Magnetically suspended rotary blood pump with radial type combined motor-bearing

A magnetically suspended centrifugal blood pump is being developed with a combined motor-bearing for long-term ventricular assist systems. The combined motor-bearing actively suspends a rotor in a radial direction to deal with radial force unbalance in the pump and rotates the rotor by using the electric magnetic field. Therefore, the pump has no mechanical parts such as bearings of the motor and has a long lifetime. The developed pump consists of a thin rotor with a semi open-type 6 vane impeller and a stator to suspend and rotate the rotor. The rotor has 4-pole permanent magnets on the circumferential surface. The outer diameter and the thickness of the rotor are 60 mm and 8 mm, respectively. Axial movement and tilt of the rotor are restricted by passive stability based on the thin rotor structure. Radial movements of the rotor, such as levitation in radial direction and rotation, are controlled actively by using electric magnets of the stator. The electric magnet coils to produce levitation and rotation forces are constructed on the periphery stator. The p +/- 2-pole algorithm and the synchronous motor mechanism are adopted to levitate and rotate the rotor. The radial gap between the rotor and the stator is 1 mm. A closed-loop circuit filled with water was connected to the developed pump to examine the basic performance of the pump and the magnetic suspension system. Maximum rotational speed, flow rate, and head were 2,800 rpm, 11 L/min, and 270 mm Hg, respectively. The rotor with the impeller could be suspended completely during the entire pumping process. We conclude the pump with the combined motor-bearing has sufficient performance for the blood pump.     

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 compact highly efficient and low hemolytic centrifugal blood pump with a magnetically levitated impeller

A magnetically levitated (maglev) centrifugal blood pump (CBP), intended for use as a ventricular assist device, needs to be highly durable and reliable for long-term use without any mechanical failure. Furthermore, maglev CBPs should be small enough to be implanted into patients of various size and weight. We have developed a compact maglev CBP employing a two-degree-of-freedom controlled magnetic bearing, with a magnetically suspended impeller directly driven by an internal brushless direct current (DC) motor. The magnetic bearing actively controls the radial motion of the impeller and passively supports axial and angular motions using a permanent magnet embedded in the impeller. The overall dimensions of the maglev CBP are 65 mm in diameter and 40 mm in height. The total power consumption and pump efficiency for pumping 6 L/min against a head pressure of 105 mm Hg were 6.5 W and 21%, respectively. To evaluate the characteristics of the maglev CBP when subjected to a disturbance, excitation of the base, simulating the movement of the patient in various directions, and the sudden interception of the outlet tube connected with the pump in a mock circulatory loop, simulating an unexpected kink and emergent clamp during a heart surgery, were tested by monitoring the five-degree-of-freedom motion of the impeller. Furthermore, the hemolytic characteristics of the maglev CBP were compared with those of the Medtronic Biomedicus BPX-80, which demonstrated the superiority of the maglev CBP.     

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.     

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.     

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.     

The impact of pump speed and inlet cannulation site on left ventricular unloading with a rotary blood pump

BACKGROUND: Ventricular assist devices are gaining ground in the therapeutic treatment of chronic heart failure. These devices are sometimes used as a bridge to recovery by unloading the left ventricle (LV) and restoring its function. It is therefore important to preserve the heart muscle and apply less invasive implantation methods. METHODS: In this study ventricular unloading was achieved in 7 healthy sheep with a rotary blood pump at different pump flow levels. Ventricular cannulation via the left atrium (LA) and through the mitral valve was compared to atrial cannulation. The unloading of the heart was assessed with LV pressure-volume loops, derived energetic parameters, and an estimate of LV wall stress. RESULTS: No significant difference between the cannulations was found for any flow or pressure. LA cannulation, however, resulted in significantly lower stroke volumes and stroke work for all pump flow levels. Irrespective of cannulation site, LV volumes and energetic parameters showed a significant decrease with increasing pump flow. CONCLUSION: LV assist with a rotary blood pump can provide sufficient unloading with atrial cannulation.     

A magnetically levitated centrifugal blood pump with a simple-structured disposable pump head

Abstract:  A magnetically levitated centrifugal blood pump (MedTech Dispo) has been developed for use in a disposable extracorporeal system. The design of the pump is intended to eliminate mechanical contact with the impeller, to facilitate a simple disposable mechanism, and to reduce the blood-heating effects that are caused by motors and magnetic bearings. The bearing rotor attached to the impeller is suspended by a two degrees-of-freedom controlled radial magnetic bearing stator, which is situated outside the rotor. In the space inside the ringlike rotor, a magnetic coupling disk is placed to rotate the rotor and to ensure that the pump head is thermally isolated from the motor. In this system, the rotor can exhibit high passive stiffness due to the novel design of the closed magnetic circuits. The disposable pump head, which has a priming volume of 23 mL, consists of top and bottom housings, an impeller, and a rotor with a diameter of 50 mm. The pump can provide a head pressure of more than 300 mm Hg against a flow of 5 L/min. The normalized index of hemolysis of the MedTech Dispo is 0.0025 ± 0.0005 g/100 L at 5 L/min against 250 mm Hg. This is one-seventh of the equivalent figure for a Bio Pump BPX-80 (Medtronic, Inc., Minneapolis, MN, USA), which has a value of 0.0170 ± 0.0096 g/100 L. These results show that the MedTech Dispo offers high pumping performance and low blood trauma.     

Performance characterization of a rotary centrifugal left ventricular assist device with magnetic suspension

Abstract:  The MiTiHeart (MiTiHeart Corporation, Gaithersburg, MD, USA) left ventricular assist device (LVAD), a third-generation blood pump, is being developed for destination therapy for adult heart failure patients of small to medium frame that are not being served by present pulsatile devices. The pump design is based on a novel, patented, hybrid passive/active magnetic bearing system with backup hydrodynamic thrust bearing and exhibits low power loss, low vibration, and low hemolysis. Performance of the titanium alloy prototype was evaluated in a series of in vitro tests with blood analogue to map out the performance envelop of the pump. The LVAD prototype was implanted in a calf animal model, and the in vivo pump performance was evaluated. The animal's native heart imparted a strong pulsatility to the flow rate. These tests confirmed the efficacy of the MiTiHeart LVAD design and confirmed that the pulsatility does not adversely affect the pump performance.     

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.     

Initial in vivo experience of the VentrAssist implantable rotary blood pump in sheep

VentrAssist (VentrAssist Division, Ventracor Ltd., Chatswood, NSW, Australia) has developed an implantable centrifugal blood pump with an integrated rotor and impeller that is hydrodynamically suspended. Bench testing has been used to assess the performance of the pump under a broad range of operating conditions. This study examined the performance of the pump in vivo up to 90 days implantation. Pumps were implanted via a left lateral thoracotomy. The inflow cannula was inserted at the apex of the left ventricle. The outflow cannula was anastomosed to the descending thoracic aorta. Eighteen implants were performed. Poor recovery from surgery was the main cause of early study termination. These studies demonstrate the suitability of the animal model for evaluation of the VentrAssist rotary blood pump. Further in vivo studies prior to preclinical trials are in progress.     

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.     

Impeller behavior and displacement 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 is of the centrifugal type and consists of a shaftless impeller, also acting as the rotor of the brushless DC motor. The impeller remains passively suspended in the pump cavity by hydrodynamic forces, resulting from the small clearances between the impeller outside surfaces and the pump cavity. In the older version of the pump tested, these small clearances range from approximately 50 microm to 230 microm; the displacement of the impeller relative to the pump cavity is unknown in use. This article presents two experiments: the first measured displacement of the impeller using eddy-current proximity sensors and laser proximity sensors. The second experiment used Hall-effect proximity sensors to measure the displacement of the impeller relative to the pump cavity. All transducers were calibrated prior to commencement of the experiments. Voltage output from the transducers was converted into impeller movement in five degrees of freedom (x, y, z, theta(x), and theta(y)). The sixth degree of freedom, the rotation about the impeller axis (theta(z)), was determined by the commutation performed by the motor controller. The impeller displacement was found to be within the acceptable range of 8 micro m to 222 microm, avoiding blood damage and contact between the impeller and cavity walls. Thus the impeller was hydrodynamically suspended within the pump cavity and results were typical of centrifugal pump behavior. This research will be the basis for further investigation into the stiffness and damping coefficient of the pump's hydrodynamic bearing.     

Axial type self-bearing motor for axial flow blood pump

An axial self-bearing motor is proposed which can drive an axial blood pump without physical contact. It is a functional combination of the bi-directional disc motor and the axial active magnetic bearing, where it actively controls single degree-of-freedom motion, while other motions such as lateral vibration are passively stable. For application to a blood pump, the proposed self-bearing motor has the advantages of simple structure and small size. Through the finite element method (FEM) analysis and the experimental test, its good feasibility is verified. Finally, the axial flow pump is fabricated using the developed magnetically suspended motor. The pump test is carried out and the results are discussed in detail.     

Development of a disposable magnetically levitated centrifugal blood pump (MedTech Dispo) intended for bridge-to-bridge applications--two-week in vivo evaluation

Last year, we reported in vitro pump performance, low hemolytic characteristics, and initial in vivo evaluation of a disposable, magnetically levitated centrifugal blood pump, MedTech Dispo. As the first phase of the two-stage in vivo studies, in this study we have carried out a 2-week in vivo evaluation in calves. Male Holstein calves with body weight of 62.4–92.2 kg were used. Under general anesthesia, a left heart bypass with a MedTech Dispo pump was instituted between the left atrium and the descending aorta via left thoracotomy. Blood-contacting surface of the pump was coated with a 2-methacryloyloxyethyl phosphorylcholine polymer. Post-operatively, with activated clotting time controlled at 180–220 s using heparin and bypass flow rate maintained at 50 mL/kg/min, plasma-free hemoglobin (Hb), coagulation, and major organ functions were analyzed for evaluation of biocompatibility. The animals were electively sacrificed at the completion of the 2-week study to evaluate presence of thrombus inside the pump,together with an examination of major organs. To date, we have done 13 MedTech Dispo implantations, of which three went successfully for a 2-week duration. In these three cases, the pump produced a fairly constant flow of 50 mL/Kg/min. Neurological disorders and any symptoms of thromboembolism were not seen. Levels of plasma-free Hb were maintained very low. Major organ functions remained within normal ranges. Autopsy results revealed no thrombus formation inside the pump. In the last six cases, calves suffered from severe pneumonia and they were excluded from the analysis. The MedTech Dispo pump demonstrated sufficient pump performance and biocompatibility to meet requirements for 1-week circulatory support. The second phase (2-month in vivo study) is under way to prove the safety and efficacy of MedTech Dispo for 1-month applications.     

Control strategy for rotary blood pumps

The control strategy for ventricular support with a centrifugal blood pump was examined in this study. The control parameter was the pump rpm that determines pump flow. Optimum control of pump rpm that reflects the body's demand is important for long-term, effective, and safe circulatory support. Moreover, continuous, reliable monitoring of ventricular function will help successfully wean the patients from the ventricular assist device (VAD). The control strategy in this study includes determination of the target pump rpm that can provide the flow required by the body, fine-rpm-tuning to minimize deleterious effects such as suction in the ventricle, and assessment of ventricular function for successful weaning from VADs. To determine the target pump rpm, we proposed to use the relation between the native heart rate and cardiac output, and the relation between the pump rpm and centrifugal pump output. For fine-tuning of the pump rpm, the motor current waveform was used. We computed the power spectral density of the motor current waveform and calculated the ratio of the fundamental to the higher order components. When this ratio was larger than approximately 0.2, we assumed there would be a suction effect in the ventricle. As for assessment of ventricular function, we used the amplitude of the motor current waveform. The control system implemented using a DSP functioned properly in the mock circulatory loop as well as in acute animal experiments. The motor current also showed a good correlation with the ventricular pressure in acute animal experiments.     

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.     

Evaluation of left ventricular relaxation in rotary blood pump recipients using the pump flow waveform: a simulation study

In heart failure, diastolic dysfunction is responsible for about 50% of the cases, with higher prevalence in women and elderly persons and contributing similarly to mortality as systolic dysfunction. Whereas the cardiac systolic diagnostics in ventricular assist device patients from pump parameters have been investigated by several groups, the diastolic behavior has been barely discussed. This study focuses on the determination of ventricular relaxation during early diastole in rotary blood pump (RBP) recipients. In conventional cardiology, relaxation is usually evaluated by the minimum rate and the time constant of left ventricular pressure decrease, dP/dt(min) and τ(P) . Two new analogous indices derived from the pump flow waveform were investigated in this study: the minimum rate and the time constant of pump flow decrease, dQ/dt(min) and τ(Q) . The correspondence between the indices was investigated in a numerical simulation of the assisted circulation for different ventricular relaxation states (τ(P) ranging from 24 to 68 ms) and two RBP models characterized by linear and nonlinear pressure-flow characteristics. dQ/dt(min) and τ(Q) always correlated with the dP/dt(min) and τ(P) , respectively (r>0.97). These relationships were influenced by the nonlinear pump characteristics during partial support and by the pump speed during full support. To minimize these influences, simulation results suggest the evaluation of dQ/dt(min) and τ(Q) at a pump speed that corresponds to the borderline between partial and full support. In conclusion, at least in simulation, relaxation can be derived from pump data. This noninvasively accessible information could contribute to a continuous estimation of the remaining cardiac function and its eventual recovery.     

Analytical investigation of leakage flow in disk clearance of a magnetically suspended centrifugal impeller

Leakage flow through the disk clearance of a magnetically suspended centrifugal blood pump is essential for a good washout. An analytical approach, based on the theory of lubrication, is used to predict the leakage volume flow rate, nondimensional radial velocity, nondimensional mean pressure distribution, and comparative shear stress distribution for different disk clearance geometry under varying rotational speeds. The results showed that nondimensional mean pressure distribution and nondimensional radial velocity distribution along the clearance are independent of rotational speed. The flow through the gap depends on a nondimensional parameter S that denotes the ratio of centrifugal forces to the head generating capability of the impeller. It was found that an impeller having a lower S has less possibility of flow reversals in the gap, and gap with maximum height at the outside radius also is more susceptible to flow reversals at the impeller surface. The comparative shear stress within the gap reveals that, in general, the scalar stress is below 500 N/m2.     

Control strategy for maintaining physiological perfusion with rotary blood pumps

We present arguments and simulation results in favor of a novel strategy for control of rotary blood pumps. We suggest that physiological perfusion is achieved when the blood pump is controlled to maintain an average reference differential pressure. In the case of rotary left ventricular assist devices, our simulations show that maintaining a constant average pressure difference between the left ventricle and aorta results in physiological perfusion over a wide range of physical activities and clinical cardiac conditions. We simulated rest, light, and strenuous exercise conditions, corresponding to cardiac demands of 4.92, 7.98, and 14.62 L/min, respectively. For different exercise levels, the clinical conditions ranged from normal to failing to asystolic heart. By maintaining a constant pressure difference of 75 mm Hg between the left ventricle and aorta, with either an axial or a centrifugal blood pump, a total cardiac output close to the physiological cardiac demand was achieved, irrespective of the heart condition. The simulations of the transitions between different levels of exercise indicate that with the same reference differential pressure, the proposed approach leads to rapid adaptation of the total cardiac output to physiological levels, while avoiding suction. Comparison with the traditional control strategy of maintaining a reference rotational speed (rpm) of the pump indicates that though the traditional approach has some degree of adaptability, it is only adequate over a narrow range of cardiac demand and clinical conditions of the patient. Our results indicate that the proposed approach is superior to the alternatives in providing an adequate and autonomous adaptation of the total cardiac output over a broad range of exercise conditions (expected when an assist device is used as a destination therapy) and clinical statuses of the native heart (such as further deterioration or recovery of cardiac function), while having the potential to improve the quality of life of patients by reducing the need for monitoring and frequent human intervention. The proposed approach can be clinically implemented using simple controllers, and requires the implantation of two pressure sensors, or estimation of the pressure difference based on other available measurements.