Prosthetic gasket with external resilient seal

Abstract

A suspension liner sleeve configured to create a vacuum between a stump and a prosthetic socket, comprising: an elongate tubular body portion comprising a cushioning material having a tubular thickness, a vertical shaft defining an open proximal end and a closed distal end; a fabric outer layer bonded to the tubular body portion; and at least one sealing element bonded to the fabric outer layer, the sealing element being not integral with the thermoplastic elastomer material of the tubular body portion, where the sealing element further comprises a sealing element base and a single engaging member extending radially outward.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to pending application No. 17 / 876,764, filed on July 29, 2022, which is a part-continuation application of application No. 17 / 546,510, entitled “Prosthetic Cushion with External Fabric Seal”, filed on December 9, 2021, which is a part-continuation application of application No. 16 / 258,621, entitled “Prosthetic Cushion with External Fabric Seal”, filed on January 27, 2019, which is a part-continuation application of application No. 16 / 120,791, entitled “Prosthetic Cushion with External Fabric Seal”, filed on September 4, 2018, which claims priority to U.S. Provisional Application No. 62 / 554,370, filed on September 5, 2017, the contents of which are incorporated herein by reference. Technical Field

[0003] The present invention relates to a cushion for use in a prosthetic assembly. More particularly, the present invention relates to a vacuum sealing cushion having a thermoplastic elastomer layer including at least one sealing element such that an airtight seal is formed when a vacuum is applied in the area between a prosthetic socket and the sealing cushion. Background Art

[0004] Currently, it is recognized that suspended liners provide a sealing protection between the residual limb and the prosthetic socket, as shown in U.S. Patent No. 8,097,043 to Egilsson, the disclosure of which is incorporated herein by reference. Such a liner sleeve is generally made of an air-impermeable elastomeric material (such as silicone) and may include a reinforcement layer between the inner and outer surfaces of the liner sleeve body portion or outside thereof to provide resistance to axial elongation of the elastomer forming the liner sleeve body. Such reinforcement generally does not limit radial expansion or stretching of the liner sleeve body.

[0005] When configuring a suspension pad to be securely retained within a rigid prosthetic socket, various arrangements have been considered, since the user's movements often cause the prosthesis to twist away from the user's residual limb. Among various approaches, such as a movement-pumping mechanism to remove any residual air in the space between the pad and the prosthesis, the most effective approach is to prepare a seal around the pad. Such a seal suspension pad has an elastomeric material attached to a knitted layer that provides friction-inducing properties to the pad itself. When a user inserts the residual limb with the attached suspension pad, the user actually forces their limb into the prosthetic socket, and then snaps an annular seal having a larger circumference than the suspension pad into the prosthesis.

[0006] In other applications, it may be desirable to more securely secure the liner sleeve in the socket by creating a low pressure (vacuum) pressure at the distal end of the hard socket and within the distal end of a suspended liner sleeve inserted into the socket. The low pressure can be maintained at the distal end of the hard socket, and the interior of the socket at its distal end will be isolated from the atmosphere during normal retention of the sleeve liner in the socket. Opening the distal end of the socket to the atmosphere releases the vacuum or low pressure within the socket, thereby enabling simple removal of the residual limb with the liner sleeve from the socket. A pump or other device can be used to evacuate the distal end of the socket between the distal end of the liner sleeve and the distal end of the socket. A valve or other suitable device is typically used to open and close the distal end of the socket to the surrounding atmosphere.

[0007] Other arrangements are known in the art for providing an adequate seal between the exterior of the cushion sleeve and the interior of the hard socket, which seal includes an outer air-impermeable sleeve covering the interface area between the proximal end of the hard socket and the adjacent cushion sleeve body.

[0008] It is therefore an object of the present invention to provide an improvement which overcomes the above-mentioned deficiencies of prior art devices and which makes a significant contribution to the advancement of gasket technology.

[0009] Another object of the present invention is to create a convenient, improved seal arrangement between the elastomeric liner sleeve and the interior of the prosthetic socket.

[0010] The foregoing summarizes some of the relevant objects of the present invention. These objects should be construed as merely illustrating some of the more prominent features and applications of the contemplated invention. Many other beneficial results may be obtained by applying the disclosed invention in different ways or modifying the invention within the scope of the present disclosure. Therefore, in addition to the scope of the invention defined by the claims in conjunction with the accompanying drawings, other objects may be achieved and the present invention may be more fully understood by reference to the summary of the present invention and the detailed description of the preferred embodiments. Summary of the invention

[0011] The present invention generally relates to a ridged layered cushion for use in a prosthetic assembly. In particular, the present invention relates to a cushion having an elastomeric layer, a fabric outer layer, and at least one sealing element comprising a single radially extending straight or arcuate silicone or thermoplastic gel engaging member, wherein the sealing element is glued to the fabric outer layer. The fabric outer layer is bonded to the outer surface of the elastomeric layer. As an alternative, the sealing element may be glued to the cushion including a distal lock.

[0012] The foregoing has been a fairly broad overview of the more relevant and important features of the present invention so that the detailed description of the present invention below will be better understood, and thus the contribution of the present invention to the field of technology can be fully appreciated. Additional features of the present invention will be described below, and these features form the subject matter of the claims of the present invention. It will be appreciated by those skilled in the art that the disclosed concepts and specific embodiments can be easily used as a basis for modifying or designing other structures for the same purpose of implementing the present invention. It will also be appreciated by those skilled in the art that such equivalent constructions do not depart from the spirit and scope of the present invention as set forth in the appended claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] For a more complete understanding of the present disclosure and its advantages, reference is now made to the following description taken in conjunction with the accompanying drawings, in which:

[0014] Figure 1 is a cross-sectional view of a thermoplastic layer;

[0015] Figure 2 is a cross-sectional view of a preferred embodiment of a suspension sleeve liner;

[0016] Figure 3-11 is with Figure 2 a corresponding cross-sectional view of a suspension sleeve liner showing alternative embodiments of raised and recessed portions;

[0017] Figure 12-13 is a cross-sectional view of a suspension sleeve liner showing an alternative embodiment of a raised portion;

[0018] Figure 14-15 is a cross-sectional view of a suspension sleeve pad showing an alternative embodiment of the raised portion, particularly a pad having an elastomeric material impregnated within a fabric outer layer;

[0019] Fig.16 is a perspective view of an alternative embodiment of a thermoplastic elastomer liner in which a sealing element is glued to the outer layer of fabric;

[0020] Fig.17 yes Fig.16 A cross-sectional view along line AA;

[0021] Figure 17-1 is an enlarged view of the cross-section, showing Fig.16 Details of the sealing element area B;

[0022] Fig.18 is a perspective view of a thermoplastic elastomer liner with a plurality of sealing elements glued to a fabric outer layer;

[0023] Figure 19-21 is a perspective view of a thermoplastic elastomer liner showing sealing elements at various locations on the liner;

[0024] Fig. 22 and Fig.23 is a perspective view of a thermoplastic elastomer liner before the sealing element is glued to the fabric outer layer;

[0025] Fig.24 is a perspective view of another alternative embodiment wherein the thermoplastic elastomer liner includes a lock and a sealing element at a distal end; and

[0026] Fig.25 yes Fig.24 Cross-sectional view along line CC.

[0027] Like reference numerals refer to like parts throughout the several views of the drawings. DETAILED DESCRIPTION

[0028] The following description is the best mode currently contemplated for carrying out the present invention. This description should not be considered in a limiting sense, but is only used for the purpose of describing one or more preferred embodiments of the present invention. The scope of the present invention should be determined with reference to the claims.

[0029] Figure 1 Thermoplastic elastomer layer 400 of seal liner 100 is shown, wherein thermoplastic elastomer layer 400 (also referred to as TPE) having inner elastomeric surface 410 and outer elastomeric surface 420 is formed in a mold having a wall thickness of 2 mm to 9 mm. The liner 100 preferably has an open proximal end 120 having a greater circumference and volume than the closed distal end 400.

[0030] Figure 2 1 shows a preferred embodiment of the seal liner 100, wherein the thermoplastic elastomer layer 400 further includes at least one sealing area 430, which preferably extends 3 mm to 20 mm outward from the inner surface 410 of the thermoplastic elastomer layer 400 and includes at least one raised portion 440. If more than one raised portion 440 is included in the sealing area 430, the plurality of raised portions 440 will be accompanied by at least one recessed portion 450. Thus, if there are two raised portions 440, then three recessed portions 450 will be as shown. Figure 1 Alternatively, the sealing area 430 may start from the raised portion 440 instead of the recessed portion 450. In this case, the distribution is as follows: raised portion 440, recessed portion 450, raised portion 440. Therefore, the recessed portion 450 does not always have to surround the distal and proximal ends of the sealing area 430.

[0031] The fabric outer layer 300 is synonymous with a "reinforcement layer" and is bonded to the outer elastomeric surface 420 of the thermoplastic elastomer layer 400 and conforms to at least one sealing area 430. The fabric outer layer 300 advantageously forms a suitable substrate for bonding the sealant layer 200. The sealant layer 200 conforms to the shape of the fabric outer layer 300 and the thermoplastic elastomer layer 400. The sealant layer 200 is applied to the fabric in a generated state, and its viscosity enables it to "saturate" the fabric in this area, so that once cured, it forms an airtight seal, thereby isolating the fabric above the sealant layer (not shown) from the fabric outer layer 300 below the sealant layer 200. Thus, the outer sealant layer 200 is applied to the fabric outer layer 300, providing an airtight interface between the thermoplastic elastomer layer 400 and the surrounding external area of ​​the liner 100. The outer sealant layer 200 is preferably applied so that it impregnates the reinforcement layer 300 to form a composite material.

[0032] The outer seal layer 200 may be composed of natural rubber, silicone, polyurethane, latex, polysulfide, vinyl, polyisoprene or styrene block copolymer gel, although the preferred material is rubber because of its high abrasion resistance and high tensile force. The force to stretch the layer is determined by the elastic modulus of the sealing material multiplied by the cross-sectional area of ​​the sealing material.

[0033] The thermoplastic elastomer layer 400 is preferably of a type compatible with prolonged dynamic wearer contact. Such materials are known in the art and may include the following polymers as well as gels, general non-limiting examples of which may include SEBS-, SEPS-, SEEPS-, SEEBS- and other types of styrene block copolymer gels. Other non-limiting examples of styrene block copolymer gels may be used in the cushions of the present invention, including so-called "controlled distribution polymers", such as, for example, those disclosed in U.S. Patent No. 7,226,484; U.S. Patent Application Publication No. 20070238835; and U.S. Patent Application Publication No. 20050008669, the disclosures of which are incorporated herein by reference. Other potentially useful polymers may include so-called "crystalline" polymers, such as, for example, those disclosed in U.S. Patent Nos. 5,952,396; 6,420,475 and 6,148,830, the disclosures of which are incorporated herein by reference. The above is non-limiting, and generally, the list of acceptable polymers and gels includes those known in the art to be useful for making prosthetic cushions. The term "gel" is defined as a polymer mixed with a plasticizer. An example of a pad currently using such a gel is the "EZ-Gel"™ pad, available from AlpsSouth, LLC.

[0034] The term "sealing zone" 430 may include only one raised portion 440, or may include multiple raised portions. If it includes multiple raised portions 440, the sealing zone 430 will have each raised portion 440 continuously adjacent to any other raised portion 440. However, if there are multiple raised portions 440 collectively near the distal end of the tubular body portion, and multiple raised portions 440 collectively near the proximal end of the tubular body portion, there will be two sealing zones 430 in their group that have only continuous lengths. That is, the sealing zone 430 in the distal end will have one continuous length of material, while the sealing zone 430 in the proximal end will have its own continuous length of material. The continuous length of material refers to the elastomeric material used to form the durable and flexible sealing zone 430.

[0035] Figure 2-11 It is shown that the raised portion 440 in the elastomeric material can have a variety of different geometric shapes relative to the vertical axis of the present invention. For example, the raised portion 440 can have a square / rectangular ( Figure 2-4 , 6), parabola ( Fig.11 ), triangle, ellipse, spear, parallelogram ( Figure 5 ), dome ( Fig.11 ), wavy ( Figure 7 and 9 ), or protrusions similar to the "grasping" mechanisms or shapes used by those skilled in the art to "grasp" an object to another object. For example, finger-like protrusions ( Figure 8 and 10 ) is similar to a hook, which is similar to the "hook" portion of the "hook and loop" configured for Velcro®. As shown in the relevant drawings, each raised portion 440 is preferably not in line with the fabric outer layer 300.

[0036] Fig.12 and Fig.13 The seal gasket 100 is shown without the recessed portions 450 in the elastomeric layer 400. The raised portions 440 protrude from the elastomeric layer 400 without the recessed portions 450 located between, in, or near the raised portions 440. This embodiment of the seal gasket 100 is useful because it is easy to manufacture and has a thinner profile. Only the reinforcement layer 200 and the fabric outer layer 300 have the recessed portions 450, which correspond to the recessed portions 450 between each of the raised portions 440.

[0037] Fig.14 Another embodiment of the seal gasket 100 is shown which includes an elastomeric material impregnated into the fabric outer layer 300 along the entire length of the sealing area 430. The elastomeric material at least partially penetrates into the fabric outer layer 300, and is preferably completely impregnated into the fabric outer layer 300.

[0038] Furthermore, impregnating the elastomeric material within the fabric outer layer 300 may provide the resulting composite material with more durable properties (compared to attaching the elastomeric material as its own layer outside the fabric outer layer 300). Figure 2-13 That is, the fabric outer layer 300 in combination with the impregnated elastomeric material has properties similar to placing reinforcing bars ("rebar") within a concrete structure.

[0039] Fig.15 The use of a top surface 470 with raised portions 440 is shown. The elastomeric material is completely impregnated into the fabric outer layer 300 only on the top surface 470 of the raised portions 440, which is consistent with Fig.14 on the contrary, Fig.14 The elastomeric material is shown impregnated into the fabric outer layer 300 along the entire length of the sealing area 430 .

[0040] In addition, the top surface 470 is the highest or farthest point from the recessed portion 450. Figure 7 In the case of the illustrated embodiment, for example, the top surface 470 would be relatively located at the "tip" of the triangular convex portion 440 and extend downwardly toward the concave portion 450. Figure 8 In the embodiment of the present invention, the top surface 470 will be the end of the finger-like protrusion. The top surface 470 can also be regarded as the surface area of ​​the protrusion 440 that contacts the socket wall.

[0041] Prepare Fig.14 and Fig.15 The embodiment shown includes four steps. First, a tube with an inflatable bladder is inserted into the seal liner 100. The inflatable bladder is positioned near the sealing area 430. The area of ​​the raised portion 440 is then wrapped with vinyl tape to prevent any unwanted silicone from adhering to any other area outside the top surface 470 of the raised portion 440. The border created from the applied vinyl tape will define the edge of the sealing area. The bladder is then expanded using compressed air, which will stretch the fabric outer layer 300 to allow the silicone to penetrate the fabric outer layer 300. The tube is then placed on a rotating arm that will rotate the seal liner 100 to allow the top surface 470 of the raised portion 440 to be evenly coated while preventing the silicone from dripping by using the principle of centrifugal force.

[0042] Second, a calibrated scale and clean mixing container are used to prepare and mix the desired silicone for application to the top surface 470 of the raised portion 440. Although silicone is used as the sealing material in this method, any equivalent material may be used.

[0043] Third, the seal liner 100 is rotated while the prepared silicone is applied to the top surface 470 of the raised portion 440 using a brush or other applicator. The silicone applied is uniform and is introduced only into the areas within the sealing area 430 where no vinyl tape is applied. No air bubbles should be present within the applied silicone. The air bladder is then deflated and the vinyl tape removed.

[0044] Fourth, the seal gasket 100 is slowly rotated on the rotating arm while an infrared heat lamp is applied about 1 inch from the silicone surface. The seal gasket 100 is cured for about 10 minutes to 20 minutes, or until the silicone is no longer tacky to the touch. If the silicone coating is still liquid or soft, the seal gasket 100 is kept rotating to cure longer. Once the silicone is cured enough to remain in place without rotation, the seal gasket 100 is moved to a clean location to complete the cure overnight at room temperature.

[0045] Additionally, the impregnation of the fabric outer layer 300 with silicone may be accomplished in a variety of ways, including applying a preformed semi-cured silicone strip to the top surface 470 of the raised portion 440. The application process may include painting, spraying, coating, spreading, injecting, molding, or dipping the seal gasket 100 into the silicone material without expanding the seal gasket 100.

[0046] A number of stress and wear tests were successfully conducted to demonstrate that the seal gasket 100 would maintain a vacuum in use because of its durable sealing area 430. The seal gasket 100 was first vacuum tested to determine a baseline of the vacuum level achieved within the seal gasket 100 and the socket (vacuum achieved to 23 inches of mercury, vacuum maintained to 20 inches of mercury, and test duration was 24 hours). After the baseline was established, the elastomeric material impregnated within the fabric outer layer 300 was gradually removed by abrasive forces to monitor the vacuum level created. The first sanding step removed a small layer of the elastomeric material impregnated within the fabric outer layer 300 at the top surface 470 of the raised portion 440 (vacuum achieved to 22.5 inches of mercury, vacuum maintained to 20 inches of mercury, and test duration was 24 hours). There was no noticeable loss of vacuum. The second sanding step removed a thicker layer of elastomeric material impregnated with the fabric outer layer 300, and again no significant vacuum loss was achieved (vacuum reached 18.5 inches of mercury, vacuum maintained 17.5 inches of mercury, and the test duration was 24 hours). The sanding step continued until gradually, each raised portion 440 had a significant loss of impregnated elastomeric material within the fabric outer layer 300 (vacuum reached 23 inches of mercury, vacuum maintained 20 inches of mercury, and the test duration was 24 hours). No significant vacuum loss was achieved. During the many tests of the sanding step, the seal gasket 100 never lost more than 4.5 inches of mercury, and the average loss never exceeded 2 inches of mercury.

[0047] When worn by an amputee and inserted into the socket for use with a vacuum system, the volume of air within the socket and beneath the seal layer is evacuated, thereby securing the residual limb within the socket. Thus, the present invention preferably reduces any likelihood of a tourniquet effect from the vacuum process and provides high wear resistance.

[0048] Figure 16-25 Alternative implementations are provided. Figure 16-17 As shown, instead of making the elastomeric seal integral with the thermoplastic elastomer layer 400 and impregnating the fabric outer layer 300,

[0049] The seal liner 100 will have a sealing element 500, which can be made of silicone or an elastomeric compound (such as polyurethane), which is not integral with the fabric outer layer 300 or the cushioning layer 900, which can be made of silicone or a thermoplastic elastomer (such as SEEPS). The sealing element 500 is preferably made of silicone or some other thermoplastic elastomer and is bonded to the fabric outer layer 300 of the seal liner 100, thereby forming an adhesive layer 510. Preferably, the adhesive of the adhesive layer 510 is glue. The sealing element 500 also includes a joining member 520 extending radially outward from the sealing element base 530. The joining member 520 can be substantially straight (such as Figure 17-1 ), or it can be arched (as shown in Fig.23 ). An advantage of this embodiment is that it allows the thermoplastic elastomer layer 400 to be made of a different material than the sealing element 500. For example, the sealing element 500 can be made of silicone while the cushioning layer 900 can be made of SEEPS gel, or vice versa.

[0050] like Figure 8 As shown, the seal cushion 100 may have one seal element 500, but may have up to two additional seal elements 600, 700, which may be bonded anywhere on the seal cushion 100, but are preferably located near the closed distal end 140 to provide maximum support to the user. Figure 19-21 As shown, the sealing element 500 can be placed at different positions on the sealing member liner 100; at the closed distal end 140 (such as Fig.19 ), about one third of the distance from the closed distal end 140 (as shown Fig. 20 ), and the midpoint 650 of the seal liner 100 (as shown Fig.21 As shown in Fig. 22 and Fig.23 As shown, the sealing element 500 is initially separated from the seal liner 100 and glue is applied only to the inner surface 540 of the sealing element 500 .

[0051] In yet another embodiment, Fig.24and Fig.25 As shown, a sealing element 500 may be used on a pad incorporating a distal lock 800 at the closed distal end 140. Such a distal locking system has been previously disclosed in co-owned U.S. Patent 11,224,527 to Laghi. The benefit of this arrangement is that the prosthesis provides further support to the user when in use. As in the previous embodiment, the sealing element 500 is glued to the fabric outer layer 300.

[0052] The present disclosure includes what is contained in the appended claims as well as what is contained in the foregoing description. Although the present invention has been described in preferred forms with a certain degree of particularity, it should be understood that the present disclosure of the preferred forms is by way of example only and that many changes may be made to the details of construction and the combination and arrangement of parts without departing from the spirit and scope of the present invention.

Claims

1. A floating cushion sleeve configured to create a vacuum between a residual limb and a prosthetic socket, comprising: an elongated tubular body portion comprising a cushioning material having a tubular thickness and defining a vertical axis with an open proximal end and a closed distal end; a fabric outer layer bonded to the tubular body portion; as well as At least one sealing element is bonded to the fabric outer layer, the sealing element being non-integral to the thermoplastic elastomer material of the tubular body portion, wherein the sealing element further comprises a sealing element base and a single engagement member extending radially outwardly.

2. The floating cushion sleeve of claim 1, wherein the engagement member is substantially straight.

3. The floating cushion sleeve of claim 1, wherein the engagement member is arcuate.

4. The floating liner sleeve of claim 1, wherein the tubular body portion further comprises a distal lock located at the closed distal end.

5. The suspension liner sleeve of claim 1, wherein the suspension liner sleeve comprises at least three sealing elements.

6. The suspension liner sleeve of claim 1, wherein the sealing element is bonded at a midpoint along the suspension liner sleeve.

7. The floating liner sleeve of claim 1, wherein the sealing element is bonded about one-third of the distance from the closed distal end toward the open proximal end.

8. The floating liner sleeve of claim 1, wherein the sealing element is bonded at the closed distal end.

9. The suspension cushion sleeve of claim 5, wherein a first sealing element is bonded at a midpoint along the suspension cushion sleeve, a second sealing element is bonded about one-third of the distance from the closed distal end toward the open proximal end, and a third sealing element is bonded at the closed distal end.

10. The suspension pad of claim 1, wherein the cushioning material comprises silicone.

11. The suspension pad of claim 1 , wherein the cushioning material comprises an elastomeric compound.

12. The suspension pad of claim 11, wherein the elastomeric compound is polyurethane.

13. The suspension pad of claim 11, wherein the elastomeric compound is a thermoplastic elastomer gel.

14. The suspension liner sleeve of claim 10, wherein the sealing element comprises an elastomeric compound.

15. The suspension pad of claim 11, wherein the sealing element comprises silicone.

16. A floating cushion sleeve configured to create a vacuum between a residual limb and a prosthetic socket, comprising: an elongated tubular body portion including a cushioning material having a tubular thickness, a vertical axis defining an open proximal end and a closed distal end, and a distal lock integrally positioned within the closed distal end; a fabric outer layer bonded to the tubular body portion; as well as At least one sealing element is bonded to the fabric outer layer, the sealing element being non-integral to the cushioning material of the tubular body portion, wherein the sealing element further comprises a sealing element base and a single straight engagement member extending radially outwardly.

17. The floating liner sleeve of claim 16, wherein the tubular body portion further comprises a distal lock located at the closed distal end.

18. The suspension liner sleeve of claim 16, wherein the suspension liner sleeve comprises at least three sealing elements.

19. The suspension liner sleeve of claim 16, wherein the sealing element is bonded at a midpoint along the suspension liner sleeve.

20. The floating liner sleeve of claim 16, wherein the sealing element is bonded approximately one-third of the distance from the closed distal end toward the open proximal end.

21. The floating liner sleeve of claim 16, wherein the sealing element is bonded at the closed distal end.

22. The suspension pad of claim 20, wherein a first sealing element is bonded at a midpoint along the suspension pad sleeve, a second sealing element is bonded about one-third of the distance from the closed distal end toward the open proximal end, and a third sealing element is bonded at the closed distal end.

23. The suspension pad of claim 16, wherein the cushioning material is silicone.

24. The suspension pad of claim 16, wherein the cushioning material is an elastomeric compound.

25. The suspension pad of claim 16, wherein the elastomeric compound is polyurethane.

26. The suspension pad of claim 16, wherein the elastomeric compound is a thermoplastic elastomer gel.

27. The suspension liner sleeve of claim 23, wherein the sealing element comprises an elastomeric compound.

28. The suspension liner sleeve of claim 24, wherein the sealing element comprises silicone.

29. A floating cushion sleeve configured to create a vacuum between a residual limb and a prosthetic socket, comprising: an elongated tubular body portion comprising a cushioning material having a tubular thickness, a vertical axis defining an open proximal end and a closed distal end, and a distal lock located at the closed distal end; a fabric outer layer bonded to the tubular body portion; as well as At least one silicone sealing element bonded to the fabric outer layer, the silicone sealing element being non-integral to the cushioning material of the tubular body portion, wherein the sealing element further comprises a sealing element base and a single arcuate engagement member extending radially outwardly.

30. The suspension liner sleeve of claim 29, wherein the suspension liner sleeve comprises at least three sealing elements.

31. The suspension liner sleeve of claim 29, wherein the sealing element is bonded at a midpoint along the suspension liner sleeve.

32. The floating liner sleeve of claim 29, wherein the sealing element is bonded approximately one-third of the distance from the closed distal end toward the open proximal end.

33. The floating liner sleeve of claim 29, wherein the sealing element is bonded at the closed distal end.

34. The suspension pad of claim 30, wherein a first sealing element is bonded at a midpoint along the suspension pad sleeve, a second sealing element is bonded about one-third of the distance from the closed distal end toward the open proximal end, and a third sealing element is bonded at the closed distal end.

35. The suspension pad of claim 29, wherein the cushioning material is silicone.

36. The suspension pad of claim 29, wherein the cushioning material is an elastomeric compound.

37. The suspension pad of claim 29, wherein the elastomeric compound is polyurethane.

38. The suspension pad of claim 29, wherein the elastomeric compound is a thermoplastic elastomer gel.

39. A suspended cushion sleeve configured to create a vacuum between a residual limb and a prosthetic cushion, comprising: an elongated tubular portion comprising an elastomeric compound having a tubular thickness, defining a vertical axis with an open proximal end and a closed distal end; a fabric outer layer bonded to the tubular body portion; as well as At least one silicone sealing element bonded to the fabric outer layer, the silicone sealing element being non-integral to the cushioning material of the tubular body portion, wherein the sealing element further comprises a sealing element base and a single arcuate engagement member extending radially outwardly.

40. A floating cushion sleeve configured to create a vacuum between a residual limb and a prosthetic socket, comprising: an elongated tubular portion comprising silicone having a tubular thickness defining a vertical axis with an open proximal end and a closed distal end; a fabric outer layer bonded to the tubular body portion; as well as At least one silicone sealing element bonded to the fabric outer layer, the silicone sealing element being non-integral to the cushioning material of the tubular body portion, wherein the sealing element further comprises a sealing element base and a single arcuate engagement member extending radially outwardly.

41. A floating cushion sleeve configured to create a vacuum between a residual limb and a prosthetic socket, comprising: an elongated tubular portion comprising an elastomeric compound having a tubular thickness, defining a vertical axis with an open proximal end and a closed distal end; a fabric outer layer bonded to the tubular body portion; as well as At least one sealing element comprises an elastomeric compound bonded to the fabric outer layer, the sealing element being non-integral to the cushioning material of the tubular body portion, wherein the sealing element further comprises a sealing element base and a single arcuate engagement member extending radially outwardly.

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