Multifunctional VAD Technology for High-Risk Pediatric Patients

项目摘要：后天性或先天性心脏病继发的心力衰竭儿童的治疗 疾病，对临床医生来说是一个巨大的挑战。心脏移植在可行的情况下成为唯一的 救生选项。幸运的是，儿童可以受益于脑室辅助设备(VAD)：一种医疗设备 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VAD技术。而成人设备 已经在儿童中使用，这些泵在非设计条件下的运行增加了潜力 用于血液流动不规律，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，需要一系列设备 儿童心脏病引起的生理异质性和心血管需求的增加 身体的成长。这些挑战增加了患者的心力衰竭风险，创造了实质性的治疗 护理这些儿科患者的团队面临的障碍，并强调了下一代设备的必要性 创新。儿科心血管血泵仍有大量临床需求未得到满足。 因此，这项研究的长期目标是推进一种高影响力的混合动力汽车的突破性创新。 设计磁悬浮医疗设备，独一无二地集成了两个血泵以支持 儿科病人。这种新型装置(龙心)只有两个运动部件-一个轴流泵叶轮，用于 肺循环和用于体循环的离心泵叶轮。作为一种混合双重设计， 离心泵绕独立的轴流泵域旋转。该设备利用磁力驱动器 该系统有助于延长泵的运行寿命和扩大泵内部的间隙。更宽的间隙 降低流体压力，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，并实施无线能量传输系统，以消除腹部传动线。 该设备结构紧凑(60 Mm X 50 Mm)，可为高危人群提供生理压力和血流。 有不同程度心力衰竭、解剖缺陷以及大小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，以支持该设备设计的可行性。我们的中心假设是 轴流泵与离心流血泵的这种创新的混合集成将 成功地为患有心力衰竭的儿童患者提供全方位的心脏支持。这一假设将是 测试的目的是：1)确定达到设计要求的最佳轴流泵和离心泵的几何形状 通过迭代设计的需求；2)通过以下方式表征原型达到设计标准的能力 水力、溶血和体模-核磁共振血流研究；3)证明龙心有能力 在急性动物模型中机械支持血液流动。我们的综合跨学科专业知识 研究团队使我们处于有利地位，可以进一步开发和评估这项创新技术。

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.