Method, device and computer program for creating manufacturing data for an orthopaedic product

Abstract

Method for generating manufacturing data (17) for manufacturing an orthopaedic product for a body part (1) of a patient, the method comprising the following steps: - providing a digital three-dimensional body part model (300) of the body part (1) for which the orthopaedic product is intended to an electronic data processing system (11), wherein the three-dimensional body part model (300) is based on external body part data acquired from the body part (1) of the patient; - identifying at least one rigid body part area on the provided body part model (300) using the electronic data processing system (11), wherein, based on the identified rigid body part areas (320), the remaining area lying outside the rigid body part areas (320) is identified as a flexible body part area (330);- Creating a reduced three-dimensional body part model (310) using the electronic data processing system (11) depending on the provided three-dimensional body part model (300), the identified rigid body part areas (320) and a reduction metric (13) applied in the area of ​​the flexible body part area (330); and - Generating manufacturing data (17) for the orthopaedic product based on the reduced three-dimensional body part model (310) using the electronic data processing system (11), characterized in that at least one joint axis of a joint of the body part (1) is simulated in the digital three-dimensional body part model (300) using the electronic data processing system (11), so that the digital three-dimensional body part model (33) can be moved about the at least one joint axis into a starting position.

Description

[0001] The invention relates to a method for generating manufacturing data for the production of an orthopaedic product for a patient's body part. The invention also relates to a device and a computer program for this purpose.

[0002] Orthopedic products, as defined in the present invention, are in particular orthoses and prostheses. Orthoses are products that support, protect, or restrict the movement of a patient's body part, for example a joint, in order to prevent overuse. Prostheses, on the other hand, replace missing or no longer present body parts of the patient.

[0003] In the following, the term "patient" refers to any user of the orthopaedic product. This therefore refers to the wearer of the product to be manufactured.

[0004] Every orthotic device is placed on a part of the patient's body. It does not necessarily have to come into contact with the patient's skin. Orthoses, for example, are often worn over clothing, so that the clothing, such as trousers, is positioned between the orthotic device and the patient's skin. Nevertheless, a knee orthosis, for instance, is attached to the patient's knee or leg. A prosthesis always has an interface element that connects to an amputation stump or another body part and is attached to that part. For example, a prosthetic socket is used for a leg prosthesis, forming the interface between the prosthesis and the amputation stump. In this case, the amputation stump would be the patient's body part.A liner is usually used between the skin surface of the patient's amputation stump and the prosthetic socket to reduce shear forces acting on the skin.

[0005] A prosthetic socket for an amputation stump is typically made of a rigid (virtually non-deformable) material, such as a fiber-reinforced plastic, and forms an important part of the interface between the amputation stump and the prosthesis, which is attached to the socket. Such prosthetic sockets have long been used, particularly for leg prostheses intended for use on an amputation stump, for example, a thigh stump. However, the invention is not limited to this type of prosthetic socket. Prosthetic sockets of the type described here can also be used for arm or lower leg prostheses.

[0006] Prosthetic sockets for leg amputees are subject to particular stresses in daily use. When walking, the patient's entire weight rests on the prosthetic socket, and thus especially on the amputation stump, which is positioned within the socket. It is therefore of utmost importance to adapt the prosthetic socket as optimally as possible to the individual characteristics and needs of the patient, particularly to the shape and geometry of the affected body part.

[0007] Several different methods are known from the current state of the art for adapting the shape and design of the prosthetic socket to the amputation stump under load. This usually involves taking a mold of the amputation stump to obtain a blank and base body upon which the prosthetic socket is built. The dominant method is still taking a plaster cast of the stump to create a negative mold. Besides its low cost, this method has the advantage that experienced orthotists can influence the shape of the future prosthetic socket by precisely shaping the amputation stump during the plaster casting process. This is particularly advantageous when the socket is intended to have specific load-bearing zones.

[0008] To apply the most even pressure possible to the amputation stump, methods have been increasingly developed that exert uniform pressure on the stump while its shape is being shaped. For example, the stump is placed in a water-filled container so that the water exerts even pressure. Alternatively, a container filled with sand can be used. However, a disadvantage of these methods is that their design makes them difficult to transport and therefore they are rarely used in everyday clinical practice.

[0009] Optical scanning methods, in which the amputation stump is measured using optical camera devices, are known from the prior art. However, even if such a method is applicable, the amputation stump is only measured statically. Acquiring data during the movement of the amputation stump is generally not possible. Furthermore, it is generally not possible to deform the amputation stump, for example, by applying pressure with the hands, and then capture the deformed stump.

[0010] All the aforementioned methods, which are known from the prior art, suffer from the disadvantage that the impression taken of the body part in question, particularly an amputation stump, fails to account for the loads that occur on the body part during intended use. Consequently, the resulting models only inadequately represent reality. Therefore, the expertise of an orthotist must be relied upon when manufacturing an orthopedic product. For this reason, a test socket is often created first, which must be tested and worn by the patient. This allows for verification of whether the socket meets the requirements or whether modifications are necessary. If the test socket reveals problems or suboptimal shapes, its shape may need to be adapted to a dynamic situation. This is time-consuming and costly.

[0011] German patent DE 10 2019 122 374 A1 discloses a method for manufacturing an orthopaedic product for a patient's body part, in which body part data is displayed from the current viewing direction using a display device in such a way that the user sees the body part and the body part data superimposed. Based on the displayed data, production data is then generated and a corresponding orthopaedic product is manufactured.

[0012] German patent DE 10 2019 109 781 A1 discloses a method for creating manufacturing data for the production of an orthopaedic device, which can be manufactured using the generated manufacturing data in an automated manufacturing process. Based on a digital functional form, which includes a 3D body part model, a digital volume model of the orthopaedic device to be manufactured is created, and the digital manufacturing data is generated from the digital volume model.

[0013] The invention is therefore based on the objective of proposing a method for manufacturing an orthopaedic product for a part of a patient's body that eliminates or at least mitigates the disadvantages.

[0014] The problem is solved by the method according to claim 1 according to the invention. Advantageous embodiments of the invention are found in the corresponding dependent claims.

[0015] According to claim 1, a method for generating manufacturing data for the production of an orthotic product for a patient's body part is proposed, in which a digital three-dimensional model of the body part in question, for which the orthotic product is intended, is first provided to an electronic data processing system. The digital three-dimensional model of the body part includes, in particular, the external shape and geometry of the patient's body part and thus represents a digital impression of the body part. This digital impression was specifically created without any additional stress being placed on the body part. Rather, it is a model of the body part in its unloaded state.The three-dimensional body part model is based on external body part data captured from the patient's body part, which can be obtained, for example, using a digital scan. Other imaging techniques or impression-taking mechanisms are also conceivable.

[0016] A liner may have been placed over the body part beforehand, and its elasticity influences the shape of the body part to some extent. Since the liner is often worn under the subsequent orthotic device (also called an orthopedic appliance), it is advisable to include it in the impression (e.g., scan). Ideally, the same liner used for this is always the one that will later be worn under the orthotic device.

[0017] Subsequently, one or more rigid body part areas are identified on the body part model. These areas, due to their anatomical structure, do not yield, or only yield minimally, under pressure. Unlike muscle tissue, connective tissue, soft tissue, and similar structures (flexible body part areas), these rigid body part areas do not experience compression when the orthotic product is used and are therefore only conditionally suitable for load bearing. Such rigid body part areas are generally formed by rigid body structures located directly or very close to the skin, such as scar tissue or bone. Based on the identified rigid body part areas, the remaining areas outside these rigid body part areas are identified as flexible body part areas. These flexible body part areas are those parts of the body part that yield under load or pressure.They can yield to pressure and be compressed. Such yielding body parts are characterized in particular by muscle tissue, connective tissue, and other soft tissue.

[0018] Finally, a reduced three-dimensional model of the body part is created, which digitally replicates the body part under load or stress with regard to its shape and geometry. This reduction ensures that the orthotic product later fits securely and correctly on the body part and can bear loads. In particular, the loads generated during use of a prosthesis must be reliably transferred to the body part. This reduced three-dimensional model is created based on the provided 3D body part data, the identified rigid body part areas, and a reduction metric.The reduction metric is applied to a specific area of ​​the compliant body part to account for any yielding of these areas by the orthotic product itself during subsequent use, as these areas are best suited to bear loads. This can encompass the entire compliant body part area or only a portion thereof.

[0019] Based on the created reduced three-dimensional body part model, the manufacturing data for the industrial production of the orthopaedic product is then generated.

[0020] The present invention makes it possible to generate manufacturing data for an orthotic product that is individually adapted to a specific patient's body part, thereby overcoming the disadvantages of prior art methods for molding the body part in an unloaded state. Using reduction metrics, the yielding of soft body parts can be specifically compensated for, while rigid body parts can be disregarded during this reduction process, resulting in exceptional wearing comfort. The inventive method is particularly suitable for the automated production of such orthotic products, eliminating the need for test products. Time-consuming manual rework is therefore unnecessary.

[0021] A user (for example, an orthopaedic technician) of the procedure can thus create an orthopaedic product that takes into account the compressions and deformations that occur when the body part is under stress and compensates accordingly for good and safe wearing comfort, without the user of the procedure having to develop a prototype of the orthopaedic product for the patient.

[0022] The body part can be an arm, for example an upper arm or forearm, a leg, for example a thigh or lower leg, or a joint, for example a hip joint, a knee, an ankle joint, or an elbow. Particularly for prostheses and prosthetic sockets, the body part can also be an amputation stump, for example a thigh stump, a lower leg stump, or an arm stump.

[0023] The identification of rigid and, conversely, flexible body parts is automated using an electronic data processing system, resulting in a fully automated process for manufacturing an orthotic product. It is possible that markings have been applied to the body part to facilitate the automated identification of the position of the anatomical areas, particularly the rigid body parts. In this case, the orientation and / or extent of the rigid body parts are automatically determined by the electronic data processing system and assigned to their respective positions.

[0024] The three-dimensional body part model is reduced in selected areas of the compliant body part regions according to the reduction metric, resulting in a reduced circumference and / or volume of the three-dimensional body part model. Reducing the volume of the three-dimensional body part model in these compliant areas ensures a secure fit of the product on the body part and simulates the load-bearing forces experienced during use of the orthotic device, which is then incorporated into the design of the orthotic device to be manufactured. The result is the reduced three-dimensional body part model.

[0025] According to one embodiment, an orthopaedic product manufactured based on the production data is provided. The creation of the orthopaedic product based on the production data generated according to the invention can, in particular, be carried out in an automated manufacturing process in which the orthopaedic product is manufactured essentially without human intervention. Such an orthopaedic product can also be a physical model that represents a copy of the body part and is used to manufacture a prosthesis or orthosis.

[0026] An automated manufacturing process using an automated manufacturing system refers specifically to a process in which the orthotic device is manufactured without human intervention or cognitive input. Such an automated manufacturing process can be, for example, an additive or generative manufacturing process, such as 3D printing. Subtractive processes, such as CNC milling, are also conceivable. These automated manufacturing processes can also be collectively referred to as "rapid manufacturing processes."

[0027] In this process, either the orthotic product itself can be manufactured, or a physical model of the body part is first created as an intermediate step from the manufacturing data, based on which the orthotic product is then manufactured (for example, by deep drawing). Therefore, the manufacturing data within the meaning of the present invention includes not only data that directly serve to manufacture the orthotic product, but also manufacturing data with which intermediate products, such as a physical model of the body part, can be produced, and based on these intermediate products, the actual orthotic product is then manufactured.

[0028] In addition, orthosis components such as splint systems, joints, shells, or other parts can be manufactured to accommodate the individual characteristics of the patient, including the size and length of specific body parts like arms and legs, the position and orientation of different body parts relative to each other, and the range of motion and limitations of movement, for example, of joints. This is particularly advantageous for shells, which are ordered and fitted directly to a specific body part of the patient and come into direct contact with that body part during subsequent use of the orthotic product.

[0029] According to one embodiment, providing the body part model includes capturing body part data based on a digital scan of the patient's relevant body part using a scanning device, and creating the three-dimensional body part model based on the captured body part data using the electronic data processing system. The scan typically involves the body part plus the liner that is applied to the patient's skin over the body part.

[0030] The acquisition of body part data can be achieved, for example, using a scanning device. This could be a scan liner or a scan glove. If the body part in question is, for instance, an amputation stump, a scan liner can be used. This liner is pulled over the stump and is capable of capturing its own geometric shape. This can be done, for example, using strain gauges within the liner that determine the distance between precisely defined points on the liner. If this is done over a sufficiently large portion of the liner, preferably over the entire liner, the contour and geometric shape of the liner, and thus also the geometric shape and contour of the amputation stump contained within the liner, can be determined.

[0031] Alternatively or additionally, scanning gloves can also be used on existing body parts, such as arms, legs, feet, or joints. These gloves are equipped with sensors that can measure and determine absolute positions, allowing the geometric shape and outer contour of the body part to be captured and measured. This is achieved, for example, by the user of the procedure stroking the skin of the body part while wearing a scanning glove.

[0032] Examples of sensors used in the scan glove or scan liner include fiber Bragg sensors, ultrasound sensors, or magnetic sensors, which can detect the external shape of the body part.

[0033] Preferably, the body part data is 3-dimensional body part data.

[0034] According to one embodiment, at least one joint axis of a joint of the body part is simulated in the digital three-dimensional body part model by means of the electronic data processing system, so that the digital three-dimensional body part model can be moved about the at least one joint axis into a starting position. The movement of the body part model about the joint axis can be performed automatically by the electronic data processing system.

[0035] Joint axes are preferably detected automatically by the electronic data processing system. This can be achieved, for example, using an enhanced body part model. A generic anatomical model, which may contain information about the joint axes as well as other details such as the position of bones and soft tissues, is modified and individualized using the scan data. As a result, the outer contour corresponds to the scan data, while the additional information from the enhanced body part model can be utilized. The digital body part model can be rotated and positioned optimally to ensure the production of the manufacturing data. This is because the patient's position is often difficult to control during scanning and can result in unfavorable or extreme flexion positions, which can alter the body part in ways undesirable for manufacturing.For a knee joint, for example, a starting position is provided in which the flexion position is between 10° and 15°.

[0036] According to one embodiment, the three-dimensional body part model is superimposed on the at least one identified rigid body part area and displayed on a screen connected to the electronic data processing system.

[0037] The procedure displays to the user which areas are rigid body parts unaffected by the reduction metric and which areas have been identified as more compliant and subject to reduction based on the reduction metric. The result of the reduction can also be displayed to the user, for example, by overlaying the original, unaltered body part model with the reduced body part model based on the reduction metric. If necessary, the user can manually intervene and further reduce or weaken specific areas that, based on their experience and comprehensive knowledge of the patient, are subject to greater compression.

[0038] This allows the user of the procedure, for example an orthotist, to manually modify the data to accommodate specific characteristics of the body part. For instance, the user can add markings to the body part model that will later be considered when generating the reduced three-dimensional model. This makes it possible, for example, to mark areas where padding will be applied. Similarly, different materials to be used in the product can be assigned to different areas in this way.

[0039] Furthermore, it can be useful to make additional modifications to the digital body part model during the procedure. For example, it may be helpful to change the length of the body part to accommodate the different compression properties of various liners or to account for anticipated changes in the soft tissue distribution within the body part. When making such changes, it is advisable to exclude rigid body part areas, as these cannot be lengthened. Changing the length can achieve a redistribution of soft tissue volume. It can also be beneficial to increase the size of the body part areas identified as rigid (e.g., by making the shaft wider so that no or less pressure is exerted on these areas) to provide additional relief in these sensitive regions.

[0040] In the case of a lower leg shaft, three rigid areas are of particular importance and are identified accordingly by the procedure: the fibular head, tibia, and patella. In the case of a forearm, these are the epicondyles of the humerus and the olecranon.

[0041] According to one embodiment, the orientation and / or extent of the at least one rigid body part area in relation to the body part model is automatically determined by means of the electronic data processing system. For this purpose, corresponding markings can be provided on the digital three-dimensional body part model O, which are used for the particularly automated identification of the position of the rigid body part areas.

[0042] According to one embodiment, anatomical body part data of the patient's body part are provided to the electronic data processing system, whereby the rigid body part areas on the provided body part model are automatically identified by the electronic data processing system depending on the provided anatomical body part data.

[0043] The provision of anatomical body part data can be based, for example, on a medical imaging procedure and is stored, for instance, in an electronic data storage device accessible to the electronic data processing system. The medical procedure could be, for example, a CT scan (CT: computed tomography), an MRI scan (MRI: magnetic resonance imaging), or another imaging procedure. This data is often already available, as it was acquired and recorded after the operation. Alternatively or additionally, the corresponding body part data can be acquired and subsequently provided using the procedure described here.

[0044] Alternatively or additionally, it is also conceivable that, based on the patient's three-dimensional body part model, the known orientation of the body part model, and basic anatomical knowledge of the body part represented by the three-dimensional model, the rigid structures contained within it, such as bone structures, could be automatically determined and serve as a basis for identifying the rigid body part areas. While this does not use the patient's exact data, it is sufficient in most cases for a good approximation in determining the rigid body part areas.

[0045] According to one embodiment, before creating the reduced three-dimensional body part model based on the reduction metric, the three-dimensional body part model is reduced in at least a portion of the compliant body part area. It can be provided that the three-dimensional body part model is copied, with the corresponding reduction being performed only on the copy. The copy can be supplemented with further properties, such as joint axes, to allow the body part model to be moved in accordance with the body part being represented. This also makes it possible to recognize and identify areas that require special attention due to movement around the joint axis. In particular, this also makes it possible to automatically identify recess areas to allow sufficient movement around the joint axis.

[0046] According to one embodiment, the reduction metric is based on a reduction of less than 10%, preferably less than 8%. The percentage can refer to the circumference at the specific position to be reduced or to the overall volume of the body part model.

[0047] According to one embodiment, the degree of reduction varies from proximal to distal along the length of the body part, based on the reduction metric. The reduction metric is therefore designed such that, starting from a position on the body part model, the reduction changes from proximal to distal along the length of the body part.

[0048] According to one embodiment, the degree of reduction is determined based on the reduction metric, depending on the reduction position at which reduction is to be applied. This allows the degree of reduction to change depending on the position on the body part model.

[0049] Whether the degree of reduction, for example by what percentage of the circumference or volume is to be removed at the respective position, varies within the compliant body part areas and depends on the position within the body part model.

[0050] According to one embodiment, a reduction metric is selected from a plurality of reduction metrics depending on the liner material. Different reduction metrics can be created for different liner materials, with the appropriate reduction metric being selected depending on the material used.

[0051] Therefore, the choice of reduction metric depends on the liner material, particularly its flowability, especially with flowing liner materials such as polymers, polyurethanes, and copolymers, where a lower reduction is intended proximally than distally, increasing from proximal to distal. The liner material is flowable and, due to the greater reduction distally, is intended to flow upwards.

[0052] According to one embodiment, a reduction metric is selected from a multitude of reduction metrics depending on a property of the body part. Such a property could be, for example, the shape of the body part, so that conical shapes are reduced more than cylindrical ones. Properties such as body part geometry and soft tissue condition can thus be used as a basis for selecting an appropriate reduction metric. The selection of the reduction metric can also depend on the soft tissue status or condition, with, for example, atrophied and normal body parts being reduced more than body parts with a high proportion of soft tissue.

[0053] According to one embodiment, it is provided that, in order to create the reduced three-dimensional body part model using the electronic data processing system, in a first step the reduction metric is applied in the area of ​​the compliant body part area and in a second step at least one rigid body part area is increased.

[0054] According to one embodiment, it is provided that the length of the body part model is adjusted in a further step, while the body part areas identified as rigid remain unchanged.

[0055] According to one embodiment, the body part is an amputation stump and the orthopaedic product is a socket, preferably for the lower extremities.

[0056] According to one embodiment, it is provided that more than one, preferably two, particularly preferably three rigid areas are identified.

[0057] The problem is also solved by the device according to claim 16 for carrying out the method described above, wherein the device has at least one electronic data processing system for performing the method. The electronic data processing system can be connected to a scanning device for capturing external body part data and optionally to a manufacturing system for automatically producing the orthopaedic product based on the generated manufacturing data.

[0058] The problem is also solved with the computer program according to claim 17, wherein the computer program has program code means which are configured to carry out the above-described method when the computer program is executed on a data processing system.

[0059] The present invention will now be explained in more detail by way of example with the aid of the accompanying figures. These show: Fig. 1. Schematic representation of process flows; Fig. 2. Display of scan data from a scan; Fig. 3. Representation of an avatar Fig. 4. Representation of a body part model Fig. 5. Representation of a body part model with rigid body part areas Fig. 6. Presentation of the reduction in comparison

[0060] Fig. Figure 1 schematically shows a setup and process flow of the present invention. A body part 1 of a patient (not shown) is digitally scanned using a scanning device 10. The resulting scan data is transmitted to an electronic data processing unit 11, which, with its electronic computing unit 12, can execute the present method. In the exemplary embodiment of the Fig. 1 concerns body part 1, an amputation stump of a leg.

[0061] The electronic computing unit 12 of the electronic data processing system 11 is provided with a reduction metric 13 for the execution of the present procedure, in order to perform the reduction of the body part model according to the reduction metric 13. It is conceivable that several reduction metrics are provided, whereby different reduction metrics are selected depending on the property of the body part in question, for example geometry, soft tissue condition and / or liner material.

[0062] Furthermore, corresponding anatomical body part data from a medical procedure 14 can be provided to the electronic data processing system 11 so that the rigid body part areas can be identified accordingly. It is also conceivable that data corresponding to body part 1 can be provided to the electronic computing unit 12 using a database 15, enabling the automated determination of rigid body part areas.

[0063] Using a display 16, the respective process steps can be shown to a user of the present procedure and the possibility can be given to intervene in the production of the models and data.

[0064] Once the relevant manufacturing data has been generated using the electronic computing unit 12 of the electronic data processing system 11, it can be transmitted to an automated manufacturing system 17 so that a corresponding orthopaedic product can be created based on the manufacturing data. The step of the automated manufacturing system 17 can involve creating a mold of the body part 1 in an automated manufacturing process based on the reduced 3-dimensional body part model, similar to how a mold of the body part 1 can be produced using plaster. The orthopaedic product in question can then be manufactured based on this body part mold.The manufactured body part shape, which was created on the reduced three-dimensional body part model, includes the deformation of body part 1 under load and thus explicitly adapts to the needs of the patient.

[0065] In the Fig. 2 to Fig. Section 6 now illustrates the process flow up to the production of the reduced 3-dimensional product model.

[0066] Fig. Figure 2 shows a digital scan 100 of body part 1 for which an orthotic product is to be manufactured. The body part that was digitally captured for the production of the digital scan 100 is an amputation stump of a leg, where the amputation was made below the knee.

[0067] The Fig. The two markings shown can be applied by a user of the procedure, for example an orthopaedic technician, and can represent boundary boundaries or, if necessary, rigid body part areas.

[0068] Subsequently, based on this scan data, also referred to as external body part data, a so-called Avatar 200 is created, which is then displayed in Fig. Figure 3 is shown, and unlike the scan model, movement properties are implemented. For example, the avatar can be rotated, and movements can be performed within the model itself. A joint axis can be inserted into the avatar, allowing movements of the body part to be digitally mapped using the existing joint. In this way, the scan can be taken in the simplest position, but the avatar can then still be moved into the necessary position for the shaft construction.

[0069] Rigid structures, such as bones or scar tissue, as well as flexible body parts such as muscles, connective tissue and soft tissues can be superimposed in the avatar.

[0070] Once the avatar 200 has been aligned accordingly, a digital three-dimensional body part model 300 is created based on it. This is in Fig. Figure 4 is shown. Scan data 100 and avatar 200 remain unchanged. This is in Fig. 4 shown.

[0071] The rigid body part areas 320 are then identified, as in Fig. Figure 5 illustrates this. In the present embodiment, the rigid body part is the kneecap (patella), which was identified based on anatomical body part data provided by the patient or generally. Markings made by the orthotist can also serve as indicators. The remaining areas are identified as flexible body part areas 330.

[0072] It is possible for the user of the method to manually adjust the dimensions of the rigid body part regions 320 if the automated detection was not satisfactory. Subsequently, for the present embodiment, the further rigid body part regions tibia (shinbone) and fibula head (calfbone) can be identified and, if necessary, manually adjusted (not shown). In the present embodiment, a total of 3 rigid body part regions are thus identified.

[0073] According to the reduction metric, the body part model is now reduced to generate a reduced body part model 310. As in Fig. Figure 6 is shown. It can be seen in Fig. 6 the difference between the reduced body part model 310 and the original body part model 300, whereby no reduction has taken place in the area of ​​the rigid body part areas.

[0074] The reduction, according to the reduction metric, depends on the location or position within the body part model. It can be stipulated that the reduction decreases from distal to proximal. For example, it can be stipulated that a maximum reduction of 5% is applied starting proximally, increasing to up to 10% at the maximum distal point, while rigid body part areas are not reduced.

[0075] The rigid body parts can now also be adjusted to allow for enlargement. This is more in line with the usual process of first reducing everything and then reapplying in certain areas. Here, this is an optional step. In any case, reduction in the rigid body parts is prevented. Furthermore, it ensures that the desired overall reduction is achieved. Reference symbol list 1 body part 10 Scanning device 11 electronic data processing system 12 electronic computing unit 13 Reduction metric 14 medical procedures 15 database 16 Display 17 anatomical manufacturing data 100 digital scans 200 Avatar 300 digital body part models 310 reduced digital body part model 320 rigid body part areas 330 compliant body part areas QUOTES INCLUDED IN THE DESCRIPTION

[0000] This list of documents cited by the applicant was automatically generated and is included solely for the reader's convenience. The list is not part of the German patent or utility model application. The DPMA accepts no liability for any errors or omissions. Cited patent literature

[0000] DE 102019122374 A1

[0011] DE 102019109781 A1

[0012]

Claims

[1] Method for creating manufacturing data (17) for manufacturing an orthopaedic product for a body part (1) of a patient, the method comprising the following steps: - providing a digital three-dimensional body part model (300) of the relevant body part (1) for which the orthopaedic product is intended to an electronic data processing system (11), wherein the three-dimensional body part model (300) is based on external body part data recorded on the body part (1) of the patient; - identifying at least one rigid body part region on the provided body part model (300) by means of the electronic data processing system (11), wherein on the basis of the identified rigid body part regions (320), the remaining region lying outside the rigid body part regions (320) is identified as a flexible body part region (330); - creating a reduced three-dimensional body part model (310) by means of the electronic data processing system (11) as a function of the provided three-dimensional body part model (300), the identified rigid body part regions (320) and a reduction metric (13) applied in the region of the flexible body part region (330); and - generating production data (17) for the orthopaedic product on the basis of the reduced three-dimensional body part model (310) by means of the electronic data processing system (11). [2] Method according to claim 1, characterized by Providing an orthopaedic product manufactured on the basis of the manufacturing data (17). [3] Method according to claim 1 or 2, characterized bythat the provision of the body part model (300) comprises the acquisition of body part data based on a digital scan (100) of the relevant body part (1) of the patient by means of a scanning device (10) and the creation of the three-dimensional body part model (300) as a function of the acquired body part data by means of the electronic data processing system (11). [4] Method according to one of the preceding claims, characterized by that at least one joint axis of a joint of the body part (1) is simulated in the digital three-dimensional body part model (300) by means of the electronic data processing system (11), so that the digital three-dimensional body part model (33) can be moved about the at least one joint axis into an initial position. [5] Method according to one of the preceding claims, characterized bythat the three-dimensional body part model (300) is displayed superimposed with the at least one identified rigid body part region on a display (16) connected to the electronic data processing system (11). [6] Method according to one of the preceding claims, characterized by that the orientation and / or extent of the at least one rigid body part region in relation to the body part model is automatically determined by means of the electronic data processing system. [7] Method according to one of the preceding claims, characterized by that anatomical body part data of the body part (1) of the patient are provided to the electronic data processing system (11), wherein the rigid body part regions (320) on the provided body part model (300) are automatically identified by means of the electronic data processing system (11) as a function of the provided anatomical body part data. [8] Method according to claim 7, characterized by that the anatomical body part data were obtained by a medical imaging procedure (14) or were obtained as part of the procedure before being provided. [9] Method according to one of the preceding claims, characterized by in that, in order to create the reduced three-dimensional body part model (310) based on the reduction metric (13), the three-dimensional body part model (300) is reduced in at least a part of the flexible body part region (330). [10] Method according to one of the preceding claims, characterized by that based on the reduction metric (13) less than 10%, preferably less than 8% is reduced. [11] Method according to one of the preceding claims, characterized by that based on the reduction metric (13) the degree of reduction varies across the body part length from proximal to distal. [12] Method according to one of the preceding claims, characterized by that based on the reduction metric (13) a degree of reduction is determined depending on a reduction position at which reduction is to take place. [13] Method according to one of the preceding claims, characterized by that a reduction metric is selected from a variety of reduction metrics depending on a liner material. [14] Method according to one of the preceding claims, characterized by that depending on a property of the body part, a reduction metric is selected from a plurality of reduction metrics. [15] Method according to one of the preceding claims, characterized byin that, in order to create the reduced three-dimensional body part model (310) by means of the electronic data processing system (11), in a first step the reduction metric (13) is applied in the region of the flexible body part region (330) and in a second step at least one rigid body part region (320) is increased. [16] Apparatus for carrying out the method according to one of claims 1 to 15. [17] Computer program with program code means arranged to carry out the method according to one of claims 1 to 15, when the computer program is executed on a data processing system (11).

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