Catheter system for the treatment of atrial fibrillation

A method for the treatment of atrial fibrillation, the method including the following steps:

• a) an introducer sheath is placed into the left or right femoral vein,
• b) a guide wire is advanced through the femoral vein, through the inferior vena cava and then into the right atrium,
• c) using standard trans-septal puncture technique, a guide wire is placed across the interatrial septum from the right into the left atrium,
• d) further dilatation of the interatrial septum puncture site is able to be performed with a balloon angioplasty catheter, if necessary,
• e) appropriate anticoagulation is given to minimize the risk of left atrial thrombus during the rest of the manipulations,
• f) a special purpose guiding catheter including a dilator is advanced over the guide wire and through the inferior vena cava and into the right atrium,
• g) the dilator and guiding catheter are then pushed through the interatrial septum from the right atrium into the left atrium, using the guide wire already placed in the left atrium,
• h) the dilator is removed,
• i) a specially designed two-balloon catheter is then advanced over the guide wire and through the guiding catheter until its distal end is situated in the left atrium,
• j) the guide wire and/or the guiding catheter are manipulated until the guide wire is placed into the first targeted pulmonary vein,
• k) the guidance of the guide wire and the balloon ablation catheter into each of the targeted pulmonary veins (up to four) is guided by intra-cardiac or trans-esophageal ultrasound imaging, or other real-time imaging modalities,
• l) the tapered balloon and the toroidal balloon are then advanced until the proximal portion of the tapered balloon is situated just proximal to the ostium of that pulmonary vein,
• m) the tapered balloon and the toroidal balloon are then inflated to a pressure such that the proximal portion of the tapered balloon just fits within the ostial region of the pulmonary vein,
• n) the balloons are then pushed forward until the distal surface of the toroidal balloon is in contact with, and applies some pressure onto, the endocardial surface of the left atrium surrounding the ostium of the pulmonary vein,
• o) ablation of the tissue of the left atrium surrounding the ostium of the pulmonary vein is then applied by any well known method such as the use of rf energy, cryogenic cooling or heating with a high temperature fluid or heated electrical wire,
• p) the application of the ablative means is then discontinued and the balloons are deflated,
• q) if it is desired to ablate the region of the left atrium near the ostium of a second, third or fourth pulmonary vein, then the steps 10-16 above are repeated for each region where it is desired to perform tissue ablation of the left atrium, and
• r) when treatment of the last region of the left atrium that is to be ablated is completed, all the apparatus used (viz., the guide wire, two-balloon catheter, guiding catheter and introducer sheath, etc.) are then removed from the patient's body.