Surgical loop delivery device and method

A device for delivering a loop of suture material for use in endoscopic ligation is described. The device has a pair of coaxial slidable cylindrical tubes. The outer tube contains a hook for snaring the free end of the suture material; the inner tube contains a groove for retaining the suture loop circumferentially about the bore of the inner tube and also a hole beyond which the slip knot cannot move proximally. When the inner tube is pushed in a distal direction relative to the outer tube, the loop is pulled off the groove and is tightened. In use a grasping tool is inserted through the bore of the inner tube and is used to grasp a piece of tissue to be ligated. The device is then deployed, ligating the tissue piece.

BACKGROUND OF THE INVENTION 
1. Field of the Invention 
The present invention relates to surgical devices and methods and, more 
particularly, to devices and methods for delivering a loop of suture 
material to a tissue segment for the purpose of ligation. 
2. Description of Related Art 
Modern surgical techniques often entail the use of endosurgery, wherein 
large incisions are avoided, and, instead, elongated instruments are 
inserted into and manipulated through trocars. Typically the surgical 
site, such as the peritoneum, is viewed remotely, and the surgeon works 
while watching a monitor. 
Endoscopic applications of preknotted suture loops include the ligation of 
protruding pieces of tissue such as polyps or ends of blood vessels. 
Several devices are known in the art that deliver such suture loops to a 
site generally remote from the surgeon's hand and are remotely 
manipulable. 
The tonsillotome of Longino (U.S. Pat. No. 1,468,599) contains a shank 
having a lumen wherein a suture loop resides and from which the loop is 
manipulable around a piece of tissue. Previously disclosed devices include 
those of Neivert (U.S. Pat. No. 1,833,687), who discloses a surgical snare 
comprising a fixed and a movable member capable of relative movement for 
tightening the snare loop that has been housed in the bore of the movable 
member. 
The ligating loop device of Buelna (U.S. Pat. No. 5,242,459) has a shaft 
with a suture loop at its distal end, the loop having a slip knot. In 
addition, the device has a cutting element for severing the loop once it 
has been tightened. As with the device of Neivert, relative movement 
between two cylindrical members causes a tightening of the knot. 
Noda et al. (U.S. Pat. No. 5,320,629) also contains relatively slidable 
members, one of which carries a suture with a slip knot at the end. 
The endoscopic loop applying instrument of Kinet et al. (U.S. Pat. No. 
5,405,351) both delivers the loop and cuts the free end of suture 
material. 
The ligating instrument of Yoon (U.S. Pat. No. 5,486,186) also delivers a 
loop of suture material, the material extending through the lumen of an 
elongated device for being operated upon to tighten the loop around a 
piece of tissue. A cutter is also disclosed that is positioned within the 
lumen and is externally operable. 
A problem shared by the above devices, however, is the difficulty in 
positioning and manipulating the suture loop, which must be accomplished 
with the use of a second portal and grasping instrument. In addition, the 
loop itself can collapse once inserted and thus lose its "loop" character, 
also making it difficult to snare a piece of tissue. 
SUMMARY OF THE INVENTION 
It is therefore an object of the present invention to provide a device and 
method that delivers to a surgical site a tightenable loop of suture 
material that is supported in an open position until the target tissue is 
snared. 
It is an additional object to provide such a device and method that permits 
the passage of a grasping instrument through a common access portal with 
the device. 
It is another object to provide such a device and method that permits the 
positioning of the grasping instrument through the loop prior to 
tightening. 
It is a further object to provide such a device and method that includes 
means for cutting the free end of suture material from the tightened loop. 
It is yet another object to provide such a device that can employ a 
cartridge preloaded with a loop of suture material and is therefore 
reusable with the introduction of a replacement cartridge. 
It is yet an additional object to provide such a device that is operable 
with one hand. 
These and other objects are achieved by the present invention, a device and 
method for delivering a loop of suture material for endoscopic ligation. 
The suture material, which may be preloaded onto the device prior to use, 
has a free end away from the loop and a slip knot that permits the loop to 
be tightened when the free end is pulled. 
The suture loop delivery device comprises an outer tube that has a length 
commensurate with its intended use; that is, it must be sufficiently long 
to extend into the surgical site, typically through a trocar. The outer 
tube also has a longitudinal bore that extends from the tube's distal end 
to its proximal end. 
The device further comprises an impelling member that has a distal portion 
dimensioned to freely slide within the outer tube bore, permitting 
relative sliding motion between a loading position and a deployed 
position, which is distal of the loading position. The impelling member 
also has a longitudinal bore extending from the distal end to the proximal 
end. 
The suture material is preloaded onto a loop support member, which has a 
proximal portion that is dimensioned to reside within the outer tube bore. 
In a first embodiment, the proximal portion in turn has a proximal section 
that is dimensioned to reside within the impelling member bore. The loop 
support member also has a longitudinal bore extending from the distal to 
the proximal end. 
The suture material is loaded onto the loop support member in such a way 
that the loop and the slip knot are retained thereon circumferentially so 
as to encircle the loop support member bore. The slip knot is prevented 
from moving in a proximal direction, but the loop is releasable from its 
supported position on the loop support member when tension is applied to 
the free end, which is affixed to the loop support member. 
In the first embodiment, means are also provided for making accessible to 
the loop support member exterior an exposed length of suture material 
between the free end and the slip knot. This suture material exposed 
length is positioned so as to be snarable by an element positioned within 
the impelling member's bore, after the loop support member has been mated 
with the outer tube generally adjacent the outer tube's distal end. 
During a loading operation the impelling member's distal portion is 
positioned within the outer tube. The loop support member, having a loop 
of suture material retained thereon, is mated to the outer tube, and its 
proximal portion is positioned within the outer tube bore, with its 
proximal end generally adjacent the impelling member's distal end. The 
exposed length of suture material is aligned with the snaring element. 
The device is deployed in the first embodiment by pushing the impelling 
member in a distal direction relative to the outer tube, which causes the 
snaring element to snare the exposed length of suture material. Continued 
motion in the distal direction pulls the suture material, which causes the 
loop to tighten. 
The bores of the outer tube, impelling member, and loop support member are 
generally coaxial and are dimensioned to permit the passage of a grasping 
tool through the assembled device. This permits the grasping tool to be 
inserted therethrough, which then may be used to grasp a piece of tissue. 
The device is then deployed to ligate the grasped piece of tissue. 
In a particular embodiment means are also provided for cutting the suture 
material between the free end and the knot. The cutter has a cutting edge 
and is movable between a first position in spaced relation to the suture 
material and a second exposed position in cutting relation to the suture 
material between the free end and the knot. In use the cutting means is 
employed following a deploying of the device to sever the suture material 
loop from the loop support member. 
In a second embodiment of the loop delivery device, the loop support member 
has a proximal portion that is dimensioned to reside at least partially 
within the outer tube bore. Means are provided for mating the loop support 
member with the impelling member at a position generally adjacent the 
impelling member's distal end. 
In this embodiment, the snaring means is located within the outer tube bore 
in such a position to be able to snare the exposed length of suture 
material when in the deployed position. The device is then deployed by 
placing the impelling member within the outer tube. Then the loop support 
member, having a loop of suture material retained thereon, is mated to the 
impelling member and is positioned within the outer tube bore. In this 
position, the exterior section of suture material is snared. The impelling 
member is deployed by pushing the impelling member in a distal direction 
relative to the outer tube, pulling the snared exterior section of suture 
material against the slip knot, which serves to tighten the loop. 
The features that characterize the invention, both as to organization and 
method of operation, together with further objects and advantages thereof, 
will be better understood from the following description used in 
conjunction with the accompanying drawing. It is to be expressly 
understood that the drawing is for the purpose of illustration and 
description and is not intended as a definition of the limits of the 
invention. These and other objects attained, and advantages offered, by 
the present invention will become more fully apparent as the description 
that now follows is read in conjunction with the accompanying drawing.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
A description of the preferred embodiments of the present invention will 
now be presented with reference to FIGS. 1-30. 
Embodiment One 
A first preferred embodiment 10 of the device to be described herein, shown 
assembled in FIGS. 1, 5, and 6, is for delivering a loop of suture 
material for endoscopic ligation. The suture material 50, which 
preparatory to the device's use is loaded onto the device 10, has a free 
proximal end 502 and a slip knot 504 for forming the loop 506 at the 
distal end and for permitting the loop 506 to be tightened (see FIG. 5). 
The device 10 comprises an outer tube 20. Outer tube 20 has a length 206 
and a longitudinal bore 208 that extends from the distal end 202 to the 
proximal end 204. 
Extending distalward from the outer tube distal end 202 is a mating tab 
216, having an inwardly facing tab protrusion 217 (see FIG. 15). Tab 216 
is somewhat flexible, but is biased to a position wherein the outer 
surfaces of tab 216 and the outer tube distal end 202 are generally 
axially collinear. The purpose of the tab 216 will be discussed in the 
following. 
A first grasping member 210 is affixed adjacent the outer tube's proximal 
end 204, which in the embodiment shown comprises a handle having a 
generally circular portion 212 and a downwardly curving portion 214 
extending laterally therefrom. The circular portion 212 is dimensioned to 
permit the insertion of a finger, generally a middle finger or forefinger, 
of the surgeon; the curving portion 214 is dimensioned to permit the 
bracing of a finger, generally a third or middle finger, of the surgeon. 
The circular portion 212 is affixed to the outer tube 20 by means of a 
first generally toroidal member 222 that encircles the outer tube 20 and 
is affixed via first set screw 221 to the exterior thereof. Generally 
laterally opposite the circular portion 212, and partially protruding 
above a proximal face 223 of the first toroidal member 222, is a ball and 
spring plunger mechanism 224, the spring portion and a distal section of 
the ball of which are housed within the first toroidal member 222. 
Laterally adjacent and outside the plunger mechanism 224 is a proximally 
extending post 225. A longitudinal bore 226 extends completely through the 
post 225 and the first toroidal member 222. The bore 226 is noncentrally 
located relative to the post 225. An "L"-shaped groove (not shown) runs 
generally parallel to the bore 226 from the post's proximal end 228 to 
adjacent its distal end 229, makes a generally right-angle turn, and runs 
circumferentially adjacent the toroidal member 222 around the post 225 
approximately 180 degrees. 
A generally cylindrical locking member 24 has a bore 242, the distal 
section 243 of which is dimensioned to admit and slidably engage the post 
225. Generally adjacent the locking member's distal end 244 and within the 
bore 242 is affixed an alignment pin (not shown), which is dimensioned to 
ride within the post groove. Disposed about the locking member's distal 
surface 246, generally at 90 and 180 degrees therefrom, are two radial 
grooves. The interaction between these grooves and the ball and spring 
plunger 224 provides two stable positions assumable by the locking member 
24 relative to the post 225. 
The proximal section 250 of the locking member bore 242 is dimensioned and 
positioned to permit locking, limiting, and assembling of the impelling 
member 30, which will be discussed in the following. From the proximal 
surface 251 this bore section 250 appears as a trilobed opening (see FIG. 
12), with the lobes 252,253,254 of three different sizes, increasing in 
that order, used for, respectively, locking and limiting the impelling 
member 30 and assembling the device 10. Bore section 250 is narrower than 
the bore's distal section 243. 
Device 10 further comprises an impelling member 30 (see FIGS. 1, 5, and 6) 
that has a distal portion 306 dimensioned to freely slide within the outer 
tube bore 208 and a longitudinal bore 308 that extends from the distal end 
302 to the proximal end 304. Bore 308 is dimensioned to permit the passage 
of a grasping tool 60 therethrough, the function of which will be 
described in the following. 
The impelling member 30 has a proximal section 301 having a first diameter. 
The distal portion 306 has a second diameter larger than the first 
diameter. 
In general the impelling member distal portion 306 is slidable within and 
relative to the outer tube bore 208 between a first position (FIGS. 1 and 
16) wherein the impelling member distal end 302 resides a first distance 
from the outer tube distal end 202 and a more distal position (FIGS. 19 
and 20) wherein the impelling member distal end 302 resides a second 
distance to the outer tube distal end 202, the second distance less than 
the first distance. This will be shown in the following to achieve a 
tightening of the slip knot 504 to effect loop 506 tightening. 
Toward the impelling member's distal end 302 is positioned an outer 
circumferential groove 340 dimensioned to seat an O ring 34 therein, for 
sealing the space between the outer tube 20 and the impelling member 30. 
A second grasping member 316 is affixed adjacent the impelling member's 
proximal end 304, which in the embodiment shown in FIG. 1 comprises a 
handle having a generally circular portion 318 dimensioned to permit the 
insertion of a finger, generally a thumb, of the surgeon. When used in 
concert, the first 210 and the second 316 grasping members permit the 
surgeon to push the impelling member 30 distalward relative to the outer 
tube 20 in order to deploy the device 10, the details of which will be 
discussed in the following. 
The circular portion 318 is rotatably affixed to the impelling member 30 by 
means of a second generally toroidal member 328 that encircles the 
impelling member 30 and is rotatable around the exterior thereof. The 
second toroidal member's bore 341 is dimensioned to closely engage the 
impelling member's proximal section 303 but to be smaller than the distal 
portion 306, which prevents it from moving distally. 
Generally laterally opposite the circular portion 318, and protruding above 
a proximal face 329 of the second toroidal member 328, is a second ball 
and spring plunger mechanism 327, the spring portion and a distal section 
of the ball of which are housed within the second toroidal member 328. The 
purpose of this mechanism 327 will be discussed in the following. 
Radially outward of the second ball and spring plunger mechanism 327 and 
protruding downward from the distal face 332 of the second toroidal member 
328, generally parallel to the impelling member's longitudinal axis, is 
alignment and restraining rod 33, which has a proximal portion 331 and a 
larger-diameter distal portion 330. Rod 33 and locking member 24 operate 
in concert to permit the assembly, locking, and deploying of the device 10 
as follows: 
For assembly, locking member 24 is positioned so that, when the impelling 
member distal portion 306 is inserted into the outer tube bore 208, rod 33 
is insertable into largest lobe 254, which is dimensonioned to permit the 
rod's distal portion 330 to pass therethrough, the second toroidal 
member's distal face 332 abutting the locking member's proximal surface 
251. 
Limiting the travel of the outer tube 20 and impelling member 30 relative 
to each other is achieved by turning the locking member 24 clockwise (as 
viewed from above) 90 degrees, so that the first radial groove and the 
first plunger mechanism 224 are opposed. This causes the rod's proximal 
portion 331 to be moved into the medium lobe 253, which is large enough to 
permit the rod's proximal portion 331 to travel freely therethrough, but 
which is too small to permit the rod's distal portion 330 to pass, thereby 
restraining the rod's distal portion 330 within the locking member bore 
242. 
Locking the relative movement of the outer tube 20 and the impelling member 
30 is effected by turning the locking member 24 clockwise another 90 
degrees, so that the second radial groove and the first plunger mechanism 
224 are opposed. This causes the rod's proximal portion 331 to be moved 
into the smallest lobe 252, which is small enough to block any movement of 
the rod 33. 
Within the impelling member's bore 308, in spaced relation to the distal 
end 302, is protrudes pin 342 for snaring the exposed length of suture 
material 508 (see FIG. 15). Adjacent the pin 342 in a clockwise direction 
is a generally longitudinal alignment slot 310 for mating with loop 
support member 40, which will be described in the following. 
Atop the impelling member's proximal end 304 is placed a generally 
cylindrical actuator member 36 (see FIG. 11), which is affixed via second 
set screw 361 (FIG. 5) so that actuator member bore 362 surrounds the 
proximal section 303. Actuator member 36 comprises a serrated annular 
grasping portion 364 that protrudes radially outward to facilitate 
rotation. It can be seen that turning grasping portion 364 effects a 
rotation of the impelling member 30 relative to the second toroidal member 
328. 
Disposed about the actuator member's distal surface 366, generally at 45 
and 90 degrees therefrom, are three radial grooves (not shown). The 
interaction between these grooves and the second ball and spring plunger 
327 provides three stable positions (loading, deploying, and cutting) 
assumable by the actuator member 36 relative to the second toroidal member 
328. 
Atop the actuator member 36 is a protective cap 324, which is generally 
formed of a plastic material and has a deformable slit 326 dimensioned to 
be expandable for admitting a surgical implement such as a grasping tool 
60 thereinto. Cap 324 serves to shield the proximal end 304 of the 
impelling member 30 and to prevent gas leakage from the surgical site. 
The device 10 further comprises a generally cylindrical loop support member 
40 that has a proximal portion 406 dimensioned to reside at least 
partially within the impeller member bore 308 (see FIGS. 6-10). The loop 
support member 40 also has a longitudinal bore 408 extending from the 
distal end 402 to the proximal end 404 that communicates with the 
impelling member bore 308 when those two elements are mated together. In a 
preferred embodiment the loop support member 40 has an outwardly 
projecting protrusion 410 adjacent the proximal end 404 that is 
dimensioned to slide within the slot 310 in the impelling member's distal 
portion 306. Mating is thus accomplished by lining up the protrusion 410 
with the slot's 310 distal end 312, pushing the two elements together 
until the proximal end 313 of the slot 310 is reached. In this position, 
approximately half of the loop support member 40 resides within the 
impelling member bore 308 and is rotationally coupled thereto by the 
protrusion/slot 410/310 mating. 
The loop support member proximal portion 406 further has a longitudinal 
slot 412 that extends from the proximal end 404 and has a length 
approximately the same as the impelling member slot 310. This slot 412, 
which communicates with bore 408, is positioned radially adjacent to and 
counterclockwise of protrusion 410, and is further positioned so that pin 
342 rides therein when protrusion 410 is inserted into the impelling 
member bore 308 and rides along slot 310. 
Radially adjacent to and counterclockwise of slot 412 is external groove 
411, which extends from the proximal end 404 to the distal end 407 of 
proximal portion 406. Groove 411 does not communicate with bore 408. 
Radially adjacent and counterclockwise of groove 411, and distal of the 
distal end 409 of slot 412 is first alignment pin 463, which protrudes 
radially outward. Second alignment pin 464, which also protrudes radially 
outward, is positioned approximately 180 degrees from the first alignment 
pin 463 and is clockwise of slot 412. These elements will be discussed in 
the following with regard to the cutting feature. 
Affixed to the distalmost section of the proximal portion 406 is distal 
portion 450, a generally cylindrical member having a larger external 
diameter and a larger bore diameter than those of the proximal portion 
406. The distal portion's proximal end 452 encompasses the proximal 
portion's distal end 407. At the distal portion's distal end 454 the 
distal portion 450 is widened further, creating a shoulder 456. The larger 
bore diameter at the distal end 454 is sufficient to permit the jaws of a 
grasping tool 60 to be opened at least partially therewithin. 
A small slot 458 that communicates with bore 408 extends from the distal 
portion's proximal end 452 and is aligned with groove 411. Slot 458 is 
longer than the overlap between the proximal portion 406 and the distal 
portion 450, which leaves a window 451 through to the bore 408 that is 
sufficiently large to permit suture material 50 to pass therethrough. 
Approximately 90 degrees radially from the slot 458 and 180 degrees from 
each other are two generally rectangular cutouts 465,466 in the distal 
portion's distal end 454 having a longitudinal extent less than the 
overlap between the proximal portion 406 and the distal portion 450. These 
elements will be discussed in the following with regard to the cutting 
feature. 
Adjacent the distal portion's distal end 454 is a recessed circumferential 
groove 460 (FIG. 9) dimensioned to permit suture material 50 to fit 
thereinto and be held there when under no tension. Two radial holes 
461,462 extend from the exterior of the distal portion 450 through to the 
bore 408. First hole 461 is distal of and generally axially aligned with 
slot 458. Second hole 462 is further distal yet, is generally axially 
aligned with slot 458, and communicates with circumferential groove 460, 
which at this point has an enlarged distal portion 467 that is 
sufficiently large to retain the suture material's slip knot 504 therein. 
Proximal of its distal portion 467, however, second hole 462 is too small 
to permit the slip knot 504 to pass therethrough. This dimensioning 
thereby serves to restrain the slip knot 504 from proceeding in a proximal 
direction beyond the enlarged distal portion 467. 
The suture material 50 is thus loaded onto and supported on the loop 
support member 40 as follows (see FIGS. 6A, 8 and 9): The suture loop 506 
is positioned within the inner groove 460, with the slip knot 504 
positioned within the second hole's enlarged distal portion 467 adjacent 
the second hole 462. Thus the loop 506 when loaded encircles the loop 
support member bore 408. 
The suture material's free end 502 is threaded from within the bore 408 to 
the exterior surface via second hole 462 and then back into the bore 408 
via first hole 461. The free end 502 is next threaded from the bore 408 to 
the exterior surface via window 451 and is positioned within slot 458 and 
groove 411. 
At the proximal portion's proximal end 404 the suture material 50 crosses 
the slot 412 in a clockwise direction and is affixed to the proximal end 
404, leaving an exposed length 508 of suture material 50 across the slot 
412. In the embodiment shown, the suture material 50 is affixed with 
protrusion 410, shown here as a screw; however, it may be appreciated that 
the affixing may be accomplished by any means known in the art, such as 
heat staking. 
When tension is applied to the free end 502 by snaring and pulling on the 
exposed length 508, as shown in FIGS. 19-21, tension is transmitted to the 
loop 506, and the slip knot's 504 being retained at the second hole 462 
causes the loop 506 to tighten. The inner groove 460 is shaped with no or 
minimal inner shoulder, thereby permitting the loop 506 and slip knot 504 
to slide off the groove 460 during tightening. 
The snaring and pulling of the exposed length 508 of suture material 50 for 
tightening are accomplished as follows: The loop support member 40 is 
mated to the impelling member 30 as described previously, the pin 342 
positioned to snare the suture material exposed length 508, which sets the 
device 10 for deploying. The device 10 is then deployed by pushing the 
first 210 and the second 318 grasping members toward each other until the 
first 222 and the second 328 toroidal members sandwich the locking member 
24 between them. This pushes the impelling member 30 in a distal direction 
relative to the outer tube 20 and to the loop support member 40, and the 
pin 342 pulls the snared exposed length 508 of suture material 50 in a 
distal direction, thereby tightening the loop 506. 
In a preferred embodiment of the invention, means are provided for cutting 
the suture material 50 between the slip knot 504 and the free end 502. In 
general, the cutter has a cutting edge that is movable between a first 
position in spaced relation to the suture material 50 and a second 
position in cutting relation to the suture material 50 between the slip 
knot 504 and the free end 502. 
Specifically, this is accomplished in a particular embodiment, illustrated 
in FIGS. 7, 8, and 23-25, with a generally cylindrical cutting assembly 
48. Cutting assembly 48 has a proximal portion 481 having a proximal end 
482, a wider distal portion 483 having a sharpened distal end 484, and a 
longitudinal bore 486. A shoulder 493 separates the distal portion 483 
from the proximal portion 481 and encircles the cutting assembly 48. A 
cutout 480 in the distal portion 481 extends distalward from the shoulder 
493, the depth of which matches the width of the shoulder 493. Within the 
cutout 480 is an inwardly extending dimple 492. The cutout 480 and dimple 
492 are dimensioned to be matable with the tab 216 and protrusion 217, 
respectively. 
The cutting assembly's bore 486 is sufficiently large to permit the cutting 
assembly 48 to surround the loop support member's proximal portion 406 and 
distal portion proximal end 452, but too small to pass beyond the shoulder 
456 leading to the loop support member's distal portion's distal end 454. 
Bore 486 is also too small to permit the cutting assembly 48 to pass 
beyond the protrusion 410. Therefore, protrusion 410 and shoulder 456 
serve to retain cutting assembly 48 in surrounding relation to the loop 
support member 40. These parts are thus assembled by sliding the cutting 
assembly 48 over the loop support member's proximal end 404 prior to 
affixing protrusion 410 thereto. 
The cutting assembly's proximal portion 481 is sufficiently small to permit 
entry into the outer tube's bore 208; the distal portion 483 is too large 
to fit thereinto. Mating the cartridge, which comprises the loop support 
member 40 and the cutting assembly 48, with the outer tube 20 is achieved 
by inserting the loop support member's proximal end 452 and cutting 
assembly's proximal portion 481 into the outer tube bore 208, with the tab 
216 aligned with cutout 480. When the tab 216 is pushed sufficiently far 
into cutout 480 that protrusion 217 snaps into dimple 492, a kinetic 
coupling between the cutting assembly 48 and the outer tube 20 is achieved 
(see FIG. 15). 
The cutting assembly's proximal end 482 is contoured (see FIG. 8). Two 
generally flat portions 489 are generally 180 degrees apart. Two 
proximally extending ramps 490, meeting the flat portions 489 radially, 
are also generally 180 degrees apart. The ramps 490 each slope upward (in 
a proximal direction) proceeding clockwise (viewing in a distal direction) 
and end in a downward (distally extending) shoulder that meets the 
opposite flat portion 489. 
When in the assembled position, with the cutting assembly 48 in surrounding 
relation to the proximal end 452 of the loop support member's distal 
portion 450, alignment pins 463,464 further restrict the longitudinal 
movement of the cutting assembly 48, as the pins' 463,464 radial extent is 
larger than the diameter of bore 486 (see FIG. 7). Two interior 
longitudinal grooves 485,486 extend from the cutting assembly's proximal 
portion's proximal end 482 to the distal portion's distal end 484 and are 
radially positioned along the flat portions 490 of the proximal end 482. 
Grooves 485,486 are spaced approximately 180 degrees from each other and 
are dimensioned to permit alignment pins 463,464 to travel therein. Bore 
486 and grooves 485,486 are therefore dimensioned and positioned to permit 
a proximal movement of the cutting assembly 48 relative to the loop 
support member 40 when the pins 463,464 are positioned within the grooves 
485,486. 
Pins 463,464 are further positioned so that, when the pins 463,464 are 
proximal of the cutting assembly's proximal end 482, and when the cutting 
assembly 48 is rotated relative to the loop support member 40 in a 
counterclockwise direction, pins 463,464 ride along the cutting assembly's 
proximal end 482. Thus, if pins 463,464 are proximal of grooves 485,486, a 
counterclockwise rotation will cause the cutting assembly 48 to move in a 
distal direction as the pins 463,464 engage the ramps 490. The cutting 
assembly 48 and loop support member 40 are further dimensioned so that, 
when the pins 463,464 approach the top of the ramps 490, the cutting 
assembly's sharp distal end 484 abuts the loop support member's shoulder 
456. In this position, since the suture material 50 when loaded passes 
over the shoulder 456 when proceeding from the first hole 461 to the 
second hole 462, the suture material 50 is cut. 
Since the outer tube 20 and the cutting assembly 48 are coupled, and the 
impelling member 30 and the loop support member 40 are also coupled, a 
relative rotation of the outer tube 20 versus the impelling member 30 will 
transmit this relative rotation to the cutting assembly 48 and the loop 
support member 40. 
Protruding into the cutting assembly's bore 486 are third and fourth 
alignment pins (not shown), which are radially spaced at approximately 180 
degrees and are spaced from the distal end 484. The third and fourth pins 
are positioned and dimensioned so that, when the cutting assembly's distal 
end 484 is adjacent the loop support member's shoulder 456, the pins 
engage the cutouts 465,466 in the distal portion 450 and prevent relative 
rotation therebetween beyond the radial extent of the cutouts 465,466. 
The device 10 is utilized to ligate a piece of tissue and cut the loop 506 
from the device 10 as follows: 
The device 10 is assembled and loaded (FIGS. 7, 8, and 13-16) by threading 
suture material 50 onto the loop support member 40 as described, placing 
the cutting assembly 48 over the loop support member 40, and affixing the 
suture material free end 502 and screw 410 adjacent the loop support 
member's proximal end 404. 
The outer tube 20, with the first toroidal member 222, first grasping 
member 210, and locking member 24 affixed thereto, is mated to the loop 
support member 40 by inserting the tab 216 into the cutout 480 until the 
protrusion 217 snaps into the dimple 492. 
The impelling member 30 is mated with the second toroidal member 328, 
second grasping member 316, rod 33, actuator 36, and cap 324 as described 
above. The impelling member's distal end 302 is inserted into the outer 
tube's bore 208, and the unit is aligned so that the rod 33 may be 
inserted into the locking member's bore 242. In order to load, the 
actuator 36 is turned to the loading position, painted white in an 
exemplary model, and the locking member 24 is turned to the "unlimited 
movement" position, also painted white in the exemplary model. When the 
impelling member 30 is in place, the locking member 24 is turned to the 
"locked" position, painted red in the exemplary model, to prevent 
accidental firing of the unit. 
The device 10 is then inserted into the surgical site, typically through a 
trocar placed through an incision into a body cavity, although this use is 
not intended as limiting. A grasping tool 60 is inserted through the 
impelling member bore 308 and the loop support member bore 408 (FIG. 1) 
and is used to grasp a piece of tissue 70 to be ligated (FIG. 2) with its 
jaws 603. Next the grasping tool 60 is pulled in a proximal direction to 
pull the grasped tissue 70 into the loop support member bore 408 (FIG. 3) 
sufficiently far that the distal end 602 of the grasping member's jaws 603 
are proximal of the suture loop 506. 
The device 10 is then prepared for deploying (firing) to ligate the grasped 
piece of tissue 70 (FIGS. 17-21). This is accomplished by moving the 
actuator to the "fire" position, painted green in the exemplary model, and 
rotating the locking member 24 into the "limited movement" position, also 
painted green in the exemplary model. In these positions the impelling 
member 30 and outer tube 20 are free to move toward one another, but not 
to disengage fully. 
The first 210 and the second 316 grasping members are grasped, and 
deploying is accomplished by pushing the second grasping member 316 
distalward relative to the first grasping member 210, until they are as 
close together as possible. Their relative movement will be stopped when 
the locking member 24 is sandwiched between the first 222 and the second 
328 toroidal members. As discussed previously, this movement permits the 
protrusion 342 on the outer surface of the impelling member 30 to snare 
the exposed length 508 of suture material and pull it downward, exerting 
tension on and tightening the suture loop 506, which is pulled off the 
groove 460 to surround and ligate the grasped tissue 70. 
Next the cutting assembly 48 is engaged to cut the suture loop 506 away 
from the remaining suture material 50 (FIGS. 22-25). First the locking 
member 24 is moved back to the "locked" position to prevent relative 
movement between the impelling member 30 and the outer tube 20. Then, as 
the actuator 36 is rotated clockwise from the "firing" to the "cutting" 
position, the cutting assembly 483 is rotated relative to the loop support 
member 40 and is forced in a distal direction, which forces the sharp 
distal end 484 of the cutting assembly 48 against the loop support 
member's shoulder 456, cutting the suture material 50. This releases the 
loop 506 and ligated tissue 70. 
Finally, the device 10 is removed from the site (FIG. 4) leaving the 
ligated tissue 70, loop 506, and knot 504 behind (FIG. 26). This tissue 
can then be left at the site as is, or removed by other means. 
Embodiment Two 
A second embodiment of the device 11 and method of the present invention 
(FIGS. 27-30) is also for delivering a loop of suture material for 
endoscopic ligation. The suture material 50, which preparatory to the 
device's use is loaded onto the device 11, has a free end 502 and a slip 
knot 504 therein for permitting the loop 506 to be tightened (see FIGS. 28 
and 29). The device 11 comprises an outer tube 26, which has a length and 
a longitudinal bore 268 that extends from the distal end 262 to the 
proximal end 264. Within the bore 268 adjacent the proximal end 264 is 
affixed a gasket 261 for maintaining gas pressure and also for aligning 
the impelling member in the bore 268, which will be discussed in the 
following. Atop the proximal end 264 is placed first protective cap 263, 
which is generally formed of a plastic material and also has a bore 265. 
Cap 263 serves to shield the proximal end 264 of the outer tube 26, which, 
if the outer tube 26 is made of metal, could pose a risk to the surgeon. 
A first grasping member 270 is affixed adjacent the proximal end 264, which 
in the embodiment shown comprises a handle having a generally circular 
portion 272 and a downwardly curving portion 274 extending therefrom. The 
circular portion 272 is dimensioned to permit the insertion of a finger, 
generally a middle finger, of the surgeon; the curving portion 274 is 
dimensioned to permit the bracing of a finger, generally a third finger, 
of the surgeon. 
Device 11 further comprises an impelling member 37 that has a distal 
portion 376 dimensioned to freely slide within the outer tube bore 268, a 
distal end 372, a proximal end 374, and a longitudinal bore 378. Bore 378 
extends from the distal end 372 to the proximal end 374 and is dimensioned 
to permit the passage of a grasping tool 60 therethrough, as described 
above for the first embodiment. 
In general the impelling member 37 is slidable within and relative to the 
outer tube bore 268 between a first position (FIG. 27) wherein the 
impelling member distal end 372 resides within the outer tube bore 268 and 
a second, more distal, position (FIG. 30) wherein the impelling member 
distal end 372 is generally adjacent, or may protrude beyond, the outer 
tube distal end 262. This will facilitates a mating of a loop support 
member 42 to the impelling member 37 utilizing an "L"-shaped notch 380 in 
the distal end 372. The distalmost portion 382 of the notch 380 is 
generally parallel to the long axis of the outer tube 26. The 
cross-portion 384 of the notch 380 is generally perpendicular to the 
distalmost portion 382. Notch 380 in the embodiment shown communicates 
with the impelling member bore 378. 
Adjacent the "L"-shaped notch 380 and extending from the distal end 372 is 
slot 381, which also communicates with the bore 378. 
Atop the impelling member's proximal end 374 is placed second protective 
cap 357, which is generally formed of a plastic material and also has a 
bore 358. Cap 357 serves to shield the proximal end 374 of the impelling 
member 37, as discussed above with respect to the outer tube 26 for 
protecting the surgeon. 
A second grasping member 396 is affixed adjacent the proximal end 374, 
which in the embodiment shown comprises a handle having a generally 
circular portion 398. The circular portion 398 is dimensioned to permit 
the insertion of a finger, generally a thumb, of the surgeon. When used in 
concert, the first 270 and the second 396 grasping members permit the 
surgeon to slide the impelling member 37 relative to the outer tube 26 in 
order to deploy the device 11, the details of which will be discussed in 
the following. 
The device 11 further comprises a generally cylindrical loop support member 
42 that has a proximal portion dimensioned to reside at least partially 
within the outer tube bore 268 (see FIGS. 28 and 29). The loop support 
member 42 also has a longitudinal bore 428 extending from the distal end 
422 to the proximal end 424 that communicates with the impelling member 
bore 378 when those two elements are connected together. In a preferred 
embodiment the loop support member 42 has a protrusion 430 extending into 
the bore 428 and adjacent the proximal end 424 that is positioned and 
dimensioned to slide within the `L`-shaped notch 380. Mating is 
accomplished by lining up the protrusion 430 with the notch distalmost 
portion 382, pushing the two elements together until the end of the 
distalmost portion 382 is reached, and twisting the loop support member 42 
so that the protrusion 430 tracks along the notch cross-portion 384, 
thereby locking the elements together. 
When the loop support member 42 is mated with the impelling member 37, 
impeller slot 381 is generally aligned with loop support member slot 432. 
The suture material 50 is loaded onto and supported on the loop support 
member 42 as follows: Adjacent the distal end 422 and adjacent the loop 
support member bore 428 is an inner circumferential groove 440 adapted to 
retain the suture material loop 506 and slip knot 504 thereon when the 
loop 506 is not under tension. In the preferred embodiment, a wider 
section 442 of the groove 440 is provided for retaining the slip knot 504. 
Thus the loop 506 when loaded encircles the loop support member bore 428. 
When tension is applied to the free end 502, the groove 440 is shaped to 
permit the loop 506 and slip knot 504 to slide off the groove 440 for 
tightening. 
In order to affix the free end 502 of suture material 50 to the loop 
support member 40, a second bore 444 generally parallel to the first bore 
428 is provided that extends from the proximal end 424 to the distal end 
422. This second bore 444, which is preferably located so as to have its 
distal end 448 emerge into the wider groove section 442, is dimensioned to 
permit suture material 50 to pass therethrough, but to block the passage 
of the slip knot 504. Thus, if tension is applied to the free end 502 of 
suture material 50 emerging from the proximal end 446 of the second bore 
444, the slip knot 504 is retained adjacent the distal end 448 of the 
second bore 444, and the loop 506 is tightened. The second bore 444 is 
smaller than the first bore 428, which is dimensioned to permit a grasping 
tool 60 to pass therethrough. 
The loop support member 42 further has a notch 432 that communicates with 
the first bore 428 and is positioned adjacent the proximal end 424. The 
notch 432 is also positioned so as to have the second bore 444 on a first 
side 433 of the notch 432. 
The suture material free end 502 is affixed adjacent the second side 434 of 
the notch 432. In a particular embodiment a pin 435 pierces the free end 
502 and is inserted into a third bore 436 in the loop support member 42 
that is also generally parallel to the first bore 428. Therefore, when in 
use the suture material free end 502 emerging from the second bore 
proximal end 446 is affixed so as to cross the notch 432 from the notch 
first side 433 to the notch second side 434, which makes a section 508 of 
suture material 50 available to the exterior of the loop support member 
40. 
In order to snare the exterior section 508 of suture material 50, a hook 
282 is affixed within the outer tube bore 268 in such an axial position 
that, when the impelling member 37 is pulled into the first position 
within the outer tube bore 268, the loop support member 42 having been 
mated to the impelling member 37, the hook 282 snares the suture material 
exterior section 508, which sets the device 11 for deploying. The hook 282 
is also positioned to ride within the impeller slot 381. The device 11 is 
deployed by pushing the impelling member 37 in a distal direction relative 
to the outer tube 26, pulling the snared exterior section 508 of suture 
material 50 and thereby tightening the loop 506 (FIG. 30). 
The device 11 is utilized with a grasping tool 60 as follows: The grasping 
tool 60 is inserted through the impelling member bore 378; the grasping 
tool 60 is used to grasp a piece of tissue 70 to be ligated; and the 
device 11 is deployed to ligate the grasped piece of tissue 70. This is 
analogous to the procedure discussed above for the first embodiment. 
Means for limiting the distalward sliding is accomplished by the abutment 
of the circular portions 272,398 of the first 270 and second 396 grasping 
members (see FIG. 30). 
It may be appreciated by one skilled in the art that additional embodiments 
may be contemplated, including those having alternate means of retaining 
the loop of suture material in an opened configuration, as well as 
alternate means of affixing the suture material free end to the outer tube 
and means of snaring the exposed length of suture material. 
In the foregoing description, certain terms have been used for brevity, 
clarity, and understanding, but no unnecessary limitations are to be 
implied therefrom beyond the requirements of the prior art, because such 
words are used for description purposes herein and are intended to be 
broadly construed. Moreover, the embodiments of the apparatus illustrated 
and described herein are by way of example, and the scope of the invention 
is not limited to the exact details of construction. 
Having now described the invention, the construction, the operation and use 
of preferred embodiment thereof, and the advantageous new and useful 
results obtained thereby, the new and useful constructions, and reasonable 
mechanical equivalents thereof obvious to those skilled in the art, are 
set forth in the appended claims.