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一种用于医用管材的新型体外血栓形成性测试。

A new in vitro thrombogenicity test for medical tubes.

作者信息

Lemm W

机构信息

Department of Experimental Surgery, Rudolf Virchow Clinic, Charlottenburg, Berlin, FRG.

出版信息

J Biomater Sci Polym Ed. 1991;2(1):15-23. doi: 10.1163/156856291x00025.

Abstract

Basic information on the affected coagulation behaviour of healthy human blood passing foreign artificial surfaces is of immense importance for a safe clinical therapy. An in vitro screening method is presented which tests the thrombogenicity of medical tubes, applying the clinically already established resonance thrombography (RTG). Several medical tubes with various types and contents of plasticizers are tested and compared with materials free of additives. The effect of the release of ingredients is indicated by this procedures, as well as the influence of a sterilizing treatment with gamma-radiation on the physical surface properties, such as smoothness. In all cases, the modified RTG method proves its suitability and sensitivity. In addition, this method allows accurate adjustment of the extrusion parameters for tube manufacturers.

摘要

了解健康人体血液接触外来人工表面时凝血行为的基本信息对于安全的临床治疗至关重要。本文介绍了一种体外筛选方法,该方法采用临床已确立的共振血栓形成法(RTG)来测试医用管材的血栓形成性。对几种含有不同类型和含量增塑剂的医用管材进行了测试,并与无添加剂的材料进行了比较。该程序表明了成分释放的影响,以及γ射线灭菌处理对物理表面特性(如光滑度)的影响。在所有情况下,改进后的RTG方法都证明了其适用性和敏感性。此外,该方法还能让管材制造商精确调整挤出参数。

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