Bile Flow Phantom Model and Animal Bile Duct Dilation Model for Evaluating Biliary Plastic Stents with Advanced Hydrophilic Coating

ABSTRACT

BACKGROUND/AIMS: The efforts to improve biliary plastic stents (PSs) for decreasing biofilm formation and overcome short patency time have been continued. The aim of this study is to evaluate the effect of advanced hydrophilic coating for patency and biodurability of PS. METHODS: Using an in vitro bile flow phantom model, we compared patency between prototype PS with hydrophilic coating (PS+HC) and prototype PS without hydrophilic coating (PS-HC). We performed an analysis of the degree of luminal narrowing by microscopic examination. Using an in vivo swine bile duct dilation model made by endoscopic papillary closure and stent insertion, we evaluated biodurability of hydrophilic coating. RESULTS: In the phantom model, PS+HC showed less biofilm formation and luminal narrowing than PS-HC at 8 weeks (p<0.05). A total of 31 stents were inserted into the dilated bile duct of seven swine models, and 24 stents were successfully retrieved 8 weeks later. There was no statistical difference of stent patency between the polyethylene PS+HC and the polyurethane PS+HC. The biodurability of hydrophilic coating was sustained up to 8 weeks, when assessing the coating layer by scanning electron microscopy examination. CONCLUSIONS: Advanced hydrophilic coating technology may extend the patency of PS compared to uncoated PS.