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Transitional and turbulent flow through a simplified medical device model is analyzed as part of the FDA's Critical Path Initiative, designed to improve the process of bringing medical products to market. Computational predictions are often used in the development of devices and reliable in vitro data is needed to validate computational results, particularly estimations of the Reynolds stresses that could play a role in damaging blood elements. The high spatial resolution of laser Doppler velocimetry (LDV) is used to collect two component velocity data within the FDA benchmark nozzle model. Two flow conditions are used to produce flow encompassing laminar, transitional, and turbulent regimes, and viscous stresses, principal Reynolds stresses, and turbulence intensities are calculated from the measured LDV velocities. Axial velocities and viscous stresses are compared to data from a prior inter-laboratory study conducted with particle image velocimetry. Large velocity gradients are observed near the wall in the nozzle throat and in the jet shear layer located in the expansion downstream of the throat, with axial velocity changing as much as 4.5 m/s over 200 μm. Additionally, maximum Reynolds shear stresses of 1000-2000 Pa are calculated in the high shear regions, which are an order of magnitude higher than the peak viscous shear stresses (<100 Pa). It is important to consider the effects of both viscous and turbulent stresses when simulating flow through medical devices. Reynolds stresses above commonly accepted hemolysis thresholds are measured in the nozzle model, indicating that hemolysis may occur under certain flow conditions. As such, the presented turbulence quantities from LDV, which are also available for download at https://fdacfd.nci.nih.gov/ , provide an ideal validation test for computational simulations that seek to characterize the flow field and to predict hemolysis within the FDA nozzle geometry.

Congenital heart disease is the leading cause of infant death in the United States with over 36,000 newborns affected each year. Despite this growing problem there are few mechanical circulatory support devices designed specifically for pediatric and neonate patients. Previous research has been done investigating pediatric ventricular assist devices (PVADs) assuming blood to be a Newtonian fluid in computational fluid dynamics (CFD) simulations, ignoring its viscoelastic and shear-thinning properties. In contrast to adult VADs, PVADs may be more susceptible to hemolysis and thrombosis due to altered flow into the aorta, and therefore, a more accurate blood model should be used. A CFD solver that incorporates a modified Oldroyd-B model designed specifically for pediatric blood is used to investigate important hemodynamic parameters in a pediatric aortic model under pulsatile flow conditions. These results are compared to Newtonian blood simulations at three physiological pediatric hematocrits. Minor differences are seen in both velocity and wall shear stress (WSS) during early stages of the cardiac cycle between the Newtonian and viscoelastic models. During diastole, significant differences are seen in the velocities in the descending aorta (up to 12%) and in the aortic branches (up to 30%) between the two models. Additionally, peak WSS differences are seen between the models throughout the cardiac cycle. At the onset of diastole, peak WSS differences of 43% are seen between the Newtonian and viscoelastic model and between the 20 and 60% hematocrit viscoelastic models at peak systole of 41%.

To investigate the effects of pulsatile and continuous pediatric ventricular assist (PVAD) flow and pediatric blood viscoelasticity on hemodynamics in a pediatric aortic graft model. Hemodynamic parameters of pulsatility, along with velocity and wall shear stress (WSS), are analyzed and compared between Newtonian and viscoelastic blood models at a range of physiological pediatric hematocrits using computational fluid dynamics. Both pulsatile and continuous PVAD flow lead to a decrease in pulsatility (surplus hemodynamic energy, ergs/cm(3)) compared to healthy aortic flow but with continuous PVAD pulsatility up to 2.4 times lower than pulsatile PVAD pulsatility at each aortic outlet. Significant differences are also seen between the two flow modes in velocity and WSS. The higher velocity jet during systole with pulsatile flow leads to higher WSSs at the anastomotic toe and at the aortic branch bifurcations. The lower velocity but continuous flow jet leads to a much different flow field and higher WSSs into diastole. Under a range of physiological pediatric hematocrit (20-60%), both velocity and WSS can vary significantly with the higher hematocrit blood model generally leading to higher peak WSSs but also lower WSSs in regions of flow separation. The large decrease in pulsatility seen from continuous PVAD flow could lead to complications in pediatric vascular development while the high WSSs during peak systole from pulsatile PVAD flow could lead to blood damage. Both flow modes lead to similar regions prone to intimal hyperplasia resulting from low time-averaged WSS and high oscillatory shear index.

Tissue engineered heart valves (TEHVs) that can grow and remodel have the potential to serve as permanent replacements of the current non-viable prosthetic valves particularly for pediatric patients. A major challenge in designing functional TEHVs is to mimic both structural and anisotropic mechanical characteristics of the native valve leaflets. To establish a more biomimetic model of TEHV, we fabricated tri-layered scaffolds by combining electrospinning and microfabrication techniques. These constructs were fabricated by assembling microfabricated poly(glycerol sebacate) (PGS) and fibrous PGS/poly(caprolactone) (PCL) electrospun sheets to develop elastic scaffolds with tunable anisotropic mechanical properties similar to the mechanical characteristics of the native heart valves. The engineered scaffolds supported the growth of valvular interstitial cells (VICs) and mesenchymal stem cells (MSCs) within the 3D structure and promoted the deposition of heart valve extracellular matrix (ECM). MSCs were also organized and aligned along the anisotropic axes of the engineered tri-layered scaffolds. In addition, the fabricated constructs opened and closed properly in an ex vivo model of porcine heart valve leaflet tissue replacement. The engineered tri-layered scaffolds have the potential for successful translation towards TEHV replacements., (Copyright © 2014 Elsevier Ltd. All rights reserved.)

Tissue engineered heart valves (TEHV) can be useful in the repair of congenital or acquired valvular diseases due to their potential for growth and remodeling. The development of biomimetic scaffolds is a major challenge in heart valve tissue engineering. One of the most important structural characteristics of mature heart valve leaflets is their intrinsic anisotropy, which is derived from the microstructure of aligned collagen fibers in the extracellular matrix (ECM). In the present study, a directional electrospinning technique is used to fabricate fibrous poly(glycerol sebacate):poly(caprolactone) (PGS:PCL) scaffolds containing aligned fibers, which resemble native heart valve leaflet ECM networks. In addition, the anisotropic mechanical characteristics of fabricated scaffolds are tuned by changing the ratio of PGS:PCL to mimic the native heart valve's mechanical properties. Primary human valvular interstitial cells (VICs) attach and align along the anisotropic axes of all PGS:PCL scaffolds with various mechanical properties. The cells are also biochemically active in producing heart-valve-associated collagen, vimentin, and smooth muscle actin as determined by gene expression. The fibrous PGS:PCL scaffolds seeded with human VICs mimick the structure and mechanical properties of native valve leaflet tissues and would potentially be suitable for the replacement of heart valves in diverse patient populations., (© 2014 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.)

We compare the velocity and shear obtained from particle image velocimetry (PIV) and computational fluid dynamics (CFD) in a pulsatile ventricular assist device (VAD) to further test our thrombus predictive methodology using microscopy data from an explanted VAD. To mimic physiological conditions in vitro , a mock circulatory loop is used with a blood analog that matched blood's viscoelastic behavior at 40% hematocrit. Under normal physiologic pressures and for a heart rate of 75 bpm, PIV data is acquired and wall shear maps are produced. The resolution of the PIV shear rate calculations are tested using the CFD and found to be in the same range. A bovine study, using a model of the 50 cc Penn State V-2 VAD, for 30 days at a constant beat rate of 75 beats per minute (bpm) provides the microscopic data whereby after the 30 days, the device is explanted and the sac surface analyzed using scanning electron microscopy (SEM) and, after immunofluorescent labeling for platelets and fibrin, confocal microscopy. Areas are examined based on PIV measurements and CFD, with special attention to low shear regions where platelet and fibrin deposition are most likely to occur. Data collected within the outlet port in a direction normal to the front wall of the VAD shows that some regions experience wall shear rates less than 500 s -1 , which increases the likelihood of platelet and fibrin deposition. Despite only one animal study, correlations between PIV, CFD, and in vivo data show promise. Deposition probability is quantified by the thrombus susceptibility potential, a calculation to correlate low shear and time of shear with deposition.

Background and Aim of the Study: One significant problem encountered during surgery to implant mechanical heart valve prostheses is the propensity for thrombus formation near the valve leaflet and housing. This may be caused by the high shear stresses present in the leakage jet flows through small gaps between leaflets and the valve housing during the valve closure phase., Methods: A two-dimensional (2D) study was undertaken to demonstrate that design changes in bileaflet mechanical valves result in notable changes in the flow-induced stresses and prediction of platelet activation. A Cartesian grid technique was used for the 2D simulation of blood flow through two models of bileaflet mechanical valves, and their flow patterns, closure characteristics and platelet activation potential were compared. A local mesh refinement algorithm allowed efficient and fast flow computations with mesh adaptation based on the gradients of the flow field in the gap between the leaflet and housing at the instant of valve closure. Leaflet motion was calculated dynamically, based on the fluid forces acting on it. Platelets were modeled and tracked as point particles by a Lagrangian particle tracking method which incorporated the hemodynamic forces on the particles., Results: A comparison of results showed that the velocity, wall shear stress and simulated platelet activation parameter were lower in the valve model, with a smaller angle of leaflet traverse between the fully open to the fully closed position. The parameters were also affected to a lesser extent by local changes in the leaflet and housing geometry., Conclusion: Computational simulations can be used to examine local design changes to help minimize the fluid-induced stresses that may play a key role in thrombus initiation with the implanted mechanical valves.

Background and Aim of the Study: Mechanical heart valves (MHVs) are known to induce cavitation during closure and rebound. Cavitation may lead to blood element damage and stable bubble formation, with the latter introducing emboli into the cranial circulation and increasing the risk of stroke. Previous research has suggested that CO2 is the primary blood gas involved in stable bubble growth, due to its high solubility compared to that of oxygen or nitrogen. The primary objective of this study is to determine the role that CO2 plays in MHV-induced cavitation bubble formation., Methods: Degassed water (5 ppm) was supplemented with CO2 at partial pressures of 0, 40 and 100 mmHg. Cavitation was visualized using high-speed videography for 29 mm Björk-Shiley Monostrut and Medtronic Hall MHVs in the mitral position. Experimental parameters (heart rate, systolic duration, and left ventricular pressure) were adjusted to provide dp/dt values of 500, 2,500 and 4,500 mmHg/s. High-frequency pressure fluctuations of cavitation bubble collapse were detected using a hydrophone., Results: Root-mean square (RMS) values were calculated to quantify the cavitation intensity for both MHVs at the three loading conditions. The images of cavitation bubble formation and collapse were correlated to their respective RMS values. This study revealed no statistical difference between the cavitation intensities produced by either of the MHVs for the range of CO2-supplemented degassed water tested. For example, at the most physiologic loading condition of 2,500 mmHg/s, the RMS values for the Björk-Shiley Monostrut valve in degassed water containing 0 and 100 mmHg CO2 were 32.7 +/- 3.5 and 34.3 +/- 6.1 mmHg, respectively., Conclusion: The results of this in-vitro study show that, despite affecting stable bubble growth, the presence and quantity of dissolved CO2 does not affect the intensity of the cavitation events occurring during impact of the valve occluder with its housing. Therefore, the role of CO2 is limited to stable bubble development.

Background and Aim of the Study: A sudden pressure drop and recovery can induce cavitation in liquids. Mechanical heart valves (MHVs) generate such a pressure drop at closure, and cavitation generation around MHVs has been demonstrated many times. Cavitation is suspected as being a cause of blood and valve material damage., Methods: In this in-vitro experiment, visual images and acoustic signals associated with MHV cavitation were studied to reveal cavitation characteristics. Björk-Shiley Convex-Concave valves, one with a pyrolytic carbon occluder and one with a Delrin occluder, were installed in a single-shot valve chamber. Cavitation intensity was controlled by load (dP/dt) and air content of water. The acoustic signal was measured using a hydrophone and visual images recorded with a high-speed digital camera system., Results: Cavitation images showed that 10 ppm water rarely developed cavitation, unlike the 16 ppm water. A distinct peak pressure was observed at cavitation collapse that was a good indicator of MHV cavitation intensity. The average of the peak pressures revealed that cavitation intensity increased faster with increasing load for the 16 ppm water., Conclusion: The use of the peak pressure may be the preferred method for correlating cavitation intensity in structures for which the separation of valve closure noise and cavitation signal is difficult, as for the valves studied here.