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评估不同经皮硬膜外神经成形术导管的技术规格和临床性能。

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

作者信息

Jang Ji Young, Vuttipongkul Songrit, Jang Dong Soon, Chang Min Cheol

机构信息

Department of Neurosurgery, Armed Forces Yangju Hospital, Yangju, Korea.

Division of Neurosurgery, Department of Surgery, Siriraj Hospital, Mahidol University, Bangkok, Thailand.

出版信息

Neurospine. 2025 Jun;22(2):465-472. doi: 10.14245/ns.2550684.342. Epub 2025 Jun 30.

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 positional 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.

摘要

目的

本研究旨在评估和比较市售经皮硬膜外神经成形术(PEN)导管的结构和功能特性。还研究了导管特性之间的相关性,以确定对临床实践的潜在影响。

方法

分析了来自不同制造商的9种PEN导管产品。评估了各种物理特性,包括导管直径、长度、杠杆旋转角度、弯曲度和推进力。在最大和半最大杠杆旋转角度下,分别在插入和未插入导丝的情况下测量弯曲度。通过测量导管尖端与电子秤盘接触时产生的压力来确定推进力。采用Wilcoxon符号秩检验和Spearman相关性检验进行统计分析。

结果

导管在结构和功能特性上表现出相当大的差异。导管的平均直径和长度分别为2.0±0.6mm和287.8±30.3mm;平均杠杆旋转角度为57°±21°。当操纵杆旋转到其最大允许角度时,相对于导丝在位状态,导丝不在位状态下近端弯曲角度显著增加,这表明在柔韧性和结构支撑之间存在权衡。不同产品的推进力差异显著;观察到导管直径与推进力之间呈正相关。

结论

本研究发现不同产品的导管特性存在显著差异。移除导丝后导管柔韧性增加可能导致位置不稳定,在PEN手术过程中需要仔细考虑。较大的导管直径与增加的推进力相关,这可能会影响插入的难易程度和患者的舒适度。这些发现强调了需要标准化PEN导管规格,以优化临床实践中的安全性和有效性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4075/12242728/499226fdc470/ns-2550684-342f1.jpg

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