Simulation and Experimental Investigation of Balloon Folding and Inserting Performance for Angioplasty: A Comparison of Two Materials, Polyamide-12 and Pebax

Tao Li; Zhuo Zhang; Wenyuan Wang; Aijia Mao; Yu Chen; Yan Xiong; Fei Gao

doi:10.3390/jfb14060312

Simulation and Experimental Investigation of Balloon Folding and Inserting Performance for Angioplasty: A Comparison of Two Materials, Polyamide-12 and Pebax

J Funct Biomater. 2023 Jun 5;14(6):312. doi: 10.3390/jfb14060312.

Authors

Tao Li¹, Zhuo Zhang¹, Wenyuan Wang², Aijia Mao³, Yu Chen³, Yan Xiong¹, Fei Gao²

Affiliations

¹ College of Mechanical Engineering, Sichuan University, Chengdu 610065, China.
² Chengdu Neurotrans Medical Technology Co., Ltd., Chengdu 610065, China.
³ Department of Applied Mechanics, Sichuan University, Chengdu 610065, China.

Abstract

Background: A balloon dilatation catheter is a vital tool in percutaneous transluminal angioplasty. Various factors, including the material used, influence the ability of different types of balloons to navigate through lesions during delivery.

Objective: Thus far, numerical simulation studies comparing the impacts of different materials on the trackability of balloon catheters has been limited. This project seeks to unveil the underlying patterns more effectively by utilizing a highly realistic balloon-folding simulation method to compare the trackability of balloons made from different materials.

Methods: Two materials, nylon-12 and Pebax, were examined for their insertion forces via a bench test and a numerical simulation. The simulation built a model identical to the bench test's groove and simulated the balloon's folding process prior to insertion to better replicate the experimental conditions.

Results: In the bench test, nylon-12 demonstrated the highest insertion force, peaking at 0.866 N, significantly outstripping the 0.156 N force exhibited by the Pebax balloon. In the simulation, nylon-12 experienced a higher level of stress after folding, while Pebax had demonstrated a higher effective strain and surface energy density. In terms of insertion force, nylon-12 was higher than Pebax in specific areas.

Conclusion: nylon-12 exerts greater pressure on the vessel wall in curved pathways when compared to Pebax. The simulated insertion forces of nylon-12 align with the experimental results. However, when using the same friction coefficient, the difference in insertion forces between the two materials is minimal. The numerical simulation method used in this study can be used for relevant research. This method can assess the performance of balloons made from diverse materials navigating curved paths and can yield more precise and detailed data feedback compared to benchtop experiments.

Keywords: angioplasty; balloon dilatation catheter; balloon pleating simulation; bench test; finite element analysis; insertion force.

Grants and funding

Key Research Programs of Science & Technology Department of Sichuan Province (23ZDYF1576). National Natural Science Research Foundation of China (12172239).