a Department of Bioengineering and Therapeutic Sciences , University of California , San Francisco , CA , USA.
Expert Rev Med Devices. 2019 Jul;16(7):603-616. doi: 10.1080/17434440.2019.1627199. Epub 2019 Jun 10.
Blood-recirculating medical devices, such as mechanical circulatory support (MCS), extracorporeal membrane oxygenators (ECMO), and hemodialyzers, are commonly used to treat or improve quality of life in patients with cardiac, pulmonary, and renal failure, respectively. As part of their regulatory approval, guidelines for thrombosis evaluation in pre-clinical development have been established. testing evaluates a device's potential to produce thrombosis markers in static and dynamic flow loops.
This review focuses on static and dynamic models to assess thrombosis in blood-recirculating medical devices. A summary of key devices is followed by a review of molecular markers of contact activation. Current thrombosis testing guidance documents, ISO 10993-4, ASTM F-2888, and F-2382 will be discussed, followed by analysis of their application to testing models.
In general, researchers have favored models to thoroughly evaluate thrombosis, limiting evaluation to hemolysis. studies are not standardized and it is often difficult to compare studies on similar devices. As blood-recirculating devices have advanced to include wearable and implantable artificial organs, expanded guidelines standardizing testing are needed to identify the thrombotic potential without excessive use of resources during pre-clinical development.
血液循环医疗设备，如机械循环支持（MCS）、体外膜肺氧合器（ECMO）和血液透析器，分别用于治疗或改善心力衰竭、呼吸衰竭和肾衰竭患者的生活质量。作为其监管批准的一部分，已制定了临床前开发中血栓评估的指南。测试评估设备在静态和动态流路中产生血栓标志物的潜力。
本综述重点介绍了用于评估血液循环医疗设备中血栓形成的静态和动态模型。首先总结了关键设备，然后回顾了接触激活的分子标志物。将讨论当前的血栓测试指导文件 ISO 10993-4、ASTM F-2888 和 F-2382，并分析它们在 测试模型中的应用。
一般来说，研究人员更喜欢 模型来彻底评估血栓形成，将 评估仅限于溶血。 研究没有标准化，通常很难比较类似设备的研究。随着血液循环设备的发展包括可穿戴和植入式人工器官，需要扩大指南来标准化 测试，以在临床前开发过程中识别血栓形成的潜力，而不会过度使用 资源。
