Surgery: splint – brace – or bandage – Bandage structure – Skin laceration or wound cover
Reexamination Certificate
1999-05-13
2001-06-12
Brown, Michael A. (Department: 3764)
Surgery: splint, brace, or bandage
Bandage structure
Skin laceration or wound cover
C602S041000, C602S042000, C602S043000, C602S044000, C602S045000, C602S046000
Reexamination Certificate
active
06245960
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to materials and methods for assisting in the healing of avulsed, burned, or ablative wounds, and in particular, to materials and methods which prevent excessive cicatricial, keloid, or fibromatoid formation, reduce fluid loss and provide protection from infection.
The treatment of open wounds has been hampered by a number of factors. It is desirable, for example, that such open wounds be protected against both infection and fluid loss by covering the wounds with a dressing. Dressings of fibrous material may actually interfere with the healing of the wound by becoming incorporated with the scab or granulation tissue and thus necessitating later surgical removal from the wound. Dressings of synthetic film have been employed but may also interfere with the healing of the wound by causing excessive accumulation of fluid beneath the dressing and may further interfere with healing since the body may tend to reject the synthetic material.
An additional problem with the healing of a large area wound is that of excessive scarring during the healing process. Various attempts have been made to address some or all of these problems.
U.S. Pat. No. 4,725,279 discloses a bio-and blood compatible material for a thermal burn dressing. The material is a composite comprising a thin film of thermoplastic material, such as Silastic ® (Dow Corning), a knitted or woven layer, and a bonded layer of biological molecules to render the material bio-and blood compatible. It is disclosed that the material has a vapor transmission rate comparable to the human skin and that it is desirable that the wound site be closed as occlusively as possible without allowing liquid to accumulate between the wound surface and the material of this invention. To avoid this effect a variant embodiment provides for “pinholes” in the material such that the material remains 98% or better occlusive.
U.S. Pat. No. 4,838,253 discloses a liquid permeable dressing comprising one or more sheets of apertured material, such as cotton gauze, coated with a tacky silicone gel or a non-tacky silicone elastomer.
U.S. Pat. No. 5,395,305 discloses a wound-covering material comprising two layers: a first support layer which is in contact with the wound and which contains a water repelling substance and a second moisture permeation controlling layer which may be formed from steam permeable resin films made of silicone or polyurethane elastomers.
U.S. Pat. No. 2,693,438 discloses a non-adherent pliable film for a surgical dressing. The dressing film is formed from water-soluble polyvinyl alcohol mixed with a plasticizing agent and water. The film may be reinforced by embedding a textile material in the outer layer. It is specifically noted that the film will not irritate the lesion or become incorporated in the scab or granulation tissue formed therein.
U.S. Pat. No. 5,196,190 discloses a membrane suitable for wound dressing comprising a natural or synthetic polymer, a non-gellable polysaccharide and a cross-linking agent. The membranes may also contain water-loss control agents, emulsifying agents, plasticizers, or an internal reinforcing material.
U.S. Pat. No. 3,803,300 discloses an ointment foil for application to skin. The ointment foil is prepared by drying an oil-in-water emulsion of ointment ingredients to a moisture content of 1% to 15%.
U.S. Pat. No. 3,867,520 discloses a medicated polyamino acid film for occlusive dressing therapy.
The limitations of the prior art are overcome by the present invention as described below.
SUMMARY OF THE INVENTION
The present invention is a combination process and device for improved rapid safe healing of large areas of avulsed or burned tissue which prevents excessive cicatricial, keloid or fibromatoid formation, greatly reduces fluid loss, and increases protection from infection.
An elastomer matrix; i.e., a thin sheet of elastomer with a plurality of fenestrations, is placed on the wound and a bath of oil, preferably soybean oil, in turn covers the fenestrated elastomer matrix. The elastomer is preferably medical grade Silastic®, available from Dow Corning. The soybean oil bath is provided by a flexible sealed capsule of thin elastomer, preferably Silastic® filled with soybean oil. The soybean oil bath overlaps the wound margin periphera by one centimeter or more. The thin capsule walls allow the soybean oil to slowly percolate through the walls that are semi-permeable to the soybean oil.
Enhanced granulation tissue formation is promoted by encapsulation of the wound with the elastomer matrix. As healing proceeds, granulation tissue engulfs the elastomer matrix while the matrix integrity and flexible rigidity acts to prevent drawing of the tissue and thereby reduces scarring.
In addition to reduced skin tissue scarring and more rapid healing, the present invention has the advantage of improved antisepsis due both to the barrier of the sterile soybean oil bath and the barrier of the elastomer matrix. In the preferred embodiment, the matrix presents a barrier of approximately half of its area (the remaining area being the fenestrations which do not of course provide a barrier).
The combination of the elastomer matrix and the soybean oil bath also acts to reduce loss of body fluids, which is significant to large burn surface areas, while allowing the wound to be inspected and cleaned as necessary. The elastomer matrix encourages the generation of granulation tissue since the elastomer matrix appears to the body as a foreign object that the body tries to reject.
The present invention is applicable to large avulsed, burned, ablative or disfiguring traumatic wounds. The invention is also applicable to tissue augmentation for tissue volume loss; e.g., pseudotosis.
It is therefore an object of the present invention to provide for an elastomer matrix with fenestrations allowing the penetration of granulation tissue through the fenestrations so as to cover the matrix as the wound heals.
It is a further object of the present invention to provide for the addition of an oil bath to further protect the wound during the healing process.
These and other objects and advantages of the present invention will be apparent from a consideration of the following detailed description of the preferred embodiments in conjunction with the appended drawings as described following.
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Board of Trustees of the University of Arkansas
Brown Michael A.
Cox, Jr. Ray F.
Hamilton Lalita M.
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