Treated disposable articles for reducing skin breakdown

Details Treated disposable articles for reducing skin breakdown Treated disposable articles for reducing skin breakdown

1995-01-19

2003-05-06

Weiss, John G. (Department: 3761)

Surgery

Means and methods for collecting body fluids or waste material

Absorbent pad for external or internal application and...

C604S367000, C252S062200, C428S208000

Reexamination Certificate

active

06559353

ABSTRACT:

The present invention relates to treated disposable absorbent articles such as diapers, incontinent briefs, incontinent pads, bandages, dressings and the like which are effective in preventing or reducing diaper rash (contact irritant dermatitis) particularly in infants and the occurrence of bed sores and ulcerations in non-ambulatory, incontinent subjects. More particularly, the invention relates to the dry treated cover sheet useful in the fabrication of such articles.
Existing absorbent articles such as diapers, incontinent briefs, feminine hygiene pads and incontinent under pads conventionally include a topsheet or cover sheet. The topsheet is that part of the absorbent article which is in direct contact with the skin of the user. Chemical treatment of these topsheets has heretofore been limited to the addition of surface active agents to facilitate the transfer of liquid waste through the topsheet and into an absorbent core. To date, attempts to incorporate skin softeners and protectants, and/or friction reducing emollients into the topsheet has resulted in the repelling of the body fluids, rendering the absorbent articles non-functional for their intended purpose.
One object of the invention is to apply skin softeners, protectants and friction reducing emollients to a topsheet in a manner that will be effective to transfer these softeners, protectants and emollients to the skin by contact, without affecting the functionality of the absorbent article.
In U.S. Pat. No. 5,091,102 issued to the inventor herein there is disclosed a method of making a substantially flexible dry matrix using no water other than that naturally present in the matrix by utilizing non-aqueous treatment solutions comprising cationic surfactants. The patent additionally discloses incorporating propylene glycol and anti-microbial compounds in the non-aqueous treatment solutions.
The substantially dry matrices prepared according to that patent are composed only of water soluble chemicals and compounds. The addition of water or an aqueous liquid is required in order to solubilize the treatment compounds and render the articles functional.
In applicant's co-pending application, Ser. No. 08/171,676 filed Dec. 22, 1993, there is disclosed the addition of nonwater soluble compounds such as mineral oil, silicones and the like to the non-aqueous treatment solution. When water or other aqueous liquid is added to the substantially dry treated matrices, an “instant emulsion” is created which transfers the non-water soluble compound to the surface that the matrix contacts in use.
The instant application is directed to a substantially dry matrix which has been treated with a non-aqueous treatment solution comprising non-water soluble skin softening protectant and emollient compounds, non-ionic and cationic surfactants, humectants preferably propylene glycol, and preferably an anti-microbial compound.
The treated article containing the non-aqueous treatment solution, is capable of transferring the skin softening protectant and emollient compounds to the skin by contact while allowing the treated article to transfer bodily fluids through the treated topsheet and into the absorbent core.
The absorbent articles, of the invention, comprise (a) a liquid impervious backing sheet; (b) a flexible absorbent core positioned between the backing sheet and the topsheet and (c) a relatively hydrophobic, liquid pervious topsheet positioned on top of the flexible absorbent core, which effects direct skin contact. More specifically, the present invention is directed to the unique topsheet treatment for these absorptive articles which will allow the discharged body waste to pass into the absorptive layer (core) and at the same time transfer to the exposed skin in contact with the absorptive device, pharmacologic agent(s) that on delivery to the skin will function (a) to protect the subject's skin from wetness contained in the moisture absorbent layer and thus help prevent or reduce excessive hydration and skin irritation; (b) to have activity which will serve to reduce the ammonia producing organisms or enzymes which can aggravate contact irritation; (c) to reduce the odors due to waste decomposition in an occlusive anaerobic environment; and (d) in the of case of adult, particularly non-ambulatory, incontinent underpads, briefs and liners, to help reduce the skin maceration, pressure ulcers and bed sores that otherwise frequently occur by preventing skin friction and shearing and their damaging effects on the skin. The uniquely treated topsheet of the invention can also substantially reduce or eliminate the need for using creams, ointments or powders.
BACKGROUND OF THE INVENTION
Diaper dermatitis is the most common cutaneous disorder of infancy and early childhood, however this condition is not limited to infants. Any individual who suffers from incontinence may develop this condition; this ranges from newborns to the elderly, to the critically ill and/or non-ambulatory individuals.
In the case of elderly, non-ambulatory and incontinent individuals, diaper dermatitis is simply the primary irritant becoming a variable symptom complex, incorporating a combination of irritating factors, including pressure, friction, shearing, heat, moisture and the physiological effects of ageing on the body. Although frequently no more than a disagreeable nuisance, with infants and babies, this chain of events in elderly individuals can cause eruptions which progress to secondary infection and ulceration and become complicated by other disorders which can and are life threatening.
For years, ammonia produced by bacterial breakdown of urea in the urine was thought to be a major factor in the etiology of diaper rash. Some recent studies refute the role of ammonia and urea-splitting bacteria as the underlying cause of this disorder and incriminate instead a combination of wetness, impervious diaper coverings and fungi, such as Candida albicans as causative factors in the initiation of diaper rash eruptions and skin ulceration.
Investigators now believe the activity of proteolytic and lipolytic fecal enzymes present in a mixture of feces and urine to be a major factor in producing skin irritation. Urine in contact with the fecal enzymes can result in production of ammonia which raises skin pH to levels of 6.0 and above, increasing the fecal proteolytic and lipolytic enzymatic activity which in turn produces metabolites resulting in diaper rash. Urine itself contributes to diaper dermatitis by adding moisture to the diaper environment, diminishing the barrier property of the skin, thereby enhancing the skin's susceptibility to irritation of all types, including that caused by the decomposing urine and fecal metabolic products.
The occlusive nature of the diaper or incontinence brief contributes to the excess hydration of the exposed skin and to the loss of the normal barrier functions resulting in the increased vulnerability of the skin to toxic chemicals and microbial stimuli as well as to infection from fungal and other microbial organisms. Hydration and loss of the skin's normal barrier function is aggravated, particularly if left in an occluded environment for long periods of time. These results can occur with either baby diapers or with adult incontinent briefs and underpads, where, due to thinner and less healthy epidermal tissue the resulting ulcerations can become life threatening. Conservative management, in preventing and reducing diaper dermatitis and pressure ulcers is directed at keeping the skin clean and dry and by limiting irritation and maceration by the judicious use of disposable garments designed to help prevent such conditions. Most important is the prevention of irritation as a consequence of frictional shear on the skin particularly in non-ambulatory adults especially the elderly and incontinent adult.
Incontinent articles are known for containment of urine and feces. These are formed from three basic structural elements: (a) a liquid impervious backing sheet, (b) an absorbent core which may comprise one or more

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