Closed-loop non-invasive insulin detection and precise infusion system

Abstract

The invention relates to the technical field of intelligent diabetes treatment instruments, in particular to a closed-loop non-invasive insulin detection and precise infusion system which is characterized by comprising a blood glucose monitoring regulator, a non-invasive injector and a closed-loop control mechanism. The closed-loop control mechanism comprises a real-time blood glucose detection module, a temperature detection module, a blood glucose data processing module, a dose decision module, an injection pressure adjusting module, an injection channel control module, an insulin injection module and a closed-loop feedback module; noninvasive and high-sensitivity real-time blood glucose monitoring is achieved, the accuracy and timeliness of insulin administration are improved through trend prediction and individualized dose decision, meanwhile, multi-nozzle array piezoelectric needleless injection is combined with temperature compensation pressure regulation and a closed loop feedback correction mechanism, local tissue burden is effectively reduced, and the insulin administration efficiency is improved. And through multiple safety protection and wireless data transmission, remote monitoring and intelligent management are realized, so that the convenience, accuracy and reliability of blood glucose management of diabetic patients are greatly improved.

Description

Technical Field

[0001] This invention relates to the field of intelligent treatment devices for diabetes, specifically to a closed-loop non-invasive insulin detection and precision infusion system. Background Technology

[0002] With the increasing number of diabetic patients year by year, dynamic blood glucose monitoring and personalized insulin administration have become important aspects of diabetes management. Traditional blood glucose monitoring methods mainly rely on finger-prick blood sampling, which has the disadvantages of cumbersome operation, limited monitoring frequency and insufficient real-time performance, making it difficult to meet the needs of continuous blood glucose monitoring in clinical and daily life. In recent years, continuous glucose monitoring (CGM) has gradually developed, but existing systems generally have problems such as limited sensor accuracy, complex calibration process, poor wearing comfort and unstable data transmission, making it difficult to balance high accuracy and convenience.

[0003] While traditional insulin pens and pump injections are widely used for insulin delivery, they suffer from drawbacks such as concentrated burden on the injection site, frequent needle replacements, and insufficient precision in controlling injection volume. Furthermore, existing insulin pumps typically rely on fixed-dose or simple threshold-based control logic, lacking the ability to predict future blood glucose trends and are prone to delayed or overdosing risks. Most existing intelligent drug delivery systems are fragmented in the sensing, prediction, and delivery stages, lacking an integrated closed-loop optimization scheme and failing to fully meet the comprehensive needs for high-sensitivity monitoring, accurate prediction, and safe and efficient drug delivery. To address these issues, we propose a closed-loop non-invasive insulin detection and precision infusion system. Summary of the Invention

[0004] To address the shortcomings of existing technologies, this invention provides a closed-loop non-invasive insulin detection and precise infusion system, solving the problems mentioned in the background art.

[0005] The above-mentioned technical objective of the present invention is achieved through the following technical solution:

[0006] A closed-loop, non-invasive insulin detection and precision infusion system, including:

[0007] A blood glucose monitoring and regulation device is used to continuously acquire glucose concentration data in the subcutaneous tissue fluid of subjects and perform closed-loop blood glucose regulation.

[0008] Non-invasive injectors are used to automatically administer insulin injections based on blood glucose monitoring data.

[0009] The closed-loop control mechanism includes: a real-time blood glucose detection module, a temperature detection module, a blood glucose data processing module, a dose decision module, an injection pressure adjustment module, an injection channel control module, an insulin injection module, and a closed-loop feedback module. The closed-loop control mechanism dynamically calculates the injection dose and adjusts the injection pressure based on blood glucose concentration and temperature signals, and achieves precise insulin infusion through high-frequency injection using a multi-nozzle array. At the same time, it feeds back the actual blood glucose data to the blood glucose monitoring and control device to form a closed-loop control.

[0010] Preferably, the blood glucose monitoring regulator includes:

[0011] The system comprises a flexible glucose sensor chip, a multi-channel potentiostat, a closed-loop control module, and a wireless data transmission chip. The sensor chip is attached to the subject's skin. The potentiostat outputs a voltage to trigger the extraction of interspecies fluid. After the fluid is extracted, the sensor chip outputs a current signal related to glucose oxidation, which is converted into glucose concentration by the blood glucose data processing module, enabling real-time interaction with the closed-loop control module.

[0012] Preferably, the non-invasive syringe comprises:

[0013] The system includes an array of injection nozzles, a drug reservoir, a pulsed high-pressure module, a piezoelectric ceramic plate, a pressure sensor, and a piston assembly. The piezoelectric ceramic plate undergoes radial deformation under the action of the pulsed high-pressure module, forming a high pressure in the pressure chamber that drives the piston assembly. This causes insulin in the drug reservoir to be injected subcutaneously through the nozzle array. The injection process features alternating or cyclic activation of multiple nozzle arrays, high-frequency injection, temperature compensation, pressure regulation, and a closed-loop feedback correction mechanism to achieve precise, safe, and continuous insulin infusion.

[0014] Preferably, the current output by the sensing chip With interstitial fluid glucose concentration Satisfies a linear relationship:

[0015]

[0016] in This is the sensor sensitivity coefficient. This is the zero-point offset.

[0017] Preferably, the multichannel potentiostat extracts interstitial fluid from the skin surface using electroosmosis, reverse ion migration, or micro-negative pressure assisted methods, and sets its working voltage and current to meet skin safety standards.

[0018] Preferably, the blood glucose data processing module converts the current signal into blood glucose concentration and inputs it into an LSTM model for blood glucose trend prediction. The prediction function is expressed as:

[0019]

[0020] in, Indicates past time window The LSTM provides a blood glucose sequence within a given timeframe, with a prediction window covering a future period, and features adaptive calibration and outlier detection capabilities.

[0021] Preferably, the dose decision unit is based on Calculate the additional dose using the following general method. :

[0022]

[0023] in, This is the dose coefficient. For reference blood glucose levels.

[0024] Preferably, the injection pressure adjustment module compensates for pressure based on skin temperature T, satisfying the formula:

[0025]

[0026] in The adjusted injection pressure, This refers to the skin surface temperature.

[0027] Preferably, the injection channel control module controls the alternating or cyclic activation of the six nozzle arrays to disperse the local injection load and improve the overall injection efficiency.

[0028] Preferably, the closed-loop feedback module is based on the predicted blood glucose level. Compared with actual blood glucose The difference is used to adjust the next injection dose, satisfying the formula:

[0029]

[0030] in This is a correction factor.

[0031] In summary, the present invention has the following main beneficial effects:

[0032] This invention integrates a flexible sensing chip, a potentiostat, an LSTM intelligent prediction module, and a piezoelectric needleless injection unit to construct a closed-loop non-invasive insulin detection and precise infusion system. It overcomes the problems of poor user compliance, delayed test results, inaccurate injection dosage control, and insufficient safety protection caused by reliance on blood sampling in existing technologies. This system can achieve non-invasive, highly sensitive real-time blood glucose monitoring, and significantly improve the accuracy and timeliness of insulin administration through trend prediction and individualized dosage decision-making.

[0033] This invention employs a multi-nozzle array piezoelectric needleless injection method during the injection process, combined with temperature compensation and voltage regulation and a closed-loop feedback correction mechanism, to effectively reduce the burden on local tissues and improve comfort and safety. It is also equipped with multiple safety protections and wireless data transmission functions to achieve remote monitoring and intelligent management, thereby significantly improving the convenience, accuracy and reliability of blood glucose management for diabetic patients. Attached Figure Description

[0034] Figure 1 This is a system flowchart of the present invention;

[0035] Figure 2 This is a schematic diagram of the blood glucose monitoring regulator structure of the present invention;

[0036] Figure 3 This is a schematic diagram of the non-invasive syringe structure of the present invention. Detailed Implementation

[0037] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are some embodiments of the present invention, but not all embodiments. Based on the described 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.

[0038] The following embodiments are used to illustrate the present invention, but should not be used to limit the scope of protection of the present invention. The conditions in the embodiments can be further adjusted according to specific conditions, and simple improvements to the method of the present invention under the premise of the concept of the present invention are all within the scope of protection claimed by the present invention.

[0039] Example 1: Scenario of rapid rise in postprandial blood glucose

[0040] refer to Figures 1-3 In the experimental simulation environment, a blood glucose monitoring and control device was fixed on a simulated skin model for testing. A glucose sensor chip integrated on a flexible substrate was connected to a multi-channel potentiostat, communicating in real-time with the control module via wireless data transmission. A 0.5 mL insulin reservoir was fixed via a magnetic interface and equipped with an RFID tag for drug type verification. Skin temperature was also monitored. The simulated temperature is 34°C, used for insulin absorption compensation. After the system starts, the control module performs self-checks on each unit, including the piston assembly, piezoelectric ceramic sheet, pressure sensor and nozzle array, to ensure that all components are in standby mode.

[0041] Under conditions simulating a rapid rise in postprandial blood glucose, the CGM module collects blood glucose current values. According to the formula:

[0042]

[0043] Where k = 0.075 μA / (mg / dL) and b = 1 μA, blood glucose concentration can be calculated.

[0044]

[0045] The blood glucose data processing module inputs the blood glucose sequence of the past 120 minutes into the LSTM model to predict the blood glucose trend for the next 30 minutes. The dosage decision module uses the formula:

[0046]

[0047] Calculate the required additional insulin dose .

[0048] The control module is based on skin temperature Adjust injection pressure It activates the piezoelectric ceramic sheet pulse high-voltage module, and the six nozzle arrays perform injection in a high-frequency alternating jet manner, with each nozzle injecting a single volume of [volume value missing]. The total amount reached The piston assembly propels insulin through the microchannel injection nozzle, precisely injecting it into the superficial to deep layers of the subcutaneous tissue. The pressure sensor monitors the injection pressure in real time, and the control module automatically adjusts it based on feedback to ensure that the injection pressure is within the set range, while reducing the burden on local tissues and pain.

[0049] After the injection is completed, the closed-loop feedback module continues to collect blood glucose current. Calculate the corresponding blood glucose concentration:

[0050]

[0051] The closed-loop feedback module calculates the difference between the predicted and actual blood glucose levels:

[0052]

[0053] Calculate the next injection dose correction value:

[0054]

[0055] System safety policies limit a single additional dose to no more than To prevent hypoglycemia or overdose, the system updates blood glucose data every 5 minutes and cycles through data acquisition, blood glucose prediction, dose calculation, pressure regulation, and alternating injection from multiple nozzles to keep blood glucose within a safe range.

[0056] This embodiment achieves continuous blood glucose monitoring and personalized insulin infusion through a flexible non-invasive sensing chip, a high-precision potentiostat, a multi-nozzle piezoelectric array, high-frequency injection, temperature compensation, and closed-loop feedback control. It fully solves the problems of invasiveness, hysteresis, localized burden concentration, and operational complexity of existing closed-loop pump and needle-free injection systems, demonstrating the reliability and effectiveness of the closed-loop non-invasive insulin detection and precise infusion system of this invention.

[0057] Example 2: Simulated Nighttime Blood Glucose Fluctuations

[0058] refer to Figures 1-3 In the experimental simulation environment, a blood glucose monitoring and control device was fixed on a simulated skin model for nighttime blood glucose fluctuation testing. A glucose sensor chip integrated on a flexible substrate was connected to a multi-channel potentiostat, communicating in real-time with the control module via wireless data transmission. A 0.5 mL insulin reservoir was fixed via a magnetic interface and equipped with an RFID tag for drug type verification. Simulated skin temperature was measured at night. The simulated temperature is 32°C, used for insulin absorption compensation. After the system starts, the control module performs self-checks on each unit, including the piston assembly, piezoelectric ceramic sheet, pressure sensor and nozzle array, to ensure that all components are in standby mode.

[0059] Under conditions of nocturnal blood glucose fluctuations, the CGM module collects blood glucose current values. According to the formula:

[0060]

[0061] Where k = 0.075 μA / (mg / dL) and b = 1 μA, blood glucose concentration can be calculated.

[0062]

[0063] The blood glucose data processing module inputs the blood glucose sequence of the past 120 minutes into the LSTM model to predict the blood glucose trend for the next 30 minutes. The dosage decision module uses the formula:

[0064]

[0065] Calculate the required nighttime insulin dose .

[0066] The control module is based on skin temperature Adjust injection pressure It activates the piezoelectric ceramic sheet pulse high-voltage module, and the six nozzle arrays perform injection in a high-frequency alternating jet manner, with each nozzle injecting a single volume of [volume value missing]. The total amount reached The piston assembly propels insulin through the microchannel injection nozzle, precisely injecting it into the superficial to deep layers of the subcutaneous tissue. A pressure sensor monitors the injection pressure in real time, and the control module dynamically adjusts it based on feedback to ensure stable pressure while reducing the burden on local tissues.

[0067] After the injection is completed, the closed-loop feedback module continues to collect blood glucose current. Calculate the corresponding blood glucose concentration:

[0068]

[0069] The closed-loop feedback module calculates the difference between the predicted and actual blood glucose levels:

[0070]

[0071] Calculate the next injection dose correction value:

[0072]

[0073] System safety policies limit a single additional dose to no more than It also adds nighttime hypoglycemia alarm and remote monitoring functions to prevent hypoglycemia or overdose. The system continuously updates blood glucose data at set time intervals and performs data collection, blood glucose prediction, dosage calculation, pressure adjustment and multi-nozzle alternating injection in a loop to achieve closed-loop management of blood glucose at night.

[0074] This embodiment utilizes a flexible non-invasive sensing chip, a high-precision potentiostat, a multi-nozzle piezoelectric array, high-frequency injection, temperature compensation, and closed-loop feedback control to achieve timely monitoring of nighttime blood glucose fluctuations and individualized insulin infusion. It effectively solves the problems of lagging, complex operation, and insufficient safety of existing closed-loop pump and needle-free injection systems in nighttime blood glucose management, and further verifies the reliability and intelligent management capabilities of the closed-loop non-invasive insulin detection and precise infusion system of this invention.

[0075] In summary, Examples 1 and 2, by simulating scenarios of rapid postprandial blood glucose rise and nocturnal blood glucose fluctuations, verified the effectiveness of the closed-loop non-invasive insulin monitoring and precise infusion system: the system can achieve non-invasive, highly sensitive real-time blood glucose monitoring, calculate individualized insulin dosage based on LSTM prediction of blood glucose trends, and achieve continuous, accurate, and safe insulin infusion through multi-nozzle high-frequency piezoelectric needleless injection, high-precision pressure regulation, and closed-loop feedback correction. It effectively solves the problems of invasiveness, lag, concentrated local burden, and complex operation of traditional closed-loop pumps and needleless injection systems, and improves the comfort, reliability, and intelligence level of blood glucose management for diabetic patients.

[0076] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that, unless otherwise defined, the technical or scientific terms used in this invention should be understood in the ordinary sense by those skilled in the art to which this invention pertains, and the terms "comprising" or "including" or similar terms used in this invention mean that the element or object preceding the word covers the element or object listed after the word and its equivalents.

[0077] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A closed-loop non-invasive insulin detection and precise infusion system, characterized in that, include: A blood glucose monitoring and regulation device is used to continuously acquire glucose concentration data in the subcutaneous tissue fluid of subjects and perform closed-loop blood glucose regulation. Non-invasive injectors are used to automatically administer insulin injections based on blood glucose monitoring data. The closed-loop control mechanism includes: a real-time blood glucose detection module, a temperature detection module, a blood glucose data processing module, a dose decision module, an injection pressure adjustment module, an injection channel control module, an insulin injection module, and a closed-loop feedback module. The closed-loop control mechanism dynamically calculates the injection dose and adjusts the injection pressure based on blood glucose concentration and temperature signals, and achieves precise insulin infusion through high-frequency injection using a multi-nozzle array. At the same time, it feeds back the actual blood glucose data to the blood glucose monitoring and control device to form a closed-loop control.

2. The closed-loop non-invasive insulin detection and precise infusion system according to claim 1, characterized in that, The blood glucose monitoring controller includes: The system comprises a flexible glucose sensor chip, a multi-channel potentiostat, a closed-loop control module, and a wireless data transmission chip. The sensor chip is attached to the subject's skin. The potentiostat outputs a voltage to trigger the extraction of interspecies fluid. After the fluid is extracted, the sensor chip outputs a current signal related to glucose oxidation, which is converted into glucose concentration by the blood glucose data processing module, enabling real-time interaction with the closed-loop control module.

3. The closed-loop non-invasive insulin detection and precise infusion system according to claim 1, characterized in that, The non-invasive syringe includes: The system includes an array of injection nozzles, a drug reservoir, a pulsed high-pressure module, a piezoelectric ceramic plate, a pressure sensor, and a piston assembly. The piezoelectric ceramic plate undergoes radial deformation under the action of the pulsed high-pressure module, forming a high pressure in the pressure chamber that drives the piston assembly. This causes insulin in the drug reservoir to be injected subcutaneously through the nozzle array. The injection process features alternating or cyclic activation of multiple nozzle arrays, high-frequency injection, temperature compensation, pressure regulation, and a closed-loop feedback correction mechanism to achieve precise, safe, and continuous insulin infusion.

4. The closed-loop non-invasive insulin detection and precise infusion system according to claim 1, characterized in that, The current output by the sensing chip With interstitial fluid glucose concentration Satisfies a linear relationship: in This is the sensor sensitivity coefficient. This is the zero-point offset.

5. The closed-loop non-invasive insulin detection and precise infusion system according to claim 1, characterized in that, The multichannel potentiostat extracts interstitial fluid from the skin surface using electroosmosis, reverse ion migration, or micro-negative pressure assisted methods, and sets its working voltage and current to meet skin safety standards.

6. The closed-loop non-invasive insulin detection and precise infusion system according to claim 1, characterized in that, The blood glucose data processing module converts the current signal into blood glucose concentration and inputs it into the LSTM model for blood glucose trend prediction. The prediction function is expressed as follows: in, Indicates past time window The LSTM provides a blood glucose sequence within a given timeframe, with a prediction window covering a future period, and features adaptive calibration and outlier detection capabilities.

7. The closed-loop non-invasive insulin detection and precise infusion system according to claim 1, characterized in that, The dose decision unit is based on Calculate the additional dose using the following general method. : in, This is the dose coefficient. For reference blood glucose levels.

8. The closed-loop non-invasive insulin detection and precise infusion system according to claim 1, characterized in that, The injection pressure adjustment module compensates for pressure based on skin temperature T, satisfying the formula: in The adjusted injection pressure, This refers to the skin surface temperature.

9. The closed-loop non-invasive insulin detection and precise infusion system according to claim 1, characterized in that, The injection channel control module controls the alternating or cyclic activation of the six nozzle arrays to disperse the local injection load and improve the overall injection efficiency.

10. The closed-loop non-invasive insulin detection and precise infusion system according to claim 1, characterized in that, The closed-loop feedback module is based on predicted blood glucose levels. Compared with actual blood glucose The difference is used to adjust the next injection dose, satisfying the formula: in This is a correction factor.

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