Partially covered, self-expandable metal stents with anti-reflux valves for malignancies comprising hilar region

Authors

ANDRAŠINA Tomáš KANG Sung Kwon MOON Jong Ho GROLICH Tomáš CRHA Michal

Year of publication 2015
Type Conference abstract
MU Faculty or unit

Faculty of Medicine

Citation
Description Objective: To prove feasibility of percutaneous parallel implantation of partially covered, self-expandable metal stents (PC-SEMS) with antireflux valves (AR valves) in in-vivo model. Method: The novel design of PC-SEMS suitable for patients with hilar malignancies was developed. For percutaneous implantation of stent with AR valve, specific type of introducer is needed to prevent closing and crumpling of valve during implantation procedure. Stent is half covered with e-PTFE membrane, also forming AR valve. Proximal half of the stent is bare to allow flow of bile from segmental branches of biliary tree arising in hilar region. In-vivo experiment was chosen to test safe deployment of two PC-SEMS with AR valve. Parallel and synchronous implantation of stents was used in cross-bred piglet model. The procedure was performed under general anaesthesia with simulation of percutaneous approach. Open laparotomic view of duodenum was used for observation of AR valve. One week later the experimental model was euthanized and autopsy was performed to assess stent patency, presence of intraluminal content and function of AR valve. Results: The implantation of SEMS with AR valve is performed with an extra step. By retrieving of stent introducer sheath, a metal bumper which maintains the open position of antireflux valve is opened. The extra step of recapturing metal bumper is needed to safely remove the introducer system. For the synchronous and parallel implantation of two stents whole process of implantation was completed without collision or affecting the AR valve system. The extra step prolonged the procedure insignificantly (8 and 9 seconds). The autopsy of model proved full patency of SEMS and AR valve. No intraluminal content was found inside the stents. Conclusion: The new self expandable partially covered stent with antireflux valve is suitable for parallel and synchronous percutaneous implantation. No significant reflux was observed during experimental period.

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