FrostBite - A Unique Catheter for Endoscopic Cryoablation

迫切需要设计新的设备，以促进范式改变的发展， 微创，原位治疗病变组织的方法。此外，还有一个不断增长的 许多研究表明，组合方法为个性化提供了一条途径， 治疗各种疾病的策略。同时提供了一条有前途的道路， 在医学上，个性化、微创、组合疗法的发展已经放缓 由于技术限制。因此，迫切需要新的医疗设备， 能够制定跨学科的战略来对抗疾病。第一阶段项目是 旨在通过开发一种新的柔性内窥镜兼容 设计用于治疗各种胃肠道相关组织疾病的导管， 应用多种治疗和诊断方法（药物、双消融、细胞和 基因治疗等）在一个单一的设备格式（FrostBite）。提供多功能- FrostBite导管的参数治疗方案通过其与先进的 成像方法包括内窥镜超声、MRI和CT。最初的研发活动产生了 在能够在10分钟内将双重热损伤递送到目标的原型1.5mm针尖导管中， 在不到2分钟的时间内产生约2.5 cm的破坏区。初步研究 药物/热损伤的组合在组织模型中也显示出改善的结果。根据本 我们打算开发和测试这种下一代内窥镜兼容导管， 评估一系列组合策略。该项目的成功完成将提供一个 能够开发和应用高级个性化治疗的新型医疗器械 为成千上万患有多种胃肠道组织疾病的患者提供治疗方案 用当今最先进的设备无法治疗或治疗不充分的状态。

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.