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

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.

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.

Hemolytic performance of a MagLev disposable rotary blood pump (MedTech Dispo): effects of MagLev gap clearance and surface roughness.

Mechanical shaft seal bearing incorporated in the centrifugal blood pumps contributes to hemolysis and thrombus formation. In addition, the problem of durability and corrosion of mechanical shaft seal bearing has been recently reported from the safety point of view. To amend the shortcomings of the blood-immersed mechanical bearings, a magnetic levitated centrifugal rotary blood pump (MedTech Dispo Model 1; Tokyo Medical and Dental University, Tokyo, Japan) has been developed for extracorporeal disposable application. In this study, the hemolytic performance of the MedTech Dispo Model 1 centrifugal blood pump system was evaluated, with special focus on the narrow blood path clearance at the magnetic bearing between rotor and stator, and on the pump housing surface roughness. A pump flow of 5 L/min against the head pressure of 100 mm Hg for 4 h was included in the hemolytic test conditions. Anticoagulated fresh porcine blood was used as a working fluid. The clearance of blood path at the magnetic bearing was in the range of 100-250 micro m. Pump housing surface roughness was controlled to be around Ra = 0.1-1.5 micro m. The lowest hemolytic results were obtained at the clearance of 250 micro m and with the polished surface (Ra = 0.1 micro m) yielding the normalized index of hemolysis (NIH) of less than 0.001 g/100 L, which was 1/5 of the Biopump BP-80 (Medtronic Inc., Minneapolis, MN, USA, and 1/4 of the BPX-80. In spite of rough surface and narrow blood path, NIH levels were less than clinically acceptable level of 0.005 g/100 L. The noncontact, levitated impeller system is useful to improve pump performance in blood environment.

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.

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.

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.

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.

Magnetically suspended centrifugal blood pump with a radial magnetic driver.

A new magnetic bearing has been designed to achieve a low electronic power requirement and high stiffness. The magnetic bearing consists of 1) radial passive forces between the permanent magnet ring mounted inside the impeller rotor and the electromagnet core materials in the pump casing and 2) radial active forces generated by the electromagnets using the two gap sensor signals. The magnetic bearing was assembled into a centrifugal rotary blood pump (CRBP) driven with a radial, magnetic coupled driver. The impeller vane shape was designed based upon the computational fluid dynamic simulation. The diameter and height of the CRBP were 75 mm and 50 mm, respectively. The magnetic bearing system required the power of 1.0-1.4 W. The radial impeller movement was controlled to within +/- 10 microm. High stiffness in the noncontrolled axes, Z, phi, and theta, was obtained by the passive magnetic forces. The pump flow of 5 L/min against 100 mm Hg head pressure was obtained at 1,800 rpm with the electrical to hydraulic efficiency being greater than 15%. The Normalized Index of Hemolysis (NIH) of the magnetic bearing CRBP was one fifth of the BioPump BP-80 and one half of the NIKKISO HPM-15 after 4 hours. The newly designed magnetic bearing with two degrees of freedom control in combination with optimized impeller vane was successful in achieving an excellent hemolytic performance in comparison with the clinical centrifugal blood pumps.

A new design for a compact centrifugal blood pump with a magnetically levitated rotor.

A compact centrifugal blood pump has been developed using a radial magnetic bearing with a two-degree of freedom active control. The proposed magnetic bearing exhibits high stiffness, even in passively controlled directions, and low power consumption because a permanent magnet, incorporated with the rotor, suspends its weight. The rotor is driven by a Lorentz force type of built-in motor, avoiding mechanical friction and material wear. The built-in motor is designed to generate only rotational torque, without radial and axial attractive forces on the rotor, leading to low power consumption by the magnetic bearing. The fabricated centrifugal pump measured 65 mm in diameter and 45 mm in height and weighed 0.36 kg. In the closed loop circuit filled with water, the pump provided a flow rate of 4.5 L/min at 2,400 rpm against a pressure head of 100 mm Hg. Total power consumption at that point was 18 W, including 2 W required for magnetic levitation, with a total efficiency of 5.7%. The experimental results showed that the design of the compact magnetic bearing was feasible and effective for use in a centrifugal blood pump.