Design Concepts and Preclinical Results of a Miniaturized HeartWare Platform: The MVAD System.

OBJECTIVE: Ventricular assist device (VAD) miniaturization is one design trend that may result in less-invasive implantation techniques and more versatility with patient selection. The MVAD System is a miniature, continuous-flow device implanted in the ventricle. The pump is capable of delivering between 0 and 7 L/min of flow at a mean arterial pressure of 75 mm Hg. The impeller was optimized from its original design to improve hydraulic performance, minimize shear regions, and enhance the impeller's radial stiffness. These studies evaluated the MVAD System with modified impeller in the preclinical setting. METHODS: This modified pump design was tested through chronic studies (n = 6) in a healthy ovine model where 4 animals were implanted for a duration of 30 ± 5 days and 2 animals were implanted for a duration of 90 ± 5 days. The pump was placed in the left ventricular apex with the outflow graft anastomosed to the descending aorta. Postoperatively, no anticoagulant or antiplatelet therapies were administered throughout the study duration. RESULTS: All 6 animals reached their elective date of kill, demonstrating no evidence of organ compromise or device-related complications. Average pump parameters did not deviate significantly, and average rotational speed, pump flow, and power consumption were 14095 ± 139 RPM, 4.1 ± 0.4 L/min, and 4.3 ± 0.1 W, respectively. Examination of pump components postexplant demonstrated no mechanical wear or thrombus formation. CONCLUSIONS: Hemocompatibility and biocompatibility of the modified MVAD System were demonstrated through pump parameters, blood chemistry panels, and histopathology analysis.

Computational study of the blood flow in three types of 3D hollow fiber membrane bundles.

The goal of this study is to develop a computational fluid dynamics (CFD) modeling approach to better estimate the blood flow dynamics in the bundles of the hollow fiber membrane based medical devices (i.e., blood oxygenators, artificial lungs, and hemodialyzers). Three representative types of arrays, square, diagonal, and random with the porosity value of 0.55, were studied. In addition, a 3D array with the same porosity was studied. The flow fields between the individual fibers in these arrays at selected Reynolds numbers (Re) were simulated with CFD modeling. Hemolysis is not significant in the fiber bundles but the platelet activation may be essential. For each type of array, the average wall shear stress is linearly proportional to the Re. For the same Re but different arrays, the average wall shear stress also exhibits a linear dependency on the pressure difference across arrays, while Darcy's law prescribes a power-law relationship, therefore, underestimating the shear stress level. For the same Re, the average wall shear stress of the diagonal array is approximately 3.1, 1.8, and 2.0 times larger than that of the square, random, and 3D arrays, respectively. A coefficient C is suggested to correlate the CFD predicted data with the analytical solution, and C is 1.16, 1.51, and 2.05 for the square, random, and diagonal arrays in this paper, respectively. It is worth noting that C is strongly dependent on the array geometrical properties, whereas it is weakly dependent on the flow field. Additionally, the 3D fiber bundle simulation results show that the three-dimensional effect is not negligible. Specifically, velocity and shear stress distribution can vary significantly along the fiber axial direction.

A quantitative comparison of mechanical blood damage parameters in rotary ventricular assist devices: shear stress, exposure time and hemolysis index.

Ventricular assist devices (VADs) have already helped many patients with heart failure but have the potential to assist more patients if current problems with blood damage (hemolysis, platelet activation, thrombosis and emboli, and destruction of the von Willebrand factor (vWf)) can be eliminated. A step towards this goal is better understanding of the relationships between shear stress, exposure time, and blood damage and, from there, the development of numerical models for the different types of blood damage to enable the design of improved VADs. In this study, computational fluid dynamics (CFD) was used to calculate the hemodynamics in three clinical VADs and two investigational VADs and the shear stress, residence time, and hemolysis were investigated. A new scalar transport model for hemolysis was developed. The results were compared with in vitro measurements of the pressure head in each VAD and the hemolysis index in two VADs. A comparative analysis of the blood damage related fluid dynamic parameters and hemolysis index was performed among the VADs. Compared to the centrifugal VADs, the axial VADs had: higher mean scalar shear stress (sss); a wider range of sss, with larger maxima and larger percentage volumes at both low and high sss; and longer residence times at very high sss. The hemolysis predictions were in agreement with the experiments and showed that the axial VADs had a higher hemolysis index. The increased hemolysis in axial VADs compared to centrifugal VADs is a direct result of their higher shear stresses and longer residence times. Since platelet activation and destruction of the vWf also require high shear stresses, the flow conditions inside axial VADs are likely to result in more of these types of blood damage compared with centrifugal VADs.

Evaluation of Eulerian and Lagrangian models for hemolysis estimation.

Hemolysis caused by flow-induced mechanical damage to red blood cells is still a problem in medical devices such as ventricular assist devices (VADs), artificial lungs, and mechanical heart valves. A number of different models have been proposed by different research groups for calculating the hemolysis, and of these, the power law-based models (HI(%)=Ct(α)τ(ß)) have proved the most popular because of their ease of use and applicability to a wide range of devices. However, within this power law category of models there are a number of different implementations. The aim of this work was to evaluate different power law-based models by calculating hemolysis in a specifically designed shearing device and a clinical VAD, and comparing the estimated results with experimental measurements of the hemolysis in these two devices. Both the Eulerian scalar transport and all the Lagrangian models had fairly large percentage of errors compared with the experiments (minimum Eulerian 91% and minimum Lagrangian 57%) showing they could not accurately predict the magnitude of the hemolysis. However, the Eulerian approach had large correlation coefficients (>0.99) showing that this method can predict relative hemolysis, which would be useful in comparative analysis, for example, for ranking different devices or for design optimization studies.

Computational model-based design of a wearable artificial pump-lung for cardiopulmonary/respiratory support.

Mechanical ventilation and extracorporeal membrane oxygenation are the only immediate options available for patients with respiratory failure. However, these options present significant shortcomings. To address this unmet need for respiratory support, innovative respiratory assist devices are being developed. In this study, we present the computational model-based design, and analysis of functional characteristics and hemocompatibility performance, of an innovative wearable artificial pump-lung (APL) for ambulatory respiratory support. Computer-aided design and computational fluid dynamics (CFD)-based modeling were utilized to generate the geometrical model and to acquire the fluid flow field, gas transfer, and blood damage potential. With the knowledge of flow field, gas transfer, and blood damage potential through the whole device, design parameters were adjusted to achieve the desired specifications based on the concept of virtual prototyping using the computational modeling in conjunction with consideration of the constraints on fabrication processes and materials. Based on the results of the CFD design and analysis, the physical model of the wearable APL was fabricated. Computationally predicted hydrodynamic pumping function, gas transfer, and blood damage potential were compared with experimental data from in vitro evaluation of the wearable APL. The hydrodynamic performance, oxygen transfer, and blood damage potential predicted with computational modeling, along with the in vitro experimental data, indicated that this APL meets the design specifications for respiratory support with excellent biocompatibility at the targeted operating condition.

Study of flow-induced hemolysis using novel Couette-type blood-shearing devices.

To assist the development and application of blood-contacting medical devices, two novel flow-through Couette-type blood-shearing devices have been developed to study the quantitative relationship between blood damage indexes and flow-dependent parameters. One device is an axial flow-through Couette-type device supported by a pair of pin bearings adapted from the adult Jarvik 2000 blood pump. The other is a centrifugal flow-through Couette-type device supported with magnetic bearings adapted from the CentriMag blood pump. In both devices, a rotor spindle was used to replace the original impeller blades so that a small gap was created between the housing and the rotating spindle surface. Computational fluid dynamics simulations have shown that a uniform, high shear stress region can be generated inside the small gap while the shear stresses elsewhere are relatively low. The possibility of secondary blood damage caused by mechanical seals was eliminated due to the use of a magnetic rotor system. Blood flow through the gap was driven by an externally pressurized reservoir. By adjusting the rotational speed and blood flow rate, shear-induced hemolysis was quantified at a matrix of exposure time (0.039 to 1.48 s) and shear stress (50 to 320 Pa). All of the experiments were conducted at room temperature using heparinized ovine blood with a hematocrit value of 30%. The measured hemolysis levels were much lower than those published in the literature, and the overestimation of those earlier studies may be attributable to device-related secondary blood-damaging effects. A new set of coefficients for the power law model was derived from the regression of the experimental data.

The use of computational fluid dynamics in the development of ventricular assist devices.

Progress in the field of prosthetic cardiovascular devices has significantly contributed to the rapid advancements in cardiac therapy during the last four decades. The concept of mechanical circulatory assistance was established with the first successful clinical use of heart-lung machines for cardiopulmonary bypass. Since then a variety of devices have been developed to replace or assist diseased components of the cardiovascular system. Ventricular assist devices (VADs) are basically mechanical pumps designed to augment or replace the function of one or more chambers of the failing heart. Computational Fluid Dynamics (CFD) is an attractive tool in the development process of VADs, allowing numerous different designs to be characterized for their functional performance virtually, for a wide range of operating conditions, without the physical device being fabricated. However, VADs operate in a flow regime which is traditionally difficult to simulate; the transitional region at the boundary of laminar and turbulent flow. Hence different methods have been used and the best approach is debatable. In addition to these fundamental fluid dynamic issues, blood consists of biological cells. Device-induced biological complications are a serious consequence of VAD use. The complications include blood damage (haemolysis, blood cell activation), thrombosis and emboli. Patients are required to take anticoagulation medication constantly which may cause bleeding. Despite many efforts blood damage models have still not been implemented satisfactorily into numerical analysis of VADs, which severely undermines the full potential of CFD. This paper reviews the current state of the art CFD for analysis of blood pumps, including a practical critical review of the studies to date, which should help device designers choose the most appropriate methods; a summary of blood damage models and the difficulties in implementing them into CFD; and current gaps in knowledge and areas for future work.

Computational Fluid Dynamics and Experimental Characterization of the Pediatric Pump-Lung.

The pediatric pump-lung (PediPL) is a miniaturized integrated pediatric pump-oxygenator specifically designed for cardiac or cardiopulmonary support for patients weighing 5-20 kg to allow mobility and extended use for 30 days. The PediPL incorporates a magnetically levitated impeller with uniquely configured hollow fiber membranes into a single unit capable of performing both pumping and gas exchange. A combined computational and experimental study was conducted to characterize the functional and hemocompatibility performances of this newly developed device. The three-dimensional flow features of the PediPL and its hemolytic characteristics were analyzed using computational fluid dynamics based modeling. The oxygen exchange was modeled based on a convection-diffusion-reaction process. The hollow fiber membranes were modeled as a porous medium which incorporates the flow resistance in the bundle by an added momentum sink term. The pumping function was evaluated for the required range of operating conditions (0.5-2.5 L/min and 1000-3000 rpm). The blood damage potentials were further analyzed in terms of flow and shear stress fields, and the calculations of hemolysis index. In parallel, the hydraulic pump performance, oxygen transfer and hemolysis level were quantified experimentally. Based on the computational and experimental results, the PediPL device is found to be functional to provide necessary oxygen transfer and blood pumping requirements for the pediatric patients. Smooth blood flow characteristics and low blood damage potential were observed in the entire device. The in-vitro tests further confirmed that the PediPL can provide adequate blood pumping and oxygen transfer over the range of intended operating conditions with acceptable hemolytic performance. The rated flow rate for oxygenation is 2.5 L/min. The normalized index of hemolysis is 0.065 g/100L at 1.0 L/min and 3000 rpm.

Micro-scale Modeling of Flow and Oxygen Transfer in Hollow Fiber Membrane Bundle.

The aim of this work was to develop a modeling approach to solve the flow and oxygen transfer when the blood passes through the hollow-fiber membrane bundle. For this purpose, a "two-region" modeling approach was developed regarding the hollow fiber and blood regions. The oxygen transfer in these regions was defined with separate diffusion processes. Two dimensional single and multi-fiber geometries were created and flow solutions were obtained for a non-Newtonian fluid. The convection-diffusion-reaction equation was solved to produce the oxygen partial pressure distributions. As a benefit of coupling the interstitial flow field into the oxygen transfer through the hollow-fiber membrane bundle, the membrane resistance was taken into consideration. Thus, varying oxygen partial pressures were observed on the outer fiber surface, which is contrary to the common simplifying assumptions of negligible membrane resistance and uniform oxygen content on the fiber surface (Traditional approach). It was illustrated that, the current approach can be utilized to predict the mass transfer efficiencies without overestimating as compared to the predictions obtained with the traditional approach. Utilization of the current approach was found to be beneficial for the geometries with lower packing density which allows significant P(O2) variations on the fiber surfaces. For the geometries with dense packings, the above simplifying assumptions could be applicable. The model predictions were validated with the experimental measurements taken from a benchmark device.

Computational characterization of flow and hemolytic performance of the UltraMag blood pump for circulatory support.

The Levitronix UltraMag blood pump is a next generation, magnetically suspended centrifugal pump and is designed to provide circulatory support for pediatric and adult patients. The aim of this study is to investigate the hemodynamic and hemolytic characteristics of this pump using the computational fluid dynamics (CFD) approach. The computational domain for CFD analysis was constructed from the three-dimensional geometry (3D) of the UltraMag blood pump and meshed into 3D tetrahedral/hybrid elements. The governing equations of fluid flow were computationally solved to obtain a blood flow through the blood pump. Further, hemolytic blood damage was calculated by solving a scalar transport equation where the scalar variable and the source term were obtained utilizing an empirical power-law correlation between the fluid dynamic variables and hemolysis. To obtain mesh independent flow solution, a comparative examination of vector fields, hydrodynamic performance, and hemolysis predictions were carried out. Different sizes of tetrahedral and tetrahedral/hexahedral mixed hybrid models were considered. The mesh independent solutions were obtained by a hybrid model. Laminar and SST κ-ω turbulence flow models were used for different operating conditions. In order to pinpoint the most significant hemolytic region, the flow field analysis was coupled to the hemolysis predictions. In summary, computational characterization of the device was satisfactorily carried out within the targeted operating conditions of the device, and it was observed that the UltraMag blood pump can be safely operated for its intended use to create a circulatory support for both pediatric and adult-sized patients.

Computational fluid dynamics analysis of thrombosis potential in left ventricular assist device drainage cannulae.

Cannulation is necessary when blood is removed from the body, for example in hemodialysis, cardiopulmonary bypass, blood oxygenators, and ventricular assist devices. Artificial blood contacting surfaces are prone to thrombosis, especially in the presence of stagnant or recirculating flow. In this work, computational fluid dynamics was used to investigate the blood flow fields in three clinically available cannulae (Medtronic DLP 12, 16, and 24 F), used as drainage for pediatric circulatory support and to calculate parameters that may be indicative of thrombosis potential. The results show that using the 24 F cannula below flow rates of about 0.75 L/min produces hemodynamic conditions, which may increase the risk of blood clotting within the cannula. No reasons are indicated for not using the 12 or 16 F cannulae with flow rates between 0.25 and 3.0 L/min.

Computational design and in vitro characterization of an integrated maglev pump-oxygenator.

For the need for respiratory support for patients with acute or chronic lung diseases to be addressed, a novel integrated maglev pump-oxygenator (IMPO) is being developed as a respiratory assist device. IMPO was conceptualized to combine a magnetically levitated pump/rotor with uniquely configured hollow fiber membranes to create an assembly-free, ultracompact system. IMPO is a self-contained blood pump and oxygenator assembly to enable rapid deployment for patients requiring respiratory support or circulatory support. In this study, computational fluid dynamics (CFD) and computer-aided design were conducted to design and optimize the hemodynamics, gas transfer, and hemocompatibility performances of this novel device. In parallel, in vitro experiments including hydrodynamic, gas transfer, and hemolysis measurements were conducted to evaluate the performance of IMPO. Computational results from CFD analysis were compared with experimental data collected from in vitro evaluation of the IMPO. The CFD simulation demonstrated a well-behaved and streamlined flow field in the main components of this device. The results of hydrodynamic performance, oxygen transfer, and hemolysis predicted by computational simulation, along with the in vitro experimental data, indicate that this pump-lung device can provide the total respiratory need of an adult with lung failure, with a low hemolysis rate at the targeted operating condition. These detailed CFD designs and analyses can provide valuable guidance for further optimization of this IMPO for long-term use.