MRI catheter design and fabrication

MRI 导管设计和制造

• 批准号: 8746879
• 负责人: Robert J Lederman
• 金额: $ 79.84万
• 依托单位: NATIONAL HEART, LUNG, AND BLOOD INSTITUTE
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/8746879
• 关键词: Anatomy; Animal Testing; Bypass; Catheters; Chronic; Clinical; Devices; Frequencies; Goals; Heart Diseases; Heating; Human; Imaging Device; Imaging Techniques; Implant; Magnetic Resonance Imaging; Mitral Valve Insufficiency; National Heart, Lung, and Blood Institute; Procedures; Protocols documentation; Radio; Safety; Shunt Device; Testing; Time; Tricuspid valve structure; Ventricular Septal Defects; Work; base; congenital heart disorder; design; good laboratory practice; improved; nitinol; novel; operation; programs; prototype; repaired; safety testing

During the past year we have continued our work developing magnetic resonance imaging (MRI) compatible and visible devices to perform endoluminal interventional procedures that are planned to perform under MRI. We have nearly completed a human-grade MRI guidewire that provides both tip and shaft visibility and provides assurance of safety during operation. We have developed a rigorous Good Laboratory Practice animal testing program. We have prepared a regulatory submission to allow first-in-human testing in the upcoming year. We continue to work on radio frequency heating safety tests of interventional MRI devices. We currently work on to develop a new general protocols to test heating safety of active intravascular devices during real time MRI procedures We continue to develop novel prototypes of catheters and implants to treat valvular and congenital heart disease. We have invented several new devices, including for catheter-based tricuspid valve repair, caval-aortic access, and large sheath access.

在过去的一年里，我们继续开发磁共振成像 (MRI) 兼容的可见设备，以执行计划在 MRI 下执行的腔内介入手术。 我们即将完成人类级 MRI 导丝，该导丝可提供尖端和轴的可见性，并保证操作过程中的安全。 我们制定了严格的良好实验室规范动物测试计划。 我们已经准备了一份监管申请，以允许在来年进行首次人体测试。 我们继续致力于介入MRI设备的射频加热安全测试。我们目前致力于开发新的通用协议，以测试实时 MRI 过程中主动血管内装置的加热安全性 我们继续开发新型导管和植入物原型来治疗瓣膜和先天性心脏病。 我们发明了几种新设备，包括用于基于导管的三尖瓣修复、腔静脉主动脉通路和大鞘通路。