Continuous analyte sensor and manufacturing method

Abstract

The invention provides a continuous analyte sensor. The continuous analyte sensor comprises a substrate, an electrode region and an insulating layer, the electrode region covers the substrate, and the electrode region is covered with the insulating layer; wherein the edge of the electrode area is provided with a separation groove, the separation groove is filled with an insulating medium, and the insulating medium separates the edge of the electrode area from the outside. Meanwhile, the invention further provides a manufacturing method of the continuous analyte sensor. Compared with the prior art, the continuous analyte sensor and the manufacturing method provided by the invention have the advantages that the waterproof capability of the continuous analyte sensor can be improved, and the risk of short circuit failure of the continuous analyte sensor is reduced.

Description

Technical Field

[0001] The present invention relates to the technical field of medical auxiliary equipment, and in particular to a continuous analyte sensor and a manufacturing method thereof. Background Art

[0002] Sensors that can continuously measure molecular analytes offer great potential in personalized health monitoring, early disease detection, and hospitalization. Take the sensors used in CGMS (continuous glucose monitoring system) as an example. After the sensor is implanted in the human body, the detection site on the sensor reacts with the substance in the tissue fluid to generate a corresponding signal and send it to the outside through a transmitter, thereby monitoring and feeding back the real-time dynamic blood glucose value.

[0003] At present, when manufacturing such sensors, it is necessary to first print the conductive layer on the substrate, then cover the insulating layer, dot the enzyme, and then cut the substrate to complete the manufacture of a single sensor.

[0004] like Figure 1 As shown in the figure, after the conductive layer printing and other steps are completed, it is necessary to cut along the outline cutting line on the substrate to cut out the sensor of the required shape and size. However, after cutting the substrate, the material on the electrode area of ​​the conductive layer is easy to leak out from the side (such as carbon leakage), causing the circuit between the electrodes to be easily connected after the sensor contacts water, resulting in a short circuit defect. Summary of the invention

[0005] Aiming at the technical problem that after the sensor in the prior art is manufactured, the material on the conductive layer is easy to leak out, thereby affecting the waterproof ability of the sensor, the present invention provides a continuous analyte sensor, which is covered with an insulating layer on the electrode area and an insulating medium is arranged at the edge of the electrode area, so that after contacting water, the circuit between the electrodes will not be connected, so that there will be no short circuit, and the waterproof ability is improved.

[0006] A continuous analyte sensor comprises a substrate, an electrode region and an insulating layer; The electrode area is covered on the substrate, and the insulating layer is covered on the electrode area; Wherein, a separation groove is arranged at the edge of the electrode area, and the separation groove is filled with an insulating medium, and the insulating medium isolates the edge of the electrode area from the outside.

[0007] Preferably, it further comprises an isolation region, which covers the substrate and is located outside the separation groove, and the separation groove separates the electrode region from the isolation region.

[0008] Preferably, the separation grooves are provided on both side edges of the electrode area, and each of the separation grooves is filled with the insulating medium.

[0009] Preferably, the continuous analyte sensor comprises a connection end, an implantation end, and a middle portion between the connection end and the implantation end; The separation groove is opened at the edge of the electrode area in the middle part, and the insulating medium isolates the electrode area in the middle part from the outside.

[0010] Preferably, both ends of the separation groove partially extend to the connection end and the implantation end along the length direction of the continuous analyte sensor respectively; And the ends of both ends of the separation groove extend to the edge of the substrate along the width direction of the continuous analyte sensor respectively.

[0011] A method for manufacturing a continuous analyte sensor comprises the following steps: printing a conductive layer on a substrate; The conductive layer is cut and separated to form separation grooves; the separation grooves separate the conductive layer into an electrode area located inside and an isolation area located at the edge; printing an insulating medium on the conductive layer; The substrate is cut along a cutting line of the outer contour to form a single continuous analyte sensor, wherein the cutting line of the outer contour is located outside the separation groove.

[0012] Preferably, when the conductive layer is cut and separated, both side edges of the conductive layer are cut and separated.

[0013] Preferably, the continuous analyte sensor comprises a connection end, an implantation end, and a middle portion between the connection end and the implantation end; When the conductive layer is cut and separated, the conductive layer located in the middle portion is cut along the length direction of the continuous analyte sensor, and the conductive layer located at the connection end and the implantation end is cut along the width direction of the continuous analyte sensor to form the separation groove.

[0014] Preferably, before printing the conductive layer on the substrate, the method further includes: opening a hole on the substrate and placing a conductive material in the hole; When printing the conductive layer on the substrate, the conductive layer is printed on the upper and lower surfaces of the substrate respectively; When the conductive layer is cut and separated, the conductive layers located on the upper and lower surfaces of the substrate are cut and separated respectively.

[0015] Preferably, when the conductive layer is cut and separated, the electrode area is also cut and separated, and the electrode area is separated to form a plurality of electrode units.

[0016] Compared with the prior art, the continuous analyte sensor provided by the present invention includes a substrate, an electrode area and an insulating layer; the electrode area is covered on the substrate, and the electrode area is covered with the insulating layer; wherein a separation groove is provided at the edge of the electrode area, and the separation groove is filled with an insulating medium, and the insulating medium isolates the edge of the electrode area from the outside. The continuous analyte sensor is provided with the separation groove at the edge of the electrode area, and the separation groove is filled with an insulating medium, so that the edge of the electrode area can be blocked by the insulating medium, so that the substance on the electrode area will not leak out, and the electrode area is also covered with the insulating layer, so that comprehensive protection can be provided. The continuous analyte sensor will not cause the circuit between the electrodes to be conductive after being exposed to water, and will not have a short circuit, thereby improving the waterproof ability of the sensor. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0018] Figure 1 A schematic diagram of the structure of a continuous analyte sensor formed by cutting in the prior art (the right side is the continuous analyte sensor after cutting); Figure 2 A schematic diagram of the structure of a continuous analyte sensor provided by an embodiment before cutting; Figure 3 for Figure 2 A schematic diagram of the structure of a local area on the continuous analyte sensor shown; Figure 4 A schematic diagram of the exploded structure of a continuous analyte sensor provided by an embodiment; Figure 5 A partial schematic diagram of a substrate provided in a method for manufacturing a continuous analyte sensor provided by an embodiment; Figure 6 A schematic diagram of the structure after printing a conductive layer on a substrate in a method for manufacturing a continuous analyte sensor provided by an embodiment; Figure 7 A schematic diagram of the structure after the conductive layer is cut and separated in the manufacturing method of the continuous analyte sensor provided by an embodiment; Figure 8 A schematic diagram of the structure after printing an insulating medium on a guide layer in a method for manufacturing a continuous analyte sensor provided by an embodiment; Fig. 9 for Figure 8 A schematic diagram of the structure of the cutting line of the outer contour and the position of the separation groove in the structure shown; Fig.10 The present invention is a schematic structural diagram of a method for manufacturing a continuous analyte sensor provided in an embodiment after a substrate is cut along a cutting line of an outer contour. DETAILED DESCRIPTION

[0019] In order to enable those skilled in the art to better understand the technical solutions in this application, the technical solutions in the embodiments of this application will be clearly and completely described below. Obviously, the described embodiments are only part of the embodiments of this application, not all of them. Based on the embodiments in this application, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of this application.

[0020] It should be noted that when a component is referred to as being "fixed on", "installed on" or "set on" another component, it can be directly on the other component or indirectly set on the other component; when a component is "connected" to another component, or a component is referred to as being "connected to" another component, it can be directly connected to the other component or indirectly connected to the other component.

[0021] It should be understood that the terms "length", "width", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", etc., indicating the orientation or position relationship, are based on the orientation or position relationship shown in the drawings, and are only for the convenience of describing the present application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be understood as a limitation on the present application.

[0022] In addition, the terms "first" and "second" are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Therefore, a feature defined as "first" or "second" may explicitly or implicitly include one or more of the features. In the description of this application, "multiple" and "several" mean two or more, unless otherwise clearly and specifically defined.

[0023] It should be noted that the structures, proportions, sizes, etc. illustrated in the drawings of this specification are only used to match the contents disclosed in the specification for people familiar with this technology to understand and read, and are not used to limit the conditions under which this application can be implemented. Therefore, they have no substantive technical significance. Any structural modification, change in proportional relationship or adjustment of size should still fall within the scope of the technical content disclosed in this application without affecting the effects and purposes that can be achieved by this application.

[0024] The present invention provides a continuous analyte sensor, which includes a substrate, an electrode area and an insulating layer; the electrode area is covered on the substrate, and the electrode area is covered with the insulating layer; wherein a separation groove is provided at the edge of the electrode area, and the separation groove is filled with an insulating medium, and the insulating medium isolates the edge of the electrode area from the outside. The continuous analyte sensor is provided with the separation groove at the edge of the electrode area, and the separation groove is filled with an insulating medium, so that the edge of the electrode area can be blocked by the insulating medium, so that the substance on the electrode area will not leak out, and the electrode area is also covered with the insulating layer, so that comprehensive protection can be performed. The continuous analyte sensor will not cause the circuit between the electrodes to be conductive after being exposed to water, and will not have a short circuit, thereby improving the waterproof ability of the sensor.

[0025] Please refer to Figures 2 to 4 In one embodiment, a continuous analyte sensor 100 is provided. Specifically, in one embodiment, the continuous analyte sensor 100 is a continuous analyte sensor used in an implantable continuous monitoring system for monitoring indicators such as blood glucose, lactate, ketones, etc.

[0026] The continuous analyte sensor 100 includes a substrate 10, an electrode area 20 and an insulating layer 30, wherein the electrode area 20 is covered on the substrate 10, and the electrode area 20 is covered with the insulating layer 30. A separation groove 40 is provided at the edge of the electrode area 20, and the separation groove 40 is filled with an insulating medium, and the insulating medium blocks the edge of the electrode area 20 from the outside. In other words, a groove is provided at the edge area of ​​the electrode area 20 on the substrate 10, and the groove is filled with an insulating medium, so that the edge of the electrode area 20 is shielded and covered by the insulating medium, so that the edge of the electrode area 20 will not be exposed to the outside, thereby completely blocking the edge of the electrode area 20 from the outside. After the continuous analyte sensor 100 is exposed to water, the water will only contact the insulating medium, and will not contact the electrode area 20, so that the electrodes will not be connected to each other.

[0027] It is understandable that in the prior art, when manufacturing a continuous analyte sensor, when the conductive layer is printed on the substrate and the substrate is subsequently cut, due to the limitations of the process equipment, the material on the electrode area of ​​the conductive layer is easily leaked out (such as carbon leakage) after cutting. In the subsequent use process, when the leaked part comes into contact with water, it is easy to make the circuit between the electrodes conductive, resulting in a short circuit defect.

[0028] The continuous analyte sensor 100 provided in the present embodiment is covered with the insulating layer 30 on the electrode area 20, and the separation groove 40 is provided at the edge of the electrode area 20, and the separation groove 40 is filled with the insulating medium, thereby completely isolating the electrode area 20 from the outside world, so that the electrode area 20 inside does not leak out, so that after being exposed to water, it is not easy for the circuits between the electrodes to be turned on, so that the continuous analyte sensor 100 is not prone to short circuit failure, thereby improving the waterproof performance of the continuous analyte sensor 100, thereby achieving more stable performance requirements.

[0029] Specifically, in one embodiment, the separation groove 40 can be formed by cutting the conductive layer on the substrate 10 using a cutting device, such as a laser cutting device or a laser cutting device.

[0030] Preferably, in one embodiment, the continuous analyte sensor 100 further includes an isolation region 50, which covers the substrate 10 and is located outside the separation groove 40, and the separation groove 40 isolates the electrode region 20 from the isolation region 50. That is, in this embodiment, the isolation region 50 is further disposed outside the separation groove 40, and the separation groove 40 completely isolates the electrode region 20 from the isolation region 50, and the two are not conductive to each other, so that even if the isolation region 50 is wetted, it will not affect the electrode region 20.

[0031] Specifically, in one embodiment, when the continuous analyte sensor 100 is manufactured, after the conductive layer is printed on the substrate 10, the conductive layer can be offset inward at the position where it meets the cutting line 11 of the outer contour of the substrate 10 to obtain the inner cutting line of the outer contour, and the inner cutting line can be cut and separated by a cutting device to form the separation groove 40, so that the conductive layer is separated by the separation groove 40 to form the electrode area 20 located on the inner side and the isolation area 50 located on the edge, so that the part of the conductive layer that needs to be connected with the contact and the detection end (i.e., the electrode area 20) is all within the separation groove 40. When the sensor shape is subsequently cut, since the electrode area 20 is already within the outer contour, the cutting process will not leak the electrode area 20 (what is actually cut is the insulating medium in the separation groove 40 or the isolated isolation area 50). In the final cut product, only the insulating medium in the separation groove 40 or the isolation area 50 of the continuous analyte sensor 100 will leak out, while the electrode area 20 will not leak out, thereby improving the waterproof capability.

[0032] The outer contour cutting line 11 refers to a marking line along which the substrate 10 needs to be cut in the subsequent manufacturing process of the continuous analyte sensor. The outer contour cutting line 11 can be directly opened on the substrate 10 or defined by a cutting trajectory in a cutting device. For example, the outer contour cutting line 11 can be directly formed on the substrate 10; or the outer contour cutting line 11 is not directly set on the substrate 10, but is set as a cutting trajectory in a cutting device. When the substrate 10 is positioned in the cutting device, the cutting device cuts the substrate 10 according to a predetermined cutting trajectory.

[0033] Preferably, in one embodiment, the separation groove 40 is filled with the insulating medium, and the separation groove 40 is completely filled with the insulating medium, thereby ensuring that any area in the separation groove 40 can well block the electrode area 20, further improving the waterproof capability.

[0034] It is understandable that, in the manufacturing process of the continuous analyte sensor, after the conductive layer 20 is printed on the substrate 10, the insulating layer needs to be printed later. Preferably, in one embodiment, when the continuous analyte sensor is manufactured, before the insulating layer printing step, the separation groove 40 can be opened first, and then the insulating layer printing can be performed, so that the insulating medium can flow into the separation groove 40 when the insulating layer is printed, thereby simplifying the overall process, and no additional step is required to add the insulating medium to the separation groove 40.

[0035] Preferably, in one embodiment, the separation grooves 40 are provided at both side edges of the electrode region 20, and each of the separation grooves 40 is filled with the insulating medium. Figure 3 Taking the continuous analyte sensor shown as an example, the separation grooves 40 are provided on both the left and right sides of the electrode area 20 to ensure that there is no risk of leakage on both the left and right sides of the electrode area 20.

[0036] Preferably, in one embodiment, the continuous analyte sensor 100 includes a connection end 101, an implantation end 102, and a middle portion 103 located between the connection end 101 and the implantation end 102. The connection end 101, the implantation end 102, and the middle portion 103 refer to different position areas on the continuous analyte sensor 100. For example, the continuous analyte sensor 100 can be divided into the connection end 101, the middle portion 103, and the implantation end 102 along the length direction of the continuous analyte sensor 100. The substrate 10, the electrode area 20, and the insulating layer 30 are different layers in the thickness direction of the continuous analyte sensor 100. The connection end 101, the implantation end 102, and the middle portion 103 can all include the substrate 10, the electrode area 20, and the insulating layer 30. In the continuous analyte sensor 100, the connection end 101 is mainly used for connecting with the transmitter, and the electrical connection contacts and other components are arranged at the connection end 101; and the implant end 102 is used for implanting under the skin of the human body and contacting with the interstitial fluid. The implant end 102 may include a working electrode and a reference electrode, and the electrodes are loaded with enzymes and other reaction reagents. The biocompatible permeable membrane may be included in the implant end 102; and the middle part 103 is the part for connecting the two places. After the continuous analyte sensor is used, the middle part 103 is usually exposed between the skin and the bottom surface of the transmitter. Therefore, the middle part 103 is also a part that is relatively easier to contact with external water. Preferably, in the middle part 103, the length of the separation groove 40 is not less than the length of the middle part 103. It can be understood that, since after use, the connection end 101 is located inside the transmitter and is sealed, and the implant end 102 is implanted under the skin of the human body, the above two parts will not be exposed to the outside. The middle part 103 is located between the human skin and the bottom surface of the transmitter, which is exposed to the outside and needs to have a waterproof effect. Therefore, in the entire continuous analyte sensor, the conductive layer in the middle part 103 is easily exposed to water and easily causes a short circuit in the continuous analyte sensor. In this embodiment, the separation groove 40 is mainly arranged in the middle part 103. Further, the length of the separation groove 40 is set to be not less than the length of the middle part 103, so that at least in the middle part 103, the separation groove 40 can completely separate the conductive layer, thereby completely blocking the edge of the electrode area 20 from the outside through the insulating medium, thereby improving the waterproof effect of the continuous analyte sensor finally produced. After the continuous analyte sensor is implanted, the waterproof effect of the part of the continuous analyte sensor exposed between the skin and the bottom surface of the transmitter can be improved.

[0037] Preferably, in one embodiment, the two ends of the separation groove 40 partially extend to the connection end 101 and the implantation end 102 along the length direction of the continuous analyte sensor 100; and the ends of the two ends of the separation groove 40 extend to the edge of the substrate 10 along the width direction of the continuous analyte sensor 100. Specifically, in one embodiment, the separation groove 40 includes a groove body 41 and groove ends 42 located at both ends of the groove body 41, the groove body 41 is located in the middle part 103, and extends along the length direction of the continuous analyte sensor 100 (for example, Figure 2 The two groove ends 42 are located at the connection end 101, the implant end 102, and the groove end 42 is at least partially along the width direction of the continuous analyte sensor 100 (for example, as Figure 2 The separation groove 40 extends in the horizontal direction (as shown in the figure) and extends to the edge of the substrate 10. That is to say, in this embodiment, both ends of the separation groove 40 extend to the connection end 101 and the implantation end 102, and both ends of the separation groove 40 extend to the edge of the substrate 10, so that the conductive layer can be completely separated. With this structure, it can be avoided that the separation groove 40 fails to completely separate the conductive layer in the middle part 103 due to factors such as processing errors. Specifically, in one embodiment, the groove end 42 is an arc-shaped structure as a whole.

[0038] It should be noted that the electrode area 20 is mainly used to connect and conduct the electrode with the electrical contact. The electrode area 20 can be printed on the upper and lower surfaces of the substrate 10, respectively, and the electrode areas 20 on the upper and lower surfaces are used to connect with different electrodes and electrical contacts, respectively. For example, the electrode area 20 on the upper surface of the substrate 10 is used to connect the working electrode 71 with the working electrical contact 81, and the electrode area 20 on the lower surface of the substrate 10 is used to connect the reference electrode 72 with the reference electrical contact 82. In addition, a plurality of mutually isolated electrode units may also be included in one electrode area 20. For example, in one embodiment, the electrode area 20 may include a first electrode unit and a second electrode unit that are isolated from each other. The first electrode unit is used to connect the working electrode 71 with the working electrical contact 81, and the second electrode unit is used to connect the reference electrode 72 with the reference electrical contact 82. In addition, in other embodiments, the electrode area 20 or the electrode unit may also be used as other functional components, such as a counter electrode. That is to say, the electrode area 20 can be printed on different surfaces of the substrate 10 to achieve the connection of different electrodes and different electrical contacts; in addition, after printing the electrode area 20 on the substrate 10, the electrode area 20 can be divided to form multiple independent electrode units to achieve the connection of different electrodes and different electrical contacts; the specific connection method or combination of multiple connection methods can be selected according to actual needs. When the electrode area 20 is printed on both the upper and lower surfaces of the substrate 10, the separation grooves 40 can be opened on both the upper and lower surfaces of the substrate 10, and each of the separation grooves 40 can be filled with an insulating medium.

[0039] At the same time, in one embodiment, a method for manufacturing a continuous analyte sensor is also provided, which comprises the following steps: Please refer to Figure 5 and Figure 6 , printing a conductive layer 201 on the substrate 10; Please refer to Figure 7 , cutting and separating the conductive layer 201 to form separation grooves 40, and separating the conductive layer 201 to form an electrode region 20 located at the inner side and an isolation region 50 located at the edge; Please refer to Figure 8 , printing an insulating medium on the conductive layer 201 to form an insulating layer 30; This step is mainly to cover the areas of the conductive layer 201 that are not involved in connection and reaction with an insulating layer.

[0040] It can be understood that, since the separation grooves 40 have been opened before printing the insulating layer, when printing the insulating layer, the printed insulating medium will flow into and fill the separation grooves 40.

[0041] Please refer to Fig. 9 and Fig.10 , the substrate 10 is cut along the outer contour cutting line 11 to form a single continuous analyte sensor 100, wherein the outer contour cutting line 11 is located outside the separation groove 40. That is, the substrate 10 is cut along the outer contour cutting line 11 to obtain a continuous analyte sensor of a desired size. It can be understood that, since the separation groove 40 has been opened in the previous step and the separation groove 40 is filled with an insulating medium, what is actually cut in this step is the insulating medium or the isolated carbon layer, so that the outer part of the continuous analyte sensor (except the contact point) manufactured in this way will not be short-circuited after contacting water, thereby playing a waterproof role.

[0042] In the manufacturing method of the continuous analyte sensor, an inner cutting line of the outer contour of the continuous analyte sensor process is added to replace the existing direct cutting solution without an inner cutting line (that is, before cutting the substrate 10, the separation groove 40 is first processed on the inner side of the outer contour cutting line 11). Under the condition that the performance of the continuous analyte sensor is not damaged, the introduction of the inner cutting line of the outer contour of the continuous analyte sensor reduces the difficulty of the cutting process, improves the waterproof performance of the continuous analyte sensor, and makes the sensor data more stable and reliable.

[0043] Specifically, in one embodiment, during production, a whole plate can be used for processing, and multiple continuous analyte sensor substrates can be formed on the whole plate, and during the cutting step, the whole plate can be cut into multiple separate continuous analyte sensors, thereby improving production efficiency. During the cutting step, a laser cutting process can be specifically used.

[0044] Specifically, in one embodiment, when printing the conductive layer 201 on the substrate 10 , conductive carbon ink is printed on the surface of the substrate 10 , thereby forming the conductive layer 201 .

[0045] Specifically, in one embodiment, when the conductive layer 20 is cut and separated to form the separation groove 40, the position where the conductive layer 201 connects with the outer contour cutting line 11 on the substrate 10 is offset inward to obtain an inner cutting line of the outer contour, and a cutting device is used to separate the carbon layer of the inner cutting line to form the separation groove 40, so that the carbon wires are all within the outer contour cutting line 11.

[0046] Specifically, in one embodiment, when printing the insulating layer 30 , UV insulating ink is directly printed on the surface of the conductive layer 20 and the substrate 10 .

[0047] Specifically, in one embodiment, after the conductive layer 20 is cut and separated to form the separation groove 40, the following steps are further included: a reference electrode and a detection electrode are respectively provided at the ends of the electrode area 20; More specifically, in one embodiment, after the conductive layer 20 is cut and separated to form the separation groove 40, the following steps are further included: silver chloride printing: printing silver chloride at the front end of the electrode area 20; enzyme application: coating the front end of the electrode area 20 with glucose oxidoreductase. The silver chloride and the glucose oxidoreductase are connected to different units in the electrode area 20 (or connected to different electrode areas 20).

[0048] Preferably, in one embodiment, when the conductive layer 201 is cut and separated, both side edges of the conductive layer 201 are cut and separated, so as to ensure that there is no risk of leakage on both the left and right sides of the electrode area 20.

[0049] Preferably, in one embodiment, the continuous analyte sensor comprises a connection end 101, an implantation end 102, and a middle portion 103 between the connection end 101 and the implantation end 102. When the conductive layer is cut and separated, the conductive layer 201 located in the middle portion 103 is cut along the length direction of the continuous analyte sensor, and the conductive layer 201 located in the connection end 101 and the implantation end 102 is cut along the width direction of the continuous analyte sensor to form the separation groove 40. In this way, the waterproof effect of the portion of the subsequently manufactured continuous analyte sensor exposed between the skin and the bottom surface of the transmitter can be improved, and the processing flow can also be simplified.

[0050] Preferably, in one embodiment, before printing the conductive layer 201 on the substrate 10, the method further includes: opening a hole on the substrate 10 and setting a conductive material in the hole. When printing the conductive layer 201 on the substrate 10, the conductive layer 201 is printed on the upper and lower surfaces of the substrate 10 respectively. When cutting and separating the conductive layer 201, the conductive layer 201 located on the upper and lower surfaces of the substrate 10 is cut and separated respectively. That is, after the conductive layer 201 is divided, the separation grooves 40 are respectively opened on the upper and lower surfaces of the substrate 10. That is, in this embodiment, the conductive layer 201 is printed on both sides of the substrate 10 respectively, and before printing, a hole is opened on the substrate 10 and a conductive material is set, so that the corresponding parts of the conductive layer 201 on both sides can be connected according to needs, so that some units in the conductive layer 201 on both sides can be connected to each other; or the units in the conductive layer 201 can be connected to the electrical contacts (electrodes) through the conductive material in the hole.

[0051] Specifically, in one embodiment, during the step of punching holes in the substrate, the hole may be a complete hole or multiple small holes may be punched in the contact point area. The punching may be performed using process equipment formed in the prior art such as laser punching / laser cutting, CO2 punching / CO2 cutting, etc. After the punching, the substrate 10 is immersed in conductive ink so that the conductive ink fills the hole, thereby electrically connecting the same contact point on the front and back sides, thereby achieving double-sided conduction of the substrate.

[0052] Preferably, in one embodiment, when the conductive layer 201 is cut and separated, the electrode area 20 is also cut and separated, and the electrode area 20 is separated into a plurality of electrode units. This step is mainly to divide the electrode area 20 into a plurality of independent electrode units, so that different electrode units can be connected to different electrodes and electrical contacts. For example, Figure 7 As shown, in one embodiment, an ultraviolet picosecond laser device or laser cutting can be used to divide the electrode area 20 along the length direction to form two parallel electrode units 22. Among them, one electrode unit 22 is used as a connection between the working electrode and the working electrical contact, and the other can be used as a counter electrode (of course, it can also be used as a reference electrode, which can be selected according to needs).

[0053] Preferably, in one embodiment, after the substrate 10 is cut along the contour cutting line 11, the front end of the continuous analyte sensor 100 is coated. Specifically, the end 13 is coated with a biocompatible permeable membrane so that the membrane layer wraps the entire front end portion of the continuous analyte sensor 100.

[0054] Preferably, in one embodiment, before printing the conductive layer 201 on the substrate 10, the process further includes: preheating the substrate 10. By pre-shrinking the substrate 10 by heating, the substrate 10 is not easily deformed during the subsequent printing process. Specifically, in one embodiment, pre-shrinking the substrate 10 is specifically baking the substrate 10 using an ink drying channel. Specifically, the substrate 10 can be made of PET sheet.

[0055] The above description is only an implementation mode of the present invention. It should be pointed out that, for ordinary technicians in this field, improvements can be made without departing from the creative concept of the present invention, but these all belong to the protection scope of the present invention.

Claims

1. A continuous analyte sensor, characterized in that comprising a substrate, an electrode region and an insulating layer; The electrode area is covered on the substrate, and the insulating layer is covered on the electrode area; Wherein, a separation groove is arranged at the edge of the electrode area, and the separation groove is filled with an insulating medium, and the insulating medium isolates the edge of the electrode area from the outside.

2. The continuous analyte sensor according to claim 1, characterized in that It also includes an isolation area, which covers the substrate and is located outside the separation groove. The separation groove isolates the electrode area from the isolation area.

3. The continuous analyte sensor according to claim 1, characterized in that The separation grooves are arranged on both side edges of the electrode area, and each of the separation grooves is filled with the insulating medium.

4. The continuous analyte sensor according to claim 1, characterized in that The continuous analyte sensor includes a connection end, an implantation end, and a middle portion between the connection end and the implantation end; The separation groove is opened at the edge of the electrode area in the middle part, and the insulating medium isolates the electrode area in the middle part from the outside.

5. The continuous analyte sensor according to claim 4, characterized in that Both ends of the separation groove partially extend to the connection end and the implantation end along the length direction of the continuous analyte sensor respectively; And the ends of both ends of the separation groove extend to the edge of the substrate along the width direction of the continuous analyte sensor respectively.

6. A method for manufacturing a continuous analyte sensor, characterized in that: The steps include: printing a conductive layer on a substrate; The conductive layer is cut and separated to form separation grooves; the separation grooves separate the conductive layer into an electrode area located inside and an isolation area located at the edge; printing an insulating medium on the conductive layer; The substrate is cut along a cutting line of the outer contour to form a single continuous analyte sensor, wherein the cutting line of the outer contour is located outside the separation groove.

7. The method for manufacturing a continuous analyte sensor according to claim 6, characterized in that: When the conductive layer is cut and separated, both side edges of the conductive layer are cut and separated.

8. The method for manufacturing a continuous analyte sensor according to claim 6, characterized in that: The continuous analyte sensor includes a connection end, an implantation end, and a middle portion between the connection end and the implantation end; When the conductive layer is cut and separated, the conductive layer located in the middle portion is cut along the length direction of the continuous analyte sensor, and the conductive layer located at the connection end and the implantation end is cut along the width direction of the continuous analyte sensor to form the separation groove.

9. The method for manufacturing a continuous analyte sensor according to claim 6, characterized in that: Before printing the conductive layer on the substrate, the method further includes: opening a hole on the substrate and placing a conductive material in the hole; When printing the conductive layer on the substrate, the conductive layer is printed on the upper and lower surfaces of the substrate respectively; When the conductive layer is cut and separated, the conductive layers located on the upper and lower surfaces of the substrate are cut and separated respectively.

10. The method for manufacturing a continuous analyte sensor according to claim 6, characterized in that: When the conductive layer is cut and separated, the electrode area is also cut and separated, and the electrode area is separated to form a plurality of electrode units.

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