Development of in-vitro fracture durability evaluation system for Mg-alloy bioresorbable stents

• Published in: Transactions of Japanese Society for Medical and Biological Engineering Vol. Annual59; no. Abstract; p. 208
• Main Authors: Ishizuna, Yumi, Yasuda, Yuma, Murakami, Kesuke, Iwasaki, Kiyotaka
• Format: Journal Article
• Language: Japanese
• Published: Japanese Society for Medical and Biological Engineering 2021
• ISSN: 1347-443X; 1881-4379
• DOI: 10.11239/jsmbe.Annual59.208

Bioresorbable Mg-alloy scaffolds expand stenotic lesions and theoretically resolve after lesion healing. In this study, we newly developed a durability test system which simulates biomechanical loads and biochemical fluids conditions in vivo. The Mg-alloy scaffolds were deployed in the elastic artery model which diameter stenosis is 75 %. A two peaked LAD flow waveform with mean flow rate of 60 mL/min and mean coronary artery pressure of 120/80 (100) mmHg was duplicated. Concentrations of chloride ion, proteins, as well as pH in accordance with human blood were duplicated using fetal bovine serum, and using a CO2 gas concentration adjustment device. Our study elucidated that adjustment of pulsatile circulation and radical force by stenotic artery model in a corrosive environment could be essential to conduct reliable in vitro tests. The in-vivo simulated durability tester and test method can be used for pre-clinical evaluation of fracture resistance of bioresorbable magnesium-alloy scaffolds.