Magnetic levitation motor for pediatric cardiac and cardiopulmonary therapies

Period of Performance: 08/15/2016 - 07/31/2017

$357K

Phase 1 STTR

Recipient Firm

Ension, Inc.
Pittsburgh, PA 15238
Principal Investigator
Principal Investigator

Abstract

AbstractThis Phase I STTR application proposes development of an innovative, low cost, magnetic levitation motorspecifically designed for pediatric extracorporeal cardiac and cardiopulmonary therapies. Magnetic levitationenables contact-free impeller operation thereby eliminating critical areas of wear and heat generation that cancontribute to hemolysis and thrombosis. The extracorporeal pediatric market is currently served by a singlemagnetically levitated blood pump (St. Jude Medical's PediMag (formerly Thoratec)). As with many pediatricmedical products, the PediMag is a scaled-down version of a prior adult device originally designed for post-cardiotomy support (CentriMag). While PediMag has been used successfully in a range of post-cardiotomysupport applications, broader usage is complicated by several factors including lack of ancillary componentrydesigned specifically for the pump system (e.g., pediatric blood oxygenator and heat exchanger), complexcontrol algorithms, and a high disposable cost (approximately $8000 per disposable PediMag pump head). Toaddress these shortcomings, we propose an innovative magnetic levitation system based on a hysteresismotor concept that permits a smaller overall configuration, eliminates magnetic field safety concerns, reducesvibration, and relocates the costly rare earth magnetic elements from the disposable blood-contactingcomponent to the reusable motor stator. The hysteresis motor design also permits simplified controlalgorithms for enhanced robustness and reduced power requirements enhancing patient transport andmobility. The rotor/impeller portion of the proposed hysteresis motor will be based on the same impellergeometry as is currently used in the existing pCAS pump-oxygenator replacing the current mechanicalbearings, rotating shaft, and blood contacting seal. This strategy will lower overall development costs andpermit the use of existing comprehensive in vitro and in vivo test data to allow direct and efficient comparisonof the performance of the new magnetically levitated prototype to the existing blood seal-based pCAS pump-oxygenator. In Phase I, we will perform two acute and one 3-day chronic animal study. This permits us todemonstrate basic feasibility while simultaneously minimizing costs and the Phase I project timeline. However,as part of a subsequent Phase II effort we plan to significantly expand our chronic in vivo studies to includemultiple evaluations of at least 30 days.!