METHOD FOR MANUFACTURING A PROSTHETIC SHAFT

Description

[0001] The invention relates to a method for manufacturing an orthopaedic product for a body part of a patient and a method for generating production data for an orthopaedic product.

[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.

[0005] A prosthetic socket for an amputation stump is typically made of a rigid material, such as fiber-reinforced plastic, and forms an important part of the interface between the amputation stump and the prosthesis attached to the socket. Such prosthetic sockets have long been used, particularly for leg prostheses intended for use on an amputation stump, such as 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, especially 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 primarily on the residual limb, 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.

[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] For example, US patent 2017 / 290685 A1 discloses a method in which the amputation stump is captured using a 3D scanner and the data thus obtained is displayed using a special display device. This allows the displayed 3-dimensional object to be freely rotated and viewed. A similar type of display is disclosed in WO 2019 / 157486 A1.

[0009] 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 volume so that the water exerts even pressure. Alternatively, a volume 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.

[0010] 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. Capturing data during the movement of the amputation stump is generally not possible. Furthermore, the scanning device usually has to be manually guided around the body part to be scanned, which is time-consuming and uncomfortable. In addition, it is generally not possible to deform the amputation stump, for example, by applying pressure, and then capture the deformed stump.

[0011] All the aforementioned methods, which are known from the prior art, have the disadvantage that only the external shape of the amputation stump is considered in the design of the prosthetic socket. The positioning of areas requiring special padding or pressure relief is only possible through the experience of the prosthetist. Particularly individual requirements or conditions resulting from specific characteristics of the amputation stump are difficult to incorporate. Scanning methods also have the disadvantage that the user, for example, an prosthetist, cannot directly modify and adjust the scan result on the stump. They therefore lose the conventionally available option of taking an impression of the stump and making adjustments.Although subsequent modification and adjustment of the scan is possible using an electronic data processing device, such as a computer, tablet or laptop, it does not offer the user the haptic feedback that occurs when pressing and molding the stump.

[0012] Another disadvantage is that, as already explained, the shaping of the amputation stump is based solely on static data, such as the external shape of the unweighted stump. Therefore, a test socket is first created, which must be tested and worn by the patient. This allows for verification of whether the socket meets the requirements or if 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.

[0013] Especially with prosthetic sockets, but also with other orthotic products such as orthoses, components or the entire product are ideally individually adapted to the patient's physical characteristics. In many cases, this requires precise measurements of the body part, which is associated with the problems described above.

[0014] 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 these disadvantages.

[0015] The invention solves the stated problem by a method for manufacturing an orthopaedic product for a body part of a patient, wherein the method comprises the following steps: a) Providing body part data containing information about the internal structure of the body part, b) Capturing the current viewing direction from which a user of the process sees the body part, c) Displaying the body part data from the current viewing direction using the display device, so that the user sees the body part and the body part data superimposed, d) Deforming and / or molding the body part, e) Capturing image data of the deformed and / or molded body part using a camera and / or a scanning device, at least also from the current viewing direction, which are displayed superimposed on the body part data using the display device, f) Generating production data for the orthopaedic product based on the displayed data and

[0016] Providing an orthopaedic product manufactured based on the production data.

[0017] The inventive method makes it possible to incorporate body part data, which includes information about the internal structure of the body part, into the production of the orthopaedic product.

[0018] A user of the method, for example, an orthotist performing the method according to the invention, can see information about the internal structure of the body part in the form of body part data on the display device, which can be, for example, a monitor, and simultaneously see the external contour and shape of the body part. This allows them to optimally adapt the shape of the orthotic product to the displayed information. This occurs during the generation of the production data, which preferably happens virtually. With the aid of an electronic data processing device, which preferably also controls the display of the data shown by the display device, an orthotic product can be created electronically that takes into account the displayed data and the patient's situation as depicted.

[0019] In preferred embodiments, which are described in more detail below, the step of generating production data includes further sub-steps, so that the production data is not simply created based on the body part data. Preferably, the user of the method, preferably the orthotist, can deform or mold the body part, for example, an amputation stump, so that modified body part data, rather than the originally provided body part data, forms the basis for the production data. Preferably, the user of the method releases the displayed data for the creation of production data.

[0020] The production data thus created and generated is then made available to a production facility that manufactures orthopedic products. This can be done, for example, by creating a negative or positive mold of an amputation stump based on the production data, which then serves as the basis for a prosthetic socket. For instance, a carbon fiber-reinforced prosthetic socket can be built onto a positive mold of the amputation stump by applying carbon fiber mats impregnated with a synthetic resin, which are then cured using a known process. Alternatively, the production data can also be provided to a 3D printer, which then prints the prosthetic socket in three dimensions using a suitable plastic material.In principle, all additive manufacturing methods are suitable for processing materials suitable for a prosthetic socket.

[0021] Alternatively, for example, splint systems, joints, shells, or other components of an orthosis can be manufactured that take into account the individual characteristics of the patient, such as 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 the subsequent use of the orthotic product.

[0022] It is important that the user of the procedure sees the body part data, which contains information about the internal structure of the body part, from the same viewing direction as, or at least almost the same viewing direction as, the body part itself. This allows, for example, the ends of bones, muscle pathways, and nerve tracts to be displayed and taken into account during the manufacture of the orthotic product and the generation of the production data for that product.

[0023] 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.

[0024] Preferably, the body part data is 3-dimensional body part data.

[0025] In a preferred embodiment of the method, the body part data is displayed by means of the display device while the user of the method looks directly at the body part. This is possible, for example, using suitable glasses (virtual reality (VR) glasses, augmented reality (AR) glasses) or another technical device. In the particularly preferred case, the display device is a semi-transparent AR headset. This means that optical data, in particular the body part data, can be displayed, and the user can simultaneously see the body part through the display device. Preferably, a detection device is arranged on the display device, which allows the current direction in which the user of the display device is looking to be detected.

[0026] Alternatively or additionally, the body part data can also be projected onto the body part itself. The display device is then a projector that projects the body part data, preferably along the current line of sight, onto the body part, for example, an amputation stump.

[0027] These designs have the advantage that users of the procedure, who have previously used prior art methods in which they directly pressed and molded the body part with their hands, do not have to adapt. They can continue to work directly on the body part and look at their hands and the body part. It is not necessary to use a separate display device, such as a monitor or screen.

[0028] Alternatively or additionally, image data of the body part is captured, for which a camera system, for example, is used. The current viewing direction then corresponds to the camera's viewing direction of the body part. The user of the system looks at the display device, for example, a monitor or screen, and sees the body part from the camera's perspective. To obtain the most realistic image possible, it is necessary to also display the body part data from the current viewing direction on the display device. Since this involves body part data, the electronic data processing device is able to calculate which data can be displayed and in what relation to each other.

[0029] Alternatively or additionally, image data can also be acquired using a scanning device. This could be, for example, 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 achieved, 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. Alternatively or additionally, scan gloves can also be used for existing body parts, such as arms, legs, feet, or joints.These devices have sensors that can, for example, measure and determine absolute positions, so that the geometric shape and outer contour of the body part can be captured and measured, for example by having the user of the procedure stroke the skin of the body part while wearing a scanning glove.

[0030] The sensors used in the scan glove or scan liner include, for example, fiber Bragg sensors, ultrasonic sensors, or magnetic sensors, which detect the external shape of the body part. This shape can also be updated if the user of the procedure, such as an orthotist, deforms the body part. For example, pressure sensors could be used to determine the contact pressure.

[0031] Image data captured using a scanning device is also referred to as contour data in the following.

[0032] If the camera system capturing the image data of the body part is a single camera, the viewing direction corresponds to the direction from which the camera captures the body part. This includes not only the direction from which the camera can receive electromagnetic radiation but also the orientation of the body part relative to the camera. The position and orientation of the body part relative to the camera are known, allowing both to be positioned within a single coordinate system. Therefore, the viewing direction from which the image data is displayed is also predetermined. If the camera system is not a single camera but a system with multiple cameras, enabling, for example, a 3D capture of the body part, the viewing direction can be chosen freely or at least almost freely.This may include controls that allow the user of the procedure to change their viewing direction as needed.

[0033] Preferably, a semi-transparent display device is used, which, in addition to body part data, also displays image data and / or contour data of the body part. This image data is then captured by the user of the method. Since the display device is semi-transparent, the user can also directly view the body part. It is therefore advantageous if the displayed image data contains additional information. This can preferably be achieved by capturing the image data, for example, in a frequency range that is not perceptible to the human eye. For instance, an infrared camera can be used to generate a thermal image of the body part, which allows conclusions to be drawn about the blood flow in different areas of the body part. Alternatively or additionally, data on blood flow can also be included in the body part data.

[0034] Preferably, to generate the production data, product data is first created based on the three-dimensional body part data and / or the captured image data and / or contour data, which then serves as the basis for the production data. The three-dimensional product data is preferably generated by the electronic data processing unit. Even if a semi-transparent display device is used that only shows the body part data, it is advantageous in this case to capture image data and / or contour data of the body part via a camera device, which is then transmitted to the data processing unit. In this way, the data processing unit can generate the three-dimensional product data based on the displayed three-dimensional body part data and any undisplayed image data and / or contour data of the body part.However, it is important that the image data is captured from the current viewing direction.

[0035] The user of the procedure can make changes to the product data. This can be done, for example, by molding or reshaping the body part, such as an amputation stump. Alternatively or additionally, the user, for example, an orthotist, can apply markings to the body part or mark areas, for example, with hand gestures, which can be captured by a camera and recognized and processed by an electronic data processing unit. This makes it possible, for example, to mark areas where padding will later be applied. Different materials to be used in the product to be manufactured can also be assigned to different areas in this way.

[0036] Preferably, the body part data, particularly the 3D body part data, were acquired using a medical imaging procedure and are stored, for example, in an electronic data storage device accessible to an 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.

[0037] Alternatively or additionally, simulated data calculated by a model can also be used as body part data, especially as 3-dimensional body part data. This data is not based on actual internal data of the current body part, but is instead simulated and estimated, for example, based on data collections of body parts from other patients.

[0038] Body part data, especially 3D body part data, can also be acquired using a vibrometry method. Such a method, used to determine the mechanical properties of a human body part, particularly an amputation stump, includes, for example, the following steps: a) the human body part is excited to a mechanical vibration, b) the vibration is detected by a detection device, c) the detected vibration is evaluated by at least one electronic data processing device that determines at least one mechanical property of the body part.

[0039] This method is based on the understanding that a range of mechanical properties, such as elasticity, strength, and other vibration characteristics, can be determined by exciting the body part under investigation into a mechanical vibration, which is then recorded and analyzed. Depending on the distribution of, for example, bone and soft tissue within a body part, such as an amputation stump, mechanical vibrations will occur in different forms.

[0040] The detection device is capable of recording mechanical vibration. This is achieved by detecting and determining measured values ​​that provide information about the vibration behavior of the human body part. These values ​​can include, for example, the amplitude, damping, and / or frequency of a vibration. It is advantageous to record the corresponding measured values ​​not only at one point on the body part, but preferably over a larger area, and particularly preferably over the entire body part.

[0041] To evaluate the recorded mechanical vibration and determine the mechanical properties of the respective body part, the electronic data processing device preferably includes a theoretical model, preferably a three-dimensional model of the body part, to establish a link between the recorded measurements and the desired properties. The model incorporates, for example, assumptions about the location, orientation, size, and / or length of bones, muscles, or other organs and soft tissues within the body part under investigation. The model is particularly preferably based on information derived, for example, from existing MRI data of the patient, geometric templates, or other information sources. This includes, for example, the indentor test.In particular, 3-dimensional stump data generated by other procedures and / or investigation methods and / or models and statistical evaluations can be used.

[0042] The recorded vibrations, in particular the detected measured values, are transmitted to at least one electronic data processing unit. This unit processes the data and determines, for example, vibration durations, natural modes, or damping, from which, for example, the moving masses and stiffness can then be calculated.

[0043] In a preferred embodiment, at least one body part is excited to mechanical vibration by an excitation device. Alternatively, the body itself can also be set into vibration by conscious or unconscious muscle contractions. However, reproducible excitation is achieved by an external excitation device that acts on the body part from the outside.

[0044] Preferably, the excitation device exerts at least one mechanical impulse, in particular a shock, and / or furthermore a mechanical oscillation, for example a vibration, on the body part. In particularly preferred embodiments, the excitation device is capable of varying the frequency and / or amplitude of a mechanical oscillation exerted on the body part, so that these parameters are adjustable and thus reproducible. The excitation device, which is configured to exert mechanical impulses, in particular shocks, on the body part, is product-wise configured to vary the time interval, the intensity, and / or the duration of the individual mechanical impulses, such that these parameters are adjustable and thus reproducible. The mechanical impulse can consist of a shock or other movement of a portion of the tissue of the body part.While a push is delivered perpendicular or at least nearly perpendicular to the skin of the body part, a movement almost parallel to the skin of the body part, occurring in a locked position, can also be used as a mechanical impulse. Combinations of movement directions are, of course, also possible.

[0045] In a preferred embodiment of the method, the human body part is successively subjected to different mechanical vibrations, preferably generated by different excitations from at least one excitation device. In this way, different eigenmodes, different vibrations, and different responses of the at least one body part to the different excitations can be generated and studied. Multiple different measurements can be obtained, thus enabling the use of a more detailed model. Particularly when detecting and investigating eigenmodes, which can be present, for example, in the form of standing vibration waves, especially when the excitation device sets the at least one body part into a continuous mechanical vibration, vibration nodes may also be present where the soft tissues of the respective body part do not move or move only minimally at that point.It is therefore advantageous to examine different vibrations of the human body part in order to also induce vibrations at the points that are arranged in vibration nodes during a first vibration, which can then be examined.

[0046] It is therefore advantageous for the excitation device to excite at least one body part at at least two different positions and / or at multiple times, i.e., multiple times. As already explained, using multiple excitation positions allows for the generation and observation of different vibrations. This improves and expands the database on which the mechanical properties of the body part are based, enabling the use of more detailed models. By repeatedly exciting the same vibration, for example, by exciting a body part identically at the same position multiple times in succession, multiple measurements of the same vibration are performed, thus improving the measurement result and data quality.

[0047] Preferably, the detection device includes at least one optical detector, in particular at least one camera. More preferably, the detection device has several optical detectors, in particular several cameras, so that the respective vibration is detected from different directions. In this way, it is possible, for example, to capture the entire amputation stump, i.e., in particular in three dimensions. The at least one optical detector, in particular the at least one camera, is directed at the body part to be examined, preferably the amputation stump, and detects the vibrations that occur. Using image recognition software, different vibration modes, frequencies, and / or amplitudes can be detected and read out from the images thus captured. These can be incorporated into the model so that the desired mechanical properties can be calculated.

[0048] Preferably, at least one body part is irradiated with detection radiation, the reflection of which from the body part is detected by the detection device. The detection radiation is preferably electromagnetic radiation, and more preferably laser radiation. The detection radiation is directed onto the body part to be observed and reflected there. Particularly in the case of monochromatic laser radiation, the wavelength changes due to the Doppler effect when reflected from a moving object. If the point on the body part where the laser radiation strikes is moving directly towards the optical detector at the moment of impact, the frequency of the laser radiation is increased. If the point is moving away from the optical detector, the frequency is decreased.In this way, an image of the amputation stump or at least one body part can be generated, with the frequency of the reflected laser radiation displayed as a function of the point of impact. This allows for the creation of a velocity map, i.e., a distribution of the respective velocity and thus the oscillation.

[0049] In a preferred embodiment, at least one body part is provided with a marking. Preferably, the shape, size, direction, and arrangement of the marking are stored in an electronic data storage device of at least one electronic data processing unit. It is therefore known what the marking looks like when at least one body part is not set into vibration. If the body part is set into vibration, at least the skin on which the marking is located moves, so that preferably the marking also moves. However, since the skin does not move homogeneously when the at least one body part is set into vibration, displacements, distortions, and deformations occur in the marking, which can be detected or evaluated.

[0050] Preferably, the at least one marking is applied to the body part, in particular by being glued, sprayed on, or applied in the form of a coating or inscription. The body part with the applied marking is then first measured, i.e., detected by the detection device, without being set into vibration. Alternatively or additionally, a marking can also be projected onto the body part by, for example, exposing it to strip-shaped illumination. This means that the body part is not illuminated across its entire surface, but rather with a pattern of light and dark areas, which can also be detected by the at least one detection device.Even if the marking, i.e., the illumination itself, does not change due to the vibrations, the position, orientation, and orientation of individual skin sections of at least one body part relative to the light source do change, causing the body part to move relative to the marking. This also leads to a change in the arrangement of the illuminated and unilluminated areas on the body part, which can be detected and analyzed.

[0051] The mechanical property detected by the methods described herein preferably includes the location and / or position of at least one internal tissue and / or organ region, a material composition, elasticity, and / or vibration damping. The human body part is particularly preferably an amputation stump.

[0052] Preferably, the 3-dimensional product data is displayed using the display device. Particularly preferably, it is superimposed on the body part data.

[0053] Preferably, the body part data, especially the 3-dimensional body part data, includes information about the bones, muscles, nerves, blood vessels and / or soft tissues of the body part. This concerns the position, orientation and course of the respective parts.

[0054] According to the invention, before the production data is generated, the body part is deformed and / or a mold is taken, and the correspondingly modified image data is then displayed using the display device. The deformation of the body part can be carried out, for example, manually by the orthotist. Experience gained with previous methods using plaster molding can thus also be applied to the new method. The orthotist shapes the body part as desired. If a camera is used, it captures the image data. This image data, modified according to the deformation of the body part, is displayed using the display device. In this way, even virtually represented and pre-constructed orthotic products can be adapted to the changed dimensions and shapes of the respective body part.

[0055] Preferably, an electronic data processing unit uses an underlying model to calculate the effects of deformation and / or molding of the body part on its internal structure. This includes, for example, the displacement or movement of bones and muscles, whose course and / or length can change due to the deformation and / or molding of the body part. Soft tissues can be compressed, altered in shape, or displaced by the deformation of the body part. In the preferred embodiment, all these changes resulting from the deformation of the body part are calculated by the electronic data processing unit. Based on the results of this calculation, the body part data is modified and displayed in this modified form on the display device.The modified body part data is then superimposed on the altered image data, allowing the orthotist to directly visualize the effect and result of the deformation and / or impression of the body part. They are no longer limited to experience and intuition but can verify whether the deformation and / or impression achieves the desired effect. If not, they can make corrections and perform a different deformation and / or impression. Preferably, modified 3D product data is also generated based on the modified body part data and / or the altered image data, and this data then forms the basis for the production data.

[0056] As already explained, the deformation and / or impression of the body part is captured using at least one scan glove and / or one scan liner.

[0057] Preferably, after generating the production data, a simulation is performed to determine the effects of stress and / or movement of the body part while the orthotic product is in place. The results of this simulation are then displayed. This verifies whether the production data results in an orthotic product that meets the requirements and ensures sufficient comfort while maintaining functionality. This is preferably done using an electronic data processing unit that employs a model to simulate the stresses and / or movements of the body part. The simulation identifies, for example, where particularly high pressures or friction occur under specific stresses and / or movements, potentially leading to pain and wounds, or at the very least, significantly reducing comfort.

[0058] The data calculated in this way provides insights into, for example, the stresses within a gait cycle. The user of the method, particularly an orthotist, is then able to make changes to the product and production data, adapting them to the dynamic conditions. Ideally, this eliminates the need to manufacture a test product, such as a test socket for load testing, and allows for direct production of the final product.

[0059] Additionally or alternatively, movements of the body part, particularly an amputation stump, can be recorded using the camera and / or scanning device. These movements can then be simulated so that the electronic data processing unit can calculate how these actual and feasible movements affect the body part data, especially if the orthotic product were manufactured and worn according to the existing production data. This includes loads and movements that are particularly important when the orthotic product affects a joint of the wearer.

[0060] Preferably, the viewing direction is adjustable. This is particularly advantageous if, for example, individual elements of the internal structure of the body part are only visible from different viewing angles. Alternatively or additionally, changing the viewing direction is beneficial to optimally adapt the prosthetic socket to the body part from virtually any direction. Furthermore, changes in the shape of the body part as seen from different viewing angles can cause different changes in the internal structure, thus necessitating different modifications to the body part data.

[0061] In a preferred embodiment of the method, the direction of gaze is calculated from the position and orientation of the body part relative to the camera device, in particular a camera. This can be done in various ways. For example, if the position and orientation of the at least one camera that the camera device has is known, this position and orientation can be used as the basis for the calculation. If, in addition, the position and orientation of, for example, a holder or a support in which the body part is held or on which it rests is also known, these two positions and orientations can be used to calculate the direction of gaze.

[0062] Preferably, the position and orientation of the body part relative to the camera device are calculated from the captured image data, wherein the body part preferably has at least one marking, in particular a sticker and / or a label. The camera device has at least one camera that captures the body part and records the image data. If the shape of the body part is known, image recognition software in the electronic data processing device can be used, for example, to calculate the orientation and position of the body part relative to the camera and its distance from it. This provides all the data necessary to determine the viewing direction. Alternatively or additionally, at least one marking can also be placed on the body part.If this occurs at predefined locations, it is possible to determine the position and orientation of the markings, for example, at least one sticker, from the recognized image data. This allows the position and orientation of the body part relative to the camera to be determined from the known position of the markings on the body part. This also allows the direction of gaze to be unambiguously determined.

[0063] The actual adaptation of the product to the body part preferably takes place up to the point of generating the production data. This data can then be transmitted to a conventional production facility, which is not necessarily the same location as where the previous process steps were carried out. For example, it is possible to transmit data electronically, particularly wirelessly, via networks such as the internet to the production facility, which can be located almost anywhere in the world.

[0064] The invention also solves the stated problem by a method for displaying body part data, in particular 3-dimensional body part data, which can be used in one of the methods described herein. The body part data is displayed in such a way that a user of the method sees both the body part data and the body part itself superimposed. The user sees both the body part and the body part data from their current viewing direction.

[0065] Using such a method, for example, an orthotist can adapt an existing orthosis to the individual characteristics and needs of the patient, adjusting, setting, or shifting joint axes, positions, and / or orientations. This method is also advantageous if changes made to the orthosis and / or the body part that affect its internal structure are recorded and processed by the electronic data processing unit. The electronic data processing unit is therefore preferably capable of modeling the impact of these changes, adjusting the body part data accordingly, and displaying the adjusted data.

[0066] The invention also solves the stated problem by means of a device for carrying out a method described herein, wherein the device comprises at least one camera device, at least one display device and at least one electronic data processing device.

[0067] In a particularly preferred embodiment, the camera and display devices are parts of a single device to be positioned on the user's head. This device may, for example, be a pair of glasses, in particular VR (Virtual Reality) glasses, AR (Augmented Reality) glasses, or a corresponding cap or helmet. With such a device, it is particularly easy for the user of the device, who wishes to perform the procedure, to view the amputation stump from different angles and to adjust the prosthetic socket accordingly.

[0068] With the aid of the accompanying drawings, some exemplary embodiments of the present invention are explained in more detail below. They show Figures 1 and 2 are schematic representations of process flows, and Figure 3 is a schematic representation of image data and 3-dimensional body part data.

[0069] Figure 1Figure 1 schematically shows a setup and process flow as it can be used for an embodiment of the present invention. An orthotic product is to be created for a schematically depicted body part 2, which is represented as an amputation stump. For this purpose, body part data 6 are first provided, for example, via medical procedures 4. A wide variety of medical procedures 4 can be used. Different medical procedures 4 are shown, each schematically represented. Of course, several or fewer medical procedures 4 can also be used to provide body part data 6.

[0070] Body part data 6 is provided to an electronic data processing device 8, which has a display module 10. The body part data 6 is transmitted to this display module. The body part 2 is also captured by a camera device 12. This sends image data 14 to the electronic data processing device 8 and, in particular, to the display module 10. The camera device 12 captures the body part 2 in the current viewing direction. The camera device 12 can be based on visible light, UV light, or infrared waves and capture corresponding images of the body part 2.

[0071] The display module 10 of the electronic data processing device 8 is configured to create a combined image from the body part data 6 and the image data 14 provided to it and to display these superimposed. For this purpose, the device has a display device 16, which is, for example, a monitor. The display module 10 detects or knows the current viewing direction and also displays the transmitted body part data 6 from the current viewing direction, so that a user of the process who is not currently displayed sees the body part data 6 and the image data 14 superimposed on the display device 16 from the same current viewing direction.

[0072] The body part data 6 and the image data 14 are also transmitted to a creation module 18 of the electronic data processing device 8. This module creates production data 20 based on the transmitted data, which is then transmitted to a production facility 22. This could be, for example, a 3D printer or other manufacturing equipment.

[0073] Figure 2Figure 1 shows a further embodiment that differs from the embodiment shown in Figure 1 only in one detail. The body part 2 is not observed by a camera device 12, but by the user 24 of the procedure, who is schematically represented as an eye. The user looks through the display device 16, which is, for example, AR glasses. The display device 16 is semi-transparent, so that the user 24 sees both the body part 2 and the data provided by the display module 10. This data consists exclusively of body part data, in particular 3-dimensional body part data 6, which were acquired and provided by the various medical procedures 4. Both in the process according to Figure 1 and Figure 2, the user 24 sees the body part 2 and the data provided by the display module 10. Figure 1 as well as in the process according to Figure 2The body part data 6 are of course not provided directly by the medical procedures 4. Rather, they are generated by the medical procedures 4 and stored in an electronic data storage device, which is not shown, and which the electronic data processing device 8 can access.

[0074] Figure 3 This schematically shows the different data that are superimposed. In the upper left area of ​​the Figure 3 Image data 14 of an amputation stump, i.e., a body part 2, are shown. In the upper right area, the bones 26 located inside body part 2 are shown. This data was generated, for example, by an MRI procedure and is stored in an electronic data storage device. It is therefore 3-dimensional body part data 6. In the lower area of ​​the Figure 3The image data 14 and the 3-dimensional body part data 6 are superimposed, as is the case, for example, on the display device 16 in the Figure 1 The arrangement shown would be the case. Reference symbol list

[0075] 2 Body part 4 Medical procedure 6 Body part data 8 Electronic data processing device 10 Display module 12 Camera device 14 Image data 16 Display device 18 Creation module 20 Production data 22 Production site 24 User 26 Bone

Claims

1. A method for producing an orthopedic product for a body part of a patient, the method comprising the following steps: a) providing body part data that contains information about the inner structure of the body part, b) detecting a current direction of view from which a user of the method sees the body part, c) presenting the body part data from the current direction of view by means of the display device, so that the user sees the body part and the body part data superimposed, d) deforming and / or molding the body part, e) capturing image data of the deformed and / or molded body part by means of a camera and / or a scan device at least also from the current direction of view, said image data being displayed superimposed on the body part data by means of the display device, f) generating production data for the orthopedic product on the basis of the data displayed, and g) providing an orthopedic product produced on the basis of the production data.

2. The method according to claim 1, characterized in that the body part data is three-dimensional body part data.

3. The method according to claim 1 or 2, characterized in that the display device is partially transparent, so that the user can look through the display device.

4. The method according to one of the preceding claims, characterized in that, in order to generate the production data three-dimensional product data is initially generated on the basis of the body part data and / or the captured image data, on the basis of which the production data is generated.

5. The method according to one of the preceding claims, characterized in that the body part data has been obtained by a medical imaging process or is obtained as part of the method prior to its provision.

6. The method according to claim 4 or 5, characterized in that the three-dimensional product data is displayed using the display device, wherein it is preferably shown superimposed on the body part data.

7. The method according to one of the preceding claims, characterized in that the body part data contains information on bones, muscles, nerves, blood vessels and / or soft tissues of the body part.

8. The method according to one of the preceding claims, characterized in that prior to generating the production data, the body part is preferably deformed and / or molded and an electronic data processing device uses a model to calculate the effects of the deformation and / or molding of the body part on the internal structure of the body part and modifies the body part data accordingly, wherein the modified body part data is then displayed.

9. The method according to claim 8, characterized in that three-dimensional product data adapted to the deformation and / or molding is generated in order to generate the production data.

10. The method according to claim 8 or 9, characterized in that the deformation and / or molding of the body part is captured by means of at least one scanning glove and / or scan liner.

11. The method according to one of the preceding claims, characterized in that, after generating the production data, the effects of a load and / or a movement of the body part when the orthopedic product is in the mounted state on the body part are simulated and the result of this simulation is displayed by means of the display device.

12. The method according to one of the preceding claims, characterized in that the direction of view can be changed.

13. The method according to one of the preceding claims, characterized in that direction of view is calculated from a position and orientation of the body part relative to the camera device, in particular a camera.

14. The method according to claim 13, characterized in that the position and orientation of the body part relative to the camera device is calculated from the captured image data, the body part preferably featuring at least one marker, particularly a sticker and / or label.

15. A method for generating production data for an orthopedic product, wherein the method comprises the following steps: a) providing body part data that contains information about the inner structure of the body part, b) detecting a current direction of view from which a user of the method sees the body part, c) presenting the body part data from the current direction of view by means of the display device, so that the user sees the body part and the body part data superimposed, d) deforming and / or molding the body part, e) capturing image data of the deformed and / or molded body part by means of a camera and / or a scan device at least also from the current direction of view, said image data being displayed superimposed on the body part data by means of the display device, f) generating production data for the orthopedic product on the basis of the data displayed.

16. A device for conducting a method according to one of the preceding claims, the device comprising at least one camera device, at least one display device and at least one electronic data processing device.

17. The method according to claim 16, characterized in that the camera device and the display device form part of a device to be arranged on the head of a user, especially glasses / goggles, a hood or a helmet.