Abstract:
An endoscopically implantable device is provided that cinches the stomach together to create a reduced diameter for a portion of the stomach. The device may be, for example, a gastrorestrictive device used to treat overweight or obese patients. The device may be used, for example, to treat gastroesophogeal reflux disease (GERD).

Description:
RELATED APPLICATION DATA  
       [0001]     This application is a continuation in part of U.S. application Ser. No. 10/295,115, filed Nov. 14, 2002, which is a divisional of U.S. application Ser. No. 09/847,884 filed May 1, 2001 all of which are incorporated herein by reference. 
     
    
     FIELD OF THE INVENTION  
       [0002]     The invention relates to a gastric constriction device for restricting the diameter of a portion of a stomach or creating a small pouch in the stomach.  
       BACKGROUND  
       [0003]     A variety of devices and techniques have been used to surgically alter the digestive tract of a patient in order to treat obesity and related diseased. The techniques include creating a small pouch in a patient&#39;s stomach that restricts emptying(restrictive procedures), bypassing a portion of the digestive tract, e.g. or the stomach or small intestines (malabsorptive procedures), or a combination of both.  
         [0004]     Most of these techniques involve substantial surgery where portions of the stomach are stapled closed and/or where the gastrointestinal tract is shortened by rerouting portions of the gastrointestinal tract to reduce absorption of nutrients. These surgical procedures are expensive and create substantial risks to the patient either during surgery, in recovery or with respect to subsequent failure of the procedure.  
         [0005]     The Lap Band® procedure, a less invasive procedure, has been used where a band is laparoscopically delivered to the outside of the stomach. In the Lap Band® procedure, the band is positioned around an upper portion of the stomach and tightened to create a small stomach pouch. The band may be inflatable so that the diameter of passageway exiting the small pouch is adjustable.  
         [0006]     However, the Lap Band® procedure still requires tunneling through the abdomen to the stomach in a laparoscopic procedure. Also, the laparoscopic banding devices and procedures have had complications that result in stomach perforation.  
         [0007]     Accordingly, it would be desirable to provide an improved gastric restrictive device and procedure.  
         [0008]     In treating gastroesophogeal reflux disease, a procedure known as a fundal plication is performed which brings the stomach wall together just below the lower esophageal sphincter (LES). This is typically performed in an open or laparoscopic procedure.  
         [0009]     Accordingly, it would be desirable to provide a less invasive or alternative procedure for treating GERD.  
       SUMMARY OF THE INVENTION  
       [0010]     The present invention provides a device that cinches the stomach together to create a reduced diameter for a portion of the stomach. The present invention also provides such a device that may be implanted endoscopically, i.e., through the esophagus into the stomach. The present invention also provides a gastrorestrictive device that may be used to treat overweight or obese patients. The present invention also provides a device that may be used to treat gastroesophogeal reflux disease (GERD) by using a device to endoscopically perform a procedure with a similar result as a fundal plication, i.e., a reduced stomach diameter near the LES.  
         [0011]     According to one aspect of the invention anchors are endoscopically deployed in the stomach. Cinching mechanisms such as, e.g., a wire or tether, are attached to the anchors. The cinching mechanisms and are used to draw portions of the stomach together to create a reduced diameter for at least a portion of the stomach. The cinching mechanisms may be tied together with a connector. The taughtness of the cinching mechanisms or the size of the reduced stomach diameter may be adjustable. 
     
    
     DESCRIPTION OF THE DRAWINGS  
       [0012]      FIG. 1  illustrates a device implanted in the stomach in accordance with the invention.  
         [0013]      FIG. 2  illustrates the device implanted in the stomach of  FIG. 1  with the stomach cinched to form a reduced diameter.  
         [0014]      FIG. 3  is an enlarged view of a portion of the device of  FIG. 1 .  
         [0015]      FIG. 4  is a top view of a device in accordance with the invention.  
         [0016]      FIG. 5A  is a top view of a device in accordance with the invention.  
         [0017]      FIG. 5B  is an enlarged view of the connecting ring of the device of  FIG. 5A .  
         [0018]      FIG. 5C  is an enlarged view of a portion of the connecting ring of  FIG. 5C  with a connecting wire.  
         [0019]      FIG. 6  illustrates the device of  FIGS. 5A-5C  being implanted in the stomach.  
         [0020]      FIG. 7A  is a front view a device in accordance with the invention, implanted to treat gastroesophogeal reflux disease.  
         [0021]      FIG. 7B  is a side view of the device of  FIG. 7A .  
     
    
     DETAILED DESCRIPTION  
       [0022]     Referring to  FIGS. 1-3  a device  110  in accordance with the invention is illustrated. The device  110  comprises a plurality of anchors  120  attached to the wall of a stomach  100 .  
         [0023]     As illustrated in  FIG. 3 , each anchor  120  comprises an end portion  121  configured to interface with the outside of the stomach wall hold the anchor  120  in place. The end portion  121  has a sufficient surface area with respect to forces applied to the anchor to prevent device pull out. An elongate portion  122  extends from the end portion  121  into the stomach  100 . A connecting device  123  is coupled inside the stomach to the elongate portion  122 .  
         [0024]     As illustrated in  FIG. 1 , a tether  124  extends through each connecting devices  123  (e.g., through a hole). The tether  124  is then joined in a loop with one end of the tether extending through a loop  125  in the other end of the tether and extending out of the stomach.  
         [0025]     As illustrated in  FIG. 2 , the tether  124  used to draw the stomach wall together. This creates a small pouch for receiving food and a small diameter conduit for passing food from the pouch. Thus a feeling of satiety of fullness is sensed after ingestion of a smaller amount of food. The tether  124  is secured in the cinched position e.g. with a securing device in the loop  125  or by crimping the tether  124  ends together at the loop  125  and trimming the excess length of the tether extending out of the stomach.  
         [0026]     The anchors  120  may be implanted endoscopically through the esophagus. For example, the end portion  121  may be delivered by way of a cannula or hollow needle from the inside of the stomach and through the stomach wall. Examples of attaching device to the inside of the stomach wall are described in related co-pending U.S. application Ser. No. 10/295,115, filed Nov. 14, 2002, which is a divisional of U.S. application Ser. No. 09/847,884 filed May 1, 2001, incorporated herein by reference.  
         [0027]      FIG. 4  illustrates a variation of the device  200  in accordance with the invention. Anchors  220   a - f  comprise end portions  221   a - f  interfacing with the outside of the stomach wall, and tethers  224   a - f  extending from the end portions  221   a - f  respectively through the stomach wall  101  and into the stomach  100 . Anchors  220   a ,  220   b , anchors  220   c ,  220   d , and anchors  220   e ,  220   f  are respectively positioned across from each other to form pairs that draw the stomach together in a folded configuration. Accordingly, tethers  224   a ,  224   b  are connected with connector  225 ; tethers  224   c ,  224   d  are connected with connector  226 ; and tethers  224   e ,  224   f  are connected with connector  227 . The tethers  224   a - f  may be drawn together as illustrated and the excess length trimmed.  
         [0028]     The anchors  220   a - f  may be implanted endoscopically in a manner similar to anchors  120  described herein.  
         [0029]      FIGS. 5A-6  illustrate another variation of a device  300  in accordance with the invention. Anchors  320  are arranged circumferentially about the stomach  100 . Anchors  320  include end portions  321  interfacing with the outside of the stomach wall, and tethers  324  extending from the end portions  321  through the stomach wall  101  and into the stomach  100 . Tethers  324  are connected to the connecting ring as shown in  FIG. 5C .  
         [0030]     Connecting ring  325  comprises a plurality of openings  326  extending around the circumference of the ring  325 . The tether  324  includes a plurality of ball members  323  staggered along the length of the tether  324 . Each of the tethers  324  are positioned through the openings  326  in the ring  325 . The openings  326  each comprise a wider diameter portion  327  through with the ball members  323  are sized to pass, and a narrow portion  328  that are narrower than the ball members  323 . The tethers  324  are pulled through the openings  326  in the ring  325  to cinch the stomach wall. When the desired diameter opening is achieved, the tethers  324  are secured or locked into the ring  325  by positioning the tether  324  through the narrow portion  328  of the opening. The tether  324  may be further secured in position with other mechanical safety features such as, e.g., hooks or stops that move or rotate into a position that prevents the tether from moving from the narrow postion  328  to the wider diameter portion  327 .  
         [0031]      FIG. 6  illustrates the implanting of the device  300  described with respect to  FIGS. 5A-5C . The anchors  320  are implanted endoscopically in a manner similar as anchors  120  described herein. The tethers  324  extend from the stomach  100  and out through the esophagus  102 . Each of the tethers  324  may be numbered or otherwise identified with reference to their position about the stomach  100 . The tethers are inserted through the openings  326  in the ring outside of the patient&#39;s mouth  103 . The ring is sized so that it may fit through endoscope  105  that extends into the stomach  100 . The ring  325  is then pushed through the endoscope  105  into the stomach while holding the ends of the tethers  324  outside of the mouth. Each of the tethers  324  are pulled, drawing the stomach inward until the desired diameter opening is formed in the stomach  100 . Each tether  324  is then secured to the ring  325  and the tethers are trimmed to remove at least a portion of the extra length. The tethers  324  and ring  325  are configured so that the taughtness of the cinched stomach may be adjusted. Leaving a portion of a length of a tether allows the device to be loosened and the diameter of the opening through the stomach formed by the device can be increased. Similarly the device may be tightened so that the diameter of the opening through the stomach is decreased. This may be done using endoscopically placed instruments.  
         [0032]      FIGS. 7A and 7B  illustrate a device  400  in accordance with the invention that is being used to treat gastroesophogeal reflux disease (GERD). One or more pairs of opposing anchors  420  are implanted at a location just below the lower esophageal sphincter  102  and in the stomach  100 . Anchors  420  include tethers  424  that are connected with connector  425  in a manner similar to that described herein with reference to anchors  220   a - f  and tethers  224   a - f  illustrated in  FIG. 4 . This provides relief to the lower esophageal sphincter in a manner similar to that of a fundal plication procedure typically used to treat GERD.  
         [0033]     While this invention has been described with reference to preferred embodiments thereof, it will be apparent to one skilled in the art that various modifications and changes can be made without departing from the scope of the invention.