Single disc occlusionary patent foramen ovale closure device

Abstract

The present invention is a method and device for closing a passageway in a body, for example a patent foramen ovale (PFO) in a heart, and related methods of using such closure devices for closing the passageway.

1 . A medical device for closing a passageway in a body comprising: 
 a closure line having a first and a second end;    an expandable tissue anchor connected to the first end of the closure line, the tissue anchor being adapted to pierce into tissue within close approximation to the passageway and subsequently expand to embed into the tissue; and    an expandable flow occluder located along the second end of the closure line, the expandable flow occluder having a locking mechanism integrated therein, the locking mechanism allowing the closure line to uni-axially slide through the expandable flow occluder in one direction, and prevent sliding movement in the opposite direction.    
     
     
         2 . The medical device of  claim 1  wherein the closure line is elastic.  
     
     
         3 . The medical device of  claim 1  wherein the closure line is a biocompatible filament.  
     
     
         4 . The medical device of  claim 3  wherein the biocompatible filament is a surgical suture.  
     
     
         5 . The medical device of  claim 4  wherein the surgical suture is a multifilament non-biodegradable suture.  
     
     
         6 . The medical device of  claim 4  wherein the surgical suture is a forced entangled fiber filament.  
     
     
         7 . The medical device of  claim 1  wherein at least one of the expandable tissue anchor or expandable flow occluder are made from a structurally deformable material.  
     
     
         8 . The medical device of  claim 1  wherein the expandable tissue anchor has a needle-like tip configured to pierce the tissue and at least one barb extending in a substantially radial outward direction to anchor into the tissue.  
     
     
         9 . The medical device of  claim 1  wherein the expandable tissue anchor and expandable flow occluder are self-expanding members.  
     
     
         10 . The medical device of  claim 1  wherein the expandable flow occluder is covered with a biocompatible fabric.  
     
     
         11 . The medical device of  claim 10  wherein the biocompatible fabric is made from a non-biodegradable polymeric fabric.  
     
     
         12 . The medical device of  claim 10  wherein the biocompatible fabric is made from a biodegradable polymeric fabric.  
     
     
         13 . The medical device of  claim 12  wherein the biodegradable polymeric fabric resorbs into the body as a function of time.  
     
     
         14 . The medical device of  claim 12  wherein the biodegradable polymeric fabric resorbs into the body as a function of applied stress.  
     
     
         15 . The medical device of  claim 12  wherein the biodegradable polymeric fabric resorbs into the body as a function of time and applied stress.  
     
     
         16 . The medical device of  claim 1  wherein the expandable tissue anchor and expandable flow occluder are made from a super elastic material.  
     
     
         17 . The medical device of  claim 16  wherein the super elastic material is a nickel titanium alloy.  
     
     
         18 . The medical device of  claim 16  wherein the super elastic material is a resilient polymer.  
     
     
         19 . The medical device of  claim 16  wherein the super elastic material is an elastically compressed spring temper biocompatible metal.  
     
     
         20 . The medical device of  claim 1  wherein the expandable tissue anchor and expandable flow occluder are mechanically expandable.  
     
     
         21 . The medical device of  claim 20  wherein the expandable tissue anchor and expandable flow occluder are made from a plastically deformable material.  
     
     
         22 . The medical device of  claim 21  wherein the plastically deformable material is spirally wound stainless steel.  
     
     
         23 . A method of closing a passageway in a body, the passageway having a first and a second open end, comprising: 
 locating a distal end of a closure device adjacent to the passageway, the closure device having a closure line with proximal and distal ends, an expandable tissue anchor located along the distal end of the closure line, and an expandable occluder member located along the proximal end of the closure line;    deploying the expandable tissue anchor into tissue adjacent to the passageway;    deploying the expandable occluder member adjacent to the passageway such that the expandable occluder member substantially covers the second opening to the passageway.    
     
     
         24 . The method of  claim 23  wherein deploying the expandable tissue anchor further comprises piercing a surface of the tissue with the expandable tissue anchor and expanding the tissue anchor within the tissue.  
     
     
         25 . The method of  claim 23  wherein deploying the expandable occluder member adjacent to the passageway comprises expanding the occluder member from a first configuration to a second configuration, and tensioning the occluder against the tissue to substantially cover the passageway.  
     
     
         26 . The method of  claim 26  wherein tensioning the occluder against the tissue comprises unilaterally displacing the occluder distally along the closure line.