PROSTHETIC COVER

Abstract

The present disclosure relates to a tube-shaped cover for covering an amputation stump, wherein the cover has at least one open end for introduction of said amputation stump, wherein the cover comprises an elastic textile material in the shape of a tube; a friction increasing material arranged to be in contact with the amputation stump; and a moisture absorbing and/or moisture transferring material, preferably wherein the moisture absorbing and/or moisture transferring material is a moisture absorbing material. The present disclosure also relates to a kit comprising a cover according to the present disclosure and a sleeve configured to create a seal between an upper edge of a prosthetic socket and an amputation stump covered by said cover.

Claims

1. A cover for covering an amputation stump, wherein the cover is tube-shaped and has at least one open end for introduction of said amputation stump, wherein the cover comprises: an elastic textile material having a shape of a tube; a friction increasing material arranged to be in contact with the amputation stump; and a moisture absorbing and/or moisture transferring material, wherein the moisture absorbing and/or moisture transferring material is a moisture absorbing material; and a material impermeable to air.

2. (canceled)

3. The cover according to claim 1, wherein the cover has two open ends.

4. The cover according to claim 1, wherein the cover has one open end for introduction of said amputation stump and one closed end opposite the one open end.

5. The cover according to claim 1, wherein the elastic textile material, the moisture absorbing and/or moisture transferring material, the friction increasing material and the material impermeable to air are distributed between one, two, three or four layers forming the cover.

6. The cover according to claim 1, wherein two, three or four of the elastic textile material, the friction increasing material, the moisture absorbing and/or moisture transferring material and the material impermeable to air are incorporated in a same material.

7. The cover according to claim 1, wherein the friction increasing material is incorporated in the elastic textile material.

8. The cover according to claim 1, wherein the moisture absorbing and/or moisture transferring material is incorporated in the elastic textile material.

9. The cover according to claim 1, wherein the material impermeable to air is incorporated in the moisture absorbing and/or moisture transferring material, or wherein the moisture absorbing and/or moisture transferring material is a same material as the material impermeable to air.

10. The cover according to claim 1, wherein the elastic textile material is a textile, a fabric, a woven material, or a non-woven material.

11. The cover according to claim 1, further comprising an outer layer comprising the material impermeable to air covering the moisture absorbing and/or moisture transferring material layer.

12. The cover according to claim 1, wherein the material impermeable to air is a type of plastic.

13. The cover according to claim 1, wherein the cover is configured to be used together with a prosthetic socket, which is to be suspended to the amputation stump by a vacuum between the cover and the socket when the amputation stump is introduced into said cover.

14. The cover according to claim 4, wherein the moisture absorbing and/or moisture transferring material is arranged around the elastic textile material, wherein a thickness of the moisture absorbing material and/or moisture transferring material at the one closed end of the cover is thicker than a thickness of the moisture absorbing material at a remaining portion of the cover.

15. The cover according to claim 4, further comprising a cushioning material at the one closed end of the cover configured to moderate a load between the amputation stump and a prosthetic socket.

16. The cover according to claim 4, further comprising a threaded portion arranged at the one closed end of the cover, wherein the threaded portion is adapted for a fastening of: a pin configured to engage in a lock in a prosthetic socket, and/or a strap configured to guide the pin into the lock; or a strap configured to engage in the lock in the prosthetic socket.

17. The cover according to claim 4, wherein the cover further comprises: a strap arranged proximal to the closed end of said cover, wherein the strap is configured to guide an amputation stump covered by said cover into a prosthetic socket.

18. The cover according to claim 1, wherein a thickness of the cover is between 1 and 10 mm.

19. A kit comprising the cover according to claim 4, and a sleeve configured to create a seal between an upper edge of a prosthetic socket and an amputation stump covered by said cover.

20. The cover according to claim 10, wherein the elastic textile material is a silicone woven material made of silicone threads.

21. The cover according to claim 12, wherein the material impermeable to air is a hydrophilic copolymer.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0185] By way of example, embodiments of the present teaching will now be described with reference to the accompanying drawings, in which:

[0186] FIG. 1a shows a lateral cross section of one embodiment of a cover according to the present teaching comprising an elastic textile material layer;

[0187] FIG. 1b shows a lateral cross section of one embodiment of a cover according to the present teaching comprising an elastic textile material layer and an outer layer of an air-tight material;

[0188] FIG. 1c shows a lateral cross section of one embodiment of a cover according to the present teaching comprising a friction increasing layer, a layer of an elastic textile material and an air-tight material layer;

[0189] FIG. 1d shows a lateral cross section of one embodiment of a cover according to the present teaching comprising a friction increasing layer, a layer of an elastic textile material, a moisture absorbing and/or transferring layer and an air-tight material layer;

[0190] FIG. 2a shows a lateral cross section of one embodiment of a cover according to the present teaching having a thicker right hand side than the left hand side of a moisture absorbing and/or transferring material;

[0191] FIG. 2b shows a lateral cross section of one embodiment of a cover according to the present teaching having a thicker bottom layer of a moisture absorbing and/or transferring material;

[0192] FIG. 2c-d show a lateral cross section of embodiments of a cover according to the present teaching having a cushion formed of a cushioning material 28 at the closed end 22 of the cover.

[0193] FIG. 3a-3e show exemplary arrangements of a friction increasing material in different embodiments of a cover according to the present teaching;

[0194] FIG. 4 shows an amputation stump covered with a cover introduced and fitted into a hard socket of a prosthesis, such as a prosthetic leg;

[0195] FIG. 5 shows an alternative embodiment of the prosthetic cover shaped as a sleeve;

[0196] FIG. 6 shows a cover comprising a threaded insert for the connection of a pin;

[0197] and

[0198] FIG. 7a-7d show exemplary arrangements of a seal member on a cover according to the present teaching.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

[0199] The present teaching relates to a cover, also referred to as a prosthetic cover, a liner or a prosthetic liner, having a tube-like shape and comprising an elastic textile material, a friction increasing material arranged to be in contact with an amputation stump, and a moisture absorbing and/or moisture transferring material. Preferably, the moisture absorbing and/or moisture transferring material is a moisture absorbing material. The cover may also include a material impermeable to air. The amputation stump is also referred to herein as the stump or residual limb.

[0200] In the following, the cover is referred to by the reference numbers 10a-d, 20a-d, 30a-e, 40, 50, 60 and 70a-70d.

[0201] In short, the disclosed prosthetic cover enables the amputee to wear a prosthesis with a decreased risk of problems such as blemishes and other painful conditions. Further, the cover disclosed herein will cause compression of the soft parts of the amputation stump, which favours the distribution of the pressure and load from the prosthesis. In addition, the cover decreases the relative humidity formed between the stump and the socket of the prosthesis. These advantages will facilitate the amputee to use his or her prosthesis during all awaken hours after only a couple of months training. The cover is compatible with prostheses having variable fitting mechanisms, such as a vacuum system, a suction system, a lanyard system or a shuttle lock system.

[0202] The cover may comprise an elastic textile material 13, a moisture absorbing and/or moisture transferring material 16, a friction increasing material 14 and an air-tight material 17, distributed between one, two, three or four layers forming the cover 10a-d.

[0203] Embodiments of the cover according to the present teaching will now be described in relation to the accompanying figures.

[0204] Preferably, in the embodiments presented herein, the moisture absorbing and/or moisture transferring material is a material that is moisture absorbing or a material that is moisture absorbing and moisture transferring.

[0205] The tube-shaped covers 10a, 10b, 10c, 10d shown in FIGS. 1a-1d all comprise an open end 11 and a closed end 12 opposite to the open end 11. During use, an amputation stump is inserted into the open end 11.

[0206] A tube-shaped cover as shown in FIGS. 1a-1d is for use as covers that covers the amputation stump beneath (i.e. inside) the socket of a prosthesis, i.e. as liners.

[0207] A tube-shaped cover as shown in FIGS. 1a-1d may have the same width or diameter throughout its entire length.

[0208] A tube-shaped cover as shown in FIGS. 1a-1d may have different diameters along its length. For example, the open end 11 may have a width or diameter larger than the diameter close to the closed end 12 of the cover 10a, 10b, 10c, 10d. Thus, a tube-shaped cover as shown in FIGS. 1a-1d may have a shape similar to a truncated cone. Preferably, the proximal end, i.e. the open end 11, of the cover 10a, 10b, 10c, 10d may be wider (have larger diameter) than the distal end, i.e. the closed end 12, of the cover 10a, 10b, 10c, 10d. Furthermore, the closed end 12 of the cover 10a, 10b, 10c, 10d may have a substantially rounded shape, such as to fit the shape of an amputation stump. The skilled person realizes that the exact dimensions of the cover 10a, 10b, 10c, 10d preferably are individually adjusted to fit the amputation stump.

[0209] FIG. 1a shows a lateral cross section of a tube-shaped prosthetic cover 10a comprising an elastic textile material 13 which is also a moisture absorbing and/or a moisture transferring material. In this embodiment, the elastic textile material 13 provides a cover having enough friction to keep the cover tightly arranged on the amputation stump, i.e. the elastic textile material 13 is also a friction increasing material. Since the elastic textile material 13 compresses the stump, the elastic textile material 13 may also have friction increasing properties. The cover 10a shown in FIG. 1a may further comprise a material impermeable to air.

[0210] In some embodiments, the elastic textile material 13 is a compressive material, or a stretch-limited material.

[0211] In some embodiments, the elastic textile material 13 is also be a material impermeable to air.

[0212] In one embodiment (not shown), the cover comprises an elastic textile material 13, which is also a moisture absorbing and/or a moisture transferring material, and a separate friction increasing material 14.

[0213] In one embodiment (not shown), the cover comprises an elastic textile material 13, which is also a moisture absorbing and/or a moisture transferring material as well as a material impermeable to air, and a separate friction increasing material 14.

[0214] The friction increasing material 14 is arranged on an interior surface 15 of the cover 10c.

[0215] The friction increasing material 14 may cover the entire interior surface 15 of the cover.

[0216] The friction increasing material 14 may cover only a part or parts of the interior surface 15 of the cover.

[0217] The friction increasing material may have different geometrical forms, such as stripes, rings, circles, rectangles, stars, ovals etc.

[0218] The friction increasing material 14 may be evenly spread on the entire interior surface 15.

[0219] The friction increasing material 14 may be unevenly spread on the entire interior surface 15, such as being more densely spread on certain parts of the interior surface 15, or being present only in certain parts of the interior surface 15.

[0220] Commonly, the friction increasing material 14 is arranged as dots or stripes/circumferential rings on the interior surface 15 of the cover.

[0221] The cover 10b shown in FIG. 1b comprises an elastic textile material 13 which is also a moisture absorbing and/or a moisture transferring material, and a layer of an air-tight material 17, also referred to herein as a material impermeable to air. In this embodiment, the elastic textile material 13 provides a cover having enough friction to keep the cover tightly arranged on the amputation stump, i.e. the elastic textile material 13 is also a friction increasing material. The elastic properties of the elastic textile material 13 provides friction between the skin and the cover. In some embodiments, the elastic textile material 13 is a compressive material, or a stretch-limited material. The air-tight material 17 (i.e. the material impermeable to air) covers the elastic textile material 13.

[0222] Preferably, the air-tight material 17 is a type of plastic. Preferred plastics are hydrophilic copolymers, such as for instance polyether based thermoplastic polyurethane (TPU). One example of a thermoplastic polyurethane is “Respire” since these materials are impermeable to air and permeable to moisture.

[0223] The air-tight material 17 may be selected from the group consisting of a thermoplastic elastomer, a thermoset elastomer, and mixtures thereof.

[0224] Moreover, the air-tight material 17 may be a silicone, a urethane, a block copolymer and/or a block copolymer and mineral oil gel composition. The block copolymer may be a styrene-ethylene/butylene-styrene block copolymer, a styrene-ethylene/propylene block copolymer and/or a styrene isoprene/butadiene block copolymer.

[0225] The air-tight material 17 may have such properties that moisture may permeate through the air-tight material 17, while air may not permeate the air-tight material 17. Hence, moisture can be transported out from the inside of the cover 10b thus decreasing the humidity inside the prosthetic socket, while air cannot penetrate through the layer of the air-tight material 17.

[0226] The use of an air-tight material 17 is preferable when the prosthesis is to be fitted using a vacuum or suction suspension system. When the cover 10 has been rolled or threaded onto the amputation stump, the stump is inserted and fitted into the socket of the prosthesis. Subsequently, by using a mechanical or electrical pump, often placed on a side of the prosthesis, air is removed to form vacuum between the cover 10 and the socket. Alternatively, the stump provided with the cover 10 is inserted and fitted into a suction suspension system, and suction suspension holds the prosthesis securely attached to the stump. The air-tight material 17 achieves the suction suspension. The air-tight material 17 thus aids in preventing air from penetrating into the socket and disrupting the vacuum/suction formed therein, which would lead to the prosthesis not being tightly attached to the amputation stump.

[0227] In FIG. 1c, a cover 10c comprising a layer of a friction increasing material 14 is shown. The cover 10c further comprises an elastic textile material 13, which is also a moisture absorbing and/or a moisture transferring material and a layer of an air-tight material 17.

[0228] The friction increasing material 14 is arranged on an interior surface 15 of the cover 10c.

[0229] The friction increasing material 14 may cover the entire interior surface 15 of the cover.

[0230] The friction increasing material 14 may cover only a part or parts of the interior surface 15 of the cover.

[0231] The friction increasing material may have different geometrical forms, such as stripes, rings, circles, rectangles, stars, ovals etc.

[0232] The friction increasing material 14 may be evenly spread on the entire interior surface 15.

[0233] The friction increasing material 14 may be unevenly spread on the entire interior surface 15, such as being more densely spread on certain parts of the interior surface 15, or being present only in certain parts of the interior surface 15.

[0234] Preferably, the friction increasing material is present as dots or stripes/circumferential rings on the interior surface 15 of the cover.

[0235] In one embodiment (not shown), the cover comprises an elastic textile material 13 and a separate layer of a moisture absorbing and/or moisture transferring material 16. In this embodiment, the elastic textile material 13 provides a cover having enough friction to keep the cover tightly arranged on the amputation stump, i.e. the elastic textile material 13 is also a friction increasing material. In some embodiments, the elastic textile material 13 is a compressive material, or a stretch-limited material. The elastic textile material 13 may also be an air-tight material and/or the moisture absorbing and/or moisture transferring material 16 may also be an air-tight material.

[0236] In FIG. 1d, a cover 10d according to the present teaching is shown. The cover 10d comprises a layer of an elastic textile material 13. Further, it comprises a layer of a friction increasing material 14 arranged on an interior surface 15 of the cover 10d and a separate layer of a moisture absorbing and/or moisture transferring material 16 as well as a layer of an air-tight material 17. Details of the different layers are as explained above.

[0237] The cover 10 shown in FIG. 1d has a thickness T, which is between 1 and 6 mm. Preferably, the thickness T is between 2 and 5 mm.

[0238] In one embodiment (not shown), the cover comprises a layer of an elastic textile material 13. Further, it comprises a layer of a friction increasing material 14 arranged on an interior surface 15 of the cover 10d and a separate layer in which a moisture absorbing and/or moisture transferring material as well as a layer of an air-tight material are incorporated. Thus, in this embodiment the moisture absorbing and/or moisture transferring material 16 and the material impermeable to air 17 are incorporated in the same material. Details of the different layers are as explained above. The cover has a thickness T, which is between 1 and 6 mm. Preferably, the thickness T is between 2 and 5 mm.

[0239] In one embodiment (not shown), the cover comprises a layer in which an elastic textile material and a friction increasing material are incorporated. The cover further has separate layer of a moisture absorbing and/or moisture transferring material as well as a layer of an air-tight material. Thus, in this embodiment the elastic textile material and the friction increasing material are incorporated in the same material. Details of the different layers are as explained above. The cover has a thickness T, which is between 1 and 6 mm. Preferably, the thickness T is between 2 and 5 mm.

[0240] In one embodiment (not shown), the cover comprises an elastic textile material 13, a layer of a friction increasing material 14 arranged on an interior surface 15 of the cover 10 and a separate layer of a moisture absorbing and/or moisture transferring material 16. The cover has a thickness T, which is between 1 and 6 mm. Preferably, the thickness T is between 2 and 5 mm. Details of the different layers are as explained above.

[0241] In one embodiment (not shown), the cover comprises a layer of an elastic textile material. The elastic textile material is also a friction increasing material. The cover further has separate layer of a moisture absorbing and/or moisture transferring material as well as a layer of an air-tight material. Details of the different layers are as explained above. The cover has a thickness T, which is between 1 and 6 mm. Preferably, the thickness T is between 2 and 5 mm.

[0242] In one embodiment (not shown), the cover comprises an elastic textile material 13, a separate layer of a moisture absorbing and/or moisture transferring material 16 and a layer of an air-tight material 17. Details of the different layers are as explained above.

[0243] The elastic textile material 13 of a cover 10, 20, 30 as disclosed herein has a controlled elasticity, which forms a cover with compressive properties. This in turn enables the compression of soft parts of the amputation stump. When the soft parts are compressed, the load of the prosthetic socket is more evenly distributed around the amputation limb, which decreases the risk of abrasions and wounds. It will also make it overall more comfortable to wear the prosthesis.

[0244] The elastic textile material 13 preferably has an elasticity of between 10% and 600%, such as 50% to 550%, such as 100% to 500%, such as 150% to 450%, such as 200% to 425%, and most preferred 300% to 400%.

[0245] Preferably, the elastic textile material 13 is acrylic, alpaca, angora, bamboo, cotton, elastane, lycra, hemp, modal, nylon, a polyester (such as Coolmax), and/or a wool (such as Merino Wool or cashmere wool).

[0246] Further, the elastic textile material 13 may be a textile, a fabric, a woven material, such as a silicone woven material made of silicone threads, or non-woven material.

[0247] The elastic textile material 13 may be air permeable and moisture transferring.

[0248] The friction increasing material 14 may be selected from a silicone, a rubber, a gel or polyurethane (PUR).

[0249] The friction increasing material 14 is configured to increase the friction between the skin of the stump and a cover as disclosed herein. Hence, the friction increasing material 14 is arranged to be in contact with the skin surface of the amputation stump. This is achieved either by arranging the friction increasing material 14 on the interior surface 15 of the cover as disclosed herein (e.g. as seen in FIGS. 1c and 1d) or by incorporating the friction increasing material 14 into the elastic textile material 13 (e.g. as shown in FIGS. 1a and 1b). Friction between the skin of the amputation stump and the cover 10a, 10b, 10c, 10d causes the cover 10a, 10b, 10c, 10d to stay in place during use. When the cover 10a, 10b, 10c, 10d stays put, the risk of sores caused by the socket of the prosthesis is minimized. As described above, the friction increasing material may be incorporated into the moisture absorbing and/or transferring material 16 or into the material impermeable to air.

[0250] The moisture absorbing and/or moisture transferring material 16 may alternatively be arranged as a separate layer 16 as shown in FIG. 1d. The moisture absorbing and/or transferring material 16 absorbs and removes moisture from the skin surface of the amputation stump, and thus decreases the relative humidity in the environment between the stump and the socket and on the skin surface of the amputation stump.

[0251] The layer of the moisture absorbing and/or moisture transferring material 16 has a thickness of between 1 and 4 mm, preferably between 2 and 3 mm.

[0252] The layer 16 should be thick enough to protect skin of the amputation limb and thin enough to avoid too high temperatures and humidity within the prosthetic member. For instance, a thicker layer 16, such as 1 to 6 mm, enables more absorption of moisture and thus a more cooling effect.

[0253] The layer 16 has to be thick enough to protect the stump from the hard socket.

[0254] The layer 16 further has to be thin enough to fit inside the prosthesis.

[0255] Materials such as non-woven materials, wool, silica gels, textiles, fabrics, woven materials, hydrogels, super absorbents or a combination thereof may be used as the moisture absorbing and/or transferring material 16.

[0256] The use of these materials causes the relative humidity inside the prosthetic socket during use to decrease to levels as low as 50-60%. When using prosthetic covers known in the art beneath (i.e. inside) a prosthetic socket, the relative humidity often quickly, such as within only 15-20 minutes, increases to levels as high as 100%. Thus, in particularly preferred embodiments, the cover comprises a moisture absorbing material.

[0257] High relative humidity is an effect of the tight fitting between the stump and socket, and also the materials used in conventional covers for the stump known in the art. For instance, many conventional covers comprise a compressive material that is not moisture absorbing, resulting in that moisture is not absorbed properly from the stump, which causes the relative humidity adjacent to the skin to increase. Other covers are made of silicone provided with textile on an internal side facing the stump to decrease friction since the friction between the silicone and the skin is too high. Nor this solution absorbs enough moisture to make sure that the relative humidity at the skin surface is kept sufficiently low.

[0258] Human skin is sensitive to moisture, and hence, the resistance of the skin is significantly reduced at high humidity levels. However, at a relative humidity of 50-60%, the skin is much more resistant. An environment having a relative humidity of 100% is also experienced as very hot and uncomfortable, while levels at 50-60% are not perceived as such.

[0259] By decreasing the relative humidity in the environment which the skin is exposed to inside the socket, the risk of the user getting abrasions and wounds from the wear from the prosthetic socket is decreased. In addition, the experience for the user is more comfortable since the covers 10a-d, 20a-d, 30a-e, 40, 50, 60, 70a-d disclosed herein decrease the relative humidity inside the socket.

[0260] These effects may facilitate a recently amputated user to be able to use his/her prosthesis for longer periods sooner than when using covers presently available on the market. Further, decreasing the risk of formation of wounds on the stump is also important for users having additional conditions. For example, a user also suffering from diabetes are more prone to bacterial infections caused by wounds formed on the amputation stump.

[0261] The covers of the present disclosure surprisingly are covers which manage to maintain the level of relative humidity at the surface of the stump at 50-60%. In addition, and at the same time comprise an air-tight material 17 such that a secure attachment between the stump and a prosthetic socket can be achieved.

[0262] Preferably, the moisture absorbing material is a super absorbent.

[0263] A silica gel which absorbs moisture may also be used as the moisture absorbing material.

[0264] If a natural material is more preferred, wool is preferable since it both transports and absorbs moisture.

[0265] The super absorbent may be a cross-linked acrylate copolymer, partially neutralised to its sodium salt.

[0266] The moisture absorbing and/or moisture transferring material 16 in FIG. 1d is distributed as an evenly thick layer around the cover 10.

[0267] The layer of the moisture absorbing and/or moisture transferring material 16 may also be arranged having different thicknesses in different areas of the cover 10. Different parts of the stump have different structure and hardness. For instance, a part of the stump which is hard due to the presence of bone tends to benefit from a thicker layer of the moisture absorbing and/or moisture transferring material 16, while parts of the stump being softer do not need the same thickness of the layer 16. Thus, a cover according to the present teaching may be custom made to fit each individual amputation stump.

[0268] In one embodiment the moisture absorbing and/or moisture transferring material 16 is arranged such that the thickness of the moisture absorbing material 16 at the closed end 12 of the cover 10 is thicker than the thickness of the moisture absorbing material 16 at the rest of the cover 10. If the end of the stump is sensitive to load, the thicker layer of the moisture absorbing and/or transferring material 16 at the closed end 12 of the cover 10 protects and unburdens the stump.

[0269] FIGS. 2a-d show lateral cross sections of covers 20a-d with exemplary arrangements of the moisture absorbing and/or transferring material 16 and with exemplary arrangements of a cushioning material 28.

[0270] For simplicity, in FIGS. 2a-d only the moisture absorbing and/or transferring material 16 is shown. However, the skilled person realises that the covers 20a-d may comprise different combinations of different layers as explained in relation to FIG. 1 or in the text above.

[0271] The covers 20a-d may comprise an elastic textile material 13, which is also a moisture absorbing and/or a moisture transferring material as explained in relation to FIG. 1a or in the text above.

[0272] Alternatively, the covers 20a-d may comprise an elastic textile material 13, which is also a moisture absorbing and/or a moisture transferring material, and a friction increasing material 14 as explained above.

[0273] Alternatively, the covers 20a-d may comprise an elastic textile material 13, which is also a moisture absorbing and/or a moisture transferring material, and a layer of an air-tight material 17 as explained in relation to FIG. 1b. If the cover 20a-d is used together with a prosthesis using a vacuum fastening system, it is important to prohibit air from entering in between the cover and the socket of the prosthesis. When the cover 20a-d comprises the air-tight material 17, the risk of air penetrating in between the cover and the socket is reduced and the prosthesis is securely fastened thanks to the cover 20a-d.

[0274] Alternatively, the covers 20a-d may comprise an elastic textile material 13, which is also a moisture absorbing and/or a moisture transferring material, a layer of an air-tight material 17 and a friction increasing material 14 as explained in relation to FIG. 1c.

[0275] Alternatively, the covers 20a-d may comprise a layer of an elastic textile material 13, a layer of a friction increasing material 14 arranged on an interior surface 15 of the cover 20a-d and a separate layer of a moisture absorbing and/or moisture transferring material 16. Details of the different layers are as explained above.

[0276] Alternatively, the covers 20a-d may comprise an elastic textile material 13 and a separate layer of a moisture absorbing and/or moisture transferring material 16. Details of the different layers are as explained above.

[0277] Alternatively, the covers 20a-d may comprise an elastic textile material 13, a separate layer of a moisture absorbing and/or moisture transferring material 16 and a layer of an air-tight material 17. Details of the different layers are as explained above.

[0278] Alternatively, the covers 20a-d may comprise an elastic textile material 13, a separate layer of a moisture absorbing and/or moisture transferring material 16, and a separate friction increasing material 14 and a layer of an air-tight material 17 as explained in relation to FIG. 1d.

[0279] Alternatively, the covers 20a-d comprise an elastic textile material 13, a moisture absorbing and/or moisture transferring material 16, a friction increasing material 14 and an air-tight material 17, distributed between one, two, three or four layers forming the cover 20a-d as explained above.

[0280] FIG. 2a shows a lateral cross section of a cover 20a with an exemplary arrangement of the moisture absorbing and/or transferring material 16. The cover 20a has an open end 21 and a closed end 22. The moisture absorbing and/or transferring material 16 in FIG. 2a is thicker at the right side than at the left side of the cover 20a.

[0281] FIG. 2b presents another embodiment of a cover 20b, having an open end 21 and a closed end 22 opposite said open end 21. The cover 20b further comprises the moisture absorbing and/or transferring material 16 provided as a thicker layer at the closed end 22 of the cover 20b. The thicker layer of the moisture absorbing and/or transferring material 16 moderates the load and pressure between the residual limb and the prosthesis. This provides a more comfortable wear for the amputee and reduces the risk of abrasions on the end of the amputation stump.

[0282] The cover may be provided with a cushion formed of a cushioning material 28 at the closed end 22 of the cover 20 (FIGS. 2c and 2d). Similar to the thicker layer of the moisture absorbing and/or transferring material 16 in FIG. 2b, the cushion moderates the load between the residual limb and the prosthesis. This provides a more comfortable wear for the amputee and reduces the risk of abrasions on the end of the amputation stump. In addition, patients having very sensitive stumps or being recently amputated benefit from the cushioning material 28 since it relieves stress and provides comfort for the stump.

[0283] The cushioning material 28 may be for instance the same material as the moisture absorbing and/or moisture transferring material 16. In such case, the cushion may be arranged as a thicker layer of the moisture absorbing and/or moisture transferring material 16 at the closed end 22 of the cover 20 (corresponding to an embodiment resembling the embodiment shown in FIG. 2b).

[0284] The cushioning material 28 may be a silicone, a gel, a rubber or any other pressure relieving materials.

[0285] The cushioning material 28 may be arranged at the closed end 22 and on the inside surface of the cover 20c (FIG. 2c).

[0286] Alternatively, the cushioning material 28 may be arranged at the closed end 22 and on the outside surface of the cover 20d (FIG. 2d).

[0287] FIGS. 3a-e show lateral cross sections of covers 30a-e with exemplary arrangements of the friction increasing material 14.

[0288] As shown in FIGS. 3a-3e, the friction increasing material 14 may be arranged as stripes, dots, rings figures and/or circumferential rings on the inside of the cover.

[0289] The friction increasing material 14 may be arranged as a combination of these different geometrical shapes or any other arrangement causing the friction increasing material 14 to be in contact with the skin of the amputation stump.

[0290] In FIG. 3a, the friction increasing material 14 is arranged as dots distributed on the interior surface of the cover 30a.

[0291] For simplicity, in FIGS. 3a-d only the moisture absorbing and/or transferring material 16 is shown.

[0292] The friction increasing material 14 may be arranged as lines or stripes as shown in the cover 30b in FIG. 3b.

[0293] The cover 30c shown in FIG. 3c comprises the friction increasing material 14 in the shape of circles.

[0294] The cover 30d in FIG. 3d comprises the friction increasing material 14 in the form of star-shaped figures.

[0295] The skilled person realizes that the friction increasing material 14 can have any geometrical shape.

[0296] The cover 30e in FIG. 3e comprises the friction increasing material 14 in the form of circumferential rings on the inside of the cover 30e.

[0297] In addition, these different arrangements may be combined. For instance, in the covers 30a, 30b, 30c and 30d a circumferential ring of the friction increasing material 14 may be provided on the interior surface close to the open end 31 of the cover 30a, 30b, 30c and 30d (not shown).

[0298] The friction increasing material 14 may also be incorporated in the elastic textile material 13, forming a joint layer in contact with the skin of the stump.

[0299] The friction increasing material 14 may also be incorporated in the moisture absorbing and/or a moisture transferring material 16, forming a joint layer in contact with the skin of the stump.

[0300] The friction increasing material 14 may also be incorporated in the air-tight material 17, forming a joint layer in contact with the skin of the stump.

[0301] The covers 30a-e may comprise an elastic textile material 13, which is also a moisture absorbing and/or a moisture transferring material as explained in relation to FIG. 1a.

[0302] Alternatively, the covers 30a-e may comprise an elastic textile material 13, which is also a moisture absorbing and/or a moisture transferring material, and a friction increasing material 14 as explained above.

[0303] Alternatively, the covers 30a-e may comprise an elastic textile material 13, which is also a moisture absorbing and/or a moisture transferring material, and a layer of an air-tight material 17 as explained in relation to FIG. 1b.

[0304] Alternatively, the covers 30a-e may comprise an elastic textile material 13, which is also a moisture absorbing and/or a moisture transferring material, a layer of an air-tight material 17 and a friction increasing material 14 as explained in relation to FIG. 1c.

[0305] Alternatively, the covers 30a-e may comprise a layer of an elastic textile material 13, a layer of a friction increasing material 14 arranged on an interior surface 15 of the cover 20a and a separate layer of a moisture absorbing and/or moisture transferring material 16. Details of the different layers are as explained above.

[0306] Alternatively, the covers 30a-e may comprise an elastic textile material 13 and a separate layer of a moisture absorbing and/or moisture transferring material 16. Details of the different layers are as explained above.

[0307] Alternatively, the covers 30a-e may comprise an elastic textile material 13, a separate layer of a moisture absorbing and/or moisture transferring material 16 and a layer of an air-tight material 17. Details of the different layers are as explained above.

[0308] Alternatively, the covers 30a-e may comprise an elastic textile material 13, a separate layer of a moisture absorbing and/or moisture transferring material 16, and a separate friction increasing material 14 and a layer of an air-tight material 17 as explained in relation to FIG. 1d.

[0309] Alternatively, the covers 30a-e comprise an elastic textile material 13, a moisture absorbing and/or moisture transferring material 16, a friction increasing material 14 and an air-tight material 17, distributed between one, two, three or four layers forming the cover 30a-e.

[0310] Independent of the number and nature of the layers 13, 14, 16 and 17 present in a cover according to the present teaching, the exemplary arrangements of the moisture absorbing and/or transferring material 26 and with exemplary arrangements of a cushioning material 28 as described above may be combined with one or more of the exemplary arrangements of the friction increasing material 14 as shown in FIGS. 3a-e and described above.

[0311] Hence, the cover according to the present teaching preferably comprises an elastic textile material 13, a friction increasing material 14, a moisture absorbing and/or moisture transferring material 16 and an air-tight material 17 present in a number of layers which together forms the cover 10, 20, 30, 40, 50, 60, 70.

[0312] For instance, the elastic textile material 12 may also be a friction increasing material 14, and the moisture absorbing and/or moisture transferring material 16 may also be an air-tight material 17.

[0313] FIG. 4 shows how an amputation stump 1 covered with a cover 40 according to the present teaching is arranged in a prosthetic socket 2 of a prosthetic device 5, which e.g. may be a prosthetic leg.

[0314] The socket 2 is hard and the cover 40 thus decreases the wear between the skin surface of the amputation stump 1 and an internal surface of the hard socket 2.

[0315] The arrangement shown in FIG. 4 further comprises a sleeve 3 covering an upper edge 4 of the socket 2. The sleeve 3 is used to form an additional seal to prevent air from penetrating into the socket 2. A sleeve 3 is not always used but is common when using lower leg prostheses.

[0316] The cover 40 in FIG. 4 is any cover as disclosed herein. Thus, the cover 40 may consist of one to three of the layers 13, 14, 16 and 17 as described above. Further, the cover 40 may comprise any of the exemplary arrangements of the moisture absorbing and/or transferring material 26. Moreover, the cover 40 may comprise any exemplary arrangements of a cushioning material 28 as described above. Finally, the cover 40 may comprise one or more of the exemplary arrangements of the friction increasing material 14 as described above.

[0317] A cover according to the present teaching may also be in the form of a sleeve 50. A lateral cross section of one embodiment of such a sleeve 50 is shown in FIG. 5. The sleeve (cover) 50 in FIG. 5 comprises two open ends 51, 51 opposite to each other. Thus, the sleeve 50 may be threaded onto an amputation stump and enclose for instance a knee or an elbow.

[0318] The sleeve 50 may have different diameters along its length. For example, one open end 51 may have a width or diameter smaller than the diameter of the other open end 51 of the sleeve. Thus, the sleeve 50 may have a shape similar to a truncated cone. Preferably, the proximal end, i.e. the end intended to be closest to the torso of the patient, of the sleeve 50 is wider (has larger diameter) than the distal end, i.e. the end intended to be closest to the end of the amputation stump, of the sleeve 50. The skilled person realizes that the exact dimensions of the sleeve 50 preferably are individually adjusted to fit the amputation stump.

[0319] The sleeve 50 may be used to cover the upper edge 4 of the socket 2, as shown in FIG. 4. If the cover is used together with a prosthesis using a vacuum fastening system or a suction suspension system, the sleeve 50 can prevent air from entering into the socket of the prosthesis.

[0320] In one embodiment, the sleeve 50 comprises a layer of an elastic textile material 13, which also is a moisture absorbing and/or transferring material. The sleeve 50 may comprise the same materials as the covers 10a-d and in all the different arrangements disclosed herein.

[0321] For simplicity, in FIG. 5 only the elastic textile material 13 is shown. However, the skilled person realises that the sleeve 50 may comprise different combinations of different layers as explained in relation to FIG. 1.

[0322] The sleeve 50 may comprise an elastic textile material 13, which is also a moisture absorbing and/or a moisture transferring material as explained in relation to FIG. 1a.

[0323] Alternatively, the sleeve 50 may comprise an elastic textile material 13, which is also a moisture absorbing and/or a moisture transferring material, and a friction increasing material 14 as explained above.

[0324] Alternatively, the sleeve 50 may comprise an elastic textile material 13, which is also a moisture absorbing and/or a moisture transferring material, and a layer of an air-tight material 17 as explained in relation to FIG. 1b.

[0325] Alternatively, the sleeve 50 may comprise an elastic textile material 13, which is also a moisture absorbing and/or a moisture transferring material, a layer of an air-tight material 17 and a friction increasing material 14 as explained in relation to FIG. 1c.

[0326] Alternatively, the sleeve 50 may comprise a layer of an elastic textile material 13, a layer of a friction increasing material 14 arranged on an interior surface 15 of the sleeve 50 and a separate layer of a moisture absorbing and/or moisture transferring material 16. Details of the different layers are as explained above.

[0327] Alternatively, the sleeve 50 may comprise an elastic textile material 13 and a separate layer of a moisture absorbing and/or moisture transferring material 16. Details of the different layers are as explained above.

[0328] Alternatively, the sleeve 50 may comprise an elastic textile material 13, a separate layer of a moisture absorbing and/or moisture transferring material 16 and a layer of an air-tight material 17. Details of the different layers are as explained above.

[0329] Alternatively, the sleeve 50 may comprise an elastic textile material 13, a separate layer of a moisture absorbing and/or moisture transferring material 16, and a separate friction increasing material 14 and a layer of an air-tight material 17 as explained in relation to FIG. 1d.

[0330] Generally, the friction increasing material is located on the inside surface, i.e. the surface of the sleeve intended to be in contact with the upper edge of a socket.

[0331] The friction increasing material 14 and the elastic textile material 13 may be incorporated in a common layer.

[0332] The friction increasing material 14 and the moisture absorbing and/or moisture transferring material 16 may be incorporated in a common layer.

[0333] Alternatively, the sleeve 50 comprises an elastic textile material 13, a moisture absorbing and/or moisture transferring material 16, a friction increasing material 14 and an air-tight material 17, distributed between one, two, three or four layers forming the sleeve 50.

[0334] Independent of the number and nature of the layers 13, 14, 16 and 17 present in a sleeve 50 according to the present teaching, the exemplary arrangements of the moisture absorbing and/or transferring material 26 and with exemplary arrangements of a cushioning material 28 as described above may be combined with one or more of the exemplary arrangements of the friction increasing material 14 as shown in FIGS. 3a-e and described above.

[0335] The friction increasing material 14 may be more densely spread on the interior surface 15 at the end parts of the sleeve 50.

[0336] In one embodiment, the sleeve 50 comprises a friction increasing material 14 covering the internal upper and lower edges of the sleeve 50 (not shown) and further comprises an outer layer of an air-tight material 17 (not shown).

[0337] As mentioned above, the covers disclosed herein may be used together with a prosthesis that is fastened to the amputation stump using various kinds of fastening systems.

[0338] The cover may be used together with a vacuum or suction suspension system. In such case, the amputation stump covered with a cover comprising an air-tight material according to the present teaching is introduced into a socket of a prosthetic member and vacuum is established in the socket causing the amputation stump to be firmly connected to the prosthesis.

[0339] Vacuum may be accomplished either passively or actively. Passive vacuum is achieved if the amputation stump fits perfectly into the prosthetic socket. When the stump is introduced into the socket, air is removed from the socket through a one-way exhaust air valve and vacuum is formed inside the socket. A cover according to the present teaching is rolled onto an amputation stump and is inserted into the socket of a prosthesis. When the amputation stump covered with the cover is inserted into the socket and when the body weight of the amputee is applied as the amputee stands up, air contained in the socket permeates through the one-way exhaust valve. A suction is created within the socket, which provides an even adhesion between the cover and the socket.

[0340] If vacuum is to be formed actively, the prosthetic socket comprises some type of air pump, such as a mechanical pump which may be operated manually, or an electric pump.

[0341] Vacuum improves the adherence between the socket and the amputation stump, which provides a comfortable fit. A cover comprising an air-tight material according to the present teaching is especially suitable for such use.

[0342] A sleeve 3 may also be used in a vacuum fastening system, which creates a seal around the upper edge 4 of the socket 2, which further reduces the risk of air penetrating in between the cover and the prosthetic socket.

[0343] Alternatively, the cover may be used with a so called lanyard system. In such case, the cover comprises a first strap near and proximal to the top open end 11, 21, 31, 41, 51, 61, 71 of the cover, and a second strap at the bottom closed end 12, 22, 32, 42, 62, 72 of the cover. The cover is fitted onto the amputation stump. Further, the socket of the prosthesis in the lanyard system comprises a first slit through which the first strap may be introduced from the inside of the socket to the outside. The first strap also comprises a loop, which is thus moved through the slit and is arranged on the outside of the socket once the first strap has been pulled through the first slit. The second strap comprises at a portion close to the cover a first part of a hook-and-loop system and at a second end a second part of a hook-and-loop system. The bottom of the socket comprises a second slit where the second strap is inserted from the inside to the outside of the socket. When the second strap has been pulled through the second slit, it is threaded through the loop of the first strap. Subsequently, the two ends of the second strap may attach to each other whereupon the two parts of the hook-and-loop system engage with each other. The prosthesis has now been fastened to the amputation stump and the cover protects the stump from abrasions and too high humidity during wear.

[0344] A lanyard system may also be arranged with a single strap in the bottom closed end of the cover, which is pulled through a hole in the bottom of the prosthetic socket and subsequently securely fastened in for instance a loop, ring or hook on the outer side of the prosthetic socket. The strap may be threaded through the loop, ring or hook and secured to itself by any suitable fastening means.

[0345] The cover may also be used together with a pin and lock system, such as a shuttle lock system. Such a cover 60 is shown in FIG. 6. The cover 60 comprises an open end 61 and a female threaded portion 63 arranged at a closed end 62 of the cover 60. A pin 64 comprises a male threaded portion 65. The pin is thus removably connectable to the cover 60. The cover 60 is mounted onto an amputation stump and the male threaded portion 65 of the pin 64 is screwed into the female threaded portion 63. The amputation stump covered with the cover 60 is then inserted into a prosthetic socket having a lock in its bottom (not shown). The pin 64 engages with the lock to secure the fastening of the cover 60 in the prosthetic socket (not shown).

[0346] Optionally, a strap may be attached to the pin. The strap is intended to guide the pin into the shuttle lock comprised in the socket of the prosthesis (not shown).

[0347] As exemplified above, a cover according to the present teaching is compatible with different prosthesis suspensions, such as e.g. the lanyard system, a pin and lock system, a vacuum system or a suction system.

[0348] If a cover according to the present teaching is used together with a prosthesis using a vacuum fastening system, it is important to prohibit air from entering into the socket of the prosthesis. This may be accomplished by a sleeve as explained above and/or a seal member located on the outside of the cover.

[0349] In FIG. 7a-7d, a cross section of the cover 70 is shown. The cover 70 according to the present teaching is shown together with a seal member 73. The cover 70 comprises an open end 71 and a closed end 72. The seal member 73 comprises an annular flange 74 extending from the cover 70. In some embodiments the seal member 73 comprises more than one flange 74, such as two, three or four flanges.

[0350] The seal member 73 may be made from any material suitable for sealing, such as silicone, rubber or other materials impermeable to air, such as a polymer or a co-polymer.

[0351] The flange 74 may be of variating width and thickness. The width of the seal member 73 is indicated by the dashed lines in FIGS. 7a-7d. The width may be 2 to 15 cm, such as 5 to 10 cm, preferably approximately 7 cm.

[0352] The seal member 73 may be a separate part, which is threaded onto the cover 70.

[0353] Alternatively, the seal member 73 is a part of the cover 70 attached to the outside of the cover 70.

[0354] The seal member 73 shown in FIGS. 7a-7d is used to enable the formation of vacuum between the prosthetic socket and the cover 70 and to create a seal between the cover 70 and a prosthetic socket. The flange 74 aids the formation of vacuum between the cover 70 and the socket and also prevents air from entering in between the cover 70 and the socket during use.

[0355] If the seal member 73 is part of the cover 70, the cover 70 with the seal member 73 is rolled onto the amputation stump. Subsequently, the stump wearing the cover 70 with the seal member 73 is pushed into the prosthetic socket. The flange 74 aids the formation of vacuum between the cover 70 and the socket and also prevents air from entering in between the cover 70 and the socket during use.

[0356] If a separate seal member 73 is used, the cover 70 is rolled onto the amputation stump. Then, the seal member 73 is threaded onto the outside of the cover 70. Subsequently, the stump wearing the cover 70 and the seal member 73 is pushed into the prosthetic socket. The flange 74 aids the formation of vacuum between the cover 70 and the socket and also prevents air from entering in between the cover 70 and the socket during use.

Specific Embodiments

[0357] Embodiment A: The cover comprises four layers. The first layer is intended to have direct contact with an amputation stump and comprises a friction increasing material. The second layer covers the first layer and comprises an elastic textile material. The third layer comprises a moisture absorbing and moisture transferring material and covers the second layer. The fourth layer comprises a material impermeable to air and covers the third layer.

[0358] The friction increasing material is preferably chosen from silicone, rubber and a soft plastic.

[0359] The elastic textile material is preferably chosen from silicone, rubber and polyurethane.

[0360] The moisture absorbing and moisture transferring material is preferably chosen from wool, cotton and super absorbent material.

[0361] The material impermeable to air is preferably a solid hydrophilic plastic.

[0362] Embodiment B: The cover is as described for Embodiment A, further having a seal with 1 to 3 flanges, preferably 1 flange.

[0363] Embodiment C: The cover comprises four layers. The first layer is intended to have direct contact with an amputation stump and comprises a friction increasing material. The second layer covers the first layer and comprises an elastic textile material. The third layer comprises a moisture absorbing material and covers the second layer. The fourth layer comprises a material impermeable to air and covers the third layer.

[0364] The friction increasing material is preferably chosen from silicone, rubber and a soft plastic.

[0365] The elastic textile material is preferably chosen from silicone, rubber and polyurethane.

[0366] The moisture absorbing and moisture transferring material is preferably chosen from wool, cotton and super absorbent material.

[0367] The material impermeable to air is preferably a solid hydrophilic plastic.

[0368] Embodiment D: The cover is as described for Embodiment C, further having a seal with 1 to 3 flanges, preferably 1 flange.

[0369] Embodiment E: The cover comprises three layers. The first layer is intended to have direct contact with an amputation stump and comprises a friction increasing material. The second layer covers the first layer and comprises an elastic textile material. The third layer comprises a moisture absorbing and moisture transferring material and a material impermeable to air and covers the second layer.

[0370] The friction increasing material is preferably chosen from silicone, rubber and a soft plastic.

[0371] The elastic textile material is preferably chosen from silicone, rubber and polyurethane.

[0372] The moisture absorbing and moisture transferring material is preferably chosen from wool, cotton and super absorbent material.

[0373] The material impermeable to air is preferably a solid hydrophilic plastic.

[0374] Embodiment F: The cover is as described for Embodiment E, further having a seal with 1 to 3 flanges, preferably 1 flange.

[0375] Embodiment G: The cover comprises three layers. The first layer is intended to have direct contact with an amputation stump and comprises a friction increasing material. The second layer covers the first layer and comprises an elastic textile material. The third layer comprises a moisture absorbing material and a material impermeable to air and covers the second layer.

[0376] The friction increasing material is preferably chosen from silicone, rubber and a soft plastic.

[0377] The elastic textile material is preferably chosen from silicone, rubber and polyurethane.

[0378] The moisture absorbing and moisture transferring material is preferably chosen from wool, cotton and super absorbent material.

[0379] The material impermeable to air is preferably a solid hydrophilic plastic.

[0380] Embodiment H: The cover is as described for Embodiment G, further having a seal with 1 to 3 flanges, preferably 1 flange.

[0381] Embodiment I: The cover comprises two layers. The first layer is intended to have direct contact with an amputation stump and comprises a friction increasing material and an elastic textile material. The second layer covers the first layer and comprises a moisture absorbing and moisture transferring material and a material impermeable to air.

[0382] The friction increasing material is preferably chosen from silicone, rubber and a soft plastic.

[0383] The elastic textile material is preferably chosen from silicone, rubber and polyurethane.

[0384] The moisture absorbing and moisture transferring material is preferably chosen from wool, cotton and super absorbent material.

[0385] The material impermeable to air is preferably a solid hydrophilic plastic.

[0386] Embodiment J: The cover is as described for Embodiment I, further having a seal with 1 to 3 flanges, preferably 1 flange.

[0387] Embodiment K: The cover comprises two layers. The first layer is intended to have direct contact with an amputation stump and comprises a friction increasing material and an elastic textile material. The second layer covers the first layer and comprises a moisture absorbing material and a material impermeable to air.

[0388] The friction increasing material is preferably chosen from silicone, rubber and a soft plastic.

[0389] The elastic textile material is preferably chosen from silicone, rubber and polyurethane.

[0390] The moisture absorbing and moisture transferring material is preferably chosen from wool, cotton and super absorbent material.

[0391] The material impermeable to air is preferably a solid hydrophilic plastic.

[0392] Embodiment L: The cover is as described for Embodiment K, further having a seal with 1 to 3 flanges, preferably 1 flange.

REFERENCE SIGNS

[0393] 1 amputation stump [0394] 2 prosthetic socket [0395] 3, 50 sleeve [0396] 4 upper edge of a prosthetic socket [0397] 10a-d, 20a-d, 30a-3, 40, 50, 60, 70 cover [0398] 11, 21, 31, 51, 61, 71 open end [0399] 12, 22, 32, 52, 62, 72 closed end [0400] 13 elastic textile material [0401] 14 friction increasing material [0402] 15 interior surface of the cover [0403] 16 moisture absorbing and/or moisture transferring material [0404] 17 air-tight material [0405] 28 cushioning material [0406] 63 female threaded portion [0407] 64 pin [0408] 65 male threaded portion [0409] 73 seal member [0410] 74 flange on seal member