Magnetic Rotational Exploratory Platform for Coronary Lesions

冠状动脉病变磁旋转探索平台

• 批准号: 10384033
• 负责人: Richard Gordon Bach
• 金额: $ 45.64万
• 依托单位: UNANDUP, LLC
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-01-01 至 2023-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10384033
• 关键词: 3D Print; Acute; Adult; Angiography; Animal Model; Animals; Atherectomy; Blood; Blood Vessels; Blood flow; Cadaver; Cardiac; Cardiology; Cardiovascular Diseases; Catheters; Cause of Death; Cessation of life; Chronic; Coronary heart disease; Coupled; Dangerousness; Data Set; Dental crowns; Device Designs; Devices; Diamond; Distal; Economic Burden; Eligibility Determination; Encapsulated; Excision; Feasibility Studies; Friction; Generations; Glycerol; Goals; Gold; Heart; Heating; Human; In Vitro; Innovation Corps; Institution; Intervention; Irrigation; Laboratories; Legal patent; Length; Lesion; Magnetic Resonance Imaging; Magnetism; Manuals; Maps; Measurement; Measures; Mechanics; Methodology; Modeling; Myocardial Infarction; Outcome; Pathway interactions; Perforation; Performance; Phase; Positioning Attribute; Powder dose form; Procedures; Publishing; Research; Risk; Robotics; Rotation; Rotational Atherectomies; Services; Speed; State Hospitals; Stents; Surface; System; Testing; Time; To specify; Torque; Traumatic injury; Tumor Debulking; Underserved Population; United States; United States National Institutes of Health; Viscosity; arm; base; biomaterial compatibility; calcification; comparative efficacy; coronary artery calcification; coronary lesion; cost; design; effective therapy; efficacy study; heat injury; improved; in vivo; magnetic field; meetings; mortality; negative affect; novel; percutaneous coronary intervention; portability; pre-clinical; prevent; prototype; safety assessment; safety study; safety testing; tool; ultrasound

Cardiovascular disease (CVD) is the leading cause of mortality in the United States (US), resulting in 850,000 annual deaths, of which nearly 400,000 are associated with coronary heart disease (CHD) and myocardial infarction (MI). By 2030, global annual deaths will exceed 20 million. More than 90 million US adults currently live with CVD, which is associated with an annual economic burden of more than $330 billion. Together, MI and CHD are the most expensive conditions treated in US hospitals, totaling more than $20 billion each year, with costs expected to double by 2030. Percutaneous coronary intervention (PCI) is an effective strategy to restore blood flow for obstructive CHD. However, while nearly 950,000 PCI procedures are performed each year in the US, navigating tortuous vessels is challenging and enabling stent expansion within severely calcified occlusions often fails, which are observed in ~35% and ~20% of procedures, respectively. Rotational atherectomy (RA) and orbital atherectomy (OA) are increasingly used to debulk otherwise untreatable lesions to enable PCI, with recent studies confirming RA and OA improve stent deliverability vs. standard PCI without negatively affecting outcomes. To debulk severely calcified lesion, RA/OA devices employ long (>300cm) stiff driveshafts which spin burrs/crowns at speeds up to 180,000 RPM. For both RA and OA, the inflexible driveshaft often hinders access within tortuous vasculature. The high speeds employed are necessary to stabilize the burr/crown about a guidewire, without which, the tip would dangerously whip. However, the need for extreme rotational speeds greatly increases the complexity of RA/OA systems and presents risks, which include 1) thermal injury due to driveshaft friction, 2) arterial abrasion and perforation, 3) guidewire shattering, 4) burr/crown entrapment, and 5) embolic debris within the distal vasculature. To reduce the risk of traumatic injury, RA and OA devices cannot be used for more than five minutes. UNandUP has developed an interventional cardiology platform consisting of a magnetic access guidewire and an over-the-wire rotational atherectomy catheter which are controlled using magnetic fields 100X weaker than an MRI. The magnetic guidewire overcomes vessel tortuosity to improve lesion access, a desirable feature for PCI in general. For the magnetic atherectomy catheter, applying magnetic forces directly to the burr eliminates the need for 100X higher driveshaft speeds to stabilize tip rotation. Resultingly, safer and more efficacious debulking is achieved. Further, driveshaft removal enables concurrent aspiration of embolic debris near the burr, a feature not possible with current atherectomy devices. The team reflects leading cardiology, RA/OA, magnetics, and robotics experts. The company maintains partnerships with leading national laboratories and recently completed an FDA presubmission meeting and I-Corps participation. The proposal’s aims include building a prototype magnet system, building magnetic guidewire and atherectomy devices, and evaluating the system’s performance in tortuous cardiac phantoms and published lesion models.

心血管疾病(CVD)是美国死亡的主要原因，导致850,000人死亡 每年死亡，其中近40万人与冠心病(CHD)和心肌梗塞有关 心肌梗死(MI)。到2030年，全球每年死亡人数将超过2000万人。目前有9000多万美国成年人 与心血管疾病一起生活，这与每年超过3300亿美元的经济负担有关。一起，密歇根州 和冠心病是美国医院治疗费用最高的疾病，每年总计超过200亿美元， 预计到2030年，成本将翻一番。经皮冠状动脉介入治疗是一种有效的治疗方法。 恢复梗阻性冠心病的血流。然而，虽然每次都要执行近950,000个PCI程序 在美国，航行曲折的血管是具有挑战性的，并使支架在严重的 钙化闭塞经常失败，分别在~35%和~20%的手术中观察到。 旋转动脉粥样硬化术(RA)和眼眶动脉粥样硬化术(OA)越来越多地被用来去除其他方面的障碍 不可治疗的病变，以实现经皮冠状动脉介入治疗，最近的研究证实，RA和OA可以改善支架的交付能力。 标准的经皮冠状动脉介入治疗，不会对结果产生负面影响。要清除严重钙化的病变，RA/OA设备 使用长(&gt；300厘米)硬质传动轴，其旋转毛刺/牙冠的速度高达180,000 RPM。对于两个RA 而OA，僵硬的传动轴经常阻碍曲折的血管系统内的通路。所采用的高速 是将毛刺/牙冠固定在导丝周围所必需的，如果没有导丝，尖端将危险地鞭打。 然而，对极端转速的需求极大地增加了RA/OA系统的复杂性 存在风险，包括1)驱动轴摩擦造成的热损伤，2)动脉磨损和穿孔，3) 导丝断裂，4)毛刺/牙冠卡住，5)远端血管内的栓塞物碎片。减少 创伤性损伤的风险，RA和OA设备不能使用超过五分钟。 UNAND UP开发了一个由磁性导丝组成的介入心脏病学平台 以及使用弱100倍磁场控制的线控旋转动脉粥样硬化导管 而不是做核磁共振。磁性导丝克服了血管的曲折，改善了病变的通达，这是一种理想的 总体上适用于PCI的功能。对于磁性动脉粥样硬化导管，直接对毛刺施加磁力 无需将传动轴速度提高100倍即可稳定刀尖旋转。结果是，更安全、更 实现了有效的开挖。此外，拆卸传动轴能够同时吸入栓子碎片 在毛刺附近，这是目前的动脉粥样硬化设备不可能实现的特征。该团队反映了领先的心脏病学， RA/OA、磁学和机器人专家。该公司与全国领先的 实验室和最近完成了FDA的预提交会议和i-Corps的参与。该提案的 目标包括建造一个原型磁体系统，建造磁性导丝和动脉切割术设备，以及 评估该系统在曲折的心脏幻影和已发表的损伤模型中的性能。