Catheter Based Cardiovascular Device Retrieval System

基于导管的心血管装置检索系统

• 批准号: 10010592
• 负责人: JOSEPH H GORMAN
• 金额: $ 127.03万
• 依托单位: ONOCOR, LLC
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-24 至 2022-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10010592
• 关键词: Animal Model; Aortic Aneurysm; Atrial Heart Septal Defects; Cardiovascular Diseases; Cardiovascular system; Catheters; Clinical; Clinical Research; Complex; Congenital Abnormality; Custom; Data; Development; Devices; Disease; Distal; Effectiveness; Encapsulated; Evaluation Reports; Family suidae; Femoral vein; Freezing; Goals; Guidelines; Heart; Hemostatic Agents; Human; Implant; Intuition; Marketing; Mechanics; Modeling; Molds; Operative Surgical Procedures; Pain; Patients; Phase; Procedures; Process; Radial; Recovery; Retrieval; Right atrial structure; Running; Small Business Technology Transfer Research; Stents; Sterilization; Structure; Surgical sutures; System; Technology; Testing; Training; Validation; Ventricular Septal Defects; Work; aortic valve; base; biomaterial compatibility; clinically relevant; design; experience; first-in-human; manufacturing process; nitinol; novel; performance tests; post-market; prototype; research clinical testing; safety net; surveillance data; tool

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

最近的技术进步使治疗越来越多的 结构性心血管疾病的导管为基础的程序。房间隔缺损（ASD）， 室间隔缺损（VSD）、主动脉瘤、先天性缺损和瓣膜疾病都是 目前正在使用基于导管的策略进行治疗。这些程序很复杂， 即使是经验丰富的操作员也容易发生器械错位。目前正在接受外科治疗 需要程序来取回错放的设备。经导管回收系统将 这是一项重大的进步，它将使病人免除外科手术治疗的痛苦。 并提供一个“安全网”，促进这些侵入性较小的程序的使用， 从中受益的患者数量。Onocor已经开始开发这种检索 系统Onocor系统包括：（1）用于导入 系统和目标植入物的回收，（2）一种新型镍钛合金丝编织篮， 包封、压缩和回收目标植入物，（3）机械优势系统， 稳定地施加撤回力和（4）操纵工具以帮助定向目标 植入 在第一阶段进行的初步工作中，我们证明了 压缩大型支架（主动脉瓣支架、主动脉瘤支架）的网篮。的疗效 在移除许多类型的错位的心血管装置中的取回系统也已经 在动物模型中得到广泛证实。当前第二阶段STTR提案的目标是 是将设计概念细化到首次应用于人体的程度