PubMed Health⌕ Search

Biomedical subjects

Setsuo Takatani

Publications and source records attributed to Setsuo Takatani.

At least 19 recordsLinked to original sources

Dynamic deformation and recovery response of red blood cells to a cyclically reversing shear flow: Effects of frequency of cyclically reversing shear flow and shear stress level.

Dynamic deformation and recovery responses of red blood cells (RBCs) to a cyclically reversing shear flow generated in a 30-microm clearance, with the peak shear stress of 53, 108, 161, and 274 Pa at the frequency of 1, 2, 3, and 5 Hz, respectively, were studied. The RBCs' time-varying velocity varied after the glass plate velocity without any time lag, whereas the L/W change, where L and W were the major and minor axes of RBCs' ellipsoidal shape, exhibited a rapid increase and gradual decay during the deformation and recovery phase. The time of minimum L/W occurrence lagged behind the zero-velocity time of the glass plate (zero stress), and the delay time normalized to the one-cycle duration remained constant at 8.0%. The elongation of RBCs at zero stress time became larger with the reversing frequency. A simple mechanical model consisting of an elastic linear element during a rapid elongation period and a parallel combination of elements such as a spring and dashpot during the nonlinear recovery phase was suggested. The dynamic response behavior of RBCs under a cyclically reversing shear flow was different from the conventional shape change where a steplike force was applied to and completely released from the RBCs.

Blood Flow Velocity↗

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.

Animals↗

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.

Heart Failure↗

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.

Heart Ventricles↗

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.

Biomedical Engineering↗

Influence of radial clearance and rotor motion to hemolysis in a journal bearing of a centrifugal blood pump.

Hemolysis due to narrow clearance of noncontact bearings is a critical problem for rotary blood pumps. We developed a centrifugal blood pump with a magnetic and hydrodynamic hybrid bearing, and found that the hemolysis in the narrow clearance depends not only on the clearance size, but also on the rotor stability. In this study, we quantified the relation between the hemolysis, radial clearance (c), and rotor stability through the measurement of the rotor motion and hemolysis. As a result, it was confirmed that the rotor of the current pump is stabilized within the oscillation of 20 microm in blood, and the hemolysis decreases with increase in the c, which is the opposite in the unstable rotor motion with the previous pump. In order to theoretically discuss this hemolysis tendency, we implemented hemolysis estimation in the c according to hydrodynamics and hemodynamics. This estimation can represent the measured hemolysis tendency, and revealed that the flow rate has large influence on the hemolysis in the c.

Centrifugation↗

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.

Animals↗

Currently available ventricular-assist devices: capabilities, limitations and future perspectives.

The continuous progress in ventricular-assist device (VAD) technology and the management of patients with VADs has broadened the treatment options for end-stage heart failure patients. The available line-up of clinical devices provides the current optimal therapies to meet the specific needs of each patient. The extended durability, safety, efficacy and improved quality of life of the patients provides sufficient proof for the VAD to be a likely alternative therapy to heart transplantation. The sequential progress from the first-, to the second- and to the third-generation VAD technology is expected to bring increasing benefits to clinical outcomes. This article reviews the current status, capabilities, limitations and future perspectives of currently available VADs by generally classifying them via support duration, alignment of pump devices and via pulsatile or nonpulsatile mode of perfusion. Furthermore, the future direction of research and development for next-generation VADs is presented based on the lessons learned from currently available VADs.

Clinical Trials as Topic↗

Mechanical circulatory support devices (MCSD) in Japan: current status and future directions.

The current status and future directions of mechanical circulatory support devices (MCSDs) in Japan are reviewed. Currently used clinical MCSDs, both domestic and imported systems and continuous flow devices that are coming into the clinical arena are emphasized. Clinical MCSDs include the extracorporeal pulsatile Toyobo and Zeon systems and the implantable Novacor and HeartMate I VE. A thorough review is presented of single-ventricle continuous flow MCSDs such as the Terumo DuraHeart and the SunMedical EVAHEART and the biventricular Miwatec/Baylor systems that are on the horizon. The future directions in management of end-stage cardiac patients with MCSDs are discussed, focusing on (1) device selection - pulsatile versus continuous flow devices; (2) single-ventricle support, biventricular support, or replacement; (3) bridge to transplantation, destination therapy, or bridge to recovery; and (4) government regulatory processes and the medical industry. We hope to promote the quality of life (QOL) of end-stage cardiac patients as well as the medical industry in Japan.

Animals↗

Segmented polyurethane modified by photopolymerization and cross-linking with 2-methacryloyloxyethyl phosphorylcholine polymer for blood-contacting surfaces of ventricular assist devices.

To improve the biocompatibility of pulsatile ventricular assist devices (VADs), the blood-contacting surface of the segmented polyurethane (SPU) diaphragm employed in an electromechanical VAD was modified by introducing 2-methacryloyloxyethyl phosphorylcholine (MPC) units into its surface and forming an interpenetrating polymer network (IPN) structure, which contained independently cross-linked MPC polymer and SPU. The SPU diaphragm modified with an IPN structure was then assembled into a target test pump and underwent continuous pump operation at 37 degrees C for 2 weeks in a simulated systemic circulation using a mock circulatory loop. The surface characteristics of the pump diaphragm after 2 weeks of pump operation were then analyzed with an X-ray photoelectron spectroscope (XPS) and gold-colloid-labeled immunoassay. The XPS surface analysis of the IPN-modified SPU indicated the firm anchoring of MPC units even after 2 weeks of pump operation (the phosphor : carbon ratio was reduced by only 0.09%). The IPN-modified diaphragm prevented protein adsorption as well as cell adhesion in comparison to the unmodified SPU surface. This result thus validated that (1) the IPN structure could firmly secure MPC units to the SPU surface even in a high-mechanical-stress and high-shear environment, (2) the antithrombogenic power of MPC units remained unchanged after 2 weeks of continuous exposure to a high-shear environment, and (3) the IPN modified SPU cross-linked with MPC could be a powerful antithrombogenic surface for blood pumps used for chronic circulatory support of cardiac patients.

Biocompatible Materials↗

Quantification of the secondary flow in a radial coupled centrifugal blood pump based on particle tracking velocimetry.

Secondary flow in the centrifugal blood pump helps to enhance the washout effect and to minimize thrombus formation. On the other hand, it has an adverse effect on pump efficiency. Excessive secondary flow may induce hemolytic effects. Understanding the secondary flow is thus important to the design of a compact, efficient, biocompatible blood pump. This study examined the secondary flow in a radial coupled centrifugal blood pump based on a simple particle tracking velocimetry (PTV) technique. A radial magnetically coupled centrifugal blood pump has a bell-shaped narrow clearance between the impeller inner radius and the pump casing. In order to vary the flow levels through the clearance area, clearance widths of 0.25 mm and 0.50 mm and impeller washout holes with diameters of 0 mm, 2.5 mm, and 4 mm were prepared. A high-speed video camera (2000 frames per second) was used to capture the particle images from which radial flow components were derived. The flow in the space behind the impeller was assumed to be laminar and Couette type. The larger the inner clearance or diameter of washout hole, the greater was the secondary flow rate. Without washout holes, the flow behind the impeller resulted in convection. The radial flow through the washout holes of the impeller was conserved in the radial as well as in the axial direction behind the impeller. The increase in the secondary flow reduced the net pump efficiency. Simple PTV was successful in quantifying the flow in the space behind the impeller. The results verified the hypothesis that the flow behind the impeller was theoretically Couette along the circumferential direction. The convection flow observed behind the impeller agreed with the reports of other researchers. Simple PTV was effective in understanding the fluid dynamics to help improve the compact, efficient, and biocompatible centrifugal blood pump for safe clinical applications.

Biomedical Engineering↗

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.

Centrifugation↗

Measurement of the rotor motion and corresponding hemolysis of a centrifugal blood pump with a magnetic and hydrodynamic hybrid bearing.

This study proposed a centrifugal blood pump with a novel magnetic and hydrodynamic hybrid passive bearing, which consisted of a plain journal bearing for radial stability and a permanent magnetic bearing for axial and tilting stability. We measured the radial motion of the bearing and performed hemolysis tests for the different radial clearance sizes. In the results, it appeared that the radial motion had two modes: the stable center mode, in which the radius of the radial motion rapidly converged to less than 20 microm; and the unstable circle mode, in which the rotor suspension linearly increased with the rotation speed. It also appeared that the pumps with the radial clearance of 80 microm caused more hemolysis than with the smaller clearance sizes in the circle mode. The circle mode was avoidable by the higher rotation or the asymmetric pump structure, but the mechanism of hemolysis in this mode was still unclear.

Animals↗

Beyond implantable first generation cardiac prostheses for treatment of end-stage cardiac patients with clinical results in a multicenter.

After 30 years of research and development effort for both ventricular assist device (VAD) and total artificial heart (TAH) in the United States, they have been demonstrating effectiveness in the bridge to transplantation and destination therapy. Smaller size, long-term durable second generation and third generation blood pumps are now being tested in animals and moving to clinical applications. These are now combined with genetic engineering, tissue engineering and regenerative medical therapy techniques to provide newer treatment methodologies for end-stage cardiac patients. In Japan, heart transplantation was restarted in 1999, but to date only 13 transplants have been performed. Shortage in donor hearts is hindering the prevalence of heart transplantation. Over a dozen of end-stage cardiac patients are waiting for heart transplantation in hospital with a paracorporeal pneumatic VAD. Although implantable VADs have been imported from the USA, they have not acquired a wide clinical use yet because of their large size and high cost. There is a great need for development of a compact, low cost, totally implantable VAD and TAH in Japan to improve the quality of life of end-stage cardiac patients. This paper reviews the current status of the first generation pulsatile VAD and TAH as a bridge to transplantation and destination therapy around the world, followed with a review of the second and third generation blood pumps beyond the limitations of the first generation systems. Future recommendations are also discussed to improve the systems in Japan.

Animals↗

Biocompatible inkjet printing technique for designed seeding of individual living cells.

Inkjet printers are capable of printing at high resolution by ejecting extremely small ink drops. Established printing technology will be able to seed living cells, at micrometer resolution, in arrangements similar to biological tissues. We describe the use of a biocompatible inkjet head and our investigation of the feasibility of microseeding with living cells. Living cells are easily damaged by heat; therefore, we used an electrostatically driven inkjet system that was able to eject ink without generating significant heat. Bovine vascular endothelial cells were prepared and suspended in culture medium, and the cell suspension was used as "ink" and ejected onto culture disks. Microscopic observation showed that the endothelial cells were situated in the ejected dots in the medium, and that the number of cells in each dot was dependent on the concentration of the cell suspension and ejection frequency chosen. After the ejected cells were incubated for a few hours, they adhered to the culture disks. Using our non-heat-generating, electrostatically driven inkjet system, living cells were safely ejected onto culture disks. This microseeding technique with living cells has the potential to advance the field of tissue engineering.

Animals↗

One piece ultracompact totally implantable electromechanical total artificial heart for permanent use.

An ultracompact, one piece, totally implantable electromechanical total artificial heart (TAH) has been developed as a permanent replacement for failing hearts. It consists of left and right pusher plate blood pumps (stroke volume 55 ml) made of titanium alloy (Ti-6Al-7Nb) sandwiching a miniaturized electromechanical actuator between them. The diameter of the TAH is 90 mm, with a thickness of 70 mm, yielding an overall volume of 400 ml. It weighs 450 g. Although it is miniaturized, it provided a maximum pump output of 8 L/min against a left afterload of 100 mm Hg. It required approximately 12 watts to provide a pump output of 6.5 L/min with maximum efficiency of 13.5%. To balance left and right flow, the right stroke length was made 10% shorter than the left, and an auxiliary compliance chamber was used to compensate for additional flow differences between them. Motor commutation pulses and a Hall effect pusher plate sensor signal were used in the controller to implement the left master alternate variable rate mode. The calf fitting study revealed excellent anatomic compatibility, and the first successful survivor was obtained in December 2001. Studies of system endurance and biocompatibility are required to ensure long-term reliability. This TAH is promising for permanent replacement of the failing heart as well as for bridge to heart transplantation for the smaller size group of end-stage cardiac patients.

Animals↗

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.

Centrifugation↗