Multifunctional VAD Technology for High-Risk Pediatric Patients

项目总结：继发于获得性或先天性心脏病的心力衰竭儿童的治疗 对临床医生来说是一个巨大的挑战。心脏移植，如果可行，成为唯一的 救命的选择幸运的是，儿童可以从心室辅助装置（VAD）中受益：一种医疗器械 设计用于辅助心脏的左心室（将血液输送到身体）或右心室（将血液输送到 肺）。然而，儿童VAD技术明显落后于成人。虽然成人设备 在非设计条件下操作这些泵， 不规则的血液流动，导致血细胞损伤（溶血）和危险的凝血（血栓形成）。 高风险儿科患者由于其体型而严重限制了选择，并且需要用于一系列 由于儿童心脏病和增加的心血管需求的生理异质性 身体成长这些挑战增加了患者的心力衰竭风险， 这是护理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 创新儿科心血管血泵的临床需求仍然大量未得到满足， 因此，这项研究的长期目标是推进一项具有高影响力的混合型突破性创新， 设计，磁悬浮，医疗器械，独特地集成了两个血泵，用于支持 儿科患者。这种新颖的设备（龙心）只有2个运动部件-轴流泵叶轮， 肺循环和用于体循环的离心泵叶轮。作为混合双设计， 离心泵围绕分离的轴流泵域旋转。该装置利用磁力驱动 系统，以促进更长的运行寿命和更宽的间隙内的泵。更宽的间隙 降低流体应力，从而降低血栓形成和溶血的风险。它将能够产生连续的 或脉动流，并且实现无线能量传输系统以消除腹部传动系统。 该器械结构紧凑（60 mm x 50 mm），可为高风险患者提供生理压力和血流 患有不同程度心力衰竭、解剖缺陷和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，以支持该器械设计的可行性。我们的核心假设是 在离心流血泵内轴流式泵的这种创新的混合集成将 成功地为患有心力衰竭的儿科患者提供多功能心脏支持。这一假设将是 测试的目的是：1）建立最佳的轴流泵和离心泵的几何形状， 通过迭代设计的要求; 2）表征原型达到设计标准的能力， 液压、溶血和幻影MRI流动研究; 3）证明龙心的能力， 机械地支持急性动物模型中的血流。结合我们的跨学科专业知识 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。

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.