Set with device and method for making prosthetic sockets from UV-curable resin material

Abstract

The invention relates to a set for use in taking a cast of a limb stump (KS), in particular a lower leg stump, or in producing a prosthetic socket or part of a prosthetic socket, where the set comprises or consists of a medical device (100), at least one energy source and a deformable material that is hardenable by the energy source. In this case, the medical device (100) comprises at least one pressure vessel (1) with a fluid or pressure chamber (DK) for receiving or storing a fluid (F), the pressure vessel (1) comprising a wall (3) made of a first material and a liquid-tight membrane (5) made of at least a second material, and further comprising an insertion opening (9) for inserting the limb stump (KS) into the interior (I) of the pressure vessel (1). The membrane (5) is arranged to form or delimit the fluid or pressure chamber (DK). The energy source is used to harden or partially harden the deformable material to achieve a cast of the limb stump (KS) or to produce a prosthetic socket.

Description

[Technical field]

[0001] The invention relates to a set according to claim 1, a method according to claim 31, and a prosthetic socket or part thereof according to claim 38, as well as a membrane according to claim 39, and further to a material according to claim 40 and a kit according to claim 53, or the preamble or generic term of each of these claims. The invention further relates to a liner as disclosed herein.

[0002] Amputees may regain mobility using prosthetic limbs. Modern prosthetic limbs include a variety of modules that include a prosthetic socket.

[0003] The present invention relates to the technical field of making prosthetic sockets for prosthetic limbs or preferably for lower limbs, i.e. for prosthetic legs, in particular for transtibial prostheses. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] International Publication No. 2016 / 135320 Summary of the Invention [Problem to be solved by the invention]

[0005] The object of the invention is to propose a set with medical instruments for use in taking the impression of a prosthetic socket, in particular for the lower limbs, or at least in the manufacture of an inner or outer socket of a prosthetic socket. [Means for solving the problem]

[0006] The object of the invention may be achieved by a set with the features of claim 1. It may also be achieved by a method with the features of claim 31, a prosthetic socket with the features of claim 38 and a membrane with the features of claim 39. A material with the features of claim 40 and a kit with the features of claim 53 may also serve to achieve the object according to the invention.

[0007] According to the invention, a set is proposed for use in taking an impression of a limb stump, in particular a lower leg stump, or for use in creating a prosthetic socket or a part of a prosthetic socket, the set comprising a medical device (hereinafter: device for short).

[0008] The device can be used, for example, as a basis for creating lower limb prosthetic sockets (but also other prosthetic limbs, such as arm prostheses, thigh prostheses, etc.), preferably with the patient exclusively in a standing position.

[0009] Here, the device comprises a fluid or pressure vessel with exactly one or at least one fluid chamber, which may receive or store a fluid, optionally under pressure, where the pressure is higher than atmospheric pressure, the fluid being a gas or a liquid, preferably air or water, since these are cheap and readily available.

[0010] The pressure vessel comprises a wall made of or including at least one or exactly one first material.

[0011] The walls of the pressure vessel define its interior. According to the present invention, the interior of the pressure vessel is understood to be the space or volume defined by the geometric shape of the pressure vessel or the space or volume enclosed or surrounded by the outer wall of the pressure vessel. For example, if the pressure vessel is cylindrical, the interior space of the pressure vessel is bounded by the cylindrical side and the two end sides or faces. As another example, if the pressure vessel is rectangular, the interior space is defined by the result of multiplication of the height, width and depth of the rectangle. When determining the interior, it is irrelevant whether the space corresponding to the interior is liquid-tight or not. The interior does not represent a liquid-tight closed space, but rather a volume enclosed by the walls. Space that does not belong to the interior of the pressure vessel is referred to as the exterior in this specification.

[0012] The pressure vessel comprises an insertion port through which the limb stump (which in this respect may also be understood as the distal end of the stump rather than the entire stump) may be inserted into the interior of the pressure vessel. The insertion port may be, for example, an open end side or face, a through opening in a wall, or an opening that penetrates or interrupts a wall. In the region of the insertion port, the interior of the pressure vessel is thus not separated from the outside by a part of the wall. The insertion port may be in an entrance opening or an insertion face, through which the limb stump is inserted into the interior of the pressure vessel.

[0013] Furthermore, the pressure vessel comprises at least one or exactly one, preferably liquid-tight membrane, or alternatively, the pressure vessel does not comprise a membrane as further described below, but only a corresponding suitable and / or provided receiving device (such as a connector, described below as an option) for receiving the membrane in the pressure vessel.

[0014] The membrane is made of or includes a second material, the first and second materials being different from each other.

[0015] Optionally, at least one portion of the membrane in the upper and / or proximal region and / or facing the inlet of the pressure vessel is connected, preferably removably, to at least one connector. By using this at least one optional connector, the membrane is fixed, preferably removably, to the pressure vessel. The connector may be ribbon-like, rope-like, flexible and / or bendable.

[0016] The set according to the invention optionally further comprises at least one energy source for hardening or partially hardening the deformable material to take an impression of the residual limb or to create a prosthetic socket.

[0017] Furthermore, the set according to the invention optionally comprises a material that is initially deformable, for example deformable manually and without tools, but hardenable by an energy source. After hardening, this material is preferably no longer deformable, in particular not spalling, not permanent or residual and / or not deformable without tools, not flexible, flowable, elastic and / or bendable, etc. The material is preferably not gypsum (for example in the form of a gypsum bandage), does not contain gypsum, or preferably does not consist only of gypsum and / or a support material (fabric, mesh, gauze, etc.) that is required or usually used to hold wet gypsum.

[0018] The present invention optionally includes a set consisting of a medical device, an energy source, and a material.

[0019] A medical device may be provided for use in taking a negative impression of a limb stump, in particular a transtibial stump, where the device may comprise a fluid container (which may be a pressure container) for a liquid such as water, where the following may apply: The fluid container comprises an upper or first end side of the device in use and a lower or second end side of the device in use. In the region of the second end side, the fluid container may be closed in a liquid-tight manner, for example by a base region. The device comprises a film or membrane for receiving a part of the limb stump. The membrane is preferably connected to the container in a liquid-tight manner and / or closes the container or a part thereof at least partially at least at the upper or at least at the first end side in a liquid-tight manner. The fluid container may optionally comprise a pressure chamber. The fluid container optionally comprises at least one outlet for the fluid, which outlet optionally comprises a valve or a stopcock for opening and closing the outlet. The membrane is preferably bag-like (i.e. with a bag-like dead end as opposed to a tube with an open top and bottom). Optionally, at least the top and / or proximal part and / or the part located in the area facing the inlet of the pressure vessel is fixed, preferably detachably, directly or indirectly, to a part of the wall of the fluid vessel, e.g. at its base region or side or together with a part of the wall of the fluid vessel, e.g. by at least one connector. The membrane is preferably made of or comprises a material that is not elastic (or has only a small elasticity) or preferably not stretchable (or has only a small stretchability), at least in a first direction of the material, preferably in the longitudinal direction of the vessel or in the insertion direction of the limb stump. Instead of having the membrane and / or connectors described above, the device may be designed or configured to be connected to the membrane and / or connector. Suitable connecting devices for this purpose may be provided, for example, in the base region and / or in the side walls.

[0020] According to the invention, a method is proposed for adapting a deformable material, which is hardenable by an energy source, which may be a radiation source, to a patient's limb stump or for creating a prosthetic socket (or part thereof) for a patient's limb stump.

[0021] The method includes the step of providing a set according to the present invention.

[0022] Furthermore, if the pressure vessel of the medical device is not yet filled with a fluid, preferably a liquid, the method according to the invention comprises filling the fluid or pressure chamber of the pressure vessel with a fluid, in particular a liquid. Alternatively or additionally, it optionally comprises changing the liquid level in the fluid or pressure chamber such that the membrane is covered by liquid at least in its portion, over the entire circumference of said portion, or such that the membrane bulges outside the pressure vessel beyond the insertion opening of the pressure vessel. Still alternatively, providing a fluid or pressure chamber filled in this way or in any other suitable manner.

[0023] According to the invention, there is further proposed a prosthetic socket, or a part thereof, for example an outer socket or an inner socket, each made within a device of the set according to the invention or according to the method according to the invention, cured in whole or in part, or comprising or consisting of the material according to the invention.

[0024] According to the invention there is further proposed a membrane for use in the set according to the invention and / or in the method according to the invention, where the membrane is transparent and / or is provided with or connected to a radiation or light source.Furthermore, the use of the membrane as disclosed herein for the membrane is proposed.

[0025] According to the invention, a deformable material is proposed which is hardenable by an energy source.

[0026] According to the present invention, it is further proposed a liner as disclosed herein which is also an independent invention.

[0027] Furthermore, according to the present invention, a kit is proposed which consists of the material according to the present invention and a bag or other container such as a case, box, etc. in which the material according to the present invention is or can be stored, or which comprises both.

[0028] The inventive embodiments of each of the above subject matter may comprise one or more of the features described below in any combination, unless a particular combination is technically impossible for a person skilled in the art. The subject matter of the dependent claims each specifies an embodiment according to the invention.

[0029] In the foregoing and following descriptions, the use of expressions such as "may", "can have", "can" or "can have" should be understood as being synonymous with "preferably is" or "preferably has", respectively, and are intended to exemplify embodiments according to the present invention.

[0030] When numerical words are mentioned herein, those skilled in the art shall recognize or understand them as indicating a lower limit of the numerical value. Thus, unless this results in a clear contradiction to the skilled artisan, those skilled in the art shall understand, for example, "ein" or "einem" as including "at least one". This understanding is also encompassed by the present invention as an interpretation that a numerical word, for example, "one", may instead mean "exactly one" if this is clearly technically possible in the view of the skilled artisan. Both of these understandings are encompassed by the present invention and apply to all numerical words used herein.

[0031] Whenever spatial references such as "top", "bottom", "upper" or "lower" are mentioned in this specification, those skilled in the art will understand these, in case of doubt, as spatial information, to refer to the arrangement of the set according to the present invention with the equipment, in the orientation and / or intended use of the figures attached hereto.

[0032] Whenever embodiments are mentioned herein, they represent exemplary embodiments according to the present invention and should not be understood as limiting the present invention.

[0033] When the subject matter according to the present invention is disclosed herein as having one or more features in one embodiment, it is also disclosed herein that the subject matter according to the present invention, like the present invention, in other embodiments does not explicitly have this or those features, e.g., in the sense of disclaimers. Thus, for all embodiments mentioned herein, it applies that the opposite embodiment, for example, formulated as a negation, is also disclosed.

[0034] In certain embodiments, a pressure chamber is a sealed and / or sealable space in which fluid may be subjected to pressures above atmospheric pressure (abbreviated as atmosphere) and cannot escape from the space.

[0035] In some embodiments the membrane is arranged to form or alternatively delimit a pressure chamber, for example by being part of a wall of the pressure chamber or a boundary of the pressure chamber, being particularly elastic or having a portion that is elastic in only one direction (e.g. the circumferential direction).

[0036] The fluid chamber is referred to herein as a pressure chamber because it is capable of receiving and / or holding a fluid under pressure above atmospheric pressure.

[0037] In certain embodiments, the terms "fluid chamber" and "pressure chamber" are used interchangeably in certain embodiments and / or in embodiments where no one of ordinary skill in the art would disagree. Any reference herein to a "pressure chamber" may also apply to a "fluid chamber."

[0038] In some embodiments, the pressure chamber is located inside the pressure vessel, if the pressure prevailing in the pressure chamber does not exceed a certain pressure. Alternatively, in certain embodiments, the pressure chamber also extends outside the pressure vessel, if the pressure prevailing in the pressure chamber pressurizes the membrane so that it bulges outward, for example beyond the insertion opening, i.e. outside the pressure vessel. Thus, the pressure chamber may have a volume that varies depending on the pressure prevailing in the pressure chamber. The latter statement does not apply to a constant inner or internal volume of the pressure vessel.

[0039] In some embodiments, the fluid may be maintained within the pressure chamber at greater than atmospheric pressure even though the inlet extends through the wall.

[0040] In an embodiment, the pressure chamber serves as a receiver or support for the distal end of the patient's limb stump, which is inserted inside the pressure vessel. The fluid contained in the pressure chamber causes the membrane to adhere laterally or circumferentially to the distal end of the limb stump or the entire limb stump. In this way, the limb stump can be pressurized, if necessary, with a pressure that is preferably constant or the same, when viewed per unit area, over the entire membrane in the area of ​​the surrounding material layer, cast, etc. The latter can be an advantageous contribution of the invention, since a uniform pressurization can result in a uniform molding of the deformable, preferably hardenable, material, or wet cast. The contact of the membrane provided by the fluid stored in the pressure chamber can advantageously eliminate manual molding or significantly reduce the effort required for manual molding.

[0041] In some embodiments, the pressure chamber is a liquid-tight, enclosed space formed or defined, in whole or in part, by the walls and membrane of the pressure vessel. In some embodiments, the term "pressure chamber" may be substituted for the definition above.

[0042] In some embodiments, the pressure vessel is the vessel or space in which the pressure chamber is located.

[0043] In some embodiments, the pressure vessel is a water vessel.

[0044] In some embodiments, the term "pressure vessel" may be replaced with the terms "fluid vessel" or "water vessel."

[0045] In certain embodiments, the pressure vessel has a cylindrical shape.

[0046] In some embodiments, during intended use of the device, and with the inlet and outlet, if present, closed, the pressure chamber is designed and / or arranged such that the pressure prevailing therein depends in particular or exclusively on the insertion depth of the limb stump into the pressure vessel.

[0047] In a particular embodiment, the membrane, for example a second part of the membrane, in particular a part with increased strength compared to the other parts of the membrane (e.g. due to an increased wall thickness and / or other material properties, for example due to composite materials, coatings, etc.), is arranged in the region of the insertion port and is optionally connected to the wall directly or indirectly, in a detachable or non-detachable manner, preferably liquid-tight. The membrane preferably closes the insertion port like a cap, unless the pressure present in the pressure chamber deviates significantly from atmospheric pressure.

[0048] In some embodiments, the membrane is positioned to prevent fluid or mass exchange within the interior of the pressure vessel in the axial direction.

[0049] In certain embodiments, the membrane is always arranged in a single layer in the axial and / or radial directions, while in other embodiments, this is not the case.

[0050] In some embodiments, the membrane is directly or indirectly connected to the pressure vessel on a first end side of the pressure vessel, while it is not connected to a second end side opposite the first end side, but is connected using a connector disposed between the membrane and the end side, the connector preferably having a length of at least 5 cm.

[0051] In certain embodiments, the membrane is flat or balloon-like (ie, open at one end), but not tubular (ie, open at both ends).

[0052] In some embodiments, the membrane is permanently connected to the device. In certain embodiments according to the invention, permanent means that the membrane cannot be removed without the use of tools or can only be removed from the pressure vessel by breaking it, for example the membrane can be permanently but removably connected to the wall by one or more clamping rings (not to be confused with a connector in the sense of the invention, which may additionally be provided) and one or more screws. A removal function using a tool can be advantageously provided to allow replacement of the membrane, for example due to wear after several uses. However, in these embodiments the membrane is not intended to be removable from the pressure vessel by simply pulling it up, pulling it down, etc. At the same time, the permanent fixation can advantageously ensure that the forces transmitted to the membrane by the fluid during the use of the device in the pressure vessel cannot remove the membrane from the pressure vessel or its wall.

[0053] In some embodiments, the device is designed to take a negative impression of the limb stump. The wall thickness of the negative impression is preferably 2 mm to 8 mm, particularly preferably 3 mm to 6 mm. The negative impression may consist of or comprise a hardenable material, which is also encompassed by the method according to the invention.

[0054] In some embodiments, the method includes manufacturing or creating a prosthetic socket, a part thereof, or a complete prosthesis, i.e. a ready-to-use prosthesis, based on the hardened material, without previously making a positive mold of the limb.

[0055] In some embodiments, the method does not include making a plaster cast of the limb stump.

[0056] In certain embodiments, the prosthetic socket preferably has a wall thickness of from 2 mm to 12 mm, preferably from 3 mm to 8 mm, more preferably from 4 mm to 6 mm.

[0057] In some embodiments, at least one connector is secured to the base region, wall, and / or second end side of the pressure vessel, preferably by one end or terminal portion of the connector, while the other end or terminal portion is preferably connected to the membrane.

[0058] Using this fixation, the connector can secure the membrane to the inside of the pressure vessel and therefore prevent the membrane from bulging or protruding outwardly beyond the insertion opening, which is particularly advantageous in allowing the limb stump to be easily inserted into the interior of the pressure vessel.

[0059] The connector may be secured to the base region, wall, and / or second end side of the pressure vessel by mechanical fastening devices, such as hooks, clamp connections, screws, rivets, and the like.

[0060] In some embodiments, the length of at least one connector is at least 10 cm long, in other embodiments at least 20 cm long, and in still other embodiments at least 30 cm long.

[0061] In some embodiments, the at least one connector is not for connecting the membrane at an upper end region of the wall of the pressure vessel and / or for providing a liquid tight connection between the membrane and the pressure vessel.

[0062] In some embodiments, the at least one connector is connected to a reinforced portion of the membrane, which may comprise, for example, an increased wall thickness, other materials, and / or a material coating.

[0063] The reinforced portion of the membrane may, for example, have greater strength. Increased forces, particularly frictional forces, exerted on the reinforced portion may be advantageously distributed through the connector by the reinforced portion of the membrane, for example, when the limb stump is inserted or withdrawn from the pressure vessel interior of the device.

[0064] Further parts of the membrane that are not exposed or affected by these forces, at least not completely, may have other material properties, for example to allow a more comfortable and softer fitting of the limb stump in the membrane within the pressure chamber during the taking of the impression. In particular, the distal region of the limb stump is often particularly sensitive to pressure and therefore should be relieved as much as possible during the taking of the impression.

[0065] In some embodiments, the reinforced portion of the membrane is connected on one side to at least one connector and on the other side to the wall or base of the pressure vessel.

[0066] In some embodiments, at least two connectors are fixed around the periphery of the membrane. Similarly, three, four, five, six or more connectors may be fixed around the periphery of the membrane. The connectors may be fixed around the periphery of the membrane at regular or irregular distances from each other.

[0067] In some embodiments, the pressure chamber of the pressure vessel contains or is filled with water or another liquid within it. Liquids are incompressible and therefore provide highly reproducible results when casting, making water the cheapest and most readily available option.

[0068] In certain embodiments, the walls of the pressure vessel are at least partially transparent, which may allow the prosthetist to visually monitor insertion depth and other aspects in a simple manner as he or she takes the impression. In addition, light, e.g., ultraviolet light, may be allowed to enter.

[0069] In some embodiments, the pressure vessel includes one or more markings in the area of ​​at least one transparent portion thereof, the insertion depth of the limb stump may be read on said markings.

[0070] In some embodiments, the pressure chamber is formed or defined by at least a part of the wall and the membrane. The membrane is connected to the wall part, preferably in the second end side region of the pressure vessel, by a material joint, a pressure-fit joint and / or a mold-fit joint. There may be a connector or a connection device provided for this purpose. Unwanted bulging, shifting, lifting or stretching of the membrane towards the top or outside of the pressure vessel, in contrast to the inside of the pressure vessel where the membrane is supported laterally by the wall and does not protrude, may be prevented or tolerably limited by the connector in some embodiments according to the invention. Thus, the connector at least substantially, optionally, holds the membrane inside the pressure vessel. This or the connector may prevent unwanted lifting of the limb stump. Lifting may have an unfavorable effect on the pressure prevailing in the pressure chamber and the pressure acting on the limb stump by the membrane, in that the membrane is no longer in contact with the stump with a uniform pressure in all parts surrounding the stump. In connection therewith, the absence of optimal pressure on the residual limb when taking the impression leads to the fact that the impression is not taken under the loads that occur later when walking with the manufactured prosthesis. Furthermore, the reduction or prevention of lifting can contribute to the protection of the membrane, which is protected from damage inside the pressure vessel through the wall. When a connector is provided according to the invention, advantageously no other restriction of the membrane lifting, for example by a ring that tightly engages with the thigh, is necessary. The simplification that is brought about is easily understood by the skilled person, since such rings would have to be provided in several sizes in order to be able to take impressions of several different thicknesses of residual limbs using the equipment. In addition to the simplification of the use of the device, it also means a saving in the material, cost, etc. of the rings.

[0071] In a particular embodiment, the membrane is connected to the pressure vessel in the region of the inlet or in the region of the first end side of the pressure vessel and is additionally connected to a second region or part of the pressure vessel different from said region. The second region may preferably be located inside the pressure vessel and / or in the pressure chamber. The membrane may preferably be connected to the second region by a connector. The membrane may preferably only be indirectly connected to the second region, in other words, optionally connected via a connector, i.e. the membrane itself preferably does not directly connect to the second region, i.e. preferably does not touch it.

[0072] In some embodiments, the second region is a base region or a peripheral portion of the second end surface or end side.

[0073] In some embodiments, the connector is inelastic and non-stretchable.

[0074] In some embodiments, the connector is length adjustable. Its length can be adjusted by a corresponding adjustment device, preferably adjustable from outside the pressure vessel. As a result, the distance between the distal end of the membrane and, for example, the base region, the lower end side or the lower end surface of the pressure vessel varies. Thus, the membrane can be adjustably positioned within the pressure vessel, which in turn can allow the device of the set according to the invention to be optimally adjusted to a particular limb stump, regardless of the length of said limb stump.

[0075] In some embodiments, the connector connects the membrane directly or indirectly to an end side of the pressure vessel opposite the end of the pressure vessel comprising the insertion port, i.e., in particular, to the lower end side, end surface, or base region.

[0076] In some embodiments, the connector does not connect the membrane to the end surface, end side, or intermediate or central region of the base region, thus allowing or facilitating relatively free positioning of the limb stump inserted into the membrane within the pressure vessel without the connector exerting pressure over or through the membrane to the distal portion of the limb stump.

[0077] In some embodiments the connection is to be understood as a mold fit joint and / or a pressure fit joint and / or a material joint.

[0078] In some embodiments, the connectors are positioned to maintain within a specified limit the distance between the portion of the membrane connected to the connector on the one hand and the base region, lower end side, or lower end surface portion also connected to the connector on the other hand, which distance may be constant, for example, for non-elastic connectors.

[0079] In some embodiments, the membrane is directly connected to the wall, where the connectors can be the result of a joining process, e.g., glued parts, rivets.

[0080] In some exemplary embodiments according to the present invention, the membrane is connected at its connection region to the base region, the bottom side, or the bottom end side, while in other embodiments the membrane or membrane material is not connected to the above.

[0081] In certain embodiments, the membrane is made of or comprises a material whose elasticity or stretchability in a first direction of the material is different from its elasticity or stretchability in a second direction different from the first direction, where the second direction may optionally be perpendicular to the first direction. In these or other embodiments, the particular elasticity or stretchability in the first and / or second direction, respectively, is achieved by fibers provided in the membrane, which are embedded in, for example, silicone, a silicone matrix, or other material, preferably a liquid-tight material. Such fibers may extend in the first and / or second direction of the membrane, may extend substantially in the first and / or second direction, and / or may act substantially in the first and / or second direction. In this or other embodiments of the invention, the different elasticity or stretchability may additionally or alternatively be achieved by other designs.

[0082] When the membrane is ready for use or is secured to the pressure vessel as intended, the first direction may be the direction of insertion of the limb stump or the longitudinal direction of the pressure vessel. The second direction may be at an angle to the first direction, for example a right angle.

[0083] The fibers that extend, run or act in a first direction are optionally inelastic or only slightly elastic. Optionally, they are less elastic than the optionally provided fibers that extend, run or act in a second direction. The fibers that extend, run or act in a second direction, if present, may have a higher elasticity or resilience than the fibers in the first direction, and their elasticity may optionally correspond to that of the fibers that extend in the first direction. The fibers that run in the first direction are optionally selected, as are the fibers that run in the second direction. The elasticity or resilience of the fibers may match or correlate with that of the membrane. The fibers may be made of or include nylon. The fibers may be made of a tensile resistant material, in particular a material that is more tensile resistant than the material that embeds the fibers. For example, a design that prevents or significantly limits longitudinal stretch (which may optionally be a first direction) while at the same time allowing the membrane to stretch circumferentially or radially to conform to the limb stump may advantageously prevent undesired lifting of the limb stump. In addition, the relationship between the pressure chamber depth and the insertion depth within the membrane may advantageously remain the same. Also, the multi-piece sealing ring or femoral sealing ring described above may optionally be omitted. Furthermore, it may be possible to create a prosthetic socket according to the invention for a range of limb stumps with different cross-sectional thicknesses using only one membrane. The membrane advantageously fits snugly enough for both thick and thin stumps to prevent the membrane from wrinkling as described herein. In some embodiments of the invention, the membrane's ability to stretch in the cross-sectional or circumferential direction, even if longitudinal stretch is prevented or limited, advantageously contributes to this.

[0084] In some embodiments, the membrane is partially, at least in a portion thereof, or completely or entirely, less than 2 mm thick, preferably less than 1.5 mm thick, particularly preferably less than 1 mm thick. In some embodiments, the membrane has this thickness over at least 90% of its length, preferably over at least 95% of its length (in the longitudinal direction during use). This thickness distorts at most negligibly the difference between the actual shape of the limb stump and the hardenable material.

[0085] In certain embodiments, the walls of the pressure vessel are made of plastic, such as plexiglass or polycarbonate, or include one or more of these materials.

[0086] In certain embodiments, the connector, membrane, and / or base region include at least one thread for directly or indirectly threading the membrane or a component connected thereto into the pressure vessel.

[0087] In certain embodiments, the membrane is made of or includes a material that comprises fibers embedded in or otherwise connected to a matrix in the first direction and / or in the second direction.

[0088] In certain embodiments, the matrix or the membrane optionally comprising the matrix is ​​made of or comprises silicone.

[0089] In certain embodiments, some or all of the fibers have a wavy, curved, or zigzag configuration.

[0090] In certain embodiments, the membrane is inelastic or non-elastic in the first direction and / or the second direction.

[0091] In certain embodiments, "non-stretchable" or "non-elastic" refers to a material having an elastic modulus of at least 700 N / mm 2or preferably 1000N / mm 2 More preferably, 2000 N / mm 2 It means to exceed.

[0092] In certain embodiments, "non-stretchable" or "inelastic" means that the stretchability of each component (connector, membrane, fiber, etc.) is 20% or less of its length before the component breaks or breaks, preferably 10% or less, more preferably 5% or less, and most preferably 2% or less.

[0093] In certain embodiments, the membrane, its fibers, and / or the connectors have a modulus similar to nylon.

[0094] In certain embodiments, in addition to the top and / or proximal portion of the membrane and / or the portion of the membrane in the area facing the pressure vessel inlet, the bottom and / or distal portion of the membrane and / or the portion in the area of ​​the membrane facing away from the pressure vessel inlet and / or the portion in the base region are directly or indirectly, preferably removably, connected to the wall of the fluid vessel or to a portion of the wall of the fluid vessel, e.g., to a base or side region thereof, by the use of at least one connector, referred to herein as a distal connector.

[0095] What is said in this specification with respect to the connector, particularly with respect to its material, length, elasticity, stretchability and other properties, particularly the material properties, applies equally to the connector referred to in this specification as the distal connector, unless a contradiction recognizable to a person skilled in the art arises.

[0096] The distal connector may be designed and / or provided in any embodiment of the present invention as disclosed in WO 2016 / 135320, the disclosure of which is hereby incorporated by reference in its entirety into the subject matter of this application.

[0097] In some embodiments, the connector and / or distal connection is located entirely inside the pressure vessel, without contacting the exterior of the pressure vessel.

[0098] In some embodiments, the pressure vessel and / or the line communicating therewith is equipped with a pressure gauge to determine or measure the pressure prevailing in the pressure chamber, which the prosthetist may then use as a guide, for example, for the pressure rise mentioned above.

[0099] In some embodiments, the membrane is inwardly and / or outwardly deformable, preferably elastically stretchable, while in other embodiments the membrane is elastic in one direction but not elastic or relatively or substantially less elastic, particularly in a direction perpendicular thereto.

[0100] The device of the set according to the invention or any of its components, in particular the membrane and the membrane according to the invention, may comprise one or more features in any combination as disclosed in WO 2016 / 135320, the disclosure content of which is hereby incorporated by reference in its entirety as part of the subject matter of the present application.

[0101] In some embodiments, the membrane is made of a liquid-tight, in particular water-tight, material. The membrane may be made of or may include silicone. The membrane may be made of or may include fiber-reinforced silicone. Instead of silicone, a copolymer or rubber may be provided.

[0102] In some embodiments of the set according to the invention, the at least one energy source is or comprises a radiation source, in particular a light source, preferably an ultraviolet radiation source.

[0103] In some embodiments, the at least one energy source comprises at least five, preferably at least six, eight or more sources of ultraviolet radiation.

[0104] In some embodiments, the ultraviolet radiation source emits light with a wavelength of 405 nm, preferably emits radiation with a wavelength of 395 nm to 415 nm, particularly preferably emits radiation with a wavelength of 400 nm to 410 nm, or emits such radiation only.

[0105] In some embodiments, at least one energy source for curing or partial curing is connected to a portion of the pressure vessel.

[0106] In some embodiments, at least one energy source for curing or partial curing is not connected to the medical device, and in particular is not connected to any part of the pressure vessel.

[0107] In some embodiments, the at least one energy source is located outside the pressure vessel or pressure chamber of the medical device.

[0108] In some embodiments, the pressure chamber of the medical device contains water as a fluid, in particular this may be distilled water, water obtained by reverse osmosis or water treated in different ways.

[0109] In some embodiments of the set according to the invention, the medical device or part thereof comprises at least one part, in particular in the region of the wall of the pressure vessel, through which radiation, in particular light radiation or ultraviolet radiation, can pass, for example in the form of one or more windows.

[0110] In some embodiments, the medical device, or at least a portion thereof, particularly the walls, are made of or include a translucent, UV-resistant acrylic glass, such as Plexiglas®.

[0111] In some embodiments, particularly in the set of embodiments according to the present invention, the material is or comprises a photocurable resin, preferably an acrylic resin.

[0112] In some embodiments, particularly in the set of embodiments, the material is or includes a photopolymer.

[0113] In some embodiments, particularly in the set of embodiments, the material includes an odorant, which can help to impart a pleasant odor, such as the freshness of lemon, to the prosthetic socket in use.

[0114] In some embodiments, particularly in the set of embodiments, the material includes a reactive additive, which in certain embodiments may contribute to the fact that after initiation by UV light, areas that are not directly exposed to UV light or that are less exposed also cure.

[0115] In some embodiments, particularly in the set of embodiments, the material is applied to and / or incorporated into a braid, a tube, a sock, or a stocking.

[0116] The present invention further includes braids, tubes, socks or stockings, or mesh structures (these terms are used interchangeably in some embodiments) having the material of the present invention applied thereon or therein and / or incorporated therein, particularly as described herein.

[0117] In some embodiments, particularly in the set of embodiments, the braid, tube, sock or stocking is elastic, at least laterally elastic, or circumferentially elastic, in order to allow a fit around the limb stumps of the various patients in the best possible way, i.e. preferably as wrinkle-free as possible. In this case, it may also be elastic in the longitudinal direction, although this is not the case in certain embodiments. In addition to or instead of any elasticity in the circumferential direction, the braid, tube, sock or stocking may be variable in its circumferential dimension, for example by the use of fibers or strips, as described herein.

[0118] In some embodiments, particularly in the set of embodiments, the braid, tube, sock and / or stocking is multi-layered, i.e. comprises different layers.

[0119] In some embodiments, particularly in set embodiments, the braid, tube, sock, and / or stocking comprises or consists of multiple layers, preferably at least 4 layers, preferably at least 5 or 6 layers, which in certain embodiments may also be referred to as a "sandwich structure."

[0120] In some embodiments, the braid, tube, sock, mesh structure, and / or stocking, for example, has a layer on its inner side or on the side facing it that is finer than some or all of the layers located radially further outward. In this way, the light from the radial direction may initially enter from the relatively outside to the inside through the radial tightness of the fabric. Thus, in some embodiments, the fineness of the mesh may increase towards the limb stump. In other embodiments, this may be exactly the other way around. The latter embodiments are particularly suitable for curing by emitting light from the radially inside to the radially outward.

[0121] In some embodiments, particularly in sets of embodiments, some of the layers include or consist of fiberglass.

[0122] Glass fibers may advantageously provide the necessary strength in the finished prosthetic socket, since they have a relatively low density, yet high flexural, tensile, and compressive strength, and high resistance to chemical and biological influences. Additionally, glass fibers are thermally insulating and water repellent.

[0123] In some embodiments, the set comprises a liner and / or the liner is used in a method according to the present invention, specifically as each disclosed herein.

[0124] In some embodiments, the liner may comprise or be connected to a radiation source, in particular a light source or light guide, provided and / or suitable for the curing of the material according to the invention. In these embodiments, the liner may also be called a "curing liner". In these embodiments, light is thus emitted radially from the inside outwards, i.e. from the liner towards the membrane during curing inside the membrane, where the curable material is located between the liner and the membrane.

[0125] In some embodiments, the liners are present in a set or kit or otherwise in several sizes, for example exactly or at least 3, 5, 10, or 20 different sizes. Preferably, this serves to ensure that a liner suitable for each patient's stump anatomy is available for patient care from the set or kit.

[0126] In some embodiments, light, especially ultraviolet light, may be guided by the glass fiber. In such embodiments, the glass fiber or fibers may themselves be the energy source. Alternatively or additionally, the glass fiber or fibers may act as energy lines, e.g. light guides. They may be connected to an energy source, e.g. a light source. They may themselves emit light. Any necessary or suitable connectors, connections, etc. for this purpose may be provided and / or may be encompassed by the present invention.

[0127] In some embodiments, the braid, tube, sock and / or stocking layer, or any liner layer, in particular the outer layer, which preferably faces away from the patient's stump during intended use, may consist of or contain energy conductive, e.g. light conductive, glass fibers. Light introduced into, conducted by or conducted along this layer, for example by light radiation, may facilitate the hardening of the material, in particular a resin, preferably an acrylic resin, or a photopolymer. Thus, an external light source or a light source irradiating the medical device or its pressure vessel from the outside may not be necessary.

[0128] To allow better emission of light, any sheath of glass fibres which may be present may optionally be provided, at least in part, with light-transmitting openings, windows and / or the like.

[0129] In some embodiments, the curing of materials, particularly resins, preferably acrylics, or photopolymers, may be accelerated by using light transmitted through or along or emitted from layers containing glass fibers within braids, liners, tubes, socks, and / or stockings.

[0130] The "sandwich construction" may advantageously promote a homogenous construction of the prosthetic socket and ensure improved wearing comfort for the wearer of the prosthetic socket.

[0131] Providing multiple layers that overlap each other radially contributes to the fact that the intersections of different layers, e.g. mesh intersections, do not tend to overlap each other, or, if the intersections do overlap each other, radial material build-up does not create avoidable pressure points that would impair future patient comfort or the production process.

[0132] In some embodiments, particularly in sets of embodiments, some of the layers include or consist of mesh or braided portions.

[0133] In some embodiments, particularly in the set of embodiments, one of the layers, particularly the innermost layer, is made of or comprises an elastic fabric. Preferably, this is a white or light-colored fabric to increase light yield. Preferably, in these embodiments, the layer facing the patient's limb stump is made of a very finely woven or porous material to achieve the advantage of making the inner surface of the socket as smooth as possible. This may contribute to the later requirement for a step-free interior needed to apply the vacuum.

[0134] In certain embodiments, the liner may be moistened, for example, by soaking in water.

[0135] In some embodiments of the set, the innermost layer is designed to have light reflective or specular properties on its exterior, for example by means of a specular film.

[0136] The specular film may, in particular, increase the luminosity of the ultraviolet lamp and improve the transmission of the optionally multiple deformable layers that are curable by the energy source, which may also contribute to shortening the cure time.

[0137] In some embodiments of the set according to the invention, the set comprises a liner, e.g. as disclosed herein, preferably designed such that its outer surface is light reflective or specular, e.g. by a specular film. The patient may wear the liner on the skin. The liner may be placed between the limb stump and the hardenable material.

[0138] In a particular embodiment of the set, the outermost layer or layers have a loose mesh structure, for example a Chinese finger trap structure, which is particularly suitable and intended to be translucent.

[0139] In some embodiments, the material, in particular before curing, is connected to a connection, in particular a screw connection, for a distal prosthetic component, or the material partially surrounds said connection or is embedded in the material.

[0140] In some embodiments of the set according to the invention, the membrane of the medical device is at least partially transparent to radiation from the energy source, in particular light, preferably ultraviolet light, e.g. translucent or transparent.

[0141] In a particular embodiment of the set according to the invention, the set comprises a control device configured to limit the energy source so that the temperature inside the braid, tube, sock or stocking does not exceed 40°C. Corresponding measurements can be made in advance and the process controlled accordingly. If a temperature sensor is provided, a corresponding control system can be provided. This advantageously ensures that the patient does not get too hot when fitting the prosthetic socket and therefore feels more comfortable. In addition, damage to the skin caused by heat can be prevented.

[0142] Additionally or alternatively, a temperature sensor may be used as part of the thermal monitoring system.

[0143] In some embodiments of the method of the present invention, the method includes the further step of inserting the limb stump into a bag opening or bulge formed by the membrane inside the pressure vessel such that the limb stump is at least partially surrounded by the membrane around its entire circumference and such that a deformable material, which is hardenable by an energy source, is at least partially between the limb stump and the membrane.

[0144] In some embodiments of the method, the material may contact the membrane and / or the skin of the limb stump. Alternatively, the material may be separated from one and / or the other of the two by a separating layer, for example a separating layer made of a film. Similarly, the liner described above may be provided as a separating layer.

[0145] The liners disclosed herein may perform a cooling function. To this end, the liners may include connections for a cooling medium, such as a cooling element, a cooling fluid, the cooling medium may flow through the liner, etc.

[0146] In some embodiments of the methods of the present invention, the limb stump may already be surrounded or enveloped by the material prior to being introduced into the pressure vessel, or the limb stump may first be in direct or indirect contact with the material within the pressure vessel.

[0147] In some embodiments of the method of the present invention, the method includes the further step of removing the limb stump surrounded by material along with the material, followed by hardening or further hardening the material using an energy source outside of the pressure vessel.

[0148] In some embodiments, the method of the present invention includes the further step of removing the limb stump surrounded by the material together with the material after hardening the material using an energy source inside the pressure vessel.

[0149] In certain embodiments, the resin used reacts and cures only when exposed to UV light.

[0150] In some embodiments, the set according to the invention additionally comprises resin-impregnated fabric stockings, in particular in various sizes, pre-manufactured and / or pre-packaged under vacuum, in light-tight bags.

[0151] Advantageously, when the material is cured within the device, for example a resin irradiated by an ultraviolet light source, can cure without emitting a strong odor and / or heat.

[0152] In some embodiments, the resins used are provided in different colors.

[0153] In some embodiments, for example, a prosthetic socket cured by UV light may be used immediately as it is, without further manual processing, optionally at least as far as such a prosthetic socket is concerned. This may not affect the attachment of components necessary to obtain a ready-to-use prosthesis from the prosthetic socket. Such components may concern screws, valves, etc.

[0154] In some embodiments, the hardened prosthetic socket is subjected to further treatment, for example by ultraviolet light, in particular by thermal deformation.

[0155] In some embodiments, for example, a UV-cured material is provided with a direct distal threaded connection to other prosthetic components, while in other embodiments it is not.

[0156] In some embodiments, the membrane comprises a radiation conductive layer, an energy conductive layer, and / or a light conductive layer or portion.

[0157] In some embodiments, the membrane comprises a radiation-emitting layer, an energy-emitting layer, and / or a light-emitting layer, or a radiation-emitting portion, an energy-emitting portion, and / or a light-emitting portion, or a layer or portion that can be triggered to emit. Thus, the membrane may be provided with at least one light source or ultraviolet light source or other emitting device incorporated within itself or in the material forming it (e.g., as disclosed herein), for example between two of its layers, that can be triggered to emit light, radiation, etc. by being activated when required. For example, the provision of an ultraviolet light emitter available as a light source within the membrane and that can be made to emit light when required, but that preferably does not otherwise emit light, is encompassed.

[0158] In some embodiments, the device comprises a voltage source or a connection to a voltage source for supplying a voltage to the energy source or energy radiation source. In some embodiments, the voltage source is limited to a maximum output voltage of 12 V. The voltage source may be used, for example, as a voltage source for a radiation unit or a light source.

[0159] In some embodiments, the device comprises a mounting for at least temporarily fixing the radiation source to a part of the device, for example to a wall thereof.

[0160] In some embodiments, the radiation source is an induced current source.

[0161] In some embodiments, the light source or radiation source comprises or is in contact with a heat accumulator, for example made of aluminum, which can help prevent overheating of the radiation sources and thus extend their service life.

[0162] In some embodiments, the set or kit according to the invention comprises one or more mold bodies or mechanical mold bodies, such as blocks or staples, such as supracondylar staples, in addition to or instead of the energy source and / or the hardening material. These mold bodies can be made of, for example, carbon, plastic, fiber-reinforced plastic, in particular carbon fiber-reinforced plastic, or silicone, or can be made of containing materials. They can be provided and / or adapted to the patient's skin by direct application, or can be positioned and / or fixed, for example, by the use of a film. They can reduce the medial-lateral distance, for example, by applying pressure. The mold bodies serve to shape the prosthetic socket, for example by softening the patient's flexor tendons, so as to improve the wearing comfort of the completed prosthesis for the patient.

[0163] The mould body may be designed such that it can change shape or adapt to the patient, for example by heat, and such thermal adaptation may be part of the method according to the invention.

[0164] In some embodiments, the set comprises a computing device, which may be part of the medical device or may be connected to the medical device by physical or signal communication, although the computing device may also be provided separately from the medical device.

[0165] A computing device may be a control device and may include input devices (e.g., keyboard, scanner, mouse, interface, stick, memory unit, interface (e.g., Bluetooth), etc.) and output devices (e.g., monitor, display, printer, memory unit, interface (e.g., Bluetooth), etc.) and / or data memory.

[0166] The computing device is optionally configured to monitor and / or limit technical parameters, such as the (minimum) utilization rate of the radiation source or light source, its total operating time (e.g. distributed over a predefined time interval), the maximum utilization rate, the power of the radiation source, a predefined temperature at the light source and / or the patient, the number of operating cycles, etc., for example based on data stored in the data memory or based on input data that can be entered via the input device.

[0167] All characteristics and properties described for the materials of the set apply without limitation to the materials according to the invention, and vice versa.

[0168] In some embodiments of the kit of the present invention, the bag is a light and air tight bag.

[0169] In some embodiments, the kit comprises a plurality of braids, tubes, socks, or stockings as described herein, which may be present in one or more bags.

[0170] In some embodiments of the kit, at least two or more braids, tubes, socks, or stockings differ from each other in at least one corresponding area, e.g., differ from each other at the same height, the same distance from the distal end, etc.

[0171] In some embodiments of the kit, at least two or more of the braids, tubes, socks, or stockings have the same length (in the distal-proximal direction).

[0172] Some or all of the embodiments of the present invention may have one or more of the above-mentioned or following advantages.

[0173] The present invention has the advantage that for the first time it is possible not only to take a cast of a patient's limb stump, with the patient in a standing position and with the stump under load, but also to simultaneously produce a prosthetic socket reliably and, above all, reproducibly.

[0174] The invention thus makes it possible to take a mold as the basis for a socket that will conveniently fit the patient, especially when walking and standing. In this respect, less craftsmanship skills are required than previously required. The steps that were still necessary after obtaining a conventional plaster cast to obtain a prosthetic socket can be omitted.

[0175] The invention may therefore make it possible to produce sockets for human upper and especially lower limb prostheses in an objective manner, thus enabling the production of well-fitting prosthetic sockets, whereby the purely subjective, manual and costly work required by the prior art methods can be avoided.

[0176] Compared to the prior art, the present invention allows for the production of sockets for prosthetic limbs in an objective manner, which ensures better care or caring through improved fitting and may reduce production costs due to the absence or almost complete elimination of the need for costly manual post-processing and adjustments. In addition, time-consuming adjustment steps may also be significantly reduced, at least in number, or even completely eliminated, speeding up patient care.

[0177] A further advantage of the present invention may be that when using a hardenable material, such as a resin-impregnated stocking, the hardened socket can be used immediately as a prosthetic socket. Time-consuming mold-taking and casting, which requires high manual skills, may be advantageously omitted. This helps to save time and costs in terms of materials and labor.

[0178] A further advantage of the present invention may be that by proper selection of the amount or ratio of laminates or braids and resins, it is possible to ensure air tightness of the prosthesis socket, which may ensure that the prosthesis fits well on the patient's limb stump without the need for additional equipment, which may help save time and cost and improve the comfort of wearing the prosthesis for the patient.

[0179] Deformable materials that are curable by an energy source, such as resin-impregnated stockings, are preferably below 40°C during curing, which advantageously ensures that they do not become too hot for the patient and that the fitting of the prosthetic socket is perceived by the patient as comfortable.

[0180] Complete curing of the prosthetic socket can be achieved quickly, for example with ultraviolet light of a wavelength of 405 nm, in particular within 5 minutes and without any problems, which can also advantageously contribute to the patient's comfort when fitting the prosthetic socket.

[0181] A further advantage may be that manufacturing prosthetic sockets using the present invention may significantly avoid waste and save electricity and labor time compared to other prior art manufacturing methods. For example, the inventors have achieved 85% waste, 92.5% electricity, and 80% labor time savings in producing prototypes compared to conventional procedures.

[0182] A further advantage may be that prosthetic sockets made according to the present invention remain thermoplastically deformable even after curing, allowing, for example, a prosthetist to make minor adjustments to a patient's limb stump after fabrication.

[0183] The invention is described, by way of example only, with reference to the accompanying drawings, in which identical reference numbers indicate identical or similar elements, some of which are highly simplified, but the following applies: [Brief description of the drawings]

[0184] [Figure 1] FIG. 1 is a diagram showing a medical device set according to the present invention in a first embodiment, cut longitudinally from the side. [Figure 2a] 2A-2C are views of the device of FIG. 1 in further cross-section, in accordance with various embodiments; [Figure 2b] 2A-2C are views of the device of FIG. 1 in further cross-section, in accordance with various embodiments; [Diagram 3]4 shows a further embodiment of a device according to the invention in a longitudinal section and from the side; FIG. [Figure 4] 4 shows a further embodiment of a medical device of the set according to the invention in a longitudinal section and from the side; FIG. [Diagram 5] FIG. 5a is a schematic diagram of a braid into which material may be incorporated or applied, in one embodiment;FIG. 5b is a schematic diagram of the braid of FIG. 5a, shown from the side; [Figure 6a] FIG. 2 shows a schematic diagram of a possible braiding principle in yet a further embodiment. [Figure 6b] FIG. 2 shows a schematic diagram of a possible braiding principle in yet a further embodiment. [Figure 7a] FIG. 13 shows a braid in a further embodiment. [Figure 7b] 7b shows a braid with one or more mesh or braid layers, similar to the representation in FIG. 7a. [Figure 7c] 7b shows a braid with one or more mesh or braid layers, similar to the representation in FIG. 7a. [Figure 8a] FIG. 2 is a diagram showing a schematic simplified formwork body in the first embodiment. [Figure 8b] FIG. 8b is a schematic, simplified, top-down cross-sectional view of a limb stump with a mold body according to FIG. 8a; [Figure 8c] FIG. 13 shows a schematic simplified formwork body in a further embodiment. [Figure 8d] FIG. 8c is a top view of the schematic simplified formwork body. [Figure 9] FIG. 1 shows a schematic simplified exemplary path of a method according to the present invention for conforming a deformable material, which in one embodiment is hardenable by an energy source, to a limb or for creating a prosthetic socket or part thereof for a patient's limb stump. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0185] 1 shows a set of instruments 100 in a first embodiment according to the invention, said instruments 100 being cut lengthwise or longitudinally (i.e., from top to bottom with respect to FIG. 1). "Distal" means a downward position or direction. "Proximal" correspondingly is at or toward the top, higher position.

[0186] The first embodiment shows a pressure vessel 1 with a pressure chamber DK, a wall 3 and a membrane 5. The membrane 5 has a first or proximal membrane portion 5a that connects to an upper end 7 of the wall 3. In this exemplary embodiment, the first membrane portion 5a is optionally reinforced, as indicated by a thicker wall thickness (shown in FIG. 1 with thicker line thickness). The reinforcement design may alternatively or additionally be implemented by selection of different materials, fiber reinforced composites, material coatings, or other means.

[0187] Furthermore, the membrane 5 comprises a second or distal membrane portion 5b, which is arranged in a central portion of the membrane 5 and is connected to or integral with the first membrane portion 5a. Unlike the first membrane portion 5a, the second membrane portion 5b is optionally not reinforced, which is indicated by a thinner wall thickness (schematically depicted in FIG. 1 by a thinner line thickness).

[0188] The two different membrane parts 5a, 5b serve different loading situations of the membrane 5. When inserting and removing the limb stump KS into the membrane 5 and thus into the pressure vessel 1, the first membrane part 5a is loaded in particular by frictional forces between the limb stump KS and the membrane 5. Due to this increased loading, the first membrane part 5a is optionally reinforced. The second membrane part 5b has a sealing and holding function for the limb stump KS in the pressure vessel DK in particular at lower loadings compared to the first membrane part 5a.

[0189] Two optional connectors 53, the function of which will be described in more detail below, are in this exemplary embodiment optionally located at the connection site or interface between the first and second membrane portions 5a, 5b, or at the boundary region between the two. In particular, connector 53 is connected to first membrane portion 5a (optionally and alternatively at a location other than that shown in FIG. 1).

[0190] The connection between the connector 53 and the membrane portion 5a or 5b is designated with the letter A. In the embodiment of Figure 1, the connection A is optionally a distance B below the height H and / or the upper end of the wall 3.

[0191] Distance B may optionally be between 0 cm and 40 cm, preferably between 5 cm and 30 cm, particularly preferably between 8 cm and 10 cm.

[0192] The area of ​​connection A is shown enlarged on the left side of FIG.

[0193] The membrane 5 is preferably removably secured to the base region 4a, or alternatively secured to a region of the wall 3 (e.g., its upper, middle or lower regions), using at least two connectors 53 extending from a proximal portion of the membrane 5.

[0194] The proximal region of the membrane 5 is to be exemplarily understood here as the upper third of the membrane 5 or a region in the upper third of the membrane 5 .

[0195] It can be seen that the proximal region of the membrane 5 faces or is adjacent to the insertion port 9 .

[0196] It can be clearly seen that the area where the membrane 5 is optionally connected to the connector 53 is not located in the central, distal part 58 of the membrane. This advantageously prevents radial pressure on the membrane 5 in the distal part, due to the connector preventing the limb stump KS from lifting. This pressure can cause radial compression of the limb stump KS housed in the membrane 5, which can lead to an undesirable shape of the prosthetic socket molded and made from the hardening material, especially in the distal stump part. Providing the connector 53 in the proximal part can help to avoid such deformation of the distal part of the limb stump and can be advantageous for a correct shape in the mold. The connector 53 certainly causes radial pressure in the proximal part of the limb stump KS due to its proximal connection to the membrane. However, there (i.e. proximally or "top" with respect to FIG. 1), the limb stump KS has a stronger anatomical structure and is less susceptible to radial compression that can be avoided by the present invention in some embodiments.

[0197] The pressure vessel 1 is optionally purely cylindrical as shown in Fig. 1 and optionally comprises a first end side 2 (at the top of Fig. 1) and a second end side 4 (at the bottom of Fig. 1). In the exemplary embodiment of Fig. 1, the second end side 4 is liquid-tight to the exterior Ae by means of a bottom plate or base area 4a. The base area 4a may be made of the same material as the wall 3. The base area 4a may be manufactured integrally with the wall 3.

[0198] The membrane 5 separates, in a liquid-tight manner, the fluid chamber or pressure chamber DK of the pressure vessel 1 from the outside of the fluid chamber or pressure chamber DK, or, for example, from the outside Ae, i.e., the environment of the pressure vessel 1, or, as shown in FIG. 1, from the limb stump KS inserted into or surrounded by the membrane 5.

[0199] The membrane 5 may be connected in a liquid-tight manner to the pressure vessel 1 at a periphery 7, often of round, rectangular, square or different shape, at the top of the wall 3, or at another location.

[0200] The upper end 7 exemplarily lies in a plane in which an inlet 9 of the pressure vessel 1 lies or which delimits said inlet 9 at its periphery. The inlet 9 optionally lies in a plane H, which is represented by a dashed line.

[0201] The insertion port 9 serves to insert the limb stump KS surrounded by a hardening material into the interior I of the pressure vessel 1 .

[0202] The interior I is the volume of the pressure vessel 1 bounded by the wall 3. It extends from the second end side 4, made liquid-tight by the base region 4a, to an inlet designated 9 and outlined by a dashed line.

[0203] The pressure chamber DK is filled with a fluid, here exemplarily filled with liquid F depicted by a dot.

[0204] In Fig. 1 the device 100 is illustrated in a state in which a very roughly outlined limb stump KS of a standing patient is inserted into the interior I so that it is surrounded at least in its distal part by the membrane 5. The membrane 5 contacts the hardenable material (which is on top of the limb stump KS) like a second skin, where a further layer, such as a liner, may be provided between the hardenable material and the membrane 5.

[0205] The limb stump KS is loaded by the entire weight of the standing patient in the embodiment of Fig. 1. The amount of liquid F is adjusted, relative to the known volume of the interior I or pressure vessel 1, so that the limb stump KS can enter through the insertion opening 9 into the interior of the pressure vessel 1 at least as deep or far as is relevant for the creation of the prosthetic socket, so that at least the entire area where the hardenable material is present is in contact with the membrane 5. At the same time, the amount of liquid F is measured so that the distal end of the limb stump KS (at the bottom in Fig. 1) does not contact the bottom of the pressure vessel 1 or support itself there. In this way, it is ensured that the inserted limb supports the patient by the pressure of the fluid and that the hardenable material is subjected to the same pressure at all points by the membrane 5.

[0206] As shown in Figure 1, when no limb stump KS is inserted into the pressure vessel 1, the membrane 5 will be lifted or floated by the pressure of the fluid, here liquid, revealing a liquid level, which is not shown in Figure 1. The shape of the membrane 5 shown in Figure 1 therefore represents the shape that the membrane 5 will take under load when it fits closely to the inserted limb stump KS and is elastically stretched by the limb stump KS, in the embodiment of Figure 1, pressed deep into the medial side I, towards the base region 4a.

[0207] Further, from FIG. 1, both the wall 3 and the membrane 5 prevent fluid exchange between the pressure chamber DK and the outside Ae or fluid leakage from the pressure chamber DK, so that they allow a desired pressure to build up within the pressure chamber DK of the pressure vessel 1 but do not allow pressure to escape or dissipate from the pressure vessel.

[0208] As can be seen in FIG. 1, the pressure chamber DK is therefore optionally formed by the membrane 5 and at least a portion of the wall 3, where the portion of the wall 3 also includes a base region 4a of the end side 4.

[0209] 1 further illustrates an optional outlet 19' in the side wall or wall 3 of the pressure vessel 1. If an outlet 19' is provided, the outlet 19' may be provided elsewhere in the pressure vessel 1, for example in the base region.

[0210] The outlet 19' connects the interior I in the region of the pressure chamber DK to the exterior Ae of the pressure vessel 1. It makes it possible to specifically change the filling level and / or the pressure in the pressure chamber DK, for example by draining or filling the pressure chamber DK with fluid via the outlet 19'. For this purpose, the outlet 19' is provided with a valve or stopcock, not shown, which can be closed fluid-tight. The outlet 19', despite being designated as an outlet, can also be used to introduce a fluid and thus fill the pressure chamber DK.

[0211] 1, the membrane 5 is optionally and purely exemplarily connected to the base region 4a by a connector 53 or connectors 53. The connectors 53 optionally have no elasticity or stretchability (or only little elasticity or stretchability). The membrane 5 also optionally has no elasticity or stretchability (or only little elasticity or stretchability) in the longitudinal direction.

[0212] The connector 53 optionally allows the membrane 5 to float slightly and / or to a certain extent proximally (upwards in FIG. 1), or prevents it completely. Thus, a floating portion 81 that is more or less annular but closed around its periphery arises at the second end side 2. The floating portion 81 should be seen as a protrusion on the left and right of the limb stump KS according to the cross-sectional view in FIG. 1. The connector 53 may be provided to prevent such a floating portion 81.

[0213] The membrane 5 is in intimate contact with the limb stump KS (or an overlying stiffening material, liner, etc.) at a contact surface 83, which is more or less annular but closed at its periphery. The contact surface 83 is a circumferentially closed line or surface that includes the point where the limb stump KS has final or proximal closing contact with the membrane 5. The contact surface may also be referred to as a contact area or contact line.

[0214] At the same time, the membrane 5 is optionally in contact with or fixed to a boundary portion 85, which is also closed around the radial periphery of the membrane 5 in the region of the second end side 2 of the wall 3. The boundary portion 85 can be understood as the region where the boundary of the pressure chamber DK transitions from the boundary by the wall 3 to the boundary by the membrane 5. This can be well understood in that in FIG. 1 , the pressure chamber DK below the tip of the arrow of the line marked with the symbol 85 is defined only by the wall 3, and above by only the membrane 5, which in turn cannot support itself against a part of the wall 3.

[0215] Fixation of the membrane 5 in the interface 85 can be achieved by various means. However, in this and any other embodiment, the membrane 5 is not fixed by the connector 53. Fixation of the membrane 5 by the connector 53 takes place in the region of the connection A.

[0216] The floating portion 81 can be adjusted by releasing or introducing fluid through the outlet or inlet 19' in interaction with the connector 53, so that the contact surface 83 and the boundary portion 85 are at the same height H (H being the height from the base region 4a) outlined by a dashed line in Figure 1. Based on the experience of the inventors of the present invention, when this happens, therefore optimal pressure conditions for taking the mold are provided.

[0217] Even if the length of the connector 53 is not adjustable, the connector 53 advantageously ensures that no floating portion 81 occurs within a predetermined range exceeding the height H. The predetermined range may be 1 to 4 cm, particularly preferably about 2 cm.

[0218] FIG. 1 shows an optional distal connector 91, which is not shown in FIG. 3 but may be provided in any embodiment.

[0219] Figure 2a shows the device 100 according to the invention of figure 1 in a further cross section BB. Cross section BB shows a cross section of the device 100 in a longitudinal position where the optional connectors 53 are connected to the membrane 5. The direction of view of cross section BB is downwards towards the base region 4a in figure 2a. In figure 2a, four connectors 53 are arranged, each offset by approximately 90 degrees in the circumferential direction. Alternatively, the connectors may be arranged irregularly along the periphery. The connectors 53 may also be arranged in any number and at any distance from each other (approximately every 5 cm along the periphery).

[0220] The connector 53 is fixed at one end to the membrane 5 and at the other end, preferably to the base region 4a. The limb stump KS is located in the center of the membrane 5.

[0221] The connectors 53 may be connected to one another, for example by all of the connectors 53 being radially positioned within an annular device or being connected to an annular device that is respectively guided around the periphery of the membrane 5.

[0222] Figure 2b shows the arrangement of Figure 2a, however with six connectors 53, each of which is circumferentially offset by approximately 60 degrees. Alternatively, the connectors may be arranged randomly or sparsely around the circumference.

[0223] 3 shows the device 100 according to the invention in a further embodiment, cut longitudinally and from the side. In this embodiment, the connector 53 is fixed to the wall 3 of the pressure vessel 1. Functionally, the connector 53 fixed to the wall 3 has the same function, namely preventing unwanted floating of the membrane 5. Fixing to the wall 3 may have advantages in terms of assembly and / or handling during use of the device 100 according to the invention.

[0224] FIG. 4 shows a further embodiment of a medical device 100 of the set according to the invention in a longitudinal section and from the side.

[0225] Reference is made to the description of the preceding figures.

[0226] As shown in FIG. 4, the membrane 5 is elastically filled deep within the interior I towards the base region 4a by the load exerted by the inserted patient's limb stump KS, and therefore contacts the base region 4a without accumulating any particular wrinkles or bulges.

[0227] 4, on the left and right sides, a light source or ultraviolet light source 95 is arranged in the pressure chamber DK as an example of an energy source or radiation source, here exemplarily arranged on the inner wall of the pressure chamber DK. Alternatively or additionally, the light source or ultraviolet light source 95 is arranged outside the pressure chamber DK and / or inside the pressure vessel 1, but not in the pressure chamber DK and / or in the liquid F. Alternatively, the light source or ultraviolet light source 95 is provided outside the pressure chamber DK and / or outside the pressure vessel 1 and is not connected to the medical device 100.

[0228] In the case of multiple UV light sources 95, the UV light sources 95, as an example of energy or radiation sources, may be evenly distributed around the periphery or at different distances from each other. For example, the UV light sources may be arranged over the entire length of the pressure chamber DK, i.e., in the vertical direction in FIG. 4, or only on a part of it, and / or over the entire periphery or only on a part of it.

[0229] In alternative or additional embodiments, the walls 3 of the pressure vessel 1 and the pressure chamber DK of the pressure vessel may have energy transparent and / or translucent portions similar to windows, and the ultraviolet light source 95 may be located outside the pressure vessel 1. This is also encompassed by the present invention.

[0230] The limb stump KS is covered or coated with a stocking S which is impregnated with resin or consists of or contains resin and / or another hardenable material to create a prosthetic socket, and then the stocking S together with the limb stump KS is inserted into the pressure chamber DK and into the membrane 5 through an opening in the pressure chamber DK.

[0231] An optional cup-shaped object, such as a vector tower 99, may be made, for example, of plastic, and may be inserted into the membrane 5 together with the limb stump KS, or may be provided within the pressure chamber DK and thus in the fluid, in either case to relieve the distal end of the limb stump KS from fluid pressure acting on its distal side.

[0232] When the object is present as part of a set or equipment, it may, for example, have a hole 99' or other radiotransparent portion, particularly a translucent portion such as a window, at least in the topmost segment or end of the object, through which light, particularly ultraviolet light from ultraviolet source 95, can reach the tip of the limb stump KS.

[0233] Light emission 97 from several UV sources 95 is indicated by wavy lines, which causes a complete or at least partial curing of a resin or other suitable material that has been impregnated into the stocking S or that has otherwise been placed around the limb stump KS. The stocking S, now cured, may then be used directly as a prosthetic socket or may be further processed into a material for a prosthetic socket, for example by thermoforming and / or attaching a screw connection to a further prosthetic part.

[0234] FIG. 5a shows a schematic diagram of a braid 110 according to the invention (optionally a "sandwich structure" of a tube, sock or stocking, hereinafter braid 110) into which, in one embodiment, a material or materials according to the invention, optionally materials of a set according to the invention, are inserted or applied.

[0235] A cross section through the braid 110 is shown, inside of which the limb stump KS is in a pressure chamber DK during fitting of the prosthesis, and outside of which a fluid F acts on the braid 110, separated by at least a membrane 5.

[0236] In the embodiment of Fig. 5a, the braid 110 is multi-layered, i.e., comprises different braided or fabric layers 111, 113, 115, 117, which for clarity are shown as circular layers (or stacks) of different diameters. This figure is purely illustrative and should not be understood as limiting. Other shapes / configurations of the braid are also encompassed by the present invention.

[0237] In some embodiments, two or more braided layers 111, 113, 115, 117 may have the same shape / configuration, the same size, and / or the same orientation.

[0238] In the embodiment of Figure 5a, the braid comprises four braided layers 111, 113, 115, 117 and a textile layer, which may be, for example, a liner 119. The number and arrangement of layers or braided layers is purely exemplary and should not be understood as limiting.

[0239] In some embodiments, one or more of the layers, for example braided layers 111, 113, 115, 117, include or consist of fiberglass.

[0240] Providing multiple layers that overlap each other in the radial direction R contributes to the fact that, if the individual braided layers 111, 113, 115, 117 have the form of, for example, a mesh, the intersection points within the individual braided layers do not tend to overlap each other throughout the braid 110, or, if the intersection points do overlap each other, radial material accumulation does not create avoidable pressure points that would impair future patient comfort or the production process.

[0241] In some embodiments, some of the layers include or consist of mesh or braided portions.

[0242] Preferably, the optional liner 119 forms the innermost layer and is preferably made of or comprises an elastic fabric. Preferably, the optional liner 119 is a white fabric to increase light yield. Preferably, in these embodiments, this liner 119 or this layer that ultimately faces the patient's limb stump KS is made of a very finely woven or porous material to advantageously achieve as smooth an inner surface of the prosthetic socket produced according to the invention as possible. This may contribute to achieving a rear, preferably step-free inner side of the prosthetic socket, which is necessary for applying the vacuum, and thus a good fit of the prosthetic socket to the limb stump KS.

[0243] In certain embodiments, the liner 119 may be wetted, for example, by soaking in water.

[0244] In the embodiment of Figure 5a, optional liner 119 optionally forms the innermost layer of braid 110. The outside is illustratively designed to be light reflective or specular, for example by means of a specular film 120 (see Figure 5b).

[0245] Figure 5b is a schematic side view of the braid 110 of Figure 5a, again shown in cross section, but with only one longitudinal segment shown over its entire length, rather than the entire braid 110. The entire braid 110 will extend further up and down, i.e., in the longitudinal direction L, than is shown in Figure 5b.

[0246] To avoid repetition, reference is made to the discussion regarding FIG. 5a.

[0247] Although not shown in Figure 5a, an optional specular film 120 is preferably seen between the outermost portions of the braided layers 111, 113, 115, 117 and the liner 119. The specular film 120 may, among other things, increase the luminosity of, for example, an ultraviolet lamp, improving its penetration into the optionally multiple, deformable braided layers 111, 113, 115, 117 that are curable by an energy source, which may also contribute to a shorter cure time for the material of the present invention.

[0248] In some embodiments, as shown in Figures 5a and 5b, the material according to the present invention that may be incorporated or applied to the braid 110 is or includes a photocurable resin, preferably an acrylic resin. It may be or include a photopolymer. It may include reactive additives and / or odorants.

[0249] 6a and 6b are schematic diagrams of possible principles for the braid 110 or individual layers thereof in yet another embodiment.

[0250] In this case, the braid 110 is represented by an elongated or elongated mesh or braided structure portion 210 (hereinafter, portion 210 for short), which is intended to embody or represent a fiber or thread or strip. The elongated portion 210 is connected at one or more, e.g., end portions and / or a central portion, herein referred to as crossover points or knots 220, to at least one other elongated portion 210, e.g., at least one adjacent elongated portion 210, in particular in a mold-fit and / or pressure-fit manner.

[0251] However, between such intersections or knots 220, the portions 210 connected thereto are preferably spaced apart from adjacent portions 210, as outlined by spaces Z in Figures 6a and 6b, ultimately resulting in a mesh structure with each individual space Z enclosed.

[0252] 6a and 6b, the intersections 220 are preferably knots between fibers and / or yarns, preferably represented by segments 210. The segments 210 may be connected to one, two or more other segments 210.

[0253] A comparison of Figures 6a and 6b shows the possibility of any scissor-like or diamond-like variation in the arrangement of portions 210 by intersections 220, where relative movement between two portions that contact each other at a particular intersection 220 is not required and therefore may or may not be permitted.

[0254] Arranging several layers of such braid 110 or braided layers 111, 113, 115, 117 radially overlapping each other contributes to the fact that the intersections 220 of these layers, for example of the mesh, are unlikely to overlap each other or only in few cases, or, if they do overlap each other, radial material accumulation does not create or gives no reason to create avoidable pressure points that would impair the wearing comfort for the patient of the prosthetic socket produced according to the invention or the process of creating said prosthetic socket.

[0255] FIG. 7a shows only a schematic and highly simplified cross-section of a braid 110 in a further embodiment.

[0256] The braid 110 is shown cut open, without the shape used in the device 100 or set according to the invention, which could be achieved by joining the left and right ends together and trimming or cutting as necessary, as shown exemplarily, or at least diagrammatically, in Figure 5a.

[0257] In Figure 7a, it is assumed that the braid 110 includes exactly one braided layer, such as those disclosed herein and shown, for example, in Figure 5a at 111, 113, 115, or 117. However, what is shown in Figure 7a may also apply or be generalized to braids 110 having two or more braided layers. For clarity only, exactly one braided layer is shown in Figure 7a.

[0258] Two pairs of longitudinal and transverse fibres or longitudinal or transverse strips are shown purely by way of example, designated 55a and 57a, and 55b and 57b, respectively, and are here by way of example only perpendicular to one another. What has been said above with respect to portion 210 and what has not been disclosed herein with respect to fibres or strips 55a or 57a and as 55b and 57b may also be applied to the latter, i.e. fibres or strips 55a or 57a and 55b or 57b.

[0259] The longitudinal fibers 55a are optionally stretched and therefore optionally cannot be stretched any further in the longitudinal direction Lae.

[0260] In contrast, the transverse fibers 57a, which should be considered in relation, may enable the braid 110 to extend in the transverse direction Q due to their looped or twisted or wavy path, or due to the material in the matrix of the braid 110, which may be, in addition to the fibers, for example, soaked with or imbibed with a material according to the invention. The longitudinal fibers 55a and the transverse fibers 57a thus differ from each other, for example functionally, in their ability to extend or unfold or stretch under a tensile load, and optionally they also differ with respect to the material from which they are made and / or with respect to their cross-sections.

[0261] With the two exemplary considered fibers 55b and 57b belonging to each other, the same or similar effects can be achieved in different ways: the longitudinal fibers 55b are thick and therefore cannot stretch, or can stretch less compared to the associated thin transverse fibers 57b.

[0262] It will be appreciated that braid 110 may include more fibers than those shown here, and that braid 110 may preferably include both pairs of longitudinal and weft fibers 55a and 57a, or longitudinal and weft fibers 55b and 57b, preferably but not necessarily both pairs of longitudinal or weft fibers as discussed herein.

[0263] 7b and 7c show a braid 110 with one or more braided layers having longitudinal fibers 55 and transverse fibers 57, similar to the representation in FIG. 7a, where the transverse fibers 57 connect the longitudinal fibers 55.

[0264] The longitudinal fibers 55 run straight and the transverse fibers 57 run between adjacent (or non-adjacent) longitudinal fibers 55 with both transverse and longitudinal extension.

[0265] Thus, the transverse fibers 57 run in a zigzag pattern, for example as shown in Figures 7b and 7c, which may take a single zigzag path as shown in Figure 7b, a double zigzag path as shown in Figure 7c, or multiple zigzag paths, not shown, or may take other looped or serpentine paths.

[0266] In this case, the transverse fibers 57 and the longitudinal fibers 55 may indeed have the same structure and / or the same thickness. It is their arrangement relative to the longitudinal direction that makes the braid 110 stretchable or extensible (or more stretchable or extensible) (in the transverse direction Q) or instretchable or non-stretchable (or more instretchable or non-stretchable) (in the longitudinal direction Lae).

[0267] If the longitudinal fibers 55 are not allowed to run along straight lines, as shown in Figures 7b and 7c, but are instead allowed to run in a more or less pronounced zigzag pattern around a straight line along the longitudinal direction Lae, then shrinkage of the longitudinal braid 110 can be advantageously achieved, if desired. The possible shrinkage can thereby be "set" or limited in advance by adjusting the dimensions and size of the zigzag pattern of the longitudinal fibers 55 and / or the transverse fibers 57. Shrinkage can be advantageous in that it can simply and effectively structurally counteract undesired elongation of the braid 110.

[0268] Figure 8a shows a schematic simplified formwork body 300 in a first embodiment which may be used in the method according to the invention, which may be a component of a set or kit according to the invention. Such a formwork body 300 is for example made of silicone or another suitable material.

[0269] In the embodiment of FIG. 8a, the mold body 300 is applied from behind the patient's limb stump KS and is optionally fixed, for example by a film.

[0270] The design can be used to widen a prosthetic socket that is made posteriorly or dorsally, for example at the upper edge of the sepal, to allow for subsequent relaxation of the flexor tendons of the patient wearing the prosthetic socket. The widened area is shown at 305 in FIG. 8a.

[0271] As shown in FIG. 8b, the arrow now points from posterior or dorsal to anterior or ventral.

[0272] FIG. 8b is a schematic, simplified cross-sectional view of a limb stump KS with the mounted or positioned formwork body 300 of FIG. 8a viewed from above.

[0273] 8c shows a schematic simplified knee joint of a patient proximally fitted with a mould body 301 herein in a further embodiment which may be a component of a set or kit according to the invention and which may be used in a method according to the invention. Such a mould body 301 may for example be made of or include plastic, reinforced or carbon reinforced plastic or other suitable material, in particular as disclosed herein.

[0274] In the embodiment of Fig. 8c, the mold body 300, optionally in the form of a brace, is applied from the anterior proximal side of the patient's knee joint. The mold body 301 serves to narrow the limb stump KS above the knee joint or compress the soft parts during the preparation of the prosthesis socket or plaster cast in order to improve the fit of the prosthesis manufactured on the basis of the limb stump KS compressed in this way to the patient, regardless of whether the prosthesis is manufactured from a hardenable material or conventionally, for example after a plaster cast. Such compression may be, for example, between 6 mm and 7 mm per side (lateral, medial).

[0275] FIG. 8d shows a schematic simplified top view of the formwork body 301 of FIG. 8c.

[0276] The form bodies 300, 301 may be placed from the anterior or ventral side of the limb stump KS, or from the posterior or dorsal side. The embodiments of Figures 8a to 8d are purely illustrative and should not be understood as limiting.

[0277] FIG. 9 shows a schematic simplified exemplary path of a method according to the present invention for adapting a deformable material, which can be hardened by an energy source, to a limb stump KS or for creating a prosthetic socket or part thereof for a patient's limb stump KS in a first embodiment.

[0278] Reference is made to the numerals relating to the previous figures.

[0279] Method step M1 represents providing a set according to the invention.

[0280] Filling the fluid chamber or pressure chamber DK of the pressure vessel 1 with a fluid as disclosed herein is represented by method step M2, or alternatively, this method step M2 represents providing a fluid chamber or pressure chamber DK thus filled.

[0281] Method step M3 shows the insertion of the limb stump KS into the membrane 5 such that the limb stump KS is at least partially surrounded around its entire periphery by the membrane 5 and a deformable material that is hardenable by an energy source is at least partially between the limb stump KS and the membrane 5. Alternatively, the limb stump KS may be at least partially surrounded or wrapped in a moist cast. Method step M3 may also optionally include placing the form body 300, 301 on the patient's skin.

[0282] Hardening or partial hardening of the material, optionally by using an energy source within the pressure vessel 1, is represented in method step M4.

[0283] Subsequently, the removal or removal of the limb stump KS, preferably together with the optionally fully or partially hardened material surrounding it, from the pressure vessel 1 is represented in method step M5.

[0284] Optional or further hardening or partial hardening of the material by using an energy source external to the pressure vessel 1 is represented in method step M6. This step may be performed in addition to or as an alternative to method step M4.

[0285] Optionally producing a complete prosthesis based on the hardened material and on the thus achieved prosthetic socket or each part thereof without prior taking a positive impression of the limb stump KS is represented in or based on method step M7.

[0286] Although the present specification focuses on the creation of prosthetic sockets based on hardenable materials, the invention is not limited thereto. Many combinations of features and embodiments are also in accordance with the invention, but they are based on traditional (negative model) plaster casts. For example, the use of a form body as described herein may thus be claimed as an invention. The use is not limited to the simultaneous use of hardenable materials. [Explanation of symbols]

[0287] 100 equipment 1. Pressure vessels 2 First End Side 3. Wall 4. A second end side, which may optionally be closed or sealed at the base region 4a Base region 5. Membrane 7 Upper end 5a Proximal or first membrane portion, reinforced portion of the membrane 5b Distal or second membrane portion 9 Insertion port 19' Exit, entrance 53 Connector 55 Longitudinal Fibers 55a Longitudinal Fibers 55b Longitudinal fibers 57 Transverse Fibers 57a Transverse fibers 57b Transverse fibers 58 Central or intermediate region or part of the membrane 81 Floating part of membrane 83 Contact point surface 85 Boundary part 91 Distal Connector 95 UV source 97 Ultraviolet Radiation 99 Vector Tower 99' hole, translucent part 110 Braids, tubes, socks, stockings 111 Braid layer, fabric layer 113 Braid layer, fabric layer 115 Braid layer, fabric layer 117 Braid layer, fabric layer 119 Liner 120 Mirror Film 210 Mesh structure part, braided structure part, part 220 Intersection, Knot 300 Formwork body 301 Formwork body 305 Extended area of ​​prosthetic socket A Connector Ae Outside the pressure vessel B distance DK Pressure vessel pressure chamber I. Inside the pressure vessel F Fluid or liquid H Pressure chamber height KS limb stump L Longitudinal Lae braid lengthwise Method steps from M1 to M7 Q Braid width R Radial direction

Claims

1. A set for use in taking a cast of a limb stump (KS), in particular a lower leg stump, or for use in creating a prosthetic socket or a part of a prosthetic socket, A medical device (100) comprising at least A pressure vessel (1) comprising a fluid or pressure chamber (DK) for receiving or storing a fluid (F), in particular a pressurized fluid, said pressure vessel (1) comprising a wall (3) made of a first material, said wall (3) defining an interior (I) of said pressure vessel (1) from an exterior (Ae), said pressure vessel (1) comprising an insertion opening (9) for inserting said limb stump (KS) into said interior (I) of said pressure vessel (1); a liquid-tight membrane (5) made of at least a second material, the membrane (5) being arranged to form or define the fluid chamber or the pressure chamber (DK); A medical device (100) comprising: At least one energy source for hardening or partially hardening the deformable material to obtain a mold of the limb stump (KS) or to obtain a prosthetic socket; and / or a deformable material that is hardenable by an energy source, the deformable material not being gypsum or consisting only of gypsum; A set comprising or consisting of:

2. The set according to claim 1 , wherein the at least one energy source is or comprises a radiation source, in particular a light source, preferably an ultraviolet radiation source (95).

3. 3. The set of claim 2, wherein the at least one energy source comprises at least five, preferably at least six, eight or more ultraviolet radiation sources (95).

4. 4. The set according to claim 2 or 3, wherein the ultraviolet radiation source (95) emits light with a wavelength of 405 nm, preferably emits radiation with a wavelength of 395 nm to 415 nm, particularly preferably emits radiation with a wavelength of 400 nm to 410 nm, or emits only such radiation.

5. 5. The set according to any one of claims 1 to 4, wherein the at least one energy source for curing or partial curing is connected to a part of the pressure vessel (1).

6. The set according to any one of claims 1 to 5, wherein the at least one energy source for curing or partial curing is not connected to the medical device (100), in particular not connected to any part of the pressure vessel (1).

7. The set according to any one of claims 1 to 6, wherein the at least one energy source is arranged outside the pressure chamber (DK), the pressure vessel (1) or the medical device (100).

8. The set according to any one of claims 1 to 7, wherein the pressure chamber (DK) of the medical device (100) contains water as fluid (F), in particular distilled water, water obtained by reverse osmosis or water treated in another way.

9. 9. The set according to any one of claims 1 to 8, wherein the medical device (100) or a part thereof, preferably a wall (3) thereof, in particular in the region of the wall (3) of the pressure vessel (1), comprises at least one portion through which radiation, in particular light radiation or ultraviolet radiation, is permeable.

10. 10. The set according to claim 9, wherein the part of the medical device (100), preferably the wall (3), comprises or consists of UV-resistant acrylic glass, for example Plexiglas®.

11. The set according to any one of claims 1 to 10, wherein the material is or comprises a photocurable resin, preferably an acrylic resin.

12. The set of claim 1 , wherein the material is or comprises a photopolymer.

13. The set of claim 1 , wherein the material comprises an odorant.

14. The set of any one of claims 1 to 13, wherein the material comprises a reactive additive.

15. 15. A set according to any one of claims 1 to 14, wherein the material is applied to and / or incorporated into a braid, mesh structure, tube, sock or stocking, respectively.

16. 16. The set of claim 15, wherein the braid, the tube, the sock, and / or the stocking are multi-layered.

17. 17. The set according to claim 15 or 16, wherein the braid, the mesh structure, the tube, the sock and / or the stocking comprises a plurality of layers, preferably at least 4 layers, preferably at least 5 or 6 layers.

18. 18. A set according to claim 16 or 17, wherein some of the layers comprise or consist of fibreglass and / or non-elastic fabrics or materials.

19. 19. The set of claim 16, 17 or 18, wherein some of the layers include or consist of mesh or braided portions.

20. 20. A set according to any one of claims 16 to 19, wherein one of the layers, in particular the innermost layer, is made of or comprises an elastic fabric or material.

21. 21. A set according to any one of claims 1 to 20, comprising a liner, preferably the outer surface of which is designed to be light reflective or specular, for example by means of a specular film.

22. 22. The set according to any one of claims 16 to 21, wherein the innermost layer is designed to have light reflecting or specular properties on its outer side, for example by means of a specular film.

23. 23. A set according to any one of claims 1 to 22, wherein the deformable material, before hardening, is connected to or partially surrounds or embeds a connection, in particular a screw connection, for a distal prosthetic part.

24. 24. A set according to any one of claims 1 to 23, comprising a liner having a light source or arranged to direct light therein.

25. The medical device (100) comprises: an outlet (19) which is a fluid passage between the fluid chamber or pressure chamber (DK) and the outside (Ae) of the pressure vessel (1); a valve, locking device, or stopcock for opening or closing the outlet (19) or the fluid passage; 25. The set according to any one of claims 1 to 24, comprising:

26. 26. The set according to any one of claims 1 to 25, wherein the membrane (5) of the medical device (100) is made of or comprises a material whose elasticity or stretchability in a first direction is different from its elasticity or stretchability in a second direction, optionally perpendicular to the first direction.

27. 27. The set according to any one of claims 1 to 26, wherein the membrane (5) of the medical device (100) is made of or comprises a material with fibres (55a, 57a; 55b, 57b) in a first direction and / or a second direction of the material, the fibres being preferably embedded in a matrix or preferably connected thereto by another means.

28. The set according to any one of claims 1 to 27, wherein the membrane (5) of the medical device (100) is inelastic or non-stretchable in a first direction and / or a second direction.

29. 29. The set according to any one of claims 1 to 28, wherein the membrane (5) of the medical device (100) is at least partially transparent to radiation from the energy source, in particular light, preferably ultraviolet light.

30. 30. The set of any one of claims 1 to 29, comprising a controller configured to limit the energy source, or its power or output, so that the temperature inside the braid, tube, sock or stocking does not exceed 40°C.

31. 1. A method of fitting a deformable material to a limb stump (KS), the deformable material being hardenable by an energy source, or a method of making a prosthetic socket or part thereof for a patient's limb stump (KS), comprising: Providing a set according to any one of claims 1 to 30; Filling the fluid chamber or the pressure chamber (DK) of the pressure vessel (1) with a fluid, in particular a liquid (F), or The liquid level in the fluid chamber or the pressure chamber (DK) is changed so that the membrane (5) is covered with the liquid (F) at least in that portion over the entire circumference of the portion, or the membrane (5) bulges beyond the insertion port (9) of the pressure vessel (1) to the outside (Ae) of the pressure vessel (1), or providing a fluid or pressure chamber (DK) filled in this way; The method includes:

32. The limb stump (KS), The limb stump (KS) is covered, surrounded or enveloped by the membrane (5) at least in its portion and over the entire circumference of the portion; and The deformable material, which is hardenable by an energy source, is at least partially between the limb stump (KS) and the membrane (5); 32. The method according to claim 31, further comprising the step of inserting the membrane (5).

33. 33. The method according to claim 32, wherein a formwork body (300, 301) is provided at least partially between the membrane (5) and the limb stump (KS).

34. removing the limb stump (KS) from the pressure vessel (1), preferably together with the material surrounding it; - curing or partially curing the material by using an energy source external to the pressure vessel (1); 34. The method of any one of claims 31 to 33, further comprising:

35. - curing or partially curing said material by using said energy source in said pressure vessel (1); removing the limb stump (KS) from the pressure vessel (1), preferably together with the fully or partially hardened material surrounding it; 35. The method of any one of claims 31 to 34, further comprising:

36. 36. The method of any one of claims 31 to 35, further comprising the step of introducing energy, e.g. light, into the liner or along the material of the liner.

37. 37. The method according to any one of claims 31 to 36, further comprising the step of producing a prosthetic socket, a part thereof or a complete prosthesis based on the hardened material without previously making a positive impression of the limb stump (KS).

38. 38. A prosthetic socket or part thereof made in the device of the set according to any one of claims 1 to 30 or according to the method according to any one of claims 31 to 37.

39. A membrane (5) or liner for use in a set according to any one of claims 1 to 30 and / or in a method according to any one of claims 31 to 37, wherein the membrane (5) or liner is transparent and / or comprises or is connected to a light guide and / or a light source (95).

40. A deformable material that is hardenable by an energy source.

41. 41. The material of claim 40, which is or comprises a photocurable resin, preferably an acrylic resin.

42. 42. The material of claim 40 or 41, which is or comprises a photopolymer.

43. 43. The material of any one of claims 40 to 42, comprising an odorant.

44. 44. The material of any one of claims 40 to 43, comprising a reactive additive.

45. 45. The material of any one of claims 40 to 44, applied to and / or incorporated into a braid, tube, sock, or stocking.

46. 46. ​​The material of claim 45, wherein the braid, the tube, the sock, and / or the stocking are multi-layered.

47. 47. The material according to claim 45 or 46, wherein the braid, the tube, the sock and / or the stocking comprises a plurality of layers, preferably at least 4 layers, preferably at least 5 or 6 layers.

48. 48. The material of claim 47, wherein some of the layers comprise or consist of fiberglass.

49. 49. The material of claim 48, wherein the glass fibre is connected or can be connected by connectors, connections or the like to an energy source, e.g. a light source, for conducting light, in particular ultraviolet light.

50. 50. The material according to claim 49, wherein the outer sheath of the glass fibres is at least partially provided with openings, windows or the like for allowing light, in particular UV light, to radiate from the fibres to promote hardening of the material.

51. 51. The material of any one of claims 46 to 50, wherein some of the layers comprise or consist of mesh or braided portions.

52. 52. The material according to any one of claims 46 to 51, wherein one of the layers, in particular the innermost layer, is made of or comprises an elastic fabric.

53. A material according to any one of claims 40 to 52; a bag in which said material may be or is stored; A kit consisting of:

54. 54. The kit of claim 53, wherein the bag is a light and air tight bag.

55. 55. The kit of claim 53 or 54, comprising a plurality of said braids, tubes, mesh structures, socks or stockings disposed within one or more bags.

56. 56. The kit of claim 55, wherein at least two or more of the braids, tubes, mesh structures, socks, or stockings differ from each other in at least one corresponding area, e.g., differing from each other at the same height, the same distance from a distal end, etc.

57. 57. The kit of claim 55 or 56, wherein at least two or more of the braids, tubes, socks or stockings are the same length in the distal-proximal direction.

Images