Traumatic vascular injuries, resulting from either civilian accidents or wounded soldiers, require new endovascular devices (i.e., stent graft) to rapidly control the excessive internal hemorrhage in torso region. Current stent designs are limited by their permanent nature, which is note well suited for emergent placement. A retrievable stent graft could regulate the internal bleeding temporarily, as fast as possible with the most feasible performance, until the patients arrive the hospital to receive the proper treatment. The novel endovascular device of this study is designed according to the anatomy of a porcine model with plans to transition to a human model in the future. The stent graft is manufactured using a substantially long nitinol backbone and covered selectively based on anatomic measurements, with highly stretchable expanded‐polytetrafluoroethylene (ePTFE). In this study, our group comprehensively explored designing and manufacturing methods, and their impact on the stent graft performance. Geometric parameters and heat treatment conditions were investigated to show their effect on the radial force of the metallic backbone. As a retrievable device, the resistance force for retrieval as well as deployment were measured, and analyzed to be manipulated through ePTFE covering configurations. In vitro measurements for bleeding were measured using swine aorta to show the functionality of the stent graft under the simulated pulsatile flow circulation. Finally, the stent graft showed substantial effectiveness for hemorrhage control in vivo, using swine model. The new design and fabrication methods enable rapid hemorrhage control that can be removed at the time of a dedicated surgical repair.

中文翻译：

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综合评估极长覆膜支架控制躯干出血的机械性能。

由平民事故或受伤士兵引起的创伤性血管损伤需要新的血管内装置（即支架移植物）来快速控制躯干区域的过度内出血。当前的支架设计受其永久性的限制，这很适合紧急放置。可回收覆膜支架可以临时调节内出血，尽快以最可行的性能，直到患者到达医院接受适当的治疗。本研究的新型血管内装置是根据猪模型的解剖结构设计的，并计划在未来过渡到人体模型。支架移植物使用相当长的镍钛诺骨架制造，并根据解剖学测量有选择地覆盖，具有高度可拉伸的膨体聚四氟乙烯 (ePTFE)。在这项研究中，我们小组全面探索了设计和制造方法，及其对覆膜支架性能的影响。研究了几何参数和热处理条件，以显示它们对金属骨架径向力的影响。作为一种可回收装置，对回收和展开的阻力进行了测量和分析，以便通过 ePTFE 覆盖配置进行操作。使用猪主动脉对出血进行体外测量以显示支架移植物在模拟脉动流动循环下的功能。最后，使用猪模型，支架移植物显示出对体内出血控制的显着有效性。