CA2062227A1 - Surgical drape - Google Patents

Abstract

ABSTRACT

A pelviscopy drape and a laparoscopic cholecystectomy drape define openings through which access can be had to a surgical site during the performance of laparoscopic gynecological and laparoscopic cholecystectomy procedures. The openings are sized, shaped, and positioned to permit use of the drape with patients of virtually any size.

Description

~2~27 BACKGROUND OF THE INVENTION

The present invention relates to surgical drapes and, more particularly, to surgical drapes that are useful during the performance of laparoscopic surgical procedures.

Surgical drapes are used during the performance of all types of surgical procedures. A surgical drape is constructed of either a disposable or nondisposable material. If it is constructed of a nondisposable material, it can be used for a number of surgical procedures if it is rewashed, packaged and sterilized before each procedure.

A surgical drape is used to define the boundaries of a sterile field. A sterile field creates an imaginary barrier or plane between the sterile and unsterile members of the operative team and between the sterile members of the operative team and the surgi~al area. Unsterile personnel or objects are not permitted to cross the barrier to permit making the assumption that the surgical or incisional site is aseptically clean. The sterile members of the sterile surgical team, thus, can come into contact with the patient without being contaminated or contaminating the "prepped" surgical site. Contamination of the surgical field or surgical team members implies the introduction of bacteria or foreign material into the incisional area.

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Creation of the sterile field begins after the patient has been "prepped," or prepared with some type of antiseptic solution. Paper towels or cloth towels are used to define the boundaries of the sterile operative field. The surgical site is incorporated by the towels and a surgical drape, which together create the boundaries for the sterile field. The drapes used during specialized suryical procedures define an opening, aperture, or "fenestration" that defines the boundaries of the surgical site peculiar to the procedure. The size and shape of the drape depend on the type of procedure that will be performed. The size, shape, and placement of the fenestrations or apertures of the drape also reflect the planned procedure.
After the towels are placed, either a nondisposable or disposable one-piece surgical drape with an aperture that defines the proposed incisional area or surgical site is placed on the patient.

Laparoscopic surgical procedures are being performed with increasing frequency. They have been proven to be safe, efficient, cost effective, and less invasive. In particular, abdominal laparoscopic surgery is increasingly replacing conventional abdominal procedures. Laparoscopy, a form of endoscopic surgery, is, by simple definition, the act of looking into the abdomen by means of a telescope. The telescopes are miniaturized and, in many cases, are as small as 5 mm. in diameter. They range in overall length from 33 cm. to 45 cm.
Usually a 10 mm. diameter telescope is inserted through a small 2 ~ 7 incision made in the belly button, or umbilical area or region, for diagnostic purposes. The procedure, thus, is designated a ndiagnostic" laparoscopic procedure.

Additional puncture wounds or incisions, usually made in the area above the pubic bone, commonly referred to as the suprapubic area, are utilized to introduce ancillary instrumentation. Hollow trochar sleeves are placed through these additional incisions. The sleeves are usually 5 mm. in diameter. Instruments are inserted through the trochar sleeves that enable the performance of true operative procedures. The procedure, thus, is called an "operative" laparoscopy. Usually only two or three suprapubic incisions, or puncture wounds, are required. Thus, commonly, one incision is made in the umbilical area and two are made in the suprapubic region, collectively defining a multiple puncture "operative" laparoscopic procedure.

Operative laparoscopy is intended to be a replacement for conventional surgical intervention with a conservative, minimally invasive procedure most often performed in an out-patient setting. Standard surgical procedures necessitate a three- to five-day stay in the hospital with three- to four-week recovery time at home. Operative pelviscopy (a laparoscopic gynecologic procedure) or laparoscopy requires very small incisions. Outpatient surgery enables the patient to return home the same day, recovery time being reduced to three days at home ~ ` ~ 2 ~

with return to work on post-operative day four or five.
Operative laparoscopy can replace traditional invasive surgery for the diagnosis and treatment of benign gynecologic disease.
The scope of these procedures at this time is limited only by available technology and the surgeon's imagination.

Cholecystectomy, by definition, is the surgical excision of the gallbladder. General surgeons have recently become interested in the use of operative laparoscopy as a substitute for conventional cholecystectomies. Laparoscopic cholecystectomies, which have been performed successfully for approximately two years, require a four puncture technique. One 10 mm. incision is made in the umbilical area for the telescope. Another 10 mm. incision is made in an area approximately one half the distance between the end of the breast bone, commonly referred to as the xiphoid cartilage, and the umbilicus. Two 5 mm. punctures are made below the rib case, commonly referred to as the subcostal region, on the patient's right side. The second 10 mm. and the two 5 mm. incisions are used for the introduction of ancillary instrumentation. The S
mm. instruments are used for manipulation and retraction of the gallbladder. The second 10 mm. port permits the introduction of dissectors, clip applying devices, scissors, and the laser or electrocautery device for removal of the gallbladder from the liver bed. A cholangiogram, which requires the introduction of a catheter into the common bile duct and injection of x-ray dye, can be performed through this opening. The cholangiogram helps to identify the presence of gallstones in the common bile duct.

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Additional procedures that are being developed in general surgery include repair of inguinal hernias with Marlex mesh. Appendectomy procedures can be completed laparoscopically with the introduction of conventional pelviscopic e~uipment and the addition of a 10 mm. puncture to the right of the patient's umbilicus. This allows introduction of the clip applier for ligation of the blood supply to the appendix. Operative endoscopy for general surgery is still in its infancy.

Conventional abdomino-pelvic surgery requires a large incision through which access to the entire abdominal cavity is gained. Accordingly, drapes used with conventional procedures define a large rectangular opening that encompasses the entire sterile surgical site. The rectangular opening would be positioned over either the pelvic or abdominal area.
Laparoscopic or endoscopic surgical procedures were initially performed in the pe]vic area and required a smaller surgical site. Accordingly, drapes were developed that defined a smaller rectangular opening than those provided with the drapes that were used for conventional laparotomy procedures.

Additionally, performance of laparoscopic gynecologic procedures often requires manipulation of the uterus.
Manipulation of the uterus is accomplished through the vagina.
Also, a foley or indwelling catheter usually is inserted into the bladder through the urethra to empty the bladder and keep it 2 ~

empty during performance of the surgical procedure. Thus, conventional drapes were modified to provide a square or rectangular perineal opening. The perineal opening was located over the vaginal area when the upper opening was properly positioned on the abdomen.

However, the abdomino-pelvic opening of the laparoscopic drapes has proved to be unsatisfactory for advanced, or "operativen pelvic endoscopic ("pelviscopic") surgical procedures. The opening proved to be too narrow to allow access to the site of the ancillary, suprapubic punctures. Therefore, gynecologic surgeons commonly widened the opening at the top and bottom of the rectangle by cutting the drapes and folding back the edges of the newly created opening. Sometimes the surgeon would widen only the bottom of the rectangle by making a cut on either side of the base of the rectangle and folding back the cut material to form a "triangular" opening having a flat top that corresponded to the original top of the rectangle.

However, cutting a drape to provide a proper opening is not a satisfactory solution for several reasons. Cutting a disposable drape risks contamination of the incision from fibers produced at the cut. These fibers can be carried into the incision, thus creating the potential for a foreign body reaction in the patient's abdomen or pelvic cavity as well as creating the potential for infection, abscess, or scar formation. Altering either a disposable or nondisposable drape also increases the 2 0 ~
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surgical time, and proves cumbersome and distractiny to the surgeon. As the surgical procedure progresses, it is also possible that, because the integrity of the aperture has been compromised, the openings may become enlarged, thus creating a contaminated surgical field. Non-disposable, or reusable, drapes cannot be cut without rendering them unusable for subsequent procedures.

Also, an enlarged opening cut beyond the waterproof or water resistant area of the drape, which usually surrounds the original aperture, presents a nonwaterproof or non-water resistant area that is in direct contact with the incision. A
nonwaterproof or non-water resistant area adjacent the surgical site creates the potential for "strike through," or absorption of liquid material through the drape into the unsterile area.
Bacteria can migrate back up through that same area, causing contamination of the sterile surgical field.

It is, thus, imperative for the drape aperture or fenestration to be of the proper size, configuration, and location for the laparoscopic procedure~ Appropriate aperture size, shape and position eliminates the need to cut or tear the drape prior to conducting the surgical procedure. The width of the opening is critical, as it determines the width of the site available for the suprapubic punctures required by the surgical procedure. The larger the body mass of the patient, the greater the distance required between the two (or more) puncture sites in 2 ~ f~ ~

the suprapubic region. Therefore, the height and weight of the patient determines the required size of the surgical site, the required size increasing with the height and weight of the patient.

The drape opening must ~e large enough to permit proper placement of the suprapubic punctures, yet not so large that too much of the patient's abdomen is exposed. Accordingly, thexe exists a need for surgical drapes that are particularly useful for such laparoscopic surgical procedures as pelviscopies and cholecystectomies. There also exists a need for surgical drapes that can be used with patients of all heights and shapes without cutting the drape opening or otherwise altering the opening size, location or shape.

SUMMARY OF THE INVENTION
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The surgical drapes provided by the present invention are particularly useful for one or more types of laparoscopic surgical procedures, for example, pelviscopies and laparoscopic cholecystectomies. Each drape can be used for patients of all sizes and weights without altering the size, shape or placement of the opening. Thus, there is no need to produce a series of drapes having various opening sizes and locations to accommodate different patients.

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2 ~ 2 ~ fi The present invention provides a surgical drape for covering a patient during surgery to define a sterile field. The drape includes a sheet of flexible material defining an opening providing access to a surgical site during the performance of surgery on the patient. The opening defines a registration area that can be positioned at the site of the suprapubic incisions to position the opening properly on the patient's abdomen. The width of the opening decreases with distance from the registration area. The sheet includes a water resistant or waterproof zone surrounding the opening. Accordingly, the opening provides a wider effective surgical site for larger patients while maintaining an effective sterile field for smaller patients.

The present invention also provides a surgical drape for covering a patient during surgery to define a sterile field. The drape includes a sheet of flexible material defining an access area that can be positioned at a patient's suprapubic area and through which incisions can be made in the suprapubic area of the patient. An umbilical access area provides access to the umbilical area of the patient when the suprapubic access area is positioned to permit access to the suprapubic area of the patient. The suprapubic access area permits the formation of at least two suprapubic access incisions.

The present invention also provides a surgical drape for covering a patient during the performance of a laparoscopic cholecystectomy to define a sterile field. The drape includes a sheet of flexible material ~efining an umbilical access area through which an incision can be made near the umbilicus of a patient and at least two additional incisions can be made lateral to the umbilical incision in the subcostal area. The sheet also defines a lateral quadrant access area through which an incision can be made in the right lateral quadrant of the patient.

The present invention also provides a surgical drape for covering a patient during the performance of a laparoscopic cholecystectomy to define a sterile field. The drape includes a sheet of flexible material defining an opening providing access to a surgical site during the performance of the cholecystectomy. The opening defines a registration point that can be positioned at the umbilicus of the patient to position the opening properly on the patient's abdomen. The opening defines an area above the registration point that permits access to the right lateral quadrant of the patient, and a subcostal area that provides access to the subcostal area of the patient.

BRIEF DESCRIPTION OF THE DRAWINGS

The following detailed description of the preferred embodiments can be understood better if reference is made to the drawing, in which:

Fig. 1 shows a surgical drape provided by the present invention that is particularly useful for laparoscopic gynecologic, or pelviscopic, surgery;

Fig. 2 shows a surgical drape provided by the present invention that is particularly useful for laparoscopic cholecystectomies;

Fig. 3 shows a patient in the lithotomy position;

Fig. 4 shows the pelviscopy drape shown in Fig. 1 in place on a patient in the lithotomy position;

Fig. 5 shows the cholecystectomy drape shown in Fig. 2 in place on a patient;
, Fig. 6 shows a sectional view of the hem formed on the abdominal opening of the drape shown in Fig. l; and Fig. 7 shows a portion of the hem on the abdominal opening of the drape shown in Fig. 1.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

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Figure 1 shows a pelviscopy drape and Figure 2 shows a cholecystectomy drape. The pelviscopy drape is particularly useful during the performance of laparoscopic gynecologic (or "pelviscopic") procedures. The cholecystectomy drape is particularly useful during the performance of laparoscopic cholecystectomies. Both drapes generally define a wider upper section and a narrower lower section which together form, broadly, a "T." The pelviscopy drape defines two fenestrations, or openings. One of the openings, the abdominal opening, is generally triangular in shape and provides access to the incisional or surgical site. The second, perineal, opening is rectangular and provides access to the perineal area. The cholecystectomy drape defines a single abdominal opening that provides access to the surgical site. All openings are bounded by a hem, and the abdominal openings are surrounded by a waterproof or water resistant zone.

Figure 1 shows pelviscopy drape 10, which can be reusable or disposable. Drape 10 is formed from sheet 12. If drape 10 is reusable, sheet 12 is fabricated from a cloth material, preferably a cotton blend of the type commonly used to fabricate conventional surgical drapes. If drape 10 is disposable, sheet 12 is formed from a paper material, preferably of the type marketed by Kimberly Clark/Baxter Healthcare Corporation under the trademark "KIMGUARD." A suitable hem 14 is formed around the edge of sheet 12.

Sheet 12 forms two sections 16 and 18. Upper section 16 includes a waterproof or water resistant zone 20. Zone 20 prevents water from soaking through drape 10 to nonsterile areas 2~2~

of the patient and carrying bacteria or other foreign material through drape 10 to the sterile field. Zone 20 of a reusable drape is water resistant, and is formed by sewing onto section 16 hemmed material having a tighter weave than the material forming section 16. Zone 20 of a disposable drape is formed by bonding a tight weave paper material to the underside of section 16. A
flexible plastic sheet (not shown~ is sandwiched between section 16 and the tight weave material. The plastic sheet is of any type known to drape manufacturers and used to form waterproof zones in conventional disposable drapes. The plastic sheet renders zone 20 waterproof rather than merely water resistant.
Suitable water resistant and waterproof materials and the methods of forming zones 20 and securing them to drapes 10 are well known to those in the drape art.

A generally triangular opening 22 is formed in section 16 and zone 20 near the union of sections 16 and 18. Triangular opening 22 provides the surgeon with access to the incisional or surgical site. Opening 22 defines an apex 34, bottom corners 38 and 40, and bottom edge 36. Suitable material is used to form a hem 24 around the edge of opening 22, as is explained in more detail below. Similarly, suitable material is used to form a hem 28 on the edge of zone 20. A rectangular opening 30 is formed in section 18 near the union of sections 16 and 18. Suitable material is sewn onto the edge of opening 30 to provide a hem 32. Opening 30 provides access to the perineal area of the patient.

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Figures 6 and 7 show the details of hem 24 formed on the perimeter of opening 22 of drape 10. Hem 24 prevents fibers from the end of sheet 12 and zone 20 from becoming dislodged and contaminating the surgical site. Any suitable hem 24 can be formed around opening 22, but the arrangement shown in Figs. 6 and 7 is particularly effective. Hem 24 shown in Figs. 6 and 7 is formed from a narrow strip of material that is sewn around the edges of opening 22. One side 23 overlaps part of zone 20 and the remaining side 25 overlaps material 12. The material is secured to the ends ~f sheet 12 and zone 20 with ordinary stitching 21. The edges of opening 22 of a disposable drape 10 can be sealed in any manner presently known to the drape industry.

Loops 26 of drape 10 are used for maintaining tubing and connecting cords in place on the sterile area. Loops 26 are strategically placed as shown in the drawing to allow the cords to be maintained on the patient's body without hanging below the boundary of the sterile field. Loops 26 obviate the need to apply clamps to maintain the position of the cords and insufflation tubings, which clamps otherwise would increase the risk of penetration of the instrumentation through the drape and contamination of the sterile area. Loops 26 of a disposable drape 10 would be made from paper material, usually a tough material that would withstand the tugging of the tubing. Loops 26 of a disposable drape 10 could be fabricated from twill tape, 2 2 '~

which is a cotton material. Loops 26 must be large enough to receive multiple cords without placing undue stress on the connection of loops 26 to sheet 12. The connection of loops 26 to drape 10 is completed by sewing loops 26 to the edge of the reinforced water resistant zone 20 in a reusable drape 10, and at the seam of the waterproof zone 20 of a disposable drape 10 Loops 26 are located to permit access to loops 26 by the surgical team without allowing the cords to fall below the level of the waist of the surgical team.

The dimensions, in inches, indicated by letters A
through M in Figure 1 are as follows:

~- 31 There are a number of laparoscopic gynecological procedures for which pelviscopy drape 10 is particularly useful. One procedure, called a "diagnostic" laparoscopy, requires the insertion of a 10 mm. trochar through a vertical or horizontal incision made in the umbilicus. The sleeve of the trochar is maintained in place, and telescopes are introduced through the sleeve into the abdomen. If an "operative"
laparoscopy is to be performed after exploration of the abdomen, at least one, and usually two, additional 5 mm. punctures are introduced suprapubicly in a position medial to the iliac crests~ Transillumination (the illumination of the abdominal wall from within the abdomen) is performed first to reveal and avoid the puncture of major vasculature, which many times determines the site of the punctures. Once the sleeves are in place, instrumentation can be introduced into the pelvis through the sleeves to manipulate; cut, and remove specimens. At times, a 5 mm. scope is introduced through one of the 5 mm. ports to allow removal of specimens through the 10 mm. port. Procedures that are carried cut in this fashion are lysis of adhesions, either in a simplistic or more advanced state in which there is involvement with bowel and other organs. Types of procedures that can be performed by pelviscopy are lysis of adhesions (the removal or separation of scar tissues), myomectomy ~the removal of benign tumors), oophorectomy (the removal of the ovaries), salphingectomy (the removal of tubes) and hysterectomy (the removal of the uterus). Removal of the specimen from the abdomen, in most cases, can be achieved through the 10 mm. port 2'~

orS if the specimen is too large, through a colpotomy incision in the vaginal vault.

To perform an advanced operative laparoscopy (the terms "laparoscopyn and "advanced operative laparoscopy" both referring to all laparoscopic procedures involving multiple punctures), the patient is positioned flat on the back with the legs straight, and the arms are placed on arm boards. Thus, the patient is lying in a "T-type" position. Then the patient is anesthetized. Allen stirrups are utilized for positioning the legs in a lithotomy position, or a position in which the legs are spread apart, allowing access to the perineal area. The thighs are maintained in a position horizontal to the body. The knees are flexed or bent, and the lower portion of the leg is positioned at a 45 to 90 angle to the body. The patient appears to be in a standing position with knees bent, although she is lying on her back. Either the patient's arms are tucked at the side of the patient or one arm is tucked and the other arm is positioned on an arm board. After prepping with an antiseptic solution, the patient must be draped with cloth towels to isolate or define the intended surgical area. The patient's legs are then enveloped with covers that look like large pillow cases.
Each leg cover is sealed at the sides and at the bottom to incorporate and encapsulate the leg to prevent contamination of the scrub nurse, who is usually positioned between the patient's legs during the performance of the surgical procedure.

Figure 4 shows drape 10 in position on a patient in the lithotomy position with the arms positioned on arm boards. Drape 10 is then so positioned that the portion of the opening 22 just above base 36, referred to herein as the nrPgistration area" or the suprapubic access area of opening 22, is positioned over the suprapubic area of the patient, which ensures proper positioning of opening 22 over the pelvic area. Drape 10 then is opened, and upper section 16 is positioned over the upper part of the patient's body, including over the patients arms. Section 16 thus covers either the arm board on which the patient's arm is extended and the patient's remaining tucked arm, or the tucked arms if both arms are tucked at the patient's sides. Lower section 18 of drape 10 then is pulled down to cover the perineal area between the patient's legs. Perineal opening 30 provides access to the perineal area. Leg covers, not shown, encapsulate the patient's legs. The patient, thus, is positioned entirely beneath the surgical barrier, creating a sterile field above drape 10 which enables the sterile members of the surgical team to be in contact with the patient without contaminating either the sterile team or the surgical site. With drape 10 so positioned, the 10 mm. puncture 102 can be placed beneath the umbilicus and the two additional punctures 104 and 106 can be placed approximately 8 cm. from the midline area 42 suprapubicly.

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The shape and size of opening 22 and the location of opening 22 on sheet 12 permit use of drape 10 with patients falling within a wide range of sizes and weights. The size and weight of a patient determines, in large part, the spacing required among the umbilical incision 102 and suprapubic incisions 104 and 106. Generally, the larger the patient, the farther apart incisions 102, 104 and 106 must be. The triangular shape of opening 22 permits accommodation of a variety of spacings without providing an opening that is too large for smaller patients. For larger patients, umbilical incision 102 will be located near apex 34, while suprapubic incisions 104 and 106 would be located closer to bottom edge 36 and corners 38 and 40. Suprapubic incisions 104 and 106 for smaller patients would be located at the same distance from base 36, but umbilical incision 102 would be located farther from apex 34.

Figure 2 shows cholecystectomy drape 70. Drape 70 is identical to drape 10 with the exception of the width of lower section 72, the shape and placement of abdominal opening 74 and the absence of a perineal opening 30. Opening 74 is sized, shaped and positioned to facilitate performance of laparoscopic cholecystectomies. Opening 74 is defined by a pair of parallel side edges 76 and 78, a bottom edge 80 that is generally perpendicular to each of edges 76 and 78, and a top edge 82 that meets edges 76 and 78 at oblique angles. As with drape 10, a rectangular or square water resistant or waterproof zone 84 is provided. With the exception of the opening formed in zone 84, 2 2 ~
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zone 84 is formed in the same manner as zone 20 is formed.
Suitable material is also formed around the edges of opening 74 to form a hem 88 in the same manner as hem 24 is formed around opening 22 of drape 10. Loops 92 can be identical in construction and function to loops 26 and are placed at the same locations at the edge of zone 84 of drape 70.

The dimensions, indicated by the reference characters A
through K shown on Figure 2, are, in inches:
A- 99 1/4, B- 9 1/4, C- 11, D- 5, F- 19, G- 19, H- 53, I- 61 1/4, ; ~ J~ 57 1/4, K- 39 1/2.

Cholecystectomy drape 70 is useful for maintaining a sterile field during the performance of laparoscopic cholecystectomies, in which access to the gallbladder is provided through a laparoscope. A 10 mm. incision 120 is made beneath the umbilicus and a trochar sleeve is introduced into the abdomen through the incision. A telescope is inserted throu~h the 2 2 ~

trochar and into the abdomen, and the liver and gallbladder area, which is in the right upper quadrant, is examined. First and second 5 mm. punctures or incisions 122 and 124 are made lateral to the umbilicus in the subcostal area. A second 10 mm. incision 126 is made in the left lateral quadrant, or slightly to the right of midline of the abdomen, depending on the anatomy of the patient, and a 10 mm. trochar is inserted through that incision. The 5 mm. ports are used for instruments that grasp and manipulate the gallbladder. The second 10 mm. puncture 126 is used for introduction of the clip applier, the laser, scissors, and dissecting instrumentation. If a cholangiogram is performed, a third 5 mm. incision would be made in the gallbladder region, which would be near the first two 5 mm.
sleeves, for the cholangiocath and introduction of radiopaque dye for illumination of the common duct.

Figure 5 shows drape /0 in place on a patient, alternately in the lithotomy position (position L) and the dorsal recumbent position (position D). To use drape 70 during a laparoscopic cholecystectomy, the patient is positioned flat on their back, with legs straight. The arms are extended on arm boards, to place the patient in a "T," or dorsal recumbent, position D. A rolled towel is placed under the patient's right shoulder blade to cause the patient to roll toward the left.
Either both arms would be tucked at the sides, or the right arm would be tucked and the left arm extended on an arm board.
Depending on the surgeon's preference, the patient's legs would ~22~

either be maintained in their current, straight, position to maintain the dorsal recumbent position D, or they would be positioned in Allen stirrups to provide the lithotomy position L
similar to that in which a pelviscopy is performed. The patient is prepared with an antiseptic solution over the intended incisional area or surgical site. Cloth towels are draped to isolate that area, and cholecystectomy drape 70 is placed to position the registration area, or the suprapubic access area, of aperture 74, located above the middle of lower edge 80 of aperture 74, just below the umbilicus. If the patient's legs are in the lithotomy position L, bottom section 72 of drape 70 is placed between the patient/s legs. If the patient is maintained in a dorsal recumbent, or flat, position D, drape 70 would cover the patient's legs and the bottom of the surgical table. Thus, the width of lower section 72 of cholecystectomy drape 70 is wider than lower section i8 of pe]viscopy drape 70, to enable cholecystectomy drape 70 to be useful whether the surgeon prefers the lithotomy position L or the dorsal recumbent position D.
Upper section 90 of drape 70 covers the patient's arms if they are tucked at the sides or it would cover the left arm, which is extended on an arm board and the right arm, which is tucked at the side.

The first 10 mm. incision 120 is made beneath the umbilicus near corner 96 of opening 74. The first and second 5 mm. incisions 122 and 124 are made lateral to the umbilicus between corners 94 and 97. The second 10 mm. puncture 126 is 2 ~

made in the left lateral quadrant of the patient, or slightly to the right of midline of the abdomen, near corner 9B. The precise spacing among the 5 and 10 mm. incisions 120, 122, 124 and 126 again depends on the size and weight of the patient. However, the size, shape and placement of opening 74 permits use of drapes 70 during laparoscopic cholecystectomies performed on all sizes and weights of patients.

Claims (12)

THE EMBODIMENTS OF THE INVENTION IN WHICH AN EXCLUSIVE
PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:

1. A surgical drape for covering a patient during surgery to define a sterile field comprising a sheet of flexible material defining an opening providing access to a surgical site during the performance of surgery on the patient, said opening defining a registration area that can be positioned at the site of the suprapubic incisions to position said opening properly on the patient's abdomen, the width of said opening decreasing with distance from said registration area, said sheet including a water resistant or waterproof zone surrounding said opening, whereby said opening provides a wider effective surgical site for heavier patients while maintaining an effective sterile field for smaller patients.

2. The drape recited by claim 1 wherein said opening is formed in the shape of a triangle, the area above the base of said triangle constituting said registration area.

3. The drape recited by claim 2 wherein said sheet defines a wider section and a narrower section, said opening and water resistant or waterproof zone being located on said wider section.

4. The drape recited by claim 3 wherein said narrower section defines a rectangular perineal opening.

5. The drape recited by claim 4 further including a hem formed on the edges of each said opening.

6. A surgical drape for covering a patient during surgery to define a sterile field comprising a sheet of flexible material defining an access area that can be positioned at the suprapubic area of the patient and through which incisions can be made in the suprapubic area of the patient, and an umbilical access area that provides access to the umbilical area of the patient when the suprapubic access area is positioned over the suprapubic area of the patient, said suprapubic access area permitting the formation of at least two suprapubic access incisions.

7. A surgical drape for covering a patient during performance of a laparoscopic cholecystectomy to define a sterile field comprising a sheet of flexible material defining an umbilical access area through which an incision can be made near the umbilicus of a patient and at least two additional incisions can be made lateral to the umbilical incision in the subcostal area, and a lateral quadrant access area through which an incision can be made in the right lateral quadrant of the patient.

8. The drape recited by claim 7 wherein said access areas are defined by a single opening.

9. The drape recited by claim 8 wherein a hem is formed on the edge of said opening.

10. The drape recited by claim g wherein a water resistant or waterproof zone is formed around said opening.

11. The drape recited by claim 10 wherein said sheet defines a wider section and narrower section, said opening and water resistant or waterproof zone being located in said wider section.

12. A surgical drape for covering a patient during the performance of laparoscopic cholecystectomies to define a sterile field comprising a sheet of flexible material defining an opening providing access to a surgical site during the performance of the cholecystectomy, said opening defining a registration point that can he positioned at a the umbilicus of the patient to position said opening properly on the abdomen of the patient, said opening defining an area above said registration point that permits access to the right lateral quadrant of the patient, and a subcostal area that provides access to the subcostal area of the patient.