U.S. patent application number 17/022763 was filed with the patent office on 2020-12-31 for methods of fabricating skeletal stabilization liner system.
The applicant listed for this patent is Randall D. Alley. Invention is credited to Randall D. Alley.
Application Number | 20200405509 17/022763 |
Document ID | / |
Family ID | 1000005090529 |
Filed Date | 2020-12-31 |
United States Patent
Application |
20200405509 |
Kind Code |
A1 |
Alley; Randall D. |
December 31, 2020 |
Methods of Fabricating Skeletal Stabilization Liner System
Abstract
Methods of fabricating a liner for reducing motion between a
socket and a skeletal structure in a body part are described.
Methods include selecting a plurality of compression areas, lying
the compression areas along the longitudinal axis of the liner, and
spacing the compression areas circumferentially around the liner.
The durometer, radial thickness, width, and longitudinal dimension
of the compression areas are selected to compress soft tissue of
the body part against the skeletal structure to reduce motion of
the skeletal structure towards a wall of the socket. Methods also
include selecting a plurality of attachment areas on the liner and
affixing a plurality of attachment area materials to the plurality
of attachment areas. The durometer, radial thickness, width, and
longitudinal dimension of the attachment area materials are
selected to compress soft tissue of the body part and reduce motion
of the skeletal structure towards a wall of the socket.
Inventors: |
Alley; Randall D.; (Thousand
Oaks, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Alley; Randall D. |
Thousand Oaks |
CA |
US |
|
|
Family ID: |
1000005090529 |
Appl. No.: |
17/022763 |
Filed: |
September 16, 2020 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15019683 |
Feb 9, 2016 |
10806606 |
|
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17022763 |
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62115142 |
Feb 11, 2015 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 2/80 20130101; A61F
2/7812 20130101; A61F 2002/785 20130101; A61F 2240/001 20130101;
A61F 2/7843 20130101; A61F 2/5044 20130101 |
International
Class: |
A61F 2/80 20060101
A61F002/80; A61F 2/50 20060101 A61F002/50; A61F 2/78 20060101
A61F002/78 |
Claims
1. A method of fabricating a liner for reducing motion between an
interface and a skeletal structure in a body part, the method
comprising: selecting a plurality of compression areas each having
a durometer, a radial thickness, a width, and a longitudinal
dimension; lying the longitudinal dimension of each compression
area along a longitudinal dimension of the liner, wherein the
longitudinal dimension of the liner extends from a distal end to a
proximal end of the liner; spacing each compression area
circumferentially around the liner; and selecting the durometer,
radial thickness, width, and longitudinal dimension of the
plurality of compression areas to compress soft tissue of the body
part against the skeletal structure when the interface and liner
are worn on the body part such that motion of the skeletal
structure towards a wall of the interface is reduced.
2. The method of claim 1, wherein each compression area comprises a
gel.
3. The method of claim 2, wherein the gel is selected from the
group consisting of a shear-thinning gel, a shear-thickening gel, a
magneto rheological gel, an electrorheological gel, and a
thermoresponsive gel.
4. The method of claim 1, wherein each compression area extends at
least approximately 10% the longitudinal dimension of the
liner.
5. The method of claim 1, wherein the plurality of compression
areas have an increased thickness relative to the spaces between
the compression areas.
6. The method of claim 1, wherein a maximum radial thickness of
each compression area is at least 0.4 mm greater than a minimum
radial thickness of the areas between the compression areas.
7. The method of claim 1, wherein the proximal end and distal end
of the liner are both open ends.
8. The method of claim 1, wherein at least one area between the
plurality of compression areas is an open or low-compression
area.
9. The method of claim 1, further comprising the step of
integrating or attaching one or more sensors with one or more
compression areas.
10. The method of claim 9, further comprising the step of sending
data from the one or more sensors to a device.
11. The method of claim 10, wherein the data includes a localized
pressure.
12. The method of claim 1, further comprising the step of adjusting
a volume or durometer of at least one compression area.
13. A method of fabricating a liner for reducing motion between an
interface and a skeletal structure in a body part, the method
comprising: selecting a plurality of attachment areas each having a
durometer, a radial thickness, a width, and a longitudinal
dimension; lying the longitudinal dimension of each attachment area
along a longitudinal dimension of the liner, wherein the
longitudinal dimension of the liner extends from a distal end to a
proximal end of the liner; spacing each attachment area
circumferentially around the liner; selecting an attachment area
material for each of the plurality of attachment areas, wherein
each attachment area material has a durometer, a radial thickness,
a width, and a longitudinal dimension; affixing the attachment area
materials to the plurality of attachment areas, respectively, such
that the longitudinal dimension of each attachment area material
aligns with the longitudinal dimension of the liner; selecting the
durometer, radial thickness, width, and longitudinal dimension of
each attachment area material to compress soft tissue of the body
part against the skeletal structure when the interface and liner
are worn on the body part such that motion of the skeletal
structure towards a wall of the interface is reduced.
14. The method of claim 13, wherein at least one of the attachment
areas is in a discontinuous configuration.
15. The method of claim 13, wherein at least one of the attachment
areas comprises a pocket.
16. The method of claim 15, wherein the step of affixing the
attachment area materials to the plurality of attachment areas
comprises enclosing the attachment area material inside the
pocket.
17. The method of claim 15, wherein the step of affixing the
attachment area materials to the plurality of attachment areas
comprises inserting a shim into the pocket.
18. The method of claim 13, wherein the step of affixing the
attachment area materials to the plurality of attachment areas
comprises embedding a material in the attachment areas to increase
the thickness of the attachment areas.
19. The method of claim 13, wherein the plurality of attachment
areas have an increased thickness relative to the spaces between
the attachment areas.
20. The method of claim 13, wherein the step of selecting the
radial thickness, width, and longitudinal dimension of the
attachment area materials comprises selecting the attachment area
materials from a plurality of component parts.
21. The method of claim 13, wherein each of the attachment area
materials has a durometer adapted to permit a user to don and doff
the liner while the attachment area materials are attached to the
attachment areas.
22. The method of claim 13, further comprising the step of applying
an alignment indicator to the liner in such a way that a user can
align the alignment indicator to an anterior midline of the body
part.
23. The method of claim 22, wherein the alignment indicator
represents zero degrees, and the plurality of attachment areas
comprise four attachment areas circumferentially located
approximately at 45, 135, 225, and 315 degrees relative to the
alignment indicator.
24. The method of claim 13, wherein the liner is integrally formed
with the attachment area materials.
25. The method of claim 13, wherein the attachment area or
attachment area materials have a raised texture such that friction
is increased against the socket wall to resist or prevent slippage
of the liner with respect to the socket wall.
26. The method of claim 13, further comprising the step of donning
the liner and affixing the attachment area materials to the
attachment areas after the liner is donned.
27. The method of claim 13, wherein at least one of the plurality
of attachment areas comprises a hook or loop fastener material.
28. The method of claim 13, wherein the attachment area materials
are selected from a plurality of attachment area materials having
different durometers.
29. The method of claim 13, wherein the proximal end and distal end
of the liner are both open ends.
30. The method of claim 13, wherein at least one area between the
plurality of attachment areas is an open or low-compression
area.
31. A method of fabricating a socket for a limb using a liner
having a plurality of compression areas, the method comprising:
donning the liner on the limb such that the plurality of
compression areas compress soft tissue of the limb at target areas,
wherein the target areas (i) are longitudinally-shaped, (ii) have a
longitudinal axis that is substantially parallel to a longitudinal
axis of a skeletal structure within the limb, and (iii) are
disposed circumferentially around the longitudinal axis of the
skeletal structure; and casting or scanning the limb while the
liner is donned on the limb and the limb is in a compressed
state.
32. The method of claim 31, wherein the plurality of compression
areas are spaced circumferentially around the limb and at least one
area between the plurality of compression areas is an open or
low-compression area.
33. The method of claim 31, further comprising the step of creating
a virtual model of the limb in the compressed state.
34. The method of claim 31, wherein the compressed state of the
limb determines an internal volume of the socket.
Description
[0001] This application is a continuation of and claims the benefit
of priority from U.S. patent application Ser. No. 15/019,683, filed
on Feb. 9, 2016, which claims the benefit of priority from U.S.
Provisional Patent Application No. 62/115,142, filed on Feb. 11,
2015, which are incorporated by reference herein.
FIELD OF THE INVENTION
[0002] The field of the invention is skeletal stabilization liner
systems, and more particularly, methods of fabricating liners that
provide compression in target areas of a body part to reduce motion
of the skeletal structure towards a wall of a socket.
BACKGROUND
[0003] Traditional sockets utilize essentially a peripheral control
scheme, wherein prosthetic device control results from global
volume reduction and pressure on the entire residual limb. A
compression stabilized socket or HiFi.TM. Socket made by
biodesigns, Inc., applies significantly more compression than could
be done utilizing a global compression model and does so in
biomechanically optimized zones or target areas with alternating
tissue release zones in order to limit bone motion.
[0004] A target area and the synonymous term, "area of
compression," refer to an area of a residual limb selected by a
clinician for compression as disclosed in U.S. Pat. No. 8,656,918
and U.S. Pat. Application No. 20140121783, which are incorporated
herein in their entirety by this reference.
[0005] A target area is defined by an area of compression parallel
to the long axis of the major bone or bones of the residual
anatomy, running virtually the entire length of the bone in the
residual limb, ending just short of the bone ends, however, a
shorter target area can be selected in particular applications. In
circumstances where the length of the bone in the residual limb is
substantially shorter than the length of the residual limb, a
target area is selected so that it runs beyond the length of the
bone in the residual limb in order to apply compression to tissue
beyond the bone ends to supplement the association between the
physical movement of the bone and the resulting movement of the
socket by also capturing the motion of the tissue beyond the bone
ends.
[0006] The outside perimeters of such a target area are defined by
the need to provide open or low-compression relief areas outside
the area of compression so that the compression is not impeded by
the inability of the underlying tissue to flow or migrate sideways
away from the shafts of the aforementioned bone or bones (or away
from the compression ends at the proximal and distal ends of the
compression areas). Selection of a target area takes advantage of
the anatomical response such that tissue can be compressed against
bone just so far before further motion is impeded, if there is room
for the displaced tissue to move out of the way. By this process,
the clinician is able to establish optimal tissue compression,
which is a compression force against soft tissue overlying skeletal
structure such that lost motion between the compression stabilized
socket and the underlying skeletal structures is minimized without
causing discomfort to the wearer for a usable amount of time.
Optimal tissue compression also describes the supplemental
compression force desired when target areas extend beyond the
length of the bone for applications where the length of the bone in
the residual limb is substantially shorter than the length of the
residual limb.
[0007] Lost motion can be understood with reference to traditional
sockets. In traditional sockets, lost motion occurs when force is
applied between the socket wall and the underlying skeletal
structures of the wearer, as would occur as an amputee tries to
move the prosthesis as a whole. Lost motion occurs when the bone
moves towards the socket wall a substantial distance before
imparting force to the wall, causing a degree of disassociation
between the physical movements of the body part in the socket and
the resulting movement of the socket and attached prosthetic.
[0008] A "usable amount of time" is the amount of time a clinician
or wearer expects the wearer to wear a socket on a typical day or
for a planned activity.
[0009] Despite its advantages, a compression stabilized socket is
more costly to produce than a traditional socket because it
requires specialized training and equipment, and substantial time
and labor to create. In addition, the wearer's residual limb may
lose volume after the compression stabilized socket is fitted,
reducing the compression and bone control achieved by that
socket.
[0010] There are many different prosthetic liners used with
sockets. Some liners add material of the same or different
durometer to the liner during its fabrication (called a custom
liner) to increase the liners thickness, but every known example
cites comfort as the main reason for doing so, or the desire to
make tissue contact, for example, in a heavily invaginated scar
area, rather than bone control. As such, the number of thickened
areas and their location on these liners are not optimized for bone
control.
SUMMARY OF THE INVENTION
[0011] The Skeletal Stabilization Liner System ("SSLS") improves
the underlying bone control in a traditional socket, which a wearer
may have chosen because a compression stabilized socket is too
costly, or where a wearer prefers a traditional socket design, by
allowing clinicians to simply order and fit or retrofit a liner
using the principles of the invention. In this manner, the
clinician is able to achieve somewhat similar results to the use of
a compression stabilized socket, even when a traditional socket is
used, although the level of bone control may not completely match
the level of bone control that can be achieved with a compression
stabilized socket. The SSLS also allows the wearer of a compression
stabilized socket to adjust the compression of the socket to
account for loss of residual limb volume after fitting.
[0012] Unlike liners previously known, the SSLS is designed to
minimize bone motion using an external pocket or other attachment
area at a target area with which to affix a shim to the liner and
increase the liner's radial width at the attachment area, which in
turn causes the liner to compress underlying bone when the liner is
donned and used with a socket. Prior liners that have added
thickness do not have thicker areas specifically located to provide
bone control through added compression at target areas and
attachment areas dimensioned to provide for relief areas between
attachment areas and, thus, do not stabilize the skeletal
structures of the limb within the socket.
[0013] The SSLS can be worn over the limb and inside the
traditional or compression stabilized socket. In the case of a
traditional socket, the SSLS modifies the peripheral volume
compression so that enhanced compression is applied to target
areas. In the case of a compression stabilized socket, the SSLS
augments the compression to target areas to account for lost limb
volume. The clinician or wearer can also address other concerns
regarding inadequate compression identified after the compression
stabilized socket is fabricated. In one embodiment, four generally
longitudinally oriented, externally affixed pockets or receptacles
are located at and overlay attachment areas on the external surface
of the liner in areas associated with target areas of the residual
limb. In another embodiment, four generally longitudinally oriented
attachment areas, such as hook and loop strips, or Velcro.RTM.
strips, are located at and overlay attachment areas on the external
surface of the liner. In another embodiment, three attachment areas
may be sufficient to provide the desired bone control.
[0014] In one embodiment, at least one attachment area is oriented
along the longitudinal dimension of the liner in a discontinuous
configuration such that it comprises two or more sub-areas lined up
along the length of the attachment area to function as a single
attachment area. In another embodiment, two or more shims are
similarly aligned over a uniform or discontinuous attachment area
to function as a single shim. In yet another embodiment, a very
short attachment area is coupled with a shim of sufficiently longer
length so as to provide the desired bone control based on the
length of the shim, rather than the length of the attachment
area.
[0015] In a variation of either of the four attachment area
embodiments, the centerlines of the attachment areas are placed
circumferentially and approximately equally spaced apart at 90
degree increments from one another. In one application of this
embodiment, the clinician or user aligns the longitudinal midline
of the anterior surface of the residual limb to an alignment
indicator or a reference on the liner that is equal to 0 degrees,
and the SSLS is donned by the wearer so that the centerlines of the
attachment areas are at 45, 135, 225, and 315 degrees relative to
that alignment indicator or reference once the SSLS is on the
residual limb. It is to be appreciated that the particular anatomy
of a wearer or expectations of asymmetrical limb loads on a
particular limb will dictate the location of the wearer's target
areas. Therefore, the clinician may require the liner be fabricated
with attachment areas in different locations.
[0016] In one embodiment, the attachment area has a narrowest width
of at least approximately 4.7% of the limb circumference, but a
narrower width may be selected in particular applications. The
attachment area has a broadest width adapted to permit a plurality
of relief areas between each attachment area for displacement of
tissue of the residual limb.
[0017] In one embodiment with hook and loop strips overlaying
attachment areas, each attachment area is configured so that it can
receive or couple with a shim selected by a clinician or wearer
from an inventory of shims of varying length, width, thickness,
curvature, and shape. Once donned, each shim adds an additional
thickness to the attachment areas of the liner in order to increase
the compression normally provided by the socket and SSLS (without
shims) to a level that minimizes motion of the underlying bone. In
one embodiment, shims are manufactured with portions that snap-off
to allow the clinician to easily modify the shim shape (length or
width) to match a wearer's unique target area, even in the case
where a pre-selected SSLS has an attachment area that may be longer
or shorter than that wearer's corresponding target area. In still
another embodiment, the shims can be thermo-formed to add desired
curvature.
[0018] One shim embodiment is made of plastic, but other suitable
material may be used. A thermo-formed shim embodiment is made of
carbon composite, but other suitable material may be used. Yet
another embodiment of the shim is made of a sealed gel packet,
where the gel is made of silicone material, but urethane or other
suitable material may also be used. It is to be appreciated that
such gel material could also be enclosed directly into a pocket of
a SSLS embodiment and the pocket sealed, so that that the
attachment area is comprised of such gel material. In SSLS
embodiments where the shim or gel is of sufficiently low durometer,
the SSLS can be donned or doffed while the shim, gel, or gel packet
remains in the pocket or otherwise attached to the liner.
[0019] In another liner embodiment, gel is embedded directly into
the liner materials at the attachment areas to provide the
increased radial thickness desired for bone control.
[0020] In other embodiments, the gel or a low durometer shim is
permanently adhered to the inner surface of the liner at attachment
areas during fabrication, such as by placing the gel or a low
durometer shim on a positive model of the limb and fabricating the
liner over the top of the gel or shim and the positive model. In
another embodiment, attachment areas on the inner side of the liner
(the side facing the limb) allow the wearer to roll-on the liner
over gel packets pre-placed on the limb at target areas to achieve
the desired compression and bone control. In a variation of this
embodiment, shims of appropriate durometer are pre-placed on the
limb instead of gel packets. In embodiments where the inner side
attachment areas are pockets, the wearer can insert shims or gel
packets into the pockets prior to or after donning the socket
without requiring pre-placement on limb target areas. Where the gel
packets or shims have an appropriately low durometer, these inner
pocket embodiments can be roll-on liners even with the shims or gel
packets inserted before donning.
[0021] Whether embedded or contained in sealed gel packets, in some
embodiments the gel properties are variable or controllable when
subjected to temperature changes, shear forces, electrical charge,
or magnetic fields to cause the gel durometer or volume to change.
Increasing the volume of the gel is advantageous to increase the
radial thickness at the attachment areas when the limb is subjected
to shear loads, increased temperature after donning, or when
desired by the user or clinician (in the case of electrically or
magnetically controllable gels). Increasing the durometer of the
gel is advantageous for bone control because it causes the liner to
resist compressive forces on the liner between the limb and socket
and maintain radial thickness that might otherwise be reduced due
to the compressive force. Conversely, an embodiment with a gel
whose durometer decreases in response to high shear forces is
advantageous for donning a roll-on liner.
[0022] Gels with these properties are known in the art and include
shear-thinning, shear-thickening, magneto rheological,
electrorheological, and thermoresponsive gels.
[0023] The SSLS is suitable for use with pre-existing sockets.
However, where an SSLS will be used with a socket that has not yet
been fabricated, an embodiment of the SSLS can be used during the
casting process with or without the shims in order to set the
appropriate internal volume of the prosthetic socket when the
socket is fabricated. Similarly, the appropriate internal volume of
the prosthetic socket can be set using an embodiment of the SSLS
during a scanning process, such as when laser scanning the residual
limb to create a virtual solid model of the limb, again with or
without the shims. Use of a SSLS embodiment during casting or
scanning is advantageous because the socket volume may otherwise be
too small and the socket may not properly don if no SSLS was used
during the casting or imaging process. In other words, after the
wearer donned the SSLS on the residual limb, the wearer may have
difficulty sliding the fabricated socket over the residual limb and
SSLS.
[0024] Embodiments of the SSLS may be a traditional closed-ended
design, but other embodiments can be in an open-end sleeve
configuration. One embodiment of the SSLS is constructed of
elastomeric material, but silicone or other suitable materials can
be used. In embodiments with a pocket, the pocket material that is
attached to the liner to form the pocket can be made of elastomeric
material, fabric, silicone, or other suitable material. In one
pocket embodiment, the pocket opening for inserting the shim is
located on the proximal end of the pocket, but the pocket opening
can be in any location such that the shim can be inserted and
removed from the pocket.
[0025] In one embodiment, pocket material surrounds and adheres to
the liner to form a second liner layer and additional pocket
material attaches to the second liner layer to form one or more
pockets for one or more shims.
[0026] In an embodiment where an attachment area is made of hook or
loop fasteners, an embodiment of the shim also has at least one
shim face covered with corresponding hook or loop material, so that
it may be attached to the attachment area.
[0027] In other embodiments, the socket-facing surface of the shims
or pockets includes a raised texture such that friction is
increased against the socket wall to resist or prevent slippage of
the liner with respect to the socket wall. This raised texture
could be uni-directional such that it prevents rotation or
pistoning, or bi-directional, or multidirectional such that shear
in any direction is mitigated or reduced.
[0028] In some embodiments with pocket or hook and loop
attachments, the thickness of the pocket and hook and loop
attachment material or the underlying liner material is increased
in the attachment area so that the pocket or the attachment
material or underlying liner material provides some of the desired
compression to the wearer even when no shim is inserted or
attached. In one embodiment, the thickness of the liner is
increased in the attachment area by bonding an additional liner
material layer on top of the primary liner material that
constitutes the primary liner surrounding the residual limb after
donning. The additional liner material layer can be of variable
thickness to provide for tapering at the edges of this additional
material.
[0029] In another embodiment where the thickness of the liner is
increased in the attachment area without use of a shim, the liner
itself is molded or otherwise fabricated to be thicker in the
attachment areas, rather than by bonding an additional liner
material layer on top of the primary liner material. In a variation
of either this embodiment or the embodiment with the additional
liner material bonding, there is no mechanism for attaching shims
because the thickness manufactured into the liner is sufficient to
provide the desired bone control.
[0030] In other embodiments, bladders are affixed externally or
fabricated within the liner in the attachment areas such that the
radial thickness at the attachment areas can be increased as
bladder volume is increased using a hand pump coupled to each
bladder. The hand pump is detachable in these embodiments, but in
other embodiments, the hand pump could attach to a suitable
location on the liner or socket, once the socket is donned. It is
to be appreciated that a CO2 cartridge and regulator or an
automated pump could be substituted for the hand pump, and that
fluids other than air or CO2 could be used as the inflation
medium.
[0031] Besides the advantages already identified, the SSLS has a
number of other advantages over other known liners. For instance,
because embodiments of the SSLS liners can be produced in a variety
of customizable and formable shapes and configurations, these
embodiments can be sold as a product or kit with shims, so that the
SSLS is readily usable by clinicians and wearers to assemble a
customized liner. This ability to mass produce the SSLS means the
product can be produced at a significantly reduced cost as compared
to current customized solutions.
[0032] Another advantage of the SSLS is that, in some embodiments,
a clinician or wearer can alter the fit on the fly by simply adding
or subtracting shims, including doubling or tripling the number of
shims at an attachment area or, in still another embodiment,
utilizing shims of different lengths, widths, thicknesses,
curvatures, and shapes.
[0033] In a disposable embodiment, all or portions of the SSLS can
be manufactured with materials whose cost and fabrication make it
economical to dispose of these portions on a daily or monthly
basis.
[0034] In other embodiments, one or more sensors can be integrated
into or attached to one or more shims and be in wireless
communication with a smartphone or other computer device to provide
socket and SSLS fit information, such as localized pressure, during
all phases of the wearer's use of the socket. Similarly, in other
embodiments, one or more sensors could be attached to or integrated
into one or more attachment areas of the SSLS.
BRIEF DESCRIPTION OF THE DRAWINGS
[0035] FIG. 1 depicts an SSLS embodiment looking up from its bottom
end, at the distal end of the SSLS.
[0036] FIG. 2 depicts a cross-sectional view of another embodiment
of the SSLS, where the liner has affixed to its external surface
four longitudinally oriented, external pockets.
[0037] FIG. 3 depicts an inventory or kit of shims for an
embodiment of the SSLS from which the clinician or wearer may
select a shim or shims.
[0038] FIG. 4 depicts an embodiment of the SSLS in a traditional
closed-ended design.
[0039] FIG. 5 depicts an SSLS embodiment with a shim attached to
one of the attachment areas.
[0040] FIG. 6 depicts the SSLS embodiment inserted into a
compression stabilized socket, which is cut-away to show the SSLS,
including a shim mounted to the attachment area.
[0041] FIG. 7 depicts a top view of an SSLS embodiment showing the
open top.
[0042] FIG. 8 depicts an embodiment of the SSLS showing generally
longitudinally oriented attachment areas whose vertical placement
varies to align with respective target areas of a wearer once the
SSLS is donned.
[0043] FIG. 9 depicts an embodiment of a shim where a face of the
shim is covered with hook or loop fastener material to correspond
with the hook or loop fastener material used for an attachment
area.
[0044] FIG. 10 depicts an SSLS embodiment inserted inside an
open-cage compression stabilized socket so that the attachment area
affixed to the liner is aligned with one of the compression struts
and a shim is attached to the attachment area.
[0045] FIG. 11 depicts a cross-sectional view of an embodiment
where gel is embedded directly into the liner at the attachment
areas to provide the increased radial thickness desired for bone
control.
DETAILED DESCRIPTION OF THE INVENTION
[0046] FIG. 1 depicts an SSLS embodiment looking up from its bottom
end 13, at the distal end of the SSLS. The liner 11 in this
embodiment includes four longitudinally oriented attachment areas
10 made of hook and loop strips that are affixed to the external
surface of the liner in areas associated with target areas of the
residual limb.
[0047] FIG. 2 is a cross-sectional view of another embodiment of
the SSLS, where the liner 11 has affixed to its external surface
four longitudinally oriented, external pockets 21, also in areas
associated with target areas of the residual limb. The SSLS in FIG.
2 is also shown inserted in a socket 22.
[0048] In the embodiments shown in FIG. 1 and FIG. 2, the
centerlines of the attachment areas 10 are placed circumferentially
and approximately equally spaced apart at 90 degree increments from
one another. In one application of this embodiment shown in FIG. 4,
the clinician or user aligns the longitudinal midline of the
anterior surface of the residual limb with a reference line 43 that
represents 0 degrees, and the SSLS is donned by the wearer so that
the centerlines of the attachment areas are at approximately 45,
135, 225, and 315 degrees relative to the reference line once the
SSLS is on the residual limb and the reference line is aligned with
the midline of the anterior surface of the residual limb. It is to
be appreciated that the liner can have alignment indicators other
than a reference line that are also suitable for assisting the
clinician or user in aligning the liner attachment areas so that
the attachment areas are at approximately 45, 135, 225, and 315
degrees relative to the longitudinal midline of the anterior
surface of the residual limb.
[0049] In FIG. 1, the attachment areas have a narrowest width of
approximately 5.9% of the limb circumference, but a narrowest width
of at least approximately 4.7% of the limb circumference may be
selected, or narrower widths may be selected in particular
applications. In FIG. 1, the attachment areas have a broadest width
of approximately 8.5% of the liner circumference, but the
attachment areas may have a broadest width adapted to permit a
plurality of relief areas 15 between each attachment area for
displacement of tissue of the residual limb. The plurality of
relief areas 15 are also shown in FIG. 2.
[0050] Each attachment area is configured so that it can receive or
couple with a shim 12, as shown in FIG. 1 and FIG. 2. FIG. 3
depicts an inventory or kit of shims 31 from which the clinician or
wearer may select a shim. The shims in this inventory or kit vary
in length, width, and thickness, but the inventory may also include
shims of different curvatures, or shape. The shim embodiments
depicted in FIG. 3 are 1.6 and 2.4 mm thick (thickness not shown),
but shims of approximately 0.8 mm or larger would be suitable,
depending on the fit of the socket.
[0051] Once attached to an attachment area, each shim adds an
additional thickness to the attachment area of the liner in order
to increase the compression normally provided by the socket and
SSLS (without shims) to a level that minimizes motion of the
underlying bone. In the embodiment shown in FIG. 3, the shims are
manufactured so that portions easily snap-off at the curved lines
32 to allow the clinician to modify a shim length to match a
wearer's target area. In other embodiments (not shown), different
snap-off features allow the clinician to easily modify the shim
width, again to match the wearer's target area. In still other
embodiment (not shown), the shims can be thermo-formed to add
desired curvature
[0052] The shim embodiments shown in FIG. 3 are made of plastic,
but other suitable material may be used. A thermo-formed shim
embodiment (not shown) is made of carbon composite, but other
suitable material may be used. Yet another embodiment of the shim
is made of a sealed gel packet (not shown), where the gel is made
of a silicone material, but urethane or other suitable material may
be used. It is to be appreciated that such gel material could also
be enclosed directly into a pocket of a SSLS embodiment and the
pocket sealed, so that that the attachment area is comprised of
such gel material. In SSLS embodiments where the shim or gel is of
sufficiently low durometer, the SSLS can be donned or doffed while
the shim, gel, or gel packet remains in the pocket or otherwise
attached to the liner.
[0053] FIG. 11 depicts another liner embodiment where gel 16 is
embedded directly into the liner 11 at the attachment areas to
provide the increased radial thickness desired for bone
control.
[0054] Where an SSLS will be used with a socket that has not yet
been fabricated, an embodiment of the SSLS can be used during the
casting process with or without the shims in order to set the
appropriate internal volume of the prosthetic socket when the
socket is fabricated. Similarly, the appropriate internal volume of
the prosthetic socket can be set using an embodiment of the SSLS
during a scanning process, again with or without the shims.
[0055] FIG. 4 depicts an embodiment of the SSLS in a traditional
closed-ended design, but other embodiments can be in an open-end
sleeve configuration. FIG. 5 depicts an SSLS embodiment similar to
that in FIG. 4, but showing a shim 12 attached to one of the
attachment areas 10. FIG. 6 depicts the SSLS inserted into a
compression stabilized socket 61, which is cut-away to show the
SSLS, including a shim 12 mounted to the attachment area.
[0056] The embodiment of the SSLS depicted in FIG. 4 has a rigid
bottom 13, but non-rigid materials may also be used, or the bottom
may be a continuation, for example, of the liner 42 material and
attached at the distal end to form a sock-like configuration. The
embodiment in FIG. 4 is constructed of elastomeric material, but
other suitable materials could be used.
[0057] In the SSLS embodiment depicted in FIG. 4, the liner is open
at the top 14 or proximal end to receive the residual limb. FIG. 7
depicts a top view of this embodiment showing the open top 14.
[0058] FIG. 8 depicts an embodiment of the SSLS with a first
attachment area 81, a second attachment area 82, and third
attachment area 83, each approximately 90 degrees apart. These
attachment areas are generally longitudinally oriented, but their
vertical placement varies so that they are aligned with respective
target areas of a wearer once the SSLS is donned. For instance, the
first attachment area 81 is shorter and extends more distally than
the second attachment area 82.
[0059] In the embodiment depicted in FIG. 8, the shortest length of
the attachment area is approximately 35% of the liner length,
however, a shorter attachment area, such as 10% of the liner
length, or even shorter, can be selected in particular
applications, where the liner length means the finished length of
the liner as worn by a wearer and as generally depicted in the
drawings of this application. It is to be appreciated that liner
embodiments using very short attachment areas coupled with shims
with longer lengths, such as shim lengths that are 10% or more of
the liner length, would be within the spirit and scope of the
invention since in such embodiments it is the overall length of the
shim that primarily defines the length of the compression area.
[0060] In the pocket embodiment depicted in FIG. 2, the pocket 21
material that is affixed to the liner 11 may be made of elastomeric
material, fabric, silicone, or other suitable material. In this
embodiment, the pocket opening for inserting the shim 12 is located
on the proximal end of the pocket, but the pocket opening can be in
any location such that the shim can be inserted and removed from
the pocket.
[0061] In a variation of the embodiment depicted in FIG. 2, the
pocket 21 material surrounds and adheres to the liner 11 to form a
second liner layer (not shown) and additional pocket material
attaches to the second liner layer to form one or more pockets for
one or more shims 12.
[0062] FIG. 9 depicts an embodiment of the shim 12 where a face of
the shim is covered with hook or loop fastener material 91 to
correspond with the hook or loop fastener material used for an
attachment area 10 (shown, for example, on FIG. 1 and FIG. 4), so
that the shim may be attached to an attachment area.
[0063] In the embodiments depicted in FIG. 1 and FIG. 2, the
thickness of the hook and loop attachment area 10 material and the
pocket 21 material increases the attachment area thickness so that
the pocket or the attachment material provides some of the desired
compression to the wearer even when no shim is inserted or
attached. For example, in the embodiment shown in FIG. 1, the loop
strip is approximately 0.4 mm thick. In another embodiment (not
shown), the underlying liner 11 material may be fabricated or
modified to be thicker in the attachment area to provide the
desired compression to the wearer even when no shim is inserted or
attached.
[0064] In the embodiment shown in FIG. 4, the thickness of the SSLS
liner is increased in the attachment area by bonding an additional
liner material layer 41 on top of the primary liner 42 material
that surrounds the residual limb after donning. The additional
liner material layer can be of variable thickness to provide for
tapering at the edges of this additional liner material.
[0065] In other embodiments (not shown), one or more sensors can be
integrated into or attached to one or more shims 12 and be in
wireless communication with a smartphone or other computer device
to provide socket 22 and SSLS fit information, such as localized
pressure, during all phases of the wearer's use of the socket.
Similarly, in other embodiments (not shown), one or more sensors
can be attached to or integrated into one or more attachment areas
10 of the SSLS.
[0066] FIG. 10 depicts the SSLS inserted inside an open-cage
compression stabilized socket. In this embodiment, the attachment
area 10 is aligned with one of the compression struts 101, so that
a shim 12 can be attached to the attachment area affixed to the
liner 11, resulting in increased compression on the residual limb
as compared to if no shim were attached.
[0067] Liner Fabrication and Shim Use
[0068] An exemplary method for fabricating the liner for the SSLS
comprises selecting at least three attachment areas on a liner
lying along a longitudinal dimension of the liner, wherein the
longitudinal dimension runs from the distal end to the proximal end
of the liner, wherein each attachment area has a centerline,
wherein the selecting at least three attachment areas further
comprises: substantially aligning each centerline parallel to the
longitudinal dimension; spacing each attachment area centerline
circumferentially and approximately equally around the liner;
selecting a circumferential width of each attachment area in such a
way as to permit a plurality of relief areas between each
attachment area, wherein the liner has a minimum radial thickness;
selecting a length of each attachment area, wherein each attachment
area is adapted to extend at least approximately 10% the
longitudinal dimension; a) selecting a first attachment area
material; b) dimensioning the first attachment area material to
overlay a first attachment area; and c) affixing the first
attachment material to the liner in such a way as to overlay the
first attachment area to form a first enhanced compression area;
repeating steps a)-c) with additional attachment area materials and
the remainder of the attachment areas to form a plurality of
enhanced compression areas, wherein the plurality of enhanced
compression areas includes the first enhanced compression area,
wherein a maximum radial thickness of each of the plurality of
enhanced compression areas is at least 0.4 mm greater than the
minimum radial thickness.
[0069] It is to be appreciated that the step of spacing each
attachment area centerline circumferentially and approximately
equally around the liner may be adjusted by a fabricator to
accommodate the particular anatomy of a wearer or asymmetrical limb
loads expected during use, such as higher anterior and lateral
loads that a particular fabricator may anticipate for humeral
applications.
[0070] In a variation of this method, the first attachment area
material and the additional attachment area materials comprise
sealed pocket material, further comprises selecting a thickness of
the first attachment area material and the additional attachment
area materials in such a way as to prevent substantial movement of
a skeletal structure within the limb when the liner is worn with a
socket.
[0071] Besides using the exemplary method for fabricating the
liner, the liner can also be integrally formed by a variety of
molding processes, including casting, injection molding, extrusion
molding, thermoforming, and rotational molding,
[0072] It is to be appreciated that one skilled in the art can
embed additional liquid or solid materials or gels into the liner
at attachment areas in accordance with the invention using methods
known in the art to cause the thickness of the attachment areas to
be sufficiently greater relative to the thickness of the liner
outside the attachment areas, so that the liner provides the
desired bone control.
[0073] Additional steps for adding shims to the liner of the SSLS
comprise: a) selecting an enhanced compression area from the
plurality of enhanced compression areas; b) selecting a shim to
attach to the enhanced compression area, wherein the shim is
selected from an inventory of shims of at least one varying
dimension selected from the group consisting of length, width,
radial thickness, and curvature; c) attaching the shim to the
enhanced compression area, d) repeating steps a)-c) with additional
shims and the remainder of the plurality of enhanced compression
areas as necessary to prevent substantial movement of the skeletal
structure within the limb when the liner is worn with a socket.
[0074] In a variation of this method for adding shims, the step of
attaching a shim to the enhanced compression area comprises
attaching two or more shims to the enhanced compression area.
[0075] A variation of the exemplary method for fabricating the
liner comprises selecting the liner from a kit of component parts
comprising a variety of liner shapes and configurations.
[0076] In a variation of the method for adding shims to the liner,
the shim and the additional shims have a maximum durometer adapted
to permit a user to don and doff the liner while the shims are
attached to the liner.
[0077] A variation of the exemplary method for fabricating the
liner comprises: applying an alignment indicator to the liner in
such a way that the user can align the alignment indicator when
worn to an anterior longitudinal midline of the limb, wherein the
alignment indicator represents zero degrees, wherein the plurality
of enhanced compression areas number four and are circumferentially
located at 45, 135, 225, and 315 degrees relative to the alignment
indicator.
[0078] A second method for attaching shims to a liner such as the
liner fabricated according to the exemplary method described above
comprises: selecting a first shim; selecting a second shim, wherein
the first shim has a first thickness, wherein the second shim has a
second thickness; attaching the first shim to a first attachment
area chosen from the at least three attachment areas; attaching the
second shim to a second attachment area chosen from the at least
three attachment areas; and repeating the above steps with
additional shims and the remainder of the attachment areas as
necessary to prevent substantial movement of a skeletal structure
within the limb when the liner is worn with the socket, wherein the
first thickness, the second thickness, and the thickness of
additional shims are selected in such a way as to prevent
substantial movement of the skeletal structure within the limb when
the liner is worn with the socket.
[0079] If the shim durometers allow it, the user may attach the
shims before donning a socket or after donning a socket.
[0080] It will be apparent to those skilled in the art that changes
and modifications may be made in the embodiments illustrated and
described, without departing from the spirit and the scope of the
invention. Thus, the invention is not to be limited to the
particular forms herein shown and described except insofar as
indicated by the scope of the appended claim.
* * * * *