PROSTHETIC SHELL

Description

[0001] The invention relates to a prosthetic socket with a base for distal connection means for attaching a prosthetic component and at least one side wall extending proximally from the base, which at least partially encloses a stump to be accommodated in the prosthetic socket. Such a prosthetic socket is particularly suitable for the treatment of amputation stumps or dysmelia, in order to provide a connection point for prosthetic components such as prosthetic knee joints, prosthetic feet, or prosthetic hands.

[0002] To ensure the most secure fit of prosthetic components to a residual limb, most prosthetic sockets are custom-made. Typically, an impression of the residual limb is taken, and a plaster positive is created from this impression. This positive is used to shape the prosthetic socket, which is usually made of plastic, or sometimes fiber-reinforced plastic. A spacer is applied to the positive to replicate an elastic liner, which is usually placed between the prosthetic socket and the residual limb, creating a gap between the outer circumference of the residual limb and the inner circumference of the socket. The prosthetic socket completely encloses the residual limb and features a proximal entry opening and a distal end, to which connectors for additional prosthetic devices are attached or integrated.These connecting devices include pyramid adapters or similar components, which are used to attach prosthetic knee joints, feet, or hands to the prosthetic socket. This manufacturing method ensures that the prosthetic socket has the individually appropriate circumference and length; adjustment of the circumference or length is neither necessary nor possible.

[0003] To adapt to fluctuations in the stump volume of the prosthesis wearer, inflatable air cushions, hook-and-loop fasteners, or a rope lacing system according to EP 2 629 705 A1 can be arranged on a prosthetic socket or a prosthetic liner. DE 10 2007 035 410 A1 relates to a prosthetic socket for receiving an amputation stump of an extremity with connecting means for a distal prosthetic device having at least one shell that has a curved, open cross-section and whose shell ends overlap each other at least partially when in place. At least one tensioning device is arranged on the shell, which is effective in the circumferential direction and clamps the shell ends against each other.

[0004] US Patent 2015 / 0265434 A1 relates to a component of a modular prosthetic stem with a flexible distal cap having a substantially closed distal end and an open proximal end. Longitudinal struts extending proximally from the distal cap are radially displaceable in elongated holes in the distal cap.

[0005] US Patent 2013 / 0289743 A1 relates to a coupling arrangement for connecting a prosthetic socket to a prosthetic liner with a magnetic device and control means to control the magnetic field by rotating the magnetic device. When the magnets are correctly aligned, a locking mechanism is created between the prosthetic socket and the prosthetic liner.

[0006] US Patent 1,272,179 A relates to an arm prosthesis with a humeral socket for receiving a humeral stump. The humeral socket has struts extending proximally from a distal end to the distal end, to which a leather socket with overlapping edges is attached. The circumference of the prosthetic socket is adjusted by means of straps.

[0007] US Patent 2,669,728 A relates to a prosthetic stem with a distal ring to which two struts extend medially and laterally in a proximal direction. The stump receptacle is attached to the struts by means of rivets.

[0008] German patent DE 9 408 556 U1 relates to a test prosthesis for a prosthetic leg with a femoral shaft and a lower leg section articulated to it. A connecting unit is arranged between the joint and the femoral shaft, which allows relative movement of the connected parts in a direction inclined to the leg axis.

[0009] US Patent 2013 / 0123940 A1 concerns a modular prosthetic socket with multiple struts aligned along the longitudinal axis of the residual limb to be supported. The struts are attached to a base to which an adapter for attaching a joint is mounted. The struts are pivotally fixed to the base.

[0010] US 2014 / 0121783 A1, from which the features of the generic term are known, relates to an adjustable prosthetic socket system comprising paddles and a compression device coupled to them. The paddles are selected such that their inner surface area has substantially the same extent as a soft tissue area lying over skeletal structures.

[0011] The object of the present invention is to provide a prosthetic socket that can be manufactured using industrially prefabricated parts.

[0012] According to the invention, this problem is solved by a prosthetic socket with the features of the main claim. Advantageous embodiments and further developments of the invention are disclosed in the dependent claims, the description, and the figures.

[0013] The prosthetic socket according to the invention, comprising a base for distal connecting means for attaching a prosthetic component to the socket and at least one side wall extending proximally from the base, which at least partially encloses a residual limb to be received in the socket, provides that at least two supports for securing the side wall are hingedly arranged on the base. By dividing the prosthetic socket according to the invention into a distal socket portion in the form of a base and a proximal socket portion in the form of at least one side wall or a side wall component, it is possible to adapt the two socket portions to one another and, in particular, to adjust the socket length.This can be achieved, for example, by shortening the supports and / or at least one side wall and reconnecting the shortened, user-adapted combination of socket components. This makes it possible to adapt a prefabricated socket to an individual residual limb length and create the desired load at the stump end, particularly with a femoral socket where support can be provided at both the ischium and the stump end. The length adjustability allows the pressure applied to the stump end to be varied, potentially increased over the course of the wearing period, or adapted to the changing conditions of the stump throughout that time. For this purpose, it is advantageous if the side wall or side wall components can be detachably and reversibly fixed at the base.Unlike custom-made products, when using prefabricated shaft components, i.e., prefabricated side walls or side wall components and the base, length adjustability is necessary.

[0014] The invention provides that at least two supports are hingedly arranged at the base, and that a side wall component is adjustable relative to each support. If several supports are arranged or formed at the base, either all supports can be hinged at the base, or at least one can be rigidly connected to the base, so that this support serves as a reference element. To adjust the prosthesis socket width and to facilitate the application of the prosthesis socket, a support with a side wall component can be folded down, thereby widening the circumference. The residual limb with the liner is then inserted into the prosthesis socket, for example, with its distal end placed against the inside of the distal base.The side wall component, which is rigidly coupled to the base, is placed against the liner, and the hinged side wall component, which is mounted on the base, is folded towards the liner to fix the residual limb and liner within the prosthetic socket. The two side wall components can overlap at their edges, so that the prosthetic socket completely encloses the residual limb. It is also possible for there to be a gap between the edges of the side wall components, provided that the shape and stability of the side wall components are sufficient to ensure secure retention of the residual limb within the prosthetic socket.

[0015] The side wall has an open cross-section, allowing for easy circumferential adjustment via a circumferentially acting adjustment system. In addition to length adjustment, width adjustment can be achieved using a clamping system that either clamps multiple side wall components against each other or allows for the adjustment of a single side wall with an open cross-section against itself, resulting in a variable overlap of the circumferentially oriented edges.

[0016] In a further development of the invention, the base and the side wall, the side walls, or the side wall components are designed such that they can be fixed or secured in different positions relative to each other. This makes it possible, for example, for one side wall to be attached to the support higher than the other side wall when viewed from the distal end of the support, so that individual adaptation to the stump can be achieved by simply sliding and fixing the side wall, the side walls, or the side wall components to the support.

[0017] A further development of the invention provides that the base is designed as a dimensionally stable cap or plate at its distal end, or has such a cap or plate, so that load-bearing distal shaft components are formed at the base, or the base has such load-bearing shaft components. The residual limb can be supported on this dimensionally stable cap or plate, and the connecting means for the distal prosthetic components can be arranged, formed, or fixed there.

[0018] The base can feature retention devices for a liner that is placed against the residual limb to form an interface between the limb and the typically rigid prosthetic socket. It is also possible for retention devices for the residual limb to be integrated into or arranged on the prosthetic socket. The retention devices for the liner can be designed as receiving elements for a pin, thus forming a so-called pinlock. It is also possible to secure the liner to the base using other positive-locking or force-locking elements. For example, magnets can be arranged on the base to fix a suitably configured liner, which also features magnets or ferromagnetic elements, to the base.It is also possible that clamping elements or clamping devices, retaining elements, or fixing devices are arranged or formed on the side wall or side wall components, by means of which the liner is fixed, clamped, fixed, or secured to the side wall along its longitudinal extent. These retaining elements on the inside of the side wall can also be designed as positive-locking elements or friction-locking elements, in particular as projections, hook-and-loop fasteners, a climbing skin, velour, or magnets. Combinations of positive-locking elements and friction-locking elements can also be arranged or formed both at the base and on the side wall or side wall components.

[0019] A further development of the invention provides that the side wall is positively locked to the base. The side wall or side wall components can be screwed to the base, fixed via locking elements, a bayonet fitting, or positive locking elements in the form of clips or other locking devices. The side wall can also be riveted to the base. Alternatively or additionally, the side wall can be clamped to the base or support to allow stepless adjustment of the side wall's position relative to the base.

[0020] The side wall can be formed from several side wall components and include a tensioning device by which the side wall components can be aligned relative to each other or tensioned against each other. Alternatively or additionally, two or more side walls can be formed, which can be aligned relative to each other or tensioned against each other by means of at least one tensioning device. The tensioning device can be designed as a strap that is fixed to both side wall components and allows for width adjustment of the two or more side wall components relative to each other by changing its length. It is also possible, in principle, for the side wall components to be mounted so that they can slide relative to each other at the base, in order to allow adaptation to different stump sizes.The supports can be arranged opposite each other, for example on the medial and lateral sides, although it is generally possible and intended that the supports are arranged in other positions, e.g. anterior and posterior. In In one embodiment of the invention, it is provided that at least one support is arranged on the medial side.

[0021] The support or supports can be designed as a rail extending proximally from the base. Preferably, the rails are shorter than the side wall or side wall components and can be shortened to achieve a shorter overall shaft length.

[0022] InThe support, particularly in the rail, can be equipped with devices for the positive locking of the side wall. These devices are specifically designed at discrete intervals to facilitate alignment at discrete distances. Alternatively, a sliding bearing with a clamping bracket can be provided either on the support or on the side wall via a slotted design. In addition to a relatively coarse grid of holes aligned with each other, allowing for length adjustment at appropriately large intervals, a fine grid can be provided on the support. This fine grid engages with corresponding projections on the side wall or side wall components, enabling precise length adjustment.

[0023] The side wall or side wall component can have guides or receptacles into which the carrier can be inserted. If the carrier is designed as a rail, the guides are configured as rail receptacles that allow longitudinal displacement and insertion from the outside, resulting in a total of three longitudinal degrees of freedom. By appropriately designing the rail receptacle or carrier receptacle, displacement can be limited to the longitudinal extent of the carrier or rail receptacle, for example, by a trapezoidal design of the rail or by a closed guide in the form of a bushing. The guides and the carrier are preferably of the same length, so that when the carrier is fully inserted into the guide, the guide is completely filled. To shorten the shaft length, both components must then be shortened equally.

[0024] Markings or material weakenings may be arranged or formed on the side wall and / or the support, creating predetermined breaking lines, predetermined cutting lines, or separation lines on the support and / or the side wall or side wall component. Particularly in the case of the supports, such a marking or material weakening is arranged in the proximal area; in the case of the side wall or side wall components, it is arranged particularly in the distal area to facilitate shortening and length adjustment. The markings or material weakenings are preferably formed circumferentially or at least transversely to the longitudinal extent of the respective component.

[0025] The side wall or side walls can be designed with different material stiffness and / or different material thicknesses. The at least one side wall need not consist of a single, homogeneous material of a constant thickness; rather, in one embodiment of the invention, different materials are combined, different material thicknesses are present in a side wall or side wall component, and / or materials are treated differently in certain areas to achieve different properties, particularly stiffnesses. For example, the side walls can be rigid in the area of ​​the support, while the remaining areas can be elastic or equipped with flexible sections.

[0026] At least two supports can be arranged and formed at the base, one medially and one laterally oriented at the base, thus providing good lateral guidance. The medial-lateral arrangement of the supports does not, or only minimally, impair the wearing comfort of the prosthetic socket, as the rigid supports, which can be made of steel or aluminum, for example, do not cause any noticeable pressure on the proximal edge of the prosthetic socket against the ischium when sitting or standing.

[0027] Exemplary embodiments of the invention are explained in more detail below with reference to the accompanying figures. These show: Figure 1 - the exploded view; Figure 2 - a schematic side view in the unassembled state; and Figure 3 - a prosthetic socket in the fully assembled state.

[0028] Figure 1Figure 1 shows an exploded view of a prosthetic socket 1 with a base 10 to which two side wall components 21, 22 are detachably attached. In the assembled and applied state, the two side wall components 21, 22 completely surround the residual limb (not shown) and form a side wall 20 enclosing the residual limb. In an alternative embodiment, the side wall 20 can also be formed in one piece and have either a closed or an open cross-section.

[0029] In the illustrated embodiment, the base 10 has a dimensionally stable cap 11 at its distal end. Connecting means (not shown) for a further prosthetic component, such as a prosthetic knee joint, can be attached to the distal side of this cap. This dimensionally stable cap 11 serves as a support for the residual limb end (not shown) and has at least one retaining device 14 for securing the residual limb or a liner attached to a residual limb to the prosthetic socket 1. In the illustrated embodiment, this retaining device 14 is designed as a hook-and-loop fastener. In an alternative embodiment, other positive locking devices or a magnetic locking mechanism can be incorporated to secure the distal end of the liner to the base 10 and thus to the prosthetic socket via corresponding positive locking elements or ferromagnetic components.

[0030] Extending proximally from the rigid cap 10 are two supports 40, designed as rails. When the prosthetic socket 1 is in place, the supports 40 are positioned on the medial and lateral sides of the residual limb and can be of equal or different lengths, with the lateral support preferably being longer. Through-holes 45 are arranged within the rail-like supports 40 as positive-locking elements for securing the sidewall components 21, 22. The through-holes 45 can be threaded and are arranged at a defined distance from one another along the longitudinal extension of the supports 40. The laterally arranged support 40 is hinged to the base 10 via a hinge 13, while the medial support 40 is integrally formed with the distal cap 41, thus creating an L-shaped, rigid base body.In addition to a pivotable mounting of the medial support 40, it can also be slidably arranged at the base 10 to allow adjustment of the stump width in the distal region. According to the invention, both supports 40 are designed to be foldable. Furthermore, more than two supports 40 can be formed or arranged at the base.

[0031] The side wall components 21, 22, and thus the entire side wall 20, are detachably attached to the base 10. For this purpose, guides 23, 24 for the supports 40 are attached to the outer surfaces of the side wall components 21, 22. The guides 23, 24 are designed as rail receptacles that correspond to the rail-like features of the supports 40 and can accommodate them. The guides 23, 24 can be C-shaped, with the cross-section of the guides 23, 24 either allowing lateral insertion of the supports 40 or having opposing flanges, so that the respective supports 40 can only be inserted longitudinally into the corresponding guide 23, 24.The side walls of the guide 23, 24 can also be inclined towards each other, so that the supports 40 are fixed in both the medial and lateral directions, but are still guided in the guides 23, 24 in a slidable manner in the longitudinal extension of the supports 40.

[0032] Corresponding to the through holes 45 in the supports 40, the guides 23, 24 have bores with internal threads 25, arranged one behind the other at intervals along the longitudinal axis, aligning with the through holes 45. The side wall components 21, 22 are connected to the respective supports 40 by means of positive locking elements 42 in the form of screws. For this purpose, the supports 40 are inserted into the guides 23, 24 until the desired length is reached. The through holes 45 and the internal threads 25 within the guides 23, 24 are aligned with each other, and the screws 42 are inserted and tightened. This achieves a positive locking, releasable connection of the side wall 20 to the base 10. The through holes 45 can also be designed as elongated holes to allow a quasi-stepless adjustment of the position of the side wall components 21, 22 relative to the base 10.It can also be formed as an elongated hole extending over the entire length, so that in addition to a positive locking fixation of the side wall 20 to the supports 40, the longitudinal displacement along the guides 23, 24 is blocked by clamping via the screws 42 and a washer 43.

[0033] In the distal region of the sidewall components 21, 22, markings 26 and material weakenings 27 are arranged transversely to the longitudinal extent to allow for shortening of the overall length if necessary. The material weakenings 27 can extend over the entire circumference of the sidewall component 21, 22, or completely over the entire circumference in the case of a one-piece design of the sidewall 20. The markings 26 are preferably oriented at regular intervals and can also be provided with a scale to facilitate length adjustment. Corresponding markings 46 and material weakenings 47 are arranged on the supports 40, preferably at their proximal ends, and allow for individual adjustment of the length of the entire prosthetic stem 1.

[0034] The sidewall components 20 and 21 form a proximal shaft portion as sidewall 20, while the base 10 with the supports 40 forms a distal shaft portion. These components are designed and arranged to be longitudinally displaceable relative to each other and fixed in position, allowing for either stepless or stepless adjustment and fixability. By shortening the distal shaft portion in the form of the base 10 and / or the proximal shaft portion in the form of the sidewall 20, the shaft length can be reduced. This makes it possible to use industrially prefabricated shaft sections to adapt a prefabricated shaft to individual stump lengths. The desired load on the stump end can also be adjusted and set.

[0035] A clamping device 50 is arranged on the lateral side wall component 21, allowing the shaft width to be varied, for example, via a cord-cable strap system. Due to the two-part design of the side wall 20 in the illustrated embodiment, as well as the hinged mounting of the lateral side wall component 21 on the base 10, it is possible and necessary to fix the position of the side wall components 21 and 22 relative to each other in the circumferential direction. The hinged base 10 and the resulting expansion of the prosthetic socket 1 facilitate entry into the prosthetic socket. This also makes it possible to arrange or form positive locking elements 28 on the inside of the side wall, which impede or prevent movement in the proximal direction.Thus, a hook-and-loop fastener, a climbing skin, or a surface texture can be arranged or formed on the inside of the side wall 20, which engages in a form-fitting manner with a corresponding structure on the liner. The opening movement allows for peeling off or disengaging, so that a corresponding separation of the prosthetic socket 1 and the liner is easily possible.

[0036] In the illustrated embodiment of the Figure 1The sidewall components 21 and 22 are designed differently. The medial sidewall component 22 extends over more than half of the total circumference, in this case 3 / 4 of the total circumference, while the lateral sidewall component 21 is dimensioned to provide additional circumference, allowing the prosthetic stump to be fully enclosed. The side edges of the sidewall components 21 and 22 can overlap each other when applied and fixed in position, thus enabling width adjustment even during wear if stump volume fluctuates.

[0037] A prosthetic socket 1 with base 10 and side wall 20 before assembly is in the Figure 2The figure shows that distal connection means 15 for a prosthetic component, for example in the form of a prosthetic knee joint, are arranged at the distal end of the base 10. The distal connection means 15 is designed as a receptacle for a pyramid adapter.

[0038] The side wall 20 is completely enclosed by the tensioning device 50. The tensioning device 50 is designed as a so-called disc system, in which a belt system or cable system 51 can be tensioned and released by turning a wheel. The width can be adjusted by tensioning the belt system or cable system 51.

[0039] To mount the side wall 20 to the base, the supports 40 are inserted into the guides. In the illustrated embodiment, due to the side view from the lateral direction, only one guide 24 and one support 40 designed as a rail are visible. Once the desired position is reached, the screws 42 are screwed through the through holes 45 and into the threads 25 in the guides 23, 24.

[0040] A fully assembled prosthetic socket 1 is in the Figure 3The distal, dimensionally stable cap 11, the hinge mechanism 13 for the lateral support 40, and the side wall 20, consisting of a lateral side wall component 21 and a medial side wall component 22, are shown. In the illustrated embodiment, the clamping device 50 has two rotary mechanisms by which the effective length of two cables 51 can be changed. The cables or bands 51 are arranged on the opposite lateral edges of the medial side wall component 22 and, by shortening them, reduce the circumference. By rotating the clamping devices 50 in opposite directions, the circumference of the prosthesis stem can be increased. The lateral side wall component 21 is detachably fixed to the base 10 by a total of four screws 42. The screws 42 are guided through the through-holes 45 in the support 40 and screwed into the internal threads 25 within the guide 23.The washer 43 provides an additional clamping effect.

Claims

1. A prosthetic socket (1), comprising a base (10) for distal connection means for attaching a prosthesis component to the prosthetic socket (1) and comprising at least one side wall (20), which extends from the base (10) in the proximal direction and at least partially extends around a stump to be held in the prosthetic socket (1), wherein at least two supports (40) for fastening the side wall (20) to the base (10) are foldably arranged on the base (10) and each sidewall component (21, 22) is mounted on the respective support (40) in such a way that it can be adjusted relative to the other, characterized in that the side wall (20) is designed as a cross-section open in the peripheral direction, with edge regions overlapping with each other..

2. The prosthetic socket according to claim 1, characterized in that the at least one side wall (20) or the side walls (20) can be fastened to the base (10) in different positions.

3. The prosthetic socket according to claim 1 or 2, characterized in that the base (10) has a dimensionally stable cap (11) or plate at the distal end thereof.

4. The prosthetic socket according to one of the preceding claims, characterized in that at least one retaining device (14) for a liner or a stump is arranged on the base (10).

5. The prosthetic socket according to claim 4, characterized in that the retaining device (14) is designed as a magnet.

6. The prosthetic socket according to one of the preceding claims, characterized in that the side wall (20) is interlockingly fastened to the base (10).

7. The prosthetic socket according to one of the preceding claims, characterized in that the side wall (20) is formed from a plurality of components (21, 22), which can be aligned with each other or loaded toward each other by means of at least one tightening device (50).

8. The prosthetic socket according to one of the preceding claims, characterized in that the supports (40) are designed as a rail extending in the proximal direction.

9. The prosthetic socket according to one of the preceding claims, characterized in that interlocking elements (45) for fastening the side wall (20) are arranged on the supports (40).

10. The prosthetic socket according to one of the preceding claims, characterized in that at least one guide (23, 24) for receiving the supports (40) is arranged on the side wall (20).

11. The prosthetic socket according to one of the preceding claims, characterized in that the side wall (20) is fastened to the supports (40) by means of interlocking elements (42).

12. The prosthetic socket according to one of the preceding claims, characterized in that markings (26, 46) and / or material weakening points (27, 47) are arranged or formed on the side wall (20) and / or the supports (40) as predetermined breaking lines or predetermined cutting lines.

13. The prosthetic socket according to one of the preceding claims, characterized in that at least one support (40) is arranged medially or one support (40) is arranged medially and one support (40) is arranged laterally on the base (10).

14. The prosthetic socket according to one of the preceding claims, characterized in that the at least one side wall (20) has different material stiffnesses and / or different material thicknesses.