Inam Hafsa, Ali Murtaza Najabat, Jameel Ibraheem Raza, Awaiz Dil, Qureshi Zunaira
Biomedical Engineering and Sciences Department, School of Mechanical and Manufacturing Engineering (SMME), National University of Sciences and Technology (NUST), Islamabad 44000, Pakistan.
N-ovative Health Technologies, NHT, National University of Sciences and Technology (NUST), Islamabad 44000, Pakistan.
Materials (Basel). 2024 Aug 28;17(17):4248. doi: 10.3390/ma17174248.
Keeping in mind the unceasingly escalating prevalence of coronary disease worldwide, the mortality rate is also expected to rise with a staggering increase in healthcare costs. Angiography is the gold standard for diagnosing these blockages that trigger these diseases. Amides and urethanes are the common catheter construction material used for angiography. However, the experimental evidence verifying the use of PEBAX and comparing its performance with that of commercially available catheters for angiography is not published despite it being well recognized for its excellent flexural modulus, mechanical properties, and biocompatibility and its potential to reduce the incidence of vascular spasm during intravascular diagnostic and interventional procedures. Therefore, the aim of this study was to develop a PEBAX-based angiographic catheter and evaluate its performance in comparison with three commercially available nylon- and polyurethane-based angiographic catheters.
A PEBAX-based angiographic catheter was developed for this purpose. This study analyzes and reports the performance and behavior of PEBAX-, nylon-, and polyurethane-based catheters. The catheter's performance and arterial forces' endurance nature were mapped out by evaluating pushability (advancement force) and selective bench tests outlined in the applicable regulatory standard.
The PEBAX-based catheter exhibited the least bond-flexural rigidity (180.4 g), which was approximately one-third of that shown by all six French catheters and which exhibited the least advancement force (510.4 g), which was approximately 50% less than that of the nylon- and polyurethane-based catheters when traversing through the mock arterial system. Bench testing was carried out as per the applicable regulatory standard; the differences obtained between individual catheters were discussed in detail. Based on this extensive in vitro assessment, it was concluded that the PEBAX-based catheters outperformed the nylon- and polyurethane-based catheters, exhibiting an exceptionally minimal advancement force of 510.4 g. This leads to the inference that this catheter can inject more radiopaque material (because of the enhanced flow rate) to the coronary arteries and can play a significant role in minimizing vascular spasms during a diagnostic procedure.
鉴于全球冠心病患病率不断攀升，预计死亡率也将上升，医疗成本将大幅增加。血管造影是诊断引发这些疾病的血管阻塞的金标准。酰胺和聚氨酯是血管造影常用的导管构建材料。然而，尽管PEBAX因其出色的弯曲模量、机械性能和生物相容性以及在血管内诊断和介入手术中降低血管痉挛发生率的潜力而广为人知，但尚未有实验证据证实其用于血管造影并将其性能与市售血管造影导管进行比较。因此，本研究的目的是开发一种基于PEBAX的血管造影导管，并与三种市售的基于尼龙和聚氨酯的血管造影导管比较其性能。
为此开发了一种基于PEBAX的血管造影导管。本研究分析并报告了基于PEBAX、尼龙和聚氨酯的导管的性能和行为。通过评估适用监管标准中概述的推送性（推进力）和选择性台架试验，描绘了导管的性能和动脉力的耐受特性。
基于PEBAX的导管表现出最小的粘结弯曲刚度（180.4克），约为所有六种法式导管的三分之一，并且在穿过模拟动脉系统时表现出最小的推进力（510.4克），比基于尼龙和聚氨酯的导管小约50%。根据适用的监管标准进行了台架试验；详细讨论了各导管之间的差异。基于这一广泛的体外评估，得出结论，基于PEBAX的导管优于基于尼龙和聚氨酯的导管，表现出异常小的510.4克推进力。由此推断，这种导管可以向冠状动脉注入更多的不透射线材料（由于流速增加），并且在诊断过程中可以在最大程度减少血管痉挛方面发挥重要作用。
