JP2007513717A - Devices and methods for forming and fixing gastrointestinal tissue folds - Google Patents

Abstract

Capturing tissue at a first tissue contact point, the first tissue contact point from the initial position that is distal to or aligned with the second tissue contact point. Gastrointestinal tract by moving to a position proximal to the tissue contact point to form a tissue fold and extending the anchor assembly (36) through the tissue fold from the vicinity of the second tissue contact point. An apparatus and method for forming a tissue fold is provided. Furthermore, an adjustable anchor assembly (36), an anchor delivery system (34), and a guide (1000) capable of fixing the shape, and gastric reduction, gastroesophageal reflux disease treatment, lesion resection, and A method is provided for performing a medical procedure endoscopically for treatment of a bleeding site.

Description

(Background of the Invention)
(1. Field of the Invention)
The present invention relates to methods and devices for forming and securing gastrointestinal ("GI") tissue folds from within a lumen. More particularly, the present invention relates to a method and apparatus for reducing the effective cross-sectional area of the gastrointestinal lumen.

  Morbid obesity is a serious medical condition that is widespread in the United States and other countries. Its complications include hypertension, diabetes, coronary artery disease, cerebral infarction, congestive heart failure, numerous orthopedic problems, and pulmonary valve insufficiency, visibly shortening life expectancy.

  Several surgical techniques have been developed to treat morbid obesity, such as bypassing the absorbing surface of the small intestine and reducing the size of the stomach. These surgeries are difficult to perform in morbidly obese patients because they often have difficulty accessing the digestive tract. In particular, the fat layer found in morbidly obese patients makes direct exposure of the digestive tract with wound retractors difficult, and standard laparoscopic trocars may be inadequate in length.

  In addition, known open surgical procedures can present a number of life-threatening post-operative complications, including irregular diarrhea, electrolyte imbalance, unpredictable weight loss, and anastomosis May result in nutrient-rich sputum reflux proximal to the site. In addition, the sutures or staples often used in these surgical procedures require considerable skill by the clinician to achieve useful use and concentrate considerable force on the small surface area of the tissue, allowing for suturing. It is possible that a thread or staple will tear through the tissue.

  The gastrointestinal lumen comprises four tissue layers, with the mucosa layer being the top tissue layer, followed by the connective tissue, muscle layer, and serosa layer. One problem with conventional gastrointestinal reduction systems is that the anchor (or staple) must engage at least the muscle tissue layer in order to provide the proper foundation. In other words, the mucosal layer and the connective tissue layer are generally not strong enough to support the tensile loads imposed by normal movement of the stomach wall during food intake and processing. In particular, these layers tend to stretch elastically rather than holding the anchor (or staple) firmly in place, and thus into a more rigid muscle and / or serosa layer. Engagement must be done. This challenge of capturing the muscular or serosal layer becomes particularly serious when it is desired to place an anchor or other device through the esophagus rather than by surgery. This is because care must be taken not to accidentally puncture adjacent tissues or organs when penetrating the strong stomach wall.

  In light of the above constraints, it would be desirable to provide a method and apparatus for forming a fold in gastrointestinal tissue that achieves gastric reduction by reconstructing the patient's GI lumen.

  It would be desirable to provide a method and apparatus for forming folds in gastrointestinal tissue using an anchor that can be reconfigured from a reduced delivery profile to a deployed post-deployment profile. .

  It is further desirable to provide a method and apparatus for forming a fold in gastrointestinal tissue, wherein the anchor assembly extends across the gastric fold including the muscle tissue layer and the serosal tissue layer.

  Furthermore, it would be desirable to provide a method and apparatus for forming a fold in gastrointestinal tissue, wherein the anchor assembly is deployed in a manner that reduces the likelihood of damaging nearby organs.

  Still further, it would be desirable to provide a method and apparatus for forming a fold in gastrointestinal tissue that can be usefully used with an anchor assembly even with little clinician skill.

  It would be desirable to provide a method and apparatus for forming a fold in gastrointestinal tissue that facilitates the proximity of multiple folds of tissue.

(Simple Summary of Invention)
In light of the foregoing, it is an object of the present invention to provide a method and apparatus for forming gastrointestinal tissue folds that achieves gastric reduction by shaping a patient's GI lumen. is there.

  Another object of the present invention is to provide a method and apparatus for forming gastrointestinal tissue folds using an anchor that can be reconfigured from a reduced delivery configuration to a deployed deployment configuration. is there.

  Another object of the present invention is a method and apparatus for forming a gastrointestinal tissue fold, wherein the anchor assembly extends through the gastric fold including a muscle tissue layer and a serosal tissue layer. It is to provide.

  It is a further object of the present invention to provide a method and apparatus for forming gastrointestinal tissue folds wherein the anchor assembly is positioned in a manner that reduces the likelihood of damage to nearby organs. It is in.

  Yet another object is to provide a method and apparatus for forming gastrointestinal tissue folds that requires less physician skill to achieve proper use of the anchor assembly. It is in.

  An object is to provide a method and apparatus for forming an intestinal tissue fold that can facilitate the access of multiple tissue folds.

  These and other objects of the present invention are achieved by providing a catheter configured to be advanced into a patient's gastrointestinal lumen to form a gastrointestinal tissue fold. In one preferred embodiment, the catheter comprises a tissue grasping assembly in the distal region, the tissue grasping assembly captures a portion of the tissue wall of the GI lumen at the first tissue contact point, and It is configured to stretch. A second tissue contact point is then established on the tissue wall, initially at a location proximal to the first tissue contact point or alongside the first tissue contact point. The tissue captured by the tissue grasping assembly is then moved to a position proximal to the second tissue contact point to form a tissue fold and the one or more anchor assemblies are moved across the tissue fold. Can be delivered. Preferably, delivery of the anchor assembly across the tissue fold includes delivery of the anchor assembly across the muscle and serosal layers of the tissue wall.

  Optionally, the third tissue contact point can be set initially at the proximal side of the first tissue contact point or at another location alongside the first tissue contact point. When the tissue captured by the tissue grasping assembly is moved to a position proximal to both the second and third tissue contact points, the tissue folds cause the second and third tissue contact points to be on both sides of the heel. It is formed by positioning. The third tissue contact point can provide dorsal stabilization in delivering the anchor assembly through the tissue fold from the vicinity of the second tissue contact point.

  In a preferred embodiment, the tissue grasping assembly is held in a first flexible tube associated with the distal region of the catheter, and one or more anchor assemblies are associated with the distal region of the catheter. Delivered by an anchor delivery system located inside the two flexible tubes. The tissue grasping assembly includes a pair of jaws configured to move between an open position and a closed position, a plurality of linearly translating barbs, a coil helix, or one or more needles or hooks. It can have any of several mechanisms configured to engage the wall surface. From the tissue engaging position distal to the second tissue contacting point or aligned with the second tissue contacting point to the tissue brazing position, the hinge assembly, treadmill assembly Or by any of several mechanisms such as a linear pull assembly.

  More preferably, the distal region of the catheter positions the first tissue contact point relative to the second tissue contact point such that the tissue fold is disposed substantially perpendicular to the anchor delivery system. It is equipped with a bendable part. In this way, when deployed, the anchor delivery system penetrates the tissue fold and exits into the GI lumen rather than out of the tissue wall, thus reducing the risk of damaging adjacent organs.

  The anchor assembly delivery system of the present invention preferably includes a needle or closure configured to deliver the anchor assembly through the tissue fold. In one preferred embodiment, the anchor assembly has a pair of rod-like anchors that are delivered through the needle in a reduced delivery configuration, and in the reduced delivery configuration, the length of the rod. The axis is substantially parallel to the longitudinal axis of the needle. Once withdrawn from the needle, the rod rotates about 90 ° to engage the tissue. In other embodiments, the anchor assembly can have various shapes of anchors delivered, for example, over the closure.

  In a preferred embodiment of the invention, the catheter is configured to form a plurality of folds of gastrointestinal tissue and these folds can be approximated. Optionally, an anchor assembly can be placed through each fold of tissue, and the multiple folds of tissue can then be brought together by tightening the multiple anchor assemblies together. Alternatively, the anchor assembly can be placed through multiple folds of tissue and the multiple folds of tissue can be approximated by tightening the anchor assembly. As yet another alternative, multiple folds of tissue may be approximated prior to anchor assembly placement. One or more anchor assemblies can then be placed through the multiple folds of the approximated tissue to secure the multiple folds in the approximated position. Multiple folds of tissue can be connected and / or accessed together, for example, to perform surgery such as gastric reduction or treatment of gastroesophageal reflux disease (“GERD”).

  Flexible and reversible stiffening states to facilitate proper positioning and visualization of the tools and instruments of the present invention in a tortuous lumen or treatment site inside an unpredictably supported body structure A shape-fixable guide can be provided. The guide can have an outer tube through which the instrument of the present invention as well as the endoscope can be advanced. As will be described later, typical treatments that can be realized when the tool of the present invention is used in combination with an endoscope include, for example, endoscopic gastric reduction and GERD endoscopic treatment.

  In addition, a method of using the apparatus of the present invention is also presented.

  The above objects and advantages of the present invention, as well as other objects and advantages, will become apparent upon consideration of the following detailed description, taken in conjunction with the accompanying drawings. In the accompanying drawings, like reference numerals designate like parts throughout.

(Detailed description of the invention)
In accordance with the principles of the present invention, methods and devices are provided for forming and securing gastrointestinal ("GI") tissue folds from within the lumen, for example, to reduce the effective cross-sectional area of the GI lumen. These methods and devices can be used to treat obesity by reducing the area for absorption in the stomach or small intestine by bringing the walls of the gastrointestinal lumen closer together and narrowing the lumen. it can. More particularly, the present invention relates to an endoscope that engages a tissue wall of a gastrointestinal lumen, produces one or more tissue folds, and places one or more anchor assemblies through the tissue folds. Related to the device. Preferably, the anchor assembly is placed through the muscle layer and / or serosa layer of the gastrointestinal lumen. In operation, the distal end of the probe engages tissue, and the engaged tissue is then moved to a position proximal to the catheter tip, resulting in a substantially uniform fold of a predetermined size.

  Formation of the tissue fold is preferably accomplished using at least two tissue contact points separated by a distance comprising a straight line or a curve, wherein the separation distance between the tissue contact points is the length of the fold and / or It affects the depth. In operation, the tissue grasping assembly engages a tissue wall in a normal state (ie, is not pleated and is substantially flat) to provide a first tissue contact point. This first tissue contact point is then moved to a position proximal to the second tissue contact point to form a tissue fold. The anchor assembly can then be spread across the tissue fold at a second tissue contact point. Optionally, the third tissue contact point can be set such that the second and third tissue contact points are located on either side of the tissue fold when the fold is formed in the tissue, In spreading the tissue across the tissue fold from the second tissue contact point, backside stabilization can be provided.

  Preferably, the first tissue contact point is used to engage the tissue wall and extend or rotate above the second tissue contact point to form a tissue fold. The tissue fold is then folded into a position where a portion of the tissue fold overlaps the second tissue contact point in an orientation substantially perpendicular to the tissue fold. The anchor is then delivered across the tissue fold at or near the second tissue contact point.

  Referring to FIG. 1, a device 10 of the present invention has a catheter 11 capable of torsional rotation and is interconnected from a distal region 12 of the catheter 11 with first and second flexible tubes 13. And the proximal region 15 of the catheter 11 has a handle 16 and an actuator 17. Catheter 11 is configured to be delivered through the patient's mouth and esophagus to the gastrointestinal lumen. A tissue grasping assembly 18 is disposed at the distal end of the flexible tube 13 and is connected to the actuator 17 via a control wire 19 extending through the flexible tube 13.

  As better shown in FIG. 1B, the flexible tubes 13 and 14 are connected by a hinge assembly 20 having a link 21 that is attached to the flexible tube 13 at a pivot point 22. At the pivot point 23, it is attached to the flexible tube 14. The hinge assembly 20 prevents the tissue grasping assembly 18 from moving beyond a predetermined distance relative to the distal end 24 of the flexible tube 14.

  Still referring to FIG. 1B, flexible tubes 13 and 14 preferably include bendable portions 25 and 26, respectively. The bendable portion may be, for example, a plurality of slots 27 that penetrate the wall surface to increase the flexibility of the tube. Preferably, the flexible tubes 13 and 14 are made of stainless steel and have a slot pattern by etching or laser cutting. More preferably, the slot pattern is a sinusoidal repeating pattern composed of slots orthogonal to the longitudinal axes of the tubes 13 and 14. Other flexible patterns will be apparent to those skilled in the art.

  Referring to FIGS. 2A and 2B, the tissue grasping assembly 18 is arranged to rotate the pair of jaws 28a, 28b about the pivot point 29 between an open state (FIG. 2A) and a closed state (FIG. 2B). Have. A control wire 19 is connected to the arms 31 a and 31 b via a pivot point 30. Arms 31a and 31b are then pivotally connected to jaws 28a and 28b at pivot points 32a and 32b, respectively. Each of the jaws 28a and 28b preferably includes a pointed tooth 33 disposed at the distal end so that the tissue wall of the GI lumen can be easily grasped.

  A control wire 19 is connected to the actuator 17 of the handle 16 so that translation of the wire within the flexible tube 13 opens and closes the jaws. Specifically, driving the control wire in the distal direction (as indicated by arrow A in FIG. 2A) moves the pivot point 30 in the distal direction and opens the jaws. Driving the control wire 19 in the proximal direction (as indicated by arrow B in FIG. 2B) moves the pivot point 30 in the proximal direction, closing the jaws together. In other embodiments, the tissue grasping assembly 18 may comprise a grasping hook or fork, or a plurality of needles, connected to the distal end of the flexible tube 13.

  The flexible tube 14 is fixed and immobile in the catheter 11, while the flexible tube 13 is connected to the catheter 11 only by the hinge 20. Thus, when the control wire 19 is extended in the distal direction, the flexible tube 13 is carried in the distal direction. When the control wire 19 is retracted in the proximal direction, the flexible tube remains stationary until the jaws 28a and 28b are closed, after which the control wire 19 is further retracted by moving the actuator 17. The flexible tube 13 bends in the bendable region 25 as described later.

  Referring now to FIGS. 1 and 3A-3E, the operation of device 10 will be described to create a tissue fold on the tissue wall of the GI lumen. In FIG. 3A, the distal region 12 of the catheter 11 has been placed through the esophagus into the patient's GI lumen, and the jaws 28a and 28b of the tissue grasping assembly 18 have moved the actuator 17 to the most distal position of the handle 16. It is opened by moving. 3B, the actuator 17 can then be moved proximally until the jaws of the tissue grasping assembly 18 engage a portion of the tissue wall W at the contact point P1.

  Referring to FIG. 3C, after engaging the tissue wall at the contact point P1, the flexible tube 13 is driven proximally through the catheter 11 by pulling the control wire 19 further proximally, The tissue wall W is stretched to generate a tissue fold F. During movement of the flexible tube 13, the link 21 of the hinge assembly 20 moves the tissue grasping assembly 18 from a position distal to the distal end 24 of the flexible tube 14. To a position proximal to the distal end 24 thereof. The bendable portions 25 and 26 of the flexible sleeves 13 and 14 respectively allow any lateral movement caused by the movement of the hinge assembly 20. Advantageously, the formation of folds F facilitates penetration of the needle into the tissue wall and subsequent delivery of the anchor assembly, as described below.

  Referring to FIG. 3D, moving the actuator 17 further proximally causes the flexible tubes 13 and 14 to bend at the bendable portions 25 and 26. The hinge assembly 20 transmits the force applied to the flexible tube 13 via the control wire 19 and the actuator 17 to the distal end 24. Preferably, the flexible tube 14 is designed so that the distal end 24 contacts the tissue fold F at a contact point P2 and is substantially perpendicular to the tissue fold F. As shown in FIG. 3E, once the tissue fold F is stretched across the distal end 24 of the flexible tube 14, the pointed needle or closure 34 is placed over the four layers of the tissue wall W. It can extend from the distal end 24 of the flexible tube 14 to penetrate everything. A sharp needle or closure 34 is delivered to the flexible tube 14 via the inlet 35 of the handle 16 (see FIG. 1A).

  As already mentioned, the GI lumen has an inner mucosal layer, connective tissue, muscle layer, and serosa layer. In order to obtain a durable grip, for example in performing gastric reduction surgery, a staple or anchor used to achieve GI lumen reduction must engage at least the muscle tissue layer. More preferably, it must also engage the serosa layer. Conveniently, by stretching the tissue fold F across the distal end 24, the anchor can be pierced through both the muscular and serosal layers, allowing for durable gastrointestinal tissue proximity. Become.

  After the tissue fold F is stretched across the distal end 24 of the flexible tube 14 to form a contact point P2 with the tissue wall W, as shown in FIG. Can extend from the distal end 24 through the tissue fold F. Because the needle 34 penetrates the tissue wall twice, the needle 34 will exit into the gastrointestinal lumen, thus reducing the possibility of damage to surrounding organs. Once the needle has penetrated the tissue fold F, the anchor assembly is driven through the distal end 24 as described below.

  4A-4C, a first embodiment of an anchor assembly suitable for use in the apparatus of the present invention is described. The anchor assembly 36 has a T-shaped anchor assembly having a distal rod 38 a and a proximal rod 38 b connected by a suture 39. The exact shape, dimensions, and materials of the anchor may vary for individual applications. Furthermore, the suture material may also vary for individual applications. For example, the suture material can be comprised of a single filament wire, a multifilament wire, or any other conventional suture material. Alternatively, the suture 39 may include an elastic material such as a rubber band so that the distance between the proximal rod and the distal rod can be easily adjusted. The suture thread 39 extends through a pair of through holes 40 of each rod to form a loop. Alternatively, the suture 39 can be attached to the rod via an eyelet, or can be attached to the rod using a suitable adhesive. Preferably, the through hole 40 is located near the center of the rods 38a and 38b.

  Referring to FIG. 4B, rods 38a and 38b can be delivered through needle 34 (see FIG. 3E) using push bar 42. The push bar 42 is configured to translate freely through the flexible tube 14 and the needle 34. The push bar 42 is preferably flexible so that it can slide through the bendable portion 26 of the flexible tube 14. In addition, push bar 42 may include a notch 43 near the distal end to facilitate retention and pulling of suture 39 after anchor delivery.

  Upon delivery of the anchor, the longitudinal axis of the distal rod 38a is substantially parallel to the longitudinal axis of the needle 34. However, once the distal rod 38a is pushed out of the needle 34, the tension of the suture causes the rod to rotate about 90 degrees about the longitudinal axis so that the longitudinal axis of the rod is substantially aligned with the longitudinal axis of the needle 35. Become orthogonal. This rotation of the distal rod 38a prevents the distal rod 38a from being pulled back through the wall W of the tissue.

  Referring to FIG. 4C, once rod 38a is pushed distal to heel F, needle 35 is retracted and push bar 42 is used to push rod 38b proximal to fold F of tissue. The Once the proximal rod 38b is pushed out of the needle, similar to the distal rod 38a, the suture tension causes the proximal rod 38b to rotate about 90 °. The notch 43 of the push bar 42 can then be used to tighten the suture 39 by any of a variety of mechanisms. Alternatively, the suture 39 may include an elastic material that dynamically clamps the rod against the tissue fold F.

  Referring now to FIG. 5A, an anchor assembly according to another embodiment has a T-shaped anchor assembly suitable for placement on the closure 50. More particularly, the distal rod 38a includes a through hole 51 sized to pass the closure tip 52, and the closure 50 is routed through the inlet 35 of the handle 16 (see FIG. 1A). And is inserted through the flexible tube 14 in a translatable manner. The proximal rod 38b may be a solid rod without a through hole through which the closure 50 passes. Alternatively, the proximal rod 38b may have a through hole through which the closure is passed. Preferably, the closure tip 52 is pointed so that it can easily penetrate tissue.

  With reference to FIG. 5B, once the rod 38a is pushed distally to the heel F, it rotates into a position that is substantially parallel to the tissue wall W and perpendicular to the longitudinal axis of the closure. . The closure 50 is then retracted and the proximal rod 38b is pushed out of the flexible tube 14. More particularly, when the flexible tube 14 is withdrawn from the tissue wall W, the proximal rod 38b is withdrawn through the distal end 24. When exiting the flexible tube 14, the proximal rod 38 b then rotates substantially 90 ° and is pressed against the tissue wall W.

  Referring to FIG. 6A, an anchor assembly 55 according to a further embodiment has a T-shaped anchor assembly similar to the embodiment shown in FIG. 4A. However, anchor assembly 55 includes a fine wire rope 56 that can be twisted together to maintain the tension between rods 38a and 38b.

  With reference to FIG. 6B, a method of delivering the anchor assembly 55 will be described. Initially, distal rod 38a is delivered across both walls of the tissue using needle 34. The needle is then retracted to release the distal rod 38a, and the distal rod 38a engages the tissue wall. The needle 34 is then retracted to release the proximal rod 38b, and the proximal rod 38b rotates to engage the tissue wall. The proximal portion of the wire rope is captured by a notch 43 (see FIG. 4B) of the push rod 42, and rotating the push rod tightens the proximal rod 38b to the tissue fold. Since the wire rope 56 is twisted by the rotation of the push rod 42, a desired force can be maintained against the wall surface of the tissue.

  Referring now to FIG. 7, there is shown an anchor assembly that is suitable for use with the apparatus of the present invention and is adjustable in one direction. Anchor assembly 60 has a distal anchor 62 and a proximal anchor 64 that is adjustable in one direction, connected by a suture 39. The distal anchor 62 is fixed with respect to the suture 39 with respect to translation. Such fixation can be achieved in various ways. For example, as seen in FIG. 7A, the distal anchor 62 can include a pair of through holes 63 disposed near the center of the anchor 62, through which the suture 39 is passed, and the knot Can be tied at 65.

  FIG. 7B presents another technique for securing the distal anchor. As seen in FIG. 7B (i), the distal anchor 62 can include a hollow tube T having an opening O. The distal end of the suture 39 is threaded through the opening O and formed into a knot K dimensioned so that it cannot pass through the opening O, and the distal anchor is secured to the suture. To facilitate the formation of the knot K, the distal anchor 62 may optionally have a distal opening DO dimensioned to allow the knot K to pass through. The distal end of the suture 39 can be passed through the distal opening DO to form a knot and then pulled back into the hollow tube T of the anchor 62 until it is captured by the opening O.

  A disadvantage of the fixation technique described with respect to FIG. 7B (i) is that the suture 39 can be torn or severed by rubbing against the opening O. In FIG. 7B (ii), the hollow tube T has a first end E, and a wire ring L that can be formed from, for example, a nickel-titanium alloy (“Nitinol”) is connected to the first end E. Yes. A suture 39 is threaded through the wire ring before terminating the knot K. The knot K is dimensioned so that it cannot be pulled back through the wire ring. The wire ring L guides the suture thread 39 passing through the opening O, reduces the rubbing of the suture with respect to the opening, and reduces the risk of tearing or cutting the suture thread 39.

  FIG. 7B (iii) presents yet another alternative technique for securing the distal anchor to the suture. The distal anchor 62 also has a hollow tube T with an opening O. The rod R is disposed inside the tube T, and both ends of the tube may be closed or crimped to the rod R in order to hold the rod inside the tube. The distal end of the suture 39 is passed through the opening O, passed around the rod R, and returned out of the opening O. A suture is then tied at the knot K to secure the distal anchor 62 to the suture 39.

  In addition to the technique shown in FIGS. 7A and 7B, the suture 39 can alternatively be secured to the anchor 62 by other means, such as binding to an eyelet or a suitable adhesive. Additional techniques will be apparent to those skilled in the art. Although the anchor 62 is illustrated as a rod-shaped or T-shaped anchor, any of a variety of anchors known per se can be used as the distal anchor 62. A typical anchor is described in US patent application Ser. No. 10 / 612,170, filed Jul. 1, 2003, co-pending with this application, which is hereby incorporated by reference herein in its entirety. It shall be incorporated in the specification. Additional anchors are described below with respect to FIG. For purposes of the present invention, anchors and anchor assemblies should be understood to include clips for securing tissue, and knots and knot substitutes. In addition, the anchor assembly can include a plurality of components that are not initially connected to each other, and these components can be collected and / or connected to a treatment site within the patient's body.

  Referring again to FIG. 7A, the adjustable proximal anchor 64 has an outer cylinder 66 having a first end 67a and a second end 67b, and a first opening 68a and a second opening 68b. is doing. The first and second openings 68 are preferably located about 180 ° apart near the center of the cylinder 66. Further, the anchor 64 has the first flexible rod 70 a and the second flexible rod 70 b both disposed inside the outer cylinder 66 and connected to the first and second ends 67 of the cylinder 66. Have. The rods 70 can be formed from, for example, nitinol or a polymer and can be separated from each other by a small gap G. As with the previous anchor assembly, the exact shape, dimensions, and materials of the anchor and suture may vary depending on the needs of a particular application.

  As best seen in FIG. 7C, the suture 39 passes from the distal anchor 62, through the first opening 68a of the proximal anchor 64, around the second flexible rod 70b, and through the first flexible rod 70b. Circulates through the sex rod 70a, passes between the rods 70a and 70b, and passes through the second opening 68b. This suture routing provides a one-way adjustment capability that can reduce the length L of the suture 39 located between the distal anchor 62 and the proximal anchor 64. On the other hand, the routing of the suture makes it impossible to increase the length L. FIG. 8 illustrates this unidirectional adjustment capability mechanism in more detail. Optionally, the suture 39 may be tied with a knot 69 on the proximal side of the anchor 64, thereby forming a proximal loop of suture and facilitating placement and / or adjustment of the anchor assembly 60. be able to.

In FIG. 8A, a proximally directed force F ₁ is applied to the suture 39 proximally of the adjustable anchor 64 while the anchor 64 is held stationary or distally. It is advanced. Some of the force _{F 1} is transmitted through the suture 39 to the second flexible rod 70b, produce bending the rod 70b. This increases the gap G, allowing the suture 39 to freely pass between the rods 70a and 70b and the proximal anchor 64, facilitating unidirectional adjustment. If the suture 39 is pulled proximally while keeping the anchor 64 stationary, the distal anchor 62 is pulled proximally toward the anchor 64. On the other hand, when retracting the suture 39 in the proximal direction while advancing the anchor 64 in the distal direction, the distal anchor 62 does not move depending on the degree of movement of the proximal anchor 64 in the distal direction. Stays or is pulled proximally toward the proximal anchor 64. In any case, the length L of the suture 39 disposed between the anchors 62 and 64 is shortened, and the length between the anchors is adjusted only in one direction.

In FIG. 8B, a distally directed force F ₂ is applied to the suture 39 distal to the adjustable anchor 64. Force F _2, for example by tissue being compressed between the anchor 62 and 64, there is a possibility that applied. The compressed tissue stores energy in a manner similar to a compression spring and attempts to push the anchors 62 and 64 apart after tightening in one direction. The force F ₂ causes the loop of suture 39 around the first and second rods 70 to be tightened so that the suture 39 is locked between the first and second flexible rods 70 by friction. The gap G is closed by bending both rods inward. In this manner, the suture length L between the anchors 62 and 64 can be selectively shortened, but not increased.

  As will be apparent to those skilled in the art, the amount of force required to adjust the length L in one direction can be varied in various ways. For example, the length, flexibility, or diameter of the rod 70 can be changed. Similarly, the elasticity or diameter of the suture 39 may be changed. The initial gap G may be increased or decreased. Still further, the material used to form the rod 70 and suture 39 can be altered to change material properties such as coefficient of friction, and / or a lubricious coating can be applied to the rod 70 or suture 39. You may prepare. Additional methods for changing the magnitude of the force, some of which are described below with respect to FIG. 9, are apparent in light of the disclosure herein and are encompassed by the present invention.

  Referring now to FIG. 9, another anchor 64 is shown. In FIG. 9A, the flexible rod 70 of the adjustable anchor 64 'has been rotated relative to the opening 68 (and vice versa). When using the suture routing shown in FIGS. 7 and 8, the friction when the force is applied to the anchors 62 and 64 is gradually increased by rotating the rod 70 clockwise up to 180 °. When force is applied in the manner described with reference to FIG. 8B, the strength of locking due to friction increases. However, friction is also increased when adjusting the length of the suture between the proximal and distal anchors in one direction by applying a force in the manner described with respect to FIG. 8A. When the rod 70 is rotated clockwise beyond 180 °, the anchor 64 ′ is frictionally locked regardless of which direction of force is applied to the suture 39, thus eliminating the ability to adjust in one direction. . When the rod 70 is rotated counterclockwise with respect to the opening 68, the friction is initially reduced no matter which direction force is applied to the suture 39. When it is rotated counterclockwise beyond about 90 °, the frictional locking described with reference to FIG. 8B is eliminated, and adjustment in both directions is expected. Continuing counterclockwise rotation beyond about 450 ° will reverse the direction of frictional locking and unidirectional adjustment, and counterclockwise rotation above about 720 ° is applied to the suture 39. Regardless of the direction of force, it provides frictional locking.

As already mentioned, the openings 68 in the cylinder 66 of the anchor 64 are preferably arranged 180 ° apart from each other. However, in order to increase the locking force due to friction without greatly increasing the friction during unidirectional adjustment, the first opening 68a can be seen as the second opening 68b as seen in the anchor 64 '' of FIG. 9B. May be rotated counterclockwise (or vice versa). In this manner, the first opening 68a is no longer aligned with the rod 70, while the second opening 68b is still aligned with the rod 70. When a force F ₁ is applied to the anchor 64 '', the second flexible rod 70b is able to flex outwardly, gap G is increased, thereby it is facilitated unidirectional adjustment. Similarly, when the force F ₂ applied to the anchor, gap G is more densely closed to suture 39, the force of the locking due to friction increases. On the other hand, if the first opening 68a is rotated in the clockwise direction with respect to the second opening, the locking force due to friction is expected to be small.

  In FIG. 9C, the proximal adjustable anchor 64 '' 'has another suture routing. A suture 39 passes from the distal anchor 62 through the first opening 68a of the anchor 64 '' ', around the second flexible rod 70b, and around the first flexible rod 70a. , Returns to the periphery of the second flexible rod 70b, passes between the rods 70a and 70b, and passes out of the second opening 68b. Similar to the suture routing described with respect to the anchor 64 of FIGS. 7 and 8, the suture routing shown in FIG. 9C is similar to that of the suture 39 positioned between the distal anchor 62 and the proximal anchor 64 ′ ″. It provides a one-way adjustment capability that allows the length L to be shortened. On the other hand, the routing of the suture makes it impossible to increase the length L. Other suture routings that can be adjusted in one direction will be apparent to those skilled in the art.

  Referring to FIG. 10, another one-way adjustable anchor having three rods is shown. Anchor assembly 80 has a distal anchor 62 and a proximal anchor 82. A proximal anchor 82 that is adjustable in one direction includes an outer cylinder having a first end 85a and a second end 85b (not shown), and a first opening 86a and a second opening 86b. 84. The first and second openings 86 are preferably located about 180 ° apart near the center of the cylinder 84. In addition, the anchor 82 has the first flexible rod 88a, the second flexible rod 88b, and the third flexible rod 88c all disposed within the outer cylinder 66, and the first and second It is connected to the second end portion 85. The rods 88 are separated from each other by gaps G1 and G2.

The suture 39 passes from the distal anchor 62 through the first opening 86a of the proximal anchor 82, around the first rod 88a, between the first rod 88a and the second rod 88b, Between the second rod 88b and the third rod 88c, around the third rod 88c, back to the first rod 88a, around the first rod 88a, and outside the second opening 86b. Has passed. As seen in FIG. 10A, when force F ₁ is applied to suture 39, gaps G1 and G2 remain open and are positioned between one-way adjustment / distal anchor 62 and proximal anchor 82. It is easy to shorten the length L of the suture thread 39 to be performed. As seen in FIG. 10B, when a force F ₂ is applied to the suture 39, gaps G1 and G2 are closed towards the suture 39, to form a locking by friction, the length of the suture 39 L Make it impossible to increase.

  Referring to FIG. 11, another three rod anchor assembly is shown. All of the one-way adjustable anchors described above with respect to FIGS. 7-10 have a rod positioned inside a cylinder having an opening for threading the suture. The opening functions to position the suture in the center of the rod and can be used to change the amount of force applied during adjustment and frictional locking, as already described. However, such openings present the risk of tearing or cutting the suture as the suture slides through the opening.

  As seen in FIG. 11, anchor assembly 90 includes a distal anchor 62 and a proximal anchor 92. A proximal anchor 92 that is adjustable in one direction includes a first flexible rod 94a and a second flexible rod 94b, and a rigid rod 96 that is preferably larger in diameter than the first and second rods 94. have. The flexible rod 94 is preferably made from nitinol or polymer, while the rigid rod 96 is preferably made from stainless steel or polymer. Other materials will be apparent to those skilled in the art.

  Further, the anchor 92 has a first outer cylinder 98 a and a second outer cylinder 98 b crimped to the ends of the first and second rods 94 and the rigid rod 96. Instead of crimping, the first and second cylinders 98 may each have an end cap (not shown) to which the rod is connected. The first and second cylinders 94 do not extend to the central portion of the anchor 92. The flexible rods 94 are separated from each other by the gap G1, while being separated from the rigid rod 96 by the gap G2.

  Anchor 92 has three rods, but unlike anchor 82 in FIG. 10, suture 39 is wrapped only around two of them to achieve unidirectional adjustment. . As seen in FIGS. 11B and 11C, the suture routing shown for anchor assembly 90 is similar to the routing previously described with respect to anchor assembly 60 of FIGS. As seen in FIG. 11A, the break between the first and second cylinders 98 functions to position the suture 39 to the center of the rod, while the rigid rod 96 flexes the suture 39. The anchor 92 is reinforced when it is guided around the sex rod 94, and the rotation of the anchor 92 is reduced.

The suture 39 passes from the distal anchor 62 to the proximal anchor 92, between the rigid rod 96 and the flexible rod 94, around the second flexible rod 94b, and the first flexible rod 94a. , Passes between the rigid rod 96 and the first flexible rod 94a, passes between the flexible rods 94a and 94b, and passes out. As seen in FIG. 11A, when force F ₁ is applied to the suture 39, the flexible rod 94 is pulled apart to widen the gap G1, while the gap G2 remains substantially constant and the distal anchor is The length L of the suture 39 located between 62 and the proximal anchor 92 can be adjusted in one direction. As seen in FIG. 11B, when the force F ₂ is applied to the suture 39, the gap G1 is closed towards the suture 39, the engagement is formed by friction, an increase in the length L of the suture 39 Make it impossible. The gap G2 still remains substantially constant.

  Referring to FIG. 12, another one-way adjustable anchor assembly having a pivot point is shown. Anchor assembly 100 has a distal anchor 62 and a proximal anchor 102. A unidirectional adjustable proximal anchor 102 is an outer cylinder having a first end 104a and a second end 104b (not shown) and a first opening 105a and a second opening 105b. 103. The first and second openings 105 are preferably arranged about 180 ° apart near the center of the cylinder 103. Further, the anchor 102 has the first rod or paddle 106 a and the second rod or paddle 106 b arranged inside the outer cylinder 103, and the first and second cylinders 103 are arranged by pins 107 passing through the pivot holes 108. 2 connected to the end. In this manner, the first and second paddles 106 can rotate about the pivot hole 108. The paddles 106 can be formed from stainless steel or polymer, for example, and are separated from each other by a gap G. As with the previous anchor assembly, the exact shape, size, and material of the anchor and suture 39 may vary depending on the needs of a particular application.

As an example, the suture 39 passes from the distal anchor 62 through the first opening 105a of the proximal anchor 102, around the second paddle 106b, around the first paddle 106a, and between the paddles 106a and 106b. However, it passes outside through the second opening 105b. By providing a pivot support hole 108, when a force F ₁ is applied as described above, it ensures the paddle 106 rotates away from each other gap G is spread, allowing unidirectional regulation . Similarly, when the force F ₂ described above is applied, the paddle 106 rotates so as to be combined, the gap G is closed, the suture 39 is sandwiched between the paddles, and is locked by friction. Increasing the magnitude of the force F ₂ serves to rotate the paddle 106 further tightly, and thus serves to increase the strength of the frictional lock acting on the suture 39 between the paddles. In this way, unidirectional adjustment is achieved.

  Referring now to FIG. 13, another one-way adjustable anchor assembly having a spring material is shown. Anchor assembly 110 has a distal anchor 62 and a proximal anchor 112. A proximal anchor 112 that is adjustable in one direction is an outer cylinder having a first end 114a and a second end 114b (not shown), and a first opening 115a and a second opening 115b. 113. The first and second openings 115 are preferably arranged near the center of the cylinder 113 and separated by about 180 °. Further, the anchor 112 has the first rod 116 a and the second rod 116 b separated by the gap G, and the spring material 118 all disposed inside the outer cylinder 113. The spring material 118 abuts against the rod 116, which is preferably substantially the same length as the cylinder 113 and can move freely within the cylinder 113 or the end of the cylinder 113 ( (Not shown). The spring material 118 may also be freely movable within the cylinder 113 or may be connected to the cylinder and has a lumen 119 that is preferably less than or equal to the diameter of the suture 39. . The spring material 118 can be composed of, for example, a compressible biocompatible foam and functions as a compression spring.

The suture 39 passes from the distal anchor 62 to the proximal anchor 112 through the first opening 115a of the cylinder 113, between the rods 116, through the lumen 119 of the spring material 118, and the second It passes through the opening 115b. Lumen 119, in contact snugly suture 39, therefore the friction is generated between the suture and the spring material by the force F ₁ is applied, pressed spring material towards the wall surface 114 of the cylindrical This reduces the pressure applied to the rod 116 by the spring material 118, increases the gap G, and the length L of the suture 39 located between the distal anchor 62 and the proximal anchor 102. One-way adjustment can be continued. The force F ₂ is applied to stretch the spring material 118 against the rod 116, thereby increasing the pressure being applied to the rod by the spring material, closing the gap G and causing the suture 39 to friction between the rods 116. It is locked by.

  Referring to FIG. 14, another one-way adjustable anchor assembly having a one-way valve is shown. In FIG. 14A, the anchor assembly 120 has a distal anchor 62 and a proximal anchor 122. The unidirectional adjustable proximal anchor 122 has an outer cylinder 124 having first and second ends 125a and 125b and a first opening 126a and a second opening 126b. The first and second openings 126 are preferably located about 180 ° apart near the center of the cylinder 124. Further, the anchor 122 has a first inclined surface 128a and a second inclined surface 128b pressed by compression springs 129a and 129b, whereby a one-way valve V is formed at the contact point of the two inclined surfaces. ing. The inclined surface 128 and the spring 129 are disposed inside the outer cylinder 124, and the spring 129 contacts the end 125 of the cylinder 124 and the end of the inclined surface. The suture 39 'has a plurality of knots or beads B configured to operate the one-way valve V.

The suture 39 'passes from the distal anchor 62 to the proximal anchor 122 through the first opening 126a of the cylinder 124, through the inclined surface 128, through the one-way valve V, and into the second opening. 126b is passed to the outside. When a force F ₁ is applied to the suture thread 39 ′, the bead B comes into contact with the inclined surface 128 and gently pulls them apart by the action of the compression spring 129, opening the valve V and allowing the bead to pass through the valve. Once the bead has passed through the valve V, the spring 129 pushes the ramp 128 back into the juxtaposed position and closes the valve. Continuing to apply force F ₁ allows multiple beads to pass through the valve and easily adjusts the length L of the suture located between the distal anchor 62 and the proximal anchor 122 in one direction. Can do. When the force F ₂ is applied, the bead B of the suture 39 ′ collides with the proximal side of the inclined surface 128. However, the force transmitted by the bead to the ramp is perpendicular to the direction required to compress the spring 129 and pull the ramp 128 away. Therefore, even if the bead B hits the proximal side of the inclined surface 128, the one-way valve V cannot be opened and therefore cannot be returned through the valve in the distal direction. This ensures only adjustment of the length L of the suture located between the distal anchor and the proximal anchor in only one direction, i.e. shortening of the length L.

  Referring to FIG. 14B, another one-way adjustable anchor with a one-way valve is shown. Anchor assembly 130 has a distal anchor 62 and a proximal anchor 132. The proximal anchor 132, which can be adjusted in one direction, has a lumen 134 in which an inclined surface 136 forming a one-way valve V is disposed in a cantilever manner. A “zipper cord” fastener 138 having a plurality of inclined surfaces 139 connects the proximal anchor 132 and the distal anchor 62. The plurality of inclined surfaces 139 are arranged with a phase shifted by about 180 ° with respect to the inclined surface 136 of the anchor 132.

The fastener 138 passes through the lumen 134 from the distal anchor 62 to the proximal anchor 132 and passes by the beveled surface 136. If the force F ₁ is applied to the fastener to cause the inclined surface 139 of the fastener 138 to mesh with the inclined surface 136 to bend the inclined surface 136 or to deform the inclined surface 136 in a cantilever manner, the fastener The inclined surface 139 of 138 can pass through the one-way valve V in the proximal direction, and the length L of the fastener 138 located between the proximal anchor and the distal anchor can be adjusted in one direction. it can. Conversely, when a force F ₂ is applied to the fastener, the proximal side of the ramped surface 136 of the anchor 132 abuts the distal side of the ramped surface 139 of the fastener 138 so that the fastener is disengaged through the proximal anchor 132. The length L of the fastener located between the anchors cannot be greatly increased.

  Referring to FIG. 15, three other one-way adjustable anchor assemblies having a knot are shown. In FIG. 15A, anchor assembly 140 has a distal anchor 142 and a proximal anchor 144. Through holes 143a and 143b extend through distal anchor 142, while through holes 145a and 145b extend through proximal anchor 145. Preferably, through holes 143 and 145 are located near the centers of anchors 142 and 144, respectively.

  The distal end of suture 39 passes through through hole 145a of proximal anchor 144 to distal anchor 142, passes through through hole 143a at distal anchor 142, and returns through through hole 143b. Further, the distal end of the suture 39 returns from the distal anchor 142 to the proximal anchor 144 and passes through the proximal anchor through-hole 145b. The distal end of the suture thread 39 is tied to a one-way knot S located on the proximal side of the anchor 144. FIG. 15B is a detailed view illustrating the formation of the knot S.

As will be apparent to those skilled in the art, the application of force F ₁ causes the suture 39 to slide through the through holes 143 and 145 and reduces the length L of the suture 39 located between the anchors 142 and 144. The suture thread 39 can easily pass through the tying S in the proximal direction, facilitating adjustment in one direction of the length L. On the other hand, when the force F ₂ exerted, is tightening a slip knot S, suture 39 is so can not pass through the slip knot S to the distal direction, it precludes the increase of length L.

  FIG. 15C shows another embodiment of the anchor assembly 140, where the tie is located inside the proximal anchor. Anchor assembly 140 'has a distal anchor 142 and a proximal anchor 144'. Proximal anchor 144 ′ has a hollow cylinder or tube 146 with distal openings 147 a and 147 b and a proximal opening 148.

  The distal end of suture 39 passes through proximal opening 148 into the interior of tube 146. It then passes through the distal opening 147a of the proximal anchor 144 'to the distal anchor 142, through the through hole 143a at the distal anchor 142, and back through the through hole 143b. The suture 39 then returns from the distal anchor 142 to the proximal anchor 144 'and passes through the distal opening 147b into the proximal anchor tube 146. The distal end of the suture 39 is tied to a one-way knot S located inside the tube 146 of the anchor 144 '. Anchor 140 'can be adjusted in one direction in a manner similar to that described above with respect to anchor assembly 140 of FIG. 15A.

  7-15 illustrate an anchor assembly having various mechanisms for achieving unidirectional adjustment of the distance between the proximal anchor and the distal anchor. These mechanisms are presented for the purpose of clarity only and should not be construed as limiting the invention in any way. Additional mechanisms for achieving unidirectional adjustment will be apparent to those skilled in the art in light of the disclosure herein and are encompassed by the present invention. Also, most of the anchor assemblies of FIGS. 7-15 are described as having a distal anchor secured to the suture and a proximal anchor adjustable. However, the distal anchor may instead be adjustable and the proximal anchor may be fixed and / or both anchors may be adjusted in one direction, such as the anchor assembly 140 of FIG. Should be understood.

  Referring now to FIG. 16, a bi-directional adjustable anchor assembly having a locking mechanism is illustrated. Anchor assembly 150 has a distal anchor 62 and a proximal anchor 152. As seen in FIG. 16A, a bi-directionally adjustable proximal anchor 152 has an outer side having a first end 154a and a second end 154b, and a first opening 155a and a second opening 155b. A cylinder 153 is included. The first and second openings 155 are preferably located about 90 ° apart near the center of the cylinder 153. Further, the proximal anchor 152 has a tension spring 158 disposed inside the outer cylinder 153.

As seen in FIG. 16B, the suture 39 passes from the distal anchor 62 to the proximal anchor 152 through the first opening 155a, around the spring 158, and out through the second opening 155b. Yes. The suture 39 is free to move in either direction around the tension spring 158 when the force F ₁ or force F ₂ is applied, and the suture located between the proximal anchor and the distal anchor. Bi-directional adjustment of the length L is facilitated. On the other hand, as can be seen in FIG. 16C, when forces F ₁ and F ₂ are applied at a sufficient magnitude at the same time, the suture 39 will spread the line T of the spring 158 and will be trapped between the lines T and become To prevent further adjustment of the suture length L.

The amount of force required to actuate the locking mechanism of the proximal anchor 152 to lock the suture 39 within the line T of the spring 158 can be specified / changed in various ways. . For example, the angular spacing of the opening 155 around the outer cylinder 153 can be varied, the spring constant of the spring 158 can be specified, and / or the spring 158 or suture 39 can be provided with a lubricious coating. it can. Other techniques will be apparent to those skilled in the art. The simultaneous application of forces F ₁ and F ₂ is encountered when the anchor assembly 150 is placed across the tissue fold and the suture length L is adjusted to compress the tissue fold. is expected. At that time, the practitioner of the compressed tissue will apply force F ₂ while the health care worker applies force F ₁ .

  The anchor assembly of FIGS. 10-16 is illustrated by way of example with a suture or fastener knot or ring disposed on the proximal side of the proximal anchor (eg, the knot of suture 39 of anchor assembly 60 of FIGS. 7 and 8). However, it should be understood that such rings or knots may optionally be provided to facilitate placement and / or adjustment of the anchor assembly. is there. Further, the anchor assembly described above has, by way of example, a distal rod or T-shaped anchor. However, it should be understood that the distal T-anchor is presented only for ease of explanation. Various distal anchors (and proximal anchors) are known per se, such as surgical or endoluminal clips, clips for securing tissue, and suture knots or knot substitutes. Any anchor may be included. A typical anchor is described in US patent application Ser. No. 10 / 612,170, filed Jul. 1, 2003, co-pending with this application, which is hereby incorporated by reference herein in its entirety. It shall be incorporated in the specification. In addition, the anchor assembly can include a plurality of components that are not initially connected to each other, and these components can be collected and / or connected to a treatment site within the patient's body. Further anchors are described below with respect to FIG.

  Referring to FIG. 17A, the joint anchor 160 has a semi-cylindrical base 161, a rod 162, and a suture 39. The rod 162 rotates about a pivot point 163 between an extended position (shown in FIG. 7A) and a reduced shape position (the rod 162 pivots into the semi-cylindrical base 161). (As indicated by arrow 164). The joint anchor 160 can be delivered through the tissue fold, for example, using the needle 34 described above with respect to FIG. 3E. Preferably, the joint anchor 160 is biased to the extended position and automatically expands when pushed out of the needle.

  With reference to FIGS. 17B and 17C, the anchors of the present invention may further have one or more stretched bodies connected by at least one suture. In FIG. 17B, the anchor 165 has an oval ring 166, and sutures 39 are attached to approximately opposite sides of the ring. In FIG. 17C, the anchor 168 has a chevron bracket 169 having a pair of through holes 170 for the suture 39. In FIG. 17D, the anchor 171 has an elongated bead 172 having a pair of through holes 173 for the suture 39. These three anchors 165, 168, and 171 (and the previously described T-anchor) all have a first dimension (eg, width) that is substantially greater than the second dimension (eg, height). is doing. Because of this dimensional difference, anchors 165, 168, and 171 need to be inserted into the needle (eg, needle 34 in FIG. 3E) in a specific orientation. Once the anchor is pushed through the tissue wall, the tension applied to the suture 39 rotates the anchor so that it cannot be pulled back through the tissue wall. Many other anchors can be used without departing from the scope of the present invention, as will be appreciated by those skilled in the art.

  Referring now to FIG. 18A, another embodiment of an apparatus for forming tissue folds constructed according to the principles of the present invention is described. The device 175 has a treadmill assembly 176 disposed at the distal end 174 of the flexible tube 177. The flexible tube 177 is configured to be inserted through the patient's mouth and esophagus into the stomach. The treadmill assembly 176 includes a conveyor 180 that rotates around a pair of hubs 181a and 181b. Hubs 181a and 181b rotate about shafts 182a and 182b, respectively, and are connected to each other by bracket 183. A plurality of barbs or needles 185 are arranged at substantially regular intervals around the entire circumference of the conveyor 180.

  The flexible tube 177 preferably includes a plurality of slots 186 that penetrate the wall surface to improve the flexibility of the tube while allowing torsional rotation. Preferably, the flexible tube 177 is made of stainless steel and has a slot pattern by etching or laser cutting. Preferably, the slot pattern is a sinusoidal repeating pattern composed of slots orthogonal to the longitudinal axis of the tube. Additional patterns and / or other patterns will be apparent to those skilled in the art.

  18 and 19, the transmission of power to the treadmill assembly 176 is illustrated. Specifically, a drive shaft 202 located inside the flexible tube 177 is connected to a manual knob or motor located at the proximal end of the catheter. A bevel gear 203 is provided at the distal end of the drive shaft 202 and meshes with a bevel gear 204 provided on the shaft 182b. Therefore, the rotation of the bevel gear 203 is transmitted to the bevel gear 204 to rotate the shaft 182b. Next, the shaft 182b rotates the hub 181b to operate the conveyor 180. When the rotation of the drive shaft 202 is reversed, the direction of the conveyor 180 is reversed.

  Referring again to FIGS. 18A-18D, a method of forming a gastrointestinal tissue fold F using the device 175 will be described. In FIG. 18A, a flexible tube 177 is positioned such that the treadmill assembly 176 contacts the tissue wall W through the esophagus. Preferably, the contact should be made at an angle to the tissue wall W. For example, although an angle of about 45 ° is shown in FIG. 8A, many other angles can be used without departing from the scope of the present invention.

  When the treadmill assembly 176 contacts the tissue wall W, the needle 185 engages the tissue at the contact point P1 as the needle moves around the distal hub 181a. As shown in FIG. 18B, when the needle moves away from the distal hub 181a, the tissue wall W is pulled toward the proximal end 181b, forming a small fold F in the tissue. As the treadmill assembly continues to rotate, the next needle 185 engages the tissue wall and the tissue wall is firmly constrained to the treadmill assembly 176 along the length of the conveyor 180.

  As shown in FIG. 18C, once the tissue wall W is firmly constrained to the treadmill assembly 176, the distal end 174 of the flexible tube 177 is bent at the bendable portion 190, The treadmill assembly 176 can be moved away from the tissue wall W. Bending of the flexible tube 177 can be accomplished using a control wire and actuator located at the proximal end of the catheter, as already described with respect to the embodiment of FIG. By moving away, the additional tissue is pulled proximally and the tissue fold F is stretched.

  In FIG. 18D, tissue fold F is stretched across bendable portion 190 of flexible tube 177 to form contact point P2. This allows a pointed needle or closure to extend through one of the slots 186 in the bendable site 190 and across all four layers of the tissue wall W. Conveniently, stretching the tissue fold F across the bendable site 190 allows the anchor to be pierced through both the muscular and serosal layers, making it durable for the proximity of gastrointestinal tissue The foundation is brought. For example, the needle 192 can be extended through the slot 186 of the bendable portion 190 and through the root portion of the tissue fold F, and the anchor assembly (as described with respect to any of FIGS. 4-17) can be The heel can be fixed by launching from 192. Alternatively, a closure (as described with respect to FIGS. 5A and 5B) can be used to deliver the anchor assembly through the tissue fold at contact point P2. The treadmill assembly 176 can be disconnected from the tissue wall W by reversing the rotation of the proximal hub 181b.

  Referring now to FIG. 20A, yet another embodiment of an apparatus for forming tissue folds constructed according to the principles of the present invention will be described. Device 200 has a tissue grasping assembly 18 'connected to the distal end of a flexible tube 177' as described with respect to the embodiment of FIG. The flexible tube 177 'preferably includes a plurality of slots 186' that extend through the wall surface to improve tube flexibility while still allowing torsional rotation. Furthermore, the flexible tube 177 'can be made of stainless steel and can be provided with a slot pattern by etching or laser cutting, such as a sinusoidal repeating pattern of slots perpendicular to the longitudinal axis of the tube. Other flexible patterns will be apparent.

  Tissue grasping assembly 18 'is similar to the tissue grasping assembly described with respect to the embodiment of FIG. 1 and includes a pair of jaws 28a', 28b 'between an open state and a closed state about pivot point 29'. Arranged to rotate. Each of the jaws 28a 'and 28b' is preferably provided with pointed teeth 33 'located near the distal end so that the wall W of the tissue can be easily grasped.

  With reference to FIG. 20A, a tissue grasping assembly 18 'has been placed through the esophagus in the vicinity of the tissue wall W and the jaws 28a', 28b 'have been moved to the open position. The tissue grasping assembly 18 'is then moved into contact with the tissue wall W. As shown in FIG. 20B, a tissue grasping assembly 18 'is used to grasp the tissue wall at the first contact point P1. After capturing a portion of the tissue wall W inside the jaws 28a ', 28b', the flexible tube 177 'is moved proximally and the tissue wall W is stretched to form a tissue fold F. The

  Referring to FIG. 20C, after the tissue fold F is formed, the distal end of the flexible tube 177 ′ bends around the bendable site 190 ′ and leaves the tissue grasping assembly 18 ′ away from the tissue wall W. To move. The bending of the flexible tube 177 'can be controlled using an actuator located at the proximal end of the catheter, and the tissue fold F can be stretched.

  In FIG. 20D, the tissue fold F has been stretched across the bendable site 190 ′, so that a sharp needle or closure is removed from one of the slots 186 ′ of the bendable site 190 ′ from the tissue. All four layers of the wall surface W can be stretched across. The needle 192 'can then be extended from the slot 186' of the bendable site 190 'through the contact point P2 and the tissue fold F. An anchor assembly (eg, as described with respect to any of FIGS. 4-17) can then be fired from the needle 192 'to secure the heel. Alternatively, a closure (eg, as described with respect to FIGS. 5A and 5B) can be used to deliver the anchor assembly through the tissue fold at contact point P2.

  Referring now to FIG. 21, an anchor delivery system configured for use with the adjustable anchor assembly of FIGS. Although FIG. 21 illustrates an anchor delivery system used in conjunction with the anchor assembly 60 of FIG. 7, this should in no way be construed as limiting the invention. Also, to secure the tissue folds, the delivery system of FIG. 21 can be used in combination with devices for forming tissue folds such as the devices 10, 175, 200 described above and other devices described below. it can. Alternatively, the delivery system can be used for any other application that requires delivery of the anchor assembly, or can be used in combination with any other device that requires delivery of the anchor assembly. it can.

  In FIG. 21A, the distal region of anchor delivery system 250 is positioned near tissue fold F on tissue wall W. Anchor delivery system 250 has a flexible delivery tube 252 having a lumen 253. The flexible delivery tube 252 can be configured to be delivered through the patient's mouth and esophagus to a gastrointestinal lumen, such as the stomach. The lumen 253 of the delivery tube 252 preferably has a diameter of less than about 5 mm, and more preferably has a diameter of about 2-3 mm. The flexible delivery tube 252 preferably includes a plurality of slots 254 that extend through the wall surface to improve tube flexibility while still allowing torsional rotation. The bendable portion 255 can be formed by the slot 254. Preferably, the flexible delivery tube 252 is made of stainless steel and has a slot pattern by etching or laser cutting. Preferably, the slot pattern is a sinusoidal repeating pattern composed of slots orthogonal to the longitudinal axis of the tube. Additional patterns and / or other patterns will also be apparent.

  In addition, the anchor delivery system 250 has a delivery needle 260. The length of the needle 260 is preferably less than 2 cm, more preferably 1.5 cm. Needle 260 preferably has a pointed distal end 262, a lumen 264, a slot 266 extending proximally from distal end 262, and a proximal eyelet 268.

  The lumen 264 of the needle 260 is dimensioned to allow a distal anchor to be placed therein. As already mentioned, anchor delivery system 250 is illustrated in combination with anchor assembly 60 of FIG. In FIG. 21A, a distal anchor 62 is disposed inside the lumen 264 of the needle 260. A suture 39 extending from the distal anchor 62 to the proximal anchor 64 passes through the needle slot 266. While the needle 260 is preferably disposed within the lumen 253 of the flexible delivery tube 252 distal to the bendable portion 255, the proximal anchor 64 is preferably proximal to the bendable portion 255. Located in the delivery tube 252 on the side.

  In this configuration, the distal anchor 62 can be extended by the needle 260 while the bendable site is actuated or bent, such as when the anchor delivery system 250 is used in combination with the plication system described above. The proximal anchor 64 can then be advanced through the bendable portion 255 after the bendable portion has been straightened again. The distance, or length, of the suture 39 extending between the distal anchor 62 located distal to the bendable site and the proximal anchor 64 located proximal to the bendable site is preferably about 2 cm. It is above, More preferably, it is 4 cm or more.

  Needle 260 is connected proximally to needle pusher bar 270 to facilitate movement of the needle beyond the distal end of flexible delivery tube 252. Needle push bar 270 extends to a control actuator (not shown) located at the proximal end of anchor delivery system 250. The push rod 270 may optionally be biased with a spring (not shown), for example to facilitate perforation of the tissue wall W and passage of the tissue fold F of the needle 260.

  Anchor delivery system 250 further includes an anchor push bar 280 that is removably disposed through eyelet 268 of needle 260 and is configured to push distal anchor 62 out of lumen 264 of needle 260. Like needle push bar 270, anchor push bar 280 extends to a control actuator (not shown) located at the proximal end of anchor delivery system 250. The actuators controlling the push rods 270 and 280 are preferably at least partially connected so that the relative movement between the two push rods can be limited and / or eliminated if desired. A push bar 280 passes through the proximal loop of the suture formed by the knot 69 of the suture 39, and the suture loop is passed between the needle push bar 270 and the anchor push bar 280. ing. This facilitates unidirectional adjustment of the length of the suture located between the distal anchor 62 and the proximal anchor 64, as described below.

  In FIG. 21B, push rods 270 and 280 are simultaneously advanced distally with sufficient force, eg, due to spring loading, so that the sharp distal end 262 of needle 260 penetrates tissue wall W, Head forward toward 襞 F. As the needle is advanced, the bendable portion 255 of the flexible delivery tube 252 may optionally be bent as described above for the plication device (see FIG. 3E). Then as seen in FIG. 21C. Anchor push rod 280 is advanced distally relative to needle push rod 270 and needle 260 and abuts distal anchor 62 to move the anchor from lumen 264 of needle 260 to the distal side of tissue fold F. Push out. The suture thread 39 is also expelled from the slot 266 and placed through the heel F.

  Upon delivery, the longitudinal axis of the distal anchor 62 is substantially parallel to the longitudinal axis of the needle 260. However, once the anchor 62 is pushed out of the needle 260, the suture tension causes the anchor to rotate about 90 ° about the anchor's longitudinal axis so that the anchor's longitudinal axis is aligned with the needle 260's longitudinal axis. It becomes substantially orthogonal. This rotation of the distal anchor 62 prevents the distal anchor from being pulled back through the tissue wall W. An outward flare (not shown) may be provided at one or both ends of the anchor 62 to facilitate such rotation when in contact with the tissue wall.

  In FIG. 21D, the anchor push rod 280 is pulled back proximally within the lumen 264 of the needle 260, the needle is pulled back into the flexible delivery tube 252 by the push rod 270, and the delivery system 250. Is pulled back proximally across tissue fold F. A distal anchor 62 is located distal to the tissue fold, a suture 39 extends through the fold, and a proximal anchor 64 is located proximal to the fold inside the delivery tube 252. Yes. If the bendable portion 255 is bent during placement of the distal anchor 62 (see FIG. 3E), it is straightened to facilitate delivery of the proximal anchor.

  The delivery tube 252 is then retracted proximally relative to the push rods 270 and 280 so that the needle 260 exits the delivery tube lumen 253 proximally of the tissue fold F and is proximal anchor 64. Provides space for the to exit the lumen. The delivery tube 252 or the entire delivery system 250 is then withdrawn, and the proximal anchor 64 is expelled from the delivery tube lumen 253, as seen in FIG. 21E. The delivery tube 252 is then advanced again and / or push rods 270 and 280 are retracted simultaneously and the needle 260 is again placed inside the lumen 253 of the delivery tube.

  The flexible delivery tube 252 is advanced relative to the needle 260 to push the proximal anchor 64 in the distal direction. As seen in FIG. 21F, the proximal suture loop formed by the knot 69 of the suture 39 is hooked to the proximal end of the needle 260 and the anchor push rod 280, causing the distal anchor 62 to fold over the tissue. Pull close to F. By continuing advancement of the delivery tube 252, the length L of the suture 39 positioned between the distal anchor 62 and the proximal anchor 64 is unidirectional while pressing the proximal anchor 64 toward the tissue fold. Adjustment, or shortening, secures the heel between the proximal and distal anchors.

  Once the length L is adjusted by the anchor assembly 60 so that the tissue fold F is firmly fixed in place, the anchor push bar 280 is moved proximally relative to the needle push bar 270 and the needle 260. The distal end of the anchor push rod 280 is retracted proximally to exit the needle 260 through the eyelet 268. As seen in FIG. 21G, the suture loop formed by the knot 69 of the suture 39 slides off the distal end of the anchor push rod 280 and the anchor assembly 60 moves away from the anchor delivery system 250. The anchor delivery system 250 can then be removed from the patient. Alternatively, needle 260, needle push rod 270, and anchor push rod 280 may be retracted proximally and removed from lumen 253 of anchor delivery tube 252. A further anchor assembly 60 can then be loaded into the needle 260 and delivery tube 252 from the proximal end of the delivery tube, leaving the distal end of the delivery tube in the patient's body. This additional anchor assembly can be placed, for example, through additional tissue folds.

  The delivery system 250 can optionally have a cutting device (not shown) for removing the portion of the suture that extends proximally from the proximal anchor 64 after adjustment. Alternatively, an auxiliary device may be provided to remove the length of the proximal portion of such a suture. As yet another alternative, an unnecessary length of suture may be left in the patient's body after surgery.

  To reduce the number of steps required to position and adjust the anchor assembly 60, once the distal anchor 62 is positioned as shown in FIG. It can be retracted proximally to be pulled back across the tissue fold F while remaining outside the lumen 253. This is in contrast to the method described with respect to FIG. 21D where the needle is placed inside the delivery tube prior to withdrawal back across the tissue fold. Proximal anchor 64 is positioned from delivery tube lumen 253 by continuing to retract anchor delivery system 250 or delivery tube 252 proximally. The anchor assembly 60 can then be adjusted in one direction as previously described.

  Advantageously, the anchor delivery system 250 provides a great deal of control for the healthcare professional in all steps of anchor assembly placement. Such control provides the healthcare professional with sufficient opportunity to stop positioning the anchor assembly. After the needle 260 has passed through the tissue fold F, as seen in FIG. Alternatively, after deploying the distal anchor 62 as seen in FIG. 21D, the healthcare worker cuts the suture connecting the proximal anchor and the distal anchor without deploying the proximal anchor. You can choose that. As a result, the distal anchor will simply pass through the patient's digestive system harmlessly. As yet another example, a healthcare worker may choose not to tighten the proximal and distal anchors after placement and leave the anchor in place without securing the tissue fold F. Still further, medical personnel can discard the formation of tissue folds by re-tightening or cutting the anchor assembly after placement.

  As will be apparent to those skilled in the art, anchor delivery system 250 is used in combination with the devices 10, 175, or 200 described above to position the anchor assembly through the heel F formed by these devices. Sometimes, the flexible delivery tube 252 may be comprised of the respective flexible tube 14, 177, or 177 'of the device 10, 175, or 200, or these flexible tubes 14, 177, or 177. May be advanced through. Similarly, a needle 260 may be configured with each needle 34, 92, or 92 'of the device 10, 175, or 200. Alternatively, the needle 260 may be configured with the closure 50 of FIG. It will be appreciated that each component of the anchor delivery system 250 may be configured with, or advanced through, the corresponding components of other tissue plication devices described below.

  With reference now to FIG. 22, another anchor delivery system is described. Similar to anchor delivery system 250 of FIG. 21, anchor delivery system 300 of FIG. 22 is configured for use with the adjustable anchor assembly of FIGS. In FIG. 22, the anchor delivery system 300 is illustrated as being used with the anchor assembly 60 of FIG. 7, but this should in no way be construed as limiting the present invention. Also, the delivery system 300 can be used in combination with devices for forming tissue folds, such as the devices 10, 175, 200 described above and other devices described below, to secure tissue folds. Alternatively, the delivery system can be used for any other application that requires delivery of the anchor assembly, or can be used in combination with any other device that requires delivery of the anchor assembly. it can.

  FIG. 22A shows the distal region of anchor delivery system 300. System 300 has a flexible delivery tube 302 having a lumen 303. The flexible delivery tube 302 can be configured to be delivered through the patient's mouth and esophagus to a gastrointestinal lumen such as the stomach. The flexible delivery tube 302 preferably includes a plurality of slots 304 extending through the wall surface to improve tube flexibility while still allowing torsional rotation. The bendable portion 305 can be formed by the slot 304. Preferably, the flexible delivery tube 302 is made of stainless steel and has a slot pattern by etching or laser cutting. Preferably, the slot pattern is a sinusoidal repeating pattern composed of slots orthogonal to the longitudinal axis of the tube. Additional patterns / other patterns will be apparent to those skilled in the art.

  In addition, the flexible delivery tube 302 has an end region 306 connected to an anchor tube 307 having a lumen or hole 308. As best seen in FIG. 22B, the lumen 308 of the anchor tube 307 communicates with the lumen 303 of the delivery tube 302 by a through slot 309. A proximal anchor 64 is disposed inside the anchor tube 307 while a distal anchor 62 is disposed inside a needle 260 ′ located inside the delivery tube 302.

  Suture 39 passes from distal anchor 62 out of needle 260 'through slot 266'. The flexible delivery tube 302 then passes through the through slot 309 to the anchor tube 307. After passing the proximal anchor 64, the suture 39 returns to the delivery tube 302 through the penetration slot and the suture loop formed by the knot 69 of the suture 39 is placed between the push rods 280 '. Thus, the anchor push rod 280 'is passed through.

  Needle 260 ′, needle pusher 270 ′, and anchor needle pusher 270 ′, and anchor pusher 280 ′ are pushrods 270, substantially similar to needles 260 and 280 described with respect to anchor delivery system 250 in FIG. 21, respectively. Are identical. Further, anchor assembly 60 can be delivered from and adjusted by anchor delivery system 300 in a manner similar to that described above with respect to system 250.

  In FIG. 22A, the anchor tube 307 of the anchor delivery system 300 is illustrated as a relatively short tube having a lumen or hole 308 configured to place the proximal anchor 64 therein. However, as an alternative, the anchor tube 307, lumen 308, and / or through slot 309 may extend all the way to the proximal end of the flexible delivery tube 302 of the delivery system 300, or extend over a portion thereof. It should be understood that it may be. Conveniently, such a configuration would cause the anchor assembly 60 to be re-loaded into the anchor delivery system 300, for example, while the distal region of the anchor delivery system 300 remains in the patient's body. To allow easy loading from the proximal end. Furthermore, such a configuration simplifies system manufacture.

  The anchor delivery system 300 is illustrated as having only one anchor assembly 60 disposed therein. However, loading the delivery system 300 with multiple anchor assemblies allows multiple penetrations through various points in the tissue fold, through different (eg, adjacent) folds, or through other tissue structures. It should be understood that the anchor assembly can be easily inserted. Multiple distal anchors 62 are preferably loaded inside the needle 262 ′ of the flexible insertion tube 302, while multiple proximal anchors 64 are preferably within the lumen 308 of the anchor tube 307. Is loaded.

  Compared to system 250 of FIG. 21, the advantage of anchor delivery system 300 is that both the proximal anchor and the distal anchor are located distal to the bendable portion of the delivery tube during delivery. is there. This can reduce the initial length of suture that must be located between the anchors, and can reduce the length of unwanted sutures that extend to the proximal side of the proximal anchor after delivery and adjustment. . In addition, delivery can be simplified because both the proximal and distal anchors can be delivered while the bendable portion of the delivery tube remains bent. Further, placing the proximal anchor in a separate anchor tube eliminates the need to push the needle out of the flexible delivery tube on the proximal side of the tissue fold to place the proximal anchor, which can be mistaken for the needle. The risk of puncturing tissue is reduced.

  With reference to FIG. 23, another alternative anchor delivery system will be described. Similar to anchor delivery systems 250 and 300 of FIGS. 21 and 22, anchor delivery system 400 of FIG. 23 is configured for use with the adjustable anchor assembly of FIGS. Although the anchor delivery system 400 is illustrated as being used with the anchor assembly 60 of FIG. 7, this should in no way be construed as limiting the invention. Also, the delivery system 400 can be used in combination with devices for forming tissue folds, such as the devices 10, 175, 200 described above and other devices described below, to secure tissue folds. Alternatively, the delivery system 400 can be used for any other application that requires delivery of the anchor assembly, or used in combination with any other device that requires delivery of the anchor assembly. Can do.

  FIG. 23 shows the distal region of the anchor delivery system 400. System 400 includes a flexible delivery tube 402 having a lumen 403. The flexible delivery tube 402 can be configured to be delivered through the patient's mouth and esophagus to a gastrointestinal lumen, such as the stomach. The flexible delivery tube 402 preferably includes a plurality of slots through the wall surface to improve tube flexibility while allowing torsional rotation. The bendable portion 405 can be formed by the slot.

  In addition, the anchor delivery system 400 has an insertion needle 260 ″ located in the lumen 403 of the flexible delivery tube 402 distal to the bendable portion 405 during delivery. As already mentioned, anchor delivery system 400 is illustrated in combination with anchor assembly 60 of FIG. Needle 260 '' preferably has sufficient length to place distal anchor 62 and proximal anchor 64 of anchor assembly 60 therein, for example, the length of needle 260 '' is: It is less than about 5 cm, more preferably about 3 cm. The needle 260 '' is substantially identical to the needle 260 of FIG. 21, except that the length is increased.

  In FIG. 23, both the distal anchor 62 and the proximal anchor 64 are located in the lumen 264 "of the needle 260". As suture 39 extends from distal anchor 62 to proximal anchor 64, it passes through needle slot 266 ″ and again. Alternatively, the length of the suture between the proximal anchor and the distal anchor may be located inside the needle during insertion. Conveniently, for example, when the anchor delivery system 400 is used in combination with the plication device previously described, both the proximal and distal anchors of the anchor assembly 60 cause the bendable portion 405 to move or bend. And can be placed through the needle 260 ''.

  Needle 260 '' is connected proximally to flexible needle push tube 420, which allows the needle to be easily moved beyond the distal end of flexible insertion tube 402. Can be translated. As will be apparent to those skilled in the art, the needle 260 ″ and the needle push tube 420 may optionally be manufactured as a single piece. The needle push tube 420 has a lumen 422 and a skive 424 connected to the lumen 422. Needle push tube 420 is connected to a control actuator (not shown) located at the proximal end of anchor delivery system 400. The control actuator may be biased by a spring.

  An anchor push rod 280 ″ that is substantially identical to the previously described anchor push rod 280 is detachably disposed within the lumen 422 of the needle push tube 420 distal to the skive 424. Like push tube 420, anchor push rod 280 "extends to a control actuator (not shown) located at the proximal end of the anchor delivery system. A suture 39 extends proximally from the proximal anchor 64 through the slot 266 ″ of the needle 260 ″, through the skive 424 and into the lumen 422 of the needle push tube 420, and the anchor push rod 280. ”And passes through skive 424 to the knot 69. The proximal loop of suture formed by the knot 69 is trapped around the push rod 280 '' and within the lumen 422 of the needle push tube so that the distal anchor 62 and the proximal anchor 64 The length of the suture located between them can be easily adjusted in one direction. As an alternative to the proximal loop of the suture, a knot 69 is formed at the proximal end of the suture 39 so that the knot is captured between the anchor push tube 280 ″ and the needle push rod 420. Alternatively (see knot K in FIG. 24).

  Anchor assembly 60 allows anchor assembly 60 to be delivered, positioned and adjusted in a manner similar to that described above with respect to anchor delivery system 250 of FIG. Specifically, during placement of the distal anchor 62, the anchor push rod 280 '' is advanced against the proximal anchor 64, which then advances the distal anchor 62 in series. . The push rod is advanced relative to the needle 260 ″ by a distance sufficient to push the distal anchor out of the needle lumen 264 ″, so that the proximal anchor 64 is prematurely pushed out. I can't proceed. To prevent the distal anchor from being pushed out prematurely, a device that restricts movement may be provided. A typical motion control device is described below with respect to FIG. 24, but additional devices that are known per se are also apparent.

  To push the proximal anchor 64 out of the lumen 264 ″ of the needle 260 ″, the length L of the suture 39 located between the proximal anchor and the distal anchor is pulled so that the proximal anchor is in the needle. The needle is retracted or the anchor push rod 280 '' is advanced within the lumen of the needle 260 '' until it is withdrawn from the lumen, or a sufficient distance to push the proximal anchor out of the lumen (or These may be combined). Further, to release the anchor assembly 60 from the anchor delivery system 400 after delivery and adjustment, the anchor 39 loop formed by the knot 69 is no longer captured in the lumen 422 of the needle pusher bar 420. Push bar 280 ″ is retracted to the proximal side of skive 424. After placement of the anchor assembly 60, the delivery system 400 can be removed from the patient's body. Alternatively, needle 260 ″ and needle pusher 420 and anchor pusher 280 ″ can be removed from the patient and loaded with a new anchor assembly so that additional anchors can be placed without having to remove delivery tube 402 from the patient. It may be advanced through the delivery tube 402.

  Compared to the system 250 of FIG. 21, the great advantage of the anchor delivery system 400 is that both the proximal anchor and the distal anchor are located distal to the bendable portion 405 of the flexible delivery tube 402. In the point. Compared to the system 300 of FIG. 22, the great advantage of the anchor delivery system 400 is that both the proximal anchor and the distal anchor are placed inside the needle 260 ″, eliminating the need for an anchor tube and It is in the point that the outside size is made small.

  Referring now to FIG. 24, another embodiment of an anchor delivery system 400 having a motion restriction device will be described. Anchor delivery system 400 ′, except that needle pusher 420 ′ has two skives, a motion limit skive 430 and a one-way adjustment skive 432, both in communication with needle pusher lumen 422 ′. 400 is substantially the same. A suture 39 extends proximally from the proximal anchor 64, through the motion limiting skive 430, and into a lumen 422 'between the anchor push bar 280 "and the needle push tube 420'. The suture thread 39 exits the skive 430 and is tied with a knot K for movement restriction that is captured by the skive 430 by the anchor push rod 280 ″. The suture 39 then continues proximally to the proximal loop of the suture formed by the unidirectional adjustment skive 432 and the knot 69 and captured by the skive 432 around the push rod 280 ″.

  The length of the suture extending between the proximal anchor 64 and the knot K allows the distal anchor 62 to exit the lumen 264 '' of the needle 260 '', while the knot K is the anchor push rod 280 ''. Is specified so that the proximal anchor 64 cannot exit while being captured by the skive 430. For example, in delivering the anchor assembly 60 through the tissue fold, advancement of the push rod 280 '' advances the proximal anchor 64, which then moves the aligned distal anchor 62, Advance until distracted from needle lumen 264 ″ distal to the tissue fold. The knot K limits the advanceable distance of the anchor push rod 280 ″ and prevents the proximal anchor 64 from being prematurely placed.

  When the anchor delivery system 400 ′ is again placed proximal to the tissue fold, the anchor push rod 280 ″ is retracted to the proximal side of the motion limiting skive 430 and the knot K escapes from the skive 430. And the placement of the proximal anchor 64 is facilitated. Advance the proximal anchor 64 by retracting the needle 260 ″ or the anchor push bar 280 ″ again until the length of the suture between the two anchors is pulled and the proximal anchor is withdrawn from the needle Can be placed by pushing the proximal anchor out of the needle.

  The anchor assembly can then be adjusted in one direction by a suture loop trapped in the skive 232 as previously described. After the adjustment is complete, the anchor push rod 280 ″ is retracted to the proximal side of the one-way adjustment skive 432 so that the suture loop formed by the knot 69 of the suture 39 can escape from the skive 432. It becomes like this. Similar to the anchor delivery systems 250 and 400 described above, after the anchor assembly is in place, the system 400 'can be removed from the patient's body or reloaded while leaving the flexible tube 402 in the patient's body. be able to. A significant advantage of anchor delivery system 400 'when compared to system 400 of FIG. 23 is that the motion limit skive 430 reduces the risk of premature placement of the proximal anchor 64.

  With reference to FIG. 25, yet another alternative anchor delivery system will be described. Anchor delivery system 500 is configured to deliver a plurality of adjustable anchor assemblies without the need for reloading or removal from the patient. The delivery system 500 can be used in combination with a device for forming a tissue fold, can be used for any other application that requires delivery of an anchor assembly, or an anchor assembly. Can be used in combination with any other device that requires delivery of. In FIG. 25, the anchor delivery system 500 is illustrated loaded with a plurality of anchor assemblies 60 of FIG. 7, which should in no way be construed as limiting the invention.

  FIG. 25 shows the distal region of anchor delivery system 500. The system 500 includes a flexible delivery tube 510, a flexible needle tube 520, an anchor push bar 530, and a skive bar 540. Delivery tube 510 is substantially the same as delivery tube 402 described above, but has a lumen 511 and an optional bendable portion 512. Needle tube 520 has delivery needle 522, anchor lumen 523, and skive hole 524. The lumen 523 extends through the needle tube 520 from the proximal end of the needle tube 520 to the needle 522, and the anchor push rod 530 and the anchor assembly 60 are disposed in the lumen. The hole 524 preferably terminates just proximal to the needle 522 and a skive rod 540 is disposed within the hole. To facilitate manufacturing, the hole 524 may optionally be replaced with a lumen (not shown) that extends all the way to the needle 522.

  Further, the needle tube 520 has two through holes, a first motion limiting through slot 526a, a first one-way adjusting skive 528a, a second motion limiting through-slot 526b, and a second one-way adjusting skive 528b. Has two skives. All skives and through slots communicate with skive holes 524. Further, the through slot 526 communicates with the anchor lumen 523 and provides a passage between the anchor lumen and the skive hole 524. Further, skive 528 communicates with the outside of needle tube 520 and provides a passage between the exterior and skive hole 524.

  As already mentioned, the anchor delivery system 500 is illustrated with the anchor assembly 60 loaded. A first anchor assembly 60a and a second anchor assembly 60b are disposed within the anchor lumen 523 and the assembly 60a is distal to the assembly 60b. An anchor push rod 530 is located within lumen 523 proximal to second assembly 60b.

The first suture 39a of the first anchor assembly 60a extends proximally within the lumen 523 from the first distal anchor 62a to the first proximal anchor 64a, and the first proximal It extends through the anchor 64a. The suture 39a then extends from the anchor lumen 523 to the skive hole 524 via the first motion limited through slot 526a. The suture 39a loosely surrounds the skive bar 540 and is tied to itself by the first knot K _1A for restricting movement, and the loop of suture formed by the knot K _1A is around the skive bar 540. I am caught by The length of suture located between a first proximal anchor 64a and the first knot K _1A for movement restrictions, can feed the first distal anchor 62a from the lumen 523 of the needle tube 520 Long enough to allow, but not long enough to allow the first proximal anchor 64a to be extended from the lumen. Rather, this length of suture is pulled by the loop formed by the knot Kam and is trapped around the skive rod 540 against the first through slot 526a. In this way, the suture loop formed by the knot K _1A provides movement limitation when positioned around the skive bar 540. After placing the first distal anchor 62a, the skive bar 540 can be translated relative to the suture loop to release the loop from the bar.

The first suture 39a continues proximally from the knot K _1A to the first one-way adjustment skive 528a. Then, the suture 39a surrounds loosely skive rod 540 again, are tied off to itself at the first one-way adjusting knot K _1B. As described above, while being disposed around the skive rod 540 in the first skive 528a, the loop of suture formed by the knot K _1B, the first anchor assembly 60a after placement in one direction Can be used for adjusting. The length of suture located between a first proximal anchor 64a and the first knot K _1B for unidirectional adjustment, to allow feeding of the anchor from the lumen 523 of the anchor tube 520 Long enough.

The second suture 39b of the second anchor assembly 60b moves the second distal anchor 62b and the second proximal anchor 64b into the second motion limiting through slot 526b and the second one-way adjustment. Connected to skive 528b in a manner similar to that described with respect to first suture 39a of first anchor assembly 60a. The suture loop formed by the second knot K _2A for restricting movement prevents premature payout of the second proximal anchor 64b, while the knot K for the second one-way adjustment. A suture loop formed by _2B allows for adjustment of the length of the suture located between the second distal anchor 62b and the second proximal anchor 64b.

  Anchor assemblies 60a and 60b can be inserted from and adjusted by anchor delivery system 500 in a manner similar to that described above with respect to system 400 ′ of FIG. Can do. Specifically, during delivery of the first distal anchor 62a, the anchor push bar 530 is advanced against the second proximal anchor 64b, and then the second proximal anchor 64b is in series. Advance the second distal anchor 62b and the first proximal anchor 64a in series. The push rod is advanced relative to the needle tube 520 a sufficient distance to push the first distal anchor 62a out of the anchor lumen 523.

  As the push bar 530 is further advanced, the suture loop formed by the first motion restriction knot Ku is hooked into the first through slot 526a and the first proximal anchor 64a is prematurely tubed. It is prevented from being pushed out of the cavity 523. When the first proximal anchor is ready to be placed, the skive rod 540 can be retracted proximally of the first motion limiting through slot 526a and the suture loop formed by the knot Ku is Free from skive sticks. The first proximal anchor 64a can then be positioned by advancing the anchor push rod further distally toward the second anchor assembly 60b. The second anchor assembly advances the first proximal anchor 64a from the needle 522.

Then, the first anchor assembly 60a, first skive 528a, a first adjustment of the knot K _1B suture loop formed by, and using a delivery tube 510, in one direction as described above Can be adjusted. Once adjusted, skive rod 540 can be further retracted into skive hole 524 to a position proximal to first skive 528a, thereby releasing first anchor assembly 60a from anchor delivery system 500. Is done. Then, the second anchor assembly 60b, a second through slot 526b, the second skive 528b, and using a second knot _{K 2A} and _{K 2B,} may be arranged and adjusted in a similar manner .

  As will be apparent to those skilled in the art, anchor delivery system 500 has been illustrated for a configuration suitable for delivery of as few as two anchor assemblies, but a combination of, for example, a motion limiting through slot and a unidirectional adjustment skive may further Any number of anchor assemblies can be accommodated. In addition, spacers such as digestible spacers, wax spacers, polymer spacers, etc. are provided between anchors and / or between anchor assemblies to reduce the risk of anchors or anchor assemblies being prematurely placed. be able to. Further techniques for providing spacing and for limiting movement are also apparent.

  Next, with reference to FIG. 26, another embodiment of the anchor delivery system 500 will be described. For illustrative purposes, the flexible delivery tube 510 is omitted in the system 500 'of FIG. However, it should be understood that the anchor delivery system 500 'preferably has a flexible delivery tube 510.

Anchor delivery system 500 ′ is substantially identical to system 500 except that the first and second through slots 526 a ′ and 526 b ′ are not in communication with skive hole 524. Instead, the through slot 526 ′ provides an opening between the anchor lumen 523 and the exterior of the needle tube 520. Further, the needle tube 520 have respective first and second first and second skive 527a and 527b for movement limited to restrain the loop of suture formed by knot K3j and K _1A for motion restriction ing. Anchor delivery system 500 ′ is considered easier to manufacture than system 500. Furthermore, because the substantial length of the first suture 39a and the second suture 39b is located outside the needle tube 520 within the lumen 511 (see FIG. 25) of the delivery tube 510 during delivery, It is expected that suture management will improve. Similar to anchor delivery system 500, delivery system 500 ′ can include a spacer between the anchor and / or anchor assembly to reduce the risk of the anchor being prematurely placed.

Anchor delivery systems 500 and 500 ′ of FIGS. 25 and 26, respectively, provide for the delivery and placement of multiple adjustable anchor assemblies from anchors arranged in a line within the lumen of the needle tube. . FIG. 27 shows a first embodiment of another anchor delivery system in which multiple anchor assemblies are arranged around a needle tube without requiring reloading or removal from the patient. Delivered and placed from side-by-side chambers or revolvers. To load a radial array of anchor assemblies into a needle tube, the revolver and / or needle tube can be rotated to align the needle tube with each successive chamber of the revolver.
In FIG. 27, the anchor delivery system 600 includes a flexible delivery tube 610, a flexible needle tube 620, an anchor push bar 630, and a revolver 640. The flexible delivery tube 610 has a lumen 612. Needle tube 620 includes a needle 622, an anchor loading slot 624, an anchor delivery system or lumen 626, and a plurality of adjustment skives 628. The skive 628 is disposed over the length of the needle tube 620 and can optionally be disposed at various radial locations around the needle tube 620. Anchor push bar 630 is movably disposed in anchor lumen 626 of needle tube 620 for placement and adjustment of anchor assembly 60, and both needle 622 and anchor slot 624 are located in lumen 626. I'm in touch. A revolver 640 having a plurality of chambers 642 is preferably connected to or integrated with the flexible delivery tube 610. Chamber 642 communicates with lumen 612 of flexible delivery tube 610.

  Chamber 642 is preloaded with a plurality of anchor assemblies 60. Further, the lumen 626 of the needle tube 620 is preferably preloaded with a first anchor assembly 60a. As already mentioned, suture 39 is proximally moved from anchor assembly 60 to skive 628 so that the length of the suture located between the proximal anchor and distal anchor of each assembly can be easily adjusted. In the skive 628, the suture 39 forms a knotted loop K, which is reversibly constrained within the lumen 626 of the needle tube 620 by an anchor push bar 630.

  First, the suture 39a of the anchor assembly 60a extends proximally from the first proximal anchor 64a to the first skive 628a, through the anchor loading slot 624, where A suture loop Ka with one knot is formed. In use, the anchor push rod 630 can be used to pay out the first anchor assembly 60a from the lumen 626 of the needle tube 620, eg, the distal anchor 62a is located distal to the tissue fold. And a proximal anchor 64a is placed proximal to the tissue fold. When the adjustment is completed in the manner described above, the anchor push rod 630 can be retracted proximally to a position proximal to the first skive 628a and the suture loop with the first knot is positioned in the lumen 626. Released from. Withdrawing anchor delivery system 600 proximally relative to first anchor assembly 60a completely removes suture 39a from the delivery system and completes the placement of first anchor assembly 60a.

  As previously described, each chamber 642 of the revolver 640 communicates with the lumen 612 of the flexible delivery tube 610. This facilitates the continuous anchor assembly 60 into the needle tube 620 by aligning each loaded continuous chamber 642 of the revolver 640 longitudinally and radially with the needle tube anchor loading slot 624. Can be loaded. For example, when the anchor push rod 630 is retracted to the proximal side of the anchor loading slot 624 when releasing the suture loop Ka with the first knot from the lumen 626, a second anchor-position disposed in the chamber 642b. Optionally, the needle tube 620 and revolver 640 may be initially aligned so that the assembly 60b falls through the anchor loading slot 624 and into the lumen 626 of the anchor tube 620. After placement, adjustment and release of anchor assembly 60b, subsequent loading of anchor assembly 60c or the like can be accomplished by rotating needle tube 520 to revolver 540 / delivery tube 510 or vice versa. it can.

  In this manner, multiple anchor assemblies 60 can be delivered and positioned without requiring reloading or removal of the anchor delivery system 600 from the patient. In FIG. 27, the revolver 640 is illustrated with three chambers 642 loaded. However, as will be apparent to those skilled in the art, any other number of chambers and anchor assemblies can be provided. Furthermore, an optional motion restriction device may be provided. Further, the appropriate radial direction of each of delivery tube 610, needle tube 620 (and needle tube anchor loading slot 624 and skive 628), anchor push rod 630, and revolver 640 (and each successive chamber 642 of the revolver). And detents, color identification, or other mechanisms can be provided to facilitate longitudinal alignment.

  With reference now to FIGS. 28-34, a further plication device for forming tissue plications will be described. FIG. 28 shows another embodiment of the apparatus 200 of FIG. The apparatus 200 ′ is configured to form and approach a plurality of tissue folds F on the tissue wall W simultaneously or sequentially. The device 200 'can be used in combination with any of the anchors and anchor delivery systems described above, and any applicable alternative anchor or system to collectively secure the approached tissue folds. The approach and fixation of multiple tissue folds is believed to have considerable utility in performing various medical procedures such as, for example, gastric reduction.

  In FIG. 28, the device 200 'has a plurality of bendable flexible tubes 177', each with a tissue grasping assembly 18 '. The tubes 177 ′ are preferably biased so that they expand outwardly at the distal side of the sheath 650. Thereby, the site | part formed in the tissue wall W to form the tissue fold F can be separated by an appropriate distance before the approach, and the fold is further formed to form the wall of the tissue. After releasing W, the tube can be elastically returned to the expanded state. Tube 177 'is preferably translatable relative to sheath 650. As seen in FIG. 28B, the flexible tube 177 'bends inward toward the longitudinal axis of the device 200' to form a suitable tissue fold F. As will be apparent to those skilled in the art, the amount of outward bias applied to the tube 177 'is such that a suitable initial separation distance L is achieved between the tissue grasping assemblies for the desired medical procedure. Can be specified. Further, to reduce the delivery profile of the device 200 ', the flexible tube 177' may be positioned within the sheath 650 (or other outer sheath) during delivery.

  With reference to FIG. 29, another embodiment of the apparatus 10 of FIG. 1 with backside stabilization will be described. All of the aforementioned plication devices include a tissue grasping assembly in the distal region such that the tissue grasping assembly engages and stretches a portion of the tissue wall within the GI lumen at the first tissue contact point. It is configured. A second tissue contact point is then established on the tissue wall, originally at a location proximal to the first tissue contact point or aligned with the first tissue contact point. The tissue engaged by the tissue grasping assembly is then moved to a position proximal to the second tissue contact point to form a tissue fold to move the anchor assembly, eg, the muscle layer of the tissue wall and It can be delivered through the serosal layer and through the tissue fold.

  The device 10 'of FIG. 29 is adapted to establish a third tissue contact point at another location that is originally proximal to the first tissue contact point or aligned with the first tissue contact point. 1 is a first embodiment of a device configured in, and further embodiments will be described later. When the tissue engaged by the tissue grasping assembly is moved to a position proximal to both the second and third tissue contact points, the tissue scissors cause the second and third contact points to move on both sides of the scissors. To be formed. Second and third contact points provide stabilization of both the front and back of the tissue fold, respectively. When the optional anchor assembly is delivered through the tissue fold from the vicinity of the second tissue contact point, the dorsal stabilization at the third tissue contact point reduces tissue tenting. And can facilitate the delivery of the anchor.

  In FIG. 29, the device 10 'of the present invention has a torsionally rotatable catheter 11' that is delivered to the patient's gastrointestinal lumen, eg, through the patient's mouth and esophagus. Can be configured. The catheter 11 'has a distal region 12' and has first and second flexible tubes 13 and 14 extending from and connected to the distal region 12 '. Tubes 13 and 14 are connected by a hinge assembly 20 and a tissue grasping assembly 18 is disposed at the distal end of the flexible tube 13. The tissue grasping assembly is connected to a control wire (not shown) that extends through the tube 13 to the proximal region (not shown) of the catheter 11 '.

  The distal region 12 ′ of the device 10 ′ is substantially similar to the distal region 12 of the device 10 of FIG. 1 except that the distal region 12 ′ further includes a back stabilizer 700 that can be selectively deployed. Are the same. The back ballast 700 is preferably made from a loop of shape memory material such as Nitinol and has a wire loop 710 connected to a control wire 720 extending from a wire tube 730. The proximal region of the catheter 11 'has an actuator (not shown) in communication with the tissue grasping assembly control wire and control wire 720 for operating the tissue grasping assembly and back stabilizer, respectively.

  With reference to FIGS. 30A-30E, a method of using the device 10 'of FIG. 29 to form a tissue fold with a dorsal stabilized surface will be described. In FIG. 30A, the device 10 ′ is delivered to the treatment site by the delivery sheath 740 with the wire loop 710 compressed inside the delivery sheath into a reduced delivery configuration. In FIG. 30B, the distal region 12 'of the catheter 11' is advanced distally of the delivery sheath 740, resulting in the wire loop 710 expanding into a free space configuration. In FIG. 30C, the control wire 720 of the back ballast 700 is retracted proximally, retracting the wire loop 710 to the intermediate standby position. In FIG. 30D, a tissue fold F is formed on the tissue wall W by the distal region 12 ', for example, as described above with respect to FIG.

  In FIG. 30E, tension from the control wire 720 is released and the wire loop 710 moves elastically and returns toward the free space configuration. The wire loop 710 of the back stabilizer 700 establishes a third tissue contact point on the back of the tissue fold F, providing back stabilization to the tissue fold. Establishing a dorsal stabilization / opposing third tissue contact point is expected to facilitate the formation and fixation of the serosa-serosa fold and simplify insertion of the anchor assembly through the tissue fold. The

  As will be apparent to those skilled in the art, the size, length, or diameter of the wire loop 710 can be adjusted to facilitate stabilization of the dorsal surface of various sizes of tissue. Further, the wire loop 710 may be provided as a substantially stagnant loop, i.e. the loop may not be retractable by the control wire 720. In such a configuration, in addition to providing stabilization, the wire loop 710 can apply pressure to the tissue fold as it is formed to facilitate fold formation.

  Referring now to FIG. 31, yet another tissue brazing device with optional backside stabilization will be described. The device 800 is configured to draw tissue straight on the tissue wall W to form a tissue fold F. The device includes a catheter 810 having a tissue grasping assembly 18, such as a tissue grasping assembly as previously described. The tissue grasping assembly has a pair of jaws 28 a, 28 b having pointed teeth 33 arranged to rotate between an open state and a closed state about a pivot point 29 and has a slot 822. Connected to tube 820. A control wire 19 is disposed within the lumen of the tube 820 and extends from the tissue grasping assembly 18 to the proximal end (not shown) of the device 800 for operating the tissue grasping assembly. The tissue grasping assembly 18 is configured to establish a first tissue contact point on the tissue wall W and can be retracted proximally by the tube 820 to facilitate formation of the tissue fold F.

  The device 800 further includes a front link 830a and a back link 830b. The proximal region of the link is pivotally and translatably disposed within the slot 822 of the tube 820. The distal region of the front link 830a is pivotally connected to the anchor delivery tube 840 for delivering the anchor assembly across the tissue fold as previously described, and the distal region of the back link 830b. Is pivotally connected to the back ballast 850. Anchor delivery tube 840 and back stabilizer 850 are preferably biased so that they are substantially aligned with the longitudinal axis of device 800 when no force is applied. Such alignment can be achieved, for example, by forming the element from a spring tube, or by providing the element with an elastic spine such as a Nitinol spine. The tube 840 and the stabilizer 850 are configured to establish second and third tissue contact points, respectively, at the tissue wall W, and as described above, the front and back of the tissue fold formed on the wall Bring about stabilization.

  Referring again to FIG. 31, a method of using the apparatus 800 to form a tissue fold F on a tissue wall W will be described. In FIG. 31A, the tissue grasping assembly 18 has been advanced to the vicinity of the tissue wall W with the proximal end of the link 830 positioned near the proximal end of the slot 822 of the tube 820. The tissue grasping assembly 18 is then driven by retracting the control wire 19 to grasp the tissue and establish a first tissue contact point. Continuing to retract the control wire 19 with the tissue captured, the proximal end of the tube 820 and the assembly 18 are retracted against the link 830 in a substantially linear manner, as seen in FIG. 31B. .

  As the tube 820 is drawn straight, the link 830 slides within the slot 822 of the tube 820 and translates until the proximal region of the link contacts the distal end of the slot 822. As seen in FIG. 31C, withdrawing the tube 820 further proximally beyond the bottom point of this slot 822 causes the link 830 to pivot in both the proximal and distal regions. This in turn causes inward rotation of the anchor delivery tube 840 and the back stabilizer 850 to form second and third tissue contact points, respectively, to form a stabilized tissue fold F at the front and back. Is done. When tube 820 is advanced again, anchor delivery tube 840 and back stabilizer 850 realign with the longitudinal axis of device 800 due to elasticity.

  The previous plication device described above requires a more complex movement than forming a tissue grasping assembly linearly to form a tissue plication F. Limiting the motion of the tissue grasping assembly to form tissue folds to linear motion can reduce the amount of work space required at the treatment site to achieve tissue fold formation Conceivable. As will be apparent to those skilled in the art, instead of retracting tube 820 linearly relative to link 830 to form tissue fold F, link 800 may be advanced linearly relative to tube 820. Also, the back link 830b and back stabilizer 850 (as well as the stabilization of the back of the associated tissue fold F) may be optionally omitted. Alternatively, because the back stabilizer 850 delivers the anchor assembly from the back through the tissue fold F, for example, all or part of the anchor assembly is transferred from the front anchor delivery tube 840 to the back stabilizer. To deliver a multi-part anchor assembly having a first part that can be placed from a front anchor delivery tube and a second part that can be placed by a back stabilizer. You may have an anchor delivery tube. The first and second parts can optionally be connected together to form a composite anchor assembly. Further configurations will be apparent to those skilled in the art.

  Further, the slot 822 may optionally be omitted from the tube 820, instead the proximal and distal stoppers may be placed outside the tube near the distal end of the tube, or the tube And can be formed integrally. In this configuration, the proximal end of the link 830 is pivotally and translatably disposed on the outer periphery of the tube 820, and the proximal and distal stoppers limit the translation of the link relative to the tube. In both this configuration and the configuration of FIG. 31, the tube 820 functions as a linear bearing around which the link 830 can move.

  With reference to FIG. 32, another embodiment of the apparatus 800 of FIG. 31 will be described. Device 800 'is substantially identical to device 800 except that link 830 is replaced with control wire 830' and slot 822 of tube 820 is replaced with skive 822 'of tube 820'. In addition, anchor delivery tube 840 'and back stabilizer 850' have optional pulley eyelets 860a and 860b, respectively, for guiding control wire 830 '. The proximal side of the control wire 830 'is connected to the control wire 19 for the tissue grasping assembly 18 within the lumen of the tube 820'. Control wire 830 'exits the lumen at skive 822' and extends distally through optional pulley eyelet 860. The distal side of control wire 830a 'is connected to anchor delivery tube 840' while the distal side of control wire 830b 'is connected to back stabilizer 850'.

  The length of the control wire 830 ′ is specified such that when the control wire 19 is retracted, movement of the tissue grasping assembly 18 and retraction of the tube 820 ′ occurs prior to the control wire 830 ′ being pulled. . Once the control wire 830 'is pulled, the control wire 830' rotates the anchor delivery tube 840 'and the back stabilizer 850' reversibly inwardly by continuing to retract the control wire 19, and the second and A third tissue contact point is formed, and a tissue fold F having a stabilized front surface and back surface is formed on the wall surface W of the tissue. Similar to device 800, back stabilizer 850 '(and associated control wire 830b') of device 800 'can optionally be omitted.

  With reference to FIG. 33, yet another tissue fold forming device with optional backside stabilization will be described. The device 900 has an outer tube 910 with a rigid or elastic front stabilizer 914a and back stabilizer 914b in the distal region 912. When substantially rigid, the ballast 914 can be formed from, for example, molded stainless steel wire or rod. When elastic, the ballast can be formed from a wire or rod of shape memory material, such as Nitinol, or from a thin stainless steel wire or rod. The durometer of the material used to manufacture the ballast 914 can be specified to achieve the desired degree of stiffness or elasticity.

  The device 900 further includes an inner tube 920 that is coaxially and slidably disposed inside the outer tube 910. A tissue grasping assembly 922 connected to the distal region of the inner tube 910 has a helical coil 924 having a pointed distal end 925. The spiral coil 924 is configured to reversibly engage the tissue by reversibly screwing the coil into the tissue in a manner similar to a wine cork, as indicated by the arrows in FIG. 33A. . As will be apparent to those skilled in the art, the tissue grasping assembly 922 may have a jaw structure similar to that of the assembly 18 instead of or in addition to the helical coil 924. Similarly, any of the tissue plication devices previously described may optionally have a tissue grasping assembly having a helical coil. Additional tissue grasping assemblies, known per se, will also be apparent in light of the disclosure herein.

  FIG. 33 illustrates a method of forming a tissue fold with the apparatus 900. In FIG. 33A, tissue grasping assembly 922 is advanced distal to stabilizer 914 and engages tissue on tissue wall W at a first tissue contact point. The helical coil 924 is screwed into the tissue and then the inner tube 920 is pulled against the outer tube 910 to pull the tissue captured in the assembly 922 proximal to the stabilizer 914 as seen in FIG. 9B. And / or the outer tube is advanced relative to the inner tube. A ballast 914 contacts the tissue at the second and third contact points to form the front and back stabilization of the tissue fold F. When rigid, the cross-sectional width of the tissue fold F can be specified by the separation distance between the front and back ballasts. When elastic, the ballast can be deflected outward, reducing the pulling force required for the coil 924 during crease formation, and possibly detaching the coil from the tissue during crease formation, Or it facilitates the formation of tissue folds by reducing the risk of tearing the tissue.

  As will be apparent to those skilled in the art, if only a second tissue contact point is required, one of stabilizer 914a and stabilizer 914b may optionally be omitted. Furthermore, the device 900 can be used in combination with an anchor delivery system, such as the anchor delivery system described above, which may optionally provide a third tissue contact point. Further, one or both of the stabilizers 914 may be extendable / retractable relative to the distal region 912 of the outer tube 910 of the device 900. Similarly, the ballast may be sized in the body so that a fold of tissue of a specified size can be easily formed.

  Next, with reference to FIG. 34, another embodiment of a wrinkle forming apparatus having backside stabilization will be described. In contrast to the previously described device, the device 950 achieves stabilization of the back of the tissue fold by contact with the skin over the arcuate segment, rather than contact at discrete points or along a line. In FIG. 34, a full 360 ° circumferential contact around the heel is established, but as will be apparent to those skilled in the art, at one or more locations over one or more arcuate segments less than 360 ° May be established.

  Device 950 includes an inner tube 960 and an outer tube 970 that is coaxially disposed. Inner tube 960 has a tissue grasping assembly 18 connected distal to the tube. Further, the device 950 has a knitted mesh 980 having a proximal end 982 connected to the distal end of the outer tube 970 and a distal end 984 connected to the inner tube 960 proximal to the tissue grasping assembly 18. Have. The knitted mesh 980 is preferably made from a polymer or metal wire. As the outer tube 970 is advanced relative to the inner tube 960, the mesh is flipped over, for example, over the tissue fold, resulting in stabilization of the front and back of the tissue fold by arched contact. Obviously, the device 950 can be used in combination with an anchor delivery system to secure a stabilized tissue fold.

  FIG. 34 illustrates a method of using the device 950 to form a stabilized tissue fold. In FIG. 34A, tissue grasping assembly 18 is engaged with tissue wall W at a first tissue contact point. In FIG. 34B, the inner tube 960 is relative to the outer tube 970 such that the proximal end 982 of the knitted mesh 980 advances more distally than the distal end 984 with the tissue engaged to the assembly 18. Withdrawn and / or outer tube 970 is advanced relative to inner tube 980. The knitted mesh is flipped around the tissue fold F and contacted across the entire 360 ° circumferential segment (in FIG. 34B, the knitted mesh 980 is shown in cross section), the front and back of the tissue fold. Bring about stabilization.

  FIGS. 29-34 illustrate an exemplary plication device having an optional member for stabilizing the back of the tissue fold formed by the device. As will be apparent to those skilled in the art, the back stabilization member can optionally be provided in any other wrinkle forming device of the present invention. Further, a dorsal stabilization member can be provided with any anchor delivery system, for example, to reduce tissue bulge when placing the anchor assembly through the tissue fold.

  35-39, an embodiment of a shape fixable guide used with the tool of the present invention will now be described. A shape-fixable guide has already been described in US patent application Ser. No. 10 / 173,203, filed Jun. 13, 2002, which is pending at the same time as the present application. The priority from the application is claimed, and the entirety of this application is hereby incorporated by reference herein. As previously described, the tissue grasping assembly, plication device, anchor delivery system, and anchor assembly of the present invention have been extensively shown for use in a patient's gastrointestinal ("GI") lumen. However, the shape and material properties of the GI lumen vary greatly along its length, so the intraluminal tool of the present invention is properly positioned and visualized at any desired location within the GI lumen. Doing so is expected to present considerable challenges. Transferring forces and torques to such tools over such distances presents additional challenges while the medical personnel and the working end of the tool within the GI lumen are largely separated. Accordingly, it would be desirable to provide a guide device that can provide exposure or targeting, stability, and flexibility to the tool of the present invention when placed in a patient's body.

  The apparatus 1000 of FIGS. 35-39 can be used to transfer diagnostic instruments such as endoscopes such as colonoscopes or gastrointestinal endoscopes, and / or therapeutic instruments as described above, to hollow organs of the body such as the colon, esophagus and / or stomach. These challenges are addressed by making it easier to place through a tortuous or unpredictably supported body structure with less risk of deforming or damaging the organ. The device 1000 selectively locks the shape of the outer tube portion of the device while preventing such tissue from being trapped or pinched between the outer tube and the device. To allow easy advancement to the patient's winding or unpredictably supported body structure. Although device 1000 is illustrated with an outer tube, as an alternative, device 1000 can be selectively rigidized, can be fixed in shape, or can be locked in shape. Or they may have inner ducts on which the diagnostic or therapeutic instrument can be advanced.

  Next, the apparatus 1000 of the present invention will be described with reference to FIG. The device 1000 has a handle 1001, an outer tube 1002, and a distal region 1003 having an atraumatic tip 1004. Handle 1001 includes a lumen 1005 that extends from a Toughy-Borst valve 1006 through an outer tube 1002, a distal region 1003, and an atraumatic tip 1004. Lumen 1005 can be a commercially available standard endoscope, such as endoscope 1100 (see FIG. 40) having steerable distal end 1101, and / or tissue grasping assembly, plication device, anchor delivery, for example. A system or therapeutic device of the present invention, such as an anchor assembly, is configured for easy passage. Although the device 1000 is illustrated with only one lumen, optionally multiple lumens can be provided for passing multiple diagnostic and / or therapeutic instruments. The toffee-bolst valve 1006 can be operated to releasably secure the instrument to the device 1000 when the instrument is inserted into the lumen 1005. As will be described later, the outer tube 1002 is configured to be able to selectively shift between a flexible state and a rigid shape fixed state by an actuator 1007 disposed on the handle 1001.

  In FIG. 36, an exemplary embodiment of outer tube 1002 has multiple nestable members 1010. For illustrative purposes, nestable members 1010 are shown spaced apart from one another, but these members 1010 are arranged such that adjacent surfaces 1011 and 1012 of these members 1010 cooperate. Should be understood. Each of the nestable members 1010 has a central hole 1013 for receiving diagnostic and therapeutic instruments, and preferably further includes three or more tension wire holes 1015. When assembled as shown in FIG. 35, the nestable member 1010 is secured by a plurality of tension wires 1016 extending through tension wire holes 1015 with adjacent surfaces 1011 and 1012 arranged in a cooperating manner. .

  In a preferred embodiment, adjacent surfaces 1011 and 1012 of each nestable member 1010 are contoured to line up with adjacent members so that when tension wire 1016 is loosened, surfaces 1011 and 1012 are It can be rotated. The tension wire 1016 is fixedly connected at the distal end to the distal end of the outer tube 1002 and is connected at the proximal end to a tightening mechanism disposed within the handle 1001. When driven by actuator 1007, tension wire 1016 applies a load that constrains adjacent surfaces 1011 and 1012 of nestable member 1010 together at the current relative position, fixing the shape of outer tube 1002.

  When the tension wire 1016 is unloaded, the tension wire 1016 allows relative angular motion between the nestable members 1010. As a result, the outer tube 1002 successfully passes through a tortuous path or unpredictably supported body structure through any region of the patient's GI lumen, such as the colon, esophagus, and / or stomach. Be flexible enough. On the other hand, when the tightening mechanism is moved, the tension wire 1016 is pulled in the proximal direction, applying a restraining load to the nestable member. This load prevents further relative movement between adjacent members 1010 to stiffen outer tube 1002 and thus when a distal force is applied to the instrument in lumen 1005, the working end of the instrument is Although it is further advanced into the GI lumen, the outer tube 1002 is not pressed against the wall of the lumen and does not lose its spatial position in the unpredictably supported space. An outer tube with a fixed shape absorbs and distributes vector forces and protects the GI lumen.

  Referring now to FIG. 37, an exemplary embodiment of the distal region 1003 and the atraumatic tip 1004 will be described. The distal region 1003 comprises a flexible bend resistant coil 1021 encased within a flexible layer 1022. Layer 1022 preferably comprises a soft elastic hydrophilic coating material (eg, silicone or synthetic rubber) and extends through hole 1013 of nestable member 1010 to form liner 1023 of lumen 1005. Layer 1022 extends at the proximal end to handle 1001 and terminates at the distal end with an enlarged portion 1024 forming an atraumatic tip 1004.

  Layer 1022 is preferably joined to or integrally formed with a flexible elastic cover 1025 encasing the nestable member 1010 in an annular chamber 1026. Cover 1025 provides a relatively smooth outer surface for outer tube 1002 so that tissue is not trapped or pinched when adjacent nestable members 1010 rotate relative to each other.

  According to one aspect of the present invention, the endoscope 1100 can be positioned such that its distal end 1101 is located in the distal region 1003, so that by deflecting the steerable distal end 1101, Angular deflection is provided to the distal region 1003 and the atraumatic tip 1004. To ensure that there is generally no relative motion between the endoscope 1100 or other instrument in the lumen 1005 and the apparatus 1000, the toffee-bolst is adapted to engage the apparatus 1000 with the endoscope / instrument. -Valve 1006 is tightened. In this way, the instrument and distal region 1003 can be advanced through the colon simultaneously while providing steering capability to the device 1000 by the distal end of the endoscope 1100. Thus, when the outer tube 1002 is in a flexible state, the device 1000 can be conveniently advanced with the instrument disposed in the lumen 1005, and the shape of the outer tube 1002 can cause the GI lumen to expand. When fixed to prevent or maintain the orientation of the distal region 1003 relative to the GI lumen, the relative motion between the device 1000 and such an instrument is reduced.

  Further, with reference to FIG. 37, the end portion 1027 of the tension wire will be described. The end portion 1027 has, for example, a ball welded or molded to the end of the tension wire 1016, which can pull the tension wire through the tension wire hole 1015 of the distal-most nestable member 1010. I can't do it. This ensures that these nestable members cannot loosen when the outer tube 1002 is placed in the patient's body.

  Alternatively, the termination 1027 may be provided with a knot formed at the end of the tension wire 1016 or any suitable fastener that prevents the tension wire from being pulled through the tension wire hole of the most distal nestable member. it can. Advantageously, the cover 1025 provides a guarantee that all nestable members 1010 can be safely retrieved from the patient's colon, even in the unlikely event of tension wire failure.

  35 and 38, outer tube 1002, liner 1023, and tension wire 1016 inside lumen 1005 extend from distal region 1003 through outer tube 1002 to handle 1001. Within the handle 1001, each tension wire 1016 passes through a wire lock release 1031 fixedly attached to the handle 1001 and a wire lock 1032 disposed on the slide block 1033. Each tension wire 1016 terminates in a wire tension spring 1034 that keeps the tension wire 1016 lightly pulled even when the outer tube 1002 is in a flexible state. The amount of tension provided by the wire tension spring 1034 is not sufficient to constrain adjacent nestable members 1010 together, but on the other hand, no gaps are formed between adjacent nestable members and the outer tube 1002 Helps to manage tension wire tension or sagging as it bends in various ways.

  Slide block 1033 is mounted to slide along rail 1035 located between restriction blocks 1036 and 1037 and is required for the number of holes through which rail 1035 extends and the number of tension wires 1016 used. It has a rigid block with a number of additional holes. A rack gear 1038 is fixedly connected to the slide block 1033. The rack 1038 meshes with the pinion gear 1039, and then the pinion gear 1039 is driven by a bi-directional pawl 1040 connected to the actuator 1007. Either the protrusion 1041 or 1042 of the bidirectional pawl 1040 can be selectively engaged with the pinion gear 1039 depending on the position of the selection switch 1043.

  If the protrusion 1041 is selected to engage the pinion gear 1039, a gripping operation applied to the actuator 1007 (eg, handgrip 1044) moves the rack 1033 in direction D of FIG. Added. By repeatedly operating the handgrip 1044, the slide block 1033 is sequentially moved further in the direction D, and the restraining load applied to the nestable member 1010 is increased. The slack length of the tension wire 1016 extending downstream of the slide block 1033 is pulled by the wire tension spring 1034. As will be described in detail later with reference to FIG. 39, a wire lock 1032 attached to the slide block 1033 engages the tension wire 1016 and the slide block 1033 moves in direction D and simultaneously retracts the tension wire 1016.

  On the other hand, when the projection 1042 is selected by the selection switch 1043 and is engaged with the pinion gear 1039, the hand grip 1044 is repeatedly operated, so that the slide block 1033 is translated in the direction U, and the tension wire 1016 is nested. The tensile load applied to the possible member 1010 is relaxed. By repeatedly manipulating the handgrip 1044, the slide block 1033 engages the wire lock release 1031 with the wire lock 1032 and releases all tension from the tension wire 1016 except the tension provided by the wire tension spring 1034. To the direction U. This action allows the restraining force applied to the nestable member 1010 to be gradually reduced, and the outer tube 1002 until the wire lock release 1031 engages the wire lock 1032 to return the outer tube to its most flexible state. To be able to move gradually and flexibly.

  The wire lock 1032 and the lock release 1031 will be described in more detail with reference to FIG. The wire lock 1032 includes a jaw 1045 disposed within a collet 1046. The collet 1046 has a tapered conical hole 1047. The jaw 1045 has a beveled outer surface 1048 and teeth 1049 and is biased by a spring 70 toward the surface formed by the tapered conical hole. The teeth 1049 are configured to engage the tension wire 1016 under the biasing force of the spring 70. When the slide block 1033 is moved in direction D (see FIG. 38), the jaw 1045 engages and grips the tension wire 1016 and pulls the tension wire in direction D.

  For example, if it is desired to return the outer tube 1002 to a flexible state, the slide block 1033 is driven and moved in the direction U as described above to disengage the teeth 1049 from the tension wire 1016. As the slide block 1033 is moved further toward the restriction block 1036 and the wire lock release 1031, the wire lock release 1031 extends into the tapered conical hole 1047 and pushes the jaw 1045 backward against the bias of the spring 70. . Once tension wire 1016 is released from jaw 1045, outer tube 1002 returns to its most flexible state.

  35-39, device 1000 has been described as having a flexible state and a rigid state. However, it should be understood that optionally device 1000 may have one or more intermediate states in which outer tube 1002 is only partially flexible or only partially rigid. . In addition, optionally, the outer tube 1002 has one or more portions that differ in rigidity or flexibility from one or more other portions of the outer tube in a flexible state and / or a rigid state. May be. For example, when the outer tube transitions to a rigid state, at least one portion of the outer tube may remain flexible. Alternatively, when the outer tube is placed in a rigid state, at least one portion of the outer tube may have a different stiffness compared to other portions of the outer tube. As yet another alternative, when the outer tube is placed in a flexible state, at least one portion of the outer tube may have a different flexibility than other portions of the outer tube. Additional configurations will be apparent to those skilled in the art.

  For example, prior to securing the outer tube in the desired orientation, the device 1000 may optionally have steering capability in addition to fixation capability to properly position the device 1000 within the GI lumen. Should be understood. Such steering capability can be achieved, for example, using wire pulling or stiffening which is known per se. Other steering techniques will be apparent to those skilled in the art.

  In addition to, or as an alternative to, advancement of diagnostic and / or therapeutic instruments through one or more lumens of the apparatus 1000, such instruments can optionally be connected to the apparatus 1000. For example, an endoscope, tissue grasping assembly, plication device, and / or anchor delivery system according to the present invention can be connected to the distal region 1003 of the device 1000. Alternatively, such an instrument can be pivotably disposed within the distal region 1003 and advanced therefrom. The connection of an instrument or tool to a shape-lockable guide is described in further detail in US patent application Ser. No. 10 / 458,060, filed Jun. 9, 2003, filed concurrently with this application. This application claims priority from this application, the entire application of which is hereby incorporated by reference herein. Additional configurations will be apparent to those skilled in the art.

  Reference is now made to FIG. 40 in combination with FIG. 41, and as an example, a commercially available gastroscope 1100, the plication device 10 of FIGS. 1-3, the anchor delivery system 250 of FIG. 21 loaded with the anchor assembly 60 of FIG. And a method of performing endoscopic gastric reduction using a tool system having the shape fixable device 1000 of FIGS. Stomach reduction is a technique for reducing a patient's appetite and / or food intake capacity by reducing the volume of the stomach through which food can pass. Endoscopic gastric reduction according to the present invention involves compartmentalization of the stomach into first and second chambers, and more specifically, into a large chamber spanning a small lumen or pouch and at least a portion of the stomach. With parcels.

Lumen / sachet is preferably has a volume of about 10 to 50 cm ^3, more preferably have a volume of about 15cm ^3, positioned near and below the connection portion of the patient's stomach and esophagus. Ingested food can only pass through this small lumen beyond the compartment of the stomach. This lumen is preferably formed by approximating the opposing anterior and posterior segments of the patient's stomach wall near the stomach and esophagus junction and over the length or arc of the wall below.

  As shown in FIGS. 40 and 41, endoscopic gastric reduction involves endoscopically forming, approaching, and fixing multiple tissue folds on a first surface inside a patient's stomach. Can then be achieved by endoscopically forming, approximating and securing at least one additional tissue fold to at least one substantially parallel surface within the patient's stomach. The first plurality of tissue folds and the at least one further plurality of tissue folds can be attached to or detached from each other. Each of the plurality of folds preferably comprises one or more tissue folds from opposing anterior and posterior segments of the stomach near and below the stomach-esophageal junction.

  More specifically, endoscopic gastric reduction is advanced through the patient's esophagus into the patient's stomach with the outer tube in a flexible state, and then the outer tube is placed in the desired orientation within the patient's stomach. This can be achieved by transitioning to a rigid state. A fold-forming device that is connected to or advanced through the outer tube can then be used to form multiple tissue folds, while an anchor delivery system is used to bring tissue folds close together and It can be used to fix and / or partition the patient's stomach.

  In FIG. 40, outer tube 1002 of shape fixable device 1000 illustratively has first and second lumens 1005a and 1005b for passing gastroscope 1100 and plication device 10 / anchor delivery system 250, respectively. Yes. In FIG. 40A, an optional thin sheath 2000 is placed in the patient's gastrointestinal lumen through the patient's mouth into the esophagus E and through the stomach-esophagus junction GE into the patient's stomach S. ing. The shape-fixable outer tube 1002 of the device 1000 is advanced through the sheath 2000 to the patient's stomach S while being placed in a flexible state. The sheath 2000 provides a barrier between the outer tube 1002 and the esophagus E, which protects the esophagus during optional torsional rotation, translation, and / or bending of the outer tube 1002; Improvement in the operability of the apparatus 1000 can be promoted.

  In FIG. 40A, by way of example, the gastroscope 1100 is advanced past the distal region 1003 through the lumen 1005a of the outer tube 1002, with the outer tube in a flexible state. As will be apparent to those skilled in the art, as an alternative or in addition, visualization elements can be combined with the outer tube 1002, and by visualizing multiple points, complex procedures can be facilitated, Triangulation may be enabled to place the anchor assembly through the tissue fold. In addition, the plication device 10 and anchor delivery system 250 can be connected to or advanced through the outer tube while the tube is in a flexible state.

  In FIG. 40B, the outer tube 1002 is bent so that the distal region 1003 can be easily engaged with tissue near and below the connection GE between the patient's stomach and esophagus. Such bending can be achieved, for example, by manipulating the steerable distal end 1101 of the gastroscope 1100. Alternatively, the device 1000 may be provided with steering features. As another alternative, a steering tool, such as a profiled wire, can be advanced through the second lumen 1005b to properly orient the outer tube. Still further, the outer tube may have a pre-formed flexible shape that assumes an arcuate configuration, and the rigid wire is removed to straighten the outer tube during delivery through the esophagus E. The tube 1002 can be reversibly placed into the second lumen 1005b. After the distal region 1003 of the device 1000 is placed inside the stomach S, the wire can be removed from the lumen so that the outer tube 1002 again assumes a pre-formed shape. As yet another alternative, the wrinkle forming device 10 and / or the anchor delivery system 250 can be provided with steering features, and these wrinkle forming devices 10 and / or to steer the outer tube into place. Alternatively, anchor delivery system 250 can be advanced through the second lumen.

  With the device 1000 in the desired configuration and orientation, the shape of the device is reversibly fixed to a rigid state as previously described, and the device maintains its position within the stomach. Preferably, the bend of the device 1000 passes through a substantially continuous arc of curvature radius in a fixed shape to reduce the amount of force required to advance and retract the instrument through the outer tube 1002. Make it smaller. In a preferred embodiment, the arc continues for about 270 ° and has a radius of curvature between about 5-10 cm, more preferably about 7-8 cm. By about 270 ° backbend, the distal region 1003 of the device 1000 is directed towards the body of the outer tube 1002 near and below the stomach-esophageal junction GE.

  The plication device 10 and anchor delivery system 250 are advanced through the second lumen 1005b of the outer tube 1002 and distal to the distal region 1003 (or alternatively, the plication device and anchor delivery system are connected to the outer tube. May be). As seen in FIG. 40C, tissue engagement is performed within the stomach S using the tissue grasping assembly 18, for example, under the visualization provided by the gastroscope 1100. For example, a tissue fold F is formed as described above with respect to FIG. Anchor assembly 60 is then placed through the tissue fold by anchor delivery system 250 and adjusted to secure the fold, for example, as described above with respect to FIG.

  As previously described and seen in FIG. 41, in order to achieve endoscopic gastric reduction, the opposing anterior surface An and posterior surface Po of the stomach S may cause the stomach to pass through the first lumen or pouch. Pulled to partition into P and second larger chamber C. As seen in FIG. 41C, in order to realize such a partition, a plurality of wrinkles are formed on the opposing surfaces in the first surface P1. Opposing folds are connected by suture 39 or other means and brought closer together, for example by shortening the length of the suture located between the opposing surfaces, and the stomach is partitioned as shown in FIG. 41B.

  Optionally, at least one further plurality of ridges may be formed on the opposing front surface An and rear surface Po in at least one further surface substantially parallel to the first surface P1. Figures 40D and 41C include additional tissue folds optionally on the second and third faces P2 and P3. In fact, an anterior ridge AR made of tissue folds and an opposing posterior ridge PR made of tissue folds are formed. These additional tissue folds may or may not be attached to the first plurality of tissue folds as shown in FIG. 41C. When the tissue fold is approached, for example, by tightening the suture 39, a pouch P is formed and endoscopic gastric reduction is achieved.

The number of surfaces on which the multiple tissue folds are formed can be specified based on the preferred longitudinal spacing of the anchor assembly and / or based on the desired length of the pouch P. The desired length L can be specified according to the following formula based on the desired volume V of the pouch P and the diameter D of the pouch P.
L = 4V / (πD ² ) (1)
For example, the outer tube 1002 preferably has an outer diameter of about 1.6 cm. Therefore, the diameter of the pouch P must be at least 1.6 cm so that the outer tube can pass through the pouch. Given that the diameter of the pouch is about 1.6 cm, the length of the pouch P must be about 7.5 cm to yield a pouch with a volume of about 15 cm ³ .

  Referring again to FIG. 40C, the outer tube 1002 preferably has multiple degrees of freedom to form, secure, and approximate tissue folds on the opposing anterior surface An and posterior surface Po of the stomach S in multiple planes P. Have. The arrows in FIG. 40C show examples of directions in which the device 1000 can be steered to change the direction or configuration of the outer tube 1002. Specifically, the device 1000 can be translated relative to the esophagus E and the sheath 2000 as indicated by the arrow Tr. Furthermore, the device 1000 can be twisted and rotated as indicated by the arrow To. Still further, the device 1000 can be bent as indicated by the arrow ARt. Of course, further or other degrees of freedom can optionally be provided.

  As an example, translation or torsional rotation of the outer tube 1002 can be achieved by the physician translating or twisting the handle 1001 of the device 1000 from outside the patient. Bending can be achieved by several means, such as a steering feature such as a pull wire provided in the outer tube 1002, or the outer tube 1002 can be temporarily returned to a flexible state to This can be accomplished by manipulating the steerable end 1101 to bend the outer tube 1002 to the desired configuration and then re-fix the shape of the outer tube 1002 to a rigid state. A combination of torsional rotation, translation, and bending can be used to position the outer tube 1002 into any desired configuration.

  40D, the outer tube 1002 is repositioned, the anchor delivery system 250 is reloaded, and the plication device 10 and the anchor delivery system 250 are operated again to provide tissue folds on opposing surfaces. Is formed, fixed, and brought close to each other, thereby forming a sachet P and a chamber C in the stomach S. The outer tube 1002 has transitioned to its original flexible state, and all instruments that have been advanced through the outer tube have been removed from the device 1000. The outer tube 1002 and optional sheath 2000 can now be removed from the stomach S and esophagus E through the pouch P, completing the endoscopic stomach reduction.

  42, a method for treating gastroesophageal reflux disease (“GERD”) using the tool system described with respect to FIG. 40 is presented. The device 1000 is advanced through the patient's esophagus E with the outer tube 1002 in a flexible state. Again, an optional sheath 2000 can be provided between the esophagus E and the device 1000. The device is then manipulated, for example, as described above, to a configuration that allows access to tissue in the vicinity of the patient's stomach and esophagus connection GE. Then, as seen in FIG. 42A, the shape of the outer tube 1002 is fixed in a rigid state.

In Figure 42B, plication device 10 (advanced through device 1000, or is connected to the device 1000) it is, to form a fold F ₁ of the tissue on a first side of the connecting portion GE the stomach and the esophagus using Is done. Anchor assembly 60 is positioned and adjusted by anchor delivery system 250 to secure the tissue fold. Visualization of this treatment is realized by a gastroscope 1100, for example.

This tissue fold F ₁ provides a flap that reduces backflow of acid or other gastric material into the esophagus E. In more severe patients, it may be necessary to provide one or more additional folds near the connection GE between the stomach and the esophagus. For example, the device 1000 can be repositioned and reloaded with the anchor delivery system 250 to form the opposing heel F ₂ as shown in FIG. 42C. After the desired pressure differential is established across the connection GE between the stomach and the esophagus, the outer tube 1002 is returned to a flexible state and is advanced through the device 1000 as well as any device connected to the device 1000. The instrument can be removed from the patient, thus providing endoscopic treatment of gastroesophageal reflux disease. Optionally, first and second pressure sensors Fri and Pr2 may be provided along the length of the device 1000 as seen in FIG. 42B to measure the pressure difference across the connection GE between the stomach and the esophagus. Good. In use, the first pressure sensor Fri can be placed in the stomach S of the patient distal to the connection, and the second pressure sensor Pr2 can be placed in the patient's esophagus E proximal to the connection. Additional or alternative sensors will be apparent to those skilled in the art.

  Next, another method for realizing endoscopic reduction or shaping of the stomach will be described with reference to FIG. Biomedics (R) LAP-BAND (R) System is marketed by Inamed Corporation of Santa Barbara, California, which consists of an inflatable silicone band placed on the patient's abdomen by a laparoscope Yes. This band is secured around the upper part of the stomach, giving the stomach an hourglass-like constricted shape, creating a small stomach sachet that limits and manages the amount of food a patient can consume. It also creates a small outlet that slows the discharge process to the stomach and small intestine. According to the company's website, patients using this system feel full earlier and are satisfied with a small amount of food, which results in weight loss.

  A major disadvantage of BioEnterics® LAP-BAND® System is that a laparoscopic incision must be made in the patient's abdomen in order to place the device. US patent application Ser. No. 10 / 288,619 of the present applicant, pending at the same time as the present application, is an endoscopic device for providing an hourglass-shaped constricted shape in the stomach to promote weight loss. The method and apparatus are described, reducing the need for laparoscopic incisions, and this application claims priority from this application, the entire application of which is hereby incorporated by reference herein. Shall be. In FIG. 43, the tool system of the present invention is used to endoscopically achieve such gastric reduction and shaping with tissue folds. In the method of FIG. 43, only the suture is placed outside the stomach after the reduction / shaping.

  In FIG. 43A, multiple tissue folds F include a plication device 10, multiple anchor assemblies 60 connected together by sutures 39, multiple firing anchor delivery system 500, shape fixable device 1000, and gastroscope 1100. Is formed around the stomach S in the upper part of the stomach. In FIG. 43B, the interconnected anchor assemblies are tightened together to bring the tissue folds F close together, resulting in an endoscopically shaped, hourglass-like constriction in the stomach S. The tool system is then removed from the patient and the endoscopic stomach S reduction or shaping is complete.

  40-42, instead of using the anchor delivery system 250 of FIG. 21, the anchor delivery systems 500, 500 ′, or 600 of FIGS. 25-27 (eg, several anchor assemblies 60 of FIG. 7 are loaded). Multiple firing anchor delivery systems can be used, such as penetrating one or more tissue folds without the need to remove and reload all or part of the anchor delivery system from the patient's GI lumen Multiple anchor assemblies can be placed and secured. The method of FIGS. 40-43 has also been illustrated with respect to a tool system comprising plication device 10, anchor assembly 60, anchor delivery system 250 (delivery system 500 of FIG. 43), shape fixable device 1000, and gastroscope 1100. However, any combination of diagnostic or therapeutic tools / instruments according to the present invention may be utilized, such as other wrinkle forming devices, anchor assemblies, anchor delivery systems, and shape fixable devices already described. Still further, the visualization elements shown in FIGS. 40-43 include, but are not limited to, endoscopes or gastroscopes, magnetic resonance imaging, ultrasound imaging, optical coherence tomography imaging, It should be understood that any other method or device for visualizing medical procedures may be provided as an alternative or in addition, such as fluorescence imaging and combinations thereof. Further, although the tool system has been illustrated as being advanced through the shape fixable device 1000, alternatively or in addition, some or all of these tools can be connected to the device 1000, for example in the distal region 1003 of the device 1000. It should be understood that this may be done.

  Figures 40-43 present a method of using the device of the present invention to perform endoscopically gastric reduction and GERD treatment. Other methods for performing these surgeries using the apparatus of the present invention will be apparent to those skilled in the art. For example, Silvermann et al., US Pat. No. 6,540,789, incorporated herein by reference, injects filler into the patient's stomach at multiple locations, Describes a method for performing gastric reduction by reducing the volume. The device of the present invention can be used to reduce the volume of a patient's stomach by forming and securing multiple folds in the patient's stomach. The tissue folds can be formed, for example, at a plurality of randomly selected locations. Alternatively, the device of the present invention can be used to perform gastric reduction by placement and / or dimensional adjustment of an implantable stoma in the stomach. As yet another example, the device of the present invention may be equipped with a marking device to illustrate the location for forming a tissue fold, for example to achieve gastric reduction. Further methods are also apparent.

  The device of the present invention should in no way be construed as limited to the treatment of GERD or obesity. Rather, using the tools and instruments of the present invention, various other medical procedures related to both diagnosis and treatment, or combinations thereof, are hollow, winding, and / or unpredictably supported. Can be performed in the patient's gastrointestinal lumen or other body cavities or organs, such as body cavities. These include, but are not limited to, endoscopic retrograde cholangiopancreatography (“ERCP”), intubation into the bile duct, endoscopy of the upper or lower gastrointestinal tract, colonoscopy, Flexible sigmoidoscopy, esophageal dilation, anastomosis, liver biopsy, esophageal manometry, esophageal pH, cholecystectomy, enteroscopic surgery, removal of lesions or early cancer, treatment of bleeding sites, transesophageal micro Surgery, transanal microsurgery, and combinations thereof. Further treatments will be apparent to those skilled in the art.

  Referring to FIG. 44, an exemplary method of using the apparatus of the present invention to remove a lesion or early cancer, for example, in a patient's gastrointestinal tract will be described. In FIG. 44, the tool system 3000 has an outer tube 1000 capable of fixing the shape, and a suction type fold former 1500 is connected to the distal end of the outer tube 1000. The system 3000 further includes an endoscope 1100 and a tool delivery tube 1600 disposed within the lumen 1005 of the outer tube 1000. The tool delivery tube 1600 can optionally have a delivery tube 252 of an anchor delivery system 250 as described below with respect to FIG. 45, or can have a delivery tube of any other anchor delivery system already described. Further, the tube 1600 can be connected to the outer tube 1000 or can be advanced relative to the outer tube.

  The suction-type wrinkle former 1500 has a lateral opening 1510 to facilitate the formation of tissue wrinkles by lateral suction. Additionally or alternatively, the plication device 1500 may have one or more openings (not shown) at the distal end to facilitate the formation of tissue plications by suction at the ends. Good. The heel former 1500 and outer tube 1000 can be inhaled through the outer tube and heel former by a suction pump (not shown) connected to the proximal region of the outer tube 1000 outside the patient. Sealed over their length.

  Conveniently, the outer tube 1000, which can be fixed in shape as compared to the already known suction plication devices, allows the tool system 3000 to be moved to the treatment site while placing the outer tube in a flexible normal state. Allow placement. Then, optionally, the outer tube 1000 can be transitioned to a rigid state prior to suction by the heel former 1500. In this way, the system 3000 can be guided to and maintained at the treatment site in a medical procedure.

  In FIG. 44, an outer tube 1000, which can be fixed in shape, is placed under the endoscopic visualization provided by endoscope 1100, for example, the patient's esophagus or colon, with the outer tube in a flexible state. Through to the lesion along the wall W of the tissue or the vicinity of the initial cancer C. Alternatively, the outer tube 1000 may be advanced laparoscopically, for example through a trocar. The outer tube is then transferred to a rigid state, preferably in a configuration that allows access to the lesion or early cancer, such as luminal access.

  In order to drive tissue in the vicinity of the lesion / early cancer C through the lateral opening 1510 and into the lumen 1005 of the outer tube 1000, suction is performed through the outer tube 1000 and the suction fold former 1500, thereby causing tissue fold F Is formed. As can be confirmed by endoscopic visualization, the lesion or cancer C is located on the fold of the tissue. This lesion, polyp, cancer, etc. can then be removed by a cutting device such as a snare or ablation loop 1700 advanced through delivery tube 1600. As will be apparent to those skilled in the art, other plication devices according to the present invention can also be used to excise lesion C.

  With reference to FIG. 45, an exemplary method for endoscopically treating a bleeding site, for example, in the gastrointestinal tract of a patient will be described. In FIG. 45, the tool system 3000 ′ includes a delivery tube 252 of an anchor delivery system 250, for example, a tool delivery tube 1600 ′, and an ablation loop 1700, for example, through a lateral opening 1510 of a suction fold former 1500. 44 is substantially identical to the system 3000 of FIG. 44 except that it has been replaced with an anchor delivery system 250 and anchor assembly 60 for securing the retracted tissue fold. Using the technique described above with respect to FIG. 44, the system 3000 'is placed and the tissue fold F is formed such that the bleeding site B is located on top of the tissue fold F. The anchor delivery system 250 with the needle 260 is then moved in the manner previously described to position and adjust the anchor assembly 60 to secure the tissue fold F and seal and prevent further bleeding from the bleeding site B. To do.

  As will be apparent to those skilled in the art, other plication devices and / or anchor delivery systems according to the present invention can also be used to treat bleeding site B. Furthermore, although the tool systems 3000 and 3000 ′ of FIGS. 44 and 45, respectively, have been illustrated as being used for lesion resection and / or treatment of bleeding sites, these systems may alternatively or additionally be It can be used for any other applicable medical procedure such as, but not limited to, the previously described procedures such as gastric reduction and treatment of gastroesophageal reflux disease.

  As mentioned above, although preferred embodiment of this invention was illustrated and demonstrated, it is clear for those skilled in the art that various changes and deformation | transformation are possible about them without leaving this invention. The appended claims are intended to cover all such changes and modifications as fall within the true spirit and scope of the invention.

1A and 1B are side and detail views, respectively, of a device of the present invention for forming a gastrointestinal fold according to the principles of the present invention. 2A and 2B are side cross-sectional views of a tissue grasping assembly suitable for use in the apparatus of FIG. 3A-3E are side views illustrating a method of using the apparatus of FIG. 1 to form a gastrointestinal fold. 4A-4C are side cross-sectional views of an anchor assembly and anchor delivery system suitable for use in the device of the present invention. 5A and 5B are side cross-sectional views of other anchor assemblies suitable for use in the apparatus of the present invention. 6A and 6B are side cross-sectional views of yet another anchor assembly suitable for use in the apparatus of the present invention. 7A-7C are schematic side cross-sectional views, respectively, of a unidirectionally adjustable anchor assembly suitable for use in the device of the present invention, and a schematic of other techniques for securing the distal anchor of the assembly. FIG. 7B is a side cross-sectional view and a cross-sectional view of the proximal anchor taken along section line AA of FIG. 7A. 8A and 8B are schematic cross-sectional views illustrating the unidirectional adjustment capability of the anchor assembly of FIG. 9A-9C are schematic cross-sectional views of other embodiments of the proximal anchor of the anchor assembly of FIG. 10A and 10B are schematic cross-sectional views of another one-way adjustable anchor assembly suitable for use in the apparatus of the present invention. FIGS. 11A-11C are each a schematic side view of a further one-way adjustable anchor assembly suitable for use in the present invention, and for that, along the section line BB of FIG. 11A It is the obtained sectional view. FIG. 12 is a schematic cross-sectional view of another one-way adjustable anchor assembly with a pivoting paddle. FIG. 13 is a schematic cross-sectional view of another one-way adjustable anchor assembly with spring material. 14A and 14B are schematic side cross-sectional views of another one-way adjustable anchor assembly with a one-way valve. 15A-15C are schematic side cross-sectional and detail views of another one-way adjustable anchor assembly with a knot. 16A-16C are schematic side cross-sectional views of a bi-directionally adjustable anchor assembly with a locking mechanism, respectively, and a cross-sectional view taken along section line CC of FIG. 16A for it. . 17A-17D are perspective views of other anchors suitable for use in the anchor assembly of the present invention. 18A-18D are side views of other devices for forming a gastrointestinal fold. FIG. 19 is a cross-sectional view of the device of FIGS. 20A-20D are side views of yet another device for forming a gastrointestinal tissue fold according to the principles of the present invention. 21A-21G are schematic side cross-sectional views of an anchor delivery system configured to be used with the adjustable anchor assembly of FIGS. 7-17, with the unidirectional adjustable anchor assembly of FIG. Describes how to deliver across tissue folds. 22A and 22B are schematic partial cross-sectional side and end views, respectively, of another anchor delivery system configured to be used with the adjustable anchor assembly of FIGS. Is placed inside the delivery tube. FIG. 23 is a schematic side cross-sectional view of another anchor delivery system configured to be used with the adjustable anchor assembly of FIGS. 7-17, where both the proximal anchor and the distal anchor are inside the needle. Is loaded. FIG. 24 is a schematic side cross-sectional view of another embodiment of the anchor delivery system of FIG. 23 having a motion limiting device. FIG. 25 is a schematic partial cross-sectional side view of another anchor delivery system configured to deliver multiple anchor assemblies. FIG. 26 is a schematic side view of another embodiment of the anchor delivery system of FIG. 27A and 27B are schematic isometric and partial cross-sectional side views, respectively, of another anchor delivery system configured to deliver multiple anchor assemblies by a revolver. FIGS. 28A and 28B are side views of another embodiment of the device of FIG. 20 illustrating a method for simultaneously forming and approximating multiple folds of gastrointestinal tissue. FIG. 29 is an isometric view of another embodiment of the apparatus of FIG. 1 for forming a gastrointestinal tissue fold with dorsal stabilization. 30A-30E are partial cross-sectional side and isometric views illustrating a method of using the apparatus of FIG. 29 to form a gastrointestinal tissue fold with a stabilized back surface. 31A to 31C are side views of still another tissue wrinkle forming apparatus, which illustrate a method for forming a wrinkle of gastrointestinal tissue by linearly displacing the tissue. FIG. 32 is a side view of another embodiment of the apparatus of FIG. 31 that provides additional flexibility. FIGS. 33A and 33B are side views of yet another linear displacement plication device with front and back stabilization, illustrating a method of forming gastrointestinal tissue folds. Figures 34A and 34B are a side view and partial cross-sectional side view, respectively, of yet another alternative device, illustrating a method for forming a gastrointestinal tissue fold stabilized by a knitted mesh. FIG. 35 is a side view of an example of a shape fixable device for use with the tissue fistula formation device and anchor delivery system of the present invention. 36 is a side cross-sectional exploded view of the nestable member of the first embodiment of the outer tube suitable for use in the shape fixable device of FIG. 37 is a side cross-sectional view of the distal region of the apparatus of FIG. 35 constructed in accordance with the principles of the present invention. FIG. 38 is a side cross-sectional view of an example arrangement of mechanisms suitable for use in the handle of the apparatus of FIG. FIG. 39 is a side cross-sectional view of details of a wire restraint system suitable for use in the handle of FIG. 40A-40D are illustrated by tool systems including, for example, the shape fixable device of FIGS. 35-39, the plication device of FIGS. 1-3, the anchor assembly of FIG. 7, the anchor delivery system of FIG. 21, and a commercially available gastroscope. 1 is a partial cross-sectional side view showing an exemplary method for performing endoscopic gastric reduction. FIG. 41A-41C are each an isometric view of a patient's stomach after performing endoscopic gastric reduction using the method of FIG. 40, along plane AA of FIG. 41A for it. FIG. 41B is a cross-sectional view of the stomach along the plane BB of FIG. 41A before approaching multiple tissue folds to achieve gastric reduction. 42A-42C are partial cross-sectional side views illustrating an exemplary method of treating gastroesophageal reflux disease with the tool system illustrated with respect to FIG. 43A and 43B are partial cross-sectional side views illustrating another method of performing endoscopic gastric reduction utilizing the tool system of the present invention. FIG. 44 is a partial cross-sectional side view illustrating a method of resecting a lesion or early cancer using the tool system of the present invention having, for example, a suction applicator and an ablation loop. FIG. 45 is a partial cross-sectional side view illustrating a method of treating a bleeding site using the tool system of the present invention.

Claims (55)

An apparatus for forming a tissue fold on a tissue wall of a hollow body cavity of a patient,
A catheter having a flexible tube, the distal region of the flexible tube being configured to be inserted into the body cavity;
A tissue engaging assembly disposed in the distal region and defining a first tissue contact point;
A second tissue contact point initially located at a location proximal to or adjacent to the first tissue contact point, and the first tissue contact point An apparatus having a tissue proximity device that is moved to a position proximal to the second tissue contact point to form a tissue fold. A third tissue contact point initially located at a position proximal to or adjacent to the first tissue contact point;
The tissue proximity device places the first tissue contact point in the vicinity of the third tissue contact point so that the second tissue contact point and the third tissue contact point are located on both sides of the tissue fold. The device of claim 1, wherein the device is moved to a distal position to form a tissue fold. The apparatus of claim 3, wherein the tissue proximity device linearly displaces the first tissue contact point relative to the second tissue contact point and the third tissue contact point. The apparatus of claim 1, further comprising an anchor delivery system configured to deliver an anchor assembly to secure the tissue fold with the anchor assembly. The apparatus of claim 4, wherein the anchor delivery system comprises a flexible delivery catheter configured to be inserted into the body cavity. 6. The device of claim 5, wherein the flexible delivery catheter is configured to bend to align in a direction across the tissue fold. The apparatus of claim 6, wherein the anchor delivery system further comprises a needle configured to be advanced through the flexible delivery catheter and pass across the tissue fold. The apparatus of claim 7, wherein the anchor assembly is configured to be delivered through the needle. The apparatus of claim 1, wherein the tissue engaging assembly is configured to engage a mucosa to define the first tissue contact point. The apparatus of claim 1, wherein the tissue engagement assembly is configured to engage a muscle layer to define the first tissue contact point. The apparatus of claim 1, wherein the tissue engagement assembly is configured to engage a serosa to define the first tissue contact point. 5. The tissue fold has serosal and serosal tissue contact, and the anchor assembly is configured to secure the serosal and serosal tissue contact. apparatus. The apparatus according to claim 1, further comprising a guide tube capable of fixing a shape. A method for forming a tissue fold on a tissue wall of a hollow body cavity of a patient comprising:
Endoscopically capturing the tissue wall at the first tissue contact point;
Endoscopically contacting the tissue wall at a second tissue contact point; andthe first tissue contact point is distal to the second tissue contact point or the second Moving from an initial position alongside the two tissue contact points to a position proximal to the second tissue contact point to form a tissue fold. 15. The method of claim 14, wherein moving the first tissue contact point includes linearly displacing the first tissue contact point with respect to the second tissue contact point. Endoscopically contacting the tissue wall at a third tissue contact point; and the second tissue contact point and the third tissue contact point are located on opposite sides of the tissue fold. As such, from a first position that is distal to or aligned with the third tissue contact point, the first tissue contact point and the third tissue contact point are The method of claim 14, further comprising moving to a location proximal to the tissue contact point. The tissue fold includes serosal and serosal tissue folds;
15. The method of claim 14, wherein the method further comprises fixing the serosal and serosal tissue folds. 18. The method of claim 17, wherein securing the serosal serosal tissue fold further comprises positioning a needle laterally through the tissue fold. The method of claim 18, wherein securing the serosal serosal tissue fold further comprises extending an anchor assembly from the inside of the needle. Placing the needle laterally through the tissue fold,
20. The method of claim 19, further comprising: advancing the needle through a delivery catheter; and bending the delivery catheter to align in a direction across the tissue fold. 15. The method of claim 14, further comprising forming at least one additional tissue fold in the hollow body cavity. A system for endoscopically forming a tissue fold within a hollow body organ,
An endoscopic device having a proximal end, a distal end, and an elongated portion between the proximal end and the distal end;
A tissue engaging mechanism configured to project from the distal end of the endoscopic device and capture tissue within the hollow body organ, and the tissue engagement within the hollow body organ A system having an anchor delivery system that can be positioned proximate to the mating mechanism and configured to endoscopically extend the anchor assembly through the captured tissue. 23. The imaging device of claim 22, further comprising a bendable imaging device that protrudes from the distal end of the endoscopic device and bends off an axis of the endoscopic device. system. 24. The system of claim 23, wherein the imaging device includes a gastroscope. 24. The system of claim 23, further wherein the imaging device is configured to allow visual triangulation when bent off axis. The length portion of the endoscope apparatus is configured by a cylindrical member capable of fixing the shape, and the member is configured to fix the arrangement configuration inside the hollow body organ. The system of claim 22. 23. The system of claim 22, wherein the endoscopic device defines a plurality of working lumens that penetrate the endoscopic device. 24. The system of claim 22, wherein the tissue engaging mechanism comprises a tissue grasper. 24. The system of claim 22, wherein the tissue engagement mechanism is configured to capture and move the tissue proximally relative to the endoscopic device. 24. The system of claim 22, wherein the anchor delivery system comprises a flexible delivery tube. 32. The system of claim 30, wherein a portion of the flexible delivery tube is configured to be redirected to align in a transverse direction with respect to the captured tissue. The anchor delivery system further comprises a needle;
32. The system of claim 30, wherein the needle is configured to be advanced through the flexible delivery tube and pass across the captured tissue. 35. The system of claim 32, wherein the anchor delivery system is configured for delivery through the needle. A method for performing a medical procedure inside a hollow body organ of a body structure that is winding or unpredictably supported,
Advancing the outer tube in a flexible state within the hollow body organ;
Transitioning the outer tube to a rigid state in any desired configuration;
Advancing a plication device through the outer tube, and forming a tissue fold with the plication device within the hollow body organ. 35. The method of claim 34, further comprising visualizing the formation of the tissue fold. 36. The method of claim 35, wherein visualizing formation of the tissue fold further comprises visualizing formation by a visualization element advanced through the outer tube. 36. The method of claim 35, wherein visualizing formation of the tissue fold further comprises visualizing formation by a visualization element connected to the outer tube. The medical procedure includes endoscopic treatment of gastroesophageal reflux disease;
Advancing the outer tube within a hollow body organ includes advancing the outer tube through the patient's esophagus and into the patient's stomach;
Transitioning the outer tube to a rigid state includes transitioning the outer tube to a rigid state in an arrangement that allows access to a connection between the patient's stomach and esophagus. And
35. The method of claim 34, wherein forming the tissue fold comprises forming at least one tissue fold in the vicinity of the patient's stomach-esophageal connection. The medical procedure includes endoscopic implementation of gastric reduction;
Advancing the outer tube within a hollow body organ includes advancing the outer tube through the patient's esophagus and into the patient's stomach;
Transitioning the outer tube to a rigid state includes transitioning the outer tube to a rigid state in a desired configuration within the stomach of the patient;
35. The method of claim 34, wherein forming the tissue fold comprises forming a plurality of tissue folds within the patient's stomach. 40. The method of claim 39 further comprising the step of approaching and securing the plurality of tissue folds to partition the patient's stomach into at least a first chamber and a second chamber for at least a portion of the stomach. The method described. Forming, approaching and fixing multiple tissue folds,
Forming, approximating and fixing a first plurality of tissue folds on a first side; and forming, approximating and fixing at least one further plurality of tissue folds on at least one further side. Further comprising the steps of:
40. The method of claim 39, wherein the first surface and the at least one additional surface are substantially parallel to each other. 41. The method of claim 40, wherein partitioning the stomach into a first chamber and a second chamber further comprises partitioning the stomach into a first lumen and a second chamber. . Partitioning the stomach into a first lumen and a second chamber includes partitioning the stomach such that a connection between the patient's stomach and esophagus communicates only with the first lumen; 43. The method of claim 42, further comprising. Step includes the step of partitioning into first lumen having a volume in the range of 10 to 50 cm ³ of該胃The method of claim 43 for partitioning and the stomach into the first lumen . 40. The method of claim 39, wherein forming a plurality of tissue folds further comprises forming a plurality of tissue folds below a connection between the patient's stomach and esophagus. The step of forming a plurality of tissue folds includes at least one tissue fold from an anterior segment of the patient's stomach and at least one tissue fold from an opposing posterior segment of the patient's stomach. 46. The method of claim 45, further comprising forming a plurality of tissue folds. Forming a plurality of tissue folds within a patient's stomach forming and securing a plurality of tissue folds disposed in a substantially randomly selected location to reduce the volume of the stomach; 40. The method of claim 39, comprising: Forming a plurality of tissue folds within a patient's stomach through a plurality of tissues interconnected around the patient's stomach by an instrument advanced through the outer tube or an instrument connected to the outer tube Including the step of forming
40. The method of claim 39, further comprising the step of approximating the interconnected tissue folds to shape the stomach into an hourglass constricted shape. The medical procedure includes excision of a lesion or cancer in the patient's gastrointestinal tract;
Advancing the outer tube within a hollow body organ includes advancing the outer tube through the patient's esophagus or colon;
Transitioning the outer tube to a rigid state includes transitioning the outer tube to a rigid state in an arrangement that allows access to the lesion or cancer;
The step of forming a tissue fold is at least one such that the lesion or cancer is located on the fold of the tissue by a plication device that is advanced through the outer tube or a plication device connected to the outer tube. 35. The method of claim 34, comprising forming a tissue fold. 50. The method of claim 49, further comprising removing the lesion or cancer. 51. The method of claim 50, wherein removing the lesion or cancer further comprises removing the lesion or cancer with a cutting device. 52. The method of claim 51, wherein removing the lesion or cancer with a cutting device further comprises removing the lesion or cancer with a snare. The medical procedure includes endoscopic treatment of a bleeding site in the patient's gastrointestinal tract;
Advancing the outer tube within a hollow body organ includes advancing the outer tube through the patient's esophagus or colon;
Transitioning the outer tube to a rigid state includes transitioning the outer tube to a rigid state in an arrangement that allows access to the bleeding site;
The step of forming a tissue fold is performed by a plication device that is advanced through the outer tube or a plication device connected to the outer tube so that the bleeding site is located on the tissue fold. 35. The method of claim 34, comprising forming a ridge. 54. The method of claim 53, further comprising reducing bleeding from the bleeding site by fixing the tissue fold. 55. The method of claim 54, wherein securing the tissue fold further comprises securing the tissue fold with an anchor assembly.

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