Patent Publication Number: US-2021169672-A1

Title: Positioning device and system formed of a positioning device and base body of an orthopaedic device

Description:
The invention relates to a positioning device for arranging and orienting a plurality of fastening devices on a base layer of a main body of an orthopedic device, and to a system formed of a positioning device and of a main body of an orthopedic device. Orthoses or prostheses are considered in particular as the orthopedic device, although it is also possible in principle to use the positioning device in conjunction with other orthopedic devices, for example exoskeletons. 
     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 can be 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. 
     The object of the present invention is to make available a positioning device, for arranging and orienting a plurality of fastening devices on a base layer of an orthopedic device, and a system formed of a positioning device and of a main body, with which fastening devices for additional components can be positioned relative to each other within admissible parameters in order to permit individualization of the orthopedic device in a simple manner. 
     According to the invention, this object is achieved by a positioning device having the features of the main claim and by a system having the features of the alternative main claim. Advantageous embodiments and developments of the invention are disclosed in the dependent claims, the description and the figures. 
     In the positioning device according to the invention for arranging and orienting a plurality of fastening devices on a base layer of a main body of an orthopedic device, comprising a first holder having at least one receiving device for a fastening element, and a second holder having at least one receiving device for a fastening element, provision is made that the first holder and the second holder are mounted on each other so as to be pivotable about a pivot axis about a limited angle range proceeding from a starting position. By arranging the fastening elements on the holders that are mounted pivotably relative to each other, it is possible to modify the orientation and positioning of the fastening elements relative to each other on the respective holders, wherein the modification takes place within a pivoting range within which components can be fastened without difficulty to the orthopedic device via the fastening elements. For example, drives, guides, joints or dampers, which have only a limited angle tolerance, can thus be easily positioned on the base layer of the main body before the production thereof, such that, after the production of the orthopedic device or of the main body of the orthopedic device, no further intermediate pieces, tolerance-compensating means or adapters need to be provided in order to be able to secure the component to the respective fastening element. By way of the positioning device, the fastening elements are arranged on the base layer in the defined positions relative to each other, wherein the fastening elements can 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 to the main body, such as dampers, joint devices, drives, controls or the like. A form-fit element is also understood as a screw or a threaded rod. By arranging the fastening elements in the 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 arrange them on the base layer and secure them to the main body. 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 orthosis 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. In addition, the precision of the arrangement of the fastening elements on the main body is increased. 
     Each holder of the positioning device can have a plurality of receiving devices for in each case one fastening element, such that, for example, two or more fastening elements can be positioned in a defined allocation to each other on a distal component of the orthopedic device, and a plurality of fastening elements, for example three fastening elements, can likewise be oriented in a defined allocation to each other on the base layer of the main body on a proximal component of the orthopedic device. If a plurality of fastening elements are arranged on the orthosis components, the respective additional device such as actuator, damper or joint can be fastened in a rotationally rigid manner. 
     The receiving devices can have bearing surfaces for the respective fastening element, which bearing surfaces lie on a holder in a common plane. This ensures that all the fastening elements on a holder lie in a common plane or at a common level and can be tilted only together with the holder relative to the other holder and therefore to the arrangement plane of the other fastening elements. The configuration of bearing surfaces in one plane on a holder, for a uniform orientation of the fastening elements located thereon, facilitates standardization of the additional components such as joint devices, actuators or dampers, and also the production. It is also possible in principle to arrange all the fastening elements on a holder at different levels or in different planes, wherein the planes are preferably oriented parallel to each other, although they can also be tilted relative to each other. However, the arrangement in one plane facilitates both the production of the positioning device and the mounting of the fastening elements and of the structural parts to be secured thereon. 
     The receiving devices can be configured as sleeves, so as to be able to receive the fastening elements which, for example, have pegs, inner threads, shafts or similar from-fit elements or devices for securing the further components. The sleeves are preferably cylindrical, although other shapes, in particular oval or angular shapes, can also be provided in principle. 
     In a development of the invention, the holders are mounted pivotably on a central piece. This central piece serves for the independent pivoting of the holders relative to each other. It is thus possible to pivot one holder, for example a distal holder, independently of the other holder, a proximal holder, relative to the central piece. By way of the central piece, a basic orientation of the positioning device on the respective main body can be obtained, such that a relative movement of the holders with respect to the central piece and to each other about the pivot axis is possible within the respectively predefined, limited angle range. The pivot axis for the first and second holder is configured on the central piece. The holders can advantageously be fixed on the central piece once a position has been found. This can be done, for example, by clamping the holder on the central piece. The holders are preferably steplessly pivotable within the angle range and can be fixed on the central body in each position relative to each other and to the central body. 
     To be able to orient the positioning device on the main body and optionally secure it, a fixing device for orienting the whole positioning device on the main body can be arranged on the central piece. The fixing device can be a peg, a thread or another preferably form-fit or force-fit securing device. It is also possible in principle that the central piece and therefore the positioning device can be fixed on or at the main body via a force-fit fixing device, for example a magnet device or a combination of several magnet devices on the central piece. 
     In a development of the invention, the fixing device is configured such that the pivot axis of the two holders is oriented orthogonally with respect to a joint axis of a joint device that can be arranged on the main body. The joint device has a joint axis which aligns with the physiological joint axis and is correspondingly configured and oriented, in the best case coinciding with the physiological joint axis. The joint device is for example a prosthesis joint or an orthosis joint. If the pivot axis of the positioning device is coincident with the joint axis of the joint device, the pivotability of the holders relative to each other about the pivot axis permits individual customization to the respective main body or to a respective patient or to the respective device. For example, if the main body is an orthosis or a preliminary stage to an orthosis, the main body can be adapted to the individual body shape of the patient. If the base layer is arranged, for example, on a proximal and distal limb so as to span a joint, for example on the thigh and the lower leg of a patient, the different anatomical circumstances result in a large number of possible orientations of orthosis components proximally and distally from the natural joint axis. The longitudinal axis of the fixing device symbolizes or then corresponds to the joint axis of the joint device that is intended to be fastened later to the main body. The limited angle range on the positioning device about which the holders can be pivoted reflects the manufacturing tolerances or assembly tolerances of the joint devices, such that the assembly tolerances of the respective joint device can already be taken into consideration in the production of the main body. 
     An abutment element can be arranged on the central piece and, with a mating piece arranged on the respective holder, limits the angle range. The angle range about which the holders are pivotable about the pivot axis is thus adjustable or modifiable, for example to be able to take into consideration different assembly tolerances in the respectively provided component or the components. If angle-tolerant joint devices, actuators or dampers are used, the angle range chosen can be greater; if components are provided that are sensitive with respect to the tilting of the bearing points, the limited angle range can be made smaller and reduced to the respectively admissible extent. 
     The abutment element and/or the mating piece can be arranged adjustably on the central piece or the holder. An abutment element or a mating piece can be provided for each holder, such that an individual setting of the respective holder is possible by adjusting the abutment element or the mating piece. It is likewise possible that only one abutment element is provided, via which both holders are modifiable in terms of their adjustment range. 
     In a variant of the invention, provision is made that the abutment element is arranged on the central piece so as to be displaceable along the pivot axis and securable in the respectively desired position. By virtue of the displaceable arrangement of the abutment element along the pivot axis, it is possible, after arranging the central piece on the main body and optionally fixing it on the main body, to first of all position a holder and the fastening elements arranged thereon on the base layer of the main body. The holder is fixed in the position then found. The position of one holder limits the displacement path of the abutment element and defines the attainable maximum position of the abutment element with respect to the other holder. The remaining adjustment range or pivoting range of the other holder relative to the first holder is thus defined via the position of the abutment element on the central piece. When a setting of the holders for optimal orientation of the fastening elements on or at the main body is found within the maximum angle range, the holders are fixed on the central piece. The fastening elements are then secured on the base layer, for example by an adhesive, a filler compound, a compensating compound or via adapters. The positioning device thus affords the possibility or permitting an optimized arrangement of the fastening elements on the base layer, for example of a prosthesis or orthosis or of another orthopedic device, across a fixed tolerance range of the angle orientations of the fastening elements relative to each other. The maximum range of angle adjustment about the pivot axis is limited structurally. The abutment element produces a coupling between the holders, in such a way that the pivoting of one holder about a pivot angle is subtracted from the possible pivot angle of the other holder in the opposite direction. If, proceeding from the starting position, both holders have available a pivoting range of +−5° and if the first holder is pivoted upward about 3° in the case of a horizontal pivot axis, the other holder has available a pivoting range of 2° upward and 8° downward. With the positioning device arranged laterally on a support, this would mean, on the first holder, a pivoting in the lateral direction of 3°, which for the second holder would mean a maximum pivoting about 2° in the lateral direction or 8° in the medial direction. 
     If compensating measures have to be taken despite the pivoting of the holders within the maximum permissible angle range, for example because the allocation of an orthosis component for a thigh to an orthosis component for a lower leg does not permit a complete and optimized contact on the base layer, the free space is filled in, for example by an adhesive or a filler compound. The orthopedic device is then produced after the fastening elements have been fixed to the base layer and, if appropriate, after placement of further covering layers, in particular made of fiber-reinforced composite materials. The positioning device no longer needs to be coupled or connected to the fastening elements; instead the main body can be fed together with the fastening elements to the further necessary processing steps, for example cured at high temperatures and in a vacuum. The absence of the positioning device, which is preferably made of a metallic material, permits production that is free from differences in thermal elongation, such that more precise production of the orthopedic device can take place. 
     The abutment element and/or the mating piece can have bearing surfaces which are oriented obliquely or curved with respect to the pivot axis. By means of the oblique or curved bearing surfaces, it is possible to achieve stepless adaptation of the respective pivoting ranges or angle ranges through which the holders are pivotable about the pivot axis. If the abutment element is mounted displaceably, the oblique or curved bearing surfaces cause a force component to be exerted in the displacement direction in the event of a rotation of one holder relative to the other holder. If the first holder is pivoted to the maximum extent from the starting position, the abutment element is displaced by the mating piece of the first holder in the direction of the opposite mating piece and thereby limits the possible pivoting angle thereof, if appropriate to zero. 
     In a development of the invention, provision is made that the respective abutment element and the respective mating piece have correspondingly configured bearing surfaces oriented toward each other, in particular oriented in a wedge shape, such that, when an end position of the abutment element is reached, a basic position for the respective holder relative to the central piece is reached and defined, while for the other holder a maximum pivotability about the pivot axis in both pivoting directions is possible. When the abutment element is located in a central position, both holders are mounted pivotably in both directions about the pivot axis relative to the central piece. The angle range of the pivoting per holder is then accordingly halved. This is especially the case when about the abutment element has at mutually opposite ends in each case a wedge-shaped end region or an end region oriented toward each other, which is assigned to a respective correspondingly shaped mating piece. In a symmetrical embodiment of the abutment element, different pivoting ranges can be assigned to one holder or the other depending on the position of the abutment element. 
     The holders can be mounted on each other so as to be pivotable in an angle range of +−10° about the starting position, wherein the angle ranges can be different for each holder. Thus, one holder can have an angle range of +−10°, while the other holder has a pivoting and an angle range of +−5° about the starting position. This is defined by the design of abutment element and mating piece. 
     In a development of the invention, provision is made that the receiving devices for the fastening elements have, in the starting position of the holders, a longitudinal extent oriented parallel to each other. This ensures that, for example in joint devices, the fastening to the fastening elements can take place in an axially parallel manner, such that, in the production of the joint device, the bores, sleeves or receptacles can also be easily produced in an axially parallel manner. 
     In a system formed of a positioning device, as described above, and of a main body of an orthopedic device, provision is made that the main body, spanning a natural joint of a limb, is designed to bear integrally on the limb. The orthopedic device is preferably designed as an orthosis or prosthesis. If the main body is designed spanning a natural joint of a limb and bearing integrally on the limb, this also entails that a notional limb can be used in the case of a missing distal limb. The missing limb can then be modeled, for example by optical recording of a limb stump, processed in 3D simulation and then produced by a 3D printing method. After the fastening elements have been positioned on the main body and after the fastening elements have been fixed to the main body both on the proximal and also the distal side of the joint axis of a natural joint, production then takes place in common. During and after the production, the fastening elements maintain the positions, orientations and distances predefined by the positioning device. The main body can then be divided into a distal and a proximal component. In an embodiment as an orthosis, one then has a distal orthosis shell and a proximal orthosis shell; in a prosthesis one has a prosthesis socket, for receiving a stump, and a prosthesis component which is fixed to the prosthesis socket via a joint device or another fastening device which is secured to the fastening elements. 
     A receptacle for fixing the positioning device can be arranged on the main body. The receptacle can be a form-fit or force-fit receptacle. For example, a locking nut or a locking screw can be secured in the main body or on the main body in order to fix the positioning device there. Alternatively, this can be effected by a magnetic coupling. The receptacle can also be arranged on or in a support onto which the base layer of the main body is applied and formed. The receptacle does not have to be connected non-releasably to the base layer; a stable geometrical assignment is sufficient, with the fixing device oriented preferably along the joint axis, such that the pivot axis can be oriented orthogonally with respect to the joint axis. 
     The receptacle can be arranged in the region of the joint axis of the natural joint of the limb on which the orthopedic device, in particular the orthosis or prosthesis, can be arranged. If the longitudinal extent of the receptacle is coincident with the pivot axis of the holders, this can be easily realized by a plug connection or screw connection. The positioning device is then plugged onto the receptacle or screwed into the receptacle. In the case of a magnetic orientation, the orientation of the positioning device is effected via the orientation of the magnets and of the ferromagnetic elements as mating piece. 
     The main body can be molded on a model of the limb or on the limb itself and can have an inner contour corresponding to the contour of the limb. The respective fastening element is placed on the base layer of the main body, secured, optionally covered with one or more covering layers, and then finalized. 
     On the main body, a predetermined separation region or a predetermined separation point can be formed along which the main body can be divided into a proximal component and a distal component. The predetermined separation region can be formed by material weakening or by the omission of fiber composite material layers in this region. The predetermined separation region then contains only the base layer, which can also be composed of a plurality of layers of a fiber composite material. 
     An illustrative embodiment of the invention is explained in more detail below with reference to the attached figures, in which: An illustrative embodiment of the invention is explained in more detail below with reference to the attached figures, in which: 
       FIGS. 1 a  to 1 d    show views of a fastening element; 
       FIG. 2  shows a schematic perspective view of a support with an applied base layer; 
       FIG. 3  shows a base layer according to  FIG. 2  with attached fastening elements; 
       FIG. 4  shows a schematic side view with an applied fiber composite material layer; 
       FIG. 5  shows a sectional view according to  FIG. 2 ; 
       FIG. 6  shows a sectional view according to  FIG. 3 ; 
       FIG. 7  shows a sectional view according to  FIG. 4 ; 
       FIG. 8  shows a view of a finished orthosis; 
       FIG. 9  shows a positioning device for the fastening elements; 
       FIG. 10  shows the positioning device according to  FIG. 9  in a bottom view; 
       FIG. 11  shows an exploded view of the positioning device; 
       FIGS. 12 and 13  show views of holders at different angle positions; 
       FIGS. 14 and 15  show sectional views of  FIGS. 12 and 13 ; and 
       FIG. 16  shows a variant of the central piece. 
    
    
       FIGS. 1 a  to 1 d    show different views of a fastening element  10 , wherein  FIG. 1 a    shows a perspective overall view,  FIG. 1 b    shows a side view,  FIG. 1 c    shows a bottom view, and  FIG. 1 d    shows a further side view. The fastening element  10  has a base  11  which, in the illustrative embodiment shown, is substantially flat and plate-shaped. Bevels are formed at the edges of the base  11  in order to provide improved contact to a substrate or a support surface in order to form a smooth transition. In addition, connecting material or an adhesive can be arranged between the bevels and fiber composite materials in order to fix the fastening element  10  thereon. The base  11  is non-round and has two flattened regions  16  at mutually opposite sides. Between the flattened regions  16 , the base  11  forms a radius, the continuation of which would lead to a circle shape. The contour of the base  11  thus corresponds to a circle with cut-off circle segments with parallel chords. A central bore with a form-fit element  12  in the form of an inner thread is formed in the middle of the base  11 . The inner thread  12  extends along the longitudinal extent of a shaft  13 , which protrudes from the base  11 . A binding surface  14 , which is substantially plane, is formed on the side of the shaft  13  remote from the base  11 . Lying opposite the binding surface  14 , a bottom surface  15  is formed on the base  11 ; the binding surface  11  and the bottom surface  15  are oriented substantially parallel to each other. The shaft  13  is rotationally symmetrical, and the central bore with the inner thread  12  is formed coaxially with respect to the longitudinal extent of the shaft  13 . The shaft  13  is stepped in the front third directed toward the binding surface  10 , that is to say the shaft  13  there has a smaller diameter than in the region of the base  11 . The size of the shoulder can vary. In particular, the shoulder is chosen such that layers of a fiber composite material applied to the base  11  reach 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 shaft  13  can 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 base  11 . 
     Recesses, projections or undercuts can also be arranged or formed on the fastening element  10 , in order to provide further securing to a base layer for producing a main body for an orthopedic device. The use of the fastening element  10  in connection with the production of orthopedic devices such as orthoses, prostheses or other orthopedic components is explained below. The base  11  serves to secure the fastening element  10  on a main body, while the form-fit element  12  serves to ensure that further components of an orthopedic device can be secured to the fastening element  10 , 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 to  FIGS. 2 to 4 . 
       FIG. 2  shows a schematic view of a support  1  which is shaped corresponding to the body part on which an orthosis or prosthesis is intended to be worn. In the illustrative embodiment shown, the support  1  is 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 support  1  in any other form that is required in order to form an orthosis. If a prosthesis is to be produced, the support  1  can 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 layer  2 , which is formed from one or more blanks, is applied to the support  1 . The base layer  2  is 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 layer  2  is formed in one piece and extends over a joint axis  3  of a natural or assumed joint of the respective limb. In the illustrative embodiment shown with the support  1  as a thigh part, the base layer  2  covers the knee-joint axis  3 . The base layer  2  is sufficiently flexible to be able to conform to the surface structure of the support  1 . The support  1  can 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 layer  2  is of a closed configuration, i.e. not open for the passage of components such as fastening elements  10  that are applied to the base layer  2 . The base layer  2  can be fixed to the support  1  either mechanically or by an adhesive. The fixing is done in such a way that the base layer  2  is removable again after the orthosis or prosthesis has been produced. 
       FIG. 3  shows a next phase in the production of the orthosis components, in which phase fastening elements  10 , as have already been described with reference to  FIG. 1 , are placed on the lateral surface of the base layer  2 , i.e. on the surface facing away from the support  1 . The fastening elements  10  are applied via the underside  15 , i.e. the surface of the base  11  facing away from the bearing surface  14  The fastening elements  10 , in the illustrative embodiment five fastening elements  10 , of which two are positioned in the distal region and three in the proximal region, are positioned on the base layer  2  preferably via a positioning device. The positioning device is explained in more detail further below. By means of the positioning device, the fastening elements  10  are arranged on the base layer  2  at defined spacings from each other and from the joint axis  3 . The positioning device is secured to or placed on a receptacle  4 , for example plugged on, screwed on or fixed via a magnetic lock. The receptacle  4  is preferably already arranged on the support  1  and protrudes through a recess in the blank of the base layer  2 . The receptacle  4  can be worked into the support  1 , 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 receptacle  4  should 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 elements  10  are fixed on the base layer  2 , 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 elements  10  or tilting of the fastening elements  10 . 
     After all of the fastening elements  10  are fastened on the base layer  2 , the positioning device is removed, as will be explained later. The fastening elements  10  and also the receiving device  4  remain securely on the outer or lateral surface of the base layer  2 . 
     At least one layer  8  of a fiber composite material with punched-out recesses is then placed over the shafts of the fastening elements  10 , wherein the recesses in the layer  8  of a fiber composite material are dimensioned such that the respective shaft can pass through, but not the base  11 . In this way, the base  11  of the fastening element  10  is embedded between the base layer and an outer composite fiber material layer  8 . Predetermined separation lines  6 , along which separation can take place easily or more easily, can be worked into the outer fiber composite material layer  8 . In the illustrative embodiment shown, two predetermined separation lines  6  form a predetermined separation region in which the joint axis  3  and also the receiving device  4  lies before the anchor plate. After the separation at the predetermined separation lines  6 , a proximal component  21  and a distal component  22  of the orthosis are obtained, i.e. a thigh shell  21  and a lower-leg shell  22 , with fastening elements  10  laminated therein. The separation or removal of the predetermined separation region between the predetermined separation lines  6  is effected only after the base layer  2  together with the at least one fiber composite material layer  8  has 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 layers  8  are preferably applied as far as the shoulder in the shaft  13 . The shoulder ensures that a sufficient material thickness is present in the region of the fastening elements. A fiber composite material layer  8  as blank with pre-formed recesses  80 , which correspond in terms of diameter to the shaft diameters of the shafts  13  and in terms of their positions to the positions of the fastening elements  10  on the base layer  2 , are shown on the left in  FIG. 4 . 
     After the laminate material has cured and cooled, a main body  20  is present with a continuous base layer  2  on the inner side, fastening elements  10  placed thereon, and at least one layer, preferably several layers, of fiber composite material  8  which are connected to each other such that the fastening elements  10  are laminated in. After curing and cooling, the orthosis main body  20  is separated, for example sawn through, in the region of the predetermined separation points  6 , in order to separate the thigh shell or proximal orthosis component  21  from the lower-leg shell or distal orthosis component  22 . The orthosis components  21 ,  22  are then removed from the support  1 , 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. 5 to 7  show the production sequence in a schematic sectional view. First, the anchor plate or the receptacle  4  is positioned on the support  1 , specifically in the region of the joint axis of the natural joint or of a compromise axis  3 . The base layer  2  is then applied to the outer or lateral surface of the support  1  and optionally fixed. The material of the base layer  2  can 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 support  1 . The spacing from the support  1  is indicated in order to make matters clearer. 
       FIG. 6  shows the state after the fastening elements  10  are applied to the lateral surface of the base layer  2 . The fastening elements  10  are positioned on the base layer  2 , in a manner aligned with the joint axis  3 , via a positioning device. It will be seen that the respective bases  11  of the fastening elements  10  should be arranged as close as possible to the surface of the base layer  2 . In the illustrative embodiment shown, the connection of the respective underside  15  of the respective base  11  of the fastening elements  10  is effected via a filler compound  7 , which at the same time evens out irregularities in the surface of the base layer  2  and ensures that the fastening elements  10  are rigidly anchored on the base layer  2 . 
     It will be seen from  FIG. 6  that all of the binding surfaces  14  lie in a respective plane E 1 , E 2 , wherein the plane E 1  stands for the fastening elements  10  of the proximal component  21  and the plane E 2  stands for the fastening elements of the distal component  22 . It will be seen from  FIG. 6  that the planes E 1 , E 2  in 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 was 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 E 1 , E 2  intersect each other in the joint axis  3 , thus resulting in a common section line, which is preferably orthogonal to the joint axis  3 . It is also possible that the binding surfaces do not lie exactly in a plane E 1 , E 2 , and instead there is a certain vertical offset. It is likewise possible that the planes E 1 , E 2  do not intersect each other in the joint axis  3 , for example because a vertical offset has been established. All the binding surfaces  14  of all the fastening elements  10  of an orthosis component  21 ,  22  preferably lie on a common plane E 1 , E 2 . The longitudinal extents of all the bores, pegs or form-fit elements  12  such as inner threads or outer threads in the fastening elements  10  are 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 elements  10  on the proximal orthosis component  21  are preferably oriented parallel to each other, likewise the longitudinal extents or longitudinal axes of the fastening elements  10  on a distal orthosis component  22 . 
     After the fastening elements  10  have been secured on the base layer  2 , several layers  8  of a composite fiber material are applied, as shown in  FIG. 7 , for example resin-impregnated fiber mats, optionally with addition of further adhesives, hardeners, solvents or the like. The layers  8  of the fiber composite material or of the fiber composite materials can be applied in different orientations, in order to laminate in the bases  11  of the fastening elements  10 . For this purpose, recesses  80  or punched holes corresponding to the shape and the diameter of the respective shafts  13  are formed in the blanks of the fiber composite material layers  8 . Since the bases  11  are greater than the diameters of the shafts  13 , no fastening element  10  can be removed from the respective orthosis component  21 ,  22  after the fiber composite material layers  8  have been connected to the base layer  2 . On account of the non-round configuration of the base  11 , all of the fastening elements  10  are 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 elements  10  cannot rotate after the orthosis components  21 ,  22  have been produced. 
     The binding surfaces  14  are not all covered by a fiber composite material layer  8 , so as to ensure accessibility to the form-fit elements  12  and to ensure a defined bearing of the components that are to be mounted. In order to avoid contamination of the form-fit element  12 , it can be secured In the embodiment according to  FIG. 1 , in which the form-fit element  12  is 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 element  12  is designed as an outer thread, 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 layers  8  have been applied, the orthosis main body  20  is produced on the support  1  under vacuum and at elevated temperatures. The predetermined separation points  6  are formed proximally and distally at the joint axis  3 , for example by impressions or cuts made in the fiber composite material layers  8  or simply by applying no or fewer fiber composite material layers  8  in the region between the predetermined separation points  6 . 
     After curing and separation of the orthosis components  21 ,  22  from each other, other components can be secured to the fastening elements  10 . 
       FIG. 8  shows a variant of a knee-joint orthosis in which the proximal component  21  is designed as a thigh shell and the distal component  22  as a lower-leg shell. Fastening devices  40 , which are designed as straps, are arranged on both orthosis components  21 ,  22  in order to secure the orthosis  50  to a leg. A joint device  30  with a hydraulic actuator  35  is secured to the no longer visible fastening elements, for example via screws The joint device  30  has its pivot axis in the region of the joint axis  3  of the natural joint. The position of the joint axis  3  on the joint device  30  is made safe by the exact positioning of the fastening elements relative to the joint axis  3  of the natural joint via a positioning device. The design of the orthosis components  21 ,  22  in the form of the orthosis shells is adapted very effectively and individually to the shape of the respective orthosis user. The production of the orthosis can take place without previously arranging the joint device  30  or a hydraulic component  35  on the orthosis components  21 ,  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. 9  shows a perspective view of a positioning device  100  for positioning and aligning fastening elements  10  (not shown), which are of the kind explained for example with reference to  FIG. 1 . The positioning device  100  has a central body  200  on which two holders  110 ,  120  are arranged pivotably about a pivot axis  130 . In the illustrative embodiment shown, a first holder  110  is provided for assigning and arranging the fastening elements  10  on the proximal orthosis component  21 , while the second holder  120  is provided for the fastening elements  10  on the distal orthosis component  22 . Both holders  110 ,  120  have receiving devices  111 ,  121 , which are designed as sleeves with through-bores through which fixing elements  123  can be guided. In  FIG. 9 , the fixing elements  123  are shown only on the second holder  120 . On the receiving devices  111 ,  121 , bearing surfaces  112 ,  122  are formed for the upper face of the base  11  of the fastening elements  10 . The upper face of the base  11  is the side of the base  11  lying opposite the underside  15 . In the illustrative embodiment shown, all the bearing surfaces  112 ,  120  are arranged on a common holder  110 ,  120  in a common plane, in order to ensure that all of the fastening elements  10  lie in a common plane when they are arranged on the respective holder  110 ,  120  and are secured there by the fixing elements  123 . 
     Arranged on the central body  200  is a fixing device  240  in the form of a screw via which the central body  200  is secured to the receptacle  4  which is fixed on the support  1  or the base layer  2 . The longitudinal extent of the fixing device  240  runs perpendicular to the pivot axis  130  and preferably intersects the latter, such that the longitudinal axis of the fixing device  240  is orthogonal to the pivot axis  130 . The longitudinal extent of the fixing device  240  is preferably flush with the longitudinal axis  3  of the joint device and of the natural joint axis or the compromise axis for the natural joint. When all of the bearing surfaces  112 ,  122  are located in parallel planes or in a common plane, depending on how the planes of the bearing surfaces  112 ,  120  are arranged, the positioning device  100  is located in a starting position. From this starting position, both the first holder  110  and the second holder  120  can be pivoted through a limited angle range, for example +/−10°, about the pivot axis  130 . Joint devices  30  or also other attachment parts may be sensitive in respect of a possible angular offset of their binding sites. By means of the positioning device  100  it is possible, besides the exact positioning of the fastening elements  10  relative to each other and to a joint axis  3  about a joint device  30 , to take account of this maximum angular offset. There is the possibility of fixing the extent of the angular offset of the two holders  110 ,  120  in advance. For example, if a maximum offset of the planes of the binding surfaces  14  of 10° is admissible, this maximum angle range can be set with the positioning device  100 . If, proceeding from the starting position, the first holder  110  is then applied to the base layer  2  and requires a pivoting in the lateral direction through 3°, proceeding from the starting position, a maximum pivoting range of a further 7° in the lateral direction is available for the second holder  120 . If, with such a maximum setting, a satisfactory orientation of the undersides  15  of the bases  11  of all the fastening elements  10  is not possible, the whole positioning device  100  has to be offset further laterally, or the fastening elements  10  have to be secured to the base layer via a compensating compound or a filler compound. 
     The positioning device  100  is designed with axial symmetry.  FIG. 9  shows an upper face, for example, while  FIG. 10  shows the underside. A comparison of  FIGS. 9 and 10  shows that identical receptacles for the fastening elements  10  are formed on both sides of the receiving devices  111 ,  112 . The fixing device  240  can be removed from the central body  200  and re-inserted the other way round, such that the positioning device  100  is suitable both for a right leg and for a left leg and also for medial and also lateral positioning on base layers  2 . 
     In  FIG. 10 , the fixing elements  113  in the form of screws are shown in all of the receiving devices  111 . The inner threads  12  according to  FIG. 1  are designed corresponding to outer threads on the fixing elements  113 , so that assembly proceeds in such a way that, in each receiving device  11 , the shaft  13  is inserted with the binding surfaces in front into the bores of the sleeve-like receiving devices  111 . The fastening elements are fixed via the fixing elements  113 . It will be seen that the shape of the bearing surfaces  112  of the receiving device  111  corresponds to the shape and contour of the bases  11 , such that each fastening element is assigned and oriented in a defined manner on the respective holder  110 ,  120 . A groove-like guide for the two bases  11  of the two fastening elements  10  is provided in the second holder  120 . 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 elements  10  have been fixed inside the receiving devices  111 ,  121 , the positioning device  100  is secured with the fixing device  240  in the receptacle  4 . A central screw  150  along the pivot axis  130  keeps the two holders  110 ,  120  in a defined position relative to each other, preferably in the starting position in which all of the undersides  15  of the fastening elements  10  are oriented relative to each other in a common plane or at least in parallel planes. When the fixing by the central screw  150  is released, the two holders  110 ,  120  are able to pivot about the pivot axis  130  within the predefined angle range. 
       FIG. 11  shows an exploded view of the positioning device  100  with the central body  200 , and the fixing device  240  which is guided through a bore inside the central body  200  and orthogonally intersects the pivot axis  130 . The fixing elements  113  can be seen, likewise the two holders  110 ,  120  and the central screw  150 , which extends along the pivot axis  130 . Inside the central body  200 , an abutment element  230  is likewise mounted longitudinally displaceably in a bore  210  in the central body  200 . The bore  210  extends parallel to the pivot axis  130 . 
     Mating pieces  115 ,  120  with bearing surfaces  1153 ,  1253 , which interact with the bearing surfaces  233  at the two ends of the abutment element  230 , are arranged on the holders  110 ,  120  via three screws. The interaction is explained below. In the illustrative embodiment shown, the mating pieces  115 ,  125  are mounted in a fixed position on the respective holder  110 ,  120 . There is also the possibility, for example by means of oblong holes, to permit a rotatability of the mating pieces  115 ,  125  on the respective holder  110 ,  120 . The angle range can be set via the rotation of the mating pieces  115 ,  125 ; the maximum angle range can be increased, for example, by exchanging the mating pieces  115 ,  125 . It is likewise possible, for example by means of adjustment screws, to modify the position of the abutment surfaces  1153 ,  1253  in order to set the angle range about which the first holder  110  can be pivoted relative to the second holder  120  about the pivot axis  130 . For this purpose, adjustment screws can be screwed into or out of the recesses in the mating piece  115 ,  125 . 
       FIGS. 12 and 13  show the positioning device  100  in the same view. In  FIG. 12 , proceeding from the starting position, the second holder  120  is pivoted counterclockwise about the pivot axis  130  to a maximum extent. In  FIG. 13 , proceeding from the starting position, the first holder  110  is pivoted counterclockwise to a maximum extent. The maximum pivoting range is reached in both positions in  FIGS. 12 and 13 . Sectional views corresponding to  FIGS. 12 and 13  are shown in  FIGS. 14 and 15 . 
       FIG. 14  shows a section through the central piece  200  in the region of the abutment element  230 . In the sectional view, the abutment element  230  looks like a feather key, which is arranged displaceably inside the central piece  200 . In  FIG. 14 , a rounded end region  2330  with corresponding bearing surfaces  233  is in abutment with a correspondingly shaped bearing surface  1153  in a recess in the mating piece  115 . The mating piece  115  is connected rigidly to the first holder  110  in terms of rotation. The mating piece  115  is located in the starting position, in which the first holder  110  is correspondingly oriented. In this starting position, the abutment element  230  can be displaced to the maximum extent to the left parallel to the pivot axis  130 . In this way, the right-hand end of the abutment element  230  is brought out of the free space inside the mating piece  125  of the second holder  120 , such that the second holder  120  can move to the maximum extent in both directions. In the illustrative embodiment shown, the holder  120  was pivoted upward about the pivot axis, such that the bearing surface  1253  bears on the rounded bearing surface  233  of the right-hand end of the abutment element  230 . If both holders  110 ,  120  were located in the starting position and the abutment piece  230  were located in the middle, both holders  110 ,  120  would be able to pivot about the pivot axis  130  by the same angle until the bearing surfaces  233 ,  1153 ,  1253  came to bear on each other. The further the abutment element  230  is displaced in one direction or the other, the more the possible pivoting range of the other holder increases or decreases in the one pivoting direction or the other. If the bearing surfaces  1153 ,  1253  of the mating pieces  115 ,  125  are not of the same shape or symmetrical, different angle adjustment possibilities arise. In addition to a rounded shape of the bearing surfaces  233 ,  1153 ,  1253 , the latter can also have other shapes. 
       FIG. 15  shows the reverse position according to  FIG. 13 : the abutment element  230  has been displaced to the maximum extent to the right, as a result of which the right-hand end of the abutment element  230  lies in the recess in the mating piece  125  and thus abuts the bearing surfaces  1253 . This results in a maximum pivotability of the first holder  115  about the pivot axis  130 . 
     An alternative embodiment of the abutment element  230  is shown in  FIG. 16  in which, instead of a rounded configuration of the two end pieces  2330 , a straight, conical configuration of the end pieces  2330  and of the bearing surfaces  233  is present. A corresponding conical configuration of the bearing surfaces  1153 ,  1253  permits a large bearing surface and therefore low surface pressure. The longitudinal displaceability of the abutment element  230  permits a simple adjustment. In the abutment element  230 , an oblong hole can be formed through which a screw or a movement limiter can be inserted in order to limit the adjustment range of the holders  110 ,  120  relative to each other. The abutment element  230  can be fixed in the respectively desired position. The oblique configuration of the bearing surfaces  233 ,  1153 ,  1253  imposes a displacement of the abutment element  230  upon 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 holders  110 ,  120  are held securely in the respectively found optimal position in which the fastening elements  10  are placed onto the base layer  2 . This can be done, for example, by clamping by the central screw  115 .