PROSTHETIC SHAPE SYSTEM AS WELL AS PROSTHETIC SHAPE AND LINER

Description

[0001] The invention relates to a prosthetic socket system comprising a prosthetic socket and a liner, wherein the prosthetic socket has a distal termination region, at least one socket wall extending proximally thereto, and connecting means for attaching a prosthetic component, wherein the socket wall at least partially encloses a residual limb received in the prosthetic socket in the applied state, and the liner has a proximal entry opening and a distally extending side wall which at least partially surrounds a residual limb in the applied state and is arranged between the residual limb and the prosthetic socket in the applied state, and a coupling device is arranged between the liner and the prosthetic socket in the distal termination region, wherein mutually interacting resistance areas are arranged or formed on the outside of the side wall of the liner and on the inside of the socket wall.which counteract a withdrawal movement of the liner in a proximal direction from the prosthetic socket.

[0002] Prosthetic sockets are used to secure a prosthetic component, such as a joint, prosthetic foot, or prosthetic hand, to a residual limb. The socket provides a sufficiently rigid shell wall that completely or partially encloses the residual limb. Forces from the prosthetic component are transmitted to the residual limb via the shell wall and a distal end. To improve comfort and secure the socket to the residual limb, a liner or prosthetic liner is used. This liner typically rests against the residual limb. The liner is usually made of an elastic material and has a proximal opening. Silicone or another polymer that adheres to the skin surface is commonly used as the liner material.The coupling between the prosthetic socket and the liner can be achieved via a distally arranged locking system, a so-called pin-lock, or via a vacuum system.

[0003] US Patent 8,999,004 B2 discloses a magnetic coupling device for a prosthesis, comprising a stem and a liner. A permanent magnet is arranged inside the stem. A mounting plate is attached to the liner, which is drawn into or pushed out of the prosthesis stem by the permanent magnet, depending on its orientation.

[0004] DE 10 2011 116 280 A1 relates to a connection system for detachably connecting a prosthetic socket to a liner pulled over an amputation stump, comprising a connecting pin and a receiving device into which the connecting pin can be inserted. The connecting pin includes at least two rigid pin segments arranged one behind the other along a longitudinal direction of the connecting pin so as to be displaceable relative to each other.

[0005] US 2015 / 0105867 A1 relates to a prosthetic system comprising a prosthetic socket and a prosthetic liner, wherein complementary form-fitting elements are arranged or formed on the outside of the prosthetic liner and on the inside of the prosthetic socket.

[0006] DE 10 2014 001 000 A1 relates to a connecting device for attaching at least one prosthetic device to a person's residual limb. The connecting device is designed to restrict movement in at least one direction with respect to relative movement between the prosthetic device and the residual limb. It enables a secure connection between the prosthetic device and the residual limb and prevents separation. The connecting device may have a scale-like design.

[0007] US 2010 / 0004756 A 1 relates to a liner with an inner and an outer surface on which fibers are arranged to secure the liner to a residual limb and / or the inner surface of a prosthetic socket, which also has fibers arranged on it. The fibers allow insertion into the prosthetic socket and provide increased resistance to withdrawal.

[0008] The object of the present invention is to provide a prosthetic socket system, a prosthetic socket and a liner, with which improved wearing comfort and easier entry into the prosthetic socket are possible.

[0009] According to the invention, this problem is solved by a prosthetic socket system with the features of the main claim, as well as a prosthetic socket and a liner with the features of the dependent claims. Advantageous embodiments and further developments of the invention are disclosed in the dependent claims, the description, and the figures.

[0010] The prosthetic socket system according to the invention comprises a prosthetic socket and a liner, wherein the prosthetic socket has a distal termination region, at least one socket wall extending proximally thereto, and connecting means for attaching a prosthetic component, wherein the socket wall at least partially encloses a residual limb received in the prosthetic socket in the applied state, and the liner has a proximal entry opening and a distally extending side wall that at least partially surrounds a residual limb in the applied state and is arranged between the residual limb and the prosthetic socket in the applied state, wherein a coupling device is arranged between the liner and the prosthetic socket in the distal termination region, provides that mutually interacting resistance areas are arranged or formed on the outside of the side wall of the liner and on the inside of the socket wall.which counteract a proximal pull-out movement of the liner from the prosthetic socket. The resistance areas are equipped with unidirectional, kink-resistant nubs, ridges, or fibers. The coupling device in the distal end region of the prosthetic socket provides a positive or force-fit connection between the distal end region of the prosthetic socket and the liner, preferably with a distal end cap of the liner. This prevents the liner from detaching from the prosthetic socket during the swing phase or during tensile loading away from the stump. The coupling device prevents loss of contact in the distal region. Such a coupling between the liner and the prosthetic socket is particularly advantageous for lower extremity prostheses, as comparatively large masses and high accelerations occur there.This means that, for example, large tensile forces are exerted on the prosthetic socket system during the swing phase. In addition to a distal coupling device, at least one resistance zone is arranged or formed on the outer circumference of the liner and, correspondingly, on the inner circumference of the socket wall. This resistance zone interacts with the corresponding resistance zone to counteract any withdrawal movement of the liner from the prosthetic socket. In addition to the retention force provided by the coupling device, a force transmission from the prosthetic socket via the liner to the residual limb is distributed over a large area across the circumferential surface of the side wall and the socket wall, thus ensuring effective fixation of the prosthetic socket to the limb.

[0011] In order to be able to remove the prosthetic socket after it has been attached to the stump, the prosthetic socket is preferably designed to be expandable, which makes it possible to increase the socket circumference, eliminate the interaction of the resistance areas and thus facilitate getting out of the prosthetic socket.

[0012] A further development of the invention provides that the prosthetic socket has several socket wall components that can be pivoted or folded relative to one another and are arranged, for example, on a support or a dimensionally stable end structure. The end structure can be bowl-shaped or cap-shaped and have foldable fastening elements for the socket wall components. At least one socket wall component can be folded onto the support or end structure, for example, via a hinge joint, to allow for an increase in circumference. This disengages the resistance zones from one another or eliminates the interaction of the resistance zones, so that after opening the prosthetic socket, only the magnetic coupling needs to be released to remove the liner from the prosthetic socket.

[0013] A further development of the invention provides that the coupling device at the distal end region is designed as a magnetic coupling. The magnetic coupling in the distal end region of the prosthetic socket provides a purely force-fit connection between the distal end region of the prosthetic socket and the liner, preferably with a distal end cap of the liner. The magnetic coupling prevents a loss of contact in the distal region, which is often perceived as unpleasant. The magnet(s) enable simple, force-fit, and large-area fixation of the liner to the prosthetic socket. No mechanical locking devices need to be activated or deactivated. The alignment of the liner relative to the prosthetic socket is forgiving of errors, and the insertion or retraction movement into the prosthetic socket is also supported.The coupling device can also be designed as a mechanical lock, for example as a Pinlock or hook-and-loop fastener, or another form-fitting lock where interlocking elements secure themselves against each other. Locking via hook-and-loop fasteners or similar systems has the advantage over a single locking element that the alignment during insertion does not need to be as precise, and furthermore, rotation is prevented.

[0014] The prosthetic socket can be equipped with at least one tensioning device that reduces the circumference of the socket wall. This tensioning device allows, for example, socket wall components to be moved towards each other, thus enabling adaptation to different residual limb volumes and allowing the resistance zones to interact or engage with one another. The tensioning device can be designed as a belt system or a cable system with a winding or unwinding mechanism, allowing, for example, the effective length of the belt or cable to be increased or extended by rotating the tensioning device. This, in turn, moves socket wall components towards or away from each other.In addition to the embodiment with multiple shaft wall components, one embodiment of the invention provides that the shaft wall has an open cross-section at one point and that the opposing edges of the shaft wall overlap, so that by activating the clamping device the circumference of the prosthetic shaft is reduced or increased.

[0015] The prosthetic socket can be elastically pre-tensioned in or against a radial expansion movement, so that the socket must be reduced in circumference against a pre-tensioning force via the clamping device. This facilitates opening the prosthetic socket. Alternatively, a pre-tensioning force can be applied in the direction of a reduction in circumference, so that to insert the prosthetic socket, it must be opened against a pre-tensioning force, allowing the prosthetic socket to automatically conform to the liner after release.

[0016] The prosthetic socket can be designed to be self-closing, for example, by means of a strap system attached to a hinged socket wall component. When the liner is inserted into the socket, this system causes the components to pivot towards each other. A suitable strap guide can also apply a circumferential clamping or closing force to the socket wall when the prosthetic socket is inserted.

[0017] The prosthetic socket can be modular, consisting of a carrier and separately manufactured socket wall components attached to it. The socket wall components can be fixed to the carrier reversibly or irreversibly. This modular design allows for the use of industrially prefabricated parts, which can be made adjustable, particularly with regard to the prosthetic socket length. The overall socket length can be easily adjusted by shortening the individual components.

[0018] In Magnets with alternating polarity can be arranged in the distal end region and / or in a distal liner end region to ensure alignment and orientation of the prosthetic stem relative to the liner, even circumferentially. The corresponding polarity of the magnets results in a fixed relationship between the prosthetic stem and the liner, thus eliminating the need for additional anti-rotation devices.

[0019] The resistance zones can be designed or equipped with interlocking elements and / or adhesive zones. The interlocking elements can be designed as a climbing skin, velour, or hook-and-loop fasteners. The resistance zones can be designed as or with nubs, grooves, protrusions, undercuts, interlocking areas, roughening, or other shapes. Additionally or alternatively, resistance zones can be designed as adhesive zones that cause the liner to adhere to the prosthetic socket. By opening the liner and / or expanding its circumference, it is possible to disengage the respective resistance zones from each other, thus also allowing the user to remove the prosthetic socket.

[0020] Permanent magnets or at least a ferromagnetic element can be arranged in the distal end region. The corresponding component for forming a magnetic coupling with the prosthetic stem is then located in the liner end region; that is, at least a ferromagnetic element if a permanent magnet is used, or a permanent magnet if a ferromagnetic element is located in the distal end region. When arranging permanent magnets in both the distal end region and the liner end region, appropriate pole orientation must be ensured to provide a reliable magnetic coupling.

[0021] In the distal end region of the prosthesis stem, a metal plate with a fastening device, such as a thread, can be arranged for securing the distal connection elements. These connection elements are, in particular, a pyramid adapter or a receptacle for the pyramid adapter.

[0022] A further development of the invention provides that the resistance zones are switchable and / or that a separating device can be positioned, in particular inserted, between the prosthetic socket and the prosthetic liner, so that a separating layer or a separating element can be placed, at least partially, between the resistance zones. The resistance zones, or at least one resistance zone, can have elements that are inclined in the insertion direction into the prosthetic socket or that can be moved from a locking position to a release position or vice versa. For this purpose, the elements can be shifted to a different orientation or to an exposed and retracted position. This reduces the resistance to the withdrawal movement and facilitates removal of the prosthetic socket.The displacement or reorientation of the elements within the resistance zones can be achieved mechanically or by other means, such as switchable magnets. The separation device is designed, for example, as a slider that is fixed to the prosthetic socket in a way that allows for movement, or it can be designed as a separate component. The separation device can be mounted on the prosthetic socket so that it can be slidably or rotatably positioned, for example, in a pocket or recess located next to the resistance zone. To separate the resistance zones, the separation device is inserted between them, so that only the magnetic forces need to be overcome to allow the elements to exit the prosthetic socket.The design of the prosthetic socket system with prosthetic socket and prosthetic liner with interacting resistance areas and a separating device can also be used independently of an additional magnetic coupling and is designed as a stand-alone solution.

[0023] The resistance zones can include articulated or flexible locking bodies or resistance elements that, due to their orientation or position, form a progressive friction system with the outer surface of the prosthetic liner. To remove the prosthetic from the socket, these locking bodies or resistance elements, which may be designed, for example, as ridges, bristles, scales, pins, or projections, can be unlocked and removed from engagement, contact, or interaction with the liner.

[0024] The locking elements or resistance components can protrude through the release mechanism or, in the resistance position, extend beyond it. For this purpose, the release mechanism may, for example, have recesses through which the locking elements or resistance components protrude. To reduce or eliminate the resistance, or to separate the resistance zones from one another, the release mechanism is moved into an unlocking position, for example, by twisting or sliding. This bends the locking elements or resistance components away from the surface of the liner, creates a barrier between the liner and the prosthetic socket, or achieves some other form of decoupling, allowing the liner to be pulled out of the prosthetic socket. The release mechanism can also be designed as a film. With a suitable release mechanism, it is possible to easily withdraw from a closed-walled socket without exerting significant force.

[0025] The statements regarding the claimed prosthetic socket system also apply accordingly to prosthetic socket systems without an additional coupling device in the distal end area.

[0026] The prosthetic socket for use in a prosthetic socket system described above has a distal termination area, at least one socket wall extending proximal to it, and connecting means for attaching a prosthetic component, wherein the socket wall at least partially encloses a residual limb received in the prosthetic socket in the applied state, and a magnetic coupling is arranged in the distal termination area, and provides that at least one resistance area is arranged or formed on the inside of the socket wall, which acts against a withdrawal movement of a liner in the proximal direction from the prosthetic socket, and that the at least one resistance area is equipped with unidirectional, kink-resistant studs, ridges, or fibers.

[0027] In a further development of the invention, the prosthesis stem is radially expandable, thus facilitating its removal. The coupling between the resistance zones is eliminated or at least significantly reduced, so that moving the prosthesis stem away from the liner facilitates a withdrawal movement.

[0028] The prosthetic socket can have several socket wall components that are pivotable or foldable relative to each other, and at least one clamping device can be arranged on the prosthetic socket that causes a reduction in the circumference of the socket wall. The prosthetic socket can be elastically prestressed in or against a radial expansion movement and may optionally be designed with a strap system, thereby making the prosthetic socket self-closing. With prestressing against an expansion movement, the prosthetic socket is self-closing due to the elastic prestress.

[0029] The prosthetic socket is preferably modular in design and comprises a carrier and separately manufactured socket wall components attached to it, in order to easily customize industrially prefabricated components. The socket wall components can be reversibly arranged on the carrier or on attachments mounted or affixed to it, to allow for adaptation to changing patient conditions.

[0030] Magnets, particularly permanent magnets with alternating polarity or a ferromagnetic element, may be arranged in the distal end region of the prosthetic stem and / or in the liner end region. The ferromagnetic element may simultaneously serve as a receptacle for securing the distal connecting elements and may include a fastening device, e.g., a thread, for their fixation.

[0031] The resistance area on the inside of the side wall can be designed with positive locking elements and / or adhesive areas and / or suction cups or a suction cup area to enable a positive or non-positive coupling with the outside of a liner. The resistance areas can include magnets or hook-and-loop fasteners. The resistance area is preferably switchable or has switchable resistance elements, so that it can be set when and to what extent resistance to an extension movement is provided, or an extension movement is blocked or released.

[0032] A liner for use in a prosthetic socket system, as described above, provides a proximal entry opening and a distally extending side wall that at least partially surrounds a residual limb in the applied state and is positioned between the residual limb and a prosthetic socket in the applied state, wherein a magnetic coupling is arranged in a distal end region of the liner, wherein at least one resistance area is arranged and formed on the outside of the side wall of the liner, which counteracts a withdrawal movement of the liner in a proximal direction from the prosthetic socket, and which at least one resistance area is equipped with studs, ridges or directed fibers.

[0033] The resistance zone(s) can be designed or equipped with positive locking elements and / or adhesive zones. Magnets, particularly with alternating polarity, or at least a ferromagnetic element, can be arranged in the distal liner end region to create magnetic coupling with a prosthetic stem. The magnets are preferably permanent magnets.

[0034] Exemplary embodiments of the invention are explained in more detail below with reference to the accompanying figures. These show: Figure 1 – exploded view of a prosthetic socket; Figure 2 – a prosthetic socket in its fully assembled state; Figure 3 – a side view of a fully assembled prosthetic socket; Figure 4 – an oblique top view according to Figure 3 Figure 5 - a variant of the Figure 1Figure 6 - a detailed view of a resistance area; Figure 7 - a sectional view through a resistance area; Figures 8 and 9 - views of prosthetic liners; Figure 10 - a detailed view of a resistance area with a separating device; and Figure 11 - a schematic sectional view through an applied prosthetic socket system.

[0035] Figure 1 Figure 1 shows an exploded view of a prosthetic socket 1 with a carrier 10 to which two socket wall components 21, 22 are detachably attached. In the assembled and applied state, the two socket wall components 21, 22 completely surround the residual limb (not shown) and form a socket wall 20 enclosing the residual limb. In an alternative embodiment, the socket wall 20 can also be formed in one piece and have either a closed or an open cross-section.

[0036] In the illustrated embodiment, the carrier 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 carrier 10 and thus to the prosthetic socket via corresponding positive locking elements or ferromagnetic components.

[0037] Extending proximally from the dimensionally stable cap 10 are two fastening elements 40, designed as rails. When the prosthetic socket 1 is in place, the fastening elements 40 are positioned on the medial and lateral sides of the residual limb and can be of equal or different lengths, with a greater length preferably provided on the lateral side. Through-holes 45 are arranged within the rail-shaped fastening elements 40 as positive-locking elements for securing the socket wall 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 fastening elements 40.The laterally arranged fastening element 40 is hinged to the carrier 10 via a hinge 13. The medial fastening element 40 is integrally formed with the distal cap 11, creating an L-shaped, rigid base. In addition to a pivotable mounting of the medial fastening element 40, it can also be slidably mounted on the carrier 10 to allow adjustment of the stump width in the distal region. It is also possible to design both fastening elements 40 to be hinged, or to rigidly mount the medial fastening element 40 to the rigid cap 11. Furthermore, more than two fastening elements 40 can be formed on or arranged on the carrier.

[0038] The shaft wall components 21, 22, and thus the entire shaft wall 20, are detachably attached to the support 10. For this purpose, guides 23, 24 for the fastening elements 40 are attached to the outer surfaces of the shaft wall components 21, 22. The guides 23, 24 are designed as rail receptacles that correspond to the rail-like configurations of the fastening elements 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 fastening elements 40 or having opposing flanges, so that the respective fastening elements 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 fastening elements 40 are fixed in both the medial and lateral directions, but are still guided in the longitudinal extension of the fastening elements 40 in the guides 23, 24 in a slidable manner.

[0039] Corresponding to the through holes 45 in the fasteners 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 shaft wall components 21, 22 are connected to the respective fasteners 40 by means of positive locking elements 42 in the form of screws. For this purpose, the fasteners 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 shaft wall 20 to the support 10.The through holes 45 can also be designed as elongated holes to allow virtually stepless adjustment of the position of the shaft wall components 21, 22 relative to the support 10. An elongated hole extending over the entire length can also be formed, so that, in addition to a positive locking fixation of the shaft wall 20 to the fastening elements 40, longitudinal displacement along the guides 23, 24 is blocked by clamping via the screws 42 and a washer 43.

[0040] In the distal region of the socket wall 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 socket wall components 21, 22, or completely around the entire socket wall 20 if it is a one-piece design. 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 fastening elements 40, preferably at their proximal ends, and allow for individual adjustment of the length of the entire prosthetic socket 1.

[0041] The shaft wall components 20 and 21 form a proximal shaft portion as the shaft wall 20, while the support 10 with the fastening elements 40 forms a distal shaft portion. These components are designed and arranged to be longitudinally displaceable relative to each other and lockable in place, allowing for either stepless or stepless adjustment and fixability. By shortening the distal shaft portion in the form of the support 10 and / or the proximal shaft portion in the form of the shaft wall 20, the shaft length can be reduced. This makes it possible to use industrially prefabricated shaft components to adapt a prefabricated shaft to individual stump lengths. The desired load on the stump end can also be adjusted and set.

[0042] A clamping device 50 is arranged on the lateral socket wall component 21, allowing the socket width to be varied, for example, via a cord-cable strap system. Due to the two-part design of the socket wall 20 in the illustrated embodiment, as well as the hinged mounting of the lateral socket wall component 21 on the support 10, it is possible and necessary to fix the relative positions of the socket wall components 21 and 22 in the circumferential direction. The hinged design of the support 10 and the resulting expansion of the prosthetic socket 1 facilitates entry into the prosthetic socket. This also makes it possible to arrange or form positive locking elements 28 on the inside of the socket 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 socket 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.

[0043] In the illustrated embodiment of the Figure 1The socket wall components 21 and 22 are designed differently. The medial socket wall component 22 extends over more than half of the total circumference, in this case 3 / 4 of the total circumference, while the lateral socket wall component 21 is dimensioned to provide additional circumference, allowing the prosthetic stump to be fully enclosed. The lateral edges of the socket wall 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.

[0044] A fully assembled prosthetic socket 1 is in the Figure 2The distal, dimensionally stable cap 11, the hinge assembly 13 for the lateral attachment element 40, and the socket wall 20, consisting of a lateral socket wall component 21 and a medial socket 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 socket wall component 22 and, by shortening them, reduce the circumference. By rotating the clamping devices 50 in the opposite direction, the circumference of the prosthetic socket can be increased. The lateral socket wall component 21 is detachably fixed to the carrier 10 by a total of four screws 42. The screws 42 are guided through the through holes 45 in the attachment element 40 and screwed into the internal threads 25 within the guide 23.The washer 43 provides an additional clamping effect.

[0045] Figure 3 Figure 1 shows a side view of the prosthetic socket 1 in an open position, with the two socket wall components 21, 22 already attached to the carrier 10. The two socket wall components 21, 22 extend to the dimensionally stable cap 11 in the assembled state, so that the prosthetic socket 1 almost completely encloses the residual limb (not shown) with the liner. Figure 3 It can also be seen that the left shaft wall component 21 partially covers the right shaft wall component 22 at the edges, so that the prosthetic shaft 1 completely surrounds the stump over almost its entire length.

[0046] In the Figure 4 is the prosthetic socket 1 in the design according to Figure 3The diagram shows an oblique top view. The clamping devices 50 are visible on the frontal socket wall component 21, as are the resistance areas 28 on the inside of the frontal socket wall component 22. The second socket wall component 22 surrounds the residual limb (not shown) by more than three-quarters of its circumference. Due to the open cross-section of the socket wall component 22, the prosthetic socket 2 can be expanded circumferentially. Padding 220, made of a softer material than the rest of the socket wall component 22, is arranged at the proximal posterior edge of the posterior socket wall component 22 to provide cushioning and increase wearing comfort.Resistance areas 28 are also formed on the inside of the second shaft wall component 22, which interact with the prosthetic liner (not shown) and provide resistance against a withdrawal movement from the prosthetic shaft 2 or form a positive locking mechanism between the liner and the prosthetic shaft 1.

[0047] Figure 5 shows a variant of the Figure 1with the prosthetic socket 1 in an unassembled state. Instead of the resistance areas 28 formed in the frontal socket wall component 22, which are provided, for example, by corresponding ribbing, a sawtooth-like surface design, knobs, grooves, or other profiling, a mounting area 28' for a separately manufactured resistance area 28 is arranged on the frontal socket wall component 21. The resistance area 28 or resistance areas 28 are detachably attached to the respective socket wall component 21, 22, thus allowing replacement in case of wear or adaptation to the individual user, for example, to enable increased adhesion of the liner to the prosthetic socket 1.

[0048] The surface area of ​​the resistor region 28 is enlarged in the Figure 6The diagram shows oriented ridges, studs, or fibers inclined towards the distal end or the rigid cap 11, so that when the prosthesis liner is inserted into the prosthesis stem 1, it encounters little or no resistance. As it slides in, the studs, ridges, or fibers conform to the inner wall of the stem, allowing the prosthesis liner to glide along it during insertion. During an opposing movement, the tips of the ridges, studs, or fibers interlock and straighten, exerting radial pressure on the prosthesis liner and simultaneously blocking withdrawal due to the resistance provided by the ridges, studs, or fibers. The ridges, studs, or fibers can be designed to be relatively resistant to bending, making it difficult or impossible to bend them during withdrawal or movement against the insertion direction.

[0049] To remove the prosthetic socket 1, the clamping device 50 can be opened and one socket wall component 21 can be folded away from the prosthetic liner and / or the open cross-section of the other socket wall component 22 can be bent open, so that the liner with the residual limb can be easily removed from the prosthetic socket 1. Only the magnetic forces through the magnetic coupling at the distal end need to be overcome. The magnets arranged for this purpose on the prosthetic liner 2 can adhere to the metal plate 16, which is located on the inside of the rigid cap 11.

[0050] One option for releasing the prosthesis or providing an exit option from the prosthesis socket 1 is to insert a separating shield between the outer surface of the prosthesis liner and the inner surface of the prosthesis socket 1, for example, a flat plastic slider that conforms to the contour of the residual limb. Once the interlocking resistance elements, such as ridges, studs, structural elements, or oriented fibers of the resistance areas 28, are covered by the slider or separating device, there is no longer any interaction between the resistance areas, and the prosthesis liner, together with the residual limb, can simply be pulled out of the prosthesis socket 1.

[0051] In the Figure 7The orientation of the webs of the resistance areas 28 is shown in a cross-sectional view. It can be seen that there is a smooth outer wall, on the opposite side of which the structural elements, such as webs, ribs, studs or the like, are arranged inclined in the insertion direction indicated by the arrow.

[0052] Figure 8Figure 1 shows a prosthetic liner 2 with a proximal entry opening 3 and a distal end cap in a distal liner end region 5. The distal end cap can, for example, be designed as a ferromagnetic plate 62, which has a thread for receiving a locking element, such as a pin, or for a connection for a suction device. A closed side wall 4 extends proximally from the distal liner end region 5, on the outer side of which a resistance area 8 is arranged, extending in the illustrated embodiment to just below the proximal entry opening 3. The resistance area 8 can, by means of a specific shape, form a positive-locking engagement with the components of the correspondingly shaped resistance areas 28 on the inner side of the socket.Additionally or alternatively, adhesion areas can be arranged or formed on the outer surface of the side wall 4 of the prosthetic liner 2 to provide increased resistance to the liner 2 being pulled out of the prosthetic socket 1 in a proximal direction. The resistance area 8 can also be designed as a fabric, loop, velour, directional fibers, studs, ridges, ribs, a magnetic area, a hook-and-loop fastener, or a suction cup area, or with suction cups or the like. The material of the liner 2 in the area of ​​the side wall 4 is preferably elastic. Advantageously, the liner consists of an elastomer such as silicone, polyurethane, or TPE. Alternatively, the liner can also consist of a spacer fabric. Advantageously, in this case, the spacer fabric is at least partially coated on the body-facing side with an adhesive elastomer to prevent pull-out. A spacer fabric has the advantage of being breathable.The liner itself can be covered with a textile or a friction-reducing surface coating to facilitate entry. The textile can serve as a friction zone, eliminating the need for an additional friction zone. A matrix can also be incorporated into or attached to the liner to prevent the so-called milking effect by reducing longitudinal elasticity.

[0053] One variant of the prosthetic liner 2 is in the Figure 9Figure 5 shows a system in which magnets 61 are arranged below a distal end cap 63 and are positioned in recesses within the distal liner end region 5. Receptacles or holders for the magnets 61 are provided in a liner end cap 51. The magnets 61 can have alternating polarity, allowing for angular orientation and alignment of the liner 2 relative to, for example, correspondingly arranged magnets in the rigid cap 11. In addition to adhesion via the magnetic closure in the liner end region 5 and the adhesion, locking, or resistance provided by the resistance areas 8, 28, this arrangement prevents the prosthetic socket 1 from rotating relative to the liner 2. This results in increased safety for the user of the prosthetic socket system consisting of the prosthetic socket 1 in conjunction with the illustrated prosthetic liner 2.

[0054] By means of a ferromagnetic element 16, 62 in conjunction with permanent magnets 14, 61 or by direct magnetic coupling of several permanent magnets to each other, it is possible to provide a locking mechanism in the distal end area in addition to an adhesive or form-fitting connection in the side wall area and the prosthesis shaft area, which enables precise alignment of the liner 2 with the stump within the prosthesis shaft 1, without requiring a highly precise insertion of a form-fitting locking mechanism, for example in the form of a pinlock.

[0055] Figure 10Figure 1 shows a schematic sectional view of a prosthetic socket 1 with locking elements or resistance elements arranged on its inner surface within a resistance area 28. The arrows in the resistance area 28 indicate the different resistance directions in which maximum resistance to movement along the surface is provided. In addition to different resistance directions, it is also possible for resistance to be provided only in one direction, for example, the insertion direction of the prosthetic socket.

[0056] Within the prosthetic socket 1, a longitudinal slot 29 is formed in the socket wall 22, in which a pin 71 is slidably mounted. The pin 71 has an actuating element 72 or a handle on its outer surface, by means of which the pin 71 can be moved along the recess 29. The actuating element 72 is accessible from the outside of the prosthetic socket 1, in particular it is arranged on the outside of the socket wall 20. On the side opposite the actuating element 72, which abuts the socket wall 22 inside the prosthetic socket 1, a separating device 70 is arranged, which is designed as a slider, separating plate, or foil. In the illustrated embodiment, the separating device 70 is essentially triangular and has one point facing the distal end of the prosthetic socket 1, which is only indicated.

[0057] In the depicted state, the separating device 70 is essentially disengaged from the resistance area 28 and the locking elements, resistance components, or the like arranged therein or on it. To disengage a positive-locking engagement between the resistance areas 8 and 28, or to release a frictional connection, or to switch the resistance components or locking elements from an engagement position to a release position in which the prosthetic liner (not shown) can be moved out of the prosthetic socket 1, the separating device 70 is shifted to the right and moved across the resistance area 28. This disengages, decouples, or reduces the adhesive or resistance forces of the resistance areas 8 and 28 of the liner and the prosthetic socket, thus eliminating their interaction, allowing the patient to step out of the prosthetic socket 1.The inner surface of the separating device 70 is preferably smooth. The separating device 70 can be flexible to adapt to the contour of the shaft and the stump.

[0058] The different orientations of the resistance elements, locking bodies, or resistance sections within the resistance area 28 not only reduce the tendency for withdrawal but also fix the prosthetic liner (not shown) within the prosthetic socket 1 with respect to rotation about a longitudinal axis. The rotational stability of a prosthetic socket relative to a prosthetic liner is a crucial factor for a user's perception of stability and can be achieved through differently oriented elements, such as differently oriented bristles, fibers, ridges, scales, grooves, surface textures, or the like. The resistance elements can be elastically mounted or flexible.

[0059] Another variant of the separating device is in the Figure 11Figure 1 shows a schematic partial view of a prosthetic socket system with a prosthetic socket 1 and a liner 2 arranged therein. A resistance area 28 is applied to the inside of the socket wall, which has inwardly projecting resistance elements 280 or locking bodies inclined in the direction of insertion, indicated by the downward arrow. A separating device 70 is provided with recesses 75 through which the resistance elements 280, which in the illustrated embodiment are designed as a plurality of ridges, bristles, or ribs, project. InIn the position shown, the resistance elements 280 interact with the outer surface of the prosthetic liner 2 and, due to their inclination, allow the prosthetic liner 2 to be inserted into the prosthetic socket 1. The resistance elements 280 prevent or at least inhibit any opposing movement, as they would press against the outer wall of the prosthetic liner 2, bend upwards, and thus provide resistance to an extraction movement by wedging themselves in place. This effect can be intensified by pulling out or upwards the separating device 70, which is designed as a slider. When the separating device 70 is pulled upwards, the resistance elements 280 are straightened and pressed against the outer wall of the prosthetic liner 2.

[0060] To enable or facilitate the withdrawal movement, the separating device 70 is moved in the insertion direction of the prosthesis liner 2. This increases the inclination of the resistance elements 280, which pass through the recesses 75, and presses them against the socket wall 20 or against the surface of the resistance area 28, thus disengaging them from the prosthesis liner 2. The tips or ends of the resistance elements 280 are then located within the recesses 75 and are protruded by the inner surface of the separating device 70, so that there is no or only minimal interaction between the resistance elements 280 and the prosthesis liner 2. The prosthesis liner 2 can then be withdrawn from the prosthesis socket 1. To provide increased resistance, the separating device 70 is moved upwards, and the resistance elements 280 are erected and their inclination changed.

Claims

1. A prosthetic socket for use in a prosthetic socket system with a liner, with a distal end region (11), at least one socket wall (20) extending therefrom in proximal direction and connection means (15) for securing a prosthetic component, wherein the socket wall (20), when in the applied state, at least partially encloses a stump that is received in the prosthetic socket (1), and a coupling device (14) arranged in the distal end region (11), wherein on the inner side of the socket wall (20), at least one resistance region (28) is arranged or formed which counteracts a movement extracting a liner (2) out of the prosthetic socket (1), in proximal direction , whereas the at least on resistance region (28) is provided with stays, naps or directed fibers, characterized in that the stays, naps or directed fibers are kink resistant, with the result that, when extracting or moving opposite the direction of introduction, bending is not possible, or possible only with difficulty.

2. The prosthetic socket according to claim 1, characterized in that the prosthetic socket (1) can be extended radially.

3. The prosthetic socket according to claim 1 or 2, characterized in that the prosthetic socket (1) has several socket wall components (21, 22) arranged swivelable or foldable to one another.

4. The prosthetic socket according to one of the preceding claims, characterized in that, at the prosthetic socket (1), at least one clamping device (50) is arranged which causes a reduction in circumference of the socket wall (20).

5. The prosthetic socket according to one of the preceding claims, characterized in that the prosthetic socket (1) is pretensioned elastically in or counter to a radial extension movement.

6. The prosthetic socket according to one of the preceding claims, characterized in that the prosthetic socket (1) is formed to be self-closing.

7. The prosthetic socket according to one of the preceding claims, characterized in that the prosthetic socket (1) is formed modularly with a support (10) and socket wall components (21, 22) secured thereto and produced separately.

8. The prosthetic socket according to one of the preceding claims, characterized in that, in the distal end region (11), magnets, in particular with alternating polarity, or a ferromagnetic element (16), are arranged as coupling device (14).

9. The prosthetic socket according to one of the preceding claims, characterized in that the resistance region (28) is additionally formed with form-locking elements and / or adhesion regions.

10. The prosthetic socket according to one of the preceding claims, characterized in that the resistance region (28) is formed switchable or has switchable resistance elements.

11. The prosthetic socket according to one of the preceding claims, characterized in that a separating device (70) is arranged at the prosthetic socket.

12. A liner for use in a prosthetic socket system according to one of the preceding claims, with a proximal entry opening (3) and a lateral wall (4) extending in distal direction, which, when in the applied state, at least partially surrounds a stump and, when in the applied state, is arranged between the stump and a prosthetic socket (1), wherein a coupling device (6) is arranged in a distal liner end region (5), wherein on the outer side (5) of the lateral wall (4) of the liner (2), at least one resistance region (8) is arranged or formed, which counteracts a movement extracting the liner (2) out of the prosthetic socket (1) in proximal direction, wherein the at least on resistance region (8) is provided with stays, naps or directed fibers, characterized in that in the distal liner end region (5) magnets (61) or at least one ferromagnetic element (62), are / is arranged as coupling device (6).

13. The liner according to claim 12, characterized in that the resistance region (8) is additionally formed with form-locking elements and / or adhesion regions.

14. The liner according to claim 12 or 13, characterized in that magnets (61) are arranged with alternating polarity.

15. Prosthetic socket system with a prosthetic socket (1) according to one of the claims 1 to 11 and a liner (2) according to one of the claims 12 to 14, wherein the coupling devices (6, 14) in the distal end region (11) and the distal liner end region (5) are acting between the liner (2) and the prosthetic socket (1) and that the resistance regions (8,28) interact with one another.