A small, intravascular catheter pump providing adequate output, good blood compatibility, and high reliability is being designed for use as a cardiac-assist pump in the operating room or interventional cardiology laboratory. This pump would function not only for minimally invasive surgery, but also as a valuable, intermediate level of support between balloon pumps and the much more invasive cardiopulmonary bypass or ventricle-assist devices. Compared to existing catheter pumps, the proposed design is unique in its use of magnetic bearings, and, thus, avoids mechanical bearings or seals that could cause thrombosis. Further, since blood flows through the motor gap, as well as over the outside diameter, the motor is well-cooled, allowing for the compactness of the design and the mechanical durability (i.e., high reliability) of the pump over extended periods. The Phase I pump is 7 mm in diameter, and designed to produce 3 I/min at 90 mm Hg when running at approximately 30,000 rpm. During Phase I, test data will be used to optimize the design at or below 6-mm outside diameter to enhance the pump's potential for peripheral, as well as central, insertion in the aorta. During Phase II, a production prototype will be designed, bench-tested, and in-vivo tested.
The market for the proposed catheter pump evolves from the cardiac, minimally invasive surgery field, which is estimated to include over 30,000 cases in 2000, and is still be growing rapidly. The pump will also be a more hemodynamically potent cardiac-assist device than balloon pump, which are predicted to have sales of nearly 90,000 units in 2000.
