Gel dressing

Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Web – sheet or filament bases; compositions of bandages; or...

Reexamination Certificate

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Details

C424S445000, C424S447000, C424S448000, C514S944000, C602S041000, C602S048000, C602S057000, C602S061000, C602S062000, C602S079000

Reexamination Certificate

active

06592889

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention is broadly concerned with improved composite bandages for use in the treatment of fungal-infected toe nails or as a general wound dressing, wherein the bandages include a relatively stiff base with a preformed, gel-receiving recess therein together with a strippable flexible adhesive web applied over the base and gel; in use, the web is removed along with the gel and applied to form a long term bandage which promotes healing. In preferred forms, the gel includes substantial quantities of water and humectant, which enhances the healing effect.
2. Description of the Prior Art
Bandages and wraps of various types have been used by mankind for thousands of years. These have been used to cover wounds of all kinds and to provide padding and protection for inflamed tissues, for example. The goal of such uses is to prevent or ameliorate infection, and to promote rapid healing while providing a measure of pain relief.
Simple cotton or felt-type bandages have long been used, but these are at best crude expedients. In more recent times it has been proposed to provide therapy wraps, compresses and bandages which make use of gel materials. For example, U.S. Pat. No. 4,671,267 describes gel-based therapy wraps useful for treating wounds, injured skin or for orthopedic purposes. Indeed, gels in accordance with the '267 patent (commercialized under the designation Elastogel by Southwest Technologies, Inc. of Kansas City, Mo.) have proven to be particularly effective as wound and bum treatment agents. Additional gel materials are described in U.S. Pat. Nos. 4,055,188, 4,092,982 and 4,243,041.
While such gel-type bandages and the like are highly successful, in many instances rather complex wraps or attachment devices need to be provided in order to hold the gel in proper contact with a treatment site. Further, manufacturing constraints have made it difficult to provide, on an economical basis, bandage products having the otherwise desirable gel materials as a part thereof.
SUMMARY OF THE INVENTION
The present invention overcomes the problems outlined above and provides greatly improved bandage products useful for many purposes. The composite bandages of the invention broadly include base having a preformed pocket or recess therein which receives a humectant-containing gel, together with a flexible adhesive-coated web applied over the base and gel. The web is strippable from the base to give a bandage which can be applied to the skin, with the gel adhering to the web.
In preferred forms the base is formed of a shape-retaining, somewhat flexible synthetic resin material such as polystyrene, polyester or polycarbonate. During initial manufacturing steps the base material is cut to size and thermoformed to give the desired gel-receiving recess. In order to facilitate stripping of the web, the base may have a release agent (i.e., silicone-based) on the face thereof contacted by the web, either by surface coating or impregnation of the base material. The flexible web is usually fabricated from any one of a number of readily available adhesive tapes used for medical purposes.
The preferred gel contains a synthetic resin matrix with substantial quantities of water and humectant entrapped therein. Advantageously, gels described in U.S. Pat. No. 4,671,267 (which is incorporated by reference herein) are used in the bandages of the invention. Such gels can be readily cast in appropriate shapes and sizes, and provide a marked healing effect on a variety of wounds and the like. Moreover, it has been discovered that these gels, particularly when used in the bandages of the invention, give unexpectedly superior results when used in the treatment of discolored or fungus-involved toe nails. In the past, toe nail treatments have involved removal of the nail to eliminate fungi, which is a painful and time-consuming regimen. However, through use of the gel materials and bandages of the invention, complete recovery in the form of fungi elimination and return to proper coloration is achieved simply by application of the gel directly on the toe nail in a covering wrap or bandage for a period of several days (e.g., from about 2-10 days is usually sufficient). The hydration and humectant treatment afforded by this technique is believed to be responsible for these remarkable results.
The composite bandages of the invention can be economically produced using simple stepwise production methods. In practice, the base synthetic resin is cut into “sheets” and preformed using vacuum-forming techniques; typically, a number of individual bases are produced simultaneously on one sheet. The formed sheet is then moved to a gel filling station, where the appropriate amount of gel precursor liquid is poured or injected into each base recess. The gel material is then allowed to cure within the recesses, forming flexible but self-sustaining gel bodies. Finally, an adhesive web is applied over each sheet so as to essentially cover the bases and to contact the respective gel bodies. The individual bases are then cut to size and shape. The completed composite bandages can then be packaged and sterilized.


REFERENCES:
patent: 3612265 (1971-10-01), Dickerson
patent: 3880159 (1975-04-01), Diamond
patent: 3971374 (1976-07-01), Wagner
patent: 4671267 (1987-06-01), Stout
patent: 4860736 (1989-08-01), Kaitz et al.
patent: 4917112 (1990-04-01), Kalt

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