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Abstract: A compact eccentric inlet port centrifugal blood pump (C1E3) has been perfected for a long‐term centrifugal ventricular assist device as well as a cardiopulmonary bypass pump. The C1E3 pump incorporates a sealless design and a blood stagnation free structure. The pump's impeller is magnetically coupled to the driver magnet in a sealless manner. The latest hemolysis study reveals that hemolysis is affected by the magnetic coupling distance between the driver and impeller magnet. Furthermore, a floating phenomenon can be observed in a pivot bearing supported pump. Attention was focused on the relationship between the floating phenomenon's characteristics and the magnetic coupling design in the C1E3 pump. Studies were conducted to evaluate the hydromechanical performance in the floating phenomenon. In this study, the relationship between the magnetic coupling design and the floating phenomenon was verified with a smooth spinning condition. The optimized magnetic coupling distance for the floating mode was estimated to be 12 mm for left ventricular assist device and 9 mm for cardiopulmonary bypass pump. Obtaining an optimal spinning condition is required for regulating the magnetic coupling force. To develop a double pivot bearing pump, it is necessary to establish an optimal spinning and/or floating condition and to determine the proper magnetic coupling and magnetic force between the impeller and driver.

Abstract: Mechanical trauma of white blood cells (WBC) due to the operation of a rotary blood pump was examined, using a simple method of trypan blue dye exclusion test for a cell viability measurement. The degree of WBC trauma was investigated using a roller pump (RP) and 3 commercially available centrifugal pumps (Bio‐Medicus [BP], Capiox [CP], Nikkiso [NK]), and compared with the red blood cell (RBC) trauma. Each pump was operated 3 times at a flow rate of 5 L/min against the total pressure head of 350 mm Hg for 6 h in a mock circuit with 400 ml of fresh bovine blood. Blood was sampled at 2 h intervals measuring plasma free hemoglobin concentration and the percentage of damaged WBC in the trypan blue dye exclusion test. Each pump demonstrated a linear increase in the degree of WBC trauma, and there were differences among the tested pumps (RP > BP > CP > NK). These findings were similar to those of the free hemoglobin measurements. To compare the degree of RBC and WBC trauma, the probability (γ,ω) of RBC and WBC to be damaged was calculated, respectively.

Abstract: A double pivot bearing system is adopted for the Gyro C1E3 centrifugal blood pump to achieve a completely sealless structure that prevents blood leakage and thrombus formation around the shaft. The double pivot bearing system is also a critical factor for blood trauma and durability of the C1E3 pump. This study focuses on the double pivot bearing material. The pump with the male ceramic and female polyethylene pivots (PE) was compared with the pump with the male ceramic and female ceramic pivots (CRM), pertaining to stability of the impeller spinning motion, hemolysis, and durability. At first, the wear rate of the pivots was recorded after operating the pumps in various rotational speeds. As for hemolysis, in vitro tests were carried out using fresh bovine blood in 2 conditions (5 L/min, 350 mm Hg and 5 L/min, 100 mm Hg). Then, stability of the spinning motion was investigated by evaluating the vibration of the pump. The two pumps with different female pivots were operated identically at 2,700 rpm, and the vibration signals were measured using an accelerometer that was mounted on the top of the pump housing. The following findings were obtained in this study. The wear sites were different between the PE and CRM. Most of the wear occurred at the top female polyethylene pivot in the PE. In contrast, most of the wear occurred at the top male ceramic pivot in the CRM. In addition, the amount of the initial wear was less and the wear rate was lower in the PE than in the CRM. The hemolysis caused by the PE was less than the hemolysis caused by the CRM. The vibration signals of the PE had less amplitude and a narrower range of frequency than the vibration signals of the CRM. In conclusion, the combination of materials male ceramic‐female polyethyleneare superior to the male ceramic‐female ceramicfor the double pivot bearing system of the Gyro C1E3 centrifugal pump because of less vibration, less hemolysis, and less wear.

AbstractSince 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.

AbstractWe recently proposed a new concept, the total destruction time of erythrocytes, to indicate sublethal damage to erythrocytes by blood pumps. In this article, results of additional experiments concerning this new concept are reported. Five paired in vitro hemolysis tests with bovine blood were conducted using a cone‐type centrifugal pump (Group A) and an impeller‐type pump (Group B). A total pressure head of 100 mm Hg was applied. The factors evaluated were the normalized index of hemolysis and the total destruction time, or the pumping duration, required to raise the level of the plasma‐free hemoglobin to 50% of the total hemoglobin. The morphologic change of the erythrocytes also was analyzed. The percentage of crenated cells was calculated from blood smear specimens 1 min after starting the pumps and 2 h before the total destruction time of Group A in each experiment. Although there was no statistical difference in the normalized index of hemolysis between the two groups, the total destruction time of Group A erythrocytes was significantly shorter than that of Group B (18.9 ± 4.5 h and 33.7 ± 9.9 h in Group A and group B, respectively; p < 2). The rate of crenated erythrocytes was higher in Group A than in Group B at a point 2 h before the total destruction time of Group A. The total destruction time values seem to define a good method for establishing sublethal traumatic damage to erythrocytes in blood pumps.

Abstract: The Gyro C1E3 pump has been developed as a completely sealless centrifugal pump driven by a magnetic coupling system for long‐term usage. The Gyro C1E3 pump is a pivot bearing‐supported pump in which the impeller is supported with the top and bottom pivot bearings. In the Gyro C1E3 pump, the impeller spinning is affected by the force balance between the floating force (Ff[N]) of the hydrodynamic effect and the magnetic thrust force (Tf[N]). The authors quantitatively investigated the floating force of the impeller in vitro to determine the magnetic coupling distance (MCD[mm]) that would result in stable impeller spinning. In vitro tests were performed using a loop filled with 37% glycerin solution to obtain the relationship between the MCDand floating speed (Rf, rotational speed when the impeller starts floating [rpm]) and the relationship between the MCDand TfFrom the obtained relationships, we calculated Ffand determined the relationship between the Ffand the rotational speed (R). Furthermore, we determined the relationship between d(minimum required MCD[mm]) and Rfrom the results of determining the relationship of the MCDand Tfand of the Ffand R. The following relationships were obtained: Rf= 6.24 104.MCD−135; Tf= 5.27.103.MCD‐2.29Ff= 4.71 .10‐‐6RPM1.69; and d= 9.02 .RPM‐085where RPMis the rotational speed. It was demonstrated that the floating force of the impeller is a function only of the rotational speed in the pivot bearing‐supported Gyro C1E3 pump. The floating force is estimated to be 10 N to 40 N at rotational speeds of 1,500 rpm to 3,000 rpm at which the Gyro pump may be used in most clinical situations. It would be possible to control the impeller position of the Gyro pump automatically at the stable spinning condition by controlling the adequate magnetic coupling distance based upon its relationship with the rotational speed which was obtained in this study.

Abstract: The improvement of antithrombogenicity is one of the major objectives for the development of blood pumps. Previously we reported that an in vitro thrombogenic test was useful as a pilot study, especially to predict thrombogenic areas. In this study we modified the method for testing pumps with identical priming volumes by eliminating the blood reservoir. Identical compact mock loops (priming volume of 53 ml. without pump) were constructed and tested with the same priming volume of Nikkiso centrifugal pumps, noncoated verus heparin‐coated. Two pumps were run simultaneously using the same source of fresh heparinized human blood (activated clotting time [ACT] 150–250 s) for 4 or 6 h. Results indicated that the heparin‐coated pump had a longer thrombus free period than the noncoated one. The thrombi location and forms were consistently in the same places the in vivo study had identified. It is suggested that this modified in vitro thrombogenic test is a feasible pilot study, as well as the one previously reported. The minimal priming volume will allow evaluation of multiple pumps simultaneously with the same source blood.

Abstract: To clarify the correlation of vibration and thrombus formation inside a rotary blood pump, 40 preliminary vibration studies were performed on pivot bearing centrifugal pumps. No such studies were found in the literature. The primary data acquisition equipment included an accelerometer (Isotron PE accelerometer, ENDEVCO, San Juan Capistrano, CA, U.S.A.), digitizing oscilloscope (TDS 420, Tektronix Inc., Pittsfield, MA, U.S.A.), and pivot bearing centrifugal pumps. The pump impeller was coupled magnetically to the driver magnet. The accelerometer was mounted on the top of the pump casing to sense radial and axial accelerations. To simulate the 3 common areas of thrombus formation, a piece of silicone rubber was attached to each of the following 3 locations as described: a circular shape on the center bottom of the impeller (CI), an eccentric shape on the bottom of the impeller (EI), and a circular shape on the center bottom casing (CC). A fast Fourier transform (FFT) method at 5 L/min against 100 mm Hg, with a pump rotating speed of 1,600 rpm was used. The frequency response of the vibration sensors used spans of 40 Hz to 2 kHz. The frequency domain was already integrated into the oscilloscope, allowing for comparison of the vibration results. The area of frequency domain at a radial direction was 206 ± 12.7 mVHz in CI, 239.5 ± 12.1 mVHz in EI, 365 ± 12.9 mVHz in CC, and 163 ± 7.9 mVHz in the control (control vs. CI p = 0.07, control vs. EI p < 0.001, control vs. CC p < 0.001, EI vs. CC p < 0.001, CI vs. CC p < 0.001). Three types of imitation thrombus formations were roughly distinguishable. These results suggested the possibility of detecting thrombus formation using vibration signals, and these studies revealed the usefulness of vibration monitoring to detect thrombus formation in a centrifugal pump.

Abstract: An eccentric inlet port is a unique feature of the pivot bearing supported Gyro Compact‐1 Eccentric Inlet Port Model 3 (ClE3) centrifugal pump, a completely seal‐less centrifugal pump. The latest C1E3 has an eccentric inlet port with a 30 degree vertical angle. To investigate the adequacy of this 30 degree angle, flow visualization studies and in vitro hemolysis tests were performed, comparing 4 pumps, each with a different angle of the eccentric inlet port (0, 30, 60, and 90 degrees). The flow visualization study utilizing a tracer method focused on the flow pattern just distal to the inlet port of each pump, and each pump was operated at 5 L/min against 100 mm Hg and 5 L/min against 350 mm Hg. In the pumps with angles of 90 and 60 degrees, the flow direction changed horizontally, causing a vortex formation. In the pump with the 30 degree angle, the inflow did not change its course, resulting in minimal space for vortex formation. In the pump with the 0 degree angle, the inflow collided with the pump housing, resulting in a small vortex formation along the housing surface. The in vitro hemolysis tests at 5 L/min against 350 mm Hg revealed that the pump with the 30 degree angle was the least hemolytic and the pump with the 90 degree angle was the most hemolytic among the 4 pumps. These results suggest that the angle of the eccentric inlet port of the Gyro C1E3 pump should be 30 degrees to have less vortex formation and less red blood cell trauma.

Abstract: Because pump efficiency is closely related to heat generation and blood trauma in a centrifugal blood pump, it is quite important to study pump efficiencies in a variety of conditions. In the present study, pump efficiencies were mapped on the pressure head‐flow rate curves of 4 different pumps; Bio Medicus Bio Pump (BP‐80), Nikkiso (NK), Gyro C1E3, and Gyro PI601 (diameter of the impeller, NK: 50 mm, ClE3: 65 mm, and PI601: 50 mm). The mapping of pump efficiency revealed the following findings. First, the cone type (BP‐80) has less pump efficiency than the impeller type (NK and ClE3); second, the miniaturization of the C1E3 to the PI601 has resulted in an increase in pump efficiency; and third, the diameter of the impeller may contribute to the pump efficiency of an impeller type pump. The mapping of the pump efficiency, as demonstrated in this study, is useful for the analysis of hydraulic pump performance in a wide range of clinically applied conditions.

The double pivot bearings in the Gyro C1E3 centrifugal blood pump incorporate a high-purity alumina (Al2O3) ceramic and an ultra-high-molecular-weight polyethylene (UHMWPE). This centrifugal pump has been developed as a completely sealless pump for long-term usage. The combination of Al2O3and UHMWPE are the materials of choice for the acetabular bearing in artificial joints, which have proven to be clinically reliable for over 10 years. Previous studies have examined the biocompatibility of Al2O3and UHMWPE as bulky implant materials. The present study investigated this material as a blood-contacting material using a standard assessment in vitroand in vivoanalysis. The examined items were systemic toxicity, sensitization (guinea pig maximization test), cytotoxicity (elution test), mutagenicity (Ames test), direct contact hemolysis, and thrombogenicity. The studies were performed according to the United States Pharmacopoeiaand published previous studies. The samples of both Al2O3and UHMWPE demonstrated no differences from the negative controls in all tests. These findings indicate that both Al2O3and UHMWPE are biocompatible materials for double-pivot bearings in the centrifugal blood pump. © 1997 John Wiley & Sons, Inc. J Biomed Mater Res, 36, 381–386, 1997.

Ceramics seldom have been used as blood-contacting materials. However, alumina ceramic (Al2O3) and polyethylene are incorporated into the pivot bearings of the Gyro centrifugal blood pump. This material combination was chosen based on the high durability of the materials. Due to the stagnant flow that often occurs in a continuous flow condition inside a centrifugal pump, pivot bearing system is extremely critical. To evaluate the thombogenicity of pivot bearings in the Gyro pump, this study sought to investigate protein adsorption, particularly albumin, IgG, fibrinogen, and fibronectin onto ceramic surfaces. Al2O3and silicon carbide ceramic (SiC) were compared with polyethylene (PE) and polyvinylchloride (PVC). Bicinchoninic acid (BCA) protein assay revealed that the amount of adsorbed proteins onto Al2O3and SiC was significantly less than that on PVC. The sodium dodecyl sulfate–polyacrylamide gel electrophoresis (SDS-PAGE) indicated that numerous proteins adsorbed onto PVC compared to PE, Al2O3, and SiC. Identification of adsorbed proteins by Western immunoblotting revealed that the adsorption of albumin was similar on all four materials tested. Western immunoblotting also indicated lesser amounts of IgG, fibrinogen, and fibronectin on Al2O3and SiC than on PE and PVC. In conclusion, ceramics (Al2O3and SiC) are expected to be thromboresistant from the viewpoint of protein adsorption. © 1998 John Wiley & Sons, Inc. J Biomed Mater Res, 40, 24–30, 1998.

Abstract: The compact eccentric inlet port (ClE3) centrifugal blood pump was developed as a cardiopulmonary bypass (CPB) pump. The C1E3 pump incorporated a seal‐less design with a blood stagnation free structure. The pump impeller was magnetically coupled to the driver magnet in a sealless manner. To develop an atraumatic and antithrombogenic centrifugal pump without a shaft seal junction, a double pivot bearing system was introduced. Recently, a mass production model of the C1E3 was fabricated and evaluated. The ratio of the normalized index of hemolysis (NIH) of the C1E3 was 0.007 g/ 100 L, in comparison to the NIH of the BP‐80, 0.018 g/ 100 L, each in a CPB condition of 5 Limin against 325 mm Hg. Both pumps were compared in identical in vitro circuits. To further evaluate the pumps during cardio pulmonary bypass for reliability and function, 6 h of CPB was performed on each of 8 bovines using either the C1E3 or BP‐80 centrifugal pump. The BP‐80 and C1E3 provided pump flows of 5MO ml/kg/min without incident. The hemodynamics were stable, and the hematology and biochemistry data were within normal ranges. There were no statistically significant differences between the 2 groups. Concerning the plasma free hemoglobin values. a mass production model of the C1E3 pump had the same hemolysis levels as the BP‐80. Our preliminary studies reveal that the C1E3 pump is reliable. Also, the C1E3 will satisfy clinical requirements as a cardiopulmonary bypass pump.

Abstract: During a particular long‐term in vitro hemolysis test, the plasma free hemoglobin suddenly increased even though the hemolysis level had risen linearly for the previous several hours. This phenomenon was dubbed the total destruction of erythrocytes (TDE) phenomenon, and it was hypothesized that this was the result of the accumulation of sublethal damage to erythrocytes. It was suggested that the TDE might demonstrate the hemolytic characteristics of a pump more sensitively than a conventional hemolysis test. However, the previous report did not consider the effects of temperature or contamination. To study these effects, 3 long‐term hemolysis tests were concluded under the following conditions. For Study 1 blood temperature was maintained at 27°C (n = 2); for Study 2, at 37°C (n = 4); and for Study 3, at 37°C with gentamicin (n = 4). The BioMedicus and Nikkiso pumps were used as they were in our previous report. Gas sterilization of all circuits and pumps preceded experimentation. In Studies 1 and 3, hemolysis increased linearly for 29 h. However, in Study 2 a sudden increase of hemolysis occurred for both pumps. Possible causes of this were the dramatic changes in environmental factors such as severe acidosis, high 0, and glucose consumption, and CO2accumulation. In contrast, neither Study 1 nor Study 3 showed a sudden increase in hemolysis. The plasma free hemoglobin increased linearly in both groups until 29 h of pumping. The environmental changes resulting from contamination were considered to be the cause of the sudden increase in hemolysis. In conclusion, the TDE did not reflect mechanical blood cell damage, but rather different environment situations. Hemolysis increased linearly up to 29 h in either 27°C or germ‐free conditions.

Abstract: The present study investigates how the surface roughness of an impeller affects hemolysis in the pivot bearing supported Gyro C1E3 pump. This study focuses on particular areas of the impeller surface in the impeller type centrifugal pump. Seven Gyro C1E3 pumps were prepared with smooth surface housings and different impeller parts with different surface roughnesses. The vanes, top side, and backside of the impeller were independently subjected to vapor polishing, fine sand blasting, or coarse sand blasting to produce three different grades of surface roughness. These surfaces were then examined by a surface profile instrument. Using these pumps with different impellers, in vitro hemolysis tests were performed simulating cardiopulmonary bypass (5 Wmin, 350 mm Hg). The findings of this study conclusively proved that surface roughness of the back side of the impeller has the greatest effect on hemolysis, followed by the top side and then the vanes. The following are reasons for these findings. First, the shear rate may be greater on the back side than on the top side because of the smaller gap between the back and the housing and the greater relative speed against the impeller. Second, the fluid beneath the impeller may have a longer exposure time because there is little chance for the fluid to mix beneath the impeller. Third, the shear rate may be greater on the top side of the impeller than on the vanes because a vortex formation occurs behind the vanes.

Abstract: While a centrifugal pump is generally used for nonpulsatile blood flow, it can also produce a pulsatile flow by alternating the impeller rotational speed (rpm) periodically. However, there is concern that this centrifugal pump pulsatile mode may induce added hemolysis as a result of the repeated acceleration and deceleration of rpm. Thus, a hemolysis study of the pulsatile modes of the Gyro C1E3 centrifugal pump (Gyro‐P) was conducted. The results were then compared with the nonpulsatile mode of the same Gyro pump (Gyro‐N) and the nonpulsatile BioMedicus BP‐80 (Bio‐N) pump. Three different conditions were simulated: left ventricular assist device (LVAD), cardiopulmonary bypass (CPB), and percutaneous cardiopulmonary support (PCPS). The beating rate of the Gyro‐P was set at 40 bpm, with repetition of 2 different impeller speeds (the lower rpm being 70% of the higher speed). The 2 impeller speeds were set to obtain the same average flow as that of the nonpulsatile mode. The hemolysis results of the Gyro‐P were comparable to or better than those of the Bio‐N, and no excessive hemolysis was observed, compared to the Gyro‐N. In conclusion, the Gyro‐P had an excellent hemolytic characteristic and generated no excessive hemolysis in most clinical usage conditions. With the concern of hemolysis eliminated, this pulsatile mode may have various possible advantages.