Anti-reflux devices for preventing intraluminal reflux through double-J stents using elastomer casting process

Abstract

This study develops check valve-shaped flexible devices for perfect prevention of intraluminal reflux in patients with indwelling double-J (DJ) stent, with side hole effects ignored. These can be assembled with the penta-shaped extraluminal anti-reflux device, developed in our previous work to determine anti-reflux efficiency via in vitro study. The intraluminal anti-reflux devices (IADs) were fabricated by casting process with various elastomers, with a three-dimensional printer. Based on the elastomers, four types of IADs were manufactured, and intraluminal anti-reflux performances were demonstrated with respect to the elastomers. Consequently, the Ecoflex 00–50 based IAD demonstrated the best anti-reflux performance that perfectly prevented reflux in our J-shaped experimental setup and ensured the highest broken load between a valve and body of the IAD. Moreover, the IAD provided smooth urine drainage and was durable under 4500 open and close cycles without significant change in anti-reflux performance. In experimental results, the IAD with the DJ stent prevented the intraluminal reflux perfectly when both the side holes were closed, and extraluminal space was blocked. To mitigate vesicoureteral reflux symptoms, the IAD is expected to be used in case of side holes-free DJ stent located in the bladder and blocked extraluminal space.