Experimental determination of dynamic characteristics of the VentrAssist implantable rotary blood pump

The VentrAssist implantable rotary blood pump, intended for long-term ventricular assist, is under development and is currently being tested for its rotor-dynamic stability. The pump consists of a shaftless impeller, which also acts as the rotor of the brushless DC motor. The impeller remains passively suspended in the pump cavity by hydrodynamic forces, which result from the small clearances between the outside surfaces of the impeller and the pump cavity. These small clearances range from approximately 50 microm to 230 microm in size in the version of pump reported here. This article presents experimental investigation into the dynamic characteristics of the impeller-bearing-pump housing system of the rotary blood pump for increasing pump speeds at different flow rates. The pump was mounted on a suspension system consisting of a platform and springs, where the natural frequency and damping ratio for the suspension system were determined. Real-time measurements of the impeller's displacement were performed using Hall effect sensors. A vertical disturbance force was exerted onto the pump housing, causing the impeller to be displaced in vertical direction from its dynamic equilibrium position within the pump cavity. The impeller displacement was represented by a decaying sine wave, which indicated the impeller restoring to its equilibrium position. From the decaying sine wave the natural frequency and stiffness coefficient of the system were determined. Furthermore, the logarithmic decrement method was used to determine the damping ratio and eventually the damping coefficient of the system. Results indicate that stiffness and damping coefficients increased as flow rate and pump speed increased, representing an increase in stability with these changing conditions. However, pump speed had a greater influence on the stiffness and damping coefficients than flow rate did, which was evident through dynamic analysis. Overall the experimental method presented in this article was successful in determining the dynamic characteristics of the system.     

Detection of left ventricle function from a magnetically levitated impeller behavior

The magnetically levitated (Mag-Lev) centrifugal rotary blood pump (CRBP) with two-degrees-of-freedom active control is promising for safe and long-term support of circulation. In this study, Mag-Lev CRBP controllability and impeller behavior were studied in the simulated heart failure circulatory model. A pneumatically driven pulsatile blood pump (Medos VAD [ventricular assist device]-54 mL) was used to simulate the left ventricle (LV). The Mag-Lev CRBP was placed between the LV apex and aortic compliance tank simulating LV assistance. The impeller behavior in five axes (x, y, z, theta, and phi) was continuously monitored using five eddy current sensors. The signals of the x- and y-axes were used for feedback active control, while the behaviors of the other three axes were passively controlled by the permanent magnets. In the static mock circuit, the impeller movement was controlled to within +/-10-+/-20 microm in the x- and y-axes, while in the pulsatile circuit, LV pulsation was modulated in the impeller movement with the amplitude being 2-22 microm. The amplitude of impeller movement measured at 1800 rpm with the simulated failing heart (peak LV pressure [LVP] = 70 mm Hg, mean aortic pressure [AoP(mean)] = 55 +/- 20 mm Hg, aortic flow = 2.7 L/min) was 12.6 microm, while it increased to 19.2 microm with the recovered heart (peak LVP = 122 mm Hg, AoP(mean) = 100 +/- 20 mm Hg, aortic flow = 3.9 L/min). The impeller repeated the reciprocating movement from the center of the pump toward the outlet port with LV pulsation. Angular rotation (theta, phi) was around +/-0.002 rad without z-axis displacement. Power requirements ranged from 0.6 to 0.9 W. Five-axis impeller behavior and Mag-Lev controller stability were demonstrated in the pulsatile mock circuit. Noncontact drive and low power requirements were shown despite the effects of LV pulsation. The impeller position signals in the x- and y-axes reflected LV function. The Mag-Lev CRBP is effective not only for noncontact low power control of the impeller, but also for diagnosis of cardiac function noninvasively.     

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.     

Centrifugal blood pump with a magnetically suspended impeller

A centrifugal blood pump with a magnetically suspended impeller has been developed. It has a single inlet and outlet, and it generates centrifugal forces by the rotating impeller. The fluid-dynamical design for inflow and outflow through the impeller leads to elimination of the axial force and unbalanced radial force acting on the impeller. Consequently, three-component control systems, instead of five-component ones, are enough to position the impeller. The magnetically suspended impeller rotates by the magnetic coupling with the permanent magnets embedded in the outer rotator of the motor. This pump has enough performance to function as a blood pump. Further research on the null-power magnetic suspension and the generation of an efficient rotating magnetic field is in progress.     

The Heartmate III: design and in vivo studies of a maglev centrifugal left ventricular assist device

A compact implantable centrifugal left ventricular assist device (LVAD) (HeartMate III) featuring a magnetically levitated impeller is under development. The goal of our ongoing work is to demonstrate feasibility, low hemolysis, and low thrombogenicity of the titanium pump in chronic bovine in vivo studies. The LVAD is based on so-called bearingless motor technology and combines pump rotor, drive, and magnetic bearing functions in a single unit. The impeller is rotated (theta z) and levitated with both active (X, Y) and passive (Z, theta x, theta y) suspension. Six prototype systems have been built featuring an implantable titanium pump (69 mm diameter, 30 mm height) with textured blood contacting surfaces and extracorporeal electronics. The pumps were implanted in 9 calves (< or = 100 kg at implant) that were anticoagulated with Coumadin (2.5 < or = INR < or = 4.0) throughout the studies. Six studies were electively terminated (at 27-61 days), 1 study was terminated after the development of severe pneumonia and lung atelectasis (at 27 days) another study was terminated after cardiac arrest (at 2 days) while a final study is ongoing (at approximately 100 days). Mean pump flows ranged from 2 to 7 L/min, except for brief periods of exercise at 6 to 9 L/min. Plasma free hemoglobin ranged from 4 to 10 mg/dl. All measured biochemical indicators of end organ function remained within normal range. The pumps have met performance requirements in all 9 implants with acceptable hemolysis and no mechanical failures.     

A New Magnetically Suspended Centrifugal Pump: In Vitro and Preliminary In Vivo Assessment

Abstract: To overcome problems derived from the shaft within the conventional centrifugal pump, we have been developing a new centrifugal pump, namely a magnetically suspended centrifugal pump (MSCP), which has no shaft and operates as a noncontacting and bearingless pump. The impeller is suspended magnetically between the magnetic bearing and the driving motor. Hemolysis tests were performed in comparison with the Biopump (BP80, BioMedicus). The index of hemolysis (IH) was significantly lower in the MSCP than in the Biopump. In addition, a smaller gap in the MSCP induced lower hemolysis. In preliminary studies using mongrel dogs, the layer of thrombus adherent to the impeller was observed in a few hours, which impaired the pumping efficiency. However, by using an impeller coated with silicone, no aggregations of platelets or fibrin on the impeller were observed in 24 h of continuous pumping. In conclusion, the MSCP had a gentler influence on blood cells than the Biopump, and the impeller coated with silicone may contribute to the long-term pumping of the MSCP.     

An ultradurable and compact rotary blood pump with a magnetically suspended impeller in the radial direction

A magnetically suspended centrifugal blood pump has been developed with a self-bearing motor for long-term ventricular assist systems. The rotor of the self-bearing motor is not only actively suspended in the radial direction, but also is rotated by an electromagnetic field. The pump has a long lifetime because there are no mechanical parts such as seals and motor bearings. An outer rotor mechanism was adopted for the self-bearing motor. The stator was constructed in the central space of the motor. The rotor shaped thin ring was set at the circumferential space of the stator. Six vanes were extended from the upper surface of the rotor toward the center of the pump to construct an open-type impeller. The outer diameter and the height of the impeller are 63 mm and 34 mm, respectively. The magnetic bearing method and the servomotor mechanism were adopted to levitate and rotate the rotor. Radial movements of the rotor and rotation are controlled actively by using electromagnets in the stator. Axial movement and tilt of the rotor are restricted by passive stability to simplify the control. The radial gap between the rotor and the stator is 1 mm. A closed-loop circuit filled with water was used to examine basic performance of the pump. Maximum flow rate and pressure head were 8 L/min and 200 mm Hg, respectively. Maximum amplitude of radial displacement of the impeller was 0.15 mm. The impeller could be suspended completely without touching the casing wall during the entire pumping process. Power consumption of the pump was only 9.5 W to produce a flow rate of 5 L/min against a pressure head of 100 mm Hg. We conclude that the pump has sufficient performance for the implantable ventricular assist system.     

Sensorless flow and head estimation in the VentrAssist rotary blood pump

Flow rate and pressure difference (or head) are key variables needed in the control of implantable rotary blood pumps. However, use of flow and/or pressure probes can decrease reliability and increase system power consumption and expense. For a given fluid viscosity, the flow state is determined by any 2 of the 4 pump variables: Flow, pressure difference, speed, and motor input power can be used. Thus, if viscosity is known or if its influence is sufficiently small, flow rate and pressure difference can be estimated from the motor speed and motor input power. For the VentrAssist centrifugal blood pump, which uses a hydrodynamic bearing, sensorless flow and pressure head estimation accuracy of 2 of our impeller designs were compared for a viscosity range of 1.2 to 4.5 mPas. This showed impeller design optimization can improve estimation accuracy. We also compared estimation accuracy using 2 blood analogues used in vitro, aqueous glycerol and red blood cells suspended in Haemaccel. The nature of the blood analogue and not only the viscosity of the fluid seems to influence estimation accuracy in our pump.     

Evaluation of hemolysis in the VentrAssist implantable rotary blood pump

The VentrAssist implantable rotary blood pump (IRBP) is an implantable centrifugal blood pump with a hydrodynamically suspended impeller; optimal efficiency requires small running clearances (70-300 microm). The effect of running clearance and polish on hemolysis was evaluated in vitro. Three different human blood suspensions were compared: phosphate buffered saline (PBS), plasma volume expander (Hemaccel), and whole blood. The test conditions were: blood hematocrit 30%, flow rate 5 L/min, pressure across pump 100 mm Hg, 6 h flow period, and 37 degrees C. Normalized Index of Hemolysis (NIH) for the Biomedicus BP-80, used as a control, was: 0.0040 +/- 0.0023 (n = 9; x +/- SD) and 0.00014 +/- 0.00009 (n = 5) for pooled blood suspensions in PBS and Hemaccel respectively, and 0.00053 +/- 0.0002 (n = 3) in whole blood. Hemolysis was reduced by improved surface finish and unaffected by running clearance. NIH for the VentrAssist IRBP with 0.2 microm Ra surface finish was 0.000167 +/- 0.00007 (n = 4) g/100 L in whole human blood, demonstrating minimal hemolysis.     

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.     

Use of Motor Current in Flow Rate Measurement for the Magnetically Suspended Centrifugal Blood Pump

Abstract: Indirect measurement of the flow rate of a centrifugal blood pump using the driving motor current was studied. The pump flow rate can be expressed as a function of the motor current under a given motor speed in the absence of energy loss resulting from uncertain mechanical contact friction. The magnetically suspended centrifugal blood pump (MSCP), developed by the collaboration of Kyoto University and NTN Inc., was suitable for the application of this measuring method because the impeller is suspended magnetically inside the pump housing without any mechanical contact. The effect of fluid viscosity on the pump performance was investigated in detail, and it was possible to estimate the pump flow rate and the pressure difference through the pump (from inlet port to outlet port) accurately by monitoring the motor current and speed when the kinematic viscosity of working fluids was known. The kinematic viscosity of working fluids can also be measured with the MSCP. The motor current and motor speed were monitored in a chronic animal experiment, and the estimated flow rate and pressure difference showed good correlation with directly measured data.     

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.     

Test Controller Design, Implementation, and Performance for a Magnetic Suspension Continuous Flow Ventricular Assist Device

A new continuous flow ventricular assist device using full magnetic suspension has been designed, constructed, and tested. The magnetic suspension centers the centrifugal pump impeller within the clearance passages in the pump, thus avoiding any form of contact. The noncontact operation is designed to give very high expected mechanical reliability, large clearances, low hemolysis, and a relatively small size compared to current pulsatile devices. A unique configuration of magnetic actuators on the inlet side and exit sides of the impeller provides full 5 axis control and suspension of the impeller. The bearing system is divided into segments which allow for 3 displacement axes and 2 angular control axes. The controller chosen for the first suspension tests consists of a decentralized set of 5 proportional integral derivative (PID) controllers. This document describes both the controller and an overview of some results pertaining to the magnetic bearing performance. The pump has been successfully operated in both water and blood under design conditions suitable for use as a ventricular assist device.     

Magnetically suspended centrifugal blood pump with an axially levitated motor

The longevity of a rotary blood pump is mainly determined by the durability of its wearing mechanical parts such as bearings and seals. Magnetic suspension techniques can be used to eliminate these mechanical parts altogether. This article describes a magnetically suspended centrifugal blood pump using an axially levitated motor. The motor comprises an upper stator, a bottom stator, and a levitated rotor-impeller between the stators. The upper stator has permanent magnets to generate an attractive axial bias force on the rotor and electric magnets to control the inclination of the rotor. The bottom stator has electric magnets to generate attractive forces and rotating torque to control the axial displacement and rotation of the rotor. The radial displacement of the rotor is restricted by passive stability. A shrouded impeller is integrated within the rotor. The performance of the magnetic suspension and pump were evaluated in a closed mock loop circuit filled with water. The maximum amplitude of the rotor displacement in the axial direction was only 0.06 mm. The maximum possible rotational speed during levitation was 1,600 rpm. The maximum pressure head and flow rate were 120 mm Hg and 7 L/min, respectively. The pump shows promise as a ventricular assist device.     

A Sealless Centrifugal Blood Pump with Passive Magnetic and Hydrodynamic Bearings

We are developing a permanently implantable ventricular assist system based on a sealless centrifugal blood pump. The impeller of the pump is supported by a passive radial magnetic bearing acting in synergy with hydrodynamic bearings. Torque is transmitted to the impeller by electromagnetic coupling via an integrated axial flux gap motor. Computer modeling has been used extensively to guide the hydraulic and electromagnetic design of the pump. As part of the development effort, a prototype system was built, which consisted of a radial magnetic bearing, an axial air gap motor, and a pivot bearing to constrain the axial motion. The following testing has been completed to validate the design. First, hydraulic tests have demonstrated sufficient hydraulic performance. Second, preliminary in vitro evaluation of hemolysis was low compared to that of a BioPump control. Third, a 6 h in vivo experiment was successfully completed.     

Computational fluid dynamics analysis of the pediatric tiny centrifugal blood pump (TinyPump)

We have developed a tiny rotary centrifugal blood pump for the purpose of supporting circulation of children and infants. The pump is designed to provide a flow of 0.1-4.0 L/min against a head pressure of 50-120 mm Hg. The diameter of the impeller is 30 mm with six straight vanes. The impeller is supported by a hydrodynamic bearing at its center and rotated with a radial coupled magnetic driver. The bearing that supports rotation of the impeller of the tiny centrifugal blood pump is very critical to achieve durability, and clot-free and antihemolytic performance. In this study, computational fluid dynamics (CFD) analysis was performed to quantify the secondary flow through the hydrodynamic bearing at the center of the impeller and investigated the effects of bearing clearance on shear stress to optimize hemolytic performance of the pump. Two types of bearing clearance (0.1 and 0.2 mm) were studied. The wall shear stress of the 0.1-mm bearing clearance was lower than that of 0.2-mm bearing clearance at 2 L/min and 3000 rpm. This was because the axial component of the shear rate significantly decreased due to the narrower clearance even though the circumferential component of the shear rate increased. Hemolysis tests showed that the normalized index of hemolysis was reduced to 0.0076 g/100 L when the bearing clearance was reduced to 0.1 mm. It was found that the CFD prediction supported the experimental trend. The CFD is a useful tool for optimization of the hydrodynamic bearing design of the centrifugal rotary blood pump to optimize the performance of the pump in terms of mechanical effect on blood cell elements, durability of the bearing, and antithrombogenic performance.     

Development of a compact, sealless, tripod supported, magnetically driven centrifugal blood pump

In this study, a tripod supported sealless centrifugal blood pump was designed and fabricated for implantable application using a specially designed DC brushless motor. The tripod structure consists of 3 ceramic balls mounted at the bottom surface of the impeller moving in a polyethylene groove incorporated at the bottom pump casing. The follower magnet inside the impeller is coupled to the driver magnet of the motor outside the bottom pump casing, thus allowing the impeller to slide-rotate in the polyethylene groove as the motor turns. The pump driver has a weight of 230 g and a diameter of 60 mm. The acrylic pump housing has a weight of 220 g with the priming volume of 25 ml. At the pump rpm of 1,000 to 2,200, the generated head pressure ranged from 30 to 150 mm Hg with the maximum system efficiency being 12%. When the prototype pump was used in the pulsatile mock loop to assist the ventricle from its apex to the aorta, a strong correlation was obtained between the motor current and bypass flow waveforms. The waveform deformation index (WDI), defined as the ratio of the fundamental to the higher order harmonics of the motor current power spectral density, was computed to possibly detect the suction occurring inside the ventricle due to the prototype centrifugal pump. When the WDI was kept under the value of 0.20 by adjusting the motor rpm, it was successful in suppressing the suction due to the centrifugal pump in the ventricle. The prototype sealless, centrifugal pump together with the control method based on the motor current waveform analysis may offer an intermediate support of the failing left or right ventricle bridging to heart transplantation.     

Development of an Atraumatic Small Centrifugal Pump for Second-Generation Cardiopulmonary Bypass

A small and light direct-drive centrifugal pump has been developed for cardiopulmonary bypass. In the development process, blood compatibility studies including a hemolysis study, an in vitro fluid dynamic performance study, and in vivo durability and feasibility studies were performed. The centrifugal pump with a 50 mm diameter impeller resulted in almost the same index of hemolysis value as did a Bio-Medicus centrifugal pump. Heat dissipation from the motor was prevented by using a flexible drive cable. Forty-eight-hour sealing durability around the driving axis was accomplished by using a fluoro-rubber V-ring that connected to the hard chrome-plated stainless steel. In vitro and in vivo performances of the pump were satisfactory. Thrombus formation behind the impeller was prevented by using a holed impeller that generated blood flow from the back to the surface of the impeller. Elimination of air during priming procedures was also easier with this modification. This centrifugal pump has one-quarter of the priming volume, size, and weight of magnetically coupled centrifugal pump systems.     

Disposable magnetically levitated centrifugal blood pump: design and in vitro performance

A magnetically levitated (MagLev) centrifugal blood pump (CBP) with a disposable pump head has been designed to realize a safe, easy-to-handle, reliable, and low-cost extracorporeal blood pump system. It consisted of a radial magnetic-coupled driver with a magnetic bearing having a two-degree freedom control and a disposable pump head unit with a priming volume of 24 mL. The easy on-off disposable pump head unit was made into a three-piece system consisting of the top and bottom housings, and the impeller-rotor assembly. The size and weight of the disposable pump unit were 75 mm x 45 mm and 100 g, respectively. Because the structure of the pump head unit is easily attachable and removable, the gap between the electromagnets of the stator and the target material in the rotor increased to 1.8 mm in comparison to the original integrated bearing system of 1.0 mm. The pump performance, power requirements, and controllability of the magnetic bearing revealed that from 1400 to 2400 rpm, the pump performance remained fairly unchanged. The amplitudes of the X- and Y-axis rotor oscillation increased to +/- 24 microm. The axial displacement of the rotor, 0.4 mm, toward the top housing was also observed at the pump rpm between 1400 and 2400. The axial and rotational stiffness of the bearing were 15.9 N/mm and 4.4 Nm/rad, respectively. The MagLev power was within 0.7 Watts. This study demonstrated the feasibility of a disposable, magnetically suspended CBP as the safe, reliable, easy-to-handle, low-cost extracorporeal circulation support device.     

Performance of a Continuous Flow Ventricular Assist Device: Magnetic Bearing Design, Construction, and Testing

A new centrifugal continuous flow ventricular assist device, the CFVAD III, which is fully magnetic bearing suspended, has been developed. It has only one moving part (the impeller), has no contact (magnetic suspension), is compact, and has minimal heating. A centrifugal impeller of 2 inch outer diameter is driven by a permanent magnet brushless DC motor. This paper discusses the design, construction, testing, and performance of the magnetic bearings in the unit. The magnetic suspension consists of an inlet side magnetic bearing and an outlet side magnetic bearing, each divided into 8 pole segments to control axial and radial displacements as well as angular displacements. The magnetic actuators are composed of several different materials to minimize size and weight while having sufficient load capacity to support the forces on the impeller. Flux levels in the range of 0.1 T are employed in the magnetic bearings. Self sensing electronic circuits (without physical sensors) are employed to determine the impellar position and provide the feedback control signal needed for the magnetic bearing control loops. The sensors provide position sensitivity of approximately 0.025 mm. A decentralized 5 axis controller has been developed using modal control techniques. Proportional integral derivative controls are used for each axis to levitate the magnetically supported impeller.