Catheter Based Cardiovascular Device Retrieval System

在过去十年中，在数量、范围和 结构性心脏病导管介入治疗的复杂性。经导管主动脉 瓣膜置换术（TAVR）、动脉瘤腔内修复术（EVAR）、腔静脉滤器和 心内缺损闭合都是发展良好且不断发展治疗策略。近期 FDA批准左心耳（LAA）封堵术治疗房颤和未闭孔 卵圆（PFO）闭合治疗隐源性卒中，为大量应用打开了大门 这些程序。这一趋势显示出加速的迹象， 包括经导管二尖瓣置换术（TMVR）器械在内的各种选择即将出现。 目前需要补救性外科手术来取回错位的装置。一 经导管回收系统将代表一个重大进步， 疼痛的补救外科手术，并提供一个“安全网”，促进使用这些 减少侵入性手术，并扩大从中受益的患者数量。我们集团 已经开始开发这样的检索系统。该系统包括（1）定制的共同， 用于导入系统和回收目标植入物的轴向导管，（2）新型镍钛合金 金属丝编织篮，设计用于包裹、压缩和回收目标植入物，（3） 用于稳定施加撤回力的机械利益系统和（4）操纵 用于辅助定向目标植入物的工具。 在初步工作中，我们已经证明了篮子在压缩 大型支架（主动脉瓣支架、主动脉瘤支架）。早期引入的可行性 在动物模型中也显示了将原型植入心脏并将其取出的方法。以来 上一次提交该申请时，对初始原型的研究发现了以下方面的弱点： 这一设计得到了很大的改进。当前第一阶段STTR的目标是 建议是加强现有的原理数据证明，并证明进一步优化的合理性 Onocor检索系统的设计和实现。

During the past decade there has been an exponential growth in the number, scope and complexity of catheter-based interventions for structural heart disease. Transcatheter aortic valve replacement (TAVR), endovascular aneurysm repair (EVAR), vena caval filters and intracardiac defect closure are all well developed and growing treatment strategies. The recent FDA approval of left atrial appendage (LAA) occlusion for atrial fibrillation and patent foramen ovale (PFO) closure for cryptogenic stroke, has opened the door for the high volume application of these procedures. The trend shows signs of acceleration with ever more complex therapeutic options on the horizon including devices for transcatheter mitral replacement (TMVR). Currently remedial surgical procedures are required to retrieve misplaced devices. A transcatheter retrieval system would represent a major advance that would spare patients the pain of remedial surgical procedures and provide a “safety net” that promotes the use of these less invasive procedures and expands the number of patients who benefit from them. Our group has begun development of such retrieval system. The system consists of (1) customized co- axial catheter for introduction of the system and recovery of the target implant, (2) a novel nitinol wire woven basket designed to envelope, compress and retrieve the target implant, (3) mechanical advantage system for steady application of the withdraw force and (4) manipulation tools to aid in orienting the target implant. In preliminary work we have demonstrated the effectiveness of the basket in compressing large stents (aortic valve frames, aortic aneurysm stents). The feasibility of introducing early prototypes into the heart and withdrawing them in animal models has also been shown. Since the last submission of this application, studies of initial prototypes have identified weakness in the design which have been improved significantly. The goal of the current Phase I STTR proposal is to strengthen the existing proof of principle data and justify the further optimization of the design and implementation of the Onocor Retrieval system.