ChinaHeart心室辅助装置溶血性能研究  

Study of Hemolysis Performance for ChinaHeart Ventricular Assist Device

作　　者：徐创业[1,2] 蔺嫦燕[1,2] 吴广辉[1,2] 刘修健[1,2] 杨朋 渠文波 

机构地区：[1]首都医科大学附属北京安贞医院,北京100029 [2]北京市心肺血管疾病研究所,北京100029 [3]苏州同心医疗器械有限公司,江苏苏州215125

出　　处：《中国医疗设备》2012年第11期46-49,共4页China Medical Devices

基　　金：国家863计划项目(2012AA041605);北京市自然基金项目(2010311)

摘　　要：目的心室辅助装置在治疗心力衰竭过程中会对红细胞造成破坏,本文欲在ChinaHeart VAD用于临床前测试其血泵的溶血性能,检验其血液相容性。方法血泵的溶血性能测试包括体外实验和在体实验。体外溶血测试中,将血泵连接至体外模拟循环试验台,调节血泵转速和阻尼阀使输出流量为(5.0±0.25)L/min,平均压力为(100±3)mmHg,驱动抗凝后新鲜羊血,分别在泵转动前(0 min)、泵转动后60 min、120 min、180 min、240 min时检测血浆游离血红蛋白(PlasmaFree Hemoglobin,FHB)含量和红细胞压积(Hct),计算血泵标准溶血指数(Normalized Index ofHemolysis,NIH)。在体溶血测试中,取2只健康雄性小尾寒羊,麻醉后将血泵植入心尖,建立由左心室经心室辅助装置到降主动脉辅助循环旁路,控制血泵辅助流量占总心输出量的60%左右,进行在体辅助试验,定期抽血检测血浆FHB含量和Hct值。将体外和在体实验结果同国内外典型血泵比较,横向评测ChinaHeart VAD血泵溶血特性。结果体外溶血实验中,血泵运行平稳,温度正常,无卡壳、漏液等状况。测得血泵体外NIH值为(0.0076±0.0016)g/100L。在体溶血实验中,2只羊分别成功辅助20天和38天,无明显肝肾功能障碍。FHB含量开始数天内呈上升趋势,分别达到最大值0.0846 g/L(存活20天)和1.0957g/L(存活38天),之后逐渐下降到术前水平。结论 ChinaHeart VAD血泵具有良好的体外和在体溶血性能,可以进行动物在体辅助长期存活实验。Objective As ventricular assist device（VAD） may bring about damage to red blood cell（RBC） in treating heart failure, this paper attempts to test the hemolytic performance of ChinaHeart VAD blood pump before clinical application. Methods The hemolytic performance test includes vitro test and vivo test. In vitro test, we connected the blood pump with a simulative circulation test bed, adjusted its speed and orifice valve to make the outflow （5±0.25） L/min,.the average pressure （100±3） mmHg, drove fresh goat blood after being anti-freezed, detected plasma free bemoglobin（FHB） and hematokrit（Hct） before pumping and at every hour of pumping for 4 hours, and then calculated the normalized index of hemolysis （NIH）. In vivo test, we took 2 healthy male small tail ban sheep, implanted blood pump into heart apex after anesthesia, and set up a auxiliary cycle bypass from the left ventricular through VAD to descending aorta, controlled blood pump auxiliary flow accounting for 60% of the total cardiac output, thgn proceeded the auxiliary vivo test, regularly drew blood to detect FHB and Hct, finally, compared the results of the two test with typical blood pumps at home and abroad to evaluate the hemolytic characteristics of ChinaHeart VAD crosswise. Results In vitro test, the blood pump runned smoothly, had normal temperature, no leakage and no block. The NIH of blood pump in vitro is （0.0076±0.0016）g/100L. In vivo test, 2 sheep had been successfiully assisted for 20 and 38 days respectively ,with no obvious renal and hepatic dysfunction. The FHB content showed a rising trend, with the maximum value of 0.0864g/L （20 days） and 1.0957g/L （38 days）, and then decreased to the preoperative levels gradually. Conclusion ChinaHeart VAD blood pump has favorable hemolytic performance in vitro and in vivo, and can perform long-term survival experiment of animals in vivo test.

关 键 词：心室辅助装置 血泵 溶血性能 标准溶血指数 

分 类 号：R318[医药卫生—生物医学工程]