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We 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; p0.02). 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.

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.

The blood contacting surface quality is an important pump parameter for blood compatibility and cell damage. This study investigates the surface roughness and the effect it has on hemolysis in a centrifugal blood pump. In vitro hemolysis tests were performed with a pivot bearing supported Gyro centrifugal pump (C1E3) simulating cardiopulmonary bypass (CPB; 5 L/min, 350 mm Hg) and left ventricular assist device (LVAD; 5 L/min, 100 mm Hg) conditions. To produce 4 different grades of surface roughness, the impellers and housings were subjected to vapor polishing, sand papering, fine sand blasting, or coarse sand blasting. Seven pumps were assembled with different impeller and housing surfaces. These surfaces were then examined by a surface profile instrument and a scanning electron microscope. The results of this study are as follows. First, the effect of surface roughness on hemolysis was significantly greater in the CPB condition than in the LVAD condition. Second, surface roughness, regardless of whether it is the impeller or pump housing, had little effect on hemolysis in the LVAD condition. Third, in the CPB condition, the surface roughness of the pump housing has a greater effect on hemolysis than does that of the impeller. From a hemolytic point of view, an extremely smooth pump housing is required for use of an impeller type centrifugal pump as a CPB device. In contrast, it is conceivable that a smooth surface is not always essential for an impeller type centrifugal pump that is used as an LVAD.

A seal-less centrifugal pump aiming for long-term circulatory support has been developed. In this model, shaft seals that cause thrombus formation and blood leakage were eliminated. A brushless direct current motor was incorporated as a driving unit, and pivot bearings were used to support the impeller. With reference to its motor-driven system, this pump was named the M-Gyro Pump. The first model (M1) yielded an index of hemolysis of 0.005 g/100 L using bovine blood and demonstrated satisfactory performance as a right heart assist for 2 days (4 L/min, 60 mm Hg, 1,800 rpm). The second model (M2) has been developed for left heart assist by employing a stronger motor. The pump capacity was improved to 6 L/min against 240 mm Hg at 1,800 rpm, but significant heat generation was observed. By optimization of motor efficiency, the M2 model can be improved to meet the requirements of a pump for left heart assist.

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.

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 (gamma, omega) of RBC and WBC to be damaged was calculated, respectively. gamma = delta DRBC/delta N, omega = delta DWBC/delta N where DRBC and DWBC are the ratios of the damaged RBC and WBC, respectively, and N is the passing number defined as Qt/V (Q, flow rate; t, time; V, circulating volume). The data of this study demonstrated that the omega value was approximately 20 times or more greater than the gamma equally in all the tested pumps. This suggests that a WBC is more vulnerable to mechanical damage by a rotary blood pump than a RBC.

Centrifugal blood pumps are used widely for cardiopulmonary bypass, as ventricular assist devices, and for extracorporeal membrane oxygenation (ECMO). However, there is no centrifugal blood pump that is suitable for long-term ECMO. The authors developed the Gyro C1E3 centrifugal blood pump (Kyocera Corporation, Kyoto, Japan), which has superior antithrombogenic, antitraumatic, and hydraulic features in comparison with the conventional centrifugal blood pumps. Five ex vivo long-term durability tests of the Gyro C1E3 were performed using healthy miniature calves. The ECMO circuit was composed of a prototype hollow fiber silicone membrane oxygenator and a Gyro C1E3 pump. Venous blood was drained from the left jugular vein of a calf, passed through the oxygenator and infused into the left carotid artery using a Gyro C1E3. Ex vivo studies were performed from 7 to 15 days at a blood flow rate of 1 L/min. During this period, the Gyro C1E3 demonstrated a stable performance without exchanging the pump. Bleeding complications were the major reason for termination of each experiment. Rotational speed was maintained around 2,000 rpm. All five calves demonstrated neither abnormal signs nor abnormal blood examination data throughout the experiment. Neither clot nor thrombus formations were found during the necropsy in the cannula or pump nor were infarctions observed in any of the major organs. In conclusion, the Gyro C1E3 showed a stable and reliable performance during long-term ex vivo bovine experiments under the conditions tested.

A totally implantable centrifugal artificial heart has been developed in which a pivot bearing supported centrifugal pump is used as a blood pump. The following have been adopted as blood contacting materials in our pump: titanium alloy (Ti-6A1-4V) for the housing and impeller, alumina ceramic (Al2O3) for the male pivots, and ultrahigh molecular weight polyethylene (PE) for the female pivots. Greater antithrombogenicity is required for an implantable blood pump. To examine the thrombogenicity of these materials, we evaluated in vitro platelet adhesion and activation, which may play key roles in thrombogenesis on foreign surfaces. Ti-6A1-4V, Al2O3, and PE were compared with polycarbonate (PC), silicone carbide (SiC), and pure titanium (pTi). Platelet adhesion was assessed using monoclonal antibody (CD61) directed against glycoprotein IIIa. Platelet activation was evaluated by measuring P-selectin (GMP-140) released from irreversibly activated platelets. Each material with a surface area of 16.6 cm2 was incubated with 2.5 ml of plasma or 2.5 ml of heparinized fresh whole blood for 3 h at 37 degrees C. The optical density (OD) at a wavelength of 450 nm for CD61 was 0.93+/-0.35 in PC, 0.34+/-0.13 in PE, 0.27+/-0.13 in pTi, 0.26+/-0.01 in Al2O3, 0.21+/-0.04 in SiC, and 0.12+/-0.12 in Ti-6A1-4V. The GMP-140 levels of the tested materials were not significantly different from the control value (45.9+/-7.2 ng/ml). These results indicate that Al2O3, PE, and Ti-6A1-4V, which are incorporated into our implantable centrifugal pump, have satisfactory antithrombogenic properties in terms of platelet adhesion. However, platelet activation by any material was not observed under the static condition in this study.

Surface roughness of a blood pump is an important factor for blood cell damage. This study investigated the effect of surface roughness pertaining to hemolysis in a centrifugal pump. In vitro hemolysis tests were performed under car-diopulmonary bypass (CPB; 5 L/min, 350 mmHg) and left ventricular assist device (LVAD; 5 L/min, 100 mmHg) conditions using the pivot bearing supported Gyro centrifugal pump (C1E3). Seven types of pumps with impellers and housings with different surface roughness were prepared as follows: vapor polish (VP) housing and VP impeller; VP housing and sandpaper (SP) impeller; VP housing and fine sandblasting (FSB) impeller; VP housing and coarse sandblasting (CSB) impeller; SP housing and VP impeller; FSB housing and VP impeller; and CSB housing and VP impeller. The results revealed that 1) the effect of surface roughness on hemolysis was significantly larger with CPB than LVAD; 2) surface roughness, regardless of the impeller or housing, had little effect on hemolysis with LVAD; and 3) during CPB, the surface roughness of the pump housing had a larger effect on hemolysis than did that of the impeller. In conclusion, from a hemolytic point of view, it is likely that an extremely smooth pump housing is required for an impeller centrifugal pump for CPB. However, it is likely that a smooth surface is not as essential for this impeller centrifugal pump as for an LVAD.

Pump power loss is defined as input power that is not used for the output work of the pump. Less pump power loss means a higher pump efficiency. A common opinion is that the pump power loss is closely related to heat generation of the pump, which may affect not only the endurance of pump materials, but also blood damage in a blood pump. In this study, the relationship between pump power loss and heat generation in centrifugal blood pumps was investigated using the pivot-bearing supported Gyro C1E3 pump (C1E3) and Bio-Medicus pump (BP-80) under four different total pressure heat/flow conditions. A single special torque measuring driver motor was used for operating both the C1E3 and BP-80 in the four conditions. The pump power loss was calculated from the measured motor torque and hydraulic power. The changes in blood temperature were measured while the pump was operated at room temperature (25 degrees C) to obtain the following findings: First, the C1E3 caused less pump power loss and less temperature increase in blood than the BP-80 in all clinical simulated conditions that were tested; and second, the pump power loss and heat generation had a linear correlation with temperature rise from 22 to 25 degrees C in both the C1E3 and BP-80. During this period, approximately 30% of the pump power loss was transformed to heat, independent of the centrifugal blood pump type, provided that heat conduction through the pump housing and tubing was negligible during this particular period.

To estimate the lifetime of the pivot bearing system of the sealless centrifugal Gyro C1E3 pump, pivot bearing wear phenomena of the C1E3 were studied. The pivot bearing system consisted of a male and female pivot made of ceramics and ultrahigh molecular weight polyethylene (UHMWPE), respectively. First, many pumping tests were performed with the C1E3 under various pumping conditions, and the effects of impeller position and fluid on wear were analyzed. Through these preliminary tests, it was found that the wear progress of the pivot bearing consisted of initial wear and stationary wear. Most of this initial wear is caused by the plastic deformation of the polyethylene female pivot. It also was observed that bovine blood was almost comparable to water in its effect on the stationary wear rate at the same rotational speed. Based on these results, a long-term pumping test was performed with the C1E3, and initial and stationary wear rates were determined. At the same time, the maximal loosening distance (LDmax) (permissible total wear) of the C1E3 was determined experimentally from hemolytic and hydraulic performance perspectives. By using experimentally determined parameters the lifetime of the pivot bearing system of the C1E3 pump was estimated for various pumping conditions. The lifetime of the pivot bearing system of the C1E3 was typically 10 years for right ventricular assist, 8 years for left ventricular assist, and 5 years for cardiopulmonary bypass.

Blood trauma is one of the important performance parameters of centrifugal pumps. To investigate the blood trauma induced by these pumps, in vitro hemolysis tests have become an important procedure and are increasingly used for pump development and comparisons. The Baylor compact eccentric inlet port (CIE) centrifugal blood pump was developed as a long-term centrifugal ventricular assist device (VAD) as well as a cardiopulmonary bypass pump (CPB). The Baylor CIE pump incorporates a seal-less design with a blood stagnation-free structure. This pump can provide flows of 5 L/min against 350 mm Hg of total pressure head at 2,600 revolutions per minute. The pump impeller is magnetically coupled to the driver magnet in a seal-less manner. The latest hemolysis study revealed that hemolysis may be affected by the gap distance between the driver and the impeller magnet. The purpose of this study was to verify the effect of the magnetic coupling distance on the normalized index of hemolysis (NIH) with the CIE model and to obtain an optimal gap distance. The NIH value was clearly decreased by alteration of the magnetic coupling distance from 7.7 to 9.7 mm in CPB and left ventricular assist device (LVAD) conditions. The NIH, when using the pump as an LVAD condition, was reduced to a level of 0.0056 from 0.095 when the magnetic coupling distance was extended. The same results were also obtained when the pumps were used in a CPB condition. The magnetic coupling distance is an important factor for the CIE model in terms of hemolysis. Different coupling forces effect the bearings and impeller stability. These results suggest that an optimal driving condition with a proper magnetic coupling and an optimal force between the impeller and driver is necessary to develop an atraumatic centrifugal pump.

To date an index of hemolysis is the only parameter to evaluate in vitro the hemolytic properties of blood pumps. However, this index does not reflect the sublethal conditions of erythrocytes. In this paper, a new concept, the total destruction of erythrocytes, to indicate traumatic features on erythrocytes is proposed. Five paired long duration in vitro hemolysis tests were conducted using the BioMedicus pump; BP80, and the Nikkiso pump, HMS12. The pumps ran until either a sudden change in blood color to dark red was noted or the pumps ran for over 24 h. At a certain point, the plasma-free hemoglobin levels suddenly and dramatically increased in each experiment except one Nikkiso case. At a certain point in time, the destruction of most erythrocytes suddenly and simultaneously occurred. We call this phenomenon total destruction of erythrocytes and define the pumping duration required to raise the level of the plasma-free hemoglobin to 50% of the total hemoglobin as total destruction time. Although there is no statistical difference in the normalized index of hemolysis between the two pumps, the total destruction time of the BioMedicus pump is significantly shorter than that of the Nikkiso pump. It appears that an accumulation of sublethal damage on erythrocytes resulted in the decrease of the hemolytic threshold of the entire erythrocyte and also resulted in a sudden entire destruction of erythrocytes.

The effect of hematocrit (Ht) on in vitro hemolysis test results (i.e., index of hemolysis) was evaluated using a Baylor/NASA prototype axial flow pump. Red blood cell suspensions of six different Ht (5, 10, 15, 20, 30, 40%; n = 30) were prepared and used for this evaluation. The pump was operated for 60 min under 5 L/min flow conditions, and blood samples were taken every 10 min to measure plasma free hemoglobin levels. The normalized index of hemolysis (NIH) was calculated using the regression line slope between time and plasma free hemoglobin level, and relationships between NIH and Ht or hemoglobin (Hb) were checked. NIH and Ht had a statistically significant (p < 0.0001) correlation with a coefficient of fit of 0.976, and NIH and Hb had a statistically significant (p < 0.0001) correlation with a coefficient of fit of 0.976. To reduce the effect of Ht, NIH/Ht was proposed and compared with a modified index of hemolysis (MIH), which was normalized by the Hb level of blood. NIH/Ht and MIH had a poor correlation with Ht (coefficient of fit, 0.608) and Hb (coefficient of fit, 0.577), respectively. When blood that has a wide range of Ht or Hb values is used for in vitro hemolysis tests, NIH/Ht is suggested for use as an index of hemolysis to evaluate the hemolysis characteristics of rotary blood pumps because MIH has no dimension and it requires Hb values. In contrast, NIH/Ht has a dimension of g/100 L, which is quite understandable, and it does not require measurement of Hb levels of blood; it is therefore cost-effective.

The Baylor C-Gyro Pump Eccentric Inlet Port Models (C1E) have been developed aiming for a long-term centrifugal ventricular assist device (VAD) as well as a cardiopulmonary bypass pump. The eccentric inlet port models are characterized by their unique inlet port and secondary impeller vanes. An inlet female pivot bearing, which was fixed to a supporting bar in the prototype model, is directly embedded into the ceiling of the pump casing. An inlet port is then placed off-center to avoid the bearing area, and it is angled between 0 to 90 degrees from the upright position. In addition, small secondary vanes were incorporated into the impeller bottom to accelerate the washout flow behind the impeller. These features attained design objectives proposed for higher antithrombogenicity: a seal-less pump chamber, no stationary parts in the blood path, and acceleration of the secondary flow behind the impeller. The first in vivo experiment using C1E pumps showed excellent antithrombogenicity for up to 18 days when the experiment ceased due to severe infection in the calf.

Properly planned in vitro and in vivo studies are mandatory to validate blood pump performance. However, standard procedures for in vitro and in vivo tests of total artificial heart (TAH) performance still do not exist. At Baylor College of Medicine, standard tests procedures for performance validation of the totally implantable TAH have been established. In this paper, these in vitro tests protocols (performance mapping tests, accelerated endurance test, hemolysis test, flow visualization tests, etc.) are described as well as in vivo test procedures (TAH implantation procedure, including surgical technique, postoperative management and tests, etc.). In addition, pathological protocols are presented. In our experience, these procedures are very simple, easy to perform, and inexpensive. These protocols are proposed as standard in vitro and in vivo tests for a TAH.

We have developed a compact, seal-less, all-purpose centrifugal pump, the Baylor C-Gyro pump, which is intended as a long-term ventricular assist device (VAD) as well as a cardiopulmonary bypass pump. In attaining this goal, we began with eliminating the shaft seals by adopting a pivot bearing system at the impeller shaft. In addition, a ring magnet encased in the bottom of the impeller was coupled magnetically to a driver magnet placed outside the pump housing (C1 Prototype). This first model yielded satisfactory performance in vitro with a flow rate of 8 L/min against 250 mm Hg at 2,400 rpm, and an index of hemolysis (IH) of 0.0083 g/100 L using bovine blood. In the second model, the C1 Eccentric Inlet Port Model, the inlet bearing support bar in the prototype were eliminated without reducing the prototype's performance. These designs for antithrombogenicity are being tested by the first in vivo experiment, which has lasted for more than 2 weeks.

The Gyro pump has a double pivot bearing system to support its impeller. In this study, the integrity of the bearing system was examined after ex vivo studies. The pumps were implanted into calves and evaluated for different periods as a paracorporeal left ventricular assist device (LVAD). One pump was subjected to a test of 30 days, 1 for 15 days, 4 for 14 days, 1 for 10 days, 1 for 7 days, 2 for 4 days, and 4 for 2 days. One additional pump was subjected to percutaneous cardiopulmonary support (PCPS) condition for 6 days (total pressure head 500 mm Hg with a pump flow rate of 3 L/min). The anticoagulation treatment consisted of a continuous administration of heparin to maintain an achieved clotting time (ACT) of 200–250 s during the LVAD study and 250–300 s during the PCPS study. After the experiment, the pumps were disassembled, and the wear and deformation of male and female bearings were analyzed. There were no dimensional changes on male bearings but there were on female bearings. Wear and deformation of the female bearings were calculated as follows: wear and deformation = (depth of female before pumping) − (depth after pumping). Thirteen assembled Gyro pumps were disassembled to measure the depth of the female bearings before pumping. There was no statistical relationship between the wear and deformation and the motor speed × driving period. From these results, the deformation was not due to wear but to the creep or elastic deformation. This study suggested that the double pivot bearing system of the Gyro pump is highly durable.

The pivot bearing-supported Gyro C1E3 centrifugal pump is driven by magnetic coupling. The magnetic coupling distance (MCD) between the impeller magnet and the driver magnet affects both hydraulic performance and hemolysis. Although a greater MCD causes less hemolysis, it increases the risk of decoupling of the impeller magnet. Therefore, it is important to consider the effect of the MCD on both hemolysis and decoupling when the C1E3 pump is applied in various circulatory assist conditions. This study investigates the effect of the MCD on decoupling in a C1E3 pump that is driven by the Nd-Fe-B composite ring-shaped magnets. The results will determine which MCD is the most practical in all assist device conditions. The MCD of the C1E3 pump was varied from 9.5 to 14.5 mm by inserting spacers between the bottom pump housing and the driver magnet. At a rotational speed just before the decoupling occurred, the flow rate and total pressure head were measured. The results revealed that a MCD between 9.5 and 14.5 mm was enough to produce a flow rate of more than 10 L/min without decoupling, and a MCD of less than 11.5 mm was required when the total pressure head was more than 500 mm Hg. Thus, the limiting factor for the MCD of the C1E3 pump is the total pressure head rather than the flow rate. An MCD of less than 11.5 mm is required to prevent decoupling of the impeller of the C1E3 pump with the specific Nd-Fe-B magnets in the full range of clinical circulatory assist conditions.

The Gyro C1E3 is a centrifugal blood pump. Its antithrombogenic and antitraumatic blood features were demonstrated by prior studies. Based upon these studies, a mass production model of the C1E3 is becoming commercially available. Therefore, this feasibility study was conducted using the mass production models of the Gyro C1E3 for long-term cardiac assist in ex vivo animal experiments. Five healthy calves were used and 15 pump heads were applied for different time periods (Group 1, 30 days; Group 2, 14 days; Group 3, 10 and 7 days; Group 4, 4 days; and Group 5, 2 days). Activated clotting time (ACT) was kept at 200-250 sec. All five calves demonstrated neither abnormal signs nor abnormal blood examination data throughout the experiment. During necropsy, no thromboembolism was found in any downstream organs. Groups 1-4 showed thrombi inside the pump heads while two pumps in Group 5 had no thrombi formations. Bearing deformation or possible wear did not increase after 2 days of pumping. The C1E3 is capable of long-term assist circulation. However, after 2 days of pumping, careful observation is necessary since thrombi may occur inside the pump when ACT is controlled under 250 sec. During the weaning stage or low flow (under 2 L/min), over 250 sec of ACT is recommended to assure the safety of the patient.

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.

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 MCD and floating speed (Rf, rotational speed when the impeller starts floating [rpm]) and the relationship between the MCD and Tf. From the obtained relationships, we calculated Ff and determined the relationship between the Ff and the rotational speed (R). Furthermore, we determined the relationship between d (minimum required MCD [mm]) and R from the results of determining the relationship of the MCD and Tf and of the Ff and R. The following relationships were obtained: Rf = 6.24 x 10(4) x MCD-1.35; Tf = 5.27 x 10(3) x MCD-2.29; Ff = 4.71 x 10(-6) x RPM1.69; and d = 9.02 x RPM-0.85 where RPM is 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.

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.

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.

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 degrees C (n = 2); for Study 2, at 37 degrees C (n = 4); and for Study 3, at 37 degrees 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 O2 and glucose consumption, and CO2 accumulation. 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 degrees C or germ-free conditions.

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.

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 polyethylene are superior to the male ceramic-female ceramic for the double pivot bearing system of the Gyro C1E3 centrifugal pump because of less vibration, less hemolysis, and less wear.

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.

Centrifugal blood pumps are playing a key role in circulatory mechanical assist systems including cardiopulmonary bypass (CPB), right and left ventricular assist devices (RVAD and LVAD), percutaneous cardiopulmonary support (PCPS), and extracorporeal membrane oxygenation (ECMO). Each of these circulatory assist systems requires specific flow and pressure conditions. In vitro hemolysis tests were performed using five compact mock loops with flow and pressure set equivalent to clinical conditions. These studies determined the hemolytic characteristics and clinical applicability of the pivot bearing-supported Gyro centrifugal pump with an eccentric port (C1E3) compared with the Bio-Medicus pump (BP-80). Normalized index of hemolysis (NIH) values of the C1E3 were less than those of the BP-80 under all conditions; in particular, they were significantly less in the CPB, LVAD, and RVAD conditions. In addition, linear correlation was observed between NIH values, rotational pump speed (RPM), total pressure head (delta P), and flow rate (Q) with both the C1E3 and BP-80: NIH = a(RPM/Q) + b, NIH = c(delta P/Q) + d. However, the slopes (a and c) of these equations were smaller with the C1E3 than those with the BP-80, which suggests that the C1E3 has decreased hemolytic characteristics when increasing the RPM and delta P. In other words, the increase of RPM and delta P results in less shear stress with the C1E3 than with the BP-80. One cause of these decreased hemolytic characteristics of the C1E3 is thought to be less pump power loss against an increase of RPM and delta P than with the BP-80. Furthermore, the average exposure time is shorter with the C1E3 than with the BP-80 because the priming volume of the C1E3 (30 ml) is smaller than that of the BP-80 (80 ml). From the point of both shear stress and exposure time, the C1E3 has less hemolytic features than the BP-80.

The pivot bearing centrifugal blood pump was developed as a long-term centrifugal ventricular assist device (VAD) as well as a cardiopulmonary bypass pump. This pivot bearing supported centrifugal pump with an eccentric port (CIE) incorporates a seal-less design with a blood stagnation-free structure. This pump can provide flows of 12 L/min against 650 mm Hg total pressure head at 3,600 rpm, and in a CPB condition 5 L/min against 350 mm Hg total pressure head at 2,600 rpm. Very recently, the pivot bearing system was modified to obtain a stable and smooth spinning movement. The material of the female pivot was changed from ceramic to polyethylene. Three kinds of bearings were tested simultaneously with bovine blood in two types of in vitro circuits to determine the blood damage from the bearings. Pressure differences across the pump (total head pressure, delta P) of 140 mm Hg (n = 12) and 330 mm Hg (n = 12) were examined. The normalized index of hemolysis (NIH) was slightly higher in a ball bearing (BB) pump than in a polyethylene bearing (PB) pump and statistically higher than the BioMedicus Pump (BP-80) on delta P of 140 mm Hg. When the delta P was at 330 mm Hg, a comparison between the three types of pumps revealed no difference in NIH. In addition, the primary vane of the impeller was redesigned to obtain an atraumatic structure. In the second study (n = 14), there was no difference in the NIH between BP-80 and the current model when the delta P was 300 mm Hg (0.019 +/- 0.002 vs. 0.027 +/- 0.006, p = 0.3) and/or when the delta P was 100 mm Hg (0.0008 +/- 0.0001 vs. 0.0014 +/- 0.0002, p = 0.07). The modified pivot bearing had an improved spinning condition and no change in hemolysis. A proper selection of pivot bearing materials is important to develop an atraumatic centrifugal pump. The modification of the bearing system and redesign of the vane enabled a compact centrifugal pump to become a reality.

Recently, a newly developed centrifugal pump, the Baylor-Nikkiso pump, was approved for clinical use in the United States. This pump is the most compact centrifugal pump with a priming volume of only 25 ml. Although it is small, this pump can provide a flow of 4 L/min against a total pressure head of 300 mm Hg at 3,000 rpm. In vitro and in vivo validation of the Baylor-Nikkiso pump has proved that this pump could effectively reduce blood trauma even under high total head pressure. In addition, 48-h durability tests with biventricular bypass using calves verified the reliability of shaft sealing and anti-thrombogenicity. Clinical trials of the Baylor-Nikkiso pumps have been initiated in our department. This pump provides flows of 60–70 ml/kg/min with stable hemody-namic conditions. No leakage or thrombus formation was observed. The results of the initial clinical experience of the Baylor-Nikkiso pump suggest that it is suitable for cardiopulmonary bypass surgery.

To obtain an optimal design of the left blood chamber of the total artificial heart (TAH), flow visualization studies were performed. Information on velocities in critical areas of the left chamber was gathered using sectional pulsed laser light. The flow patterns on the entire pumping duration were photographed frame by frame. The inflow port, the opposite of the inflow and outflow of the pump (bottom area), and the diaphragm/ housing junction were the focal areas. The pump conditions, such as chamber pressure, preload and afterload pressure, pumping rate and roller screw, and displacement were recorded. Major stagnations and a low washout effect were observed in the bottom region. The closing of the inflow valve was irregular. In order to solve this problem, the inflow valve angle was changed 20 degrees. A comparison study showed a better valve closing characteristic, and no stagnation areas were observed with this new valve angle. Various velocity profiles confirmed the results. The valve closing characteristic is described in relationship to back flow.

A multipurpose miniature electromechanical energy system has been developed to yield a compact, efficient, durable, and biocompatible total artificial heart (TAH) and ventricular assist device (VAD). Associated controller-driver electronics were recently miniaturized and converted into hybrid circuits. The hybrid controller consists of a microprocessor and controller, motor driver, Hall sensor, and commutation circuit hybrids. The sizing study demonstrated that all these components can be incorporated in the pumping unit of the TAH and VAD, particularly in the centerpiece of the TAH and the motor housing of the VAD. Both TAH and VAD pumping units will start when their power line is connected to either the internal power pack or the external battery unit. As a redundant driving and diagnostic port, an emergency port was newly added and will be placed in subcutaneous location. In case of system failure, the skin will be cut down, and an external motor drive or a pneumatic driver will be connected to this port to run the TAH. This will minimize the circulatory arrest time. Overall efficiency of the TAH without the transcutaneous energy transmission system was 14-18% to deliver pump outputs of 4-9 L/min against the right and left afterload pressures of 25 and 100 mm Hg. The internal power requirement ranged from 6 to 13 W. The rechargeable batteries such as NiCd or NiMH with 1 AH capacity can run the TAH for 30-45 min. The external power requirement, when TETS efficiency of 75% was assumed, ranged from 8 to 18 W. The accelerated endurance test in the 42 degrees C saline bath demonstrated stable performance over 4 months. Long-term endurance and chronic animal studies will continue toward a system with 5 years durability by the year 2000.

A new index "loss factor Z" defined by Eq. 1 was introduced as the absolute expression of the mock loop resistance for testing a nonpulsatile pump. [formula: see text] where gamma is specific gravity of the fluid, g is the acceleration of gravity, delta P is total pressure head, and Q is flow. Z is expected to be constant, regardless of the pumping parameters. Z values obtained in the same mock loop but with different rotary blood pumps were almost identical and were defined as Z0. New methods of analysis of the flow-restrictive conditions of various rotary blood pumps are proposed in this paper: namely, differential loss factor delta Z, and loss factor sensitivity delta Z/delta A. The proposed Z-Q curves demonstrated better performance mapping than the conventional delta P-Q curves. Delta Z is the difference between the Z-Q curves of two different pumps. A is a design parameter of the pump; therefore delta Z/delta A is a quantitative expression of the effect of the design change on the hydraulic performance. These various indices were used to analyze the internal hydraulic loss of a centrifugal pump (Gyro pump). The relationship between its gap size (rotor casing) and hydraulic performance was assessed quantitatively by these indices. In this paper, the derivation processes and above-mentioned indices are described.

Thermal management of the implantable ventricular assist system (VAS) is important not only from the pathophysiological point of view but also from the standpoint of system endurance. The heat distribution within the Baylor VAS was measured using different motor housing materials and environmental conditions. The temperature of the circulating water in the mock loop was set at 37 degrees and 42 degrees C. A polycarbonate motor housing was not a suitable material because of the high temperature development in the actuation system. An anodized aluminum housing demonstrated excellent heat conductivity. The surface temperature of this motor housing was 41.6 degrees C when immersed in circulating water at 42 degrees C. Heat conduction from the motor to the circulating blood revealed an effective thermal path. In the worst case, the heat flux of the motor to the circulating blood revealed an effective thermal path. In the worst case, the heat flux of the motor housing was calculated to be less than 0.062 W/cm2--an acceptable level for the surrounding tissues.

To analyze the flow patterns of the left and right blood chambers of the total artificial heart (TAH), flow visualization studies were performed. Two setup levels were used for the flow visualization studies. For estimating the global flow patterns, the pumps were illuminated using incandescent light, and the patterns were recorded by either videotape or photography. To evaluate sectional flow patterns, a laser light was applied, and the pump could be scanned segmentally. The flow patterns were recorded by a high-speed camera. A signal was also used that synchronized the timing of the camera shutter to the pusher-plate movement signal. In the left pump chamber, major stagnations were observed in the middle area of the inflow site. To solve this problem, a modification was made that changed the inflow direction appropriately. After evaluation of the inflow port direction, a proper flow pattern was obtained, which was validated by a global flow visualization study. Furthermore, both pump chambers indicated excellent flow patterns as obtained by a segmental flow visualization study method utilizing a laser light. The Baylor TAH demonstrated excellent flow patterns in flow visualization studies, with antithrombogenicity expected. These flow visualization studies are very useful not only for validations of global flow patterns but also for validations of local areas of stagnation in various blood pumps.

The proper design of a left ventricular assist device (LVAD) requires an understanding of the pump's fluid dynamic and biocompatible properties. A hydraulically efficient system minimizes the power required for pumping. Biocompatibility refers to the ability to pump blood with minimal hemolysis and thrombus formation. Typically, shear stresses below a threshold level will not damage blood significantly. A fluid dynamic analysis of a prototype centrifugal pump designed for use as an LVAD was performed to establish flow characteristics. A flow visualization technique using Amberlite particles suspended in a glycerin/water blood analogue was used. The system was illuminated with a 1 mm planar beam strobed helium-neon laser, and the results were recorded photographically. An analysis of photographs revealed laminar and turbulent flows with vortices within an illuminated plane in both the inlet and outlet port areas. From these data, velocity and shear stress profiles were generated that showed possible areas of improvement. It was concluded that the outlet port design could be improved by changing its angle and the continuity of its expansion. The inlet port could also be improved by smoothing the transition area between the inlet tube and the pump body to allow for gradual acceleration of the entering fluid.

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.

A pivot bearing-supported centrifugal blood pump has been developed. It is a compact, cost effective, and anti-thrombogenic pump with anatomical compatibility. A preliminary evaluation of five paracorporeal left ventricular assist studies were performed on pre-conditioned bovine (70-100 kg), without cardiopulmonary bypass and aortic cross-clamping. The inflow cannula was inserted into the left ventricle (LV) through the apex and the outflow cannula affixed with a Dacron vascular graft was anastomosed to the descending aorta. All pumps demonstrated trouble free performance over a two-week screening period. Among these five studies, three implantations were subjected for one month system validation studies. All the devices were trouble free for longer than 1 month. (35, 34, and 31 days). After achieving one month studies, all experiments were terminated. There was no evidence of device induced thrombus formation inside the pump. The plasma free hemoglobin levels were within normal ranges throughout all experiments. As a consequence of these studies, a mass production model C1E3 of this pump was fabricated as a short-term assist pump. This pump has a Normalized Index of Hemolysis of 0.0007 mg/100L and the estimated wear life of the impeller bearings is longer than 8 years. The C1E3 will meet the clinical requirements as a cardiopulmonary bypass pump. For the next step, a miniaturized pivot bearing centrifugal blood pump PI-601 has been developed for use as a permanently implantable device after design optimization. The evolution from C1E3 to the PI-601 converts this pivot bearing centrifugal pump as a totally implantable centrifugal pump. A pivot bearing centrifugal pump will become an ideal assist pump for the patients with failing heart.