PROSTHESIS SUSPENSION LINER SEALING CAP AND PROSTHESIS SUSPENSION SYSTEM

Abstract

A prosthesis suspension system comprises a socket for receiving a residual limb, a locking liner having a locking pin for attaching the liner to the socket and a sealing cap disposed between the locking line and the socket. The system further comprises a gap between a skirt of the sealing cap and an interior wall of the socket in which the skirt of the sealing cap is able to move between first and second positions.

Claims

1. A sealing cap for a porous prosthesis liner, the sealing cap comprising: a first portion comprising means for locating the sealing cap on a distal end of a said liner; a second portion which is resiliently deformable and movable between, a first position where the second portion is adapted to abut a corresponding portion of the said liner, and a second position where the second portion is adapted to be spaced from said corresponding portion of the said liner.

2. The sealing cap as claimed in claim 1, wherein the means for locating the sealing cap on a distal end of the said liner comprises means for preventing lateral movement of the sealing cap relative to the distal end of the said liner.

3. The sealing cap as claimed in claim 1, wherein the means for locating the sealing cap on a distal end of the said liner comprises a protrusion on one of the said liner and sealing cap and a cooperating recess on the other.

4. The sealing cap as claimed in claim 1, wherein the said liner comprises a boss and the means for locating the sealing cap on a distal end of the said liner comprises a cooperating recess in the sealing cap.

5. The sealing cap as claimed in claim 1, wherein the said liner is a locking liner comprising a bore, the sealing cap comprises an aperture adapted to be in communication with the said bore and the means for locating the sealing cap on a distal end of the said locking liner is a locking pin which is adapted to be fed through the aperture into the bore.

6. The sealing cap as claimed in claim 1, wherein the second portion is a skirt.

7. The sealing cap as claimed in claim 6, wherein the skirt has a frusto-conical shape.

8. The sealing cap as claimed in claim 7, wherein the first portion comprises a frusto-conical part between the means for locating the sealing cap on a distal end of a said liner and the skirt.

9. The sealing cap as claimed in claim 8, wherein the frusto-conical part of the first portion has a thickness less than a thickness of the skirt.

10. A prosthesis suspension system, comprising: a socket for receiving a residual limb and including mounting means for being mounted to a prosthetic limb; a liner having attachment means for attaching the liner to the socket; and the sealing cap as defined in claim 1, wherein the sealing cap is adapted to be disposed between the locking liner and socket, the system further comprising a gap between the skirt of the sealing cap and an interior wall of the socket in which the second portion of the sealing cap is able to move between its first and second positions.

11. The prosthesis suspension system as claimed in claim 10, wherein the attachment means for attaching the liner to the socket is one or more of a locking pin, a vacuum source, a seal between the liner and the socket and a sleeve for sealing a proximal edge of the socket.

12. The prosthesis suspension system as claimed in claim 11, wherein the socket has an expulsion port.

13. A prosthesis suspension system as claimed in claim 10, wherein the liner is perforated at its distal end where it is in contact with the skirt.

14. The prosthesis suspension system as claimed in claim 13, wherein the liner has an outer wicking layer and the distal end of the liner is perforated where it is in contact with the first portion of the sealing cap.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0027] The present invention will now be described by way of example only, and with reference to the accompanying drawings in which:

[0028] FIG. 1 is an exploded perspective view of a perforated liner and sealing cap forming part of the reduced pressure prosthesis suspension system in accordance with an embodiment of the invention;

[0029] FIG. 2 is a sectional view of the sealing cap shown in FIG. 1 in accordance with an embodiment of the invention;

[0030] FIG. 3 is a sectional view of the perforated liner and sealing cap shown in FIG. 1 when the sealing cap is disposed on the liner; and

[0031] FIGS. 4A and 4B are partial sectional views of the prosthesis suspension system in the region of the sealing cap when a skirt thereof is in a first and second position respectively.

DETAILED DESCRIPTION OF THE DRAWINGS

[0032] FIG. 1 is an exploded perspective view of a distal portion of a perforated locking liner 1 and sealing cap 3 forming part of a reduced pressure prosthesis suspension system in accordance with an embodiment of the invention. As is renowned in the art, in addition to the liner 1 and cap 3 shown in FIG. 1, the system further includes a socket and locking pin, not shown in FIG. 1.

[0033] The perforated liner 1 comprises a flexible silicone body covered circumferentially with a fabric layer 5. An end cap 7 is fixed to a distal end 9 of the liner 1. An outer face 11 of the end cap 7 has a frusto-conical portion 13 with a boss 15 protruding distally from its centre 17. The boss 15 has a threaded bore 19 at its centre. The distal end 9 of the liner 1 is perforated, the perforations 23 passing through the end cap 7 and the silicone body. The density of the perforations 23 is around 5-10 perforations per square cm. The density of perforations 23 may be reduced where the perforations 23 pass through the body of an internal umbrella, so as not to adversely compromise the structural rigidity of the umbrella. Conversely, the density of perforations 23 may be greater where the perforations pass through fenestrations (through holes) in the umbrella. Furthermore, the number of perforations 23 per square cm may vary depending on mechanical properties (such as the resilience) of the material from which the liner 1 is made. The perforations 23 in use allow passage of air and sweat from the interior of the liner 1 to its exterior over an extended area of the residual limb. Other than the perforations 23 passing through the end cap 7 of the liner 1, the liner 1 is impermeable in a region immediately proximal to the end cap 7 so that the only permeable zone of a distal region of the liner 1 is through the end cap 7. The impermeable region of the line 1 may extend to a proximal rim of the liner or may extend around 10 cm in that direction, with a perforated or otherwise permeable region extending proximally to the impermeable region.

[0034] The sealing cap 3 has a similar overall shape to the end cap 7 of the liner, having a generally frusto-conical portion 25 with a boss 27 extending from its centre 29. The boss 27 has a smooth walled (unthreaded) central through bore 31. The sealing cap 3 is made from silicone- and may be made from other resiliently deformable material such as urethane, rubber or other materials having a hardness within the Shore A scale. A preferred feature of the material of the sealing cap 3 is that it is resistant to the slightly acidic properties of perspiration.

[0035] The sealing cap 3 is shown in section in FIG. 2 and in FIG. 3 the sealing cap 3 is shown mounted on the distal end 9 of the liner 1. As can be seen in these Figures, the sealing cap 3 has a similar shape to the outer face 11 of the end cap 7. In particular the interior surface 33 of the sealing cap 3 is shaped to match the corresponding outer face 11 of the end cap 7. The interior surface 33 of the sealing cap 3 includes a boss recess 28 on the interior of the boss 27 which is shaped to fit over the boss 15 of the liner 1 such that the engagement of the boss 15 in the boss recess 28 locates the sealing cap 3 on the liner 1 by preventing relative lateral (left-right and in and out of the page as shown in the Figures) movement of these parts 1, 3.

[0036] The outer face 35 of the sealing cap 3 includes a plurality of concentric grooves or marks 37. The sole function of these grooves 37 is to assist cutting the sealing cap 3 to a required diameter. Since locking liners are supplied in different sizes the sealing cap 3 is manufactured having a diameter equal to or greater than the diameter of the largest supplied locking liner end cap and the grooves 37 are used as guides to aid a prosthetist or prosthetic technician in reducing the diameter of the sealing cap 3 to a suitable size. Alternatively sealing caps 3 without grooves or marks 37 and having different diameters may be manufactured, for example corresponding to the size of common liners.

[0037] The thickness of the sealing cap 3 differs between an inner circumferential band 39I of the frusto-conical portion 25 of the sealing cap 3 and an outer circumferential band 39O thereof. Whilst the interior surface 33F of the frusto-conical portion 25 of the sealing cap 3 has a generally frusto-conical shape, a step 41 is formed in the outer face 35 of the sealing cap 3 as the thickness of the sealing cap 3 transitions from a thickness t.sub.i of the inner circumferential band 39I of the frusto-conical portion 25 and a thickness t.sub.O of the outer circumferential band 39O of the frusto-conical portion 25, where t.sub.i>t.sub.O. The reduced thickness t.sub.O of the outer circumferential band 390, referred to herein as the ‘skirt’ of the sealing cap 3, makes this portion more flexible than the inner circumferential band 39I of the frusto-conical portion 25. It will be apparent to the skilled person that whilst the ‘full’ thickness t.sub.i inner circumferential band 39I of the frusto-conical portion 25 is the load bearing portion, bearing the weight of the amputee, the reduced thickness t.sub.O of the outer circumferential band 39O of the frusto-conical portion 25 allows this portion of the sealing cap 3 to move when the liner 1 and sealing cap 3 are within a socket, as explained below. For convenience we herein define the functional parts of the sealing cap 3 as the boss 27 and the inner circumferential band 39I of the frusto-conical portion 25 together forming a first portion of the sealing cap 3 which, in use, is held against the end cap 7 of the liner 1 and the outer circumferential band 39O of the frusto-conical portion 25 of the sealing cap 3 can be defined as a second portion.

[0038] As is known in the art, a first step of producing a socket for a residuum is forming a cast around the residuum when a liner is donned thereon. When casting a socket for the liner 1 described above it is necessary to apply a casting gasket over the reduced thickness skirt 39O so that when the final socket is applied to the liner 1 and sealing cap 3 a cavity will exist between the skirt 390 of the sealing cap 3 and socket, as described below with reference to FIGS. 4A and 4B.

[0039] FIGS. 4A and 4B are close-up sectional views of the prosthesis suspension system comprising the sealing cap 3 and liner 1 in a socket 43, with the skirt 39O of the sealing cap 3 in alternative positions. As described in the Background to the Invention above, the socket 43 is made of a hard impermeable material that is shaped to fit a residual limb 45.

[0040] In FIG. 4A, the liner 1 has been donned on the residual limb 45 of an amputee, the sealing cap 3 has been positioned over the end cap 7 of the liner 1, and the resulting combination has been inserted into the socket 43. The liner 1 includes a locking pin 47 which is screwed into the threaded bore 19 of the boss 15 of the liner, through the bore 31 of the boss 27 of the sealing cap 3 and through an aperture 49 in the socket 43, forming an airtight seal between the cap 3, boss 15 and distal end 9 of the liner 1. As can be seen in FIGS. 4A and 4B, the bore 31 is formed in a central stem 51 of an umbrella 53 which forms part of the liner 1. In addition to the stem 51 at its centre, the umbrella 53 has a disc portion 55 which extends outwards from the central stem 51 and which is embedded in the silicone of the liner 1. The disc portion 55 of the umbrella 53 includes a number of through holes 59 which are filled with silicone and which help anchor the umbrella 53 within the silicone.

[0041] FIGS. 4A and 4B also show the perforations 23 which pass from the interior surface 61 of the liner 1 to the outer face 11 of the end cap 7 and which allow passage of air and sweat from the interior surface 61 to its exterior 11. The two perforations 23 which are shown in solid lines fall along the sectional line of these Figures and the perforations 23 shown in broken lines are behind that sectional line. The socket 43 may include a one-way expulsion valve (not shown), as is known in the art. Additionally or alternatively a vacuum device may be used to maintain a reduced pressure within the socket 43.

[0042] When the sealing cap 3 is sandwiched between the distal end 9 of the liner 1 and the interior surface 63 of the socket, a gap 65 exists between the sealing cap 3 and the interior surface 63 of the socket 43. This gap 65 is as a result of the reduced thickness to of the skirt 39O of the sealing cap 3 beyond the step 41. The gap 65 extends from the step 41 to beyond a peripheral edge 67 of the sealing cap 3, such that the skirt 39O is able to move away from the outer face 11 of the end cap 3 and into that gap 65. Since the skirt 39O is resiliently deformable, its “at rest” position is as shown in FIG. 4A, where it is in contact with the outer face 11 of the end cap 7.

[0043] In use, when the residual limb 45 is surrounded by the liner 1 any sweat which is secreted from the skin of the amputee will cover the inner surface 61 of the liner and if left there can act as a lubricant, causing relative movement between the liner and residual limb, leading to chafing and discomfort to the amputee. Since the liner 1 is perforated in the region of the end cap 7, any sweat, air or other fluid in that region is expelled through the perforations 23 when the residual limb 45 loads the inner wall 61 of the liner 1. This loading occurs whilst the amputee is standing and during the stance phase of the gait cycle when the residual limb 45 “pistons” within the liner 1. As sweat is forced though the perforations 23 it pushes against the inner surface 33 of the sealing cap 3 in the region of the outer circumferential band 39O of the frusto-conical portion 25 and this part of the skirt 39O will be pushed away from the outer face 11 of the end cap and the skirt 390 moves into the gap 65. The sweat makes its way over the peripheral edge 67 of the sealing cap 3 and gathers in the gap 65, from where it may drain out of the socket via the locking mechanism, or can be drawn away via a one way valve (if present), in either case optimally using an elevated vacuum source, such as a vacuum pump.

[0044] On completion of the stance phase of the gait cycle as the lower limb lifts off the ground the residual limb 45 will have a tendency to be drawn away from the interior surface 63 of the socket 43 in the region of the end cap 7. During this phase of the gait cycle sweat will no longer be pushed through the perforations 23 and due to the resilience in the skirt 390 of the sealing cap 3 the interior wall 33 of the sealing cap 3 will return to its ‘at rest’ position and once again seal against the outer face 11 of the end cap 7. In addition or alternatively, the lifting of the residual limb 45 will cause a reduced pressure or partial vacuum in this region. This partial vacuum will be transmitted via the perforations 23 to the interior wall 33 of the sealing cap 3 and pull this against the outer face 11 of the end cap 7, thereby sealing the sealing cap 3 against the end cap 7. By sealing the end cap 7 in this manner the sealing cap 3 helps maintain a reduced pressure within the liner 1 which supports suspension of the liner 1 and the rest of the prosthesis from the residual limb 45. In this manner, the combined action of the skirt 390 of the sealing cap 3 and the end cap 7 of the liner 1 function as a valve to maintain a reduced pressure within the cavity of the liner 1.

[0045] As the amputee continues to walk this process is repeated, with sweat being forced through the perforations 23 of the liner 1 during the stance phase when the distal end 9 of the liner 1 is compressed and with sealing cap 3 being drawn against the outer face 11 of the liner 1 to seal the liner 1 during the swing phase.

[0046] Various modifications will be apparent to those in the art and it is desired to include all such modifications as fall within the scope of the accompanying claims.

[0047] For example, the body of the liner 1 in FIGS. 1-4B is made of impermeable silicone which is perforated at the distal end 21 of the liner 1. Whilst silicone is an impermeable material which in those Figures is perforated to make the liner 1 porous, instead of using silicone at the distal end 9 of the liner this part of the liner may be made from a porous material, such as a sintered material or fabric such as Gore-Tex(®), which does not need to be perforated to allow passage of air and moisture from the inside to the outside of the liner 1.

[0048] Since the displaceable skirt 39O of the sealing cap 3 is only in communication with peripheral perforations 23 in the distal end 21 of the liner 1 (i.e., those which are distal to the centre 17 of the end cap 7) the perforations 23 which are proximal to the centre 17 of the end cap may, in practice, be permanently sealed, since the inner surface 33 of the inner circumferential band 39I of the frusto-conical portion 25 of the sealing cap 3 permanently abuts that portion of the end cap. This may lead to a build-up of moisture on the interior surface 61 of the liner 1 towards its axial centre. To address this situation an inner portion of the outer face 11 of the end cap 7 may be covered by a porous membrane, such as a fabric layer. The fabric layer will act as a wicking/transmission layer and allow sweat to be pushed from the interior surface 61 of the liner 1, through the inner perforations 23 and along the fabric layer to the peripheral edge 67 of the sealing cap 3. In order to allow the sealing cap 3 to function as a valve by sealing against the outer face 11 of the end cap 7, an outer circumferential band of the outer face 11 of the end cap 7 should be free from a porous covering, so that when it is in contact with the corresponding part of the sealing cap 3 it provides a seal.

[0049] In the embodiments described above the sealing cap 3 is a separate piece from the locking liner. In other embodiments the sealing cap may be permanently fixed to the distal end of the locking liner. For example, the sealing cap may be glued or otherwise bonded to the locking liner when the two parts are first mated. Alternatively the sealing cap may be integrally formed on the end cap of the locking liner. If the sealing cap is fixed to the locking liner it would be joined in the region of the boss 15 of the liner so that the skirt 39O is free to move away from and back towards the end face 11 of the locking liner 1, so as to provide the valve functionality.

[0050] In the embodiment described above, the thickness of the sealing cap 3 transitions from a thickness t.sub.i of the inner circumferential band 39I of the frusto-conical portion 25 to a thickness t.sub.O of the outer circumferential band 39O of the frusto-conical portion 25, where t.sub.i>t.sub.O. In other embodiments the thickness of the frusto-conical portion 25 may be constant as it extends outwards from the boss 27 or it may decrease gently, without having a step 41. In such embodiments the ability of the outer circumferential band 39O to move as a valve may be provided by having a step in one or both of the end cap 7 of the liner 1 and in the interior wall 63 of the socket, thereby defining a gap in which the outer circumferential band 39O may reciprocate.

[0051] Whilst the embodiment described with reference to the Figures uses a locking liner and locking pin, the invention can also be embodied in a cushion (non-locking) liner. To achieve this the cushion liner and sealing cap will need to be adapted to locate the sealing cap on the distal end of the liner in such a manner where lateral movement of these parts is inhibited. Whilst the embodiment shown in the Figures uses a boss 15 on the liner and a cooperating recess 28 on the sealing cap 3, since a cushion liner does not typically include a boss, other mechanical interfaces can be used to locate the sealing cap on the distal end of the cushion liner. These mechanical interfaces may comprise a protrusion on one of the liner and the sealing cap and a cooperating recess on the other of the liner and the sealing cap. Alternatively other locating means can be used such as hook and loop fastener, other mechanical engagements or magnets.

[0052] In the embodiment described above, the different thicknesses t.sub.i, t.sub.O of the sealing cap 3 are provided by the inner circumferential band 39I and the outer circumferential band 39O of the frusto-conical portion 25. Since the function of the full thickness t.sub.i portion is to bear the load of the amputee and the function of the reduced thickness t.sub.O portion is to allow that portion of the sealing cap 3 to move away from and back towards the end cap 7 of the liner 1, the full thickness t.sub.i portion and the reduced thickness t.sub.O portion can be arranged other than concentrically. For example the outer circumferential band may be of full thickness and the inner circumferential band may be of a reduced thickness, so that the inner circumferential band moves away from and back towards the liner end cap 7 during the gait cycle. According to this arrangement the inner circumferential band would include perforations or other holes or slits to allow passage of sweat etc. from the interior surface 31 of the sealing cap 3 to the interior surface 61 of the socket 43. These holes or slits would not be aligned with the perforations 23 of the liner 1, so that the inner circumferential band will seal against the liner end cap 7 when abutted thereto. Alternatively the full thickness portions may be formed as radially extending spines with reduced thickness portions therebetween.

[0053] The sealing cap 3 described above is disposed on the distal end 9 of the liner 1. In other embodiments a sealing cap or flap may be disposed at a different position of the liner 1 corresponding to a perforated portion of the liner 1. For example, if a side wall of the liner 1 is perforated instead of or in addition to the distal end 9 of the liner, the sealing cap would have a portion which is movable between a first position (where it is adapted to abut the perforated portion of the liner) and a second position (where it adapted to be spaced from that portion of the liner) in accordance with the invention. As described above the sealing cap or flap may be a separate piece from the liner or permanently attached thereto.

[0054] In our earlier patent application published as US-A-2012/191218, the contents of which are incorporated herein by reference, we describe a vacuum-assisted suspension device for a lower limb prosthesis which secures the prosthesis to a residual body portion. FIG. 8D of that publication describes the use of voids 104V in a surface of a pad 104. The voids 104V are open to the surface 104O of the pad 104 and have a blind end in the body of the pad 104. The voids 104V assist in evacuating air from between the socket and the stump, as described in that publication, when the pad 104 is repeatedly compressed. Similarly voids may be incorporated in one or both of the end cap 7 of the perforated liner 1 and the sealing cap 3, with the voids being open to the outer face 11 of the end cap 7 and the interior surface 33 of the sealing cap respectively. Similarly, other voids as described in that publication can be used to enhance the vacuum between the end cap 7 and the sealing cap 3.