Method for performing a gastric wrap of the esophagus for use in the treatment of esophageal reflux

The invention provides a method of fundoplication of the stomach to the esophagus comprising introducing an esophageal manipulator (72) into the stomach lumen (10), maneuvering the manipulator within the lumen so as to create an intussusception (48) of the esophagus (14) into the stomach, introducing a stapler (68) to the lumen of the stomach, and stapling the intussuscepted esophagus to the stomach operation of the stapler is from within the lumen of the stomach. The invention also provides a medical or surgical stapler comprising an elongated body (80) having a passageway (70) which is adapted to receive a medical component such as a forceps (72) or fluid.

BACKGROUND OF THE INVENTION 
Gastroesophageal reflux (GER) is a major problem with serious consequences 
in both the pediatric and adult population. GER includes reflux or 
regurgitation of stomach contents up into the esophagus. Occasionally the 
stomach contents, including acids, are aspirated into the pulmonary tree. 
GER is especially serious in infants, but many adults are also troubled 
with the symptoms. Frequent complications include esophagitis and 
esophageal stricture, intractable vomiting, asthma, and aspiration 
pneumonia. In infants and children GER has been associated with a wide 
spectrum of symptoms including vomiting, failure to thrive, recurrent 
aspiration pneumonia, apnea, sudden infant death syndrome, and brain 
damage. There is also a high incidence of GER in patients who have 
undergone correction of esophageal atresia or abnormal esophageal 
narrowing. 
The gastroesophageal junction (GEJ) is an anatomical region including the 
junction of the stomach and esophagus. The GEJ combined with the lower 
esophageal sphincter (LES) forms a valve between the stomach and 
esophagus. The LES is formed of circular bands of muscle at the distal 
esophagus near the stomach. Incompetence of the valve contributes to 
symptoms of GER. In the last three decades improved understanding of the 
pathophysiology of GER has led to development of a variety of surgical 
procedures designed to construct a competent valve at the GEJ. Although 
usually effective, all are associated with significant morbidity and the 
risk of recurrence. 
Fundoplication is a surgical treatment for GER. This corrective surgery 
typically involves a major operation with a large incision to expose the 
stomach and lower esophagus. Without penetrating the stomach, the 
esophagus is pulled down below the hole in the diaphragm through which the 
esophagus is normally admitted. Then a portion of the stomach, the fundus, 
is plicated or gathered up and wrapped around the distal end of the 
esophagus and sewn in place from the outside of the stomach and esophagus. 
FIG. 1a is a schematic of a conventional fundoplication of a stomach 2 to 
an esophagus 4. Suture line 6 represents surgical fixation of folds 8 to 
create the fundoplication. Folds 8 are in the fundal region of stomach 2. 
Folding the fundus up and around the distal end of esophagus 4 forms the 
fundoplication. The stomach lumen 10 is not entered. Suture line 6 holds 
folds 8 in place; it does not represent repair of a gastric incision. 
Some current anti-reflux procedures are the Nissen, Thal, and Belsey. All 
these procedures require an abdominal or thoracic incision to wrap the 
stomach around the esophagus. The Belsey can require surgical removal of 
part of a rib. Each procedure takes about two hours to perform and they 
are attended by significant morbidity and mortality. In addition to being 
lengthy surgical procedures, spontaneous undoing of the plication is a 
major problem. Slippage has been the major cause of operative failures. 
The most commonly performed operation for correction of GER in infants and 
children has been the Nissen fundoplication. The Nissen is associated with 
postoperative complications of small bowel obstruction, paraesophageal 
hernia, wrap slippage, and the gas-bloat syndrome. Although another 
procedure, Thal fundoplication, appears to have fewer postoperative 
complications, it has not been as widely used due to a higher rate of 
recurrent GER. 
Successful techniques for the surgical treatment of gastroesophageal reflux 
appear to have several features in common: 1) lengthening of the 
indraabdominal portion of esophagus, 2) decreasing the angle of His, 3) 
construction of a valve mechanism at the GEJ, and 4) forming a complete or 
partial gastric wrap around the esophagus to augment extra-esophageal 
pressure (pressure originating outside the esophagus and acting on the 
esophagus). Recent technical advances in endoscopic surgery allow 
performance of a growing number of operations a minimally invasive manner. 
A schematic of a conventional flexible endoscope 1 is shown in FIG. 1B and 
a cross-sectional area of its insertion tube 21 is shown in FIG. 1C. 
Endoscope 1 typically includes a depressible button 3 to control air and 
water influx, a control 5 to manipulate suction, and a control head 7. A 
biopsy channel inlet 9 is typically located on control head 7, as is an 
eye piece or viewing aperture 11. Endoscope 1 communicates with an 
external air and/or suction device through end 13 and to an external light 
source through end 15. Knob 17 controls up and down deflection of a 
flexible tip 23 at the distal end of insertion tube 21 and knob 19 
controls left/right deflection of tip 23. A cross-sectional view of 
insertion tube 21 includes a lens 25, a light source 27, an air and water 
channel 29, and a biopsy and suction channel 31. 
In use, the operator inserts distal tip 23 down the esophagus of an 
anesthetized patient and into the patient's stomach. The operator can 
manipulate control knobs 17 and 19 to view an area of interest. Air and 
water can be injected into the patient's stomach to assist in viewing an 
area clearly. Air, water and other fluids can be removed by use of the 
suction. The availability of flexible fiberoptic endoscopes has 
facilitated the development of new surgical procedures and approaches. 
SUMMARY OF THE INVENTION 
The invention provides a method of fundoplication of a patient's stomach to 
his esophagus. Steps of the method include introducing an esophageal 
manipulator into the stomach lumen, maneuvering the manipulator within the 
lumen so as to create an intussusception of the esophagus into the 
stomach, introducing a tissue securing device to the lumen, and securing 
the intussuscepted esophagus to the stomach using the securing device and 
operating from within the lumen of the stomach. The securing device is 
preferably a stapler. The esophageal manipulator can be any of a variety 
of instruments, such as a hook, forceps, clamp, or other device adapted to 
grasp, control, engage or otherwise direct the esophageal or gastric 
tissue. 
"Intussusception" means that a part of the lumen of a hollow viscera or 
tubular structure is received by the lumen of an immediately adjoining 
part. "Lumen" generally refers to the interior of a hollow or potentially 
hollow structure such as a tubular structure. "Plication" means tucking or 
folding with the effect of shortening the plicated structure. 
"Fundoplication" means plication of the fundus of the stomach up around 
the lower or distal end of the esophagus which has been mobilized. 
A preferred method includes performing a percutaneous endoscopic 
gastrostomy (PEG). At least one of the esophageal manipulator and the 
tissue securing device is introduced to the stomach lumen through the 
gastrotomy incision. The securing device, such as a stapler, can have a 
longitudinally extending passageway through which the esophageal 
manipulator is passed for introduction into the lumen. Most preferably, 
endoscopic guidance assists with positioning at least one of the 
esophageal manipulator and the securing device. If the securing device is 
a stapler, it can emit staples in a variety of patterns. A T-shaped 
pattern is preferred. The staples are preferably positioned substantially 
perpendicular to a long axis of the esophagus. 
The invention provides a method of fundoplication of a patient's stomach to 
his esophagus comprising the steps of creating an incision in the 
patient's abdomen, approaching the stomach wall of the patient through the 
abdominal wall incision, incising the stomach wall, introducing an 
esophageal manipulator into the stomach lumen, engaging esophageal tissue 
by the manipulator, maneuvering the manipulator so as to create an 
intussusception of the esophagus into the stomach, introducing a tissue 
securing device, such as a stapler, to the lumen of the stomach, and 
securing the intussuscepted esophagus to the stomach. 
The method of the invention can further include the step of introducing a 
hollow visceral access port through the abdominal incision and the stomach 
wall incision into the stomach lumen. The access port car include a 
resorbable tubular sheath. 
The invention also includes a method of plication of a viscus other than 
the stomach and esophagus. An example is plication of the urethra to the 
urinary bladder. This method comprises introducing a tissue manipulator 
into a lumen of the viscus (such as the bladder), maneuvering the 
manipulator so as to create an intussusception of a proximate structure 
(such as the urethra) into the viscus, introducing a tissue securing 
device to the lumen of the viscus, and securing the intussuscepted viscus 
to the proximate structure. The securing device is preferably a stapler. 
The tissue manipulator can be any of a variety of instruments, such as a 
hook, forceps, clamp, or other device adapted to grasp, control, engage or 
otherwise direct tissue. 
The invention further includes a novel stapler adapted to staple tissue and 
for medical or surgical use with a medical component. The stapler has an 
elongated body having a first or proximal end and a second or distal end 
and a passageway extending therebetween. The passageway is adapted to 
house the medical component along the passageway. The stapler has a 
stapler head, positioned towards the first end, adapted to staple the 
tissue, and an actuator, positioned towards the second end and operatively 
coupled to the stapler head, adapted to actuate the stapler head so as to 
staple the tissue. 
The medical component received by the passageway can be any of a number of 
items useful in medical or surgical procedures. Examples include an 
esophageal manipulator, a tissue manipulator, a fluid including gases and 
liquids, reagents and medication. Most preferably, the passageway is 
adapted to receive a tissue engaging apparatus such as a grasping forceps, 
a biopsy forceps, a clamp, and a hook. 
The stapler head can have a hinged jaw adapted to contact tissue and expel 
staples therein, and the actuator preferably includes a hand grip. The 
stapler head can be adapted to simultaneously drive a plurality of the 
staples into the tissue in a T-shaped pattern. The individual staples are 
preferably longer than they are wide and are oriented with the length 
substantially perpendicular to an arm of the T-shaped pattern. Most 
preferably, the stapler is dimensioned and adapted for admittance into a 
channel within an endoscope. 
The stapler is particularly useful for fundoplication of the patient's 
stomach to the esophagus from the interior of the stomach. Preferably, the 
tissue engaging apparatus is used to grasp the tissue to be stapled and 
pulls the tissue into the region between the jaws of the stapler. The jaws 
are snapped shut onto the tissue to drive the staples into the grasped 
tissue. The jaws and tissue engaging apparatus then release the stapled 
tissue. The process can be repeated at different axial and rotary 
positions until the desired fundoplication is achieved. 
Other features and advantages of the invention will appear from the 
following description taken together with the accompanying drawings.

DESCRIPTION OF THE PREFERRED EMBODIMENT 
The invention includes two primary aspects: (1) the grabbing and retraction 
of esophageal tissue for creation of an intussusception at the GEJ 
accomplished from within the lumen of the stomach; and (2) a specialized 
staple gun which preferably accepts an axially moveable retraction device 
and has a particular pattern of staples. 
The invention was tested in pigs because the pig is an established model 
for gastroesophageal reflux investigation. The following protocol was 
approved by the University of California San Francisco Committee on Animal 
Research. Six York-Hampshire pigs were obtained from Pork Power (Tracy, 
Calif.). 
The pigs were fasted for two days except for unrestricted access to water 
until 12 hours prior to the experiment. They were immobilized with 
intramuscular ketamine (10 mg/kg). Inhalational anesthesia with 1-2% 
isoflurane and oxygen was given by endotracheal tube and mechanical 
ventilation (Narkovet Ill., North American Drager, Telford, Pa.). Subjects 
were placed on 5 centimeters (cm) water positive end expiratory pressure 
(PEEP) with tidal volume and rate adjusted to maintain normal oxygen 
saturation without overbreathing. Subjects were kept warm with a 
circulating water blanket. A volume of 500 milliliters (ml) of normal 
saline was infused intravascularly during the operation to maintain 
hydration. 
Subjects were placed on the operating table in the supine position. The 
table was tilted into 20 degrees reverse Trendelenburg. A flexible 
pediatric gastroscope 18 was placed into the lumen 32 of stomach 20 of 
subject 16 and angled anteriorly to transilluminate a site for a medial 
endoscopic port 22. See FIG. 3. A medial gastrotomy incision was placed in 
direct line with esophagus 24, about 2 cm to the right of the xyphoid and 
as far inferiorly as possible. A lateral gastrostomy incision was placed 
in the left anterior axillary line as far inferiorly as possible in 
preparation for receipt of a lateral port 26. 
The technique involved construction of a gastrostomy with nylon T-bar 
fixation devices 28 to provide positive control of the gastric or stomach 
wall 30. See FIG. 4. Stomach 20 was insufflated to 15 cm water pressure 
and a trocar 34 was inserted through the skin 35 and the abdominal wall 36 
into stomach 20. T-bar 28, in flexed or collapsed position, was passed 
through trocar 34 and allowed to open inside lumen 32 of stomach 20. The 
position was confirmed with gastroscope 18. After all 8 T-bars were 
inserted, they were tied together with suture 37 in pairs to provide 
fixation of stomach wall 30 to abdominal wall 36. This process was the 
same for both the medial and lateral incisions. 
Through each gastrostomy, a 12 millimeter (mm) endoscopic port, 22 and 26, 
was placed into stomach 20. A 10 mm rigid (0.degree. flexion) endoscope 
(Karl Storz, Germany), not shown, was passed through one of the ports to 
provide visualization of the gastroesophageal junction (GEJ) 38 and 
flexible scope 18 was withdrawn. 
After entering stomach 20, the GEJ 38 was identified. Fixation of GEJ 38 
for placement of staple lines was achieved by internal traction with 
endoscopic hooks 40. See FIG. 5. Each small hook 40 on a suture 42 was 
passed through endoscopic ports 22/26, alternating with the position of 
the rigid scope (not shown). Hooks 40 were placed into GEJ 38 under direct 
vision using endoscopic graspers 44. A pair of graspers 44 was used to 
position each hook 40 in the GEJ 38, and tension was applied through the 
endoscopic ports 22/26 to pull GEJ 38 into stomach 20. 
A GIA is a commercially available endoscopic accessory for cutting and 
stapling in one step. A modified 4.7 mm Endo GIA 30 (U.S. Surgical, 
Norwalk, Conn.) with the knife removed was introduced (46). See FIG. 6. In 
the open position, one jaw 50 of GIA stapler 46 was passed down esophagus 
24 while the other jaw was pushed against stomach 20, while tension was 
applied to traction hooks 40. See FIG. 7B. Arrow 56 shows the direction of 
applied tension. The effect was to pull GEJ 38 into the stapler jaws while 
creating an intussusception 48. Stapler 46 was fired to fix stomach 20 to 
esophagus 24 in the intussuscepted position. This process was repeated 3 
times, one row each in the right anterior, the right posterior, and the 
left lateral position to decrease the angle of His 52. Staples 54 
preferably form a T-pattern. 
During each experiment, GEJ 38 was tested for reflux. A nasogastric tube 
with a pH probe attached was placed into stomach 20, documenting the level 
of GEJ 38 as the point of drop in pH and return of gastric contents. A 
volume of 10 ml/kg of 0.1 normal hydrochloric acid (N HCL) was instilled 
into stomach 20. The pH probe and the nasogastric tube were pulled back 5 
cm above GEJ 38. A series of tests of gastroesophageal reflux were done; 5 
minutes with the animal supine, 5 minutes with a 10 kg weight on its 
abdomen, and 5 minutes in Trendelenburg position of 30 degrees. 
Continuously recorded esophageal pH documented any gastric acid reflux 
into the esophagus. The animals were sacrificed after these tests. 
The endoscopic antireflux procedure was easily performed. Creation of the 
two gastrostomies was the most time consuming part of the procedure. The 
gastrostomies were useful for placement of ports 22/26 and easily 
withstood the multiple insertions of instruments required for the 
procedure, providing secure, leak free gastric access. 
The use of small endoscopic hooks 40 placed endoscopically allowed traction 
on GEJ 38 which then intussuscepted 48 into stomach 20. Once this step was 
performed, fixation of esophagus 24 in the intussuscepted intragastric 
position was done. The size of hooks 40 was important: if they were too 
large they tended to perforate esophagus 24, and if too small they grabbed 
only esophageal mucosa which easily tore. Preferably, a diameter of hook 
40 is about 5 mm. 
Placement of three rows of staples with endoscopic stapler 46 was easily 
performed and fixed esophagus 24 in the intragastric position. There was 
no gastric or esophageal leakage despite the through-and-through placement 
of staples 54. 
When the completed antireflux procedure was tested for competence, it 
prevented acid reflux into the esophagus after acid instillation into the 
stomach. The endoscopic transgastric antireflux procedure prevented 
gastric acid reflux during performance of maneuvers designed to elicit GER 
such as abdominal compression and Trendelenburg position. Autopsy revealed 
formation of a flap valve at GEJ 38 with intussusception 48 of esophagus 
24 into stomach 20. The flap valve collapses inwardly due to intragastric 
pressure. 
The invention is preferably practiced clinically as follows: An endoscope 
58 is placed down esophagus 14 into stomach lumen 10 while the patient is 
under general anesthesia. Stomach lumen 10 is inflated with air. By 
correctly positioning endoscope 58, the stomach wall 78 can be directed 
towards the abdominal wall (not shown). The surgeon makes an incision in 
the skin to enter stomach lumen 10 through the abdominal wall. 
Alternatively, a needle is inserted into stomach 10 through the abdominal 
wall and a wire is placed along the needle's path. A dilator is placed 
over the wire to enlarge the opening which will become the gastrostomy. 
This procedure with modifications is well known and is called a 
Percutaneous Endoscopic Gastrotomy or PEG. 
At least one hook device such as a tethered hook 40 (FIG. 7A) or a device 
to grab tissue, such as a device with a moveable jaws 66 (FIG. 8A), is 
introduced through the port. Tethered hook 40 preferably has a diameter of 
about 5 mm. Hook 40 is attached to a line such a suture material 42. Thus, 
tension (shown by arrow 56) on suture 42 is transmitted to hook 40. See 
FIG. 7B. With endoscopic guidance, device 40 or 66 grabs tissue at the 
GEJ. See FIG. 8A. This gastroesophageal tissue is pulled downward into 
stomach lumen 10, creating an intussusception of esophagus 14 into stomach 
lumen 10. The intussuscepted esophagus 14 is stapled to the wall of 
gastric fundus 78 to create a fundoplication. 
A port, not shown, is placed to gain access from the skin surface to the 
stomach lumen. Such ports are known and used for PEG procedures. See, for 
example, U.S. Pat. Nos. 4,863,438; 4,944,732; and 5,007,900 which are 
incorporated by reference herein. The port could include a resorbable 
sheath so that surgical removal of the port is unnecessary. 
Alternatively, using gastroscope 58 for visualization, an instrument is 
passed through the port and sutures (not shown) are applied through the 
GEJ. These sutures are used for maintaining tension on the GEJ and pulling 
the GEJ down into the abdomen. When this is done, the esophagus is 
intussuscepted into the gastric fundus. Using gastroscope 58 for 
visualization, the tension sutures are pulled out through the instrument 
port. Tension is maintained on these sutures as instruments are passed in. 
The invention uses a stapling device 68 to fix fundal wall 78 alongside the 
esophagus 14 to form an esophageal wrap from within stomach lumen 10. See 
FIG. 8A. See FIG. 2 generally for anatomic references to the stomach. FIG. 
8B shows staples 54 placed to secure intussusception 48 of esophagus 14 to 
fundus 78. The angle of His 52 becomes more acute after the stapling 
procedure. An advantage is that the method can be done with minimum 
invasion by use of endoscopic techniques. It also provides an esophageal 
wrap that can be done in a very short period of time, preferably about 15 
minutes. This should lead to reduced morbidity and mortality. In addition, 
because of the vertical staples, the wrap is less likely to slip. 
Stapler 68 is preferably a specialized modification of existing staple 
guns, such as those made by Ethicon Autosuture GIA of Cincinnati, Ohio, or 
U.S. Surgical Endo GIA of Norwalk, Conn. See FIGS. 8A and 8C for details 
of the stapling end of stapler 68. See FIG. 9 for a schematic of the 
entire stapler 68, including its internal grasper 72. Stapler 68 includes 
a passageway 70 through which hook 40 or jaw-like grasper 72 is introduce 
so that a single step accomplishes grabbing of esophageal tissue and 
stapling. The staples should be oriented horizontally, although the 
procedure works with vertically oriented staples. "Horizontal" in this 
context means perpendicular to a long axis of the esophagus. That is, the 
axially extending body of the staple is horizontal in contrast to the 
radially extending legs of the staple. Vertically oriented staples are 
depicted because the stapler used was a modified prior art device. 
Preferably the staples form a T configuration and the tip 74 of the 
plicated fundus and esophagus is left unstapled and floppy to assist in 
functioning as a valve. See FIG. 10 for a detail of a stapler jaw designed 
to emit staples in a T-shaped pattern. 
Staplers can be designed specifically for the invention. A stapling device 
which performs the dual tasks of traction on the GEJ and placement of a T 
shaped staple line above the GEJ is preferred. This device incorporates 
either a central grasping device or aligned grasping devices on either 
side of the stapler. The GEJ is grasped, traction applied to pull the GEJ 
into the jaws of the Stapler to the appropriate depth, and the stapler is 
fired. 
A schematic of the entire stapler device 68 is shown in FIG. 9. At an 
operating end are movable jaws 66. These are connected by means of 
elongate body 80 to a handle 82. Elongate body 80 includes a passageway 
which can house grasper 72. Grasper 72 is independently movable within 
body 80 by means of movable handle 84 as indicated by arrow 98. Also 
included is a button 86 on handle 82 which tightens stapler jaws 66. 
Button 88 on handle 82 fires the staples from the operating end of jaws 
66. 
Alternatively, a tissue approximator (TA) stapler is admitted. One jaw is 
placed inside the esophagus, the other along the gastric wall to be placed 
next to a tension suture. The TA is pushed up thus approximating the 
gastric wall to the esophagus and the TA is fired. The preferred length of 
the endoscopic TA stapler head is 3 cm. Modifications of the stapling 
device may be desirable, including placing the traction sutures through a 
small opening in the stapler and allowing the stapler to slide up the 
suture much as a dilator goes along a wire. This would insure very 
accurate placement on the GEJ where the suture is placed. 
Instead of conventional surgical staples, tacks could be fired by the 
stapler. See FIGS. 8C and 8D. Movable jaws 66 can be adapted to hold a 
tack 90. Preferably, tack 90 includes a head 92, two legs 94, and is 
secured by a foot 96 after firing of stapler 68. FIG. 8D shows a tack 90 
which has been secured in place to hold intussusception 48 of esophagus 14 
to fundal wall 78. Angle of His 52 is more acute than preoperatively. 
In any of the embodiments of the invention, lengthening of the 
intraabdominal esophagus can be achieved without dividing the 
phrenoesophagal ligament and mobilizing the GEJ as is done in open 
procedures. This is accomplished not by pulling the esophagus down into 
the abdomen as in open fundoplication procedures but rather by pushing the 
diaphragm and stomach up around the esophagus and fixing them in place. 
The net effect is equivalent: the esophagus is surrounded by 
intraabdominal pressure instead of negative intrathoracic pressure, but 
the integrity of the GEJ is not disrupted. 
The formation of a gastric wrap around the esophagus is an important 
element in preventing esophagal reflux because intragastric pressure is 
applied to the outside of the esophagus. Thus, increased intragastric 
pressure should not overcome the lower esophageal sphincter pressure. This 
technique forms a gastric fundoplication similar to the Belsey Mark IV. 
The angle of His 52 is decreased by placing the staple line along greater 
curvature 100. See FIG. 2. The effect is to fold stomach 12 up alongside 
esophagus 14. This creates a type of flap valve that tends to close the 
lower esophageal sphincter in the direction of arrow 76. See FIG. 8A. The 
flap valve is preferably a 3 cm length of esophagus 14 which is 
intussuscepted into stomach 12. Following the principles of Kock valve 
creation, a technique known and used to surgically correct uterine 
prolapse, this forms an antireflux valve. 
In addition to satisfying the anatomic requirements of an antireflux 
procedure, the inventive approach has other advantages. The gastric 
fundoplication is performed without entering the peritoneal cavity. 
Absence of intraperitoneal invasion decreases or eliminates the risk of 
adhesion formation and subsequent small bowel obstruction, a particularly 
dangerous complication of adhesions. A second advantage is most apparent 
in the high risk group of neurologically damaged children. The minimally 
invasive nature of the inventive technique decreases surgical morbidity in 
this compromised population. Also performance of an antireflux procedure 
at the time of gastrostomy in the absence of documented reflux would be 
uncontroversial with the use of a minimally invasive procedure with low 
morbidity. 
Although the invention has been described in detail, the artisan will 
appreciate that there are other modifications which would not depart from 
the invention. For example, instead of placing the stapler through the 
operating port in the stomach, a reversed stapler with the jaws facing 
backwards could be passed down the esophagus using visualization through 
the esophagus or the gastrostomy port. Retraction sutures would maintain 
traction as the stapler is pulled back up the esophagus with one jaw 
projecting into the stomach. This would provide the same maneuver as the 
TA description above. Also, a securing device other than a stapler could 
be used. For example, instruments competent to assist in placing sutures 
could be employed instead of a stapler. Thus, the invention is not limited 
by the preceding description and the illustrations, but rather by the 
appended claims.