经皮腔内冠状动脉成形术球囊导管的设计。

School of Biomedical and Precision Engineering, University of Bern, Güterstrasse 24/26, CH-3008, Bern, Switzerland.

SMD Swiss Medical Devices, Beringen, Switzerland.

Biomed Eng Online. 2023 Sep 23;22(1):94. doi: 10.1186/s12938-023-01155-2.

BACKGROUND

Eight commercially available percutaneous transluminal coronary angioplasty (PTCA), including semi-compliant and non-compliant balloons, have been assessed in detail on their tip, balloon, shaft, RX-Port, and hypotube design. Important performance characteristics such as tip deformation, balloon elongation, and deflation rate have been quantified.

METHODS

Five catheters of each model were evaluated during various tests. The robustness of the tips was evaluated through compression, measuring any occurrence of damage. The longitudinal growth of the balloons was recorded during inflation up to Rated Burst Pressure (RBP). The forces required to move the catheter forward and retract it into the guide catheter were measured in a simulated use test setup. The deflation behavior was studied by measuring extracted contrast media over time. Furthermore, balloon compliance and catheter dimensions were investigated.

RESULTS

The outer dimensions of the catheter were found to be smallest at the hypotube (0.59-0.69 mm) and highest at the balloon, respectively, the crossing profile (0.9-1.2 mm). The tip diameter increased after compression by 1.7-22%. Cross-sections of the folded balloons revealed a tri- and two-fold, respectively. The measured balloon elongation ranged from 0.6 to 2.0 mm. After the inflation of the balloon, an increase in friction between the guide wire and the catheter was observed on four catheters. A maximum increase of 0.12 N to 1.07 N was found. Cross-sections of the RX-Port revealed a semicircular-shaped inflation lumen and a circular guide wire lumen. The measured deflation rate ranged from 0.004 to 0.013 µL/s, resulting in an estimated balloon deflation time of 10.2-28.1 s.

CONCLUSION

This study provides valuable insights into the design characteristics of RX PTCA balloon catheters, which can contribute to facilitating the development of improved catheter designs and enhancing clinical outcomes. Distinctions between SC and NC catheters, such as balloon performance and dimensions, are evident. It is important to note that no single catheter excels in all aspects, as each possesses unique strengths. Therefore, it is essential to consider individual intervention requirements when selecting a catheter. The research also identifies specific catheter weaknesses, such as reduced wall thickness, fringes at the tip, and reduced performance characteristics.

背景

对 8 种市售的经皮腔内冠状动脉成形术（PTCA），包括半顺应性和非顺应性球囊，从尖端、球囊、轴、RX-Port 和鞘管设计等方面进行了详细评估。已经量化了重要的性能特征，如尖端变形、球囊膨胀和放气速率。

方法

对每种型号的 5 个导管进行了各种测试。通过压缩来评估尖端的坚固性，测量任何损坏的发生。在充气至额定破裂压力（RBP）的过程中记录球囊的纵向生长。在模拟使用测试设置中测量向前推动导管和将其缩回导引导管所需的力。通过随时间测量提取的对比介质来研究放气行为。此外，还研究了球囊顺应性和导管尺寸。

结果

导管的外径在鞘管处最小（0.59-0.69mm），在球囊处最大（0.9-1.2mm），交叉轮廓最大。尖端直径在压缩后增加了 1.7-22%。折叠球囊的横截面分别为三折和两折。测量的球囊膨胀长度范围为 0.6-2.0mm。在球囊充气后，发现导丝和导管之间的摩擦在四个导管上增加。最大增加 0.12N 到 1.07N。RX-Port 的横截面显示出一个半圆形的充气腔和一个圆形的导丝腔。测量的放气速率范围为 0.004 到 0.013µL/s，这导致估计的球囊放气时间为 10.2-28.1s。

结论

本研究深入了解了 RX PTCA 球囊导管的设计特点，有助于促进改进的导管设计的发展和改善临床结果。SC 和 NC 导管之间存在明显差异，如球囊性能和尺寸。需要注意的是，没有一种导管在所有方面都表现出色，因为每种导管都有其独特的优势。因此，在选择导管时，必须考虑到个体干预需求。该研究还确定了特定的导管弱点，如壁厚度减小、尖端的边缘和性能特征降低。