Surgery: splint – brace – or bandage – Bandage structure – Skin laceration or wound cover
Reexamination Certificate
1999-09-23
2001-07-03
Page, Thurman K. (Department: 1615)
Surgery: splint, brace, or bandage
Bandage structure
Skin laceration or wound cover
C602S047000, C604S307000, C424S449000, C424S448000, C424S443000
Reexamination Certificate
active
06255552
ABSTRACT:
TECHNICAL FIELD
This invention relates to a wound dressing system for treating wounds. In one aspect, it relates to such a wound dressing system that prevents disturbance of wounds caused by dressing changes.
BACKGROUND OF THE INVENTION
The treatment of wounds with dressings involves a wide variety of situations and applications. A corresponding variety of different types of dressings are available for treating wounds. Dressings have been designed to contain various medicaments and solutions for either absorption into the wound or to wick or remove fluids from the wound area to maintain a proper moisture level at the wound. These dressings typically have some type of absorbent as part of the dressing. Occlusive dressings have been designed to include properties that protect a wound from outside elements, while yet maintain a proper moisture level at the wound and trap the tissue's natural healing fluids. Pressure dressings have been designed to keep pressure on a wound. Body tissues encounter a wide variety of wounds, for example, abrasions, lesions, skin grafts, burns, and pressure sores. Each type of wound undergoes several stages of healing and may require different modes of treatment depending on the stage of healing. Thus, the treatment of a wound involves the selection of a dressing based on the particular type of wound and the various healing stages that are contemplated. Considerations such as size, location and extent of infection of the wound also play a role in selecting a dressing.
However, regardless of the various considerations, the treatment of wounds necessarily involves the periodic changing of the dressings being used to treat the wound. Dressings must be repeatedly removed and replaced for various reasons, for example, to irrigate and cleanse the wound, to reapply medicament, to replace a saturated or soiled dressing, to prevent incorporation of the dressing into the wound, or to merely inspect the wound.
The problem attendant with changing dressings is that the wound is often disturbed during the removal of the dressings. This disturbance of the wound is usually caused when the dressing has wholly or partially adhered to the wound, whereby removal of the dressing destroys any healing that has already occurred, for example, the formation of granulation tissue or the buildup of fibrin which helps clot the blood. Also, and equally as important, removal of an adhered dressing causes great pain to the patient, especially when the wound is at a healing stage where new nerve endings are forming in the wound. The high potential for such wound damage and pain requires extensive nursing time to remove and replace dressings with various techniques to help reduce the wound damage and pain.
The term “adherence” has not been clearly defined in the field of tissue dressings. “Adherence” of a dressing to a wound is typically narrowly defined as when exudate from a wound has dried to and bound with some part of a dressing such as an absorbent. With this narrow definition of adherence in mind, “non-adherent” materials are claimed to have been developed which can be interposed between a wound and a dressing.
Such interposing of “non-adherent” materials has been carried out by two methods. The first method involves a first step of placing a layer of “non-adherent” material over the wound and a second step of placing a separate dressing over the “non-adherent” material. U.S. Pat. No. 4,638,796 to Sims discloses such a method. However, this method involves two application steps and two separate materials to be applied on a wound. The need for sterile dressings and application procedures makes such a two step method appreciably more cumbersome than applying a single dressing. There is also a substantial risk that because of a busy hospital, untrained care providers, or some other mistake or circumstance, the dressing will be applied without first applying the layer of “non-adherent” material. Such an omission could very likely result in the dressing “adhering” to the wound. Another problem with this method is that because of the nature of the “non-adherent” materials, they can be difficult to keep in place while applying the separate dressing. Sometimes the non-adherent materials must be secured in place over the wound before the separate dressing can be applied.
An additional drawback of placing a layer of non-adherent material on the wound and then a dressing over the wound is that, with some types of wounds and some types of dressings, a single layer of non-adherent material will not sufficiently prevent bonding between the wound and the dressing. Applying more than one layer of non-adherent material becomes a cumbersome process in the typical wound care situation. For example, hydrocolloid dressings, such as DuoDERM® made by Convatec®, have a tendency to become very sticky and viscous when in contact with wound exudate. A single layer non-adherent material often does not adequately prevent the hydrocolloid material from working or permeating through the interstices of the non-adherent material and bonding to the wound. If the mesh of the non-adherent material is too tight, liquid may pool at the wound, and be unable to properly pass through the non-adherent material. This creates a potential for maceration of the wound.
The second method of interposing a “non-adherent” material between a wound and dressing involves the use of an integral dressing that has one or more layers of “non-adherent” material laminated or joined to it. This type of dressing is supposed to prevent the wound from “adhering” to the dressing in the narrow sense of the term “adherence”, however, redressing a wound with these dressings involves removing the entire dressing, including the “non-adherent” material. U.S. Pat. No. 4,667,665 to Blanco et al. discloses one such dressing: an integral closed dressing with an outer casing that encloses layers of an absorbent and is sealed at its peripheral edges. One side of the dressing casing is two layers of “non-adherent” material. It has been found that removal of these types of dressings without causing pain involves soaking the dressings with a saline solution and then teasing the dressings off of the wound. This process involves intensive nursing time to set up a sterile basin with solution, soak the dressings and then painstakingly tease off the dressings. The soaked dressing presents a disposal problem in that the dressing is dripping wet and often tears apart.
The process of removing these internal dressings can appreciably disturb wounds so as to cause pain and delay healing of the patient. Further, removal of these dressings often requires a qualified care provider to “tease” the dressing off of the wound to minimize disturbance of the wound. As noted above, such teasing and manipulation of these dressings entails additional nursing time as well as additional pain and anxiety that the patient must endure during a dressing change. Sometimes these dressings are torn apart in an effort to prevent removal of a part of the dressing that has adhered to a wound. Such tearing at the wound site is cumbersome, time consuming and often creates a mess as the different layers of the dressings, especially the absorbent, tear apart.
User instructions for the commercial embodiment of the invention disclosed in the Blanco et al. patent disclose an alternate method of removal which requires soaking the dressing, then cutting along its outer edges while the dressing is wet with saline and then peeling away the top layers to leave a layer of “non-adherent” on the wound. Cutting the dressing requires the delicate use of a cutting instrument at the surface of the patient's skin. Again, such a cumbersome task requires intensive nursing time to delicately cut around the dressing edge without accidentally contacting the patient's skin or sensitive wound with the cutting instrument.
A drawback of the so-called “non-adherent” materials is that, although they are “non-adherent” relative to the dressings with which they are used, they are not completely non-adherent
Cummings Gary Wayne
Cummings Robert
Chauza Roger N.
Ghali Isis
Howison, Chauza, Handley & Arnott, LLP
Page Thurman K.
Patent Holdings LLC
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