Abstract:
A method of implanting a device to maintain a plication within a hollow organ. The method uses an elongated member having an end effector at its distal end. The end effector has an outer cylinder having at least one opening, and an inner cylinder having at least one opening. The inner cylinder is at least partially disposed within the outer cylinder and the cylinders are rotatable with respect to each other. The end effector is detachable from the elongated member such that it can remain within the body cavity. The method involves the step of inserting the end effector within the organ of a patient such that it is in contact with tissue. The method also involves the step of applying vacuum through the elongated member so as to dispose tissue within the inner cylinder. The method also involves the step of creating a plication by rotating the cylinders with respect to each other. The method also involves the step of detaching the end effector from the elongated member.

Description:
FIELD OF THE INVENTION 
     The present invention relates in general to a bariatric treatment method and, more particularly, to a method for transorally plicating and fastening areas of gastric tissue to achieve a gastric volume reduction. 
     BACKGROUND OF THE INVENTION 
     The percentage of the world&#39;s population suffering from morbid obesity is steadily increasing. Severely obese persons are susceptible to increased risk of heart disease, stroke, diabetes, pulmonary disease, and accidents. Because of the effect of morbid obesity to the life of the patient, methods of treating morbid obesity are being researched. 
     Numerous non-operative therapies for morbid obesity have been tried with virtually no permanent success. Dietary counseling, behavior modification, wiring a patient&#39;s jaws shut, and pharmacological methods have all been tried, and failed to correct the condition. Mechanical apparatuses for insertion into the body through non-surgical means, such as the use of gastric balloons to fill the stomach have also been employed in the treatment of the condition. Such devices cannot be employed over a long term, however, as they often cause severe irritation, necessitating their periodic removal and hence interruption of treatment. Thus, the medical community has evolved surgical approaches for treatment of morbid obesity. 
     Most surgical procedures for treatment of morbid obesity may generally be classified as either being directed toward the prevention of absorption of food (malabsorption), or restriction of stomach to make the patient feel full (gastric restriction) The most common malabsorption and gastric restriction technique is the gastric bypass. In variations of this technique, the stomach is horizontally divided into two isolated pouches, with the upper pouch having a small food capacity. The upper pouch is connected to the small intestine, or jejunum, through a small stoma, which restricts the processing of food by the greatly reduced useable stomach. Since food bypass much of the intestines, the amount of absorption of food is greatly reduced. 
     There are many disadvantages to the above procedure. Typically the above mentioned procedure is performed in an open surgical environment. Current minimally invasive techniques are difficult for surgeons to master, and have many additional drawbacks. Also, there is a high level of patient uneasiness with the idea of such a drastic procedure which is not easily reversible. In addition, all malabsorption techniques carry ongoing risks and side effects to the patient, including malnutrition and dumping syndrome. 
     Consequently, many patients and physicians prefer to undergo a gastric restriction procedure for the treatment of morbid obesity. One of the most common procedures involves the implantation of an adjustable gastric band. Examples of an adjustable gastric band can be found in U.S. Pat. No. 4,592,339 issued to Kuzmak; RE 36176 issued to Kuzmak; U.S. Pat. No. 5,226,429 issued to Kuzmak; U.S. Pat. No. 6,102,922 issued to Jacobson and U.S. Pat. No. 5,601,604 issued to Vincent, all of which are hereby incorporated herein by reference. In accordance with current practice, a gastric band is operatively placed to encircle the stomach. This divides the stomach into two parts with a stoma in-between. An upper portion, or a pouch, which is relatively small, and a lower portion which is relatively large. The small partitioned portion of the stomach effectively becomes the patients new stomach, requiring very little food to make the patient feel fall. 
     However, patients and physicians are seeking even more less invasive products and procedures for treating morbid obesity. 
     SUMMARY OF THE INVENTION 
     A method of implanting a device to maintain a plication within a hollow organ. The method uses an elongated member having an end effector at its distal end. The end effector has an outer cylinder having at least one opening, and an inner cylinder having at least one opening. The inner cylinder is at least partially disposed within the outer cylinder and the cylinders are rotatable with respect to each other. The end effector is detachable from the elongated member such that it can remain within the body cavity. The method involves the step of inserting the end effector within the organ of a patient such that it is in contact with tissue. The method also involves the step of applying vacuum through the elongated member so as to dispose tissue within the inner cylinder. The method also involves the step of creating a plication by rotating the cylinders with respect to each other. The method also involves the step of detaching the end effector from the elongated member. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       While the specification concludes with claims particularly pointing out and distinctly claiming the present invention, it is believed the same will be better understood by reference to the following description, taken in conjunction with the accompanying drawings, in which: 
         FIG. 1  is a perspective view of a first embodiment for the tissue plicating device of the present invention; 
         FIG. 2  is a diagrammatic view of the tissue plication device of  FIG. 1 , shown pushed into a tissue area in a gastric cavity; 
         FIG. 3A  is a more detailed, perspective view of the distal end of the tissue plicating device of  FIG. 1 , showing the tip of the device in an initial, closed position; 
         FIG. 3B  is a more detailed, perspective view of the distal end of the tissue plicating device of  FIG. 1 , showing the tip of the device in a partially open position; 
         FIG. 3C  is a more detailed, perspective view of the distal end of the tissue plicating device of  FIG. 1 , showing the tip of the device in a fully open, operative position; 
         FIG. 4  is a diagrammatic view of the tissue plication device of  FIG. 1 , showing the device creating a fold in an area of tissue; 
         FIG. 5  is a perspective view of a second embodiment for the folding member of the tissue plicating device; 
         FIG. 6  is an additional perspective view of the folding member embodiment of  FIG. 5 , showing the folding member jaws in a fully open position; 
         FIG. 7  is a perspective view of a third embodiment for the folding member of the present invention; 
         FIG. 8  is a perspective view of a fourth embodiment for the folding member; 
         FIG. 9  is a perspective view of a fifth embodiment for the folding member; 
         FIG. 10A  is a perspective view of a sixth embodiment for the folding member showing a retractable jaw of the member in a first, retracted position; 
         FIG. 10B  is an additional perspective of the sixth folding member embodiment, showing the retractable jaw in a forward projected position; 
         FIG. 11  shows an alternative embodiment for the tissue plicating device of the present invention, in which the device further comprises a tissue fastening member; 
         FIG. 12A  is a more detailed, perspective view of the fastener embodiment shown in  FIG. 11 ; 
         FIG. 12B  is a top view of the fastener embodiment shown in  FIG. 11 ; 
         FIG. 12C  is an end view of the fastener embodiment shown in  FIG. 11 ; 
         FIG. 13  is a diagrammatic view of the tissue placation device of  FIG. 11 , showing the device pushed into a tissue wall within a gastric cavity; 
         FIG. 14  is a diagrammatic view of the tissue plication device of  FIG. 11 , showing the device placing a fastener on a tissue fold; 
         FIG. 15  is a diagrammatic view similar to  FIG. 14 , showing the gastric cavity subsequent to folding and placement of a fastening member; 
         FIG. 16A  is a perspective view of an alternative embodiment for a tissue plication fastener; 
         FIG. 16B  is a top view of the alternative fastener shown in  FIG. 16A ; 
         FIG. 16C  is a side view of the alternative fastener shown in  FIG. 16A ; 
         FIG. 16D  is an end view of the alternative fastener shown in  FIG. 16A ; 
         FIG. 17  is a perspective view of a third embodiment for a tissue fastener in accordance with the present invention; 
         FIG. 18A  is a perspective view of a fourth embodiment for a tissue fastening device; 
         FIG. 18B  is a side view of the tissue fastening device shown in  FIG. 18A ; 
         FIG. 18C  is an end view of the tissue fastening device shown in  FIG. 18A ; 
         FIG. 19A  is a perspective view of a fifth embodiment for a tissue fastening device; 
         FIG. 19B  is a top view of the tissue fastening device shown in  FIG. 19A ; 
         FIG. 19C  is a side view of the tissue fastening device shown in  FIG. 19A ; 
         FIG. 20A  is a perspective view of a sixth embodiment for a tissue fastening device; 
         FIG. 20B  is a top view of the tissue fastening device shown in  FIG. 20A ; 
         FIG. 20C  is a side view of the tissue fastening device shown in  FIG. 20A ; and 
         FIG. 21  is a perspective view of a seventh embodiment for a tissue fastening device of the present invention; 
         FIG. 22  is a perspective view of an additional embodiment for the tissue plicating implant device of the present invention; 
         FIG. 23  is a view similar to that shown in  FIG. 22  but showing the device in its partially deployed position; 
         FIG. 24  is an exploded view of the embodiment shown in  FIG. 22 ; 
         FIG. 25A-25D  are simplified perspective views of the device shown in  FIG. 1  actually acquiring tissue and forming a plication. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     The present invention pertains to an endoscopic tissue plicating and fastening device for forming tissue folds within a gastric cavity in order to reduce the volume of the cavity. By creating and securing a plurality of folds along the interior walls of the gastric cavity, the present invention reduces the surface area within the cavity, thereby reducing the available food volume in the stomach. The present invention provides a simplified tissue plicating procedure in which the tissue folds are retained by either staples, or absorbable or removable clips, thus enabling the procedure to be easily reversed. Additionally, the present invention enables large areas of the stomach cavity to be plicated transorally, thus providing an effective bariatric treatment without the trauma encountered in an open surgery plication procedure. 
       FIG. 1  illustrates a first embodiment for a tissue plicating device  20  of the present invention. Tissue plicating device  20  comprises a folding member or end effector  22  connected at the distal end of an elongated member such as a flexible endoscope  24 . Folding member  22  includes an open distal end  26  for receiving tissue drawn into the device. A connecting member  30  extends between folding member  22  and endoscope  24  to securely attach the folding member to the endoscope, so that the folding member is transferred along with the endoscope during transoral insertion and removal. Endoscope  24  includes a side port  32  providing access to a working channel within the endoscope, as well as visualization capabilities for guiding device  20  to a desired location within a gastric cavity. Vacuum is provided to folding member  22  for drawing tissue into the device. In the embodiment shown in  FIG. 1 , vacuum is provided through a separate vacuum line  34 , which extends along the exterior length of endoscope  24 . Vacuum line  34  connects at a proximal end  36  to a conventional vacuum source (not shown). In an alternative embodiment, vacuum can be provided to folding member  22  through the working channel of endoscope  24 , rather than through a separate exterior vacuum line. 
     Control of device  20  is provided through a connection  40  that extends along the exterior length of endoscope  24 . Control connection  40  is attached at a distal end to folding member  22  for moving the member between an open and closed position, as will be described in more detail below. At a proximal end, control connection  40  attaches to a control assembly (not shown). The control assembly is operated by a surgeon in order to perform tissue folding and securing procedures. A number of different types of control assemblies may be utilized to drive the folding member of the present invention. These assemblies may include a push/pull cabling system, a rotational cable/rod, a hydraulic actuation system, or an electromagnetic actuation system. 
     To form a tissue plication, device  20  is inserted transorally through an esophageal overtube  42  and into a gastric cavity  44 , as shown in  FIG. 2 . Folding member  22  is inserted through the esophagus and into the gastric cavity in an initial, closed position. This closed position allows for easier transfer into the gastric cavity. Following insertion, endoscope  24  is used to visualize the interior of cavity  44  (with a visualization device common to most endoscopes) and select the appropriate location for placement of a fold. After the location is determined, the distal tip of folding member  22  is pushed into the tissue wall  46  at the selected location, as shown in  FIG. 2 . Vacuum is then applied through vacuum line  34  to draw adjacent tissue into device  20 . As vacuum is applied, the control assembly rotates folding member  22  into an open, tissue receiving position. 
       FIGS. 3A-3C  illustrate the distal end of folding member  22  in greater detail as the member is rotated from a closed to an open position. As shown in the FIGS., folding member  22  comprises a pair of concentric cylinders  50  (inner cylinder),  52  (outer cylinder) each having an open distal end  26 . Lateral slots or apertures  54  extend from open end  26  into opposing sides of each of the cylinders  50 ,  52 . One edge of each of the slots  54  is angled slightly inwardly, as indicated at  56 , in order to guide tissue into the slots. In an initial position, shown in  FIG. 3A , cylinders  50 ,  52  are positioned with the lateral slots  54  of the cylinders offset, thereby substantially closing the sides of the member. To form a tissue fold, one of the cylinders  50 ,  52  is rotated relative to the other cylinder to open lateral slots  54 , as shown in  FIG. 3B . As the cylinder is rotated to gradually open folding member  22 , vacuum is applied to the tissue wall through distal opening  26  to pull the tissue into slots  54 . After folding member  22  is fully opened, as shown in  FIG. 3C , tissue fills slots  54  as the upper and lower layers of the tissue are folded together in a serosa to serosa configuration. 
       FIG. 4  illustrates device  20  with tissue wall  46  folded into a fully open folding member  22  to form a plication  58 . After plication  58  is formed, a tissue fastening mechanism such as, for example, a stapler (not shown), is passed through the working channel of endoscope  24  to secure the plication. Alternatively, the end effector could be detached from the endoscope after the plication is made to secure the tissue together. This could be accomplished by any number of means known to those skilled in the art, such as placing matching detents on the cylinders which latch when the end effector is in its closed position. 
     After plication  58  is secured, the fastening mechanism is withdrawn, and the vacuum through line  34  turned off, to release the plication from folding member  22 . Following release of the plication, cylinders  50 ,  52  are rotated to close folding member  22 . Endoscope  24  and folding member  22  may then be moved to another location within the gastric cavity to form an additional plication. Once in the new location, vacuum is, again applied to folding member  22  as the member is rotated open, to draw tissue into a fold within lateral slots  54 . After folding, the tissue is again secured, the vacuum turned off, and folding member  22  rotated to a closed position. This procedure for forming a tissue plication may be repeated at multiple locations within the gastric cavity until the desired number of plications have been completed. In a typical bariatric procedure, it is anticipated that 5 or 6 plications would be formed within the gastric cavity to produce approximately a 50% volume reduction. A lesser or greater number of plications may be formed, however, depending upon the particular needs of the patient. 
       FIGS. 5 and 6  illustrate an alternative embodiment for the folding member of the present invention. In this alternative embodiment, the tissue folding member comprises a pair of semi-circular reciprocating jaws  60  connected at the distal end of endoscope  24  by connecting member  30 . Jaws  60  are attached together by pivot pins  62  to open and close relative to a distal opening  64 . Each of jaws  60  is operated through control connection  40  to pivot outwardly relative to the axial centerline of the folding member. Vacuum is applied to the interior area between jaws  60  by vacuum line  34 . Jaws  60  are initially in a closed position during transoral insertion into the gastric cavity. Once in the cavity, the distal edges of jaws  60  are pushed into the tissue wall at the desired plication location, in a manner similar to that described above with respect to the first folding member embodiment. Once jaws  60  are lodged in the tissue wall, the vacuum source is turned on, and the jaws are slowly opened to fold the tissue wall into the opening between the jaws. A pair of teeth  66  may be located adjacent the outer edge of each jaw  60  for grasping and holding the folding tissue in the jaws until the plication is secured and released. After jaws  60  are fully opened, as shown in  FIG. 6 , a tissue securing device may be passed through the working channel of endoscope  24  to secure the fold. 
     In an alternative embodiment to that shown in  FIGS. 5 and 6 , the tissue folding member may comprise a set of tissue grasping jaws in which one jaw rotates relative to a fixed second jaw. In this embodiment, shown in  FIG. 7 , the folding member comprises a cylinder  70  with the upper portion cutaway to form a fixed lower jaw  72 . Lower jaw  72  extends axially from cylinder  70  as a semi-circular distal projection. A mating, semi-circular upper jaw  74  is attached to the folding member by pivot pins  76 . Upper jaw  74  extends in a parallel fashion to lower jaw extension  72 . To form a tissue fold, vacuum is applied through the interior of cylinder  70  to draw the tissue wall proximally into an opening  78  between jaws  72 ,  74 . As tissue is pulled between the jaws, upper jaw  74  is pivoted away from lower jaw  72 , via control connection  40 , to increase the size of the tissue opening and allow the tissue wall to fold into the opening. After upper jaw  74  is pivoted to a fully open position, the folded tissue between the jaws is secured by a fastening device passed through endoscope  24 . Vacuum is then turned off, and the secured plication released from the folding member. 
       FIG. 8  illustrates another alternative embodiment for the folding member of the present invention. In this embodiment, tissue folding is accomplished through a cylindrical end piece  80  attached by connecting member  30  at the distal tip of endoscope  24 . End piece  80  includes a side slot  82  that extends proximally from an open distal end  84 . Vacuum is applied through the interior of end piece  80  to draw tissue into open end  84  and up into slot  82 . As the tissue is pulled into slot  82 , the walls of the tissue are folded together. After the tissue has been fully drawn up into slot  82 , a securing device may be passed through endoscope  24  to affix the tissue layers together. Following tissue securement, the vacuum through line  34  is turned off to release the tissue plication from distal end  84 . 
       FIG. 9  shows yet another embodiment for a tissue folding member of the present invention, in which the member comprises a cylinder  90  having an open distal end  92  and a pair of side slot openings  94 ,  96 . In this embodiment, vacuum is applied through cylinder  90  and open distal end  92  to draw tissue into the device. As tissue is pulled into the device, the tissue expands up into side slots  94 ,  96 . As tissue is drawn into side slots  94 ,  96  a fold is formed therein. After the tissue as been fully drawn up into slots  94 ,  96 , a securing device may be passed through endoscope  24  to affix the tissue layers together. Following tissue securement, the vacuum through line  34  is turned off, and the device retracted away from the cavity wall in order to release the tissue plication from distal end  92 . The folding member embodiments shown in  FIGS. 8 and 9  both comprise a fixed cylindrical body for drawing tissue into the device. Accordingly, these embodiments eliminate the need to extend a control connection  40  to the distal end of the device in order to operate the folding member. 
       FIGS. 10A and 10B  illustrate an additional embodiment for a tissue folding member of the present invention. In this embodiment, the folding member comprises a cylindrical piece  100  having a first, fixed jaw  102  projecting from an open end  104 . A second, retractable jaw  106  extends into open end  104  on a side opposite fixed jaw  102 . To form a tissue fold in this embodiment, the distal tip  107  of the folding member is pushed into the gastric tissue wall at a desired plication location. Second jaw  106  is initially in a retracted position, shown in  FIG. 10A , when the folding member is positioned against the tissue wall. Once tissue contact is made at the desired location, vacuum from line  34  is applied through the interior of cylinder  100  to pull tissue onto first jaw  102 . After the tissue wall is engaged with first jaw  102 , second jaw  106  is moved distally, substantially parallel to first jaw  102 , to pull the tissue outward and fold the tissue over the first jaw. The tip of second jaw  106  is radii smooth, as indicated by reference numeral  108 , to facilitate the second jaw sliding over the tissue. After second jaw  106  is fully extended, as shown in  FIG. 10B , a fastening mechanism is passed through the interior of cylinder  100  to fasten the plication. After fastening, the vacuum through cylinder  100  is turned off, and jaw  106  retracted back into cylinder  100 . The folding member may then be moved to a new tissue location to form additional plications, or removed from the patient. 
     In alternative embodiments for gastric plicating device  20 , the device further comprises a fastening means for securing the tissue plication subsequent to tissue folding. Use of a fastening means on device  20  eliminates the need to pass a separate tissue fastening mechanism through endoscope  24  after folding in order to secure the plication. In the embodiment shown in  FIG. 11 , a fastening member  110  is disposed adjacent the distal end of the device for transfer from the device to a plication after folding. Fastening member  110  is held sufficiently secure on device  20  to be passed along with endoscope  24  and folding member  22  into the gastric cavity, yet is removable through control connection  40  at the end of a tissue folding procedure to secure a plication. In the embodiment shown in  FIG. 11 , the fastening member is a wire clip  110  which is retained on connecting member  30  just proximal of the tissue folding slots  54  in folding member  22 . Wire clip  110  is contoured to surround the perimeter of connecting member  30  and folding member  22  and be retained thereon during device insertion. 
     As shown in greater detail in  FIGS. 12A-12C , wire clip  110  comprises a continuous length of thin gauge wire. The proximal end of clip  110  is shaped on opposing sides in a spring form, indicated by reference numeral  112 , to assist in generating sufficient force to clamp onto the folded tissue. From spring form  112 , the wire is shaped into a pair of telescoping jaws  114 ,  116 , as shown in  FIG. 12B . Jaws  114 ,  116  extend distally from spring forms  112  in a parallel fashion to slide along the upper and lower surfaces of a tissue fold. The distal tips  118  of jaws  114 ,  116  may flare outwardly from the axial centerline of clip  110  to facilitate lead-in of the clip onto a tissue fold. As shown in  FIG. 12C , clip  110  has a substantially circular cross-section to conform to the shape of connecting member  30  to aid in retaining the clip on the folding member during the transoral insertion of device  20 . After tissue folding, control connection  40  engages clip  110  to release the clip from folding member  22 , and slide the clip onto the tissue fold. 
       FIG. 13  illustrates device  20  with wire clip  110  disposed thereon engaging a gastric tissue wall prior to folding. As shown in  FIG. 13 , clip  110  is carried on connecting member  30  as device  20  is inserted into gastric cavity  44  and pushed into tissue wall  46  at a desired plication location.  FIG. 14  similarly illustrates gastric cavity  44  as vacuum is applied through folding member  22  to draw tissue wall  46  into a fold. As the tissue fold is formed, jaws  114 ,  116  of clip  110  expand and move over folding member  22  to initially engage the tissue fold. After upper and lower layers of tissue wall  46  are folded together within slots  54 , clip  110  is released from folding member  22  so that jaws  114 ,  116  clamp down on plication  58 . Jaws  114 ,  116  clamp onto plication  58  due to the energy stored in spring forms  112 . After clip  110  engages plication  58 , the vacuum to folding member  22  is turned off, and the remainder of device  20  moved away from the plication location, leaving the fastened plication as shown in  FIG. 15 . 
       FIGS. 16A-16D  illustrate an alternative embodiment for a tissue fastener usable with folding member  22  of the invention. In this embodiment, the fastener comprises a continuous wire clip  120  formed into a pair of parallel extending jaws  122 ,  124  that engage a tissue fold. Jaws  122 ,  124  each comprise a pair of evenly spaced wire lengths that are bent at 180° angles at the proximal ends of the clip, as indicated by reference numeral  126 . The distal ends of jaws  122 ,  124  flare outwardly, as indicated at  128 , to enhance lead-in of the clip onto the tissue fold. Clip  120  also comprises one or more wire shapes for preventing slippage of the clip along the tissue fold. As shown in  FIG. 16C , these wire shapes may comprise indentations or “teeth”  130  placed along the length of either of jaws  122  or  124 . As shown in  FIG. 16D , clip  120  has a substantially circular cross-section that follows the contour of connecting member  30  and folding member  22  to retain the clip on device  20  until released onto a tissue fold through control connection  40 . 
       FIG. 17  illustrates a third embodiment for a tissue fastener in accordance with the present invention. As shown in  FIG. 17 , in this embodiment the tissue fastener comprises a tubular-shaped clip  132 . Clip  132  has an inner diameter that is sized to contour the outer perimeter of connecting member  30  to retain the clip thereon until released onto a fold. Clip  132  has an open distal end  134  for engaging a tissue fold. A pair of semi-circular jaws  136 ,  140  extends along the axial length of clip  132  for engaging a tissue fold as the clip is transferred onto the fold through control connection  40 . Jaws  136 ,  140  each have a rounded distal end for facilitating transfer of clip  132  onto the tissue fold. A plurality of teeth, indicated by reference numeral  142 , extend from the inwardly facing edges of jaws  136 ,  140  to grasp and hold tissue within the clip, thereby preventing the clip from dislodging from the tissue fold after fastening. Clip  132  can be manufactured from either a plastic or a metallic material. Clip  132  can also be made from absorbable material where it will dissolve away after three weeks and pass through the digestive tract safely. It could be made of laminate construction as small particles of absorbable material would pass and no large parts can come off all at once. 
       FIGS. 18A-18C  illustrate another alternative embodiment for a tissue fastening member of the present invention. In this embodiment, a fastener  150  comprises a proximal frame area  152  having a cylindrical contour for fitting about the perimeter of connecting member  30 . The distal end of fastener  150  comprises a pair of semicircular, tissue engaging jaws  154 ,  156 . Jaws  154 ,  156  each have a tapered distal edge, as indicated at  158 , to provide a lead-in for engaging a tissue fold. A pair of holes  160  are located in a midsection of fastener  150 , between proximal frame area  152  and jaws  154 ,  156 . Holes  160  extend perpendicular to the axial length of the fastener. A suture  162  passes through holes  160  and then proximally through openings  164  in frame area  152 . After jaws  154 ,  156  engage a tissue fold, suture  162  is tightened through holes  160  and openings  164  to pull jaws  154 ,  156  inwardly towards the tissue fold. As jaws  154 ,  156  are pulled inwardly, the jaws deflect laterally along the upper and lower surfaces of the fold, clamping the fold between the jaws. A suture lock  166  is placed on suture  162  after tissue fastening, to prevent the suture from relaxing and releasing the tissue fold from jaws  154 ,  156 . 
       FIGS. 19A-19C  illustrate yet another alternative embodiment for the fastening means of the present invention. In  FIGS. 19A-19C , a fastener  170  is shown having a proximal frame area  172  and a distal clamping area  174 . Proximal frame area  172  has a cylindrical cross-section for retaining fastener  170  about the perimeter of connecting member  30 . Clamping area  174  comprises a pair of semicircular, tissue engaging jaws  176 ,  180 . Jaws  176 ,  180  each have a tapered distal edge, as indicated at  182 , for ease in engaging a tissue fold. Additionally, rows of tissue grasping teeth  184  extend along the inward facing edges of jaws  176 ,  180  to prevent the fastener from slipping along the tissue fold. A pair of holes  186  is located in a midsection of fastener  170 , between frame area  172  and clamping area  174 . Holes  186  extend perpendicular to the axial length of the fastener. In a manner similar to the embodiment shown in  FIGS. 18A-18C , a suture  190  passes through holes  186  and openings  188  to clamp jaws  176 ,  180  inwardly onto a tissue fold. A plurality of notches, indicated by reference numeral  192 , extend axially along the distal end of jaws  176 ,  180 . Notches  192  allow jaws  176 ,  180  to flatten out along the surface of the tissue fold when tightened by suture  190 . Notches  192  also facilitate the application of an even clamping force to the fold. A suture lock  194  is placed on suture  190  to prevent the suture from relaxing and releasing the tissue fold from jaws  176 ,  180 . An additional plurality of openings  196  extend through clamping area  174  to enable fastener  170  to be stitched closed from the inside of the cavity, in order to further secure the tissue fold. 
       FIGS. 20A-20C  illustrate another alternative embodiment for the tissue fastening means of the present invention. In this embodiment, a fastener  200  comprises a ring  202  and a pair of telescoping jaws  204 ,  206  extending distally from the ring. The distal edges of jaws  204 ,  206  are tapered, as indicated at  208 , to provide a lead-in edge for fastener  200  to roll over a tissue fold. The first jaw  204  comprises a cutout  210  that mirrors the outer profile of the second jaw  206  to enable the jaws to interdigitate when the jaws are clamped together on a tissue fold. Jaws  204 ,  206  are preloaded towards an axial centerline  212  of the fastener to compress and hold the folded tissue as the fastener is drawn over the fold. 
       FIG. 21  illustrates yet another clip  220  for fastening a tissue fold. Clip  220  comprises a proximal spring end  222 . A pair of jaws  224 ,  226  project forward from spring end  222  to a rounded distal end  230 . Distal end  230  is rounded to facilitate placement of clip  220  on a tissue fold. Spring end  222  serves to clamp jaws  224 ,  226  on a tissue fold and inhibit the clip from slipping along the fold. To further prevent clip  220  from releasing from a tissue fold, a plurality of serrated teeth  232  extend substantially along the length of jaws  224 ,  226 . Teeth  232  may be angled proximally to prevent clip  220  from being removed from the tissue fold. Alternatively, teeth  232  may be angled distally to enable clip  220  to be removed from a fold provided tissue has not grown over the clip. In the clip depicted in  FIG. 21 , teeth  232  are placed at a 45 degree angle to hold tissue securely, yet enable subsequent removal of the clip should such removal be required. 
     Yet another embodiment of the present invention is described in  FIGS. 22-24  which shows tissue plicating device  320 . Device  320  is similar to device  20  described above, however the end effector  323  of device  320  is detachable from the distal end  232  of endoscope  324 . After the tissue is acquired and pinched within end effector  323  (such as described in  FIG. 25  below), a push rod within the endoscope (not shown) pushes on collar  350 , moving the end effector  323  distally so as to expose legs  360 . Legs  360  are biased outwardly such that as they move distally the remove their grip on the end effector  323 , thereby releasing end effector  323  from attachment with the scope  324 . 
     How device  20  operates within the body can be described by looking at  FIGS. 25A through 25B . As shown in  FIGS. 25A and 25B  the end effector  22  has been placed within the body in its closed position and is placed adjacent to tissue  400 . Vacuum is the applied to draw the tissue within the closed cylinder of end effector  22 . Thereafter, the cylinders are rotated as shown in  FIGS. 25C and 25D . Now, a clip or other fastening means such as those described above can be applied to maintain the plication. For the embodiment shown in  FIG. 22 , the device can now be rotated even further to pinch the tissue between the cylinders to maintain the plication. In addition the Figures show the cylinders having gripping means  17  on either or both cylinders to better grip tissue therein. 
     The present invention has been described above with respect to its use during a transoral plication procedure. However, it should be understood that the device is also adaptable for use during laparoscopic and open tissue plication procedures without departing from the scope of the invention. Additionally, it is intended that each of the embodiments described above for the folding member be interchangeable and useable with each of the tissue fastening embodiments during a tissue plication procedure. 
     It is also to be understood that the above described might be sterilized and reused. There are any number of sterilization methods known to those skilled in the art including: gamma radiation and ETO. 
     While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the spirit and scope of the appended claims.