Wearable non-invasive non-invasive continuous blood glucose monitoring equipment

Abstract

The invention relates to the technical field of blood glucose monitoring equipment, and particularly discloses wearable non-invasive non-invasive continuous blood glucose monitoring equipment which comprises a shell, the shell is used for being worn on the auricle, the shell comprises a surrounding part and an attaching part, the surrounding part is arranged in a hollow annular pipe with an opening, and the attaching part is arranged on the surrounding part. The two fitting parts are mounted at the opening position of the surrounding part; the laser light source is mounted in one of the fitting parts; the ultrasonic transducer is arranged in the attaching part far away from the laser light source, and the laser light source and the ultrasonic transducer are oppositely arranged; the data processing module is used for collecting, analyzing and processing the photoacoustic signals to obtain blood glucose data. The portable blood glucose monitoring device has the ear wearing function, the gravity applied to the ear by the blood glucose monitoring device is reduced, the trouble in the injection and infusion process of a patient by medical staff is avoided, the blood glucose monitoring effect is improved, and the power consumption is lower and the energy is saved.

Description

Technical Field

[0001] The present invention relates to the technical field of blood glucose monitoring equipment, and in particular to a wearable non-invasive continuous blood glucose monitoring device. Background Art

[0002] Blood glucose monitoring is an important part of diabetes management. Its purpose is to help patients better control their blood glucose levels, thereby reducing the risk of complications. When conducting blood glucose monitoring, it is necessary to pay attention to choosing the appropriate monitoring method and frequency, and adjust according to the doctor's advice. For example, in patients using insulin or insulin pump therapy, a higher monitoring frequency may be required to ensure safety and treatment effectiveness. At the same time, the monitoring results should be comprehensively evaluated in combination with other health indicators such as blood pressure and blood lipids to fully understand the health status of diabetic patients.

[0003] The Chinese patent (CN202023040210.3) discloses a portable dynamic continuous blood glucose monitor, comprising a shell; a display screen located on the outer surface of the shell; a first strap arranged on one side of the shell; a second strap arranged on the other side of the shell, the second strap being movably connected to the first strap through a connecting component; a first infrared detection component; a second infrared detection component; a data processing module located outside the shell, the data processing module comprising a signal processing circuit respectively connected to the first infrared receiving sensor and the second infrared receiving sensor, a processor for analyzing data, and a memory for storing data; a control and calculation module, whose input end is connected to the data processing module.

[0004] However, there are some drawbacks in the above-mentioned related technologies. For example, some existing continuous blood glucose monitors are usually worn on the arm for blood glucose monitoring during use. If they are worn too tightly, it is easy to sweat. If they are worn too loosely, the monitor is easy to shake with the movement of the arm, resulting in unstable data dynamics. Wearing the monitor on the arm makes it inconvenient for medical staff to inject and infuse patients. Since arm blood usually refers to venous blood, it is far less suitable for blood glucose monitoring than ear blood, resulting in poor blood glucose monitoring effect. The power consumption of the two infrared receiving sensors is relatively high. Summary of the invention

[0005] In order to solve the above problems existing in the prior art, the present invention provides a wearable non-invasive continuous blood glucose monitoring device, which can solve the problems raised in the above background technology.

[0006] The purpose of the present invention can be achieved through the following technical solutions: A wearable non-invasive continuous blood glucose monitoring device comprises a shell, the shell is used to be worn on the auricle, the shell comprises a surrounding part and a fitting part, the surrounding part is arranged in a hollow ring tube with an opening, and two fitting parts are installed at the opening positions of the surrounding part; A laser light source, wherein the laser light source is installed in one of the bonding parts; An ultrasonic transducer, wherein the ultrasonic transducer is installed in a bonding portion away from the laser light source, and the laser light source and the ultrasonic transducer are placed opposite to each other; A data processing module, used for collecting, analyzing and processing the photoacoustic signal to obtain blood glucose data, the data processing module includes a pre-filter amplifier circuit, an analog-to-digital converter, a microcontroller and a wireless communication device; A battery module, wherein the battery module is used for storing and supplying electricity; Metal pillars, two of which are installed through the outer wall of the surrounding part, the two metal pillars are electrically connected to the battery module, and the metal pillars are matched with a dedicated charging storage box.

[0007] Preferably, the shell is made of carbon fiber material, and the outer wall of the shell is provided with a gel layer or a silicone layer.

[0008] Preferably, the inner wall of the surrounding portion is provided with two limiting members, and the data processing module is installed between the two limiting members.

[0009] Preferably, the battery module includes an assembly shell and a shell cover, the assembly shell and the shell cover are fixedly connected by fasteners, the assembly shell is coaxially arranged with the surrounding portion, the inner wall of the assembly shell is provided with a plurality of partitions distributed in an array, the assembly shell is divided into a plurality of assembly spaces by the plurality of partitions, and battery cells are arranged in the plurality of assembly spaces of the assembly shell.

[0010] Preferably, a plurality of first heat dissipation holes are arranged on the concave side of the assembly shell, and a plurality of second heat dissipation holes are arranged on the convex side of the assembly shell.

[0011] Preferably, the inner wall of the surrounding portion is provided with two limit blocks, and the battery module is installed between the two limit blocks.

[0012] Preferably, the outer wall of the surrounding portion is provided with two snap-in holes, and the snap-in holes match the metal column.

[0013] Preferably, the inner wall of the surrounding portion is provided with a ferromagnetic block, and the ferromagnetic block matches the dedicated charging storage box.

[0014] Preferably, the data processing module is made of a special stretchable flexible material, and the devices on the data processing module are respectively provided with a packaging structure.

[0015] Preferably, the maximum pulse power consumption of the laser light source is 100 mw, and the average skin irradiation power is less than 1 mw / mm 2 .

[0016] The beneficial effects of the present invention are: 1. By setting a shell, the beneficial effect that can be obtained is that the shell is made of carbon fiber material, the shell is used to be worn on the auricle, the shell includes a surrounding part and a fitting part, the surrounding part is arranged as a hollow ring tube with an opening, two fitting parts are installed at the opening positions of the surrounding part, the laser light source is installed in one of the fitting parts, the ultrasonic transducer is installed in the fitting part away from the laser light source, the laser light source and the ultrasonic transducer are placed opposite to each other, and a data processing module is used to collect, analyze and process the photoacoustic signal to obtain blood sugar data, and the data processing module includes a pre-filter amplifier circuit, an analog-to-digital converter, a microcontroller and a wireless communication device; The shell is worn on the auricle, and the laser light source cooperates with the ultrasonic transducer to collect photoacoustic signals from the auricle blood vessels. The collected photoacoustic signals are processed by the data processing module: pre-processed by the pre-filter amplifier circuit, and then converted into digital signals by the analog-to-digital converter, and sent to the microcontroller. A simple software filtering algorithm runs in the microcontroller to process the original data again, and then the measurement data is sent to the terminal device through a wireless communication device, such as low-power Bluetooth technology. The terminal device can be a small portable device with certain computing power, such as a smart watch / bracelet, mobile phone, personal computer, etc. The terminal device runs a pre-trained machine learning algorithm and uses statistical methods to perform principal component analysis to calculate the blood sugar value at the current auricle measurement position and present it on the human-computer interaction interface. It has the function of being worn on the ear, which avoids the trouble of medical staff for injection and infusion of patients.

[0017] 2. By setting the battery module, the beneficial effect that can be obtained is that the battery module is used for storing and supplying electricity, the battery module includes an assembly shell and a shell cover, the assembly shell and the shell cover are fixedly connected by fasteners, the assembly shell and the surrounding part are coaxially arranged, the inner wall of the assembly shell is provided with a plurality of partitions distributed in an array, the assembly shell is divided into a plurality of assembly spaces by the plurality of partitions, and the plurality of assembly spaces of the assembly shell are all provided with battery units; A plurality of battery cells are arranged in a circular array and electrically connected to form a battery module, which matches the cavity of the outer shell, thereby reducing the space occupied by the battery module, reducing the volume of the outer shell, and reducing the gravity exerted by the blood glucose monitoring device on the ear.

[0018] 3. By arranging the laser light source and the ultrasonic transducer, the beneficial effect that can be obtained is that the housing includes a surrounding portion and a fitting portion, the surrounding portion is arranged as a hollow ring tube with an opening, the two fitting portions are installed at the opening positions of the surrounding portion, the laser light source is installed in one of the fitting portions, the ultrasonic transducer is installed in the fitting portion away from the laser light source, and the laser light source and the ultrasonic transducer are placed opposite to each other; The device adopts the transmission method. The design of this device takes into account the possibility of interference of impurities in the blood and other skin dirt on the measurement results. It adopts a dual-wavelength design. In addition to the light source used to measure glucose, another band of light source is also prepared. When calculating blood sugar, the photoacoustic signal of the other light source is directly subtracted from the result to eliminate interference and effectively improve the accuracy of the measurement results. The error of the device is within 10mg / dl, the measurement range is 50-300mg / dl, the maximum pulse power consumption of the laser light source is 100mw, and the average skin irradiation power is less than 1mw / mm 2 , it is completely harmless to the human body. At the same time, the operating power of the distributed feedback laser used is lower than that of general lasers, so the power consumption of the equipment is also at a low level. The laser light source adopts medium-wave infrared laser. When in use, the surrounding part cooperates with the two fitting parts to clamp the auricle. The laser emitted by the laser light source is collimated by a microprism and directly reaches the auricle. The medium-wave infrared penetrates into the interstitial fluid 40-50 microns under the skin. The laser wavelength is consistent with the vibration frequency of the glucose molecules therein. The pressure wave generated after the vibration is excited is received by the ultrasonic transducer placed on the opposite side, thereby generating a photoacoustic signal. The glucose in the interstitial fluid comes directly from the blood, and the diffusion speed of the ear from the blood is extremely fast, which can be considered as direct feedback of blood sugar, which improves the blood sugar monitoring effect and is more energy-saving with low power consumption. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] In order to facilitate understanding by those skilled in the art, the present invention is further described below with reference to the accompanying drawings.

[0020] Figure 1 It is a schematic diagram of the overall structure of the present invention; Figure 2 This is a diagram of the installation structure of the laser light source in the present invention; Figure 3 The data processing module and the battery module of the present invention are installed in the structure diagram; Figure 4 This is a diagram of the installation structure of the laser light source and the ultrasonic transducer in the present invention; Figure 5 This is a diagram of the installation structure of the position limiting member and the data processing module in the present invention; Figure 6 This is a diagram of the installation structure of the battery module in the present invention; Figure 7 It is a structural diagram of the assembly shell and the shell cover in the present invention; Figure 8 It is the installation structure diagram of the assembly shell and the partition in the present invention.

[0021] Description of reference numerals: In the figure: 1. outer shell; 11. surrounding part; 12. fitting part; 2. laser light source; 3. ultrasonic transducer; 4. data processing module; 41. limiting member; 5. battery module; 51. assembly shell; 52. shell cover; 53. partition; 54. battery unit; 55. first heat dissipation hole; 56. second heat dissipation hole; 57. limiting block; 6. metal column; 61. snap-in hole; 62. ferromagnetic block. DETAILED DESCRIPTION

[0022] In order to further explain the technical means and effects adopted by the present invention to achieve the predetermined invention purpose, the specific implementation methods, structures, features and effects of the present invention are clearly and completely described below in combination with the accompanying drawings and preferred embodiments. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of them. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0023] In the description of the present application, it should be understood that the orientation or position relationship indicated by "inside", "outside", etc. is based on the orientation or position described in the drawings, which is only for the convenience of describing the present application and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, a specific orientation structure and operation, and therefore cannot be understood as a limitation on the present application.

[0024] Reference Figure 1-8 , a wearable non-invasive continuous blood glucose monitoring device disclosed in the present invention, includes a shell 1, the shell 1 is made of carbon fiber material, the shell 1 is used to be worn on the auricle, the outer wall of the shell 1 is provided with a gel layer or a silicone layer, the shell 1 includes a surrounding portion 11 and a fitting portion 12, the surrounding portion 11 is provided in the form of a hollow ring tube with an opening, and two fitting portions 12 are installed at the opening position of the surrounding portion 11.

[0025] Laser light source 2, laser light source 2 is installed in one of the fitting parts 12, the maximum pulse power consumption of laser light source 2 is 100 mw, and the average skin irradiation power is less than 1 mw / mm 2 .

[0026] The design of this device takes into account the possibility that impurities in the blood and other skin dirt may interfere with the measurement results. A dual-wavelength design is adopted. In addition to the light source used to measure glucose, a light source of another wavelength is also prepared. When calculating blood sugar, the photoacoustic signal of the other light source is directly subtracted from the result to eliminate interference and effectively improve the accuracy of the measurement results. The error of the device is within 10mg / dl, the measurement range is 50-300mg / dl, the maximum pulse power consumption of laser light source 2 is 100mw, and the average skin irradiation power is less than 1mw / mm 2It is completely harmless to the human body. At the same time, the operating power of the distributed feedback laser used is lower than that of general lasers, so the power consumption of the equipment is also at a lower level.

[0027] The ultrasonic transducer 3 is installed in the fitting portion 12 away from the laser light source 2, and the laser light source 2 and the ultrasonic transducer 3 are placed opposite to each other.

[0028] The data processing module 4 is used to collect, analyze and process the photoacoustic signals to obtain blood glucose data. Two limit members 41 are provided on the inner wall of the surrounding portion 11. The data processing module 4 is installed between the two limit members 41. The data processing module 4 includes a pre-filter amplifier circuit, an analog-to-digital converter, a microcontroller and a wireless communication device. The data processing module 4 is made of a special stretchable flexible material, and the devices on the data processing module 4 are respectively provided with packaging structures.

[0029] The battery module 5 is used for storing and supplying electricity. The battery module 5 includes an assembly shell 51 and a shell cover 52. The assembly shell 51 and the shell cover 52 are fixedly connected by fasteners. The assembly shell 51 is coaxially arranged with the surrounding portion 11. The inner wall of the assembly shell 51 is provided with a plurality of partitions 53 distributed in an array. The assembly shell 51 is divided into a plurality of assembly spaces by the plurality of partitions 53. Battery units 54 are arranged in the plurality of assembly spaces of the assembly shell 51. A plurality of first heat dissipation holes 55 are arranged on the concave side of the assembly shell 51. A plurality of second heat dissipation holes 56 are arranged on the convex side of the assembly shell 51. Two limit blocks 57 are arranged on the inner wall of the surrounding portion 11. The battery module 5 is installed between the two limit blocks 57.

[0030] Metal pillars 6, two metal pillars 6 are installed through the outer wall of the surrounding part 11, the two metal pillars 6 are electrically connected to the battery module 5, the metal pillars 6 match the dedicated charging storage box, the outer wall of the surrounding part 11 is provided with two snap-in holes 61, the snap-in holes 61 match the metal pillars 6, the inner wall of the surrounding part 11 is provided with ferromagnetic blocks 62, and the ferromagnetic blocks 62 match the dedicated charging storage box.

[0031] The working principle and use process of the present invention are as follows: the device uses the photoacoustic principle, the shell 1 is worn on the auricle, the laser light source 2 cooperates with the ultrasonic transducer 3 to collect the photoacoustic signal from the auricle blood vessels, and the collected photoacoustic signal is processed by the data processing module 4: the pre-filter amplifier circuit pre-processes, and then the analog-to-digital converter converts it into a digital signal, and then sends it to the microcontroller. The microcontroller runs a simple software filtering algorithm to process the original data again, and then sends the measurement data to the terminal device through a wireless communication device, such as low-power Bluetooth technology. The terminal device can be a small portable device with certain computing power, such as a smart watch / bracelet, a mobile phone, a personal computer, etc. The terminal device runs a pre-trained machine learning algorithm and performs principal component analysis using statistical methods to calculate the blood sugar value at the current auricle measurement position and present it on the human-computer interaction interface. It has the function of being worn on the ear, avoiding the trouble of medical staff in injecting and infusing patients.

[0032] The above-mentioned device serves as the front-end part of the continuous non-invasive blood glucose collection system. It is powered by a rechargeable battery module 5 and has the function of timed wake-up to collect photoacoustic data. During the non-collection period, it maintains an ultra-low power consumption state to extend the battery life. When the device is low on power or there is an abnormality, it will be identified by the internal abnormal diagnosis circuit and reported to the terminal device. The device is charged by magnetic attraction. The special charging box cooperates with the ferromagnetic block 62 on the outer shell 1 for magnetic attraction. The card hole 61 assists the special charging box to fit with the outer shell 1. The special charging storage box cooperates with the metal column 6 for charging. The storage box charging circuit uses a fast charging protocol to reduce the charging time and avoid affecting the time resolution of the continuous blood glucose measurement results.

[0033] In terms of photoacoustic signal measurement, the equipment adopts a transmission method, and the laser light source 2 uses a medium-wave infrared laser. When in use, the surrounding part 11 cooperates with the two fitting parts 12 to clamp the auricle. The laser emitted by the laser light source 2 is collimated by a microprism and directly reaches the auricle. The medium-wave infrared penetrates into the interstitial fluid 40-50 microns under the skin. The laser wavelength is consistent with the vibration frequency of the glucose molecules therein. The pressure wave generated after the vibration is excited is received by the ultrasonic transducer 3 placed on the opposite side, thereby generating a photoacoustic signal. The glucose in the interstitial fluid comes directly from the blood, and the diffusion speed from the blood is extremely fast, which can be considered as a direct feedback of blood sugar.

[0034] The above description is only a preferred embodiment of the present invention and does not limit the present invention in any form. Although the present invention has been disclosed as a preferred embodiment as above, it is not used to limit the present invention. Any technical personnel in this field can make some changes or modify the technical contents disclosed above into equivalent embodiments without departing from the scope of the technical solution of the present invention. However, any brief modifications, equivalent changes and modifications made to the above embodiments based on the technical essence of the present invention without departing from the content of the technical solution of the present invention still fall within the scope of the technical solution of the present invention.

Claims

1. A wearable non-invasive continuous blood glucose monitoring device, characterized in that: include; A shell (1), the shell (1) being used to be worn on an auricle, the shell (1) comprising a surrounding portion (11) and a fitting portion (12), the surrounding portion (11) being in the form of a hollow ring tube with an opening, and two fitting portions (12) being mounted at the openings of the surrounding portion (11); A laser light source (2), the laser light source (2) being installed in one of the fitting portions (12); An ultrasonic transducer (3), the ultrasonic transducer (3) being installed in a bonding portion (12) away from the laser light source (2), the laser light source (2) and the ultrasonic transducer (3) being placed opposite to each other; A data processing module (4) is used to collect, analyze and process the photoacoustic signal to obtain blood sugar data, the data processing module (4) comprising a pre-filter amplifier circuit, an analog-to-digital converter, a microcontroller and a wireless communication device; A battery module (5), the battery module (5) being used for storing and supplying electricity; Metal columns (6), two of the metal columns (6) are installed through the outer wall of the surrounding portion (11), the two metal columns (6) are electrically connected to the battery module (5), and the metal columns (6) match the dedicated charging storage box.

2. A wearable non-invasive continuous blood glucose monitoring device according to claim 1, characterized in that: The shell (1) is made of carbon fiber material, and the outer wall of the shell (1) is provided with a gel layer or a silicone layer.

3. A wearable non-invasive continuous blood glucose monitoring device according to claim 1, characterized in that: The inner wall of the surrounding portion (11) is provided with two limiting members (41), and the data processing module (4) is installed between the two limiting members (41).

4. A wearable non-invasive continuous blood glucose monitoring device according to claim 1, characterized in that: The battery module (5) comprises an assembly shell (51) and a shell cover (52); the assembly shell (51) and the shell cover (52) are fixedly connected by fasteners; the assembly shell (51) and the surrounding portion (11) are coaxially arranged; the inner wall of the assembly shell (51) is provided with a plurality of partitions (53) distributed in an array; the assembly shell (51) is divided into a plurality of assembly spaces by the plurality of partitions (53); and battery cells (54) are arranged in each of the plurality of assembly spaces of the assembly shell (51).

5. A wearable non-invasive continuous blood glucose monitoring device according to claim 4, characterized in that: A plurality of first heat dissipation holes (55) are provided on the concave side of the assembly shell (51), and a plurality of second heat dissipation holes (56) are provided on the convex side of the assembly shell (51).

6. A wearable non-invasive continuous blood glucose monitoring device according to claim 4, characterized in that: The inner wall of the surrounding portion (11) is provided with two limit blocks (57), and the battery module (5) is installed between the two limit blocks (57).

7. A wearable non-invasive continuous blood glucose monitoring device according to claim 1, characterized in that: The outer wall of the surrounding portion (11) is provided with two clamping holes (61), and the clamping holes (61) match the metal column (6).

8. A wearable non-invasive continuous blood glucose monitoring device according to claim 1, characterized in that: The inner wall of the surrounding portion (11) is provided with a ferromagnetic block (62), and the ferromagnetic block (62) matches a dedicated charging storage box.

9. A wearable non-invasive continuous blood glucose monitoring device according to claim 1, characterized in that: The data processing module (4) is made of a special stretchable flexible material, and the devices on the data processing module (4) are respectively provided with a packaging structure.

10. A wearable non-invasive continuous blood glucose monitoring device according to claim 1, characterized in that: The maximum pulse power consumption of the laser light source (2) is 100 mw, and the average skin irradiation power is less than 1 mw / mm 2 .

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