Diabetic foot biological pressure feedback adjusting device

Abstract

The utility model discloses a diabetic foot biological pressure feedback adjusting device which comprises a shoe body and a shoe pad arranged in the shoe body, the shoe pad is sequentially composed of a contact layer, a pressure reduction layer and a protection layer from top to bottom, the pressure reduction layer is divided into a plurality of independent pressure measurement areas, an air bag is correspondingly arranged in each pressure measurement area, and the air bag is connected with the contact layer. All the air bags are provided with deflation electromagnetic valves, one of the air bags is designated as a main air bag, the other air bags are auxiliary air bags, the main air bag is connected with the auxiliary air bags through an air conveying channel, the main air bag is provided with a first air conveying electromagnetic valve and is connected with an air pump, and the air conveying channel is provided with a second air conveying electromagnetic valve. A main control chip and an independent pressure sensing unit are arranged between the air bag in each pressure measurement area and the protective layer, and the pressure sensing units, the first air transmission electromagnetic valve and the second air transmission electromagnetic valve are all electrically connected with the main control chip.

Description

Technical Field

[0001] This utility model relates to the field of functional footwear technology, and in particular to a bio-pressure feedback regulation device for diabetic foot. Background Technology

[0002] Diabetic foot, a serious complication of late-stage diabetes, stems from the synergistic effect of multiple factors: long-term hyperglycemia leads to peripheral neuropathy resulting in loss of protective sensation in the foot; microvascular disease causes insufficient tissue perfusion; and biomechanical abnormalities cause distorted plantar pressure distribution. These three factors combine to form a vicious cycle of ulcer formation. During walking, compensatory gait adjustments caused by proprioceptive impairment result in peak vertical stress in key anatomical areas such as the metatarsal heads and arch transition zone of the forefoot exceeding normal values ​​by 2-3 times. The shear force in the epidermal layer of abnormally high-pressure areas can reach 4.6 times that of healthy individuals, ultimately leading to ischemic necrosis of subcutaneous tissue and the formation of chronic wounds that are difficult to heal.

[0003] Current pressure-adjustable insoles have significant limitations in terms of personalized fit and dynamic adjustment. The Chinese utility model patent CN212661252U discloses a diabetic foot support insole that uses an elastic support body and a mesh groove to adjust plantar pressure, providing an adjustable support structure to some extent. However, this solution still relies on a static layout with pre-implanted elastic support bodies, requiring manual adjustment of the number and position of the support bodies according to the patient's plantar pressure distribution. Automatic adjustment is not possible, and as the patient's condition progresses, the plantar pressure distribution may change, necessitating manual intervention to readjust the support body layout again. This is not only cumbersome but also significantly increases usage costs. Secondly, the aforementioned existing technology struggles to achieve precise pressure control for specific affected areas. Its integrated support structure cannot independently reduce the load on a high-pressure area, and when distributing pressure, it may affect the normal support function of other areas, resulting in a one-size-fits-all pressure adjustment that cannot provide a targeted pressure-free or low-pressure rehabilitation environment for sensitive areas such as plantar ulcers. Summary of the Invention

[0004] In view of the above-mentioned prior art, the present invention provides a bio-pressure feedback regulation device for diabetic foot, which mainly solves the technical problems existing in the background art.

[0005] To achieve the above objectives, the technical solution of this utility model embodiment is implemented as follows:

[0006] A bio-pressure feedback regulation device for diabetic foot includes a shoe body and an insole disposed in the shoe body. The insole consists of a contact layer, a pressure-reducing layer, and a protective layer from top to bottom. The pressure-reducing layer is divided into multiple independent pressure measurement areas, and an airbag is disposed in each pressure measurement area. All airbags are equipped with a deflation solenoid valve. One airbag 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. The main airbag is equipped with a first air supply solenoid valve 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 disposed between the airbag in each pressure measurement area and the protective layer. The pressure sensing unit, the first air supply solenoid valve, and the second air supply solenoid valve are all electrically connected to the main control chip.

[0007] Optionally, the pressure sensing unit includes a distributed pressure sensor array.

[0008] Optionally, the pressure measurement area includes the medial region of the first metatarsal, the middle region of the second metatarsal, the lateral region of the third metatarsal, the medial region of the forefoot arch, the lateral region of the forefoot arch, the medial region of the hindfoot arch, the lateral region of the hindfoot arch, and the heel region, wherein the medial region of the first metatarsal corresponds to the region below the base of the big toe, the middle region of the second metatarsal corresponds to the region below the base of the second and third toes, and the lateral region of the third metatarsal corresponds to the region below the base of the fourth and fifth toes.

[0009] Optionally, the gas delivery channel includes a first main gas delivery channel and a second main gas delivery channel, which are respectively located on both sides of the decompression layer. The first main gas delivery channel and the second main gas delivery channel are respectively connected to the airbag through corresponding sub-channels.

[0010] Optionally, the second gas delivery solenoid valve is disposed on the gas delivery sub-channel.

[0011] Optionally, the protective layer is a rigid plastic substrate, and the pressure sensing unit is fixed on the surface of the substrate.

[0012] Optionally, multiple pressure sensing units are provided between the airbag and the protective layer in each pressure measurement area.

[0013] The beneficial effects of this utility model are as follows: 1. By dividing the decompression layer into multiple independent pressure measurement areas, each area is equipped with an airbag, and each airbag is equipped with a deflation solenoid valve. Before the patient wears the device, the external air pump injects gas through the first gas delivery solenoid valve of the main airbag. The main airbag does not store gas in advance, but only serves as a transfer hub. The main control chip opens the second gas delivery solenoid valve on the gas delivery sub-channel in a preset order. The gas is directly delivered to the target auxiliary airbag through the gas delivery channel. When the airbag in the target area inflates, the pressure sensing unit of that area obtains the pressure value in real time and feeds it back to the main control chip. If the pressure value reaches the preset standard, the main control chip closes the second gas delivery solenoid valve corresponding to the pressure measurement area. This process continues until all main airbags and auxiliary airbags are filled with rated pressure gas. This process achieves accurate construction of airbag pressure in each area through partitioned sequential inflation and real-time pressure monitoring.

[0014] 2. The pressure sensor unit continuously monitors the pressure values ​​of each pressure measurement area. If an abnormal pressure value is detected in a certain pressure measurement area, the area is identified as a high-risk area for diabetic foot lesions, such as the area corresponding to plantar ulcers. The main control chip calculates the actual reduction in air volume and the opening degree and air release time of the corresponding air release solenoid valve based on the pressure value of the area, and controls the solenoid valve to act according to the calculated parameters to precisely depressurize the airbag in the abnormal pressure area. This mechanism can significantly reduce the pressure in the high-risk area for diabetic foot lesions, while the pressure in other areas remains unchanged, thereby providing a pressure-free or low-pressure rehabilitation environment for the affected areas such as plantar ulcers, effectively promoting the healing of the lesions. Attached Figure Description

[0015] Figure 1 This is a schematic diagram of the insole structure in an embodiment of this application;

[0016] Figure 2 This is a schematic diagram showing the placement of the main control chip and the pressure sensing unit in an embodiment of this application;

[0017] Figure 3 This is a side view of the insole in an embodiment of this application.

[0018] Explanation of icon numbers:

[0019] 1. Insole; 2. Contact layer; 3. Pressure-reducing layer; 4. Protective layer; 5. Airbag; 6. De-gas 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. Sub-channel for air supply; 12. Main control chip; 13. Pressure sensing unit; 14. Air pump. Detailed Implementation

[0020] The technical solution of this utility model will be further described in detail below with reference to the accompanying drawings and specific embodiments. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this utility model belongs. The terminology used in this specification of this utility model is for the purpose of describing particular embodiments only and is not intended to limit the utility model. In the following description, the expression "some embodiments" refers to a subset of all possible embodiments; however, 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.

[0021] In the following description, numerous specific details are set forth in order to provide a more thorough understanding of the present invention. However, it will be apparent to those skilled in the art that the present invention can be practiced without one or more of these details. In other instances, certain technical features well-known in the art have not been described in order to avoid confusion with the present invention.

[0022] It should be understood that this invention can be embodied in various forms and should not be construed as limited to the embodiments set forth herein. Rather, providing these embodiments will make the disclosure thorough and complete, and will fully convey the scope of this invention to those skilled in the art. Furthermore, the terminology used herein is intended only to describe particular embodiments and is not intended to limit the 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 “compose” and / or “comprising,” when used in this specification, identify the presence of the stated features, integers, steps, operations, elements, and / or components, but do not exclude 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 associated listed items.

[0023] It should also be noted that when an element is referred to as being "fixed to" another element, it can be directly attached to the other element or there may be an intervening element. When an element is referred to as being "connected to" another element, it can be directly connected to the other element or there may be an intervening element. The terms "vertical," "horizontal," "inner," "outer," "left," "right," and similar expressions used herein are for illustrative purposes only and do not represent the only possible implementation.

[0024] To fully understand this utility model, a detailed structure will be presented in the following description to illustrate the technical solution proposed by this utility model. Optional embodiments of this utility model are described in detail below; however, in addition to these detailed descriptions, this utility model may have other embodiments.

[0025] Please refer to the attached document. Figure 1 This application provides a bio-pressure feedback adjustment device for diabetic foot, including a shoe body and an insole 1 disposed in the shoe body. The insole 1 is composed of a contact layer 2, a pressure-reducing layer 3, and a protective layer 4 from top to bottom. The pressure-reducing layer 3 is divided into multiple independent pressure measurement areas, and an airbag 5 is disposed in each pressure measurement area. All airbags 5 are provided with a deflation solenoid valve. One of the airbags 5 is designated as a 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. The main airbag 5 is provided with a first air supply solenoid valve 7 and is connected to an air pump 14. The air supply channel is provided with a second air supply solenoid valve 8. A main control chip 12 and a separate pressure sensing unit 13 are disposed between the airbag 5 in each pressure measurement area and the protective 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.

[0026] Specifically, the bio-pressure feedback regulation device for diabetic foot provided in this application is applied to the plantar pressure regulation of patients with high-risk diabetic foot. It can achieve dynamic adjustment of pressure in specific areas of the sole. The pressure-reducing layer 3 is divided into multiple independent pressure measurement areas, and each area is equipped with an airbag 5. Each airbag 5 is equipped with a deflation solenoid valve. Before the patient wears the device, the external air pump 14 injects gas through the first gas delivery solenoid valve 7 of the main airbag 5. The main airbag 5 does not pre-store gas but only serves as a transfer hub. The main control chip 12 sequentially inflates the airbags according to a preset order. The second gas delivery solenoid valve 8 on the gas delivery channel 11 is opened, and the gas is directly delivered to the target auxiliary airbag 5 through the gas delivery channel. When the airbag 5 in the target area inflates, the pressure sensing unit 13 in that area acquires the pressure value in real time and feeds it back to the main control chip 12. If the pressure value reaches the preset standard, the main control chip 12 closes the second gas delivery solenoid valve 8 corresponding to the pressure measurement area. This process continues until all the main airbags 5 and auxiliary airbags 5 are filled with rated pressure gas. This process achieves accurate pressure construction of airbags 5 in each area through zoned sequential inflation and real-time pressure monitoring.

[0027] When a patient with high-risk diabetic foot puts their foot into the shoe, the contact layer 2 of the insole 1 fits against the sole of the foot. The pressure sensing unit 13 continuously monitors the pressure value of each pressure measurement area. If an abnormal pressure value is detected in a certain pressure measurement area, the area is identified as the lesion area of ​​high-risk diabetic foot, such as the area corresponding to a plantar ulcer. The main control chip 12 calculates the actual air reduction volume and the opening degree and air release time of the corresponding air release solenoid valve based on the pressure value of the area, and controls the solenoid valve to act according to the calculated parameters to precisely depressurize the airbag 5 in the abnormal pressure area. This mechanism can significantly reduce the pressure in the lesion area of ​​high-risk diabetic foot, while the pressure in other areas remains unchanged, thereby providing a pressure-free or low-pressure rehabilitation environment for the lesion area such as the plantar ulcer, effectively promoting the healing of the lesion area.

[0028] It should be noted that the main control chip 12 calculates the specific estimate of the actual reduction in exhaust volume based on the pressure value of the area. In the pressure feedback regulation device described in this patent, the electrical connection and functional interaction between the main control chip 12, the pressure sensing unit 13, and the solenoid valve are part of the product structure. Their structural relationship has been clearly defined by the content such as "the pressure sensing unit 13, the solenoid valve, and the main control chip 12 are electrically connected". The specific process by which the main control chip 12 calculates the actual reduction in exhaust volume based on the pressure value belongs to the category of software algorithm or control method, and is not the shape or structural feature of the product. Therefore, it is not protected by the utility model patent. This embodiment will not describe it in detail here. If you need to understand it in detail, those skilled in the art can refer to the specific content of the inventor's other invention patent "A Diabetic Foot Bio-Pressure Feedback Regulation Device and Pressure Point Identification Method".

[0029] Secondly, the main control chip 12 drives the second gas supply solenoid valve 8 or the gas release solenoid valve based on the calculated parameters or the detection parameters obtained by the pressure sensing unit 13. This method of driving the actuator through logic control is a conventional technical means. Those skilled in the art can achieve this based on the general control principle of sensor signal processing and actuator driving. Therefore, this embodiment will not describe this control process in detail.

[0030] In some embodiments, the pressure measurement area includes the medial region of the first metatarsal, the middle region of the second metatarsal, the lateral region of the third metatarsal, the medial region of the forefoot arch, the lateral region of the forefoot arch, the medial region of the hindfoot arch, the lateral region of the hindfoot arch, and the heel region, wherein the medial region of the first metatarsal corresponds to the region below the base of the big toe, the middle region of the second metatarsal corresponds to the region below the base of the second and third toes, and the lateral region of the third metatarsal corresponds to the region below the base of the fourth and fifth toes.

[0031] Specifically, the medial region of the first metatarsal corresponds to the area below the base of the big toe, which is one of the main stress points of the forefoot. Diabetic patients are prone to ulcers here due to concentrated pressure. The middle region of the second metatarsal covers the area below the bases of the second and third toes, and the lateral region of the third metatarsal corresponds to the area below the bases of the fourth and fifth toes. These two areas respectively bear the pressure transmission of the middle and lateral sides of the forefoot. The pressure distribution in the metatarsal regions corresponding to different toes varies significantly and requires independent monitoring. The medial and lateral regions of the forefoot arch and the medial and lateral regions of the hindfoot arch are arranged around the arch structure. As the elastic support structure of the foot, the pressure balance between the medial and lateral sides of the arch is crucial for overall gait and pressure distribution. Abnormal pressure in the arch area of ​​diabetic patients may lead to arch collapse or localized stress concentration. The heel area, as the initial contact point when standing and walking, bears the impact of the entire body weight and is one of the high-incidence areas for plantar ulcers. By dividing the decompression layer 3 into the above eight independent pressure measurement areas, each area is equipped with an independent airbag 5 and a pressure sensing unit 13.

[0032] In some embodiments, the gas supply channel includes a first main gas supply channel 9 and a second main gas supply channel 10, which are respectively disposed on both sides of the pressure reducing layer 3. The first main gas supply channel 9 and the second main gas supply channel 10 are respectively connected to the airbag 5 through corresponding sub-channels 11, and the second solenoid valve 8 is disposed on the sub-channels 11.

[0033] Specifically, the first main gas supply channel 9 and the second main gas supply channel 10 are arranged parallel to each other on the left and right sides of the pressure reduction layer 3, forming a symmetrical gas transmission network. The first main gas supply channel 9 and the second main gas supply channel 10 are connected to the airbags 5 of the corresponding pressure measurement areas one by one through several sub-channels 11. The second solenoid valve 8 is integrated into the port of the sub-channel 11 near the airbag 5. Controlled by the electrical signal of the main control chip 12, the gas passage of each sub-channel 11 can be opened or closed independently, making the gas transmission path short and efficient. It not only meets the needs of simultaneous gas supply to multiple areas, but also achieves independent adjustment of gas flow in a single area through the precise control of the second solenoid valve 8, avoiding pressure interference between areas. The symmetrical arrangement of the two main channels also helps to balance the overall force on the insole 1 and improve the stability of the device during the inflation process.

[0034] Furthermore, the protective layer 4 is a rigid plastic substrate, and the pressure sensing unit 13 is fixed on the surface of the substrate.

[0035] Furthermore, multiple pressure sensing units 13 are provided between the airbag 5 and the protective layer 4 in each pressure measurement area, and each pressure sensing unit 13 includes a distributed pressure sensor array.

[0036] The protective layer 4 is made of a rigid plastic substrate. Its rigid structure can effectively support foot pressure and protect the internal pressure relief layer 3 from external impact. At the same time, it provides a stable mounting base for the pressure sensing unit 13. The pressure sensing unit 13 is fixed to the substrate surface in a distributed array manner. Multiple sensing units are set for each pressure measurement area to form a grid-like monitoring layout. This allows each sensing unit to independently collect pressure data of the corresponding area. Multi-point sampling improves the accuracy and reliability of pressure detection.

[0037] Furthermore, the contact layer 2 material adopts a multi-layer composite structure to achieve synergistic functions of pressure buffering, antibacterial and bacteriostatic properties, and breathability and moisture wicking. The surface layer of contact layer 2 is made of ultra-soft medical silicone molded into a honeycomb hexagonal microstructure, which has multi-directional deformation capability to adapt to the pressure distribution of the sole of the foot, significantly reducing the local pressure peak and reducing the risk of secondary damage to the ulcer area. Micron-level pores are reserved between the honeycomb units to accelerate sweat evaporation. At the same time, the surface is treated with a non-porous smooth surface to avoid stain penetration and supports quick cleaning and disinfection with alcohol wipes. The middle layer of the contact layer adopts a composite high-elasticity breathable and moisture-wicking mesh fabric, which is woven with ultra-fine denier fibers to form a three-dimensional channel. Combined with the pores of the silicone layer, it forms a directional moisture diffusion path to ensure that the feet are always dry. The bottom layer of contact layer 2, which is in contact with the skin, is treated with a brushing process to form an air buffer layer, reducing the coefficient of friction and improving contact comfort.

[0038] The above are merely specific embodiments of this utility model, but the protection scope of this utility model is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the technical scope disclosed in this utility model should be included within the protection scope of this utility model. The protection scope of this utility model should be determined by the protection scope of the stated claims.

Claims

1. A bio-pressure feedback adjustment device for diabetic foot, comprising a shoe body and an insole disposed within the shoe body, characterized in that, The insole consists of a contact layer, a pressure-reducing layer, and a protective layer from top to bottom. The pressure-reducing layer is divided into multiple independent pressure measurement areas, each with a corresponding airbag. All airbags are equipped with a deflation solenoid valve. One airbag is designated as the main airbag, and the rest are auxiliary airbags. The main airbag is connected to each auxiliary airbag via an air delivery channel. The main airbag has a first air delivery solenoid valve and is connected to an air pump. The air delivery channel has a second air delivery solenoid valve. Between the airbag in each pressure measurement area and the protective layer, there is a main control chip and a separate pressure sensing unit. The pressure sensing unit, the first air delivery solenoid valve, and the second air delivery solenoid valve are all electrically connected to the main control chip.

2. The bio-pressure feedback regulation device for diabetic foot according to claim 1, characterized in that, The pressure sensing unit includes a distributed pressure sensor array.

3. The bio-pressure feedback regulation device for diabetic foot according to claim 1, characterized in that, The pressure measurement area includes the medial region of the first metatarsal, the middle region of the second metatarsal, the lateral region of the third metatarsal, the medial region of the forefoot arch, the lateral region of the forefoot arch, the medial region of the hindfoot arch, the lateral region of the hindfoot arch, and the heel region. The medial region of the first metatarsal corresponds to the area below the base of the big toe, the middle region of the second metatarsal corresponds to the area below the base of the second and third toes, and the lateral region of the third metatarsal corresponds to the area below the base of the fourth and fifth toes.

4. The bio-pressure feedback regulation device for diabetic foot according to claim 1, characterized in that, The gas delivery channel includes a first main gas delivery channel and a second main gas delivery channel. The first main gas delivery channel and the second main gas delivery channel are respectively located on both sides of the decompression layer. The first main gas delivery channel and the second main gas delivery channel are respectively connected to the airbag through corresponding sub-channels.

5. The bio-pressure feedback regulation device for diabetic foot according to claim 4, characterized in that, The second gas delivery solenoid valve is installed on the gas delivery sub-channel.

6. The bio-pressure feedback regulation device for diabetic foot according to claim 1, characterized in that, The protective layer is a rigid plastic substrate, and the pressure sensing unit is fixed on the surface of the substrate.

7. The bio-pressure feedback regulation device for diabetic foot according to claim 1, characterized in that, Multiple pressure sensing units are provided between the airbag and the protective layer in each pressure measurement area.

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