Surgery: splint – brace – or bandage – Bandage structure – Retainers for wound dressings
Reexamination Certificate
1997-07-14
2001-07-10
Lewis, Kim M. (Department: 3761)
Surgery: splint, brace, or bandage
Bandage structure
Retainers for wound dressings
C602S059000
Reexamination Certificate
active
06258051
ABSTRACT:
BACKGROUND OF THE INVENTION
(a) Field of the Invention
This invention relates to wound dressings and wound bandages and more particularly, but not by way of limitation, to a disposable wound dressing and support unit having a wrap for holding a gauze pad or the like in place on top of a wound.
(b) Discussion of Prior Art
Because of the complexity of wound healing, the function of a wound dressing may be integral to the success of that process. Wound dressings function as:
a. a protective barrier from outside sources of irritation.
b. provide for mechanical support to the fragile wound surface.
c. serve to form an occlusive barrier to provide an optimal environment for certain wound types.
d. function to absorb wound byproducts that tend to accumulate and complicate healing.
e. act as an agent for wound debridement which acts to clean and prepare a wound bed for healing.
f. may have value as an acceptable camouflage for unsightly wound appearances.
The wound dressing is most often secured in place by the application of an adhesive to the skin. This seemingly simple and universal method of dressing fixation actually has limited applicability accompanied with a significant list of inadequacies, problems and patient dissatisfactions:
a. difficulty with conforming to some anatomic locations and contours, particularly in active body locations.
b. an increasing incidence of adhesive allergies resulting in blister formation, rashes, weeping wounds, scars, and permanent pigmentation problems.
c. inability to adhere in areas of raw, open wounds, or wounds with vulnerable scab formation.
d. lack of satisfactory adherence in hair bearing areas or areas of hypersensitivity.
e. pain associated with adhesive removal in hair bearing areas or areas of hypersensitivity.
f. adhesive system is not reusable when loosened by movement or moisture, thus necessitating reapplication.
g. lack of usefulness in wet to dry dressing situations. Due to the moist dressing, adhesives will not hold the dressings in place, making the wet to dry concept totally ineffective.
h. possibly the most important of issues is that a wound dressing, if not properly chosen, can significantly retard and limit wound healing.
i. adhesives used will stick to protective gloves now used by all handlers of wound products, often tearing the gloves and making them ineffective as a protective barrier.
The advent of AIDS and other serious infectious and contagious diseases has changed the thinking and application of traditional wound dressings. The matter of exposure applies to all parties involved in the care of a patient such as the health care provider administering the care, the patient and the individual removing the wound dressing. The subject invention addresses this acute problem.
Also, traditional wound dressings are applied with various tapes, elastic wraps or gauze wraps. These dressing wraps have intrinsic negative aspects as compared to the subject wound dressing and support unit described by virtue of:
a. restricted areas of usefulness in terms of adhesives. Adhesives also cannot easily be “readjusted”.
b. wraps produce significant bulk of material and that bulk also reduces the gas exchanged from the wound surface.
c. wraps obscure the nature and quantity of wound drainage.
d. wraps require some dexterity and finesse by the patient, which at times is not possible or at least discourages the patient from getting involved in his or her own care. This may lead to other individuals having to assist or take over care which increases the expense.
e. wraps often require a secondary means of fixation which thereby complicates the dressing change process.
f. wraps lead to waste of materials or increased production of biohazardous materials.
Heretofore there have been a variety of different types of wound dressings using adhesives and stretchable wraps such as described in the following patents.
U.S. Pat. No. 4,732,146 to Fasline et al. discloses a surgical wound dressing device having a frame with an opening for receiving different types of wound dressings. A dressing is held in place by straps attached to one side of the frame with one end of the straps including releasable Velcro fasteners.
U.S. Pat. No. 4,917,112 to Kalt describes a bandage having an opening with the opening covered with a transparent membrane. The membrane is designed to allow air and vapors to permeate outward from the wound and prevent contaminants from entering in the opposite direction.
In U.S. Pat. No. 4,909,243 to Frank et al., a two piece wound dressing is shown having an adhesive layer on one side of a baseplate with an opening in the baseplate to expose the wound and the epithelium area around the wound. A second adhesive layer on one side of a wound pad secures a wound dressing above the opening in the baseplate.
U.S. Pat. No. 4,907,579 to Kum, U.S. Pat. No. 5,167,613 to Karami et al., and U.S. Pat. No. 3,779,242 to McCullough disclosed different types of adhesive bandages for providing open areas to wounds to enhance healing. In U.S. Pat. No. 5,036,838 to Sherman, a foam plastic orthopedic fabric is described having a Velcro tab at one end of the fabric.
In U.S. Pat. No. 4,470,410 to Elliott a stretchable sleeve is shown with Velcro fasteners at the ends of the sleeve. The sleeve includes a central opening with a releasable flap for retaining an intravenous tube or the like.
U.S. Pat. Nos. 4,709,695 to Kohn et al., 4,399,816 to Spangler, 5,086,763 to Hathman, and 4,926,883 to Strock all describe different types of wound surrounding dressings and bandages. Also U.S. Pat. Nos. 4,190,054 to Brennan and 4,658,811 to Beaird disclose stretchable bandages having loop and hook type attachment ends for encircling the head of a patient.
In U.S. Pat. No. 5,456,660 to the subject inventors, a wound dressing support device is described for holding a variety of standard gauze pads in place on top of an open wound. The device includes an elongated unidirectional wrap with a window opening therethrough. Around the sides of the window is a non-adhesive fastener for releasably engaging a portion of the sides of the gauze pad.
None of these prior art patents disclose the unique structure and advantages of the subject invention as described herein when addressing the need of a disposable wound dressing and support unit in combination.
SUMMARY OF THE INVENTION
In view of the foregoing, it is an object of the present invention to provide a disposable wound dressing and support unit which is easy to apply and holds a variety of standard cotton gauze pads in place on top of a wound. The unit uses a bidirectional material which prevents slippage either up or down. However, the material allows readjustment by virtue of its unique closure system without adhesives.
Another object of the invention is to provide a disposable wound dressing and support unit that eliminates the need of adhesive tape which causes pain during removal, possible allergic reactions, and flimsy application due to hair, moisture and wound complications. Adhesives also do not allow for readjustment of tension on the wound dressing.
Still another object of the subject wound dressing and support unit is the wrap does not include a window opening therethrough or the unit includes a window frame with window opening. The window opening covered with a transparent cover for viewing the wound or viewing a sterile gauze pad covering the wound. There are medical situations in which the presence of a window opening through a support unit is either not indicated or not desired. Further, the size of the wound may be so large that the presence of a window opening in the wrap will compromise the integrity and function of the wound dressing and support unit. Also, there are situations when a physician wishes to treat a wound in an occlusive fashion. In this technique, evaporation through a window opening will dry out the wound, thus upsetting the purpose of an occlusive dressing, i.e. to keep the wound moist and air tight.
A further object of the invention is to serve only as a protective device and thus, the presence
Reich Marshall P.
Shesol Barry F.
Crabtree Edwin H.
Lewis Kim M.
Margolis Donald W.
No Mulligens, LLC
Pizarro Ramon L.
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