The purpose of this work is to design, fabricate, evaluate and manufacture an innovative disposable Pump Chamber for the standard extracorporeal roller pump that is used in many artificial organ circuits. The proposed pump self-regulates the inlet and outlet pressure independent of the flow rate. Current roller pumps tend to maintain constant flow independent of changes in inlet or outlet pressures that can """"""""blow"""""""" parts of the outlet circuit. Bench tests, in-vitro and in-vivo studies comparing the flow regulation and blood damage of the Pump Chamber to standard tubing will be followed by 510k application and clinical trials. Successful tests of Phase I prototypes have lead four major medical centers to express interest in conducting clinical trials for one or more of the following applications: short term cardiopulmonary bypass for arterial pumping; left or right ventricular venting; coronary suction; long term pumping for extracorporeal membrane oxygenator (ECMO) or left and/or right heart bypass. The Pump Chamber could provide the advantages of centrifugal pumps at a fraction of the cost.
