Note: Descriptions are shown in the official language in which they were submitted.
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FLEXIBLE INNER SOCKET FOR PROVIDING INNER CIRCUMFERENCE
REDUCTION TO RIGID PROSTHETIC SOCKET
BACKGROUND OF 'THE INVENTION
Field of the Disclosure
[0001] The present disclosure generally relates to a flexible inner socket
that can be
placed within a prosthetic socket, method of using and making the same and
more particularly to
flexible inner socket for providing at least a partial inner circumference
reduction of the
prosthetic socket.
Description of the Related Arts
[0002] Global interior circumference reduction (also referred to as "global
reduction") of
rigid prosthetic sockets is required to provide a tight fit to the residual
limb so as to bear weight
on the compressed soft tissue thereby reducing loads to the amputated bone
ends. The related art
process of applying global reduction to rigid prosthetic sockets is an artful
manual process.
[0003] Conventionally, a practitioner manually forms a rigid prosthetic socket
over a
plaster model of a user's residual limb. The practitioner first manually forms
the plaster model
from a cast of the user's residual limb. After the plaster model is formed,
the practitioner
reduces the circumference of the plaster model by hand crafting, e.g., hand
scraping and hand
sanding. As the rigid prosthetic socket is formed over the globally reduced
plaster model, the
reduction in the circumference of the plaster model causes the global
reduction of the rigid
prosthetic socket.
[0004] Sometimes, a flexible inner socket is placed inside the rigid
prosthetic sockets for
cushioning, comfort, and adjustability. In the conventional process, the
practitioner manually
forms the flexible inner socket over the globally reduced plaster model, and
then forms the rigid
prosthetic socket over the flexible inner socket. However, the conventional
process of making
flexible inner sockets is time consuming, produces a large amount of waste,
and has a high
failure rate. Practitioners have to manually make flexible inner sockets one
by one by hand
draping hot thermoformable sheet plastic over plaster models. And they often
have to repeat the
process multiple times to get a satisfactory flexible inner socket. Because
the plaster model, the
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flexible inner socket, and the rigid prosthetic socket are all made manually
by the practitioner,
the conventional process of applying the global reduction to the rigid
prosthetic socket requires a
high degree of practice and experience. Due to the challenge of this artful
manual process, lack
of practice and experience of practitioners, and intra- and inter-practitioner
variability,
conventionally applied global reduction is often inaccurate, which can cause
discomfort to the
user regardless of the use of the flexible inner socket. Thus, improved
techniques for applying
global reduction to rigid prosthetic sockets and for forming flexible inner
sockets are needed.
SUMMARY OF THE INVENTION
100051 Accordingly, the invention is directed towards a flexible inner socket
for
providing inner circumference reduction to prosthetic socket.
[0006] An advantage of the invention is to provide a process that is
reproducible and
faster than related art processes.
[0007] Another advantage of the invention is to provide accurate and precise
global
reduction of the fit of a prosthetic socket that is based on the thickness of
the flexible inner
socket instead of the common laborious practice in the art of hand scraping,
grinding and sanding
and the like.
[0008] Yet another advantage of the invention is to provide flexible inner
sockets in
varied thicknesses that can precisely reduce the global reduction of the fit
as the user's limb
changes size during the day.
[0009] Additional features and advantages of the invention will be set forth
in the
description which follows, and in part will be apparent from the description,
or may be learned
by practice of the invention. The objectives and other advantages of the
invention will be
realized and attained by the structure particularly pointed out in the written
description and
claims hereof as well as the appended drawings.
100101 To achieve these and other advantages and in accordance with the
purpose of the
present invention, as embodied and broadly described, relate to a flexible
inner socket design and
process of fabricating a flexible inner socket. The flexible inner socket is
formed on an inner
surface of a prosthetic socket that has previously been formed to fit a
residual limb of a user.
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The prosthetic socket was formed either directly over the residual limb of the
user or over a
model of the residual limb that has a shape matching the anatomical shape of
at least a portion of
the residual limb. Accordingly, the inner surface of the prosthetic socket has
a contour and
dimensions that match the anatomical shape of at least a portion of the
residual limb. Zero or
insufficient global reduction has been applied to the rigid prosthetic socket,
or the residual limb
has shrunk to the extent that the original global reduction is no longer
effective. The flexible
inner socket, when attached to the inner surface of the rigid prosthetic
socket, adds additional
thickness to the prosthetic socket so that the resulting device (i.e., the
prosthetic socket plus the
flexible inner socket) has a reduced inner circumference. This is referred to
as global interior
circumference reduction or global reduction of the prosthetic socket. The
global reduction can
be precisely controlled based on the thickness of the flexible inner socket.
[0011] In another aspect of the invention, an embodiment is directed towards a
flexible
inner socket is made using a preformed socket (also referred to as "pre-
socket"). The pre-socket
is formed from a material, e.g., polymer, thermoplastic material, and the
like, using techniques
such as injection molding, rotational molding, three-dimensional (3D)
printing, blow molding,
combinations of the same and the like. The pre-socket has an opening (e.g.,
the opening through
which the residual limb will ultimately be inserted) and an enclosed end
(e.g., where the residual
limb ultimately rests). The enclosed end is opposite the opening. The pre-
socket has an outer
circumference that is smaller than the inner circumference of the rigid
prosthetic socket. The
pre-socket is heated and then molded onto the inner surface of the rigid
prosthetic socket to form
the flexible inner socket. In another aspect of the invention, an embodiment
is directed towards a
method of forming a flexible inner socket including providing a rigid
prosthetic socket
configured to fit at least a portion of a residual limb of a user. The rigid
prosthetic socket
comprises a first end, a second end, an inner circumference, the first end
having an opening, the
second end being substantially closed, and an inner surface having contours
that substantially
mimic contours of the residual limb. The rigid prosthetic socket has not been
globally reduced in
dimension. The method also includes providing a flexible pre-socket comprising
a
thermoformable material. The flexible pre-socket includes a first end, a
second end, a thickness,
an inner circumference, and an outer circumference, the first end having an
opening, and the
second end being substantially closed. The method further includes heating the
thermoformable
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material of the flexible pre-socket to a temperature so that the flexible pre-
socket becomes a
formable flexible pre-socket and arranging at least a portion of the formable
flexible pre-socket
into the rigid prosthetic socket. Next the heated pre-socket is molded onto
the inner surface of
the rigid prosthetic socket such that the outer circumference of the formable
flexible pre-socket
substantially follows the contours of the inner surface of the rigid
prosthetic socket, thereby
reducing the inner circumference of the rigid prosthetic socket in a
predetermined manner based
on the thickness of the flexible pre-socket to provide a globally reduced fit
of the rigid prosthetic
socket.
100121 Yet another aspect of invention an embodiment is directed towards a
method of
forming a flexible inner socket including providing a rigid prosthetic socket
configured to fit at
least a portion of a residual limb of a user. The rigid prosthetic socket
includes a first end, a
second end, an inner circumference, the first end having an opening, the
second end being
substantially closed, and an inner surface having contours that substantially
mimic contours of
the residual limb, and the rigid prosthetic socket has not been globally
reduced in dimension.
The method also includes providing a flexible pre-socket and heating the
flexible pre-socket to a
temperature so that the flexible pre-socket becomes a moldable. The heated pre-
socket is then
arranged into the rigid prosthetic socket. Next, heated pre-socket is molded
onto the inner
surface of the rigid prosthetic socket such that the outer circumference of
the formable flexible
pre-socket substantially follows the contours of the inner surface of the
rigid prosthetic socket.
100131 In still another aspect of the invention, an embodiment is directed
towards a
method of forming a flexible inner socket. The method includes providing a
prosthetic socket
having an inner surface with contours that substantially mimic contours of the
residual limb and
providing a pre-socket. The pre-socket is heated with a heat source to a
temperature where the
pre-socket becomes a moldable and at least a portion of the pre-socket is
arranged into the
prosthetic socket. Next, the heated pre-socket is molded onto the inner
surface of the rigid
prosthetic socket such that an outer circumference of the pre-socket
substantially follows one or
more of the contours of the inner surface of the rigid prosthetic socket.
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[0014] Yet still another aspect of the invention, an embodiment is directed
towards a
prosthetic system for an end user. The system includes a rigid prosthetic
socket configured to fit
at least a portion of a residual limb of a user. The rigid prosthetic socket
includes a first end, a
second end, an inner circumference, the first end having an opening, the
second end being
closed, and an inner surface having contours that substantially mimic contours
of the residual
limb and the rigid prosthetic socket has not been globally reduced in
dimension. The system
further includes a molded flexible pre-socket comprising a thermoformable
material, wherein the
flexible pre-socket comprises a first end, a second end, a thickness, an inner
circumference, and
an outer circumference, the first end haying an opening, and the second end
being closed. The
molded flexible pre-socket substantially follows the contours of the inner
surface of the rigid
prosthetic socket, thereby reducing the inner circumference of the rigid
prosthetic socket in a
predetermined manner based on the thickness of the flexible pre-socket to
provide a globally
reduced fit of the rigid prosthetic socket.
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100151 Yet still another aspect of the invention, an embodiment is directed
towards a
prosthetic system for an end user. The air inlet assembly for use with a
flexible pre-socket
includes a sealing mechanism, a lid having a first side, a second side, a
valve and a channel
region around a circumference of the lid, the channel region configured to
receive the sealing
mechanism and at least a portion of the flexible pre-socket. The air inlet
assembly further
includes a hose configured to be releasably connected to the valve and the lid
is configured to
cover an opening on the flexible pre-socket and the sealing mechanism is
configured to seal the
lid to the flexible pre-socket. Unlike conventional methods of fabrication
where the flexible
inner socket is formed on a plaster cast of the limb and where the rigid
prosthetic socket is
formed over the flexible inner socket, the flexible inner socket and method of
fabricating
described here include actually forming the flexible inner socket inside the
rigid prosthetic
socket, where the prosthetic socket was previously formed to fit the user's
residual limb, without
global reduction being applied. Also, the flexible inner socket is formed from
a preformed
socket that can be made by using techniques such as injection molding,
rotational molding, 3D
printing, blow molding, combinations of the same and the like, as opposed to
hand crafting in the
conventional methods. Thus, the inner circumference reduction provided by the
flexible inner
socket here can be more accurate and precise. The techniques can be used to
manufacture pre-
sockets of various shapes and sizes to fit rigid prosthetic sockets of various
shapes and sizes.
100161 This Summary section is neither intended to be, nor should be,
construed as being
representative of the full extent and scope of the present disclosure.
Additional benefits, features
and embodiments of the present disclosure are set forth in the attached
figures and in the
description hereinbelow, and as described by the claims. Accordingly, it
should be understood
that this Summary section may not contain all of the aspects and embodiments
claimed herein.
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[0017] Additionally, the disclosure herein is not meant to be limiting or
restrictive in any
manner. Moreover, the present disclosure is intended to provide an
understanding to those of
ordinary skill in the art of one or more representative embodiments supporting
the claims. Thus,
it is important that the claims be regarded as having a scope including
constructions of various
features of the present disclosure insofar as they do not depart from the
scope of the methods and
apparatuses consistent with the present disclosure (including the originally
filed claims).
Moreover, the present disclosure is intended to encompass and include obvious
improvements
and modifications of the present disclosure.
BRIEF DESCRIPTION OF THE DRAWINGS
[0018] The accompanying drawings, which are included to provide a further
understanding of the invention and are incorporated in and constitute a part
of this specification,
illustrate embodiments of the invention and together with the description
serve to explain the
principles of the invention.
In the drawings:
[0019] FIG. lA is a perspective view of a flexible inner socket, in accordance
with an
embodiment of the invention;
[0020] FIG. 1B illustrates the flexible inner socket of FIG. 1A arranged in a
prosthetic
socket of FIG. 1B, in accordance with the embodiment;
[0021] FIG. 1C illustrates a cross-sectional view of a residual limb of a user
at least
partially arranged in the flexible inner socket and the prosthetic socket of
FIGS. 1A-1B, in
accordance with the embodiment;
[0022] FIG. 2A is a perspective view of a preformed socket or pre-socket, in
accordance
with another embodiment;
[0023] FIG. 2B is a cross-sectional view of the preformed socket or pre-socket
along, in
accordance with another embodiment;
[0024] FIG. 2C is a top view of the preformed socket or pre-socket, in
accordance with
another embodiment;
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[0025] FIG. 2D is a bottom view of the preformed socket or pre-socket, in
accordance
with another embodiment;
[0026] FIG. 3 illustrates a group of preformed sockets or pre-sockets having
different
shapes and dimensions, in accordance with another embodiment;
[0027] FIG. 4 illustrates cross-sectional view of two preformed sockets or pre-
sockets,
each of which has a uniform thickness, in accordance with another embodiment;
[0028] FIG. 5 illustrates pre-sockets having non-uniform thicknesses, in
accordance with
another embodiment
[0029] FIG. 6 illustrates an air inlet assembly used for molding a preformed
socket, in
accordance with another embodiment;
100301 FIGS. 7A-7D illustrate a process of molding a preformed socket or pre-
socket
onto an inner surface of a rigid prosthetic socket by using the air inlet
assembly, in accordance
with another embodiment;
[0031] FIG. 8 illustrates wraps used for constraining a preformed socket or
pre-socket
during molding of the pre-socket, in accordance with another embodiment;
[0032] FIG. 9 illustrates a process of molding a preformed socket onto an
inner surface
of a rigid prosthetic socket by using an air bag, in accordance with another
embodiment;
100331 FIG. 10A is a perspective view of a system of molding a preformed
socket onto
an inner surface of a rigid prosthetic socket by vacuum, in accordance with
another embodiment;
[0034] FIG. 10B is a cross-sectional view of the system, in accordance with
another
embodiment;
[0035] FIG. 11 illustrates another system of molding a preformed socket onto
an inner
surface of a rigid prosthetic socket by vacuum, in accordance with another
embodiment;
[0036] FIGS. 12A-12B illustrate a process of trimming a flexible inner socket
1200, in
accordance with another embodiment; and
[0037] FIG. 13 illustrates a flow chart of a process for fabricating a
flexible inner socket,
in accordance with another embodiment.
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DETAILED DESCRIPTION
[0038] In the following description of embodiments, numerous specific details
are set
forth in order to provide more thorough understanding. However, note that the
embodiments
may be practiced without one or more of these specific details. In other
instances, well-known
features have not been described in detail to avoid unnecessarily complicating
the description.
[0039] Embodiments are described herein with reference to the figures where
like
reference numbers indicate identical or functionally similar elements Also, in
the figures, the
left most digits of each reference number correspond to the figure in which
the reference number
is first used.
[0040] One embodiment relates to forming a flexible inner socket including the
steps of
providing a prosthetic socket configured to fit at least a portion of a
residual limb of a user. The
prosthetic socket includes a first end, a second end, an inner circumference,
and an inner surface
having contours that substantially match contours of the residual limb,
wherein the prosthetic
socket has not been globally reduced in dimension, was insufficiently globally
reduced, or
changes in the patient's residual limb have resulted in the global reduction
to be insufficient.
The process also includes forming a pre-socket by using a thermoformable
material, the pre-
socket comprising a first end, a second end, a thickness, an inner
circumference, and an outer
circumference, the first end having an opening, and the second end being
closed. The process
further includes heating the thermoformable material of the pre-socket to a
temperature so that
the pre-socket becomes a formable pre-socket arranging the formable pre-socket
into the
prosthetic socket. The process also includes molding the formable pre-socket
onto the inner
surface of the prosthetic socket such that the outer circumference of the
formable pre-socket
substantially follows the contours of the inner surface of the prosthetic
socket, thereby reducing
the inner circumference of the prosthetic socket in a predetermined manner
based on the
thickness of the pre-socket to provide a globally reduced fit of the
prosthetic socket.
[0041] The term pre-socket and socket are used interchangeably herein.
[0042] Formable pre-socket or socket means a thermoplastic or thermoformable
material
that when heated, becomes pliable and stretchable so as to assume a new shape
when formed and
thereby holding that shape when cooled. In one embodiment, the heating
temperature is
between about 170 F to about 300 F and the temperature when cooled is about
125 F or below.
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In a preferred embodiment, the heating temperature is 225 F to about 280 F
(and when cooled
about 150 F or below).
[0043] In one embodiment, the pre-socket may have an open end and a
substantially
closed end. The substantially closed end may have a channel that extends from
an inside portion
to an outside portion through a thickness of the pre-socket.
[0044] In one embodiment, the preformed socket is heated, e.g., to a
temperature in a
range from about 190 F to about 285 F or greater to become pliable, and
molded onto the inner
surface of the rigid prosthetic socket In a preferred embodiment, the
preformed socket is placed
heated, e.g., to a temperature in a range from about 170 F. and 280 F. The
pre-socket can be
heated with a heat source, e.g., an infrared heater, convection oven, silicone
pad heater, halogen
tube heater or other common heating devices.
[0045] Globally reduced means a reduction in the inner circumference of a
lower leg
prosthetic socket that is applied over the majority of the interior so that a
user's residual limb
soft-tissue is compressed in a conical fashion when worn so as to properly
bear weight away
from the amputated bone end. Global reduction is typically applied by hand
filing, scraping and
sanding of the plaster model which is an imprecise method. Global reduction is
a common
industry term well known and the typical reduction is about 4%.
[0046] In one embodiment, the thickness of the pre-socket is determined based
on the
inner circumference of the prosthetic socket so as to achieve a desired global
reduction according
to Formula 1:
T=C42-20-X/100 (Formula 1)
[0047] The units and variables are as follows: T is thickness of the pre-
socket [mm], C is
inner circumference of the rigid prosthetic socket that has not been globally
reduced in
dimension [mm], and X is global reduction %.
[0048] In one embodiment, the pre-socket of the flexible inner socket becomes
the final
flexible inner socket after it is molded as described herein.
[0049] In one embodiment, the thickness of the flexible inner socket can be
controlled in
the fabrication process (such as a manufacturing process), e.g., by
controlling the thickness of the
preformed socket from which the flexible inner socket is formed. The preformed
socket may
have a uniform thickness, or different portions of the preformed socket can
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thicknesses. Accordingly, compression of the tissue of the user's residual
limb can be precisely
and selectively controlled to achieve proper distribution of the weight of the
user and
comfortable fit of the prosthetic socket. Compared with conventional processes
of fabricating
flexible inner sockets one by one by hand, this two-step process is more
repeatable and less
dependent on intra- and inter-practitioner variability in hand-shaping plaster
models and rigid
prosthetic sockets. It also requires less skill, guesswork, material waste,
and time. Also, this
two-step process allows for mass manufacturing of the flexible inner socket.
[0050] In one embodiment, the pre-socket or socket can be formed with blow
molding,
injection material or other techniques. In one embodiment, the pre-socket or
socket is formed
from a thermoformable material. The thermoformable material includes one or
more of a
thermoplastic elastomer material, a thermoplastic polyurethane (TPU) material,
a thermoplastic
polyurethane foam material, a thermoplastic vulcanizate (TPV) material, a
rubber material, an
ultra-low density polyethylene (ULDPE) material, an ethylene vinyl acetate
(EVA) material, a
styrene material and blends of the same
[0051] In one embodiment, the thermoformable material can include a closed
cell foam
material, a non-compressible material, or a compressible material.
100521 In one embodiment, the thermoformable material has one or more of the
following physical properties: an A-type durometer in a range from about 55 to
about 95, an
elongation in a range from about 200 % to about 600 %, and a forming point
temperature in a
range from about of below about 170 F to about 300 T.
[0053] In one embodiment, the pre-socket is formed with an opening and with an
enclosed end that is opposite to the opening. The pre-socket has a
circumference determined
based on an inner circumference of a prosthetic socket, e.g., the
circumference of the pre-socket
can be smaller than the inner circumference of the prosthetic socket, e.g.,
smaller by up to 15%,
so that the pre-socket can be arranged on inside the prosthetic socket. The
prosthetic socket has
previously been formed to fit a residual limb of a user with techniques
described herein or
conventional techniques. No global reduction has been applied or needed to the
prosthetic
socket, thereby saving tremendous process time in the overall process.
[0054] In one embodiment, the flexible inner socket is formed after a
preformed socket is
arranged inside the prosthetic socket. The preformed socket is heated, so that
is pliable and
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pressed onto the inner surface of the prosthetic socket such that the outer
circumference of the
heated preformed socket substantially follows the contours of the inner
surface of the prosthetic
socket, thereby reducing the inner circumference of the prosthetic socket in a
predetermined
manner based on the thickness of the pre-socket to provide a globally reduced
fit of the
prosthetic socket. The preformed socket can be pressed into the prosthetic
socket with an
assistance of a pressured device, e.g., an airbag can be utilized to press
against the inner surface
of the heated preformed socket so that it molds against the inner surface of
the prosthetic device.
[0055] In one embodiment, a method of forming a flexible inner socket, by
providing a
prosthetic socket configured to fit at least a portion of a residual limb of a
user, the prosthetic
socket comprises a first end, a second end, an inner circumference, the first
end having an
opening, the second end being closed, and an inner surface having contours
that substantially
mimic contours of the residual limb, wherein the prosthetic socket has not
been globally reduced
in dimension. Next, providing a pre-socket including a thermoformable
material, the pre-socket
including a first end, a second end, a thickness, an inner circumference, and
an outer
circumference, the first end having an opening, and the second end being
closed. The method
further includes heating the thermoformable material of the pre-socket to a
temperature so that
the pre-socket becomes a formable pre-socket and arranging at least a portion
of the formable
pre-socket into the prosthetic socket. The method also includes molding the
formable pre-socket
onto the inner surface of the prosthetic socket such that the outer
circumference of the formable
pre-socket substantially follows the contours of the inner surface of the
prosthetic socket, thereby
reducing the inner circumference of the prosthetic socket in a predetermined
manner based on
the thickness of the pre-socket to provide a globally reduced fit of the
prosthetic socket.
[0056] Optionally and/or alternatively, the method further includes to assist
with the
molding providing an air inlet assembly including a lid, a sealing mechanism,
a valve in
communication with the lid and a hose in communication with the valve. The lid
is configured
to cover the opening on the formable pre-socket. The sealing mechanism is used
to seal the lid
to formable pre-socket and the entire assembly is arranged into at least a
portion a prosthetic
socket. The formable pre-socket is inflated with the air inlet assembly to a
pressure configured
to conformally arrange at least a portion of an outer surface of the formable
pre-socket against an
inner surface of the prosthetic socket.
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[0057] In one embodiment, the flexible inner socket can be attached to the
inner surface
of the rigid prosthetic socket such that it holds the residual limb when a
user wears the prosthetic
socket. The flexible inner socket can be designed to be removable or non-
removable from the
prosthetic socket.
[0058] In one embodiment, the thickness of the flexible inner socket is
predetermined
and configured to provide a globally reduced fit of the prosthetic socket. In
one embodiment, the
inner circumference reduction of the prosthetic socket allows tissue of the
residual limb of the
user to be compressed against the material of the flexible inner socket The
compressing of the
tissue in this manner more evenly distributes the weight born by the residual
limb over the entire
residual limb. The compressed tissue bears more weight over a larger surface
area instead of
bearing much of the weight at various points on the tissue that correspond to
the bone ends and
prominences of the residual limb. This allows the prosthetic socket to have a
tight and
comfortable fit.
[0059] In one embodiment, a rigid prosthetic socket is sized and fitted to the
users
residual limb by various conventional techniques including making a plaster
cast and filling the
cast with plaster to make a model which the socket is subsequently made from.
Optionally, a
heat formable material can be direct formed to the plaster model or directly
to the users residual
limb. The prosthetic socket would require a global reduction, e.g., about 4%,
so that it fits tightly
to the residual limb to properly fit and bear weight. In this embodiment,
aspects of the invention
and methods are configured to omit the global reduction step which is time
consuming, requires
considerable experience and technique, and often results in an imprecise shape
and fit. In this
case the socket is fitted precisely to the residual limb without any global
reduction.
[0060] After the rigid prosthetic socket, which has not been reduced, was
insufficiently
globally reduced, or, as a result of residual limb volume reduction, provides
insufficient global
reduction the method of using and making a flexible inner socket is
applicable. In this method, a
global reduction is achieved by heat forming a pre-socket precisely to an
inside of the rigid
socket. The pre-socket is made from a material with properties described
herein. In one
embodiment, the pre-socket becomes softened and formable at about 250 F.
[0061] In one embodiment, the pre-socket is premade by injection molding or
blow
molding in economical repeatable quantities to a shape that fits inside the
rigid prosthetic socket.
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The premade pre-sockets can be made in different sizes so that the proper size
is selected that fits
closely inside the rigid prosthetic socket yet is taller so it extends out the
proximal end. Also,
they can be made in varied thicknesses as well so that the desired amount of
global reduction is
achieved. In one embodiment, the thickness of the pre-socket is about 2 mm
thick and can fits a
person with a medium size residual limb, measuring about 32 cm to about 34 cm
at the distal
end. The thickness after molding as described herein is configured to result
in a global
reduction, e.g., about 4%. Of course, other thickness can be utilized, e.g.,
according to Formula
1. The pre-socket is molded into a flexible inner socket as described herein.
Next it can be
marked for trimming so that it extends about 2 cm above the edge of the rigid
prosthetic socket.
It is removed, trimmed with scissors and the edge is buffed round and smooth
with a rotating
buffing tool.
[0062] Optionally and/or alternatively, after the flexible inner socket is
fitted or molded
back inside the rigid prosthetic socket, the extending edge can be heated,
e.g., about 250 F with
a heat source, e.g., a heat gun, and it can be shaped, e.g., flared by gloved
hands to precisely fit
the needs of the residual limb. Depending on the suspension system desired to
retain the socket
onto the limb, a small hole can be cut in the distal end to allow for suction
or vacuum air to pass
through. Or, a larger hold can be cut to allow for a pin lock system to pass
through.
[0063] The system or combined socket, e.g., rigid prosthetic socket and
flexible inner
socket, can be tested for fit by the user. If the fit needs adjustment, heat
can be applied with a
heat source to the flexible inner socket to reshape it. In a preferred
embodiment, the rigid
prosthetic socket is also heat formable and adjusted as described with
referent to with reference
to U.S. Patent Nos. 15/914,480 and 16/516,199, both of which are hereby
incorporated by
reference as if fully set forth herein. In such a case, both the flexible
inner socket and rigid
prosthetic can heated and adjusted in shape for a truly customizable fit that
can be done at any
time. The result is a precisely globally reduced socket that fits to compress
the limb properly to
bear weight and stay in place which is far superior to the typical hand
reduction done to the
plaster limb model by the practitioner.
[0064] A typical problem for amputees is that their limb can shrink or grow in
circumference at different times through the day, week, month, and/or year.
This typically occurs
as the day passes and use reduces fluid in the limb but it can happen at any
time. Additional
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flexible inner sockets can be made in varied thickness that the user can
insert into the rigid
prosthetic socket to increase or reduce global reduction at any time of the
users. They can replace
the original flexible inner socket or be layered up to change the fit. These
additional flexible
inner sockets can be made in the same fashion described herein.
[0065] Optionally and/or alternatively, an embodiment is directed towards a
method of
forming a flexible inner socket with the use of a cast of the residual limb
filled with plaster to
create a positive model of te limb. The positive model is globally reduced
using traditional
grinding and carving techniques. A pre-socket is formed over the globally
reduced model,
thereby creating a flexible inner socket with an inner surface that matches or
mimics the surface
and contours of the positive model that has been globally reduced. The pre-
socket thickness may
be any thickness described herein. The flexible inner socket may be formed
with hand pressure
or with the aid of vacuum pressure or positive pressure, e.g., with apparatus
and techniques
described herein. A rigid prosthetic socket is then fabricated over the
flexible inner socket so
that the inner surface of the rigid socket matches the surface and contours of
the outer surface of
the flexible inner socket. Use of the pre-socket rather than traditional sheet
materials saves
processing steps, time and reduces material waste, and the end result is a
rigid prosthetic socket
with the flexible inner socket that provides global reduction to the limb.
[0066] Reference will now be made in detail to an embodiment of the present
invention,
example of which is illustrated in the accompanying drawings.
[0067] FIG. lA is a perspective view of a flexible inner socket 100 fabricated
from a pre-
socket in accordance with an embodiment of the invention. FIG. 1B illustrates
the flexible inner
socket of FIG. IA arranged in a prosthetic socket of FIG. 1B, in accordance
with the
embodiment. FIG. 1C illustrates a residual limb of a user at least partially
arranged in the
flexible inner socket and the prosthetic socket of FIGS. 1A-1B, in accordance
with the
embodiment.
[0068] Referring to FIGS. 1A-1C, a flexible inner socket formed as described
herein is
generally depicted with reference to 100 and a prosthetic socket is generally
depicted with
reference to 150. In a preferred embodiment, the prosthetic socket is rigid
having a hardness of
greater quantified as an A-type durometer in a range from about 100 or
greater.
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100691 The flexible inner socket 100 has a first end 102, a second end 104,
and the first
end 102 has an opening 110 configured and dimensioned to receive at least a
portion of a
residual limb 190 of a user. The second end 104 is closed end 120 in a rounded
type orientation.
Optionally and/or alternatively, the second end has a hole or channel that
extends through the
thickness 130 of the flexible inner socket 100. A cavity or partial channel is
formed extending
from the open first end 102 to the closed second end 104. The cavity or
channel is configured to
enclose at least a portion of the residual limb 190. The volume of the cavity
is greater than the
volume of the residual limb. The flexible inner socket has a thickness 130. In
a preferred
embodiment the thickness is in a range from about 1 mm to about 8 mm. The
thickness may be
constant or variable about the x-axis or y-axis of the flexible inner socket.
In one embodiment,
the prosthetic socket 150 can be formed and is described with reference to
U.S. Patent Nos.
15/914,480 and 16/516,199, both of which are hereby incorporated by reference
as if fully set
forth herein. In yet another embodiment, the prosthetic socket is can be any
conventional
prosthetic socket as known it the related art.
[0070] The prosthetic socket 150 has a first end 108, a second end 106, and
the first end
108 has an opening 180 configured and dimensioned to receive at least a
portion of a residual
limb 190 of a user and the flexible inner socket 100. The second end 106 is
closed end 170. A
cavity or partial channel is formed extending from the open first end 108 to
the closed second
end 106. The cavity or channel is configured to enclose at least a portion of
the residual limb
190. The volume of the cavity is greater than the volume of the residual limb.
[0071] In one embodiment, a user can position the flexible inner socket 100 on
at least a
portion of the residual limb 190. Next, the user can position at least a
portion of their residual
into the prosthetic socket 150 by inserting the limb through the opening 180
of the first end.
Moreover, the user can position their limb with the flexible inner socket 100
to the second end
106 until the base of the residual limb 190 rests on an inner surface of the
enclosed end 106.
[0072] Referring to FIG. 1C, the residual limb 190 is shown arranged in the
prosthetic
socket 150. For example, a lower calf portion of a residual limb is inside the
prosthetic socket
150 and inside the flexible inner socket 100. The prosthetic socket 150
attaches to a prosthetic
mechanical lower leg to allow a person with a below or above the knee
amputation to walk using
the socket plus prosthesis (not shown).
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[0073] The prosthetic socket 150 includes a cup portion 160 and a base portion
170. The
cup 160 is configured in a shape of a hollow deep or elongated cup that is
generally substantially
cylindrical in shape and has an outer surface and an inner surface. The inner
surface of the cup
160 is the inner surface of the prosthetic socket 150. The circumference of
the inner surface is
the inner circumference of the rigid prosthetic socket 150. The cup 160 is
formed with an
opening 180 via which the residual limb 190 can be inserted into the cup 160.
[0074] In this embodiment, the cup 160 is shapeable after being heated at a
shaping
temperature. The shaping temperature can be in the range of about 150 F to
about 302 F and
any sub-range within. The shaping time can be in the range of about five
minutes to about
fifteen minutes, or any sub-range within. In one embodiment, the cup 160 has a
pliability above
a threshold pliability for a shaping time after being heated at the shaping
temperature. The
shaping time can be in the range of five minutes to fifteen minutes, or any
sub-range within.
During the shaping time, the cup 160 can be stretched circumferentially over
the residual limb or
a plaster model of the residual limb so that the cup 160 is shaped to fit the
residual limb. No
global reduction is applied to the cup 160 during the shaping. In one
embodiment, the cup or
prosthesis and its shaping is described with reference to U.S. Patent No.:
15/914,480 and
16/516,199 each of which is incorporated by reference as if fully set forth
herein.
[0075] The base 170 joins the cup 160 to the prosthesis or is integral with
the base unit.
In one embodiment, the prosthesis can be a conventional prosthesis as known in
the art or the
prosthesis described in U.S. Patent No.: 15/914,480 and 16/516,199 each of
which is
incorporated by reference as if fully set forth herein. The base can have a
pliability that is lower
than the pliability of the cup 160 at the shaping temperature and/or at room
temperature.
Optionally and/or alternatively, the base 170 and the cup 160 are constructed
from the same
material. The base 170 is not heated or is heated at a lower temperature than
the shaping
temperature when the cup 160 is heated. Optionally and/or alternatively, the
base 170 is made
from a different material than the cup 160.
[0076] The prosthetic socket 150 is configured to have an inner dimension to
fit at least a
portion of the residual limb 190. For example, the prosthetic socket 150 may
have been formed
directly over the residual limb 190 or over a model of the residual limb 190
without global
reduction being applied. The inner surface of the rigid prosthetic socket 150
can have a contour
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and dimension that match, e.g., the same as or substantially similar to, the
anatomical shape and
dimension of the residual limb 190.
[0077] In one embodiment, after the prosthetic socket 150 has been formed, it
can used to
fabricate the flexible inner socket 100. For example, a preformed socket
having a generic shape
can be heated and molded onto the inner surface of the rigid prosthetic socket
150 to form the
flexible inner socket 100. The heating temperature can be in a range from
about 190 'FL to about
285 F. The flexible inner socket 100 is formed on the inner surface of the
prosthetic socket 150.
The flexible inner socket 100, after heated and formed, therefore can have a
shape matching the
contour of the inner surface of the rigid prosthetic socket 150 and the
anatomical shape of the
residual limb 190.
[0078] In one embodiment, the flexible inner socket 100 can be attached or
releasably
configured on an inner surface of the prosthetic socket 150 to provide an
overall inner
circumference reduction of the prosthetic socket 150 based on the thickness
130 of the flexible
inner socket 100. With the inner circumference reduction, the tissue of the
residual limb 190 is
compressed generally across the surface of the limb, and thereby bears the
weight of the user.
As the tissue has a larger surface area than the bone end and prominences of
the residual limb
190 that might otherwise bear the weight against the hard surface of a rigid
prosthetic socket, the
inner circumference reduction via the compressible material of the flexible
inner socket spreads
the weight and causes a more comfortable fit of the prosthetic socket 150.
Moreover, as
described herein, the reduction reduces the inner circumference of the
prosthetic socket in a
predetermined manner based on the thickness of the pre-socket to provide a
globally reduced fit
of the prosthetic socket.
[0079] In one embodiment, the flexible inner socket 100 is fabricated on the
inner surface
the prosthetic socket 150, the inner circumference reduction can be precisely
controlled. In some
embodiments, the inner circumference reduction is controlled by controlling
the thickness 130 of
the flexible inner socket 100 (or the thickness of the preformed socket that
is used to form the
flexible inner socket 100). The thickness 130 of the flexible inner socket 100
can range from
about 0.5 millimeters (mm) to about 8 mm or greater, or any sub-range within.
The thickness
130 can be determined to provide an inner circumference reduction for
tightening the fit on the
residual limb ranging from about 3 % to about 8 % or sub-ranges within.
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[0080] In some embodiments, the thickness 130 is the same for different
portions of the
flexible inner socket 100 so that the flexible inner socket 100 can provide a
uniform inner
circumference reduction. In other embodiments, the thickness 130 is different
at different
locations of the flexible inner socket 100, and the inner circumference
reduction for different
portions of the rigid prosthetic socket is thereby different, e.g., the
thickness can be a variable
thickness or any combination of thickness. The thickness 130 can be determined
based on
characteristics of the prosthetic socket 150 (e.g., dimensions, shapes, etc.),
characteristics of the
residual limb 190, characteristics of the user (e.g, weight, BMI, shape and/or
dimensions of the
residual limb of the patient, water retention, medical conditions, etc.),
combinations of any of the
same and the like. Additional features and embodiments surrounding the
thickness 130 of the
flexible inner socket 100 is described herein and with reference to FIGS. 4
and 5.
[0081] In one embodiment, after the flexible inner socket 100 is formed, the
opening 110
of the flexible inner socket 100 is trimmed to match the contour of the
opening 180 or
substantially match the contour of the opening 180 of the prosthetic socket
150. The opening
110 and the material of the flexible inner socket 100 can also be configured
to extend above the
opening 180 in a similar contour of the opening 180 of the prosthetic socket
150 as shown in
FIG. 1B. Optionally and/or alternatively, the material of the flexible inner
socket 100 extending
above the prosthetic socket 150 can be folded over the opening 180 of the
rigid prosthetic socket
150.
[0082] In one embodiment, the flexible inner socket 100 is less rigid than the
prosthetic
socket 150 so that it can provide a softer edge to the prosthetic socket 150
for absorption of one
or more of impact, force, stress and to provide comfort to the user. For
example, the flexible
inner socket 100 can have a rigidity expressed with an A-type durometer value
in a range from
about 55 to about 95.
[0083] FIG. 2A is a perspective view of a preformed socket or inner socket, in
accordance with another embodiment. FIG. 2B is a cross-sectional view of the
preformed
socket, in accordance with another embodiment. FIG. 2C is a top view of the
preformed socket,
in accordance with another embodiment. FIG. 2D is a bottom view of the
preformed socket, in
accordance with another embodiment.
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[0084] Referring to FIGS. 2A-2D, a perspective view of a preformed socket 200,
which
can be used to form a flexible inner socket, such as the flexible inner socket
100, by being
molded onto the inner surface of a prosthetic socket 150. The preformed socket
200 can be
formed by using a thermoformable material described herein. The thermoformable
material can
have one or more of the following physical properties: an A-type durometer in
a range from
about 55 to about 95, an elongation in a range from about 200 % to about 600
%, and a forming
point temperature in a range from about of below about 170 F to about 300 F.
Some suitable
examples of a thermoformable material include one or more of a thermoplastic
elastomer
material, a thermoplastic polyurethane (TPU) material, a thermoplastic
polyurethane foam
material, a thermoplastic vulcanizate (TPV) material, a rubber material, an
ultra-low density
polyethylene (LTLDPE) material, an ethylene vinyl acetate (EVA) material, a
styrene material
and blends of the same.
[0085] In one embodiment, the preformed socket 200 can be formed by using
various
techniques, such as injection molding, blow molding, rotational molding, 3D
printing techniques
(e.g., fused deposition modeling, selective laser sintering, and
stereolithography), combinations
of the same and the like. In some embodiments, the preformed socket 200 can
include one or
more layers, and each layer can be made from the same or different
thermoformable material or
thermoformable materials or entirely different materials, e.g., other types of
thermoplastics.
[0086] The preformed socket 200 has a first end 202, a second end 204, and the
first end
202 has an opening 210 configured and dimensioned to receive at least a
portion of a residual
limb 190 of a user. The second end 204 is closed end 220 in a rounded type
orientation.
Optionally and/or alternatively, the second end has a hole or channel that
extends through the
thickness of the preformed socket 200. A cavity or partial channel is formed
extending from the
open first end 202 to the closed second end 204. The enclosed end 220 is
opposite to the
opening 210. The enclosed end 220 can have any type geometry, e.g., square,
rectangle, cone,
etc. The preformed socket has an outer circumference 230, which is smaller
than the inner
circumference of the rigid prosthetic socket 150. A difference between the
outer circumference
230 of the preformed socket 200 and the inner circumference (not shown) of the
rigid prosthetic
socket 150 (not shown) may be no more than 15%. In one embodiment, the
circumference 230
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of the preformed socket 200 can be determined based on the inner circumference
of the rigid
prosthetic socket 150 based on formula (1) herein or other techniques herein.
[0087] The preformed socket 200 has a length 240 that is equal to or larger
than the
corresponding length of the prosthetic socket 150, e.g., having a longer
length than the prosthetic
socket, thereby allowing the flexible inner socket 100 to be trimmed to a
predetermined shape
and geometry. In this embodiment, the preformed socket 200 has a thickness 250
in a range
from about 2 mm to about 8 mm. The thickness 250 of the preformed socket 200
can be
determined based on the desired inner circumference reduction of the
prosthetic socket 150.
[0088] Optionally and/or alternatively, a kit including multiple preformed
sockets 200
having different dimensions and shapes can provided to an end user to allow
the end user to form
multiple flexible inner sockets 100 that can provide different inner
circumference reductions to
the rigid prosthetic socket 100. The kit further can include instructions for
use, e.g., selection
and application of the different flexible inner sockets.
[0089] FIG. 3 illustrates a group of preformed sockets having different shapes
and
dimensions, in accordance with another embodiment.
[0090] Referring to FIG. 3, a group of preformed sockets is generally depicted
with
reference to preformed socket 310, preformed socket 320, preformed socket 330,
and preformed
socket 340. Each of these preformed sockets 310, 320, 330 and 340 have
different shapes and
dimensions.
[0091] Each of the preformed sockets 310, 320, 330, and 340 are different
embodiments
of the preformed socket 200 described with reference to FIGS. 2A-2D. Each of
the preformed
sockets 310, 320, 330, and 340 can be used to form a flexible inner socket
(e.g., the flexible inner
socket 100) that can be attached to the inner surface of a rigid prosthetic
socket (e.g., the rigid
prosthetic socket 150) to provide an inner circumference reduction to the
prosthetic socket.
Optionally and/or alternatively, the group of preformed sockets can include
any number of
preformed sockets.
[0092] The group of four preformed sockets 310, 320, 330, and 340 can include
a
different number of preformed sockets with different dimensions, thickness,
materials, lengths,
and other attributes described herein. In this embodiment, preformed sockets
310, 320, 330, and
340 have decreasing circumferences_ Preformed socket 310 has the largest
circumference and
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preformed socket 340 has the smallest circumference. Other dimensions, such as
length, of the
preformed sockets 310, 320, 330, and 340 can also be different. The preformed
sockets 310,
320, 330, and 340 can also have different shapes, such as more or less conical
shapes. The
preformed sockets 310, 320, 330, and 340 can have ends that are rounded or
oblong. They can
also have uniform thickness or have different thicknesses at different
portions. Optionally and/or
alternatively, the second end has a hole or channel that extends through the
thickness of the
preformed socket.
[0093] The preformed sockets 310, 320, 330, and 340 are used for forming
flexible inner
sockets of different sizes. These flexible inner sockets can provide different
inner circumference
reductions to the same rigid prosthetic socket or multiple rigid prosthetic
sockets of different
sizes. In some embodiments, a user may need a flexible inner socket of a
different size as
conditions of the user's residual limb change. For instance, the user's
residual limb can undergo
substantial changes in shape and volume during the postoperative recovery
period, during the
day or other times. As the shape or volume of the user's residual limb
changes, the user needs a
different amount of inner circumference reduction for comfortable fit of the
prosthetic socket.
The circumference of each of the preformed sockets 310, 320, 330, and 340 is
smaller than the
inner circumference of the rigid prosthetic socket so that it can be placed
into the prosthetics
socket for being molding onto the inner surface of the prosthetic socket. In
some embodiments,
the difference between the circumference of each of the preformed sockets 310,
320, 330, and
340 and the inner circumference of the rigid prosthetic socket is no more than
15% so that the
preformed sockets 310, 320, 330, and 340, after heated and stretched, can
match the inner
surface of the rigid prosthetic socket.
[0094] FIG. 4 illustrates a cross-sectional view of two preformed sockets,
each of which
has a uniform thickness, in accordance with another embodiment.
[0095] Referring to FIG. 4, two preformed sockets are generally depicted as
410 and 420.
Each of the preformed sockets 410 and 420 have a uniform thickness. Preformed
socket 410 has
a thickness 415 and preformed socket 420 has a thickness 420. Thickness 425 is
larger than
thickness 415. The thicknesses 415 and 425 can be in a range from about 2 mm
to about 8 mm.
[0096] In one embodiment, two or more preformed sockets, e.g., 410 and 420,
can be
used to form two flexible inner sockets of different thicknesses by molding
the preformed
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sockets 410 and 420 onto the inner surface of a same prosthetic socket. The
thickness of the
flexible inner sockets can be the same or similar to the thicknesses 415 and
425 and the
preformed sockets 410 and 420. The material of socket 410 and 420 can be the
same or
different.
[0097] In one embodiment, the two flexible inner sockets 410 and 420 can be
interchangeable and removable by a user from a prosthetic. As the flexible
inner sockets have
different thicknesses 415 and 425, they can provide different amounts of inner
circumference
reduction to the same rigid prosthetic socket for a user. For example, a user
can wear the flexible
inner socket formed from the preformed socket 410 when the user's residual
limb is engorged
and larger (e.g., typically in the morning a residual limb can have a larger
outer circumference),
and use the flexible inner socket formed from the preformed socket 420 when
the user's residual
limb is shrunk and fluid has been pressed out from the residual limb (e.g.,
typically in the
afternoon a residual limb of user can have a smaller circumference as compared
to the morning).
[0098] As the preformed sockets 410 and 420 have uniform thicknesses 415 and
425, the
flexible inner sockets provide uniform inner circumference reductions. The
thickness of a
preformed sockets can have a non-uniform distribution to form a flexible inner
socket providing
a non-uniform inner circumference reduction. Optionally and/or alternatively,
the second end
has a hole or channel that extends through the thickness of the preformed
socket.
[0099] FIG. 5 illustrates pre-sockets having non-uniform thicknesses, in
accordance with
another embodiment.
[00100]
Referring to FIG. 5, preformed
sockets 510, 520, and 530 are generally
depicted each having non-uniform thicknesses as depicted in each preformed
socket. Each of the
preformed sockets 510, 520, and 530 can be an embodiment of the preformed
socket 200 herein
or any embodiment herein. Each of the preformed sockets 510, 520, and 530 has
a different
thickness at different portions of the preformed socket.
[00101] Preformed socket 510 has a first end 502 and second end 504. The first
end 502
is enclosed 515 and the second end 504 is open 517. The thickness of the
preformed socket 510
gradually increases from the first end 502 to the second end 504.
[00102] Preformed socket 520 has a first end 506 and second end 508. The first
end 506
is enclosed 526 and the second end 508 is open 524. Preformed socket 520 has a
first end region
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527, a middle region 523 and a second end region 525. The first end region 527
has thickness
less than the thickness in middle region 523 and the middle region 523 less
than the thickness in
the middle region 523 and first end region 527. The thickness in first end
region 527, the
middle region 523 and the second end region 525 can be in a range from about 1
mm to about 8
mm or greater.
[00103] Preformed socket 530 has a first end 509, a second end 537, a left
side portion
535 and right side portion 537. The left portion 535 of the preformed socket
530 has a smaller
thickness than the right portion 537 of the preformed socket 530. The left
side portion 535 can
have a thickness in a range from about 2 mm to about 8 mm or greater and the
right side portion
537 can have a thickness in a range from about 2 mm to about 8 mm or greater.
Optionally
and/or alternatively, there can be greater thickness at specified locations,
such as where the bone
prominences, etc. tend to contact the flexible inner socket. In addition, the
thickness from a first
end 509 to a second end 511 does not have to be linear in its rate of change
from the first end 509
to the second end 511, e.g., the thickness can have any rate of change from a
first end 509 to a
second end 511, e.g., non-linear, linear or constant rate of change.
[00104] The thickness can be customized and optimized for a particular user's
shape of
their residual limb and features of the same, e.g., bone prominences, soft
spots, infection,
bruising, and the like. This customized and optimized thickness can be
determined with
computer scanner devices, manually with plaster molds, visually mapping, and
any combination
of the same or the like. This customized and optimized can also be adjusted in-
situ with tools
configured to remove thickness, e.g., grinder, sander and the like.
[00105] As the preformed sockets 510, 520, and 530 have non-uniform
thicknesses, they
can form flexible inner sockets of non-uniform thicknesses. These flexible
inner sockets, when
attached to the inner surface of a rigid prosthetic socket, can provide non-
uniform inner
circumference reductions and cause non-uniform compression of the residual
limb of a user
wearing the flexible inner socket and rigid prosthetic socket. With a larger
thickness of a portion
of the preformed socket, the corresponding portion of the flexible inner
socket can provide a
higher inner circumference reduction and the corresponding portion of the
user's residual limb
can be more compressed.
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[00106] In some embodiments, the non-uniform distribution of the thickness of
a primary
socket is determined based on the conditions of the user's residual limb, such
as shape,
dimension, as described herein. For instance, a portion of the user's residual
limb may have
more tissue or be stronger than other portions. This portion of the residual
limb can therefore
bear more weight of the user. The rigid prosthetic socket can have a more
comfortable fit if
more compression is applied to this portion of the residual limb. Accordingly,
the corresponding
portion of the preformed socket can be made thicker. The non-uniform
distribution of the
thickness of a primary socket can also be determined based on characteristics
of the user, such as
weight, BMI (body mass index), water retention, medical conditions, and the
like.
[00107] In one embodiment, to form a flexible inner socket from a preformed
socket, the
preformed socket is heated to a temperature so that the preformed socket
becomes a formable
preformed socket. The formable preformed socket is placed in the prosthetic
and molded onto
the inner surface of the prosthetic socket such that the outer circumference
of the formable pre-
socket substantially follows the contours of the inner surface of the
prosthetic socket, thereby
reducing the inner circumference of the prosthetic socket in a predetermined
manner based on
the thickness of the pre-socket to provide a globally reduced fit of the
prosthetic socket. As
described herein, the molding of the preformed socket can be done through
inserting pressure,
force, e.g., air, vacuum pressure or other external pressure can be used to
apply the pressure.
[00108] FIG. 6 illustrates an air inlet assembly used for molding a preformed
socket, in
accordance with another embodiment.
[00109] Referring to FIG. 6, an air inlet assembly 600 is used for molding a
preformed
socket 650. The preformed socket 650 is the preformed socket as described
herein, e.g., in FIGS
2A-2D. The preformed socket 650 has a closed first end 602 and open second end
604. The
second end 604 has an opening 660. The air inlet assembly 600 can be arranged
over the
opening 660 and seal the second end 604.
[00110] The air inlet assembly 600 includes a lid 610, a hose 620, and a clamp
630. In
other embodiments, the air inlet assembly 600 can include different components
that have similar
functions. The preformed socket 650 can also be made with an enclosed top that
has a small
opening for the hose 650 to insert into. The lid 610 seals the opening 660 of
the preformed
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socket 650. The lid 610 includes a lid cover 613, a valve 615, and a socket
connector 617. The
lid cover 613 is configured to be placed on the opening 660 of the preformed
socket 650.
1001111 The lid 610 has a top portion or cover 613 formed with a hole at a
central area of
the lid cover 613. The hole can include a valve 615, e.g., one-way valve, for
controlling air flow.
The valve 615 has a shape of a hollow cylinder. The valve 615 and the hole in
the lid cover 613
provide an air channel to the preformed socket 650. The socket connector 617
is coupled to the
lid cover 613 and can be inserted into the preformed socket 650 to make the
preformed socket
650 airtight. The socket connector 617 can be in a shape of a ring and can be
made of rubber or
other flexible materials. The socket connector 617 can have a top portion that
is coupled to the
lid cover 613 and a bottom portion that has a larger diameter than the top
portion.
1001121 In one embodiment, the hose 620 is coupled to the valve 615 of the lid
610. One
end of the hose 620 is inserted into the valve 615. Another end of the hose
620 can be connected
to a pump that pumps air into the preformed socket 650 through the hose 620.
[00113] The clamp 630 clamps the portion of the preformed socket 650 that
encloses the
socket connector 617 of the lid 610 to hold the lid 610 to the preformed
socket 650, particularly
the socket connector 617 of the lid 610, with the preformed socket 650.
1001141 FIGS. 7A-7D illustrate a process of molding a preformed socket onto an
inner
surface of a rigid prosthetic socket by using the air inlet assembly, in
accordance with another
embodiment;
1001151 Referring to FIGS 7A-7D, a preformed socket 650 is molded or arranged
onto an
inner surface of a prosthetic socket 700 by using the air inlet assembly 600
of FIG. 6 The air
inlet assembly 600 is installed on the preformed socket 650 and seals the
opening 660 of the
preformed socket 650.
[00116] Referring to FIG. 7B, in this step, the preformed socket 650 is heated
to a
temperature in a range from about 200 F to about 280 'F. The preformed socket
650 becomes
pliable due to the heating. The heated preformed socket 650 is placed into the
rigid prosthetic
socket 700.
1001171 Referring to FIG. 7C, in this step, air is inserted into the preformed
socket 650 by
using a pump, e.g., a hand ball pump, electric pump or the like to a molding
pressure. The
molding pressure may be any pressure from about 1 psi to about 8 psi or
greater. The pressure
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inflates the preformed socket 650 and presses the preformed socket 650 against
the inner surface
of the prosthetic socket 700. The air utilized may be heated air, cooled air
or a combination
throughout process.
[00118] The preformed socket 650 is molded onto the inner surface of the rigid
prosthetic
socket 700 by the internal pressure of the preformed socket, thereby
substantially conformally
forming the flexible inner socket 750 to the prosthetic socket. During the
molding, the
preformed socket 650 is stretched and shaped to fit the contour of the inner
surface of the rigid
prosthetic socket 700. The flexible inner socket 750 has a shape that matches
or substantially
matches the contours of the inner surface of the prosthetic socket 700. The
thickness of the
preformed socket 650 may not change or minimally changes during the molding
process. The
preformed socket 650 may be heated during the insertion of the air. Referring
to FIG. 7D, in this
step, the flexible inner socket 750 has been formed and can now be removed
from the prosthetic
socket 700.
[00119] In one embodiment, the preformed socket 650 may expand out of the
rigid
prosthetic socket 700 during the molding process. Also, the rigid prosthetic
socket 700 may
have a smaller length than the preformed socket 650, and a portion of the
preformed socket 650
is not enclosed in the rigid prosthetic socket 700 as shown in FIG. 7B. This
portion of the
preformed socket 650 is not constrained by the rigid prosthetic socket 700 and
may expand in an
undesired manner during the inflation, which can result in the flexible inner
socket 750 having an
undesired shape. Wraps can be used during the molding process to prevent
undesired expansion
of the preformed socket 650.
[00120] FIG. 8 illustrates wraps used for constraining a preformed socket
during molding
of the pre-socket, in accordance with another embodiment.
[00121] Referring to FIG. 8, illustrate wraps 810 and 820 used for
constraining a
preformed socket during molding of the preformed socket. The preformed socket
830 can be
molded onto the inner surface of a rigid prosthetic socket 830 using the
process described in
conjunction with FIGS. 7A-7D.
[00122] In this embodiment, a preformed socket is placed in the prosthetic
socket 830.
The wraps 810 and 820 constrain the preformed socket during its inflation by
the inserted air.
The wraps 810 and 820 can prevent the preformed socket from expanding out of
the opening of
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the prosthetic socket 830. Optionally and/or alternatively, one of either wrap
810 and 820 may
be used. The wraps 810 and 820 can be made from Velcro bands, fabric, polymer
or other
materials that provide the proper amount of constraint.
[00123] The wrap 810 circumferentially wraps a portion of the prosthetic
socket 830 to
constrain expansion of the preformed socket. The wrap 810 can also
circumferentially wraps a
portion of the preformed socket, such as a portion of the preformed socket
that is not enclosed in
the rigid prosthetic socket 830. The wrap 810 reduces circumferential
expansion of the
preformed socket.
[00124] The wrap 820 wraps the prosthetic socket 830 and is arranged over the
top
surface of the lid 845 of the air inlet assembly 840 the sides of the rigid
prosthetic socket 830,
and the bottom of the base 835 of the prosthetic socket 830. The preformed
socket is enclosed
within the lid 845 of the air inlet assembly 840 and the prosthetic socket
830, so that the wrap
820 prevents the preformed socket from expanding vertically along a y-axis.
[00125] FIG. 9 illustrates a process of molding a preformed socket onto an
inner surface
of a rigid prosthetic socket by using an air bag, in accordance with another
embodiment.
[00126] Referring to FIG. 9, a process of molding a preformed socket 910 onto
an inner
surface of a rigid prosthetic socket 920 by using an air bag 930 is generally
described. The
preformed socket 910 can be the preformed socket 200 or any preformed socket
described
herein. The prosthetic socket 920 can be a rigid prosthetic socket 150 or any
prosthetic socket
described herein.
[00127] In a first step, the preformed socket 910 is placed in the prosthetic
socket 920.
Next, the airbag 930 is placed in the preformed socket 910. The airbag 930 is
coupled to a hose
940, through which air source or pump can be coupled to the airbag 930. The
hose 940 is
coupled to a valve 950 that controls flow of the air. For instance, air can be
inserted into the air
bag 930 when the valve 950 is open and is prevented from flowing into the air
bag when the
valve 950 is closed.
[00128] The preformed socket 910 is heated before and/or while the air is
inserted into
the air bag 940 with heated air or other heat source. Due to the heating, the
preformed socket
910 is pliable and configured to move from a first orientation to a second
orientation. The airbag
940 is inflated by the air and press the preformed socket 910 against the
inner surface of the rigid
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prosthetic socket 920 to mold the material of the preformed socket 910 to a
contour of the inner
surface of the prosthetic socket 920. The molded shape is maintained when it
cools down to
room temperature. After it is cooled the pressure or air source is released.
[00129] FIG. 10A is a perspective view of a system of molding a preformed
socket onto
an inner surface of a rigid prosthetic socket by vacuum, in accordance with
another embodiment.
FIG. 10B is a cross-sectional view of the system, in accordance with another
embodiment.
[00130] Referring to FIGS. 10A-10B, a preformed socket 1010 is molded onto an
inner
surface of a prosthetic socket 1020 by vacuum pressure form a vacuum source
with an aid of a
sleeve 1030 and a vacuum hose 1040. The preformed socket 1010 is placed into
the prosthetic
socket 1020. A portion of the preformed socket 1010 is enclosed by the rigid
prosthetic socket
1020 and another portion of the preformed socket 1010 is outside the rigid
prosthetic socket
1020. For the portion of the preformed socket 1010 that is enclosed by the
prosthetic socket
1020, there is a gap between the outer surface of the preformed socket 1010
and the inner surface
of the prosthetic socket 1020 The gap is sealed by the sleeve 1030. As shown
in FIG. 10B, the
sleeve 1030 is applied on the rigid prosthetic socket 1020 and the portion of
the preformed
socket 1010 that is outside the rigid prosthetic socket 1020.
[00131] A vacuum hose 1040 is installed on the base 1050 of the rigid
prosthetic socket
1020. The vacuum hose 1040 provides a channel to the gap between the preformed
socket 1010
and the rigid prosthetic socket 1020. The vacuum hose 1040 is coupled to a
vacuum source (not
shown). In FIG. 10C, the air in the gap between the preformed socket 1010 and
the rigid
prosthetic socket 1020 is pumped out from the gap by the vacuum pump to create
a vacuum, or
near vacuum, in the gap. The preformed socket 1010 is pliable during creation
of the vacuum by
application of heat or previous application of heat that has been applied or
is being applied to the
preformed socket 1010. Due to the vacuum pressure, the preformed socket 1010
is pulled
toward the inner surface of the rigid prosthetic socket 1020 to mold onto the
inner surface of the
rigid prosthetic socket 1020 and to form a flexible inner socket.
[00132] FIG. 11 illustrates another system of molding a preformed socket onto
an inner
surface of a rigid prosthetic socket by vacuum, in accordance with another
embodiment.
[00133] Referring to FIG. 11, a preformed socket 1110 is molded onto an inner
surface of
a prosthetic socket 1120 by vacuum. The preformed socket 1110 is placed in the
prosthetic
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socket 1120 and a top portion 1115 of the preformed socket 1110 extends
outside the opening of
the prosthetic socket 1120. A flexible bladder 1130 is arranged around the
preformed socket
1110 and extends outside the opening of the prosthetic socket 1120 and is
folded around the top
portion 1125 of the prosthetic socket 1120 to cover a portion of the
prosthetic socket 1120.
1001341 In this embodiment, the flexible bladder 1130 wraps into the preformed
socket
1110 and over the top portion 1115 of the preformed socket 1110 and the top
portion 1125 of the
rigid prosthetic socket 1120_ As shown in FIG. 11, the flexible bladder 1130
covers the inner
surface of the preformed socket 1110, the outer surface of the top portion
1115 of the preformed
socket 1110, and the outer surface of the top portion 1125 of the prosthetic
socket 1120. The
flexible bladder 1130 provides a seal the gap between the preformed socket
1110 and the
prosthetic socket 1120. The flexible bladder is stretched over the top portion
115 and 1125.
1001351 The vacuum hose 1140 connects to a vacuum source (not shown) and is
operated
to create a vacuum pressure, or near vacuum pressure, in the gap. The vacuum
hose 1140 can be
the same as the vacuum hose 1040. Due to the vacuum pressure, the preformed
socket 1110 is
molded onto the inner surface of the rigid prosthetic socket 1120 and to form
a flexible inner
socket. Optionally and/or alternatively, the second end of the preformed
socket 1110 has a hole
or channel that extends through the thickness of the preformed socket. The
hole or channel (not
shown) allows the vacuum pressure to communicate directly with the preformed
socket through
the hole or channel. In this embodiment, the preformed socket is heated prior
to inserting into
the prosthetic socket to a thermoformable temperature. The preformed socket is
allowed to cool
and the vacuum source is turned off.
1001361 FIGS. 12A-12B illustrates a process of trimming a flexible inner
socket 1200, in
accordance with another embodiment.
1001371 Referring to FIG. 12A, a first flexible inner socket 1200 having a top
edge 1210
untrimmed extending above a prosthetic socket 1250 is shown. In FIG. 12B, the
top edge 1210
is trimmed to top edge 1215 to follow the top edge 1260 of the prosthetic
socket 1250. The
flexible inner socket 1200 is used to provide inner circumference reduction to
a rigid prosthetic
socket 1250. The flexible inner socket 1200 is formed by molding a preformed
socket onto the
inner surface of the rigid prosthetic socket 1250 as described in embodiments
herein.
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[00138] More specifically, the flexible inner socket 1200 has a top edge 1210
that forms
the opening of the flexible inner socket 1200. The rigid prosthetic socket
1250 has a top edge
1260 that forms the opening of the prosthetic socket 1250. An embodiment of
the flexible inner
socket 1200 can be the flexible inner socket 100, and an embodiment of the
rigid prosthetic
socket 1250 can be the prosthetic socket 150.
[00139] Before the trimming, the flexible inner socket 1200 has a flat top
edge 1210, as
shown in FIG. 12A. The trimming of the flexible inner socket 1200 includes
trimming the top
edge 1210 to make it match the top edge 1260 of the prosthetic socket 1250. As
shown in FIG.
12B, the trimmed top edge 1215 of the flexible inner socket 1200 has a contour
that is the same
as or similar to the contour of the top edge 1260 of the rigid prosthetic
socket 1250. In some
embodiments, the length of the flexible inner socket 1200 after the trimming
is larger than the
length of the rigid prosthetic socket 1250 so that the top edge 1215 of the
flexible inner socket
1200 can be bent, e.g., while being heated by a heat gun, to cover the top
edge 1260 of the rigid
prosthetic socket 1250. The flexible inner socket 1200 can be softer than the
rigid prosthetic
socket 1250 so that it is more comfortable for the user's residual limb to
contact the flexible
inner socket 1200 than the prosthetic socket 1250.
[00140] Even though the flexible inner socket 1200 is placed in the prosthetic
socket
1250 in FIGS. 12A-12B, the flexible inner socket 1200 can be removed from the
prosthetic
socket 1250 before the trimming.
[00141] FIG. 13 illustrates a flow chart of a process for fabricating a
flexible inner
socket, in accordance with another embodiment.
[00142] Referring to FIG. 13, the process of fabricating a flexible inner
socket is
generally shown. The flexible inner socket is used for reducing an inner
circumference of a
prosthetic socket, e.g., rigid, socket, that has previously been formed to fit
a residual limb of a
user. The process may include different or additional steps than those
described in conjunction
with FIG. 13 in some embodiments or perform steps in different orders than the
order described
in conjunction with FIG. 13_
[00143] A pre-socket is formed (step 1310) with a material. The pre-socket is
formed
with an opening and an enclosed end. The enclosed end is opposite the opening.
A
circumference of the body is smaller than the inner circumference of the
prosthetic socket. For
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example, the circumference of the body can be up to 15% smaller than the inner
circumference
of the rigid prosthetic socket.
[00144] In some embodiments, the thermoformable material is a polymer material
having
one or properties: an A-type duronaeter in a range from about 55 to about 85,
an elongation of at
least 300%, and a melting point below about 140 C. The material can be a
thermoplastic
elastomer material, a thermoplastic polyurethane (TPU) material, a
thermoplastic polyurethane
foam material, a thermoplastic vulcanizate (TPV) material, a rubber material,
an ultra-low
density polyethylene (ULDPE) material, an ethylene vinyl acetate (EVA)
material, a styrene
material and blends of the same, combination of the same or the like. The pre-
socket can be
formed through one more of injection molding, rotational molding, 3D printing
(e.g., fused
deposition modeling, selective laser sintering, or stereolithography), blow
molding, combinations
of the same and the like.
[00145] In some embodiments, a thickness of the pre-socket is pre-determined,
e.g.,
based on the dimensions of the prosthetic socket, shape and dimensions of the
user's residual
limb, the user's health conditions, or some combination thereof. In one
embodiment, the pre-
socket has a uniform thickness. In another embodiment, different portions of
the pre-socket have
different thicknesses as described herein.
[00146] In step 1320 the pre-socket is heated at a temperature between 90 C
to 140 C.
The pre-socket becomes pliable due to the heat. After the heating 1320, the
flexible inner socket
is formed 1330 by molding the pre-socket onto the inner surface of the rigid
prosthetic socket.
The rigid prosthetic socket has been formed to fit a residual limb of a user.
The rigid prosthetic
socket can be formed on the residual limb of the user or on a model of the
residual limb so that
the inner surface of the rigid prosthetic socket has a contour and dimensions
matching the
anatomical shape of the residual limb. No global reduction was applied to the
rigid prosthetic
socket during the forming of the rigid prosthetic socket.
[00147] In some embodiments, the pre-socket is molded onto the inner surface
of the
rigid prosthetic socket by inserting air into the pre-socket. The pre-socket
can be sealed with an
air inlet assembly to form an enclosed space. The sealed pre-socket is placed
in the rigid
prosthetic socket. Air is inserted into the pre-socket to inflate the pre-
socket. The air can press
the pre-socket against the inner surface of the rigid prosthetic socket to
form the flexible inner
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socket. In some other embodiments, the pre-socket is molded onto the inner
surface of the
prosthetic socket by creating vacuum pressure in a gap between the pre-socket
and the rigid
prosthetic socket. The vacuum pressure can pull the pre-socket toward the
inner surface of the
rigid prosthetic socket to form the flexible inner socket. The outer surface
of the formed flexible
inner socket has a contour and dimensions matching the contour and dimensions
of the inner
surface of the rigid prosthetic socket. The flexible inner socket can then be
cooled down, e.g., to
room temperature.
[00148] The flexible inner socket can be trimmed after being removed from the
rigid
prosthetic socket. For instance, the top edge of the flexible inner socket is
trimmed to match the
top edge of the rigid prosthetic socket. The flexible inner socket can be
placed into the rigid
prosthetic socket for use by the user.
EXAMPLES:
[00149] Without intending to limit the scope of the invention, the following
examples
illustrate how various embodiments of the invention may be made ancUor used.
Example 1:
[00150] This example illustrates the manufacture of flexible inner socket
according to an
aspect of the invention. A pre-socket was made with a thermoformable
polyurethane material
GLS Versaflex CE 3115 that was durometer 65K It was injection molded on a 500
ton injection
press. It was conical in shape and measured 30 cm tall, 11.5 cm diameter at
the open proximal
end, 94cm in diameter at the substantially closed distal end, and was 2.2 mm
thick uniformly
from the proximal end to the distal end.
[00151] A rigid heat formable injection molded prosthetic socket was provided
for a
below-the-knee amputee as described with reference to U.S.Patent Nos.
15/914,480 and
16/516,199, both of which are hereby incorporated by reference as if fully set
forth herein. The
rigid prosthetic socket was formed by heating it to 250 F. and forming it
directly to the users
residual limb, that had a gel/fabric liner applied, without the typical global
reduction being
applied. It included first end, a second end, an inner circumference. The
first end including
opening and the second end was substantially closed. The forming result was
that the inner
socket surface had contours that substantially mimic or matched contours of a
residual limb of
user. The rigid prosthetic socket was trimmed to size and the edges were
buffed and rounded.
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The pre-socket was slightly smaller externally than the rigid prosthetic
socket was internally so it
could be fit inside easily. The rigid prosthetic socket had a vacuum tube
attached to a small
opening in the distal end that was connected to an electric vacuum pump.
[00152] The pre-socket was heated with a Nutrichef infrared circulating oven
model no.
PKRT97 to 250 F for 10 minutes. It was suspended on an armature to hold it
shape and became
pliable yet not sticky or difficult to handle with gloves. The heated pre-
socket was inserted into
the rigid prosthetic socket which was room temperature. A flexible closed end
bladder was
quickly dropped inside the pre-socket and the open end was wrapped over the
top and fit tightly
to the outside of the rigid prosthetic socket forming a seal. The vacuum pump
was immediately
turned on and the resulting vacuum immediately pulled the heated pliable pre-
socket to the
interior shape of the rigid prosthetic socket in every detail. The pre-socket
was allowed to cool
while maintaining this shape under vacuum.
[00153] A marker was used to make a trim line that extended from I cm to 2 cm
above
the edge of the rigid prosthetic socket. The formed pre-socket was removed and
cut with shears
to shape. The edge was ground with a buffing tool to be smooth and rounded. A
small hole was
made in the distal end for the purpose of using a vacuum suspension retention
system to hold the
socket to the limb. It was inserted back inside the rigid prosthetic socket
and referred to as a
flexible inner socket. A heat gun was used to heat the edges of it to flare
them and accommodate
the needs of the user.
[00154] The resulting product was a flexible inner socket that globally
reduced the inner
circumference of the rigid prosthetic socket by about 4 % in a relatively
precise manner. Metal
fittings, a pylon, and prosthetic foot were attached. The user donned their
gel/fabric inner and
stepped into the device. It is critical that the global reduction compresses
the flesh and muscle in
a conical fashion thereby relieving pressure to the bone end and bearing the
users weight evenly
on the limb. The user walked on the prosthetic for several minutes and
proclaimed that it was
very comfortable and supported the weight away from the bone end adequately. A
proper global
reduction had been achieved.
[00155] After some more use, the user had some painful pressure on the distal
anterior
end as can often happen with use. The area was marked and the prosthetic was
removed. The
prosthetic socket, being heat formable, had the area heated with a heat gun
and the flexible inner
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socket was removed and also heated in the same area to about 225 'F. It was
quickly
reassembled and the user stepped in. The pressure point was relieved as the
limb pressed the heat
softened layers out. The pre-socket and prosthetic socket were cooled, and the
result was a very
comfortable good fitting prosthetic socket that the user was able to wear
successfully. Both the
pre-socket and the prosthetic socket are readily adjustable as described
herein.
[00156] The language used in the specification has been principally selected
for
readability and instructional purposes, and it may not have been selected to
delineate or
circumscribe the inventive subject matter. It is therefore intended that the
scope of the disclosure
be limited not by this detailed description, but rather by any claims that
issue on an application
based hereon. Accordingly, the disclosure of the embodiments is intended to be
illustrative, but
not limiting, of the scope of the disclosure, which is set forth in the
following claims.
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