Elastic adhesive wound dressing for control of bleeding and...

Surgery: splint – brace – or bandage – Bandage structure

Reexamination Certificate

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C602S053000

Reexamination Certificate

active

06573419

ABSTRACT:

FIELD AND BACKGROUND OF THE INVENTION
The present invention relates to a wound dressing effective in rapidly controlling bleeding from a wound and, more particularly, to a wound dressing constructed and packaged such that the wound may be dressed using one hand.
Compression wound dressings: Bleeding control is a major consideration in the emergency treatment of acute trauma. Rapid and effective application of compression, at the scene of the traumatic incident until arrival at a medical facility, leads to decreased loss of blood from wounds and improves the chances of survival of the victim(s) (5, 6).
Traditional methods of bleeding control include direct compression, applied over the wound surface, usually employing an absorbent layer (4), and the tourniquet, tightly applied proximally to the wound (1). Direct compression is often effective in controlling bleeding, achieving high local pressures. Direct compression, however, is impractical in many emergency situations due to the need for continuous application by emergency care providers, thus neutralizing the care provider, denying performance of any other tasks. Direct compression cannot sustain the required constant local pressure, resulting in an increased tendency of the absorbent dressings to become saturated with blood (5). In addition, heavy direct compression may aggravate damage to other wounded tissues, such as fractures, and is inconvenient to apply over irregularly shaped or sensitive body parts.
The tourniquet, consisting of an elastic material bound tightly around the wounded body part, proximally to the wound, is applied with sufficient constricting force to cause ischemia distally to the site of application. This highly effective and widely used method of bleeding control may be left unattended, however, the induced ischemia is both extremely painful to the victim and commonly the cause of soft tissue and neurological damage to the distal body parts (1-3). Prevention of these undesired effects of tourniquet application is achieved by relieving the pressure at designated intervals, compromising the effectiveness and requiring additional attention by emergency care providers.
Elastic compression bandages: Elastic bandages, applied directly over the wound surface, are capable of providing significant compression and may be used in wound dressings. Elastic bandages are typically constructed of an elastomeric material, or a composite of elastic and non-elastic materials, which may be extended to provide constriction of the underlying surface. However, these fabric wraps, being non-adhesive, tend to shift with motion, compromising their comfort and compression capabilities, and therefore need to be fastened or bonded to an adhesive. Such wraps also lack absorbent qualities.
U.S. Pat. Nos. 3,575,782 and 4,984,584 to Hansen, and U.S. Pat. No. 4,699,133 to Schafer describe elastomeric, self-adhering compression bandages capable of achieving effective compression forces when applied over a dressed wound, but lacking absorbent properties.
Absorbent elastic wraps have been employed in compression bandages. U.S. Pat. No. 4,707,398 to Boggs, U.S. Pat. No. 4,720,415 to Vander Weilen, U.S. Pat. No. 5,230,701 to Meyer, and U.S. Pat. No. 4,957,795 to Reidel employ absorbent, elastic bandages which afforded both compression and exudate retention. However, the materials employed are non-self-adherent, requiring fastening and are prone to slippage when saturated with fluid.
An absorbent compression bandage has been proposed in which an insulated core comprises the major source of pressure. The core is embedded in absorbent material which becomes saturated with blood during application, and the dressing surface fails to adequately cover the wound surface. Thus, bleeding continues, requiring additional wound covering.
Another bandage comprises a rubber foam cushion and a pressure plate joined to the bandage surface. This bandage requires significant effort to apply, and results in diffuse compression and insufficient bleeding control.
In another design, a molded piece of polystyrene foam is centrally placed along a bandage surface, providing pressure on the outer surface of the bandage while the inner surface over the wound forms the area of contact. The molded plastic plate causes the bandage to protrude from the body surface and is exposed to possible erroneous displacement. The vacant space between the body surface and core, or mold, creates a potential for accumulation of unnoticed extravasated blood, dirt or fluids.
These and other configurations are disclosed in U.S. Pat. Nos. 2,858,830; 3,490,448; 3,888,247; 3,927,665; 3,625,209; 3,421,502; 4,005,709; and 4,377,159, and in BE 00522994 and GB00487743.
U.S. Pat. No. 5,939,339 to Delmore et al. describes a porous, elastic, self-adherent bandage flexibly attached to an absorbent layer. The self-adhering elastic is produced from elastic or spandex yarns bonded between porous fibrous webs or fabric, or a web of elastomeric polyurethane fibers. The absorbent layer covers all but a small portion of the elastic bandage's width along a major portion of the bandage's length. Thus, when applied, most of the absorbent pad is not in direct contact with the wound surface, and little self-adhesive bandage surface remains exposed, disposing the bandage to slippage and poor compression with movement and continued bleeding. A portion of the end of the elastic adhesive bandage remain uncovered by the absorbent layer, however in the event of dressing a wound not requiring the entire length of the bandage, the adhesive layer must be peeled back from the absorbent layer, a cumbersome and time-consuming inconvenience, especially for latex-gloved emergency care providers attending to trauma victims. Furthermore, the proposed bandage does not allow placement of the absorbent pad in a perpendicular orientation to the elastic bandage, encumbering the effective dressing of certain wounds, for example, a large longitudinal wound of a cylindrical body part (e.g., a limb). Another disadvantage of the proposed bandage is that the elastic, self-adherent component is composed of porous, opaque materials, covered by an absorbent layer, both precluding any observation of the wounded body part, or of the dressing after deployment. As depicted in the drawings, the proposed bandage requires two-handed application, while one-handed deployment, conceivably by the wounded victim himself, may provide a significant advantage in instances of severe trauma.
There is thus a widely recognized need for, and it would be highly advantageous to have a wound dressing effective in bleeding control devoid of the above limitations.
SUMMARY OF THE INVENTION
According to one aspect of the present invention there is provided a compression dressing, comprising (a) a self-adhering elastic bandage strip being designed for exerting a compressive force when wrapped around a body part sufficient to hold the compression dressing in place for a period of time to provide a therapeutic effect to a wound; and (b) an absorbent pad being affixed to an inner side of a terminal portion or to a terminal end of the self-adhering elastic bandage strip.
According to another aspect of the present invention there is provided a method of preparation and packaging of the compression dressing to enable rapid application within conditions of limited space, the method comprising (a) rolling the self-adhesive elastic bandage strip without affording contact between self-adherent surfaces; and (b) affixing the absorbent pad to the inner side of terminal portion or terminal end of said self-adhering elastic bandage strip.
According to still another aspect of the present invention the method of preparation and packaging of the compression dressing to enable application without direct contact of an applicator's gloved fingers or hand with an adhesive area, the method comprising rolling and packaging the self-adhering elastic bandage strip with its adhesive surface on an inner, unexposed side of a rolled self-adhering elastic bandage strip.
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