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）是美国死亡率的主要原因（美国），导致85万 年死亡，其中近40万与冠状动脉疾病（CHD）和心肌有关 梗塞（MI）。到2030年，全球年度死亡将超过2000万。目前超过9000万美国成年人 与CVD一起生活，这与年度经济燃烧超过3,300亿美元有关。在一起，mi 冠心病是美国医院治疗的最昂贵的疾病，每年总计超过200亿美元， 预计到2030年的成本将翻倍。经皮冠状动脉干预（PCI）是一种有效的策略 恢复阻塞性冠心病的血流。但是，每次执行了将近950,000个PCI程序 在美国，导航曲折的视频具有挑战性，并使支架在严重的内部扩展 钙化的闭塞通常会失败，分别在约35％和约20％的手术中观察到。 旋转动力控制术（RA）和轨道动脉切除术（OA）越来越多地用于脱身 最近的研究确认了RA和OA改善支架递送VS。 标准PCI而没有负面影响结果。要删除严重计算的病变，RA/OA设备 员工长（> 300厘米）的刚性驱动轴以高达180,000 rpm的速度旋转毛刺/冠。对于两个RA OA，不灵活的驱动轴通常会阻碍曲折的脉管系统中的访问。使用的高速 对于在导线上稳定Burr/Crown是必要的，否则，尖端会危险地鞭打。 但是，对极端旋转速度的需求大大增加了RA/OA系统的复杂性和 提出风险，其中包括1）由于摩擦摩擦而引起的热损伤，2）动脉磨损和穿孔，3） Guidewire粉碎，4）毛刺/冠夹，5）远端脉管系统内栓塞碎片。减少 创伤，RA和OA设备的风险不能超过五分钟。 UnAndup开发了一个介入的心脏病学平台，该平台由磁性访问导线组成 和线上的旋转动脉切除术导管，该导管使用磁场弱100倍控制 比MRI。磁性导线克服了血管曲折以改善病变的进入，这是理想的 PCI一般的功能。对于磁性动脉切除术导管，将磁力直接施加到毛刺 消除了对稳定尖端旋转的100倍驱动轴速度的需求。因此，更安全 实现了简单的剪裁。此外，驱动轴除去栓塞碎片的同时抽吸 在毛刺附近，目前的动脉切除术设备不可能。团队反映了领先的心脏病学， RA/OA，磁和机器人专家。该公司与领先的国家保持伙伴关系 实验室，最近完成了一次FDA预审会议和I-Corps的参与。提案的 目的包括构建原型磁铁系统，构建磁性导线和动脉切除术设备以及 评估系统在曲折的心脏幻象和已发表病变模型中的性能。