Ex vivo evaluation of anti-migration forces of ureteral self-expanding metal stents with different flange designs
摘要
To evaluate the anti-migration forces of ureteral self-expanding metal stents (SEMS) with various flange designs. In the initial study, 240 fresh porcine ureters were divided into ten groups to evaluate ten custom-made SEMS (Type I–X). Type I and II lacked flanges (8 mm and 10 mm diameters, respectively), while Types III–X had various proximal flange designs. In the subsequent study, 96 ureters were divided into four groups to evaluate four SEMS: a custom-made prototype with the same flange design as Type X (double-stepped shoulders) and three commercial stents, including Urexel, Uventa, and Allium. Proximal and distal anti-migration forces were measured using a universal testing machine. In the initial study, only Type X demonstrated a significantly higher distal anti-migration force than the 8-mm non-flanged SEMS (Type I) (P = 0.001). None of the SEMS (Types II–X) showed significantly higher proximal anti-migration force compared to Type I (all > 0.05). In the subsequent study, Uventa demonstrated significantly higher proximal and distal anti-migration forces than the prototype (P < 0.001 and P = 0.001, respectively). The prototype demonstrated significantly higher proximal and distal anti-migration forces than Urexel (both P < 0.001). Allium unraveled during initial testing and was excluded from the analysis. Only the double-stepped shoulders improved distal anti-migration force among eight flange designs. Compared with commercial SEMS, the prototype featuring this design demonstrated higher anti-migration force than Urexel but lower than Uventa.