HIGH-POWER INTERSTITIAL ULTRASOUND LIVER TUMOR ABLATION

这项拟议工作的目标是开发和评估专门用于肝肿瘤热消融的高功率组织间超声应用技术和支持系统。最近对前列腺和中等灌流组织中的间质超声辐射器的研究表明，加热模式非常可控和穿透，可以成形和动态改变，为顺应性热手术提供了理想的机制。为了将这项技术扩展到肝脏消融，建议进行以下第一阶段研究：(1)修改现有的用于肝脏肿瘤消融所需的大功率设备的应用技术；(2)对新的功率应用方案和特定于消融肝肿瘤的设计参数进行理论研究；(3)为控制系统原型开发和集成系统硬件和软件；以及(4)进行活体肝脏实验，以评估应用程序和支持系统。与现有的射频、激光和微波技术相比，将评估在更短的时间内和更好的控制下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治疗肝脏肿瘤的临床方法和程序的概念发展，并建议在随后的第二阶段应用中实施。拟议的商业应用：肝肿瘤的微创热消融是一种临床可行的技术，它提供了一种比手术发病率更低的选择，可以应用于疾病不能通过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3厘米的球形肿瘤。高功率间质超声技术在以可控和快速的方式治疗较大的复杂形状的肿瘤方面具有巨大的潜力，使更多的病例能够更有效地治疗。

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.