In Vitro Investigation of Thrombogenesis in Rotary Blood Pumps

Abstract: Thrombus formation at sealing and stagnation areas remains a major problem in the development of rotary blood pumps. Until now, the complex phenomena could only be studied in vivo. In this study, an in vitro mock circulation previously used for hemolysis studies was adapted for thrombosis evaluation. Blood was collected in the slaughterhouse with strict avoidance of air contact and was heparinized (1.5 U heparin/ml blood; activated coagulation time [ACT]: initially, 140–180 s; after collection, 400–600 s). During the test, the ACT decreased gradually. The tests were stopped after 90 to 180 min at an ACT of 1.5 times the initial value. Thrombus formation was observed at the same locations as observed in left-heart assist devices (sealing area, connecting bolts, and stagnant water areas at connectors). The thrombi were similar in shape, color, and histology to those found after 2 to 4 days in vivo. This test provides a valuable tool for evaluating thrombus formation in prototypes and screening tests of different rotary pump designs.     

In Vitro Hematological Testing of Rotary Blood Pumps: Remarks on Standardization and Data Interpretation

Abstract: Pump test procedures using blood will have to meet several standards not only to obtain reliable results in vitro but also to allow comparison of results of different investigators. This article reviews some of the issues that should be considered in pump testing, especially referring to the discussions held at the International Workshops on Rotary Blood Pumps in 1988 and 1991. The test loop itself should meet some requirements such as constant physiological temperature, standardized circulating volume, control of pressure and flow, and exact definition of the blood-contacting surface. Specifications have to be made concerning the test fluid blood, including sampling technique, anticoagulation, blood gases, pH, and glucose level. Only fresh blood should be used. Heparin is recommended for anticoagulation because it will be used also in vivo. Different procedures for cleaning and rinsing of plastic materials for reuse are mentioned. Bacterial overgrowth, which can lead to extreme oxygen consumption and acidosis, may be avoided through addition of antibiotics (e.g., gentamicin). To be able to compare data of the different working groups, a new modified index of hemolysis (MIH) has been defined.     

Analysis of Pressure Head‐Flow Loops of Pulsatile Rotodynamic Blood Pumps

The clinical importance of pulsatility is a recurring topic of debate in mechanical circulatory support. Lack of pulsatility has been identified as a possible factor responsible for adverse events and has also demonstrated a role in myocardial perfusion and cardiac recovery. A commonly used method for restoring pulsatility with rotodynamic blood pumps (RBPs) is to modulate the speed profile, synchronized to the cardiac cycle. This introduces additional parameters that influence the (un)loading of the heart, including the timing (phase shift) between the native cardiac cycle and the pump pulses, and the amplitude of speed modulation. In this study, the impact of these parameters upon the heart‐RBP interaction was examined in terms of the pressure head‐flow (HQ) diagram. The measurements were conducted using a rotodynamic Deltastream DP2 pump in a validated hybrid mock circulation with baroreflex function. The pump was operated with a sinusoidal speed profile, synchronized to the native cardiac cycle. The simulated ventriculo‐aortic cannulation showed that the level of (un)loading and the shape of the HQ loops strongly depend on the phase shift. The HQ loops displayed characteristic shapes depending on the phase shift. Increased contribution of native contraction (increased ventricular stroke work [W_S]) resulted in a broadening of the loops. It was found that the previously described linear relationship between W_S and the area of the HQ loop for constant pump speeds becomes a family of linear relationships, whose slope depends on the phase shift.     

Biomaterials for Rotary Blood Pumps

Abstract: Rotary blood pumps are used for cardiac assist and cardiopulmonary support since mechanical blood damage is less than with conventional roller pumps. The high shear rate in the rotary pump and the reduced anti-coagulation of the patient during prolonged pumping enforces high demands on the biocompatibility of the materials in the pump in order to prevent thrombus formation. Materials with a very hydrophobic character appear to adsorb much thrombin and induce a conformational change of fibrinogen, resulting in a surface with a high affinity for platelet interaction. Furthermore, heigh shear forces of 120 dyne-s-cm² in rotary pumps induce platelet release and platelet aggregation. Thus, hydrophobic materials and high shear rates should be prevented to avoid thrombus formation in rotary blood pumps.     

Purge System for Rotary Blood Pumps

Abstract: Purge liquid has been supplied successfully to lubricate the bearings and wash the seals of rotary blood pumps to minimize hemolysis and thrombosis, extending their operating endurance. Although encouraging results have been obtained and development is proceeding for pumps with blood lubricated bearings, their validation and clinical use will occur some time in the future. For rotary blood pumps with purged bearings, a miniature purge liquid pump weighing 80 g has been successfully developed to meet the design point of 1 ml/h at 1,000 mm Hg (required by an existing rotary blood pump) with a motor power of 4 mW. The novel device maintains the flow rate for a sufficient time to service or replace the pump without flow interruption. A preliminary design has been made for a wearable purge delivery unit comprising a purge liquid pump, an electronic control, a purge liquid reservoir, and a battery.     

Comparative Hemolysis Tests of Rotary Blood Pumps

Abstract: At present, hemolysis is one of the most important characteristics used to evaluate rotary blood pumps. However, the conditions of testing procedures in various research centers differ considerably. We proposed to conduct the experiments under conditions similar to those from clinical applications of arterial pumps in ex-tracorporeal perfusion. Proceeding from these considerations, the following parameters of Hemolysis (H) testing were adopted: output, 6 L/min; difference of pressure, 300 mm Hg; initial hematocrit, 30 mg%; and initial hemolysis (PHbo) <5 mg%. The channel pump IBP80 designed on the basis of the BP80 was tested using fresh human blood. The experimental results indicate that the H level due to the use of the IBP80 is 2–3 times less than H for the BP80. H dependence on the difference of pressure in the range between 200 and 300 mm Hg was noted for the BP80, which can be accounted for by the transition of the laminar conditions of flow to turbulence. According to the results of the hydrodynamic efficiency evaluation, the IBP80 is twice as efficient as the BP80.     

Power Consumption of Rotary Blood Pumps: Pulsatile Versus Constant‐Speed Mode

We investigated the power consumption of a HeartMate III rotary blood pump based on in vitro experiments performed in a cardiovascular simulator. To create artificial‐pulse mode, we modulated the pump speed by decreasing the mean speed by 2000 rpm for 200 ms and then increasing speed by 4000 rpm (mean speeds plus 2000 rpm) for another 200 ms, creating a square waveform shape. The HeartMate III was connected to a cardiovascular simulator consisting of a hydraulic pump system to simulate left ventricle pumping action, arterial and venous compliance chambers, and an adjustable valve for peripheral resistance to facilitate the desired aortic pressure. The simulator operated based on Suga's elastance model to mimic the Starling response of the heart, thereby reproducing physiological blood flow and pressure conditions. We measured the instantaneous total electrical current and voltage of the pump to evaluate its power consumption. The aim was to answer these fundamental questions: (i) How does pump speed modulation affect pump power consumption? (ii) How does the power consumption vary in relation to external pulsatile flow? The results indicate that speed modulation and external pulsatile flow both moderately increase the power consumption. Increasing the pump speed reduces the impact of external pulsatile flow.     

Flow Visualization as a Complementary Tool to Hemolysis Testing in the Development of Centrifugal Blood Pumps

Abstract With a 250% scaled-up pump model, high speed video camera, and argon ion laser light sheet, flow patterns related to hemolysis were visualized and analyzed with 4 frame particle tracking software. Different flow patterns and shear distributions were clarified by flow visualization for pumps modified to have different hemolysis levels. A combination of in vitro hemolysis tests, flow visualization, and CFD analysis suggested a close relationship between hemolysis and high shear caused by small impeller/casing gaps. Because arbitrary cross sections can be illuminated by laser light sheet, flow visualization is a useful tool in finding locations related to hemolysis in the design process of rotary blood pumps.     

Estimation of the Native Cardiac Output from a Rotary Blood Pump Flow: In Vitro Study

Abstract The rotary blood pump will be an implantable left ventricular assist device (LVAD) in the near future. However, the best control method and the interrelationship between the rotary blood pump and native heart functions are unclear. An estimation was made of the native heart cardiac output from the change of an LVAD's outflow waveform. The mock circulation loop was composed of an aortic compliance chamber, left arterial chamber, total artificial heart as a native heart, and a rotary blood pump that was placed as an LVAD with left ventricular drainage. The fast Fourier transform (FFT) technique was utilized to analyze the LVAD's outflow waveform and calculate the pulse power index (PPI) to examine a relation between the PPI and total artificial heart (TAH) output. The PPI increased with the increase of the TAH output; there was a positive correlation, and there was an inverse correlation between the PPI and the assist ratio. From this viewpoint, an estimation of the pulsatility change of the LVAD's outflow wave may indicate the native cardiac output.     

Sealing Performance of a Magnetic Fluid Seal for Rotary Blood Pumps

A magnetic fluid (MF) for a rotary blood pump seal enables mechanical contact-free rotation of the shaft and, hence, has excellent durability. The performance of a MF seal, however, has been reported to decrease in liquids. We have developed a MF seal that has a "shield" mechanism and a new MF with a higher magnetization of 47.9 kA/m. The sealing performance of the MF seal installed in a rotary blood pump was studied. Under the condition of continuous flow, the MF seal remained in perfect condition against a pressure of 298 mm Hg (pump flow rate: 3.96 L/min). The seal was also perfect against a pressure of 170 mm Hg in a continuous flow of 3.9 L/min for 275 days. We have developed a MF seal that works in liquid against clinically used pressures. The MF seal is promising as a shaft seal for rotary blood pumps.     

The Safety System for the Rotary Blood Pump, Combination of the Valve and LVAD Pulsatile Mode: In Vitro Test

The significant amount of regurgitation produced by a stopped rotary blood pump is one of the major considerations for its use as an implantable left ventricular assist device (LVAD), especially if the pump accidentally stops. The installation of a valve is an option for the solution of this potential problem. However, this option may lead to thrombogenic problems, particularly if the valve motion is restricted. This in vitro study analyzes the valve performance and assesses the credibility of a rotary blood pump valve. A pulsatile pump was used as the natural heart and a centrifugal pump as the LVAD. The valve was positioned into the LVAD outflow. In the low speed range (<1,000 rpm in this test condition), normal valve motion was maintained. Also, the valve model provided a higher mean bypass flow than the model without a valve due to reduced regurgitation. However, the valve motion was drastically restricted when in the high speed range (>1,600 rpm in this condition). The pulsatile mode was applied to the LVAD by periodically changing the impeller speed (40 bpm); subsequently, a constant valve motion could be provided. A possibility exists that this pulsatile mode application could eliminate thrombosis formation around the valve. A conclusion was made that the combination of a valve and an LVAD in a pulsatile mode is considered to be a unique safety system for a rotary blood pump.     

Development of Design Methods of a Centrifugal Blood Pump with In Vitro Tests, Flow Visualization, and Computational Fluid Dynamics: Results inHemolysis Tests

Abstract There are few established engineering guidelines aimed at reducing hemolysis for the design of centrifugal blood pumps. In this study, a fluid dynamic approach was applied to investigate hemolysis in centrifugal pumps. Three different strategies were integrated to examine the relationship between hemolysis and flow patterns. Hemolytic performances were evaluated in in vitro tests and compared with the flow patterns analyzed by flow visualization and computational fluid dynamic (CFD). Then our group tried to establish engineering guidelines to reduce hemolysis in the development of centrifugal blood pumps. The commercially available Nikkiso centrifugal blood pump (HPM-15) was used as a standard, and the dimensions of 2 types of gaps between the impeller and the casing, the axial and the radial gap, were varied. Four impellers with different vane outlet angles were also prepared and tested. Representative results of the hemolysis tests were as follows: The axial gaps of 0.5, 1.0, and 1.5 mm resulted in normalized index of hemolysis (NIH) values of 0.0028, 0.0013 and 0.0008 g/100 L, respectively. The radial gaps of 0.5 and 1.5 mm resulted in NIH values of 0.0012 and 0.0008 g/100 L, respectively. The backward type vane and the standard one resulted in NIH values of 0.0013 and 0.0002 g/100 L, respectively. These results revealed that small gaps led to more hemolysis and that the backward type vane caused more hemolysis. Therefore, the design parameters of centrifugal blood pumps could affect their hemolytic performances. In flow visualization tests, vortices around the impeller outer tip and tongue region were observed, and their patterns varied with the dimensions of the gaps. CFD analysis also predicted high shear stress consistent with the results of the hemolysis tests. Further investigation of the regional flow patterns is needed to discuss the cause of the hemolysis in centrifugal blood pumps.     

Flow Visualization Study on Centrifugal Blood Pump Using a High Speed Video Camera

Abstract: Flow visualization is widely applied to evaluate rotary blood pumps; however, it is very difficult to visualize flow near the vanes of centrifugal blood pumps because the rotational speed of the impeller is usually several thousand rpm. In this study, a tracer method with a high speed video camera that can take more than 2,000 frames/s was utilized for flow visualization together with computer-assisted image measurement. This method visualized the complex secondary flow pattern near the vanes of the impeller, such as the vortex and recircula-tion. It also visualized the enhanced washout effect by the secondary washout vanes on the backside of the impeller. The proposed method was effective to analyze the flow pattern in the centrifugal blood pump by providing useful information for better design of the pump hemolysis and thrombus formation.     

A Ferrofluidic Seal Specially Designed for Rotary Blood Pumps

Abstract One of the key technologies required for rotary blood pumps is sealing of the motor shaft. A ferrofluidic seal was developed for an axial flow pump. The seal body was composed of a plastic magnet and two pole pieces. This seal was formed by injecting ferrofluid into the gap between the pole pieces and the motor shaft. To contain the ferrofluid in the seal and to minimize the possibility of ferrofluid making contact with blood, a shield with a small cavity was provided on the pole piece. Sealing pressure of the seal was measured. The sealing pressure was maintained at more than 23.3 kPa (175 mm Hg) for a motor speed up to 11,000 rpm. The specially designed ferrofluidic seal for sealing out liquids is useful for axial flow blood pumps.     

Development of the Marseilles Pulsatile Rotary Blood Pump for Permanent Implantable Left Ventricular Assistance

Abstract: We have developed a low–speed, double–lobed hypocycloidal pump that furnishes a pulsatile flow without valves. The pump is coupled to a specially designed electric motor. The motor/pump unit is totally implantable and has been extensively tested in vitro and in vivo in animals. Because this pump is volumetric, it is necessary to control speed precisely to avoid overpumping. Our control system, which is based on analysis of the motor current wave form, can detect and prevent negative pressures before they occur. The physical properties and hemocompatibility of several construction materials have been studied to determine their suitability for clinical use. These materials include a graphite substrate, titanium nitrate surface coating, boric carbon, and amorphous diamond. The pumps currently being tested are made of titanium, but clinical versions will be made of composite materials selected from this preliminary study. In vivo testing of this pump confirmed its good hemodynamic performance, low hemolysis rate, and biocompatibility (i. e., low heat, noise, and vibration levels). Animal experiments were terminated after 15 days because of mechanical failure related to the accumulation of blood components on moving parts. A new pump in which the mechanism is completely sealed from the blood flow has been designed and will soon be tested. If this sealed design is effective, the pump should be ready for use as a permanent implantable ventricular assistance device.     

Differences Between Blood and a Newtonian Fluid on the Performance of a Hydrodynamic Bearing for Rotary Blood Pumps

Assuming that blood has a constant viscosity is a common practice when designing rotary blood pumps (RBPs), where shear stresses are generally higher than in the human body. This eases the design and allows numerical simulations and bench top experiments to be performed with Newtonian fluids. However, specific flow conditions may cause a change in cell distribution leading to an apparent lower blood viscosity. It has been observed that decreasing the vessel diameters and increasing flow velocities contribute to this effect. Because a hydrodynamic bearing operates under flow conditions following this pattern, it is important to verify whether this effect also takes place when this type of bearing is applied to a RBP. Because the operation of a hydrodynamic bearing depends directly on the fluid viscosity, a local change in cell distribution in the bearing gap can be reflected in changes in the bearing performance. In this work, a spiral groove hydrodynamic bearing was tested with porcine blood in a specially built test rig. The generated suspension force, cross flow, and bearing torque were recorded and compared with the reference response when using a solution of water and glycerol. Experiments with porcine blood yielded lower suspension forces, lower flows, and lower bearing torques than when using the glycerol solution. An explanation could be a lower apparent viscosity due to inhomogeneity of blood cell concentrations. Therefore, it is crucial to consider the effective blood viscosity when designing hydrodynamic bearings for RBPs and performing experiments.     

In Vitro Evaluation of an Immediate Response Starling‐Like Controller for Dual Rotary Blood Pumps

Rotary ventricular assist devices (VADs) are used to provide mechanical circulatory support. However, their lack of preload sensitivity in constant speed control mode (CSC) may result in ventricular suction or venous congestion. This is particularly true of biventricular support, where the native flow‐balancing Starling response of both ventricles is diminished. It is possible to model the Starling response of the ventricles using cardiac output and venous return curves. With this model, we can create a Starling‐like physiological controller (SLC) for VADs which can automatically balance cardiac output in the presence of perturbations to the circulation. The comparison between CSC and SLC of dual HeartWare HVADs using a mock circulation loop to simulate biventricular heart failure has been reported. Four changes in cardiovascular state were simulated to test the controller, including a 700 reduction in circulating fluid volume, a total loss of left and right ventricular contractility, reduction in systemic vascular resistance ( ) from 1300 to 600 , and an elevation in pulmonary vascular resistance ( ) from 100 to 300 . SLC maintained the left and right ventricular volumes between 69–214 and 29–182 respectively, for all tests, preventing ventricular suction (ventricular volume = 0 ) and venous congestion (atrial pressures > 20 ). Cardiac output was maintained at sufficient levels by the SLC, with systemic and pulmonary flow rates maintained above 3.14 for all tests. With the CSC, left ventricular suction occurred during reductions in SVR, elevations in PVR, and reduction in circulating fluid simulations. These results demonstrate a need for a physiological control system and provide adequate in vitro validation of the immediate response of a SLC for biventricular support.     

Transcutaneous Energy Transfer with Voltage Regulation for Rotary Blood Pumps

Abstract Rotary blood pumps often require a constant operating voltage. To meet this requirement and to eliminate the need for percutaneous leads, a voltage-regulated transcutaneous energy transfer (TET) system has been developed. Voltage regulation is achieved by using a transcutaneous infrared feedback control loop operating on a 890 nanometer (nm) wavelength. In vitro testing of the system developed has shown that output voltage can be maintained to within 0.2 V of nominal (14.5 V) for delivered powers up to 50 watts (W) and coil separations of between 3 and 10 mm. Power transfer efficiencies were determined to be from 68% to 72% over the tested range of coil separations and output currents from 1.5 to 3.6 amperes (A). This system has demonstrated acceptable performance in regulating output voltage while transferring power inductively without using percutaneous connections. By integrating this type of TET system with an implanted rotary blood pump, the quality of life for the device recipient could be improved.     

Coronary Hemodynamics and Myocardial Oxygen Consumption During Support With Rotary Blood Pumps

Mechanical support offered by rotary pumps is increasingly used to assist the failing heart, although several questions concerning physiology remain. In this study, we sought to evaluate the effect of left-ventricular assist device (VAD) therapy on coronary hemodynamics, myocardial oxygen consumption, and pulmonary blood flow in sheep. We performed an acute experiment in 10 sheep to obtain invasively measured coronary perfusion data, as well as pressure and flow conditions under cardiovascular assistance. A DeBakey VAD (MicroMed Cardiovascular, Inc., Houston, TX, USA) was implanted, and systemic and coronary hemodynamic measurements were performed at defined baseline conditions and at five levels of assistance. Data were measured when the pump was clamped, as well as under minimum, maximum, and moderate levels of assistance, and in a pump-off condition where backflow occurs. Coronary flow at the different levels of support showed no significant impact of pump activity. The change from baseline ranged from −10.8% to +4.6% (not significant [n.s.]). In the pulmonary artery, we observed a consistent increase in flow up to +4.5% (n.s.) and a decrease in the pulmonary artery pressure down to −14.4% ( P  = 0.004). Myocardial oxygen consumption fell with increasing pump support down to −34.6% ( P  = 0.008). Left-ventricular pressure fell about 52.2% ( P  = 0.016) as support was increased. These results show that blood flow in the coronary arteries is not affected by flow changes imposed by rotary blood pumps. An undiminished coronary perfusion at falling oxygen consumption might contribute to cardiac recovery.