HIGH-POWER INTERSTITIAL ULTRASOUND LIVER TUMOR ABLATION

这项工作的目的是开发和评估高功率间质超声治疗器技术和支持系统，专门用于肝肿瘤的热消融。最近对前列腺和适度灌注组织中的间质超声施加器的研究表明，其加热模式非常可控和穿透，可以成形和动态改变，为适应性热手术提供了理想的机制。为了将该技术扩展到肝脏消融，提出了以下I期研究：（1）修改用于肝脏肿瘤消融所需的高功率设备的现有施加器技术;（2）执行新功率应用方案和消融肝脏肿瘤的特定设计参数的理论研究;（3）开发和集成用于控制系统原型的系统硬件和软件;和（4）进行体内肝脏实验以评估施用器和支持系统。与现有的射频、激光和微波技术相比，将评估在更短的时间范围内以更好的控制对横向和纵向较大肿瘤体积进行受控/适形治疗的可行性。从这些研究中获得的结果和经验将应用于肝肿瘤治疗的临床方法和程序的概念开发，并在随后的II期申请中提出实施。拟议的商业应用：肝肿瘤的微创热消融是一种临床上可行的技术，它提供了一种病态程度较低的手术替代方案，可应用于疾病不可手术切除或开放手术风险较低的患者。目前的技术仅限于有效治疗<3cm的球形肿瘤。高功率组织间超声技术具有显著的潜力，可以以可控和快速的方式治疗形状复杂的较大肿瘤，从而可以对更多病例进行更有效的治疗。

The objective of this proposed effort is to develop and evaluate high- powered interstitial ultrasound applicator technology and support systems specifically for thermal ablation of liver tumors. Recent investigations with interstitial ultrasound applicators in prostate and moderately perfused tissues have demonstrated extremely controllable and penetrating heating patterns which can be shaped and dynamically altered, providing an ideal mechanism for conformable thermal surgery. In order to extend this technology to liver ablation, the following Phase I studies are proposed: (1) modify existing applicator technology for high- power devices required for liver tumor ablation; (2) perform theoretical investigations of new power application schemes and design parameters specific to ablating liver tumors; (3) develop and integrate system hardware and software for a controlling system prototype; and (4) perform in vivo liver experiments to evaluate applicators and support systems. The feasibility of controlled/conformal treatment of transversely and longitudinally larger tumor volumes in shorter time frames and with greater control will be assessed as compared to existing RF, Laser, and Microwave technology. The results and experience obtained from these studies will be applied to the conceptual development of clinical approaches and procedures in the treatment of liver tumors, with proposed implementation in the succeeding Phase II application. PROPOSED COMMERCIAL APPLICATIONS: Minimally-invasive thermal ablation of liver tumors is a clinically viable technique which provides a less morbid alternative to surgery, and can be applied in patients whose disease is not surgically resectable or are a poor risk for open surgery. Current technology is limited to treating spherically shaped tumors <3cm effectively. High-power interstitial ultrasound technology has significant potential to treat larger tumors of complex shapes in controllable and faster manner, permitting more effective treatment for larger number of cases.