U.S. patent application number 14/150161 was filed with the patent office on 2014-05-01 for amputation residuum device and method of using the same.
This patent application is currently assigned to Pando Innovations. The applicant listed for this patent is Pando Innovations. Invention is credited to Michael Joseph Astilla, Laura Brewer Riedel.
Application Number | 20140121784 14/150161 |
Document ID | / |
Family ID | 46637510 |
Filed Date | 2014-05-01 |
United States Patent
Application |
20140121784 |
Kind Code |
A1 |
Astilla; Michael Joseph ; et
al. |
May 1, 2014 |
AMPUTATION RESIDUUM DEVICE AND METHOD OF USING THE SAME
Abstract
An apparatus and method for post amputation residuum maintenance
and for preserving motion of the knee are provided. The apparatus
includes an elongated shell having a longitudinal axis and defining
a hollow interior closed at a distal end, the shell having an
opening extending from a proximal end and adapted to receive a
residuum into the interior of the shell, and a longitudinal slit
having a circular aperture at each end.
Inventors: |
Astilla; Michael Joseph;
(Durham, NC) ; Riedel; Laura Brewer; (Durham,
NC) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Pando Innovations |
Durham |
NC |
US |
|
|
Assignee: |
Pando Innovations
Durham
NC
|
Family ID: |
46637510 |
Appl. No.: |
14/150161 |
Filed: |
January 8, 2014 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
13398521 |
Feb 16, 2012 |
|
|
|
14150161 |
|
|
|
|
61443552 |
Feb 16, 2011 |
|
|
|
Current U.S.
Class: |
623/33 |
Current CPC
Class: |
A61F 2/7812
20130101 |
Class at
Publication: |
623/33 |
International
Class: |
A61F 2/78 20060101
A61F002/78 |
Claims
1. An apparatus for post amputation maintenance of a residuum
having a posterior portion, the apparatus comprising: an elongated
shell having a longitudinal axis extending from a proximal end to a
distal end and defining a hollow interior closed at the distal end,
the shell having an opening into the interior extending from the
proximal end and adapted to receive the posterior portion of the
residuum into the interior of the shell, and the shell having a
longitudinal slit having a circular aperture at each end and
extending substantially parallel to the longitudinal axis.
2. The apparatus of claim 1, wherein the shell has a second slit
extending substantially parallel to at least a portion of the
longitudinal slit.
3. The apparatus of claim 1, wherein a distal end of the
longitudinal slit is defined by the closed distal end of the
shell.
4. The apparatus of claim 3, wherein the shell has a second slit
having a distal end defined by the closed distal end of the
shell.
5. The apparatus of claim 4, wherein the distal end of the
longitudinal slit is positioned from about 0.5 inches to about 3
inches from the distal end of the second slit.
6. The apparatus of claim 1, further comprising a second shell
adapted to be positioned adjacent to the residuum, the second shell
configured to cover at least a portion of the opening of the
shell.
7. The apparatus of claim 6, wherein the second shell has a
longitudinal axis, and the second shell is substantially arcuate in
a cross-section taken transverse to the longitudinal axis of the
second shell.
8. The apparatus of claim 6, wherein the second shell comprises: an
inner foam layer comprising a soft material; and an outer foam
layer comprising a rigid material, wherein the outer layer is
positioned adjacent to the inner foam layer.
9. The apparatus of claim 8, wherein the peripheral edge of the
inner foam layer tapers outwardly.
10. The apparatus of claim 8, wherein the peripheral edge of the
outer foam layer tapers inwardly.
11. The apparatus of claim 1, wherein the shell comprises a
proximal portion including the proximal end of the shell, and a
distal portion including the distal end of the shell, wherein a
first width of the opening defined by the distal portion is greater
than a second width of the opening defined by the proximal portion
such that the width of the opening tapers inwardly from the
proximal end of the shell to the distal end of the shell.
12. The apparatus of claim 1, wherein the shell has a
circumference, and the opening is about 40% of the circumference of
the shell.
13. The apparatus of claim 1, further comprising: at least one
enclosure panel; and a means for securing the at least one
enclosure panel to the shell.
14. The apparatus of claim 1, further comprising a circular pad
disposed in the interior of the shell adjacent to the closed distal
end of the shell.
15. A method for maintaining a post amputation residuum including a
posterior portion, the method comprising: providing an elongated
shell having a longitudinal axis extending from a proximal end of
the shell to a distal end of the shell and defining a hollow
interior closed at the distal end, the shell having an opening into
the interior extending from the proximal end and adapted to receive
the residuum into the interior of the shell, and the shell having a
longitudinal slit having a circular aperture at each end and
extending parallel to the longitudinal axis; and positioning the
posterior portion of the residuum in the interior of the shell via
the opening.
16. The method of claim 15, further comprising the step of
providing a second shell adapted to be positioned adjacent to the
residuum, the second shell configured to cover at least a portion
of the opening.
17. The method of claim 16, further comprising the step of
positioning the second shell over at least a portion of the
residuum exposed through the opening in the shell.
18. The method of claim 16, further comprising the step of:
adjusting the position of the second shell to fit against the
residuum, wherein at least a portion of an edge of the first shell
defining the opening partially overlaps the second shell.
19. The method of claim 16, further comprising the step of:
trimming a portion of the second shell to accommodate the residuum
exposed through the opening in the shell.
20. The method of claim 15, wherein the shell has a second slit
extending parallel to at least a portion of the longitudinal
slit.
21. The method of claim 20, wherein a distal end of the
longitudinal slit is defined by the closed distal end of the shell
and wherein a distal end of the second slit is defined by the
closed distal end of the shell.
22. The method of claim 15, further comprising the steps of:
providing an enclosure panel; positioning the enclosure panel over
at least a portion of the residuum exposed through the opening in
the shell; and securing the enclosure panel to the shell.
23. The method of claim 15, further comprising the step of:
modifying the dimensions of the shell to accommodate the residuum
by trimming a portion of the shell.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application is a continuation application of U.S.
patent application Ser. No. 13/398,521 entitled "Amputation
Residuum Device and Method of Using the Same," filed Feb. 16, 2012,
which claims priority to U.S. Provisional Application No.
61/443,552 entitled "Post Amputation Residuum Maintenance and Knee
Range of Motion Preservation Apparatus," filed on Feb. 16, 2011,
the entire contents of both of which are incorporated by reference
herein.
BACKGROUND
[0002] Following amputation, edema often occurs in the amputated
region causing volume fluctuations in the residuum. It is often
important to stabilize the residuum by apply compression to the
residuum. The residuum may be placed in a splint or other device to
manage swelling and protect the residuum. Current devices are
formed from a continuous piece of plastic to form the posterior and
anterior portions and a distal end, where the anterior and
posterior portions are attached, such that variances in volume are
not appropriately accommodated at the distal end of the
residuum.
[0003] For all these reasons and others, there is a need for an
improved user-friendly device and method for accommodating residuum
volume fluctuations.
SUMMARY
[0004] Embodiments an amputation residuum device and method of
using the same are described herein which address these and/or
other. In some embodiments, the amputation residuum device
comprises a posterior shell having longitudinal slits formed
therein and a multidurometer, soft pre-tibial shell is provided.
The residuum device provides for a limb volume and diameter
variance accommodation via the floating pre-tibial shell and the
flexible posterior shell.
[0005] In some embodiments, an apparatus for post amputation
residuum maintenance is provided. The apparatus includes: an
elongated shell having a longitudinal axis and defining a hollow
interior closed at a distal end, the shell having an opening
extending from a proximal end and adapted to receive a residuum
into the interior of the shell, and a longitudinal slit having a
circular aperture at each end.
[0006] In some embodiments of the apparatus, the shell further
includes a second slit extending parallel to at least a portion of
the longitudinal slit. In other embodiments, a distal end of the
longitudinal slit is defined by the closed distal end of the shell.
In still other embodiments, the shell has a second slit having a
distal end defined by the closed distal end of the shell. In some
embodiments, the distal end of the longitudinal slit is positioned
from about 0.5 inches to about 3 inches from the distal end of the
second slit. In some embodiments, the apparatus includes a second
shell adapted to be positioned adjacent to the residuum, the second
shell configured to cover at least a portion of the opening of the
shell. In some embodiments of the apparatus, the second shell has a
longitudinal axis, and the second shell is substantially arcuate in
a cross-section taken transverse to the longitudinal axis of the
second shell.
[0007] In other embodiments, the apparatus further includes an
inner foam layer comprising a soft material; and an outer foam
layer comprising a rigid material, wherein the outer layer is
positioned adjacent to the inner foam layer. In still other
embodiments, the peripheral edge of the inner foam layer tapers
outwardly. In further embodiments, the peripheral edge of the outer
foam layer tapers inwardly.
[0008] In some embodiments of the apparatus, the shell has a
circumference, and the opening is about 40% of the circumference of
the shell. In other embodiments, the shell comprises a proximal
portion and a distal portion, wherein the width of the opening
defined by the distal portion is greater than the width of the
opening defined by the proximal portion. In further embodiments,
the apparatus further includes at least one enclosure panel; and a
means for securing that at least enclosure panel to the shell. In
other embodiments, the apparatus further includes a circular pad
disposed in the interior of the shell adjacent the closed end.
[0009] In some embodiments, method for maintaining post amputation
residuum maintenance is provided. The method includes: providing an
elongated shell having a longitudinal axis and defining a hollow
interior closed at a distal end, the shell having an opening
extending from a proximal end and adapted to receive a residuum
into the interior of the shell, and a longitudinal slit having a
circular aperture at each end; and positioning a residuum in the
interior of the shell via the opening. In other embodiments, the
method further includes the step of providing a second shell
adapted to be positioned adjacent to the residuum, the second shell
configured to cover at least a portion of the opening. In still
other embodiments, the method further includes the step of
adjusting the position of the second shell to fit against the
residuum, wherein at least a portion of an edge of the first shell
defining the opening partially overlaps the second shell. In
further embodiments, the method further includes trimming a portion
of the second shell to accommodate the residuum exposed through the
opening in the shell.
[0010] In some embodiments of the method, the shell has a second
slit extending parallel to at least a portion of the longitudinal
slit and a distal end of the longitudinal slit is defined by the
closed distal end of the shell and wherein a distal end of the
second slit is defined by the closed distal end of the shell. In
other embodiments, the method further includes the step of
positioning an enclosure panel over at least a portion of the
residuum exposed through the opening in the shell; and securing the
enclosure panel to the shell. In still other embodiments, the
method further includes the step of modifying the dimensions of the
shell to accommodate the residuum by trimming a portion of the
first shell
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] Having thus described embodiments of the invention in
general terms, reference will now be made the accompanying
drawings, wherein:
[0012] FIG. 1A is an exploded perspective view of an amputation
residuum device according to some embodiments;
[0013] FIG. 1B is a perspective view of a partially assembled
residuum device as shown in FIG. 1A;
[0014] FIG. 2 is a front elevation view of a partially assembled
residuum device as shown in FIG. 1A;
[0015] FIG. 3 is a rear perspective view of a portion of the
residuum device according to some embodiments of the invention;
[0016] FIG. 4 is a rear perspective view of another embodiment of
the residuum device;
[0017] FIG. 5 is a cross-sectional view of the pre-tibial shell in
FIG. 1B according to some embodiments of the invention;
[0018] FIG. 6 is another embodiment of a pre-tibial shell;
[0019] FIG. 7 is a cross-sectional view of the pre-tibial shell in
FIG. 6 according to some embodiments of the invention;
[0020] FIG. 8 is a top plan view of enclosure panels for a residuum
device according to some embodiments of the invention;
[0021] FIG. 9 is a rear plan view of the enclosure panels of FIG.
8; and
[0022] FIG. 10 is a perspective view of an enclosing means and a
residuum device according to some embodiments of the invention.
DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION
[0023] Embodiments of the present invention will now be described
more fully hereinafter with reference to the accompanying drawings,
in which some, but not all, embodiments of the invention are shown.
Indeed, the invention may be embodied in many different forms and
should not be construed as limited to the embodiments set forth
herein; rather, these embodiments are provided so that this
disclosure will satisfy applicable legal requirements. Where
possible, any terms expressed in the singular form herein are meant
to also include the plural form and vice versa, unless explicitly
stated otherwise. Like numbers refer to like elements
throughout.
[0024] Embodiments described herein provide a device and method for
amputation residuum maintenance. A device and method for
stabilization of an amputation residuum while accommodating
fluctuations in volume and diameter of the residuum are provided.
It will be understood that the term "residuum" as used herein
includes the remaining portion of an amputated body part, such as
an amputated limb and, in particular, a leg. When used with a limb,
such as a leg, the residuum device helps with knee range of motion
preservation. The residuum device described herein may be used for
human and animal residuum maintenance.
[0025] Referring now to the figures, FIGS. 1A-1B illustrate one
embodiment of an amputation residuum device 100. The residuum
device 100 includes a posterior shell 110, a pre-tibial shell 120,
enclosure panels 802, 804, and a circular pad 250.
[0026] The posterior shell 110 comprises a proximal portion 122 and
a distal portion 124 that extend along a longitudinal axis L of the
posterior shell 110 (see also, FIG. 2). The posterior shell 110 is
generally cylindrical in shape and includes an open end 130
positioned at the proximal portion of the posterior shell 110 and a
closed end 132 positioned at the distal portion of the posterior
shell 110. Although a closed distal end is shown and described
herein, it will be understood that both ends may be open. The
posterior shell 110 may have any length and diameter, which may be
adjusted to fit the amputation residuum. In some embodiments, the
posterior shell 110 is about 18 inches in length and about 5.5
inches in diameter along its length. The posterior shell 110 may
have any thickness and the thickness may vary along the length of
the proximal shell 110. For example, in some embodiments, the
proximal portion 122 of the posterior shell 110 has a greater
thickness in the proximal portion 122 than the distal portion
124.
[0027] Referring now to FIG. 2the posterior shell defines an
anterior opening 210 extending longitudinally from the proximal end
for exposing the hollow interior of the posterior shell 110. In
some embodiments, the width of the distal portion 124 of the
anterior opening 210 defines a region that is about 40% of the
circumference of the posterior shell 110. It will be understood
that the width of the distal portion 124 of the anterior opening
210 may be more or less than about 40% of the circumference of the
posterior shell 110 based on the desired rigidity or size of the
posterior shell 110. The length of the anterior opening 210, in
some embodiments, extends from the open end 130 to the closed end
132 along the longitudinal axis L of the posterior shell 110. In
some embodiments, the proximal portion of the posterior shell 110
comprises a first ear 220 and a second ear 222 that extend
circumferentially inwardly and are configured such that the width
of the anterior opening 210 at the proximal portion 122 is less
than the width of the anterior opening 210 at the distal portion
124.
[0028] In some embodiments, the posterior shell 110 is formed from
a semi-rigid polymer material that is shaped to comfortably
accommodate the posterior of a thigh, knee, and trans-tibial
residuum following amputation below the knee. Examples of the
semi-rigid polymer material include thermoplastics; polyolefins;
plastics; ethylene vinyl acetate, polypropylene, polyethylene,
polyethylene terephthalate, styrene, vinyl acetate, acrylonitrile,
polyvinyl chloride, polyamide, silicone, rubber, and carbohydrates
polymers or copolymers; cross-linked polymers or copolymers; and
combinations thereof. The posterior shell, in some embodiments, is
fabricated by thermo-forming the polymer material over a
cylindrical model. In other embodiments, the posterior shell is
formed by injection molding. The posterior shell 110 may be formed
in any color or opacity. For example, the posterior shell 110 may
be clear, slightly opaque, or completely opaque. In the case where
the posterior shell 110 is clear or slightly opaque, the position
of the floating pre-tibial shell 120 or any collecting fluids may
be visible from the outside of the posterior shell 110. Similarly,
anything positioned on the outside of the posterior shell 110, such
as fabric fasteners 850a-d, may be visible from the inside. To
enhance the comfort of the user, the inner surface of the posterior
shell 110 may be lined. For example, the posterior shell 110 may
include padding, wicking material, a gel layer, and the like.
[0029] Further shown in FIG. 2 is the circular pad 250 is disposed
at the closed end of the proximal shell. The pad 250 may be formed
from any soft, elastic, or conformable material. Examples of the
material used in the pad 250 include sponge, plastazote,
polypropylene terephthalate (PPT), foam, and the like.
[0030] Referring now to FIGS. 3 and 4, formed in the posterior
shell 110 are a first slit 236a and a second slit 236b as shown in
FIG. 3, and slits 236c and 236d shown in FIG. 4. The slits 236a,
236b or 236c, 236d allow for limited deformation of the shell to
accommodate volume and diameter variances of the residuum within
the posterior shell 110. The slits 236a-d may be formed by cutting
the posterior shell 110 using a knife, saw, blade, die, punch, or
the like. The slits 236a-d extend along the longitudinal axis of
the posterior shell 110.
[0031] Each of the slits 236a-d includes a first end and a second
end, the slits 236a-d having circular apertures 238a-h at each end
(see, e.g., FIGS. 2-4). The slits 236a, 236b and 236c, 236d, as
shown in FIG. 3 and FIG. 4, are formed in the posterior shell 110
and are positioned in parallel. The slits 236a and 236c are
positioned about 1 inch to about 5 inches from a first side edge
260a and slits 236b and 236d are positioned about 1 inch to about 5
inches form a second side edge 260b of the posterior shell 110,
where the side edges 260a, 260b extend along the longitudinal axis
L of the posterior shell 110 (see, FIG. 2). The diameter of the
circular apertures 238a-5h allows the gaps formed by the slits
236a-d to increase in width in response to an increase in residuum
volume or diameter. The length of the slits and distance from the
side edges may vary and any number of slits may be formed in the
posterior shell 110 in accordance with the size of the residuum
device 100 and volume and diameter fluctuations of the
residuum.
[0032] In FIG. 3, at least a portion of the first slit 236a and the
second slit 236b are positioned about 3 inches from the first side
edge 260a and the second side edge 260b of the posterior shell 110,
respectively. The slits 236a, 236b originate about 5 inches to
about 12 inches from the open end 130. At the point of origin, the
slits 236a, 236b are from about 2 inches to about 7 inches apart.
In some embodiments, the slits 236a, 236b are about 3 inches apart
at the point of origin. The slits 236a, 236b terminate at a first
point 304a and a second point 304b, respectively. The points 304a,
304b are positioned about 0.5 inches to about 3 inches apart at the
closed end 132 of the posterior shell 110. In some embodiments, the
points 304a, 304b are positioned about 1.5 inches apart.
[0033] In FIG. 4, the slits 236c, 236d are about 1.5 inches from
the first side edge 260a and the second side edge 260b of the
posterior shell 110, respectively. The slits 236c, 236d originate
about 5 inches to about 12 inches from the open end 130 and
terminate near the closed end 132. The slits 236c, 236d run
parallel along the longitudinal axis of the posterior shell 110
about 2 inches to about 7 inches apart.
[0034] Referring now to FIG. 5, the pre-tibial shell 120 includes
an inner foam layer 502 positioned adjacent to an outer foam layer
504. In some embodiments, the inner foam layer 502 is laminated to
the outer foam layer 504. The layers may be laminated using heat,
adhesive, or a combination thereof. The laminated foam layers may
then be cut to size, thermo-molded to a generally cylindrical
model, and beveled along all edges. In other embodiments, the
pre-tibial shell 120 is formed through an injection-molding
process.
[0035] The inner foam layer 502 is positioned against the
amputation residuum and, in some embodiments, comprises a soft
material. The outer foam layer 504 comprises a rigid, high density
material. This arrangement enhances the comfort and protection of
the user's limb. The foam used in the pre-tibial shell 120 may be
open cell foam, closed cell foam, polymer based foams, plant based
foams, or combinations thereof. Examples of the inner foam layer
502 and outer foam layer 504 include: polyolefin, polyether,
polyester, polyethylene, polypropylene, ethylene vinyl acetate,
rubber, polyimide, vinyl chloride, polyurethane, styrene, carbon,
soy, and cellulose based foams, and combinations thereof. The inner
foam layer 502 and outer foam layer 504 may further include any
number of additives or topical treatments such as antimicrobials,
water resistant additives, coloring agents, and the like. Although
two foam layers are illustrated in FIG. 5, it will be understood
that the pre-tibial shell 120 may include only a single layer or
any number of layers including additional foam layers or layers of
other materials. For example, the pre-tibial shell 120 may include
plastic, gel, fabric, and the like.
[0036] The pre-tibial shell 120 is configured to accommodate the
shape of the amputation resdiuum and provide a secure and
comfortable fit. As shown in FIG. 5, the thickness of the
pre-tibial shell 120 varies. In some embodiments, the inner foam
layer 502 has a beveled edge, tapering as it extends to the outer
side edges of the pre-tibial shell 120. In other embodiments, the
inner foam layer 502 tapers as it extends to the outer proximal and
distal edges. As further shown in FIG. 5, the inner foam layer 502
has a greater thickness than the outer foam layer 504. It will be
understood, however, that the inner foam layer 502 and outer foam
layer 504 may have any thickness as long as the pre-tibial shell
120 fits securely against the amputation residuum. As best shown in
FIGS. 1A and 1B, an upper portion adjacent the proximal end of the
pre-tibial shell 120. The upper portion defines an inner
indentation for receiving a knee of the user limb when a leg is
amputated below the knee.
[0037] FIG. 6 illustrates another embodiment of a pre-tibial shell
600 of the residuum device 100, which may be used in conjunction
with the posterior shell 110. The pre-tibial shell 600 can be
included in the residuum device 100 and may be used in conjunction
with the posterior shell 110. The pre-tibial shell 600 includes a
fastener strip 850e that is positioned on at least a portion of an
outer foam layer 704.
[0038] Referring to FIG. 7, the pre-tibial shell 600 comprises an
inner foam layer 702 and an outer foam layer 704. In some
embodiments, the outer foam layer 704 tapers inwardly as it extends
toward the outer edges of the pre-tibial shell 120 such that only
the inner foam layer 702 extends along the outer perimeter of the
pre-tibial shell 600. In other embodiments, the width of the upper
portion adjacent the proximal end of the pre-tibial shell 600 is
wider than the lower portion adjacent the distal end of the
pre-tibial shell 600.
[0039] Both embodiments of the pre-tibial shell 120, 600 may be
modified in any way. For example, the pre-tibial shell 120, 600 may
be easily trimmed or cut with scissors to better fit the user's
limb.
[0040] FIGS. 8 and 9 illustrate an enclosing means 800 for
enclosing an amputation residuum within the interior of the
posterior shell 110. The enclosing means 800 includes a first
enclosure panel 802, and optionally, a second enclosure panel 804.
The enclosure panels 802, 804 may be formed in any shape. In the
illustrated embodiments, the first enclosure panel 802 is
rectangular and the second enclosure panel 804 is trapezoidal. The
rear portions of the enclosure panels 802, 804 comprise soft fuzzy
or a "loop" type of fabric such that the rear potions may adhere to
the fastener strips 850a-e (FIG. 9). The enclosure panels 802, 804
may come in any color, size, shape, width, length, area, and
thickness. In the illustrated embodiments, the enclosure panels
802, 804 are rectangular in shape. In other embodiments, the
enclosure panels 802, 804 are 11 inches by 20 inches. The
dimensions of enclosure panels 802, 804 may be modified by trimming
the panels. Although two enclosure panels 802, 804 are illustrated,
it will be understood that a single enclosure panel or additional
panels may be provided. The enclosure panels 802, 804 are placed
over the fastener strips 850a-e to keep the enclosing means 800 in
place. The enclosure panels 802, 804, in some embodiments, include
one or more layers of fabric, foam, padding, rubber, neoprene,
elastic material, and the like. The enclosure panels 802, 804 may
be formed by cutting, die-cutting, or stamping the panels from a
roll of material. Other types of fastening systems may also be used
with the residuum device 100 such as clamps, straps, belts, tapes,
and the like.
[0041] In FIG. 10, the residuum device 100 is further illustrated
including the enclosing means 800. One or more of the enclosure
panels 802, 804, in some embodiments, are positioned across the
patella to enhance control over knee flexion. In some embodiments,
the enclosure panels 802, 804 and the fastener strips 850a-e
comprise fabric made of fastening material, such as hook and loop
type fasteners (e.g., "Velcro"). Referring to FIGS. 1A and 1B, the
fastener strips 850a-d are positioned on at least a portion of the
outer surface of the posterior shell 110. The fastener strips 850a
and 850c are positioned on the first ear 220 and the second ear
222, respectively. The fastener strips 850b and 850d are positioned
on the outer surface of the posterior shell 110 in the distal
portion 124. As described herein above, the second embodiment the
pre-tibial shell 600 may also include a fastener strip 850e that is
positioned on the outer surface of the pre-tibial shell 120.
[0042] The residuum device 100 can be used to accommodate an
amputation residuum. In use, the posterior shell 110 is applied to
the posterior of a patient's thigh and residual limb by positioning
at least a portion of the residuum into the hollow interior of the
posterior shell 110. As the posterior aspect of the posterior shell
110 is a continuous shell, the residuum device 100 will complete a
three point pressure configuration comprised of posterior thigh,
anterior patella, and posterior tibia in order to provide a knee
extension load. In some embodiments, the proximal potion 122
extends along at least a portion of the user's thigh and the distal
portion 124 extends along at least a portion of the user's tibia.
Depending on the length of the amputation residuum, the posterior
shell 110 may, for example, be trimmed at the open end 130.
[0043] The residual limb may be further accompanied by
postoperative dressings. The relative position of the posterior
shell 110 to the residuum is such that the distal end of the
residuum engages a pad placed in the closed end 132 of the residuum
device 100. The slits 236a, 236b or 236c, 236d formed in the
posterior shell 110 are configured to expand to avoid
over-compressing an often painful postoperative residuum. The
circular apertures 238a-h positioned at the ends of the
longitudinal slits 236a-d cause the slits 236a-d formed in the
posterior shell 110 to widen in response to volume and diameter
variations in the amputation residuum.
[0044] It will be understood that the residuum device 100 may be
used with or without the pre-tibial shell 120, 600 depending on the
needs or condition of the patient. In use, the pre-tibial shell 120
or 600 is positioned in the anterior opening 210 of the posterior
shell 110 such that the pre-tibial shell 120, 600 comes in contact
with the anterior aspect of the amputation residuum. In an
application where amputation is below the knee, the pre-tibial
shell 120, 600 is positioned such that the distal end of the
posterior shell 110 is adjacent the distal end of the residuum and
extending upwardly to the patella.
[0045] For a shorter trans-tibial residuum, the pre-tibial shell
120, 600 may be trimmed for removing material from its distal end
such that the pre-tibial shell 120, 600 is positioned more
distally. The pre-tibial shell 120, 600 is tucked into the
posterior shell in order to appropriately accommodate for volume
loss secondary to edema reduction within the residuum. For example,
in some embodiments, at least a portion of the posterior shell 110
defining the anterior opening 210 overlaps at least a portion of
the peripheral edges of the pre-tibial shell 120, 600. This allows
the posterior shell 110, when expanding or contracting in response
to volume and diameter variances in the amputation residuum, to
move relative to outer foam layer 504 of the pre-tibial shell 120,
600. When the pre-tibial shell 120,600 is adjacent to the
amputation residuum exposed through the anterior opening 210, the
pre-tibial shell 120, 600 floats to accommodate the amputation
residuum as it expands and contracts while it simultaneously
stabilizes the amputation residuum.
[0046] In some embodiments, the user's residuum is enclosed in the
proximal portion 122 of the posterior shell 110 by fastening the
first enclosure panel 802 to the posterior shell 110 over the
anterior of the patient's thigh. And the user's residuum is
enclosed in the distal portion 124 of the posterior shell 110 by
fastening the second enclosure panel 804 to the distal portion 124
of the posterior shell 110 and over the pre-tibial shell 120, 600
that has been appropriately applied to the anterior of the user's
residuum.
[0047] The residuum device 100 can be used in conjunction with any
number of additional items such as foam padding, a prosthetic sock
or prosthetic shrinker, straps, strapping apparatus and belt (e.g.,
fork strap and suspension belt), and the like. In particular, the
strapping apparatus and belt is useful when a user is upright,
standing, or ambulating, and the prosthetic sock can be used to
further protect the residuum and accommodate volume variance within
the residuum. In some embodiments, a kit is provided. The kit
comprises one or more of the posterior shells 110, pre-tibial
shells 120, 600, and enclosure panels 802, 804. In other
embodiments, the kit comprise packaging, a container, instructions,
labels, foam padding, a prosthetic sock or prosthetic shrinker,
straps, a strapping apparatus, and the like.
[0048] While certain exemplary embodiments have been described and
shown in the accompanying drawings, it is to be understood that
such embodiments are merely illustrative of, and not restrictive
on, the broad invention, and that this invention not be limited to
the specific constructions and arrangements shown and described,
since various other changes, combinations, omissions, modifications
and substitutions, in addition to those set forth in the above
paragraphs, are possible. Those skilled in the art will appreciate
that various adaptations and modifications of the just described
embodiments can be configured without departing from the scope and
spirit of the invention. For example, while the residuum device 100
is described herein for use with a leg, it will be understood that
the residuum device 100 may also be used for an arm or other body
part. Therefore, it is to be understood that, within the scope of
the appended claims, the invention may be practiced other than as
specifically described herein.
* * * * *