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开发一个直径大的体外流环血栓性测试系统.

Carlos Serna1, Anna Parrish1, Mehulkumar Patel1

  • 1Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.

Artificial organs
|September 2, 2024
PubMed
概括

一个新的9.5毫米内径 (ID) 的体外流循环系统有效地区分医疗器械材料的血栓性. 这种更大的系统,使用动态滚筒阻塞和特定于供体的抗凝剂,有助于开发标准化测试方法.

关键词:
生物材料是一种生物材料.血液流动的循环循环.在体外试验试验封闭设置 封闭设置血小板 血小板 是滚筒 滚筒 滚筒血栓形成的原因是血栓形成.

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科学领域:

  • 生物材料科学 生物材料科学
  • 医疗设备工程 医疗设备工程
  • 血液相容性测试 血液相容性测试

背景情况:

  • 开发了一个更大的体外流循环血栓性测试系统,内径9.5毫米 (ID) 的管道.
  • 该系统扩展了之前建立的6.4毫米ID系统,以适应更广泛的医疗器械尺寸.

研究的目的:

  • 为了评估更大的9.5毫米的ID在体外流循环系统的有效性.
  • 评估其对具有不同血栓生成潜力的材料进行区分的能力.

主要方法:

  • 使用了四个心肺旁路滚筒和一种新的动态滚筒阻塞设置方法.
  • 五种材料 (PTFE,,3D打印尼龙,乳,BUNA) 经过1小时的20转/分钟的肝素化牛血进行了测试.
  • 通过测量血栓表面覆盖面,体重和血小板数量 (PLT) 减少来评估血栓性.

主要成果:

  • 9.5毫米的ID系统成功地将高血栓性材料 (乳,BUNA) 与抗血栓性PTFE区分开来.
  • 和3D打印的尼龙显示中等血栓发生性,血栓形成比乳/BUNA少,但比PTFE多 (p < 0.05).

结论:

  • 9.5毫米的ID测试系统有效地区分了材料的血栓生成潜力,并设置了适当的设置.
  • 该系统是实验室间研究的一部分,旨在标准化医疗器械的体外动态血栓生成性测试.