Abstract: The purpose of this study was to investigate performance characteristics of a catheter-based ultrasound applicator intended for circumferential ablation of cardiac tissue. The catheter design integrates a cylindrical ultrasound transducer within a distendable water filled balloon in order to produce circumferential lesions at sites in the atria (i.e., pulmonary vein ostia), intended for treatment of certain atrial arrhythmias. Biothermal simulations were used to investigate thermal lesion depths corresponding to variations in applied power, duration, balloon diameter, and acoustic efficiency. Prototype applicators of varying frequency (7 - 12 MHz) and balloon diameter were constructed and characterized using measurements of acoustic efficiency and rotational beam plots. In vitro studies were performed in freshly excised beef hearts to characterize the radial penetration, axial length, and angular uniformity of thermal lesions produced by these applicators. Selected applicators were tested in vivo within pulmonary veins, coronary sinus, and atrial appendage of canine and porcine hearts. These preliminary efforts have indicated that circumferential ablation of cardiac tissue using ultrasound balloon catheters is feasible, and devices between 7 - 12 MHz with balloon diameters of 1.5 - 2.0 cm are capable of producing uniform lesions between 1 - 5 mm depth or greater for treatment durations of 120 seconds or less.!20
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