Abstract:
A method for creating an anastomosis between a stomach and a portion of a small intestine, and simultaneously controlling passage of stomach contents through a pylorus with a pylorus plug that includes a valve operative to either close or at least partially open passageway through the pylorus.

Description:
FIELD OF THE INVENTION 
       [0001]    The present invention generally relates to methods for creating an anastomosis in the gastrointestinal (GI) tract, while obstructing or reducing flow of gastric contents across the pyloric valve (pylorus). 
       BACKGROUND OF THE INVENTION 
       [0002]    Magnetic anastomosis devices are used to create a channel between two viscera for the purpose of redirecting bodily fluids. For example, intestinal contents or bile may be redirected in patients who have developed an obstruction of the bowel or bile duct due to such conditions as tumor, ulcer, inflammatory strictures or trauma. Some magnetic anastomosis devices include first and second magnet assemblies comprising magnetic cores that are surrounded by thin metal rims. Due to the magnetic attraction between the two magnetic cores, the walls of two adjacent viscera (e.g., the gall bladder, common bile duct, stomach, duodenum, or jejunum) may be sandwiched and compressed between the magnet assemblies, resulting in ischemic necrosis of the walls to produce an anastomosis between the two viscera. 
         [0003]    US Patent Application 20100292729 to Aguirre, the disclosure of which is incorporated herein by reference, describes a magnet delivery system for forming an anastomosis in the GI tract. The system includes a guidewire, a delivery catheter, an expandable balloon and a magnet. The magnet is removably secured to the delivery portion of the catheter between first and second ports. 
       SUMMARY OF THE INVENTION 
       [0004]    The present invention seeks to provide improved methods for creating an anastomosis in the GI tract, while obstructing or reducing flow of gastric contents across the pylorus, as is described more in detail hereinbelow. The method is particularly useful in a transoral gastrointestinal procedure, but can be carried out through other orifices. 
         [0005]    There is thus provided in accordance with an embodiment of the present invention a method for creating an anastomosis between a stomach and a portion of a small intestine, and simultaneously controlling passage of stomach contents through a pylorus with a pylorus plug that comprises a valve operative to either close or at least partially open passageway through the pylorus. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0006]    The present invention will be understood and appreciated more fully from the following detailed description taken in conjunction with the drawings in which: 
           [0007]      FIG. 1  is a simplified cross-sectional illustration of a prior art magnet delivery system for use in forming the anastomosis; 
           [0008]      FIG. 2  is a simplified cross-sectional illustration of a prior art magnet delivery system for delivering two magnets, for use in forming the anastomosis; 
           [0009]      FIG. 3  is a simplified illustration of a magnet delivery system for use in forming an anastomosis, constructed and operative in accordance with an embodiment of the present invention; 
           [0010]      FIG. 4  is a simplified illustration of an expanded balloon of the magnet delivery system of  FIG. 3 , wherein the expanded balloon is used to compact walls of the jejunum to make way for a magnet; 
           [0011]      FIG. 5  is a simplified illustration of placing another magnet in the stomach, before, during or after placement of a pylorus plug in the pylorus, in accordance with an embodiment of the present invention; 
           [0012]      FIGS. 6 and 7  are simplified and enlarged illustrations, respectively, of magnets compressing together walls of the jejunum and the stomach to create an anastomosis; and 
           [0013]      FIG. 8  is a simplified illustration of a pylorus plug, in accordance with an embodiment of the present invention. 
       
    
    
     DETAILED DESCRIPTION OF EMBODIMENTS 
       [0014]    In accordance with one embodiment of the present invention, the method includes delivery of magnets to form the anastomosis. Merely for the sake of simplicity, an exemplary embodiment is described with reference to the magnet delivery system of US Patent Application 20100292729, but the invention is not limited to this magnet delivery system. 
         [0015]    Reference is now made to  FIG. 1 . The magnet delivery system includes a catheter  10 , a guidewire  12 , and an expandable balloon  14  to deliver a magnet  16 . The expandable balloon  14  is on the distal end of catheter  10  and is distal to magnet  16 . Balloon  14  precedes magnet  16  during implantation so that it may dilate any strictures along the way. Once dilation has occurred, magnet  16  can be advanced to the jejunum or other desired location in the GI tract. Guidewire  12  passes through a lumen of magnet  16 , first  18  and second  20  ports, and a first lumen  22  of catheter  10 . Catheter  10  has a second lumen  24  that is in fluid communication with the interior of expandable balloon  14 . Expandable balloon  14  can be, without limitation, non-compliant with a predetermined shape and fabricated from materials, such as but not limited to, polyethylene, polyethylene terephthalate (PET), or polyamides. 
         [0016]    Magnet  16  is shown having a general disc shape, but other shapes, such as but not limited to, circular, cubular, cylindrical, polygonal, oval or ovoid, square and others, can also be used. Magnet  16  may include a protective coating (such as, but not limited to, polytetrafluoroethylene) for protection of the magnetic core from corrosive digestive acids or other bodily fluids. 
         [0017]    Magnet  16  may be formed with an annular rim  26 , which is slightly raised above the center of magnet  16  so as to form a basin  28  to accommodate or mate with a second magnet (as described below). In particular, when magnet  16  is delivered, rim  26  contacts the wall of the viscera and helps to initiate the ischemic necrosis of the tissue captured between magnet  16  and a mated second magnet. One or more radiopaque markers  30  may be placed on magnet  16  and/or on catheter  10  in the vicinity of magnet  16  (or other places) to mark the magnet location when viewed through fluoroscopy. 
         [0018]      FIG. 2  illustrates two delivery systems of  FIG. 1 , except that in the second delivery system a second magnet  32  is affixed to another catheter  10 . The second magnet  32  has an annular recess  36  that is capable of mating with the annular rim  26  of the first magnet  16 . 
         [0019]      FIG. 3  illustrates a magnet delivery system  50  for use in forming an anastomosis, in accordance with an embodiment of the present invention. The exemplary embodiment is described for creating an anastomosis between the stomach and a portion of the small intestine (such as the duodenum, jejunum or ileum; the example follows for the jejunum). For simplicity, system  50  is shown for the delivery of two magnets  16  and  32  using two catheters  10  ( FIG. 5 ), but system  50  may be used for delivering more than two magnets and at different locations. Alternatively, delivery system  50  can be used to deliver the two magnets using only one catheter. 
         [0020]    The method for delivering the magnets to form the anastomosis includes introducing the delivery system  50  through the esophagus E, stomach S, pylorus P, duodenum D and jejunum J. In  FIG. 3 , delivery device  50  is shown being advanced toward a stricture  55  in the jejunum. Balloon  14  is expanded to dilate stricture  55  so that the catheter  10  can be advanced to the selected treatment site. 
         [0021]    In  FIG. 4 , the expanded balloon  14  compacts the walls of the jejunum to make way for second magnets  32 . The delivery of second magnet  32  follows once guidewire  12  has been positioned adjacent the wall of the jejunum, as seen in  FIG. 5 . Second magnet  32  is placed on dilation catheter  10  ( FIG. 2 ) and held in place on catheter  10  by guidewire  12 . Guidewire  12  is loaded through catheter  10 , passing through second port  20  ( FIG. 2 ) in the catheter lumen, through the lumen of second magnet  32 , and then reentering the catheter lumen through first port  18 . Using the radiopaque markers  30  as a guide, catheter  10  is advanced such that second magnet  32  is placed adjacent to the wall of the jejunum as shown in  FIG. 5 . 
         [0022]    In accordance with an embodiment of the invention, a pylorus plug  60  is introduced and positioned in the pylorus. As is well known in the art, the pylorus defines the passageway between the stomach and the duodenum and includes a pyloric sphincter for controlling the passage of stomach contents into the intestines. As used herein, “pylorus” generally refers to the area of the opening from the stomach to the duodenum, and includes locations both upstream (proximal) of the pyloric sphincter and downstream (distal) of the pyloric sphincter. 
         [0023]    Pylorus plug  60  may be advanced over the same guidewire  12  of catheter  10  as second magnet  32 . Alternatively, pylorus plug  60  may be advanced over another guidewire (not shown). Accordingly, pylorus plug  60  may be positioned in the pylorus before, during or after placement of second magnet  32  in the jejunum. 
         [0024]    Pylorus plug  60  is also shown in  FIG. 8 . In one embodiment, pylorus plug  60  includes a stent body  62 , which may be without limitation, a self-expanding stent or a balloon-expandable stent. The stent body  62  is adapted to expand against the walls of the pylorus to anchor pylorus plug  60  in place. Stent body  62  may optionally have barbs or other protrusions  64  (or other devices, such as hooks, rings, roughened surfaces, etc.) for enhancing fixation. Pylorus plug  60  includes a lumen  66  which is opened or closed with a valve  68 . Valve  68  may be remotely controlled by an external device (such as being electronically or magnetically controlled), or may be controlled manually by a suitable push-pull wire and the like. Pylorus plug  60  may also be provided with one or more radiopaque markers. 
         [0025]    Reference is now made to  FIG. 5 . Before, during or after placement of pylorus plug  60  in the pylorus, the first magnet  16  is introduced into the stomach over guidewire  12 , in a similar manner to introducing second magnet  32  first into the stomach. First magnet  16  is positioned adjacent the wall of the stomach that borders the jejunum near the location of second magnet  32 . To release the first and second magnets  16  and  32 , the operator removes guidewire  12  and then catheter  10 . Magnets  16  and  32  are released so that the magnetic forces attract the magnets together, compressing together the walls of the jejunum and the stomach as seen in  FIGS. 6 and 7 . When implanted and mated with first magnet  16 , second magnet  32  fits within rim  26  of first magnet  16 . 
         [0026]    Once the necrosis of the walls of the stomach and the jejunum is complete, an anastomosis is formed. The magnets  16  and  32  can then pass through the body naturally or can be removed by means such as laparoscopic removal, endoscopic removal, or other procedure. 
         [0027]    The pylorus plug  60  can be left closed, i.e., valve  68  is completely closed so as to block passage of stomach contents therethrough. With pylorus plug  60  completely closed, the only route for stomach contents to flow to the jejunum is through the anastomosis. Alternatively, pylorus plug  60  can be partially or completely opened during or after completion of the anastomosis. In such a case, the stomach contents have two paths to flow through to arrive at the jejunum; valve  68  controls the amount that flows through the pylorus. 
         [0028]    It will be appreciated by persons skilled in the art that the present invention is not limited by what has been particularly shown and described hereinabove. Rather the scope of the present invention includes both combinations and subcombinations of the features described hereinabove as well as modifications and variations thereof which would occur to a person of skill in the art upon reading the foregoing description and which are not in the prior art.