Preshaped ablation catheter for ablating pulmonary vein ostia within the heart

Abstract

Catheters and methods are provided for performing medical procedures. The catheter comprises an elongated flexible integrated catheter body having proximal and distal shaft portions, a central support positioned inside the distal shaft and at least one operative element carried by the distal shaft portion. The distal shaft portion has a proximal section configured to be internally actuated to form a simple curve with an apex that can be inserted into the vessel ostium, an intermediate section pre-shaped to form a curve that bends opposite the simple curve, and a distal section configured to be placed into a non-radial relationship with the vessel ostium when the apex of the simple curve is inserted into the vessel ostium.

We claim: 
     
         1 . A catheter, comprising:
 an elongated flexible integrated catheter body including:
 a proximal shaft portion having a longitudinal axis, 
 a distal shaft portion having a proximal section configured to be internally actuated to form a simple curve, an intermediate section pre-shaped to form a complex curve, and a distal section, wherein the simple curve lies in a single plane and the complex curve bends the intermediate section opposite to and out-of-plane with the simple curve; 
 a center support positioned inside the distal shaft and passing through at least a portion of the distal shaft; and 
 at least one operative element carried by the distal section. 
   
     
     
         2 . The catheter of  claim 1 , wherein the center support is formed of a resilient inert wire or a resilient injection molded plastic. 
     
     
         3 . The catheter of  claim 2 , wherein the resilient inert wire is formed of a resilient inert wire, the resilient inert wire being comprised of at least one of the following: nickel titanium and 17-7 stainless steel wire. 
     
     
         4 . The catheter of  claim 1 , wherein the center support extends the length of the distal shaft. 
     
     
         5 . The catheter of  claim 1 , wherein at least a portion of the center support has a rectangular cross section. 
     
     
         6 . The catheter of  claim 1 , wherein at least a portion of the center support has a circular cross section. 
     
     
         7 . The catheter of  claim 6 , wherein a diameter of the center support is between 0.30 mm and 0.85 mm. 
     
     
         8 . The catheter of  claim 1 , wherein the center support is comprised of two center supports joined together. 
     
     
         9 . The catheter of  claim 1 , wherein a proximal portion of the center support extends into the proximal shaft and the proximal portion of the center support is affixed to a distal portion of the proximal shaft. 
     
     
         10 . The catheter of  claim 9 , wherein the proximal portion of the center support is soldered to the distal portion of the proximal shaft. 
     
     
         11 . The catheter of  claim 1 , further comprising a filler material disposed between the center support and the distal shaft portion. 
     
     
         12 . The catheter of  claim 11 , wherein the filler material is an epoxy. 
     
     
         13 . A method of performing a medical procedure adjacent an ostium of a vessel using the catheter of  claim 1 , comprising:
 inserting an apex of the simple curve into the vessel ostium to place the at least one operative element in contact with a first tissue site adjacent the vessel ostium; and   performing the medical procedure on the first tissue site with the at least one operative element.   
     
     
         14 . The method of  claim 13 , further comprising:
 rotating the simple curve within the vessel ostium about the apex to place the operative element in contact with a second tissue site adjacent the vessel ostium; and   performing the medical procedure on the second tissue site with the at least one operative element.   
     
     
         15 . The method of  claim 13 , wherein the at least one operative element comprises an ablative element, and performing the medical procedure comprises forming a lesion at the first tissue site with the ablative element. 
     
     
         16 . A catheter, comprising:
 an elongated flexible integrated catheter body including:
 a proximal shaft portion having a longitudinal axis, 
 a distal shaft portion having a proximal section configured to be internally actuated to form a simple curve with an apex that can be inserted into an ostium of an anatomical vessel, an intermediate section pre-shaped to form a complex curve including a proximal curve and a distal curve, and a distal section, wherein the proximal curve is configured to place the distal section in contact with tissue outside of the vessel ostium, and the distal curve is configured to place the distal section into a non-radial relationship with the vessel ostium merely by the insertion of the apex of the simple curve into the vessel ostium; 
 a center support positioned inside the distal shaft and passing through at least a portion of the distal shaft; and 
 at least one operative element carried by the distal section, and configured to be placed firmly in contact with tissue adjacent the vessel ostium when the apex of the simple curve is inserted into the vessel ostium. 
   
     
     
         17 . The catheter of  claim 16 , wherein the center support is formed of a resilient inert wire or a resilient injection molded plastic. 
     
     
         18 . The catheter of  claim 16 , wherein the resilient inert wire is formed of a resilient inert wire, the resilient inert wire being comprised of at least one of the following: nickel titanium and 17-7 stainless steel wire. 
     
     
         19 . The catheter of  claim 16 , wherein at least a portion of the center support has a rectangular cross section. 
     
     
         20 . The catheter of  claim 16 , wherein at least a portion of the center support has a circular cross section.