Shell structure prosthesis and method for producing same

Abstract

Provided is a shell structure prosthesis comprising: an outer shell pipe having a shell structure; and a prosthetic limb socket that is fixed to the inside of the proximal end of the outer shell pipe, is outputted by a three-dimensional printing device on the basis of a three-dimensional socket model conforming to a stump of a prosthetic limb user, and accommodates the stump.

Description

Shell structure prosthesis and its manufacturing method

[0001] The present invention relates to a prosthesis, in particular to a shell-structured prosthesis and a method for manufacturing the same.

[0002] Shell-structured prostheses are a type of prosthesis. In contrast to skeletal-structured prostheses, shell-structured prostheses are structures in which the shell structure supports the forces acting on the prosthesis and also defines its appearance. Shell-structured prostheses have the advantages of being relatively natural-looking and lightweight.

[0003] In recent years, efforts have been made to three-dimensionally scan the stumps of prosthetic limb users, digitize the stumps, and use them to manufacture prosthetic limbs (for example, Patent Document 1).

[0004] Utility Model Registration No. 3089376

[0005] However, with shell-structured prostheses, it is generally difficult to fine-tune the fitting and alignment of the residual limb. As a result, the compatibility of the residual limb with the prosthesis and the alignment of the prosthesis are not optimized. If a shell-structured prosthesis is used in this condition, there is a risk of problems such as damage to the user's residual limb.

[0006] The present invention has been made in consideration of the above-mentioned technical background, and its purpose is to provide a shell-structured prosthesis with improved adaptability to the stump.

[0007] The above-mentioned technical problems can be solved by a shell-structured prosthesis and a manufacturing method thereof having the following configuration.

[0008] That is, the shell-structured prosthesis of the present invention comprises a shell-structured outer pipe, and a prosthetic socket that is fixed inside the proximal end of the outer pipe, is output by a three-dimensional printing device based on a three-dimensional socket model that fits the stump of a prosthetic limb user, and accommodates the stump.

[0009] With this configuration, a shell-structured prosthesis can be provided using a prosthetic socket that is compatible with the stump output by the 3D printing device. Therefore, a shell-structured prosthesis with improved compatibility with the stump can be provided. Note that 3D printing devices generally allow prosthetic sockets to be manufactured inexpensively. Therefore, a shell-structured prosthesis with improved compatibility with the stump can be provided inexpensively.

[0010] The prosthetic socket may have a thickened portion on a portion of the edge at its proximal end.

[0011] This configuration improves the strength of the prosthesis socket and also increases the friction between the prosthesis socket and the outer pipe, thereby improving the connection between the prosthesis socket and the outer pipe.

[0012] The outer surface of the prosthetic socket may be provided with ribs.

[0013] This configuration improves the strength of the prosthesis socket and also increases the friction between the prosthesis socket and the outer pipe, thereby improving the connection between the prosthesis socket and the outer pipe.

[0014] The three-dimensional socket model may be provided with a through hole for inserting a fastener for connection to the outer pipe.

[0015] With this configuration, there is no need to drill holes after three-dimensional printing, which can prevent cracks in the prosthetic socket.

[0016] A counterbore may be provided on the inner peripheral surface of the through hole of the three-dimensional socket model.

[0017] With this configuration, the head (washer portion) of the fastener does not protrude toward the inner surface of the prosthetic socket, thereby protecting the stump.

[0018] A reinforced region with increased thickness may be provided around the through hole of the three-dimensional socket model.

[0019] With this configuration, the strength of the prosthetic socket around the through hole can be improved.

[0020] The present invention, viewed from another angle, is a method for manufacturing a shell-structured prosthesis, which includes a three-dimensional prosthetic socket model generation step for generating a three-dimensional prosthetic socket model that fits the user's stump, a prosthetic socket output step for outputting the three-dimensional prosthetic socket model as a prosthetic socket using a three-dimensional printing device, and a temporary prosthetic socket assembly step for assembling temporary prosthetic components to the prosthetic socket to obtain a temporary prosthesis in which the prosthetic socket is connected in series to the distal end component. A fitting step for fitting the temporary prosthesis to the stump and adjusting it to obtain a temporary prosthesis after fitting, a plaster placement step for placing plaster between the prosthetic socket and the distal end component in the temporary prosthesis after fitting, and a resin coating step for coating the prosthetic socket and the solidified plaster with a thermoplastic resin to obtain an outer shell pipe, and a shell-structured prosthesis assembly step for assembling the prosthetic socket and the outer shell pipe with prosthetic component parts to obtain a shell-structured prosthesis.

[0021] With this configuration, a shell-structured prosthesis can be provided using a prosthetic socket that is compatible with the stump output by the 3D printing device. Furthermore, the alignment of the prosthesis can also be adjusted through test fitting. Therefore, a shell-structured prosthesis with improved compatibility and alignment with the stump can be provided. Furthermore, 3D printing devices generally allow for inexpensive production of prosthetic sockets. Therefore, a shell-structured prosthesis with improved compatibility and alignment with the stump can be provided inexpensively.

[0022] The placing of plaster between the prosthetic socket and the distal end component in the plaster placing step may be performed by attaching the fitted temporary prosthesis to an alignment jig, removing the temporary prosthetic components between the prosthetic socket and the distal end component, and placing plaster between the prosthetic socket and the distal end component.

[0023] With this configuration, the positional relationship between the prosthetic socket and the distal end component can be easily preserved using an alignment jig.

[0024] In the plaster placement step, the plaster may be provided by injecting it into a cylinder designed based on the temporary prosthesis after fitting.

[0025] This configuration allows for easy placement of the plaster.

[0026] From another perspective, the present invention is a method for manufacturing a shell-structured prosthesis, which includes a three-dimensional prosthetic socket model generation step of generating a three-dimensional prosthetic socket model that fits the user's stump, a prosthetic socket output step of outputting the three-dimensional prosthetic socket model as a prosthetic socket using a three-dimensional printing device, a plaster placement step of arranging the prosthetic socket and a distal end component in a predetermined positional relationship and placing plaster between the prosthetic socket and the distal end component, a resin coating step of coating the prosthetic socket and the solidified plaster with a thermoplastic resin to obtain an outer shell pipe, and a shell-structured prosthesis assembly step of assembling the prosthetic socket and the outer shell pipe with prosthetic component parts to obtain a shell-structured prosthesis.

[0027] With this configuration, a shell-structured prosthesis can be provided using a prosthetic socket that is compatible with the stump output by the 3D printing device. Furthermore, since the prosthetic limb is manufactured with a predetermined alignment, the prosthetic limb can be provided in a short time. Therefore, a shell-structured prosthesis with improved compatibility and alignment with the stump can be provided in a short time. Furthermore, 3D printing devices generally allow prosthetic sockets to be manufactured inexpensively. Therefore, a shell-structured prosthesis with improved compatibility and alignment with the stump can be provided in a short time and at low cost.

[0028] The placing of plaster between the prosthetic socket and the distal end component in the plaster placing step may be performed by attaching the prosthetic socket and the distal end component to an alignment jig in the positional relationship, and placing plaster between the prosthetic socket and the distal end component.

[0029] With this configuration, the positional relationship between the prosthetic socket and the distal end component can be easily preserved using an alignment jig.

[0030] In the plaster placement step, the plaster may be provided by pouring it into a cylindrical body designed based on the predetermined positional relationship.

[0031] This configuration allows for easy placement of the plaster.

[0032] According to the present invention, it is possible to provide a shell-structured prosthesis with improved adaptability to the stump.

[0033] FIG. 1 is an overall configuration diagram of a prosthetic leg manufacturing system. FIG. 2 is a detailed configuration diagram of an information processing device. FIG. 3 is a flowchart (part 1) showing a method for manufacturing a shell-structured prosthetic leg. FIG. 4 is a flowchart (part 2) showing a method for manufacturing a shell-structured prosthetic leg. FIG. 5 is a schematic configuration diagram showing an example of the shape of a generated prosthetic leg socket. FIG. 6 is an enlarged view of the area around the reinforcing portion. FIG. 7 is an explanatory diagram showing a modified surface of a prosthetic leg socket. FIG. 8 is an explanatory diagram showing the state of the temporary prosthetic leg and the jig after plaster is injected. FIG. 9 is an explanatory diagram showing the procedure for extending the prosthetic leg socket using plaster. FIG. 10 is an external view of the shell-structured prosthetic leg after assembly. FIG. 11 is an explanatory diagram showing how the prosthetic leg socket and the outer pipe are joined with bolts. FIG. 12 is a cross-sectional view of an example of a 3D-printed cylinder.

[0034] DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Preferred embodiments of the present invention will now be described in detail with reference to the accompanying drawings.

[0035] (1. First Embodiment) As a first embodiment, an example in which the present invention is applied to a shell-structured prosthetic leg, its manufacturing system, and its manufacturing method will be described. Note that in this embodiment, a below-knee prosthetic leg will be described as an example, but the present invention can be applied to prosthetic limbs in general. Therefore, it may also be applied to other types of prosthetic legs or prosthetic arms.

[0036] (1.1 Configuration of the prosthetic leg manufacturing system) Fig. 1 is a diagram showing the overall configuration of a 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. Connected to the information processing device 10 are a 3D scanner 20, a 3D printer 30, an input device 40, and a display device 50. The prosthetic leg manufacturing system 100 also includes a jig 60 for storing alignment, which will be described later.

[0037] 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 measurements 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 or the like. 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 visually, such as a display. The jig 60 is a device for adjusting or saving alignment by fixing each component part of the prosthetic limb in a predetermined manner, as will be described later.

[0038] FIG. 2 is a detailed configuration diagram of the information processing device 10. As is clear from the diagram, the information processing device 10 includes a control unit 11, a memory unit 12, a communication unit 13, a display control unit 15, and an I / O processing unit 16. The control unit 11 is a calculation device such as a CPU, and executes programs to realize various operations described below. The memory unit 12 is a storage device such as ROM / RAM, flash memory, or a hard disk, and stores programs and data to realize various operations described below. 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, etc., displayed on the display device 50. The I / O processing unit 16 processes input and output signals to and from external devices.

[0039] The hardware configuration and network configuration are not limited to those according to this embodiment, and therefore other configurations may be adopted, such as providing a separate server for storing and providing data.

[0040] (1.2 Manufacturing Method of Shell-Structured Prosthetic Leg) Next, a method of manufacturing a shell-structured prosthetic leg using the prosthetic leg manufacturing system 100 will be described below in order.

[0041] FIG. 3 is a flowchart (part 1) showing a method for manufacturing a shell-structured prosthetic leg, and FIG. 4 is a flowchart showing a continuation of the flowchart shown in FIG. 3, i.e., a flowchart (part 2) showing a method for manufacturing a shell-structured prosthetic leg.

[0042] 3, first, a worker manufacturing a shell-structured prosthetic limb performs a three-dimensional scan of the stump of the prosthetic limb user using a three-dimensional scanner 20. The information processing device 10 performs a process of importing the scan data generated by the three-dimensional scan into the information processing device 10 (S10).

[0043] When the import process into the information processing device 10 is completed, the information processing device 10 generates a three-dimensional model of the stump, and then performs a process of generating a three-dimensional shape of the prosthetic socket based on the three-dimensional model (S20).

[0044] Here, because the prosthetic socket is fixed to and reinforced by the outer shell pipe as described below, it can be thinner than when used in a skeleton-structured prosthesis. This allows for a lighter prosthetic socket. The time required to provide a shell-structured prosthesis, from mold making to delivery, is as short as a few hours. Therefore, making the prosthetic socket produced by 3D printing such a thin structure also contributes to maintaining the same prosthetic provision time as before. Even in this case, strength can be maintained by taking various reinforcing measures, as described below.

[0045] The process of generating a three-dimensional shape of a prosthetic socket based on a three-dimensional model of the stump can be realized by various methods. For example, a trained model obtained by machine learning may be used to predict and output a three-dimensional shape of a prosthetic socket that fits the stump. Alternatively, the three-dimensional shape of the prosthetic socket may be generated based on the stump model according to predetermined rules.

[0046] In this embodiment, the information processing device 10 automatically generates a three-dimensional socket shape based on a three-dimensional model of the stump. However, the present invention is not limited to this example. For example, a worker may design the three-dimensional shape of the prosthetic socket using CAD or the like based on the three-dimensional model of the stump. Also, only a portion of the shape may be automatically generated based on a learned model or predetermined rules.

[0047] 5 is a schematic diagram showing an example of the generated prosthetic socket shape. Fig. 5(a) is a side view of the prosthetic socket, and Fig. 5(b) is a front view of the prosthetic socket. As is clear from Fig. 5, the prosthetic socket 70 has a protruding portion 72 with a square cross section at its distal end (or tip). A thicker reinforcing portion 71 is provided at the proximal end (or edge) on the back side of the prosthetic socket 70. A recess 73 corresponding to the patellar tendon is provided on the front side of the prosthetic socket 70.

[0048] 6 is an enlarged view of the periphery of the reinforcing portion 71. As is clear from the drawing, the reinforcing portion 71 protrudes slightly outward in the radial direction and is given a thickness.

[0049] This configuration improves the strength of the prosthetic socket and also increases the friction between the prosthetic socket and the heat-shrinking outer pipe, thereby improving the bond between the prosthetic socket and the outer pipe.

[0050] Although the present embodiment has been described as having a smooth surface, the present invention is not limited to this configuration. For example, the outer surface of the prosthetic socket may be provided with a plurality of ribs (protrusions).

[0051] 7A and 7B are explanatory diagrams showing modified examples of the surface of a prosthetic socket. Fig. 7A shows a configuration in which a plurality of ribs extending in the vertical direction are formed on the prosthetic socket surface 70', and Fig. 7B shows a configuration in which ribs are formed in a geometric (lattice-like) pattern on the prosthetic socket surface 70''.

[0052] This configuration improves the strength of the prosthetic socket and also increases the friction between the prosthetic socket and the heat-shrinking outer pipe, thereby improving the connection between the prosthetic socket and the outer pipe.

[0053] Returning to FIG. 3, once the generation of the three-dimensional shape (or three-dimensional model) of the prosthetic socket is completed, the information processing device 10 performs a process of outputting the same shape in three dimensions using the three-dimensional printer 30 (S12).

[0054] After this 3D printing process, the worker creates a temporary prosthetic leg by assembling the 3D output prosthetic leg socket with other prosthetic leg components (S13). Here, the other prosthetic leg components are parts required to create a temporary prosthetic leg used for alignment adjustment, and in this embodiment, they are a cup coupling adapter attached to the prosthetic leg socket, a metal pipe attached to the coupling adapter, and a foot (distal end part) attached to the other end of the metal pipe. Note that the coupling adapter is configured so that the angle between the prosthetic leg socket and the metal pipe can be adjusted.

[0055] After assembling the temporary prosthetic limb, the worker has the prosthetic limb user wear the temporary prosthetic limb and adjusts the position and / or angle of the prosthetic limb socket (test fitting) (S15). This allows the alignment of the prosthetic limb to be adjusted.

[0056] As described above, the prosthetic socket 70 is provided with the convex portion 72 having a rectangular cross section, so that the positional relationship and alignment between the prosthetic socket, whose three-dimensional model is outputted on the information processing device 10, and the other prosthetic component parts can always be constant. Therefore, for example, after the test fitting, it is possible to modify the three-dimensional shape of the prosthetic socket 70 on the information processing device 10 while maintaining the positional relationship and alignment with the other prosthetic component parts. The cross-sectional shape of the convex portion 72 may be any shape as long as it provides connection with the other prosthetic component parts in a constant positional relationship and alignment, and therefore may be a shape other than a rectangle.

[0057] After the test fitting, the worker attaches the temporary prosthetic leg for which test fitting has been completed to an alignment jig 60 (S16), and saves the positions and angles of the components that make up the prosthetic leg. Specifically, the prosthetic leg socket and foot of the temporary prosthetic leg are fixed to the jig 60 while maintaining their respective positions and angles.

[0058] Thereafter, the worker injects plaster into the prosthetic socket and fixes the prosthetic socket to the jig (S17).

[0059] 8 is an explanatory diagram showing the state of the temporary prosthetic leg and jig 60 after the plaster has been poured in. As is clear from the figure, the jig 60 has two beams extending horizontally from the support, namely, a first beam 61 extending horizontally near the floor surface, and a second beam 62 extending horizontally vertically above the temporary prosthetic leg on the opposite side.

[0060] A fixing portion (clamp) is provided on the first beam 61, on which the foot portion 83 of the temporary prosthetic limb is placed and fixed. In addition, a socket support pipe 63 extends vertically downward from the tip of the second beam 62 toward the center of the prosthetic limb socket 80. In the same figure, plaster 84 has been poured into the inside of the prosthetic limb socket 80 and has hardened. Therefore, the socket support pipe 63 and the prosthetic limb socket 80 are fixed via the plaster 84. In addition, a coupling adapter 81 (not shown) and a metal pipe 82 are attached between the prosthetic limb socket 80 and the foot portion 83.

[0061] Returning to Figure 3, once the fixation of the prosthetic socket has been completed, the worker removes the coupling adapter 81 and the metal pipe 82 from the temporary prosthetic limb fixed to the jig 60 (S18). Specifically, the clamp on the first beam 61 is loosened, the foot 83 is removed, the coupling adapter 81 and the metal pipe 82 are removed, and the foot 83 is then fixed again to the first beam. As a result, the prosthetic limb socket 80 and the foot 83 are fixed to the jig 60 in a state where they are spaced apart while maintaining their relative positional relationship (i.e., the portion surrounded by the dashed line in Figure 8 is removed).

[0062] Referring now to FIG. 4, after removing the coupling adapter 81 and the metal pipe 82, the worker extends the prosthetic socket 80 with plaster (S19).

[0063] 9A and 9B are explanatory diagrams relating to the procedure for extending the prosthetic socket 80 using plaster. Fig. 9A is an explanatory diagram relating to the preparation for using plaster, and Fig. 9B is an explanatory diagram relating to the hardened plaster.

[0064] As shown in FIG. 1A, first, the worker rolls the sheet-like material 85 into a cylindrical shape to cover the area between the prosthetic socket 80 and the foot 83. Various materials can be used for the sheet-like material 85, including soft foam sheets such as polyethylene, X-ray sheets, and soft polypropylene. Then, while maintaining the cylindrical space between the prosthetic socket 80 and the foot 83, the jig 60 is turned upside down and the foot 83 is removed. In this state, the worker pours plaster into the cylindrical space and allows it to solidify. After solidification, the sheet-like material 85 is removed. FIG. 1B shows the prosthetic socket 80 with the sheet-like material removed and the plaster portion 86 extending therefrom.

[0065] Returning to FIG. 4 , after extending the prosthetic socket 80 with plaster, the worker covers the prosthetic socket 80 and the plaster portion 86 with heated and softened polyvinyl chloride (PVC) to form an outer pipe (or shank portion) with a shell structure (S21). More specifically, the worker first covers the prosthetic socket 80 and the plaster portion 86 with heated and softened PVC. Then, once the PVC has hardened to a certain extent, the plaster portion 86 inside the PVC is removed. After removing the plaster portion 86, the PVC is struck with a hammer or the like to adjust it to fit the shape of the prosthetic socket 80. This allows the PVC to conform to the shape of the prosthetic socket, including the depression 73 corresponding to the patellar tendon.

[0066] In this embodiment, the outer pipe is formed from polyvinyl chloride (PVC), but other materials may be used as long as they soften and then harden again when heated, such as polylactic acid (PLA) or carbon PLA, acrylonitrile butadiene styrene (ABS), thermoplastic polyester (PETG), or polycarbonate (PC).

[0067] After forming the outer pipe, the worker removes the plaster from inside the prosthetic socket 80 (S22) and removes the prosthetic leg from the jig 60.

[0068] After removing the plaster, the worker assembles the prosthetic socket 80, the outer shell pipe, and the foot to form a shell-structured prosthetic leg (S23). At this time, in order to join the dissimilar materials of the resin prosthetic socket formed by 3D printing and the PVC outer shell pipe, adhesive is applied to part or all of the outer periphery of the prosthetic socket to join the prosthetic socket 80 and the outer shell pipe.

[0069] 10 is an external view of the assembled shell-structure prosthesis. As is clear from the figure, the prosthetic socket 80 is attached to the proximal end of the outer shell pipe 87 made of PVC. The entire prosthetic socket 80 may be contained within the outer shell pipe 87, or only a portion of it may be contained within the outer shell pipe 87. The foot 83 is attached to the distal end of the outer shell pipe 87. In this case, a recess 871 (or PTB bar) is provided in the portion of the outer shell pipe 87 corresponding to the knee, which is formed along the recess 73 corresponding to the patellar tendon.

[0070] In this embodiment, the configuration in which the prosthetic socket 80 and the outer pipe 87 are joined together with adhesive has been described, but instead of or in addition to adhesive, the two may be joined together with fasteners such as bolts or rivets, i.e., mechanical means.

[0071] 11 is an explanatory diagram showing how the prosthetic socket 80 and the outer pipe 87 are connected with bolts. As is clear from the figure, through holes for inserting bolts 801 are provided on the inside and outside of the prosthetic socket 80. At this time, as is clear from the figure, a counterbore is provided on the inner peripheral surface of the through hole.

[0072] With this configuration, the head (washer portion) of the fastener does not protrude from the inner surface of the prosthetic socket 80, thereby protecting the stump.

[0073] Additionally, a reinforcement shape region 802 with increased thickness is provided around the through hole.

[0074] With this configuration, the strength of the prosthetic socket 80 around the through-hole can be improved.

[0075] It is desirable that this through-hole be provided in advance in the three-dimensional shape (or three-dimensional model) of the prosthetic socket.

[0076] With this configuration, there is no need to drill holes after three-dimensional printing, which can prevent cracks in the prosthetic socket.

[0077] Returning to Fig. 4, after the assembling work, the worker trims the edge of the prosthetic socket (S25), thereby making the edge of the prosthetic socket neat.

[0078] Finally, the worker performs a final fitting of the finished shell-structured prosthetic leg after trimming on the prosthetic leg user (S26), thereby completing the manufacturing process of the shell-structured prosthetic leg.

[0079] According to the configuration of this embodiment, a shell-structured prosthetic leg can be provided using a prosthetic leg socket that is compatible with the stump output by the 3D printer 30. In addition, the alignment of the prosthetic leg can also be adjusted through test fitting. Therefore, a shell-structured prosthetic leg with improved compatibility and alignment with the stump can be provided. In addition, the 3D printer 30 generally allows prosthetic leg sockets to be manufactured inexpensively. Therefore, a shell-structured prosthetic leg with improved compatibility and alignment with the stump can be provided inexpensively.

[0080] (2. Second Embodiment) In the first embodiment, a temporary prosthetic limb is created and test fitting is performed, but in this embodiment, a prosthetic limb is created based on a predetermined alignment.

[0081] (2.1 Configuration of the Prosthetic Leg Manufacturing System) The configuration of the prosthetic leg manufacturing system 100 is substantially the same as that of the first embodiment, and therefore a description thereof will be omitted here.

[0082] (2.2 Manufacturing Method of Shell-Structured Prosthetic Leg) The process of 3D scanning the stump and 3D printing the prosthetic socket (S10 to S12) is the same as in the first embodiment, so a description thereof will be omitted here. After these processes, the worker attaches the 3D printed prosthetic socket and foot to the jig 60 with a preset alignment (S16). The subsequent processing (S17 to S26) is substantially the same except that the process of removing the adapter and pipe (S18) is omitted because there is no temporary prosthetic leg, so a description thereof will be omitted.

[0083] With this configuration, a shell-structured prosthetic leg can be provided using a prosthetic leg socket that is compatible with the stump output by the 3D printer 30. Furthermore, since the prosthetic leg is manufactured with a predetermined alignment without test fitting, the prosthetic leg can be provided in a short time. Therefore, a shell-structured prosthetic leg with improved compatibility and alignment with the stump can be provided in a short time. In addition, 3D printing devices generally allow prosthetic leg sockets to be manufactured inexpensively. Therefore, a shell-structured prosthetic leg with improved compatibility and alignment with the stump can be provided in a short time and at low cost.

[0084] (3. Modifications) The present invention can be implemented in various modifications.

[0085] In the first embodiment, a configuration in which a sheet-like material 85 is wrapped around the prosthetic socket and extended with plaster is described. However, the present invention is not limited to such a configuration. For example, physical quantities related to the temporary prosthesis may be measured after a test fitting, and a cylindrical body for extending the prosthetic socket may be created based on the measurement data. The cylindrical body may then be filled with plaster to extend the prosthetic socket. Here, physical quantities include, for example, the socket horizontal, forehead, and sagittal plane angles, the foot horizontal, forehead, and sagittal plane angles, the positional relationship between the socket and the foot, and the prosthetic height. This cylindrical body can be manufactured using various methods. For example, it may be created by 3D printing, or by rolling up sheet-like materials such as X-ray film or flexible polyethylene.

[0086] Figure 12 is a cross-sectional view of an example of a 3D printed cylinder 90. The proximal end of the cylinder 90 shown at the top of the figure has a recess for receiving a socket. This recess is designed to fit the convex portion of the distal end of the prosthetic socket. Meanwhile, the distal end of the cylinder 90 is open, through which plaster can be injected.

[0087] With this configuration, the plaster can be placed easily and with high precision, regardless of the skill of the worker.

[0088] Although the embodiments of the present invention have been described above, the above embodiments merely illustrate some of the application examples of the present invention, and the technical scope of the present invention is not intended to be limited to the specific configurations of the above embodiments. Furthermore, the above embodiments can be combined as appropriate within the scope of not causing any contradiction.

[0089] The present invention can be used in the industry of manufacturing prosthetic limbs and the like.

[0090] 10 Information processing device 20 Three-dimensional scanner 30 Three-dimensional printer 40 Input device 50 Display device 60 Jig

Claims

1. A shell-structured prosthesis comprising: an outer shell pipe with a shell structure; and a prosthetic socket that is fixed inside the proximal end of the outer shell pipe, is output by a three-dimensional printing device based on a three-dimensional socket model that fits the residual limb of a prosthetic limb user, and accommodates the residual limb.

2. A shell structure prosthesis as described in claim 1, wherein a portion of the edge of the proximal end of the prosthesis socket is provided with an increased thickness.

3. A shell-structure prosthesis as described in claim 1, wherein the outer surface of the prosthesis socket is provided with ribs.

4. A shell structure prosthesis as described in claim 1, wherein the three-dimensional socket model has a through hole for inserting a fastener for connecting to the outer pipe.

5. A shell-structured prosthesis as described in claim 4, wherein a counterbore is provided on the inner peripheral surface of the three-dimensional socket model of the through-hole.

6. A shell structure prosthesis as described in claim 4, wherein a reinforced area of ​​increased thickness is provided around the through hole of the three-dimensional socket model.

7. A method for manufacturing a shell-structured prosthesis, comprising: a three-dimensional prosthetic socket model generation step of generating a three-dimensional prosthetic socket model that fits the user's stump; a prosthetic socket output step of outputting the three-dimensional prosthetic socket model as a prosthetic socket using a three-dimensional printing device; a temporary prosthesis assembling step of assembling temporary prosthetic components to the prosthetic socket to obtain a temporary prosthesis in which the prosthetic socket is connected in series with the distal end component; a fitting step of fitting the temporary prosthesis to the stump and adjusting it to obtain a fitted temporary prosthesis; a plaster placement step of placing plaster between the prosthetic socket and the distal end component in the fitted temporary prosthesis; a resin coating step of coating the prosthetic socket and the solidified plaster with thermoplastic resin to obtain an outer pipe; and a shell-structured prosthesis assembling step of assembling the prosthetic socket and the outer pipe with prosthetic component components to obtain a shell-structured prosthesis.

8. A method for manufacturing a shell-structured prosthesis as described in claim 7, wherein placing plaster between the prosthetic socket and the foot in the plaster placement step is performed by attaching the fitted temporary prosthesis to an alignment jig, removing the temporary prosthetic components between the prosthetic socket and the distal end part, and placing plaster between the prosthetic socket and the distal end part.

9. The method for manufacturing a shell structure prosthesis according to claim 7, wherein in the plaster placement step, the plaster is provided by injecting it into a cylinder designed based on the temporary prosthesis after fitting.

10. A method for manufacturing a shell-structured prosthesis, comprising: a three-dimensional prosthetic socket model generation step of generating a three-dimensional prosthetic socket model that fits the user's stump; a prosthetic socket output step of outputting the three-dimensional prosthetic socket model as a prosthetic socket using a three-dimensional printing device; a plaster placement step of arranging the prosthetic socket and a distal end component in a predetermined positional relationship and placing plaster between the prosthetic socket and the distal end component; a resin coating step of coating the prosthetic socket and the solidified plaster with thermoplastic resin to obtain an outer pipe; and a shell-structured prosthesis assembly step of assembling the prosthetic socket and the outer pipe with prosthetic component components to obtain a shell-structured prosthesis.

11. A method for manufacturing a shell-structured prosthesis as described in claim 10, wherein placing plaster between the prosthetic socket and the distal end component in the plaster placement step is performed by attaching the prosthetic socket and the distal end component to an alignment jig in the positional relationship and placing plaster between the prosthetic socket and the distal end component.

12. The method for manufacturing a shell structure prosthesis as described in claim 10, wherein in the plaster placement step, the plaster is provided by pouring it into a cylindrical body designed based on the predetermined positional relationship.

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