METHOD FOR PRODUCING A CONNECTOR

Description

[0001] The invention relates to a method for producing a connecting element for connecting two components of an orthopedic device for a body part. The invention also relates to a method for producing the orthopedic device.

[0002] Orthopaedic devices have long been known from the state of the art and include, for example, orthoses that can protect, support or, for example, restrict the movement of an existing body part of the wearer, prostheses that replace a body part of the wearer and exoskeletons to support body parts.

[0003] An orthosis for a body part is generally attached to that body part. For example, a knee orthosis is attached to the wearer's knee, and an elbow orthosis is attached to the wearer's elbow. Within the meaning of the present application, such an orthosis is designed for the respective body part. A prosthesis, on the other hand, is attached to an existing body part of the wearer. A knee orthosis can, for example, be attached to a femoral stump by means of a prosthetic socket. Within the meaning of the present invention, such a knee prosthesis is an orthopedic device for the femoral part. Within the meaning of the present invention, an orthopedic device is an orthopedic device for a body part if it is attached to that body part or supports, protects, braces, or spans that body part.Although a knee brace is typically placed on the thigh and lower leg, it spans and supports the knee. It can therefore be considered and described as an orthopedic device for the knee as well as for the thigh and lower leg.

[0004] An orthopedic device usually consists of more than two components that must be connected to each other. Connecting elements are used for this purpose. These can rigidly connect two components so that, when connected, no movement of the two components relative to each other is possible. This is the case, for example, with a socket adapter, which is attached to a prosthetic socket and connects it to another prosthetic element, such as a prosthetic knee or a tubular element. The orientation of the two components relative to each other can be adjusted if necessary; however, when connected, relative movement is undesirable and therefore impossible.

[0005] A connecting element can also be designed such that the two components are movable relative to each other when connected. This is the case, for example, if the connecting element has a joint or is designed as a joint. Such a joint connects, for example, a thigh element and a lower leg element of a knee orthosis or a lower leg element and a foot element of an ankle orthosis.

[0006] WO 2018 / 148039 A1 and US Pat. No. 10,779,982 B2 each disclose methods in which individual components of an orthopedic device are manufactured based on scan data of a body part, thus resulting in a particularly well-adapted and customized fit to that body part. Connecting these components using a separate connecting element is not described.

[0007] Particularly in the case where the connecting element connects components of which at least one, but preferably both, was manufactured individually for the wearer of the orthopedic device, for example as a carbon fiber composite component, the connecting element is often adapted to the individual needs and circumstances. For example, a joint leg of such a connecting element is designed as a metal component that forms a flat surface and has a length that allows a sufficient connection to one of the components to be connected. This joint leg is deformed during manufacture of the orthopedic device in order to bring it into the desired shape. This is usually done by the orthopedic technician who manufactures the orthopedic device. In the simplest case, the metal joint leg is bent while cold.Although this achieves the desired shape, it places a high mechanical load on the material, reducing its stability.

[0008] To compensate for this, the connecting element is usually initially manufactured with a greater material thickness than is actually necessary for the loads encountered. This increases the material requirements and thus the cost and weight of the connecting element, and also complicates the forming process by the orthopedic technician.

[0009] The invention is therefore based on the object of further developing a method for producing a connecting element and an orthopaedic device in such a way that the disadvantages of the prior art are eliminated or at least mitigated.

[0010] The invention solves the problem by a method for producing a connecting element for connecting two components of an orthopaedic device for a body part, which method comprises the following steps: Acquiring 3-dimensional scan data of at least part of the body part using a scanner, determining a target position and / or a target orientation of the connecting element relative to the body part from the scan data, modeling the connecting element using the scan data, the target position and / or the target orientation and information about the components to be connected and manufacturing the modeled connecting element.

[0011] The method according to the invention produces a connecting element that preferably no longer requires reshaping by the orthopedic technician. This allows the material thickness to be reduced to the necessary minimum, thereby lowering material usage and thus manufacturing costs. Furthermore, the manufacturing time for the orthopedic device is shortened because the orthopedic technician has to perform fewer process steps.

[0012] First, at least part of the body part, but preferably the entire body part, is scanned using a scanner, whereby the 3-dimensional scan data is recorded. This is in the form of electronic data, which can be stored, for example, in a data memory of an electronic data processing device. The scanner is preferably a mobile device, such as a handheld scanner. Such a handheld scanner can preferably be operated with one hand and is aimed at the body part by a person performing the method in such a way that the scan data is recorded. The body part is preferably irradiated with suitable scanning radiation, which is then detected by a suitable detector. The scanning radiation is, for example, a light pattern of visible light and / or infrared radiation, and the detector is a camera designed for the wavelength used.The scan data is preferably captured using a photogrammetric method. In other words, photogrammetry is used to capture the scan data.

[0013] Alternatively or additionally, at least one stationary scanner can be used. In this case, too, the body part to be scanned is preferably irradiated with suitable scanning radiation. A plurality of detectors, such as suitable cameras, are arranged around the body part, which capture and image the body part from different spatial directions. The scan data is determined from the individual images acquired in this way using image processing. The processes and methods for acquiring the scan data are very similar or even identical to those used with a mobile scanner.However, with a stationary scanner, it is possible to acquire multiple individual images with multiple detectors, particularly cameras, simultaneously or at short intervals. While using a mobile scanner, it takes a longer time to acquire the necessary data from the different angles and perspectives. Since the body part should preferably not be moved during the acquisition of the scan data, using a stationary scanner is advantageous. However, this increases the equipment required.

[0014] After the scan data has been acquired, the target position and / or orientation of the connecting element relative to the body part is determined. The connecting element is then modeled, taking the determined target position and / or orientation into account. This creates a geometric configuration for the connecting element that eliminates the need for further reshaping at a later date. In particular, the space available for the connecting element is taken into account, which results from the scan data—i.e., the underlying physical conditions—and the components to be connected.

[0015] Preferably, a so-called functional form is first created from the scan data. For this purpose, the scan data is modified in such a way that an orthopedic device adapted to this modified scan data fulfills its purpose on the actual body part well and as optimally as possible. This is preferably done automatically by means of an electronic control system, for example software running within an electronic data processing device that is configured to modify the scan data and thus create the functional form. In this case, the target position and / or target orientation is then determined based on the created functional form. When creating the functional form, for example, the volume of a body part is changed, preferably enlarged, or the position and / or orientation of one body part is adjusted to another body part.For example, the position of the foot relative to the lower leg can be adjusted and changed compared to the actual position depicted by the scan data.

[0016] In a preferred embodiment of the method, at least one marking recognizable by the scanner is applied to the body part before the scan data is acquired. The marking is preferably glued to the body part or applied to the body part with a color that can be detected by the scanner. It is important that the marking is also included in the scan data and is recognizable.

[0017] The at least one marking preferably marks locations on the body part that are important for positioning the connecting element and / or one or both components to be connected by the connecting element. These locations preferably mark the course and / or position of joint axes of the body part, particularly sensitive areas such as sensitive soft tissue, scar tissue, or areas where a bone or bone end is only covered by a thin layer of tissue. If several different locations on the body part are each provided with a marking, different markings are preferably used. This preferably makes it possible to identify the individual marked locations from the type of marking in the scan data.

[0018] Preferably, one of the components to be connected and / or the connecting element has a joint. The target position and / or the target orientation is preferably determined such that a joint axis of the joint coincides with a joint axis of the body part. This is particularly easy to achieve if the joint axis of the body part has been marked on the body part, and this marking is recognizable in the scan data.

[0019] In a preferred embodiment, the scan data is acquired in two different positions and / or loads on the body part. This is particularly advantageous when the orthopedic device is intended to apply a force to the body part that leads to a deformation of the body part. Preferably, the orthopedic device is applied to the body part without any force being initially applied. For this situation, the scan data acquired when the body part is not under load is preferably used. Only after application will the orthopedic device apply the desired force and cause the deformation of the body part. For this purpose, the orthopedic device can be adjusted, for example, by tightening a strap or adjusting a joint.Alternatively or additionally, the deformation occurs due to stress on the body part and the associated orthopedic device. This is particularly relevant for orthopedic devices in the form of prosthetic sockets, especially for the lower extremities.

[0020] When modeling the connecting element, a simulation of the expected load is preferably carried out, the results of which are incorporated into the modeling of the connecting element. Preferably, movements of the body part to which the orthopedic device is attached are simulated, and the resulting forces are determined. The connecting element is then modeled to withstand the determined forces. This optimizes the geometric shape and material thickness of the connecting element without compromising its operational reliability. In particular, material tapers and / or openings are integrated into the model of the connecting element at those locations where the simulation of the expected loads indicates a low load that allows this.

[0021] When modeling the connecting element, a target position and / or target orientation relative to at least one of the two components, preferably relative to both components, is preferably also determined. For this purpose, a position and / or orientation of the connecting element can be varied, with the expected loads and forces preferably being determined for each new position.

[0022] The connecting element is preferably produced using an additive manufacturing process, in particular a 3D printing process. A metal and / or a plastic, in particular a thermoset or polymer, is preferably used as the printing material. Fibers are particularly preferably incorporated into the printing material as stabilizing elements. These can be textile fibers, natural fibers, synthetic fibers, glass fibers, carbon fibers, or metal fibers. A fiber is understood in particular to be an almost one-dimensional element that consequently has a significantly greater extent in a first direction, referred to as the longitudinal direction, than in the plane perpendicular to this longitudinal direction.

[0023] Preferably, the fibers are introduced into the printing material in a controlled manner during the additive manufacturing process. This means that the quantity and direction of the longitudinal extension of the fibers are preferably predetermined during the modeling of the connecting element. Particularly preferably, the length of the fibers to be introduced is also predetermined.

[0024] During the modeling of the fastener, the quantity, length, material, and / or longitudinal direction of the fibers to be inserted are taken into account. This makes it possible to influence the stability of the fastener in predetermined areas and directions, thus further reducing the amount of material required.

[0025] The invention also achieves the stated object by a method for producing an orthopaedic device with at least two components which are connected at least by at least one connecting element, the method comprising the following steps: Manufacture the connecting element according to one of the methods described here and connect the two components using the manufactured connecting element.

[0026] In a preferred embodiment, the connecting element forms a joint with one of the components to be connected, by means of which the two components can be moved, preferably pivoted, relative to one another when connected. For this purpose, it is advantageous, for example, if the connecting element and one of the components each have a bore. These bores are brought into alignment during assembly of the orthopedic device. An axial element, for example a screw, pin, rod or bolt, is then guided through the two bores and fastened therein, such that the connecting element can be pivoted about this axial element relative to the component. If the connecting element is arranged rigidly, in particular in a rotationally fixed manner, on the other of the two components, the two components connected by the connecting element can be pivoted relative to one another.The connecting element preferably has at least one fastening rail, particularly preferably two fastening rails, which are arranged on the two joint parts of the joint, which are movable relative to each other. Particularly preferably, the at least one fastening rail is formed integrally with the respective joint part.

[0027] Preferably, the two components each have at least one section that is directly connected to one another, preferably in an articulated manner, particularly preferably by means of a follower joint. In this way, for example, a follower joint is produced. In an orthopedic device in which the connecting element is arranged on one side of the body part, for example laterally, the two sections are preferably arranged on the opposite side, for example medially. Preferably, the sections are arranged such that, when connected, they reduce torsional forces, relieve the connecting element, and / or improve the stability of the orthopedic device and / or its attachment to the body part.

[0028] Particularly preferably, a fastening section of at least one of the two components is modeled after modeling the connecting element or during modeling of the connecting element using the scan data, the target position and / or the target orientation, and information about the respective component. Particularly preferably, one of the two components, particularly preferably both components, is modeled after modeling the connecting element or during modeling of the connecting element using the scan data, the target position and / or the target orientation, and information about the respective component.

[0029] In a preferred embodiment of the method, at least one of the two components of the orthopedic device to be manufactured is a fiber composite component. Particularly preferably, both components to be connected are fiber composite components. These can be carbon fiber composite components or glass fiber composite components or other composite components. In this case, it is advantageous if the connecting element is connected to the at least one component designed as a composite component, but preferably to both components designed as composite components, and is thereby integrated into the layer structure of the respective component. Fiber composite components are produced from so-called prepregs, which are generally fabric elements, for example fiber mats made of the respective fiber material. These are inserted into the desired shape and generally coated with a synthetic resin which, upon curing, produces the fiber composite material.Often the individual fiber mats are already impregnated or coated with the synthetic resin.

[0030] In this state of the components, the connecting element is also arranged in the mold, in particular between different layers of the fiber mats of the composite material.

[0031] Some embodiments of the present invention are explained in more detail below with the aid of the accompanying drawings. They show: Figure 1-an ankle orthosis in a rear view, Figure 2-the ankle orthosis from Figure 1 in a side view, Figure 3-another ankle orthosis in a side view, Figure 4-the ankle orthosis from Figure 3 in a rear view Figure 5 - another ankle orthosis in a rear view and Figure 6a - 6eschematic representations of various process steps.

[0032] Figure 1shows an orthopedic device 2 in the form of an ankle orthosis. It has a first component 4 and a second component 6. In the present exemplary embodiment, the first component 4 is arranged on a user's lower leg (not shown) and the second component 6 is arranged on a user's foot (not shown). The first component 4 and the second component 6 are connected to one another by two connecting elements 8, each of which, in the exemplary embodiment shown, has a joint 10 with two joint parts 12 that can be pivoted relative to one another.

[0033] The joint parts 12 are each connected to a fastening rail 14 or are formed integrally with such a fastening rail 14. The connecting elements 8 are individually adapted to the shape and orientation of the ankle, foot, and / or lower leg of the user of the orthopedic device 2. For this purpose, the fastening rails 14 are individually designed in the illustrated embodiment. Differently designed fastening rails can be seen laterally and medially, which take into account the different geometries and different expected loads.

[0034] Figure 2 shows the orthopaedic device 2 from Figure 1 in a side view. The first component 4 and the second component 6 are connected to each other via the connecting element 8 with joint 10 and the two joint parts 12. At the proximal, i.e. Figure 2upper joint part 12 the fastening rail 14 is screwed onto, the fastening rail 14 is arranged in one piece on the distal joint part 12.

[0035] Figure 3 shows a side view of another orthopedic device 2. The first component 4 and the second component 6 each have a section 16 that are directly connected to each other and a follower joint 18.

[0036] Figure 4 shows the orthopaedic device 2 from Figure 3 in the rear view. The first component 4 and the second component 2 are, as already shown in Figure 3 shown, are directly connected to one another by the follower joint 18 on one side, in this case medially, while on the opposite side, in this case laterally, a connecting element 8 is arranged. This corresponds to the connecting element 8 from Figure 1. It has the joint 10 with the two joint parts 12 on which the respective fastening rails 14 are arranged.

[0037] Figure 5 shows an orthopaedic device 2, which corresponds to the Figure 4 They differ in the design of the sections 16 at which the two components 4, 6 are directly connected to each other and form the idler joint 18.

[0038] In the Figures 6a to 6e various process steps are shown. Figure 6aschematically shows a foot 20 being measured and scanned with a scanner 22. Three-dimensional scan data is acquired from the foot 20, which in this case represents the body part to be scanned. A marker 24 is applied to the foot 20, representing the position of a pivot axis, in this case an ankle axis. The marker 24 is selected so that it can be detected by the scanner 22 and is thus part of the three-dimensional scan data.

[0039] In Figure 6bA monitor 26 is shown. This illustrates that this and the method steps in the following two figures are carried out by means of an electronic data processing device, in particular a computer. The left part of the monitor 26 shows the 3-dimensional scan data 28, which in the exemplary embodiment shown show the foot 20 in exactly the position in which it was detected by the scanner 22. In this method step, a target position of the foot 20 is created, in which the foot is to be held by the orthopedic device 2 to be produced, which in the exemplary embodiment shown can be a foot raiser orthosis. It can be seen that the forefoot region is raised.

[0040] In Figure 6cIt is shown that a connecting element is schematically adapted to the thus modulated target data. In doing so, a target position and / or a target orientation of the connecting element 8 relative to the 20 is determined. This is represented by the dashed box 30 and the axis coordinate system 32 shown therein. This method step essentially involves determining the position and orientation. Individual designs of the individual elements or components of the connecting element 8 are not yet determined in this step.

[0041] This happens in Figure 6dThe connecting element 8 is modeled according to the target data of the foot 20. In the illustrated embodiment, it has three downwardly projecting arms 34, which form fastening sections and to which the connecting element 8 is later connected to the second component 6, in this case a foot part. The connecting element 8 also has a fastening device 36, which also forms a fastening section and with which it can be fastened to a first component 4, in this case to a lower leg splint, in the illustrated embodiment.

[0042] In Figure 6e It is schematically shown how the connecting element 8 is manufactured according to the data modulated in this way. In the illustrated embodiment, a 3D printer 38 with at least one print head 40 is used for this purpose. List of reference symbols

[0043] 2 orthopedic device 4 first component 6 second component 8 connecting element 10 joint 12 joint part 14 mounting rail 16 section 18 follower joint 20 foot 22 scanner 24 marking 26 monitor 28 scan data 30 dashed box 32 axis cross 34 arm 36 mounting device 38 3-D printer 40 print head

Claims

1. A method for producing a connecting element (8) for connecting two components (4, 6) of an orthopaedic device (2) for a body part, the method comprising the following steps: • capturing 3-dimensional scan data (28) of at least one part of the body part by means of a scanner (22), • determining a target position and / or a target orientation of the connecting element (8) relative to the body part from the scan data (28), • modelling the connecting element (8) using the scan data (28), the target position and / or the target orientation and information on the components (4, 6) to be connected, and • manufacturing the modelled connecting element (8).

2. The method according to claim 1, characterised in that, prior to capturing the scan data (28), at least one marker (24) that can be recognised by the scanner (22) is applied to the body part.

3. The method according to claim 1 or 2, characterised in that at least one of the components (4, 6) to be connected and / or the connecting element (8) has a joint (10).

4. The method according to one of the preceding claims, characterised in that the scan data (28) is captured in at least two different positions and / or loads of the body part.

5. The method according to one of the preceding claims, characterised in that, during modelling of the connecting element (8), a simulation of the anticipated load is performed, the result of which is included in the modelling of the connecting element (8).

6. The method according to one of the preceding claims, characterised in that the modelled connecting element (8) is produced by means of an additive manufacturing process, especially a 3D printing process.

7. A method for producing an orthopaedic device (2) with at least two components (4, 6), which are at least also connected by a connecting element (8), the method comprising the following steps: • producing the connecting element (8) according to one of the preceding claims and • connecting the two components (4, 6) by means of the connecting element (8) produced.

8. The method according to claim 7, characterised in that the two components (4, 6) each comprise at least one section (16) which are arranged directly, preferably in an articulated manner, particularly preferably by means of a support joint (18).

9. The method according to claim 7 or 8, characterised in that a fastening section (34, 36) of at least one of the two components (4, 6) is modelled after modelling of the connecting element (8) or during modelling of the connecting element (8) by means of the scan data (28), the target position and / or the target orientation and information on the respective component (4, 6).

10. The method according to one of the claims 7 to 9, characterised in that at least one of the two components (4, 6) is a fibre-composite component and the connecting element (8) is integrated into a layer structure of the component (4, 6) when being connected to this at least one component (4, 6).