MRI-safe 3Dl intracardiac ultrasound catheter for cardiovascular intervention

用于心血管介入的 MRI 安全 3Dl 心内超声导管

• 批准号: 8639877
• 负责人: F. Levent Degertekin
• 金额: $ 68.33万
• 依托单位: GEORGIA INSTITUTE OF TECHNOLOGY
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-02-07 至 2017-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8639877
• 关键词: 3-Dimensional; Address; Adult; Affect; Animal Model; Animals; Architecture; Atrial Heart Septal Defects; Beryllium; Biological; Caliber; Cardiac; Cardiomyopathies; Cardiovascular system; Catheterization; Catheters; Child; Childhood; Clinical; Clinical Trials; Code; Collaborations; Complex; Custom; Data; Denmark; Development; Devices; Diagnostic radiologic examination; Disease; Doctor of Philosophy; Effectiveness; Electronics; Engineering; Exposure to; Face; Frequencies; Future; Goals; Heart; Heart Diseases; Human; Image; In Vitro; Institution; Intervention; Left; Magnetic Resonance Imaging; Microfabrication; Miniaturization; National Heart, Lung, and Blood Institute; Operative Surgical Procedures; Outcome; Pathology; Patients; Performance; Phase; Phase I Clinical Trials; Population; Preclinical Testing; Procedures; Process; Radiation; Resources; Roentgen Rays; Route; Safety; Sampling; Scheme; Silicon; Structure; Symptoms; System; Systems Development; Technology; Testing; Time; Translating; Ultrasonography; United States National Institutes of Health; Universities; Ventricular Septal Defects; Work; auricular appendage; base; clinical application; design; image guided intervention; image processing; improved; in vitro testing; in vivo; microsystems; novel; operation; pre-clinical; preclinical evaluation; prototype; public health relevance; repaired; research clinical testing; software development; success; transmission process; valve replacement

DESCRIPTION (provided by applicant): Symptomatic adult and pediatric structural heart disease affects more than 2.9% of the US population, not including cardiomyopathies and rhythm disorders. Although nonsurgical approach is the preferred route for relief of symptoms, even common procedures such as atrial septal defect closure can be difficult, protracted, or unsuccessful because of limitations not only in available catheter devices but also because of inadequate image guidance. Current 2D and limited-volume 3D intracardiac ultrasound catheters do not provide suitable full-volume en face images to depict complex cardiac structures in real time, do not depict real-time navigation of catheters, and require adjunctive X-ray guidance. Miniaturization of ultrasound probes to provide uninterrupted real-time full-volume intra-procedural 3-dimensional en-face depiction of cardiac pathology and catheter devices would represent a dramatic advance in image-guided intervention. Further, design of a 3D ICE probe from inception to operate safely during MRI as well as during conventional X-ray would dramatically advance or even revolutionize the capabilities of transcatheter therapy by enabling completely radiation-free non-surgical catheter navigation. Our proposal aims to realize such a catheter, the 3D MRICE, based on the close collaboration of two groups at NHLBI and at Georgia Tech, and the unique resources available at the NIH Clinical Center for catheter fabrication, preclinical evaluation, and clinical trials. We use CMUT-on-CMOS technology and massive parallel RF data multiplexing to implement an ultra- miniature, single chip volumetric ultrasound imaging system while reducing the transmission line count by 50x compared with current technology. Implemented as a novel actively cooled catheter of MRI-compatible materials, our approach will produce a versatile intravascular 3D ICE catheter that can operate under conventional X-ray and MRI. The 3D MRICE and custom, GPU based real-time imaging system will be evaluated systematically through in-vitro and in-vivo studies with special emphasis on MRI safety leading to a an Phase I IDE clinical trial at the end of year 3. If successful, our work will address a key unmet need and fundamentally enhance image-guided catheter treatments of complex heart disease to improve effectiveness and outcome.

描述（由申请人提供）：有症状的成人和小儿结构性心脏病会影响超过2.9％的美国人群，而不包括心肌病和节奏疾病。尽管非手术方法是缓解症状的首选途径，但即使是常见的程序，例如房间隔缺陷闭合也可能很困难，持久或不成功，因为不仅在可用的导管设备中，而且由于图像不足的指导而受到限制。当前的2D和限量体积3D心脏内部超声导管不提供合适的全批量的面部图像来实时描绘复杂的心脏结构，不要描述导管的实时导航，并且需要辅助X射线指导。超声探针的微型化，以提供不间断的实时全卷内部核内3维的心脏病理和导管设备的描述，将代表图像引导的干预措施的巨大进步。此外，从成立开始以及在MRI和传统X射线期间安全运行的3D ICE探针的设计将通过启用完全无辐射的非外科导管导航，从而极大地提高甚至彻底改变了经导管治疗的能力。我们的建议旨在根据NHLBI和Georgia Tech的两个小组的密切合作以及在NIH NIH导管临床制造，急诊评估和临床试验中获得的独特资源，以实现这种导管3D MRICE。我们使用CMUT-CMOS技术和大量的并行RF数据多路复用来实现超微型，单芯片体积超声成像系统，同时与当前技术相比，传输线数减少了50倍。我们的方法是作为一种新型的MRI兼容材料的活跃冷却的导管，我们的方法将产生一种多功能的血管内3D冰导管，该导管可以在常规的X射线和MRI下运行。 3D MRICE和习俗，基于GPU的实时成像系统将通过视野内和体内研究进行系统评估，并特别强调MRI安全性，从而在3年底进行I阶段IDE临床试验。如果成功。 ，我们的工作将满足未满足的关键需求，并从根本上增强了复杂心脏病的图像引导的导管治疗，以提高有效性和结果。