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.
MangiavillanoBMontaleAFrazzoniL, et al. Endoscopic biliary self-expandable metallic stent in malignant biliary obstruction with or without sphincterotomy: systematic review and meta-analysis. Endosc Int Open2019; 7(1): E26–E35.
3.
MoyBTBirkJW. An update to hepatobiliary stents. J Clin Transl Hepatol2015; 3(1): 67–77.
4.
NakaokaKHashimotoSKawabeN, et al. Evaluation of a 12-mm diameter covered self-expandable end bare metal stent for malignant biliary obstruction. Endosc Int Open2018; 6(10): E1164–E1170.
5.
SejpalD. Advancements in biliary stenting. J Clin Gastroenterol2012; 46(3): 191–196.
6.
SungJYCostertonJWShafferEA. Defense system in the biliary tract against bacterial infection. Dig Dis Sci1992; 37(5): 689–696.
7.
HuBWangTTShiZM, et al. A novel antireflux metal stent for the palliation of biliary malignancies: a pilot feasibility study (with video). Gastrointest Endosc2011; 73(1): 143–148.
8.
MisraSPDwivediM. Reflux of duodenal contents and cholangitis in patients undergoing self-expanding metal stent placement. Gastrointest Endosc2009; 70(2): 317–321.
9.
Van BerkelAMVan MarleJGroenAK, et al. Mechanisms of biliary stent clogging: confocal laser scanning and scanning electron microscopy. Endoscopy2005; 37(8): 729–734.
10.
HuBWangTTWuJShiZMGaoDJPanYM. Antireflux stents to reduce the risk of cholangitis in patients with malignant biliary strictures: a randomized trial. Endoscopy2014; 46(2): 120–126.
11.
LeeKJChungMJParkJY, et al. Clinical advantages of a metal stent with an S-shaped anti-reflux valve in malignant biliary obstruction. Dig Endosc2013; 25(3): 308–312.
12.
DuaKSReddyNDRaoVG, et al. Impact of reducing duodenobiliary reflux on biliary stent patency: an in vitro evaluation and a prospective randomized clinical trial that used a biliary stent with an antireflux valve. Gastrointest Endosc2007; 65(6): 819–828.
13.
LeeYNMoonJHChoiHJ, et al. Effectiveness of a newly designed antireflux valve metal stent to reduce duodenobiliary reflux in patients with unresectable distal malignant biliary obstruction: a randomized, controlled pilot study (with videos). Gastrointest Endosc2016; 83(2): 404–412.
14.
HamadaTIsayamaHNakaiY, et al. Antireflux covered metal stent for nonresectable distal malignant biliary obstruction: amulticenter randomized controlled trial. Dig Endosc2019; 31(5): 566–574.
15.
KimDUKwonCIKangDH, et al. New antireflux self-expandable metal stent for malignant lower biliary obstruction: in vitro and in vivo preliminary study. Dig Endosc2013; 25(1): 60–66.
16.
LeongQWShenMLAuKW, et al. A prospective, randomized study of the patency period of the plastic antireflux biliary stent: an interim analysis. Gastrointest Endosc2016; 83: 387–393.
17.
MoritaSAraiYSugawaraS, et al. Antireflux metal stent for initial treatment of malignant distal biliary obstruction. Gastroenterol Res Pract 2018; 2018: 3805173.
18.
VihervaaraHGronroosJMHurmeS, et al. Antireflux versus conventional plastic stent in malignant biliary obstruction: a prospective randomized study. J Laparoendosc Adv Surg Tech A2017; 27(1): 53–57.
19.
KwonCIMoonJPYunH, et al. Evaluation of valve function in antireflux biliary metal stents. BMC Gastroenterol2018; 18(1): 150.
20.
HamadaTNakaiYIsayamaH, et al. Against duodenobiliary reflux: implications from a randomized controlled trial. Gastrointest Endosc2016; 83(3): 673–674.
21.
YangMJKimJHHwangJC, et al. Can anti-reflux metal stent make the stent patency longer in patients with inoperable malignant distal biliary obstruction?Gastrointest Endosc2017; 85(5): AB218.
22.
BianchiMMaromGGhoshRP, et al. Patient-specific simulation of transcatheter aortic valve replacement: impact of deployment options on paravalvular leakage. Biomech Model Mechanobiol2019; 18(2): 435–451.
23.
LiZYYanFYangJR, et al. Hemodynamics and oxygen transport through pararenal aortic aneurysm treated with multilayer stent: a numerical study. Ann Vasc Surg2019; 54: 290–297.
24.
McGrathDJThiebesALCornelissenCG, et al. Evaluating the interaction of a tracheobronchial stent in an ovine in-vivo model. Biomech Model Mechanobiol2018; 17(2): 499–516.
25.
PeirlinckMDebusschereNIannacconeF, et al. An in silico biomechanical analysis of the stent-esophagus interaction. Biomech Model Mechanobiol2018; 17(1): 111–131.
26.
PuertolasSBajadorEPuertolasJA, et al. Study of the behavior of a bell-shaped colonic self-expandable NiTi stent under peristaltic movements. Biomed Res Int2013; 2013: 370582.
27.
RibeiroNSFolgadoJRodriguesHC. Surrogate-based visualization and sensitivity analysis of coronary stent performance: a study on the influence of geometric design. Int J Numer Meth Biomed Eng2018; 34(10): 28.
28.
GökgölCDiehmNNezamiFR, et al. Nitinol stent oversizing in patients undergoing popliteal artery revascularization: a finite element study. Ann Biomed Eng2015; 43(12): 2868–2880.
29.
QiaoAZhangZ. Numerical simulation of vertebral artery stenosis treated with different stents. J Biomech Eng2014; 136(4): 9.
30.
KhodadadiALiaghatGAhmadiH, et al. Numerical and experimental study of impact on hyperelastic rubber panels. Iranian Polymer Journal2019; 28(2): 113–122.
31.
AvanziniABattiniD. Integrated experimental and numerical comparison of different approaches for planar biaxial testing of a hyperelastic material. Adv Mater Sci Eng. 2016: 12.
32.
Al-AtabiMChinSBLuoXY. Experimental Investigation of the flow of bile in patient specific cystic duct models. J Biomech Eng2010; 132(4): 6.
33.
OoiRCLuoXYChinSB, et al. The flow of bile in the human cystic duct. J Biomech2004; 37(12): 1913–1922.
34.
KuchumovA. Biomechanical modelling of bile flow in the biliary system. In: VassilevVMNikolovSGDatchevaMD, et al. (eds) 13th National Congress on Theoretical and Applied Mechanics. Cedex A: E D P Sciences, 2018.
35.
AndersenMBGregersenHKraglundK, et al. Radial analysis of duodenal motility recordings in humans. Scand J Gastroenterol1991; 26(8): 843–851.
36.
PauckRGReddyBD. Computational analysis of the radial mechanical performance of PLLA coronary artery stents. Med Eng Phys2015; 37(1): 7–12.
37.
AuricchioFTaylorRL. Shape-memory alloys: modelling and numerical simulations of the finite-strain superelastic behavior. Comp Method Appl M1997; 143(1–2): 175–194.
38.
AzaouziMMakradiABelouettarS. Deployment of a self-expanding stent inside an artery: a finite element analysis. Mater Des2012; 41: 410–420.
39.
PetriniLMigliavaccaFAuricchioF, et al. Numerical investigation of the intravascular coronary stent flexibility. J Biomech2004; 37(4): 495–501.
40.
YinLLuoZZhongJ, et al. Behaviour and mechanism of fatigue crack growth in aramid-fibre-reinforced styrene–butadiene rubber composites. Int J Fatigue2020; 134: 105502.
41.
Legorju-jagoKBathiasC. Fatigue initiation and propagation in natural and synthetic rubbers. Int J Fatigue2002; 24(2–4): 85–92.
42.
HamadaTIsayamaHNakaiY, et al. Novel antireflux covered metal stent for recurrent occlusion of biliary metal stents: a pilot study. Dig Endosc2014; 26(2): 264–269.
43.
IsayamaHKawabeTNakaiY, et al. Management of distal malignant biliary obstruction with the ComVi stent, a new covered metallic stent. Surg Endosc2010; 24(1): 131–137.
44.
HamadaTIsayamaHNakaiY, et al. Antireflux metal stent with an antimigration system for distal malignant biliary obstruction: a feasibility pilot study. Surg Laparosc Endosc Percutan Tech2015; 25(3): 212–217.
45.
KuchumovAGGilevVPopovV, et al. Non-Newtonian flow of pathological bile in the biliary system: experimental investigation and CFD simulations. Korea-Aust Rheol J2014; 26(1): 81–90.
46.
KuchumovAGNyashinYISamarcevVA, et al. Modelling of the pathological bile flow in the duct with a calculus. Acta Bioeng Biomech2013; 15(4): 9–17.
47.
LiWGLuoXYChinSBHillNAJohnsonAGBirdNC. Non-newtonian bile flow in elastic cystic duct: one- and three-dimensional modeling. Ann Biomed Eng2008; 36(11): 1893–1908.
