Abstract
A prosthetic suspension sleeve with a fabric section of 5-60 degrees that allows for a greater comfort for the wearer. The use of polymeric material is easier on the skin while also enhancing the function of the sleeve by retaining its location due to the grip on the skin and exterior socket wall and sealing the socket and wearer's skin to allow a vacuum to form or be created within the socket. The sleeve generally comprises an internal gel or silicone layer and an outer fabric layer, both of which are pre-flexed to a 5 to 60-degree bend at about a midsection of the sleeve, and an internal fabric layer which is located throughout the midsection of the suspension sleeve depending on the placement of a prosthetic socket. The prosthetic suspension sleeve may also be a straight sleeve with fabric reinforcement. The internal fabric layer may alternatively further comprise an internal layer of sprayed silicone.
Claims
1. A fabric reinforced suspension sleeve comprising: an open proximal end; an open distal end; an exterior fabric layer; an inner cushion layer further comprising a midsection bent at an angle between 5 and 60 degrees; and a fabric reinforcement layer attached to the inner cushion layer at the midsection bent to the angle of the inner cushion layer.
2. The fabric reinforced suspension sleeve of claim 1 wherein the inner cushion layer is silicone.
3. The fabric reinforced suspension sleeve of claim 1 wherein the inner cushion layer is a thermoplastic elastomer.
4. The fabric reinforced suspension sleeve of claim 1 wherein the inner cushion layer is an elastomer comprising a styrene triblock copolymer.
5. The fabric reinforced suspension sleeve of claim 1 further comprising a proximal circumferential band and a distal circumferential band incorporated on the fabric reinforcement layer.
6. The fabric reinforced suspension sleeve of claim 1 further comprising a plurality of longitudinal retention strips incorporated on the fabric reinforcement layer.
7. The fabric reinforced suspension sleeve of claim 6 further comprising a proximal circumferential band and a distal circumferential band incorporated on the fabric reinforcement layer.
8. The fabric reinforced suspension sleeve of claim 1 wherein the fabric reinforcement layer further comprises an inner elastomer layer.
9. The fabric reinforced suspension sleeve of claim 1 wherein the fabric reinforcement layer has a length that is 25% of a total length of the fabric reinforced suspension sleeve.
10. The fabric reinforced suspension sleeve of claim 1 wherein the fabric reinforcement layer has a length of at least three inches.
11. A fabric reinforced suspension sleeve comprising: an open proximal end; an open distal end; an exterior fabric layer; an inner cushion layer further comprising a midsection; and a fabric reinforcement layer attached to the inner cushion layer at the midsection.
12. The fabric reinforced suspension sleeve of claim 11 wherein the inner cushion layer is silicone.
13. The fabric reinforced suspension sleeve of claim 11 wherein the inner cushion layer is a thermoplastic elastomer.
14. The fabric reinforced suspension sleeve of claim 11 wherein the inner cushion layer is an elastomer comprising a styrene triblock copolymer.
15. The fabric reinforced suspension sleeve of claim 11 further comprising a proximal circumferential band and a distal circumferential band incorporated on the fabric reinforcement layer.
16. The fabric reinforced suspension sleeve of claim 11 further comprising a plurality of longitudinal retention strips incorporated on the fabric reinforcement layer.
17. The fabric reinforced suspension sleeve of claim 16 further comprising a proximal circumferential band and a distal circumferential band incorporated on the fabric reinforcement layer.
18. The fabric reinforced suspension sleeve of claim 11 wherein the fabric reinforcement layer further comprises an inner elastomer layer.
19. The fabric reinforced suspension sleeve of claim 11 wherein the fabric reinforcement layer has a length that is 25% of a total length of the fabric reinforced suspension sleeve.
20. The fabric reinforced suspension sleeve of claim 11 wherein the fabric reinforcement layer has a length of at least three inches.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0018] For a more complete understanding of the present disclosure and its advantages, reference is now made to the following descriptions, taken in conjunction with the accompanying drawings, in which:
[0019] FIG. 1 is a side perspective of a limb system comprising a limb, cushion liner, and socket without a sleeve;
[0020] FIG. 2 is a cross-sectional view showing the sleeve of the present invention;
[0021] FIG. 3 is a cross-sectional view showing use of the sleeve of the present invention with the limb system shown in FIG. 1;
[0022] FIG. 4 is a perspective view of the sleeve of the present invention highlighting the pre-flexed bend;
[0023] FIG. 5 is a top perspective view of the present invention;
[0024] FIG. 6 is a cross-sectional view of the present invention along line J-J of FIG. 5;
[0025] FIG. 7 is a cross-sectional view of an alternative embodiment of the present invention as a straight sleeve;
[0026] FIG. 8 is a cross-sectional view of an alternative embodiment of the present invention utilizing longitudinal retention strips and circumferential bands;
[0027] FIG. 9 is a cross-sectional view of an alternative embodiment of the present invention utilizing circumferential bands;
[0028] FIG. 10 is a cross-sectional view of an alternative embodiment of the present invention utilizing longitudinal retention strips;
[0029] FIG. 11A is a perspective view of an alternative embodiment of the present invention;
[0030] FIG. 11B is a cross-sectional view of FIG. 11A along line M-M;
[0031] FIG. 12A is a perspective view of an alternative embodiment of the present invention; and
[0032] FIG. 12B is a cross-sectional view of FIG. 12A along line O-O.
[0033] Similar reference numerals refer to similar parts throughout the several views of the drawings.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0034] The following description is of the best mode presently contemplated for carrying out the invention. This description is not to be taken in a limiting sense, but is made merely for the purpose of describing one or more preferred embodiments of the invention. The scope of the invention should be determined with reference to the claims.
[0035] As shown in FIG. 1, prosthetic users first insert their residual limb 500 into a cushion liner 100 after which the user inserts the residual limb and liner 100 into a socket 200 having a brim 36. Liner 100 comprises an open proximal end and a closed distal end as well as an external fabric layer and an internal gel or silicone layer. Socket 200 is made of a hard plastic or carbon fiber resin and comprises a patellar opening, a pair of raised ears, and a rear opening. Prior art methods then involved adding a suspension sleeve over the socket/liner/limb combination in order to create an airtight seal.
[0036] FIGS. 2 through 6 depict the pre-flexed suspension sleeve 300 of the present invention. The suspension sleeve 300 is an open-ended truncated cone with an outer fabric layer 20 and an inner cushion layer 22. Inner cushion layer 22 may be made of silicone or a thermoplastic elastomer such as a styrene triblock copolymer or other elastomer known in the art. The suspension sleeve 300 further has a proximal end 24, a distal end 26, and a midsection 28 which runs from about ? of the distance from the proximal end 24 to about a ? of the distance from the distal end 26, as shown in FIG. 4. The midsection 28 includes a bend 30 which ranges from 5 to 60 degrees from where the pre-flexed suspension sleeve 300 would lie if it was completely vertical. The pre-flexed suspension sleeve 300 of the present invention preferably has a bend 30 angle between 20 and 40 degrees. When under a vacuum, pre-flexed suspension sleeve 300 further forms a neck 32 which tapers towards the open proximal end 24. The inner cushion layer 22 further comprises an interior fabric reinforcement layer 34. Preferably, the interior fabric reinforcement layer 34 is located throughout the midsection 28 and may also be pre-flexed to the angle of the pre-flexed suspension sleeve 300. Alternatively, the interior fabric reinforcement layer 34 is placed below the bend 30 as that is normally where the brim 36 of the socket 200 is located when in use and therefore the area of the pre-flexed suspension sleeve 300 most susceptible to frictional forces or damage but the interior fabric reinforcement layer 34 may be located on the inner cushion layer 22 anywhere that it is likely that it will come into contact with the socket 200 once donned. For example, it may be beneficial to have the interior fabric reinforcement layer 34 located medially placed below the bend 30 for those amputees who have longer residual limbs below the knee. Alternatively, it may be beneficial to have the fabric reinforcement layer extend further above the bend 30 for those amputees who desire longer sleeves in order to extend the amount of gel above the interior fabric reinforcement layer 34 to gain an increased sense of security that the sleeve will maintain suction. In addition, the interior fabric reinforcement layer 34 may further comprise an inner elastomer layer 38. The inner elastomer 38 is preferably uniformly thick, more preferably a thickness level equivalent to individual droplets of the material use, so that the interior fabric reinforcement layer 34 can both maintain frictional contact with the socket 200 as well as with the residual limb 500. The inner elastomer layer 38 is preferably silicone but may be any elastomer or adhesive that can be applied to a uniform thickness on the interior fabric reinforcement layer 34. The inner elastomer layer 38 may be applied by spraying, rolling, brushing, blotting, or any other method that allows for uniform application. The uniform application of the inner elastomer layer 38 is important so as to maintain the stretch characteristics of the outer fabric layer 20.
[0037] The interior fabric reinforcement layer 34 of the pre-flexed suspension sleeve 300 can be attached through many methods including, but not limited to, adhesive, molding, solvent bonding, embedding and any other method known in the art. This attachment allows for a continuous polymeric material for the inner cushion layer 22 with a reinforcement that is protecting the interior surface from the socket brim 36. This reinforcement may be made of a similar or different material as the outer fabric layer 20. The fabric reinforcement layer 34 preferably has a length that is 25% of the total length of the pre-flexed suspension sleeve 300 but may be at long as the entire length of the pre-flexed suspension sleeve 300 or as short as three inches in length.
[0038] Alternatively, as shown in FIG. 7, the present invention can be a straight sleeve 600 as opposed pre-bent. The straight sleeve 600 has a slight taper from the proximal end 24 to the distal end 26. The fabric reinforcement layer 34 is preferably placed around a midsection 28 as in previous embodiments. The straight sleeve 600 has an outer fabric layer 20 and an inner cushion layer 22 having the same qualities as in previous embodiments.
[0039] An alternative embodiment is shown in FIG. 8. Here, the fabric reinforcement layer 34 is further reinforced by a proximal circumferential band 40, a distal circumferential band 42, and multiple longitudinal retention strips 44. The proximal circumferential band 40 and the distal circumferential band 42 preferably have a thickness between 4-18 millimeters. The longitudinal retention strips 44 preferably have a thickness between 2-18 millimeters and a length that is preferably coextensive with the length of the fabric reinforcement layer 34. These additions allow for additional retention capability, an additional layer to prevent the socket from chafing the liner, and improving grip while donning and doffing the straight sleeve 600, especially for those patients with impaired dexterity. The proximal circumferential band 40, distal circumferential band 42, and longitudinal retention strips 44 are preferably made out of silicone but can also be made out of any thermoformable material that allows for rolling, brushing, or spraying onto the surface of the fabric reinforcement layer 34 during production.
[0040] Alternatively, as shown in FIG. 9, the straight sleeve 600 may only incorporate a proximal circumferential band 40 and distal circumferential band 42 as part of the fabric reinforcement layer 34. This allows for improved sealing against the socket 200 and prevention of migration by increasing adhesion to prevent excessive movement on the socket wall or patient limb.
[0041] FIG. 10 shows another alternative embodiment of straight sleeve 600 wherein the fabric reinforcement layer 34 only incorporates the longitudinal retention strips 44 and does not include the proximal circumferential band 40 or distal circumferential band 42. This embodiment carries the benefit of increased suspension and donning capabilities.
[0042] As shown in FIGS. 11A-12B, the pre-flexed sleeve 300 may have the proximal circumferential band 40 and distal circumferential band 42, as seen in FIG. 11B, or it may have the longitudinal retention strips 44, as seen in FIG. 12B. The benefits of incorporating these additions into the pre-flexed suspension sleeve 300 are the same as described in FIGS. 7-10.
[0043] The present disclosure includes that contained in the appended claims, as well as that of the foregoing description. Although this invention has been described in its preferred form with a certain degree of particularity, it is understood that the present disclosure of the preferred form has been made only by way of example and that numerous changes in the details of construction and the combination and arrangement of parts may be resorted to without departing from the spirit and scope of the invention.
[0044] Now that the invention has been described,