A Novel Pediatric Pulsatile Rotary Ventricular Pump

Period of Performance: 02/15/2008 - 02/14/2009


Phase 1 SBIR

Recipient Firm

Mc3, Inc.
DEXTER, MI 48130
Principal Investigator


DESCRIPTION (provided by applicant): A novel Pediatric Pulsatile Rotary Ventricular (PRVP) pump will be researched for pediatric Cardiopulmonary Bypass surgery which offers physiologic pulsatile blood flow, inherently safe management of low extracorporeal volumes, highly accurate very low flow control, and extended durability for long term cardiopulmonary support. These features address ongoing morbidity concerns due to vital organ injury in pediatric CPB patients caused by non-physiologic blood flows, excessive hemodilution, poor cerebral blood flow, and acute injury due to equipment failure and operator error. In addition, the pediatric PRVP presents a new option for pediatric extended cardiac support. The RPVP uses a passively filled compliant pumping chamber and operates under Starling principles, like the natural heart. The compliant pump chamber passively fills, and the pump produces a discharge flow based on the volume of fluid that is provided. A physiologic pulsatile flow is created under constant RPM conditions through a novel lengthwise variation of the pumping chamber geometry. Inherent safety advantages prevent retrograde flow, maintain safe circuit pressures, and prevent inadvertent draining of the venous reservoir. Phase I research will concentrate on designing the novel pump chamber, and validating safety and hydraulic performance on a pediatric mock loop. Computer modeling will be conducted to develop a hydraulic mock loop to simulate a one year old patient model as reported in the literature. The hydraulic mock loop will be manufactured and validated on the bench. The pump design will be tuned through iterative prototyping to generate a physiologic pulsatile flow and pressure in the patient mock loop while operating in a CPB extracorporeal loop configuration. Comparative testing will be conducted in the hydraulic circuit with a standard pulsatile roller pump over a range of flow conditions representative of pediatric CPB and post operative ventricular support. The PRVP design will be bench tested for verification of performance relative to durability and hemolysis. Phase II activities will focus on fabricating preproduction prototypes and conducting animal studies to verify device performance.This grant will result in the development of a novel pediatric blood pump for pediatric Cardiopulmonary Bypass surgery with extended durability to allow for long term cardiac support following surgery. Currently, no pump system of this type exists for pediatric patients so physicians have limited options when cardiac support post surgery is necessary.