WO2017039668A1 - Pressure ulcer prevention device - Google Patents

Abstract

A pressure ulcer prevention article and a method involving the pressure ulcer prevention article are disclosed. The pressure ulcer prevention article includes a substrate, a bonding layer, a cushioning layer, and a skin adhesive layer. The substrate may be a polypropylene bonded carded material and the cushioning layer may be an open-celled foam. The outer substrate surface can include a dynamic coefficient of friction ranging from about 0.1 to about 0.6. The pressure ulcer prevention article can include a moisture vapor transmission rate ranging from about 2,400 gm/m^2*day to about 10,000 gm/m^2*day. The pressure ulcer prevention article can include a compression energy value from about 2 g_fcm/cm2 to about 5 g_fcm/cm².

Description

PRESSURE ULCER PREVENTION DEVICE

TECHNICAL FIELD

Pressure ulcer prevention articles and a method of use are described.

BACKGROUND OF THE DISCLOSURE The present disclosure involves pressure ulcer prevention articles and their use with the human body. Pressure ulcers may be referred to as bedsores, decubitus ulcers, or pressure sores and are of great interest in healthcare as pressure ulcers can be life-threatening and can compromise a person's ability to ward off and/or heal from other infections. Pressure ulcers can result from the combination of healthy or unhealthy skin, or underlying muscle or tissue, combined with pressure, friction, and/or compression and shear forces on pressure-prone and shear-prone areas of the human body. Pressure-prone and shear-prone areas of the body can include any area of the body that has a bony prominence including, but not limited to such areas as the tailbone or sacrum, lower back, hips, shoulder blades, elbows, ankles, knees, back of the head, ears, and feet.

Pressure ulcers commonly occur with people who have little to no mobility and may spend time being sedentary, for example, sitting in a wheelchair, lying in bed, or during a surgical procedure. In these situations, the pressure-prone and shear-prone areas of the body can be subjected to compression forces, or pressure, for long periods of time if the person is unable to change their sitting or lying position. Over time, pressure can cause diminished blood flow to the pressure-prone and shear-prone areas. A lack of oxygen due to diminished blood flow can lead to damage of the skin, tissue, and/or muscle in the pressure-prone, shear-prone and surrounding areas. Skin cells can also be damaged due to the mechanical stresses that the cells are exposed to. Since many people in these situations are dependent on others to help them change the position of their body, the formation of pressure ulcers or the presence of them can be exacerbated if the body position is not changed on a frequency that is specific to that person's weight and existing skin health. Additionally, the pressure-prone and shear-prone areas can experience friction and shear forces when the skin and the underlying bone move in opposite directions or in the same direction at differing rates. For example, pressure-prone and shear-prone areas of a bedridden person may experience friction and shear forces if the body is slid against the bed while being moved from one position to the next, as opposed to being lifted away from the bed and being repositioned prior to being laid back down. Other examples can include when a person is moved during surgery or moved while on or to or from a backboard. Skin moisture and overall health conditions are other variables involved with pressure ulcers. Excessive moisture, within or on the skin, can break down the skin and may be present from sweat, urine, feces, or exudates from wounds. Excessive dryness can cause skin to crack open or become broken, which can make the skin more susceptible to infection and inflammation. Overall health conditions affecting skin health can include, although are not limited to diabetes, high blood pressure and aging in general. Diabetes and blood pressure affect blood circulation and the normal aging process is also known to increase the fragility of the skin.

There are currently several approaches to preventing or treating pressure ulcers that range in cost. Low cost approaches include skin cleansers and lotions that are intended to prevent pressure ulcers by keeping skin moisturized and clean as a means to avoid infection. Approaches increasing in cost include cushions that the person may sit or lie on that are intended as prevention means, or dressings that adhere to the body in pressure-prone and shear-prone areas and are intended as prevention or treatment means. A higher cost prevention and treatment approach includes utilizing health care workers to help move a person into different positions. A higher cost treatment approach includes devices that provide negative pressure wound therapy (NPWT). To put these costs into perspective, for the United States alone, pressure ulcer care has an estimated cost of between $500 (USD) and $70,000 (USD) per individual pressure ulcer (Prevention and Treatment of Pressure Ulcers: Clinical Practice Guideline. Emily Haesler (Ed.) Cambridge Media; Osborne Park, Western Australia; 2014.). While several of these options address some of the factors involved with the prevention or perseverance of pressure ulcers, there remains a need for a low cost pressure ulcer prevention and treatment option that addresses the control of moisture, pressure, shear, and frictional forces.

SUMMARY OF THE DISCLOSURE

In one aspect, the disclosure includes a pressure ulcer prevention article. The pressure ulcer prevention article includes a substrate. The substrate has an inner substrate surface and an opposite outer substrate surface. The inner substrate surface includes a substrate area. The opposite outer substrate surface has a dynamic coefficient of friction ranging from 0.1 to 0.6. The pressure ulcer prevention article includes a bonding layer disposed on the inner substrate surface. The pressure ulcer prevention article includes a cushioning layer having a body facing surface, a cushioning layer area and an opposite substrate facing surface. A skin adhesive layer is disposed on the body facing surface. The cushioning layer is disposed between the bonding layer and the skin adhesive layer. The pressure ulcer prevention article includes a moisture vapor transmission rate ranging from 2,400 gm/m²*day to 10,000 gm/m²*day.

In another aspect, a method of preventing pressure ulcers on unbroken skin is disclosed. The method includes the steps of cleansing the unbroken skin with a mild soap and water, drying the unbroken skin with a cloth or paper towel, and providing a pressure ulcer prevention article. The pressure ulcer prevention article includes a substrate that has an inner substrate surface and an opposite outer substrate surface. The inner substrate surface includes a substrate area. The opposite outer substrate surface has a dynamic coefficient of friction ranging from 0.1 to 0.6. The pressure ulcer prevention article includes a bonding layer disposed on the inner substrate surface. The pressure ulcer prevention article includes a cushioning layer with a body facing surface, cushioning layer area and an opposite substrate facing surface. A skin adhesive layer is disposed on the body facing surface. The cushioning layer is disposed between the bonding layer and the skin adhesive layer. The pressure ulcer prevention article has a moisture vapor transmission rate ranging from 2,400 gm/m²*day to 10,000 gm/m²*day. The last step of the method includes disposing the pressure ulcer prevention article to the unbroken skin by adhering the skin adhesive layer to the skin.

In a further aspect, a pressure ulcer prevention article includes a substrate with an inner substrate surface and an opposite outer substrate surface. The inner substrate surface includes a substrate area. The substrate is a polypropylene bonded carded material. The opposite outer substrate surface has a dynamic coefficient of friction ranging from 0.1 to 0.6. The pressure ulcer prevention article includes a bonding layer disposed on the inner substrate surface and the bonding layer covers between 60% and 95% of the substrate area. The pressure ulcer prevention article includes a cushioning layer with a body facing surface, a cushioning layer area and an opposite substrate facing surface. The cushioning layer is a foam that has a compression energy value ranging from 2 gfcm/cm² to 5 gfcm/cm². The pressure ulcer prevention article includes a skin adhesive layer disposed on the body facing surface and the skin adhesive layer covers between 60% and 95% of the cushioning layer area. The cushioning layer is disposed between the bonding layer and the skin adhesive layer. The pressure ulcer prevention article has a moisture vapor transmission rate ranging from 2,400 gm/m²*day to 10,000 gm/m²*day.

In an additional aspect, a pressure ulcer prevention article includes a substrate with an inner substrate surface and an opposite outer substrate surface. The inner substrate surface includes a substrate area. The substrate is a polypropylene bonded carded material. The pressure ulcer prevention article includes a bonding layer disposed on the inner substrate surface. The pressure ulcer prevention article includes a cushioning layer with a body facing surface, a cushioning layer area and an opposite substrate facing surface. The cushioning layer is a foam. The pressure ulcer prevention article includes a skin adhesive layer disposed on the body facing surface.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1 representatively illustrates a pressure ulcer prevention article. FIG. 2A representatively illustrates a bonding layer on an inner substrate surface of the pressure ulcer prevention article of FIG. 1 .

FIG. 2B representatively illustrates a cross section of the bonding layer and the substrate taken at line 2B-2B of FIG. 2A.

FIG. 3A representatively illustrates a skin adhesive layer on a body facing surface of a cushioning layer of the pressure ulcer prevention article of FIG. 1 .

FIG. 3B representatively illustrates a cross section of the skin adhesive layer and the cushioning layer taken at line 3B-3B of FIG. 3A.

FIG. 4A representatively illustrates another aspect of a pressure ulcer prevention article.

FIG. 4B representatively illustrates a perspective view of the pressure ulcer prevention article shown in FIG. 4A.

FIG. 5 representatively illustrates moisture vapor transmission rates for the disclosed pressure ulcer prevention article and commercial products.

FIG. 6 representatively illustrates coefficient of friction values for the disclosed pressure ulcer prevention article and commercial products. FIG. 7 representatively illustrates coefficient of friction values and moisture vapor transmission rates for the disclosed pressure ulcer prevention article and commercial products.

Repeat use of reference characters in the present specification and drawings is intended to represent the same or analogous features or elements of the disclosure.

DETAILED DESCRIPTION OF THE DISLOSURE The term "breathable" or "breathability" refers herein to the moisture vapor transmission rate

(MVTR). MVTR generally refers to the rate at which water vapor permeates through a material as measured in units of grams of water per meter squared per 24 hours (g/m²/24 hrs), with higher values representing a more breathable material and lower values representing a less breathable material. The terms further refer to the material being pervious to water vapor and gases, but impermeable to liquid water. For example, a breathable substrate that is placed over human skin can let water vapor and gases permeate from the surface of the skin through the substrate from the body side of the substrate while liquid that is on the outer side of the substrate (surface of the substrate that is away from the skin) is not able to permeate through the substrate to the skin.

The term "carded web" refers herein to a web containing natural or synthetic staple length fibers typically having fiber lengths less than about 100 mm. Bales of staple fibers can undergo an opening process to separate the fibers which are then sent to a carding process which separates and combs the fibers to align them in the machine direction after which the fibers are deposited onto a moving wire for further processing. The web is usually subjected to some type of bonding process such as thermal bonding using heat and/or pressure, ultrasonic bonding, or may be subject to adhesive processes to bind the fibers together. The carded web may be subjected to fluid entangling, such as hydroentangling, to further intertwine the fibers and thereby improve the integrity of the carded web.

The term "coform" refers herein to a blend of meltblown fibers and absorbent fibers such as cellulosic fibers that can be formed by air forming a meltblown polymer material while simultaneously blowing air-suspended fibers into the stream of meltblown fibers. The meltblown fibers and absorbent fibers are collected on a forming surface, such as provided by a belt. Two U.S. patents describing coform materials are U.S. Patent No. 5,100,324 to Anderson et al. and U.S. Patent No. 5,350,624 to Georger et al., both of which are incorporated in their entirety in a manner consistent herewith.

The term "compression" refers herein to aligned forces pushing a first object in one direction and a second object in the opposite direction against the first object; for example such that the first object and the second object are being pushed against each other. The term "film" refers herein to a thermoplastic film made using an extrusion and/or forming process, such as a cast film or blown film extrusion process. The term includes apertured films, slit films, and other porous films which constitute liquid transfer films, as well as films which do not transfer fluids, such as, but not limited to, barrier films, filled films, breathable films, and oriented films. The term may even include liquid absorbent films. The term "meltblown" refers herein to fibers formed by extruding a molten, thermoplastic material through a plurality of fine, usually circular, die capillaries as molten threads or filaments into converging high velocity gas (e.g., air) streams, generally heated, which attenuate the filaments of molten thermoplastic material to reduce their diameters. Thereafter, the meltblown fibers are carried by the high velocity gas stream and are deposited on a collecting surface or support to form a web of randomly dispersed meltblown fibers. Such a process is disclosed, for example in U.S. Patent No. 3,849,241 to Butin et al. which is incorporated herein by reference in its entirety in a manner consistent herewith.

The terms "nonwoven" and "nonwoven web" refer herein to materials and webs of material that are formed without the aid of a textile weaving or knitting process. For example, nonwoven materials, fabrics or webs have been formed from many processes such as, for example, meltblowing processes, spunbonding processes, air laying processes, coform processes, and bonded carded web processes, and can include webs formed of combinations thereof.

The term "shear" refers herein to unaligned forces pushing a first object in one direction and a second object in the opposite direction against the first object; for example such that the first object and the second object are being slid against each other.

The term "spunbonded fibers" refers herein to small diameter fibers which are formed by extruding molten thermoplastic material as filaments from a plurality of fine, usually circular-capillaries of a spinneret with the diameter of the extruded filaments then being rapidly reduced to fibers as by, for example, in U.S. Patent No. 4,340,563 to Appel et al.; U.S. Patent No. 3,692,618 to Dorschner et al.;

U.S. Patent No. 3,802,817 to Matsuki et al.; U.S. Patent Nos. 3,338,992 and 3,341 ,394 to Kinney; U.S.

Patent No. 3,502,763 to Hartman; and U.S. Patent No. 3,542,615 to Dobo et al., the contents of which are incorporated herein by reference in their entirety in a manner consistent herewith.

The term "thermoplastic" refers herein to a material which softens and which can be shaped when exposed to heat and which substantially returns to a non-softened condition when cooled.

The present disclosure relates to a pressure ulcer prevention article 10 that controls skin moisture and mitigates pressure, friction, and shear forces on pressure-prone and shear-prone areas of the body as well as on existing pressure ulcers. For example, when a non-breathable covering is placed over a pressure-prone or shear-prone area, a micro-climate of the skin is created such that heat and moisture may by trapped near the skin thus exacerbating conditions for a pressure ulcer to form. It is essential that the pressure ulcer prevention article 10 is breathable to allow excessive moisture to move away from the skin. The pressure ulcer prevention article 10 should have low friction on the outer surface to reduce shear forces when the pressure-prone or shear-prone area is moved against a surface such as for example, clothing, furniture, the seat of a wheelchair, or a bed sheet. Additionally, the pressure ulcer prevention article 10 reduces pressure by dissipating and absorbing shear and compression forces by cushioning the pressure-prone or shear-prone areas.

Referring to FIG. 1 , the pressure ulcer prevention article 10 includes a substrate 12, a bonding layer 18, a cushioning layer 22, and a skin adhesive layer 28. The substrate 12 includes an inner substrate surface 14 and an opposite outer substrate surface 16. The cushioning layer 22 includes a body facing surface 24 and an opposite substrate facing surface 26. The bonding layer 18 is disposed between the inner substrate surface 14 of the substrate 12 and the substrate facing surface 26 of the cushioning layer 22 such that the substrate 12 and the cushioning layer 22 are attached to the bonding layer 18. The skin adhesive layer 28 is disposed on the body facing surface 24 of the cushioning layer 22. The skin adhesive layer 28 may be protected with a release paper or peel strip (not shown) as is known in the art.

Some of the individual components of the pressure ulcer prevention article 10 may address the pressure, shear, or friction factors of pressure ulcer formation while collectively, all components can operatively permit a sufficient passage of air and moisture vapor out of the pressure ulcer prevention article 10 to address the skin moisture control aspect. For example, the substrate 12 is intended to dissipate shear forces upon the skin and thus should have low friction. Additionally, the substrate 12 is breathable. Suitable materials for the substrate 12 can include woven or nonwoven materials. For example, suitable woven materials may be surface treated to have low friction.

Nonwoven materials may include, but are not limited to, films, papers or fibrous nonwovens. Films may include porous films, perforated films and apertured films. Papers may include coated or uncoated papers that have been perforated and smooth calendared. Fibrous nonwoven materials may include spunbonds or other fibrous nonwovens that are treated with friction reducing chemicals and/or that are flat or smooth roll calendared, or spunlaces having an open pattern that are also smooth calendared. An exemplary fibrous nonwoven material is a polypropylene bonded carded material available from Sandler AG, Salle, Germany, under the trade name of SAWABOND. This SAWABOND polypropylene bonded carded material is smooth roll calendared providing a smooth surface with low friction. The SAWABOND polypropylene bonded carded web can range in basis weight from about 10 grams/meter squared (gsm) to about 50 gsm and more specifically from about 15 gsm to about 30 gsm. Fiber types other than polypropylene, such as bicomponent fibers of polyethylene/polyethylene terephthalate, may also be suitable.

The cushioning layer 22 is intended to dissipate and absorb compressive and shear forces. Additionally, the cushioning layer is breathable and may also be hydrophobic. The breathable and hydrophobic properties of the cushioning layer 22 contribute towards controlling the micro-climate of the skin by allowing moisture to move away from the skin while not holding moisture near the skin. Suitable materials for the cushioning layer 22 can include, although may not be limited to a variety of nonwoven materials such as fibrous nonwovens or foam. A suitable fibrous, nonwoven material may be a corrugated material that remains flexible and soft while resisting compressive forces and is described in U.S. Published Application No. 2003/0022584 to Latimer et al., which is incorporated by reference in a manner that is consistent herewith. Foams can be open or closed cell foams. A suitable foam may be hydrophobic and have a thickness of less than about 10 mm, and more specifically from about 2 mm to 5 mm. An exemplary open-celled, polyester foam is 100 PPI Natural Regicell and is available from Woodbridge FoamPartner Company, Chattanooga, TN, USA. The substrate 12 and the cushioning layer 22 can be attached to one another using means known in the art such as adhesive, heat and/or pressure bonding, ultrasonic bonding and other suitable attachments. Referring to FIG. 1 , in one aspect, the substrate 12 and the cushioning layer 22 are attached to one another with a construction adhesive that is the bonding layer 18. Commercially available construction adhesives usable as the bonding layer 18 include but are not limited to, for example, Rextac adhesives available from Huntsman Polymers of Houston, TX, USA, and adhesives available from Bostik Findley, Inc., of Wauwatosa, Wl, USA, such as H2525A.

The skin adhesive layer 28 is applied to the cushioning layer 22 to allow for the pressure ulcer prevention article 10 to be adhered to the skin of the pressure-prone area. Generally, any pressure sensitive adhesive known to those skilled in the art may be used as the skin adhesive layer 28, although preferably the pressure sensitive adhesive is not a known irritant to human skin and preferably the adhesive is not so aggressive that it causes pain to the wearer when the pressure ulcer prevention article 10 is removed from the skin and/or hair. It is also desirable that the skin adhesive layer 28 is selected such that the adhesive does not leave a substantial amount of an adhesive residue on the surface of the skin of the wearer when the pressure ulcer prevention article 10 is removed from the wearer after use. Particularly suitable pressure sensitive adhesive materials are disclosed in commonly assigned U.S. Pat. No. 6,213,993 to Zacharias et al. and U.S. Pat. No. 6,620,143 to Zacharias et al., which are incorporated herein by reference in a manner that is consistent herewith. Other suitable adhesives are disclosed in U.S. Pat. No. 5,618,281 to Batrabet et al., which is incorporated herein by reference in a manner that is consistent herewith. Other known body adhesives, such as those described in U.S. Pat. No. 6,316,524 to Corzani et al., which is incorporated by reference in a manner that is consistent herewith, may also be used. Additional examples of suitable pressure sensitive adhesives include hydrogels, hydrocolloids, acrylic based adhesives, rubber based adhesives, such as KRATON based adhesives (KRATON available from Kraton Performance Polymers Inc., Houston, TX, USA), and acrylic based adhesives available from

DermaMed Coatings Co., LLC, Tallmadge, OH, USA.

In some aspects, the optional release sheet is not desirable. For example, the pressure ulcer prevention article 10 may be rolled, folded onto itself, or stacked upon adjacent pressure ulcer prevention articles 10. If rolled, the skin adhesive layer 28 will generally contact the outer substrate surface 16 of the substrate 12. The skin adhesive layer 28 should readily release from the outer substrate surface 16 when unrolled by the user. In addition, it is desirable that the skin adhesive layer 28 does not leave a residue on the outer substrate surface 16 of the substrate 12.

Suitable application of the bonding layer 18 and of the skin adhesive layer 28 is critical for the pressure ulcer prevention article 10 to contribute towards controlling the micro-climate of the skin. In order to allow moisture to pass from the skin through the pressure ulcer prevention article 10 in a manner to prevent pressure ulcers, it has been found that the bonding layer 18 and the skin adhesive layer 28 are advantageously applied in a pattern. The patterning of the bonding layer 18 and skin adhesive layer 28 avoid occlusion of the breathable aspects of the substrate 12 and/or the cushioning layer 22. Referring to FIG. 2A, the substrate 12 includes a width 32 and a length 30 defining a substrate area. The bonding layer 18 may be disposed on the inner substrate surface 14 to cover less than 99% and more than 35%, and more specifically between 95% and 60% of the substrate area of the substrate 12. In an embodiment where the bonding layer 18 is an adhesive, the bonding layer 18 may be applied as, although not limited to, a non-uniform layer, such as a patterned layer, a sprayed pattern, or any of separate lines, stripes, swirls, or dots that may or may not be uniformly distributed on the inner substrate surface 14. As examples, stripes may be curved or substantially straight, and/or deposited as intersecting or non-intersecting stripes, and swirls and/or dots may intersect. The illustrated embodiment in FIGS. 2A and 2B, show the bonding layer 18 disposed on the inner substrate surface 14 as an adhesive in a series of uniform dots that covers more than approximately 50% of the substrate area. It should be understood that while the illustrated embodiment shows the bonding layer 18 as being disposed on the inner substrate surface 14 of the substrate 12, the bonding layer 18 may also be disposed on the substrate facing surface 26 of cushioning layer 22 as another option of disposing the bonding layer 18 between the substrate 12 and the cushioning layer 22.

Referring to FIG. 3A, the cushioning layer 22 includes a width 32 and a length 30 defining a cushioning layer area. The skin adhesive layer 28 may be disposed on the body facing surface 24 to cover less than 99% and more than 35%, and more specifically between 95% and 60% of the cushioning layer area of the cushioning layer 22. The skin adhesive layer 28 may be applied in patterns as those previously described for the bonding layer 18. The illustrated embodiment in FIGS. 3A and 3B, show the skin adhesive layer 28 disposed on the body facing surface 24 of the cushioning layer 22 as a series of uniform, dome-shaped dots that covers approximately 50% of the cushioning layer area. It should be understood that the skin adhesive layer 28 is not limited to the dome-shaped dots as shown in FIGS. 3A and 3B and may include other patterns that provide the specified coverage area.

The bonding layer 18 pattern and the skin adhesive layer 28 pattern may be arranged where the patterns of each layer completely overlap, partially overlap or do not overlap. For example, a bonding layer 18 pattern may cover 95% of the substrate area and a skin adhesive layer 28 pattern may cover 5% of the cushioning layer area, such that: i) complete overlap of the patterns allows for 95% coverage of the substrate area and the cushioning layer area that is within the specified range of coverage of less than 99% and more than 35% and allows moisture from the skin to pass through the pressure ulcer prevention article 10, ii) partial overlap of the patterns may allow for between 96% to 99% coverage of the substrate area and the cushioning layer area that is within the specified range of coverage of less than 99% and more than 35% and allows moisture from the skin to pass through the pressure ulcer prevention article 10, and iii) no overlap of the patterns may allow for 100% coverage of the substrate area and the cushioning layer area that is outside of the specified range of coverage and does not allow moisture to pass through the pressure ulcer prevention article 10. It should be understood that various patterns of the bonding layer 18 and of the skin adhesive layer 28 can be combined such that the combination of the bonding layer 18 and the skin adhesive layer 28 cover less than 99% and more than 35% of the cushioning layer area or of the substrate area.

Referring to FIGS. 4A and 4B, the pressure ulcer prevention article 10 may include a cushioning layer 22 that is of a smaller length 30 and a width 32 than the length 30 and the width 32 of the substrate 12. In this aspect, the substrate 12 extends beyond the cushioning layer 22 forming a border 40. The border 40 provides less bulk near the perimeter 50 of the pressure ulcer prevention article 10. The reduced bulk of the border 40 allows the substrate 12 to adhere closely to the wearer's skin such that the skin adhesive layer 28 on the border 40 has less propensity of lifting from the wearer's skin and ultimately prevents the pressure ulcer prevention article 10 from completely coming off of the wearer.

The dimensions and shape of the pressure ulcer prevention article 10 should be such that it is appropriately sized for its intended use. Generally, the size and shape of the pressure ulcer prevention article 10 is selected such that the pressure-prone area and some surrounding skin will be covered. For example, the shape of the pressure ulcer prevention article 10 could be symmetrical or asymmetrical. Shapes may include and are not limited to circles, ovals, squares, rectangles, or shapes that may accommodate a particular part of the body better than those previously listed, such as for example, hourglass-like or triangular-like. The shape of the pressure ulcer prevention article 10 can generally be any operative shape, or combination of shapes that may especially be capable of adapting to the curvature of a wearer's body during use. The pressure ulcer prevention article 10 may be different sizes to accommodate pressure- prone and shear-prone areas for people of different sizes and/or for use in different areas of the body. For example, a smaller sized pressure ulcer prevention article 10 could be for an elbow while a larger sized pressure ulcer prevention article 10 could be for the lower back. The pressure ulcer prevention article 10 may be available in sheets that could be cut to size or in prepared sizes. For example, sheets may be 20.32 cm X 25.4 cm, 20.32 cm X 27.94 cm, 22.86 cm X 30.48 cm, or any size suitable for consumer user. Prepared sizes may include 4.45 cm X 6.98 cm, 5.08 cm X 7.62 cm, 10.16 cm X 10.16 cm, or any other dimensions that provides an area of coverage suitable to the pressure prone area and the immediate surrounding skin. As such, in aspects where the pressure ulcer prevention article 10 includes a border 40, the border 40 dimensions may vary based on the particular pressure ulcer prevention article 10 use.

In an exemplary aspect, the pressure ulcer prevention article 10 includes a substrate 12 that is a 30 gsm polypropylene bonded carded material that is smooth roll calendared and is available under the trade name of SAWABOND. The polypropylene bonded carded material includes an inner substrate surface 14, a substrate area, and an opposite outer substrate surface 16. The pressure ulcer prevention article 10 includes a cushioning layer 22 that is a hydrophobic, open-celled, polyester foam having a thickness from about 2 mm to 5 mm available as 100 PPI Natural Regicell. The foam, cushioning layer 22 includes a body facing surface 24, a cushioning layer area, and an opposite substrate facing surface 26. The bonding layer 18 is a known construction adhesive such as Bostik Findley H2525A and is disposed between the inner substrate surface 14 of the polypropylene bonded carded material and the opposite substrate facing surface 26 of the foam, cushioning layer 22 such that the substrate 12 and the cushioning layer 22 are attached to the bonding layer 18. The bonding layer 18 is disposed in a pattern that covers 60% of the substrate area. The skin adhesive layer 28 is a DermaMed, medical grade, pressure-sensitive acrylic that is disposed on the body facing surface 24 of the foam, cushioning layer 22 in a pattern that covers 60% of the cushioning layer area. The bonding layer 18 pattern and the skin adhesive layer 28 pattern are arranged in such a way that the total adhesive coverage is 60%. The pressure ulcer prevention article 10 includes a border 40.

As previously indicated, control of moisture or transfer of moisture from the skin surface is essential in preventing pressure ulcers and is measured by the Moisture Vapor Transmission Rate (MVTR). Higher MVTR values provide for greater moisture vapor transmission. Four different pressure ulcer prevention articles 10 were compared to four commercial products. The pressure ulcer prevention article 10 codes include: 1 ) pressure ulcer prevention article 10 having a 30 gsm substrate 12 and 100% adhesive coverage (referred to as "High BW Full"), 2) pressure ulcer prevention article 10 having a 30 gsm substrate 12 and 60% adhesive coverage (referred to as "High BW Pattern" and is also the embodiment indicated as the exemplary aspect), 3) pressure ulcer prevention article 10 having a 17 gsm substrate 12 and 100% adhesive coverage (referred to as "Low BW Full") and , 4) pressure ulcer prevention article 10 having a 17 gsm substrate 12 and 60% adhesive coverage (referred to as "Low BW Pattern"). The commercial codes include: 1 ) ALLEVYN (Life Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, available from Smith & Nephew Inc., Andover, MA, USA), 2) AQUACELL (Foam Dressing Sacral, available from ConvaTec Inc., Bridgewater, NJ, USA), 3) MEPILEX (Border Sacrum Self Adherent, available from Molnlycke Health Care, Norcross, GA, USA), and 4) SHEARBAN (sheets, available from Tamarack Habilitation Technologies, Blaine, MN, USA). The exemplary pressure ulcer prevention article 10 (High BW Pattern) has MVTR values from about 8,600 g/m²/24 hrs to about 10,000 g/m²/24 hrs. The ALLEVYN product has a MVTR from about 2,200 g/m²/24 hrs to about 2,600 g/m²/24 hrs. The AQUACEL product has a MVTR from about 2,300 g/m²/24 hrs to about 2,400 g/m²/24 hrs. The MEPILEX product has a MVTR of less than about 500 g/m²/24 hrs. The SHEARBAN product has a MVTR of less than about 500 g/m²/24 hrs. Referring to FIG. 5, the exemplary pressure ulcer prevention article 10 ("High BW Pattern") and the "Low BW Pattern" pressure ulcer prevention article 10 (MVTR ranging from about 4,000 g/m²/24 hrs to about 5,800 g/m²/24 hrs) provide a greater moisture vapor transmission rate than several current, commercial products such that some of the commercial pressure ulcer products provide little to no ability for moisture to transfer from the skin. As previously presented, a low friction outer substrate surface 16 can aid in the prevention of pressure ulcers by reducing shear forces on the pressure-prone and shear-prone areas. In order to simulate conditions where a person would be most likely to develop pressure ulcers, the coefficient of friction (COF) of the outer surface 16 of the was determined using a low thread count (~ 300), white cotton sheet, similar to those found in hospitals (available from Target Corporation, Minneapolis, MN, USA). Test samples for all codes were prepared from the center portion of each product where the thickness of the product was greatest.

The dynamic COF is indicative of a material being able to reduce shear forces against a pressure-prone or shear-prone area. The term "dynamic COF" as used herein refers to the ratio of the force required to move one surface over another to the total force applied normal to those surfaces, once that motion is in progress. The exemplary pressure ulcer prevention article 10 (High BW Pattern) has a dynamic COF ranging from about 0.356 to about 0.375. The ALLEVYN product has a dynamic COF ranging from about 0.632 to about 0.815. The AQUACEL product has a dynamic COF ranging from about 0.410 to about 0.498. The MEPILEX product has a dynamic COF ranging from about 0.378 to about 0.469. The SHEARBAN product has a dynamic COF of about 0.185 to about 0.190. Referring to FIG. 6, the exemplary pressure ulcer prevention article 10 (High BW Pattern) provides a lower dynamic COF than several of the current, commercial products. Lower dynamic COF values provide for less resistance against another surface than higher dynamic COF values. As such, dynamic COF values for the pressure ulcer prevention article 10 that range from about 0.1 to about 0.9, and more specifically from about 0.1 to about 0.6 can provide for reduced shear forces against pressure-prone and shear-prone areas.

The term "static COF" as used herein refers to the ratio of the force required to move one surface over another to the total force applied normal to those surfaces, at the instant motion starts. The exemplary pressure ulcer prevention article 10 (High BW pattern) has a static COF ranging from about 0.791 to about 0.876. The ALLEVYN product has a static COF ranging from about 0.714 to about 0.922. The AQUACEL product has a static COF ranging from about 0.472 to about 0.553. The MEPILEX product has a static COF ranging from about 0.439 to about 0.546. The SHEARBAN product has a static COF of about 0.21 1 to about 0.219. Referring to FIG. 7, the MVTR and the dynamic COF values were charted for the pressure ulcer prevention article 10 codes and the commercial ALLEVYN, AQUACEL, MEPILEX, and

SHEARBAN products. The exemplary pressure ulcer prevention article 10 (High BW Pattern) delivers a combination of MVTR and COF values that address the moisture and friction factors related to the formation of pressure ulcers at a level that is not seen with current commercial products. As such, unexpected technical effects of the pressure ulcer prevention article 10 having a fibrous nonwoven substrate 12 include delivering comparable or lower COF values and comparable or higher MVTR values than commercial products having film substrates. Additionally, the pressure ulcer prevention article 10 codes can be non-absorbent with a hydrophobic cushioning layer 22; whereas the commercial product codes are designed for wound management and are absorbent (except for SHEARBAN).

As previously discussed, the pressure ulcer prevention article 10 can dissipate and absorb compressive and shear forces primarily through the cushioning layer 22. The compressive properties of an article may include: LC: Compression Linearity - a measure of the resistance to compression force; higher LC indicates higher resistance to compression,

WC: Compression Energy - a measure of the absorbed energy during compression force; higher WC indicates better absorption in compression energy, RC: Compression Resilience - a measure of the degree of recovery after compression force deformation; higher RC indicates lower energy absorption and thus better recovery,

EMC: Compression Strain - an indication of the compressibility of the material; higher EMC indicates ease of compression. EMC is calculated from To and TM such that EMC = (ΤΟ-ΤΜ)Π Ο ΟΟ, where To is the material thickness at 0.5 g/cm² and TM is the material thickness at 50 g/cm². As described, higher values of each of these properties is indicative of an article better able to dissipate or absorb compressive forces.

The following codes were evaluated and are compared in Table 1 : A) pressure ulcer prevention article 10 - High BW Full, B) pressure ulcer prevention article 10 - High BW Pattern C) pressure ulcer prevention article 10 - Low BW Full, D) pressure ulcer prevention article 10 - Low BW Pattern, E) ALLEVYN, F) AQUACELL, G) MEPILEX, and H) SHEARBAN. Overall, the four pressure ulcer prevention article 10 codes include higher values than several of the competitive products for most of these properties. The exemplary pressure ulcer prevention article 10 (High BW Pattern, Code B) includes higher values for all properties, LC, WC, RC and EMC, than all competitive codes.

TABLE 1 c LC Range LC WC Range WC RC Range RC EMC Range EMC

0 Aver(gf*cm/cm²> Aver(%) Aver(%) Aver¬

D age age age age E

A 0.913-1.035 0.979 2.56-4.74 3.87 36.03-96.18 51.96 29.71 -67.00 58.92

B 0.952-1.174 1.052 4.12-5.52 4.65 30.95-47.32 35.90 61.59-66.68 64.92

C 1.102-1.487 1.407 1.22-1.68 1.30 61.38-377.27 97.54 9.79-51.00 36.53

D 0.825-1.529 1.144 0.85-1.26 0.98 58.68-131.76 100.32 9.46-47.61 33.38

E 0.625-0.755 0.682 3.28-3.78 3.51 65.06-75.90 68.55 27.64-30.14 28.64

F 0.873-1.1 11 0.979 2.49-3.13 2.77 91.45-97.99 94.52 29.71 -34.83 32.41

G 0.606-0.699 0.650 2.03-2.56 2.25 83.54-96.55 87.89 30.78-34.46 33.09

H 0.423-0.515 0.453 0.129-0.163 0.146 44.19-64.71 54.99 16.32-18.95 17.71 The exemplary pressure article prevention article 10 code B (High BW Pattern) has better resistance to compressive forces than commercial codes E, G and H due to significantly higher LC values (based on Tukey-Kramer HSD analysis).

The exemplary pressure article prevention article 10 code B (High BW Pattern) has better absorption in compression energy than commercial codes E - H due to the significantly higher WC values (based on Tukey-Kramer HSD analysis).

The exemplary pressure article prevention article 10 code B (High BW Pattern) has better ease of compression than commercial codes E - H due to the significantly higher EMC values (based on Tukey-Kramer HSD analysis). One intended purpose of the pressure ulcer prevention article 10 is to prevent the formation of pressure ulcers. Thus, the pressure ulcer prevention article 10 should be applied to clean, unbroken skin including skin that is not cracked, does not have an open wound, is not weeping or exuding fluid, is not blistered, is unblemished, or any other condition that is not of the aforementioned nature. The unbroken skin may be cleansed with, for example, a mild soap and water, premoistened body wipes, and water-less cleansers. Cleansers that do not compromise the unbroken condition of the wearer's skin are most suitable. The skin should be dry before the application of the pressure ulcer prevention article 10 to the skin. For example, a cloth or paper towel may be used to dry the skin. Air dryers or other forms of drying that also do not compromise the unbroken condition of the skin may also be suitable. The pressure ulcer prevention article 10 can now be disposed onto the unbroken skin by adhering the skin adhesive layer 28 to the skin. The pressure ulcer prevention article 10 can be adhered to the skin in such a way to provide the maximum benefits of breathability, cushioning and low friction during wearer movement; that is, the pressure ulcer prevention article 10 is most suitably applied to the skin without gaps between the skin and the pressure ulcer prevention article 10, and/or without folds or bunching of the pressure ulcer prevention article 10 when applied to the skin. The pressure ulcer prevention article 10 may be worn for about 6 hours to about 7 days, and more typically from about 8 hours to about 12 hours. The actual wear time of the pressure ulcer prevention article 10 may be based on such factors related to the individual person including the condition of the skin in the pressure-prone and shear-prone area, mobility of the person, position changes of the affected area and/or body part, and the person's weight. There may be instances where several pressure ulcer prevention articles 10 can be worn during the wear time for a given person. While the pressure ulcer prevention article 10 has been described for use in the prevention and treatment of pressure ulcers, it should be understood that the pressure ulcer prevention article 10 embodiments may be applicable in other situations. For example, the control of moisture, pressure, shear, and frictional forces against the skin may also be advantageous in the prevention of blisters and calluses.

TEST METHODS

Test methods were completed under the following conditions: 23 ± 2°C (73.4 ± 3.6°F) and 50 ± 5% relative humidity.

Moisture Vapor Transmission Rate A suitable technique for determining the MVTR value of a film of the present disclosure is the test procedure standardized by INDA (Association of the Nonwoven Fabrick Industry), number IST- 70.4-99 which is incorporated by reference herein. The testing device which may be used for MVTR measurement is known as the Permatran-W Model 101 K manufactured by Mocon/Modern Controls, Inc., Minneapolis, MN, USA. The INDA test procedure is summarized as follows. A dry chamber is separated from a wet chamber of known temperature and humidity by a permanent guard film and the sample material to be tested. The purpose of the guard film is to define a definite air gap and to quiet or still the air in the air gap while the air gap is characterized. The dry chamber, guard film, and the wet chamber make up a diffusion cell in which the test film is sealed. A first test is made of the MVTR of the guard film and the air gap between an evaporator assembly that generates 100 percent relative humidity. Water vapor diffuses through the air gap and the guard film and then mixes with a dry gas flow that is proportional to water vapor concentration. The electrical signal is routed to a computer for processing. The computer calculates the transmission rate of the air gap and the guard film and stores the value for further use.

The transmission rate (TR) of the guard film and air gap is stored in the computer as CalC. The sample material is then sealed in the test cell. Again, water vapor diffuses through the air gap to the guard film and the test material and then mixes with a dry gas flow that sweeps the test material. Also, again, this mixture is carried to the vapor sensor. The computer then calculates the transmission rate of the combination of the air gap, the guard film, and the test material. This information is then used to calculate the transmission rate at which moisture is transmitted through the test material according to the equation: test material- test material.guardfilm.airgap- guardfilm.airgap The moisture vapor transmission rate ("MVTR") is then calculated as follows:

MVTR = fpsat(T) * RH / A * Psat(T) * (1-RH) wherein, f=the flow of water vapor in cm³ per minute; psat(T)=the density of water in saturated air at temperature T;

RH=the relative humidity at specified locations in the cell;

A=the cross sectional area of the cell; and

Psat(T)=the saturation vapor pressure of water vapor at temperature T.

Three samples of each code were tested at four cycles each; test side was skin adhesive layer.

Table 2 includes MVTR Values (g/m²/24 hrs) for the pressure ulcer prevention article 10 and for commercial products.

TABLE 2

Friction

The coefficient of friction was measured using ASTM D1894 - 14 (published March 2014). Test samples were prepared from the center portion of each product where the thickness of the product was greatest. The outer surface of each product sample was tested against a low thread count (~ 300), white cotton sheet. Table 3 includes static load, static COF, average load, and dynamic COF values for the SAWABOND substrate 12 of the pressure ulcer prevention article 10. Table 4 includes static load, static COF, average load, and dynamic COF values for the SHEARBAN product. Table 5 includes static load, static COF, average load, and dynamic COF values for the ALLEVYN product. Table 6 includes static load, static COF, average load, and dynamic COF values for the MEPILEX product. Table 7 includes static load, static COF, average load, and dynamic COF values for the AQUACEL product.

TABLE 3 -Pressure Ulcer Prevention Article 10 - High BW Full

TABLE 4 -Pressure Ulcer Prevention Article 10 - High BW Pattern

TABLE 5 -Pressure Ulcer Prevention Article 10 - Low BW Full

TABLE 6 -Pressure Ulcer Prevention Article 10 - Low BW Pattern

TABLE 7 - ALLEVYN

TABLE 8 - AQUACEL

TABLE 9 - MEPILEX

TABLE 10 - SHEARBAN

Compression

The compression properties of the four pressure ulcer prevention article codes and the four commercial codes are presented in Tables 1 1 - 18. The codes were tested using the Kawabata Evaluation System Compression Tester, also referred to as KES FB3 associated with the data acquisition program KES-FB System Ver. 7.09E/For Win98/2000/XP, available from Kato Tech Co., Ltd., Kyoto, JP. The measurements were performed according to the Kawabata testing procedure, with at least 3 samples cut to 10 cm X 10 cm in the material form. The product can be tested as it is without cutting. The results were averaged. Care was taken to not to overly handle and/or deform the samples. The test equipment was set up according to the instructions in the Kawabata manual and with the following settings:

Sensitivity: 2 X5 (on machine & computer program)

Stroke: 5 mm or 50 mm (on machine & computer program)

Plunger area: 2 cm² (on machine & computer program)

Compression Rate: 1 mm / 50 seconds at 5 mm stroke and 1 mm / 5 seconds at 50 mm stroke (on computer program)

Data process rate: 0.1 s/point (on computer program)

Fm Set: 5.0 (on machine)

Maximum Load: 50 g/cm2 (on computer program)

Gears: Red gear and Yellow gear; Red gear for 5 mm stroke and Yellow gear for 50 mm stroke depending on the thickness of sample (on machine); Red gear used only for SHEARBAN code. Pressure Levels 0.5 gf/cm² and 50 gf/cm² are used to determine the thickness at To and TM respectively and subsequent calculations of LC, WC, RC and EMC

The values for To, TM, EMC, LC, WC and RC were recorded.

Tukey-Kramer HSD analyses were also calculated from the results for LC, WC, RC, and EMC and are included in Tables 19 - 22.

TABLE 11 - CODE A: Pressure Ulcer Prevention Article - High BW Full

TABLE 13 - CODE C: Pressure Ulcer Prevention Article- Low BW Full

Sample LC WC RC TO TM EMC

(-) (gfcm/cm2) (%) (mm) (mm) (%)

1 1.121 1.37 56.93 1.221 0.732 40.05

2 1.487 1.45 61.38 1.025 0.635 38.05

3 1.391 1.36 76.47 1.001 0.610 39.06

4 1.796 0.44 377.27 1.001 0.903 9.79

5 1.666 1.22 64.75 1.001 0.708 29.27

6 1.494 1.46 52.05 1.001 0.610 39.06

7 1.102 1.68 58.33 1.196 0.586 51.00

8 1.436 1.40 63.57 1.025 0.635 38.50

9 1.253 1.30 94.62 1.025 0.610 40.49

10 1.320 1.37 70.07 1.025 0.610 40.49

Average 1.406 1.31 97.54 1.052 0.664 36.53

Std Dev 0.221 0.33 99.02 0.083 0.096 10.74

TABLE 14 - CODE D: Pressure Ulcer Prevention Article - Low BW Pattern

Sample LC WC RC TO TM EMC

(-) (gfcm/cm2) (%) (mm) (mm) (%)

1 1.392 1.02 97.06 1.025 0.732 28.59

2 1.214 1.26 65.87 1.025 0.610 40.49

3 1.238 1.21 58.68 1.050 0.659 37.24

4 0.945 0.98 103.06 1.050 0.635 39.52

5 1.160 0.85 131.76 1.025 0.732 28.59

6 1.529 1.12 87.5 1.025 0.732 28.59

7 0.975 1.19 64.71 1.025 0.537 47.61

8 0.959 1.11 73.87 1.025 0.562 45.17

9 0.825 0.20 190.00 1.025 0.928 9.46

10 1.201 0.88 130.68 1.025 0.732 28.59

Average 1.144 0.98 100.32 1.030 0.686 33.38

Std Dev 0.219 0.31 40.86 0.010 0.112 11.10

TABLE 15 - CODE E: ALLEVYN

Sample LC WC RC TO TM EMC

(-) (gfcm/cm2) (%) (mm) (mm) (%)

1 0.672 3.65 67.67 7.324 5.151 29.67

2 0.688 3.40 72.35 7.153 5.176 27.64

3 0.714 3.57 68.07 7.104 5.103 28.17

4 0.671 3.52 69.03 7.153 5.054 29.34

5 0.696 3.61 75.90 7.324 5.249 28.33

6 0.755 3.78 66.93 7.129 5.127 28.08

7 0.634 3.52 65.06 7.373 5.151 30.14 8 0.625 3.28 66.46 7.153 5.054 29.34

9 0.696 3.44 66.28 7.153 5.176 27.64

10 0.669 3.35 67.76 7.129 5.127 28.08

Average 0.682 3.51 68.55 7.199 5.137 28.64

Std Dev 0.038 0.15 3.24 0.099 0.059 0.90

TABLE 16 - CODE F: AQUACELL

Sample LC WC RC TO TM EMC

(-) (gfcm/cm2) (%) (mm) (mm) (%)

1 1.018 2.98 94.97 3.564 2.393 32.86

2 1.1 11 2.78 93.17 3.369 2.368 29.71

3 1.038 3.04 91.45 3.564 2.393 32.86

4 0.941 2.93 92.83 3.589 2.344 34.69

5 0.950 3.13 92.65 3.784 2.466 34.83

6 0.907 2.49 97.99 3.369 2.271 32.59

7 1.019 2.55 96.08 3.369 2.368 29.71

8 0.873 2.61 95.40 3.589 2.393 33.32

9 1.023 2.56 94.53 3.369 2.368 29.71

10 0.913 2.62 96.18 3.394 2.246 33.82

Average 0.980 2.77 94.53 3.496 2.361 32.41

Std Dev 0.074 0.23 2.00 0.143 0.063 2.00

TABLE 17 - CODE G: MEPILEX

Sample LC WC RC TO TM EMC

(-) (gfcm/cm2) (%) (mm) (mm) (%)

1 0.615 2.29 84.72 4.395 2.905 33.90

2 0.640 2.11 90.05 4.102 2.783 32.16

3 0.628 2.03 96.55 4.102 2.808 31.55

4 0.673 2.30 84.78 4.102 2.734 33.35

5 0.653 2.43 83.54 4.321 2.832 34.46

6 0.667 2.28 85.53 4.126 2.759 33.13

7 0.658 2.09 93.78 4.126 2.856 30.78

8 0.606 2.11 88.15 4.102 2.710 33.93

9 0.661 2.30 87.83 4.126 2.734 33.74

10 0.699 2.56 83.98 4.321 2.856 33.90

Average 0.650 2.25 87.89 4.182 2.798 33.09

Std Dev 0.028 0.17 4.40 0.1 15 0.064 1.20 TABLE 18 - CODE H: SHEARBAN

- LC: Means Comparisons for all pairs using Tukey-Kramer HSD Connecting Letters

CODE LC

C-Low BW Full A 1.4066

D-Low BW Pattern B 1.1438

B-High BW Pattern B 1.0520

A-High BW Full B 0.9795

F-AQUACELL B 0.9793

E-ALLEVYN C 0.6820

G-MEPILEX C 0.6500

H-SHEARBAN D 0.4529

Levels not connected by same letter are significantly different.

- WC: Means Comparisons for all pairs using Tukey-Kramer HSD Connecting Letters

Code WC

B-High BW Pattern A 4.6510

A-High BW Full B 3.8660

E-ALLEVYN B 3.5120

F-AQUACELL C 2.7690

G-MEPILEX D 2.2500

C-Low BW Full E 1.3050

D-Low BW Pattern E 0.9820

H-SHEARBAN F 0.1461 Levels not connected by same letter are significantly different.

TABLE 21 - RC: Means Comparisons for all pairs using Tukey-Kramer HSD Connecting Letters Report

Levels not connected by same letter are significantly different.

TABLE 22 - EMC: Means Comparisons for all pairs using Tukey-Kramer HSD Connecting Letters Report

Levels not connected by same letter are significantly different. When introducing elements of the present disclosure or the preferred embodiment(s) thereof, the articles "a", "an", "the" and "said" are intended to mean that there are one or more of the elements. The terms "comprising", "including" and "having" are intended to be inclusive and mean that there may be additional elements other than the listed elements. Many modifications and variations of the present disclosure can be made without departing from the spirit and scope thereof. Therefore, the exemplary embodiments described above should not be used to limit the scope of the invention

Claims

WHAT IS CLAIMED IS:

1. A pressure ulcer prevention article comprising:

a substrate with an inner substrate surface having a substrate area and an opposite outer substrate surface; wherein the opposite outer substrate surface has a dynamic coefficient of friction ranging from 0.1 to 0.6; a bonding layer disposed on the inner substrate surface; a cushioning layer with a body facing surface having a cushioning layer area and an opposite substrate facing surface; and a skin adhesive layer disposed on the body facing surface; wherein the cushioning layer is disposed between the bonding layer and the skin adhesive layer and wherein the pressure ulcer prevention article has a moisture vapor transmission rate ranging from 2,400 gm/m²*day to 10,000 gm/m²*day.

2. The pressure ulcer prevention article of claim 1 further comprising a moisture vapor transmission rate ranging from 5,000 gm/m²*day to 9,000 gm/m²*day.

3. The pressure ulcer prevention article of claim 1 or claim 2 wherein the bonding layer further comprises between 60% and 95% coverage of the substrate area.

4. The pressure ulcer prevention article of claim 1 or claim 2 wherein the skin adhesive layer further comprises between 60% and 95% coverage of the cushioning layer area.

5. The pressure ulcer prevention article of claim 1 or claim 2 wherein the cushioning layer further comprises a compression energy value ranging from 2 gfcm/cm² to 5 gfcm/cm².

6. The pressure ulcer prevention article of claim 1 or claim 2 wherein the substrate comprises a fibrous nonwoven.

7. A method of preventing pressure ulcers on unbroken skin comprising the steps of:

cleansing the unbroken skin with a mild soap and water; drying the unbroken skin with a cloth or paper towel; providing a pressure ulcer prevention article comprising: a substrate with an inner substrate surface having a substrate area and an opposite outer substrate surface; wherein the opposite outer substrate surface has a dynamic coefficient of friction ranging from 0.1 to 0.6; a bonding layer disposed on the inner substrate surface; a cushioning layer with a body facing surface having a cushioning layer area and an opposite substrate facing surface; and a skin adhesive layer disposed on the body facing surface; wherein the cushioning layer is disposed between the bonding layer and the skin adhesive layer and wherein the pressure ulcer prevention article has a moisture vapor transmission rate ranging from 2,400 gm/m²*day to 10,000 gm/m²*day; and disposing the pressure ulcer prevention article to the unbroken skin by adhering the skin adhesive layer to the skin.

8. The method of claim 10 further comprising the step of removing the pressure ulcer prevention article from the skin after a wear time that ranges from about 8 hours to less than about 7 days.

9. A pressure ulcer prevention article comprising:

a substrate with an inner substrate surface having a substrate area and an opposite outer substrate surface; wherein the substrate is a polypropylene bonded carded material and the opposite outer substrate surface has a dynamic coefficient of friction ranging from 0.1 to 0.6; a bonding layer disposed on the inner substrate surface; wherein the bonding layer covers between 60% and 95% of the substrate area; a cushioning layer with a body facing surface having a cushioning layer area and an opposite substrate facing surface; wherein the cushioning layer comprises a foam having a compression energy value ranging from 2 gfcm/cm² to 5 gfcm/cm²; and a skin adhesive layer disposed on the body facing surface; wherein the skin adhesive layer covers between 60% and 95% of the cushioning layer area, and wherein the cushioning layer is disposed between the bonding layer and the skin adhesive layer, and wherein the pressure ulcer prevention article has a moisture vapor transmission rate ranging from 2,400 gm/m²*day to 10,000 gm/m²*day.

10. The pressure ulcer prevention article of claim 1 1 wherein the opposite outer substrate surface of the polypropylene bonded carded material further comprises a dynamic coefficient of friction ranging from 0.1 to 0.6.

11. The pressure ulcer prevention article of claim 1 1 or claim 12 wherein the cushioning layer further comprises a hydrophobic, open-celled foam.

12. A pressure ulcer prevention article comprising:

a substrate with an inner substrate surface having a substrate area and an opposite outer substrate surface; wherein the substrate is a polypropylene bonded carded material; a bonding layer disposed on the inner substrate surface; a cushioning layer with a body facing surface having a cushioning layer area and an opposite substrate facing surface; wherein the cushioning layer comprises a foam; and a skin adhesive layer disposed on the body facing surface.

13. The pressure ulcer prevention article of claim 15 wherein the opposite outer substrate surface of the polypropylene bonded carded material further comprises a dynamic coefficient of friction ranging from 0.1 to 0.6.

14. The pressure ulcer prevention article of claim 15 wherein the bonding layer further comprises between 60% and 95% coverage of the substrate area.

15. The pressure ulcer prevention article of claim 15 wherein the cushioning layer further comprises a compression energy value ranging from 2 gfcm/cm² to 5 gfcm/cm².

16. The pressure ulcer prevention article of claim 15 wherein the skin adhesive layer further comprises between 60% and 95% coverage of the foam layer area.

17. The pressure ulcer prevention article of claim 15 further comprises a moisture vapor transmission rate ranging from 2,400 gm/m²*day to 10,000 gm/m²*day.