Multifunctional VAD Technology for High-Risk Pediatric Patients

适用于高危儿科患者的多功能 VAD 技术

• 批准号: 10418680
• 负责人: Amy Throckmorton
• 金额: $ 38.52万
• 依托单位: DREXEL UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-07-01 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10418680
• 关键词: Abdomen; Achievement; Acute; Adult; Age; Anatomy; Animal Experiments; Animal Model; Biological; Blood; Blood Cells; Blood Circulation; Blood flow; Cannulas; Cardiac; Cardiovascular system; Caring; Cattle; Child; Childhood; Clinical; Coagulation Process; Dangerousness; Data; Defect; Detection; Development; Device Designs; Devices; Energy Transfer; Ensure; Frequencies; Generations; Geometry; Goals; Growth; Heart; Heart Diseases; Heart Transplantation; Heart failure; Hemolysis; Heterogeneity; Hybrids; Impairment; In Vitro; Left ventricular structure; Life; Liquid substance; Longevity; Lung; Magnetic Resonance Imaging; Magnetism; Measurement; Mechanics; Medical Device; Medical Device Designs; Modeling; Motor; Neurologic; Operative Surgical Procedures; Patients; Performance; Physiological; Platelet Activation; Positioning Attribute; Pulmonary Circulation; Pulsatile Flow; Pulse Pressure; Pump; Research; Research Project Grants; Resistance; Right ventricular structure; Risk; Rotation; Secondary to; Stress; Suction; Surface; Suspensions; System; Technology; Testing; Therapeutic; Thrombosis; Thrombus; Time; Trauma; Update; analog; blood damage; blood pump; cardiac magnetic resonance imaging; cell injury; congenital heart disorder; design; hemodynamics; high risk; in silico; in vitro testing; innovation; innovative technologies; iterative design; magnetic field; next generation; novel; operation; pediatric patients; pressure; prototype; ventricular assist device; wireless

PROJECT SUMMARY: The treatment of children with heart failure, secondary to acquired or congenital heart disease, is a formidable challenge for clinicians. Heart transplantation, when available, becomes the only lifesaving option. Fortunately, children can benefit from a ventricular assist device (VAD): a medical device designed to assist the heart's left ventricle (drives blood to the body) or the right ventricle (drives blood to the lungs). However, VAD technologies for children significantly lag behind those for adults. While adult devices have been employed in children, the operation of these pumps at off-design conditions increases the potential for irregular blood flow, contributing to blood cell damage (hemolysis) and dangerous clotting (thrombosis). High-risk pediatric patients have severely limited options due to their size and require devices for a range of physiological heterogeneity due to childhood heart disease and the increased cardiovascular demands of physical growth. These challenges elevate the heart failure risk for patients, create substantial treatment obstacles for teams caring for these pediatric patients, and underscore the need for next-generation device innovation. There still remains a substantial unmet clinical need for pediatric cardiovascular blood pumps, and thus the long-term goal of this research is to advance a breakthrough innovation of a high-impact, hybrid- design, magnetically levitated, medical device that uniquely integrates two blood pumps for supporting pediatric patients. This novel device (The Dragon Heart) has only 2 moving parts - an axial pump impeller for the pulmonary circulation and a centrifugal pump impeller for the systemic circulation. As a hybrid dual design, the centrifugal pump rotates around the separate axial pump domain. The device utilizes a magnetic drive system to facilitate a longer operational lifespan and wider clearances inside of the pumps. Wider clearances lower fluid stresses, hence reducing the risk of thrombosis and hemolysis. It will be able to produce continuous or pulsatile flow, and a wireless energy transfer system is implemented to eliminate the abdominal driveline. The device is compact (60mm x 50mm) and delivers physiologic pressures and blood flows for high-risk pediatric patients with varying levels of heart failure, anatomic defects, and size or age constraints. We have generated compelling preliminary data to support the viability of this device design. Our central hypothesis is that this innovative, hybrid integration of an axial flow pump within a centrifugal flow blood pump will successfully provide versatile cardiac support to pediatric patients with heart failure. This hypothesis will be tested in these Aims: 1) establish the optimal axial and centrifugal pump geometries that achieve design requirements through iterative design; 2) characterize the ability of prototypes to attain design criteria by hydraulic, hemolytic, and phantom-MRI flow studies; 3) demonstrate the ability of the Dragon Heart to mechanically support blood flow in an acute animal model. The combined interdisciplinary expertise of our research team places us in an excellent position to further develop and evaluate this innovative technology.

项目摘要：治疗继发于后天性或先天性心脏病的儿童心力衰竭 疾病的发生，对临床医生来说是一个巨大的挑战。心脏移植一旦可行，将成为唯一的治疗方法 救生选择。幸运的是，儿童可以受益于心室辅助装置 (VAD)：一种医疗设备 旨在协助心脏的左心室（将血液输送到身体）或右心室（将血液输送到身体） 肺）。然而，针对儿童的 VAD 技术明显落后于成人。虽然成人设备 已用于儿童，这些泵在非设计条件下运行会增加潜在的风险 血流不规则，导致血细胞损伤（溶血）和危险的凝血（血栓形成）。 高危儿科患者由于体型较大，选择非常有限，并且需要用于一系列治疗的设备 由于儿童心脏病和心血管需求增加而导致的生理异质性 身体成长。这些挑战增加了患者心力衰竭的风险，创造了实质性的治疗方法 照顾这些儿科患者的团队面临的障碍，并强调了对下一代设备的需求 创新。对儿科心血管血泵的临床需求仍然存在大量未满足的情况，并且 因此，这项研究的长期目标是推进高影响力、混合型的突破性创新。 设计磁悬浮医疗设备，独特地集成了两个血泵以支持 儿科患者。这种新颖的装置（龙心）只有 2 个运动部件 - 一个轴流泵叶轮，用于 肺循环和体循环的离心泵叶轮。作为混合双路设计， 离心泵围绕单独的轴流泵域旋转。该设备利用磁力驱动 系统有利于延长泵的使用寿命并扩大泵内部的间隙。更宽的间隙 降低液体压力，从而降低血栓形成和溶血的风险。它将能够连续生产 或脉动流，并采用无线能量传输系统来消除腹部动力传动系统。 该设备结构紧凑（60mm x 50mm），可为高危人群提供生理压力和血流量 患有不同程度的心力衰竭、解剖缺陷以及体型或年龄限制的儿科患者。我们有 生成了令人信服的初步数据来支持该设备设计的可行性。我们的中心假设是 这种轴流泵与离心流血泵的创新混合集成将 成功地为患有心力衰竭的儿科患者提供多功能心脏支持。这个假设将是 在这些目标中进行测试：1) 建立实现设计的最佳轴向和离心泵几何形状 通过迭代设计满足需求； 2) 表征原型达到设计标准的能力 液压、溶血和模体 MRI 流动研究； 3）展示龙心的能力 在急性动物模型中机械支持血流。我们的综合跨学科专业知识 研究团队使我们处于进一步开发和评估这项创新技术的绝佳位置。