A Structured Approach to the Design of Minimally Traumatic Blood Pumps

微创血泵设计的结构化方法

• 批准号: 9924643
• 负责人: KEEFE B MANNING
• 金额: $ 61.74万
• 依托单位: PENNSYLVANIA STATE UNIV HERSHEY MED CTR
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-05-25 至 2022-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9924643
• 关键词: Address; Adhesions; Adverse effects; Adverse event; Animal Testing; Animals; Anticoagulation; Artificial Heart; Blood; Blood Platelets; Cardiovascular system; Clinical; Clinical Data; Clinical Trials; Coagulation Process; Code; Communication; Complex; Computer Models; Computer Simulation; Computing Methodologies; Couples; Critical Pathways; Destinations; Development; Devices; Geometry; Goals; Heart; Heart Valves; Heart failure; Hemolysis; Hemorrhage; Immune system; Implant; In Vitro; Individual; Ischemic Stroke; Liquid substance; Location; Measures; Methods; Modeling; Morbidity - disease rate; Operative Surgical Procedures; Patients; Performance; Phase; Physics; Platelet Activation; Predisposition; Process; Pulsatile Flow; Pump; Reporting; Research; Resolution; Safety; Severities; Site; Source Code; Speed; Stroke; Structure; Study models; Surgical complication; System; Testing; Therapeutic Embolization; Thromboembolism; Thrombosis; Thrombus; Time; Transplantation; United States Food and Drug Administration; Whole Blood; base; blood damage; blood pump; computational platform; design; improved; in vivo; left ventricular assist device; models and simulation; open source; pre-clinical; preclinical development; prototype; shear stress; simulation; stroke incidence; temporal measurement; tool; ventricular assist device

Project Summary / Abstract The objective of this research is to develop improved analytical and experimental methods used in a structured approach for the design of blood pumps with reduced potential for adverse events. We propose to continue our efforts focusing on the development of a computational platform using an open source code that integrates and couples shear-induced blood damage, thrombosis susceptibility potential, platelet activation, and thrombosis models simultaneously during the design process. Currently, only hemolysis models are used in the design phase and platelet activation used in rare cases, but neither has been integrated into a single computational model simultaneously. Our use of large eddy simulation computational fluid dynamics (CFD) provides a flow field capturing much of the turbulent flow field. We will apply this structured approach on a prototype bladed rotary ventricular assist device (VAD) that we are developing. To accomplish these goals, we will focus on the following specific aims: 1. Integrate a newly developed shear-induced blood damage model based upon dissipation (7), a thrombosis susceptibility potential (TSP) (8-10), and a platelet activation model (11) into a single computational platform to design a rotary blood pump incorporating the interaction of the VAD and native heart pulsatility. This research is intended to culminate in inclusion of a continuum-based macroscopic thrombosis model to refine the pump design. 2. Develop a continuum-based macroscopic thrombosis model for both laminar and turbulent flow and shear induced platelet activation that will be used to refine the pump design. The thrombosis model will be validated through in vitro platelet adhesion studies using a rotating disk system (RDS), an in vitro backward facing step (BFS) model using whole blood, and clinical LVAD patients. 3. Perform in vivo animal studies of a prototype rotary VAD system in non-anticoagulated animals to a) assess location, severity, and time course of thrombosis and embolization, b) study the effect of pump speed and pulsatile flow, and c) measure platelet activation, global coagulation, and hemolysis. This research will yield improved design and analysis tools in a structured approach that will be applicable to a broad range of blood pumps and blood contacting cardiovascular devices.

项目摘要 /摘要 这项研究的目的是开发结构化的改进的分析和实验方法 设计血液泵具有降低不良事件潜力的方法。我们建议继续我们的 专注于使用集成的开源代码开发计算平台的努力 以及夫妻剪切引起的血液损伤，血栓形成易感性潜力，血小板激活和 血栓形成在设计过程中同时模型。目前，仅在 在极少数情况下使用的设计阶段和血小板激活，但两者都不集成到单个 同时计算模型。我们使用大型涡流计算流体动力学（CFD） 提供一个流场捕获大部分湍流场。我们将把这种结构化方法应用于 我们正在开发的原型叶片旋转心室辅助装置（VAD）。为了实现这些目标，我们 将重点关注以下特定目标： 1。基于耗散（7）的新开发的剪切诱导的血液损伤模型 敏感性电位（TSP）（8-10），将血小板激活模型（11）用于单个计算 平台设计旋转血泵，结合了VAD的相互作用和天然心脏脉动的相互作用。 这项研究旨在将基于连续的宏观血栓形成模型包括在内 完善泵设计。 2。为层流和湍流和剪切开发基于连续的宏观血栓形成模型 诱导的血小板激活将用于完善泵设计。血栓形成模型将是 通过旋转磁盘系统（RDS）的体外血小板粘附研究验证，体外向后 使用全血和临床LVAD患者面对步骤（BFS）模型。 3。对非期权动物的原型旋转VAD系统进行体内动物研究 评估血栓形成和栓塞的位置，严重程度以及时间过程，b）研究泵的影响 速度和脉动流动，c）测量血小板激活，全局凝血和溶血。 这项研究将以结构化方法的改进设计和分析工具，适用于 广泛的血泵和血液接触的心血管装置。