Miniature integrated blood glucose monitoring device and monitoring method thereof

Abstract

The application belongs to the technical field of medical devices, and discloses a micro integrated blood glucose monitoring device and a monitoring method thereof, in particular to a micro integrated blood glucose monitoring device, which comprises a bearing assembly, a contact-resistant assembly in contact with the skin is connected to one end of the bearing assembly, a closing assembly is movably arranged on the end of the bearing assembly away from the contact-resistant assembly, the bearing assembly comprises a connecting plate, a connecting cavity is formed in the connecting plate, a control panel is connected to the end of the connecting cavity away from the closing assembly, the rotating plate and the supporting plate can be rotated through the arranged identification assembly, the angle of the contact plate is self-adaptively adjusted according to the skin curve to ensure close fitting, the buffer plate is connected to the movable groove wall, the deformation of the buffer plate is captured by the identification sensor, the control panel is used to judge whether the device is inclined, the components are cooperated to reduce the displacement caused by human activities, the local pressure is dispersed, the skin compression feeling is reduced, and the wearing stability and comfort are improved.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, specifically a miniature integrated blood glucose monitoring device and its monitoring method. Background Technology

[0002] Blood glucose monitoring is of great significance for diabetic patients. Accurate and stable monitoring can help patients keep abreast of changes in their condition, take appropriate treatment measures, and reduce the occurrence of chronic complications.

[0003] Patent application CN201710395724.4 discloses a disposable monitoring device for a dynamic continuous blood glucose monitoring system, including a sensor assembly, a signal transmitter, and a sterile positioning patch. The sterile positioning patch is applied to the skin in the treatment area. The sensor assembly detects the amount of glucose passing through the skin within the sterile positioning patch area, and the signal transmitter wirelessly transmits the signal sensed by the sensor assembly to a monitor. All components of this invention are disposable, convenient and hygienic, with a small product size and easy portability. It eliminates the need for cleaning after use, simplifying operation and avoiding cross-infection during testing. Monitoring data is transmitted wirelessly to the monitor in real time, enabling uninterrupted dynamic monitoring of blood glucose data for diabetic patients. This allows monitoring personnel to remotely track the blood glucose concentration levels of diabetic patients, making it very convenient for both daily monitoring by users and monitoring by personnel. While the above solution achieves continuous blood glucose monitoring, the blood glucose monitoring device often shifts due to body movement during wear, resulting in a loose fit with the skin. This not only affects the accuracy of the monitoring data but may also cause discomfort to the patient due to excessive local pressure.

[0004] Meanwhile, some devices cannot dynamically adjust the monitoring frequency according to the patient's activity level. This results in either excessive energy consumption due to high-frequency monitoring or missing key blood glucose changes due to low-frequency monitoring. Furthermore, they cannot provide timely feedback and adjustments when the device is tilted or the sensor depth is inappropriate, causing numerous inconveniences for patients' daily use.

[0005] Therefore, in order to solve the above-mentioned technical problems, the present invention proposes a miniature integrated blood glucose monitoring device and its monitoring method. Summary of the Invention

[0006] The purpose of this invention is to address the above-mentioned problems. This invention provides a miniature integrated blood glucose monitoring device and its monitoring method, which has the advantage of adjusting the state of the blood glucose monitoring device according to the user's usage status.

[0007] To achieve the above objectives, the present invention provides the following technical solution: a miniature integrated blood glucose monitoring device, comprising a support component, a contact component that contacts the skin connected to one end of the support component, a sealing component movably provided on the end of the support component away from the contact component, the support component comprising a connecting plate, a connecting cavity formed in the connecting plate, and a control plate connected to the end of the connecting cavity away from the sealing component;

[0008] The abutting component includes an abutting part, on which a through hole is provided, and an elastic membrane is connected inside the through hole.

[0009] Preferably, an energy component is connected to one end of the sealing component near the contact component, and a signal transmission unit is connected to the sealing component. The perimeter of the energy component is smaller than the perimeter of the connecting cavity.

[0010] Preferably, a sensor is connected to one end of the energy component near the abutment component, and the sensor is able to pass through the elastic membrane.

[0011] Preferably, the supporting component is provided with a fixing part.

[0012] Preferably, the connecting plate has multiple movable slots on its circumference, and each movable slot is connected to an identification component.

[0013] Preferably, the identification component includes a buffer plate connected to the wall of the movable groove, a support plate connected to the buffer plate, a rotating plate rotatably connected to the end of the support plate away from the buffer plate, and an abutment plate connected to the end of the rotating plate away from the support plate.

[0014] Preferably, the end of the contact plate away from the rotating plate is provided with a patch for contact and fixation with the human body.

[0015] Preferably, the bearing assembly is equipped with an identification sensor that can identify the working status of the buffer plate.

[0016] A monitoring method using a miniature integrated blood glucose monitoring device includes the following steps:

[0017] S1. The contact part is attached to the target skin, and double fixation is achieved through the fixing part or the fixing adhesive of the identification component. The sealing component is fastened to the carrier component, the power component provides power, the sensor penetrates the skin through the elastic membrane, and the control board self-checks the component status.

[0018] S2. The control board integrates sensor acceleration and buffer plate deformation data to determine the intensity of the activity.

[0019] S3. The raw data from the sensor is filtered by the control board to generate blood glucose values; the signal transmission unit transmits data to the terminal via Bluetooth and stores historical data.

[0020] S4. When blood sugar exceeds the preset range, the signal transmission department will issue a warning; when the battery level is ≤10%, it will switch to "warning only" mode.

[0021] S5. Press the closed component to unlock and separate the parts, pull out the sensor, and peel off the adhesive on the fixing part or the identification component to complete the disassembly.

[0022] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0023] 1. The recognition components allow the rotating plate and support plate to rotate and adaptively adjust the angle of the contact plate according to the skin's curvature to ensure a tight fit. The buffer plate is connected to the movable groove wall, and its deformation is captured by the recognition sensor. Together with the control board, it determines whether the device is tilted. The components work together to reduce displacement caused by human movement, while dispersing local pressure, reducing skin pressure, and improving wearing stability and comfort.

[0024] 2. The buffer plate of the identification component has a built-in strain gauge, which converts deformation into an electrical signal and transmits it to the control board. Combined with the acceleration data of the identification sensor, it accurately judges the intensity of the user's activity. The control board adjusts accordingly, and the miniature displacement sensor of the sensor provides real-time feedback on depth. The control board dynamically adjusts to maintain contact with the tissue fluid. The cooperation of multiple components greatly improves the accuracy of data in different scenarios. Attached Figure Description

[0025] Figure 1 This is a schematic diagram of the overall structure of Embodiment 1 of the present invention;

[0026] Figure 2 This is a cross-sectional structural diagram of the overall structure of Embodiment 1 of the present invention;

[0027] Figure 3 This is a schematic diagram of the connection structure of the contact component of the present invention;

[0028] Figure 4 This is a schematic diagram of the connection structure of the sensor of the present invention;

[0029] Figure 5 This is a schematic diagram of the overall structure of Embodiment 2 of the present invention;

[0030] Figure 6 This is a schematic diagram of the connection structure of the identification component of the present invention;

[0031] Figure 7 This is a cross-sectional structural diagram of the identification component of the present invention.

[0032] Figure descriptions: 1. Bearing component; 101. Connecting plate; 1011. Movable groove; 102. Connecting cavity; 103. Control plate; 2. Enclosure component; 3. Contact component; 301. Contact part; 302. Elastic membrane; 4. Fixing part; 5. Signal transmission part; 6. Energy component; 7. Sensor; 8. Identification component; 801. Buffer plate; 802. Support plate; 803. Rotating plate; 804. Contact plate. Detailed Implementation

[0033] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0034] Example 1

[0035] like Figures 1-4 As shown, a miniature integrated blood glucose monitoring device includes a support component 1 for protecting the device. A contact component 3, which contacts the skin, is connected to one end of the support component 1 to ensure that the support component 1 does not shift position when in contact with the human body, thus ensuring its normal operation. A sealing component 2, which covers the support component 1, is movably mounted on the end of the support component 1 away from the contact component 3. The support component 1 includes a connecting plate 101 for protection, and a connecting cavity 102 within the connecting plate 101 to provide installation space for the component. A control board 103 for data acquisition is connected to the end of the connecting cavity 102 away from the sealing component 2. In use, the contact component 3 contacts the human skin and fixes the position of the support component 1, while the sealing component 2 covers the support component 1, and the control board 103 collects blood glucose data.

[0036] The control board 103 integrates a data preprocessing module, a motion state analysis module, and an energy management module. The data preprocessing module can filter and reduce noise in the raw blood glucose data collected by the sensor 7. To improve the tightness and comfort of the contact component 3 with the human body, the contact component 3 includes a contact part 301 for contact with the skin. A through hole is provided in the contact part 301, and an elastic membrane 302 for preventing liquid from entering is connected in the through hole. Thus, during blood glucose monitoring, the sensor 7 passes through the through hole and through the elastic membrane 302 to contact the human skin. At the same time, when the sensor 7 passes through the elastic membrane 302, the elastic membrane 302 and the sensor 7 are tightly fitted to ensure that no liquid passes through the elastic membrane 302 and that the control board 103 in the connection cavity 102 can be used normally.

[0037] The sensor 7 is a flexible glucose oxidase electrode sensor with a needle tip angle of 30°, which reduces puncture pain by 60%. The sensor 7 is equipped with a micro displacement sensor, which can detect the depth of its insertion into the skin in real time and feed the depth data back to the control board 103. The control board 103 can adjust the depth of the sensor 7 by adjusting the position and height of the sealing component 2 to ensure the stability of contact with tissue fluid.

[0038] Furthermore, to ensure the monitoring device can be used for a long time, an energy component 6 is connected to the end of the enclosure component 2 near the contact component 3 to provide power support for the device. When the enclosure component 2 and the contact component 3 are connected to each other, the energy component 6 contacts the control board 103. At this time, the power in the energy component 6 is released to provide power for the operation of the control board 103. A signal transmission unit 5 for wireless data transmission is connected to the enclosure component 2. The signal transmission unit 5 can collect the data collected by the control board 103 and the sensor 7, and transmit the data to the mobile terminal. The blood glucose data recognized by the mobile terminal is then displayed. The circumference of the energy component 6 is smaller than the circumference of the connecting cavity 102, and the volume of the energy component 6 is smaller than the volume of the connecting cavity 102. That is, during the connection between the enclosure component 2 and the support component 1, the energy component 6 can be housed in the connecting cavity 102 to prevent the energy component 6 from contacting the outside world and affecting its normal use.

[0039] Furthermore, in order to effectively read human blood glucose levels without interfering with human movement, a sensor 7 for blood glucose monitoring is connected to one end of the energy component 6 near the contact component 3. The sensor 7 can contact the tissue fluid under the human skin, thereby identifying and monitoring blood glucose in the tissue fluid to ensure normal blood glucose reading. The data read by the sensor 7 is transmitted to the control board 103. The sensor 7 can pass through the elastic membrane 302 and penetrate the human skin after passing through the elastic membrane 302, so that the sensor 7 can fully monitor changes in human blood glucose levels.

[0040] Furthermore, in order to ensure that the blood glucose monitoring device can be adapted to different installation positions on the human body, a fixing part 4 for secondary constraint of the monitoring device is connected to the supporting component 1. The fixing part 4 is provided with an adhesive layer and is made of medical bandage. First, it contacts the target position on the human body through the contact component 3, and then the fixing part 4 is controlled to extend and contact the human skin to ensure that the fixing part 4 is secondary bonded to the human skin, thereby fixing the monitoring device.

[0041] When in use, the blood glucose monitoring device can be fixed to the user's wrist, abdomen or other easy-to-install parts according to the user's usage habits and work needs. Then, the contact part 301 is connected to the human skin, and the fixing part 4 is connected to the human skin to ensure the stability of the connection plate 101.

[0042] Then, the control unit 2 is connected to the support unit 1, causing the energy component 6 to move into the connection cavity 102. At the same time, the sensor 7 passes through the elastic membrane 302 and comes into contact with the human skin, so that the sensor 7 is located under the human skin. The sensor 7 is used to identify and monitor the changes in blood glucose concentration in the human tissue fluid. After the control unit 2 moves to the preset position of the support unit 1, the energy component 6 comes into contact with the control board 103 and supplies power to the control board 103.

[0043] Furthermore, during the reading process of sensor 7, sensor 7 transmits the monitoring data to control board 103, and then transmits it to mobile terminal through signal transmission unit 5 for user reference.

[0044] Example 2

[0045] However, in the process of monitoring a user's blood glucose using Embodiment 1, it is impossible to completely avoid the contact position between the support component 1 and the human skin being completely fixed, and the sensor 7 being completely perpendicular to the human skin, which causes discomfort to the user during use. Therefore, in order to solve the above problems, the following technical solution is proposed.

[0046] like Figures 5-7 As shown, the connecting plate 101 further has multiple movable slots 1011 for connecting and fixing components on its circumference. Each movable slot 1011 is connected to an identification component 8 for monitoring changes in the condition of human muscle and skin. The number of movable slots 1011 is greater than or equal to four. In this embodiment, the number of movable slots 1011 is preferably four, and they are all arranged in an array around the connecting plate 101 to ensure that the identification component 8 can detect the skin condition to which the supporting component 1 is connected.

[0047] Meanwhile, the motion state analysis module of the control board 103 receives the feedback signal from the identification component 8 and outputs the activity intensity level. The energy management module adjusts the power consumption mode of each component according to the activity intensity level.

[0048] Furthermore, to ensure that the angle of the connecting plate 101 supporting the recognition component 8 remains parallel to the human skin and to reduce the frequency of sensor 7 movement, the recognition component 8 includes a buffer plate 801 for maintaining the stability of the angle of the recognition component 8. The buffer plate 801 is connected to the wall of the movable groove 1011, and a support plate 802 is connected to the buffer plate 801. The support plate 802 extends away from the connecting plate 101, and under the action of the buffer plate 801, the initial state of the support plate 802 is perpendicular to the buffer plate 801. At the same time, the buffer plate 801 is not connected to the connecting plate 101, and the support plate 802 is away from the buffer plate. One end of 801 is rotatably provided with a rotating plate 803, wherein the extension direction of the rotating plate 803 is closer to the side of human skin, and the angle between the rotating plate 803 and the support plate 802 can be adjusted. The end of the rotating plate 803 away from the support plate 802 is connected to a contact plate 804 for contacting human skin. In use, the contact plate 804 can first contact the human skin, thereby adjusting the angle between the rotating plate 803 and the support plate 802 to ensure that the end face of the connecting plate 101 is parallel to the user's skin. Then, the contact part 301 is made to contact the human skin to ensure that the connecting plate 101 is parallel to the human skin.

[0049] Furthermore, in order to ensure the stability of the contact plate 804 during the connection process, an adhesive patch for contacting and fixing with the human body is connected to the end of the contact plate 804 away from the rotating plate 803.

[0050] Furthermore, the bearing assembly 1 is equipped with an identification sensor that can identify the working state of the buffer plate 801. Specifically, the identification sensor can identify and judge the buffering state of the buffer plate 801, and simultaneously identify the user's state by monitoring the movement of the buffer plate 801. This allows for adjustment of the detection frequency of the sensor 7. When the buffer plate 801 exhibits a relatively stable frequency of change, it indicates that the user is engaged in regular movement, and the identification frequency of the control sensor 7 is set to 5 times per minute. When the buffer plate 801 detects abdominal vibrations with uniform but irregular patterns, it indicates that the user is eating, and the identification frequency of the control sensor 7 is increased to 1 time per minute. When the buffer plate 801 exhibits gentle and regular movement, it indicates that the user is sleeping, and the identification frequency of the sensor 7 is adjusted to 10 times per minute. This improves the lifespan of the sensor 7 during use without affecting the user's blood glucose monitoring.

[0051] During installation, first fix the contact plate 804 according to the installation position of the bearing component 1, then adjust the rotation angle between the rotating plate 803 and the support plate 802 so that the connecting plate 101 is parallel to the human skin in the installation area, then control the contact part 301 to fit against the human skin, and then connect the sealing component 2 and the sensor 7.

[0052] The identification component 8 directly contacts the human skin through the fixed adhesive at the end of the contact plate 804, forming a double fixation with the fixing part 4 of the support component 1, which enhances the stability of the device's fit to the skin and prevents the device from shifting due to human movement. Its rotating plate 803 and support plate 802 can rotate relative to each other (rotation angle is 0°-30°), and can adaptively adjust the angle of the contact plate 804 according to the curvature of the skin surface (such as the curvature of different parts such as the wrist and abdomen), ensuring that the contact plate 804 is always in close contact with the skin and reducing local pressure.

[0053] Meanwhile, the built-in strain gauge in the buffer plate 801 can convert the degree of deformation into an electrical signal and transmit it to the motion state analysis module of the control plate 103.

[0054] By measuring the deformation frequency and amplitude, the intensity of user activity is accurately determined, providing a basis for adjusting the monitoring frequency of sensor 7. Simultaneously, the movable slots 1011 of the connecting plate 101 are evenly distributed in a ring (typically 4 groups). The deformation data of the buffer plate 801 of each group of identification components 8 is independently transmitted to the control board 103. The control board 103 compares the 4 groups of data:

[0055] If the difference between any two sets of data is greater than 30%, the determination device is tilted (e.g., the local fit is too loose), and a prompt to "adjust the fit position" is sent to the user terminal through the signal transmission unit 5.

[0056] If the overall deformation amplitude is consistent but the value is high, it is determined that the user is in a continuous activity state, triggering sensor 7 to make a depth fine adjustment to avoid poor contact.

[0057] Furthermore, an angle sensor is built into the rotation axis of the rotating plate 803 to feed back the tilt angle of the contact plate 804 to the control board 103. If the angle of a certain component is greater than 20°, it indicates that the skin tension in that area is too high. The control board 103 will instruct the rotating plates 803 of the other three sets of identification components 8 to make a 5° fine adjustment in the same direction. By dispersing local pressure, the overall fit of the device is improved by 20%, reducing skin redness or pressure marks caused by prolonged wear and improving comfort during use.

[0058] A monitoring method using a miniature integrated blood glucose monitoring device includes the following steps:

[0059] S1. Device initialization: The contact part 301 is attached to the target skin, such as the abdomen, and double-fixed by the fixing part 4 or the identification component 8; the sealing component 2 is fastened to the bearing component 1, the energy component 6 supplies power to the control board 103, the sensor 7 penetrates the elastic membrane 302 and inserts into the skin to an initial depth of 1mm, and the control board 103 self-checks the status of each component, sensor connectivity, and power ≥20% as normal.

[0060] S2. Dynamic Monitoring and Adjustment: The motion state analysis module of control board 103 integrates the acceleration data from the identification sensor and the deformation data from the buffer board 801 to determine the intensity of user activity.

[0061] Resting state: Adjust the sampling frequency of sensor 7 to 10 min / time, and the signal transmission unit 5 enters low power mode to extend the battery life;

[0062] Motion: The sampling frequency was increased to 5 times per minute, and the depth of sensor 7 was maintained at 1 mm to ensure data continuity;

[0063] Feeding: The sampling frequency is increased to once per minute, and the depth of sensor 7 is increased to 1.5 mm by fine-tuning the motor to improve its data accuracy. The initial depth is automatically restored 60 minutes after feeding.

[0064] S3. Data processing and transmission: The raw blood glucose data collected by sensor 7 is filtered by the data preprocessing module of control board 103 to generate blood glucose concentration value; signal transmission unit 5 sends continuous data to mobile terminal via Bluetooth and stores nearly 24 hours of historical data.

[0065] S4. Abnormal Warning and Battery Life Management: When the blood glucose concentration exceeds the preset range, the control board 103 drives the signal transmission unit 5 to send a warning message. The warning method is to use the mobile terminal to vibrate and add a pop-up window. When the battery level is ≤10%, the energy management module automatically switches to the "warning only" mode, stops continuous sampling, and only monitors abnormal values.

[0066] S5. Device disassembly: During disassembly, separate the sealing component 2 from the bearing component 1, pull the sensor 7 out of the elastic membrane 302, and peel off the adhesive on the fixing part 4 or the identification component 8 to complete the disassembly.

[0067] It should be noted that, in this document, the terms “comprising,” “including,” or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such process, method, article, or apparatus.

[0068] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A miniature integrated blood glucose monitoring device, comprising a carrier component (1), characterized in that: One end of the support component (1) is connected to a contact component (3) that comes into contact with the skin. A sealing component (2) is movably provided on the end of the support component (1) away from the contact component (3). The support component (1) includes a connecting plate (101). A connecting cavity (102) is provided in the connecting plate (101). A control plate (103) is connected to the end of the connecting cavity (102) away from the sealing component (2). An energy component (6) is connected to one end of the sealing component (2) near the contact component (3), and a sensor (7) is connected to one end of the energy component (6) near the contact component (3). The contact component (3) includes a contact part (301), and a through hole is provided through the contact part (301), and an elastic membrane (302) is connected inside the through hole. The connecting plate (101) has multiple movable slots (1011) on its circumference, and each movable slot (1011) is connected to an identification component (8). The identification component (8) includes a buffer plate (801) for maintaining the angle stability of the identification component (8). The buffer plate (801) is connected to the groove wall of the movable groove (1011). A support plate (802) is connected to the buffer plate (801). A rotating plate (803) is rotatably provided at one end of the support plate (802) away from the buffer plate (801). An abutment plate (804) is connected at one end of the rotating plate (803) away from the support plate (802). The end of the contact plate (804) away from the rotating plate (803) is provided with a patch for contacting and fixing with the human body; The bearing component (1) is equipped with an identification sensor, which can identify the working state of the buffer plate (801). The identification sensor can identify and judge the buffer state of the buffer plate (801), and at the same time, the identification sensor can identify the user's state by the movement state of the buffer plate (801), thereby adjusting the detection frequency of the sensor (7).

2. The miniature integrated blood glucose monitoring device according to claim 1, characterized in that: The closed component (2) is connected to a signal transmission unit (5), and the perimeter of the energy component (6) is smaller than the perimeter of the connecting cavity (102).

3. The miniature integrated blood glucose monitoring device according to claim 2, characterized in that: The sensor (7) is able to pass through the elastic membrane (302).

4. The miniature integrated blood glucose monitoring device according to claim 2, characterized in that: The support component (1) is provided with a fixing part (4).

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