Patent Publication Number: US-11045341-B2

Title: Apparatus for manipulating and securing tissue

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     The present application is a Continuation of U.S. patent application Ser. No. 15/349,127, filed Nov. 11, 2016, and now U.S. Pat. No. 10,045,871, which is a Continuation of U.S. patent application Ser. No. 13/491,273, filed Jun. 7, 2012, and now U.S. Pat. No. 9,510,817, which is a Continuation of U.S. patent application Ser. No. 12/107,701, filed Apr. 22, 2008, and now U.S. Pat. No. 8,216,253, which is a Continuation of U.S. patent application Ser. No. 10/954,666, filed Sep. 29, 2004, now U.S. Pat. No. 7,361,180, which is a Continuation-in-part of U.S. patent application Ser. No. 10/840,950, filed May 7, 2004, now U.S. Pat. No. 8,308,765. This application is related to the following U.S. patent application Ser. No. 10/735,030 filed Dec. 12, 2003, now U.S. Pat. No. 8,574,243; Ser. No. 10/955,245 filed Sep. 29, 2004, now U.S. Pat. No. 7,347,863; Ser. No. 10/956,009 filed Sep. 29, 2004, now abandoned; Ser. No. 10/955,243 filed Sep. 30, 2004, now U.S. Pat. No. 7,621,925; and Ser. No. 10/955,244 filed Sep. 30, 2004, now U.S. Pat. No. 7,601,159, the contents of which are incorporated herein by reference in their entirety. 
    
    
     BACKGROUND OF THE INVENTION 
     The present invention relates to methods and apparatus for forming and securing gastrointestinal (“GI”) tissue folds. More particularly, the present invention relates to methods and apparatus for reducing the effective cross-sectional area of a gastrointestinal lumen. 
     Morbid obesity is a serious medical condition pervasive in the United States and other countries. Its complications include hypertension, diabetes, coronary artery disease, stroke, congestive heart failure, multiple orthopedic problems and pulmonary insufficiency with markedly decreased life expectancy. 
     A number of surgical techniques have been developed to treat morbid obesity, e.g., bypassing an absorptive surface of the small intestine, or reducing the stomach size. However, many conventional surgical procedures may present numerous life-threatening post-operative complications, and may cause atypical diarrhea, electrolytic imbalance, unpredictable weight loss and reflux of nutritious chyme proximal to the site of the anastomosis. 
     Furthermore, the sutures or staples that are often used in these surgical procedures typically require extensive training by the clinician to achieve competent use, and may concentrate significant force over a small surface area of the tissue, thereby potentially causing the suture or staple to tear through the tissue. Many of the surgical procedures require regions of tissue within the body to be approximated towards one another and reliably secured. The gastrointestinal lumen includes four tissue layers, wherein the mucosa layer is the inner-most tissue layer followed by connective tissue, the muscularis layer and the serosa layer. 
     One problem with conventional gastrointestinal reduction systems is that the anchors (or staples) should engage at least the muscularis tissue layer in order to provide a proper foundation. In other words, the mucosa and connective tissue layers typically are not strong enough to sustain the tensile loads imposed by normal movement of the stomach wall during ingestion and processing of food. In particular, these layers tend to stretch elastically rather than firmly hold the anchors (or staples) in position, and accordingly, the more rigid muscularis and/or serosa layer should ideally be engaged. This problem of capturing the muscularis or serosa layers becomes particularly acute where it is desired to place an anchor or other apparatus transesophageally rather than intra-operatively, since care must be taken in piercing the tough stomach wall not to inadvertently puncture adjacent tissue or organs. 
     One conventional method for securing anchors within a body lumen to the tissue is to utilize sewing devices to suture the stomach wall into folds. This procedure typically involves advancing a sewing instrument through the working channel of an endoscope and into the stomach and against the stomach wall tissue. The contacted tissue is then typically drawn into the sewing instrument where one or more sutures or tags are implanted to hold the suctioned tissue in a folded condition known as a plication. Another method involves manually creating sutures for securing the plication. 
     One of the problems associated with these types of procedures is the time and number of intubations needed to perform the various procedures endoscopically. Another problem is the time required to complete a plication from the surrounding tissue with the body lumen. In the period of time that a patient is anesthetized, procedures such as for the treatment of morbid obesity or for GERD must be performed to completion. Accordingly, the placement and securement of the tissue plication should ideally be relatively quick and performed with a minimal level of confidence. 
     Another problem with conventional methods involves ensuring that the staple, knotted suture, or clip is secured tightly against the tissue and that the newly created plication will not relax under any slack which may be created by slipping staples, knots, or clips. Other conventional tissue securement devices such as suture anchors, twist ties, crimps, etc. are also often used to prevent sutures from slipping through tissue. However, many of these types of devices are typically large and unsuitable for low-profile delivery through the body, e.g., transesophageally. 
     Moreover, when grasping or clamping onto or upon the layers of tissue with conventional anchors, sutures, staples, clips, etc., may of these devices are configured to be placed only after the tissue has been plicated and not during the actual plication procedure. 
     BRIEF SUMMARY OF THE INVENTION 
     In creating tissue plications, a tissue plication tool having a distal tip may be advanced (transorally, transgastrically, etc.) into the stomach. The tissue may be engaged or grasped and the engaged tissue may be moved to a proximal position relative to the tip of the device, thereby providing a substantially uniform plication of predetermined size. In order to first create the plication within a body lumen of a patient, various methods and devices may be implemented. The anchoring and securement devices may be delivered and positioned via an endoscopic apparatus that engages a tissue wall of the gastrointestinal lumen, creates one or more tissue folds, and disposes one or more of the anchors through the tissue fold(s). The tissue anchor(s) may be disposed through the muscularis and/or serosa layers of the gastrointestinal lumen. 
     One variation of an apparatus which may be used to manipulate tissue and create a tissue fold may generally comprise an elongate tubular member having a proximal end, a distal end, and a length therebetween, an engagement member which is slidably disposed through the tubular member and having a distal end adapted to engage tissue, a first stabilizing member and a second stabilizing member positioned at the tubular member distal end and adapted to stabilize tissue therebetween, wherein the first and second stabilizing members are further adapted to be angled relative to a longitudinal axis of the elongate tubular member, and a delivery tube adapted to pivot about the first stabilizing member. 
     The elongate tubular member or launch tube may be advanced from its proximal end at a handle located outside a patient&#39;s body such that a portion of the launch tube is forced to rotate at a hinge or pivot and reconfigure itself such that the distal portion forms a curved or arcuate shape that positions the launch tube opening perpendicularly relative to a longitudinal axis of body. The launch tube, or at least a portion of the launch tube, is preferably fabricated from a highly flexible material or it may be fabricated, e.g., from Nitinol tubing material which is adapted to flex, e.g., via circumferential slots, to permit bending. 
     The tissue engagement member may be an elongate member, e.g., a wire, hypotube, etc., which has a tissue grasper or engager attached or integrally formed at its distal end for grasping or engaging the tissue. In one variation, the tissue grasper may be formed as a helix having a uniform outer diameter with a constant pitch. The helix  80  may be attached to an elongate acquisition member via any suitable fastening method, e.g., adhesives, solder, etc. Alternatively, the helix may be integrally formed from the distal portion of the acquisition member by winding or coiling the distal portion in a helix configuration. 
     Alternative configurations for the helix may include a number of variations. For instance, the helix may have a varied pitch or one or more regions with varying pitch along the length of the helix. Alternatively, a helix may include a piercing needle extending through the center and protruding distally of the helix. Other variations may include a dual-helix, a helix having a decreasing diameter, the addition of an articulatable grasping jaw in combination with the helix. Moreover, the helix may be completely or partially hollow with one or more deployable anchors positioned within or advanced through hollow helix. 
     Alternative variations for the helix may also include optional measures to prevent the helix from inadvertently damaging any surrounding tissue. For example, one variation may include a sheathed helix assembly while another variation may have an insertion member which defines an atraumatic distal end which may be advanced through the center of the helix. Another alternative may include a helix which may be configured to reconfigure itself into a straightened configuration to facilitate its removal from the tissue. In such a device, the helix may be electrically connected via a connection of wires to a power source. 
     In addition to the variations of the tissue grasper or helix, the stabilizing members, otherwise called extension members, may also include various embodiments. For instance, the upper and/or lower extension members or bails may also be configured with any of the helix variations as practicable. Although the upper and lower extension members or bails may be maintained rigidly relative to one another, the upper and/or lower extension members may be alternatively configured to articulate from a closed to an open configuration or conversely from an open to a closed configuration for facilitating manipulation or stabilization of tissue drawn between the bail members. 
     Articulation or manipulation of the extension members may be accomplished via any number of methods. For instance, the upper and/or lower extension members may include a pivoting cam member, a linkage assembly, biased extension members which are urged closed or open, etc. Moreover, lower extension member may alternatively be extended in length relative to upper extension member or one or both extension members may be configured to have atraumatic blunted ends to prevent inadvertently damaging surrounding tissue. 
     Moreover, it is preferable to have sufficient clearance with respect to the lower extension member so that unhindered deployment of the needle assembly or anchors from the apparatus is facilitated. One method for ensuring unhindered deployment is via a lower extension member having a split opening defined near or at its distal end. Alternatively, the lower extension member may be configured to create a “C”-shaped member which allows for an opening along the member. 
     Alternatively, the lower extension member may be fabricated from a non-conductive material upon which wires may be integrated such that the entire lower member may be electrically conductive to selectively ablate regions of tissue, if so desired. 
     Aside from creating ablation regions, the tissue manipulation assembly may be connected to the tubular body via a hinged or segmented articulatable portion which allows the tissue manipulation assembly to be reconfigured from a low-profile configuration straightened relative to the tubular body to an articulated configuration where the assembly forms an angle relative to the tubular body. The articulatable portion may be configured to allow the assembly to become articulated in a single plane or it may also be configured to allow a full range of motion unconstrained to a single plane relative to tubular body to facilitate manipulation of the tissue. 
     In addition to the extension members, the launch tube itself may be fabricated from a metal such as Nitinol, stainless steel, titanium, etc., to facilitate the flexure of the tube. Such a tube may be selectively scored or cut to enhance the directional flexibility of the tube. 
     The launch tube may be advanced distally until the deployed needle body of the needle assembly emerges from the launch tube perpendicularly to the tissue drawn between the extension members, and particularly to upper extension member. Thus, the distal opening of the launch tube may be configured to form an angle, β, relative generally to the tissue manipulation assembly. The angle, β, is preferably close to 90° but it may range widely depending upon the amount of tissue grasped as well as the angle desired. 
     A distal portion of the launch tube may also be modified to include an extended portion which is configured to remain straight even when the launch tube is flexed into its deployment configuration. This extended portion may provide additional columnar support to a needle body passing through during needle deployment from the launch tube to help ensure the linear deployment of the needle body into or through the tissue. 
     Alternatively, the needle body may define a cross-sectional shape, other than circular, which is keyed to the extended distal portion of the launch tube. The needle body may be keyed to the launch tube to ensure a specified deployment trajectory of the needle body from the keyed launch tube. Alternatively, the launch tube may be overdriven relative to the tissue manipulation assembly and upper extension member. 
     The needle assembly which is advanced through the launch tube may generally comprise the needle body attached or integrally formed with a tubular catheter or push tube. The needle body is preferably a hollow tapered needle which is configured to pierce into and through tissue. The needle body may have a variety or tapered piercing ends to facilitate its entry into tissue. One variation which may be utilized to ensure the needle trajectory through the tissue may include a curvable needle body deployed from the launch tube. Such a needle body may be constrained into a straightened configuration when positioned within the launch tube. However, once deployed the needle body may be adapted to reconfigure itself into a curved configuration directed towards the tissue manipulation assembly. The needle body may be curved via an anvil configured to receive and deflect the travel of the needle body into a curved needle body. 
     Alternatively, the needle body may be replaced with a fiber optic needle which may be deployed through the launch tube to provide visualization of the tissue region prior to, during, or after anchor deployment. In another alternative, advancement of the needle body into and/or through the tissue may be facilitated via an ultrasonic vibrating needle body or a torqueable needle body which may be torqued about its proximal end to facilitate entry into the tissue. The torqueable needle body may be connected via a catheter length having high-torque characteristics. 
     Rather than deploying anchors from the needle assembly via a distal opening in the needle body, the tissue anchor may alternatively be deployed through one or more side openings defined proximally of the distal tip of the needle body. In yet another alternative, the needle body may have gradations or indicators along its surface to provide a visual indication to the surgeon or physician of the position of the needle body when advanced into or through the tissue or when deployed from the launch tube. 
     Moreover, the outer surface of the needle body may be dimpled to enhance the visualization of the needle body within the patient body. Moreover, dimples may also enhance the visualization of needle body under ultrasound imaging. Aside from dimples, the outer surface of the needle body may be coated or covered with a radio-opaque material to further enhance visualization of the needle body. 
     The tissue manipulation assembly may be manipulated and articulated through various mechanisms. One such assembly which integrates each of the functions into a singular unit may comprise a handle assembly which is connected via a tubular body to the tissue manipulation assembly. Such a handle assembly may be configured to separate from the tubular body, thus allowing for reusability of the handle. A tissue manipulation articulation control may also be positioned on the handle to provide for selective articulation of the tissue manipulation assembly. 
     One particular variation of the handle assembly may have handle enclosure formed in a tapered configuration which is generally symmetrically-shaped about a longitudinal axis extending from the distal end to the proximal end of the handle assembly. The symmetric feature may allow for the handle to be easily manipulated by the user regardless of the orientation of the handle enclosure during a tissue manipulation procedure. 
     To articulate the multiple features desirably integrated into a singular handle assembly, e.g., advancement and/or deployment of the launch tube, anchor assembly, needle assembly, articulation of the extension members and tissue manipulation assembly, etc., a specially configured locking mechanism may be located within the handle enclosure. Such a locking mechanism may generally be comprised of an outer sleeve disposed about inner sleeve where the outer sleeve has a diameter which allows for its unhindered rotational and longitudinal movement relative to the inner sleeve. A needle deployment locking control may extend radially from the outer sleeve and protrude externally from the enclosure for manipulation by the user. The outer sleeve may also define a needle assembly travel path along its length. The travel path may define the path through which the needle assembly may traverse in order to be deployed. 
     The needle assembly may define one or more guides protruding from the surface of the assembly which may be configured to traverse within the travel path. The inner sleeve may also define guides protruding from the surface of the inner sleeve for traversal within grooves defined in the handle enclosure. Moreover, the outer sleeve is preferably disposed rotatably about the inner sleeve such that the outer sleeve and inner sleeve are configured to selectively interlock with one another in a corresponding manner when the locking control is manipulated into specified positions. 
     The needle deployment assembly may be deployed through the approximation assembly by introducing the needle deployment assembly into the handle and through the tubular body such that the needle assembly is advanced from the launch tube and into or through approximated tissue. An elongate and flexible sheath or catheter may extend removably from the needle assembly control or housing which may be interconnected via an interlock which may be adapted to allow for the securement as well as the rapid release of the sheath from the housing through any number of fastening methods, e.g., threaded connection, press-fit, releasable pin, etc. The needle-body, which may be configured into any one of the variations described above, may extend from the distal end of the sheath while maintaining communication between the lumen of the sheath and needle opening. 
     An elongate pusher may comprise a flexible wire or hypotube which is translationally disposed within the sheath and movably connected within the housing. A proximally-located actuation member may be rotatably or otherwise connected to the housing to selectively actuate the translational movement of elongate pusher relative to the sheath for deploying the anchors from the needle opening. The anchor assembly may be positioned distally of the elongate pusher within the sheath for deployment from sheath. The housing for the needle deployment assembly may also define all indicator window along its length to provide a visual indicator utilized to indicate the position of the elongate pusher within the sheath. 
     To ensure that the anchor is not prematurely ejected from the needle assembly, various interlocking features or spacing elements may be employed. For instance, adjacent anchors positioned within the needle deployment assembly may be interlocked with one another via a temporary interlocking feature. Likewise, the elongate pusher and an adjacent anchor may be optionally interlocked together as well. Such an interlocking feature may enable the anchor assembly to be advanced distally as well as withdrawn proximally within the sheath and needle body in a controlled manner without the risk of inadvertently pushing one or more anchors out of the needle body. 
    
    
     
       BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS 
         FIG. 1A  shows a side view of one variation of a tissue plication apparatus which may be used to temporarily create tissue plications and to deliver cinching or locking anchors into the tissue. 
         FIGS. 1B and 1C  show detail side and perspective views, respectively, of the tissue approximation assembly of the device of  FIG. 1A . 
         FIG. 2A  is a detail side view of the device shown in  FIGS. 1A-1C  advanced into a body lumen and positioned adjacent to a tissue wall. 
         FIG. 2B  is a detail side view of the device shown in  FIG. 2A  with the tissue grasper engaging the tissue wall. 
         FIG. 2C  is a detail side view of the device shown in  FIGS. 2A and 2B  forming a tissue fold. 
         FIG. 2D  is a detail side view of the device shown in  FIGS. 2A-2C  with the needle assembly piercing the tissue fold. 
         FIG. 3A  shows a cross-sectional side view of an anchor delivery assembly delivering a basket-type anchor into or through a tissue fold. 
         FIG. 3B  shows a cross-sectional side view of multiple tissue folds which may be approximated towards one another and basket anchors as being deliverable through one or both tissue folds. 
         FIG. 4A  shows a side view of one variation for a tissue engaging helix. 
         FIG. 4B  shows a side view of another variation for a helix having a reduced pitch. 
         FIG. 4C  shows a side view of another variation for a helix having a varied pitch. 
         FIG. 4D  shows a side view of another variation for a helix having a piercing needle positioned through the helix. 
         FIG. 4E  shows a side view of another variation having a dual helix. 
         FIG. 4F  shows a side view of another variation for a helix having a decreasing diameter. 
         FIG. 4G  shows a side view of another variation for a helix combined with a grasper. 
         FIGS. 5A and 5B  show a hollow helix variation for deploying anchors directly through the helix. 
         FIGS. 6A and 6B  show another variation of a helix with a protective sheath which may be advanced over the helix. 
         FIGS. 7A and 7B  show another variation of a helix with an atraumatic member which may be advanced longitudinally through the helix. 
         FIG. 8  shows another variation of a helix with a blunted member which may be advanced longitudinally through the helix. 
         FIGS. 9A and 9B  show a helix which may be energized to reform into a straightened configuration, respectively, to facilitate its withdrawal from tissue. 
         FIG. 10  shows a helix variation which may be energized by a power source for use in ablating surrounding tissue. 
         FIGS. 11A and 11B  show side views of one variation of the tissue manipulation assembly having cam-actuated extension members. 
         FIGS. 11C and 11D  show detail views of the cam-actuation for the assembly of  FIGS. 11A and 11B . 
         FIGS. 12A and 12B  show side views of another variation of extension members which are biased towards one another. 
         FIGS. 13A and 13B  show side views of another variation of extension members which are actuated via a linkage assembly. 
         FIGS. 14A to 14C  show side views of another variation of extension members which are actuatable via one or more hinged arms interconnecting the extension members. 
         FIGS. 15A and 15B  show side views of another variation where one or more extension members are biased away from one another. 
         FIGS. 16A and 16B  show side views of another variation where one or more extension members are configured to be passively biased. 
         FIGS. 17A and 17B  show side views of another variation of extension members which are actuatable via a translatable sleeve. 
         FIG. 18  shows a side view of a tissue manipulation assembly with a lower extension member having a longer length than the upper extension member. 
         FIG. 19  shows a side view of another variation where one or both extension members may have tips atraumatic to tissue. 
         FIGS. 20A and 20B  views of a variation of lower extension members which may be configured to be actuatable. 
         FIG. 20C  show a top view of a lower extension member which may be configured into a “C” shape. 
         FIGS. 21A and 21B  show perspective and top views of a lower extension member having one or more energize-able wires disposed thereon for tissue ablation. 
         FIG. 22A  is a detail side view of an ablative tissue manipulation assembly advanced through a shape-lockable overtube and positioned adjacent to a tissue wall. 
         FIG. 22B  is a detail side view of assembly shown in  FIG. 22A  forming a tissue fold. 
         FIG. 22C  is a detail side view of additional tissue folds prepared to be approximated together. 
         FIG. 22 .D is detail side view of the tissue folds shown in  FIG. 22C  now approximated together. 
         FIG. 22E  is a detail side view of the approximated tissue folds shown in  FIG. 22D  now fused together. 
         FIGS. 23A to 23C  show side views of a tissue manipulation assembly which may be configured to articulate into an angle relative to the tubular body. 
         FIGS. 24A and 24B  show side and perspective detail views, respectively, of a launch tube specially configured to flex in specified planes. 
         FIGS. 24C and 24D  show side views of a portion of the launch tube having one or more coatings or coverings. 
         FIG. 25  shows an illustrative side view of the angle formed between the deployed needle assembly and a longitudinal axis of the tissue manipulation assembly. 
         FIG. 26A  shows a partial side view of a launch tube variation having an extended launch tube distal portion for aligning the needle body for deployment. 
         FIGS. 26B and 26C  show cross-sectional views of the needle body and launch tube distal portion having various keyed cross-sectional areas. 
         FIG. 27A  shows another cross-sectional view where the needle body may be keyed to the launch tube. 
         FIG. 27B  shows a side view of the keyed needle body of  FIG. 27A . 
         FIG. 28  shows a partial side view of an over-driven launch tube. 
         FIGS. 29A and 29B  show partial side views of an assembly having curved deployable needle assemblies. 
         FIG. 30  shows a variation where the needle body may be curved via an anvil. 
         FIG. 31  shows another variation in which an optical fiber or an optical fiber configured as a needle body may be advanced through a launch tube to provide visualization. 
         FIG. 32  shows a variation of the needle body which may be ultrasonically actuated. 
         FIG. 33  shows a torqueable variation of the needle body. 
         FIGS. 34A and 34B  show needle body variations which may be configured to deploy tissue anchors via a side opening. 
         FIGS. 35A to 35C  show end views of a tissue manipulation assembly which may incorporate various colors into the device to facilitate orientation. 
         FIGS. 36A to 36C  show the corresponding top views, respectively, of the device of  FIGS. 35A to 35C . 
         FIGS. 37A to 37D  show side views of various needle bodies which may be colored, have visual markers thereon, dimpled, or have radio-opaque coatings respectively. 
         FIGS. 38A to 38C  show partial side views of variations of a handle for controlling and articulating the tissue manipulation assembly. 
         FIGS. 39A to 39C  show top, side, and cross-sectional views, respectively, of another variation of a handle having a multi-position locking and needle assembly advancement system. 
         FIG. 39D  shows an assembly view of the handle of  FIG. 39A  connected to the tissue manipulation assembly via a rigid or flexible tubular body or shaft. 
         FIGS. 40A and 40B  show perspective and cross-sectional views, respectively, of another variation of a handle having a reversible configuration. 
         FIGS. 41A and 41B  show partial cross-sectional side and detail views, respectively, of another variation of a handle having a pivotable articulation control. 
         FIG. 42A  shows a side view of the handle of  FIG. 41A  having the multi-position locking and needle assembly advancement system. 
         FIGS. 42B to 42D  show end views of the handle of  FIG. 42A  and the various positions of the multi-position locking and needle assembly advancement system. 
         FIG. 43A  shows a perspective view of one variation of the multi-position locking and needle assembly advancement system. 
         FIGS. 43B to 43E  show illustrative side views of the system of  FIG. 43A  configured in various locking and advancement positions. 
         FIG. 44  illustrates a side view of a needle deployment assembly which may be loaded or advanced into an approximation assembly. 
         FIG. 45A  shows a side view of one variation of a needle deployment assembly. 
         FIG. 45B  shows an exploded assembly of  FIG. 45A  in which the tubular sheath is removed to reveal the anchor assembly and elongate pusher element. 
         FIGS. 46A and 46B  show partial cross-sectional side views of a shuttle element advanced within the needle assembly housing. 
         FIGS. 47A and 47B  illustrate one variation of deploying the anchors using the needle assembly. 
         FIG. 47C  illustrates a partial cross-sectional view of one variation of the needle and anchor assemblies positioned within the launch tube. 
         FIG. 48  shows a side view of another variation in which a manipulatable grasping needle assembly may be loaded into the approximation assembly. 
         FIGS. 49A and 49B  show detail side views of a variation of the manipulatable grasping needle of  FIG. 48 . 
         FIGS. 50A and 50B  show detail side views of another variation of the manipulatable grasping needle which may be utilized to deploy anchors. 
         FIGS. 51A and 51  B show partial cross-sectional views of various methods for aligning a suture through the anchor assembly within the needle assembly. 
         FIG. 51C  shows a partial cross-sectional view of an anchor assembly variation utilizing a spacer between adjacent anchors within the needle assembly. 
         FIGS. 52A and 52B  show perspective detail views of unexpanded anchors having interlocking features on one or more of the collars for temporarily interlocking the anchors and/or elongate pusher to one another. 
         FIG. 52C  shows a detail perspective view of a curved interlocking feature which may be integrated on the distal end of the elongate pusher. 
         FIGS. 53A and 53B  show another variation of an interlocking feature which may be integrated into one or more anchors. 
         FIGS. 54A to 54C  show a curved-tab locking feature variation which may be utilized in deploying one or more anchors. 
         FIGS. 55A to 55C  show an interlocking feature variation which may be utilized in deploying one or more anchors. 
         FIGS. 56A to 56C  show a tabbed locking feature variation which may be utilized in deploying one or more anchors. 
         FIGS. 57A to 57C  show a pin and groove locking feature variation which may be utilized in deploying one or more anchors. 
         FIGS. 58A to 58C  show a rotational coil locking feature variation which may be utilized in deploying one or more anchors. 
         FIGS. 59A to 59C  show an electrolytic joint locking feature variation which may be utilized in deploying one or more anchors. 
         FIGS. 60A to 60C  show a ball-groove locking feature variation which may be utilized in deploying one or more anchors. 
         FIG. 61  A to  61 C show a balled-joint locking feature variation which may be utilized in deploying one or more anchors. 
         FIGS. 62A to 62C  show a magnetic locking feature variation which may be utilized in deploying one or more anchors. 
         FIG. 63  shows a locking feature variation utilizing a cross-member. 
         FIGS. 64A to 64C  show various additional feature for controlling the deployment of anchors. 
         FIG. 65  shows a variation for deploying multiple anchors adjacently aligned within a single needle assembly. 
         FIGS. 66A to 66C  show partial cross-sectional side, bottom, and end views, respectively, of another variation for deploying multiple anchors in a controlled manner via corresponding retaining tabs. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     In creating tissue plications, a tissue plication tool having a distal tip may be advanced (transorally, transgastrically, etc.) into the stomach. The tissue may be engaged or grasped and the engaged tissue may be moved to a proximal position relative to the tip of the device, thereby providing a substantially uniform plication of predetermined size. Examples of creating and forming tissue plications may be seen in further detail in U.S. patent application Ser. No. 10/735,030 filed Dec. 12, 2003, which is incorporated herein by reference in its entirety. 
     In order to first create the plication within a body lumen of a patient, various methods and devices may be implemented. The anchoring and securement devices may be delivered and positioned via an endoscopic apparatus that engages a tissue wall of the gastrointestinal lumen, creates one or more tissue folds, and disposes one or more of the anchors through the tissue fold(s). The tissue anchor(s) may be disposed through the muscularis and/or serosa layers of the gastrointestinal lumen. 
     Generally, in creating a plication through which a tissue anchor may be disposed within or through, a distal tip of a tissue application apparatus may engage or grasp the tissue and move the engaged tissue to a proximal position relative to the tip of the device, thereby providing a substantially uniform plication of predetermined size. 
     Formation of a tissue fold may be accomplished using at least two tissue contact areas that are separated by a linear or curvilinear distance, wherein the separation distance between the tissue contact points affects the length and/or depth of the fold. In operation, a tissue grabbing assembly engages or grasps the tissue wall in its normal state (i.e., non-folded and substantially flat), thus providing a first tissue contact area. The first tissue contact area then is moved to a position proximal of a second tissue contact area to form the tissue fold. The tissue anchor assembly then may be extended across the tissue fold at the second tissue contact area. Optionally, a third tissue contact point may be established such that, upon formation of the tissue fold, the second and third tissue contact areas are disposed on opposing sides of the tissue fold, thereby providing backside stabilization during extension of the anchor assembly across the tissue fold from the second tissue contact area. 
     The first tissue contact area may be utilized to engage and then stretch or rotate the tissue wall over the second tissue contact area to form the tissue fold. The tissue fold may then be articulated to a position where a portion of the tissue fold overlies the second tissue contact area at an orientation that is substantially normal to the tissue fold. A tissue anchor may then be delivered across the tissue fold at or near the second tissue contact area. An apparatus in particular which is particularly suited to deliver the anchoring and securement devices described herein may be seen in further detail in co-pending U.S. patent application Ser. No. 10/840,950 filed May 7, 2004, which is incorporated herein by reference in its entirety. 
     An illustrative side view of a tissue plication assembly  10  which may be utilized with the tissue anchors described herein is shown in  FIG. 1A . The plication assembly  10  generally comprises a catheter or tubular body  12  which may be configured to be sufficiently flexible for advancement into a body lumen, e.g., transorally, percutaneously, laparoscopically, etc. Tubular body  12  may be configured to be torqueable through various methods, e.g., utilizing a braided tubular construction, such that when handle  16  is manipulated and rotated by a practitioner from outside the body, the torquing force is transmitted along body  12  such that the distal end of body  12  is rotated in a corresponding manner. 
     Tissue manipulation assembly  14  is located at the distal end of tubular body  12  and is generally used to contact and form the tissue plication, as mentioned above.  FIG. 1B  shows an illustrative detail side view and  FIG. 1C  shows a perspective view of tissue manipulation assembly  14  which shows launch tube  18  extending from the distal end of body  12  and in-between the arms of upper extension member or bail  20 . Launch tube  18  may define launch tube opening  24  and may be pivotally connected near or at its distal end via hinge or pivot  22  to the distal end of upper bail  20 . Lower extension member or bail  26  may similarly extend from the distal end of body  12  in a longitudinal direction substantially parallel to upper bail  20 . Upper bail  20  and lower bail  26  need not be completely parallel so long as an open space between upper bail  20  and lower bail  26  is sufficiently large enough to accommodate the drawing of several layers of tissue between the two members. 
     Upper bail  20  is shown in the figure as an open looped member and lower bail  26  is shown as a solid member; however, this is intended to be merely illustrative and either or both members may be configured as looped or solid members. Tissue acquisition member  28  may be an elongate member, e.g., a wire, hypotube, etc., which terminates at a tissue grasper or engager  30 , in this example a helically-shaped member, configured to be reversibly rotatable for advancement into the tissue for the purpose of grasping or acquiring a region of tissue to be formed into a plication. Tissue acquisition member  28  may extend distally from handle  16  through body  12  and distally between upper bail  20  and lower bail  26 . Acquisition member  28  may also be translatable and rotatable within body  12  such that tissue engager  30  is able to translate longitudinally between upper bail  20  and lower bail  26 . To support the longitudinal and rotational movement of acquisition member  28 , an optional guide or linear bearing  32  may be connected to upper  20  or lower bail  26  to freely slide thereon. Guide  32  may also be slidably connected to acquisition member  28  such that the longitudinal motion of acquisition member  28  is supported by guide  32 . 
     An example of a tissue plication procedure is seen in  FIGS. 2A to 2D  for delivering and placing a tissue anchor and is disclosed in further detail in co-pending U.S. patent application Ser. No. 10/840,950 filed May 7, 2004, which has been incorporated by reference above. Tissue manipulation assembly  14 , as seen in  FIG. 2A , may be advanced into a body lumen such as the stomach and positioned adjacent to a region of tissue wall  40  to be plicated. During advancement, launch tube  18  may be configured in a delivery profile such that tube  18  is disposed within or between the arms of upper bail  20  to present a relatively small profile. 
     Once tissue manipulation assembly  14  has been desirably positioned relative to tissue wall  40 , tissue grasper or engager  30  may be advanced distally such that tissue grasper or engager  30  comes into contact with tissue wall  40  at acquisition location or point  42 . As tissue grasper or engager  30  is distally advanced relative to body  12 , guide  32 , if utilized, may slide distally along with tissue grasper or engager  30  to aid in stabilizing the grasper. If a helically-shaped tissue grasper or engager  30  is utilized, as illustrated in  FIG. 2B , it may be rotated from its proximal end at handle  16  and advanced distally until the tissue at point  42  has been firmly engaged by tissue grasper or engager  30 . This may require advancement of tissue grasper or engager  30  through the mucosal layer and at least into or through the underlying muscularis layer and possibly into or through the serosa layer. 
     The grasped tissue may then be pulled proximally between upper  20  and lower bails  26  via tissue grasper or engager  30  such that the acquired tissue is drawn into a tissue fold  44 , as seen in  FIG. 2C . As tissue grasper or engager  30  is withdrawn proximally relative to body  12 , guide  32  may also slide proximally to aid in stabilizing the device especially when drawing the tissue fold  44 . 
     Once the tissue fold  44  has been formed, launch tube  18  may be advanced from its proximal end at handle  16  such that a portion  46  of launch tube  18 , which extends distally from body  12 , is forced to rotate at hinge or pivot  22  and reconfigure itself such portion  46  forms a curved or arcuate shape that positions launch tube opening  24  perpendicularly relative to a longitudinal axis of body  12  and/or bail members  20 ,  26 . Launch tube  18 , or at least portion  46  of launch tube  18 , is preferably fabricated from a highly flexible material or it may be fabricated, e.g., from Nitinol tubing material which is adapted to flex, e.g., via circumferential slots, to permit bending. Alternatively, assembly  14  may be configured such that launch tube  18  is reconfigured simultaneously with the proximal withdrawal of tissue grasper or engager  30  and acquired tissue  44 . 
     As discussed above, the tissue wall of a body lumen, such as the stomach, typically comprises an inner mucosal layer, connective tissue, the muscularis layer and the serosa layer. To obtain a durable purchase, e.g., in performing a stomach reduction procedure, the staples or anchors used to achieve reduction of the body lumen are preferably engaged at least through or at the muscularis tissue layer, and more preferably, the serosa layer. Advantageously, stretching of tissue fold  44  between bail members  20 ,  26  permits an anchor to be ejected through both the muscularis and serosa layers, thus enabling durable gastrointestinal tissue approximation. 
     As shown in  FIG. 2D , once launch tube opening  24  has been desirably positioned relative to the tissue fold  44 , needle assembly  48  may be advanced through launch tube  18  via manipulation from its proximal end at handle  16  to pierce preferably through a dual serosa layer through tissue fold  44 . Needle assembly  48  is preferably a hollow tubular needle through which one or several tissue anchors may be delivered through and ejected from in securing the tissue fold  44 , as further described below. 
     Because needle assembly  48  penetrates the tissue wall twice, it exits within the body lumen, thus reducing the potential for injury to surrounding organs. A detail cross sectional view is shown  FIG. 3A  of anchor delivery assembly  50  in proximity to tissue fold F. In this example, tissue fold F may comprise a plication of tissue created using the apparatus described herein or any other tool configured to create such a tissue plication. Tissue fold F may be disposed within a gastrointestinal lumen, such as the stomach, where tissue wall W may define the outer or serosal layer of the stomach. Anchor delivery assembly may generally comprise launch tube  18  and needle assembly  48  slidingly disposed within launch tube lumen  52 . Needle assembly  48  is generally comprised of needle  54 , which is preferably a hollow needle having a tapered or sharpened distal end to facilitate its travel into and/or through the tissue. Other parts of the assembly, such as upper and lower bail members  20 ,  26 , respectively, and tissue acquisition member  28  have been omitted from these figures only for clarity. 
     Once launch tube  18  has been desirably positioned with respect to tissue fold F, needle  54  may be urged or pushed into or through tissue fold F via delivery push tube or catheter  64  from its proximal end preferably located within handle  16 . Delivery push tube or catheter  64  may comprise an elongate flexible tubular member to which needle  54  is connected or attached via joint  62 . Alternatively, needle  54  and delivery push tube  64  may be integrally formed from a singular tubular member. Needle  54  may define needle lumen  56  through which basket anchor assembly  66 , i.e., distal anchor  58  and/or proximal anchor  60  may be situated during deployment and positioning of the assembly. A single suture or flexible element  76  (or multiple suture elements) may connect proximal anchor  60  and distal anchor  58  to one another. For instance, element  76  may comprise various materials such as monofilament, multifilament, or any other conventional suture material, elastic or elastomeric materials, e.g., rubber, etc. 
     Alternatively, metals which are biocompatible may also be utilized for suture materials. For instance, sutures may be made from metals such as Nitinol, stainless steels, Titanium, etc., provided that they are formed suitably thin and flexible. Using metallic sutures with the anchoring mechanisms described herein may additionally provide several benefits. For example, use of metallic suture material may decrease any possibilities of suture failure due to inadvertent cutting or shearing of the suture, it may provide a suture better able to withstand the acidic and basic environment of the gastrointestinal system, and it may also enhance imaging of the suture and anchor assembly if examined under conventional imaging systems such as X-rays, fluoroscopes, MRI, etc. As used herein, suture  76  may encompass any of these materials or any other suitable material which is also biocompatible. 
     Needle  54  may optionally define a needle slot along its length to allow suture  76  to pass freely within and out of needle  54  when distal anchor  58  is ejected from needle lumen  56 . Alternatively, rather than utilizing a needle slot, needle  54  may define a solid structure with suture  76  being passed into and through needle lumen  56  via the distal opening of needle  54 . 
     The proximal end of suture  76  may pass slidingly through proximal anchor  60  to terminate in a suture loop. The proximal end of suture  76  may terminate proximally of the apparatus  10  within control handle  16 , proximally of control handle  16 , or at some point distally of control handle  16 . In this variation, a suture loop may be provided to allow for a grasping or hooking tool to temporarily hold the suture loop for facilitating the cinching of proximal  60  and distal  58  anchors towards one another for retaining a configuration of tissue fold F, as described in further detail in U.S. patent application Ser. No. 10/840,950, which has been incorporated by reference above. 
     After needle assembly  48  has been pushed distally out through launch tube opening  24  and penetrated into and/or through tissue fold F, as shown in  FIG. 3A , anchor pushrod or member  78  may be actuated also via its proximal end to eject distal anchor  58 . Once distal anchor  58  has been ejected distally of tissue fold F, needle  54  may be retracted back through tissue fold F by either retracting needle  54  back within launch tube lumen  18  or by withdrawing the entire anchor delivery assembly  50  proximally relative to tissue fold F. 
     Once needle  54  has been retracted, proximal anchor  60  may then be ejected from launch tube  18  on a proximal side of tissue Fold F. With both anchors  58 ,  60  disposed externally of launch tube  18  and suture  76  connecting the two, proximal anchor  60  may be urged into contact against tissue fold F, as shown in  FIG. 3B . As proximal anchor  60  is urged against tissue fold F, proximal anchor  60  or a portion of suture  76  may be configured to provide any number of directionally translatable locking mechanisms which provide for movement of an anchor along suture  76  in a first direction and preferably locks, inhibits, or prevents the reverse movement of the anchor back along suture  76 . In other alternatives, the anchors may simply be delivered through various elongate hollow tubular members, e.g., a catheter, trocars, etc. 
     The basket anchors may comprise various configurations suitable for implantation within a body lumen. Basket anchors are preferably reconfigurable from a low profile delivery configuration to a radially expanded deployment configuration in which a number of struts, arms, or mesh elements may radially extend once released from launch tube  18  or needle  54 . Materials having shape memory or superelastic characteristics or which are biased to reconfigure when unconstrained are preferably used. e.g., spring stainless steels, Ni—Ti alloys such as Nitinol, etc. In  FIGS. 3A and 3B , each of the basket anchor  58 ,  60  is illustrated as having a number of reconfigurable struts or arm members  72  extending between distal collar  68  and proximal collar  70 ; however, this is intended only to be illustrative and suitable basket anchors are not intended to be limited to baskets only having struts or arms. Examples of suitable anchors are further described in detail in U.S. patent application Ser. No. 10/612,170, which has already been incorporated herein above. 
       FIG. 3B  shows distal basket anchor  58  delivered through tissue fold F via needle  54  and launch tube  18 . As above, the other parts of the plication assembly, such as upper and lower bail members  20 ,  26 , respectively, and tissue acquisition member  28  have been omitted from these figures only for clarity. 
       FIG. 3B  shows one variation where a single fold F may be secured between proximal anchor  60  and distal anchor  58 ′. As seen, basket anchor  58 ′ has been urged or ejected from needle  54  and is shown in its radially expanded profile for placement against the tissue surface. In such a case, a terminal end of suture  76  may be anchored within the distal collar of anchor  58 ′ and routed through tissue fold F and through, or at least partially through, proximal anchor  60 , where suture  76  may be cinched or locked proximally of, within, or at proximal anchor  60  via any number of cinching mechanisms. Proximal anchor  60  is also shown in a radially expanded profile contacting tissue fold F along tissue contact region  74 . Locking or cinching of suture  76  proximally of proximal anchor  60  enables the adequate securement of tissue fold F. 
     Various examples of cinching devices and methods which may be utilized with the tools and devices herein are described in further detail in U.S. patent application Ser. No. 10/840,950 filed May 7, 2004, which has been incorporated herein above. 
     If additional tissue folds are plicated for securement, distal basket anchor  58  may be disposed distally of at least one additional tissue fold F′, as shown in  FIG. 3B , while proximal anchor  60  may be disposed proximally of tissue fold F. As above, suture  76  may be similarly affixed within distal anchor  58  and routed through proximal anchor  60 , where suture  76  may be cinched or locked via proximal anchor  60 , as necessary. If tissue folds F and F′ are to be positioned into apposition with one another, distal basket anchor  58  and proximal anchor  60  may be approximated towards one another. As described above, proximal anchor  60  is preferably configured to allow suture  76  to pass freely therethrough during the anchor approximation. However, proximal anchor  60  is also preferably configured to prevent or inhibit the reverse translation of suture  76  through proximal anchor  60  by enabling unidirectional travel of anchor  60  over suture  76 . This cinching feature thereby allows for the automated locking of anchors  58 ,  60  relative to one another during anchor approximation. 
     With respect to the anchor assemblies described herein, the types of anchors shown and described are intended to be illustrative and are not limited to the variations shown. For instance, several of the tissue anchor variations are shown as “T”-type anchors while other variations are shown as reconfigurable “basket”-type anchors, which may generally comprise a number of configurable struts or legs extending bet \\eon at least two collars or support members. Other variations of these or other types of anchors are also contemplated for use in an anchor assembly. Moreover, a single type of anchor may be used exclusively in an anchor assembly; alternatively, a combination of different anchor types may be used in an anchor assembly. Furthermore, the different types of cinching or locking mechanisms are not intended to be limited to any of the particular variations shown and described but may be utilized in any of the combinations or varying types of anchors as practicable. 
     Tissue Engagement Tools 
     As mentioned above, tissue acquisition member  28  may be an elongate member, e.g., a wire, hypotube, etc., which has a tissue grasper or engager  30  attached or integrally formed at its distal end for grasping or engaging the tissue. In one variation, the tissue grasper may be formed as a helix having a uniform outer diameter with a constant pitch, as shown in the detail view of helix  80  in  FIG. 4A . Helix  80  may be attached to acquisition member  28  via any suitable fastening method, e.g., adhesives, solder, etc. Alternatively, helix  80  may be integrally formed from the distal portion of acquisition member  28  by winding or coiling the distal portion in a helix configuration. 
     In another variation, the tissue grasper may be formed into a helix  82  having a pitch which is greater relatively than helix  80  such that the variation of helix  82  has relatively fewer windings, as shown in  FIG. 4B . Alternatively, a multi-pitch helix  84  may be formed having one or more regions with varying pitch along a length of helix  84 . As seen in  FIG. 4C , multi-pitch helix  84  may have a distal portion  86  having a relatively lower pitch and a proximal portion having a relatively higher pitch  88 . A single helix having regions of varied pitch may be utilized to initially pierce and grasp tissue onto the region of lower pitch  86 ; when the helix  84  is rotated to advance into or through the tissue, the pierced tissue advanced over helix  84  may be wound upon the region of higher pitch  88  where the tissue may be better adhered to helix  84  by the tighter windings. 
     Another variation of a tissue grasper may be seen in  FIG. 4D . In this variation, helix  90  may have a piercing needle  92  extending through the center and protruding distally of helix  90  to facilitate piercing of the tissue and initial entry of helix  90  into the tissue. Yet another variation is shown in  FIG. 4E  where a dual-helix variation may be utilized. Here, first helix  94  may be inter-wound with second helix  96  in a dual helix configuration. 
     Another variation is shown in  FIG. 4F  in which helix  98  may define a helix having a decreasing diameter distally of acquisition member  28 . In this variation or any of the variations of the helix described herein, certain aspects of one helix variation may be utilized in any number of combinations with any of the other aspects of other variations as practicable. For instance, the variation of the dual-helix in  FIG. 4E  may also comprise the piercing needle  92  or  FIG. 4D . This variation may also include aspects of the helix  84  having varying regions of differing pitch, as shown in  FIG. 4C , and so on in any number of combinations as practicable. 
       FIG. 4G  shows yet another variation in dual grasping assembly  100  where helix  102  may utilize articulatable grasping jaw members  104 ,  106  in combination with the helix  102 . As the helix  102  initially pierces and rotatingly retains the tissue, acquisition member  28  may be withdrawn proximally to pull the tissue between jaws  104 ,  106 , which may then be articulated to further clamp onto the tissue to ensure tissue retention by assembly  100 . Articulatable jaws  104 ,  106  may optionally define serrations or teeth  108 ,  110  upon one or more of the jaw members  104 ,  106  in contact against the tissue to further facilitate tissue retention. 
     In addition to the various configurations, the tissue grasper may be further utilized to retain tissue via tissue anchors.  FIGS. 5A and 5B  show side views of a helix variation  120  which may be completely or partially hollow for engaging tissue. One or more deployable anchors  124  may be positioned within or advanced through hollow helix  120 . With at least the distal portion or tip of hollow helix  120  pierced into or through the tissue T, as shown in  FIG. 5A , tissue anchor  124  may be urged from opening  122  defined in hollow helix  120  through any number of methods, e.g., an elongate pusher. Once tissue anchor  124  has been deployed or ejected from distal opening  122 , helix  120  may be withdrawn proximally partially or entirely from tissue T while leaving anchor  124  behind. Anchor  124  may be connected to suture  126  which may be routed through or connected to helix  120  such that creation of a tissue fold from tissue T may be achieved by pulling anchor  124  proximally, as shown in  FIG. 5B . After the tissue T has been desirably manipulated or folded, suture  126  may be released from helix  120  so that helix  120  may be withdrawn from the region. 
     During manipulation of the tissue and articulation of the helix within the patient&#39;s body, e.g., within the stomach, optional measures may be taken to prevent the helix from inadvertently damaging any surrounding tissue. One variation may be seen in the detail side view of sheathed helix assembly  130  in  FIG. 6A . The sheath  132  may completely or partially cover helix  80  to present an atraumatic surface to the surrounding tissue when the helix  80  is not in use within the patient&#39;s body, as shown in  FIG. 6B . Additionally, sheath  132  may also be utilized outside the patient to protect helix  80  when handled for transport or during preparation of the device for use. Sheath  132  may be optionally advanced distally over helix  80  or helix  80  may be withdrawn proximally into sheath  132 . 
     Another variation for providing an atraumatic surface for the helix to surrounding tissue may be seen in  FIGS. 7A and 7B . As shown, helix assembly  140  may have an insertion member  142  which defines an atraumatic distal end  144  advanced through the center of helix  80 . When the helix  80  is not in use, insertion member  142  may be advanced distally within helix  80  to the distal end of helix  80  such that inadvertent tissue piercing is prevented by member  142 . 
     Yet another variation is shown in  FIG. 8  in which blunted element  150  may be advanced through the center of helix  80  via an elongate delivery member  152 . When helix  80  is utilized, member  150  may be withdrawn proximally relative to helix  80  in the same manner as helix assembly  140  above. 
     Another variation of the helix assembly is shown in the illustrative side views of  FIGS. 9A and 9B . In this variation, reconfigurable helix  160  may be configured to have a configuration for facilitating its advancement into tissue or for withdrawing the helix  160  from tissue.  FIG. 9A  shows reconfigurable helix  160  is seen in its coiled configuration for piercing and adhering tissue thereto. Helix  160  may be fabricated from a shape memory alloy, such as Nitinol, to have a relaxed configuration of a helix, as shown in  FIG. 9A . Once energy is applied, helix  160  may be configured to reconfigure itself into a straightened configuration  160 ′, as shown in  FIG. 9B , to facilitate its removal from the tissue. Helix  160  may be electrically connected via electrically conductive acquisition member  162  and connection or wires  164  to a power source  166 . If helix  160  were advanced into tissue in its coiled configuration, withdrawal of the helix  160  may be quickly effected by applying energy to helix  160  via power source  166 . Alternatively, power may be applied to helix  160  such that its straightened configuration  160 ′ takes shape to facilitate piercing into tissue. Power may then be removed such that helix  160  conforms into its coiled configuration once in the tissue such that the tissue adheres to the helix  160 . 
     In the reconfigurable helix  160  above, the length of helix  160  may be insulated to shield the surrounding tissue from the applied energy. However, another variation of the tissue grasping member may be seen in energizable helix  170  in  FIG. 10 . In this variation, the entire length or a partial length of helix  170  may be uninsulated such that when helix  170  is energized through electrical connection  174  and through electrically conductive acquisition member  172  via power source  176 , the uninsulated portion or portions of energized helix  170  may be utilized to contact and ablate selected regions of tissue. For instance, prior to or after a tissue fold has been formed, helix  170  may be energized to ablate the areas of the tissue which are to be approximated towards one another to facilitate tissue adhesion between selected regions of tissue folds. 
     As mentioned above, in this variation or any of the variations of the helix, certain aspects of one helix variation may be utilized in any number of combinations with any of the other aspects of other variations as practicable. 
     Extension Members 
     In addition to the variations of the tissue grasper or helix, the upper and/or lower extension members or bails may also be configured into a variety of embodiments which may be utilized in any number of combinations with any of the helix variations as practicable. Although the upper and lower extension members or bails may be maintained rigidly relative to one another, the upper and/or lower extension members may be alternatively configured to articulate from a closed to an open configuration or conversely from an open to a closed configuration for facilitating manipulation or stabilization of tissue drawn between the bail members. 
     In operation, once the selected region of tissue has been acquired by the tissue grasper  30 , the obtained tissue may be proximally withdrawn between the bail members, which may act as stabilizers for the tissue. To accommodate large portions of grasped tissue between the bail members, one or both bail members may be articulated or urged to open apart from one another to allow the tissue to enter and become positioned between the bail members. One or both bail members may then be articulated or urged to clamp or squeeze the tissue fold between the bail members to facilitate stabilization of the tissue fold for tissue manipulation and/or anchor deployment and/or any other procedure to be undertaken. 
     One such articulatable extension assembly may be seen in the side views of  FIGS. 11A and 11B . Other features such as the launch tube and tubular body have been omitted merely for the sake of clarity for the following illustrations. As seen in  FIG. 11  A, upper extension member  182  and lower extension member  184  of active extension assembly  180  may be configured to have an open or spread configuration relative to one another when guide or linear bearing  186  is positioned distally along, upper extension member  182 . Linear bearing  186  may be configured to slide freely along upper extension member  182  when urged by acquisition member  28  distally or proximally. Rather than having linear bearing  186  slide along upper extension member  182 , it may be configured alternatively to slide along lower extension member  184 . 
     With tissue grasper  30  and acquisition member  28  distally protruding from extension members  182 ,  184 , as shown in  FIG. 11A , the desired region of tissue may be acquired by rotating tissue grasper  30  into the tissue. Once tissue has been acquired by tissue grasper  30 , the tissue may be pulled between the opened extension members  182 ,  184  by proximally withdrawing tissue grasper  30  and linear bearing  186  may be forced proximally over upper extension member  182 , as shown in the detail view of  FIG. 11C . One or more projections or pistons  188  may protrude proximally from linear bearing  186  such that one or more of these projections  188  comes into contact with actuation lever or member  192 , as shown in  FIG. 11D , which may be located proximally of extension members  182 ,  184  and connected in a pivoting relationship with lower extension member  184  about pivot  190 . As linear bearing  186  is urged proximally and projection  188  presses against actuation lever  192 , lower extension member  184  may be rotated about pivot  190  such that lower extension member  184  is urged towards upper extension member  182  to securely clamp onto and retain any tissue positioned between the extension members  182 ,  184 . 
     Another articulatable extension assembly may be seen in assembly  200  in the side views of  FIGS. 12A and 12B . In this variation, upper extension member  202  may project distally opposite lower extension member  204  which may be biased to close towards upper extension member  202 . When tissue grasper  30  is advanced to engage tissue, as shown in  FIG. 12A , linear bearing  206  may be urged distally along upper extension member  202  via acquisition member  28  such that lower extension member  204  is forced or wedged away from upper extension member  202 . Once the tissue is engaged and withdrawn proximally, linear bearing  206  may be pulled proximally while sliding along lower member  204  and allowing lower member  204  to spring back towards upper member  202  and over any tissue positioned therebetween, as shown in  FIG. 12B . 
     Another articulatable extension assembly is shown in the side views of extension assembly  210  of  FIGS. 13A and 13B . In this variation, upper extension member  212  and/or lower extension member  214  may be connected to linkage assembly  218  located proximally of the extension members  212 ,  214 . Linkage assembly  218  may be manipulated via any number of control mechanisms such as control wires to urge extension members  212 ,  214  between open and closed configurations. Alternatively, linkage assembly  218  may be configured to open or close upon the proximal or distal advancement of linear bearing  216  relative to linkage assembly. 
       FIGS. 14A to 14C  show side views of another variation in extension assembly  220  where upper and lower extension members  222 ,  224  are articulatable between open and closed configurations via a pivoting arm or member  234  interconnecting the two. In this example, a first end of pivoting arm  234  may be in a pivoting connection at pivot  228  with linear bearing  226 , which may slide translationally along upper member  222 . A second end of pivoting arm  234  may also be in a pivoting connection with lower extension member  224  at pivot  230 , which may remain fixed to lower member  224 . Acquisition member  28  may also be in a third pivoting connection with pivoting arm  234  at pivot  232 , which may also be configured to allow for the linear translation of acquisition member therethrough. 
     In operation, when acquisition member  28  and tissue grasper  30  is advanced distally, as shown in  FIG. 14A , both upper and lower extension members  222 ,  224  are in a closed configuration with linear bearing  226  being advanced distally along upper extension member  222 . As tissue grasper  30  is withdrawn proximally between extension members  222 ,  224 , pivoting arm  234  may be pivoted about fixed pivot  230  on lower member  224  while upper member  222  is urged into an open configuration as linear bearing  226  is urged proximally over upper member  222 , as shown in  FIG. 14B . This expanded or open configuration allows for the positioning of large portions of tissue to be drawn between the extension members  222 ,  224  for stabilization.  FIG. 14C  shows tissue grasper  30  as having been further withdrawn and linear bearing  226  urged proximally such that upper member  222  is urged back into a closed configuration relative to lower member  224 . The closing of extension members  222 ,  224  allows for the members to further clamp upon any tissue therebetween for further stabilization of the tissue. 
       FIGS. 15A and 15B  show another alternative in active extension assembly  240 . In this variation, upper extension member  242  may be biased to extend away from lower extension member  244 . As shown in  FIG. 15A , upper extension member  242  may remain in an open configuration relative to lower member  244  for receiving tissue therebetween. In this variation, biased upper member  242  may be urged into a closed configuration by pivoting the launch tube  18  about pivot  246 , which may be located along upper member  242 . As launch tube  18  is pivoted into an anchor deployment configuration, the pivoting action may urge upper member  242  towards lower member  244  to clamp upon any tissue therebetween. 
       FIGS. 16A and 16B  show yet another alternative in assembly  250  where upper extension member  252  and/or lower extension member  254  may be passively urged into an open configuration. In this example, lower extension member  254  is shown as being flexed from a relaxed configuration in  FIG. 16A  to a flexed configuration in  FIG. 16B . As linear bearing  256  is withdrawn proximally, any tissue engaged to tissue grasper  30  may urge lower extension member  254  from its normal position  258  to its flexed and opened position. Accordingly, lower extension member  254  and/or upper extension member  252  may be made from a relatively flexible plastic or metallic material, e.g., Nitinol, spring stainless steel, etc. When tissue is removed from between the extension members  252 ,  254 , lower extension member  254  may return to its normal configuration  258 . 
       FIGS. 17A and 17B  show side views of another assembly  260  in which upper and/or lower extension members  262 ,  264  may be biased or configured to flex away from one another, as shown in  FIG. 17A . Once linear bearing  266  and tissue grasper  30  has been retracted, an outer sleeve  268  slidingly disposed over tubular body  12  may be pushed distally such that sleeve  268  is slid over at least a proximal portion of extension members  262 ,  264  such that they are urged towards one another into a closed configuration onto tissue which may be present therebetween, as shown in  FIG. 17B . 
     Aside from features such as articulation of the extension members, the extension members themselves may be modified. For instance,  FIG. 18  shows a side view of extension assembly  270  where lower extension member  274  may be extended in length relative to upper extension member  272 . The length of lower extension member  274  may be varied depending upon the desired result. Alternatively, upper extension member  272  may be shortened relative to lower extension member  274 . The lengthening of lower extension member  274  may be utilized to present a more stable platform for tissue approximated between the extension members  262 ,  264 . 
     Another alternative for modifying the extension members is seen in the side view of  FIG. 19  in extension assembly  280 . In this example, one or both extension members  282 ,  284  may be configured to have atraumatic blunted ends  286  which may be further configured to be flexible to allow tissue to slide over the ends. Moreover, atraumatic ends  286  may be configured in a variety of ways provided that an atraumatic surface or feature is presented to the tissue. 
     In addition to atraumatic features, the lower extension member of the tissue manipulation assembly may be varied as well. For example, as the needle assembly and tissue anchors are deployed from the launch tube, typically from the upper extension member, it is preferable to have sufficient clearance with respect to the lower extension member so that unhindered deployment is facilitated. One method for ensuring unhindered deployment is via a lower extension member having a split opening defined near or at its distal end, as shown in the perspective view of tissue manipulation assembly  290  in  FIG. 20A . Such a split may allow for any deployed anchors or suture an opening through which to be released from assembly  290 . 
     Additionally, the jaws which define the opening may be articulatable as well relative to lower extension member  294 . As shown in the bottom view of  FIG. 20B , articulatable lower extension assembly  292  may have one or both jaw members  296 ,  298  articulatable via pivots  300 ,  302 , respectively, relative to lower extension member  294  such that one or both jaw members  296 ,  298  are able to be moved between a closed configuration, as shown in  FIG. 20A , and an open configuration, as shown in  FIG. 20B . This variation in assembly  290  may allow for any needle or anchor assemblies to easily clear lower extension member  294 . 
     Another variation of lower extension member  304  is shown in the bottom view of  FIG. 20C . In this variation, an enclosing jaw member  306  may extend from lower extension member  304  such that an opening  308  along either side of extension member  304  is created. Such an opening  308  may create a “C”-shaped lower extension member  304  which may facilitate needle and anchor deployment from the tissue manipulation assembly. 
     Another variation of a tissue manipulation assembly  310  may be seen in the illustrative partial perspective view of  FIG. 21A . In addition to articulation or release features, one or both extension members may be utilized to selectively ablate regions of tissue. Assembly  310  for instance may have a tissue ablation assembly  312  integrated into the lower extension member  320 . Such a tissue ablation assembly  312 , as seen in the top view of  FIG. 21B , may incorporate one or more wires or electrically conductive elements  318  upon lower extension member  320  to create a tissue ablation region. The lower extension member  320  may be fabricated from a non-conductive material upon which wires  318  may be integrated. Alternatively, the entire lower member  320  may be electrically conductive with regions selectively insulated leaving non-insulated areas to create ablation regions  318 . The wires or regions  318  may be electrically connected via wires  314  to power source  316 , which may provide various forms of energy for tissue ablation, e.g., radio-frequency, microwave, etc. 
     One example for use of the ablative tissue manipulation assembly may be seen in  FIGS. 22A to 22E  where tissue approximation assembly  330  may be seen with tissue manipulation assembly  14  advanced through an optional shape-lockable overtube  332 . Ablation region  318  is integrated into the lower extension member  320  of the tissue manipulation assembly, as above. Alternatively, region  318  may, for example, comprise an abrasive surface disposed on lower extension member  320 . Alternatively, the lower extension member  320  may comprise an ablation electrode for injuring mucosal tissue. 
     As seen in  FIG. 22B , when tissue wall  40  is folded between the extension members of assembly  14 , target mucosal tissue  334  contacts lower extension member  320  as well as ablation region  318 . Passive or active actuation of ablation region  318  may then injure and/or remove the target mucosal tissue  334 . As further seen in  FIG. 22C , this procedure may be repeated at one or more additional tissue folds  336 ,  338  that may then be approximated together, as in  FIG. 22D . The contacting injured regions of mucosal tissue promote healing and fusion  340  of the approximated folds, as in  FIG. 22E . 
     Aside from variations on aspects of the tissue manipulation assembly, the entire assembly may also be modified to adjust the tissue manipulation assembly position relative to the tubular body upon which the assembly is attachable.  FIG. 23A  shows a distal portion of tubular body  12  and tissue manipulation assembly  14  connected thereto. While tubular body  12  may comprise a rigid or flexible length, tissue manipulation assembly  14  may be further configured to articulate relative to tubular body  12 , as shown in  FIG. 23B , to further enhance the maneuverability and manipulation capabilities of tissue manipulation assembly  14 . In one example, assembly  14  may be connected to tubular body  12  via a hinged or segmented articulatable portion  350 , shown in the detail  FIG. 23C , which allows assembly  14  to be reconfigured from a low-profile configuration straightened relative to tubular body  12  to an articulated configuration where assembly  14  forms an angle, α, relative to tubular body  12 . The angle, α, may range anywhere from 180° to −180° depending upon the desired level of articulation. Articulatable portion  350  may be configured to allow assembly  14  to become articulated in a single plane or it may also be configured to allow a full range of motion unconstrained to a single plane relative to tubular body  12 . Articulation of assembly  14  may be accomplished any number of various methods, e.g., control wires. 
     Any of the variations of the tissue manipulation assemblies or aspects of various features of the tissue manipulation assemblies is intended to be utilized in any number of combinations with other aspects of other variations as practicable. Moreover, any of the variations relating to the tissue manipulation assemblies may also be used in any number of combinations, as practicable, with the helix variations described above, if so desired. 
     Launch Tube 
     An illustrative side view of a partial launch tube  18  configured for anchor deployment may be seen in  FIG. 24A . Launch tube  18  is typically configured to partially translate relative to the tissue manipulation assembly such that a distal portion of the launch tube  18  may be articulated perpendicularly to the tissue to be pierced. Launch tube  18  may be made from a variety of flexible materials which are flexible yet sufficiently strong to withstand repeated flexing of the tube. 
       FIG. 24B  shows a portion  360  of launch tube  18  which may be fabricated from a metal such as Nitinol, stainless steel, titanium, etc. To facilitate the flexure of tube  18 , such a tube may be selectively scored or cut to enhance the directional flexibility of the tube  18 . Accordingly, in one variation, a plurality of circumferential cuts or slits  366  may be made in the portion of launch tube  18  which is flexed. Cuts  366  may extend between one or more lengths or spines  362 , 364  of uncut tube material which may extend over the length of the flexible portion. These spines  362 ,  364  in combination with the cuts  366  may facilitate the directional flexibility or bending of launch tube  18  in a singular bending plane. Cuts  366  may be made along the launch tube  18  using any number methods, e.g., mechanical cutting, laser cutting, chemical etching, etc. 
     Another variation of launch tube  18  is shown in the partial views of  FIGS. 24C and 24D . Launch tube wall  368  may be seen in  FIG. 24C  with an optional inner covering or coating  370  while  FIG. 24D  shows another variation of launch tube wall  368  with an optional additional outer coating  372 . Inner covering or coating  370  may be comprised of a lubricious material, e.g., PTFE, etc., to facilitate the ease with which the needle assembly may be advanced or withdrawn through launch tube  18 . Moreover, outer covering or coating  372  may also comprise a lubricious material to facilitate the translation of launch tube relative to tubular body  12 . Either or both coatings  370 ,  372  may also ensure the structural integrity of launch tube  18  as well. 
     In advancing launch tube  18  into a configuration where its distal opening is transverse to the tissue to be pierced, launch tube  18  is preferably advanced until the deployed needle body  380  of the needle assembly emerges from launch tube  18  perpendicularly to the tissue drawn between the extension members, and particularly to upper extension member  20 . Thus, the distal opening of launch tube  18  may be configured to form an angle, β, relative generally to the tissue manipulation assembly, as shown in  FIG. 25 . Angle, β, is preferably close to 90° but it may range widely depending upon the amount of tissue grasped as well as the angle desired; thus, the launch tube  18  may be configured to translate over a specified distance via detents or locks to ensure the formed angle. 
     Aside from ensuring the deployment angle, β, of launch tube  18 , a distal portion of launch tube  18  may be modified to include an extended portion  382  which is configured to remain straight even when launch tube  18  is flexed into its deployment configuration, as shown in  FIG. 26A . Extended portion  382  may comprises an uncut portion of launch tube  18  or it may alternatively comprise a strengthened region of the launch tube  18 . In either case, the extended portion  382  may provide additional columnar support to needle body  380  during needle deployment from launch tube  18  to help ensure the linear deployment of the needle body  380  into or through the tissue. 
     Another variation for needle deployment from launch tube  18  may be seen in the cross-sectional views of  FIGS. 26B and 26C , which show the needle body  380  positioned within the distal portion  382  of launch tube  18 . To ensure deployment of needle body  380  in a perpendicular or desired trajectory, needle body  380  may define a cross-sectional shape, other than circular, which is keyed to the extended distal portion  382  of launch tube  18 . Thus, needle body  380  may define an elliptical cross-sectional shape within a complementary elliptically-shaped distal portion  384 , as seen in  FIG. 26B . Alternatively, needle body  380  may be configured into a polygonal shape, e.g., octagonal, within an octagonally-shaped distal portion  386 , as seen in  FIG. 26C . Any number of other cross-sectional shapes may be employed, e.g., rectangles, hexagons, heptagons, octagons, etc. 
     Rather than utilizing various cross-sectional shapes, needle body  390  may instead be keyed to launch tube  394  to ensure a specified deployment trajectory of needle body  390  from keyed launch tube  394 , as shown in the cross-sectional view of  FIG. 27A . One variation for keying may include attaching or forming a key or projection  392 , e.g., a length of wire, along one or more sides of needle body  390 , as shown in the side view of needle body  390  and delivery catheter  398 . Launch tube  394  may define a groove or channel  396  along an inner surface through which the key  392  on needle body  390  may travel within while maintaining an orientation of needle body  390  relative to launch tube  394 . 
     Yet another variation for ensuring needle trajectory from the launch tube may be seen in the partial cross-sectional view of  FIG. 28 . Various features of the tissue manipulation assembly have been omitted merely for clarity. As shown, launch tube  400  may be overdriven relative to the tissue manipulation assembly and upper extension member  20 , i.e., the angle, θ, formed between the deployed needle body  402  and upper extension member  20  is greater than 90°. The launch tube  400  and deployed needle body  402  may be overdriven to ensure that the trajectory of needle body  402  is directed towards the assembly rather than away from the assembly. 
     Any of the launch tube variations described herein is not intended to be limited to the examples described but is intended to be utilized in any number of combinations with other aspects of other variations as practicable. Moreover, any of the variations relating to the launch tube variations may also be used in any number of combinations, as practicable, with variations of other features as described above, if so desired. 
     Needle Body 
     Generally, the launch tube needle is preferably a hollow tapered needle body which is configured to pierce into and through tissue. The needle body may have a variety of tapered piercing ends to facilitate its entry into tissue. One variation which may be utilized to ensure the needle trajectory through the tissue may be seen in  FIG. 29A , which shows curved or curvable needle body  410  deployed from launch tube  18 . 
     In this variation, needle body  410  may be constrained into a straightened configuration when positioned within launch tube  18 . However, once deployed from launch tube  18 , needle body  410  may be adapted to reconfigure itself into a curved configuration directed towards the tissue manipulation assembly. Thus, curved needle body  410  may be made from a super elastic alloy or shape memory alloy such as Nitinol.  FIG. 29B  shows another variation in which curved needle body  410  may be launched from an under-deployed launch tube  412 . 
     Another variation for curving the needle body is illustrated in the side view of  FIG. 30 . In this variation, needle body  420  may be curved via an anvil  422  configured to receive and deflect the travel of needle body  420  into a curved needle body. Needle body  420  may be comprised of a super elastic alloy such as Nitinol. Anvil  422  may be mounted on either lower extension member  26 , as shown in the figure, or upper extension member  20 , depending upon the desired results. 
     Yet another variation of the needle body may be seen in the illustrative side view of  FIG. 31  where the needle body may be replaced with a fiber optic needle  430 . Such a needle  430  may be deployed through the launch tube  18  to provide visualization of the tissue region prior to, during, or after anchor deployment. Alternatively, fiber optic needle  430  may be advanced directly into or through the tissue region for visualization of the tissue. As shown, fiber optic needle  430  may be in communication via fiber optic wire or wires  432  to a processor  434  and an optional monitor  436  for viewing the tissue region from outside the patient&#39;s body. 
     In another alternative, advancement of the needle body into and/or through the tissue may be facilitated via an ultrasonic vibrating needle body  440 , as shown in  FIG. 32 : Vibrating needle body  440  may be electrically connected via wires  442  to power source  444  for driving the needle body, e.g., using a piezoelectric transducer to supply the vibratory motion. 
       FIG. 33  illustrates yet another alternative where rather than utilizing a vibrating needle body, a torqueable needle body  450 , which may be torqued about its proximal end, may be utilized to facilitate entry into the tissue. The torqueable needle body  450  may be connected via a catheter length having high-torque characteristics, e.g., via braiding along the catheter shaft. Moreover, needle body  450  may further define threading  452  over its outer surface to facilitate entry of the needle body  450  into the tissue. To remove the needle body  450  from the tissue, the direction of torque may simply be reversed while pulling proximally on needle body  450 . 
     Rather than deploying anchors from the needle assembly via a distal opening in the needle body, the tissue anchor may alternatively be deployed through one or more side openings defined proximally of the distal tip of the needle body. As seen in the detail view of alternative needle body  460  in  FIG. 34A , tissue anchor  60  may be deployed from needle body  460  through side opening  462 . A ramp or taper  464  may be defined within needle body  460  leading to side opening  462  to facilitate the ejection of the tissue anchors from needle body  460 .  FIG. 34B  shows another alternative needle body  466  having a side opening  462 . This variation, however, includes a. tapered needle body with needle knife  468  projecting distally from needle body  466 . Needle knife  468  may be utilized to facilitate the initial entry into the tissue while tapered needle body  466  may be used to dilate the opening created by needle knife  468  and facilitate the entry of needle body  466  into and/or through the tissue. 
     Another variation on the needle body and launch tube is shown in  FIGS. 35A to 36C .  FIG. 35A  shows an end view looking directly along tubular body  12  towards the tissue manipulation assembly with the launch tube  470  flexed into its deployment configuration.  FIGS. 35B and 35C  show the end view of  FIG. 35A  where the assembly is angled relatively to the left and to the right, respectively. The terms “U” and “right” are intended to refer only to the orientation of the assembly as shown in the figures and are used for illustrative purposes.  FIG. 36A  shows a top view of the assembly corresponding to  FIG. 35A  while  FIGS. 36B and 36C  also show top views corresponding to  FIGS. 35B and 35C , respectively. When the tissue assembly is visualized within the patient&#39;s body via a laparoscope or endoscope, determining the orientation of the assembly with respect to the tissue may at times be difficult typically due to the lack of depth perception. Thus, to aid with orientation of the assembly when oriented at some angle, w, as shown in  FIGS. 35B, 35C, 36B and 36C , portions of the assembly, such as launch tube  470  or the needle assembly, may be coated or covered with a color, e.g., red, orange, yellow, green, blue, indigo, violet, silver, black, or combinations thereof. The aid of coloring portions of the assembly may help with gaining orientation of the device. 
     Aside from coloring the tissue manipulation assembly, portions of the needle assembly may also be colored as well.  FIG. 37A  shows a needle body  480  which may be colored with any of the colors described above to facilitate orientation of the needle body  480  when deployed from the launch tube. In another alternative, needle body  482  may have gradations or indicators  484  along its surface, as shown in  FIG. 37B , to provide a visual indication to the surgeon or physician of the position of needle body  482  when advanced into or through the tissue or when deployed from the launch tube. Each of the gradations  484  may be separated by a uniform distance or various positions along the needle body  482  may be marked to indicate specified locations. 
       FIG. 37C  shows yet another variation in which the outer surface of needle body  486  may be dimpled  488 . The presence of dimples  488  may be used to enhance the visualization of needle body  486  within the patient body. Moreover, dimples  488  may also enhance the visualization of needle body  486  under ultrasound imaging, if utilized, either for imaging the position of needle body  486  or for locating needle body  486  within the patient&#39;s body if the needle body  486  were to inadvertently break off. 
     Yet another variation is shown in the cross-sectional view of needle body  490  in  FIG. 37D . The outer surface of needle body  490  may be coated or covered with a radio-opaque material  492  to further enhance visualization or the needle body  490 , for example, if x-ray or fluoroscopic imaging were utilized. The radio-opaque coating  492 , e.g., platinum, nickel, etc., may also be further coated with a lubricious material to facilitate needle insertion into and/or through the tissue. 
     Any of the needle body and needle assembly variations described herein is not intended to be limited to the examples described but is intended to be utilized in any number of combinations with other aspects of other variations as practicable. Moreover, any of the variations relating to the needle body variations may also be used in any number of combinations, as practicable, with variations of other features as described above, if so desired. 
     Handle Assembly 
     The tissue manipulation assembly may be manipulated and articulated through various mechanisms. One such assembly which integrates each of the functions into a singular unit may be seen in the handle assembly which is connected via tubular body  12  to the tissue manipulation assembly. Such a handle assembly may be configured to separate from tubular body  12 , thus allowing for reusability of the handle. Moreover, such a handle may be fabricated from a variety of materials such as metals or plastics, provided that the materials are preferably biocompatible. Examples of suitable materials may include stainless steel, PTFE, Delrin® etc. 
     One variation of a handle assembly is shown in the illustrative side view of handle  500  in  FIG. 38A  with half of handle enclosure  502  removed for clarity for discussion purposes. As shown, handle enclosure  502  may connect with tubular body  12  at its distal end at tubular interface  504 . The proximal end of handle  500  may define acquisition member opening  506  which opens to acquisition member receiving channel  508  defined through enclosure  502  from opening  506  to tubular interface  504 . The acquisition member  28  may be routed through receiving channel  508  with the proximal end  510  of acquisition member  28  extending proximally of enclosure  502  for manipulation by the user. Acquisition member proximal end  510  may further have an acquisition member rotational control  512  that the user may grasp to manipulate acquisition member  28 . 
     Acquisition member receiving channel  508  preferably has a diameter which is sufficiently large enough to allow for the translational and rotational movement of acquisition member through the receiving channel  508  during tissue manipulation. Acquisition member lock  524 , e.g., a screw or protrusion, may also extend at least partially into acquisition member receiving channel  508  such that lock  524  may be urged selectively against acquisition member  28  to freeze a position of acquisition member  28 , if so desired. The terminal end of receiving channel  508  may extend to tubular interface  504  such that receiving channel  508  and tubular body  12  are in communication to provide for the passage of acquisition member  28  therethrough. 
     In addition to the acquisition member controls, the handle enclosure  502  may also provide a needle assembly receiving channel  514  through which needle assembly control  516  and needle assembly catheter  518  may be translated through. Needle assembly receiving channel  514  may extend from needle assembly opening  520  also to tubular interface  504 . Needle assembly receiving channel  514  extends to tubular interface  504  such that needle assembly receiving channel  514  and tubular body  12  are also in communication to provide for the passage of needle assembly catheter  518  therethrough. 
     In operation, once the tissue to be plicated has been acquired and drawn between the lower and upper extension members by acquisition member  28 , as described above, the launch tube  18  may be advanced distally and rotated into its deployment configuration. Once positioned for deployment, the needle assembly may be advanced into and/or through the tissue by urging needle assembly control  516  and needle assembly catheter  518  distally into needle assembly receiving channel  514 , as shown by the advancement of control  516  in  FIG. 38B . The tissue anchors may then be deployed from the needle assembly catheter  518  via the needle assembly control  516 , as further described below. Withdrawal of the needle assembly from the tissue may be accomplished by the proximal withdrawal of needle assembly control  516  and assembly catheter  518 . 
     Tissue manipulation articulation control  522  may also be positioned on handle  500  to provide for selective articulation of the tissue manipulation assembly, as shown above in  FIGS. 23A to 23C . This variation shows articulation control  522  rotatably positioned on handle enclosure  502  such that articulation control  522  may be rotated relative to handle  500  to selectively control the movement of the tissue manipulation assembly. Articulation control  522  may be operably connected via one or several control wires attached between articulation control  522  and the tissue manipulation assembly. The control wires may be routed through tubular interface  504  and extend through tubular body  12 . 
       FIG. 38C  shows another variation of handle enclosure  502  where the tissue manipulation articulation control  526  may be positioned on a side surface of handle enclosure  502 . Articulation control  526  may include a ratcheting mechanism  528  within enclosure  502  to provide for controlled articulation of the tissue manipulation assembly. 
       FIGS. 39A to 39C  show top, side, and cross-sectional views, respectively, of another variation on the handle assembly. As seen in  FIGS. 39A and 39B , an advancement control  530  may be adapted to selectively slide translationally and rotationally through a defined advancement channel or groove  532  defined within handle enclosure  502 . Advancement control  530  may be used to control the deployment and advancement of needle assembly control  516  as well as deployment of the launch tube, as described in further detail below. 
       FIG. 39D  shows an assembly side view of the handle assembly, tubular body  12 , and tissue manipulation assembly and the corresponding motion of the assembly when manipulated by the handle. As described above, tissue acquisition member proximal end  510  and acquisition member control  512  may be advanced or withdrawn from the handle enclosure  502  in the direction of arrow  534  to transmit the corresponding translational motion through tubular body  12  to tissue acquisition member  28  and tissue grasper  30 , as indicated by the direction of corresponding arrow  536 . Likewise, when acquisition member control  512  is rotated relative to handle enclosure  502 , as indicated by rotational arrow  538 , the corresponding rotational motion is transmitted through tubular body  12  to tissue grasper  30  for screwing into or unscrewing from tissue, as indicated by corresponding rotational arrow  540 . As mentioned above, tubular body  12  may be rigid or flexible depending upon the application utilized for the device. 
     Likewise, longitudinal translation of needle assembly control  516  relative to enclosure  502 , as indicated by the arrow may transmit the corresponding longitudinal motion to the needle assembly through the launch tube when reconfigured for deployment. The tissue manipulation assembly articulation control  522  may also be seen in this handle variation as being rotatable in the direction of arrow  542  relative to handle enclosure  502 . Depending upon the direction of articulation, control  522  may be manipulated to elicit a corresponding motion from the tissue manipulation assembly about hinge or articulatable section  350  in the direction of arrows  544 . 
     Another handle variation may be seen in the perspective view of handle assembly  550 , as shown in  FIG. 40A . This particular variation may have handle enclosure  552  formed in a tapered configuration which allows for the assembly  550  to be generally symmetrically-shaped about a longitudinal axis extending from its distal end  554  to its proximal end  556 . The symmetric feature of handle assembly  550  may allow for the handle to be easily manipulated by the user regardless of the orientation of the handle enclosure  552  during a tissue manipulation procedure. An additional feature which may further facilitate the ergonomic usability of handle assembly  550  may further include at least one opening  558  defined through the enclosure  552  to allow the user to more easily grip and control the handle  550 . Another feature may include grips  560 ,  562  which may extend from either side of enclosure  552 . 
     As seen in the figure, acquisition member  564  may include additional features to facilitate control of the tissue. For instance, in this variation, in addition to the rotational control  566 , an additional rotational control  568  may extend proximally from control  566  and have a diameter smaller than that of control  566  for controlling fine rotational motion of acquisition member  564 . 
       FIG. 40B  shows a side view of the handle assembly  550  of  FIG. 40A  with the enclosure  552  partially removed for clarity. As shown, needle assembly control  570  may be seen inserted within an additional needle deployment mechanism  576 , as described below in further detail, within needle assembly receiving channel  574 . Acquisition member  564  may also be seen positioned within acquisition member receiving channel  572 . 
     Yet another variation of the handle assembly may be seen in the side view of the handle assembly of  FIG. 41A  where the handle enclosure  522  is partially removed for clarity. In this variation, needle deployment mechanism lock  580 , e.g., a screw or protrusion, may be configured to operably extend at least partially into needle assembly receiving channel  574  to selectively lock the launch tube and/or needle assembly control within receiving channel  574 . Also shown is acquisition member receiving channel  582  through which the acquisition member may be translated and/or rotated. Acquisition member lock  584  may also be seen to extend at least partially into the acquisition member receiving channel  582  to selectively lock the acquisition member position, if so desired. The acquisition member receiving channel  582  may be optionally threaded  586  such that the acquisition member may be advanced or withdrawn using a screw-like mechanism. 
     An additional needle deployment mechanism lock  594  may also be seen pivotally mounted about pivot  596  within enclosure  522 . Mechanism  594  may be biased via deployment mechanism biasing element  598 , e.g., a spring, to maintain a biasing force against mechanism  594  such that the needle assembly control may automatically become locked during advancement within enclosure  522  to allow for a more controlled anchor deployment and needle assembly advancement. 
     Moreover, one or more pivotable tissue manipulation assembly controls  588  may be mounted to enclosure  522  and extend from one or both sides of enclosure  522  to provide for articulation control of the tissue manipulation assembly, as described above. As presently shown in  FIG. 41B  in the detail side view from the handle assembly of  FIG. 41A , one or more control wires  592  may be connected to control  588  at control wire attachment points  600 . Control  588  may pivot about tissue acquisition pivot  590  located within handle enclosure  522 . As control  588  is pivoted, the articulation of control wires  592  may articulate a position of the tissue manipulation assembly, as discussed above.  FIG. 41B  shows an example of the range of motion which may be possible for control  588  as it is rotated about pivot  590 . 
       FIG. 42A  shows a side view of another variation of handle enclosure  610  which incorporates a needle deployment locking and advancement control  612  which is adapted to be advanced and rotated within needle deployment travel  614  into various positions corresponding to various actions. Locking control  612  may be utilized in this variation to selectively control access of the needle assembly within handle enclosure  610  as well as deployment of the needle assembly and launch tube advancement with a single mechanism. A needle assembly, such as needle assembly  570 , may be advanced into handle enclosure  610  with locking control  612  initially moved into needle assembly receiving position  616 , shown also in the end view of  FIG. 42B . Once the needle assembly has been initially introduced into enclosure  610 , the needle assembly may be locked within enclosure  610  by rotating locking control  612  into its needle assembly locking position  618 , clockwise rotation as shown in the end view of  FIG. 42C . The needle assembly may be locked within enclosure  610  to prevent the accidental withdrawal of the needle assembly from the enclosure  610  or inadvertent advancement of the needle assembly into the tissue. 
     With locking control  612  in the needle assembly locking position  618 , the needle deployment mechanism within enclosure  610  may also be longitudinally translated in a distal direction by urging locking control  612  distally within needle deployment travel  614 . Urging locking control  612  distally translates not only the needle deployment mechanism within enclosure  610 , but may also translate the launch tube distally such that the launch tube distal portion is pivoted into its deployment configuration, as described above. As the needle deployment mechanism is distally translated within enclosure  610 , the needle assembly may also be urged distally with the deployment mechanism such that needle assembly becomes positioned within the launch tube for advancing the needle body into the tissue. 
     Once locking control  612  has been advanced distally, locking control  612  may again be rotated into the needle assembly release position  620 , clockwise rotation as shown in the end view of  FIG. 42D . Once in the release position  620 , the needle assembly may be free to be translated distally within enclosure  610  for advancing the needle assembly and needle body relative to the launch tube and enclosure  610 . To remove the needle assembly from enclosure  610 , the steps may be reversed by moving locking control  612  proximally back to its initial needle assembly receiving position  616  so that the needle assembly is unlocked from within enclosure  610 . A new needle assembly may then be introduced into enclosure  610  and the process repeated as many times as desired. 
     Details of one variation of the locking mechanism disposed within the handle enclosure  610  are shown in the perspective view of  FIG. 43A . The other elements of the handle assembly have been omitted from this illustration for clarity. The locking mechanism may generally be comprised of outer sleeve  630  disposed about inner sleeve  632 . Outer sleeve  630  preferably has a diameter which allows for its unhindered rotational and longitudinal movement relative to inner sleeve  632 . Needle deployment locking control  612  may extend radially from outer sleeve  630  and protrude externally from enclosure  610 , as described above, for manipulation by the user. Outer sleeve  630  may also define needle assembly travel path  636  along its length. Travel path  636  may define the path through which needle assembly  570  may traverse in order to be deployed. Needle assembly  570  may define one or more guides  638  protruding from the surface of assembly  570  which may be configured to traverse within travel path  636 . Inner sleeve  634  may also define guides  634  protruding from the surface of inner sleeve  634  for traversal within grooves defined in handle enclosure  610 . Moreover, outer sleeve  630  is preferably disposed rotatably about inner sleeve  632  such that outer sleeve  630  and inner sleeve  632  are configured to selectively interlock with one another in a corresponding manner when locking control  612  is manipulated into specified positions. 
     Turning to  FIGS. 43B to 43E , the operation of the locking mechanism of  FIG. 43A  is described in further detail. As needle assembly  570  is initially introduced into handle enclosure  610  and the locking mechanism, needle assembly  570  may be rotated until guides  638  are able to slide into longitudinal receiving channel  640  of travel path  636  defined in outer sleeve  630 , as shown in  FIGS. 43B and 43C . Locking control  612  may be partially rotated, as described above in  FIGS. 42B and 42C , such that outer sleeve is rotated with respect to needle assembly  570  and guides  638  slide through transverse loading channel  642 , as shown in  FIG. 43D . In this position, the locking mechanism may be advanced distally to deploy the launch tube and to also advance needle assembly  570  distally in preparation for needle assembly  570  deployment. Once the launch tube has been desirably advanced, locking control  612  may again be partially rotated, as shown in  FIG. 42D , such that guides  638  on needle assembly  570  are free to then be advanced within longitudinal needle assembly channel  644  relative to the handle enclosure  610  for deploying the needle assembly  570  from the launch tube and into or-through the tissue. As mentioned above, the needle assembly  570  may be removed from enclosure  610  and the locking mechanism by reversing the above procedure. 
     As above, any of the handle assembly variations described herein is not intended to be limited to the examples described but is ‘mended to be utilized in any number of combinations with other aspects of other variations as practicable. Moreover, any of the variations relating to the handle assembly variations may also be used in any number of combinations, as practicable, with variations of other features as described above, if so desired. 
     Needle Deployment Assembly 
     As described above, needle deployment assembly  650  may be deployed through approximation assembly  10  by introducing needle deployment assembly  650  into the handle  16  and through tubular body  12 , as shown in the assembly view of  FIG. 44 , such that the needle assembly  656  is advanced from the launch tube and into or through approximated tissue. Once the needle assembly  656  has been advanced through the tissue, the anchor assembly  658  may be deployed or ejected. Anchor assembly  658  is normally positioned within the distal portion of tubular sheath  654  which extends from needle assembly control or housing  652 . Once the anchor assembly  658  has been fully deployed from sheath  654 , the spent needle deployment assembly  650  may be removed from approximation assembly  10 , as described above, and another needle deployment assembly may be introduced without having to remove assembly  10  from the patient. The length of sheath  654  is such that it may be passed entirely through the length of tubular body  12  to enable the deployment of needle assembly  656  into and/or through the tissue. 
       FIG. 45A  shows a detailed assembly view of the needle deployment assembly  650  from  FIG. 44  in this variation, elongate and flexible sheath or catheter  654  may extend removably from needle assembly control or housing  652 . Sheath or catheter  654  and housing  652  may be interconnected via interlock  660  which may be adapted to allow for the securement as well as the rapid release of sheath  654  from housing  652  through any number of fastening methods, e.g., threaded connection, press-fit, releasable pin, etc. Needle body  662 , which may be configured into any one of the variations described above, may extend from the distal end of sheath  654  while maintaining communication between the lumen of sheath  654  and needle opening  664 . 
     Elongate pusher  666  may comprise a flexible wire or hypotube which is translationally disposed within sheath  654  and movably connected within housing  652 . A proximally-located actuation member  668  may be rotatably or otherwise connected to housing  652  to selectively actuate the translational movement of elongate pusher  666  relative to sheath  654  for deploying the anchors from needle opening  664 . Anchor assembly  658  may be seen positioned distally of elongate pusher  666  within sheath  654  for deployment from sheath  654 . Needle assembly guides  670  may also be seen protruding from housing  652  for guidance through the locking mechanism described above.  FIG. 45B  shows an exploded assembly view of the needle deployment assembly  650  from  FIG. 45A . As seen, sheath  654  may be disconnected from housing  652  via interlock  660  to reveal the elongate pusher  666  connected to housing  652  and the distal and proximal anchors  58 ,  60 , respectively, of anchor assembly  658 . 
       FIGS. 46A and 46B  show partial cross-sectional views of one variation of housing  652 . As shown in  FIG. 46A , elongate pusher  666  may be attached to shuttle  682 , which in turn may be connected to threaded interface element  686 . As actuation member  668  is manipulated, e.g., by rotating it clockwise, lead screw  684  may be rotated about its longitudinal axis to advance threaded interface element  686  over lead screw  684  distally through shuttle channel  680 , as shown in  FIG. 46B , where shuttle  682  has been advanced entirely through shuttle channel  680 . Tubular sheath interlock  688  may be seen at the distal portion of housing  652  through which the elongate pusher  666  may be advanced. To reverse the direction of elongate pusher  666  and shuttle  682 , actuation member  66 S may be reversed in the opposite direction. 
     Another variation of the needle deployment assembly may be seen in  FIGS. 47A and 47B  which show assembly side views. In this variation, housing  652  may define an indicator window  690  along the length of housing  652  to enable viewing of a visual indicator  692  which may be utilized to indicate the position of the elongate pusher  666  within the sheath  654 . In the illustration of  FIG. 47A , as actuation member  668  is manipulated to advance pusher  666  distally, indicator  692  may move correspondingly within window  690 . Positional indicators may also be marked along window  690  to indicate to the user when specified limits have been reached. For instance, positional indicator  694  may be marked such that alignment of indicator  692  with positional indicator  694  is indicative to the user that distal anchor  58  has been deployed from sheath  654 . 
     Likewise, an additional positional indicator  696  may be marked such that alignment of indicator  692  with positional indicator  694  is indicative to the user that the proximal anchor  60  has also been deployed from sheath  654 , as shown in  FIG. 47B . Any number of positional indicators or methods for visually marking may be utilized as the above examples are merely intended to be illustrative and not limiting. Moreover, to further facilitate the visualization of anchor positioning within sheath  654 , the sheath itself may be fabricated from a transparent material, such as plastics, so that the user may visually locate a position of one or both anchors during anchor deployment into or through the tissue. 
       FIG. 47C  shows an illustrative cross-sectional view of the launch tube  18  in its deployment configuration. Tubular sheath  654  and needle body  662  may be seen positioned within the distal portion of launch tube  18  ready for deployment into any tissue (not shown for clarity) which may be positioned between upper and lower extension members  20 ,  26 . Also shown are distal and proximal anchors  58 ,  60 , respectively (suture is not shown for clarity), positioned within sheath  654  distally of elongate pusher  666 . 
       FIG. 48  shows an assembly view of yet another variation in which manipulatable needle assembly  700  may be utilized with approximation assembly  10 . Similar to the assembly above, manipulatable needle assembly  700  may be deployed through approximation assembly  10  by introducing needle assembly  700  into the handle  16  and through tubular body  12 . Once the needle assembly has been advanced through the tissue, an anchor assembly may be deployed or ejected and/or the tissue or suture may be manipulated via the assembly  700 . A further detailed description of manipulatable needle assembly  700  is disclosed in co-pending U.S. patent application Ser. No. 10/898,684, filed Jul. 23, 2004 and entitled “Manipulatable Grasping Needle”, which is incorporated herein by reference in its entirety. 
     As shown in  FIG. 48 , an elongate flexible member  702  may be tubular such that at least one lumen is defined through the length of flexible member  702 . Handle  704  may be positioned at a proximal end of flexible member  702  and control handle  706  may be likewise positioned. Control handle  706  may be configured to enable the articulation of piercing and grasping assembly  708  into an open or closed configuration, as described in further detail below. Control handle  708 , as well as handle  704  which is positioned at a distal end of flexible member  702 , may be operably connected to piercing and grasping assembly  708 , e.g., via control wires, which may run through the length of flexible member  702 . 
     Flexible member  702  may be made from a variety of flexible materials such as polymers. If made from a polymeric material, flexible member  702  may be reinforced along its length as necessary using various methods such as interspersing metallic braids, weaves, reinforcing wires, etc., throughout the length of the flexible member  702 . Alternatively, metallic materials, e.g., stainless steel, platinum, etc., and particularly superelastic metals and alloys, e.g., Nitinol, etc., may be utilized in constructing flexible member  702  provided that the material is sufficiently adapted to flex when manipulated. In the case of stainless steel or like metals, the length of flexible member  702  may be scored or perforated to allow for additional flexibility. Moreover, the diameter of flexible member  702  may be varied to suit the application in which assembly  700  may be employed. For example, if assembly  700  were advanced, e.g., through a conventional endoscope for use in a patient&#39;s stomach, flexible member may range anywhere in diameter from 2-3 mm and may have a length greater than or less than 100 cm. These dimensions are merely intended to be illustrative and are not intended to limit the size or scope of the assembly  700 . 
     As generally shown, piercing and grasping assembly  708  may be comprised of needle body  710 , which has a tapered or sharpened tip  712  for piercing into or through tissue. Needle body  710  may also define an opening or lumen  714  therethrough for retaining and passing a tissue anchor, as described further below. As seen in the detail side view of  FIG. 49A , piercing and grasping assembly  708  may be configured into a low-profile closed configuration for advancement into the body and for piercing into or through tissue. As piercing and grasping assembly  708  is advanced into or through tissue, a length of suture  720  may be releasably retained by assembly  708  between needle body  710  and grasping arm  716 , which may be positioned proximally of tip  712  and/or needle body  710 . 
     Once piercing and grasping assembly  708  has been desirably advanced into or through tissue, assembly  708  may be actuated into an open configuration where grasping arm  716  may project from needle body  710 , as shown in  FIG. 49B . In the open configuration, grasping arm  716  may be open relative to needle body  710  such that suture  720  may be released from piercing and grasping assembly  708 . Alternatively, piercing and grasping assembly  708  may be manipulated to grasp a free length of suture. Linkage assembly  718 , which may be actuated via a push and/or pull wire (not shown) contained within tubular member  702 , may be used to open and close needle body  710  and grasping arm  716 . As shown, both needle body  710  and grasping arm  716  may each be actuated into an opened configuration relative to tubular member  702 ; alternatively, linkage assembly  718  may be utilized to actuate a single member, i.e., needle body  710  or grasping arm  716 , into an opened configuration for suture manipulation or release. 
     Elongate tubular member  702  may be flexible or it may also be constructed as a rigid shaft. In either case, one or several portions of elongate member  702  may comprise an articulatable section  30  along a length of elongate member  702 . A section of member  702  just proximal of piercing and grasping assembly  708  may be configured to be articulatable such that assembly  708  may be articulated via handle  704 . One or several control wires may be routed through elongate member  702  in any number of ways to enable articulatable section  30  to conform to a desired shape. An elongate member  702  having one or several articulatable sections  30  may enable assembly  708  to be manipulated about or around tissue such that suture manipulation is facilitated. 
     The piercing and grasping assembly  708  may be utilized in a variety of different procedures. In one instance, assembly  708  may be advanced into a hollow body organ, e.g., a stomach and used to pierce through created tissue plications and deposit soft tissue anchors for securing the tissue plications. Examples of methods and devices for creating tissue plications may be seen in further detail in U.S. patent application Ser. No. 10/735,030 which has been incorporated by reference above. As shown in  FIG. 50A , an expandable tissue anchor  722  may be seen positioned within opening  714  of needle body  710  for delivery. Suture  720  ending in terminal loop  724  may be seen passing through and from tissue anchor  722 . Once assembly  708  has been desirably passed through tissue and appropriately positioned, tissue anchor  722  may be ejected from needle body  710 , e.g., using a pusher mechanism. Once free from the constraints of needle body  710 , tissue anchor  722  may be free to expand for anchoring against a tissue surface, as seen in  FIG. 50B . Further details relating to tissue anchors and mechanisms which may be utilized for ejecting and positioning such anchors are disclosed in further detail in U.S. patent application Ser. No. 10/840,950 filed May 7, 2004, which has been incorporated herein by reference above in its entirety. 
     As above, any of the needle assembly variations described herein is not intended to be limited to the examples described but is intended to be utilized in any number of combinations with other aspects of other variations as practicable. Moreover, any of the variations relating to the needle assembly variations may also be used in any number of combinations, as practicable, with variations of other features as described above, if so desired. 
     Anchor Deployment 
     In deploying the anchors into or through the tissue, one or more anchors may be positioned within the launch tube for deployment. As described above, deployment of the anchors may be accomplished in one method by pushing the anchors via the elongate pusher element until the anchor is ejected from the needle body opening. Once the anchor is free from the constraints of the needle catheter, it may reconfigure into an expanded configuration for placement against the tissue surface. 
     To ensure that the anchor is not prematurely ejected from the needle assembly, various interlocking features or spacing elements may be employed. As shown in the partial cross-sectional view of  FIG. 51A , the collar of proximal anchor  60  and the distal end of elongate pusher may be interlocked with one another via a temporary interlocking feature  730 . Likewise, the adjacent collars of distal and proximal anchors  58 ,  60 , respectively, may be optionally interlocked with one another via a temporary interlocking feature  732  as well. Such an interlocking feature may enable the anchor assembly to be advanced distally as well as withdrawn proximally through sheath  654  and needle body  662  in a controlled manner without the risk of inadvertently pushing one or more anchors out of needle body  662 . 
     Aside from the use of interlocking features, one or more spacing elements  734  may also be placed between adjacent anchors within sheath  654  in another variation as shown in  FIG. 51C . In use, as distal anchor  58  is initially deployed, spacer  734  may provide additional distance between the adjacent anchors so that proximal anchor  60  is not inadvertently deployed along, with distal anchor  58 . Spacer element  734  may optionally include interlocking features to temporarily interlock with the adjacent anchors. Moreover, when proximal anchor  60  is deployed, spacer element  734  may be ejected into the patient&#39;s body, e.g., the stomach, to simply degrade or pass naturally from the patient. Accordingly, such a spacer  734  is preferably made from any number of biocompatible and/or biodegradable materials. 
     Aside from the interlocking anchor features, the suture  76  which may be routed through anchors  58 ,  60  to interconnect them may also be varied in placement with respect to the anchors. As shown in  FIG. 51A , suture  76  may be optionally routed such that its terminal end is deployed initially with distal anchor  58 . Alternatively, suture  76  may be routed such that its terminal end is deployed lastly along with proximal anchor  60 . Other variations for routing the suture  76  may be employed as practicable as the foregoing examples are described merely as examples and are not intended to be limiting in their description. 
     Turning back to the anchor interlocking features,  FIGS. 52A and 52B  show perspective views of distal anchor  58  and proximal anchor  60 , respectively, having one variation for temporarily interlocking the anchors. The anchors  58 ,  60  are shown in their unexpanded delivery configuration when positioned within the tubular delivery sheath or catheter  654 . As shown, the proximal collar of distal anchor  58  may have a circumferential-tab locking feature  744 , as shown in  FIG. 52A , which is configured to inter-fit in a complementary manner with circumferential-tab locking feature  742  on proximal anchor  60 , as shown in  FIG. 52B . Likewise, the proximal collar of proximal anchor  60  may also have a circumferential-tab locking feature  740  which is configured to inter-fit also in a complementary manner with the locking feature  746  located on the distal end of elongate pusher  666 , as shown in the detail perspective view of  FIG. 52C . 
       FIGS. 53A and 53B  show another variation on the interlocking feature where the anchor may have a longitudinal-tab locking feature  750  or a receiving-tab locking feature  752  which is configured to inter-fit with one another in a complementary manner.  FIG. 53B  shows the distal end of an elongate pusher variation having a longitudinal-tab locking feature  754  for inter-fitting with the proximal collar of an adjacent anchor. 
     With any of the interlocking features described herein, they are preferably configured to temporarily lock adjacent anchors and/or the anchor to the elongate pusher to one another. The positioning and orientation of the adjacent anchors and elongate pusher may be such that the abutting ends of each are configured to remain interlocked with one another when constrained by the inner surface of the sheath  654 . However, when an anchor is ejected from the constraints of the sheath  654  and the alignment of the anchors is skewed, the interlocking feature is preferably adapted to thus unlock itself and thereby release the ejected anchor. 
       FIG. 54A  shows another variation on a curved-tab interlocking feature  760 .  FIG. 54B  shows distal and proximal anchors  58 ,  60 , respectively, interlocked via the curved-tab feature  760  when constrained in the sheath  65   1 .  FIG. 54C  shows distal anchor  58  having been ejected and released from the interlocking feature  760 . The interlocking feature is not shown on the proximal end of proximal anchor  60  and other features such as the elongate pusher and suture have been omitted merely for the sake of clarity. 
       FIGS. 55A, 55B, and 55C  likewise show angled interlocking feature  770  in a detail view, between adjacent anchors, and with distal anchor  58  being released from the interlocking feature  770 , respectively. 
       FIGS. 56A, 56B, and 56C  likewise show interlocking feature  780  having a tab  782  and a complementary receiving groove  784  in a detail view, between adjacent anchors, and with distal anchor  58  being released from the interlocking feature  780 , respectively.  FIGS. 57A, 57B, and 57C  likewise show interlocking feature  790  having a pin  792  and a complementary receiving groove  794  in a detail view, between adjacent anchors, and with distal anchor  58  being released from the interlocking feature  790 , respectively.  FIGS. 58A, 58B, and 58C  likewise show rotational interlocking feature  800  having a helix or coil  802  and a complementary inter-fitting pin  804  in a detail view, between adjacent anchors, and with distal anchor  58  being released from the interlocking feature  800 , respectively. 
       FIGS. 59A, 59B, and 59C  likewise show electrolytic interlocking feature  810  having an inter-joined electrolytically-erodable joint  812  in a detail view, between adjacent anchors, and with distal anchor  58  being released from the interlocking feature  780 , respectively. The electrolytically-erodable joint  812  may be electrically connected via wires (not shown) routed through sheath  654  to a power source located outside the patient. For release of the anchor, the electrolytically-erodable  812  may be eroded and leave eroded joint ends  814 ,  816  on adjacent anchors. 
       FIGS. 60 .A,  60 B, and  60 C likewise show interlocking feature  820  having a balled joint  822  and a complementary receiving groove  824  in a detail view, between adjacent anchors, and with distal anchor  58  being released from the interlocking feature  820 , respectively. 
       FIGS. 61A, 61B, and 61C  likewise show balled interlocking feature S 30  in a detail view, between adjacent anchors, and with distal anchor  58  being released from the interlocking feature  830 , respectively. Each of the respective ball joints  832 ,  834  are configured to inter-fit with complementary receiving grooves  836 ,  838  on adjacent anchors. 
       FIGS. 62A, 62B, and 62C  likewise show magnetic locking feature  840  having respective anchors ends  842 ,  844  with opposing polarities in a detail view, between adjacent anchors, and with distal anchor  58  being released from the magnetic locking feature  840 , respectively. Each of the magnets  842 ,  844  may be comprised of ferromagnetic materials, or they may be electromagnetically charged. 
       FIG. 63  shows yet another variation which may be utilized particularly between an anchor and the elongate pusher. The interlocking feature  850  may comprise a curved or arcuate feature, e.g., circumferential-tab locking feature  744 , which may receive a cross-member  854  extending perpendicularly from elongate member  852 . 
       FIG. 64A  shows yet another variation where elongate pusher  666  may have one or several biased retaining arms  860 ,  862  extending from the distal end of pusher  666 . Retaining arms  860 ,  862  may be biased to extend radially but may be constrained to extend radially inward when positioned within sheath  654 . The distal ends of arms  860 ,  862  may protrude inwardly between the struts of the anchor  60  for manipulation and deployment. When pusher  666  is advanced distally, arms  860 ,  862  may spring radially open to thereby release anchor  60 . The proximal portions of arms  860 ,  862  may be tapered such that when pusher  666  is withdrawn proximally into sheath  654 , the taper on each of the arms  860 ,  862  allows them to be drawn back into sheath  654 . 
       FIG. 64B  shows another variation in which extension member  864  may extend distally from elongate pusher  666  to form at least one retaining arm  866  which may extend between one or more adjacent anchors  58 ,  60 . As pusher  666  is advanced distally, proximal anchor  60  may be released when retaining arm  866  is fully advanced outside of sheath  654  and needle body  662 . 
       FIG. 64C  shows yet another variation where the proximal anchor  60  may be retained to pusher  666  via a looped member  868  extending from the distal end of pusher  666 . Looped member  868  may simply be looped about the proximal end of proximal anchor  60  and released by simply advancing anchor  60  out of sheath  654 . 
     In utilizing any of the interlocking features described herein, needle assemblies may be utilized having multiple anchors for deployment into or through tissue.  FIG. 65  shows a partial cross-sectional view of multi-anchor variation  870  in which multiple anchors  872  may be aligned adjacently to one another in series within the sheath  654 . Each of the anchors  872  may be temporarily interlocked with one another such that each anchor  872  may be deployed sequentially in a controlled manner. 
       FIGS. 66A and 66B  show partial cross-sectional side and bottom views of yet another multi-anchor variation  880 . In this variation, sheath  882  may comprise a multi-tabbed assembly having multiple retaining tabs  884  extending partially into the sheath lumen. Each of the tabs  884  may be spaced uniformly relative to one another such that a single anchor  872  may be retained by a single tab  884 , as shown in the  FIG. 66A . As pusher  666  advances distally, each of the anchors, with or without interlocking features between adjacent anchors, may be advanced past a tab  884  until the desired number of anchors  872  has been deployed. Each tab  884  is preferably configured to extend only partially into the lumen, as mentioned and as shown in the cross-sectional view of  FIG. 66C , and is preferably configured to flex and thereby allow for passage of an anchor  872 . 
     Although a number of illustrative variations are described above, it will be apparent to those skilled in the art that various changes and modifications may be made thereto without departing from the scope of the invention. Moreover, although specific configurations and applications may be shown, it is intended that the various features may be utilized in various types of procedures in various combinations as practicable. It is intended in the appended claims to cover all such changes and modifications that fall within the true spirit and scope of the invention.