Hong Jun Ki, Gao Lingzi, Singh Jasneil, Goh Tiffany, Ruhoff Alexander M, Neto Chiara, Waterhouse Anna
School of Chemistry, The University of Sydney, NSW 2006, Australia.
Biomater Sci. 2020 Nov 7;8(21):5824-5845. doi: 10.1039/d0bm01284j. Epub 2020 Oct 12.
Although blood-contacting medical devices are used widely, blood clot formation (thrombosis) leads to device failure and potentially catastrophic adverse thrombotic events for patients, such as stroke or pulomonary embolism. Systemic anti-thrombotic drugs aimed at reducing these complications do not always prevent device thrombosis and can cause increased bleeding risks. Therefore, our understanding of material thrombosis mechanisms needs to be improved in order to develop next generation blood-contacting medical devices and materials. Medical device development requires material thrombogenicity evaluation according to the International Standards 10993-4 Biological evaluation of medical devices-Selection of tests for interactions with blood, which highlights that one of the key aspects for testing is a clinically relevant flow system. In this review, we first provide an overview of the current knowledge regarding material thrombosis and important physical and biological aspects of blood flow in relation to thrombus formation. We then examine commonly used in vitro flow systems to evaluate material and medical device thrombosis, focusing on their capabilities, advantages and disadvantages. Finally, we explore recent advances in technology that will aid in improving the design and fabrication of flow systems, mechanistic analysis and computational modelling.
尽管与血液接触的医疗设备被广泛使用，但血栓形成会导致设备故障，并可能给患者带来灾难性的不良血栓事件，如中风或肺栓塞。旨在减少这些并发症的全身性抗血栓药物并不总能预防设备血栓形成，还可能增加出血风险。因此，为了开发下一代与血液接触的医疗设备和材料，我们需要提高对材料血栓形成机制的理解。医疗设备的开发需要根据国际标准10993-4《医疗器械生物学评价——与血液相互作用试验的选择》对材料的血栓形成倾向进行评估，该标准强调测试的关键方面之一是具有临床相关性的流动系统。在这篇综述中，我们首先概述了目前关于材料血栓形成的知识以及与血栓形成相关的血流的重要物理和生物学方面。然后，我们研究了常用的体外流动系统，以评估材料和医疗设备的血栓形成情况，重点关注它们的能力、优点和缺点。最后，我们探讨了有助于改进流动系统设计和制造、机理分析和计算建模的技术最新进展。
