Apparatus and method for manipulating stomach tissue and treating gastroesophageal reflux disease

Abstract

Stomach tissue is manipulated to form, for example, a restored flap of a gastroesophageal flap valve. The manipulation includes gripping stomach tissue from within the stomach while the stomach is inflated to promote visualization and stabilization of the gripped stomach tissue. Once the stomach tissue is gripped, the stomach is deflated and pulled into a mold. The molded tissue is then fastened with at least one fastener. The stomach is inflated to a first pressure during visualization and then to a second higher pressure during the stomach tissue gripping.

1 . A method of restoring a flap of a gastroesophageal flap valve associated with a stomach, comprising: 
 inflating the stomach;    gripping stomach tissue from within the stomach at a point displaced from the esophageal opening of the stomach;    deflating the stomach;    pulling the gripped stomach tissue into a mold to form molded tissue; and    deploying at least one fastener through the molded tissue.    
     
     
         2 . The method of  claim 1 , wherein the stomach is associated with an esophagus and wherein the method further comprises gripping a wall of the esophagus prior to gripping the stomach.  
     
     
         3 . The method of  claim 2 , wherein the step of gripping a wall of the esophagus includes gripping the wall of the esophagus with a vacuum.  
     
     
         4 . The method of  claim 1 , further comprising reinflating the stomach before deploying the at least one fastener.  
     
     
         5 . The method of  claim 1 , further comprising releasing the grip on the stomach tissue after the at least one fastener is deployed.  
     
     
         6 . The method of  claim 1 , further comprising repeating the inflating, gripping, deflating, pulling, and deploying steps for deploying at least one other fastener displaced from the at least one fastener.  
     
     
         7 . The method of  claim 6 , further comprising measuring from the molded tissue prior to repeating the gripping step.  
     
     
         8 . The method of  claim 1 , wherein the inflating step includes inflating the stomach to a first pressure, wherein the method further comprises visualizing the stomach from within the stomach after inflating the stomach to the first pressure, and increasing inflation pressure within the stomach to a second pressure after visualizing the stomach before gripping stomach tissue.  
     
     
         9 . The method of  claim 8 , wherein the stomach is associated with an esophagus and wherein the method further comprises gripping a wall of the esophagus after inflating the stomach to the first pressure and prior to gripping the stomach.  
     
     
         10 . A method of restoring a flap of a gastroesophageal flap valve associated with a stomach, comprising: 
 gripping stomach tissue from within the stomach at a point displaced from the esophageal opening of the stomach;    collapsing the stomach;    pulling the gripped stomach tissue into a mold to form folded flap of tissue; and    deploying at least one fastener through the folded flap of tissue.    
     
     
         11 . The method of  claim 10 , wherein the stomach is associated with an esophagus and wherein the method further comprises gripping a wall of the esophagus prior to gripping the stomach.  
     
     
         12 . The method of  claim 11 , wherein the step of gripping a wall of the esophagus includes gripping the wall of the esophagus with a vacuum.  
     
     
         13 . The method of  claim 10 , further comprising repeating the gripping, collapsing, pulling, and deploying steps for forming another folded flap of tissue and deploying at least one other fastener displaced from the at least one fastener.  
     
     
         14 . The method of  claim 10 , further comprising inflating the stomach before deploying the at least one fastener.  
     
     
         15 . The method of  claim 10 , further comprising releasing the grip on the stomach tissue after the at least one fastener is deployed.  
     
     
         16 . The method of  claim 10 , further comprising inflating the stomach before gripping the stomach tissue.  
     
     
         17 . The method of  claim 16 , comprising the further step of re-inflating the stomach prior to deploying the at least one fastener.  
     
     
         18 . The method of  claim 10 , further comprising, before the gripping step, inflating the stomach to a first pressure, visualizing the stomach from within the stomach, and inflating the stomach to a second pressure, the second pressure being greater than the first pressure.  
     
     
         19 . The method of  claim 18 , wherein the stomach is associated with an esophagus and wherein the method further comprises gripping a wall of the esophagus after inflating the stomach to the first pressure and prior to gripping the stomach.  
     
     
         20 . The method of  claim 18 , comprising the further step of re-inflating the stomach prior to deploying the at least one fastener.  
     
     
         21 . The method of  claim 18 , further comprising repeating the inflating, gripping, collapsing, pulling, and deploying steps for forming another folded flap of tissue and deploying at least one other fastener displaced from the at least one fastener.  
     
     
         22 . The method of  claim 21 , further comprising measuring from the folded flap of tissue prior to repeating the gripping step.  
     
     
         23 . The method of  claim 10 , further comprising, before the gripping step, inflating the stomach to a first pressure, visualizing the stomach from within the stomach, and increasing inflation pressure within the stomach to a second pressure after visualizing the stomach.  
     
     
         24 . The method of  claim 23 , wherein the stomach is associated with an esophagus and wherein the method further comprises gripping a wall of the esophagus after inflating the stomach to the first pressure and prior to gripping the stomach.  
     
     
         25 . The method of  claim 23 , comprising the further step of re-inflating the stomach prior to deploying the at least one fastener.  
     
     
         26 . The method of  claim 23 , further comprising repeating the inflating, increasing, gripping, collapsing, pulling, and deploying steps for forming another folded flap of tissue and deploying at least one other fastener displaced from the at least one fastener.  
     
     
         27 . The method of  claim 26 , further comprising measuring from the folded flap of tissue prior to repeating the gripping step.  
     
     
         28 . A method of gripping stomach tissue from within a stomach, comprising: 
 visualizing the stomach from within the stomach to determine a gripping location;    inflating the stomach; and    gripping the stomach at the gripping location while the stomach is inflated.    
     
     
         29 . The method of  claim 28 , wherein the inflating step includes inflating the stomach to a first pressure before the visualizing step and increasing inflation pressure to a second pressure before the gripping step.  
     
     
         30 . The method of  claim 29 , wherein the stomach is associated with an esophagus and wherein the method further comprises gripping a wall of the esophagus after inflating the stomach to the first pressure and prior to gripping the stomach.  
     
     
         31 . An assembly for restoring a gastroesophageal flap valve associated with a stomach, comprising: 
 an elongated member having a distal end for placement in the stomach; and    a gastroesophageal flap valve restoration device including a chassis and a bail carried at the elongated member distal end, the chassis having a proximal end connected to the elongated member distal end and a distal end hingedly coupled to the bail, the chassis and bail arranged to mold stomach tissue there between, the chassis further including a window that permits gastroesophageal anatomy visualization.    
     
     
         32 . The apparatus of  claim 31 , wherein the window is at the proximal end of the chassis.  
     
     
         33 . The apparatus of  claim 32 , wherein the device further comprises a passage that slidingly receives an endoscope adjacent the window.  
     
     
         34 . The apparatus of  claim 31 , wherein the device further includes a fastener deployment guide having a predetermined orientation relative to the window.  
     
     
         35 . The apparatus of  claim 34 , wherein the fastener deployment guide comprises at least one guide lumen.  
     
     
         36 . The apparatus of  claim 31 , wherein the window includes a location marker.  
     
     
         37 . The apparatus of  claim 36 , wherein the device further includes a fastener deployment guide that guides a fastener into molded tissue.  
     
     
         38 . The apparatus of  claim 37 , wherein the deployment guide has a predetermined orientation relative to the location marker.  
     
     
         39 . The apparatus of  claim 36  further comprising a fastener deployer that deploys a fastener in molded tissue at a predetermined location relative to the location marker.  
     
     
         40 . A method of deploying a fastener through stomach tissue a predetermined distance from a gastroesophageal junction, comprising: 
 providing a fastener deployment apparatus, the apparatus including a window permitting visualization of gastroesophageal anatomy when placed in an esophagus, a location marker viewable in the window, and a fastener deployer that ejects a fastener for deployment at a predetermined location relative to the location marker;    feeding the apparatus down the esophagus;    aligning the location marker with respect to the gastroesophageal junction to cause the fastener deployer to be aboral of the gastroesophageal junction; and    ejecting a fastener from the fastener deployer with the location marker aligned with respect to the gastroesophageal junction.    
     
     
         41 . A fastener deployment apparatus that deploys a fastener in body tissue, comprising: 
 a window permitting visualization of internal body anatomy when placed in a body;    a location marker viewable in the window; and    a fastener deployer having a predetermined orientation relative to the location marker that ejects a fastener for deployment at a predetermined location relative to the location marker.    
     
     
         42 . A device for folding tissue, comprising a chassis and a bail, the chassis having a distal end hingedly coupled to the bail, the chassis and bail arranged to fold tissue there between, the chassis further including a window that permits anatomy visualization.