Manufacturing method for body-worn devices

Abstract

When using a 3D printer to provide prosthetic limbs, orthotic devices, or parts thereof, the delivery time will be reduced. [Solution] A method for manufacturing a body-worn device is provided, comprising: a test device manufacturing step of manufacturing a test device, which is a prosthesis, orthosis, or a part thereof, used for test fitting to the body, using a 3D printer; an adjustment step of performing a test fitting to the body using the test device and making adjustments to the test device according to the results of the test fitting; and a reinforcement step of reinforcing the adjusted test device to make it a final device.

Description

Technical Field

[0001] The present invention relates to devices worn on the body including prostheses, orthoses or parts thereof, and methods for manufacturing them.

Background Art

[0002] In recent years, attempts have been made to manufacture devices worn on the body including prostheses, orthoses or parts thereof (for example, prosthetic sockets) using a three-dimensional printer (3D printer) (Patent Document 1).

Prior Art Documents

Patent Documents

[0003]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0004] By the way, for example, the creation of a prosthesis using a 3D printer is generally performed in the following procedure. First, a 3D model that fits the stump end is created based on the shape of the stump end of the subject scanned through a 3D scanner or the like. Next, a test socket is manufactured by 3D printing the created 3D model. The manufacturer performs a fitting operation on the stump end using this test socket, and makes adjustments to the test socket through this fitting operation. For example, fine adjustments regarding the shape and alignment adjustments, that is, adjustments of the position and angle between the test socket and other prosthetic parts such as joints are performed. Finally, based on this alignment information, a high-strength prosthetic socket used by the prosthesis user is manufactured with a 3D printer, and the prosthetic socket is combined with other prosthetic parts to form the final prosthesis.

[0005] In other words, the manufacturing process for prosthetic sockets previously involved two 3D printing processes: a first, simplified 3D print to produce a test socket (test device), and a second, post-fitting 3D print to produce a high-strength socket (final device) that would ultimately be provided to the user.

[0006] However, because the final prosthetic socket requires a certain level of strength, this second 3D printing process took significantly longer than the first. For example, in the case of a prosthetic socket for a lower leg prosthesis, the manufacturing time for a test socket is approximately one hour, while the manufacturing time for the final socket can be approximately eight hours. This time difference is due to factors such as the thickness and the presence or absence of reinforcing structures during 3D printing. Therefore, shortening the delivery time for prosthetics using 3D printers is not easy, making it difficult to provide users with a final prosthetic that can be used immediately, for example, on the same day the mold is taken.

[0007] The above circumstances also apply to orthotic devices to which similar manufacturing processes are applied.

[0008] This invention has been made in view of the above-mentioned technical background, and its purpose is to shorten the delivery time when providing prosthetic limbs, orthotic devices, or parts thereof using a 3D printer. [Means for solving the problem]

[0009] The technical problems described above can be solved by a method for manufacturing a body-worn device having the following configuration.

[0010] In other words, the method for manufacturing a body-worn device according to the present invention includes a test device manufacturing step of manufacturing a test device, which is a prosthesis, orthosis, or a part thereof, used for test fitting to the body, using a three-dimensional printer; an adjustment step of performing a test fitting to the body using the test device and making adjustments to the test device according to the results of the test fitting; and a reinforcement step of reinforcing the adjusted test device to make it a final device.

[0011] With this configuration, the final device can be created by reinforcing the test device that has been adjusted through test fitting. Therefore, when providing prosthetics, orthotics, or parts thereof (such as sockets) using a 3D printer, the delivery time can be shortened.

[0012] The reinforcement step may further include a reinforcement placement step, which involves placing reinforcing material on part or all of the outer surface of the test device to obtain the final device.

[0013] This configuration allows for appropriate reinforcement while maintaining the shape of the inner surface that comes into contact with the body.

[0014] The thickness of the reinforcing material may be greater than the thickness of the test device.

[0015] This configuration allows for a reduction in the thickness of the test device, thereby shortening the manufacturing time of the test device. Furthermore, since the reinforcing material is generally less expensive than the resin used in 3D printing, manufacturing costs can also be reduced.

[0016] The test device is a test socket, which is a prosthetic socket for test fitting, and the adjustment step may further include an alignment adjustment step of performing the test fitting using the test socket and adjusting the alignment between the test socket and the test prosthetic components.

[0017] With this configuration, the final device can be created by reinforcing the test socket after test fitting, particularly after alignment adjustment. Therefore, when providing a prosthesis or a part thereof using a 3D printer, it is possible to shorten the delivery time and provide a device that provides a suitable fit to the body.

[0018] The reinforcement step may further include an assembly construction step of connecting a connecting member, which is interposed between the final prosthetic component to be ultimately used and the test socket and connects them to match the result of the alignment adjustment, to the test socket to form an assembly, and an assembly reinforcement step of obtaining the final device by fixing the reinforcing material to at least a part or all of the outer surface of the assembly.

[0019] With this configuration, by reinforcing the outer surface of the test socket for test fitting while it is connected to the connecting member, a high-strength final socket that can be attached to prosthetic components can be obtained.

[0020] The reinforcing material may be fixed by lamination techniques.

[0021] With this configuration, reinforcing materials can be fixed in layers across the entire outer surface of the aggregate, making it possible to manufacture a lightweight yet high-strength socket.

[0022] The laminated material used in the aforementioned lamination technique may be an expandable material.

[0023] According to such a configuration, the laminate can be steadily adhered along the surface of the assembly.

[0024] The stretchable material may be a stocking net.

[0025] According to such a configuration, lamination can be easily performed using a common stocking net.

[0026] The laminate may be made of nylon, glass fiber or carbon fiber.

[0027] According to such a configuration, a material suitable for holding the resin can be used, so that the strength of the final socket can be improved.

[0028] The reinforcing step may further include an attaching step of attaching a reinforcing tape to a part of the assembly, and the fixing of the reinforcing material may be performed by overlapping the reinforcing tape.

[0029] According to such a configuration, the strength of the final socket can be further improved.

[0030] The reinforcing tape may be a carbon tape.

[0031] According to such a configuration, the strength of the final socket can be further improved with a carbon tape having high strength, light weight and flexibility.

[0032] The reinforcing tape may be attached to the outer periphery near the opening at the proximal end of the test socket.

[0033] According to such a configuration, deformation can be suppressed by attaching to a portion that can elastically deform when the test socket is mounted, and the strength of the final socket can be improved.

[0034] The reinforcing tape may be attached to the joint between the test socket and the connecting member.

[0035] With this configuration, the strength of the final socket can be improved by reinforcing the joints, which are structurally prone to losing strength.

[0036] The reinforcing tape may be attached to the distal end face of the connecting member.

[0037] With this configuration, the distal end of the connecting member, where loads and moments are generated, is reinforced when the connecting member and the final prosthetic limb component come into contact, thereby improving the strength of the final socket.

[0038] The distal end face of the connecting member may be provided with a groove corresponding to the thickness of the reinforcing tape.

[0039] With this configuration, the thickness of the distal end of the connecting member can be suppressed.

[0040] The connecting member may be 3D modeled based on the results of the alignment adjustment and manufactured by a 3D printer.

[0041] With this configuration, a coupling member can be obtained that connects the final prosthetic component and the test socket to match the result of the alignment adjustment.

[0042] The connecting member may be one of several connecting members of different shapes that have been prepared in advance.

[0043] With this configuration, connecting members can be obtained quickly, and the time required to provide the prosthetic socket and, consequently, the prosthetic limb can be further reduced.

[0044] The coupling member may have a recess on its proximal end face that conforms to the shape of the distal end of the test socket.

[0045] This configuration allows for a high-strength connection between the test socket and the coupling member.

[0046] The test socket and the connecting member may be joined together by an adhesive.

[0047] This configuration allows for easier and more secure connection between the test socket and the coupling member.

[0048] The final prosthetic component may be an adapter having a first hole, and the distal end face of the final device may have a second hole that penetrates the connecting member and the reinforcing material, the second hole may be secured by inserting a dummy bolt into the second hole of the connecting member when performing the lamination technique, and the adapter and the final device may be fixed together by inserting bolts through the first hole and the second hole.

[0049] With this configuration, even when lamination is used, it is possible to ensure compatibility with adapters using bolts.

[0050] The aforementioned 3D printer may be a stacked 3D printing device.

[0051] With this configuration, the resin involved in lamination adheres to the lamination marks on the surface of the test socket, resulting in a strong bond between the test socket and the resin. [Effects of the Invention]

[0052] According to the present invention, when providing prosthetic limbs, orthotic devices, or parts thereof using a 3D printer, the time required for provision can be shortened. [Brief explanation of the drawing]

[0053] [Figure 1] Figure 1 is an overall diagram of the prosthetic leg manufacturing system. [Figure 2] Figure 2 is a detailed configuration diagram of the information processing device. [Figure 3] Figure 3 is a flowchart showing the manufacturing method of a prosthetic leg. [Figure 4] Figure 4 shows the appearance of an example of a designed test socket. [Figure 5] Figure 5 shows an example of a designed test socket, viewed from the distal end. [Figure 6] Figure 6 is an external perspective view of an example of a designed connecting member. [Figure 7] Figure 7 is a longitudinal cross-sectional view of the designed connecting member, cut near the center. [Figure 8] Figure 8 is a perspective view of the bottom surface of the connecting member. [Figure 9] Figure 9 is an external view of the assembled test socket and coupling member. [Figure 10] Figure 10 is an external view of the composite structure after plaster has been poured in and reinforced. [Figure 11] Figure 11 shows a state in which the coupling adapter is fixed to the distal end or tip of the final socket. [Figure 12] Figure 12 shows the test socket connected to a pre-prepared coupling member. [Modes for carrying out the invention]

[0054] Hereinafter, preferred embodiments of the present invention will be described in detail with reference to the attached drawings.

[0055] (1. First Embodiment) As a first embodiment, an example of applying the present invention to a prosthetic leg or a part thereof, specifically to a manufacturing system and manufacturing method, will be described. In this embodiment, a lower leg prosthesis will be described as an example, but the invention can also be applied to other prosthetic limbs. Therefore, it may be applied to prosthetic legs used in other parts of the body, for example, transfemoral prostheses, or to prosthetic limbs applied to other limbs such as prosthetic hands and fingers. Furthermore, the present invention may also be applied to orthotic devices or a manufacturing system and manufacturing method for a part thereof.

[0056] (1.1 Configuration of the prosthetic leg manufacturing system) Figure 1 is an overall configuration diagram of the prosthetic leg manufacturing system 100 according to this embodiment. As is clear from the figure, the prosthetic leg manufacturing system 100 includes an information processing device 10. A 3D scanner 20, a 3D printer 30, an input device 40, and a display device 50 are connected to the information processing device 10.

[0057] The information processing device 10 is, for example, an information processing device such as a PC (personal computer). The 3D scanner 20 is a scanning device for performing 3D measurement of an object. The 3D printer 30 is a 3D printing device that performs 3D printing based on a 3D model generated by the information processing device 10, etc. In this embodiment, as an example, an FDM (Fused Deposition Modeling) type 3D printing device is used. The input device 40 is various input devices such as a mouse and a keyboard. The display device 50 is a device that presents information through visual means such as a display.

[0058] Figure 2 is a detailed configuration diagram of the information processing device 10. As is clear from the figure, the information processing device 10 comprises a processor 11, a storage unit 12, a communication unit 13, a display control unit 15, and an I / O processing unit 16. The processor 11 is an arithmetic unit such as a CPU, which executes programs to realize various operations described later. The storage unit 12 is a storage medium (including non-temporary computer-readable storage medium) such as ROM / RAM, flash memory, or hard disk, which stores programs and data to realize various operations described later. The communication unit 13 is a communication unit that enables the exchange of information with external devices. The display control unit 15 performs processing to control image information and the like that is displayed on the display device 50. The I / O processing unit 16 processes input and output signals with external devices.

[0059] Note that the hardware and network configurations are not limited to those according to this embodiment. Therefore, other configurations may be adopted; for example, it may be configured as a server-client system, or a separate server may be provided for storing and providing data.

[0060] Furthermore, in this embodiment, the computer program may be provided as a computer program product or as a recording medium for storing the computer program.

[0061] (1.2 Method of manufacturing prosthetic limbs) Next, the method for manufacturing a prosthetic leg, particularly a lower leg prosthesis, using the prosthetic leg manufacturing system 100 will be described in order below.

[0062] Figure 3 is a flowchart illustrating the manufacturing method of a prosthetic leg. As is clear from the figure, in this embodiment, the worker manufacturing the prosthetic leg first designs a test socket 60 based on the shape of the stump of the lower leg (S11). In this embodiment, the shape of the stump of the lower leg is acquired by 3D scanning the stump using a 3D scanner 20 and stored in the information processing device 10. Note that the acquisition of the stump shape may be carried out by other methods. For example, the stump may be physically measured.

[0063] Furthermore, in this embodiment, the design of the test socket 60 is performed on the information processing device 10 using machine learning technology. That is, based on a trained model, a 3D test socket shape that fits the stump is generated from the 3D stump shape obtained using the 3D scanner 20. Note that the test socket design method is not limited to this configuration. For example, an operator may design a 3D test socket shape that fits the stump using 3D CAD, or machine learning and 3D CAD may be used in combination.

[0064] Figure 4 shows the appearance of an example of a designed test socket 60. Figure (A) is a front view of the test socket 60, and Figure (B) is a side view of the test socket 60. As is clear from the figure, the test socket 60 has a rectangular projection 61 at its distal end (or tip). This projection 61 provides a reference for the position and orientation of the test socket 60. In addition, a reinforced portion 63 with increased thickness is provided at the proximal end (or opening edge) on the dorsal side of the test socket 60. This reinforced portion 63 protrudes slightly radially outward. Furthermore, a recess 62 is provided on the front side of the test socket 60 at a position corresponding to the patellar tendon.

[0065] Figure 5 shows an example of a designed test socket 60, viewed from the distal end. Figure (A) is a bottom view of the test socket 60, and Figure (B) is a perspective view of the test socket 60 viewed from the distal end. As is clear from the figure, the projection 61 has a rectangular cross-section.

[0066] Returning to Figure 3, the designed test socket 60 is 3D printed by the 3D printer 30 and used for fitting to the stump (S12). The test socket 60 is used for fitting to the stump. At this time, the 3D printing time for the test socket 60 is, for example, about 2 hours, and its strength is sufficient to withstand fitting. This time is in contrast to the conventional final socket printing time, which takes several times longer.

[0067] Fitting is the process of having the prosthetic leg user actually wear the test socket 60 and performing alignment adjustments. Alignment adjustment is the process of adjusting the relative position and angle of the test prosthetic component (for example, a coupling adapter attached to the prosthetic leg socket, a metal pipe attached to the coupling adapter, or a foot attached to the other end of the metal pipe). As a result of the fitting, alignment information is obtained using a 3D scanner 20 or an angle meter, etc.

[0068] Furthermore, during this fitting process, the shape of the test socket 60 may be physically modified by filing down a portion of it. This can result in a prosthetic socket with a more preferable fit.

[0069] After fitting, the operator designs a coupling member 70 (or connector) that matches the shape of the test socket 60 using 3D CAD or the like on the information processing device 10 to reproduce the obtained alignment information, and outputs it in 3D using the 3D printer 30 (S13). Note that the means for generating the shape of the coupling member 70 is not limited to 3D CAD. For example, instead of 3D CAD, or together with 3D CAD, a trained model that outputs the optimal coupling member 70 shape from the alignment information and the shape of the test socket 60 may be used.

[0070] Figure 6 is an external perspective view (part 1) of an example of the designed coupling member 70. As is clear from the figure, the top surface of the coupling member 70 is provided with a recess 71 for joining with the test socket 60. The recess 71 is provided with a curved surface that follows the curved surface near the distal end of the test socket 60, and a non-through hole 711 with a square cross-section into which a projection 61 with a square cross-section can be inserted.

[0071] Furthermore, as is clear from the figure, the cross-section of the bottom surface of the connecting member 70 is a roughly square shape with rounded corners, and one through-hole 710 is provided at each corner through which a bolt can be inserted. In addition, a cross-shaped groove 72 is provided on the bottom surface.

[0072] Figure 7 is a longitudinal cross-sectional view of the designed coupling member 70 cut near the center. As is clear from the figure, the coupling member 70 has a recess 71 that can be joined to the distal end of the test socket 60, and a non-through hole 711 is provided at the bottom center.

[0073] Figure 8 is a perspective view of the bottom surface of the connecting member 70. As is clear from the figure, the bottom surface has one through hole 710 at each of the four corners, and a cross-shaped groove 72. As will be described later, the depth of this groove 72 is approximately equal to or approximately equal to the thickness of the carbon tape 85.

[0074] With this configuration, the thickness of the distal end of the connecting member 70 caused by the reinforcing tape such as carbon tape 85 can be suppressed.

[0075] Returning to Figure 3, once the output of the connecting member 70 is complete, the operator combines the 3D printed connecting member 70 with the 3D printed test socket 60 to form an integrated body (S15).

[0076] Figure 9 is an external view of the assembled body of the test socket 60 and the connecting member 70. Figure (A) is a front view of the assembled body, and Figure (B) is a left side view of the assembled body. As is clear from the figure, the test socket 60 and the connecting member 70 are joined by inserting a square-shaped projection 61 located at the distal end or tip of the test socket 60 into a square-shaped non-through hole 711 of the connecting member 70, and by bringing the curved surface near the distal end or tip of the test socket 60 into contact with the curved surface of the connecting member 70. At this time, the test socket 60 and the connecting member 70 are bonded together with an adhesive.

[0077] Furthermore, as is clear from the figure, in this embodiment, the coupling member 70 is designed taking into account the shape of the test socket 60, so the outer surface of the test socket 60 and the outer surface of the coupling member 70 are smoothly or continuously connected.

[0078] This configuration allows for the avoidance of stress concentration and other issues, further improving the strength of the final socket.

[0079] Returning to Figure 3, after joining the test socket 60 and the connecting member 70 to form an aggregate, the worker pours plaster 82 into the test socket 60 and allows it to solidify, as a preliminary step to the lamination process described later, and also reinforces the test socket 60 (S16).

[0080] By pouring gypsum 82 into the interior of the test socket 60 and allowing it to solidify, it is possible to prevent resins and other materials related to the lamination process from reaching the interior of the test socket 60. This prevents, for example, changes in the internal shape of the surface that comes into contact with the body. Furthermore, to prevent resin from seeping between the gypsum and the test socket 60, a means to prevent resin from flowing in may be placed at the proximal edge (trimming line) of the test socket 60. As a means to prevent resin from flowing in, for example, carbon tape, clay, or adhesives that harden with heat or steam can be used.

[0081] In this embodiment, the test socket 60 is reinforced using carbon tape (83, 84, 85). However, the reinforcement method is not limited to this, and other methods may be used. Furthermore, if the plaster 82 comes into direct contact with the three-dimensionally printed test socket 60, final removal may become difficult. Therefore, a vinyl sheet may be placed between the test socket 60 and the plaster 82 (not shown).

[0082] Figure 10 is an external view of the assembled body reinforced with plaster 82. Figure (A) is a front view of the assembled body, and Figure (B) is a left side view of the assembled body. As is clear from the figure, plaster 82 is poured into the inside of the test socket 60 and solidified into a columnar shape. A metal pipe 81 is fixed to the center of the top surface of the plaster 82. This metal pipe 81 fixes the position of the assembled body.

[0083] The first carbon tape 83 is attached at least once around the outer circumference near the opening at the proximal end of the test socket 60 of the composite body.

[0084] With this configuration, deformation can be suppressed by applying carbon tape 83 to parts that may elastically deform when the test socket 60 is installed, thereby improving the strength of the final socket 90.

[0085] Furthermore, a second carbon tape 84 is attached at least once around the outer circumference of the joint between the test socket 60 and the connecting member 70.

[0086] With this configuration, the strength of the final socket 90 can be improved by reinforcing the joints, which are structurally prone to losing strength.

[0087] Furthermore, a third carbon tape 85 is attached in a cross shape to the bottom surface or distal end surface of the connecting member 70.

[0088] With this configuration, the distal end of the connecting member 70, where it comes into contact with other prosthetic components and generates loads and moments, is reinforced, thereby improving the strength of the final socket 90.

[0089] Returning to Figure 3, once the reinforcement treatment of the composite is complete, the worker performs lamination on the reinforced composite. After this lamination, the gypsum 82 is removed (S17). In this embodiment, the lamination process includes covering the outer surface of the composite with a laminate and a film, then creating a vacuum inside the film, impregnating it with liquid resin, and then curing it.

[0090] With this configuration, reinforcing materials can be fixed in layers across the entire outer surface of the aggregate, making it possible to manufacture a lightweight yet high-strength socket.

[0091] In this embodiment, the thickness of the reinforcing material is greater than the thickness of the corresponding portion of the test socket 60.

[0092] This configuration allows for a reduction in the thickness of the test socket 60, thereby shortening the manufacturing time of the test socket 60. Furthermore, since the price of reinforcing materials is generally lower than the price of resin used in 3D printing, manufacturing costs can also be reduced.

[0093] Alternatively, the thickness of the test socket 60 can be made thicker beforehand, and the thickness of the reinforcing material can be made smaller than the thickness of the test socket 60. In this case, the reinforcing material may be placed or fixed to the entire outer surface by thin lamination, or the reinforcing material may be placed only on a part of the outer surface where localized loads are applied. Reinforcement methods for localized reinforcement will be described later.

[0094] In this embodiment, since an FDM-type 3D printing device is used, layer lines are present on the surface of the test socket 60. These layer lines make it easier for the resin used in the lamination process to adhere to the test socket 60, thus enabling a strong bond between the resin and the test socket 60.

[0095] In this case, the layer height and line width may be adjusted to achieve an even stronger bond between the lamination resin and the test socket 60. For example, by increasing the layer height or decreasing the line width, the void space may be increased, and the lamination resin may be filled into this void space to achieve an even stronger bond between the lamination resin and the test socket 60.

[0096] In this embodiment, stockinette made of a stretchable fabric material such as cotton or acrylic is used as the laminate.

[0097] With this configuration, the laminated material can be firmly attached to the surface of the aggregate by utilizing its elasticity. Furthermore, lamination can be easily carried out using readily available stockinette.

[0098] Other materials may be used as the laminated material; for example, nylon material, glass fiber, or carbon fiber may be used.

[0099] With this configuration, a material suitable for holding the resin can be used, and the strength of the final socket can be improved.

[0100] This lamination process is carried out with dummy bolts inserted into the through holes 710 of the connecting member 70.

[0101] With this configuration, by removing the dummy bolts after lamination, it is possible to ensure bolt-based connectivity with other prosthetic components, such as coupling adapters.

[0102] After the removal of the plaster 82, the worker connects the laminated assembly, i.e., the final socket 90, with other prosthetic leg components, such as a coupling adapter attached to the socket, a metal pipe attached to the coupling adapter, or a foot attached to the other end of the metal pipe, to assemble the final prosthesis (S18). After this assembly is complete, the manufacturing method of the prosthesis is finished. Note that the test prosthetic limb components used during test fitting may be different from or the same as the final prosthetic leg components.

[0103] Figure 11 shows a state in which a coupling adapter 92 is fixed to the distal end or tip of a laminated final socket 90 via four bolts and nuts (not shown in the figure). In this figure, the coupling member 70 inside the final socket 90 and the coupling adapter 92 are fixed with bolts.

[0104] With the above configuration, the test device (test socket 60) adjusted by test fitting can be reinforced to become the final device (final socket 90), thus shortening the delivery time when providing a prosthesis or a part thereof using a 3D printer.

[0105] Furthermore, by reinforcing the test socket after test fitting, particularly after alignment adjustment, it can be made into the final device (final socket 90). Therefore, when providing a prosthesis or a part thereof using a 3D printer, it is possible to shorten the delivery time and provide a device that provides a suitable fit to the body.

[0106] Furthermore, by reinforcing the outer surface of the test socket 60 for test fitting while it is connected to the connecting member 70, a high-strength final socket 90 that can be attached to prosthetic components can be obtained. This eliminates the need for further 3D printing to obtain a high-strength socket, and in the process of providing prosthetic sockets using a 3D printer, the time required to provide the prosthetic socket, and consequently the prosthesis, can be shortened.

[0107] (2. Variant) The present invention can be implemented in various modified forms.

[0108] In the above-described embodiment, the coupling member 70 was designed using 3D CAD or the like on the information processing device 10 based on the obtained alignment information and output in 3D by the 3D printer 30 (S13). However, the present invention is not limited to such a configuration. Therefore, for example, multiple coupling members that provide different alignments may be prepared in advance, and one of them may be selected and used according to the obtained alignment information.

[0109] Figure 12 shows a state in which a test socket 60' is connected to a pre-prepared connecting member 75. In the example shown, the top surface of the connecting member 75, whose connection angle with other parts is predetermined, is connected to the distal end of the test socket 60'. The connection method may be a fit, or additional connection methods such as adhesive may be used.

[0110] With this configuration, connecting members can be obtained quickly, and the time required to provide the prosthetic socket and, consequently, the prosthetic limb can be further reduced.

[0111] In the embodiments described above, lamination techniques were used as a means of reinforcing the outer surface of the test socket or composite, but the present invention is not limited to such configurations. As long as the strength of the test socket or composite can be improved, for example, instead of lamination, or in conjunction with lamination, a material such as a resin-impregnated glass mat may be laminated onto the test socket or composite and cured (hand lay-up molding). Alternatively, a strip of casting tape moistened with water may be wrapped around the test socket or composite, dried, and fixed in place. Furthermore, the strength may be improved by fixing the test socket 60 or composite inside, for example, the inside of a shell-structure prosthesis, for example, inside the pipe portion (for example, the outer pipe made of polyvinyl chloride (PVC) or high-density polyethylene (HDPE) of a shell-structure prosthesis for the lower leg).

[0112] In the embodiments described above, the entire outer surface of the test socket or assembly was reinforced, but the present invention is not limited to such a configuration. Therefore, localized reinforcement may be applied to only a portion of the outer surface of the test socket or assembly. For example, the test socket may be manufactured thicker, and reinforcement may be applied only to the areas where localized strength is required.

[0113] In this case, various known methods can be employed as reinforcement means. For example, a material such as a glass mat impregnated with resin may be laminated onto a part of the test socket or assembly and then cured (hand lay-up molding). Alternatively, another test socket may be fixed along the outer surface of the test socket or assembly to create a double-layered structure on a part of the outer surface.

[0114] Although embodiments of the present invention have been described above, these embodiments represent only a part of the application examples of the present invention, and are not intended to limit the technical scope of the present invention to the specific configurations of the above embodiments. Furthermore, the above embodiments can be combined as appropriate, as long as no contradictions arise. [Industrial applicability]

[0115] This invention can be used in industries that manufacture prosthetic limbs and the like. [Explanation of Symbols]

[0116] 10 Information Processing Devices 11 processors 12 Storage section 13 Communications Department 15 Display Control Unit 16 I / O Processing Unit 20 3D scanners 30 3D printers 40 Input devices 50 Display device 60 Test Sockets (First Embodiment) 60' Test Socket (Variation) 61 Protrusion 62 indentation 63 Reinforcement section 70 Connecting member (first embodiment) 71 recess 710 Through hole 711 Non-through hole section 72 groove (cruciform) 75 Connecting member (modified version) 81 Metal pipe 82 Plaster 83. First carbon tape 84. Second carbon tape 85. Third carbon tape 90 Final Socket 92 Coupling Adapter

Claims

1. A test device manufacturing step involves manufacturing a prosthesis, orthosis, or a test device that is a part thereof, used for test fitting to the body, using a 3D printer. An adjustment step is to perform a test fitting on the body using the test device and make adjustments to the test device according to the results of the test fitting. A method for manufacturing a body-worn device, comprising a reinforcement step of reinforcing the adjusted test device to form a final device.

2. The aforementioned reinforcement step further, The manufacturing method according to claim 1, comprising a reinforcing material placement step of obtaining the final device by placing reinforcing material on part or all of the outer surface of the test device.

3. The manufacturing method according to claim 2, wherein the thickness of the reinforcing material is greater than the thickness of the test device.

4. The aforementioned test device is a test socket, which is a prosthetic socket for test fitting. The adjustment step further includes: The manufacturing method according to claim 1, comprising an alignment adjustment step of performing the test fitting using the test socket and adjusting the alignment between the test socket and the test prosthetic component.

5. The aforementioned reinforcement step further, A composite construction step involves connecting a connecting member, which is interposed between the final prosthetic component to be used and the test socket and connects them to match the result of the alignment adjustment, to the test socket to form a composite body, The manufacturing method according to claim 4, comprising: an assembly reinforcement step of obtaining the final device by fixing a reinforcing material to at least a part or the whole of the outer surface of the assembly.

6. The manufacturing method according to claim 5, wherein the fixing of the reinforcing material is performed by a lamination technique.

7. The manufacturing method according to claim 6, wherein the laminated material used in the lamination technique is an expandable material.

8. The manufacturing method according to claim 7, wherein the stretchable material is stockinette.

9. The manufacturing method according to claim 7, wherein the laminated material is made of nylon, glass fiber, or carbon fiber.

10. The aforementioned reinforcement step further, The process includes an attachment step of attaching reinforcing tape to a part of the aforementioned composite body. The manufacturing method according to claim 5, wherein the reinforcing material is fixed by overlapping it with the reinforcing tape.

11. The manufacturing method according to claim 10, wherein the reinforcing tape is a carbon tape.

12. The manufacturing method according to claim 10, wherein the reinforcing tape is attached to the outer circumference near the opening at the proximal end of the test socket.

13. The manufacturing method according to claim 10, wherein the reinforcing tape is attached to the joint between the test socket and the connecting member.

14. The manufacturing method according to claim 10, wherein the reinforcing tape is attached to the distal end face of the connecting member.

15. The manufacturing method according to claim 10, wherein a groove corresponding to the thickness of the reinforcing tape is provided on the distal end face of the connecting member.

16. The manufacturing method according to claim 5, wherein the connecting member is three-dimensionally modeled based on the results of the alignment adjustment and manufactured by a three-dimensional printer.

17. The manufacturing method according to claim 5, wherein the connecting member is one of a plurality of connecting members of different shapes that have been prepared in advance.

18. The manufacturing method according to claim 5, wherein the coupling member has a recess on its proximal end face that conforms to the shape of the distal end of the test socket.

19. The manufacturing method according to claim 5, wherein the test socket and the connecting member are joined together with an adhesive.

20. The aforementioned final prosthetic limb component is an adapter equipped with a first hole, The distal end face of the final device is provided with a second hole that penetrates the connecting member and the reinforcing member. The second hole is secured by inserting a dummy bolt into the second hole of the connecting member when performing the lamination technique. The manufacturing method according to claim 6, wherein the adapter and the final device are fixed together by inserting bolts through the first hole and the second hole.

21. The manufacturing method according to claim 6, wherein the three-dimensional printer is a stacked three-dimensional printing device.

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