Balloon catheters are a key technology in medical devices, essential for minimally invasive procedures. This study quantitatively analyzes how the orientation characteristics of polymer tubes, influenced by extrusion conditions, affect the mechanical properties and compliance of the final balloon—where compliance refers to the change in diameter under external pressure. Nylon 12 tubes, with a target outer diameter of 1.2 mm and an inner diameter of 1.0 mm, were extruded under six different orientation conditions by varying the screw flow rate and puller speed. The tubes were processed under identical forming conditions, allowing for a consistent evaluation of their mechanical properties. As orientation increased, elongation decreased while yield strength increased, and these trends continued in the balloon, significantly influencing compliance. To quantitatively measure orientation, we introduced the dimensionless Deborah number. We established a curve-fitted experimental model that links extrusion conditions, polymer tube properties, and balloon compliance. This model allows for the prediction of balloon performance based on extrusion-stage parameters, providing a practical framework for process optimization. Overall, this study offers an effective quantitative indicator for forecasting balloon catheter performance based on extrusion conditions and supports the systematic design of medical balloon products.

As the market for minimally invasive procedures developed rapidly, there was an increase in the demand for high-precision, high-performance catheter fabrication technology. Sheath and dilator tubes are essential intervention devices for procedures, in which catheters are used and require precise dimensional accuracy, and uniform roundness and surface roughness. Polyethylene is used in sheath and dilator limitation for processability, which causes low melt flow index and side effects. Therefore, in the extrusion process using polyethylene, it is important to study the manufacturing of tubes with improved roundness and surface roughness. In this study, we proposed a calibrator for precise production with an aim to manufacture 5Fr micro-puncture tubes, and studied the changes in the roundness and surface roughness of tubes by changing the cooling water temperature and water disk thickness. As a result, it was found that the cooling water temperature and wafer disk thickness had an effect on the roundness and surface roughness, and the roundness had an effect on the formation of the wall thickness. Therefore, these experimental results were used as a study for the production of improved Sheath and Dilator tubes.