Surgery: splint – brace – or bandage – Bandage structure
Reexamination Certificate
2000-01-06
2003-01-28
Brown, Michael A. (Department: 3764)
Surgery: splint, brace, or bandage
Bandage structure
C602S003000
Reexamination Certificate
active
06512158
ABSTRACT:
TECHNICAL FIELD
The present invention relates generally to medical protective wraps and in particular to medical protective wraps made of liquid impermeable, flexible, polymeric material having watertight sealing cuffs which in combination provide a watertight barrier to protect wounds or surgical incisions from contamination due to dirt, microbes or infiltration of water during bathing without applying constricting pressure on tissue near the wound.
BACKGROUND OF THE INVENTION
After surgery or a serious injury a major concern of most patients is the ability to return to normal routines which include bathing or showering. This often presents a problem because the wound must be maintained in a sterile condition without contamination from water or dirt. In the past, many watertight dressings have been developed but these waterproof protective covers may also restrict movement of the involved body part. This restriction of movement may hinder progress of a rehabilitation program especially if waterproof protection is required for therapeutic sessions in a whirlpool.
Typical of the most common forms of protection from exposure to external water and dirt for an injured limb include bag-type structures. Some patents representative of this type of structure are as follows: U.S. Pat. No. 4,523,586 to Couri issued Jun. 18, 1985; U.S. Pat. No. 5,152,282 to Elphick et al issued Oct. 6, 1992; U.S. Pat. No. 5,395,302 to Botha et al issued on Mar. 7, 1995; and U.S. Pat. No. 5,720,712 to Joy et al issued Feb. 24, 1998. However, this type of covering presents several disadvantages. For instance, if the wounded area involves an arm then placement of a bag-type structure over the arm eliminates the use of the encased hand for participating in normal routines. In the case of a leg, the foot is virtually immobilized in the bag-type structure. Moreover, movement is difficult and dangerous because of the possibility of further injury due to the potential risk of slippage on the bag structure.
Additionally, several of the protective coverings currently available use elastic closures or some type of constriction on the peripheral edges of the wrap or bag to maintain a watertight seal. Examples of this type of closure are shown in U.S. Pat. No. 2,911,974 to Spence issued on Nov. 12, 1959 and Botha et al supra. It is believed that restrictive elastic closures may be counter-productive to healing because the additional pressure on the tissue beneath the elastic closure can cause a reduction of blood flow to the area thereby slowing the healing process.
Other types of protective wraps utilize a strip of adhesive tape or a tacky strip on the peripheral edges of the protective covering for protecting an injury or incision, such as that disclosed in U.S. Pat. No 1,707,515 to Evans issued on May 29, 1926. However, this type of adhesive strip can introduce a high level of discomfort to the patient when the cover or wrap is removed especially if the tape adheres to a patient's body hair. Furthermore, there may be seal leakage at particular sections that are stressed during body movement allowing water infiltration to the wound site.
Some protective covers may present difficulties in the application process, such as shown in Elphick et al and Botha et al supra. As a result, a patient cannot place and adjust the protective covering without the help of a second hand or another individual. Several wraps, currently available, require two hands to adjust and secure the wrap. As such, help may be required from a second party if the injury is on an arm or hand, especially if the covering needs to be held with one hand and tightened by another hand.
In the past, most protective coverings for wounds have included some type of absorbent material, with the thought that wicking away of bodily fluids aids in healing. But, there is considerable literature to indicate that a drying environment may slow healing time and also increase scar tissue formation due to forcing the migration of epidermal cells under a scab which has formed in a dry environment.
Accordingly, there is a need for protective wraps which are constructed of flexible, liquid impermeable materials, self-applying with one hand and providing a watertight barrier for bathing without causing restriction of blood flow to the site of injury over extended periods of use.
SUMMARY OF INVENTION
The present invention meets the aforementioned needs by providing improved, disposable, liquid impermeable flexible medical protective wraps for wounds that can be self-applied and adjusted by the user and can be worn for extended periods without restricting blood flow to the injury site.
For purposes of this invention, the terms and expressions below, appearing in the specifications and claims, are intended to have the following meanings”
“Wound” as used herein means a surgical incision, laceration or any other injury that needs to be protected by the present invention.
A primary object of the present invention is to provide a medical protective wrap for protecting a wound on a body part which comprises:
a) a sheet of liquid impermeable, stretchable, flexible polymeric film of a sufficient length to wrap around the body part at least once;
b) a first and second peripheral edge on opposing ends of the sheet;
c) a sealing cuff extending along the first and second peripheral edge, the sealing cuff having reduced stretchability relative to the sheet;
d) a first and second terminal edge on the sheet running transverse to the longitudinal axis of the first and second peripheral edge; and
e) at least one means for fastening on the first terminal edge and second terminal edge.
The means for fastening on the first terminal edge may be on both sides of the sheet thereby providing a means for fastening on the top side of the first terminal edge which may adhere to the body part. On the bottom side of the first terminal edge is a means for fastening which may adhere to the sheet at the position where the sheet has made one complete wrap around the body part. The means for fastening on the second terminal edge is secured to the sheet thereby providing a watertight seal along the second terminal edge.
A primary advantage of the present invention is that it provides a water-tight seal without elastic closures thereby avoiding reduced blood flow to the wound area. Additionally, the protective wrap is secured to the body part with a minimum of adhesive sites and does not rely exclusively on adhesive bonding directly to the body part for forming a water-tight barrier.
In one embodiment the sheet of liquid impermeable, stretchable, flexible polymeric film may be treated with an antimicrobial agent. This treatment may include impregnation of the polymeric film prior to forming the medical wrap of the present invention.
In another embodiment of the present invention it may be desirable to employ a low moisture vapor permeable, liquid impermeable polymeric film for fabrication of the medical wrap sheet. The low moisture vapor permeable, water impermeable polymeric film maintains a moist environment which is believed to be capable of accelerating wound healing but also allows for some evaporation of any excess water in the exudate from a wound thereby helps to prevent blisters from forming under the medical wrap.
Another advantage is that the protective wrap is non-reusable thereby eliminating concerns of disinfecting the medical wrap between applications.
The medical protective wrap can be applied to an injury or wound on a body part, the medical protective wrap comprising a liquid impermeable stretchable polymeric sheet of a sufficient length to wrap around the body part at least once, having sealing cuffs with reduced stretchability positioned along opposing first and second peripheral edges of the sheet, having first and second terminal edges running transverse to the longitudinal axis of the first and second peripheral edges, having a means of fastening to the body part on the top side of the first terminal edge and means for fastening to the sheet on the bottom side of the first terminal
Brown Michael A.
Ellis Howard M.
Hamilton Lalita M
Medwrap Corporation
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