Development of new endovascular stent-graft system for type B thoracic aortic dissection with finite element analysis and experimental verification

摘要

Endovascular repair of the thoracic aorta with self-expanding stent-grafts has been emerging as a less invasive alternative treatment compared with conventional open surgeries.Despite the promising efficacy and safety of endovascular stent grafting,the stent-graft failure remains a major concern in terms of stent migration,device fatigue,and the risk of endoleaks.Challenges associated with the stent-grafts involve optimized geometrical structure,lifetime fatigue resistance,and adequate radial support.In this work,a novel endovascular stent-graft system is developed specially for the treatment of Stanford type B thoracic aortic dissections(TAD).Numerical study with finite element analysis(FEA)was utilized to evaluate the mechanical behaviors of the individual stent component.Results of the simulation were validated by experimental tests.Based on the systematic analysis of the parametric variations,a final stent-graft system was developed by the selection and arrangement of the individual stent components,targeting an optimal performance for treatment of TAD.The optimized solution of the stent-graft system was tested in clinical trials,showing advantageous therapeutic efficacy.