RESUMO
PURPOSE: Current steerable catheters (SCs) for endoscopic retrograde cholangiopancreatography (ERCP) have performance limitations caused by an asymmetric multiple-slit tube design with a small maximum bend angle, lesser curvatures, and insufficient durability. We propose a wire-driven SC for balanced bidirectional bending using artificial blood vessel material to overcome these limitations. We assess the SC prototype's steerability using phantom and animal models. METHODS: The SC prototype employed a slit-less and multiple-lumen seamless tube with a polytetrafluoroethylene (PTFE) body with stretch-retractable porous expanded PTFE at the distal end, and loop-formed control wires. We evaluated the wire routing design using a static model. The bending performance was compared with conventional SCs. Feasibility studies were performed, including major duodenal papilla insertions and ductal branch selections in desktop phantoms and a mini-pig model. RESULTS: The proposed design reduced the wire contact force by 48% compared to the single wire configuration. The maximum bend angle was 162°, almost twofold larger than that for conventional SCs. The lateral tip position in the bent shape was maximally 56% smaller. The tip flexibility was comparable to conventional SCs, and the insertion resistance was similar to the passive catheters. Phantom studies showed that the SC prototype could perform the large and protuberant papilla insertions and fine ductal branch selections without breaking; the animal study was completed successfully. CONCLUSION: We propose a wire-driven SC design for ERCP using a multi-lumen seamless tube and two loop-formed control wires, different from the conventional SC design with a multiple-slit tube and single control wire. The SC prototype records balanced bidirectional bending with a maximum bending angle of ± 162° without breakage risk. The phantom and animal studies show that the prototype performance potentially facilitates papilla cannulations and intrahepatic ductal branch seeking.
