Surgical apparatus

An improved surgical apparatus for hand-assisted minimum invasive surgery with isolation at the site of a wound from ambient conditions. A sleeve of gas-impermeable material includes entry and exit openings for access to the wound, and ports for introducing surgical instruments into the sleeve within easy reach of a surgeon's hand.

FIELD OF INVENTION 
The present invention relates generally to apparatus for use in surgery, 
and more particularly to improvements in surgical apparatus suitable for 
maintaining a sterile aseptic environment while performing open or minimum 
invasive surgery. 
BACKGROUND OF THE INVENTION 
Laparoscopic surgery has become a procedure of choice for certain abdominal 
operations because of the relatively small incisions involved and the 
minimal trauma and shortened healing time for the patient. However, not 
all surgeons have the highly specialized training and experience needed to 
perform the required critical surgical tasks with trocar and cannula 
assemblies while observing a remote TV image of the abdominal cavity under 
conditions of pneumoperitoneum. 
A modified or hybrid form of laparoscopic surgery, more adaptable to 
surgeons trained only in conventional surgical techniques, is now possible 
with a surgical apparatus especially developed for hand-assisted minimum 
invasive laparoscopic surgery while still maintaining pneumoperitoneum. 
The mere presence of one hand of the surgeon in the abdominal cavity 
together with a laparoscope enables the trocar and cannula assemblies to 
be precisely and safely moved about by feel as well as by sight on a TV 
monitor. 
Such an apparatus is disclosed in pending U.S. patent application Ser. No. 
08/300,346 filed Sep. 2, 1994 by the inventors of the present invention. A 
flexible sleeve with an entry opening at the proximal end is sealed by an 
adjustable cuff around the surgeon's forearm when his/her hand is inserted 
into the sleeve, and an exit opening on one side near the distal end of 
the sleeve is sealed by an adhesive flange around an incision through 
which the surgeon's hand may pass into the abdominal cavity. A duckbill 
check valve located between the entry and exit openings defines an 
antechamber along the forearm which prevents loss of pneumoperitoneum 
while the hand is being inserted or removed from the sleeve during a 
surgical procedure such as when retrieving various surgical instruments. 
However, the apparatus does not permit the surgeon or other operating room 
personnel to introduce or remove instruments directly into the sleeve at 
the site of the incision during an operation, or to store these 
instruments within the sleeve where they can be easily grasped by the 
surgeon; nor will the apparatus enable the surgeon to use both hands, or 
the hand of an assistant, within the sleeve. 
Furthermore, brief interruptions in the course of an operation may not be 
feasible where the surgeon needs to withdraw his/her arm from the sleeve 
from time to time. 
SUMMARY OF THE INVENTION 
Accordingly, it is an object of the present invention to provide a surgical 
apparatus suitable for open or minimum invasive surgery while maintaining 
a sterile aseptic environment at the operating site. 
Another object of the invention is to provide a gas-impervious sleeve for 
hand-assisted surgery in which conventional instruments can be inserted 
under conditions of pneumoperitoneum within easy reach of the surgeon's 
hand. 
Still another object of the invention is to provide a surgical apparatus 
which is suitable for hand-assisted surgery under conditions of 
pneumoperitoneum, and which can be quickly disconnected and reconnected 
around the site of an incision to accommodate brief interruptions in the 
course of an operation. 
A still further object of the invention is to provide a surgical apparatus 
suitable for maintaining a sterile aseptic environment in the immediate 
vicinity of a wound during a surgical procedure initiated under emergency 
conditions at a field station and subsequently while the patient is being 
transported to a more fully equipped aseptic operating room environment 
where the surgical procedure can be completed. 
These and other objects and novel features of the invention are 
accomplished with a surgical apparatus in which a flexible sleeve includes 
an exit opening near a distal end for adhesively sealing around an 
incision in a patient, and sealable hand and instrument entry openings for 
maintaining an isolated and aseptic environment in the immediate vicinity 
of the incision. One preferred embodiment includes access ports with 
duckbill check valves in the sleeve near the incision which allow 
laparoscopic and other surgical instruments to be introduced or removed 
from the sleeve without losing pneumoperitoneum or sterile integrity at 
the site. In a second embodiment, two sleeves communicate with a 
transparent dome-shaped envelope for receiving both hands. The envelope is 
completely closed except for an opening in the bottom side which 
adhesively seals to the patient around the operating site, and access 
ports with duckbill check valves extending into the top of the envelope 
for instruments to be passed in and out during surgery. A third embodiment 
includes a short sleeve with a quick-disconnect ring and an adhesive 
flange at a distal end opening which seal around the outer end of a wound 
protector emplaced in the incision. A cuff at the proximal end opening 
seals the sleeve around the arm of the surgeon, and instrument access 
ports with duckbill check valves maintain pneumoperitoneum and sterile 
integrity at the incision while the sleeve is connected to the wound 
protector during surgery.

DESCRIPTION OF THE PREFERRED EMBODIMENTS 
Referring now to the drawings wherein like reference characters denote like 
or corresponding parts throughout the several views, there is shown in 
FIGS. 1, 2 and 3 a surgical apparatus, indicated generally by the numeral 
10, adhering to a patient's abdominal wall L. Of course, if a surgical 
drape were first applied to the operating site, flange 18 would adhere as 
well to the upper surface of the drape around a wound W. 
Apparatus 10 includes a gas-impermeable, flexible sleeve 12 having a distal 
end 12a with an exit opening 14 in a bottom panel 12c around wound W sized 
to pass a surgeon's hand through, and a proximal end 12b with an entry 
opening 16 remote from the site sized to pass the surgeon's hand through 
and receive the forearm. A flange 18, fixed to panel 12c around exit 
opening 14, is coated on the bottom exposed side with an adhesive 19 for 
adhering to the abdominal wall L. A release or peel-strip backing (not 
shown) completely covers the adhesive prior to use. A non-toxic, 
biocompatible adhesive found especially suitable for hypersensitive skin 
is an acrylate polymer, such as IT8-59-A by Tolas Health Care Packaging of 
Feasterville, Pa., having a thickness of 0.002 in., peel adhesion 8 to 10 
lb/sq. in., shear resistance of 1.2 hrs. at 1 kg/sq.in., and tack 1250 
g/sq. cm. around wound W. An adjustable cuff 20 in entry opening 16 clamps 
around the forearm to form a chamber in sleeve 12 communicating with the 
abdominal cavity. An inner gas-lock or duckbill check valve 22 biased 
normally closed by a bias stay 23, defines an antechamber in sleeve 12 
with cuff 20 around the surgeon's arm to minimize loss of insufflation 
under conditions of pneumoperitoneum when cuff 20 is breached. Sleeve 12, 
valve 22 and cuff 20 are preferably constructed of 3-mil polyolefin with 
flange 18 of 4-mil polyolefin materials and in the manner such as 
disclosed in patent application Ser. No. 08/300,346, supra, the disclosure 
of which is incorporated by reference herein. 
Access ports 24 and 26, located near exit opening 14 in a top panel 12d of 
sleeve 12 allow instruments or the like to be inserted during surgery 
while maintaining pneumoperitoneum. As best seen in FIG. 2, port 24 
defines an opening 24a located approximately coaxial with exit opening 14 
and includes a duckbill check valve 24b extending into sleeve 12. An 
external snap-on cap 24c covers opening 24a when not in use. Access port 
26 defines a slot 26a transverse to the length of sleeve 12 between port 
24 and distal end 12a and includes a duckbill check valve 26b extending 
into sleeve 12. A grommet 26c fixed around slot 26a provides stiffening 
and tear resistance, and a strip 26d coated on one side with a peelable 
adhesive 26e sealingly adheres to the exposed surface of grommet 26c. On 
account of the width of duckbill check valve 26a, tension is applied 
between the opposite sides thereof by a U-shaped stay 26f made of a thin 
strip of resilient material, such as a high density polyethylene plastic, 
in order to maintain valve 26a in a normally closed position. Port 24 is 
sized to pass slender instruments such as lumens and trocars, whereas port 
26 is sized to pass wider instruments such as clamps and forceps. The 
duckbill configuration of the check valve 24 and 26 comprises two flexible 
flat panels joined to each other on opposite sides and around the 
respective specimens 24a and 26a. 
A wound protector 28, such as disclosed in patent application Ser. No. 
8/300,346, supra, and incorporated by reference herein emplaced in exit 
opening 16 and extending through abdominal wall L and peritoneum P, 
protects wound W from exposure to diseased tissue and non-sterile material 
passing through the wound during surgery. 
Referring now to FIG. 4, there is shown a surgical apparatus, indicated 
generally by the numeral 30, which is especially suitable for obtaining an 
asceptic environment in the immediate vicinity of wound W for performing 
emergency abdominal surgery such as at a mobile field hospital. Apparatus 
30 comprises a flexible enclosure 32 made of a generally flat bottom panel 
32a covered by a dome-shaped top panel 32b. An exit opening 34 in bottom 
panel 32a includes an adhesive flange for sealing to surgical drape D 
around an aforedescribed wound protector 28 emplaced in wound W. A distal 
end of flexible left and right sleeves 38a and 38b, respectively, 
communicate with the interior of enclosure 32 through openings in top 
panel 32b on generally opposite sides thereof. Entry openings 40 at 
proximal ends of sleeves 38a and 38b each includes an aforedescribed 
adjustable cuff 20 which tightens around the surgeon's forearms and 
completely isolates wound W from ambient conditions. 
Top panel 32b of enclosure 32 includes access ports 44 constructed like 
access port 24 of FIG. 2 for passing instruments through to the surgeon. 
The size of the port is determined according to the size and shape of the 
instruments. In addition, pockets 46 affixed to the interior of top panel 
32b are provided for storing instruments and other devices at easily 
accessible locations. The shape of the pockets depend on the type of 
device stored. 
Top panel 32b is preferably made of a thin transparent plastic film to give 
the surgeon a clear view of the operating site. Apparatus 30 being made of 
flexible material allows the surgeon in a field emergency situation to 
close wound W temporarily and roll up sleeves 38a and 38b, as shown in 
broken outline, thereby sealing enclosure 32 for transporting the patient 
to another facility with apparatus 30 attached where the surgery can be 
completed under better conditions. Elastic bands or clips, not shown, may 
be applied to keep the sleeves from unrolling. 
Referring now to FIG. 5, there is shown a surgical apparatus, indicated 
generally by the numeral 50, for hand-assisted minimum invasive surgery 
under conditions of pneumopentoneum which can be readily connected and 
disconnected by the surgeon during the operation. Apparatus 50 comprises a 
sleeve 52 having an entry opening 54 at a proximal end which is tightened 
around a surgeon's forearm by an adjustable cuff 20 as described in FIG. 
1. An elastic ring 56 at the distal end of sleeve 52 defines an annular 
lip 56a with an interference fit with an exposed O-ring 28a of a wound 
protector 28 which has been emplaced in wound W in the manner described in 
patent application Ser. No. 08/300,346, supra, the disclosure of which is 
incorporated by reference herein. Protector 28 includes a flexible tube 
28b secured around one end of O-ring 28a and around an O-ring 28c at the 
opposite end. An adhesive-coated flange 58 about ring 56 adheres to 
surgical drape D to sealingly enclose sleeve 52 about the wound. 
Ports 60 and 62 provide direct access for instruments to be inserted into 
sleeve 52 without losing insufflation pressure, if any is present. Port 60 
is constructed with check valves 60b and snap-on cap 60c in the same 
manner as port 24 of FIG. 1. Port 62 is preferably constructed of a 
semi-rigid sleeve 62a communicating at one end through an opening 62b in 
sleeve 52. A duckbill valve 62c extends toward opening 62b from an O-ring 
62d secured around the other end of sleeve 62a. 
The method of using the several disclosed embodiments of the surgical 
apparatus are similar. Basically, the abdomen is routinely prepared with 
anteseptics and dried, and an incise drape D is applied to the operating 
site. An incision with a scalpel is made at the site of sufficient size 
for a surgeon's hand to pass through. A wound protector 28 corresponding 
in size with the incision is placed in the wound by squeezing one O-ring 
into a tight ellipse and inserting it lengthwise through the incision 
until it expands inside the peritoneum and the O-ring on the other end 
overlaps the exposed drape D around wound W. With the surgeon's hand 
extending into the abdominal cavity through the wound protector 28, 
trocars/cannulas may be guided into place and the hand removed in order to 
attach one of the above-described surgical apparatus 10, 30, or 50. The 
hand is then reinserted through the openings of the apparatus for drawing 
outer O-ring through opening 14 and allowing it to expand inside sleeve 12 
around the opening, and the cavity insufflated. Instruments and other 
materials may then be inserted within easy reach of the surgeon's hand 
through the various ports, or may be stored in pockets within the 
apparatus. 
Another simplified embodiment is illustrated in FIG. 6. As seen therein, a 
surgical apparatus 200 similar in construction to apparatus 100 of FIGS. 
3-17 in Applicants' incorporated by reference copending application Ser. 
No. 300,346, now U.S. Pat. No. 5,640,977 is provided, except that a first 
flange 251 is integral with a proximal end 204 of a sleeve 202, and a 
second flange member 252 is integral with a surgeon's glove 253 having a 
hand and finger receiving portion 253a and an elongate gauntlet portion 
253b mounting the second flange 252 in the region of the open end thereof. 
When the surgeon's arm with glove 253 passes into sleeve 202, flanges 251 
and 252 are sealingly interengaged. FIG. 7 illustrates the embodiment of 
FIG. 6 in use in surgery. As seen therein, the inner glove 253 extends 
interiorily of the sleeve 202 and is connected thereto at the sleeve 
proximal end 204 to afford a range of arm movement of the surgeon relative 
to the patient under insufflation conditions of the patients's cavity. An 
adhesive coated ring 211, as described heretofore, and in the parent 
application, extends around the wound W for effecting a sealed gastight 
connection of the outer sleeve 202 onto the patient over which a 
conventional surgical drape D is installed. 
Some of the many advantages and novel features of the invention should now 
be readily apparent. For example, a surgical apparatus is provided which 
is especially suitable for open or minimum invasive surgery while 
maintaining a sterile asceptic environment at the operating site. Ports 
with duckbill check valves are provided in the apparatus which allow 
instruments of various shapes and sizes to be inserted under conditions of 
pneumoperitoneum and within easy reach of the surgeon's hand. The 
apparatus can be quickly disconnected and reconnected around the site of 
an incision to accommodate brief interruptions in the course of an 
operation. In one of the disclosed embodiments, the apparatus can remain 
attached to the patient while being transferred from a field hospital to a 
more complete operating room facility where the surgery can be completed. 
It will be understood, of course, that various changes in the details, 
materials, steps and arrangement of parts, which have been herein 
described and illustrated in order to explain the nature of the invention 
may be made by those skilled in the art within the principal and scope of 
the invention as expressed in the appended claims.