Tayama E, Ohtsubo S, Nakazawa T, Takami Y, Niimi Y, Makinouchi K, Glueck J, Nosé Y
Department of Surgery, Baylor College of Medicine, Houston, Texas 77030, USA.
Artif Organs. 1997 May;21(5):418-20.
One of the major considerations in the development of a circulatory assist device is its antithrombogenecity. Although the precise evaluation should be accomplished by in vivo tests, these tests are costly and require a relatively long period. In this study, we established a simple in vitro test and assessed feasibility using 2 clinically available centrifugal pumps, the BioMedicus and Nikkiso pumps. Two identical mock loops were fabricated, and fresh heparinized human blood (activated clotting time of 150-250 s) was circulated at 5 L/min against a total pressure head of 100 mm Hg. After 3 h of pumping, only the BioMedicus pumps had thrombi while the Nikkiso pumps were thrombus free. Following 6 h of pumping, thrombi were observed in both pumps. Clotting patterns and locations were reproducible in each pump and similar to the results of clinical or ex vivo studies. This simple in vitro test was considered to be feasible as a pilot study, particularly to predict thrombogenic sites.
循环辅助装置研发中的一个主要考量因素是其抗血栓形成性。尽管精确评估应由体内试验完成，但这些试验成本高昂且需要较长时间。在本研究中，我们建立了一种简单的体外试验，并使用两种临床可用的离心泵——百特医疗（BioMedicus）泵和日机装（Nikkiso）泵评估其可行性。制作了两个相同的模拟回路，新鲜肝素化人血（活化凝血时间为150 - 250秒）以5升/分钟的流速循环，对抗100毫米汞柱的总压头。泵送3小时后，只有百特医疗泵形成了血栓，而日机装泵没有血栓。泵送6小时后，两个泵都观察到了血栓。每个泵中的凝血模式和位置都是可重复的，并且与临床或体外研究结果相似。这种简单的体外试验被认为作为初步研究是可行的，特别是用于预测血栓形成部位。
