3D printing insole for hallux valgus correction and manufacturing method

Abstract

The invention relates to the technical field of foot correction, and discloses a 3D printing insole for hallux valgus correction and a manufacturing method.The insole comprises an insole body, a first elastic band, a second elastic band, a first connecting part, a second connecting part, a third connecting part and a fourth connecting part, and the insole body is provided with a concave structure used for being attached to the thumb; after the first connecting part is connected with the third connecting part, the first elastic band can apply an inward acting force to the hallux; after the second connecting part is connected with the fourth connecting part, the second elastic band can apply outward acting force to the first metatarsal bone, the angles of the hallux and the first metatarsal bone are effectively controlled, the hallux valgus condition is improved, the transition flexibility of the first metatarsal joint is improved, the foot structure is improved, and the hallux valgus symptom is relieved.

Description

Technical Field

[0001] The present invention relates to the technical field of foot correction, and in particular to a 3D printed insole for hallux valgus correction and a manufacturing method thereof. Background Art

[0002] HV (Hallux Valgus), also known as hallux valgus, is a common foot deformity. The main manifestations of hallux valgus are hallux valgus and first metatarsal varus. Specifically, hallux valgus refers to the inclination of the joint between the hallux and the first metatarsal exceeding 15°. Among them, the inclination angle between the hallux and the first metatarsal is between 15° and 30°, which is mild hallux valgus; the inclination angle between the hallux and the first metatarsal is between 30° and 40°, which is moderate hallux valgus; the inclination angle between the hallux and the first metatarsal is greater than 40°, which is severe hallux valgus. Hallux valgus not only affects the appearance of the foot, but is also usually accompanied by symptoms such as pain, swelling, and limited mobility. It may lead to complications such as arthritis and metatarsal deformity. In severe cases, it may even affect the quality of daily life. Global epidemiological data show that the total prevalence of hallux valgus is about 19%, and the prevalence of women is significantly higher than that of men, about 23.74%. This difference is closely related to factors such as women wearing high heels for a long time and improper shoe design.

[0003] In the prior art, orthopedic insoles for alleviating hallux valgus symptoms mainly include conventional corrective insoles, customized insoles, and some special orthopedic insoles, which generally relieve symptoms by dispersing the pressure on the sole of the foot, adjusting the gait, or providing additional support. Currently, most orthopedic insoles are designed to alleviate hallux valgus symptoms by changing the pressure distribution on the sole of the foot or by providing physical support.

[0004] The design of orthopedic insoles in the prior art does not fully consider the pathological mechanism of hallux valgus, and has the following limitations: ① Lack of targeted personalized design: Most existing insoles adopt standardized design, and fail to make personalized adjustments according to the foot morphology and severity of hallux valgus of different patients, resulting in large differences in treatment effects; ② Poor comfort: Most existing orthopedic insoles use hard or semi-hard materials, which are not comfortable. Long-term wearing can easily cause discomfort and aggravate the symptoms; ③ Difficult to correct fundamentally: Although existing orthopedic insoles can relieve the symptoms of hallux valgus, they usually improve the pressure distribution of the foot within a limited range and cannot effectively correct changes in the foot structure. The corrective effect of existing orthopedic insoles is limited. Summary of the invention

[0005] In view of the above-mentioned deficiencies or defects in the prior art, the present invention provides a 3D printed insole for hallux valgus correction, which not only provides an inversion force to the big toe and improves the hallux valgus condition, but also provides dynamic support and stability to the first metatarsal, improves the excessive flexibility of the first metatarsocuneiform joint, and thus improves the foot structure.

[0006] In order to achieve the above object, the present invention provides a 3D printed insole for hallux valgus correction, comprising:

[0007] An insole body, which is manufactured by 3D printing technology and has a concave structure for fitting the thumb;

[0008] A first elastic band, wherein one end of the first elastic band is fixedly connected to the insole body, and the other end of the first elastic band has a first connecting portion;

[0009] A second elastic band, wherein one end of the second elastic band is fixedly connected to the insole body and the other end of the second elastic band has a second connecting portion;

[0010] a third connecting portion, the third connecting portion being fixedly disposed on the insole body and being capable of being fixedly connected to the first connecting portion;

[0011] a fourth connecting portion, the fourth connecting portion being fixedly disposed on the insole body and being capable of being fixedly connected to the second connecting portion;

[0012] Wherein, the position where the first elastic band and the insole body are fixedly connected is located outside the recessed structure; after the first connecting portion is connected to the third connecting portion, the first elastic band can exert an inward force on the big toe; after the second connecting portion is connected to the fourth connecting portion, the second elastic band can exert an outward force on the first metatarsal.

[0013] In some embodiments, the distance between the position where the first elastic band and the insole body are fixedly connected and the outer edge of the recessed structure is d, and satisfies: d=f(θ) and θ=g(θ0); wherein θ0 is the hallux valgus angle and 15°≤θ0≤40°; g(θ0) is the value function of θ0; θ is the value obtained after calculating the g(θ0) function; and f(θ) is a positive correlation function of θ.

[0014] In some embodiments, g(θ0)=360*(θ0 / 360°), f(θ)=1+0.03θ; wherein d is in centimeters.

[0015] In some embodiments, f(θ)=1+0.03θ; wherein d is in centimeters.

[0016] In some embodiments, when 15°≤θ0<30°, the length*width*depth dimensions of the recessed structure are 3.5cm*2cm*5mm; when 30°≤θ0≤40°, the length*width*depth dimensions of the recessed structure are 4.5cm*2.5cm*7mm; wherein, the length, width and depth directions of the recessed structure are perpendicular to each other, the length direction of the recessed structure is consistent with the inner and outer sides of the insole body, the width direction of the recessed structure is perpendicular to the length direction of the recessed structure, and the depth direction of the recessed structure is perpendicular to the surface of the insole body.

[0017] In some embodiments, after the first connection portion on the first elastic band is connected to the third connection portion, the force applied by the first elastic band to the big toe is F1, wherein: 5N≤F1≤10N; after the second connection portion on the second elastic band is connected to the fourth connection portion, the force applied by the second elastic band to the first metatarsal is F2, wherein: 10N≤F2≤20N.

[0018] In some embodiments, the first elastic band and / or the second elastic band has a width of W and a thickness of T, wherein: 3 cm ≤ W ≤ 5 cm; 0.1 cm ≤ T ≤ 0.5 cm.

[0019] In some embodiments, the first connection part and the third connection part are connected by Velcro; and / or the second connection part and the fourth connection part are connected by Velcro.

[0020] In some embodiments, after the first connection portion is connected to the third connection portion and after the second connection portion is connected to the fourth connection portion, at least the following conditions are satisfied: when the insole is worn, the direction of the force applied by the first elastic band to the big toe is perpendicular to the long axis of the big toe; the point of action of the second elastic band on the first metatarsal bone is located at the first metatarsal cuneiform joint and the direction of the force is the first direction, the direction in which the insole body extends from the heel to the toe is the second direction, and the angle between the first direction and the second direction is α, wherein: 45°≤α≤60°.

[0021] The present invention also provides a method for manufacturing the 3D printed insole for hallux valgus correction as described above, comprising the following manufacturing steps:

[0022] S1: obtaining foot data date1 of the patient in the current state, which at least includes the hallux valgus angle and the foot shape contour, and determining the hallux valgus level of the patient according to the hallux valgus angle θ0;

[0023] If: θ0<15°, it is determined that there is no hallux valgus, and step S11 is performed;

[0024] If: 15°≤θ0<30°, it is determined to be mild hallux valgus, and step S2 is performed;

[0025] If: 30°≤θ0<40°, it is determined to be moderate hallux valgus, and step S2 is performed;

[0026] If: θ0≥40°, it is determined to be severe hallux valgus, and step S2 is performed;

[0027] S2: Obtain patient identity information and match the patient identity information with the information database;

[0028] If: the match is successful, and the patient's hallux valgus level is severe hallux valgus, proceed to step S11;

[0029] If: the match is successful, and the patient's hallux valgus level is mild hallux valgus or moderate hallux valgus, then retrieve the patient's information data file t0 from the information database and proceed to step S8;

[0030] If the match is not successful, an information data file t1 matching the patient's identity information is created, and the information data file t1 is included in the information database, and step S3 is performed;

[0031] S3: According to the foot data date1 of the patient in the current state, simulate the normal state of the patient's foot and obtain the foot data date2 of the patient in the normal state, determine the main contour data date3 of the insole of the patient's foot in the normal state based on the foot data date2 of the patient in the normal state, enter date2 and date3 into the information data file t1, and proceed to step S4;

[0032] S4: If the hallux valgus level of the patient's foot is currently severe hallux valgus, proceed to step S11;

[0033] If the hallux valgus level of the patient's foot in the current state is mild hallux valgus or moderate hallux valgus, proceed to step S5;

[0034] S5: according to the foot data date1 of the patient in the current state, calculate and obtain the position data of the concave structure on the insole body and the size data date4 of the concave structure, the fixed position data date5 of the first elastic band and the insole body, and the fixed position data date6 of the second elastic band and the insole body, and proceed to step S6;

[0035] S6: According to date3 and date4, the insole body and the concave structure on the insole body are manufactured by 3D printing technology, and then the first elastic band and the second elastic band are fixed to the insole body according to date5 and date6, and step S7 is performed;

[0036] S7: a first connection portion is provided on an end of the first elastic band away from the insole body, a second connection portion is provided on an end of the second elastic band away from the insole body, a third connection portion and a fourth connection portion are provided on the insole body, and step S11 is performed;

[0037] S8: Read the patient's foot data date2 in a normal state and the insole body contour data date3 in a normal state in the information data file t0, and calculate the position data of the concave structure on the insole body and the size data date4 of the concave structure, the first elastic band and the insole body fixed position data date5, and the second elastic band and the insole body fixed position data date6 according to the patient's foot data date1 in the current state, and proceed to step S9;

[0038] S9: According to date 3 and date 4, the insole body and the concave structure on the insole body are manufactured by 3D printing technology, and then the first elastic band and the second elastic band are fixed to the insole body according to date 5 and date 6, and step S10 is performed;

[0039] S10: a first connection portion is provided on an end of the first elastic band away from the insole body, a second connection portion is provided on an end of the second elastic band away from the insole body, a third connection portion and a fourth connection portion are provided on the insole body, and step S11 is performed;

[0040] S11: End.

[0041] A 3D printed insole for hallux valgus correction using the above technical solution of the present invention has the following effects: a first elastic band and a second elastic band are arranged on the insole main body, and after the first connecting portion on the first elastic band and the third connecting portion on the insole main body are fixedly connected, the first elastic band can provide an inversion force to the patient's big toe, and after the second connecting portion on the second elastic band and the fourth connecting portion on the insole main body are fixedly connected, the second elastic band can apply an eversion force to the first metatarsal, so that the first metatarsocuneiform joint between the first metatarsal and the medial cuneiform is no longer overly flexible, thereby effectively controlling the angles of the big toe and the first metatarsal, improving the foot structure, and alleviating the symptoms of hallux valgus.

[0042] Other features and advantages of the present invention will be described in detail in the following detailed description. BRIEF DESCRIPTION OF THE DRAWINGS

[0043] Figure 1 is a top view schematic diagram of a 3D printed insole for hallux valgus correction according to an embodiment of the present invention;

[0044] Figure 2 is a bottom view schematic diagram of a 3D printed insole for hallux valgus correction according to an embodiment of the present invention;

[0045] Figure 3 is a schematic top view of an insole body according to an embodiment of the present invention;

[0046] Figure 4 is a side view schematic cross-sectional view of a recessed structure according to an embodiment of the present invention;

[0047] Figure 5 It is a schematic flow chart of a method for making a 3D printed insole for hallux valgus correction according to an embodiment of the present invention, wherein: block diagram A is an integrated flow chart of steps after unsuccessful matching in step S2, and block diagram B is an integrated flow chart of steps after successful matching in step S2;

[0048] Figure 6 It is a schematic diagram of the process after the block diagram A is expanded;

[0049] Figure 7 It is a flowchart diagram of the process after the block diagram B is expanded.

[0050] Description of Reference Numerals

[0051] 1. Insole body; 2. First elastic band; 3. Second elastic band; 4. First connecting part; 5. Second connecting part; 6. Third connecting part; 7. Fourth connecting part; 8. Concave structure. DETAILED DESCRIPTION

[0052] The specific embodiments of the present invention are described in detail below. It should be understood that the specific embodiments described herein are only used to illustrate and explain the present invention, and are not used to limit the present invention.

[0053] In the present invention, unless otherwise stated, the directional words such as "upper" and "lower" usually refer to the orientation in the assembled state. "Inside" and "outside" refer to the inside and outside relative to the outline of each component itself.

[0054] The present invention provides a 3D printed insole for hallux valgus correction, which provides stable dynamic adjustment for the first metatarsal and the big toe. The essence of hallux valgus is the inversion of the first metatarsal and the valgus of the big toe, which eventually leads to structural abnormalities of the foot. If the stability of the first metatarsal area is not effectively guaranteed, the correction effect will be limited. Therefore, simply relying on the improvement of foot pressure distribution by the insole cannot fundamentally change the occurrence or progression of foot deformities.

[0055] First of all, it should be noted that severe hallux valgus generally requires surgical treatment, so the insole of the present invention is suitable for patients with mild hallux valgus or moderate hallux valgus. In some embodiments of the present invention, when the hallux valgus angle is less than 15°, it is determined to be no hallux valgus; when the hallux valgus angle is 15° to 30°, it is determined to be mild hallux valgus; when the hallux valgus angle is 30° to 40°, it is determined to be moderate hallux valgus; when the hallux valgus angle is greater than 40°, it is severe hallux valgus. And the hallux valgus angle equal to 15° is classified as mild hallux valgus level. The hallux valgus angle equal to 30° and the hallux valgus angle equal to 40° are classified as moderate hallux valgus level. In other embodiments, the level of hallux valgus and the corresponding hallux valgus angle can be divided accordingly according to needs.

[0056] Specifically, the insole comprises an insole body 1, a first elastic band 2, a second elastic band 3, a first connecting portion 4, a second connecting portion 5, a third connecting portion 6 and a fourth connecting portion 7. The insole body 1 has a concave structure 8 for fitting the thumb. Figure 1 , Attachment Figure 2 , the insole is for the right foot. The insole body 1 is manufactured by 3D printing technology, and can be accurately designed according to the patient's foot morphology, foot parameters (such as arch, foot shape, hallux valgus angle, etc.) and specific condition, so that the size and contour of the insole can better fit the patient's foot, cover key areas of the foot (such as arch, first metatarsal, outer side of the big toe, etc.), provide necessary support and pressure distribution, and reasonably design the curvature, thickness and edge of the insole to ensure that the insole provides a certain degree of comfort while correcting hallux valgus.

[0057] 3D printing technology can efficiently produce complex geometric shapes and structures with specific support performance, which are suitable for the customized needs of hallux valgus orthopedic insoles. In the present invention, an optical scanning device (such as a 3D scanner) is first used to scan the patient's foot to obtain the precise size and morphological data of the foot, and a detailed 3D model is generated, including the size, morphology and pressure distribution information of each key area of ​​the sole. Then, the insole is manufactured using fused deposition modeling (FDM) or stereolithography (SLA) technology. Preferably, the material of the insole body 1 can be thermoplastic polyurethane (TPU) material, which has good support, wear resistance, flexibility and comfort, and can be adaptively adjusted according to gait changes to ensure comfort for long-term wear. In addition, the TPU material also has high elasticity and durability, and can still maintain its properties and functions under long-term use, and can provide lasting support and correction without sacrificing comfort, ensuring a continuous correction effect. The surface of the insole body 1 can also be made of a highly breathable and antibacterial material, which can effectively reduce the generation of sweat and odor on the feet and keep it dry and comfortable. At the same time, the surface material is soft and durable, which can improve the comfort and durability of the insole, allowing patients to wear it for a long time without discomfort.

[0058] One end of the first elastic band 2 is fixedly connected to the insole body 1, and the other end has a first connecting portion 4. One end of the second elastic band 3 is fixedly connected to the insole body 1, and the other end has a second connecting portion 5. The third connecting portion 6 and the fourth connecting portion 7 are both fixedly arranged on the insole body 1, and the third connecting portion 6 can be fixedly connected to the first connecting portion 4, and the fourth connecting portion 7 can be fixedly connected to the second connecting portion 5. After the first connecting portion 4 and the third connecting portion 6 are connected, the first elastic band 2 can apply an inward force to the big toe, and after the second connecting portion 5 and the fourth connecting portion 7 are connected, the second elastic band 3 can apply an outward force to the first metatarsal. It should be noted that, for the foot structure, the big toe is located on the inside of the foot, and the little toe is located on the outside of the foot. The inside and outside of the insole body 1 correspond to the inside and outside of the foot structure. For specific orientation, please refer to the attached drawings. In the present invention, the first elastic band 2 can provide an inversion force on the patient's big toe. After the second connecting portion 5 on the second elastic band 3 and the fourth connecting portion 7 on the insole body 1 are fixedly connected, the second elastic band 3 can apply an eversion force to the first metatarsal, so that the first metatarsal cuneiform joint between the first metatarsal and the medial cuneiform is no longer overly flexible, thereby effectively controlling the angles of the big toe and the first metatarsal, improving the hallux valgus condition and the excessive flexibility of the first metatarsal cuneiform joint, improving the foot structure, and alleviating the symptoms of hallux valgus.

[0059] The first elastic band 2 and the second elastic band 3 are both made of elastic composite materials, such as elastic polyurethane or elastic polyester materials or other materials with certain tensile strength and good memory. The selection of materials ensures continuous traction and comfort during the correction process, and can also cope with the dynamic needs of daily gait changes, prevent excessive compression and discomfort, and maintain a stable correction effect during long-term use. It should be noted that the greater the elastic coefficient of the elastic band material, the greater the deformation of the material, and the greater the traction. The elastic band made of composite materials can improve the effectiveness of traction. That is, the greater the elastic coefficient of the material, the stronger the material's ability to resist deformation, and the better the traction effect.

[0060] In the present invention, the first elastic band 2 starts from the outer side of the big toe of the insole, goes around the big toe and is fixed to the bottom of the insole. That is to say, after the patient wears the insole, the fixed position of the first elastic band 2 and the insole body 1 is located on the outer side of the big toe, and the third connecting portion 6 is fixed to the bottom of the insole body 1, so that the movable end of the first elastic band 2 is fixed to the bottom of the insole body 1 through the connection between the first connecting portion 4 and the third connecting portion 6, thereby realizing that the first elastic band 2 applies an inward force to the big toe. The first elastic band 2 made of composite material provides a gentle force to the big toe, helps the big toe to be pulled back from the eversion state, and slows down or prevents further eversion deformation. The second elastic band 3 starts from the inner side of the first metatarsal of the insole, passes through the first metatarsal and the dorsum of the foot, and is finally fixed to the outer bottom of the insole. That is to say, after the patient wears the insole, the second elastic band 3 and the insole body 1 are fixed at the inner side of the first metatarsal, and the fourth connecting portion 7 is fixed at the bottom of the insole body 1, so that the movable end of the second elastic band 3 is fixed at the bottom of the insole body 1 through the connection between the second connecting portion 5 and the fourth connecting portion 7, thereby realizing that the second elastic band 3 exerts an outward force on the first metatarsal. The second elastic band 3 made of composite material provides stability support for the first metatarsal and exerts a moderate outward pulling force on the first metatarsal, preventing the first metatarsal cuneiform joint from being overly flexible or continuing to turn inward, helping to maintain the correct position of the first metatarsal and avoiding worsening of the disease. Through the coordinated work of the first elastic band 2 and the second elastic band 3, the purpose of correcting hallux valgus is achieved by maintaining the foot.

[0061] Combined with Figure 3 , Attachment Figure 4 The recessed structure 8 is provided on the insole body 1 and is used to fit the thumb, and the position where the first elastic band 2 and the insole body 1 are fixedly connected is located outside the recessed structure 8. The main function of the recessed structure 8 is to position the thumb, keep it in the correct position after correction, and provide support for the thumb, reduce hallux valgus, and alleviate the discomfort of the thumb. Preferably, the recessed structure 8 can be 3D printed together with the insole body 1. The recessed structure 8 is a curved semicircular pit to better fit the natural curve of the thumb, and the depth gradually transitions from the center of the pit to the edge to avoid uneven pressure; the deeper middle part and the shallower edge ensure that the thumb can be fully supported.

[0062] In some embodiments of the present invention, the first connection part 4 is connected to the third connection part 6 by Velcro; and / or the second connection part 5 is connected to the fourth connection part 7 by Velcro. The fixed connection design of Velcro allows the user to freely adjust the tension of the first elastic band 2 and the second elastic band 3 as needed, enhance the correction force, provide appropriate pressure distribution, flexibly adjust the force transmission to the hallux valgus lesion site, optimize the correction process, and ensure the comfort of the first elastic band 2 and the second elastic band 3 applying force to the patient's foot. It has strong flexibility, a wide range of applications, and a large demand for application. Velcro can be fixed to the elastic band and the insole by gluing, knitting, etc.

[0063] In other embodiments, the first connection part 4 and the third connection part 6, as well as the second connection part 5 and the fourth connection part 7, can also be connected by other connection methods such as magnetic sheet fixed connection, button connection, etc., as long as the use requirements are met. The advantage of the Velcro connection method in this embodiment is that the Velcro connection is not only convenient to use, but also has good firmness, which can ensure the stability of the elastic band in daily activities.

[0064] In some embodiments of the present invention, after the first connection part 4 is connected to the third connection part 6 and after the second connection part 5 is connected to the fourth connection part 7, at least the following conditions are satisfied: when the insole is worn, the direction of the force applied by the first elastic band 2 to the big toe is perpendicular to the long axis of the big toe; the point of action applied by the second elastic band 3 to the first metatarsal is located at the first metatarsal cuneiform joint and the direction of the force is the first direction, the direction of the heel to the toe of the insole body 1 is the second direction, and the angle between the first direction and the second direction is α, wherein: 45°≤α≤60°. The correction effect of hallux valgus is best when the direction of the force applied by the first elastic band 2 to the big toe is perpendicular to the long axis of the big toe, and the point of action applied by the second elastic band 3 to the first metatarsal is located at the first metatarsal cuneiform joint, and the direction of the force is in the range of 45° to 60° with the direction of the heel to the toe. In other embodiments, the point of action of the second elastic band 3 may be located in the middle of the first metatarsal. The angle of hallux valgus will change when the insole is worn, and the change of the angle is continuous. The advantage of the Velcro connection method is that it can achieve stepless adjustment, that is, Velcro is more widely used in micro-adjustment. During wearing and use, the direction and magnitude of the force of the first elastic band 2 and the second elastic band 3 can be changed by properly adjusting the connection position of the Velcro, so as to effectively control the direction and strength of hallux valgus correction.

[0065] In some embodiments of the present invention, the first elastic band 2 and / or the second elastic band 3 has a width of W and a thickness of T, wherein: 3cm≤W≤5cm; 0.1cm≤T≤0.5cm. Generally, since thicker materials provide stronger resistance when contacting the patient's foot, thicker elastic bands will result in increased traction but reduced comfort. The wider the elastic band, the smaller the traction applied per unit area when contacting the patient's foot, and the traction is dispersed by a larger area of ​​the elastic band. Although a narrower elastic band can produce a higher concentrated tension, it causes a larger local pressure that affects comfort.

[0066] In summary, the thickness and width of the elastic band need to be reasonably designed to balance the traction force exerted by the elastic band on the foot and the comfort when worn. Generally, patients with mild hallux valgus are suitable for elastic bands with a wider width and a thinner thickness. Since patients with mild hallux valgus have mild hallux valgus symptoms, comfort is given priority. Patients with moderate hallux valgus are suitable for elastic bands with a smaller width and a thicker thickness. Since patients with moderate hallux valgus have severe hallux valgus symptoms, correction effect is given priority.

[0067] Preferably, the first elastic band 2 has a width of 5 cm and a thickness of 0.3 cm; the second elastic band 3 has a width of 3 cm and a thickness of 0.3 cm. With such a design, a certain degree of comfort can be maintained while preventing hallux valgus.

[0068] In some embodiments of the present invention, after the first connection portion 4 on the first elastic band 2 is connected to the third connection portion 6, the force applied by the first elastic band 2 to the big toe is F1, wherein: 5N≤F1≤10N. After the second connection portion 5 on the second elastic band 3 is connected to the fourth connection portion 7, the force applied by the second elastic band 3 to the first metatarsal is F2, wherein: 10N≤F2≤20N. The force range of the first elastic band 2 and the second elastic band 3 is within the above range, which ensures the correction effect on the one hand and comfort on the other hand. It should be noted that the force of the elastic band is related to the hallux valgus angle. The larger the hallux valgus angle, the greater the force. In addition, the force of the elastic band is also positively correlated with the friction coefficient of the Velcro. The friction coefficient of a general Velcro is 0.6. Properly increasing the friction coefficient can increase the force of the elastic band.

[0069] In some embodiments of the present invention, the distance between the position where the first elastic band 2 and the insole body 1 are connected and the outer edge of the recessed structure 8 is d, and satisfies: d = f(θ) and θ = g(θ0). Wherein, θ0 is the hallux valgus angle and 15°≤θ0≤40°; g(θ0) is the value function of θ0; θ is the value obtained after the g(θ0) function is calculated; f(θ) is the positive correlation function of θ. In general, the larger the hallux valgus angle, the larger the distance between the starting point of the first elastic band 2 and the outer edge of the recessed structure 8.

[0070] In some embodiments of the present invention, g(θ0)=360*(θ0 / 360°), f(θ)=1+0.03θ. Among them, d is in centimeters. Specifically, when the hallux valgus angle is 20°, d is 1.6cm; when the hallux valgus angle is 25°, d is 1.75cm; when the hallux valgus angle is 30°, d is 1.9cm. At the beginning of the patient's hallux valgus correction process, the recessed structure 8 just supports the thumb, and the correction effect and comfort are the best at this time. During the correction process, the angle of hallux valgus will generally decrease (of course, it does not rule out the situation where the patient's hallux valgus symptoms worsen), causing the angle of hallux valgus to change. At this time, the recessed structure 8 will deviate from the thumb, and the longer the patient's correction time, the greater the degree of deviation of the recessed structure 8 from the thumb, and the worse the comfort.

[0071] In some embodiments of the present invention, f(θ)=1+0.03θ. Wherein, d is in centimeters. In this embodiment, the distance between the position where the first elastic band 2 and the insole body 1 are connected and the outer edge of the recessed structure 8 is set in sections. Specifically, when the hallux valgus is mild, d is 1.45 cm; when the hallux valgus is moderate, d is 1.9 cm.

[0072] In general, in the initial stage of the correction process, the position of the concave structure 8 deviates from the thumb and is located on the inner side of the thumb, which is uncomfortable, but the concave structure 8 can provide a certain guiding force for the thumb, and cooperate with the first elastic band 2 to make the thumb deviate inward. As the correction process proceeds, the concave structure 8 gradually fits the thumb, gradually enhancing the correction effect and comfort.

[0073] To further improve comfort and protect the skin, the surface of the insole can be covered with a layer of silicone material with good elasticity and wear resistance to reduce friction and protect the skin from pressure or abrasion. The silicone material is also antibacterial and can effectively prevent skin problems caused by long-term wear.

[0074] In some embodiments of the present invention, when 15°≤θ0<30°, the length*width*depth of the recessed structure 8 is 3.5cm*2cm*5mm; when 30°≤θ0≤40°, the length*width*depth of the recessed structure 8 is 4.5cm*2.5cm*7mm. The length, width and depth of the recessed structure 8 are perpendicular to each other, the length direction of the recessed structure 8 is consistent with the inner and outer sides of the insole body 1, the width direction of the recessed structure 8 is perpendicular to the length direction of the recessed structure 8, and the depth direction of the recessed structure 8 is perpendicular to the surface of the insole body 1. When the patient's foot is in mild or moderate hallux valgus, the size of the recessed structure 8 needs to be designed accordingly to provide appropriate guidance and support.

[0075] It should be noted that when the patient's foot is in mild or moderate hallux valgus, the position and size of the recessed structure 8 and the starting position of the first elastic band 2 will change. Therefore, the patient needs to return for a follow-up visit in time to replace the insole during the correction process.

[0076] The present invention also provides a method for manufacturing the 3D printed insole for hallux valgus correction as described above, as shown in the attached Figure 5 As shown and combined with the attached Figure 6 , Attachment Figure 7 , including the following production steps:

[0077] S1: Obtain the foot data date1 of the patient in the current state, which at least includes the hallux valgus angle and the foot shape contour, and determine the hallux valgus level of the patient according to the hallux valgus angle θ0. If: θ0<15°, it is determined that there is no hallux valgus, and step S11 is performed. If: 15°≤θ0<30°, it is determined to be mild hallux valgus, and step S2 is performed. If: 30°≤θ0<40°, it is determined to be moderate hallux valgus, and step S2 is performed. If: θ0≥40°, it is determined to be severe hallux valgus, and step S2 is performed.

[0078] S2: Obtain the patient's identity information and match the patient's identity information with the information database. If the match is successful and the patient's hallux valgus level is severe hallux valgus, proceed to step S11. If the match is successful and the patient's hallux valgus level is mild or moderate hallux valgus, retrieve the patient's information data file t0 from the information database and proceed to step S8. If the match is not successful, establish an information data file t1 that matches the patient's identity information, and include the information data file t1 in the information database, and proceed to step S3.

[0079] S3: According to the foot data date1 in the current state of the patient, simulate the patient's normal foot and obtain the patient's normal foot data date2, determine the insole body 1 contour data date3 of the patient's foot in the normal state based on the patient's normal foot data date2, enter date2 and date3 into the information data file t1, and proceed to step S4.

[0080] S4: If the hallux valgus level of the patient's foot in the current state is severe hallux valgus, proceed to step S11; if the hallux valgus level of the patient's foot in the current state is mild hallux valgus or moderate hallux valgus, proceed to step S5.

[0081] S5: According to the foot data date1 of the patient in the current state, calculate and obtain the position data of the recessed structure 8 on the insole body 1 and the size data date4 of the recessed structure 8, the fixed position data date5 of the first elastic band 2 and the insole body 1, and the fixed position data date6 of the second elastic band 3 and the insole body 1, and proceed to step S6.

[0082] S6: According to date3 and date4, the insole body 1 and the recessed structure 8 on the insole body 1 are manufactured by 3D printing technology, and then the first elastic band 2 and the second elastic band 3 are fixed to the insole body 1 according to date5 and date6, and step S7 is performed.

[0083] S7: a first connection portion 4 is arranged on the end of the first elastic band 2 away from the insole body 1, a second connection portion 5 is arranged on the end of the second elastic band 3 away from the insole body 1, a third connection portion 6 and a fourth connection portion 7 are arranged on the insole body 1, and step S11 is performed.

[0084] S8: Read the patient's foot data date2 in a normal state and the insole body 1 contour data date3 in a normal state in the information data file t0, and calculate the position data of the recessed structure 8 on the insole body 1 and the size data date4 of the recessed structure 8, the fixed position data date5 of the first elastic band 2 and the insole body 1, and the fixed position data date6 of the second elastic band 3 and the insole body 1 according to the patient's foot data date1 in the current state, and proceed to step S9.

[0085] S9: According to date3 and date4, the insole body 1 and the recessed structure 8 on the insole body 1 are manufactured by 3D printing technology, and then the first elastic band 2 and the second elastic band 3 are fixed to the insole body 1 according to date5 and date6, and step S10 is performed.

[0086] S10: a first connection portion 4 is provided on the end of the first elastic band 2 away from the insole body 1, a second connection portion 5 is provided on the end of the second elastic band 3 away from the insole body 1, a third connection portion 6 and a fourth connection portion 7 are provided on the insole body 1, and step S11 is performed.

[0087] S11: End.

[0088] The preferred embodiments of the present invention are described in detail above. However, the present invention is not limited to the specific details in the above embodiments. Within the technical concept of the present invention, a variety of simple modifications can be made to the technical solution of the present invention, and these simple modifications all belong to the protection scope of the present invention.

[0089] It should also be noted that the various specific technical features described in the above specific embodiments can be combined in any suitable manner without contradiction. In order to avoid unnecessary repetition, the present invention will not further describe various possible combinations.

[0090] In addition, various embodiments of the present invention may be arbitrarily combined, and as long as they do not violate the concept of the present invention, they should also be regarded as the contents disclosed by the present invention.

Claims

1. A 3D printed insole for hallux valgus correction, characterized in that: include: An insole body (1), the insole body (1) being manufactured by 3D printing technology, and having a recessed structure (8) for fitting a thumb; A first elastic band (2), one end of the first elastic band (2) being fixedly connected to the insole body (1), and the other end of the first elastic band (2) having a first connecting portion (4); A second elastic band (3), one end of the second elastic band (3) is fixedly connected to the insole body (1), and the other end of the second elastic band (3) has a second connecting portion (5); A third connecting portion (6), the third connecting portion (6) being fixedly arranged on the insole body (1) and being capable of being fixedly connected to the first connecting portion (4); a fourth connecting portion (7), the fourth connecting portion (7) being fixedly arranged on the insole body (1) and being capable of being fixedly connected to the second connecting portion (5); The position where the first elastic band (2) and the insole body (1) are fixedly connected is located outside the recessed structure (8); after the first connecting portion (4) is connected to the third connecting portion (6), the first elastic band (2) can exert an inward force on the big toe; and after the second connecting portion (5) is connected to the fourth connecting portion (7), the second elastic band (3) can exert an outward force on the first metatarsal.

2. The 3D printed insole for hallux valgus correction according to claim 1, characterized in that: The distance between the position where the first elastic band (2) and the insole body (1) are fixedly connected and the outer edge of the recessed structure (8) is d, and the following conditions are satisfied: d=f(θ) and θ=g(θ0); Wherein, θ0 is the hallux valgus angle and is 15°≤θ0≤40°; g(θ0) is the value function of θ0; θ is the value obtained after calculating the g(θ0) function; f(θ) is the positive correlation function of θ.

3. The 3D printed insole for hallux valgus correction according to claim 2, characterized in that: g(θ0)=360*(θ0 / 360°), f(θ)=1+0.03θ; Here, d is in centimeters.

4. The 3D printed insole for hallux valgus correction according to claim 2, characterized in that: Here, d is in centimeters.

5. The 3D printed insole for hallux valgus correction according to any one of claims 2 to 4, characterized in that: When 15°≤θ0<30°, the length*width*depth dimensions of the recessed structure (8) are 3.5 cm*2 cm*5 mm; when 30°≤θ0≤40°, the length*width*depth dimensions of the recessed structure (8) are 4.5 cm*2.5 cm*7 mm; The length, width and depth directions of the recessed structure (8) are perpendicular to each other, the length direction of the recessed structure (8) is consistent with the inner and outer sides of the insole body (1), the width direction of the recessed structure (8) is perpendicular to the length direction of the recessed structure (8), and the depth direction of the recessed structure (8) is perpendicular to the surface of the insole body (1).

6. The 3D printed insole for hallux valgus correction according to claim 1, characterized in that: After the first connecting portion (4) on the first elastic band (2) is connected to the third connecting portion (6), the force applied by the first elastic band (2) on the big toe is F1, wherein: 5N≤F1≤10N; after the second connecting portion (5) on the second elastic band (3) is connected to the fourth connecting portion (7), the force applied by the second elastic band (3) on the first metatarsal is F2, wherein: 10N≤F2≤20N.

7. The 3D printed insole for hallux valgus correction according to claim 1, characterized in that: The width of the first elastic band (2) and / or the second elastic band (3) is W, and the thickness is T, wherein: 3cm≤W≤5cm; 0.1cm≤T≤0.5cm.

8. The 3D printed insole for hallux valgus correction according to claim 1, characterized in that: The first connecting portion (4) and the third connecting portion (6) are connected via Velcro; and / or The second connecting portion (5) and the fourth connecting portion (7) are connected via Velcro.

9. The 3D printed insole for hallux valgus correction according to claim 1 or 8, characterized in that: After the first connecting portion (4) is connected to the third connecting portion (6), and after the second connecting portion (5) is connected to the fourth connecting portion (7), at least the following conditions are satisfied: when the insole is worn, the direction of the force applied by the first elastic band (2) to the big toe is perpendicular to the long axis of the big toe; the point of action of the second elastic band (3) on the first metatarsal bone is located at the first metatarsal cuneiform joint and the direction of the force is the first direction; the direction in which the heel of the insole body (1) extends toward the toe is the second direction; the angle between the first direction and the second direction is α, wherein: 45°≤α≤60°.

10. A method for manufacturing a 3D printed insole for hallux valgus correction as claimed in any one of claims 1 to 9, characterized in that: The production steps include: S1: obtaining foot data date1 of the patient in the current state, which at least includes the hallux valgus angle and the foot shape contour, and determining the hallux valgus level of the patient according to the hallux valgus angle θ0; If: θ0<15°, it is determined that there is no hallux valgus, and step S11 is performed; If: 15°≤θ0<30°, it is determined to be mild hallux valgus, and step S2 is performed; If: 30°≤θ0<40°, it is determined to be moderate hallux valgus, and step S2 is performed; If: θ0≥40°, it is determined to be severe hallux valgus, and step S2 is performed; S2: Obtain patient identity information and match the patient identity information with the information database; If: the match is successful, and the patient's hallux valgus level is severe hallux valgus, proceed to step S11; If: the match is successful, and the patient's hallux valgus level is mild hallux valgus or moderate hallux valgus, then retrieve the patient's information data file t0 from the information database and proceed to step S8; If the match is not successful, an information data file t1 matching the patient's identity information is created, and the information data file t1 is included in the information database, and step S3 is performed; S3: According to the foot data date1 of the patient in the current state, simulate the normal state of the patient's foot and obtain the foot data date2 of the patient in the normal state, determine the contour data date3 of the insole body (1) of the patient's foot in the normal state based on the foot data date2 of the patient, enter date2 and date3 into the information data file t1, and proceed to step S4; S4: If the hallux valgus level of the patient's foot is currently severe hallux valgus, proceed to step S11; If the hallux valgus level of the patient's foot in the current state is mild hallux valgus or moderate hallux valgus, proceed to step S5; S5: according to the foot data date1 of the patient in the current state, calculate and obtain the position data of the recessed structure (8) on the insole body (1) and the size data date4 of the recessed structure (8), the fixed position data date5 of the first elastic band (2) and the insole body (1), and the fixed position data date6 of the second elastic band (3) and the insole body (1), and proceed to step S6; S6: According to date 3 and date 4, the insole body (1) and the recessed structure (8) on the insole body (1) are manufactured by using 3D printing technology, and then according to date 5 and date 6, the first elastic band (2) and the second elastic band (3) are fixed to the insole body (1), and step S7 is performed; S7: a first connection portion (4) is provided on the end of the first elastic band (2) away from the insole body (1), a second connection portion (5) is provided on the end of the second elastic band (3) away from the insole body (1), a third connection portion (6) and a fourth connection portion (7) are provided on the insole body (1), and step S11 is performed; S8: reading the patient's foot data date2 in a normal state and the insole body contour data date3 in a normal state in the information data file t0, and calculating the position data of the recessed structure (8) on the insole body (1) and the size data date4 of the recessed structure (8), the fixed position data date5 of the first elastic band (2) and the insole body (1), and the fixed position data date6 of the second elastic band (3) and the insole body (1) according to the foot data date1 in the current state of the patient, and proceeding to step S9; S9: According to date 3 and date 4, the insole body (1) and the recessed structure (8) on the insole body (1) are manufactured by using 3D printing technology, and then according to date 5 and date 6, the first elastic band (2) and the second elastic band (3) are fixed to the insole body (1), and step S10 is performed; S10: a first connection portion (4) is provided on the end of the first elastic band (2) away from the insole body (1), a second connection portion (5) is provided on the end of the second elastic band (3) away from the insole body (1), a third connection portion (6) and a fourth connection portion (7) are provided on the insole body (1), and step S11 is performed; S11: End.

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