Cooled Laser Delivery System: Improved Thermal Therapy

描述（由申请人提供）：本研究的重点是继续开发一种新的间隙冷却激光传输系统，用于改进热治疗。该系统的目的是在癌症肿瘤的热破坏中找到应用。激光间质热疗法（LITT）是一种理想的微创治疗局部肿瘤的方法，但由于目前间质应用器的局限性，迄今未能获得广泛的临床接受。在第一阶段，我们设计、制造并测试了一种新型的冷却激光光纤（CLF）输送设备，该设备包括一个先进的集成扩散尖端光纤，以及一种改进的方法，可以从靠近敷料器的光纤和组织中去除热量。我们在体外和体内对该系统进行了表征，并证明该系统在安全可靠的方式下优于非冷却涂抹器，可以产生更大的激光病变。

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.