Abstract
At present, percutaneous coronary intervention (PCI) is the most effective treatment of coronary artery stenosis. However, in case post-dilation of the stent is needed, the tip of the commonly used post-dilation balloon catheter cannot always pass through the stent smoothly, especially when it is situated in the curved part of the vessel. To improve the performance of traditional post-dilation balloon catheter, a preliminary design of a novel catheter with a spherical-tip is proposed. Since the performance of this spherical-tip catheter is still unclear, in this study, finite element analysis (FEA) and experimental validation of blood vessel with different curvature radii were performed to test and evaluate the performance of the spherical-tip catheter design. The comparative results between the two types of catheters demonstrate that in the simulated post-dilation process, the spherical-tip catheter is easier to pass through the stent placed in the curved vessel without the deformation of the stent strut, and can theoretically reduce the operation time and improve the safety of the operation. Furthermore, the strong consistency between simulation and experiment indicates that the finite element (FE) model can be a helpful tool for future optimization and evaluation of novel catheters, so as to save time and budget in product development and reduce/replace animal studies.
Highlights
In recent years, the incidence and mortality of coronary heart disease (CHD) have increased significantly (Gagnier et al, 2010; Liu et al, 2012)
This study aims to demonstrate the better passability of the novel catheter by comparing it to a commonly used one in curved vessel, and a reasonable simplification was made
A straight stent strut and a slanted stent strut were compared in this model because the catheter may contact the different parts of the stent
Summary
The incidence and mortality of coronary heart disease (CHD) have increased significantly (Gagnier et al, 2010; Liu et al, 2012). It is estimated that by 2020, the death rate of coronary heart disease will increase by 50% (approximately 25 million people per year) (Anderson et al, 2016). Postdilation refers to in-stent dilation of the balloon after stent deployed, applying a higher pressure than that used during stent implantation. This operation is performed to ensure the complete attachment between the stent and the vascular wall, which reduces the probability of in-stent thrombosis and the rate of restenosis after the operation (see Figure 1B). Balloon postdilation has been developed as an option to reduce the degree of aortic regurgitation (Nombela-Franco et al, 2012), and there is no stenosis in the pathway of the post-dilation catheter
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