Analyte sensor integrated with temperature detection

Abstract

The utility model discloses a multi-substrate analyte sensor integrated with temperature detection, which comprises at least two layers of substrates, at least two electrodes, pins and a temperature sensor, and the temperature sensor is arranged on the surface of an in-vivo part and is used for directly detecting the in-vivo temperature of a patient, so that the detected temperature does not need to be further calibrated, the temperature treatment process is omitted, and the cost is reduced. The reliability of the detected temperature is improved, the value of the analyte can be directly calibrated according to the detected in-vivo temperature, and the accuracy of analyte detection is improved; meanwhile, the substrate comprises multiple layers of substrates, the electrodes and the temperature sensors can be arranged on different secondary substrates, the electrode or the temperature sensor on each layer of substrate can be set to be larger in area, the electrode or the temperature sensor with the larger area is in more sufficient contact with body fluid, signals are more stable, and the reliability of analyte detection and temperature detection is improved.

Description

TECHNICAL FIELD

[0001] The utility model mainly relates to the field of medical apparatus and instruments, especially to an analyte sensor integrated with temperature detection. BACKGROUND

[0002] The pancreas in a normal human body can automatically monitor the glucose content in the human blood and automatically secrete the required insulin / glucagon. However, the pancreas of a diabetic patient is abnormal and cannot normally secrete the required insulin. Therefore, diabetes is a metabolic disease caused by abnormal function of the human pancreas, and diabetes is a lifelong disease. At present, medical technology cannot cure diabetes, and can only control the occurrence and development of diabetes and its complications by stabilizing blood sugar.

[0003] A diabetic patient needs to detect blood sugar before injecting insulin into the body. Most current detection methods can continuously detect blood sugar and send blood sugar data to a remote device in real time for the user to view. This detection method is called continuous glucose monitoring (CGM) method. The method requires a detection device to be attached to the skin surface, and a probe carried by the detection device to be inserted into subcutaneous tissue fluid to complete the detection. According to the detected blood sugar value, a related algorithm such as a PID algorithm or an MPC algorithm is used to calculate the amount of insulin that needs to be infused into the patient's body. Excessive infusion of insulin can cause the patient to have low blood sugar, and insufficient infusion of insulin can also cause the patient's blood sugar to remain at a high level, causing hyperglycemia. Therefore, the accuracy of the amount of insulin infusion is crucial to maintaining the patient's stable blood sugar, and the amount of insulin infusion is directly related to the detected blood sugar value in the patient's body. Therefore, the accuracy of the blood sugar measurement value is crucial to maintaining the patient's stable blood sugar.

[0004] Because the permeability of the sensor membrane and the activity of the active enzyme are affected by changes in temperature, it is generally believed that temperature also affects the sensitivity of the sensor. The temperature of the sensor when it is shipped or calibrated may be different from the temperature when it is actually used, i.e., when it is in the user's body. Therefore, in order to ensure the accuracy of the blood sugar measurement value, it is necessary to consider the effect of temperature during measurement.

[0005] At present, some temperature sensors are integrated on the transmitter in the prior art for measuring the ambient temperature, and some sensors are integrated on the shell close to the skin for measuring the skin temperature, but none of them is directly measuring the temperature of the sensor in actual use, i.e. the temperature in the body when the sensor is inserted into the body. The temperature measured according to the method in the prior art still needs to be further processed by temperature compensation, algorithm correction and other methods. On the one hand, the processing process is complex, and on the other hand, the processing result is not necessarily accurate and reliable. At the same time, since the area of the sensor substrate is limited, if the temperature sensor is integrated on the substrate, the area of the electrode and the temperature sensor can be designed more limitedly, so that the signal strength and stability of the sensor detection are also affected, and then the reliability of the analyte detection and temperature detection is affected.

[0006] Therefore, the prior art urgently needs an analyte sensor capable of directly detecting the operating temperature of the sensor while improving the accuracy and reliability of blood glucose detection. Practical new type content

[0007] In view of the above shortcomings of the prior art, the embodiments of the present application disclose an analyte sensor integrated with temperature detection, a temperature sensor is arranged on the surface of the in-vivo part of the substrate, which can directly measure the temperature of the analyte sensor during in-vivo detection, without the need for further calibration of the detected temperature, omitting the temperature processing process, improving the reliability of the detected temperature, and according to the detected in-vivo temperature, the analyte value can be directly calibrated, improving the accuracy of analyte detection; at the same time, the substrate includes multiple substrates, and the electrode and the temperature sensor can be arranged on different substrates, the electrode or the temperature sensor on each substrate can be arranged in a larger area, the electrode or the temperature sensor with a larger area is more fully contacted with the body fluid, the signal is more stable, and the reliability of analyte detection and temperature detection is improved.

[0008] The utility model discloses an analyte sensor, which comprises: a substrate including an in-vivo part and an in-vitro part, the substrate including at least two substrates; at least two electrodes arranged on the surface of the in-vivo part for inserting into the subcutaneous tissue to obtain analyte parameter information; a pin arranged on the surface of the in-vitro part and electrically connected to the corresponding electrode through a wire; and a temperature sensor arranged on the surface of the in-vivo part for directly detecting the in-vivo temperature of a patient, wherein the temperature sensor and at least one of the at least two electrodes are arranged on the surface of different substrates.

[0009] According to one aspect of the present application, the temperature sensor and at least one electrode are arranged on the surface of the same substrate.

[0010] According to one aspect of the present application, the temperature sensor and at least one electrode are arranged side by side on the surface of the same substrate.

[0011] According to one aspect of the present application, the temperature sensor and the at least one electrode are sequentially arranged on the same primary substrate surface from the proximal end to the distal end along the in-vivo portion.

[0012] According to one aspect of the present application, the at least two electrodes comprise at least a working electrode and a counter electrode.

[0013] According to one aspect of the present application, the working electrode and the temperature sensor are at the same depth of subcutaneous penetration.

[0014] According to one aspect of the present application, the working electrode and the temperature sensor are arranged side by side on the same primary substrate surface.

[0015] According to one aspect of the present application, the working electrode and the temperature sensor are arranged on different surfaces of different secondary substrates.

[0016] According to one aspect of the present application, the working electrode and the temperature sensor are arranged on different surfaces of adjacent different levels of substrates.

[0017] According to one aspect of the present application, the working electrode and the temperature sensor are arranged on different surfaces of different levels of substrates with intervals.

[0018] According to one aspect of the present application, the at least one layer of substrate comprises multiple levels of substrates, and the working electrode and the temperature sensor are arranged on different surfaces of different levels of substrates.

[0019] According to one aspect of the present application, the at least two levels of substrates are pasted into a whole after being prefabricated.

[0020] According to one aspect of the present application, the temperature sensor is embedded in the working electrode or the counter electrode.

[0021] According to one aspect of the present application, the temperature sensor is one of a metal thin film thermal resistor, a carbon thin film resistor, a metal oxide thin film thermal resistor and an alloy thin film thermal resistor.

[0022] According to one aspect of the present application, the temperature sensor is a thin film platinum thermal resistor.

[0023] According to one aspect of the present application, the temperature sensor comprises a polyimide protective layer.

[0024] According to one aspect of the present application, at least one layer of insulating material is arranged behind at least one area of the substrate surface, and the insulating material avoids the pin area, the electrode and the central conductive area of the temperature sensor.

[0025] According to one aspect of the present application, at least one protective layer is arranged on at least one substrate surface, and the protective layer covers at least the edge of the electrode and / or the temperature sensor.

[0026] According to one aspect of the utility model, the wire is arranged on the surface of the substrate.

[0027] According to one aspect of the utility model, the wire is arranged on the inner layer of the substrate.

[0028] According to one aspect of the utility model, the temperature sensor and the at least two electrodes are arranged on the same surface of the at least two levels of substrates.

[0029] According to one aspect of the utility model, the temperature sensor and the at least one electrode are arranged on different surfaces of the at least two levels of substrates.

[0030] Compared with the prior art, the technical scheme of the utility model has the following advantages:

[0031] The analyte sensor integrated with temperature detection disclosed by the utility model has the temperature sensor arranged on the surface of the inner part of the substrate body, can directly measure the temperature of the analyte sensor when detecting in the body, does not need to further calibrate the detected temperature, omits the temperature processing process, improves the reliability of the detected temperature, can directly calibrate the analyte value according to the detected body temperature, improves the accuracy of analyte detection, and simultaneously, the substrate includes multiple levels of substrates, the electrode and the temperature sensor can be arranged on different secondary substrates, the electrode or the temperature sensor on each level of substrate can be arranged with a larger area, the electrode or the temperature sensor with a larger area is more fully contacted with the body fluid, the signal is more stable, and the analyte detection and temperature detection reliability are improved.

[0032] Further, the at least two electrodes and the temperature sensor are arranged on different levels of secondary substrates, on the one hand, the distance between the electrodes and between the electrodes and the temperature sensor can be increased, signal interference between the electrodes and between the electrodes and the temperature sensor is reduced, and the analyte detection and temperature detection reliability are improved.

[0033] Further, the different levels of secondary substrates can be prefabricated first, that is, the electrode, the wire and the pin are prefabricated on each level of substrate first, then are pasted and combined into a whole, a complete sensor is formed, different from the conventional layer-by-layer coating process, the substrate material solidification insufficiency can be avoided, brittle fracture is caused, insulation failure is caused, further signal interference between the wire or the electrodes appears, noise of the detection signal appears, and the detection reliability of the sensor is improved.

[0034] Further, the temperature sensor and the at least one electrode can be arranged side by side or sequentially on the surface of the inner part, the area of the substrate is fully utilized, and the miniaturization of the analyte sensor is facilitated.

[0035] Further, the temperature sensor and the at least one electrode are arranged on different surfaces of the substrate, the temperature sensor and the electrode can be designed with a larger area, and the reliability of analyte detection and temperature detection is improved.

[0036] Further, the working electrode and the temperature sensor are at the same depth of subcutaneous penetration, and the temperature sensor is in the same operating environment as the working electrode, so the temperature measured by the temperature sensor is the operating temperature of the working electrode, and no further compensation of the measured temperature is needed, so the blood glucose measurement is more accurate.

[0037] Further, the outer layer of the temperature sensor is coated with a liquid polyimide insulating layer as a protective layer, which can reduce or eliminate the stress effects of different material layers, and prevent uneven stress or stress concentration from damaging the temperature sensor.

[0038] Further, at least one layer of insulating material is provided on at least one region of the sensor substrate, and the insulating material avoids the regions where the pins, electrodes and temperature sensor are located, thereby increasing the mechanical strength of the sensor substrate, prolonging the time for the substrate to reach the limit of fatigue when the sensor is bent or folded due to muscle peristalsis after penetrating the skin, thereby prolonging the service life of the sensor and improving the reliability of the sensor in detecting analytes and temperature.

[0039] Further, at least one protective layer is provided on the sensor substrate, and the protective layer covers at least the edges of the electrodes and / or temperature sensor and avoids the central region of the electrodes and / or temperature sensor, thereby preventing the edges of the electrodes and / or temperature sensor from being warped, blistering or falling off, increasing the mechanical strength of the sensor substrate, prolonging the service life of the sensor, and reducing signal noise caused by irregular warping of the edges of the electrodes and / or temperature sensor, thereby improving the reliability of the sensor in detecting analytes and temperature. BRIEF DESCRIPTION OF DRAWINGS

[0040] Figures la-le FIG. 1 is a schematic diagram of an analyte sensor according to an embodiment of the present application, in which the temperature sensor and the electrodes are located on the same surface of the substrate;

[0041] Figures 2a-2k FIG. 2 is a schematic diagram of an analyte sensor according to an embodiment of the present application, in which at least one electrode and the temperature sensor are located on different surfaces of the substrate;

[0042] Figures 3a-3f FIG. 3 is a schematic diagram of an analyte sensor according to an embodiment of the present application, in which an integrated temperature sensor is provided with an insulating material behind at least one region of the sensor substrate;

[0043] Figures 4a-4f FIG. 4 is a schematic diagram of an analyte sensor according to an embodiment of the present application, in which an integrated temperature sensor is provided with a protective layer. DETAILED DESCRIPTION

[0044] As described above, the prior art temperature sensor cannot directly detect the temperature when the electrode is operated, and the detected temperature needs further processing, the processing process is complex, and the processing result is not necessarily accurate and reliable; at the same time, due to the limited area of the sensor substrate, the area of the electrode and the temperature sensor can be designed more limited, so the signal strength and stability of the sensor detection are also affected, and the reliability of the analyte detection and temperature detection is affected.

[0045] In order to solve this problem, the utility model provides analyte sensor of integrated temperature detection, temperature sensor sets up in the surface of the substrate body part, can directly measure the temperature of analyte sensor when in vivo detection, need not to further calibrate the temperature of detection, omit temperature processing process, improve the reliability of the temperature of detection, further according to the in vivo temperature of detection, can directly calibrate analyte value, improve the accuracy of analyte detection, at the same time, the substrate includes multilayer substrate, electrode and temperature sensor can be set on different secondary substrate, can set larger area electrode or temperature sensor on each layer substrate, the electrode or temperature sensor with larger area is more fully contacted with body fluid, the signal is more stable, improve analyte detection and temperature detection reliability.

[0046] Various exemplary embodiments of the present utility model will now be described in detail with reference to the accompanying drawings. It should be understood that the relative arrangement, numerical expressions and values of the components and steps set forth in these embodiments should not be understood as limiting the scope of the present utility model unless otherwise specifically stated.

[0047] In addition, it should be understood that, for the convenience of description, the size of each component shown in the drawings is not necessarily drawn in accordance with the actual proportional relationship, for example, the thickness, width, length or distance of some units can be enlarged relative to other structures.

[0048] The following description of exemplary embodiments is merely illustrative in nature and is in no way intended to limit the present utility model and its application or use in any way. Techniques, methods, and apparatuses known to those of ordinary skill in the relevant art can not be discussed in detail here, but in the case of applicable techniques, methods, and apparatuses, these techniques, methods, and apparatuses should be considered as part of this specification.

[0049] It should be noted that similar reference numbers and letters represent similar items in the following drawings, so once an item is defined or described in one drawing, it does not need to be further discussed in the subsequent drawing description.

[0050] Moreover, it should be understood that the one or more method steps mentioned in the utility model do not exclude that other method steps can exist before and after the combination step or other method steps can be inserted between the explicitly mentioned steps, unless otherwise specified; it should also be understood that the combination connection relationship between the one or more devices / apparatuses mentioned in the utility model does not exclude that other devices / apparatuses can exist before and after the combination device / apparatus or other devices / apparatuses can be inserted between the two explicitly mentioned devices / apparatuses, unless otherwise specified. Moreover, unless otherwise specified, the numbering of each method step is only a convenient tool for identifying each method step, and is not a limitation on the arrangement order of each method step or a limitation on the range of implementation of the utility model, and the change or adjustment of the relative relationship is also regarded as the range of implementation of the utility model without substantial change of technical content.

[0051] Embodiment one

[0052] Figures la-le The schematic diagram of the analyte sensor in which the temperature sensor and the electrode are located on the same surface of the substrate in the embodiment of the utility model.

[0053] Reference Figure la In order to conveniently and clearly show the structural features of the sensor 11, Figure la In the drawings, the length, width, thickness and curve characteristics of the sensor are expressed in an exaggerated form, and the actual length, width, thickness and curve characteristics of the sensor can be different from the drawings.

[0054] In other drawings in the present document, the length, width, thickness and curve characteristics of the sensor are also expressed in an exaggerated form, and the actual length, width, thickness and curve characteristics of the sensor can be different from the drawings, which will not be described below.

[0055] Similarly, the conductive wires, pin electrodes and temperature sensors described in the foregoing and the following are also expressed in an exaggerated form in the drawings, and the conductive wires, pin electrodes and temperature sensors in the drawings are only auxiliary examples for expressing the utility model scheme and are not completely equivalent to the conductive wires, pin electrodes and conductive wires in the actual sensor. For example, the conductive wires in the actual sensor are flat conductive wires with a certain width, and are displayed in the form of lines in the drawings.

[0056] The sensor 11 comprises a substrate 111, so that Figure laThe dashed line is a boundary line, and the base 111 is divided into an extracorporeal part X and an intracorporeal part Y. The intracorporeal part Y is provided with electrodes, including at least one working electrode 1131 (W) and at least one additional electrode. Obviously, in the embodiment, the additional electrode includes a counter electrode 1231 (C) and a reference electrode 1331 (R), thereby forming a three-electrode system. The counter electrode 1231 is another electrode relative to the working electrode 1131, and forms a closed loop with the working electrode 1131, so that the current on the electrode can be normally conducted. The reference electrode 1331 is used to provide a reference potential for the working electrode 1131, and thus the detection potential can be effectively controlled. The extracorporeal part X is provided with pins, and the pins correspond to the electrodes one by one and are electrically connected through wires, that is, the working pin 1111 corresponding to the working electrode 1131 is electrically connected through the wire 1121; the counter pin 1211 corresponding to the counter electrode 1231 is electrically connected through the wire 1221; and the reference pin 1311 corresponding to the reference electrode 1331 is electrically connected through the wire 1321. The wires are arranged on the surface of the base, and the different pins, wires and electrodes are insulated from each other to prevent cross talk of the electrical signals.

[0057] In the embodiment of the utility model, temperature sensor 1431 (T) is also laid on intracorporeal part Y, and is electrically connected with the pin on extracorporeal part X through a wire, and it needs to be explained that two pins are arranged on extracorporeal part X, and are electrically connected with temperature sensor 1431 through two wires laid on intracorporeal part Y, and temperature sensor and its wire and pin are also insulated from other electrodes and their pins and wires. In order to simplify the drawing, only one wire 1421 and one corresponding pin 1411 are shown in the drawing, and only one wire and one corresponding pin are shown in the subsequent other embodiments (except for the outside). Figure le

[0058] In some embodiments of the utility model, the base 111 of the sensor 11 is generally made of flexible material, for example, a combination of one or more selected from polytetrafluoroethylene, polyethylene, polyvinyl chloride, acrylonitrile-butadiene-styrene copolymer, polymethyl methacrylate, polycarbonate and polyimide, which all have good electrical insulation properties, and can insulate the electrodes arranged thereon, the electrodes and the temperature sensor, and the wires from each other. In the preferred embodiment of the utility model, the material of the base 111 is polyimide, which has good adaptability to human physiology and will not cause excessive rejection reaction due to penetration into the subcutaneous tissue.

[0059] ​The temperature sensor 1431 is a thin film thermal resistance, preferably, the temperature sensor 1431 is a thin film platinum thermal resistance, an alumina layer is prepared as an insulating layer on the substrate 111 by a magnetron sputtering process or vacuum evaporation deposition and the like, a platinum film layer is prepared on the alumina layer by a magnetron sputtering process, and a wire is prepared by a magnetron sputtering process, preferably, the wire is a metal alloy, finally, a liquid polyimide insulating layer is coated as a protective layer on the outer layer, so as to reduce or eliminate the stress influence of different material layers, so as to obtain the thin film platinum thermal resistance, wherein the protective layer avoids the central conductive area of the temperature sensor 1431.

[0060] In other embodiments of the present application, the thin film thermal resistance is a metal thin film thermal resistance, a carbon thin film resistance, a metal oxide thin film thermal resistance, and an alloy thin film thermal resistance.

[0061] In the embodiment of the present application, as shown in Figure la The positions of the working electrode 1131 and the temperature sensor 1431 on the substrate 111 are at the same depth of subcutaneous puncture, that is, the temperature sensor 1431 is in the same operating environment as the working electrode 1131, therefore, the temperature measured by the temperature sensor 1431 is the operating temperature of the working electrode 1131, and there is no need to further compensate the measured temperature, so that the blood glucose measurement value is more accurate. Figure la In the embodiment, the positions of the counter electrode 1231 and the reference electrode 1331 on the substrate 111 are also at the same depth of the subcutaneous puncture part, so as to fully utilize the area of the in-vivo part Y, and make the analyte sensor more miniaturized.

[0062] Since the analyte sensor itself is a miniaturized structure, the depth of subcutaneous puncture is in the millimeter level, therefore, even if the temperature sensor 1431 and the working electrode 1131 are not at the same depth of subcutaneous puncture, the depth difference is not large, and they are both at the subcutaneous position, it can also be considered that the temperature sensor 1431 is in the same operating environment as the working electrode 1131, and the temperature measured by the temperature sensor 1431 is the operating temperature of the working electrode 1131, at the same time, it can also be considered that the temperature measured by the temperature sensor 1431 is the temperature in the patient's body, therefore, in other embodiments of the present application, the position arrangement relationship of the working electrode 1131, the counter electrode 1231, the reference electrode 1331 and the temperature sensor 1431 is not limited, for example, the working electrode 1131, the counter electrode 1231, the reference electrode 1331 and the temperature sensor 1431 can be arranged on the substrate in sequence from the proximal end of the in-vivo part to the distal end, it can be understood that the proximal end of the in-vivo part is close to one end of the in-vitro part X, and the distal end of the in-vivo part is away from one end of the in-vitro part X. Figure lbThe temperature sensor 1431 can also be at the same depth position as the counter electrode 1231 or the reference electrode 1331, or other position arrangement relationship, such as the temperature sensor and any two of the four components of the three electrodes are at the same depth, and the other two are at different depths, or any three of the four components are at the same depth, and the other one is at a different depth, etc., as long as the analyte detection and temperature detection are met, and the area of the in-vivo part Y is fully utilized, but preferably, the working electrode 1131 and the temperature sensor 1431 are at the same depth on the substrate 111.

[0063] In Figure la , the lead wire 1121 / 1221 / 1321 / 1421 is laid on the surface of the substrate 111, and in other embodiments of the present application, the lead wire can also be arranged in the inner layer of the substrate, such as Figure lb As shown. When the lead wire 1121 / 1221 / 1321 / 1421 is arranged in the inner layer of the substrate 111, the corresponding position of the lead wire 1121 / 1221 / 1321 / 1421 is connected to the pin, electrode, and temperature sensor arranged on the surface of the substrate 111, and the hole 1141 / 1241 / 1341 / 1441 is arranged on the substrate 111, and the electrically connected end of the lead wire 1121 / 1221 / 1321 / 1421 is led out to the surface of the substrate 111 through the hole 1141 / 1241 / 1341 / 1441, and is electrically connected to the electrode 1131 / 1231 / 1331 and the temperature sensor 1431, respectively. Similarly, the other end of the lead wire 1121 / 1221 / 1321 / 1421 is electrically connected to the pin 1111 / 1211 / 1311 / 1411 through the hole (not shown in the figure). When the lead wire 1121 / 1221 / 1321 / 1421 is arranged in the inner layer of the substrate 111, the substrate 111 can provide insulation protection for each lead wire, avoiding short circuit between the lead wires and causing signal loss or instability, but the processing technology is relatively complex.

[0064] The sensor 11 adopts a three-electrode system, including a working electrode, a counter electrode, and a reference electrode, corresponding working pins, counter pins, and reference pins, and lead wires connecting the pins and electrodes. In other embodiments of the present application, the sensor can also adopt a two-electrode system, which does not include a reference electrode and corresponding pins and lead wires, which is common knowledge in the art and will not be described here.

[0065] As Figure lcAs shown, the substrate 111 is composed of 4 levels of substrates, at least one electrode or temperature sensor can be arranged on each level of substrate 111a / 111b / 111c / 111d, and at least one wire can be arranged in each level of substrate 111a / 111b / 111c / 111d. In other embodiments of the present application, the wire can also be laid on the surface of the substrate, such as Figure la As shown, the electrodes 1131 / 1231 / 1331 and the temperature sensor 1431 are arranged on different levels of substrates 111a / 111b / 111c / 111d respectively. In the first aspect, the distance between the electrodes and between the electrodes and the temperature sensor can be increased, the signal interference between the electrodes and between the electrodes and the temperature sensor can be reduced, and the reliability of the analyte detection and temperature detection can be improved. In the second aspect, the electrodes or the temperature sensor on each level of substrate can be arranged in a larger area, the larger area of the electrodes or the temperature sensor can be more fully contacted with the body fluid, the signal can be more stable, and the reliability of the analyte detection and temperature detection can be improved. In the third aspect, since the electrodes or the temperature sensor are arranged on different levels of substrates, the wires 1121 / 1221 / 1321 / 1421 electrically connected to the electrodes or the temperature sensor can also be laid on different levels of substrates respectively, and therefore the substrates can also electrically insulate the wires 1121 / 1221 / 1321 / 1421. Based on this, the wires 1121 / 1221 / 1321 / 1421 can be laid on the surface of each level of substrate 111a / 111b / 111c / 111d respectively, and the processing technology of the wires is simplified. In the fourth aspect, although the wires 1121 / 1221 / 1321 / 1421 can be laid on the surface of different levels of substrates 111a / 111b / 111c / 111d, once a level of substrate is damaged, the wires of adjacent two levels of substrates can be in contact and short-circuit. Therefore, when the wires 1121 / 1221 / 1321 / 1421 are laid on the substrates 111a / 111b / 111c / 111d, the wires 1121 / 1221 / 1321 / 1421 can be arranged staggered to form a stepped wire distribution. Even if a level of substrate is damaged, the wires of adjacent two levels of substrates will not be in contact and short-circuit, and the reliability of the analyte detection and temperature detection is improved. In the fifth aspect, compared with a single layer of substrate, the substrate composed of multiple levels of substrates has higher mechanical strength and is not easy to be broken or damaged, and the service life of the analyte sensor is prolonged.

[0066] In the embodiments of the utility model, the distribution of the three electrodes 1131 / 1231 / 1331 and the temperature sensor 1431 on each substrate is not fixed, and can be randomly distributed on each level substrate or arranged according to actual requirements, for example, considering that the thickness of the reference electrode 1331 is thicker than that of the working electrode and the counter electrode 1231, the reference electrode 1331 can be arranged on the bottom layer of the substrate 111a to improve the thickness consistency of the sensor 11, so that the sensor 11 does not have an excessively large thickness difference, and the storage and use of the sensor 11 are facilitated. Figure lc In the exaggerated form, the thickness of each layer of the substrate 111a / 111b / 111c / 111d and the electrode 1131 / 1231 / 1331 and the temperature sensor 1431 can be understood as not affecting the description of the scheme.

[0067] In some embodiments of the utility model, each layer of the substrate can be prepared layer by layer, that is, after the bottom layer of the substrate 111a is prepared, the third layer of the substrate 111b is prepared on the basis of the bottom layer of the substrate 111a, and similarly, after the third layer of the substrate 111b is prepared, the second layer of the substrate 111c is prepared, and after the second layer of the substrate 111c is prepared, the top layer of the substrate 111d is prepared. In the usual preparation process, when each layer of the substrate is prepared, the substrate material, for example, polyimide, is heated and coated layer by layer on the mold, and after curing, a complete substrate is formed, but during the curing process, there may be a situation that the material in some areas is not fully cured, or the curing degree of the substrate material on the substrate is inconsistent, or the curing degree of the substrate material on the substrates of different layers is inconsistent, which causes the substrate to be brittle and cracked during subsequent use, which can cause the electrodes, wires and pins arranged on the substrate to be short-circuited with each other or even damaged, affecting the detection reliability of the sensor.

[0068] Based on the existing problem that the base can be brittle failure, in some embodiments of the utility model, the secondary base 111a / 111b / 111c / 111d of each layer can be prefabricated first, here prefabricated refers to that after the base material of each layer of secondary base 111a / 111b / 111c / 111d is fully cured, the electrode / temperature sensor, wire or pin on the base is processed, according to the design requirement of the sensor, the electrode, wire or pin arranged on each layer of secondary base can be same or different. The secondary base 111a / 111b / 111c / 111d of each layer is combined into a whole through the pasting mode after prefabrication, for example, when the material of secondary base 111a / 111b / 111c / 111d is selected as polyimide, the precursor of polyimide can be used to paste each layer of secondary base 111a / 111b / 111c / 111d, and finally the complete sensor base is obtained. Since each layer of secondary base 111a / 111b / 111c / 111d is pasted into a whole after full curing, the brittle problem caused by insufficient curing of the material in the same layer of secondary base can be avoided, and the brittle problem caused by insufficient curing of the material between different layers of secondary base can also be avoided, so that the detection reliability of the sensor is improved. In addition, since each layer of secondary base 111a / 111b / 111c / 111d can be prefabricated independently and then assembled into a whole, the manufacturing efficiency of the sensor can also be improved in the manufacturing link.

[0069] It is worth pointing out that in some embodiments of the utility model, the pins 1111 / 1211 / 1311 / 1411 corresponding to each electrode and temperature sensor 1131 / 1231 / 1331 / 1431 need to be prefabricated on the top layer of secondary base 111d, so that the function of sensor 11 is complete. After the pasting of each layer of secondary base 111a / 111b / 111c / 111d is completed, the wires on the secondary base 111b / 111c / 111d are led to the top layer of secondary base 111a through the punching mode, so as to establish electrical connection with the pins on the secondary base 111a.

[0070] In some embodiments of the utility model, the thickness of each layer of secondary base 111a / 111b / 111c / 111d can be 0.1-100um, which is relatively thin compared with the thickness of the sensor base in the prior art. Figure la And 1bThe thickness of each layer of the base 111a / 111b / 111c / 111d is thinner, otherwise, the thickness of the multiple layers of the base is too thick, and the softness is not enough, which increases the discomfort of the user when the analyte sensor is inserted into the skin of the user. Therefore, preferably, the thickness of each layer of the base 111a / 111b / 111c / 111d is 0.1-20um, and further preferably, the thickness of each layer of the base 111a / 111b / 111c / 111d is about 10um, and the thickness of the whole is about 25-35um. The thickness is not too thin to be easily broken or broken, and the thickness is not too thick to increase the discomfort of the user. Those skilled in the art can understand that due to the error of the processing process, the actual thickness of each layer of the base 111a / 111b / 111c / 111d may deviate.

[0071] In some embodiments of the present application, the material of each layer of the base 111a / 111b / 111c / 111d is preferably polyimide. In order to paste each layer of the base 111a / 111b / 111c / 111d into a whole, the adhesive material can be preferably polyimide precursor. The polyimide precursor can maintain the consistency of the physical properties after curing, and such a pasting method can avoid the peeling or even falling off of each layer of the base 111a / 111b / 111c / 111d due to stress concentration or uneven stress.

[0072] In Figure Id , the base 111 is composed of two layers of bases 111e and 111f. The working electrode 1131 and the temperature sensor 1431 are arranged side by side on the base 111e, and the lead wires 1121 and 1421 are arranged in the inner layer of the base 111e. In other embodiments of the present application, the lead wires can also be laid on the surface of the base, as shown in Figure la . The counter electrode 1231 and the reference electrode 1331 are arranged side by side on the base 111f, and the lead wires 1221 and 1321 are arranged in the inner layer of the base 111f. In other embodiments of the present application, the lead wires can also be laid on the surface of the base, as shown in Figure la . The use of two layers of bases can have the advantages of the multiple layers of bases described in Figure lc , improve the reliability of analyte detection and temperature detection, prolong the service life of the analyte sensor, and at the same time, the working electrode and the temperature sensor are at the same depth of the skin, so that the temperature sensor is in the same operating environment as the working electrode. Therefore, the temperature measured by the temperature sensor is the operating temperature of the working electrode, and further compensation of the measured temperature is not required, so that the blood glucose measurement value is more accurate. Further, the counter electrode and the reference electrode are arranged on the same base, which fully utilizes the area of the inner part Y of the base 111f, and at the same time, the analyte sensor is miniaturized.

[0073] As described above, since the analyte sensor itself is a miniaturized structure, the depth of penetration into the subcutaneous tissue is in the order of millimeters, so even if the temperature sensor and the working electrode are not at the same depth of penetration into the subcutaneous tissue, the difference in depth is not large, and they are both in the subcutaneous position, it can also be considered that the temperature sensor and the working electrode are in the same operating environment, and the temperature measured by the temperature sensor is the operating temperature of the working electrode, so in other embodiments of the present application, the position arrangement relationship of the working electrode, the counter electrode and the reference electrode and the temperature sensor is not limited, for example, the temperature sensor and the reference electrode or the counter electrode are located on the same substrate, and the other two electrodes are located on the same substrate; or only one of the four components of the temperature sensor and the three electrodes is arranged on one substrate, and the other three are arranged on another substrate, and the user can set it according to the actual needs, and the corresponding lead can be arranged on the surface or the inner layer of the corresponding substrate.

[0074] In another embodiment of the present application, the sensor can further include three substrates, and any two of the four components of the three electrodes and the temperature sensor can be arranged on the same substrate, and the other two are separately arranged on the other two substrates, and the four components are arranged on the same surface, such as surface A, of all the substrates, and the corresponding lead can be arranged on the surface or the inner layer of the corresponding substrate.

[0075] Generally, the working electrode and the counter electrode are selected from one of graphite electrodes, glassy carbon electrodes, noble metals and the like, and the reference electrode is selected from one of Ag / AgCl or mercury. Considering the requirements of good ductility and stability of the surface structure, noble metal electrodes such as gold electrodes, platinum electrodes, silver electrodes and the like are preferred, and preferably, the working electrode and the counter electrode are both platinum electrodes. In the embodiment of the present application, the temperature sensor is preferably a thin film platinum thermal resistor, so the temperature sensor can also be embedded in the working electrode or the counter electrode. In addition to realizing the functions of analyte detection and temperature detection, one electrode can also be reduced, and the processing technology is simpler. As shown in the figure, Figure le The temperature sensor 1431 is embedded in the counter electrode 1231, and the temperature sensor 1431 is a thin film platinum thermal resistor strip, one end of which is connected to the temperature sensor special pin through a lead, and the other end is connected to the common pin of the temperature sensor and the counter electrode, so that through the pin of the working electrode, the common pin of the counter electrode and the temperature sensor, and the pin of the reference electrode, the function of analyte detection can be realized, and through the common pin of the temperature sensor and the counter electrode and the temperature sensor special pin, the temperature detection can be realized. In the embodiment of the present application, the resistance strip can increase the length of the resistance strip through reciprocating arrangement, thereby increasing the resistance of the resistance strip, and better realizing analyte detection and temperature detection.

[0076] In other embodiments of the present application, when the sensor is a two-electrode system, i.e., the sensor only includes a working electrode and a counter electrode, one electrode can be further reduced when the temperature sensor can also be embedded in the working electrode or the counter electrode, further simplifying the process. Preferably, the temperature sensor is embedded in the counter electrode.

[0077] Embodiment Two

[0078] Figures 2a-2k An analyte sensor schematic diagram in which at least one electrode and the temperature sensor in the embodiments of the present application are located on different surfaces of the substrate.

[0079] The sensor is a planar structure, therefore, there are two opposite surfaces, i.e., surface A and surface B, when the three electrodes and the temperature sensor are arranged on the surface A and the surface B of the substrate, the surface A and the surface B of the substrate can be fully utilized, the electrodes and the temperature sensor can be arranged in a larger area, the electrodes with a larger area are more fully contacted with the body fluid, the signal is more stable, the analyte detection reliability is improved, the temperature sensor with a larger area is more sensitive in temperature measurement on the one hand, and is more fully contacted with the body fluid on the other hand, the signal is more stable, and the temperature detection reliability is improved. The three electrodes and the temperature sensor can be arranged in any form on the surface A and the surface B of the substrate, such as arranging three components on one surface and arranging one component on the other surface; or arranging two components on each surface, preferably, the working electrode and the temperature sensor are arranged on the two surfaces of the substrate and are at the same depth of subcutaneous puncture, the temperature measured by the temperature sensor is the operating temperature of the working electrode, and it is not necessary to further compensate the measured temperature, so that the blood glucose measurement value is more accurate, such as Figure 2a and 2b As shown, the reference electrode and the counter electrode can be arranged on one surface of the substrate according to actual needs, or can be arranged on the two surfaces of the substrate, and the arrangement mode can be parallel to the working electrode or the temperature sensor (such as Figure la ) or arranged in sequence (such as Figure lb ). The lead can also be arranged on the surface (such as Figure la ) or the inner layer (such as Figure lb ) of the substrate.

[0080] In Figure 2aIn this design, sensor 21 comprises only a substrate 211, a working electrode 2131, a counter electrode 2231, and a reference electrode 2331 disposed on surface A, with corresponding pins also disposed on surface A. Temperature sensor 2431 is disposed on surface B, with corresponding pins also disposed on surface B, and temperature sensor 2431 and working electrode 2131 are inserted at the same depth under the skin. Wires 2121 / 2221 / 2321 / 2421 are laid on the surfaces of surfaces A and B. As mentioned earlier, wires 2121 / 2221 / 2321 / 2421 can also be disposed in the inner layers of surfaces A and B. When both sides of the substrate have substrates, and the sensor is inserted subcutaneously in a bent manner, it needs to be installed in the analyte detection device using a three-dimensional circuit. Specific technical solutions can be found in published patent PCT / CN2022 / 080845.

[0081] When the temperature sensor 2431 is located on one side of the substrate, the three-electrode system and the temperature sensor can be fabricated separately during manufacturing, improving the yield of finished products. At the same time, the analyte detection signal of the three-electrode system and the temperature detection signal of the temperature sensor do not interfere with each other, thereby improving the accuracy of analyte detection and temperature detection.

[0082] exist Figure 2b In this design, sensor 21 comprises only a substrate 211. The working electrode 2131 and reference electrode 2331 are disposed on surface A, with corresponding pins also located on surface A. Temperature sensor 2431 and counter electrode 2231 are disposed on surface B, with corresponding pins also located on surface B. Temperature sensor 2431 and working electrode 2131 are inserted at the same depth under the skin. Wires 2121 / 2221 / 2321 / 2421 are laid on the surfaces of surfaces A and B, and as previously described, wires 2121 / 2221 / 2321 / 2421 are laid in the inner layers of surfaces A and B. The counter electrode 2231 and the temperature sensor 2431 are disposed on the same side of the substrate. On the one hand, the structure of the temperature sensor 2431 embedded in the counter electrode 2231 can be selected to make the area of ​​the temperature sensor 2431 larger, as mentioned above, thereby improving the sensitivity and accuracy of temperature detection. On the other hand, the relative distance between the counter electrode 2231 and the working electrode 2131 can be increased, reducing current crosstalk between the counter electrode 2231 and the working electrode 2131, reducing noise. At the same time, the area of ​​the counter electrode 2231 can be maximized, thereby reducing electrochemical polarization and improving the accuracy and sensitivity of the analyte detection signal.

[0083] In other embodiments of the present application, the reference electrode 2331 and the temperature sensor 2431 can be arranged on the same side of the substrate, in which case, on the one hand, the risk of migration of Ag / Cl substances of the reference electrode 2331 can be reduced, the reliability of the analyte detection can be improved, and on the other hand, when the reference electrode 2331 fails, the three-electrode system becomes a two-electrode system, and the analyte detection stability can be improved.

[0084] Figures 2c-2k The analyte sensor integrated with the temperature sensor comprises a multi-layer substrate, and the advantages of using the multi-layer substrate are as described above.

[0085] In Figures 2c-2f , the sensor comprises two substrates 211a and 211b, and at least one of the three electrodes and the temperature sensor is arranged on different surfaces of the substrates, as shown in Figure 2c and 2d , in Figure 2c , two of the four components, i.e., the temperature sensor 2431 and two electrodes, are arranged on different surfaces of the substrates. In the embodiments of the present application, the arrangement of the four components is not limited, and preferably, the working electrode 2131 and the temperature sensor 2431 are arranged on the same depth of the skin at different surfaces, so that the temperature sensor is in the same operating environment as the working electrode, and thus, the temperature measured by the temperature sensor is the operating temperature of the working electrode, and further compensation of the measured temperature is not needed, so that the blood glucose measurement value is more accurate. As shown in Figure 2c , the reference electrode 2331 and the working electrode 2131 are arranged on the substrate 211a in sequence, and the counter electrode 2231 and the temperature sensor 2431 are arranged on the substrate 211b in sequence. In other embodiments of the present application, the reference electrode 2331 and the working electrode 2131 can be arranged on the substrate 211a in parallel (as shown in Figure la ), the counter electrode 2231 and the temperature sensor 2431 can be arranged on the substrate 211b in parallel (as shown in Figure la ), and the wires 2121 / 2221 / 2321 / 2421 can be laid on the surface or the inner layer of the substrate.

[0086] In Figure 2dIn this embodiment, the temperature sensor 2431 and the reference electrode 2231 are simultaneously disposed on the B side of the sub-substrate 211b, while the working electrode 2131 and the counter electrode 2331 are disposed on the A side of the sub-substrates 211a and 211b, respectively. The wires 2121 / 2221 / 2321 / 2421 can be laid on the surface or inner layer of the sub-substrate. In this embodiment, it is not limited which two of the four components (three electrodes and the temperature sensor) are disposed on one side, nor is it limited how these two components are arranged on the surface of the sub-substrate. Preferably, the working electrode 2131 and the temperature sensor 2431 are disposed on different sides at the same depth under the skin, so that the operating environment of the temperature sensor and the working electrode is the same. Therefore, the temperature measured by the temperature sensor is the operating temperature of the working electrode, eliminating the need for further compensation of the measured temperature and making the blood glucose measurement more accurate.

[0087] exist Figures 2e-2g In this embodiment, the sensor includes two-layer substrates 211a and 211b, and four components: three electrodes and a temperature sensor. One of these components is disposed on one side of a sub-substrate, such as side B, while the other three are disposed on the other side of the sub-substrate, such as side A. Side A of the sub-substrates 211a and 211b is included. In this embodiment, it is not limited which of the four components (three electrodes and a temperature sensor) is disposed on one side, nor is it limited how the other three components are arranged on the other side of the sub-substrates 211a and 211b. Preferably, the working electrode 2131 and the temperature sensor 2431 are disposed on different sides at the same depth of subcutaneous insertion, so that the operating environment of the temperature sensor and the working electrode is the same. Therefore, the temperature measured by the temperature sensor is the operating temperature of the working electrode, and no further compensation is needed for the measured temperature, making the blood glucose measurement value more accurate.

[0088] exist Figure 2e In this design, temperature sensor 2431 is disposed on surface B of sub-substrate 211b, while working electrode 2131, counter electrode 2231, and reference electrode 2331 are disposed on surface A of sub-substrate 211a. Corresponding pins are disposed on the same surface as the electrodes and temperature sensor. Wires can be disposed on the surface or inner layer of the sub-substrate. When temperature sensor 2431 is located on only one side of the substrate, the three-electrode system and temperature sensor can be fabricated separately on sub-substrates 211a and 211b during manufacturing, improving yield. Simultaneously, the analyte detection signal of the three-electrode system and the temperature detection signal of the temperature sensor do not interfere with each other, improving the accuracy of both analyte detection and temperature detection. In this case, the temperature sensor and the three electrodes are disposed on different surfaces of the substrate. When the position of the temperature sensor is interchanged with any of the three electrodes, the temperature sensor and one electrode are disposed on different surfaces of the substrate.

[0089] exist Figure 2fIn this embodiment, the temperature sensor 2431 is disposed on surface B of the sub-substrate 211b, and the working electrode 2131 and the counter electrode 2231 are sequentially arranged on surface A of the sub-substrate 211b. Alternatively, the working electrode 2131 and the counter electrode 2231 can be arranged side-by-side on surface A of the sub-substrate 211b. The reference electrode 2331 is disposed on surface A of the sub-substrate 211a. In other embodiments, the working electrode 2131 and the reference electrode 2331 can be sequentially or side-by-side disposed on surface A of the sub-substrate 211b, while the counter electrode 2231 is disposed solely on surface A of the sub-substrate 211a; alternatively, the working electrode 2131 can be disposed solely on surface A of the sub-substrate 211b, while the counter electrode 2231 and the reference electrode 2331 are sequentially or side-by-side disposed on surface A of the sub-substrate 211a. Figure 2g As shown.

[0090] exist Figures 2h-2j In this embodiment, the sensor includes three layers of substrates 211a, 211b, and 211c. One of the four components—three electrodes and a temperature sensor—is disposed on one side of a sub-substrate, such as side B, while the other three are disposed on the other side of the sub-substrate, such as side A. Side A of the sub-substrates 211a, 211b, and 211c is not limited to which of the four components (electrode and temperature sensor) is disposed on one side, nor is the arrangement of the other three components on the other side of the sub-substrates 211a, 211b, and 211c limited. Preferably, the working electrode 2131 and the temperature sensor 2431 are disposed on different sides at the same depth of subcutaneous insertion, so that the operating environment of the temperature sensor and the working electrode is the same. Therefore, the temperature measured by the temperature sensor is the operating temperature of the working electrode, and no further compensation is needed for the measured temperature, making the blood glucose measurement value more accurate.

[0091] exist Figure 2h In the middle, the temperature sensor 2431 is disposed on the B side of the sub-substrate 211c, and its pins are also disposed on the B side of the sub-substrate 211c. The other three electrodes are disposed on the A side of the three sub-substrates respectively, and their pins are disposed on the A side of the sub-substrate 211a. The wires can be disposed on the surface or inner layer of the sub-substrate.

[0092] exist Figure 2iIn the embodiment, the temperature sensor 2431 is arranged on the B face of the sub-base 211c, and the pin of the temperature sensor 2431 is arranged on the B face of the sub-base 211c; the working electrode 2131 and the counter electrode 2231 are sequentially arranged on the A face of the sub-base 211b, and of course, the working electrode 2131 and the counter electrode 2231 can also be arranged side by side on the A face of the sub-base 211b; the reference electrode is separately arranged on the A face of the sub-base 211a, and the pins of the three electrodes are arranged on the A face of the sub-base 211a; and the wires can be selectively arranged on the surface or the inner layer of the sub-base.

[0093] Figure 2j Compared with the prior art, the working electrode 2131 is arranged on the A face of the sub-base 211a, the reference electrode 2331 and the counter electrode 2231 are arranged on the A face of the sub-base 211b, and the temperature sensor 2431 is arranged on the B face of the sub-base 211c. Figure 2i The working electrode 2131 is arranged on the A face of the sub-base 211a, the reference electrode 2331 and the counter electrode 2231 are arranged on the A face of the sub-base 211b, and the temperature sensor 2431 is arranged on the B face of the sub-base 211c.

[0094] In another embodiment of the utility model, the sensor comprises four layers of sub-bases, one of the four components of three electrodes and a temperature sensor is arranged on one face of one sub-base, and the other three components are arranged on the other face of the other three layers of sub-bases, and in the embodiment of the utility model, the arrangement mode of the four components on the four layers of sub-bases is not limited, preferably, the working electrode 2131 and the temperature sensor 2431 are arranged on different faces and are at the same depth of being inserted into the skin, so that the temperature sensor is in the same operation environment as the working electrode, therefore, the temperature measured by the temperature sensor is the operation temperature of the working electrode, and it is not necessary to further compensate the measured temperature, so that the blood glucose measurement value is more accurate. Figure 2k In the embodiment, the temperature sensor 2431 is arranged on the B face of the sub-base 211d, and the pin of the temperature sensor 2431 is arranged on the B face of the sub-base 211d; the working electrode is arranged on the A face of the sub-base 211c and is at the same depth of being inserted into the skin as the temperature sensor 2431; the reference electrode 2331 and the counter electrode 2231 are respectively arranged on the A faces of the sub-bases 211a and 211b; the pins of the three electrodes are arranged on the A face of the sub-base 211a; and the wires can be selectively arranged on the surface or the inner layer of the sub-base.

[0095] In various embodiments of the present application, the electrodes and temperature sensors can be selectively embedded in the base according to their arrangement on the base.

[0096] Embodiment three

[0097] Figures 3a-3f An analyte sensor with an integrated temperature sensor provided with an insulating material at the rear end is shown in the present application.

[0098] In some embodiments of the present application, after the sensor is inserted into the subcutaneous tissue, in order to adapt to the repeated peristalsis of the muscle, the base is generally flexible, and the flexible base is repeatedly bent or curved during the repeated peristalsis of the muscle, which easily leads to early limit fatigue (without reaching the designed service life of the sensor, for example, 14 days) and breakage or even breakage, which exposes the electrodes, temperature sensors or wires provided on the base and causes short circuit or direct breakage, affecting the reliability of analyte detection and temperature detection of the sensor. In order to improve the reliability of analyte detection and temperature detection of the sensor, the mechanical strength of the base needs to be strengthened to prolong the time of reaching the limit fatigue of the base and meet the designed service life of the sensor.

[0099] In some embodiments of the present application, an insulating material for strengthening the mechanical strength of the base can be provided at the rear end of some areas of the base, and "provided at the rear end" means that after the sensor is processed, that is, after the electrodes, temperature sensors, pins and wires are provided on the base to form a complete sensor, at least one layer of insulating material is provided on the base. Obviously, after the insulating material is added, the mechanical strength of the corresponding area of the base will be improved, and the time of reaching the limit stress fatigue will be prolonged.

[0100] In some embodiments of the present application, the number of layers of insulating material provided at the rear end of the base can be multiple layers, for example, 2 layers, 3 layers or more layers, which can further increase the mechanical strength of the base, but the provision of multiple layers of insulating material will cause the base in the corresponding area to become inflexible, which will increase the discomfort of the user after being inserted into the subcutaneous tissue. Similarly, the thicker the insulating material, the greater the mechanical strength of the base, but the too thick insulating material will also cause the base in the corresponding area to become inflexible, which will increase the discomfort of the user after being inserted into the subcutaneous tissue. Therefore, the number of layers and thickness of the insulating material need to be controlled.

[0101] In the preferred embodiment of the present application, the number of layers of the insulating material is 1-10 layers, and the thickness of each layer is 0.1-100 um.

[0102] In the preferred embodiment of the utility model, the number of layers of the insulating material is one, and the thickness is 25um. In the sensor processing process, setting multiple layers of insulating material will increase the complexity of the processing process. Therefore, setting one layer of insulating material can enhance the mechanical strength of the substrate and will not lead to overly complex processing. The thickness of 25um can keep the substrate soft enough and will not additionally increase the discomfort of the user after the substrate pierces the user's skin.

[0103] In some embodiments of the utility model, the material of the insulating material can be a combination of one or more of polytetrafluoroethylene, polyethylene, polyvinyl chloride, acrylonitrile-butadiene-styrene copolymer, polymethyl methacrylate, polycarbonate, and polyimide. The properties of the above-mentioned materials have been described in the foregoing and will not be repeated here. Preferably, the material of the insulating material is polyimide, which is consistent with the material of the substrate and has the same physical properties. When extension, contraction, bending, or other actions occur, the insulating material and the substrate of the same material have the same extension, contraction, or bending scale, and will not wrinkle, fall off, or experience stress concentration on the substrate due to different scales.

[0104] In some embodiments of the utility model, the insulating material can be set on the substrate by coating. When the material of the insulating material is polyimide, the polyimide can be heated to a liquid state and then coated on the substrate.

[0105] In other embodiments of the utility model, the insulating material can be set on the substrate by pasting. When the material of the insulating material is polyimide, a polyimide precursor can be used as the pasting material. After the polyimide precursor solidifies, its physical properties are basically consistent with those of polyimide, and it has consistency when extending, contracting, or bending. It will not cause bulging, wrinkling, or falling off on the substrate due to stress concentration or uneven stress, thereby improving the yield of the finished sensor.

[0106] In the above process of setting the insulating material on the substrate by coating or pasting, it is necessary to first ensure that the electrodes, temperature sensors, pins, and wires on the substrate are in good electrical connection and that the electrodes, temperature sensors, pins, and wires are well insulated from each other, so that the sensor function can be effectively realized.

[0107] In some embodiments of the utility model, when the insulating material is set on the substrate, it should avoid the areas where the pins, electrodes / temperature sensors are located, otherwise the function of the sensor cannot be realized. Therefore, the area where the insulating material is set at least includes one of the pin back area 312 of the pin area a or the electrode / temperature sensor back area 313 of the electrode / temperature sensor area b. Preferably, both the pin back area 312 and the electrode / temperature sensor back area 313 are provided with insulating material.

[0108] In some other embodiments of this invention, the area where the insulating material is subsequently applied may also include the area near the electrode / temperature sensor and the pin, avoiding the central conductive area of ​​the electrode / temperature sensor and the pin. In this case, the insulating material can cover the edges of the electrode / temperature sensor and the pin, increasing the adhesion between the electrode / temperature sensor and the pin and the substrate, preventing the edges of the electrode / temperature sensor and the pin from warping, and further preventing the electrode / temperature sensor and the pin from breaking or even falling off.

[0109] In some embodiments of this utility model, the pin reverse side region 312 and the electrode / temperature sensor reverse side region 313 can be as follows: Figures 3a-3f In some other embodiments of this invention, the pin reverse area 312 and the electrode / temperature sensor reverse area 313 can be connected to form a continuous area.

[0110] In other embodiments of this invention, the sensor 31 may be installed in the analyte detection device in a bent form, i.e., the external portion X is bent or flexed relative to the internal portion Y, or the internal portion Y is bent or flexed relative to the external portion X. Since the external portion X is fixed inside the analyte detection device, while the external portion Y is inserted subcutaneously and moves with the user's muscle peristalsis, the internal portion Y is also frequently bent or flexed relative to the external portion X. Therefore, it is necessary to provide insulating material behind the bending front area 314 of the bending area c of the internal portion Y relative to the external portion X. Providing insulating material behind the bending front area 314 can, on the one hand, increase the mechanical strength of the substrate in the corresponding area; on the other hand, when the wire is placed on the substrate surface, it can also cover the wire in the corresponding area and provide additional insulation and protection for the wire.

[0111] It should be noted that, in this embodiment of the invention, in order to fully utilize the area of ​​the substrate, the working electrode, reference electrode, counter electrode, and temperature sensor are arranged closely within the body portion Y of the substrate at a safe distance. Therefore, under normal circumstances, the body portion Y does not require subsequent installation of insulating material. However, due to other possible reasons, such as the presence of irregularly shaped electrodes or temperature sensors, a large gap may exist between the three electrodes and the temperature sensor, or between these four components and the edge of the substrate. In such cases, insulating material may be subsequently installed in the gap area to increase the mechanical strength of the corresponding area. Figure 3a and Figure 3e As shown in Figure 315.

[0112] In this embodiment of the invention, depending on the number of sensor layers and the arrangement of electrodes or temperature sensors on the substrate, insulating material can be added later, such as in... Figure 3aIn the embodiment, the sensor comprises a single layer substrate, and the electrodes and the temperature sensor are arranged side by side on the substrate. The pin back surface area 312, the electrode / temperature sensor back surface area 313, the bending front surface area 314 and / or the large interval area 315 on the in-vivo part Y can be provided with insulating material afterwards. Figure 3b In the embodiment, the sensor comprises a single layer substrate, and the electrodes and the temperature sensor are arranged side by side on the substrate. The pin back surface area 312, the electrode / temperature sensor back surface area 313, the bending front surface area 314 and / or the large interval area 315 on the in-vivo part Y can be provided with insulating material afterwards.

[0113] In the embodiment, the sensor comprises a single layer substrate, and the electrodes and the temperature sensor are arranged side by side on the substrate. The pin back surface area 312, the electrode / temperature sensor back surface area 313, the bending front surface area 314 and / or the large interval area 315 on the in-vivo part Y can be provided with insulating material afterwards. Figure 3c In the embodiment, the sensor comprises a single layer substrate, and the electrodes and the temperature sensor are arranged side by side on the substrate. The pin back surface area 312, the electrode / temperature sensor back surface area 313, the bending front surface area 314 and / or the large interval area 315 on the in-vivo part Y can be provided with insulating material afterwards.

[0114] In the embodiment, the sensor comprises a single layer substrate, and the electrodes and the temperature sensor are arranged side by side on the substrate. The pin back surface area 312, the electrode / temperature sensor back surface area 313, the bending front surface area 314 and / or the large interval area 315 on the in-vivo part Y can be provided with insulating material afterwards. Figures 3d-3e In the embodiment, the sensor comprises a single layer substrate, and the electrodes and the temperature sensor are arranged side by side on the substrate. The pin back surface area 312, the electrode / temperature sensor back surface area 313, the bending front surface area 314 and / or the large interval area 315 on the in-vivo part Y can be provided with insulating material afterwards.

[0115] Figure 3f In the embodiment, the sensor comprises a single layer substrate, and the electrodes and the temperature sensor are arranged side by side on the substrate. The pin back surface area 312, the electrode / temperature sensor back surface area 313, the bending front surface area 314 and / or the large interval area 315 on the in-vivo part Y can be provided with insulating material afterwards. In the embodiment, the sensor comprises a single layer substrate, and the electrodes and the temperature sensor are arranged side by side on the substrate. The pin back surface area 312, the electrode / temperature sensor back surface area 313, the bending front surface area 314 and / or the large interval area 315 on the in-vivo part Y can be provided with insulating material afterwards.

[0116] In various embodiments of the present application, the working electrode or the counter electrode can be selectively embedded according to the arrangement of the electrode and the temperature sensor on each substrate.

[0117] Embodiment 4

[0118] Figures 4a-4f The analyte sensor with the integrated temperature sensor provided with the protective layer in the embodiments of the present application.

[0119] In some embodiments of the present application, after the electrode and the temperature sensor, the lead wire and the pin are made on the substrate, a protective layer 416 can be further provided on the substrate. The protective layer 416 can cover the whole substrate, or cover a certain area of the substrate, but expose the central area of the pin, the electrode and the temperature sensor and cover the edges of the pin, the electrode and the temperature sensor. Firstly, the protective layer 416 can enhance the mechanical strength of the substrate and prolong the time of the substrate being damaged. Secondly, the protective layer 416 covers the edges of the pin, the electrode and the temperature sensor, preventing the irregular edges from being exposed to cause signal noise and improving the stability of the detection signal. Thirdly, the electronic conductive layer of the electrode is fixed on the substrate. Since the substrate is repeatedly bent during use, the metal film of the electronic conductive layer is inevitably separated from the substrate to cause edge lifting, bubbling or even falling off. After the protective layer 416 is provided, the protective layer 416 can further enhance the adhesion of the metal film of the electronic conductive layer to the substrate, avoid the edge lifting and bubbling of the metal film, and improve the reliability of the analyte detection of the sensor. The alumina insulation layer of the temperature sensor is also provided on the substrate. Since the substrate is repeatedly bent during use, it is also possible to cause edge lifting, bubbling or even falling off. After the protective layer 416 is provided, the protective layer 416 can further enhance the adhesion of the alumina insulation layer to the substrate, avoid the edge lifting and bubbling of the insulation layer, and improve the reliability of the temperature detection of the sensor.

[0120] In the embodiments of the present application, according to the number of layers of the sensor substrate or the secondary substrate and the arrangement of the electrode or the temperature sensor on the substrate, the protective layer 416 can be correspondingly provided. Specifically, as long as the pin, the electrode or the temperature sensor is provided on one face of a certain layer of the substrate or the secondary substrate, the protective layer 416 can be provided on the face, but the central area of the pin, the electrode and / or the temperature sensor needs to be exposed and the edges of the pin, the electrode and / or the temperature sensor need to be covered.

[0121] As in Figure 4a and 4bIn the embodiment, the sensor comprises a substrate 411, a working electrode 4131, a counter electrode 4231, a reference electrode 4331 and a temperature sensor 4431 arranged side by side or in sequence on the A surface of the substrate 411, thus, the protective layer is arranged only on the A surface of the substrate 411, the center region of the pin, the electrode and the temperature sensor is exposed, and the edge of the pin, the electrode and the temperature sensor is covered at least.

[0122] In the embodiment, Figure 4c In the embodiment, the sensor comprises a substrate 411, a working electrode 4131, a counter electrode 4231, a reference electrode 4331 and a temperature sensor 4431 arranged side by side or in sequence on the A surface of the substrate 411, thus, the protective layer is arranged only on the A surface of the substrate 411, the center region of the pin, the electrode and the temperature sensor is exposed, and the edge of the pin, the electrode and the temperature sensor is covered at least.

[0123] In the embodiment, Figure 4d In the embodiment, 4e In the embodiment, the electrode and the temperature sensor are arranged on different surfaces of the substrate, Figure 4d In the embodiment, 4e In the embodiment, the substrate 411 is a single-layer substrate, and the electrode and / or the temperature sensor are arranged on both surfaces of the substrate 411, thus, the protective layer 416 is arranged on both surfaces of the substrate 411, the center region of the pin, the electrode and / or the temperature sensor is exposed, and the edge of the pin, the electrode and / or the temperature sensor is covered.

[0124] Figure 4f In the embodiment, the sensor comprises a substrate 411, a working electrode 4131, a counter electrode 4231, a reference electrode 4331 and a temperature sensor 4431 arranged side by side or in sequence on the A surface of the substrate 411, thus, the protective layer is arranged only on the A surface of the substrate 411, the center region of the pin, the electrode and the temperature sensor is exposed, and the edge of the pin, the electrode and the temperature sensor is covered at least.

[0125] In some embodiments of the utility model, in order to reduce the manufacturing procedure and difficulty of sensor, save material cost, for the sensor, the electrode and temperature sensor are more precious than pin, and belong to sensitive components, can preferentially consider setting the protective layer 416 to cover the edge of electrode and / or temperature sensor, namely the protective layer 416 does not cover the whole substrate, but covers part of the area of the substrate.

[0126] In some embodiments of the present application, the protective layer 416 has a thickness greater than that of the electrode and the temperature sensor, for example, 1-25um, so that after the protective layer 416 is coated, the position where the electrode and the temperature sensor are located forms a pit, and the structural layers of the electrode, such as the anti-interference layer, the enzyme layer, the adjustment layer and the biocompatible layer, are located in the pit, the pit can accommodate more volume of the anti-interference layer, the enzyme layer, the adjustment layer and the biocompatible layer, and the sensitivity of the electrode is improved. In the preferred embodiments of the present application, the thickness of the protective layer 416 is 1-20um. In the further preferred embodiments of the present application, the thickness of the protective layer 416 is 4um. The protective layer 416 that is too thick will reduce the softness of the substrate, increase the discomfort of the user after piercing into the subcutaneous tissue of the user, and the protective layer 416 that is too thin is easy to be damaged.

[0127] In some embodiments of the present application, the protective layer 416 can have a multi-layer structure, and the overall thickness of the multi-layer protective layer 416 still refers to the thickness described above. When the multi-layer protective layer 416 is provided, the thickness of each layer of the protective layer 416 will become thinner.

[0128] In some embodiments of the present application, the material of the protective layer 416 is one or a combination of polytetrafluoroethylene, polyethylene, polyvinyl chloride, acrylonitrile-butadiene-styrene copolymer, polymethyl methacrylate, polycarbonate and polyimide.

[0129] In some embodiments of the present application, the material of the protective layer 416 is polyimide. After the polyimide is heated appropriately to form a liquid, it is coated on the substrate which is also made of polyimide, and after solidification, the protective layer 416 is formed. The protective layer 416 and the substrate made of the same material have consistent physical properties, which can prevent the protective layer 416 from being damaged or falling off due to uneven stress or stress concentration on the substrate 411.

[0130] In other embodiments of the present application, the insulating material 414 can also be provided after the protective layer 416 is provided, so that the protective layer can prevent the metal film from being curled and blistered while increasing the strength of the substrate 411. The arrangement of the protective layer 416 can refer to the description of the protective layer 416 in the above embodiments. Figures 4a-4e That is, no matter how many layers of substrates the sensor includes, whether the at least one electrode and the temperature sensor are arranged on the same surface or different surfaces of the substrate, whether the electrodes and the temperature sensor are arranged side by side or sequentially on the substrate, as long as the electrode or the temperature sensor is arranged on one surface of one layer of substrate or sub-substrate, the protective layer 416 can be arranged on the surface, but the center area of the pin, the electrode and / or the temperature sensor needs to be exposed and at least cover the edge of the pin, the electrode and / or the temperature sensor. The insulating material 413 is provided on the basis of the protective layer 416, and the arrangement of the insulating material can refer to the description of the insulating material 413 in the above embodiments. Figures 3a-3fThat is, the bending front area 414 of the A face of the uppermost layer and / or the back area 413 of the electrode and / or the temperature sensor of the lowermost layer, and at the same time, if the back area of the pin is not provided with a pin, and there is a larger interval area on the two faces of the substrate, the insulating material can be provided afterwards. Therefore, the way of simultaneously providing a protective layer and an insulating layer on the sensor is Figures 3a-3f In combination with Figures 4a-4e Here, only Figure 4f is exemplified, and other combination modes are within the protection scope of the embodiments of the present application.

[0131] In Figure 4f , the sensor includes four layers of substrates, and the three electrodes and the temperature sensor are respectively arranged on the four layers of substrates, wherein the reference electrode, the counter electrode and the working electrode are respectively arranged on the A faces of the sub-substrates 411d, 411c and 411b, and the temperature sensor is arranged on the B face of the sub-substrate 411a. The working electrode and the temperature sensor are at the same depth of subcutaneous puncture, and the lead wire can be arranged on the surface or the inner layer of the corresponding sub-substrate. The A faces of the sub-substrates 411ab, 411c and 411d are provided with the protective layer 416, but the central areas of the pins and the electrodes are exposed. The B face of the sub-substrate 411a is also provided with the protective layer 416, but the central areas of the pins and the temperature sensor are exposed. The bending front area of the A face of the uppermost layer of the sub-substrate 411a is provided with the insulating material 414, and the back area of the B face of the lowermost layer of the sub-substrate 411d is provided with the insulating material 413.

[0132] In various embodiments of the present application, the counter electrode or the working electrode can be selectively embedded according to the arrangement of the electrodes and the temperature sensor on the substrates.

[0133] In summary, the present application discloses a multi-substrate analyte sensor integrated with temperature detection, the temperature sensor is arranged on the surface of the inner part of the substrate body, which can directly measure the temperature of the analyte sensor during in-vivo detection, without further calibration of the detected temperature, omitting the temperature processing process, improving the reliability of the detected temperature, and directly calibrating the analyte value according to the detected in-vivo temperature, improving the accuracy of analyte detection. At the same time, the substrate includes multiple layers of substrates, and the electrodes and the temperature sensor can be arranged on different sub-substrates, so that the electrodes or the temperature sensor on each layer of substrate can be arranged in a larger area. The larger electrodes or temperature sensors are more fully in contact with the body fluid, the signal is more stable, and the reliability of analyte detection and temperature detection is improved.

[0134] Although some specific embodiments of the present application have been described in detail by way of example with reference to the drawings, it is to be understood that the examples are for illustrative purposes only and are not to be construed as limiting the scope of the present application. It is to be understood that modifications can be made to the above embodiments without departing from the scope and spirit of the present application. The scope of the present application is defined by the appended claims.

Claims

1. An analyte sensor integrated with temperature detection, characterized by, The application relates to a temperature sensor for a sensor patch. The application relates to a temperature sensor for a sensor patch. The application relates to a temperature sensor for a sensor patch. The application relates to a temperature sensor for a sensor patch. The application relates to a temperature sensor for a sensor patch. The application relates to a temperature sensor for a sensor patch.

2. The analyte sensor of claim 1, wherein, The application relates to a temperature sensor for a sensor patch.

3. The analyte sensor of claim 2, wherein, The application relates to a temperature sensor for a sensor patch.

4. The analyte sensor of claim 2, wherein, The application relates to a temperature sensor for a sensor patch.

5. The analyte sensor of claim 2, wherein, The application relates to a temperature sensor for a sensor patch.

6. The analyte sensor of claim 5, wherein, The application relates to a temperature sensor for a sensor patch.

7. The analyte sensor of claim 6, wherein, The application relates to a temperature sensor for a sensor patch.

8. The analyte sensor of claim 6, wherein, The application relates to a temperature sensor for a sensor patch.

9. The analyte sensor of claim 6, wherein, The application relates to a temperature sensor for a sensor patch.

10. The analyte sensor of claim 9, wherein, The application relates to a temperature sensor for a sensor patch.

11. The analyte sensor of claim 9, wherein, The application relates to a temperature sensor for a sensor patch.

12. The analyte sensor of any one of claims 1-11, wherein, The application relates to a temperature sensor for a sensor patch.

13. The analyte sensor of any one of claims 6-11, wherein, The application relates to a temperature sensor for a sensor patch.

14. The analyte sensor of claim 1, wherein, The application relates to a temperature sensor for a sensor patch.

15. The analyte sensor of claim 14, wherein, The application relates to a temperature sensor for a sensor patch.

16. The analyte sensor of claim 15, wherein, The application relates to a temperature sensor for a sensor patch.

17. The analyte sensor of claim 1, wherein, The application relates to a temperature sensor for a sensor patch.

18. The analyte sensor of claim 1, wherein, The application relates to a temperature sensor for a sensor patch.

19. The analyte sensor of claim 1, wherein, The application relates to a temperature sensor for a sensor patch.

20. The analyte sensor of claim 1, wherein, The application relates to a temperature sensor for a sensor patch.

21. The analyte sensor of claim 1, wherein, The application relates to a temperature sensor for a sensor patch.

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