PROSTHETIC COSMETICS AND SYSTEM OF PROSTHETIC COSMETICS AND PROSTHESIS

Description

[0001] The invention relates to a system comprising a prosthetic cosmetic unit and a prosthesis with a prosthetic joint comprising an upper part and a lower part pivotably mounted thereon about a pivot axis. The prosthetic cosmetic unit is particularly suitable for covering prostheses of the lower extremities, in particular for covering prosthetic legs in patients with a femoral stump. In principle, such a prosthetic cosmetic unit can also be arranged on an upper extremity, particularly in patients with an upper arm stump and a prosthetic elbow joint.

[0002] Prostheses serve as replacements for missing or no longer existing natural limbs and are primarily intended to at least partially restore missing or lost functionality. There are also purely decorative prostheses that conceal the absence of a natural limb. Prostheses with a prosthetic joint have devices for attaching the prosthetic joint to the stump, with which the upper part of the prosthetic joint is secured to the stump via a prosthetic socket. Various options exist for this. A lower part is pivotably arranged on the upper part, to which additional prosthetic components can be attached. For example, damper devices, actuators, or other prosthetic components such as lower leg tubes, prosthetic hands, or prosthetic feet can be attached.The design of these prosthetic components is primarily based on functional aspects; the materials should be as durable, resilient, and lightweight as possible. This usually results in a prosthetic's appearance being rather technical.

[0003] To approximate the external appearance of a prosthesis to that of the missing limb, so-called prosthetic cosmetics are attached to the prosthesis. These cosmetics shape the external appearance of the prosthesis. The prosthetic cosmetics can be made of various materials and can also perform technical functions, such as protection against mechanical impacts, environmental influences, and, to a limited extent, the provision of restoring forces if the cosmetics have been deformed during movement of the prosthesis. Foam is often used as the material for prosthetic cosmetics, which must be modulated according to the external contour of the limb to be replaced. An elastomer covering can be pulled over the foam to simulate a skin-like appearance.The foams are therefore coated with so-called cosmetic skins, which, after heating, must be applied to the foam base by shrinking or gluing.

[0004] WO 2010 / 054341 A1 discloses a method for manufacturing individually designed devices or prosthetic claddings, in which reference points are marked on the body. A plurality of images are taken from a variety of angles and used to capture the contour of the body. The other markings are applied and used to manufacture the cosmetic. The cosmetic can be designed as a one-piece construction or as a multi-part product that requires assembly.

[0005] US Pat. No. 5,880,964 A relates to a system and method for manufacturing a cosmetic prosthesis, in which the prosthesis is fitted to the user. The data for both the prosthetic socket and the prosthetic components are stored in a database. This data is used to calculate the dimensions of the inner surface of the cosmetic. Using CAD systems, an outer contour is created using an automatic grinding process that corresponds to the contour of the limb on the untreated side.

[0006] US Pat. No. 6,597,965 A relates to a method for producing a foam cosmetic for a prosthetic component. Based on the data of the prosthetic component, two halves of an internal cavity are calculated. A computer-controlled grinding machine cuts a portion of one half of the cavity into one side of the block and a portion of the other half into the opposite side of the block. The block is cut in half, and the opposing halves are joined together so that the block encloses the prosthetic component, and the prosthetic component is received in the joined cavity.

[0007] US Pat. No. 6,740,124 A relates to an endoprosthesis for transfemoral amputees comprising a socket, a foam-covered pylon, and a prosthetic foot. A plastic sheath is molded, heated, and stretched until it has a shape that allows the sheath to enclose the foam. The sheath is heated with hot air in areas of poor fit.

[0008] US Pat. No. 8,366,789 B1 relates to a prosthetic device with an outer surface that is a mirror image of the surface of the healthy leg. The healthy limb is scanned, and the resulting data is processed to obtain a corresponding contour. The design data of the prosthetic device is processed using rapid prototyping, and a cosmetic portion is produced. The cosmetic portion extends over the socket and the prosthetic joint.

[0009] DE 20 309 318 U1 relates to a knee area dividing adapter for detachably connecting a first cosmetic foam part, which can be slid over a knee joint of a leg prosthesis and fitted over a femoral shaft. A second cosmetic foam part is arranged around a lower leg part of the leg prosthesis. Two detachably connectable, plate-shaped adapter parts are provided, with a first adapter part being detachably connectable to the first cosmetic foam part and a second adapter part being detachably connectable to the second cosmetic foam part. The foam part completely surrounds the prosthetic joint.

[0010] US Pat. No. 5,376,127 A relates to a lightweight prosthetic cosmetic device with the contour and appearance of a human limb. The cosmetic device is arranged around a prosthetic component and is manufactured by heating and forming a prefabricated closed-cell polyethylene sheet material.

[0011] US 2007 / 0150069 A1 relates to a modularized leg prosthesis comprising a thigh module that can be attached to a thigh shaft, a lower leg module that can be attached to a lower leg tube, and a patella module that is pivotally connected to the lower leg module. The cosmetic component, obtained by attaching the modules to one another, is covered by a skin module made of a stretchable fiber.

[0012] US 2007 / 0162154 A1 relates to an orthopedic cover for a prosthetic component, comprising a hollow, substantially cylindrical base body for receiving the prosthetic component, with an opening sufficiently large to allow a prosthetic knee joint to be flexed. The width is sufficient to provide protection for the mechanical components of the prosthetic knee joint.

[0013] DE 10 2012 009 757 A1 relates to a prosthetic device and a covering for a prosthetic device, in which the outer contour of the prosthetic device is individually adjustable. A rotation module is used to rotate a lower part relative to an upper part of a first part of a prosthetic device about its longitudinal axis. This is intended to create an aesthetic covering in the rotated state.

[0014] DE 20 2007 009 077 U1 can be considered the closest prior art and relates to a leg prosthesis consisting of a lower part with a foot part attached thereto, and a thigh that is articulated to the lower leg part like a knee joint. The thigh part is provided with a silicone-based covering from the knee joint to one end of the stump, which tapers approximately snugly from the stump to the knee joint. The lower leg part is surrounded by a calf-like covering.

[0015] A common problem with state-of-the-art prosthetic cosmetics is that they do not extend beyond the joint area and therefore do not cover the relative movement between the upper and lower parts. Pure foam coverings are susceptible to soiling and, due to the material's strength and elastic properties, create resistance during joint flexion or extension. Furthermore, the foam coverings are difficult to quickly remove or put on, or change if necessary.

[0016] The object of the present invention is to provide a system comprising a prosthetic cosmetic and a prosthesis in which coverage over the joint area is possible without having to accept significant restrictions in the handling of the prosthesis.

[0017] According to the invention, this object is achieved by a system having the features of the main claim. Advantageous developments and variants of the invention are disclosed in the subclaims, the description, and the figures.

[0018] The system according to the invention comprising a prosthetic cosmetic device and a prosthesis with a prosthetic joint, which has an upper part and a lower part pivotably mounted thereon about a pivot axis, provides that the prosthetic cosmetic device has a first frame part, which has at least one fastening device for securing it to the lower part. In addition, the prosthetic cosmetic device has a second frame part, which has at least one fastening device for securing it to the upper part, wherein the two frame parts are pivotally mounted relative to one another. A rotating element, in particular in the form of a rotating adapter, is fastened to the prosthetic joint and preferably to a frame part, said rotating element being designed to be lockable or unlockable via an actuating element. The actuating element is accessible from the outside with a frame part or through a frame part.The actuating element opens or closes a locking device or a locking mechanism within the rotary adapter, so that, when fitted with a textile cover, the alignment of the cosmetic prosthesis can be changed from the outside by rotating and / or pivoting one part of the frame relative to another, in particular relative to a head region. If adjustments to the prosthesis are to be made within the cosmetic prosthesis, it is advantageously provided that at least one recess or at least one actuating element is arranged on the frame part, through which an adjustment can be made from the outside.

[0019] The rotating element can be at least partially surrounded by at least one frame part, wherein the rotating element can be actuated through the at least one frame part or with the at least one frame part. For this purpose, the rotating element is preferably attached to one of the two frame parts. In particular, the rotating element can be attached to the upper part and / or the second frame part to facilitate accessibility and secure assignment.

[0020] A further development of the invention provides that at least one of the two frame parts has a head region that is at least partially spherical or partially barrel-shaped, which is rotatably mounted in the other frame part. The prosthetic cosmetic part is intended in particular for prosthetic elbow joints or prosthetic knee joints and has a frame with spherical or partially spherical or barrel-shaped or partially barrel-shaped head regions in the joint area, so that a contour that approximates the natural appearance is provided even in a bent state. The frame parts form a substructure on which further prosthetic cosmetic components can be arranged. The respective frame part is attached to the upper or lower part of the prosthetic knee joint or mounted to other components of the prosthetic joint, so that the movement of the upper or lower part is also carried out with the respective frame part.The head region of the first frame part on the lower part is formed proximally, a head region of the second frame part is formed distally. The head region of the first frame part preferably projects proximally beyond the pivot axis. Essential functional components of the lower part or of the prosthetic components adjoining the lower part are arranged in the frame part, for example, a lower leg tube, a damper device, or an actuator. The frame leaves space for upper and lower connection means, for example, a pyramid adapter or screw connection for a lower leg tube, forearm tube, or a prosthetic socket. Such a connection offers the possibility of cosmetically bridging the joint connection and the socket.

[0021] A further development of the invention provides that a partially spherical or partially barrel-shaped head region is formed on both frame parts, i.e., on both the first frame part and the second frame part, which at least partially overlap each other in an extended position of the joint, with one head region being accommodated in the other head region. This results in at least partial double coverage of the prosthetic joint device in the extended position, so that particularly good protection of the prosthetic device can be achieved in conjunction with a natural appearance.

[0022] In a further development of the invention, it is provided that in a flexed position of the prosthetic joint, the head regions complementarily surround the prosthetic joint at least partially. In a prosthetic knee joint, the head regions are preferably arranged and dimensioned such that in a maximally flexed position, the head regions still overlap or are flush with one another. The aim is to avoid any gap that could allow access between the two frame parts to the joint device located behind them. The cover is closed at the front so that flexion is still possible. This design prevents a cosmetic cover applied over the frame parts from becoming trapped during movement of the prosthetic joint. The same applies when used with a prosthetic elbow joint.

[0023] The first frame part can be shell-like or with struts aligned in the longitudinal extension of the lower part. With a shell-like design of the first frame part, a full-surface cover is formed in the region of the shell-like cover, parallel or longitudinal to the lower part and the adjoining prosthetic device, for example, a lower leg tube or a prosthetic joint device with a mechanism, hydraulics, or an actuator, in order to provide a smooth contour and a high level of mechanical protection. The shell-like or groove-like design, which covers the front side of, for example, a lower leg tube, can simulate the contour of a natural limb and provide mechanical protection.

[0024] As an alternative to a shell-like and thus flat cover, one variant provides for at least two struts or strips to extend longitudinally of the lower part or the prosthetic components adjoining the lower part away from the head region, in order to enable fixation to the lower part or the prosthetic component. The struts or strips are advantageously formed integrally with the head part and preferably extend medially and laterally to the lower part. Thanks to this design, the first frame part is not located in areas of extreme stress, such as the knee area, so that no high forces have to be absorbed by the frame part, for example when kneeling down or leaning on something. This allows the frame part to be designed to be very lightweight.

[0025] The first frame part extends proximally beyond the pivot axis to create a natural appearance when flexed. Furthermore, the overhang provides mechanical protection for the underlying prosthetic components.

[0026] The second frame part can have at least one bridging element or at least one bridging section, wherein the bridging element or the bridging section extends towards a prosthetic socket with which the prosthesis is secured to the stump. Frequently there is a free space between the prosthetic socket and the upper part, which is bridged by a connecting piece, e.g. a tube, a rotating element or rotating adapter or the like. The connecting piece is fixed at its proximal end via a tube adapter to the prosthetic socket and at its distal end via a corresponding adapter to the upper part of the prosthetic joint. The connecting piece has a smaller diameter than the prosthetic socket, so that in the case of a cosmetic covering, in the event of flexion, a contour change occurs such that a dent forms on the upper part.To prevent this, a bridging section is formed on the frame, which can, for example, extend to the prosthetic shaft.

[0027] The bridging section can be formed on the second frame part. A bridging element is preferably attached to the second frame part and extends to the prosthetic shaft or into its immediate vicinity. It is also possible for the bridging element and / or the bridging section to be fixable to the prosthetic shaft. For this purpose, the end of the bridging element or the bridging section facing away from the frame part has a corresponding device, for example a form-fitting element or a non-positive connection device such as magnets, adhesive areas, or the like. Snap fasteners, hooks, clips, screws, or rivets can be arranged on the prosthetic shaft and on the bridging element or bridging section as form-fitting elements.

[0028] The bridging section or bridging element can be rotatably mounted on the second frame part or the prosthetic socket. The rotatable mounting enables subsequent alignment of the prosthetic cosmetics or the frame parts relative to the prosthetic socket or a cover. The rotatable mounting can be implemented using a rotary adapter that allows both rotation around the longitudinal axis of the upper part and tilting, for example, around a horizontal axis. This makes it possible to follow changes in the structure of the prosthetic knee joint. By enabling a rotary movement and a tilting movement, it is possible to enable uninterrupted rotational movement and alignment between the prosthetic socket and the joint without disrupting the adjustment of the prosthetic structure.The rotational movement and advantageously also a tilting movement restores a shift in the coaxiality of the vertical joint and the rotation axis of the rotary adapter that occurs when the prosthetic structure is changed.

[0029] A receiving device for a contour-forming molded part can be arranged on the first frame part; in particular, a foam part or a molded part made of a flat material can be attached to the lower, first frame part in order to individualize the contour of the prosthetic cosmetics via a design of the frame part.

[0030] A further development of the invention provides for the head region to be designed as a separate component that can be separately attached to the frame part. This allows for different shapes or sizes, allowing a modular construction of the respective frame parts. This increases the approximation to the natural appearance.

[0031] A textile cover is preferably pulled over the frame components to cover them. The textile cover has the advantage that no or only extremely low mechanical forces are transferred to the prosthetic joint. Complex shrink-fitting or the laborious bonding of skin-like films to a foam body is no longer necessary, as the frame construction provides a shaping substructure that only needs to be provided with a quasi-closed surface, similar to a stocking. The textile designs are diverse; a skin-colored cover similar to pantyhose can be provided, as can materials of other colors. The textile cover can be attached to the frame and / or the other prosthetic component using form-fitting elements or friction-fitting elements such as elastic bands, adhesive elements, or adhesion areas.The fastening can be made either solely to the frame or also to the prosthetic component, such as the prosthetic socket or a distal prosthetic element, such as a prosthetic hand or foot. Corresponding devices are provided on the respective prosthetic component so that the textile covering can be secured to them. If the form-fitting elements are designed as hook-and-loop fasteners, corresponding loop or hook areas are provided in the respective fastening areas.

[0032] Partial material densifications, stiffeners or reinforcements can be applied or incorporated into the textile covering in order to provide a contour-forming function and a functional component in addition to a pure surface formation.

[0033] Instead of a textile cover, other covering materials can also be used.

[0034] Alternatively or additionally, a coating made of an elastic material, such as rubber, can be applied to the inside of the frame parts to dampen or prevent vibrations that occur when using a rigid frame material and that can be transmitted to the knee joint. This can reduce or prevent noise, known as droning. A coating can protect the frame and its paintwork.

[0035] The frame part can be attached or fixed to the prosthesis or kept at a distance from the prosthesis using fixing or spacer elements. A strap or a flexible traction device can be provided as a fixing element, for example; a metal bracket with a plastic part, discs, pins, or projections, optionally also designed as elastic components, can be provided as a spacer element in order to provide sufficient volume stability or positional stability of the frame part relative to the underlying prosthetic component, for example a tube or a shaft. If the spacer element is designed as a metal bracket, it is preferably attached to the upper part and secured against rotation.

[0036] The frame parts are preferably made of dimensionally stable materials, in particular metal, fiber-reinforced plastics, thermosets or thermoplastics or of a foam material, so that in addition to the pure shaping, mechanical loads can also be absorbed.

[0037] Exemplary embodiments of the invention are explained in more detail below with reference to the accompanying figures. Like reference numerals denote like components. They show: Figures 1a to 1c show a schematic representation of a prosthetic cosmetic in different views; Figure 2 shows a schematic representation of a prosthesis with prosthetic cosmetic in side view; Figure 3 shows a variant of the Figure 2 with textile cover; Figure 4 a prosthesis according to Figure 3 without textile cover; Figure 5 a schematic view of a first frame part; Figure 6 a schematic view of a prosthesis according to Figure 5with a second frame part; Figure 7 shows a frontal view of a prosthetic cosmetic without a textile cover in the extended position; Figure 8 shows a prosthesis in a bent position in a side view; Figure 9 shows assembled frame parts in the extension position with a rotating adapter in a side view; Figure 10 shows a detailed view of the second frame part with fixing element and driver; Figure 11 shows a detailed view of the driver and holder; Figure 12 shows individual representations of spacer elements; and Figure 13 shows a perspective side view of a variant of the invention.

[0038] Figure 1ashows a schematic front view of a prosthetic cosmetic assembly 1 for a prosthesis 10, in the illustrated embodiment for a prosthetic leg with a prosthetic shaft 6 for attachment to a thigh stump (not shown). The prosthesis 10 has a prosthetic joint 2 in the form of a prosthetic knee joint, which has an upper part 3 and a lower part 4 pivotably mounted thereon about a pivot axis 5. A prosthetic foot 13 is attached to the lower part 4 on a lower leg tube 12 and forms the distal end of the prosthesis 10. Instead of a prosthetic knee joint 2 and a prosthetic foot 13, the prosthetic cosmetic assembly 1 can also be arranged and designed in an arm prosthesis; in this case, an upper arm shaft is provided instead of a thigh shaft, an elbow joint is provided instead of a prosthetic knee joint, and a prosthetic hand is provided instead of a prosthetic foot. The following explanations also apply accordingly to a prosthesis of the upper extremity.

[0039] The upper part 3 of the prosthetic knee joint 2 is connected to the femoral shaft 6 via a connecting piece 11, for example, via a rotating adapter or a tube. A cover 30, in the illustrated embodiment, a textile cover 30, is arranged on the outer side of the femoral shaft 6. This cover extends over the joint area and over the pivot axis 5 to the proximal end of the prosthetic foot 13. The cover 30 can be secured in a form-fitting or force-fitting manner to the respective prosthetic component—in the illustrated embodiment, the prosthetic shaft 6 and the prosthetic foot 13—for example, via magnets, hook-and-loop fasteners, clips, screws, rivets, or via adhesive elements or adhesion devices.

[0040] The prosthetic cosmetic 1 provides a first frame part 21, which is fixed to the lower part 4. The first frame part 21 extends proximally beyond the pivot axis 5. A second frame part 22 is arranged on the upper part 3, which in the illustrated embodiment extends distally beyond the pivot axis 5 and, in the illustrated embodiment, covers the proximal edge of the first frame part 21. A bridging section 223 extending in the proximal direction is formed on the second frame part 22, which extends in the direction of the prosthetic shaft 6 in order to achieve an approximately uniform, as seamless as possible, contour from the femoral shaft 6 to the prosthetic knee joint 2. The bridging section 223 is in the Figure 1b, which shows a side view of the prosthesis 10 without the cover 30. In addition to a single bridging section 223, several bridging sections 223 can also be arranged or formed on the second frame part 22, for example as tabs, tongues, or projections. The bridging section(s) 223 conceal the diameter difference between the outer diameter of the prosthesis shaft 6 and that of the connecting piece 11 for connecting the prosthesis shaft 6 to the prosthetic knee joint 2.

[0041] In addition to devices for connecting proximal or distal prosthetic components such as the prosthetic shaft 6 and the lower leg tube 12, the prosthetic knee joint 2 can also comprise damping elements, actuators, and mechanical or electrical and electronic control components. In the exemplary embodiment according to Figure 1b, the lower part 4 is covered with a molded part 7 that simulates the shape of a natural lower leg. The molded part 7 can be made of a foam material and covered with a covering 30, as shown in Figure 1c shown in a frontal view. The first frame part 21 can be designed to be open at the front, so that a window is formed in the region of the natural tibia head, so that when the prosthetic knee joint 2 is subjected to a frontal load, for example when kneeling, no mechanical load is applied to the first frame part 21.

[0042] Figure 2shows a side view of a variant of the invention in which the prosthetic cosmetic piece 1 is shown on a prosthetic leg in an extended position. The cover 30 is secured to the outside of the prosthetic socket 6 via a frictional connection element 32, in the present case an elastic band with an adhesive inner side. Alternatively, instead of a band 32, an area with an adhesive coating, e.g. made of silicone, can be applied to the inside of the cover 30. The prosthetic socket 6 is coupled to the prosthetic knee joint 2 via a partially shown connecting element in the form of a rotary adapter. The second frame part 22 is fastened to the upper part of the prosthetic joint 2, so that when the prosthetic socket 6 moves, the second frame part 22 is moved along.

[0043] At the distal end of the second frame part 22, a head region 221 is formed, which is partially spherical or partially barrel-shaped and thus essentially corresponds to the natural shape of a knee joint. The first frame part 21 is fixed to the lower part 4 of the prosthetic joint 2, so that upon pivoting about the pivot axis 5, the first frame part 21 moves together with the lower part 3 and the adjoining prosthetic components, for example the prosthetic foot 13 or a lower leg tube 12. One or more molded parts 7 for simulating the natural calf muscles are attached to the first frame part 21 in the posterior region. The distal end of the cover 30 is fixed to the prosthetic foot 13 via a form-fitting element 31 in the form of a hook-and-loop fastener.In principle, it is also possible to attach and fix the cover 30 to the prosthetic foot 13, the lower leg tube, or the frame part 21 using other connecting elements, for example, using the frictional locking elements described above or an area with an adhesive coating on the inside of the cover 30. The textile cover 30 extends from the femoral shaft 6 to the proximal end of the prosthetic foot 13.

[0044] In the Figure 31 shows a side view of the prosthesis 10 with a cosmetic prosthesis in conjunction with the textile cover 30. The textile cover 30 is used in combination with the two frame parts 21, 22 and allows the cover to be easily put on and taken off. Due to its textile design, the cover 30 can be easily attached to the prosthesis components 6, 13 and / or the frame parts 21, 22. If a molded part 7 is arranged on the lower part 4, the textile cover 30 can be held to the molded part 7, preferably via a silicone adhesive connection, i.e., an at least partial silicone coating on the cover 30 and / or the molded part 7. The user of the cosmetic prosthesis 1 is thus able to select and wear different designs for different occasions. A design that approximates skin color is suggested as the base color.The cover 30 can be easily pulled over the entire prosthesis 10; the cover 30 can also be open along its length and equipped with closure elements, such as a zipper or a hook-and-loop fastener. An inner coating with an elastomer or silicone prevents slipping on the surface of the prosthesis and the frame construction. Using an adapter, the textile cover 30 can also be directly attached to a foot shell, so that the textile cover can be used without a foot part and, if necessary, coupled with a sock-like cover for the prosthetic foot 13. Stiffeners 33, partial material compactions, or reinforcements are arranged on the cover, in the illustrated embodiment in the area of the knee and calf. Stiffeners or reinforcements can also be arranged within the cover 30.

[0045] Figure 4shows a side view of the design of the prosthesis 10 and prosthetic cosmetics with the cover 30. The prosthetic shaft 6 is connected to the prosthetic knee joint 2 via the connecting element 11. The second frame part 22 is fastened to the upper part 3 via fastening elements not shown. Bridging elements 222 in the form of straps, plates or tabs extend from the second frame part 22 to the prosthetic shaft 6. The bridging elements 222 are fixed in position on the prosthetic shaft 6 in a form-fitting, material-fitting or force-fitting manner. The first frame part 21 is arranged below the second frame part 22 and is fastened to the lower part 4. The fastening takes place on the one hand in the region of the pivot axis 5 and on the other hand in the distal region on the lower leg tube 12, for example by clamps or snap connections. The fastening to the lower leg tube 12 can also take place in other ways.In the distal region of the first frame part 21, a molded part 7 can be seen, which replicates the shape of the natural calf and, in the illustrated embodiment, is made of a flat material with a corresponding shape. Alternatively, the molded part 7 can also be made of a foam element, which is secured to the frame part 21 via fastening elements, for example clips, Velcro fasteners, adhesive connections, screws, rivets, generally via positive locking, or even via a magnetic fastening.

[0046] Figure 5shows a variant of the first frame part 21 in the assembled state on the lower part 4 of the prosthetic knee joint. The first frame part 21 is formed in one piece and has a hemispherical head region 211 that extends proximally over the pivot axis 5 of the prosthetic knee joint. The first frame part 21 is designed as a lightweight component and fits tightly against the lower part 4, resulting in an overall slim silhouette. Figure 5The first frame part 21 is shown in side view; the front part and the rear part of the lower part 4 are not covered by the first frame part 21. Two struts 212 extend medially and laterally from the partially spherical head region 211 to a distal clasp or bracket 216, via which further attachment to the lower part 4 is achieved. The proximal head region 211 has a recess for the connecting element 11 in the form of a rotary adapter, so that the first frame part 21 can be easily pushed onto the lower part 4 and secured thereto via a snap or clamping mechanism. In the flexed state, the wedge-shaped head region 211 essentially replicates the natural shape of the knee. Figure 5 the frontal area of the lower part 4 is free, so that no forces are introduced into the first frame part 21 when kneeling down.

[0047] Figure 6shows the second frame part 22 in connection with the first frame part according to Figure 5, wherein the second frame part 22 is fixed to the upper part 3 so that it is pivoted together with the prosthesis shaft 6 when flexed about the pivot axis 5. The first frame part 21 is indicated by dashed lines. In the extended state, the second frame part 22 covers the head region 211 of the first frame part so that during a pivoting movement the partially spherical head region 211 rotates within the second frame part 22. The gap or the tolerances between the first frame part 21 and the second frame part 22 are as small as possible so that a clamping of a cover 30 in a space between the first frame part 21 and the second frame part 22 can be ruled out. Bridging sections 223 or a bridging section 223 are formed on the second frame part 22, which extend in the direction of the prosthesis shaft 6 and form the volume between a cover 30 and the connecting piece 11, e.g.a rotating adapter or thigh tube, so that a cover 30 retains the contour of a natural limb. The second frame part 22 is preferably closed at the front. Likewise, the head region 211 of the first frame part 21 is closed at the front and has only one slot for pivoting the upper part 3 about the pivot axis 5, so that an almost completely closed contour is realized in the frontal region of the cosmetic prosthesis 1 both in the standing and bent position.

[0048] In the Figure 7A frontal view of the prosthetic cosmetic 1 is shown without a textile covering. The first frame part 21 is attached to the lower part 4 via fastening elements 9 in the form of axes for plugging, screwing, or nuts. The distal section is attached via a click fastener, a snap fastener, or other fastening means. Proximal to the pivot axis 5, the second frame part 22 is arranged in a frontally closed shape. The second frame part 22 is also pivotally mounted about the pivot axis 5 via the fastening elements 9 in the form of axes for plugging onto the prosthesis.The bridging elements 222, in the form of fabric strips, which are secured to the prosthetic shaft 6 via frictional elements 2221 in the form of a silicone or spring band or a rubber band, transmit force to the second frame part 22, so that upon flexion, both the second frame part 22 and the bridging elements 222 are moved. Instead of fabric strips, the bridging elements 222 can also be made of plastic, foam, or metal materials, which can be in strip form or a similar shape. An adapter connection for connecting the connecting piece 11 to the prosthetic shaft 6 is shown within the verification elements 222.

[0049] Figure 8shows a variant of the invention with a first frame part 21, which is designed as a full-surface, shell-like frame part 21. Proximal to the shell-like tibia part is the partially spherical head region 211, over which the distal head region 221 in a partially spherical design of the second frame part 22 is arranged, so that when the lower part is pivoted relative to the upper part, the partial domes of the head regions 211, 221 slide along one another and, in the bent-in state, form a complementary partial sphere. A rotary adapter 224 is arranged on or in the proximal end region of the second frame part 22, on which bridging elements 222 or bridging regions 223 can be arranged or formed.The rotary adapter 224 can enable a relative movement about at least one pivot axis, in particular about the longitudinal axis of the upper part 2, in order to be able to optimally position the upper frame part 22 in the event of tilting or twisting of the prosthetic socket 6 relative to the prosthetic knee joint 2. In principle, it is also possible for a rotary adapter to be present within the prosthetic device in order to enable twisting and tilting of the prosthetic socket relative to the upper part. To ensure accessibility here, cutouts 2244, bores or clearances as well as actuating elements 2241 can be provided in the second frame part 22, via which the rotary adapter 224 or the rotary adapter arranged in the prosthetic device can be reached and actuated. This makes it possible to make the respective rotary adapter 224 accessible from the outside. The actuating element 2241 serves to activate and deactivate orfor locking and unlocking the rotary adapter 224 in a prosthetic joint with mounted frame parts 21, 22.

[0050] When designing according to Figure 8 The features of the frame's self-supporting structure also become apparent. Advantages include independence from the knee joint used and the weight savings of the prosthetic knee joint.

[0051] Figure 9shows a further variant of the first frame part 21, which has a head region 211 on which an extension 2211 is formed or arranged as a separate component 2211 and fastened to the first frame part 21. The fastening can be effected by plugging, clicking on, or using screws, rivets, or other fastening elements. Advantageously, the extension 2211 can be reversibly fastened to the head region 221 on the first frame part 21. A significant advantage of such a modular solution is that it can also be used to fit long femoral stumps or knee disarticulation prostheses. The head region 211 and the extension 2211 are essentially spherical or barrel-shaped; the spherical or barrel shape here also serves primarily to shape and protect the cover from pinching.The extension 2211 arranged on the proximal edge of the head region 211 continues the partially spherical contour of the front edge of the first frame part 21 upwards and backwards. The head region 211 and the extension 2211 cover the connecting element 11 frontally, at least in the extended position, preferably also when the prosthetic joint is flexed, so that an at least approximately natural knee contour is achieved.

[0052] Figure 10shows a detailed view of the transition area from the second frame part 22 to a prosthetic socket 6 (not shown). The second frame part 22 surrounds the connecting element between the prosthetic joint and the prosthetic socket, which is designed as a rotary adapter 224 and is fastened to the prosthetic joint, at least partially. The rotary adapter is covered frontally, as well as medially and laterally, but there is access or an actuation possibility through or with the second frame part 22, so that the rotary adapter 224 is accessible from the outside for adjusting the orientation of the prosthetic socket 6 to the prosthetic knee joint or the lower part 4. Arranged within the second frame part 22 are a fixing element 225 in the form of a band, cable tie or the like and a driver 226 in the form of a bracket, via which the rotary adapter 224 can be positioned and oriented relative to the second frame part 22.When the prosthetic knee joint 2 is bent, the second frame part 22 with the upper part 3 is taken along via the driver 226 and the fixing element 225.

[0053] Figure 11 shows in a single view the components with which the second frame part 22 according to Figure 10 on the connecting element 11 or the rotary adapter 224. A fixing element 225 in the form of a band, a cable, a cable tie or a rope, which may also be elastic, is inserted into a receptacle in a holder 229 and fastened thereto. A driver 226 in the form of a metal bracket is rotatably mounted in the holder 229. The driver 226 is mounted in the upper part 3, as shown in the Figure 10shown, by inserting the ends of the driver 226 into corresponding recesses or guides within the second frame part 22. The holder 229 and thus also the driver 226 are held close to the connecting element 11 or the rotary adapter 224 via the fixing element 225. For its adjustment, the driver 226 is rotated within the upper part 22 until the driver 226 rests against the rotary adapter 224. This is achieved in that the driver 226 has an angled, crank-like shape so that a rotation of the driver 226 within the upper part 22 can cause a displacement of the holder 229. The driver 226 can be fixed in the desired position, for example by gluing, screwing or clamping.

[0054] Another possibility to ensure that the movement of the prosthetic knee joint is followed by the second frame part 22 is by the spacer elements 227 in the Figure 12 The spacer elements 227, in the form of two discs with elongated holes, can be arranged around the connecting element 11, for example in the form of a pipe section, with the elongated holes or slots being rotated relative to one another such that, in the assembled state, they can no longer be moved along the respective elongated holes. The two discs 227 complement each other in their circumference, so that when placed on top of one another, a completely closed disc is formed.

[0055] Figure 13shows a schematic representation of the prosthetic knee joint 2 with a mounted first frame part 21 and a mounted second frame part 22, which is fixed to the upper part 3, so that when the upper part 3 is pivoted with the prosthetic shaft 6 about the pivot axis 5, a relative displacement of the first frame part 21 to the second frame part 22 occurs. In the illustrated embodiment, the connecting element 11, which connects the upper joint part to the prosthetic shaft 6, is designed as a rotary adapter having an actuating element 2241 located within the second frame part 22. The actuating element 2241 is laterally covered by a flexible section 228 of the second frame part 22, so that direct access to the actuating element 2241 is not possible.To actuate the actuating element 2241, which can trigger a rotation of the upper part 3 and the prosthetic shaft 6 relative to the lower part, for example, when sitting down, the flexible section 228 is displaced toward the actuating element 2241. The flexibility of the section 228 is achieved via a slot 2280 formed within the second frame part 22, so that a displacement of the flexible section 228 is easily possible. The slot 2280 runs from a rear end of the second frame part 22 along a lateral wall, so that an inward bending of the flexible section 228 is easily possible.

[0056] If no flexible section 228 is to be or cannot be formed on the second frame part 22, an alternative recess 2244 is provided, which is formed in the region of the actuating element 2241 in the second frame part 22. The recess 2244 is in the Figure 13indicated by a dashed line. Instead of a recess that is completely surrounded by the second frame part 22, there may also be a cutout that extends from the rear edge of the second frame part 22. In the Figure 9 Accessibility is provided by a corresponding design of the first frame part 21. List of reference symbols

[0057] 1 Prosthetic cosmetic 2 Prosthetic knee joint 3 Upper part 4 Lower part 5 Pivot axis 6 Prosthetic socket 7 Molded part 8 9 Fastening element 10 Prosthesis 11 Tube 12 Lower leg tube 13 Prosthetic foot 21 First frame part 211 Head section 212 Strut 213 Strut 214 Slot 22 Second frame part 221 Head section 222 Bridging element 223 Bridging section 224 Rotating adapter 225 Fixing element 226 Driver 227 Spacer element 228 Flexible section 229 Holder 30 Textile cover 31 Form-locking element 32 Force-locking element 33 Reinforcement

Claims

1. A system consisting of a prosthesis cosmetic element according to any one of the preceding claims and a prosthesis having a prosthesis joint (2) which has an upper part (3) and a lower part (4) mounted thereon in a pivotal manner about a pivot axis (5), wherein the prosthesis cosmetic element (1) includes a first frame part (21) that includes at least one first securing means (9) for fastening to the lower part (4) and a second frame part (22) that includes at least one second securing means (225, 226) for fastening to the upper part (3) wherein the frame parts (21, 22) are pivotably supported relative to each other, characterized in that a rotational element (224) is disposed on the prosthesis joint, that rotational element (224) is fastened to one of the two frame parts (21, 22) and has an actuating element (2241) disposed thereon that is accessible from the outside.

2. The system according to claim 1, characterized in that the rotational element (224) is configured as a rotary adapter.

3. The system according to claim 1 or 2, characterized in that the rotational element (224) is at least partially surrounded by at least one frame part (21, 22), wherein the rotational element (224) can be actuated by going through the at least one frame part (21, 22) or by means of the at least one frame part (21, 22).

4. The system according to any one of the preceding claims, characterized in that the rotational element (224) is disposed on the second frame part (22) and / or on the upper part (3).

5. The system according to any one of the preceding claims, characterized in that at least one of the two frame parts (21, 22) includes a head area (211, 221) that is at least partially configured as ball-like or barrel-like and that is rotatably supported in the other frame part (21, 22).

6. The system according to claim 5, characterized in that a ball-like or partially barrel-like head area (211, 221) is configured on the first frame part (21) as well as on the second frame part (22), which overlap each another at least partially when the prosthesis joint is in the extended position (2), wherein one head area (211; 221) is received inside the other head area (221; 211).

7. The system according to claim 5 or 6, characterized in that, in a flexed position of the prosthesis joint (2), the head areas (211, 221) surround the prosthesis joint (2) at least partially, complementing each other.

8. The system according to any one of the preceding claims, characterized in that the first frame part (21) is configured as shell-like or with struts (212, 213) extending in longitudinal extension of the lower part (4).

9. The system according to any one of the preceding claims, characterized in that the first frame part (21) proximally protrudes the pivot axis (5).

10. The system according to any one of the preceding claims, characterized in that the second frame part (22) includes at least one bridging element (222) or a bridging section (223) that extends in the direction of a prosthesis socket (6).

11. The system according to claim 10, characterized in that the bridging element (222) or the bridging section (223) can be fastened to the prosthesis socket (6).

12. The system according to claim 10 or 11, characterized in that the bridging element (222) or the bridging section (223) is rotatably supported relative to the head section (221) or the prosthesis socket (6).

13. The system according to any one of the preceding claims, characterized in that a receiving means is disposed on the first frame part (215) for the contour-forming molded part (7).

14. The system according to any one of the preceding claims, characterized in that the head area (211, 221) is configured as a separate component.

15. The system according to any one of the preceding claims, characterized in that a textile cover (30) covers the frame parts (21, 22).

16. The system according to claim 15, characterized in that the textile cover (30) includes positive locking elements (31) or force fitting elements (32) by means of which the cover (30) can be fastened to a frame part (21, 22) and / or a prosthetic socket (6) and / or a foam part and / or a foot cover.

17. The system according to claim 15 or 16, characterized in that stiffeners (33) are disposed in or on the textile cover (30).

18. The system according to any one of the preceding claims, characterized in that the frame part (21, 22) includes fixation and spacer elements (225, 226) by which the frame part (21, 22) is held on the prosthesis or spaced apart from the prosthesis.

19. The system according to any one of the preceding claims, characterized in that the first frame part (21, 22) is produced from a dimensionally stable material.