DE102017114001A1 - Medical device for producing a data model of a limb stump, set, method and adhesive sock - Google Patents

Abstract

The present invention relates to a medical device (100) for use in making a data model of a limb stump (KS), the device (100) comprising at least one pressure vessel (1) having a fluid chamber or a pressure chamber (DK) for receiving or storing a fluid (F), said pressure vessel (1) having a wall (3) of a first material, said wall (3) delimiting an interior (I) of said pressure vessel (1) from an exterior (Ä), said pressure vessel (1 ) has an insertion opening (9) for insertion of the body stump (KS) in the interior (I) of the pressure vessel (1). The apparatus (100) further comprises a fluid-tight membrane (5) of a second material which is arranged to form or confine the fluid chamber or the pressure chamber (DK). Furthermore, the device (100) has an adhesive stocking (215) for covering over the body stump (KS), wherein the adhesive stocking (215) has sensors (225) for producing the data model. In addition, the present invention relates to a set (500) having a medical device (100) according to the invention and a transmitting device (501) and / or a receiving device (501) for transmitting and / or receiving signals (227) of the sensors (225) in the Haftstrumpf (215). Furthermore, the invention relates to a method and a Haftstrumpf.

Description

The present invention relates to a device according to the preamble of claim 1. It further relates to a set according to the preamble of claim 9, a method according to the preamble of claim 11, as well as a Haftstrumpf according to the preamble of claim 14th

Leg amputees can regain mobility with leg prostheses. Modern leg prostheses include various modules (prosthetic socket, knee, lower leg, and foot modules) which can be combined to meet the diverse needs of the prosthesis wearers (hereafter also referred to as wearer or patient) in terms of basic mobility, exercise, and aesthetic ideas ,

The prosthesis stem module establishes the connection between the mechanical replacement of the limb and the remaining limb stump (also referred to below for short as stump) of the prosthesis wearer, for example a lower leg stump, a thigh stump or an arm stump. The prosthesis stem is individually adapted in the prior art to the stump of the future wearer. For this purpose, a plaster cast is often made by means of a moist plaster bandage, which will be the basis of the prosthesis stem and significantly determines its shape. Alternatively, the shape of the limb stump may be digitally detected to subsequently make the prosthesis stem from these digital data.

An object of the present invention is to propose a device for use in the preparation of a data model of a limb stump, in particular of the lower leg stump. It is another object of the present invention to propose a set and a method for making a data model of a limb stump. Another object of the present invention is to propose an adhesive stocking for a limb stump.

The object according to the invention can be achieved by a device (or a system) having the features of claim 1. It can furthermore be achieved by a set having the features of claim 9, by a method having the features of claim 11, furthermore by an adhesive stocking having the features of claim 14.

According to the invention, therefore, a medical device (in short: device) is proposed, which can be used in the production of a prosthesis socket for a limb stump, in particular for a lower leg stump. This can be used, for example, in the manufacture of a lower leg prosthesis stem, on only preferably standing patients.

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

The pressure vessel has a wall which is made of at least or exactly a first material or at least comprises a first material.

The wall of the pressure vessel limits its interior. According to the invention, the interior of the pressure vessel means that space or volume which is predetermined by the geometry of the pressure vessel or encompasses or circumscribed by an outer wall of the pressure vessel. If, for example, the pressure vessel is cylindrical, then the interior of the pressure vessel is the space bounded by the cylindrical jacket surface and the two end faces or die planes. In another example, if the pressure vessel is rectangular, the space of the interior is defined by the result of the multiplication of height, width, and depth of the rectangle. It does not matter in determining the interior whether or not the space corresponding to the interior is fluid-tightly confined. The interior does not describe a fluid-tight closed space, but a volume circumscribed by the wall. That space which does not belong to 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 (which can always be referred to in this connection also the distal end of the stump instead of the entire stump) can be introduced into the interior of the pressure vessel. The insertion opening may be, for example, an open end face or end plane, a passage opening in the wall or an opening which breaks through or interrupts the wall. In the region of the insertion opening the interior is thus not separated by a portion of the wall of the exterior of the pressure vessel. The insertion opening can lie in an inlet opening or in an introduction plane through which the limb stump is introduced into the interior of the pressure vessel.

Furthermore, the pressure vessel has at least one or exactly one fluid-tight membrane. Alternatively, the pressure vessel has no such and im The following diaphragm further described, but only correspondingly suitable and / or provided recording 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. The first and second materials are different.

The wall is designed in one piece or optionally in several parts. A multi-part wall may have a plurality of displaceable sections in order to achieve a small packing volume of the device, for example for transport purposes. The multi-part wall medical device according to the present invention may be referred to as a mobile medical device.

Furthermore, the device according to the invention (or the system) has at least one adhesive stocking for covering and / or for slipping over the body stump. The adhesive stocking thus connected to the body stump has sensors for making a data model.

The set according to the invention has at least one medical device according to the invention. It also has at least one transmitting device and / or one receiving device for transmitting and / or receiving signals from the sensors, which are arranged in the adhesive stocking.

The method according to the invention serves to produce a data model of a limb stump. In this case, a medical device according to the invention is provided. The method comprises the step of detecting signals of the adhesive stocking.

The adhesive stocking according to the invention is for covering over a limb stump ( KS ) in the preparation of a data model of the limb stump ( KS ) and / or prepared.

Further, in each case optionally, the pressure chamber is filled with a liquid, provided a balloon-like closed membrane inside the pressure vessel or the liquid level within the pressure chamber adjusted or changed so that the membrane at least in sections thereof around the entire circumference of these sections from Liquid is covered or bulges beyond the insertion opening into the exterior of the pressure vessel.

Inventive embodiments of each of the aforementioned objects may have one or more of the following features in any combination, unless a specific combination for the skilled person is not as obviously technically impossible to detect. The subject matters of the subclaims also indicate embodiments according to the invention.

In all of the above and / or following embodiments, the use of the term "may be" or "may have" etc. is synonymous with "preferably" or "preferably", etc., and is intended to explain embodiments of the invention.

Whenever numerical words are mentioned herein, those skilled in the art will understand these as indicating a numerically lower limit. If this does not result in a contradiction that is recognizable to the person skilled in the art, the person skilled in the art therefore always reads "at least one" or "at least one", for example, when specifying "a" or "one". This understanding is as well of the present invention as the interpretation that a numerical word such as "a" may alternatively be meant as "exactly one", wherever this is technically possible for those skilled in the art. Both are encompassed by the present invention and apply to all number words used herein.

Whenever referred to herein as spatial references such as "top," "bottom," "upper," or "lower," those skilled in the art will understand them to be a spatial indication with respect to orientation in the attached figures and / or arrangement the device (s) according to the invention in their intended use.

The pressure vessel and / or the fluid-tight membrane, the pressure vessel and / or the fluid-tight membrane, as described by the present applicant under the EN 10 2016 101 257.2 entitled "Apparatus, adapter, system and method for creating a plaster cast of a limb stump of a patient for preparing a prosthetic shaft, especially for the lower limb" filed on 25.01.2016 with the DPMA. The relevant disclosure of that application is hereby incorporated by reference in its entirety, provided that details or a concrete combination are not obvious technically impossible to those skilled in the art.

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

In some exemplary embodiments of the invention, the membrane is arranged to form the pressure chamber or, alternatively, to define it, for example by being part, in particular elastic or in one direction only elastic, part of the wall of the pressure chamber.

In certain exemplary embodiments of the invention, the membrane serves to provide, on its own (eg in the form of a balloon) or alternatively together with portions of the wall, a fluid-tight sealed fluid chamber of the pressure vessel, at least partially or completely inside the pressure vessel to build. Since it can receive and / or hold fluid at 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 interchangeable in certain exemplary embodiments according to the invention and / or in those embodiments in which there is no technical objection to those skilled in the art. What is referred to herein as the "pressure chamber" may also apply to a "fluid chamber."

In some exemplary embodiments of the invention, the pressure chamber is located inside the interior of the pressure vessel when the pressure prevailing in the pressure chamber does not exceed a certain pressure. The pressure chamber differs from this in certain exemplary embodiments according to the invention also to the exterior of the pressure vessel when the pressure prevailing in the pressure chamber acts on the membrane in such a way that the latter bulges forwards through the introduction opening, ie into the exterior of the pressure vessel , The pressure chamber may thus have a variable volume, which depends on the pressure prevailing in the pressure chamber. The latter does not apply to the constant interior of the pressure vessel.

In some exemplary embodiments of the invention, irrespective of the wall opening, a fluid which is above the atmosphere may be pressurized in the pressure chamber.

In certain exemplary embodiments of the invention, the pressure chamber serves to receive or support the distal end of the patient's limb stump inserted into the interior of the pressure vessel. Due to the fluid contained in the pressure chamber, the membrane adapts laterally or peripherally to the distal end of the limb stump covered with the adhesive stocking or to the entire limb stump. In this way it may be possible to apply the limb stump through the membrane with respect to a surface unit, preferably unchanged or the same pressure.

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

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

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

In some exemplary embodiments of the invention, the term "pressure vessel" may be replaced by the term "fluid vessel" or "water vessel."

In certain exemplary embodiments of the invention, the pressure vessel has a cylindrical shape.

In some exemplary embodiments according to the invention, the pressure chamber is designed and / or arranged such that the pressure prevailing in it, inter alia or exclusively, depends on the depth of insertion of the limb into the interior of the pressure vessel, at least in the intended use of the device and in the closed position - and outlets, if available.

In certain exemplary embodiments according to the invention, the membrane is arranged in the region 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 lid, as far as the pressure in the pressure chamber is not substantially different from the atmospheric pressure.

In some exemplary embodiments of the invention, the membrane is arranged to inhibit fluid or mass transfer inside the pressure vessel in its axial direction.

In certain exemplary embodiments according to the invention, the membrane is always arranged in one layer in the axial and / or radial direction.

In some exemplary embodiments according to the invention, the membrane is connected to a first end face of the pressure vessel directly or indirectly with the latter, but not also to a second, the first opposite end face.

In certain exemplary embodiments of the invention, the membrane is flat or balloon-like (i.e., open at one end), but not tubular (i.e., open at both ends).

In some exemplary embodiments of the invention, the membrane is at least partially, preferably at its edge, configured as a sealing element, such as a sealing ring. It is arranged in these embodiments, for example in the region of the insertion opening, around the limb stump, it optionally prevents the fluid which prevails in the pressure chamber from losing pressure along the limb stump. It may advantageously prevent leakage of fluid into the exterior of the pressure chamber and thus a pressure drop in the interior of the pressure chamber.

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

In some exemplary embodiments according to the invention, the membrane is also present exclusively in the interior of the pressure vessel during use of the device (that is to say in the case of the limb stump of the patient introduced 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 container, in particular not in the region of a second end face or in the region of the bottom surface.

In some exemplary embodiments of the invention, the membrane is permanently connected to the device. Permanently means in certain embodiments of the invention that the membrane can not be solved without the use of tools or destructive only from the pressure vessel; It can for example be permanently and yet releasably connected by means of clamping ring or clamping rings and one or more screws with the wall. Tool solvability may be advantageously provided to permit replacement of the membrane, such as due to wear after a variety of uses. However, in these embodiments, it should not be able to be detached from the pressure vessel by simple slipping, pulling down or the like. At the same time, the permanent attachment can advantageously ensure that the forces transmitted to the membrane during use of the device in the pressure chamber via the fluid can not detach the membrane from the pressure vessel or from its wall.

In some exemplary embodiments according to the invention, the membrane and / or the adhesive sock is coated on at least one surface thereof, at least in sections, by means of a friction-reducing material, or consists of or wears it (eg applied by greasing, spraying, or the like, the membrane). This allows the patient to insert the limb sufficiently deep through the insertion opening into the interior of the pressure vessel. In this way, it is advantageously ensured that the membrane does not shift or does not shift excessively laterally along the body member to the proximal side. This, in turn, advantageously ensures that an evagination of the membrane does not occur proximally.

In some exemplary embodiments of the invention, the device has no other axial receptacle for the free stump end than the membrane and / or no "axially reference compliant means". The stump end preferably comes into contact only with the membrane. In other embodiments of the invention this may be different.

In some exemplary embodiments according to the invention, the device according to the invention has no, in particular circular, disc-shaped cover of the insertion opening, which is made of rubber for example and / or which optionally is integral with an integral central hole.

In some exemplary embodiments according to the invention, the device according to the invention, especially in its use, has no sand, no gypsum material, no hardening material, in particular not in the pressure chamber or between wall and membrane.

In certain exemplary embodiments of the invention, the fluid is not or is not sand, non-solid particles, and not spheres, especially no polystyrene spheres.

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

In some exemplary embodiments according to the invention, the device 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. In other embodiments of the invention this may be different.

In some exemplary embodiments of the invention, the device of the invention does not include or is not in fluid communication with a vacuum source (in particular, no vacuum source operated electrically or hydraulically).

In certain exemplary embodiments of the invention, the apparatus of the present invention does not include or is not associated with a pressure source and / or inflators, in particular inflatable, expander or other expander means.

In some exemplary embodiments according to the invention, the device according to the invention has no vacuum connection.

In certain exemplary embodiments according to the invention, the device according to the invention has no air chamber.

In some exemplary embodiments according to the invention, the device according to the invention has no conveying screws.

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 designed 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 membrane and wall.

In some exemplary embodiments according to the invention, one end face of the pressure vessel counts toward the wall, in particular the front side designated herein as the second end side.

In some exemplary embodiments according to the invention, the pressure vessel is closed or closable 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 may be an end opening. It is preferably in the first end face or in the region of the first end face.

The membrane may be releasably or non-detachably connected to the wall or other portion of the pressure vessel.

The pressure chamber may be a space of the pressure vessel, which is closed by the wall and the membrane. The pressure chamber is partially or completely inside the pressure vessel. A stored in the pressure chamber fluid can be trapped by the combination alone between wall (as far as they are possibly openings provided by means of the closures provided according to the invention, valves, cocks, etc. are closed) and membrane.

In some exemplary embodiments of the invention, the multi-part wall of the medical device has a plurality of wall sections or consists of a plurality of wall sections disposed movably relative to one another.

In certain exemplary embodiments according to the invention, wall sections are detachably connected to one another.

In some exemplary embodiments according to the invention, the wall sections are configured or have cylinder sections which are concentric with one another.

In certain exemplary embodiments according to the invention, the wall sections are configured as polyhedral sections or have such. In contrast to round cylindrical sections, polyhedron-shaped sections have planes that are, in the cross-section, perpendicular to the longitudinal axis, a polygon, rewrite or exhibit. For example, the cross-section may be a square or a rectangle with four corners, also a polygon, in particular a regular polygon with equal sides on the circumference, with, for example, six, eight, twelve, sixteen or more corners. By means of polyhedral wall sections a relative rotation, perpendicular to the longitudinal axis, of the multi-part wall sections can be prevented from each other, in particular when they are fully or partially inserted along a longitudinal direction of the medical device into one another. In addition, bodies are with polyhedral cross section dimensionally stable than, for example, body with a round cross section.

In certain exemplary embodiments according to the invention, the pressure vessel has a first end side and a second end side.

In certain exemplary embodiments according to the invention, the tube section and / or the membrane are adjustable in their length and can therefore be used for devices of different heights.

In some example embodiments of the invention, the medical device has at least one outlet which is or enables fluid communication between the pressure chamber and the exterior of the pressure vessel. Further, it has a valve, a stopcock or other closure device for reversibly closing the outlet or the fluid connection.

The outlet can be advantageously used to reduce the pressure present in the pressure chamber by discharging fluid from the pressure chamber. This may be necessary or helpful for introducing the limb stump, or for adjusting an insertion depth of the stump.

The device according to the invention is also suitable, in certain exemplary embodiments according to the invention, for supplying patients who require a thigh prosthesis. The device according to the invention can have a ride-on device for the supply of such patients. This can serve to allow the patient to sit down or support at least in the horizontal direction by means of bony pelvic structures.

The ride-on device may be detachably or permanently connected to a portion of the device or the fluid container, for example with the wall thereof, for example by being plugged on, clamped on, screwed or the like.

The ride-on device may be in the form of a saddle or a portion of a saddle.

The ride-on device may be of the ride-on device as described by the present applicant under the EN 10 2015 102 185.4 entitled "Ride-on device and seating for creating a plaster cast on the seated patient to make a prosthetic stem for the lower extremity" filed with the DPMA on 16.02.2015, or correspond to one, especially anterior, section thereof. The relevant disclosure of that application is hereby incorporated by reference in its entirety.

In a particular inventive exemplary embodiment, the ride-on device extends in a longitudinal direction and in a transverse direction thereof. It has at least one extending in the longitudinal direction of the seat portion on which the patient can sit astride, so as on a saddle, so that the seat portion extends from front to back between the thighs therethrough. It also optionally has at least one laterally extending slipping, sitting or abutment member (hereinafter: abutment member) adapted to restrict slippage of the patient seated astride the seat portion along the seating device or along the seating portion. This optional limitation is such that the patient may be able to slide freely along the seat portion in one direction (posterior relative to the intended patient) along the longitudinal or longitudinal axis of the seat portion, in the opposite (anterior, posterior) direction however, only up to the stop element. The stop element is optional. It must therefore not be provided according to the invention. Its function could, for example, be provided or replaced by the hand of the orthopedic technician. A stop element is preferably included in the ride-on device. The longitudinal direction may be that direction which, when the patient is properly seated or seated on the ride-on device, extends from ventral to dorsal or from front to back or through the thighs. The transverse direction may be that direction which, when the patient is properly seated or seated on the ride-on device, extends from the caudal to the cranial or from the pelvis to the head with respect to the latter.

In some exemplary embodiments of the invention, the pressure chamber is defined or bounded by at least a portion of the wall and by the membrane. The membrane is connected to the portion of the wall, preferably in the region of the second end face of the pressure vessel, cohesively, non-positively and / or positively. For this purpose, a connector, or a connecting device, may be provided. By means of the connector, in some embodiments according to the invention, undesired bulging, wandering, blowing or stretching of the membrane can still be prevented or prevented at the top or in an exterior of the pressure vessel in which the membrane is not laterally supported by the wall, unlike in the interior of the pressure vessel on one as permissible extent may be restricted. The connector thus holds the membrane, at least substantially, optionally inside the pressure vessel. This, or the connector, may counteract undesirable abutment of the limb stump. The expulsion can have an unfavorable influence on the pressure prevailing in the pressure chamber and by means of the membrane on the body stump pressure by the membrane is no longer in all sections in which it surrounds the stump, this applies with uniform pressure. However, with the production of a data model, the optimum pressures on the stump are not the result, with the consequence that the data model was not created under later loads which occur when walking with the prosthesis to be manufactured. Furthermore, a reduced or prevented flare can contribute to the protection of the membrane, which is protected inside the pressure vessel by the wall from damage. It requires the provision of the connector according to the invention advantageously no other limitation of a flop of the membrane, such as by a tight fitting on the thigh ring. Since such a ring would have to be provided in a large number of sizes in order to be able to produce data models for a multiplicity of differently sized body stumps using the device according to the invention, there is a simplification which can be easily understood by the person skilled in the art. It means not only a simplification of the use of the device but also a saving of material for rings, costs and the like.

In some exemplary embodiments of the invention, the connector is connected to the membrane in a portion of the membrane which is not in the region of the insertion opening.

In certain exemplary embodiments of the invention, the membrane in the region of the insertion opening or the first end face of the pressure vessel is connected to the latter, and additionally in a second, different therefrom area or portion of the pressure vessel. The second region may preferably lie in the interior of the pressure vessel and / or in the pressure chamber. The membrane may preferably be connected to the second region by means of the connector. The membrane may preferably be in contact with the second area only indirectly, namely preferably by means of the connector, ie preferably not having any direct contact with the second area itself, so preferably not touching it.

In some example embodiments of the invention, the second region is a central portion or the center of the bottom surface, the second end surface or side.

In some exemplary embodiments of the invention, the connector is an elastic spring or comprises an elastic member.

In some exemplary embodiments of the invention, the connector is not elastic or non-stretchable.

In some exemplary embodiments of the invention, the connector is adjustable in length. By means of a corresponding adjusting device, which is preferably adjustable from the exterior of the pressure vessel, its length can be adjusted. As a result, the distance between the distal end of the membrane and, for example, the bottom surface, lower end face or end face of the pressure vessel is changed. This allows the membrane within the pressure vessel to be variably aligned, which can allow an optimal setting of the device according to the invention on the concrete limb, 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 faces the end of the pressure vessel having the insertion opening, ie in particular with a lower end face, end face or bottom face.

In some exemplary embodiments of the invention, the connector connects the membrane to a central or central area of the face, face or bottom surface. This allows or favors a relatively straight arrangement of the body stump inserted into the membrane within the pressure vessel, which may prevent the membrane from being wrinkled and may promote uniform pressurization. The avoidance of wrinkles can also be advantageous, since wrinkles can make it difficult to measure the limb stump introduced into the pressure vessel or container, in particular digitally and / or automatically.

In some exemplary embodiments according to the invention, a connection is understood as meaning a positive and / or non-positive and / or materially bonded connection.

In some exemplary embodiments of the invention, the connector is arranged to connect a bottom-most portion of the membrane in use, or a central portion of the membrane.

In some exemplary embodiments of the invention, the connector is arranged to provide a distance between the one with the On the other hand, to keep connector-connected portion of the membrane on the one hand and the portion of the bottom surface, lower end face or end face also connected to the connector within predetermined limits. For example, the gap may be constant with a non-elastic connector.

In some exemplary embodiments of the invention, the membrane is directly connected to a central region of the bottom surface, bottom side, or lower end side. The connector may be the result of a joining process, such as an adhesive portion, a rivet or the like.

In some exemplary embodiments of the invention, the membrane contacts the bottom surface, bottom side or bottom end face in the region of its connection, in other embodiments the membrane or material of the membrane does not touch it.

In some exemplary embodiments of the invention, the medical device includes a support on which the standing patient can rest when the body stump is inserted into the interior through the insertion opening.

In some exemplary embodiments of the invention, the medical device includes a suspension device. It allows, for example, to hang the device for making a plaster cast for a forearm prosthesis on the wall. The patient may press the arm against the membrane in a predetermined manner.

In some exemplary embodiments of the invention, the wall of the pressure vessel limits the pressure chamber. Furthermore, it has an inlet which serves for introducing fluid for increasing the pressure prevailing in the pressure chamber of the pressure vessel. The inlet may be the o. G. Outlet or a stand-alone device.

In some exemplary embodiments of the invention, the membrane is partially, in at least a portion thereof, or completely, or less than 2 mm in total, preferably less than 1 mm thick.

In certain exemplary embodiments according to the invention, the pressure vessel has a closable air outlet opening with a corresponding closing device. From this air can escape from the pressure chamber in its non-closed state. This is advantageous when first filling the pressure chamber with a liquid; the device, if filled with liquid, should not be purchased and delivered with it. It can be filled with air and transported much easier. The existing air can be discharged when filling with liquid from the closable air outlet opening.

In certain exemplary embodiments of the invention, the pressure vessel is integral or integral. This can advantageously bring about a reliable tightness of the pressure vessel.

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

In certain exemplary embodiments of the invention, the interior and exterior of the pressure vessel may be separated by one wall each.

In certain exemplary embodiments of the invention, the device has no rim or ring with an opening for the thigh of the patient, which is designed 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 has no air opening.

In some exemplary embodiments according to the invention, the pressure vessel has no struts spaced apart from the wall in its interior, in particular none which have a connection to the membrane and / or in particular none which extend in the longitudinal direction of the pressure vessel.

In certain exemplary embodiments of the invention, at least one, preferably central or central, portion of the membrane is secured to a portion of the wall by means of at least one connector, preferably releasably.

In certain exemplary embodiments of the invention, the membrane is made of or includes a material having fibers embedded in or otherwise bonded to a matrix in a first direction and / or in a second direction of the material.

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

In certain exemplary embodiments of the invention, some or all of the fibers have a wavy, curved, or zig-zag course.

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

In certain exemplary embodiments of the invention, "non-stretchable" or "nonelastic" means that the modulus of elasticity of the component concerned (connector, membrane, fibers, etc.) is at least above 700 N / mm ² , preferably above 1000 N / mm ² , more preferably above 2000 N / mm ² .

In certain exemplary embodiments of the invention, "non-stretchable" or "non-elastic" means that an elongation of the component in question (connector, membrane, fibers, etc.) is not more than 20%, preferably not more than 10%, preferably not more than 5%, more preferably not more than 2% of its length, before the component breaks or breaks.

In certain exemplary embodiments of the invention, the membrane, fibers thereof, and / or the connector have an modulus of elasticity, such as nylon.

In some exemplary embodiments of the invention, insertion occurs when the patient is standing.

In some exemplary embodiments of the invention, the fluid is a non-compressible fluid, in some embodiments of the invention, the fluid is a fluid, such as water.

In some exemplary embodiments of the invention, the membrane is on and / or herausstülpbar, preferably elastically extensible. In others, it is elastic in one direction, but not elastic or comparatively or significantly less elastic in a direction which is particularly perpendicular thereto.

In some exemplary embodiments of the present invention, the membrane is arranged to be slipped into an exterior of the pressure vessel through a fluid through the inlet opening upon filling the pressure chamber with a fluid.

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

In some exemplary embodiments according to the invention, the membrane is arranged on the pressure vessel in order to seal it on the face side.

In some exemplary embodiments according to the invention, the device does not have an orifice of a connection hose in an annular space or cylindrical space between the, preferably elastically extensible, membrane and the wall of the pressure vessel.

In some exemplary embodiments of the invention, the device includes at least one, preferably two or more, cameras, imaging systems, surface scanners, magnetic or laser scanners, 3D scanners, infrared scanners, or other types of scanners, ultrasound devices, or other devices that are suitable and / or configured, capture or measure the adhesive stocking in which the body stump is inserted and / or its volume and / or geometry (eg length, width, surface, outer contour, radii, curvatures, dents, edges, angles and the like) to determine. Based on these measurements, surveys, scans, and the like, it may be possible to manufacture a shaft for the limb stump without having made a plaster cast to do so. In this procedure according to the invention, advantageously no manufacturing of a plaster cast is required. Detecting or surveying is in certain embodiments of the invention a scanning and / or surface scanning of the stump.

The device for measuring, detecting or sensing the limb stump may be configured to obtain a three-dimensional representation of the limb stump or a portion thereof.

The aforementioned means for measuring, detecting or sensing the limb stump such as cameras, imaging systems, scanners, ultrasound devices or other means may be provided distributed over the circumference of the pressure vessel or the pressure chamber, be distributed in identical or mutually different distances on the pressure vessel or at its periphery. They can be integrated in the wall of the pressure vessel. They may be provided movable relative to the wall of the pressure vessel, such as by the pressure vessel or in can rotate its interior, along a circumference and / or along a longitudinal direction of the pressure vessel.

In certain exemplary embodiments of the invention, the device includes a rotatable device that supports and rotates the aforesaid means for measuring, detecting or sensing the body stump.

The aforementioned means for measuring, detecting or sensing the limb stump may also include a light source. For example, a light source directed at and illuminating the limb stump and a camera may be rotated together about the limb stump at a preferably fixed distance (eg, 10 to 20 cm, for example, 15 cm).

In some example embodiments of the invention, the apparatus includes at least one means configured to create or compute a data model of the limb stump or a data model of the stem to be manufactured for the surveyed or scored limb stump.

The data model, also referred to herein as a model, is preferably three-dimensional. It is preferably steady.

In some exemplary embodiments of the invention, the device includes or is in signal communication with a shaping device. The styling device is configured and / or configured to fabricate the prosthesis stem based on the limb stump data model or the limb stump shank model to be produced.

In some example embodiments of the invention, the forming apparatus is a CNC milling apparatus, a rapid prototyping apparatus or a 3D printer (short for: three-dimensional printer).

The membrane has a top and a bottom. In use of the device according to the invention, the upper side of the adhesive stocking and the body stump facing, the bottom limits the pressure chamber. In certain exemplary embodiments of the invention, the membrane has at least on its underside a mark which can be identified or identified as such by the device for measuring, detecting or sensing the limb of the body. The marker may serve as an orientation in the calculation of the volume or surface of the limb stump.

This mark can be an optical and / or haptic mark. It may be a grandeur, a contrast, a color mark, an encoding, a color pattern, a bar code or the like. It can be symmetrical or unbalanced. It is preferably applied to the membrane by the manufacturer or integrated into it. It serves to be recognized and / or evaluated by one of the devices of the device. The software used for this purpose can be programmed to identify the marking and / or to evaluate its position in space.

In some exemplary embodiments according to the invention, the method according to the invention for producing a data model of a limb stump comprises the step of detecting signals of the adhesive sock, wherein the detected signals have previously been preceded by a transmission of signals to metallic and / or magnetic particles in the adhesive sock.

In some exemplary embodiments according to the invention, the method according to the invention for producing a data model of a limb stump comprises the step of generating a data model of the limb stump, wherein a 3D surface and / or a volume model from the acquired signals are generated from the generated data by means of mathematical methods.

In some exemplary embodiments of the present invention, the method of making a limb stump data model of the invention includes the step of transferring the data model to a fabrication facility for manufacturing a stump of the prosthesis without requiring an intermediate step of making a plaster cast prior to transferring the data.

In some exemplary embodiments of the invention, the device does not include a push rod protruding from the pressure vessel having a co-axial anticompression cup with an annular wall at the inner end.

In some exemplary embodiments of the invention, the apparatus has no carriage on which the pressure vessel would be mounted.

In some exemplary embodiments of the invention, the device does not include an electrically, hydraulically and / or hydraulically operated or operable means for generating pressure, in particular arranged to generate Pressure on the membrane, on or is not connected to such.

In some exemplary embodiments of the invention, the method of the invention includes creating a data model based on data acquired by means for detecting, sensing, or measuring the limb stump. Creating a data model can be called building a data model. The data model can be called a model.

The model is preferably a continuous model. It is preferably a three-dimensional model.

In some exemplary embodiments of the invention, ultrasound scanning is performed.

In some example embodiments of the invention, the scanning includes 3D scanning.

In some example embodiments of the invention, the method includes making the prosthetic stem based on the model. It uses a forming process for this purpose.

In some example embodiments of the invention, the method does not include determining and / or using a value of the weight of the patient.

In certain inventive exemplary embodiments, the method does not include creating and / or calculating cross-sections through the limb stump or slice data.

In some example embodiments of the invention, the method does not include predetermining or considering target compression.

In some exemplary embodiments of the invention, the method does not provide for capping the distal stump.

In some exemplary embodiments of the invention, the membrane is not tubular, i. H. not open at both ends thereof.

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

In some exemplary embodiments of the invention, the membrane is made of plastic or comprises a plastic. A plastic may be, for example, polyamide.

In some exemplary embodiments of the invention, the membrane is made of rubber or comprises at least one rubber. The rubber may be a synthetic rubber. A synthetic rubber may be, for example, chloroprene rubber. Chloroprene rubber may be referred to as polychloroprene or chlorobutadiene rubber. The synthetic rubber may be foamed.

A rubber membrane may be coated on one or both sides. The coating may be a textile coating, wherein the textile coating may consist of the plastic polyamide or may have this. The coating of the rubber may be referred to as laminating (bonding) the rubber to a textile fabric.

In some exemplary embodiments of the invention, the membrane is coated on one or both sides, in whole or in part, such as with a water-impermeable coating.

In some exemplary embodiments of the invention, the adhesive stocking may be a liner. A liner may be a textile stocking which in practice is regularly pulled over the body stump.

In some exemplary embodiments of the invention, the sensors and / or the transmitting device and / or the receiving device are not based on an optical system or a laser-based system.

In some exemplary embodiments of the invention, the pressure vessel is at least partially made of plastic.

In some exemplary embodiments of the invention, the pressure vessel is at least partially made of glass. Glass may be referred to as an amorphous solid. Glass can consist predominantly of silicon dioxide or have this. Glass may also consist of or include organic materials. A glass of organic materials may be a plastic glass, such as acrylic glass.

In certain exemplary embodiments according to the invention, the transmitting device and / or receiving device for transmitting and / or receiving signals from the sensors of the adhesive sock are not contained and / or integrated in a sensor glove. A sensor glove may be prepared to scan a limb stump to measure anatomical landmarks, for example.

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

It is obvious that the prosthesis stem is of benefit to the patient due to the recovered mobility, especially when standing and walking. When standing and walking, when the shaft is loaded as intended, the shaft must therefore sit comfortably in a special degree. However, the previously known methods for making the plaster cast or for measuring the stump are not in an optimal way, since they the soft tissue displacements in the stump about relative to the bony portion of the stump, as they later occur under load of the stem, lack of stress of the stump during surveying or plastering. The result can lead to an inaccuracy in the manufacture of the shaft, which is even in the removal of body measurements in well-defined heights and areas in the cm range. This is advantageously not the case when using the device according to the invention when the patient is standing - the stump is subject to almost identical loads and soft-tissue displacements during the measurement for making a data model as in the later load in the shaft.

By means of the invention, it is advantageously possible, for the first time during the preparation of the data model and stressing the stump, to measure the stump reliably and, above all, reproducibly in order to obtain a data model which reflects the stump.

Thus, the present invention allows to obtain a stump model as a basis for a shaft which fits the wearer comfortably, especially when walking and standing. It is less manual skill than previously required.

Thus, the present invention can enable the fabrication of upper and lower limb prosthesis shafts in an objective manner based on directly obtained measurement data. The invention thus makes it possible to produce a well-adapted prosthesis stem, while avoiding the purely subjective and manually performed cost-intensive activities which are necessary in the prior art methods.

In this case, it is advantageously possible according to the invention and, in certain embodiments, to use a purely external scanning or measurement or imaging. This is much less expensive, both in terms of the evaluation of their measurements and the cost of acquiring the necessary facilities.

By means of the invention, it is also possible, for the first time, to obtain feedback from the patient about oppressive or painful areas when surveying the patient during the preparation of the data model and thereby stressing the stump realistically. The later wearing situation of the shaft is perceived by the patient when using the device according to the invention standing up, so to speak, as "already" during the measurement; Unsatisfactory fitting sections of the later shaft are recognized and anticipated at an early stage. Change requests or padding requests can already be registered by the patient during the measurement and prepared by the orthopedic technician. This can save a great deal of work and time over the length of time that passes until the appropriate, final shaft is available.

In many exemplary embodiments according to the invention, advantageously there is no need for access to a source of electrical voltage, compressed air or a water pipe. The device can therefore be used independently and mobile. This relates to the entire device in some exemplary embodiments of the invention. In other exemplary embodiments of the invention, the pressure vessel does not have access to a source of electrical voltage, but certain devices of the device, such as those for surveying, sensing, etc., are configured with access to a voltage network.

The invention, in contrast to the conventional methods of the prior art, makes it possible to create prosthesis shafts in an objective manner. This ensures better fit through improved fit and can reduce manufacturing costs by requiring little or no costly manual reworking and customization. In addition, the patient care can be accelerated because the time-consuming adjustment steps can be at least in number greatly reduced or even eliminated altogether.

• 1 zeigt eine längs geschnittene erfindungsgemäße medizinische Vorrichtung;
• 2 zeigt ein erfindungsgemäßes Set mit der erfindungsgemäßen Vorrichtung, einer Sende- und/oder Empfangseinrichtung und einer Signalverarbeitungs- und/oder Auswerteeinrichtung;
• 3 zeigt die erfindungsgemäße Vorrichtung mit einem Verbinder am unteren Endbereich der Membran; und
• 4 zeigt einen erfindungsgemäßen Haftstrumpf in einer Seitenansicht.

The present invention will be described below with reference to the accompanying drawings, in which identical reference numerals refer to the same or similar Designate components, explained by way of example. In the partially simplified figures:

• 1 shows a longitudinally sectioned medical device according to the invention;
• 2 shows an inventive set with the device according to the invention, a transmitting and / or receiving device and a signal processing and / or evaluation;
• 3 shows the device according to the invention with a connector at the lower end portion of the membrane; and
• 4 shows a Haftstrumpf invention in a side view.

1 shows an exemplary, longitudinal or longitudinal (ie based on 1 from top to bottom) cut device 100 of the page. The device 100 has at least one pressure vessel 1 with a wall 3 , a membrane 5 and an adhesive stocking 215 on.

The pressure vessel 1 which is purely optional as in 1 is cylindrical, optionally has a first end face 2 (above in 1 ) and a second end face 4 (below in 1 ) on. The second front side 4 In the exemplary embodiment, FIG 1 with a bottom plate or bottom surface 4a fluid-tight against an exterior Ä locked. The floor area 4a can be made of the same material as the wall 3 be made.

The membrane 5 separates a fluid chamber or pressure chamber DK of the pressure vessel 1 fluid-tight with respect to an exterior of the fluid chamber or pressure chamber DK , or for example, to the exterior Ä , So an environment of the pressure vessel 1 , or, as in 1 shown opposite to one in the membrane 5 introduced or surrounded by this limb KS ,

The membrane 5 may be at an upper, often annular, rectangular, square or otherwise circumferential edge 7 the wall 3 , or elsewhere, with the pressure vessel 1 be connected fluid-tight.

The upper edge 7 lies in a plane in which an insertion opening 9 of the pressure vessel 1 is, or limits this to the extent. The insertion opening 9 lies in the plane indicated by dashed line.

The insertion opening 9 serves the insertion of the adhesive stocking 215 coated limb stump KS in a heart I of the pressure vessel 1 ,

The inner I is the one from the wall 3 limited volume of the pressure vessel 1 , It ranges from the one with the bottom surface 4a closed fluid-tight, second end face 4 to the designated 9, indicated by dashed line insertion.

The pressure chamber DK is filled with a fluid, here exemplified with a liquid indicated by dots F , Gas filling is also covered by the present invention.

In 1 is the device 100 shown in a state in which the extremely schematically indicated limb stump KS of the standing patient in the heart I is introduced such that it at least in its distal portion of the adhesive stocking 215 and the membrane 5 is surrounded. The membrane 5 lies with the adhesive stocking 215 together on the limb stump KS like a second skin on.

The limb stump KS is preferably burdened by the standing patient with its full body weight. The amount of liquid F is aware of the volume of the interior I or the pressure vessel 1 such that the limb stump KS at least so deep through the insertion opening 9 through into the pressure vessel 1 can occur that the entire surface of the Haftstrumpfs 215 but at least as far as the preparation of a data model of the limb stump KS relevant, with the membrane 5 in contact. At the same time, the amount of liquid F optionally sized so that the distal end of the limb stump KS (below in 1 ) the bottom of the pressure vessel 1 not affected or not supported. This ensures that it is the pressure of the fluid on which the patient is resting with the inserted extremity, and that the adhesive stocking 215 by means of the membrane 5 experiences the same pressure at every point.

It is the figure removable, that the membrane 5 then, if no limb stump KS in the pressure vessel 1 is introduced, by the pressure of the fluid, here the liquid, floats or drifts and a in 1 not shown liquid level sets. The shape of the membrane 5 , in the 1 is shown, thus represents that form which the membrane 5 under load when applied to the inserted limb stump KS and by this - in the example of the 1 - under elastic stretching in the depth of the interior I towards the bottom surface 4a "taken down" is.

It can also be seen from the figure that the wall 3 and the membrane 5 in that it provides a fluid exchange between the pressure chamber DK and the exterior Ä prevent or leakage of fluid from the pressure chamber DK Prevent, allow the desired pressure within the pressure chamber DK of the pressure vessel 1 build up, but not escape from it or can break down.

As 1 it can be seen is the pressure chamber DK thus from the membrane 5 and at least parts of the wall 3 formed, to which here also the floor area 4a the front side 4 counts.

In other than the one in 1 shown exemplary embodiment of the present invention, the pressure chamber DK from a completely enclosed membrane, similar to a balloon or a bubble inside I of the pressure vessel 1 may exist, exist or include such.

For the in 1 or in a pressure vessel shown in one of the following figures 1 applies as well as for the pressure vessel of any other embodiment according to the invention that this may have a non-round, preferably a square, cross-section instead of a round cross-section. The cross section may, for example, be rectangular, polygonal or square. The last-mentioned cross-sections can be used in particular in the automatic measurement of the device 100 introduced limb stump KS by means of a camera or the like as described herein, advantageously avoid or reduce artifacts which may arise due to the curved peripheral surface.

The Haftstrumpf 215 has sensors 225 on, which are shown simplified in the detail enlargement A as circular points. The sensors 225 are purely exemplary in the Haftstrumpf 215 However, equally equidistant to each other, but also not äqidistant and / or in a different arrangement, for example on the inside and / or on the outside of the Haftstrumpfs 215 be arranged. The sensors 225 For example, in the distal end region (in 1 below) of the limb stump KS be closer to each other to achieve a higher resolution in the preparation of a data model. The sensors 225 may be referred to as detectors, transducers, transducers or probes.

The sensors 225 can be active or passive sensors. Active sensors 225 can generate signals 227 (as wavefront indicated) send out without having to be activated from the outside. Active sensors 225 may have a power supply, for example, they are powered by cable or by means of power storage elements. Passive sensors 225 may, purely by way of example, be ferromagnetic iron particles which can be activated (magnetized) by means of an external magnetic field and subsequently detected.

The sensors 225 can be position sensors or be designated as such. You can get signals 227 transmit the position of the transmitting sensors exclusively or in addition to measured values 225 specify.

The sensors 225 may be based on different measurement principles, for example as resistive sensors, inductive sensors, magnetic field sensors, magnetoelastic sensors, capacitive sensors, piezoelectric sensors, optoelectronic sensors, electrochemical sensors or temperature sensors. Alternatively and / or additionally, the sensors 225 are detected as passive particles by means of mechanical waves (eg ultrasonic waves) whose signals 227 reflected and from other sensors outside the pressure vessel 1 , z. B. by means of piezoelectric transducer, converted into electrical signals and can be further processed.

By means of the sensors 225 in the adhesive stocking 215 can the outer contour of the limb stump KS be determined. Depending on where the sensors are 225 exactly in or on the Haftstrumpf 215 can be located and offset, an offset can be determined and included in the further data processing to the exact outer contour of the limb stump KS to determine. The offset takes into account, for example, the thickness of the Haftstrumpfs 215 and the exact position of the sensors 225 in or on the adhesive stocking 215 ,

The emitted signals 227 the sensors 225 can be obtained from receiving equipment (see 2 ) outside the device 100 be received. Likewise, passive sensors of transmitting devices (see 2 ) are activated, for example by magnetic fields.

2 shows an exemplary set according to the invention 500 with the device according to the invention 100 , a transmitting and / or receiving device 501 , as well as a signal processing and / or evaluation device 503 of the page.

The transmitting and / or receiving device 501 can as a transmitting device 501 , as a receiving device 501 or combined as a transmitting and receiving device 501 be designed. For example, at the periphery of the pressure vessel 1 several transmitting devices 501 be arranged to emit a magnetic field. By way of example, the in 2 left arranged transmitting device 501 signals 227 in the direction of the Haftstrumpfs 215 out.

Between the transmitting devices 501 , above, below or at another location relative to the transmitting devices 501 , can several reception facilities 501 be arranged to from the sensors 225 emitted signals 227 to receive, see 2 right. These received signals 227 can, for example, wired or wireless, to a signal processing device 503 and / or to an evaluation device 503 for processing and / or evaluating the signals 227 the sensors 225 be transmitted. The signal path 505 (eg, wired or wireless) is indicated by broken lines.

In the signal processing device 503 or the evaluation device 503 can the signals 227 that of the individual sensors 225 were recorded, further processed and evaluated. For example, the singular signals 227 , which can be regarded as a so-called vector-based point cloud, to a surface, in particular to a 3D surface, further processed. For this, known methods (eg rendering) are available. From this digital data (vector-based point cloud and / or 3D surface), a prosthesis shaft can then be produced, for example by means of a 3D Printer or a milling machine as a production line.

3 shows the device according to the invention 100 with a connector 53 at the lower end of the membrane 5 in an exemplary embodiment.

The membrane 5 is - preferably in its distal central or central portion or region - with a portion 51 of the wall 3 or the face 4 positively connected. In the in 3 the embodiment shown is the adhesion through the connector 53 which causes itself from a distal end of the membrane 5 up to section 51, here purely optionally the floor area 4a the pressure chamber DK , extends.

The connector 53 can, as in 3 exemplarily shown to be a thread. Any other suitable connector, such as tape, Velcro, or the like, is also encompassed by the present invention.

The connector 53 holds the membrane 5 preferably in the region of the second end face 4 of the pressure vessel 1 , in particular in the area of the floor area 4a and preferably in its center or center, non-positively and / or positively and / or cohesively with the pressure vessel 1 or floor space 4a connected.

It is preferred that the connector 53 at least in the use state of the device 100 , so in the pressure chamber DK inserted limb stump KS a flow around the distal end of the limb stump KS completely or substantially completely. A flow around the limb stump KS is in 3 down to the area corresponding to the cross-section of the connector 53 corresponds, thus still possible advantageous. In this way, a buoyancy or the pressurization of the distal portion of the limb stump that is so important for readjusting or recapturing the later load situation in the finished shaft can continue unchanged KS done by the fluid.

In addition to the in 3 shown connector 53 several or more connectors may be provided. These can be like the connector 53 with the bottom surface 4a be connected. You can alternatively or additionally to another section of the wall 3 as the end face or bottom face 4a with the pressure chamber DK or the pressure vessel 1 be connected. This also applies to the in 3 shown connector 53 ,

The connection between connectors 53 on the one hand and wall 3 or floor space 4a on the other hand - how independently of this the connection between connectors 53 on the one hand and membrane 5 on the other hand - an adhesive bond, a screw connection, a plug connection, a snap connection, a latching connection or the like. It can be solvable or insoluble.

The in 3 The connector shown is preferably not elastically extensible. He is preferably not stretchy.

4 shows an example Haftstrumpf invention 215 in a perspective side view. In detail view A are, according to the description of 1 , which simplifies as sensors shown points 225 and the signals emitted by way of example 227 , visible, noticeable.

The Haftstrumpf 215 In one embodiment, at least in sections, an elastic material.

LIST OF REFERENCE NUMBERS

100

contraption

1

pressure vessel

2

first end face

3

wall

4

second end face, may optionally be closed with the bottom surface

4a

floor area

5

membrane

7

upper edge

9

insertion

53

Interconnects

215

trump detention

225

Sensors (of the adhesive stocking)

227

signals

500

Set with device and transmitting and / or receiving device

501

Transmitting and / or receiving device

503

Signal processing and / or evaluation

505

pathway

DK

Pressure chamber of the pressure vessel

I

Heart of the pressure vessel

F

Fluid or fluid

Ä

Exterior of the pressure vessel

KS

Limb stump

QUOTES INCLUDE IN THE DESCRIPTION

This list of the documents listed by the applicant has been 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.

Cited patent literature

• DE 102016101257 [0023]
• DE 102015102185 [0077]

Claims (15)

Medical device (100) for use in the preparation of a data model of a limb stump (KS), in particular a lower leg stump, the device (100) comprising at least: - A pressure vessel (1) having a fluid chamber or a pressure chamber (DK) for receiving or storing a, in particular pressurized fluid (F), wherein the pressure vessel (1) has a wall (3) made of a first material, wherein the Wall (3) an interior (I) of the pressure vessel (1) with respect to an exterior (Ä) limited, wherein the pressure vessel (1) has an insertion opening (9) for inserting the body stump (KS) in the interior (I) of the pressure vessel (1 ) having; and - A fluid-tight membrane (5) made of a second material, which is arranged to form or limit the fluid chamber or the pressure chamber (DK); and - An adhesive sock (215) for coating over the body stump (KS), wherein the adhesive sock (215) sensors (225) for making the data model. Medical device (100) according to Claim 1 wherein the sensors (225) are magnetic and / or metallic particles. Medical device (100) according to Claim 1 or 2 wherein the sensors (225) are position sensors. Medical device (100) according to Claim 1 or 2 , wherein the pressure vessel (1) at least partially made of plastic. A medical device (100) according to any one of the preceding claims, wherein at least a portion of the membrane (5) is secured to a portion of the wall (3) by means of at least one connector (53), preferably releasably. Medical device (100) according to one of the preceding claims, wherein at least one of the membrane (5) by means of at least one connector (53), preferably releasably, on a bottom surface (4a) or on the second end face (4) of the pressure vessel (1), and preferably in a central or central area or portion thereof. Medical device (100) according to one of Claims 5 or 6 wherein the connector (53) is non-elastic and / or non-stretchable. Medical device (100) according to one of Claims 5 to 7 wherein the connector (53), the membrane (5) and / or the bottom surface (4a) at least one thread for screwing the membrane (5) or an associated element, directly or indirectly, with the pressure vessel (1). Set (500) with - at least one medical device (100) according to one of Claims 1 to 8th ; and - a transmitting device (501) and / or a receiving device (501) for transmitting and / or receiving signals (227) of the sensors (225) in the adhesive sock (215). Set (500) according to the preceding claim, with a signal processing device (503) and / or an evaluation device (503) for processing and / or evaluating the signals (227) of the sensors (225). A method of making a data model of a limb stump (KS), comprising the steps of: - providing a medical device (100) according to one of Claims 1 to 8th ; - detecting signals (227) of the adhesive sock (215); Generating a data model of the limb stump (KS). Method according to the preceding claim, with the further step of transferring the data model to a production plant for producing a prosthesis stump. Method according to the preceding claim, wherein the manufacturing plant is a 3D printer or a milling machine. Adhesive sock (215) for covering and / or slipping over a body stump (KS), wherein the adhesive sock (215) sensors (225) for making a data model. An adhesive stocking (215) according to the preceding claim, wherein the adhesive stocking (215) at least in sections comprises an elastic material.

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