Patent foramen ovale closure system

Abstract

A patent foramen ovale closure device, method of delivering and a delivery system are provided. The device may include a closure device releasably connectable to an actuator. The device may include a proximal segment, an intermediate segment and a distal segment. When delivered, the proximal segment and intermediate segment form a first clip-shaped portion sized and configured to be positioned over a septum secundum of the patent foramen ovale, and the intermediate segment and distal segment form a second clip-shaped portion sized and configured to be positioned over a septum primum of the patent foramen ovale.

1 - 7 . (canceled) 
     
     
         8 . A system for closing a patent foramen ovale with an overlapping septum primum and a septum secundum, comprising:
 a delivery catheter having a lumen extending therethrough;   a closure device configured for being configured for placement in the opening in the heart and for collapsible containment within the lumen, the closure device comprising:
 a wire; 
 an anterior section; 
 a posterior section; 
 at least one loop; 
 at least one wing configured to anchor the device into heart tissue; and 
 a tether extending through the at least one loop, the tether configured to releasably retain the closure device with the delivery catheter. 
   
     
     
         9 . The system for closing a patent foramen ovale of  claim 8 , wherein the tether extends through the lumen and is detachable from the at least one loop. 
     
     
         10 . The system for closing a patent foramen ovale of  claim 8 , wherein the closure device is self-expandable. 
     
     
         11 . The system for closing a patent foramen ovale of  claim 8 , wherein the wire, anterior section, posterior section and at least one loop are integral. 
     
     
         12 . The system for closing a patent foramen ovale of  claim 8 , wherein the wire comprises Nitinol. 
     
     
         13 . The system for closing a patent foramen ovale of  claim 8 , wherein the wire comprises stainless steel. 
     
     
         14 . The system for closing a patent foramen ovale of  claim 8 , the wings extending beyond the overlapping septum primum and a septum secundum of the patent foramen ovale to provide additional support to closure device. 
     
     
         15 . The system for closing a patent foramen ovale of  claim 8 , further comprising a material attached to the closure device configured to facilitate cellular in-growth. 
     
     
         16 . A system for closing a defect in a human heart, comprising:
 a wire frame having expandable anterior and posterior sections, wherein the wire frame is biased to be expanded such that the anterior and posterior sections engage tissue on opposite sides of the defect, and the wire frame is configured to be retrieved by collapsing the wire frame;   at least one loop in the anterior section of the wire frame;   at least one wing configured to anchor the device into heart tissue; and   a tether passing through the at least one loop; and   a delivery catheter having a lumen for delivering the wire frame in a collapsed configuration to the defect.   
     
     
         17 . The system of  claim 16 , wherein the posterior section includes a plurality of loops extending radially outwardly. 
     
     
         18 . The system of  claim 16 , further comprising a material on at least a portion of the wire frame configured to promote tissue growth. 
     
     
         19 . The system of  claim 18 , wherein the material is formed of a relatively porous material for permitting ingrowth of collagen or fibrous tissue into the material. 
     
     
         20 . The system of  claim 16 , comprising a plurality of loops in the anterior section of the wire frame and a plurality of tethers passing through the loops. 
     
     
         21 . A tissue opening occluder for placement in an area formed by overlapping atrial septa of a patent foramen ovale (PFO), the overlapping atrial septa forming a PFO tunnel, the PFO tunnel having a generally planar geometry along a length of the tunnel from the left atrium to the right atrium, the tissue opening occluder comprising:
 a planar support structure sized and configured to be deployed into position within the PFO tunnel between the overlapping atrial septa with a planar portion of the planar support structure configured to be generally parallel with a tissue wall extending along a length of the PFO tunnel from the left atrium to the right atrium, the planar portion comprising a first substantially planar tissue engaging side and a second substantially planar tissue engaging side, the planar portion having a flat configuration defined between the first and second substantially planar tissue engaging sides;   at least one wing configured to anchor the device into heart tissue; and   a material supported by the planar support structure and sized and configured to be positioned within the PFO tunnel between the overlapping atrial septa, the material promoting tissue growth to anchor the occluder in intimate contact with a tissue wall.   
     
     
         22 . The tissue opening occluder of  claim 21 , wherein the material is porous. 
     
     
         23 . The tissue opening occluder of  claim 21 , wherein the support structure is made of metal wire. 
     
     
         24 . The tissue opening occluder of  claim 21 , wherein the planar support structure further comprises at least one loop selectively attachable to a tether. 
     
     
         25 . The tissue opening occluder of  claim 21 , wherein the planar support structure further comprises wings configured to anchor the support structure into heart tissue.