Biosensor and preparation method therefor

Abstract

Provided in the present disclosure are a biosensor and a preparation method therefor. The biosensor comprises a distal portion for measuring a signal related to an analyte level and a proximal portion connected to the distal portion; the biosensor further comprises a base layer, a working electrode provided with a first sensing layer, and a temperature electrode; the working electrode is arranged on the base layer and is formed of a conductive material; the temperature electrode is arranged on the base layer and comprises a sensing portion arranged at the distal portion and a lead portion connected to the sensing portion and partially arranged at the distal portion, the temperature sensitivity of the lead portion being lower than the temperature sensitivity of the sensing portion. Thus, the accuracy of temperature measurement can be improved.

Description

Biosensors and their preparation methods Technical Field

[0001] This disclosure relates to the biopharmaceutical industry, and in particular to a biosensor and its preparation method. Background Technology

[0002] A biosensor is an analytical device that tightly integrates biological materials, bio-derived materials, or biomimetic materials with physicochemical sensors or sensing microsystems that utilize optical, electrochemical, temperature, piezoelectric, magnetic, or micromechanical technologies. Typically, at least a portion of a biosensor can be implanted under the skin to contact bodily fluids and rapidly detect specific analytes in the body, such as glucose and lactic acid.

[0003] Signals acquired by biosensors are generally susceptible to temperature fluctuations; therefore, temperature-related signal processing (e.g., calibration) is necessary. Currently, temperature sensors are typically incorporated into the electronic components applied to the body surface that work in conjunction with biosensors to detect the ambient temperature surrounding the biosensor, such as the temperature within the electronic components themselves.

[0004] However, the ambient temperature mentioned above is only the temperature near the skin surface, not the temperature at the implantation site of the biosensor, and it is easily affected by the surrounding environment. For example, if the user is in a cold environment, the ambient temperature may be lower than the temperature at the implantation site. Even if some existing methods can be used to convert the ambient temperature to the temperature at the implantation site, there will still be an error compared to the actual temperature at the implantation site. This error may lead to errors in the measurement of analytes. Summary of the Invention

[0005] This disclosure is made in view of the above-mentioned circumstances, and its purpose is to provide a biosensor that can improve the accuracy of temperature measurement.

[0006] Therefore, a first aspect of this disclosure provides a biosensor including a distal portion for measuring a signal related to an analyte level and a proximal portion connected to the distal portion. The biosensor further includes a substrate layer, a working electrode having a first sensing layer, and a temperature electrode. The working electrode is disposed on the substrate layer and is formed of a conductive material. The temperature electrode is disposed on the substrate layer and includes a sensing portion disposed on the distal portion and a lead portion connected to the sensing portion and partially disposed on the distal portion. The temperature sensitivity of the lead portion is less than that of the sensing portion. In this configuration, the sensor, including the temperature electrode, can measure the temperature at the sensor implantation site, improving the accuracy of temperature measurement compared to measuring temperatures closer to the skin surface. Furthermore, the sensing portion is disposed on the distal portion, the lead portion is partially disposed on the distal portion, and the temperature sensitivity of the lead portion is less than that of the sensing portion, reducing the impact of temperature changes in the lead portion on the sensing portion and improving the accuracy of temperature measurement.

[0007] Additionally, in the biosensor according to the first aspect of this disclosure, optionally, in the distal portion, the temperature electrode is stacked with the working electrode, and the temperature electrode is attached to the substrate layer. In this case, placing the temperature electrode at the position closest to the substrate layer facilitates reducing the influence of the temperature electrode on the working electrode (e.g., facilitating reducing or completely isolating the temperature electrode from body fluids without affecting the contact between the working electrode and body fluids).

[0008] Furthermore, in the biosensor according to the first aspect of this disclosure, optionally, the sensing element includes a first sensing element disposed on both sides of the substrate layer and a second sensing element connected to the first sensing element. In this case, the space on both sides of the substrate layer can be fully utilized to increase the flexibility of the temperature electrode design, which is beneficial to improving the sensitivity of the temperature electrode.

[0009] Furthermore, in the biosensor disclosed in the first aspect of this invention, optionally, the first sensing element and the second sensing element are made of the same material. In this case, the length and / or area of ​​the sensing element can be further increased, and for a sensor whose physical properties related to temperature changes are correspondingly enhanced by increasing the length and / or area of ​​the sensing element, its sensitivity can be improved.

[0010] Additionally, in the biosensor according to the first aspect of this disclosure, optionally, the temperature electrode further includes a connecting portion for electrically connecting the first sensing part and the second sensing part, the substrate layer having through holes, the connecting portion being disposed in the through holes, and the number of through holes being multiple. In this case, as long as the connection corresponding to one through hole is complete, the two parts of the sensing part can be connected, thereby improving the reliability of the connection.

[0011] Furthermore, in the biosensor according to the first aspect of this disclosure, optionally, the spacing between the multiple through holes is less than a preset distance. In this case, the multiple through holes are more concentrated, which can reduce the impact on other parts of the temperature electrode. For temperature electrodes based on resistance changes, it can also reduce the negative impact of the total resistance decreasing because two through holes connect the resistances of corresponding parts in parallel.

[0012] Furthermore, in the biosensor according to the first aspect of this disclosure, optionally, the sensing portion and the lead portion are located in the same layer relative to the substrate layer and at least partially overlap. This allows for easier splicing of the sensing portion and the lead portion during the fabrication of the temperature electrode, as they are in the same layer. Additionally, the at least partial overlap improves the reliability of the connection between the two.

[0013] Additionally, the biosensor according to the first aspect of this disclosure may optionally include an insulating layer that completely covers the sensing element. This isolates it from the analyte measuring electrode to avoid mutual interference.

[0014] Furthermore, in the biosensor according to the first aspect of this disclosure, optionally, the temperature electrode is provided with a second sensing layer and configured to switch between a first state and a second state. When the temperature electrode is in the first state, a first circuit for measuring temperature is activated; when the temperature electrode is in the second state, a second circuit for measuring the analyte corresponding to the second sensing layer is activated. Thus, both temperature measurement and analyte measurement can be achieved using the temperature electrode.

[0015] Furthermore, in the biosensor according to the first aspect of this disclosure, optionally, the first applied voltage of the first circuit is greater than the second applied voltage of the second circuit. In this case, the voltage applied to the circuit measuring the analyte is smaller, and the current change corresponding to the resistance change of the portion of the temperature electrode that serves as a wire is smaller and can be ignored compared to the current corresponding to the sensor signal (that is, the effect on the second circuit is essentially negligible).

[0016] A second aspect of this disclosure provides a method for fabricating a biosensor, the biosensor including a distal portion for measuring a signal related to an analyte level and a proximal portion connected to the distal portion. The fabrication method includes forming a working electrode on a substrate layer using a conductive material, disposing a first sensing layer on the working electrode, and forming a temperature electrode on the substrate layer. The temperature electrode includes a sensing portion disposed on the distal portion and a lead portion connected to and partially disposed on the distal portion. The sensing portion is made of a first material, and the lead portion is made of a second material, the second material having a lower temperature sensitivity than the first material. This improves the accuracy of temperature measurement.

[0017] According to this disclosure, a biosensor capable of improving the accuracy of temperature measurement is provided. Attached Figure Description

[0018] This disclosure will now be explained in further detail by way of example only with reference to the accompanying drawings.

[0019] Figure 1 is a schematic diagram illustrating the glucose concentration monitoring environment involved in the example of this disclosure.

[0020] Figure 2 is a schematic diagram illustrating the structure of the sensor involved in the example of this disclosure.

[0021] Figure 3 is a schematic diagram illustrating the structure of a sensor involving electrodes according to an example of this disclosure.

[0022] Figure 4 is a schematic diagram illustrating the structure of the via and temperature electrode in this disclosure example.

[0023] Figure 5 is a schematic diagram of the structure of a sensor with a second sensing layer provided on the temperature electrode according to an example of this disclosure.

[0024] Figure 6 is a schematic diagram illustrating that the temperature electrode involved in the example of this disclosure can switch between a first state and a second state.

[0025] Figure 7A is a schematic diagram illustrating the implementation of multiple working electrodes in a parallel manner on the insulating layer of a temperature electrode, as described in the example of this disclosure.

[0026] Figure 7B is a schematic diagram illustrating the implementation of multiple working electrodes on the insulating layer of a temperature electrode in a stacked manner, as described in the example of this disclosure.

[0027] Figure 8 is an exemplary flowchart illustrating the preparation method involved in the example of this disclosure.

[0028] Figure 9A is an exemplary flowchart illustrating the fabrication of the sensor shown in Figure 3 as described in this disclosure.

[0029] Figure 9B is a schematic diagram illustrating the fabrication of the sensor shown in Figure 3 according to an example of this disclosure. Detailed Implementation

[0030] Hereinafter, preferred embodiments of the present disclosure will be described in detail with reference to the accompanying drawings. In the following description, the same reference numerals are used for the same components, and repeated descriptions are omitted. Furthermore, the drawings are merely schematic diagrams, and the proportions of the components or the shapes of the components may differ from actual figures. It should be noted that the terms "comprising" and "having," and any variations thereof, in this disclosure, do not necessarily limit the process, method, system, product, or apparatus to the explicitly listed steps or units, but may include or have other steps or units not explicitly listed or inherent to these processes, methods, products, or apparatuses.

[0031] First, let me introduce the relevant terminology used in this disclosure.

[0032] "Temperature-sensitive materials" can refer to materials that can generate a change in electrical signal in response to changes in external temperature (i.e., materials affected by temperature). For example, temperature-sensitive materials can include thermocouples, metallic resistors, and thermistors. Additionally, temperature-sensitive materials can also be called temperature-sensitive materials.

[0033] "Temperature sensitivity" refers to a substance's ability to respond to temperature changes. When temperature changes, a substance's physical or chemical properties may alter, allowing us to infer the current temperature by measuring these properties (e.g., electrical resistance). For example, temperature-sensitive materials exhibit changes in their physical or chemical properties with temperature variations. Furthermore, the more significant the change in properties, the greater the substance's temperature sensitivity. Higher temperature sensitivity indicates a greater change in physical or chemical properties with temperature. Conversely, zero temperature sensitivity indicates that the physical or chemical properties do not change with temperature.

[0034] This disclosure relates to a biosensor for monitoring analytes. The biosensor can acquire a signal related to the analyte level (hereinafter referred to as a sensor signal), and includes a temperature electrode capable of measuring the temperature at the sensor implantation site to obtain a more accurate temperature (i.e., the temperature measured by the temperature electrode being deeply embedded in the implantation site is more accurate). This improves the accuracy of analyte measurement when the temperature measured by the sensor is applied to processing (e.g., calibrating) the sensor signal or analyte level. Additionally, it can monitor the body temperature of the host with the implanted sensor. For example, it can provide a high fever warning for a person with a fever or a low fever warning for an outdoor enthusiast.

[0035] Hereinafter, biosensors will be referred to simply as sensors. The sensors described in this disclosure may also be called monitoring probes, sensing probes, or electrode probes, etc.

[0036] In some examples, for an analyte of glucose, the sensor can be a glucose sensor, and the analyte level can be glucose concentration. However, it is not limited to glucose concentration. For example, by changing the sensing layer of the sensor, other body fluid components besides glucose concentration can also be obtained. These body fluid components can be, for example, one or more of the following: glucose, acetylcholine, amylase, bilirubin, cholesterol, human chorionic gonadotropin, creatine kinase, creatine, creatine anhydride, DNA, fructosamine, glutamine, growth hormone, hormones, blood ketones, lactate, oxygen, peroxides, prostate-specific antigen, prothrombin, RNA, thyroid-stimulating hormone, or troponin.

[0037] For ease of description, some examples below use glucose as the analyte, with the analyte level being glucose concentration, and the temperature electrode being a resistance-based temperature electrode. It should be noted that this does not constitute a limitation of this disclosure, and unless contradictory, the descriptions apply equally to other analyte levels and other temperature electrodes.

[0038] The following description, in conjunction with the accompanying drawings, will provide a detailed account of an example of this disclosure. Figure 1 is a schematic diagram illustrating the glucose concentration monitoring environment involved in an example of this disclosure.

[0039] Referring to Figure 1, the monitoring environment may include a control device 100 and a receiving device 900. The control device 100 may be configured to acquire analyte information of the host. The receiving device 900 may be configured to receive the analyte information and process and / or display the analyte information.

[0040] In some examples, control device 100 may be coupled to receiving device 900. Control device 100 may be configured to send analyte information to receiving device 900. In some examples, control device 100 may be directly or indirectly communicatively coupled to receiving device 900. Control device 100 may be communicatively coupled to receiving device 900 via one or more communication links. For example, communication links may include at least one of proprietary wireless protocols, wired communication links (e.g., serial communication), and wireless communication links (e.g., Bluetooth). In other examples, control device 100 may also operate as a standalone device with receiving device 900 integrated within it.

[0041] Referring again to Figure 1, the control device 100 may include a sensor 1 and an electronic component 2. The sensor 1 can be used to measure sensor signals, and the electronic component 2 can be used to receive sensor signals.

[0042] In some examples, at least a portion of sensor 1 may be implanted under the skin of the host, electronic component 2 may be adhered to the surface of the host's body, and at least a portion of sensor 1 may be electrically connected to electronic component 2.

[0043] Figure 2 is a schematic diagram illustrating the structure of sensor 1 as described in this disclosure. It should be noted that Figure 2 is for illustrating the general structure of sensor 1 and does not show all the details of sensor 1, nor does it imply any limitation on this disclosure.

[0044] Referring to Figure 2, in some examples, sensor 1 may include a distal portion 11 and a proximal portion 12. The distal portion 11 may be used to measure sensor signals. The proximal portion 12 may be used to receive sensor signals. Additionally, the proximal portion 12 may be connected to the distal portion 11.

[0045] In some examples, the proximal portion 12 may be electrically connected to the distal portion 11. In some examples, the distal portion 11 may be electrically connected to the electronic component 2 via the proximal portion 12 to transmit sensor signals to the electronic component 2. In some examples, the proximal portion 12 may be provided with multiple contacts that can be used for connection to the electronic component 2.

[0046] In some examples, the distal portion 11 may be placed subcutaneously in the host. In some examples, the proximal portion 12 may be located on the electronic component 2.

[0047] Figure 3 is a schematic diagram illustrating the structure of sensor 1 with electrodes according to an example of this disclosure. It should be noted that the electrodes shown in Figure 3 are stacked; however, this does not imply a limitation of this disclosure. For example, some or all of these electrodes may also be stacked or arranged side by side.

[0048] Referring to Figure 3, in some examples, sensor 1 may include a substrate layer 13. The substrate layer 13 may be used to mount electrodes and / or an insulating layer 18. The electrodes may be used to perform corresponding functions (e.g., measuring analytes or temperature).

[0049] In some examples, the substrate 13 may be a flexible substrate. In some examples, the flexible substrate may be made of at least one of polyethylene (PE), polypropylene (PP), polyimide (PI), polystyrene (PS), polyethylene terephthalate (PET), and polyethylene terephthalate (PEN). In some examples, the flexible substrate may also be made of metal foil, ultrathin glass, single-layer inorganic film, multilayer organic film, or multilayer inorganic film.

[0050] In some examples, the substrate 13 may also be a non-flexible substrate. A non-flexible substrate may include ceramics, alumina, or silicon dioxide, which have low conductivity.

[0051] In some examples, the substrate 13 may have a front side and a back side opposite to the front side. Hereinafter referred to as the two sides of the substrate 13.

[0052] Figure 4 is a schematic diagram showing the structure of the via 131 and temperature electrode 17 in this disclosure example.

[0053] Referring to Figures 3 and 4, in some examples, the substrate 13 may have a through-hole 131. The two parts of the sensing portion 171 of the temperature electrode 17 (described later) can be connected through the through-hole 131. In some examples, the connection portion 1713 of the temperature electrode 17 may be provided in the through-hole 131.

[0054] In some examples, the number of through holes 131 can be one or more. Preferably, the number of through holes 131 can be multiple. In this case, as long as the connection corresponding to one through hole 131 is complete, the two parts of the sensing unit 171 can be connected, which can improve the reliability of the connection. For example, the number of through holes 131 can be two or three, etc. As an example, Figure 4 shows an example with three through holes 131.

[0055] In some examples, for the temperature electrode 17 based on resistance change, the temperature electrode 17 can be arranged in parallel in multiple portions corresponding to multiple through holes 131.

[0056] Referring to FIG3, in some examples, the via 131 may be provided on the side of the substrate 13 closer to the sensing layer (e.g., the first sensing layer 141 and the second sensing layer 173 described later). In this case, when connecting the two parts of the sensing portion 171, it is convenient to bring the sensing portion 171 closer to the sensing layer as a whole, and to obtain a temperature closer to the sensing layer. In some examples, the via 131 may be provided at the end of the temperature electrode 17 (refer to FIG4).

[0057] Referring to Figure 4, in some examples, multiple vias 131 can be distributed along the trajectory of the temperature electrode 17. In some examples, the spacing between the multiple vias 131 can be less than a preset distance. In this case, the multiple vias 131 are more concentrated, which can reduce the impact on other parts of the temperature electrode 17. For the temperature electrode 17 based on resistance change, it can also reduce the negative impact of the total resistance decreasing because two vias 131 connect the resistances of corresponding parts in parallel. In addition, the spacing distance can refer to the length of the temperature electrode 17 between two vias 131 (refer to Figure 4). Furthermore, the preset distance can be set as needed, so as not to affect the measured temperature or to have a negligible impact.

[0058] In some examples, sensor 1 may include multiple electrodes. These electrodes may be disposed on substrate 13. In some examples, the multiple electrodes may include at least one of a working electrode 14, a temperature electrode 17, a counter electrode 15, and a reference electrode 16. At least one of the multiple electrodes may be selected to perform the desired function, and the various electrodes will be described later.

[0059] In some examples, sensor 1 may include a working electrode 14. This enables monitoring of the corresponding analyte. In some examples, sensor 1 may include a working electrode 14, a counter electrode 15, and a reference electrode 16. This allows the formation of a sensor 1 with a three-electrode system. In some examples, sensor 1 may include a temperature electrode 17. This enables monitoring of the temperature at the implantation site.

[0060] In some examples, there may be multiple electrodes in sensor 1. In some examples, the multiple electrodes may be arranged side-by-side or stacked. In some examples, the multiple electrodes may be arranged side-by-side or stacked on temperature electrode 17. In some examples, the electrodes related to analyte measurement among the multiple electrodes may be arranged side-by-side or stacked on temperature electrode 17.

[0061] Referring to Figure 3, in some examples, some or all of the multiple electrodes may be layered and disposed on different sides of the substrate 13. In some examples, some or all of the multiple electrodes may also be disposed at staggered depths and / or coplanarly on the same side of the substrate 13.

[0062] In some examples, electrodes can be formed by coating the substrate 13 with a conductive material (e.g., conductive paste) using various processes. For example, processes can include screen printing, inkjet printing, vacuum magnetron sputtering, evaporation, or plating. In some examples, the working electrode 14 can be formed on the substrate 13 using a conductive material, as can the counter electrode 15 and / or the reference electrode 16, and the temperature electrode 17.

[0063] In some examples, the conductive material may include at least one of carbon paste, copper paste, and silver paste. In some examples, the material of the sensing portion 171 of the temperature electrode 17 may be a conductive material incorporating a thermosensitive material.

[0064] Alternatively, the electrode can be formed directly on the substrate layer 13, or it can be formed on the layer corresponding to other electrodes. When using the insulating layer 18 to isolate the electrode, the electrode can also be formed on the insulating layer 18 of other electrodes.

[0065] Additionally, the working electrode 14 can be used to generate a sensor signal. As described above, the sensor signal can be, for example, a signal corresponding to blood ketones, lactic acid, or glucose, but the examples in this disclosure are not limited to these.

[0066] For ease of description, the analyte monitored by the working electrode 14 will be referred to as the first analyte. It should be noted that, depending on the number of working electrodes 14 and the material of the first sensing layer 141, the first analyte can be one or more analytes.

[0067] Referring to Figure 3, in some examples, the working electrode 14 may be provided with a first sensing layer 141. The first sensing layer 141 can be used to generate a sensor signal. This enables the measurement of the analyte. In some examples, the working electrode 14 may also not have a sensing layer. This enables the measurement of background signals other than the sensing signal.

[0068] In some examples, the sensing layer can be used to participate in the reaction of the analyte to generate a sensor signal. In some examples, the sensing layer may include an enzyme that contacts the analyte and promotes a redox reaction to generate a sensor signal.

[0069] In some examples, for a glucose sensor, the first sensing layer 141 may include a glucose enzyme. The distal portion 11, placed subcutaneously, can promote a redox reaction of glucose in bodily fluids via the glucose enzyme on the working electrode 14 to generate an electrical signal (i.e., one type of sensor signal). In some examples, processing the electrical signal can yield glucose concentration information.

[0070] Referring to Figure 3, in some examples, the first sensing layer 141 may be disposed on the side of the working electrode 14 away from the proximal portion 12. In other words, the first sensing layer 141 may be disposed on the side of the working electrode 14 located at the distal portion 11. This facilitates contact between the first sensing layer 141 and bodily fluids.

[0071] In some examples, the working electrode 14 can form a loop with the counter electrode 15 (described later) to generate a sensor signal.

[0072] In some examples, there can be multiple working electrodes 14. This facilitates the measurement of different analytes or the acquisition of multiple measurement results for the same analyte. As an example, Figure 3 shows two working electrodes 14.

[0073] In some examples, the working electrode 14 may be disposed on the substrate layer 13. In some examples, the working electrode 14 may be a conductive layer formed on the substrate layer 13. In some examples, for multiple working electrodes 14, they may be uniformly distributed on both sides of the substrate layer 13. As an example, Figure 3 shows two working electrodes 14 located on both sides of the substrate layer 13, respectively.

[0074] In some examples, the working electrode 14 can be formed of a conductive material. This allows for the transmission of electrical signals.

[0075] As described above, in some examples, sensor 1 may include counter electrode 15 (refer to FIG. 3). Counter electrode 15 may form a circuit with working electrode 14 to generate a sensor signal.

[0076] As described above, in some examples, sensor 1 may include a reference electrode 16 (refer to FIG. 3), which can be used to form a potential difference with working electrode 14. In some examples, reference electrode 16 can form a known and fixed potential difference with body fluid. In this case, by measuring the potential difference between working electrode 14 and body fluid through the potential difference formed by reference electrode 16 and working electrode 14, the voltage generated by working electrode 14 can be obtained more accurately.

[0077] Referring to Figure 3, in some examples, the reference electrode 16 may be provided with a potential stabilizing layer 161. The potential stabilizing layer 161 can be used to stabilize the potential. In some examples, the material of the potential stabilizing layer 161 may be silver / silver chloride.

[0078] As described above, the working electrode 14 can be disposed on the substrate layer 13. In some examples, the counter electrode 15 and the reference electrode 16 can also be disposed on the substrate layer 13. Referring to FIG3, in some examples, the working electrode 14, the counter electrode 15, and the reference electrode 16 can be distributed on both sides of the substrate layer 13. In other examples, the working electrode 14, the counter electrode 15, and the reference electrode 16 can be distributed on the same side of the substrate layer 13.

[0079] In some examples, sensor 1 may not include working electrode 14. For example, if temperature electrode 17 is provided with a second sensing layer 173, temperature electrode 17 can also serve as an electrode for measuring analytes.

[0080] As described above, in some examples, sensor 1 may include a temperature electrode 17. Referring to FIG3, in some examples, temperature electrode 17 may include a sensing element 171. The sensing element 171 may be configured to measure temperature.

[0081] In some examples, the temperature electrode 17 may also include a lead portion 172. The lead portion 172 may be connected to the sensing unit 171 and may be configured to receive the measured temperature. In some examples, the lead portion 172 may be connected to the electronic component 2 to transmit the received temperature.

[0082] Referring to Figure 3, in some examples, the sensing element 171 may be disposed in the distal portion 11, and the lead portion 172 may be connected to the sensing element 171, and the lead portion 172 may be partially disposed in the distal portion 11. In this case, it is convenient to design the sensing element 171 and the lead portion 172 separately to reduce the influence of temperature changes of the lead portion 172 on the sensing element 171 and improve the accuracy of temperature measurement.

[0083] In some examples, the temperature sensitivity of the lead portion 172 may be less than that of the sensing portion 171. That is, the properties of the sensing portion 171 change more significantly with temperature variations than those of the lead portion 172. Therefore, the influence of temperature changes in the lead portion 172 on the sensing portion 171 can be reduced, thereby improving the accuracy of temperature measurement.

[0084] Specifically, the properties (e.g., resistance) of the sensing element 171 change with temperature. The lead 172 is generally connected to the electronic component 2, and the temperature within the electronic component 2 is easily affected by the surrounding environment. If the temperature sensitivity of the lead 172 and the sensing element 171 is the same (e.g., the lead 172 and the sensing element 171 are made of the same material and are integrally formed) or the temperature sensitivity of the lead 172 is higher than that of the sensing element 171, then the lead 172 will sense the temperature of the surrounding environment, thereby affecting the overall properties of the temperature electrode 17 and thus affecting the measured temperature. For example, for the sensor 1 implanted under the host's skin, the temperature sensitivity of the lead 172 is lower than that of the sensing element 171, which can reduce the interference of surface temperature fluctuations on subcutaneous temperature measurement.

[0085] In some examples, the temperature electrode 17 can be formed by connecting at least two materials. In this case, it is convenient to design the temperature sensitivity of the distal portion 11 and the proximal portion 12 separately to reduce the effect of temperature changes in the proximal portion 12 on the sensing portion 171.

[0086] In some examples, the sensing element 171 may be made of a first material. In some examples, the lead element 172 may be made of a second material. In some examples, the temperature sensitivity of the second material may be less than that of the first material.

[0087] In some examples, the temperature sensitivity of the first material can be greater than 0. That is, the first material can be a temperature-sensitive material (i.e., a thermosensitive material). In some examples, the temperature sensitivity of the second material can be 0 (i.e., a non-thermosensitive material). This avoids the influence of temperature changes in the lead portion 172 on the sensing portion 171. For example, referring to FIG3, the sensing portion 171 can be a thermosensitive material, and the lead portion 172 can be a non-thermosensitive material. For the sensor 1 implanted under the host's skin, the subcutaneous portion of the sensor 1 can be a wire made of a thermosensitive material, while the supracutaneous portion can be a normal wire without thermosensitive characteristics, preventing external temperature fluctuations from interfering with stable subcutaneous measurements.

[0088] In addition, specific first and second materials can be selected according to the accuracy requirements of the measured temperature, and this disclosure does not impose any particular limitations on this.

[0089] In some examples, the first material can be a conductive material with added temperature-sensitive material. In some examples, the first material can be made by adding a temperature-sensitive material to a second material. In this case, the first and second materials share a common material, which facilitates the fabrication of the sensing part 171 and the lead part 172 using the same process, thereby facilitating the connection of the sensing part 171 and the lead part 172 and simplifying the process. For example, for the temperature electrode 17 based on resistance change, the second material can be carbon paste, and the first material can be carbon paste with added temperature-sensitive material.

[0090] In other examples, the first material and the second material can also be the same. For example, the shape of the sensing part 171 can be changed so that the sensing part 171 and the lead part 172 are affected differently by temperature.

[0091] Referring to Figure 3, in some examples, the sensing portion 171 and the lead portion 172 can be located in the same layer relative to the substrate layer 13. That is, the sensing portion 171 and the lead portion 172 can be located on the same plane, and this plane is located on the substrate layer 13. This facilitates the splicing of the sensing portion 171 and the lead portion 172 when fabricating the temperature electrode 17.

[0092] Referring to Figure 4, in some examples, the sensing part 171 and the lead part 172 may at least partially overlap. This improves the reliability of their connection.

[0093] In some examples, at the connection between the sensing part 171 and the lead part 172, the width of the sensing part 171 may be greater than the width of the sensing part 171 at other locations. In this case, the contact area between the sensing part 171 and the lead part 172 at the connection is larger, which can improve the reliability of the connection.

[0094] In some examples, sensing elements 171 and lead elements 172 with different temperature sensitivities can be spliced ​​together. In this case, the splicing design facilitates the retention of the temperature-sensitive sensing element 171 at the implantation site and the connection to external devices (e.g., electronic components 2) via the temperature-sensitive or zero-sensitive lead elements 172. For example, for a sensor 1 implanted under the host's skin, the sensing element 171 of the temperature electrode 17 is fabricated at the tip (i.e., part of the distal portion 11) of the implantable sensor 1 by splicing. After the sensor 1 is implanted, the sensing element 171 detects changes in body temperature and is less affected by external interference.

[0095] As an example, Figure 4 shows an example of electrical connection achieved after the sensing part 171 and the lead part 172 are spliced ​​and printed. In this example, the sensing part 171 can be located at the distal portion 11, a small portion of the lead part 172 can be located at the distal portion 11 to facilitate connection with the sensing part 171, and the majority of the lead part 172 can be located at the proximal portion 12 to facilitate connection with the electronic component 2.

[0096] In some examples, on the same layer relative to the substrate layer 13, a layer corresponding to one of the elements, the sensing portion 171 and the lead portion 172, can be formed first, followed by a layer corresponding to the other element. Preferably, the process of splicing the sensing portion 171 and the lead portion 172 can be screen printing. This facilitates the formation of different elements on the same layer and simplifies the process of splicing the sensing portion 171 and the lead portion 172. In some examples, the sensing portion 171 and the lead portion 172 can be wires made of different materials formed on the substrate layer 13.

[0097] In some examples, the sensing element 171 may be configured with increased length and / or area. The configuration of the sensing element 171 is specifically related to the method by which the temperature electrode 17 measures temperature.

[0098] Referring to Figure 4, in some examples, at least a portion of the sensing element 171 can be arranged in a continuous and bent-extending shape. In this case, the length of the sensing element 171 can be further increased within a limited space. For the temperature electrode 17 based on resistance changes, the resistance of the temperature electrode 17 can also be increased, thereby improving sensitivity. Specifically, if the resistance is greater, the resistance change is greater relative to the same temperature change, and the probability of the resistance value being detected is greater. In addition, when the temperature electrode 17 is arranged in conjunction with the substrate layer 13, the surface of the substrate layer 13 can be fully utilized to increase the length of the sensing element 171. As an example, Figure 4 shows an example where a portion of the sensing element 171 extends in a repeating bent pattern.

[0099] Referring back to Figure 3, in some examples, the sensing element 171 may include a first sensing element 1711 and a second sensing element 1712 respectively disposed on both sides of the substrate layer 13. Both the first sensing element 1711 and the second sensing element 1712 may be made of a temperature-sensitive material. In this case, the space on both sides of the substrate layer 13 can be fully utilized to increase the design flexibility of the temperature electrode 17, which is beneficial for improving the sensitivity of the temperature electrode 17. Furthermore, when the first sensing element 1711 and the second sensing element 1712 are connected, it is also beneficial to increase the length and / or area of ​​the sensing element 171. For the sensor 1, the physical properties related to temperature changes are correspondingly enhanced when the length and / or area of ​​the sensing element 171 is increased, and the stronger the physical properties, the easier they are to measure, thereby improving the sensitivity.

[0100] In addition, for the temperature electrode 17 based on resistance change, the first sensing part 1711 and the second sensing part 1712 provided on both sides of the substrate layer 13 make it easier to lengthen the sensing part 171 to increase the resistance of the sensing part 171, thereby improving the sensitivity of the temperature electrode 17.

[0101] In other examples, the sensing element 171 may also be located only on one side of the base layer 13.

[0102] In some examples, the first sensing element 1711 and the second sensing element 1712 can be made of the same material. In this case, the length and / or area of ​​the sensing element 171 can be further increased.

[0103] In some examples, the first sensing element 1711 may be connected to the second sensing element 1712. In some examples, the temperature electrode 17 may also include a connecting portion 1713 for connecting the first sensing element 1711 and the second sensing element 1712. In some examples, the connection between the connecting portion 1713 and the first sensing element 1711 and the second sensing element 1712 may be an electrical connection. In other examples, the connecting portion 1713 may not be included; for example, the first sensing element 1711 and the second sensing element 1712 may be directly connected.

[0104] Furthermore, the material of the connecting portion 1713 can be any material capable of connecting the first sensing portion 1711 and the second sensing portion 1712. In some examples, for the temperature electrode 17 based on resistance change, the connecting portion 1713 can be used to increase the overall resistance of the sensing portion 171.

[0105] In some examples, the material of the connecting portion 1713 can be the same as that of the first sensing portion 1711 and the second sensing portion 1712. This allows for a further increase in the length and / or area of ​​the sensing portion 171. For example, for a temperature electrode 17 based on resistance changes, the connecting portion 1713, made of the same material, is equivalent to adding a new resistor.

[0106] In some examples, the material of the connecting portion 1713 may be different from the material of the first sensing portion 1711 and the second sensing portion 1712. This allows for the selection of a suitable material to improve the filling effect of the through-hole 131. For example, for a temperature electrode 17 based on resistance change, the connecting portion 1713 can be equivalent to connecting the two resistors corresponding to the first sensing portion 1711 and the second sensing portion 1712 in series.

[0107] As described above, in some examples, the substrate 13 may have a through-hole 131. In some examples, a connecting portion 1713 may be provided in the through-hole 131. In this case, it is convenient to connect the first sensing portion 1711 and the second sensing portion 1712 while minimizing the impact on other electrodes (e.g., occupying space for the arrangement of other electrodes). In addition, when the temperature electrode 17 is attached to the substrate 13, the first sensing portion 1711 and the second sensing portion 1712 can be connected without passing through other electrodes via the connecting portion 1713 provided in the through-hole 131.

[0108] In some examples, there can be multiple connectors 1713. These multiple connectors 1713 can be respectively disposed in multiple through-holes 131 of the base layer 13. Therefore, as described above, the reliability of the connection can be improved.

[0109] In some examples, for the thermocouple-based temperature electrode 17, the sensing part 171 may not include the first sensing part 1711 and the second sensing part 1712. Specifically, the sensing part 171 may include two trigger parts made of different materials, and when the two trigger parts come into contact, a thermocouple can be formed at the contact point. For example, the two trigger parts may be two conductive wires made of different materials, and a thermocouple can be formed at the junction of the two conductive wires. In some examples, the different materials may be different metals.

[0110] In some examples, the two triggers can be respectively disposed on both sides of the substrate 13. This allows for the full utilization of the space on both sides of the substrate 13 to arrange the thermocouple-based temperature electrodes 17.

[0111] Figure 5 is a schematic diagram illustrating the structure of a sensor 1 with a second sensing layer 173 provided on the temperature electrode 17 according to an example of this disclosure. Similar reference numerals in the example shown in Figure 5 denote similar components as those in the example shown in Figure 3, and descriptions of these components will not be repeated herein. The main difference between the example shown in Figure 5 and the example in Figure 5 is that the temperature electrode 17 also functions to measure the analyte.

[0112] In some examples, the temperature electrode 17 can also be configured to have the functions of other electrodes in the sensor 1 besides the temperature electrode 17. Generally speaking, the more electrodes there are, the more difficult the fabrication process becomes, and the reliability of the sensor 1 may also be affected. In this case, by enabling the temperature electrode 17 to have multiple functions, the number of electrodes can be reduced, thereby reducing the thickness of the sensor 1 and the complexity of fabricating the sensor 1.

[0113] Preferably, the temperature electrode 17 can be configured to measure the analyte. That is, the temperature electrode 17 can have the functions of measuring temperature and measuring the analyte. In this case, the number of electrodes can be reduced while achieving both temperature and analyte measurement, thereby reducing the thickness of the sensor 1 and the complexity of manufacturing the sensor 1. In addition, the electrode for measuring the analyte is less likely to be shared with other electrodes (e.g., counter electrode 15 and reference electrode 16), making it easier to control the electrode for measuring the analyte (e.g., control its on / off state) to adapt to the corresponding scenario with minimal impact on other electrodes. Specifically, the analyte can be measured once at appropriate time intervals, and during the intervals, the measurement can be switched to temperature.

[0114] Referring to Figure 5, in some examples, the temperature electrode 17 may be provided with a second sensing layer 173. That is, the temperature electrode 17 can also be used to measure the second analyte.

[0115] In some examples, the sensing element 171 may include portions respectively disposed on both sides of the substrate layer 13. In this case, it is convenient to provide a second sensing layer 173 on one side of the sensing element 171 and leave space on the other side for a first sensing layer 141 for arranging a working electrode 14. Specifically, when the sensing element 171 includes a first sensing element 1711 and a second sensing element 1712, the second sensing layer 173 may be disposed on the second sensing element 1712, and the working electrode 14 may be disposed on the first sensing element 1711. In addition, when the sensing element 171 includes portions respectively disposed on both sides of the substrate layer 13, it is also convenient to use a small portion of the sensing element 171 as a wire for measuring the second analyte circuit, thereby reducing the influence of changes in the properties of the sensing element 171 (e.g., resistance changes) on the measurement of the second analyte.

[0116] In some examples, the second analyte may be different from the first analyte. Therefore, multiple analytes can be measured using the temperature electrode 17 and the working electrode 14. In some examples, the second analyte may also be the same as the first analyte. Therefore, multiple measurement results for the same analyte can be obtained. In some examples, the first analyte may be glucose, and the second analyte may be blood ketones or lactic acid.

[0117] In some examples, the sampling frequency corresponding to the first sensing layer 141 can be higher than the sampling frequency corresponding to the second sensing layer 173. That is, the first sensing layer 141 can achieve a higher sampling frequency for the analyte, while the second sensing layer 173 can sample the analyte at a lower frequency. In this case, the electrode with the lower sampling frequency for the analyte is shared with the electrode for measuring temperature to adapt to scenarios with lower sampling frequency requirements without affecting the measurement temperature, while the first sensing layer 141 can still meet the requirements for scenarios with higher sampling frequency requirements.

[0118] Figure 6 is a schematic diagram illustrating that the temperature electrode 17 involved in the example of this disclosure can switch between a first state and a second state. Figure 6 shows the state switching of the temperature electrode 17 based on the change in resistance. It should be noted that this does not represent a limitation of this disclosure, and the temperature electrode 17 can be adjusted accordingly when it changes based on other physical or chemical properties.

[0119] In some examples, the temperature electrode 17, which has a second sensing layer 173, can be configured to switch between a first state and a second state. The first state may be associated with measuring temperature, and the second state may be associated with measuring a second analyte.

[0120] Referring to Figure 6, in some examples, when the temperature electrode 17 is in the first state, the first circuit 174 for measuring temperature can be turned on; when the temperature electrode 17 is in the second state, the second circuit 175 for measuring the second analyte can be turned on. Thus, both temperature measurement and analyte measurement can be achieved through the temperature electrode 17.

[0121] In some examples, a switch SW1 can be configured to switch the conduction of the first circuit 174 and the second circuit 175. It should be noted that the switch SW1 can be any component capable of switching the two circuits, and this disclosure does not limit the design of the switch SW1.

[0122] Referring again to Figure 6, in some examples, for a temperature electrode 17 based on resistance change, in the first circuit 174, the first resistor R11 can represent the resistance corresponding to the temperature electrode 17. For example, for a temperature electrode 17 including a first sensing part 1711 and a second sensing part 1712, when the first sensing part 1711 and the second sensing part 1712 are connected in series, the first resistor R11 can represent the sum of the resistances corresponding to the first sensing part 1711 and the second sensing part 1712.

[0123] In some examples, for the temperature electrode 17 based on resistance change, in the second circuit 175, the second resistor R21 can represent the resistance of the wire (e.g., the resistance present when a portion of the sensing part 171 of the temperature electrode 17 is used as a wire), and the third resistor R22 can represent the resistance corresponding to the sensor signal.

[0124] In some examples, different voltages can be applied to the first circuit 174 and the second circuit 175 respectively to reduce the influence of the sensing part 171 of the temperature electrode 17 as a wire on the second circuit 175.

[0125] In some examples, the first applied voltage V1 (also referred to as the activation voltage) of the first circuit 174 can be greater than the second applied voltage V2 of the second circuit 175. In this case, the voltage applied to the circuit of the analyte is small, and the current change corresponding to the resistance change of the portion of the temperature electrode 17 that is a wire is small and can be ignored compared with the current corresponding to the sensor signal (that is, the effect on the second circuit 175 is negligible).

[0126] In some examples, electronic component 2 may include a temperature control circuit configured to switch the temperature electrode 17 between a first state and a second state. In some examples, the temperature control circuit can switch the temperature electrode 17 between the first state and the second state by controlling the on / off state of the aforementioned switch SW1.

[0127] Referring back to Figure 3, in some examples, the temperature electrode 17 may be disposed on the substrate layer 13. In some examples, the temperature electrode 17 may be a conductive layer formed on the substrate layer 13.

[0128] In some examples, the temperature electrode 17 can be at least partially attached to the substrate layer 13. That is, the temperature electrode 17 can be closest to the substrate layer 13. In other words, the temperature electrode 17 can be in direct contact with the substrate layer 13. In this case, on the one hand, it is convenient to keep the temperature electrode 17 as far away from other electrodes as possible to reduce interference to other electrodes (for example, the current change of the temperature electrode 17 also has a certain impact on other electrodes), and on the other hand, it is convenient to design the structure of the temperature electrode 17 (for example, it is convenient to cover the surface of the substrate layer 13 with the temperature electrode 17, or as mentioned above, it is convenient to connect different parts of the temperature electrode 17 through the through-hole 131 of the substrate layer 13).

[0129] In some examples, the temperature electrode 17 may be covered by an insulating layer 18. This facilitates isolation from the analyte measuring electrode to reduce mutual interference.

[0130] Referring to Figure 4, in some examples, at the distal portion 11, the temperature electrode 17 can be completely covered by the insulating layer 18. That is, the temperature electrode 17 can avoid contact with the body fluid. Thus, it can be isolated from the analyte measuring electrode to avoid mutual interference.

[0131] In some examples, where the temperature electrode 17 has functions other than measuring temperature, the insulating layer 18 can be configured to expose the areas required for these other functions. For example, if the temperature electrode 17 is provided with a second sensing layer 173, the insulating layer 18 may not cover the area corresponding to the second sensing layer 173.

[0132] In some examples, electrodes with functions other than measuring temperature (e.g., working electrode 14, reference electrode 16, and counter electrode 15) can be implemented on the temperature electrode 17. In some examples, electrodes with other functions can be implemented on the insulating layer 18 of the temperature electrode 17.

[0133] In some examples, the working electrode 14 may be disposed on the temperature electrode 17. In some examples, the temperature electrode 17 may be at least partially stacked with the working electrode 14. In some examples, the temperature electrode 17 may be stacked with the working electrode 14 at the distal portion 11. In some examples, when the temperature electrode 17 is stacked with the working electrode 14, the temperature electrode 17 may be in contact with the substrate layer 13. In this case, placing the temperature electrode 17 at the position closest to the substrate layer 13 facilitates reducing the influence of the temperature electrode 17 on the working electrode 14 (e.g., facilitating reducing or completely isolating the temperature electrode 17 from body fluids without affecting the contact of the working electrode 14 with body fluids).

[0134] In some examples, the working electrode 14 may be at least partially stacked with the reference electrode 16 and / or the counter electrode 15. Referring to FIG3, in some examples, the working electrode 14 may be at least partially stacked with the reference electrode 16 and the counter electrode 15, and the reference electrode 16 and the counter electrode 15 are distributed on both sides of the substrate layer 13. In this case, the element distribution on both sides of the substrate layer 13 can be more uniform, which helps to improve the stability of the overall structure and simplifies the fabrication process.

[0135] Figure 7A is a schematic diagram showing a plurality of working electrodes 14 implemented in a parallel manner on the insulating layer 18 of the temperature electrode 17 according to an example of the present disclosure. Figure 7B is a schematic diagram showing a plurality of working electrodes 14 implemented in a stacked manner on the insulating layer 18 of the temperature electrode 17 according to an example of the present disclosure.

[0136] In some examples, multiple working electrodes 14 can be fabricated on the insulating layer 18 of the temperature electrode 17 to measure various analytes (e.g., glucose, blood ketones, and lactic acid). That is, electrodes for measuring different analytes can be further fabricated on the insulating layer 18 of the temperature electrode 17. In some examples, multiple working electrodes 14 can be arranged side-by-side or stacked on the insulating layer 18 of the temperature electrode 17.

[0137] As an example, Figure 7A shows a schematic diagram of multiple working electrodes 14 arranged in parallel, and Figure 7B shows a schematic diagram of multiple working electrodes 14 stacked.

[0138] In some examples, when multiple working electrodes 14 are arranged side by side on the insulating layer 18 of the temperature electrode 17, the reference electrode 16 and the counter electrode 15 may be arranged on the other side of the substrate layer 13.

[0139] In some examples, when multiple working electrodes 14 are stacked on the insulating layer 18 of the temperature electrode 17, the reference electrode 16 and the counter electrode 15 can be respectively disposed on both sides of the substrate layer 13 (refer to FIG. 3). In addition, FIG. 7B also shows the reference electrode 16 located above the working electrode 14 and the stabilizing potential layer 161 of the reference electrode 16.

[0140] Referring back to Figures 3 and 5, in some examples, sensor 1 may also include an insulating layer 18. The insulating layer 18 can be disposed between multiple electrodes. This reduces interference between the multiple electrodes. Additionally, the insulating layer 18 also provides protection, making sensor 1 flexible and improving its bending resistance.

[0141] In some examples, the insulating layer 18 may also cover the electrode. In some examples, the insulating layer 18 may be formed of insulating ink. In some examples, the components of the insulating ink may include resin.

[0142] In some examples, sensor 1 may also include a polymer membrane. Additionally, the polymer membrane can serve as a diffusion-limiting membrane. In other words, the polymer membrane can be used to control the diffusion of the analyte. In some examples, the polymer membrane may at least encapsulate or cover the sensing layer. Thus, the concentration of the analyte reaching the sensing layer can be controlled using the polymer membrane.

[0143] In some examples, the polymer film may wrap around or cover the multiple electrodes described above. For example, the polymer film may wrap around or cover the distal portion 11.

[0144] In some examples, the polymer membrane can be biocompatible. This improves the biocompatibility of sensor 1.

[0145] Figure 8 is an exemplary flowchart illustrating the preparation method according to the present disclosure. Figure 9A is an exemplary flowchart illustrating the preparation of the sensor 1 shown in Figure 3 according to the present disclosure. Figure 9B is a schematic diagram illustrating the preparation of the sensor 1 shown in Figure 3 according to the present disclosure.

[0146] Furthermore, this disclosure also provides a preparation method for fabricating the sensor 1 described above. It should be noted that, unless contradictory, the above description of sensor 1 also applies to this preparation method.

[0147] Referring to Figure 8, the fabrication method may include forming a working electrode 14 on a substrate 13 using a conductive material (step S110). In some examples, a first sensing layer 141 may be disposed on the working electrode 14.

[0148] Referring to Figure 8, the fabrication method may include forming a temperature electrode 17 on the substrate layer 13 (step S120).

[0149] In some examples, the temperature electrode 17 may include a sensing portion 171. The sensing portion 171 may be configured to measure temperature. In some examples, the temperature electrode 17 may also include a lead portion 172. The lead portion 172 may be connected to the sensing portion 171 and may be configured to receive the measured temperature.

[0150] In some examples, the sensing part 171 may be provided in the distal portion 11, the lead part 172 may be connected to the sensing part 171, and the lead part 172 may be partially provided in the distal portion 11.

[0151] In some examples, the sensing element 171 may be made of a first material. In some examples, the lead element 172 may be made of a second material. In some examples, the temperature sensitivity of the second material may be less than that of the first material.

[0152] Furthermore, this disclosure also provides a detailed description of the fabrication process of the sensor 1 illustrated in Figure 3, using screen printing as an example, wherein the conductive material is in the form of conductive ink. It should be noted that this does not constitute a limitation of this disclosure.

[0153] In the sensor 1 illustrated in Figure 3, there are 5 electrodes, including 2 working electrodes 14, 1 reference electrode 16, 1 counter electrode 15, and 1 temperature electrode 17. The sensing part 171 of the temperature electrode 17 includes a first sensing part 1711 and a second sensing part 1712. It can also be considered that the temperature electrode 17 is actually composed of two electrodes.

[0154] Referring to Figures 9A and 9B, the preparation process may include:

[0155] Step S210: Use a laser device to create a hole 131 (e.g., a micropore) on the substrate layer 13.

[0156] Step S220: Fill the through hole 131 with conductive ink on the printing press.

[0157] Step S230: Conductive ink with added temperature-sensitive material is printed on a portion of the front and back sides of the substrate layer 13, and then conductive ink is printed on another portion to splice the layers corresponding to the conductive ink with added temperature-sensitive material, thereby forming the temperature electrode 17.

[0158] Step S240: Print an insulating layer 18 (e.g., insulating ink) on the temperature electrodes 17 on both sides of the substrate layer 13.

[0159] Step S250: Print a working electrode 14 and a corresponding insulating layer 18 on the insulating layers 18 corresponding to the temperature electrodes 17 on both sides of the substrate layer 13. That is, two working electrodes 14 and corresponding insulating layers 18 are formed.

[0160] Step S260: Print conductive ink for the reference electrode 16 on the insulating layer 18 corresponding to the working electrode 14 on the front side of the substrate layer 13, and then print silver / silver chloride on a portion of the reference electrode 16 and the insulating layer 18 on the other portion.

[0161] Step S270: Print conductive ink for counter electrode 15 on insulating layer 18 corresponding to working electrode 14 on the reverse side of substrate layer 13, and then print insulating layer 18 on counter electrode 15.

[0162] Step S280: Coat the two working electrodes 14 with the first sensing layer 141 respectively.

[0163] Step S290: Coat the distal portion 11 (e.g., the tip portion) of the sensor 1 with a polymer film.

[0164] While the present disclosure has been specifically described above in conjunction with the accompanying drawings and examples, it is to be understood that the foregoing description does not limit the present disclosure in any way. Those skilled in the art can make modifications and variations to the present disclosure as needed without departing from its essential spirit and scope, and all such modifications and variations shall fall within the scope of the present disclosure.

Claims

1. A biosensor comprising a distal portion for measuring a signal related to an analyte level and a proximal portion connected to the distal portion, characterized in that, The biosensor further comprises a substrate layer, a working electrode provided with a first sensing layer, and a temperature electrode; the working electrode is disposed on the substrate layer and formed of an electrically conductive material; the temperature electrode is disposed on the substrate layer and comprises a sensing portion disposed at the distal end portion and a lead portion connected with the sensing portion and partially disposed at the distal end portion, the temperature sensitivity of the lead portion is less than that of the sensing portion.

2. The biosensor of claim 1, wherein, At the distal end portion, the temperature electrode is stacked with the working electrode, and the temperature electrode is attached to the substrate layer.

3. The biosensor according to claim 1 or 2, characterized in that, The sensing portion comprises a first sensing portion and a second sensing portion connected with the first sensing portion, which are respectively disposed on two sides of the substrate layer.

4. The biosensor of claim 3, wherein, The first sensing portion and the second sensing portion are made of the same material.

5. The biosensor of claim 3, wherein, The temperature electrode further comprises a connecting portion for electrically connecting the first sensing portion and the second sensing portion, the substrate layer has a plurality of through holes, and the connecting portion is disposed in the through holes.

6. The biosensor of claim 5, wherein, The spacing distance between the through holes in the plurality of through holes is less than a preset distance.

7. The biosensor according to any one of claims 1 to 2, 4 to 6, wherein, The sensing portion and the lead portion are located at the same layer relative to the substrate layer and at least partially overlap.

8. The biosensor according to any one of claims 1 to 2, 4 to 6, wherein, Further comprising an insulating layer, the insulating layer completely covers the sensing portion.

9. The biosensor of claims 1-2, 4-6, wherein, The temperature electrode is provided with a second sensing layer and is configured to be switchable between a first state and a second state, when the temperature electrode is in the first state, a first circuit for measuring temperature is turned on, and when the temperature electrode is in the second state, a second circuit for measuring an analyte corresponding to the second sensing layer is turned on.

10. The biosensor of claim 9, wherein, The first applied voltage of the first circuit is greater than the second applied voltage of the second circuit.

11. A method of producing a biosensor according to any one of claims 1 to 10, said biosensor comprising a distal portion for measuring a signal related to the level of an analyte and a proximal portion connected to said distal portion, characterized in that, The preparation method comprises forming a working electrode on a substrate layer from an electrically conductive material, disposing a first sensing layer on the working electrode; and forming a temperature electrode on the substrate layer, the temperature electrode comprises a sensing portion disposed at the distal end portion and a lead portion connected with the sensing portion and partially disposed at the distal end portion, the temperature sensitivity of the lead portion is less than that of the sensing portion.

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