Surgery – Body protecting or restraining devices for patients or infants – Drapes
Reexamination Certificate
1999-10-22
2001-10-09
Brown, Michael A. (Department: 3764)
Surgery
Body protecting or restraining devices for patients or infants
Drapes
C128S853000
Reexamination Certificate
active
06298855
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates generally to surgical drapes, and more particularly to surgical drapes suitable for spinal intervention procedures.
BACKGROUND OF THE INVENTION
Drapes are used during surgical procedures to create and maintain a sterile environment about the surgical site. Draping materials are selected to create and maintain an effective barrier that minimizes the passage of microorganisms between non-sterile and sterile areas. To be effective, a barrier material should be resistant to blood, aqueous fluid, and abrasion, as lint-free as possible, and drapable. When used during surgery, drapes prevent blood and other bodily fluids from contaminating the sterile field.
A variety of surgical drapes exist, but most share several common features. Most drapes are made of a water-repellent or water-impermeable material, or are coated with such a material, to prevent the passage of bodily fluids as well as contaminating microorganisms. Many of today's surgical drapes are made of disposable nonwoven fabrics, plastic film, or papers.
Surgical drapes will commonly have an opening or aperture (more commonly known in the medical field as a “fenestration”) through which the surgical procedure is performed. In certain procedures, more than one surgical site is used. In these more complex procedures, the patient must be draped using a plurality of drapes or must be re-draped between procedures.
An adhesive material may be attached to the periphery of the drape material about the fenestration so that the drape can be held in place around the surgical site and so that blood will not pass between the drape and the patient's body. The combination of the drape itself and the adhesive material around the perimeter of the aperture ensures a barrier between the surgical wound and the remainder of the body. Some drapes utilize incise materials which extend over the fenestration. The incise materials are typically transparent plastic films having an adhesive side which adheres to the surgical site of the patient. In such draping systems, the drape is secured to the patient by at least the incise material.
Electric cords and suction lines running along the patient are usually clamped or tied to the edges of the outer sheet on the surgical table. These cords or lines can become entangled, and when pulled may cause devices to fall to the floor and become unsterile. The clamps and ties are usually not versatile or strong enough to allow easy addition or removal of tubes and electrical lines. This results in delay in surgery while operating room personnel undo and re-affix clamps. Providing drapes that are suitable for use in surgical procedures adequate mechanisms to secure such cords and lines remains a concern of health care professionals.
To minimize the costs and risks associated with surgical procedures, it is desirable to provide a one-piece drape that is easy to apply, provides multiple surgical sites and adequate mechanisms for retention of cords and lines, and may be tailored for specific types of surgery.
SUMMARY OF THE INVENTION
In response to the foregoing problems and difficulties encountered by those of skill in the art, the present invention is directed toward a surgical drape for covering a patient during a surgical procedure. The drape includes a base sheet having an upper surface, a lower surface, a forward edge, and a rearward edge. The drape of the present invention further includes a primary fenestration that is formed in the base sheet through which a surgical procedure may be performed when the drape is covering a patient. In some embodiments, at least one secondary fenestration formed in the base sheet through which a second surgical procedure may be performed when the drape is covering a patient. In certain embodiments, two secondary fenestrations may be utilized.
A reinforcement panel may be disposed about the primary fenestration, and in some embodiments, about the secondary fenestrations. The reinforcement panel may be positioned on the upper surface of the base sheet and includes reinforcement fenestrations that are aligned with the primary fenestration and, if necessary, the secondary fenestrations.
An incise layer may also be provided, the incise layer being disposed over the primary and secondary fenestrations and disposed between the reinforcement panel and the base sheet. The incise layer includes an adhesive side that is adapted to adhere to the patient when the drape is covering the patient. In some procedures, particularly those procedures which take a long time, it is important that the incise layer be “breathable” by exhibiting high moisture vapor transmission rates. Thus, the adhesive side of the incise layer faces downwardly when the drape is positioned over the patient. Release layers may be provided on the adhesive side of the incise layer to permit easy handling and maintain sterility of the incise layer.
The drape of the present invention may be further adapted to be positionable over the patient so that the primary fenestration is disposed proximate to the spine of the patient, and the secondary fenestration is disposed proximate to the bone graft site of the patient. At least one pouch may further be provided, the pouch being releasably attachable to the upper surface of the drape.
The surgical drape of the present invention may be folded so that, as medical personnel apply the drape to the patient, the lower surface of the drape is on the exterior of the folded drape, and the release layer covering the primary fenestration is clearly visible and easily accessible by the medical personnel. In some embodiments, the release layer disposed over the incise layer of the primary fenestration is segmented so that a portion of the adhesive side of the incise layer may be exposed and applied to the patient. In such an embodiment, additional portions of the incise layer of the fenestration may be exposed and applied to the patient, if necessary.
Additionally, pouches may be provided which have an upper edge which are attached to the surgical drape, and a lower portion that is releasably adhered to the drape. Such a configuration permits electrical cords, suction lines and the like to be routed beneath the pouch and held securely in place.
Other objects, advantages and applications of the present invention will be made clear by the following detailed description of a preferred embodiment of the invention and the accompanying drawings wherein reference numerals refer to like or equivalent structures.
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Brown Michael A.
Garrison Scott B.
Kimberly--Clark Worldwide, Inc.
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