Miniaturization of a magnetically levitated axial flow blood pump.

This article introduces a unique miniaturization process of a magnetically levitated axial flow blood pump from a functional prototype to a pump suitable for animal trials. Through COMSOL three-dimensional finite element analysis and experimental verification, the hybrid magnetic bearings of the pump have been miniaturized, the axial spacing between magnetic components has been reduced, and excess material in mechanical components of the pump was reduced. Experimental results show that the pump performance was virtually unchanged and the smaller size resulted in the successful acute pump implantation in calves.

Numerical design and experimental hydraulic testing of an axial flow ventricular assist device for infants and children.

Mechanical circulatory support options for infants and children are very limited in the United States. Existing circulatory support systems have proven successful for short-term pediatric assist, but are not completely successful as a bridge-to-transplant or bridge-to-recovery. To address this substantial need for alternative pediatric mechanical assist, we are developing a novel, magnetically levitated, axial flow pediatric ventricular assist device (PVAD) intended for longer-term ventricular support. Three major numerical design and optimization phases have been completed. A prototype was built based on the latest numerical design (PVAD3) and hydraulically tested in a flow loop. The plastic PVAD prototype delivered 0.5-4 lpm, generating pressure rises of 50-115 mm Hg for operating speeds of 6,000-9,000 rpm. The experimental testing data and the numerical predictions correlated well. The error between these sets of data was found to be generally 7.8% with a maximum deviation of 24% at higher flow rates. The axial fluid forces for the numerical simulations ranged from 0.5 to 1 N and deviated from the experimental results by generally 8.5% with a maximum deviation of 12% at higher flow rates. These hydraulic results demonstrate the excellent performance of the PVAD3 and illustrate the achievement of the design objectives.

Time course of esophageal lesions after catheter ablation with cryothermal and radiofrequency ablation: implication for atrio-esophageal fistula formation after catheter ablation for atrial fibrillation.

BACKGROUND: Atrio-esophageal fistulas have been described as a consequence of radiofrequency (RF) ablation for the treatment of atrial fibrillation (AF). However, whether cryoablation can avoid this potential fatal complication remains unclear. METHODS AND RESULTS: We studied the effects of direct application of RF and cryoablation on the cervical esophagus in 16 calves. Cryoablation was performed with a 6.5-mm catheter probe using a single 5-minute freeze at <-80 degrees C, and RF ablation was delivered with an 8-mm catheter electrode at 50 W and 50 degrees C for 45-60 seconds. Histopathologic assessments were performed at 1, 4, 7, and 14 day(s) after completion of the ablation protocol: four animals were examined each day. A total of 85 direct esophageal ablations were performed: 41 with RF and 44 with cryoablation. There were no significant differences in lesion width, depth, or volume between cryoablation and RF ablation at Day 1, 4, and 14 after the procedure (P > 0.05). However, lesion width and volume were significantly larger with RF than with cryoablation at Day 7. Although acute (Day 1) and chronic (Day 14) RF and cryoablation lesions were of comparable size, histologic evidence of partial- to full-wall esophageal lesion ulceration was observed in 0 of 44 (0%) lesions with cryoablation, compared with 9 of 41 (22%) lesions with RF ablation (P = 0.0025). CONCLUSIONS: Direct application of cryoablation and RF ablation created similar acute and chronic lesion dimensions on the esophagus. However, cryoablation was associated with a significantly lower risk of esophageal ulceration, compared with RF ablation.

Construction of an artificial heart pump performance test system.

A hydraulic loop, which simulates pressure/flow response of the human circulatory system, is needed to bench test the various versions of rotary left ventricular assist devices (LVADs). This article describes the design of such a loop and the simulated response of different physiological states, such as a healthy person in sleep, rest, and mild physical activity, and in different pathological states. The loop consists of: (1) pulsatile left and right cardiac simulators; (2) air/water tanks to model the venous and arterial compliances; (3) tygon tubes to model the venous, arterial, and other system flow resistances; and (4) a tuning clamp to model the variation in system resistance characteristics under different cardiac pressure/flow conditions. The simulated responses were compared to the data found in the literature to validate the loop performance prior to LVAD testing.

Computational design and experimental testing of a novel axial flow LVAD.

Thousands of cardiac failure patients per year in the United States could benefit from long-term mechanical circulatory support as destination therapy. To provide an improvement over currently available devices, we have designed a fully implantable axial-flow ventricular assist device with a magnetically levitated impeller (LEV-VAD). In contrast to currently available devices, the LEV-VAD has an unobstructed blood flow path and no secondary flow regions, generating substantially less retrograde and stagnant flow. The pump design included the extensive use of conventional pump design equations and computational fluid dynamics (CFD) modeling for predicting pressure-flow curves, hydraulic efficiencies, scalar fluid stress levels, exposure times to such stress, and axial fluid forces exerted on the impeller for the suspension design. Flow performance testing was completed on a plastic prototype of the LEV-VAD for comparison with the CFD predictions. Animal fit trials were completed to determine optimum pump location and cannulae configuration for future acute and long-term animal implantations, providing additional insight into the LEV-VAD configuration and implantability. Per the CFD results, the LEV-VAD produces 6 l/min and 100 mm Hg at a rotational speed of approximately 6300 rpm for steady flow conditions. The pressure-flow performance predictions demonstrated the VAD's ability to deliver adequate flow over physiologic pressures for reasonable rotational speeds with best efficiency points ranging from 25% to 30%. The CFD numerical estimations generally agree within 10% of the experimental measurements over the entire range of rotational speeds tested. Animal fit trials revealed that the LEV-VAD's size and configuration were adequate, requiring no alterations to cannulae configurations for future animal testing. These acceptable performance results for LEV-VAD design support proceeding with manufacturing of a prototype for extensive mock loop and initial acute animal testing.

Computational design and experimental performance testing of an axial-flow pediatric ventricular assist device.

The Virginia Artificial Heart Institute continues to design and develop an axial-flow pediatric ventricular assist device (PVAD) for infants and children in the United States. Our research team has created a database to track potential PVAD candidates at the University of Virginia Children's Hospital. The findings of this database aided with need assessment and design optimization of the PVAD. A numerical analysis of the optimized PVAD1 design (PVAD2 model) was also completed using computational fluid dynamics (CFD) to predict pressure-flow performance, fluid force estimations, and blood damage levels in the flow domain. Based on the PVAD2 model and after alterations to accommodate manufacturing, a plastic prototype for experimental flow testing was constructed via rapid prototyping techniques or stereolithography. CFD predictions demonstrated a pressure rise range of 36-118 mm Hg and axial fluid forces of 0.8-1.7 N for flows of 0.5-3 l/min over 7000-9000 rpm. Blood damage indices per CFD ranged from 0.24% to 0.35% for 200 massless and inert particles analyzed. Approximately 187 (93.5%) of the particles took less than 0.14 seconds to travel completely through the PVAD. The mean residence time was 0.105 seconds with a maximum time of 0.224 seconds. Additionally, in a water/glycerin blood analog solution, the plastic prototype produced pressure rises of 20-160 mm Hg for rotational speeds of 5960 +/- 18 rpm to 9975 +/- 31 rpm over flows from 0.5 to 4.5 l/min. The numerical results for the PVAD2 and the prototype hydraulic testing indicate an acceptable design for the pump, represent a significant step in the development phase of this device, and encourage manufacturing of a magnetically levitated prototype for animal experiments.

The status of failure and reliability testing of artificial blood pumps.

Artificial blood pumps are today's most promising bridge-to-transplant, bridge-to-recovery, and destination therapy solutions for patients with congestive heart failure. There is a critical need for increased reliability and safety as the next generation of artificial blood pumps approach final development for long-term destination therapy. To date, extensive failure and reliability studies of these devices are considered intellectual property and thus remain unpublished. Presently, the Novacor N100PC, Thoratec VAD, and HeartMate LVAS (IP and XVE) comprise the only four artificial blood pumps commercially available for the treatment of congestive heart failure in the United States. The CardioWest TAH recently received premarket approval from the US Food and Drug Administration. With investigational device exemptions, the AB-180, AbioCor, LionHeart, DeBakey, and Flowmaker are approved for clinical testing. Other blood pumps, such as the American BioMed-Baylor TAH, CorAide, Cleveland Clinic-Nimbus TAH, HeartMate III, Hemadyne, and MagScrew TAH are currently in various stages of mock loop and animal testing, as indicated in published literature. This article extensively reviews in vitro testing, in vivo testing, and the early clinical testing of artificial blood pumps in the United States, as it relates to failure and reliability. This detailed literature review has not been published before and provides a thorough documentation of available data and testing procedures regarding failure and reliability of these various pumps.

Numerical and experimental analysis of an axial flow left ventricular assist device: the influence of the diffuser on overall pump performance.

Thousands of adult cardiac failure patients may benefit from the availability of an effective, long-term ventricular assist device (VAD). We have developed a fully implantable, axial flow VAD (LEV-VAD) with a magnetically levitated impeller as a viable option for these patients. This pump's streamlined and unobstructed blood flow path provides its unique design and facilitates continuous washing of all surfaces contacting blood. One internal fluid contacting region, the diffuser, is extremely important to the pump's ability to produce adequate pressure but is challenging to manufacture, depending on the complex blade geometries. This study examines the influence of the diffuser on the overall LEV-VAD performance. A combination of theoretical analyses, computational fluid (CFD) simulations, and experimental testing was performed for three different diffuser models: six-bladed, three-bladed, and no-blade configuration. The diffuser configurations were computationally and experimentally investigated for flow rates of 2-10 L/min at rotational speeds of 5000-8000 rpm. For these operating conditions, CFD simulations predicted the LEV-VAD to deliver physiologic pressures with hydraulic efficiencies of 15-32%. These numerical performance results generally agreed within 10% of the experimental measurements over the entire range of rotational speeds tested. Maximum scalar stress levels were estimated to be 450 Pa for 6 L/min at 8000 rpm along the blade tip surface of the impeller. Streakline analysis demonstrated maximum fluid residence times of 200 ms with a majority of particles exiting the pump in 80 ms. Axial fluid forces remained well within counter force generation capabilities of the magnetic suspension design. The no-bladed configuration generated an unacceptable hydraulic performance. The six-diffuser-blade model produced a flow rate of 6 L/min against 100 mm Hg for 6000 rpm rotational speed, while the three-diffuser-blade model produced the same flow rate and pressure rise for a rotational speed of 6500 rpm. The three-bladed diffuser configuration was selected over the six-bladed, requiring only an incremental adjustment in revolution per minute to compensate for and ease manufacturing constraints. The acceptable results of the computational simulations and experimental testing encourage final prototype manufacturing for acute and chronic animal studies.

Design and initial testing of a mock human circulatory loop for left ventricular assist device performance testing.

A mock circulatory loop, which simulates the human circulatory system, is needed to bench test the various versions of continuous flow (CF) left ventricular assist devices (LVADs). This article describes the design and initial testing of such a loop. The loop consists of: (1) pulsatile left and right cardiac simulators; (2) air/water tanks to model the venous and arterial compliances; (3) tygon tubes to model the venous, arterial, and other system flow resistances; and (4) a tuning clamp to model the variation in system resistance characteristics under different cardiac pressure/flow conditions. Several loop measurements were carried out without an LVAD to verify the cardiovascular modeling of a healthy person in sleep, rest, and physical activity, and in different pathological states, and compared to the data found in the literature to validate the loop performance prior to LVAD testing.

Methods of failure and reliability assessment for mechanical heart pumps.

Artificial blood pumps are today's most promising bridge-to-recovery (BTR), bridge-to-transplant (BTT), and destination therapy solutions for patients suffering from intractable congestive heart failure (CHF). Due to an increased need for effective, reliable, and safe long-term artificial blood pumps, each new design must undergo failure and reliability testing, an important step prior to approval from the United States Food and Drug Administration (FDA), for clinical testing and commercial use. The FDA has established no specific standards or protocols for these testing procedures and there are only limited recommendations provided by the scientific community when testing an overall blood pump system and individual system components. Product development of any medical device must follow a systematic and logical approach. As the most critical aspects of the design phase, failure and reliability assessments aid in the successful evaluation and preparation of medical devices prior to clinical application. The extent of testing, associated costs, and lengthy time durations to execute these experiments justify the need for an early evaluation of failure and reliability. During the design stages of blood pump development, a failure modes and effects analysis (FMEA) should be completed to provide a concise evaluation of the occurrence and frequency of failures and their effects on the overall support system. Following this analysis, testing of any pump typically involves four sequential processes: performance and reliability testing in simple hydraulic or mock circulatory loops, acute and chronic animal experiments, human error analysis, and ultimately, clinical testing. This article presents recommendations for failure and reliability testing based on the National Institutes of Health (NIH), Society for Thoracic Surgeons (STS) and American Society for Artificial Internal Organs (ASAIO), American National Standards Institute (ANSI), the Association for Advancement of Medical Instrumentation (AAMI), and the Bethesda Conference. It further discusses studies that evaluate the failure, reliability, and safety of artificial blood pumps including in vitro and in vivo testing. A descriptive summary of mechanical and human error studies and methods of artificial blood pumps is detailed.

Transient and quasi-steady computational fluid dynamics study of a left ventricular assist device.

The HeartQuest continuous flow left ventricle assist device (LVAD) with a magnetically levitated impeller operates under highly transient flow conditions. Due to insertion of the in-flow cannula into the apex of the left ventricle, the inlet flow rate is transient because of ventricular contraction, and the pump's asymmetric circumferential configuration with five rotating blades forces blood intermittently through the pump to the great arteries. These two transient conditions correspond to time varying boundary conditions and transient rotational sliding interfaces in computational fluid dynamics (CFD). CFD was used to investigate the pump's performance under these dynamic flow conditions. A quasi-steady analysis was also conducted to evaluate the difference between the steady and transient analyses and demonstrate the significance of transient analysis, especially for transient rotational sliding interfaces transient simulations. This transient flow analysis can be applied generally in the design process of LVADs; it provides more reliable fluid forces and moments on the impeller for successful design of the magnetic suspension system and motor.

Computational analysis of an axial flow pediatric ventricular assist device.

Longer-term (>2 weeks) mechanical circulatory support will provide an improved quality of life for thousands of pediatric cardiac failure patients per year in the United States. These pediatric patients suffer from severe congenital or acquired heart disease complicated by congestive heart failure. There are currently very few mechanical circulatory support systems available in the United States as viable options for this population. For that reason, we have designed an axial flow pediatric ventricular assist device (PVAD) with an impeller that is fully suspended by magnetic bearings. As a geometrically similar, smaller scaled version of our axial flow pump for the adult population, the PVAD has a design point of 1.5 L/min at 65 mm Hg to meet the full physiologic needs of pediatric patients. Conventional axial pump design equations and a nondimensional scaling technique were used to estimate the PVAD's initial dimensions, which allowed for the creation of computational models for performance analysis. A computational fluid dynamic analysis of the axial flow PVAD, which measures approximately 65 mm in length by 35 mm in diameter, shows that the pump will produce 1.5 L/min at 65 mm Hg for 8000 rpm. Fluid forces (approximately 1 N) were also determined for the suspension and motor design, and scalar stress values remained below 350 Pa with maximum particle residence times of approximately 0.08 milliseconds in the pump. This initial design demonstrated acceptable performance, thereby encouraging prototype manufacturing for experimental validation.

Inlet and outlet devices for rotary blood pumps.

The purposes of inlet and outlet devices for rotary blood pumps, including inducers and diffusers for axial pumps, inlet and exit volutes for centrifugal pumps, and inlet and outlet cannulas, are to guide the blood into the impeller, where the blood is accelerated, and to convert the high kinetic energy into pressure after the impeller discharge, respectively. The designs of the inlet and outlet devices have an important bearing on the pump performance. Their designs are highly dependent on computational fluid dynamics (CFD) analysis, guided by intuition and experience. For inlet devices, the design objectives are to eliminate separated flow, to minimize recirculation, and to equalize the radial components of velocity. For outlet devices, the design goals are to reduce speed, to minimize energy loss, and to avoid flow separation and whirl. CFD analyses indicate the velocity field and pressure distribution. Geometrical optimization of these components has been implemented in order to improve the flow pattern.

A bridge from short-term to long-term left ventricular assist device--experimental verification of a physiological controller.

A physiological controller is a key component to optimize the performance of left ventricular assist devices (LVADs) from short term to long term (10-20 years). The difficulties of its design lie in the inaccurate modeling of any particular human cardiovascular system because of limited knowledge, the large fluctuation of systemic parameters in normal daily life, nonlinearity introduced by one-way heart valves, and restriction on available sensors. The desired physiological controller for a permanent LVAD is expected to handle different activity levels such as sleeping, resting and exercising, and different pathological levels of left ventricular failure. In this study, a physiological controller designed for a long-term continuous flow (CF) LVAD was tested in a mock circulatory loop. The pressure head across the LVAD and motor signals were used as feedback signals, which were obtained from long-term reliable sensors. Three activities and five different pathological levels of left ventricular failure were simulated to test the performance of the designed controller. The experimental results showed that the designed controller restored the total peripheral flow and arterial pressure, and decreased the left ventricular end-diastolic pressure to a safe range. The suction of the left ventricle was successfully reversed by the designed controller. The controller thus was proven to be able to control the LVAD properly in many of the possible physiological conditions experienced by LVAD recipients in long term.

Computational Fluid Dynamics (CFD) study of the 4th generation prototype of a continuous flow Ventricular Assist Device (VAD).

The continuous flow ventricular assist device (VAD) is a miniature centrifugal pump, fully suspended by magnetic bearings, which is being developed for implantation in humans. The CF4 model is the first actual prototype of the final design product. The overall performances of blood flow in CF4 have been simulated using computational fluid dynamics (CFD) software: CFX, which is commercially available from ANSYS Inc. The flow regions modeled in CF4 include the inlet elbow, the five-blade impeller, the clearance gap below the impeller, and the exit volute. According to different needs from patients, a wide range of flow rates and revolutions per minute (RPM) have been studied. The flow rate-pressure curves are given. The streamlines in the flow field are drawn to detect stagnation points and vortices that could lead to thrombosis. The stress is calculated in the fluid field to estimate potential hemolysis. The stress is elevated to the decreased size of the blood flow paths through the smaller pump, but is still within the safe range. The thermal study on the pump, the blood and the surrounding tissue shows the temperature rise due to magnetoelectric heat sources and thermal dissipation is insignificant. CFD simulation proved valuable to demonstrate and to improve the performance of fluid flow in the design of a small size pump.

An advanced physiological controller design for a left ventricular assist device to prevent left ventricular collapse.

A continuous flow left ventricle assist device (LVAD), which is mainly composed of a continuous flow blood pump and a physiological controller, has only one control input, the rotational speed of the pump, but at least three performance criteria to meet. The challenge for the physiological controller of a long-term continuous flow LVAD is the adaptability to different cardiovascular loading situations and the ability to handle systemic and parametric uncertainties with only one control input. The physiological LVAD controller presented in this article exhibits good performance in terms of the three performance criteria in different physiological loading conditions, such as disturbance, resting, and moderate exercise, for a patient with congestive heart failure. The collapse of the left ventricle, which is an inherent problem for a continuous flow LVAD, has been prevented because of the control algorithm design.

Studies of turbulence models in a computational fluid dynamics model of a blood pump.

Computational fluid dynamics (CFD) is used widely in design of rotary blood pumps. The choice of turbulence model is not obvious and plays an important role on the accuracy of CFD predictions. TASCflow (ANSYS Inc., Canonsburg, PA, U.S.A.) has been used to perform CFD simulations of blood flow in a centrifugal left ventricular assist device; a k-epsilon model with near-wall functions was used in the initial numerical calculation. To improve the simulation, local grids with special distribution to ensure the k-omega model were used. Iterations have been performed to optimize the grid distribution and turbulence modeling and to predict flow performance more accurately comparing to experimental data. A comparison of k-omega model and experimental measurements of the flow field obtained by particle image velocimetry shows better agreement than k-epsilon model does, especially in the near-wall regions.

Computational fluid dynamics prediction of blood damage in a centrifugal pump.

This study explores a quantitative evaluation of blood damage that occurs in a continuous flow left ventricular assist device due to fluid stress. Computational fluid dynamics (CFD) analysis is used to track the shear stress history of 388 particle streaklines. The accumulation of shear and exposure time is integrated along the streaklines to evaluate the levels of blood trauma. This analysis, which includes viscous and turbulent stresses, provides a statistical estimate of possible damage to cells flowing through the pump. In vitro normalized index of hemolysis values for clinically available ventricular assist devices were compared to our damage indices. This allowed for an order of magnitude comparison between our estimations and experimentally measured hemolysis levels, which resulted in a reasonable correlation. This work ultimately demonstrates that CFD is a convenient and effective approach to analyze the Lagranian behavior of blood in a heart assist device.