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; 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 最小侵入性心脏胸膜方法，例如经导管主动脉瓣置换（TAVR） 最近由于程序死亡率大大降低，发病率大大降低而超过了传统的手术方法 并提高了恢复时间。通过股动脉的心脏传播是最常见的 输送大孔设备（例如心脏瓣膜和左心室辅助设备（LVAD））的方法。 尽管通过经常性经皮方法改善了健康结果，但大孔导管 由于小血管diam- ETER，弥漫性动脉粥样硬化疾病或广泛的曲折。跨诊断进入心脏的机会已成为 将大孔设备引入腹主动脉的新方法，供体导管从 股静脉和接收器导管从radial动脉进入，在下腔静脉中对齐， 越过主动脉。由于压力较低和增加 可控性是由于静脉系统曲折性降低而导致的可控性，阻塞倾向降低， 和静脉的大尺寸。但是，跨诊所的通道在技术上具有挑战性，需要多次荧光镜检查 查看角度和操作员，将其用于专业医疗中心的使用限制。 Magpad正在开发Magpad（磁性穿刺，通道和输送设备），这是一种心脏导管 使用磁铁来简化跨诊断对心脏的访问的涂装系统，以通过 静脉系统。该系统采用嵌入在自动化导管的领先端的磁铁 - 在3维空间中，我将导管对准导管，并使下腔静脉和主动脉更接近 交叉到主动脉。这有可能大大减少该过程的难度，因为它消除了该过程 通过消除对多个荧光镜观看角度的需求，时间和难度的差异和难度 以及潜在的多个操作员，这些操作员是准确地穿越导丝的必要的操作员 三维。在此阶段I提案之前，Magpad已开发了早期的原型导管， 在猪尸体模型中展示了磁自动对准。该项目的目标是开发 功能性原型，并证明了磁对齐，组织近似和导丝的可行性 在活猪模型中跨越主动脉。实现这些目标的成功将大大降低 采用跨诊断程序，扩展更多不适合thrspremoral tavr的患者的访问权限， 并通过通过静脉系统进入心脏来改善健康结果，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