Evaluating the Technical Specifications and Clinical Performance of Different Percutaneous Epidural Neuroplasty Catheters

Abstract

Objective: This study aimed to evaluate and compare the structural and functional characteristics of commercially available percutaneous epidural neuroplasty (PEN) catheters. Correlations among catheter properties were also examined to identify potential implications for clinical practice. Methods: Nine PEN catheter products from different manufacturers were analyzed. Various physical properties were assessed, including catheter diameter, length, lever rotation angle, bending degree, and advancing force. Bending degree was measured at maximal and half-maximal lever rotation angles, with and without the guidewire inserted. Advancing force was determined by measuring pressure generated at the catheter tip upon contact with the electronic scale plate. Wilcoxon signed-rank and Spearman correlation tests were used for statistical analysis. Results: Catheters exhibited considerable variations in structural and functional properties. The average catheter diameter and length were 2.0 ± 0.6 mm and 287.8 ± 30.3 mm, respectively; the mean lever rotation angle was 57° ± 21°. When the steering lever was rotated to its maximum allowable angle, proximal bend angle significantly increased in the wire-off state relative to the wire-on state, suggesting a trade-off between flexibility and structural support. Advancing force significantly varied across products; a positive correlation was observed between catheter diameter and advancing force. Conclusion: This study identified substantial variations in catheter characteristics across different products. Increased catheter flexibility after guidewire removal may lead to posi-tional instability, requiring careful consideration during PEN procedures. Larger catheter diameters were correlated with increased advancing force, which could influence ease of insertion and patient comfort. These findings emphasize the need for standardized PEN catheter specifications to optimize safety and efficacy in clinical practice.