ORTHOPEDIC SOCIAL SECTOR AND PROCEDURES FOR ITS INSTITUTION

Description

[0001] The invention relates to an orthopedic socket, in particular a prosthetic socket, for contact with and for receiving a limb stump or a limb, having at least one socket wall, a proximal entry opening, and a distal end, and at least one fastening device arranged on the socket for securing at least one distal orthopedic component. The invention also relates to a method for adjusting such an orthopedic socket.

[0002] Orthopedic sockets, particularly prosthetic sockets, are used to accommodate limb stumps or limbs and can have a variety of designs. One design of a socket provides for the limb or limb stump to which the socket is to be attached to be molded. The socket is then modeled onto this shape, possibly with additional material, for example, from a thermoplastic or a fiber composite material. The socket wall is generally closed-walled and dimensionally stable and has a proximal entry opening. Devices for attaching additional components, such as joints or the like, are arranged, particularly incorporated, at the distal end or distal end region.

[0003] Alternatively, the shafts can be manufactured using an additive manufacturing process.

[0004] To achieve a better fit and adapt to different contours or volumes, prosthetic sockets are manufactured with an open cross-section or from multiple, relatively movable components. Motors or traction mechanisms position the components relative to each other, tighten them, and secure them in their respective positions. By loosening the traction mechanism or a lock, the socket volume, which accommodates the limb or stump, can be increased. This occurs, for example, when donning and doffing the socket or to relieve pressure on the limb or stump, such as when sitting.

[0005] The sockets, especially prosthetic sockets, hold the other orthopedic components securely to the limb or limb stump and also ensure that the other orthopedic components are correctly aligned with the limb or limb stump. To achieve this, the orthotic socket or prosthetic socket must have sufficient rigidity and stability to ensure secure guidance of the attached orthopedic component.

[0006] Fixed, rigid contact surfaces, such as the ramus contact, are necessary for adequate positioning of the socket on the limb or limb stump. However, such rigid contact surfaces are disadvantageous in terms of comfort.

[0007] WO 2016 / 091763 A1 relates to a prosthetic socket for the lower extremity, comprising an outer socket for receiving an inner socket, wherein the inner socket is designed to receive a limb stump of the lower extremity. The outer socket has a peripheral portion and at least one adjustment device, which is part of the outer socket or is connected or connectable to the outer socket. When actuated, the adjustment device changes the shape of the outer socket or changes the stiffness of the prosthetic socket or the outer socket, at least in the region of the peripheral portion, while maintaining the same circumference of the peripheral portion.

[0008] The object of the present invention is to provide an orthopaedic shaft and a method for adjusting an orthopaedic shaft, with which an increase in wearing comfort is achieved while at the same time maintaining precise guidance of orthopaedic components.

[0009] According to the invention, this object is achieved by an orthopedic shaft having the features of the main claim and a method having the features of the subordinate claim. Advantageous embodiments and further developments of the invention are disclosed in the subclaims, the description, and the figures.

[0010] The orthopedic socket for attachment to and for receiving a limb stump or a limb, comprising at least one socket wall, a proximal entry opening, a distal end, and at least one fastening device arranged to secure at least one distal orthopedic component to the socket, provides that at least one stiffening element is arranged on or in the socket wall, to which an adjustment device is assigned and via which the stiffness of the socket wall can be changed, in particular reversibly, at least in certain regions. With such a socket, it is possible for certain surfaces or regions of the socket wall to exhibit the required stiffness or rigidity only when necessary.In particular, the stiffness can be adjusted in different areas for different usage situations to ensure either precise guidance and stable support of the limb or limb stump or to provide sufficient flexibility so that the socket is comfortable to wear.

[0011] The stiffening element works in combination with the shaft wall and serves to modify the stiffness in the corresponding areas. The stiffening element is, in particular, an additional component on a shaft that is attached, arranged, formed, or integrated therein.

[0012] One embodiment of the shaft provides for the stiffening element to be displaceably mounted in or on the shaft wall, allowing positioning in the immediate vicinity of the areas whose stiffness is to be changed. Mounting on the shaft wall, particularly on the outer side of the shaft wall, facilitates accessibility, for example, for carrying out repairs or making adjustments. An arrangement within the shaft wall utilizes the shaft wall itself for protection and to form a housing, thus protecting the stiffening element from external influences. Mounting or arranging it within the shaft wall enables a compact design and, in particular, a smooth-surfaced contour of the outer shaft wall.

[0013] One variant provides for a motorized drive to be assigned to the stiffening element, e.g., via an adjustment element arranged between the drive or adjustment device and the stiffening element. The drive or adjustment device makes it possible to twist, shift, bend, or otherwise displace or manipulate the adjustment element and / or the stiffening element in order to achieve the desired change in stiffness in the respective area of ​​the shaft wall. A linear actuator is also considered a motorized drive, as are switchable magnetic devices that effect a displacement.

[0014] In one embodiment, the adjusting element is designed as a gear, roller, crank, lever, traction mechanism, rotary element, piston, thrust mechanism, and / or valve. Traction mechanisms are components or parts that transmit tensile forces. The traction mechanisms can be rigid or flexible; in particular, they can be flexible and inelastic, in particular both compressively flexible and rigidly rigid. In principle, it is also possible for the traction mechanisms to have elasticity, so that they can simultaneously serve as force accumulators and force limiters. Rotary elements that are displaced about a pivot point or axis of rotation can be designed, for example, as wheels, rollers, shafts, spindles, screws, or even rotatable or twistable components such as cords or chains or rods.Pistons are moved linearly and displace a medium; in an alternative design, the pistons are designed as rotary pistons and displace the respective medium not through a linear movement, but through a rotational movement around a rotational axis of the rotary piston. Thrust elements are components that transmit compressive forces, for example rods, connecting rods, rigid chains, or other pressure-rigid components, optionally in combination with elastic components that enable force storage and force limitation. If the stiffness is adjusted via a supply or discharge of fluids, in one design valves are designed as switching valves, adjustment valves or other adjustable flow restrictors with which the flow rate can be adjusted or a flow channel can be blocked. The energy accumulators are designed in particular as springs, compressible fluids, storage devices for electrical energy or storage devices for thermal energy.

[0015] The adjustment device is designed as an electromagnet, pump, electric motor, heater, cooling element, piezo element, electroactive polymer, energy storage device, manually operable device or voltage source. Using the adjustment device, it is possible to adjust or change the corresponding stiffening element or, if applicable, the adjustment element in order to adapt and change the stiffness in the area of ​​the socket wall. Using the electromagnet, either a stiffening element or adjustment element can be displaced or a magnetic field can be generated in order to change the viscosity of a magnetorheological fluid. Using a pump, a fluid or other pumpable medium can be pumped into or out of a volume in order to change the stiffness of the volume and thus of the area of ​​the prosthetic socket in which the volume is located.If, for example, liquid is pumped into a volume, the stiffness in the area containing the volume generally increases due to the increased internal pressure. Stiffness can also be increased if the volume is filled with structural elements and a vacuum is created. The negative pressure presses the side walls against the structural elements, increasing the stiffness of the shaft in this area. Mechanical components can be adjusted using an electric motor. For example, elements with different area moments of inertia can be rotated or reoriented to allow the stiffness to be adjusted. A motor can also drive pumps, relocate or wind up power transmission devices, and adjust valves. Using heating, for example a resistance heater, the viscosity and stiffness can be changed by heating specific areas.Conversely, strength can be increased by cooling certain areas.

[0016] In one embodiment, at least one stiffening element arranged in or on the shaft wall is assigned to the adjustment element and / or the adjustment device. The stiffening element is displaced, activated, its nature changed, oriented differently, and placed in a different relationship to other elements in order to thereby effect a changed stiffness in the respective region in or on which the stiffening element is arranged. The stiffening element can be designed, for example, as a fluid volume, shape memory element, corrugated body, accordion element, toothed body, spring, foam body, phase change material, flap element, slider, insert, damper, or electro-adhesion element.

[0017] In one variant, the adjusting device has an actuator that can be activated and deactivated via a control device assigned to it, wherein the control device is coupled to at least one sensor and activates or deactivates the actuator based on sensor data. Instead of or in addition to a sensor, the control device can also be coupled to a switch or switching device, via which it is possible to activate the actuator manually. The switching device can be designed, for example, in the form of a remote control or a mobile phone or a mobile data processing device that can be coupled to the control device. The coupling can be via a cable connection or wirelessly, for example via a radio interface. For this purpose, corresponding interfaces are assigned to or arranged on the mobile data processing device and the control device.If the adjustment device is automatically controlled based on sensor data, the sensor data is evaluated in the control device or, alternatively, in an external evaluation unit. The control device has the necessary components such as a communication interface, memory, processors, energy storage, and, if necessary, signal amplifiers and integrated circuits. The control device can be coupled to one or more sensors, with the sensor or sensors being selected from a group of sensors comprising a temperature sensor, an acceleration sensor, an inertial measurement unit (IMU), a spatial position sensor, an inclination sensor, a force sensor, an optical sensor, a collector electrode, a pressure sensor, a strain gauge, and a resistance sensor.The optical sensor is used, for example, to detect oxygen saturation or measure blood sugar levels, while the electrodes record myoelectric signals. The resistance sensor measures, for example, the moisture on the inside of the socket wall and can use this to draw conclusions about the strain or perspiration of the socket user.

[0018] In one embodiment, a receptacle for the stiffening element, optionally an adjusting element and / or the adjusting device is arranged in the shaft wall or on the shaft wall, so that the adjusting element, the adjusting device or the stiffening element can be subsequently and / or replaceably fastened to or in the shaft wall.

[0019] In one embodiment, the socket wall surrounds the limb or limb stump over its entire circumference, thus providing a closed cross-section. This design with a circumferentially closed cross-section increases the overall structural strength of the socket, and the areas with adjustable stiffness allow for adjustments to meet comfort requirements.

[0020] The stiffening element and the adjustment device, or the adjustment element, the adjustment device, and the stiffening element, are combined in one embodiment as a stiffening module. This stiffening module can be arranged interchangeably on or in the socket wall to allow for the replacement of existing components, retrofitting, or adaptation to the specific user. The stiffening module can be industrially prefabricated and pre-tested with regard to applicable safety regulations, watertightness, and other requirements. The stiffening module can be reversibly and detachably attached to the socket wall, for example, using a form-fitting or force-fitting method.

[0021] The socket allows for the integration of industrially prefabricated, modular components into customized prosthetic or orthotic sockets. These components' stiffness can be reversibly adjusted, allowing the stiffness of the socket or socket wall to be customized at specific locations or in specific areas that can be individually selected. In orthoses, the term "socket" is also used for splints, shells, corsets, and / or a pelvic cage. Because individual contact surfaces in the socket can be reversibly adjusted in terms of stiffness, the overall characteristics of the socket can be adapted to suit the specific situation. With such a socket, it is no longer necessary to compromise between comfort and function, which is suitable for all usage situations and therefore generally does not offer optimal functionality in any situation.

[0022] In one embodiment, sectors with different radial elasticity are formed in a proximal edge region of the socket wall. The socket, particularly in a design as a prosthetic socket, surrounds the stump or limb essentially over its entire circumference. Viewed across the circumference, a socket can be divided into different sectors that perform different functions and are exposed to different loads during different activities or conditions. In a femoral socket, for example, this is a lateral sector, which is particularly crucial for lateral guidance and stability during loads towards the middle of the body. The anterior sector serves to support in the direction or load direction of the front region, the posterior sector for support in the opposite, rear region.A medial sector absorbs loads that are intended to move the socket away from the center of the body. In a femoral socket, the so-called ramus attachment in the area of ​​the ischium is added. In other types of socket, in particular, only the first four sectors mentioned are present; in principle, more or fewer sectors can be arranged or formed on the socket. Due to the different loads, types of load, directions of load, magnitudes of load, and frequencies of load, it is advantageous if the sectors are designed with different elasticity in the radial direction, so that socket wall sections of varying stiffness can be provided in the proximal edge region, which forms the upper end of the prosthetic socket and can extend approximately to the upper half or the upper third of the total length of the socket.Using the adjustment device and, if necessary, an adjustment element, the stiffnesses in the individual sectors can be adjusted or changed separately and independently of one another in any combination and in the required sizes.

[0023] The sectors can have different materials, different material thicknesses, different recess widths, and / or different recess densities. For example, if the stiffening elements are completely deactivated or set to the minimum resistance, different basic stiffnesses or basic resistances to radial displacement of the shaft can result due to the basic design in the proximal edge area. The different basic stiffnesses can be provided by different materials in the different sectors. If the same materials are used, for example, a plastic or a fiber-reinforced plastic, different material thicknesses can lead to different stiffnesses in the respective sectors.In addition to or as an alternative to the two aforementioned measures, recesses can be provided within the sectors to influence the stiffness of the respective section of the shaft wall. One possible design for the recesses is slots that are introduced in a proximal-distal direction. The slots can reach up to the upper end of the prosthetic shaft and, if necessary, extend in the distal direction to the end of the proximal edge area. The width of the recesses or slots can vary between the sectors or even within a sector. Likewise, the density of the recesses in the individual sectors can vary. The higher the number of recesses on a standardized circumferential length, the lower the stiffness; the greater the length of the recesses, the lower the stiffness, and the greater the width of the recesses, the lower the stiffness in the respective segment.

[0024] In one embodiment, displaceable shaft wall segments are assigned to the individual sectors as stiffening elements, which are actuated or displaced individually or in combination with one another in order to provide different stiffnesses in the proximal edge region.

[0025] In one embodiment, at least one flexible region is formed in the socket wall, which is coupled to a stiffening element. The flexible region always allows, for example, a displacement of the material within the flexible region radially inward towards the stump or limb. If the stiffening element is relaxed or not activated, the material of the flexible region can also be moved in the opposite direction, so that increased play or increased mobility of the limb or stump can be achieved in this sector. The stiffening element is, for example, a traction device such as a belt or a rope that is tensioned so that a displacement of the material radially outward, for example a foam or a textile, is not possible or only possible to a limited extent.A lack of or reduced radial outward flexibility is advantageous under high loads, such as during rapid performance of activities. Conversely, a relaxation of the traction mechanism is advantageous during periods of inactivity, for example, when no load needs to be absorbed and it is only necessary to ensure that the socket does not detach from the user's limb or residual limb.

[0026] The method for adjusting an orthopedic socket for the application and reception of a limb stump or a limb, wherein a socket with at least one socket wall is provided and the socket has a proximal entry opening, a distal end, and at least one fastening device arranged on the socket for securing at least one distal orthopedic component, provides that the stiffness of the socket wall is changed at least in certain areas via at least one adjustment device and a stiffening element. The situation-dependent or freely selected, reversible variability of the stiffness in certain areas results in the socket itself being adjustable in its mechanical properties, and that the situation-dependent adjustability provides optimal functionality.

[0027] In one embodiment, the stiffness is changed by displacing an adjustment element, adjusting, shifting, or changing a stiffening element arranged on or in the shaft wall, and / or by activating or deactivating the adjustment device. The stiffening element is changed, for example, by shifting, compressing, changing the angle of a support element, or inserting or removing material into the spaces between sections formed by the stiffening element.

[0028] In one variant, the stiffness can be changed by twisting a spring element, whereby the spring element provides different resistances to deformation depending on its orientation and alignment.

[0029] Alternatively or in addition to twisting a spring element, it can also be moved, for example into or out of an area that is fundamentally intended for changing the stiffness. If a spring element is pushed into the area, the stiffness increases; if it is moved out, the stiffness of the shaft wall in this area decreases. If the spring element is permanently present and is not to be removed from the respective area, the spring element can also be blocked so that the flexibility basically provided by the spring element is no longer available and the shaft wall is stiffened in this area. The stiffening element or the adjustment element can be moved, for example twisted, pushed in, pulled out or compressed.If a volume exists in the range of variable stiffness, the stiffness can be changed by filling or emptying this volume with a corresponding fluid and / or by changing the viscosity of a medium present in the volume. Regions can be heated or cooled to achieve a desired change by changing the temperature-dependent flexural stiffness. Stiffening elements can be positively engaged with one another, for example, by engaging and disengaging corresponding gears.

[0030] The stiffness can be changed based on sensor data, which is determined by at least one sensor and transmitted to a control device, which in turn activates or deactivates an actuator. The actuator then initiates the necessary actions to change the stiffness, for example, switching on a heater, activating a cooling system, twisting or displacing a stiffening element, or taking another measure to provide the desired area with the desired stiffness. In particular, the stiffness is changed by twisting, shifting, tensioning, locking, and / or activating an adjustment element or stiffening elements.

[0031] In a further development, the socket wall has sectors distributed around the circumference, whose stiffness can be adjusted independently of one another. In one embodiment, the change in stiffness occurs automatically during use of the orthopedic socket, advantageously in real time and / or depending on the movement situation in which the user finds himself, for example, the gait situation if the orthopedic device is designed for the lower limbs, in particular as a prosthetic leg. The data is recorded by sensors and transmitted to an evaluation and control device. Based on this sensor data and the evaluation, the adjustment device is activated, deactivated, or modulated to set the desired or required degree of stiffness.This makes it possible to set stiffnesses adapted to the respective situation, in particular divided into sectors for which adjustment is made in the proximal edge region to the needs or preferences of the respective user. The sensor data can originate from sensors arranged on the socket and / or arranged on or assigned to a component attached to the socket. For example, if a resistance device is part of the orthopedic device to which the orthopedic socket is attached, the sensors used to control the resistance device can also be used to detect loading situations. Based on the respective loading situations, not only the resistance can be adjusted, but also the stiffness in the respective sector of the socket can be changed.

[0032] Exemplary embodiments of the invention are explained in more detail below with reference to the accompanying figures. They show: Figure 1 - an overall view of a prosthetic leg; Figure 2 - a prosthetic stem in individual representation; Figure 3 - a schematic representation of a section through a shaft wall; Figure 4 - a top view of a prosthetic stem with a movable stiffening element; Figure 5 - two representations of a shaft edge section in different stiffness states; Figures 6a and 6b - Representations of a prosthetic shaft section with a movable stiffening element; Figures 7a and 7b - Representations of a shaft wall section with rotatable stiffening elements; Figure 8 - a sectional view of an elastic shaft wall section with a parallel damping element; Figures 9a and 9b - Representations of a shaft wall section with fillable and emptyable volumes; Figure 10- two sectional views with two stiffening elements; Figure 11 - longitudinally adjustable stiffening elements, Figure 12 - a schematic representation with a comb-like stiffening element; Figure 13 - a representation with a horizontally movable stiffening element; Figure 14 - a variant of the Figure 13 ; Figure 15 - a cross-sectional view of a shaft with magnetorheological fluid; Figure 16 - a sectional view through a shaft wall with a hydraulic stiffening element; Figures 17a and 17b - two representations with a stiffening element in accordion design; Figure 18 - a representation of foldable stiffening elements in different positions; Figure 19 - a prosthetic stem with a displaced stiffening element; Figure 20 - a shaft wall section with a tensionable stiffening element; Figure 21 - a design of a rotatable stiffening element; Figure 22 - a variant of the Figure 20 ; Figure 23 - a design of a shaft with a viscoelastic element with a magnetorheological fluid Figure 24 - a variant of the Figure 2 with adjustment device; Figure 25 - a variant of the Figure 6 ; Figure 26 - a variant of the Figure 25 ; Figure 27 - a design of a stiffening module; Figure 28 - a representation of a guide for stiffening elements; Figure 29 - a representation of a prosthetic socket; Figure 30 - a top view of a prosthetic stem; Figure 31 - possible circuits; Figure 32 - situations with different stiffnesses; Figure 33 - a control of the adjustment of the stiffness; Figure 34 - a representation of a prosthetic socket; Figure 35 - a detailed representation of an adjustment device; Figure 36 - Individual representations of components of an adjustment device; Figure 37- a side view of a variant of a prosthetic stem; Figure 38 - a variant of a prosthetic socket with removable stiffening elements; Figure 39 - a variant of a stiffening element with adjustment device and adjustment element; Figure 40 - a variant of the Figure 39 ; Figure 41 - a stiffening element as a toggle lever closure; Figure 42 - a top view of a variant of a prosthetic stem; and Figure 43 - two views of another variant.

[0033] In the Figure 1 A shaft 1 in the form of a prosthetic shaft with a fastening device 5 in the distal end region is shown. The fastening device 5 is designed as a so-called pyramid adapter and serves to attach a prosthetic knee joint 6, which is coupled to a prosthetic foot 8 via a lower leg tube 7.

[0034] In the Figure 2A schematic representation of a socket 1 in the form of a prosthetic socket with a socket wall 2, a proximal access opening 3, and a distal end region 4 is shown. In the illustrated embodiment, the distal end region 4 is closed and forms an end cap, at the distal end of which a fastening device (not shown) for a joint, for example a prosthetic knee joint or a prosthetic ankle joint, is arranged. The socket wall consists predominantly of a dimensionally stable material and is designed with a closed cross-section so that a limb stump can be accommodated within the volume enclosed by the socket wall 2.The limb stump can either be inserted directly into the prosthetic socket 1 and secured therein or by means of a so-called liner technology, in which a flexible and elastic prosthetic liner is locked by means of vacuum technology or a mechanical locking by means of a Pinlock.

[0035] On the lateral side, the prosthetic socket 1 is designed with a raised socket wall 2 to enable secure guidance; on the medial side, the socket wall 2 is cut out deeper to form the so-called ramus attachment. In a central region of the socket wall 2, a first region 10 is formed in which the rigidity of the socket wall 2 can be varied, for example via a fillable and drainable volume located in the hollow socket wall 2 there. Furthermore, in the region of the ramus attachment, a second region 10 is formed in the socket wall, the rigidity of which can be varied. Options for adjusting the rigidity in the illustrated regions 10 and in other regions are explained in more detail below.

[0036] Figure 3shows a first embodiment in the form of a schematic sectional view through a shaft wall 2 of a shaft with the proximal edge in the area of ​​the ramus attachment. The shaft wall 2 has a double spring in this area, the base point 11 of which is displaceably mounted. The displacement of the base point 11 can be effected by motor or magnets. A pneumatic or hydraulic displacement of the base point 11 is also provided in one embodiment. If the base point 11 is displaced downwards, the double spring is pretensioned in the area 10 and the stiffness in the area 10 changes. The stiffening element is the double spring, the stiffness of which can be influenced by changing the position of the base point 11 via an actuator (not shown) as an adjustment device or by manual adjustment via a lever or slider as an adjustment device.

[0037] A variant of the adjustment of the stiffness in the ramus system is in the Figure 4 shown, which shows a plan view of the proximal edge region of the shaft with the shaft wall 2 and the proximal entry opening 3. The proximal shaft edge is slotted and has bevels 35 that engage with a stiffening element 40. If the stiffening element 40 is moved to the right, for example via a cable that is wound up or via a gear drive, the bevels 45 of the stiffening element 40 are pressed against the bevels 35 on the shaft wall 2 and thus pushed upwards. At the same time, the wedges are pressed against the abutments 25 due to the force component acting in the circumferential direction, whereby an increase in the stiffness in this area 10 takes place. If the stiffening element 40 is moved to the left, the compliance in this area is increased.

[0038] Figure 5shows a variant of a shaft wall 2 with adjustable stiffness by rotating the stiffening element 40, for example via a motor as an adjusting device 30. The stiffening element 40 is moved in the direction of the shaft wall 2 via the adjusting device 30, which is mounted on the shaft wall 2. The adjusting device 30 is pivotally mounted proximally and distally on the shaft wall 2 and thereby causes the shaft wall 2 to curve more sharply in that area and to have a higher preload and thus greater stiffness. The stiffening element 40 can also be designed to be flexible and, by changing the contact pressure via the adjusting device 30, bring about a change in the stiffness in the shaft wall 2 at a point or across a surface in the area 10.The stiffening element 40 can be displaced by the adjusting device 30, for example, by a threaded drive, a spindle, a motor, or a lever. Fixation in the desired position is achieved, for example, by a self-locking thread or by clamping the stiffening element 40 in the desired position. The stiffening element 40 acts on the shaft wall 2.

[0039] Figures 6a and 6bshow a shaft wall 2 with a displaceably mounted stiffening element 40. The shaft wall 2 is designed in the region 10 with adjustable stiffness in the form of a double spring and has a displaceably mounted stiffening element 40 as an intermediate element, which serves to lock the individual layers of the double spring. Depending on the positioning and orientation of the stiffening element 40, a changed stiffness is achieved in this region. The stiffening element 40 can be adjusted motorically via an adjustment device 30 or manually.

[0040] The Figures 7a and 7b show a design of the shaft wall 2 in a proximal end region with a double spring with a rotationally adjustable single layer as stiffening element 40. In the Figure 6b different positions of the stiffening element 40 are shown. In the right illustration of the Figure 6bThere is a reduced stiffness compared to the left illustration. The left illustration shows the non-rotationally symmetrical shape of the stiffening element 40, which results in a special shape of the shaft edge in the twisted state. Here, too, different positions of the stiffening element 40 result in different stiffnesses of the shaft wall 2.

[0041] Figure 8shows the design of the shaft wall 2 with the stiffness-adjustable region 10 in the form of a single spring on which a damper element 12 is arranged. The wall region 10 pivots in the proximal end region, which is influenced by a longitudinal displacement of the damper element. The higher the resistance in the damper element 12, the higher the stiffness of the spring and thus the region 10 of the shaft wall 2. The damper element 12 can be designed as a hydraulic damper, pneumatic damper, or solid-state damper and is adjustable, for example, via a preload element or an adjustment device via which a valve is displaced. A solid-state damper can be compressed or relaxed via the preload device, whereby the deformation resistance can be increased or decreased.In this embodiment, the damper element 12 is the stiffening element that causes the change in the stiffness of the shaft wall 2.

[0042] In the Figures 9a and 9bA variant with fillable volumes is shown. The shaft wall 2 is double-walled, in particular in the form of an elastic double spring, and has stiffening elements 40 within the cavity between the two walls, which can be filled or emptied via a pump as an adjustment device 30. Depending on the degree of filling, the stiffness in the respective area changes. The pump can be designed as a hydraulic pump or as a pneumatic pump. The adjustment device 30 can be activated or deactivated manually or automatically. Automatic activation can occur, for example, based on sensor data, such as spatial position data, pressure data, or temperature data. The sensor data is made available to a control device, which evaluates the data and transmits an activation or deactivation command to the respective actuator.

[0043] In the Figure 10is a detailed view of a sectional view in plan view, in which the shaft wall 2 is divided into different shaft wall regions. An inner, continuous shaft wall region 21 extends around the circumference of a limb or limb stump (not shown). Parallel to this, on the outside of the continuous, inner shaft wall region 21, two outer shaft wall regions 22 are arranged, integrally formed in the illustrated embodiment. These outer shaft wall regions 22 extend over a certain height or a certain proximal-distal extent along the outside of the prosthetic shaft on the shaft wall. One or more movable stiffening elements 40 are also arranged on the shaft wall 2 and, in the illustrated embodiment, are designed as clamps or sliders, which are arranged on the inside of the inner shaft wall region 21 and on the outside of the outer shaft wall region 22.The stiffening elements 40 are used to variably assign the inner and outer shaft wall regions 21, 22. The stiffening elements 40 can also be arranged in the space between the outer and inner shaft wall regions 21, 22 and / or in grooves or guides in the shaft wall regions 21, 22. The two outer shaft wall regions 22 form a gap between them, so that only the inner shaft wall region 21 is available as the total material thickness of the shaft wall 2 in the radial extension. In the upper illustration of the . Figure 10The stiffening elements 40 are displaced as far apart as possible, so that a mechanical association and force transmission between the outer shaft wall region 22 and the inner shaft wall region 21 occurs in the region where the two shaft wall regions 21, 22 split. This increases the proportion of the inner shaft wall region 21 that alone contributes to providing stability or rigidity of the shaft wall 2. In the lower illustration, the two stiffening elements 40 are displaced toward one another, so that larger areas of the outer shaft wall regions 22 contribute to absorbing forces when the shaft wall 2 is loaded, thus increasing stability and increasing rigidity in this area.Several stiffening elements 40 spaced apart in the proximal-distal direction can be provided on the shaft wall 2 in order to provide different stiffnesses in the proximal-distal direction by varying the positioning of the individual stiffening elements 40. The stiffening elements 40 can be adjusted manually by displacement; alternatively, drives of an adjustment device can be assigned to the stiffening elements 40, for example, magnets, motors, pumps, or the like, in order to achieve a displacement along a displacement path. As an alternative to displacement of clamp-like or slider-like stiffening elements 40, these can also be designed as clamps that pull or push the outer shaft wall region 22 toward the inner shaft wall region 21, thereby causing a thickening and increase in the effective material thickness in this region.As an alternative to a circumferential displacement of the stiffening elements 40, they can also be designed to be displaceable in the proximal-distal direction. The shaft wall regions 21, 22 are, for example, elastically designed, so that the stiffness in this region can be changed by moving the stiffening elements 40 upwards and downwards along the longitudinal extent of the shaft 1.

[0044] Figure 11shows a variant in which shaft wall segments 23 are displaceable relative to one another along their longitudinal extent. The respective shaft wall segments 23 are mounted on one another in a foldable or pivotable manner and have corresponding bearing points, which in the illustrated embodiment are designed as clamps. The correspondingly shaped regions of the shaft wall segment 23 are pulled into this clamp or pressed out onto it, resulting in wedging of the shaft wall segments 23. The wedging can be achieved, for example, via a traction device or a push-pull rod as an adjusting element 20, which is displaceable along the longitudinal extent of the shaft wall segments 23.If the shaft wall segments 23 are displaced towards one another and wedged together, the rigidity increases; if a reverse movement is carried out or permitted, for example by relaxing a tension means against a spring force and the spring force or an elastic element presses the shaft wall segments 23 apart, an increased or easier pivotability of the shaft wall segments 23 relative to one another is permitted and thereby the rigidity of the shaft wall 2 is changed in some areas.

[0045] In the Figure 12A further variant is shown in which comb-like projections or incisions are arranged on the outside of the shaft wall 2. The rigidity and stability of the shaft wall 2 can be varied in the spaces between the prongs or projections using a stiffening element 40 that can be moved toward or away from the shaft wall 2. Corresponding spaces and prongs are arranged on the stiffening element 40, which can be inserted into or removed from the spaces between the prongs on the shaft wall 2. Depending on how far the stiffening elements 40 or prongs are inserted into the spaces, the rigidity in this area is increased or decreased.

[0046] A variant of the Figure 12 is in the Figure 13shown, in which the stiffening element 40 with the prongs or projections is not displaced radially outwards away from the shaft wall 2, but rather a horizontal displacement occurs along the outer surface of the shaft wall 2. The projections or block-like shoulders on the shaft wall 2 are brought into contact with or out of contact with the projections or shoulders of the stiffening element 40 by the displacement of, for example, an adjusting element by an adjusting device. Depending on the overlap and degree of filling of the spaces between the blocks on the shaft wall 2 by the stiffening element 40, the stiffness and dimensional stability of the shaft wall 2 in this area increases or decreases.

[0047] In the Figure 14A further variant is shown in which nubs with a dovetail-shaped cross-section are arranged or formed on the shaft wall 2. Correspondingly, projections with a dovetail shape are arranged on the stiffening element 40. Thus, both projections or nub-like elements on the stiffening element 40 and the shaft wall 2 have undercuts, whereby an improved force transmission can take place in the state in which the components are shown. The multiple wedge shape of the nubs or the form-locking elements makes it possible to activate the components more easily and to facilitate their insertion and engagement with one another. The wedge-shaped shape also makes it possible to achieve a movement-dependent stiffness jump.The upper illustration shows a section in the radial direction, the lower illustration shows the section along the line AA in the upper illustration, which corresponds to a section in the circumferential direction.

[0048] In the Figure 15A further variant is shown in which the shaft 1 is designed as a prosthetic shaft. The shaft wall 2 is hollow and has a magnetorheological fluid 40 as a stiffening element inside it. Electromagnets are arranged on the outside of the prosthetic shaft 1 as adjusting devices 30, which act on the fluid volume. When the electromagnet 30 is activated, the viscosity of the magnetorheological fluid 40 changes, thereby changing, in particular increasing, the stiffness in the respective area. The volumes within the shaft wall 2 can be separated from one another, so that different magnetorheological fluids can be used in separate volumes, so that structurally different viscosity changes and thus also stiffness changes occur with the same magnetic fields.The magnets 30 can also be controlled individually to provide magnetic fields with different field strengths, thereby providing different stiffnesses in the prosthetic socket 1 depending on the situation and location.

[0049] In the Figure 16A variant is shown in which the stiffening element 40 is designed as a cavity or cushion that is arranged as an intermediate layer between two shaft walls 2 or shaft wall sections. A reservoir 41, in which a fluid, for example a liquid, is arranged, is assigned to the cushion 40. Via a pump or by reducing the volume of the reservoir, for example by squeezing it together by hand or muscle activation, the fluid is moved from the reservoir 41 into the cushion 40 and held there. The shaft walls 2 can be designed to be elastic; when the cushion 40 is deflated, the stiffness is comparatively low, while when the cushion 40 is filled, it is increased. The stiffening element 40, optionally with a pump or embedded between two leaf springs instead of the shaft wall sections, can be prefabricated as a complete module and arranged and fastened on or in a shaft wall.Thus, the stiffening module can be attached either as an intermediate layer between two flexible shaft wall areas or to an outer side of the shaft wall 2.

[0050] A further design is in the Figures 17a and 17b shown. In the Figure 17a An exploded view of either a stiffening module or a shaft wall with two shaft wall regions 2 is shown, between which a stiffening element 40 is arranged in a wave-like or accordion-like shape. The stiffening element 40 is formed, for example, from a resilient sheet metal. An adjusting element 20 in the form of a traction means, for example, a wire or a cord, is associated with the stiffening element 40. Figure 17bThe adjustment device 30 is shown schematically in the form of a motor that drives a roller onto which the adjustment element 20 is wound. The right end of the stiffening element 40 is mounted in a stationary manner on a shaft wall region; the left end can be displaced to the right via the adjustment element 20. If the adjustment element 20 is wound via the adjustment device 30, the left end of the stiffening element is displaced toward the adjustment device 30, whereby the essentially straight sections between the bent or folded regions of the stiffening element are aligned more steeply, resulting in increased rigidity in this region. If the adjustment element 20 is released, the elastic restoring forces of the stiffening element 40 cause it to return to its original position, reducing the rigidity in this region of the shaft wall 2.

[0051] An alternative design is in the Figure 18 shown, in which, instead of an accordion-like design of the stiffening element 40, several foldable stiffening elements 40 are arranged between the wall sections. In the upper illustration, the region 10 of the shaft wall is stiffened or provided with increased rigidity, whereas in the lower illustration, with the wound-up adjusting element 20 and the adjusting device 30 as a motor drive, the stiffening elements 40 are inclined, which results in easier displacement of the shaft wall regions 2 relative to one another. The stiffening elements 40 are advantageously elastically mounted, so that after the removal of an adjusting force by the adjusting element 20, they return to their original position. The adjusting element 20 can also be designed as an element that transmits tensile and compressive forces in order to effect pivoting in both directions.

[0052] In the Figure 19 In one variant, a prosthetic socket with two regions 10 whose stiffness can be varied is shown. In addition to a flat functional region 10 in the center of the prosthetic socket 1 within the socket wall 2, a stiffening element 40 is arranged on the so-called ramus attachment at the proximal edge in the area of ​​the entry opening 3, which can be moved either manually or via an adjustment device (not shown). The stiffening element 40 is moved from the initial position shown in the left illustration to the relief position shown in the right illustration, so that an entire region 10 at the upper edge of the socket changes in terms of stiffness. In the upper region, the stiffness of the prosthetic socket 1 is reduced, for example, to make sitting more comfortable for a socket user.

[0053] In the Figure 20A further embodiment is shown in which stiffening of the shaft wall 2 is achieved via a stiffening element 40 designed as a tension element. If the stiffening element 40, which is fixed to the shaft wall 2 at a fastening point 27, is tensioned on the outside via knobs or elevations guided by grooves or ridges, the overall stiffness of the shaft wall 2 increases in this state. Once set, the tension can be fixed within the adjustment element 20 via a clamping device 26. If the tension element or the stiffening element 40 is released, the prestress of the shaft wall region in which the tension element is effective is modulated and reduced, whereby the overall stiffness of the region is reduced again.

[0054] In the Figure 21Two different orientations of a stiffening element 40 are shown, which consists of two parts 28, 29, each having different strengths or stiffnesses. The left half 28 consists of a soft, flexible material, while the right half 29 in the left illustration consists of a firm, less flexible material. If a force F is exerted on the stiffening element 40 from above, for example, different compliances and stiffnesses result depending on the position and orientation of the two halves relative to one another. In the left illustration, the two halves act like spring elements arranged parallel to one another. Due to the orientation of the cutting plane in the middle of the stiffening element 40 parallel to the direction of the force, a high level of stiffness or strength and a high resistance to displacement results, which is indicated by the short double arrow.A 90° rotation relative to the direction of force F, as shown in the right-hand illustration, results in lower bending resistance and thus lower strength in the area in which the stiffening element 40 is arranged. The rotation relative to the respective force direction can be performed manually, by motor, or by another drive.

[0055] In the Figure 22 is a variant of the Figure 20, in which a tensioning means is also arranged as a stiffening element 40 on an adjusting device 30, for example, a roller. The adjusting device 30 can be manually or motor-driven and can be displaced in one direction or the other based on a switch command or sensor data. The end of the stiffening element 40 facing away from the adjusting device 30 is mounted on a projection on the shaft wall 2 and forms an abutment, so that by winding or unwinding the tensioning element, an increased or decreased tension and preload is achieved in this area.

[0056] In the Figure 23A variant with a stiffening element 40 in the area 10 of the shaft 1 is shown schematically. The prosthetic shaft 1 is fundamentally elastic in this area and has an inlay or stiffening element 40 with magnetorheological properties. The right-hand illustration shows two states of the stiffening element 40; the left-hand illustration shows a non-polarized state in which the stiffening element 40 is very flexible. In the right-hand illustration, the magnetorheological fluid is polarized and, due to the increased viscosity, will offer greater resistance to stress. This makes it possible for forces in this area to be subjected to greater deformation resistance. When the load and polarization are removed, the shaft wall 2 of the prosthetic shaft 1 returns to the starting position originally set by the orthotist.

[0057] In the Figure 24 A stiffening module is shown on the shaft wall 2 with a motor-driven adjustment device 30, on which an adjustment element 20 is mounted via a crank mechanism. Depending on the direction of rotation, it is possible to displace the adjustment element 20 toward the proximal shaft edge or, in the opposite direction, in the distal direction. A stiffening element 40 is arranged on the adjustment element 20 and is mounted, for example, in a guide for displacement on the shaft wall 2. The region 10 of the shaft is generally designed to be flexible and can be stiffened by displacing the stiffening element 20 upward, thus providing increased flexural rigidity.

[0058] In the Figure 25 is a variant of the Figure 24shown, in which the stiffening module is replaceably attached to the shaft wall 2. Alternatively, the stiffening module can also be arranged without the adjustment device 30 with the movable adjustment element 20 and the movable stiffening element 40 fixedly on the outside or inside the shaft wall 2. By rotating the adjustment device 30, the adjustment element 20 and the stiffening element 40 are displaced via the crank mechanism, and the stiffness of the fixed stiffening module in this area is changed.

[0059] In the Figure 26 A further embodiment is shown, which is essentially the same as the Figure 25 In addition to the adjustment device 30 with the stiffening element 40, which is slidably mounted along the outer wall of the prosthesis shaft, Figure 26A control device 60 is shown, which is coupled to at least one sensor 70. The coupling can be wireless. Alternatively or additionally, coupling of the sensor 70 or sensors 70 via a cable or another conductive connection is possible and provided. The necessary components for processing the sensor signals are housed within the control device 60, in particular a memory component 61, a data processing device 62, and a communication interface 63. The communication interface 63 can send data to or receive data from external devices and forward it to the data processing device 62, for example, a processor, for processing.In addition, the other necessary components are also integrated in the control device 60 or coupled thereto, for example an energy storage device, possibly amplifiers or other electrical, electronic or electromechanical components.

[0060] The control device 60 transmits the necessary activation and / or deactivation signals to the adjustment device 30, which is coupled to an actuator 80, which in the illustrated embodiment is embodied as an electric motor. Transmission can also occur via the communication interface 63. The actuator 80, for example, displaces a rotary disk of the adjustment device 30 in one direction or the other, so that the adjustment element 20, in the form of a push rod, displaces the stiffening element 40 in one direction or the other to effect a change in the stiffness of a region 10 of the shaft wall 2.

[0061] In the Figure 27A further variant is shown in which all components for changing the stiffness of the shaft wall 2 are combined in a stiffening module. The stiffening module has a housing that can be reversibly secured to the outside of the shaft wall 2 using screws, rivets, or other fastening elements. The stiffening module can also be embedded in the shaft wall 2 or integrated into the shaft wall 2. The housing of the stiffening module simultaneously serves as a guide for the stiffening element 40, which in the illustrated embodiment is designed as a longitudinally displaceable stiffening component, for example, as a slider, a deformable strip, or a spring. Depending on how the actuator 80 displaces the adjustment device 30 with the adjustment element 20, the stiffening element 40 is pushed upwards or pulled downwards, thereby changing the stiffness in the proximal shaft wall region 10.

[0062] In the Figure 28A total of four stiffening elements 40 are arranged in guides 90 on the outer side of the shaft wall 20. The stiffening elements 40 can be moved upwards or downwards, either manually or via an actuator (not shown). The further the stiffening elements 40 are moved upwards, the stiffer the proximal shaft wall region 10 is, which can also be subsequently inserted into the shaft wall 2 and fastened thereto. For this purpose, a corresponding recess is machined into the shaft wall 2 or is introduced into it, and the shaft wall region 10 is then fastened, in particular permanently, to the shaft wall 2, for example via form-fitting elements, fastening elements or also by means of a material fit via welding, gluing or the like. The shaft wall region 10 has slots between each individual stiffening element 40 so that the stiffness of the respective regions can be changed separately from one another.

[0063] In the Figure 291 shows a further embodiment of the prosthetic shaft 1, which has a circumferential shaft wall 2 and a distal end region 4. The distal end region 4 and the continuous shaft wall 2 form a substantially rigid, sleeve-shaped prosthetic shaft 1, in the proximal edge region 9 of which recesses 24 are partially formed, extending from the proximal shaft edge in the distal direction. The prosthetic shaft 1 is divided into a total of five sectors 25, with a first, lateral sector 25 L having no recesses 24. The other four sectors are an anterior sector 25 A, a medial sector 25 M, a posterior sector 25 P and a sector 25 R for the ramus attachment. In the illustrated embodiment, all other sectors 25 A, 25 M, 25 R and 25 P have recesses 24 except for the lateral sector 25 L.The recesses 24 can be of different widths, densities, and / or lengths depending on the sector. The longer the recesses 24 extend in the distal direction, the more flexible the proximal edge region 9 is in this sector. The same applies to a greater width of the recesses 24 as well as an increased or high number of recesses 24 per circumferential length. Since the lateral sector 25L is primarily responsible for lateral guidance and stability, and adjustable flexibility or elasticity is not necessary there due to the usual movements with a prosthetic socket, in most cases there are no recesses in the lateral sector 25L. Alternatively or in addition to the recesses 24, different material thicknesses can be present in the individual sectors in order to be able to adjust the flexibility or elasticity of the socket entry plane or in the proximal edge region 9.In the lower right corner of the . Figure 29 A top view of the prosthetic socket with the individual sectors 25 is shown. The orientation and naming are determined by the direction of walking. In the illustrated embodiment, a prosthetic socket 1 for a left stump is shown.

[0064] The individual sectors 25 A, 25 M, 25 R, 25 P, and optionally 25 L are individually designed to allow for variable stiffness. It is particularly advantageous to design only the proximal shaft wall region 9 with flexible and switchable stiffness in order to provide sufficient rigidity and stability in the remaining region. The division and dimensioning of the respective sectors can be customized. An example of a sector division is shown in the Figure 30shown, in which a prosthetic stem is shown in plan view. The first reference point A is the intersection point for the diagonal measurement and the lateral anterior-posterior bearing and forms the anterior end of the lateral sector 25 L. The diagonal measurement is the measurement from the ramus grasp to the greater trochanter. The reference point B is the intersection point of the anterior edge of the perineum and the medial anterior-posterior abutment, the anterior sector 25 A lies between the reference point A and the reference point B. The reference point C lies at the ramus exit at the transition to the perineum in front of the adductor support, between the reference points B and C lies the medial sector 25 M. The sector 25 R for the ramus attachment lies between the reference point C and the reference point D, which forms the posterior edge of the ramus grasp. The posterior sector 25 P is located between the reference point D and the reference point E, which is mirrored to the reference point fixed at the running direction.The lateral sector 25 L lies between the reference points A and D.

[0065] In the Figure 3111 different options for switching the stiffening elements (not shown) via an adjustment device or the adjustment devices are shown. Starting at the top left and moving clockwise, there is complete stiffening or maximum stiffening of the individual sectors, resulting in a fully or maximally stiffened prosthetic socket in the proximal edge region. If the stiffness in the anterior sector 25 A is reduced, the rigidity in this area is reduced. In order to continue to guide the stump in this area and to prevent a part or area of ​​the stump from becoming trapped when switching from increased compliance to increased stiffness, the sectors to be stiffened or the proximal edge region to be stiffened are provided with an inner socket 26 which is designed to be flexible.The inner shaft 26 can be cup-shaped with a distal closed region or can be arranged on the shaft wall only in the region of the proximal edge region. Increased compliance in the rear region is created by reducing the stiffness in the posterior sector 25 P. When the compliance in the medial sector 25 M is changed, the corresponding stiffening elements in this sector are activated or deactivated accordingly by the adjustment device. Correspondingly, the stiffness is completely released or maximally reduced by changing or selectively switching the stiffness in the ramus system in sector 25 R. There are two possibilities for this, as shown in the last illustration in the top row of the . Figure 31the stiffness in the sector of the ramus system 25 R is minimized and the inner shaft or the lining is not present or is particularly flexible, so that almost completely free mobility can be achieved; in the penultimate illustration in the upper row, the stiffness in the sector 25 R is reduced, but the inner shaft is still present.

[0066] If several sectors are set to be flexible, for example, the anterior sector 25 A, the medial sector 25 M, the sector 25 R for the ramus attachment, and the posterior sector 25 P, maximum flexibility of the prosthetic stem 1 is present, at least in the proximal edge region 9, since only the lateral sector 25 L in the proximal edge region 9 still has the original, maximum stiffness. It is also possible to reduce the stiffness in three sectors, for example, the anterior sector 25 A, the medial sector 25 M, and the sector 25 R for the ramus attachment.

[0067] Alternatively, only two sectors can be selectively modified or reduced in terms of stiffness, for example the medial sector 25 M in conjunction with the posterior sector 25 P, the medial sector 25 M with the sector 25 R for the ramus attachment, or for a lateral edging the anterior sector 25 A and the posterior sector 25 P.

[0068] In the Figure 32Some examples of situations are shown in which the respective sectors can be adjusted accordingly in terms of stiffness. The setting can be different for each person; in addition to a purely binary switch between "stiff" and "compliant," different stiffnesses within the sectors can be provided for different gait situations or usage situations. When sitting and standing, the illustrated embodiment provides that, with the exception of the lateral sector, which is not adjustable in this embodiment, all other sectors are set to a reduced stiffness. When walking or walking quickly, the four other sectors have an increased or maximum stiffness, as does walking on uneven terrain.For walking around curves, the medial sector 25 M is set to be flexible; when walking uphill, all sectors are stiffened again; when walking downhill as well as when climbing stairs, the posterior sector 25 P is set to be soft; when walking downstairs, all switchable or adjustable sectors are provided with reduced flexibility or increased stiffness.

[0069] The setting of the different modes or stiffnesses in the area of ​​the shaft entry plane in the proximal edge area 9 is in the Figure 33shown as an example. Two different modes are provided for four situations, for example sitting, standing, walking and going upstairs: the comfort mode, which is shown in the top line, and the sport mode shown below. Both modes can be changed manually via an input device 75, so that each patient can find the setting they find most comfortable in every situation. Switching between a comfort mode and the sport mode can occur automatically or by manual switching using the input device 75. The user's movements are continuously monitored by the sensors in order to automatically detect changes in usage behavior or different movement situations.Monitoring is performed via sensors that can be present in the prosthetic stem 1 as well as in the other prosthetic components 6, or only in the other prosthetic components. The stiffness of the sectors in the proximal edge region or the stiffness of the entire proximal edge region is advantageously adjusted in real time in order to always provide an adapted stiffness of the prosthetic stem 1.

[0070] An example of how to adjust sector-wise or area-wise stiffnesses in the shaft entry plane or in the proximal edge area is shown in the Figure 34shown, in which three representations of an embodiment of a prosthetic socket 1 are shown. The prosthetic socket 1 has an inner socket 26 which completely surrounds the stump (not shown), on the outside of which inner socket or in which a cable pull system with four cables is arranged in grooves or channels. The cables are the adjustment elements 20, which are actuated by a central adjustment device 30 on the outside of the socket wall 2. Each of the four cables is arranged so as to encircle or at least partially encircle the prosthetic socket and has a fixed end and an adjustable end on the adjustment device 30. Each cable is guided in such a way that it activates exactly one socket wall segment as a stiffening element 40. Each socket wall segment is designed as a shell and is arranged on the outside of the prosthetic socket 1, corresponding to a respective sector.In the illustrated embodiment, four socket wall segments 40 A, 40 M, 40 R, 40 P are positioned, i.e., anteriorly, medially, in the area of ​​the ramus attachment, and posteriorly. The adjustment device 30 is attached to a lateral area of ​​the prosthetic socket 1. The prosthetic socket 1 is sufficiently stable to allow a cable guide on it or in it, which, when the cable is tensioned, results in no change in the inner circumference or only a negligible reduction or deformation of the interior of the prosthetic socket 1. When a cable pull 20 is tensioned, the respective socket wall segment 40 A, 40 M, 40 R, 40 P, along whose outer side the cable pull 20 is guided as an adjustment element, is pulled towards the stump and prevents or reduces a lateral outward deformation of the prosthetic socket 1 in this area. Up to the respective shaft wall segment and thereafter, the respective rope runs decoupled from the shaft wall segment, e.g.The cable runs inside the shaft wall or on the outside between the prosthetic shaft and the inside of the shaft wall segment.

[0071] In the left illustration of the Figure 34 The shaft wall segments 40 or shells are distally connected to the prosthetic shaft 1 in an articulated manner, for example via a textile or a joint 42. If the respective shaft wall segment 40 A, 40 M, 40 R, 40 P is unlocked, it can lift itself to a limited extent from the shaft wall of the prosthetic shaft 1, so that it is possible for the prosthetic shaft to yield flexibly, in particular elastically, in the proximal edge region 9. In the middle illustration of the Figure 34It is shown that the prosthetic socket 1 is provided on the outside and distal to the lateral sector 25 L with the adjustment device 30, from which the four cables are guided circumferentially around the prosthetic socket, at least as far as behind the socket wall segment to be moved. A posterior socket wall segment 40 P and the socket wall segment 40 R for the ramus attachment are shown, the socket wall segment 40 R is detached. Due to the joint 42 in the distal region of the socket wall segment, which is designed as a textile or other solid body joint, the socket wall segment 40 R can be displaced radially outwards from the rest of the prosthetic socket, so that the respective region of the prosthetic socket with the sector 25 R and optionally an inner socket can be displaced outwards more easily when loaded by the stump than with an attached socket wall segment.The right illustration shows the two other segments, an anterior shaft wall segment 40A and a medial shaft wall segment 40M, both of which are located on the outside of the prosthetic shaft 1 with the segments and recesses 24.

[0072] The socket wall segments 40A, 40M, 40P and 40R form part of an outer shell of the prosthetic socket and are adjusted via the central adjustment device 30, which is located in the Figure 35are shown enlarged, are actuated via the cables. In the illustrated embodiment, the cables as adjustment elements 20 are pre-tensioned by springs 34 and can be unlocked or locked via an actuator 32. The springs 34 keep the cables 20 taut on the socket. If a cable 20 is unlocked, the socket wall segment that is coupled to the cable can be pivoted outwards. In the outwardly pivoted position, in which the spring 34 is tensioned, the cable can be locked so that permanent loosening and thus a reduction in stiffness in the sector to which the respective segment is assigned is achieved. If the locking is released, the spring 34 contracts again and moves the socket wall segment in the direction of the stump.In the maximum shortened position of the springs 34, the effective length of the cable is shortened to its maximum, so that the connected shaft wall segment is maximally compressed. If the cable is locked in this position, the maximum stiffness is set in the corresponding segment in the proximal end region.

[0073] In the Figure 36Two embodiments for the release or locking of the respective cable pull or spring tension are shown. In the upper illustration, a tension spring 34 acts on the cable 20, to which balls 33 or projections are attached, which engage with a locking element 31. The locking element 31 is designed as a pivotable lever, which can be moved via an actuator 32, for example a magnetic switch or the like, from a release position, which is shown, into a locking position, which is indicated by the arrow, and back. An alternative variant is shown in the lower illustration of the Figure 36 in which a locking element 31 is moved downwards from the illustrated release position into a locking position in order to block the balls 33 or projections from moving in the direction of the longitudinal extension of the cable 20 or along the force action of the spring 34.

[0074] In the Figure 37A further variant of the prosthetic socket 1 is shown, in which flexible regions 43 in the proximal edge region are used together with rigid socket wall segments 40M pivotally attached to the distal, closed prosthetic socket in order to achieve different stiffnesses in the proximal socket wall region. In addition to the rigid lateral sector 25L, one embodiment provides flexible sectors 43 in the anterior sector and the posterior sector, which can be switched between a flexible behavior and an elastic behavior via cables or other adjustment elements 20. Flexible regions 43 in the socket entry plane or in the proximal edge region offer inward-directed flexibility. The adjustment elements 20 in the form of cables are arranged within the flexible regions 43 and can be tensioned or relaxed.In the tensioned state, the corresponding sector with the flexible area 43 is flexible inward and cannot be displaced outward. In a relaxed state, there is also radial outward flexibility to adapt the wearing behavior to the user's specific needs. Such flexible areas 43 can be combined with the rigid shaft segments, which are determined based on the... Figure 34 explained above.

[0075] In the Figure 38An embodiment of a prosthetic socket 1 with a rigid distal end region and four socket wall segments 40 is shown. These are rigid and can be mounted and dismounted on the outside of the prosthetic socket 1 via quick-release fasteners 44 on the socket wall 2. An inner socket 26 is arranged on the inside of the prosthetic socket 1 to provide a smooth-walled inner surface for receiving a stump. The lateral sector is rigid and integrally formed on the distal end region 4; the other socket wall segments 40A, 40B, 40R, 40P can be attached separately to the prosthetic socket and change the rigidity in the respective area.

[0076] In the Figure 39A schematic detailed representation of a further embodiment of the prosthetic socket with a socket wall 2 is shown, to which an adjustment device 30 is coupled as an actuator with an adjustment element 20. The adjustment device 30 moves the adjustment element 20 up or down in the direction of the arrow and acts on pivotally mounted stiffening elements 40 arranged one behind the other in the proximal-distal direction. In the left-hand representation, the stiffening elements 40 do not rest against one another and allow mobility to the right or outwards until the time or state at which all stiffening elements 40 rest against one another. In the middle representation, the adjustment element 20 is displaced downwards so that the distance between the stiffening elements and the possible displacement path for the socket wall 2 is increased, so that the socket wall 2 can be displaced further outwards with the upper, wedge-shaped contact element.In the right representation of the . Figure 39 The adjustment element 20 is in the maximum proximal position, so that all stiffening elements 40 abut one another in this position and also abut the wedge-shaped contact element. Movement to the right or radially outward is thus prevented or at least made more difficult.

[0077] In the Figure 40A variant of this scale-like design is shown, in which the stiffening element 40 assigned to the adjusting element 20 is designed as a double-armed lever, which rests on one side of the lever on the subsequently arranged stiffening element 40 and is changed in its position on the other side by the wedge-shaped adjusting element 20. Maximum stiffening is achieved when the adjusting element 20 has been displaced as far as possible in the direction of the first adjusting element 40 by the adjusting device 30. All subsequent stiffening elements 40 then rest on one another and press the proximal contact element downwards, resulting in maximum stiffening. If the adjusting element 20 is displaced to the left, there is correspondingly more play and flexibility in the system constructed as a module.

[0078] In the Figure 41A further embodiment of the orthopaedic shaft is shown in a detailed view, in which a stiffening element 40 is arranged on the shaft wall 2, which is designed as a toggle lever. In the left illustration of the Figure 41 The two-part stiffening element 40 rests against a stop on the outside of the shaft wall 2 and prevents, or at least significantly hinders, a further displacement of the proximal shaft edge in the case of a radially outwardly acting load, in the illustrated embodiment a load acting to the right. In the right-hand illustration in the Figure 41The stiffening element 40 is tilted outward beyond the pressure point, with the central contact point on the contact element being moved away from it, for example, by motor means via an adjustment device not shown. If a radially outward force then acts on the proximal shaft wall, the two elements of the toggle lever shift around the bearing located in the center, enabling deformation of the prosthetic shaft in this area or facilitating it due to the reduced stiffness.

[0079] In the Figure 42 is shown in a sectional view in plan view of the prosthetic socket 1 with the prosthetic socket wall 2. On the inside, an inner socket 26 is arranged, which completely surrounds the stump radially. The basic structure of the prosthetic socket 1 corresponds to that of the Figure 34, in principle, other embodiments are also possible. In a shaft wall sector, in the illustrated embodiment in the anterior shaft wall sector, lamellae are arranged which overlap one another. Due to the overlap of the lamellae, which form the stiffening elements 40, it is possible to manipulate the stiffness over the entire area or within the entire shaft wall sector by manipulating a single lamella. For example, if the central lamella is made stiff, for example with a stiffening element as shown in the Figures 17 and 18As shown, this stiffening element also blocks outward bending of the adjacent slats. Alternatively or in addition to stiffening the individual slats, it is possible and intended that the contact point of the slats can be changed reversibly using sensors. For example, the static friction in the overlapping areas and contact areas of the individual slats is changed reversibly. If relative movement of the individual slats to one another is prevented, for example by means of intermediate elements with different adhesive strengths, by temporarily covering adhesive intermediate elements or by electromagnetic blocking of the slats in the overlapping area of ​​the slats, the entire slat assembly made up of the overlapping slats is stiffened and thus serves as a stiffening element.

[0080] In the Figure 43A further embodiment of the prosthetic socket 1 with a socket wall 2 is shown, in which a closed distal end region 4 is also formed, on which fastening devices (not shown in detail) for orthopedic, in particular prosthetic, components are arranged or formed. Within the socket wall 2, a window or cutout 46 is present, in the illustrated embodiment in the anterior region, which is filled with a material or to which a cover is attached, in order to provide a circumferentially closed socket wall 2 up to the proximal end region. At the proximal end of the cutout 46, a flap is pivotably arranged as a stiffening element 40. The flap is in the left illustration of the Figure 43opened, so that the inner socket 26, which is designed as a lamella in this area, can be easily displaced outwards. The inner socket 26 does not have to be designed as a lamella. In the right-hand illustration, the stiffening element 40 is displaced via the adjustment device 30 and the adjustment element 20 into the closed position, moved in the direction of the stump (not shown). In this position, the prosthetic socket 1 is essentially rigid even in the proximal edge area, since the adjustment element 20 is designed as a cable pull or belt, flexible and essentially tensile-resistant. The remaining socket wall 2 is rigid or rigid. In a variant of the Figure 43The shaft wall 2 is designed without an inner shaft 26 behind it, so that the outwardly displaced flap acts as a stiffening element 40, increasing the circumference of the prosthetic shaft 1 in the proximal edge region and thereby minimizing the stiffness in this sector or area. The shaft wall 2 in this area above the cutout 46 is displaceable and reduces the stiffness there to a minimum. The cutout 46 then extends to the upper, proximal edge and forms a window in the proximal edge region, which can be closed or opened by the flap as a stiffening element 40. List of reference symbols

[0081] 1 -Sock 2 -Sock wall 3 -Access opening 4 -Distal end area 5 -Fastening device 6 -Prosthetic knee joint 7 -Lower leg tube 8 -Prosthetic foot 9 -Proximal edge area 10 -First area 11 -Foot point 12 -Dampering element 20 -Adjustment element 21 -Inner socket wall area 22 -Outer socket wall area 23 -Sock wall segment 24 -Recess 25 -Sector 26 -Inner socket 27 -Sock wall segment 28 -First part 29 -Second part 30 -Adjustment device 31 -Locking element 32 -Actuator 33 -Ball 34 -Spring 35 -Bevel 40 -Stiffening element 41 -Reservoir 42 -Joint 43 -Flexible area 44 -Quick fasteners 45 -Bevel 46 -Cutout 60 -Control device 61 -Storage component 62 -Data processing device 63 -Communication interface 70 -Sensor 80 -Actuator 90 -Guide

Claims

1. An orthopedic socket for bearing on and for receiving a limb stump or a limb, having - at least one socket wall (2), - a proximal access opening (3), - a distal end (4), and - at least one fastening device (5) which is arranged for fastening at least one distal orthopedic component (6) to the socket (1), characterized in that at least one stiffening element (40) is arranged or formed on or in the socket wall (2), which stiffening element (40) is assigned an adjustment device (30) and by means of which a stiffness of the socket wall (2) is reversibly variable at least in certain regions.

2. The orthopedic socket as claimed in claim 1, characterized in that the stiffening element (40) is mounted displaceably in or on the socket wall (2).

3. The orthopedic socket as claimed in claim 1 or 2, characterized in that the adjustment device (30) is arranged on or in the socket wall (2).

4. The orthopedic socket as claimed in one of the preceding claims, characterized in that the stiffening element (40) is coupled to the adjustment device (30) via an adjustment element (20), and the adjustment element (20) is designed as a gear wheel, roller, crank, lever, tension means, rotary element, piston, thrust means or valve.

5. The orthopedic socket as claimed in one of the preceding claims, characterized in that the adjustment device (30) is designed as an electromagnet, pump, electric motor, heater, cooling element, piezoelectric element, electroactive polymer, force accumulator or manually operable device.

6. The orthopedic socket as claimed in one of the preceding claims, characterized in that the stiffening element (40) is designed as a fluid volume, shape memory element, corrugated body, accordion element, toothed body, spring, foam body, phase change material, folding element, damper or electro-adhesion element.

7. The orthopedic socket as claimed in one of the preceding claims, characterized in that the adjustment device (30) has an actuator (80) which can be activated and deactivated via a control device (60) assigned to it, which control device (60) is coupled to at least one sensor (70) or switch and activates or deactivates the actuator on the basis of sensor data or a switch operation.

8. The orthopedic socket as claimed in claim 7, characterized in that the at least one sensor (70) is designed as a temperature sensor, acceleration sensor, IMU, spatial position sensor, inclination sensor, force sensor, optical sensor, conductor electrode, pressure sensor, DMS or resistance sensor.

9. The orthopedic socket as claimed in claim 7 or 8, characterized in that the control device (60) is assigned a memory (61), a data processing device (62) and / or a communication interface (63).

10. The orthopedic socket as claimed in one of the preceding claims, characterized in that a receptacle (90) for the adjustment device (30) and / or the stiffening element (40) is arranged in or on the socket wall (2).

11. The orthopedic socket as claimed in one of the preceding claims, characterized in that the stiffening element (40) and the adjustment device (30) or the adjustment element (20), the adjustment device (30) and the stiffening element (40) are combined as a stiffening module.

12. The orthopedic socket as claimed in one of the preceding claims, characterized in that sectors (25) with different radial elasticity are formed in a proximal edge region (9) of the socket wall (2).

13. The orthopedic socket as claimed in claim 12, characterized in that the sectors (25) have different materials, different material thicknesses, different widths of recesses (24) and / or a different density of recesses (24).

14. The orthopedic socket as claimed in claim 12, characterized in that the individual sectors (25) are assigned displaceable socket wall segments (40A, 40M, 40R, 40P) as stiffening elements (40).

15. The orthopedic socket as claimed in one of the preceding claims, characterized in that at least one flexible region (43) is formed in the socket wall (2) and is coupled to a stiffening element (40).

16. A method for adjusting an orthopedic socket for bearing on and for receiving a limb stump or a limb, the socket having at least one socket wall (2), a proximal access opening, a distal end, and at least one fastening device which is arranged for fastening at least one distal orthopedic component to the socket, characterized in that the stiffness of the socket wall (2) is reversibly changed at least in certain regions via at least one adjustment device (30) and a stiffening element (40).

17. The method as claimed in claim 16, characterized in that the stiffness is changed by moving an adjustment element (20), changing the stiffening element (40), which is arranged on or in the socket wall (2), and / or activating or deactivating the adjustment device (30).

18. The method as claimed in either of claims 16 and 17, characterized in that the change of stiffness takes place on the basis of sensor data which are determined by at least one sensor (70) and transmitted to a control device (60), which activates or deactivates an actuator (80) of the adjustment device (30).

19. The method as claimed in one of claims 16 to 18, characterized in that the stiffness is changed by twisting a spring element, moving a spring element, blocking a spring element, displacing at least one stiffening element (40), filling or emptying a fluid volume, changing the viscosity of a medium, heating, cooling, positively engaging at least one stiffening element (40), wedging at least one stiffening element (40) and / or twisting at least one stiffening element (40).

20. The method as claimed in claim 17, characterized in that the stiffness is changed by twisting, shifting, tensioning, blocking and / or activating the adjustment element (20).

21. The method as claimed in one of claims 16 to 20, characterized in that the socket wall (2) has sectors (25) which are changed independently of one another in terms of their stiffness.

22. The method as claimed in one of claims 18 to 21, characterized in that the change in stiffness during the use of the orthopedic socket (1) takes place automatically, in particular in real time and / or as a function of the movement situation.