Sensor calibration method

Abstract

The present invention discloses a sensor calibration method. Before production, batches of sensors are tested to obtain a summary data pair set. The summary data pair set is classified and divided to obtain a typical data pair set, and the set is stored in a computer. During production, a small number of data pairs are tested on sensors to be shipped, and the small number of data pairs are input into the computer. The typical data pair set closest to the small number of data pairs is obtained through calculation. The typical data pair set can be used as a priori data pair set for the sensors to be shipped, and a preset priori calibration function is no longer required. This improves the sensor calibration efficiency, reduces production time, and improves the reliability of the sensor.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of and priority to the following patent application: PCT patent application filed on September 27, 2021, with application number PCT / CN2021 / 120856. Technical Field

[0003] The present invention mainly relates to the field of medical devices, and in particular to a sensor calibration method. Background Art

[0004] In a healthy individual, the pancreas automatically monitors blood glucose levels and secretes the necessary insulin and glucagon. However, in diabetics, the pancreas malfunctions, preventing it from producing the necessary insulin. Therefore, diabetes is a metabolic disease caused by abnormal pancreatic function and is a lifelong condition. Currently, medical technology cannot cure diabetes; the only approach is to control the onset and progression of diabetes and its complications by stabilizing blood sugar levels.

[0005] Diabetics need to check their blood sugar before injecting insulin. Currently, most testing methods can continuously monitor blood sugar levels and transmit the data in real time to a remote device for easy viewing. This method is called continuous glucose monitoring (CGM). This method requires a device attached to the skin, with a probe inserted into the subcutaneous tissue fluid to complete the test.

[0006] The sensor of an analyte detection device requires calibration before use to determine the correspondence between sensor information and in vivo blood glucose concentration information, that is, to determine the sensor's sensitivity. Existing methods use a linear setting of sensor sensitivity based on an a priori calibration function. However, in actual use, sensor sensitivity is not completely linear, resulting in unreliable analyte parameter information detected by the sensor.

[0007] Therefore, the existing technology urgently needs a more reliable sensor calibration method. Summary of the Invention

[0008] An embodiment of the present invention discloses a sensor calibration method, which tests batches of sensors before production to obtain a summary data pair set. The summary data pair set is classified and divided to obtain a typical data pair set, and the set is stored in a computer. During production, a small number of data pairs are tested on sensors to be shipped, and the small number of data pairs are input into the computer. The typical data pair set that is closest to the small number of data pairs is obtained through calculation. The typical data pair set can be used as a priori data pair set for the sensors to be shipped, and a preset priori calibration function is no longer required. This improves the efficiency of sensor calibration, reduces production time, and improves the reliability of the sensor.

[0009] The present invention discloses a sensor calibration method, comprising: providing: batch sensors, testing the batch sensors to obtain i batch data pairs including a first test parameter value and a second parameter value; The batch data pair set is summarized based on the first test parameter value to obtain the summary data pair set D i :

[0010]

[0011] The aggregated data set D i Classify and divide to obtain j typical data pairs D j :

[0012]

[0013] Computer, the computer stores j typical data pairs; and the sensor to be shipped, the sensor to be shipped is tested to obtain z data pairs The computer is also used to obtain the set of typical data pairs that are closest to the z data pairs. And the typical data set The data is input into the memory corresponding to the sensor to be shipped as the prior data pair set of the sensor to be shipped.

[0014] According to one aspect of the present invention, the typical data pair set D j By summarizing the data set D i The classification is obtained by multiple holdout method or cross-validation method.

[0015] According to one aspect of the present invention, the computer calculates the first parameter values of z data pairs respectively. The first parameter value of each typical data set The sum of squares of the differences is the typical data pair set corresponding to the minimum value, which is the typical data pair set closest to the z data pairs.

[0016] According to one aspect of the present invention, the z data pairs are randomly distributed.

[0017] According to one aspect of the present invention, the z data pairs are equidistantly distributed.

[0018] According to one aspect of the present invention, the first parameter value is a current value or a voltage value.

[0019] According to one aspect of the present invention, the second parameter value includes at least a blood glucose concentration value.

[0020] According to one aspect of the invention, the batch of data pairs or the z data pairs are at least partially derived from in vitro testing.

[0021] According to one aspect of the present invention, the number i of batch data pair sets is not less than 100.

[0022] According to one aspect of the present invention, the number j of typical data pair sets is not less than ten.

[0023] According to one aspect of the present invention, a typical data pair set stored in a memory At least some of the data pairs in are adjustable.

[0024] According to one aspect of the invention, the data pairs are adjusted at least in part based on the time parameter difference.

[0025] According to one aspect of the invention, the adjustment of the data pair is based at least in part on physical characteristics of the sensor.

[0026] According to one aspect of the present invention, the physical property of the sensor includes at least one of membrane thickness, active enzyme area, active enzyme volume or electrode resistance.

[0027] According to one aspect of the invention, the alignment of the data pairs is fixed.

[0028] According to one aspect of the invention, the adjustment of the data pairs is linear.

[0029] The present invention also discloses an analyte detection device, comprising: a housing; a sensor, the sensor comprising an internal part and an external part, the internal part being used to penetrate the subcutaneous tissue of a user to obtain a first parameter value; a memory, the memory pre-storing data obtained by collecting typical data. A processor is programmed to retrieve a representative set of data pairs from a memory In a typical data set The first parameter value is indexed to obtain the second parameter value; a transmitter, which is used to send the first parameter value and / or the second parameter value to an external device; and a battery, which is used to provide electrical energy.

[0030] According to one aspect of the invention, the transmitter, memory, sensor, processor and battery are located within the housing.

[0031] According to one aspect of the present invention, the transmitter, sensor, and battery are located within the housing, and the memory and / or processor are located in the external device.

[0032] According to one aspect of the present invention, at least two of the transmitter, the processor, or the memory are integrated into the same device.

[0033] Compared with the prior art, the technical solution of the present invention has the following advantages:

[0034] In the sensor calibration method disclosed in the present invention, batches of sensors are tested before production to obtain a summary data pair set, which is then classified and divided to obtain a typical data pair set, which is then stored in a computer. During production, a small number of data pairs are tested on sensors to be shipped, which are then input into the computer. A typical data pair set closest to the small number of data pairs is obtained through calculation. The typical data pair set can be used as a priori data pair set for sensors to be shipped, and a preset priori calibration function is no longer required. This improves the efficiency of sensor calibration, reduces production time, and simultaneously improves the reliability of the sensor.

[0035] Furthermore, the typical data pair sets are classified and divided according to the multiple hold-out method or the cross-validation method, which ensures the distribution consistency of the typical data pair sets and improves the representativeness and reliability of the typical data pair sets.

[0036] Furthermore, the typical data pair set closest to the sensor to be shipped is obtained by calculating the minimum sum of square differences of the first parameter value, which has a small amount of calculation and high reliability. BRIEF DESCRIPTION OF THE DRAWINGS

[0037] Figure 1 Schematic diagram of the structure of an analyte detection system according to an embodiment of the present invention;

[0038] Figure 2 is a schematic structural diagram of an analyte detection device according to an embodiment of the present invention;

[0039] Figure 3a 2. It is a structural diagram of a wake-up module of an analyte detection device including a photosensitive element according to an embodiment of the present invention;

[0040] Figure 3b 2. It is a functional schematic diagram of a wake-up module of an analyte detection device including a photosensitive element according to an embodiment of the present invention;

[0041] Figure 4a 2. A schematic structural diagram of an analyte detection system including a magnetic component and a magnetic sensing element according to an embodiment of the present invention;

[0042] Figure 4b 2. It is a structural diagram of a wake-up module of an analyte detection device including a magnetic sensing element according to an embodiment of the present invention;

[0043] Figure 4c 2. It is a functional schematic diagram of a wake-up module of an analyte detection device including a magnetic sensing element according to an embodiment of the present invention;

[0044] Figure 5a 2 is a schematic structural diagram of an analyte detection system including an acceleration sensor according to an embodiment of the present invention;

[0045] Figure 5b 2 is a schematic structural diagram of an analyte detection device wake-up module including an acceleration sensor according to an embodiment of the present invention;

[0046] Figure 5c This is a functional schematic diagram of an analyte detection device wake-up module including an acceleration sensor according to an embodiment of the present invention;

[0047] Figure 6a-6b Two structural schematic diagrams of sensors according to embodiments of the present invention;

[0048] Figure 7 A first data pair set according to an embodiment of the present invention;

[0049] Figure 8 Schematic diagram of communication between an analyte detection apparatus and an external device according to an embodiment of the present invention;

[0050] Figure 9 This is a flowchart of the use of the first data pair set according to an embodiment of the present invention;

[0051] Figure 10 A second data pair set according to an embodiment of the present invention;

[0052] Figure 11 A flowchart of the use of the second data pair set according to an embodiment of the present invention;

[0053] Figure 12 This is a flowchart of a first calibration solution according to an embodiment of the present invention;

[0054] Figure 13a is an average data pair set according to an embodiment of the present invention;

[0055] Figure 13b is a set of average range value data pairs according to an embodiment of the present invention;

[0056] Figure 14 This is a flowchart of a second calibration solution according to an embodiment of the present invention;

[0057] Figure 15a A flowchart of calibration based on differences in physical characteristics of sensors according to an embodiment of the present invention;

[0058] Figure 15bA schematic diagram of a visualization curve of a data pair set in a coordinate system according to an embodiment of the present invention;

[0059] Figure 16 Schematic diagram of a data pair set in a second calibration scheme according to an embodiment of the present invention;

[0060] Figure 17 A flowchart of a first method of calibration based on time parameter difference according to an embodiment of the present invention;

[0061] Figure 18 This is a flowchart of a second method of calibration based on time parameter differences according to an embodiment of the present invention. DETAILED DESCRIPTION

[0062] As mentioned above, the existing analyte detection device is calibrated before or during use by linearly setting the sensor sensitivity based on a priori calibration function. However, in actual use, the sensitivity of the sensor is not completely linear, resulting in low reliability of the analyte parameter information detected by the sensor.

[0063] In order to solve this problem, the present invention provides a sensor calibration method, which tests batches of sensors before production to obtain a summary data pair set, classifies and divides the summary data pair set to obtain a typical data pair set, and stores it in a computer. During production, a small number of data pairs are tested on the sensors to be shipped, and the small number of data pairs are input into the computer. The typical data pair set closest to the small number of data pairs is obtained through calculation. The typical data pair set can be used as the prior data pair set of the sensors to be shipped, and a preset prior calibration function is no longer required, which improves the sensor calibration efficiency, reduces production time, and improves the reliability of the sensor.

[0064] Various exemplary embodiments of the present invention will now be described in detail with reference to the accompanying drawings. It should be understood that unless otherwise specifically stated, the relative arrangement of components and steps, numerical expressions and numerical values set forth in these embodiments should not be construed as limiting the scope of the present invention.

[0065] In addition, it should be understood that for ease of description, the sizes of the various components shown in the drawings are not necessarily drawn according to actual proportional relationships. For example, the thickness, width, length or distance of certain units may be enlarged relative to other structures.

[0066] The following description of exemplary embodiments is merely illustrative and is not intended to limit the present invention, its application, or use in any sense. Technologies, methods, and apparatus known to those skilled in the art may not be discussed in detail herein, but to the extent applicable, such technologies, methods, and apparatuses should be considered part of this specification.

[0067] It should be noted that like reference numerals and letters denote like items in the following figures, and thus, once an item is defined or described in one figure, it will not need to be further discussed in the subsequent figure descriptions.

[0068] Figure 1 Figure 1 is a schematic diagram of the structure of an analyte detection system according to an embodiment of the present invention. Analyte detection system 10 includes an auxiliary mounting device 101 and an analyte detection device 102. Auxiliary mounting device 101 includes a housing 1011 and an auxiliary mounting module 1012. In this embodiment of the present invention, auxiliary mounting module 1012 is an ejection mechanism located within housing 1011. Analyte detection device 102 is located at the ejection end of auxiliary mounting module 1012. During use, auxiliary mounting module 1012 can quickly mount analyte detection device 102 on the host's skin surface.

[0069] Figure 2 Figure 1 is a schematic diagram of the structure of an analyte detection device according to an embodiment of the present invention. The analyte detection device 102 includes a housing 1021, a sensor 1022, a transmitter 1023, an internal circuit 1024, a battery 1025, a wake-up module 1026, a memory 1027, and a processor 1028. The sensor 1022 includes an external portion 10221 and an internal portion 10222. The external portion 10221, transmitter 1023, internal circuit 1024, battery 1025, and wake-up module 1026 are all located within the housing 1021. The internal portion 10222 extends through a through hole 10211 in the housing 1021 to the outside of the housing, thereby piercing the host's skin and detecting analyte parameter information. Those skilled in the art will appreciate that, in order to allow internal portion 10222 to penetrate the host's skin, through-hole 10211 is located on the side of housing 1021 away from shell 1011. Adhesive tape (not shown) is also provided on this side to affix analyte detection device 102 to the host's skin surface. External portion 10221 is electrically connected to transmitter 1023 via internal circuit 1024, enabling transmission of analyte parameter information to external devices.

[0070] Before use, the shell 1021 of the analyte detection device 102 is releasably connected to the shell 1011 of the auxiliary mounter 101. Here, "releasably connected" means that the shell 1021 and the shell 1011 are connected together by means of snaps, clamps, etc. Under the action of the ejection mechanism of the auxiliary mounting module 1012, the shell 1021 can be separated from the shell 1011.

[0071] When the service life of the sensor 1022 ends, or the battery 1025 is exhausted, or other factors cause the analyte detection device to fail, the user removes the entire analyte detection device from the host's skin surface, discards it all, and replaces it with a new analyte detection device. This helps to keep each component in the best use state and improve the reliability of the analyte detection device.

[0072] When the analyte detection device 102 is installed on the host's skin surface and begins to be used, it needs to establish communication with external devices such as PDM (Personal Diabetes Manager) and mobile phones to exchange data and transmit the detected analyte information data in the host's body to the external devices.

[0073] As described above, before the analyte detection device 102 formally establishes communication with an external device, it is in a dormant state and transmits signals to the external device at a first frequency. In an embodiment of the present invention, the analyte detection device 102 transmits signals to the external device at a lower first frequency in the dormant state to reduce battery energy consumption. In a more preferred embodiment of the present invention, the first frequency is 0 to 12 times / hour. In a more preferred embodiment of the present invention, the first frequency is 0 times / hour, that is, the analyte detection device 102 does not transmit signals to the external device in the dormant state.

[0074] To establish communication between the analyte detection device 102 in the dormant state and an external device, the wake-up module 1026 wakes up the analyte detection device 102 according to a trigger condition, causing it to enter the operating state and transmit a signal to the external device at a second frequency. Communication is established after the external device responds. To facilitate convenient and real-time access to analyte parameter information by the user, the second frequency is higher than the first frequency. In a preferred embodiment of the present invention, the second frequency is 12 to 3600 times / hour. In a more preferred embodiment of the present invention, the second frequency is 30 times / hour.

[0075] Example 1

[0076] Photosensitive element

[0077] Figure 3a This is a structural schematic diagram of the wake-up module of the analyte detection device according to an embodiment of the present invention, including a photosensitive element. Figure 3b This is a functional schematic diagram of the wake-up module of the analyte detection device including a photosensitive element according to an embodiment of the present invention.

[0078] In an embodiment of the present invention, the wake-up module 1026 includes a photosensitive element 10261, such as a photoelectric switch. When there is no light beam or a weak light beam, the photosensitive element 10261 is in an open state. When there is a light beam, the photosensitive element 10261 is in a closed state.

[0079] Combine Figure 1 and Figure 3b The transmitter 1023 is connected to the battery 1025 through the internal circuit 1024 to form a closed loop. The circuit is connected to the wake-up module 1026, and the wake-up module 1026 is connected to the photosensitive element 10261. The trigger condition of the wake-up module 1026 is the change in the light intensity received by the photosensitive element 10261.

[0080] In a preferred embodiment of the present invention, the triggering condition for the awakening module 1026 is that the intensity of the light received by the photosensitive element 10261 changes from weak to strong.

[0081] In an embodiment of the present invention, before the analyte detection device 102 is installed on the surface of the host skin, the analyte detection device 102 is not separated from the auxiliary mounter 101, and the outer shell 1021 and the shell 1011 form a closed and light-proof space. Since the light-transmitting area 10211 of the outer shell 1021 is located at one end close to the shell 1011, no external light is irradiated on the photosensitive element 10261 at this time. The battery 1025 supplies power to the transmitter 1023 through the wake-up module 1026 (including the photosensitive element 10261), the photosensitive element 10261 is in an open circuit state, the transmitter 1023 is in a sleep state, and the analyte detection device 102 transmits a signal to the external device at a first frequency. After the analyte detection device 102 is installed on the host skin surface through the auxiliary installation module 1012, the shell 1021 is separated from the shell 1011, and the external light is irradiated onto the photosensitive element 10261 through the shell 1021. The photosensitive element 10261 is in a closed circuit state, and the transmitter 1023 enters the working state. The analyte detection device 102 transmits a signal to the external device at a second frequency, establishes communication after the external device responds, and transmits analyte detection data to the external device.

[0082] In an embodiment of the present invention, the shell 1021 is made of a light-transmitting material, such as polymethyl methacrylate (PMMA), polystyrene (PS), polycarbonate (PC) or poly-4-methyl-1-pentene (TPX). The light transmittance of the above materials is 40% to 95%. After the shell 1021 is separated from the shell 1011, external light can pass through the shell 1021 and irradiate the photosensitive element 10261.

[0083] In other embodiments of the present invention, the shell 1021 includes a light-transmitting area 10211, and the light transmittance of the light-transmitting area 10211 is higher than that of the shell 1021, so that more external light can be irradiated on the photosensitive element 10261, thereby increasing the light intensity variation of the photosensitive element 10261 and improving the reliability of the photosensitive element 10261.

[0084] In another embodiment of the present invention, light-transmitting region 10211 includes at least one light-transmitting hole, or an array of multiple light-transmitting holes. The light-transmitting holes allow more external light to illuminate photosensitive element 10261, further increasing the variation in light intensity of photosensitive element 10261 and improving the reliability of photosensitive element 10261. In a preferred embodiment of the present invention, a light-transmitting film (not shown) is provided in the light-transmitting hole to prevent external contaminants such as water droplets and dust from entering the analyte detection device through the light-transmitting hole, thereby improving the reliability of the device.

[0085] In an embodiment of the present invention, the light sensing element 10261 can sense visible light or invisible light, such as infrared or ultraviolet light. In a preferred embodiment of the present invention, the light sensing element 10261 senses visible light so that the user can wake up the analyte detection device indoors or outdoors.

[0086] In another embodiment of the present invention, the open-circuit and closed-circuit switching conditions of the photosensitive element are when weak light irradiation is switched to strong light irradiation, that is, before the housing 1021 is separated from the shell 1011, weak external light is allowed to irradiate the interior of the shell 1011, and the photosensitive element 10261 receives the weak light, but remains in the open-circuit state, and the transmitter 1023 is in the dormant state. This is because the actual connection between the housing 1021 and the shell 1011 is not completely sealed. After the housing 1021 is separated from the shell 1011, external light shines on the photosensitive element 10261 through the housing 1021 or the light-transmitting area 10211. The intensity of the light received by the photosensitive element 10261 increases. After reaching a set light intensity threshold, the photosensitive element 10261 switches to the closed-circuit state, and the transmitter 1023 enters the working state, transmitting a signal to the external device at the second frequency, establishing communication after the external device responds, and transmitting the analyte detection data to the external device.

[0087] Example 2

[0088] Magnetic parts and magnetic sensing elements

[0089] Figure 4a Schematic diagram of the structure of an analyte detection system including a magnetic component and a magnetic sensing element according to an embodiment of the present invention. Figure 4b This is a structural diagram of the wake-up module of the analyte detection device according to an embodiment of the present invention, including a magnetic sensing element. Figure 4c This is a functional schematic diagram of the wake-up module of the analyte detection device according to an embodiment of the present invention including a magnetic sensing element.

[0090] In this embodiment of the present invention, a magnetic member 203 is disposed on the housing 2011, and a magnetic sensing element 20261 is disposed within the wake-up module 2026. The magnetic member 203 provides a stable magnetic field. The magnetic sensing element 20261 is located within the magnetic field of the magnetic member 203 and senses the magnetic field of the magnetic member 203 to generate a signal. The trigger condition for the wake-up module 2026 is a change in the magnetic field sensed by the magnetic sensing element 20261.

[0091] Transmitter 2023 is connected to battery 2025 via internal circuit 2024, forming a closed loop. A wake-up module 2026 is connected to the circuit, and battery 2025 supplies power to transmitter 2023 via wake-up module 2026 (including magnetic sensing element 20261). Before analyte detection device 202 is mounted on the host's skin surface, analyte detection device 202 is not separated from auxiliary mounting device 201, and their relative positions are fixed. The magnetic field sensed by magnetic element 20261 from magnetic member 203 is stable. Under this stable magnetic field, magnetic sensing element 20261 is in an open circuit state, transmitter 2023 is in a dormant state, and analyte detection device 202 transmits signals at a first frequency to an external device. After the analyte detection device 202 is installed on the host skin surface through the auxiliary installation module 2012, the outer shell 2021 is separated from the shell 2011, and the distance between the magnetic sensing element 20261 and the magnetic part 203 changes, so the induced magnetic field also changes. The magnetic sensing element 20261 switches to a closed-circuit state, and the transmitter 2023 enters the working state. The analyte detection device 202 transmits a signal to the external device at a second frequency, establishes communication after the external device responds, and transmits analyte detection data to the external device.

[0092] In the embodiment of the present invention, the magnetic sensing element 20261 senses the magnetic field strength or magnetic field direction of the magnetic member 203. Preferably, the magnetic sensing element 20261 includes a Hall element (not shown in the figure) that can sensitively sense changes in the magnetic field strength of the magnetic member 203.

[0093] In the embodiment of the present invention, the magnetic component 203 may be an individual part independent of the housing 2011 , or may be a part of the housing 2011 and embedded in the housing 2011 .

[0094] In other embodiments of the present invention, a magnetic field shielding device (not shown), such as a Faraday cage, is embedded in or enclosed by the housing 2011. Those skilled in the art will appreciate that the magnetic field shielding device is located outside the magnetic member 203 to reduce the impact of the external magnetic field on the magnetic sensing element 20261.

[0095] Example 3

[0096] Accelerometer

[0097] Figure 5aThis is a structural diagram of an analyte detection system wake-up module including an acceleration sensor according to an embodiment of the present invention. Figure 5b This is a structural diagram of an analyte detection device wake-up module including an acceleration sensor according to an embodiment of the present invention. Figure 5c This is a functional schematic diagram of an analyte detection device wake-up module including an acceleration sensor according to an embodiment of the present invention.

[0098] In this embodiment of the present invention, the wake-up module 3026 includes an accelerometer 30261, which can sensitively sense motion parameters such as acceleration and adjust the circuit state of the wake-up module 3026 accordingly. The trigger condition for the wake-up module 3026 is a change in the motion parameters of the accelerometer 30261.

[0099] The transmitter 3023 is connected to a battery 3025 via an internal circuit 3024, forming a closed loop. A wake-up module 3026 is connected to the circuit, and the battery 3025 supplies power to the transmitter 3023 via the wake-up module 3026 (including an accelerometer 30261). Before the analyte detection device 302 is mounted on the host's skin surface, the analyte detection device 302 and the auxiliary mounting device 301 remain relatively fixed. To insert the internal portion 30222 of the analyte detection device sensor into the host's subcutaneous tissue and reduce pain during insertion, the auxiliary mounting module 3012 utilizes an ejection mechanism 30121, such as a spring or other elastic member, to quickly insert the internal portion 30222 into the host's subcutaneous tissue via an auxiliary needle 30122. The ejection mechanism 30121 generates a large instantaneous positive acceleration a1 when in use. After being installed on the host's skin surface, it is blocked by the skin and generates a reverse acceleration a2. After the acceleration sensor 30261 senses the above two accelerations, it can be determined that the analyte detection device 302 is installed on the host's skin surface.

[0100] In this embodiment of the present invention, before the analyte detection device 302 is attached to the host's skin, the wake-up module 3026 is in an open circuit state, the transmitter 3023 is in a dormant state, and the analyte detection device 302 transmits signals at a first frequency to an external device. After the acceleration sensor 30261 determines that the analyte detection device 302 is attached to the host's skin, the wake-up module 3026 switches to a closed circuit state, the transmitter 3023 enters an active state, and the analyte detection device 302 transmits signals at a second frequency to the external device. After the external device responds, communication is established and the analyte detection data is transmitted to the external device.

[0101] Continue to refer to Figure 2In this embodiment of the present invention, sensor 1022 includes an external portion 10221 and an internal portion 10222. External portion 10221 is laid flat on the inside of housing 1021, reducing the height of the sensor and, therefore, the thickness of the analyte detection system. Internal portion 10222 is bent relative to external portion 10221 and extends through through-hole 10211 in the housing to the outside.

[0102] In a preferred embodiment of the present invention, the internal portion 10222 is bent at 90° relative to the external portion 10221.

[0103] In an embodiment of the present invention, the internal part 10222 is inserted into the subcutaneous tissue of the user to obtain the first parameter value, and the external part 10221 is electrically connected to the internal circuit 1024 .

[0104] Figure 6a 、 Figure 6b Schematic diagrams of two structures of sensors according to embodiments of the present invention.

[0105] refer to Figure 6a In this embodiment of the present invention, the internal portion 10222 includes two electrodes, a working electrode and a counter electrode, which are electrically connected to pins 1 and 2 via wires 1 and 2, respectively. Pins 1 and 2 are provided on the external portion 10221 and are electrically connected to the internal circuit 1024. The electrodes, wires, and pins are all fixed to an insulating substrate.

[0106] refer to Figure 6b In this embodiment of the present invention, the internal portion 10222 includes three electrodes: a working electrode, a counter electrode, and a reference electrode. These electrodes are electrically connected to pins 1, 2, and 3 via wires 1, 2, and 3, respectively. Pins 1, 2, and 3 are provided on the external portion 10221 and electrically connected to the internal circuit 1024. The electrodes, wires, and pins are all secured to an insulating substrate.

[0107] In an embodiment of the present invention, an active enzyme layer capable of reacting with an in vivo analyte is also provided on the electrode. For example, when the in vivo analyte is glucose, the active enzyme layer is a glucose active enzyme. When the glucose active enzyme comes into contact with glucose in the body, the glucose active enzyme reacts with the glucose in the body according to the glucose concentration f(x n Different values of the second parameter will generate different numbers of electrons, thus forming different current values or voltage values x on the electrodes. n That is, a priori data pair of the first parameter value and the second parameter value can be obtained, and when using sensor 1022, the second parameter value can be inferred based on the first parameter value. In a preferred embodiment of the present invention, the first parameter value is the current value of sensor 1022.

[0108] In other embodiments of the present invention, the in vivo analyte may also be other in vivo substances such as adrenaline, thyroid hormone, hemoglobin, etc., which are not limited here.

[0109] In other embodiments of the present invention, the second parameter value may also be other parameters of the in vivo analyte, such as the type of analyte.

[0110] In some embodiments of the present invention, the prior data pair of the first parameter value and the second parameter value can be obtained by in vitro testing. For example, the sensor 1022 is placed in different concentrations of f(x n )(second parameter value) in the analyte solution, providing a standard operating voltage, measuring the feedback current value x of the sensor 1022 n (first parameter value), we get Figure 7 The first set of data pairs is shown.

[0111] In other embodiments of the present invention, the prior data pair of the first parameter value and the second parameter value can be obtained by in vivo testing. For example, the sensor 1022 is inserted into the user's body, a standard operating voltage is provided, and the analyte concentration f(x n )(second parameter value), and at the same time measure the feedback current value x of sensor 1022 n When obtaining a priori data pairs through in vivo testing, interference from other analytes and environmental factors in the body on the first parameter value can be eliminated, and the a priori data pairs obtained through testing are more accurate.

[0112] In some further embodiments of the present invention, a portion of the prior data pair set of the first parameter value and the second parameter value may be obtained through in vivo testing, and another portion may be obtained through in vitro testing.

[0113] In a preferred embodiment of the present invention, the prior data set of the first parameter value and the second parameter value is obtained by in vitro testing. During the in vitro testing, the accuracy and range of the second parameter value can be manually controlled to obtain a data set with higher accuracy and wider range.

[0114] In some embodiments of the present invention, the analyte concentration f(x n ) range is 30mg / dL~150mg / dL, with an accuracy of 0.1mg / dL, for example, f(x1)=30mg / dL, f(x2)=30.1mg / dL... and respectively obtain the current values x1, x2 of the sensor 1022 at the corresponding concentrations... Thus, a set of 1201 data pairs is obtained. In other embodiments of the present invention, the analyte concentration f(x1) is preset during the test. n) range is 10 mg / dL to 200 mg / dL, with an accuracy of 1 mg / dL. For example, f(x1) = 10 mg / dL, f(x2) = 11 mg / dL, and the current values x1 and x2 of sensor 1022 at the corresponding concentrations are obtained, respectively. This results in a set of 191 data pairs. Different test ranges and test accuracies can be set based on the memory space available in the analyte detection system and actual usage requirements.

[0115] In an embodiment of the present invention, after obtaining a data pair set of the first parameter value and the second parameter value through testing, the data pair set is input into a memory of the analyte detection system for retrieval and indexing when used.

[0116] Figure 8 Schematic diagram of the analyte detection system. Figure 9 A flowchart of the use of the first data pair set for the analyte detection system.

[0117] Combined with reference Figure 2 、 Figure 8 and Figure 9 In some embodiments of the present invention, a priori data pair set is stored in the memory 1027. After the sensor 1022 penetrates the user's subcutaneous tissue, it obtains a first parameter value (current value), which is input into the processor 1028. The processor 1028 retrieves the priori data pair set from the memory 1027, obtains a second parameter value based on the current value index obtained by the sensor 1022, and obtains the in vivo analyte concentration. The concentration is then sent by the transmitter 1023 to a remote device for the user's reference.

[0118] Given the limited size of internal circuit 1024, the memory 1027 and processor 1028 are also limited in size, making it impossible to store large sets of data pairs or perform extensive data operations. In other embodiments of the present invention, memory 1027 and processor 1028 are located in a remote device, such as a handheld device, mobile phone, or computer. After sensor 1022 acquires the current value, transmitter 1023 transmits it to processor 1028 in the remote device. Processor 1028 retrieves the prior data pair set from memory 1027 and, based on the current value index acquired by sensor 1022, obtains a second parameter value, thereby obtaining the in vivo analyte concentration for the user's reference.

[0119] In some further embodiments of the present invention, the memory 1027 is located in a remote device, and the processor 1028 is located in the local internal circuit 1024. In some further embodiments of the present invention, the processor 1028 is located in a remote device, and the memory 1027 is located in the local internal circuit 1024.

[0120] In certain embodiments of the present invention, the memory 1027 and the processor 1028 may be integrated into the same electronic device, such as a CPU, MCU, etc. In certain embodiments of the present invention, the processor 1028 and the transmitter 1023 may be integrated into the same electronic device, such as a radio frequency chip, etc. In certain embodiments of the present invention, the memory 1027 and the transmitter 1023 may be integrated into the same electronic device. In certain embodiments of the present invention, the transmitter 1023, the memory 1027, and the processor 1028 may be integrated into the same electronic device.

[0121] In other embodiments of the present invention, the indexing function of processor 1028 can also be implemented in hardware, for example, by a filter composed of multiple comparators with different high and low thresholds, each of which is connected to a transmitter. The transmitter transmits a predetermined signal associated with the blood glucose concentration information (the second parameter value) or the current value information (the first parameter value). When sensor 1022 acquires current, the current enters the filter. Currents of different intensities can only pass through comparators with a high threshold value above their value and a low threshold value below their value. At the same time, the transmitter connected to the comparator is activated and transmits a predetermined signal to the remote device.

[0122] Considering that the prior data pair set is discrete, in some cases, the current value of sensor 1022 does not exist in the prior data pair set, resulting in the processor 1028 failing to index and being unable to obtain the corresponding analyte concentration value. To address this situation, in a preferred embodiment of the present invention, the processor 1028 needs to perform an interpolation operation when performing indexing. For example, when the current value detected by sensor 1022 is x, the x value does not exist in the prior data pair set, and the x value is between two adjacent first parameter values x recorded in the prior data set. -1 and x +1 Therefore, the analyte concentration f(x) corresponding to the current value x can be calculated by interpolation:

[0123]

[0124] In the embodiment of the present invention, the higher the accuracy of the prior data set, the higher the accuracy of the result obtained by the interpolation operation.

[0125] In the case where the processor 1028 index is not found, in a preferred embodiment of the present invention, the analyte concentration f(x n) range is 30 mg / dL to 150 mg / dL, with an accuracy of 0.1 mg / dL, for example, f(x1) = 30 mg / dL, f(x2) = 30.1 mg / dL... and respectively obtain the current values x1, x2 of the sensor 1022 at the corresponding concentrations... When setting the prior logarithm set, the first parameter value is set to the range value of the average value of the adjacent first parameter values. For example, the current value corresponding to the analyte concentration f(x2) is The current value corresponding to f(x3) is And so on. It should be noted that the head analyte concentration value f(x1) and the tail analyte concentration value f(x n ) respectively correspond to the current values and Get as Figure 10 The second data pair set is shown. In this data pair set, the first parameter value is continuous and there will be no index failure. For example, when the current value detected by the sensor 1022 is x, the processor 1028 determines that the value satisfies Then we can get the analyte concentration at this time as f(x 299 ).

[0126] Figure 11 A flowchart of the use of the second data pair set for the analyte detection system.

[0127] In an embodiment of the present invention, a priori data pair set is stored in the memory 1027. After the sensor 1022 penetrates the user's subcutaneous tissue, a first parameter value (current value) is obtained and the first parameter value is input to the processor 1028. The processor 1028 retrieves the priori data pair set from the memory 1027, and determines the range interval into which the first parameter value falls. The second parameter value is obtained according to the range interval index to obtain the analyte concentration information in the body.

[0128] Based on market demand, and considering that sensors 1022 need to be mass-produced and used, a batch of sensors may contain thousands or even tens of thousands of sensors. Each sensor's manufacturing parameters and physical characteristics may vary. If every sensor were to be tested with high precision, for example, 1201 times per sensor, this would consume a significant amount of production time for the manufacturer. Given this situation, an efficient sensor calibration solution is needed.

[0129] Figure 12 This is a flowchart of the first calibration solution according to an embodiment of the present invention.

[0130] In the embodiment of the present invention, m samples are taken from a batch of sensors, for example, 10,000 sensors, and tested to obtain a data pair set of each sample. The first test parameter value for all sample data pairs Perform averaging to obtain the sample average first test parameter value Then average the first test parameter value of the sample Assign the first parameter value to all sensors in this batch, and get Figure 13a The average data set shown The average data pair set is used as the prior data pair set of the sensors in this batch and is input into the memory 1027.

[0131] In an embodiment of the present invention, m can be selected as 1 / 100, 1 / 50, or 1 / 20 of the number of sensors in the same batch. The more samples taken, the higher the average data set accuracy, but the more testing time is spent. In a preferred embodiment of the present invention, m is selected as 1 / 50 of the number of sensors in the same batch.

[0132] Considering that the average first parameter value assigned to the batch of sensors is a discrete value, the processor 1028 may also encounter an index failure.

[0133] In some embodiments of the present invention, the processor 1028 needs to perform an interpolation operation when performing indexing. For example, when the current value detected by the sensor 1022 is x, the value x does not exist in the prior data set, but is located between two adjacent average first parameter values recorded in the prior data set. and Therefore, the analyte concentration f(x) corresponding to the current value x can be calculated by interpolation:

[0134]

[0135] In other embodiments of the present invention, when setting the prior data pair set, the first parameter value of the batch sensor is set to a range value consisting of the average value of the adjacent average first test parameter values. For example, the current value corresponding to the analyte concentration f(x2) is The current value corresponding to f(x3) is And so on. It should be noted that the head analyte concentration value f(x1) and the tail analyte concentration value f(x n ) respectively correspond to the current values and Get as Figure 13b The average range value data set shown. In this data set, the average first test parameter value is continuous and there will be no index failure. For example, when the current value detected by sensor 1022 is x, processor 1028 determines that the value meets Then we can get the analyte concentration at this time as f(x 299 ).

[0136] Figure 14 This is a flowchart of the second calibration solution according to an embodiment of the present invention.

[0137] Considering that in the sample calibration scheme, the manufacturer still needs to perform high-precision testing on a large number of samples, which will still consume a lot of production time. In the embodiment of the present invention, a batch (for example, i) of sensors can be tested before production to obtain a batch of prior data pairs including the first test parameter value and the second parameter value. The number of sensors in a batch i can be 100, 1000, 10,000 or more. The larger the number, the more conducive it is to the classification and division of the subsequent data pairs. Because the second parameter value is consistent when testing the sensors, the batch prior data pairs are summarized based on the first test parameter value to obtain the summary data set D i :

[0138]

[0139] The above summary data are grouped into set D i Classify and divide according to the Hold-out Method or Cross Validation Method to obtain j typical data sets D j :

[0140]

[0141] In the embodiment of the present invention, the number of j typical data pair sets can be 10, 20, 50, 100 or more. The greater the number of typical data pair sets, the more accurate the classification of the data pair sets, but it will also result in a greater amount of subsequent calculations. j A set of data pairs that can characterize all sensors.

[0142] In the embodiment of the present invention, a typical data pair set D is obtained. j Then, the above typical data set D j Stored in the computer of the production line, during formal production, only z data pairs need to be tested on the factory sensors. Select the typical data pair set closest to the z data pairs The data set The prior data pair set of the sensor to be shipped is stored in the memory 1027 corresponding to the sensor. Compared with the sample calibration scheme, the typical data pair calibration scheme can further save production time and improve production efficiency during production.

[0143] In the embodiment of the present invention, the typical data pair set closest to the z data pairs can be obtained by minimizing the sum of squared differences. Input into the computer, the computer will calculate the first test parameter value Bring in j typical data sets D respectively j Calculate in, and get A typical dataset The closest typical data pair set can most approximately represent the actual data pair set of the sensor to be shipped. At the same time, the computer inputs the typical data pair set into the memory corresponding to the sensor to be shipped as the prior data pair set of the sensor to be shipped.

[0144] In an embodiment of the present invention, the z data pairs tested for the sensor to be shipped can be 10, 50, or 100, etc. The more data pairs tested, the closer the typical data pair set found by calculation is to the actual data pair set of the sensor to be shipped. However, this also results in increased production time and greater computational complexity.

[0145] Figure 15a This is a flowchart of a calibration process based on differences in sensor physical characteristics according to an embodiment of the present invention; Figure 15b Schematic diagram of a visualization curve of a data pair set in a coordinate system according to an embodiment of the present invention.

[0146] Taking into account the differences in physical properties between sensors, such as membrane thickness, active enzyme layer area, active enzyme layer volume or electrode resistance, there is a fixed difference or linear difference between the actual data pair set of the sensor to be shipped and the closest typical data pair set or other prior data pair set, such as Figure 15b As shown. Figure 15b Middle, curve and Characterize the actual data set of the sensor to be shipped, curve Characterize the closest typical data pair set, Relative to There is a fixed difference. Relative to There is a linear difference.

[0147] Continue to refer Figure 15a In the embodiment of the present invention, the closest typical data pair set is found in the sensor to be shipped. Finally, the z data pairs tested are compared with the typical data pair set to see if there is a fixed difference or a linear difference. If there is no difference, the typical data pair set is Input into the memory; if there is a difference, it is necessary to The first parameter value in is adjusted to minimize the difference between the typical data set and the actual data set, and the adjusted data set is Enter into memory.

[0148] In the embodiment of the present invention, for a typical data set The adjustment of the first parameter value can be achieved by adjusting the function x t accomplish:

[0149] x t =a*x+b

[0150] Where,

[0151] a is the linear adjustment coefficient;

[0152] b is the fixed adjustment coefficient;

[0153] x is the first parameter value in the typical data set before adjustment.

[0154] In the embodiment of the present invention, the fixed adjustment coefficient b is calculated from the fixed difference between the actual sensor data pair set and the typical data pair set, and the linear adjustment coefficient a is calculated from the linear difference between the actual sensor data pair set and the typical data pair set.

[0155] Figure 16 Schematic diagram of a data pair set in the second calibration scheme according to an embodiment of the present invention.

[0156] In the embodiment of the present invention, z data pairs to be tested on the factory sensor are selected using an equidistant distribution, such as Figure 16 shown.

[0157] In other embodiments of the present invention, the z data pairs for the sensor to be tested are selected using random distribution.

[0158] Considering that during the use of the analyte detection system, as the use time increases, the prior data pair set and the actual data pair set of the sensor deviate due to factors such as changes in the activity of the sensor enzyme layer and electrode oxidation, and this deviation will continue to change, therefore, storing a fixed prior data pair set in the memory cannot meet the long-term use requirements of the sensor.

[0159] Figure 17 This is a first flow chart of calibration based on time parameter difference according to an embodiment of the present invention.

[0160] In the embodiment of the present invention, a test is performed on the sensor to be shipped at time t0 to obtain a first priori data pair set D at time t0. t0 , perform another test at time t1 to obtain the second prior data set D at time t1 t1...This process is repeated to obtain multiple prior data pairs based on time parameter differences and input them into the memory corresponding to the sensor to be shipped. At the same time, the processor is programmed to retrieve the first prior data pair set D from the memory at time t0-t1 t0 After the sensor obtains the first parameter value, the processor t0 The second parameter value is obtained based on the first parameter value index; the second prior data set D is retrieved from the memory at time t1-t2 t1 After the sensor obtains the first parameter value, the processor uses the second prior data set D t1 The second parameter value is obtained based on the first parameter value index... until the service life of the sensor ends or the analyte detection device stops working.

[0161] In an embodiment of the present invention, the number of prior data pair sets input into the memory is determined by the test interval time Δt and the service life T of the sensor. For example, when the service life T of the sensor is 14 days and the test interval time Δt is 1 day, the number of prior data pair sets is T / Δt=14.

[0162] In some embodiments of the present invention, the plurality of prior data pairs based on time parameter differences may be as follows: Figure 7 or as Figure 13a The data pair set shown is indexed using interpolation when used.

[0163] In some embodiments of the present invention, multiple prior data pairs based on time parameter differences may also be as follows: Figure 10 or as Figure 13b The data pair set shown is indexed based on the range interval that the first parameter value falls into when used.

[0164] In some embodiments of the present invention, multiple prior data pairs based on time parameter differences may also be as follows: Figure 16 As shown in the typical data pair set, j typical data pair sets are set in time periods such as t0-t1, t1-t2, and t2-t3. Then, through calculation, the typical data pair set closest to the sensor to be shipped is found in each time period and stored in the memory 1027 corresponding to the sensor. Accordingly, the processor 1028 is programmed to retrieve the typical data pair set for indexing in each time period.

[0165] Figure 18 This is a second flow chart of calibration based on time parameter difference according to an embodiment of the present invention.

[0166] In the embodiment of the present invention, the memory 1027 also stores a priori calibration function f(x) based on the time parameter difference. t :

[0167] f(x)t =f(x)+a(t)*x+c,

[0168] in,

[0169] f(x) t is the adjusted second parameter value;

[0170] f(x) is the value of the second parameter before adjustment;

[0171] a(t) is the a priori calibration proportional coefficient, which is related to the usage time of the sensor; c is the a priori calibration constant.

[0172] In some embodiments of the present invention, the a priori calibration scale factor and a priori calibration constant are obtained by testing sensors to be shipped. In other embodiments of the present invention, the a priori calibration scale factor and a priori calibration constant are obtained by sampling a batch of sensors, and then averaging the sample data before assigning it to the batch of sensors.

[0173] Reference Figure 18 In an embodiment of the present invention, when using the analyte detection system, the sensor 1022 obtains a first parameter value and inputs it to the processor 1028. The processor 1028 retrieves a data pair set and a priori calibration function based on time parameter differences from the memory 1027. The processor 1028 first obtains a second parameter value by indexing in the data pair set based on the first parameter value, and adjusts the obtained second parameter value through the priori calibration function to obtain the adjusted second parameter value, and sends it to the remote device.

[0174] In other embodiments of the present invention, sensor 1022 obtains a first parameter value and inputs it to processor 1028. Processor 1028 retrieves a data pair set and a priori calibration function based on time parameter differences from memory 1027. Processor 1028 first retrieves a second parameter value from the data pair set based on the first parameter value and outputs it to the remote device. The data pair set is then adjusted according to the priori calibration function and the adjusted data pair set is stored in memory 1027 as the data pair set to be retrieved for the next detection cycle. In some embodiments of the present invention, the adjustment to the data pair set is to adjust the first parameter value while keeping the second parameter value unchanged. In other embodiments of the present invention, the adjustment to the data pair set is to adjust the first parameter value and the second parameter value simultaneously. In still other embodiments of the present invention, the adjustment to the data pair set is to adjust the second parameter value while keeping the first parameter value unchanged.

[0175] Combined with reference Figure 7 、 Figure 9 、 Figure 10 、 Figure 11 、 Figure 13a 、 Figure 13b 、 Figure 17 and Figure 18. In an embodiment of the present invention, a first parameter threshold is provided in the processor 1028 and corresponds to a first parameter value, such as a current threshold or a voltage threshold. The first parameter threshold includes a high threshold with a higher value and a low threshold with a lower value, and the area between the high threshold and the low threshold is a normal interval. When the sensor 1022 obtains the first parameter value and inputs it to the processor 1028, the processor 1028 compares the first parameter value with the first parameter threshold. If the first parameter value exceeds the higher high threshold, it is determined that there is a risk of hyperglycemia. If the first parameter value is lower than the lower low threshold, it is determined that there is a risk of hypoglycemia. When the processor 1028 determines that there is a risk of high or low blood sugar, it outputs an alarm indication.

[0176] In other embodiments of the present invention, a second parameter threshold is provided in the processor 1028 and corresponds to a second parameter value, such as a blood glucose concentration threshold. The second parameter threshold includes a higher high threshold and a lower low threshold, and the area between the high threshold and the low threshold is a normal interval. After the processor 1028 indexes and obtains the second parameter value, the processor 1028 compares the second parameter value with the second parameter threshold. If the second parameter value exceeds the higher high threshold, it is determined that there is a risk of hyperglycemia. If the second parameter value is lower than the lower low threshold, it is determined that there is a risk of hypoglycemia. When the processor 1028 determines that there is a risk of high or low blood glucose, it outputs an alarm indication.

[0177] In the embodiment of the present invention, the alarm indication may be processed by the local internal circuit 1024 or by a remote device. After the alarm indication is processed, it prompts the user or other monitoring personnel in one or more forms such as light, sound, and vibration.

[0178] In an embodiment of the present invention, the first parameter threshold or the second parameter threshold in the processor 1028 can be set by a user or by a non-user. For example, the first parameter threshold or the second parameter threshold is set in the processor 1028 at the factory, or the first parameter threshold or the second parameter threshold is set by other guardians.

[0179] In summary, the present invention provides a sensor calibration method, which tests batches of sensors before production to obtain a summary data pair set, classifies and divides the summary data pair set to obtain a typical data pair set, and stores it in a computer. During production, a small number of data pairs are tested on the sensors to be shipped, and the small number of data pairs are input into the computer. The typical data pair set closest to the small number of data pairs is obtained by calculation. The typical data pair set can be used as the prior data pair set of the sensors to be shipped, and a preset prior calibration function is no longer required, which improves the sensor calibration efficiency, reduces production time, and improves the reliability of the sensor.

[0180] Although some specific embodiments of the present invention have been described in detail by way of example, it should be understood by those skilled in the art that the above examples are for illustration only and are not intended to limit the scope of the present invention. It should be understood by those skilled in the art that modifications may be made to the above embodiments without departing from the scope and spirit of the present invention. The scope of the present invention is defined by the appended claims.

Claims

1. A sensor calibration method, characterized in that: include: supply Batch sensors, testing the batch sensors to obtain a batch data set including a first test parameter value and a second parameter value The batch data pair set is aggregated based on the first test parameter value to obtain an aggregated data pair set D i , i is the number of sensors, and the first test parameter value is the first parameter value obtained by testing the batch of sensors: The summary data set D i Classify and divide to obtain j typical data pairs D j : A computer storing the j typical data pair sets; and The sensor to be shipped is tested to obtain z data pairs. The computer is further configured to obtain a typical data pair set closest to the z data pairs. And the typical data set The data are input into the memory corresponding to the sensor to be shipped as a priori data pair set of the sensor to be shipped.

2. The sensor calibration method according to claim 1, characterized in that: The typical data set D j The summary data set D i The classification is obtained by multiple holdout method or cross-validation method.

3. The sensor calibration method according to claim 1, characterized in that: The computer calculates the first test parameter values of the z data pairs respectively The first test parameter value of each typical data set The sum of squares of the differences between the two, the typical data pair set corresponding to the minimum value is the typical data pair set closest to the z data pairs.

4. The sensor calibration method according to claim 3, characterized in that: The z data pairs are randomly distributed.

5. The sensor calibration method according to claim 3, characterized in that: The z data pairs are equally distributed.

6. The sensor calibration method according to claim 1, characterized in that: The first test parameter value is a current value or a voltage value.

7. The sensor calibration method according to claim 1, characterized in that: The second parameter value includes at least a blood glucose concentration value.

8. The sensor calibration method according to claim 1, characterized in that: The batch of data pairs or the z data pairs are at least partially derived from in vitro testing.

9. The sensor calibration method according to claim 1, characterized in that: The number i of the batch data pair sets is not less than 100.

10. The sensor calibration method according to claim 1, characterized in that: The number j of the typical data pair sets is not less than 10.

11. The sensor calibration method according to claim 1, characterized in that: The typical data set stored in the memory At least some of the data pairs in are adjustable.

12. The sensor calibration method according to claim 11, characterized in that: The data pair is adjusted at least in part based on a time parameter difference.

13. The sensor calibration method according to claim 11, characterized in that: The adjustment of the data pair is based at least in part on a physical characteristic of the sensor.

14. The sensor calibration method according to claim 13, characterized in that: The physical property of the sensor includes at least one of a membrane thickness, an active enzyme area, an active enzyme volume or an electrode resistance.

15. The sensor calibration method according to claim 11, characterized in that: The alignment of the data pairs is fixed.

16. The sensor calibration method according to claim 11, characterized in that: The adjustment of the data pairs is linear.

17. An analyte detection device, characterized in that: include shell; A sensor, the sensor comprising an internal portion and an external portion, the internal portion being configured to penetrate subcutaneously to obtain a first parameter value; A memory pre-stored with a typical data set obtained by the sensor calibration method according to claim 1 A processor programmed to retrieve the representative data set from the memory In the typical data set The first parameter value obtained based on the internal body part is indexed to obtain a second parameter value; a transmitter, configured to transmit the first parameter value acquired by the internal body part and / or the second parameter value acquired by the processor to an external device; and A battery is used to provide electrical energy.

18. The analyte detection device according to claim 17, characterized in that The transmitter, memory, sensor, processor and battery are located within the housing.

19. The analyte detection device according to claim 17, wherein: The transmitter, sensor and battery are located in the housing, and the memory and / or the processor are located in the external device.

20. The analyte detection device according to claim 17, wherein: At least two of the transmitter, the processor, or the memory are integrated into a same device.

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