U.S. patent application number 10/107318 was filed with the patent office on 2002-08-01 for gel and cushioning devices.
This patent application is currently assigned to OHIO WILLOW WOOD COMPANY. Invention is credited to Arbogast, Robert E., Capper, James W., Colvin, James M., Doddroe, Jeffrey L., Kania, Bruce G..
Application Number | 20020103545 10/107318 |
Document ID | / |
Family ID | 24766478 |
Filed Date | 2002-08-01 |
United States Patent
Application |
20020103545 |
Kind Code |
A1 |
Arbogast, Robert E. ; et
al. |
August 1, 2002 |
Gel and cushioning devices
Abstract
Articles of apparel for an amputee's residuum and for
non-amputees who desire or require padding or joint support.
Inventors: |
Arbogast, Robert E.; (Mount
Sterling, OH) ; Capper, James W.; (Mount Sterling,
OH) ; Colvin, James M.; (Mount Sterling, OH) ;
Kania, Bruce G.; (Mount Sterling, OH) ; Doddroe,
Jeffrey L.; (Mount Sterling, OH) |
Correspondence
Address: |
OBLON SPIVAK MCCLELLAND MAIER & NEUSTADT PC
FOURTH FLOOR
1755 JEFFERSON DAVIS HIGHWAY
ARLINGTON
VA
22202
US
|
Assignee: |
OHIO WILLOW WOOD COMPANY
15441 Scioto Darby Road
Mount Sterling
OH
43143
|
Family ID: |
24766478 |
Appl. No.: |
10/107318 |
Filed: |
March 28, 2002 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10107318 |
Mar 28, 2002 |
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09131915 |
Aug 10, 1998 |
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09131915 |
Aug 10, 1998 |
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08688954 |
Jul 31, 1996 |
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Current U.S.
Class: |
623/36 ;
523/105 |
Current CPC
Class: |
A61F 2/80 20130101; A61F
2002/30324 20130101; A61F 2002/7818 20130101; A61F 2/78 20130101;
A61F 2210/0071 20130101; A61F 2002/3021 20130101; A61F 2002/30065
20130101; A61F 2/7812 20130101; A61F 2002/30069 20130101; A61F
2002/7831 20130101; A61F 2002/5007 20130101; A61F 2250/0036
20130101; A61F 2002/5055 20130101; A61F 2230/0067 20130101 |
Class at
Publication: |
623/36 ;
523/105 |
International
Class: |
A61F 002/80; C08L
001/00 |
Claims
What is claimed as new and desired to be secured by Letters Patent
of the United States is:
1. A covering for enclosing an amputation stump, said covering
having an open end for introduction of said stump and a closed end
opposite said open end, said covering having an inside and an
outside and comprising a foamed or non-foamed gel composition
having a Shore 00 durometer of from 1-100 and comprising a
styrene-ethylene/propylene, styrene-ethylene/butylene-styrene,
styrene isoprene/butadiene block copolymer or mixtures thereof and,
optionally, up to 90% by weight, of mineral oil based on total
weight of copolymer and oil.
2. The covering as claimed in claim 1, wherein said covering is a
sleeve member having a form fit shape, said gel having a thickness
profile such that the gel is thicker at the closed end of the
sleeve member than at the open end or vice versa.
3. The covering as claimed in claim 1, further comprising docking
means for attaching said covering to a prosthetic device.
4. The covering as claimed in claim 1, wherein said covering
further comprises fabric which coats part or all of said gel on at
least one side thereof.
5. The covering as claimed in claim 2, wherein said covering
further comprises fabric which coats part or all of said gel on at
least one side thereof.
6. The covering of claim 4, wherein said gel is partially or wholly
covered with fabric on both sides thereof.
7. The covering of claim 5, wherein said gel is partially or wholly
covered with fabric on both sides thereof.
8. The covering of claim 4, having fabric on the outside thereof
and further comprising said gel or a thermoplastic elastomer or a
thermoset elastomer on the outside of said fabric arranged so as to
be capable of forming an air-tight seal with a prosthetic hard
socket when worn by an amputee.
9. A covering for enclosing an amputation stump arranged in a
recessed achillies configuration.
10. A polymeric gel comprising 25-65 wt. % of a styrene
isoprene/butadiene block copolymer and 35-74 wt. % mineral oil and
having a Shore 00 durometer of from 1-100.
11. A reinforced covering for enclosing an amputation stump, said
covering having an inside and an outside and comprising a foamed or
non-foamed gel composition having a Shore 00 durometer of 1-100 and
a reinforcing material having an elasticity lower than said gel and
arranged in said covering so as to protect a wearer and/or said
covering from stress and/or abrasion when worn.
12. The covering of claim 11, wherein said gel is partially or
wholly covered on at least one side with fabric.
13. The covering of claim 11, said covering having a form-fit
shape.
14. The covering of claim 11, said covering having a tubular
shape.
15. An open-ended cushion sleeve for use by an amputee or
non-amputee, said open-ended sleeve being cylinder-shaped and
having an inside and an outside, said sleeve comprising a foamed or
non-foamed gel composition having a Shore 00 durometer of from
1-100 and comprising a styrene-ethylene/propylene,
styrene-ethylene/butylene-styrene or styrene isoprene/butadiene
block copolymer and, optionally, up to 90% by weight, of mineral
oil based on total weight of copolymer and oil.
16. The sleeve as claimed in claim 15, further comprising a
reinforcing material having an elasticity lower than said gel and
arranged in said sleeve so as to protect said amputee or
non-amputee and/or said sleeve from stress and/or abrasion when
worn.
17. The sleeve as claimed in claim 15, wherein said sleeve further
comprises fabric which coats part or all of said gel on at least
one side thereof.
18. The sleeve as claimed in claim 15, having said gel or a
thermoplastic elastomer or a thermoset elastomer arranged so as to
be capable of forming an air-tight seal with a limb or prosthetic
hard socket when worn.
19. The sleeve as claimed in claim 15, wherein the elasticity of
said sleeve is higher circumferentially than axially.
20. A cushioned fabric, comprising fabric coated with a foamed or
non-foamed gel composition having a Shore 00 durometer of from
1-100 and comprising a styrene-ethylene/propylene,
styrene-ethylene/butylene-styren- e or styrene isoprene/butadiene
block copolymer and, optionally, up to 90% by weight, of mineral
oil based on total weight of copolymer and oil.
21. A method for producing an article to be worn on the body,
comprising shaping a cushioned fabric comprising fabric coated with
a foamed or non-foamed gel composition having a Shore 00 durometer
of from 1-100 and comprising a styreneethylene/propylene,
styrene-ethylene/butylene-styrene or styrene isoprene/butadiene
block copolymer and, optionally, up to 90% by weight, of mineral
oil based on total weight of copolymer and oil, and connecting a
portion or portions of said cushioned fabric to itself, to another
shaped cushioned fabric, or to another material constituting the
article to be produced.
Description
BACKGROUND OF THE INVENTION
[0001] 1. Field of the Invention
[0002] The present invention relates to a gel and various articles
of manufacture such as a cushion liner with fabric on the inside
and/or outside thereof, cushion locking liner with added-on metal
threaded insert, open-ended cushion knee or elbow sleeve, cushion
fabric and cushion flat sheet all useful for increasing the comfort
of the wearer. Also described is a sleeve member, and reinforced
sleeve member for enclosing an amputation stump, preferably, a
cushioned sock for use by, e.g., below-knee (BK) amputees. The
sleeve member and cushioning devices are preferably provided in a
contoured form fit configuration which, when worn, comes up over
the knee or elbow and adapts to a right or left side bias of the
bony prominence of the residuum (stump) or are provided in simple
tube (i.e., tube-sock) shape with various optional cushioning.
Cushioning material may optionally be provided on the inside and/or
outside of the invention sleeves, liners and sheet to minimize the
discomfort of, e.g., an orthotic device, such as a knee brace, or a
prosthetic device, such as an artificial arm or leg. In a preferred
embodiment, the cushioning material is adjusted in thickness and
has a non-uniform thickness over the article surface. In another a
preferred embodiment the sleeves and liner have cushioning material
in a recessed achilles configuration: the cushioning material does
not contact the wearer at an upper posterior (i.e., knee crease),
or upper anterior (i.e., elbow crease, etc.) portion of the limb or
residuum, or minimally contacts the wearer at these positions,
while providing cushioning, etc. to the knee or elbow due, e.g., to
the thinning of cushioning material, even while the liner, sleeve,
etc. comes up over the joint. For example, the cushioning material
can be thinner in these areas than in other places. In special
applications, such as for Symes amputations, a thinner coating of
gel at the distal end of a sleeve or liner can be used.
[0003] 2. Discussion of the Background
[0004] For at least the past 80 years amputees have worn tubular
socks over their residual limb. Cotton, wool and cotton-wool blends
have typically been used. More recently, with the advent of
synthetic materials, nylon and other textiles, including some with
a measure of elasticity, have also been utilized.
[0005] In a typical below-knee (BK) prosthesis an amputee's stump
tends to "piston" in the socket: during ambulation the stump will
come up in the socket of the prosthesis until the attaching means
holding the prosthesis to the wearer cause the prosthesis to lift
with the stump. On the way down, air may be trapped between the
residuum and stump sock, or between the prosthesis socket and sock,
or between a socket liner and a sock.
[0006] With wool and cotton socks which tend to breathe and which
are not airtight this pistoning effect is not a major problem with
regard to the generation of sound effects. Since wool and cotton
tend not to tightly form fit a residuum, however, the amputee
typically packs a material around the residuum once it is placed
into the prosthetic device or adds additional socks to increase
thickness or puts on thicker socks in order to provide necessary
fit. However, for socks which do not breathe and which are made
from, e.g., polymeric material, a problem occurs when the residuum
pistons in the prosthetic device: terrific sound effects such as
sucking and gurgling noises are generated which are obtrusive and
inappropriate, often embarrassing the wearer. In addition, such air
pockets produce non-uniform pressures and loading discontinuities
on the skin, irritating it.
[0007] Finally, many amputees experience a swelling of the stump.
When the residuum is in a prosthetic socket the stump tends to
contract significantly, and when taken out of the socket the stump
tends to expand within minutes of removal. This expansion and
contraction of the residuum contributes to the development of air
pockets and the generation of obtrusive noises since a sock which
may have provided a comfortable fit on the expanded stump becomes a
loose fit with air pocket opportunities when the residuum is placed
inside the prosthetic socket. In addition, and over time, an
amputee's residuum tends to adjust in size, usually shrinking. As
these changes occur they increase the tendency for the pistoning
effect, described above, to occur. In addition to the embarrassment
caused by the sound effects generated by pistoning, cushioned socks
which allow or promote air pocket formation quickly wear out and,
if not replaced often, lead to lesions, etc. on the residuum.
[0008] Currently available cushioned residuum socks are tubular or
conical and do not provide a form fit on an amputee's residuum.
Regardless whether such socks are provided with internal and/or
external cushioning material they fail to avoid air pockets. While
a stump may generally have a roughly conical or cubical shape there
are invariably recessed areas on, e.g., the medial side of the
prominent tibia bone. Generally, on a below knee, left side
residual limb the recessed area will be predominantly on the right
side of the tibia bone. There is also typically a smaller recessed
area on the left side. For right side residual limbs the
predominant recessed area is on the left side of the bone, with
smaller recessed areas on the right side. Usually the greatest
recess occurs immediately below the patella, on either side. In
addition, left side amputees typically have a right side bias to
the bony prominence of the below knee stump, and right side
amputees have a similar bias to the left side. Conventional tubular
or conical elastic socks simply cannot account for these several
variable conditions without using extremely high levels of elastic
tension which compress the outer-most points along the stump's
circumference, causing discomfort and a non-uniform fit.
[0009] Amputees typically attach a prosthetic limb to their
residual limb by means of a rigid socket, liner, and a suspension
means. The rigid socket is often custom fabricated to match the
shape of the intended user's residual limb and may be made of
thermoplastic or fiber-reinforced thermoset materials, but can also
be made from wood, metal, etc. Since such hard materials are
generally uncomfortable when in intimate with the skin over long
periods of time, especially under load bearing conditions, liners
and/or prosthetic socks are often used as interface members between
the hard socket and the residual limb to increase comfort. Such
liners are generally of the open cell foam type, such as Pelite or
Kemblo, but may also be made of silicon, urethane, etc. type
materials. See, for example, U.S. Pat. Nos. 5,258,037 and
5,376,132, both incorporated herein by reference. Prosthetic socks,
as mentioned above, may be made of wool, cotton, synthetic
materials, etc, and amputees tend to prefer liners and socks which
are easily changed to facilitate cleaning, to accommodate volume
changes in the residual limb, or to accommodate different user
activities.
[0010] Suspension systems which help to hold a prosthetic limb in
place may or may not be an integral part of the rigid socket and/or
liner. Examples of suspension systems include supracondylar or
waist belt, joint and corset systems, neoprene or latex sleeves,
socket ears which grip the condyles, suction or pin and lock
systems such as those where the pin is attached to a liner and the
lock is attached to a hard socket, etc. Examples of typical
suspension systems may be found in U.S. Pat. No. 4,923,474, No.
4,923,475, No. 5,007,937, No. 5,108,456, No. 5,201,773, No.
5,201,774, No. 5,246,464, No. 5,263,923, No. 5,314,497, No.
5,387,245, No. 5,376,131 and No. 5,405,405, all incorporated herein
by reference.
[0011] However, and as is clear from the above description of the
prior art, all current interfaces for use between an amputee's
residual limb and a prosthetic device suffer from drawbacks which
may include custom fabrication (and corresponding long lead times),
high cost, low durability, space requirements (too long, too high
profile, etc.), noise due, for example, to air pockets forming
between the liner and the residual limb, skin irritation,
restricted joint range of motion, lack of accommodation of stump
geometry changes, objectionable odors, discoloration, inadequate
comfort, etc.
SUMMARY OF THE INVENTION
[0012] Accordingly, one object of this invention is to provide a
gel which can be used alone or in combination with various other
materials such as fabrics and which can be used in or formed into
various articles of manufacture, apparel, etc., and used by an
amputee and non-amputee to provide increased comfort.
[0013] Another object of the present invention is a cushion liner
which can fit a range of residual limb sizes with minimal or no air
pockets and which comprises, preferably, the invention gel with or
without fabric, preferably having a non-uniform thickness
throughout.
[0014] Another object of the present invention is a cushion locking
liner similar to the invention cushion liner but having docking
means preferably at the distal end or side thereof for coupling the
liner to, e.g., the hard socket of a prosthetic device. The docking
means are preferably molded directly into the cushion liner.
[0015] Another object of the present invention is an open-ended
cushion knee or elbow sleeve which is open on both ends and, when
worn by an amputee, can cover the residual limb and prosthetic
device so as to provide increased support for the prosthetic
device, or a seal for a suction suspension system, - and when worn
by a non-amputee provides padding or joint support or protection
from environmental elements. Gel alone or fabric/gel composites in
tube shape are preferred. For use as a seal the invention sleeve
can be worn over invention socks, closed-ended sleeves, fitted
sleeves, etc.
[0016] Another object of the present invention is to provide a
cushion flat sheet which is made of gel, of gel and fabric, or of
gel and another material which can be used to make any of the
invention cushion liners, cushion locking liners, cushion knee
sleeves, cushioned socks, etc., and which can be used in other
applications where padding is required including shoe inserts,
support bracing, seat cushions, sports pads for the knee, shin,
elbow, chest, hand, etc., crutch arm pads, etc. The invention
cushion flat sheet can also be used as a compression wrap, etc.
[0017] Another object of this invention is to provide a novel
optionally cushioned sleeve member for enclosing an amputation
stump having a form-fitting tubular shape.
[0018] Another object of the present invention is to provide an
optionally cushioned sleeve member having a bias pattern and
contoured form fit which will equally accommodate a left side
amputee and a right side amputee.
[0019] Another object of the present invention is to provide a
cushioned sock, liner, or locking liner having a contoured form fit
shape and polymeric cushioning material arranged to provide an
interface between an amputee's residuum and a prosthetic
device.
[0020] Another object of the present invention is to provide a
non-cushioned sleeve member having a contoured form fit.
[0021] Another object of the present invention is to provide a
cushioned sleeve member for enclosing an amputation stump having a
contoured, form-fitting tubular shape wherein, preferably, the
interior of the closed end of the sleeve member which if fabric, is
impregnated with or coated with a polymeric material arranged in a
recessed achilles configuration which provides a cushioning effect
at the interface between the residuum and a prosthetic device
socket but which minimizes or eliminates contact with the skin in
the crease of the knee or elbow or ankle, even while coming up over
those joints when worn. The form-fitting sleeve member can be made
of invention gel only or thermoplastic only also while still having
a recessed achilles configuration.
[0022] Another object of the present invention is to provide a
cushioned sleeve, open-ended sleeve, sock, liner or locking liner
which allows for the timed-release of a skin conditioner, biocide,
etc.
[0023] Another object of the present invention is to provide a
cushioned sleeve for an amputation residuum which is form fitting
and which avoids the generation of air pockets and the obtrusive
noises they provide.
[0024] Another object of the present invention is to provide a
sleeve member for enclosing an amputation stump which is form
fitting and which is optionally cushioned, which is as thin as
possible.
[0025] Another object of the present invention is to provide a
sock, including typical prior art tube socks, etc., having
cushioning material on the inside thereof in a recessed achilles
configuration.
[0026] Another object of the present invention is a reinforced
sleeve member, cushion liner, cushion locking liner, knee sleeve,
and all other invention articles, having a reinforcing material at,
e.g., the distal end thereof or in any other location desired such
as stress points, surfaces subjected to abrasion, etc.
[0027] Another object of the present invention is a cushion liner
with fabric on both the inside and outside surfaces thereof.
[0028] Another object of the present invention is the provision of
a seal on the exterior and/or interior of all invention articles,
preferably the invention cushion liner, wherein the fabric or gel
surface of an invention sock, sleeve, etc., is provided with an
elastic, air-tight-forming seal in the form of a band, etc. on the
outside and/or inside thereof. The seal is preferably made of the
invention gel, silicone, thermoplastic, etc.
[0029] Another object of the invention is to provide a cushioned
fabric which can be used to form any article that contacts the
body.
BRIEF DESCRIPTION OF THE DRAWINGS
[0030] A more complete appreciation of the invention and many of
the attendant advantages thereof will be readily obtained as the
same becomes better understood by reference to the following
detailed description when considered in connection with the
accompanying drawings, wherein:
[0031] FIG. 1 shows a typical pattern for the reflected two-piece
form fitting sleeve member according to the invention.
[0032] FIG. 2 shows frontal (A) and side views (B) of the invention
sleeve member enclosing a stump-like form, where 1a and 1b refer to
pattern members a and b, respectively, in FIG. 1.
[0033] FIG. 3 shows a typical pattern for the optionally banded
three-piece form fitting sleeve member according to the invention,
piece (a) being optional on the FIG. 3 pattern. Piece (a) can also
be used in the FIG. 1 pattern to provide a top band.
[0034] FIG. 4 shows an invention sleeve member assembled from the
FIG. 3 pattern, where a, b and c correspond to patterns a, b and c,
respectively, in FIG. 3.
[0035] FIG. 5 shows a cushion liner according to the present
invention with uniform wall thickness.
[0036] FIG. 6 shows a cushion liner according to the invention
having a tapered wall thickness at the open end.
[0037] FIG. 7 shows side and front views of an invention cushion
liner which has a contoured inner surface providing variable
thickness cushioning material at portions of the liner intended to
provided particular selective cushioning to the user.
[0038] FIG. 8 shows an invention open-ended cushion knee or elbow
sleeve with optional fabric covering and with optional thinning at
both ends.
[0039] FIG. 9 shows an invention locking liner with docking means
at the distal end thereof.
[0040] FIG. 10 shows an invention form fitting sleeve having an
optional window of clear plastic material, etc., in the fabric.
[0041] FIG. 11 shows an invention open-ended knee or elbow sleeve
in position and contacting a cushion liner and a prosthetic
device.
[0042] FIG. 12 shows a cushion locking liner with reinforcement.
The threaded insert is molded in.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0043] U.S. application Ser. Nos. 08/406,145 and 08/611,305 are
incorporated herein by reference. The present invention polymeric
gel composition comprises, preferably, a block copolymer and,
optionally, mineral oil. The gels of the invention are nonfoamed or
foamed with, e.g., a foaming agent. The mineral oil may be present
in from 0-90% by weight based on total gel weight, more preferably
20-50% by weight, but also including all of any positive amount
including 5, 10, 15, 20, 25, 30, 35, 40, 45, 55, 60, 65, 70, 75 and
80% by weight and all values and ranges in between all these listed
values. The invention gel preferably has a durometer (Shore A) of
0-20 and preferably a durometer that matches or approximates
(.+-.10%) human skin. Preferably, the oil is present on an equal
weight basis, or in a weight ratio of {fraction (1/4)}, with regard
to the amount of polymeric material present. More preferably, the
gel durometer is from 1-100 Shore 00, most preferably 5-35. The
polymeric material present is preferably a styrene
isoprene/butadiene block copolymer or
styrene-ethylene/butadiene-styrene block copolymer. Preferable
examples of such polymeric materials useful herein include C-Flex
1970-W5 (R70-339-000), C-Flex 1960-W5 (both manufactured by
Consolidated Polymer Technologies, Largo, Fla., U.S.A.) and Kraton
G1654 (manufactured by Shell Chemical Co.). For the C-Flex
materials a particularly preferred ratio is 1 part oil per 2 parts
C-Flex material.
[0044] Preferred ratios of polymer to mineral oil are 1/1-4/1 using
C-Flex 1970-W5 or 1960-W5, one part Kraton G1654: 2.75 parts
mineral oil, and 14 parts Kraton G1654: 15 parts C-Flex R70-306 (or
R70-190 or R70-251 or any mixture thereof): 40 parts mineral oil.
The C-Flex R70-339-000, R70-306, -190 and -251 materials are also
preferred herein and are products of Consolidated Polymer
Technologies. They are blends of S-EB-S block copolymer or SIB
block copolymer with mineral oil. 10 parts Kraton G1654 and 11
parts C-Flex R70-306 and 27 parts Duoprime 70 oil is also
preferred. A highly preferred gel is 62.5% C-Flex 1970-W5, and
37.5% Carnation mineral oil. 55-65% C-Flex 1970-W5 and 45-35% oil
is also preferred. Also preferred is a composition of 26-65%
styrene-isoprene/butediene block copolymer and 35-74% by weight
mineral oil. Here, 27, 28, 29, 30, 35, 40, 45, 50 and 55 wt % SIB
can be used with oil ranging from 73, 72, 71, 70, 65, 60, 55, 50
and 45 wt %. All %'s are percent by weight unless otherwise
indicated.
[0045] The preferred polymers useful herein and listed above
(C-Flex and Kraton materials), in addition to being
styrene-isoprene/butadiene or styrene-ethylene/butadiene-styrene
block copolymers (mixed with mineral oil in the case of at least
the C-Flex 1970-W5, R70-339-000, R70-306, -190 and -251 materials)
also include styrene-butadiene-styrene and any thermoplastic
elastomer having the Shore A and/or Shore 00 characteristics listed
above and capable of being blended with mineral oil. Mixtures of
all mentioned polymers may be used. Several preferred polymeric
materials useful in all aspects of the present invention are more
particularly described with regard to the invention sleeve member
infra.
[0046] The mineral oil used herein is preferably purified mineral
oil and is preferably USP grade. Carnation mineral oil is
preferred.
[0047] The present invention cushion liner and cushion locking
liner may have an overall tube-sock shape or may be form-fitting
(described more fully below with regard to the invention sleeve
member). These shapes are referred to generically as sock-shaped
coverings. The invention sleeve cushion liner and cushion locking
liner can fit a range of residual or normal limb sizes with minimal
or no air pockets, come up over the knee or elbow when worn, and
preferably have a range of elasticity of from 10-2400% and a range
of distal radius of {fraction (3/4)}"-4" or whatever is required by
the wearer. The invention sleeve, open-ended sleeve, cushion liner
and cushion locking liner may be made of the invention gel itself
or of a combination of gel/fabric with appropriate seaming, where
necessary. At least three standard geometries may be provided for
both the invention cushion liner and cushion locking liner, those
geometries being 1) uniform wall, 2) tapered wall and 3) contoured
wall. These geometries are also useful with regard to the invention
sleeve and open-ended sleeve member discussed below and refer to
the thickness of the gel. Recessed achilles configuration (see
infra) can be used in all articles and aspects of the invention, as
can a reverse taper of gel thickness where gel is thin at the
distal end and thicken towards the open end.
[0048] The uniform wall cushion and cushion locking liner simply
comprise a uniform thickness of gel. Tapered wall cushion liners
and cushion locking liners are generally those having a layer of
gel which is thicker distally for additional padding (and because
most shrinkage of the residual limb occurs at this point of the
limb) and thinner proximally (near the open end of the liner) to
blend in and interface more easily with the residual limb or vice
versa for, e.g., Symes amputations. Contoured wall cushion liners
and cushion locking liners have uneven distribution of gel
throughout to provide cushioning effects where needed and, in a
preferable embodiment, have a thinner posterior middle and upper to
allow maximum range of motion optionally with a thicker distal end
both anterior-medial and anterior-lateral with less thickness in
the region between these two areas so as to pad typical bony
promenances. Contoured wall liners are often thicker distally and
custom shapes can easily be provided to satisfy the individual
user. For example, in the liner of FIG. 7, the hatched area has a
gel or polymeric material cushion thickness of 13 mm, the dotted
portion 11 mm, the front of the liner 9 mm and the portion for
behind the knee less than 9 mm.
[0049] For both the invention cushion liner and cushion locking
liner combinations of gel with fabric include gel with a two-piece
or three-piece form-fit sleeve (described below). Other
configurations include gel coating inside a tube-sock fabric
form.
[0050] Foamed or nonfoamed thermoplastic elastomers or rubber only
can also be used as cushioning material alone or in combination
with the invention gel in all the articles of the invention. The
term "thermoplastic elastomers" has its typical meaning and
excludes the invention gel. Thermoset elastomers such as silicones
can also be used. The foamed materials can exclude mineral oil. The
inclusion of thermoplastic elastomers in the invention gel (the
mixture optionally being foamed) is advantageous in making the
products customizable since such products will tend to take the.
shape of a limb or model of a limb when, e.g., heat and/or pressure
are applied. In a preferred embodiment the invention gel can be
foamed and used alone or in combination with fabric in all forms of
the invention including the sleeve member (open-ended or closed),
in the form of a tube-sock, etc.
[0051] In addition, in the present invention articles of
manufacture including the cushion liner, cushion locking liner,
cushion knee sleeve, cushion flat sheet and sleeve member,
transducers can be included therein to sense pressure, force,
temperature, etc., to detect and/or transmit a signal from the
residual limb to a prosthetic device, to send myoelectric signals,
etc. In addition to transducers, any electrical device or other
sensing device can be similarly incorporated for detection, signal
transduction, etc. See, for example, U.S. Pat. No. 5,443,525,
incorporated herein by reference.
[0052] As mentioned above, the invention cushion locking liner
comprises docking means for attaching an external device, etc. to
the liner. Such docking means includes pins, etc. and are typically
those which help to attach and support a prosthetic device. These
docking means are known in the art and are preferably incorporated
in the cushion locking liner by means of direct molding, meaning
the molding of an adapter into the fabric possibility by injection,
compression, etc. molding, etc. using, preferably, urethane such as
an 80 Shore A urethane (Smooth-On PMC-780) after the gel is molded
to the fabric. See FIG. 12. Such docking means, including distal
inserts, can be centered or can be offset to accommodate individual
residual limb geometries. Other docking means include molding a
raised configuration in the side of the liner which then mates with
a recess on the inside of the prosthetic socket, allowing for a
locking effect when the user dons the liner and steps into a socket
as well as attaching one or more cables, etc., to the liner which
are then drawn through the bottom of the socket.
[0053] The invention open-ended cushion knee or elbow sleeve (also
referred to herein as cushion knee sleeve or knee sleeve, etc., for
brevity) is intended to be worn by an amputee and provide an
interface between the residual limb and a prosthetic device, and is
worn external to both or may be worn by a person whose limb is
intact but desires or requires padding or joint support. The knee
sleeve is generally cylinder- or band-shaped and covered on the
exterior with fabric and coated on the inside-with invention gel.
The interior may be further lined with fabric. The sleeve can be
any size but typically is from 1-25 inches long including 10, 15,
16, and 20 inches, and any diameter (unstretched) such as 1-10
inches, including 2, 31/2, 4 and 5 inches. Fabric may cover the
middle section of the interior, or all or any part of the interior,
if desired. The cushion knee sleeve itself may have a conical
(i.e., tapered) shape with a smaller diameter distally than
proximally or smaller diameter distally and proximally as compared
to a central diameter so as to grip and hold the prosthetic device
or residuum at the smaller diameter end(s). The interior gel
coating can be thinner at either or both of the distal and proximal
end, and can be thinner or absent in the back of or whole of the
middle section thereof so as to not bind in the crease of the knee
or elbow when worn by the user. It is preferred that the wall
thickness of the gel be thin at the ends regardless whether there
is fabric covering or sandwiching the gel or whether the exterior
or whole cushion knee sleeve is made simply of gel. itself. It is
also preferred that the circumfential elasticity be relatively high
as compared to relatively low axial elasticity.
[0054] The gel and/or thermoplastic used in all invention articles
is preferably provided such that the surface that contacts the
wearer or hard socket, etc., is substantially smooth, meaning the
type of surfaces depicted in the Figures and provided by dip coat
application, melt coating and solvent evaporation coating of the
gel or thermoplastic on the fabric.
[0055] The invention cushion knee sleeve can be used in combination
with the invention sleeve, cushion liner or cushion locking liner
as a means for suspension of a prosthetic device, or can be used
alone. In addition, the invention knee sleeve can have attached
thereto, by molding into the gel, by attachment means such as pins,
etc., an orthotic knee joint and optional support bars such that
the sleeve constitutes a knee brace. Similar arrangement may be
used for elbow braces.
[0056] All the invention articles such as the (closed-ended) sleeve
and liners can be provided with gel or thermoplastic on the outside
thereof so as to come in contact and provide increased friction
with the interior gel of the cushion knee sleeve. Such a
configuration provides additional support and suspension of the
prosthetic device. In addition, all the invention articles can be
provided with an elastic, air-tight-forming band on the inside
and/or outside which can form a seal for a suction suspension
system.
[0057] The present invention sleeve member for enclosing an
amputation stump overcomes the problems encountered with prior art
tubular or conical socks which are either prone to air pocket sound
effects or are so constricted as to be uncomfortable by providing a
sleeve member which is made in the shape of or from a pattern and
comprises the invention gel, a textile material, combination
thereof, elastomer, or textile material with other elastomer which
provides elastic tension such that the sleeve member form fits an
amputee's residuum. This combination of sleeve pattern in the form
of gel, or gel and textile material or textile material alone, etc.
provides a sleeve member having a comfortable feel and avoiding the
generation of obtrusive sounds which are directly traceable to the
presence of air pockets between a sleeve member and an amputee's
residuum or between sleeve member and prosthetic socket.
[0058] In all aspects of the invention described herein, the
elasticity of the fabric and/or gel and/or elastomeric material is
preferably sufficient to accommodate the swelling or shrinkage of
the residual limb typically experienced by an amputee and still
maintain an intimate fit. The preferred sleeve of the invention
including form fit sleeve has enough elastic compression to form
fit a stump but is not so tight as to be considered a stump
shrinker, as in U.S. Pat. No. 4,840,635 incorporated herein by
reference. Alternatively, invention articles can be tailored to
provide sufficient pressure to reduce swelling after
amputation.
[0059] FIG. 1 depicts a typical pattern from which the present
invention form-fitting sleeve member is constructed or shaped into.
The pattern is a reflected two-piece pattern, one piece of which is
designed to cover the bony prominence of a typical BK stump and
come up over the knee, (FIG. 1a) the other piece joined to the
first at the edges thereof and circumscribing the typical onset of
soft tissue around the stump (FIG. 1b). The two patterns can be
used to cut out two or more pieces of textile material which are
brought together such that the "X" on each of the patterns in FIGS.
1a and 1b are in contact with the "X" on the other pattern,
followed by the sewing together of the edges of each pattern in
typical fashion. When the two pieces are sewed together, a sleeve
member is provided which has a form fitting residuum-like (tubular)
shape having an open end into which an amputation stump may be
introduced, a closed end opposite to the open end, an interior and
an exterior. The two-piece pattern may be cut out of the same
textile material or different textile materials, and the two pieces
of textile material may have the same color or different colors.
The three-piece optionally banded reflected pattern of FIG. 3 also
provides a form-fit sleeve, piece (a) being optional. While the two
and three piece design are preferred because they do not require
specialized equipment for manufacturing the same form fitting
sleeve members can be made in a single piece with knitting
equipment or by molding with a polymeric material such as the
invention gel, thermoplastic, etc. In the case of a product made of
invention gel alone, thermoplastic alone or combination thereof,
the gel is shaped into the patterns depicted in FIGS. 1 and 3 by
art-accepted means using molds, etc.
[0060] The form fit sleeve of the invention can be made from
fabric, gel, elastomer, and combinations thereof according to the
patterns in FIG. 1 or FIG. 3. In FIG. 1a the distance A-B divided
by the distance B-C generally varies from {fraction (2/1)} to
{fraction (1/2)} and is preferably about {fraction (1/1)}. The
width of the pattern in FIG. 1a at point B divided by the width at
point C is generally approximately from {fraction (1/4)}-{fraction
(1/1)}, preferably about {fraction (1/2)}. In FIG. 1b the distance
A-C divided by the distance B-C is generally preferably about
1.05-1.3, most preferably about 1.1. In both patterns of FIGS. 1
and 3 the dimensions may be varied so as to provide a comfortable
form fit that avoids air pockets.
[0061] The two or more pieces of textile material used to form the
invention form fitting sleeve member can be sewn together using any
type of thread and any type stitch. This is also true for tube-sock
shaped articles. In a preferred embodiment, woolly nylon is used to
interconnect the two-piece or three-piece form-fitting sleeve
member of the invention or seam the tube-sock using a flat-locked
stitch, which is a stitch well known to those in the art. This
flat-locked stitch tends to create a smooth, non-irritating seam
having a stretch comparable to jersey fabric.
[0062] The size of the sleeve member according to the invention can
be varied depending upon the residuum to be enclosed by simply
proportionally reducing or enlarging the pattern, as desired. The
term "form fitting" residuum-like (tubular) shape as used herein
refers to the shape of the invention sleeve member which provides a
contoured fit on an amputation stump, which substantially reduces
or eliminates air pockets during pistoning of the amputation stump
in a prosthetic socket and which is obtained by providing a sleeve
member composed of two or more pieces of fabric having the pattern
described in FIG. 1 or FIG. 3 and/or comprised of invention gel
and/or other elastomeric material in the shape provided by these
patterns. Residuum-like configuration is further achieved via a
bias molding technique that replicates contours of a normal
amputation stump.
[0063] The fabric-containing articles according to the present
invention may be made with any textile material having any
thickness (ply). Preferred textile fabrics are those having
elasticity, including elasticities of 10-400%, such as stretchable
non-wovens (e.g., the Xymid.RTM. line of fabrics including
Wearforce.RTM. fabrics from DuPont which connect bulkable yarns
with non-woven sheet substrates), Lycra.RTM. comprising segmented
elastomeric polyurethane fibers (spandex), supplex nylon (an
engineered nylon textile fabric with a cotton-like texture and
appearance), neoprene fabrics (polychloroprene fabrics), nylon,
spunbonded olefin, looped nylon, spunlaced fabrics, polyester,
aramid fiber fabrics, etc. However, any textile material may be
used such as those described in Textiles, fourth edition, N. Hollen
et al, MacMillan, New York, 1973, The Modern Textile Dictionary
Duell, Sloan and Pearce, New York, 1963 and Dyeing Chemical
Technology of Textile Fibers, Trotman, E., Charles Griffin and Co.,
London, 1975, all incorporated herein by reference. The fabrics
used to make the invention articles are preferably elastic and are
preferably jersey knit but include all woven, knitted and non-woven
textile fabrics. In addition to those mentioned above and described
in the above-mentioned references, those described in Volume 22, p.
762 ff and Vol. 16, p. 72 ff of the Kirk-Othmer Encyclopedia of
Chemical Technology, Wiley, New York, 1983 and 1981, respectively,
are also included, both of these references being incorporated
herein by reference. Mixtures of types can be used with seaming
where necessary.
[0064] Preferred fabrics include mixtures of the above-mentioned
fabrics, such as a fabric of neoprene, 88% supplex nylon/12% lycra
spandex, 85% nylon/15% lycra spandex, 94% polyester/6% lycra
spandex. Such mixed fabrics may be uniformly mixed or may have one
type of fiber or predominantly one type of fiber on one face
thereof. For example, in those fabrics described above which
contain lycra, the lycra can be mixed throughout, can make up the
entire or substantially the entire face, or the entire or
substantially the entire back of the fabric once it is arranged in
an invention article.
[0065] The textile fabrics used in the invention may be
treated/finished in any manner known in the art. For example, a
nylon tricot surface may be applied to the textile fabric, etc. The
finishing need not be uniform over the entire invention article.
The article may be selectively treated at, for example, above the
knee (or elbow) portions, and with the same treatment, no treatment
or another treatment being present below the knee or elbow.
Similarly, treatment on the outer surface of the invention sleeve
member may be different from that on the inside thereof.
[0066] The textile material used to make the invention articles is
preferably elastic (stretchable) in one or more, preferably two,
directions and is capable of adjusting to variations in form and
size of the residuum or limb. In a preferred embodiment, a nylon,
neoprene, looped nylon combination provides excellent comfort and
durability. Preferred thicknesses of the invention textile material
range from 0.010 in-0.200 in, preferably 0.025 in to 0.125 in, all
values and all ranges therebetween. Typically the thicknesses of
patterns pieces in FIGS. 1 and 3 are the same, but need not be.
[0067] The sleeve member according to the invention is preferably a
cushioned sleeve member, that is a sleeve member having a form
fitting shape with an open end into which an amputation stump may
be introduced, a closed end opposite to said open end, an interior
and an exterior, wherein the interior at the closed end is
impregnated with a polymeric material arranged so as to provide a
cushion between the amputee's residuum and any prosthetic device to
be worn, attached to, etc. the residuum. The cushioning material is
preferably a polymeric material, most preferably the invention gel
and/or a thermoplastic elastomer (referred to simply as
thermoplastic herein) such as a thermoplastic rubber, silicon
containing elastomer, etc. which provides an interface between the
residuum and a prosthetic device but which does not contact or
minimally contacts the skin at the back of the knee or elbow or
ankle when worn by an amputee (recessed achillies), even though the
sleeve member, when worn, comes past the knee or elbow and contacts
the thigh or forearm. This cushioning material may also here and in
other articles of the invention be a thermoset silicone. This
cushioning material is thus provided in a "recessed achilles"
arrangement which avoids the irritation occurring in the crease
behind a knee or elbow provided by prior art cushion sleeves by
thinning or eliminating cushioning polymeric material at this
location. If the form fit sleeve is to be worn by an above-knee
amputee the recessed (thinned or absent) portion of the cushion
material may be arranged medially at, e.g., the perineum for
increased comfort. The interior of the sleeve member may also be
lined with fabric so no thermoplastic or less thermoplastic
contacts the skin. In fact, in all thermoplastic-fabric embodiments
herein, an inner fabric liner may be used to provide a
fabric-thermoplastic (gel)-fabric sandwich structure. Embodiments
which can be made of gel (thermoplastic) only can have an interior
fabric liner.
[0068] In a particularly preferred embodiment of the invention, all
articles including the sleeve member, knee sleeve, etc. can be
reinforced by an external and/or internal reinforcing material, in
any shape desired, preferably in the shape of a tubular cap or
dome, attached at any point where reinforcing is desired including
the distal end of invention sleeves, the joint portion of knee and
elbow sleeves, etc. The reinforcing material is preferably less
stretchable than the invention gel and thermoplastic used in the
particular invention article, and is most preferably knitted nylon
or Kevlar.RTM.. The reinforcing material is placed on the invention
articles (such as over the sleeve member end) and temporarily
secured preferrably by spray adhesive and permanently secured if
desired. For example, stitching, permanent gluing, etc. can be
used., before the gel and/or thermoplastic cushioning is added. The
reinforcing material may be arranged on the inside, outside, or
both, of the invention articles. In addition, it may constitute an
integral part of the invention article, such as a section of
reinforcinng material replacing part of the gel or fabric of the
invention article. In a preferred embodiment the reinforcing
material is temporarily held in place on fabric and the fabric is
coated, dipped into, etc., invention gel and/or thermoplastic to
form a thin film of said gel and/or thermoplastic between the
fabric and reinforcing material such that the reinforcing material
may move independently to some degree.
[0069] The polymeric material which provides the cushioning effect
in all aspects of this invention may be any polymeric material.
Preferred materials other than the invention gel and those
described above are those elastomers described at pgs. 446-640 of
Volume 8 of the Kirk-Othmer Encyclopedia of Chemical Technology,
Wiley, New York, 1979 and those rubbers described in Synthetic
Rubbers: Their Chemistry and Technology, Blackley, D., Applied
Science Publishers, London, 1983 and Rubber Technology, Morton, M.
Ed., Van Nostrand Reinhold Co., New York, 1987, all three
references incorporated herein by reference. Silicones and
urethanes are included. A preferred embodiment of the present
invention sleeve member, when cushioned, includes a cushioning
material of Kraton.RTM.-type rubber material including those
obtained from Shell, CPT, and GLS. These Kraton.RTM. rubbers are
styrene-ethylene/butylene-sty- rene block copolymers or
styrene-ethylene/propylene block copolymers or styrene
isoprene/butadiene block copolymers and are available in triblock
or diblock form. See, e.g. the Kraton.RTM. Technical Bulletin from
Shell Chemical Company, SC:1102-89, June, 1992, incorporated herein
by reference.
[0070] The cushioning polymeric material used in the present
invention cushioned sleeve member is characterized by a certain
durometer range. Durometers for the invention cushioning material
preferably range from 0-20 on the Shore "A" scale, and 1-100, more
preferably 5-35 on the Shore 00 scale. The lower the number the
softer the material, typically due to a higher level of
plasticizer. One preferred durometer range is 3-14 (A scale),
including all values therebetween and all ranges therebetween.
[0071] The invention polymeric cushioning material may be a blend
of, e.g., Kraton.RTM. rubbers and oils such as mineral oil, etc.
including typical stabilizers, etc. which provide an average
durometer of from 0-20, preferably 3-14 (Shore A). These blends
typically comprise a rubber having a lower durometer (0-10 on the
Shore "A" scale) and a rubber having a higher durometer (e.g.,
11-20). The blends are preferably capable of being stretched 100%
or more, preferably 400% or more before tearing and are capable of
providing a form fit to the residuum due to their inherent
elasticity. In addition, low durometer Kraton.RTM. rubbers and
other materials tend to have a sticky feeling which, when present
in the polymeric cushioning material, tends to enhance the form
fitability of the sleeve essentially by mating against the
skin.
[0072] In donning those articles of the invention which, when worn,
provide contact between, e.g., the invention gel, a thermoplastic
material, a combination thereof, etc., with the skin and/or a
prosthetic device it is preferred that the invention article be
donned in a manner such that the polymeric material does not drag
against the skin. For example, the invention cushion liner or
sleeve can be rolled before donning, and then unrolled on the limb
and/or device. In this manner, the cushioning polymeric material
encloses the limb and/or device without sliding or friction. If the
invention article has an outer textile surface, the textile
material slides against itself, providing easy action. With regard
to the open-ended sleeve described herein a particular advantage is
obtained when this open-ended sleeve has an interior middle band of
fabric. The distal and proximal portions of the open-ended sleeve
can be rolled towards the middle of the sleeve, and the sleeve can
be donned with contact between the wearer or device and fabric
only. The thermoplastic-containing portions can then be unrolled
onto the wearer and/or device. In all cases, the invention articles
can be taken off by reversing the above-describe processes. This
aspect of the invention (easy donning and doffing) is an important
advance in the art provided by the present invention. No lubricant,
talcum powder, etc. is required, as with currently available
materials. In addition, the invention articles, regardless of their
composition, can be adapted such that the portion thereof which
will come in contact with the user's apparel such as pant legs,
shirt sleeves, etc. is fabric or covered with fabric such that the
wearer's apparel does not stick to and bunch on the invention
articles. At the same time the invention articles can be designed
to have polymeric material (gel, etc.) exposed in strategic
locations to aid suspension and maximize comfort. In the case of
the knee sleeve a band of gel on the inside of each open end not
only helps to hold the sleeve in place but can also provide an
air-tight seal for a suction -suspension-system when worn such that
the lower portion covers a hard socket and the upper portion
contacts the skin, an invention sleeve, etc. In the case of, e.g.,
the invention sleeve member gel, etc. can be placed on the exterior
for contact with a hard socket.
[0073] If desired, the present invention cushioning material may
comprise antioxidants such as Vitamins A, B and C or any other
antioxidants commonly used in polymers which can weep out on a time
release basis. In addition, skin conditioning agents may be added
to the polymeric material of the present invention to soothe the
skin during wear. Such skin conditioners include mineral oil, baby
oil, etc. which may be added to the polymeric material prior to its
application to the sleeve member. Also, astringents, biocides,
medicaments, etc. may be added or applied to the cushioning
material to avoid infection or heal sores, etc.
[0074] As described above, the cushioning material of the present
invention is preferably formed in a recessed achilles fashion on
the interior of the invention articles. Cushioning material may
also be applied to the exterior. In both cases, it is preferred
that the cushioning material be applied such that it provides an
interface between the amputee's stump and a prosthetic device or
provides padding and/or joint support but minimizes or eliminates
contact with the skin at the back of the knee or elbow when worn.
The cushioning material may be separated from the skin by a piece
of fabric, by an interior sock liner, or may contact the skin
directly. Such contact with the skin can reduce sweating, etc.
[0075] While several methods may be used to apply the cushioning
material to fabric, a preferred method includes the dipping of the
closed end of the invention article into molten or liquified
cushioning material at an angle of from 0.degree. to 90.degree.,
preferably 20-50.degree., most preferably 24-45.degree., with
respect to the surface of the molten or liquid cushioning material.
In this manner, the cushioning material extends up the article from
the closed end thereof to a further extent on the side of the
liner, sleeve, etc. to be positioned in front of the knee than
behind the knee (e.g., the pattern in FIG. 1a faces forward on a BK
amputee). As long as the cushioning polymeric material minimizes or
eliminates contact with the skin at the back of the knee or elbow
when worn while coming over these joints, but still provides an
interface between the amputee's stump and a prosthetic device or
provides joint support and/or padding, the material is in a
recessed achilles configuration. Preferably the polymeric material
comes up at least about {fraction (1/2)}-18, preferably {fraction
(1/2)}-10, more preferably 3-8 inches, including all values and
ranges therebetween these several values, from the closed end of
the articles in front of the knee or elbow and covers the knee. The
difference in height of the cushioning material behind (i.e., in
the crease of) the knee or elbow as opposed to in front of the knee
or elbow can differ by several inches measured from the closed end
of the article, typically from 1-15 inches, preferably 1-8 includes
and all values therebetween and all ranges therebetween these
several values. In a preferred embodiment the cushioning material
is thicker at the closed end of the article than it is towards the
open end.
[0076] In addition to the application of the invention gel and/or
polymeric cushioning material to, e.g., the sleeve member by
dipping into liquified or molten polymeric material or painting the
material on the article, etc., it is possible to dissolve the
polymeric material in a solvent followed by application of the
solvent to the article with subsequent evaporation of the solvent.
Close control of the thickness of the polymeric material is
obtained using this method. In both the direct dipping and solvent
methods the article is generally spun with distal end angling
downward to provide tapered thickness while drying. In general, the
thickness of the polymeric material applied to the invention
articles in any fashion including in a recessed achilles fashion
can be any thickness to, e.g., several inches, but preferably
varies from 0.001-0.500 inches, preferably 0.011-0.150 inches but
all values and all ranges therebetween these several values, and
can be substantially nonconstant in thickness throughout. For
example, the cushioning material preferably may be thicker at the
closed end of the sleeve (e.g., 0.125 in thick) and be tapered or
feathered in decreasing thickness as the open end is approached.
Such changes in thickness can be accomplished by techniques known
to those of ordinary skill in this art and are within their skill.
For example, compression molding can be used.
[0077] Another preferred method of producing the invention articles
is injection molding. The article is pulled over a core and
inserted into a cavity with polymeric material being injected into
the cavity.
[0078] A preferred embodiment of the invention is a flat sheet of
fabric coated, and/or impregnated with thermoplastic, preferably
invention gel, and having a strip of fabric on top of the gel. When
the fabric (preferably looped nylon) is rectangular and a
rectangular strip of fabric is used on top of cushioning material,
the resulting flat sheet can be wrapped around the knee or elbow
such that the large fabric piece is on the outside, the small piece
of fabric is on the inside and against the knee or elbow, and the
gel (thermoplastic) cushioning material contacts the leg or arm
above the knee or elbow. The sheet can be held in place with, e.g.,
velcro.RTM..
[0079] Any piece of invention article can be made by direct molding
in the intended shape or by making an invention cushioned flat
sheet or cushioned fabric, cutting it into pattern, and connecting
the patterns into the desired shape by sewing, heat-bonding,
bonding with adhesive, solvent bonding, etc. Such flat sheet
material can be used to make articles to fit any part of the body
to provide cusioning, support, protection from environmental
elements, the timed release of conditioners, biocides, etc.
[0080] "Covering for enclosing an amputation stump" is a generic
term for all articles described herein whether made of gel, fabric,
thermoplastic, or combination. This term is descriptive and does
not limit the uses of invention articles.
[0081] In another embodiment of the application the invention gel
and gel/fabric laminates described above can be used to form any
article that contacts the body such as a shoe orthosis, knee pad,
glove, shirt, hip wader, etc.
[0082] Other features of the invention will become apparent in the
course of the following descriptions of exemplary embodiments which
are given for illustration of the invention only and are not
intended to be limiting thereof.
EXAMPLES
Example 1
[0083] A form-fit next-to-skin sock was prepared from an 88%
supplex nylon/12% lycra spandex jersey knit fabric using woolly
nylon thread and a surged flat-locked stitch. The sock comprises
two pieces of fabric, the first piece having the pattern described
in FIG. 1a, the second piece having the pattern described in FIG.
1b.
[0084] A mixture of melted Kraton.RTM. rubbers obtained from Shell
(G1652) and GLS (6705) and Duoprime.RTM. 70 oil (mineral oil) was
prepared, the sewn inverted sock was then placed over a mold
facsimile of an amputation stump having recessed portions at what
would be either side of the tibia and dipped into the molten
Kraton.RTM. blend at an angle of 24.degree.-28.degree. with regard
to the plane of the surface of the molten Kraton.RTM. and removed.
The mold was spun during drying. A form-fit cushioned stump sock
was obtained having adhered cushioning material in a recessed
achilles arrangement on the interior thereof.
Example 2
[0085] A {fraction (1/16)} inch thick neoprene textile fabric with
nylon tricot surface treatment for above the knee contact was used
to prepare a three-piece form fitting sleeve member according to
the present invention using the pattern described in FIG. 3. The
{fraction (1/16)} inch neoprene material for the below the knee
segment of the invention sleeve had nylon on the exterior side and
looped nylon on the interior side. The against the skin side of the
above knee segment of the invention sleeve was neoprene which
provided a high friction bond. This form fitting sock was dipped
into molten Kraton.RTM. (a blend of tough and soft Kraton.RTM. used
in Example 1) at an angle of 24.degree.-28.degree. to provide a
cushion material on the interior thereof. The resultant composite
sock of nylon, neoprene, looped nylon and cushioning rubber
provides a durable cushioned sleeve member which, when impregnated
with rubber, has an approximate thickness of {fraction (1/8)}
inch.
Example 3
[0086] A polartec 2000 stretch laminate fabric having an 85%
nylon/15% Lycra.RTM. spandex face and a 94% polyester/6% Lycra.RTM.
spandex back was used to prepare an invention sleeve member using
the pattern described in FIG. 1. The resultant sleeve member is a
form-fitting tubular member for enclosing an amputation stump.
Example 4
[0087] A commercial cotton tube sock is inverted and dipped into
molten elastomer at an angle of 26.degree. relative to the plane of
the molten elastomer. A sock having cushioning material in a
recessed achilles configuration is obtained.
Example 5
[0088] A 2-piece form fitting sleeve was made from a fabric
containing 57% polyester, 33% nylon, and 10% lycra and was placed
over a core pattern. A mixture of molten C-Flex 1970-W5 (67 wt %)
and Duoprime 70 mineral oil (33 wt %) was poured into a cavity and
the core with sleeve was placed in the cavity to produce a cushion
liner.
Example 6
[0089] A 2-piece form fitting sleeve was made of a nylon/Lycra
materia. An adapter was injection molded into the closed end of the
sleeve with polypropylene. The sleeve with adapter was then
inverted and placed over a core. A mixture of molten C-Flex 1970-W5
(50 wt %) and Duoprime 70 mineral oil (50 wt %) was poured into a
cavity and the core with sleeve was placed in the cavity to produce
a cushion locking liner. After molding, a pin was threaded into the
adapter which was adapted to mate with a lock built into a
prosthetic socket.
Example 7
[0090] One end of a tubular knitted terry stockinette was sewn
closed and the open end was slid over a core pattern. A mixture of
molten C-Flex 1970-WS (57 wt %) and Duoprime 70 mineral oil (43 wt
% was poured into a cavity and the core with stockinette was placed
in the cavity. Once the gel had cooled, the stockinette with gel
was removed and the closed end cut off to produce a cushion knee
sleeve.
Example 8
[0091] A 2-piece form fitting sleeve was made from a fabric
containing 83% poly and 17% Lycra. A mixture of molten C-Flex
1970-W5 (62.5 wt %) and Carnation mineral oil (37.5 wt %) was
poured into a cavity and the core with sleeve was placed in the
cavity to produce a cushion liner. A metal threaded insert was
molded to the distal end of the cushion liner with urethane to
produce a locking liner.
Example 9
[0092] Two 2-piece form fitting sleeves were made from a stretch
fabric. One form fitting sleeve was placed in a cavity with the
open end fixed to the top of the cavity. The other form fitting
sleeve was placed over the core. A molten elastomer was poured into
the sleeve in the cavity and the core with the other sleeve was
placed in the cavity to produce a cushion liner with fabric on both
the inside and outside and gel between the fabric.
Example 10
[0093] A 2-piece form fitting sleeve was made from a stretch fabric
and placed over a core. A knitted nylon dome was placed over the
closed end of the sleeve. Molten elastomer was poured into a cavity
and the core with sleeve and knitted dome was placed in the cavity
to produce a cushion liner with reinforcement.
Example 11
[0094] A rectangular shaped piece of looped nylon is placed in the
cavity of a rectangular mold. Molten gel is poured over the looped
nylon and a rectangular strip of fabric is placed across the middle
third of the rectangular mold. The resulting flat sheet can be
wrapped around a knee so that the large piece of fabric is on the
outside, the small piece of fabric is against the knee, and gel
contacts the leg above and below the knee. The flat sheet can be
held in place on the leg with the hook portion of Velcro.
[0095] This application includes the subject matter of U.S. Ser.
No. 08/406,145 incorporated herein by reference. The material
safety data sheets and product brochures of the
commercially-available materials mentioned herein are also
incorporated herein by reference.
[0096] The invention articles are designed primarily for the human
wearer, and thus are sized appropriately. Diameters typically vary
from 1-8 inches (unstretched) and overall lengths typically vary
from 1-30 inches (unstretched). Obviously, numerous modifications
are available which fall within the scope of the invention and
appended claims.
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