Abstract:
A device for reducing the volume of a hollow body organ includes a tissue port and a plurality of fasteners. The fasteners may be coupled to a flexible filament, such as a suture, which is tensioned to constrict the hollow body organ to achieve volume reduction.

Description:
[0001]    This application claims priority to Provisional Application No. 60/879,402, filed Jan. 8, 2007. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    The present invention is directed to methods and devices for applying fasteners to the stomach or esophagus. The present invention is also directed to methods and devices for restricting the esophagus and/or stomach. 
       SUMMARY 
       [0003]    The delivery device carries fasteners connected to suture. A suture holder such as a sliding knot or adjustable clamp or a crimp sleeve can adjust the length of the connected suture smaller or larger. In the preferred embodiment the suture holder is pre-attached to the suture. For example the suture holder can connect the ends of the suture to form a loop. The delivery device is introduced through the mouth and esophagus into the stomach. The delivery device fastens the tissue with the fasteners. 
         [0004]    An adjusting device pulls the suture, which in turn pull the fasteners and the fastened stomach tissue. This reduces the internal size of the stomach and creates a restrictive gastric pouch. 
         [0005]    The delivery device has a tissue chamber and one or more tissue ports. The tissue chamber can be radially collapsed for introduction into and removal from the patient. After entering the stomach, the tissue chamber can be radially expanded. This reduces folding of the stomach during tissue retraction and enables more accurate placement of fasteners. Tissue is retracted through the tissue port into the tissue chamber and then fastened. For example the tissue can be retracted by suction or mechanical grasping. 
         [0006]    The suture and fasteners can be pre-loaded on and in the delivery device such that after fastening the fasteners and suture are completely releasable from the delivery device without the need to separate the parts of the device. 
         [0007]    The suture can wrap around the outside of the tissue chamber as it passes from one tissue port to the next. The suture can be partially or completely covered for easier introduction of the device into the patient. For example the suture loop can be placed in a recessed groove. The suture can be at least partially covered by a membrane with a releasable adhesive bond to the device, a tearable membrane, a flap with a free edge, or by a removable sheath. 
         [0008]    The fasteners and suture can be delivered in a position and sequence such that the suture forms one of several desired shapes such as an approximately circular loop or a zigzag or a figure eight or overlapping diametral segments. These shapes affect the shape of the tissue. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0009]      FIG. 1  shows a stomach. 
           [0010]      FIG. 2  shows a fastener delivery device having a tissue chamber and tissue ports. 
           [0011]      FIG. 3  shows a radially expandable tissue chamber. 
           [0012]      FIG. 4  shows a cross section of the delivery device with fasteners connected by a suture loop. 
           [0013]      FIG. 5  shows a cutaway portion of the device viewed from inside the tissue chamber. 
           [0014]      FIG. 6  shows the fastener delivery device in the stomach. The tissue chamber is radially expanded. Tissue is retracted into the tissue chamber through the tissue ports. 
           [0015]      FIG. 7  shows a cross sectional view of the fastener delivery device in the stomach. 
           [0016]      FIG. 8  shows fasteners deployed in a sequence to place a suture loop in an approximately circumferential orientation. 
           [0017]      FIG. 9  shows the adjusting device sliding the suture holder to reduce the length of the suture loop. 
           [0018]      FIG. 10  shows the suture tightened to reduce the luminal area of the stomach. 
           [0019]      FIG. 11  shows two fasteners deployed from two tissue ports approximately 180 degrees apart. 
           [0020]      FIG. 12  shows rotating the device approximately 90 degrees and deploying two more fasteners approximately midway between the first two fasteners. 
           [0021]      FIG. 13  shows the suture tightened to reduce the luminal area of the stomach. 
           [0022]      FIG. 14  shows the suture before loading into the device in which the suture loop crosses itself to form a “figure 8” shape. 
           [0023]      FIG. 15  shows the crossed suture and fasteners loaded into the delivery device. 
           [0024]      FIG. 16  shows the “figure 8” loop in the stomach, with the suture oriented partly circumferential and partly diametral. In this example each fastener penetrates a single layer of tissue. 
           [0025]      FIG. 17  shows an intraluminal view of fasteners deployed into tissue. 
           [0026]      FIG. 18  shows fasteners deployed to place the suture in a “backstitched” orientation. 
           [0027]      FIG. 19  shows fasteners deployed at varying axial heights to place the suture in a zigzag orientation. 
       
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0028]    Referring to  FIG. 1 , a gastroesophageal region  40  is shown which includes an esophagus  41  leading to a stomach  43 . The stomach  43  includes a greater curvature  44  and a lesser curvature  45  and a fundus  46 . A cardiac notch  47  is formed at the junction between the esophagus  41  and the stomach  43  which forms an angle of HIS  57 . A gastroesophageal junction  52  lies between a lower esophageal sphincter  48  and a gastroesophageal flap valve  49 . A diaphragm  53  extends around the stomach  43 . 
         [0029]    Referring to  FIGS. 2-4 , a delivery device  400  is shown which has a tissue chamber  402  and one or more tissue ports  410 . Tissue is drawn into the tissue ports  410  and fastened together with fasteners  411 . Tissue is drawn into the tissue ports  410  using suction although a mechanical grasper may also be used. The device  400  may include a valve  404 , such as a duck bill valve, at the distal end which may receive an endoscope as is known in the art. 
         [0030]    Referring to  FIG. 3  and  FIG. 4 , the tissue chamber  402  may be expanded by tensioning a control line  406  which causes the tissue chamber  402  to expand and bow outward. Expansion of the tissue chamber  402  may help to prevent excessive folding of the tissue while permitting a relatively large amount of tissue to create the tissue fold. The device  400  includes struts  408  which support the tissue chamber  402  and help to form a desired shape when the tissue chamber  402  is expanded. 
         [0031]    The device  400  is loaded with a number of fasteners  411  and a flexible filament  413  such as suture  415  or the like. The filament  413  may form a closed loop with a knot  417  or other suitable method of securing one part of the filament  413  to another to maintain tension on the filament  413  as described below. The filament  413  may extend out of one of the tissue ports  410  and re-enter the device through another tissue port  410  as shown in  FIG. 3 . The filament  413  may be covered by a flap  415  which covers the filament  413  while permitting release of the filament  413  through a free edge. 
         [0032]    Referring to  FIG. 5 , the fasteners and filament  413  are shown positioned above the tissue port. The fasteners  411  are mounted to a stylet  418  having a pusher  419  that is positioned in a stylet tube  422 . The stylet  418  has a sharp tip  424  which is used to penetrate tissue. The fastener  411  may have a groove  426  or other feature which permits release of the fastener  411  from the stylet  418 . A number of fasteners  411  may be deployed through each of the tissue ports  410  as explained below. The flap  415  covers the portion of the filament  413  extending from one of the tissue ports to an adjacent tissue port  410 . 
         [0033]    Referring now to  FIG. 6 , the device  400  is shown with the tissue chamber  402  expanded. Tissue is drawn into the tissue ports  410  to form a tissue fold in each of the tissue ports  410 . The fasteners  411  are then driven through the tissue folds using the stylet  418 . The filament  413  may then be tensioned to draw the fasteners  411  together. In this manner, a hollow body structure such as the stomach may be reduced in volume.  FIGS. 7 and 8  show two fasteners  411  deployed from each tissue port  410 . Referring to  FIG. 9 , the filament  413  may be tensioned to draw the tissue structures together as shown in  FIG. 10  to form two lobes in the stomach. Tension on the filament  413  may be applied and maintained using a tightening device  426  which may create a knot or use a sleeve  421  to tighten and maintain tension on the filament  413 . 
         [0034]    Referring now to  FIGS. 11-13 , still another method of using the device  400  is shown. One fastener  411  is delivered through each of the tissue ports  410  as shown in  FIG. 11 . The device  400  is then rotated to the position of  FIG. 12  and two more fasteners  411  are deployed. The filament  413  may then be tensioned to form four lobes in the stomach. Referring to  FIGS. 14-16 , the filament  413  may also be configured to extend across the hollow body structure in a pattern similar to a figure-8.  FIG. 15  shows the filament  413  loaded onto the delivery device  400 . Two of the fasteners  411  are deployed through the tissue ports  410  and the device  400  is rotated and two more fasteners  411  are deployed. The filament  413  is then tensioned to draw the tissue structure together as shown in  FIG. 16 . 
         [0035]      FIGS. 17-19  show various configurations for the filament  413 .  FIG. 17  shows the filament  413  deployed in an approximately planar ring.  FIG. 18  shows the filament  413  in a backstitched orientation.  FIG. 18  shows fasteners can be deployed to place the suture in a “backstitched” orientation. For example, the device can be rotated between sequential fastener deployments. As may be appreciated from the figure, when the suture is tightened further the fasteners will pull tissue sideways. 
         [0036]      FIG. 19  shows the filament  413  in a zigzag orientation at varying axial heights. A zigzag loop can increase the number of tissue folds such that the outlet area from a gastric pouch is reduced more than from a non zigzag loop. As may be appreciated from  FIG. 19 , when the suture is tightened further the zigzag will decrease in axial amplitude and the fasteners will pull tissue axially closer together as well as circumferentially closer together. 
         [0037]    Placing the fasteners in the desired pattern alters the shape of the suture loop. In turn this alters the suture&#39;s direction of pull on the fasteners and the fasteners direction of pull on the tissue. This can be used to cause the tissue to fold in beneficial ways. 
         [0038]    Fastening a single suture such that multiple segments have tension components in the same direction increases the force on the tissue in that direction. For example a diametrically oriented suture can be more efficient at pulling tissue radially inward than a circumferential suture. 
         [0039]    The tensioning element or suture holder may be a sliding knot such as a Roeder knot. The tensioning element or not may also be a clip that is crimped to the suture loop or a sleeve that can slide on the suture loop. The adjusting device can also be a flexible endoluminal crimper that crimps the suture holder to hold the suture. 
         [0040]    The present invention has been described with reference to preferred embodiments; however, numerous changes may be made without departing from the scope of the invention.