Tissue fasteners and related deployment systems and methods

Abstract

Surgical tissue fasteners and related deployment systems and methods are disclosed. A tissue fastener used to join multiple tissue layers includes a first member, a second member, and a connecting member connecting the first and second members. In some embodiments, the first and second members are configured to expand from a delivered state to a deployed state in which the fastener secures the tissue layers together. Other tissue fastener embodiments include means for applying a substantially constant force on the tissue layers and/or means for adjusting a length of the connecting member between the first and second members.

What is claimed is:  
     
         1 . A tissue fastener used to join multiple tissue layers, comprising: 
 a proximal member configured to expand from a delivered state to a deployed state;    a distal member configured to expand from a delivered state to a deployed state; and    a connecting member connecting the proximal member to the distal member;    wherein, in the deployed state, the proximal member and the distal member secure the multiple tissue layers together.    
     
     
         2 . A tissue fastener according to  claim 1 , wherein at least one of the proximal member, the distal member, and the connecting member is formed of a shape memory material.  
     
     
         3 . A tissue fastener according to  claim 1 , wherein at least one of the proximal member and the distal member is expanded by mechanical means.  
     
     
         4 . A tissue fastener according to  claim 1 , wherein the tissue fastener is comprised of a biocompatible material.  
     
     
         5 . A tissue fastener according to  claim 1 , wherein the tissue fastener is comprised of a biocompliant material.  
     
     
         6 . A tissue fastener according to  claim 1 , wherein at least one of the proximal member, the distal member, and the connecting member includes a thrombogenic agent.  
     
     
         7 . A tissue fastener according to  claim 1 , wherein at least one of the proximal member, the distal member, and the connecting member includes a coating having a therapeutic agent.  
     
     
         8 . A tissue fastener according to  claim 7 , wherein the therapeutic agent promotes adhesion between the tissues undergoing attachment.  
     
     
         9 . A tissue fastener according to  claim 1 , wherein at least one of the proximal member, the distal member, and the connecting member is formed of bioabsorbable material.  
     
     
         10 . A tissue fastener according to  claim 1 , wherein at least one of the proximal member and the distal member includes a plurality of legs configured to extend outwardly in the deployed state.  
     
     
         11 . A tissue fastener according to  claim 1 , wherein at least one of the proximal member and the distal member includes a plurality of legs each having at least one bending portion proximal to a portion of the leg and wherein the portion of the leg is configured to extend outwardly in the deployed state.  
     
     
         12 . A tissue fastener according to  claim 1 , wherein the distal member includes a sharp edge.  
     
     
         13 . A tissue fastener according to  claim 1 , wherein the distal member comprises a sharp point.  
     
     
         14 . A tissue fastener according to  claim 1 , wherein the proximal member, the distal member, and the connecting member are formed of at least two wires interconnected in a middle portion thereof to form the connecting member.  
     
     
         15 . A tissue fastener according to  claim 14 , wherein each of the wires is essentially straight in the delivered state and bent in the deployed state.  
     
     
         16 . A tissue fastener according to  claim 1 , wherein the proximal member, the distal member, and the connecting member are formed of a single wire.  
     
     
         17 . A tissue fastener according to  claim 16 , wherein the wire is essentially straight in the delivered state and spiral-shaped in the deployed state.  
     
     
         18 . A tissue fastener according to  claim 16 , wherein the wire is essentially straight in the delivered state and includes non-straight portions in the deployed state.  
     
     
         19 . A tissue fastener according to  claim 1 , wherein at least one of the proximal member and the distal member includes a flat surface formed of a shape memory material.  
     
     
         20 . A tissue fastener according to  claim 1 , wherein at least one of the proximal member and the distal member includes a plurality of flexible members that form a cage-like structure in the deployed state.  
     
     
         21 . A tissue fastener according to  claim 1 , wherein at least one of the proximal member and the distal member includes a T-shaped member.  
     
     
         22 . A tissue fastener according to  claim 1 , wherein at least one of the proximal member, the distal member, and the connecting member includes a stent-like structure.  
     
     
         23 . A tissue fastener according to  claim 1 , wherein the connecting member is configured to exert compressive force between the distal member and the proximal member.  
     
     
         24 . A tissue fastener according to  claim 1 , wherein the connecting member is telescopic.  
     
     
         25 . A tissue fastener according to  claim 1 , wherein the connecting member includes a collapsible bellow.  
     
     
         26 . A tissue fastener according to  claim 1 , wherein the connecting member includes a ball-socket arrangement.  
     
     
         27 . A tissue fastener according to  claim 1 , wherein the connecting member includes a braided configuration.  
     
     
         28 . A tissue fastener according to  claim 1 , further comprising a hollow bore passing through at least a portion of the tissue fastener.  
     
     
         29 . A tissue fastener according to  claim 28 , wherein the bore is configured to administer an adhesion promoting agent between tissue layers.  
     
     
         30 . A tissue fastener according to  claim 1 , wherein the tissue fastener has a length sufficient to attach a wall of an esophagus to a wall of a gastric fundus.  
     
     
         31 . A delivery system configured for deployment of an expandable tissue fastener, comprising: 
 a flexible tube having a lumen configured to accommodate a tissue fastener in a contracted state;    a pusher for guiding the tissue fastener along the lumen of the tube; and    a coupling system coupled to a distal end of the pusher and configured to grasp the tissue fastener.    
     
     
         32 . A delivery system according to  claim 31 , further comprising a device for folding two walls of tissue together.  
     
     
         33 . A delivery system according to  claim 32 , wherein the tube is positioned in a lumen of the device.  
     
     
         34 . A delivery system according to  claim 31 , wherein the tube has a length sufficient enough to extend out of a body.  
     
     
         35 . A delivery system according to  claim 31 , wherein the tube includes a sharp cutting edge formed at its distal end.  
     
     
         36 . A delivery system according to  claim 31 , wherein the tube is configured to accommodate multiple tissue fasteners.  
     
     
         37 . A delivery system according to  claim 31 , further comprising actuation means for the coupling system at a proximal end of the tube.  
     
     
         38 . A delivery system according to  claim 31 , wherein the tube has a sheath covering it to puncture through tissue.  
     
     
         39 . A delivery system according to  claim 38 , wherein the sheath includes a puncturing tip.  
     
     
         40 . A delivery system according to  claim 31 , wherein a puncturing tool is delivered through the tube.  
     
     
         41 . A method of attaching a first wall of tissue to a second wall of tissue, comprising: 
 providing an expandable tissue fastener in a contracted state in a device, the tissue fastener having a proximal member and a distal member;    inserting the device into a body passage leading to the first tissue wall;    placing the device proximate a location on the first tissue wall;    passing the device through the first and second tissue walls;    advancing the tissue fastener toward an opening of the device, such that the distal member is completely protruded out of the device and expanded against the second tissue wall; and    releasing the tissue fastener, such that the proximal member is expanded against the first tissue wall.    
     
     
         42 . A method according to  claim 41 , wherein the distal member includes a sharp edge, and further comprising advancing at least a portion of the distal member out of the device, prior to passing the device through the first and second tissue walls.  
     
     
         43 . A method according to  claim 42 , further comprising penetrating the first and second tissue walls with the sharp edge.  
     
     
         44 . A method according to  claim 41 , comprising perforating the first and second tissue walls with a perforating instrument, prior to passing the device through the first and second tissue walls.  
     
     
         45 . A method according to  claim 41 , wherein the passing step includes perforating the first and second tissue walls by a sharp distal end of the device.  
     
     
         46 . A method according to  claim 41 , wherein the first tissue wall is a esophageal wall and the second tissue wall is a gastric fundus wall.  
     
     
         47 . A method according to  claim 46 , further comprising folding the fundus wall proximate to the esophageal wall.  
     
     
         48 . A method according to  claim 41 , wherein the tissue fastener punctures the fundus wall prior to puncturing the esophageal wall.  
     
     
         49 . A method according to  claim 41 , wherein the tissue fastener punctures the fundus wall and the esophageal wall at substantially the same time.  
     
     
         50 . A tissue fastener used to join multiple tissue layers, comprising: 
 a first member;    a second member;    a connecting member connecting the first member to the second member; and    means for applying a substantially constant force on the tissue layers.    
     
     
         51 . The tissue fastener of  claim 50 , wherein the applying means is compressible.  
     
     
         52 . The tissue fastener of  claim 51 , wherein the applying means includes a bellows-like structure.  
     
     
         53 . The tissue fastener of  claim 51 , wherein the applying means includes a spring.  
     
     
         54 . The tissue fastener of  claim 51 , wherein the applying means includes a balloon.  
     
     
         55 . The tissue fastener of  claim 50 , wherein the connecting member includes the applying means, and the applying means is an elongate, elastic member.  
     
     
         56 . A tissue fastener used to join multiple tissue layers, comprising: 
 a first member;    a second member;    a connecting member connecting the first member to the second member; and    means for adjusting a length of the connecting member between the first and second members.    
     
     
         57 . The tissue fastener of  claim 56 , wherein the adjusting means includes structure associated with the first member for releasably securing the connecting member to the first member.  
     
     
         58 . The tissue fastener of  claim 57 , wherein the structure is configured to restrict passage of the connecting member in a direction through the first member.  
     
     
         59 . The tissue fastener of  claim 58 , wherein the structure includes a ratchet-like mechanism.  
     
     
         60 . The tissue fastener of  claim 58 , wherein the structure includes a biased locking mechanism.  
     
     
         61 . The tissue fastener of  claim 60 , wherein the biased locking mechanism includes a spring biasing a bearing.  
     
     
         62 . The tissue fastener of  claim 58 , wherein the structure includes eccentric cams.  
     
     
         63 . The tissue fastener of  claim 56 , wherein the adjusting means includes teeth associated with the first member.  
     
     
         64 . The tissue fastener of  claim 56 , wherein the first member includes the adjusting means, and the adjusting means includes structure for inverting the first member.  
     
     
         65 . The tissue fastener of  claim 56 , wherein rotation of the first member relative to the connecting member adjusts the length of the connecting member between the first and second members.  
     
     
         66 . The tissue fastener of  claim 65 , wherein the adjusting means includes slots on the first member to accommodate the connecting member.  
     
     
         67 . The tissue fastener of  claim 56 , wherein the first member includes the adjusting means, and the adjusting means includes a dish that accommodates a corresponding disk to secure the connecting member therebetween.  
     
     
         68 . The tissue fastener of  claim 56 , wherein the adjusting means includes a notch within the first member to receive the connecting member.  
     
     
         68 . The tissue fastener of  claim 57 , wherein the structure associated with the first member cooperates with connecting member structure to adjust the length of the connecting member.  
     
     
         69 . The tissue fastener of  claim 68 , wherein the connecting member structure includes a plurality of enlargements spaced along the connecting member.  
     
     
         70 . The tissue fastener of  claim 69 , wherein the plurality of enlargements permit incremental adjustments in the length of the connecting member between the first member and the second member.  
     
     
         71 . The tissue fastener of  claim 57 , wherein the structure associated with the first member includes a torsion spring with arms.  
     
     
         72 . A tissue fastener used to join multiple tissue layers, comprising: 
 a first member;    a second member;    a connecting member connecting the first member to the second member;    wherein the connecting member includes a first portion substantially parallel to a second portion, the first and second portions extending between the first and second members and through the first member to connect and form a knot-like configuration against the first member.