Surgery – Body protecting or restraining devices for patients or infants – Drapes
Reexamination Certificate
1999-09-20
2004-06-01
Brown, Michael A. (Department: 3764)
Surgery
Body protecting or restraining devices for patients or infants
Drapes
C128S850000
Reexamination Certificate
active
06742522
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to the field of surgical incise drapes. More particularly, the present invention pertains to surgical incise drapes having liners that provide tension for these drapes during application.
BACKGROUND OF THE INVENTION
Many of today's surgical procedures involve the use of a surgical incise drape. The incise material is usually a clear polymeric film with an adhesive on one side that is covered with a release liner. Two suppliers of incise materials are Minnesota Mining and Manufacturing Company, St. Paul, Minn., and T. J. Smith and Nephew Ltd. Examples of incise material can be found in U.S. Pat. Nos. 4,310,509; 4,323,557; 4,452,845; Re. 31,886; and Re. 31,887.
Typically, incise material is used in connection with towels or surgical drapes to maintain the surgical area as clean and sterile as possible to help reduce the risk of infection. Once the surgical area of the patient has been cleaned and treated with an antimicrobial, the surgical site is squared-off by the use of sterile towels and a surgical drape that has a fenestration (i.e., a specifically designed shape and opening formed therein) of a size that is larger than the expected size of the incision. An incise material is then used to cover all or a portion of the patient's skin left exposed by the towels or the fenestration in the surgical drape or main sheet.
One purpose for using the incise material is to help reduce the migration of germs and bacteria into the incision site. This reduction is needed, because despite the cleansing of the skin, the pores still contain additional germs and bacteria, which can migrate to the surface as the skin is moved and worked during the course of the surgical procedure. By covering the skin with incise material, it has been found that a lower incidence of surgical site contamination occurs.
Common practice is to take the sterile incise drape out of a disposable, protective bag (e.g., made from polyethylene), further remove any other protective coverings, and deliver it to the sterile field in an aseptic manner. For example, the protective coverings may be materials such as paper wraps for wrapping around the drape to allow the drape to be inserted into the disposable protective bag without tearing or wrinkling the drape in the packaging process. The use of multiple protective coverings result in added waste in the surgical area.
The surgical incise drape typically comes in sizes as small as 13×18 cm (5×7 inches) but are usually 40×30 cm (16×12 inches) up through 90×120 cm (36×48 inches) and larger. Conventional surgical incise drapes usually consist of an adhesive coated incise material covered by a one-piece coated paper release liner with equal dimensions as the film so that the adhesive is protected.
Typical practice is for two people to stand on opposite sides of the operating table, each within the sterile field with sterile gloved hands. One person grips a handle portion of the drape (a 10 to 15 cm film margin free of adhesive) while the other person takes the paper liner and pulls it way from the underside exposing the adhesive. The drape is then applied to the patient at the surgical site and subsequently smoothed out and pressed onto the patient with a sterile towel. With larger drapes, this might require three or more people.
Current incise drapes are usually large and cumbersome to apply to the patient without wrinkles and without the drape sticking to itself in the process. As described above, drape application usually requires two or three people, creating a drain on operating room personnel and contributing to rising hospital costs. Applying conventional incise drapes can be a frustrating experience, even for those skilled in the art of applying these drapes. The drape is flimsy (so as to be very conformable to the contours of the skin) with an aggressive pressure sensitive adhesive for adhesion to the skin. These two characteristics, when combined with the large size of many incise drapes, frequently results in the application of a wrinkled drape.
For proper functioning of a surgical incise drape, it is important that the incise drape be wrinkle-free after it is applied, especially directly at the incision point in order for the surgeon to be able to make a clean surgical incision. Wrinkles in the drape make it difficult for the surgeon to see through to the skin (translucency and visibility are important). Furthermore, if the incise drape includes wrinkles, the incise drape may not prevent bacteria on the skin from getting into the wound. Maintaining a sterile surface at the point of incision helps prevent surgical wound infections. Further, it is important that the incise drape be easily applied with as few steps as possible, and that waste resulting from use of the incise drape be minimized.
SUMMARY OF THE INVENTION
This invention provides a surgical incise drape that can be effectively and efficiently applied to a patient in wrinkle-free form so as to minimize the chance of infection, improve the visibility through the film as the drape is applied to a patient, and reduce the amount of waste resulting from the use of the drape.
A surgical incise drape in accordance with the present invention includes a flexible film having a major portion coated with an adhesive. The flexible film has a leading edge and a trailing edge. The drape further includes a film handle at the leading edge of the flexible film with the film handle being stiffer than the flexible film. Yet further, the drape includes a liner having a leading edge and a trailing edge corresponding to the leading edge and trailing edge of the flexible film. The liner includes a liner handle at the leading edge and the liner substantially covers the major portion of the flexible film coated with the adhesive. Either the liner handle or film handle is of a size for wrapping about at least a portion of the drape when the drape is in a folded configuration.
In one embodiment of the drape, either the liner handle or film handle is of a size for wrapping about the entire periphery of the drape when the drape is in the folded configuration. In another embodiment of the drape, the drape further includes a closure element attached to the liner handle or the film handle and extending for attachment to another portion of the drape when the drape is in the folded configuration. In yet another embodiment of the drape, the drape in the folded configuration is flattened such that the drape includes creases at respective opposing regions thereof.
In another embodiment of the drape, the liner is relatively stiff compared to the flexible film such that the liner and the film handle hold the flexible film in a wrinkle-free state when the liner is being removed from the major portion of the flexible film. For example, the liner may be a polyolefin liner having a thickness of at least about 50 microns and preferably at least about 75 microns. Further, for example, the liner may be a polyethylene liner, such as a medium density or high density polyethylene liner.
In another embodiment of the drape, the liner includes at least one tensioning strip at a position away from the leading edge of the liner so as to hold at least a portion of the flexible film lying between the film handle and the one or more tensioning strips in a wrinkle-free state when the liner is being removed from the major portion of the flexible film. For example, a tensioning strip may be at the trailing edge of the liner and/or at any position between the leading edge and trailing edge of the liner.
In another embodiment of the drape, the adhesive coating the major portion of the flexible film includes a first adhesive region proximate the leading edge of the flexible film and a second adhesive region at or near the trailing edge of the flexible film. A greater force is required to remove the liner from the second adhesive region relative to removing the liner from the first adhesive region.
Another surgical incise drape in accordance with the present invention in
Baker Dennis L.
Bruno John E.
Eull Patricia A.
Schlei Dietmar
Scholz Matthew T.
3M Innovative Properties Company
Brown Michael A.
Lambert Nancy M.
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