Effect of surface roughness on hemolysis in a centrifugal blood pump.

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 cardiopulmonary 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.

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.

Evaluation of floating impeller phenomena in a gyro centrifugal pump.

The Gyro centrifugal pump, developed as a totally implantable artificial heart, was designed with a free impeller in which the rotational shaft (male bearing) of the impeller was completely separated from the female bearing. For this type of pump, it is very important to keep the proper magnet balance (impeller-magnet and actuator-magnet balance) to prevent thrombus formation or bearing wear. When the magnet balance is not proper, the impeller is jerked down into the bottom bearing. On the other hand, if magnet balance is proper, the impeller is lifted off the bottom of the pump housing within a certain range of pumping conditions. In this study, this floating phenomenon was investigated in detail. The floating phenomenon was proven by observation of the impeller behavior by means of a transparent acrylic pump. The impeller floating phenomenon was mapped on a pump performance curve. The impeller floating phenomenon is affected by the magnet-magnet coupling distance and the rotational speed of the impeller. To keep the proper magnet balance and to maintain the impeller floating phenomenon at the driving conditions of right and left pumps, the magnet-magnet coupling distance was altered by a spacer that was installed between the pump and actuator. It became clear that the same pump could handle different conditions (right and left ventricular assist) by changing the thickness of the spacer. When magnet balance is proper, the floating impeller phenomenon occurs automatically in response to the impeller revolution. This is called "the dynamic revolutions per minute suspension."

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.

Blood trauma induced by clinically accepted oxygenators.

Hemolysis remains one of the most serious problems during cardiopulmonary bypass (CPB), extracorporeal membrane oxygenation (ECMO), and percutaneous cardiopulmonary support (PCPS). However, the hemolytic characteristics associated with oxygenators are not well defined. A specialized hemolysis test protocol for oxygenators was developed. A comparative study was performed following this protocol to determine the hemolytic characteristics of the clinically available oxygenators during CPB; pressure drop measurements in the blood chamber were also performed. Four oxygenators (Medtronic Affinity, Cobe Optima, Terumo Capiox SX25, and Bard Quantum) were evaluated. Fresh blood from healthy Dexter calves anticoagulated with citrate phosphate dextrose adenine solution was used. The blood flow was fixed at 5 L/min, similar to that used in CPB. The Normalized Index of Hemolysis for Oxygenators (NIHO) has been modified according to the American Society of Testing and Materials (ASTM) standards. The NIH value, which was obtained from the circuit without an oxygenator, was subtracted from the primary NIH value, obtained from the circuit with an oxygenator to eliminate the effects of a centrifugal pump or other artifacts. The NIHO value was the lowest in the Affinity (0.0116 +/- 0.0017) and increased from Affinity < Optima (0.0270 +/- 0.0038) < Capiox (0.0335 +/- 0.0028) < Quantum (0.0416 +/- 0.0015 g/100 L). The Optima and Capiox did not demonstrate a significant difference. In addition, this NIHO value has a close relationship to the pressure drop. In conclusion, this new evaluation method is suitable to compare the biocompatibility performance of different types of clinically available oxygenators for CPB usage.

Development of an antithrombogenic and antitraumatic blood pump: the Gyro C1E3.

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.

Recent advances in the gyro centrifugal ventricular assist device.

The gyro pump was developed as an intermediate-term assist pump (C1E3) as well as a long-term centrifugal ventricular assist device (VAD). The antithrombogenic design concept of this pump was confirmed throughout three 1 month ex vivo studies. The normalized index of hemolysis (NIH) of this gyro C1E3 model was lower than that of the BP-80. In the next step, a miniaturized centrifugal blood pump (The Gyro permanently implantable model PI-601) has been developed for use as a permanently implantable device after design optimization. A special motor design of the magnet circuit was utilized in this system in collaboration with the University of Vienna. The priming volume of this pump is 20 ml. The overall size of the pump actuator package is 53 mm in height, 65 mm in diameter, 145 ml of displacement volume, and 305 g in weight. This pump can provide 5 L/min against 120 mm Hg total pressure head at 2,000 rpm. The NIH value of this pump was comparable to that of the BP-80. The gyro PI-601 model is suitable for a VAD. The expected life from the endurance study is approximately 8 years. The evolution from C1E3 to the PI-601 converts this pump to a totally implantable centrifugal pump. Recent technologic advances in continuous flow devices are likely to realize a miniaturized and economical totally implantable VAD.

Development of an implantable small right ventricular assist device.

Currently, at least two permanent implantable left ventricular assist devices (LVADs) are used clinically. Unfortunately, there is no small implantable right ventricular assist device (RVAD) available, even though at least 25-30% of this patient population has right ventricular failure. If a small implantable RVAD were available, biventricular assist could support patients with right ventricular failure. A small atraumatic and antithrombogenic RVAD is being developed to meet this clinical need. This small centrifugal blood pump, the Gyro PI pump, is 6.5 cm in diameter and 4.6 cm in height and has three unique characteristics to prevent thrombus formation: (1) the double pivot bearing and magnetic coupling system enable this pump to be completely sealless; (2) the secondary vanes at the bottom of the impeller accelerate the blood flow and prevent blood stagnation; and (3) the eccentric inlet port enables the top female bearing to be embedded into the top housing and decrease blood cell trauma. The inflow conduit consists of a wire reinforced tube and a hat-shaped tip that is biolized with gelatin to create a thrombus resistant material. This conduit is directly implanted into the right ventricle, and the outflow conduit is anastomosed to the PA. The pump can be implanted inside the abdominal wall or in the thoracic cavity. Biocompatibility of this pump was proved in two calves by thrombus free implantation as an LVAD for 284 days and 200 days. Two RVAD implantations were conducted, aiming for 1-month system feasibility studies. During the month, the RVADs operated satisfactorily without any thromboembolic incident. No blood clots or abnormal findings were seen inside the pump, nor were there abnormal findings in the explanted lungs except for small areas of atelectasis. The pump flow was 3.02 +/- 0.38 L/min in calf 1 and 3.75 +/- 1.18 L/min in calf 2. The power requirement was 7.28 +/- 0.43W for calf 1 and 14.52 +/- 3.93W for calf 2. The PaO2 was 72.0 +/- 3.60 mm Hg (calf 1) and 72.0 +/- 7.63 mm Hg (calf 2); PaCO2 was 38.3 +/- 2.17 mm Hg (calf 1) and 34.1 +/- 1.95 mm Hg (calf 2); and SaO2 was 94.1 +/- 1.37% (calf1) and 95.0 +/- 1.95% (calf 2). Gas exchange via the lungs was maintained. These studies indicate that the Gyro PI pump is suitable as a single implantable RVAD, and is a feasible RVAD as a part of a BiVAD system in terms of pump performance and thrombus resistance.

Operating point control system for a continuous flow artificial heart: in vitro study.

We proposed and developed a practical and effective servo control system for rotary blood pumps. A rotary blood pump for assisting the failing natural heart should be operated only in physiologically acceptable conditions. The operation of a rotary blood pump is based on the rotational speed of the impeller and pressure head. If the pump flow and the pressure head are set within an acceptable range, the driving condition is deemed normal condition, and this control system maintains the preset operating point by applying proportional and detective control (PD control). If the pump flow or pressure head is outside the acceptable range, the driving condition is determined to be abnormal condition, and this system operates the pump in a recovery fashion. If the driving condition is kept under abnormal conditions of sudden decrease of the flow, the condition is termed a suction condition. The controller releases the pump from the suction condition and later returns it to the normal condition. In this study, we evaluated these servo control modes of the centrifugal pump and confirmed whether the performance of this proposed operating point control system was practical.

Long-term in vivo left ventricular assist device study with a titanium centrifugal pump.

A totally implantable centrifugal artificial heart has been developed. The plastic prototype, Gyro PI 601, passed 2 day hemodynamic tests as a functional total artificial heart, 2 week screening tests for antithrombogenicity, and 1 month system feasibility. Based on these results, a metallic prototype, Gyro PI 702, was subjected to in vivo left ventricular assist device (LVAD) studies. The pump system employed the Gyro PI 702, which has the same inner dimensions and the same characteristics as the Gyro PI 601, including an eccentric inlet port, a double pivot bearing system, and a magnet coupling system. The PI 702 is driven with the Vienna DC brushless motor actuator. For the in vivo LVAD study, the pump actuator package was implanted in the preperitoneal space in two calves, from the left ventricular apex to the descending aorta. Case 1 achieved greater than 9 month survival without any complications, at an average flow rate of 6.6 L/min with 10.2 W input power. Case 2 was killed early due to the excessive growth of the calf, which caused functional obstruction of the inlet port. There was no blood clot inside the pump. During these periods, neither case exhibited any physiologic abnormalities. The PI 702 pump gives excellent results as a long-term implantable LVAD.

A pivot bearing-supported centrifugal pump for a long-term assist heart.

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 P1-601 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.

Control system for an implantable rotary blood pump.

Rotary blood pumps can be used for long-term left ventricular assist devices. These pumps have several advantages over the conventional pulsatile pumps including smaller size, higher efficiency, and simple design and construction. However, one of the difficulties associated with the rotary blood pump is the proper control method to maintain an optimum flow rate in different physiological conditions. The rotary blood pump can be controlled by two methods. The first is to utilize the measured pump flow rate from its servo signal. The second is to detect and avoid abnormal pumping conditions such as; back flow and sudden increase in the pressure head. This abnormal situation typically occurs from excessive suction of blood when there is a functional or mechanical occlusion in the inflow cannula. The ultrasound flow meter is durable and reliable but it is difficult to continually monitor the blood flow rate of an implantable pump. Therefore, another method is needed instead of the continuous flow monitoring. One chronic calf having an LVAD was subjected for the development of this control system. This calf survived more than 6 months. Voltage, current, motor speed, heart rate and the pump flow rate were recorded and stored at 30-min intervals in a computer. Utilizing these parameters, attempts were made (1) to achieve indirect flow assessments and (2) to reveal abnormal operating parameters of the centrifugal pump (1). Indirect flow measurement, the predicted pump flow rate was calculated from these pump derived parameters (required power, motor speed and heart rate). The value of the coefficient of determination (R) between the measured and estimated pump flow rate was 0.796. (2) Abnormal operating indicator, there was an association between the required current and pump flow waves. The current was differentiated, and then calculated to the power of the differentiated current. The normal range of this value was 0.02+/-0.54. In abnormal conditions, this abnormal operating indicator increased 500 times. The predicted flow estimation method and abnormal operating indicator were available from intrinsic operating parameters of the pump and need no sensors. These two methods were simple, yet they are possibly effective and reliable servo control methods for a rotary blood pump.

Evaluation of floating impeller phenomena in a Gyro centrifugal pump.

The Gyro centrifugal pump developed as a totally implantable artificial heart was designed with a free impeller, in which the rotational shaft (male bearing) of the impeller was completely separated from the female bearing. For this type of pump, it is very important to keep the proper magnet balance (impeller-magnet and actuator-magnet) in order to prevent thrombus formation and/or bearing wear. When the magnet balance is not proper, the impeller is jerked down into the bottom bearing. On the other hand, if magnet balance is proper, the impeller lifted off the bottom of the pump housing within a certain range of pumping conditions. In this study, this floating phenomenon was investigated in detail. The floating phenomenon was proved by observation of the impeller behavior using a transparent acrylic pump. The impeller floating phenomenon was mapped on a pump performance curve. The impeller floating phenomenon is affected by the magnet-magnet coupling distance and rotational speed of the impeller. In order to keep the proper magnet balance and to maintain the impeller floating phenomenon at the driving condition of right and left pump, the magnet-magnet coupling distance was altered by a spacer which was installed between the pump and actuator. It became clear that the same pump could handle different conditions (right and left ventricular assist), by just changing the thickness of the spacer. When magnet balance is proper, the floating impeller phenomenon occurs automatically in response to the impeller rev. It is called "the dynamic RPM suspension".

Comparative in vitro encrustation studies of biomaterials in human urine.

A new dynamic in vitro human urine model was developed to compare biomaterial encrustation. The model incorporates a capacity to study seven biomaterials, a daily urine inflow of 500 ml, a reservoir capacity of 700 ml, and a turnover rate of four days. Encrustation studies performed for 2 weeks in sterile and infected (Proteus Vulgaris) urine on segmented polyether polyurethane, polyester polyurethane, silicone (Mitsui), silicone (Dow Corning), biothane, biolor 1 and biolor 11 demonstrated that biolor 11 (silicone-carbon composite) caused the least encrustation. Encrustation analysis showed brushite in the sterile model and struvite and ammonium acid urate in the infected mode I. Biolor II should have beneficial applications in catheters, stents and prosthetics which come in contact with urine.

Eccentric inlet port of the pivot bearing supported Gyro centrifugal pump.

An eccentric inlet port is a unique feature of the pivot bearing supported Gyro Compact-1 Eccentric Inlet Port Model 3 (C1E3) centrifugal pump, a completely sealless 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.

Vibration assessment for thrombus formation in the centrifugal pump.

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.

Hemolytic effect of surface roughness of an impeller in a centrifugal blood pump.

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 L/min, 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.

In vitro thrombogenesis study in the Gyro C1E3 for vibration assessment.

To clarify the correlation between vibration and thrombus formation in a centrifugal blood pump, a preliminary simulated thrombus study was conducted for possible detection of thrombus formation inside a pump. Additional in vitro thrombogenesis studies were performed to confirm the results of the preliminary study. The primary data acquisition equipment included an accelerometer (Isotron PE accelerometer, Endevco, San Juan Capistrano, CA, U.S.A.), digitizing oscilloscope (TDS 420, Tektronic, Inc., MA, U.S.A.), and pivot bearing centrifugal pumps. The accelerometer was mounted to the top of the pump casing to sense radial and axial accelerations. For the preliminary study, a piece of Silastic was adhered to each of the 3 common areas of thrombus formation inside the pump. The results provided baseline information to speculate on the possibility of detecting thrombus formation by vibration signal changes. For the next studies, fresh bovine blood was harvested under sterile conditions and with strict avoidance of air contact, adding 1.0 U/ml of heparin. The sterilized test circuit consisted of 3/8 inch tubing (Tygon) and a soft reservoir. During the operating time, the activated clotting time (ACT) was maintained between 150 to 300 s using protamin. A restrictor on the outflow tube maintained the flow rates at about 4.5 L/min. The pumps ran continuously for 6 h. Possible blood clot formation inside the pump was monitored by observing the vibration signal from the device for 6 h. These studies revealed that it was possible to distinguish between an impeller that did not form thrombus and ones that formed fibrogenous thrombus using vibration signal assessment. Vibration assessment is worthwhile as a thrombus monitoring tool for a centrifugal blood pump.

Comparison of Delphin and BioMedicus pumps.

There is an increasing use of centrifugal pump systems for cardiopulmonary bypass (CPB) and circulatory assistance. The BioMedicus and Delphin centrifugal pump systems were tested in two side-by-side, identical in vitro flow loops for blood trauma and flow probe accuracy. Blood parameters tested were hemoglobin, hematocrit, lactate dehydrogenase, free plasma hemoglobin, and platelet counts. The Delphin pump demonstrated significant increases in plasma hemoglobin levels at the three flow rates tested: 2 L/min (p less than 0.05), 4 L/min (p less than 0.005), and 6 L/min (p less than 0.05). After 4 hr of pumping, the drop in platelet counts was significantly greater in the BioMedicus loop as compared with the Delphin loop (p less than 0.05) at the 2 L/min and 4 L/min flow rates; however, platelet levels remained within normal ranges in both systems. At 6 L/min, no statistical difference in platelet counts was noted. The flow probe readings were found to deviate by as much as 58% of stopwatch timed flow rate comparisons at low flow rates, but improved to within 10% or better at 6 L/min.

Effect of surface roughness on hemolysis in a pivot bearing supported Gyro centrifugal pump (C1E3).

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.