CH712953A1 - Method for adapting a prosthesis stem and prosthesis stem. - Google Patents

Abstract

A method for producing a prosthesis shaft for attachment to a limb stump (0) is provided, which can be carried out without the aid of a prosthetic technician and achieves a simple, cost-effective and quick yet comfortable adaptation of the prosthesis shaft. This is done by coating a tubular multi-walled prosthetic shoe (10) comprising a skin patch (100) and a flexible sheep sheath layer (101) joined together by connecting seams (102) forming a gap (12) over the limb stump (0) of the prosthesis shoe (10) with a cut outer shell (11), with locking means arranged on a shell outer surface with clamping means and subsequent clamping of the outer shell (11) or the inner diameter of the outer shell (11) around the prosthesis shoe (10) before a gap (12 ) between the skin support (100) and flexible sheep sheathing (101) is foamed with a foam material, whereby a foam layer (12) is formed and final curing of the foam layer (12).

Description

description

Technical Field The present invention describes a method for producing a prosthesis shaft for attachment to an extremity stump, a prosthesis shaft for an exoprosthesis for fastening to an extremity stump, a method for producing a prosthesis, with the prosthesis shaft and a prosthesis comprising a prosthesis shaft with the procedure.

PRIOR ART There are more than 10 million people worldwide who need an exoprosthesis in the form of a hand prosthesis. Many of them are children and adolescents, but often cannot use a prosthesis, which significantly limits the lifestyle of those affected. Many commercially available (bio-) mechanical hand / forearm prostheses are also aesthetically and functionally often not very appealing and cumbersome to handle and manufacture. The industry strives to produce novel, modular, high-quality, and affordable hand prostheses. This is particularly important for children and adolescents, as they need to be adjusted at shorter intervals due to growth and development as well as newly discovered needs.

It is known that for the manufacture of an individual orthopedic prosthesis socket, a negative form of the corresponding part of the body of a person is produced before the actual prosthesis socket can be created. This has to be done by an orthopedic mechanic in an orthopedic workshop today, which is costly and time-consuming. A first prosthesis socket is only finished several weeks after the negative mold has been created.

Since only the body shape is molded in the unloaded state when using a rigid negative form, the prosthesis sockets thus produced can usually not be used in this way. An orthopedic mechanic requires a great deal of experience and intuition so that corresponding changes in relief due to mass and volume shifts on the unloaded part of the body can be anticipated. In practice, the prosthesis socket created must be adjusted further so that there are no pressure points on the prosthesis wearer.

Accordingly, even when the cost of the exoprosthesis itself is reduced, the adaptation of a corresponding orthopedic aid is still a time-consuming and labor-intensive trial-and-error process, in which ultimately only suboptimal results are often achieved. The adjustment of the prosthesis socket is still the responsibility of a specialist, so that there is no cost reduction in sight for the prosthesis wearer in this direction.

Recently, the quality of the desired prosthesis sockets has been improved, the parts of the body of interest being imaged using imaging methods or being electronically measured using scanners, so that a prosthesis socket can be calculated by means of a computer and then manufactured. These procedures are technically even more complex and the time until the finished prosthesis socket has not been shortened significantly. A specialist is also still required who can operate the devices and thus manufacture and adapt a prosthesis socket before the exoprosthesis can be used.

The present invention has for its object to provide a method for adapting a prosthesis socket to which an exoprosthesis can be attached, which can be carried out without the help of a prosthesis technician and allows a simple, inexpensive and quick, yet convenient adjustment of the prosthesis socket.

It was the aim to produce a prosthesis socket or a finished prosthesis, which can be quickly adapted to a limb stump at room temperature and with reduced waiting time without complex equipment and process steps, the prosthesis socket being easily and quickly tightened and adjusted.

Brief Description of the Drawings A preferred embodiment of the subject matter of the invention is described below in connection with the accompanying drawings.

Fig. 1 shows a perspective view of a tubular prosthetic shoe, sewn from a skin pad and a flexible shaft cover layer, while

Fig. 2 shows a plan view of a cut outer shell made of a plastic material before rolling up.

Fig. 3 shows a perspective view of the prosthesis socket with a tubular prosthetic shoe, wrapped outer shell and fastening of a closure device, during the injection of a foam layer between the skin cover and the flexible socket cover layer.

CH 712 953 A1

FIG. 4 shows a partial section from FIG. 3 in the region of the distal shell opening of the prosthesis socket.

5 shows an exploded perspective view of a prosthesis comprising the prosthesis socket, a coupling and an exoprosthesis, which is designed here in the form of a hand prosthesis, after manufacture and before attachment to an extremity stump.

6 shows a perspective exploded drawing of a prosthesis, the outer shell having longitudinal slots and a modified closure device being used.

Description The prosthesis socket 1 presented here can be attached to an extremity stump 0 and comprises a tubular prosthetic shoe 10, which is presented here in detail in FIG. 1. The tubular prosthetic shoe 10 is designed to be flexible, comprising a skin overlay 100 and a flexible shaft covering layer 101, connected by connecting seams 102. The connecting seams 102 are preferably created by welding and gluing. A flexible double-walled prosthetic shoe 10 is thus achieved. This prosthetic shoe 10 or the skin pad 100 and the flexible shaft covering layer 101 are produced on the basis of a cutting pattern.

In Fig. 1, the prosthetic shoe 10 is shown before forming a double-walled hose. For this purpose, the prosthetic shoe 10 is folded over, as indicated by the two arrows, and the longitudinal sides L are connected to one another. The tubular prosthetic shoe 10 encloses the limb stump 0. Here, the prosthesis shaft 1 is shown using the example of a forearm prosthesis shaft 1 for an arm prosthesis or hand prosthesis. The connection of the skin overlay 100 and the flexible shaft covering layer 101 must be such that a foam to be inserted later can be held in the space between the skin covering 100 and the flexible shaft covering layer 101.

The skin overlay 100, facing the paper plane in FIG. 1, is made of an elastic material which should be compatible with the skin, since it rests the limb stump 0 directly against the skin. For example, a layer of orthopedic rubber can act as a skin pad 100. A layer of foam or elastomer foam is preferably used, which is provided with a textile fabric on the side facing away from the body when used, that is, the limb stump 0. For example, Fabrifoam® from Smith & Nephew can be used.

If an open-line elastomer foam is used, the skin overlay is 100 breathable, moisture can diffuse to the textile fabric, ie away from the skin in use. The skin patch 100 can also be made of a thermoplastic or silicone.

Due to the elasticity of the skin pad 100, this adapts optimally to the body contours, that is, the surface of the limb stump 1. Due to the slip resistance of the elastomer foam layer, a pre-fixation of the skin pad 100 can be achieved after covering the tubular prosthetic shoe 10.

The flexible shaft covering layer 101 is placed on the skin support 100 and in the edge area at the circumferential connecting seams 102, the skin covering 100 and the shaft covering layer 101 are sewn, glued or welded to one another. It is crucial that the space between the skin overlay 100 and the shaft covering layer 101 is formed. Tear-resistant, hard-wearing and water-repellent materials, preferably thermoplastic plastics such as polyamide, for example nylon, are suitable as the material for the flexible shaft covering layer 101. These can form the shaft covering layer 101 in the form of a fabric. In Fig. 1, the fabric of the shaft cover layer 101 is indicated with a check pattern. Instead of plastic fabrics or textiles made of plastic, the shaft cover layer 101 can also be formed from leather. The flexible shaft covering layer 101 and the skin covering 100 are cut to size, for example by means of a cutting pattern, to be selected such that both can be connected to one another in the edge region and the space can be formed.

A sewing of the skin patch 100 with the shaft covering layer 101 can be done with a suture material made of plastic, for example polyamide threads. The connection along the long sides L can also be achieved by sewing. However, it is also possible to weld the long sides L and also to connect the skin overlay 100 and the shaft covering layer 101 to one another to form the tubular prosthetic shoe 10 along the long sides L after rolling up. The layers of thermoplastic materials can be welded, for example, by means of ultrasonic welding.

After completion of the tubular prosthetic shoe 10, it is pulled from distal d in the direction proximal p over the limb stump 0, as indicated by way of example in FIG. 1 by means of an arrow. Materials that are as light as possible should be used for the skin overlay 100 and the shaft covering layer 101 so that the total weight of the prosthesis socket 1 remains as small as possible.

The prosthesis socket 1 is formed in addition to the tubular prosthetic shoe 10 by an outer shell 11 with a closure device 113 and a coupling 2 shown in FIG. 5. The outer shell 11 surrounds the prosthetic shoe 10 when ready for use. In FIG. 2, a cut of the outer shell 11 is shown as an example in the paper plane. The outer shell 11 has an outer shell surface 111 and two recesses 112 which come to rest on the arm stump 0 in the area of the elbow.

CH 712 953 A1 On the outer shell surface 11, pointing away from the plane of the paper, the closure device 113 is shown schematically. The shell outer surface 11 is in the finished assembled state of the prosthesis socket

I arranged on the side of the prosthetic shoe 10 facing away from the shaft covering layer 101. The closure device 113 here comprises tensioning means 1131 in the form of a plurality of ropes which can be tensioned between a closure 1133 and a plurality of holding means 1132. The closure device 113 or the closure 1133 can be selected in the form of the “Boa Closure Binding System”, which is commercially available.

The closure device 113 has the task of holding the outer shell 11 after rolling together along the arrows around the prosthetic shoe 10 in a desired position. The closure device 113 thus ensures the shape of the outer shell 11 and the fixation of the outer shell 11 to the tubular multi-walled prosthetic shoe 10. The outer shell 11 must be designed to be dimensionally stable in such a way that on the one hand the closure device 113 can be held and the tubular prosthetic shoe 10 is held on the limb stump 0 , so that the prosthetic shoe 10 is protected from shocks. Various plastics in pure or fiber-reinforced form, for example polyethylene or polypropylene in different densities, come into consideration as possible materials for the outer shell 11. A polypropylene layer reinforced with polypropylene fibers is preferably used, a material which is available under the trade name Curv® from Propex Fabrics and is used, for example, in the manufacture of suitcases. The outer shell 11 must be resistant and as light as possible.

However, the outer shell 11 must also be able to be rolled up in such a way that the outer shell 11 can be placed around the limb stump 0 with the prosthetic shoe 10 in place.

In production, a plate of the material is cut with scissors depending on the desired prosthesis socket size and placed over the prosthesis shoe 10 so that the outer shell 11 at least partially surrounds the prosthesis shoe 10 in the region of the limb stump 0.

This is shown in Fig. 3. The outer shell 11 is held surrounding the prosthetic shoe 10 by means of a closure device 113. Ropes 1131 starting from the closure 1133 as tensioning means 1131 are placed around the outer shell 11 and guided by hooks 1132 as holding means 1132. The locking device 113 is designed as a cable pulling device with corresponding cables 1131 and the hooks 1132. The use of other deflection elements would be possible here. The tension of the ropes 1131 can be varied by rotating the closure 1133, which means the seat of the outer shell

II can be varied. The outer shell 11 is placed in a first step with little play relative to the prosthetic shoe 10.

Before or after the attachment of the outer shell 11, a tube S is guided into the space between the skin pad 100 and the flexible shaft covering layer 101 from the distal shell opening 110. Here, the hose S penetrates the connecting seam 102 between the skin support 100 and the flexible shaft covering layer 101. As soon as the closure device 113 holds the outer shell 11 around the prosthetic shoe 10, a foam is injected into the intermediate space 12 through the hose S, here by means of a connected syringe applied.

A foam layer 12 is generated in the space 12 between the skin pad 100 and flexible shaft covering layer 101, which fills the space 12, whereby the tubular prosthetic shoe 10 is pressed from the outer shell 11 to the forearm stump 0.

As a material for creating the foam layer 12, a foamable plastic, forming a soft foam layer, is used, which hardens after a short period of time. A polyurethane foam is preferably used. The foam layer 12 must have sufficient flexibility so that no pressure points can occur during use or the occurrence is minimized. The hardness, density and the expansion factor of the foam for the foam layer 12 can be adjusted via the mixing ratio of the two components and optimized to customer requirements.

The prosthesis socket 1 is attached by foaming the foam layer 12 between the skin overlay 100 and the flexible sleeve covering layer 101 without any great technical effort, together with the outer shell 11, on the forearm stump 0 with maximum comfort and with little weight. By foaming, the prosthetic shoe 10 adapts optimally to the limb stump 0.

Here, a multicomponent mixture to form a polyurethane foam was filled into the syringe, the chemical foam-forming reaction being slowed down by adding an inhibitor, so that the polyaddition to form the foam takes place with a delay, so that the introduction pressure of the material into the intermediate space 12 is more controllable , The connecting seams 102 or the tubular prosthetic shoe 10 or the skin pad 100 are not completely airtight, so that the displaced air can escape from the intermediate space 12 without specially arranged outlets when foaming. Alternatively, an opening can be arranged in the tubular prosthetic shoe 10, which ensures a controlled escape of the air or excess foam.

The foam layer 12 forms when the material is introduced under pressure in all directions in the intermediate space 12. The prosthetic shoe 10 is clamped between the surface of the extremity stump 0 and the inner surface of the outer shell 11 until the prosthetic shoe 10 lies comfortably against the extremity stump 0 when foamed.

Due to its low weight and thermal insulation, the material is also suitable for fast movements in different surroundings and it ensures a precise and precise handling of the prosthesis socket 1

CH 712 953 A1. The resulting prosthesis socket 1 is considerably lighter than other silicone-comprising prosthesis sockets 1 which are adapted by an orthopedic technician according to the prior art.

It is possible that several injection points are provided for the injection of the foam into the intermediate space 12 and, for example, a further hose S 'ensures the injection of the foam. This is indicated by dashed lines in FIG. 3. The foam could thus be introduced into the intermediate space 12 at different points at the same time or at different times. If different foam materials or foam with different consistency is used, different sections of the foam layer 12 have different hardnesses, which may be desired.

In order to prevent undesired mixing of different foam materials, the intermediate space 12 can have several separate chambers, which is not shown. The foam in the separate chambers, which in each case reaches the chamber of the intermediate space 12 through a gating point, results in different degrees of hardness in the area of the different chambers.

After foaming, the at least one tube S is removed and the foam can harden completely. While the foaming process only takes minutes, it takes a few hours to fully harden the foam.

After completion and adaptation of the prosthesis socket 1 on the limb stump 0, as can be seen in FIG. 5, a coupling 2 can be attached to the distal shell opening 110 of the outer shell 11. The coupling 2 is preferably detachably fastened by means of connecting means 20 of the outer shell 11, which is indicated here by screws which can be screwed into the recesses 20 on the coupling 2. In the fastened state, the screws cross the wall of the outer shell 11 completely and protrude into the recesses on the coupling 2. The coupling 2, which is designed here in disk form, is therefore largely concealed in the rolled-up outer shell 11. However, it would also be possible to glue or weld the coupling 2 to an inner surface and / or the shell outer surface 111 of the outer shell 11, that is to say to fasten it integrally. Instead of the screws, other fastening options for fastening the coupling 2 to the outer shell 11 can be used, for example an elastic bracelet or an arm clip, wherein a plurality of pins can be inserted through the outer shell 11 into openings in the coupling 2, so that a stable connection can be formed.

An exoprosthesis 3, shown here in the form of a hand prosthesis 3, can be attached to the coupling 2. To fasten the hand prosthesis 3, the coupling 2 and hand prostheses 3 can be designed in different ways to match one another. Here, a schematically shown plug connection between the exoprosthesis 3 and the coupling 2 is shown. Coupling 2 and hand prosthesis 3 are preferably designed such that the hand prosthesis can be connected and disconnected easily and quickly with one hand.

The entire device from prosthesis shaft 1, coupling 2 and exoprosthesis 3 is referred to here as a prosthesis. A prosthesis wearer can use the prosthesis by fitting the prosthesis socket 1, securing a sufficient fit by means of the locking device 113 and then using the exoprosthesis 3 attached to the coupling 2.

The adjustment method or manufacturing method of a prosthesis socket 1 on a limb stump 0 can be described by the following steps.

Covering the tubular multi-walled prosthetic shoe 10, comprising a skin overlay 100 and a flexible shaft covering layer 101, which are connected to one another by means of connecting seams 102, forming an intermediate space 12, over the limb stump 0.

- Enveloping the cut outer shell 11 with the closure device 113, comprising clamping means 1131, holding means 1132 and the at least one closure 1133.

- Clamping the outer shell 11 or the inner diameter of the outer shell 11 around the prosthetic shoe 10.

- Foaming the intermediate space 12, the tube S being guided into the intermediate space 12 before or after the covering of the prosthetic shoe 10 or being arranged therein (glued or sewn in) with a suitable foam material.

- Remove the hose S from the prosthetic shoe 10 and harden the foam layer 12.

- Attachment of the coupling 2 to the outer shell 11 by means of the connecting means 20 in the form of screws or adhesive.

After the foam layer 12 has been foamed and hardened, the foamed prosthetic shoe 10 and the outer shell 11 are removed from the forearm stump 0 before the coupling 2 is fastened, which is also possible with the prosthetic shoe 10 and outer shell 11 in place. The prosthesis socket 1 is thus produced.

To tighten the prosthesis socket 1, the user pulls the tubular foam-filled prosthetic shoe 10 over the limb stump 0. Then the outer shell 11 is placed around the foam-filled prosthetic shoe 10 by the prosthesis shoe 10 in the interior of the approximately conical outer shell 11 from proximal to distal is introduced. The closure device 113 is then adjusted such that a secure and comfortable fit of the prosthesis socket 1 on the limb stump 0 is achieved.

It is also possible to pull the prosthetic shoe 10 together with the surrounding outer shell 11 over the limb stump 0 and then simply to close it with the closure device 113.

CH 712 953 A1 The closure device 113 shown here consists of a cable pull mechanism consisting of tensioning means 1131 and holding means 1132 with a closure device 113 in the form of a coil and enables maximum wearing comfort and a precisely adjustable adjustment with only one hand movement. The holding means 1132, for example in the form of hooks or eyelets, are fastened to the outer surface 111 of the outer shell 11 by means of rivets or adhesive, so that the forces acting through the tensioning means 1131 can be absorbed.

As an alternative or in addition, buckle systems, Velcro fasteners or rubber expanders, which enable the optimal hold and avoid pressure points, can be attached to the outer shell 11 as a closure device 113.

In a simplified variant, the closure device 113 can be designed in the form of Velcro fasteners, which can be designed to completely enclose and hook the outer shell surface 111 of the outer shell 11. However, it would also be possible to arrange holding means 1132 in the form of Velcro tape adhesives with loops or barbs on the outer surface 111 of the shell, which can be connected to suitable Velcro tapes with barbs or loops (fleece tape), whereby an adjustable mounting of the outer shell 11 around the tubular prosthetic shoe 10 can be reached ,

As shown in Fig. 6, the outer shell 11 may have recessed longitudinal slots 114 which are distributed on the peripheral surface. The longitudinal slots 114 run from the proximal end of the outer shell in the direction of the distal end of the outer shell 11, wherein they do not run entirely to the distal shell opening 110 or to the coupling 2, but end beforehand. A longitudinally slotted plastic tube can be used in the manufacture as the outer shell 11. The arrangement of the closure device 113 can take place as explained above. The longitudinal slots 114 can be used to reduce the diameter of the outer shell 11 and thus adapt and fasten the prosthetic shoe 10, which cannot be seen here.

Alternatively, the outer shell 11 can be designed as a lattice formwork made of plastic, which comprises a plurality of lattice struts and free spaces. Such a lattice formwork 11 made of plastic is also known as a bionic lattice structure 11 and is able to surround the tubular prosthetic shoe 10 and hold it on a forearm stump 0.

Reference symbol list [0045]

Extremity stump / forearm stump

Prosthetic socket tubular prosthetic shoe

100 skin patch

101 flexible shaft cover layer

102 connecting seams

103 filling opening

outer shell

110 distal cup opening

111 shell outer surface

112 recesses

113 closure device

1131 tensioning devices / ropes

1132 holding means / hook

1133 closure

114 longitudinal slots

Gap / foam layer

Coupling for exoprosthesis

Connection means of the coupling

CH 712 953 A1

Exoprosthesis / prosthetic hand

S tubing p proximal d distal

Claims (14)

claims 1. A method for producing a prosthesis shaft (1) for attachment to an extremity stump (0), characterized by the steps: - Covering a tubular multi-walled prosthetic shoe (10), comprising a skin overlay (100) and a flexible shaft covering layer (101), which are connected to one another by means of connecting seams (102) to form an intermediate space (12), over the limb stump (0) - Enveloping the prosthetic shoe (10) with a cut outer shell (11), with a locking device (113) arranged on a shell outer surface (111) with clamping means (1131) and then tensioning the outer shell (11) or the inner diameter of the outer shell (11) around the prosthetic shoe (10) before - An intermediate space (12) between the skin overlay (100) and flexible shaft covering layer (101) is foamed with a foam material, whereby a foam layer (12) is formed and the final - Hardening the foam layer (12). 2. The method for producing a prosthesis shaft (1) according to claim 1, wherein the foam layer (12) by injecting a foamable plastic material from distal (d) into the intermediate space (12) with a tube (S), at least one connecting seam (102) traversing , and the tube (S) is removed or disconnected after the injection. 3. prosthesis socket (1) for an exoprosthesis (3) for attachment to an extremity stump (0), characterized in that the prosthesis socket (1) has a tubular, multi-walled prosthesis shoe (10) with a skin covering (100) and a shaft covering layer (101) , wherein an enclosed foam layer (12) lies between the skin cover (100) and the shaft covering layer (101) and the prosthesis socket (1) has an outer shell (11), the prosthesis shoe (10) at least partially on the side facing away from the skin cover (100) surrounding, wherein on a shell outer surface (111) of the outer shell (11), on the side facing away from the shaft envelope layer (101), a closure device (113) is attached, with which the inner diameter of the outer shell (11) can be varied and thus the fit of the Prosthetic shoe (10) on the limb stump (0) is adjustable. 4. prosthesis socket (1) according to claim 3, wherein the closure device (113) of holding means (1132) and clampable clamping means (1131), which are arranged on the shell outer surface (111), is formed adjustable by a closure (1133). 5. prosthesis socket (1) according to claim 4, wherein the holding means (1132) are hooks and / or eyelets and are fastened to the shell outer surface (111) by means of rivets or adhesive. 6. prosthesis socket (1) according to one of claims 4 or 5, wherein the tensioning means (1131) are ropes or cords. 7. prosthesis socket (1) according to one of claims 3 to 6, wherein the foam layer (12) is formed from a foamable plastic material, in particular from a polyurethane foam. 8. prosthesis socket (1) according to any one of claims 3 to 7, wherein the skin overlay (100) is formed from a material that is adaptable to the body contours of the extremity stump (0), in particular from an elastomer foam, silicone or a thermoplastic. 9. prosthesis socket (1) according to any one of claims 3 to 8, wherein the shaft cover layer (101) would be a plastic, a plastic fabric or textile fabric, preferably a layer made of thermoplastic material such as polyamide. 10. prosthesis socket (1) according to any one of claims 3 to 9, wherein the space (12) between the skin support (100) and flexible shaft covering layer (101) has a plurality of separate chambers. 11. A method for producing a prosthesis, with a prosthesis socket (1) according to one of claims 3 to 9, wherein after the hardening of the foam layer (12) a coupling (2) is attached to a distal shell opening (110) of the rolled-up outer shell (11) becomes. 12. The method for producing a prosthesis according to claim 10, wherein the coupling (2) is fastened by means of a screw connection comprising at least one connecting means (20) or by means of an adhesive or welded connection. 13. A prosthesis comprising a prosthesis socket (1) produced using the method according to one of claims 10 or 11. CH 712 953 A1 14. The prosthesis according to claim 12, wherein the coupling (2) is designed as a quick coupling, whereby the exoprosthesis (3) can be coupled and uncoupled with one hand without tools. CH 712 953 A1