MRI catheter design and fabrication

National Heart, Lung, And Blood Institute

Investigators

Linked publications, trials & patents

Abstract

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. This has required further design and testing iteration to assure human safety. We have invented a novel segmented vascular guidewire that promises to overcome many of the safety and mechanical shortcomings of previous devices, and expect to be able to enter into clinical testing in the near future. We were awarded a collaborative grant with Georgia Institute of Technology to develop a full-volume three-dimensional ultrasound probe, using CMUT on CMOS technology, that can also operate inside MRI. Early prototypes have been tested under MRI for this leapfrog technology. We collaborate with Bogazici University to develop new manufacturing techniques for microminiature electronics to enable safe and conspicuous MRI devices, especially a needle antenna for human application. We have invented several first-in-class interventional devices for novel therapeutic non-surgical procedures. These include devices for trans-atrial catheter-based tricuspid valve repair, transcaval access to the aorta to enable transcatheter aortic valve replacement in patients with no good options, non-surgical access to the left atrium, novel vascular introducer sheaths, and extra-anatomic bypass for congenital heart disease without surgery. Many of these include inventions and patent applications for novel medical devices, such as purpose-built closure devices for transcaval access to the aorta. We also work with industry to translate our laboratory inventions into the private sector for patient care. We have entered into collaborative research and development agreements with a large catheter company, research agreements with small catheter company to co-develop some devices. We also have sponsored Small Business Innovation Research contracts from our intramural laboratory to shepherd novel high-risk technology through small businesses into clinical testing. We have worked closely with 480 Biomedical, through a NHLBI SBIR contract, to support clinical development and testing of a novel device, a bioabsorbable stent, into the field of pediatric cardiology, where there is an enormous unmet need but little industry support for early clinical funding.