Endoscopic placement of biliary stent is a well-established palliative treatment for biliary obstruction. However, duodenobiliary reflux after stent placement has been a common problem which may lead to dreadful complications. This paper designed a novel anti-reflux biliary stent with a cone spiral valve. Fluid-Structure Interaction (FSI) simulations were established to evaluate the efficiency of the anti-reflux stent comparing with a clinically applied standard stent. According to the stress distribution of the valve, the fatigue performance in the stress concentration area was analyzed. The results show that when the antegrade flow through the valve, the cone spiral valve could stretch and open to realize adequate drainage under the normal physiological pressure of biliary tract; When the duodenal reflux through the valve, the valve would be compressed and close with a result of nearly zero at the outlet flow rate. Furthermore, the anti-reflux stent achieved improved radial mechanical performance with 2.7 times higher radial stiffness than standard stent. Finite element analysis (FEA) also indicates that compared with the standard stent, the addition of the anti-reflux valve had little negative effect on flexibility of the stent. Fatigue analysis results showed that the valve was reliable. This research provides the new stent with a cone spiral valve and proves that it is technically feasible and effective for preventing the duodenobiliary reflux while ensuring the antegrade bile flow without compromising the other biomechanical performances.

胆道支架内窥镜置入是一种行之有效的胆道梗阻姑息治疗。然而，支架置入后十二指肠反流是一个常见的问题，可能导致可怕的并发症。本文设计了一种新型的带有锥形螺旋瓣膜的抗反流胆道支架。建立了流体-结构相互作用 (FSI) 模拟以评估抗反流支架与临床应用标准支架的效率。根据阀门的应力分布，分析应力集中区的疲劳性能。结果表明，当顺行流经瓣膜时，在正常胆道生理压力下，锥形螺旋瓣可伸展打开，实现充分引流；当十二指肠经瓣膜回流时，阀门将被压缩并关闭，结果出口流速几乎为零。此外，抗反流支架的径向机械性能得到改善，径向刚度比标准支架高 2.7 倍。有限元分析（FEA）还表明，与标准支架相比，抗反流阀的加入对支架柔韧性的负面影响很小。疲劳分析结果表明该阀门是可靠的。该研究提供了带有锥形螺旋瓣膜的新型支架，并证明在保证胆汁顺行流动的同时，在不影响其他生物力学性能的情况下，它在防止十二指肠反流方面具有技术可行性和有效性。抗反流支架的径向机械性能得到改善，径向刚度比标准支架高 2.7 倍。有限元分析（FEA）还表明，与标准支架相比，抗反流阀的加入对支架柔韧性的负面影响很小。疲劳分析结果表明该阀门是可靠的。该研究提供了带有锥形螺旋瓣膜的新型支架，并证明在保证胆汁顺行流动的同时，在不影响其他生物力学性能的情况下，它在防止十二指肠反流方面具有技术可行性和有效性。抗反流支架的径向机械性能得到改善，径向刚度比标准支架高 2.7 倍。有限元分析（FEA）还表明，与标准支架相比，抗反流阀的加入对支架柔韧性的负面影响很小。疲劳分析结果表明该阀门是可靠的。该研究提供了带有锥形螺旋瓣膜的新型支架，并证明在保证胆汁顺行流动的同时，在不影响其他生物力学性能的情况下，它在防止十二指肠反流方面具有技术可行性和有效性。添加抗反流阀对支架的柔韧性几乎没有负面影响。疲劳分析结果表明该阀门是可靠的。该研究提供了带有锥形螺旋瓣膜的新型支架，并证明在保证胆汁顺行流动的同时，在不影响其他生物力学性能的情况下，它在防止十二指肠反流方面具有技术可行性和有效性。添加抗反流阀对支架的柔韧性几乎没有负面影响。疲劳分析结果表明该阀门是可靠的。该研究提供了带有锥形螺旋瓣膜的新型支架，并证明在保证胆汁顺行流动的同时，在不影响其他生物力学性能的情况下，它在防止十二指肠反流方面具有技术可行性和有效性。