国产可植入式自悬浮心室辅助装置的体外实验

The hemolysis research and fatigue test in vitro of the national implantable ventricular assist device

目的 对国产可植入式自悬浮心室辅助装置(national implantable ventricular assist device,NIVAD)进行体外实验研究,评价溶血性能和耐疲劳稳定性.方法 将NIVAD安置于自行设计的体外测试平台中,充满新鲜抗凝猪血2 500 ml,设定血泵转速8 000转/min,后负荷100 mmHg(1 mmHg=0.133 kPa),流量3.5 L/min,恒温37℃,转泵前、后多个时间点取血样本测量游离血红蛋白(FHB),同时留置静置血液为对照组,分别计算血泵标准化溶血指数(NIH).疲劳实验将血液换为纯净水,条件不变,连续记录90天泵的各项参数.结果 与对照组相比,实验组FHB增高,NIVAD的NIH值为(0.0052±0.0019) mg/L.疲劳实验中血泵连续正常运转90天,运行平稳,各项参数稳定.结论 NIVAD血泵对血液有一定的破坏,但在允许范围之内,与国内外同类产品相比,具有一定优势,同时有较好的耐疲劳能力.

Objective To evaluate the hemolysis and fatigue resistance self suspension ventricular assist device (NIVAD) in vitro.Methods Resettled NIVAD which is filled with 2 500 ml fresh anticoagulant blood from pig in vitro loop system.The speed of blood pump was adjusted to 8 000 rpm.The afterload and the flow of pump were set as 100 mmHg and 3.5 L/min respectively.Keep the temperature at around 37 degree centigrade which is equal to average internal temperature in pig.Then harvest and measure the free hemoglobin(FHB) of blood samples at different time points before and after working.Then calculated the normalized index of hemoylsis(NIH) by comparing to control group, the unused pig blood at the same period.In fatigue test, conditions remained unchanged, except the blood was replaced by pure water.The blood pump had operated for 90 d continuously and recorded its performance.Results The FHB of experimental blood is higher than that of the control.The normal index of hemolysis NIVAD is(0.0052 ±0.0019)mg/L.Fatigue test , the blood pump operated smoothly, and every parameters was stable.Conclusion The blood pump of NIVAD does a certain degree of destruction to blood, but the NIH is in criterion range of hemolysis, it has certain advantages compared to similar products in china and aboard.At the same time it has good resistance and stable property to fatigue.