Transseptal closure of a patent foramen ovale and other cardiac defects

Abstract

The present invention provides for therapeutic treatment methods, devices, and systems for the partial or complete closure or occlusion of a patent foramen ovale (“PFO”). In particular, various methods, devices, and systems for joining or welding tissues, in order to therapeutically close a PFO are described. In yet another aspect of the invention, various methods, devices, and systems for the penetration of the interatrial septum enabling left atrial access are also provided.

1 . A treatment method for closing a patent foramen ovale comprising two flap-like tissue structures and which is located on an interatrial septum separating a right and left atrium of a heart; said method comprising the steps of: 
 a) detecting and locating the patent foramen ovale;    b) encasing the two flap-like tissue structures between one or more heat generating members;    b) energizing the one or more heat generating means; and    c) applying a therapeutic amount of energy to join the two overlapping tissue structures at one or more positions of contact.    
   
   
       2 . The method of  claim 1 , wherein the therapeutic amounts of energy is produced by a proximal heat generating member located in the right atrium of the heart.  
   
   
       3 . The method  claim 1 , wherein the therapeutic amounts of energy is produced by a distal heat generating member located in the left atrium of the heart.  
   
   
       4 . The method of  claim 3 , wherein the therapeutic amounts of energy are simultaneously produced by the proximal heat generating member located in the right atrium and the distal heat generating member located within the left atrium.  
   
   
       5 . The method of  claim 4 , wherein the proximal and distal heat generating members are transseptally deployed.  
   
   
       6 . The method of  claim 3  or  4 , further comprising the step of: penetrating the interatrial septum of the heart and forming a left atrial access pathway.  
   
   
       7 . The method of  claim 1 ,  2 ,  3 , or  4 , wherein the tissues are joined at the one or more points of contact.  
   
   
       8 . The method of  claim 1 ,  2 ,  3 , or  4 , wherein the one the tissue are joined along a seam.  
   
   
       9 . The method of  claim 1 ,  2 ,  3 , or  4 , wherein the PFO is partially closed.  
   
   
       10 . The method of  claim 1 ,  2 ,  3 , or  4 , wherein the PFO is completely closed.  
   
   
       11 . The method of  claim 1 ,  2 ,  3 , or  4 , wherein the two overlapping tissue structures are permanently joined.  
   
   
       12 . The method of  claim 1 , further comprising the step of: applying a lubricating means to prevent sticking of the tissues to the one or more heat generating means.  
   
   
       13 . The method of  claim 12 , wherein the lubricating means is electrically conductive.  
   
   
       14 . The method of  claim 13 , further comprising the step of: providing a monitoring means to prevent overheating of cardiac tissues adjacent the encased tissues.  
   
   
       15 . A treatment method for therapeutically closing a patent foramen ovale on an interatrial septum separating a right and left atrium of the heart, said treatment method comprising the steps of: 
 a) determining the location of the patent foramen ovale; and    b) applying therapeutic amounts of energy to the septum at or near the location determined in step (a) to induce.    
   
   
       16 . The method of  claim 15 , wherein the therapeutic amount of energy is applied from the right atrium of the heart.  
   
   
       17 . The method of  claim 15 , further comprising the step of: 
 a) puncturing the septum on or near the patent foramen ovale and creating an access pathway into the left atrium of the heart.    
   
   
       18 . The method of  claim 17 , further comprising the steps of: introducing the first heat generating member into the right atrium; and introducing a second heat generating member into the left atrium of the heart.  
   
   
       19 . The method of  claim 18 , further comprising the step of: energizing the first heat generating member.  
   
   
       20 . The method of  claim 18 , wherein the first and second heating means are energized simultaneously.  
   
   
       21 . The method of  claim 18 , wherein the first and second heating means are used in order to apply a compressive force to the septum encased between the first and second heating means.  
   
   
       22 . The method of  claim 18 , further comprising the step of: introducing a lubricating means to prevent sticking of the septum to the first and second heating means.  
   
   
       23 . The method of  claim 22 , wherein the lubricating means is also electrically conductive.  
   
   
       24 . A catheter apparatus for closing a patent foramen ovale comprised of two overlapping tissue structures located on an interatrial septum which separates a right and left atrium of the heart, said apparatus comprising: 
 a) a means for locating and detecting the patent foramen ovale;    b) a means for puncturing the interatrial septum at, or adjacent, the patent foramen ovale; and    c) one or more means for transseptally delivering therapeutic amounts of energy one or more tissue locations in order to affect joining of the overlapping tissue structures.    
   
   
       25 . The apparatus of  claim 24 , wherein the one or more means for applying compressive force to the interatrial septum.  
   
   
       26 . The apparatus of  claim 25 , further comprising one or more radio-opaque means.