Mechanical properties and degradation process of biliary self-expandable biodegradable stents.

Abstract

The clinical outcomes and prevalence of adverse events associated with biliary biodegradable stents (BS) can differ according to degradation process and time. The aim of this study was to observe the degradation process and time of different BS prototypes, and to evaluate sequential changes in their mechanical properties. Using an invitro bile flow phantom model, we compared degradation time, radial force changes, and morphologic changes among four different BS prototypes: polydioxanone (PDO) BS, polyglycolide (PGA) BS, polydioxanone/poly-l-lactic acid (PDO/PLLA) sheath-core BS, and polydioxaone/magnesium (PDO/Mg) sheath-core BS. Using an invivo swine bile duct dilation model, we performed a direct peroral cholangioscopy (DPOC) examination to observe the biodegradation process and related adverse events at regular intervals. In the bile flow phantom model, the PGA BS and PDO/Mg BS prototypes showed rapid radial force reduction and morphological changes and complete degradation within six weeks. PDO/PLLA BS maintained high radial force and kept their original shape for longer than the PDO BS, up to 16 weeks. A total of 24 BS were inserted into the dilated bile ducts of 12 swine. In this animal model, DPOC examination revealed that PDO BS and PDO/PLLA BS maintained their original shapes for approximately 12 weeks, but PDO BS showed a greater degree of fragmentation and induced biliary stones and bile duct obstruction. Our results showed that PDO/PLLA BS maintained their original shape and radial force for a relatively long time and minimized adverse events.