中国组织工程研究

中国组织工程研究 ›› 2012, Vol. 16 ›› Issue (21): 3886-3890.doi: 10.3969/j.issn.1673-8225.2012.21.020

• 材料生物相容性 material biocompatibility • 上一篇    下一篇

磁悬浮离心式心室辅助装置的体外溶血测试**★

吴广辉1，蔺嫦燕1，陈  琛2，杨  鹏2，渠文波2，姚凌飞2，王  璟1   

  1. 1首都医科大学附属北京安贞医  院－北京心肺血管疾病研究所，北京市  100029；   2苏州同心医疗器械有限公司，江苏省苏州市   215125；3首都医科大学附属北京安贞医院，北京市   100029
  • 收稿日期:2011-12-07 修回日期:2012-01-12 出版日期:2012-05-20 发布日期:2012-05-20
  • 通讯作者: 蔺嫦燕，博士，教授，首都医科大学附属北京安贞医 院－北京心肺血管疾病研究所，北京市 100029 assosiate@sina.com
  • 作者简介:吴广辉★，男，1978年生，山西省大同市人，汉族，2005年北京心肺血管疾病研究所毕业，硕士，助理研究员，主要从事生物医学工程方面的研究。assosiate@ sina.com
  • 基金资助:

    国家高技术研究发展计划项目(863计划，2009AA045401)；北京市自然基金资助项目(3112011)。

In vitro hemolysis test of a maglev centrifugal ventricular assist device

Wu Guang-hui1, Lin Chang-yan1, Chen Chen2, Yang Peng2, Qu Wen-bo2, Yao Ling-fei2, Wang Jing1   

  1. 1Beijing Institute of Heart Lung and Blood Vessel Diseases, Beijing Anzhen Hospital, Capital Medical University, Beijing  100029, China; 2China Heart Biomedical Incorporation, Suzhou  215125, Jiangsu Province, China; 3Beijing Anzhen Hospital, Capital Medical University, Beijing  100029, China
  • Received:2011-12-07 Revised:2012-01-12 Online:2012-05-20 Published:2012-05-20
  • Contact: Lin Chang-Yan, Doctor, Professor, Beijing Institute of Heart Lung and Blood Vessel Diseases, Beijing Anzhen Hospital, Capital Medical University, Beijing 100029, China assosiate@sina.com
  • About author:Wu Guang-hui★, Master, Assistant researcher, Beijing Institute of Heart Lung and Blood Vessel Diseases, Beijing Anzhen Hospital, Capital Medical University, Beijing 100029, China assosiate@sina.com
  • Supported by:

    National High Technology Research and Development Program of China (863 Program), No. 2009AA045401*; the Natural Science Foundation of Beijing, No. 3112011*

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摘要：

背景：心室辅助装置已广泛应用于心力衰竭患者的治疗。虽然有不同的血泵在国外应用于临床，却很少在国内应用，主要原因是其价格太高。因此在国内研制相对价格较低的能应用于临床的自主血泵迫在眉睫。
目的：测试置入式磁悬浮离心心室辅助装置主体血泵的溶血性能。
方法：通过计算流体力学方法，对磁悬浮离心式心室辅助装置主体血泵内部流场做初步分析。血泵在后负荷100 mm Hg     (1 mm Hg=0.133 kPa)、流量5 L/min 情况下，通过体外模拟血循环系统驱动羊血测试血泵体外溶血性能，计算血泵实际标准溶血指数NIH。
结果与结论：在设计工况下计算流体力学结果显示血泵内部流线平稳，整个流道内部壁面剪切力均在68.5 Pa以下，内部静压力分布均匀，过渡平稳，没有不良区域出现。体外溶血实验测得标准溶血指数NIH值为(0.075±0.017) mg/L。提示血泵驱动叶片及内部流道设计合理，同第3代血泵相比有较好溶血性能。血泵实验期间无不良状况发生，可以进行下一步长期的动物体内实验，进而评估血泵体内血流动力学性能和血泵置入对实验动物脏器的影响。

关键词: 离心血泵, 心室辅助装置, 磁悬浮, 溶血实验, 计算流体力学

Abstract:

BACKGROUND: Ventricular assist devices are widely used in patients with heart failure. Although different blood pumps have been developed and used throughout the world, few blood pumps are used in China because of the high prices. Development of a less expensive pump for clinical use is urgently needed in China.
OBJECTIVE: To test the hemolytic characteristics of an implantable magnetic suspension centrifugal ventricular assist device       in vitro.
METHODS: The flow field of the blood pump was analyzed with the computational fluid dynamics. Blood pumps were connected in a mock circulatory loop, filled with fresh sheep blood, and the pump generated 5 L/min flow against a head pressure of 100 mm Hg (1 mm Hg=0.133 kPa). The in vitro hemolytic properties were evaluated by determining the level of plasma free hemoglobin at defined intervals.
RESULTS AND CONCLUSION: Based on the computational fluid dynamics, a stable blood flow line was shown inside the pump, the wall shear stress inside the pump was less than 68.5 Pa and the internal static pressure distribution was smooth without adverse area. The normalized index of hemolysis was (0.075±0.017) mg/L. The blood pump showed satisfactory hemolytic properties as compared with the other third generation pumps. No mechanical failure occurred during the experiments. Therefore, long-term in vivo circulation assist experiment of the new blood pump could be carried on to evaluate its hemodynamics and end-organ effect in the future.

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