Intelligent pressure adjusting insole suitable for diabetic foot patient

Abstract

The invention relates to an intelligent pressure adjusting insole suitable for a diabetic foot patient, which comprises an intelligent insole structure, a pressure monitoring and gait analysis module, an intelligent fluid control module, a wireless data transmission module, an energy management and power supply system and a user interface and data management module, a pressure monitoring and gait analysis module, an intelligent fluid control module, a wireless data transmission module and an energy management and power supply system are integrated in the intelligent insole structure, and an insole of the intelligent insole structure is of a three-layer structure comprising an upper layer, a middle layer and a lower layer. The intelligent pressure adjusting insole suitable for the diabetic foot patient integrates the functions of high-precision pressure monitoring, gait analysis, intelligent fluid pressure adjustment and wireless data transmission, and aims at effectively preventing and relieving foot complications through intelligent means and improving the comfort and health management level of the patient.

Description

Technical Field

[0001] The invention relates to an intelligent insole, in particular to an intelligent pressure regulating insole for patients with diabetic foot. Background Art

[0002] Due to poor long-term blood sugar control, diabetic high-risk foot patients often suffer from neuropathy and vascular disease, which leads to decreased sensation in the feet and poor blood circulation. These factors make the patient's feet susceptible to continuous local high pressure, which in turn causes foot ulcers and infections, and even requires amputation in severe cases. Although traditional insoles have basic cushioning and support functions, their pressure distribution is usually static and cannot be adjusted dynamically according to the patient's gait, making it difficult to effectively prevent the occurrence of foot complications.

[0003] In recent years, smart insoles have been gradually applied to the field of foot health management, which can monitor the pressure of the sole of the foot in real time and provide data analysis. However, existing smart insoles generally have the following shortcomings:

[0004] (1) Low integration: Generally, the focus is on solving one or two of the following problems: battery life, data processing, sensor design, gait analysis, pressure monitoring, insole cooling or massage.

[0005] (2) Material selection: The vibration-damping materials are mainly PU, EVA, silicone, ORTHOLITE, high-density sponge, ordinary gel, memory foam, bamboo fiber, etc. These materials are usually selected from the perspective of vibration isolation rather than actively distributing stress.

[0006] (3) Degree of intelligence: The current smart insoles have a low degree of intelligence, mainly realizing intelligence from the perspective of monitoring. They are unable to actively use intelligent technology to help patients avoid or reduce the squeezing pressure on the affected area.

[0007] (4) Lack of personalized control: Existing insoles lack connectivity with the user’s smart devices and cannot dynamically adjust the pressure distribution in specific areas according to personal needs.

[0008] Therefore, there is an urgent need to develop a smart insole that integrates high-precision pressure monitoring, intelligent gait analysis, dynamic pressure distribution adjustment, wireless data transmission and personalized control functions to meet the special needs of diabetic high-risk foot patients and improve the level of foot health management.

[0009] Chinese patent CN113951607A discloses a method for designing diabetic foot prevention insoles based on multiple gait moments. The method needs to first extract and analyze the plantar pressure data of the diabetic population during the heel contact period, neutral period, and toe push-off period, and classify them according to the percentage, position, and shape of high pressure. Then, the insole decompression structure is designed for each type of abnormal high pressure area, and the foot-shoe insole finite element model of three gait moments is established and simulated, and then the parameters of the buffer structure are optimized. Finally, the insole is made using 3D printing technology and an effect verification experiment is performed. The insole made by this method is complex and cannot be intelligently controlled. The insole made by this method can be used to treat the patient's temporary disease state and has a certain effect, but diabetic foot is a disease that is extremely easy to recur. After recurrence, the affected area may change, causing the insole to be unable to continue to be used and need to be customized again, resulting in a large amount of patient expenses and difficulty in reducing the probability of recurrence.

[0010] Chinese patent CN113925258A discloses a protective insole with personalized decompression for patients with diabetic toe amputations. The method collects plantar pressure and replaces the unit, which can be specifically applied to patients with diabetic toe amputations, effectively reducing plantar pressure, preventing lesions from worsening, and improving gait stability. The patent sets a pluggable hexagonal plug in the high-pressure area of ​​the forefoot and hindfoot of the insole, and the effect of reducing plantar pressure is achieved by replacing the plug. Although this replacement method has increased replaceability compared to patent CN113951607A, it needs to be manually replaced after analyzing the gait pressure, and intelligent control cannot be achieved.

[0011] Chinese patent CN204971297U discloses a multifunctional intelligent insole, which mainly solves the adverse effects of improper walking and running postures on the body. Its composition includes some modules that can realize intelligence, including: an insole body, a pressure signal acquisition module, a chip, a power supply module, and a wireless transmission module. The force sensor of the insole is mainly distributed in the high-pressure area of ​​the sole, including the forefoot and the back of the foot. This patent mainly monitors the user's movement posture and warns the user of incorrect posture. In terms of the degree of intelligence, the insole has achieved preliminary intelligence, but it mainly plays a monitoring role and cannot be actively and directly controlled.

[0012] Chinese patent CN117413996A discloses a method, system and smart insole for relieving foot ulcers based on smart insoles. The smart insole is provided with an insole airbag filled with gas, which can avoid the sole from contacting the ulcer site, reduce the risk of deterioration of the ulcer site, reduce the pain caused by the sole being squeezed, and improve the patient's quality of life. The method mainly changes the pressure on the sole of the foot by adjusting the volume of gas in the airbag. The airbag is designed with a processor that can analyze the pressure and send instructions to reduce the pressure on the affected area. The method published in the patent mainly designs insoles by collecting the pressure on the sole of the foot and the ulcer area initially set. Due to the lack of visual operation, if the ulcer area changes, it is difficult to specify the corresponding part for pressure adjustment. It can only be adjusted according to the pressure provided by gait analysis, which will cause inaccurate control. Summary of the invention

[0013] The problem to be solved by the present invention is to provide an intelligent pressure-regulating insole suitable for patients with diabetic foot, which realizes high-precision pressure monitoring, real-time gait analysis, dynamic pressure distribution adjustment and personalized control by integrating a multi-layer structure, advanced intelligent algorithms and wireless communication technology, thereby effectively preventing foot complications in patients with high-risk diabetic foot and improving the comfort and health management level of the wearer.

[0014] To achieve the above-mentioned purpose, the technical solution of the present invention is: an intelligent pressure regulating insole suitable for patients with diabetic foot, comprising an intelligent insole structure, a pressure monitoring and gait analysis module, an intelligent fluid control module, a wireless data transmission module, an energy management and power supply system, a user interface and a data management module.

[0015] The intelligent insole structure integrates pressure monitoring and gait analysis module, intelligent fluid control module, wireless data transmission module, energy management and power supply system; the insole of the intelligent insole structure adopts a three-layer structure of upper layer, middle layer and lower layer;

[0016] Pressure monitoring and gait analysis module: Through the high-precision pressure sensor panel embedded in the insole, the plantar pressure distribution data is collected in real time. The collected data is pre-processed and gait analyzed through the microcontroller chip to identify high-pressure areas and gait abnormalities;

[0017] Intelligent fluid control module: It uses a microcontroller chip and intelligent fluid materials. The microcontroller chip generates a control signal based on the gait analysis results, outputs current through a flexible circuit board, and controls the fluidity of the intelligent fluid material. The intelligent fluid material adjusts the viscosity based on the current to achieve dynamic distribution of pressure and reduce the pressure in the high-pressure area.

[0018] Wireless data transmission module: built-in Bluetooth or Wi-Fi module to achieve wireless connection with smartphone applications;

[0019] Energy management and power supply system: used for piezoelectric energy harvesting and energy storage and management;

[0020] User interface and data management module: The smartphone is used to provide real-time data monitoring, including pressure distribution diagrams and gait analysis results. Users can set pressure adjustment parameters for different areas through the smartphone application, which automatically adjusts the fluidity of the smart fluid according to the settings to optimize the pressure distribution in specific areas. The application provides real-time monitoring, data analysis, health advice and early warning prompts, provides personalized health management advice and early warning prompts, supports historical data storage and analysis, and helps users and medical professionals assess their health status.

[0021] Furthermore, the upper layer of the insole: adopts flexible and comfortable memory materials, including memory foam and memory PU, to provide basic comfort and support; the middle layer of the insole: integrates intelligent fluid materials, which can adjust fluidity according to electrical signals to achieve dynamic pressure distribution; the lower layer of the insole: contains piezoelectric materials, pressure sensor panels, flexible circuit boards, microcontroller chips, wireless communication modules, power management modules, capacitors, charging controllers, batteries and wear-resistant material soles, which are used for energy collection, data processing, pressure regulation control and wireless data transmission.

[0022] Furthermore, the data processing module built into the microcontroller chip performs denoising, normalization and feature extraction on the raw data to ensure the accuracy and availability of the data.

[0023] Furthermore, the microcontroller chip uses an embedded artificial intelligence algorithm to analyze the preprocessed gait pressure data, extract key parameters, including cadence, stride length, and peak pressure, and use machine learning models and deep learning models to perform pattern recognition on gait data to detect gait abnormalities and high-pressure areas.

[0024] The microcontroller chip generates corresponding control signals according to the results of gait analysis, adjusts the fluidity of the intelligent fluid material, and realizes real-time pressure distribution optimization; feedback control and rule-based control strategies are adopted to ensure the stability and efficiency of pressure redistribution.

[0025] Furthermore, the microcontroller chip is connected to the wireless communication module through a standard interface, and signal shielding and antenna optimization are performed to ensure the stability and low interference of data transmission.

[0026] Furthermore, the integration of flexible circuit boards and smart fluid material layers in piezoelectric materials can ensure the high efficiency and stability of energy harvesting.

[0027] Furthermore, in the three-layer structure of the insole, the upper layer of memory material, the middle layer of smart fluid material and the lower layer of piezoelectric material are compounded by a hot pressing process to form a three-layer hot pressing composite structure.

[0028] Furthermore, polyurethane or silicone material is used in the lower layer of the insole to waterproof the circuit system.

[0029] Furthermore, piezoelectric energy harvesting is the process of converting mechanical energy into electrical energy during gait activities through the piezoelectric material of the lower layer to supply system operation; energy storage and management is the process of rectifying the collected electrical energy through the energy harvesting circuit and storing it in a small capacitor or lithium polymer battery to ensure stable power supply to the system, and adopt low power consumption and intelligent power consumption management strategies to extend the battery life of the insole.

[0030] The beneficial effects of the present invention are:

[0031] (1) High-precision pressure monitoring: By optimizing the sensor layout and advanced data processing algorithms, high-precision monitoring of plantar pressure can be achieved, accurately capturing pressure changes in different areas.

[0032] (2) Real-time gait analysis: Integrated intelligent algorithms can analyze gait data in real time, identify gait abnormalities, and provide timely health management recommendations.

[0033] (3) Dynamic pressure distribution regulation: Intelligent fluid materials are combined with microcontroller chips to achieve dynamic pressure distribution regulation, reduce pressure in high-pressure areas, and prevent foot ulcers.

[0034] (4) Efficient energy management: The piezoelectric material is used for self-powered and low-power design to extend the battery life of the insole and improve its ease of use.

[0035] (5) Comfort and durability: The three-layer structure design and high-quality material selection provide a comfortable wearing experience and a long service life.

[0036] (6) Comprehensive health management: Through smartphone applications, real-time monitoring, recording and analysis of data can be achieved to help users and medical professionals comprehensively manage foot health and reduce the risk of complications.

[0037] (7) Waterproof and durable design: Waterproof packaging technology and durable materials are used to ensure the stability and service life of the insole in various environments, adapting to the daily life needs of patients with high-risk diabetic foot.

[0038] (8) Personalized control: Through wireless connection and mobile phone applications, users can set pressure adjustment parameters for different areas according to their own needs, achieve personalized pressure distribution optimization, and further improve the accuracy and effectiveness of foot health management. BRIEF DESCRIPTION OF THE DRAWINGS

[0039] Figure 1 It is a schematic diagram of the overall structure of the intelligent pressure regulating insole of the present invention;

[0040] Figure 2This is a schematic diagram of the structure of the lower layer of the intelligent pressure regulating insole of the present invention;

[0041] Figure 3 It is a schematic diagram of the structure of the flexible circuit board module of the present invention;

[0042] Figure 4 The data processing flow chart of the present invention. DETAILED DESCRIPTION

[0043] The present invention will be further described below in conjunction with the accompanying drawings and embodiments.

[0044] like Figures 1 to 4 As shown, the intelligent pressure regulating insole suitable for diabetic foot patients of the present invention comprises:

[0045] (1) Smart insole structure design

[0046] The insole adopts a three-layer structure, including:

[0047] a) Upper layer 1: High elastic memory foam or memory PU, about 2mm-3mm thick, provides sufficient cushioning and comfort. The material must have good air permeability and moisture absorption to ensure that the feet are dry and comfortable.

[0048] b) Middle layer 2: It is a smart fluid material, which is a smart fluid that can adjust viscosity in response to electrical signals, such as electrorheological gel. It has a thickness of about 2-3 mm and is distributed in the key pressure-bearing areas of the insole.

[0049] c) Lower layer 3: includes piezoelectric material 3-1, pressure sensor panel 3-2, flexible circuit board 3-3, microcontroller chip, wireless communication module (such as Bluetooth or Wi-Fi unit), power management module, capacitor, charging controller, battery and wear-resistant material sole 3-4, responsible for energy collection, data processing, pressure regulation control and wireless data transmission. The lower circuit system uses flexible piezoelectric materials such as polyvinylidene fluoride (PVDF) to effectively convert gait pressure into electrical energy. The pressure sensor panel is arranged below the piezoelectric material, and the flexible circuit board is arranged below the pressure sensor panel. The flexible circuit board also includes a microcontroller chip, a wireless communication module (such as Bluetooth or Wi-Fi unit), a power management module, capacitor, charging controller and battery. The bottom layer is wear-resistant material, which mainly has the functions of wear resistance and anti-skid. The integrated small lithium polymer battery (10) is used to store the electrical energy generated by the piezoelectric material to ensure the continuous power supply of the system.

[0050] (2) Function Implementation

[0051] a) Pressure monitoring and gait analysis: The pressure sensor panel collects pressure data from different areas of the sole of the foot in real time. The pressure data is transmitted to the microcontroller chip through the flexible circuit board for data preprocessing and gait analysis to identify high-pressure areas and gait abnormalities.

[0052] b) Intelligent fluid control: The microcontroller chip generates a control signal based on the gait analysis results, outputs current through the flexible circuit board, and controls the fluidity of the intelligent fluid material. The intelligent fluid material adjusts the viscosity according to the current, realizes the dynamic distribution of pressure, and reduces the pressure in the high-pressure area.

[0053] c) Wireless data transmission and personalized control: The wireless communication module has a built-in Bluetooth or Wi-Fi unit, which is connected to the smartphone application wirelessly. Users can set the pressure adjustment parameters for different areas through the mobile phone application, such as setting the upper limit of pressure in a specific area. The system automatically adjusts the fluidity of the smart fluid according to the settings to reduce the pressure in the area. The mobile phone application also provides real-time data monitoring, gait analysis results display, health advice push and abnormal warning functions to assist users in personalized foot health management.

[0054] d) Power storage: The pressure is converted into a current signal through a microcontroller chip, and the battery charging is monitored and managed through a capacitor management module to ensure safety and efficiency. The capacitor and charging controller are then used to achieve a smooth charging process.

[0055] (3) Data processing

[0056] a) Data acquisition and preprocessing: The pressure sensor collects data in real time and transmits it to the microcontroller chip through the flexible circuit board. The built-in data processing module of the microcontroller chip performs denoising, normalization and feature extraction on the raw data to ensure the accuracy and availability of the data.

[0057] b) Gait analysis algorithm: The microcontroller chip uses an embedded artificial intelligence algorithm to analyze the pre-processed gait pressure data and extract key parameters (such as cadence, stride, peak pressure, etc.). Machine learning models (such as support vector machines, random forests) and deep learning models (such as convolutional neural networks, recurrent neural networks) are used to perform pattern recognition on gait data to detect gait abnormalities and high-pressure areas.

[0058] c) Pressure distribution control algorithm: According to the gait analysis results, the microcontroller chip generates corresponding control signals to adjust the fluidity of the smart fluid material and achieve real-time pressure distribution optimization. Feedback control (such as PID control) and rule-based control strategies are used to ensure the stability and efficiency of pressure redistribution.

[0059] d) Wireless data transmission and mobile phone application interaction: The analyzed data is transmitted to the smartphone application through the wireless communication module. The mobile phone application receives and displays real-time monitoring data, including pressure distribution diagrams, gait analysis results, etc. Users set pressure adjustment parameters for different areas through the application interface. The application sends instructions to the insole system. The microcontroller chip adjusts the fluidity of the smart fluid according to the instructions to reduce the pressure in specific areas. The application also provides historical data storage and analysis functions to help users and medical professionals assess health status and develop personalized health management plans.

[0060] (4) Manufacturing process

[0061] a) Multi-layer hot pressing composite: The upper layer of memory material, the middle layer of smart fluid material and the lower layer of piezoelectric material are composited by hot pressing process to ensure the close bonding and stability between the layers.

[0062] b) Waterproof packaging treatment: The lower circuit system adopts waterproof packaging technology, such as using polyurethane or silicone materials, to ensure the stable operation of the circuit in a humid environment and prevent liquid from entering and damaging electronic components.

[0063] c) Flexible circuit welding: Flexible circuit board technology is used to perform precise welding of tiny components to ensure the flexibility and durability of the circuit and adapt to the dynamic deformation of the insole.

[0064] d) Piezoelectric material integration: Through the lamination technology of piezoelectric materials, they are effectively integrated with the flexible circuit board and the smart fluid material layer to ensure the high efficiency and stability of energy harvesting.

[0065] e) Wireless module integration: The wireless communication module is connected to the microcontroller chip through a standard interface, and signal shielding and antenna optimization are performed to ensure the stability and low interference of data transmission.

Claims

1. An intelligent pressure regulating insole suitable for patients with diabetic foot, characterized in that: It includes intelligent insole structure, pressure monitoring and gait analysis module, intelligent fluid control module, wireless data transmission module, energy management and power supply system, user interface and data management module, among which: The intelligent insole structure integrates pressure monitoring and gait analysis module, intelligent fluid control module, wireless data transmission module, energy management and power supply system; the insole of the intelligent insole structure adopts a three-layer structure of upper layer, middle layer and lower layer; Pressure monitoring and gait analysis module: Through the high-precision pressure sensor panel embedded in the insole, the plantar pressure distribution data is collected in real time. The collected data is pre-processed and gait analyzed through the microcontroller chip to identify high-pressure areas and gait abnormalities; Intelligent fluid control module: It uses a microcontroller chip and intelligent fluid materials. The microcontroller chip generates a control signal based on the gait analysis results, outputs current through a flexible circuit board, and controls the fluidity of the intelligent fluid material. The intelligent fluid material adjusts the viscosity based on the current to achieve dynamic distribution of pressure and reduce the pressure in the high-pressure area. Wireless data transmission module: built-in Bluetooth or Wi-Fi module to achieve wireless connection with smartphone applications; Energy management and power supply system: used for piezoelectric energy harvesting and energy storage and management; User interface and data management module: The smartphone is used to provide real-time data monitoring, including pressure distribution diagrams and gait analysis results. Users can set pressure adjustment parameters for different areas through the smartphone application, which automatically adjusts the fluidity of the smart fluid according to the settings to optimize the pressure distribution in specific areas. The application provides real-time monitoring, data analysis, health advice and early warning prompts, provides personalized health management advice and early warning prompts, supports historical data storage and analysis, and helps users and medical professionals assess their health status.

2. The intelligent pressure regulating insole for diabetic foot patients according to claim 1, characterized in that: The upper layer of the insole: uses flexible and comfortable memory materials, including memory foam and memory PU, to provide basic comfort and support; the middle layer of the insole: integrates intelligent fluid materials, which can adjust fluidity according to electrical signals and achieve dynamic pressure distribution; the lower layer of the insole: contains piezoelectric materials, pressure sensor panels, flexible circuit boards, microcontroller chips, wireless communication modules, power management modules, capacitors, charging controllers, batteries and wear-resistant material soles, which are used for energy collection, data processing, pressure regulation control and wireless data transmission.

3. The intelligent pressure regulating insole for diabetic foot patients according to claim 2, characterized in that: The data processing module built into the microcontroller chip performs denoising, normalization and feature extraction on the raw data to ensure the accuracy and availability of the data.

4. The intelligent pressure regulating insole for diabetic foot patients according to claim 2, characterized in that: The microcontroller chip uses an embedded artificial intelligence algorithm to analyze the pre-processed gait pressure data and extract key parameters, including cadence, stride length, and peak pressure. It uses machine learning models and deep learning models to perform pattern recognition on gait data and detect gait abnormalities and high-pressure areas.

5. The intelligent pressure regulating insole for diabetic foot patients according to claim 2, characterized in that: The microcontroller chip generates corresponding control signals according to the results of gait analysis, adjusts the fluidity of the intelligent fluid material, and realizes real-time pressure distribution optimization; feedback control and rule-based control strategies are adopted to ensure the stability and efficiency of pressure redistribution.

6. The intelligent pressure regulating insole for diabetic foot patients according to claim 2, characterized in that: The microcontroller chip is connected to the wireless communication module through a standard interface, and signal shielding and antenna optimization are performed to ensure the stability and low interference of data transmission.

7. The intelligent pressure regulating insole for diabetic foot patients according to claim 2, characterized in that: Integrating flexible circuit boards and smart fluid material layers into piezoelectric materials can ensure the high efficiency and stability of energy harvesting.

8. The intelligent pressure regulating insole for diabetic foot patients according to claim 2, characterized in that: In the three-layer structure of the insole, the upper layer of memory material, the middle layer of smart fluid material and the lower layer of piezoelectric material are compounded by a hot pressing process to form a three-layer hot pressing composite structure.

9. The intelligent pressure regulating insole for diabetic foot patients according to claim 2, characterized in that: The lower layer of the insole uses polyurethane or silicone material to waterproof the circuit system.

10. The intelligent pressure regulating insole for diabetic foot patients according to claim 1, characterized in that: Piezoelectric energy harvesting is the process of converting mechanical energy into electrical energy during gait activities through the lower layer of piezoelectric materials to supply system operation; energy storage and management is the process of rectifying the collected electrical energy through the energy harvesting circuit and storing it in a small capacitor or lithium polymer battery to ensure stable power supply to the system, and adopt low power consumption and intelligent power consumption management strategies to extend the battery life of the insole.

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