US20070163048A1

US20070163048A1 - Method and device for pressure offloading

Info

Publication number: US20070163048A1
Application number: US11/716,469
Authority: US
Inventors: Helen Kimball
Original assignee: Individual
Current assignee: Individual
Priority date: 2005-09-19
Filing date: 2007-03-09
Publication date: 2007-07-19
Also published as: WO2008112172A1

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.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

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

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

Chronic wounds are a great burden to healthcare and account for billions of dollars in healthcare costs annually.
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.
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.
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.
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.
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.
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.
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^thleading cause of death, overall.
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.
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.
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.
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.
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.
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.
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.
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.
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.
These cushioning means, however, are large and bulky and cannot be easily manipulated to alter their shape or size to accommodate individual needs.
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.
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.
Similarly, the “Waffle Extended Care Cushion” from EHOB, Inc., although compact, cannot be manipulated with ease to adopt a different shape or size.
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.
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.
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.
The present invention accomplishes these objectives and substantially departs from the conventional concepts and designs of the prior art.

SUMMARY OF THE INVENTION

The present invention solves the foregoing problems by providing a method and device for the treatment and prevention of wounds.
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.
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.
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.
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.
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.
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.
An object of the present invention is to keep critical pressure points above a surface, such as bedding.
An advantage of the disclosed invention is that it is proactive in the prevention of pressure ulcers and not merely reactive.
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.
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.
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
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.
Another object of the present invention is to diminish pressure from surface wounds with a device that is light weight and easy to handle.
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.
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.
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

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;
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;
FIG. 2A is a cross-sectional view of the invention, taken generally along lines 2A-2A of FIG. 1A;
FIG. 2B is a cross-sectional view of the invention, taken generally along lines 2B-2B of FIG. 1B;
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;
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;
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;
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;
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;
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;
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;
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;
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
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

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.
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.
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.
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.
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.
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.
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.
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.
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.
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 16 a, bottom 16 b, and middle 16 c layer. The top 16 a and bottom 16 b layers are preferably comprised of foam 16, and the middle layer 16 c is preferably comprised of polyethylene, polyurethane or other suitable material and provides a flexible inner support.
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 3 b and a ball 3 f 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 14 a for the ball 3 f of the foot and a second hollow region 14 b for the heel 3 b 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 3 f of the foot being over the first hollow region 14 a, and the heel 3 b of the foot being held over the second hollow region 14 b, such that the ball 3 f and heel 3 b 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 3 f and the heel 3 b of the foot.
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.
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 3 b and heel 3 c regions, above the surface 9.
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 3 a, heels 3 b, ankles 3 c, a hip 3 d or an ear 3 e.
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.
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.
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.
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 3 a, ankle and heel regions 3 b, 3 c 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.
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.

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:

(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;

(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.