Tissue fixation devices and a transoral endoscopic gastroesophageal flap valve restoration device and assembly using same

Abstract

Tissue fasteners carried on a tissue piercing deployment wire fasten tissue layers of a mammalian body together. The fasteners include a first member, a second member, and a connecting member extending between the first and second members. The first and second members are substantially parallel to each other. The fasteners may be deployed in limited spaces and in various applications including the restoration of a gastroesophageal flap valve.

1 .- 112 . (canceled)  
     
     
         113 . A fastener for use in a mammalian body, comprising: 
 a connecting member;    a first member having first and second ends immovably fixed to the connecting member intermediate its first and second ends; and    a second member having first and second ends immovably fixed to the connecting member intermediate its first and second ends and fixedly spaced from the first member by the connecting member;    one of the first and second members having a through channel extending from its first end to its second end substantially transverse to the connecting member, the through channel being dimensioned for slideably receiving a tissue piercing deployment wire therein.    
     
     
         114 . The fastener of  claim 113  wherein one end of the one of the first and second members further includes a pointed tip.  
     
     
         115 . The fastener of  claim 113  wherein the connecting member is flexible permitting another one of the first and second members to be next to the one of the first and second members when the one of the first and second members is on the tissue piercing deployment wire.  
     
     
         116 . The fastener of  claim 113  wherein each of the first and second members has a through channel extending from its first end to its second end substantially transverse to the connecting member, each through channel being dimensioned for slideably receiving a tissue piercing deployment wire therein.  
     
     
         117 . The fastener of  claim 116  wherein one end of both the first and second members includes a pointed tip.  
     
     
         118 . The fastener of  claim 116  wherein the connecting member has sufficient flexibility to permit the first and second members to be in line with each other on the tissue piercing deployment wire.  
     
     
         119 . The fastener of  claim 113  wherein the fastener is at least partially radio opaque.  
     
     
         120 . The fastener of  claim 113  wherein the connecting member is formed of elastic material.  
     
     
         121 . The fastener of  claim 113  wherein the first member, the second member, and the connecting member are all formed of plastic material.  
     
     
         122 . The fastener of  claim 121  wherein the first member, the second member, and the connecting member are all formed in one piece.  
     
     
         123 . The fastener of  claim 121  wherein the connecting member is formed of a plastic, permanently deformable material.  
     
     
         124 . The fastener of  claim 121  wherein the plastic material includes a color pigment contrasting with body tissue color to enable visualization of the fastener with an endoscope.  
     
     
         125 . The fastener of  claim 122  wherein the connecting member has a vertical dimension and a horizontal dimension transverse to the vertical dimension, and wherein the horizontal dimension is substantially less than the vertical dimension rendering the connecting member readily bendable in a horizontal plane.  
     
     
         126 . The fastener of  claim 113  further comprising a plurality of the connecting members extending between the first and second members.  
     
     
         127 . The fastener of  claim 113  wherein the first and second members and the connecting member are formed of different materials.  
     
     
         128 . The fastener of  claim 113  wherein the first and second members and the connecting member have different textures.  
     
     
         129 . The fastener of  claim 113  wherein the first member, the second member, and the connecting member are integrally formed from a same tubular member stock.  
     
     
         130 . The fastener of  claim 129  wherein both the first and second members include a through channel for being slidingly received in line on the tissue piercing deployment wire.  
     
     
         131 . The fastener of  claim 130  wherein the fastener is formed of metal.  
     
     
         132 . The fastener of  claim 130  wherein the fastener is formed of a shape memory material and wherein the first and second members are self-deployable.  
     
     
         133 . The fastener of  claim 132  wherein the fastener is formed of nitinol.  
     
     
         134 . The fastener of  claim 130  wherein at least one of the first and second members is self-deployable while on the tissue piercing deployment wire.  
     
     
         135 . The fastener of  claim 130  wherein at least one of the first and second members is self-deployable upon removal from the tissue piercing deployment wire.  
     
     
         136 . The fastener of  claim 135  wherein the at least one of the first and second members includes a restrictor that provides a controlled resistance to movement between the fastener and the tissue piercing deployment wire.  
     
     
         137 . The fastener of  claim 136  wherein the restrictor comprises a crimp.  
     
     
         138 . The fastener of  claim 113  wherein the fastener is formed of a shape memory material.  
     
     
         139 . The fastener of  claim 138  wherein the shape memory material is a metal.  
     
     
         140 . The fastener of  claim 138  wherein the shape memory material is Nitinol.  
     
     
         141 . A fastener assembly for use in a mammalian body, comprising: 
 a fastener including a connecting member, a first member having first and second ends immovably fixed to the connecting member intermediate its first and second ends, and a second member having first and second ends immovably fixed to the connecting member intermediate its first and second ends and fixedly spaced from the first member by the connecting member, wherein one of the first and second members has a through channel extending from its first end to its second end substantially transverse to the connecting member, and the through channel being dimensioned for slideably receiving a tissue piercing deployment wire therein;    a deployment wire that slidingly receives the through channel of the one of the first and second members and pierces into the tissue; and    a pusher that pushes the one of first and second members into the tissue while on the deployment wire.    
     
     
         142 . The assembly of  claim 141  wherein the pusher is also arranged to be slidingly received on the deployment wire.  
     
     
         143 . The assembly of  claim 141  wherein the connecting member of the fastener is flexible, and wherein the assembly further comprises a guide tube extending over the deployment wire and the fastener, the other one of the first and second members being disposed next to the one of the first and second members within the guide tube.  
     
     
         144 . The assembly of claim  47  wherein the first and second members are arranged to be side by side when the one of the first and second members is slidingly received on the deployment wire.  
     
     
         145 . The assembly of  claim 141  wherein one end of the one of the first and second members of the fastener further includes a pointed tip.  
     
     
         146 . The assembly of  claim 141  wherein each of the first and second members has a through channel extending from its first end to its second end substantially transverse to the connecting member, and each through channel being dimensioned for slideably receiving a tissue piercing deployment wire therein;  
     
     
         147 . The assembly of  claim 146  wherein one end of each of the first and second members includes a pointed tip.  
     
     
         148 . The assembly of  claim 147  wherein the pointed tips point in opposite directions.  
     
     
         149 . The assembly of  claim 146  wherein the through channels of the first and second members are arranged to be slidingly received by the tissue piercing deployment wire and wherein the connecting member is flexible permitting the first and second members to be in line with each other on the tissue piercing deployment wire.  
     
     
         150 . The assembly of  claim 149  further comprising a guide tube extending over the deployment wire and the fastener.  
     
     
         151 . The assembly of  claim 141  wherein the first member, the second member, and the connecting member of the fastener are all formed of plastic material.  
     
     
         152 . The assembly of claim  15 . 1  wherein the first member, the second member, and the connecting member of the fastener are all formed in one piece.  
     
     
         153 . The assembly of  claim 141  wherein one end of the one of the first and second members of the fastener further includes a dilation tip.  
     
     
         154 . The assembly of  claim 141  wherein the connecting member of the fastener is formed of plastic elastic material.  
     
     
         155 . The assembly of  claim 141  wherein the connecting member of the fastener is formed of a plastic, permanently deformable material.  
     
     
         156 . The assembly of  claim 151  wherein the plastic material includes a color pigment contrasting with body tissue color to enable visualization of the fastener with an endoscope.  
     
     
         157 . The assembly of  claim 141  wherein the connecting member of the fastener has a vertical dimension and a horizontal dimension transverse to the vertical dimension, and wherein the horizontal dimension is substantially less than the vertical dimension rendering the connecting member readily bendable in a horizontal plane.  
     
     
         158 . The assembly of  claim 141  wherein the first member, the second member, and the connecting member of the fastener are integrally formed from a same tubular member stock.  
     
     
         159 . The assembly of  claim 158  wherein both the first and second members of the fastener include a through channel for being slidingly received in line on the tissue piercing deployment wire.  
     
     
         160 . The assembly of  claim 141  wherein the fastener is formed of metal.  
     
     
         161 . The assembly of  claim 141  wherein the fastener is formed of a shape memory material and wherein the first and second members are self-deployable.  
     
     
         162 . The assembly of  claim 141  wherein the fastener is formed of Nitinol.  
     
     
         163 . The assembly of  claim 159  wherein at least one of the first and second members of the fastener is self-deployable while on the tissue piercing deployment wire.  
     
     
         164 . The assembly of  claim 159  wherein at least one of the first and second members of the fastener is self-deployable upon removal from the tissue piercing deployment wire.  
     
     
         165 . The assembly of  claim 164  wherein the at least one of the first and second members of the fastener is distal to another one of the first and second members and wherein the another one of the first and second members includes a crimp that provides a controlled resistance to movement on the tissue piercing deployment wire.  
     
     
         166 . The assembly of  claim 141  further comprising a guide tube extending over the deployment wire and fastener and wherein the guide tube includes a distal notch permitting a proximal one of the first and second members to deploy before the guide tube proximally clears the proximal member.  
     
     
         167 . The assembly of  claim 166  wherein the proximal one of the first and second members is deployable while on the deployment wire.  
     
     
         168 . The assembly of  claim 141  wherein the deployment wire includes a bent tip.  
     
     
         169 . The assembly of  claim 141  further comprising a plurality of the fasteners slidingly received on the deployment-wire.