FrostBite - A Unique Catheter for Endoscopic Cryoablation

越来越多的研究表明，组合方法正在为 个性化的策略，以治疗各种疾病状态。同时提供了一条有希望的道路， 革命性的医学，个性化，微创，组合疗法的发展， 由于技术的限制，它的速度已经放慢。因此，迫切需要设计 新的设备，以促进发展的范式变化，微创，方法， 原位治疗病变组织，从而实现跨学科策略来对抗疾病。这个阶段 第二阶段项目是在第一阶段成功的基础上进行的，旨在满足这一需求 通过开发下一代柔性内窥镜兼容消融导管平台 （FrostBite）用于治疗各种胃肠道癌症，包括胰腺癌和肝癌。 该多功能平台将实现多种治疗和诊断应用， 方法（药物，消融等）在一个单一的设备格式，当组合 与新的维生素D3类似物，旨在增加冷冻的致死率，将提供一个 为多种癌症提供更好的治疗选择。提供多参数治疗的能力 FrostBite导管的治疗方案通过引入一种新型的可展开的 热传感器以真实的时间监测消融区域的形成。当它与先进的 成像方法的兼容性，包括内窥镜超声、MRI和CT，将提供 在手术过程中实现无与伦比的控制和可视化。第1阶段活动产生了1.27 mm原型 针尖导管能够在10秒内将冷冻损伤输送到目标， 在不到3分钟内破坏约2.5cm的区域。对药物/热损伤组合的研究还 在组织模型中表现出改善的结果。第2阶段旨在1）验证和测试 下一代内窥镜兼容冷冻导管，2）集成了一种新型原位可展开 - 多点热传感器，以使得能够真实的实时监测目标的热分布， 消融，3）开发和评估一系列维生素D3类似物（商业和新型），并测试 在离体工程肿瘤模型和体内工程肿瘤模型中的最佳组合装置和类似物方案 问题研究该项目建立在成功的P1研究以及其他研究的基础上， 来自CPSI、渥太华大学、宾厄姆顿大学和约翰霍普金斯大学的研究人员的专业知识 医学院开发一种新的手术器械和预防性药物组合方法， 更有效地治疗肝癌和胰腺癌。一旦完成，该项目将提供 一个有效的，微创治疗选择的个人患有这些和其他 基于胃肠的癌症，如结肠直肠癌、胃癌和食道癌。成功 该项目的完成将提供一种新型医疗器械， 应用先进的个性化治疗方案， 从许多胃肠道组织疾病状态，这些疾病状态是不可治疗的或治疗不充分的， 当今最先进的器械可提高患者的生存率和生活质量。

A growing number of studies have demonstrated that combinatorial approaches are providing a path for personalization of strategies to treat a wide array of disease states. While providing a promising path to revolutionize medicine, the evolution of personalized, minimally invasive, combinatorial therapies has been slowed as a result of technological limitations. As such, there is a pressing need for designing new devices to facilitate the development of paradigm changing, minimally invasive, approaches to treat diseased tissues in situ which enable trans-disciplinary strategies to combat disease. This Phase 2 project, which builds upon the success of the completed Phase 1, is designed to address this need through the development of a next generation flexible endoscopic compatible ablation catheter platform (FrostBite) for the treatment of various gastrointestinal cancers including pancreatic and liver cancer. This multi-functional platform will enable the application of multiple therapeutic and diagnostic approaches (pharmaceutical, ablation, among others) in a single device format which when combined with novel vitamin D3 analogs designed to increase the lethality of freezing, will provide for an enhanced treatment option for numerous cancers. The ability to deliver multi-parametric treatment regimens of the FrostBite catheter is enhanced by the incorporation of a novel deployable thermosensor to monitor ablation zone formation in real time. This, when combined with advanced imaging approach compatibility, including endoscopic ultrasound, MRI, and CT, will provide for unmatched control and visualization during a procedure. Phase 1 activities yielded a prototype 1.27mm needle tip catheter capable of delivering cryothermal insults to a target within 10 seconds creating a zone of destruction of ~2.5cm in less than 3 mins. Studies into combinatorial drug/thermal insults also demonstrated improved outcomes in tissue models. This Phase 2 is designed to 1) miniaturize and test the next generation endoscopic compatible cryocatheter, 2) integrate a novel in situ deployable multipoint thermal sensor to enable real time monitoring of the thermal profile of the target during ablation, 3) develop and evaluate a series of vitamin D3 analogs (commercial and novel), and test the optimal combination device and analog protocol in an ex vivo engineered tumor model and in in vivo studies. This project builds upon successful P1 studies, as well as others, and leverages the combined expertise of researchers from CPSI, University of Ottawa, Binghamton University, and Johns Hopkins School of Medicine to develop a new surgical device and adjunctive drug combination approach to more effectively treat cancers of the liver and pancreas. Once completed, this project will provide for an effective, minimally invasive treatment option for individuals suffering from these and other gastroenterological based cancers such as colorectal, stomach and esophageal cancer. Successful completion of this project will provide for a novel medical device enabling the development and application of advanced personalized treatment regimes for 100’s of thousands of patients who suffer from numerous gastrointestinal tissue disease states which are untreatable or inadequately treated with today’s state of the art devices yielding improved patient survival and quality of life.