Analyte detection device and detection method

Abstract

The application discloses an analyte detection device and a detection method. A first parameter value is acquired by a sensor, a set of prior data pairs of the first parameter value and a second parameter value is pre-stored in a memory, a processor calls the set of prior data pairs from the memory, and the second parameter value is acquired according to the first parameter value index. A preset calibration function is no longer needed to calculate the second parameter value according to the first parameter value, the error of the second parameter value is reduced, and the reliability of the analyte detection system is improved.

Description

[0001] Cross-reference to related applications

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

[0003] This invention relates primarily to the field of medical devices, and in particular to an analyte detection device and detection method. Background Technology

[0004] In a healthy person, the pancreas automatically monitors blood glucose levels and secretes the necessary insulin / glucagon. However, in diabetic patients, the pancreas malfunctions and cannot secrete insulin as needed. Therefore, diabetes is a metabolic disease caused by abnormal pancreatic function and is a lifelong condition. Currently, medical technology cannot cure diabetes; it can only control the occurrence and development of diabetes and its complications by stabilizing blood sugar levels.

[0005] Diabetic patients need to have their blood sugar checked before injecting insulin. Most current testing methods can continuously monitor blood sugar and send the data in real time to a remote device for user viewing; this method is called Continuous Glucose Monitoring (CGM). This method requires a testing device to be attached to the skin surface, with its probe inserted into the subcutaneous tissue fluid to complete the test.

[0006] Existing analyte detection devices are calibrated before or during use using a method that linearly adjusts the sensor sensitivity based on a priori calibration functions. However, in actual use, the sensor sensitivity does not change linearly, resulting in low reliability of the analyte parameter information detected by the sensor.

[0007] Therefore, there is an urgent need for a more reliable analyte detection device and method in the current technology. Summary of the Invention

[0008] This invention discloses an analyte detection device and method. A sensor acquires a first parameter value, and a priori data set of the first and second parameter values ​​is pre-stored in a memory. The processor retrieves the priori data set from the memory and obtains the second parameter value according to the index of the first parameter value. This eliminates the need for a preset calibration function to calculate the second parameter value based on the first parameter value, reducing the error of the second parameter value and improving the reliability of the analyte detection system.

[0009] This invention discloses an analyte detection device, comprising: a housing; a sensor including an in vivo portion and an external portion, the in vivo portion being inserted subcutaneously into a user to obtain a first parameter value; a memory pre-stored at least one prior data pair consisting of a first parameter value and a second parameter value, the second parameter value being associated with in vivo analyte parameter information; a processor programmed to retrieve the prior data pair from the memory, indexing the data pair based on the first parameter value to obtain the second parameter value; a transmitter for transmitting the first parameter value and / or the second parameter value to a remote device; and a battery for providing electrical energy.

[0010] According to one aspect of the present invention, the first parameter value is interpolated to obtain the second parameter value.

[0011] According to one aspect of the invention, the first parameter value is a current value or a voltage value.

[0012] According to one aspect of the invention, the second parameter value includes at least a blood glucose concentration value.

[0013] According to one aspect of the invention, the prior data set is at least partially derived from in vivo testing.

[0014] According to one aspect of the invention, the prior data set is at least partially derived from in vitro testing.

[0015] According to one aspect of the invention, at least some data pairs in the prior data pair set are adjustable.

[0016] According to one aspect of the invention, the adjustment of the data pair is at least partially based on differences in time parameters.

[0017] According to one aspect of the invention, the adjustment of the data pair is at least partially based on the physical characteristics of the sensor.

[0018] According to one aspect of the invention, the physical characteristics of the sensor include at least one of the following: membrane thickness, active enzyme area, active enzyme volume, or electrode resistance.

[0019] According to one aspect of the invention, the adjustment of the data pair is fixed.

[0020] According to one aspect of the invention, the adjustment of the data pairs is linear.

[0021] According to one aspect of the present invention, the first parameter value or the second parameter value is set with at least one threshold, and when the first parameter value or the second parameter value exceeds the threshold, the remote device issues an alarm indication.

[0022] According to one aspect of the invention, the threshold is set by a user or a non-user.

[0023] According to one aspect of the invention, the transmitter, memory, sensor, processor, and battery are located within a housing.

[0024] According to one aspect of the invention, the transmitter, sensor, and battery are located within the housing, while the memory and / or processor are located in a remote device.

[0025] According to one aspect of the invention, at least two of the transmitter, processor, or memory are integrated into the same device.

[0026] The present invention also discloses an analyte detection method, comprising: providing a memory, wherein the memory pre-stores at least one prior data pair consisting of a first parameter value and a second parameter value, the second parameter value being associated with in vivo analyte parameter information; a sensor, comprising an in vivo part and an external part, wherein the in vivo part is inserted subcutaneously into the user to obtain the first parameter value; a processor, wherein the processor is programmed to obtain the first parameter value from the sensor and simultaneously retrieve the prior data pair from the memory, indexing the data pair based on the first parameter value to obtain the second parameter value; and a transmitter, wherein the transmitter transmits the first parameter value and / or the second parameter value to a remote device.

[0027] According to one aspect of the present invention, the first parameter value is interpolated to obtain the second parameter value.

[0028] According to one aspect of the invention, the prior data set is at least partially derived from in vivo testing.

[0029] According to one aspect of the invention, the prior data set is at least partially derived from in vitro testing.

[0030] According to one aspect of the invention, at least some data pairs in the prior data pair set are adjustable.

[0031] According to one aspect of the invention, the adjustment of the data pair is at least partially based on differences in time parameters.

[0032] According to one aspect of the invention, the adjustment of the data pair is at least partially based on the physical characteristics of the sensor.

[0033] According to one aspect of the invention, the physical characteristics of the sensor include at least one of the following: membrane thickness, active enzyme area, active enzyme volume, or electrode resistance.

[0034] According to one aspect of the invention, the adjustment of the data pair is fixed.

[0035] According to one aspect of the invention, the adjustment of the data pairs is linear.

[0036] According to one aspect of the present invention, the first parameter value or the second parameter value is set with at least one threshold, and when the first parameter value or the second parameter value exceeds the threshold, the remote device issues an alarm indication.

[0037] According to one aspect of the invention, the threshold is set by a user or a non-user.

[0038] Compared with the prior art, the technical solution of the present invention has the following advantages:

[0039] In the analyte detection device disclosed in this invention, a sensor acquires a first parameter value, and a priori data set of the first parameter value and a second parameter value is pre-stored in the memory. The processor retrieves the priori data set from the memory and obtains the second parameter value according to the index of the first parameter value. This eliminates the need for a preset calibration function to calculate the second parameter value based on the first parameter value, reduces the error of the second parameter value, and improves the reliability of the analyte detection system.

[0040] Furthermore, the second parameter value is obtained by interpolation of the first parameter value, which avoids missing the index of the first parameter value and improves the reliability of the prior data set.

[0041] Furthermore, at least some data pairs in the prior data set can be adjusted based on the actual usage of the analyte detection device, such as usage time and sensor physical characteristics, to improve the accuracy of obtaining the second parameter value and enhance the reliability of the analyte detection system.

[0042] Furthermore, the adjustment of the data pairs can be fixed or linear, and can be flexibly adjusted according to actual needs to improve the accuracy of obtaining the second parameter value and improve the reliability of the analyte detection device.

[0043] Furthermore, the first or second parameter value is set with at least one threshold, such as a hyperglycemia and / or hypoglycemia threshold. When either parameter value exceeds the threshold, a hyperglycemia / hypoglycemia alarm will be triggered to alert the user to the risk of blood sugar deficiency, thereby improving the user experience.

[0044] Furthermore, having the memory and / or processor located in a remote device can increase the storage capacity of the memory and the computational capacity of the processor.

[0045] Furthermore, integrating at least two of the memory, processor, or transmitter into the same device helps reduce the device's footprint and facilitates the miniaturization of analyte detection devices. Attached Figure Description

[0046] Figure 1 This is a schematic diagram of the structure of an analyte detection system according to an embodiment of the present invention;

[0047] Figure 2This is a schematic diagram of the analyte detection device according to an embodiment of the present invention;

[0048] Figure 3a This is a schematic diagram of the structure of the wake-up module of the analyte detection device according to an embodiment of the present invention, including a photosensitive element;

[0049] Figure 3b 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 photosensitive element.

[0050] Figure 4a This is a schematic diagram of the structure of the analyte detection system according to an embodiment of the present invention, including a magnetic component and a magnetic sensing element;

[0051] Figure 4b This is a schematic diagram of the structure of the analyte detection device wake-up module including a magnetic sensing element according to an embodiment of the present invention;

[0052] 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.

[0053] Figure 5a This is a schematic diagram of the structure of an analyte detection system including an acceleration sensor according to an embodiment of the present invention;

[0054] Figure 5b This is a schematic diagram of the structure of the analyte detection device wake-up module including an acceleration sensor according to an embodiment of the present invention;

[0055] Figure 5c This is a functional schematic diagram of the wake-up module of the analyte detection device according to an embodiment of the present invention, which includes an acceleration sensor.

[0056] Figures 6a-6b These are schematic diagrams illustrating two structures of a sensor according to embodiments of the present invention;

[0057] Figure 7 This is a first data pair set according to an embodiment of the present invention;

[0058] Figure 8 This is a schematic diagram illustrating communication between an analyte detection device and a remote device according to an embodiment of the present invention;

[0059] Figure 9 This is a flowchart illustrating the use of a first data pair set according to an embodiment of the present invention;

[0060] Figure 10 This is a second data pair set according to an embodiment of the present invention;

[0061] Figure 11 This is a flowchart illustrating the use of the second type of data set according to an embodiment of the present invention.

[0062] Figure 12 This is a flowchart of a first calibration scheme according to an embodiment of the present invention;

[0063] Figure 13a This is an average data pair set according to an embodiment of the present invention;

[0064] Figure 13b This is a set of average range value data pairs according to an embodiment of the present invention;

[0065] Figure 14 This is a flowchart illustrating the second calibration scheme according to an embodiment of the present invention;

[0066] Figure 15a This is a flowchart illustrating the calibration process based on differences in sensor physical characteristics according to an embodiment of the present invention.

[0067] Figure 15b This is a schematic diagram of the visualization curve of the data set in the coordinate system according to an embodiment of the present invention;

[0068] Figure 16 This is a schematic diagram of a data pair set in the second calibration scheme according to an embodiment of the present invention;

[0069] Figure 17 This is a flowchart illustrating a first type of calibration based on time parameter differences according to an embodiment of the present invention.

[0070] Figure 18 This is a second flowchart of calibration based on time parameter differences according to an embodiment of the present invention. Detailed Implementation

[0071] As mentioned earlier, existing analyte detection devices are calibrated before or during use by linearly adjusting the sensor sensitivity based on a priori calibration functions. However, in actual use, the sensor sensitivity does not change linearly, resulting in low reliability of the analyte parameter information detected by the sensor.

[0072] To address this problem, the present invention provides an analyte detection device and method. A sensor acquires a first parameter value, and a priori data set of the first and second parameter values ​​is pre-stored in a memory. The processor retrieves the priori data set from the memory and obtains the second parameter value based on the index of the first parameter value. This eliminates the need for a preset calibration function to calculate the second parameter value based on the first parameter value, reducing the error of the second parameter value and improving the reliability of the analyte detection system.

[0073] 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, numerical expressions, and values ​​of the components and steps set forth in these embodiments should not be construed as limiting the scope of the invention.

[0074] Furthermore, it should be understood that, for ease of description, the dimensions of the various components shown in the accompanying drawings are not necessarily drawn to actual scale; for example, the thickness, width, length, or distance of some units may be enlarged relative to other structures.

[0075] The following description of exemplary embodiments is merely illustrative and is not intended to limit the invention or its application or use in any way. Techniques, methods, and apparatus known to those skilled in the art may not be discussed in detail herein, but where applicable, such techniques, methods, and apparatus should be considered part of this specification.

[0076] It should be noted that similar labels and letters in the following figures indicate similar items; therefore, once an item is defined or described in a figure, it will not need to be discussed further in the subsequent description of the figures.

[0077] Figure 1 This is a schematic diagram of the analyte detection system according to an embodiment of the present invention. The analyte detection system 10 includes an auxiliary installer 101 and an analyte detection device 102. The auxiliary installer 101 includes a housing 1011 and an auxiliary installation module 1012. In this embodiment, the auxiliary installation module 1012 is a ejection mechanism located inside the housing 1011. The analyte detection device 102 is located at the ejection end of the auxiliary installation module 1012. In use, the auxiliary installation module 1012 can quickly install the analyte detection device 102 onto the surface of the host skin.

[0078] Figure 2 This is a schematic diagram of the 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 part 10221 and an internal part 10222. The external part 10221, the transmitter 1023, the internal circuit 1024, the battery 1025, and the wake-up module 1026 are all located inside the housing 1021. The internal part 10222 passes through a through hole 10211 on the housing 1021 to the outside of the housing, so as to be inserted under the skin of the host to detect analyte parameter information. As those skilled in the art will understand, in order to insert the internal portion 10222 into the host's subcutaneous tissue, the through-hole 10211 is located on the side of the outer shell 1021 away from the outer shell 1011. Adhesive tape (not shown in the figure) is also provided on this side to adhere and fix the analyte detection device 102 to the host's skin surface. The external portion 10221 is electrically connected to the transmitter 1023 via internal circuitry 1024, enabling the transmission of analyte parameter information to a remote device.

[0079] Before use, the outer shell 1021 of the analyte detection device 102 and the outer shell 1011 of the auxiliary installer 101 can be releasably connected. Here, "releasable connection" means that the outer shell 1021 and the outer shell 1011 are connected together by means of buckles, clamps, etc. Under the action of the ejection mechanism of the auxiliary installation module 1012, the outer shell 1021 can be separated from the outer shell 1011.

[0080] When the sensor 1022 reaches the end of its service life, or the battery 1025 is depleted, or other factors cause the analyte detection device to fail, the user should remove the entire analyte detection device from the host's skin surface, discard it completely, and replace it with a new analyte detection device. This helps maintain the optimal condition of each component and improves the reliability of the analyte detection device.

[0081] When the analyte detection device 102 is installed on the host's skin surface and put into use, it needs to establish communication with remote devices such as PDM (Personal Diabetes Manager) and mobile phones to exchange data and transmit the detected analyte information data in the host to the remote devices.

[0082] As mentioned above, before the analyte detection device 102 formally establishes communication with the remote device, it is in a sleep state and transmits signals to the remote device at a first frequency. In this embodiment of the invention, the analyte detection device 102 transmits signals to the remote device at a lower first frequency in the sleep state to reduce battery power consumption. In a more preferred embodiment of the invention, the first frequency is 0 to 12 times / hour. In an even more preferred embodiment of the invention, the first frequency is 0 times / hour, that is, the analyte detection device 102 does not transmit signals to the remote device in the sleep state.

[0083] To enable the analyte detection device 102 in its dormant state to establish communication with a remote device, the wake-up module 1026 wakes up the analyte detection device 102 according to trigger conditions, putting it into working mode. It then transmits a signal to the remote device at a second frequency, and communication is established after the remote device responds. To facilitate convenient and real-time acquisition of 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 12–3600 times / hour. In a more preferred embodiment of the present invention, the second frequency is 30 times / hour.

[0084] Example 1

[0085] Photosensitive element

[0086] Figure 3a This is a schematic diagram of the structure 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 according to an embodiment of the present invention, including a photosensitive element.

[0087] In this embodiment of the 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 circuit state, and when there is a light beam, the photosensitive element 10261 is in a closed circuit state.

[0088] Combination Figure 1 and Figure 3b The transmitter 1023 is connected to the battery 1025 through the internal circuit 1024 to form a closed loop. A wake-up module 1026 is connected to the circuit. A photosensitive element 10261 is connected inside the wake-up module 1026. The trigger condition for the wake-up module 1026 is the change in light intensity received by the photosensitive element 10261.

[0089] In a preferred embodiment of the present invention, the trigger condition for the wake-up module 1026 is that the intensity of the light received by the photosensitive element 10261 changes from weak to strong.

[0090] In this embodiment of the 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 installer 101. The outer shell 1021 and the housing 1011 form a sealed, opaque space. Since the light-transmitting area 10211 of the outer shell 1021 is located at one end close to the housing 1011, no external light shines on the photosensitive element 10261. 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 remote device at a first frequency. After the analyte detection device 102 is installed on the surface of the host skin via the auxiliary installation module 1012, the outer shell 1021 is separated from the housing 1011. External light shines through the outer shell 1021 onto the photosensitive element 10261, which is in a closed-circuit state. The transmitter 1023 enters the working state, and the analyte detection device 102 transmits a signal to the remote device at a second frequency. After the remote device responds, communication is established, and analyte detection data is transmitted to the remote device.

[0091] In this embodiment of the invention, the outer shell 1021 is made of a light-transmitting material, such as one of polymethyl methacrylate (PMMA), polystyrene (PS), polycarbonate (PC) or poly4-methyl-1-pentene (TPX). The light transmittance of the above materials is 40% to 95%. After the outer shell 1021 is separated from the housing 1011, external light can pass through the outer shell 1021 to irradiate the photosensitive element 10261.

[0092] In other embodiments of the present invention, the housing 1021 includes a light-transmitting area 10211, the light transmittance of the light-transmitting area 10211 is higher than that of the housing 1021, so that more external light can irradiate the photosensitive element 10261, thereby increasing the light intensity variation of the photosensitive element 10261 and improving the reliability of the photosensitive element 10261.

[0093] In another embodiment of the present invention, the light-transmitting area 10211 includes at least one light-transmitting hole, or an array of multiple light-transmitting holes. The light-transmitting hole allows more external light to illuminate the photosensitive element 10261, further increasing the light intensity variation of the photosensitive element 10261 and improving its reliability. In a preferred embodiment of the present invention, a light-transmitting film (not shown in the figure) is provided in the light-transmitting hole to prevent external water droplets, dust, and other contaminants from entering the analyte detection device through the light-transmitting hole, thereby improving the device's reliability.

[0094] In this embodiment of the invention, the photosensitive element 10261 can sense visible light or invisible light, such as infrared or ultraviolet light. In a preferred embodiment of the invention, the photosensitive element 10261 senses visible light, so that the user can activate the analyte detection device whether indoors or outdoors.

[0095] In another embodiment of the present invention, the open-circuit / closed-circuit switching condition of the photosensitive element is the transition from weak light irradiation to strong light irradiation. That is, before the outer shell 1021 is separated from the housing 1011, weak external light is allowed to irradiate the inside of the housing 1011. The photosensitive element 10261 receives the weak light but remains in an open-circuit state, and the transmitter 1023 is in a dormant state. This is because the actual connection between the outer shell 1021 and the housing 1011 is not completely sealed. After the outer shell 1021 is separated from the housing 1011, external light shines on the photosensitive element 10261 through the outer shell 1021 or the light-transmitting area 10211. The intensity of the light received by the photosensitive element 10261 increases. After reaching the set light intensity threshold, the photosensitive element 10261 switches to a closed-circuit state, and the transmitter 1023 enters the working state, transmitting a signal to the remote device at a second frequency. After the remote device responds, communication is established, and analyte detection data is transmitted to the remote device.

[0096] Example 2

[0097] Magnetic components and magnetic sensing elements

[0098] Figure 4a This is a schematic diagram of the structure of the analytical substance detection system according to an embodiment of the present invention, including a magnetic component and a magnetic sensing element. Figure 4b This is a schematic diagram of the structure of the wake-up module of the analyte detection device according to an embodiment of the present invention, which includes 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.

[0099] In this embodiment of the invention, a magnetic element 203 is disposed on the housing 2011, and a magnetic sensing element 20261 is disposed within the wake-up module 2026. The magnetic element 203 provides a stable magnetic field, and the magnetic sensing element 20261 is located within the magnetic field of the magnetic element 203 and senses the magnetic field of the magnetic element 203 to generate a signal. The trigger condition for the wake-up module 2026 is the change in the magnetic field sensed by the magnetic sensing element 20261.

[0100] The transmitter 2023 is connected to the battery 2025 via an internal circuit 2024, forming a closed loop. A wake-up module 2026 is connected to the circuit, and the battery 2025 supplies power to the transmitter 2023 through the wake-up module 2026 (including the magnetic sensing element 20261). Before the analyte detection device 202 is installed on the host's skin surface, the analyte detection device 202 is not separated from the auxiliary installer 201, and its relative position is fixed. The magnetic sensing element 20261 senses that the magnetic field of the magnetic component 203 is stable. Under a stable magnetic field, the magnetic sensing element 20261 is in an open-circuit state, the transmitter 2023 is in a dormant state, and the analyte detection device 202 transmits a signal to a remote device at a first frequency. After the analyte detection device 202 is installed on the surface of the host skin via the auxiliary installation module 2012, the outer shell 2021 separates from the housing 2011, the distance between the magnetic sensing element 20261 and the magnetic component 203 changes, and therefore the sensed magnetic field also changes. The magnetic sensing element 20261 switches to a closed-circuit state, the transmitter 2023 enters the working state, the analyte detection device 202 transmits a signal to the remote device at a second frequency, establishes communication after the remote device responds, and transmits analyte detection data to the remote device.

[0101] In this embodiment of the invention, the magnetic sensing element 20261 senses the magnetic field strength or direction of the magnetic element 203. Preferably, the magnetic sensing element 20261 includes a Hall element (not shown in the figure), which can sensitively sense changes in the magnetic field strength of the magnetic element 203.

[0102] In this embodiment of the invention, the magnetic component 203 may be an individual part independent of the housing 2011, or it may be a part of the housing 2011 and embedded in the housing 2011.

[0103] In other embodiments of the present invention, the housing 2011 is embedded within or enclosed with a magnetic field shielding device (not shown in the figure), such as a Faraday cage. Those skilled in the art will understand that the magnetic field shielding device is located outside the magnetic component 203 to reduce the influence of external magnetic fields on the magnetic sensing element 20261.

[0104] Example 3

[0105] Accelerometer

[0106] Figure 5aThis is a schematic diagram of the structure of the wake-up module of the analyte detection system according to an embodiment of the present invention, which includes an acceleration sensor. Figure 5b This is a schematic diagram of the structure of the wake-up module of the analyte detection device according to an embodiment of the present invention, which includes an acceleration sensor. Figure 5c This is a functional diagram of the wake-up module of the analyte detection device according to an embodiment of the present invention, which includes an acceleration sensor.

[0107] In this embodiment of the invention, the wake-up module 3026 includes an accelerometer 30261, which can sensitively sense motion parameter values ​​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.

[0108] The transmitter 3023 is connected to the 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 through the wake-up module 3026 (including an accelerometer 30261). Before the analyte detection device 302 is installed on the host's skin surface, the analyte detection device 302 and the auxiliary installer 301 are kept relatively fixed. In order to insert the internal part 30222 of the analyte detection device sensor into the host's subcutaneous tissue and reduce the pain during insertion, the auxiliary installer 3012 uses an ejection mechanism 30121, such as a spring or other elastic element, which allows the internal part 30222 to be quickly inserted into the host's subcutaneous tissue via the auxiliary needle 30122. When in use, the ejection mechanism 30121 generates a large instantaneous positive acceleration a1. After being installed on the surface of the host's skin, it generates a reverse acceleration a2 due to the obstruction of the skin. After the acceleration sensor 30261 senses the above two accelerations, it can determine that the analyte detection device 302 has been installed on the surface of the host's skin.

[0109] In this embodiment of the invention, before the analyte detection device 302 is installed on the host skin surface, the wake-up module 3026 is in an open-circuit state, and the transmitter 3023 is in a dormant state. The analyte detection device 302 transmits a signal to a remote device at a first frequency. After the accelerometer sensor 30261 determines that the analyte detection device 302 has been installed on the host skin surface, the wake-up module 3026 switches to a closed-circuit state, the transmitter 3023 enters the working state, and the analyte detection device 302 transmits a signal to the remote device at a second frequency. After the remote device responds, communication is established, and analyte detection data is transmitted to the remote device.

[0110] Continue to refer to Figure 2In this embodiment of the invention, the sensor 1022 includes an external portion 10221 and an internal portion 10222. The external portion 10221 lies flat inside the housing 1021, which reduces the height of the sensor and thus reduces the thickness of the analyte detection system. The internal portion 10222 is bent relative to the external portion 10221 and passes through a through-hole 10211 on the housing to the outside.

[0111] In a preferred embodiment of the present invention, the in vivo portion 10222 is bent at 90° relative to the external portion 10221.

[0112] In this embodiment of the invention, the internal part 10222 is inserted under the skin of the user to obtain a first parameter value, and the external part 10221 is electrically connected to the internal circuit 1024.

[0113] Figure 6a , Figure 6b These are schematic diagrams of two sensor structures according to embodiments of the present invention.

[0114] refer to Figure 6a In this embodiment of the invention, the internal part 10222 includes two electrodes, namely 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 disposed on the external part 10221 and electrically connected to the internal circuit 1024. The electrodes, wires, and pins are all fixed on an insulating substrate.

[0115] refer to Figure 6b In this embodiment of the invention, the in vivo 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 disposed on the external portion 10221 and electrically connected to the internal circuit 1024. The electrodes, wires, and pins are all fixed on an insulating substrate.

[0116] In this embodiment of the invention, an active enzyme layer capable of reacting with an in vivo analyte is further disposed 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 in vivo glucose, the reaction occurs according to the in vivo glucose concentration f(x). n Different values ​​of the second parameter will produce different numbers of electrons, resulting in different current or voltage values ​​x at the electrodes. n (First parameter value). That is, a priori data pair of first and second parameter values ​​can be obtained, and when using sensor 1022, the second parameter value is inferred from the first parameter value. In a preferred embodiment of the present invention, the first parameter value is the current value of sensor 1022.

[0117] In other embodiments of the present invention, the in vivo analyte may also be other in vivo substances such as adrenaline, thyroid hormone, and hemoglobin, and there are no limitations on this.

[0118] In other embodiments of the present invention, the second parameter value may also be other parameters of the analyte in vivo, such as the type of analyte.

[0119] In some embodiments of the present invention, prior data pairs of the first and second parameter values ​​can be obtained through in vitro testing. For example, the sensor 1022 is placed in different concentrations f(x) n In the analyte solution containing the second parameter value, a standard operating voltage is provided, and the feedback current value x of sensor 1022 is measured. n (First parameter value), resulting in the following: Figure 7 The first type of data set is shown.

[0120] In other embodiments of the present invention, prior data pairs of the first and second parameter values ​​can be obtained through in vivo testing. For example, the sensor 1022 is inserted into the user's body, a standard operating voltage is provided, and the in vivo concentration f(x) of the analyte is obtained using methods such as finger-prick blood. n (Second parameter value), and simultaneously measure the feedback current value x of sensor 1022. n (First parameter value), thus obtaining the data pair set. When obtaining prior data pairs through in vivo testing, the interference of other analytes and environmental factors on the first parameter value can be eliminated, resulting in a higher accuracy of the prior data pair set obtained from the test.

[0121] In some other embodiments of the present invention, the prior data set of the first parameter value and the second parameter value can be obtained partly in vivo and partly in vitro.

[0122] In a preferred embodiment of the present invention, the prior data set of the first parameter value and the second parameter value is obtained through in vitro testing. During in vitro testing, the accuracy and range of the second parameter value can be manually controlled, thereby obtaining a data set with higher accuracy and a wider range.

[0123] In some embodiments of the present invention, the analyte concentration f(x) is preset during testing. n The concentration 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, etc., and the current values ​​x1, x2, etc. of sensor 1022 at the corresponding concentrations are obtained respectively, thus obtaining a set of 1201 data pairs. In some other embodiments of the present invention, the analyte concentration f(x1, x2, ...) is preset during testing. nThe concentration 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 so on. The current values ​​x1, x2, etc. of sensor 1022 at the corresponding concentrations are obtained, resulting in a set of 191 data pairs. Considering the storage space of the analyte detection system and the actual usage requirements, different test ranges and test accuracies can be set.

[0124] In this embodiment of the invention, after obtaining the data set of the first parameter value and the second parameter value, the data set is input into the memory of the analyte detection system for retrieval and indexing during use.

[0125] Figure 8 This is a schematic diagram of an analyte detection system. Figure 9 This is a flowchart illustrating the usage of the first data set in the analyte detection system.

[0126] Combined with reference Figure 2 , Figure 8 and Figure 9 In some embodiments of the present invention, a priori data set is stored in memory 1027. After sensor 1022 is inserted under the user's skin, it acquires a first parameter value (current value) and inputs the first parameter value to processor 1028. Processor 1028 retrieves the priori data set from memory 1027, obtains a second parameter value based on the current value index acquired by sensor 1022, and obtains the in vivo analyte concentration. Then, it is transmitted by transmitter 1023 to a remote device for user reference.

[0127] Considering the limited size of the internal circuit 1024, the size of the memory 1027 and the processor 1028 is also limited, making it impossible to store large amounts of data pairs or perform large amounts of data processing. In other embodiments of the present invention, the memory 1027 and the processor 1028 are located in a remote device, such as a handheld device, mobile phone, or computer. After the sensor 1022 acquires the current value, it is sent by the transmitter 1023 to the processor 1028 in the remote device. The processor 1028 retrieves the prior data pair from the memory 1027, obtains the second parameter value based on the current value index acquired by the sensor 1022, and obtains the in vivo analyte concentration for user reference.

[0128] In some further embodiments of the invention, the memory 1027 is located in a remote device, and the processor 1028 is located in a local internal circuit 1024. In some further embodiments of the invention, the processor 1028 is located in a remote device, and the memory 1027 is located in a local internal circuit 1024.

[0129] In some embodiments of the present invention, the memory 1027 and the processor 1028 can be integrated into the same electronic device, such as a CPU or MCU. In some embodiments of the present invention, the processor 1028 and the transmitter 1023 can be integrated into the same electronic device, such as a radio frequency chip. In some embodiments of the present invention, the memory 1027 and the transmitter 1023 can be integrated into the same electronic device. In some embodiments of the present invention, the transmitter 1023, the memory 1027, and the processor 1028 can be integrated into the same electronic device.

[0130] In other embodiments of the present invention, the indexing function of the processor 1028 can also be implemented in hardware, for example, by a filter composed of multiple comparators with different high and low thresholds. Each comparator is connected to a transmitter, and the transmitter's transmitted signal is a preset signal associated with blood glucose concentration information (second parameter value) or current value information (first parameter value). When the sensor 1022 acquires current, the current enters the filter. Currents of different intensities can only pass through comparators with high thresholds higher than their values ​​and low thresholds lower than their values. At the same time, the transmitter connected to the comparator is activated, and the transmitter sends the preset signal to a remote device.

[0131] Considering that the prior data set is discrete, in some cases, the current value of sensor 1022 may not exist in the prior data set, causing the processor 1028 to fail to index and thus be unable to obtain the corresponding analyte concentration value. To address this, in a preferred embodiment of the invention, the processor 1028 performs an interpolation operation during indexing. For example, when the current value detected by sensor 1022 is x, this x value may not exist in the prior data set, but it may be located between two adjacent first parameter values ​​x already recorded in the prior dataset. -1 and x +1 Therefore, the analyte concentration f(x) corresponding to the current value x can be calculated using interpolation:

[0132]

[0133] In this embodiment of the invention, the higher the precision of the prior data set, the higher the accuracy of the result obtained by interpolation.

[0134] In response to the situation where the processor 1028 index fails, in a preferred embodiment of the present invention, the analyte concentration f(x) is preset during testing. nThe range of concentration 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, etc. The current values ​​x1, x2, etc. of sensor 1022 at the corresponding concentrations are obtained. When setting the prior logarithm set, the first parameter value is set to the range of the average of 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 is important to note the difference between the analyte concentration values ​​f(x1) at the head of the dataset and f(x2) at the tail of the dataset. n The corresponding current values ​​are respectively and Get as Figure 10 The second type of data set is shown. In this data set, the first parameter value is continuous, and there will be no missing indexes. For example, when the current value detected by sensor 1022 is x, processor 1028 determines that the value satisfies... Then the analyte concentration at this time can be obtained by indexing f(x) 299 ).

[0135] Figure 11 This is a flowchart illustrating the use of the second type of data set in the analyte detection system.

[0136] In this embodiment of the invention, the memory 1027 stores a priori data set. After the sensor 1022 is inserted under the user's skin, it obtains a first parameter value (current value) and inputs the first parameter value to the processor 1028. The processor 1028 retrieves the priori data set from the memory 1027 and determines the range in which the first parameter value falls. Based on the index of the range in which the first parameter value falls, it obtains a second parameter value and obtains the in vivo analyte concentration information.

[0137] Based on market demand, and considering that the 1022 sensor needs to be mass-produced and used—with potentially thousands or even tens of thousands of sensors in the same batch—and that each sensor's manufacturing parameters and physical characteristics will not be exactly the same, performing high-precision testing on each sensor, such as 1201 tests per sensor, would consume a significant amount of production time for manufacturers. Therefore, a highly efficient sensor calibration scheme is needed.

[0138] Figure 12 This is a flowchart of the first calibration scheme according to an embodiment of the present invention.

[0139] In this embodiment of the invention, m samples are taken from a batch of sensors, for example, 10,000 sensors, for testing, and data sets of each sample are obtained. The first test parameter value for all sample data pairs The average value of the first test parameter is obtained by averaging. Then average the first test parameter value of the sample. Assigning it as the first parameter value for all sensors in this batch, we get the following: Figure 13a The average data pairs shown This average data set serves as the prior data set for this batch of sensors and is input into memory 1027.

[0140] In this embodiment of the invention, m can be selected as 1 / 1000, 1 / 100, 1 / 50, 1 / 20, or 1 / 10 of the number of sensors in the same batch. The more samples taken, the higher the accuracy of the average data set, but the more testing time is required. In a preferred embodiment of the invention, m is selected as 1 / 50 of the number of sensors in the same batch.

[0141] Considering that the average first parameter value assigned to a batch of sensors is discrete, the processor 1028 may also experience index failures.

[0142] In some embodiments of the present invention, the processor 1028 needs to perform an interpolation operation when indexing. For example, when the current value detected by the sensor 1022 is x, this value x does not exist in the prior data pair set, but the value is located between two adjacent average first parameter values ​​already recorded in the prior dataset. and Therefore, the analyte concentration f(x) corresponding to the current value x can be calculated using interpolation:

[0143]

[0144] In other embodiments of the present invention, when setting the prior data set, the first parameter value of the batch sensors is set to a range of values ​​formed by the average of 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 is important to note the difference between the analyte concentration values ​​f(x1) at the head of the dataset and f(x2) at the tail of the dataset. n The corresponding current values ​​are respectively and Get as Figure 13b The data set shown is an average range of values. In this data set, the average first test parameter value is continuous, and there will be no index gaps. For example, when sensor 1022 detects a current value of x, processor 1028 determines that the value meets the following conditions. Then the analyte concentration at this time can be obtained by indexing f(x) 299 ).

[0145] Figure 14 This is a flowchart of the second calibration scheme according to an embodiment of the present invention.

[0146] Considering that in the sample calibration scheme, manufacturers still need to perform high-precision testing on a large number of samples, which will still consume a significant amount of production time, in this embodiment of the invention, a batch (e.g., i) of sensors can be tested before production to obtain a batch prior data set including a first test parameter value and a second parameter value. The number of sensors in the batch, i, can be 100, 1000, 10000, or more. A larger number facilitates subsequent classification and partitioning of the data sets. Because the second parameter value is consistent during sensor testing, the batch prior data sets are summarized based on the first test parameter value to obtain the summarized dataset D. i :

[0147]

[0148] The above summarized data set D i The datasets are categorized and divided using either the hold-out method or cross-validation, resulting in j typical dataset sets D. j :

[0149]

[0150] In this embodiment of the invention, the j typical data pair sets can be 10, 20, 50, 100, or more. A larger number of typical data pair sets indicates more accurate data pair classification, but also results in a greater computational load. The aforementioned j typical data pair sets D... j It can characterize the data sets of all sensors.

[0151] In this embodiment of the invention, a typical data pair set D is obtained. j Then, the above typical data will be compared with set D. j The data is stored in the computer on the production line. During formal production, only z data pairs of the sensors to be shipped need to be tested. Select the set of typical data pairs that are closest to the z data pairs. This data is for the set The prior data set for the sensor to be shipped is stored in the memory 1027 corresponding to that sensor. Compared to the sample calibration scheme, the typical data set calibration scheme can further save production time and improve production efficiency during production.

[0152] In this embodiment of the invention, the set of typical data pairs closest to the z data pairs can be obtained by minimizing the sum of squared differences. That is, the first test parameter values ​​of the z data pairs are... The data is input into the computer, and the computer will input the z first test parameter values. Substitute them into j typical data pairs D respectively j The calculation is performed to obtain... Typical datasets The most closely related typical data set is the one that can most approximate the actual data set of the sensor to be shipped. At the same time, the computer inputs the typical data set into the memory corresponding to the sensor to be shipped, as the prior data set of the sensor to be shipped.

[0153] In this embodiment of the invention, the z data pairs to be 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, but this also results in more production time and more computation.

[0154] Figure 15a This is a flowchart illustrating the calibration process based on differences in sensor physical characteristics according to an embodiment of the present invention. Figure 15b This is a schematic diagram of the data set in the coordinate system as described in an embodiment of the present invention.

[0155] Considering the differences in physical characteristics between sensors, such as membrane thickness, active enzyme layer area, active enzyme layer volume, or electrode resistance, the actual data set of the sensor to be shipped will have a fixed or linear difference compared to the closest typical data set or other prior data sets. Figure 15b As shown. In Figure 15b In the middle, curve and Characterizing the actual data set of the sensor to be shipped, curve The set of most closely related typical data pairs Compared to There is a fixed difference. Compared to There is a linear difference.

[0156] Continue to refer to Figure 15a In this embodiment of the invention, the closest set of typical data pairs is found among the sensors to be shipped. Next, the z test data pairs are compared with the typical data pair set to see if there is a fixed difference or a linear difference. If no difference exists, the typical data pair set is then... Input into memory; if differences exist, then a typical data pair set needs to be processed. The first parameter value is adjusted to minimize the difference between the typical data set and the actual data set, and the adjusted data set is then used. Input into memory.

[0157] In this embodiment of the invention, typical data pairs are used. The value of the first parameter can be adjusted by the adjustment function x. t accomplish:

[0158] xt = a*x + b

[0159] In the formula,

[0160] 'a' is the linear adjustment coefficient;

[0161] b is a fixed adjustment factor;

[0162] x is the first parameter value in the set of typical data pairs before adjustment.

[0163] In this embodiment of the invention, the fixed adjustment coefficient b is calculated from the fixed difference between the actual data set and the typical data set of the sensor. The linear adjustment coefficient a is calculated from the linear difference between the actual data set and the typical data set of the sensor.

[0164] Figure 16 This is a schematic diagram of the data pair set in the second calibration scheme of this invention.

[0165] In this embodiment of the invention, the z data pairs of the sensor to be tested before leaving the factory are selected using an equidistant distribution, such as... Figure 16 As shown.

[0166] In other embodiments of the present invention, z data pairs for testing the sensor to be shipped are selected using a random distribution.

[0167] Considering that during the use of the analyte detection system, as the usage time increases, due to factors such as changes in the activity of the sensor enzyme layer and electrode oxidation, the prior data set deviates from the actual data set of the sensor, and this deviation will continue to change, storing a fixed prior data set in the memory cannot meet the long-term use requirements of the sensor.

[0168] Figure 17 This is a flowchart of the first type of calibration based on time parameter differences in an embodiment of the present invention.

[0169] In this embodiment of the invention, the sensor to be shipped is tested at time t0 to obtain the first prior data set D at time t0. t0 Then, perform another test at time t1 to obtain the second prior data pair set D at time t1. t1This process is repeated to obtain multiple sets of prior data pairs based on differences in time parameters, which are then input into the memory corresponding to the sensor to be shipped. Simultaneously, the processor is programmed to retrieve the first set of prior data pairs D from memory during the time interval t0-t1. t0 After the sensor acquires the first parameter value, the processor processes the first prior data set D. t0 The second parameter value is obtained based on the index of the first parameter value; the second prior data pair D is retrieved from memory during time t1-t2. t1 After the sensor acquires the first parameter value, the processor processes the second prior data set D. t1 The second parameter value is obtained based on the index of the first parameter value... until the sensor's lifespan ends or the analyte detection device stops working.

[0170] In this embodiment of the invention, the number of prior data pairs input to the memory is determined by the test interval time Δt and the sensor's lifespan T. For example, when the sensor's lifespan T is 14 days and the test interval time Δt is 1 day, the number of prior data pairs is T / Δt = 14.

[0171] In some embodiments of the present invention, multiple sets of prior data pairs based on differences in time parameters can be as follows: Figure 7 Or such as Figure 13a The data sets shown are indexed using interpolation when in use.

[0172] In some embodiments of the present invention, multiple sets of prior data pairs based on differences in time parameters can also be as follows: Figure 10 Or such as Figure 13b The data set shown is indexed based on the range in which the first parameter value falls when used.

[0173] In some embodiments of the present invention, multiple sets of prior data pairs based on differences in time parameters can also be as follows: Figure 16 The typical data sets shown are set with j typical data sets in time periods such as t0-t1, t1-t2, and t2-t3. Then, through calculation, the typical data set that is closest to the sensor to be shipped is found in each time period and stored in the memory 1027 corresponding to the sensor. Correspondingly, the processor 1028 is programmed to retrieve the typical data sets for indexing in each time period.

[0174] Figure 18 This is a second flowchart of the calibration based on time parameter differences in an embodiment of the present invention.

[0175] In this embodiment of the invention, the memory 1027 also stores a priori calibration function f(x) based on the difference in time parameters. t :

[0176] f(x)t = f(x) + a(t)*x + c,

[0177] in,

[0178] f(x) t The adjusted value of the second parameter;

[0179] f(x) is the value of the second parameter before adjustment;

[0180] a(t) is the prior calibration proportionality coefficient, which is related to the sensor's usage time;

[0181] c is the prior calibration constant.

[0182] In some embodiments of the present invention, the prior calibration proportionality coefficient and the prior calibration constant are obtained through testing of the sensors to be shipped. In other embodiments of the present invention, the prior calibration proportionality coefficient and the prior calibration constant are obtained by sampling a batch of sensors, and then the sample data is averaged and assigned to the batch of sensors.

[0183] Reference Figure 18 In this embodiment of the invention, when using the analyte detection system, sensor 1022 acquires 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. It first indexes the data pair set based on the first parameter value to obtain a second parameter value, and then adjusts the obtained second parameter value through the priori calibration function to obtain the adjusted second parameter value, which is then sent to a remote device.

[0184] In other embodiments of the present invention, sensor 1022 acquires 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. It first retrieves a second parameter value by indexing the data pair set based on the first parameter value and outputs it to a remote device. Then, it adjusts the data pair set according to the priori calibration function and stores the adjusted data pair set in memory 1027 as the data pair set to be retrieved in the next detection cycle. In some embodiments of the present invention, the adjustment of the data pair set involves adjusting the first parameter value while keeping the second parameter value unchanged. In other embodiments of the present invention, the adjustment of the data pair set involves simultaneously adjusting both the first and second parameter values. In still other embodiments of the present invention, the adjustment of the data pair set involves adjusting the second parameter value while keeping the first parameter value unchanged.

[0185] Reference Figure 7 , Figure 9 , Figure 10 , Figure 11 , Figure 13a , Figure 13b , Figure 17 and Figure 18 In this embodiment of the invention, the processor 1028 is configured with a first parameter threshold, corresponding to a first parameter value, such as a current threshold or a voltage threshold. This first parameter threshold includes a high threshold (higher value) and a low threshold (lower value), with the region between the high and low thresholds considered a normal range. When the sensor 1022 acquires 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 hyperglycemia or hypoglycemia, it outputs an alarm indication.

[0186] In other embodiments of the present invention, the processor 1028 is configured with a second parameter threshold, corresponding to a second parameter value, such as a blood glucose concentration threshold. This second parameter threshold includes a higher high threshold and a lower low threshold, with the region between the high and low thresholds considered a normal range. When the processor 1028 retrieves the second parameter value, it 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 hyperglycemia or hypoglycemia, it outputs an alarm indication.

[0187] In this embodiment of the invention, the alarm indication can be processed by the local internal circuit 1024 or by a remote device. After the alarm indication is processed, it is alerted to the user or other monitoring personnel in one or more forms such as light emission, sound emission, and vibration.

[0188] In this embodiment of the invention, the first parameter threshold or the second parameter threshold in the processor 1028 can be set by the 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 it can be set by another guardian.

[0189] In summary, the present invention provides an analyte detection device and detection method. A sensor acquires a first parameter value, and a priori data pair of the first and second parameter values ​​is pre-stored in a memory. The processor retrieves the priori data pair from the memory and obtains the second parameter value according to the index of the first parameter value. This eliminates the need for a preset calibration function to calculate the second parameter value based on the first parameter value, reduces the error of the second parameter value, and improves the reliability of the analyte detection system.

[0190] While specific embodiments of the invention have been described in detail by way of examples, those skilled in the art should understand that the above examples are for illustrative purposes only and are not intended to limit the scope of the invention. Those skilled in the art should understand that modifications can be made to the above embodiments without departing from the scope and spirit of the invention. The scope of the invention is defined by the appended claims.

Claims

1. An analyte detection device, characterized in that, include: shell; The sensor includes an internal part and an external part. The internal part is used to be inserted under the skin of the user to obtain a first parameter value. During use, the sensitivity of the sensor changes non-linearly. The memory pre-stores at least one set of prior data pairs consisting of the first parameter value and the second parameter value, as well as a prior calibration function based on the time parameter difference, wherein the second parameter value is associated with in vivo analyte parameter information. A processor is programmed to retrieve the prior data pair set and the prior calibration function from the memory, index the data pair set based on the first parameter value to obtain the second parameter value, and adjust the prior data pair set using the prior calibration function for the next detection retrieval. A transmitter, the transmitter being used to send the first parameter value and / or the second parameter value to a remote device; and A battery, the battery being used to provide electrical energy; wherein the prior calibration function f(x) based on the time parameter is t f(x) = a + bx + cx2+ dx3 f(x) t = f(x) + a(t) * x + c f(x) t is the adjusted second parameter value; f(x) is the second parameter value before adjustment; a(t) is a priori calibration scale factor related to the usage time of the sensor; c is a priori calibration constant.

2. The analyte detection device according to claim 1, characterized in that, The first parameter value is interpolated to obtain the second parameter value.

3. The analyte detection device according to claim 1, characterized in that, The first parameter value is either a current value or a voltage value.

4. The analyte detection device according to claim 1, characterized in that, The second parameter value includes at least the blood glucose concentration value.

5. The analyte detection device according to claim 1, characterized in that, The prior data set is at least partially derived from in vivo testing.

6. The analyte detection device according to claim 1, characterized in that, The prior data set is at least partially derived from in vitro testing.

7. The analyte detection device according to claim 1, characterized in that, At least some of the data pairs in the prior data set are adjustable.

8. The analyte detection device according to claim 7, characterized in that, The adjustment of the data pairs is at least partially based on differences in time parameters.

9. The analyte detection device according to claim 7, characterized in that, The adjustment of the data pair is at least in part based on the physical characteristics of the sensor.

10. The analyte detection device according to claim 9, characterized in that, The physical characteristics of the sensor include at least one of the following: membrane thickness, active enzyme area, active enzyme volume, or electrode resistance.

11. The analyte detection device according to claim 7, characterized in that, The adjustment of the data pairs is fixed.

12. The analyte detection device according to claim 7, characterized in that, The adjustment of the data pairs is linear.

13. The analyte detection device according to claim 1, characterized in that, The first parameter value or the second parameter value is set with at least one threshold. When the first parameter value or the second parameter value exceeds the threshold, the remote device issues an alarm indication.

14. The analyte detection device according to claim 13, characterized in that, The threshold is set by the user or a non-user.

15. The analyte detection device according to claim 1, characterized in that, The transmitter, memory, sensor, processor, and battery are located within the housing.

16. The analyte detection device according to claim 1, characterized in that, The transmitter, sensor, and battery are located within the housing, while the memory and / or the processor are located in the remote device.

17. The analyte detection device according to claim 1, characterized in that, At least two of the transmitter, the processor, or the memory are integrated into the same device.

18. A method for detecting an analyte, characterized in that, include: supply The memory pre-stores at least one set of prior data pairs consisting of a first parameter value and a second parameter value, as well as a prior calibration function based on the time parameter difference, wherein the second parameter value is associated with in vivo analyte parameter information; The sensor includes an internal part and an external part. The internal part is inserted under the skin of the user to obtain the first parameter value. During use, the sensitivity of the sensor changes non-linearly. A processor is programmed to acquire the first parameter value from the sensor, simultaneously retrieve the prior data set and the prior calibration function from the memory, index the data set based on the first parameter value to obtain the second parameter value, and adjust the prior data set using the prior calibration function for the next detection retrieval. A transmitter that sends the first parameter value and / or the second parameter value to a remote device; Wherein, the prior calibration function f(x) based on the time parameter... t for: f(x) t =f(x)+a(t)*x+c f(x) t is the adjusted value of the second parameter; f(x) is the original value of the second parameter; a(t) is the prior calibration proportional coefficient, which is related to the sensor's usage time; c is the prior calibration constant.

19. The analyte detection method according to claim 18, characterized in that, The first parameter value is interpolated to obtain the second parameter value.

20. The analyte detection method according to claim 18, characterized in that, The prior data set is at least partially derived from in vivo testing.

21. The analyte detection method according to claim 18, characterized in that, The prior data set is at least partially derived from in vitro testing.

22. The analyte detection method according to claim 18, characterized in that, At least some of the data pairs in the prior data set are adjustable.

23. The analyte detection method according to claim 22, characterized in that, The adjustment of the data pairs is at least partially based on differences in time parameters.

24. The analyte detection method according to claim 22, characterized in that, The adjustment of the data pair is at least in part based on the physical characteristics of the sensor.

25. The analyte detection method according to claim 24, characterized in that, The physical characteristics of the sensor include at least one of the following: membrane thickness, active enzyme area, active enzyme volume, or electrode resistance.

26. The analyte detection method according to claim 22, characterized in that, The adjustment of the data pairs is fixed.

27. The analyte detection method according to claim 22, characterized in that, The adjustment of the data pairs is linear.

28. The analyte detection method according to claim 18, characterized in that, The first parameter value or the second parameter value is set with at least one threshold. When the first parameter value or the second parameter value exceeds the threshold, the remote device issues an alarm indication.

29. The analyte detection method according to claim 28, characterized in that, The threshold is set by the user or a non-user.

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