Synthetic resins or natural rubbers -- part of the class 520 ser – Synthetic resins – Processes of preparing a desired or intentional composition...
Reexamination Certificate
1995-02-27
2002-12-10
Page, Thurman K. (Department: 1615)
Synthetic resins or natural rubbers -- part of the class 520 ser
Synthetic resins
Processes of preparing a desired or intentional composition...
C424S078350, C424S078020, C424S445000, C514S925000, C514S928000
Reexamination Certificate
active
06492434
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention is directed to methods for inhibiting the formation of surface skin ulcers by using cyanoacrylate adhesives. The cyanoacrylate adhesive to be used can be stored in dispensers for single or repeated/intermittent use and can be applied to the skin by spraying, painting, etc. of the adhesive.
2. State of the Art
Cyanoacrylate adhesives have been suggested for a variety of adhesive purposes including glues and adhesives for surgical treatments. In particular, cyanoacrylate adhesives of formula I:
wherein R is an alkyl or other suitable substituents are disclosed in U.S. Pat. Nos. 3,527,224; 3,591,676; 3,667,472; 3,995,641; 4,035,334; and 4,650,826. Typically, when used as adhesives for treating living tissues, the R substituent is alkyl of from 2 to 8 carbon atoms and most often is butyl (e.g., n-butyl).
The suggested medical uses for cyanoacrylate adhesives include surgical environments wherein the cyanoacrylate adhesives are utilized to adhere internal tissues, repair surgical wounds and mitigate bleedings, e.g., as an alternative to sutures or as a hemostat. Typically, treatment is limited to a small defined broken skin area.
In contrast to such prior art uses of cyanoacrylate adhesives, this invention is directed to methods for inhibiting the formation of skin ulcers including, by way of example, decubitus ulcers (bedsores) and diabetic ulcers by topical application of cyanoacrylate adhesives on intact unbroken skin.
Decubitus ulcers arise from the deprivation of nutrients to the tissue arising from prolonged pressure which leads to ischemia and are common in situations were the patient remains in a fixed position for prolonged periods (e.g., long term bed or wheelchair confinement). This often occurs in tissue overlying bony prominences. However, other factors such as skin irritation (due to, for example, friction and shearing forces arising from bedding materials and clothing), moisture (bodily fluid contamination), and poor skin integrity, especially in older, compromised patients, can exacerbate and accelerate ulcer formation and skin breakdown. The effect of friction in addition reduces the amount of pressure needed for skin breakdown. When the skin becomes broken, the potential for infection and morbidity increase significantly. Care and handling of the ulcerated area become more difficult and expensive. Typically, decubitus ulcer formation is preceded by reddening of nutrient deprived skin which, with continued irritation, develops into the open bedsore (i.e., a skin ulcer).
Diabetic ulcers are formed by deprivation of nutrients to the tissue as a result of the diabetic condition including neuropathy (lack of pain sensation), poor circulation in the patient, etc. In particular, diabetic ulcer formation in nutrient deprived tissues is facilitated by skin irritation much as with decubitus ulcer formation due to, for example, bodily fluid contamination, friction, shearing forces, and poor skin integrity. Typically, diabetic ulcer formation is preceded by reddening of nutrient deprived tissue which, with continued irritation, develops into an open skin ulcer.
In any event, once formed, skin ulceration is prone to severe infection and prolonged healing. Therapies for treating skin ulcers have proven to be unsuccessful particularly in cases where the conditions causing skin ulceration remain unchanged. Accordingly, the health care industry has focused on measures to prevent the formation of skin ulcers as the best approach for treating such ulcers. In the case of decubitus ulcers, conventional prophylactic methods include, by way of example, the use of sheepskin pads, foam mattresses, specialized beds, emollients and the like. In the case of diabetic ulcers, conventional prophylactic methods include, by way of example, the use of pads in areas of nerve damage due to neuropathy (to prevent the patient from inflicting injuries to these areas due to lack of sensation), methods to enhance blood circulation in the patient, etc.
Notwithstanding such therapies, skin ulceration is a continuing and expanding problem especially with diabetic patients, bed or wheelchair ridden patients, etc. as a recent study indicates that the prevalence of pressure ulcers in hospital populations has increased by about 21% from 1989 to 1993. Meehan,
Advances in Wound Care,
Vol. 7, No. 3, pp. 27-38, 1994. Accordingly, there is an ongoing need to provide better methods for inhibiting skin ulceration and reducing the effects of pressure and irritation.
SUMMARY OF THE INVENTION
This invention is drawn to methods for inhibiting surface skin ulceration including, by way of example, decubitus ulcers (bedsores) and diabetic ulcers. The methods involve applying cyanoacrylate adhesive, particularly n-butyl cyanoacrylate adhesive, onto skin areas prone to surface skin ulceration so as to form a resilient yet flexible, waterproof polymer layer over such skin areas. In turn, this polymer layer increases the skin integrity while reducing skin irritation to the underlying skin thereby inhibiting these factors which are known to increase skin ulceration.
The methods described herein can be used by themselves to inhibit formation of surface skin ulcers, but preferably are used in conjunction with existing regimens for inhibiting formation of surface skin ulcers.
Accordingly, in one of its method aspects, this invention is directed to a method for inhibiting the formation of surface skin ulcers which method comprises:
applying to an intact skin surface area prone to ulcer formation, a sufficient amount of a cyanoacrylate adhesive so as to cover said area; and
polymerizing the cyanoacrylate adhesive so as to form a flexible, waterproof, adhesive polymer coating which adheres to the area where the adhesive was applied,
wherein the cyanoacrylate, in monomeric form, is represented by formula I:
where R is selected from the group consisting of:
alkyl of 2 to 10 carbon atoms,
alkenyl of 2 to 10 carbon atoms,
cycloalkyl groups of from 5 to 8 carbon atoms,
phenyl,
2-ethoxyethyl,
3-methoxybutyl,
and a substituent of the formula:
wherein each R′ is independently selected from the group consisting of:
hydrogen and methyl, and
R″ is selected from the group consisting of:
alkyl of from 1 to 6 carbon atoms,
alkenyl of from 2 to 6 carbon atoms,
alkynyl of from 2 to 6 carbon atoms,
cycloalkyl of from 3 to 8 carbon atoms,
aralkyl selected from the group consisting of benzyl, methylbenzyl and phenylethyl,
phenyl, and
phenyl substituted with 1 to 3 substituents selected from the group consisting of hydroxy, chloro, bromo, nitro, alkyl of 1 to 4 carbon atoms, and alkoxy of from 1 to 4 carbon atoms.
Preferably R is alkyl of from 2 to 10 carbon atoms and more preferably alkyl of from 2 to 8 carbon atoms. Even more preferably, R is butyl or octyl and most preferably, R is n-butyl.
In a preferred embodiment, the cyanoacrylate is applied at an amount of at least 0.02 milliliter (ml), and preferably from about 0.02 to about 0.2 ml, of cyanoacrylate adhesive per square centimeter of skin which is to be covered.
In another preferred embodiment, the cyanoacrylate adhesive to be applied to the skin has a viscosity of from greater than 1 to about 100 centipoise at 20° C. More preferably, the cyanoacrylate adhesive is in monomeric form and has a viscosity of from greater than 1 to about 20 centipoise at 20° C. In still another preferred embodiment, a gel having a viscosity of up to about 50,000 centipoise or more at 20° C. can be used.
As used herein, the following terms have the following meanings:
The term “cyanoacrylate adhesive” refers to adhesive formulations based on cyanoacrylate monomers of formula I:
where R is selected from the group consisting of alkyl of 2 to 10 carbon atoms, alkenyl of 2 to 10 carbon atoms, cycloalkyl groups of from 5 to 8 carbon atoms, phenyl, 2-ethoxyethyl, 3-methoxybutyl, and a substituent of the formula:
where each R′ is independently selected from the group consisting of hydrogen and methyl and R″ is selected from the
Barley, Jr. Leonard V.
Byram Michael M.
Greff Richard J.
Tighe Patrick J.
Burns Doane Swecker & Mathis L.L.P
Flowers Park Ltd.
Fubara Blessing
Page Thurman K.
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