Orthosis, orthosis or prosthesis components, and method for the production thereof

A method for producing orthosis or prosthesis components for receiving or for fastening to a body part, the method including: applying a base layer to a support corresponding in form to the form of the body part, arranging multiple fastening elements having a base and an interlocking element protruding from the base, on the base layer in defined positions relative to one another, the base of the fastening element resting on the base layer or facing towards the base layer, placing at least one layer of a fiber composite material on the base layer and embedding the base, the interlocking element remaining accessible from the side facing away from the base layer, and curing the at least one fiber composite material layer.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a U.S. National Entry and claims priority to PCT International Patent Application No. PCT/EP2019/056581, filed 15 Mar. 2019, and entitled “ORTHOSIS, ORTHOSIS OR PROSTHESIS COMPONENTS, AND METHOD FOR THE PRODUCTION THEREOF”, which claims priority to Germany Patent Application No. 10 2018 106 573.6 filed 20 Mar. 2018, the entire disclosures of which are incorporated herein by this reference.

TECHNICAL FIELD

The invention relates to a method for the production of orthosis or prosthesis components for receiving or for fastening to a body part, and also to orthosis and prosthesis components, and to an orthosis composed of a plurality of orthosis components.

BACKGROUND

Orthosis or prosthesis components for receiving or for fastening to a body part are in particular prosthesis sockets, into which a stump of a limb is inserted, or orthosis shells or brackets, which are placed onto the body and fastened thereto in order to be connected, across a joint, to a second orthosis component via a joint device.

Prosthesis sockets are often produced from fiber-reinforced plastics which are placed onto supports, impregnated with resin and then cured. The supports can be designed as standard models or can be created on the basis of a cast of the respective stump. An anchor plate for securing a pyramid adapter or an adapter receptacle is cast in or fastened at a distal end of the prosthesis socket, such that the prosthesis socket can be connected to a distal joint device and to distal prosthesis components.

Orthosis components for receiving body parts or for fastening to body parts can be produced from plastic components. These components, which can be designed as shells or brackets or the like, can likewise be produced from fiber-reinforced plastic materials. The orthosis components can often be secured to the body part via fastening devices such as straps or buckles. By way of the fastening devices, the limb is enclosed and, if appropriate, the orthosis components are elastically deformed. Accordingly, the orthosis components are elastically deformable to a limited extent.

In order to produce orthoses with orthosis components for bearing on and receiving body parts or limbs, joint devices together with the orthosis components are secured and laminated on a model of the limb, in the case of individually tailored orthoses. Alternatively, fastening elements for joint devices are held in an orientation relative to each other via fixing devices, so-called dummies or space holders, which have to remain in situ during the curing and production of the orthosis components.

SUMMARY

The object of the present invention is to make available a method for the production of orthosis or prosthesis components for receiving a body part or for fastening to a body part, said method being able to be carried out more easily and more cost-effectively. The aim is to permit simple and safe fastening of joint components and functional components and to ensure that they are fastened according to requirements.

According to the invention, this object is achieved by a method and by the orthosis or prosthesis component or the orthosis composed of a plurality of such orthosis components disclosed herein. Advantageous embodiments and developments of the invention are disclosed in the description and the figures.

The method according to the invention for the production of orthosis components or prosthesis components for receiving a body part or for fastening to a body part involves firstly applying a base layer to a support that corresponds to the shape of the body part. The support can be configured as a cast of the body part, a modified cast of the body part, a molding of the body part or of a modified body part produced in some other way, or the body part itself. In the case of a cast, the modification can be made by removing or adding material or by applying a padding layer or, in the case of a support produced in another way, by modification of the data record such that, for example after optical detection or some other form of detection of the outer shape of the body part or of the stump, the data record is changed, for example smoothed, such that in the production of the physical support, for example by milling from a blank or by primary forming, for example by 3D printing, the corresponding support is produced. The base layer can be initially flexurally slack and of a curing type. Alternatively, provision is made that the base layer has such great inherent stability that, after forming on the support or onto the support, for example the cast, or after application to the body part as such, it does not change or does not appreciably change shape, particularly if the base layer is handled suitably carefully in the further course of handling. Before fastening elements are applied to the base layer, the base layer must have a sufficient inherent stability, which can be achieved by curing, if appropriate at elevated temperatures.

A plurality of fastening elements are then arranged on the base layer at defined positions relative to each other, wherein the fastening elements have a base from which at least one form-fit element protrudes. By way of the form-fit element, it is possible to secure further components of a prosthesis or orthosis to the prosthesis component or orthosis component, for example an actuator or a joint device. A form-fit element is also understood as a screw or a threaded rod. By arranging the fastening elements in previously defined positions relative to each other, it is possible to choose from a pool of components with standardized connection devices, in order then to secure them to the respective orthosis component or prosthesis component. It is thus possible, for example, to adapt orthosis components individually to the respective patient or orthosis user and to arrange different actuators or joint devices or also correction devices on the components in order, for example, to adapt to progress in the recovery process or to react to changes in circumstances, for example to worsening disorders. The base of the respective fastening element, in particular of all the fastening elements arranged on the base layer, either bears on the base layer or faces toward the base layer. The base preferably makes available an enlarged surface in relation to the form-fit element, in order to ensure better allocation and, if appropriate, introduction of force. The surface of the base facing toward the base layer can bear directly on the base layer or can be assigned to the base layer via an intermediate part, for example a spacer element or a formable, preferably curable compound. After the fastening elements have been arranged, at least one layer of a fiber composite material, for example of a prepreg, is applied to the base layer and the base embedded, wherein the form-fit element remains accessible from the side facing away from the base layer. By virtue of the accessibility of the form-fit element from the side facing away from the base layer, it is possible to secure a further component to the fastening element after the production of the orthosis component or prosthesis component. The at least one layer of the fiber composite material is then cured and the orthosis component or prosthesis component thus finished.

In a development of the method, provision is made that the base layer is connected to the at least one fiber composite material layer, and the base of the fastening element is laminated in between the base layer and the at least one fiber composite material layer. By means of the base layer being connected to or applied to the fiber composite material layer, the dimensionally stable orthosis component or prosthesis component is at least partially covered by a layer arranged on the inner face of the base of the fastening element. This prevents the fastening element from being able to be separated from the fiber composite material layer. The base layer itself can also be configured as a fiber composite material layer, for example from a prepreg, such that a permanent and rigid connection is provided for securing the fastening element with form-fit engagement to the inner face of the applied fiber composite material layer. The base layer can be removed from the at least one fiber composite material layer after production of the orthosis or the orthosis component.

In a development of the method, the form-fit element is formed or arranged on or in a shaft, wherein the shaft is partially embedded in the at least one fiber composite material layer and partially protrudes from the fiber composite material layer. The shaft protrudes from the base of the fastening element, wherein the base has a larger cross section than the shaft, such that a shoulder forms on which the applied layer of the fiber composite material bears. By virtue of the partial protrusion of the shaft, it is possible to keep the form-fit element easily accessible, so as to be able to secure the orthosis devices or prosthesis devices that are to be arranged on the orthosis component or prosthesis component.

The shafts of the plurality of fastening elements can be oriented parallel to each other. In particular, shafts of one group of fastening elements that are arranged on a particular orthosis device can be oriented parallel to each other. A particular orthosis component is, for example, an orthosis component which is arranged proximally or distally with respect to a joint axis, for example a thigh shell or thigh bracket and a lower-leg shell or lower-leg bracket. If the shafts of all of the fastening elements are oriented parallel to each other, this facilitates the mounting of the elements that are fastened or are to be fastened thereto, for example a joint device or actuator. The mutually parallel shafts of one group can be arranged tilted in relation to the parallel orientation of the shafts of another group.

In a further development of the invention, provision is made that at least one binding surface is arranged or formed on the fastening element, which binding surface is spaced apart from the base and is not covered by the at least one fiber composite material layer. The binding surface makes available a defined surface area for the arrangement of a further device, for example a damper or a joint device, and permits the precise allocation thereof and a firm connection thereof via the form-fit element. If all the binding surfaces of all the fastening elements on an orthosis component or prosthesis component are freely accessible, it is made easier to secure further components to the orthosis component if the corresponding contact surfaces or binding surfaces thereof likewise lie in one plane or are at least oriented parallel to each other. All of the binding surfaces preferably lie in one plane or are at least oriented parallel to each other in parallel planes, as a result of which a precise orientation of the device to be secured on the orthosis component or prosthesis component is possible.

The base of the fastening element can be fixed on the base layer, for example adhesively bonded, or fixed on the base layer using a filler compound. An adhesive layer, which is generally relatively thin, permits no or virtually no height compensation. Besides permanent fixing of the base of the fastening element and therefore of the fastening element itself to the base layer, a filler compound generally provides a height compensation in order to permit an allocation of all the fastening elements in a defined plane relative to each other or at least in a plane region relative to each other. All of the fastening elements are preferably oriented parallel to each other with respect to a reference plane, at least as regards the fastening elements on an orthosis component on a single limb part. A limb part is seen as a part of a limb that is connected, via a joint, to another limb part or to another body part.

In a development of the invention, provision is made that the support is configured as a positive model of the body part, and the curing of the at least one fiber composite material layer, if appropriate in conjunction with the connection of the base layer to the at least one fiber composite material layer, takes place on the support. On account of the arrangement and optionally the fastening and fixing of the fastening elements on the base layer, it is possible to preform the orthosis component or prosthesis component and to keep them oriented relative to each other without an additional fixing device or an external fixing element and to obtain the curing and stabilizing of the prosthesis component or orthosis component. If the base layer is sufficiently stable, the curing of the at least one fiber composite material layer can also take place without the support. For the final production of the orthosis component, further elements or components can be arranged on the orthosis component or prosthesis component, for example padding devices or the like.

In a development of the invention, provision is made that recesses are formed in the at least one applied fiber composite material layer, through which recesses parts of the fastening elements are guided, for example the shaft which protrudes from the base, or also form-fit elements which protrude from the base, such as projections, hooks or the like, via which a form-fit locking to the at least one fiber composite material layer and therefore an additional securing of the fastening element on the at least one composite material layer is achieved. By means of these additional formations or arrangements of projections on the base of the fastening element, the fastening element can be secured against rotation on or in the fiber composite material layer or orthosis component or prosthesis component.

In a development of the invention, provision is made that the fastening elements or the at least one fastening element are secured against rotation and fastened non-releasably to the orthosis component or prosthesis component. This can be achieved by the shaping of the base and/or of the shaft, which can be non-round, angular or equipped with projections or protruding elements. The non-releasability is achieved in particular by embedding the base and the form-fit element or the shaft in the at least one fiber composite material layer. In the base and/or in the form-fit element and/or the shaft, projections or recesses can be formed which come into form-fit engagement with parts of the fiber composite material layer, such that a rotation and/or displacement and axial shift in the longitudinal extent of the shaft is prevented.

The fastening elements can be covered completely by the base layer on the side of the orthosis component or prosthesis component facing toward the body part, such that a closed surface is present on the inner face, i.e. on the side facing toward the user of the prosthesis component or orthosis component, and this increases the wearing comfort. In addition, this prevents the fastening element from being pressed out of the orthosis component or prosthesis component in the direction of the orthosis user or prosthesis user.

In a development of the invention, provision is made that binding surfaces of all the fastening elements are pre-positioned in a common plane or in a region between two parallel planes, wherein the binding surfaces on the fastening elements are positioned spaced apart from the base. The orientation along parallel planes does not have to be provided for groups to the other side of the joint axis. A spacing optionally present between the bases of the fastening elements and the base layer is filled via a compensating element or via a compensating compound, so as to be able to work with predefined fastening elements. A fastening plane for the binding surfaces is thus predefined, or at least a region between two planes is predefined within which the binding surfaces of the fastening elements have to be located. The distance present between the bases of the standardized, predefined fastening elements and the base layer which is configured individually to the respective user of the orthosis component or prosthesis component is then compensated via a compensating element or a compensating compound. The compensating element can serve at the same time for fixing on the base layer; the same applies to the compensating compound, which is configured for example as a filler compound or as a curable adhesive having a sufficient strength and stability to hold the fastening elements on or in the orthosis component or prosthesis component.

In a development of the method, provision is made that the fastening elements are pre-positioned in predetermined positions relative to each other and to a joint axis of a joint of the body part and are arranged on or at least assigned to the base layer. If direct contact between the respective base and the base layer is possible, the positioning and optionally the fixing is carried out without interposition of a compensating element or a compensating compound; if this is not possible, the spacing between the base and the base layer is compensated via a compensating element or a compensating compound. The fixing is obtained either via the filler compound or via an adhesive which forms no connecting layer or no appreciable connecting layer between the base and the base layer. The positions of the fastening elements relative to each other and in particular the positions of binding surfaces of all the fastening elements on a common orthosis component are predefined and correspond to the fastening devices or binding points of components which are arranged or are intended to be arranged on the orthosis component or prosthesis component.

The fastening elements can be arranged on a holder or a positioning device and pre-positioned relative to each other before they are arranged on or allocated to the base layer. After the fastening elements have been arranged on the base layer or allocated to the base layer and the fastening elements have been fixed on the base layer, the holder or the prosthesis device is removed.

In a development of the method, provision is made that in order to form an orthosis with a distal component and a proximal component, the at least one fiber composite material layer, which is applied to the base layer and embeds the base, is arranged in a region on the support corresponding to that of a natural joint and is then cured in order to form a main body. Before the curing, fastening elements are arranged proximally and distally from a joint axis of the natural joint and are embedded in the at least one fiber composite material layer. After the curing, the at least one fiber composite material layer of the main body and if appropriate also the base layer, if the latter is cured together with the applied fiber composite material layer, is separated in the region of the joint axis, in order to form from the main body the distal component and the proximal component of the orthosis. If no fiber composite material layer is applied to the base layer in the region of the joint axis, an orthosis main body with fastening elements secured thereon can likewise be obtained, wherein the region about the joint axis is formed only by the base layer. For separation and division into a proximal component and a distal component, only the base layer then has to be removed. Instead of the embodiment and design of two orthosis components on one support for producing an individual orthosis, an orthosis main body that spans a joint is produced, which is cured. In the orthosis main body, the fastening elements are secured for arranging a joint device or an actuator on the outside, wherein the securing of the fastening elements takes place at predetermined, standardized positions in predetermined orientations relative to each other. Both the orientation of the fastening elements or of the fastening element on the proximal component and the orientation of the fastening elements or of the fastening element on the distal orthosis component are predetermined and move within a predefined tolerance range.

Binding surfaces are preferably defined on the fastening elements, which binding surfaces are oriented parallel to each other and more preferably in a common plane in the respective orthosis component, i.e. in a proximal orthosis component and in a distal prosthesis component. The orientation of the binding surfaces on different components is likewise predefined and lies in a predefined tolerance range, in order to facilitate a facilitated allocation of the further components, in particular the joint device and an actuator.

All the binding surfaces of a component are preferably tilted about the same angle with respect to the orientation of the planes of the binding surfaces of the other component if tilting is needed, for example on account of the particular shape of the limb on which the joint-spanning orthosis is intended to be placed. After the arrangement in defined positions relative to each other and in a defined angle orientation within a certain tolerance range relative to each other, a separation process is then carried out in the region of the joint axis of the natural joint of the joint-spanning main body in order to separate the main body into a proximal component and into a distal component, in order thereafter to secure a joint device on the proximal component and the distal component via the fastening elements and to produce the orthosis. Of course, after the curing and the separation, further working of the orthosis components can take place, for example smoothing of the shape, deburring of the edges, and sealing, painting and padding, and also the fastening of fastening devices such as straps or the like.

To produce the orthosis with the orthosis components produced in the manner described above, a joint device is secured to the fastening elements via the form-fit elements, for example screwed on if the form-fit elements have a thread.

The orthosis or prosthesis component according to the invention for receiving a body part or for fastening to a body part has a base layer which can be arranged on a support shaped in a manner corresponding to the shape of the body part, wherein the support can be both the body part itself and also an impression or a model of the body part. At least one fastening element with a base and with a form-fit element protruding from the base is arranged on the base layer, wherein the base bears on and faces toward the base layer. The fastening element is embedded with at least one layer, preferably a plurality of layers of a fiber composite material, and the form-fit element remains accessible from the side facing away from the base layer after the fiber composite material layer or fiber composite material layers have been cured

In a development of the invention, provision is made that a plurality of fastening elements are embedded which have a shaft as form-fit element or with a form-fit element and at least one non-embedded binding surface, wherein the shafts of all the fastening elements of an orthosis component or of a prosthesis component are oriented parallel to each other. By arranging the shafts parallel to each other, it is possible to simplify the mounting of further components on the fastening element. The fastening elements are preferably arranged in groups, for example a group for the proximal component and a group for the distal component. The orientation of the fastening elements within a group is preferably uniform.

Binding surfaces are likewise arranged parallel to each other, such that corresponding binding surfaces on components which are secured to the orthosis components or prosthesis components can be easily oriented relative to each other and can be secured thereon in an easily exchangeable manner. All of the binding surfaces can be arranged in parallel or even in a common plane. Similarly, the binding surfaces of individual groups can be arranged in parallel or in a common plane. All of the binding surfaces of an orthosis component or prosthesis component preferably lie in a common plane or at least between two mutually parallel planes that are offset relative to each other. The common planes can also be tilted relative to each other and can be oriented relative to each other at an angle deviating from 180°.

The base layer can likewise be configured as a fiber composite material layer and can form a closed surface on the side of the orthosis component or prosthesis component facing toward the body part.

The fastening element can be embedded non-releasably in the at least one fiber composite material layer and in a manner secure against rotation.

The fastening element can have a non-round base and/or projections and/or recesses for the securing against rotation, which are embedded with form-fit engagement in the at least one fiber composite material layer and are held thereon.

A thread can be arranged and formed on the form-fit element or on the shaft. The thread can be configured either as an inner thread or outer thread, such that the fastening element acts as an anchoring screw or anchoring nut.

Fastening devices for securing the orthosis component or prosthesis component to a body part can be arranged on the orthosis component or prosthesis component, for example straps, buckles or also prosthesis liners for the implementation of suction socket technology.

An orthosis composed of a plurality of orthosis components, as have been described above, has at least one joint device secured to a plurality of fastening elements. An actuator can likewise be secured to a proximal orthosis component and to a distal orthosis component via fastening elements.

In a development of the orthosis, provision is made that the orthosis components are connected to each other to span a natural joint and have a predetermined separation point or a predetermined separation region in which the joint axis of the natural joint lies.

DETAILED DESCRIPTION

FIGS.1ato1dshow different views of a fastening element10, whereinFIG.1ashows a perspective overall view,FIG.1bshows a side view,FIG.1cshows a bottom view, andFIG.1dshows a further side view. The fastening element10has a base11which, in the illustrative embodiment shown, is substantially flat and plate-shaped. Bevels are formed at the edges of the base11in order to provide improved contact to a substrate or a support surface in order to form a smooth transition. In addition, connecting material or adhesive can be arranged between the bevels and fiber composite materials in order to fix the fastening element10thereon. The base11is non-round and has two flattened regions16at mutually opposite sides. Between the flattened regions16, the base11forms a radius, the continuation of which would lead to a circle shape. The contour of the base11thus corresponds to a circle with cut-off circle segments with parallel chords. A central bore with a form-fit element12in the form of an inner thread is formed in the middle of the base11. The inner thread12extends along the longitudinal extent of a shaft13, which protrudes from the base11. A binding surface14, which is substantially plane, is formed on the side of the shaft13remote from the base11. Lying opposite the binding surface14, a bottom surface15is formed on the base11; the binding surface11and the bottom surface15are oriented substantially parallel to each other. The shaft13is rotationally symmetrical, and the central bore with the inner thread12is formed coaxially with respect to the longitudinal extent of the shaft13. The shaft13is provided with a shoulder in the front third directed toward the binding surface10, that is to say the shaft13there has a smaller diameter than in the region of the base11. The size of the shoulder can vary. In particular, the shoulder is chosen such that layers of a fiber composite material applied to the base11reach as far as this shoulder or at least do not reach beyond the shoulder in the direction of the binding surface. The outer contour of the shaft13can also have other outer contours, in particular a non-rotationally symmetrical outer contour in order to secure against rotation in addition to the securing against rotation provided by the non-round configuration of the base11.

Recesses, projections or undercuts can also be arranged or formed on the fastening element10, in order to provide further securing to a base layer for producing a main body for an orthopedic device. The use of the fastening element10in connection with the production of orthopedic devices such as orthoses, prostheses or other orthopedic components is explained below. The base11serves to secure the fastening element10on a main body, while the form-fit element12serves to ensure that further components of an orthopedic device can be secured to the fastening element10, for example joints, actuators, dampers or other devices or components.

The production of an orthosis as an orthopedic device is explained in more detail with reference toFIGS.2to4.

FIG.2shows a schematic view of a support1which is shaped corresponding to the body part on which an orthosis or prosthesis is intended to be worn. In the illustrative embodiment shown, the support1is formed as a part of a leg with a thigh portion, a knee joint and a lower leg portion. As an alternative to an embodiment in the form of a leg, the support can also be configured in the form of an arm or part of an arm. It is also possible to configure the support1in any other form that is required in order to form an orthosis. If a prosthesis is to be produced, the support1can correspond only partially to the shape of the body of the patient or prosthesis user, i.e. where the stump is still present. The distal part of the support is then modeled, for example using a 3D computer method or in some other way.

A base layer2, which is formed from one or more blanks, is applied to the support1. The base layer2is preferably formed from a fiber composite material, for example from a prepreg or from another fiber composite material. In the illustrative embodiment shown, the base layer2is formed in one piece and extends over a joint axis3of a natural or assumed joint of the respective limb. In the illustrative embodiment shown with the support1as a thigh part, the base layer2covers the knee-joint axis3. The base layer2is sufficiently flexible to be able to conform to the surface contour of the support1. The support1can be modified according to the actual contour of the limb, for example by addition of material, smoothing of a 3D model or the like, for example in order to be able to arrange padding elements on the inner face of the orthosis or prosthesis that is to be produced. In the case of a prosthesis, it may be necessary for the prosthesis socket or the receiving device to be chosen larger, so as to be able to receive liners or other protective coverings without exerting too great a pressure on the body part.

The base layer2is of a closed configuration, i.e. not open for the passage of components such as fastening elements10that are applied to the base layer2. The base layer2can be fixed to the support1either mechanically or by an adhesive. The fixing is done in such a way that the base layer2is removable again after the orthosis or prosthesis has been produced.

FIG.3shows a next phase in the production of the orthosis components, in which phase fastening elements10, as have already been described with reference toFIG.1, are placed on the lateral surface of the base layer2, i.e. on the surface facing away from the support1. The fastening elements10are applied via the underside15, i.e. the surface of the base11facing away from the abutment surface14The fastening elements10, in the illustrative embodiment five fastening elements10, of which two are positioned in the distal region and three in the proximal region, are positioned on the base layer2preferably via a positioning device. The positioning device is explained in more detail further below. By means of the positioning device, the fastening elements10are arranged on the base layer2at defined spacings from each other and from the joint axis3. The positioning device is secured to or placed on a receptacle4, for example plugged on, screwed on or fixed via a magnetic lock. The receptacle4is preferably already arranged on the support1and protrudes through a recess in the blank of the base layer2. The receptacle4can be worked into the support1, for example cast in or inserted. It preferably has a thread, a sleeve or a peg, of which the longitudinal extent coincides with the knee-joint axis. Generally speaking, the longitudinal extent of the receptacle4should coincide with the joint axis about which an orthosis upper part pivots relative to an orthosis lower part or a proximal component pivots relative to the distal component of the orthosis.

The fastening elements10are fixed on the base layer2, for example by an adhesive, a filler compound, or by using a compensating material. The aim is that the fastening agent, such as filler or adhesive, does not deform during the subsequent processing of the orthosis. To produce the orthosis, the latter can be cured at high temperatures and under vacuum, which must not cause displacement of the fastening elements10or tilting of the fastening elements10.

After all of the fastening elements10have been fastened on the base layer2, the positioning device is removed, as will be explained in detail later. The fastening elements10and also the receiving device4remain securely on the outer or lateral surface of the base layer2.

At least one layer8of a fiber composite material with punched-out recesses is then placed over the shafts of the fastening elements10, wherein the recesses in the layer8of a fiber composite material are dimensioned such that the respective shaft can pass through, but not the base11. In this way, the base11of the fastening elements10is embedded between the base layer and an outer composite fiber material layer8. Predetermined separation lines6, along which separation can take place easily or more easily, can be worked into the outer fiber composite material layer8. In the illustrative embodiment shown, two predetermined separation lines6form a predetermined separation region in which the joint axis3and also the receiving device4lies before the anchor plate. After the separation at the predetermined separation lines6, a proximal component21and a distal component22of the orthosis are obtained, i.e. a thigh shell21and a lower-leg shell22, with fastening elements10laminated therein. The separation or removal of the predetermined separation region between the predetermined separation lines6is effected only after the base layer2together with the at least one fiber composite material layer8has been bonded to the outside and then secured on top of each other. This takes place, for example after application of an underpressure, in an oven at elevated temperatures. The fiber composite material layers8are preferably applied as far as the shoulder in the shaft13. The shoulder ensures that a sufficient material thickness is present in the region of the fastening elements. A fiber composite material layer8as blank with pre-formed recesses80, which correspond in terms of diameter to the shaft diameters of the shafts13and in terms of their positions to the positions of the fastening elements10on the base layer2, are shown on the left inFIG.4.

After the laminate material has cured and cooled, a main body20is present with a continuous base layer2on the inner side, fastening elements10placed thereon, and at least one layer, preferably a plurality of layers, of fiber composite material8which are connected to each other such that the fastening elements10are laminated in. After curing and cooling, the orthosis main body20is separated, for example sawn through, in the region of the predetermined separation points6, in order to separate the thigh shell or proximal orthosis component21from the lower-leg shell or distal orthosis component22. The orthosis components21,22are then removed from the support1, optionally re-worked and ground, provided with receptacles for fastening devices such as straps, and equipped with the necessary attachments such as joint devices, dampers or pads.

FIGS.5to7show the production sequence in a schematic sectional view. First, the anchor plate or the receptacle4is positioned on the support1, specifically in the region of the joint axis of the natural joint or of a compromise axis3. The base layer2is then applied to the outer or lateral surface of the support1and optionally fixed. The material of the base layer2can be plastically deformable and have low restoring forces, so as to allow it to bear as fully as possible on the outer surface of the support1. The spacing from the support1is indicated in order to make matters clearer.

FIG.6shows the state after the fastening elements10are applied to the lateral surface of the base layer2. The fastening elements10are positioned on the base2, in a manner aligned with the joint axis3, via a positioning device. It will be seen that the respective bases11of the fastening elements10should be arranged as close as possible to the surface of the base layer2. In the illustrative embodiment shown, the connection of the respective underside15of the respective base11of the fastening elements10is effected via a filler compound7, which at the same time evens out irregularities in the surface of the base layer2and ensures that the fastening elements10are rigidly anchored on the base layer2.

It will be seen fromFIG.6that all of the binding surfaces14lie in a respective plane E1, E2, wherein the plane E1stands for the fastening elements10of the proximal component21and the plane E2stands for the fastening elements of the distal component22. It will be seen fromFIG.6that the planes E1, E2in the illustrative embodiment shown do not lie parallel to each other or form a common plane. This would be the case if for example, in the illustrative embodiment, there were a completely straight leg on the lateral side or medial side. A more natural depiction is shown in which there is a lateral curvature both of the thigh and of the lower leg starting from the knee joint. In the illustrative embodiment shown, both planes E1, E2intersect each other in the joint axis3, thus resulting in a common section line, which is preferably orthogonal to the joint axis3. It is also possible that the binding surfaces do not lie exactly in a plane E1, E2, and instead there is a certain vertical offset. It is likewise possible that the planes E1, E2do not intersect each other in the joint axis3, for example because a vertical offset has been established. All the binding surfaces14of all the fastening elements10of an orthosis component21,22preferably lie on a common plane E1, E2. The longitudinal extents of all the bores, pegs or form-fit elements12such as inner threads or outer threads in the fastening elements10are preferably oriented parallel to each other, in each case with respect to an orthosis component. That is to say, all the longitudinal axes of the fastening elements10on the proximal orthosis component21are preferably oriented parallel to each other, likewise the longitudinal extents or longitudinal axes of the fastening elements10on a distal orthosis component22.

After the fastening elements10have been secured on the base layer2, several layers8of a composite fiber material are applied, as shown inFIG.7, for example resin-impregnated fiber mats, optionally with addition of further adhesives, hardeners, solvents or the like. The layers8of the fiber composite material or of the fiber composite materials can be applied in different orientations, in order to laminate in the bases11of the fastening elements10. For this purpose, recesses80or punched holes corresponding to the shape and the diameter of the respective shafts13are formed in the blanks of the fiber composite material layer8. Since the bases11are greater than the diameters of the shafts13, no fastening element10can be removed from the respective orthosis component21,22after the fiber composite material layers8have been connected to the base layer2. On account of the non-round configuration of the base11, all of the fastening elements10are secured against rotation. To increase the securing against rotation, it is possible for projections, hooks, undercuts or the like to be provided, so that the fastening elements10cannot rotate after the orthosis components21,22have been produced.

The binding surfaces14are not all covered by a fiber composite material layer8, so as to ensure accessibility to the form-fit elements12and to ensure a defined bearing of the components that are to be mounted. In order to avoid contamination of the form-fit element12, it can be secured. In the embodiment according toFIG.1, in which the form-fit element12is designed as an inner thread, this can be achieved for example by a screw which is unscrewed after the orthosis component has been produced. If the form-fit element12is designed as an outer screw, a screw cap can be screwed on in order to protect the thread. The same applies to other form-fit elements such as pegs, bores or the like. After the fiber composite material layers8have been applied, the orthosis main body20is produced on the support1under vacuum and at elevated temperatures. The predetermined separation points6are formed proximally and distally at the joint axis3, for example by impressions or cuts made in the fiber composite material layers8or simply by applying no or fewer fiber composite material layers8in the region between the predetermined separation points6.

After curing and separation of the orthosis components21,22from each other, other components can be secured to the fastening elements10.

FIG.8shows a variant of a knee-joint orthosis in which the proximal component21is designed as a thigh shell and the distal component22as a lower-leg shell. Fastening devices40, which are designed as straps, are arranged on both orthosis components21,22in order to secure the orthosis50to a leg. A joint device30with a hydraulic actuator35is secured to the no longer visible fastening elements, for example via screws. The joint device30has its pivot axis in the region of the joint axis of the natural joint. The position of the joint axis3on the joint device30is made safe by the exact positioning of the fastening elements relative to the joint axis3of the natural joint via a positioning device. The design of the orthosis components21,22in the form of the orthosis shells is adapted very effectively and individually to the shape of the respective orthosis wearer. The production of the orthosis can take place without previously arranging the joint device30or a hydraulic component35on the orthosis components21,22, which is extremely advantageous in respect of the high temperatures and negative pressures arising during manufacture, in particular for electronic controls. The nature of the manufacturing prevents any limit on the attachment parts that are to be used, such as dampers, controls or the like.

FIG.9shows a perspective view of a positioning device100for positioning and aligning fastening elements10(not shown), which are of the kind explained for example with reference toFIG.1. The positioning device100has a central body200on which two holders110,120are arranged pivotably about a pivot axis130. In the illustrative embodiment shown, a first holder110is provided for assigning and arranging the fastening elements10on the proximal orthosis component21, while the second holder120is provided for the fastening elements10on the distal orthosis component22. Both holders110,120have receiving devices111,121, which are designed as sleeves with through-bores through which fixing elements123can be guided. InFIG.9, the fixing elements123are shown only on the second holder120. On the receiving devices111,121, bearing surfaces112,122are formed for the upper face of the base11of the fastening elements10. The upper face of the base11is the side of the base11lying opposite the underside15. In the illustrative embodiment shown, all the bearing faces112,120are arranged on a common holder110,120in a common plane, in order to ensure that all of the fastening elements10lie in a common plane when they are arranged on the respective holder110,120and are secured there by the fixing elements123.

Arranged on the central body200is a fixing device240in the form of a screw via which the central body200is secured to the receptacle4which is fixed on the support1or the base layer2. The longitudinal extent of the fixing device240runs perpendicular to the pivot axis130and preferably intersects the latter, such that the longitudinal axis of the fixing device240is orthogonal to the pivot axis130. The longitudinal extent of the fixing device240is preferably flush with the longitudinal axis3of the joint device and of the natural joint axis or the compromise axis for the natural joint. When all of the bearing surfaces112,122are located in parallel panes or in a common plane, depending on how the planes of the bearing surfaces112,120are arranged, the positioning device100is located in a starting position. From this starting position, both the first holder110and the second holder120can be pivoted through a limited angle range, for example +/−10°, about the pivot axis130. Joint devices30or also other attachment parts may be sensitive in respect of a possible angular offset of their binding sites. By means of the positioning device100it is possible, besides the exact positioning of the fastening elements10relative to each other and to a joint axis3about a joint device30, to take account of this angular offset. There is the possibility of fixing the extent of the angular offset of the two holders110,120in advance. For example, if a maximum offset of the planes of the binding surfaces14of 10° is admissible, this maximum angle range can be set with the positioning device100. If, proceeding from the starting position, the first holder110is then applied to the base layer2and requires a pivoting in the lateral direction through 3°, proceeding from the starting position, a maximum pivot range of a further 7° in the lateral direction is available for the second holder120. If, with such a maximum setting, a satisfactory orientation of the undersides15of the bases11of all the fastening elements10is not possible, the whole positioning device100has to be offset further laterally, or the fastening elements10have to be secured to the base layer via a compensating compound or a filler compound.

The positioning device100is designed with axial symmetry.FIG.9shows an upper face, for example, whileFIG.10shows the underside. A comparison ofFIGS.9and10shows that identical receptacles for the fastening elements10are formed on both sides of the receiving devices111,112. The fixing device240can be removed from the central body200and re-inserted the other way round, such that the positioning device100is suitable both for a right leg and for a left leg and also for medial and also lateral positioning on base layers2.

InFIG.10, the fixing elements113in the form of screws are shown in all of the receiving devices111. The inner threads12according toFIG.1are designed corresponding to outer threads on the fixing elements113, so that assembly proceeds in such a way that, in each receiving device11, the shaft13is inserted with the binding surfaces in front into the bores of the sleeve-like receiving devices111. The fastening elements are fixed via the fixing elements113. It will be seen that the shape of the bearing surfaces112of the receiving device111corresponds to the shape and contour of the bases11, such that each fastening element is assigned and oriented in a defined manner on the respective holder110,120. A groove-like guide for the two bases11of the two fastening elements10is provided in the second holder120. Further insert elements such as rails or strengthening elements or spacers can be received therein, which elements can likewise be laminated in place. After the fastening elements10have been fixed inside the receiving devices111,121, the positioning device100is secured with the fixing device240in the receptacle4. A central screw150along the pivot axis130keeps the two holders110,120in a defined position relative to each other, preferably in the starting position in which all of the undersides15of the fastening elements10are oriented relative to each other in a common plane or at least in parallel planes. When the fixing by the central screw150is released, the two holders110,120are able to pivot about the pivot axis130within the predefined angle range.

FIG.11shows an exploded view of the positioning device100with the central body200, and the fixing device240which is guided through a bore inside the central body200and orthogonally intersects the pivot axis130. The fixing elements113can be seen, likewise the two holders110,120and the central screw150, which extends along the pivot axis130. Inside the central body200, an abutment element230is likewise mounted longitudinally displaceably in a bore210in the central body200. The bore210extends parallel to the pivot axis130.

Mating pieces115,120with bearing surfaces1153,1253, which interact with the bearing surfaces233at the two ends of the abutment element230, are arranged on the holders110,120via three screws. The interaction is explained below. In the illustrative embodiment shown, the mating pieces115,125are mounted in a fixed position on the respective holder110,120. There is also the possibility, for example by means of oblong holes, to permit a rotatability of the mating pieces115,125on the respective holder110,120. The angle range can be set via the rotation of the mating pieces115,125; the maximum angle range can be increased, for example, by exchanging the mating pieces115,125. It is likewise possible, for example by means of adjustment screws, to modify the position of the abutment surfaces1153,1253in order to set the angle range about which the first holder110can be pivoted relative to the second holder120about the pivot axis130. For this purpose, adjustment screws can be screwed into or out of the recesses in the mating piece115,125.

FIGS.12and13show the positioning device100in the same view. InFIG.12, proceeding from the starting position, the second holder120is pivoted counterclockwise about the pivot axis130to a maximum extent. InFIG.13, proceeding from the starting position, the first holder110is pivoted counterclockwise to a maximum extent. The maximum pivoting range is reached in both positions inFIGS.12and13Sectional views corresponding toFIGS.12and13are shown inFIGS.14and15.

FIG.14shows a section through the central piece200in the region of the abutment element230. In the sectional view, the abutment element230looks like a feather key, which is arranged displaceably inside the central piece200. InFIG.14, a rounded end region2330with corresponding bearing surfaces233is in abutment with a correspondingly shaped bearing surface1153in a recess in the mating piece115. The mating piece115is connected rigidly to the first holder in terms of rotation. The mating piece115is located in the starting position, in which the first holder110is correspondingly oriented. In this starting position, the abutment element230can be displaced to the maximum extent to the left parallel to the pivot axis130. In this way, the right-hand end of the abutment element230is brought out of the free space inside the mating piece125of the second holder120, such that the second holder120can move to the maximum extent in both directions. In the illustrative embodiment shown, the holder120was pivoted upward about the pivot axis, such that the bearing surface1253bears on the rounded bearing surface233of the right-hand end of the abutment element230. If both holders110,120were located in the starting position and the abutment piece230were located in the middle, both holders110,120would be able to pivot about the pivot axis130by the same angle until the bearing surfaces233,1153,1253came to bear on each other. The further the abutment element230is displaced in one direction or the other, the more the possible angle range of the other holder increases or decreases in the one pivoting direction or the other. If the bearing surfaces1153,1253of the mating pieces115,125are not of the same shape or symmetrical, different angle adjustment possibilities arise. In addition to a rounded shape of the bearing surfaces233,1153,1253, the latter can also have other shapes.

FIG.15shows the reverse position according toFIG.13: the abutment element230has been displaced to the maximum extent to the right, as a result of which the right-hand end of the abutment element230lies in the recess in the mating piece125and thus abuts the bearing surfaces1253. This results in a maximum pivotability of the first holder115about the pivot axis130.

An alternative embodiment of the abutment element230is shown inFIG.16in which, instead of a rounded configuration of the two end pieces2330, a straight, conical configuration of the end pieces2330and of the bearing surfaces233is present. A corresponding conical configuration of the bearing surfaces1153,1253permits a large bearing surface and therefore low surface pressure. The longitudinal displaceability of the abutment element230permits a simple adjustment. In the abutment element230, an oblong hole can be present through which a screw or a movement limiter can be inserted in order to limit the adjustment range of the holders110,120relative to each other. The abutment element230can be fixed in the respectively desired position. The oblique configuration of the bearing surfaces233,1153,1253imposes a displacement of the abutment element230upon contact along the displacement direction toward the opposite holder, as a result of which the adjustment angle thereof in both pivoting directions changes. The respective pivoting range of the holders can be modified within a predefined angle range according to the positions of the holders relative to each other. Provision is made that the holders110,120are held securely in the respectively found optimal position in which the fastening elements10are placed onto the base layer2. This can be done, for example, by clamping by the central screw115.