Analyte detection device with compressible glue

Abstract

The utility model discloses an analysis object detection device with compressible glue, including capacitive sensor and compressible glue, capacitive sensor sets up inside analysis object detection device, compressible glue sets up below analysis object detection device, and capacitive sensor is used for detecting the capacitance between skin, and then determines whether analysis object sensor is oppressed, when analysis object detection device is oppressed, compressible glue is compressed, compared with prior art scheme, the distance between skin and capacitive sensor changes greatly, leading to the capacitance that capacitive sensor detects changes significantly, can timely and accurately detect that analysis object detection device is oppressed.

Description

Technical Field

[0001] This utility model mainly relates to the field of medical devices, and in particular to an analytical device with a compressible adhesive. Background Technology

[0002] 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.

[0003] Diabetic patients need to have their blood sugar checked before injecting insulin. Currently, most methods involve using a continuous glucose monitoring (CGM) device inserted under the skin to continuously monitor blood sugar and transmit the data in real-time to a remote device. This provides users with continuous, real-time blood sugar data for easy viewing and provides more information for diabetes treatment. CGMs are typically worn on the upper arm or waist. If the user sleeps on their side or leaning back, it may compress the CGM, causing it to fail to monitor blood sugar properly, resulting in seriously erroneous or missing blood sugar values, affecting the user's diabetes treatment. In particular, if the user experiences high or low blood sugar while the CGM is compressed, the CGM will not be able to issue a high or low blood sugar alarm, further jeopardizing the user's life.

[0004] The prior art CN117045247A discloses a method of detecting pressure by detecting the capacitance value formed between the skin and the capacitive sensor. However, the capacitive sensor is set on the bottom shell or on a PCB board parallel to the bottom shell. Regardless of its location, since the shell of the CGM is made of rigid material, the distance between the capacitive sensor and the skin does not change or changes very little when pressure occurs. Therefore, the capacitance does not change or changes very little. Thus, this solution cannot detect the pressure on the CGM in a timely and accurate manner.

[0005] Therefore, there is an urgent need for an analytical device that can detect pressure in a timely and accurate manner. Utility Model Content

[0006] This utility model discloses an analyte detection device with a compressible adhesive, including a capacitive sensor and a compressible adhesive. The capacitive sensor is disposed inside the analyte detection device, and the compressible adhesive is disposed below the analyte detection device. The capacitive sensor is used to detect the capacitance value between itself and the skin, thereby determining whether the analyte sensor is under pressure. When the analyte detection device is under pressure, the compressible adhesive is compressed. Compared with the prior art, the distance between the skin and the capacitive sensor changes significantly, resulting in a significant change in the capacitance detected by the capacitive sensor, which can detect the analyte detection device being under pressure in a timely and accurate manner.

[0007] This utility model discloses an analyte detection device, comprising: a sensor assembly including a sensor inserted under the skin for detecting a user's blood glucose level; a transmitter assembly operably electrically connected to the sensor assembly for receiving the blood glucose level detected by the sensor and transmitting the blood glucose level to a remote device; a capacitive sensor and a compressible adhesive, wherein the capacitive sensor is disposed inside the analyte detection device and the compressible adhesive is disposed below the analyte detection device, and the capacitive sensor is used to detect the capacitance value between itself and the skin.

[0008] According to one aspect of the present invention, the analyte detection device is an integrated analyte detection device or a separate analyte detection device.

[0009] According to one aspect of the present invention, the compressible adhesive includes at least one of compressible foam adhesive and compressible silicone adhesive.

[0010] According to one aspect of the present invention, the thickness of the compressible adhesive is 0.1-2 mm.

[0011] According to one aspect of the present invention, the analyte detection device further includes adhesive tape.

[0012] According to one aspect of the present invention, adhesive tape covers a compressible adhesive and extends outward along the edge of the compressible adhesive.

[0013] According to one aspect of the present invention, adhesive tape and compressible adhesive are arranged side by side below the analyte detection device, with the edges of the adhesive tape and compressible adhesive extending outwards.

[0014] According to one aspect of the present invention, the capacitive sensor is positioned parallel to the skin below the analyte detection device.

[0015] According to one aspect of the present invention, a capacitive sensor is disposed on the PCB board of the analyte detection device.

[0016] According to one aspect of the present invention, when pressure is confirmed, the analyte detection device or remote device triggers a pressure alarm.

[0017] According to one aspect of the present invention, the analyte detection device or remote device is provided with preset conditions for triggering a pressure alarm.

[0018] According to one aspect of the present invention, the preset conditions are that the capacitance value detected by the capacitance sensor reaches a preset capacitance threshold, and the duration for which the capacitance value detected by the capacitance sensor reaches the preset capacitance threshold reaches a preset time threshold.

[0019] According to one aspect of this invention, the analyte detection device is further provided with an auxiliary sensor to help confirm compression.

[0020] According to one aspect of the present invention, the auxiliary sensor is a motion sensor and / or a temperature sensor.

[0021] According to one aspect of the present invention, a temperature sensor is disposed within the body of the sensor.

[0022] According to one aspect of this invention, the analyte detection device also helps to confirm compression based on the signal from the sensor.

[0023] Compared with the prior art, the technical solution of this utility model has the following advantages: This utility model discloses an analyte detection device with a compressible adhesive, comprising a capacitive sensor and a compressible adhesive. The capacitive sensor is disposed inside the analyte detection device, and the compressible adhesive is disposed below the analyte detection device. The capacitive sensor is used to detect the capacitance value between itself and the skin, thereby determining whether the analyte sensor is under pressure. When the analyte detection device is under pressure, the compressible adhesive is compressed. Compared with the prior art, the distance between the skin and the capacitive sensor changes significantly, resulting in a significant change in the capacitance detected by the capacitive sensor, which can detect the analyte detection device being under pressure in a timely and accurate manner.

[0024] Furthermore, compressible adhesives include, but are not limited to, compressible foam adhesives and compressible silicone adhesives, such as polyurethane foam adhesives, polymer foam adhesives, silicone foam adhesives, and polystyrene foam adhesives. These compressible adhesives are not only compressible but also have low density and light weight, helping to reduce the overall weight of the CGM; moreover, they possess high elasticity, returning to their original shape after the pressure on the CGM is released, allowing the capacitive sensor to continue to detect pressure promptly and accurately.

[0025] Furthermore, the analyte detection device also includes adhesive tape that extends outward along the edge of the compressible adhesive, allowing CGM to adhere better to the skin.

[0026] Furthermore, the adhesive tape and compressible adhesive are arranged side by side and extend outward along the edge of the compressible adhesive. The adhesive tape and compressible adhesive do not overlap in the thickness direction, which can further reduce the overall thickness of CGM after the compressible adhesive is applied.

[0027] Furthermore, when the capacitive sensor detects compression, the CGM or remote device will trigger an alarm to alert the user that the CGM is compressed and suggest that the user adjust their posture to obtain a more accurate blood glucose concentration level, thus improving the user experience.

[0028] Furthermore, the processor of the CGM or remote device is also pre-programmed with a program to trigger a pressure alarm. This prevents false pressure alarms by confirming that the capacitance value detected by the capacitance sensor exceeds a preset capacitance threshold and the duration exceeds a preset time, thereby improving the accuracy of pressure detection and enhancing the user experience.

[0029] Furthermore, the analyte detection device can also incorporate signals from at least one of the motion sensor, temperature sensor, and analyte sensor to help confirm compression and improve the accuracy of compression detection. The temperature sensor signal can also help calibrate the detection value of the analyte sensor, improving the detection accuracy of the analyte detection device. Attached Figure Description

[0030] Figures 1a-1d This is a schematic diagram of the structure of four analyte detection devices according to the first embodiment of the present invention; Figure 2a This is a schematic diagram of the integrated analyte detection device according to the second embodiment of the present invention before it is subjected to pressure. Figure 2b This is a schematic diagram of the integrated analyte detection device according to the second embodiment of the present invention under pressure. Figure 2c and Figure 2d for Figure 2a A schematic diagram of the A-A' cross-sectional structure; Figure 2e This is a schematic diagram of the analyte detection device including a double-helix electrode capacitive sensor according to the second embodiment of the present invention; Figure 2f This is a schematic diagram illustrating the detection principle of the double-helix electrode capacitive sensor according to the second embodiment of the present invention; Figure 2g This is a schematic diagram of the structure of the split-type analyte detection device according to the second embodiment of the present invention; Figure 3a This is a schematic diagram of the integrated analyte detection device according to the third embodiment of the present invention; Figure 3b This is a schematic diagram of the structure of a pouch battery integrated with a double-helix electrode capacitive sensor according to the third embodiment of the present invention; Figure 3c and Figure 3d This is a schematic diagram of the structure of the split-type analyte detection device according to the third embodiment of the present invention. Detailed Implementation

[0031] As mentioned earlier, existing CGM devices are worn on the upper arm or waist. When the user lies on their side or leans back, the CGM is compressed, causing the sensor to shift or become detached from the tissue fluid. This can lead to errors or missing blood glucose monitoring data, affecting the user's treatment and even posing a safety risk to the user.

[0032] Research has found that the cause of the above problems is that existing analyte detection devices do not have the function of detecting CGM compression, or the compression detection structure is not sensitive enough to detect CGM compression in a timely and accurate manner.

[0033] To address this issue, this invention provides an analyte detection device. A compressible adhesive is placed between the bottom shell and the skin, and a capacitive sensor is installed inside the shell. When the analyte detection device is compressed, the compressible adhesive is compressed. Compared to existing detection methods, the distance between the skin and the capacitive sensor changes significantly, and the corresponding capacitance changes more noticeably. This allows for timely and accurate detection of compression of the analyte detection device.

[0034] 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 present invention.

[0035] 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.

[0036] The following description of exemplary embodiments is merely illustrative and is not intended to limit the present 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.

[0037] It should be noted that similar reference numerals 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.

[0038] Example 1 Figure 1a and Figure 1b This is a schematic diagram of the structure of two analyte detection devices according to the first embodiment of this utility model.

[0039] like Figure 1a As shown, the analyte detection device 10 is an integrated CGM, meaning that before use by the user, the sensor assembly 103 and the transmitter assembly are already housed in the same housing 101. In this embodiment, the transmitter assembly is mounted on a PCB board 102, which also houses other necessary electronic components for the normal operation of the CGM, such as a processor and memory. The sensor assembly 103 is electrically connected to the PCB board 102, allowing for direct, integrated installation by the user without the need for separate installation of the base housing and transmitter.

[0040] like Figure 1b As shown, the analyte detection device 11 is a split CGM, meaning that before being used by the user, the sensor assembly 103 and the transmitter assembly 111 are separate. The sensor assembly 103 is mounted on the bottom shell 112, and the PCB board 102 is mounted in the transmitter assembly 111. During use, the bottom shell 112 with the sensor assembly 103 is installed first, and then the transmitter assembly 111 is installed. The two are then snapped together to form a complete CGM. The transmitter assembly 111 and the sensor assembly 103 are electrically connected through electrical contacts 107.

[0041] The analyte detection devices 10 and 11 also include adhesive tape 104 and compressible adhesive 105. In this embodiment, the compressible adhesive 105 is disposed below the adhesive tape 104. In other embodiments, the compressible adhesive 105 may be disposed above the adhesive tape 104. The analyte detection devices 10 and 11 are attached to the skin 100 via the adhesive tape 104 and the compressible adhesive 105. The analyte sensor 1031 is inserted subcutaneously to detect the blood glucose concentration in the tissue fluid and transmits the blood glucose concentration signal to the transmitter assembly. The transmitter assembly then transmits the signal to a remote device, such as a smartphone or handheld device, so that the user can view their dynamic blood glucose levels at any time.

[0042] The analyte detection devices 10 and 11 also include a capacitance sensor 106, which is electrically connected to the PCB board 102 and positioned directly opposite the skin below the CGM, i.e., parallel to the skin below the CGM. In the analyte detection device 10, the capacitance sensor 106 is located inside the housing 101, either inside the lower housing 1011 or directly on the PCB board 102. In the analyte detection device 11, the capacitance sensor 106 is located inside the emitter assembly 111, either inside the emitter assembly housing 1111 or directly on the PCB board 102. This allows the capacitance sensor 106 to detect changes in capacitance between itself and the skin 100 caused by variations in the thickness of the compressible adhesive 105, thereby confirming whether the CGM is being compressed.

[0043] The capacitive sensor 106 is used to detect the capacitance value between the skin 100 and the capacitive sensor 106. When the CGM is not compressed, such as during normal standing, sitting, lying down, or walking, the distance between the skin 100 and the capacitive sensor 106 remains unchanged, so the capacitance value detected by the capacitive sensor 106 does not change. When the CGM is compressed, such as when the user is lying on their side or leaning against something, the compressible adhesive 105 is compressed as a compressible medium. Compared with the solution in the prior art CN117045247A, the distance between the skin 100 and the capacitive sensor 106 changes significantly, so the capacitance value detected by the capacitive sensor 106 also increases significantly. The significant change in the capacitance value detected by the capacitive sensor 106 determines whether the CGM is compressed.

[0044] In response to the capacitive sensor 106 detecting compression, the CGM or a remote device triggers an alarm, such as the CGM emitting an audible sound and / or the remote device emitting an audible sound, displaying a compression notification, vibrating, or flashing a light to alert the user that the CGM is compressed, suggesting that the user adjust their posture to obtain a more accurate blood glucose concentration level, thereby improving the user experience.

[0045] Furthermore, the CGM or remote device can also indicate that the blood glucose data detected during the period of CGM compression may be inaccurate, and dynamically compensate and correct the blood glucose data during the compression phase by retrieving historical data or using prediction algorithms to ensure the accuracy of blood glucose monitoring.

[0046] In this embodiment of the invention, the compressible adhesive 105 includes, but is not limited to, compressible foam adhesive, compressible silicone, such as polyurethane foam adhesive, polymer foam adhesive, silicone foam adhesive, polystyrene foam adhesive, etc. The aforementioned compressible adhesives are not only compressible but also have low density and light weight, helping to reduce the overall weight of the CGM; moreover, they have high elasticity, returning to their original shape after the pressure on the CGM is released, allowing the capacitive sensor to continue to detect pressure promptly and accurately. The thickness of the compressible adhesive 105 is 0.1-2 mm, preferably 0.5-1 mm. Excessive thickness of the compressible adhesive 105 will result in an excessively thick CGM, affecting the user experience; if the thickness is too thin, the compression distance of the compressible adhesive will be too small when the CGM is compressed, further resulting in an insignificant change in detected capacitance, thus affecting the accuracy of pressure detection. The area of ​​the compressible adhesive 105 is almost equivalent to the area of ​​the lower housing 1011 or the bottom housing 112, with only a small hole, consistent with the lower housing 1011 or the bottom housing 112, reserved for the analyte sensor 1031 to pass through.

[0047] In this embodiment of the utility model, the area of ​​the adhesive tape 104 is not less than the area of ​​the compressible adhesive 105. Preferably, the area of ​​the adhesive tape 104 is larger than the area of ​​the compressible adhesive 105. The adhesive tape 104 completely covers the compressible adhesive 105 and extends outward 2-5mm along the edge of the compressible adhesive 105 so that the CGM can be better adhered to the skin 100.

[0048] In another embodiment of this utility model, the adhesive tape 104 may not be included. The compressible adhesive 105 can simultaneously serve as both the adhesive tape 104 and the compressible medium, thereby reducing the overall thickness of the CGM or increasing the set thickness of the compressible adhesive 105.

[0049] In another embodiment of this utility model, the adhesive tape 104 does not cover the compressible adhesive 105, but only extends outward from the edge of the compressible adhesive 105 to 2-5mm beyond the edge of the lower housing 1011 or the bottom housing 112, such as... Figure 1c As shown, the edges of the adhesive tape 104 and the compressible adhesive 105 are arranged side by side and adjacent to each other below the lower housing 1011 or the bottom housing 112. In this utility model, since the adhesive tape 104 and the compressible adhesive 105 are arranged side by side, they do not overlap in the thickness direction of the CGM, which can further reduce the overall thickness of the CGM after the compressible adhesive 105 is set.

[0050] In another embodiment of this utility model, the adhesive tape 104 does not completely cover the compressible adhesive 105. Instead, the adhesive tape 104 and the compressible adhesive 105 overlap by 1-2 mm below the lower housing 1011 or the bottom housing 112, and continue to extend 2-5 mm beyond the edge of the lower housing 1011 or the bottom housing 112. Figure 1d As shown, although the tape 104 is placed between the bottom shell of the CGM and the compressible adhesive 105, the tape 104 is very thin, the compressible adhesive 105 is sticky, and the CGM will be subjected to pressure during installation. Therefore, it can also be considered that the compressible adhesive 105 is in direct contact with the CGM.

[0051] When users engage in certain activities or accidentally touch the CGM, it may cause the CGM to be detected as compressed. Since the compression during exercise may be short-lived and repetitive, if the CGM or remote device triggers a compression alarm at this time, the alarm will also be triggered repeatedly. This is an unnecessary alarm for the user and it is necessary to eliminate it to improve the user experience.

[0052] In this embodiment of the invention, the processor of the CGM or remote device is further preset with conditions for triggering the pressure alarm, including the following steps: Step 1: Confirm the capacitance value C1 detected by the capacitance sensor 106. The processor has a preset capacitance threshold Cv for triggering the pressure alarm. The preset capacitance threshold Cv can be set according to the capacitance value C0 detected by the capacitance sensor 106 when the CGM is not under pressure. For example, the preset capacitance threshold Cv can be set to 1.2 or 1.5 times C0. That is, the pressure alarm may be triggered only when the detected capacitance value C1 is at least 20% or 50% greater than C0.

[0053] Step 2: Confirm the duration t for which the capacitance value C1 detected by the capacitance sensor 106 is greater than the preset capacitance threshold Cv. The duration t must be greater than the time threshold tv, such as 30s or 1min.

[0054] Only when both of the above conditions are met will the CGM or remote device trigger the compression alarm, in order to reduce false alarms and improve user experience.

[0055] In other embodiments of this utility model, in order to further accurately determine the pressure caused by lying on one's side or leaning back, pressure can also be detected based on signals from one or more other auxiliary sensors, such as setting a motion sensor in the CGM. If the motion sensor signal shows that the user is in a non-moving state, it can help confirm the pressure. For example, a temperature sensor can be installed in a CGM. When the user lies on their side or leans back, the temperature of the compressed tissue will rise. The temperature sensor is located within the body portion of the analyte sensor 1031. A detailed description of the specific arrangement can be found in the specification of PCT international application PCT / CN2024 / 119942, the contents of which are incorporated herein by reference. When the temperature sensor signal indicates an increase in the user's body temperature, it can help confirm compression. Furthermore, based on the detected body temperature, it can also help calibrate the detected blood glucose value, improving the accuracy of blood glucose testing.

[0056] In other embodiments of this invention, CGM can also help confirm compression at least through the signal of the analyte sensor 1031 itself. When the user is lying on their side or leaning against something, the blood and tissue fluid circulation in the user's arm becomes poor, which will cause the blood glucose value measured by the analyte sensor 1031 to be lower than the actual estimated blood glucose value or the blood glucose value to drop rapidly in a short period of time. When the user confirms that the blood glucose value detected by the analyte sensor 1031 is lower than the actual estimated blood glucose value or the blood glucose value drops rapidly in a short period of time, it can also help confirm compression.

[0057] Example 2 Figure 2a This is a schematic diagram of the integrated analytical substance detection device according to the second embodiment of the present invention before being subjected to pressure; Figure 2b This is a schematic diagram of the integrated analyte detection device according to the second embodiment of the present invention under pressure. Figure 2c and Figure 2d for Figure 2a A schematic diagram of the A-A' cross-sectional structure; Figure 2e This is a schematic diagram of the analyte detection device including a double-helix electrode capacitive sensor according to the second embodiment of the present invention; Figure 2f This is a schematic diagram illustrating the detection principle of the double-helix electrode capacitive sensor according to the second embodiment of the present invention; Figure 2g This is a schematic diagram of the structure of the split-type analytical analyte detection device according to the second embodiment of the present invention.

[0058] like Figure 2a As shown, the analyte detection device 20 is for use with... Figure 1a Similar to the analyte detection device 10, this integrated analyte detection device includes a housing 201. Inside the housing 201 are a sensor assembly 203 and a transmitter assembly. The transmitter assembly is mounted on a PCB board 202. The sensor assembly 203 is electrically connected to the PCB board 202. The sensor 203 is inserted subcutaneously to detect the blood glucose concentration in the tissue fluid and transmits the blood glucose concentration signal to the transmitter assembly, which then transmits it to a remote device, such as a smartphone or handheld device, so that the user can view their dynamic blood glucose levels at any time. The difference lies in that the capacitive sensor 206 is located on the inner side of the housing 201. Preferably, the capacitive sensor 206 is located on the inner side of the upper housing 2012. The capacitive sensor 206 is electrically connected to the PCB board 102. Specifically, a capacitance detection chip is mounted on the PCB board, and the capacitive sensor 206 is connected to the capacitance detection chip via a wire. The capacitive sensor 206 is used to detect the capacitance value between the skin 200 and the capacitive sensor 206. In this embodiment of the invention, the capacitive sensor 206 is a thin sheet structure, which is adhered to the inner side of the housing 201. This allows for a better fit to the housing 201 while minimizing the amount of internal space occupied by the CGM, thus reducing the overall volume increase. In other embodiments of the invention, other methods can be used to fix the thin sheet capacitive sensor 206 to the inner side of the housing 201.

[0059] Reference Figure 2a and Figure 2bWhen the analyte detection device 20 is attached to the skin with adhesive tape (not shown) and is not under pressure, the side of the housing 201 does not contact the skin, meaning there is no skin directly facing the capacitance sensor 206. Therefore, the capacitance value detected by the capacitance sensor 206 is almost zero. However, when the analyte detection device 20 is under pressure, the skin surface indents, and the side of the housing 201 is covered by the skin. This significantly increases the area of ​​skin directly facing the capacitance sensor 206, and the capacitance value detected by the capacitance sensor 206 also increases significantly. The significant change in the capacitance value detected by the capacitance sensor 206 determines whether the CGM is under pressure. Furthermore, the greater the pressure, the larger the area of ​​skin 200 covering the side of the housing 201, and the larger the capacitance value detected by the capacitance sensor 206.

[0060] In response to the capacitive sensor 206 detecting compression, the CGM or a remote device triggers an alarm, such as the CGM emitting an audible sound and / or the remote device emitting an audible sound, displaying a compression notification, vibrating, or flashing a light to alert the user that the CGM is compressed, suggesting that the user adjust their posture to obtain a more accurate blood glucose concentration level, thus improving the user experience.

[0061] Furthermore, the CGM or remote device can also indicate that the blood glucose data detected during the period of CGM compression may be inaccurate, and dynamically compensate and correct the blood glucose data during the compression phase by retrieving historical data or using prediction algorithms to ensure the accuracy of blood glucose monitoring.

[0062] In this embodiment of the invention, the thin-film capacitive sensor 206 includes, but is not limited to, metal thin films, such as gold, aluminum, and copper, which have high conductivity and can improve the signal response speed of the capacitive sensor 206, and are low in cost, reducing the economic burden on users; metal oxide thin films, such as ruthenium dioxide, manganese dioxide, tantalum pentoxide, zinc oxide, nickel oxide, and titanium oxide, which have high dielectric constants and can significantly increase the capacitance per unit area, thereby improving the signal response speed of the capacitive sensor 206; and a rigid-flex PCB (FPC), which combines the stability of a rigid PCB with the flexibility of a flexible circuit, can better fit the housing 201, avoid occupying the internal space of the CGM, and facilitate the miniaturization of the CGM. At the same time, the metal thin film layer on the FPC can also improve the signal response speed of the capacitive sensor 206.

[0063] In one embodiment of this utility model, the capacitive sensor 206 is a separate square sheet structure that surrounds or partially surrounds the inner side of the housing 201, such as... Figure 2cAs shown, preferably, the capacitive sensor 206 is a thin sheet structure that surrounds the inner side of the housing 201. In this case, the area of ​​the capacitive sensor 206 can be set to the maximum. When the CGM is compressed, the skin being compressed can be directly opposite the capacitive sensor 206, and the detected capacitance is also the maximum, which can improve the accuracy of compression detection.

[0064] In another embodiment of this utility model, the capacitive sensor 206 is a combination of n sub-capacitive sensors, where n≥2, such as... Figure 2d As shown, the n sub-capacitive sensors are also square thin-film structures. The area and arrangement of each sub-capacitive sensor can be set according to the structural features of the CGM housing. For example, when the top view of the CGM is square, one sub-capacitive sensor can be set on each of the four sides of the CGM housing. The size of the sub-capacitive sensor on each side is adapted to the size of that side. Alternatively, multiple sub-capacitive sensors can be evenly set on each side, with each sub-capacitive sensor having the same area. When the top view of the CGM is circular, each sub-capacitive sensor has the same size and is evenly and symmetrically distributed on the inner circumference of the CGM.

[0065] Each sub-capacitance sensor 206n is operably electrically connected to PCB 202. When the CGM is compressed, each sub-capacitance sensor 206n can detect the capacitance value between itself and the corresponding skin. Figure 2c The capacitive sensor in the CGM has an overall thin-film structure. The area of ​​each sub-capacitive sensor is relatively small. Therefore, the capacitance value detected by the sub-capacitive sensor 206n is also small. However, since multiple sub-capacitive sensors are set on the inner side of the CGM, each sub-capacitive sensor can detect changes in capacitance value. Based on the changes in capacitance value detected by different sub-capacitive sensors, the specific location of the CGM being compressed can be accurately determined. This allows for more accurate compression alarms to be provided to the user, along with targeted prompts to relieve the compression. For example, the CGM or a remote device can inform the user via voice and / or graphics that the left side of the CGM may be compressed and to turn the body or arm to the right.

[0066] In another embodiment of this utility model, the capacitive sensor 206 consists of two identical, intertwined double-helix electrodes, such as... Figure 2e and Figure 2fAs shown in Figures 206-1 and 206-2, these electrodes are disposed on the inner surface of the housing 201. When the CGM is compressed, the skin 200 gradually covers the double-helix electrodes upwards. However, the areas covering the double-helix electrodes 206-1 and 206-2 are different. When the skin 200 first covers the double-helix electrodes, the area covered by electrode 206-1 is much larger than that covered by electrode 206-2. Therefore, the capacitance values ​​detected by the two electrodes with respect to the skin 200 are different. Furthermore, as the compression deepens, i.e., the skin 200 continues to move upwards, the area covered by electrode 206-1 decreases, while the area covered by electrode 206-2 increases. When a side of the CGM is compressed, not only are the areas covered by the skin different for the two electrodes, but the distances between the two electrodes and the skin also differ on different sides of the CGM. Therefore, by measuring the coupling changes in capacitance between these two electrodes and the skin 200, and using an algorithm for calculation, the location of compression can be accurately determined without the need for... Figure 2d Similarly, multiple sub-capacitive sensors are set up.

[0067] like Figure 2g As shown, the analyte detection device 21 is for use with... Figure 1b Similar to the analyte detection device 11, this split-type analyte detection device involves first installing the base shell 212 with the sensor assembly 203, then installing the transmitter assembly 211. The two are then snapped together to form a complete CGM. The transmitter assembly 211 and the sensor assembly 203 are electrically connected via electrical contacts 207. A capacitance sensor 206 is located on the inner side of the transmitter assembly 211 housing 2111 and is used to detect the capacitance value between the capacitance sensor 206 and the skin wrapped around the CGM when compressed. The structure and arrangement of the capacitance sensor 206 are consistent with those in the integrated analyte detection device 20 and will not be repeated here.

[0068] To eliminate pressure alarms triggered by accidental touches, the processor of the CGM or remote device in this embodiment of the invention also has preset conditions for triggering pressure alarms. Since the capacitance value detected by the capacitance sensor 206 is almost zero when no pressure occurs in this embodiment of the invention, for the capacitance sensor 206, including each sub-capacitance sensor 206n, there is no need to set a capacitance threshold or set a capacitance threshold Cv based on experience. Instead, a time threshold tv is set for the duration t after the capacitance value is detected or exceeds the capacitance threshold Cv. If the capacitance sensor 206 or any sub-capacitance sensor 206n detects a capacitance value and the duration t is greater than the time threshold tv, such as 30 seconds or 1 minute, the CGM or remote device will trigger a pressure alarm to reduce false alarms and improve user experience.

[0069] In other embodiments of this utility model, in order to further accurately determine the pressure caused by lying on one's side or leaning, one or more other signals can be used to help detect the pressure, such as the motion sensor, temperature sensor, and signals from the analysis sensor described in Embodiment 1 to help confirm the pressure, etc., which will not be repeated here.

[0070] In this embodiment of the invention, the analyte detection device 20 or 21 may also be equipped with the compressible adhesive 105 as in Embodiment 1, and a capacitance sensor 106 as a second capacitance sensor. By simultaneously detecting the capacitance value between the capacitance sensor 106 and the skin 100 directly below the CGM, and the capacitance value between the capacitance sensor 206 and the skin 200 directly to the side of the CGM, the pressure detection is performed in a complementary manner, thereby further improving the accuracy of the pressure detection.

[0071] Example 3 Figure 3a This is a schematic diagram of the integrated analyte detection device according to the third embodiment of the present invention; Figure 3b This is a schematic diagram of the structure of a pouch battery integrated with a double-helix electrode capacitive sensor according to the third embodiment of the present invention; Figure 3c and Figure 3d This is a schematic diagram of the structure of the split-type analytical analyte detection device according to the third embodiment of the present invention.

[0072] like Figure 3a As shown, the analyte detection device 30 is for use with... Figure 1a and Figure 2a Similar integrated analyte detection devices 10 and 20 include a housing 301, within which a sensor assembly 303 and a transmitter assembly are housed. The transmitter assembly is mounted on a PCB board 302. The sensor assembly 303 is electrically connected to the PCB board 302. The sensor 303 is inserted subcutaneously to detect blood glucose concentration in tissue fluid and transmits the blood glucose concentration signal to the transmitter assembly, which then transmits it to a remote device, such as a smartphone or handheld device, allowing the user to view their dynamic blood glucose levels at any time. The difference lies in the fact that in analyte detection devices 10 and 20, the battery providing power to the analyte detection device is a button cell battery, and... Figure 1a and Figure 2aNot shown in the diagram, but in the analyte detection device 30, the battery 308 is a pouch battery. Since the outer shell of the pouch battery 308 is an aluminum-plastic film, which contains a thin aluminum layer, a capacitance sensor 206 as shown in Embodiment 2 can be formed through appropriate processing. The processing methods include, but are not limited to, connecting one end of a wire to the thin aluminum layer in a very small area of ​​the aluminum-plastic film by micro-spot welding or conductive silver paste, and connecting the other end of the wire to the PCB board 302. A capacitance detection chip is provided on the PCB board. Specifically, connecting the other end of the wire to the capacitance detection chip can ensure that the pouch battery encapsulation is not damaged, and the thin aluminum layer of the pouch battery can be used as a capacitance sensor to detect the capacitance value between the capacitance sensor and the skin 300.

[0073] In this embodiment of the invention, on the one hand, since the capacitive sensor itself is the outer shell of the pouch battery 308, no separate component occupies the internal space of the analyte detection device, resulting in an increase in the overall volume of the analyte detection device; on the other hand, since the pouch battery 308 has a pouch-like structure, that is, a flat cuboid structure, the entire outer shell acts as a capacitive sensor. When the analyte detection device is not compressed, the capacitive sensor detects the capacitance value between itself and the skin directly below the analyte detection device 30. When the analyte detection device is compressed, the side of the shell 301 is wrapped by the skin 300, and the skin outside the side of the shell 301 faces the side shell of the pouch battery 308, that is, the area of ​​skin facing the capacitive sensor increases, including the skin facing the bottom and side of the pouch battery 308. Therefore, the capacitance value detected by the capacitive sensor also increases significantly. Based on the significant change in the capacitance value detected by the capacitive sensor, it is possible to determine in a timely and accurate manner whether the CGM is compressed.

[0074] In response to the capacitive sensor 206 detecting compression, the CGM or a remote device triggers an alarm, such as the CGM emitting an audible sound and / or the remote device emitting an audible sound, displaying a compression notification, vibrating, or flashing a light to alert the user that the CGM is compressed, suggesting that the user adjust their posture to obtain a more accurate blood glucose concentration level, thus improving the user experience.

[0075] Furthermore, the CGM or remote device can also indicate that the blood glucose data detected during the period of CGM compression may be inaccurate, and dynamically compensate and correct the blood glucose data during the compression phase by retrieving historical data or using prediction algorithms to ensure the accuracy of blood glucose monitoring.

[0076] When the analyte detection device is not compressed, the bottom surface of the pouch battery 308 faces the skin, and the capacitance sensor can detect the capacitance value C0. When the analyte detection device is compressed, the bottom surface of the pouch battery 308 faces the skin, the distance from the skin, and the medium do not change, so the corresponding capacitance value does not change. However, the sides of the pouch battery 308 also face the skin, which increases the detected capacitance value. Therefore, in this embodiment of the invention, to eliminate unnecessary pressure alarms, the pre-set conditions for triggering a pressure alarm in the processor of the CGM or remote device include the following steps: Step 1: Confirm that the capacitance value C1 detected by the capacitance sensor exceeds the preset capacitance threshold Cv, i.e., confirm that C1>Cv. The preset capacitance threshold Cv can be set based on the capacitance value C0 detected by the capacitance sensor when the CGM is not under pressure. For example, the preset capacitance threshold Cv can be set to 1.2 or 1.5 times C0. Step 2: Confirm the duration t for which the capacitance value C1 detected by the capacitance sensor is greater than the preset capacitance threshold Cv. The duration t must be greater than the time threshold tv, such as 30s or 1min. That is, confirm that the duration t for C1>Cv is greater than tv.

[0077] Only when both of the above conditions are met will the CGM or remote device trigger the compression alarm, in order to reduce false alarms and improve user experience.

[0078] In another embodiment of this invention, the outer casing of the pouch battery 308 can be divided into multiple independent areas without compromising the encapsulation integrity of the pouch battery 308 casing. For example, micron-level insulating trenches can be carved on the outer casing of the pouch battery using laser ablation or precision mechanical engraving, dividing the casing into three unconnected areas: the bottom surface, the top surface, and the side surface. Simultaneously, only in the side area, one end of a wire is connected to the thin-film aluminum layer in a very small area of ​​the aluminum-plastic film on the side using micro-spot welding or conductive silver paste, and the other end of the wire is connected to the PCB 30. In this case, only the side thin-film aluminum layer acts as a capacitance sensor, similar to the capacitance sensor 206 in Embodiment 2. When the analyte detection device is not compressed, the capacitance value detected by the capacitance sensor is almost 0. When the analyte detection device is compressed, the capacitance value detected by the capacitance sensor increases significantly. The significant change in the capacitance value detected by the capacitance sensor determines whether the CGM is compressed.

[0079] In another embodiment of the present invention, the side shell of the soft-pack battery 308 can be divided into two or more unconnected areas, and only one of them can be selected as a capacitance sensor. In this case, the capacitance sensor is partially surrounded by the side of the soft-pack battery.

[0080] In another embodiment of this utility model, referring to Embodiment 2, the side shell of the soft-pack battery 308 can be divided into n unconnected regions. A similar approach can be used to treat each region as multiple sub-capacitor sensors, similar to 206n, while ensuring the integrity of the soft-pack battery 308's casing. The specific configuration can be found in the sub-capacitor sensor 206n in Embodiment 2, and will not be repeated here.

[0081] In another embodiment of this utility model, the side shell of the soft-pack battery 308 can also be divided into two identical double-helix electrodes 306-1 and 306-2, intertwined, as shown in Embodiment 2. Figure 3b As shown, by measuring the capacitance changes between the two electrodes and the skin, and using an algorithm to calculate, the location of the compression can be accurately determined.

[0082] To eliminate unnecessary pressure alarms, the processor of the CGM or remote device in this embodiment of the invention presets the conditions for triggering pressure alarms. The specific conditions are the same as in Embodiment 2, that is, there is no need to set a capacitance threshold or set a capacitance threshold Cv based on experience. Instead, a time threshold tv is set for the duration t after the capacitance value is detected or the detected capacitance value exceeds the capacitance threshold Cv. If the capacitance sensor or any sub-capacitor sensor detects a capacitance value or the detected capacitance value is greater than the capacitance threshold Cv, and the duration t is greater than the time threshold tv, such as 30s or 1min, the CGM or remote device will trigger a pressure alarm to reduce false alarms and improve user experience.

[0083] like Figure 3c and Figure 3d As shown, the analyte detection devices 31 and 32 are for use with... Figure 1b and Figure 2g Similar to the analyte detection devices 11 and 21, these are split-type analyte detection devices. In use, the base housing 312 with the sensor assembly 303 is installed first, followed by the transmitter assembly 311. The two are then snapped together to form a complete CGM. The transmitter assembly 311 and the sensor assembly 303 are electrically connected via electrical contacts 307. The difference lies in the battery: in analyte detection devices 11 and 21, the battery is a button cell battery (not shown), while in analyte detection devices 31 and 32, the battery is a pouch cell battery 308, the same type used in analyte detection device 30. In analyte detection device 31, the pouch cell battery 308 is housed in the transmitter 311; in analyte detection device 32, the pouch cell battery 308 is housed in the base housing 312.

[0084] In both analyte detection devices, the pouch battery 308 is used in the same manner as the pouch battery in analyte detection device 30. The thin aluminum layer in the outer casing of the pouch battery 308 is used as a capacitive sensor to detect the capacitance value between the capacitive sensor and the skin 300. This method does not increase the overall volume of the analyte detection devices 31 and 32, while still enabling timely and accurate pressure detection. The entire pouch battery can be used as a capacitive sensor, or only a portion of the pouch battery, such as the side of the pouch battery casing, can be used. Alternatively, the pouch battery casing can be divided into multiple areas to serve as multiple sub-capacitive sensors, or the pouch battery casing can be divided into two double-helix electrodes to form a capacitive sensor. Specific operating methods are as described in analyte detection device 30 and will not be repeated here. The preset alarm conditions for eliminating unnecessary pressure alarms are also consistent with those described in analyte detection device 30 and will not be repeated here either.

[0085] In the analyte detection devices 30, 31, and 32, when at least the bottom surface of the pouch battery 308 serves as a capacitive sensor, the compressible adhesive 105 from Embodiment 1 can also be used. The capacitance value between the capacitive sensor and the skin 300 directly below the CGM is detected to determine whether the analyte detection device is under pressure. Compared to existing solutions, the compressible adhesive exhibits a larger distance change when compressed, resulting in a more significant change in the capacitance value detected by the capacitive sensor. This allows for better detection and confirmation of whether the analyte detection device is under pressure, improving the accuracy of pressure detection. It should be noted that at least the bottom surface of the pouch battery 308 serves as a capacitive sensor, including the entire pouch battery 308 casing. The pouch battery 308 casing is divided into a top surface, a bottom surface, and a side surface, with both the bottom and side surfaces simultaneously serving as capacitive sensors. Additionally, the pouch battery 308 casing may be divided into at least a bottom surface, with the bottom surface serving as a separate capacitive sensor.

[0086] In other embodiments of this invention, the outer casing of the pouch battery 308 itself does not serve as a capacitance sensor. Instead, one or more individual capacitance sensors are integrated outside the outer casing of the pouch battery 308. For example, a thin-film capacitance sensor, as described in Embodiment 2, is fixedly mounted by means of adhesive or other methods, at least partially surrounding the side of the pouch battery. Multiple sub-capacitor sensors or double-helix electrode capacitance sensors are disposed on the side of the pouch battery, and a capacitance sensor is disposed on the bottom surface of the pouch battery. The types of capacitance sensors, their placement methods, and the methods for eliminating false pressure alarms are all as described in Embodiment 2 and will not be repeated here. When a capacitance sensor is disposed on the bottom surface of the pouch battery 308, the compressible adhesive 105 described in Embodiment 1 can also be used. The analyte detection device is determined to be under pressure by detecting the capacitance value between the capacitance sensor and the skin 300 directly below the CGM.

[0087] In other embodiments of this utility model, in order to further accurately determine the pressure caused by lying on one's side or leaning against something, other auxiliary sensor signals can also be used to help detect the pressure, such as the motion sensor and temperature sensor described in Embodiment 1, and the signals from the sensors can be used to help confirm the pressure, etc., which will not be described in detail here.

[0088] In summary, this utility model discloses an analyte detection device. A compressible adhesive is disposed between the bottom shell and the skin, and a capacitive sensor is disposed inside the shell. When the analyte detection device is compressed, the compressible adhesive is compressed. Compared with the prior art, the distance between the skin and the capacitive sensor changes significantly, and the corresponding capacitance also changes significantly. This allows for timely and accurate detection of compression of the analyte detection device.

[0089] While specific embodiments of the present 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 present 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 present invention. The scope of the present invention is defined by the appended claims.

Claims

1. An analyte detection device with a compressible adhesive, characterized in that, include: A sensor assembly, comprising a sensor inserted under the skin for detecting a user's blood glucose level; A transmitter assembly, operatively electrically connected to the sensor assembly, for receiving blood glucose values ​​detected by the sensor and transmitting the blood glucose values ​​to a remote device; A capacitive sensor and a compressible adhesive are provided. The capacitive sensor is disposed inside the analyte detection device, and the compressible adhesive is disposed below the analyte detection device. The capacitive sensor is used to detect the capacitance value between the adhesive and the skin.

2. The analyte detection device according to claim 1, characterized in that, The analyte detection device can be an integrated analyte detection device or a separate analyte detection device.

3. The analyte detection device according to claim 2, characterized in that, The compressible adhesive includes at least one of compressible foam adhesive and compressible silicone adhesive.

4. The analyte detection device according to claim 3, characterized in that, The thickness of the compressible adhesive is 0.1-2 mm.

5. The analyte detection device according to claim 1, characterized in that, The analyte detection device also includes adhesive tape.

6. The analyte detection device according to claim 5, characterized in that, The adhesive tape covers the compressible adhesive and extends outward along the edge of the compressible adhesive.

7. The analyte detection device according to claim 5, characterized in that, The adhesive tape and the compressible adhesive are arranged side by side below the analyte detection device, with the adhesive tape extending outward along the edge of the compressible adhesive.

8. The analyte detection device according to claim 1, characterized in that, The capacitive sensor is positioned parallel to the skin below the analyte detection device.

9. The analyte detection device according to claim 8, characterized in that, The capacitive sensor is mounted on the PCB board of the analyte detection device.

10. The analyte detection device according to claim 1, characterized in that, When pressure is confirmed, the analyte detection device or the remote device triggers a pressure alarm.

11. The analyte detection device according to claim 1, characterized in that, The analyte detection device or the remote device is equipped with preset conditions to trigger a pressure alarm.

12. The analyte detection device according to claim 11, characterized in that, The preset conditions are that the capacitance value detected by the capacitance sensor reaches a preset capacitance threshold, and the duration for which the capacitance value detected by the capacitance sensor reaches the preset capacitance threshold reaches a preset time threshold.

13. The analyte detection device according to claim 1, characterized in that, The analyte detection device is also equipped with an auxiliary sensor to help confirm compression.

14. The analyte detection device according to claim 13, characterized in that, The auxiliary sensor is a motion sensor and / or a temperature sensor.

15. The analyte detection device according to claim 14, characterized in that, The temperature sensor is disposed within the body of the sensor.

16. The analyte detection device according to claim 1, characterized in that, The analyte detection device also helps confirm compression based on signals from the sensor.

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