Miniature integrated blood glucose monitoring device and monitoring method thereof

Abstract

The invention belongs to the technical field of medical instruments, and discloses a miniature integrated blood glucose monitoring device and a monitoring method thereof, in particular to a miniature integrated blood glucose monitoring device which comprises a bearing assembly, and one end of the bearing assembly is connected with an abutting assembly in contact with skin; the end, away from the abutting assembly, of the bearing assembly is movably provided with a sealing assembly, the bearing assembly comprises a connecting plate, a connecting cavity is formed in the connecting plate, and the end, away from the sealing assembly, of the connecting cavity is connected with a control plate. The angle of the abutting plate is adaptively adjusted according to the skin curved surface, and tight attachment is ensured; the buffer plate is connected to the movable groove wall, deformation of the buffer plate is captured by the recognition sensor, whether the device is inclined or not is judged in cooperation with the control panel, the components cooperatively reduce displacement caused by human body movement, meanwhile, local pressure is dispersed, skin pressure is reduced, and wearing stability and comfort are improved.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and in particular relates to a micro-integrated blood glucose monitoring device and a monitoring method thereof. Background Art

[0002] Blood glucose monitoring is of great significance to diabetic patients. Accurate and stable monitoring can help patients grasp the changes in their condition in a timely manner, take corresponding treatment measures, and reduce the occurrence of chronic complications.

[0003] Patent application number 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 attached to the skin of the treatment area, the sensor assembly detects the amount of glucose passing through the skin in the sterile positioning patch area, and the signal transmitter wirelessly transmits the signal sensed by the sensor assembly to a monitor. All components of the present invention are disposable, convenient and hygienic, with small product specifications and easy to carry. There is no need to clean the components after use, which simplifies the operation and avoids cross infection during detection. The monitoring data is transmitted to the monitor in real time by wireless communication, which can realize uninterrupted dynamic monitoring of the blood glucose data of diabetic patients so that monitoring personnel can remotely track the blood glucose concentration level of diabetic patients. It is very convenient for both daily testing of users and monitoring personnel. Although the above scheme realizes continuous monitoring of blood glucose, the blood glucose monitoring device often shifts due to human activities when worn, resulting in a loose fit with the skin, which not only affects the accuracy of the monitoring data, but also may cause discomfort to the patient due to excessive local pressure.

[0004] At the same time, some devices are unable to dynamically adjust the monitoring frequency according to the patient's activity status. Either high-frequency monitoring leads to excessive energy consumption, or low-frequency monitoring misses key blood sugar change data. When the device is tilted or the sensor depth is inappropriate, timely feedback and adjustment cannot be made, which brings many inconveniences to patients' daily use.

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

[0006] The purpose of the present invention is to address the above problems. The present invention provides a micro-integrated blood glucose monitoring device and a monitoring method thereof, which have the advantage of regulating the state of the blood glucose monitoring device according to the user's usage status.

[0007] To achieve the above-mentioned object, the present invention provides the following technical solution: a miniature integrated blood glucose monitoring device, comprising a carrier assembly, one end of which is connected to a resistance assembly for contact with the skin, and an end of which is remote from the resistance assembly and movably provided with a closure assembly, the carrier assembly including a connecting plate, the connecting plate defining a connecting cavity, the end of which is remote from the closure assembly and connected to a control board; The resistance component includes a resistance portion, a through hole is formed through the resistance portion, and an elastic membrane is connected in the through hole.

[0008] Preferably, an energy component is connected to one end of the closing component close to the interference component, a signal transmission part is connected to the closing component, and the circumference of the energy component is smaller than the circumference of the connecting cavity.

[0009] Preferably, a sensor is connected to one end of the energy component close to the interference component, and the sensor can pass through the elastic membrane.

[0010] Preferably, a fixing portion is connected to the carrying assembly.

[0011] Preferably, a plurality of movable grooves are provided on the circumference of the connecting plate, and identification components are connected to each of the movable grooves.

[0012] Preferably, the identification component includes a buffer plate, the buffer plate is connected to the groove wall of the movable groove, the buffer plate is connected to a support plate, the support plate is rotatably provided with a rotating plate at one end away from the buffer plate, and the rotating plate is connected to a contact plate at one end away from the support plate.

[0013] Preferably, an end of the contact plate away from the rotating plate is connected to a patch for contacting and fixing with a human body.

[0014] Preferably, an identification sensor is connected to the bearing assembly to identify the working status of the buffer plate.

[0015] A monitoring method, using a micro-integrated blood glucose monitoring device, comprises the following steps: S1. The contact part is placed against the target skin, fixed by the fixing part or the identification component, the sealing component is fastened to the bearing component, the energy component is powered, the sensor penetrates the skin through the elastic membrane, and the control board self-checks the component status; S2, the control board integrates the recognition sensor acceleration and the buffer plate deformation data to determine the activity intensity; S3: The raw data from the sensor is filtered by the control board to generate the blood glucose value; the signal transmission unit transmits the data to the terminal via Bluetooth and stores the historical data; S4: When blood sugar exceeds the preset range, the signal transmission unit will issue an early warning; when the battery level is ≤10%, it will switch to the "alarm only" mode; S5. Unlock and separate the parts by pressing the closed component, pull out the sensor, and tear off the fixing part or the identification component to complete the disassembly.

[0016] Compared with the prior art, the present invention has the following beneficial effects: 1. Through the identification component, the rotating plate and the support plate can rotate, and the angle of the contact plate is adaptively adjusted according to the skin curve to ensure a close fit; the buffer plate is connected to the movable groove wall, and its deformation is captured by the identification sensor, which cooperates with the control board to determine 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.

[0017] 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 determines the intensity of the user's activity. The control board then links the sensor to adjust accordingly. The sensor's micro-displacement sensor provides real-time feedback on the depth, and the control board dynamically adjusts to maintain contact with the tissue fluid. The coordination of multiple components greatly improves data accuracy in different scenarios. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Figure 1 This is a schematic diagram of the overall structure of the first embodiment of the present invention; Figure 2 Schematic diagram of the cross-sectional structure of the overall structure of the first embodiment of the present invention; Figure 3 A schematic diagram of the connection structure of the interference assembly of the present invention; Figure 4 Schematic diagram of the connection structure of the sensor of the present invention; Figure 5 This is a schematic diagram of the overall structure of the second embodiment of the present invention; Figure 6 A schematic diagram of the connection structure of the identification components of the present invention; Figure 7 This is a schematic cross-sectional structural diagram of the identification component of the present invention.

[0019] Description of the drawings: 1. Carrying component; 101. Connecting plate; 1011. Movable groove; 102. Connecting cavity; 103. Control board; 2. Closing component; 3. Interference component; 301. Interference 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. Interference plate. DETAILED DESCRIPTION

[0020] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of the present invention.

[0021] Example 1

[0022] like Figures 1-4 As shown, a miniature integrated blood glucose monitoring device includes a carrier component 1 for protecting the device, and a resistance component 3 that contacts the skin is connected to one end of the carrier component 1, so as to ensure that the carrier component 1 will not be positionally shifted when the monitoring device contacts the human body, ensuring its normal use. A closing component 2 for sealing the carrier component 1 is movably provided on the end of the carrier component 1 away from the resistance component 3, wherein the carrier component 1 includes a connecting plate 101 for protection, and a connecting cavity 102 for providing an installation space for the component is opened in the connecting plate 101, and a control board 103 for collecting data is connected to the end of the connecting cavity 102 away from the closing component 2. When in use, the resistance component 3 contacts the human skin and fixes the position of the carrier component 1, and the closing component 2 is used to seal the carrier component 1, and the control board 103 is used to collect blood glucose data.

[0023] 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 on 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 portion 301 for contacting the human skin. The contact portion 301 is provided with a through hole, and an elastic membrane 302 is connected to the through hole to prevent liquid from entering. During the blood glucose monitoring process, the sensor 7 passes through the through hole and 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, ensuring that no liquid passes through the elastic membrane 302, ensuring the normal use of the control board 103 in the connecting cavity 102.

[0024] Sensor 7 is a flexible glucose oxidase electrode sensor with a needle tip bevel angle of 30°, which reduces the puncture pain by 60%. A micro-displacement sensor is installed inside sensor 7, which can detect the depth of its penetration into the skin in real time and feed back the depth data to the control board 103. The control board 103 can adjust the depth of sensor 7 by adjusting the position height of the sealing component 2 to ensure the stability of contact with the tissue fluid.

[0025] Furthermore, in order to ensure that the monitoring device can be used for a long time, an energy component 6 that provides power support for the device is connected to one end of the closing component 2 close to the interference component 3. When the closing component 2 and the interference component 3 are connected to each other, the energy component 6 conflicts with the control board 103. At this time, the power in the energy component 6 is released, providing a power source for the operation of the control board 103. A signal transmission unit 5 for wireless data transmission is connected to the closing component 2. The signal transmission unit 5 can collect data collected by the control board 103 and the sensor 7, and use the signal transmission unit 5 to transmit the data to the mobile terminal, and display the blood glucose data recognized by the mobile terminal. 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, in the process of connecting the closing component 2 and the carrying component 1, the energy component 6 can be stored in the connecting cavity 102 to prevent the energy component 6 from contacting the outside world and affecting the normal use of the energy component 6.

[0026] Furthermore, in order to be able to effectively read the human blood sugar without interfering with the movement of the human body, a sensor 7 for blood sugar monitoring is connected to one end of the energy component 6 close to the resistance component 3. At the same time, the sensor 7 can contact the tissue fluid under the human skin, and then the blood sugar in the tissue fluid is identified and monitored by the sensor 7 to ensure normal reading of blood sugar, and 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 the changes in the human blood sugar.

[0027] Furthermore, in order to ensure that the blood glucose monitoring device can adapt to the installation positions in different areas of the human body, a fixing part 4 for secondary restraint of the monitoring device is connected to the supporting component 1, wherein an adhesive layer is connected to the fixing part 4, and the fixing part 4 is composed of a medical bandage. It first contacts the target position of the human body through the resistance component 3, and then controls the extension of the fixing part 4 to contact the human skin, ensuring that the fixing part 4 is secondary bonded to the human skin to achieve fixation of the monitoring device.

[0028] During use, according to the user's usage habits and work needs, the blood glucose monitoring device can be fixed on the user's wrist, abdomen or other parts that are easy to install, and then the resistance part 301 is connected to the human skin, and the fixing part 4 is used to contact and connect with the human skin to ensure that the position of the connecting plate 101 is stable.

[0029] Then, the closing component 2 is controlled to connect with the carrying component 1, prompting the energy component 6 to move into the connecting cavity 102, and at the same time prompting the sensor 7 to pass through the elastic membrane 302 and contact the human skin, so that the sensor 7 is located on the lower side of 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 closing component 2 moves to the preset position of the carrying component 1, the energy component 6 contacts the control board 103 and supplies power to the control board 103.

[0030] Furthermore, during the reading process of the sensor 7, the sensor 7 transmits the monitoring data to the control board 103 and transmits it to the mobile terminal through the signal transmission unit 5 for the user's reference.

[0031] Example 2

[0032] However, in the process of monitoring the user's blood sugar using Example 1, it is impossible to completely avoid the supporting component 1 and the human skin from being completely fixed in contact position, and the sensor 7 is completely perpendicular to the human skin, which causes discomfort to the user during use. In order to solve the above problem, the following technical solution is proposed.

[0033] like Figure 5-Figure 7 As shown, further, a plurality of movable grooves 1011 for connecting and fixing components are opened on the circumference of the connecting plate 101, and the movable grooves 1011 are connected with identification components 8 for monitoring changes in the muscle and skin conditions of the human body, wherein the number of the movable grooves 1011 is greater than or equal to four. In this embodiment, the number of the movable grooves 1011 is preferably four, and they are distributed in an array around the connecting plate 101, so as to ensure that the identification component 8 can detect the skin condition to which the supporting component 1 is connected.

[0034] At the same time, the motion state analysis module of the control board 103 receives the feedback signal of the recognition component 8 and outputs the activity intensity level, and the energy management module adjusts the power consumption mode of each component according to the activity intensity level.

[0035] Furthermore, in order to ensure that the angle of the identification component 8 supporting the connecting plate 101 is always parallel to the human skin and reduce the movement frequency of the sensor 7, the identification component 8 includes a buffer plate 801 for maintaining the stability of the angle 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. The support plate 802 extends to the side away from the connecting plate 101, and under the action of the buffer plate 801, the initial state of the support plate 802 is in a vertical state with 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 A rotating plate 803 is rotatably provided at one end of 801, wherein the extending direction of the rotating plate 803 is close to the side of the 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 resistance plate 804 for contacting the human skin. When in use, the resistance plate 804 can first be used to 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, and then the resistance part 301 is prompted to contact the human skin to ensure that the connecting plate 101 is parallel to the human skin.

[0036] Furthermore, in order to ensure the stability of the contact plate 804 during the connection process, an application patch for contacting and fixing with the human body is connected to one end of the contact plate 804 away from the rotating plate 803 .

[0037] Furthermore, an identification sensor is connected to the carrier component 1, which can identify the working status of the buffer plate 801, that is, the identification sensor can be used to identify and judge the buffering status of the buffer plate 801, and at the same time, the identification sensor can be used to identify the user's status by the movement status of the buffer plate 801, thereby adjusting the detection frequency of the sensor 7. When the buffer plates 801 are in a relatively stable frequency of change, it means that the user is exercising regularly. At this time, the identification frequency of the control sensor 7 is 5min\times. When the buffer plate 801 detects that the abdomen is in the same amplitude but irregular pattern, it means that the user is in an eating state. The identification frequency of the control sensor 7 is increased and adjusted to 1min\time. When the buffer plate 801 is in a smooth and regular movement, it means that the user is in a sleeping state. The identification frequency of the sensor 7 is adjusted to 10min\times, thereby increasing the service life of the sensor 7 during use and at the same time will not affect the user's blood sugar monitoring.

[0038] During installation, first fix the resistance plate 804 according to the installation position of the supporting component 1, and then adjust the rotation angle between the rotating plate 803 and the supporting plate 802 so that the connecting plate 101 is parallel to the human skin in the installation area, and then control the resistance part 301 to fit the human skin, and then connect the closing component 2 and the sensor 7.

[0039] The identification component 8 is in direct contact with the human skin through the fixed adhesive patch at the end of the contact plate 804, and cooperates with the fixing part 4 of the supporting component 1 to form a double fixation, thereby enhancing the stability of the fit between the device and the skin and avoiding the displacement of the device due to human activities. Its rotating plate 803 and the support plate 802 can rotate relative to each other (the 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 curved surfaces 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.

[0040] At the same time, the buffer plate 801 has a built-in strain gauge that can convert the degree of deformation into an electrical signal and transmit it to the motion state analysis module of the control board 103.

[0041] The user's activity intensity is accurately judged by the deformation frequency and amplitude, providing a basis for adjusting the monitoring frequency of the sensor 7. At the same time, the movable grooves 1011 of the connecting plate 101 are evenly distributed in a ring shape (usually 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: If the difference between any two sets of data is greater than 30%, it is determined that the device is tilted (e.g., the bonding is partially too loose), and a prompt "adjust the bonding position" is sent to the user terminal via the signal transmission unit 5; If the overall deformation amplitude is consistent but the value is too high, it is determined that the user is in a state of continuous activity, and the sensor 7 is triggered to perform deep fine-tuning to avoid poor contact.

[0042] An angle sensor built into the rotating shaft of the rotating plate 803 feeds back the tilt angle of the contact plate 804 to the control board 103. If the angle of a component exceeds 20°, it indicates excessive skin tension in that area. The control board 103 then instructs the rotating plates 803 of the other three sets of recognition components 8 to make a fine 5° adjustment in the same direction. This disperses local pressure, improving the overall fit of the device by 20%, reducing redness or indentation caused by prolonged wear and enhancing user comfort.

[0043] A monitoring method, using a micro-integrated blood glucose monitoring device, comprises the following steps: S1. Device initialization: The resistance part 301 is placed against the target skin, such as the abdomen, and is doubly fixed by the fixing part 4 or the fixing adhesive application of the identification component 8; the sealing component 2 is buckled with the carrying component 1, the energy component 6 supplies power to the control board 103, and the sensor 7 penetrates the skin through the elastic membrane 302 to an initial depth of 1mm. The control board 103 self-checks the status of each component sensor and checks that the connectivity and power level are ≥20% for normal.

[0044] S2. Dynamic monitoring and adjustment: The motion state analysis module of the control board 103 integrates the acceleration data of the recognition sensor and the deformation data of the buffer board 801 to determine the intensity of the user's activity: Resting state: adjust the sampling frequency of sensor 7 to 10 minutes per time, and the signal transmission unit 5 enters low power consumption mode to extend the battery life; Movement: The sampling frequency is increased to 5 minutes per time, and the sensor depth is maintained at 1mm to ensure data continuity; Eating: The sampling frequency is increased to 1 minute per time. At the same time, the depth of sensor 7 is increased to 1.5mm by fine-tuning the motor to improve its data accuracy. The initial depth is automatically restored 60 minutes after the end of eating.

[0045] S3. Data processing and transmission: The raw blood glucose data collected by the sensor 7 is filtered by the data pre-processing module of the control board 103 to generate a blood glucose concentration value; the signal transmission unit 5 sends a continuous data to the mobile terminal via Bluetooth and stores the historical data of the past 24 hours.

[0046] S4. Abnormal warning and endurance 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, and the warning method uses the mobile terminal to vibrate and add a pop-up window; when the power level is ≤10%, the energy management module automatically switches to the "warning only" mode, stops continuous sampling, and only monitors abnormal values.

[0047] S5. Device disassembly: During disassembly, the sealing component 2 and the carrying component 1 are separated, the sensor 7 is pulled out from the elastic membrane 302, and the fixing portion 4 or the identification component 8 is torn off to complete the disassembly.

[0048] It should be noted that, in this article, the terms "comprises", "includes" or any other variations thereof are intended to cover non-exclusive inclusion, so that a process, method, article or apparatus that includes a series of elements includes not only those elements, but also includes other elements not explicitly listed, or also includes elements that are inherent to such process, method, article or apparatus.

[0049] While embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions, and variations may be made to these embodiments without departing from the principles and spirit of the invention, and that the scope of the invention is defined by the appended claims and their equivalents.

Claims

1. A miniature integrated blood glucose monitoring device, comprising a carrier assembly (1), characterized in that: One end of the carrier component (1) is connected to a resistance component (3) that contacts the skin, and an end of the carrier component (1) away from the resistance component (3) is movably provided with a closing component (2). The carrier component (1) comprises a connecting plate (101), a connecting cavity (102) is provided in the connecting plate (101), and a control panel (103) is connected to the end of the connecting cavity (102) away from the closing component (2); The interference component (3) comprises an interference portion (301), a through hole is provided through the interference portion (301), and an elastic membrane (302) is connected to the through hole.

2. The micro integrated blood glucose monitoring device according to claim 1, characterized in that: An energy component (6) is connected to one end of the closing component (2) close to the abutting component (3), and a signal transmission portion (5) is connected to the closing component (2). The circumference of the energy component (6) is smaller than the circumference of the connecting cavity (102).

3. The micro integrated blood glucose monitoring device according to claim 2, characterized in that: A sensor (7) is connected to one end of the energy component (6) close to the resistance component (3), and the sensor (7) is capable of passing through the elastic membrane (302).

4. The micro integrated blood glucose monitoring device according to claim 2, wherein: A fixing portion (4) is connected to the bearing assembly (1).

5. The micro integrated blood glucose monitoring device according to claim 2, characterized in that: A plurality of movable grooves (1011) are provided on the circumference of the connecting plate (101), and identification components (8) are connected to each of the movable grooves (1011).

6. The micro-integrated blood glucose monitoring device according to claim 5, characterized in that: The identification component (8) comprises a buffer plate (801), the buffer plate (801) being connected to the groove wall of the movable groove (1011), a support plate (802) being connected to the buffer plate (801), a rotating plate (803) being rotatably provided at one end of the support plate (802) away from the buffer plate (801), and a contact plate (804) being connected to one end of the rotating plate (803) away from the support plate (802).

7. The micro integrated blood glucose monitoring device according to claim 6, characterized in that: An end of the resistance plate (804) away from the rotating plate (803) is connected to a patch for contacting and fixing with a human body.

8. The micro integrated blood glucose monitoring device according to claim 7, characterized in that: An identification sensor is connected inside the bearing assembly (1) and is capable of identifying the working state of the buffer plate (801).

9. A monitoring method, using the micro-integrated blood glucose monitoring device according to any one of claims 1 to 8, characterized in that: The following steps are involved: S1. The resistance part (301) is attached to the target skin and fixed by the fixing part (4) or the identification component (8) through a fixed adhesive application. The sealing component (2) is fastened to the bearing component (1). The energy component (6) supplies power. The sensor (7) penetrates the elastic membrane (302) and penetrates the skin. The control panel (103) self-checks the component status. S2, the control board (103) fuses the acceleration of the recognition sensor and the deformation data of the buffer board (801) to determine the intensity of the activity; S3, the raw data of the sensor (7) is filtered by the control board (103) to generate a blood glucose value; the signal transmission unit (5) transmits the data to the terminal via Bluetooth and stores historical data; S4: When the blood sugar exceeds the preset range, the signal transmission unit (5) issues an early warning; when the battery level is ≤10%, the system switches to the "alarm only" mode; S5. Press the closure component (2) to unlock and separate the components, pull out the sensor (7), and tear off the fixing portion (4) or the identification component (8) to complete the disassembly.

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