U.S. patent application number 11/716469 was filed with the patent office on 2007-07-19 for method and device for pressure offloading.
Invention is credited to Helen Rose Kimball.
Application Number | 20070163048 11/716469 |
Document ID | / |
Family ID | 39760580 |
Filed Date | 2007-07-19 |
United States Patent
Application |
20070163048 |
Kind Code |
A1 |
Kimball; Helen Rose |
July 19, 2007 |
Method and device for pressure offloading
Abstract
The present invention is a method and device for pressure
offloading in order to alleviate or diminish pressure on an area of
bony prominence, a blemish, wound, decubitus ulcer (also known as
pressure ulcer or pressure sore) or surgical site by elevating the
affected area above a surface without directly contacting the
affected area. An interior filling of the present invention is
composed of a Visco/Memory foam, natural buckwheat hulls, whole
buckwheat seeds, millet hulls, water, gel, silicone, Styrofoam
beads, a combination thereof, or other suitable material known in
the art. The interior filling is enclosed in a hollow member, and
an additional removable and/or reusable cover composed of
anti-bacterial/anti-microbial fabric, encloses the hollow member
for additional protection. Fastening means are attached to the
cover to allow the user to reconfigure the shape of the device to
provide the required support as needed for each use.
Inventors: |
Kimball; Helen Rose;
(Coconut Creek, FL) |
Correspondence
Address: |
JACQUELINE TADROS, P.A.
500 CYPRESS CREEK ROAD WEST
SUITE 500
FORT LAUDERDALE
FL
33309
US
|
Family ID: |
39760580 |
Appl. No.: |
11/716469 |
Filed: |
March 9, 2007 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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11230108 |
Sep 19, 2005 |
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11716469 |
Mar 9, 2007 |
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Current U.S.
Class: |
5/632 ;
5/648 |
Current CPC
Class: |
A61G 7/057 20130101;
A47C 20/021 20130101; A61G 7/065 20130101 |
Class at
Publication: |
005/632 ;
005/648 |
International
Class: |
A47G 9/00 20060101
A47G009/00 |
Claims
1. A pressure offloading device for elevating at least one portion
of a patient above a surface, the pressure offloading device
comprising: (a) an elongated, flexible hollow member having first
and second opposite ends, a longitudinal axis being defined there
between; (b) filling material contained within and substantially
filling the hollow member; and (c) fastening means disposed along
an outer side of the hollow member; whereby with the hollow member
formed into a desired shape and fastening means selected and
fastened together to maintain the hollow member in the desired
shape, the hollow member may be placed between the patient and the
surface such that at least a portion of the patient is elevated
above the surface, the hollow member supporting the patient
adjacent to but not in direct contact with said portion of the
patient.
2. The pressure offloading device of claim 1 wherein the hollow
member is comprised of a fabric material.
3. The pressure offloading device of claim 1 wherein the hollow
member is comprised of a water impervious elastomeric material.
4. The pressure offloading device of claim 1 wherein the hollow
member further includes closure means disposed along one side
thereof for providing access inside the hollow member.
5. The pressure offloading device of claim 1 wherein the hollow
member has a generally rectangular cross-section across the
longitudinal axis thereof.
6. The pressure offloading device of claim 1 wherein the hollow
member has a generally circular cross-section across the
longitudinal axis thereof.
7. The pressure offloading device of claim 1 wherein the filling
material comprises a viscoelastic polyurethane foam.
8. The pressure offloading device of claim 1 wherein the filling
material comprises buckwheat hulls.
9. The pressure offloading device of claim 1 wherein the filling
material comprises silicone.
10. The pressure offloading device of claim 1 wherein the filling
material comprises a gelatinous material.
11. The pressure offloading device of claim 1 wherein the filling
material comprises water.
12. The pressure offloading device of claim 1 wherein the filling
material comprises an upper layer of viscoelastic polyurethane
foam, a lower layer of viscoelastic polyurethane foam, and at least
one flexible inner support positioned between said upper and lower
layers.
13. The pressure offloading device of claim 12 wherein said
flexible inner support comprises a polyurethane material.
14. The pressure offloading device of claim 12 wherein said
flexible inner support comprises a polyethylene material.
15. The pressure offloading device of claim 1 wherein a flexible
rod is enclosed within said filling material.
16. A pressure offloading device for elevating at least one portion
of a patient above a surface, the pressure offloading device
comprising: (a) an elongated, flexible hollow member having first
and second opposite ends, a longitudinal axis being defined there
between; (b) filling material contained within and substantially
filling the hollow member; and (c) a flexible, removable cover
adapted to snuggly fit over the hollow member, the removable cover
having first and second opposite ends, a longitudinal axis being
defined therebetween, and fastening means disposed along an outer
side thereof, whereby with the removable cover encompassing the
hollow member, the hollow member formed into a desired shape, and
fastening means selected and fastened together to maintain the
hollow member in the desired shape, the hollow member may be placed
between the patient and the surface such that at least a portion of
the patient is elevated above the surface, the hollow member and
cover supporting the patient adjacent to but not in direct contact
with said portion of the patient.
17. The pressure offloading device of claim 16 wherein the
removable cover is made of an anti-bacterial and anti-microbial
fabric.
18. The pressure offloading device of claim 16 wherein the
removable cover further includes closure means disposed along a
side thereof for providing access inside the removable cover.
19. The pressure offloading device of claim 16 wherein the hollow
member is comprised of a water impervious elastomeric material.
20. The pressure offloading device of claim 16 wherein the hollow
member and the removable cover each have a generally rectangular
cross-section across the longitudinal axis thereof.
21. The pressure offloading device of claim 16 wherein the hollow
member and the removable cover each have a generally circular
cross-section across the longitudinal axis thereof.
22. The pressure offloading device of claim 16 wherein the filling
material comprises a viscoelastic polyurethane foam.
23. The pressure offloading device of claim 16 wherein the filling
material comprises buckwheat hulls.
24. The pressure offloading device of claim 16 wherein the filling
material comprises silicone.
25. The pressure offloading device of claim 16 wherein the filling
material comprises a gelatinous material.
26. The pressure offloading device of claim 16 wherein the filling
material comprises water.
27. The pressure offloading device of claim 16 wherein the filling
material comprises an upper layer of viscoelastic polyurethane
foam, a lower layer of viscoelastic polyurethane foam, and at least
one flexible inner support positioned between said upper and lower
layers.
28. The pressure offloading device of claim 27 wherein said
flexible inner support comprises a polyurethane material.
29. The pressure offloading device of claim 27 wherein said
flexible inner support comprises a polyethylene material.
30. The pressure offloading device of claim 16 wherein a flexible
rod is enclosed with said filling material.
31. A pressure offloading device for elevating a ball and a heel of
a patient's foot above a surface, the pressure offloading device
comprising: (a) an elongated, flexible hollow member having an
outer side that includes at least a top surface and a bottom
surface, a first hollow region and a second hollow region each
traversing the hollow member from the top surface to the bottom
surface, the hollow member forming substantially a figure-8 shape;
(b) filling material contained within and substantially filling the
hollow member; and (c) fastening means disposed along the outer
side of the hollow member; whereby with the patient's foot fastened
to the top surface with the fastening means, the ball of the foot
being over the first hollow region and the heel of the foot being
over the second hollow region, the ball and heel of the patient's
foot are elevated above the surface, the hollow member supporting
the foot adjacent to but not in direct contact with the ball and
the heel of the foot.
32. A method of elevating at least one portion of a patient above a
surface, comprising the steps of: (a) providing a pressure
offloading device comprising an elongated, flexible hollow member
having first and second opposite ends, a longitudinal axis being
defined there between; filling material contained within and
substantially filling the hollow member; and fastening means
disposed along an outer side of the hollow member; (b) forming the
hollow member into a desired shape (c) selecting fastening means
and fastening same together to maintain the hollow member in the
desired shape; and (d) placing the hollow member between the
patient and the surface such that at least a portion of the patient
is elevated above the surface, the hollow member supporting the
patient adjacent to but not in direct contact with said portion of
the patient.
33. The method of claim 32 wherein the portion of the patient that
is elevated is the patient's coccyx.
34. The method of claim 32 wherein the portion of the patient that
is elevated is at least one of the patient's heels.
35. The method of claim 22 wherein the portion of the patient that
is elevated is at least one of the patient's ankles.
36. The method of claim 32 wherein the portion of the patient that
is elevated is at least one of the patient's hips.
37. The method of claim 32 wherein the portion of the patient that
is elevated is at least one of the patient's ears.
38. A method of elevating a ball and a heel of a patient's foot
above a surface, comprising the steps of: (a) providing an
elongated, flexible hollow member having an outer side that
includes at least a top surface and a bottom surface, a first
hollow region and a second hollow region each traversing the hollow
member from the top surface to the bottom surface, the hollow
member forming substantially a figure-8 shape; filling material
contained within and substantially filling the hollow member; and
fastening means disposed along the outer side of the hollow member
(b) placing the ball of the patient's foot over the first hollow
region on the top surface of the hollow member, and the heel of the
patient's foot over the second hollow region on the top surface of
the hollow member; and (c) fastening the foot to the hollow member
with the fastening means.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] We hereby claim benefit under Title 35, United States Code,
Section 120 of U.S. patent application Ser. No. 11/230108 filed on
Sep. 19, 2005 (hereinafter "Prior Application"). This application
is a Continuation-in-Part of the Prior Application. The Prior
Application is currently pending. The Prior Application is hereby
incorporated in its entirety by reference into this
application.
FIELD OF THE INVENTION
[0002] This invention relates generally to the treatment, healing
and prevention of wounds, and more particularly' to a method and
device for alleviating or diminishing pressure on a bony
prominence, wound, blemish, decubitus ulcer (also known as pressure
ulcer or pressure sore) or surgical site.
BACKGROUND OF THE INVENTION
[0003] Chronic wounds are a great burden to healthcare and account
for billions of dollars in healthcare costs annually.
[0004] Pressure sores are a localized area of damaged tissue.
Pressure sores occur when soft tissue between a bony prominence and
an external surface is compressed for an extended amount of time.
Pressure sores, also known as bed sores or decubitus ulcers usually
occur from confinement to a bed, chair or wheelchair. In many
instances, pressure sores are a secondary result of another illness
or condition that leaves a person immobile.
[0005] Patients who are immobile tend to lie in one position for
hours on end. This causes a decrease in blood circulation to
certain pressure points on the body known as "bony prominences",
such as, for example, ears, shoulders, hips, coccyx (tail bone),
buttocks, elbows, ankles and heels, to name a few. These areas are
typically the first to break down. The tissue closest to the bone
is the most susceptible to pressure sores so a visible skin
discoloration may indicate the beginning stages of a pressure sore.
The tissue begins to decay from lack of blood circulation. This is
the basic formation of decubitus ulcer development. Thus, a lesion
or a pressure sore may develop on skin and underlying tissue due to
unrelieved pressure over a bony prominence.
[0006] The prevalence of pressure sores in the United States alone
is estimated to be between 1.5 to 3.0 million people. Every year an
estimated 60,000 people die from a IS bedsore complication. An
aging population, an increase in diabetes and a nursing shortage
have also contributed to an increase in pressure ulcers.
[0007] Pressure sores will appear as a red area that can develop
into an open wound if left without medical treatment. If pressure
sores are left untreated, they can lead to severe health
complications and even death.
[0008] A decubitus ulcer or pressure sore can range from a very
mild pink coloration of the skin, which disappears in a few hours
after pressure is relieved on the area, to a very deep wound
extending to and sometimes through a bone into an internal organ.
These ulcers, as well as other wound types, are classified in
stages according to the severity of the wound.
[0009] The usual mechanism of forming a decubitus ulcer is from
pressure. However, it can also occur from friction, such as by
rubbing against a bed sheet, cast, brace, or the like.
[0010] The pressure sore and the affected area must be kept clean
and clear of any dead tissue. Because pressure sores can expose a
patient to infection entering the blood stream, a potentially
deadly condition called sepsis, medical care is a very necessary
and worthwhile precaution. It has been reported in fact, that
sepsis is the 11.sup.th leading cause of death, overall.
[0011] The goal in the treatment, healing and prevention of
pressure sores is to relieve the pressure on and around bony
prominences. This can be accomplished by increasing air flow and
blood flow to the affected area so that pressure sores do not
continue to worsen.
[0012] Thus, pressure management is a critical part of a successful
treatment program. Redistributing pressure away from a wound or an
area of bony prominence aids in the treatment and prevention of
pressure ulcers.
[0013] Support devices can help relieve some of the pressure on the
pressure sores. Wound care products comprise devices for open wound
support, such as medicated dressings, wraps, protectors, mattress
pads and cushions.
[0014] Although these devices and treatments are helpful, they
remain ineffective in many respects. Dressings and wraps, for
example, are in direct physical contact with the wound surface.
Consequently, these devices apply pressure on the wound area. This
pressure results in a longer healing time and the affected areas
are therefore more prone to the formation of decubitus ulcers.
[0015] Mattress pads and cushions also have considerable drawbacks.
The mattress pads and cushions available today have a definite
geometrical shape and size which cannot be easily altered to adapt
to individual needs.
[0016] Wound protectors are typically used during the
transportation of accident victims. These protectors often cannot
be applied to bed sores or some surgical sites because of their
limited design.
[0017] Thus, there is clear and distinct need for a device which
will effectively alleviate or diminish pressure on a wound while
also avoiding direct physical contact with the wound, blemish,
pressure ulcer or surgical site.
[0018] It is known in the art to use a cushioning means for the
purpose of elevating the body and increasing air flow to pressure
points, thereby reducing the incidence of pressure or decubitus
ulcers.
[0019] For example, U.S. Pat. No. 5,511,260 (to Dinsmoor III et
al.) and U.S. Pat. No. 4,614,000 (to Mayer), U.S. Pat. No.
4,959,059 (to Eilender), U.S. Pat. No. 4,962,769 (to Garcia), U.S.
Pat. No. 5,462,519 (to Carver) and U.S. Pat. No. 4,425,676 (to
Crane), teach a mattress replacement or treatment overlay for the
purpose of elevating the body and increasing air flow to certain
pressure points, thereby reducing the incidence of pressure or
decubitus ulcers.
[0020] These cushioning means, however, are large and bulky and
cannot be easily manipulated to alter their shape or size to
accommodate individual needs.
[0021] U.S. Pat. No. 4,779,297 (to Sturges), teaches a compact
cushion support article for the purpose of elevating the body,
increasing air flow to pressure points, and thereby reducing the
incidence of pressure or decubitus ulcers.
[0022] These devices however, are of limited use, since their shape
and size cannot be altered and manipulated with ease. A device with
a defined geometric shape, for example, a donut, can not be
converted to adopt alternate shapes, for example, a linear, S-shape
or U-shape. Hence its usefulness is limited.
[0023] Similarly, the "Waffle Extended Care Cushion" from EHOB,
Inc., although compact, cannot be manipulated with ease to adopt a
different shape or size.
[0024] U.S. Patent Application No. 20030163072 (to Cristian Hueso)
teaches a conic arch device that provides physical protection to
any superficial wound. However, as with the "donut" and "waffle"
shaped cushions, the shape of this device is not capable of being
easily altered and cannot be adapted to accommodate individual
needs.
[0025] U.S. Pat. No. 6,009,577 (to Day), U.S. Pat. No. 5,638,564
(to Greenwalt), U.S. Pat. No. 5,615,432 (to Van Ohlen III) and U.S.
Pat. No. 6,595,935 (to Gerstmar) teach that it is known in the art
to have a crescent or U-shaped type pillow as a cushioning means
for the head and neck. These devices, however have not been adapted
for the treatment or prevention of pressure sores, decubitus
ulcers, etc.
[0026] Thus, there is a definite, distinct, and even urgent need
for a device in the treatment of decubitus ulcers, wounds,
blemishes, etc. which will redistribute and alleviate pressure from
a wound or area of bony prominence, without covering the wound,
blemish, pressure ulcer or surgical site and which is capable of
easily being manipulated to conform to individualized needs.
[0027] The present invention accomplishes these objectives and
substantially departs from the conventional concepts and designs of
the prior art.
SUMMARY OF THE INVENTION
[0028] The present invention solves the foregoing problems by
providing a method and device for the treatment and prevention of
wounds.
[0029] In view of the foregoing disadvantages in the treatment of
wound care, the present invention discloses a method and device for
offloading pressure by elevating an area of bony prominence or a
wound site, without covering the bony prominence or the wound. Thus
by redistributing and off-loading pressure, pressure to the bony
prominence or wound site is alleviated. The affected area is
elevated by the device and method of the present invention, while
avoiding direct contact with the wound or covering the wound, bony
prominence, pressure ulcer or surgical site.
[0030] Eliminating pressure while also avoiding covering the wound,
allows increased air flow and blood circulation to the critical
areas which alleviates and ideally prevents the occurrence of
decubitus ulcers.
[0031] The present invention comprises a material that conforms to
a body's shape and provides a custom molding or shaping type
effect, such as, for example, visco/memory foam, buckwheat hulls,
millet hulls, water, gel, silicone, and the like, enclosed in a
protective sheath. An additional removable cover may be placed over
the protective sheath and can be washed, sterilized and
re-used.
[0032] A feature of the present invention is the use of tie strips,
hook-and-loop fastener ("Velcro") strips or other fastening means
known in the art. The tie strips, Velcro strips or other fastening
means are attached to the external cover to adjust the shape of the
device in order to accommodate individualized and specific
needs.
[0033] An object of the present invention is to provide a device
for alleviating pressure from surface wounds which overcomes the
shortcomings of the prior art in wound treatment.
[0034] An advantage of the present invention is that it provides a
method to redistribute or offload pressure from a wound to allow
increased air flow and blood circulation to aid in the treatment
and prevention of wounds and pressure sores.
[0035] An object of the present invention is to keep critical
pressure points above a surface, such as bedding.
[0036] An advantage of the disclosed invention is that it is
proactive in the prevention of pressure ulcers and not merely
reactive.
[0037] An object of the present invention is to provide a
convenient, adjustable, malleable, portable, transportable and easy
to use device and method in the treatment and prevention of wound
care. The device of the present invention may be manipulated with
greater ease and frequency, in order to prevent injury and promote
healing.
[0038] Another object of the method of the present invention is to
surround a critical area such as a wound or bony prominence without
covering the critical area.
[0039] Another object of the present invention is to elevate an
affected area above a surface, thereby eliminating direct contact
between the wound and the surface, diminishing pressure on the
wound
[0040] Another object of the present invention is to alleviate
pressure from surface wounds with a device whose geometric shape
and size can be altered with ease in order to accommodate different
wound sites.
[0041] Another object of the present invention is to diminish
pressure from surface wounds with a device that is light weight and
easy to handle.
[0042] Other objects and advantages of the present invention will
become obvious to the reader and it is intended that these objects
and advantages are within the scope of the invention.
[0043] It is noted that the term wound as used throughout this
application, includes but is not limited to, wounds from injuries,
lesions, gashes, sores, abrasions and the like. Further, the terms
wound, blemish, decubitus ulcer, pressure ulcer, pressure sore and
surgical site are used interchangeably throughout this
application.
[0044] There has thus been outlined, rather broadly, the more
important features of the invention in order that the detailed
description thereof may be better understood, and in order that the
present contribution to the art may be better appreciated. Other
features and advantages of the present invention will become
apparent from the following more detailed description, taken in
conjunction with the accompanying drawings, which illustrate, by
way of example, the principles of the invention.
DESCRIPTION OF THE DRAWINGS
[0045] FIG. 1A is a perspective view of an embodiment of the
invention having a generally circular cross section cushion, the
cushion shown partially removed from a protective hollow member
8;
[0046] FIG. 1B is a perspective view of an embodiment of the
invention having a generally square cross section cushion, the
cushion shown partially removed from the protective hollow member
8;
[0047] FIG. 2A is a cross-sectional view of the invention, taken
generally along lines 2A-2A of FIG. 1A;
[0048] FIG. 2B is a cross-sectional view of the invention, taken
generally along lines 2B-2B of FIG. 1B;
[0049] FIG. 3 is a perspective view of the embodiment of the
invention having a circular cross shape cushion manipulated so as
to form a U-shape;
[0050] FIG. 4 is a perspective view of the embodiment of the
invention having a square cross shape cushion manipulated so as to
form an L-shape, to illustrate that the invention may be
manipulated to form a variety of different shapes;
[0051] FIG. 5 is a perspective view of an embodiment of the present
invention having an inner longitudinal core, and illustrated
without the protective hollow member 8;
[0052] FIG. 6 is a perspective view of another embodiment of the
present invention comprising three layers of filling material, such
as two outside layers of memory foam and an inner layer of
polyethylene or polyurethane, and illustrated without the
protective hollow member 8;
[0053] FIG. 7 is a perspective view of an alternate embodiment of
the present invention, partially cut away to reveal foam within the
hollow member, particularly adapted for foot, illustrated in
phantom outline, while in the standing position;
[0054] FIG. 8 is a side elevation view of a patient laying on the
device, and a bed sore area of the patient elevated above and not
touching the bed surface;
[0055] FIG. 9 is a perpective view of a patient laying on the
device, and a bed sore area of the patient elevated above and not
touching the bed surface;
[0056] FIG. 10 is a perspective view of the device surrounding and
not covering an area of bony prominence, such as a coccyx, showing
the coccyx elevated above and not touching the bed surface;
[0057] FIG. 11 is a perspective view of a patient laying on the
device, with areas of bony prominence, such as heels and ankles,
elevated above and not touching the bed surface; and
[0058] FIG. 12 is a perspective view of a patient laying her head
on the device, with an area of bony prominence, such as an ear,
elevated above and not touching the bed surface.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0059] Referring to FIGS. 1A-1B, a device for alleviating or
diminishing pressure from wounds according to an embodiment of the
present invention is identified generally at reference number
1.
[0060] A filling material is encased in a hollow member 8. The
filling material shown in FIGS. 1A-1B is a foam 16. Alternatively,
the filling material may include for example, buckwheat hulls,
millet hulls, water, gel, silicone or other material that conforms
to a body's shape and provides a custom molding or shaping type
effect.
[0061] The foam 16 is rolled in the general form of a circle as in
FIG. 1A. Alternatively, the foam may be shaped to form a square, as
in FIG. 1B, triangle (not shown), or any other suitable
cross-section shape. An acid free multi purpose spray adhesive,
such as ELMER'S Craft Bond (not shown), or other adhesive material
commonly known in the art, is used to maintain the shape of the
foam 16. The adhesive is applied to the foam 16 prior to shaping
the foam 16. Once the foam 16 is molded to the desired shape, it is
allowed to set for a suitable duration of time to allow the
adhesive to cure. Alternatively, a slab of foam 16 of the desired
thickness may be cut to the desired cross-sectional shape, such as
for example, a circle or square, by any suitable means known in the
art.
[0062] The hollow member 8 is preferably composed of a plastic film
or other suitable material and forms an overlay that acts as a
protective barrier. As normally used, the hollow member 8 fully
encloses the filling material, but may include either an open end
(as illustrated) or a longitudinal opening, such opening closable
by a closure means such as a zipper, or the like (not shown). As
noted, the filling material may be of varying cross-section shapes
and lengths. The hollow member 8 is preferably covered with a
removable protective sheath or casing 2 composed of
anti-bacterial/anti-microbial fabric as is known in the art, to
protect the hollow member 8 and keep the hollow member 8 from
getting soiled.
[0063] Tie strips, such as for example, VELCRO strips, identified
generally at reference number 5, or other suitable fastening means
known in the art are attached to the removable protective sheath 2.
The strips 5 are used to adjust the geometrical shape and size of
the device 1 as shown in FIG. 3.
[0064] FIGS. 2A and 2B show cross-sectional views across
longitudinal axes of a circular cross-section shape of foam 16 and
a square cross-section shape of foam 16, respectively. An alternate
filling material such as for example, air, styrofoam beads, water,
gel, silicone, buckwheat hulls, whole buckwheat seeds, millet hulls
or any combination thereof may also be used in place of the foam
16, with the density and composition of the filling variable to
accommodate specific needs and body parts.
[0065] FIG. 3 shows a perspective view of the embodiment of the
invention composed of foam 16 with the circular cross-section
cushion illustrated in FIG. 1A and manipulated to form a U-shape,
the U-shape held in place by fastening means such as tie strips
5.
[0066] FIG. 4 shows a perspective view of the embodiment of the
invention having foam 16 with the square cross-section cushion
illustrated in FIG. 1B and manipulated to form an L-shape, the
L-shape held in place by a fastening means, such as tie strips
5.
[0067] FIG. 5 is a perspective view of an embodiment of the present
invention in which a flexible rod 6 is provided in an aperture 7 in
the device 1. The rod 6 may be comprised of a flexible plastic or
other suitable material. As shown in FIG. 5, in this embodiment the
device 1 has a circular cross-section comprised of foam 16. The rod
6 provides a solid support and is composed of a flexible plastic or
other suitable material such that it bends freely when the device 1
is manipulated to form various shapes to accommodate a patient
3.
[0068] FIG. 6 is a perspective view of another embodiment of the
present invention comprising three distinct layers of filling
material. As shown, the device 1 is comprised of a top 16a, bottom
16b, and middle 16c layer. The top 16a and bottom 16b layers are
preferably comprised of foam 16, and the middle layer 16c is
preferably comprised of polyethylene, polyurethane or other
suitable material and provides a flexible inner support.
[0069] FIG. 7 shows a perspective view of an alternate embodiment
of the present invention particularly adapted to elevate the bony
prominences in a foot (shown in phantom outline), namely a heel 3b
and a ball 3f of a foot. In this embodiment the hollow member 8
includes a top surface 20 and a bottom surface 21. The filling
material, such as the foam 16, assumes the shape of the hollow
member 8 in this embodiment, or, alternately, the foam 16 and
hollow member 8 are integrally formed. The hollow member 8 includes
a first hollow region 14a for the ball 3f of the foot and a second
hollow region 14b for the heel 3b of the foot, thereby forming
generally a figure-8 shape. Tie strips 5 or other fastening means
are used to secure the device 1 to the foot, with the ball 3f of
the foot being over the first hollow region 14a, and the heel 3b of
the foot being held over the second hollow region 14b, such that
the ball 3f and heel 3b of the foot are not in contact with the top
surface 20. As such, this embodiment supports the foot adjacent to
but not in direct contact with the ball 3f and the heel 3b of the
foot.
[0070] FIGS. 8-12 show a patient 3 as utilizing the present
invention. The device 1 is placed between the patient 3 and the
surface 9 in order to elevate a portion of the patient 3 above the
surface 9.
[0071] The pressure offloading device 1 is manipulated as in FIG.
8, to rest between the patients' lower extremities 15 thereby
elevating at least four areas of "bony prominence"; both ankle 3b
and heel 3c regions, above the surface 9.
[0072] In FIGS. 9-12, the device 1 is manipulated to rest between
the patient 3 and the surface 9 in order to elevate the coccyx 3a,
heels 3b, ankles 3c, a hip 3d or an ear 3e.
[0073] The device 1 may be adjusted and manipulated to take varying
shapes by using the tie strips 5 or other fastening means known in
the art.
[0074] The cross sectional shape of the foam 16 may be of varying
shapes and sizes. For example, the foam 16 may have a circular
cross section as shown in FIG. 1A or a square cross section as
shown in FIG. 1B, as well as other suitable shapes and sizes not
herein indicated but known in the art. The filling material
provides the support required to elevate the body, such that the
wound is not in direct contact with a surface 9, such as bedding
material or the like.
[0075] An alternate filling material, such as buckwheat hulls, gel,
water, silicone and the like may be used (not shown). The said
alternate filling material may vary in cross shape and size.
[0076] The device 1 as described herein is designed to elevate a
wound or one or more areas prone to developing a wound, such as the
coccyx 3a, ankle and heel regions 3b, 3c above a surface 9, such as
bedding, so that the surface 9 and the wound or target area is
exposed. As a result of increased air flow and blood circulation,
the wound heals faster and ideally no pressure sores develop. The
ability to tailor the device 1 to suit individual needs allows a
caregiver or the patient to manipulate the shape of the device 1
for optimal use.
[0077] While various embodiments of the present invention have been
described above, it should be understood that they have been
presented by way of example only, and not limitation. It will be
understood by those skilled in the art that various changes in form
and details may be made therein without departing from the spirit
and scope of the invention. Thus, the breadth and scope of the
invention should not be limited by any of the above-described
exemplary embodiments.
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