing experience and higher stability.

[0059] According to an embodiment of the present invention, the working electrode, the reference electrode, and the counter electrode are respectively disposed on both sides of the substrate 100, forming a structure in which two types of electrodes are disposed on the first surface of the substrate 100, and one type of electrode is disposed on the second surface of the substrate 100 opposite to the first surface. The two types of electrodes refer to any two of the working electrode, the reference electrode, and the counter electrode; the one type of electrode refers to any other electrode besides the two types mentioned above.

[0060] According to embodiments of the present invention, the working electrode, reference electrode, and counter electrode are respectively disposed on both sides of the substrate. For example, the working electrode and reference electrode are disposed on the first surface of the substrate, spatially separated by a channel, and the counter electrode is disposed on the second surface of the substrate opposite to the first surface; or the working electrode and counter electrode are disposed on the first surface of the substrate, spatially separated by a channel, and the reference electrode is disposed on the second surface of the substrate opposite to the first surface; or the counter electrode and reference electrode are disposed on the first surface of the substrate, spatially separated by a channel, and the working electrode is disposed on the second surface of the substrate opposite to the first surface. According to embodiments of the present invention, the two electrodes located on the same side of the substrate are located on the same plane, specifically, the electrode layers, electrode wires, and electrode contacts of the two electrodes are all located on the same plane.

[0061] According to embodiments of the present invention, two electrode portions located on the same side of the substrate are located on the same plane. Exemplarily, 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.

[0062] According to embodiments of the present invention, the working electrode, reference electrode, and counter electrode are not stacked; that is, the working electrode, reference electrode, and counter electrode are not stacked on top of each other. Even if the two electrode portions located on the same side of the substrate are on the same plane, they are not stacked on top of each other, but are spatially separated; more precisely, the two electrodes located on the same side of the substrate are on the same plane and spatially separated by a channel; or the two electrode portions located on the same side of the substrate are on the same plane and spatially separated by a channel.

[0063] <Substrate Structure and Composition>

[0064] 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.

[0065] 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°, 97° or 98°.

[0066] According to an embodiment of the present invention, the front end 101 is located on the first side and at the non-connecting end of the first side; the end end 103 is located on the second side and at the non-connecting end of the second side; and the middle end 102 is located on both the first and second sides and at the connecting end of the first side and the connecting end of the second side. The connecting end refers to the end closer to the connection between the first and second sides, and the non-connecting end refers to the end farther away from the connection between the first and second sides.

[0067] 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.

[0068] According to an embodiment of the present invention, the L-shaped

[0069]

[0070] The length of the second side of the substrate is 0.05mm-20mm, and the thickness of the substrate is 20pm-5000pm; 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 50pm-2000pm; 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.

[0071] <Structure and Composition of Working Electrode>

[0072] According to an embodiment of the present invention, the working electrode includes a working electrode layer 107, a working electrode wire 108, and a working electrode contact 109. The working electrode layer 107 is connected to the working electrode contact 109 via the working electrode wire 108. Exemplarily, the working electrode layer 107 is located at the front end 101 of the substrate, the working electrode wire 108 is located at the middle end 102 of the substrate, and the working electrode contact 109 is located at the end end 103 of the substrate; or, the working electrode layer 107 and the working electrode wire 108 are located at the middle end 102 of the substrate, and the working electrode contact 109 is located at the end end 103 of the substrate.

[0073] According to an embodiment of the present invention, a sensing layer 115 is provided on the working electrode layer, and the working electrode mainly functions to react with blood glucose.

[0074] According to embodiments of the present invention, the material forming the working electrode includes one or more of carbon, gold, silver, copper, and their composites; 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 composites, uranium and its composites; the transition metals include copper and its composites, slug and its composites, cobalt and its composites, zinc and its composites, iridium and its composites, etc. 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, 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.

[0075] According to an embodiment of the present invention, the thickness of the working electrode layer is 1 μm to 20 μm, preferably 5 μm to 15 μm, for example, 2 μm, 3 μm, 4 μm, 5 μm, 6 μm, 7 μm, 8 μm, 9 μm, 10 μm, 11 μm, 12 μm, 15 μm or 18 μm.

[0076] <Structure and Composition of Reference Electrode>

[0077] 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.

[0078] 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.

[0079] According to an embodiment of the present invention, the reference electrode forms a voltage loop with the working electrode, ensuring the conversion of blood glucose signals into electrochemical signals. 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, or 7:3.

[0080] 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.

[0081] According to an embodiment of the present invention, the thickness of the reference electrode layer is 0.1 μm to 500 μm, preferably 1 μm to 200 μm, such as 5 μm, 10 μm, 15 μm, 20 μm, 50 μm, 80 μm, 90 μm, 100 μm, 120 μm, 150 μm, 180 μm or 200 μm.

[0082] <Structure and Composition of Counter Electrode>

[0083] 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.

[0084] Exemplarily, the counter electrode layer 104 is located at the front end 101 of the substrate, the counter electrode wire 105 is located at the middle end 102 of the substrate, and the counter electrode contact 106 is located at the end 103 of the substrate; or, the counter electrode layer 104 and the counter electrode wire 105 are located at the middle end 102 of the substrate, and the counter electrode contact 106 is located at the end 103 of the substrate. According to an embodiment of the present invention, the counter electrode functions to form a closed current loop with the working electrode, providing a guarantee for converting blood glucose signals into electrochemical signals.

[0085] According to embodiments of the present invention, the material forming the counter electrode includes one or more of carbon, gold, silver, copper, and composite materials thereof. 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.

[0086] According to an embodiment of the present invention, the thickness of the counter electrode layer is 1 μm to 20 μm, preferably 5 μm to 15 μm, for example, 2 μm, 3 μm, 4 μm, 5 μm, 6 μm, 7 μm, 8 μm, 9 μm, 10 μm, 11 μm, 12 μm, 15 μm or 18 μm.

[0087] <Sensing layer>

[0088] According to an embodiment of the present invention, the sensing layer 115 is disposed on the working electrode layer 107 of the working electrode.

[0089] According to embodiments of the present invention, the material forming the sensing layer 115 includes one or more of glucose oxidase, glucose dehydrogenase, noble metals, transition metals, transition metal oxides, and true transition metal oxides. Exemplarily, the noble metals include gold and its composites, and 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, and iron and its composites.

[0090] According to embodiments of the present invention, the sensing layer is formed on the 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 deposition, etc.

[0091] According to an embodiment of the present invention, the thickness of the sensing layer is 1pm-20gm, preferably 1pm-10pm, for example, 1pm, 2pm, 3pm, 4pm, 5pm, 6pm, 7pm, 8pm, 9pm, 10pm, 11pm, 12pm, 15pm or 18pm.

[0092] According to an embodiment of the present invention, the analyte that the sensing layer can monitor is blood glucose.

[0093] <Electrode Setup>

[0094] In this invention, the working electrode, counter electrode, and reference electrode being spatially separated by a channel preferably means that the electrode layer of one electrode and the electrode wire of the other electrode, which are located on the same side of the substrate, are spatially separated by a channel.

[0095] According to an embodiment of the present invention, the electrodes located on the same side of the substrate are, for example, a working electrode and a reference electrode, wherein the working electrode layer 107 of the 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, and the reference electrode and the working electrode are spatially separated by a channel; or the working electrode layer 107 of the 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, and the reference electrode and the working electrode are spatially separated by a channel.

[0096] According to an embodiment of the present invention, the electrodes located on the same side of the substrate are, for example, a working electrode and a counter electrode, wherein the working electrode layer 107 of the 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, and the counter electrode and the working electrode are spatially separated by a channel; or the working electrode layer 107 of the 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, and the counter electrode and the working electrode are spatially separated by a channel.

[0097] According to an embodiment of the present invention, the electrodes located on the same side of the substrate are, for example, a counter electrode and a reference electrode, wherein 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, and the reference electrode and the counter electrode are spatially separated by a channel; or 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, and the reference electrode and the counter electrode are spatially separated by a channel. According to an embodiment of the present invention, when the electrodes located on the same side of the substrate are a working electrode and a reference electrode, the working electrode and the reference electrode are spatially separated by a channel. For example, when the working electrode layer 107 of the 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 working electrode wire 108 of the working electrode are spatially separated by a channel. When the working electrode layer 107 of the 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 working electrode layer 107 of the working electrode are spatially separated by a channel.

[0098] According to an embodiment of the present invention, when the electrodes located on the same side of the substrate are a working electrode and a counter electrode, the working electrode and the counter electrode are spatially separated by a channel. For example, when the working electrode layer 107 of the 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 working electrode wire 108 of the working electrode are spatially separated by a channel. When the working electrode layer 107 of the 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 working electrode layer 107 of the working electrode are spatially separated by a channel.

[0099] According to an embodiment of the present invention, when the electrodes located on the same side of the substrate are a counter electrode and a reference electrode, the counter electrode and the reference electrode are spatially separated by a channel. For example, 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. 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.

[0100] According to an embodiment of the present invention, when the electrodes located on the same side of the substrate are a working electrode and a reference electrode, the working electrode and the reference electrode are located on the same plane. Specifically, the working electrode layer 107, the working electrode wire 108, the 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; or, the 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 working electrode and the reference electrode is not located on the same plane; for example, the electrode layer of the working electrode and the electrode layer of the reference electrode are not located on the same plane, the electrode wire of the working electrode and the electrode wire of the reference electrode are located on the same plane, and the electrode contact of the working electrode and the electrode contact of the reference electrode are located on the same plane.

[0101] According to an embodiment of the present invention, when the electrodes located on the same side of the substrate are a working electrode and a counter electrode, the working electrode and the counter electrode are located on the same plane. Specifically, the working electrode layer 107, the working electrode wire 108, the 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; or, the 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 working electrode and the counter electrode is not located on the same plane; for example, the electrode layer of the working electrode and the electrode layer of the counter electrode are not located on the same plane, the electrode wire of the working electrode and the electrode wire of the counter electrode are located on the same plane, and the electrode contact of the working electrode and the electrode contact of the counter electrode are located on the same plane.

[0102] According to an embodiment of the present invention, when the electrodes located on the same side of the substrate 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; or, 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 not located on the same plane; for example, the electrode layer of the counter electrode and the electrode layer of the reference electrode are not located on the same plane, the electrode wire of the counter electrode and the electrode wire of the reference electrode are located on the same plane, and the electrode contact of the counter electrode and the electrode contact of the reference electrode are located on the same plane.

[0103] <Structure of the channel>

[0104] According to an embodiment of the present invention, as shown in FIG38, 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. The line segment "W" in FIG38 represents the width of the channel 114. The specific electrode layers and electrode wires need to be determined according to the different arrangements of the working electrode, reference electrode, and counter electrode inside the sensor. For example, the width of the channel 114 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 working electrode layer 107 of the working electrode; or the distance between the working electrode wire 108 of the working electrode and the counter electrode layer 104 of the counter electrode; or the distance between the working electrode wire 108 of the working electrode and the reference electrode layer 113 of the reference electrode; or the distance between the reference electrode wire 110 of the reference electrode and the working electrode layer 107 of the 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.

[0105] According to an embodiment of the present invention, the width of the channel 114 can be fixed or gradually varied; if fixed, the width of the channel is a fixed value in the range of 1 pm-280 pm; if gradually varied, the width of the channel 114 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 pm-280 pm, for example, varying within a width range of 50 pm-150 pm or varying within a width range of 80 pm-200 pm.

[0106] According to an embodiment of the present invention, the width of the channel is 1 pm-280 pm, preferably 50 pm-170 pm, for example, 20 pm, 30 pm, 40 pm, 50 pm, 60 pm, 70 pm, 80 pm, 90 pm, 100 pm, 120 pm, 130 pm, 140 pm, 150 pm, 160 pm, 170 pm, 180 pm, 190 pm, 200 pm, 210 pm, 220 pm, 230 pm, 240 pm, 250 pm, 260 pm, 270 pm, 280 pm, or a range consisting of the above two endpoint values. Research has found that when the channel width is between 1 μm and 280 μm, it can effectively separate the two types of electrodes located on the same side surface of the sensor, enabling two functional areas / electrode areas to function on the same side surface of the sensor, and improving the stability of the sensor. When the channel width is less than 10 μm, the narrow channel width may cause the two types of electrodes to come into contact, leading to short circuits between the electrodes and resulting in test data that is too high or too low, causing the sensor to fail. When the channel width is greater than 280 μm, the excessively wide channel width may cause the electrodes / electrode wires to be too narrow, potentially resulting in insufficient area of ​​the functional area / electrode area, or electrode breakage due to the narrow electrodes / electrode wires. This can cause data "jumping" or "jittering" during sensor testing, affecting the stability of the test data and ultimately causing sensor failure. According to an embodiment of the present invention, as shown in FIG38, the length of the channel 114 refers to the distance from the front end of the electrode layer located in the middle of the substrate to the connection point of the first and second sides of the substrate, that is, the length of the channel 114 is represented by the line segment "D" in FIG38. The specific electrode layer needs to be determined according to the different arrangements of the working electrode, reference electrode and counter electrode inside the sensor. For example, the length of the channel 114 is the distance from the front end of the working electrode layer of the 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.

[0107] According to an embodiment of the present invention, the length of the channel is 30 μm to 10,000 μm, for example, 30 μm, 40 μm, 50 μm, 60 μm, 70 μm, 80 μm, 90 μm, 100 μm, 110 μm, 120 μm, 130 μm, 140 μm, 150 μm, 160 μm, 170 μm, 180 μm, 190 μm, 200 μm, 210 μm, 220 μm, 230 μm, 240 μm, 250 μm, 260 μm, 270 μm, 280 μm, 300 μm, 320 μm, 350 μm, 380 μm, 400 μm, 450 μm, 500 μm, 550 μm, 600 μm, 700 μm, 800 μm, 900 μm. 1000pm> 1100pm> 1200pm, 1300pm, 1400pm, 1500pm, 2000pm, 2500pm, 3000pm, 3500pm, 4000pm, 4500pm, 5000pm, 5500pm, 6000pm, 6500pm, 7000pm, 7500pm, 8000pm, 8500pm, 9000pm, 9500pm or 10000pm. Studies have found that when the length of the groove is between 30 μm and 10,000 μm, it can effectively monitor the monitored object and provide good wearing comfort. When the length of the groove is less than 30 μm, 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 10,000 μm, due to excessive implantation, the wearer is prone to bleeding and pain, affecting the wearing experience.

[0108] 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.

[0109] <Structure of the Sensor>

[0110] According to an embodiment of the present invention, the analyte sensor is a three-electrode system, and the combination of the three electrodes can stabilize the potential. According to an embodiment of the present invention, the analyte sensor can continuously monitor for 7-360 days.

[0111] 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°.

[0112] 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.

[0113] <Protruding structure>

[0114] 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.

[0115] 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 Figure 34. According to an embodiment of the present invention, the number of the protrusion structures can be one or more, as shown in Figure 34.

[0116] <Dielectric layer>

[0117] According to an embodiment of the present invention, the analyte sensor further includes a dielectric layer 117, which is disposed on a substrate, an electrode or an electrode wire, and can be adjusted according to the structure of the sensor. The dielectric layer can serve as an insulator to protect the working electrode, the counter electrode and the reference electrode from damage.

[0118] For example, the dielectric layer is disposed on the surface of the working electrode or the working electrode wire to protect the working electrode from damage; the dielectric layer is disposed on the surface of the reference electrode or the reference electrode wire to protect the reference electrode from damage; the dielectric layer is disposed on the surface of the counter electrode or the counter electrode wire to protect the counter electrode from damage.

[0119] According to embodiments of the present invention, the material for 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. According to embodiments of the present invention, the dielectric layer is formed on the reference electrode, working electrode wire, or counter electrode wire using 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 deposition.

[0120] According to embodiments of the present invention, the thickness of the dielectric layer is 1 pm-1000 pm, preferably 10 pm-500 pm, for example, 10 pm, 20 pm, 50 pm, 80 pm, 100 pm, 20 pm, 50 pm, 80 pm, 200 pm, 220 pm, 250 pm, 260 pm, 280 pm, 300 pm, 320 pm, 350 pm, 380 pm, 400 pm, 420 pm, 450 pm, 480 pm, 500 pm, 600 pm, 700 pm, 800 pm, 900 pm, or 1000 pm. In all sensor configurations disclosed herein, the various electrodes can be isolated from each other through channels.

[0121] <Protective Layer>

[0122] 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.

[0123] 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.

[0124] According to an embodiment of the present invention, the protective layer may be a component, such as a filter.

[0125] According to an embodiment of the present invention, the material forming the protective layer may be an ethylene homopolymer or an ethylene copolymer.

[0126] According to an embodiment of the present invention, the thickness of the protective layer is 0.5 μm to 2000 μm, preferably 2 μm to 1000 μm, for example, 5 μm, 10 μm, 50 μm, 80 μm, 100 μm, 150 μm, 200 μm, 250 μm, 300 μm, 350 μm, 400 μm, 450 μm, 500 μm, 600 μm, 700 μm, 800 μm, 900 μm or 1000 μm.

[0127] 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.

[0128] <Sensor-related instructions>

[0129] According to embodiments of the present invention, the analyte sensor can use 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 different working electrode materials and sensing layer materials. According to embodiments of the present invention, the analyte sensor may contain an enzyme.

[0130] According to an embodiment of the present invention, the analyte sensor includes a 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 working electrode and the counter electrode, and a voltage loop is formed using the working electrode and the reference electrode. This allows the sensing layer on the working electrode to generate an electrochemical signal after reacting with blood glucose, thereby achieving the purpose of blood glucose monitoring. Furthermore, the strength of the generated electrochemical signal corresponds to the blood glucose concentration; that is, the higher the blood glucose concentration, the stronger the generated electrochemical signal. According to an embodiment of the present invention, the implantation length of the analyte sensor is 1 mm-20 nm, and the width is 0.05 mm-10 mm; preferably, the implantation length of the analyte sensor is 3 mm-18 mm, and the width is 0.10 mm-8 mm.

[0131] <Detection methods for determining analytes>

[0132] A detection method for determining an analyte, the detection method comprising:

[0133] 1) The analyte sensor is exposed to a fluid containing different concentrations of analyte. A voltage is applied to the sensor to obtain electrochemical signals with different signal intensities. The signal intensity of the electrochemical signal is proportional to the concentration of the analyte in the fluid.

[0134] 2) Correlate the signal intensity of the electrochemical signal with the concentration of the analyte in the fluid, and plot a standard curve of the electrochemical signal intensity and the concentration of the analyte;

[0135] 3) Expose the analyte sensor to a fluid containing the analyte being monitored, apply a voltage to the sensor to obtain an electrochemical signal, and obtain the concentration of the analyte being monitored in the fluid based on the signal intensity of the obtained electrochemical signal.

[0136] According to an embodiment of the present invention, the analyte is blood glucose.

[0137] 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.

[0138] 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.

[0139] Example 1

[0140] The structure of sensor electrode structure A in Example 1 is shown in Figures 1-4.

[0141] Figure 1 is a view of the sensor electrode structure A of Embodiment 1, wherein the left figure is a rear view of the sensor electrode structure A and the right figure is a front view of the sensor electrode structure A. As can be seen from Figure 1, the sensor electrode structure A includes a substrate 100: the substrate 100 has an L-shaped structure, and the substrate 100 includes a front end 101, a middle end 102, and a rear end 103;

[0142] The sensor electrode structure A includes a working electrode, which comprises a working electrode layer 107 located at the front end 101 of the substrate, a working electrode wire 108 located at the middle end 102 of the substrate, and a working electrode contact 109 located at the end 103 of the substrate; the sensor electrode structure A includes a sensing layer 115 located on the working electrode layer 107; the sensor electrode structure A includes a reference electrode, which comprises a reference electrode layer 113 and a reference electrode wire 110 located at the middle end 102 of the substrate, and a reference electrode contact 112 located at the end 103 of the substrate, and the reference electrode layer 113 is disposed on the reference electrode wire 110; the sensor electrode structure A includes a counter electrode, which comprises 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; the counter electrode is located on the back side of the sensor electrode structure A, and the reference electrode and the working electrode are located on the front side of the sensor electrode structure A.

[0143] The sensor electrode structure A includes a channel 114 located between the working electrode wire 108 of the working electrode and the reference electrode layer 113, and the working electrode and the reference electrode are separated by the channel 114. The width of the channel 114 is adjustable in the range of 1 pm to 280 pm, and the length of the channel is adjustable in the range of 30 pm to 10000 pm.

[0144] The sensor electrode structure A has an L shape, including a first side and a second side, and the connection between the first side and the second side forms an included angle, which is 85°-95°. A protrusion structure 118 is formed at the outer edge of the connection between the first side and the second side.

[0145] The sensor electrode structure A includes a protective layer 116, which is disposed on the outside of the sensor.

[0146] Figure 2 is a schematic cross-sectional view of sensor electrode structure A (AA) in Embodiment 1. Figure 3 is a schematic cross-sectional view of sensor electrode structure A (BB) in Embodiment 1. Figure 4 is a schematic cross-sectional view of sensor electrode structure A (CC) in Embodiment 1. As can be seen from Figures 2-4, sensor electrode structure A further includes a dielectric layer 117, which is disposed on the reference electrode, working electrode wire, and counter electrode wire. The above sensor electrode structure A was implanted into a human body for long-term testing. Figure 5 shows the blood glucose trend after 14 days of implantation. As can be seen from Figure 5, the sensor can achieve long-term monitoring of blood glucose.

[0147] Example 2

[0148] The structure of sensor electrode structure B in Example 2 is shown in Figures 6-9.

[0149] Figure 6 is a view of sensor electrode structure B in Embodiment 2, where the left figure is a rear view of sensor electrode structure B and the right figure is a front view of sensor electrode structure B. Figure 7 is a structural schematic diagram of cross-section AA of sensor electrode structure B in Embodiment 2. Figure 8 is a structural schematic diagram of cross-section BB of sensor electrode structure B in Embodiment 2. Figure 9 is a structural schematic diagram of cross-section CC of sensor electrode structure B in Embodiment 2. The composition of sensor electrode structure B is exactly the same as that of sensor electrode structure A, except that the positional relationship between the reference electrode and the working electrode located on the front of the sensor electrode structure changes. That is, sensor electrode structure B includes a working electrode, which includes a working electrode layer 107 and a working electrode wire 108 located at the middle 102 of the substrate, and a working electrode contact 109 located at the end 103 of the substrate.

[0150] The sensor electrode structure B includes a reference electrode, which includes a reference electrode layer 113 located at the front end 101 of the substrate, a reference electrode wire 110 located at the front end 101 and 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.

[0151] The sensor electrode structure B includes a channel 114 located between the working electrode layer 107 of the working electrode and the reference electrode wire 110 of the reference electrode, and the working electrode and the reference electrode are separated by the channel 114. The width of the channel 114 is adjustable in the range of 1 pm-280 rpm, and the length of the channel is adjustable in the range of 30 pm-10000 rpm.

[0152] Example 3

[0153] The structure of sensor electrode structure C in Example 3 is shown in Figures 10-13.

[0154] Figure 10 is a view of the sensor electrode structure C of Embodiment 3, wherein the left figure is a rear view of the sensor electrode structure C and the right figure is a front view of the sensor electrode structure C. As can be seen from Figure 10, the sensor electrode structure C includes a substrate 100: the substrate 100 has an L-shaped structure, and the substrate 100 includes a front end 101, a middle end 102, and a rear end 103;

[0155] The sensor electrode structure C includes a working electrode, which includes a working electrode layer 107 located at the front end 101 of the substrate, a working electrode wire 108 located at the middle end 102 of the substrate, and a working electrode contact 109 located at the end 103 of the substrate.

[0156] The sensor electrode structure C includes a sensing layer 115 located on the working electrode layer 107;

[0157] The sensor electrode structure C includes a reference electrode, which includes a reference electrode layer 113 located at the front end 101 of the substrate, a reference electrode wire 110 located at the front end 101 and 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.

[0158] The sensor electrode structure C includes a counter electrode, which includes a counter electrode layer 104 located at the middle end 102 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.

[0159] The reference electrode is located on the back side of the sensor electrode structure C, and the counter electrode and working electrode are located on the front side of the sensor electrode structure C. The sensor electrode structure C includes a channel 114 located between the working electrode wire 108 of the working electrode and the counter electrode layer 104, and the working electrode and the counter electrode are separated by the channel 114. The width of the channel 114 is adjustable in the range of 1 pm-280 nm, and the length of the channel is adjustable in the range of 30 pm-10000 nm.

[0160] The sensor electrode structure C has an L shape, including a first side and a second side, and the connection between the first side and the second side forms an angle, the angle being 85°-95°. A protruding structure 118 is formed at the outer edge of the connection between the first side and the second side.

[0161] The sensor electrode structure C includes a protective layer 116, which is disposed on the outside of the sensor.

[0162] Figure 11 is a schematic cross-sectional view of the sensor electrode structure C of Embodiment 3, showing section AA. Figure 12 is a schematic cross-sectional view of the sensor electrode structure C of Embodiment 3, showing section BB. Figure 13 is a schematic cross-sectional view of the sensor electrode structure C of Embodiment 3, showing section CC. As can be seen from Figures 11-13, the sensor electrode structure C further includes a dielectric layer 117, which is disposed on the reference electrode, the working electrode wire, and the counter electrode wire.

[0163] Example 4

[0164] The structure of sensor electrode structure D in Embodiment 4 is shown in Figures 14-17. Figure 14 is a view of sensor electrode structure D in Embodiment 4, where the left figure is a rear view of sensor electrode structure D and the right figure is a front view of sensor electrode structure D. Figure 15 is a structural schematic diagram of cross-section AA of sensor electrode structure D in Embodiment 4. Figure 16 is a structural schematic diagram of cross-section BB of sensor electrode structure D in Embodiment 4. Figure 17 is a structural schematic diagram of cross-section C-C' of sensor electrode structure D in Embodiment 4. The composition of sensor electrode structure D is exactly the same as that of sensor electrode structure C, except that the positional relationship between the counter electrode and the working electrode on the front side of the sensor electrode structure changes. That is, sensor electrode structure D includes a working electrode, which includes a working electrode layer 107 and a working electrode wire 108 located at the middle 102 of the substrate, and a working electrode contact 109 located at the end 103 of the substrate.

[0165] The sensor electrode structure D includes a counter electrode, which 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.

[0166] The sensor electrode structure D includes a channel 114 located between the working electrode layer 107 of the working electrode and the counter electrode conductive layer 105 of the counter electrode, and the working electrode and the counter electrode are separated by the channel 114. The width of the channel 114 is adjustable in the range of 1 mm to 280 mm, and the length of the channel is adjustable in the range of 30 mm to 10000 mm.

[0167] Example 5

[0168] The structure of the sensor electrode structure E in Example 5 is shown in Figures 18-21.

[0169] Figure 18 is a view of the sensor electrode structure E of Embodiment 5, wherein the left figure is a rear view of the sensor electrode structure E, and the right figure is a front view of the sensor electrode structure E. As can be seen from Figure 18, the sensor electrode structure E includes a substrate 100: the substrate 100 has an L-shaped structure, and the substrate 100 includes a front end 101, a middle end 102, and a rear end 103;

[0170] The sensor electrode structure E includes a working electrode, which includes a working electrode layer 107 located at the front end 101 of the substrate, a working electrode wire 108 located at the middle end 102 of the substrate, and a working electrode contact 109 located at the end 103 of the substrate.

[0171] The sensor electrode structure E includes a sensing layer 115 located on the working electrode layer 107;

[0172] The sensor electrode structure E includes a reference electrode, which includes a reference electrode layer 113 located at the front end 101 of the substrate, a reference electrode wire 110 located at the front end 101 and the middle end 102 of the substrate, and a reference electrode contact 112 located at the end 103 of the substrate, and the reference electrode layer 113 is disposed on the reference electrode wire 110.

[0173] The sensor electrode structure E includes a counter electrode, which includes a counter electrode layer 104 located at the middle end 102 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;

[0174] The working electrode is located on the back side of the sensor electrode structure E, and the reference electrode and counter electrode are located on the front side of the sensor electrode structure E. The sensor electrode structure E includes a channel 114 located between the reference electrode wire 110 of the reference electrode and the counter electrode layer 104 of the counter electrode, and the channel 114 separates the reference electrode and the counter electrode. The width of the channel 114 is adjustable in the range of 1 μm to 280 μm, and the length of the channel is adjustable in the range of 30 μm to 10000 μm.

[0175] The sensor electrode structure E has an L shape, including a first side and a second side, and the connection between the first side and the second side forms an angle, the angle being 85°-95°. A protrusion structure 118 is formed at the outer edge of the connection between the first side and the second side.

[0176] The sensor electrode structure E includes a protective layer 116, which is disposed on the outside of the sensor.

[0177] Figure 19 is a schematic cross-sectional view of the sensor electrode structure E in Embodiment 5, showing section AA. Figure 20 is a schematic cross-sectional view of the sensor electrode structure E in Embodiment 5, showing section BB. Figure 21 is a schematic cross-sectional view of the sensor electrode structure E in Embodiment 5, showing section CC. As can be seen from Figures 19-21, the sensor electrode structure E further includes a dielectric layer 117, which is disposed on the reference electrode, the working electrode wire, and the counter electrode wire. Embodiment 6

[0178] The structure of the sensor electrode structure F in Example 6 is shown in Figures 22-25.

[0179] Figure 22 is a view of the sensor electrode structure F of Embodiment 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. Figure 23 is a structural schematic diagram of the AA section of the sensor electrode structure F of Embodiment 6. Figure 24 is a structural schematic diagram of the BB section of the sensor electrode structure F of Embodiment 6. Figure 25 is a structural schematic diagram of the CC section of the sensor electrode structure F of Embodiment 6. The composition of the sensor electrode structure F is exactly the same as that of the sensor electrode structure E, except that the positional relationship between the counter electrode and the working electrode on the front of the sensor electrode structure changes. That is, the sensor electrode structure F includes a reference electrode, which includes a reference electrode layer 113 located at the middle end 102 of the substrate and a reference electrode wire 110 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.

[0180] The sensor electrode structure F includes a counter electrode, which 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;

[0181] The sensor electrode structure F includes a channel 114 located between the reference electrode layer 113 of the reference electrode and the counter electrode wire 105 of the counter electrode, and the reference electrode and the counter electrode are separated by the channel 114. The width of the channel 114 is adjustable in the range of 1 μm to 280 μm, and the length of the channel is adjustable in the range of 30 μm to 10000 μm.

[0182] Example 7

[0183] The structure of the sensor electrode structure G in Example 7 is shown in Figures 26-29.

[0184] Figure 26 is a view of the sensor electrode structure G of Embodiment 7, wherein the left figure is a rear view of the sensor electrode structure G, the middle figure is a view of the middle layer of the sensor electrode structure G, and the right figure is a front view of the sensor electrode structure G. As can be seen from Figure 26, the sensor electrode structure G includes a substrate 100: the substrate 100 has an L-shaped structure, and the substrate 100 includes a front end 101, a middle end 102, and a rear end 103;

[0185] The sensor electrode structure G includes a working electrode, which includes a working electrode layer 107 located at the front end 101 of the substrate, a working electrode wire 108 located at the middle end 102 of the substrate, and a working electrode contact 109 located at the end 103 of the substrate.

[0186] The sensor electrode structure G includes a sensing layer 115 located on the working electrode layer 107;

[0187] The sensor electrode structure G includes a reference electrode, which comprises a reference electrode layer 113 and a reference electrode wire 110 located at the middle 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 sensor electrode structure G also includes a counter electrode, which comprises a counter electrode layer 104 located at the front 101 of the substrate, a counter electrode wire 105 located at the middle 102 of the substrate, and a counter electrode contact 106 located at the end 103 of the substrate.

[0188] The counter electrode is located on the back side of the sensor electrode structure G, the working electrode is located in the middle of the sensor electrode structure G, and the reference electrode is located on the front side of the sensor electrode structure G. That is, the working electrode and the reference electrode located on the same side of the substrate 100 are not located on the same plane.

[0189] The sensor electrode structure G includes a channel 114 located between the working electrode wire 108 of the working electrode and the reference electrode layer 113, and the working electrode and the reference electrode are separated by the channel 114. The width of the channel 114 is adjustable in the range of 1 μm-280 μm, and the length of the channel is adjustable in the range of 30 μm-10000 μm.

[0190] The sensor electrode structure G has an L-shape, including a first side and a second side, and the connection between the first side and the second side forms an included angle of 85°-95°. A protruding structure 118 is formed at the outer edge of the connection between the first side and the second side.

[0191] The sensor electrode structure G includes a protective layer 116, which is disposed on the outside of the sensor.

[0192] Figure 27 is a schematic diagram of the sensor electrode structure G of Embodiment 7, cross-section AA. Figure 28 is a schematic diagram of the sensor electrode structure G of Embodiment 7, cross-section BB. Figure 29 is a schematic diagram of the sensor electrode structure G of Embodiment 7, cross-section C-C'. As can be seen from Figures 27-29, the sensor electrode structure E further includes a dielectric layer 117, which is disposed on the reference electrode, the working electrode wire, and the counter electrode wire.

[0193] Example 8

[0194] The structure of the sensor electrode structure H in Example 8 is shown in Figures 30-33.

[0195] Figure 30 is a view of the sensor electrode structure H of Embodiment 8, where the left figure is a rear view of the sensor electrode structure H, the middle figure is a view of the middle layer of the sensor electrode structure H, and the right figure is a front view of the sensor electrode structure H. Figure 31 is a structural schematic diagram of the AA section of the sensor electrode structure H of Embodiment 8. Figure 32 is a structural schematic diagram of the BB section of the sensor electrode structure H of Embodiment 8. Figure 33 is a structural schematic diagram of the C-C' section of the sensor electrode structure H of Embodiment 8.

[0196] The composition of the sensor electrode structure H is exactly the same as that of the sensor electrode structure G. The difference is that the positional relationship between the reference electrode and the working electrode located on the front and middle layers of the sensor electrode structure changes. That is, the counter electrode is located on the back of the sensor electrode structure G, the reference electrode is located in the middle layer of the sensor electrode structure G, and the working electrode is located on the front of the sensor electrode structure G. The working electrode and the reference electrode located on the same side of the substrate 100 are not located on the same plane.

[0197] Specifically, the sensor electrode structure H includes a working electrode, which includes a working electrode layer 107 and a working electrode wire 108 located at the middle end 102 of the substrate, and a working electrode contact 109 located at the end 103 of the substrate;

[0198] The sensor electrode structure H includes a reference electrode, which includes a reference electrode layer 113 located at the front end 101 of the substrate, a reference electrode wire 110 located at the front end 101 and 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.

[0199] The sensor electrode structure H includes a channel 114 located between the working electrode layer 107 of the working electrode and the reference electrode wire 110 of the reference electrode, and the working electrode and the reference electrode are separated by the channel 114. The width of the channel 114 is adjustable in the range of 1 μm to 280 μm, and the length of the channel is adjustable in the range of 30 μm to 10000 μm.

[0200] Figure 35 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 35, the sensor portion without the protruding structure is located on the outside of the auxiliary device.

[0201] Figure 36 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 36, 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.

[0202] Figure 37 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 37, 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.

[0203] Comparative Example 1

[0204] Other structures are as shown in Example 1, 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 working electrode wire and the reference electrode to come into contact, making a short circuit between them highly likely. Figure 39 shows the trend of blood glucose changes over one day after the sensor was implanted in a normal human body. As can be seen from Figure 39, due to the excessively narrow channel width in the sensor, the working electrode and the reference electrode are highly prone to short circuits, leading to elevated blood glucose levels. Normal blood glucose readings are generally between 3.9 mM and 6.1 mM.

[0205] Comparative Example 2

[0206] Other structures are as shown in Example 1, the only difference being that the width of the channel 114 in the sensor of Comparative Example 2 is greater than 280 μm. This results in the electrodes / electrode wires being too narrow, which can easily cause open circuits. The trend of blood glucose changes over 2 days after the sensor was implanted in a normal human body is shown in Figure 40. As can be seen from Figure 40, the excessively wide channel in the sensor leads to the electrodes / electrode wires being too narrow, which causes data "jumps" or "jitter" during the blood glucose test, affecting the stability of the test data.

[0207] 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

Claims 1. An analyte sensor, the analyte sensor comprising a substrate, a working electrode, a reference electrode, a counter electrode, and a sensing layer; the sensing layer being disposed on the working electrode; the working electrode, the reference electrode, and the counter electrode being disposed on opposite sides of the substrate, and the two electrodes located on the same side of the substrate being spatially separated by a channel; The width of the channel is 1 pm to 280 pm; the length of the channel is 30 pm to 10000 pm.

2. The analyte sensor according to claim 1, wherein, The working electrode and the reference electrode are disposed on a first surface of the substrate and are spatially separated by a channel. The counter electrode is disposed on a second surface of the substrate opposite to the first surface. Alternatively, the working electrode and the counter electrode are disposed on a first surface of the substrate and are spatially separated by a channel. The reference electrode is disposed on a second surface of the substrate opposite to the first surface. Preferably, the two electrodes located on the same side of the substrate are located on the same plane; Alternatively, the two electrode portions located on the same side of the substrate may be situated on the same plane.

3. The analyte sensor according to claim 1 or 2, wherein, The substrate includes a front end, a middle end, and an end end, which are sequentially connected. The substrate has an L-shape, which includes a first side and a second side, and the connection between the first side and the second side forms an included angle of 45°-135°. The front end is located on the first side and at the non-connected end of the first side. The end end is located on the second side and at the non-connected end of the second side. The middle end is located on the first side and the second side, and at the connection end of the first side and the connection end of the second side.

4. The analyte sensor according to any one of claims 1-3, wherein, The working electrode includes a working electrode layer, a working electrode wire, and a working electrode contact. The working electrode layer is connected to the working electrode contact via the working electrode wire. The working electrode layer is located at the front end of the substrate, the working electrode wire is located at the middle of the substrate, and the working electrode contact is located at the end of the substrate. Alternatively, the working electrode layer and the working electrode wire are located at the middle of the substrate, and the working electrode contact is located at the end of the substrate. The reference electrode includes a reference electrode layer, a reference electrode wire, and a reference electrode contact. The reference electrode layer is disposed on the reference electrode wire, and the reference electrode wire is connected to the reference electrode contact. The reference electrode layer is located at the front end of the substrate, the reference electrode wire is located at the front end and middle end of the substrate, and the reference electrode contact is located at the end of the substrate; or, the reference electrode layer and the reference electrode wire are located at the middle end of the substrate, and the reference electrode contact is located at the end of the substrate. The counter electrode includes a counter electrode layer, a counter electrode wire, and a counter electrode contact. The counter electrode layer is connected to the counter electrode contact via the counter electrode wire. The counter electrode layer is located at the front end of the substrate, the counter electrode wire is located at the middle of the substrate, and the counter electrode contact is located at the end of the substrate. Alternatively, the counter electrode layer and the counter electrode wire are located at the middle of the substrate, and the counter electrode contact is located at the end of the substrate. Preferably, the working electrode mainly functions to react with blood glucose; the reference electrode forms a voltage loop with the working electrode to ensure the conversion of blood glucose signals into electrochemical signals, and the reference electrode stabilizes the potential, thus enabling the analyte sensor to perform continuous and stable monitoring; the counter electrode forms a current closed loop with the working electrode to ensure the conversion of blood glucose signals into electrochemical signals.

5. The analyte sensor according to any one of claims 1-4, wherein, The working electrode includes a working electrode layer, and a sensing layer is disposed on the working electrode layer. Preferably, the analyte that the sensing layer can monitor is blood glucose.

6. The analyte sensor according to any one of claims 1-5, wherein, The electrode layer of one of the two electrodes located on the same side of the substrate and the electrode wire of the other electrode are spatially separated by a channel. Preferably, the width of the channel is fixed or gradually varies.

7. The analyte sensor according to any one of claims 1-6, wherein, The analyte sensor has an L-shape, wherein the L-shape includes 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 being 45°-135°. Preferably, 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. 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.

8. The analyte sensor according to any one of claims 1-7, wherein, A protruding structure is formed at the junction of the first side and the second side. Preferably, a protruding structure is formed on the outer edge of the junction of the first side and the second side.

9. The analyte sensor according to any one of claims 1-8, wherein, The analyte sensor also includes a dielectric layer disposed on the substrate, electrode, or electrode wire. The dielectric layer serves as an insulator to protect the working electrode, counter electrode, and reference electrode from damage. Preferably, the analyte sensor further includes a protective layer disposed on the outermost layer of the sensor.

10. The analyte sensor according to any one of claims 1-9, wherein, The front end and part of the middle end of the analyte sensor are implanted in the body. A current loop is formed by the working electrode and the counter electrode, and a voltage loop is formed by the working electrode and the reference electrode. This allows the sensing layer on the working electrode to generate an electrochemical signal after reacting with blood glucose, thereby achieving the purpose of monitoring blood glucose. Preferably, the implantation length of the analyte sensor is limn-20 mm and the width is 0.05 mm-10 mm.

Images