FrostBite - A Unique Catheter for Endoscopic Cryoablation

迫切需要设计促进范式改变的开发的新设备， 微创，就地治疗病变组织的方法。此外，还有一个不断增长的 大量研究表明，组合方法正在为个性化提供一条途径 治疗多种疾病状态的策略。同时提供了一条有希望的革命性道路 医学，个性化、微创、组合疗法的发展已经放缓 由于技术上的限制。因此，迫切需要新的医疗设备来 能够制定与疾病作斗争的跨学科战略。这个第一阶段的项目是 旨在通过开发一种新的灵活的内窥镜兼容来满足这一需求 专为治疗各种胃肠道相关组织疾病而设计的导管 应用多种治疗和诊断方法(药物、双重消融、细胞和 基因疗法等)采用单一设备形式(冻伤)。能够提供多个 冻伤导管的参数治疗方案因其与先进技术的兼容性而得到改进 成像方法包括内窥镜超声、核磁共振和CT。最初的研发活动产生了 在1.5 mm针尖导管原型中，能够将双重热绝缘传递到10 在不到2分钟的时间内形成了一个约2.5厘米的破坏区。对…的初步研究 在组织模型中，联合药物/热绝缘也显示出改善的结果。在这下面 我们打算开发和测试这种下一代内窥镜兼容导管以及 评估一系列组合策略。该项目的成功完成将为 能够开发和应用先进个性化治疗的新型医疗设备 上千例胃肠道组织性疾病患者S百日治法 使用当今最先进的设备无法治疗或治疗不足的州。

There is a pressing need for designing new devices facilitating the development of paradigm changing, minimally invasive, approaches to treat diseased tissues in situ. Additionally, there is a growing number of studies showing 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 new medical devices to enable the development of trans-disciplinary strategies to combat disease. This Phase 1 project is designed to address this need through the development of a new flexible endoscopic compatible catheter designed for the treatment of various gastrointestinal related tissue diseases enabling the application of multiple therapeutic and diagnostic approaches (pharmaceutical, dual-ablation, cell and gene therapy, among others) in a single device format (FrostBite). The ability to deliver multi- parametric treatment regimes of the FrostBite catheter is enhanced by its compatibility with advanced imaging approaches including endoscopic ultrasound, MRI, and CT. Initial R&D activities have resulted in a prototype 1.5mm needle tip catheter capable of delivering dual thermal insults to a target within 10 seconds creating a zone of destruction of ~2.5cm in less than 2 mins. Preliminary studies into combinatorial drug/thermal insults have shown improved outcomes in tissue models as well. Under this proposal we intend to develop and test this next generation endoscopic compatible catheter as well as evaluate a series of combinatorial strategies. 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.