In vitro investigation of the St. Jude Medical Isoflow centrifugal pump: flow visualization and hemolysis studies.

Abstract

Centrifugal blood pumps have become valuable therapeutic tools for cardiopulmonary bypass surgery. In addition, surgeons have used them as temporary ventricular assist devices, and this type of pump is also being developed for use as a permanent assist device and total artificial heart. However, centrifugal pumps create flow patterns that are significantly different from those the blood experiences physiologically. The St. Jude Medical Isoflow centrifugal pump has been used clinically during cardiopulmonary bypass surgery, yet no experimental results have been reported that describe the flow patterns within this pump or that quantify the hemolysis generated over a range of operating conditions. The purpose of this study was to investigate the flow patterns and hemolysis during 4 operating conditions. The experimental operating conditions included the design condition (6 L/min, 2,500 rpm, 350 mm Hg), a high flow condition (10 L/min, 2,500 rpm, 330 mm Hg), a low flow condition (2 L/min, 2,500 rpm, 370 mm Hg), and a near surge condition (2 L/min, 3,000 rpm, 550 mm Hg). The flow visualization results demonstrated that the flow within the impeller was well aligned with the impeller blades except near the inlet at the high flow condition. In contrast, the flow through the outlet was well aligned at the high flow condition while there was evidence of particle impact at the design condition, and the flow was disturbed at the low flow and near surge conditions. The indices of hemolysis (IH) for the 3 operating conditions at 2,500 rpm were 0.0082 +/- 0.0026 (mean +/- SD) for the design condition, 0.0035 +/- 0.0014 for the high flow condition, and 0.0326 +/- 0.0050 for the low flow condition. The indices for high and low flow were significantly different from that for the design condition (p < 0.05). The IH for the near surge condition (0.0748 +/- 0.0039) was significantly higher than that for all other conditions (p < 0.05). In addition to describing the flow patterns within the Isoflow, this study independently validated St. Jude Medical's reported IH at the design condition and showed how that IH significantly changed based on operating conditions.