Method for measuring concentration of target analyte, biosensor, and related apparatus

Abstract

Disclosed in the present application are a method for measuring the concentration of a target analyte, a biosensor, and a related apparatus. The biosensor disclosed in the present application comprises a first working electrode and a second working electrode. When a tip portion of the biosensor is implanted subcutaneously along with a hard needle, the second working electrode is closer to a tip of the hard needle than the first working electrode. The first working electrode is provided with an active enzyme. The first working electrode generates a first current after being implanted subcutaneously, and the first current comprises: a current generated by the reaction between the target analyte and the active enzyme and a current generated by the reaction between an interferent and the first working electrode. The second working electrode is provided with an inactive enzyme. The second working electrode generates a second current after being implanted subcutaneously, and the second current comprises: a current generated by the reaction between the interferent and the second working electrode. In this way, the influence of the interferent can be eliminated by means of the first current and the second current, thereby improving the calculation accuracy of the concentration of the target analyte.

Description

A method, biosensor, and related device for detecting the concentration of a target analyte.

[0001] This application claims priority to Chinese Patent Application No. 202411900031.2, filed on December 19, 2024, with the China National Intellectual Property Administration, entitled “A method for detecting the concentration of a target analyte, a biosensor and related apparatus”, the entire contents of which are incorporated herein by reference. Technical Field

[0002] This application relates to the field of biosensing technology, and in particular to a method for detecting the concentration of a target analyte, a biosensor, and related devices. Background Technology

[0003] Diabetes mellitus is a metabolic disease characterized by hyperglycemia, caused by defects in insulin secretion and impaired biological action. Continuous monitoring of blood glucose levels in diabetic patients is crucial for its treatment. Currently, commercially available continuous glucose monitoring products work by implanting biosensors under the skin to monitor changes in glucose levels in tissue fluid, thereby reflecting the user's blood glucose concentration.

[0004] However, after a biosensor is implanted under the skin, some electrochemical substances in the body, such as ascorbic acid, uric acid, and acetaminophen, can interfere with the sensor's current response, resulting in inaccurate detection results.

[0005] Therefore, how to enable biosensors to eliminate interference from electroactive substances such as ascorbic acid is a problem that urgently needs to be solved. Summary of the Invention

[0006] This application provides a method, a biosensor, and a related device for detecting the concentration of a target analyte, which eliminates interference from electroactive substances when detecting the concentration of the target analyte.

[0007] In a first aspect, embodiments of this application provide a biosensor comprising: a first working electrode and a second working electrode, wherein when the tip of the biosensor is implanted subcutaneously with a hard needle, the second working electrode is closer to the tip of the hard needle than the first working electrode; the first working electrode includes a first enzyme dot, wherein an active enzyme is disposed on the first enzyme dot, and the first working electrode generates a first current after being implanted subcutaneously, the first current including: a current generated by the reaction of the target analyte with the active enzyme, and a current generated by the reaction of an interfering substance with the first working electrode; the second working electrode includes a second enzyme dot, wherein an inactivating enzyme is disposed on the second enzyme dot, and the second working electrode generates a second current after being implanted subcutaneously, the second current including: a current generated by the reaction of an interfering substance with the second working electrode.

[0008] As can be seen, the embodiments of this application provide a biosensor comprising two working electrodes: one with an active enzyme and the other with an inactivating enzyme. The current generated by these two working electrodes can eliminate the influence of electroactive interfering substances on the detection of the target analyte. Furthermore, the second working electrode is closer to the tip of the hard needle than the first working electrode. Therefore, if the biosensor exhibits early attenuation or late failure, the first working electrode, being farther from the needle tip, is less susceptible to this phenomenon, thereby further improving the accuracy of the target analyte detection.

[0009] In conjunction with the first aspect, in the first implementation, the first working electrode and the second working electrode are placed side by side along the implantation direction, or the first working electrode and the second working electrode are placed sequentially along the implantation direction.

[0010] In conjunction with the first aspect, in the second implementation, the first working electrode includes N first enzyme spots, and the second working electrode includes N second enzyme spots, where N ≥ 1.

[0011] In other words, the first working electrode and the second working electrode can contain the same number of enzyme dots, and the enzyme dots on the first working electrode are all used to set active enzymes, while the enzyme dots on the second working electrode are all used to set inactive enzymes.

[0012] In conjunction with the first aspect, in the third implementation, the second working electrode also includes a second enzyme spot, and the second current also includes: the current generated by the reaction of the target analyte with the active enzyme; the first current and the second current are used to identify early decay or late failure of the biosensor.

[0013] In other words, the second working electrode can be equipped with both active and inactivating enzymes. In this way, in addition to determining the concentration of the target analyte by the current generated by the first and second working electrodes, the early decay and late failure of the biosensor can also be identified based on the current.

[0014] In conjunction with the first aspect, in the fourth implementation, the first working electrode includes N first enzyme spots, and the second working electrode includes X first enzyme spots and (NX) second enzyme spots, where N≥2 and X≥1.

[0015] In other words, the first working electrode and the second working electrode can contain the same number of enzyme dots, wherein all enzyme dots on the first working electrode are used to set active enzymes, and some enzyme dots on the second working electrode are used to set active enzymes and some enzyme dots are used to set inactive enzymes.

[0016] In conjunction with the first aspect, in the fifth implementation, X first enzyme dots are close to the electrode tip of the second working electrode, and (NX) second enzyme dots are far from the electrode tip of the second working electrode.

[0017] The active enzyme on the second working electrode is located close to the electrode tip, while the inactivated enzyme is located far from the electrode tip, which can enhance the detection sensitivity of the second working electrode for early decay or late failure.

[0018] In conjunction with the first aspect, in the sixth implementation, the first working electrode includes Y first enzyme spots and (NY) second enzyme spots, and the second working electrode includes X first enzyme spots and (NX) second enzyme spots, wherein N≥2, X≥1, and Y≥1.

[0019] In other words, the first working electrode and the second working electrode can contain the same number of enzyme dots, wherein some enzyme dots on the first working electrode are used to set active enzymes and some enzyme dots are used to set inactive enzymes, and similarly, some enzyme dots on the second working electrode are used to set active enzymes and some enzyme dots are used to set inactive enzymes.

[0020] In conjunction with the first aspect, in the seventh implementation, Y first enzyme dots are far from the electrode tip of the first working electrode, and (NY) second enzyme dots are close to the electrode tip of the first working electrode; X first enzyme dots are close to the electrode tip of the second working electrode, and (NX) second enzyme dots are far from the electrode tip of the second working electrode.

[0021] The active enzyme on the first working electrode is far from the electrode tip, while the inactivated enzyme is close to the electrode tip. This reduces the impact of early decay and late failure on the concentration of the target analyte detected by the first working electrode. The active enzyme on the second working electrode is close to the electrode tip, while the inactivated enzyme is far from the electrode tip. This enhances the detection sensitivity of the second working electrode for early decay or late failure.

[0022] In conjunction with the first aspect, in the eighth implementation method, the enzyme is glucose oxidase and the target analyte is glucose.

[0023] Therefore, the biosensor provided in this application embodiment can refer to a glucose sensor, which is used to detect the blood glucose concentration in the user's body.

[0024] Secondly, embodiments of this application provide an apparatus comprising: a biosensor and a processor; the biosensor is a biosensor as described in any implementation of the first aspect, the processor is connected to a first working electrode and a second working electrode respectively, and the processor is configured to determine the concentration of a target analyte in a user's body based on a first current and a second current, or to determine a third current based on the first current and the second current, and to send the third current to a first device, wherein the third current is related to the concentration of the target analyte in the user's body.

[0025] As can be seen, embodiments of this application provide a device that can acquire the current generated by a biosensor and determine the concentration of a target analyte in a user's body based on the current, or calculate an intermediate value related to the concentration of the target analyte in the user's body and send the intermediate value to other devices so that other devices can calculate the concentration of the target analyte in the user's body based on the intermediate value.

[0026] In conjunction with the second aspect, in one implementation, the biosensor is a biosensor as described in any of the second to eighth implementations of the first aspect, and the processor is used to determine the concentration of the target analyte in the user's body based on the difference between the first current and the second current, or the third current is the difference between the first current and the second current.

[0027] In other words, the concentration of the target analyte in the user's body can be determined based on the difference in current between the first working electrode and the second working electrode.

[0028] In conjunction with the second aspect, in one implementation, the biosensor is a biosensor as described in the third implementation of the first aspect, and the processor is further configured to identify early attenuation or late failure of the biosensor based on a first current and a second current; if the processor identifies that the biosensor has experienced early attenuation or late failure, the processor is configured to determine the concentration of the target analyte in the user's body based on the first current and the second current, or a third current is determined based on the first current and the second current; if the processor identifies that the biosensor has not experienced early attenuation or late failure, the processor is configured to determine the concentration of the target analyte in the user's body based on the first current, or a third current is determined based on the first current.

[0029] In other words, if the first working electrode contains an active enzyme and the second working electrode contains both an active enzyme and an inactivating enzyme, the device can also identify early attenuation or late failure of the biosensor based on the current at the first and second working electrodes. Furthermore, it can select different currents to determine the concentration of the target analyte in the user's body based on whether early attenuation or late failure has occurred. This improves the accuracy of detecting the concentration of the target analyte in the user's body when early attenuation or late failure of the biosensor occurs, and reduces the impact of early attenuation or late failure on the detection accuracy of the biosensor.

[0030] In conjunction with the second aspect, in one implementation, the biosensor is a biosensor as described in the fourth or fifth implementation of the first aspect, and the processor is further configured to identify early attenuation or late failure of the biosensor based on N, X, a first current, and a second current; if the processor identifies that the biosensor has experienced early attenuation or late failure, the processor is configured to determine the concentration of the target analyte in the user's body based on the first current and the second current, or a third current is determined based on the first current and the second current; if the processor identifies that the biosensor has not experienced early attenuation or late failure, the processor is configured to determine the concentration of the target analyte in the user's body based on the first current, or the third current is the first current.

[0031] In other words, if the first working electrode includes N first enzyme dots, and the second working electrode includes X first enzyme dots and (NX) second enzyme dots, then early decay or late failure of the biosensor can be identified based on N, X, and the first and second currents. This can improve the detection accuracy of the concentration of the target analyte in the user's body when the biosensor exhibits early decay or late failure, and reduce the impact of early decay or late failure on the detection accuracy of the biosensor.

[0032] In conjunction with the second aspect, in one implementation, the biosensor is a biosensor as described in the sixth or seventh implementation of the first aspect, and the processor is further configured to identify early attenuation or late failure of the biosensor based on X, Y, a first current, and a second current; if the processor identifies that the biosensor has experienced early attenuation or late failure, the processor is configured to determine the concentration of the target analyte in the user's body based on the first current and the second current, or a third current is determined based on the first current and the second current; if the processor identifies that the biosensor has not experienced early attenuation or late failure, the processor is configured to determine the concentration of the target analyte in the user's body based on the first current, or a third current is determined based on the first current.

[0033] In other words, if the first working electrode includes Y first enzyme dots and (NY) second enzyme dots, and the second working electrode includes X first enzyme dots and (NX) second enzyme dots, then early decay or late failure of the biosensor can be identified based on X, Y, and the first and second currents. This can improve the accuracy of detecting the concentration of target analytes in the user's body when early decay or late failure of the biosensor occurs, and reduce the impact of early decay or late failure on the detection accuracy of the biosensor.

[0034] In conjunction with the second aspect, in one implementation, when the processor detects that the biosensor has experienced early degradation or late failure, the processor is also used to output first information, which indicates that the biosensor has experienced early degradation or late failure.

[0035] Furthermore, the device can output a prompt message when outputting the first information, reminding the user that the biosensor has experienced early attenuation or late failure. Alternatively, the device can send the first information to other devices so that other devices can determine the implantation status of the device based on the first information.

[0036] In conjunction with the second aspect, in one implementation, when the processor detects that the biosensor has experienced early attenuation or late failure, the processor is also used to identify whether the phenomenon is early attenuation or late failure based on the implantation time of the biosensor.

[0037] In other words, the timing of biosensor implantation can be used to specifically analyze whether the phenomena observed in the biosensor are early attenuation or late failure.

[0038] In conjunction with the second aspect, in one implementation, the biosensor is a biosensor as described in the fourth or fifth implementation of the first aspect, and the processor is used to determine the concentration of the target analyte in the user's body based on a third current, wherein the third current is... Where I1 represents the first current and I2 represents the second current.

[0039] As can be seen, the processor can determine the concentration of the target analyte in the user's body based on the difference between the first current and the second current, as well as N and X.

[0040] In conjunction with the second aspect, in one implementation, the biosensor is a biosensor as described in the fourth or fifth implementation of the first aspect, and the processor is used to determine the concentration of the target analyte in the user's body based on the third current; In this case, the third current is Where I1 represents the first current and I2 represents the second current; in In this case, the third current is I1.

[0041] It can be seen that by analyzing the differences between N, X, the first current and the second current after certain calculations and the threshold (e.g., 0), a certain formula can be used to identify whether the biosensor has experienced early decay or late failure, and then choose to use the first current and the second current or the first current to determine the concentration of the target analyte in the user's body or the third current.

[0042] In conjunction with the second aspect, in one implementation, the processor is also used to... In this case, the first information is output, which is used to indicate that the biosensor has experienced early decay or late failure.

[0043] In other words, it can output information indicating that the biosensor has experienced early degradation or late failure when it is detected that the biosensor has experienced early degradation or late failure.

[0044] In conjunction with the second aspect, in one implementation method, in Furthermore, when the biosensor is in the preset period immediately after implantation under the skin, the first information is used to indicate that the biosensor has experienced early degradation; Furthermore, if the biosensor is within a preset time period before failure, the first information is used to indicate that the biosensor has experienced late failure.

[0045] Therefore, we can analyze whether the phenomenon of biosensor is early attenuation or late failure by combining the implantation time of the biosensor.

[0046] In conjunction with the second aspect, in one implementation, the biosensor is a biosensor as described in the sixth or seventh implementation of the first aspect, and the processor is used to determine the concentration of the target analyte in the user's body based on a third current, wherein the third current is... Where I1 represents the first current and I2 represents the second current.

[0047] As can be seen, the processor can determine the concentration of the target analyte in the user's body based on the difference between the first current and the second current, as well as N, X, and Y.

[0048] In conjunction with the second aspect, in one implementation, the biosensor is a biosensor as described in the sixth or seventh implementation of the first aspect, and the processor is used to determine the concentration of the target analyte in the user's body based on the third current; In this case, the third current is Where I1 represents the first current and I2 represents the second current; in In this case, the third current is

[0049] It can be seen that by analyzing the differences between X, Y, the first current and the second current after certain calculations and the threshold (e.g., 0), a certain formula can be used to identify whether the biosensor has experienced early decay or late failure, and then choose to use the first current and the second current or the first current to determine the concentration of the target analyte in the user's body or the third current.

[0050] In conjunction with the second aspect, in one implementation, the processor is used to... In this case, a second piece of information is output, which is used to indicate that the biosensor has experienced early decay or late failure.

[0051] In other words, it can output information indicating that the biosensor has experienced early degradation or late failure when it is detected that the biosensor has experienced early degradation or late failure.

[0052] In conjunction with the second aspect, in one implementation method, in Furthermore, when the biosensor is in a preset period immediately after implantation under the skin, the second information is used to indicate that the biosensor has experienced early degradation; Furthermore, if the biosensor is within a preset time period before failure, the second information is used to indicate that the biosensor has experienced late failure.

[0053] Therefore, we can analyze whether the phenomenon of biosensor is early attenuation or late failure by combining the implantation time of the biosensor.

[0054] Thirdly, embodiments of this application provide a method for detecting the concentration of a target analyte. The method is applied to a device, which is the device described in the second aspect or any implementation thereof. The method includes: acquiring a first current generated after a first working electrode is implanted subcutaneously; acquiring a second current generated after a second working electrode is implanted subcutaneously; determining the concentration of the target analyte in the user's body based on the first current and the second current, or determining a third current based on the first current and the second current, and sending the third current to a first device, wherein the third current is related to the concentration of the target analyte in the user's body.

[0055] In conjunction with the third aspect, in one implementation, the biosensor is a biosensor as described in any of the second to eighth implementations of the first aspect, determining the concentration of the target analyte in the user's body based on a first current and a second current, specifically including: determining the concentration of the target analyte in the user's body based on the difference between the first current and the second current; or, the third current is the difference between the first current and the second current.

[0056] In conjunction with the third aspect, in one implementation, the biosensor is a biosensor as described in the third implementation of the first aspect, determining the concentration of a target analyte in the user's body based on a first current and a second current, specifically including: identifying early decay or late failure of the biosensor based on the first current and the second current; if early decay or late failure of the biosensor is identified, determining the concentration of the target analyte in the user's body based on the first current and the second current; if early decay or late failure of the biosensor is not identified, determining the concentration of the target analyte in the user's body based on the first current.

[0057] In conjunction with the third aspect, in one implementation, the biosensor is a biosensor as described in the fourth or fifth implementation of the first aspect, and the concentration of the target analyte in the user's body is determined based on a first current and a second current, specifically including: identifying early decay or late failure of the biosensor based on N, X, the first current, and the second current; if early decay or late failure of the biosensor is identified, determining the concentration of the target analyte in the user's body based on the first current and the second current; if early decay or late failure of the biosensor is not identified, determining the concentration of the target analyte in the user's body based on the first current.

[0058] In conjunction with the third aspect, in one implementation, the biosensor is the biosensor described in the sixth or seventh implementation of the first aspect, and the concentration of the target analyte in the user's body is determined based on a first current and a second current, specifically including: identifying early decay or late failure of the biosensor based on X, Y, the first current, and the second current; if early decay or late failure of the biosensor is identified, determining the concentration of the target analyte in the user's body based on the first current and the second current; if early decay or late failure of the biosensor is not identified, determining the concentration of the target analyte in the user's body based on the first current.

[0059] In conjunction with the third aspect, in one implementation, the method further includes: upon detecting that the biosensor has experienced early degradation or late failure, outputting first information, the first information being used to indicate that the biosensor has experienced early degradation or late failure.

[0060] In conjunction with the third aspect, in one implementation, the method further includes: when early attenuation or late failure of the biosensor is detected, identifying whether the phenomenon is early attenuation or late failure based on the implantation time of the biosensor.

[0061] In conjunction with the third aspect, in one implementation, the biosensor is a biosensor as described in the fourth or fifth implementation of the first aspect; determining the concentration of the target analyte in the user's body based on a first current and a second current specifically includes: determining a third current based on the first current and the second current, and determining the concentration of the target analyte in the user's body based on the third current; the third current is... Where I1 represents the first current and I2 represents the second current.

[0062] In conjunction with the third aspect, in one implementation, the biosensor is a biosensor as described in the fourth or fifth implementation of the first aspect, determining the concentration of a target analyte in the user's body based on a first current and a second current, specifically including: determining a third current based on the first current and the second current, and determining the concentration of the target analyte in the user's body based on the third current; In this case, the third current is Where I1 represents the first current and I2 represents the second current; in In this case, the third current is I1.

[0063] In conjunction with the third aspect, in one implementation, the method further includes: in In this case, the first information is output, which is used to indicate that the biosensor has experienced early decay or late failure.

[0064] In conjunction with the third aspect, in one implementation method, in Furthermore, when the biosensor is in the preset period immediately after implantation under the skin, the first information is used to indicate that the biosensor has experienced early degradation; Furthermore, if the biosensor is within a preset time period before failure, the first information is used to indicate that the biosensor has experienced late failure.

[0065] In conjunction with the third aspect, in one implementation, the biosensor is a biosensor as described in the sixth or seventh implementation of the first aspect; determining the concentration of the target analyte in the user's body based on a first current and a second current specifically includes: determining a third current based on the first current and the second current, and determining the concentration of the target analyte in the user's body based on the third current; the third current is... Where I1 represents the first current and I2 represents the second current.

[0066] In conjunction with the third aspect, in one implementation, the biosensor is a biosensor as described in the sixth or seventh implementation of the first aspect, in In this case, the third current is Where I1 represents the first current and I2 represents the second current; in In this case, the third current is

[0067] In conjunction with the third aspect, in one implementation, the method further includes: in In this case, a second piece of information is output, which is used to indicate that the biosensor has experienced early decay or late failure.

[0068] In conjunction with the third aspect, in one implementation method, in Furthermore, when the biosensor is in a preset period immediately after implantation under the skin, the second information is used to indicate that the biosensor has experienced early degradation; Furthermore, if the biosensor is within a preset time period before failure, the second information is used to indicate that the biosensor has experienced late failure.

[0069] Fourthly, embodiments of this application provide an electronic device, including: a memory, a processor, and a computer program stored in the memory, wherein the processor executes the computer program to implement the method as described in the third aspect or any implementation thereof.

[0070] Fifthly, embodiments of this application provide a computer-readable storage medium having a computer program stored thereon, which, when executed by a processor, implements the method as described in the third aspect or any of the implementations of the third aspect.

[0071] Sixthly, embodiments of this application provide a computer program product, which includes a computer program that, when executed by a processor, implements the method described in the third aspect or any of the implementations of the third aspect.

[0072] In a seventh aspect, embodiments of this application provide a chip system, which includes a processing circuit and an interface circuit. The interface circuit is used to receive computer instructions and transmit them to the processing circuit. The processing circuit is used to execute the computer instructions to implement the method described in the third aspect or any of the implementations of the third aspect. Attached Figure Description

[0073] Figure 1 is a schematic diagram of the detection principle of the CGM device provided in the embodiment of this application;

[0074] Figure 2 is a schematic diagram of the relevant circuit of the biosensor provided in the embodiment of this application;

[0075] Figure 3 is a schematic diagram showing the positions of the first and second working electrodes on the biosensor provided in the embodiments of this application;

[0076] Figure 4 is a schematic diagram of the first and second working electrodes provided in the embodiments of this application after enzyme dots are set;

[0077] Figure 5 is another schematic diagram of the first and second working electrodes provided in the embodiments of this application after enzyme dots are set;

[0078] Figure 6 is a schematic diagram showing the relative positions of the first working electrode and the second working electrode with the hard needle provided in the embodiment of this application;

[0079] Figure 7 is a schematic diagram of a first working electrode and a second working electrode provided in an embodiment of this application;

[0080] Figure 8 is another schematic diagram of the first and second working electrodes provided in the embodiments of this application after enzyme dots are set;

[0081] Figure 9 is a schematic diagram of another first working electrode and a second working electrode provided in an embodiment of this application;

[0082] Figure 10 is a schematic flowchart of a method for detecting the concentration of a target analyte according to an embodiment of this application;

[0083] Figure 11 is a schematic diagram of the structure of the device 100 provided in the embodiment of this application. Detailed Implementation

[0084] The technical solutions in the embodiments of this application will be clearly and thoroughly described below with reference to the accompanying drawings.

[0085] A biosensor is an instrument that is sensitive to biological substances and can convert their concentration into an electrical signal for detection. Among them, the glucose sensor is one of the most studied sensors in the field of biosensors, and it can be used to detect the glucose concentration in the human body, that is, the user's blood sugar level.

[0086] Currently, glucose sensors are commonly used in continuous glucose monitoring (CGM) devices, allowing users to monitor their blood sugar levels in real time by wearing a CGM device.

[0087] Figure 1 is a schematic diagram of the detection principle of CGM equipment.

[0088] As shown in Figure 1, the CGM device includes a glucose sensor and a processing device for processing electrical signals. During dynamic blood glucose monitoring, a portion of the glucose sensor can be implanted under the skin. The working electrode of the glucose sensor is equipped with glucose oxidase, which can react electrochemically with glucose molecules at the implantation site to generate an electrical signal. The processing device in the CGM device processes the electrical signal to calculate the user's blood glucose value.

[0089] Furthermore, if the user ingests a large amount of ascorbic acid (i.e., vitamin C), ascorbic acid will also be present at the implantation site. Ascorbic acid will also react chemically with the working electrode to generate an electrical signal, resulting in an increase in the electrical signal acquired by the glucose sensor. This could cause the CGM device to output false positive monitoring results or miss the warning of the user's hypoglycemia symptoms.

[0090] Therefore, this solution proposes a biosensor to address this problem. The biosensor includes two working electrodes: a first working electrode and a second working electrode. The first working electrode contains an active glucose oxidase, while the second working electrode contains an inactive (i.e., deactivated) glucose oxidase. Thus, if the user's body contains ascorbic acid, both the first and second working electrodes can receive the current generated by the reaction between ascorbic acid and the electrode. Because the first working electrode contains active glucose oxidase, it can undergo an electrochemical reaction with glucose in the user's body, while the second working electrode contains inactive glucose oxidase, it cannot undergo an electrochemical reaction with glucose in the user's body. Therefore, the first working electrode can also receive the current generated by the reaction between glucose and the electrode, compared to the second working electrode. By processing the current received by the first and second working electrodes, the interference from ascorbic acid in the user's body can be eliminated, and the user's blood glucose concentration can be calculated.

[0091] As can be seen, the biosensor provided in this application embodiment has an additional working electrode, on which an inactivating enzyme is set, which can eliminate the interference of ascorbic acid and improve the accuracy of blood glucose concentration detection.

[0092] It should be understood that, in addition to glucose sensors, the biosensors mentioned in the embodiments of this application can also refer to other biosensors, such as uric acid detection sensors for detecting uric acid, cholesterol detection sensors for detecting cholesterol, etc., simply by replacing the enzyme on the working electrode with an enzyme that undergoes an electrochemical reaction with the target analyte. Furthermore, substances that interfere with the detection of the target analyte are not limited to ascorbic acid mentioned above, but can also refer to active substances such as acetaminophen, uric acid, acetylsalicylic acid, lactic acid, and ibuprofen. For ease of description, substances that interfere with the detection of the target analyte will be referred to as interfering substances, active enzymes as active enzymes, and inactive enzymes as inactivating enzymes.

[0093] Figure 2 is a schematic diagram of the relevant circuit of the biosensor provided in the embodiment of this application.

[0094] As shown in Figure 2, a biosensor may include four types of electrodes: a first working electrode, a second working electrode, a reference electrode, and a counter electrode, wherein:

[0095] The first working electrode is used to detect the target analyte in the blood. The first working electrode is equipped with an active enzyme. Specifically, the concentration of the target analyte in the blood or tissue fluid can be calculated by the electrical signal generated by the electrochemical reaction between the active enzyme and the target analyte in the blood.

[0096] The second working electrode is an anti-interference electrode, which is equipped with an inactivating enzyme. Specifically, the interference of interfering substances in the blood on the calculation of the concentration of the target analyte can be eliminated by differential processing of the current signals received by the first and second working electrodes.

[0097] A reference electrode is used to provide a constant potential during electrochemical measurements to calibrate the potential of the working electrode. The reference electrode ensures the accuracy and stability of the measurement. For example, a silver / silver chloride (Ag / AgCl) electrode is typically used as the reference electrode.

[0098] The counter electrode, also known as the timing electrode or auxiliary electrode, is the electrode that corresponds to the working electrode in an electrochemical reaction. It is typically used in conjunction with the working electrode to provide the supply or reception of electrons. For example, platinum (Pt) or carbon (C) are commonly chosen as the counter electrode.

[0099] Understandably, if the biosensor is a glucose sensor, then the target analyte can be glucose, the active enzyme can be active glucose oxidase, and the inactive enzyme can be inactive glucose oxidase.

[0100] For example, in the circuit diagram shown in Figure 2, a biosensor includes a first working electrode, a second working electrode, a reference electrode, and a counter electrode. It should be understood that in other embodiments of this application, the number of the first working electrode, the second working electrode, the reference electrode, and the counter electrode in the biosensor may include one or more. The embodiments of this application do not limit the number of these four types of electrodes included in the biosensor.

[0101] In addition, the circuit diagram shown in Figure 2 also includes: operational amplifier OP1, operational amplifier OP2, operational amplifier OP3, resistors R1, R2, R3, and R4, a voltage regulator, an analog-to-digital converter (ADC), a microcontroller unit (MCU), and an antenna. Among them:

[0102] The output of operational amplifier OP1 is connected to pin 1 of the ADC. The inverting input of operational amplifier OP1 is connected to the first working electrode. The inverting input and output of operational amplifier OP1 are also connected through resistor R1. The non-inverting input of operational amplifier OP1 is connected to the voltage regulator, the non-inverting input of operational amplifier OP2, and pin 3 of the ADC.

[0103] The output of operational amplifier OP2 is connected to pin 2 of ADC. The inverting input of operational amplifier OP2 is connected to the second working electrode. The inverting input and output of operational amplifier OP2 are also connected through resistor R2.

[0104] The output terminal of operational amplifier OP3 is connected to the counter electrode, the inverting input terminal of operational amplifier OP3 is connected to the reference electrode, the non-inverting input terminal of operational amplifier OP3 is connected to resistors R3 and R4 respectively, the other end of R4 is grounded, and the other end of R3 is connected to the voltage regulator.

[0105] The voltage regulator is used to provide a stable voltage reference value. For example, the voltage regulator can be a low dropout regulator (LDO). Operational amplifiers OP1, OP2, OP3, resistors R1, R2, R3, and R4 are devices in the analog front end, used to convert the current signal I1 output from the first working electrode and the current signal I2 output from the second working electrode into voltage signals, and transmit the converted voltage signals U1, U2, and U3 to the ADC.

[0106] Pin 4 of the ADC is connected to the MCU. The ADC is used to convert analog signals into digital signals. Specifically, the ADC can convert the received voltage signals U1, U2, and U3 into digital signals and transmit them to the MCU.

[0107] The MCU can calculate the current signal I1 of the first working electrode and the current signal I2 of the second working electrode based on the received digital signal. Then, based on a certain formula, it calculates the current signal positively correlated with the concentration of the target analyte after eliminating the influence of interfering substances. This allows the MCU to analyze the concentration of the target analyte in the user's body based on the current signal positively correlated with the concentration of the target analyte. Furthermore, the MCU can send the calculated current signal positively correlated with the concentration of the target analyte to other devices, such as a mobile phone, through a communication module (e.g., a communication module integrated into the MCU). In this way, other devices can calculate the concentration of the target analyte in the user's body using the current signal positively correlated with the concentration of the target analyte. For example, the communication module can be a Bluetooth module.

[0108] For example, if the MCU contains an algorithm that calculates the concentration of the target analyte using a current signal that is positively correlated with the concentration of the target analyte, the MCU can directly calculate the concentration of the target analyte in the user's body and send the calculation result to other devices, such as a mobile phone, through a communication module.

[0109] In one implementation, all the devices in Figure 2 can be devices in device 100. For example, if the biosensor is a glucose sensor, then device 100 can be a CGM device. That is, device 100 can calculate a current signal positively correlated with the concentration of the target analyte based on the signal generated by the biosensor after subcutaneous implantation, and send the current signal to other devices. Alternatively, device 100 can calculate the concentration of the target analyte in the user's body based on the current signal and send the calculation result to other devices.

[0110] For details regarding the MCU's processing of the current signal I1 from the first working electrode and the current signal I2 from the second working electrode, please refer to Formulas 1-7 below. For a detailed description of the process by which the device 100 detects the concentration of the target analyte, please refer to the relevant content in Figure 10 below.

[0111] It is understood that the circuit diagram shown in Figure 2 is only an exemplary example. In actual circuits, there may be more or fewer components, and the embodiments of this application do not limit this.

[0112] Since the biosensor provided in this application embodiment contains four types of electrodes, there are various designs for the placement of these four types of electrodes.

[0113] In one example, the first and second working electrodes can be located on the same side of the biosensor. Furthermore, the reference and counter electrodes can be located on the other side of the biosensor. This minimizes the fabrication steps involved in adding a new working electrode and ensures that the first and second working electrodes are in the same environment, improving the consistency of their detection of interfering substances and enhancing the accuracy of target analyte concentration calculation.

[0114] It is understood that the first working electrode and the second working electrode may also be located on different sides of the biosensor, and the embodiments of this application do not limit this.

[0115] For example, taking the first working electrode and the second working electrode as being located on the same side of the biosensor, Figure 3 is a schematic diagram of the positions of the first working electrode and the second working electrode on the biosensor provided in the embodiment of this application.

[0116] Figure 3(a) and Figure 3(b) show two possible locations of the first and second working electrodes on the biosensor.

[0117] It should be understood that Figure 3(a) and Figure 3(b) only show schematic diagrams of one side of the biosensor. A reference electrode and a counter electrode can be provided on the other side of the biosensor. The embodiments of this application do not limit the placement of the reference electrode and the counter electrode.

[0118] As shown in Figure 3(a), region S in the biosensor is the area where the biosensor is implanted under the skin, and the first working electrode and the second working electrode are placed sequentially along the implantation direction.

[0119] As shown in Figure 3(b), region S in the biosensor is the area where the biosensor is implanted under the skin, and the first working electrode and the second working electrode are placed side by side along the implantation direction.

[0120] For example, the width of the biosensor in region S can be 200 μm to 500 μm, and the thickness can be 150 μm to 250 μm.

[0121] It should be noted that only the tip portions of the first and second working electrodes are shown in Figure 3(a) and Figure 3(b). The embodiments of this application do not restrict the placement of the first and second working electrodes in the portions not shown in Figure 3.

[0122] It is understood that in Figure 3(a), the first working electrode is located below the second working electrode. In other embodiments of this application, the positions of the first working electrode and the second working electrode can be interchanged, that is, the second working electrode is located below the first working electrode. Similarly, in Figure 3(b), the first working electrode is located to the left of the second working electrode. In other embodiments of this application, the positions of the first working electrode and the second working electrode can be interchanged, that is, the second working electrode is located to the left of the first working electrode.

[0123] For example, when fabricating a biosensor, insulating oil can be printed to ensure that the first working electrode and the second working electrode are mutually insulated during fabrication.

[0124] It is worth mentioning that, in addition to using an inactivating enzyme on the second working electrode, interference from interfering substances can also be eliminated by not using an enzyme at all. Specifically, by not using an enzyme on the second working electrode, it is possible to ensure that the second working electrode does not undergo an electrochemical reaction with the target analyte, and then the blood glucose concentration can be calculated by differential calculation of the current signals on the first and second working electrodes.

[0125] Preferably, an inactivating enzyme can be placed on the second working electrode. Compared to not placing an enzyme on the second working electrode, placing an inactivating enzyme on the second working electrode can ensure that the electron transfer efficiency of the electron transfer mediator on the second working electrode is consistent with the electron transfer efficiency of the electron transfer mediator on the first working electrode.

[0126] Electron transfer mediators are substances in biosensors that play a role in electron transfer. Since the active site of an enzyme is usually contained within the peptide chain of a protein, electrons are difficult to transfer directly to the electrode. Electron transfer mediators can be small molecules, polymers with redox functions in their main chain, or polymers with redox-active molecules branched onto their side links. They can establish a "bridge" between the enzyme's active site and the electrode, allowing electrons to be smoothly transferred to the electrode surface. Electron transfer mediators can be mixed with the enzyme; when the enzyme is placed on the working electrode, the electron transfer mediator can be placed on the working electrode simultaneously.

[0127] For example, the electron transfer mediator can be potassium ferrocyanide, ferrocene methanol, or other substances.

[0128] It is understood that, in the embodiments of this application, the electron transfer medium may also be referred to as an electron medium, an electron carrier, an electron transfer medium, etc., and the embodiments of this application do not limit the name.

[0129] By comparing the cyclic voltammetry curves obtained by the electrode with and without enzyme, it can be seen that the peak current value of the electrode with enzyme is lower than that without enzyme, and the trough current value with enzyme is higher than that without enzyme.

[0130] It is evident that the presence of enzymes (i.e., proteins) reduces the electron transfer efficiency of electron transfer mediators. In other words, if an enzyme is not placed on the second working electrode, the electron transfer efficiency of the electron transfer mediator on the second working electrode will be higher than that on the first working electrode. This will cause the response currents related to the electron transfer mediators on the first and second working electrodes to become inconsistent, thereby interfering with the measurement of the target analyte concentration.

[0131] For example, on the working electrode, interfering substances such as ascorbic acid can react with electron transfer mediators to generate an interfering current I. os Specifically, an electron transfer mediator placed on the working electrode can be reduced by interfering substances such as ascorbic acid in the user's body. Its reduced state is oxidized on the electrode surface, thereby generating an interfering current I. os .

[0132] The presence of enzymes reduces the electron transfer efficiency of electron transfer mediators, thus generating an interference current I on the working electrode with enzymes.os Less than the interference current I generated on the enzyme-free working electrode os .

[0133] It is evident that placing the same number of enzymes on the second working electrode as on the first working electrode can minimize the interference current I generated on both the first and second working electrodes. os Maintain consistency.

[0134] For example, at the working electrode, oxygen can react with the electron transfer mediator to generate an interfering current I. o2 Specifically, because oxygen reacts chemically with the electron transfer mediator on the working electrode, and oxygen is inevitably present in the body environment, after the working electrode is implanted subcutaneously, the electron transfer mediator on the working electrode will be oxidized by oxygen, generating an interfering current I. o2 .

[0135] The presence of enzymes reduces the electron transfer efficiency of electron transfer mediators, thus generating an interference current I on the working electrode with enzymes. o2 Less than the interference current I generated on the enzyme-free working electrode o2 .

[0136] It is evident that placing the same number of enzymes on the second working electrode as on the first working electrode can minimize the interference current I generated on both the first and second working electrodes. os Maintain consistency.

[0137] In practice, the first working electrode serves as the electrode for detecting the target analyte, and the second working electrode serves as the anti-interference electrode. Both the first and second working electrodes can have the same number of enzyme dots. These enzyme dots refer to the locations where glucose oxidase and electron transfer mediators are placed.

[0138] Assume that both the first and second working electrodes include N (N≥1) enzyme dots. On the first working electrode, some or all of the N enzyme dots can be used to place active enzymes, and on the second working electrode, some or all of the N enzyme dots can be used to place inactive enzymes. Furthermore, the first and second working electrodes can have the same number of electron transfer mediators placed on them. For example, electron transfer mediators can be placed on all N enzyme dots on both the first and second working electrodes.

[0139] In the following examples, an electron transfer mediator is placed on each enzyme spot of the first and second working electrodes. The placement of the electron transfer mediator on the enzyme spots of the first and second working electrodes will not be repeated below.

[0140] It should be understood that, apart from the enzyme itself, the materials and structures on the first and second working electrodes should be consistent. For example, the area of ​​the electrode substrate should be consistent to avoid introducing factors other than interfering substances that could interfere with the calculation of the target analyte concentration. Furthermore, the amount of enzyme placed on each enzyme spot can be the same, thus allowing control over the amount of enzyme placed on the electrode.

[0141] In one example, all enzyme spots on the first working electrode are used to place active enzymes, and all enzyme spots on the second working electrode are used to place inactive enzymes.

[0142] Figure 4 shows a schematic diagram of the first and second working electrodes after enzyme dots are set, using the first and second working electrodes shown in Figure 3(b) as an example.

[0143] As shown in Figure 4, on the first working electrode, N enzyme spots are used to place active enzymes, and on the second working electrode, N enzyme spots are used to place inactive enzymes.

[0144] The current I1 generated on the first working electrode can be expressed by the following formula 1: I1=N*(I bg +I g +I os -I o2 )+I ox Formula 1

[0145] Among them, I bg I represents the background current. g I represents the current generated when the target analyte reacts with the active enzyme at an enzyme spot to reduce the electron transfer mediator, and its reduced state is oxidized on the electrode surface. os I represents the current generated when the reduced state of the electron transfer mediator, such as ascorbic acid, is oxidized on the electrode surface after interferences reduce it. o2 I represents the response current lost due to oxygen oxidation of the electron transfer mediator. ox This indicates the current generated when interfering substances such as ascorbic acid are oxidized on the electrode surface.

[0146] It is important to note that in Formula 1, I bg I os I o2 All of these are related to electron transfer mediators, which are placed on N enzyme sites on the first working electrode. Therefore, the current I1 generated on the first working electrode contains N times the amount of I. bg I os I o2 Similarly, I gThis is related to the active enzyme, which is located at N enzyme sites on the first working electrode. Therefore, the current I1 generated on the first working electrode contains N times the amount of I. g , while I ox It is related to the electrode, but not to the number of enzyme spots. Therefore, in the current I1 generated on the first working electrode, I ox It is independent of the coefficient N. The current in the operating current mentioned later is similar and will not be repeated here.

[0147] The current I2 on the second working electrode can be expressed by the following formula 2: I2=N*(I bg +I os -I o2 )+I ox Formula 2

[0148] Specifically regarding I bg I os I o2 I ox For a description, please refer to Formula 1 above.

[0149] Combining Equations 1 and 2, we can see that I2 can be considered as the interference current, and I1 can be considered as the sum of the interference current and the current corresponding to the target analyte. Therefore, the differential signal ΔI between the current I1 on the first working electrode and the current I2 on the second working electrode is ΔI = I1 - I2 = N*I g This allows us to obtain the current generated by the reaction between the target analyte and the electrode after removing interference, and then calculate the concentration of the target analyte in the user's body based on this differential signal ΔI.

[0150] It should be noted that in the first and second working electrodes shown in Figure 4, multiple enzyme dots are arranged at intervals along the direction of the electrode. In other embodiments of this application, these enzyme dots may also present other arrangements. This application does not limit this. The first and second working electrodes mentioned in other examples are similar and will not be described again below.

[0151] In another example, a portion of the enzyme dots on the second working electrode is used to hold inactivating enzymes, while another portion is used to hold active enzymes. In this way, the active enzymes on the second working electrode can also chemically react with the target analyte in the user's body. By comparing the response currents related to the target analyte on the first and second working electrodes, it is possible to identify whether the biosensor exhibits early attenuation or late failure after subcutaneous implantation.

[0152] Taking a glucose sensor as an example, early sensitivity attenuation (ESA) refers to the decrease or attenuation of the glucose sensor's sensitivity within a predetermined period after implantation, such as the first 12-24 hours. Typically, early attenuation is caused by bleeding at the implantation site after implantation, leading to red blood cell aggregation and glucose consumption. This results in a temporary decrease in the glucose-related current signal detected by the sensor. As the red blood cells gradually die, the early attenuation phenomenon gradually disappears.

[0153] Taking glucose sensors as an example, late sensor attenuation (LSA) refers to the premature end of a glucose sensor's lifespan due to immune responses, inflammation, fibrosis, or vascular degeneration, occurring 12-24 hours before the sensor's intended use. Typically, LSA is associated with severe implantation injury; the more severe the bleeding during implantation, the greater the likelihood of premature sensor failure, i.e., the greater the possibility of LSA. Because implantation trauma causes bleeding at the implantation site, red blood cells accumulate and die around the sensor, leading to macrophage aggregation and glucose consumption. This results in a decrease in glucose concentration around the implantation site, causing a drop in the glucose-related current signal acquired by the sensor, and the LSA is irreversible.

[0154] It should be noted that early attenuation can also be referred to as early sensitivity attenuation, early sensitivity reduction, etc., and late failure can also be referred to as sensor lifespan termination, late sensor attenuation, etc. The embodiments of this application do not limit the names of early attenuation and late failure.

[0155] Figure 5 shows another schematic diagram of the first and second working electrodes after the enzyme spots are set, using the first and second working electrodes shown in Figure 3(b) as an example.

[0156] As shown in Figure 5, on the first working electrode, N enzyme spots are used to place active enzymes. On the second working electrode, of the N enzyme spots, X enzyme spots are used to place active enzymes, and (NX) enzyme spots are used to place inactive enzymes.

[0157] Therefore, the current I1 on the first working electrode can be expressed by the following formula 3:

[0158] Among them, I gi This represents the current generated when the target analyte reacts with the active enzyme at the i-th enzyme spot on the first working electrode to reduce the electron transfer mediator, and its reduced state is oxidized on the electrode surface. The remaining currents are related to I.bg I os I o2 I ox For a description, please refer to Formula 1 above.

[0159] In addition, the current I2 on the second working electrode can be expressed by the following formula 4:

[0160] Among them, I gj This represents the current generated when the target analyte reacts with the active enzyme at the j-th enzyme spot on the second working electrode to reduce the electron transfer mediator, and its reduced state is oxidized on the electrode surface. The remaining currents are related to I. bg I os I o2 I ox For a description, please refer to Formula 1 above.

[0161] Combining formulas 1 and 3, it can be seen that the current I1 on the first working electrode and the current I2 on the second working electrode both include the interference current (N*(I bg +I os -I o2 )+I ox The current associated with the target analyte.

[0162] Furthermore, if the biosensor does not experience early attenuation or late failure after subcutaneous implantation, the concentration of the target analyte around the first and second working electrodes should be consistent. Therefore, the current generated at each enzyme point containing an active enzyme on the first and second working electrodes should be equal.

[0163] In other words, in Formula 3, In Formula 4, Among them, I g This represents the current generated when the target analyte reacts with the active enzyme at an enzyme spot to reduce the electron transfer mediator, and its reduced state is oxidized on the electrode surface.

[0164] Therefore, the differential signal ΔI = I1 - I2 = (NX) * I through the current I1 on the first working electrode and the current I2 on the second working electrode g Even after removing interference, the current generated by the reaction between the target analyte and the electrode can still be obtained, and then based on... This allows us to calculate the concentration of the target analyte in the user's body.

[0165] Furthermore, if the biosensor experiences early attenuation or late failure after subcutaneous implantation, the concentration of the target analyte around the first and second working electrodes will change. The concentration of the target analyte around different enzyme points may be different. Therefore, the current generated at each enzyme point with an active enzyme on the first and second working electrodes may be different.

[0166] Furthermore, by combining formulas 3 and 4, we can derive the following formula 5:

[0167] If the biosensor does not experience early attenuation or late failure after subcutaneous implantation, then Then, in formula 5 Correspondingly, if the glucose sensor experiences early attenuation or late failure after subcutaneous implantation, then Then, in formula 5

[0168] Therefore, it can be identified The changes in these changes can be used to determine whether the glucose sensor has experienced early degradation or late failure.

[0169] In one implementation, the first working electrode can be positioned on the side away from the tip of the hard needle, and the second working electrode can be positioned on the side closer to the tip of the hard needle. Furthermore, the active enzyme on the second working electrode can be positioned at an enzyme point near the tip of the hard needle. The hard needle is used to puncture the skin when the soft needle of the biosensor needs to be implanted subcutaneously, thereby driving the soft needle portion of the biosensor into the subcutaneous tissue.

[0170] Typically, after the biosensor is implanted subcutaneously, the hard needle will bounce away from the subcutaneous tissue. Therefore, the relative positional relationship between the first and second working electrodes mentioned above and the hard needle can be used to describe the relative positional relationship when the biosensor is implanted subcutaneously along with the hard needle.

[0171] For example, Figure 6 shows a schematic diagram of the relative positions of the first working electrode and the second working electrode with the hard needle when the glucose sensor is implanted subcutaneously with the hard needle.

[0172] As shown in Figure 6, when the glucose sensor is implanted subcutaneously, the tip of the glucose sensor, where the first and second working electrodes are located, is wrapped with a rigid needle and implanted subcutaneously along with the needle. After the tip of the glucose sensor is implanted, the rigid needle bounces back out of the subcutaneous tissue. If the glucose sensor experiences early attenuation or late failure, the implantation of the rigid needle will cause more red blood cells to accumulate and a lower glucose concentration to occur on the side of the subcutaneous tissue closer to the needle tip. Furthermore, around the glucose sensor, the closer to the needle tip, the more red blood cells accumulate and the less glucose is present.

[0173] Therefore, placing the second working electrode on the side closer to the tip of the hard needle makes it easier to identify whether the biosensor has experienced early decay or late failure. At the same time, it can also reduce the impact of early decay or late failure on the first working electrode, ensuring the accuracy of the first working electrode in identifying the concentration of the target analyte in vivo.

[0174] In the relative positional relationship shown in Figure 6, if the biosensor experiences early attenuation or late failure, the concentration of the target analyte near the active enzyme on the second working electrode will be lower than the concentration of the target analyte near the active enzyme on the first working electrode, thus affecting the expression in Formula 5. Then assume N*(I) bg +I os -I o2 )+I ox If ≈0, then it can be identified Whether the value is less than 0 is used to determine whether the glucose sensor has experienced early decay or late failure.

[0175] Specifically, if If the early degradation or late failure is detected, the biosensor is considered to have exhibited either early degradation or late failure; otherwise, the biosensor is considered not to have exhibited either early degradation or late failure.

[0176] Furthermore, by combining the timing of early decay and late failure, if... At this stage, during the initial implantation phase of the biosensor, it can be considered that the biosensor is experiencing early degradation. If it detects... If the biosensor is in the late stage of implantation, it can be considered that the biosensor has experienced late failure.

[0177] In some implementations, if the biosensor does not exhibit early degradation or late failure, it can be based on To calculate the concentration of the target analyte in the user's body, if the biosensor exhibits early decay or late failure, the concentration of the target analyte in the user's body can be calculated based on I1, avoiding the introduction of the second operating current I2, which is affected by early decay or late failure, to further interfere with the calculation of the target analyte concentration.

[0178] To better understand the above, a specific example is used below to describe the identification of early decay and late failure of a glucose sensor.

[0179] Figure 7 is a schematic diagram of a first working electrode and a second working electrode provided in an embodiment of this application.

[0180] As shown in Figure 7, the first working electrode is located on the side away from the tip of the hard needle, and the second working electrode is located on the side closer to the tip of the hard needle. It is assumed that there are 6 enzyme dots on both the first and second working electrodes. The 6 enzyme dots on the first working electrode are used to set active enzymes, i.e., active glucose oxidase. The 3 enzyme dots on the second working electrode closer to the tip of the hard needle are used to set active enzymes, i.e., active glucose oxidase. The 3 enzyme dots on the second working electrode away from the tip of the hard needle are used to set inactive enzymes, i.e. inactive glucose oxidase.

[0181] If the current generated on the first working electrode is I1 and the current generated on the second working electrode is I2, it can be determined whether the glucose sensor has experienced early decay or late failure by identifying whether 2I2-I1 is less than 0. Furthermore, if the glucose sensor has not experienced early decay or late failure, the user's blood glucose concentration can be calculated based on 2(I1-I2). If the glucose sensor has experienced early decay or late failure, the user's blood glucose concentration can be calculated based on I1.

[0182] Furthermore, a portion of the enzyme dots on the first working electrode can be used to place inactivating enzymes. This is because even if the first working electrode is positioned away from the hard needle tip, early decay or late failure will still affect the concentration of the target analyte around the first working electrode, particularly the current signal generated by the enzyme dots near the hard needle tip that react with the target analyte. Therefore, inactivating enzymes can be placed on the enzyme dots near the hard needle tip of the first working electrode to minimize the impact of early decay or late failure on the current signal detected by the first working electrode.

[0183] Figure 8 shows another schematic diagram of the first and second working electrodes after enzyme dots are set, using the first and second working electrodes shown in Figure 3(b) as examples.

[0184] As shown in Figure 8, both the first and second working electrodes are provided with N enzyme dots. On the first working electrode, Y enzyme dots are used to set active enzymes and (NY) enzyme dots are used to set inactive enzymes. On the second working electrode, X enzyme dots are used to set active enzymes and (NX) enzyme dots are used to set inactive enzymes.

[0185] Therefore, the current I1 on the first working electrode can be expressed by the following formula 6:

[0186] The current I2 on the second working electrode can be expressed by the above formula 4.

[0187] Combining formulas 4 and 6, it can be seen that the current I1 on the first working electrode and the current I2 on the second working electrode both include the interference current (N*(Ibg +I os -I o2 )+I ox The current associated with the target analyte.

[0188] Furthermore, if the biosensor does not experience early attenuation or late failure after subcutaneous implantation, the concentration of the target analyte around the first and second working electrodes will be consistent. Therefore, in Equation 4, In Formula 6, I g This represents the current generated when the target analyte reacts with the active enzyme at an enzyme spot to reduce the electron transfer mediator, and its reduced state is oxidized on the electrode surface.

[0189] Therefore, if the biosensor does not experience early attenuation or late failure after subcutaneous implantation, the differential signal ΔI between the current I1 on the first working electrode and the current I2 on the second working electrode will be: ΔI = I1 - I2 = (YX) * I g Even after removing interference, the current generated by the reaction between the target analyte and the electrode can still be obtained, and then based on... This allows us to calculate the concentration of the target analyte in the user's body.

[0190] Furthermore, if the biosensor experiences early attenuation or late failure after subcutaneous implantation, the concentration of the target analyte on the first working electrode and around the second working electrode will change. The concentration of the target analyte around different enzyme points may be different. Therefore, the current generated at each enzyme point with an active enzyme on the first and second working electrodes may be different.

[0191] Furthermore, by combining formulas 4 and 6, we can derive the following formula 7:

[0192] If the biosensor does not experience early attenuation or late failure after subcutaneous implantation, then If the biosensor experiences early attenuation or late failure after subcutaneous implantation, then

[0193] Therefore, it can be identified Changes in these changes can be used to determine whether a biosensor has experienced early degradation or late failure.

[0194] In one implementation, the first working electrode can be disposed on the side away from the tip of the hard needle, and the second working electrode can be disposed on the side close to the tip of the hard needle. Furthermore, the active enzyme on the first working electrode can be disposed on an enzyme point away from the tip of the hard needle, and the inactivating enzyme on the first working electrode can be disposed on an enzyme point close to the tip of the hard needle. The active enzyme on the second working electrode can be disposed on an enzyme point close to the tip of the hard needle, and the inactivating enzyme on the second working electrode can be disposed on an enzyme point away from the tip of the hard needle.

[0195] Therefore, considering the environmental changes at the implantation site after the glucose sensor experiences early attenuation or late failure as shown in Figure 6, it can be seen that if the biosensor experiences early attenuation or late failure, the concentration of the target analyte near the active enzyme on the second working electrode is lower than the concentration of the target analyte near the active enzyme on the first working electrode, resulting in the situation described in Formula 7. Then assume N*(I) bg +I os -I o2 )+I ox If ≈0, then it can be identified Whether the value is less than 0 is used to determine whether the biosensor has experienced early degradation or late failure.

[0196] Specifically, if If the early degradation or late failure is detected, the biosensor is considered to have exhibited either early degradation or late failure; otherwise, the biosensor is considered not to have exhibited either early degradation or late failure.

[0197] Furthermore, by combining the timing of early decay and late failure, if... At this stage, during the initial implantation phase of the biosensor, it can be considered that the biosensor is experiencing early degradation. If it detects... If the biosensor is in the late stage of implantation, it can be considered that the biosensor has experienced late failure.

[0198] In some implementations, if the biosensor does not exhibit early degradation or late failure, it can be based on To calculate the concentration of the target analyte in the user's body, if the biosensor exhibits early degradation or late failure, it can be based on... To calculate the concentration of the target analyte in the user's body, the current I2 of the second operating current, which is affected by early decay or late failure, is avoided from further interfering with the calculation of the target analyte concentration.

[0199] To better understand the above, a specific example is used below to describe the identification of early decay and late failure of a glucose sensor.

[0200] Figure 9 is a schematic diagram of another first working electrode and a second working electrode provided in an embodiment of this application.

[0201] As shown in Figure 9, the first working electrode is located on the side away from the tip of the hard needle, and the second working electrode is located on the side closer to the tip of the hard needle. Assume that there are 6 enzyme dots on both the first and second working electrodes. Specifically, the two enzyme dots on the first working electrode closer to the tip of the hard needle contain inactive glucose oxidase, and the four enzyme dots on the first working electrode away from the tip of the hard needle contain active glucose oxidase. The two enzyme dots on the second working electrode closer to the tip of the hard needle contain active glucose oxidase, and the four enzyme dots on the second working electrode away from the tip of the hard needle contain inactive glucose oxidase.

[0202] So, if the current on the first working electrode is I1 and the current on the second working electrode is I2, we can determine whether the glucose sensor has experienced early attenuation or late failure by identifying whether 2I2-I1 is less than 0. Furthermore, if the glucose sensor has not experienced early attenuation or late failure, the user's blood glucose concentration can be calculated based on 3(I1-I2). If the glucose sensor has experienced early attenuation or late failure, it can be calculated based on... To calculate the user's blood glucose concentration.

[0203] The aforementioned biosensor can be used in device 100, which can analyze the concentration of the target analyte in the user's body based on the current signal generated by the biosensor after it is implanted under the skin.

[0204] For example, Figure 10 is a schematic flowchart of a method for detecting the concentration of a target analyte provided in an embodiment of this application.

[0205] As shown in Figure 10, the method may include:

[0206] S101. The device 100 acquires the first current generated after the first working electrode is implanted subcutaneously.

[0207] The device 100 may include a biosensor and a processor. The biosensor may be any of the biosensors mentioned in the examples above, and the processor may be used to process the current generated by the biosensor and determine the concentration of the target analyte in the user's body based on the current.

[0208] In practical use, users can wear the device 100 on their body, such as the upper arm or abdomen, so that a part of the biosensor is implanted under the skin, thereby generating an electric current signal through an electrochemical reaction with the target analyte at the implantation site. The electronic device processes the electric current signal through a processor to calculate the concentration of the target analyte in the user's body.

[0209] The first working electrode may include a first enzyme spot, which is provided with an active enzyme. For example, if the biosensor is a glucose sensor, then the active enzyme is an active glucose oxidase.

[0210] The first current may include: the current generated by the reaction of the target analyte with the active enzyme, and the current generated by the reaction of the interfering substance with the first working electrode.

[0211] S102. The device 100 acquires the second current generated after the second working electrode is implanted subcutaneously.

[0212] The second working electrode may include a second enzyme spot, which is equipped with an inactivating enzyme. For example, if the biosensor is a glucose sensor, the inactivating enzyme is an inactive glucose oxidase.

[0213] The second current may include the current generated by the reaction between the interfering substance and the second working electrode.

[0214] In some embodiments, device 100 may further include a hard needle. As the hard needle is implanted subcutaneously at the tip of the biosensor, the second working electrode is positioned closer to the tip of the hard needle than the first working electrode. This is because bleeding is more likely to occur around the tip of the hard needle as it pierces the skin, leading to a significant difference between the concentration of the target analyte in the implanted environment and the actual concentration of the target analyte in the user's body. Positioning the first working electrode as far away from the tip as possible minimizes the impact of early attenuation or late failure on the first working electrode, while simultaneously improving the sensitivity of the second working electrode in detecting early attenuation or late failure.

[0215] In some embodiments, the first working electrode and the second working electrode may be placed side by side along the implantation direction, or the first working electrode and the second working electrode may be placed sequentially along the implantation direction.

[0216] It is understood that the embodiments of this application do not limit the execution order of steps S101 and S102. For example, device 100 may execute step S101 first and then step S102, so that device 100 may obtain the first current first and then the second current. Or, device 100 may execute step S102 first and then step S101, so that device 100 may obtain the second current first and then the first current. Or, device 100 may execute steps S101 and S102 simultaneously, so that device 100 may obtain the first current and the second current simultaneously.

[0217] S103. The device 100 determines the concentration of the target analyte in the user's body based on the first current and the second current, or determines a third current based on the first current and the second current, and sends the third current to the electronic device 200, wherein the third current is related to the concentration of the target analyte in the user's body.

[0218] For example, device 100 may determine the third current via a processor. Referring to FIG2, the processor may include other devices besides the reference electrode, counter electrode, first working electrode, and second working electrode.

[0219] Specifically, the device 100 determines the concentration of the target analyte in the user's body based on the first current and the second current. More specifically, the device 100 determines the third current based on the first current and the second current, and then determines the concentration of the target analyte in the user's body based on the third current.

[0220] For example, the device 100 can determine the concentration of the target analyte in the user's body by means of a third current, based on the mapping relationship between the current and the concentration of the target analyte.

[0221] In one implementation, the first working electrode may include N first enzyme spots, and the second working electrode may include N second enzyme spots, where N ≥ 1.

[0222] In this case, the device 100 can determine the concentration of the target analyte in the user's body based on the difference between the first current and the second current, or the third current can refer to the difference between the first current and the second current.

[0223] In another implementation, the second working electrode also includes a first enzyme dot. Thus, the second current generated by the second working electrode after subcutaneous implantation also includes the current generated by the reaction between the target analyte and the active enzyme.

[0224] In this case, the device 100 can still determine the concentration of the target analyte in the user's body based on the difference between the first current and the second current, or the third current can refer to the difference between the first current and the second current.

[0225] Furthermore, the device 100 can identify early decay or late failure of the biosensor based on the first current and the second current, and then determine which current to use to determine the concentration of the target analyte in the user's body based on whether the biosensor exhibits early decay or late failure.

[0226] For example, if device 100 detects early degradation or late failure of the biosensor, device 100 can determine the concentration of the target analyte in the user's body based on a first current and a second current. Otherwise, device 100 can determine the concentration of the target analyte in the user's body based on the first current.

[0227] Furthermore, the device 100 can also determine whether the phenomenon observed by the biosensor is early attenuation or late failure by combining the implantation time of the biosensor.

[0228] In one example, it is assumed that the first working electrode may include N first enzyme spots, and the second working electrode may include X first enzyme spots and (NX) second enzyme spots, where N≥2 and X≥1.

[0229] In this case, the third current can refer to Where I1 represents the first current and I2 represents the second current. That is, device 100 can be based on... To determine the concentration of the target analyte in the user's body.

[0230] Furthermore, if the second working electrode is closer to the tip of the needle than the first working electrode when the biosensor's tip is implanted subcutaneously with the hard needle, then early degradation or late failure of the biosensor can be further identified based on N, X, the first current, and the second current. Specifically, calculations can be performed. based on Whether the value is less than 0 can be used to distinguish whether the biosensor has experienced early degradation or late failure.

[0231] Specifically, in In this case, the biosensor did not exhibit early degradation or late failure; the third current can refer to... That is, device 100 can be based on Determine the concentration of the target analyte in the user's body, in In cases where the biosensor exhibits early decay or late failure, the third current can refer to I1, meaning that the device 100 can determine the concentration of the target analyte in the user's body based on I1.

[0232] Additionally, when device 100 detects early degradation or late failure of the biosensor, that is... In such cases, device 100 can output first information, which can be used to indicate that the biosensor has experienced early decay or late failure.

[0233] The first information can be an instruction output by the processor in device 100. When the processor outputs the first information, device 100 can output a prompt message, which can be used to remind the user that the biosensor has experienced early degradation or late failure. Alternatively, if device 100 is connected to other devices, such as electronic device 200, device 100 can also send the first information to the other devices so that the other devices can determine the implantation status of device 100 based on the first information.

[0234] Furthermore, in In such cases, the implantation time of the biosensor can also be used to identify whether the biosensor has experienced early degradation or late failure.

[0235] Among them, if Furthermore, if the biosensor is implanted under the skin within a preset time period, the first information is used to indicate that the biosensor has experienced early degradation; if Furthermore, if the biosensor is within a preset time period before failure, the first information is used to indicate that the biosensor has experienced late failure.

[0236] It should be understood that, since the electrode tip of the biosensor is close to the needle tip when it is implanted subcutaneously with the hard needle, the X first enzyme points on the second working electrode being close to the electrode tip can also be understood as the X first enzyme points on the second working electrode being close to the needle tip when the tip of the biosensor is implanted subcutaneously with the hard needle. Similarly, the (NX) second enzyme points on the second working electrode being far from the electrode tip can also be understood as the (NX) second enzyme points on the second working electrode being far from the needle tip when the tip of the biosensor is implanted subcutaneously with the hard needle. Here, the electrode tip refers to the end of the electrode that first contacts the skin at the implantation site during the implantation process with the biosensor. Subsequent descriptions of the relative positions of the enzyme points and the electrode tip are similar and will not be repeated below.

[0237] In another example, suppose the first working electrode may include Y first enzyme spots and (NY) second enzyme spots, and the second working electrode may include X first enzyme spots and (NX) second enzyme spots, where N≥2, X≥1, and Y≥1.

[0238] In this case, the third current can refer to Where I1 represents the first current and I2 represents the second current. That is, device 100 can be based on... To determine the concentration of the target analyte in the user's body.

[0239] Furthermore, in the design of the first working electrode and the second working electrode, the Y first enzyme dots on the first working electrode can be far away from the electrode tip of the first working electrode, and the (NY) second enzyme dots can be close to the electrode tip of the first working electrode. In addition, the X first enzyme dots on the second working electrode can be close to the electrode tip of the second working electrode, and the (NX) second enzyme dots can be far away from the electrode tip of the second working electrode.

[0240] This reduces the impact of early decay and late failure on the first working electrode and improves the sensitivity of the second working electrode in identifying early decay and late failure.

[0241] Furthermore, if the second working electrode is closer to the tip of the needle than the first working electrode when the biosensor's tip is implanted subcutaneously with the hard needle, then early degradation or late failure of the biosensor can be further identified based on X, Y, the first current, and the second current. Specifically, calculations can be performed. based on Whether the value is less than 0 can be used to distinguish whether the biosensor has experienced early degradation or late failure.

[0242] Specifically, in In this case, the biosensor did not exhibit early degradation or late failure; the third current can refer to... That is, device 100 can be based on Determine the concentration of the target analyte in the user's body, in In cases where biosensors exhibit early degradation or late failure, the third current can refer to... That is, device 100 can be based on Determine the concentration of the target analyte in the user's body.

[0243] Additionally, when device 100 detects early degradation or late failure of the biosensor, that is... In such cases, device 100 can output second information, which can be used to indicate that the biosensor has experienced early decay or late failure.

[0244] The second information can be an instruction output by the processor in device 100. When the processor outputs this second information, device 100 can output a prompt message, which can be used to remind the user that the biosensor has experienced early degradation or late failure. Alternatively, if device 100 is connected to other devices, such as electronic device 200, device 100 can also send the second information to the other devices so that the other devices can determine the implantation status of device 100 based on the second information.

[0245] Furthermore, in In such cases, the implantation time of the biosensor can also be used to identify whether the biosensor has experienced early degradation or late failure.

[0246] Among them, if Furthermore, if the biosensor is implanted under the skin within a preset time period, the second information is used to indicate that the biosensor has experienced early degradation; if Furthermore, if the biosensor is within a preset time period before failure, the second information is used to indicate that the biosensor has experienced late failure.

[0247] In some embodiments, if the device 100 includes an output module such as a display screen or an audio module, it can directly output the calculated concentration of the target analyte in the user's body so that the user can understand the status of the target analyte in the body.

[0248] Additionally, device 100 can also send a third current to other devices, such as electronic device 200, to analyze the concentration of the target analyte in the user's body. In this way, the user can also view the concentration of the target analyte in their body through other devices.

[0249] For example, the electronic device 200 can be a mobile phone, watch, bracelet, tablet, computer, or other device, and the device 100 and the electronic device 200 can establish a communication connection, such as a Bluetooth connection.

[0250] As can be seen from steps S101-S103, the device 100 can be equipped with a biosensor. By collecting the current signal generated by the biosensor after it is implanted under the skin, the concentration of the target analyte in the user's body can be calculated.

[0251] Figure 11 is a schematic diagram of the structure of the device 100 provided in the embodiment of this application.

[0252] As shown in Figure 11, the device 100 may include components such as a processor 101, a memory 102, and a communication module 103. These components can be connected via a bus 104 or other means. Figure 10 illustrates a bus connection as an example, where the bus 104 is used to enable communication between the processor 101, the memory 102, and the communication module 103.

[0253] The processor 101 may include one or more processing units. The processor 101 can be used to provide computing and control capabilities to support the operation of the entire device 100.

[0254] The memory 102 can be used to store various software programs and / or multiple sets of instructions. Specifically, the memory 102 may include high-speed random access memory, and may also include non-volatile memory, such as one or more disk storage devices, flash memory devices, or other non-volatile solid-state storage devices.

[0255] The communication module 103 can be used to communicate with other communication devices. Specifically, the communication module 103 may include a communication interface, which may be a 3G communication interface, a Long Term Evolution (LTE) (4G) communication interface, a 5G communication interface, a WLAN communication interface, a WAN communication interface, a human skin communication interface, etc. Not limited to wireless communication interfaces, the device 100 can also be configured with a wired communication interface to support wired communication.

[0256] In this embodiment, processor 101 can be used to acquire a first current generated after the first working electrode is implanted subcutaneously, and to acquire a second current generated after the second working electrode is implanted subcutaneously. Based on the first current and the second current, processor 101 can determine the concentration of the target analyte in the user's body, or, based on the first current and the second current, processor 101 can determine a third current, which is related to the concentration of the target analyte in the user's body. Communication module 103 can be used to send the concentration value of the target analyte in the user's body determined by the third current or the first current and the second current to other devices. Memory 102 can be used to store the current generated by the first working electrode and the second working electrode, as well as the software or program code required for all or part of the functions of device 100 in the above method embodiment.

[0257] It should be noted that the device 100 shown in FIG11 is only one implementation of the embodiment of this application. In actual applications, the device 100 may include more or fewer components than shown in the figure, or combine some components, or deploy different components. No limitation is made here.

[0258] It should be understood that each step in the above method embodiments can be completed by integrated logic circuits in the processor hardware or by instructions in software form. The method steps disclosed in the embodiments of this application can be directly manifested as being executed by a hardware processor, or being executed by a combination of hardware and software modules in the processor.

[0259] This application also provides an electronic device that may include a memory, a processor, and a computer program stored in the memory, wherein the processor executes the computer program to implement the method performed by the electronic device as described in any of the above embodiments.

[0260] This application also provides a chip system including a processing circuit and an interface circuit. The interface circuit is used to receive computer instructions and transmit them to the processing circuit. The processing circuit is used to execute the computer instructions to implement the method performed by the electronic device as in any of the above embodiments.

[0261] This application also provides a chip system including at least one processor for implementing the methods executed by the electronic device in any of the above embodiments. In one possible design, the chip system further includes a memory for storing program instructions and data, the memory being located within or outside the processor.

[0262] A chip system can consist of chips or include chips and other discrete components.

[0263] Optionally, there may be one or more processors in the chip system. The processor can be implemented in hardware or software. When implemented in hardware, the processor can be a logic circuit, integrated circuit, etc. When implemented in software, the processor can be a general-purpose processor, implemented by reading software code stored in memory.

[0264] Optionally, the chip system may contain one or more memories. These memories may be integrated with the processor or disposed separately; this application does not limit this. For example, the memory may be a non-transient processor, such as a read-only memory (ROM), which may be integrated with the processor on the same chip or disposed on different chips. This application does not specifically limit the type of memory or the arrangement of the memory and processor.

[0265] For example, the chip system may be a field programmable gate array (FPGA), an application specific integrated circuit (ASIC), a system on chip (SoC), a central processor unit (CPU), a network processor (NP), a digital signal processor (DSP), a micro controller unit (MCU), a programmable logic device (PLD), or other integrated chips.

[0266] This application also provides a computer-readable storage medium having a computer program stored thereon, which, when executed by a processor, implements the method executed by the electronic device in any of the above embodiments.

[0267] This application also provides a computer program product, including a computer program that, when executed by a processor, implements the method executed by the electronic device as described in any of the above embodiments.

[0268] The various embodiments of this application can be combined arbitrarily to achieve different technical effects.

[0269] In the above embodiments, implementation can be achieved, in whole or in part, through software, hardware, firmware, or any combination thereof. When implemented in software, it can be implemented, in whole or in part, as a computer program product. The computer program product includes one or more computer instructions. When the computer program instructions are loaded and executed on a computer, all or part of the processes or functions described in this application are generated. The computer can be a general-purpose computer, a special-purpose computer, a computer network, or other programmable device. The computer instructions can be stored in a computer-readable storage medium or transmitted from one computer-readable storage medium to another. For example, the computer instructions can be transmitted from one website, computer, server, or data center to another website, computer, server, or data center via wired (e.g., coaxial cable, fiber optic, digital subscriber line) or wireless (e.g., infrared, wireless, microwave, etc.) means. The computer-readable storage medium can be any available medium accessible to a computer or a data storage device such as a server or data center that integrates one or more available media. The available medium can be a magnetic medium (e.g., floppy disk, hard disk, magnetic tape), an optical medium (e.g., DVD), or a semiconductor medium (e.g., solid-state disk (SSD)).

[0270] Those skilled in the art will understand that all or part of the processes in the methods of the above embodiments can be implemented by a computer program instructing related hardware. This program can be stored in a computer-readable storage medium, and when executed, it can include the processes described in the above method embodiments. The aforementioned storage medium includes various media capable of storing program code, such as ROM or random access memory (RAM), magnetic disks, or optical disks.

[0271] In the description of the embodiments of this application, unless otherwise stated, " / " means "or". For example, A / B can mean A or B. The "and / or" in the text is merely a description of the relationship between related objects, indicating that there can be three relationships. For example, A and / or B can mean: A exists alone, A and B exist simultaneously, and B exists alone. In addition, in the description of the embodiments of this application, "multiple" means two or more.

[0272] The terms "first" and "second" are used for descriptive purposes only and should not be construed as implying or suggesting relative importance or implicitly indicating the number of indicated technical features. Therefore, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of the embodiments of this application, unless otherwise stated, "multiple" means two or more.

[0273] In summary, the above description is merely an embodiment of the technical solution of this application and is not intended to limit the scope of protection of this application. Any modifications, equivalent substitutions, improvements, etc., made based on the disclosure of this application should be included within the scope of protection of this application.

Claims

1. A biosensor, characterized by, The biosensor includes a first working electrode and a second working electrode, wherein when the tip of the biosensor is implanted subcutaneously with a hard needle, the second working electrode is closer to the tip of the hard needle than the first working electrode. The first working electrode includes a first enzyme dot, which is provided with an active enzyme. After the first working electrode is implanted under the skin, it generates a first current. The first current includes: the current generated by the reaction of the target analyte with the active enzyme, and the current generated by the reaction of the interfering substance with the first working electrode. The second working electrode includes a second enzyme dot, which is provided with an inactivating enzyme. After the second working electrode is implanted subcutaneously, it generates a second current, which includes the current generated by the reaction between the interfering substance and the second working electrode.

2. The biosensor of claim 1, wherein, The first working electrode and the second working electrode are placed side by side along the implantation direction, or the first working electrode and the second working electrode are placed sequentially along the implantation direction.

3. The biosensor according to claim 1 or 2, characterized in that, The first working electrode includes N first enzyme spots, and the second working electrode includes N second enzyme spots, where N ≥ 1.

4. The biosensor according to any one of claims 1 to 3, wherein The second working electrode also includes the second enzyme spot, and the second current also includes the current generated by the reaction between the target analyte and the active enzyme; the first current and the second current are used to identify early decay or late failure of the biosensor.

5. The biosensor according to any one of claims 1 to 4, wherein The first working electrode includes N first enzyme spots, and the second working electrode includes X first enzyme spots and (NX) second enzyme spots, where N≥2 and X≥1.

6. The biosensor of claim 5, wherein, The X first enzyme spots are close to the electrode tip of the second working electrode, and the (NX) second enzyme spots are far from the electrode tip of the second working electrode.

7. The biosensor according to any one of claims 1 to 6, wherein The first working electrode includes Y first enzyme spots and (NY) second enzyme spots, and the second working electrode includes X first enzyme spots and (NX) second enzyme spots, wherein N≥2, X≥1, and Y≥1.

8. The biosensor according to claim 7, characterized in that, The Y first enzyme spots are far from the electrode tip of the first working electrode, and the (NY) second enzyme spots are close to the electrode tip of the first working electrode; The X first enzyme spots are close to the electrode tip of the second working electrode, and the (NX) second enzyme spots are far from the electrode tip of the second working electrode.

9. The biosensor according to any one of claims 1 to 8, wherein, The enzyme is glucose oxidase, and the target analyte is glucose.

10. An apparatus, comprising: The device includes: a biosensor, and a processor; The biosensor is a biosensor as described in any one of claims 1-9, the processor is connected to the first working electrode and the second working electrode respectively, and the processor is configured to determine the concentration of the target analyte in the user's body based on the first current and the second current, or to determine a third current based on the first current and the second current, and send the third current to the first device, wherein the third current is related to the concentration of the target analyte in the user's body.

11. The apparatus of claim 10, wherein, The biosensor is the biosensor as described in any one of claims 3-9, and the processor is configured to determine the concentration of the target analyte in the user's body based on the difference between the first current and the second current, or the third current is the difference between the first current and the second current.

12. The apparatus of claim 10, wherein, The biosensor is the biosensor as described in claim 4, and the processor is further configured to identify early decay or late failure of the biosensor based on the first current and the second current. If the processor detects that the biosensor has experienced early degradation or late failure, the processor is configured to determine the concentration of the target analyte in the user's body based on the first current and the second current, or the third current is determined based on the first current and the second current. If the processor detects that the biosensor has not experienced early decay or late failure, the processor is used to determine the concentration of the target analyte in the user's body based on the first current, or the third current is determined based on the first current.

13. The apparatus of claim 10, wherein, The biosensor is the biosensor as described in claim 5 or 6, and the processor is further configured to identify early decay or late failure of the biosensor based on N, X, the first current and the second current. If the processor detects that the biosensor has experienced early degradation or late failure, the processor is configured to determine the concentration of the target analyte in the user's body based on the first current and the second current, or the third current is determined based on the first current and the second current. If the processor detects that the biosensor has not shown signs of early decay or late failure, the processor is used to determine the concentration of the target analyte in the user's body based on the first current, or the third current is the first current.

14. The apparatus of claim 10, wherein, The biosensor is the biosensor as described in claim 7 or 8, and the processor is further configured to identify early decay or late failure of the biosensor based on X, Y, the first current and the second current. If the processor detects that the biosensor has experienced early degradation or late failure, the processor is configured to determine the concentration of the target analyte in the user's body based on the first current and the second current, or the third current is determined based on the first current and the second current. If the processor detects that the biosensor has not experienced early decay or late failure, the processor is used to determine the concentration of the target analyte in the user's body based on the first current, or the third current is determined based on the first current.

15. The apparatus according to any one of claims 12-14, characterized in that, If the processor detects that the biosensor has experienced early degradation or late failure, the processor is further configured to output first information, which indicates that the biosensor has experienced early degradation or late failure.

16. The apparatus according to any one of claims 12-15, characterized in that, If the processor detects that the biosensor has experienced early attenuation or late failure, the processor is further configured to identify whether the phenomenon is early attenuation or late failure based on the implantation time of the biosensor.

17. A method for detecting the concentration of a target analyte, characterized in that, The method is applied to an apparatus, the apparatus being the apparatus as described in any one of claims 10-16, and the method comprises: Acquire the first current generated after the first working electrode is implanted subcutaneously; Acquire the second current generated after the second working electrode is implanted subcutaneously; The concentration of the target analyte in the user's body is determined based on the first current and the second current, or a third current is determined based on the first current and the second current, and the third current is sent to the first device, wherein the third current is related to the concentration of the target analyte in the user's body.

18. The method according to claim 17, characterized in that, The biosensor is the biosensor as described in any one of claims 3-9. Determining the concentration of the target analyte in the user's body based on the first current and the second current specifically includes: determining the concentration of the target analyte in the user's body based on the difference between the first current and the second current; or, The third current is the difference between the first current and the second current.

19. The method according to claim 17, characterized in that, Determining the concentration of the target analyte in the user's body based on the first current and the second current specifically includes: The biosensor is identified as either in its early decay or late failure based on the first current and the second current. If early decay or late failure of the biosensor is detected, the concentration of the target analyte in the user's body is determined based on the first current and the second current. If the biosensor does not exhibit early decay or late failure, the concentration of the target analyte in the user's body is determined based on the first current.

20. The method according to claim 19, characterized in that, The method further includes: If the biosensor is found to have either early attenuation or late failure, the phenomenon is identified as early attenuation or late failure based on the implantation time of the biosensor.

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