Enhancing radial strength and expansion uniformity of iron-based vascular scaffolds: a numerical and experimental investigation on topological optimization

提高铁基血管支架的径向强度和扩张均匀性:基于拓扑优化的数值和实验研究

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Abstract

INTRODUCTION: Thin-walled iron-based bioresorbable scaffolds have garnered significant research interest due to their exceptional mechanical properties and favorable biocompatibility. However, current thin-walled iron-based bioresorbable scaffold designs exhibit non-uniform expansion, leading to coating cracking, malapposition, postoperative in-stent restenosis (ISR), and localized pitting corrosion that compromises mechanical integrity. METHODS: This study proposed a dual-factor optimization strategy prioritizing expansion homogeneity through finite element analysis and experimental validation. We systematically modulated the strut width and thickness, as well as the crown radial width in nitrided iron scaffolds, evaluating their mechanical and expansion performance. RESULTS: It showed that the optimized (OPT) scaffold maintained comparable radial recoil and foreshortening to the original design while demonstrating significant reductions in maximum principal strain (19.2%) and equivalent plastic strain of expand (19.0%). DISCUSSION: In vitro expansion experiments confirmed substantially improved expansion homogeneity, while its radial strength (260.07±4.68 kPa) exceeded that of magnesium/polymer scaffolds, achieving parity with CoCr alloy stents. Enhanced expansion homogeneity mitigates coating fracture risks while maintaining clinically sufficient support.

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