Katsuhiro Ohuchi

Mechanical Damage of Red Blood Cells by Rotary Blood Pumps: Selective Destruction of Aged Red Blood Cells and Subhemolytic Trauma

In this study, mean cell volume (MCV), mean cell hemoglobin concentration (MCHC), and mean cell hemoglobin (MCH) were measured to quantify RBC damage by rotary blood pumps. Six-hour hemolysis tests were conducted with a Bio-pump BPX-80, a Sarns 15200 roller pump, and a prototype mag-lev centrifugal pump (MedTech Heart) using fresh porcine blood circulated at 5 L/min against a 100 mm Hg head pressure. The temperature of the test and noncirculated control blood was maintained at 37 degrees C. The normalized index of hemolysis (NIH) of each pump was determined by measuring the plasma-free hemoglobin level. The MCV was measured with a Coulter counter, and MCHC was derived from total hemoglobin and hematocrit. MCH was derived from MCV and MCHC. A multivariance statistical analysis (ANOVA) revealed statistically significant differences (n = 15, P < 0.05) in MCV, MCHC, and MCH between the blood sheared by the rotary blood pumps and the nonsheared control blood. Normalized to the control blood, the Bio-pump BPX-80 showed an MCV of 1.04 +/- 0.03, an MCHC of 0.95 +/- 0.04, and an MCH of 0.98 +/- 0.02; the mag-lev MedTech Heart had an MCV of 1.02 +/- 0.02, an MCHC of 0.97 +/- 0.02, and an MCH of 0.99 +/- 0.01; and the roller pump exhibited an MCV of 1.03 +/- 0.03, an MCHC of 0.96 +/- 0.03, and an MCH of 0.99 +/- 0.01. Per 0.01 increase in NIH, the BPX-80 showed a normalized MCV change of +10.1% and a normalized MCHC change of -14.0%; the MedTech Heart demonstrated a +6.9% MCV and -9.5% MCHC change; and the roller pump had a +0.5% MCV and -0.6% MCHC change. Due to shear in the pump circuits, the RBC increased while the MCHC decreased. The likely mechanism is that older RBCs with smaller size and higher hemoglobin concentration were destroyed fast by the shear, leaving younger RBCs with larger size and lower hemoglobin concentration. Subhemolytic trauma caused the intracellular hemoglobin to decrease due to gradual hemoglobin leakage through the micropores formed in the thinned membrane. In conclusion, the rate of change in MCV and MCHC with respect to NIH change provides useful information relating to selective destruction of RBCs, while the MCH level reflects subhemolytic damage.

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.

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 &mgr;m. High stiffness in the noncontrolled axes, Z, &PHgr;, and &thgr;, 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.

Feasibility of a miniature centrifugal rotary blood pump for low-flow circulation in children and infants.

In this study, a seal-less, tiny centrifugal rotary blood pump was designed for low-flow circulatory support in children and infants. The design was targeted to yield a compact and priming volume of 5 ml with a flow rate of 0.5–4 l/min against a head pressure of 40–100 mm Hg. To meet the design requirements, the first prototype had an impeller diameter of 30 mm with six straight vanes. The impeller was supported with a needle-type hydrodynamic bearing and was driven with a six-pole radial magnetic driver. The external pump dimensions included a pump head height of 20 mm, diameter of 49 mm, and priming volume of 5 ml. The weight was 150 g, including the motor driver. In the mock circulatory loop, using fresh porcine blood, the pump yielded a flow of 0.5–4.0 l/min against a head pressure of 40–100 mm Hg at a rotational speed of 1,800–4,000 rpm using 1/4” inflow and outflow conduits. The maximum flow and head pressure of 5.25 l/min and 244 mm Hg, respectively, were obtained at a rotational speed of 4,400 rpm. The maximum electrical-to-hydraulic efficiency occurred at a flow rate of 1.5–3.5 l/min and at a rotational speed of 2,000–4,400 rpm. The normalized index of hemolysis, which was evaluated using fresh porcine blood, was 0.0076 g/100 l with the impeller in the down-mode and a bearing clearance of 0.1 mm. Further refinement in the bearing and magnetic coupler are required to improve the hemolytic performance of the pump. The durability of the needle-type hydrodynamic bearing and antithrombotic performance of the pump will be performed before clinical applications. The tiny centrifugal blood pump meets the flow requirements necessary to support the circulation of pediatric patients.

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.

Deformability of human red blood cells exposed to a uniform shear stress as measured by a cyclically reversing shear flow generator

Red blood cells (RBCs) suspended in a dextran solution were at first loaded with a uniform shear stress of 21, 43 and 64 Pa for the duration of 0, 10, 20, 30, 45 and 60 min, respectively, followed with measurement of the dynamic deformation in terms of stretching and recovery, using a cyclically reversing sinusoidal shear flow with the peak stress of 128 Pa at 2 Hz. The L/W value, where L and W were the major and minor axis length of the RBC images, was derived to compare the effects of the uniform shear stress level and the exposure time. The exposure to the uniform shear stress of 21 Pa for the duration of as long as 60 min caused statistically insignificant L/W change in comparison to the control RBCs with L/W of 4.6 +/- 0.1. The exposure to 43 and 64 Pa for longer than 45 and 20 min, respectively, induced statistically significant change in the maximal L/W when compared to that of 21 Pa (p < 0.05). The composition of the maximal L/W values varied depending on the stress level and exposure time; with 21 Pa, the majority of cells exhibited the maximal L/W larger than 4.0 and few cells less than 2.0, whereas with the increase in the stress level to 43 and 64 Pa, cells having less than 2.0 exceeded 50%. Cyclic reversing shear flow is a useful means to measure dynamic deformation capability of RBCs which may be sub-hemolytically sheared without lysis.

Efficacy of a miniature centrifugal rotary pump (TinyPump) for transfusion-free cardiopulmonary bypass in neonatal piglets.

We have developed a miniaturized semiclosed cardiopulmonary bypass (CPB) circuit incorporating a centrifugal blood pump (TinyPump) with a volume of 5 ml. The current study was undertaken to evaluate the hemolytic performance of the TinyPump in comparison with the BioPump and to investigate the impact of different CPB circuit volumes on hemodilution, coagulation, and the inflammatory response. Twelve 1-week-old piglets (3.4 ± 0.2 kg) were used. The circuit comprised a centrifugal pump, a membrane oxygenator, and a cardiotomy reservoir. Cardiopulmonary bypass was conducted with mild hypothermia at 150 ml/kg/min for 3 hours. Transfusion was not performed. Priming volume was 68 ml for the circuit with the TinyPump and 111 ml for the circuit with the BioPump. Although the TinyPump required higher speed, plasma free hemoglobin levels after CPB were not different between the groups. After CPB, the TinyPump group had a significantly higher hematocrit (27% ± 3% vs. 23% ± 3%) and lower platelet reduction rate, lower thrombin-antithrombin complex levels, and lower interleukin-6 levels. Better lung compliance with less water content was observed in the TinyPump group. The TinyPump maintained CPB with acceptable hemolysis and lower inflammatory responses. This miniaturized CPB circuit may make transfusion-free open heart surgery feasible in neonates and would help to prevent postoperative organ dysfunction.

The Re-design at the Transformer Portion of Transcutaneous Energy Transmission System for All Implantable Devices

All implantable devices, such as an artificial heart, an artificial lung, a pacemaker, a defibrillator, need electric power. So the electric power supply through the skin is requested. Then, it is transcutaneous energy transmission system (TETS) that has been studied and used a lot. TETS is the system which performs an electric power supply by non-contact transcutaneously using the electromagnetic induction phenomenon of an external primary side coil and a secondary side coil in human body. In this research, we are developing the core type TETS which applied for the implantable devices. In this paper, corresponding to various conditions, such as a difference in required electric power and transmission distance change, the core type transformer which can hold high transmission efficiency is designed.

Feasibility of a TinyPump system for pediatric CPB, ECMO, and circulatory assistance: hydrodynamic performances of the modified pump housing for implantable TinyPump.

The TinyPump is a miniature centrifugal blood pump with an extremely small priming volume of 5 ml, allowing blood transfusion free cardiopulmonary bypass as well as extracorporeal membrane oxygenation in pediatric patients. In this study, a new pump housing with the angled inlet port (25 degrees toward impeller center with respect to the flow axis) was designed to optimize the pump displaced volume and to extend the application of the TinyPump to implantable support The fluid dynamic performance analysis revealed that the head pressure losses increased from 3 to 17 mm Hg in comparison with straight port design as the pump rotational speed increased from 2,000 to 4,000 rpm. This was probably caused by perturbed flow patterns at the site of the inlet bent port area and streamline hitting the off-center of the impeller. No significant effect on pumping efficiency was observed because of modification in inlet port design. Modification in the inflow and outflow port designs together with the drive mechanism reduces the height of the pump system, including the motor, to 27 mm yielding the displaced volume of 68 ml in comparison with 40 mm of the paracorporeal system with the displaced volume of 105 ml. Further analysis in terms of hemolytic as well as antithrombogenic performance will be carried out to finalize the housing design for the implantable version of the TinyPump.

Transfusion-Free Neonatal Cardiopulmonary Bypass Using a TinyPump

BACKGROUND We devised a miniaturized circuit incorporating a TinyPump in the venous line to amplify the venous return. We compared this system to the conventional blood-primed circuit and investigated whether this circuit could maintain hematocrit levels without blood transfusion and reduce coagulation and inflammatory cascades. METHODS Thirteen 1-week-old piglets (3.7 ± 0.2 kg) were divided into group M (miniaturized circuits with TinyPump-assisted venous drainage without blood, n = 7) and group C (conventional circuits with blood priming, n = 6). Cardiopulmonary bypass (CPB) was performed at 150 to 180 mL·kg(-1)·min(-1) for 2 hours, including 60 minutes of cardioplegic cardiac arrest. Modified ultrafiltration (MUF) was subsequently performed. Data were acquired before CPB and after the end of MUF. RESULTS The priming volume including the hemofilter circuit of the main circuit required 152 mL in group M and 300 mL in group C. The mean hematocrit values in group M and group C were not significantly different during CPB (21.5% ± 2.0% versus 23.2% ± 1.3%) or after MUF (30.7% ± 2.1% versus 32.9% ± 4.0%). After MUF, group M had lower thrombin-antithrombin complex levels (16.7 ± 5.0 ng/mL versus 28.4 ± 8.4 ng/mL, p < 0.01) and interleukin-8 levels (2,867 ± 758 pg/mL versus 13,730 ± 5,220 pg/mL, p < 0.01) than group C. The pulmonary vascular resistance index was lower in group M after MUF (4,105 ± 862 dynes·cm(-5)·kg(-1) versus 6,304 ± 1,477 dynes·cm(-5)·kg(-1), p < 0.01). The lung water content was also better in group M (83.7% ± 0.5% versus 84.9% ± 0.5%, p < 0.01). CONCLUSIONS The minicircuit with TinyPump-assisted venous drainage successfully maintained acceptable hematocrit levels and the cardiopulmonary function in neonatal piglets. Employing this technique may attenuate blood requirements and inflammatory responses, thereby improving the clinical outcomes of neonatal open-heart surgery.