title: PediaFlow™ Maglev Ventricular Assist Device: A Prescriptive Design Approach.
abstract: This report describes a multi-disciplinary program to develop a pediatric blood pump, motivated by the critical need to treat infants and young children with congenital and acquired heart diseases. The unique challenges of this patient population require a device with exceptional biocompatibility, miniaturized for implantation up to 6 months. This program implemented a collaborative, prescriptive design process, whereby mathematical models of the governing physics were coupled with numerical optimization to achieve a favorable compromise among several competing design objectives. Computational simulations of fluid dynamics, electromagnetics, and rotordynamics were performed in two stages: first using reduced-order formulations to permit rapid optimization of the key design parameters; followed by rigorous CFD and FEA simulations for calibration, validation, and detailed optimization. Over 20 design configurations were initially considered, leading to three pump topologies, judged on the basis of a multi-component analysis including criteria for anatomic fit, performance, biocompatibility, reliability, and manufacturability. This led to fabrication of a mixed-flow magnetically levitated pump, the PF3, having a displaced volume of 16.6 cc, approximating the size of a AA battery and producing a flow capacity of 0.3-1.5 L/min. Initial in vivo evaluation demonstrated excellent hemocompatibility after 72 days of implantation in an ovine. In summary, combination of prescriptive and heuristic design principles have proven effective in developing a miniature magnetically levitated blood pump with excellent performance and biocompatibility, suitable for integration into chronic circulatory support system for infants and young children; aiming for a clinical trial within 3 years.
authors.affiliation: Biomedical Engineering, Carnegie Mellon University, Pittsburgh, PA, USA.
authors.forename: James F
authors.initials: JF
authors.lastname: Antaki
authors.forename: Michael R
authors.initials: MR
authors.lastname: Ricci
authors.forename: Josiah E
authors.initials: JE
authors.lastname: Verkaik
authors.forename: Shaun T
authors.initials: ST
authors.lastname: Snyder
authors.forename: Timothy M
authors.initials: TM
authors.lastname: Maul
authors.forename: Jeongho
authors.initials: J
authors.lastname: Kim
authors.forename: Dave B
authors.initials: DB
authors.lastname: Paden
authors.forename: Marina V
authors.initials: MV
authors.lastname: Kameneva
authors.forename: Bradley E
authors.initials: BE
authors.lastname: Paden
authors.forename: Peter D
authors.initials: PD
authors.lastname: Wearden
authors.forename: Harvey S
authors.initials: HS
authors.lastname: Borovetz