Title:
Support for prevention of decubitus ulcers
Kind Code:
A1


Abstract:
A garment is disclosed for the prevention of decubitus ulcers. The garment is preferably made of at least two layers which articulate against each other and thus prevent friction against the skin of the wearer. The garment is also padded to prevent excessive pressure against the wearer.



Inventors:
Sheppell, Art (Mountain Lakes, NJ, US)
Application Number:
11/435966
Publication Date:
12/06/2007
Filing Date:
05/17/2006
Assignee:
Art Sheppell (Mountain Lakes, NJ, US)
Primary Class:
International Classes:
A41D13/00
View Patent Images:
Related US Applications:



Primary Examiner:
HOEY, ALISSA L
Attorney, Agent or Firm:
LERNER, DAVID, LITTENBERG, (CRANFORD, NJ, US)
Claims:
1. A garment comprising: (a) a multi-layered material having a first layer proximal to a wearer's skin and a second layer distal to a wearer's skin relative to said first layer; (b) said first layer having at least one edge and engaging said skin in a manner that is substantially immobile; (c) said second layer having at least one edge, said at least one edge contacting said at least one edge of said first layer by selective attachment to least one portion of said edge; whereby said second layer can move in a substantially parallel plane to said first layer and absorb a bed sore inducing shearing force.

2. The garment of claim 1 wherein the first layer further comprises padding.

3. The garment of claim 1 wherein the second layer further comprises padding.

4. A garment adapted to reduce shear forces on a patient comprising: (a) a first layer with a first surface adapted to contact the skin of a patient and a second surface opposing the first surface, said first layer having an outer edge defining a first layer perimeter; (b) a second layer with a first surface in movable communication with said second surface of the said first layer said second layer further comprising a second surface opposite said first surface of said second layer, said second layer having an outer edge defining a second layer perimeter; (c) an attachment modality to selectively attach in at least one region said first layer perimeter to said second layer perimeter whereby the second surface of said first layer articulates over the first surface of said second layer such that said first surface of said first layer is substantially stationary against said patient skin.

5. The garment of claim 4 wherein the first layer comprises padding.

6. The garment of claim 5 wherein the first layer and the second layer are permanently attached.

7. The garment of claim 5 wherein the garment comprises a bandage.

8. The garment of claim 5 wherein the first layer comprises an elastic synthetic fabric.

9. The garment of claim 5 wherein the second layer is nylon.

10. The garment of claim 5 further comprising: (d) a third layer that overlies a portion of the second surface of the second layer.

11. The garment of claim 10 wherein the third layer is removably attached to the second layer.

12. The garment of claim 10 wherein the third layer comprises padding.

13. The garment of claim 10 wherein the third layer comprises canvas.

14. The garment of claim 10 wherein the third layer comprises a handle.

15. The garment of claim 5 wherein the attachment modality is stitching.

16. A garment for preventing decubitus sores on an individual comprising: (a) a first layer of material adapted to contact an individual's skin and create sufficient friction with the skin to inhibit movement of the first layer in a direction parallel to the skin, the first layer comprising: (i) a waist region adapted to surround the waist of a individual, (ii) a pelvic region adapted to surround at least a portion of the pelvis of the individual, (iii) two leg regions adapted to surround at least a portion of the individual's legs, and (b) a second layer of material overlying said first layer of material and joined to said first layer of material at said waist region and said leg regions.

17. The garment of claim 16 further comprising: (c) a third layer of material overlying the second layer of material.

18. The garment of claim 17 wherein the third layer further comprises at least one pocket of padding over at least a portion of the third layer.

19. The garment of claim 18 wherein said at least one pocket of padding comprises two pockets of padding over the iliac regions of the individual.

20. The garment of claim 16 wherein the pelvic region has openings in the genital and anal regions of the individual.

21. The garment of claim 16 wherein the first layer comprises an elastic synthetic material.

22. The garment of claim 16 wherein the second layer comprises nylon.

23. The garment of claim 16 wherein the third layer comprises an absorbent material.

Description:

BACKGROUND OF THE INVENTION

Decubitus ulcers, also known as bed or pressure sores, are injuries of the skin and underlying tissues occurring in person at risk for skin breakdown. These wounds are classified by stages and range in severity from superficial redness, irritation or blistering of the skin to deeper tissue involvement into fat, muscle, tendon, ligament, cartilage and bone. They are caused in most part by prolonged application of pressure and friction to susceptible areas of the body. They occur most often in areas where the soft tissue layer between bone and skin is less ample, such as hips, ankles, heels, elbows, spine and sacral area. Bed sores are common in individuals who spend prolonged periods of time in one position, for example when bedridden, confined to wheelchairs, or when mobility is severely restricted. These sores are generated and accelerated by direct pressure to a susceptible area resulting in reduced and inadequate blood supply which compromises viability of the skin and underlying structures. Mobility and movement protect the healthy individual by relieving pressure periodically even without conscious intent, for example while sleeping. However when immobile for long periods of time, direct pressure may stop the blood supply to an area causing tissue injury, destroying skin integrity resulting in the formation of a wound. Lateral friction or shear forced applied to a susceptible area is an independent factor that promotes the development of bed sores by reducing blood flow through compressed vasculature and by causing skin tears that disrupt the protective cutaneous barrier to infection.

The available treatments for these uncomfortable wounds are for the most part ineffective. Moreover, the few effective treatments are labor intense and very costly. Most treatments address only one aspect of wound genesis and have limited value in practice. An example would be a garment, cushion or mattress using materials like foam, water or air in various applications in an attempt to reduce applied forces by absorbing pressure when interposed between the individual and a surface. This benefit is temporary if the individual is immobile for long periods of time because the material eventually reaches its limit of elasticity resulting in direct pressure to the body part, also known as “bottoming out”. In addition, this approach does not address the shearing force generated with any body movement. In contrast, there is a product that addresses the physical forces of wound genesis, however this bed-like structure is large, cumbersome and very expensive which severely limits its use.

Prevention therefore remains the focus of attention for decubitus ulcers. At the same time, it is desirable to treat existing wounds safely, effectively, comfortably, easily, and economically. The present invention addresses these needs using strategic placement of an energy-absorbing material close or almost adherent to the susceptible body part to reduce and disperse pressure over a larger body surface with greater body mass. It also uses layering of specific materials with different physical properties and coefficients of friction so that when fastened contiguously the device would reduce shearing force. It could also be fashioned to allow the evacuation of the bowels and bladder in order to prevent contamination of wounds.

Thus, there is a need for a device which prevents and treats bed sores by providing adequate padding to the prone areas of an individual and reducing or eliminating shear forces to the skin of an individual.

SUMMARY OF THE INVENTION

In one embodiment, the present invention comprises a garment comprising a multi-layered material having a first layer proximal to a wearer's skin and a second layer distal to a wearer's skin relative to said first layer, wherein the first layer has at least one edge and engaging said skin in a manner that is substantially immobile, the second layer has at least one edge contacting said at least one edge of said first layer by selective attachment to least one portion of said edge, whereby said second layer can move in a substantially parallel plane to said first layer and absorb a bed sore inducing shearing force. The first layer or the second layer may include padding. In some embodiments, both layers include padding.

In another embodiment, the present invention is a garment adapted to reduce shear forces on a patient comprising a first layer with a first surface adapted to contact the skin of a patient and a second surface opposing the first surface, said first layer having an outer edge defining a first layer perimeter, a second layer with a first surface in movable communication with said second surface of the said first layer said second layer further comprising a second surface opposite said first surface of said second layer, said second layer having an outer edge defining a second layer perimeter, and an attachment modality to selectively attach in at least one region said first layer perimeter to said second layer perimeter whereby the second surface of said first layer articulates over the first surface of said second layer such that said first surface of said first layer is substantially stationary against said patient skin. The first layer may comprise padding. The first and second layers may be permanently attached. The garment may comprise a bandage.

In one embodiment, the first layer may comprise an elastic synthetic fabric. The second layer may be nylon.

In one embodiment, the garment may further comprise a third layer that overlies a portion of the second surface of the second layer. The third layer may be removably attached to the second layer. The third layer may comprise padding. The third layer may be made of canvas. The third layer may also include at least one handle.

The layers of the garment may be attached using stitching.

In another embodiment, the invention may comprise a garment for preventing decubitus sores on an individual comprising a first layer of material adapted to contact an individual's skin and create sufficient friction with the skin to inhibit movement of the first layer in a direction parallel to the skin, the first layer comprising a waist region adapted to surround the waist of a individual, a pelvic region adapted to surround at least a portion of the pelvis of the individual, two leg regions adapted to surround at least a portion of the individual's legs, and a second layer of material overlying said first layer of material and joined to said first layer of material at said waist region and said leg regions.

The garment may further include a third layer of material overlying the second layer of material. The third layer may further comprise at least one pocket of padding over at least a portion of the third layer. The at least one pocket of padding may comprise two pockets of padding over the iliac region of the individual.

The garment may have openings in the genital and anal regions of the individual.

The first layer of the garment may comprise and elastic synthetic material. The second layer may comprise nylon. The third layer may comprise an absorbent material.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a rear view of a garment according to the preset invention.

FIG. 1A is a front view of the garment depicted in FIG. 1.

FIG. 2 is a cross-section view of a garment according to the present invention.

FIG. 2A is a cross-section view of a garment according to the present invention.

FIG. 2B is a cross-section view of a garment according to the present invention.

FIG. 3 is a side view of an alternate embodiment of a garment according the present invention.

FIG. 4 is a side view of yet another alternative embodiment of a garment according the present invention.

DETAILED DESCRIPTION

The present invention is a device for the prevention of decubitus ulcers comprising at least two layers of fabric or material. The invention may be in the form of a garment to be worn over a part of a patient's body. The invention may be a garment or adapted to cover or wrap around any portion of a patient's body, such as the head, shoulders, elbows, buttocks, lower legs, ankles, or heels. For convenience, we refer to any apparel, wrap, cover, or bandage embodying the invention as a garment. The garment may be a bandage affixed to a patient's body, or a bandage or material that is wrapped around a portion of a patient's body. The garment is comprised of two or more layers. The layers may be separately applied in a multi-step manner to generate the structure or, preferably, the two or more layers are permanently or selectively affixed to each other by any of many known methodologies including hook and loop fasteners, zippers, or sewing.

Presently, the preferable embodiment of the invention is a garment. Such garment would be worn in a manner akin to ordinary apparel either as a supplement to such apparel or in lieu of such ordinary apparel. Regardless, the relative position of the layers of the inventive structure must be incorporated into the garment, bandage, material or device encompassing the present invention. Thus, in the context of a garment or other structure consistent with this invention, one layer is preferably disposed against the skin of a patient suffering from or in danger of suffering from decubitus ulcers. This skin-contacting layer is adapted to grip the skin, adhere to the skin, or simply rest against or otherwise contact the skin in such a way as to prevent or significantly minimize movement of the layer vertically or horizontally over the skin when a shear force is exerted laterally against the structure. The inventive structure also has at least a second layer, preferably affixed to the first layer. Such second layer may be affixed as described herein. In a preferred embodiment, the second and first layers are engaged only in selected portions, such as in spaced intervals or only at the outer periphery or edges. Regardless of how affixed, the layers should move or articulate in reference to each other unhindered or with a resistance that is of a low enough value to largely permit independent movement of the two layers. The resistance value allows for the energy of a bed sore inducing force to be absorbed by the low resistance movement of the two layers vis a vis each other thus preventing the shear force from exerting energy across a patient's skin in a manner that can cause bed sores. For example, when a lateral force, or shearing force, is applied to a patient's skin when the patient is bedridden, the shearing force against the patient's skin will be absorbed by the inventive structure when a layer distal to the patient's skin articulates over a second layer proximal to a patient's skin without causing the structure to move laterally across a patient's skin in a decubitus ulcer inducing movement. The second layer may be a material or fabric that stretches to allow for further articulation over the first layer.

One skilled in the art would recognize that various intermediate layers may be added without departing from the crux of the invention. For example, in one embodiment of a device according to the present invention, a first layer may be disposed against the skin of an individual and a second layer may be adhered to the first layer. Then a third layer may be disposed over the second layer and affixed in a way as to allow portions of the third layer to articulate over the second layer. In this embodiment, shear forces against a patient's skin will still be prevented by the articulation of the third layer over the second layer of the device. The intermediate second layer may be useful when the first layer is made of a material adapted to prevent excessive sliding over the skin, but that material does not allow for easy articulation of another layer of material on its opposite side. Such intermediary layers may be of a wide range of materials so long as the low resistance movement of the layers of this invention are achieved.

Various embodiments of the invention will now be described with reference the figures. FIG. 1 depicts a rear view of a plurality of layers of fabric of the present inventive structure fashioned into a garment according to the present invention for surrounding the hips of an individual for the prevention of decubitus ulcers. Although this type of structure is depicted for exemplary purposes, the garment could be fashioned for any of the uses herein such as a sock-like device for preventing or minimizing bed sores in the ankle region. The inventive structure formed into a garment is especially useful for individuals such as immobilized or wheelchair bound patients, especially those in a hospital or nursing home. The structure depicted in FIG. 1 has various layers that are joined only at the outer edge. For the depicted embodiment such jointure is made with sewn seams 30. Alternatively, the garment may have more than one layer joined at measured intervals, such as stitched seams every six inches. Although stitched seams may be preferred in a garment embodiment, the layers may be joined together with other fastening methods known in the art that permit the requisite movement of the layers to ameliorate or negate patient skin shear force that induces bed sores. The garment may also have additional bed sore resistant structures to enhance the bed sore fighting malleability of the present invention. As shown in FIG. 1, such additional structure may be padding 20 located at preferably locations for padding, such as locations were the patient is more susceptible to bed sores. These locations include areas where the skin is close to bone, such as behind the ilium on the pelvis of the patient. Other optional structures may be included in a garment embodying the inventive structure that are particular to the body area in which the garment is worn. In the depicted instance, the garment preferably has an open or openable area 40 around the area of a patient that functions to evacuate waste such as from the rectum or urinary tract without removal of the garment. Other garment openings can be used to apply medicament to a needed area or to permit access to a bodily area in need of medical treatment.

The garment depicted in FIG. 1 has a waist region 12 adapted to surround the waist of a wearer. The garment also has a pelvic region 14 which is shaped to surround the pelvis of a user. The garment further includes two leg regions 16 which surround at least a portion of the legs of a user. In this embodiment, the garment is made up of layers which are joined to each other only at the waist region 12 and at the edge of the leg regions 16 as depicted in FIG. 1.

A front view of this garment is depicted in FIG. 1A. The garment preferably has a large opening 40 on the front of the garment for the genitals of the wearer so that the wearer may urinate without removing the garment. The opening also provides ventilation to areas of the patient's body which need not be protected against bed sores.

A cross-section of a structure for preventing bed sores according to the present invention is depicted in FIG. 2. The garment is preferably made of at least three layers, but may contain only two layers in some embodiments. A first layer 100 is adapted to fit against or contact a patient's skin 90 in such a way as to engage or touch at least some portion of the patient's skin 90 without movement along the skin in a bed sore inducing manner. Layer 100 must contact the skin 90 in a substantially stationary single location where it is desirably engaged or in such a way as to develop a minimally sufficient level of friction that inhibits the movement of the layer against the skin. The substantially stationary engagement with the skin allows for other areas of the structure such as the second layer 200 and third layer 300 to move relative to the first layer 100 and absorb shear force without generating substantial movement on the skin contacting portion of the depicted structure. The first layer 100 is shown as attached to the second layer 200 by stitching 95 located only in the edge region 100 of the garment 10. The second layer 200 and the third layer 300 are depicted as attached by stitching 95 in multiple locations because they are not adapted to articulate over each other in this embodiment.

One suitable material which may be used for the first layer 100 is an expandable elastic material such as spandex or LYCRA™, manufactured by Invista. This material will stretch over the skin and create sufficient friction with the skin of a patient to prevent the material from moving laterally over the skin of the patient. This material will also serve to wick moisture away from the skin in order to prevent the sliding of the first layer over the skin. One skilled in the art would recognize that any material may be used for the first layer that wicks or absorb moisture away from the skin and does not easily slide over the skin.

Other materials that may be used for the first layer include rayon; Aquaflo™, manufactured by H. Warshow & Sons FieldSensor™, manufactured by Toray Industries; Pertex™, manufactured by Bask Canada, Inc.; Microlight™, manufactured by Perseverance Mills Ltd.; Polartec™ Power Stretch™ and Polartec™ Aqua Shell™, manufactured by Malden Mills, Inc.; Procore™ and Drylete™, manufactured by Hind USA; Supplex™, Cordura™, and Tactel™, manufactured by Invista; Ultrex™ and Xalt™, manufactured by Burlington Indus.; Biofresh™, manufactured by Sterling Fibers, Comfortrel™ and Comfortrel™ Plus, manufactured by Wellman, Inc.; Dryline™, manufactured by Millikin & Co and Drilite™ Extreme, manufactured by Mountain Equipment.

Other materials that are suitable for user in either the second layer or the optional third layer include cotton; wool; Cordura™, manufactured by Invista; Amara™, manufactured by Kuraray Co., Ltd.; Durapel™, manufactured by Burlington Indus.; Duraspun™, manufactured by Solutia Inc., eVent™ fabric, manufactured by BHA Technologies, Inc.; Hydroflex™, manufactured by Consoltex, Inc.; and Hydroweave™, manufactured by Aquatex Indus., Inc.

The outer layer may be coated with one of the following materials: Nikwax™, manufactured by Nikwax North America, Inc.; ScotchGard™, manufactured by 3M, Gore-Tex™, manufactured by W.L. Gore & Assoc.; PolarFleece™, manufactured by Malden Mills, Inc.; Capilene™, manufactured by Patagonia, Inc.; Thinsulate™, manufactured by 3M; and Triplepoint™ Ceramic manufactured by Lowe Alpine.

The second layer of the garment 200 is preferably only joined to the first layer 100 in the edge region 110, or seams, of the garment as also depicted in FIGS. 1 and 1A. But any joining will suffice that allows the second layer 200 to articulate or move with little resistance over the first layer 100. The movement which may be in a plurality of directions is exemplified by the vector force arrows 115 associated with movement of the relative articulating layers 200 and 300. As illustrated by the arrows 115, the second layer 200 moves over the first layer 100 in either direction that is approximately parallel to the skin 90, not perpendicular to the skin 90. Preferably, the movement is such that downward pressure on the skin is mitigated to avoid exacerbatory rubbing or increasing the risk of bed sores to a patient in discomfort. The arrows 115 in FIG. 2 show that the second layer 200 and thus the third layer 300 attached to the second layer may move in two different directions simultaneously over the first layer 100 such that the second layer 200 may bunch up or fold over itself to prevent shear force from transferring to the skin. Another possible movement of the second layer 200 is depicted in FIG. 2A wherein the entire second layer 200 moves in the same direction—laterally over the first layer 100—while the first layer 100 remains substantially stationary. Thus, the second layer must be made from a material that can easily move over the material used for the first layer. If one embodiment, the second layer may be made of nylon or polyester if the first layer is spandex because nylon or polyester easily articulates over spandex.

The optional third layer 300 of the garment is preferably made of a durable material such as canvas. The function of an exemplary third layer is to provide padding to the patient and to protect the garment. Certain areas of the garment may have pockets 400 of extra padding in order to relieve the pressure on areas of the patient that are prone to bed sores. The pockets 400 may be filled with a padding such as temperpedic padding as known in the art. The pockets 400 are preferably covered with a fourth layer 500 which may be the same material as the third layer 300. An alternate embodiment of the pocket 400 may be filled with a gel or beads for providing padding as known in the art. In other embodiments, the third layer 300 may comprise a changeable padding used to provide comfort to the patient, an absorbent material used to wick away sweat or other fluids, or another material designed to be visually appealing in order to make the patient more comfortable with their appearance. The third layer may also have one or more handles attached thereto on the side of the third layer opposite the skin of the patient. The handles may assist health care personnel in moving patients who have diminished mobility.

In alternative embodiments, the pocket 400 depicted in FIG. 2 containing extra padding may be integrated into either the first layer 100 or the second layer 200. In some embodiments, it is preferable to locate the pockets of padding against the skin in the first layer 100 so that they do not articulate over the patient, causing them to move away from an area that needs the padding. Incorporating the padding into the first layer may also prevent discomfort for the patient because the padded area will move with the patient while the second and possibly third layer will articulate over the padding. A cross-section of one embodiment of a garment 10 according to the present invention with padding located in the first layer is depicted in FIG. 2B. The first layer 100 is adapted to contact the skin 90 of a patient. The first layer 100 preferably contains at least one pocket 400 which may be filled with air or padding as discussed above. The second layer 200 is attached to the first layer 100 using stitching 95 at only the edge of the garment 10. The stitching 95 at the edge of the garment 10 may actually join all three layers. The rest of the garment 10 preferably has stitching 95 that joins the second layer 200 and the third layer 300 but allows the second layer 200 and third layer 300 to move freely over the first layer 100. Because the first layer 100 is stationary against the skin 90 of a patient, the padding contained in the pocket 400 of the first layer 100 remains stationary relative to the patient when the patient moves.

The second layer 200 and the third layer 300 articulate, or move with little resistance, over the first layer 100 as depicted by the vector force arrows 115. As illustrated by the arrows 115, the second layer 200 and the third layer 300 move over the first layer 100 in either direction that is approximately parallel to the skin 90, not perpendicular to the skin 90.

FIG. 3 depicts an alternate embodiment of a garment for preventing bed sores according the present invention. The garment depicted in FIG. 3 is an ankle and heel protection garment. The garment 50 is adapted to surround the ankle and heel of the wearer. The garment 50 preferably has two padded areas 54 covering the heel and the ankle bone which are susceptible to bed sores. The seams 52 of the garment, showing how the layers are joined at the edge of the garment using stitching or another means known in the art such as adhesive, are also depicted in FIG. 3.

An elbow protection garment is depicted in FIG. 4. The garment 60 preferably covers the elbow region of a wearer and has a padded area 64 covering the elbow of a wearer to prevent bed sores to the elbow. The seams 62 of the elbow garment 60, which is where the layers are joined, are also depicted in FIG. 4.

The depicted structures prevent shear against a individual's skin by allowing the layers of the garment itself to articulate against each other whilst the skin contacting layer is substantially stationary against the skin so as to avoid shearing forces that induce bed sores. For example, if a patient in a nursing home is wearing the garment depicted in FIG. 1 for protection of the patient's hips, the pockets of the padding 20 will distribute the weight of the patient so that bed sores will not form near the hip bone of the patient. While the patient is wearing the garment, if the patient moves or shifts in his or her bed the patient's skin will not rub against the bed because of the garment. The patient's skin will also not rub against the garment because the first layer 100 of the garment will preferably be stretched across the patient's skin in such a way as to grip the patient's skin. When the patient moves the shear forces will be absorbed by the garment in that the first layer 100 will move over the second layer 200 of the garment. Because these two layers of the garment are made of materials that provide for easy articulation against each other, the shearing forces are easily absorbed by the garment. Thus, the garment prevents shearing forces and excessive pressure against body of a patient and thus prevents the patient from contracting bed sores.

The various garments described and depicted in the Figures may be made partially or entirely of elastic materials so that the garments may simply be pulled on and off of the patient. In other embodiments, the garments may be opened in certain areas and affixed to the patient with fasteners such as tape or a hook and loop fabric such as Velcro brand. Various different embodiments for attaching the garments to individuals will be apparent to those skilled in the art of medical and protective garments.

Because the garments are preferably made of well-known materials such as spandex and nylon, the garments can be manufactured in different sizes for little cost. This will enable healthcare facilities to purchase the garments for all of their patients who are at risk for bed sores, thus preventing the painful and dangerous affliction. The low cost will also enable individuals to purchase the garments for home use.

The low cost of the garments also means that the invention may be used in conjunction with disposable garments, such as disposable absorbent undergarments commonly used by incontinent individuals. Portions of the undergarments may use the layers described above to prevent pressure and shear forces against an individual who is wearing the undergarment.

In an alternate embodiment of the invention, the garment comprises only a single layer which is made of a material that articulates with minimal resistance over the skin while providing insufficient friction to the skin to irritate the skin. This garment may have elastic bands at the edges of the garment to hold the garment to the patient while allowing the rest of the garment to move freely over the skin of the patient.

Although the invention herein has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present invention. It is therefore to be understood that numerous modifications may be made to the illustrative embodiments and that other arrangements may be devised without departing from the spirit and scope of the present invention as defined by the appended claims.





 
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