Biodegradable high-nitrogen iron alloy anastomotic staples:In vitro and in vivo studies  

作　　者：Sihan Lu Peng Wang Qingchuan Wang Peng Deng Yonghui Yuan Xiaoqing Fu Yinghui Yang Lili Tan Ke Yang Xun Qi 

机构地区：[1]Institute of Metal Research,Chinese Academy of Sciences,Shenyang,110016,China [2]School of Intelligent Medicine,China Medical University,Shenyang,110122,China [3]Department of Interventional Therapy,The First Hospital of China Medical University,Shenyang,110001,China [4]d Department of Surgical Oncology and General Surgery,The First Hospital of China Medical University,Shenyang,110001,China [5]Cancer Hospital of China Medical University,Liaoning Cancer Hospital&Institute,Clinical Research Center for Malignant Tumor of Liaoning Province,Shenyang,110801,China [6]Silvan Medical Device Co.,Ltd.,Suzhou,215004,China [7]g Key Laboratory of Diagnostic Imaging and Interventional Radiology of Liaoning Province,Department of Radiology,The First Hospital of China Medical University,Shenyang,110001,China

出　　处：《Bioactive Materials》2024年第10期34-46,共13页生物活性材料（英文）

基　　金：support from National Natural Science Foundation of China(No.82272099,51971222 and 51801220);Construction Project of Liaoning Medical Imaging and Interventional Medical Engineering Research Center(Grant No.18-006-9-01),STS program(No.20201600200042);DongGuan Innovative Research Team Program(2020607134012);Basic Applied Research Program of Liaoning Province of China(No.2022020347-JH2/1013,2023JH26/103000016).

摘　　要：For gastrointestinal anastomosis,metallic biodegradable staples have a broad application potential.However,both magnesium and zinc alloys have relatively low strength to withstand the repeated peristalsis of the gastrointestinal tract.In this study,we developed a novel kind of biodegradable high-nitrogen iron(HN–Fe)alloy wires(0.23 mm),which were fabricated into the staples.The tensile results showed that the ultimate tensile strength and elongation of HN–Fe wires were 1023.2 MPa and 51.0%,respectively,which was much higher than those of other biodegradable wires.The degradation rate in vitro of HN–Fe wires was slightly higher than that of pure Fe wires.After 28 days of immersion,the tensile strength of HN–Fe wires remained not less than 240 MPa,meeting the clinical requirements.Furthermore,sixteen rabbits were enrolled to conduct a comparison experiment using HN–Fe and clinical Ti staples for gastroanastomosis.After 6 months of implantation,a homogeneous degradation product layer on HN–Fe staples was observed and no fracture occurred.The degradation rate of HN–Fe staples in vivo was significantly higher than that in vitro,and they were expected to be completely degraded in 2 years.Meanwhile,both benign cutting and closure performance of HN–Fe staples ensured that all the animals did not experience hemorrhage and anastomotic fistula during the observation.The anastomosis site healed without histopathological change,inflammatory reaction and abnormal blood routine and biochemistry,demonstrating good biocompatibility of HN–Fe staples.Thereby,the favorable performance makes the HN–Fe staples developed in this work a promising candidate for gastrointestinal anastomosis.

关 键 词：High-nitrogen Iron alloy Surgical staples Mechanical property Degradation 

分 类 号：TG146[一般工业技术—材料科学与工程]