Cavopulmonary Assist: Circulatory Support for Fontan Circulation

腔静脉辅助：Fontan 循环的循环支持

基本信息

批准号：
8460133
负责人：
MARK D RODEFELD
金额：
$ 41.79万
依托单位：
INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
依托单位国家：
美国
项目类别：
财政年份：
2010
资助国家：
美国
起止时间：
2010-08-01 至 2016-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8460133
关键词：
Acute Address Adult Anatomy Animal Model Assisted Circulation Biomechanics Blood Circulation Blood Vessels Blood flow Cardiac Output Cardiopulmonary Bypass Catheters Cause of Death Characteristics Chemistry Child Chronic Clinical Common Ventricle Complex Congenital Abnormality Data Defect Dependence Devices Disease Elastomers Environment Equilibrium Face Failure Feedback Goals Health Healthcare Heart Diseases Hemolysis Human Hypoplastic Left Heart Syndrome Hypoxemia Imagery In Vitro Left ventricular structure Life Liquid substance Lung Lung diseases Measures Metallurgy Methods Modeling Neonatal Newborn Infant Obstruction Operative Surgical Procedures Pathway interactions Patients Pattern Performance Physiological Physiology Plant Roots Power Sources Procedures Public Health Pulmonary Circulation Pulmonary Vascular Resistance Pulmonary artery structure Pump Right ventricular structure Risk Rotation Series Shunt Device Side Solutions Source Staging Surface Survivors Technology Testing Time Vena caval structure Venous Venous Pressure level Ventricular base biomaterial compatibility blood pump design disability hemodynamics improved in vitro Model in vivo innovation insight mortality neonate nitinol normotensive operation pressure public health relevance repaired treatment strategy vascular bed

项目摘要

DESCRIPTION (provided by applicant): Treatment of single functional ventricle is indisputably a significant healthcare challenge. It is the leading cause of death from any birth defect in the first year of life. Those who are fortunate to survive face lifelong disability for which there is no direct therapy, constituting an emerging public health concern. Currently, repair is performed in a complex series of 3 staged operations which are notorious for instability and mortality. This is attributable to the use of a systemic arterial shunt to provide a substantive source of pulmonary blood flow in the neonate. The endpoint of repair is a univentricular Fontan circulation, in which the vena cavae are connected to the pulmonary artery. Because there is no right-sided ventricular power source, venous return is profoundly altered and filling of the single ventricle is suboptimal. We have theorized that a means to modestly augment existing Fontan cavopulmonary flow (6-8 mmHg) would address these problems by reproducing more stable two-ventricle physiology and permitting stabilization and/or compression of surgical stages. Gradual reduction in support would permit adaptation to the higher pressure needed (10-15 mmHg) for a systemic venous source to independently perfuse the lungs. The functional parameters for a blood pump to provide low- pressure support in the complex 4-way flow anatomy of a cavopulmonary connection are markedly dissimilar to any other circulatory assist application: No such pump currently exists. We hypothesize that an actuator disk pump, based on the von Karman viscous pump, is optimal to provide cavopulmonary assist. With only one impeller, a catheter-based expandable rotary disk provides the preferred low-pressure, high-volume flow in 4 opposing directions without risk of venous pathway obstruction. To develop this breakthrough innovation, our specific aims are to: 1) characterize the upstream, local, and downstream flow patterns induced by rotation of a central stabilizing body (actuator disk) within a 3-way "T" and 4-way "t" cavopulmonary connection, 2) define the optimal geometric and surface characteristics of a bi-conical expandable rotary impeller to augment cavopulmonary flow using advanced numerical modeling and flow visualization, 3) optimize the hemodynamic, biocompatibility, and thrombogenicity performance of a rotary disk pump through in vitro feedback from mock flow loop, flow visualization, and hemolysis studies, 4) demonstrate percutaneous viscous pump support in an animal model of univentricular Fontan circulation. We will accomplish these aims by intersecting expertise in: computational fluid dynamic modeling; surface streamlining; flow visualization; in vitro modeling; physiologic control; thrombogenicity; elastomer chemistry; nitinol metallurgy; microcoil fabrication; catheter disposables; rotary blood pump design; prototyping; and clinically rooted in vivo studies. At completion, an easily implemented percutaneous technology which dramatically improves Fontan circulatory status will be delivered as a predicate device to clinical use. In patients with univentricular Fontan circulations - young and old - this safe, simple, and reliable method to augment cavopulmonary flow will address their unresolved health needs.

描述（由申请人提供）：单功能心室的治疗无疑是一项重大的医疗挑战。它是出生后第一年因出生缺陷而死亡的主要原因。那些幸运活下来的人将面临无法直接治疗的终身残疾，这构成了一个新出现的公共卫生问题。目前，修复是通过一系列复杂的三阶段手术进行的，这些手术因不稳定和死亡率而臭名昭著。这归因于使用全身动脉分流来为新生儿提供肺血流的实质性来源。修复的终点是单心室 Fontan 循环，其中腔静脉与肺动脉相连。由于没有右心室动力源，静脉回流发生了深刻的改变，单心室的充盈也不是最理想的。我们推测，适度增加现有 Fontan 腔肺血流 (6-8 mmHg) 的方法将通过再现更稳定的两心室生理学并允许手术阶段的稳定和/或压缩来解决这些问题。逐渐减少支持将允许适应系统静脉源独立灌注肺部所需的较高压力（10-15 mmHg）。在腔肺连接的复杂四向流动解剖结构中提供低压支持的血泵的功能参数与任何其他循环辅助应用明显不同：目前不存在这样的泵。我们假设基于冯卡门粘性泵的执行器盘泵最适合提供腔肺辅助。仅用一个叶轮，基于导管的可膨胀旋转盘即可在 4 个相反方向上提供首选的低压、大流量流量，而不会出现静脉通路阻塞的风险。为了开发这一突破性创新，我们的具体目标是：1) 表征由中央稳定体（执行器盘）在 3 向“T”和 4 向“t”内旋转引起的上游、局部和下游流型。 “ 腔肺连接，2) 定义双锥可膨胀旋转叶轮的最佳几何和表面特征，以使用先进的数值建模和流动可视化增强腔肺流动，3) 优化血液动力学，通过来自模拟流动回路、流动可视化和溶血研究的体外反馈，验证转盘泵的生物相容性和血栓形成性能，4) 在单心室 Fontan 循环动物模型中证明经皮粘性泵支持。我们将通过交叉专业知识来实现这些目标：计算流体动力学建模；表面流线化；流程可视化；体外建模；生理控制；血栓形成性；弹性体化学；镍钛合金冶金；微线圈制造；一次性导管；旋转式血泵设计；原型制作；以及临床植根于体内的研究。完成后，一种可显着改善 Fontan 循环状态的易于实施的经皮技术将作为预测设备提供给临床使用。对于患有单心室 Fontan 循环的患者（无论年轻还是年长），这种安全、简单且可靠的增加腔静脉肺流量的方法将解决他们尚未解决的健康需求。

项目成果

期刊论文数量（11）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

Dynamic Mode Decomposition of Fontan Hemodynamics in an Idealized Total Cavopulmonary Connection.

理想化全腔肺连接中 Fontan 血流动力学的动态模式分解。

DOI：
10.1088/0169-5983/46/4/041425
发表时间：
2014
期刊：
Fluid dynamics research
影响因子：
1.5
作者：
Delorme,YannT;Kerlo,Anna-ElodieM;Anupindi,Kameswararao;Rodefeld,MarkD;Frankel,StevenH
通讯作者：
Frankel,StevenH

Performance evaluation of a pediatric viscous impeller pump for Fontan cavopulmonary assist.

DOI：
10.1016/j.jtcvs.2012.01.082
发表时间：
2013-01
期刊：
JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY
影响因子：
6
作者：
Giridharan, Guruprasad A.;Koenig, Steven C.;Kennington, Jeffrey;Sobieski, Michael A.;Chen, Jun;Frankel, Steven H.;Rodefeld, Mark D.
通讯作者：
Rodefeld, Mark D.

Assessment of stretched vortex subgrid-scale models for LES of incompressible inhomogeneous turbulent flow.

不可压缩非均匀湍流 LES 拉伸涡亚网格尺度模型的评估。