Multifunctional VAD Technology for High-Risk Pediatric Patients

适用于高危儿科患者的多功能 VAD 技术

基本信息

批准号：
10883981
负责人：
Amy Throckmorton
金额：
$ 1.02万
依托单位：
DREXEL UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-07-01 至 2025-06-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10883981
关键词：
Abdomen Achievement Acute Adult Age Anatomy Animal Experiments Animal Model Biological Blood Blood Cells Blood flow Cannulas Cardiac Cardiovascular system Caring Cattle Child Childhood Circulation 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 Risk Reduction 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 improved in silico in vitro testing innovation innovative technologies iterative design magnetic field next generation novel operation pediatric patients pressure prototype ventricular assist device wireless

项目摘要

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：对心力衰竭儿童的治疗，继发于获得或先天性心脏疾病是临床医生的巨大挑战。心脏移植（如果可用）成为唯一的救生选项。幸运的是，儿童可以从心室辅助设备（VAD）中受益：医疗设备旨在帮助心脏的左心室（将血液驱动到身体）或右心室（将血液驱动到肺）。但是，儿童的VAD技术显着落后于成年人。而成人设备这些泵在非设计条件下的操作已被雇用，增加了潜力对于不规则的血流，导致血细胞损伤（溶血）和危险的凝结（血栓形成）。高风险的小儿患者由于尺寸而具有严重有限的选择，并且需要设备由于儿童心脏病引起的生理异质性以及心血管需求增加身体成长。这些挑战提高了患者的心力衰竭风险，创造了大量治疗照顾这些小儿患者的团队的障碍，并强调了对下一代设备的需求创新。对于小儿心血管血液泵和因此，这项研究的长期目标是提高高影响力，混合动力的突破性创新设计，磁悬浮的医疗设备，独特地整合了两个血泵以支持小儿患者。这个新颖的设备（龙心）只有2个运动部件 - 轴向泵叶轮用于全身循环的肺循环和离心泵叶轮。作为混合双重设计，离心泵围绕单独的轴向泵域旋转。该设备利用磁性驱动器系统以促进泵内部更长的操作寿命和更广泛的间隙。更广泛的间隙降低液体应激，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冲流，并实现无线能量转移系统以消除腹部传动系统。该设备紧凑（60mm x 50mm），并为高风险提供生理压力和血流心力衰竭，解剖缺陷以及大小或年龄限制的儿科患者。我们有生成了引人入胜的初步数据，以支持该设备设计的可行性。我们的中心假设是在离心流动泵内轴向流动泵的创新性，混合整合将成功地为心力衰竭的小儿患者提供多功能心脏支持。这个假设将是在这些目标中测试：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的要求； 2）表征原型通过液压，溶血和幻影-MRI流量研究； 3）演示龙之心的能力机械支持急性动物模型中的血流。我们的组合跨学科专业知识研究团队使我们处于进一步发展和评估这一创新技术的绝佳位置。

项目成果

期刊论文数量（6）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

Integrated long-term multifunctional pediatric mechanical circulatory assist device.

DOI：
10.1111/aor.13863
发表时间：
2021-05
期刊：
Artificial organs
影响因子：
2.4
作者：
通讯作者：

Novel hybrid total artificial heart with integrated oxygenator.

DOI：
10.1111/jocs.17210
发表时间：
2022-12
期刊：
JOURNAL OF CARDIAC SURGERY
影响因子：
1.6
作者：
Chopski, Steven G. G.;Govender, Krianthan;May, Alexandra;Garven, Ellen;Stevens, Randy M. M.;Tchantchaleishvili, Vakhtang;Throckmorton, Amy L. L.
通讯作者：
Throckmorton, Amy L. L.

Development of the Centrifugal Blood Pump for a Hybrid Continuous Flow Pediatric Total Artificial Heart: Model, Make, Measure.

DOI：
10.3389/fcvm.2022.886874
发表时间：
2022
期刊：
FRONTIERS IN CARDIOVASCULAR MEDICINE
影响因子：
3.6
作者：
Fox, Carson S.;Palazzolo, Thomas;Hirschhorn, Matthew;Stevens, Randy M.;Rossano, Joseph;Day, Steven W.;Tchantchaleishvili, Vakhtang;Throckmorton, Amy L.
通讯作者：
Throckmorton, Amy L.

Channel impeller design for centrifugal blood pump in hybrid pediatric total artificial heart: Modeling, magnet integration, and hydraulic experiments.