Cooled Laser Delivery System: Improved Thermal Therapy

冷却激光传输系统：改进的热疗法

• 批准号: 6935655
• 负责人: Ashok Gowda
• 金额: $ 38.59万
• 依托单位: BIOTEX, INC.
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-01 至 2007-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6935655
• 关键词: bioimaging /biomedical imaging; biomedical equipment development; clinical biomedical equipment; cold temperature; disease /disorder model; dogs; fiber optics; histopathology; image guided surgery /therapy; laser therapy; liver; neoplasm /cancer radiation therapy; nonhuman therapy evaluation; phantom model; photocoagulation therapy; therapy design /development

DESCRIPTION (provided by applicant): The focus of this research is to continue development of a novel interstitial cooled laser delivery system for improved thermal therapy. The system is intended to find applications in the thermal destruction of cancerous tumors. Laser interstitial thermal therapy (LITT) is an ideal method for minimally invasive treatment of localized tumors, but has so far failed to gain widespread clinical acceptance due to limitations of current interstitial applicators. In Phase I, we designed, built, and tested a novel cooled laser fiber (CLF) delivery apparatus which includes an advanced integrated diffusing tip fiber optic along with an improved means for heat removal from both the fiber optic and tissue in close proximity to the applicator. We characterized the system in vitro and in vivo and demonstrated that the system was superior to non-cooled applicators for creating larger laser lesions in a safe and reliable manner. In Phase II we will extend our initial development efforts and refine the CLF device by optimizing materials, expanding size configurations, improving construction methods, and investigating optimal cooling parameters. In addition, we plan to add features to the device that will allow rotation and translation of the internal fiber optic delivery element for asymmetric lesion production. Finally we will fully characterize the complete system in primary target tissues by examining lesion sizes resulting from various laser powers, wavelengths, cooling rates, and exposure durations. A major goal throughout this work will be to acquire sufficient data necessary for completion and submission of a 510(k) application with the FDA.

描述（由申请人提供）：本研究的重点是继续开发一种新型间质冷却激光传输系统，以改善热治疗。 该系统旨在应用于癌性肿瘤的热破坏。 激光间质热疗（LITT）是一种理想的微创治疗局部肿瘤的方法，但迄今为止，由于目前的间质施源器的限制，未能获得广泛的临床接受。 在第一阶段中，我们设计、构建并测试了一种新型冷却激光光纤（CLF）输送装置，该装置包括一个先进的集成扩散尖端光纤沿着，并具有一种改进的装置，用于从光纤和靠近施加器的组织中去除热量。 我们在体外和体内对该系统进行了表征，并证明该系统上级非冷却式施源器，可以安全可靠地创建更大的激光损伤。 在第二阶段，我们将扩大我们的初步开发工作，并通过优化材料，扩大尺寸配置，改进施工方法和研究最佳冷却参数来完善CLF设备。 此外，我们计划在器械中增加允许内部光纤输送元件旋转和平移的功能，以产生不对称损伤。 最后，我们将通过检查各种激光功率、波长、冷却速率和暴露持续时间导致的损伤尺寸，全面表征主要靶组织中的完整系统。 这项工作的一个主要目标是获得完成并向FDA提交510（k）申请所需的足够数据。