Microbubble detection on ultrasound imaging by utilizing phase patterned waves.

Objective.Super-resolution ultrasonography offers the advantage of visualization of intricate microvasculature, which is crucial for disease diagnosis. Mapping of microvessels is possible by localizing microbubbles (MBs) that act as contrast agents and tracking their location. However, there are limitations such as the low detectability of MBs and the utilization of a diluted concentration of MBs, leading to the extension of the acquisition time. We aim to enhance the detectability of MBs to reduce the acquisition time of acoustic data necessary for mapping the microvessels.Approach.We propose utilizing phase patterned waves (PPWs) characterized by spatially patterned phase distributions in the incident beam to achieve this. In contrast to conventional ultrasound irradiation methods, this irradiation method alters bubble interactions, enhancing the oscillation response of MBs and generating more significant scattered waves from specific MBs. This enhances the detectability of MBs, thereby enabling the detection of MBs that were undetectable by the conventional method. The objective is to maximize the overall detection of bubbles by utilizing ultrasound imaging with additional PPWs, including the conventional method. In this paper, we apply PPWs to ultrasound imaging simulations considering bubble-bubble interactions to elucidate the characteristics of PPWs and demonstrate their efficacy by employing PPWs on MBs fixed in a phantom by the experiment.Main results.By utilizing two types of PPWs in addition to the conventional ultrasound irradiation method, we confirmed the detection of up to 93.3% more MBs compared to those detected using the conventional method alone.Significance.Ultrasound imaging using additional PPWs made it possible to increase the number of detected MBs, which is expected to improve the efficiency of bubble detection.

Batch Fine Magnetic Pattern Transfer Method on Permanent Magnets Using Coercivity Change during Heating for Magnetic MEMS.

In magnetic microelectromechanical systems (MEMSs), permanent magnets in the form of a thick film or thin plate are used for structural and manufacturing purposes. However, the geometric shape induces a strong self-demagnetization field during thickness-direction magnetization, limiting the surface magnetic flux density and output power. The magnets must be segmented or magnetized in a fine and multi-pole manner to weaken the self-demagnetization field. Few studies have been performed on fine multi-pole magnetization techniques that can generate a higher surface magnetic flux density than segmented magnets and are suitable for mass production. This paper proposes a batch fine multi-pole magnetic pattern transfer (MPT) method for the magnets of MEMS devices. The proposed method uses two master magnets with identical magnetic patterns to sandwich a target magnet. Subsequently, the coercivity of the target magnet is reduced via heating, and the master magnet's magnetic pattern is transferred to the target magnet. Stripe, checkerboard, and concentric circle patterns with a pole pitch of 0.3 mm are magnetized on the NdFeB master magnets N38EH with high intrinsic coercivity via laser-assisted heating magnetization. The MPT yields the highest surface magnetic flux density at 160 °C, reaching 39.7-66.1% of the ideal magnetization pattern on the NdFeB target magnet N35.

A Disposable Electromagnetic Bi-Directional Micropump Utilizing a Rotating Multi-Pole Ring Magnetic Coupling.

Electromagnetic bi-directional micropumps (EMBM) are indispensable for the development of portable devices which enable fluid transportation in forward and reverse directions. However, the high disposal cost of rare-earth magnets attached to the fluidic part and the low pump density due to multiple motors limit their practical application in disposable multi-channel microfluidic applications such as droplet-based oscillatory-flow (DBOF) rapid PCR amplification. Therefore, this paper presented a low-cost, disposable, high-pump-density EMBM. To reduce the disposal cost, we separated the magnets from the disposable fluidic part and used cylindrical holes to store and guide the magnet, which resulted in the ability to reuse all the magnets. To increase the pump density, we used the combination of one motor and one multi-pole ring magnet to drive several channels simultaneously. A proof-of-concept prototype with a pump density of 0.28 cm-2 was fabricated and experimentally evaluated. The fabricated micropump exhibited a maximum flow rate of 0.86 mL/min and a maximum backpressure of 0.5 kPa at a resonant frequency around 50 Hz. The developed multi-channel micropump with reusable magnets is highly beneficial to the development of low-cost and high-throughput rapid PCR amplification microchips and therefore can have a significant impact on timely infectious disease recognition and intervention.

Number concentration dependence of ultrasonic disruption ratio of diameter-sorted microcapsules.

The use of ultrasound to destroy microcapsules in microbubble-assisted drug delivery systems (DDS) is of great interest. In the present study, the disruption ratios of capsule clusters were measured by observing and experimentally analyzing microcapsules with polymer shells undergoing disruption by ultrasound. The microcapsules were dispersed in a planar microchamber filled with a gelatin gel and sonicated using 1 MHz focused ultrasound. Different capsule populations were obtained using a filtration technique to modify and control the capsule sizes. The disruption ratio as a function of the concentration of capsules was obtained through image processing of the recorded photomicrographs. We found that the disruption ratio for each population exponentially decreases as the particle number concentration (PNC) increases. The maximum disruption ratio of the diameter-sorted capsules was larger than that of polydispersed capsules. Particularly, for resonant capsule populations, the ratio was more than twice that of polydispersed capsules. Furthermore, the maximum disruption ratio occurred at higher concentrations as the mean particle diameter of the capsule cluster decreased.

Measuring real-time blood viscosity with a ventricular assist device.

Ventricular assist devices assist in blood circulation and form a crucial component of artificial hearts. While it is important to measure parameters such as the flow rate, pressure head and viscosity of the blood, implanting additional devices to do such measurements is inadvisable. To this end, we demonstrate the adaptation of a ventricular assist device for the purpose of measuring blood viscosity. Such an approach eliminates the need for additional dedicated viscometers in artificial hearts. In the proposed method, the blood viscosity is measured by applying radial vibrational excitation to the impeller in a ventricular assist device using its magnetic levitation system. During the measurement, blood is exposed to a combination of a low shear rate (≈100/s) generated by the radial vibration of the impeller and a high shear rate (>10,000/s) generated by the impeller's rotation. The apparent viscosity of blood depends on the shear rate, so we determined which shear rate was the dominant one in the proposed method. The measurement results showed that the viscosity measured by the proposed method was in good agreement with the reference viscosity measured with a high shear rate. The mean absolute deviation in the measurements using the proposed method and those obtained using a concentric cylindrical viscometer at a high shear rate was 0.12 mPa s for four samples of porcine blood, with viscosities ranging from 2.32 to 2.75 mPa s.

Development of a suspension type sliding planar motion table using magnetic fluid lubrication.

A sliding planar motion table system that can be used for the lens driving actuator of a laser cutting machine was developed. The system uses magnetic fluid as the lubricant to avoid the leakage of lubricating oil under the table and reduce environmental pollution. The motion table is suspended from the guide surface by an attractive force generated by electromagnets to reduce the contact and frictional forces between the table and the guide surface. The table is capable of movement in one rotational and two translational directions over the guide surface using six electromagnets and three non-contact displacement sensors. Experimental results showed that the magnetic suspension of the table reduced the friction by 82.1% compared to the friction that would otherwise be generated by the dead weight of the table. Circular motion within a diameter of 2 mm was achieved with resolutions of 5 µm and 20 µrad in the translational and rotational directions, respectively. A bandwidth of higher than 100 Hz was also achieved in the three movement directions.

Implantable power generation system utilizing muscle contractions excited by electrical stimulation.

An implantable power generation system driven by muscle contractions for supplying power to active implantable medical devices, such as pacemakers and neurostimulators, is proposed. In this system, a muscle is intentionally contracted by an electrical stimulation in accordance with the demands of the active implantable medical device for electrical power. The proposed system, which comprises a small electromagnetic induction generator, electrodes with an electrical circuit for stimulation and a transmission device to convert the linear motion of the muscle contractions into rotational motion for the magneto rotor, generates electrical energy. In an ex vivo demonstration using the gastrocnemius muscle of a toad, which was 28 mm in length and weighed 1.3 g, the electrical energy generated by the prototype exceeded the energy consumed for electrical stimulation, with the net power being 111 µW. It was demonstrated that the proposed implantable power generation system has the potential to replace implantable batteries for active implantable medical devices.

Sensorless Viscosity Measurement in a Magnetically-Levitated Rotary Blood Pump.

Controlling the flow rate in an implantable rotary blood pump based on the physiological demand made by the body is important. Even though various methods to estimate the flow rate without using a flow meter have been proposed, no adequate method for measuring the blood viscosity, which is necessary for an accurate estimate of the flow rate, without using additional sensors or mechanisms in a noninvasive way, has yet been realized. We have developed a sensorless method for measuring viscosity in magnetically levitated rotary blood pumps, which requires no additional sensors or mechanisms. By applying vibrational excitation to the impeller using a magnetic bearing, we measured the viscosity of the working fluid by measuring the phase difference between the current in the magnetic bearing and the displacement of the impeller. The measured viscosity showed a high correlation (R(2) > 0.992) with respect to a reference viscosity. The mean absolute deviation of the measured viscosity was 0.12 mPa·s for several working fluids with viscosities ranging from 1.18 to 5.12 mPa·s. The proposed sensorless measurement method has the possibility of being utilized for estimating flow rate.

MedTech Mag-Lev, single-use, extracorporeal magnetically levitated centrifugal blood pump for mid-term circulatory support.

Short- to mid-term extracorporeal ventricular assist devices (VADs) are recommended for critical cardiogenic shock patients. We have designed a preclinical, single-use MedTech Mag-Lev VAD for one-month extracorporeal use. The impeller-rotor of the pump was suspended by a two degree-of-freedom active magnetic bearing in a 300 µm fluid gap, where the computational fluid dynamics analysis predicted a secondary flow of about 400-500 ml/min at a pump speed of 1800-2200 rpm. Three eddy current sensors were employed to implement noise- and drift-free magnetic levitation. The pump components were injection molded using polycarbonate for smooth surfaces as well as improved reproducibility, followed by coating with a biocompatible 2-methacryloyl-oxyethyl phosphorylcholine polymer. Chronic animal experiments were performed in nine calves. Three of the nine calves were excluded from analysis for problems with the circuit. Five of the six (83.3%) completed the 60 day duration of the study, while one prematurely died of massive bleeding due to inflow port detachment. The pump did not stop due to magnetic-levitation malfunction. Neither pump thrombosis nor major organ infarction was observed at autopsy. In comparison to machined surfaces, the injection-molded pump surfaces were thrombus-free after 60 day implantation. This study demonstrates the feasibility of MedTech Mag-Lev VAD for 60 day circulatory support.

New generation extracorporeal membrane oxygenation with MedTech Mag-Lev, a single-use, magnetically levitated, centrifugal blood pump: preclinical evaluation in calves.

We have evaluated the feasibility of a newly developed single-use, magnetically levitated centrifugal blood pump, MedTech Mag-Lev, in a 3-week extracorporeal membrane oxygenation (ECMO) study in calves against a Medtronic Bio-Pump BPX-80. A heparin- and silicone-coated polypropylene membrane oxygenator MERA NHP Excelung NSH-R was employed as an oxygenator. Six healthy male Holstein calves with body weights of about 100 kg were divided into two groups, four in the MedTech group and two in the Bio-Pump group. Under general anesthesia, the blood pump and oxygenator were inserted extracorporeally between the main pulmonary artery and the descending aorta via a fifth left thoracotomy. Postoperatively, both the pump and oxygen flow rates were controlled at 3 L/min. Heparin was continuously infused to maintain the activated clotting time at 200-240 s. All the MedTech ECMO calves completed the study duration. However, the Bio-Pump ECMO calves were terminated on postoperative days 7 and 10 because of severe hemolysis and thrombus formation. At the start of the MedTech ECMO, the pressure drop across the oxygenator was about 25 mm Hg with the pump operated at 2800 rpm and delivering 3 L/min flow. The PO2 of the oxygenator outlet was higher than 400 mm Hg with the PCO2 below 45 mm Hg. Hemolysis and thrombus were not seen in the MedTech ECMO circuits (plasma-free hemoglobin [PFH] < 5 mg/dL), while severe hemolysis (PFH > 20 mg/dL) and large thrombus were observed in the Bio-Pump ECMO circuits. Plasma leakage from the oxygenator did not occur in any ECMO circuits. Three-week cardiopulmonary support was performed successfully with the MedTech ECMO without circuit exchanges. The MedTech Mag-Lev could help extend the durability of ECMO circuits by the improved biocompatible performances.

Fault-tolerant strategies for an implantable centrifugal blood pump using a radially controlled magnetic bearing.

In our laboratory, an implantable centrifugal blood pump (CBP) with a two degrees-of-freedom radially controlled magnetic bearing (MB) to support the impeller without contact has been developed to assist the pumping function of the weakened heart ventricle. In order to maintain the function of the CBP after damage to the electromagnets (EMs) of the MB, fault-tolerant strategies for the CBP are proposed in this study. Using a redundant MB design, magnetic levitation of the impeller was maintained with damage to up to two out of a total of four EMs of the MB; with damage to three EMs, contact-free support of the impeller was achieved using hydrodynamic and electromagnetic forces; and with damage to all four EMs, the pump operating point, of 5 l/min against 100 mmHg, was achieved using the motor for rotation of the impeller, with contact between the impeller and the stator.

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 62.4­92.2 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 180­220 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.

A new pulse duplicator with a passive fill ventricle for analysis of cardiac dynamics.

A new pulse duplicator was designed for evaluation of the performance of ventricular assist devices through pressure-volume (P-V) diagrams of the native heart. A linear drive system in combination with a pusher-plate mechanism was designed as a drive system to implement the passive fill mechanism during diastole of the mock ventricle. The compliances of the native heart during both diastole and systole were simulated by placing a ventricle sack made of soft latex rubber in a sealed chamber and by varying the air-to-fluid volume ratio inside the chamber. The ratio of the capacities of the systemic venous and pulmonary circuits was adjusted to properly reflect the effects of volume shift between them. As the air-to-fluid volume ratio was varied from 1:12.3 to 1:1.58, the contractility of the ventricle expressed by E (max) varied from 1.75 to 0.56 mmHg/ml with the mean V (0) of 4.58 ml closely mimicking those of native hearts (p < 0.05). Because the E (max) value of the normal human heart ranges from 1.3 to 1.6, with a value below 1.0 indicating heart failure, the mock ventricle is applicable in simulating the dynamics of the normal heart and the sick heart. The P-V diagram changes seen with rotary blood pump assistance revealed changes similar to those reported by other workers. The effects of the ventricular assist device, either pulsatile or continuous flow, on cardiac dynamics can be easily simulated with this system to derive design criteria for clinical circulatory assist devices.

Disposable MagLev centrifugal blood pump utilizing a cone-shaped impeller.

To enhance the durability and reduce the blood trauma of a conventional blood pump with a cone-shaped impeller, a magnetically levitated (MagLev) technology has been applied to the BioPump BPX-80 (Medtronic Biomedicus, Inc., Minneapolis, MN, USA), whose impeller is supported by a mechanical bearing. The MagLev BioPump (MagLev BP), which we have developed, has a cone-shaped impeller, the same as that used in the BPX-80. The suspension and driving system, which is comprised of two degrees of freedom, radial-controlled magnetic bearing, and a simply structured magnetic coupling, eliminates any physical contact between the impeller and the housing. To reduce both oscillation of the impeller and current in the coils, the magnetic bearing system utilizes repetitive and zero-power compensators. In this article, we present the design of the MagLev mechanism, measure the levitational accuracy of the impeller and pressure-flow curves (head-quantity [HQ] characteristics), and describe in vitro experiments designed to measure hemolysis. For the flow-induced hemolysis of the initial design to be reduced, the blood damage index was estimated by using computational fluid dynamics (CFD) analysis. Stable rotation of the impeller in a prototype MagLev BP from 0 to 2750 rpm was obtained, yielding a flow rate of 5 L/min against a head pressure in excess of 250 mm Hg. Because the impeller of the prototype MagLev BP is levitated without contact, the normalized index of hemolysis was 10% less than the equivalent value with the BPX-80. The results of the CFD analysis showed that the shape of the outlet and the width of the fluid clearances have a large effect on blood damage. The prototype MagLev BP satisfied the required HQ characteristics (5 L/min, 250 mm Hg) for extracorporeal circulation support with stable levitation of the impeller and showed an acceptable level of hemolysis. The simulation results of the CFD analysis indicated the possibility of further reducing the blood damage of the prototype MagLev BP.

Development of a disposable maglev centrifugal blood pump intended for one-month support in bridge-to-bridge applications: in vitro and initial in vivo evaluation.

MedTech Dispo, a disposable maglev centrifugal blood pump with two degrees of freedom magnetic suspension and radial magnetic coupling rotation, has been developed for 1-month extracorporeal circulatory support. As the first stage of a two-stage in vivo evaluation, 2-week evaluation of a prototype MedTech Dispo was conducted. In in vitro study, the pump could produce 5 L/min against 800 mm Hg and the normalized index of hemolysis was 0.0054 +/- 0.0008 g/100 L. In in vivo study, the pump, with its blood-contacting surface coated with biocompatible 2-methacryloyloxyethyl phosphorylcholine polymer, was implanted in seven calves in left heart bypass. Pump performance was stable with a mean flow of 4.49 +/- 0.38 L/min at a mean speed of 2072.1 +/- 64.5 rpm. The maglev control revealed its stability in rotor position during normal activity by the calves. During 2 weeks of operation in two calves which survived the intended study period, no thrombus formation was seen inside the pump and levels of plasma free hemoglobin were maintained below 4 mg/dL. Although further experiments are required, the pump demonstrated the potential for sufficient and reliable performance and biocompatibility in meeting the requirements for cardiopulmonary bypass and 1-week circulatory support.

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.

Third-generation blood pumps with mechanical noncontact magnetic bearings.

This article reviews third-generation blood pumps, focusing on the magnetic-levitation (maglev) system. The maglev system can be categorized into three types: (i) external motor-driven system, (ii) direct-drive motor-driven system, and (iii) self-bearing or bearingless motor system. In the external motor-driven system, Terumo (Ann Arbor, MI, U.S.A.) DuraHeart is an example where the impeller is levitated in the axial or z-direction. The disadvantage of this system is the mechanical wear in the mechanical bearings of the external motor. In the second system, the impeller is made into the rotor of the motor, and the magnetic flux, through the external stator, rotates the impeller, while the impeller levitation is maintained through another electromagnetic system. The Berlin Heart (Berlin, Germany) INCOR is the best example of this principle where one-axis control combination with hydrodynamic force achieves high performance. In the third system, the stator core is shared by the levitation and drive coil to make it as if the bearing does not exist. Levitronix CentriMag (Zürich, Switzerland), which appeared recently, employs this concept to achieve stable and safe operation of the extracorporeal system that can last for a duration of 14 days. Experimental systems including HeartMate III (Thoratec, Woburn, MA, U.S.A.), HeartQuest (WorldHeart, Ottawa, ON, Canada), MagneVAD (Gold Medical Technologies, Valhalla, NY, U.S.A.), MiTiHeart (MiTi Heart, Albany, NY, U.S.A.), Ibaraki University's Heart (Hitachi, Japan) and Tokyo Medical and Dental University/Tokyo Institute of Technology's disposable and implantable maglev blood pumps are also reviewed. In reference to second-generation blood pumps, such as the Jarvik 2000 (Jarvik Heart, New York, NY, U.S.A.), which is showing remarkable achievement, a question is raised whether a complicated system such as the maglev system is really needed. We should pay careful attention to future clinical outcomes of the ongoing clinical trials of the second-generation devices before making any further remarks. What is best for patients is the best for everyone. We should not waste any efforts unless they are actually needed to improve the quality of life of heart-failure patients.

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.