EP3720393A1

EP3720393A1 - Prosthesis cover for a prosthesis, particularly for an artificial leg

Info

Publication number: EP3720393A1
Application number: EP18815153.4A
Authority: EP
Inventors: Andreas Radspieler
Original assignee: Romedis GmbH
Current assignee: Romedis GmbH
Priority date: 2017-12-05
Filing date: 2018-12-04
Publication date: 2020-10-14
Also published as: WO2019110543A1; CN111615373A; KR20200096592A; US20210000620A1; AU2018380746A1; DE102017128838A1; JP2021505343A; US11224525B2

Abstract

The invention relates to a prosthesis cover (100) having a closed cross-section with a first section (10), a second section (20) and a third section (30). The second section is positioned between said first and third sections in the longitudinal direction, and consists of a different material to the other two sections. Optionally, at least one first subsection (21) of the second section (20) can be, in part, folded, doubled over, raised, in pleats or in multiple layers.

Description

Besehreibung

Prosthesis cover for a prosthesis, in particular for a prosthesis

prosthetic leg

The present invention relates to a prosthesis cover having a closed cross section, i. H. to slip in or to get in with the extremity, such as the leg, according to claim 1.

From practice prosthesis coatings are known, which are bridged on the skin and in particular a joint of a patient.

An object of the present invention is to provide a

propose another denture cover.

The object of the invention is achieved by a

Prosthesis coating solved with the features of claim 1.

Here, the prosthesis coating along its

Longitudinal extension at least or exactly a first, second and third section or consists thereof. The second section is arranged in the longitudinal direction between the first and the third section and consists of a

Material with a greater modulus of elasticity than that

Materials of the first and / or the third section or comprises such a material.

The prosthesis cover serves to at least partially cover a limb prosthesis, in particular a leg prosthesis, in its intended use.

As intended, the prosthesis coating on the one hand on the Limb directly or through at least one

Material layer rest separately and on the other hand on a portion of the prosthesis, such as a cosmetic, directly or by at least one layer of material rest separately. The prosthesis cover can bridge, cover or enclose an artificial joint of the prosthesis.

For all subsequent versions, the use of the

Expression "may be" or "may have", etc. synonymous with "is preferably" or "preferably has", etc., and is intended to explain embodiments of the invention.

Embodiments of the invention may include one or more of the features mentioned above or below

respectively. The features mentioned herein may be in any combination subject of invention

Be embodiments unless the person skilled in a concrete combination recognizes as technically impossible.

Embodiments of the invention are also the subject of the subclaims and embodiments.

Whenever numerical words are mentioned herein, those skilled in the art will understand these as indicating a numerically lower limit. If this is not obvious to one skilled in the art

The expert therefore always reads "at least one" or "at least one" when stating "one" or "one", for example. This understanding is also encompassed by the present invention as the interpretation that a numerical word such as "a" may alternatively be meant as "exactly one" wherever technically possible for those skilled in the art. Both are from the and applies to all numerical terms used herein.

Whenever an embodiment is mentioned herein, it is an exemplary embodiment of the invention.

The statements "top" and "bottom" are here in doubt of the skilled person as absolute or relative space to

understand which relate to the orientation of the component in question during its normal use.

In some embodiments, the second portion has at least a first portion, which in

at least one state thereof is folded.

A prosthesis cover, as used herein, may also be a sealant, protective cover,

Vacuum (knee) bandage, cuff, prosthetic cuff,

Denture liner act. In any case, interchanging these terms leads to feature combinations that are also encompassed by the present invention.

In some embodiments, the denture cover is not a liner. He is optional not destined to be under one

Prosthesis shaft to be worn. It is intended to be worn over the prosthesis.

In some embodiments, the second portion has at least a first portion, which in

at least one state of the prosthesis cover is doubled. In other embodiments, the prosthesis cover and especially the second section is not duplicated

Part section and / or no bellows on.

A doubled subsection may be understood to mean a subsection in which the material containing the

Part of forms or is involved in its formation, at least in sections, two layers superimposed.

There are two layers of material from which the

Wall of the subsection consists of each other, which z. B. can be compared with a wrinkling. Unfolding of the subsection could result in a greater length (eg, in a direction transverse to the course of the fold) of the subsection. The duplication would be more or less

be discontinued and dissolve completely at the latest at a complete unfolding of the subsection. At full deployment, depending on the configuration, the subsection could only be more single-layered.

An example of a duplication is known from the accordion. In this case, the width of the region in which the layers of the material lie in folds on one another extends, but usually transversely to the longitudinal direction of the bellows.

According to the invention, the width in which the layers of the material lie in folds on one another runs completely, predominantly or essentially in the longitudinal direction of the partial region or of the prosthesis coating.

Under a position of the wall is in some embodiments, the entire thickness or thickness of, for example, textile, wall to understand. If you fold the wall, it lies in layers on each other. Layers, as used herein, are not to be confused with layers in some embodiments. A wall may have multiple layers, for. Legs Inner layer, which consists of a particularly skin-friendly material or has such, and a

particularly water or airtight material, which rests as an outer layer on the inner layer. The inner layer and the outer layer form completely

smoothed wall together only one layer. Only when one folds the wall so that - from the inside to the outside - an inner layer, an outer layer, a further outer layer, an inner layer and finally an outer layer join together, would one speak here of the wall being in two layers or doubled.

The above statements on the inner and outer layer may in some embodiments to the inner or

outside page to be transferred.

In some embodiments, the wall of the first, second and / or third section is made of exactly one layer.

In some embodiments, the second portion has at least a first portion, which in

at least one condition of the prosthesis cover is raised.

In some embodiments, the second portion has at least a first portion, which in

at least one state of the prosthesis cover is lamellar.

In some embodiments, the second portion has at least a first portion, which in at least one state of the prosthesis coating is completely or at least partially multi-layered.

In other embodiments, the second section has at least one longitudinal direction or at least one of

Longitudinal direction of the denture cover or the second

Section extending structure, which is - preferably alone or in itself - not folded, not duplicated, not thrown, not lamellar or not multilayered.

In some embodiments, all or some of the fins, multi-layered portions or doublings in the circumferential direction preferably do not extend in the longitudinal direction of the denture cover or the second portion.

In some embodiments, the first, second, and / or third portions of the prosthesis cover have an airtight seal

Material on or consists of this.

In some embodiments, the first portion and / or the second portion of the second portion of the prosthesis cover are not elastic.

In some embodiments, the first and / or third portions of the prosthesis overlay are elastic.

In some embodiments, "non-stretchable" or "non-elastic" means that the modulus of elasticity, abbreviated as modulus of elasticity, of the subsection in question is at least above 700 N / mm ² , preferably above 1000 N / mm ² , more preferably above 2000 N / mm ² , lies. In certain embodiments, "non-stretchable" or "non-elastic" means that elongation of the respective one

Subsection not more than 20%, preferably not more than 10%, preferably not more than 5%, more preferably not more than 2% of its length may be before the

Part section rips.

In some embodiments, the subject

Subsection or fibers thereof an elastic modulus such as nylon.

In certain embodiments, "stretchy" or "elastic" means the opposite of "nonextensible" or "nonelastic". A fabric or body is thus either elastic or elastic, or non-elastic or non-elastic.

In some embodiments, the second portion of the prosthesis overlay in at least a portion thereof, e.g. B. textile, raised structure on its inside, so on, the body extremity when wearing the

Prosthesis coating facing, side of the prosthesis cover or the second section.

In certain embodiments, the prosthetic cover or the second portion provides a material reserve in the

Longitudinal direction of the denture cover.

The material reserve can -. For example, when comparing the fully folded condition to the fully deployed condition - 10%, 20%, 30%, 40% or more. Thus, a prosthesis cover or its second section by unfolding, for example, to one of the above

Extend percentage values, or intermediate values thereof, by unfolding. The unfolding is preferably done not or essentially not elastic

Material properties back, but on the

Unfold z. B. of fins.

In some embodiments, the prosthesis cover has no closed end. In others he assigns

closed end on.

In some embodiments, the prosthesis cover has one or more elasticized fabrics, not others.

In some embodiments, not every element or portion of the prosthesis coating has elasticized substances.

In some embodiments, not every element or portion of the prosthesis coating has substances that have greater elastic stiffness in one direction than the other direction orthogonal to that one direction.

In some embodiments, the inner surface of the

Prosthesis coating not and / or not completely covered with a silicone elastomeric material, in particular not with a continuous, cured silicone elastomeric material.

In some embodiments, the second portion of the denture cover has no gel.

In some embodiments, the denture cover has no gel. In some embodiments, the prosthesis cover is not a hinge for coating, does not consist of a

elastic hose having a front side and a side opposite this flexing side, wherein the flexor side is at least partially formed in two layers, wherein the elastic tube is assembled from a front and a rear part, wherein the rear part forms the flexion side.

In some embodiments, the prosthesis coating does not have flat knitted areas on its flexor side, between which is knitted a tubular circular knit which is located in the flex area.

In some embodiments, the prosthesis cover is not a hinge bandage having a tubular body made of a resilient textile material with an insert in the

Beugeereich, wherein the elasticity of the insert is greater than that of the body.

In some embodiments, the prosthesis cover has no use with two areas of different

Elasticity, the individual elasticities are greater than that of the body.

In some embodiments, the prosthesis cover is not a fabric made of textile filaments, having a transverse wave structure formed on at least one side, which may be formed by or incorporated into a fabric

Deck structure lying elastic thread assembly, which is connected at predetermined intervals with the cover structure, is elastically biased and stabilized. In some embodiments, the prosthesis cover does not comprise a textile laminate having a resilient textile base and a plastic coating thereon that is thinner than the textile base and into which a perforation is made

Adjustment of an adapted elasticity of the textile laminate is introduced.

In some embodiments, the prosthesis cover has no populations. These include in particular applied, such as glued or sewn on patches, patches, pads, pillows.

In some embodiments, the prosthesis cover is not a compression bandage, particularly not to be worn on or over the healthy knee, especially when pressure is to be applied to the knee through a central portion of the prosthesis cover.

In some embodiments, the denture cover has no stroke orientations, in particular no sections with different stroke orientations.

In some embodiments, the prosthesis cover has no on its inside and / or outside

Projections on.

In some embodiments, the prosthesis coating has no on its inside and / or on its outside

Material intended to prevent movement of the prosthesis coating on the skin or over the skin. In some embodiments, the prosthesis cover has exactly three sections that are bonded together by bonds, sutures or otherwise to create a tubular structure.

In some embodiments, the first, second, and third portions are each circumferential. They all form a closed structure, one each

Through opening is formed, in which the prosthesis or the stump of the patient is introduced, or through which the stump is passed.

In some embodiments, the first, second and third sections are each circumferentially air impermeable.

In some embodiments, the prosthesis cover, the first, the second and / or the third section are each single-layered.

In some embodiments, the first and / or the second portion, but preferably not the third

Section, a material which shows the elongation of the

affected section in its circumferential direction or consist of it.

The extensibility of this portion in a direction perpendicular to the circumferential direction (ie in the longitudinal direction of the

Prosthesis coating), however, is lower, for example in the range 0% to 70% of the extensibility in the circumferential direction. Extensibility can be purely exemplary by means of corrugated or zigzag running fibers in the circumferential direction at z. B. non-wavy or zigzag running fibers can be achieved in the longitudinal direction. In some embodiments, the prosthesis cover has no curvature in its longitudinal direction.

In some embodiments, the prosthesis cover

Stiffening elements of a band-like substance on the prosthesis coating material or the

Prosthesis cover material sewn on, glued on or

otherwise be associated with him.

In some embodiments, the wall of the second portion -. B. in a fully unfolded state thereof - no variable radial thickness, especially their

Wall, especially on the anterior side, on.

In some embodiments, the prosthesis cover has no thickening in any of the sections other than the prosthesis cover

Use of different materials or thicknesses.

In some embodiments, the prosthetic cover or one or more portions are not made of a knitted, one-piece elastic tube.

In some embodiments, the prosthesis cover does not have a fabric section that is divided into two, in particular

perpendicular to each other, directions is stretchable.

In some embodiments, the prosthesis cover has no material that impedes movement, optionally neither on the inside nor on the outside.

In some embodiments, the prosthesis overlay does not have a plurality of annular protrusions. In some embodiments, the prosthesis coating has no longitudinal running at least on its outside

Projections, which, in each case distributed along a circumference of the prosthesis cover, extending thereon.

In some embodiments, the prosthesis coating, at least on its outer side no stabilizing element, in particular none of plastic on.

In some embodiments, the prosthesis cover does not comprise or consist of knitted fabric and / or knitted fabric.

In some embodiments, the prosthesis coating on the inner surface does not have a ring or a plurality of rings.

In some embodiments, no adhesive or adhesive fibers are integrated into the fabric, which protrude on the inside of the denture cover and for

provide additional support.

In some embodiments, the prosthesis cover is suitable and configured to apply a vacuum. For this, the material of the prosthesis coating, in particular the second portion, consist of an air-impermeable material, so that an applied vacuum at least over a certain period of time, for example over a few hours or days, can be maintained.

In some embodiments of the invention, at least one diameter and / or circumference (or the average Diameter or circumference) of the first portion and / or the second portion in a relaxed state or a non-use state of the denture cover smaller than a diameter and / or circumference (or the average

Diameter or circumference) of the second section. The

The diameter or circumference of the second section may optionally be between 5% and 20% larger than the diameter or circumference of the first and / or third sections.

Some or all embodiments according to the invention may have one, several or all of the advantages mentioned above and / or below.

It may be advantageous that the prosthesis cover, if it is applied bridging a joint in the patient, due to a reserve of material that the prosthesis cover the wearer z. B. offers on its anterior side by means of the second section, can provide a high level of comfort. Thus, depending on the design of the second section, there is no need for any forces or lesser forces than in the case of known prosthesis coatings, in bending the joint covered or bridged by means of the prosthesis covering, for example the artificial knee when walking.

A rubbing on the skin or on one under the

Prosthesis coating lying layer such. As a liner, caused by a stretching of the prosthesis coating on the

Elongated side of the joint followed by contracting of the denture cover over or on the prosthesis or the skin of the patient can also advantageously be prevented or reduced because the second section lying on the extensor side of the hinge is not elastic or only in

comparatively small extent is elastic. Due to the modulus of elasticity of the prosthesis coating, it can further be ensured that the prosthesis coating exerts no pressure on the underlying structures or tissue, at least in the region of the non-elastic or only comparatively small elastic portion, irrespective of flexion of the joint.

The present invention will be explained in the following with reference to the accompanying drawings, in which like reference numerals designate the same or similar components, by way of example. In the figures:

Fig. 1 shows a prosthesis coating according to the invention in a first embodiment;

Fig. 2 shows a prosthesis coating according to the invention in a second embodiment;

Fig. 2a shows the lower portion of the invention

Prosthesis coating of Figure 2 in a partial section.

Fig. 3 shows a prosthesis coating according to the invention in a third embodiment;

FIG. 4 shows a prosthesis coating according to the invention in a fourth embodiment; FIG.

Fig. Fig. 5 shows a prosthesis coating according to the invention in the fifth embodiment; and

Fig. 5a shows a section through the inventive

Prosthesis coating of FIG. 5 along a line BB of FIG. 5. Fig. 1 shows a prosthesis coating 100 according to the invention in a first embodiment from the side in a lighter

Perspective from above.

The prosthesis cover 100 has, or alternatively consists of, a first section 10, a second section 20, and a third section 30. Its longitudinal direction or longitudinal axis is denoted by L. It runs in the axial direction. Perpendicular to the longitudinal direction L runs the

Transverse direction or the radial direction.

The second section 20 lies between the first section 10 and the third section 30. In the example of the figures, the first section 10 and the third section 30 do not touch. As in FIG. 1, they are optionally in at least one radial layer, not in contact

together .

The second section 20 has a larger modulus of elasticity than the first section 10 and / or the third section 30.

Fig. 2 shows a prosthesis coating 100 according to the invention in a second embodiment.

In this case, the second section 20 is in a first

Part 21 thereof folded in a lamellar manner along its entire circumference. In FIG. 2, by way of example, eight lamellae can be seen, and every other number is likewise encompassed by the present invention.

The fins serve as a material reservoir. Will the

Prosthesis cover 100 via a joint, about the created artificial knee joint, and shows the patella or artificial patella of the wearer of the prosthesis cover 100 while referring to FIG. 2 to the left (with the popliteal fossa on the right side of the prosthesis cover 100 based on

Fig. 2), so the second section 20 with a larger modulus of elasticity compared to the sections 10 and / or 20 z. B. extend over the knee by unfolding.

The patient does not feel any pressure on the skin, which is due to the tension of an elastic material in the second

Section 20 would result. The second section 20

(compared to a smaller modulus of the first

Section 10 and / or third section 30) does not give rise to such pressure. Instead of building pressure, it simply extends in the longitudinal direction due to the lamellar structure provided for this purpose.

Fig. 2a shows the lower portion of the prosthesis coating 100 of the invention of FIG. 2 in a partial section A. The portion shown in Fig. 2a is shown in Fig. 2 with the

Reference symbol A denotes.

It can be seen that the material of the first

Partial section 21 of the second section 20, which is folded in slats, due to a duplication of each other. Although the material is still doubled in itself in the state of the prosthesis coating 100 shown in FIGS. 2 and 2a, it still has doublings, but its main extension lies (more or less) parallel to the longitudinal axis of the prosthesis coating 100, as shown in FIG However, at least not perpendicular to this embodiment. FIG. 3 shows a prosthesis coating 100 according to the invention in a third embodiment.

The prosthesis cover 100 differs from that of FIG. 2 by a second section 22.

The second section 22 connects the first section 10 to the third section 30. It can ensure that the distance between the first section 10 and the third section 30 (in the longitudinal direction L) does not exceed a maximum distance. He can also make sure that

Material reservoir of the second portion 20 is not already deployed when donning or applying the prosthesis cover 100 and the patient is no longer available in later Beugebewegungen.

Unlike the first section 21, whose length or visible length can be increased by unfolding, the second section 22 has no material reserve. His length is unchangeable, at least in the context of his

Elasticity.

In this case, the second portion 22 may be less elastic compared to the elasticity of the first portion 10 and / or the third portion 30. He can optionally not be elastic.

In Fig. 3, a second section 22 can be seen. However, two or more of such second sections 22 may be distributed over the circumference of the prosthesis overlay 100. The width of the second section 22 may also vary. In Fig. 3, the second portion 22 is shown comparatively narrow. Alternatively, it can also be wider than shown in FIG. 3. So he can z. B. up to 100 °, 120 °,

140 °, 160 ° or 180 ° of the circumference of the prosthesis cover 100 or more. The latter embodiment is shown in FIG.

Fig. 4 shows a prosthesis coating 100 according to the invention in a fourth embodiment.

The prosthesis cover 100 corresponds to that of FIG. 3, except that there is only a second partial section 22 which extends over 180 ° of the circumference of the denture cover 100

extends.

The first subsection 21 may, as in FIG. 4

shown by way of example, optionally with the second

Add section 22 to 360 °.

The first section 21 may optionally cover the circumference of the limb or prosthesis cover 100 at 360 °. The second subsection 22 can optionally rest against the first subsection 21 on its inside and / or outside.

As shown by way of example in FIG. 4, the first section 21 can cover or cover 180 ° of the circumference of the prosthesis cover 100. Alternatively, it can also be wider than shown in FIG. 4. So he can z. B. make up to 240 ° or more of the circumference of the prosthesis cover 100. In each embodiment of the invention, the first section 21 can cover between 40% and 70% of the circumference, more preferably a partial circumference which makes up between 55% and 65% of the circumference, most preferably 60% of the circumference.

The above percentages may optionally refer to the relaxed state of the denture cover 100, for example

Use, eg. B. in the shipping container, or on a use state, such as at the extremity refer.

5 shows a prosthesis coating 100 according to the invention in a fifth embodiment in a partial section.

Cut and unfolded is only the second section 20, but not the first section 10 and the third

Section 30. The view of the plane of the drawing of FIG. 5 shows the inside of the second section 20 which, in use of the prosthesis cover 100, bears against or in any case faces the skin of the patient.

Evident is a raised structure 25 which extends away from the inside of the second section 20 and in use of the prosthesis cover 100 radially inwardly thereof.

The structure 25 may preferably extend in a longitudinal direction of the prosthesis coating 100. It serves to one

To avoid perfect plan concerns of the second section 20 on the body of the patient. Favored by the

Distance that the structure 25 keeps open between the inside of the second portion 20 and the body of the patient (eg, the skin) may include an oppression between the inside of the second portion 20 and the body of the patient suitable vacuum devices without relevant

Niche formation can be generated.

5 a shows a section through the prosthesis coating 100 according to the invention of FIG. 5 along a line BB of FIG. 5.

LIST OF REFERENCE NUMBERS

100 denture cover

10 first section 20 second section

21 first section 22 second section 25 raised structure 30 third section

Claims

claims

1. prosthesis cover (100) with a closed

Cross-section, wherein the prosthesis cover (100) along its

Longitudinal extension at least a first portion (10), a second portion (20) and a third

Section (30), wherein the second portion (20) consists of a material or having a, which has a

greater elastic modulus than materials of the first section (10) and / or the third

Portion (30), and wherein the second portion (20) between the first portion (10) and the third portion (30) is arranged.

2. prosthesis cover (100) according to claim 1, wherein the second portion (20) in at least a first

Section (21) folded in sections, doubled, thrown, lamellar or multi-layered.

3. prosthesis cover (100) according to claim 1 or 2, wherein the first portion (10), the second portion (20) and / or the third portion (30) comprises an airtight material or consists thereof.

4. prosthesis cover (100) according to any one of the preceding claims, wherein the second portion (20) at least one in the longitudinal direction of the prosthesis cover (100) or the second portion (20) extending structure as second section (22) which is not folded, doubled, thrown, lamellar or multilayered.

5 prosthesis cover (100) according to any one of the preceding claims, wherein the first portion (21) and / or the second portion (22) are not elastic.

6 prosthesis cover (100) according to any one of the preceding claims, wherein the first portion (10) and / or the third portion (30) are elastic.

7 prosthesis cover (100) according to any one of the preceding claims, wherein the second portion (20) in at least one portion (21, 22) thereof a raised

Structure (25) has on its inside.