A method for manufacturing a knee-ankle-foot orthosis and the knee-ankle-foot orthosis itself.

Abstract

This application provides a method for manufacturing a knee-ankle-foot orthosis and a knee-ankle-foot orthosis. The method includes: acquiring lower limb scan data including the knee joint; performing three-dimensional reconstruction on the lower limb scan data to generate a three-dimensional data model; generating a knee-ankle-foot orthosis model based on the three-dimensional data model; manufacturing a first part of the knee-ankle-foot orthosis based on the knee-ankle-foot orthosis model, the first part including a first support portion, a second support portion, and a first connecting portion, the first connecting portion being used to connect the first support portion and the second support portion, and the first connecting portion having a first positioning point at the knee joint axis; manufacturing a second part of the knee-ankle-foot orthosis based on the first part of the knee-ankle-foot orthosis, replacing the first connecting portion with the second part to connect the first support portion and the second support portion of the knee-ankle-foot orthosis, thereby obtaining a knee-ankle-foot orthosis that matches the patient's lower limb.

Description

[Technical Field]

[0001] This application relates to the field of medical rehabilitation device technology, and in particular to a method for manufacturing a knee-ankle-foot orthosis and the knee-ankle-foot orthosis itself. [Background Technology]

[0002] Knee-ankle-foot orthosis (KAFO), also known as thigh orthosis, is an orthosis consisting of a structure from the thigh to the foot. It controls the movement of the knee and ankle joints and is used for purposes such as maintaining stability while standing, preventing and correcting deformities without load.

[0003] In the process of manufacturing knee-ankle-foot orthoses, in order to better achieve the expected effect of the orthoses, it is necessary to consider the alignment of the orthoses. Based on the center point of rotation of the patient's knee joint (knee axis), the rotation axis of the mechanical joint axis of the orthoses is determined, so that the two rotation axes are in a suitable, coaxial position.

[0004] In traditional manufacturing processes, a pivot locator is directly inserted into the knee joint of the lower limb plaster model and remains in place until the support strip bending process is completed. This ensures that the rotation axis of the mechanical joint on both sides of the support strip remains unchanged. However, in the design of digital knee-ankle-foot orthoses, computer-aided modeling is used to refine the orthotic model. Only the thigh support and lower leg / foot support parts are printed, while the knee axis is a three-dimensional axis without a physical object. This makes it difficult to ensure the coaxiality of the mechanical joint axis with the human knee joint axis during the subsequent support strip bending process, resulting in an orthotic with unsatisfactory expected results. [Summary of the Invention]

[0005] In view of this, the present application provides a method for manufacturing a knee-ankle-foot orthosis and a knee-ankle-foot orthosis to ensure the coaxiality of the mechanical joint axis and the human knee joint axis, so that the knee-ankle-foot orthosis matches the patient's lower limb.

[0006] To achieve the above objectives, the technical solution of this application is as follows:

[0007] In a first aspect, embodiments of this application provide a method for manufacturing a knee-ankle-foot orthosis, comprising:

[0008] Acquire lower limb scan data, including the knee joint;

[0009] The lower limb scan data is used to perform three-dimensional reconstruction to generate a three-dimensional data model;

[0010] Based on the three-dimensional data model, a knee-ankle-foot orthosis model is generated;

[0011] The first part of the knee-ankle-foot orthosis is fabricated according to the knee-ankle-foot orthosis model. The first part includes a first support part, a second support part, and a first connecting part. The first connecting part is used to connect the first support part and the second support part, and the first connecting part has a first positioning point at the knee joint axis.

[0012] The second part of the knee-ankle-foot orthosis is fabricated based on the first part of the knee-ankle-foot orthosis. The second part includes at least two movable connecting struts, and the movable connection of the two struts is coaxial with the first positioning point. The material of the second part is different from the material of the first connecting part.

[0013] The second part replaces the first connecting part to connect the first support part and the second support part of the knee-ankle-foot orthosis, thus obtaining the knee-ankle-foot orthosis.

[0014] In one implementation of the first aspect, the material of the second part is selected from metal, plastic, wood, and carbon fiber.

[0015] In one implementation of the first aspect, generating a knee-ankle-foot orthosis model based on the three-dimensional data model includes:

[0016] The curves and / or surfaces of the three-dimensional data model are extracted, and the shape of the knee-ankle-foot orthosis model is designed to generate the knee-ankle-foot orthosis model.

[0017] In one implementation of the first aspect, the second support is a split type, including a lower leg support and a foot support, wherein the lower leg support is used to support the lower leg and the foot support is used to support the foot.

[0018] In one implementation of the first aspect, the second support is integral.

[0019] In one implementation of the first aspect, the first part of the knee-ankle-foot orthosis further includes a second connecting part for connecting the lower leg support part and the foot support part, and the second connecting part has a second positioning point at the ankle joint axis.

[0020] In one implementation of the first aspect, both the first support portion and the second support portion are U-shaped structures.

[0021] In one implementation of the first aspect, the first support portion and / or the second support portion are provided with at least one hole.

[0022] In one implementation of the first aspect, the first part is made using 3D printing technology.

[0023] In one implementation of the first aspect, the lower limb scan data includes at least one of the following: knee joint portion, thigh portion, calf portion, foot portion, and ankle joint portion.

[0024] Secondly, embodiments of this application provide a knee-ankle-foot orthosis, which is manufactured according to the manufacturing method of the knee-ankle-foot orthosis as described in the first aspect.

[0025] The technical solution of the method for manufacturing a knee-ankle-foot orthosis provided in this application embodiment involves acquiring lower limb scan data including the knee joint; performing three-dimensional reconstruction on the lower limb scan data to generate a three-dimensional data model; generating a knee-ankle-foot orthosis model based on the three-dimensional data model; manufacturing a first part of the knee-ankle-foot orthosis based on the knee-ankle-foot orthosis model, the first part including a first support portion, a second support portion, and a first connecting portion, the first connecting portion being used to connect the first support portion and the second support portion, and the first connecting portion having a first positioning point at the knee joint axis; manufacturing a second part of the knee-ankle-foot orthosis based on the first part of the knee-ankle-foot orthosis, the second part including at least two movable connecting struts, the movable connection of the two struts being coaxial with the first positioning point, the material of the second part being different from the material of the first connecting portion; replacing the first connecting portion with the second part to connect the first support portion and the second support portion of the knee-ankle-foot orthosis, thereby obtaining the knee-ankle-foot orthosis. In the technical solution provided in this application embodiment, the function of the axis stabilizer is simulated by designing a first connecting part that includes a first positioning point coaxial with the human knee joint axis, thereby ensuring the coaxiality between the mechanical joint axis and the human knee joint axis, and thus producing a knee-ankle-foot orthosis that matches the patient's lower limb. [Attached Image Description]

[0026] To more clearly illustrate the technical solutions of the embodiments of this application, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0027] Figure 1 A flowchart illustrating a method for manufacturing a knee-ankle-foot orthosis according to an embodiment of this application;

[0028] Figure 2 This is a schematic diagram of the structure of a knee-ankle-foot orthosis model provided in one embodiment of this application;

[0029] Figure 3 A schematic diagram of the structure of a knee-ankle-foot orthosis model provided in another embodiment of this application;

[0030] Figure 4 This is a schematic diagram of the structure of a knee-ankle-foot orthosis provided in one embodiment of this application;

[0031] Figure 5 This is a structural schematic diagram of a knee-ankle-foot orthosis provided in another embodiment of this application.

[0032] Figure label:

[0033] 1-Knee-ankle-foot orthotic model; 11-First support part; 12-First connecting part; 121-First positioning point; 13-Second support part; 131-Lower leg support part; 132-Foot support part; 14-Second connecting part; 141-Second positioning point;

[0034] 2-Knee-ankle-foot orthosis; 21-First support part; 22-Strip; 23-First hinge; 231-First positioning point; 24-Second support part; 241-Lower leg support part; 242-Foot support part; 25-Strap; 26-Second hinge; 261-Second positioning point.

[0035] The accompanying drawings, which are incorporated in and form part of this specification, illustrate embodiments consistent with this application and, together with the description, serve to explain the principles of this application.

Detailed Implementation Methods

[0036] To better understand the technical solution of this application, the embodiments of this application will be described in detail below with reference to the accompanying drawings.

[0037] It should be understood that the described embodiments are merely some, not all, of the embodiments in this application. All other embodiments obtained by those skilled in the art based on the embodiments in this application without inventive effort are within the scope of protection of this application.

[0038] The terminology used in the embodiments of this application is for the purpose of describing particular embodiments only and is not intended to be limiting of this application. The singular forms “a,” “the,” and “the” used in the embodiments of this application and the appended claims are also intended to include the plural forms unless the context clearly indicates otherwise.

[0039] It should be understood that the term "and / or" used in this article is merely a description of the relationship between related objects, indicating that three relationships can exist. For example, A and / or B can represent: A existing alone, A and B existing simultaneously, or B existing alone. Additionally, the character " / " in this article generally indicates that the preceding and following related objects have an "or" relationship.

[0040] It should be noted that the directional terms such as "upper," "lower," "left," and "right" described in the embodiments of this application are used to describe the angles shown in the accompanying drawings and should not be construed as limiting the embodiments of this application.

[0041] This application provides a method for manufacturing a knee-ankle-foot orthosis. Figure 1 A flowchart illustrating a method for manufacturing a knee-ankle-foot orthosis provided in this application embodiment is shown below. Figure 1 As shown, the method includes:

[0042] Step 102: Obtain lower limb scan data including the knee joint.

[0043] In one embodiment of this application, at least some steps are performed by a computer device. For example, the computer device includes a computer or a tablet computer.

[0044] In one embodiment of this application, a digital three-dimensional human body scanning system can be used to collect the morphological and dimensional data of a patient's lower limbs to obtain lower limb scanning data, wherein the lower limb scanning data includes at least one of the following: knee joint, thigh, calf, foot, and ankle joint.

[0045] Step 104: Perform three-dimensional reconstruction on the lower limb scan data to generate a three-dimensional data model.

[0046] In one embodiment of this application, a three-dimensional data model is obtained by performing three-dimensional reconstruction based on lower limb scan data including the knee joint.

[0047] Step 106: Generate a knee-ankle-foot orthosis model based on the three-dimensional data model.

[0048] In one embodiment of this application, curves and / or surfaces of a three-dimensional data model are extracted to design the shape of a knee-ankle-foot orthosis model, thereby generating the knee-ankle-foot orthosis model.

[0049] In one embodiment of this application, the knee-ankle-foot orthosis model 1 is a three-dimensional data model. Figure 2 This is a schematic diagram of the structure of a knee-ankle-foot orthosis model provided in one embodiment of this application. Figure 3 A schematic diagram of the structure of a knee-ankle-foot orthosis model provided in another embodiment of this application is shown below. Figure 2 or Figure 3 As shown, the knee-ankle-foot orthosis model 1 includes a first support part 11, a second support part 13, and a first connecting part 12. The first support part 11 is used to support the thigh, the second support part 13 is used to support the lower leg and / or foot, and the first connecting part 12 is used to connect the first support part 11 and the second support part 13. The first connecting part 12 has a first positioning point 121, which is selected from the knee joint axis and is used to mark the human knee joint axis to facilitate the subsequent positioning of the mechanical joint axis.

[0050] The number of first connecting parts 12 can be multiple. As an optional option, the number of first connecting parts 12 is 2.

[0051] Furthermore, such as Figure 3 As shown, the second support part 13 is a split type, which includes a lower leg support part 131 and a foot support part 132. The knee-ankle-foot orthosis model 1 also includes a second connecting part 14, which is used to connect the lower leg support part 131 and the foot support part 132. The second connecting part 14 has a second positioning point 141, which is located at the ankle joint axis and is used to mark the human ankle joint axis to facilitate the subsequent positioning of the mechanical joint axis.

[0052] In one embodiment of this application, whether the second support part 13 is integral or separate can be determined according to the patient's condition, and is not limited here.

[0053] The number of second connecting parts 14 can be multiple. As an optional option, the number of second connecting parts 14 is 2.

[0054] Furthermore, the first support part 11 and the second support part 13 of the knee-ankle-foot orthosis model 1 are both U-shaped structures. For example, the U-shaped structure is a U-shaped semi-enclosed structure. The U-shaped semi-enclosed structure is an ergonomic structure that fits the patient's leg, and the opening part can allow the thigh, calf or foot to be put in, making it convenient for the patient to wear.

[0055] In one embodiment of this application, the first support portion 11 and the second support portion 13 are provided with at least one hole. By providing the hole, not only can the air be breathed and heat dissipated, but the weight can also be reduced, increasing the comfort of the patient wearing it.

[0056] Step 108: Make the first part of the knee-ankle-foot orthosis based on the knee-ankle-foot orthosis model.

[0057] In one embodiment of this application, the first part of the knee-ankle-foot orthosis includes: a first support part, a second support part, and a first connecting part, wherein the first connecting part is used to connect the first support part and the second support part, and the first connecting part has a first positioning point at the knee joint axis.

[0058] In one embodiment of this application, the knee-ankle-foot orthosis model undergoes data format conversion, such as conversion to stereolithography (STL), polygon file format (PLY), or virtual reality language (WRL) format—formats recognizable by slicing software. The model is then sliced ​​using slicing software to obtain layer image data. This layer image data is processed to obtain layer printing data representing the knee-ankle-foot orthosis. The layer printing data includes information representing the object's shape and / or information representing the object's color. Finally, the knee-ankle-foot orthosis model is printed layer by layer using 3D printing technology to obtain the first part of the knee-ankle-foot orthosis. Exemplary 3D printing technologies that may be used include, but are not limited to, stereolithography (SLA), digital light processing (DLP), 3-D printing (3DP), multi-jet fusion (MJF), and various other types of 3D printing or additive manufacturing technologies known in the art, which are not limited herein.

[0059] Step 110: Make the second part of the knee-ankle-foot orthosis based on the first part of the knee-ankle-foot orthosis.

[0060] In one embodiment of this application, the material of the second part of the knee-ankle-foot orthosis is different from the material of the first connecting part. The material of the second part is selected from metal, plastic, wood, carbon fiber, etc. The strength of the material of the second part is higher than that of the material of the first connecting part, which can meet the needs of patients. It can be selected according to the actual situation and is not limited here.

[0061] In one embodiment of this application, the second part of the knee-ankle-foot orthosis includes at least two movable connecting struts, and the movable connection of the two struts is coaxial with the first positioning point.

[0062] Specifically, the second part of the knee-ankle-foot orthosis is made according to the first part of the knee-ankle-foot orthosis, wherein one support bar is bent according to the shape of the first support part, and the other support bar is bent according to the shape of the second support part. The two support bars are movably connected by a first hinge, and the movable connection of the two support bars is coaxial with the first positioning point.

[0063] Step 112: Replace the first connecting part with the second part to connect the first support part and the second support part of the knee-ankle-foot orthosis, thereby obtaining the knee-ankle-foot orthosis.

[0064] One embodiment of this application provides a knee-ankle-foot orthosis, which is manufactured according to the above-described method for manufacturing knee-ankle-foot orthoses.

[0065] Figure 4 This is a schematic diagram of the structure of a knee-ankle-foot orthosis provided in one embodiment of this application. Figure 5 A schematic diagram of the structure of a knee-ankle-foot orthosis provided in another embodiment of this application is shown below. Figure 4 , Figure 5 As shown, replace the support 22 with the first hinge 23. Figure 2 or Figure 3 The first connecting part 12 and the lower left and right sides of the first support part 21 are fixedly connected to one end of the support bar 22, respectively. The upper left and right sides of the second support part 24 are fixedly connected to one end of another support bar 22, respectively. The other ends of the two support bars 22 on the same side that are not fixedly connected are respectively connected to the first hinge 23. The first hinge 23 is coaxial with the first positioning point 231 to ensure the coaxiality of the mechanical joint axis of the knee-ankle-foot orthosis 2 with the human joint axis. The first hinge 23 can move coaxially with the rotation center of the human knee joint, and can make a knee-ankle-foot orthosis 2 that matches the patient.

[0066] Among them, according to such Figure 2 or Figure 3 The first support part 11 shown is manufactured Figure 4 or Figure 5 The first support part 21 in the middle; according to as follows Figure 2 or Figure 3 The second support part 13 shown is manufactured Figure 4 or Figure 5 The second support part 24 in the middle; such as Figure 2 or Figure 3 The first positioning point 121 shown is Figure 4 or Figure 5 The first positioning point 231 is the same.

[0067] Furthermore, such as Figure 5 As shown, in Figure 4 Based on the previous embodiment, the second support part 24 is a split type, including a lower leg support part 241 and a foot support part 242, and the second hinge 26 is replaced. Figure 2 or Figure 3 The lower left and right sides of the lower part of the second connecting part 14 of the lower leg support part 241 are fixedly connected to the second hinge 26 respectively, and the upper left and right sides of the foot support part 242 are movably connected to the second hinge 26 respectively. The movable connection between the foot support part 242 and the second hinge 26 is coaxial with the second positioning point 261, ensuring the coaxiality of the mechanical joint axis of the knee-ankle-foot orthosis 2 with the human joint axis. The foot support part 242 can move coaxially with the rotation center of the human ankle joint, and a knee-ankle-foot orthosis 2 that matches the patient can be made.

[0068] Among them, according to such Figure 3 Fabrication of the lower leg support 131 shown Figure 5 The lower leg support part 241; according to as follows Figure 3 The foot support part 132 shown is manufactured. Figure 5 Foot support portion 242; such as Figure 3 The second positioning point 141 shown is Figure 5 The second positioning point 261 is the same.

[0069] The patient can put on the knee-ankle-foot orthosis 2 from the back of the thigh and calf, with the thigh inside the first support part 21 and the calf and foot inside the second support part 24. Then, the straps 25 on the first support part 21 and the second support part 24 are tightened to secure the patient's lower limbs. For better binding effect, the straps 25 can be elastic nylon fasteners secured by buckles, or they can be adhesive strips secured by snap fasteners; the method is not limited here.

[0070] The technical solution provided in this application involves acquiring lower limb scan data including the knee joint; performing three-dimensional reconstruction on the lower limb scan data to generate a three-dimensional data model; generating a knee-ankle-foot orthosis model based on the three-dimensional data model; fabricating a first part of the knee-ankle-foot orthosis based on the knee-ankle-foot orthosis model, the first part including a first support part, a second support part, and a first connecting part, the first connecting part being used to connect the first support part and the second support part, and the first connecting part having a first positioning point at the knee joint axis; fabricating a second part of the knee-ankle-foot orthosis based on the first part of the knee-ankle-foot orthosis, the second part including at least two movable connecting struts, the movable connection of the two struts being coaxial with the first positioning point, the material of the second part being different from the material of the first connecting part; replacing the first connecting part with the second part to connect the first support part and the second support part of the knee-ankle-foot orthosis, thereby obtaining the knee-ankle-foot orthosis. In the technical solution provided in this application embodiment, the function of the axis stabilizer is simulated by designing a first connecting part that includes a first positioning point coaxial with the human knee joint axis, thereby ensuring the coaxiality between the mechanical joint axis and the human knee joint axis, and thus producing a knee-ankle-foot orthosis that matches the patient's lower limb.

[0071] The method for manufacturing a knee-ankle-foot orthosis provided in this application embodiment simulates the function of a pivot by designing a first connecting part that includes a first positioning point coaxial with the human knee joint axis. The pivot of the mechanical joint axis of the support is determined according to the position of the first positioning point, ensuring the coaxiality between the mechanical joint axis and the human knee joint axis, improving the manufacturing accuracy, and enabling the manufactured knee-ankle-foot orthosis to better achieve the expected effect.

[0072] The above description is merely a preferred embodiment of this application and is not intended to limit this application. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the scope of protection of this application.

Claims

1. A manufacturing method of a knee-ankle-foot orthosis, characterized by, include: Acquire lower limb scan data, including the knee joint; The lower limb scan data is used to perform three-dimensional reconstruction to generate a three-dimensional data model; Based on the three-dimensional data model, a knee-ankle-foot orthosis model is generated; The first part of the knee-ankle-foot orthosis is fabricated according to the knee-ankle-foot orthosis model. The first part includes a first support part, a second support part, and a first connecting part. The first connecting part is used to connect the first support part and the second support part, and the first connecting part has a first positioning point at the knee joint axis. The second part of the knee-ankle-foot orthosis is fabricated based on the first part of the knee-ankle-foot orthosis. The second part includes at least two movable connecting struts, and the movable connection of the two struts is coaxial with the first positioning point. The material of the second part is different from the material of the first connecting part. The second part replaces the first connecting part to connect the first support part and the second support part of the knee-ankle-foot orthosis, thus obtaining the knee-ankle-foot orthosis.

2. The method of claim 1, wherein, The materials for the second part are selected from metal, plastic, wood, and carbon fiber.

3. The method according to claim 1, characterized in that, The step of generating a knee-ankle-foot orthosis model based on the three-dimensional data model includes: The curves and / or surfaces of the three-dimensional data model are extracted, and the shape of the knee-ankle-foot orthosis model is designed to generate the knee-ankle-foot orthosis model.

4. The method according to claim 1, characterized in that, The second support part is a split type, including a lower leg support part and a foot support part. The lower leg support part is used to support the lower leg, and the foot support part is used to support the foot.

5. The method according to claim 1, characterized in that, The second support is a single piece.

6. The method according to claim 4, characterized in that, The first part of the knee-ankle-foot orthosis further includes a second connecting part for connecting the lower leg support part and the foot support part, and the second connecting part has a second positioning point at the ankle joint axis.

7. The method according to claim 1, characterized in that, Both the first support portion and the second support portion are U-shaped structures.

8. The method according to claim 1, characterized in that, The first support portion and / or the second support portion are provided with at least one hole.

9. The method according to claim 1, characterized in that, The first part was made using 3D printing technology.

10. The method according to claim 1, characterized in that, The lower limb scan data includes at least one of the following: knee joint, thigh, calf, foot, and ankle joint.

11. A knee-ankle-foot orthosis, characterized in that, The knee-ankle-foot orthosis is manufactured according to the method for manufacturing a knee-ankle-foot orthosis as described in any one of claims 1-10.

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