Numerical Methodology to Evaluate Trackability and Pushability of PTCA Balloon Catheter.

PURPOSE: During percutaneous coronary intervention (PCI), the ability to navigate a catheter without causing injury to the vessel and damage to the device is crucial outcome of the procedure. This study aimed to develop a numerical model to analyse the percutaneous transluminal coronary angioplasty (PTCA) catheter navigation in coronary vessels. METHODS: Trackability and pushability are two major parameters used to characterize the navigation of PTCA balloon catheters, and they are influenced by vessel tortuosity, contact interactions and catheter design. In the current study, finite element analysis model is presented to evaluate trackability and pushability considering two different vessel geometries. Impact of contact interactions among catheter, guidewire, and vessel were studied to validate the numerical model with in vitro test data. Further, a parametric study was conducted to understand the influence of distal shaft, and proximal shaft outer diameter. RESULTS: Obtained results suggest that contact interaction and co-efficient of friction between guidewire and catheter are critical parameters to obtain numerical results comparable to experimental data. Results from the parametric study predicted strong positive correlation of distal shaft diameter on pushability, and weak correlation on trackability force. Furthermore, parametric variation in proximal shaft diameter has strong positive correlation on trackability force and strong negative correlation on pushability. CONCLUSION: Numerical methodology presented in this study is a preliminary attempt to simulate the behavior of PTCA balloon catheter navigation. This methodology will be helpful in the design and optimization of PTCA balloon catheter and similar devices with improved deliverability.

Numerical Analysis for Non-Uniformity of Balloon-Expandable Stent Deployment Driven by Dogboning and Foreshortening.

PURPOSE: Stenting is the most common intervention for arteriosclerosis treatment; however, the success of the treatment depends on the incidence of in-stent restenosis (ISR). Stent deployment characteristics are major influencers of ISR and can be measured in terms of dogboning, asymmetry, and foreshortening. This study aimed to analyse the implications of balloon and stent-catheter assembly parameters on the stent deployment characteristics. METHODS: Experimental approach to analyse the impact of the balloon and stent-catheter assembly parameters on stent deployment characteristics is a time-consuming and complex task, whereas numerical methods prove to be quick, efficient, and reliable. In this study, eleven finite element models were employed to analyse non-uniform balloon stent expansion pattern, comprised of variation in, stent axial position on balloon, balloon length, balloon folding pattern, and balloon wall thickness. RESULTS: Obtained results suggest that the axially noncentral position of the stent on balloon and variable balloon thickness lead to non-uniform stent deployment pattern. Also, it was proved that variation in balloon length and balloon folding pattern influence deployment process. CONCLUSION: Improved positional accuracies, uniform balloon wall thickness, and selection of the appropriate length of a balloon for selected stent configuration will help to minimize dogboning, asymmetry, and foreshortening during non-uniform stent expansion, thereby reducing the risk of restenosis. The stated numerical approach will be helpful to optimize stent catheter assembly parameters thus minimizing in-vitro tests and product development time.