Centrifugal Blood Pump Research Articles

Effect of the Center Post Establishment and Its Design Variations on the Performance of a Centrifugal Rotary Blood Pump

The main purpose is to compare the characteristics and performance of a centrifugal blood pump with and without center post. Furthermore, to propose a center post design guide for the development of centrifugal blood pumps: finding the appropriate height and diameter of the center post. A centrifugal blood pump with different center post configurations is investigated using Computational Fluid Dynamics (CFD) in an extensive parametric approach. Height and diameter of the center post are varied on 4 levels each. Pressure head and hydraulic efficiency curves, pressure and velocity contours and volumetric histograms of scalar shear stress (SSS) distribution are discussed in detail. The simulation results show uniform pressure distribution around the casing in the baseline design. Although obtaining the minimum Normalized Index of Hemolysis (NIH), average scalar shear stress (ASSS), and volumetric percentage ratios (SSS > 9, 50 and 150Pa), a stagnation and recirculation zone in the impeller eye above the casing bottom is detected in center post free (H = 0mm) pump. With the establishment and further increase of the center post height, the stagnation zone disappears gradually. The results also indicate that flow recirculation and stagnation around the circumference of the center post occurs when the center post has a small diameter. As the diameter increases, a reversed flow is formed between the impeller and the center post. The center post can greatly reduce the stagnation zone occurring in the center post free pump. The diameter of center post makes a difference to the flow field in the gap between the impeller and the center post.

Effects of gravity on flow rate estimations of a centrifugal blood pump using the eccentric position of a levitated impeller.

Implantable ventricular assist devices are a type of mechanical circulatory support for assisting the pumping of the heart. Accurate estimation of the flow rate through such devices is critical to ensure effective performance. A novel method for estimating the flow rate using the passively stabilized position of a magnetically levitated impeller was developed by our group. However, the performance of the method is affected by the gravity vector, which depends on the patient's posture. In this study, the effects of gravity on the flow estimation method are analyzed, and a compensation method is proposed. The magnetically levitated impeller is axially suspended and radially restricted by passive stability in a centrifugal blood pump developed by our group. The gravity effects were evaluated by analyzing the relationships between the radial position of the magnetically levitated impeller and the flow rate with respect to the gravity direction. Accurate estimation of the flow rate could not be achieved when the direction of gravity with respect to impeller was unknown. A mean absolute error of up to 4.89 L/min was obtained for flow rate measurement range of 0-5 L/min. However, analysis of the equilibrium of forces on the passively stabilized impeller indicated that the effects of gravity on the flow estimation could be compensated by performing additional measurements of the gravity direction with respect to impeller. The method for compensating the effects of gravity on the flow estimation should improve the performance of therapy with the implantable ventricular assist devices.

Numerical simulation and performance analysis of mixed flow blood pump

The high rotational speed of the axial flow blood pump and flow separation of the centrifugal blood pump are the main causes for blood damage in blood pump. The mixed flow blood pump can effectively alleviate the high rotational speed and the flow separation. Based on this, the purpose of this study is to explore the performance of the mixed blood pump with a closed impeller. A mixed flow blood pump with closed impeller was studied by numerical simulation in this paper. The flow field characteristics and the pressure distribution of this type of blood pump were analyzed. The hydraulic performance of the blood pump and the possible damages to red blood cells were also discussed. At last, pump performance was compared with the mixed flow blood pump with semi-open impeller. The results show that the mixed flow blood pump with close impeller studied in this paper can operate safely and efficiently with a good performance. The pump can reach the pressure head of 100 mmHg at 5 L/min mass flow rate. Flow in the blood pump is uniform and no obvious separation or vortex occurs. Pressure distribution in and on the impeller is uniform and reasonable, which can effectively avoid the thrombosis of blood. The average mean value of hemolysis index is 4.99 × 10 -4. The pump has a good biocompatibility. Compared with the mixed flow blood pump with semi-open impeller, the mixed flow blood pump with closed impeller has higher head and efficiency, a smaller mean value of hemolysis index prediction, a better hydraulic performance and the ability to avoid blood damage. The results of this study may provide a basis for the performance evaluation of the closed impeller mixed flow blood pump.

Impeller (straight blade) design variations and their influence on the performance of a centrifugal blood pump.

The miniaturization of blood pumps has become a trend due to the advantage of easier transplantation, especially for pediatric patients. In small-scale pumps, it is much easier and more cost-efficient to manufacture the impeller with straight blades compared to spiral-profile blades. Straight-blade impeller designs with different blade angles, blade numbers, and impeller flow passage positions are evaluated using the computational fluid dynamics method. Blade angles (θ = 0°, 20°, 30°, and 40°), blade numbers (N = 5, 6, 7, and 8), and three positions of impeller flow passage (referred to as top, middle, and bottom) are selected as the studied parametric values. The numerical results reveal that with increasing blade angle, the pressure head and the hydraulic efficiency increase, and the average scalar shear stress and the normalized index of hemolysis decrease. The minimum radial force and axial thrust are obtained when θ equals 20°. In addition, the minimum average scalar shear stress and normalized index of hemolysis values are obtained when N = 6, and the maximum values are obtained when N = 5. Regarding the impeller flow passage position, the axial thrust and the stagnation area forming in the impeller eye are reduced as the flow passage height declines. The consideration of a blade angle can greatly improve the performance of blood pumps, although the influence of the blade number is not very easily determined. The bottom position of the impeller flow passage is the best design.

Numerical Investigation of Centrifugal Blood Pump Cavitation Characteristics with Variable Speed

In this paper, the cavitation characteristics of centrifugal blood pumps under variable speeds were studied by using ANSYS-CFX and MATLAB software. The study proposed a multi-scale model of the “centrifugal blood pump—left heart blood circulation”, and analyzed the cavitation characteristics of the centrifugal blood pump. The results showed that the cavitation in the impeller first appeared near the hub at the inlet of the impeller. As the inlet pressure decreased, the cavitation gradually strengthened and the bubbles gradually developed in the outlet of the impeller. The cavitation intensity increased with the increase of impeller speed. The curve of the variable speeds of the centrifugal blood pump in the optimal auxiliary state was obtained, which could effectively improve the aortic pressure and flow. In variable speeds, due to the high aortic flow and pressure during the ejection period, the sharp increases in speeds led to cavitation. The results could provide a guidance for the optimal design of the centrifugal blood pump.

Tribology and Crystallinity in pivot bearings of Ventricular Assist Devices

Ventricular Assist Devices are blood pumps used in patients with Congestive Heart Failure who are waiting for a heart transplant. They aim to assist the ventricle to pump out blood in physiological circulation by increasing aortic pressure and decreasing intraventricular pressure. The IFSP Laboratory of Bioengineering and Biomaterials (BIOENG) has been developing an Implantable Centrifugal Blood Pump called CARoL for mechanical circulatory support. The objective of this dissertation is to evaluate the changes in the crystallinity of the polymeric Pivot Bearings supporting the impeller of this pump when subjected to friction generated by rotation of zirconia oxide ceramic shafts. The adopted methodology consisted of submitting new and used samples of: a) bearings set made of polyamide 6; and b) the set made of poly-ether-ether-ketone. Those new and used samples were characterized by X-ray diffraction tests and Infrared Spectroscopy. The diffractograms and spectra obtained were compared to evaluate the bearing crystallinity, for both polymers before and after friction. The tests carried out showed diffractograms and similar spectra for the new and used samples, thus, there are indications that the friction generated by the rotation of the shafts did not change the crystallinity of the polymeric bearings supporting the pump rotor.

Computational modeling of the Food and Drug Administration's benchmark centrifugal blood pump.

In order to simulate hemodynamics within centrifugal blood pumps and to predict pump hemolysis, CFD simulations must be thoroughly validated against experimental data. They must also account for and accurately model the specific working fluid in the pump, whether that is a blood-analog solution to match an experimental PIV study or animal blood in a hemolysis experiment. Therefore, the Food and Drug Administration (FDA) benchmark centrifugal blood pump and its database of experimental PIV and hemolysis data were used to thoroughly validate CFD simulations of the same blood pump. A Newtonian blood model was first used to compare to the PIV data with a blood analog fluid while hemolysis data were compared using a power-law hemolysis model fit to porcine blood data. A viscoelastic blood model was then incorporated into the CFD solver to investigate the importance of modeling blood's viscoelasticity in centrifugal pumps. The established computational framework, including a dynamic rotating mesh, animal blood-specific fluid properties and hemolysis modeling, and a k-ω SST turbulence model, was shown to more accurately predict pump pressure heads, velocity fields, and hemolysis compared to previously published CFD studies of the FDA centrifugal pump. The CFD simulations were able to match the FDA pressure and hemolysis data for multiple pump operating conditions, with the CFD results being within the standard deviations of the experimental results. While CFD radial velocity profiles between the impeller blades also compared well to the PIV velocity results, more work is still needed to address the large variability among both experimental and computational predictions of velocity in the diffuser outlet jet. Small differences were observed between the Newtonian and viscoelastic blood models in pressure head and hemolysis at the higher flow rate cases (FDA Conditions 4 and 5) but were more significant at lower flow rate and pump impeller speeds (FDA Condition 1). These results suggest that the importance of accounting for blood's viscoelasticity may be dependent on the specific blood pump operating conditions. This detailed computational framework with improved modeling techniques and an extensive validation procedure will be used in future CFD studies of centrifugal blood pumps to aid in device design and predictions of their biological responses.

In vitro evaluation of multi-objective physiological control of the centrifugal blood pump.

Left ventricular assist devices (LVADs) have been used as a bridge to transplantation or as destination therapy to treat patients with heart failure (HF). The inability of control strategy to respond automatically to changes in hemodynamic conditions can impact the patients' quality of life. The developed control system/algorithm consists of a control system that harmoniously adjusts pump speed without additional sensors, considering the patient's clinical condition and his physical activity. The control system consists of three layers: (a) Actuator speed control; (b) LVAD flow control (FwC); and (c) Fuzzy control system (FzC), with the input variables: heart rate (HR), mean arterial pressure (MAP), minimum pump flow, level of physical activity (data from patient), and clinical condition (data from physician, INTERMACS profile). FzC output is the set point for the second LVAD control schemer (FwC) which in turn adjusts the speed. Pump flow, MAP, and HR are estimated from actuator drive parameters (speed and power). Evaluation of control was performed using a centrifugal blood pump in a hybrid cardiovascular simulator, where the left heart function is the mechanical model and right heart function is the computational model. The control system was able to maintain MAP and cardiac output in the physiological level, even under variation of EF. Apart from this, also the rotational pump speed is adjusted following the simulated clinical condition. No backflow from the aorta in the ventricle occurred through LVAD during tests. The control algorithm results were considered satisfactory for simulations, but it still should be confirmed during in vivo tests.

The Influence of Impeller Geometries on Hemolysis in Bearingless Centrifugal Pumps.

Goal: The importance of the main impeller design parameters in bearingless centrifugal pumps with respect to hemolysis for cardiopulmonary bypass (CPB) and extracorporeal membrane oxygenation (ECMO) applications are studied in this work. Methods: Impeller prototypes were designed based on theoretical principles. They were manufactured and their hydraulic and hemolytic performance were analyzed experimentally. The cell compatibility is benchmarked against commercially available centrifugal blood pumps BPX-80 (Medtronic) and FloPump 32 (International Biophysics Corporation). Results: The developed prototypes outperform the BPX-80 and FloPump 32 with regard to hemocompatibility by more than a factor of 4.5. The implemented pump features reduced overall and priming volumes. A significant improvement of the cell compatibility is achieved by increasing the radial gap between the impeller and the pump head. The blade should be sufficiently high and a blade outlet angle of 90° provides favorable performance. No correlation between the hydraulic and hemolytic performance is observed. Conclusions: This work identified the most important geometrical parameters of the impeller for blood pumps with respect to cell compatibility. This provides valuable design guidelines for improving existing pumps.

Do we have an one-size-fit-all centrifugal blood pump for mechanical circulatory support?

Do we have an one-size-fit-all centrifugal blood pump for mechanical circulatory support?

ニューラルネットワークを用いた動圧浮上遠心血液ポンプの軸受性能の改善

ニューラルネットワークを用いた動圧浮上遠心血液ポンプの軸受性能の改善

Influence of Impeller Speed Patterns on Hemodynamic Characteristics and Hemolysis of the Blood Pump

A continuous-flow output mode of a rotary blood pump reduces the fluctuation range of arterial blood pressure and easily causes complications. For a centrifugal rotary blood pump, sinusoidal and pulsatile speed patterns are designed using the impeller speed modulation. This study aimed to analyze the hemodynamic characteristics and hemolysis of different speed patterns of a blood pump in patients with heart failure using computational fluid dynamics (CFD) and the lumped parameter model (LPM). The results showed that the impeller with three speed patterns (including the constant speed pattern) met the normal blood demand of the human body. The pulsating flow generated by the impeller speed modulation effectively increased the maximum pulse pressure (PP) to 12.7 mm Hg, but the hemolysis index (HI) in the sinusoidal and pulsatile speed patterns was higher than that in the constant speed pattern, which was about 2.1 × 10−5. The flow path of the pulsating flow field in the spiral groove of the hydrodynamic suspension bearing was uniform, but the alternating high shear stress (0~157 Pa) was caused by the impeller speed modulation, causing blood damage. Therefore, the rational modulation of the impeller speed and the structural optimization of a blood pump are important for improving hydrodynamic characteristics and hemolysis.

A Short-Term In Vivo Evaluation of the Istanbul Heart Left Ventricular Assist Device in a Pig Model.

A continuous-flow centrifugal blood pump system has been recently developed as an implantable left ventricular assist device for patients with endstage heart failure. The objective of this study was to evaluate the initial in vivo performance of a newly developed left ventricular assist device (iHeart or Istanbul heart; Manufacturing and Automation Research Center, Koc University, Istanbul, Turkey) in an acute setting using a pig model. Three pigs (77, 83, 92 kg) received implants via a median sternotomy, with animals supported for up to 6 hours. An outflow cannula was anastomosed to the ascending aorta. Anticoagulation was applied by intravenous heparin administration. During the support period, pump performance was evaluated under several flow and operating conditions. All pigs were humanely sacrificied after the experiments, and organs were examined macroscopically and histopathologically. Flow rate ranged between 1.5 and 3.6 L/min with pump speeds of 1500 to 2800 revolutions/min and motor current of 0.6 to 1.3 A. Initial findings confirmed thatthe iHeart ventricular assist device had sufficient hydraulic performance to support the circulation. During the experimental period, plasma free hemoglobin levels were found to be within normalranges.Thrombus formation was not observed inside the pump in all experiments. The iHeart ventricular assist device demonstrated encouraging hemodynamic performance and good biocompatibility in the pig model for use as an implantable left ventricular assist device. Further acute in vivo studies will evaluate the short-term pump performance prior to chronic studies for long-term evaluation.

Mechanical antithrombogenic properties by vibrational excitation of the impeller in a magnetically levitated centrifugal blood pump.

Mechanical circulatory support devices have been used clinically for patients with heart failure for over 10years. However, thrombus formation inside blood pumps remains a risk to patient life, causing pump failure and contributing to neurological damage through embolization. In this article, we propose a method for preventing thrombus formation by applying vibrational excitation to the impeller. We evaluate the ability of this method to enhance the antithrombogenic properties of a magnetically levitated centrifugal blood pump and ensure that the impeller vibration does not cause undue hemolysis. First, 3 vibrational conditions were compared using an isolated pump without a mock circulation loop; the vibrational excitation frequencies and amplitudes for the impeller were set to (a) 0Hz-0μm, (b) 70Hz-10μm, and (c) 300Hz-2.5μm. The motor torque was measured to detect thrombus formation and obtain blood coagulation time by calculating the derivative of the torque. Upon thrombus detection, the pump was stopped and thrombi size were evaluated. The results showed an increase in the blood coagulation time and a decrease in the rate of thrombus formation in pumps with the impeller vibration. Second, an in vitro hemolysis test was performed for each vibrational condition to determine the effect of impeller vibration on hemolysis. The results revealed that there was no significant difference in hemolysis levels between each condition. Finally, the selected vibration based on the above test results and the non-vibration as control were compared to investigate antithrombogenic properties under the continuous flow condition. The blood coagulation time and thrombi size were investigated. As a result, vibrational excitation of the impeller at a frequency of 300Hz and amplitude of 2.5μm was found to significantly lengthen clotting time, decreasing the rate of pump thrombus compared to the non-vibration condition. We indicate the potential of impeller vibration as a novel mechanical antithrombogenic mechanism for rotary blood pumps.

Numerical simulation of centrifugal and hemodynamically levitated LVAD for performance improvement.

Left ventricular assist device (LVAD) provides an effective artificial support system to the heart patients. Despite the improved life survival rate, complications like hemolysis, blood trauma, and thrombus formation still limit the performance of the blood pump. The geometrical aspects of blood pumps majorly influence the hemodynamics, therefore these devices must be carefully engineered. In this work, several versions of centrifugal blood pumps are simulated using ANSYS-CFX to propose a best compatible design for LVAD. A hemodynamic levitation approach for the impeller is also suggested to overcome the cost and weight issue associated with the magnetic levitation. The blood flow is modeled by implementing Bird-Carreau model and its turbulence is solved using the SST turbulence model. The influence of the blade profile, blade tip width, blade numbers, and splitter blades on the hemodynamic characteristics through the pump is observed. An optimum design of centrifugal blood pump for the assistance of failed ventricle is proposed that can effectively pump the blood from the left ventricle to the ascending aorta. The proposal can be adopted by LVAD designers to have hemodynamically tuned efficient product.

Modeling sensitivity and uncertainties in platelet activation models applied on centrifugal pumps for extracorporeal life support

Two platelet activation models were studied with respect to uncertainties of model parameters and variables. The sensitivity was assessed using two direct/deterministic approaches as well as the statistical Monte Carlo method. The first two, are linear in character whereas the latter is non-linear. The platelet activation models were applied on platelets moving within an extracorporeal centrifugal blood pump. The phenomenological, Lagrangian stress- and time-based power law-based models under consideration, have experimentally calibrated parameters and the stress expressed in a scalar form. The sensitivity of the model with respect to model parameters and the expression of the scalar stress was examined focusing on a smaller group of platelets associated with an elevated risk of activation. The results showed a high disparity between the models in terms of platelet activation state, found to depend on the platelets’ trajectory in the pump and the expression used for the scalar stress. Monte Carlo statistics was applied to the platelets at risk for activation and not to the entire platelet population. The method reveals the non-linear sensitivity of the activation models. The results imply that power-law based models have a restricted range of validity. The conclusions of this study apply to both platelet activation and hemolysis models.

On the performance and accuracy of PFEM-2 in the solution of biomedical benchmarks

In recent years, the biomedical industry has shown increased interest in using numerical methods to assist in the R&D of medical devices. The long-term goal is to reduce the costly and lengthy process that clinical trials take for the US Food and Drug Administration (FDA) to approve a medical device. For this reason, both the FDA and academia are working together to create laboratory experiments that will help the industry gain confidence in numerical techniques as well as provide software developers with insights into the strengths and weaknesses of numerical software. In this article, three benchmarks proposed by the FDA are used to compare experimental results with those of a finite element method formulation and enhanced particle finite element method (PFEM-2). The first benchmark problem is the flow in a nozzle containing both, a gradual and a sudden change in diameter with the goal of predicting hemolysis (not studied in this work). The second problem studies the flow in a simplified centrifugal blood pump under various operation conditions. Finally, the third benchmark studies the steady flow in a patient-averaged inferior vena cava. PFEM-2 is regarded as a tool with great potential, mainly because no stabilization is needed for the Galerkin approximation of the advection term in the transport equations. This could be a big advantage in problems with flows at high Reynolds number. The improved time integration along streamlines provide a more accurate way to analyze a problem with a large time step. This paper is an effort to test PFEM-2 in engineering applications.

Assessing Computational Model Credibility Using a Risk-Based Framework: Application to Hemolysis in Centrifugal Blood Pumps.

Medical device manufacturers using computational modeling to support their device designs have traditionally been guided by internally developed modeling best practices. A lack of consensus on the evidentiary bar for model validation has hindered broader acceptance, particularly in regulatory areas. This has motivated the US Food and Drug Administration and the American Society of Mechanical Engineers (ASME), in partnership with medical device companies and software providers, to develop a structured approach for establishing the credibility of computational models for a specific use. Charged with this mission, the ASME V&V 40 Subcommittee on Verification and Validation (V&V) in Computational Modeling of Medical Devices developed a risk-informed credibility assessment framework; the main tenet of the framework is that the credibility requirements of a computational model should be commensurate with the risk associated with model use. This article provides an overview of the ASME V&V 40 standard and an example of the framework applied to a generic centrifugal blood pump, emphasizing how experimental evidence from in vitro testing can support computational modeling for device evaluation. Two different contexts of use for the same model are presented, which illustrate how model risk impacts the requirements on the V&V activities and outcomes.

A Novel Rotary Blood Pump for HFpEF

Purpose Heart Failure with preserved ejection fraction (HFpEF) currently has no treatment options for improving symptoms or survival. We have developed a long-term novel pulsed assist device for treatment of patients with HFpEF. Methods We have developed a small diagonal centrifugal rotary blood pump which utilizes hydrodynamic suspension for magnetically elevated support of a four-blade impeller with partial unloading from the left atrium (LA) to the descending aorta. The pump is adaptive: the physiological needs of the patient are adjusted by both ECG and sensor feedback algorithms. Pulsed power and speed (rpm) maintain pulse pressure at a normal level. The device is designed for minimally invasive Implantation through a 9 × 3 cm thoracotomy. Repeated animal testing (sheeps) is performed. Results Animal studies testing a spectrum of unloading with simultanous hemodynamic and echocardiographic monitoring, have demonstrated adequate pulsed pump unloading between 1.5-3.0 l/min. ECG gated rpm increase in systole avoids LA suction, interference with mitral valve opening and ventricular filling. Blood pressure was maintained at 95-70 mmHg, central venous pressure (CVP) at 10 mmHg and native cardiac output of 3 l/m. Repeated studies with human whole blood without added anticoagulation in a mock loop for 8 hours have demonstrated no hemolysis, no increase in energy consumption or heat, and no clotting inside the pump. Long-term animal studies are planned. Conclusion Partial systolic pulsed unloading of the LA using a novel rotary blood pump demonstrated adequate hemodynamics and maintained normal pulse pressure. This novel pump may become the first possible treatment for patients with HFpEF.

Flow rate estimation of a centrifugal blood pump using the passively stabilized eccentric position of a magnetically levitated impeller.

Flow rate estimation for ventricular assist devices without additional flow sensors can improve the quality of life of patients. In this article, a novel flow estimation method using the passively stabilized displacement of a magnetically levitated impeller is developed to achieve sufficient accuracy and precision of flow estimation for ventricular assist devices in a simple manner. The magnetically levitated impeller used is axially suspended by a magnetic bearing in a centrifugal blood pump that has been developed by our group. The radial displacement of the impeller, which is restricted by passive stability, can be correlated with the flow rate because the radial hydraulic force on the impeller varies according to the flow rate. To obtain the correlation with various blood viscosities, the relationships between the radial displacements of the magnetically levitated impeller and the pressure head-flow rate characteristics of the pump were determined simultaneously using aqueous solutions of glycerol with a potential blood viscosity range. The measurement results showed that accurate steady flow rates could be estimated with a coefficient of determination of approximately 0.97 and mean absolute error of approximately 0.22 L/min without fluid viscosity measurements by using the relationships between the impeller displacement and the flow rate. Moreover, a precision of approximately 0.01 (L/min)/µm was obtained owing to a strong estimation indicator signal provided by the large displacement of the passively stabilized impeller; thus, the proposed estimation method can help ensure sufficient accuracy and precision for ventricular assist devices in a simple manner, even if the blood viscosity is unknown.