Magnetic levitation motor for pediatric cardiac and cardiopulmonary therapies - Phase II

点击翻译按钮获取中文摘要

Abstract This Phase II STTR application represents the main research and development effort for an innovative, low cost, magnetic levitation motor specifically designed for neonatal and pediatric extracorporeal cardiac and cardiopulmonary therapies. Our Phase I efforts demonstrated feasibility of a novel magnetic levitation motor enabling contact-free blood pump impeller operation. Contact-free operation eliminates critical areas of wear as well as reduces heat generation that can contribute to hemolysis and thrombosis. The extracorporeal pediatric market is currently served by a single magnetically levitated blood pump (Abbott PediMag). As with many neonatal and pediatric medical products, the PediMag is a scaled-down version of an adult blood pump that was designed for post-cardiotomy support (Abbott CentriMag). While PediMag has been used successfully in a range of post-cardiotomy support applications, broader usage is limited by several factors including lack of ancillary componentry designed specifically for the pump system (e.g., pediatric blood oxygenator and heat exchanger), complex control algorithms, and a high disposable cost (approximately $8000 per disposable PediMag pump head). To address these shortcomings, we developed an innovative and simplified magnetic levitation motor that eliminates the costly rare earth magnetic elements from the disposable blood-contacting component to the reusable motor stator. Our magnetic levitation motor design also permits simplified control algorithms for improved robustness and reduced power requirements. The levitation motor uses the same impeller and pump housing geometry as currently integrated in Ension’s pediatric cardiopulmonary assist system’s (pCAS) pump-oxygenator and replaces the mechanical bearings, rotating shaft, and blood contacting seal. Our strategy to retain the current pCAS pump geometry both lowers overall development costs and permits the use of existing comprehensive in vitro and in vivo test data for performance comparisons. In Phase I, we completed two acute and one 3-day chronic animal study that demonstrated Phase I feasibility and confirmed a Phase II effort is warranted. Goals in Phase II include motor and controller optimization, expansion of a risk-based design history file (DHF) consistent with FDA’s Quality System Regulation (QSR), and conduct of a range of performance testing to establish safety and reliability. Phase III commercialization activities will include a transfer to manufacturing and verification and validation testing to support a regulatory filing to support clinical trials in pediatric patients with cardiac and/or cardiopulmonary dysfunction.