DE102022105269A1 - Set with a device for creating a prosthetic socket from UV light-curing resin material and method - Google Patents

Abstract

The present invention relates to a set for use in making an impression of a limb stump (KS), in particular a lower leg stump, or a prosthesis socket or a part thereof. The set has or consists of a medical device (100), at least one energy source and a deformable material that can be hardened by means of an energy source. The medical device (100) has at least one pressure vessel (1) with a fluid chamber or a pressure chamber (DK) for receiving or storing a fluid (F), the pressure vessel (1) in turn having a wall (3) made of a first material and a fluid-tight membrane (5) made of at least one second material, furthermore an insertion opening (9) for inserting the limb stump (KS) into the interior (I) of the pressure vessel (1). The membrane (5) is arranged to form or delimit the fluid chamber or the pressure chamber (DK). The energy source is used to cure or partially cure the deformable material to obtain an impression of the residual limb (KS) or to create a prosthetic socket.

Description

The present invention relates to a set according to claim 1, also a method according to claim 14 and a prosthesis socket, or a part thereof, according to claim 21 and a membrane according to claim 22, or according to the preambles or generic terms of these claims.

Leg amputees can regain mobility with leg prostheses. Modern leg prostheses include various modules, one of which is the prosthesis socket.

The present invention relates to the technical field of producing a prosthesis socket of a prosthesis or a prosthesis, preferably for the lower extremities, ie for a leg prosthesis, in particular a lower leg prosthesis.

An object of the present invention can be to propose a set with a medical device for use in making an impression for a prosthetic socket or in making a prosthetic socket, or at least for an inner or outer socket thereof, in particular for the lower extremity.

The object according to the invention can be achieved by means of a set with the features of claim 1. It can also be solved by means of a method with the features of claim 14 and by means of a prosthesis socket with the features of claim 21 and by means of a membrane with the features of claim 22.

According to the invention, a set is thus proposed for use in making an impression of a limb stump, in particular a lower leg stump, or for use in making a prosthesis socket or a part thereof. In this case, the set has a medical device (hereinafter also briefly: device).

The device can be used, for example, as a basis for the manufacture of a lower leg prosthesis socket, with the patient only preferably standing.

The device has a fluid container or pressure container with precisely or at least one pressure chamber or precisely or at least one fluid chamber. This can absorb or store an optionally pressurized fluid. The pressure is above atmospheric pressure. The fluid is a gas or a liquid, preferably air or water, since the latter are both cheap and readily available.

The pressure vessel has a wall which is made from at least or precisely one first material or has at least one first material.

The wall of the pressure vessel delimits its interior. According to the invention, the interior of the pressure vessel is understood to mean that space or that volume which is predetermined by the geometry of the pressure vessel or encompassed or circumscribed by an outer wall of the pressure vessel. If the pressure vessel is cylindrical, for example, then the interior of the pressure vessel is the space delimited by the cylindrical lateral surface and the two end faces or end planes. In another example, if the pressure vessel is rectangular, the interior space is defined by the result of multiplying the height, width and depth of the rectangle. When determining the interior, it does not matter whether the space corresponding to the interior is fluid-tight or not. The interior does not describe a fluid-tight sealed space but a volume circumscribed by the wall. The space which is not part of the interior of the pressure vessel is referred to herein as its exterior.

The pressure vessel has an insertion opening through which the limb stump (in this context this can always mean the distal end of the stump instead of the entire stump) can be inserted into the interior of the pressure vessel. The insertion opening can be, for example, an open end face or end plane, a through opening in the wall or an opening which breaks through or interrupts the wall. In the area of the insertion opening, the interior is therefore not separated from the exterior of the pressure vessel by a section of the wall. The insertion opening can be in an entry opening or in an insertion plane through which the residual limb is introduced into the interior of the pressure vessel.

Furthermore, the pressure vessel has at least one or precisely one, preferably fluid-tight, membrane. Alternatively, the pressure vessel does not have such a membrane, which is described further below, but only correspondingly suitable and/or provided receiving devices (such as the connector described below as optional) for receiving the membrane on the pressure vessel.

The membrane is made of a second material or has such a material. The first and the second material differ from each other.

At least a portion of the membrane, which in an upper and / or a proximal Area is and / or which faces the insertion opening of the pressure vessel is preferably connected to at least one connector, preferably detachable. The membrane is attached to the pressure vessel, preferably in a detachable manner, by means of this at least one connector. The connection can be ribbon-like, rope-like, flexible and/or pliable.

The set according to the invention further comprises at least one energy source for curing or partially curing a deformable material in order to produce an impression of the residual limb or a prosthetic socket.

Furthermore, the set according to the invention optionally comprises a material that is initially deformable but can be hardened by means of an energy source, which after hardening is preferably no longer deformable, in particular not chip-free, permanent or permanent and/or not deformable without the use of tools, flexible, fluid, elastic , bendable etc. The material is preferably not gypsum, does not include gypsum, or preferably does not consist solely of gypsum, and/or supporting material (cloth, netting, gauze, etc.) required or commonly used to hold wet plaster.

It is encompassed by the present invention that the set consists of the medical device, the energy source and the material.

The medical device can be provided for use in making a negative impression of a limb stump, in particular a lower leg stump, the device having a fluid container (can be a pressure container) for a liquid, such as water, it being possible for the following to apply: The fluid container has an im and a lower, or second, face during use. In the area of the second end face, the fluid container can be sealed in a fluid-tight manner, for example by means of a base surface. The device includes a sheet or membrane for receiving a portion of a limb residual limb. The membrane is connected to the container in a fluid-tight manner and/or closes it at least at the top or at least on the first end face, at least in sections, in a fluid-tight manner. The fluid container can optionally have a pressure chamber. The fluid container optionally has at least one outlet for the fluid, which is optionally provided with a valve or a stopcock for opening and closing the outlet. The membrane is preferably sac-like (that is, with a dead end like a sac, as opposed to a tube open at the top and bottom). At least one upper and/or proximal section and/or a section located in the area facing the insertion opening of the pressure vessel is preferably connected to or with a section of a wall of the fluid container, for example a bottom surface or side surface thereof, by means of at least one connector detachable, directly or indirectly attached. The membrane is preferably made of a material or has such a material that has no (or only a slight) elasticity or preferably no (or a only low) extensibility. Instead of having the aforementioned membrane and/or connector, the device may be designed or configured to be connected to a membrane and/or connector. Connection devices suitable for this purpose, for example on a floor surface or side wall, can be provided.

According to the invention, a method is proposed for fitting a deformable material, which can be cured by an energy source, which can be a radiation source, to a limb stump or for creating a prosthetic socket (or a part thereof) for a limb stump of a patient.

Here, the method includes the step of providing a set according to the invention.

Furthermore, filling the fluid chamber or pressure chamber of the pressure vessel with a fluid, in particular a liquid, is included in the method according to the invention if the pressure vessel of the medical device is not already filled with fluid, preferably a liquid. Alternatively or additionally, a liquid level within the fluid chamber or pressure chamber can be changed in such a way that the membrane is covered by the liquid at least in sections of it around the entire circumference of these sections, or in such a way that the membrane extends beyond the insertion opening of the pressure vessel into arching the outside of the pressure vessel. As a further alternative, provision is made for a fluid chamber or pressure chamber that is suitably filled in this way or in some other way.

According to the invention, a prosthesis socket or a part thereof, for example an outer socket or an inner socket, is also proposed, which was produced in a device of the set according to the invention or according to a method according to the invention.

According to the invention, there is also a membrane for use in a set according to the invention and/or in a method according to the invention proposed, wherein the membrane is transparent and/or comprises or is connected to a radiation or light source. A use of such a membrane as disclosed herein for the membrane is also proposed.

Embodiments according to the invention of each of the aforementioned objects can have one or more of the features mentioned below in any combination, provided that a specific combination is not evidently technically impossible for a person skilled in the art. The subject matter of the subclaims also each specify embodiments according to the invention.

In all of the above and/or following statements, the use of the expression “can be” or “can have” etc. is to be understood as synonymous with “is preferably” or “has preferably” etc. and is intended to explain embodiments according to the invention.

Whenever numerical words are mentioned herein, the person skilled in the art understands them as indicating a numerical lower limit. Provided that this does not lead to a discernible contradiction for the person skilled in the art, the person skilled in the art always reads “at least one” or “at least one” when specifying “a” or “an”. This understanding is also contemplated by the present invention, as is the interpretation that a numeral such as "a" may alternatively be meant to mean "exactly one" wherever this is evidently technically possible for those skilled in the art. Both are encompassed by the present invention and apply to all numerals used herein.

Whenever spatial references such as "above", "below", "upper" or "lower" are mentioned, the person skilled in the art understands these in case of doubt as a spatial indication with reference to the orientation in the figures attached here and/or the arrangement of the set according to the invention with its device(s) in their intended use.

If it is disclosed herein that the object according to the invention has one or more features in a specific embodiment, it is also disclosed herein that the object according to the invention expressly does not have this or these features in other embodiments that are also according to the invention, e.g. B. in the sense of a disclaimer. For each embodiment mentioned herein, the contrary embodiment, for example formulated as a negation, is also disclosed.

The membrane can optionally have multiple segments or sections. For example, a distal section, in particular a section on which low forces are exerted, in particular lower forces than other sections of the membrane, can have smaller wall thicknesses than the other section or sections. A section of the membrane on which lower forces act can have a different material, for example a softer material, than other sections of the membrane. The forces can be tensile forces and/or compressive forces. A further, proximal section of the membrane can be made from a second material or has such a material, with the proximal section being able to have a greater wall thickness and/or other material properties than the distal section. In particular, the proximal section can be made of a composite material or have such a material. The distal section can be coated on one or both sides.

Several sections of the membrane can be connected to one another in a material-locking or material-locking manner. Alternatively or additionally, the sections of the membrane can be connected mechanically, for example by means of adapters, clamps, clamping rings or the like.

In certain exemplary embodiments according to the invention, the pressure chamber is a closed and/or lockable space in which the fluid can be subjected to a pressure above atmospheric pressure (atmosphere for short) without being able to escape from this space.

In some exemplary embodiments according to the invention, the membrane is arranged to form the pressure chamber or, alternatively, to delimit it, for example by being part, in particular elastic or unidirectionally elastic, of the wall or delimitation of the pressure chamber.

In certain exemplary embodiments according to the invention, the membrane serves to, on its own (e.g. in the form of a balloon) or alternatively together with sections of the wall, a fluid-tight sealed fluid chamber of the pressure vessel that is at least partially or completely inside the pressure vessel to build. Since it can receive and/or hold fluid under a pressure which is above atmospheric pressure, this fluid chamber is referred to herein as a pressure chamber.

The terms "fluid chamber" and "pressure chamber" are in certain exemplary embodiments according to the invention and/or in such embodiments in which those skilled in the art from a technical point of view there is nothing to be said against it, interchangeable. What is said herein about a "pressure chamber" may also apply to a "fluid chamber".

In some exemplary embodiments according to the invention, the pressure chamber is located inside the pressure vessel when the pressure prevailing in the pressure chamber does not exceed a certain pressure. Deviating from this, in certain exemplary embodiments according to the invention, the pressure chamber also extends to the outside of the pressure vessel if the pressure prevailing in the pressure chamber acts on the membrane in such a way that the latter, for example, bulges outwards through the insertion opening, i.e. into the outside of the pressure vessel . The pressure chamber can thus have a variable volume which depends on the pressure prevailing in the pressure chamber. The latter does not apply to the constant interior or internal volume of the pressure vessel either.

In some exemplary embodiments according to the invention, a fluid can be kept under pressure in the pressure chamber, which is above the atmosphere, regardless of the insertion opening breaking through the wall.

In certain exemplary embodiments of the present invention, the pressure chamber is for receiving or supporting the distal end of the patient's residual limb as it is inserted into the interior of the pressure vessel. Due to the fluid contained in the pressure chamber, the membrane nestles laterally or circumferentially against the distal end of the limb stump or against the entire limb stump. In this way it may be possible to apply preferably unchanged or the same pressure to the limb stump in the area of the entire layer of material wrapped around it, plaster bandage etc. through the membrane, based on a unit area. The latter can represent an advantageous contribution of the present invention, since the uniform application of pressure can already lead to a uniform modeling of the deformable material or the moist plaster bandage. The contact of the membrane under the fluid stored in the pressure chamber can advantageously make modeling by hand unnecessary or significantly reduce the effort for this.

In some exemplary embodiments according to the invention, the pressure chamber is a fluid-tight, closed space which is formed or delimited completely, or among other things, by the wall of the pressure vessel and the membrane. In some exemplary embodiments according to the invention, the term "pressure chamber" can be replaced by the above definition.

In some exemplary embodiments of the present invention, the pressure vessel is that vessel or space in which the pressure chamber is located.

In some exemplary embodiments of the present invention, the pressure vessel is a water vessel.

In some exemplary embodiments according to the invention, the term “pressure vessel” can be replaced by the term “fluid vessel” or “water vessel”.

In certain exemplary embodiments of the present invention, the pressure vessel is cylindrical in shape.

In some exemplary embodiments according to the invention, the pressure chamber is designed and/or arranged in such a way that the pressure prevailing in it depends, among other things or exclusively, on the insertion depth of the limb stump into the interior of the pressure vessel, at least when the device is used as intended and when the inlet is closed - and outlets, if any.

In certain exemplary embodiments according to the invention, the membrane, for example a second section of the membrane, is in particular a section with increased strength (for example by means of an increased wall thickness and/or other material properties through composite materials, coatings or the like) compared to the one or more other sections of the membrane , arranged in the area of the insertion opening and optionally connected there directly or indirectly to the wall in a detachable or non-detachable manner, preferably in a fluid-tight manner. It closes the insertion opening, preferably similar to a cover, provided the pressure in the pressure chamber does not deviate significantly from atmospheric pressure.

In some exemplary embodiments according to the invention, the membrane is arranged in order to prevent a fluid or material exchange inside the pressure vessel in its axial direction.

In certain exemplary embodiments according to the invention, the membrane is always arranged in a single layer in the axial and/or radial direction, in others it is not.

In some exemplary embodiments of the present invention, the membrane is at a first end face of the pressure vessel connected directly or indirectly to this, but not also on a second end face opposite the first, at least not without a connector arranged between the membrane and the end face, preferably of at least 5 cm in length.

In certain exemplary embodiments of the present invention, the membrane is flat or balloon-like (i.e., open at one end) rather than tubular (i.e., open at both ends).

In some exemplary embodiments according to the invention, the membrane is designed, at least partially, preferably at its edge, as a sealing element, for example as a sealing ring. In these embodiments, it is arranged around the limb stump, for example in the area of the insertion opening. It optionally prevents the fluid in the pressure chamber from losing pressure along the limb stump. It may advantageously prevent fluid from escaping to the outside of the pressure chamber and thus prevent a drop in pressure inside the pressure chamber.

In some exemplary embodiments according to the invention, the membrane is arranged inside the pressure vessel, at least when the device is in use (ie when the patient's residual limb is inserted into the interior of the pressure vessel) and at least in sections thereof. It is preferably only and/or always present inside the pressure vessel. Alternatively or additionally, it is connected directly or indirectly in a fluid-tight connection to sections of the wall of the pressure vessel.

In some exemplary embodiments according to the invention, the membrane is also present exclusively inside the pressure vessel when the device is in use (ie when the patient's residual limb is inserted into the interior of the pressure vessel).

In some exemplary embodiments according to the invention, the membrane does not protrude from the interior of the pressure vessel, in particular not in the area of a second end face or in the area of the bottom surface.

In some exemplary embodiments of the invention, the membrane is permanently connected to the device. In certain embodiments according to the invention, permanently means that the membrane cannot be detached from the pressure vessel without the use of tools or only in a destructive manner; it can, for example, be permanently and yet detachably connected to the wall by means of a clamping ring or clamping rings (not to be confused with connectors in the sense of the present invention, which can also be provided) and one or more screws. Detachability by means of a tool can advantageously be provided in order to enable the membrane to be replaced, for example due to wear and tear after a large number of uses. In these embodiments, however, it should not be detachable from the pressure vessel by simply slipping it over, pulling it down or the like. At the same time, the permanent attachment can advantageously ensure that the forces transmitted to the membrane via the fluid when the device is used in the pressure chamber cannot detach the membrane from the pressure vessel or from its wall.

In some exemplary embodiments according to the invention, the device has no other axial receptacle for the free stump end other than the membrane and/or no “axial reference compliant means”. The stub end preferably only contacts the membrane. This may be different in other embodiments of the invention.

In some exemplary embodiments according to the invention, the device of the set according to the invention has no, in particular circular, and/or disk-shaped cover of the insertion opening, which is made of rubber, for example, and/or which is optionally integral with an integral central hole. In other embodiments this is different; in such embodiments, the device comprises at least one, in particular circular, and/or disk-shaped cover of the insertion opening, which is made of rubber, for example, and/or which is optionally integral with an integral central hole.

In some exemplary embodiments according to the invention, the device of the set according to the invention, in particular when in use, has no sand, no plaster material, no hardening material, in particular not in the pressure chamber or between the wall and the membrane.

In certain exemplary embodiments of the present invention, the fluid is not or includes sand, solid particles, and spheres, particularly polystyrene spheres.

In certain exemplary embodiments of the invention, the membrane is not made of polyethylene or does not include polyethylene.

In some exemplary embodiments according to the invention, the device of the set according to the invention has no device such as an elastic ring or a rubber ring and in particular no rubber ring, which is provided for fastening the membrane to an outer wall of the pressure vessel. This may be different in other embodiments of the invention. Such a rubber ring would not be a connection within the meaning of the present invention.

In some exemplary embodiments of the present invention, the apparatus does not include or is not in fluid communication with a vacuum source (particularly a vacuum source that is electrically or hydraulically operated).

In certain exemplary embodiments according to the invention, the device has no pressure source and/or no, in particular inflatable, expanding devices or other “expander means” or is not connected to such.

In some exemplary embodiments according to the invention, the device does not have a vacuum connection.

In certain exemplary embodiments of the present invention, the device does not include an air chamber.

In some exemplary embodiments according to the invention, the device does not have any conveyor screws.

In some exemplary embodiments of the present invention, the device is configured to take a negative impression of the residual limb. The negative impression has a wall thickness of preferably 2 mm to 8 mm, particularly preferably 3 mm to 6 mm.

In some exemplary embodiments of the present invention, the device is not configured to take a positive impression of the residual limb.

In some exemplary embodiments according to the invention, the method includes the production of a prosthesis socket, a part thereof, or a complete, ie ready-to-use, prosthesis based on the hardened material without having previously made a positive impression of the limb stump.

In certain exemplary embodiments according to the invention, the prosthesis socket has a wall thickness of preferably 2 mm to 12 mm, preferably 3 mm to 8 mm, particularly preferably 4 mm to 6 mm.

In some exemplary embodiments according to the invention, the at least one connector is attached to a bottom surface, to the wall and/or to the second end face of the pressure vessel, preferably with one of its ends or end sections, while the other end or the other end section is preferably connected to the membrane is.

The connector can fix the membrane inside the pressure vessel by means of this attachment, so that the membrane cannot bulge or turn outwards through the insertion opening, in particular for the advantageously simple insertion of a limb stump into the interior of the pressure vessel.

The connector can be attached to the bottom surface, to the wall and/or to the second end face of the pressure vessel by means of mechanical fastening means, for example by means of hooks, clamp connections, screws, rivets or the like.

In some exemplary embodiments according to the invention, the at least one connector is at least 10 cm long, in others at least 20 cm long, in others at least 30 cm long.

In some exemplary embodiments according to the invention, the at least one connector is not used to connect the membrane in an area of the upper edge of the wall of the pressure vessel and/or not to produce a fluid-tight connection between the membrane and the pressure vessel.

In some example embodiments of the invention, the at least one connector is connected to a reinforced portion of the membrane. A reinforced section of the membrane can, for example, have an increased wall thickness, different materials and/or material coatings.

For example, a reinforced portion of the membrane may have increased strength. By means of the reinforced section of the membrane, increased forces, in particular frictional forces, on the reinforced section, for example when inserting a limb stump into or withdrawing it from the interior of the pressure vessel of the device, can advantageously be dissipated via the connector.

Another section of the membrane that is not, at least not completely, exposed to these forces can have other material properties, for example a more comfortable and softer fit of a limb stump in the To allow membrane in the pressure chamber during the preparation of an impression. In particular, the distal areas of a limb stump are often particularly sensitive to pressure and should therefore be relieved of pressure as much as possible while an impression is being made.

In some exemplary embodiments according to the invention, the reinforced section of the membrane is connected on the one hand to the at least one connector and on the other hand to the wall or the bottom of the pressure vessel.

In some exemplary embodiments of the present invention, at least two connectors are attached to the perimeter of the membrane. Likewise, three, four, five, six or more connectors can be attached to the perimeter of the membrane. The connectors can be fixed at a regular or at an irregular distance from one another on the periphery of the membrane.

In certain exemplary embodiments according to the invention, the pressure vessel has the insertion opening and optionally one or more inlets and/or outlets, which, however, are all provided with one or one closure device for their fluid-tight closure. Otherwise the wall of the pressure vessel or the pressure chamber is fluid-tight in these embodiments.

In some exemplary embodiments according to the invention, the inlets and/or outlets provided with a closing device are part of the wall.

In certain exemplary embodiments according to the invention, the pressure chamber is configured exclusively by the membrane and parts or sections of the wall, or exclusively by the membrane and parts or sections of the wall and fluid-tight connections between the membrane and the wall.

In some exemplary embodiments according to the invention, one end face of the pressure vessel is part of the wall, in particular the end face referred to herein as the second end face.

In some exemplary embodiments according to the invention, the pressure vessel is closed or can be closed in a fluid-tight manner on its second end face.

The pressure vessel may have a first and a second end face. The insertion opening can be an end opening. It is preferably in the first end face or in the area of the first end face.

The membrane can be detachably or non-detachably connected to the wall or another section of the pressure vessel.

In some exemplary embodiments of the present invention, the medical device has at least one outlet that is or enables fluid communication between the pressure chamber and the exterior of the pressure vessel. It also includes a valve, stopcock, or other closure device for reversibly closing the outlet or fluid connection.

The outlet can advantageously be used to lower the pressure present in the pressure chamber by draining fluid from the pressure chamber. This may be necessary or helpful for inserting the limb stump, or for adjusting a depth of insertion of the stump.

In some exemplary embodiments according to the invention, the pressure vessel has a first and a second end face. In this case, the outlet of the pressure vessel is optionally arranged in the area of the second end face or an end face of the pressure vessel.

In some exemplary embodiments according to the invention, the pressure vessel is connected to the pressure source via the outlet or via an inlet which is separate therefrom. There can thus be two passages in the wall, namely outlet and inlet.

In some exemplary embodiments according to the present invention, the pressure chamber of the pressure vessel has or is filled with water or another liquid in its interior. A liquid leads to more reproducible results when making the impression due to its lack of compressibility. Water is the cheapest and most readily available option.

In certain exemplary embodiments according to the invention, the wall of the pressure vessel is transparent at least in sections thereof. This can easily allow the prosthetist to visually monitor the insertion depth and other aspects of the impression taking. In addition, light, e.g. B. UV light penetrate.

In some exemplary embodiments according to the invention, the pressure vessel has at least one transparent in the region Section hereof one or more markers. The insertion depth of the limb stump can be read from them.

In some exemplary embodiments according to the invention, the pressure vessel has a multi-part sealing ring, in particular a thigh sealing ring (not to be confused with a connector in the sense of the present invention), in other embodiments it has no such ring. If provided, this can be detachably connected, for example screwed, to the pressure vessel in the area of the insertion opening or a clamping ring or a fastening ring which carries the membrane. It can prevent or limit the membrane from being blown up to an exterior of the pressure vessel due to the pressure existing beyond the membrane. This can lead to more correct print ratios and results of the impression. In addition, the membrane can be protected from shearing off, for example at the edge of the insertion opening, or from damaging the membrane in some other way, for example in the gap between the limb stump and the edge of the insertion opening. One or more connectors within the meaning of the present invention can also be provided.

In some exemplary embodiments according to the invention, the pressure chamber is formed or delimited by at least one section of the wall and by the membrane. The membrane is connected to the section of the wall, preferably in the area of the second end face of the pressure vessel, in a materially, non-positively and/or form-fitting manner. A connector or a connecting device can be provided for this purpose. In some embodiments according to the invention, the connector can be used to prevent or limited to what is deemed permissible. The connector thus, at least essentially, optionally holds the membrane inside the pressure vessel. This, or the connector, can counteract undesired flotation of the limb residual limb. The buoyancy can have an unfavorable influence on the pressure prevailing in the pressure chamber and by means of the membrane on the limb stump, in that the membrane no longer bears on the stump with uniform pressure in all sections in which it surrounds it. However, when the impression is made, the optimal pressures are not applied to the stump, with the result that the impression made was not made under later loads that occur when walking with the prosthesis to be made. Furthermore, a reduced or prevented buoyancy can make a contribution to protecting the membrane, which is protected against damage inside the pressure vessel by its wall. Advantageously, when the connector is provided according to the invention, there is no need for any other limitation of a raising of the membrane, for example by a ring lying tightly against the thigh. Since such a ring would have to be kept available in a large number of sizes in order to be able to use the device to make impressions of a large number of limb stumps of different thicknesses, there is a simplification that is easy for the person skilled in the art to understand. In addition to simplifying the use of the device, it also means saving material for rings, costs and the like.

In some exemplary embodiments according to the invention, the connector is connected to the membrane in a section of the membrane which lies in the area of the insertion opening.

In certain exemplary embodiments according to the invention, the membrane is connected to the pressure vessel in the area of the insertion opening or the first end face of the latter, and additionally in a second, different area or section of the pressure vessel. The second area can preferably be located inside the pressure vessel and/or in the pressure chamber. The membrane can preferably be connected to the second region by means of the connector. The membrane can preferably only be in indirect contact with the second area, namely optionally by means of the connector, ie preferably not have any direct contact with the second area itself, ie preferably not touch it.

In some exemplary embodiments according to the invention, the second area is an edge area of the bottom surface, the second front surface or side.

In some exemplary embodiments according to the present invention, the connector is an elastic spring or has an elastic element.

In some example embodiments of the present invention, the connector is non-elastic or non-stretchable.

In some example embodiments of the present invention, the connector is adjustable in length. Its length can be adjusted by means of a corresponding adjusting device, which can preferably be adjusted from the outside of the pressure vessel. This increases the distance between the distal end of the membrane and, for example, the bottom surface, lower end face or end face surface of the pressure vessel changed. This allows the membrane to be variably aligned within the pressure vessel, which can allow optimal adjustment of the device of the set according to the invention to the specific limb stump, regardless of its length.

In some exemplary embodiments according to the invention, the connector connects the membrane, directly or indirectly, to an end face of the pressure vessel which is opposite the end of the pressure vessel which has the insertion opening, i.e. in particular to a lower end face, end face or bottom face.

In some example embodiments of the present invention, the connector does not connect the membrane to a central or central portion of the face, face, or bottom surface. This allows or encourages comparatively free placement of the residual limb inserted into the membrane within the pressure vessel without the connector exerting pressure on distal portions of the limb stocking via the membrane.

In some exemplary embodiments according to the invention, a connection is understood to mean a positive and/or non-positive and/or material connection.

In some exemplary embodiments of the invention, the connector is arranged to connect an upper portion of the membrane, in use.

In some exemplary embodiments according to the invention, the connector is arranged to keep a distance between the connector-connected portion of the membrane on the one hand and the connector-connected portion of the bottom surface, lower face or face surface on the other hand within predetermined limits. In the case of a non-elastic connector, the distance can be constant, for example.

In some exemplary embodiments of the invention, the connector is connected directly to the wall. In this case, the connector can be the result of a joining process, for example an adhesive section, a rivet or the like.

In some exemplary embodiments according to the invention, the membrane touches the bottom surface, bottom side or lower end face in the area of its connection, in other embodiments the membrane or material of the membrane does not touch it.

In certain exemplary embodiments according to the invention, the membrane is made of a material or has such a material which has a different elasticity or stretchability of the material in a first direction of the material than in a second direction different from the first direction, the second direction being towards the first direction can optionally be vertical. In these or other exemplary embodiments according to the invention, the specific elasticity or extensibility in the first and/or second of the two directions is achieved by fibers which the membrane has, which are made, for example, of silicone, a silicone matrix or another material, preferably a fluid-tight material , are embedded. Such fibers may run in the first and/or second direction of the membrane, run substantially in the first and/or second direction, and/or act substantially in the first and/or second direction. In these or other embodiments according to the invention, the different elasticities or extensibility are additionally or alternatively achieved by other configurations.

If the membrane is attached to the pressure vessel ready for use or as intended, the first direction can be an insertion direction of the residual limb or a longitudinal direction of the pressure vessel. The second direction can be at an angle, e.g. B. at right angles to the first direction.

Fibers that extend or run or act in the first direction are optionally not stretchable or stretchable only to a small extent. Optionally, they are less extensible than optional fibers that run, extend, or act in the second direction. Fibers running, acting or extending in the second direction, where provided, may be extensible, more extensible or more elastic than those fibers of the first direction; their extensibility can optionally correspond to that of the fibers of the fibers running in the first direction. The fibers running in the first direction are optional, as are the fibers running in the second direction. The extensibility or elasticity of the fibers can correspond to or correlate with the extensibility or elasticity of the membrane. The fibers may be nylon or may include nylon. They can be made of a material with high tensile strength, in particular a material that has a higher tensile strength than the material embedding it. Such a configuration, which, for example, prevents or noticeably restricts longitudinal stretching (which can optionally be the first direction), but at the same time allows stretching of the membrane in the circumferential or radial direction to adapt it to the limb stump, can also prevent the body from flaring up undesirably advantageously counteract perlimb stump. In addition, the ratio between the depth of the pressure chamber and the insertion depth within the membrane can advantageously remain the same. In addition, the above-mentioned multi-part sealing ring or thigh sealing ring can optionally be dispensed with. Furthermore, it may be possible to use only one membrane to manufacture prosthesis sockets according to the invention on a whole series of limb stumps with different thicknesses in cross section. Advantageously, the membrane lies sufficiently tight both in the case of thick and thin residual limbs in order to avoid the wrinkling of the membrane described herein. The transverse or circumferential extensibility, which the membrane can have in some embodiments according to the invention even if the longitudinal extensibility is prevented or limited, contributes advantageously to this.

In some exemplary embodiments according to the invention, the membrane is partially, in at least a portion thereof or completely or in total less than 2 mm thick, preferably less than 1 mm thick. At this thickness, it distorts the difference between the actual geometry of the residual limb and the settable material to an extent that is at best negligible.

In certain exemplary embodiments according to the invention, the pressure vessel has a closable air discharge opening with a corresponding closing device. From this, air can escape from the pressure chamber when it is not closed. This is advantageous when the pressure chamber is filled with a liquid for the first time; the device, if it is to be used filled with liquid, does not have to be purchased and delivered filled with this. It can be filled with air and thus transported much more easily. The existing air can be released from the closable air release opening when filling with liquid.

In some exemplary embodiments according to the invention, the medical device has a device by means of which at least the pressure vessel can be adjusted in height relative to a base on which the device rests or on which the patient is standing with his healthy leg.

In certain exemplary embodiments according to the invention, the wall of the pressure vessel is made of plastic, for example Plexiglas or polycarbonate, or has one or more of these materials.

In certain exemplary embodiments of the present invention, the device does not include a rim or ring with an opening for the patient's thigh that is configured to be releasably connected to the pressure vessel and/or the wall.

In certain exemplary embodiments according to the invention, the pressure vessel and/or the wall does not have an air opening.

In certain exemplary embodiments of the present invention, the proximal portion of the membrane corresponds to the upper portion of the membrane when the device is in use.

The proximal portion may include the entire top half.

It may comprise the top 0-30% or 0-40% of the membrane.

A proximal or upper section of the membrane can extend from the free edge of the membrane or one connected to the pressure vessel, past which the patient enters the membrane with the limb stump when using the device, via the first 10, 20, 30 up to 40 or 50% of the total length of the membrane.

The total length can optionally be determined from the height at which the membrane is clamped or screwed or otherwise connected to the pressure vessel.

The total length can optionally be determined from the insertion opening of the pressure vessel to the distal end of the membrane.

In certain exemplary embodiments of the invention, the connector, the membrane and/or the bottom surface has at least one thread for screwing the membrane or an element connected thereto, directly or indirectly, to the pressure vessel.

In certain exemplary embodiments according to the invention, the connector limits an upward movement of the membrane caused by fluid in the pressure chamber in such a way that a contact point surface between the residual limb and the membrane is at the same level as a transition section in which the pressure chamber is just no longer separated from the wall (or a connected element such as a clamping ring) but is formed by the membrane and/or the membrane is no longer supported by the wall (or an element connected thereto such as a clamping ring) - in particular, radially, laterally or laterally.

In certain exemplary embodiments of the present invention, the membrane is made of made of a material or has such a material, which has fibers in a first direction and/or in a second direction of the material, which are embedded in a matrix or connected to it in some other way.

In certain exemplary embodiments according to the invention, the membrane, which optionally has a matrix, or its matrix, is made of silicone or comprises silicone.

In certain exemplary embodiments of the present invention, some or all of the fibers have a wavy, tortuous, or zigzag course.

In certain exemplary embodiments of the present invention, the membrane is non-extensible or non-elastic in a first direction thereof and/or in a second direction thereof.

In certain exemplary embodiments according to the invention, “non-extensible” or “non-elastic” means that the modulus of elasticity of the component in question (connector, membrane, fibers, etc.) is at least above 700 N/mm ² , preferably above 1000 N/mm ² , particularly preferably above 2000 N/mm ² .

In certain exemplary embodiments according to the invention, "non-extensible" or "non-elastic" means that an elongation of the component in question (connector, membrane, fibers, etc.) is no more than 20%, preferably no more than 10%, preferably no more than 5%, particularly preferably no more than 2% of its length before the component tears or breaks.

In certain exemplary embodiments of the present invention, the membrane, fibers thereof, and/or connector has a modulus such as nylon.

In certain exemplary embodiments according to the invention, a lower and/or distal section of the membrane and /or a section which is in the area of the membrane which faces away from the insertion opening of the pressure vessel and/or faces a bottom surface, by means of at least one connector referred to herein as a distal connector on or with a section of a wall of the fluid container, for example a bottom surface or Side surface thereof, preferably releasably, directly or indirectly attached.

What has been said about connectors, in particular with regard to their material, length, elasticity, extensibility and other properties, in particular material properties, also applies to the connector referred to here as a distal connector, provided this does not result in a contradiction that is recognizable to a person skilled in the art.

The distal connector can be designed and/or provided in any embodiment according to the invention, as in FIG WO 2016/135320 A1 disclosed, the relevant disclosure of which is hereby also made the subject of the present application in its entirety by reference.

In some exemplary embodiments of the present invention, the connector and/or distal connection reside entirely within the pressure vessel without contact with the exterior thereof.

In some exemplary embodiments according to the invention, the pressure vessel and/or a line communicating with it have a manometer which determines or measures the pressure prevailing in the pressure chamber. The orthopedic technician can, for example, use the measured pressure as a basis for the pressure increase mentioned above.

In some exemplary embodiments according to the invention, the membrane can be turned in and/or out, preferably elastically stretchable. In others, it is elastic in one direction, but not elastic or comparatively or significantly less elastic in a direction that is perpendicular thereto.

In some exemplary embodiments according to the invention, the membrane is arranged so that when the pressure chamber is filled with a fluid, this fluid can be slipped through the insertion opening into an exterior of the pressure vessel.

In certain exemplary embodiments of the present invention, the membrane is stretchable but remains closed except for an opening when stretched, similar to a finger of a rubber glove or a balloon.

In some exemplary embodiments according to the invention, the membrane is arranged on the pressure vessel in order to seal it at the front. This is preferably not done with the connector.

In some exemplary embodiments according to the invention, the device has an annular space or cylindrical space between the preferably elastically expandable membrane and the wall of the pressure vessel does not have a mouth of a connecting hose.

In some exemplary embodiments according to the invention, the device has a fastening ring or butt sealing ring which, for example, has or consists of at least two half or partial shells (short: shells). The fastening ring can be placed on the front side of the pressure vessel (and can be connected to it, for example by means of suitable connecting elements, such as screws, purely by way of example), while delimiting the insertion opening for the stump. Optionally or preferably, the fastening ring can prevent the membrane from being pushed open during use of the device. Such a fastening ring or butt sealing ring is not a connector within the meaning of the present invention. Such a ring can be provided in addition to such a connector.

In some exemplary embodiments according to the invention, the device does not have a carriage on which the pressure vessel would be mounted.

In some exemplary embodiments according to the invention, the device has no electrically, hydraulically and/or hydraulically operated or operable device for generating pressure, in particular arranged for generating pressure on the membrane, or such is not connected.

The device, or any component thereof, of the set according to the invention, in particular the membrane and the membrane according to the invention, can be equipped with one or more features in any combination as they are in the WO 2016/135320 A1 are disclosed, the disclosure of which is hereby made the subject of the present application in its entirety by reference.

In some exemplary embodiments of the present invention, the membrane is non-tubular; H. not open at both ends thereof.

In some exemplary embodiments according to the invention, the membrane is made of fluid-tight, in particular water-tight, material. It can be made of silicone or have silicone. It can be made of fiber-reinforced silicone or have such. Instead of silicone, a co-polymer or rubber can be provided.

In some exemplary embodiments according to the invention of the set according to the invention, the at least one energy source is a radiation source, in particular a light source, preferably a UV radiation source, or has such a source.

In some example embodiments of the present invention, the at least one curing or partial curing energy source is coupled to a portion of the pressure vessel.

In some exemplary embodiments according to the invention, the at least one energy source for curing or partial curing is not connected to the medical device, in particular not to a portion of the pressure vessel.

In some exemplary embodiments of the set according to the invention, the medical device has at least one section that is permeable to radiation, in particular light radiation or UV light radiation, in particular in the area of the wall of the pressure vessel, e.g. B. in the form of one or more windows.

In some exemplary embodiments of the kit according to the invention, the material is resin or comprises resin.

In some exemplary embodiments of the set according to the invention, the material is light-curing.

In some exemplary embodiments according to the invention, the material is connected to a connection, in particular a screw connection, for distal prosthesis parts, in particular before it hardens, or the material surrounds this in sections or it is embedded in the material.

In some exemplary embodiments of the present invention, the material is coexisting with or derived from a gypsum material, e.g. B. in sections, z. B. surrounded on one side or on two sides.

In some exemplary embodiments of the set according to the invention, the membrane of the medical device is at least partially permeable to radiation from the energy source, in particular to light, preferably UV light, for example translucent or transparent.

In some exemplary embodiments of the method according to the invention, this includes the further step inserting the limb stump into the blind opening or protuberance formed by the membrane inside the pressure vessel in such a way that the limb stump is surrounded by the membrane at least in sections around its entire circumference, and in such a way that at least in sections between the limb stump and the membrane the deformable material that can be hardened by means of an energy source.

In some exemplary embodiments of the method according to the invention, the material can be in contact with the membrane and/or the skin of the residual limb. Alternatively, the material can be separated from one and/or the other of these two by means of a separating layer, e.g. B. from foil, be separated.

In some exemplary embodiments of the method according to the invention, the limb stump can already be surrounded or wrapped by the material before it is introduced into the pressure vessel. Alternatively, the limb stump can only come into direct or indirect contact with the material in the pressure vessel.

In some exemplary embodiments of the method according to the invention, the limb stump is also surrounded or wrapped at least in sections with a moist plaster bandage.

In some exemplary embodiments of the method according to the invention, the plaster of paris or plaster of paris bandage may be in contact with the membrane and/or skin of the residual limb. Alternatively, the cast or plaster bandage is separated from one and/or the other of these two by means of a separating layer, e.g. B. from foil, separately.

In some exemplary embodiments according to the invention, the limb stump can already be surrounded or wrapped in plaster of paris or a plaster of paris bandage before it is introduced into the pressure vessel. Alternatively, it only comes into direct or indirect contact with this in the pressure vessel.

In some exemplary embodiments of the method according to the invention, this comprises as a further step removing the limb stump with the material surrounding it and curing the material using the energy source outside the pressure vessel.

In some exemplary embodiments according to the invention, the method according to the invention comprises the further step of removing the limb stump with the material surrounding it after the material has hardened using the energy source within the pressure vessel.

In some exemplary embodiments according to the invention, the method comprises the further step of separating the material from the gypsum material or vice versa.

In certain exemplary embodiments of the present invention, the resin used only reacts upon exposure to UV light and only then cures.

In some exemplary embodiments according to the invention, the set according to the invention additionally has fabric stockings impregnated with resin, in particular in different sizes, prefabricated and/or prepackaged in opaque bags.

Can be advantageous when curing the material inside the device that the z. B. cured by the UV light source irradiated resin without developing strong odor and / or heat.

In some exemplary embodiments of the present invention, the resin used is provided in different colors.

In some exemplary embodiments according to the invention, the e.g. B. by means of UV light, cured prosthesis shaft can be used immediately as such, especially without further manual processing.

In some exemplary embodiments according to the invention, it is provided that the z. B. by means of UV light, further process cured prosthetic socket, in particular by means of thermal deformation.

In some exemplary embodiments according to the invention, it is provided that, e.g. B. by means of UV light, to provide material to be cured with a direct distal screw connection to other parts of the prosthesis, in others not.

In some exemplary embodiments of the present invention, the method includes regulating the insertion depth at which the residual limb is inserted into the pressure vessel. This is regulated by opening and/or closing the outlet or the valve or stopcock. Ideally, the valve or stopcock or other shut-off device is closed before the distal end of the limb stump has contacted the second face. In these embodiments it is therefore important ensure that fluid is always present under the distal end of the stump. This allows the residual limb to rest in and on the fluid as desired. This preferably presses over or onto the entire or predominant surface of the material, the plaster bandage in contact with it or the stocking soaked with resin.

In some exemplary embodiments according to the invention, the method includes increasing the pressure prevailing in the pressure chamber of the pressure vessel, in particular by 0.05 to 0.5 bar, in particular by 0.2 to 0.3 bar, in particular in the patient who is Limb residual limb is in the pressure vessel. Increasing the pressure allows to obtain an impression or prosthesis socket formed under higher pressure than usual. A prosthesis socket manufactured on this basis or by means of the method according to the invention can accommodate patients who subject the prosthesis socket to an above-average load, for example during sports, since the prosthesis socket will also be prepared to transfer a correspondingly higher pressure.

In some exemplary embodiments according to the invention, the pressure vessel and/or a line communicating therewith have a manometer which determines or measures the pressure prevailing in the pressure chamber. The orthopedic technician can, for example, use the measured pressure as a basis for the pressure increase mentioned above.

In some exemplary embodiments according to the invention, the pressure is increased by introducing further liquid or further gas into the pressure chamber of the pressure vessel.

In some exemplary embodiments of the present invention, the pressure increase occurs by reducing the volume of the interior or pressure chamber of the pressure vessel.

In some exemplary embodiments according to the invention, the membrane has a radiation, energy and/or light conducting layer or a radiation, energy and/or light conducting section.

In some exemplary embodiments according to the invention, the membrane has a radiation, energy and/or light emitting layer or a radiation, energy and/or light emitting section, or a layer or a section that can be excited to do so. It can thus be provided that the membrane, incorporated into the material forming it (e.g. as disclosed herein), for example between two layers thereof, has at least one light source or UV light source or other radiation device which is actuated when required and thus for Emitting light, radiation, etc. is stimulated. Includes z. B. the provision of UV emitters, which are available as light sources within the membrane and can be made to radiate if necessary, but otherwise preferably do not radiate.

In some embodiments, the device has a voltage source for supplying the energy or radiation source with electrical voltage, or a connection to such a voltage source. In some embodiments, the voltage source is limited to an output voltage of no more than 12V. The voltage source can be used as a voltage source for z. B. the radiation unit or the light source can be used.

In some embodiments, the device has a mount for at least temporarily attaching the radiation source to portions of the device, e.g. B., on the wall on.

In some embodiments, the radiation source is an induction current source.

In some embodiments, the kit includes a pressurization controller for the pressure chamber of the medical device.

The pressurization control device preferably has at least one pressure reservoir connection, a pressure limiting valve and at least one connection to the pressure chamber with a control valve for increasing the pressure and/or a control valve for reducing the pressure in the pressure chamber.

The control valve can be a control valve.

In some exemplary embodiments according to the invention, the pressure reservoir connection is a connection to a pressure source, in particular to a water line. Fluid, in particular water, can be supplied to the pressure chamber from a water line or another reservoir by means of the pressure reservoir connection.

In certain exemplary embodiments according to the invention, the pressure-limiting valve limits the pressure from the fluid supply line at the pressure reservoir connection to a value between 0.7 bar and 0.9 bar, in particular to a maximum of 0.8 bar.

In certain exemplary embodiments of the present invention, the kit, particularly the pressurization control device, includes a pressure gauge. A pressure indicator can be a manometer. The pressure in the pressure chamber can be checked and/or monitored by means of the pressure display. The pressure display can have a redundancy function or a safety function compared to another pressure display, which can be arranged directly on the pressure chamber.

In some exemplary embodiments according to the invention, the set, in particular the pressurization control device, has an emergency stop device. The pressure reservoir connection can be closed or blocked using the emergency stop device. For example, unforeseen pressure peaks or a sudden pressure increase or pressure drop can occur in the supply line to the pressure reservoir connection, which for safety reasons, in particular to protect the limb stump, should be interrupted quickly. This can advantageously be done easily and quickly by actuating the emergency stop device.

In some exemplary embodiments according to the invention, the set, in particular the pressurization control device, has a suction nozzle. The suction nozzle can be arranged downstream of the control valve for pressure reduction of the pressure in the pressure chamber. A negative pressure can be present at the suction nozzle or can be generated by means of the suction nozzle. For example, a suction pump or vacuum pump can be connected to the suction nozzle. A so-called Venturi nozzle or a Venturi tube can also be connected to the suction nozzle. The suction nozzle can be a venturi nozzle or a venturi tube. By means of the suction nozzle, a fluid, in particular water, can be sucked out or emptied out of the pressure chamber of the device according to the invention.

In certain exemplary embodiments of the present invention, the kit, particularly the pressurization control device, has no electrical components. The pressurization control device can preferably have no power connection, in particular no electrical components and/or no power connection, which would be used to change the pressure within the pressure chamber connected to the pressurization control device.

In certain exemplary embodiments of the present invention, the set includes a computing device. This can be part of the medical device or connected to it physically or in a signal connection. However, it can also be independent of the medical device.

The computing device includes an input device (e.g., a keyboard, a scanner, a mouse, an interface, a stick, a storage unit, an interface (Bluetooth or the like), etc.) and an output device (e.g., a monitor, a display, a printer, a storage unit, an interface (Bluetooth or the like), etc.).

The calculation device is configured to use patient-related data, which can be entered via the input device, to determine a target pressure within the pressure chamber and/or to determine a weight by which the patient must be weighed down when using the medical device in order to to achieve a predetermined loading of the membrane 5 recognized as advantageous. The predetermined load may be a pressure that is within a predetermined target range as described herein.

In this case, the calculation device is optionally configured to access stored algorithms. Alternatively or additionally, the calculation device can be configured to access reference data or reference values, which are stored in a look-up table, for example.

Some or all embodiments of the invention may have one or more of the advantages mentioned above or below.

It is obvious that the prosthesis socket is of benefit to the patient due to the regained mobility, especially when standing and walking. When standing and walking, when the socket is loaded as intended, the socket must therefore be particularly comfortable. However, the previously known methods for making a plaster cast, from which a prosthesis socket was made, which do not use a device as described here, do not do this in an optimal way, since they cause the soft tissue displacements in the stump relative to the bony part of the stump , as they occur later when the socket is loaded, cannot be taken into account due to the lack of loading on the residual limb during the plaster cast. The result can lead to an inaccuracy when manufacturing the upper, which is in the cm range even when taking body measurements in precisely defined heights and areas. This is advantageously not the case when the device of the set according to the invention is used when the patient is standing - the residual limb is subject during the measurement or the cast almost identical loads and soft tissue displacements as in the later loading in the socket.

By means of the invention, it is advantageously possible for the first time to make an impression of the patient's stump or prosthesis socket reliably and, above all, reproducibly when the patient is standing while the impression is being made and is straining the stump.

The present invention thus allows an impression to be made as the basis for an upper which fits the wearer comfortably, especially when walking and standing. This requires less manual skill than before.

Thus, the present invention can enable the production of sockets for prostheses of the upper and especially lower extremities of humans in an objective way. The invention thus enables the manufacture of a well-adapted prosthesis socket, while avoiding the purely subjective and costly manual operations required by the prior art methods.

By means of the invention, it is advantageously possible for the first time to obtain feedback from the patient about pressing or painful areas when the patient is standing while the impression is being made and is realistically straining the stump. The subsequent wearing situation of the socket is felt by the patient when using the device of the set according to the invention while standing, so to speak, already during the creation of the impression or the prosthesis socket or during the measurement "in advance"; unsatisfactorily fitting sections of the later socket are thus recognized or anticipated at an early stage. Requests for changes or upholstery can thus already be reported by the patient when the impression is being taken and the orthopedic technician can prepare them.

Since the patient can use the device in a standing position and thereby load the membrane with proportions of his body weight, no provision is required to protect the limb stump from being damaged by axial reaction forces which act through the pressure chamber on the limb stump and displace it from the interior of the pressure vessel could be postponed. In other words, the patient does not have to be held in position relative to the pressure vessel. His body weight can take over.

The optional attachment of the connector to a proximal or upper region of the membrane advantageously avoids radial pressure on the membrane in sections located further distal thereto. This makes it possible to avoid pressure which could cause radial compression of the limb stump lodged in the membrane in an anatomically weaker section of the limb stump compared to more proximal sections. As a result, a more desirable geometry of the impression created can be achieved, particularly in the distal portion of the stump. Tying the connector to a proximal portion of the membrane avoids such deformation of the distal portion of the limb stump, which can advantageously result in correct geometry of the impression.

Compared to the conventional devices of the prior art, the invention makes it possible to produce sockets for prostheses in an objective manner. This ensures better care through improved fit and can reduce manufacturing costs by requiring little or no costly manual reworking and adjustment. In addition, patient care can be accelerated, since the adjustment steps, which are also time-consuming, can be greatly reduced, at least in number, or even eliminated entirely.

Another advantage of the present invention may be that when using the hardening material, e.g. B. the stocking soaked with resin, the hardened socket can be used immediately as a prosthetic socket. A complex creation of impressions and molds, which require a lot of manual skill, can advantageously be omitted. This helps to save time and costs for materials and labor.

• 1 zeigt eine längs geschnittene medizinische Vorrichtung des erfindungsgemäßen Sets in einer ersten Ausführungsform von der Seite;
• 2a, b zeigen die Vorrichtung aus 1 in verschiedenen Ausführungsformen in einer weiteren Schnittebene;
• 3 zeigt eine längs geschnittene erfindungsgemäße Vorrichtung in einer weiteren Ausführungsform von der Seite; und
• 4 zeigt eine längs geschnittene medizinische Vorrichtung des erfindungsgemäßen Sets in einer weiteren Ausführungsform von der Seite.

The present invention is explained below by way of example with reference to the attached drawings, in which identical reference symbols denote the same or similar components. In the figures, some of which are greatly simplified, the following applies:

• 1 shows a longitudinally sectioned medical device of the set according to the invention in a first embodiment from the side;
• 2a, b show the device 1 in various embodiments in a further sectional plane;
• 3 shows a longitudinally sectioned device according to the invention in a further embodiment from the side; and
• 4 shows a longitudinally sectioned medical device of the set according to the invention in another embodiment from the side.

1 shows a longitudinal or in the longitudinal direction (i.e. related to 1 from top to bottom cut device 100 of a set in a first embodiment of the invention. When reference is made herein to "distal" it means a downward position or direction. Accordingly, "proximal" is above, higher or towards there.

The first embodiment shows a pressure vessel 1 with a pressure chamber DK, a wall 3 and a membrane 5. The membrane 5 has a first or proximal membrane section 5a which is connected to an upper edge 7 of the wall 3. FIG. The first membrane section 5a is optionally reinforced in this embodiment, which is due to a thicker wall thickness (in 1 represented by a heavier line width). A reinforced design can alternatively or additionally be implemented by means of a different choice of material, a fiber-reinforced composite material, a material coating or in some other way.

Furthermore, the membrane 5 has a second or distal membrane section 5b which is arranged in the middle section of the membrane 5 and is connected to the first membrane section 5a or is in one piece with it. The second membrane section 5b is optionally not reinforced, resulting in a reduced wall thickness (in 1 indicated by a thinner line width) is shown.

The two different membrane sections 5a, 5b are used for different loading situations of the membrane 5. When inserting and removing a limb stump KS into the membrane 5, and thus into the pressure vessel 1, the first membrane section 5a in particular is stressed by frictional forces between the limb stump KS and the membrane 5 charged. Due to this increased load, the first membrane section 5a is optionally reinforced. The second membrane section 5b in particular has a sealing function and holding function of the limb stump KS in the pressure vessel DK with a lower load compared to the first membrane section 5a.

In this exemplary embodiment, two optional connectors 53, the function of which is described in more detail below, are optionally arranged at the connection point or interface between the first 5a and second 5b membrane section or in the transition area between the two. In particular, the connectors 53 are connected to the first membrane section 5a (optionally alternatively at a location other than that in 1 shown position) connected.

The connection between connectors 53 and membrane section 5a or 5b is denoted by the reference symbol "A". In the example of 1 the connection A is the distance B below the height H and/or the upper edge of the wall 3.

The distance B can optionally be between 0 cm and 40 cm, preferably between 5 and 30 cm, particularly preferably between 8 cm and 10 cm.

The area of connection A is on the left in 1 shown enlarged.

The membrane 5 is preferably detachable by means of the at least two connectors 53 extending from a proximal portion of the membrane 5 from the latter at the bottom surface 4a, alternatively at a region of the wall 3 (such as in its upper, middle or lower region). , fastened.

The proximal area of the membrane 5 is to be understood here, for example, as the upper third of the membrane 5 or as an area in the upper third of the membrane 5 .

The proximal area of the membrane 5 faces the insertion opening 9 or is close to it.

The area to which the membrane 5 is connected to the connector 53 is evidently not in a central, distal section 58 of the membrane. This advantageously avoids radial pressure on the membrane 5 in a distal section due to the connector preventing the limb stump KS from being lifted up. This pressure could cause radial compression of the limb stump KS stuck in the membrane 5, which can lead to an undesired geometry of the impression produced from or with the hardenable material or the prosthesis socket, especially in the distal stump section. The provision of the connector 53 in a proximal portion can help to avoid such deformations of the distal part of the limb stump, which can advantageously lead to a correct geometry of the impression. The connector 53 causes a radial pressure on the limb stump KS in a proximal section, due to its proximal connection to the membrane. There (i.e. proximally or, related to 1 , “above”), however, the limb stump KS has a stronger anatomy and is less susceptible to the radial compression that can be avoided in some embodiments by means of the present invention.

The pressure vessel 1, which is purely optional, as in 1 shown, is cylindrical, optionally has a first end face 2 (above in 1 ) and a second face 4 (below in 1 ) on. The second end face 4 is in the exemplary embodiment 1 sealed with a bottom plate or bottom surface 4a in a fluid-tight manner with respect to an exterior Ä. The bottom surface 4a can be made of the same material as the wall 3. You can be made in one piece with this.

The membrane 5 separates the fluid chamber or pressure chamber DK of the pressure vessel 1 in a fluid-tight manner from an exterior of the fluid chamber or pressure chamber DK, or for example from the exterior Ä, i.e. an environment of the pressure vessel 1, or, as in 1 shown, in relation to a limb stump KS inserted into the membrane 5 or surrounded by it.

The membrane 5 can be connected to the pressure vessel 1 in a fluid-tight manner at an upper, often ring-shaped, rectangular, square or otherwise circumferential edge 7 of the wall 3, or at another location.

The upper edge 7 lies, for example, in a plane in which an insertion opening 9 of the pressure vessel 1 lies, or delimits this on its circumference. The insertion opening 9 is optionally located in the plane H indicated by the dashed line.

The insertion opening 9 serves to insert the limb stump KS, which is wrapped in a moist plaster bandage, into an interior I of the pressure vessel 1.

The interior I is the volume of the pressure vessel 1 delimited by the wall 3. It extends from the second end face 4, which is closed in a fluid-tight manner with the bottom surface 4a, to the insertion opening designated 9 and indicated by a dashed line.

The pressure chamber DK is filled with a fluid, here by way of example with a liquid F indicated by dots. Filling with gas is also covered by the present invention.

In 1 the device 100 is shown in a state in which the extremely schematically indicated limb stump KS of the standing patient is inserted into the interior I in such a way that it is surrounded by the membrane 5 at least in its distal section. The membrane 5 rests on the plaster bandage over the limb stump KS like a second skin, with further layers such as liners or the like being able to be provided between the plaster bandage and the membrane 5 .

The limb stump KS is in the example 1 loaded by the standing patient with his full body weight. Knowing the volume of the interior I or the pressure vessel 1, the quantity of the liquid F is measured in such a way that the residual limb KS can enter the pressure vessel 1 through the insertion opening 9 at least to such an extent that the entire surface of the plaster bandage, but in any case to an extent for relevant to the print, with the membrane 5 is in contact. At the same time, the amount of liquid F is measured in such a way that the distal end of the limb stump KS (below in 1 ) does not touch the bottom of the pressure vessel 1 or is not supported on it. This ensures that it is the pressure of the fluid on which the patient rests with the introduced extremity and that the plaster bandage experiences the same pressure at every point by means of the membrane 5 .

It is 1 it can be seen that the membrane 5, when no limb stump KS is inserted into the pressure vessel 1, floats or drives up due to the pressure of the fluid, here the liquid, and in 1 liquid level not shown adjusts. The shape of the membrane 5, which is in 1 is shown, so represents the form that the membrane 5 assumes under load when it rests against the inserted limb stump KS and through this - in the example of 1 - Is "taken along" under elastic stretching in the depth of the interior I in the direction of the bottom surface 4a.

It is further 1 It can be inferred that the wall 3 and the membrane 5 allow the desired pressure to build up within the pressure chamber DK of the pressure vessel 1 by preventing fluid exchange between the pressure chamber DK and the exterior Ä or leakage of fluid from the pressure chamber DK , but cannot escape from it or degrade.

How 1 as can be seen, the pressure chamber DK is optionally formed by the membrane 5 and at least parts of the wall 3, which also includes the bottom surface 4a of the end face 4 here.

In other than the in 1 In the exemplary embodiment of the present invention shown, the pressure chamber DK can consist of a membrane that is closed all around, which can be located inside I of the pressure vessel 1 like a balloon or a bubble, or can include such a membrane.

Furthermore shows 1 an optional outlet 19' in the side wall or wall 3 of the pressure vessel 1. If available, this could also be provided at another point of the pressure vessel 1, e.g. B. in its bottom surface.

The outlet 19' connects the interior I in the area of the pressure chamber DK with the exterior Ä of the pressure vessel 1. It allows the fill level and/or pressure within the pressure chamber DK to be changed in a targeted manner, for example by allowing fluid to flow out of the pressure chamber DK via the outlet 19 ' is discharged or admitted through it. For this purpose, the outlet 19' is provided with a valve or stopcock that can be closed in a fluid-tight manner and is not shown in detail. Irrespective of its designation as an outlet, it can also be used to let in fluid and thus to fill the pressure chamber DK.

The membrane 5 is in the embodiment 1 connected by means of the connector 53 or the connector 53 purely by way of example to the bottom surface 4a. The connector 53 is optionally not (or only to a small extent) elastic or stretchable. The membrane 5 is optionally also not (or only to a small extent) elastic or stretchable in the longitudinal direction.

The connector 53 optionally allows the membrane 5 to be raised proximally (upwards in 1 ) to a small and/or predetermined extent. Therefore, a more or less ring-shaped bulge 81 occurs on the second end face 2, but in any case its circumference is closed. The expansion 81 is due to the sectional view of the 1 seen as elevations on the left and right of the limb stump KS. The connector 53 may be provided to prevent such bulging 81 .

The membrane 5 rests against the limb stump KS (or a plaster bandage, a liner or the like pulled over it) in a more or less ring-shaped contact point surface 83 that is at least closed in its circumference. The contact point surface 83 is the circumferentially closed line or surface that encompasses the points at which the limb stump KS has the last or final contact with the membrane 5 in the proximal direction. The contact point area could also be referred to as a contact area or line.

At the same time, the membrane 5 rests on its radial circumference in the area of the second end face 2 of the wall 3 in a transition section 85 that is also closed in its circumference or is fastened thereto. The transition section 85 can be understood as an area in which the delimitation of the pressure chamber DK changes from a delimitation by the wall 3 to a delimitation by the membrane 5 . this is in 1 clearly recognizable by the fact that the pressure chamber DK is delimited below the arrowhead of the reference number line for reference number 85 solely by the wall 3, above solely by the membrane 5, which in turn cannot be supported against a section of the wall 3.

The membrane 5 can be fastened in the transition section 85 in a variety of ways. However, in this embodiment, as in any other embodiment, it does not take place by means of the connector 53. The connection of the membrane 5 by means of the connector 53 takes place in the area of the connection A.

The inflation 81 can be adjusted by venting fluid or introducing fluid via the outlet or inlet 19' in cooperation with the connector 53 so that the contact point surface 83 and the transition section 85 are at one and the same height H (H means the height above the bottom surface 4a), indicated by the dashed line in 1 , condition. Once this has happened, according to the experience of the inventor of the present invention, the pressure conditions are optimal for making the impression.

• 1 zeigt einen distalen Verbinder 91, welcher - in jeder beliebigen Ausführungsform - optional vorgesehen sein kann, obgleich er z. B. in 3 nicht gezeigt ist.
• 2a zeigt die Vorrichtung 100 der 1 in einer weiteren Schnittebene B-B. Die Schnittebene B-B zeigt die Vorrichtung 100 im Querschnitt an einer Position in Längsrichtung, in der die Verbinder 53 mit der Membran 5 verbunden sind. Die Blickrichtung der Schnittebene B-B ist in 2a nach unten auf die Bodenfläche 4a gerichtet. In 2a sind vier Verbinder 53, jeweils um ca. 90 Grad in Umfangsrichtung versetzt, angeordnet. Alternativ könnten die Verbinder unregelmäßig über dem Umfang angeordnet sein. Sie können zudem in beliebiger Anzahl und unter beliebigem Abstand zueinander vorliegen (etwa alle 5 cm entlang des Umfangs).

Advantageously, even if the connector 53 is not adjustable in length, it ensures that more than a predetermined amount of buoyancy 81 beyond the height H cannot occur. A predetermined dimension can be 1 to 4 cm, with around 2 cm being particularly preferred.

• 1 shows a distal connector 91, which - in any embodiment - can be optionally provided, although it is e.g. Am 3 is not shown.
• 2a shows the device 100 of FIG 1 in another cutting plane BB. The section plane BB shows the device 100 in cross-section at a longitudinal position where the connectors 53 are connected to the membrane 5 . The viewing direction of the section plane BB is in 2a directed downward toward the bottom surface 4a. In 2a are four connectors 53, each offset by about 90 degrees in the circumferential direction, are arranged. Alternatively, the connectors could be arranged irregularly around the perimeter. They can also be present in any number and at any distance from one another (approximately every 5 cm along the circumference).

The connectors 53 are fixed to the membrane 5 at one end and to the bottom surface 4a at the other end. The limb stump KS is arranged in the middle of the membrane 5 .

The connectors 53 can be connected to each other, such as by, e.g. B. all radiate into an annular device or are connected to an annular device, which is guided around the circumference of the membrane 5 in each case.

2 B shows the arrangement 2a , but with six connectors 53, each offset by about 60 degrees in the circumferential direction. Alternatively, the connectors could be arranged irregularly around the perimeter.

3 shows the longitudinally sectioned device 100 of the set in a further embodiment from the side. In this embodiment the connectors 53 are attached to the wall 3 of the pressure vessel 1 . Functionally, the connectors 53 fastened to the wall 3 have the same task, namely to prevent the membrane 5 from being pushed up undesirably. Fastening to the wall 3 can have advantages with regard to assembly and/or handling during use of the device 100 .

4 shows the longitudinally sectioned medical device 100 of the set according to the invention in a further embodiment from the side.

Reference is made to the explanations of the preceding figures.

The membrane 5 as shown in 4 is stretched elastically in the depth of the interior I in the direction of the bottom surface 4a by the loading by means of an inserted limb stump KS of a patient and is thus in contact with it, in particular without bulges.

Left and right are in the example 4 Light or UV light sources 95 are arranged as examples of energy sources or radiation sources within the pressure chamber DK, here as an example 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 vessel 1, but not in the pressure chamber and/or not in the liquid F. Alternatively, they are provided outside the pressure chamber DK and/or outside the pressure vessel 1 and are not connected to the medical device.

The UV light sources 95, should there be several, as examples of energy sources or radiation sources, can be arranged evenly distributed around the circumference or at different distances from one another. They are arranged, for example, over the entire length of the pressure chamber DK, ie based on the top-bottom direction 4 .

In alternative or supplementary embodiments, the wall 3 of the pressure vessel 1 and its pressure chamber DK can have energy and/or light-permeable sections, similar to windows, and the UV light sources 95 can be arranged outside the pressure vessel 1 . This is also included in the present invention.

The limb stump KS is covered with a stocking S, which in turn has been soaked in resin to produce a prosthesis socket, or consists of resin and/or another hardenable material, or has resin and/or another hardenable material, before it is joined to the limb stump KS was introduced through the opening of the pressure chamber DK into this and into the membrane 5 . The stocking S can have plaster of paris.

An optional vector tower 99, for example made of plastic, can have holes 99' or other radiation-, in particular light-transmissive sections, at least in its uppermost segment, here to transmit light, in particular the UV light of the UV light sources 95, to the tip of the limb stump to let KS advance.

The light radiation 97 from several UV light sources 95 is represented by wavy lines. It causes the resin or other suitable material with which the stocking S is impregnated to fully or at least partially harden. The cured stocking S can then be used directly as a prosthesis socket or can be further processed as a blank for a prosthesis socket, for example by means of thermal deformation and/or by attaching screw connections to other prosthesis sections.

Reference List

100

contraption

1

pressure vessel

2

first face

3

wall

4

second front side, can optionally be closed with the bottom surface

4a

floor space

5

membrane

7

upper edge

5a

proximal or first membrane section; reinforced section of the membrane

5b

distal or second membrane section

9

insertion opening

19'

outlet, inlet

53

Interconnects

58

central or middle area or section of the membrane

81

distension of the membrane

83

contact point area

85

transition section

91

distal connector

95

UV light source

97

UV light radiation

99

vector tower

99'

holes; translucent sections

A

Connection

Ä

Exterior of the pressure vessel

B

distance

DK

pressure chamber of the pressure vessel

I

inside of the pressure vessel

f

fluid or liquid

H

height of the pressure chamber

KS

limb stump

S

Stocking (soaked in resin)

QUOTES INCLUDED IN DESCRIPTION

This list of documents cited by the applicant was generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Patent Literature Cited

• WO 2016135320 A1 [0134, 0145]

Claims (22)

Set for use in making an impression of a limb stump (KS), in particular a lower leg stump, or a prosthetic socket () or a part thereof, the set having or consisting of: - a medical device (100), the device (100) comprising at least: - a pressure vessel (1) with a fluid chamber or a pressure chamber (DK) for receiving or storing a fluid (F), in particular under pressure, the pressure vessel (1) having a wall (3) made of a first material, the Wall (3) delimits an interior (I) of the pressure vessel (1) from an exterior (Ä), the pressure vessel (1) having an insertion opening (9) for introducing the limb stump (KS) into the interior (I) of the pressure vessel (1 ) having; - A fluid-tight membrane (5) made of at least a second material, which is arranged to form or delimit the fluid chamber or the pressure chamber (DK); and - At least one energy source for curing or partially curing a deformable material to obtain an impression of the limb stump (KS) or to obtain a prosthetic socket (); and or - a deformable material, hardenable by means of an energy source, which is not gypsum or not only consists of gypsum. set after claim 1 , wherein the at least one energy source is or has a radiation source, in particular a light source, preferably a UV radiation source (95). Set according to one of the preceding claims, in which the at least one energy source for curing or partial curing is connected to a section of the pressure vessel (1). Set according to one of the preceding claims, wherein the at least one energy source for curing or partial curing is not connected to the medical device (100), in particular not to a section of the pressure vessel (1). Set according to one of the preceding claims, wherein the medical device (100), preferably its wall (3), has at least one section which is permeable to radiation, in particular light radiation or UV light radiation, in particular in the region of the wall (3) of the pressure vessel (1) , having. A kit according to any one of the preceding claims, wherein the material is or comprises light-curing resin. Set according to one of the preceding claims, wherein the deformable material is connected to a connection, in particular a screw connection, for distal prosthesis parts or surrounds or embeds this in sections before it hardens. Set according to any one of the preceding claims, wherein the material is present together with a plaster material or from this z. B. is partially surrounded on one side or on two sides. A kit according to any one of the preceding claims, wherein the medical device (100) comprises: - an outlet (19) which is a fluid connection between the fluid chamber or pressure chamber (DK) and the outside (Ä) of the pressure vessel (1); and - a valve, a locking device or a stopcock, for opening and closing the outlet (19) or the fluid connection. Set according to one of the preceding claims, wherein the membrane (5) of the medical device (100) is made of a material or has such a material which has a different elasticity or extensibility in a first direction of the material than in a second, optionally perpendicular to the first standing, has direction. Set according to one of the preceding claims, wherein the membrane (5) of the medical device (100) is made of a material or has such a material which has fibers (55a, 57a; 55b , 57b), which are preferably embedded in a matrix or preferably connected to it in some other way. A kit according to any one of the preceding claims, wherein the membrane (5) of the medical device (100) is non-extensible or non-elastic in a first direction thereof and/or in a second direction thereof. Set according to one of the preceding claims, in which the membrane (5) of the medical device (100) is permeable at least in sections to radiation from the energy source, in particular to light, preferably UV light. Method of adapting a deformable and energy-curable mate rials to a limb stump (KS) or to create a prosthetic socket or a part thereof for a limb stump (KS) of a patient, with the steps: - providing a set according to one of Claims 1 until 13 ; - Filling the fluid chamber or pressure chamber (DK) of the pressure vessel (1) with a fluid, in particular a liquid (F), or changing a liquid level within the fluid chamber or pressure chamber (DK) in such a way that the membrane (5) at least in sections thereof the entire circumference of these sections is covered by the liquid (F), or in such a way that the membrane (5) arches beyond the insertion opening (9) of the pressure vessel (1) into the outside (Ä) of the pressure vessel (1), or providing a fluid chamber or pressure chamber (DK) filled in this way. procedure after Claim 14 , with the further step: - Inserting the limb stump (KS) into the membrane (5) in such a way that the limb stump (KS) is surrounded by the membrane (5) at least in sections around its entire circumference, and in such a way that at least The deformable material that can be hardened by means of an energy source is present in sections between the limb stump (KS) and the membrane (5). Method according to the preceding claim, wherein the limb stump (KS) is also surrounded or wrapped at least in sections with a moist plaster bandage (125). Procedure according to one of Claims 15 until 16 , with the further step: - removing the limb stump (KS) with the material surrounding it from the pressure vessel (1); and - curing the material using the energy source outside the pressure vessel (1). Procedure according to one of Claims 15 until 17 , with the further step: - curing the material using the energy source inside the pressure vessel (1); and - removing the limb stump (KS) with the hardened material surrounding it from the pressure vessel (1). Procedure according to one of Claims 15 until 18 , with the further step: - Separating the material from the gypsum material or vice versa. Procedure according to one of Claims 15 until 19 , with the further step: - Creation of a prosthesis shaft, a part thereof, or a complete prosthesis, based on the hardened material without previously having made a positive impression of the limb stump (KS). Prosthesis socket, or a part thereof, produced in a device of the set according to one of Claims 1 until 13 or by a method according to any of Claims 14 until 20 . Membrane (5) for use in a set according to one of Claims 1 until 13 and/or in a method according to any one of Claims 14 until 20 , wherein the membrane (5) is transparent and/or comprises or is connected to a light source (95).

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