Research and clinical translation of trilayer stent-graft of expanded polytetrafluoroethylene for interventional treatment of aortic dissection  

作　　者：Gang Wang Caiyun Gao Benhao Xiao Jie Zhang Xunyuan Jiang Qunsong Wang Jingzhen Guo Deyuan Zhang Jianxiong Liu Yuehui Xie Chang Shu Jiandong Ding 

机构地区：[1]State Key Laboratory of Molecular Engineering of Polymers,Department of Macromolecular Science,Fudan University,Shanghai 200438,China [2]R&D Center,Lifetech Scientific(Shenzhen)Co.,Ltd.,Shenzhen 518057,China [3]Department of Vascular Surgery,the Second Xiangya Hospital of Central South University,Changsha 410011,China [4]State Key Laboratory of Cardiovascular Diseases,Center of Vascular Surgery,Fuwai Hospital,National Center for Cardiovascular Diseases,Chinese Academy of Medical Science and Peking Union Medical College,Beijing 100037,China

出　　处：《Regenerative Biomaterials》2022年第1期650-664,共15页再生生物材料（英文版）

基　　金：financially supported by the National Science Foundation of China(Grant Nos.52130302,21961160721);the National Key R&D Program of China(Grant No.2016YFC1100300).

摘　　要：The aortic dissection(AD)is a life-threatening disease.The transcatheter endovascular aortic repair(EVAR)affords a minimally invasive technique to save the lives of these critical patients,and an appropriate stent-graft gets to be the key medical device during an EVAR procedure.Herein,we report a trilayer stent-graft and corresponding delivery system used for the treatment of the AD disease.The stent-graft is made of nitinol stents with an asymmetric Z-wave design and two expanded polytetrafluoroethylene(ePTFE)membranes.Each of the inner and outer surfaces of the stent-graft was covered by an ePTFE membrane,and the two membranes were then sintered together.The biological studies of the sintered ePTFE membranes indicated that the stent-graft had excellent cytocompatibility and hemocompatibility in vitro.Both the stent-graft and the delivery system exhibited satisfactory mechanical properties and operability.The safety and efficacy of this stent-graft and the corresponding delivery system were demonstrated in vivo.In nine canine experiments,the blood vessels of the animals implanted with the stent-grafts were of good patency,and there were no thrombus and obvious stenosis by angiography after implantation for 6months.Furthermore,all of the nine clinical cases experienced successful implantation using the stent-graft and its postrelease delivery system,and the 1-year follow-ups indicated the preliminary safety and efficacy of the trilayer stent-graft with an asymmetric Z-wave design for interventional treatment.

关 键 词：aortic dissection STENT-GRAFT expanded polytetrafluoroethylene delivery system for interventional treatment clinical translation of biomaterials 

分 类 号：R318[医药卫生—生物医学工程]