Surgery – Body protecting or restraining devices for patients or infants – Drapes
Reexamination Certificate
2000-02-01
2001-04-17
Brown, Michael A. (Department: 3764)
Surgery
Body protecting or restraining devices for patients or infants
Drapes
C128S852000
Reexamination Certificate
active
06216700
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to an improved surgical drape and surgical drape kit, and more particularly relates to a surgical drape suitable for use with positionable fasteners and to a surgical drape kit including positionable fasteners, allowing medical personnel greater flexibility in positioning and repositioning the drape and/or surgical tools during a medical procedure.
Various types of surgical drapes have been used to keep a surgical site on a patient sterile during a surgical procedure. Traditionally, surgical drapes were linen or woven cloth, and were sterilized after each use for reuse. More recently, disposable drapes have been introduced, in which nonwoven paper or fabric forms a substantial part of the drape. A reinforcement area is often placed around a fenestration opening or edge in disposable surgical drapes to provide structural strength and to absorb bodily fluids from a surgical site. Many disposable drapes include a number of layers of different materials for the drape area and reinforcement area, with each layer providing a different property to the drape. For example, spunbond fabrics, meltblown fabrics, and polymer films have been used as layers in disposable drapes.
Many different shapes of surgical drapes have been proposed, often depending upon the specific surgical procedure to be performed. For example, the shape of the drape was often specifically designed to fit around a specific surgical site on the body. In some cases, a fenestration opening was provided through a drape to allow medical personnel access to the surgical site, whereas the remaining sheet portion of the drape would cover the rest of the body and table. Often, several drapes were used in combination to cover a patient. In some cases, several rectangular drapes, often called universal drapes, were laid over the patient in a pattern providing an opening through which the medical personnel could access the surgical site while also covering the remainder of the patient's body and the table.
Various structures have been developed to attach surgical drapes or portions of drapes together. For example, U.S. Pat. No. 4,957,120 discloses a surgical drape including a pouch attached to the drape. The pouch may be attached by using releasable fastening systems such as those that include snap or VELCRO® fastener components. One part of the releasable fastening system is mounted on the drape and the complimentary part (of the releasable fastening system) is mounted on the pouch. Thus, because the drape material itself was not suitable for direct connection to a fastening component such as a VELCRO® hook fastener, complimentary elements must be attached to both joined portions. Similarly, U.S. Pat. Nos. 5,338,593, 5,010,899, and 5,345,946 disclose surgical drapes where one or both components of an attachment system, such as VELCRO® hook fasteners and a complimentary loop material that engages the hook fastener, may be attached to a drape for attaching the drape to another drape, the surgical table, etc. In many of these systems, adhesive or snaps are disclosed as alternatives to the VELCRO® hook fastener and the loop material.
In all the above patents, at least one component of the fastening system, be it a snap, VELCRO® hook fastener, etc., is attached to the drape or portion. Thus, this element must be added to the drape material during manufacture. The added element must be sized properly and must be placed properly in order to work in conjunction with the complimentary fastening element as desired. In situations where adhesive is used, it is typically attached to one drape of a pair to be attached. However, adhesive is not suitable for repeated positioning, and only the portion of the drape including the adhesive is fastenably positionable.
In situations where snap elements or VELCRO® hook fasteners and loop materials are used, each component of the fastening system must be respectively placed on the drapes (or portions) that are to be attached. Both corresponding components of the fastening system must be located properly on the drapes (or portions), and the fastening elements only connect the drapes or portions in one given orientation. Therefore, the attachment systems disclosed in the above patents work for their desired purposes of creating a connected drape system, but the systems are limited to only providing the connected drapes in one orientation and do not provide flexibility or adjustability.
U.S. Pat. No. 3,881,474 discloses a surgical drape that employs tabs that may be used to fasten surgical tools in place during a surgical procedure. The tabs are attached to the drape adjacent a reenforcement area around a fenestration opening on the drape. The tabs are attached at specific places between the reinforcement area and the drape and are not movable or adjustable. The tabs include holes through which surgical tools or a securing cord may be passed. Applicants understand that, in practice, medical personnel often simply use a clamp to secure a surgical tool to such a tab or to the drape itself, rather than expending the time and effort to loop the surgical tools through the holes or to tie them down using a securing cord. Furthermore, recent surgical advances have increased the number of surgical tools extending into a surgical site in many operations, thus compounding the complexity of the use of such a tab system.
U.S. Pat. No. 5,010,899 discloses a surgical drape including a plurality of binding strips of material attached to the upper surface of the drape for maintaining medical devices during a surgical procedure. The strips may include a fastening system that uses VELCRO® hook fasteners and an engageable loop material or an adhesive strip for sealing the strip over onto itself. The strips are limited to a single placement on the drape and thus do not provide flexibility or adjustability, especially in view of the demands of newer surgical procedures and tools.
Because the loops and tabs of the above patents are limited to a given set position on their respective drapes, different drapes must be designed for different surgical procedures on different parts of the body. Therefore, hospitals must stock numerous drape sets to cover different surgical possibilities. Similarly, because drape connection is limited by the position of the connectors, the hospitals must maintain a stock of various drape sets. The manufacture, purchase, and inventory of numerous drapes and drape sets by hospitals can be extremely expensive. Furthermore, as new surgical procedures are developed, new drape designs may be required. Since drape design typically follows the surgical advance, specifically-designed drapes may not be immediately available for new surgical procedures.
OBJECTS AND SUMMARY OF THE INVENTION
It is a principle object of the present invention to provide an improved surgical drape and surgical drape kit that can be readily adapted to various applications.
Another object of the present invention is to provide an improved surgical drape and surgical drape kit that are simple and inexpensive to manufacture, and that are reliable in use.
Still another object of the present invention is to provide a surgical drape and surgical drape kit that allow for reduction of hospital costs related to purchasing and inventorying various drape and drape kit designs.
Yet another object of the present invention is to provide a surgical drape and surgical drape kit that allow for infinite positioning and repositioning of surgical tools and drapes to provide flexibility to surgical personnel.
Another object of the present invention is to provide a surgical drape and surgical drape kit that can be used by medical personnel performing new procedures for which specific surgical drapes have not yet been designed, or that eliminates the need for the specific design entirely.
Still another object of the present invention is to provide a surgical drape and surgical drape kit providing reliable securing of surgical tools around a surgical site.
Yet another object of the present in
Dowdy Richard C.
Griesbach Henry L.
Hafer Gregory S.
Brown Michael A.
Dority & Manning P.A.
Kimberly--Clark Worldwide, Inc.
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