A kind of children's ankle-foot orthosis and its manufacturing method

Abstract

The present invention relates to the field of 3D printing technology, and specifically to a pediatric ankle-foot orthosis and a method for making the same, comprising the following steps: obtaining plantar data of a child to be corrected, and inputting the data into 3D printing software to obtain three-dimensional data of the sole of the orthosis; obtaining calf data of the child to be corrected, and loading the data into Magics21 software to obtain leg data of the orthosis; combining the sole and leg of the orthosis using Boolean operation tools; optimizing the combined orthosis, and printing and making the required ankle-foot orthosis through a 3D printer after matching inspection. The method of the present invention has a simple process, and the preliminary work only needs a short time to complete scanning and plantar data collection, and the family members have higher compliance. The later design and production only needs to master the use of Magics software, and the technical threshold is low, and it can be mastered after a short training, and the production cost is within a controllable range, which is suitable for clinical promotion.

Description

Technical Field

[0001] The present invention relates to the technical field of 3D printing, and in particular to a children's ankle-foot orthosis and a manufacturing method thereof. Background Art

[0002] Cerebral palsy in children is one of the diseases that cause limb disability in children in my country. The use of orthotics to assist in the rehabilitation of cerebral palsy is gaining more and more attention. Ankle-foot orthoses, also known as calf orthoses, cover the calf and foot [1] and can improve the standing and walking function of children with cerebral palsy and prevent joint deformities. There are many shortcomings in the traditional production of ankle-foot orthoses, including complex production processes, long production time, and some orthoses that are not completely suitable for patients [2]. At present, 3D printing technology is booming, and relying on this technology to complete the production of ankle-foot orthoses is a future development trend and is inevitable.

[0003] The emergence of 3D scanners is the basis for the production and printing of orthoses. Through scanning, accurate data of the child's lower leg is directly obtained, and then 3D data processing software is used for corresponding processing. According to the mechanical changes and needs of the lower limbs of children with cerebral palsy, a fine orthosis that matches the complex anatomical structure of the foot and ankle is produced. In this way, the orthosis can continuously develop new features and new functions, realizing the true "individualization" of the orthosis [3].

[0004] Our hospital has applied the ankle-foot orthosis made by 3D printing technology to the clinical treatment of cerebral palsy in children, and achieved good results. This paper reports a successful clinical application case of the design scheme, production method, process, and post-use evaluation of 3D printed individualized ankle-foot orthosis for a child with cerebral palsy for reference and discussion.

[0005] There are many shortcomings in the traditional production of ankle-foot orthoses, including complex production processes, long production time, and some orthoses that cannot fully fit patients. The emergence of 3D scanners is the basis for making and printing orthoses. The calf data is obtained through the scanner and processed by software. The best ankle-foot orthosis printed by 3D printer has better fit and comfort, and can be optimized to reduce weight and increase the coordination of children wearing orthoses. Summary of the invention

[0006] In view of the deficiencies in the prior art, the present invention discloses a children's ankle-foot orthosis and a manufacturing method thereof, which are used to solve the above-mentioned problems.

[0007] The present invention is achieved through the following technical solutions:

[0008] In a first aspect, the present invention provides a method for manufacturing a pediatric ankle-foot orthosis, comprising the following steps:

[0009] S1 obtains the sole data of the child to be corrected, and inputs the data into the 3D printing software to obtain the three-dimensional data of the sole of the orthosis;

[0010] S2 obtains the calf data of the child to be corrected, and loads the data into Magics21 software to obtain the leg data of the orthosis;

[0011] S3 combines the sole and the leg of the orthosis according to the data in S1 and S2 and using Boolean operation tools;

[0012] S4 optimizes the combined orthosis and prints the required ankle-foot orthosis through a 3D printer after matching inspection.

[0013] Furthermore, in the method, the plantar data includes the total length of the foot, the total inner length, the total outer length, the toe radius, the inner width, the outer width, the distance from the lowest point of the inner edge of the foot to the midline, the distance from the lowest point of the outer edge of the foot to the midline and the heel radius data.

[0014] Furthermore, the method inputs the plantar data into the 3D printing insole design software Gensole to obtain the three-dimensional data of the orthotic sole.

[0015] Furthermore, in the method, when scanning and obtaining calf data, the child stands and the calf is scanned using a three-dimensional scanner. During the scanning process, the calf is perpendicular to the surface of the foot and the sole of the foot faces forward. The scanning time is 0.5-1.5 minutes.

[0016] Furthermore, in the method, when scanning to obtain calf data, data of the dorsal side of the calf and both sides of the foot are obtained, and the data are processed by the 3D Systems Sense software supporting the scanner to generate a three-dimensional data file of the child's calf.

[0017] Furthermore, in the method, when designing the leg of the orthosis, the scanned calf data is loaded into the Magics21 software, and the overall shell of the calf orthosis is first obtained through the hollow part function, and the hollow wall thickness selection range is 2.7-3.5mm. The multi-segment wire cutting tool is used to remove unnecessary parts on the front of the calf to obtain the leg data of the orthosis.

[0018] Furthermore, in the method, when combining the sole and leg of the orthosis, the software's translation, rotation, and alignment tools are used to make the designed sole overlap with the sole of the child's foot, and the Boolean operation tools are used to combine the two parts of the sole and the leg guard, and finally, detailed cutting and repair are performed to obtain a static orthosis data model.

[0019] Furthermore, in the method, the static orthosis data model is obtained and enlarged to wrap the child's calf and be 2-3 mm away from the skin, and 5-10 mm longer than the sole of the foot.

[0020] Furthermore, in the method, when performing the matching check, the distance between the skin and the orthosis at each angle is observed and measured to see whether it is maintained at 2-3 mm.

[0021] In a second aspect, the present invention provides a pediatric ankle-foot orthosis, which is made by the method described in any one of claims 1 to 9 and is used for ankle-foot orthosis of children.

[0022] The beneficial effects of the present invention are:

[0023] The method of the present invention has a simple process, and the preliminary work only needs a short time to complete the scanning and plantar data collection, and the family members have higher compliance. The later design and production only need to master the use of Magics software, and the technical threshold is low, and it can be mastered after a short training, and the production cost is within a controllable range, which is suitable for clinical promotion. The ankle-foot orthosis of the present invention has better fit and comfort, and can be optimized to reduce weight, and increase the coordination of children wearing orthosis. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0025] Figure 1 is a three-dimensional diagram of the ankle-foot orthosis for children of the present invention;

[0026] Figure 2 A three-dimensional image of a printed sole of a children's ankle-foot orthosis according to the present invention;

[0027] Figure 3 A three-dimensional image of a printed leg guard of a children's ankle-foot orthosis according to the present invention;

[0028] Figure 4 A three-dimensional view of the rear assembly of the sole and leg guard of the children's ankle-foot orthosis of the present invention;

[0029] Figure 5 This is a diagram showing the effect of the children's ankle-foot orthosis of the present invention after optimized weight reduction and ventilation.

[0030] Figure 6 A finished picture of the ankle-foot orthosis for children of the present invention;

[0031] Figure 7 The embodiment of the present invention is a diagram of scanning and obtaining calf data;

[0032] Figure 8 is a diagram of the sole of an orthosis designed according to an embodiment of the present invention;

[0033] Fig. 9 It is a diagram of a static orthosis designed according to an embodiment of the present invention;

[0034] Fig.10 It is a diagram of a dynamic orthosis designed according to an embodiment of the present invention;

[0035] Fig.11 It is a finished product diagram of an embodiment of the present invention. DETAILED DESCRIPTION

[0036] In order to make the purpose, technical solution and advantages of the embodiments of the present invention clearer, the technical solution in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0037] Example 1

[0038] This embodiment provides a method for manufacturing a pediatric ankle-foot orthosis, comprising the following steps:

[0039] S1 obtains the sole data of the child to be corrected, and inputs the data into the 3D printing software to obtain the three-dimensional data of the sole of the orthosis;

[0040] S2 obtains the calf data of the child to be corrected, and loads the data into Magics21 software to obtain the leg data of the orthosis;

[0041] S3 combines the sole and the leg of the orthosis according to the data in S1 and S2 and using Boolean operation tools;

[0042] S4 optimizes the combined orthosis and prints the required ankle-foot orthosis through a 3D printer after matching inspection.

[0043] When designing the sole of the orthosis in this embodiment, the sole data of the child is measured, including the total length of the foot, the total length of the inner side, the total length of the outer side, the radius of the toes, the inner width, the outer width, the distance from the lowest point of the inner edge of the foot to the midline, the distance from the lowest point of the outer edge of the foot to the midline, the heel radius, etc. The data is input into the 3D printing insole design software Gensole to obtain the three-dimensional data of the orthosis sole.

[0044] When scanning and obtaining calf data in this embodiment, the child stands, and a family member sits in front of the child and holds the child steady. At this time, the 3D scanner can be used to scan the child's calf. During the scanning process, the calf is perpendicular to the surface of the foot, and the sole of the foot faces forward. The scanning time is about 1 minute. There is no need to scan the front. Only the data of the dorsal side of the calf and the sides of the foot need to be obtained, and the data is processed by the 3D Systems Sense software that comes with the scanner to generate a 3D data file of the child's calf.

[0045] The Sense2 generation 3D scanner used in this embodiment is an infrared sensing scanning device with low cost. No markers need to be attached before scanning. Just make sure there is sufficient light. The scanning accuracy meets the requirements for designing orthotics.

[0046] This embodiment adopts a method of separately designing the sole and the upper, so there is no need for a 360-degree scan. Family members can stand in front of the child to support the child, which provides a high level of safety for the child. Moreover, only the back of the calf and both sides of the foot need to be scanned, so the scanning time is shorter, which is especially suitable for children with poor cooperation.

[0047] When designing the leg of the orthosis in this embodiment, the scanned calf data is loaded into the Magics21 software, and the overall shell of the calf orthosis is first obtained through the hollow parts function. The hollow wall thickness can be selected in the range of 2.7 to 3.5 mm. The thinner the wall, the lighter it is, and the thicker the wall, the more durable it is. The specific thickness depends on the clinical characteristics and usage of the child. The multi-segment wire cutting tool removes the unnecessary part of the front of the calf to obtain the leg data of the orthosis.

[0048] In this embodiment, when the sole and the leg of the orthosis are combined together, the software's translation, rotation, alignment and other tools are used to make the designed sole overlap with the sole of the child's foot, and the Boolean operation tool is used to combine the two parts of the sole and the leg guard together. Finally, detailed cutting and repair are performed to obtain a static orthosis data model, and the model is appropriately enlarged to wrap the child's calf, with a distance of 2-3 mm from the skin and a length that is 5-10 mm longer than the sole of the foot.

[0049] Compared with the traditional orthosis manufacturing method, the process of this embodiment is simpler, and the preliminary work only needs a shorter time to complete the scanning and plantar data collection, and the family compliance is higher; the later design and production only requires proficiency in the use of Magics software, and the technical threshold is low, which can be mastered after a short training; and the production cost is within a controllable range, which is suitable for clinical promotion.

[0050] This embodiment requires optimization of the orthosis. Specifically, holes are punched in places where the orthosis is subjected to less force, such as the back of the calf. This can reduce the weight of the orthosis and increase ventilation and air permeability to improve wearing comfort.

[0051] Before printing, the scanned calf data of this embodiment is imported for final matching check, and the distance between the skin and the orthosis at various angles is observed and measured. Generally, it is best to maintain 2-3mm. On the one hand, it is convenient to paste the protective liner, and on the other hand, it can avoid compression of local load parts. Finally, the required ankle-foot orthosis is printed and manufactured through a 3D printer, and the protective belt and other parts are assembled to obtain the finished product.

[0052] Example 2

[0053] In terms of specific implementation, this embodiment selects a 3-year-old and 4-month-old child who has been receiving rehabilitation treatment in the pediatric rehabilitation ward of our hospital since he was 1 year old due to "cerebral palsy and sequelae of viral encephalitis".

[0054] In this embodiment, the plantar prints of both feet of the child in a standing position are taken, and the plantar data of the child is measured according to the software requirements by using the 3D printing insole online design tool Gensole software, including the total length of the foot, the total length of the inner side, the total length of the outer side, the radius of the toes, the distance from the lowest point of the inner edge of the foot to the midline, the distance from the lowest point of the outer edge of the foot to the midline, the radius of the heel, etc. In order to minimize the experimental error, three sets of data need to be measured manually, and the results are finally averaged.

[0055] In this embodiment, the data is input into the Gensole software to obtain the three-dimensional data of the orthotic sole as follows: the total length of the sole is 165 mm, the total length of the inner side is 132 mm, the total length of the outer side is 132 mm, the toe radius is 30 mm, the inner width is 35 mm, the outer width is 35 mm, the distance from the lowest point of the inner edge of the foot to the midline is 23 mm, the distance from the lowest point of the outer edge of the foot to the midline is 25 mm, the heel radius is 26 mm, the insole thickness at the toe is 3 mm, and the insole thickness at the heel is 3 mm.

[0056] The Gensole software in this embodiment is a simple, easy-to-use, free 3D printed insole design tool, which covers 3D printed insole design software and printing solutions. Users can complete the design of 3D printed insoles through a web browser APP. Figure 2 shown.

[0057] In this embodiment, the child takes a standing position, and a family member sits in front of the child to hold the child steady, keeping the calf perpendicular to the foot and the sole facing forward. The Sense2 generation 3D scanner is used to scan the child's calf for 1 minute to obtain data on the dorsal side of the calf and both sides of the foot.

[0058] In this embodiment, the data is processed by the supporting 3D Systems Sense software to generate a three-dimensional data file of the child's calf: the calf length is 165.4 mm, the toe surface width is 70.5 mm, the heel surface width is 52.4 mm, and the height is 221 mm.

[0059] In this example, the scanned calf data is loaded into Magics 21.0 software. The overall shell of the calf orthosis is first obtained through the hollow parts function of the software. The thickness of the hollow wall is selected to be 3.0 mm. The multi-segment line cutting tool of the software is used to remove the unnecessary part of the front of the calf. The result is shown in Figure 3 shown.

[0060] In this example, Magics 21.0 software's translation, rotation, alignment and other tools are used to make the designed sole overlap with the child's foot, and then the Boolean operation tool is used to combine the sole and the orthosis leg parts together. Finally, the details are cut and repaired to obtain the static orthosis data model. The model width is enlarged by 6mm through the scaling function to wrap the child's calf, and the length is enlarged by 6mm. Results can be found in Figure 4 shown.

[0061] The Magics21.0 software in this embodiment is a rapid prototyping-aided design software newly launched by Materialise in 2017. It has powerful Boolean operations, triangle reduction, smoothing, collision detection, shear repair and other functions. It is a professional and easy-to-use 3D model processing software with simple operation and low technical threshold. It can be mastered after only a short training.

[0062] In this embodiment, holes are punched in places where the orthosis is less stressed, so as to reduce the weight of the orthosis and increase ventilation. Figure 5 shown.

[0063] Before printing, this embodiment imports the previously scanned calf data for final matching check, observes and measures the distance between the skin and the orthosis at each angle, and maintains 2-3mm. Finally, the required ankle-foot orthosis is printed by a 3D printer, and the protective belt and other parts are assembled to obtain the finished product. The final orthosis data is 171.3mm long, 76.6mm wide, 56.5mm wide, and 191.2mm high. See the results for details. Figure 1 shown.

[0064] Example 3

[0065] At another level of specific implementation, this embodiment selects a child, male, 3 years and 2 months old, who has been receiving rehabilitation treatment in the pediatric rehabilitation ward of our hospital due to "sequelae of encephalitis and cerebral palsy". The lower limbs are now crossed, the feet are pointed when standing, and the child can walk with hands, objects / walls, and has a scissor gait. The gross motor function is graded as II. Deformities of the lower leg bones or ankle joints have been ruled out.

[0066] In this embodiment, since the child could not fully cooperate after admission, 10% chloral hydrate was used for sedation with the consent of the family members. After that, the child was placed prone on the examination bed with the feet close to the wall. The Sense2 generation 3D scanner was used to scan the child's calf. During the scanning process, the calf was perpendicular to the sole of the foot, the sole of the foot was facing forward, and the scanning time was 50 seconds.

[0067] This embodiment does not need to scan the front, but only needs to obtain data on the back of the calf and both sides of the foot (such as Figure 7 ), and the 3D data stl file of the child's lower leg is generated through the 3D Systems Sense software that comes with the scanner.

[0068] This embodiment directly measures the sole data of the child, including the total length of the foot, the total length of the inner side, the total length of the outer side, the radius of the toes, the inner width, the outer width, the distance from the lowest point of the inner edge of the foot to the midline, the distance from the lowest point of the outer edge of the foot to the midline, the radius of the heel, the thickness of the insole at the toes, and the thickness of the insole at the heel. The data is input into the 3D printing insole design software Gensole to obtain the three-dimensional data of the orthotic sole ( Figure 8 ) and save it as an stl file.

[0069] In this embodiment, the stl file generated by the above processing is loaded into Magics21 software. The overall shell of the orthosis is first obtained through the hollow part function. The hollow wall thickness selection range is 3.5m, and the multi-segment wire cutting tool is used to remove the unnecessary part of the front of the calf.

[0070] In this embodiment, the designed sole is aligned with the sole of the child's foot by using the translation, rotation, alignment and other tools of the software ( Fig. 9 The two parts are combined by Boolean operation tools, and finally the static orthosis data model is obtained by detailed cutting and repair ( Fig. 9 in Part B).

[0071] The model of this embodiment is appropriately enlarged to wrap the calf of the child, with a distance of 2-3 mm from the skin and a length 5-10 mm longer than the sole of the foot.

[0072] This embodiment imports the pre-scanned three-dimensional data of the elastic ankle hinge, and translates it to the ankle joint so that it is close to the lateral ankle joint ( Fig.10 Part A in the figure), and make dynamic ankle-foot orthosis by cutting, designing and wrapping ( Fig.10 When designing, the elastic ankle hinge should not extend beyond the inner surface of the orthosis to avoid compressing the ankle joint.

[0073] In this embodiment, the ankle joint is subjected to greater forces, and the package is designed by using functions such as moving part points in the software so that the outer package is completely bonded to the upper.

[0074] In this embodiment, the previously scanned calf data is imported before printing for final matching check ( Fig.11 Observe and measure the distance between the skin and the orthosis at various angles. Generally, it is best to maintain a distance of 2-3mm. On the one hand, it is convenient to stick the protective liner, and on the other hand, it can avoid compression of the local load-free part. Finally, the required ankle-foot orthosis is printed and made through cloud printing. The printing and mailing time is generally 3-4 days. The hinges, Velcro and other parts are assembled to obtain the finished product.

[0075] The finished product of the dynamic ankle-foot orthosis of this embodiment ( Fig.11 Part B of the study), the effect of wearing a static ankle-foot orthosis ( Fig.11 Part C of the study), Dynamic ankle-foot orthosis wearing effect ( Fig.11 in Section D).

[0076] In this embodiment, before wearing the orthosis, the family members are introduced in detail to the structure and function of the orthosis, and the correct wearing method and steps are guided so that the family members can fully master the wearing skills, and at the same time, the family members are taught to guide the child to relax and cooperate. When fitting the orthosis for the child for the first time, we need to patiently introduce the occurrence, development and prognosis of the child's disease to the family members, educate the family members to overcome anxiety and inferiority, and encourage the child to accept wearing the orthosis.

[0077] Example 4

[0078] This example conducts clinical assessment on the case in implementation 3, and uses the gross motor function measure-88 (GMFM-88) D and E areas for evaluation before and after treatment. The child's gross motor function test D distinction value before treatment was 31.2, and the E distinction value was 51.0; after treatment, the gross motor function test D distinction value was 34.8, and the E distinction value was 56.7.

[0079] In this embodiment, the user experience of the orthosis was evaluated using the Quebec user evaluation satisfaction technology (QUEST) [4] after wearing the orthosis for 3 months.

[0080] The evaluation items in this embodiment include 12 dimensions: size, weight, adjustability, safety, durability, ease of use, comfort, effectiveness, cycle, maintenance, professional service and follow-up service [5].

[0081] In this embodiment, each item is scored from 1 to 5 points, 1 point: very dissatisfied, 2 points: dissatisfied, 3 points: average, 4 points: satisfied, 5 points: very satisfied, and the higher the score, the better the use experience of the children and their families.

[0082] The walking function of the child in this example was significantly improved after wearing the orthosis, and the gross motor function was improved compared with before. No redness, swelling or damage of the foot skin occurred, and no phenomenon such as airtightness and excessive sweating of the feet was found. It is easy for family members to master the wearing and adjustment skills. At the same time, our hospital is equipped with fixed professional doctors for the maintenance and follow-up services of the orthosis to facilitate the follow-up services in the later stage.

[0083] In this example, after the child wore the orthosis for 3 months, we conducted a satisfaction assessment on the family members. The family members were very satisfied with the size, weight, ease of adjustment, safety, durability, ease of use, comfort, and effectiveness of the orthosis, and rated it 5 points; they were also satisfied with the cycle, maintenance, professional service, and follow-up service, and rated it 4 points. (The family members said that the child did not wear the orthosis for a long enough time, and they hoped that the maintenance and follow-up service of the orthosis could be provided by door-to-door service, so the score did not reach 5 points.)

[0084] In recent years, the application research of traditional orthotics based on 3D printing technology has made certain progress at home and abroad. In the field of orthopedics, bone models, orthopedic surgical auxiliary materials, and orthopedic implants can be printed [5]. In oral surgery, personalized brackets and invisible dentures can be printed [7]. In the field of children's rehabilitation, spinal orthotics can be printed to correct scoliosis [8, 9], all of which have achieved good results. There are many ways to model 3D models, such as direct modeling, which uses professional originals such as AutoCAD and 3dsmax

[10] to directly depict the three-dimensional data of the child's lower leg. This method is difficult and time-consuming, and is not suitable for clinical application.

[0085] In the medical field, imaging data modeling using spiral CT

[11] and magnetic resonance imaging

[12] is often used. Especially in the field of orthopedics, patients often have complete CT data when they are hospitalized. After exporting personalized data, they can be processed using software such as Mimics Research. Another major modeling method is modeling using a 3D scanner

[12] , also known as reverse modeling. It has many application industries, such as automobiles, molds, jewelry, wood carvings, etc. A scanner needs to be purchased, and the cost of subsequent scanning is negligible. It is suitable for scanning and making ankle-foot orthoses in this article. There are also many types of 3D modeling and processing software, such as ProE

[14] , UG

[15] , GeomagicStudio

[16] and other software. Although Materialise Magics is not as powerful as the above software, it is simple to understand and easy to operate, and is suitable for designing and making ankle-foot orthoses. Currently, there are many kinds of materials for 3D printing

[17] .

[0086] The printing material used in the present invention is nylon fiber-reinforced nylon. Nylon is printed by powder sintering and has the characteristics of good toughness and high strength

[18] . After adding glass fiber, its strength is higher than that of ordinary nylon material, and its impact resistance and bending strength are stronger. It has excellent mechanical properties and can be used to design thinner and lighter orthoses. It is very suitable for printing children's ankle-foot orthoses.

[0087] The most important thing about 3D printing ankle-foot orthoses for children is to build a model first. In the field of medicine, scholars at home and abroad currently use MRI and CT data collection for modeling. Ankle-foot orthoses for children often need to be replaced as they grow older. The cost of repeated use of CT and MR modeling is high. CT examinations also have a certain amount of radiation. Children have poor cooperation and cannot be recognized by their families. The modeling process cannot be scanned in a standing position. How to maintain the alignment of the calf, foot, and ankle joint when lying flat is also relatively difficult. The generated DICOM data still needs to be processed by multiple software. For medical personnel, the technology is difficult and difficult to master. The process is cumbersome and time-consuming. It is difficult to make the toes smooth. It is suitable for some research designs, but not suitable for clinical promotion and application.

[0088] Some domestic scholars have also chosen to use laser 3D scanners for scanning and modeling. The advantage is high precision, but the disadvantage is that the scanner is expensive. It is not the combined method used in this article to make orthoses. Human scanning is a scanning method that cannot rotate the target, so a handheld scanner is required to rotate 360 ​​degrees for scanning, which is time-consuming. If jitter occurs during the scanning process, it will affect the quality of the modeling and increase the amount of data processing. The smooth processing of the toe part requires the application of multiple software and also requires more complex technology. The orthosis produced is less beautiful, and there is no report on the design and production of dynamic ankle-foot orthoses.

[0089] The present invention uses the Sense2 generation three-dimensional scanner, which is an infrared sensing scanning device with low cost. No markers need to be pasted before scanning. Just make sure there is sufficient light. The scanning accuracy meets the requirements for designing orthotics.

[0090] The present invention adopts a separate design of the sole and the upper, so there is no need for a 360-degree scan. Family members can stand in front of the child to support the child, and the child has a high sense of security. Moreover, only the sides and the back of the foot need to be scanned, so the scanning time is shorter, which is especially suitable for children with poor cooperation.

[0091] The present invention obtains the data of the upper and surface of the ankle-foot orthosis by scanning, and manufactures the sole surface of the ankle-foot orthosis by applying the tool Gensole or taking a footprint contour image. The two are combined together to manufacture a complete ankle-foot orthosis, successfully solving the design difficulties caused by scanning difficulties and uneven toe surfaces.

[0092] Compared with traditional orthosis manufacturing, the ankle-foot orthosis manufactured by the present invention has a simple process, and the preliminary work only requires a short time to complete scanning and plantar data collection, and the family members have higher compliance. The later design and production only requires proficiency in the use of Magics software, and the technical threshold is low, which can be mastered after a short training, and the production cost is within a controllable range, which is suitable for clinical promotion.

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[0112] The above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit the same. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that the technical solutions described in the aforementioned embodiments may still be modified, or some of the technical features may be replaced by equivalents. However, these modifications or replacements do not deviate the essence of the corresponding technical solutions from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A method for manufacturing a pediatric ankle-foot orthosis, characterized in that: The method comprises the following steps: S1 obtains the sole data of the child to be corrected, and inputs the data into the 3D printing software to obtain the three-dimensional data of the sole of the orthosis; S2 obtains the calf data of the child to be corrected, and loads the data into Magics21 software to obtain the leg data of the orthosis; S3 combines the sole and the leg of the orthosis according to the data in S1 and S2 and using Boolean operation tools; S4 optimizes the combined orthosis and prints the required ankle-foot orthosis through a 3D printer after matching inspection; Among them, the plantar data include the total length of the foot, the total inner length, the total outer length, the toe radius, the inner width, the outer width, the distance from the lowest point of the inner edge of the foot to the midline, the distance from the lowest point of the outer edge of the foot to the midline and the heel radius data. The plantar data is input into the 3D printing insole design software Gensole to obtain the three-dimensional data of the orthotic sole.

2. The method for manufacturing a pediatric ankle-foot orthosis according to claim 1, characterized in that: In the method, when scanning and obtaining calf data, the child takes a standing position, and the calf of the child is scanned using a three-dimensional scanner. During the scanning process, the calf is perpendicular to the surface of the foot, and the sole of the foot faces forward. The scanning time is 0.5-1.5 minutes.

3. The method for manufacturing a pediatric ankle-foot orthosis according to claim 2, characterized in that: In the method, when scanning to obtain calf data, data of the dorsal side of the calf and both sides of the foot are obtained, and the data are processed by 3D Systems Sense software supporting the scanner to generate a three-dimensional data file of the child's calf.

4. The method for manufacturing a pediatric ankle-foot orthosis according to claim 1, characterized in that: In the method, when designing the leg of the orthosis, the scanned calf data is loaded into the Magics21 software, and the overall shell of the calf orthosis is first obtained through the hollow part function. The hollow wall thickness selection range is 2.7-3.5mm, and the multi-segment wire cutting tool is used to remove the unnecessary part of the front of the calf to obtain the leg data of the orthosis.

5. The method for manufacturing a pediatric ankle-foot orthosis according to claim 1, characterized in that: In the method, when combining the sole and leg of the orthosis, the software's translation, rotation, and alignment tools are used to make the designed sole overlap with the sole of the child's foot, and the Boolean operation tool is used to combine the two parts of the sole and the leg guard. Finally, detailed cutting and repair are performed to obtain a static orthosis data model.

6. The method for manufacturing a pediatric ankle-foot orthosis according to claim 5, characterized in that: In the method, a static orthosis data model is obtained and enlarged to wrap the child's calf and be 2-3 mm away from the skin, and 5-10 mm longer than the sole of the foot.

7. The method for manufacturing a pediatric ankle-foot orthosis according to claim 1, characterized in that: In the method, when performing the matching check, the distance between the skin and the orthosis at each angle is observed and measured to see whether it is maintained at 2-3 mm.

8. A pediatric ankle-foot orthosis, characterized in that: It is made by the method according to any one of claims 1 to 7 and is used for ankle and foot orthoses for children.

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