Closure method for use in laparoscopic surgery

A method for use in laparoscopic surgery comprises the steps of disposing a laparoscopic trocar sleeve in an abdominal wall of a patient so that the sleeve traverses an opening in an abdominal skin surface of the patient and also traverses an underlying aperture in a peritoneum of the patient and providing a closure device having an elongate shaft and a distal end portion made of bioabsorbable material. The trocar sleeve is removed from the abdominal wall of the patient and at least part of the closure device is inserted through the skin surface opening so that the distal end portion of the closure device is partially disposed proximately to the aperture in the peritoneum. The skin surface opening is at least partially closed subsequently to the removal of the trocar sleeve and the insertion of the closure device. The closure device is maintained in a position at least partially traversing the abdominal wall of the patient so that the distal end portion of the closure device remains partially disposed proximately to the aperture so as to block entry of an abdominal organ into the aperture subsequently to the closure of the opening in the skin surface.

BACKGROUND OF THE INVENTION 
This invention relates to a method for use during a laparoscopic surgical 
procedure. More particularly, this invention relates to a closure 
technique for use during a laparoscopic surgical procedure. 
Laparoscopy involves the piercing of a patient's abdominal wall and the 
insertion of a cannula through the perforation. Generally, the cannula is 
a trocar sleeve which surrounds a trocar during an abdomen piercing 
operation. Upon the formation of the abdominal perforation, the trocar is 
withdrawn while the sleeve remains traversing the abdominal wall. A 
laparoscopic instrument, such as a laparoscope or a forceps, is inserted 
through the cannula so that a distal end of the instrument projects into 
the abdominal cavity. 
Generally, in a laparoscopic surgical procedure, three or four perforations 
are formed in the abdomen to enable deployment of a sufficient number of 
laparoscopic instruments to perform the particular surgery being 
undertaken. Each perforation is formed by a trocar which is surrounded by 
a sleeve, the sleeves or cannulas all remaining in the abdominal wall 
during the surgical procedure. 
Prior to insertion of the first trocar and its sleeve, a hollow needle is 
inserted through the abdominal wall to enable pressurization of the 
abdominal cavity with carbon dioxide. This insufflation procedure distends 
the abdominal wall, thereby producing a safety space above the patient's 
abdominal organs. 
Laparoscopic surgery provides several advantages over conventional 
incision-based surgery. The laparoscopic perforations, in being 
substantially smaller than the incisions made during conventional 
operations, are less traumatic to the patient and provide for an 
accelerated recovery and convalescence. Hospital stays are minimized. 
Concomitantly, laparoscopic surgery is less time consuming and less 
expensive than conventional surgery for correcting the same problems. 
Laparoscopic surgery is frequently performed to remove a malfunctioning 
organ such as a gall bladder filled with stones. Generally, a severed 
bladder is removed from the patient's abdomen by drawing the organ against 
the distal end of the trocar sleeve and then withdrawing the trocar sleeve 
with the bladder entrained thereto. 
Occasionaly, a complication resulting from laparoscopic surgery is a 
hernia. A portion of bowel becomes wedged in an aperture left in the 
peritoneum of the patient upon withdrawal of the trocar sleeve. A need 
exists for a method to prevent or obviate hernias resulting from 
laparoscopic surgery. 
OBJECTS OF THE INVENTION 
An object of the present invention is to provide a method for use in 
laparoscopic surgery which reduces, if not eliminates, the subsequent 
incidences of hernias. 
Another, more particular, object of the present invention is to provide a 
laparoscopic closure technique for use in closing abdominal openings 
formed during laparoscopic surgery by trocars and associated sleeves. 
A further particular object of the present invention is to provide such a 
method which is relatively easy to execute. 
These and other objects of the present invention will be apparent from the 
drawings and detailed descriptions herein. 
SUMMARY OF THE INVENTION 
A method for use in laparoscopic surgery comprises the steps of (a) 
disposing a laparoscopic trocar sleeve in an abdominal wall of a patient 
so that the sleeve traverses an opening in an abdominal skin surface of 
the patient and also traverses an underlying aperture in a peritoneum of 
the patient, (b) providing a closure device having an elongate shaft and a 
distal end portion made of bioabsorbable material, (c) removing the trocar 
sleeve from the abdominal wall of the patient, (d) inserting at least part 
of the closure device through the skin surface opening so that the distal 
end portion of the closure device is partially disposed proximately to the 
aperture in the peritoneum, (e) at least partially closing the skin 
surface opening subsequently to the removal of the trocar sleeve and the 
insertion of the closure device, and (f) maintaining the closure device at 
least partially traversing the abdominal wall of the patient so that the 
distal end portion of the closure device remains partially disposed 
proximately to the peritoneal aperture so as to block entry of an 
abdominal organ into the aperture subsequently to the closure of the 
opening in the skin surface. 
Pursuant to another feature of the present invention, the distal end 
portion of the closure device includes an expandable element and the 
method further comprises the step of expanding the expandable element 
after the closure device is inserted through the opening in the skin 
surface of the patient. Preferably, the expandable element is a balloon 
which is inflated upon insertion of the closure device into the abdominal 
wall. 
According to a further feature of the present invention, the shaft of the 
closure device is severed at a point between the skin surface opening and 
the peritoneal aperture prior to the closure of the skin surface opening. 
Where the distal end portion of the closure device includes an expandable 
element, that element is preferably expanded prior to the severing of the 
shaft of the closure device. 
According to a particular feature of the present invention, the insertion 
of the closure device is performed prior to the removal of the trocar 
sleeve. More particularly, the closure device is inserted into the trocar 
sleeve so that a proximal end segment of the shaft remains outside the 
patient. 
According to another particular feature of the present invention, the 
removal of the trocar sleeve is implemented by grasping the proximal end 
segment of the closure device shaft and simultaneously pulling the trocar 
sleeve from the abdominal wall of the patient. 
Pursuant to another feature of the present invention, a part of the shaft 
of the closure device (e.g., a head on the shaft) remains outside of the 
patient upon closure of the opening in the patient's abdominal skin 
surface. 
A method in accordance with the present invention for use in laparoscopic 
surgery reduces, if not eliminates, the incidence of hernias at trocar 
sleeve insertion sites. The method is relatively easy to execute.

DETAILED DESCRIPTION 
As illustrated in FIG. 1, in a laparoscopic surgical procedure a trocar 
sleeve 12 provided at a proximal end with a schematically represented port 
element 14 is disposed in an abdominal wall AW1 of a patient so that the 
sleeve traverses an opening 16 formed in a skin surface SS1, a hole 18 
formed in a fascia layer FL1, and an aperture 20 formed in an underlying 
peritoneum layer PL1 of a patient P. The distal end of trocar sleeve 12 
projects into an abdominal cavity AC of the patient. At the onset of the 
laparoscopic procedure, trocar sleeve 12 is inserted with the aid of a 
trocar (not shown) upon insufflation of abdominal cavity AC with a Veress 
needle (not shown). 
In order to effectively close aperture 20 to prevent a hernia due to 
intestine or another internal organ creeping into aperture 20 after the 
termination of the laparoscopic procedure, a distal end portion 22 of a 
closure device 24 is positioned in the abdominal hole defined by opening 
16, hole 18 and aperture 20. Distal end portion 22 of closure device 24 
comprises an inflatable balloon 26 made of a bioabsorbable material. 
Inflatable balloon 26 is mounted to a tubular shaft 28 also made of a 
bioabsorbable material. Balloon 26 communicates via shaft 28 with a source 
30 of pressurized carbon dioxide, saline solution or another biocompatible 
fluidic agent. 
Upon the removal of trocar sleeve 12 from abdominal wall AW1 at the 
termination of a laparoscopic procedure, distal end portion 22 of closure 
device 24 is inserted through opening 16 in skin surface SS1 so that 
distal end portion 22 is partially disposed proximately to aperture 20 in 
peritoneum PL1. During the insertion of distal end portion 22 of closure 
device 24, balloon 26 is in a deflated state. Upon a proper positioning of 
balloon 26 via shaft 28, pressure source 30 is connected to balloon 26 
(e.g., via a non-illustrated valve) to inflate the balloon as shown in 
FIG. 2. Subsequently, a proximal end portion of shaft 28 is severed at 32, 
below skin surface SS1. Opening 16 is then closed with sutures 34. Upon 
inflation, balloon 26 is maintained in a position at least partially 
traversing abdominal wall AW1 so that distal end portion 22 remains 
partially disposed proximately to aperture 20 so as to block entry of an 
abdominal organ (not shown into the aperture subsequently to the closure 
of opening 16 in skin surface SS1. 
FIGS. 3A-3D illustrate an equivalent method for the closure of an aperture 
35 formed in a pertoneal layer PL2 of an abdominal wall AW2 by a trocar 
sleeve 36. A closure device 38 comprising a tubular shaft 40 and a 
deflated balloon 42 is inserted through sleeve 36 so that balloon 42 is 
located inside the sleeve approximately at the level of abdominal wall AW2 
(FIG. 3A). Trocar sleeve 26 is then removed from abdominal wall AW2, as 
indicated by an arrow 44 in FIG. 3B, while balloon 42 is maintained at the 
same level. 
Upon the removal of sleeve 26 from abdominal wall AW2, tubular shaft 40 is 
connected to a pressure source 46, e.g., a hypodermic type syringe, as 
illustrated in FIG. 3C. Pressure source 46 is activated to inflate balloon 
42, thereby blocking access to aperture 35 in peritoneal layer PL2. Upon 
the pressurization of balloon 42, shaft 40 is severed below a skin surface 
SS2 of abdominal wall AW2 through utilization of a cutting forceps 50, as 
illustrated in FIG. 3D. The cutting action also serves to crimp shaft 40 
closed and prevent the escape of pressurizing fluid from balloon 42. 
Alternatively, shaft 40 may be provided at balloon 42 with a one-way valve 
(not shown) for preventing the exit of pressurizing fluid from balloon 42 
upon the expansion thereof. Balloon 42, as well as at least a distal end 
portion of shaft 40, is made of a bioabsorbable material, as discussed 
hereinabove with reference to FIG. 2. 
Upon the severing of shaft 40, an opening 52 in skin surface SS2 is closed, 
for example, by sutures or staples. Balloon 42 remains inflated long 
enough to prevent the insertion of intestinal loops through aperture 35 
while the organic tissues of skin surface SS2, a fascia layer FL2 and 
peritoneal layer PL2 are healing. Subsequently, balloon 42 and the distal 
end portion of shaft 40 are absorbed into the patient's body. 
FIG. 4A shows another closure device 54 for possible use in the methods 
described hereinabove with reference to FIGS. 2 and 3A-3D. Closure device 
54 comprises a central shaft 56 to which a plurality of fingers or spokes 
58 are fixed. Shaft 56 is inserted inside a tube 60 so that spokes 58 are 
bent into a roughly parallel configuration with respect to shaft 56 and 
tube 60. Tube 60 thus serves as a temporary retainer for holding spokes 58 
in a collapsed configuration in opposition to spring biasing forces 
tending to return spokes 58 to a radial configuration shown in FIG. 4B. 
Spokes 58 and at least a distal end portion of shaft 56 are made of a 
bioabsorbable material. 
Upon the removal of a trocar sleeve 62 (FIG. 4A) from an aperture 64 (FIG. 
4B) in a peritoneal layer PL3, a hole 66 in a fascia layer FL3, and an 
opening 68 in an overlying skin surface or layer SS3, a distal end of 
closure device 54 is inserted through opening 68 so that a distal tip or 
head 70 of shaft 56 is disposed at the level of peritoneal layer PL3. Tube 
60 is then removed from about shaft 56, allowing spokes 58 to expand into 
the radial configuration of FIG. 4B wherein the spokes are inserted into 
and/or between layers SS3, FL3 and PL3, thereby holding shaft 56 and 
spokes 58 of closure device 54 in position to prevent the entrance of 
intestinal and other organ parts through aperture 64. Subsequently to the 
expansion of spokes 58 and the proper disposition of shaft 56 relative to 
hole 66, opening 68 and aperture 64, shaft 56 is severed below skin 
surface or layer SS3 and opening 68 is closed via sutures or staples 70. 
The device of FIGS. 4A and 4B can also be used in a method according to 
FIGS. 3A-3D wherein shaft 56 and optionally tube 60 are sufficiently long 
to enable the insertion of the distal end portion thereof into trocar 
sleeve 62 and the removal of the sleeve from the patient while shaft 56 is 
grasped to maintain proper positioning thereof. In this procedure, shaft 
56 (and optionally tube 60) is grasped first at a proximal end during 
removal of sleeve 62 from the abdominal wall AW3 (see FIG. 4B) of the 
patient. Subsequently, if sleeve 62 is to be removed from around shaft 56 
prior to the severing thereof, shaft 56 and tube 60 may be grasped at a 
median point. 
As depicted in FIG. 5, another closure device for use in the method 
described hereinabove with reference to FIG. 2 or FIGS. 3A-3D includes a 
shaft 72 to which a plurality of spokes or radial ribs 74 are attached in 
one or more spaced arrays (as in FIGS. 4A and 4B). A flexible web 76 is 
attached to spokes or ribs 74. A distal end portion of shaft 72, ribs 74 
and web 76 are made of a bioabsorbable material. The closure device of 
FIG. 5 is inserted into a retainer tube such as tube 60 of FIG. 4A for 
installation in a patient's abdominal wall at the end of a laparoscopic 
procedure. 
FIG. 6 shows yet another closure device 78 for use in the method described 
hereinabove with reference to FIG. 2. Closure device 78 is in the form of 
a tube or shaft 80 with a head 82. Upon the withdrawal or extraction of a 
trocar sleeve (not shown in FIG. 6) from an abdominal wall AW4 and 
particularly from an aperture 84 in a peritoneal layer PL4, a hole 86 in a 
fascia layer FL4, and an opening 88 in an overlying skin surface or layer 
SS4, shaft 80 of closure device 76 is inserted through opening 88 so that 
a distal tip 90 of shaft 78 is disposed at the level of peritoneal layer 
PL4 and so that head 82 remains outside skin surface SS4. Opening 88 is 
then partially closed, e.g., with sutures or staples 94. Subsequently, 
after some healing and tissue growth has occurred, head 82 may be severed 
from shaft 78 and opening 88 completely closed. Shaft 80 may be provided 
at a free end with a flange or head 92 for facilitating the blocking 
function of closure device 78. 
Although the invention has been described in terms of particular 
embodiments and applications, one of ordinary skill in the art, in light 
of this teaching, can generate additional embodiments and modifications 
without departing from the spirit of or exceeding the scope of the claimed 
invention. Accordingly, it is to be understood that the drawings and 
descriptions herein are profferred by way of example to facilitate 
comprehension of the invention and should not be construed to limit the 
scope thereof.