Hybrid Continuous-Flow Total Artificial Heart.

Clinical studies using total artificial hearts (TAHs) have demonstrated that pediatric and adult patients derive quality-of-life benefits from this form of therapy. Two clinically-approved TAHs and other pumps under development, however, have design challenges and limitations, including thromboembolic events, neurologic impairment, infection risk due to large size and percutaneous drivelines, and lack of ambulation, to name a few. To address these limitations, we are developing a hybrid-design, continuous-flow, implantable or extracorporeal, magnetically-levitated TAH for pediatric and adult patients with heart failure. This TAH has only two moving parts: an axial impeller for the pulmonary circulation and a centrifugal impeller for the systemic circulation. This device will utilize the latest generation of magnetic bearing technology. Initial geometries were established using pump design equations, and computational modeling provided insight into pump performance. The designs were the basis for prototype manufacturing and hydraulic testing. The study results demonstrate that the TAH is capable of delivering target blood flow rates of 1-6.5 L/min with pressure rises of 1-92 mm Hg for the pulmonary circulation and 24-150 mm Hg for the systemic circulation at 1500-10 000 rpm. This initial design of the TAH was successful and serves as the foundation to continue its development as a novel, more compact, nonthrombogenic, and effective therapeutic alternative for infants, children, adolescents, and adults with heart failure.

Total Artificial Hearts-Past, Current, and Future.

We present a review of the evolution of total artificial hearts (TAHs) and new directions in development, including the coupling of VADs as biventricular TAH support.

Lifeflow vad: design and numerical modeling of magnetic bearing system.

The non-contact and lubrication free support of magnetic bearings make them ideal to support rotating machines. One area of application of magnetic bearings is in the design of the mechanical heart pumps. The LifeFlow heart pump developed by the University of Virginia is one such heart pump which uses active and passive magnetic bearings to support the impeller. The design and controls of such bearings can be quite challenging. One of the major difficulties that one may encounter in designing the controller is to get accurate values of the control parameters such as bias flux, radial and axial stiffness values, forces, etc. In order to obtain these parameters accurately, a three dimensional finite element analysis of the magnetic bearings is crucial. This paper covers the analysis of the magnetic bearing system used in the LifeFlow Heart pump. The main purpose of the analysis was to provide accurate values of air gap flux, forces, radial and axial stiffness in order to design a robust and optimized controller for the bearings. As a result of the analysis, these parameters have been determined and the motor is being redesigned with a smaller footprint to achieve higher efficiency.

Method of backflow reduction in ventricular assist devices.

Ventricular assist devices (VADs) have been developed to augment the deteriorating heart function of those suffering from end-stage congestive heart failure. While these devices have the potential to extend the life span and improve the quality of life of their recipients, they are also susceptible to mechanical failure. In the case of many known VADs, pump failure allows blood to flow retrograde through the device leading to a rapid loss of systemic pressure and loss of life. Some devices, such as heart valves, have been implemented to reduce or eliminate the potential for backflow in VADs but almost always at the expense of making the system more prone to thromboembolism or less reliable overall. This study presents a novel method of reducing backflow in a stopped VAD without significantly increasing the risk of thromboembolism or failure of the system. A combination of computational analysis and experimental testing was used for this study. The device design was evaluated with the extensive use of CFD and fluid-solid interaction modeling for predicting thrombus initiation potentials and mechanical and fluid stresses within the device. These results were then used in an optimization loop to parametrically evaluate the design geometry. Mock-loop experiments with a prototype provided validation of the CFD calculations. Additionally, the device design was evaluated for manufacturability with blood compatible materials and suitable surfacing techniques. The CFD numerical estimations generally agree with the experimental measurements over the entire range of backflow situations tested. Streamline analysis reveals no recirculation regions within the device. Velocity and residence time plots also demonstrated low indicators for thrombosis. Initial prototype tests validate the working principle of the device.

Numerical evaluation of blood damage in a magnetically levitated heart pump - biomed 2009.

The prospect of Ventricular Assist Devices used for long-term support of congestive heart failure patients is directly dependent upon excellent blood compatibility. High fluid stress levels may arise due to high rotational speeds and narrow clearances between the stationary and rotating parts of the pump. Thus, fluid stress may result in damage to red blood cells and activation of platelets, contributing to thrombus formation. Therefore, it is essential to evaluate levels of blood trauma for successful design of a Ventricular Assist Device. Estimating the fluid stress levels that occur in a blood pump during the design phase also provides valuable information for optimization considerations. This study describes the CFD evaluation of blood damage in a magnetically suspended axial pump that occurs due to fluid stress. Using CFD, a blood damage index, reflecting the percentage of damaged red blood cells, was numerically estimated based on the scalar fluid stress values and exposure time to such stresses. A number of particles, with no mass and reactive properties, was injected at the inflow of the computational domain at a time t = 0 and traveled along their corresponding streamlines. A Lagrangian particle tracking technique was employed to obtain the stress history of each particle along its streamline, making it possible to consider the damage history of each particle. Maximum scalar stresses of approximately 430 Pa were estimated to occur along the tip surface of the impeller blades, more precisely at the leading edge of the impeller blades. The maximum time required for the vast majority of particles to pass through the pump was approximately 0.085sec. A small number of particles approximately 5%), which traveled through the narrow gap between the stationary and rotating part of the pump, exited the computational domain in approximately 0.2 sec. The mean value of blood damage index was found to be 0.15% with a maximum value of approximately 0.47%. These values are one order of magnitude lower than the approximated damage indices published in the literature for other Ventricular Assist Devices. The low blood damage index indicates that red blood cells traveling along the streamlines considered are not likely to be ruptured, mainly due to the very small time of exposure to high stress.

Gait synchronized force modulation during the stance period of one limb achieved by an active partial body weight support system.

Our purpose was to demonstrate the ability of an actively controlled partial body weight support (PBWS) system to provide gait synchronized support during the stance period of a single lower extremity while examining the affect of such a support condition on gait asymmetry. Using an instrumented treadmill and a motion capture system, we compared gait parameters of twelve healthy elderly subjects (age 65-80 years) during unsupported walking to those while walking with 20% body weight support provided during only the stance period of the right limb. Specifically, we examined peak three-dimensional ground reaction force (GRF) data and the symmetry of lower extremity sagittal plane joint angles and of time and distance parameters. A reduction in all three GRF components was observed for the supported limb during modulated support. Reductions observed in the vertical GRF were comparable to the desired 20% support level. Additionally, GRF components examined for the unsupported limb during modulated support were consistently similar to those measured during unsupported walking. Modulated support caused statistically significant increases in asymmetry for knee flexion during stance (increased 5.9%), hip flexion during late swing (increased 9.1%), and the duration of single limb support (increased 2.8%). However, the observed increases were similar or considerably less than the natural variability in the asymmetry of these parameters during unsupported walking. The ability of the active PBWS device to provide unilateral support may offer new and possibly improved applications of PBWS rehabilitation for patients with unilateral walking deficits such as hemiparesis or orthopaedic injury.

Implantable axialflow blood pump for left ventricular support.

Artificial blood pumps, either ventricular assist devices (VADs) or total artificial hearts, are currently employed for bridge to recovery, bridge to transplant, and destination therapy situations. The clinical effectiveness of VADs has been demonstrated; however, all of the currently available pumps have a limited life because of either the damage they cause to blood or their limited mechanical design life. A magnetically suspended rotary blood pump offers the potential to meet the requirements of both extending design life and causing negligible blood damage due to superior hemodynamics. Therefore, over the last few years, efforts of an interdisciplinary research team at University of Virginia have been concentrated on the design and development of a fully implantable axial flow VAD with a magnetically levitated impeller (LEV-VAD). This paper details the second generation developmental prototype (LEV-VAD2 design configuration) and includes a complete CFD analysis of device performance. Based on encouraging results of the first design stage, including a good agreement between the CFD performance estimations and the experimental measurements, a second design phase was initiated in an attempt to enhance device flow performance and suspension system capabilities. Using iterative design optimization stages, the design of the impeller and the geometry of the stationary and rotating blades have been reevaluated. A thorough CFD analysis allowed for optimization of the blood flow path such that an optimal trade-off among the hydraulic performance, specific requirements of a blood pump, and manufacturing requirements has been achieved. Per the CFD results, the LEV-VAD2 produces 6 lpm and 100 mmHg at a rotational speed of 7,000 rpm. The pressure-flow performance predictions indicate the LEV-VAD2's ability to deliver adequate flow over physiologic pressures for rotational speeds varying from 5,000 to 8,000 rpm. The blood damage numerical predictions also demonstrate acceptable levels. The axial and radial forces estimated from the computational analysis are well within the range for which the magnetic suspension and motor configuration can compensate. As a consequence of this favorable performance, the current design configuration has been selected for prototype manufacturing and further experimental testing.

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.

Physiological modulation of gait variables by an active partial body weight support system.

Partial body weight support (PBWS) systems used for rehabilitation status post-neurological and musculoskeletal pathologies and injuries are traditionally passive. Our purpose was to demonstrate the ability of an actively controlled PBWS system to provide a clinically relevant modulated support condition while investigating the impact of such a condition on the dynamics of gait. Using an instrumented treadmill and a motion capture system, we compared gait parameters of six healthy young adults (age 24-31 years) during unsupported walking to those under the assistance of two support conditions (a constant 20% body weight support, and a modulated support providing 20% body weight support during the loading response of each leg while allowing for an unsupported terminal stance). The modulated condition achieved support synchronized to gait cycle events with mean and maximum loading errors at the 20% body weight support level equal to 1.01 and 2.44 kg, respectively. Constant support significantly reduced sagittal plane hip angle range of motion and increased ankle platarflexion as compared to unsupported walking (p < 0.05). Also, a clear trend of decreased stride length was observed for constant support. No significant differences in these parameters were evident between the modulated support condition and unsupported walking. Ankle power generation and absorption both significantly decreased under constant support. The modulated support condition significantly increased ankle power absorption though showed no change in ankle power generation. The ability of the presented active PBWS device to provide individualized support schemes may offer new and possibly improved applications of PBWS rehabilitation.

Fluid force predictions and experimental measurements for a magnetically levitated pediatric ventricular assist device.

The latest generation of artificial blood pumps incorporates the use of magnetic bearings to levitate the rotating component of the pump, the impeller. A magnetic suspension prevents the rotating impeller from contacting the internal surfaces of the pump and reduces regions of stagnant and high shear flow that surround fluid or mechanical bearings. Applying this third-generation technology, the Virginia Artificial Heart Institute has developed a ventricular assist device (VAD) to support infants and children. In consideration of the suspension design, the axial and radial fluid forces exerted on the rotor of the pediatric VAD were estimated using computational fluid dynamics (CFD) such that fluid perturbations would be counterbalanced. In addition, a prototype was built for experimental measurements of the axial fluid forces and estimations of the radial fluid forces during operation using a blood analog mixture. The axial fluid forces for a centered impeller position were found to range from 0.5 +/- 0.01 to 1 +/- 0.02 N in magnitude for 0.5 +/- 0.095 to 3.5 +/- 0.164 Lpm over rotational speeds of 6110 +/- 0.39 to 8030 +/- 0.57% rpm. The CFD predictions for the axial forces deviated from the experimental data by approximately 8.5% with a maximum difference of 18% at higher flow rates. Similarly for the off-centered impeller conditions, the maximum radial fluid force along the y-axis was found to be -0.57 +/- 0.17 N. The maximum cross-coupling force in the x direction was found to be larger with a maximum value of 0.74 +/- 0.22 N. This resulted in a 25-35% overestimate of the radial fluid force as compared to the CFD predictions; this overestimation will lead to a far more robust magnetic suspension design. The axial and radial forces estimated from the computational results are well within a range over which a compact magnetic suspension can compensate for flow perturbations. This study also serves as an effective and novel design methodology for blood pump developers employing magnetic suspensions. Following a final design evaluation, a magnetically suspended pediatric VAD will be constructed for extensive hydraulic and animal testing as well as additional validation of this design methodology.

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.

Optimization of an axial flow heart pump with active and passive magnetic bearings.

Optimization of a magnetically suspended left ventricular assist device (LVAD) is crucial. We desire a totally implantable, long-life LVAD that delivers the necessary flow rate, pressure rise, and blood compatibility. By using a novel combination of passive and active magnetic bearings (AMBs), we have developed an axial flow LVAD prototype, the LEV-VAD, which provides an unobstructed blood flow path, preventing stagnation regions for the blood. Our current effort is focused on the optimization of the magnetic suspension system to allow for control of the AMB, minimizing its size and power consumption. The properties of the passive magnetic bearings and AMBs serve as parameter space, over which a cost function is minimized, subject to constraints such as suspension stability and sufficient disturbance rejection capabilities. The design process is expected to lead to the construction of a small prototype pump along with the necessary robust controller for the AMB. Sensitivity of the LVAD performance with respect to various design parameters is examined in-depth and an optimized, more compact LVAD prototype is designed.

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.

Center of mass movement and energy transfer during walking in children with cerebral palsy.

OBJECTIVE: To gain insight into the mechanical inefficiencies of gait patterns used by children with spastic diplegia by analysis of center of mass (COM) movement and energy recovery. DESIGN: Prospective study using between-group measures to analyze differences between children with cerebral palsy (CP) and age-matched controls without CP. SETTING: Assessments were performed in a gait laboratory. PARTICIPANTS: Fifteen children with spastic diplegia and 6 age-matched controls without CP with a mean age of 9.7 years. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Gait data assessed included temporal-distance factors, COM vertical excursion, work done on the COM, and the percentage of energy transferred and relative phase between the potential and kinetic energy. RESULTS: Children with CP had a 33% smaller energy recovery factor than the controls (P<.001). They also had 60% greater COM vertical excursion (P<.02) and a poorer phasic relation between potential and kinetic energies (P<.02), both of which contributed to greater mechanical work performed (P<.003). CONCLUSIONS: Compared with the age-matched controls without CP, the children with CP were mechanically less efficient in their gait. Interventions that promote heel contact and roll over and greater knee stability to better utilize the kinetic energy of push-off could improve walking efficiency.

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.