Abstract：
BACKGROUND: Ischemic stroke is a leading cause of death and significant long-term disability worldwide. Mechanical thrombectomy is emerging as a standard treatment for eligible patients. As clinical implementation of stent retrieval and aspiration thrombectomy increases, there is a need for physiologically relevant in vitro device efficacy testing. Critical to this testing is the development of standardized \'soft\' and \'hard\' synthetic blood clots that mimic the properties of human thrombi and are compatible with imaging technologies. Synthetic clots allow researchers to extract information regarding clot integration, model hemodynamics, and quantify the physics of thrombectomy.
METHODS: This work develops polyacrylamide and alginate-based synthetic clots that are compatible with particle image velocimetry (PIV) and radiographic imaging techniques while maintaining mechanical properties of \'soft\' and \'hard\' human clots. Dynamic mechanical analysis testing using an HR2-Rheometer demonstrates comparable mechanical properties to human clots previously tested by this research group and provided in existing literature.
RESULTS: The synthetic clots are formulated with either 0.5% w/v polyethylene microspheres for PIV visualization or 20% w/v barium sulfate for angiographic visualization, enabling real-time imaging of clot behavior during thrombectomy simulations. The soft formulation shows compressive and shear properties of ~12 kPa and 2-3 kPa, respectively. The hard clots are 3-4 times stiffer, with compressive and shear properties of 41-42 kPa and 8-9 kPa, respectively.
CONCLUSIONS: Standardized synthetic clots offer a platform for reproducible device testing. This provides a greater understanding of mechanical thrombectomy device efficacy, which may lead to quantifiable advances in device development and eventual improved clinical outcomes.
METHODS: This work develops polyacrylamide and alginate-based synthetic clots that are compatible with particle image velocimetry (PIV) and radiographic imaging techniques while maintaining mechanical properties of \'soft\' and \'hard\' human clots. Dynamic mechanical analysis testing using an HR2-Rheometer demonstrates comparable mechanical properties to human clots previously tested by this research group and provided in existing literature.
RESULTS: The synthetic clots are formulated with either 0.5% w/v polyethylene microspheres for PIV visualization or 20% w/v barium sulfate for angiographic visualization, enabling real-time imaging of clot behavior during thrombectomy simulations. The soft formulation shows compressive and shear properties of ~12 kPa and 2-3 kPa, respectively. The hard clots are 3-4 times stiffer, with compressive and shear properties of 41-42 kPa and 8-9 kPa, respectively.
CONCLUSIONS: Standardized synthetic clots offer a platform for reproducible device testing. This provides a greater understanding of mechanical thrombectomy device efficacy, which may lead to quantifiable advances in device development and eventual improved clinical outcomes.
摘要：
背景：缺血性卒中是全球范围内死亡和严重长期残疾的主要原因。机械血栓切除术正在成为符合条件的患者的标准治疗方法。随着支架取出和血栓抽吸术的临床实施增加，需要生理相关的体外装置功效测试。这项测试的关键是开发标准化的“软”和“硬”合成血凝块，这些血凝块模仿人类血栓的特性，并与成像技术兼容。合成凝块允许研究人员提取有关凝块整合的信息，模型血液动力学，量化血栓切除术的物理原理。
方法：这项工作开发了基于聚丙烯酰胺和藻酸盐的合成凝块，这些凝块与粒子图像测速（PIV）和射线照相成像技术兼容，同时保持了“软”和“硬”的机械性能。使用HR2-流变仪的动态机械分析测试证明了与该研究小组先前测试并在现有文献中提供的人类凝块相当的机械性能。
结果：合成凝块用0.5%w/v聚乙烯微球配制用于PIV可视化，或用20%w/v硫酸钡配制用于血管造影可视化。在血栓切除术模拟过程中，能够实时成像凝块行为。软配方显示〜12kPa和2-3kPa的压缩和剪切性能，分别。硬凝块硬3-4倍，具有41-42kPa和8-9kPa的压缩和剪切性能，分别。
结论：标准化合成凝块为可重复的设备测试提供了平台。这提供了对机械取栓装置功效的更多了解，这可能导致器械开发的可量化进展和最终改善的临床结果。
方法：这项工作开发了基于聚丙烯酰胺和藻酸盐的合成凝块，这些凝块与粒子图像测速（PIV）和射线照相成像技术兼容，同时保持了“软”和“硬”的机械性能。使用HR2-流变仪的动态机械分析测试证明了与该研究小组先前测试并在现有文献中提供的人类凝块相当的机械性能。
结果：合成凝块用0.5%w/v聚乙烯微球配制用于PIV可视化，或用20%w/v硫酸钡配制用于血管造影可视化。在血栓切除术模拟过程中，能够实时成像凝块行为。软配方显示〜12kPa和2-3kPa的压缩和剪切性能，分别。硬凝块硬3-4倍，具有41-42kPa和8-9kPa的压缩和剪切性能，分别。
结论：标准化合成凝块为可重复的设备测试提供了平台。这提供了对机械取栓装置功效的更多了解，这可能导致器械开发的可量化进展和最终改善的临床结果。
