DETAILED DESCRIPTION OF THE INVENTION

[0033] In accordance with the principles of the present invention, methods and apparatus are provided for treating obesity by approximating the walls of a gastrointestinal lumen to narrow the lumen, thus reducing the area for absorption in the stomach or intestines. More particularly, the present invention involves an endoscopic apparatus that engages a tissue wall of the gastrointestinal lumen, creates a tissue fold and disposes an anchor assembly through the tissue fold. Preferably, the anchor assembly is disposed through the muscularis and/or serosa layers of the gastrointestinal lumen. In operation, the distal tip of the probe engages the tissue, then moves the engaged tissue to a proximal position relative to the catheter tip, thereby providing a substantially uniform plication of predetermined size.

[0034] Formation of a tissue fold preferably is accomplished using two tissue contact points that are separated by a linear or curvilinear distance, wherein the separation distance between the tissue contact points affects the length and/or depth of the fold. In operation, a tissue grabbing assembly engages the tissue wall in its normal state (i.e., non-folded and substantially flat), thus providing a first tissue contact point. The first tissue contact point then is moved to a position proximal of a second tissue contact point to form the tissue fold. An anchor assembly then may be extended across the tissue fold at the second tissue contact point.

[0035] More preferably, the first tissue contact point is used to engage and then stretch or rotate the tissue wall over the second tissue contact point to form the tissue fold. The tissue fold is then articulated to a position so that a portion of the tissue fold overlies the second tissue contact point at an orientation that is substantially normal to the tissue fold. An anchor then is delivered across the tissue fold at or near the second tissue contact point.

[0036] Referring to FIGS. 1A and 1B , apparatus 10 of the present invention comprises torqueable catheter 11 having distal region 12 from which first and second interconnected flexible tubes 13 and 14 extend, and proximal region 15 having handle 16 and actuator 17 . Catheter 11 is configured to be inserted through a patient's mouth and esophagus and into the gastrointestinal lumen. Tissue grabbing assembly 18 is disposed on the distal end of flexible tube 13 , and is coupled to actuator 17 via control wire 19 that extends through flexible tube 13 .

[0037] As better illustrated in FIG. 1 B, flexible tubes 13 and 14 are connected via hinge assembly 20 that comprises link 21 attached to flexible tube 13 at pivot point 22 and attached to flexible tube 14 at pivot point 23 . Hinge assembly 20 prevents tissue grabbing assembly 18 from moving more than a predetermined distance relative to distal end 24 of flexible tube 14 .

[0038] Still referring to FIG. 1 B, flexible tubes 13 and 14 preferably include bendable sections 25 and 26 , respectively, that comprise a plurality of through-wall slots 27 to enhance flexibility of the tube. Preferably, flexible tubes 13 and 14 are made from stainless steel with an etched or laser-cut slot pattern. More preferably, the slot pattern is a sinusoidal repeating pattern of slots perpendicular to the longitudinal axis of tubes 13 and 14 .

[0039] Referring to FIGS. 2A and 2B , tissue grabbing assembly 18 comprises pair of jaws 28 a, 28 b arranged to rotate about pivot point 29 between an open configuration ( FIG. 2A ) and a closed configuration ( FIG. 2B ). Control wire 19 is coupled via pivot point 30 to arms 31 a and 31 b. Arms 31 a and 31 b are in turn pivotally coupled to jaws 28 a and 28 b, respectively, at pivot points 32 a and 32 b. Each of jaws 28 a and 28 b preferably includes sharpened teeth 33 disposed near its distal ends to facilitate grasping of the tissue wall of the GI lumen. retraction of control wire 19 to stretch tissue wall W and create tissue fold F. During this movement of flexible tube 13 , link 21 of hinge assembly 20 causes tissue grabbing assembly 18 to move from a position distal to distal end 24 of flexible tube 14 , to a position proximal of distal end 24 of flexible tube 14 . Bendable sections 25 and 26 of flexible tubes 13 and 14 , respectively, accommodate any lateral motion caused by operation of hinge assembly 20 . Advantageously, formation of fold F facilitates the penetration of the tissue wall by a needle and subsequent delivery of an anchor assembly, as described hereinafter.

[0040] Referring to FIG. 3 D, additional proximal movement of actuator 17 causes flexible tubes 13 and 14 to buckle at bendable sections 25 and 26 . The force applied to flexible tube 13 via control wire 19 and actuator 17 is transmitted to the distal tip 24 of the flexible tube 14 by hinge assembly 20 . Preferably, flexible tube 14 is configured so that distal tip 24 contacts, and is substantially perpendicular, to tissue fold F at contact point P 2 . As illustrated in FIG. 3 E, once tissue fold F is stretched across distal tip 24 of flexible tube 14 , sharpened needle or obturator 34 may be extended from distal tip 24 of flexible tube 14 to pierce all four layers of the tissue wall W. Sharpened needle or obturator 34 is inserted via inlet 35 to flexible tube 14 on handle 16 (see FIG. 1A ).

[0041] As discussed above, the GI lumen comprises an inner mucosal layer, connective tissue, the muscularis layer and the serosa layer. To obtain a durable purchase, e.g., in performing a stomach reduction procedure, the staples or anchors used to achieve reduction of the GI lumen must engage at least the muscularis tissue layer, and more preferably, the serosa

[0042] Control wire 19 is coupled to actuator 17 of handle 16 so that translation of the wire within flexible tube 13 causes the jaws to open or close. In particular, urging control wire distally (as indicated by arrow A in FIG. 2A ) moves pivot point 30 distally, thereby forcing the jaws to open. Urging control wire 19 proximally (as indicated by arrow B in FIG. 2B ) moves pivot point 30 proximally, thereby forcing the jaws to close together. In alternative embodiments, tissue grabbing assembly 18 may comprise a grappling hook or fork, or plurality of needles coupled to the distal end of flexible tube 13 .

[0043] Flexible tube 14 is affixed to and immovable within catheter 11 , while flexible tube 13 is coupled to catheter 11 only via hinge 20 . Accordingly, when control wire 19 is extended in the distal direction, flexible tube 13 is carried in the distal direction. When control wire 19 is retracted in the proximal direction, flexible tube remains stationary until jaws 28 a and 28 b close together, after which further retraction of control wire 19 by moving actuator 17 causes flexible tube to buckle in bendable region 25 , as described hereinafter.

[0044] Referring now to FIGS. 1 and 3 A- 3 E, operation of apparatus 10 is described to create a tissue fold in a tissue wall of a GI lumen. In FIG. 3 A, distal region 12 of catheter 11 is positioned within a patient's GI lumen transesophageally, and jaws 28 a and 28 b of tissue grabbing assembly 18 are opened by moving actuator 17 to the distal-most position on handle 16 . As depicted in FIG. 3 B, actuator 17 may then be moved proximally until the jaws of tissue grabbing assembly 18 engage a portion of tissue wall W at contact point P 1 .

[0045] Referring to FIG. 3 C, after the tissue wall has been engaged at contact point P 1 , flexible tube 13 is urged proximally within catheter 11 by further proximal layer as well. Advantageously, stretching of tissue fold F across distal tip 24 permits an anchor to be ejected through both the muscularis and serosa layers, thus enabling durable gastrointestinal tissue approximation.

[0046] As depicted in FIG. 3 E, after tissue fold F is stretched across distal tip 24 of flexible tube 14 to form contact point P 2 with tissue wall W, needle 34 may be extended from distal tip 24 and through tissue fold F. Because needle 34 penetrates the tissue wall twice, it exits within the gastrointestinal lumen, thus reducing the potential for injury to surrounding organs. Once the needle has penetrated tissue fold F, an anchor assembly is ejected through distal tip 24 as described hereinbelow.

[0047] With respect to FIGS. 4 A- 4 C, a first embodiment of an anchor assembly suitable for use with the apparatus of the present invention is described. Anchor assembly 36 comprises T-anchor assembly having distal rod 38 a and proximal rod 38 b connected by suture 39 . The precise shape, size and materials of the anchors may vary for individual applications. In addition, the suture material also may vary for individual applications. By way of example, the suture material may consist of monofilament wire, multifilament wire or any other conventional suture material. Suture 39 extends through a pair of through holes 40 in each rod, thereby forming a loop. Alternatively, suture 39 may be attached to the rods via an eyelet or using a suitable adhesive. Preferably, through-holes 40 are located near the center of the rods 38 a and 38 b.

[0048] Referring to FIG. 4 B, rods 38 a and 38 b may be delivered through needle 34 (see FIG. 3E ) using push rod 42 . Push rod 42 is adapted to freely translate through flexible tube 14 and needle 34 . Push rod 42 is preferably flexible, so that it may slide through bendable section 26 of flexible tube 14 . In addition, push rod 42 may include notch 43 near its distal end to facilitate grasping and tensioning suture 39 after anchor delivery.

[0049] During anchor delivery, the longitudinal axis of distal rod 38 a is substantially parallel to the longitudinal axis of needle 34 . However, once distal rod 38 a is ejected from needle 34 , suture tension induces the rod to rotate approximately 90 degrees about its longitudinal axis, so that its longitudinal axis is substantially perpendicular to the longitudinal axis of needle 35 . This rotation of distal rod 38 a prevents it from being pulled back through tissue wall W.

[0050] Referring to FIG. 4 C, once rod 38 a is ejected on the distal side of fold F, needle 35 is retracted and push rod 42 is used to eject rod 38 b on the proximal side of tissue fold F. Like distal rod 38 a, tension in the suture causes proximal rod 38 b to rotate about 90 degrees once it is ejected from the needle. Notch 43 in push rod 42 then may be employed to tighten suture 39 by any of a variety of mechanisms.

[0051] Referring now to FIG. 5 A, according to other embodiments, the anchor assembly comprises a T-anchor assembly suitable to be disposed over obturator 50 . More particularly, distal rod 38 a includes through-hole 51 dimensioned for the passage of obturator tip 52 , and obturator 50 is translatably inserted through flexible tube 14 via inlet 35 of handle 16 (see FIG. 1A ). Proximal rod 38 b may be a solid rod that does not include a through-hole for passage of obturator 50 . Alternatively, proximal rod 38 b may include a through-hole for the passage of the obturator. Preferably, obturator tip 52 is sharpened to facilitate tissue penetration.

[0052] With respect to FIG. 5 B, once rod 38 a is ejected on the distal side of fold F, it rotates into a position substantially parallel to tissue wall W and perpendicular to the longitudinal axis of the obturator. Obturator 50 then is retracted and proximal rod 38 b is ejected from flexible tube 14 . More particularly, when flexible tube 14 is retracted from tissue wall W, proximal rod 38 b is pulled through distal tip 24 . Proximal rod 38 b then rotates substantially 90 degrees as it is ejected from flexible tube 14 so that rod 38 b is urged against tissue wall W.

[0053] Referring to FIG. 6 A, according to further embodiments, anchor assembly 55 comprises a T-anchor assembly similar to the embodiment depicted in FIG. 4A . However, anchor assembly 55 includes fine wire tether 56 that may be twisted to maintain the tension between rods 38 a and 38 b.

[0054] With respect to FIG. 6B, a method of delivering anchor assembly 55 is described. Initially, distal rod 38 a is delivered across both tissue walls using needle 34 . The needle then is retracted to release distal rod 38 a so that it engages the tissue wall. Next, needle 34 is retracted to release proximal rod 38 b, so that it too rotates into engagement with the tissue wall. A proximal portion of the wire tether is captured by notch 43 of push rod 42 (see FIG. 4B ), and the push rod is rotated to cause proximal rod 38 b to clamp down on the tissue fold. Because wire tether 56 is twisted by rotation of push rod 42 , it maintains the desired force on the tissue walls.

[0055] FIGS. 7 A- 7 D depict other alternative anchor embodiments suitable for use with the methods and apparatus of the present invention. Referring to FIG. 7 A, articulating anchor 60 includes semi-cylindrical base 61 , rod 62 and suture 39 . Rod 62 rotates about pivot point 63 (as indicated by arrow 64 ) between an expanded position (shown in FIG. 7A ) and a reduced profile position, wherein rod 62 pivots within the semi-cylindrical base 61 . Articulating anchor 60 may be delivered through a tissue fold using needle 34 described hereinabove with respect to FIG. 3E . Preferably, articulating anchor 60 is biased in the expanded position so that it automatically expands once it is ejected from the needle.

[0056] With respect to FIGS. 7B and 7C the anchors of the present invention also may comprise a pair of oblong bodies connected by at least one suture. In FIG. 7 B, anchor 65 comprises elliptical ring 66 having sutures 39 attached at substantially opposite sides of the ring. In FIG. 7 C, anchor 68 comprises angle bracket 69 having a pair of through-holes 70 for suture 39 . In FIG. 7 D, anchor 71 comprises oblong bead 72 having a pair of through-holes 73 for suture 39 . All three anchors 65 , 68 and 71 have a first dimension (e.g., width) that is substantially larger than a second dimension (e.g., height). This dimensional difference necessitates that anchors 65 , 68 and 71 be inserted within needle (e.g., needle 34 of FIG. 3E ) in a particular orientation. Once the anchor is ejected through a tissue wall, tension on suture 39 forces the anchor to rotate so that it cannot be pulled back through the tissue wall. As will be understood by those of skill in the art, numerous other anchors may be employed without departing from the scope of the present invention.

[0057] Referring now to FIG. 8 A, an alternative embodiment of apparatus for forming a tissue fold, constructed in accordance with the principles of the present invention, is described. Apparatus 75 comprises treadmill assembly 76 disposed at distal tip 74 of flexible tube 77 . Flexible tube 77 is configured to be inserted through a patient's mouth, esophagus and into the stomach. Treadmill assembly 76 comprises conveyor 80 that circles around a pair of hubs 81 a and 81 b. Hubs 81 a and 81 b rotate about axles 82 a and 82 b, respectively, and are interconnected by bracket 83 . A plurality of barbs or needles 85 are disposed at substantially regular intervals around the circumference of conveyor 80 .

[0058] Flexible tube 77 preferably includes a plurality of through-wall slots 86 to enhance flexibility of the tube, yet maintain torqueability. Preferably, flexible tube 77 is made from stainless steel with an etched or laser-cut slot pattern. Preferably, the slot pattern is a sinusoidal repeating pattern of slots perpendicular to the longitudinal axis of the tube.

[0059] Referring to FIGS. 8 and 9 , transmission of motive force to treadmill assembly 76 is described. In particular, drive shaft 102 disposed within flexible tube 77 is coupled to a manual knob or motor located at the proximal end of the catheter. The distal tip of drive shaft 102 is provided with beveled gear 103 that meshes with beveled gear 104 provided on axle 82 b. Accordingly, rotation of beveled gear 103 is transmitted to beveled gear 104 , thereby causing axle 82 b to rotate. Axle 82 b in turn rotates hub 81 b, actuating conveyor 80 . The direction of conveyor 80 may be reversed by reversing the rotation of drive shaft 102 .

[0060] Referring again to FIGS. 8 A- 8 D, a method of forming a gastrointestinal tissue fold F using apparatus 75 is described. In FIG. 8 A, flexible tube 77 is positioned transesophageally so that treadmill assembly 76 contacts tissue wall W. Preferably, contact should be made at an angle relative to the tissue wall W. For example, an angle of approximately 45 degrees is depicted in FIG. 8 A, while many other angles may be used without departing from the scope of the present invention.

[0061] When treadmill assembly 76 contacts tissue wall W, needle 85 engages the tissue at contact point P 1 as the needle moves around distal hub 81 a. As depicted in FIG. 8 B, as the needle moves away from distal hub 81 a , tissue wall W is pulled towards proximal end 81 b, thereby forming a small tissue fold F. As the treadmill assembly continues to turn, subsequent needles 85 engage the tissue wall so that it becomes securely engaged to treadmill assembly 76 along the length of conveyor 80 .

[0062] As depicted in FIG. 8 C, once tissue wall W is securely engaged to treadmill assembly 76 , distal end 74 of flexible tube 77 may be articulated in bendable section 90 , thereby moving treadmill assembly 76 away from tissue wall W. The articulation of flexible tube 77 may be accomplished using a control wire and actuator disposed at the proximal end of the catheter, as described for the embodiment of FIGS. 1 . By moving the treadmill assembly away from tissue wall W, additional tissue is pulled proximally and tissue fold F becomes elongated.

[0063] In FIG. 8 D, tissue fold F is stretched across bendable section 90 of flexible tube 77 to create contact point P 2 . This permits a sharpened needle or obturator to be extended through one of slots 86 of bendable section 90 and across all four layers of the tissue wall W. Advantageously, stretching of tissue fold F across bendable section 90 permits an anchor to be ejected through both the muscularis and serosa layers, thus providing a durable foundation for gastrointestinal tissue approximation. For example, needle 92 may be extended through slot 86 in bendable section 90 , and through the base of tissue fold F, and an anchor assembly (such as described with respect to FIGS. 4 A- 4 C) may be ejected from needle 92 to secure the fold. Alternatively, an obturator (such as described with respect to FIGS. 5A and 5B ) may be used to pierce the tissue fold at contact point P 2 and deliver the anchor assembly. Treadmill assembly 76 may be disengaged from tissue wall W by reversing the rotation of proximal hub 81 b.

[0064] Referring now to FIG. 1A, a further alternative embodiment of apparatus for forming a tissue fold in accordance with the principles of the present invention is described. Apparatus 100 comprises tissue grabbing assembly 18 ′ coupled to the distal end of a flexible tube 77 ′, such as described with respect to the embodiment of FIG. 8 . Flexible tube 77 ′ preferably includes a plurality of through-wall slots 86 ′ to enhance flexibility of the tube, yet maintain torqueability. In addition, flexible tube 77 ′ may be made from stainless steel with an etched or laser-cut slot pattern, such as a sinusoidal repeating pattern of slots perpendicular to the longitudinal axis of the tube.

[0065] Tissue grabbing assembly 18 ′ is similar to that described with respect to the embodiment of FIG. 1 , and comprises a pair of jaws 28 a ′, 28 b ′ arranged to rotate about pivot point 29 ′ between an open configuration and a closed configuration. Each of jaws 28 a ′, 28 b ′ preferably includes sharpened teeth 33 ′ disposed near its distal end to facilitate grasping tissue wall W.

[0066] With respect to FIG. 10 A, tissue grabbing assembly 18 ′ is positioned transesophageally adjacent to tissue wall W and jaws 28 a ′, 28 b ′ are moved to the open position. Tissue grabbing assembly 18 ′ then is moved into contact with tissue wall W. As depicted in FIG. 10 B, tissue grabbing assembly 18 ′ is used to grab the tissue wall at a first contact point P 1 . After capturing a portion of tissue wall W within jaws 28 a ′, 28 b ′, flexible tube 77 ′ is urged proximally to stretch tissue wall W and create tissue fold F.

[0067] Referring to FIG. 10 C, once tissue fold F is formed, the distal end of flexible tube 77 ′ is articulated about bendable section 90 ′ to move tissue grabbing assembly 18 ′ away from tissue wall W. Articulation of flexible tube 77 ′ may be controlled using an actuator disposed at the proximal end of the catheter, thus causing tissue fold F to become elongated.

[0068] In FIG. 10 D, tissue fold F is shown stretched across bendable section 90 ′ so that a sharpened needle or obturator may be extended from one of slots 86 ′ in bendable section 90 ′ and across all four layers of the tissue wall W. Needle 92 ′ then may be extended from slot 86 ′ in bendable section 90 ′ through contact point P 2 and tissue fold F. An anchor assembly (e.g., as described with respect to FIGS. 4 A- 4 C) then may be ejected from needle 92 ′ to secure the fold. Alternatively, an obturator (e.g., as described with respect to FIGS. 5A and 5B ) may be used to pierce the tissue fold at contact point P 2 and deliver the anchor assembly.

[0069] Although preferred illustrative embodiments of the present invention are described above, it will be evident to one skilled in the art that various changes and modifications may be made without departing from the invention. It is intended in the appended claims to cover all such changes and modifications that fall within the true spirit and scope of the invention.