Kit having device for manufacturing prosthetic shaft from uv-curable resin material and method therefor

Abstract

The invention relates to a kit for impression of a limb stump (KS), in particular a shank stump, or for generating a prosthetic shaft or a part thereof. The kit comprises or consists of a medical device (100), at least one energy source and a deformable material curable by the energy source. The medical device (100) comprises at least one pressure vessel (1) having a fluid or pressure chamber (DK) for receiving or storing a fluid (F), the pressure vessel (1) comprising a fluid-tight membrane (5), the wall (3) of which is made of a first material and at least a second material, and an insertion opening (9) for inserting a limb stump (KS) into the interior (I) of the pressure vessel (1). The membrane (5) is configured to form or delimit a fluid or pressure chamber (DK). An energy source is used to cure or partially harden the deformable material in order to achieve an impression of a limb stump (KS) or to produce a prosthetic shaft.

Description

Technical Field

[0001] The invention relates to a set according to claim 1, to a method according to claim 31, to a prosthetic shaft or a part thereof according to claim 38, to a membrane according to claim 39, to a material according to claim 40 and to a kit according to claim 53, or to the preambles or general terms of these claims, respectively, and to the pad disclosed herein. Background Art

[0002] Leg amputees can regain mobility with leg prostheses. Modern leg prostheses consist of various modules, including the prosthetic shaft.

[0003] The invention relates to the technical field of manufacturing a prosthetic shaft for a prosthesis or manufacturing a prosthesis, preferably for a lower limb, ie for a leg prosthesis, in particular a lower leg prosthesis.

[0004] One object of the invention may be to propose a set with a medical device for taking an impression or creating a prosthetic shaft, or at least for its inner or outer shaft, in particular for a lower limb. Summary of the invention

[0005] The object according to the invention is achieved by a set having the features of claim 1. It is also achieved by a method having the features of claim 31, by a prosthesis shaft having the features of claim 38 and by a membrane having the features of claim 39. A material having the features of claim 40 and a set having the features of claim 53 can also be used to achieve the object according to the invention.

[0006] According to the invention, a kit for taking an impression of a limb stump, in particular a lower leg stump, or for producing a prosthetic shaft or a part thereof is therefore proposed. The kit comprises a medical device (hereinafter referred to as: device).

[0007] The device can be used as a basis, for example, to create a lower leg prosthesis axis (and other prostheses, such as arm prostheses, thigh prostheses), preferably on a patient who can stand.

[0008] Here, the device comprises a fluid container or pressure vessel with a precise or at least one fluid chamber. This can receive or store a fluid that can be pressurized. Here, the pressure is higher than atmospheric pressure. The fluid is a gas or a liquid, preferably air or water, because the latter two are both readily available.

[0009] The pressure vessel comprises a wall which is made of or comprises at least one first material.

[0010] The walls of the pressure vessel limit its interior. According to the present invention, the interior of the pressure vessel is understood to be a space or volume that is limited by the geometry of the pressure vessel or surrounded or enclosed by the outer wall of the pressure vessel. If the pressure vessel is, for example, cylindrical, the interior of the pressure vessel is a space defined by the cylindrical shell surface and two end sides or end planes. If the pressure vessel is rectangular in another example, the interior space is defined by the result of multiplying the height, width and depth of the rectangle. When determining the interior, it is not important whether the space corresponding to the interior is liquid-tight. The interior is not a closed space that does not leak fluid, but a volume surrounded by walls. The space that does not belong to the interior of the pressure vessel is referred to as its exterior in this article.

[0011] The pressure vessel comprises an insertion opening through which the limb stump can be inserted into the interior of the pressure vessel, in which respect the stump in the present context can also be understood to mean the distal end of the stump rather than the entire stump. The insertion opening can be, for example, an open end side or end plane, a through opening in a wall or an opening that breaks through or interrupts the wall. In the region of the insertion opening, the interior of the pressure vessel is therefore not separated from the exterior by a part of the wall. The insertion opening through which the limb stump is inserted into the interior of the pressure vessel can be located in the inlet opening or in the insertion plane.

[0012] Furthermore, the pressure vessel comprises at least one or exactly one, preferably fluid-tight membrane. Alternatively, the pressure vessel does not comprise such a membrane as further described below, but only comprises correspondingly suitable and / or provided receiving means (such as a connector described below as optional) for receiving the membrane on / at the pressure vessel.

[0013] The membrane is made of or comprises a second material.The first material and the second material are different from each other.

[0014] Optionally, at least one portion of the membrane located in the upper and / or proximal region and / or facing the insertion opening of the pressure vessel is preferably releasably connected to at least one connector. By using this at least one optionally connector, the membrane is fastened to the pressure vessel, preferably releasably fastened to the pressure vessel. The connector can be ribbon-like, rope-like, flexible and / or bendable.

[0015] The kit according to the invention may optionally also comprise at least one energy source for curing or partially curing the deformable material in order to obtain an impression of a limb stump or to form a prosthetic shaft.

[0016] In addition, the set according to the present invention may optionally include an initially deformable material, for example, manually and without the use of an instrument, which material can still be cured by an energy source. After curing, the material is preferably no longer deformable, particularly not free of debris, permanent or retained and / or non-deformable, flexible, fluid, elastic and / or bendable, etc., without the use of an instrument. The material is preferably not plaster (for example, in the form of a plaster bandage), does not contain plaster, or is preferably not composed of only plaster and / or the supporting material (fabric, net, gauze, etc.) that is required or is generally used for, to keep a moist plaster.

[0017] The present invention optionally encompasses a kit comprising a medical device, an energy source, and a material.

[0018] The medical device may be provided for obtaining a negative impression of a limb stump, in particular a lower leg stump, wherein the device may include a fluid container (which may be a pressure container) for a liquid (e.g. water), wherein the following may apply: when the device is in use, the fluid container includes an upper end side or a first end side, and when the device is in use, the fluid container includes a lower end side or a second end side. 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 diaphragm for accommodating a portion of the limb stump. The membrane is preferably connected to the container in a liquid-tight manner and / or closes the container or part thereof in an at least partially liquid-tight manner at least at the top or at least at the first end side. The fluid container may optionally include a pressure chamber. The fluid container optionally includes at least one outlet for a fluid, which outlet may optionally be provided with a valve or a stopcock for opening and closing the outlet. The membrane is preferably bag-shaped (i.e., having a dead end like a bag, rather than a tube open at the top and bottom). Optionally, at least the upper and / or proximal part and / or the part in the area facing the insertion opening of the pressure vessel is, for example, fastened to the fluid container or to a part of the wall of the fluid container, for example the bottom area or the side surface of the fluid container, by at least one connector, preferably in a releasable, direct or indirect manner. The membrane is preferably made of or comprises a material which is not (or only slightly) elastic or preferably not (or only slightly) stretchable at least in a first direction of the material, preferably in the longitudinal direction of the container or in the insertion direction of the limb stump. Instead of having the aforementioned membrane and / or connector, the device can be designed or constructed to be connected to the membrane and / or connector. Suitable connecting means for this purpose can be provided, for example, on the bottom area and / or the side wall.

[0019] According to the invention, a method is proposed for applying a deformable material curable by an energy source, which may be a radiation source, to a limb stump or for producing a prosthetic shaft (or a part thereof) for a limb stump of a patient.

[0020] The method comprises the step of providing a kit according to the invention.

[0021] Furthermore, if the pressure vessel of the medical device is not already filled with a fluid, preferably a liquid, the method according to the invention encompasses filling a fluid chamber or a pressure chamber of the pressure vessel with a fluid, in particular a liquid. Alternatively or additionally, the liquid level in the fluid chamber or pressure chamber is varied such that the membrane is covered with liquid at least in parts of its entire circumference around these parts, or such that parts of the membrane protruding beyond the insertion opening of the pressure vessel into the exterior of the pressure vessel are optionally surrounded. Further optionally, a fluid chamber or a pressure chamber filled in this way or suitably filled in another way is provided.

[0022] According to the present invention, a prosthetic shaft or a part thereof, such as an outer shaft or an inner shaft, is also proposed, which has been manufactured in the device of the set according to the present invention, or has been manufactured according to the method of the present invention, or has been fully or partially cured, or it contains the material according to the present invention or consists of the material according to the present invention.

[0023] According to the invention, a film for a kit according to the invention and / or for a method according to the invention is also proposed, wherein the film is transparent and / or comprises or is connected to a radiation source or light source. The invention also proposes the use of such a film disclosed herein for a film.

[0024] According to the invention, a material is proposed which can be deformed and solidified by an energy source.

[0025] According to the present invention, there is also proposed a pad as disclosed herein, which is also an independent invention.

[0026] Furthermore, according to the invention, a kit is proposed, which consists of or contains the material according to the invention, and a bag or other container (such as a box, a case, etc. or the like) in which the material according to the invention is stored or can be stored.

[0027] Unless a particular combination is technically obvious to a person skilled in the art that it is not possible, embodiments of the invention according to each of the above-mentioned subjects may have one or more of the features mentioned below in any combination. The subjects of the dependent claims each specify an embodiment according to the invention.

[0028] In all the above and following statements, the use of the expressions “may be” or “may have”, “can be” or “can have” etc. should be understood as being synonymous with “preferably is” or “preferably has” and are intended to illustrate embodiments according to the present invention.

[0029] Whenever a numerical word is mentioned herein, it should be recognized or understood by those skilled in the art as an indication of a numerical lower limit. Therefore, unless this leads to an obvious contradiction to those skilled in the art, those skilled in the art should understand, for example, "one" (or "an") as covering "at least one". This understanding is also encompassed by the present invention, because a numerical word, such as "one" (or "an"), can alternatively mean "exactly one", as long as this is technically obvious from the perspective of those skilled in the art. Both understandings are included in the present invention and apply to all numerical words used herein.

[0030] Whenever spatial references such as "top", "bottom", "upper" or "lower" are mentioned herein, the skilled person will, in case of doubt, understand these to refer to the orientation in the accompanying drawings and / or the configuration of the device according to the present invention and in its intended use.

[0031] Whenever an embodiment is mentioned herein, it represents an exemplary embodiment according to the present invention and should not be construed as limiting.

[0032] When it is disclosed herein that the subject matter according to the invention comprises one or more features in a certain embodiment, it is also disclosed herein that the subject matter according to the invention comprises one or more features in other embodiments, respectively, for example, in the sense of a disclaimer, the invention expressly does not comprise this or these features. Therefore, for each embodiment mentioned herein, the opposite embodiment applies, for example, expressed as a negative, and is also disclosed.

[0033] In certain embodiments, a pressure chamber is a locked and / or lockable space in which a fluid may be subjected to a pressure above atmospheric pressure (in short: atmosphere) without being able to escape from the space.

[0034] In some embodiments, the membrane is arranged to form the pressure chamber or alternatively delimit the pressure chamber, for example as part of a wall or limitation of the pressure chamber, in particular as an elastic part or as an elastic part only in one direction (eg circumferentially).

[0035] The fluid chamber is referred to herein as a pressure chamber because it can receive and / or hold a fluid at a pressure above atmospheric pressure.

[0036] The terms "fluid chamber" and "pressure chamber" are interchangeable in certain embodiments and / or in those embodiments where a person skilled in the art would not object. The description herein of a "pressure chamber" may also apply to a "fluid chamber".

[0037] In some embodiments, the pressure chamber is located inside the pressure vessel when the pressure existing in the pressure chamber does not exceed a certain pressure. In contrast, in some embodiments, the pressure chamber also extends outside the pressure vessel when the pressure existing in the pressure chamber pressurizes the membrane so that the membrane protrudes outwardly, such as through the insertion opening, i.e., into the exterior of the pressure vessel. Thus, the pressure chamber can have a variable volume, depending on the pressure existing in the pressure chamber. The latter statement does not apply to a constant interior or internal volume of the pressure vessel.

[0038] In some embodiments, the fluid may be maintained in the pressure chamber at a pressure above atmospheric pressure despite the insertion opening penetrating the wall.

[0039] In certain embodiments, the pressure chamber is used to receive or support the distal end of a patient's residual limb inserted into the interior of a pressure vessel. Due to the fluid contained in the pressure chamber, the membrane is laterally or circumferentially close to the distal end of the limb stump or the entire limb stump. In this way, if necessary, the limb stump can be pressurized over the entire material layer, plaster bandage, etc. around the entire membrane, whereby a constant or identical pressure is preferably used per area unit. The latter may be an advantageous contribution of the present invention, since uniform pressurization may result in uniform modeling of the deformable, preferably curable material or wet plaster bandage. The contact of the membrane effected by the fluid stored in the pressure chamber may advantageously make manual modeling unnecessary or may significantly reduce the work required for this.

[0040] In some embodiments, a pressure chamber is a fluid-tight enclosed space that is completely formed or bounded by the walls and membrane of the pressure vessel. In some embodiments, the term "pressure chamber" may be replaced by the above definition.

[0041] In some embodiments, a pressure vessel is a container or space configured with a pressure chamber.

[0042] In several embodiments, the pressure vessel is a water container.

[0043] In some embodiments, the term "pressure container" may be replaced by the term "fluid container" or "water container".

[0044] In certain embodiments, the pressure vessel has a cylindrical form.

[0045] In some embodiments, the pressure chamber is designed and / or configured such that the pressure existing therein depends particularly or exclusively on the insertion depth of the limb stump into the interior of the pressure vessel, yet has a closed inlet and outlet (if provided) during the intended use of the device.

[0046] In certain embodiments, the membrane, for example the second portion of the membrane, in particular a portion having increased strength compared to the other portions (e.g. through increased wall thickness and / or due to other material properties of the composite material, coating, etc.) is arranged in the region of the insertion opening and is optionally directly or indirectly connected to the wall in a releasable or non-releasable manner, preferably fluid-tight. It preferably closes the insertion opening like a lid, as long as the pressure in the pressure chamber does not deviate significantly from atmospheric pressure.

[0047] In various embodiments, the membrane is configured to prevent fluid exchange or material exchange within the pressure vessel along an axial direction thereof.

[0048] In some embodiments, the film is always configured as a single layer in the axial and / or radial directions, but in other embodiments this is not the case.

[0049] In some embodiments, the membrane is directly or indirectly connected to the pressure vessel on a first end side of the pressure vessel, but is not connected to a second end side opposite to the first end side, however, a connector is not absent between the membrane and the end side, but preferably has a length of at least 5 centimeters (cm).

[0050] In certain embodiments, the membrane is flat or balloon-like (ie, open at one end), but not tubular (ie, open at both ends).

[0051] 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 released from the pressure vessel without the use of tools or can only be released destructively; for example, it can be permanently and releasably connected to the wall via a clamping ring or multiple clamping rings (not to be confused with a connector in the sense of the present invention, which can be provided separately) and via one or more screws. The releasability with a tool can be used advantageously in order to be able to replace the membrane, for example due to wear after repeated use. However, in these embodiments, the membrane is not intended to be released from the pressure vessel by a simple pull, pull down, etc. At the same time, the permanent fastening can advantageously ensure that the forces transmitted to the membrane by the fluid in the pressure vessel during use of the device cannot release the membrane from the pressure vessel or its wall.

[0052] In several 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 (mm) to 8 mm, particularly preferably 3 mm to 6 mm. It can consist of or contain a curable material; this is also covered by the method according to the invention.

[0053] In various embodiments, the method includes manufacturing or producing a prosthetic shaft, a portion thereof, or a complete, ready-to-use prosthetic limb based on a solidified material without having to first take a positive impression of the limb.

[0054] In some embodiments, the method does not include taking a plaster impression of the limb stump.

[0055] In certain embodiments, the wall thickness of the prosthetic shaft is preferably 2 mm to 12 mm, preferably 3 mm to 8 mm, and more preferably 4 mm to 6 mm.

[0056] In some embodiments, at least one connector is preferably fastened via one of its ends or end segments to a base region, a wall and / or a second end side of the pressure vessel, while the other end or end segment is connected to the membrane.

[0057] By using such a fastening, the connector can fix the membrane in the pressure vessel so that the membrane cannot bulge or protrude outwards through the insertion opening, which is particularly advantageous for a simple insertion of the limb stump into the interior of the pressure vessel.

[0058] The connector can be fastened to the base region, the wall and / or the second end side of the pressure vessel by means of mechanical fastening means, for example by means of hooks, clamp connections, screws, rivets, etc.

[0059] In some embodiments, at least one connector is at least 10 centimeters long, in other embodiments at least 20 centimeters long, and in other embodiments at least 30 centimeters long.

[0060] In several embodiments, at least one connector is not used for connecting the membrane in the region of the upper edge of the wall of the pressure vessel and / or for providing a fluid-tight connection between the membrane and the pressure vessel.

[0061] In some embodiments, at least one connector is connected to a reinforced portion of the membrane.The reinforced portion of the membrane may include, for example, increased wall thickness, other materials, and / or material coatings.

[0062] The reinforced portion of the membrane may include, for example, greater strength. For example, when a limb stump is inserted into or extracted from the interior of a pressure vessel of the device, increased forces on the reinforced portion, in particular frictional forces, may advantageously be dissipated by the reinforced portion of the reinforced portion through the connector.

[0063] Another part of the membrane which is not exposed or at least not completely exposed or subjected to these forces may have other material properties, for example, so that the limb stump in the membrane in the pressure chamber can fit more comfortably and softly during impression taking. In particular, the distal region of the limb stump is often particularly sensitive to pressure and should therefore be relieved as much as possible during impression taking.

[0064] In some embodiments, the reinforced portion of the membrane is connected to at least one connector on the one hand and to the wall or bottom of the pressure vessel on the other hand.

[0065] In certain embodiments, at least two connectors are fastened to the circumference of the film. Similarly, three, four, five, six or more connectors can be fastened to the circumference of the film. The connectors can be fastened to the circumference of the film at regular or irregular distances from each other.

[0066] In various embodiments, the pressure chambers of the pressure vessel comprise water or another liquid in their interior, or they are filled with water or another liquid. Liquids, due to their lack of compressibility, produce more reproducible results when taking impressions. Water is therefore the cheapest and most readily available variant.

[0067] In some embodiments, the wall of the pressure vessel is transparent in at least part thereof. This can allow visual monitoring of the insertion depth and other aspects when the plastic surgery technician takes an impression in a simple manner. In addition, light, such as ultraviolet light, may enter.

[0068] In some embodiments, the pressure container comprises one or more markings in the region of at least one transparent portion thereof. The insertion depth of the limb stump can be read at said markings.

[0069] In some embodiments, the pressure chamber is formed or limited by at least a part of the wall and the membrane. The membrane is preferably connected to the part of the wall in the region of the second end side of the pressure vessel in a material connection, a forced fit connection and / or a form fit connection. A connector or a connecting device can be provided for this purpose. Through the connector, the membrane appears to expand, drift, float or stretch undesirably towards the top or outside of the pressure vessel, wherein the membrane is not supported laterally by the wall, unlike in the interior of the pressure vessel, and in some embodiments according to the invention, it can be prevented or limited to acceptable dimensions. Therefore, the connector at least essentially selectively keeps the membrane inside the pressure vessel. This or the connector can counteract the undesirable floating of the limb stump. The floating may have an adverse effect on the pressure existing in the pressure chamber and the pressure acting on the limb stump through the membrane, because the membrane no longer contacts the stump with a uniform pressure in all parts of it surrounding the stump. However, therefore, when taking the impression, the optimal pressure is not located at the stump, so that the impression taken is not taken under the subsequent load, which occurs when walking with the prosthesis to be manufactured. Furthermore, reducing or preventing floating can help protect the membrane, which is protected from damage inside the pressure vessel by the wall of the pressure vessel. Advantageously, no other restrictions on the floating of the membrane are required, for example, when the connector is provided by the present invention, through the ring tightly connected to the thigh. Since such a ring must be provided in a variety of sizes in order to be able to use the device to take a plurality of different thickness of the limb stump, it provides a simplicity that is easy to understand for the technician. In addition to simplifying the use of the device, it also means saving of ring material, cost, etc.

[0070] In certain embodiments, the membrane is connected to the pressure vessel in the region of the insertion opening or in the region of the first end side of the pressure vessel and is additionally connected to the pressure vessel in a second region or part of the pressure vessel that is different therefrom. The second region may preferably be located in the interior of the pressure vessel and / or in the pressure chamber. The membrane may preferably be connected to the second region via a connector. The membrane may preferably only be in contact with the second region indirectly, i.e. selectively via a connector, i.e. preferably not itself in direct contact with the second region, i.e. preferably not in contact with the second region.

[0071] In various embodiments, the second region is a base region or a peripheral portion of the second end surface or end side.

[0072] In some embodiments, the connector is neither elastic nor stretchable.

[0073] In several embodiments, the length of the connector is adjustable. Its length can be adjusted via a corresponding adjustment device, which is preferably adjustable from the outside of the pressure vessel. As a result, the distance between the distal end of the membrane and, for example, the bottom area, the lower end side or the end face of the pressure vessel changes. This allows the membrane to be adjustably arranged in the pressure vessel, which in turn can allow the device of the set according to the invention to be optimally adjusted to a specific limb stump, regardless of its length.

[0074] 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 opening, ie connects it in particular to a lower end side, end surface or bottom area.

[0075] In some embodiments, the connector does not connect the membrane to the end surface, end side or middle or central region of the base region. This allows or supports relatively free configuration of the limb stump inserted into the membrane within the pressure vessel without requiring the connector to apply pressure on or through the membrane at the distal portion of the limb stump.

[0076] In exemplary embodiments, a connection is to be understood as a form-fitting connection and / or a force-fitting connection and / or a material connection.

[0077] In some embodiments, the connector is configured to maintain a distance within specified limits between a portion of the membrane connected to the connector on the one hand and a similar portion connected to the base region, lower end side or end surface of the connector on the other hand. For example, for a non-elastic connector, the distance may be constant.

[0078] In some embodiments, the membrane is directly connected to the wall.The connector may thereby be the result of a joining process, such as an adhesive bond, a rivet or the like.

[0079] In some exemplary embodiments according to the invention, the membrane in its connection region contacts the bottom region, the bottom side or the lower end side; in other embodiments, the membrane or its material does not contact the aforementioned.

[0080] In some embodiments, the membrane is made of or includes a material that has a different elasticity or stretchability in a first direction of the material than in a second direction different from the first direction, wherein the second direction may optionally be perpendicular to the first direction. In these or other embodiments, the specific elasticity or stretchability in the first and / or second direction, respectively, is achieved through fibers contained in the membrane, the fibers comprising, for example, embedded in silicone, a silicone matrix or other material, preferably a fluid-impermeable material. Such fibers may extend in the first and / or second direction of the membrane, extend substantially in the first and / or second direction and / or act substantially in the first and / or second direction. In this or other embodiments according to the invention, different elasticities or stretchability may be achieved additionally or alternatively through other designs.

[0081] The first direction may be the insertion direction of the limb stump or the longitudinal direction of the pressure vessel when the membrane is ready for use or fastened as intended on the pressure vessel.The second direction may be an angle, for example, at right angles to the first direction.

[0082] The fibers extending or traveling or acting in the first direction may optionally be non-stretchable; or may be stretchable only to a small extent. Optionally, they are less stretchable than the fibers optionally provided to travel, extend or act in the second direction. If present, the fibers traveling, acting or extending in the second direction may be stretchable, they may be more stretchable or more elastic than the fibers in the first direction; their stretchability may optionally correspond to the stretchability of the fibers extending in the first direction. The fibers extending in the first direction are optional, and the fibers extending in the second direction are also optional. The stretchability or elasticity of the fibers may correspond or be related to the stretchability or elasticity of the membrane. The fibers may be made of or contain nylon. They may be made of a tensile material, in particular a material that is more tensile than the material in which it is embedded. Such a design, for example preventing or significantly limiting longitudinal stretching (which may optionally be the first direction), while allowing the membrane to stretch in the circumferential or radial direction to adapt it to the limb stump, may also advantageously counteract undesirable floating of the limb stump. In addition, the relationship between the depth of the pressure chamber and the insertion depth in the membrane can advantageously remain the same. Moreover, the above-mentioned multi-piece sealing ring or thigh sealing ring can optionally be omitted. In addition, only one membrane can be used to produce a prosthetic shaft according to the invention at a whole row of limb stumps with different cross-sectional thicknesses. The membrane advantageously fits tightly enough with thick as well as thin socks to prevent the membrane from creases as described herein. Even when longitudinal stretchability is prevented or limited, the cross-sectional / circumferential stretchability that the membrane can include in various embodiments according to the invention advantageously contributes to this.

[0083] In several embodiments, the thickness of the film is partially, at least partially or completely or as a whole less than 2 mm, preferably less than 1.5 mm, particularly preferably less than 1 mm. In some embodiments, the film has this thickness over at least 90% of its length, preferably over at least 95% of its length (in the longitudinal direction during use). At this thickness, it distorts the difference between the actual geometry of the limb stump and the curable material in a negligible way at best.

[0084] In certain embodiments, the wall of the pressure vessel is made of plastic, such as plexiglass or polycarbonate, or includes one or more of these materials.

[0085] In certain embodiments, the connector, the membrane and / or the base region comprises at least one thread for screwing the membrane or a component connected thereto directly or indirectly to the pressure vessel.

[0086] In certain embodiments, the membrane is made of or comprises a material comprising fibers embedded in or otherwise attached to a matrix in a first direction and / or a second direction thereof.

[0087] In certain embodiments, the membrane optionally comprising a matrix or its matrix is ​​made of or contains silicone.

[0088] In certain embodiments, some or all of the fibers have a wavy, curved, or zigzag path.

[0089] In certain embodiments, the film is non-stretchable or inelastic in its first direction and / or second direction.

[0090] In some embodiments, "non-stretchable" or "non-elastic" means that the elastic modulus of the corresponding component (connector, film, fiber, etc.) is at least higher than 700N / mm. 2 , preferably higher than 1000N / mm 2 , particularly preferably higher than 2000 N / mm 2 .

[0091] In certain embodiments, "non-stretchable" or "inelastic" means that the stretchability of each component (connector, membrane, fiber, etc.) does not exceed 20%, preferably does not exceed 10%, preferably does not exceed 5%, and particularly preferably does not exceed 2% of its length before the component tears or breaks.

[0092] In certain embodiments, the membrane, its fibers, and / or connectors have an elastic modulus such as nylon.

[0093] In certain embodiments, in addition to the upper and / or proximal portion of the membrane and / or in addition to the portion of the membrane located in the area of ​​the insertion opening facing the pressure vessel, a portion of the lower and / or distal portion of the membrane and / or a portion of the membrane located in the area facing away from the insertion opening of the pressure vessel and / or facing the bottom area is directly or indirectly, preferably releasably connected to or connected to a wall of a fluid container, for example a bottom area or a side area thereof, by using at least one connector, referred to herein as a distal connector.

[0094] What is described herein with respect to connectors, in particular with respect to their materials, length, elasticity, stretchability and other properties, in particular the material properties, also applies to the connectors referred to herein as distal connectors, unless this gives rise to any contradiction recognizable by a person skilled in the art.

[0095] The distal connector may be designed and / or provided according to any embodiment of the present invention, as disclosed in WO 2016 / 135320A1, the disclosure of which is hereby also incorporated by reference in its entirety as the subject matter of the present application.

[0096] In some embodiments, the connector and / or distal connection is completely located inside the pressure vessel without contacting the exterior of the pressure vessel.

[0097] In some embodiments, the pressure vessel and / or the lines communicating therewith include a pressure gauge that determines or measures the pressure present in the pressure chamber. The orthopaedic technician can orient himself based on the measured pressure, for example, with respect to the pressure increase described above.

[0098] In several embodiments, the membrane is deformable inwardly or outwardly, preferably elastically stretchable. In other cases, it is elastic in one direction; in other cases, it is elastic in one direction. But it is not elastic or relatively or significantly less elastic in a direction particularly perpendicular thereto.

[0099] The device of the set according to the invention or any component thereof, in particular the membrane and the film according to the invention, may be provided with one or more features in any combination as disclosed in WO 2016 / 135320 A1, the entire disclosure of which is hereby incorporated by reference as the subject matter of the present application.

[0100] In some embodiments, the film is made of a fluid-impermeable material, in particular a watertight material. It may be made of or contain silicone. It may be made of or contain fiber-reinforced silicone. Copolymers or rubber may be provided instead of silicone.

[0101] In embodiments of the kit according to the invention, at least one energy source is or comprises a radiation source, in particular a light source, preferably an ultraviolet (UV) radiation source.

[0102] In some embodiments, the at least one energy source includes at least five, preferably at least six, eight or more UV radiation sources.

[0103] In some embodiments, the UV radiation source emits light having a wavelength of 405 nanometers (nm), preferably radiation having a wavelength of 395 nm to 415 nm, and particularly preferably radiation having a wavelength of 400 nm to 410 nm, or emits only such radiation.

[0104] In some embodiments, at least one energy source for curing or partially curing is connected to a portion of the pressure vessel.

[0105] In several embodiments, at least one energy source for curing or partial curing is not connected to the medical device, in particular not to a part of the pressure vessel.

[0106] In some embodiments, at least one energy source is disposed outside of the pressure vessel or pressure chamber of the medical device.

[0107] In several embodiments, the pressure chamber of the medical device comprises water as fluid. In particular, this may be distilled water, water obtained by reverse osmosis or water treated in a different way.

[0108] In some embodiments of the kit according to the invention, the medical device or part thereof comprises at least one portion transparent to radiation, in particular optical radiation or UV light radiation, in particular in the region of a wall of the pressure vessel, for example in the form of one or more windows.

[0109] In some embodiments, the medical device or at least a portion thereof (particularly the wall) is made of translucent UV-resistant acrylic glass (e.g. ) is made of or includes translucent UV resistant acrylic glass.

[0110] In some embodiments, in particular in embodiments of a kit according to the invention, the material is or comprises a light-curable resin, preferably an acrylic resin.

[0111] In some embodiments, particularly embodiments of the kit, the material is or includes a photopolymer.

[0112] In some embodiments, particularly in some embodiments of the kit, the material contains an odorant, which can be used to give the prosthetic shaft a pleasant smell, such as the fresh smell of lemon, etc., when in use.

[0113] In several embodiments, in particular in several embodiments of the set, the material comprises reactive additives. These may in certain embodiments lead to the fact that, after initiation by UV light, areas not directly or less irradiated with UV light also cure.

[0114] In some embodiments, particularly some embodiments of the set, the material is applied to and / or incorporated into a braid, tube, sock, or stocking.

[0115] The invention also includes a knit, tube, sock or stocking or a mesh (these terms are used synonymously in several embodiments), particularly as described herein, onto or into which a material according to the invention is applied and / or incorporated.

[0116] In some embodiments, in particular in some embodiments of the set, the braid, tube, sock or stocking is elastic, at least transversely elastic or elastic in the circumferential direction, so as to be able to adapt to multiple limb stump circumferences of different patients. In the best way, i.e. preferably as crease-free as possible. Here, it can also be elastic in the longitudinal direction, although this is not the case in some embodiments. However, in addition to or as an alternative to the optional elasticity in the circumferential direction, the braid, tube, sock or stocking can have its circumferential size changed by using fibers or strips (e.g. fibers). As described herein.

[0117] In some embodiments, in particular in some embodiments of the set, the knitted fabric, the tubular element, the sock and / or the stocking is multi-layered, ie comprises different layers.

[0118] In some embodiments, in particular in the embodiment of the set, the braid, tube, sock and / or stocking comprises or is composed of multiple layers, preferably at least four layers, preferably at least five or six layers. In some embodiments, these layers may also be referred to as "sandwich structures".

[0119] In some embodiments, the braid, tube, sock, mesh and / or stocking has, for example, on its inner side or facing it, layers that are finer than some or all of the layers that are arranged radially more outward. In this way, light from a radial direction can first pass radially from the outside through the tightness of the fabric to the inside. Thus, in many embodiments, the fineness of the mesh can increase towards the limb stump. In other embodiments, this can be exactly the opposite. The latter embodiments are particularly suitable for curing by radiating light from radially inward to radially outward.

[0120] In some embodiments, particularly embodiments of the set, the layers include or consist of fiberglass.

[0121] Glass fibers can advantageously provide the necessary strength of the finished prosthesis shaft, since they have high flexural, tensile and compressive strengths at a relatively low density, as well as high resistance to chemical and biological influences. In addition, glass fibers have thermal insulation and water-repellent properties.

[0122] In several embodiments, the kit comprises a liner and / or the liner is used in a method according to the invention, in particular as respectively disclosed herein.

[0123] In some embodiments, the liner may include or be connected to a radiation source, in particular a light source or a light guide, which is provided and / or suitable for curing the material according to the invention. In these embodiments, it may also be referred to as a "curing liner". In these embodiments, light is thus radiated from the inside to the outside during curing in the film, i.e. from the liner towards the film, wherein the curable material is arranged between the liner and the film.

[0124] In many embodiments, the liner is available in a set or kit or otherwise in multiple sizes, for example exactly or at least in 3, 5, 10 or 20 different sizes. Preferably, this is used to provide a suitable liner for each residual limb structure of the patient from a set or kit that can be used for patient care.

[0125] In some embodiments, light, in particular UV light, can be guided by glass fibers. In such embodiments, one or more glass fibers themselves can be the energy source. Alternatively or additionally, one or more glass fibers can be used as energy lines, such as light guides. They can be connected to an energy source, such as a light source. They can emit light themselves. Connectors, connections, etc. necessary or suitable for this purpose can be provided and / or can also be covered by the present invention.

[0126] In some embodiments, a layer of the braid, tube, sock and / or stocking or optionally a layer of the lining, in particular the outer layer which is preferably facing away from the patient's limb stump during the intended use, can consist of or include an energy conductor, for example a light-conducting glass fiber. By light introduced into or conducted by or along this layer, the material, in particular a resin, preferably an acrylic resin or a photopolymer, can be cured, for example by light emission. An external light source or a light source irradiated from the outside into the medical device or its pressure vessel can thus be omitted.

[0127] In order to enable better light emission, any sheathing of the glass fiber that may be present may optionally at least partially comprise light-transmitting holes, windows and / or the like.

[0128] In some embodiments, materials, particularly resins, preferably acrylics or photopolymers, may be caused to cure by using light conducted through or along layers within a braid, liner, tube, sock and / or stocking that include or are emitted by glass fibers.

[0129] The “sandwich structure” can advantageously contribute to a uniform structure of the prosthesis shaft and thus ensure increased wearing comfort for the wearer of the prosthesis shaft.

[0130] Providing multiple layers overlapping each other in radial direction contributes to the fact that intersection points, for example, mesh structures of different layers do not tend to overlap each other, or if present, accumulation of material in radial direction does not create avoidable pressure points, thereby impairing the patient's future wearing comfort or the generation process.

[0131] In some embodiments, particularly some embodiments of the set, the plurality of layers comprises or consists of a mesh portion or a woven portion.

[0132] In several embodiments, in particular embodiments of the set, one of the layers, in particular the innermost layer, is made of or comprises an elastic fabric. Preferably, this is a white or light colored fabric, in order to increase the light output. Preferably, in these embodiments, the layer facing the patient's limb stump is made of a very fine mesh or fine pore material, in order to advantageously achieve the smoothest possible inner surface of the shaft. This may facilitate the later requirement for a step-free inner side, which is required for applying a vacuum.

[0133] In some embodiments, the pad may be wet, such as soaked with water.

[0134] In several embodiments of the set, the innermost layer is designed to be reflective or reflective on its outer side, such as by a mirror film.

[0135] The mirror film can in particular increase the brightness of the UV lamp and improve the penetration of the optionally multiple deformable layers that can be cured by the energy source. This may also help to shorten the curing time.

[0136] In some embodiments of the kit according to the present invention, the kit includes a liner, such as disclosed herein, which is preferably designed to be light reflective or reflective on its exterior, such as through a mirror film. The patient can wear the liner on the skin. The liner can be arranged between the limb stump and the curable material.

[0137] In certain embodiments of the set, the outermost layer or layers have a coarse mesh structure, such as a Chinese finger trap structure, which is particularly suitable and intended to be translucent.

[0138] In some embodiments, the material is connected to a connection element, in particular a screw connection, for a distal prosthetic component, in particular before it hardens, or the material surrounds the connection element in sections or it is embedded in the material.

[0139] In some embodiments of the kit according to the invention, the membrane of the medical device is at least partially permeable to radiation from the energy source, in particular light, preferably UV light, for example translucent or transparent. In certain embodiments of the set according to the invention, the set comprises a control device, which is configured to limit the energy source so that the temperature inside the braid, hose, socks or stockings does not exceed 40° C. Corresponding measurements can be made in advance and the process can be controlled accordingly. If a temperature sensor is provided, a corresponding control system can be set. This advantageously ensures that the patient does not get too hot when the prosthetic shaft is installed and therefore feels more comfortable. In addition, skin damage caused by heat can be prevented in this way.

[0140] Additionally or alternatively, a temperature sensor may be used as part of the thermal monitoring device.

[0141] In several embodiments of the method according to the invention, the method further comprises the step of inserting the limb stump into a bag opening or protrusion formed by a membrane inside the pressure vessel, so that the limb is at least partially surrounded by the membrane and around its entire circumference, and so that a deformable material that can be solidified by an energy source is at least partially present between the limb stump and the membrane.

[0142] In some embodiments of the method, the material may be in contact with the membrane and / or the skin of the limb stump. Alternatively, the material may be separated from one and / or the other by a separation layer, such as made of a film. Likewise, the above-mentioned liner may be provided as a separation layer.

[0143] The pad disclosed herein can perform a cooling function. For this purpose, it can include a cooling component, a connection for a cooling medium (such as a cooling liquid), a cooling medium can flow through it, and the like.

[0144] In various embodiments of the method according to the invention, the limb stump may be surrounded or wrapped by the material before it is introduced into the pressure vessel. Alternatively, the limb stump may first be in direct or indirect contact with the material in the pressure vessel.

[0145] In embodiments of the method according to the invention, the method comprises as a further step: removing material from the limb stump and its surroundings and subsequently curing or further curing the material using an energy source external to the pressure vessel.

[0146] In some embodiments, the method according to the present invention further comprises the step of removing material from the limb stump and its surroundings using an energy source within the pressure vessel after the material has solidified.

[0147] In certain embodiments, the resin used reacts only when irradiated with UV light and then cures.

[0148] In some embodiments, the kit according to the invention further comprises a textile stocking impregnated with resin, in particular a textile stocking of various sizes, preformed under vacuum and / or prepackaged in a light-tight bag.

[0149] Advantageously, when curing materials inside the device, such as resins irradiated by a UV light source, the resins may be cured without generating strong odors and / or heat.

[0150] In some embodiments, the resins used are provided in different colors.

[0151] In several embodiments, the prosthetic shaft is cured, for example by UV light, and can be used immediately, in particular without further manual processing, optionally at least as far as the prosthetic shaft itself is concerned. This may not affect the attachment of components required to obtain a ready-to-use prosthesis from the prosthetic shaft. Such components may involve screws, valves, etc.

[0152] In some embodiments, further processing of the cured prosthetic shaft is provided, for example by UV light, in particular by thermal deformation.

[0153] In some embodiments, the material provided with the device is cured, for example, by UV irradiation, and is directly connected to other prosthetic components via a distal screw, while in other cases it is not.

[0154] In some embodiments, the film includes a radiation conductive, energy conductive, and / or light conductive layer or a radiation conductive, energy conductive, and / or light conductive portion.

[0155] In some embodiments, the film comprises a radiation-emitting, energy-emitting and / or luminescent layer or a radiation-emitting, energy-emitting and / or luminescent portion, or a layer or portion that can be triggered to do so. Thus, it can be provided that the film incorporated in or forming a material (such as disclosed herein), for example between two layers thereof, comprises at least one light source or UV light source or other radiation device that is actuated as required and thus triggered to emit light, radiation, etc. The present invention provides a UV emitter that can be used as a light source in the film and can cause it to emit light when required, but preferably does not emit light.

[0156] In several embodiments, the device comprises a voltage source or a connection thereof for supplying 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 can be used as a voltage source for a radiation unit or a light source, for example.

[0157] In some embodiments, the device comprises a mount for at least temporarily securing the radiation source to a mounting bracket of the device, such as a wall thereof.

[0158] In some embodiments, the radiation source is an induced current source.

[0159] In several embodiments, the light source or radiation source comprises or is in contact with a heat accumulator, for example made of aluminum. They can counteract overheating of the radiation source and thus help to extend its service life.

[0160] In certain embodiments, in addition to energy and / or curable material or as its alternative, kit according to the present invention comprises one or more shapes or mechanical shapes, such as blocks or staples, such as supracondylar nails. These shaped bodies can be, for example, made of carbon, plastic, fiber reinforced plastic, particularly carbon fiber reinforced plastic or silicone. They can be provided and / or suitable for being directly applied to the patient's skin or being placed and / or fixed there, for example using a film. Therefore, they can reduce, for example, the medial-lateral distance by applying pressure. The shape is used to shape the prosthesis axis, thereby increasing the wearing comfort of the patient using the finished prosthesis, for example, by alleviating the patient's flexor tendon.

[0161] The shaped bodies can be designed to change shape or adapt to the patient, for example by heating.Their thermal adaptation can be part of the method according to the invention.

[0162] In some embodiments, the kit includes a computing device. The latter may be part of the medical device or connected to it physically or in a signal communication manner. However, it may also be provided independently of the medical device.

[0163] The computing device may be a control device and may include input devices (e.g. keyboard, scanner, mouse, interface, sticker, storage unit, interface (Bluetooth, etc.)) and output devices (e.g. monitor, display, printer, storage unit, interface (Bluetooth, etc.)) and / or data storage.

[0164] The computing device can optionally be configured to monitor and / or limit - for example based on data stored in a data memory or based on input data which can be entered via an input device - technical parameters, such as a (minimum) duty cycle of the radiation source or light source, its total operating time (for example, distributed over predetermined time intervals), a maximum duty cycle, the power of the radiation source, a predetermined temperature at the light source and / or at the patient, a number of operating cycles, etc.

[0165] All features and properties stated for the materials of the set also apply to the materials according to the invention without limitation and vice versa.

[0166] In some embodiments of the kit according to the present invention, the bag is a light-impermeable and air-impermeable bag.

[0167] In various embodiments, the kit includes a plurality of braids, tubes, socks or stockings as described herein. These may be present in one or more bags.

[0168] In some embodiments of the kit, at least two or more of the braids, tubes, socks, or stockings differ from one another in at least one corresponding circumference, such as at the same height, at the same distance from the distal end, etc.

[0169] In several embodiments of the kit, at least two or more of the braid, tube, sock, or stocking have the same length (in the distal-proximal direction).

[0170] Some or all embodiments according to the invention may have one or more advantages mentioned above or below.

[0171] By using the invention, it is advantageously possible for the first time to load the residual limb of a standing patient, so that not only an impression of the patient's limb residual limb can be taken reliably and, above all, reproducibly, but also a prosthetic shaft can be generated at the same time.

[0172] The invention thus allows the impression to be used as a basis for a shaft that is conveniently fitted to the patient, especially when walking and standing. In the process, less craftsmanship skills are required than have been required to date. The steps that are still necessary after obtaining a conventional plaster impression in order to realize the prosthetic shaft can be omitted.

[0173] The invention thus makes it possible to manufacture shafts for prostheses of human upper and especially lower limbs in an objective manner.The invention thus makes it possible to manufacture suitable prosthetic shafts, wherein the purely subjective and manually performed cost-intensive activities required by prior art methods can be avoided.

[0174] Compared to the prior art, the invention makes it possible to manufacture shafts for prostheses in an objective manner. This ensures better care or attention due to an improved fit (form) and can reduce production costs, since expensive manual post-processing and adaptation are not required or only rarely required. In addition, patient care can be accelerated, since time-consuming adaptation steps can also be greatly reduced (at least in number) or even completely eliminated.

[0175] Another advantage of the present invention may be that when using a curing material such as a resin soaked stocking, the cured shaft can be used immediately as a prosthetic shaft. The time-consuming and extensive manual skills required to obtain an impression and shape can be advantageously omitted. This helps save time and the cost of materials and labor.

[0176] Another advantage of the present invention is that the airtightness of the prosthesis shaft can be ensured by properly selecting the amount or ratio of the laminate or braid and the resin. This can ensure a good fit of the prosthesis to the patient's limb stump without the need for additional devices. This may help save time and cost, and improve the wearing comfort of the patient using the prosthesis.

[0177] The deformable material curable by the energy source, such as the resin in which the stocking is soaked, preferably does not reach more than 40°C during curing, which advantageously ensures that it does not become too hot for the patient and that the patient feels comfortable fitting the prosthetic shaft.

[0178] Complete curing of the prosthetic shaft can be achieved quickly, for example under UV light at a wavelength of 405 nanometers, particularly in 5 minutes or less, and without complications, which can also advantageously contribute to the patient's comfort when fitting the prosthetic shaft.

[0179] A further advantage is that the use of the present invention to manufacture prosthetic shafts can significantly avoid waste and save electricity and work time compared to other prior art manufacturing methods. For example, the inventors saved 85% of waste, 92.5% of electricity and 80% of work time when generating prototypes compared to traditional procedures.

[0180] Another advantage may be that the prosthetic shaft produced by the present invention remains thermoplastically deformable even after curing, for example to allow an orthopedic technician to make minor adjustments to the patient's limb stump after production.

[0181] The present invention is explained exemplarily below with reference to the accompanying drawings, in which the same reference numerals represent the same or similar parts. In the drawings (some of which are highly simplified), the following applies: BRIEF DESCRIPTION OF THE DRAWINGS

[0182] Figure 1 A side view showing a longitudinally cut medical device of a kit according to a first embodiment of the present invention;

[0183] Figure 2a ,b shows another cross-sectional view Figure 1 Various embodiments of the device;

[0184] Figure 3 A side view showing a longitudinally cut medical device according to another embodiment of the present invention;

[0185] Figure 4 A side view showing a longitudinally cut medical device of a kit according to another embodiment of the present invention;

[0186] Figure 5a A schematic diagram showing a braided fabric in one embodiment with a material incorporated into or applied to the braided fabric;

[0187] Figure 5b Shown from the side Figure 5a Schematic diagram of weaving;

[0188] Figure 6a , 6b A schematic diagram showing a possible principle of weaving in yet another embodiment;

[0189] Figure 7a Showing another embodiment of the braid;

[0190] Figure 7b , 7c Shows a braid with one or more layers of mesh or braid, similar to Figure 7a Representation of;

[0191] Figure 8a Shows a schematically simplified form of the first embodiment;

[0192] Figure 8b Display has Figure 8a A schematic simplified cross-section of the limb stump of a figure as seen from the top;

[0193] Figure 8c A simplified schematic diagram showing a shape in another embodiment;

[0194] Figure 8d show Figure 8c A simplified schematic top view of the shape of ; and

[0195] Fig. 9 A simplified schematic diagram showing an exemplary process of a method according to the present invention for applying a deformable material curable by an energy source to a limb; or in one embodiment, a simplified schematic diagram for manufacturing a prosthetic shaft or a portion thereof for a patient's limb stump. DETAILED DESCRIPTION

[0196] The first embodiment shows a pressure vessel 1 having a pressure chamber DK, a wall 3 and a membrane 5. The membrane 5 has a first or proximal membrane portion 5a, which is connected to the upper edge 7 of the wall 3. In this embodiment, for example, the first membrane portion 5a can be optionally reinforced, which is shown by a thicker wall thickness (in Figure 1 The reinforcement design can alternatively or additionally be achieved by a different choice of material, fiber-reinforced composite materials, material coatings or in other ways.

[0197] Furthermore, the membrane 5 comprises a second or distal membrane portion 5b which is arranged in the 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 the thinner wall thickness (in Figure 1 outlined by a thinner line thickness).

[0198] The two different membrane parts 5a, 5b are used for different load situations of the membrane 5. When the limb stump KS is inserted and removed into the membrane 5 and thus into the pressure vessel 1, the first membrane part 5a loads the forces between the limb stump KS and the membrane 5, in particular by friction. Due to this increased load, the first membrane part 5a can optionally be reinforced. In particular, the second membrane part 5b has a sealing function and a holding function for the limb stump KS in the pressure vessel DK with a lower load than the first membrane part 5a.

[0199] In this exemplary embodiment, two optional connectors 53 are optionally configured at the connection site or interface between the first membrane portion 5a and the second membrane portion 5b or in the transition area between the two, and their functions are described in more detail below. Specifically, the connector 53 is connected to the first membrane portion 5a (optionally alternatively in addition to Figure 1 positions other than those shown).

[0200] The connection between the connector 53 and the membrane part 5a or 5b is indicated by the reference numeral A. Figure 1 In the example of , connection A may optionally be located at a height H and / or a distance B below the upper edge of wall 3 .

[0201] The 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.

[0202] Connecting area A Figure 1 The left side is enlarged.

[0203] Preferably, the membrane 5 is releasably fastened to the base region 4a , or to a region of the wall 3 , for example in an upper, middle or lower region thereof, using at least two connectors 53 extending from a proximal portion of the membrane 5 .

[0204] The proximal region of the membrane 5 is understood in this context by way of example to be the upper third of the membrane 5 or a region in the upper third of the membrane 5 .

[0205] The proximal region of the membrane 5 can be identified as facing the insertion opening 9 or being located in the vicinity thereof.

[0206] It can be seen that the area where the membrane 5 is connected to the connector 53 is not located in the central distal part 58 of the membrane. Since the connector prevents floating of the limb stump KS, this advantageously prevents radial pressure on the membrane 5 in the distal part. This pressure can affect the radial compression of the limb stump KS stuck in the membrane 5, which can lead to undesirable geometry of the plaster impression generated, especially in the distal stump part. Providing the connector 53 in the proximal part can help avoid such deformation of the distal part of the limb stump. This can advantageously lead to the correct geometry of the plaster impression. Although the connector 53 exerts radial pressure on the limb stump KS in the proximal part due to its connection to the proximal end of the membrane, however, there (i.e., the proximal end or about the distal end) Figure 1 "At the top"), the limb stump KS comprises a more rigid anatomical structure and is less susceptible to radial compression, which in some embodiments may be avoided by the present invention.

[0207] like Figure 1 As shown, the pressure vessel 1 may be optionally purely cylindrical and may optionally include a first end side 2 (at Figure 1 The top of the second end side 4 (at Figure 1 ). Figure 1 The second end side 4 in the exemplary embodiment of is fluid-tight against the exterior A by means of a bottom plate or base region 4 a. The bottom region 4 a can be made of the same material as the wall 3 . It can be made in one piece with the wall 3 .

[0208] The membrane 5 separates the fluid chamber or pressure chamber DK of the pressure vessel 1 in a fluid-tight manner from the outside of the fluid chamber or pressure chamber DK, or exemplarily from the outside A (ie the pressure environment), or Figure 1 The limb stump KS is shown against an inserted membrane 5 or surrounded by the membrane 5 .

[0209] The membrane 5 may be connected to the pressure vessel 1 in a fluid-tight manner at the upper part of the wall 3 , typically at a circumferential edge 7 of circular, rectangular, square or different shape, or at another location.

[0210] The upper edge 7 exemplarily lies in a plane in which the insertion opening 9 of the pressure vessel 1 lies or it delimits said insertion opening 9 at its circumference. The insertion opening 9 alternatively lies in a plane H indicated by a dashed line.

[0211] The insertion opening 9 is used to insert the limb KS surrounded by the curable material into the interior I of the pressure vessel 1 .

[0212] The interior I is the volume of the pressure vessel 1 which is bounded by the wall 3. It extends from the second end side 4 which is sealed fluid-tightly with the bottom area 4a to an insertion opening which is denoted by 9 and is outlined by a dashed line.

[0213] The pressure chamber DK is filled with a fluid, here by way of example with a liquid F outlined by dots.

[0214] exist Figure 1 , the device 100 is shown in a state in which a limb stump KS of a standing patient, which is outlined very schematically, is inserted into the interior I so that it is surrounded at least at its distal part by a membrane 5. The membrane 5 contacts the curable material (covering or on the stump KS) like a second skin, wherein further layers, such as padding or the like, may be arranged between the curable material and the membrane 5.

[0215] exist Figure 1 In the example, the limb stump KS bears the full body weight of a standing patient. The amount of liquid F is measured relative to the known volume of the interior I or pressure vessel 1 so that the stump KS can enter the pressure vessel 1 through the insertion opening 9 at least so deep or far that the entire area on which the curable material is present contacts the membrane 5; at least in relation to the production of the prosthesis axis. At the same time, the amount of liquid F is measured so that the distal end of the limb stump KS (at Figure 1 The bottom of the pressure vessel 1 does not touch the bottom of the pressure vessel 1 or support itself on the bottom. In this way, it is ensured that the patient rests on the pressure of the fluid with the inserted limbs and that the curable material is subjected to the same pressure through the membrane 5 at each point.

[0216] like Figure 1 As shown, when no limb stump KS is inserted into the pressure container 1, the membrane 5 rises or floats due to the pressure of the fluid (here, liquid), and a liquid level (not shown) appears. Figure 1 The shape of the membrane 5 shown in represents the form that the membrane 5 takes under load, i.e. when the membrane 5 fits tightly against the inserted limb stump KS and is pushed under elastic tension. Figure 1 In the example of - the depth of entering the interior I towards the bottom area 4a.

[0217] exist Figure 1It can also be seen in FIG. 1 that the wall 3 and the membrane 5 allow a desired pressure to be built up in the pressure chamber DK of the pressure vessel 1, since both prevent fluid exchange between the pressure chamber DK and the exterior A or fluid leakage from the pressure chamber DK. However, they do not allow the pressure to escape or dissipate from the pressure chamber DK.

[0218] like Figure 1 As shown, the pressure chamber DK is thus optionally formed by the membrane 5 and at least by a portion of the wall 3 , which here also includes the bottom region 4 a of the end face 4 .

[0219] also, Figure 1 An optional outlet 19' is shown in the side wall or wall 3 of the pressure vessel 1. If provided, this outlet may also be located elsewhere at the pressure vessel 1, for example, at its bottom region.

[0220] The outlet 19' connects the interior I in the region of the pressure chamber DK to the exterior A of the pressure vessel 1. It allows the filling level and / or the pressure within the pressure chamber DK to be modified specifically, for example by draining or filling with fluid from the pressure chamber DK via the outlet 19'. For this purpose, the outlet 19' is provided with a valve or a stopcock, not shown in detail, which can be closed liquid-tight. Regardless of its designation as an outlet, the latter can also be used to introduce fluid and thus for filling the pressure chamber DK.

[0221] exist Figure 1 In the embodiment of the invention, the membrane 5 can optionally be connected to the base region 4a purely by way of example via a connector 53 or a connector 53. The connector 53 can optionally be not (or only slightly) elastic or stretchable. The membrane 5 can also optionally be not (or only slightly) elastic or stretchable in the longitudinal direction.

[0222] Connector 53 optionally allows membrane 5 to be moved proximally ( Figure 1 Thus, a more or less annular floating element 81, which is however closed in its circumference, is present at the second end side 2. Figure 1 In the cross-sectional view in FIG. 8 , the float 81 will be seen as a protrusion on the left and right side of the arm. Stump KS. To prevent this float 81, a connector 53 can be provided.

[0223] The membrane 5 is in close contact with the limb stump KS (or a layer pulled on a curable material, padding, etc.) at a contact point surface 83, which is more or less annular, but closed around its circumference. The contact point surface 83 is a circumferentially closed line or surface that includes the point where the limb stump KS has final or closed proximal contact with the membrane 5. The contact point surface may also be referred to as a contact area or contact line.

[0224] At the same time, the membrane 5 can optionally contact or be fixed to a transition section 85 at its radial circumference in the region of the second end side 2 of the wall 3, which is also closed on its circumference. The transition section 85 can be understood as the region where the limit of the pressure chamber DK passes through or merges from the limit of the wall 3 to the limit of the membrane 5. This is Figure 1 As can be clearly seen in FIG. 8 , the pressure chamber DK is limited only by the wall 3 below the tip of the arrow of the reference numeral 85 and only by the membrane 5 above, and the membrane 5 cannot support itself on a part of the wall 3 .

[0225] The fixing of the membrane 5 in the transition portion 85 can be done in various ways. However, in this and any other embodiment, it is not fixed by the connector 53. The fixing of the membrane 5 by the connector 53 takes place in the region of the connection A.

[0226] The float 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 point surface 83 and the transition portion 85 are at the same height H (H is the height above the contact point surface 83). The bottom area 4a) is composed of Figure 1 Based on the experience of the inventors of the present invention, once this happens, the optimal pressure conditions for taking the impression occur or are provided.

[0227] Even if the length of the connector 53 is not adjustable, it advantageously ensures that floating 81 does not occur beyond a predetermined degree of height H. The predetermined range may be 1 to 4 centimeters, particularly preferably about 2 centimeters.

[0228] Figure 1 The distal connector 91 is shown, although it is not Figure 3 , but a distal connector 91 may optionally be provided in any embodiment.

[0229] Figure 2a Shows Figure 1 Another section BB of the device 100 according to the invention is shown. Section BB shows the device 100 in cross section at a longitudinal position where the connector 53 is connected to the membrane 5. The viewing direction of section BB is Figure 2a In the downward direction, the base region 4a is pointed. Figure 2a In the embodiment, four connectors 53 are configured to be offset by about 90 degrees in the circumferential direction. Alternatively, the connectors can be arranged irregularly around the circumference. They can also be placed in any number and at any distance from each other (about every 5 cm along the circumference).

[0230] The connector 53 is fastened at its one end to the membrane 5 and at its other end preferably to the base region 4a. The limb stump KS is arranged in the center of the membrane 5.

[0231] The connectors 53 can be connected to one another, for example they, for example all, radiate in an annular set or be connected to annular devices which are respectively guided around the circumference of the membrane 5 .

[0232] Figure 2b Shows Figure 2a The configuration of the embodiment of the present invention is similar to that of the embodiment of the present invention, but with six connectors 53, each of which is offset by about 60 degrees in the circumferential direction. Alternatively, the connectors may be irregularly configured or scattered on the circumference.

[0233] Figure 3 A longitudinal cutting device 100 according to another embodiment of the invention is shown from the side. In this embodiment, a connector 53 is fastened to the wall 3 of the pressure vessel 1. Functionally, the connector 53 fastened to the wall has the same function, namely preventing undesired floating of the membrane 5. During use of the device 100 according to the invention, fastening to the wall 3 can have advantages in terms of assembly and / or operation.

[0234] Figure 4 A longitudinally cut medical device 100 of a kit according to another embodiment of the present invention is shown from the side.

[0235] Reference is made to the statements concerning the preceding drawings.

[0236] like Figure 4 As shown, the membrane 5 is elastically filled to the depth of the interior I of the base region 4a due to the load of the inserted limb stump KS of the patient and thus adjoins or contacts the base region 4a. In particular, no wrinkles or bulges are generated.

[0237] exist Figure 4 On the left and right sides in the example of , the light source or UV light source 95 is configured as an example of an energy source or radiation source in the pressure chamber DK, and is exemplarily configured here on the inner wall of the pressure chamber DK. Alternatively or additionally, they are arranged outside the pressure chamber DK and / or inside the pressure container 1, but not in the pressure chamber DK and / or not in the liquid F. Alternatively, they are arranged outside the pressure chamber DK and / or outside the pressure container 1 and are not connected to the medical device 100.

[0238] If there are a plurality of UV light sources 95, as an example of an energy source or radiation source, the UV light sources 95 can be evenly distributed around the circumference or arranged at different distances from each other. For example, they are arranged over the entire length of the pressure chamber DK, i.e. with respect to Figure 4 in the up-down direction, or only in part of its length, and / or arranged on the entire circumference, or only in part of it.

[0239] In alternative or additional embodiments, the wall 3 of the pressure vessel 1 and its pressure chamber DK may have energy permeable and / or translucent parts similar to windows, and the UV light source 95 may be arranged outside the pressure vessel 1. This is also included within the scope of the present invention.

[0240] The limb stump KS is covered or covered with a stocking S which in turn is soaked in resin to form a prosthetic shaft, or consists of resin and / or another curable material, or contains resin and / or another curable material. Together with the limb stump KS, the latter is inserted through the opening of the pressure chamber DK and into the membrane 5.

[0241] Optionally a cup-shaped object, such as a carrier tower 99, for example made of plastic, may be provided to be inserted into the membrane 5 together with the limb stump KS, or to be present in the pressure chamber DK and thus to contain the fluid, and in either case to relieve the distal end of the limb stump KS from the fluid pressure acting on it at the distal end.

[0242] The object, if present as a set or part of a set, may comprise, for example, at least in its uppermost section or edge, a hole 99' or other radiation-permeable portion, in particular a translucent portion, such as a translucent portion. Window, here allowing light, in particular UV light from a UV light source 95, to penetrate to the tip of the limb stump KS.

[0243] The light radiation 97 from the plurality of UV light sources 95 is shown by wavy lines. It causes the resin or other suitable material soaked in the stocking S or otherwise placed around the limb stump KS to be completely or at least partially cured. The stocking S, which has been cured so far, can then be used directly as a prosthesis shaft or can be further processed into a blank for a prosthesis shaft, for example by thermoforming and / or by attaching a screw connection to a further prosthesis part, etc.

[0244] Figure 5a A schematic diagram shows a knitted fabric 110 according to the invention (optionally a "sandwich structure" of a tube, sock or stocking, hereinafter referred to as knitted fabric 110) in which or on which, in one embodiment, a material according to the invention, optionally a set of materials according to the invention, is inserted or applied.

[0245] A cross section through the braid 110 is shown, inside which the limb stump KS is located in the pressure chamber DK during the fitting of the prosthesis and outside of which the fluid F acts on the braid 110 , separated at least by the membrane 5 .

[0246] exist Figure 5aIn the example of the present invention, the braid 110 is multi-layered, i.e., comprises different braided or fabric layers 111, 113, 115, 117, which are shown as circular layers (or plies) with different diameters for the sake of clarity. This representation is purely exemplary and should not be understood as limiting. The present invention also covers other shapes / profiles of the braid.

[0247] In some embodiments, two or more braided layers 111 , 113 , 115 , 117 may include the same shape / contour, the same size, and / or the same orientation.

[0248] exist Figure 5a In the example of , the braid comprises four braided layers 111, 113, 115, 117 and a fabric layer, which may be, for example, a fabric layer. Pad 119. The number and configuration of layers or braids are purely exemplary and should not be construed as limiting.

[0249] In some embodiments, one or more layers, for example, the woven layers 111 , 113 , 115 , 117 , include or consist of glass fibers.

[0250] Providing multiple layers overlapping each other in the radial direction R contributes to the fact that the intersections within the individual woven layers 111, 113, 115, 117, for example if they have a mesh form, tend not to overlap each other throughout the braid 110, or if they do, this contributes to the fact that the resulting accumulation of material in the radial direction does not create avoidable pressure that impairs the patient's future wearing comfort or creates pressure points during the process.

[0251] In some embodiments, the plurality of layers comprises or consists of a mesh or woven portion.

[0252] Preferably, optionally the pad 119 forms the innermost layer and is preferably made of or comprises an elastic fabric. Preferably, optionally the pad 119 is a white fabric in order to increase the light output. Preferably, in these embodiments, this pad 119 or this layer which ultimately faces the patient's limb stump KS is made of a very fine mesh or fine-pored material in order to advantageously achieve a smoothest possible inner surface of the prosthesis shaft manufactured according to the invention. This can help to achieve a later, preferably step-free inner side of the prosthesis shaft, which is required for applying the vacuum and thus achieve a good fit of the prosthesis shaft on the limb stump KS.

[0253] In some embodiments, the liner 119 may be wet, such as soaked with water.

[0254] exist Figure 5aIn the example of, the liner 119 optionally forms the innermost layer of the braid 110. Its outer side is exemplarily designed to be light-reflective or reflective, for example, by a mirror film 120 (see Figure 5b ).

[0255] Figure 5b The schematic diagram shows the side view of Figure 5a The braid 110 is again shown in cross-section, where only one longitudinal segment is shown, rather than the entire length of the braid 110. The entire braid 110 will extend upward and downward beyond Figure 5b The range shown in , that is, along the longitudinal direction L.

[0256] Reference About Figure 5a description to avoid duplication.

[0257] You can see Figure 5a An optional mirror film 120, not shown, is preferably between the outermost layer of the woven layers 111, 113, 115, 117 and the pad 119. The mirror film 120 can in particular increase, for example, brightness. And improve the penetration of the optional multiple deformable woven layers 111, 113, 115, 117 that can be cured by an energy source. This can also help to shorten the curing time of the material according to the invention.

[0258] In some embodiments, Figure 5a and Figure 5b As shown, the material according to the present invention that can be incorporated into or applied to the braid 110 is or includes a light-curable resin, preferably an acrylic resin. It can be or include a photopolymer. It can contain reactive additives and / or odorants.

[0259] Figure 6a and Figure 6b A possible principle of the braid 110 is shown in schematic form, or in another embodiment only individual layers of the braid 110 are shown.

[0260] Here, the braided fabric 110 is shown by an elongated or long stretched mesh structure portion or braided structure portion 210 (hereinafter referred to as portion 210), which is intended to embody or represent fibers or threads or strips. The elongated portion 210 is connected to at least one other elongated portion 210, for example to at least one adjacent elongated portion 210, in particular in a form-fitting and / or force-fitting manner, at one or more locations, such as end portions and / or central portions (herein referred to as intersections or knots 220).

[0261] However, between such intersections or junctions 220, the portions 210 connected therein are preferably spaced apart from adjacent portions 210, as depicted by the spaces Z in FIGS. 2 and 3. Figure 6a and 6bAs shown, a mesh structure with each space Z enclosed is finally obtained.

[0262] exist Figure 6a and 6b In the example of FIG. 2 , a junction 220 is preferably a junction between fibers and / or threads, represented by a portion 210 , where a portion 210 may be connected to one, two, or more other portions 210 .

[0263] Figure 6a and Figure 6b A comparison of 210 illustrates the alternative scissor-like or diamond-like deformability of the configuration of the portion 210 through the intersection point 220 , wherein relative motion between two portions contacting each other at a particular intersection point 220 is not necessary and therefore may or may not be permitted.

[0264] The fact that multiple layers or braids 111, 113, 115, 117 of such a braid 110 are provided, which overlap one another in the radial direction, facilitates the intersection points 220 (e.g., meshes). It is unlikely that the meshes of these layers overlap one another, or only in rare cases, or if it does, the resulting accumulation of material in the radial direction does not cause or lead to an increase or cause of avoidable pressure points that would impair, for the patient, the wearing comfort of the prosthetic shaft produced according to the invention or the process of producing said prosthetic shaft.

[0265] Figure 7a A greatly simplified version of another embodiment and only a portion of a braid 110 is schematically shown.

[0266] The braid 110 is shown in a cutaway state, wherein the braid 110 does not assume the shape in which it is used in the device 100 or set according to the present invention. It can be formed into a braid by connecting its left and right edges together and cutting or trimming it if necessary. Figure 5a The shapes shown by way of example or at least outlined in FIG.

[0267] exist Figure 7a In the embodiment, it is assumed that the braid 110 includes only one braid layer, as disclosed herein, for example, Figure 5a 111, 113, 115 or 117. However, Figure 7a The content shown in can also be applied or extended to the braided material 110 having more than one braided layer. For the sake of clarity only, Figure 7a Only one braided layer is shown.

[0268] Purely exemplary, two pairs of longitudinal fibers and transverse fibers or longitudinal or transverse bands are shown, respectively, as 55a and 57a and 55b and 57b, which are only exemplarily perpendicular to each other. The above description of part 210 does not contradict the contents disclosed herein about fibers or bands 55a or 57a and 55b and 57b, but may also be applied to the latter, i.e. fibers or bands 55a or 57a and 55b or 57b.

[0269] The longitudinal fibers 55a may be selectively stretched and thus selectively not allowed to extend in the longitudinal direction. any further stretching.

[0270] In contrast, the transverse fibers 57a considered in conjunction therewith can allow the braid 110 to stretch in the transverse direction Q, due to their looped or twisted or corrugated course or material in the matrix of the braid 110, which in addition to the fibers can also be soaked with the material according to the invention or can have absorbed this material. Therefore, the longitudinal fibers 55a and the transverse fibers 57a differ from each other in their ability to stretch or expand or extend under tensile loads, such as tensile loads. Functionally; optionally, they also differ in the material from which they are made and / or in their cross-section.

[0271] In the two exemplary considered fibers 55b and 57b belonging to each other, the same or similar effects can be achieved differently. The longitudinal fibers 55b are thicker and therefore do not stretch, or stretch less than the associated thinner transverse fibers 57b.

[0272] It goes without saying that the braid 110 may include more fibers than those shown here. It also goes without saying that the braid 110 may preferably include longitudinal fibers and transverse fibers 55a and 57a or longitudinal fibers and transverse fibers 55b and 57b, and therefore preferably does not necessarily include the two pairs of longitudinal or transverse fibers discussed herein.

[0273] Figure 7b and Figure 7c A braided fabric 110 is shown having one or more braided layers having longitudinal fibers 55 and transverse fibers 57, similar to Figure 7a , in which transverse fibers 57 connect longitudinal fibers 55.

[0274] The longitudinal fibers 55 extend straight, whereas the transverse fibers 57 extend between adjacent (or non-adjacent) longitudinal fibers 55 , having both transverse and longitudinal extensions.

[0275] Thus, the transverse fibers 57 are, for example, Figure 7b and Figure 7c They can present a single zigzag route, such as Figure 7bAs shown in , the double zigzag route, such as Figure 7c or multiple zigzag routes (as not shown), or otherwise circular or meandering.

[0276] Of course, the transverse fibers 57 and the longitudinal fibers 55 may have the same structure and / or the same thickness. Their configuration relative to the longitudinal direction makes the woven fabric 110 stretchable or extensible (or more stretchable or more extensible) (in the transverse direction Q) or (in the longitudinal direction Q) ) is either non-stretchable or extensible (or less stretchable or less extensible).

[0277] If the longitudinal fibers 55- Figure 1 Unlike that shown in FIG. 2 , the longitudinal fibers 55 may be longitudinal fibers 55. Figure 7b and 7c As shown, it is not allowed to extend in a straight line, but it is allowed to extend in the longitudinal direction. A shortening of the braid 110 in the longitudinal direction can be advantageous by extending it in a more or less pronounced zigzag pattern around a straight line. This can be achieved if necessary. Thus, the possible shortening can be "set" or limited in advance by coordinating the dimensions and measurements of the zigzag pattern of the longitudinal fibers 55 and / or the transverse fibers 57. The shortening can be advantageous in terms of an undesired elongation of the braid 110. This can be counteracted in a structurally simple and effective manner.

[0278] Figure 8a A body 300 in a first embodiment is schematically and simplified, which can be a component of a set or kit according to the invention and can be used in a method according to the invention. Such a body 300 can be made of silicone or other suitable materials, for example.

[0279] exist Figure 8a In the example of FIG. 3 , the form 300 is applied to the patient's limb stump KS from behind and optionally fastened thereto, for example by means of a film.

[0280] Its design can be used to widen a prosthetic shaft to be created posteriorly or dorsally, for example, similar to the upper edge of a calyx, in order to subsequently relieve the flexor tendons of the patient wearing the prosthetic shaft. Figure 8a It is represented by 305.

[0281] like Figure 8b As shown, the arrow here points from the posterior or dorsal side to the anterior or ventral side.

[0282] Figure 8b Schematic simplified view of the Figure 8a Attached or flat body Figure 8cA schematically simplified diagram shows a knee joint of a patient in another embodiment, wherein a body 301 is attached proximally, which body can be a component of a set or kit according to the invention and can be used in the method according to the invention. Such a body 301 can be made of or include plastic, reinforced or carbon reinforced plastic or other suitable materials, in particular as disclosed herein. A cross section of a limb stump KS of 300 is shown.

[0283] exist Figure 8c In the example of , the body 300 can optionally have the shape of a bracket, which is attached to the patient's knee joint from the front proximal end. The body 301 is used to narrow the limb residual limb KS above the knee joint, or to compress the soft part during the production of the prosthesis shaft or the plaster model to increase the wearing comfort of the patient of the prosthesis manufactured based on the prosthesis. The limb residual limb KS compressed in this way is the same regardless of whether the prosthesis is made of curable material or traditional material, i.e., for example, made of curable material. After plastering. This compression can be, for example, between 6 mm and 7 mm on each side (outside, inside).

[0284] Figure 8d The schematic diagram shows Figure 8c A top view of body 301.

[0285] The body 300, 301 can be placed on the limb stump KS from the front or ventral side or from the back or dorsal side. Figure 1 and the embodiment of FIG. 2 Figures 8a to 8d It is purely exemplary and should not be construed as limiting.

[0286] Fig. 9 An exemplary sequence of the method according to the invention for applying a deformable material that can be cured by an energy source to a limb stump KS or for producing a prosthetic shaft or a part thereof for a limb stump KS of a patient in a first exemplary embodiment is shown schematically and in simplified form.

[0287] Reference is made to the component numbers with respect to the preceding figures.

[0288] Method step M1 represents the provision of a set according to the invention.

[0289] Filling the fluid chamber or pressure chamber DK of the pressure vessel 1 with the fluid disclosed herein is represented by method step M2. Alternatively, method step M2 represents providing a fluid chamber or pressure chamber DK filled in this way.

[0290] In method step M3, the insertion of the limb stump KS into the membrane 5 is shown. This insertion takes place so that the limb stump KS is surrounded by the membrane 5 around its entire circumference at least in its section and so that the deformable material that can be cured by the energy source is present at least in the section between the limb stump KS and the membrane 5. Thus, the limb stump KS can optionally be at least partially surrounded or wrapped with a wet plaster bandage. Method step M3 can also optionally include placing the body 300, 301 on the patient's skin.

[0291] Optionally, curing or partially curing the material by using an energy source inside the pressure vessel 1 is represented in method step M4 .

[0292] In method step M5 , the residual limb KS is optionally subsequently removed from the pressure vessel 1 , preferably together with the surrounding material, which optionally is completely or partially solidified, or is removed from the pressure vessel 1 .

[0293] The optional or further curing or partial curing of the material using an energy source external to the pressure vessel 1 is represented in method step M6. This step can be performed in addition to or as an alternative to method step M4.

[0294] In method step M7 or based thereon, a complete prosthesis is optionally created based on the prosthesis shaft thus obtained, or individual parts thereof based on the solidified material, without a previous positive impression of the limb stump KS being required.

[0295] Although the present description focuses on the creation of prosthetic shafts based on curable materials, the invention is not limited thereto. Many combinations of features and embodiments are also in accordance with the invention, even though they are based on conventional (negative) plaster impressions. For example, the use of the forms described herein can therefore be claimed as an invention. Their use is not limited to the simultaneous use of curable materials.

[0296] Main component markings

[0297] 100 devices

[0298] 1. Pressure vessel

[0299] 2First end side

[0300] 3 Wall

[0301] 4 The second end side can be optionally closed or sealed with the bottom area

[0302] 4a Base area

[0303] 5. Film

[0304] 7 Upper edge

[0305] 5a Proximal or first membrane portion; reinforcing portion of the membrane

[0306] 5b Distal or second membrane portion

[0307] 9 Insert opening

[0308] 19' exit, entrance

[0309] 53 Connectors

[0310] 55 longitudinal fibers

[0311] 55a Longitudinal fibers

[0312] 55b Longitudinal fibers

[0313] 57 Cross Fiber

[0314] 57a Cross Fiber

[0315] 57b Cross Fiber

[0316] 58 The center or middle area or portion of a membrane

[0317] 81 Floating membrane

[0318] 83 Contact surface

[0319] 85 Transition

[0320] 91 Remote Connector

[0321] 95 UV light source

[0322] 97 Ultraviolet radiation

[0323] 99 Vector Tower

[0324] 99' hole; translucent part

[0325] 110 Braiding; tube; socks; stockings

[0326] 111 braided layer; fabric layer

[0327] 113 woven layer; fabric layer

[0328] 115 braided layer; fabric layer

[0329] 117 woven layer; fabric layer

[0330] 119 Pad

[0331] 120 Mirror Mask

[0332] 210 mesh structure part; woven structure cross section; part 220 intersection; knot

[0333] 300 Shape

[0334] 301 Shape

[0335] 305 Extension part (301) A connector of prosthetic shaft

[0336] Pressure vessel exterior

[0337] B distance

[0338] DK Pressure Vessel Pressure Chamber

[0339] IInterior of the pressure vessel

[0340] FLiquid or liquid

[0341] H Pressure chamber height

[0342] KS Limb Remnants

[0343] L vertical

[0344] The vertical direction of the braid

[0345] M1 bis M7 method steps

[0346] QWeave transverse direction

[0347] R Radial

Claims

1. A set for taking an impression of a limb stump (KS), in particular a lower leg stump, or for producing a prosthetic shaft or a part thereof, wherein: The set includes or consists of: A medical device (100), wherein the device (100) comprises at least: A pressure vessel (1) having a fluid chamber or pressure chamber (DK) for receiving or storing a fluid (F), in particular a fluid under pressure, wherein the pressure vessel (1) comprises a wall (3) made of a first material, wherein the wall (3) limits an interior (I) of the pressure vessel (1) against an exterior The pressure container (1) comprises an insertion opening (9) for inserting the severed limb (KS) into the interior (I) of the pressure container (1); a fluid-tight membrane (5) made of at least a second material, the membrane (5) being configured to form or delimit a fluid chamber or pressure chamber (DK); at least one energy source for curing or partially curing a deformable material in order to obtain or realize an impression of a limb stump (KS) or to obtain or realize a prosthetic stump; and / or A deformable material that can be cured by an energy source, the deformable material being other than plaster or consisting solely of plaster.

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

3. The set according to claim 2, characterized in that it comprises at least 5, preferably at least 6, 8 or more UV radiation sources (95).

4. The set according to claim 2 or 3, characterized in that: The UV radiation sources (95) emit light with a wavelength of 405 nanometers, preferably emit radiation with a wavelength between 395 nanometers and 415 nanometers, particularly preferably emit radiation with a wavelength between 400 nanometers and 410 nanometers, or they emit only such radiation.

5. A set as claimed in any one of the preceding claims, characterised in that The at least one energy source for curing or partial curing is connected to a portion of the pressure vessel (1).

6. A set as claimed in any one of the preceding claims, characterised in that The at least one energy source for curing or partial curing is not connected to the medical device (100), in particular not connected to a part of the pressure vessel (1).

7. A set as claimed in any one of the preceding claims, characterised in that The at least one energy source is arranged outside the pressure chamber (DK), the pressure container (1) or the medical device (100).

8. A set as claimed in any one of the preceding claims, characterised in that 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 or processed in another way.

9. A set as claimed in any one of the preceding claims, characterised in that The medical device (100) or a part thereof, preferably a wall (3) thereof, comprises at least one portion which is transparent to radiation, in particular optical radiation or UV light radiation, in particular in the region of the wall (3) of the pressure vessel (1).

10. The set according to claim 9, characterized in that The part of the medical device (100), preferably the wall (3), comprises or consists of UV-resistant acrylic glass, such as Plexiglas.

11. A set as claimed in any one of the preceding claims, characterised in that The material is or includes a light-curable resin, preferably an acrylic resin 12. A set as claimed in any one of the preceding claims, characterised in that The material is or includes a photopolymer 13. A set as claimed in any one of the preceding claims, characterised in that The material comprises an odorant.

14. A set as claimed in any one of the preceding claims, characterised in that The material contains a reactive additive 15. A set as claimed in any one of the preceding claims, characterised in that The materials are applied to and / or incorporated into a knit, mesh, tube, sock or stocking, respectively.

16. The set according to claim 15, characterized in that The knitted fabric, the tube, the sock and / or the stocking are multi-layered.

17. The set according to claim 15 or 16, characterized in that The knitted fabric, the mesh structure, the tube, the sock and / or the stocking comprises several layers, preferably at least 4 layers, preferably at least 5 or 6 layers.

18. The set according to claim 16 or 17, characterized in that The plurality of layers comprises or consists of glass fibres and / or non-elastic fabrics or non-elastic materials.

19. A set according to claim 16, 17 or 18, characterized in that A plurality of the layers include or consist of a mesh portion or a woven portion.

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

21. A set as claimed in any one of the preceding claims, characterised in that A liner is included, which is preferably designed to be light-reflective or reflective on its outer side, such as using a mirror film on the outer side.

22. A set according to any one of claims 16 to 21, characterised in that The innermost layer is designed to be light-reflective or reflective on its outer side, for example by using a mirror film on the outer side.

23. A set as claimed in any one of the preceding claims, characterised in that The deformable material is connected to a connection, in particular a screw connection, for the distal prosthetic component before curing, or is segmentally surrounded or segmentally embedded.

24. A set as claimed in any one of the preceding claims, characterised in that A pad comprising a light source or providing for directing or guiding light into the pad 25. A set as claimed in any one of the preceding claims, characterised in that The medical device (100) comprises: an outlet (19) which is a fluid connection between the fluid chamber or pressure chamber (DK) and the exterior (Λ) of the pressure vessel (1); and A valve, a locking device or a plug valve is used to open and close the outlet (19) or fluid communication.

26. A set as claimed in any one of the preceding claims, characterised in that The membrane (5) of the medical device (100) is made of or includes a material having different elasticity or stretchability in a first direction of the material than in a second direction of the material. The second direction may be perpendicular to the first direction.

27. A set as claimed in any one of the preceding claims, characterised in that The membrane (5) of the medical device (100) is made of or comprises a material comprising fibers (55a, 57a; 55b, 57b) along a first direction and / or in a second direction of the material, the fibers are preferably embedded in a matrix or are preferably connected to a matrix in another way.

28. A set as claimed in any one of the preceding claims, characterised in that The membrane (5) of the medical device (100) is non-stretchable or inelastic in its first direction and / or its second direction.

29. A set as claimed in any one of the preceding claims, characterised in that The membrane (5) of the medical device (100) is at least partially transparent to radiation of the energy source, in particular light, preferably UV light.

30. A set as claimed in any one of the preceding claims, characterised in that There is a control device configured to limit the energy source or its power or output so that the temperature of the interior of the knitted fabric, the tube, the sock or stocking does not exceed 40°C.

31. A method for attaching a material that can be deformed and solidified by an energy source to a limb stump (KS), or for producing a prosthetic shaft or part thereof for a limb stump (KS) of a patient, characterized in that The method comprises the steps of: Providing a kit according to any one of claims 1 to 30; Filling a fluid chamber or pressure chamber (DK) of a pressure vessel (1) with a fluid, in particular a liquid (F), or changing the liquid level in the fluid chamber or pressure chamber (DK) so that the membrane (5) is covered with the liquid (F) at least in its parts around the entire circumference of these parts, or so that the membrane (5) is bent through the insertion opening (9) of the pressure vessel and outwardly enters the outside of the pressure vessel (1) Alternatively, a fluid chamber or a pressure chamber (DK) can be filled in this way.

32. The method of claim 31, wherein: The following steps are also included: The limb stump (KS) is inserted into the membrane (5) so that the limb stump (KS) is covered or surrounded or enclosed by the membrane (5) around its entire circumference at least in part, and so that a deformable material that can be solidified by an energy source is present at least in the part between the stump (KS) and the membrane (5).

33. The method according to the preceding claim, characterized in that A body (300, 301) is arranged at least in sections between the membrane (5) and the limb stump (KS).

34. The method according to any one of the preceding claims 31 to 33, characterized in that The following steps are also included: removing the limb stump (KS), preferably together with the surrounding material, from the pressure vessel (1); and An energy source external to the pressure vessel (1) is used to cure or partially cure the material.

35. The method according to any one of the preceding claims 31 to 34, characterized in that The following steps are also included: using an energy source within the pressure vessel (1) to cure or partially cure the material; and The limb stump (KS) is removed from the pressure vessel (1), preferably together with the surrounding fully or partially solidified material.

36. A method according to any one of the preceding claims 31 to 35, characterised in that The following steps are also included: Energy is introduced, for example as light, into the pad or along the pad material.

37. The method according to any one of the preceding claims 31 to 36, characterized in that The following steps are also included: The creation of a prosthetic shaft, a part of a prosthetic shaft or a complete prosthesis based on the solidified material without the need for a previous positive impression of the limb stump (KS).

38. A prosthetic shaft or part thereof manufactured by means of a set according to any one of claims 1 to 30, or by a method according to any one of claims 31 to 37.

39. A film (5) or a liner for use in a kit 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 film (5) or the liner is transparent and / or comprises or is connected to a light guide and / or a light source (95).

40. A material that can be deformed and solidified by energy.

41. The material according to claim 40, characterized in that The material is or includes a photocurable resin, preferably an acrylic resin.

42. The material according to any one of claims 40 to 41, characterized in that The material is or comprises a photopolymer.

43. The material according to any one of claims 40 to 42, characterized in that The material comprises an odorant.

44. The material according to any one of claims 40 to 43, characterized in that The material comprises a reactive additive.

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

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

47. The material according to any one of claims 45 to 46, characterized in that The knitted fabric, the tube, the sock and / or the stocking comprises several layers, preferably at least 4 layers, preferably at least 5 or 6 layers.

48. The material according to claim 47, characterized in that A plurality of said layers comprises or consists of glass fibers.

49. The material according to claim 48, characterized in that The glass fiber is connected or connectable to an energy source, for example a light source, via a connector, a connection or the like, for guiding light, in particular UV light.

50. The material of claim 49, wherein The sheath of the glass fiber at least partially includes holes, windows, or the like to allow light, particularly UV light, to be emitted from the fiber to facilitate curing of the material.

51. The material according to any one of claims 46 to 50, characterized in that A plurality of said layers comprises or consists of a mesh part or a woven part.

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

53. A kit comprising: A material according to any one of claims 40 to 52, and Bags in which materials can be or have been stored.

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

55. A kit according to any one of claims 53 to 54, characterised in that Included are a plurality of such braids, tubes, meshes, socks or stockings disposed in one or more bags.

56. The kit of claim 55, wherein: At least two or more of the braids, tubes, meshes, socks or stockings differ from one another to at least one respective degree, such as at the same height, the same distance from the distal end, etc.

57. A kit according to any one of claims 55 to 56, characterised in that At least two or more of the braids, tubes, socks or stockings have the same length in a distal-proximal orientation.

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