Elastic bandage

Surgery: splint – brace – or bandage – Bandage structure – Support covering

Reexamination Certificate

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Details

C602S041000, C602S045000, C602S076000

Reexamination Certificate

active

06663584

ABSTRACT:

BACKGROUND OF THE INVENTION
The present invention relates generally to a wound dressing, and more particularly, to a wound dressing that is a multi-layer, elastic bandage that may be compressively wrapped around a wound and is capable of absorbing fluids and wound exudate while preventing the absorption of external liquids through the bandage. When permeation of moisture vapor is desired, proper selection of the materials can maintain the liquid barrier properties while allowing breathability of moisture vapor.
In the field of medicine, wrappings or bandages have long been used to prevent injury, in addition to providing for protection against re-injury. For example, limbs are wrapped to prevent injury or re-injury to skin, tendons, muscles and/or ligaments as well as to provide support. Similarly, adherent articles, such as bandages or adhesive tapes are commonly used to cover wounds, cuts, blisters, and the like. Such adherent articles typically include an adhesive material that is applied to or used in conjunction with a substrate material. For example, to use an adherent article a portion of the substrate material is positioned over the wound and an adhesive portion either previously conjoined to the substrate or placed over the substrate is adhered to the surrounding skin. The adherence of the substrate material to the skin allows the adherent article to be tightly fitted over the wound to protect the wound from infection.
A widely acceptable form of treatment for chronic leg ulcers is compression therapy. Wrapping products are typically employed so as to apply a pressure of less than about 3 pounds per square inch to the area wrapped. Lower pressures such as, for example, about 1 psi are desirable. In contrast, wraps which exert substantial pressure can cause circulation problems. Further, if the material is folded or creased while being applied, the bandage might provide uneven support or have high tension areas. This ultimately could cause circulation problems in the user's leg. There is often a need to combine compression therapy with the use of an absorbent article. Problems associated with absorbent articles relate to positioning and securing them over a wound bed. Further, when an absorbent article is used, it often must be forcibly torn away from the skin to break the adhesive bond of the substrate with the skin. This frequently results in substantial pain to the user and possible maceration of the wound itself.
DEFINITIONS
The term “elastic” is used herein to mean any material which, upon application of a biasing force, is stretchable, that is, elongatable at least about 60 percent (i.e., to a stretched, biased length which is at least about 160 percent of its relaxed unbiased length), and which, will recover at least 55 percent of its elongation upon release of the stretching, elongating force. A hypothetical example would be a one (1) inch sample of a material which is elongatable to at least 1.60 inches and which, upon being elongated to 1.60 inches and released, will recover to a length of not more than 1.27 inches. Many elastic materials may be elongated by much more than 60 percent (i.e., much more than 160 percent of their relaxed length), for example, elongated 100 percent or more, and many of these will recover to substantially their initial relaxed length, for example, to within 105 percent of their original relaxed length, upon release of the stretching force.
The term “inelastic” or “nonelastic” as used herein refers to any material which does not fall within the definition of “elastic,” above.
As used herein the term “extensible” means elongatable or stretchable in at least one direction.
The term “machine direction” as used herein refers to the planar dimension of a nonwoven fibrous web which is in the direction of travel of the forming surface onto which fibers are deposited during formation of the web.
The term “cross-machine direction” as used herein refers to the planar dimension of a nonwoven fibrous web which is in the direction that is perpendicular to the machine direction defined above.
The term “z-direction” as used herein refers to the thickness direction of a sheet of material, that is, the direction perpendicular to the plane of the length and width dimensions.
As used herein, the term “disposable” is not limited to single use articles but also refers to articles that can be discarded if they become soiled or otherwise unusable after only a few uses.
The term “composite elastic material” as used herein refers to an elastic material which may be a multi-component material or a multilayer material. For example, a multilayer material may have at least one elastic layer joined to at least one gatherable layer so that the gatherable layer is gathered between the locations where it is joined to the elastic layer. Such a multilayer composite elastic material may be stretched to the extent that the nonelastic material gathered between the bond locations allows the elastic material to elongate. This type of multilayer composite elastic material is disclosed, for example, by U.S. Pat. No. 4,720,415 to Vander Wielen et al., issued Jan. 19, 1988, and U.S. Pat. No. 6,096,668 to Abuto et al., issued Aug. 1, 2001, and a process for making the same is disclosed, for example, by U.S. Pat. No. 5,964,973 to Heath et al., issued Oct. 12, 1999, all of which are hereby incorporated by reference.
The term “stretch-to-stop” as used herein refers to a ratio determined from the difference between the unextended dimension of a composite elastic material and the maximum extended dimension of a composite elastic material upon the application of a specified tensioning force and dividing that difference by the unextended dimension of the composite elastic material. If the stretch-to-stop is expressed in percent, this ratio is multiplied by 100. For example, a composite elastic material having an unextended length of 5 inches and a maximum extended length of 10 inches upon applying a force of 2000 grams has a stretch-to-stop (at 2000 grams) of 100 percent.
The term “meltspun” as used herein refers to a nonwoven web of filaments or fibers, which are formed by extruding a molten thermoplastic material, or coextruding more than one molten thermoplastic material, as filaments or fibers from a plurality of fine, usually circular, capillaries in a spinneret with the diameter of the extruded filaments or fibers. Meltspun fabrics include, but are not limited to, spunbonded fabrics and meltblown fabrics and are characterized as having thermal bonding junctions throughout the fabric.
As used herein, the terms “nonwoven” and “nonwoven web” mean a web having a structure of individual fibers or threads which are interlaid, but not in an identifiable, repeating manner. Nonwoven webs have been, in the past, formed by a variety of processes such as, for example, meltblowing processes, spunbonding processes and bonded carded web processes.
As used herein, the term “autogenous bonding” means bonding provided by fusion and/or self-adhesion of fibers and/or filaments without an applied external adhesive or bonding agent. Autogenous bonding may be provided by contact between fibers and/or filaments while at least a portion of the fibers and/or filaments are semi-molten or tacky. Autogenous bonding may also be provided by blending a tackifying resin with thermoplastic polymers used to form fibers and/or filaments. Fibers and/or filaments formed from such a blend can be adapted to self-bond with or without the application of pressure and/or heat. Solvents may also be used to cause fusion of fibers and filaments which remains after the solvent is removed.
As used herein, the terms “meltblown”, “meltblown fibers”, and “meltblown filaments” mean fibers formed by extruding a molten thermoplastic material through a plurality of fine, usually circular, die capillaries as molten threads or filaments into a high velocity gas (e.g. air) stream which attenuates the filaments of molten thermoplastic material to reduce their diameter, which may be to microfiber diameter. Thereafter, the meltblown

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