Nakazawa T, Takami Y, Makinouchi K, Gay J, Taylor D, Ueyama K, Ohashi Y, Kawahito K, Tayama E, Glueck J, Nosé Y
Department of Surgery, Baylor College of Medicine, Houston, Texas, USA.
Artif Organs. 1997 Jul;21(7):782-5. doi: 10.1111/j.1525-1594.1997.tb03742.x.
The compact eccentric inlet port (C1E3) centrifugal blood pump was developed as a cardiopulmonary bypass (CPB) pump. The C1E3 pump incorporated a sealless design with a blood stagnation free structure. The pump impeller was magnetically coupled to the driver magnet in a sealless manner. To develop an atraumatic and antithrombogenic centrifugal pump without a shaft seal junction, a double pivot bearing system was introduced. Recently, a mass production model of the C1E3 was fabricated and evaluated. The ratio of the normalized index of hemolysis (NIH) of the C1E3 was 0.007 g/ 100 L, in comparison to the NIH of the BP-80, 0.018 g/ 100 L, each in a CPB condition of 5 L/min against 325 mm Hg. Both pumps were compared in identical in vitro circuits. To further evaluate the pumps during cardiopulmonary bypass for reliability and function, 6 h of CPB was performed on each of 8 bovines using either the C1E3 or BP-80 centrifugal pump. The BP-80 and C1E3 provided pump flows of 50-60 ml/kg/min without incident. The hemodynamics were stable, and the hematology and biochemistry data were within normal ranges. There were no statistically significant differences between the 2 groups. Concerning the plasma free hemoglobin values, a mass production model of the C1E3 pump had the same hemolysis levels as the BP-80. Our preliminary studies reveal that the C1E3 pump is reliable. Also, the C1E3 will satisfy clinical requirements as a cardiopulmonary bypass pump.
紧凑型偏心入口端口(C1E3)离心血泵被开发用作体外循环(CPB)泵。C1E3泵采用了无密封设计和无血液停滞结构。泵叶轮以无密封方式与驱动磁体磁耦合。为了开发一种没有轴封连接的无创伤和抗血栓形成的离心泵,引入了双枢轴轴承系统。最近,制造并评估了C1E3的量产型号。在5 L/min对抗325 mmHg的体外循环条件下,C1E3的标准化溶血指数(NIH)为0.007 g/100 L,而BP - 80的NIH为0.018 g/100 L。两种泵在相同的体外循环回路中进行了比较。为了在体外循环期间进一步评估泵的可靠性和功能,使用C1E3或BP - 80离心泵对8头奶牛分别进行了6小时的体外循环。BP - 80和C1E3提供的泵流量为50 - 60 ml/kg/min,无意外情况发生。血流动力学稳定,血液学和生化数据在正常范围内。两组之间无统计学显著差异。关于血浆游离血红蛋白值,C1E3泵的量产型号与BP - 80具有相同的溶血水平。我们的初步研究表明C1E3泵是可靠的。此外,C1E3作为体外循环泵将满足临床需求。