Device manufacturing method, manufacturing device, and manufacturing program
Patent Information
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- INSTALIMB INC
- Filing Date
- 2025-10-29
- Publication Date
- 2026-08-06
Smart Images
Figure JP2025037977_06082026_PF_FP_ABST
Abstract
Description
Method for manufacturing a device, manufacturing apparatus, and manufacturing program
[0001] The present invention relates to an apparatus or the like for generating the shape of a device including a prosthesis, an orthosis, or a part thereof, or a manufacturing method thereof.
[0002] In recent years, attempts have been made to manufacture a device to be worn on the body, including parts (for example, a prosthesis socket) of a prosthesis, an orthosis, or a part thereof, using a three-dimensional printer (3D printer) (as an example, Patent Document 1).
[0003] Japanese Patent No. 6948726
[0004] By the way, this type of device is manufactured by measuring, scanning, or taking a mold of the shape of a part of the body and designing the shape of the device to fit thereto.
[0005] However, during device wear, the shape of the body actually changes in various ways. Therefore, even if the device shape is designed based on the shape of a part of the body in a specific state, there may be portions where the device does not fit properly with the body, and as a result, the fitting quality of the device to the body may deteriorate.
[0006] For example, during device wear, the body can actually take various limb positions. When the limb position changes, due to factors such as the movement of subcutaneous tissue, the parts that bulge or sink on the surface of the body change, and the surface shape of the body changes. Even when the limb position does not change, if the user of the device applies force or relaxes on a part of the body, the surface of the body may bulge or sink, and the surface shape of the body may change. Also, even when wearing a pressure-type interface such as a liner, the surface shape of the body may change. Further, even when an external force acts due to an instrument such as a jig, the surface shape of the body may change. Due to these changes in the surface shape, as a result, the fitting quality of the device to the body may deteriorate.
[0007] The present invention has been made in view of the above-described technical background, and an object thereof is to improve the fitting quality of a device to be worn on the body.
[0008] The technical problems described above can be solved by a device manufacturing method, manufacturing apparatus, and manufacturing program having the following configuration.
[0009] In other words, the device manufacturing method according to the present invention comprises a scanning step of scanning a part of the body before and after a change using a three-dimensional scanner, and a device model generation step of generating a device model, which is a three-dimensional model of a device to be attached to the part of the body, based on a body model, which is a three-dimensional model relating to the scan data obtained by the scan.
[0010] With this configuration, the device shape can be generated based on 3D body shape data that combines the 3D shapes of parts of the body before and after a change. This allows for the design of a device that takes into account changes in body shape caused by various factors. As a result, the fitting quality of the device worn on the body can be improved.
[0011] The system may further include a device output step in which the device model is output using a 3D printer.
[0012] With this configuration, a device model can be materialized using a 3D printer. This enables the low-cost manufacturing of devices, among other things.
[0013] The scan data may be a single scan data obtained by scanning a part of the body in one state, pausing the scan, and then scanning another part of the body in a different state, or by repeating this process.
[0014] With this configuration, body parts of different shapes can be easily synthesized using scanning techniques.
[0015] The scan data may be a plurality of scan data, including scan data obtained by scanning the part of the body before the change and scan data obtained by scanning the part of the body after the change.
[0016] With this configuration, it is possible to obtain multiple different body shapes for a part of the body, allowing for flexible post-processing of those shapes.
[0017] The aforementioned change may be a change in the position of a part of the body.
[0018] With this configuration, the device shape can be generated based on 3D body shape data that combines the 3D shapes of parts of the body in multiple different limb positions. This allows for the design of a device that takes into account changes in body shape caused by changes in limb position. As a result, the fitting quality of the device worn on the body can be improved.
[0019] The aforementioned limb position may include a limb position in which there is insufficient space to perform a three-dimensional scan and in which there are parts of the body that are difficult to scan in three dimensions.
[0020] With this configuration, if there are areas where 3D scanning is difficult in a particular limb position, the limb position can be changed to one where 3D scanning is possible before performing the 3D scan on those difficult areas, while the remaining areas can be scanned in the specific limb position. This allows for obtaining the desired 3D scan model and improving the accuracy of the scan data.
[0021] The aforementioned change may also be due to the jig coming into contact with the part of the body.
[0022] This configuration allows for consideration of changes in the body surface shape caused by the jig, thereby improving the fitting quality of the device worn on the body.
[0023] The aforementioned change may involve attaching a compression garment to the part of the body.
[0024] This configuration allows for consideration of changes in body surface shape due to the wearing of a pressure garment, thereby improving the fitting quality of devices worn on the body.
[0025] The device model generation step may further include a synthetic body model generation step of generating a synthetic body model by combining parts of each of the body models relating to each of the scan data, wherein the device model is generated based on the synthetic body model.
[0026] This configuration allows for the design of devices that take into account changes in body shape caused by changes in limb position. This improves the fitting quality of devices worn on the body.
[0027] In the step of generating the synthetic body model, the generation of the synthetic body model may be performed after aligning each body model on a 3D CAD system.
[0028] With this configuration, a natural-looking synthetic body model can be created from body parts in different states through alignment.
[0029] The alignment may be performed based on the shape of each body model and the markings attached to a part of the body.
[0030] With this configuration, alignment can be easily performed using markers on the body surface as a guide.
[0031] The marking may be a marking directly applied to a part of the body or a marking applied to an interface attached to a part of the body.
[0032] With this configuration, the models can be aligned based on the markings.
[0033] The marking may be a marker directly attached to the part of the body or a marker attached to an interface mounted on the part of the body.
[0034] With this configuration, it is possible to align the models using markers as a guide.
[0035] The aforementioned markings may be affixed to the body part based on the location of bones, tendons, fat, or muscles.
[0036] According to such a configuration, alignment can be easily performed using information on the positions of various subcutaneous tissues as a clue.
[0037] The alignment may be performed based on deep information regarding a part of the body.
[0038] According to such a configuration, by utilizing deep information, alignment of three-dimensional models related to each scan data becomes easy.
[0039] The deep information may include information on the positions of bones, tendons, fats, or muscles.
[0040] According to such a configuration, information on the positions of various subcutaneous tissues can be referred to.
[0041] The device model generation step may further include a soft tissue information providing step of providing information on soft tissues specified based on the plurality of scan data.
[0042] According to such a configuration, a device model can be further generated based on information on soft tissues.
[0043] The change is a change in the limb position related to a part of the body, and the body model may be a model obtained by combining different parts when in different limb positions among parts of the body.
[0044] According to such a configuration, since a body model can be generated by combining different parts of a part of the body in different limb positions, a device model considering a plurality of limb positions can be designed.
[0045] The part of the body includes joints, the change is a change in the limb position related to the part of the body, the limb position includes the limb position with the joint at a first angle and the limb position with the joint at a second angle different from the first angle, and the shape of the device model is at least based on the body model related to the limb position with the joint at the first angle and the body model related to the limb position with the joint at the second angle. It may be such a thing.
[0046] According to such a configuration, by using two or more body models in different limb positions, it is possible to design a device that also takes into account the change in body shape caused by the change in joint angle. Thereby, the fitting quality of the device can be improved.
[0047] The device may be a prosthetic limb, an orthosis or a part thereof.
[0048] According to such a configuration, the fitting quality of various body-worn devices can be improved.
[0049] Viewed from another angle, the present invention is a device manufacturing apparatus, which includes a scan data acquisition unit that acquires scan data obtained by scanning a part of the body before and after the change using a three-dimensional scanner, and based on a body model that is a three-dimensional model related to the scan data, a device model generation unit that generates a device model that is a three-dimensional model of a device worn on the part of the body.
[0050] Viewed from another angle, the present invention is a device manufacturing method, which includes a scan data acquisition step of acquiring scan data obtained by scanning a part of the body before and after the change using a three-dimensional scanner, and a device model generation step of generating a device model that is a three-dimensional model of a device worn on the part of the body based on a body model that is a three-dimensional model related to the scan data.
[0051] Viewed from a different perspective, the present invention is a device manufacturing program comprising: a scan data acquisition step of acquiring scan data obtained by scanning a part of the body before and after a change using a three-dimensional scanner; and a device model generation step of generating a device model, which is a three-dimensional model of a device to be attached to the part of the body, based on a body model, which is a three-dimensional model relating to the scan data.
[0052] According to the present invention, the fitting quality of devices worn on the body can be improved.
[0053] Figure 1 is an overall diagram of the prosthetic arm manufacturing system. Figure 2 is a detailed diagram of the information processing device. Figure 3 is a flowchart of the method for manufacturing a prosthetic arm (first embodiment). Figure 4 is an explanatory diagram showing an example of marking applied to the body surface from the shoulder area of the trunk (or chest) to the stump of the upper arm. Figure 5 is a front view of the body with the arm abducted. Figure 6 is a front view of the body with the armpit closed. Figure 7 is an explanatory diagram of the surface related to the upper arm. Figure 8 is an explanatory diagram of a three-dimensional model related to the upper arm prosthetic socket. Figure 9 is a flowchart of the method for manufacturing a prosthetic arm (second embodiment). Figure 10 is a flowchart of the method for manufacturing a lower leg prosthesis. Figure 11 is an explanatory diagram showing an example of marking applied to the body surface from the thigh to the stump of the lower leg. Figure 12 is a side view of the leg with the knee slightly flexed. Figure 13 is a side view of the leg with the knee greatly flexed. Figure 14 is an explanatory diagram showing the three-dimensional model synthesis process. Figure 15 is an explanatory diagram showing an example of a surface created in the above process. Figure 16 is an explanatory diagram of a three-dimensional model relating to a lower leg prosthesis socket. Figure 17 is an explanatory diagram explaining the function of the lower leg prosthesis socket.
[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 manufacturing system and manufacturing method for an upper arm prosthesis or a part thereof, as an example of a body-worn device, will be described. In this embodiment, an upper arm prosthesis is described as an example, but it can also be applied to other prosthetic limbs. Therefore, it may be applied to prosthetic arms used in other parts of the body, for example, forearm prostheses, or to prosthetic limbs applied to other limbs such as prosthetic legs and fingers. Furthermore, the present invention may be applied to a manufacturing system and manufacturing method for a body-worn orthotic device or a part thereof.
[0056] (1.1 Configuration of the Upper Arm Prosthesis Manufacturing System) Figure 1 is an overall configuration diagram of the prosthetic arm manufacturing system 100 (or device manufacturing system 100) according to this embodiment. As is clear from the figure, the prosthetic arm 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. In this embodiment, a handheld scanner capable of acquiring images using a laser scanning method is used, but the scanning method is not particularly limited. For example, as in this embodiment, the object may be fixed and the 3D scanner 20 may be moved, or the 3D scanner 20 may be fixed and the object may be moved. Furthermore, the 3D measurement means is not particularly limited and includes all methods such as laser scanners, stereo cameras, pattern projection, and optical methods using ToF cameras. Moreover, the 3D scanner 20 does not need to be a dedicated device; for example, it may be an information processing device equipped with a camera, distance sensor, etc., such as a smartphone or tablet terminal. 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 such as ROM / RAM, flash memory, or hard disk (including non-temporary computer-readable storage media), 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] As will be described later, the processor 11, together with the memory unit 12 and the like, provides various functions. Specifically, it functions as a scan data acquisition unit, a 3D model generation unit, a device model generation unit, a data conversion unit, a 3D print command generation unit, and so on. The scan data acquisition unit processes the acquisition of 3D scan data (point cloud data, etc.) and image data acquired by the 3D scanner 20 and imported into the information processing device 10, and sends them to the processor 11. The 3D model generation unit processes the generation of a corresponding 3D model from the 3D scan data. The device model generation unit processes the generation of a 3D model of a device attached to a body based on a 3D model relating to that body. The data conversion unit processes the conversion of the 3D model data of the device into a data format that can be output by the 3D printer 30. The 3D print command generation unit processes the generation and transmission of a command for outputting the converted 3D model data from the 3D printer 30.
[0060] The device model generation unit further includes a 3D CAD function provision unit, a composite model generation unit, a surface conversion unit, a thickness application unit, and the like. The 3D CAD function provision unit displays the 3D model related to the 3D scan data on the information processing device 10 or a display device connected thereto, and processes to receive and reflect user operations on the 3D model, such as operations for alignment and operations for editing the shape. The surface conversion unit processes to convert the 3D model related to the body into surface model data related to its outer surface. The thickness application unit processes to apply thickness to the surface model to generate a 3D model of the device.
[0061] 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.
[0062] Furthermore, in this embodiment, the computer program may be provided as a computer program product or as a recording medium for recording the computer program.
[0063] (1.2 Method for Manufacturing an Upper Arm Prosthesis) Next, a method for manufacturing a prosthetic arm, particularly an upper arm prosthesis, using the prosthetic arm manufacturing system 100 will be described below in order.
[0064] Figure 3 is a flowchart illustrating a method for manufacturing a prosthetic arm. As is clear from the figure, in this embodiment, the prosthetic arm maker first makes predetermined markings on the body, including the vicinity of the stump of the upper arm (S11). In this embodiment, the markings are made based on information regarding the location and extent of subcutaneous tissue (including bone, tendons, fat, or muscle, etc.). The markings also function as information for obtaining alignment, and in this embodiment, they are drawn directly on the body surface using a pen or the like.
[0065] Figure 4 is an explanatory diagram showing an example of marking applied to the body surface from the shoulder area of the trunk 62 (or chest) to the stump 63 of the upper arm 61. Figure (a) is a front view of the body, and Figure (b) is a side view of the body.
[0066] As is clear from Figure (a), the frontal center of the upper arm 61 shows a pair of clavicular lines 606 extending along the clavicle above and below the clavicle, a pressing area 605 indicating the pressing point of the prosthetic socket, and a trimming line 609 indicating the proximal edge of the prosthetic socket. Also, the frontal center of the upper arm 61 shows an anterior reference line 601 extending in the longitudinal direction of the upper arm 61. Multiple orthogonal line segments are drawn on the anterior reference line 601 toward the stump 63. On the side closest to the trunk 62, an axillary level line 602 is drawn, and from there, six equally spaced lines 603 are drawn toward the stump 63 at equal intervals.
[0067] As is clear from Figure (b), the lateral reference line 604 extends in the longitudinal direction of the upper arm 61, centered on the outer surface of the upper arm 61. Near the shoulder, the scapular line 607 is drawn along the outer edge of the scapula, and the acromion line 608 is drawn along the outer edge of the acromion portion of the scapula.
[0068] Returning to Figure 3, once the marking is complete, the prosthetic arm maker first uses the 3D scanner 20 to scan the inner side (or trunk side) and the outer side of the posterior aspect of the upper arm 61, which is in an abducted position (i.e., with the armpit open), to acquire point cloud data (S12). At this time, the angle at which the armpit is opened is set to approximately 20° to 30°, taking into consideration the minimization of deformation near the shoulder and the limits of what the 3D scanner 20 can scan on the inner side of the upper arm 61.
[0069] At the same time, the 3D scanner 20 acquires an image of the body surface along with the 3D point cloud data. As will be described later, this makes it possible to obtain an image of the marked body surface.
[0070] Figure 5 is a front view of the body with the upper arm 61 abducted. As is clear from the figure, opening the armpit creates space on the inside of the upper arm 61 (or on the trunk 62 side), allowing the upper arm 61 to be scanned from the inside.
[0071] Returning to Figure 3, once the scan with the upper arm 61 abducted is complete, the prosthetic arm maker then uses the 3D scanner 20 to scan the outer side of the upper arm 61 and the shoulder area with the armpit closed to acquire point cloud data (S13). At this time, the 3D scanner 20 also acquires images of the body surface along with the 3D point cloud data. As will be described later, this makes it possible to acquire images of the marked body surface.
[0072] Figure 6 is a front view of the body with the arms not abducted and the armpits closed. As is clear from the figure, there is almost no gap between the trunk 62 and the upper arm 61, making it difficult to scan the inside of the upper arm 61, but it is possible to scan the outside of the upper arm 61 and the area around the shoulder.
[0073] With this configuration, it is possible to scan areas that are difficult to scan properly in a position with the arms close to the body, such as the inner part of the arm. In other words, if there are areas that are difficult to scan in a particular position, the body can be changed to a position where 3D scanning is possible for those areas, and the other areas can be scanned in the specific position. This makes it possible to obtain the desired 3D scan model and improve the accuracy of the scan data.
[0074] In this embodiment, a scan was performed with the armpit closed (S13) after a scan with the armpit abducted (S12), but the order of these scans may be reversed.
[0075] Returning to Figure 3, once the scan with the armpit closed is complete, the prosthetic hand maker imports the point cloud data and surface images scanned by the 3D scanner 20 as scan data into the information processing device 10 (S15). As a result, the information processing device 10 acquires the scan data.
[0076] This configuration allows for the acquisition of body shape in various positions, enabling flexible post-processing of the images.
[0077] Once the import into the information processing device 10 is complete, the prosthetic hand maker uses the information processing device 10 to generate 3D data (or a 3D model) based on the scan data (S16). Specifically, the point cloud data is converted into 3D polygon data, and predetermined post-processing is performed. Post-processing includes, for example, data adjustments such as smoothing out unnecessary bumps and repairing holes, which are performed by the information processing device 10. The information processing device 10 may also perform a process to automatically convert data into 3D data when data is imported from the 3D scanner 20.
[0078] Once the 3D data generation process is complete, the prosthetic hand creator aligns and combines the 3D model obtained by scanning the upper arm 61 in an abducted state and the 3D model obtained by scanning the upper arm in a closed state on the information processing device 10, and performs a process to generate a thin surface that will be the inner surface of the prosthetic hand socket, which will be the contact surface with the body (S17).
[0079] More specifically, the 3D model obtained by scanning the upper arm 61 in an abducted state and the 3D model obtained by scanning the upper arm with the armpit closed are displayed on the display screen of the 3D CAD running on the information processing device 10. Surface images of the body are also displayed on this 3D CAD. Therefore, the prosthetic arm maker can perform positioning based on the shape of each 3D model and / or markings on the body.
[0080] With this configuration, a natural-looking synthetic body model can be created from body parts in different positions through alignment. In particular, alignment can be easily performed using markings on the body surface as a guide.
[0081] Furthermore, after alignment, the prosthetic arm maker combines the two models by specifying the shape of the shoulder area of the 3D model obtained by scanning with the armpit closed and the shape of the upper arm 62 (outer and inner sides of the upper arm 62) of the 3D model obtained with the armpit open, thereby generating a single surface 650. This surface 650 is a plane with no thickness or volume.
[0082] With this configuration, it is possible to generate a shape for the upper arm prosthesis socket that improves the quality of fit to the body by taking into account changes in the shape of the body surface due to changes in limb position, such as sagging of fat due to opening the armpits, and the protrusion and recession of shoulder and arm muscles.
[0083] Figure 7 is an explanatory diagram of the surface 650 relating to the upper arm 61 generated by synthesis. Figure 7(a) is a front view of the surface 650, and Figure 7(b) is a side view of the surface 650. The surface 650 has the shape of a 3D model obtained by scanning with the armpit closed around the shoulder, and the shape of a 3D model obtained by scanning with the armpit open in other parts.
[0084] Once the generation of surface 650 is complete, the prosthetic arm maker generates a three-dimensional model of the upper arm prosthesis socket based on surface 650 in a three-dimensional CAD system (S18). More specifically, a predetermined processing program is used to apply a predetermined thickness to surface 650, thereby generating a three-dimensional model of the upper arm prosthesis socket with surface 650 as its inner surface.
[0085] In this case, the processing program can employ various known methods. For example, it may be a process that uniformly applies a constant thickness to the surface 650, or it may apply different thicknesses based on predetermined rules. Alternatively, it may apply a predetermined thickness based on machine learning techniques.
[0086] Figure 8 is an explanatory diagram of a three-dimensional model relating to the upper arm prosthesis socket 680. Figure (a) is a front view of the upper arm prosthesis socket 680, and Figure (b) is a side view of the upper arm prosthesis socket 680. As is clear from the figure, the upper arm prosthesis socket 680 has a shape in which a predetermined thickness is given to the surface 650.
[0087] Returning to Figure 3, after generating the 3D model, the prosthetic hand creator converts the 3D data of the upper arm prosthetic socket 680 into a data format for 3D printing on the information processing device 10 and outputs it using the 3D printer 30 (S19). By combining this outputted upper arm prosthetic socket with other prosthetic hand components, the final prosthetic hand can be manufactured.
[0088] With this configuration, device models can be materialized using a 3D printer. This enables the manufacturing of devices at a lower cost.
[0089] With the above configuration, it is possible to generate a device shape based on 3D body shape data that combines the 3D shapes of parts of the body in multiple different limb positions. This allows for the design of a device that takes into account changes in body shape caused by changes in limb position. As a result, the fitting quality of the device worn on the body can be improved.
[0090] In this embodiment, the case of upper arm amputation was used as an example. That is, the case where there is not enough space around the armpit to perform a three-dimensional scan when the arm is tucked in or not abducted was described, but the present invention can be applied to similar cases. For example, in the case of transfemoral amputation, it may be difficult to perform a three-dimensional scan of the inside of the thigh when the legs are closed. In such cases, a three-dimensional scan of the inside of the thigh can be performed by performing a three-dimensional scan with the legs open, i.e., with the thigh abducted.
[0091] (2. Second Embodiment) In the first embodiment, multiple scans were performed on a part of the body to obtain multiple scan data, and a composite body model was synthesized by combining parts of the corresponding 3D models to generate a surface. In this embodiment, an example of generating a surface and a device model from a single scan data obtained from a single scan will be described.
[0092] (2.1 Configuration of the Upper Arm Prosthesis Manufacturing System) The prosthetic arm manufacturing system according to this embodiment has substantially the same configuration as the upper arm prosthesis manufacturing system 100 according to the first embodiment, so a detailed explanation will be omitted.
[0093] (2.2 Method for Manufacturing an Upper Arm Prosthesis) Figure 9 is a flowchart showing the method for manufacturing a prosthesis according to this embodiment. As is clear from the figure, first, the prosthesis maker makes a predetermined mark on the body, including the vicinity of the stump, as in the first embodiment (S21).
[0094] After the marking process, the prosthetic arm maker uses a 3D scanner 20 to scan the portion of the upper arm 61 from the inner side (or the side facing the trunk 62) to the front, while the upper arm is in an abducted position (or with the armpit open) (S22). In this embodiment, the scan data includes point cloud data relating to the 3D shape and image data relating to the surface of the body.
[0095] In this embodiment, after the scan, the prosthetic hand maker pauses the 3D scanner 20 and has the subject close their armpit (S23).
[0096] After having the subject close their armpit, the prosthetic arm maker resumes the scanning operation of the 3D scanner 20 and scans the outer side of the upper arm 61 and the shoulder area while the armpit is closed (S25). In this embodiment, the scan data includes point cloud data relating to the 3D shape and image data relating to the surface of the body.
[0097] In other words, these scans, interspersed with pauses, can generate a single scan data set based on the data before and after the pause. Note that pausing and resuming the scan may be done multiple times, not just once.
[0098] With this configuration, body parts in different positions can be easily synthesized using scanning techniques.
[0099] Once the scan is complete, the prosthetic hand maker imports the scan data from the 3D scanner 20 to the information processing device 10 on the information processing device 10 (S26). This scan data includes point cloud data relating to the 3D shape and image data relating to the surface of the body.
[0100] Once the import into the information processing device 10 is complete, the prosthetic hand creator uses the information processing device 10 to generate 3D data (or a 3D model) based on the scan data (S27). Specifically, the point cloud data is converted into 3D polygon data, and predetermined post-processing is performed. Post-processing includes, for example, data adjustment such as smoothing out unnecessary bumps and repairing holes, which is performed by the information processing device 10. Once this 3D model generation process is complete, the prosthetic hand creator extracts the outer surface of the 3D model on the information processing device 10 to generate a thin surface that will be the contact surface with the body, i.e., the inner surface of the prosthetic hand socket (S27). The information processing device 10 may automatically perform the conversion to 3D data and surface extraction when data is imported from the 3D scanner 20.
[0101] Once the surface generation is complete, the prosthetic arm maker generates a three-dimensional model of the upper arm prosthesis socket based on the surface using a three-dimensional CAD program executed on the information processing device 10 (S28). More specifically, a predetermined processing program is used to assign a predetermined thickness to the surface, thereby generating a three-dimensional model of the upper arm prosthesis socket with the surface as its inner surface.
[0102] In this case, the processing program can employ various known methods. For example, it may be a process that uniformly applies a constant thickness to the surface, or it may apply different thicknesses based on predetermined rules. Alternatively, it may apply a predetermined thickness based on machine learning techniques.
[0103] After generating a three-dimensional model of the upper arm prosthesis socket, the prosthetic hand manufacturer converts the three-dimensional data of the upper arm prosthesis socket into a data format for three-dimensional printing on the information processing device 10 and outputs it using the three-dimensional printer 30 (S29). By combining this outputted upper arm prosthesis socket with other prosthetic hand components, the final prosthetic hand can be manufactured.
[0104] With this configuration, device models can be materialized using a 3D printer. This enables the manufacturing of devices at a lower cost.
[0105] With this configuration, the device shape can be generated based on 3D body shape data that is a composite of the 3D shapes of parts of the body in multiple different limb positions. This allows for the design of a device that takes into account changes in body shape caused by changes in limb position. As a result, the fitting quality of the device worn on the body can be improved.
[0106] (3. Third Embodiment) As a third embodiment, an example of applying the present invention to a manufacturing system and manufacturing method for a lower leg prosthesis or a part thereof (e.g., a socket) as an example of a body-worn device will be described.
[0107] (3.1 Configuration of the Lower Leg Prosthesis Manufacturing System) The prosthesis manufacturing system according to this embodiment has substantially the same configuration as the upper arm prosthesis manufacturing system 100 according to the first embodiment, so a detailed explanation will be omitted.
[0108] (3.2 Method for Manufacturing a Lower Leg Prosthesis) Figure 10 is a flowchart showing the method for manufacturing a lower leg prosthesis according to this embodiment. As is clear from the figure, in this embodiment, the prosthesis maker first makes a predetermined mark on the body, including the vicinity of the lower leg stump (S31). In this embodiment, the marking is made based on information regarding the position and extent of subcutaneous tissue (including bone, tendon, fat, or muscle, etc.). The marking also functions as information for obtaining alignment, and in this embodiment, it is drawn directly on the body surface using a pen or the like.
[0109] Figure 11 is an explanatory diagram showing an example of marking applied to the body surface from the thigh 71 to the stump 75 of the lower leg 73. Figure (a) is a perspective view of the medial side of the lower leg as seen from the right front, and Figure (b) is a perspective view of the lateral side of the lower leg as seen from the left front.
[0110] As is clear from Figure (a), a patellar line 701 indicating the patella is drawn in the central part of the frontal view of the knee 72, and a patellar tendon line 702 indicating the patellar tendon is drawn on the side of the stump 75 from the patellar tendon line 701. On the frontal view of the lower leg 73, on the side of the stump 75 from the patellar tendon line 702, a tibial ridge line 704 extends longitudinally. At the knee 72 end of the tibial ridge line 704, a tibial tuberosity line 703 indicating the tibial tuberosity is drawn, and at the stump 75 end, a tibial epiphysis line 706 indicating the tibial end is drawn perpendicular to the tibial ridge line 704. On the medial side of the thigh 71, a femoral condyle upper edge line 708 indicating the upper edge of the femoral condyle is drawn, and on the medial side of the lower leg 73, a tibial medial edge line 705 indicating the medial edge of the tibia is drawn.
[0111] Furthermore, as is clear from Figure (b), a line 708 indicating the upper edge of the femoral condyle is drawn on the lateral side of the thigh 71. Also, on the lateral surface from the knee 72 to the lower leg 73, slightly lateral to the patellar tendon line 702, a line 709 indicating the lateral condyle of the patella is drawn, and further lateral, slightly toward the stump 75, a line 710 indicating the fibular head is drawn. Slightly lateral to the tibial crest 704, a line 707 indicating the lateral edge of the tibia is drawn along the tibial crest 704.
[0112] Returning to Figure 10, once the marking is complete, the prosthesis maker uses the 3D scanner 20 to 3D scan the thigh 71 (or proximal portion), knee 72, and lower leg 73 (or distal portion) of the leg, which are in a slightly flexed (or mildly flexed) position, and acquire point cloud data (S32). At this time, the flexion angle of the knee 72 is, for example, about 10°. In this embodiment, although the flexion angle is about 10°, the knee 72 may be fully extended, or other shallow flexion angles may be used.
[0113] At the same time, the 3D scanner 20 acquires an image of the body surface along with the 3D point cloud data. This makes it possible to obtain an image of the marked body surface.
[0114] Figure 12 is a side view of a leg with the knee 72 slightly flexed. As is clear from the figure, the thigh 71, knee 72, and lower leg 73 can be scanned with the knee 72 slightly flexed.
[0115] Returning to Figure 10, once the scan with the knee 72 slightly flexed is complete, the prosthesis maker then uses the 3D scanner 20 to perform a 3D scan of the thigh 71, knee 72, and lower leg 73 of the leg with the knee fully flexed to acquire point cloud data (S33). At this time, the flexion angle of the knee 72 is, for example, about 80°, taking into consideration the shape of the proximal end of the lower leg prosthesis socket.
[0116] At the same time, the 3D scanner 20 acquires an image of the body surface along with the 3D point cloud data. This makes it possible to obtain an image of the marked body surface.
[0117] Figure 13 is a side view of a leg with the knee 72 in a fully flexed position. As is clear from the figure, the thigh 71, knee 72, and lower leg 73 can be scanned in this fully flexed position.
[0118] In this embodiment, a scan was performed with the knee slightly flexed (S32), followed by a scan with the knee fully flexed (S33). However, this order may be reversed.
[0119] Returning to Figure 10, once the scan with the knee 72 fully flexed is complete, the point cloud data and surface images scanned by the 3D scanner 20 are imported as scan data into the information processing device 10, respectively (S35).
[0120] This configuration allows for the acquisition of body shape in various positions, enabling flexible post-processing of the images.
[0121] Once the import into the information processing device 10 is complete, the prosthetic leg maker uses the information processing device 10 to generate 3D data (or a 3D model) based on the scan data (S37). Specifically, the point cloud data is converted into 3D polygon data, and predetermined post-processing is performed. Post-processing includes, for example, data adjustments such as smoothing out unnecessary bumps and repairing holes, which are performed by the information processing device 10. The information processing device 10 may also perform a process to automatically convert data into 3D data when data is imported from the 3D scanner 20.
[0122] Once the 3D data generation process is complete, the prosthetic leg maker displays a 3D model of the leg with the knee 72 slightly bent and a 3D model of the leg with the knee 72 fully bent on the display screen of the 3D CAD running on the information processing device 10. Subsequently, the prosthetic leg maker aligns each 3D model based on its shape and / or surface image (body markings), etc., using the information processing device 10.
[0123] With this configuration, a natural-looking synthetic body model can be created from body parts in different positions through alignment. In particular, alignment can be easily performed using markings on the body surface as a guide.
[0124] After alignment, the prosthesis maker selects the shape of the knee 72' and lower leg 73' of a 3D model with the knee 72 slightly flexed for the region from the knee 72 to the stump 75, and the shape of the thigh 71'' of a 3D model with the knee 72 fully flexed for the thigh 71, thereby combining them into a single 3D model. By extracting the outer surface of this combined 3D model, a single surface is generated (S37). This surface has no thickness or volume and becomes the inner circumferential surface of the lower leg prosthesis socket, which is the contact surface with the body. Furthermore, the shape of this surface may be made editable in 3D CAD for the creation of the lower leg prosthesis socket described later.
[0125] Figure 14 is an explanatory diagram showing the process of 3D model synthesis performed on the information processing device 10. As is clear from the figure, on the 3D CAD display screen, a 3D model of a leg with the knee 72 slightly bent (10°) (71', 72', 73') (depicted as a solid grid in the figure) and a 3D model of a leg with the knee 72 significantly bent (80°) (71'', 72'', 73'') (depicted as a dashed grid in the figure) are displayed superimposed.
[0126] In this embodiment, in order to create the proximal end shape of the lower leg prosthesis socket, a 3D model portion (71'') of the thigh 71 with the knee 72 in a greatly flexed state is selected. For the other parts (i.e., the portion from the knee 72 to the lower leg 73), a 3D model portion (71'') of the knee 72 in a slightly flexed state is selected. Through this selection, the selected 3D model portions are combined and synthesized.
[0127] Figure 15 is an explanatory diagram showing an example of a surface 760 created in the process described above. Figure 15(a) is a front view of the surface 760, and Figure 15(b) is a side view of the surface 760. As is clear from the figure, the surface 760 is made up of a thin surface and is hollow. The area of the surface 760 near the thigh is based on the shape of the thigh 71 when the knee 72 is greatly flexed (71''), and the other parts are based on the shape of the thigh 71 when the knee 72 is slightly flexed (71'). As a result, the width of the opening near the thigh of the surface 760 is larger than the width of the thigh 71 when the knee 72 is slightly flexed.
[0128] In the example shown in the figure, a support portion 762 is provided on the surface 760 in the area corresponding to the back of the knee, based on the shape (71'') of the thigh 71 when the knee 72 is greatly flexed. The support portion 762 is configured to protrude radially and support a portion of the thigh. In addition, in the example shown in the figure, a recess 761 is provided on the surface 760 in the area corresponding to the patellar tendon, by editing the shape of the surface 760 to match the patellar tendon.
[0129] Returning to Figure 10, once the generation of surface 760 is complete, the prosthesis maker generates a three-dimensional model of the lower leg prosthesis socket based on surface 760 in a three-dimensional CAD system (S38). More specifically, a predetermined processing program is used to apply a predetermined thickness to surface 760, thereby generating a three-dimensional model of the lower leg prosthesis socket with surface 760 as its inner surface.
[0130] In this case, the processing program can employ various known methods. For example, it may be a process that uniformly applies a constant thickness to the surface 760, or it may apply different thicknesses based on predetermined rules. Alternatively, it may apply a predetermined thickness based on machine learning techniques.
[0131] Figure 16 is an explanatory diagram of a three-dimensional model relating to the lower leg prosthesis socket 780. Figure (a) is a front view, and Figure (b) is a side view. As is clear from the figure, the lower leg prosthesis socket 780 has a shape in which a predetermined thickness is given to the surface 760.
[0132] Returning to Figure 10, after generating the 3D model, the prosthesis maker converts the 3D data of the lower leg prosthesis socket 780 into a data format for 3D printing on the information processing device 10 and outputs it using the 3D printer 30 (S39). By combining this outputted upper arm prosthesis socket with other prosthetic components, the final prosthesis can be manufactured.
[0133] With this configuration, device models can be materialized using a 3D printer. This enables the manufacturing of devices at a lower cost.
[0134] Figure 17 is an explanatory diagram illustrating the operation of a lower leg prosthesis socket manufactured by the manufacturing method according to this embodiment. Figure 17(a) is a perspective view with the knee 72 slightly bent, and Figure 17(b) is a perspective view with the knee 72 fully bent. As is clear from the figure, the shape of the lower leg prosthesis socket near the thigh 71 is generated based on a three-dimensional model of the knee 72 fully bent. As a result, the width between the side walls (or between the wings) of the proximal edge of the lower leg prosthesis socket is made large, so that the part of the thigh 71 or knee 72 from the side to the back fits the shape of the lower leg prosthesis socket. As a result, the wings prevent the foot from being injured, feeling compressed, or being pinched. In addition, damage to the lower leg prosthesis socket due to the generation of excessive stress can be prevented.
[0135] With the above configuration, it is possible to generate a device shape based on 3D body shape data that combines the 3D shapes of parts of the body in multiple different limb positions. This allows for the design of a device that takes into account changes in body shape caused by changes in limb position. As a result, the fitting quality of the device worn on the body can be improved.
[0136] In this embodiment, we have shown an example of 3D scanning performed with the knee joint slightly flexed (10°) and significantly flexed (80°) for the purpose of creating a lower leg prosthesis. However, the present invention can be applied to a variety of objects. For example, to create a forearm prosthesis, 3D scanning may be performed with the elbow joint flexed to approximately 45° and with the elbow joint flexed to 90°. Similarly, to create a transfemoral prosthesis, 3D scanning may be performed with the hip joint in an intermediate position and with the hip joint flexed to 90°.
[0137] Furthermore, when creating the same lower leg prosthesis, 3D scanning may be performed with the knee joint in a slightly flexed position, both in a relaxed state and in a state where the gastrocnemius muscle is isometrically contracted. In this case, the shape of the relaxed leg is used as the basic shape, and the shape of the inner circumferential surface on the back of the lower leg prosthesis socket is designed to match the raised gastrocnemius muscle, thereby improving the fitting quality.
[0138] (4. Fourth Embodiment) In the third embodiment, multiple scan data were acquired for a part of the body, namely the part from the thigh to the lower leg, and a body model was synthesized by combining parts of the 3D model corresponding to the acquired scan data, and a surface was generated. However, similar to the second embodiment, one scan data may be generated by repeatedly pausing and resuming the scan, and a device model may be generated based on that scan data to create one surface.
[0139] (5. Fifth Embodiment) In the first to fourth embodiments, a three-dimensional scanner 20 was used to scan changes in the surface shape of the body due to changes in limb position (or changes in joint angles) and to generate a three-dimensional model of the device. In this embodiment, as an example of changes in the surface shape of the body due to other factors, an example of scanning changes in the surface shape of the body caused by bringing a jig into contact with the body will be described.
[0140] In creating an upper arm prosthesis, a flat plate with its longitudinal direction in the anterior-posterior direction is sometimes placed under the armpit to take a mold in order to form a plane in the axillary region that determines the direction of movement. In this embodiment, an example of 3D scanning of the upper arm with a flat plate placed under the armpit as a jig for creating an upper arm prosthesis is described.
[0141] (5.1 Configuration of the Upper Arm Prosthesis Manufacturing System) The upper arm prosthesis manufacturing system according to this embodiment is substantially the same as the configuration of the upper arm prosthesis manufacturing system 100 according to the first embodiment, so a detailed explanation will be omitted.
[0142] (5.2 Method for Manufacturing an Upper Arm Prosthesis) The method for manufacturing an upper arm prosthesis according to this embodiment is substantially the same as that of the first embodiment, except for the scanning steps (S12, S13) (see Figure 3).
[0143] In other words, first, marking is performed on the body surface of the upper arm 61, similar to the first embodiment (S11).
[0144] Once marking is complete, the prosthetic arm maker uses a 3D scanner 20 to scan the entire area from the shoulder to the upper arm 61 in an abducted position (i.e., with the armpit open) to acquire point cloud data. At this time, the angle at which the armpit is opened is set to approximately 20° to 30°, taking into consideration the minimization of deformation near the shoulder and the limits of what the 3D scanner 20 can scan on the inside of the upper arm 61. At this time, the 3D scanner 20 also acquires an image of the body surface in addition to the 3D point cloud data. As will be described later, this makes it possible to obtain an image of the marked body surface.
[0145] Once the scan with the upper arm 61 in an abducted position is complete, the prosthetic arm maker then uses the 3D scanner 20 to scan the outer side of the upper arm 61 and the shoulder area with the plate placed under the armpit, and acquires point cloud data. Note that the soft tissue on the inner side (side of the body) of the upper arm 61 is deformed (i.e., crushed) due to the plate being placed under the armpit, and the surface shape is changed. At this time, the 3D scanner 20 also acquires an image of the body surface along with the 3D point cloud data. As will be described later, this makes it possible to obtain an image of the marked body surface.
[0146] In this embodiment, a scan was performed with the limb abducted, followed by a scan with the flat plate closed to the side. However, the order of these scans may be reversed.
[0147] The subsequent processing is the same as in the first embodiment (S15-S19). That is, after importing the scan data into the information processing device 10, a three-dimensional model of the upper arm 61 is generated, a three-dimensional model of the upper arm prosthesis socket is generated based on these, and these are output using the three-dimensional printer 30.
[0148] With this configuration, it is possible to obtain scan data of the upper arm 61 in an abducted state and scan data of the upper arm 61 with a flat plate placed under the armpit. Therefore, the soft tissue of the upper arm 61 can be identified by examining the deformation of the surface shape of the upper arm 61 deformed by the flat plate. This makes it possible to manufacture a prosthetic socket that fits the upper arm 61 while taking the soft tissue into consideration. For example, it becomes possible to correct one set of scan data with the other set of scan data.
[0149] (6. Sixth Embodiment) In the first to fourth embodiments, a three-dimensional scanner 20 was used to scan changes in the surface shape of the body due to changes in limb position (or changes in joint angles) and to generate a three-dimensional model of the device. In this embodiment, as an example of changes in the surface shape of the body due to other factors, an example of scanning changes in the surface shape of the body caused by wearing a body-worn device will be described. A body-worn device (which may also be called an interface) is a covering material or a shrinkable compression garment that covers a part of the body, and includes, for example, liners, stamp socks, stockings, leggings, stamp shrinkers, etc.
[0150] When wearing a prosthetic leg, a liner may be worn to protect the stump. In this embodiment, an example of 3D scanning of the lower leg before and after liner application is described when creating a lower leg prosthetic socket.
[0151] (6.1 Configuration of the Lower Leg Prosthesis Manufacturing System) The lower leg prosthesis manufacturing system according to this embodiment is substantially the same as the configuration of the prosthesis manufacturing system 100 according to the third embodiment, so a detailed explanation will be omitted.
[0152] (6.2 Method for Manufacturing a Lower Leg Prosthesis) The method for manufacturing a lower leg prosthesis according to this embodiment is substantially the same as that of the third embodiment, except for the scanning steps (S32, S33) (see Figure 10).
[0153] In other words, first, marking is performed on the body, including the vicinity of the stump of the lower leg, similar to the third embodiment (S31).
[0154] Once marking is complete, the prosthesis maker uses a 3D scanner 20 to scan the entire area from the thigh 71 to the lower leg 73, which is in a slightly flexed state, and acquires point cloud data. The flexion angle of the knee 72 is, for example, 10°. At this time, the 3D scanner 20 also acquires an image of the body surface along with the 3D point cloud data. As will be described later, this makes it possible to obtain an image of the marked body surface.
[0155] Once the scan in a slightly flexed position is complete, the prosthesis maker then fits the liner onto the subject's stump. The prosthesis maker then uses a 3D scanner 20 to scan the entire area from the thigh 71 to the lower leg 73, where the liner is fitted and the leg is slightly flexed, to acquire point cloud data. At this time, the liner surface is marked based on the location and extent of subcutaneous tissue (including bone, tendons, fat, or muscle). The 3D scanner 20 acquires an image of the liner surface along with the 3D point cloud data. As will be described later, this allows for the acquisition of an image of the marked liner surface.
[0156] In this embodiment, a scan was performed with the liner installed first, followed by a scan with the liner installed. However, the order of these scans may be reversed.
[0157] The subsequent processing is substantially the same as in the third embodiment (S35-S39). That is, after importing the scan data into the information processing device 10, a three-dimensional model of the portion from the thigh 71 to the lower leg 73 is generated, a three-dimensional model of the lower leg prosthesis socket is generated based on these, and output using the three-dimensional printer 30.
[0158] With this configuration, it is possible to obtain scan data of the portion from the thigh 71 to the lower leg 73 before the liner is attached, and scan data of the portion from the thigh 71 to the lower leg 73 after the liner is attached. Therefore, it is possible to manufacture a prosthetic socket that fits the lower leg 73, taking into account the deformation of the surface shape caused by the attachment of the liner.
[0159] (7. Modifications) The present invention can be implemented in various modified forms.
[0160] The embodiments described above focused on changes in the shape of a part of the body due to changes in limb position, but the present invention is not limited to such configurations. Therefore, the present invention may be applied to changes in the surface shape of the body due to different factors. Even without changing limb position, the surface shape of a part of the body can change. For example, when a user of a device applies or releases force to a part of their body, the surface of that part of the body may bulge or sink, potentially changing the surface shape of the body. Also, when some external force is applied by a device such as a blood pressure monitor or jig, the surface shape of the body may change. Three-dimensional scans may be performed before and after these changes in the shape of a part of the body, and the device may be manufactured using the results, similar to the embodiments described above.
[0161] In Embodiments 1 and 3 described above, a single surface was generated by combining different parts of multiple body models in different limb positions, and a body-worn device was generated based on that surface. However, the present invention is not limited to such configurations. Therefore, for example, a body-worn device may be directly generated from a combination of surfaces of multiple body models in different limb positions without creating a single surface.
[0162] The embodiments described above mainly describe examples in which markings are made directly on a part of the body using a pen or the like, but the present invention is not limited to such configurations. Therefore, for example, as shown in the sixth embodiment, an interface (or body attachment) with a predetermined pattern or marking may be attached to a part of the body, and the interface may be scanned as an image using a three-dimensional scanner 20. In this case, the pattern or marking on the interface is based on information regarding the position, extent, etc., of subcutaneous tissue (including bone, tendon, fat, or muscle, etc.), similar to the markings made on a part of the body. It may also include regular patterns such as grids.
[0163] With this configuration, the patterns displayed on the interface make it easy to align 3D models related to scan data.
[0164] Furthermore, the interface may be a compression-type interface, as shown in the sixth embodiment.
[0165] With this configuration, it is possible to prevent or reduce the displacement of the interface relative to the body caused by changes in limb position.
[0166] Furthermore, instead of marking directly on a part of the body or marking on an interface attached to a part of the body, a marker used for positioning, etc., may be used. This marker may be detachable from a part of the body and may be, for example, a circular or annular sticker.
[0167] With this configuration, referencing markers makes it easy to align 3D models related to scan data.
[0168] In the embodiments described above, alignment was performed based on images of a part of the body and / or the shape of a part of the body, but the present invention is not limited to such configurations. Therefore, for example, instead of or in addition to such information, deep tissue information about a part of the body may be presented, and the model may be aligned based on the deep tissue information. Subcutaneous deep tissue information includes, for example, information on the location and extent of bones, tendons, fat, or muscles. Various methods can be used to calculate deep tissue information, but for example, it may be generated by performing predetermined image processing on scan images with different conditions such as limb position. Alternatively, deep tissue information may be acquired separately by CT or the like.
[0169] With this configuration, deep information makes it easier to align the 3D models related to each scan data, for example.
[0170] In the above-described embodiment, a body model is generated and a device model is generated based on an image of a part of the body and / or the shape of a part of the body. However, soft tissue information may also be presented to the designer. When the position of the body changes, the soft tissues of the body sag or move due to the effects of gravity, etc. By acquiring multiple body shapes in different positions, it is possible to detect the changes in these soft tissue areas and the differences between them and other areas, thereby identifying the soft tissue areas. These soft tissue areas may be presented to the user as reference information for design. Any means of presentation is acceptable, but for example, the parts corresponding to the soft tissues in a 3D body model on 3D CAD may be highlighted. This information may also be used for alignment.
[0171] 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.
[0172] This invention is applicable to industries that manufacture body-worn devices including prosthetics, orthotics, or parts thereof.
[0173] 10 Information processing device 11 Processor 12 Memory unit 13 Communication unit 15 Display control unit 16 I / O processing unit 20 3D scanner 30 3D printer 40 Input device 50 Display device 61 Upper arm 62 Torso (chest) 63 Stump 650 Surface 680 Upper arm prosthesis socket 71 Thigh 72 Knee 73 Lower leg 75 Stump 760 Surface 780 Lower leg prosthesis 100 Device manufacturing system
Claims
1. A method for manufacturing a device, comprising: a scanning step of scanning a part of the body before and after a change using a three-dimensional scanner; and a device model generation step of generating a device model, which is a three-dimensional model of a device to be attached to the part of the body, based on a body model, which is a three-dimensional model relating to the scan data obtained by the scan.
2. The manufacturing method according to claim 1, further comprising a device output step of outputting the device model using a three-dimensional printer.
3. The manufacturing method according to claim 1, wherein the scan data is a single scan data obtained by scanning a part of the body in one state, pausing the scan, and then scanning a part of the body in another state, or by repeating the process.
4. The manufacturing method according to claim 1, wherein the scan data is a plurality of scan data, including scan data obtained by scanning the part of the body before the change and scan data obtained by scanning the part of the body after the change.
5. The manufacturing method according to any one of claims 1, 3, or 4, wherein the change is a change in the position of a part of the body.
6. The manufacturing method according to claim 5, wherein the limb position includes a limb position in which there is insufficient space to perform a three-dimensional scan and there are parts of the body that are difficult to scan in three dimensions.
7. The manufacturing method according to any one of claims 1, 3, or 4, wherein the change is contact of the jig with a part of the body.
8. The manufacturing method according to any one of claims 1, 3, or 4, wherein the change is the attachment of a pressure garment to the part of the body.
9. The manufacturing method according to claim 4, wherein the device model generation step further comprises a synthetic body model generation step of generating a synthetic body model by combining a part of each of the body models relating to each of the scan data, and the device model is generated based on the synthetic body model.
10. The manufacturing method according to claim 9, wherein in the step of generating a synthetic body model, the generation of the synthetic body model is performed after aligning each of the body models on a three-dimensional CAD.
11. The manufacturing method according to claim 10, wherein the alignment is performed based on the shape of each body model and a marking attached to a part of the body.
12. The manufacturing method according to claim 11, wherein the marking is a marking directly applied to a part of the body or a marking applied to an interface attached to a part of the body.
13. The manufacturing method according to claim 11, wherein the marking is a marker directly attached to the part of the body or a marker attached to an interface attached to the part of the body.
14. The manufacturing method according to claim 12 or 13, wherein the markings are affixed to the part of the body based on the location of bones, tendons, fat, or muscles.
15. The manufacturing method according to claim 10, wherein the alignment is performed based on deep tissue information relating to the part of the body.
16. The manufacturing method according to claim 15, wherein the deep information includes information relating to the location of bones, tendons, fat, or muscles.
17. The manufacturing method according to claim 4, wherein the device model generation step further comprises a soft tissue information provision step, which provides information about soft tissue identified based on the plurality of scan data.
18. The manufacturing method according to claim 1, wherein the change is a change in the position of a part of the body, and the body model is a model obtained by combining different parts of the body when they are in different positions.
19. The manufacturing method according to claim 1, wherein the part of the body includes a joint, the change is a change in the position of the part of the body, the position includes a position in which the joint is at a first angle and a position in which the joint is at a second angle different from the first angle, and the shape of the device model is based on at least the body model relating to the position in which the joint is at the first angle and the body model relating to the position in which the joint is at the second angle.
20. The manufacturing method according to claim 1, wherein the device is a prosthesis, an orthotic device, or a part thereof.
21. A device manufacturing apparatus comprising: a scan data acquisition unit that acquires scan data obtained by scanning a part of the body before and after a change using a three-dimensional scanner; and a device model generation unit that generates a device model, which is a three-dimensional model of a device to be attached to the part of the body, based on a body model, which is a three-dimensional model relating to the scan data.
22. A method for manufacturing a device, comprising: a scan data acquisition step of acquiring scan data obtained by scanning a part of the body before and after a change using a three-dimensional scanner; and a device model generation step of generating a device model, which is a three-dimensional model of a device to be attached to the part of the body, based on a body model, which is a three-dimensional model relating to the scan data.
23. A device manufacturing program comprising: a scan data acquisition step of acquiring scan data obtained by scanning a part of the body before and after a change using a three-dimensional scanner; and a device model generation step of generating a device model, which is a three-dimensional model of a device to be attached to the part of the body, based on a body model, which is a three-dimensional model relating to the scan data.