Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Wearing apparel – fabric – or cloth
Reexamination Certificate
2000-01-24
2002-08-27
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Wearing apparel, fabric, or cloth
C424S400000, C424S443000
Reexamination Certificate
active
06440437
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to wet wipes and wipe-type products. More particularly, the present invention particularly relates to wet wipes and wipe-type products that can be used for a variety of purposes including cleaning, cosmetics removal, and sanitation comprising an oil-in-water emulsion composition solution that cleans the surface of the skin and provides enhanced skin health benefits.
BACKGROUND OF THE INVENTION
The stratum corneum is the outer-most layer of the skin and is responsible for regulating skin water levels and functioning as a barrier against chemicals and other stressors found in the environment. The complex arrangement of lipids in the intercellular space of the stratum corneum is responsible for the establishment of normal barrier function. Multi-layered structures of cholesterol, ceramides, and fatty acids, as well as some other minor lipids, provide the major barrier to the transport of hydrophillic substances into the or through the skin. The link between the barrier function and skin health can be observed through skin inflammation that results from the extraction of lipids from the skin.
In addition to inflammation, disrupted barrier function can result in a number of skin conditions, most notably, dry skin. Moisturizers that consist of occlusive chemistries or humectants are commonly utilized to treat dry skin.
Diaper dermatitis, in infants and adults, is a genre of skin conditions that, in large part, originate from impaired barrier function. Impairment of the skin barrier can result from a variety of factors, including; increased skin hydration due to the occlusion of the skin caused by diapers, enzymatic skin damage due to fecal and urinary enzymes, physical abrasion caused by diapers, washcloths, and wet wipes, and removal of skin lipids by surfactant associated with bathing and cleaning.
Occlusion of the skin results in an increased skin hydration due to the blocking of evaporative water loss from the surface of the skin. The hydration level of diapered skin may reach between five to ten times that of undiapered skin. Frequent contact of diapered skin with urine may also contribute to increased skin hydration. Increased skin hydration disrupts skin lipid organization in the stratum comeum. This disruption may increase the skin permeability allowing the penetration of irritants from feces and urine into the skin.
Results from studies performed on hairless mice reveals the fecal enzymes, specifically proteases and lipases, are major skin irritants in the diapered skin environment. Fecal proteases degrade the stratum corneum proteins resulting in inflammatory reactions and facilitation of the penetration of low molecular weight irritants. Urine was observed to elevate skin pH thereby facilitating enzymatic action on the skin as well causing inflammatory reactions in the skin.
Diapered skin is typically cleaned by the application of cotton wash cloths or disposable wet wipes. The effect on the skin by the wet wipes depends upon the materials and surfactant systems used for the wipes. Diapered skin is normally cleansed several times a day with wipes utilizing solutions containing surfactants. Surfactants are known to extract lipids from the stratum corneum or disorganize the lipid structure within the stratum comeum, thereby decreasing the barrier function. The wet wipe and wipe-type product material can cause physical abrasion damage to the skin and can lead to an increase in transepidermal water loss, an indication of decreased barrier function. Other instances from which skin barrier function interruption results are frequent hand washing and contact dermatitis originating from harsh surfactants and other chemical irritants.
Once the skin barrier has been compromised, a series of events occur within the skin to synthesize and organize lipids to restore the barrier function. The body naturally repairs defects in the skin barrier function by increasing the production of key lipids found in the skin, such as cholesterol, ceramides, and fatty acids, and key lipid synthesizing enzymes. Two known environmental conditions inhibit the natural skin barrier repair mechanisms relating to diapered skin. The first condition is a neutral skin pH, and the other condition is the occlusion of the skin. Chronic exposure to feces and urine, as well as the continued occlusion of the skin, therefore, leads to chronic disruption of the skin barrier function.
Wet wipes are well known commercial consumer products that have been available in many forms. Perhaps the most common form of wet wipes has been a stack of moistened sheets that have been packaged in a plastic container. The wet wipes have been made from a variety of materials that have been moistened with a variety of suitable mild surfactant-based solutions. Such wet wipes have been used for baby wipes, hand wipes, household cleaning wipes, industrial wipes, body and facial wipes, and the like.
Typically, such conventional wet wipes have included a single layer of a substantially homogeneous material. For example, conventional wet wipes have included an air laid web of fibers that are uniformly mixed or distributed throughout the web. The wipes have included polymeric fibers such as polyester, polyethylene and polypropylene and natural or synthetic fibers such as cellulosic fibers. Other conventional wet wipes have included a coformed web of polypropylene and cellulosic fibers wherein the fibers are uniformly mixed throughout the web.
However, other forms of a wet wipe or wipe-type product includes a wipe product having a nonwoven, layered basesheet. The layered basesheet may include at least two layers positioned in facing relation with each other wherein one of the layers includes fibers that are not included in the other layer. Such an arrangement may be wherein at least one of the layers includes polyethylene fibers and at least one of the layers includes polypropylene fibers. In alternate forms, the layers may include similar materials, but in differing amounts. The different layers can be configured to provide different physical properties, such as softness, to the wipe product while another layer may be configured to provide other properties, such as strength, to the wipe product.
The balance of physical properties, such as softness, flexibility, strength, integrity and resiliency has not been completely optimized. Topical chemistry may be used to enhance the delivered product properties of the wet wipes and wipe-type products. This has been particularly true for those users desiring improved skin health or the ability to impart skin health benefits. The skin health benefits of the wipe product or the skin health benefits imparted from the wipe product may be perceived to be particularly important for body wipes which are intended for repeated contact the skin of an adult to an infant.
Thus, what is needed in the art are products that help maintain skin barrier function, particularly in the diapered skin environment, such as a wet wipe or wipe-type product that: a) deposits suitable chemistries on the skin to enhance skin barrier; b) minimizes physical damage to the skin due to wiping; c) leaves the skin feeling soft and supple; and, d) provides a long lasting benefit until the next wiping event while still providing effective cleaning while providing skin barrier enhancement.
SUMMARY OF THE INVENTION
It has now been discovered that an improved wet wipe or wipe-type product, used for a variety of purposes including cleaning, cosmetics removal, and sanitation, that enhances skin barrier can be made applying, absorbing into, or otherwise wetting the wet wipe or wipe-type product with an oil-in-water emulsion composition comprising a natural fat or oil, sterol or sterol derivative, humectant, emulsifying surfactants and surfactant combinations having an HLB range of about 7 to about 18, and water. The composition also readily transfers from the wet wipe or wipe-type sheet onto the skin being contacted with the sheet to provide enhanced skin barrier benefits while providing desired
Krzysik Duane Gerard
Lange Beth Anne
Nelson Brenda Marie
Otts David Roland
Charlier Patricia A.
Howard S.
Kimberly--Clark Worldwide, Inc.
Page Thurman K.
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