A Novel Pediatric Pulsatile Rotary Ventricular Pump

DESCRIPTION (provided by applicant): A novel, pulsatile, disposable pump (pediatric MPulse) 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 MPulse presents a new option for pediatric extended cardiac support. The pediatric MPulse 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 objectives have been met. An MPulse pump chamber geometry has been defined and shown to produce target pulsatility above that of current technology over a range of flow conditions representative of pediatric CPB. Performance targets for durability and hemolysis were met. Phase II research will concentrate on refinement of chamber design for improved blood handling and optimization for robust manufacturing processes. Necessary electronic hardware and software will be developed to support animal studies which will be conducted to demonstrate effectiveness and safety in a clinical setting. All device design, manufacturing process optimization and testing activities will be conducted and documented under design controls to facilitate transfer to a manufacturing partner per our Phase III commercialization plans. PUBLIC HEALTH RELEVANCE: 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.