Investigation of the flow performance of a nutating blood pump by computational fluid dynamics

In centrifugal blood pumps, blood is moved into a circular path with the help of an impeller. In a nutating pump, the nutating body takes over the role of the impeller. Since the nutating body itself does not rotate, this pump needs no seal, no blood contacting, and no magnetic bearings. To examine the suitability of the nutating pump principle for mechanical heart assist, the flow performance of different nutating pump models was investigated by computational fluid dynamics. The geometrical parameters of the pump were varied and flow-pressure curves were calculated for 12 models at different rotation frequencies. All models showed satisfactory flow-pressure curves. One model was computed minutely at 1 flow configuration to examine shear stresses within the fluid. A flow of 5 L/min and a frequency of 3,300 rotations per min (rpm) resulted in a differential pressure of 85 mm Hg. The maximum shear stress in the fluid at this flow was estimated to be 193 Pa which is considered to be an acceptable value for a blood pump.     

Fluid force predictions and experimental measurements for a magnetically levitated pediatric ventricular assist device

The latest generation of artificial blood pumps incorporates the use of magnetic bearings to levitate the rotating component of the pump, the impeller. A magnetic suspension prevents the rotating impeller from contacting the internal surfaces of the pump and reduces regions of stagnant and high shear flow that surround fluid or mechanical bearings. Applying this third-generation technology, the Virginia Artificial Heart Institute has developed a ventricular assist device (VAD) to support infants and children. In consideration of the suspension design, the axial and radial fluid forces exerted on the rotor of the pediatric VAD were estimated using computational fluid dynamics (CFD) such that fluid perturbations would be counterbalanced. In addition, a prototype was built for experimental measurements of the axial fluid forces and estimations of the radial fluid forces during operation using a blood analog mixture. The axial fluid forces for a centered impeller position were found to range from 0.5 +/- 0.01 to 1 +/- 0.02 N in magnitude for 0.5 +/- 0.095 to 3.5 +/- 0.164 Lpm over rotational speeds of 6110 +/- 0.39 to 8030 +/- 0.57% rpm. The CFD predictions for the axial forces deviated from the experimental data by approximately 8.5% with a maximum difference of 18% at higher flow rates. Similarly for the off-centered impeller conditions, the maximum radial fluid force along the y-axis was found to be -0.57 +/- 0.17 N. The maximum cross-coupling force in the x direction was found to be larger with a maximum value of 0.74 +/- 0.22 N. This resulted in a 25-35% overestimate of the radial fluid force as compared to the CFD predictions; this overestimation will lead to a far more robust magnetic suspension design. The axial and radial forces estimated from the computational results are well within a range over which a compact magnetic suspension can compensate for flow perturbations. This study also serves as an effective and novel design methodology for blood pump developers employing magnetic suspensions. Following a final design evaluation, a magnetically suspended pediatric VAD will be constructed for extensive hydraulic and animal testing as well as additional validation of this design methodology.     

Dynamic characteristics of a magnetically levitated impeller in a centrifugal blood pump

Centrifugal blood pumps that employ hybrid active/passive magnetic bearings to support noncontact impellers have been developed in order to reduce bearing wear, pump size, the power consumption of the active magnetic bearing, and blood trauma. However, estimates made at the design stage of the vibration of the impeller in the direction of passive suspension during pump operation were inaccurate, because the influence of both the pumping fluid and the rotation of the impeller on the dynamic characteristics was not fully recognized. The purpose of this study is to investigate the dynamic characteristics in a fluid of a magnetically levitated rotating impeller by measuring both the frequency response to sinusoidal excitation of the housing over a wide frequency range and the displacement due to input of a pulsatile flow during left ventricular (LV) assist. The excitation tests were conducted under conditions in which the impeller was levitated in either air or water, and with or without rotation. The experimental and analytical results indicate that vibration of the impeller due to the external force in water was decreased, compared with that in air due to the hydraulic force of water. The axial resonant frequency rose quadratically with rotational speed, and the tilt mode had two resonant frequencies while rotating due to the gyroscopic effect. With the pump inserted into a mock systemic circulatory loop, the dynamic stability of the impeller when pulsatile pressure was applied during LV assist was verified experimentally. The amplitudes of vibration in response to the pulsatile flow in the passively constrained directions were considerably smaller in size than the dimensions of initial gaps between the impeller and the pump housing.     

Evaluation of hydraulic radial forces on the impeller by the volute in a centrifugal rotary blood pump

In many state-of-the-art rotary blood pumps for long-term ventricular assistance, the impeller is suspended within the casing by magnetic or hydrodynamic means. For the design of such suspension systems, profound knowledge of the acting forces on the impeller is crucial. Hydrodynamic bearings running at low clearance gaps can yield increased blood damage and magnetic bearings counteracting high forces consume excessive power. Most current rotary blood pump devices with contactless bearings are centrifugal pumps that incorporate a radial diffuser volute where hydraulic forces on the impeller develop. The yielding radial forces are highly dependent on impeller design, operating point and volute design. There are three basic types of volute design--singular, circular, and double volute. In this study, the hydraulic radial forces on the impeller created by the volute in an investigational centrifugal blood pump are evaluated and discussed with regard to the choice of contactless suspension systems. Each volute type was tested experimentally in a centrifugal pump test setup at various rotational speeds and flow rates. For the pump's design point at 5 L/min and 2500 rpm, the single volute had the lowest radial force (～0 N), the circular volute yielded the highest force (～2 N), and the double volute possessed a force of approx. 0.5 N. Results of radial force magnitude and direction were obtained and compared with a previously performed computational fluid dynamics (CFD) study.     

Evaluation of the impeller shroud performance of an axial flow ventricular assist device using computational fluid dynamics

Generally, there are two types of impeller design used in the axial flow blood pumps. For the first type, which can be found in most of the axial flow blood pumps, the magnet is embedded inside the impeller hub or blades. For the second type, the magnet is embedded inside the cylindrical impeller shroud, and this design has not only increased the rotating stability of the impeller but has also avoided the flow interaction between the impeller blade tip and the pump casing. Although the axial flow blood pumps with either impeller design have been studied individually, the comparisons between these two designs have not been conducted in the literature. Therefore, in this study, two axial flow blood pumps with and without impeller shrouds were numerically simulated with computational fluid dynamics and compared with each other in terms of hydraulic and hematologic performances. For the ease of comparison, these two models have the same inner components, which include a three-blade straightener, a two-blade impeller, and a three-blade diffuser. The simulation results showed that the model with impeller shroud had a lower static pressure head with a lower hydraulic efficiency than its counterpart. It was also found that the blood had a high possibility to deposit on the impeller shroud inner surface, which greatly enhanced the possibility of thrombus formation. The blood damage indices in both models were around 1%, which was much lower than the 13.1% of the axial flow blood pump of Yano et al. with the corresponding experimental hemolysis of 0.033 g/100 L.     

A hydrodynamically suspended, magnetically sealed mechanically noncontact axial flow blood pump: design of a hydrodynamic bearing

To overcome the drive shaft seal and bearing problem in rotary blood pumps, a hydrodynamic bearing, a magnetic fluid seal, and a brushless direct current (DC) motor were employed in an axial flow pump. This enabled contact-free rotation of the impeller without material wear. The axial flow pump consisted of a brushless DC motor, an impeller, and a guide vane. The motor rotor was directly connected to the impeller by a motor shaft. A hydrodynamic bearing was installed on the motor shaft. The motor and the hydrodynamic bearing were housed in a cylindrical casing and were waterproofed by a magnetic fluid seal, a mechanically noncontact seal. Impeller shaft displacement was measured using a laser sensor. Axial and radial displacements of the shaft were only a few micrometers for motor speed up to 8500 rpm. The shaft did not make contact with the bearing housing. A flow of 5 L/min was obtained at 8000 rpm at a pressure difference of 100 mm Hg. In conclusion, the axial flow blood pump consisting of a hydrodynamic bearing, a magnetic fluid seal, and a brushless DC motor provided contact-free rotation of the impeller without material wear.     

Using Hybrid Magnetic Bearings to Completely Suspend the Impeller of a Ventricular Assist Device

Abstract Clinically available blood pumps and those under development suffer from poor mechanical reliability and poor biocompatibility related to anatomic fit, hemolysis, and thrombosis. To alleviate these problems concurrently in a long-term device is a substantial challenge. Based on testing the performance of a prototype, and on our judgment of desired characteristics, we have configured an innovative ventricular assist device, the CF-VAD4, for long-term use. The design process and its outcome, the CFVAD4 system configuration, is described. To provide unprecedented reliability and biocompatibility, magnetic bearings completely suspend the rotating pump impeller. The CFVAD4 uses a combination of passive (permanent) and active (electric) magnetic bearings, a mixed flow impeller, and a slotless 3-phase brushless DC motor. These components are shaped, oriented, and integrated to provide a compact, implantable, pancake-shaped unit for placement in the left upper abdominal quadrant of adult humans.     

Development of a Centrifugal Pump with Improved Antithrombogenicity and Hemolytic Property for Chronic Circulatory Support

Abstract A centrifugal pump with a unique structure has been developed for chronic support. The pump is driven by a magnetic coupling and has no rotating shaft, no seal around the rotating part, and a balancing hole at the center of the impeller and the thrust bearing. The pump was improved in stepwise fashion to realize good antithrombogenicity and low hemolysis. The first pump, the National Cardiovascular Center (NCVC)-O, had an impeller with 4 rectangular and curved vanes; 6 triangularly shaped curved vanes were employed in the second model, the NCVC-1, to reduce trauma to the blood. In the third design, the NCVC-2, the central hole was enlarged, and the thrust bearing shoulder was rounded so that blood washing was enhanced around the impeller; stream lines also were smoothed for improved antithrombogenicity. The hemolytic property of the device was evaluated in vitro with heparinized fresh goat blood; hemolysis indexes of the NCVC-0, -1, and -2 were 0.05, 0.01, and 0.006 g per 100 L, respectively. Antithrombogenicity of the pumps was examined in animal experiments as a left heart bypass device in goats weighing 52–75 kg. Six NCVC-0 pumps were driven for 14 to 33 (22.0 ± 7.6) days in goats receiving the antiplatelet drug cilostazol orally. Four NCVC-I pumps ran for 1 to 80 (28.5 ± 30.6) days with the same drug regimen in 2 cases and with no anticoagulation therapy in 2 cases. After 3 preliminary 1-week tests of NCVC-2 pumps in animals, the pump was installed in 3 goats; 2 pumps were still running on the 182nd and 58th pumping day. Intracorporeal implantation also was attempted successfully. The results indicate that this pump has promising features for chronic support although longer term and additional evaluations are necessary.     

Centrifugal blood pump with a hydraulically-levitated impeller for a permanently implantable biventricular assist device

A permanently implantable biventricular assist device (BVAD) system has been developed with a centrifugal pump which is activated by a hydraulically-levitated impeller. The pump impeller floats hydraulically into the top contact position; this position prevents thrombus formation by creating a washout effect at the bottom bearing area, a common stagnant region. The pump was subjected to in vitro studies using a pulsatile mock circulation loop to confirm the impeller's top contact position and the swinging motion produced by the pulsation. Eleven in vivo BVAD studies confirmed that this swinging motion eliminated blood clot formation. Twenty-one pumps im-planted for up to three months did not reveal any thrombosis in the pumps or downstream organs. One exception was a right pump which was exposed to severe low flow due to the kinking of the outflow graft by the accidental pulling of the flow meter cable. Three ninety-day BVAD studies were achieved without thrombus formation.     

Computational fluid dynamics analysis of hydrodynamic bearings of the VentrAssist rotary blood pump

The computational fluid dynamics (CFD) package CFX-TASCflow was applied to simulate the flows through the blood pump hydrodynamic bearings. The three-dimensional flow patterns through the bearings were predicted and the hydraulic performance analyzed. The computations were carried out at 3 axial positions of the pump impeller. Net lift force away from the nearer part of the housing increased when the impeller moved closer to this part. Radial force and drag force were also found. Separated flows were observed at the leading and trailing edge of the bearing gap. To test the CFD package, a series of two-dimensional computations were also carried out for various bearing geometries. The results were compared with published experimental data.     

Computational fluid dynamics analysis of a centrifugal blood pump with washout holes

The authors studied avoidance of coagulation occurrence using computational fluid dynamics (CFD) analysis from the fluid dynamical point of view. Concerning centrifugal pumps, blood coagulation sometimes occurs at the region behind the impeller where the flow is generally stagnant. Therefore, we conducted a thorough study with the specimen pump with and without washout holes, mocking up the Nikkiso HPM-15. As the result, the model with washout holes indicated that the fluid rotates rapidly at the vicinity of the shaft and generates washout effects near the stationary rear casing. On the other hand, the model without washout holes showed that fluid cannot be quickly shipped out of the area behind the impeller and rotates mildly around the shaft. To clarify the moving relations between the impeller and the fluid, validation studies by comparing the results of CFD analysis and flow visualization experiments are ongoing; thus far, the studies show that CFD results are similar to the results from flow visualization experiments.     

Fluid dynamic characteristics of the VentrAssist rotary blood pump

The VentrAssist pump has no shaft or seal, and the device is unique in design because the rotor is suspended passively by hydrodynamic forces, and urging is accomplished by an integrated direct current motor rotor that also acts as the pump impeller. This device has led to many challenges in its fluidic design, namely large flow-blockage from impeller blades, low stiffness of bearings with concomitant impeller displacement under pulsatile load conditions, and very small running clearances. Low specific speed and radial blade off-flow were selected in order to minimize the hemolysis. Pulsatile and steady-flow tests show the impeller is stable under normal operating conditions. Computational fluid dynamics (CFD) has been used to optimize flow paths and reduce net axial force imbalance to acceptably small values. The latest design of the pump achieved a system efficiency of 18% (in 30% hematocrit of red blood cells suspended in phosphate-buffered saline), and efficiency was optimized over the range of operating conditions. Parameters critical to improving pump efficiency were investigated.     

Numerical analysis of blood flow in the clearance regions of a continuous flow artificial heart pump

The CFVAD3 is the third prototype of a continuous flow ventricular assist device being developed for implantation in humans. The pump consists of a fully shrouded 4-blade impeller supported by magnetic bearings. On either side of this suspended rotating impeller is a small clearance region through which the blood flows. The spacing and geometry of these clearance regions are very important to the successful operation of this blood pump. Computational fluid dynamics (CFD) solutions for this flow were obtained using TascFlow, a software package available from AEA Technology, U.K. Flow in these clearance regions was studied parametrically by varying the size of the clearance, the blood flow rate into the pump, and the rotational speed of the pump. The numerical solutions yield the direction and magnitude of the flow and the dynamic pressure. Experimentally measured pump flow rates are compared to the numerical study. The results of the study provide guidance for improving pump efficiency. It is determined that current clearances can be significantly reduced to improve pump efficiency without negative impacts.     

A Seal-less Centrifugal Pump (Baylor Gyro Pump) for Application to Long-Term Circulatory Support

Abstract: We are developing a new centrifugal pump, the Baylor Gyro Centrifugal Pump (Gyro Pump), which can function for more than 2 weeks. The concept of the Gyro Pump is that a one-piece rotor-impeller with embedded permanent magnets, driven directly by a brushless direct current motor stator placed outside, rotates like a "gyro-scope," and the rotor-impeller is supported by one pivot bearing at the bottom in accordance with the gyroscopic principle. This concept enables us to eliminate a driving shaft and a seal between the driving shaft and the blood chamber, which results in extending the life of the centrifugal pump. The blood passes through the space between the motor stator and the rotor to the impeller portion. In this preliminary phase, two pivot bearings were applied to support the rotor-impeller at the top and the bottom inside the blood chamber. Both pivot bearings showed less blood trauma and less thrombogenicity in in vitro and in vivo studies. The Gyro Pump is a promising second-generation centrifugal pump for long-term circulatory support in the near future.     

Computational fluid dynamics-based hydraulic and hemolytic analyses of a novel left ventricular assist blood pump

The advent of various technologies has allowed mechanical blood pumps to become more reliable and versatile in recent decades. In our study group, a novel structure of axial flow blood pump was developed for assisting the left ventricle. The design point of the left ventricular assist blood pump 25 (LAP-25) was chosen at 4 Lpm with 100 mm Hg according to our clinical practice. Computational fluid dynamics was used to design and analyze the performance of the LAP-25. In order to obtain a required hydraulic performance and a satisfactory hemolytic property in the LAP-25 of a smaller size, a novel structure was developed including an integrated shroud impeller, a streamlined impeller hub, and main impeller blades with splitter blades; furthermore, tandem cascades were introduced in designing the diffuser. The results of numerical simulation show the LAP-25 can generate flow rates of 3-5 Lpm at rotational speeds of 8500-10,500 rpm, producing pressure rises of 27.5-148.3 mm Hg with hydraulic efficiency points ranging from 13.4 to 27.5%. Moreover, the fluid field and the hemolytic property of the LAP-25 were estimated, and the mean hemolysis index of the pump was 0.0895% with Heuser's estimated model. In conclusion, the design of the LAP-25 shows an acceptable result.     

Evaluation of left ventricular assist device performance and hydraulic force in a complete mock circulation loop

Centrifugal pump performance characteristics are vital in determining the ability of a prototype left ventricular assist device (LVAD) to meet the physiological circulation requirements of the cardiovascular system. These characteristics influence the static hydraulic forces encountered by the pump impeller, which determine the required load stiffness of suspension type bearings to minimize impeller touchdown. Performance investigations were conducted on an LVAD design while characterizing the impeller static hydraulic forces of various impeller/volute configurations. The pumps were inserted into a complete systemic and pulmonary mock circulation rig configured to provide suitable nonpulsatile or simulated pulsatile left heart failure environments. The single volute and closed shroud impeller configuration exhibited lowest radial (0.01 N) and axial (3 N) force at nonpulsatile design flow conditions, respectively. Normal hemodynamic conditions of 5.1 L/min at 94 mm Hg were re-established upon inserting the device into the left heart failure environment, where the pump operated along the nonpulsatile characteristic curve for 2200 rpm. The operational limits on this curve were dictated by the required pressure differential across the pump during systolic and diastolic periods. The reduction of left atrial pressure (25 to 8 mm Hg) indicated the alleviation of pulmonary congestion. The ability for the LVAD to support circulation in a left heart failure environment was successfully demonstrated in the mock circulation loop. The impeller hydraulic force characteristics attained will aid the bearing designer to select the best volute and impeller configuration to minimize impeller touchdown in magnetic, hydrodynamic or mechanical type bearing applications.     

Development of a magnetic fluid shaft seal for an axial-flow blood pump

A rotating impeller in a rotary blood pump requires a supporting system in blood, such as a pivot bearing or magnetic suspension. To solve potential problems such as abrasive wear and complexity of a supporting system, a magnetic fluid seal was developed for use in an axial-flow blood pump. Sealing pressures at motor speeds of up to 8,000 rpm were measured with the seal immersed in water or bovine blood. The sealing pressure was about 200 mm Hg in water and blood. The calculated theoretical sealing pressure was about 230 mm Hg. The seal remained perfect for 743 days in a static condition and for 180+ days (ongoing test) at a motor speed of 7,000 rpm. Results of measurement of cell growth activity indicated that the magnetic fluid has no negative cytological effects. The specially designed magnetic fluid shaft seal is useful for an axial-flow blood pump.     

System Considerations Favoring Rotary Artificial Hearts with Blood-Immersed Bearings

Abstract: Hydrodynamic blood pumps provide such advantages as not requiring an air vent or compliance chamber as well as a great reduction in mechanical complexity with the potential for very long durability. The detailed design of their bearings is emerging as the single most important determinant of long-term success. Three categories of bearings include remote force, such as magnetic suspension; blood-isolated, which require a shaft seal; and blood-immersed using either mechanical or hydrodynamic support. Blood-immersed bearings permit maximum simplification and miniaturization of the entire system, require no flush fluid, and require no electronics as with magnetic suspension. The Jarvik 2000* heart represents an example of their potential. The intraventricular titanium pump (25 mm diameter, 25 cc, 85 g), uses blood flow through the motor air gap with blood-immersed bearings. The longest in vitro bearing durability test is ongoing at 20,000,000,000 revolutions with minimal wear (3 years at 15,000 rpm). In vivo results include 5-month calf survival, no thromboembolism, plasma Hb 2–5 mg%, and power under 10 W. Key Words: Artificial hearts— Blood-immersed bearings—Rotary blood pumps—Axial flow pumps—Left-ventricular assist devices.     

Improvement of Hemocompatibility in Centrifugal Blood Pump With Hydrodynamic Bearings and Semi-open Impeller: In Vitro Evaluation

We have developed a noncontact-type centrifugal blood pump with hydrodynamic bearings and a semi-open impeller for mechanical circulatory assist. The impeller is levitated by an original spiral-groove thrust bearing and a herringbone-groove journal bearing, without any additional displacement-sensing module or additional complex control circuits. The pump was improved by optimizing the groove direction of the spiral-groove thrust bearing and the pull-up magnetic force between the rotor magnet and the stator coil against the impeller. To evaluate hemocompatibility, we conducted a levitation performance test and in vitro hemocompatibility tests by means of a mock-up circulation loop. In the hemolysis test, the normalized index of hemolysis was reduced from 0.721 to 0.0335 g/100 L corresponding to an expansion of the bearing gap from 1.1 to 56.1 µm. In the in vitro antithrombogenic test, blood pumps with a wide thrust bearing gap were effective in preventing thrombus formation. Through in vitro evaluation tests, we confirmed that hemocompatibility was improved by balancing the hydrodynamic fluid dynamics and magnetic forces.     

Numerical Study of a Bio‐Centrifugal Blood Pump With Straight Impeller Blade Profiles

Computational fluid dynamic simulations of the flow in the Kyoto‐NTN (Kyoto University, Kyoto, Japan) magnetically suspended centrifugal blood pump with a 16‐straight‐bladed impeller were performed in the present study. The flow in the pump was assumed as unsteady and turbulent, and blood was treated as a Newtonian fluid. At the impeller rotating speed of 2000 rpm and flow rate of 5 L/min, the pump produces a pressure head of 113.5 mm Hg according to the simulation. It was found that the double volute of the pump has caused symmetrical pressure distribution in the volute passages and subsequently caused symmetrical flow patterns in the blade channels. Due to the tangentially increasing pressure in the volute passages, the flow through the blade channels initially increases at the low‐pressure region and then decreases due to the increased pressure. The reverse flow and vortices have been identified in the impeller blade channels. The high shear stress of the flow in the pump mainly occurred at the inlet and outlet of the blade channels, the beginning of the volute passages and the regions around the tips of the cutwater and splitter plate. Higher shear stress is obtained when the tips of the cutwater and splitter plate are located at the impeller blade trailing edges than when they are located at the middle of the impeller blade channel. It was found that the blood damage index assessed based on the blood corpuscle path tracing of the present pump was about 0.94%, which has the same order of magnitude as those of the clinical centrifugal pumps reported in the literature.