阅读说明：本技术 多孔变刚度糖尿病足减压鞋垫及其制备方法 (Porous variable-rigidity diabetic foot pressure-reducing insole and preparation method thereof ) 是由 李剑 张明 潘国新 于 2020-12-29 设计创作，主要内容包括：本说明书一个或多个实施例提供一种多孔变刚度糖尿病足减压鞋垫及其制备方法,鞋垫包括本体,由若干小梁相互连接构成网状多孔结构,所述小梁中空形成气道；所述本体上对应足底不同压力区域设置不同的调节区域,各调节区域的气道的截面形状相同或者不同,截面形状的尺寸相同或者不同；在人体步态周期过程中,可利用充放气机构向所述气道充气或者放气,动态调节各调节区域的刚度和透气性。本实施例的鞋垫能够提供变化的刚度和透气性,有利于糖尿病足的康复。(One or more embodiments of the present specification provide a porous variable-stiffness diabetic foot decompression insole and a preparation method thereof, wherein the insole comprises a body, a plurality of trabeculae are connected with each other to form a net-shaped porous structure, and the trabeculae are hollow to form air passages; different adjusting areas are arranged on the body corresponding to different pressure areas of the sole, the cross sections of air passages of the adjusting areas are the same or different, and the cross sections are the same or different in size; in the human gait cycle process, the air inflation and deflation mechanism can be used for inflating or deflating the air passage, and the rigidity and the air permeability of each adjusting area are dynamically adjusted. The insole of this embodiment can provide variable rigidity and air permeability, is favorable to the recovery of diabetes foot.)

1. A porous variable stiffness diabetic foot pressure reduction insole comprising:

the body is of a reticular porous structure formed by mutually connecting a plurality of small beams, and the small beams are hollow to form an air passage;

different adjusting areas are arranged on the body corresponding to different pressure areas of the sole, the cross sections of air passages of the adjusting areas are the same or different, and the cross sections are the same or different in size;

in the human gait cycle process, the air inflation and deflation mechanism can be used for inflating or deflating the air passage, and the rigidity and the air permeability of each adjusting area are dynamically adjusted.

2. The insole according to claim 1, wherein the cross-sectional shape and the size of the cross-sectional shape of the air channel of each adjustment area are set according to the force-receiving characteristics of the different pressure areas.

3. The insole of claim 1, wherein said air channel has a cross-sectional shape of a circle, an ellipse, a star, or a rounded square, said rounded square having an arc shape at four vertices.

4. The insole of claim 3, wherein when said cross-sectional shape is circular, the cross-sectional dimension is the radius of the circle; when the cross section is in an elliptical shape, the size of the cross section is the major axis and the minor axis of the elliptical shape; when the shape of the cross section is a rounded square, the size of the cross section is the side length of the rounded square; when the cross-sectional shape is a star shape, the size of the cross-section is the diameter of an inscribed circle of the star shape.

5. The insole according to claim 1, wherein said sole is divided into a first pressure area, a second pressure area, a third pressure area and a fourth pressure area according to the arrangement of the pressure borne by the different pressure areas of the sole from large to small, said body is provided with a first regulation area, a second regulation area, a third regulation area and a fourth regulation area corresponding to said first pressure area, said second pressure area, said third pressure area and said fourth pressure area, respectively, and the stiffness of said first regulation area, said second regulation area, said third regulation area and said fourth regulation area are arranged from small to large.

6. The insole of claim 5, wherein said air passageways of said first conditioning region are star shaped in cross-section, said air passageways of said second conditioning region are circular in cross-section, said air passageways of said third conditioning region are oval in cross-section, and said air passageways of said fourth conditioning region are rounded square in cross-section; the cross-sectional shape has a size in the range of 1-4 mm.

7. The insole according to claim 1, wherein said body is provided with a first contact area in contact with the forefoot and a second contact area in contact with the arch, according to contact areas corresponding to different soles of the foot, the porous structure of said first contact area having a first porosity and the porous structure of said second contact area having a second porosity, said first porosity being greater than said second porosity.

8. A preparation method of a porous variable-rigidity diabetic foot decompression insole is characterized by comprising the following steps:

acquiring foot muscle and bone data of a foot of a patient;

reconstructing a three-dimensional model of the foot musculoskeletal of the foot of the patient according to the foot musculoskeletal data;

generating a solid insole model which is completely fit with the foot bottom shape of the foot of the patient according to the three-dimensional model of the foot musculoskeletal;

obtaining a plantar pressure test result of a foot of a patient;

determining different pressure areas of the patient foot according to the sole pressure test result;

setting different adjusting areas on the solid insole model according to the different pressure areas;

according to the different adjusting areas, building a structural body unit of each adjusting area; the structural body unit is a structure with pores and formed by a plurality of small beams, and the small beams are hollow to form air passages;

and splicing the structural body units of each adjusting area by using a modeling method to obtain the insole model with a net-shaped porous structure.

9. The method according to claim 8, wherein the creating of the structural unit of each adjustment region according to the different adjustment regions comprises:

the cross-sectional shape and the size of the cross-sectional shape of the gas passage of the structural unit are set according to different adjustment regions.

10. The method according to claim 9, wherein before setting the cross-sectional shape and the size of the cross-sectional shape of the gas passage of the structural unit according to the different adjustment regions, the method further comprises:

selecting the structural units according to different adjusting areas, and determining the shape parameters of the structural units; the shape parameter includes a cross-sectional dimension of the trabecula.

Technical Field

One or more embodiments of the specification relate to the technical field of rehabilitation aids, in particular to a porous variable-stiffness diabetic foot decompression insole and a preparation method thereof.

Background

China is a country with the largest population, the largest elderly and disabled people in the world. The nineteen five-middle-jiao together will clearly point out: a healthy multi-level social security system promotes the construction of healthy China comprehensively and implements the national strategy of actively coping with the aging of the population. The aging of the coping population is promoted to the national strategic level for the first time. With the increasing aging degree of China, the rehabilitation assistant tool plays a role in lifting the foot as a product for preventing, assisting, treating and compensating physiological dysfunction and functions of a human body.

The insole is a common life assistive device, can relieve foot pressure when being worn in daily life, prevents the sole from excessively rubbing the foot, and has the functions of foot health care, prevention and the like. The special insole can perform the functions of correction, fixation, rehabilitation and the like for patients with diabetic foot, flat foot, foot deformity and the like, and has the functions of preventing, treating, relieving foot diseases and the like. The data show that 1.1 hundred million people have diabetes in China, 4.9 million people have diabetes at the early stage, which is equivalent to one diabetes in every 10 people. About 30% of patients will develop diabetic feet, and the number of the diabetic feet in the whole country is about 4000 ten thousand. The prevention and treatment of diabetic foot are emphasized, and the amputation rate can be effectively reduced.

The traditional insole manufacturing method adopts manual manufacturing or machine manufacturing. The insole which is manually made mostly adopts fabrics such as cloth and the like, is manually sewn into a flat shape similar to the shape of a foot, does not have complete geometric matching characteristics with the three-dimensional shape of the foot, only has certain functions of preventing abrasion, slipping and the like, and is poor in wearing comfort. The insole manufactured by the machine is characterized in that the outline form of the foot is obtained by three-dimensional scanning, then an insole model which is matched with the geometric form of the foot and is reasonably stressed is designed by combining the biomechanics principle, and finally the insole is milled and carved by a CNC (computerized numerical control) machining center, so that the insole is comfortable to wear. However, most of insoles manufactured by the two methods are solid insoles, the air permeability is poor, and once the insoles are manufactured, the rigidity is basically fixed, so that the insoles are very unfavorable for foot rehabilitation of patients with diabetic feet and the like, and the conditions of non-healing wounds, infection, amputation and the like are easily caused.

Disclosure of Invention

In view of the above, one or more embodiments of the present disclosure are directed to a porous variable-stiffness diabetic foot pressure-reducing insole and a method for manufacturing the same, which has variable stiffness and air permeability and is beneficial to diabetic foot rehabilitation.

In view of the above, one or more embodiments of the present specification provide a porous variable stiffness diabetic foot pressure reduction insole comprising:

the body is of a reticular porous structure formed by mutually connecting a plurality of small beams, and the small beams are hollow to form an air passage;

different adjusting areas are arranged on the body corresponding to different pressure areas of the sole, the cross sections of air passages of the adjusting areas are the same or different, and the cross sections are the same or different in size;

in the human gait cycle process, the air inflation and deflation mechanism can be used for inflating or deflating the air passage, and the rigidity and the air permeability of each adjusting area are dynamically adjusted.

Optionally, the cross-sectional shape and the size of the cross-sectional shape of the air passage in each adjustment region are set according to the stress characteristics of different pressure regions.

Optionally, the cross-sectional shape of the air passage is a circle, an ellipse, a star or a rounded square, and the rounded square is a square with four arc-shaped vertexes.

Optionally, when the cross-sectional shape is a circle, the size of the cross-section is the radius of the circle; when the cross section is in an elliptical shape, the size of the cross section is the major axis and the minor axis of the elliptical shape; when the shape of the cross section is a rounded square, the size of the cross section is the side length of the rounded square; when the cross-sectional shape is a star shape, the size of the cross-section is the diameter of an inscribed circle of the star shape.

Optionally, the sole is divided into a first pressure region, a second pressure region, a third pressure region and a fourth pressure region according to the arrangement of different pressure regions of the sole from large to small, a first adjusting region, a second adjusting region, a third adjusting region and a fourth adjusting region corresponding to the first pressure region, the second pressure region, the third pressure region and the fourth pressure region are respectively arranged on the body, and the rigidity of the first adjusting region, the second adjusting region, the third adjusting region and the fourth adjusting region is arranged from small to large.

Optionally, the cross-sectional shape of the air passage of the first adjustment area is star-shaped, the cross-sectional shape of the air passage of the second adjustment area is circular, the cross-sectional shape of the air passage of the third adjustment area is oval, and the cross-sectional shape of the air passage of the fourth adjustment area is rounded square; the cross-sectional shape has a size in the range of 1-4 mm.

Optionally, the body is provided with a first contact area in contact with the forefoot and a second contact area in contact with the arch according to different contact areas corresponding to the sole of the foot, the porous structure of the first contact area has a first porosity, the porous structure of the second contact area has a second porosity, and the first porosity is greater than the second porosity.

The embodiment of the specification provides a preparation method of a porous variable-rigidity diabetic foot decompression insole, which comprises the following steps:

acquiring foot muscle and bone data of a foot of a patient;

reconstructing a three-dimensional model of the foot musculoskeletal of the foot of the patient according to the foot musculoskeletal data;

generating a solid insole model which is completely fit with the foot bottom shape of the foot of the patient according to the three-dimensional model of the foot musculoskeletal;

obtaining a plantar pressure test result of a foot of a patient;

determining different pressure areas of the patient foot according to the sole pressure test result;

setting different adjusting areas on the solid insole model according to the different pressure areas;

according to the different adjusting areas, building a structural body unit of each adjusting area; the structural body unit is a structure with pores and formed by a plurality of small beams, and the small beams are hollow to form air passages;

and splicing the structural body units of each adjusting area by using a modeling method to obtain the insole model with a net-shaped porous structure.

Optionally, the creating a structural unit of each adjustment region according to different adjustment regions includes:

the cross-sectional shape and the size of the cross-sectional shape of the gas passage of the structural unit are set according to different adjustment regions.

Optionally, before setting the cross-sectional shape and the size of the cross-sectional shape of the air passage of the structural unit according to the different adjustment regions, the method further includes:

selecting the structural units according to different adjusting areas, and determining the shape parameters of the structural units; the shape parameter includes a cross-sectional dimension of the trabecula.

From the above, the porous variable-stiffness diabetic foot decompression insole and the preparation method thereof provided by one or more embodiments of the specification comprise a body, a plurality of small beams are connected with each other to form a net-shaped porous structure, and the small beams are hollow to form air passages; different adjusting areas are arranged on the body corresponding to different pressure areas of the sole, the cross sections of air passages of the adjusting areas are the same or different, and the cross sections are the same or different in size; in the human gait cycle process, the air inflation and deflation mechanism can be used for inflating or deflating the air passage, and the rigidity and the air permeability of each adjusting area are dynamically adjusted. The insole of this embodiment can provide variable rigidity and air permeability, is favorable to the recovery of diabetes foot.

Drawings

In order to more clearly illustrate one or more embodiments or prior art solutions of the present specification, the drawings that are needed in the description of the embodiments or prior art will be briefly described below, and it is obvious that the drawings in the following description are only one or more embodiments of the present specification, and that other drawings may be obtained by those skilled in the art without inventive effort from these drawings.

FIG. 1 is a schematic perspective view of a body according to one or more embodiments of the present disclosure;

FIG. 2 is a schematic view of different pressure regions of the sole of a foot according to one or more embodiments of the present disclosure;

FIG. 3 is a schematic view of different conditioning regions on a body according to one or more embodiments of the present disclosure;

4A, 4B, 4C, 4D are schematic trabecular cross-sectional views of one or more embodiments of the present disclosure;

FIG. 5A is an enlarged partial schematic view of an insole according to one or more embodiments of the present disclosure, the insole being in a deflated condition;

FIG. 5B is an enlarged partial schematic view of an insole according to one or more embodiments of the present disclosure, the insole being in an inflated condition;

FIGS. 6A, 6B, 6C are top views of partial structures of insoles according to one or more embodiments of the specification, illustrating variations in void content in deflated and inflated states;

FIG. 7 is a block diagram of an inflation and deflation mechanism according to one or more embodiments of the present disclosure;

FIG. 8 is a schematic view of a bleed air adjustment valve of one or more embodiments of the present disclosure, the bleed air adjustment valve being in a closed state;

FIG. 9 is a schematic view of a bleed air adjustment valve of one or more embodiments of the present disclosure, the bleed air adjustment valve being in an open state;

FIG. 10 is a schematic flow diagram of a method of making one or more embodiments of the disclosure;

FIG. 11 is a schematic illustration of a process for making a solid insole model according to one or more embodiments of the present disclosure;

fig. 12A and 12B are schematic structural views of structural units according to one or more embodiments of the present disclosure.

Detailed Description

For the purpose of promoting a better understanding of the objects, aspects and advantages of the present disclosure, reference is made to the following detailed description taken in conjunction with the accompanying drawings.

It is to be noted that unless otherwise defined, technical or scientific terms used in one or more embodiments of the present specification should have the ordinary meaning as understood by those of ordinary skill in the art to which this disclosure belongs. The use of "first," "second," and similar terms in one or more embodiments of the specification is not intended to indicate any order, quantity, or importance, but rather is used to distinguish one element from another. The word "comprising" or "comprises", and the like, means that the element or item listed before the word covers the element or item listed after the word and its equivalents, but does not exclude other elements or items. The terms "connected" or "coupled" and the like are not restricted to physical or mechanical connections, but may include electrical connections, whether direct or indirect. "upper", "lower", "left", "right", and the like are used merely to indicate relative positional relationships, and when the absolute position of the object being described is changed, the relative positional relationships may also be changed accordingly.

As shown in fig. 1, 2, and 3, one or more embodiments of the present disclosure provide a porous variable stiffness diabetic foot pressure reduction insole comprising:

the body 10 is a reticular porous structure formed by connecting a plurality of small beams, and the small beams are hollow to form an air passage;

different adjusting areas are arranged on the body 10 corresponding to different pressure areas of the sole, the cross sections of air passages of the adjusting areas are the same or different, and the cross sections are the same or different in size;

during the gait cycle of the human body, the air inflation and deflation mechanism 20 can be used for inflating or deflating the air passage, and the rigidity and the air permeability of each adjusting area can be dynamically adjusted.

The porous rigidity-variable diabetic foot decompression insole provided by the embodiment comprises a body 10, wherein the body 10 is a net-shaped porous structure formed by mutually connecting a plurality of small beams, and the porous structure is provided with a plurality of air-permeable pores in each direction, so that the insole has air permeability; the trabeculae are hollow structures, and the hollow trabeculae which are connected with each other form an air passage; because the sole has pressure areas bearing different pressures, different adjusting areas are correspondingly arranged on the body 10 corresponding to different pressure areas of the sole, the different adjusting areas are realized by setting the sectional shape and the sectional shape size of the air passage, and the different adjusting areas have different rigidity and air permeability, so that proper mechanical property and air permeability can be provided for the corresponding pressure areas; in the asynchronous periodic process of the human body, the air charging and discharging mechanism 20 is used for charging or discharging air into the air passage, and the rigidity and the air permeability of each adjusting area of the insole can be dynamically adjusted by different air quantities in the air passage, so that the rehabilitation of the diabetic foot is facilitated.

In some embodiments, the cross-sectional shape and the size of the cross-sectional shape of the airway in each adjustment region are set according to the force characteristics of different pressure regions.

In the embodiment, different pressure areas of the sole have different stress characteristics, and according to the stress characteristics of the different pressure areas, the adjusting areas suitable for the pressure areas are obtained by setting the cross section shapes and the sizes of the cross section shapes of the air passages of the adjusting areas, so that the insoles with different rigidities in the different areas are obtained. In some embodiments, the force characteristic of the plantar pressure region may be the magnitude of the pressure applied to the pressure region, such as the forefoot region, the force characteristic of the plantar pressure region may be the magnitude of the torsional force applied to the pressure region, such as the arch region, and the force characteristic of the plantar pressure region may be both the magnitude of the compressive force and the magnitude of the torsional force, such as the heel region.

As shown in fig. 4A-4D, in some embodiments, the cross-sectional shape of the airway may be circular, elliptical, star-shaped, or rounded square; wherein, the round corner square is a square with four arc-shaped vertexes.

In this embodiment, the cross-sectional shape of the air passage may be circular, oval, star-shaped, or rounded square. Wherein, the small beam 131 with the cross section of the air passage in the shape of a circle 132A has isotropic mechanical property and better pressure resistance; the trabecula 131 with the oval 132B cross section of the air passage has anisotropic mechanical property and better torsion resistance; the trabecula 131 with the cross section of the air passage in the shape of a star 132D has anisotropic mechanical property, good pressure resistance and poor torsion resistance; the trabecula 131 with the section shape of the round-corner square 132C has isotropic mechanical property, and has better pressure resistance and torsion resistance.

In some embodiments, when the cross-sectional shape is circular, the size of the cross-section is the radius of the circle; when the cross section is in an elliptical shape, the size of the cross section is the major axis and the minor axis of the elliptical shape; when the cross section is in the shape of a round corner square, the size of the cross section is the side length of the round side square; when the cross-sectional shape is a star shape, the size of the cross-section is the diameter of the inscribed circle of the star shape.

In this embodiment, the sizes of the different cross-sectional shapes can be set, and by setting the different cross-sectional shapes and the sizes of the cross-sectional shapes, trabeculae and porous structures with different mechanical properties can be obtained, and the obtained adjustment area has different rigidities. In the specific design, the mechanical performance requirements and the air permeability requirements of different areas of the feet of different individuals can be determined according to the differences of the feet of the individuals, and on the basis, the shapes of the cross sections of the air passages and the specific sizes of the cross sections, which meet the mechanical performance requirements and the air permeability requirements, are set for the different areas of the body 10, so that the personalized foot wearing performance requirements are met.

In some embodiments, as shown in fig. 2 and 3, the sole 30 is divided into a first pressure region 31, a second pressure region 32, a third pressure region 33 and a fourth pressure region 34 according to the arrangement of the pressure borne by the different pressure regions of the sole from large to small, the body 10 is provided with a first adjustment region 11, a second adjustment region 12, a third adjustment region 13 and a fourth adjustment region 14 corresponding to the first pressure region 31, the second pressure region 32, the third pressure region 33 and the fourth pressure region 34, respectively, and the rigidity of the first adjustment region 11, the second adjustment region 12, the third adjustment region 13 and the fourth adjustment region 14 is arranged from small to large.

In this embodiment, a pressure test result is obtained by performing a pressure test on the foot, and according to the pressure test result, the pressure area of the sole can be divided into a first pressure area 31, a second pressure area 32, a third pressure area 33 and a fourth pressure area 34 according to the pressure applied to the sole from large to small, wherein the fourth pressure area 34 is an area other than the first, second and third pressure areas 31, 32 and 33; that is, the pressure experienced by the first pressure region 31 is the greatest, the pressure experienced by the second pressure region 32 is the next greatest, and the pressure experienced by the fourth pressure region is the smallest.

For the purpose of pressure reduction, correspondingly, a first adjusting area 11 is arranged on the body 10 of the insole corresponding to the first pressure area 31, and the rigidity of the first adjusting area 11 is minimum, so that the first pressure area 31 can be subjected to pressure reduction; a second conditioning zone 12 is provided corresponding to the second pressure zone 32, the second conditioning zone 12 being less rigid and capable of depressurizing the second pressure zone 32; a third regulating area 13 is arranged corresponding to the third pressure area 33, the rigidity of the third regulating area 13 is small, and the third pressure area 33 can be decompressed; by providing the fourth adjustment region 14 in correspondence with the fourth pressure region 34, the stiffness of the fourth adjustment region 14 is minimized, enabling decompression of the fourth pressure region 34 and providing good comfort.

In some embodiments, the cross-sectional shape of the airway of first modulation region 11 is star-shaped, the cross-sectional shape of the airway of second modulation region 12 is circular, the cross-sectional shape of the airway of third modulation region 13 is oval, and the cross-sectional shape of the airway of fourth modulation region 14 is rounded square. In some modes, the section size range of the air passage of the trabecula in each adjusting area is 1-4 mm, the section size of the air passage is smaller than that of the trabecula, and the specific value of the section size of the air passage of the trabecula in each adjusting area is determined according to the sole pressure condition of an individual in combination with the insole manufacturing process.

In this embodiment, for the purpose of reducing the pressure in the first pressure area 31, the cross-sectional shape of the air passage of the first adjustment area 11 may be provided as a star shape having good pressure resistance, and in combination with the size of the star shape, provides a suitable stiffness for the first pressure area 31. The cross-sectional shape of the airway of the second modulation region 12 may be configured as a circle having a relatively good resistance to pressure, and in combination with the size of the circle, provide suitable stiffness for the second pressure region 32. The cross-sectional shape of the air passage of the third regulation region 13 may be configured as an ellipse with good resistance to torsion, and in combination with the size of the ellipse, provides a suitable stiffness for the third pressure region 33. The cross-sectional shape of the airway of the fourth modulation region 14 may be configured as a rounded square, in combination with the size of the rounded square, to provide suitable stiffness for the fourth pressure region 34.

In some embodiments, as shown in fig. 1, the body 10 is provided with a first contact area in contact with the forefoot and a second contact area in contact with the arch, the porous structure of the first contact area having a first porosity and the porous structure of the second contact area having a second porosity, the first porosity being greater than the second porosity, according to different contact areas corresponding to the sole of the foot. That is, the area of the insole corresponding to the forefoot has a large porosity, so that the first contact area corresponding to the forefoot has good air permeability, and the area of the insole corresponding to the arch portion has a small porosity and a large rigidity, so that good mechanical support can be provided for the arch portion. Therefore, different porosities are designed in different areas of the insole, variable-rigidity mechanical stimulation can be provided for feet, and the insole has the functions of assisting massage and rehabilitation and changing the mechanical environment, the blood flow state and microcirculation of local areas.

In some embodiments, the pore density of the different areas is set according to the biomechanical characteristics of different parts of the foot and the wearing performance requirement, and this embodiment is not limited in particular. In the actual design process, the smaller the porosity, the higher the rigidity of the insole, the higher the supporting force, and the lower the air permeability, the closer to the solid insole; the higher the porosity, the lower the rigidity of the insole, the lower the supporting force and the better the air permeability. In the embodiment, different porosity is set in different areas of the insole, so that the insole can provide adaptive mechanical properties and air permeability for different parts of the foot.

As shown in fig. 5A, 5B, 6A, 6B, and 6C, the body 10 is formed by connecting a plurality of small beams 131 to each other to form a net-shaped porous structure, pores 14 allowing air to pass are formed between the small beams 131, and the small beams 131 are hollow to form air passages. As shown in fig. 5A and 6A, in the deflated state, a small amount of air is in the air passage, the pores 14 are large, the rigidity of the insole is small, the air permeability is good, and the insole is suitable for the situation that the foot is in a non-load position; as shown in fig. 5B, 6B and 6C, during inflation, the gas in the air passage increases, the trabecula 131 gradually becomes thicker and thicker, the pores 14 gradually become smaller, the porosity of the insole decreases, the rigidity increases, and good supporting force can be provided for the foot in the weight bearing position to support the larger weight of the human body. Therefore, the rigidity and the air permeability of the insole can be adjusted by inflating and deflating the air passage of the insole.

Referring to fig. 1 and 7, in some embodiments, the airway has an inflation port 11 and a deflation port 12; the inflation and deflation mechanism 20 comprises an inflation unit, a pressure detection unit, a control unit and a deflation regulating valve 21, wherein the inflation end of the inflation unit is connected with the inflation port 11, and the deflation regulating valve 21 is connected with the deflation port 12;

when the pressure detection unit detects that the foot pressure reaches a preset load pressure threshold value, the control unit controls the inflation unit to inflate the air passage, the deflation regulating valve 21 closes the deflation port 12, the rigidity of the insole is increased, the mechanical bearing capacity is improved, and the air permeability is reduced; when the pressure detection unit detects that the foot pressure is less than or equal to the preset non-load pressure threshold value, the deflation regulating valve opens the deflation port 12, the rigidity of the insole is reduced, and the air permeability is increased.

In this embodiment, in order to realize inflation and deflation of the air passage, the air passage is provided with an inflation port 11 and a deflation port 12, in the human gait cycle process, the pressure detection unit is used for detecting the load pressure signal of the foot in real time, and transmitting the detected load pressure signal to the control unit, the control unit receives the load pressure signal, and judges whether the current foot pressure reaches the load pressure threshold value or not according to the load pressure signal, when the foot pressure reaches the load pressure threshold value, the control unit controls the inflation unit to work, the inflation unit is used for inflating the air passage, meanwhile, the deflation regulating valve 21 seals the deflation port 12, at this time, the air passage is in an inflation state, in the inflation process, the rigidity of the insole is increased, the air permeability is reduced, and the insole in the inflation state can provide supporting force for.

When the control unit judges that the current foot pressure is less than or equal to the non-load pressure threshold value according to the load pressure signal, the inflation unit does not work and does not inflate the air passage, meanwhile, the dynamic adjusting valve 21 opens the air release port, the air passage is in an air release state, in the air release process, the rigidity of the insole is reduced, the air permeability is increased, and the insole in the air release state can provide good air permeability.

When the control unit judges that the current foot pressure is larger than the non-load pressure threshold value and smaller than the load pressure threshold value according to the load pressure signal, the inflation unit does not work and does not inflate the air channel, meanwhile, the dynamic adjusting valve 21 seals the air release port, and the amount of the air in the air channel is kept unchanged.

In some application scenes, by combining a human body gait cycle schematic diagram, when the hindfoot is in contact with the ground and the forefoot is not in contact with the ground, the foot pressure reaches a loading pressure threshold value, and the insole is in an inflated state to provide weight support for a human body; when the front foot is contacted with the ground and the rear foot is not contacted with the ground, the pressure of the foot is less than or equal to the non-load bearing pressure threshold value, and the insole is in a deflation state, so that the air permeability is improved, and the rigidity is reduced; when the front foot and the rear foot are both contacted with the ground, the amount of gas in the air passage of the insole is unchanged, and the current rigidity and ventilation state are maintained. In the gait cycle of the human body, the reciprocating circulation can improve the temperature and humidity environment in the shoes of the diabetic patients, thereby being beneficial to the prevention and the rehabilitation of the diabetic feet.

In some embodiments, deflation control valve 21 comprises a connected switch portion and a resilient member; when the pressure of the foot reaches the loading pressure threshold value, the elastic piece is compressed and deformed, the switch part is closed to close the air release opening, and when the pressure of the foot is smaller than or equal to the non-loading pressure threshold value, the switch part is opened to open the air release opening under the action of the elastic restoring force of the elastic piece.

In this embodiment, the deflation regulating valve 21 comprises a switch part and an elastic member which are connected, when the foot pressure reaches the load pressure threshold value in the human gait cycle, the switch part and the elastic member are pressed down by the foot pressure, the elastic member is compressed and deformed, and the switch part is closed to seal the deflation port 12; when the pressure of the foot is less than or equal to the non-load pressure threshold value, the elastic restoring force of the elastic piece pushes the switch part to rise, the switch part is opened, the air release port 12 is opened, and the air in the air channel is discharged through the air release port 12.

Referring to fig. 8 and 9, in some embodiments, the switching portion includes a first plate 211 and a second plate 212 overlapping each other, the elastic member includes a first elastic member 213 and a second elastic member 214, the first plate 211 is connected to the first elastic member 213, and the second plate 212 is connected to the second elastic member 214;

when the foot pressure reaches the weight-bearing pressure threshold value, the first elastic member 213 and the second elastic member 214 are compressed and deformed, and the first sheet 211 and the second sheet 212 are closed to close the air release opening 12; when the foot pressure is equal to or less than the non-weight-bearing pressure threshold value, the first sheet 211 and the second sheet 212 are opened by the elastic restoring force of the first elastic member 213 and the second elastic member 214, and the air release opening 12 is opened.

In this embodiment, the opening and closing portion of the deflation control valve 21 comprises a first sheet body 211 and a first elastic member 213 which are connected with each other, a second sheet body 212 and a second elastic member 214 which are connected with each other, and the first sheet body 211 is overlapped on the second sheet body 212; when the first sheet body 211 and the second sheet body 212 are pressed down by foot pressure, the lap joint 215 of the first sheet body 211 and the second sheet body 212 is closed, that is, the switch part is closed, and the first elastic member 213 and the second elastic member 214 are deformed by the downward pressure; in the process of gradually reducing the foot pressure, the elastic restoring forces of the two elastic members 213 and 214 respectively push the two sheet bodies 211 and 212 upwards until the foot pressure is less than or equal to the non-load pressure threshold value, the overlapping port 215 of the first sheet body 211 and the second sheet body 212 is opened, that is, the switch part is opened, and the deflation port 12 starts to deflate.

In some ways, the inflation port 11 of the air channel can be disposed in the heel area (the area contacting with the heel of the human body) of the body 10 or other areas, and the arrangement position can be set according to the positions of the inflation unit and the control unit, and the specific arrangement position is not limited. The deflation port 12 of the air passage can be arranged in the heel area of the body 10, the pressure detection unit can select the pressure sensor for use, the pressure sensor is arranged in the heel area of the body 10, and the pressure sensor can also be arranged on the first sheet body 211 of the deflation regulating valve 21, so that the deflation regulation can be carried out according to the foot load pressure, and the specific setting position is not limited. The control unit may be a main control chip having a data processing function, and the type and model of the main control chip are not particularly limited. The inflation unit can be a miniature inflation device such as a miniature air pump which can realize an inflation function, and the type and the model of the miniature air pump are not specifically limited.

On one hand, the porous variable-stiffness diabetic foot pressure reduction insole provided by the embodiment of the specification is provided with different adjusting areas corresponding to different pressure areas of a foot, and the different adjusting areas are utilized to provide proper stiffness for the corresponding pressure areas so as to realize weight reduction; in the second aspect, in the gait cycle process of a human body, the air inflation and deflation mechanism is utilized to inflate the air passage of the insole or discharge the air in the air passage, so that the insole can adapt to the load position or the non-load position of the foot, the dynamic adjustment of rigidity and air permeability is realized, and the requirements of the air permeability and mechanical property of the foot at different positions and different dynamic stages are met; in the third aspect, the insole is provided with different porosities corresponding to the areas of different parts of the foot, so that the air permeability and the rigidity of different parts can be adjusted, and the requirements of different parts of the foot of different patients on the air permeability and the mechanical property are met; in the fourth aspect, the cross-sectional shapes and sizes of the air passages in different adjusting areas and the porosities in different areas can be set according to the individual foot conditions, so that the individual design of different patients can be met. From the aspects, the insole of the embodiment can improve the local pressure and blood circulation of the diabetic foot by providing the stimulation of rigidity change to the foot, can provide the variable porosity, can improve the micro-environments such as the local temperature and humidity of the diabetic foot, and further promotes the rehabilitation of the patient.

One or more embodiments of the present specification also provide a shoe including the insole as described above, the body 10 of which is placed inside the shoe, and in some ways, the inflation unit and the control unit may be provided in the cavity of the heel of the sole. When a patient wears the shoe, different adjusting areas of the insole can provide variable rigidity and air permeability, and the pressure reduction adjustment and the air permeability adjustment are carried out on different pressure areas of the sole; in the gait adjusting process, the rigidity and the air permeability can be dynamically adjusted, and the adaptive air permeability and mechanical property are provided for the feet.

As shown in fig. 10, one or more embodiments of the present disclosure also provide a method for manufacturing a porous variable stiffness diabetic foot decompression insole, comprising:

s101: acquiring foot muscle and bone data of a foot of a patient;

s102: reconstructing a three-dimensional model of the foot musculoskeletal of the foot of the patient according to the data of the foot musculoskeletal;

in this embodiment, the foot musculoskeletal data of the patient may be acquired through a CT or MRI scanning technology, and the foot musculoskeletal data is processed by using three-dimensional reconstruction software (e.g., mics software), inner contours of foot bones and muscles are extracted layer by layer, and the extracted inner contours are fitted to generate a musculoskeletal integrated foot musculoskeletal three-dimensional model.

S103: generating a solid insole model which is completely fit with the foot bottom shape of the foot of the patient according to the three-dimensional model of the foot musculoskeletal;

as shown in fig. 11, in the present embodiment, based on the generated three-dimensional model of the musculoskeletal structure of the foot, a solid insole completely fitting the shape of the sole of the foot is preliminarily designed by means of three-dimensional design software (for example, software such as Sildworks, UG, or Pro/e) through methods such as fitting surface cutting and boolean operations.

Among other ways, a soft material (e.g., plasticine) can also be used to obtain the foot mold in a foot-stepping manner; and then, scanning the foot model by using a reverse scanning technology to obtain the foot form of the foot of the patient, generating a three-dimensional model of the musculoskeletal structure of the foot by using three-dimensional reconstruction software, and processing by using three-dimensional design software based on the three-dimensional model of the musculoskeletal structure of the foot to design the solid insole. The specific method and process for designing a solid insole is not particularly limited.

S104: obtaining a plantar pressure test result of a foot of a patient;

s105: determining different pressure areas of the foot of the patient according to the sole pressure test result;

s106: setting different adjusting areas on the solid insole model according to different pressure areas;

in this embodiment, the pressure measuring instrument may be used to measure the plantar pressure of the foot of the patient to obtain a plantar pressure test result, and based on the plantar pressure test result, different pressure regions of the foot bearing different pressure ranges are divided. In order to realize the purpose of adjusting different pressure areas, different adjusting areas corresponding to the pressure areas are arranged on the solid insole model, and the pressure and air permeability of the pressure areas are adjusted by utilizing the adjusting areas.

S107: according to different adjusting areas, building a structural body unit of each adjusting area; the structural body unit is a structure with holes and formed by a plurality of small beams, and the small beams are hollow to form air passages;

s108: and splicing the structural body units of each adjusting area by using a modeling method to obtain the insole model with a net-shaped porous structure.

In this embodiment, after each adjustment area on the solid insole model is determined, the structural units corresponding to each adjustment area are created, and then the structural units of each adjustment area are spliced by using a modeling method, so as to obtain the insole model with the mesh-like porous structure.

The method for preparing the porous variable-stiffness pressure-reducing insole for the diabetic foot, provided by the embodiment, includes the steps of obtaining foot musculoskeletal data of a foot of a patient, reconstructing a three-dimensional foot musculoskeletal model of the foot of the patient according to the foot musculoskeletal data, generating a solid insole model completely fitting with a foot bottom shape of the foot of the patient according to the three-dimensional foot musculoskeletal model, obtaining a foot bottom pressure test result of the foot of the patient, determining different pressure areas of the foot of the patient according to the foot bottom pressure test result, setting different adjusting areas on the solid insole model according to the different pressure areas, creating structural units of the adjusting areas according to the different adjusting areas, and splicing the structural units of the adjusting areas by a modeling method to obtain the insole model with a net-shaped. By utilizing the preparation method of the embodiment, the insole which has a porous structure and can realize the regulation function can be prepared, and the insole has variable rigidity and air permeability and is beneficial to the recovery of diabetic feet.

In some embodiments, as shown in fig. 12A and 12B, the porous structure is formed by splicing a plurality of structural units by using a modeling method. As shown in fig. 12A, the structural unit may be a dodecahedron rod structural unit, the dodecahedron rod structural unit includes a rhombic dodecahedron formed by twenty-four small beams 131A, and small beams 131A' respectively extending outwards from two opposite vertexes of the dodecahedron of the rhombic dodecahedron, pores are formed between the adjacent small beams, and the dodecahedron rod structural unit is formed with a plurality of pores distributed in a three-dimensional space. As shown in fig. 12B, the structural unit may be an octahedral rod structural unit, which includes an octahedron composed of twelve small beams 131B and eight triangular pyramids respectively composed of eight faces of the octahedron as a bottom face and six vertexes of the octahedron extending outward to form small beams 131B', and pores are formed between adjacent small beams, and the octahedral structural unit is formed with a plurality of pores distributed in a three-dimensional space.

In some embodiments, creating a building block for each adjustment zone based on a different adjustment zone includes:

the cross-sectional shape and the size of the cross-sectional shape of the gas passage of the structural unit are set according to the different adjustment regions.

In the present embodiment, a dodecahedron rod structure unit or an octahedron rod structure unit may be used as the structure unit, and the sectional shape and the size of the sectional shape of the air passage of the trabecula are set based on the selected structure unit. For example, a dodecahedron rod structural unit is selected as a basic structural unit, and for the first adjustment region 11, the cross-sectional shape of the air passage of the trabeculae provided with the dodecahedron rod structural unit is a star shape, and the diameter of the inscribed circle of the star shape is set to be a first numerical value; for the second adjustment region 12, the cross-sectional shape of the air passage of the trabeculae provided with the dodecahedron pole structural unit is circular, and the diameter of the circle is set to a second numerical value; for the third adjustment region 13, the cross-sectional shape of the air passage of the trabeculae provided with the dodecahedron rod structural unit is an ellipse, the major axis of the ellipse is set to be a third numerical value, and the minor axis is set to be a fourth numerical value; for the fourth adjustment area 14, the cross-sectional shape of the air passage of the trabeculae provided with the dodecahedron bar structural unit is a rounded square, and the side length of the rounded square is a fifth numerical value.

In some embodiments, before setting the cross-sectional shape and the size of the cross-sectional shape of the air passage of the structural unit according to different adjustment regions, the method further includes:

selecting structural units according to different adjusting areas, and determining the shape parameters of the structural units; the form parameter includes the cross-sectional dimension of the spar.

In this embodiment, when the structural units of each adjustment area are created according to different adjustment areas, a suitable structural unit is selected first, in some modes, each adjustment area of the insole can be selected from the same structural unit or different structural units, the determination is made according to specific conditions of the foot, one structural unit can be selected first, and another structural unit is selected again in the optimization process of the insole model. After each adjusting region selects and determines a proper structural unit, further determining the shape parameters of the structural unit, that is, the sectional size of the trabecula of the structural unit, and setting the sectional size of the trabecula according to the stress characteristics of different adjusting regions, for example, the pressure applied to the first pressure region 31 is larger, the sectional size of the trabecula of the first adjusting region 11 can be larger, the setting of the sectional size of the trabecula of each adjusting region is determined according to the sole pressure condition of an individual in combination with the insole manufacturing process, which is not specifically limited in this embodiment.

In some modes, the section shape of the trabecula can be square, regular triangle, circle or ellipse, and when the section shape of the trabecula is square, the section size of the trabecula is the side length of the square; when the section of the small beam is in the shape of a regular triangle, the section size of the small beam is the side length of the regular triangle; when the section of the small beam is circular, the section of the small beam is circular in diameter; when the sectional shape of the trabecula is an ellipse, the sectional dimensions of the trabecula are the major axis and the minor axis of the ellipse. The present embodiment is merely an exemplary illustration, and is not limited in particular.

In some embodiments, the method for making a porous variable stiffness diabetic foot decompression insole further comprises:

carrying out mechanical property test on the insole model to obtain a performance test result;

adjusting the structural body unit of each adjusting area according to the performance test result;

and splicing the adjusted structural body units of each adjusting area by using a modeling method to obtain an optimized insole model.

In this embodiment, after the insole model is obtained by design, the insole model is further subjected to a simulation analysis test of mechanical properties. For example, through simulation analysis, the mechanical properties of the insole model are quantitatively tested by taking parameters such as stress, strain, displacement and the like as measurement indexes, particularly different adjustment areas on the insole model are quantitatively tested to obtain corresponding quantitative indexes, the cross section shape and the size of the cross section shape of the air passage are readjusted according to the quantitative indexes, and the structural body unit and the body parameters thereof can be adjusted, so that the optimized and adjusted insole model can meet the purpose of pressure reduction adjustment of different pressure areas. Through simulation analysis, parameters such as permeability, flow velocity, fluid shearing force and the like can be used as measurement indexes to carry out quantitative test on the air fluid performance of the insole model to obtain corresponding quantitative indexes, the density of the structural body units in different areas is readjusted according to the quantitative indexes, and the pore density in different areas is adjusted, so that the optimized and adjusted insole model can have good air permeability.

In some embodiments, the method for making a porous variable stiffness diabetic foot decompression insole further comprises: and manufacturing the insole by using a three-dimensional printing technology based on the optimized insole model. Namely, after the shoe pad model after optimization and adjustment is designed, the shoe pad can be printed by using a three-dimensional printing technology, and the shoe pad is manufactured.

Those of ordinary skill in the art will understand that: the discussion of any embodiment above is meant to be exemplary only, and is not intended to intimate that the scope of the disclosure, including the claims, is limited to these examples; within the spirit of the present disclosure, features from the above embodiments or from different embodiments may also be combined, steps may be implemented in any order, and there are many other variations of different aspects of one or more embodiments of the present description as described above, which are not provided in detail for the sake of brevity.

In addition, well-known power/ground connections to Integrated Circuit (IC) chips and other components may or may not be shown in the provided figures, for simplicity of illustration and discussion, and so as not to obscure one or more embodiments of the disclosure. Furthermore, devices may be shown in block diagram form in order to avoid obscuring the understanding of one or more embodiments of the present description, and this also takes into account the fact that specifics with respect to implementation of such block diagram devices are highly dependent upon the platform within which the one or more embodiments of the present description are to be implemented (i.e., specifics should be well within purview of one skilled in the art). Where specific details (e.g., circuits) are set forth in order to describe example embodiments of the disclosure, it should be apparent to one skilled in the art that one or more embodiments of the disclosure can be practiced without, or with variation of, these specific details. Accordingly, the description is to be regarded as illustrative instead of restrictive.

While the present disclosure has been described in conjunction with specific embodiments thereof, many alternatives, modifications, and variations of these embodiments will be apparent to those of ordinary skill in the art in light of the foregoing description. For example, other memory architectures (e.g., dynamic ram (dram)) may use the discussed embodiments.

It is intended that the one or more embodiments of the present specification embrace all such alternatives, modifications and variations as fall within the broad scope of the appended claims. Therefore, any omissions, modifications, substitutions, improvements, and the like that may be made without departing from the spirit and principles of one or more embodiments of the present disclosure are intended to be included within the scope of the present disclosure.