ULTRASONIC EPICARDIAL ABLATION FOR TREATING ATRIAL FIB.

描述（由申请人提供）： Spectrasonics Imaging与滨江研究所（RRI）和哥伦比亚长老会医院合作，提出了一项I期工作，旨在设计、采集和评价用于心外膜消融治疗房颤（AF）的线阵高强度聚焦超声（HIFU）换能器。换能器应具有HIFU和脉冲回波成像能力-后者用于监测消融期间的组织变化，从而控制消融过程。HIFU具有优于其他消融能量源（例如RF）的优势，因为能量可以聚焦以产生均匀的透壁损伤。长期目标是开发一种系统，该系统将安全有效地消融左心房，其模式将阻断引起AF的异常病灶的传导。初始患者人群将是接受心脏手术（如冠状动脉旁路移植术（CABG）和二尖瓣置换术（MVR））的AF患者。最终有可能通过胸腔镜进行手术，治疗更广泛的房颤人群。第1阶段计划将涉及确定频率、尺寸、焦点和强度要求，设计实用的换能器设计，然后对设计进行建模，以验证波束形状以及由此产生的组织温度和损伤。

DESCRIPTION (provided by applicant): Spectrasonics Imaging, in collaboration with Riverside Research Institute (RRI) and Columbia Presbyterian Hospital proposes a Phase I effort to design, acquire and evaluate a linear array high intensity focused ultrasound (HIFU) transducer for the application of epicardial ablation for treating atrial fibrillation (AF). The transducer is to have both HIFU and pulse echo imaging capability - the latter for monitoring tissue change during the ablation and thereby controlling the process. HIFU has advantages over other ablation energy sources (e.g. RF) because the energy can be focused to produce homogeneous transmural lesions. The long term objective is to develop a system that will safely and effectively ablate the left atrium in a pattern that will block conduction from aberrant foci causing AF. The initial patient population will be AF patients undergoing cardiac surgery such as coronary artery bypass grafts (CABG) and mitral valve replacement (MVR). Eventually it may be possible to conduct the procedure thoroscopically and treat a much wider AF population. The Phase 1 program will involve determining frequency, size, focal and intensity requirements, devising a practical transducer design, and then modeling the design to verify beam shape and the resulting tissue temperature and damage.