Energy based devices and methods for treatment of patent foramen ovale

Abstract

Methods and apparatus for treatment of patent foramen ovale (PFO) provide for applying energy to tissues adjacent the PFO with a catheter device to substantially close the PFO acutely. Apparatus generally includes a catheter device having at least one energy transmission member at or near its distal end configured to apply energy to PFO tissues to acutely, substantially close the PFO. Applied energy may be monopolar or bipolar radiofrequency energy or any other suitable energy, such as laser, microwave, ultrasound, resistive heating or the like. Some embodiments of a catheter device further include one or more tissue apposition members near the distal end for helping bring PFO tissues together, such as a PFO covering member, a vacuum applying member and/or the like. PFO closure via energy-based approaches of the invention may help prevent stroke, treat migraine headache, and possibly treat or prevent other medical conditions.

1 . A method for closing a patient's patent foramen ovale, comprising: 
 drawing at least one of the patient's primum and secundum toward the other, the primum and the secundum being portions of the patient's atrial septum;    applying energy to the primum and secundum; and    welding at least a portion of the primum and a portion of the secundum together to at least partially seal the patent foramen ovale.    
     
     
         2 . The method of  claim 1  wherein welding includes welding at a first location of the atrial septum, and wherein the method further includes welding at least one additional location of the atrial septum.  
     
     
         3 . The method of  claim 1  wherein welding includes spot welding the atrial septum.  
     
     
         4 . The method of  claim 1 , further comprising at least partially sealing the patent foramen ovale without leaving an implantable sealing device in the patient's heart.  
     
     
         5 . The method of  claim 1  wherein applying energy includes applying RF energy.  
     
     
         6 . The method of  claim 1  wherein applying energy includes applying sonic energy.  
     
     
         7 . The method of  claim 1  wherein drawing at least one of the patient's primum and secundum toward the other includes clamping the primum and secundum between a first electrode and a second electrode.  
     
     
         8 . The method of  claim 1  wherein welding the tissue includes melting the tissue.  
     
     
         9 . The method of  claim 1 , further comprising applying a vacuum to bring atrial septal tissue into contact with an electrode.  
     
     
         10 . The method of  claim 1 , further comprising puncturing the atrial septum.  
     
     
         11 . The method of  claim 1 , further comprising: 
 puncturing the atrial septum; and    passing at least one electrode through the punctured septum.    
     
     
         12 . The method of  claim 1  wherein applying energy to the primum and the secundum includes shrinking at least one of the primum and the secundum.  
     
     
         13 . The method of  claim 1  wherein welding the tissue includes fusing the tissue acutely.  
     
     
         14 . The method of  claim 1  wherein welding the tissue includes fusing the tissue acutely to at least partially seal the patent foramen ovale, and 
 wherein the method further comprises allowing the patient's healing process to further seal the patent foramen ovale.    
     
     
         15 . The method of  claim 1 , the method comprising closing the patient's patent foramen ovale without piercing the patient's atrial septum tissues.  
     
     
         16 . A method for closing a patient's patent foramen ovale, comprising: 
 applying a vacuum to the patient's atrial septum, the atrial septum including a    primum and a secundum;    applying energy to the primum and secundum; and    welding at least a portion of the primum and a portion of the secundum together to at    least partially seal the patent foramen ovale.    
     
     
         17 . The method of  claim 16  wherein welding includes welding at a first location of the atrial septum, and wherein the method further includes welding at least one additional location of the atrial septum.  
     
     
         18 . The method of  claim 16  wherein welding includes spot welding the atrial septum.  
     
     
         19 . The method of  claim 16 , further comprising at least partially sealing the patent foramen ovale without leaving an implantable sealing device in the patient's heart.  
     
     
         20 . The method of  claim 16  wherein applying energy includes applying RF energy.  
     
     
         21 . The method of  claim 16  wherein welding the tissue includes melting the tissue.  
     
     
         22 . The method of  claim 16  wherein applying energy to the primum and the secundum includes shrinking at least one of the primum and the secundum.  
     
     
         23 . The method of  claim 16  wherein welding the tissue includes fusing the tissue acutely.  
     
     
         24 . The method of  claim 16  wherein welding the tissue includes fusing the tissue acutely to at least partially seal the patent foramen ovale, and wherein the method further comprises allowing the patient's healing process to further seal the patent foramen ovale.  
     
     
         25 . The method of  claim 16 , the method comprising closing the patient's patent formamen ovale without piercing the primum or secundum tissues.  
     
     
         26 . A method for closing a patient's patent foramen ovale, comprising: 
 drawing at least one of the patient's primum and secundum tissues toward the other as to bring the tissues together, the primum and the secundum being portions of the patient's atrial septum;    applying energy to the primum and secundum; and    welding at least a portion of the primum and a portion of the secundum together to at least partially seal the patent foramen ovale.    
     
     
         27 . The method of  claim 26 , the method comprising closing the patient's patent formamen ovale without piercing the primum or secundum tissues.  
     
     
         28 . A method for closing a patient's patent foramen ovale, comprising: 
 applying a vacuum to the patient's atrial septum tissues as to bring the tissue together, the atrial septum including a primum and a secundum;    applying energy to the primum and secundum; and    welding at least a portion of the primum and a portion of the secundum together to at    least partially seal the patent foramen ovale    
     
     
         29 . The method of  claim 28 , the method comprising closing the patient's patent foramen ovale without piercing the patient's atrial septum tissues.