北京生物医学工程

叶轮式连续型血泵血栓评价方法及关键因素分析

Evaluation methods and key factors of impeller blood pump thrombosis

作者：张文静程云章叶葳唐洁

单位：上海理工大学上海介入医疗器械工程技术研究中心（上海 200093）丰凯医疗器械（上海）有限公司（上海 201138）

关键词：心力衰竭；叶轮式连续型血泵；血栓形成；血栓评价

分类号：R318.6

出版年·卷·期（页码）：2019·38·5（523-529）

摘要：

血栓的产生会影响血泵运转，同时也可能给患者带来栓塞或中风等不良并发症。新一代叶轮式连续型血泵体积小、各部件之间间隙小，这些特点使其更易形成血栓，从而导致设备功能障碍。因此血栓评价对考察叶轮式连续型血泵的安全性和有效性具有重要意义。本文从血泵运转中血栓形成的过程及血栓的种类入手，首先对比了研发过程中血栓评价的三种方法，即数值模拟、体外试验、体内试验，分析发现体内试验评价血栓更具有说服力。然后从血泵设计、材料选择及加工、抗凝三大主要因素分析对血栓形成的影响：血泵的设计决定血液流场分布，材料的选择及加工影响其抗凝血程度，抗凝不足或过度也将产生不良影响。最后对叶轮式连续型血泵血栓评价方法进行了总结和展望。

Thrombosis can affect the operation of the blood pump and cause embolism or strokes and other adverse complications. The new generation of impeller continuous blood pumps have smaller sizes and smaller gaps between different parts of the pump. These characteristics make the blood pumps more likely to form thrombosis, resulting in equipment dysfunction. Therefore, thrombosis evaluation is of great significance to the safety and effectiveness of blood pumps. This article starts with the process of thrombosis and types of thrombosis, analyzs and compares three methods of thrombosis evaluation in the research: numerical simulation, vitro test and vivo test. The result finds vivo test is more convinced. Then the article analyzes three major factors on thrombosis, including blood pump design, material selection and processing, anticoagulation: the design of blood pump determines flow field distribution, material selection and processing affects its antithrombotic property, insufficient or excessive anticoagulation has adverse effects. Finally, the evaluation methods of impeller continuous blood pump thrombosis are summarized and prospected.

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