Catheter Based Cardiovascular Device Retrieval System

最近的技术进步使治疗越来越多的 通过基于导管的手术治疗结构性心血管疾病。房间隔缺损(ASD)， 室间隔缺损(VSD)、主动脉瘤、先天性缺陷和瓣膜疾病都是 目前正在使用基于导管的策略进行治疗。这些程序很复杂，而且 即使是有经验的操作员，也容易出现设备错位的情况。目前正在进行补救性手术 要找回放错位置的设备，需要执行程序。一种经导管检索系统将 代表着一项重大进步，将使患者省去治疗性外科手术的痛苦 并提供一个“安全网”，促进这些侵入性较小的手术的使用，并扩大 从这些措施中受益的患者数量。Onocor已经开始开发这种检索 系统。Onocor系统包括(1)定制的同轴导管，用于引入 靶种植体的系统和回收，(2)一种新型的镍钛金属丝编织篮，设计用于 包络、压迫和回收靶向种植体；(3)机械优势系统 稳定地应用退出力和(4)辅助定向目标的操作工具 植入。 在第一阶段进行的初步工作中，我们已经证明了 在加压大型支架(主动脉瓣膜支架、主动脉瘤支架)中使用篮子。的功效。 取出许多类型错位的心血管装置的取回系统也被 在动物模型中得到广泛证明。当前第二阶段STTR提案的目标是 是将设计概念细化到第一个人的应用程序

Recent advances in technology have made possible the treatment of a growing number of structural cardiovascular diseases by catheter based procedures. Atrial septal defects (ASD), ventricular septal defects (VSD), aortic aneurysm, congenital defects and valve disease are all currently being treated with catheter based strategies. These procedures are complex and are prone to device misplacement, even by experienced operators. 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. Onocor has begun development of such retrieval system. The Onocor 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, carried out in Phase I, we have demonstrated the effectiveness of the basket in compressing large stents (aortic valve frames, aortic aneurysm stents). The efficacy of the retrieval system in removing many types of misplaced cardiovascular devices has also been extensively demonstrated in animal models. The goal of the current Phase II STTR proposal is to refine the design concept to the point of first-in-man applications