Method and set for producing an orthosis

The method of detachable clamping and adjustment of orthosis fitting parts addresses the challenge of aligning pivot axes with natural joints, enhancing comfort and reducing complexity and cost in orthotic manufacturing.

WO2026062232A1PCT designated stage Publication Date: 2026-03-26OTTOBOCK SE & CO KGAA
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Patent Information

Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Filing Date
2025-09-19
Publication Date
2026-03-26

AI Technical Summary

Technical Problem

Aligning the pivot axis of orthotic joints with the natural joint axis is challenging, especially for complex joints like the knee, leading to friction and discomfort due to misalignment, and existing solutions are complex and expensive.

Method used

A method involving detachable clamping and adjustment of fitting parts on orthosis shells to align the pivot axis with the natural joint axis, using adjustable clamping devices and multiple fitting parts to ensure precise alignment before securing the joint components.

Benefits of technology

Facilitates simple and accurate alignment of orthosis joints, reducing friction and discomfort by ensuring the pivot axis coincides with the natural joint axis, thereby improving user comfort and reducing manufacturing complexity and cost.

✦ Generated by Eureka AI based on patent content.

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Abstract

The invention relates to a method for producing an orthosis, which comprises - a first shell (2) for arranging on a first body part (4) of a wearer comprising a first attachment region (10) and a first clamping device, - a second shell (6) for arranging on a second body part (8) of the wearer comprising a second attachment region (12), - and a joint (40) comprising a first mating part (30) and a second mating part (20), which are arranged on one another so as to be pivotable about a pivot axis, wherein the method comprises the following steps: a. arranging the first shell (2) on the first body part (4); b. arranging the second shell (6) on the second body part (8); c. releasably clamping the first mating part (30) in a first orientation and a first position on the first attachment region (10) by means of the first clamping device; d. providing the second mating part (20) in a second orientation and a second position on the second attachment region (12); e. checking whether the pivot axis is in a target position; f. loosening the first mating part (30) and / or second mating part (20) and changing the first orientation and / or the first position and / or the second orientation and / or the second position, if the pivot axis is not in the target position and checking again, g. fastening the first mating part (30) to the first attachment region (10) in the first position and the first orientation and providing the second mating part (20) on the second attachment region (12) in the second position and the second orientation, if the pivot axis is in the target position.
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Description

[0001] <• G in treal kmct uma ipr Lo pienr tsy

[0002] Ottobock SE & Co. KGaA Lawyer's File:

[0003] Max-Näder-Straße 15 0108-2062 PCT-1

[0004] 37115 Duderstadt Germany Date:

[0005] September 19, 2025

[0006] Procedure and set for manufacturing an orthosis

[0007] The invention relates to a method and a set for manufacturing an orthosis.

[0008] Orthoses are orthotic devices used to protect, support, or restrict the movement of a body part or one or more joints of the wearer, for example, when this is therapeutically appropriate and necessary after surgery or injury. Many orthoses span one or more joints of the wearer and must therefore be positioned on body parts on both sides of the joint. A knee orthosis, for example, has a thigh shell for placement on the thigh and a lower leg shell for placement on the lower leg. Both shells are connected by a joint that has a first fitting component and a second fitting component. The first fitting component is connected to one of the two shells, for example, the thigh shell. The second fitting component is connected to, or is connected to, the other of the two shells, in this case, the lower leg shell.The two fitting parts are connected to each other by a hinge and can be pivoted relative to each other around a pivot axis.

[0009] Several different joints are known in the art that can be used in such an orthosis. These are known, for example, as locking joints, which in a first state allow free movement of the two fitting parts relative to each other and in a second state completely prevent movement. The range of motion in the first state can be limited by one or two stops. Other joints that can be used in orthoses of the type described here allow restricted movement of the two fitting parts and thus also of the shells connected to them relative to each other, wherein preferably at least one of the stops restricting the range of motion can be adjustable.

[0010] An orthosis of the type described here can also be designed as an elbow orthosis, hand orthosis, ankle orthosis, hip orthosis, or other orthosis that spans a joint of the wearer. It therefore has a first shell for positioning on one body part and a second shell for positioning on a second body part of the wearer, with the first and second body parts located on opposite sides of the joint. The two shells are connected by a joint with a first fitting piece and a second fitting piece, the first fitting piece being attached to the first shell and the second fitting piece to the second shell.

[0011] One of the difficulties with such orthoses lies in aligning the pivot axis of the joint as closely as possible with the joint axis of the natural joint spanned by the orthosis. Ideally, though not always achievable, the pivot axis is congruent with the joint axis. In this case, movement of the wearer's natural joint results in movement of the orthosis joint itself, with the two components pivoting relative to each other around the joint's pivot axis. The two shells attached to the wearer's body parts remain stationary relative to those body parts. Conversely, an incongruity between the pivot axis of the orthosis joint and the joint axis of the natural joint leads to movement of the shells relative to the respective body parts to which they are attached.These movements cause friction and should therefore be avoided, as they are at least unpleasant and can lead to pain.

[0012] Fitting such an orthosis is therefore difficult, as the joint axis of the natural joint is often not identifiable or at least not precisely known. This is particularly true for knee orthoses, where the issue is further complicated by the fact that the knee does not have a simple pivot axis; rather, the pivot axis itself moves when the knee is bent. This movement can be accommodated by special joints in the orthosis. However, these special joints are complex and therefore expensive, meaning they cannot be used for every orthosis.

[0013] The invention is therefore based on the objective of proposing a method and a set with which an orthosis of the type described here can be manufactured simply and safely.

[0014] The invention solves the stated problem by a method for manufacturing an orthosis comprising a first shell for placement on a first body part of a wearer, with a first attachment area and a first clamping device, a second shell for placement on a second body part of the wearer, with a second attachment area, and a joint with a first fitting part and a second fitting part, which are pivotably arranged relative to one another about a pivot axis. The method comprises the following steps: a. Placing the first shell on the first body part, b. Placing the second shell on the second body part, c. Detachably clamping the first fitting part in a first orientation and a first position on the first attachment area by means of the first clamping device, d. Providing the second fitting part in a second orientation and a second position on the second attachment area, e.Check if the pivot axis is in a target position, f. Loosen the first fitting part and / or the second fitting part and change the first orientation and / or the first position and / or the second orientation and / or the second position if the pivot axis is not in the target position, and check again, g. Attach the first fitting part to the first connection area in the first position and the first orientation and provide the second fitting part to the second connection area in the second position and the second orientation if the pivot axis is in the target position.

[0015] In a method according to the invention, at least the first fitting part is therefore initially detachably attached to the first shell by clamping. The shells have been previously positioned on the respective body parts. Preferably, the shells are individually manufactured and adapted to the respective body part of the wearer of the subsequent orthosis, so that in particularly preferred embodiments they can be positioned on the body parts in exactly one orientation and exactly one position. However, less customized shells, which are adapted, for example, to the general shape of the respective body part, can also be used.

[0016] The second fitting part is provided on the second shell in the second orientation and position. In a preferred embodiment, the second shell has fastening points in the second connection area, for example, bores equipped with an internal thread for an insert, such as a sleeve, which is also equipped with an internal thread. The second fitting part can be attached to these fastening points, for example, by screwing it on. Preferably, several second fitting parts are available, from which the appropriate fitting part is selected. The various fitting parts are preferably designed such that they can all be attached to the fastening points of the second shell. This is preferably done in a detachable manner. The various second fitting parts make it possible, for example, to compensate for an angle between the first body part and the second body part.

[0017] If the orthosis to be manufactured is a knee orthosis, different secondary components may be available to compensate for varying knee angles that can occur in a frontal plane. One of these secondary components is selected and connected to the second shell, for example, by screws. Preferably, the first component is selected from several first components and / or the second component from several secondary components. Preferably, the components are positioned laterally, i.e., on the outside. In some applications, it is advantageous to position the components medially. It is important that both components are positioned on the same side, i.e., both laterally or both medially.

[0018] The second shell preferably has attachment points that allow the second fitting part to be positioned on the second shell in different locations and / or orientations. For example, the second fitting part can be attached to the second shell in three, four, or five different arrangements that differ in orientation and / or position.

[0019] Alternatively, several second shells can be available, each with a second fitting component attached. One of these second shells is then selected and used for the procedure. This design is advantageous, for example, when the second body part can be described as accurately as possible for as many people as possible using a standard shape, and individual adjustment of the second shell is unnecessary for most wearers. In this case, it is beneficial to have several sizes and, if necessary, several positions and / or orientations of the second fitting component on the second shell available, allowing the desired combination to be selected.

[0020] In this releasable state, it is checked whether the pivot axis is in its target position. This involves verifying whether the pivot axis meets a predetermined criterion. For example, the natural joint connecting the two body parts can be moved, such as bent or straightened. In this case, it is measured whether, and if so, how far, the two shells move relative to the body parts on which they are attached. Often, it is sufficient to measure this for only one of the two shells. If this movement is less than a predetermined limit, the pivot axis is considered to be in its target position, and the process proceeds to step g). The two fitting parts are then attached to the respective application areas of the two shells.The clamping connection that existed up to this point between the first fitting part and the first connection area of ​​the first shell is replaced by a permanent connection, such as a screw connection, and / or converted into a non-removable connection, such as an adhesive bond or a rivet connection. If necessary or desired, a connection between the second fitting part and the second shell can also be replaced by a permanent connection, such as a screw connection, or converted into a non-removable connection by, for example, gluing or riveting the fitting part to the shell.

[0021] If the pivot axis does not meet the predetermined criterion, it is assumed to be out of its target position, and the process continues with process step f) after inspection in process step e). Depending on the detected deviation of the pivot axis from its target position, the first and / or second fitting part is released from its respective attachment area and re-clamped in a different position and / or orientation. If the first fitting part is released from the first attachment area of ​​the first shell, the first orientation and / or the first position can be changed before the first fitting part is re-clamped to the first attachment area. If the second fitting part is released from the second attachment area of ​​the second shell, the second orientation and / or the second position can be changed before the second fitting part is re-positioned at the second attachment area.After the loosened fasteners have been reattached, procedure step e) is performed again. This involves checking once more whether the pivot axis is now in its target position.

[0022] If a second shell with a permanently mounted second fitting part is used, the shell with the fitting part can be exchanged for a different combination of second shell and second fitting part in this step.

[0023] To enable this procedure, each of the two shells has a connection point. The shells are made of a rigid material, such as a plastic, or in particular a carbon fiber composite. These materials are lightweight, possess sufficient strength for use as an orthosis, and can be individually shaped to adapt to the specific characteristics of the wearer's body parts. They typically feature a padding element located on the side facing the wearer's body part, which provides cushioning so that the body part does not come into direct contact with the rigid shell material. This increases the comfort of the orthosis.

[0024] The connection area of ​​such a shell is preferably a thickening of the shell, which allows the fitting parts to be connected to the connection area as securely as possible, for example by means of screw connections or rivets. It is also advantageous if the shell has a flat surface in the connection area. The side of the respective fitting part facing the connection area is designed accordingly, so that the fitting part can contact the connection area in different positions and / or orientations, preferably resulting in full-surface contact in this area. This is most easily achieved with flat surfaces or cutouts of spherical surfaces, in which case the connection area is preferably convex and the area of ​​the fitting part contacting the connection area is concave.

[0025] Preferably, the second shell has a second clamping device by means of which the second fitting part is detachably clamped to the second connection area for provision in the second orientation and the second position. In this way, the second position and / or the second orientation can be easily changed should the result of the test in process step e) require or suggest this.

[0026] The first shell has a first clamping device, and the second shell has a second clamping device. The two clamping devices can be identical, but they need not be. Preferably, they are different. This makes it possible to accommodate shells that may be very different in size and / or shape, intended for different body parts. The respective clamping devices are part of their respective shells, but are not integrally formed with them. They are detachably connected to the shell and can be removed, which is particularly advantageous for attaching the fitting parts to the respective connection area in process step g).

[0027] The first clamping device is preferably designed such that the first fitting part can be clamped in different orientations and / or different positions on the first connection area. The second clamping device is preferably designed such that the second fitting part can be clamped in different orientations and / or different positions on the second connection area.

[0028] Advantageously, in step g), the first fitting part is screwed onto the first connection area and / or the second fitting part onto the second connection area. For this purpose, after inspection in step e), holes are drilled into the respective connection area. Preferably, the first fitting part and / or the second fitting part has corresponding markings, for example, through which markings can be transferred to the respective connection area when the fitting part is clamped in place. After this has been done, the respective fitting part can be removed from the connection area to allow the insertion of fasteners or receptacles for such fasteners, for example, holes into which sleeves with an internal thread can be inserted. The use of sleeves with an internal thread represents a preferred embodiment of the method.After holes have been drilled into the connection area of ​​the respective shell, the sleeves can be inserted into these holes and fixed there, for example, by positive locking or with an adhesive. Subsequently, screws with an external thread corresponding to the internal thread can be inserted through the openings of the respective fitting part and screwed into the sleeves to connect the fitting part to the connection area of ​​the respective shell. Advantageously, to attach the fitting parts in step g), the two fitting parts are separated from each other. This is preferably done by splitting and separating the joint. Alternatively, the fitting parts are attached to a separate joint element, from which they are removed in this case. In this embodiment, the combination of joint and shells is easier to handle and less complex to process.After the two fitting parts have been connected to the respective connection area of ​​the two shells, they are again connected to each other in a pivotable manner around a pivot axis, so that the two shells connected in this way can be pivoted relative to each other around the pivot axis.

[0029] In a preferred embodiment, after the fitting parts have been attached in step g), a follower joint or a driven joint is attached to the joint. Preferably, the joint has receiving elements on both fitting parts, for example, plug-in elements such as pins or positive locking elements such as screws, in order to be able to arrange a further component.

[0030] The invention further solves the stated problem by providing a set for manufacturing an orthosis using one of the methods described herein, wherein the set comprises a first shell with a first connection area and a first clamping device, a second shell with a second connection area, and a joint with a first fitting part and a second fitting part, which are pivotably arranged relative to one another about a pivot axis. A method of the type described herein can be carried out with such a set. The properties and features of the individual components used in the method, as described above, are preferably implemented in the set.

[0031] Preferably, the second shell has a second clamping device.

[0032] Preferably, the first clamping device comprises a clamping lever and a clamping plate with an opening through which the clamping lever can pass, the first fitting part having a recess through which the clamping lever can pass. The clamping lever preferably has a tension element, for example a wire rope, at one end of which a positive locking element, for example a screw element, is located. In the first connection area of ​​the first shell, a corresponding counter element, for example a recess with an internal thread, is provided so that the tension element of the clamping lever can be connected to the first connection area of ​​the first shell. At the opposite end, there is an eccentric clamp, which has been known in the art for a long time.

[0033] To clamp the first fitting part to the first connection area using this first clamping device, the pull element is first guided through the opening in the clamping plate and then through the recess in the fitting part. The pull element is first removed from the first connection area. After the clamping plate and the fitting part have been placed onto the pull element, the pull element is positively engaged with the first connection area. By actuating the eccentric clamp, the fitting part can now be clamped to the first connection area using the clamping plate. The eccentric clamp reduces the distance between the side of the fitting part facing the first connection area and the connection area itself, thus creating a clamping effect.When the eccentric clamp is actuated again, it returns to its original position and the aforementioned distance increases again, thus reducing or completely eliminating the clamping force and allowing the first fitting part to move relative to the first connection area. The extent of this movement is determined by the size of the recess in the first fitting part. Preferably, the clamping lever is detachably connected to the first connection area, preferably by screws.

[0034] In a preferred embodiment, the first and / or second clamping device is equipped with a clamping frame, and the second connection area has a rib. The clamping frame is designed such that a portion of the second fitting part and the rib can be inserted into the clamping frame and bonded together. The clamping frame preferably has a lower frame and an upper frame, the distance between which is adjustable. For this purpose, screws are provided, for example, to connect the upper frame to the lower frame. To connect the second fitting part to the rib of the second connection area, a portion of the second fitting part and the rib are guided between the upper and lower frames of the clamping frame. Subsequently, the distance between the upper and lower frames is reduced until a clamping effect is achieved.Of course, other configurations of a clamping frame are also possible, where the clamping frame has, for example, a top plate and a bottom plate, or a top strip and a bottom strip. The important thing is that there are two elements whose distance between them can be increased and decreased.

[0035] Preferably the second shell has a base body wherein there is a gap between the base body and the bridge, which is preferably large enough to accommodate the part of the second fitting part that is inserted into the clamping frame.

[0036] Advantageously, the first and second fitting parts are detachably attached to each other. Preferably, the two fitting parts form the joint and are thus detachably attached to each other so that they can pivot about the pivot axis.

[0037] Advantageously, the joint is designed as a hinge joint. It preferably has a fixed pivot axis about which the two mating parts can pivot relative to each other. Pivoting about any other axis is not possible. The joint can also be designed as a pseudo-joint. A pseudo-joint allows pivoting of the two mating parts relative to each other but does not have a fixed pivot axis. Such a pseudo-joint is preferably designed as a chain joint, which has at least two pivot axes that preferably run parallel to each other. One chain link is pivotably connected to the first mating part, and another chain link is pivotably connected to the second mating part. In the smallest embodiment of a chain joint, there is only one chain link, which is pivotably connected to both the first and the second mating part. The two pivot axes preferably run parallel to each other.Other embodiments of a pseudo-joint have at least one elastic element, for example a leaf spring, a coil spring and / or another spring element, by whose elastic deformation the two mating parts can pivot relative to each other. Preferably, the spring elements are part of the mating parts or the mating parts themselves are designed as spring elements.

[0038] The joint can have more than one degree of freedom, meaning it can allow more than one movement between the two mating parts. This applies, firstly, to rotational degrees of freedom. The joint can allow pivoting movements of the two mating parts around more than one axis. Secondly, it applies to translational degrees of freedom. Longitudinal displacement of the two mating parts relative to each other is also preferably possible in at least one, and optionally in more than one, direction.

[0039] Preferably, the first and / or second fitting part has multiple openings adapted to the first and / or second connection area such that at least three of these openings are located in the respective connection area, regardless of the position and orientation in which the fitting part is clamped to the respective connection area by the clamping device. The at least three openings do not need to be the same for every position and orientation. The only important factor is that at least three of these openings are present, regardless of the fitting part's position and orientation relative to the connection area. These openings are used during joint assembly to guide fasteners through the openings in the fitting parts and connect them to the connection area, thus securing the fitting parts to the connection area.

[0040] In a preferred embodiment, the first fitting part and / or the second fitting part has at least one fastening element to which a follower joint or a driven joint can preferably be attached such that a pivot axis of the follower joint or the driven joint coincides with the pivot axis of the joint.

[0041] Preferably, the follower joint or the driven joint is part of the set.

[0042] With the aid of the accompanying figures, an embodiment of the present invention is explained in more detail below. The figures show:

[0043] Figures 1 to 10 show various intermediate steps in the manufacture of an orthosis according to an embodiment of the present invention.

[0044] Figure 11 shows an orthosis manufactured according to an embodiment of the present invention and

[0045] Figure 12 shows an orthosis, manufactured according to another

[0046] Exemplary embodiment of the present invention, in the applied state.

[0047] Figure 1 shows a leg of a supporter, on which a first shell 2 is arranged on the thigh, forming the first body part 4. A second shell 6 is arranged on the lower leg, forming the second body part 8. The first shell 2 is to be connected to the second shell 6 by a joint, which is not shown in Figure 1. The first shell 2 has a first connection area 10, and the second shell 6 has a second connection area 12. A first fitting part of the joint is arranged on the first connection area 10, and a second fitting part of the joint is arranged on the second connection area 12. The double arrows indicate that the two connection areas 10 and 12 are not aligned. This misalignment must be compensated for by the appropriate joint. To select the correct joint with the correct fitting parts, a template 14 is used to facilitate the correct selection.The second connection area 12 has a web 16 arranged such that a gap 18 is located between the web 16 and a base body of the second shell 6. In Figure 1, the right end of the mold line 14 is located in this gap. Figure 2 shows how a second fitting part 20, which is part of the selected joint, is inserted into a second clamping device that has a clamping frame 22. The clamping frame 22 has a lower frame 24 and an upper frame 26, the distance between which is adjustable by screws 28. The second fitting part 20 is inserted between the lower frame 24 and the upper frame 26 and can therefore be clamped between them and thus releasably fixed by tightening the screws 28, thereby reducing the distance between the lower frame 24 and the upper frame 26.

[0048] Figure 3 shows several screws 28 that limit the range of motion of the second fitting part 20 within the clamping frame 22 in two directions that are perpendicular to each other. The lines of freedom are represented in Figure 3 by the crossed double arrows. The rotational degree of freedom of the second fitting part 20 in the clamping frame 22 is illustrated by the ring arrow surrounding the crossed double arrows. The second fitting part 20 can only perform movements corresponding to these three degrees of freedom within the clamping frame 22 if the distance between the lower frame 24 and the upper frame 26 is large enough and no clamping effect occurs. The possible range of the corresponding movements is limited by the screws 28.

[0049] Figure 4 shows a first fitting part 30 of the joint, which is to be arranged on the first connection area 10 of the first shell 2. The first fitting part 30 has a recess 32. A first clamping device includes a clamping lever 34 and a clamping plate 36. The clamping lever 34 has a tension element 38 that is guided through an opening in the clamping plate 36 (not visible in the figure). In other words, the clamping plate 36 is threaded onto the tension element 38 of the clamping lever 34.

[0050] In this state, the tension element 38 is guided through the recess 32 of the first fitting part and detachably fastened by means of a threaded element at the end of the tension element 38 into a bore with a corresponding mating thread in the first connection area 10 of the first shell 10. Since the clamping plate 36 is larger than the recess 32 of the first fitting part 30, the situation shown in Figure 6 results.

[0051] The first fitting part 30 is located between the first connection area 10 of the first shell 2 and the clamping plate 36. Figure 6 shows the released position of the clamping lever 34. The first fitting part 30 is therefore not clamped, but can be moved relative to the first shell 2 in two mutually perpendicular directions, which are again illustrated by the two crossed double arrows. Movement corresponding to one rotational degree of freedom is also possible, which is illustrated by the ring arrow surrounding the two crossed double arrows. The range of movement in the respective directions is limited by the size and position of the recess 32 in the first fitting part 30 relative to the tension element 38 of the clamping lever 34.

[0052] In Figure 7, the clamping lever 34 has been moved into the clamping position. In this state, the first fitting part 30 is clamped between the clamping plate 36 and the first connection area 10 of the first shell 2. In this state, it is checked whether a pivot axis of the joint 40 coincides with the natural pivot axis of the natural joint of the support. If not, in the illustrated embodiment, the first clamping device and / or the second clamping device can be released. Then the first fitting part 30 and / or the second fitting part 20 can be realigned relative to the respective connection area 10, 12.

[0053] If the pivot axis of the joint 40 is sufficiently well aligned, the two fitting parts 30, 20 are finally fixed to their respective connection areas 10, 12. This is illustrated for the first fitting part 30 in Figure 8. The clamping lever 34 is in the clamping position. The first fitting part 30 has several openings 42. Threaded sleeves 44 are inserted into the underlying first shell 2 through some of these openings 42. For this purpose, holes are drilled into the shell into which the threaded sleeves are inserted. The first fitting part 30 can then be screwed to the first connection area 10 of the first shell 20 by means of screws (not shown) that engage in the threaded sleeves.

[0054] Figure 8 shows that the first fitting part 30 has several fastening elements 46 on which a driven joint or a driven joint can be arranged. Figure 9 shows how such a driven joint 48 is positioned on the fastening elements 46. In Figure 10, the driven joint 48 is fastened to the fastening elements (not shown) with screws 50.

[0055] Figure 11 shows an orthosis manufactured according to a further embodiment of the present invention. The first shell 2 with the first connection area 10, to which the first fitting part 30 is arranged, is visible. The first fitting part 30 is connected to the second fitting part 20, which together form the joint 40 in this embodiment. The second fitting part 20 is arranged at the second connection area 12 of the second shell 6. A rail 52 is arranged on the second shell 6, which is designed as a lower leg shell, and an ankle joint 54 is attached to this rail. The orthosis shown in Figure 11 has a foot section 56, which is arranged at the ankle joint and is therefore pivotable relative to the second shell 6. Such ankle joints can have spring elements by which a pivoting movement is spring-loaded, at least from a predetermined pivot angle.The springs and the force they generate can be designed differently or identically for both pivot directions. Such ankle joints are known, for example, from DE 10 2017 112 997 A1 or DE 10 2019 135 544 A1, the contents of which are incorporated in full by reference.

[0056] Figure 12 shows the orthosis from Figure 11 for a left leg in its worn state. The foot section is positioned inside a shoe, which provides additional stability. In Figure 12, the orthosis has been fitted with a friction joint 48, as described with reference to Figures 9 and 10. (List of reference symbols)

[0057] 2 first bowl

[0058] 4 first body part

[0059] 6 second bowl

[0060] 8 second body part

[0061] 10 first connection area

[0062] 12 second connection area

[0063] 14 Template

[0064] 16 Bridge

[0065] 18 spaces

[0066] 20 second part

[0067] 22 clamping frames

[0068] 24 lower frame

[0069] 26 upper frame

[0070] 28 screw

[0071] 30 first part

[0072] 32 recess

[0073] 34 clamping levers

[0074] 36 clamping plate

[0075] 38 Pull element

[0076] 40 joint

[0077] 42 Passage

[0078] 44 Threaded sleeve

[0079] 46 Fastening element

[0080] 48 driven joint

[0081] 50 screws

[0082] 52 rail

[0083] 54 Ankle joint

[0084] 56 Foot section

Claims

<• G in treal kmct uma ipr Lo pienr tsy Ottobock SE & Co. KGaA Lawyer's File: Max-Näder-Straße 15 0108-2062 PCT-1 37115 Duderstadt Germany Date: September 19, 2025 Patent claims 1. Method for manufacturing an orthosis which - a first shell (2) for arrangement on a first body part (4) of a carrier with a first attachment area (10) and a first clamping device, - a second shell (6) for placement on a second body part (8) of the carrier with a second attachment area (12), - and a joint (40) with a first fitting part (30) and a second fitting part (20) which are pivotably arranged about a pivot axis, the method comprising the following steps: a. Arranging the first shell (2) on the first body part (4), b. Arranging the second shell (6) on the second body part (8), c. Detachably clamping the first fitting part (30) in a first orientation and a first position on the first connection area (10) by means of the first clamping device, d. Providing the second fitting part (20) in a second orientation and a second position on the second connection area (12), e. Checking whether the pivot axis is in a target position, f.Loosening the first fitting part (30) and / or second fitting part (20) and changing the first orientation and / or the first position and / or the second orientation and / or the second position if the pivot axis is not in the target position and rechecking, g. Attaching the first fitting part (30) to the first connection area (10) in the first position and the first orientation and providing the second fitting part (20) to the second connection area (12) in the second position and the second orientation if the pivot axis is in the target position.

2. Method according to claim 1, characterized in that the second shell (6) has a second clamping device by means of which the second fitting part (20) is detachably clamped to the second connection area (12) for provision in the second orientation and the second position.

3. Method according to claim 1 or 2, characterized in that the first fitting part (30) is selected from several first fitting parts and / or the second fitting part (20) is selected from several second fitting parts.

4. Method according to claim 1 or 2, characterized in that the first fitting part (30) is screwed onto the first connection area (10) and / or the second fitting part (20) is screwed onto the second connection area (12) for fastening in step g), for which purpose bores are made into the respective connection area (10, 12) after testing in step e).

5. Method according to one of the preceding claims, characterized in that, in order to fasten the fitting parts (30, 20) in step g), the first fitting part (30) is separated from the second fitting part (20).

6. Method according to one of the preceding claims, characterized in that after the fitting parts (30, 20) are attached in step g), the two fitting parts (30, 20) are again pivotably connected to each other about the pivot axis and preferably a follower joint or a driven joint (48) is attached to the joint (40).

7. Set for manufacturing an orthosis using a method according to one of the preceding claims, wherein the set - a first shell (2) with a first connection area (10) and a first clamping device, - a second shell (6) with a second connection area (12), and - a joint (40) with a first fitting part (30) and a second fitting part (20) which are arranged to pivot about a pivot axis.

8. Set according to claim 7, characterized in that the first and / or the second clamping device has a clamping lever (34) and a clamping plate (36) with an opening through which the clamping lever (34) can be passed and the first fitting part (30) has a recess (32) through which the clamping lever (34) can be passed.

9. Set according to claim 8, characterized in that the clamping lever (34) is detachably connected to the first connection area (10), preferably screwed on.

10. Set according to one of claims 7 to 9, characterized in that the first and / or the second clamping device has a clamping frame (22) and the second connection area (12) has a web (16), wherein the clamping frame (22) is designed such that the web (16) and a part of the second fitting part (20) can be inserted into the clamping frame (22) and clamped together.

11. Set according to claim 10, characterized in that the second shell (6) has a base body and there is a space (18) between the base body and the bridge (16), which is preferably large enough to accommodate the part of the second fitting part (20).

12. Set according to one of claims 7 to 11, characterized in that the first fitting part (30) and the second fitting part (20) are detachably attached to each other.

13. Set according to one of claims 7 to 12, characterized in that the first fitting part (30) and / or the second fitting part (20) has several passages (42) which are adapted to the first connection area (10) and / or the second connection area (12) such that at least three of these passages (42) are located in the respective connection area (10, 12), regardless of the position and orientation in which a fitting part (20, 30) is clamped to the connection area (20, 30) by means of the respective clamping device.

14. Set according to one of claims 7 to 13, characterized in that the first fitting part (30) and / or the second fitting part (20) has at least one fastening element (46) to which a follower joint or a driven joint (48) can preferably be attached such that a The pivot axis of the follower joint or the driven joint (48) coincides with the pivot axis of the joint (40).

15. Set according to claim 14, characterized in that the follower joint or the driven joint (48) is part of the set.

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