Background
Biliary balloon catheters play a crucial role in the diagnosis and treatment of biliary tract disorders, including bile duct strictures, obstructions, and stone retrieval. In-vitro studies provide a controlled environment to evaluate the catheter's mechanical properties, expansion characteristics, and compatibility with endoscopic and fluoroscopic guidance before clinical use.
Objective
The prsenet study aims to assess the performance of a biliary balloon catheter under in-vitro conditions, focusing on balloon expansion dynamics, pressure resistance, material durability, and the efficacy to dilate narrow duct segments.
Methods
A laboratory-based experimental setup was designed to simulate biliary conditions using synthetic bile duct models with varying lumen diameters. The balloon catheter was tested under different inflation pressures (ranging from 4 to 10 atm) to evaluate radial force distribution, uniform expansion, and potential risk of rupture. The catheter material (comprising medical-grade polyurethane with hydrophilic coating) was examined for Kink Free Navigation, Performance under stress, Smooth Guidewire Tracking, Guidewire-Catheter Interaction, Balloon Performance and Durability, Balloon deflation efficiency.
Results
The biliary balloon catheter demonstrated consistent and uniform expansion at pressures between 4 and 8 atm, with a rupture threshold exceeding 12 atm. The hydrophilic coating facilitated smooth insertion and withdrawal, reducing friction by 35% compared to non-coated alternatives.
Conclusion
This in-vitro study confirms the efficacy and mechanical reliability of the biliary balloon catheter for endoscopic retrograde cholangiopancreatography (ERCP) procedures. The findings suggest a strong potential for clinical application, warranting further in-vivo validation and comparative studies with existing biliary dilation.
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