Diabetic foot biological pressure feedback adjusting device and pressure point identification method

Abstract

The invention discloses a diabetic foot biological pressure feedback adjusting device and a pressure point identification method.The pressure adjusting method comprises the following steps that a foot intelligent wearable device is worn on a foot, and base line pressure signals of all pressure measuring areas and actual plantar pressure signals are collected; according to a preset sensor calibration coefficient, the actual plantar pressure signals of all the pressure measurement areas are converted into area pressure values, and pressure intensity values of all the pressure measurement areas are obtained through calculation in combination with pre-obtained contact areas of all the pressure measurement areas; for a pressure measurement area corresponding to the diseased area of the diabetic high-risk foot, based on the pressure intensity value of the pressure measurement area, calculating the actual emission reduction gas amount required by the pressure measurement area for pressure reduction; the opening degree and deflation time of a deflation electromagnetic valve corresponding to the pressure measurement area are calculated on the basis of the actual emission reduction gas amount, and the foot intelligent wearable device conducts pressure reduction adjustment on the abnormal pressure measurement area on the basis of opening degree adjustment and deflation time.

Description

Technical Field

[0001] The present invention relates to the technical field of diabetic foot, and in particular to a diabetic foot biological pressure feedback regulation device and a pressure point recognition method. Background Art

[0002] As a severe complication in the late stage of diabetes, the pathological mechanism of diabetic foot stems from the synergistic effect of multiple factors: peripheral neuropathy caused by long-term hyperglycemia leads to the loss of protective sensation in the foot, microvascular lesions result in insufficient tissue perfusion, and the distortion of plantar pressure distribution caused by abnormal biomechanics. These three factors together form a vicious cycle of ulcer formation. During walking, due to proprioceptive disorders, patients with diabetic foot make compensatory gait adjustments, causing the peak vertical stress at key anatomical sites such as the metatarsal heads of the forefoot and the arch transition area to exceed the normal value by 2-3 times. The epidermal shear force in the abnormal high-pressure area can reach 4.6 times that of healthy people, ultimately leading to ischemic necrosis of the subcutaneous tissue and the formation of chronic wounds that are difficult to heal.

[0003] The current pressure management means for diabetic foot have obvious deficiencies. Traditional static support insoles or pressure dispersion devices are difficult to dynamically adjust according to the real-time plantar pressure distribution. It is difficult to significantly reduce the downward pressure load in the diseased area while ensuring normal pressure in other areas, and it cannot provide a pressure-free or low-pressure rehabilitation environment for the diseased area of diabetic foot, especially the plantar ulcer surface. Therefore, there is an urgent need for a technical solution that can achieve real-time pressure monitoring, dynamic calculation, and precise adjustment to relieve the problem of ulcer healing caused by abnormal pressure in diabetic foot patients. Summary of the Invention

[0004] Aiming at the above-mentioned prior art, the present invention provides a diabetic foot biological pressure feedback regulation device and a pressure point recognition method, mainly solving the technical problems existing in the above background art.

[0005] To achieve the above object, the technical solution of the embodiment of the present invention is realized as follows: In the first aspect of the present invention, a diabetic foot biological pressure feedback regulation device is disclosed. The pressure feedback regulation device includes a foot intelligent wearable device and an insole disposed in the foot intelligent wearable device. The insole is successively composed of a contact layer, a pressure reduction layer, and a protection layer from top to bottom. In the pressure reduction layer, a plurality of independent pressure measurement areas are divided. An airbag is correspondingly disposed in each pressure measurement area. An air release solenoid valve is provided on all airbags. One of all the airbags is designated as the main airbag, and the rest are auxiliary airbags. The main airbag is connected to each auxiliary airbag through an air supply channel. A first air supply solenoid valve is provided on the main airbag and is connected to an air pump. A second air supply solenoid valve is provided on the air supply channel. A main control chip and a separate pressure sensing unit are provided between the airbag in each pressure measurement area and the protection layer. The pressure sensing unit, the first air supply solenoid valve, the second air supply solenoid valve, and the main control chip are electrically connected.

[0006] Optionally, the pressure sensing unit includes a distributed pressure sensor array arranged on the bottom surface of the decompression layer.

[0007] A second aspect of the present invention discloses a method for identifying diabetic foot pressure points. The adjustment method is implemented based on a pressure feedback adjustment device, and the method includes the following steps:

[0008] Attach and fix the foot intelligent wearable device to the sole of the foot. The foot intelligent wearable device has a plurality of pressure measurement areas corresponding one by one to different partitions of the sole of the diabetic foot, and collect the baseline pressure signals and the actual pressure signals of the sole of the foot in each pressure measurement area;

[0009] According to the preset sensor calibration coefficient, convert the actual pressure signals of the sole of the foot in each pressure measurement area into regional pressure values, and combine the contact areas of each pressure measurement area obtained in advance to calculate the pressure values of each pressure measurement area;

[0010] By comparing the pressure values of each pressure measurement area with the safety thresholds of the corresponding partitions, identify the diseased areas and non-diseased areas of diabetic high-risk feet in each pressure measurement area;

[0011] For the pressure measurement area corresponding to the diseased area of the diabetic high-risk foot, based on the pressure value of the pressure measurement area, calculate the actual exhaust volume required for decompression of the pressure measurement area;

[0012] Based on the actual exhaust volume, calculate the opening degree and the deflation time of the deflation solenoid valve corresponding to the pressure measurement area. The foot intelligent wearable device performs decompression adjustment on the abnormal pressure measurement area based on the opening degree adjustment and the deflation time.

[0013] Optionally, the pressure measurement areas include the medial area of the first metatarsal bone, the middle area of the second metatarsal bone, the lateral area of the third metatarsal bone, the medial area of the anterior foot arch, the lateral area of the anterior foot arch, the medial area of the posterior foot arch, the lateral area of the posterior foot arch, and the heel area. Among them, the medial area of the first metatarsal bone corresponds to the area under the root of the big toe, the middle area of the second metatarsal bone corresponds to the area under the roots of the second and third toes, and the lateral area of the third metatarsal bone corresponds to the area under the roots of the fourth and fifth toes.

[0014] Optionally, the step of converting the original pressure signals of each pressure measurement area into regional pressure values according to the preset sensor calibration coefficient includes: for the multiple pressure sensors deployed in each pressure measurement area, respectively apply the corresponding sensor calibration coefficient to convert the original voltage signal into a pressure value; perform weighted averaging on the output values of the multiple pressure sensors in the same pressure measurement area to obtain the final pressure value of the area, where the weight coefficient is pre-calibrated based on the position distribution and sensitivity characteristics of each sensor in the area.

[0015] Optionally, the pre-acquired contact area of each pressure measurement area is obtained in the following manner: when the user uses it for the first time, the pressure distribution is scanned in a static standing posture to segment and calculate the initial contact area of each pressure measurement area; during dynamic walking, the contact area of each pressure measurement area is corrected in real time based on the pressure distribution data of multiple consecutive gait cycles, wherein the correction coefficient is dynamically adjusted based on the gait phase recognition result.

[0016] Optionally, the calculating of the actual reduced exhaust volume required for reducing the pressure in the pressure measurement area specifically includes:

[0017] The theoretical exhaust reduction Q is calculated based on the following formula LL :

[0018]

[0019] Obtain the elastic correction coefficient C through the stress-strain characteristic curve of the airbag material e , based on the correction coefficient, the actual emission reduction Q is obtained SJ :Q SJ =Q LL *C e ;

[0020] Among them, V is the current volume of the airbag, P c is the current airbag pressure, P s is the safety pressure threshold, P atm is standard atmospheric pressure.

[0021] Optionally, calculate the current airbag pressure, including:

[0022] Convert the baseline pressure signal of each pressure measurement area into a baseline pressure value according to a preset sensor calibration coefficient;

[0023] Combining the dynamic correction factor, the contact area of each pressure measurement area, and the baseline pressure value, the current airbag pressure value is calculated using the following formula:

[0024]

[0025] Among them, F QY is the regional pressure value, F JX is the baseline pressure value, A eff is the contact area between the sole of the foot and the foot smart wearable device, γ is the temperature compensation coefficient, T n is the set ambient temperature, T0 is the reference calibration temperature, C creep is the creep coefficient of the material.

[0026] Optionally, based on the actual exhaust gas volume reduction, calculate the opening degree and the exhaust time of the exhaust solenoid valve corresponding to the pressure measurement area, specifically including:

[0027] Establish an objective function aiming to obtain the optimal time cost and equipment loss, and set pressure constraints and engineering constraints. The objective function is:

[0028]

[0029] Wherein, is the time weight coefficient, τ is the equipment loss parameter, k opt is the optimal efficiency opening degree;

[0030] Encode the exhaust time T and the opening degree parameter k as a real vector [T, k], and use the improved NSGA-II algorithm to gradually solve for the exhaust time T and the opening degree parameter k, and finally find the optimal solution for the exhaust time T and the opening degree parameter k.

[0031] The beneficial effects of the present invention are as follows: For the pressure measurement area corresponding to the onset area of diabetic high-risk foot, by calculating the actual exhaust gas volume reduction required for decompression in this pressure measurement area, that is, the volume of gas to be released, based on the actual exhaust gas volume reduction, calculate the opening degree and the exhaust time of the corresponding exhaust solenoid valve. The opening degree reflects the valve flow capacity, and the exhaust time reflects the duration of the decompression demand, and drive the solenoid valve to act according to the calculated parameters. By adjusting the opening degree and controlling the exhaust time, decompress the airbag in the pressure measurement area corresponding to the onset area of diabetic high-risk foot, so that the pressure in the pressure measurement area corresponding to the onset area of diabetic high-risk foot is reduced, while the pressure in other places remains unchanged. In this way, the downward pressure borne by the onset area of diabetic high-risk foot can be greatly reduced, providing a pressure-free or low-pressure rehabilitation environment for the plantar ulcer surface, thereby promoting the rehabilitation of the onset area of diabetic high-risk foot, especially the plantar ulcer surface. Description of the Drawings

[0032] Figure 1 is a schematic structural diagram of the insole in the embodiment of the present application;

[0033] Figure 2 is a schematic placement diagram of the main control chip and the pressure sensing unit in the embodiment of the present application;

[0034] Figure 3 is a schematic connection diagram of the signal module of the pressure feedback adjustment device in the embodiment of the present application;

[0035] Figure 4 is a side view of the insole in the embodiment of the present application

[0036] Figure 5Schematic flow chart of the pressure regulation method for diabetic foot in the embodiments of this application;

[0037] Explanation of the reference numerals in the attached drawings:

[0038] 1. Insole; 2. Contact layer; 3. Decompression layer; 4. Protective layer; 5. Airbag; 6. Air release solenoid valve; 7. First air supply solenoid valve; 8. Second air supply solenoid valve; 9. First main air supply channel; 10. Second main air supply channel; 11. Air supply sub-channel; 12. Main control chip; 13. Pressure sensing unit; 14. Air pump. Detailed implementation manners

[0039] The technical solutions of the present invention will be further described in detail below with reference to the drawings in the specification and specific embodiments. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the technical field to which the present invention belongs. The terms used in the specification of the present invention herein are only for the purpose of describing specific embodiments, and are not intended to limit the present invention. In the following description, the expression "some embodiments" describes a subset of all possible embodiments, but it should be understood that "some embodiments" can be the same subset or different subsets of all possible embodiments, and can be combined with each other without conflict.

[0040] In the following description, a large number of specific details are given to provide a more thorough understanding of the present invention. However, it is obvious to those skilled in the art that the present invention can be implemented without one or more of these details. In other examples, in order to avoid confusion with the present invention, some well-known technical features in the art are not described.

[0041] It should be understood that the present invention can be implemented in different forms and should not be construed as limited to the embodiments presented herein. On the contrary, providing these embodiments will make the disclosure thorough and complete, and will fully convey the scope of the present invention to those skilled in the art. And the purpose of the terms used herein is only to describe specific embodiments and is not a limitation of the present invention. When used herein, the singular forms "a", "an" and "the" are also intended to include the plural forms unless the context clearly indicates otherwise. It should also be understood that the terms "comprising" and / or "including", when used in this specification, specify the presence of the described features, integers, steps, operations, elements and / or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components and / or groups. When used herein, the term "and / or" includes any and all combinations of the related listed items.

[0042] It should be noted that when an element is referred to as "fixed to" another element, it can be directly on the other element or there may be an intermediate element. When an element is considered to be "connected to" another element, it can be directly connected to the other element or there may be an intermediate element at the same time. The terms "vertical", "horizontal", "inner", "outer", "left", "right" and similar expressions used herein are for illustrative purposes only and do not represent the only implementation.

[0043] To thoroughly understand the present invention, detailed structures will be presented in the following description to illustrate the technical solutions proposed by the present invention. The optional embodiments of the present invention are described in detail below. However, in addition to these detailed descriptions, the present invention may also have other implementations.

[0044] Please refer to the attached Figures 1 to 4 In the first aspect of the present invention, a diabetic foot bio-pressure feedback regulation device is disclosed, including a shoe body and an insole 1 disposed in the shoe body. The insole 1 is sequentially composed of a contact layer 2, a decompression layer 3, and a protection layer 4 from top to bottom. A plurality of independent pressure measurement areas are defined in the decompression layer 3, and an airbag 5 is correspondingly disposed in each pressure measurement area. An air release solenoid valve is provided on all the airbags 5. One of the airbags 5 is designated as the main airbag 5, and the rest are auxiliary airbags 5. The main airbag 5 is connected to each auxiliary airbag 5 through an air supply channel. A first air supply solenoid valve 7 is provided on the main airbag 5 and is connected to an air pump 14. A second air supply solenoid valve 8 is provided on the air supply channel. A main control chip 12 and a separate pressure sensing unit 13 are provided between the airbag 5 in each pressure measurement area and the protection layer 4. The pressure sensing unit 13, the first air supply solenoid valve 7, and the second air supply solenoid valve 8 are all electrically connected to the main control chip 12.

[0045] Specifically, a diabetic foot bio-pressure feedback regulation device disclosed in this embodiment is applied to the plantar pressure regulation of patients at high risk of diabetes. It can achieve dynamic adjustment of the pressure on specific areas of the plantar surface. By dividing the decompression layer 3 into multiple independent pressure measurement areas, an airbag 5 is correspondingly arranged in each area, and each airbag 5 is equipped with an air release solenoid valve 6. After a patient at high risk of diabetes puts the foot into the shoe body, the contact layer 2 of the insole 1 fits the plantar surface. The main control chip 12 activates the distributed sensor array of the pressure sensing unit 13 and collects 30-second baseline pressure data in the state where the airbag 5 is not inflated. After collecting the 30-second baseline pressure data, an external air pump injects gas through the first gas transmission solenoid valve 7 of the main airbag 5. The main airbag 5 does not store gas and only serves as a transfer hub. The main control chip 12 sequentially opens the second gas transmission solenoid valves 8 on the gas transmission sub-channel 11 in a preset order, and the gas is directly transported to the target secondary airbag 5 through the gas transmission channel. When the airbag 5 in the target area expands, the pressure sensing unit 13 in this area real-time obtains the pressure value and feeds it back to the main control chip 12. If the pressure value reaches the safety threshold of the partition, the main control chip 12 closes the second gas transmission solenoid valve 8 corresponding to this pressure measurement area. According to this process, until all the main airbags 5 and secondary airbags 5 are filled with the rated pressure gas. Through sequential inflation of partitions and real-time pressure monitoring, precise construction of the pressure of the airbags 5 in each area is achieved.

[0046] Among them, the first main gas transmission channel 9 and the second main gas transmission channel 10 are respectively arranged in parallel along the left and right sides of the decompression layer 3, forming a symmetric gas transmission network. The first main gas transmission channel 9 and the second main gas transmission channel 10 are respectively connected to the airbags 5 in the corresponding pressure measurement areas through a number of gas transmission sub-channels 11. The second gas transmission solenoid valve 8 is integrated at the port of the gas transmission sub-channel 11 close to the airbag 5 and is controlled by the electrical signal of the main control chip 12. The gas path of each sub-channel can be independently opened or closed, making the gas transmission path short and efficient. It not only meets the demand for simultaneous gas supply in multiple areas, but also can independently adjust the gas flow in a single area through precise control of the solenoid valve, avoiding pressure interference between areas. The symmetric setting of the main channels on both sides also helps to balance the overall force on the insole 1 and improve the stability of the device during the inflation process.

[0047] After inflation is completed and the patient is wearing it normally, when the insole is in use, the actual plantar pressure signals of each pressure measurement area are collected in real time by the pressure sensing unit 13, and these signals are transmitted to the main control chip 12 through the wires in the protective layer 4. After receiving the signals, the main control chip 12 converts the actual plantar pressure signals of each pressure measurement area into regional pressure values according to the preset sensor calibration coefficients, and then combines the contact areas of each pressure measurement area obtained in advance to calculate the pressure values of each pressure measurement area. By comparing the pressure values of each pressure measurement area with the safety thresholds of the corresponding partitions, the diseased areas and non-diseased areas of diabetic high-risk feet in each pressure measurement area are identified. For the pressure measurement areas corresponding to the diseased areas of diabetic high-risk feet, especially the pressure measurement areas corresponding to the plantar ulcer surfaces, based on the pressure values of the pressure measurement areas, the actual amount of gas to be reduced and exhausted for decompression in the pressure measurement areas is calculated, that is, the volume of gas to be released. Based on the actual amount of gas to be reduced and exhausted, the main control chip 12 calculates the opening degree and deflation time of the corresponding deflation solenoid valve 6, and controls the corresponding deflation solenoid valve 6 to act according to the calculated opening degree and deflation time, so as to adjust the pressure of the airbag 5 in the abnormal pressure measurement area, so that the pressure in the pressure measurement area corresponding to the diseased area of diabetic high-risk feet is reduced, while the pressure in other places remains unchanged. In this way, the downward pressure borne by the diseased area of diabetic high-risk feet can be greatly reduced, providing a pressure-free or low-pressure rehabilitation environment for the plantar ulcer surface, thereby promoting the rehabilitation of the diseased area of diabetic high-risk feet, especially the plantar ulcer surface.

[0048] Further, the decompression layer 3 is divided into multiple independent pressure measurement areas corresponding one by one to different partitions of the diabetic foot sole, that is, the pressure measurement areas include the medial area of the first metatarsal bone, the middle area of the second metatarsal bone, the lateral area of the third metatarsal bone, the medial area of the anterior foot arch, the lateral area of the anterior foot arch, the medial area of the posterior foot arch, the lateral area of the posterior foot arch, and the heel area. Among them, the medial area of the first metatarsal bone corresponds to the area under the root of the big toe, the middle area of the second metatarsal bone corresponds to the area under the roots of the second and third toes, and the lateral area of the third metatarsal bone corresponds to the area under the roots of the fourth and fifth toes. Airbags 5 are provided below the above pressure measurement areas, and the airbag 5 in the heel area is used as the main airbag 5, and the other airbags 5 are used as auxiliary airbags 5.

[0049] It should be noted that the setting of the safety threshold of the corresponding partition is obtained based on the safety pressure threshold of diabetic high-risk feet. In some embodiments, the diabetic high-risk foot safety threshold is generated according to the user's body characteristic parameters and medical diagnosis data to form a personalized diabetic high-risk foot safety threshold.

[0050] For example, when forming a personalized safety threshold for high-risk diabetic feet, first collect the three-dimensional morphological data of the patient's foot. Obtain 12 biomechanical parameters such as the height of the foot arch, the inclination angle of the calcaneus, and the morphological arrangement of the metatarsal bones through laser scanning, construct a digital foot model, and divide it into eight anatomical pressure measurement areas. The body mass index and body fat percentage data are input into the biomechanical model after standardization processing to calculate the basic load-bearing ratio of each area. For example, for a patient with a body weight exceeding 90 kg, the reference pressure value in the heel area needs to be increased by 12%. The medical diagnosis data includes glycated hemoglobin level, vibration perception threshold, ankle-brachial index, and ulcer history. Among them, the vibration perception test is implemented and graded quantitatively at five anatomical points using a 128 Hz tuning fork. When there is a grade 2 perception disorder at more than three test points, the system automatically triggers a pressure threshold down-regulation mechanism. For patients with an ankle-brachial index lower than 0.9, the algorithm implements a gradient attenuation of the pressure value in the foot arch area according to the degree of vascular occlusion, with an 8% pressure reduction corresponding to each 0.1 decrease in the index. The diabetes duration data affects the safety threshold through non-linear conversion. For patients with a diabetes duration exceeding 10 years, an enhanced protection mode is enabled in the forefoot area, and the threshold in this area is set to 75% of the reference value. The information on the history of foot ulcers is mapped to the risk coefficient matrix of the corresponding anatomical area. For patients who have had ulcers on the metatarsal head in the past, the pressure threshold in this area is reduced by 20% and a 15% safety redundancy is superimposed. The core calculation formula combines the biomechanical correction factor and the clinical risk coefficient, and uses a weighted geometric mean algorithm to generate the final threshold for different pressure measurement areas.

[0051] Further, a plurality of pressure sensing units 13 are provided between the airbag 5 and the protective layer 4 in each pressure measurement area, and each of the pressure sensing units 13 includes a distributed pressure sensor array.

[0052] The following is an explanation in combination with the actual process:

[0053] Suppose a patient with high-risk diabetic foot has three ulcer surfaces on the sole, namely the lateral area of the anterior foot arch, the medial area of the posterior foot arch, and the lateral area of the third metatarsal bone. After the patient wears the foot intelligent wearable device, the main control chip 12 activates the distributed sensor array of the pressure sensing unit 13 to collect 30-second baseline pressure data in the state where the airbag 5 is not inflated. Then the micro air pump starts and maintains the reference air pressure to be filled into the main airbag 5, and the air supply solenoid valves are sequentially opened according to a preset time sequence to realize the inflation of different sub-airbags 5, so that the reference air pressure in each sub-airbag 5 reaches the level of the main airbag 5. At this time, the disease areas of the high-risk diabetic foot are selected, that is, the pressure measurement areas corresponding to the lateral area of the anterior foot arch, the medial area of the posterior foot arch, and the lateral area of the third metatarsal bone. Based on the pressure values of the above three pressure measurement areas, the actual air exhaust and air intake amounts required for decompression in the above three pressure measurement areas are respectively calculated. The main control chip 12 calculates the opening degrees and deflation times of the corresponding air release solenoid valves 6 in the above three pressure measurement areas, and controls the corresponding air release solenoid valves 6 to act according to the calculated opening degrees and deflation times to perform decompression adjustment on the airbags 5 in the above three pressure measurement areas, while keeping the other places unchanged. In this way, the downward pressure borne by the disease areas of the high-risk diabetic foot can be greatly reduced, thereby promoting the recovery of the disease areas of the high-risk diabetic foot, especially the sole ulcer surfaces, without pressure.

[0054] For a detailed understanding, those skilled in the art can refer to the specific content in another utility model patent of the inventor, "A Biological Pressure Feedback Regulation Device for Diabetic Foot".

[0055] Please refer to Figure 2 , the second aspect of the present invention discloses a method for identifying pressure points of diabetic foot, and the method includes the following steps:

[0056] S1. Fit and fix the foot intelligent wearable device to the sole. The foot intelligent wearable device has a plurality of pressure measurement areas corresponding one by one to different partitions of the sole of the diabetic foot, and collect the baseline pressure signals and the actual sole pressure signals of each pressure measurement area;

[0057] S2. According to the preset sensor calibration coefficient, convert the actual sole pressure signals of each pressure measurement area into regional pressure values, and combine the contact areas of each pressure measurement area obtained in advance to calculate the pressure values of each pressure measurement area;

[0058] S3. By comparing the pressure values of each pressure measurement area with the safety thresholds of the corresponding partitions, identify the disease areas and non-disease areas of the high-risk diabetic foot in each pressure measurement area;

[0059] S4. For the pressure measurement area corresponding to the onset area of high-risk diabetic foot, based on the pressure value of this pressure measurement area, calculate the actual air reduction and exhaust volume required for decompression of this pressure measurement area;

[0060] S5. Based on the actual air reduction and exhaust volume, calculate the opening degree and exhaust time of the exhaust solenoid valve 6 corresponding to this pressure measurement area. The foot intelligent wearable device adjusts the pressure reduction for the abnormal pressure measurement area based on the opening degree adjustment and exhaust time.

[0061] This method realizes the dynamic management of the pressure of diabetic foot through multi-modal data fusion and closed-loop control. In the initial stage, the intelligent wearable device collects the baseline pressure signal of the wearer when the airbag 5 is not inflated. This data reflects the natural pressure distribution of the foot and the deformation characteristics of the device body. When the device is inflated with the reference pressure, the system performs signal conversion in combination with the preset sensor calibration parameters. The calibration coefficient matrix includes temperature drift compensation and non-linear correction data to ensure the accuracy of the pressure value conversion. Combining the contact area of each pressure measurement area obtained in advance, by dividing the regional pressure value by the contact area, the pressure value of each pressure measurement area is obtained. The contact area of each pressure measurement area is established through foot three-dimensional scanning data and gait analysis results. By comparing the pressure values of each pressure measurement area with the safety thresholds of the corresponding partitions, identify the onset areas and non-onset areas of high-risk diabetic foot in each pressure measurement area;

[0062] For the pressure measurement area corresponding to the onset area of high-risk diabetic foot, based on the pressure value of this pressure measurement area, calculate the actual air reduction and exhaust volume required for decompression of this pressure measurement area, that is, the volume of gas to be released. Based on the actual air reduction and exhaust volume, calculate the opening degree and exhaust time of the corresponding exhaust solenoid valve 6. The opening degree reflects the valve flow capacity, and the exhaust time reflects the duration of the decompression requirement, and drive the solenoid valve to act according to the calculated parameters. By adjusting the opening degree and controlling the exhaust time, decompress the airbag 5 in the pressure measurement area corresponding to the onset area of high-risk diabetic foot, so that the pressure in the pressure measurement area corresponding to the onset area of high-risk diabetic foot decreases, while the non-onset area remains unchanged. In this way, the downward pressure borne by the onset area of high-risk diabetic foot can be reduced, providing a pressure-free or low-pressure rehabilitation environment for the onset area of the sole, thereby promoting the rehabilitation of the onset area of high-risk diabetic foot, especially the sole ulcer surface without pressure.

[0063] In some embodiments, the intelligent foot wearable device has multiple pressure measurement regions, and an airbag 5 is correspondingly arranged in each pressure measurement region. At least one pressure sensor is deployed in each pressure measurement region. The pressure measurement regions include the medial region of the first metatarsal bone, the middle region of the second metatarsal bone, the lateral region of the third metatarsal bone, the medial region of the forefoot arch, the lateral region of the forefoot arch, the medial region of the rearfoot arch, the lateral region of the rearfoot arch, and the heel region. The medial region of the first metatarsal bone corresponds to the region under the root of the big toe. The middle region of the second metatarsal bone corresponds to the region under the roots of the second and third toes. The lateral region of the third metatarsal bone corresponds to the region under the roots of the fourth and fifth toes.

[0064] The division of the pressure measurement regions is accurately positioned according to the foot biomechanical characteristics and the high-incidence sites of diabetic foot ulcers. The medial region of the first metatarsal bone corresponds to the area under the root of the big toe, where about 30% of the peak plantar pressure is borne during the gait propulsion phase. Excessive pressure is likely to cause ulcer formation at the metatarsophalangeal joint. The middle region of the second metatarsal bone covers the area under the roots of the second and third toes. The local pressure concentration phenomenon caused by the collapse of the transverse arch in this region is significant. Early risk of metatarsal stress fractures can be identified through independent monitoring. The lateral region of the third metatarsal bone corresponds to the roots of the fourth and fifth toes. The skin cutin layer here is relatively thin and the blood supply is poor. Abnormal pressure is likely to cause intractable ulcers. The medial and lateral regions of the forefoot arch respectively correspond to the stress concentration areas of the dynamic support of the foot arch. The medial region monitors the degree of collapse of the longitudinal arch, and the lateral region identifies abnormal pronation gait. The division of the medial and lateral regions of the rearfoot arch can distinguish the varus / valgus tendency when the heel touches the ground. The heel region focuses on monitoring the vertical impact force. There is a high correlation between the excessive pressure in this region and the occurrence of calcaneal ulcers.

[0065] In some embodiments, the step of converting the original pressure signals of each pressure measurement region into regional pressure values according to the preset sensor calibration coefficients includes: for the multiple pressure sensors deployed in each pressure measurement region, respectively applying the corresponding sensor calibration coefficients to convert the original voltage signals into pressure values; performing weighted averaging on the output values of the multiple pressure sensors in the same pressure measurement region to obtain the final pressure value of this region, where the weight coefficients are pre-calibrated based on the position distribution and sensitivity characteristics of each sensor in the region.

[0066] Specifically, after acquiring the pressure signal, the sensor calibration parameters pre-stored in the chip are called. These parameters include the sensitivity characteristics and zero offsets of each sensor under standard pressure. The raw voltage signal collected is converted into a physical pressure value through a linear compensation algorithm. For multiple sensors distributed within the same pressure measurement area, according to their spatial positions and sensitivity distribution characteristics, a weighted average algorithm is used to fuse the outputs of each sensor to generate the comprehensive pressure value of this area. The pre-established plantar contact area database is retrieved. This database is obtained through the static three-dimensional scanning of the foot and dynamic gait analysis when the user first wears the device. The real-time contact area data corresponding to the current gait phase is matched. Finally, the area comprehensive pressure value is divided by the corresponding contact area, and the accurate pressure value of each area is output.

[0067] In some embodiments, the contact area of each pre-acquired pressure measurement area is obtained in the following manner: When the user first uses the device, through the pressure distribution scan in the static standing posture, the initial contact area of each pressure measurement area is segmented and calculated; during the dynamic walking process, based on the pressure distribution data of multiple consecutive gait cycles, the contact area of each pressure measurement area is corrected in real time, where the correction coefficient is dynamically adjusted based on the gait phase recognition result.

[0068] Specifically, when the user first wears the device, they are guided to maintain a static standing posture. The plantar pressure distribution data is obtained through the pressure sensor array built into the insole 1. The boundary of the pressure measurement area corresponding to each anatomical partition is identified using an image segmentation algorithm, and the initial contact area of each area is calculated and stored in the user profile. During the dynamic walking stage, the system captures the pressure distribution time series data in consecutive gait cycles in real time, identifies the current gait phase state, and dynamically adjusts the contact area correction coefficient according to the change law of the foot contact area. For example, the area weight of the heel area is automatically increased during the heel strike phase, and the calculation of the effective contact area of the forefoot area is strengthened during the propulsion phase. Through multi-cycle data iterative optimization, the system constructs a personalized contact area - gait phase mapping model to achieve real-time adaptive correction of the contact area of each pressure measurement area during walking.

[0069] In some embodiments, when calculating the actual exhaust gas reduction volume required for pressure reduction in this pressure measurement area, first calculate the difference between the current pressure value of the airbag 5 and the target safety pressure. Combining with the volume parameter of the airbag 5, use the ideal gas law to calculate the theoretical exhaust gas reduction volume. Subsequently, call the pre-stored material elasticity correction curve, which is obtained through the compression and rebound test of the material of the airbag 5 in the laboratory. Match the corresponding correction coefficient according to the elastic deformation interval where the current pressure value of the airbag 5 is located. Finally, multiply the theoretical exhaust gas reduction volume by the correction coefficient to obtain the actual exhaust gas reduction volume output value. The entire calculation process is completed within 50 milliseconds to ensure the real-time performance of pressure regulation. The specific calculation process is as follows:

[0070] Calculate the theoretical exhaust gas reduction volume Q based on the following formula LL :

[0071]

[0072] Obtain the elastic correction coefficient C through the stress-strain characteristic curve of the airbag material e , and obtain the actual exhaust gas reduction volume Q based on the correction coefficient SJ : Q SJ =Q LL *C e ;

[0073] where V is the current volume of the airbag, P c is the current airbag pressure, P s is the safety pressure threshold, P atm is the standard atmospheric pressure

[0074] Furthermore, calculate the current airbag pressure, specifically including:

[0075] Convert the baseline pressure signal in each pressure measurement area into a baseline pressure value according to the preset sensor calibration coefficient

[0076] Combine the dynamic correction factor, the contact area of each pressure measurement area, and the baseline pressure value, and calculate the current airbag pressure value using the following formula

[0077]

[0078] where F QY is the regional pressure value, F JX is the baseline pressure value, A eff is the contact area between the sole and the foot smart wearable device, γ is the temperature compensation coefficient, T n is the set environmental temperature, T0 is the reference calibration temperature, C creep is the material creep coefficient

[0079] Optionally, based on the actual exhaust gas reduction volume, calculate the opening degree and deflation time of the deflation solenoid valve corresponding to this pressure measurement area, specifically including:

[0080] Establish an objective function aiming to obtain the optimal time cost and equipment loss, and set the pressure constraint condition and engineering constraint condition, where the objective function is

[0081]

[0082] where is the time weight coefficient, τ is the equipment loss parameter, k opt is the optimal efficiency opening degree

[0083] where the time cost term reflects the requirement for the treatment response speed, and the equipment loss term τ|k - k opt | is used to control the mechanical wear of the solenoid valve. The time weight coefficient is set according to clinical needs, the equipment loss parameter is determined based on the solenoid valve durability test data, and the optimal efficiency opening is determined through the peak value of the valve flow characteristic curve.

[0084] The pressure constraint system includes multi-dimensional safety restrictions. The primary condition is to ensure that the pressure value after decompression is always within the personalized safety range, which is dynamically adjusted according to the patient's foot ulcer risk and is usually set to 80% to 120% of the reference safety threshold. Secondly, strictly control the pressure drop rate to prevent sudden pressure drops from causing tissue perfusion disorders, specifically manifested as the pressure change per unit time not exceeding 15% of the target value. At the same time, set the upper limit of the pressure difference between adjacent pressure measurement areas to avoid local over-decompression causing compensatory pressure increases in the surrounding areas.

[0085] The engineering constraint conditions focus on the physical limitations of the equipment and the operational feasibility. The opening of the solenoid valve is restricted within the mechanical safety range of 20% to 95%, which can not only ensure sufficient gas flow control accuracy but also prevent valve jamming. The operation time is set to a minimum of 0.5 seconds to ensure the reliability of pressure sensor data acquisition and a maximum of 10 seconds to avoid treatment response delays. For the airbag deformation limit, it is stipulated that the airbag volume change in a single adjustment shall not exceed 30% of the initial volume. This threshold is derived from the fatigue characteristic test data of the silicone material and can effectively prevent premature material failure.

[0086] Encoding the deflation time T and the opening parameter k as a real vector [T, k], using the improved NSGA-II algorithm to gradually solve for the deflation time T and the opening parameter k, and finally finding the optimal solution for the deflation time T and the opening parameter k.

[0087] Specifically, the optimization algorithm uses an improved multi-objective genetic algorithm for solution. When the algorithm is initialized, 50 groups of candidate solutions including time and opening are randomly generated. By simulating the biological evolution mechanism, the solutions that perform excellently in terms of time efficiency and equipment loss are retained in each round of iteration. The dynamic constraint processing module imposes an exponential penalty on the solutions that do not meet the pressure safety range or engineering restrictions, forcing the algorithm to search within the feasible domain. After 500 generations of evolution, the algorithm outputs a set of optimal parameter combinations. During actual adjustment, the deflation solenoid valve is adjusted based on this parameter combination, so that part of the gas in the airbag is discharged.

[0088] The above is only the specific implementation manner of the present invention, but the protection scope of the present invention is not limited thereto. Any person skilled in the art within the technical scope disclosed by the present invention can easily think of changes or substitutions, which should all be covered within the protection scope of the present invention. The protection scope of the present invention shall be subject to the protection scope of the claims.

Claims

1. A biological pressure feedback regulation device for diabetic foot, the pressure feedback regulation device comprising a foot intelligent wearable device and an insole disposed in the foot intelligent wearable device, characterized in that, The insole is composed of a contact layer, a pressure reduction layer, and a protection layer from top to bottom. Multiple independent pressure measurement areas are defined in the pressure reduction layer. An airbag is correspondingly arranged in each pressure measurement area. An air release solenoid valve is provided on all the airbags. One of the airbags is designated as the main airbag, and the rest are auxiliary airbags. The main airbag is connected to each auxiliary airbag through an air delivery channel. A first air delivery solenoid valve is provided on the main airbag and is connected to an air pump. A second air delivery solenoid valve is provided on the air delivery channel. A main control chip and a separate pressure sensing unit are provided between the airbag in each pressure measurement area and the protection layer. The pressure sensing unit, the first air delivery solenoid valve, the second air delivery solenoid valve, and the main control chip are electrically connected.

2. The biological pressure feedback regulation device for diabetic foot according to claim 1, wherein The pressure sensing unit includes a distributed pressure sensor array arranged on the bottom surface of the pressure reduction layer.

3. A method for identifying diabetic foot pressure points, characterized in that, The method includes the following steps: Fix the foot intelligent wearable device on the sole of the foot. The foot intelligent wearable device has multiple pressure measurement areas corresponding one by one to different partitions of the sole of a diabetic foot, and collect the baseline pressure signals and the actual sole pressure signals of each pressure measurement area. According to the preset sensor calibration coefficient, convert the actual sole pressure signals of each pressure measurement area into regional pressure values, and combine the contact areas of each pressure measurement area obtained in advance to calculate the pressure values of each pressure measurement area. By comparing the pressure values of each pressure measurement area with the safety thresholds of the corresponding partitions, identify the diseased areas and non-diseased areas of diabetic high-risk feet in each pressure measurement area. For the pressure measurement area corresponding to the diseased area of diabetic high-risk feet, based on the pressure value of this pressure measurement area, calculate the actual air reduction and exhaust volume required for pressure reduction in this pressure measurement area.

4. The method for identifying diabetic foot pressure points according to claim 3, wherein Based on the actual air reduction and exhaust volume, calculate the opening degree and the air release time of the air release solenoid valve corresponding to this pressure measurement area. The foot intelligent wearable device performs pressure reduction adjustment on the abnormal pressure measurement area based on the opening degree adjustment and the air release time.

5. The method for identifying diabetic foot pressure points according to claim 4, characterized in that, The pressure measurement areas include the medial area of the first metatarsal bone, the middle area of the second metatarsal bone, the lateral area of the third metatarsal bone, the medial area of the anterior foot arch, the lateral area of the anterior foot arch, the medial area of the posterior foot arch, the lateral area of the posterior foot arch, and the heel area. Among them, the medial area of the first metatarsal bone corresponds to the area under the root of the big toe, the middle area of the second metatarsal bone corresponds to the area under the roots of the second and third toes, and the lateral area of the third metatarsal bone corresponds to the area under the roots of the fourth and fifth toes. The step of converting the original pressure signals of each pressure measurement area into regional pressure values according to the preset sensor calibration coefficient includes: for multiple pressure sensors deployed in each pressure measurement area, respectively apply the corresponding sensor calibration coefficient to convert the original voltage signal into a pressure value; perform weighted averaging on the output values of the multiple pressure sensors in the same pressure measurement area to obtain the final pressure value of this area, where the weight coefficient is pre-calibrated based on the position distribution and sensitivity characteristics of each sensor in the area.

6. The method for identifying diabetic foot pressure points according to claim 5, wherein The contact areas of the pre-acquired pressure measurement regions are obtained in the following manner: when the user first uses the device, the initial contact areas of the pressure measurement regions are segmented and calculated through pressure distribution scanning in a static standing posture; During dynamic walking, based on the pressure distribution data of consecutive multiple gait cycles, the contact areas of the pressure measurement regions are corrected in real time, where the correction coefficient is dynamically adjusted based on the gait phase recognition result.

7. A method for identifying diabetic foot pressure points according to claim 6, characterized in that, Calculating the actual exhaust gas reduction volume required for pressure reduction in this pressure measurement region specifically includes: Calculate the theoretical exhaust gas reduction Q based on the following formula LL :[[]]END]] Obtain the elastic correction coefficient C from the stress-strain characteristic curve of the airbag material e , and obtain the actual emission reduction exhaust volume Q based on the correction coefficient SJ : Q SJ = Q LL * C e ; Among them, V is the current volume of the airbag, and P c is the current airbag pressure, P s is the safety pressure threshold, and P atm is the standard atmospheric pressure.

8. A method for identifying diabetic foot pressure points according to claim 7, characterized in that Calculating the current airbag pressure specifically includes: According to the preset sensor calibration coefficient, converting the baseline pressure signal of each pressure measurement region into a baseline pressure value; Combining the dynamic correction factor, the contact area of each pressure measurement region, and the baseline pressure value, calculating the current airbag pressure value using the following formula: Among them, F QY is the regional pressure value, F JX is the baseline pressure value, A eff is the contact area between the sole of the foot and the intelligent wearable device for the foot, γ is the temperature compensation coefficient, T n is the set ambient temperature, T0 is the reference calibration temperature, C creep is the material creep coefficient.

9. The method for identifying diabetic foot pressure points according to claim 8, wherein Based on the actual exhaust gas reduction volume, calculating the opening degree and deflation time of the deflation solenoid valve corresponding to this pressure measurement region specifically includes: Establishing an objective function with the goal of obtaining the optimal time cost and equipment loss, and setting pressure constraints and engineering constraints, where the objective function is: Among them, is the time weight coefficient, τ is the equipment loss parameter, and k opt is the optimal efficiency opening; Encoding the deflation time T and the opening degree parameter k as a real vector [T, k], and using the improved NSGA-II algorithm to gradually solve for the deflation time T and the opening degree parameter k, and finally finding the optimal solution for the deflation time T and the opening degree parameter k.

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