Barbaro V, Grigioni M, Daniele C, D'Avenio G, Boccanera G
Laboratory of Biomedical Engineering, Istituto Superiore di Sanità, Rome, Italy.
Int J Artif Organs. 1997 Nov;20(11):622-8.
The investigation of the flow field downstream of a cardiac valve prosthesis is a well established task. In particular turbulence generation is of interest if damage to blood constituents is to be assessed. Several prosthetic valve flow studies are available in literature but they generally concern large-sized prostheses. The FDA draft guidance requires the study of the maximum Reynolds number conditions for a cardiac valve model to assess the worst case in turbulence by choosing both the minimum valve diameter and a high cardiac output value as protocol set up. Within the framework of a national research project regarding the characterization of cardiovascular endoprostheses, the Laboratory of Biomedical Engineering is currently conducting an in-depth study of turbulence generated downstream of bileaflet cardiac valves. Four models of 19 mm sized bileaflet valve prostheses, namely St Jude Medical HP Edwards Tekna, Sorin Bicarbon, and CarboMedics, were studied in aortic position. The prostheses were selected for the nominal annulus diameter reported by the manufacturers without any assessment of the valve sizing method. The hemodynamic function was investigated using a bidimensional LDA system. Results concern velocity profiles during the peak flow systolic phase, at high cardiac output regime, highlighting the different flow field features downstream of the four small-sized cardiac valves.
对心脏瓣膜假体下游流场的研究是一项成熟的任务。特别是如果要评估对血液成分的损害,湍流的产生就会受到关注。文献中有几项人工瓣膜流动研究,但它们通常涉及大型假体。美国食品药品监督管理局(FDA)的指导草案要求研究心脏瓣膜模型的最大雷诺数条件,通过选择最小瓣膜直径和高心输出量值作为方案设置来评估湍流的最坏情况。在一个关于心血管内假体表征的国家研究项目框架内,生物医学工程实验室目前正在深入研究双叶心脏瓣膜下游产生的湍流。研究了四种19毫米尺寸的双叶瓣膜假体模型,即圣犹达医疗公司的HP Edwards Tekna、索林双叶瓣、索林碳酸氢盐瓣和卡波医学瓣,它们处于主动脉位置。这些假体是根据制造商报告的标称瓣环直径选择的,没有对瓣膜尺寸确定方法进行任何评估。使用二维激光多普勒测速(LDA)系统研究了血液动力学功能。结果涉及高心输出量状态下收缩期峰值血流时的速度剖面,突出了四种小型心脏瓣膜下游不同的流场特征。