Diabetes monitoring device and method

Abstract

The application discloses a diabetes monitoring device and method, which comprises a tissue fluid extraction and detection module, an electrochemical controlled release treatment module, a wireless receiving and control circuit module and a power module; the tissue fluid extraction and detection module comprises a tissue fluid extraction module, a glucose colorimetric detection sheet, a detection chamber and an injection micropump; the glucose colorimetric detection sheet is arranged in the detection chamber and is connected with the injection micropump through a hose; the injection micropump collects tissue fluid by providing positive pressure or negative pressure and transports the tissue fluid to the glucose colorimetric detection sheet, so that the glucose concentration in the tissue fluid is rapidly detected; the electrochemical controlled release treatment module comprises an electrochemical drug release electrode, a drug storage chamber and a drug delivery module; the drug storage chamber is filled with a drug solution and is connected with the drug delivery module; the electrochemical drug release electrode is fixed to the top of the drug storage chamber and is in contact with the drug solution; when an electric current is applied to the electrode, the drug solution generates electrolytic reaction to generate gas, the pressure in the drug storage chamber is increased, the drug solution is pushed to be quantitatively released through the drug delivery module, and precise drug delivery is realized.

Description

Technical Field

[0001] This invention relates to the field of biomedical technology, and in particular to a diabetes monitoring device and method. Background Technology

[0002] Diabetes mellitus is a serious chronic metabolic disease, and its long-term complications are one of the leading causes of disability and death in patients. Currently, clinical monitoring of diabetes mainly relies on finger-prick or venous blood sampling to measure blood glucose levels, thereby guiding the dosage of medications such as insulin. However, frequent invasive blood sampling not only causes significant pain and psychological burden for patients but also significantly reduces adherence to long-term monitoring. At the same time, patients often need to inject insulin multiple times a day with a syringe; the cumbersome treatment procedure and the pain from injections further increase treatment barriers. More seriously, an excessive insulin dose can lead to hypoglycemia, endangering life.

[0003] To overcome the pain and risks of traditional blood sampling for blood glucose monitoring, researchers have begun exploring non-invasive blood glucose monitoring methods based on body fluids. While readily available, body fluids such as sweat and saliva have low glucose content and poor correlation with blood glucose levels, limiting their accurate clinical application. In contrast, the glucose concentration in interstitial fluid (ISF) has a high linear correlation with blood glucose levels. Therefore, extracting glucose from percutaneous interstitial fluid is considered an ideal approach for non-invasive blood glucose monitoring, providing more reliable information for dynamic monitoring of diabetic patients. In diabetes drug treatment, microneedling technology has gained widespread attention due to its non-invasive, minimal-volume, and localized advantages. Microneedles can gently penetrate the stratum corneum without touching pain nerve endings, enabling painless transdermal drug delivery. Currently, microneedles are widely used for insulin injection, achieving controllable blood glucose management. Colorimetry, a commonly used method for detecting glucose in interstitial fluid, offers intuitive and visual results, is easy to operate, and also has high biocompatibility. By utilizing a glucose oxidase (GOx) and horseradish peroxidase (HRP) catalytic system and employing chromogenic substrates such as TMB (tetramethylbenzidine, a commonly used chromogenic substrate in biochemical assays), a visual response to glucose concentration can be achieved, providing a new technical approach for real-time monitoring of diabetes. Meanwhile, controlled-release drug delivery technology based on electrolysis reactions has also received widespread attention in recent years. This technology triggers a drug electrolysis reaction by applying current to electrodes, generating gas and creating a driving force to propel the quantitative release of the drug. Compared to traditional mechanical pumps, this method offers advantages such as low power consumption (typically only milliwatts), low thermal effect, and high driving force; furthermore, the drug delivery rate can be flexibly controlled by adjusting the current parameters, demonstrating excellent controllability and promising application prospects.

[0004] Although current methods for diagnosing and treating diabetes are relatively mature, most existing monitoring devices separate diagnosis and treatment, meaning that blood glucose testing and medication must be performed on different devices or at different stages. This separate diagnostic and treatment process is not only more cumbersome and reduces patient compliance, but more importantly, it reduces the timeliness of disease treatment. Furthermore, most existing colorimetric detection methods require transferring extracted tissue fluid to a separate container for testing, a process that is susceptible to contamination, cumbersome, and time-consuming, failing to meet the needs for in vivo, rapid, and continuous monitoring. Therefore, there is an urgent need to develop an integrated diabetes diagnosis and treatment device that combines tissue fluid extraction, glucose colorimetric detection, and controlled-release drug therapy to achieve non-invasive, rapid, and intelligent blood glucose monitoring and personalized medication regulation, providing a new solution for the precise management of diabetes. Summary of the Invention

[0005] The technical problem to be solved by the present invention is to provide a diabetes monitoring device and method that provides drug intervention on demand and in a timely manner based on a detection structure.

[0006] To address the aforementioned technical problems, the first aspect of this invention discloses a diabetes monitoring device, comprising a tissue fluid extraction and detection module, an electrochemical controlled-release therapy module, a wireless receiving and control circuit module, and a power supply module. The tissue fluid extraction and detection module includes a tissue fluid extraction module, a detection chamber, and an injection micropump; The side of the tissue fluid extraction module that contacts the skin of the subject being tested is in contact with the microneedles, which are then inserted into the skin of the subject during operation. The testing chamber extracts skin tissue fluid by providing positive or negative pressure in conjunction with the tissue fluid extraction module, and then delivers it to the testing chamber. A glucose colorimetric detection strip is installed on the inner top of the detection chamber; The top of the detection chamber is connected to an injection micropump via a hose, and the injection micropump is fixed to the top of the tissue fluid extraction and detection module. The electrochemical controlled-release therapy module includes an electrochemical drug release electrode, a drug storage chamber, and a drug delivery module; The drug storage chamber stores the drug solution, and its upper end is connected to the electrochemical drug release electrode, which contacts the drug solution. Its lower end is connected to the drug delivery module. By applying current to the electrochemical drug release electrode, an electrolytic reaction is mediated to generate gas in the drug solution. The increased chamber pressure drives the drug solution to be released from the drug delivery module into the skin of the test subject. The wireless receiving and control circuit module includes a wireless Bluetooth module, a microcontroller, a constant current source module, and a control circuit. The power module is electrically connected to the wireless receiving and control circuit module and the injection micropump, and is used to provide electrical energy.

[0007] As an optional implementation, in the first aspect of the present invention, the tissue fluid extraction module is a hollow microneedle array; the needle body of the hollow microneedle is hollow, and the base of the hollow microneedle is connected to the detection chamber; the hollow microneedle array is uniformly distributed below the detection chamber.

[0008] As an optional implementation, in the first aspect of the present invention, the hollow microneedle is conical, with a bottom width of 450-550 micrometers, a height of 950-1050 micrometers, and a needle tip spacing of 1.9-2.1 millimeters; the hollow pore diameter of the hollow microneedle is 120-130 micrometers.

[0009] As an optional implementation, in the first aspect of the present invention, the detection chamber has a length of 10-11 mm, a width of 10-11 mm, and a height of 500-1000 micrometers.

[0010] As an optional implementation, in the first aspect of the present invention, the glucose colorimetric detection strip is prepared by immersing a paper disc in a solution containing GOx / HRP and TMB.

[0011] As an optional implementation, in the first aspect of the present invention, the electrochemical drug release electrode is placed above the drug storage chamber and in full contact with the drug solution in the drug storage chamber.

[0012] As an optional implementation, in the first aspect of the present invention, the tissue fluid extraction module, the detection chamber, the drug storage chamber, and the drug delivery module of the tissue fluid extraction and detection module are fabricated as a whole using biocompatible resin 3D printing.

[0013] As an optional implementation, in the first aspect of the present invention, the electrochemical drug release electrode is an interdigitated electrode structure with a width of 200 micrometers.

[0014] As an optional implementation, in the first aspect of the present invention, the wireless receiving module uses the 433MHz frequency band and has a power consumption of no more than 12mW; the microcontroller is a single-chip microcomputer with a power consumption of no more than 10mW. The power module uses a 3.7V lithium battery as its power source, and the lithium battery has a capacity of not less than 300 mAh and a charge-discharge cycle count of not less than 100 times; the power module also includes a battery charge-discharge management circuit.

[0015] A second aspect of this invention discloses a method for monitoring diabetes, the method comprising: S1, attach the diabetes monitoring device to the smooth body surface of the subject being tested, so that the tissue fluid extraction module and the drug delivery module come into contact with the body surface; S2, apply pressure to insert the tissue fluid extraction module into the skin; S3, After receiving the start command sent by the control terminal, the wireless Bluetooth module transmits the start command to the microcontroller; The control terminal represents the control terminal used by the operator. The start command represents a start detection instruction; S4. According to the start command, the microcontroller controls the injection micropump to start working, providing negative pressure to the detection chamber, and extracting the tissue fluid in the skin of the subject to be tested into the detection chamber through the tissue fluid extraction module. S5. After the tissue fluid enters the detection chamber, the glucose in the tissue fluid comes into contact with the glucose colorimetric detection strip and is oxidized by the GOx on the glucose colorimetric detection strip to produce hydrogen peroxide. The hydrogen peroxide and the HRP on the glucose colorimetric detection strip catalyze the TMB on the glucose colorimetric detection strip to develop color. S6, the TMB colorimetric assay is identified using the control terminal to obtain the tissue fluid glucose concentration; S7, based on the glucose concentration of tissue fluid, when the blood glucose is higher than the preset threshold, the microcontroller automatically activates the electrochemical controlled release therapy module, provides current to the electrochemical drug release electrode, triggers the electrolysis reaction of the drug solution, increases the pressure in the drug storage chamber, and drives the drug solution to be released from the drug delivery module.

[0016] Compared with the prior art, the embodiments of the present invention have the following beneficial effects: 1. This invention uses hollow microneedles with negative pressure to extract tissue fluid, achieving safe, rapid, and controlled extraction of tissue fluid in a micro-volume, localized manner, avoiding the safety risks associated with blood draws and the limitations of accuracy in sweat testing.

[0017] 2. This invention uses a colorimetric method to detect glucose, which has the advantages of being rapid, convenient, and visual, while avoiding the biosafety risks and stability issues associated with the use of electrolytes in electrochemical detection.

[0018] 3. This invention uses hollow microneedles for transdermal drug delivery, which effectively avoids the pain and risk of infection from needle pricks caused by traditional needle injections, significantly improving the safety of drug delivery and patient comfort, and has wider clinical applicability.

[0019] 4. This invention uses an electrolytically driven method to release drugs, which not only has advantages such as low power consumption (usually only milliwatt level), low thermal effect and high driving force, but more importantly, the drug release rate can be flexibly controlled by simply adjusting the current amplitude applied to the electrochemical drug release electrode, so as to achieve a precise and controllable drug delivery process.

[0020] 5. This invention uses a wireless receiving module to receive, process, and output signals, enabling remote control functionality. It allows for diagnosis and treatment without the recipient being aware of the procedure, thus avoiding discomfort for the recipient. Attached Figure Description

[0021] To more clearly illustrate the technical solutions in the embodiments of the present invention, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0022] Figure 1 This is a schematic diagram of the structure of a diabetes monitoring device disclosed in an embodiment of the present invention; Figure 2 This is a schematic diagram of a tissue fluid extraction hollow microneedle and a drug release hollow microneedle disclosed in an embodiment of the present invention; Figure 3 This is a flowchart of a transceiver and control circuit module disclosed in an embodiment of the present invention.

[0023] Figure labels and descriptions: 1-Tissue fluid extraction and detection module; 2-Electrochemical control and treatment module; 3-Wireless receiving and control circuit module; 4-Power supply module; 5-Tissue fluid extraction module; 6-Glucose colorimetric detection strip; 7-Detection chamber; 8-Injection micropump; 9-Ventilation port; 10-Drug delivery module; 11-Electrochemical drug release electrode; 12-Drug storage chamber; 13-Wireless Bluetooth module; 14-Microcontroller; 15-Constant current source module. Detailed Implementation

[0024] To enable those skilled in the art to better understand the present invention, the technical solutions of the present invention will be clearly and completely described below with reference to the accompanying drawings of the embodiments of the present invention. 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.

[0025] The terms "first," "second," etc., used in the specification, claims, and accompanying drawings of this invention are used to distinguish different objects, not to describe a specific order. Furthermore, the terms "comprising" and "having," and any variations thereof, are intended to cover non-exclusive inclusion. For example, a process, method, apparatus, product, or device that includes a series of steps or units is not limited to the listed steps or units, but may optionally include steps or units not listed, or may optionally include other steps or units inherent to these processes, methods, products, or devices.

[0026] In this document, the term "embodiment" means that a particular feature, structure, or characteristic described in connection with an embodiment may be included in at least one embodiment of the invention. The appearance of this phrase in various places throughout the specification does not necessarily refer to the same embodiment, nor is it a separate or alternative embodiment mutually exclusive with other embodiments. It will be explicitly and implicitly understood by those skilled in the art that the embodiments described herein can be combined with other embodiments.

[0027] In all embodiments of the present invention, the variables involved in all computational expressions or mathematical functions have been dimensionlessized before computation.

[0028] In all embodiments of the present invention, the values ​​of the independent variables in the input of all computational expressions or mathematical functions meet the reasonable requirements of the input range of the computational expressions or mathematical functions, and can ensure that the computational expressions or mathematical functions can be calculated smoothly without violating physical laws or mathematical rules.

[0029] This invention discloses a diabetes monitoring device and method, comprising a tissue fluid extraction and detection module, an electrochemical controlled-release therapy module, a wireless receiving and control circuit module, and a power supply module. The tissue fluid extraction and detection module includes a tissue fluid extraction module, a glucose colorimetric detection strip, a detection chamber, and an injection micropump. The glucose colorimetric detection strip is placed in the detection chamber and connected to the injection micropump via a tubing. The injection micropump collects tissue fluid by providing positive or negative pressure and delivers it to the glucose colorimetric detection strip, rapidly detecting the glucose concentration in the tissue fluid. The electrochemical controlled-release therapy module includes an electrochemical drug release electrode, a drug storage chamber, and a drug delivery module. The drug storage chamber contains a drug solution and is connected to the drug delivery module. The electrochemical drug release electrode is fixed to the top of the drug storage chamber and contacts the drug solution. When current is applied to the electrode, the drug solution undergoes an electrolytic reaction to generate gas, increasing the pressure in the drug storage chamber and propelling the drug solution through the drug delivery module for quantitative release, achieving precise drug administration. Detailed descriptions follow.

[0030] Example 1 Please see Figure 1 , Figure 1 This is a schematic diagram of the structure of a diabetes monitoring device disclosed in an embodiment of the present invention. Figure 1The described diabetes monitoring device is applied in the field of biomedical technology, and the embodiments of this invention are not limited thereto. Figure 1 As shown, the diabetes monitoring device includes a tissue fluid extraction and detection module, an electrochemical controlled-release therapy module, a wireless receiving and control circuit module, and a power supply module; The tissue fluid extraction and detection module includes a tissue fluid extraction module, a detection chamber, and an injection micropump; The side of the tissue fluid extraction module that contacts the skin of the subject being tested is in contact with the microneedles, which are then inserted into the skin of the subject during operation. The testing chamber extracts skin tissue fluid by providing positive or negative pressure in conjunction with the tissue fluid extraction module, and then delivers it to the testing chamber. A glucose colorimetric detection strip is installed on the inner top of the detection chamber; The top of the detection chamber is connected to an injection micropump via a hose, and the injection micropump is fixed to the top of the tissue fluid extraction and detection module. The electrochemical controlled-release therapy module includes an electrochemical drug release electrode, a drug storage chamber, and a drug delivery module; The drug storage chamber stores the drug solution, and its upper end is connected to the electrochemical drug release electrode, which contacts the drug solution. Its lower end is connected to the drug delivery module. By applying current to the electrochemical drug release electrode, an electrolytic reaction is mediated to generate gas in the drug solution. The increased chamber pressure drives the drug solution to be released from the drug delivery module into the skin of the test subject. The wireless receiving and control circuit module includes a wireless Bluetooth module, a microcontroller, a constant current source module, and a control circuit. The power module is electrically connected to the wireless receiving and control circuit module and the injection micropump, and is used to provide electrical energy.

[0031] Optionally, the tissue fluid extraction module is a hollow microneedle array; the body of the hollow microneedle is hollow, and the base of the hollow microneedle is connected to the detection chamber; the hollow microneedle array is evenly distributed below the detection chamber.

[0032] Optionally, the hollow microneedle is conical, with a bottom width of 450–550 micrometers, a height of 950–1050 micrometers, and a tip-to-tip distance of 1.9–2.1 millimeters; the hollow pore diameter of the hollow microneedle is 120–130 micrometers.

[0033] Optionally, the detection chamber has a length of 10-11 mm, a width of 10-11 mm, and a height of 500-1000 micrometers.

[0034] Optionally, the glucose colorimetric detection strip is prepared by immersing a paper disc in a solution containing GOx / HRP and TMB.

[0035] Optionally, the drug storage chamber has a length of 10-11 mm, a width of 10-11 mm, and a height of 500-1000 micrometers. The drug storage chamber stores the drug solution, and the electrochemical drug release electrode is connected above it.

[0036] Optionally, the electrochemical drug release electrode is placed above the drug storage chamber to fully contact the drug solution inside the storage chamber.

[0037] Optionally, the tissue fluid extraction module, detection chamber, drug storage chamber of the electrochemical control therapy module, and drug delivery module of the tissue fluid extraction and detection module are fabricated as a whole using biocompatible resin 3D printing.

[0038] Optionally, the electrochemical drug release electrode is an interdigitated electrode structure with a width of 200 micrometers.

[0039] Optionally, the wireless receiving module uses the 433MHz frequency band and has a power consumption of no more than 12mW; the microcontroller is a single-chip microcomputer with a power consumption of no more than 10mW. The power module uses a 3.7V lithium battery as its power source, and the lithium battery has a capacity of not less than 300 mAh and a charge-discharge cycle count of not less than 100 times; the power module also includes a battery charge-discharge management circuit.

[0040] Figure 2 This is a schematic diagram of a tissue fluid extraction hollow microneedle and a drug release hollow microneedle disclosed in an embodiment of the present invention; Figure 3 This is a flowchart of a transceiver and control circuit module disclosed in an embodiment of the present invention.

[0041] Example 2 This embodiment discloses a method for monitoring diabetes, the method comprising: S1, attach the diabetes monitoring device to the smooth body surface of the subject being tested, so that the tissue fluid extraction module and the drug delivery module come into contact with the body surface; S2, apply pressure to insert the tissue fluid extraction module into the skin; S3, After receiving the start command sent by the control terminal, the wireless Bluetooth module transmits the start command to the microcontroller; The control terminal represents the control terminal used by the operator. The start command represents a start detection instruction; S4. According to the start command, the microcontroller controls the injection micropump to start working, providing negative pressure to the detection chamber, and extracting the tissue fluid in the skin of the subject to be tested into the detection chamber through the tissue fluid extraction module. S5. After the tissue fluid enters the detection chamber, the glucose in the tissue fluid comes into contact with the glucose colorimetric detection strip and is oxidized by the GOx on the glucose colorimetric detection strip to produce hydrogen peroxide. The hydrogen peroxide and the HRP on the glucose colorimetric detection strip catalyze the TMB on the glucose colorimetric detection strip to develop color. S6, the TMB colorimetric assay is identified using the control terminal to obtain the tissue fluid glucose concentration; S7, based on the glucose concentration of tissue fluid, when the blood glucose is higher than the preset threshold, the microcontroller automatically activates the electrochemical controlled release therapy module, provides current to the electrochemical drug release electrode, triggers the electrolysis reaction of the drug solution, increases the pressure in the drug storage chamber, and drives the drug solution to be released from the drug delivery module.

[0042] Example 3 Please see Figure 1 . Figure 1 This is a schematic diagram of a diabetes monitoring device disclosed in an embodiment of the present invention. Figure 1 The present invention discloses a diabetes monitoring device, comprising a tissue fluid extraction and detection module, an electrochemical controlled-release therapy module, and a wireless receiving and control circuit module and a power supply module fixed on top of both. The tissue fluid extraction and detection module is used to extract and detect skin tissue fluid from the surface of the subject. The electrochemical controlled-release therapy module automatically releases a drug solution based on the detection results, providing timely intervention to the subject. The wireless receiving and control circuit module receives instructions from a control terminal to control the tissue fluid extraction and detection module to automatically complete tissue fluid extraction and detection, and triggers the electrochemical controlled-release therapy module to automatically release the stored drug solution. The control terminal represents the control terminal used by the operator. The control terminal is equipped with a camera and glucose colorimetric detection software, which can automatically identify the colorimetric detection results and monitor the dynamic changes in glucose concentration in the tissue fluid after drug administration in real time, thereby realizing closed-loop blood glucose management from detection, intervention to feedback.

[0043] The tissue fluid extraction and detection module includes a tissue fluid extraction module 5, a glucose colorimetric detection strip 6, a detection chamber 7, and an injection micropump 8. During operation, the tissue fluid extraction module is attached to the surface of the subject. When tissue fluid extraction is required, the tissue fluid extraction module is inserted into the body surface. The detection chamber is connected to the tissue fluid extraction module. A vent 9 is located at the top of the detection chamber, and the vent is connected to the injection micropump via a flexible tube (not shown in the figure). The injection micropump is fixed to the top. The injection micropump provides negative pressure to the detection chamber. Once the detection chamber is under negative pressure, the tissue fluid is extracted into the detection chamber through the tissue fluid extraction module.

[0044] A glucose colorimetric detection strip is installed at the top of the detection chamber; a detection strip replacement port is provided on the side of the detection chamber, which allows the old detection strip to be removed and a new detection strip to be inserted.

[0045] The electrochemical control therapy module includes a drug delivery module 10, an electrochemical drug release electrode 11, and a drug storage chamber 12. The bottom surface represents the side that contacts the skin of the subject being tested. During operation, the drug delivery module is applied to the surface of the subject being tested. When drug delivery is required, the drug delivery module is inserted into the surface of the body. The drug delivery module is provided with the drug storage chamber and the electrochemical drug release electrode. By applying current to the electrochemical drug release electrode, the drug solution is triggered to undergo electrolysis, driving the drug solution to be released from the drug delivery module and delivered into the skin of the subject being tested.

[0046] The wireless receiving and control circuit module 3 and the power supply module 4 are fixed to the top of the device. The wireless receiving and control circuit module is electrically connected to the injection micropump, the electrochemical drug release electrode, and the power supply module via a flexible flat cable. The wireless receiving and control circuit module is used to receive user commands, and the control device performs tissue fluid extraction and detection according to a preset program.

[0047] The main functional chips of the transceiver and control circuit module 3 are a wireless Bluetooth module 13, a microcontroller 14, and a constant current source module 15; the microcontroller is electrically connected to the wireless Bluetooth module; the wireless Bluetooth module is used to receive wireless control commands from the control terminal; the control terminal represents the control terminal used by the operator.

[0048] The power module 4 is electrically connected to the wireless receiving and control circuit module and the injection micropump, providing power to the device.

[0049] Therefore, the diabetes health device described in this example extracts tissue fluid using negative pressure and combines it with colorimetric glucose detection. This achieves safe, rapid, and controllable extraction and detection of tissue fluid in a micro-volume, localized manner, effectively solving the safety risks associated with traditional blood draws and the insufficient accuracy of sweat testing. Simultaneously, the device employs an electrochemical controlled-release combined with hollow microneedles for transdermal drug delivery, enabling on-demand drug release in a non-invasive, safe, and intelligent manner. This simplifies the drug administration process, improves patient compliance, and avoids health risks caused by overdose or underdose.

[0050] Example 4 like Figure 2 As shown, the tissue fluid extraction module 5 and the drug delivery module 10 are hollow microneedle arrays; the hollow microneedle array includes M×N hollow microneedles; the needle body of the hollow microneedle is hollow, the base of the hollow microneedle of the tissue fluid extraction module is connected to the detection chamber, and the hollow microneedle array is evenly distributed below the detection chamber; the base of the hollow microneedle array of the drug delivery module is connected to the drug storage chamber, and the hollow microneedle array is evenly distributed below the drug storage chamber; the value of M ranges from 6 to 12, and the value of N ranges from 6 to 12.

[0051] like Figure 2 As shown, the hollow microneedle array uses a 6×12 hollow microneedle sequence, which can meet the amount of tissue fluid required for detection and the need to alleviate the symptoms of diabetes, while not causing discomfort to the subject being sampled.

[0052] Optionally, the hollow microneedle is conical, with a bottom width of 450–550 micrometers, a height of 950–1050 micrometers, and a tip-to-tip distance of 1.9–2.1 millimeters; the hollow pore diameter of the hollow microneedle is 120–250 micrometers, and the distance between the center of the pore and the center of the hollow microneedle is 120–130 micrometers.

[0053] Preferably, the hollow microneedle has a bottom width of 500 micrometers and a height of 1000 micrometers; the center-to-center spacing of the hollow microneedle array is 1 millimeter; the hollow aperture of the hollow microneedle is 200 micrometers, and the distance between the center of the aperture and the center of the hollow microneedle is 125 micrometers.

[0054] Optionally, the detection chamber 9 has a length of 10-11 mm, a width of 10-11 mm, and a height of 500-1000 micrometers.

[0055] Preferably, the length and width of the detection chamber are both 11 mm, and the height is 500 micrometers.

[0056] Optionally, the glucose colorimetric detection strip 6 is made by immersing a paper disc in 5 mL of a solution containing 625 U / L GOX / HRP (glucose oxidase / horseradish peroxidase) and 3.33 mM TMB (…). The solution was prepared by drying the aqueous solution of tetramethylbenzidine (-tetramethylbenzidine) for 5 min at room temperature for 2 h.

[0057] Optionally, the glucose colorimetric detection strip has a length of 10-11 mm and a width of 10-11 mm.

[0058] Preferably, the glucose colorimetric detection strip 104 has a length of 10 mm and a width of 10 mm.

[0059] It should be noted that the tissue fluid glucose colorimetric detection device described in this example uses the glucose colorimetric detection strip provided in this embodiment, which is convenient to use and can quickly and accurately complete the detection of glucose.

[0060] Example 5 This embodiment provides a diabetes monitoring method, applied to the diabetes monitoring device disclosed in Embodiment 1 of the present invention, the method comprising: The diabetes monitoring device is attached to the smooth skin of the subject being tested, so that the tissue fluid extraction module and the drug delivery module come into contact with the skin. Apply pressure to insert the microneedle array into the skin; like Figure 3As shown, the wireless receiving module in the wireless receiving and control circuit module receives the start command sent by the control terminal and transmits it to the microcontroller. The control terminal represents the control terminal used by the operator; the start command represents the start detection instruction. According to the start command, the microcontroller controls the injection micropump to start working, providing negative pressure to the detection chamber, and extracting tissue fluid from the tissue fluid extraction module into the detection chamber from the skin of the subject being tested. In the testing chamber, a glucose colorimetric test strip reacts with tissue fluid. The glucose in the tissue fluid is oxidized by glucose oxidase (GOx) on the glucose colorimetric test strip to produce hydrogen peroxide. The hydrogen peroxide and HRP (horseradish peroxidase) on the glucose test strip jointly catalyze the formation of TMB (transferase) on the glucose test strip. (-Tetramethylbenzidine) color development; The system receives color development signals using a camera at the control terminal, processes and converts the signals using software, and outputs the measured glucose concentration. If blood sugar is too high, the microcontroller in the wireless receiver control circuit module automatically activates the electrochemical controlled release therapy module, providing current to its electrochemical drug release electrode, triggering the drug solution in the drug storage chamber to undergo an electrolytic reaction and generate gas; The gas generated during solution electrolysis increases the pressure in the drug storage chamber. The increased pressure drives the drug solution to be released from the drug delivery module, thus achieving transdermal drug delivery.

[0061] As can be seen, the technical solution provided in this application achieves controlled extraction and real-time detection of tissue fluid through a non-invasive, micro-volume, and localized method, and intelligently regulates the release of hypoglycemic drugs based on the detection results. This device combines high safety and high precision, avoiding the invasive risks of blood sampling and the inaccuracies of sweat testing. It enables dynamic monitoring and timely intervention of blood glucose, effectively preventing health risks caused by improper blood glucose control.

[0062] The device embodiments described above are merely illustrative. The modules described as separate components may or may not be physically separate, and the components shown as modules may or may not be physical modules; that is, they may be located in one place or distributed across multiple network modules. Some or all of the modules can be selected to achieve the purpose of this embodiment according to actual needs. Those skilled in the art can understand and implement this without any creative effort.

[0063] Through the detailed description of the above embodiments, those skilled in the art can clearly understand that each implementation method can be implemented by means of software plus necessary general-purpose hardware platforms, and of course, it can also be implemented by hardware. Based on this understanding, the above technical solutions, in essence or the part that contributes to the prior art, can be embodied in the form of a software product. This computer software product can be stored in a computer-readable storage medium, including read-only memory (ROM), random access memory (RAM), programmable read-only memory (PROM), erasable programmable read-only memory (EPROM), one-time programmable read-only memory (OTPROM), electrically-erasable programmable read-only memory (EEPROM), compact disc read-only memory (CD-ROM) or other optical disc storage, disk storage, magnetic tape storage, or any other computer-readable medium that can be used to carry or store data.

[0064] Finally, it should be noted that the method and apparatus for rapid processing of optical data in key areas disclosed in the embodiments of the present invention are merely preferred embodiments of the present invention and are only used to illustrate the technical solutions of the present invention, not to limit it. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A diabetes monitoring device, characterized in that, It includes a tissue fluid extraction and detection module, an electrochemical controlled-release therapy module, a wireless receiving and control circuit module, and a power supply module; The tissue fluid extraction and detection module includes a tissue fluid extraction module, a detection chamber, and an injection micropump; The side of the tissue fluid extraction module that contacts the skin of the subject being tested is in contact with the microneedles, which are then inserted into the skin of the subject during operation. The testing chamber extracts skin tissue fluid by providing positive or negative pressure in conjunction with the tissue fluid extraction module, and then delivers it to the testing chamber. A glucose colorimetric detection strip is installed on the inner top of the detection chamber; The top of the detection chamber is connected to an injection micropump via a hose, and the injection micropump is fixed to the top of the tissue fluid extraction and detection module. The electrochemical controlled-release therapy module includes an electrochemical drug release electrode, a drug storage chamber, and a drug delivery module; The drug storage chamber stores the drug solution, and its upper end is connected to the electrochemical drug release electrode, which contacts the drug solution. Its lower end is connected to the drug delivery module. By applying current to the electrochemical drug delivery electrode, an electrolytic reaction is mediated to generate gas, and the increased chamber pressure drives the drug to be released from the drug delivery module into the skin of the test subject. The wireless receiving and control circuit module includes a wireless Bluetooth module, a microcontroller, a constant current source module, and a control circuit. The power module is electrically connected to the wireless receiving and control circuit module and the injection micropump, and is used to provide electrical energy.

2. The diabetes monitoring device according to claim 1, characterized in that, The tissue fluid extraction module is a hollow microneedle array; the body of the hollow microneedle is hollow, and the base of the hollow microneedle is connected to the detection chamber; The hollow microneedle array is evenly distributed below the detection chamber.

3. The diabetes monitoring device according to claim 2, characterized in that, The hollow microneedle is conical in shape, with a bottom width of 450–550 micrometers, a height of 950–1050 micrometers, and a tip-to-tip distance of 1.9–2.1 millimeters; the hollow pore diameter of the hollow microneedle is 120–130 micrometers.

4. The diabetes monitoring device according to claim 1, characterized in that, The detection chamber has a length of 10-11 mm, a width of 10-11 mm, and a height of 500-1000 micrometers.

5. The diabetes monitoring device according to claim 1, characterized in that, The glucose colorimetric detection strip is prepared by immersing a paper disc in a solution containing GOx / HRP and TMB.

6. The diabetes monitoring device according to claim 1, characterized in that, The electrochemical drug release electrode is positioned above the drug storage chamber, ensuring full contact with the drug solution within the chamber.

7. The diabetes monitoring device according to claim 1, characterized in that, The tissue fluid extraction module, detection chamber, drug storage chamber of the electrochemical control therapy module, and drug delivery module of the tissue fluid extraction and detection module are fabricated as a whole using biocompatible resin 3D printing.

8. The diabetes monitoring device according to claim 1, characterized in that, The electrochemical drug release electrode has an interdigitated electrode structure with a width of 200 micrometers.

9. The diabetes monitoring device according to claim 1, characterized in that, The wireless receiving module uses the 433MHz frequency band and has a power consumption of no more than 12mW; the microcontroller is a single-chip microcomputer with a power consumption of no more than 10mW. The power module uses a 3.7V lithium battery as its power source, and the lithium battery has a capacity of not less than 300 mAh and a charge-discharge cycle count of not less than 100 times; the power module also includes a battery charge-discharge management circuit.

10. A method for monitoring diabetes, applied to any one of the diabetes monitoring devices described in claims 1 to 9, characterized in that, The method includes: S1, attach the diabetes monitoring device to the smooth body surface of the subject being tested, so that the tissue fluid extraction module and the drug delivery module come into contact with the body surface; S2, apply pressure to insert the tissue fluid extraction module into the skin; S3, After receiving the start command sent by the control terminal, the wireless Bluetooth module transmits the start command to the microcontroller; The control terminal represents the control terminal used by the operator. The start command represents a start detection instruction; S4. According to the start command, the microcontroller controls the injection micropump to start working, providing negative pressure to the detection chamber, and extracting the tissue fluid in the skin of the subject to be tested into the detection chamber through the tissue fluid extraction module. S5. After the tissue fluid enters the detection chamber, the glucose in the tissue fluid comes into contact with the glucose colorimetric detection strip and is oxidized by the GOx on the glucose colorimetric detection strip to produce hydrogen peroxide. The hydrogen peroxide and the HRP on the glucose colorimetric detection strip catalyze the TMB on the glucose colorimetric detection strip to develop color. S6, the TMB colorimetric assay is identified using the control terminal to obtain the tissue fluid glucose concentration; S7, based on the glucose concentration of tissue fluid, when the blood glucose is higher than the preset threshold, the microcontroller automatically activates the electrochemical controlled release therapy module, provides current to the electrochemical drug release electrode, triggers the electrolysis reaction of the drug solution, increases the pressure in the drug storage chamber, and drives the drug solution to be released from the drug delivery module.

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