Development Of Novel Diagnostic Angiographic Catheter, Evaluation of Its Efficacy, Precision, And Ease of Application

Abstract

Cardiovascular diseases are a leading cause of death globally, accounting for approximately onethird of all deaths. The prevalence of coronary disease continues to rise, resulting in increased mortality rates and escalating healthcare costs. The gold standard for diagnosing coronary blockages and recommending therapeutic interventions is angiography. Currently, braided reinforced shafts are the most common construction material for catheters used in angiographic procedures. However, recent research has focused on the development of laser-cut reinforced shaft catheters. The aim of this study was to assess the potential usage of laser-cut reinforced shaft-based angiographic catheters for coronary angiographic procedures by analyzing their design, performance, and behaviour. The commercially available state-of-the-art angiographic catheters comprise of braidedreinforced shafts, while the laser-cut reinforced shaft technique has never been used to develop angiographic catheters despite its potential to reduce the wall thickness and consequently the profile of the catheters without compromising pushability and flexibility. Therefore, the objective of this study was twofold: (I) designing and manufacturing a laser-cut metallic reinforced shaft in a novel way and (II) configuring this novel laser-cut metallic shaft as a lasercut reinforced angiography catheter to improve the existing state-of-the-art (braided catheter) by reducing profile (wall-thickness), enhancing flow rate, flexural and tensile strength, and decreasing pushability force required. The developed laser-cut angiographic catheter (having an outer diameter of 2.00 mm) has a wall thickness of 0.2 mm which is approximately 33% less than that of the commercially available braided catheters (having a wall thickness of 0.3mm). Furthermore, the pushability force analysis results prove that laser-cut reinforced shaft catheter exerts a minimal resistive force (625g) which is approximately 1/3rd times less than that of the braided catheter. Needless to mention that the novel Laser-cut catheter exhibits 2x more tensile strength than the commercially available braided catheter. The fabrication route employed in this study also increased the catheter's hydrophilicity (contact angle of 71.3°); as a result, an additional hydrophilic coating is not required. The outcome of the comparative analysis, based on the results obtained from the manufacturing route and bench testing, clearly shows that the laser cutting method is an effective and rapid way of producing flexible, lower-profile reinforced shaft. It is also established that the use of this method to produce flexible lower profile reinforced shaft will overcome the problem of compromised radial strength during a diagnostic procedurexxvii and would help maintain continuous ovality throughout. Therefore, the developed laser-cut reinforced catheter may potentially be used as the next state-of-the-art angiographic catheter after further in vivo and clinical testing