A Bearingless, Fail-safe, High Performance Pump for "Failing Fontan" Patients

About This Grant

Project Summary/Abstract This proposal addresses the development of mechanical circulatory support devices for individuals with congenital heart disease and single ventricle physiology after Fontan surgical palliation. The design was specifically stimulated by the requirements and design suggestions outlined to Perfusion Solutions, Inc. (PSI) by pediatric and congenital surgeon Dr. Pranava Sinha. The surgical treatment and management has dramatically advanced since the early days of development of surgical treatment of single ventricle heart disease. Patients now routinely survive into their teen and early adult years. However, significant morbidities develop, ranging from minimal exercise capability through terminal heart, liver and kidney pathologies. These are a product of diastolic heart dysfunction, and are not universally relieved with systemic assistance. There is a need for a long term cavopulmonary assist system which can bridge patients over the often very long wait for a donor heart or potentially serve as a destination therapy. A suitable device will provide flows and pressures for the superior and inferior vena cavae (defined as flows of nominally 3.0-6.0 lpm, pressure rises normally between 5 and 15 mmHg but possibly higher with hypertension, blood compatibility in the venous circulation, and have minimal resistance to forward flow should pump rotation be interrupted. The rotor is supported by a special “bearingless” motor. The motor/bearing rotor is integrated into the pump rotor, while its stator is part of the pump stator. During the phase I research, the bearingless motor will be designed and developed, and the hydraulic configuration will be reviewed for any impacts from integration of the new drive and suspension design. Satisfaction of the success criteria will be shown, specifically, obtaining the defined hydraulic performance, minimal hemolysis, low static pressure drop, acceptable power consumption and stable suspension. During Phase II, clinical prototypes will be built and evaluated in depth, including in vivo studies. PSI was incorporated in 2008 to commercialize the technology developed by Dr. William Smith during his career at the Cleveland Clinic; in 2012, after 30 Cleveland Clinic years, he retired and joined PSI full time. PSI has partnered for several years with Dr. Pranava Sinha of the University of Minnesota (UMN) to use PSI’s PediPump as part of Dr. Sinha’s Fontan support research program. Dr. Sinha will continue as the medical design consultant for this new program and lead the future in vivo program. Dr. Eric Severson, a bearingless motor design expert and also a UMN faculty member will serve as the STTR’s PI to lead the critical new design work.