BRIEF DESCRIPTION OF THE DRAWINGS
The features of the present invention which are believed to be novel are set forth with particularity in the appended claims. The invention, together with further objects and advantages thereof, may best be understood by making reference to the following description taken in conjunction with the accompanying drawings, in the several figures of which like reference numerals identify like elements, and wherein:
FIG. 1 is a perspective side view with portions cut away of a stomach and a fastener deployment assembly including a fastener deployment device and a snare according to a first embodiment of the invention in use to deploy at least one fastener to maintain a gastroesophageal valve (GEV) therein;
FIG. 2 is a perspective side view with portions cut away of the stomach and the fastener deployment assembly of FIG. 1 during an initial stage of its use;
FIG. 3 is a perspective side view with portions cut away of the stomach and the fastener deployment assembly of FIG. 1 during a further stage of its use to deploy a fastener;
FIG. 4 is a perspective side view with portions cut away of the stomach and the fastener deployment assembly of FIG. 1 as the snare captures the fastener deployment device during a further stage of its use to deploy a fastener;
FIG. 5 is a perspective side view with portions cut away of the stomach and the fastener deployment assembly of FIG. 1 during a further stage of its use and as a fastener is being delivered for deployment;
FIG. 6 is a perspective side view with portions cut away of the stomach and the fastener deployment assembly of FIG. 1 showing the fastener deployment device being captured during an initial stage of an alternative method of capture;
FIG. 7 is a perspective side view with portions cut away of the stomach and the fastener deployment assembly of FIG. 1 showing the fastener deployment device being captured according to the alternative method of capture;
FIG. 8 is a side plan view of a fastener deployment assembly according to a further embodiment of the invention;
FIG. 9 is a perspective side view with portions cut away of a stomach and the fastener deployment assembly of FIG. 8 during an initial stage of its use;
FIG. 10 is a perspective side view with portions cut away of the fastener deployment assembly of FIG. 8 during a further stage of its use and as a fastener is being deployed;
FIG. 11 is a perspective side view with portions cut away of the fastener deployment assembly of FIG. 8 after the fastener has been deployed;
FIG. 12 is a perspective side view with portions cut away of a further fastener deployment assembly according to another embodiment of the invention;
FIG. 13 is a perspective side view, with portions cut away, of still another fastener deployment assembly embodying the invention; and
FIG. 14 is a perspective side view showing how the fastener deployment assembly may be employed to deploy a fastener.
DETAILED DESCRIPTION
FIG. 1 is a perspective side view with portions cut away of a stomach 10 and a fastener deployment assembly 30 embodying the present invention. The assembly generally includes a fastener deployment device 30 and a snare 20 shown in use to deploy at least one fastener for maintaining a gastroesophageal valve 12.
The fastener deployment device 30 includes an elongated body 32. The body 32 has a distal end 34 extending into the stomach 10. The body includes a through channel 36 that sliding receives the snare 20. The body further has a fastener-directing channel 38 that directs a fastener 50 into the stomach tissue to be fastened.
The snare 20 includes an elongated member 22, a catheter 24, and a cable 40 that forms a cable loop 26. The elongated member is preferably an endoscope having a distal end 23, a proximal end (not shown) and a lumen 25 that receives the catheter 24. The endoscope 22 may thus be used for both introducing the snare into the stomach and providing visualization of the fastener deployment process.
The fastener 50 may take the form of the fasteners and be deployed as shown and described, for example, in co-pending application Ser. No. 11/043,903, filed Jan. 25, 2005, for SLITTED TISSUE FIXATION DEVICES AND ASSEMBLIES FOR DEPLOYING THE SAME, which application is incorporated herein in its entirety. To that end, the fastener 50 is carried on a deployment wire or stylet 52 and the leading member thereof is pushed by a pusher 54 into and through the tissue. In accordance with aspects of the invention, during the fastener deployment process, and as illustrated in FIG. 1, the fastener deployment device 30 and the tissue of valve 12 are bound together by the snare 20. This provides stabilization of the tissue to permit the fastener 50 to be accurately placed and forced through the tissue. FIGS. 2-5 illustrate a manner in which the fastener deployment of FIG. 1 may be achieved.
In FIG. 2 it may be seen that the endoscope 22 has been passed down the elongated member 32 and retroflexed to provide visualization of the process. Thereafter, the catheter 24 is pushed out of the distal end of the endoscope 22. The cable loop 26 is then pushed out of the distal end of the catheter 24.
The catheter 24 preferably has shape-memory so that as the catheter 24 is advanced further distally, it will assume the shape illustrated in FIG. 3. More specifically, as the catheter 24 is played out, it curls around to cause the cable loop 26 to be loosely received over the endoscope 22.
Referring now to FIG. 4, with the cable loop 26 loosely received on the endoscope 22, the whole assembly may now be translated in an oral or proximal direction. The assembly is translated enough to position the cable loop 26 around both the fastener deployment device 30 and the tissue 12. The assembly is now ready to bind the fastener deployment device 30 and the tissue 12 together.
As will be noted in FIG. 5, the cable loop is now pulled tight to bind the fastener deployment device 30 to the tissue 12. A fastener 50 may now be pushed down the stylet 52 by the pusher 54 within the channel 38 to the tissue as shown in FIG. 1 for deployment.
FIGS. 6 and 7 show another way in which the cable loop 26 may be manipulated to loosely receive the fastener deployment device 30 and the tissue 12. Once again the endoscope 22 is retroflexed to permit visualization. Instead of plying out the catheter 24, the proximal ends 27 of the cable loop 26 are twisted around as indicated by the arrows 28. This will cause the loop 26, which is preferably preformed in a bent structure, to swing around as shown in FIG. 7 from the dashed line position to the solid line position. The cable loop 26 is now loosely received over the fastener deployment device 30 and the tissue 12. The assembly is now ready to deploy a fastener as shown in FIGS. 1 and 5.
Referring now to FIG. 8, it shows another embodiment of the present invention. The assembly 100 of FIG. 8 generally includes a snare 120 and a fastener deployment device 130.
The snare 120 includes an elongated conduit 122 that guides two legs of a cable 140 that form a loop 126. The snare also includes a spreader block 160. The spreader block 160 has diverging lumens 162 and 164 that terminate at a spreader surface 165. The diverging lumens 162 and 164 increase the spacing between the ends 142 and 144 of the cable loop 126.
The fastener deployment device 130 includes a conduit 132 that extends down the conduit 122. The conduit 132 terminates with an enlarged section 133 at the spreader surface 165.
As will be seen subsequently, tissue to be fastened is pulled through the cable loop 126. The tissue engaging the spreader surface 165 is caused to spread to form tissue layers 170 and 172. The cable 140 may then be drawn tight causing the cable loop 126 to securely hold the tissue layers against the spreader surface 165. Now, the stylet 152 may be guided by the conduit 132 into and through the tissue layers 170 and 172. The fastener 150 is then pushed down the stylet 152 by the pusher 154 into the tissue layers 170 and 172. The enlarged portion 133 of the conduit 132 is provided to accommodate the fastener 150 and to provide space for its deployment.
Referring now to FIGS. 9 through 11, they show a manner in which the assembly 100 of FIG. 8 may be employed to fasten tissue layers of a stomach 10. In FIG. 9, it will be noted that the conduit 122 has been fed into the stomach 10. The assembly 100 also includes a mechanical retractor 180 comprising another conduit or catheter 188, a first cable 182, and a second cable 186. The first cable 182 extends through the cable loop 126 and terminates in a tissue grabber, such as a helical coil 184 that, when engaged with and rotated against tissue, grabs the tissue. Accordingly, as seen in FIG. 9, the helical coil 184 has been rotated against the tissue of the stomach 10 and has grabbed the tissue. As may be appreciated, other forms of tissue grabbers may be employed in place of the helical coil 184. The second cable 186 extends down the conduit 122. It serves to provide guiding assistance to the first cable 182 when the helical coil is directed to the tissue.
The cable 182 is now used to pull the tissue through the cable loop 126. As may be seen in FIG. 10, the tissue is pulled through the cable loop 126 and along side the spreader block and the conduit 122. The spreader surface 165 forms a snare base that exerts a force against the tissue. Here, that force is in the direction of travel by the fastener 150. The tissue is pulled by the cable 182 at an angle and in a direction having a component opposed to the direction of the force applied to the tissue by the snare base. In the process, the tissue layers 170 and 172 are formed against the spreader surface 165. The cable loop 126 may now be drawn tight and the fastener 150 may be deployed as previously described.
FIG. 11 shows the fastener 150 deployed through the tissue layers 170 and 172. The cable loop 126 has been loosened to permit the fastened tissue to be removed from the snare after the helical coil 184 is counter-rotated out of the tissue.
FIG. 12 shows another embodiment of the invention. The assembly 110 there shown is substantially similar to the assembly 100 except for the fact that the snare 112 of the assembly 110 includes an opposing block 190 that opposes spreader block 160 and that the assembly 110 employs an alternate form of mechanical tissue retractor 192. Firstly, with respect to the mechanical retractor 192, it will be seen that it includes a tissue forceps 194 instead of a helical coil for grabbing the tissue. With respect to the opposing block 190, it provides an opposing surface 195 juxtaposed to the surface 165 of the spreader block 160 to confine the tissue to be fastened there between. The opposing block 190 has a hollowed out portion 196 that receives the tip 153 of the stylet 152 to protect surrounding tissue from the tip 153 and to provide space for the fastener 150. In use, the operation of the assembly 110 is substantially the same as that described with respect to the assembly 100 of FIGS. 9 through 11.
Referring now to FIGS. 13 and 14, they illustrate another assembly 200 embodying the invention. Here, the assembly includes a snare 220 comprising a pair of cable loops 226 and 326 formed from cables 240 and 340 respectively. The legs of the cables 240 and 340 extend down a conduit 222 the includes a channel 238 to accommodate the fastener deployments stylet 252 and pusher 254 to enable deployment of fastener 250. The channel extends down the conduit 222 to place the fastener in between the cables loops 226 and 326.
FIG. 13 schematically shows the assembly 200 in use. Here it may be seen that a mechanical retractor 280 includes a cable 282 and helical coil 284. They have been employed to pull the tissue layers 270 and 272 through both cable loops 226 and 326. The two spaced cable loops 226 and 326 function together to prevent the tissue form slipping out of the grip of the snare 220. The snare 220 thus holds the tissue against the channel to permit a fastener to be deployed by the stylet 252 and pusher 254 as previously described.
While the invention has been described by means of specific embodiments and applications thereof, it is understood that numerous modifications and variations may be made thereto by those skilled in the art without departing from the spirit and scope of the invention. It is therefore to be understood that within the scope of the claims, the invention may be practiced otherwise than as specifically described herein.