US3669106A

US3669106A - Surgical drape with adhesive attachment means

Info

Publication number: US3669106A
Application number: US58336A
Authority: US
Inventors: Mark S Schrading; Terry L Winters
Original assignee: Kimberly Clark Corp
Current assignee: Kimberly Clark Corp
Priority date: 1970-07-27
Filing date: 1970-07-27
Publication date: 1972-06-13
Anticipated expiration: 1989-06-13
Also published as: CA969439A

Abstract

A disposable surgical drape sheet, of the type having a nonwoven sheet for placing over a surgical patient and having a reinforced fenestration area with a fenestration to expose an operative area, is provided with a pair of elongated strips of normally tacky and pressure-sensitive adhesive along one pair of opposed edges of the fenestration. A pair of removable peel strips covering the adhesive strips are removed before using the sheet, thereby exposing the adhesive and permitting the sheet to be secured to the patient.

Description

United States Patent Schrading et a1.

[54] SURGICAL DRAPE WITH ADHESIVE ATTACHMENT MEANS [72] Inventors: Mark S. Schrading, Menosha; Terry L.

Winters, Neenah, both of Wis.

[73] Assignee: Kimberly-Clark Corporation, Neenah,

Wis.

[22] Filed: July27,l970

[21] App1.No.: 58,336

[52] U.S. Cl. ..128/132 D [51] Int. Cl. ..A6li 13/00 [58] Field oiSearch ..128/132 D, 155-157, 128/296 [56] References Cited UNITED STATES PATENTS 3,561,440 2/1971 Bayer ....l28/132 D 3,503,391 3/1970 Melges... ....l28/l32 D 3,561,439 2/1971 Bayer ..128/132 D [151 3,669,106 51 June 13, 1972 3,484,330 12/1969 Sokolowski et al. ..128/132 D 3,263,680 8/1966 Morgan ..128/132 D FOREIGN PATENTS 0R APPLICATIONS 668,402 8/1963 Canada 128/132 D 944,329 12/1963 Great Britain ..128/132 D Primary Examiner-Richard A. Gaudet Assistant Examiner-.I. B. Mitchell Anorney-Wolfe, Hubbard, Leydig, Voit & Osann. Ltd.

[57] ABSTRACT A disposable surgical drape sheet, of the type having a nonwoven sheet for placing over a surgical patient and having a reinforced fenestration area with a fenestration to expose an operative area, is provided with a pair of elongated strips of normally tacky and pressure-sensitive adhesive along one pair of opposed edges of the fenestration. A pair of removable peel strips covering the adhesive strips are removed before using the sheet, thereby exposing the adhesive and permitting the sheet to be secured to the patient.

6 Clains, 4 Drawing figures PATENTEDJum I972 3.669.106

WI) 4. IV/J ZZWJ SURGICAL DRAPE WITH ADHESIVE ATTACHMENT MEANS This invention relates generally to surgical drape sheets, and more particularly, to an improved disposable surgical drape having improved means for attaching the drape to a surgical patient.

Customarily, a patient who is to undergo surgery or the like is partly covered with a drape sheet having a generally central fenestration which exposes only the operative area. The previous use of cloth drapes for this purpose, with their attendant initial and laundry costs and their difficulty in sterilization, has now largely given way to the use of disposable drapes.

At present, disposable drapes are of two general types, namely those of a paper-like nonwoven fabric and those made of a plastic material. While both are used, they each have well recognized limitations. Nonwoven disposables, for example, tend to be somewhat more slippery than textile fabrics, and the use of skin clips or the like to secure the drape to the patient is inconvenient for the surgical team and perhaps painful for the patient. Plastic sheets generally tend to be even more slippery.

It has been proposed to overcome the disadvantages of disposable surgical drapes by utilizing adhesives to secure the drape in position. However, adhesive brushed or sprayed onto the patient is inconvenient at best, while adhesives applied to the drape have tended to hinder manipulation of the drape, particularly relocation of the drape after it is placed on the patient, which may be necessary if the drape is initially positioned incorrectly.

It is the primary object of the present invention to provide an improved disposable surgical drape that is securable to the patient without the need for skin clips or the like, yet can be readily relocated if necessary after the initial securement of the drape on the patient.

A more detailed object of the invention is to provide a disposable surgical drape having a reinforced fenestration area with a fenestration, which is adhesively secured to the patient both to prevent Slipping and to hold the drape flat to prevent instruments, fluids and the like from inadvertently getting under the drape through the fenestration.

Other and further aims, objects, and advantages of the invention will become apparent as the description proceeds, which description is in conjunction with the attached drawings wherein:

FIG. 1 is a top plan view of a laparotomy sheet embodying the invention;

FIG. 2 is an enlarged section taken along line 2-2 of FIG. 1 and in which the thickness of the several drape components is greatly exaggerated for reasons of clarity;

FIG. 3 is a bottom plan view of the laparotomy sheet of FIG. 1; and

FIG. 4 is a top plan view of a split sheet embodying the invention.

While the invention will be described in connection with certain preferred embodiments, it will be understood that it is not intended to limit the invention to these particular embodiments. On the contrary, it is intended to cover all alternatives, modifications, and equivalents as may be included within the spirit and scope of the invention.

Turning now to the drawings, the illustrative laparotomy sheet shown in FIG. 1 includes a base sheet comprising out layers of wadding and inner layers of highly drafted fibers disposed angularly to each other. A spaced-pattem of adhesive is disposed between each fiber layer and its adjacent wadding layer with the fibers in each fiber layer partially embedded in and held by the adhesive of its adjacent adhesive layer and partially embedded in and held by the adhesive in the other adhesive layer where it extends between the fibers of its adjacent fiber layer and with a portion of the adhesive in both adhesive layers joined where the adhesive patterns are superimposed. This material is described in more detail in copending Sokolowski et al. application Ser. No. 546,067 filed Apr. 28, 1966, now U.S. Pat. No. 3,484,330, and assigned to the assignee of the present invention.

In keeping with the present invention, a sheet of fluid impervious plastic film 11 is laminated to the top surface of the base sheet 10 over the primary operative area of the sheet, which in the exemplary embodiment is the fenestration area of the laparotomy sheet. A laparotomy sheet is an elongated, generally rectangular sheet used to cover all but the operative field of a patient during abdominal surgery, and is typically about 8 to 10 feet in length and about 5 to 8 feet in width. A fenestration or aperture 13 is located generally in the central region of the sheet, and is typically about 12 inches long by about 4 inches wide. The film 11 may be bonded to the fibrous base sheet 10 by any suitable means, such as by means of an adhesive or by extruding the film directly on the base sheet 10. The film 11 provides a fluid impervious barrier on the top surface of the operative area of the sheet 10, so'that any fluids which contact this area cannot strike through the sheet. It also prevents the transfer of bacteria through the sheet to insure sterile conditions in the operative area. The film must be capable of remaining stable under the conditions encountered in the particular treatment to which the laparotomy sheet is subjected to render it sterile, e.g., temperatures of about 270 F. for steam sterilization, or about 160 F. for sterilization by means of ethylene oxide or the like.

Examples of suitable films are polyethylene, e.g., 2-mil antistatic polyethylene film manufactured by Clopay Film Corp.; antistatic polypropylene, e.g., Extrel II available from Extrudo Film Corp.; polyethylene methylacrylate co-polymer film manufactured by Edison Plastics Company; and vinyl chloride films. The film should be substantially free of pinholes, and thus must generally be at least 1.5 mil thick, to provide the desired sterility barrier.

To provide a fluid absorbent outer surface on the drape, while at the same time providing a high frictional coefficient, a sheet of fluid absorbent flexible'plastic foam material 12 is laminated to the outer surface of the fluid impervious film 11. The foam material 12 may be bonded to the film 11 by any suitable means, such as by means of an adhesive, by fusing, or by extruding the film 11 directly on the foam material 12.

The absorbency of the absorbent open-cell foam l2 prevents excessive fluid runoff, and yet the absorbed fluids cannot strike through the drape because of the intermediate layer of fluid impervious film 11. The relatively high frictional coefficient of the foam material provides a substantially nonslip surface which prevents the accidental dislodgment of surgical instruments and the like. In addition, the foam 12 should havea low glare, which may be achieved by using a colored foam. Examples of suitable foams are 40 mil polyester polyurethane foam, available from Reeves Bros. or Tenneco Chemicals, Inc. having a density of 1.75 lbs./ft. and polyether polyurethane foams. The foam thickness should generally be in the range of from about 25 mils to about mils, and the absorbency of the foam sheet should be at least about percent and at least about 3 gm. per 4 X 4 inches sample, preferably at least 575 percent and at least 4.5 gm. per 4 X 4 inches sample. The foam sheet should also have a frictional coefficient of at least about 20.

In order to prevent sparking due to the buildup of static electrical charges on the drape, which can be hazardous with the potentially explosive gases that are often present in the operating room, the foam 12 should also be antistatic. It is not necessary for the intermediate film 11 to be antistatic unless the specific design of the drape is such that the film 11 is exposed in a certain area, e.g., around the operative opening in the fenestration area of a laparotomy sheet.

In accordance with the present invention, a pair of elongated strips of normally tacky and pressure-sensitive adhesive are bonded to the base sheet substantially coextensive with one pair of opposed edges of the fenestration, the elongated strips of adhesive being continuously spaced apart from each other by the fenestration, and the other pair of opposed edges of the fenestration being free of the adhesive to facilitate repositioning of the drape on the patient. The exposed adhesive is used to adhesively attach the drape to the patient both to prevent the drape from slipping on the patient and to hold the drape flat against the patient to prevent instruments, sponges, sutures and fluids from inadvertently getting under the drape. Thus, in the illustrative laparotomy sheet of FIGS. 1-3, a pair of

elongated strips

20 and 21 of normally tacky and pressuresensitive adhesive are bonded to the base sheet the full length of the longer or

longitudinal side edges

22 and 23, respectively, defining a major portion of the fenestration l3, and the width of the adhesive strips and 21 is such that they extend a substantial distance away from the

edges

22 and 23. The other pair of opposed edges of the fenestration 13, namely the end edges 24 and 25, are free of adhesive, so that the

elongated strips

20 and 21 are continuously spaced apart from each other by the fenestration 13. Consequently, the adhesive strips provided on the underside of the laparotomy sheet extend substantially in only one direction, thereby facilitating repositioning of the sheet after it has been placed on and secured to the patient. More specifically, if it is desired to reposition the laparotomy sheet after it has been initially placed on the patient, the sheet can be quickly removed from the patient by simply pulling it upwardly away from the patient in the longitudinal direction, i.e., there are no transverse adhesive attachments to impede the removal and re-positioning operations. After the sheet has been removed from the patient, it can be readily moved longitudinally in either direction to aline the fenestration 13 with the desired operative area on the patient.

Normally tacky and pressure-sensitive adhesives for use herewith may be any of the biologically acceptable pressuresensitive adhesives available. Adhesives of this class are generally composed of a film-forming elastomeric material, typically a natural or synthetic rubber, and some type of resin or other material to impart the desired degree of tack, wetting power, and specific adhesion. Typical resins include the rosin derivatives such as hydrogenated or dehydrogenated rosin or their esters. Various fillers, plasticizers, sterilizing agents, or other modifiers may also be used. For further descriptions of such adhesives, see Kirk-Othmer, Encyclopedia of Chemical Technology, Second Edition, Vol. 1, page 382 (Interscience I963).

To protect the adhesive-coated areas, peel strips 26 and 27 are employed to cover at least the

adhesive strips

20 and 21, respectively. The peel strips 26 and 27 are illustratively a plastic, heavy paper, or non-woven fabric having a release coating to which the

adhesive strips

20 and 21 can be secured only lightly. Coatings suitable for this purpose include natural or synthetic waxes, metal salts of fatty acids, polymeric materials such as polyethylene or silicone polymers, etc. Release coatings are discussed in Kirk-Othmers Encyclopedia", Second Edition, Vol. 1, page 1 et seq.

As shown most clearly in FIGS. 2-4, the peel strips 26 and 27 preferably extend slightly beyond the outboard longitudinal edges of the respective adhesive strips to facilitate removal of the peel strips when it is desired to place the drape on the patient. Other types of peel strips, such as slit strips, may also be used to facilitate removal, but is has been found that the extended liner shown in FIGS. 2-4 provides significant advantages in facilitating removal, minimizing removal time and preserving aseptic conditions.

One particularly preferred technique for applying the

adhesive strips

20 and 21 and the corresponding peel strips 26 and 27 to the laparotomy sheet is to apply the adhesive and peel strip simultaneously in pre-laminated form. One especially suitable starting material for this technique is Minnesota Mining and Manufacturing Product No. 1522, which comprises a continuous strip of double-coated adhesive transfer tape consisting of polyethylene film coated on both sides with an acrylic copolymer adhesive. The tape is laminated to a continuous release strip or liner supplied in continuous release roll form. The tape thickness is 6 mils, the liner thickness is 5 mils, and the tape demonstrates 30 oz./in. adhesion to steel and has a moisture vapor transport rate of 0.85 gm./l00 in./24 hours. A suitable tape width for laparotomy drapes is 2 inches, although the invention is not limited to this particular width.

When the transfer tape is cut in to appropriate lengths and applied to a laparotomy sheet, for example, the adhesive on one side of the polyethylene film strip bonds the strip to the base sheet 11, while the adhesive on the other side is protected by the release strip until removal of the release strip at the time of application of the drape to the patient. The use of this material provides an extremely efficient manufacturing technique, and one which can be carried out at high production rates. Moreover, it has been found that surgical drapes having the aforementioned film-adhesive starting material applied thereto can be subjected to conventional ethylene oxide sterilization techniques (the polyethylene film cannot be sterilized by autoclaving) without suffering degradation of the adhesive. Sterility tests conducted with bacillus subtilis spore strips, laminated between the tape and the nonwoven fabric, or between the tape and its release strip, showed that no growth occurred (incubation at 37 C. for 7 days) after the laminates were subjected to a conventional ethylene oxide sterilization treatment. Furthermore, it has been found that the aforementioned transfer tape provides a stronger bond between the tape and the base sheet 11 than the bond between the tape and the patients skin, thereby further facilitating repositioning of the drapes during a surgical operation. This tape also has good aging characteristics and is safe for contact with human skin.

In an alternative embodiment of the invention illustrated in FIG. 4, the two adhesive strips 30 and 31 of normally tacky and pressure-sensitive adhesive are bonded to opposite side edges of the elongated opening in a conventional split sheet 32. When the peel strips 33 and 34, respectively, are peeled off the adhesive strips 30 and 31, the exposed adhesive is used to adhesively attach the split sheet 32 to the patient both to prevent the sheet from slipping on the patient and to hold the sheet flat against the patient to prevent instruments, sponges, sutures and the like resting on the foam top surface of the fenestration area of the sheet from inadvertently getting under the sheet. The adhesive attachment of the sheet also prevents the sheet from hindering the surgeon in the operative field. Since the adhesive strips 30 and 31 are disposed on only one pair of opposed side edges of the opening, the split sheet 32 can be readily repositioned in the same manner described above for the laparotomy sheet, i.e., it can be detached from the patient by pulling it upwardly away from the patient in a longitudinal direction, and then moved to the desired position before being reattached to the patient.

We claim as our invention:

1. An improved disposable surgical drape comprising the combination of a fibrous base sheet having an opening, a fluid impervious plastic film secured to said base sheet over the primary operative area of said sheet and forming a fenestration area with an opening smaller than and within said fenestration area, a sheet of fluid absorbent flexible open cell plastic foam material laminated to the top surface of said film in said fenestration area and forming an opening said openings in said base sheet, plastic film and foam material being substantially coextensive and forming a fenestration in said fenestration area, a coating of normally tacky and pressure sensitive adhesive applied to the under surface of said base sheet substantially coextensive with opposite edges of a major portion of said fenestration, and removable peel strips covering said adhesive coating; said film, said foam, and said adhesive all being stable at sterilizing temperatures to permit sterilization of the surgical drape, the combination of l) the fluid impervious plastic film and fluid absorbent foam on the drape top surface, and (2) the adhesive on the drape under surface, providing an absorbent reinforced area with a frictional top surface adjacent the fenestration for absorbing fluid such as body fluid while preventing strike-through of such fluid, for holding items such as instruments, sponges and sutures supported thereon from accidental dislodgement, and enabling the drape to be attached to a patient both to prevent the drape from slipping on the patient and to hold the drape flat against the patient adjacent the fenestration to prevent such items and fluids from inadvertently getting under the drape through the fenestration.

2. A drape according to claim 1 wherein said fenestration has straight opposite edges, and said coating of adhesive is applied to the drape under surface in the form of straight strips immediately adjacent said straight opposite edges of said fenestration.

3. A drape according to claim 2 wherein said straight adhesive strips lie parallel to and immediately adjacent said straight opposite edges of the fenestration, and the other edges of said fenestration are free of adhesive.

4. A drape according to claim 1 wherein said foam is a colored foam to reduce glare.

5. An improved disposable surgical drape comprising the combination of a fibrous base sheet having an opening, a fluid impervious plastic film secured to said base sheet, extending over the primary operative area of said sheet and forming a fenestration area with a fenestration smaller than and within said fenestration area, a sheet of fluid absorbent flexible open cell plastic foam material substantially coextensive with and laminated to the top surface of said film throughout said fenestration area and forming an opening said foam having a frictional coefficient of at least about said openings in said base sheet, plastic film and foam material being substantially coextensive and forming a fenestration in said fenestration area, a coating of normally tacky and pressure sensitive adhesive applied to the under surface of said base sheet substantially coextensive with opposite edges of said fenestration, and removable peel strips covering said adhesive coating; said film, said foam, and said adhesive all being stable at temperatures up to at least about 160 F to permit sterilization of the surgical drape, the combination of l) the fluid impervious plastic film and coextensive fluid absorbent foam on the drape top surface and (2) the adhesive on the drape under surface, providing a top surface entirely around the fenestration for absorbing fluid such as body fluid, while preventing strikethrough of such fluid, providing a reinforced frictional top surface entirely around the fenestration where the drape is subject to extreme stress to hold items such as instruments,

sponges and sutures supported thereon from accidental dislodgement, and enabling the drape to be attached to a patient both to prevent the drape from slipping on the patient and to hold the drape flat against the patient adjacent the fenestration to prevent such items and fluids from inadvertently getting under the drape through the fenestration openmg.

6. An improved disposable surgical drape comprising the combination of a reinforced porous fibrous base sheet forming a fenestration opening, a fluid impervious plastic film secured to said base sheet over the primary operative area of said sheet and forming a fenestration area with a fenestration opening smaller than and within said fenestration area, a sheet of fluid absorbent flexible open cell plastic foam material laminated to the top surface of said film in said fenestration area and forming an opening, said openings in said base sheet, plastic film and foam material being substantially coextensive and forming a fenestration in said fenestration area, a coating of normally tacky and pressure sensitive adhesive applied to the under surface of said base sheet substantially coextensive with opposite 1 edges of said fenestration, and removable peel strips covering said adhesive coating; said film, said foam, and said adhesive all being stable at sterilizing temperatures to permit sterilization of the surgical drape, the combination of l) the fluid impervious plastic film and fluid absorbent foam on the drape top surface and (2) the adhesive on the drape under surface, providing a top surface adjacent the fenestration for absorbing fluid such as body fluid while preventing a strike-through of such fluid, providing a further reinforcement and a frictional top surface adjacent the fenestration to hold items such as instruments, sponges and sutures supported thereon from accidental dislodgement, and enabling the drape to be attached to a patient both to prevent the drape from slipping on the patient and to hold the drape flat against the patient adjacent the fenestration to prevent such items and fluids from inadvertently getting under the drape through the fenestration.

Claims

1. An improved disposable surgical drape comprising the combination of a fibrous base sheet having an opening, a fluid impervious plastic film secured to said base sheet over the primary operative area of said sheet and forming a fenestration area with an opening smaller than and within said fenestration area, a sheet of fluid absorbent flexible open cell plastic foam material laminated to the top surface of said film in said fenestration area and forming an opening said openings in said base sheet, plastic film and foam material being substantially coextensive and forming a fenestration in said fenestration area, a coating of normally tacky and pressure sensitive adhesive applied to the under surface of said base sheet substantially coextensive with opposite edges of a major portion of said fenestration, and removable peel strips covering said adhesive coating; said film, said foam, and said adhesive all being stable at sterilizing temperatures to permit sterilization of the surgical drape, the combination of (1) the fluid impervious plastic film and fluid absorbent foam on the drape top surface, and (2) the adhesive on the drape under surface, providing an absorbent reinforced area with a frictional top surface adjacent the fenestration for absorbing fluid such as body fluid while preventing strike-through of such fluid, for holding items such as instruments, sponges and sutures supported thereon from accidental dislodgement, and enabling the drape to be attached to a patient both to prevent the drape from slipping on the patient and to hold the drape flat against the patient adjacent the fenestration to prevent such items and fluids from inadvertently getting under the drape through the fenestration.

5. An improved disposable surgical drape comprising the combination of a fibrous base sheet having an opening, a fluid impervious plastic film secured to said base sheet, extending over the primary operative area of said sheet and forming a fenestration area with a fenestration smaller than and within said fenestration area, a sheet of fluid absorbent flexible open cell plastic foam material substantially coextensive with and laminated to the top surface of said film throughout said fenestration area and forming an opening said foam having a frictional coefficient of at least about 20*, said openings in said base sheet, plastic film and foam material being substantially coextensive and forming a fenestration in said fenestration area, a coating of normally tacky and pressure sensitive adhesive applied to the under surface of said base sheet substantially coextensive with opposite edges of said fenestration, and removable peel strips covering said adhesive coating; said film, said foam, and said adhesive all being stable at temperatures up to at least about 160* F., to permit sterilization of the surgical drape, the combination of (1) the fluid impervious plastic film and coextensive fluid absorbent foam on the drape top surface and (2) the adhesive on the drape under surface, providing a top surface entirely around the fenestration for absorbing fluid such as body fluid, while preventing strike-through of such fluid, providing a reinforced frictional top surface entirely around the fenestration where the drape is subject to extreme stress to hold items such as instruments, sponges and sutures supported thereon from accidental dislodgement, and enabling the drape to be attached to a patient both to prevent the drape from slipping on the patient and to hold the drape flat against the patient adjacent the fenestration to prevent such items and fluids from inadvertently getting under the drape through the fenestration opening.

6. An improved disposable surgical drape comprising the combination of a reinforced porous fibrous base sheet forming a fenestration opening, a fluid impervious plastic film secured to said base sheet over the primary operative area of said sheet and forming a fenestration area with a fenestration opening smaller than and within said fenestration area, a sheet of fluid absorbent flexible open cell plastic foam material laminated to the top surface of said film in said fenestration area and forming an opening, said openings in said base sheet, plastic film and foam material being substantially coextensive and forming a fenestration in said fenestration area, a coating of normally tacky and pressure sensitive adhesive applied to the under surface of said base sheet substantially coextensive with opposite edges of said fenestration, and removable peel strips covering said adhesive coating; said film, said foam, and said adhesive all being stable at sterilizing temperatures to permit sterilization of the surgical drape, the combination of (1) the fluid impervious plastic film and fluid absorbent foam on the drape top surface and (2) the adhesive on the drape under surface, providing a top surface adjacent the fenestration for absorbing fluid such as body fluid while preventing a strike-through of such fluid, providing a further reinforcement and a frictional top surface adjacent the fenestration to hold items such as instruments, sponges and sutures supported thereon from accidental dislodgement, and enabling the drape to be attached to a patient both to prevent the drape from slipping on the patient and to hold the drape flat against the patient adjacent the fenestration to prevent such items and fluids from inadvertently getting under the drape through the fenestration.