Flexible transoral endoscopic gastroesophageal flap valve restoration device and method

Abstract

A transoral gastroesophageal flap valve restoration device has sufficient flexibility and dimension to be passed through the mouth, throat, and esophagus of a patient into the patient's stomach. The device includes a first member and a second member hingedly coupled to the first member. The first and second members are configured to flex in a direction to follow the esophageal path into the stomach and to be substantially rigid when forming the restored gastroesophageal flap valve.

1 . A transoral gastroesophageal flap valve restoration device comprising: 
 a first member; and    a second member hingedly coupled to the first member, the first and second members being arranged for esophageal passage into a stomach to receive stomach tissue there between to form a flap of a gastroesophageal flap valve,    the first and second members being configured to flek in a direction to follow an esophageal path into the stomach and to be substantially rigid when receiving the stomach tissue there between and forming the flap of the gastroesophageal flap valve.    
     
     
         2 . The device of  claim 1  wherein the first member includes a compression assembly that selectively renders the first member substantially rigid.  
     
     
         3 . The device of  claim 1  wherein each of the first and second members has a length greater than three centimeters.  
     
     
         4 . The device of  claim 1  wherein each of the first and second members has a length between three and five centimeters.  
     
     
         5 . The device of  claim 1  wherein the first and second members are arranged to be substantially in line with each other when in the esophageal path.  
     
     
         6 . The device of  claim 1  wherein at least one of the first and second members has an arcuate cross section.  
     
     
         7 . The device of  claim 6  wherein both the first and second members has an arcuate cross section.  
     
     
         8 . The device of  claim 1  wherein one of the first and second members has a longitudinal dimension and wherein the one of the first and second members includes a plurality of slots substantially transverse to the longitudinal dimension of the one of the first and second members.  
     
     
         9 . The device of  claim 8  further comprising a flexible sheath overlying at least the one of the first and second members.  
     
     
         10 . The device of  claim 8  further comprising a flexible filler material within the slots.  
     
     
         11 . The device of  claim 10  wherein the filler material has a lower durometer than the one of the first and second members.  
     
     
         12 . The device of  claim 8  wherein the plurality of slots comprises a first set of slots and a second set of slots, the first and second sets of slots being juxtaposed, and the slots of the first set of slots being wider than the slots of the second set of slots.  
     
     
         13 . The device of  claim 8  wherein the first member includes the plurality of slots and further includes a compression assembly that closes the second set of slots and selectively renders the first member substantially rigid.  
     
     
         14 . The device of  claim 13  further comprising a pulley that hingedly couples the second member to the first member and a control cable wrapped about the pulley for pivoting the second member with respect to the first member, wherein the compression assembly includes the control cable, and wherein the compression assembly places the first member in compression upon pulling of the control cable.  
     
     
         15 . The device of  claim 14  wherein the control cable forms a pair of control extensions extending from the pulley, and wherein the control extensions extend adjacent the second plurality of shots.  
     
     
         16 . The device of  claim 1  wherein one of the first and second members comprises a plurality of links and a plurality of hinges hingedly coupling the links together.  
     
     
         17 . The device of  claim 16  wherein the hinges are arranged for limited pivotal movement to render the one of the first and second members substantially rigid.  
     
     
         18 . The device of  claim 17  wherein the first member includes a plurality of transverse slots and the second member includes the plurality of links.  
     
     
         19 . The device of  claim 18  wherein the first member includes a compression assembly that closes certain ones of the transverse slots to render the first member substantially rigid.  
     
     
         20 . The device of  claim 19  further comprising a pulley that hingedly couples the second member to the first member and a control cable wrapped about the pulley for pivoting the second member with respect to the first member, the compression assembly including the control cable, and wherein the compression assembly places the first member in compression upon pulling of the control cable.  
     
     
         21 . The device of  claim 1  wherein the second member is distal to the first member, wherein the second member has a longitudinal dimension, a transverse dimension, and a tip end, and wherein the tip end of the second member includes a hinge to permit folding of the tip end to reduce the transverse dimension of the second member tip end.  
     
     
         22 . An assembly for restoring a gastroesophageal flap valve comprising: 
 a longitudinal member having an end arranged for placement in a stomach; and    a transoral gastroesophageal flap valve restoration device carried at the end of the longitudinal member and including a first member, and a second member hingedly coupled to the first member, the first and second members being arranged for esophageal passage into a stomach to receive stomach tissue there between to form a flap of a gastroesophageal flap valve,    the first and second members being configured to flex in a direction to follow an esophageal path into the stomach and to be substantially rigid when receiving the stomach tissue there between and forming the flap of the gastroesophageal flap valve.    
     
     
         23 . The device of  claim 22  wherein the first member includes a compression member that selectively renders the first member substantially rigid.  
     
     
         24 . The assembly of  claim 22  wherein each of the first and second members has a length greater than three centimeters.  
     
     
         25 . The assembly of  claim 22  wherein each of the first and second members has a length between three and five centimeters.  
     
     
         26 . The assembly of  claim 22  wherein the first and second members are arranged to be substantially in line with each other when in the esophageal path.  
     
     
         27 . The assembly of  claim 22  wherein at least one of the first and second members has an arcuate cross section.  
     
     
         28 . The assembly of  claim 27  wherein both the first and second members has an arcuate cross section.  
     
     
         29 . The assembly of  claim 22  wherein one of the first and second members has a longitudinal dimension and wherein the one of the first and second members includes a plurality of slots substantially transverse to the longitudinal dimension of the one of the first and second members.  
     
     
         30 . The assembly of  claim 29  further comprising a flexible sheath overlying at least the one of the first and second members.  
     
     
         31 . The assembly of  claim 29  further comprising a flexible filler material within the slots.  
     
     
         32 . The assembly of  claim 31  wherein the filler material has a lower durometer than the one of the first and second members.  
     
     
         33 . The assembly of  claim 29  wherein the plurality of slots comprises a first set of slots and a second set of slots, the first and second sets of slots being juxtaposed, and the slots of the first set of slots being wider than the slots of the second set of slots.  
     
     
         34 . The device of  claim 29  wherein the first member includes the plurality of slots and further includes a compression assembly that closes the second set of slots and selectively renders the first member substantially rigid.  
     
     
         35 . The device of  claim 34  further comprising a pulley that hingedly couples the second member to the first member and a control cable wrapped about the pulley for pivoting the second member with respect to the first member, wherein the compression assembly includes the control cable, and wherein the compression assembly places the first member in compression upon pulling of the control cable.  
     
     
         36 . The device of  claim 35  wherein the control cable forms a pair of control extensions extending from the pulley, and wherein the control extensions extend adjacent the first plurality of shots.  
     
     
         37 . The device of  claim 22  wherein one of the first and second members comprises a plurality of links and a plurality of hinges hingedly coupling the links together.  
     
     
         38 . The device of  claim 37  wherein the hinges are arranged for limited pivotal movement to render the one of the first and second members substantially rigid.  
     
     
         39 . The device of  claim 38  wherein the first member includes a plurality of transverse slots and the second member includes the plurality of links.  
     
     
         40 . The device of  claim 39  wherein the first member includes a compression assembly that closes certain ones of the transverse slots to render the first member substantially rigid.  
     
     
         41 . The device of  claim 40  further comprising a pulley that hingedly couples the second member to the first member and a control cable wrapped about the pulley for pivoting the second member with respect to the first member, the compression assembly including the control cable, and wherein the compression assembly places the first member in compression upon pulling of the control cable.  
     
     
         42 . The device of  claim 22  wherein the second member is distal to the first member, wherein the second member has a longitudinal dimension, a transverse dimension, and a tip end, and wherein the tip end of the second member includes a hinge to permit folding of the tip end to reduce the transverse dimension of the second member tip end.  
     
     
         43 . A method of restoring a gastroesophageal flap valve comprising: 
 providing a transoral gastroesophageal flap valve restoration device comprising a first member and a second member hingedly coupled to the first member, the first and second members being flexible for esophageal passage into a stomach and substantially rigid to receive stomach tissue there between to form a flap of a gastroesophageal flap valve when in a second orientation;    feeding the device down the esophagus into the stomach with the device in a flexible condition, rendering the device substantially rigid; and    pulling stomach tissue between the first and second members to form the flap of the gastroesophageal flap valve.    
     
     
         44 . A method of restoring a gastroesophageal flap valve comprising: 
 providing a transoral gastroesophageal flap valve restoration device arranged for esophageal passage into a stomach when in a substantially flexible condition and to receive stomach tissue to form a flap of a gastroesophageal flap valve when in a substantially rigid condition;    feeding the device down the esophagus into the stomach with the device in the substantially flexible condition;    rendering the device into the substantially rigid condition; and    pulling stomach tissue into the device to form the flap of the gastroesophageal flap valve.    
     
     
         45 . A transoral gastroesophageal flap valve restoration device, the device being selectively flexible during mouth, throat, and esophagus passage into a stomach, and selectively comparatively rigid during folding of stomach tissue into a restored gastroesophageal flap.