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.
ABSTRACT
This article describes a design process for a new pediatric ventricular assist device, the PediaFlow. The pump is embodied in a magnetically levitated turbodynamic design that was developed explicitly based on the requirements for chronic support of infants and small children. The procedure entailed the consideration of multiple pump topologies, from which an axial mixed-flow configuration was chosen for further development. The magnetic design includes permanent-magnet (PM) passive bearings for radial support of the rotor, an actively controlled thrust actuator for axial support, and a brushless direct current (DC) motor for rotation. These components are closely coupled both geometrically and magnetically, and were therefore optimized in parallel, using electromagnetic, rotordynamic models and fluid models, and in consideration of hydrodynamic requirements. Multiple design objectives were considered, including efficiency, size, and margin between critical speeds to operating speed. The former depends upon the radial and yaw stiffnesses of the PM bearings. Analytical expressions for the stiffnesses were derived and verified through finite element analysis (FEA). A toroidally wound motor was designed for high efficiency and minimal additional negative radial stiffness. The design process relies heavily on optimization at the component level and system level. The results of this preliminary design optimization yielded a pump design with an overall stability margin of 15%, based on a pressure rise of 100 mm Hg at 0.5 lpm running at 16,000 rpm.
Subject(s)
Equipment Design , Heart-Assist Devices , Magnetics , Biomedical Engineering , Child, Preschool , Finite Element Analysis , Humans , Infant , Infant, Newborn , Models, BiologicalABSTRACT
The very limited options available to treat ventricular failure in children with congenital and acquired heart diseases have motivated the development of a pediatric ventricular assist device at the University of Pittsburgh (UoP) and University of Pittsburgh Medical Center (UPMC). Our effort involves a consortium consisting of UoP, Children's Hospital of Pittsburgh (CHP), Carnegie Mellon University, World Heart Corporation, and LaunchPoint Technologies, Inc. The overall aim of our program is to develop a highly reliable, biocompatible ventricular assist device (VAD) for chronic support (6 months) of the unique and high-risk population of children between 3 and 15 kg (patients from birth to 2 years of age). The innovative pediatric ventricular assist device we are developing is based on a miniature mixed flow turbodynamic pump featuring magnetic levitation, to assure minimal blood trauma and risk of thrombosis. This review article discusses the limitations of current pediatric cardiac assist treatment options and the work to date by our consortium toward the development of a pediatric VAD.
Subject(s)
Heart-Assist Devices , Biocompatible Materials , Child , Extracorporeal Membrane Oxygenation , HumansABSTRACT
The very limited options available to treat ventricular failure in patients with congenital and acquired heart diseases have motivated the development of a pediatric ventricular assist device (VAD). Our effort involves a consortium consisting of the University of Pittsburgh, Carnegie Mellon University, Children's Hospital of Pittsburgh, World Heart Corporation, and LaunchPoint Technologies, LLC. The overall aim of our program is to develop a highly reliable, biocompatible VAD for chronic support (6 months) of the unique and high-risk population of children between 3 kg and 15 kg (patients from birth to 2 years of age). The innovative pediatric VAD we are developing (PediaFlow) is based on a miniature mixed-flow turbodynamic pump featuring magnetic levitation, with the design goal being to assure minimal blood trauma and risk of thrombosis. This article discusses the limitations of current pediatric cardiac assist treatment options and the work to date by our consortium toward the development of a pediatric VAD.
Subject(s)
Heart Failure/surgery , Heart-Assist Devices , Biocompatible Materials/therapeutic use , Child, Preschool , Computer Simulation , Equipment Design , Heart Defects, Congenital/complications , Heart Diseases/complications , Heart Failure/etiology , Humans , Infant , Models, CardiovascularABSTRACT
Motivated by the design of the HeartQuest magnetically levitated left ventricular assist device, closed form expressions have been developed to compute forces and stiffnesses of magnetic suspensions. The theory applies to any combination of concentric permanent magnet rings, and its accuracy and versatility were verified by experiments. The equations adapt to spreadsheet implementation and numerical optimization, providing a powerful tool of optimal design of magnetically levitated ventricular assist devices (VADs). The method was applied to the development of the HeartQuest VAD which achieved remarkable compactness and stable operation.
