Pulsatile Pediatric Blood Pump Development

A widely recognized problem in pediatric cardiac surgery is the lack of suitable mechanicalcirculatory support devices. In this Phase I program, rotary pump technology will be utilized for a bloodpump system specifically intended for neonatal/pediatric (N/P) use. This device incorporates a miniatureextracorporeal centrifugal pump that generates pulsatile flow. This is accomplished by programming thepump's electronic controller to modulate rotating speed; no flow valves or any other mechanical devicesare required. Starting with a miniature centrifugal pump system recently developed by us, the initialfocus of Phase I will be to design and fabricate the N/P pumps, as well as the pulsatile flow controllers.Next, using bench tests, the system/controller will be flow tested to define controller parameters relativeto N/P pulsatile flow characteristics. The effect of pulsatile flow on hemolysis will be determined by invitro tests. And, the impact of pulsatile flow on the integrity of the pump's shaft seal will be measuredthrough in vitro testing. Three acute in vivo studies will be performed at the Univ. of Pittsburgh todemonstrate basic hemodynamic performance and biocompatability, and assess the suitability of thepulsatile system for N/P applications.