Methods for creating manufacturing data and computer programs, as well as methods for manufacturing an orthopaedic device

Abstract

Method for generating manufacturing data (40) for the manufacture of an orthopaedic device (100) which can be manufactured using the generated manufacturing data (40) in an automated manufacturing process, the method comprising the following steps: - Providing a digital form (10) in a data processing system (30), wherein the digital form (10) includes a 3D body part model (20) of a body part for which the orthotic device (100) is intended, - automatic creation of a digital volume model (19) of the orthopaedic device (100) to be manufactured based on the 3D body part model (20) of the provided digital purpose form (10) using the data processing system (30), and - Generating the digital manufacturing data (40) from the digital volume model (19) using the data processing system (30), characterized in that the digital functional form (10) is provided such that a plurality of markings (11, 12) are provided on the 3D body part model (20), wherein the boundary of the orthopaedic device (100) is generated manually or automatically by means of the data processing system (30) depending on the markings (11, 12) provided on the 3D body part model (20), and / or wherein a plurality of anatomical features (11) are automatically recognized as markings based on the 3D body part model (20) of the provided digital functional form (10) by means of the data processing system (30) and subsequently the boundary of the orthopaedic device (100) is generated depending on the recognized anatomical features.

Description

[0001] The invention relates to a method for creating manufacturing data for the production of an orthopedic device that can be manufactured using the created manufacturing data in an automated manufacturing process. The invention also relates to a computer program for this purpose.

[0002] The invention also relates to a method for manufacturing an orthopaedic device based on the created manufacturing data.

[0003] Orthopedic devices, such as orthoses, prostheses, or exoskeletons, must be developed and adapted precisely and accurately to the prevailing conditions of the disabled person. Even today, numerous manual and hand-carrying steps are still required to manufacture such an orthopedic device.

[0004] In practice, this involves first creating a negative impression of a body part from a molding compound, which is then cast, for example, using plaster. This body part model is usually adapted or slightly modified by an orthopedic technician with knowledge of a known medical indication or desired support effect, so that the subsequent orthopedic device, such as an orthosis, can fulfill its medical purpose or its intended support effect. The model of the body part in question, adapted to the medical indication, is also called a functional mold.

[0005] Based on the functional form produced in this way, the orthopaedic device for the handicapped person is now developed and manufactured by adapting the orthopaedic device with its shape, geometry and dimensions to the functional form produced.

[0006] The disadvantage is that the manufacturing process for such an orthopedic device requires many weeks or even months before the device can be handed over to the disabled person. This is due to the fact that several different groups of people are involved in the entire process, each with different tasks in the creation of the orthopedic device. Adjustments that become necessary during the process therefore require a considerable amount of time before the person or group of people in question can take on the task.

[0007] The subsequently published DE 102017 131 323 A1 discloses a method for producing an orthopedic device, wherein scan data from a patient is first acquired and then a surface mesh of the patient is created. The surface mesh can be adjusted to make appropriate corrections for errors that occurred during the scan of the patient's body part.

[0008] Against this background, it is the object of the present invention to provide an improved method for manufacturing an orthopaedic device with which the orthopaedic device to be manufactured can be produced significantly faster and more cost-efficiently.

[0009] The object is achieved according to the invention with the method for creating production data according to claim 1, with the computer program according to claim 11, and with the method for manufacturing an orthopedic device according to claim 12. Advantageous embodiments of the invention can be found in the corresponding subclaims.

[0010] According to claim 1, a method for creating manufacturing data for the production of an orthopedic device is proposed, wherein the orthopedic device is to be manufactured using the created manufacturing data in an automated manufacturing process. The manufacturing data therefore serves as the basis for controlling an automated manufacturing system that executes the automated manufacturing process for manufacturing the orthopedic device. Such manufacturing data can, for example, be computer models, on the basis of which control signals are generated for controlling the automated manufacturing system for manufacturing the orthopedic device. However, the manufacturing data can also already contain such control signals or consist of such control signals.For example, the manufacturing data can also be a computer model that is then loaded into so-called slicer software, which divides the model into individual layers to control a 3D printer.

[0011] An automated manufacturing process using an automated production facility is understood to mean, in particular, a process in which the orthopedic device is manufactured without the intervention of human intelligence and without manual intervention. Such an automated manufacturing process can, for example, be an additive or generative manufacturing process, such as 3D printing. Subtractive processes such as CNC milling are also conceivable. Such automated manufacturing processes can also be summarized under the term "rapid manufacturing process."

[0012] An orthopedic device within the meaning of the present invention can, as already briefly indicated above, be an orthosis or prosthesis. An orthosis as an orthopedic device can, for example, be a foot orthosis, hand orthosis, knee orthosis, torso orthosis, or head orthosis. However, this list is not intended to be exhaustive.

[0013] Exoskeletons that are attached to the outside of a part or the entire body of the wearer and are intended to enable movements and / or activities that the body can no longer perform itself are also considered orthopedic devices within the meaning of this invention. This also includes devices that make it easier for the wearer to perform strenuous, strenuous, or tiring activities, such as overhead work, better, more easily, and for longer.

[0014] According to the invention, it is now proposed that the method for creating production data is first provided with a digital Zweckform in a data processing system, wherein the digital Zweckform contains a 3D body part model of a body part for which the orthopedic device is intended. Providing the digital Zweckform also includes creating the Zweckform or the 3D body part model. The creation of the Zweckform can also be automated by the data processing system.

[0015] A digital volume model of the orthopedic device to be manufactured is then automatically created using the data processing system based on the 3D body part model of the provided digital Zweckform. The digital volume model is automatically created by the data processing system based on the shape, geometry, and dimensions of the digital Zweckform provided in the data processing system, so that the digital volume model corresponds to a digital twin of the orthopedic device to be manufactured.

[0016] The digital volume model contains model data of the orthopedic device to be manufactured and is calculated by the data processing system without human intervention and preferably without manual intervention. The basis for the calculation is the digital functional form, to which the digital volume model is adapted for the manufacture of the orthopedic device.

[0017] Based on the digital volume model created automatically in this way, the digital production data is now generated by the data processing system, which then forms the basis for controlling the production system for the automated production of the orthopaedic device in an automated production process.

[0018] The present invention thus makes it possible to manufacture an orthopedic device, such as an orthosis or prosthesis, quickly and efficiently, so that such an orthopedic device can now be delivered to the disabled person within a few days. Creating the manufacturing data takes only a few minutes with a provided digital form. Through the interplay of automatically creating a digital volume model, generating the digital manufacturing data based on the digital volume model, and applying the created manufacturing data in an automated manufacturing process, an orthopedic device can be physically manufactured almost fully automatically, significantly reducing manufacturing and processing times.

[0019] According to one embodiment, a digital surface model of the orthopedic device to be manufactured is first automatically created using the data processing system based on the 3D body part model of the provided digital Zweckform and an edge boundary of the orthopedic device specified on the 3D body part model. The edge boundaries can be specified on the 3D body part model or on the digital Zweckform. However, it is also conceivable, as will be shown later, that the edge boundaries on the 3D body part model are automatically generated by the data processing system.

[0020] Based on the resulting surface model, which forms the interior of the orthopedic device to be manufactured, the digital volume model is automatically created using the data processing system, taking into account a specified material thickness of the orthopedic device to be manufactured. The interior of the orthopedic device refers to the side facing the body part of the disabled person. Additional elements, such as padding or insoles, can be arranged between the interior of the orthopedic device and the body part.

[0021] Accordingly, it is conceivable and advantageous to create the surface model depending on additional elements that are to be arranged between the orthopedic device and the body part of the disabled person, so that the surface model is adapted accordingly, especially in those areas where the additional elements are to be provided. This allows the surface model to accommodate the padding or insoles of the orthopedic device in the designated locations without the orthopedic device exerting pressure on these areas.

[0022] According to the invention, the digital Zweckform is provided in such a way that a plurality of markings are provided on the 3D body part model, wherein the edge boundary of the orthopedic device is generated manually or automatically by means of the data processing system depending on the markings provided on the 3D body part model. Such markings, as can also be found on real Zweckforms of an orthopedic technician, provide specific reference points for the dimensions of an orthopedic device, so that the edge boundary of the orthopedic device can be generated on their basis, in particular automatically. It is of course conceivable that the automatically generated edge boundary can be adapted by a technician in order to accommodate specific customer requirements.

[0023] In this context, the invention encompasses the automatic recognition of a plurality of anatomical features of a body part by means of the data processing system based on the 3D body part model of the provided digital Zweckform, and the subsequent generation of the edge boundary depending on the recognized anatomical features. These anatomically recognized features thus form the markings often defined by an orthopedic technician on the Zweckform. This makes it possible to manufacture an orthopedic device, such as an orthosis, fully automatically, without the need for additional manual process steps, for example, based on a scan of a body part.

[0024] It is thus possible, in particular, to produce a prosthesis or an orthosis without making a real model of the body part in question and to produce the prosthesis or orthosis for this real body part model.

[0025] As already mentioned, in one embodiment, the surface model and / or the volume model is further created using the data processing system, taking into account at least one predefined padding area, area of ​​varying wall thickness, reinforcement area, perforation area, bulge area, joint area, and / or an area intended for the integration of additional components or semi-finished products. This makes it possible, after the manufacture of the orthopedic device, to add further elements to the orthopedic device using the created production data in an automated manufacturing process, or to produce an orthopedic device that has precisely these special features.

[0026] It can be provided that one or more of these aforementioned areas are manually specified on the 3D body part model of the digital Zweckform. It is thus conceivable that with the help of the data processing system, a technician marks corresponding areas on the 3D body part model of the digital Zweckform displayed on a monitor, which are then taken into account as special areas when creating the surface model and / or the volume model. However, it is also conceivable that with the help of the data processing system, a technician marks corresponding areas on the surface model and / or volume model displayed on a monitor that are to have the special properties as described above. Based on this, the adapted surface model and / or volume model can then be recalculated if necessary.

[0027] According to one embodiment, it can alternatively or additionally be provided that one or more of the aforementioned regions are automatically specified depending on one or more markings and / or depending on anatomical features recognized by the data processing system based on the 3D body part model. In this case, the data processing system is configured to automatically recognize the regions based on corresponding markings on the digital Zweckform or the 3D body part model and / or recognized anatomical features and to automatically consider them when creating the surface model or the volume model.

[0028] According to a further embodiment, the digital surface model and / or the digital volume model of the orthopedic device to be manufactured is automatically created based on a predefined base model. Such a base model relates to the properties of the respective body part of the disabled person. For example, in the case of an orthosis as the orthopedic device, a distinction can be made between a foot orthosis and a hand orthosis as the base model. This can improve the creation of the volume model. The specification of the base model can be incorporated into the overall process at the beginning as an input parameter.

[0029] It is also conceivable that the aforementioned areas are defined based on a previously selected basic model of the orthopedic device to be manufactured. In this case, corresponding areas are marked on the basic model, which are then transferred to the areas of the Zweckform or the 3D body part model.

[0030] In a further embodiment, the predefined or to be predefined basic model is automatically selected by the data processing system from a plurality of basic models provided to the data processing system in a data storage device, depending on the 3D body part model. Thus, in this embodiment, the data processing system is configured to analyze the shape and geometry of the body part model based on the 3D body part model of the digital Zweckform provided to the data processing system and, in doing so, to identify which basic model of an orthopedic device provided to the data processing system best matches the guardian geometry of the body part model in terms of its basic shape and geometry. This basic model is then selected for the further process and used as the basis for creating the production data.

[0031] According to a further embodiment, it is provided that a digital surface model and / or the digital volume model of the orthopedic device to be manufactured is automatically created, furthermore based on knowledge of a predetermined medical indication. Thus, based on knowledge of the medical indication of the disabled person, specific areas can be automatically specified in the surface model and / or volume model, in which specific additional elements for the orthopedic device are inserted, which represent necessary treatment measures based on the medical indication. The additional elements required for the orthopedic device, which are to be inserted in the automatically specified areas after the manufacture of the orthopedic device, therefore constitute the measures resulting from the medical indication.The medical indication can still be used as a basis for selecting the appropriate model from various basic models.

[0032] As an alternative to a medical indication, a desired support effect can also serve as an input variable, for example in the case of orthoses or exoskeletons intended for preventive support.

[0033] In a further embodiment, it is provided that the digital functional form is provided by scanning the relevant body part of the handicapped person using a scanning device and then generating the 3D body part model depending thereon.

[0034] The problem is also solved by the computer program according to claim 13 for implementing the aforementioned method for creating production data when the computer program is executed on a data processing system. The computer program can advantageously be stored on a data storage medium.

[0035] The object is also achieved according to the invention with the method for manufacturing an orthopedic device according to claim 14, wherein firstly the manufacturing data for the orthopedic device are created using the method as described above. Subsequently, these manufacturing data are fed to an automated manufacturing system which is configured to manufacture the orthopedic device using the created manufacturing data in an automated manufacturing process. Such a manufacturing system can be, for example, a 3D printer. Such manufacturing systems are known, for example, under the term additive or generative manufacturing systems. By feeding the manufacturing data to the automated manufacturing system, the orthopedic device is then manufactured by the automated manufacturing process in accordance with the supplied manufacturing data.

[0036] The invention is explained in more detail by way of example with reference to the accompanying figures. They show: Fig. 1 schematic representation of the process sequence according to the invention; Fig. 2 Representation of a 3D body part model of a Zweckform; Fig. 3 Representation of anatomical and product-specific markings on the Zweckform 3D body part model; Fig. 4 Representation of edge boundaries on the Zweckform 3D body part model; Fig. 5 Representation of special or product-specific areas; Fig. 6 Representation of the possibility of manual modification; Fig. 7 Representation of a calculated volume model.

[0037] Fig. Figure 1 shows a schematic representation of the method according to the invention, which begins with the provision of a digital Zweckform 10. The digital Zweckform has a 3D body part model 20, which represents a 3-dimensional image of the relevant body part of the handicapped person. In the exemplary embodiment of the Fig. 1, the digital Zweckform 10 is a foot for which a foot orthosis is to be made.

[0038] Ideally, the digital functional form already has a shape and geometry that is intended to treat the medical indication of the disabled person as a measure. The digital functional form therefore has a shape and geometry that then leads to a corresponding shape and geometry of the orthosis that can be used to treat the medical indication of the disabled person and thus represents the appropriate treatment measure.

[0039] The digital Zweckform 10 with the 3D body part model 20 is now provided to a data processing system 30, which has a computing unit 31 and a data storage unit 32. The computing unit and data storage unit can also be cloud-based solutions. The data storage unit 32 contains, among other things, basic models of possible orthoses. In the first step, the computing unit 31 in the exemplary embodiment of the Fig. 1 is now designed to perform an analysis based on the 3D body part model 20 of the digital Zweckform 10 in order to identify the correct basic model of a possible orthosis from the 3D body part model 20. Once a suitable basic model of an orthosis has been found, it is selected and used as the basis for the further process.

[0040] The computing unit 31 now automatically determines a digital volume model of the orthosis to be manufactured, more precisely the foot orthosis 100 to be manufactured, with knowledge of the selected base model, the 3D body part model 20 of the digital Zweckform 10, and other boundary conditions that will be explained in more detail later. After creating the digital volume model, which corresponds to the foot orthosis 100 to be manufactured, corresponding production data 40 is generated, which is then transmitted to an automated production system 50. In the simplest case, the production data 40 can be the created digital volume model, which is then analyzed by the automated production system 50 to control the system in order to generate the corresponding control signals for controlling the automated production system 50.However, it is also conceivable that the production data 40 already contain the control signals used to control the automated production system 50. Ultimately, this depends on the specific application and the type of automated production system 50 or the automated production process performed by the production system 50.

[0041] In the example of Fig. 1, the automated manufacturing system 50 is a 3D printing system with which the foot orthosis 100 can be automatically manufactured in an additive or generative manufacturing process based on the digital volume model and the manufacturing data 40.

[0042] The data processing system 30 is also configured to allow manual intervention by a technician 60, thus creating the possibility of manually manipulating the volume model and thus the foot orthosis to be manufactured. This allows for the consideration of special requests that cannot be produced automatically.

[0043] Fig. Figure 2 shows the 3D body part model 20 of a Zweckform 10, on the basis of which a foot orthosis is to be manufactured. The 3D body part model 20 is a digital computer model that approximates the shape and geometry of a scanned body part, in this case a foot, of a handicapped person. It is conceivable that this digital computer model 20 was generated based on a scan of the body part in question. However, it is also conceivable that the digital computer model 20 was generated based on a body part impression.

[0044] Based on the medical indication of the handicapped person, the 3D body part model was adapted so that the foot orthosis based on it contains the necessary treatment measure.

[0045] Fig. Figure 3 shows the special purpose mold 10, on which a plurality of markings 11 and 12 are provided. Based on these markings, which can be applied manually or automatically to the special purpose mold 10 in the digital computer model, the solid model is generated, as will be shown later.

[0046] The first type of markers 11 are anatomical features of the relevant body part, such as an ankle or ankle joint. Based on these anatomical features, which are applied to the digital Zweckform 10 in the form of markers 11, corresponding areas are later generated, each of which has a specific function.

[0047] The second type of markings 12 can be product-specific features where, for example, reinforcement areas, perforation areas, padding areas or bulge areas are later provided on the foot orthosis.

[0048] Both the recognition of the first type of markings 11 and the recognition of the second type of markings 12 can be performed automatically by the data processing system 30. The anatomical features for the first type of markings 11 can be recognized from an analysis of the underlying body part, which can be derived from the 3D body part model 20. The product-specific features for the second type of markings 12 can, for example, be predefined for each basic model.

[0049] Based on the markings 11 and / or 12, the edge boundary 13 of the foot orthosis to be produced is now automatically determined by the data processing system and placed on the 3D body part model of the Zweckform 10, as in Fig. 4. The edge boundary 13 represents an outer closure of the orthosis to be manufactured or of individual elements of the orthosis. The edge boundary 13 thus defines the outer closure of the orthosis and thus defines the basic geometry, shape, and dimensions of the orthopedic device to be manufactured.

[0050] Based on the edge boundary 13 defined in this way, a digital surface model 14 of the orthosis 100 to be manufactured is generated, which covers the 3D body part model 20 of the Zweckform 10 in the areas where the subsequent orthosis is to be attached to the body part. The digital surface model 14 represents the inside of the orthosis 100 to be manufactured and, in particular, is the side of the orthosis 100 that faces the body part of the disabled person to be treated.

[0051] As in Fig. 5, special areas 15 to 18 on the Zweckform 10 or the 3D body part model 20 are now preferably automatically defined, in which special, product-specific features 15 to 18 of the orthosis 100 must later be incorporated. These special, product-specific features 15 to 18 of the later orthosis 100 are automatically recognized by the data processing unit based on the selected basic shape of the orthosis to be manufactured, the edge boundary 13, and the defined markings 11 and 12.

[0052] From this, it can be deduced that area 15 is an ankle area where a perforation must be incorporated into the later-produced orthosis to avoid unpleasant pressure loads on the ankle area. Area 16 forms a cushioning area where a cushion will later be inserted. Area 17, which results from the shape of the 3D body part model and is identified as the heel, will later form a stiffening area where the orthosis requires a thicker wall thickness. Finally, area 18 forms a bulge area where the orthosis opens slightly, like a collar.

[0053] With the help of the data processing system 30, it is also possible, as in Fig. 6, the possibility of manually intervening in the shape, geometry, and dimensions of the orthosis to be manufactured. By selecting corresponding points on the edge boundary 13, these can be moved with respect to their position on the special-purpose mold 10, allowing the appearance, shape, form, geometry, and / or dimensions of the orthosis to be manually adjusted.

[0054] Based on the edge boundary 13 and the resulting digital surface model 14, a digital volume model 19 is now generated, taking into account a given average material thickness, as is the case for a foot orthosis in Fig. 7. The wall thickness can be adjusted depending on the previously defined areas (see Fig. 5) adapted or varied accordingly to take into account the product-specific properties or the boundary conditions imposed by the selected production facility. List of reference symbols 10 digital Zweckform 11 markings of anatomical features 12 markings of product-specific features 13 Edge boundary 14 digital surface model 15 Perforation area 16 Upholstery area 17 Stiffening area 18 Protrusion area 19 digital volume model 20 3D body part models 30 data processing system 31 computing unit 32 data storage 40 manufacturing data 50 automatic production lines 100 orthopedic device / orthosis

Claims

[1] Method for creating manufacturing data (40) for manufacturing an orthopaedic device (100) which can be manufactured using the created manufacturing data (40) in an automated manufacturing process, the method comprising the following steps: - providing a digital functional form (10) in a data processing system (30), wherein the digital functional form (10) contains a 3D body part model (20) of a body part for which the orthopaedic device (100) is intended, - automatically creating a digital volume model (19) of the orthopaedic device (100) to be manufactured based on the 3D body part model (20) of the provided digital Zweckform (10) by means of the data processing system (30), and - generating the digital production data (40) from the digital volume model (19) by means of the data processing system (30), characterized bythat the digital Zweckform (10) is provided in such a way that a plurality of markings (11, 12) are provided on the 3D body part model (20), wherein the edge boundary of the orthopaedic device (100) is generated manually or automatically by means of the data processing system (30) as a function of the markings (11, 12) provided on the 3D body part model (20), and / or wherein a plurality of anatomical features (11) are automatically recognized as markings based on the 3D body part model (20) of the provided digital Zweckform (10) and then the edge boundary of the orthopaedic device (100) is generated as a function of the recognized anatomical features. [2] Method according to claim 1, characterized bythat a digital surface model (14) of the orthopaedic device (100) to be manufactured is created by means of the data processing system (30) based on the 3D body part model (20) of the provided digital Zweckform (10) and an edge boundary (13) of the orthopaedic device (100) specified on the 3D body part model (20), wherein the surface model (14) forms the inside of the later orthopaedic device (100) and wherein the digital volume model (19) of the orthopaedic device (100) to be manufactured is created automatically by means of the data processing system (30) based on the digital surface model (14) and a specified material thickness of the orthopaedic device (100) to be manufactured. [3] Method according to one of the preceding claims, characterized bythat a digital surface model (14) and / or the digital volume model (19) is created by means of the data processing system (30) taking into account at least one predetermined cushioning area (16), area of ​​varying wall thickness, reinforcement area, perforation area (15), bulge area (18), joint area and / or an area which is provided for the integration of further components or semi-finished products. [4] Method according to claim 3, characterized by that the at least one padding area (16), area of ​​varying wall thickness, reinforcement area, perforation area (15), bulge area (18), joint area and / or an area for integrating further components or semi-finished products is manually specified on the 3D body part model (20). [5] Method according to claim 3 or 4, characterized bythat by means of the data processing system (30) the at least one padding area (16), area of ​​varying wall thickness, reinforcement area, perforation area (15), bulge area (18), joint area and / or an area for the integration of further components or semi-finished products is automatically specified as a function of one or more markings (11, 12) and / or is automatically specified as a function of anatomical features recognized by the data processing system (30) based on the 3D body part model (20). [6] Method according to one of the preceding claims, characterized by that a digital surface model (14) and / or the digital volume model (19) of the orthopaedic device (100) to be manufactured is automatically created with knowledge of a predetermined basic model. [7] Method according to claim 6, characterized bythat the predetermined basic model is automatically selected from a plurality of basic models by the data processing system (30) as a function of the 3D body part model (20). [8] Method according to one of the preceding claims, characterized by that a digital surface model (14) and / or the digital volume model (19) of the orthopaedic device (100) to be manufactured is automatically created with knowledge of a predetermined medical indication or desired support effect. [9] Method according to one of the preceding claims, characterized by that the orthopaedic device (100) is an orthosis, in particular a foot orthosis, hand orthosis, knee orthosis, torso orthosis or head orthosis, a prosthesis or an exoskeleton. [10] Method according to one of the preceding claims, characterized bythat the digital functional form (10) is provided by scanning the body part by means of a scanning device and then generating the 3D body part model (20) as a function thereof. [11] Computer program with program code means arranged to carry out the method according to one of claims 1 to 9, when the computer program is executed on a data processing system (30). [12] Method for manufacturing an orthopaedic device (100), the method comprising the following steps: - Creating manufacturing data (40) for the orthopaedic device (100) using the method according to one of claims 1 to 10, - feeding the production data (40) to an automated production system (50) which produces the orthopaedic device (100) using the created production data (40) in an automated production process. [13] Method according to claim 12, characterized by Manufacturing the orthopaedic device (100) by the automated manufacturing process using the automated manufacturing system (50) depending on the supplied manufacturing data (40).

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