Patent foramen ovale (PFO) closure method and device

Abstract

The present invention provides methods and devices for closing two overlapping layers of tissue in a mammalian heart, for example a patent foramen ovale (PFO). The closure devices may take a number of different forms and may be retrievable. In some embodiments, a device is sized and shaped to extend from septum secundum, into the left atrium, through septum primum, and into the right atrium, such that the first and second ends cooperate to provide a compressive force to the overlapping layers of tissue. In some embodiments, the closure devices may be delivered with a catheter capable of puncturing mammalian tissue.

1 . A device for closing two overlapping layers of septum primum and septum secundum dividing a left atrium and a right atrium in a mammalian heart, said device having first and second ends, wherein said device is sized and shaped to extend from septum secundum, into the left atrium, through septum primum, and into the right atrium, said first and second ends cooperating to provide a compressive force to the overlapping layers of tissue.  
     
     
         2 . The device of  claim 1 , wherein said first end is embedded in, and does not extend through, septum secundum.  
     
     
         3 . The device of  claim 2 , wherein said first end is formed into a coil, hook, corkscrew, or other anchor.  
     
     
         4 . The device of  claim 1 , wherein said first end includes a material selected from the group consisting of bioresorbable materials, noble metals, shape memory materials, metals, polymeric materials, and swellable foams.  
     
     
         5 . The device of  claim 4 , wherein said shape memory material includes nitinol.  
     
     
         6 . The device of  claim 1 , wherein said first end includes a septal puncture needle capable of puncturing mammalian tissue.  
     
     
         7 . The device of  claim 1 , further comprising a catheter containing said device in an elongated, low-profile form, said first end being expandable to form an anchor and said second end being adjustable to alter a compressive force applied to the overlapping layers of tissue.  
     
     
         8 . The device of  claim 1 , wherein said device is sized and shaped to further extend to septum secundum in the right atrium.  
     
     
         9 . The device of  claim 8 , wherein said device includes a ring with a gap terminating in first and second opposed, pointed ends for puncturing mammalian tissue.  
     
     
         10 . The device of  claim 9 , wherein said device includes a material selected from the group consisting of flexible polymers, bioabsorbable materials, spring metals, and shape memory materials.  
     
     
         11 . The device of  claim 10 , wherein said device includes nitinol.  
     
     
         12 . The device of  claim 9 , wherein said device consists essentially of a monolithic partial ring.  
     
     
         13 . The device of  claim 9 , wherein said device includes a gap slightly smaller than the thickness of the overlapping layers of tissue to which it is connected.  
     
     
         14 . The device of  claim 9 , wherein said device includes a gap slightly smaller than the thickness of septum secundum.  
     
     
         15 . The device of  claim 9 , wherein said first and second ends overlap each other.  
     
     
         16 . The device of  claim 1 , wherein said device includes a partial ring with first and second ends and at least one fold therebetween.  
     
     
         17 . The device of  claim 16 , wherein said at least one fold cooperates with said first and second ends to apply a compressive force to said overlapping layers of tissue.  
     
     
         18 . The device of  claim 16 , wherein said device consists essentially of a monolithic partial ring.  
     
     
         19 . The device of  claim 1 , wherein said device is sized and shaped to further contact the surfaces of septum primum exposed in both the left and right atria.