Apparatus and method for securing the stomach to the diaphragm for use, for example, in treating hiatal hernias and gastroesophageal reflux disease

Abstract

A patient's stomach may be secured to the patient's diaphragm. A method to accomplish this includes visualizing a wall of a patient's stomach adjacent the patient's diaphragm from within the patient's stomach, inserting a fastener deployment apparatus down the patient's esophagus and into the mammalian's stomach, and fastening the patient's stomach to the patient's diaphragm with the fastener deployment apparatus and from within the stomach. The procedure may be employed to advantage to treat a hiatal hernia, for example, either alone or in conjunction with the restoration of the patient's gastroesophageal flap valve.

1 . A method comprising: 
 visualizing a wall of a patient's stomach adjacent the patient's diaphragm from within the patient's stomach;    inserting a fastener deployment apparatus down the patient's esophagus and into the mammalian's stomach; and    fastening the patient's stomach to the patient's diaphragm with the fastener deployment apparatus and from within the stomach.    
     
     
         2 . The method of  claim 1 , wherein the fastening step includes fastening the patient's stomach to the crus of the patient's diaphragm.  
     
     
         3 . The method of  claim 1 , wherein the fastening step includes fastening the patient's stomach to the right crus of the patient's diaphragm.  
     
     
         4 . The method of  claim 1 , wherein the fastening step includes fastening the fundus of the patient's stomach to the patient's diaphragm.  
     
     
         5 . An assembly comprising: 
 an elongated member including a proximal end and a distal end;    a fastener deployer carried at the distal end of the elongated member, the elongated member and fastener deployer being arranged to feed the fastener deployer down a throat and esophagus into a stomach, the fastener deployer being further arranged to fasten the stomach to an adjacent diaphragm; and    a visualization device that enables visualization of the stomach being fastened to the adjacent diaphragm.    
     
     
         6 . The assembly of  claim 5 , wherein the fastener deployer is arranged to fastener the stomach to the right crus of the diaphragm.  
     
     
         7 . The assembly of  claim 5 , wherein the fastener deployer is arranged to fasten the fundus of the stomach to the diaphragm.  
     
     
         8 . The assembly of  claim 7 , wherein the fastener deployer comprises an elongated arm that positions the fastener deployer spaced away from the esophageal opening to the stomach and in contact with the fundus.  
     
     
         9 . The assembly of  claim 5 , wherein the visualization device comprises an endoscope.  
     
     
         10 . The assembly of  claim 5 , wherein the elongated member includes a guide that guides the visualization device into the stomach.  
     
     
         11 . The assembly of  claim 5 , wherein the fastener deployer includes at least one fastener to be deployed, the fastener comprising a first member, a second member, the first and second members having first and second ends, and 
 a connecting member fixed to each of the first and second members intermediate the first and second ends and extending between the first and second members, wherein    the first and second members are separated by the connecting member, and wherein one of the first and second members has a through channel along the axis arranged to be slidingly received on a tissue piercing deployment wire.    
     
     
         12 . The assembly of  claim 11  wherein the fastener further comprises a slit extending between the first and second ends and communicating with the through channel.  
     
     
         13 . The assembly of  claim 11 , wherein the fastener deployer further comprises a deployment wire arranged to be slidingly received by the through channel of the one of the first and second members, to pierce into the tissue to be fastened, and to guide the fastener into the tissue.  
     
     
         14 . The assembly of  claim 13 , wherein the fastener deployer further comprises a pusher that pushes the one of first and second members into the tissue while on the deployment wire.  
     
     
         15 . The assembly of  claim 13 , wherein the fastener deployer further comprises a guide tube extending over the deployment wire and the fastener that guides the deployment wire and fastener to the tissue.  
     
     
         16 . The assembly of  claim 15 , wherein the fastener deployer further comprises an elongated arm that supports and positions the guide tube spaced away from the esophageal opening to the stomach and in proximity with fundus of the stomach.  
     
     
         17 . A method of treating a stomach disorder comprising: 
 providing a transoral gastroesophageal valve restoration device;    feeding the device down the esophagus into the stomach;    forming a gastroesophageal valve with the device from within the stomach;    fastening stomach tissue to maintain the gastroesophageal valve; and    securing the stomach to the diaphragm from within the stomach.    
     
     
         18 . The method of  claim 17 , wherein the step of securing the stomach to the diaphragm includes fastening the stomach to the right crus of the diaphragm.  
     
     
         19 . The method of  claim 17 , wherein the step of securing the stomach to the diaphragm includes fastening fundus of the stomach to the diaphragm.  
     
     
         20 . The method of  claim 17  further comprising gripping the esophagus and displacing the esophagus until the stomach is completing within the diaphragm before securing the stomach to the diaphragm.  
     
     
         21 . The method of  claim 20  wherein the steps of gripping the esophagus and displacing the esophagus until the stomach is completely within the diaphragm are performed before the step of forming a gastroesophageal valve with the device from within the stomach.  
     
     
         22 . A method of treating a hiatal hernia of a patient associated with the patient's esophagus, stomach, and diaphragm, the method comprising the steps of: 
 gripping the esophagus;    displacing the esophagus towards the diaphragm until the stomach is completely within the diaphragm; and    securing the stomach to the diaphragm,    wherein the gripping, displacing, and securing steps are performed transorally.    
     
     
         23 . The method of  claim 22 , wherein the step of securing the stomach to the diaphragm includes fastening the stomach to the right crus of the diaphragm.  
     
     
         24 . The method of  claim 22 , wherein the step of securing the stomach to the diaphragm includes fastening fundus of the stomach to the diaphragm.  
     
     
         25 . The method of  claim 22 , wherein the gripping step includes gripping sidewalls of the esophagus.  
     
     
         26 . The method of  claim 22 , wherein the gripping step includes gripping sidewalls of the esophagus with a vacuum.  
     
     
         27 . A method of treating a hiatal hernia of a patient and restoring a gastroesophageal valve of the patient, the patient having an esophagus, a diaphragm and a stomach, the method comprising the steps of: 
 gripping the esophagus;    displacing the esophagus aborally to reduce the hiatal hernia; and    manipulating tissue of the stomach while maintaining a grip on the esophagus to restore the gastroesophageal valve,    wherein the gripping, displacing, and manipulating steps are performed transorally.    
     
     
         28 . The method of  claim 27 , further comprising the step of securing the stomach to the diaphragm.  
     
     
         29 . The method of  claim 27 , wherein the manipulating step includes forming a gastroesophageal valve flap and wherein the method further comprises deploying at lease one fastener through the gastroesophageal valve flap to maintain the valve and the reduced hiatal hernia.  
     
     
         30 . The method of  claim 29  further comprising the step of securing the stomach to the diaphragm.