Drug – bio-affecting and body treating compositions – Solid synthetic organic polymer as designated organic active... – Polymer from ethylenic monomers only
Reexamination Certificate
1994-04-22
2002-01-29
Levy, Neil S. (Department: 1616)
Drug, bio-affecting and body treating compositions
Solid synthetic organic polymer as designated organic active...
Polymer from ethylenic monomers only
C424S078020, C424S078050, C424S078060, C424S078070, C424S078270, C424S407000, C523S111000
Reexamination Certificate
active
06342213
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention is directed to methods for treating non-suturable wounds by using cyanoacrylate adhesives. The cyanoacrylate adhesive to be used can be stored in dispensers for single or repeated/inter-mittent use.
2. State of the Art
Cyanoacrylate adhesives have been suggested for a variety of adhesive purposes including glues and surgical adhesives. In particular, cyanoacrylates of formula I:
wherein R is an alkyl or other suitable substituent 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 an adhesive for 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 adhesive is utilized, e.g., as an alternative to sutures or as a hemostat and, as such, are necessarily employed in a sterile environment. See, for example, Halpern, U.S. Pat. No. 3,667,472, and Robertson, et al., U.S. Pat. No. 3,722,599. In such surgical environments, the cyanoacrylate adhesive is applied to the soft tissue under sterile conditions and, in the presence of water or protein found in soft tissue, the adhesive bonds to the tissue as well as polymerizes which, in the case of adhesive sutures, joins the separated sections of soft tissue together.
Contrarily, most small wounds are neither treated in a surgical setting nor in a sterile environment. In a typical home setting, small wounds are generally cleaned and are either left exposed (generally if not bleeding) or are covered with a bandage (generally the case where minor bleeding occurs or where there is irritation). In either case, the wound is usually left to heal on its own over time with the accompanying discomfort during this period.
In any event, the art teaches against the use of alkyl cyanoacrylates on human skin tissue where it will be absorbed internally because of the lack of suitable low toxicity and/or adequate resorption/absorption properties for these cyanoacrylates. See, for example, Robertson, et al., U.S. Pat. No. 3,722,599. Specifically, it has been reported that, when used as suture supplements or internally, polymeric residue of higher homologs of alkyl cyanoacrylate (e.g., n-butyl cyanoacrylate) has been observed by histological examination of the site of application as much as 12 months after application. Apparently, the cyanoacrylate polymeric residue is encased internally and, due to low biological absorption/resorption properties, remains at the site of application for prolonged periods of time. Such poor absorption/resorption properties are contra-indicative for their use as tissue adhesives.
SUMMARY OF THE INVENTION
This invention is drawn to methods for treating and/or protecting small superficial wounds by the application of alkyl cyanoacrylate adhesive to the surface of such wounds. Such small superficial wounds are characterized as superficial cuts or abrasions not penetrating through the dermal layer of the skin surface to the subcutaneous layer or tissue.
This invention is based, in part, on the discovery that application of cyanoacrylate adhesive to such small superficial wounds will not result in the undesirable prolonged internalization of polymeric adhesive. Without being limited to any theory, Applicants believe that such internalization of the polymeric residue does not occur because any polymeric residue entrapped within the epidermal and/or dermal layer will be shed as part of the normal shedding of these layers.
Moreover, contrary to typical prior art application methods, Applicants have found that by limiting application to such superficial cuts and abrasions, the cyanoacrylate adhesive can be applied under non-sterile conditions typically employed in consumer usage.
The methods of this invention involve applying a cyanoacrylate adhesive, particularly, n-butyl cyanoacrylate adhesive, onto the wound under non-sterile conditions and allowing the adhesive to polymerize.
In the case of cuts, the cyanoacrylate adhesive is generally applied between the separated skin defining the cut as well as over the cut. The cyanoacrylate adhesive is then allowed to polymerize so as to both bind the separated skin sections and form a polymer layer over the cut. In addition to serving as a protective layer, the polymer layer also serves to promote healing and to retard infection of the cut.
In the case of abrasions, the cyanoacrylate adhesive is generally applied over the abrasion. The cyanoacrylate adhesive is allowed to polymerize so as to form a polymer layer over the abrasion. The polymer layer serves to act as a protective layer which prevents further aggravation to the abrasion while also promoting healing and retarding infection of the abrasion.
Accordingly, in one of its method aspects, this invention is directed to a method for treating and/or protecting non-suturable superficial wounds which comprises:
applying to the surface of a non-suturable wound, in a non-sterile environment, a sufficient amount of a cyanoacrylate adhesive so as to cover the entire wound area wherein the wound is characterized as superficial cuts and/or abrasions which do not penetrate through the dermal layer of the skin surface to the subcutaneous layer; and
polymerizing the cyanoacrylate adhesive so as to join separated skin sections and/or to form an adhesive 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 alkyl of 2 to 10 carbon atoms.
Preferably R is alkyl of from 2 to 8 carbon atoms and more preferably alkyl of from 4 to 8 carbon atoms. Most preferably, R is either n-butyl or octyl.
In another of its method aspects, this invention is directed to a method for treating and/or protecting superficial non-suturable cuts which method comprises:
applying to the surface of a non-suturable cut in a non-sterile environment, a sufficient amount of n-butyl cyanoacrylate adhesive to cover the entire cut area wherein said cut is characterized as a superficial cut which does not penetrate through the dermal layer of the skin surface to the subcutaneous layer; and
polymerizing the cyanoacrylate adhesive so as to join separated skin sections and to form an adhesive coating which adheres to the area where the adhesive was applied
wherein, in monomeric form, the n-butyl cyanoacrylate adhesive is represented by the formula:
In a preferred embodiment, the cyanoacrylate is applied at least about 0.02 milliliter (ml), more preferably from about 0.02 to about 0.2 ml, and still more preferably from about 0.02 to about 0.1 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 about 2 to about 3000 centipoise at 20° C. More preferably, the cyanoacrylate adhesive is in monomeric form and has a viscosity of from about 2 to about 100 centipoise at 20° C.
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.
Preferably, R is an alkyl group of from 2-8 carbon atoms including ethyl, n-propyl, iso-propyl, n-butyl, iso-butyl, sec-butyl, n-pentyl, iso-pentyl, n-hexyl, iso-hexyl, 2-ethyl-hexyl, n-heptyl, and octyl. More preferably, R is butyl or octyl and most preferably, R is n-butyl.
These cyanoacrylate adhesives are known in the art and are described in, for example, U.S. Pat. Nos. 3,527,224; 3,591,676; 3,667,472; 3,995,641; 4,035,334; and 4,650,826 the disclosures of each are incorporated herein by reference in their entirety.
Preferred cyanoacrylate adhesives for use in this invention are n-butyl-2-cyanoacrylate and octyl-2-cyanoacrylate.
The cyanoacrylate adhesives described herein rapidly polymerize in the presence of water
Barley Leonard V.
Barley Linda M.
Renfrow J. Royce
Tighe Patrick J.
Burns Doane , Swecker, Mathis LLP
Levy Neil S.
MedLogic Global Corporation
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