Nakazawa T, Ohara Y, Benkowski R, Makinouchi K, Takami Y, Ohtsubo S, Kawahito K, Tasai K, Glueck J, Noon G P, Sueoka A, Schmallegger H, Schima H, Wolner E, Nosé Y
Department of Surgery, Baylor College of Medicine, Houston, Texas, USA.
Int J Artif Organs. 1997 Apr;20(4):222-8.
A pivot bearing-supported centrifugal blood pump has been developed. It is a compact, cost effective, and anti-thrombogenic pump with anatomical compatibility. A preliminary evaluation of five paracorporeal left ventricular assist studies were performed on pre-conditioned bovine (70-100 kg), without cardiopulmonary bypass and aortic cross-clamping. The inflow cannula was inserted into the left ventricle (LV) through the apex and the outflow cannula affixed with a Dacron vascular graft was anastomosed to the descending aorta. All pumps demonstrated trouble free performance over a two-week screening period. Among these five studies, three implantations were subjected for one month system validation studies. All the devices were trouble free for longer than 1 month. (35, 34, and 31 days). After achieving one month studies, all experiments were terminated. There was no evidence of device induced thrombus formation inside the pump. The plasma free hemoglobin levels were within normal ranges throughout all experiments. As a consequence of these studies, a mass production model C1E3 of this pump was fabricated as a short-term assist pump. This pump has a Normalized Index of Hemolysis of 0.0007 mg/100L and the estimated wear life of the impeller bearings is longer than 8 years. The C1E3 will meet the clinical requirements as a cardiopulmonary bypass pump. For the next step, a miniaturized pivot bearing centrifugal blood pump P1-601 has been developed for use as a permanently implantable device after design optimization. The evolution from C1E3 to the PI-601 converts this pivot bearing centrifugal pump as a totally implantable centrifugal pump. A pivot bearing centrifugal pump will become an ideal assist pump for the patients with failing heart.
一种枢轴轴承支撑的离心式血泵已被研发出来。它是一种紧凑、经济高效且具有抗血栓形成能力且与人体解剖结构相兼容的泵。在未进行体外循环和主动脉交叉钳夹的情况下，对经过预处理的70 - 100千克牛进行了五项体外左心室辅助研究的初步评估。流入插管通过心尖插入左心室，流出插管与涤纶血管移植物固定后吻合至降主动脉。在为期两周的筛查期内，所有泵均表现出无故障运行。在这五项研究中，有三项植入进行了为期一个月的系统验证研究。所有装置在超过1个月（35天、34天和31天）的时间内均无故障。在完成一个月的研究后，所有实验均终止。没有证据表明泵内有装置诱导的血栓形成。在所有实验过程中，血浆游离血红蛋白水平均在正常范围内。基于这些研究结果，制造了该泵的量产型号C1E3作为短期辅助泵。该泵的溶血标准化指数为0.0007毫克/100升，叶轮轴承的估计磨损寿命超过8年。C1E3将满足作为体外循环泵的临床需求。下一步，在设计优化后，已研发出一种小型枢轴轴承离心式血泵P1 - 601，用作永久植入式装置。从C1E3到PI - 601的演进将这种枢轴轴承离心泵转变为完全植入式离心泵。枢轴轴承离心泵将成为心力衰竭患者的理想辅助泵。
