In vitro and in vivo testing of a new valved intravascular catheter design

Long-term intravascular catheterization carries a finite risk of catheter occlusion. A catheter tip valve design is presented (Buchwald-Wigness, Strato Medical Corporation, Beverly, MA) which incorporates features designed to decrease the risk of thromboembolism and reduce the need for maintenance procedures. Aspiration and infusion are controlled by separate valves, making it possible to engineer optimized inlet and outlet parameters. The outlet valve is an elastic sleeve expanded around the sidewall outlet ports which opens under injection pressure. The inlet valve is a tubular elastic element compressed against the inlet port from within the lumen, opening under aspiration pressure. A series of valves were prototyped with outlet pressures ranging from 2 to 100" H2O, and inlet pressures ranging from -40-70" H2O, and flowrates at 36" H2O of greater than 1,400 ml/hr. Dog implants of two prototypes with outlet valve pressures of 10" H2O, and inlet pressures of -40" H2O, demonstrated that dormant periods of up to 7.5 weeks could be achieved without detectable blood cell entry into the lumen. No significant hemolysis was observed in blood samples aspirated with a 6 cc syringe (8% scored "slightly hemolyzed" vs. 44% with the nonvalved controls) indicating that a hemodialysis application is likely.