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Patent 2062227 Summary

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Claims and Abstract availability

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(12) Patent Application: (11) CA 2062227
(54) English Title: SURGICAL DRAPE
(54) French Title: CHAMP STERILE CHIRURGICAL
Status: Dead
Bibliographic Data
(51) International Patent Classification (IPC):
  • A61B 46/23 (2016.01)
  • A61B 46/00 (2016.01)
(72) Inventors :
  • BRONITSKY, CARL (United States of America)
  • STUCKEY, SUSAN J. (United States of America)
(73) Owners :
  • BRONITSKY, CARL (United States of America)
  • STUCKEY, SUSAN J. (United States of America)
(71) Applicants :
(74) Agent: BORDEN LADNER GERVAIS LLP
(74) Associate agent:
(45) Issued:
(22) Filed Date: 1992-03-03
(41) Open to Public Inspection: 1992-09-07
Availability of licence: N/A
(25) Language of filing: English

Patent Cooperation Treaty (PCT): No

(30) Application Priority Data:
Application No. Country/Territory Date
665,527 United States of America 1991-03-06

Abstracts

English 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.

-27-


Claims

Note: Claims are shown in the official language in which they were submitted.


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.



-24-


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.



-25-

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.

-26-


Description

Note: Descriptions are shown in the official language in which they were submitted.


~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.


2~22~

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.
--4--


2n~


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 ~
.

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
---- -- -- - -- . ... .

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.


:


--8--

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


S7


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:




--10--


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

:
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




-12-

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.


2 0 ~


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,




-14-

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:



A- 99 1/4
B- 57 1/4
C- 43
D- 14
E- 10
~- 31
G- 40 1/4
H- 6
I- 2 1/2
J- 44 1/2
K- 33 1/2
L- 37 1/4
M- 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



-16-

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.




-18-

2 ~ Y~

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,




--19--

2 2 ~
; .

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,
E- 41
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



-20-

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




-21-

~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




-22-

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.




-23-

Representative Drawing
A single figure which represents the drawing illustrating the invention.
Administrative Status

For a clearer understanding of the status of the application/patent presented on this page, the site Disclaimer , as well as the definitions for Patent , Administrative Status , Maintenance Fee  and Payment History  should be consulted.

Administrative Status

Title Date
Forecasted Issue Date Unavailable
(22) Filed 1992-03-03
(41) Open to Public Inspection 1992-09-07
Dead Application 1996-09-03

Abandonment History

There is no abandonment history.

Payment History

Fee Type Anniversary Year Due Date Amount Paid Paid Date
Application Fee $0.00 1992-03-03
Maintenance Fee - Application - New Act 2 1994-03-03 $50.00 1994-02-23
Maintenance Fee - Application - New Act 3 1995-03-03 $50.00 1995-03-03
Owners on Record

Note: Records showing the ownership history in alphabetical order.

Current Owners on Record
BRONITSKY, CARL
STUCKEY, SUSAN J.
Past Owners on Record
None
Past Owners that do not appear in the "Owners on Record" listing will appear in other documentation within the application.
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Document
Description 
Date
(yyyy-mm-dd) 
Number of pages   Size of Image (KB) 
Description 1992-09-07 23 823
Drawings 1992-09-07 4 100
Claims 1992-09-07 3 99
Abstract 1992-09-07 1 11
Cover Page 1992-09-07 1 17
Fees 1995-03-03 1 66
Fees 1994-02-23 1 50