Yasuhisa Ohara

Development of a Pivot Bearing Supported Sealless Centrifugal Pump for Ventricular Assist

Since 1991, in our laboratory, a pivot bearing-supported, sealless, centrifugal pump has been developed as an implantable ventricular assist device (VAD). For this application, the configuration of the total pump system should be relatively small. The C1E3 pump developed for this purpose was anatomically compatible with the small-sized patient population. To evaluate an-tithrombogenicity, ex vivo 2-week screening studies were conducted instead of studies involving an intracorpore-ally implanted VADs using calves. Five paracorporeal LVAD studies were performed using calves for longer than 2 weeks. The activated clotting time (ACT) was maintained at approximately 250 s using heparin. All of the devices demonstrated trouble-free performances over 2 weeks. Among these 5 studies, 3 implantations were subjected to 1-month system validation studies. There were no device-induced thrombus formations inside the pump housing, and plasma-free hemoglobin levels in calves were within the normal range throughout the experiment (35, 34, and 31 days). There were no incidents of system malfunction. Subsequently, the mass production model was fabricated and yielded a normalized index of hemolysis of 0.0014, which was comparable to that of clinically available pumps. The wear life of the impeller bearings was estimated at longer than 8 years. In the next series of in vivo studies, an implantable model of the C1E3 pump will be fabricated for longer term implantation. The pump-actuator will be implanted inside the body; thus the design calls for substituting plastic for metallic parts.

Flow visualization evaluation of secondary flow in a centrifugal blood pump.

To design a less hemolytic and more antithrombogenic centrifugal blood pump, secondary flow, i.e., vortex and turbulent flow, must be properly controlled. An irregular stream pattern is a cause of hemolysis, and good wash-out around the shaft minimizes thrombus formation. In this study, flow visualization methods were applied to evaluate secondary flow in a centrifugal blood pump. Correlation with results of in vitro hemolysis tests was investigated. Separation of the stream lines from the vanes and patterns implying the existence of vortices were observed in the impeller that showed high hemolysis. By adjustment of vane angles, these irregular patterns could be minimized, and hemolysis decreased as well. Using a similar technique, the flow pattern at the back of the impeller could be visualized, which enabled further investigation of the effects of secondary flow on thrombus formation. This flow visualization was effective in examining secondary flow patterns.

Baylor multipurpose circulatory support system for short- to long-term use

A multipurpose circulatory support system has been developed as both a temporary and permanent device in total artificial hearts (TAHs) and ventricular assist devices (VADs). The multipurpose concept was derived from the development of a totally implantable electromechanical, one-piece TAH. The blood pump is pneumatically driven in short-term use and is electromechanically driven in long-term or permanent use. Both TAH and VAD versions consist of the same components, except for the actuation mechanism. The common components are a compact pumping chamber with the same configuration, a blood contacting surface biolized with gelatin, a pusher-plate, a Hexsyn rubber diaphragm (University of Akron, Akron, OH) and bovine pericardial valves. Both TAHs and VADs have 63 ml of stroke volume, and the VADs are compact compared with other available investigational device exemption devices. Currently, 1 week survival has been achieved using the electromechanical TAH and 2 week survival using the electromechanimcal VAD without anticoagulation. Results suggest that the currently developed system could be applied in varied patients as a temporary device after cardiotomy, a long-term device for bridge to transplantation, or a permanent device for end-stage heart disease.

Preclinical evaluation of the Kyocera Gyro centrifugal blood pump for cardiopulmonary bypass

The Kyocera Gyro pump has been developed as a completely seal-less centrifugal pump to overcome the problems of the conventional centrifugal pumps. The Gyro pump is a double pivot bearing-supported centrifugal pump with several specific design features, including its eccentric inlet port. We investigated the feasibility of the Gyro pump for cardiopulmonary bypass (CPB) in a bovine model, comparing it with the BioMedicus pump (BP-80). Ten healthy calves (5: Gyro pump, 5: BP-80) underwent 6 h of mildly hypothermic CPB at approximately 33°C. Both pumps provided more than 50 ml/kg/min without any incidents. The haemodynamics of both groups remained stable within the normal range. All haematology and biochemistry data demonstrated no significant differences between the two groups. However, values of plasma-free haemoglobin and lactate dehydrogenase were less throughout the experiments of the Gyro pump than those of the BP-80. To obtain flow equivalent to that of the BP-80, the Gyro pump needed less rotational speeds than the BP-80 (2749.7 ± 233.3 versus 3170.6 ±300.8 rpm, p < 0.05). Less rotational speed in addition to the difference in operating principle may contribute to less blood damage during the CPB of the Gyro pump. After pumping for CPB, no leakage or thrombus formation was observed in either pump. The present study indicated that the Kyocera Gyro pump can be applied as a centrifugal pump for CPB with the same performance as the BP-80 and with relatively less haemolysis than the BP-80.

The Baylor total artificial heart. Flow visualization studies.

To analyze the flow patterns of the left blood chamber of the Baylor total artificial heart (TAH) and to evaluate influences of the inflow valve angle to the flow patterns, flow visualization studies were performed. The inflow valve angle of the left housing was changed by 20 degrees orthogonal to the inflow tube, and comparison studies of the modified and unmodified models were made. For evaluating sectional flow patterns, a laser light was used, the clear transparent housing was scanned segmentally, and flow patterns were recorded on high contrast film for measuring flow velocities. A signal was used that synchronized the timing of the camera shutter to the pusher-plate movement signal. With the modified 20 degree inflow valve direction, there were better closing characteristics of the inflow valve leaflets. At the same time, we could successfully reduce the vortex formation at the inflow port, which may cause thrombus formation. We also have improved the washout during the diastolic phase in not only the bottom area, but in the entire pumping chamber. This flow visualization setup is simple and inexpensive. It is useful not only for validation of global flow patterns, but also for validation of local flow velocities of various blood pumps.

The Baylor-ABI Electromechanical Total Artificial Heart: Accelerated Endurance Testing

To test the durability of each part or assembled component of the Baylor-ABI total artificial heart (TAH), the authors performed an endurance test under severe conditions. The TAH was immersed in a saline bath at 42 degrees C, which is 4-5 degrees C higher than normal body temperature. This is an accelerated endurance test because of the elevated temperatures. In this accelerated endurance test loop, the 42 degrees C heated saline was circulated not only in the pump but also outside the pump. During pumping, temperatures of the motor and outside surface of the centerpiece were continuously measured. This testing showed that during almost 4 months of pumping no electromechanical troubles were observed. Both inside (motor) and outside temperatures were stable and the differences in both temperatures were only 3-4 degrees C, demonstrating that heat generation is not a problem. The voltage and current required in this system remained constant, indicating stable and reliable performance. Based on these results, this pump is expected to run continuously over a long duration in a normal physiologic environment. This accelerated endurance test system is very suitable for estimating the influence of heat generation by the actuator of blood pumps. It is also quite useful in validating the durability of various cardiac prosthesis.

The Baylor Electromechanical Total Artificial Heart

A totally implantable electromechanical total artificial heart (TAH) system has been developed in our institute. This pump is very small (outer diameter, 97 mm; central thickness, 83 mm; and weight, 620 g), demonstrating a good anatomical fit in the pericardial space of 26 heart transplant recipients. The actuation mechanism is simple, and all the components are commercially available with proven longterm durability, thus allowing easier fabrication. The pump can be easily and simply controlled by reliable Hall effect sensors with left master alternate (LMA) mode. Four newly fabricated TAHs demonstrated quite similar pump performances. This TAH has a reproducible high performance with good quality assurance. In vitro performance mapping demonstrated that the pump can provide a maximum flow of 91/ min, with a high sensitivity to preload and a low sensitivity to afterload. During 4 months of accelerated endurance testing in 42°C saline, no electromechanical troubles were observed and power requirement remained constant, indicating a stable and reliable performance. After modification of the inflow valve angle, excellent flow paterns inside the blood chamber were demonstrated in this study, in which laser light and a high-speed camera were used. In vivo feasibility tests were performed successfully in eight calves for up to 1 week, demonstrating the readiness to move forward to longterm in vivo studies. This small, simple, reliable, and durable mechanically driven totally implantable TAH system is suitable for a permanent heart replacement.

Development of a Seal-Less Motor-Driven Centrifugal Blood Pump (Baylor Gyro Pump)

To overcome the seal shaft-related problems of conventional centrifugal blood pumps, a new seal-less centrifugal blood pump capable of more than 2 weeks’ operation was designed by supporting the rotating part of the pump with two pivot bearings. The rotor of a brushless direct current (DC) motor is placed in the inlet side of the pump and is directly connected with the impeller. The blood passes through the gap around the rotor and enters the impeller eye; the rotor impeller rotates as a “gyroscope” in the pump. The pump generated 31/min against 86 mmHg at 2000 rpm. Indices of hemolysis of 0.005 was obtained in hemolysis tests using bovine blood.