Examining the universality of the hemolysis power law model from simulations of the FDA nozzle using calibrated model coefficients.

Examining the universality of the hemolysis power law model from simulations of the FDA nozzle using calibrated model coefficients.
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DOI:
10.1007/s10237-022-01655-5
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发表时间:
2023-04
影响因子:
3.5
通讯作者:
Craven, Brent A.
Craven, Brent A.
中科院分区:
工程技术2区
文献类型:
--
作者:
Mantegazza, Alberto;Tobin, Nicolas;Manning, Keefe B.;Craven, Brent A.

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计算流体动力学(CFD)被广泛应用于预测医疗设备的机械溶血。最流行的溶血模型是基于压力的幂律模型,该模型基于血红蛋白从红细胞(rbc)释放与血流诱导的压力大小和暴露时间之间的经验相关性。经验系数传统上是使用简化的库埃式血液剪切装置的实验数据来校准的,该装置具有均匀剪切层流和明确的暴露时间。在具有复杂血流动力学的真实医疗设备的模拟中使用这种理想化系数被认为是使用幂律模型进行绝对溶血预测的历史不准确性的主要原因。Craven等人(Biomech Model Mechanobiol, 2018:1005 - 1030,2019)最近开发了一种基于cfd的Kriging代理建模方法,用于校准真实设备中的经验系数,该方法可能用于更准确地预测绝对溶血。在本研究中,我们使用FDA基准喷嘴来研究使用这些校准系数是否可以提高标准欧拉幂律模型的预测精度。我们首先通过与颗粒图像测速测量结果的比较来证明我们的CFD流动模拟的可靠性。然后我们进行溶血模拟,并将结果与体外实验进行比较。重要的是,模拟使用了牛红细胞悬浮液通过小毛细管流动的校准系数,这与通过FDA喷嘴的牛血液流动相对可比。结果表明,CFD对FDA喷嘴内相对溶血的预测是相当准确的。然而,绝对预测是高度不准确的,尽管使用了相对相似几何形状的校准模型系数,但与实验相比,来自CFD的修正溶血值指数的误差大约为三个数量级。我们严格检查不准确的原因,包括在每个设备的溶血区域的流动条件的差异和溶血幂律模型完全是经验缺乏普遍性。因此,虽然预测相对溶血的能力对产品开发很有价值,但在依靠幂律模型准确预测医疗设备的绝对溶血潜能之前,还需要进一步改进。
Computational fluid dynamics (CFD) is widely used to predict mechanical hemolysis in medical devices. The most popular hemolysis model is the stress-based power law model that is based on an empirical correlation between hemoglobin release from red blood cells (RBCs) and the magnitude of flow-induced stress and exposure time. Empirical coefficients are traditionally calibrated using data from experiments in simplified Couette-type blood-shearing devices with uniform-shear laminar flow and well-defined exposure times. Use of such idealized coefficients in simulations of real medical devices with complex hemodynamics is thought to be a primary reason for the historical inaccuracy of absolute hemolysis predictions using the power law model. Craven et al. (Biomech Model Mechanobiol 18:1005–1030, 2019) recently developed a CFD-based Kriging surrogate modeling approach for calibrating empirical coefficients in real devices that could potentially be used to more accurately predict absolute hemolysis. In this study, we use the FDA benchmark nozzle to investigate whether utilizing such calibrated coefficients improves the predictive accuracy of the standard Eulerian power law model. We first demonstrate the credibility of our CFD flow simulations by comparing with particle image velocimetry measurements. We then perform hemolysis simulations and compare the results with in vitro experiments. Importantly, the simulations use coefficients calibrated for the flow of a suspension of bovine RBCs through a small capillary tube, which is relatively comparable to the flow of bovine blood through the FDA nozzle. The results show that the CFD predictions of relative hemolysis in the FDA nozzle are reasonably accurate. The absolute predictions are, however, highly inaccurate with modified index of hemolysis values from CFD in error by roughly three orders of magnitude compared with the experiments, despite using calibrated model coefficients from a relatively similar geometry. We rigorously examine the reasons for the inaccuracy that include differences in the flow conditions in the hemolytic regions of each device and the lack of universality of the hemolysis power law model that is entirely empirical. Thus, while the capability to predict relative hemolysis is valuable for product development, further improvements are needed before the power law model can be relied upon to accurately predict the absolute hemolytic potential of a medical device.
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