MagPAD: Magnetic Puncture, Access, and Delivery of Large Bore Devices to the Heart Via the Venous System

MagPAD：通过静脉系统对大口径装置进行磁穿刺、进入和输送至心脏

• 批准号: 10600737
• 负责人: Mark Doherty
• 金额: $ 30.84万
• 依托单位: MAGPAD, LLC
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-03-01 至 2025-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10600737
• 关键词: 3-Dimensional; Address; Adoption; Advanced Development; Animal Model; Animal Testing; Animals; Aorta; Aortic Valve Stenosis; Arteries; Atherosclerosis; Biological Models; Blood Vessels; Bypass; Cadaver; Cardiac; Cardiac Surgery procedures; Cardiology; Cardiovascular system; Catheters; Circulation; Development; Devices; Diameter; Diffuse; Family suidae; Femoral vein; Femur; Fluoroscopy; Genetic Crossing Over; Goals; Health; Heart; Heart Valves; Image; Implant; In Vitro; Inferior vena cava structure; International; Ischemia; Location; Magnetism; Medical center; Methods; Modeling; Morbidity - disease rate; Neodymium; Obstruction; Operative Surgical Procedures; Outcome; Patients; Peripheral; Persons; Phase; Procedures; Process; Pump; Puncture procedure; Recovery; Risk; Risk Reduction; Safety; Stents; Stroke; Surgeon; Surgical complication; System; Testing; Time; Tissues; Veins; Venous; Venous system; Work; abdominal aorta; aortic valve; aortic valve replacement; cardiac device; commercialization; design; experience; femoral artery; heart valve replacement; hemodynamics; human old age (65+); iliac artery; implantation; improved; improved outcome; in vitro testing; innovation; left ventricular assist device; manufacture; minimally invasive; mortality; new technology; novel strategies; patient population; porcine model; pressure; prevent; product development; prototype; radial artery; radiological imaging; success

Project Summary Minimally invasive cardio-thoracic approaches, such as transcatheter aortic valve replacement (TAVR), have recently overtaken traditional surgical methods due to significant reductions in procedural mortality, morbidity, and improved time to recovery. Transfemoral access of the heart via the femoral artery is the most common approach for delivery of large bore devices such as heart valves and left ventricular assist devices (LVAD). Despite improvements in health outcomes through transfemoral percutaneous approaches, large bore catheter sheaths are used that cannot be inserted safely in approximately 20% of patients because of small vessel diam- eter, diffuse atherosclerotic disease, or extensive tortuosity. Transcaval access to the heart has emerged as a new approach to introducing large bore devices into the abdominal aorta, with the donor catheter entering from the femoral vein and the receiver catheter entering from the radial artery, aligning in the inferior vena cava, and crossing over to the aorta. It is vastly superior to transfemoral access due to lower pressure and increased controllability that results from the reduced tortuosity of the venous system, reduced propensity for obstruction, and large size of the veins. However, transcaval access is technically challenging, requiring multiple fluoroscopic viewing angles and operators, which limits its use to specialized medical centers. MagPAD is developing the MagPAD (Magnetic Puncture, Access, and Delivery) device, a cardiac catheter de- livery system that uses magnets to simplify transcaval access to the heart, for large bore access through the venous system. The system employs magnets that are embedded in the leading ends of catheters that automat- ically aligns the catheters and brings the inferior vena cava and aorta closer in 3-dimensional space to simplify crossover to the aorta. This has potential to substantially reduce the difficulty of the process, as it removes the variability in time and difficulty in each procedure by eliminating the need for multiple fluoroscopic viewing angles and potentially multiple operators that are necessary to accurately traverse the guidewire through the snare in three-dimensions. Prior to this Phase I proposal, MagPAD has developed an early prototype catheter and demonstrated magnetic auto-alignment in a porcine cadaveric model. The goal of this project will be to develop a functional prototype and demonstrate feasibility for magnetic alignment, tissue approximation, and guidewire crossover into the aorta in a live porcine model. Success with these goals will substantially lower the barrier to adoption for transcaval procedures, expand access to more patients that are unsuitable for transfemoral TAVR, and improve health outcomes by accessing the heart through the venous system which may reduce vascular complications and risks of ischemia and stroke across all patients

项目摘要 微创心胸手术，如经导管主动脉瓣置换术(TAVR)，有 最近取代了传统的手术方法，因为程序死亡率、发病率、 并缩短了康复时间。最常见的是通过股动脉经股动脉进入心脏。 大口径装置的输送方法，如心脏瓣膜和左心室辅助装置(LVAD)。 尽管通过经股动脉经皮途径改善了健康结局，但大口径导管 大约20%的患者使用的鞘不能安全插入，因为血管直径小- 弥漫性动脉粥样硬化性疾病，或广泛的曲折。经下腔静脉途径进入心脏已成为一种 将大口径装置引入腹主动脉的新方法，供体导管从 股静脉和接收导管从桡动脉进入，在下腔静脉中对齐，以及 穿过大动脉。由于更低的压力和更大的压力，它大大优于经股动脉入路 可控性，这是由于静脉系统的曲折性减少，阻塞倾向减少， 和粗大的静脉。然而，经下腔静脉入路在技术上具有挑战性，需要多次透视。 视角和操作员，这限制了它在专业医疗中心的使用。 MagPAD正在开发MagPAD(磁性穿孔、进入和输送)设备，这是一种心脏导管去... 一种使用磁铁来简化通过下腔静脉进入心脏的系统，用于通过 静脉系统。该系统使用嵌入在导管前端的磁铁，可以自动- 在三维空间中对齐导管，并使下腔静脉和主动脉更近，以简化 交叉连接到大动脉。这有可能大大降低这一过程的难度，因为它消除了 通过消除对多个透视视角的需要，在每个过程中的时间和难度的可变性 和潜在的多个操作员，这些操作员是准确地穿过陷阱中的导丝所必需的 三维的。在此第一阶段提案之前，MagPAD已经开发了早期原型导管和 在猪身体模型中演示了磁力自动对准。该项目的目标将是开发 一个功能原型，并演示了磁对准、组织近似和导丝的可行性 在活体猪模型中交叉进入大动脉。这些目标的成功将大大降低 采用经下腔静脉手术，扩大对更多不适合经股动脉TAVR的患者的接触， 通过静脉系统进入心脏来改善健康状况，这可能会减少血管 所有患者的缺血和中风的并发症和风险