Department of Mathematics, University of North Carolina, Chapel Hill, NC, USA.
Division of Applied Mechanics, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, United States Food and Drug Administration, Silver Spring, MD, USA.
Ann Biomed Eng. 2020 May;48(5):1475-1490. doi: 10.1007/s10439-020-02466-4. Epub 2020 Feb 7.
Computer modeling and simulation is a powerful tool for assessing the performance of medical devices such as bioprosthetic heart valves (BHVs) that promises to accelerate device design and regulation. This study describes work to develop dynamic computer models of BHVs in the aortic test section of an experimental pulse-duplicator platform that is used in academia, industry, and regulatory agencies to assess BHV performance. These computational models are based on a hyperelastic finite element extension of the immersed boundary method for fluid-structure interaction (FSI). We focus on porcine tissue and bovine pericardial BHVs, which are commonly used in surgical valve replacement. We compare our numerical simulations to experimental data from two similar pulse duplicators, including a commercial ViVitro system and a custom platform related to the ViVitro pulse duplicator. Excellent agreement is demonstrated between the computational and experimental results for bulk flow rates, pressures, valve open areas, and the timing of valve opening and closure in conditions commonly used to assess BHV performance. In addition, reasonable agreement is demonstrated for quantitative measures of leaflet kinematics under these same conditions. This work represents a step towards the experimental validation of this FSI modeling platform for evaluating BHVs.
计算机建模和模拟是评估医疗设备性能的强大工具,例如生物假体心脏瓣膜(BHV),有望加速设备设计和监管。本研究描述了在学术、工业和监管机构中用于评估 BHV 性能的实验脉动复制器平台的主动脉测试部分中开发 BHV 的动态计算机模型的工作。这些计算模型基于用于流固耦合(FSI)的浸入边界方法的超弹性有限元扩展。我们专注于猪组织和牛心包 BHV,它们通常用于外科瓣膜置换。我们将我们的数值模拟与来自两个类似脉动复制器的实验数据进行了比较,包括一个商业的 Vititro 系统和一个与 Vititro 脉动复制器相关的定制平台。在常用于评估 BHV 性能的条件下,计算结果和实验结果在总体流量、压力、阀开口面积以及阀开启和关闭的时间方面表现出极好的一致性。此外,在相同条件下,还对瓣叶运动学的定量测量进行了合理的一致性验证。这项工作代表了朝着用于评估 BHV 的这种 FSI 建模平台的实验验证迈出的一步。