A number of clinical, in vitro and computational studies have shown the potential for thromboembolic complications in bileaflet mechanical heart valves (BMHV), primarily due to the complex and unsteady flows in the valve hinges. These studies have focused on quantitative and qualitative parameters such as velocity magnitude, turbulent shear stresses, vortex formation and platelet activation to identify potential for blood damage. However, experimental characterization of the whole flow fields within the valve hinges has not yet been conducted. This information can be utilized to investigate instantaneous damage to blood elements and also to validate numerical studies focusing on the hinge’s complex fluid dynamics. The objective of this study was therefore to develop a high-resolution imaging system to characterize the flow fields and global velocity maps in a BMHV hinge. Subsequently, the present study investigated the effect of hinge gap width on flow fields in a St. Jude Medical BMHV. The results from this study suggest that the BMHV hinge design is a delicate balance between reduction of fluid shear stresses and areas of flow stasis during leakage flow, and needs to be optimized to ensure minimal thromboembolic complications. Overall, the current study demonstrates the ability of high-resolution Micro Particle Image Velocimetry to assess the fluid flow fields within the hinges of bileaflet mechanical heart valves, which can be extended to investigate micro-scale flow domains in critical regions of other cardiovascular devices to assess their blood damage potential.

To better understand how platelets behave when exposed to high shear stress, computational fluid dynamic (CFD) models for single-layer (uniform and constant) viscosity flow and two-layer (two distinct regions of different viscosities) viscosity flow were developed. The single-layer model, which represents common standard practice, did not predict the pressure drop correctly; the error produced from using the single-layer model was approximately 95%. However, the two-layer model produced results that were within 6% of the experimental results. Experimental results used to validate CFD models were obtained from data gathered by researchers at University Medical Center (UMC) in Jackson, MS. Using Fluent 6.2, simulations were performed that showed the characteristics of blood flow in a long stenosis. The beginning of the development of a blood damage model was also investigated. This thesis could provide researchers with information that will eventually allow the prediction of platelet activation and hemolysis.

Various congenital heart defects (CHDs) are characterized by the existence of a single functional ventricle, which perfuses both the systemic and pulmonary circulation in parallel. A three-stage palliation procedure, including the final Fontan Completion, is often adopted by surgeons to treat patients with such CHDs. However, the most common outcome of this surgery, an extra-cardiac total cavopulmonary connection (TCPC), formed by suturing the inferior vena cava (IVC) and superior vena cava (SVC) to the pulmonary arteries (PAs), results in non-physiological flow conditions, systemic venous hypertension, reduced cardiac output, and pressure losses, which ultimately calls for a heart transplantation. A modest pressure rise of 5-6 mm Hg would correct the abnormal flow dynamics in these patients. To achieve this, a novel conceptual design of a percutaneous dual propeller pump inserted and mounted inside the TCPC is developed and studied. The designed blood pump is percutaneously inserted via the Femoral vein and deployed at the center of Total Cavopulmonary Connection (TCPC). The two propellers, each placed in the Superior Vena Cava (SVC) and the Inferior Vena Cava (IVC) are connected by a single shaft and motor, and thus rotate at same speed. The device is supported with the help of a self-expanding stent which would be anchored to the walls of the IVC and the SVC. An inverse design methodology implementing Blade Element Momentum theory and Goldstein's radial momentum loss theory was employed to generate the blade profiles for the studied propeller pumps. The propeller blade profiles generated from the inverse design optimization code were examined for hydraulic performance, blood flow pattern and potential for hemolysis inside the TCPC using 3-D computational fluid dynamics (CFD) analysis. The Lagrangian particle tracking approach in conjunction with a non-linear mathematical power law model was used for predicting the blood damage potential of the analysed blood pump designs by calculating the scalar shear stress history sustained by the red blood cells (RBC). The study demonstrated that the IVC and SVC propeller pumps could provide a pressure rise of 1-20 mm Hg at flow rates ranging from 0.5 to 5 lpm while rotating at speeds of 6,000-12,000 rpm. Moreover, the average Blood Damage Index (BDI), quantifying the level of blood trauma sustained by the RBCs for the analyzed propeller pump designs, was found to be around 3e-04% to 4e-04% which is within the acceptable limits for an axial flow heart assist device. Thus, such a dual propeller blood pump configuration could potentially provide assistance to Fontan patients by unloading the single functional ventricle thereby acting as a bridge to transplantation and recovery until a donor heart is available. / Master of Science / A single functional ventricle is a type of congenital heart defect, where either left or right ventricle is underdeveloped, resulting in a single ventricular chamber to pump blood to both the body as well as lungs. A three-stage surgical procedure called the Fontan procedure, is often adopted by the surgeons to treat this defect by disconnecting the inferior(IVC) and superior vena cava(SVC), the two main veins carrying de-oxygenated blood from the body to the heart, and connecting them to the pulmonary arteries(PAs), the vessels carrying de-oxygenated blood from heart to the lungs. This helps to bypass the underdeveloped ventricle and allows blood to flow directly from the body to the lungs. However, the absence of a pumping chamber in the newly developed blood portal system causes an increase in pressure inside the vena cava and pressure losses inside the pulmonary arteries, which results in vena cava hypertension, reduced cardiac output. A modest pressure rise of 5-6 mm Hg across the vena cava or pulmonary artery should correct the abnormal flow dynamics and should bring the cardiac output of such patients back to normal. To achieve this, a conceptual design of a dual propeller mechanical circulatory support device has been designed and developed in this thesis.

Bileaflet mechanical heart valves (BMHVs), though a life-saving tool in treating heart valve disease, are often associated with serious complications, including a high risk of hemolysis, platelet activation, and thromboembolism. One likely cause of this hyper-coagulative state is the nonphysiologic levels of stress experienced by the erythrocytes and platelets flowing through the BMHVs. Research has shown that the combination of shear stress magnitude and exposure time found in the highly transient leakage jet emanating from the b-datum gap during valve closure is sufficient to cause hemolysis and platelet activation. Regions of flow stasis in the valve vicinity may also allow activated platelets to aggregate and form thrombus. This thesis addresses the hypothesis that passive flow control may have the potential to reduce flow-induced thrombogenicity by altering the fluid mechanics of bileaflet mechanical heart valves. To test this hypothesis, a steady model of the regurgitant b-datum line jet was developed and studied. This model served as a test bed for various vortex generator array designs. The fluid mechanics of the b-datum line jet model was investigated with flow visualization and particle image velocimetry. In vitro tests with whole human blood were performed with and without the vortex generators in order to determine how the presence of the passive flow control affected the propensity of the blood to form thrombus. An effort was then made to correlate the fluid mechanics of the jet model with the procoagulant potential results from the blood experiments. The effect of the vortex generators on the fluid mechanics of the valve under physiologic pulsatile conditions was also investigated via flow visualization in the Georgia Tech Left Heart Simulator. By studying a steady model of the regurgitant b-datum line jet, it was found, using an in vitro system with whole human blood, that the presence of vortex generators significantly decreased the blood's propensity for thrombus formation. The potential of applying passive flow control to cardiovascular hardware in order to mitigate the injurious effects of shear-induced platelet activation is thus demonstrated. The investigation into the effect of vortex generators on the fluid mechanics of the b-datum line jet showed that the jet oscillated aperiodically and that the effect of the applied flow control was played out at both the scale of the chamber (large-scale) and on the scale of the vortex generator fins (small-scale). On the large scale, the presence of vortex generators appeared to decrease the magnitude or frequency of jet oscillation, thereby stabilizing the jet. After removing the effect of the large-scale oscillations via phase averaging, the effect of the vortex generators on the small scale was examined. On the small scale, the jet without flow control was found to have higher levels of velocity RMS, particularly on the jet periphery, and higher levels of Reynolds shear stress. It is proposed that the vortex generators effect this change by generating vorticity in the plane of the jet. This vorticity is theorized to stabilize the jet, delaying roll-up of the jet shear layer which occurs via the Kelvin-Helmholtz instability. The method by which the vortex generators acted on the fluid mechanics of the steady jet system to decrease the blood's procoagulant potential was investigated via flow visualization and DPIV. The results from these studies implicate two possible mechanisms by which the vortex generators may act. First, the peak turbulent shear stresses in the jet were reduced by 10-20% with the application of vortex generators. Even if only a few platelets were activated in each passage through the valve, the cumulative effect of this difference in peak stresses after many passes would be greatly magnified. Thus, this reduction in turbulent shear stresses may be sufficient to explain the change seen in the blood's procoagulant potential with the application of passive flow control. It is suspected, though, that the second mechanism is dominant. The flow fields revealed that the presence of the vortex generators delayed or prevented the roll-up of the Kelvin-Helmholtz instability in the b-datum jet's shear layers into discrete vortices. By doing so, it is thought that opportunities for the interaction of activated and unactivated platelets entrained in these vortices were prevented, thereby inhibiting further propagation of the coagulation cascade. Even if the rate at which platelets were activated was similar for cases with and without flow control, it seems that the flow fields experienced by the platelets subsequent to activation can determine the level of procoagulant potential. Under the steady conditions observed in this experiment, the jet influenced by vortex generators was thus shown to induce significantly lower levels of procoagulant potential.

Defective or diseased native valves have been replaced by bileaflet mechanical heart valves (BMHVs) for many years. However, severe complications still exist, and thus blood damage that occurs in BMHV flows must be well understood. The aim of this research is to numerically study platelet damage that occurs in BMHV flows. The numerical suspension flow method combines lattice-Boltzmann fluid modeling with the external boundary force method. This method is validated as a general suspension flow solver, and then validated against experimental BMHV flow data. Blood damage is evaluated for a physiologic adult case of BMHV flow and then for BMHVs with pediatric sizing and flow conditions. Simulations reveal intricate, small-scale BMHV flow features, and the presence of turbulence in BMHV flow. The results suggest a shift from previous evaluations of instantaneous flow to the determination of long-term flow recirculation regions when assessing thromboembolic potential. Sharp geometries that may induce these recirculation regions should be avoided in device design. Simulations for predictive assessment of pediatric sized valves show increased platelet damage values for potential pediatric valves. However, damage values do not exceed platelet activation thresholds, and highly damaged platelets are found far from the valve. Thus, the increased damage associated with resized valves is not such that pediatric valve development should be hindered. This method can also be used as a generic tool for future evaluation of novel prosthetic devices or cardiovascular flow problems.

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