摘要
随着微创手术的普及,尤其是腹腔镜下使用吻合器已成为主流,术中对吻合口的处理面临更大挑战。腔镜视野的局限性使得术中止血和渗漏控制难度增加并延长操作时间,进一步放大了患者创伤风险。为减少吻合口出血、吻合口瘘等并发症,近年来在胃肠道、肺脏等部位应用吻合口加固片,已成为术中对吻合部位加固的新方式。文章从吻合口并发症的类型及危害、吻合口加固片产品申报现状、吻合口加固片产品的常见形状及类型等方面,系统综述了吻合口加固片针对吻合口并发症的应用情况。同时重点探讨该类产品在技术审评中关注的性能指标,对区别于疝修补补片的特殊性能评价进行思考,明确以临床价值为导向的产品相关要求,以期对该类产品的研发生产及监管提供参考。
With the widespread adoption of minimally invasive surgical techniques—particularly the mainstream use of staplers in laparoscopic procedures—intraoperative management of anastomotic sites has become increasingly challenging.The limited field of view in laparoscopic surgery significantly increases the difficulty of hemostasis and leakage control during operations,prolongs procedure time,and further amplifies patients’risk of trauma.To reduce complications such as anastomotic bleeding and leakage,staple line reinforcement materials have emerged in recent years as a novel intraoperative reinforcement method for anastomotic sites in gastrointestinal and pulmonary surgeries.This paper systematically reviews the application of staple line reinforcement materials in addressing anastomotic complications,covering aspects such as the types and risks of anastomotic complications,current regulatory registration status of these products,and their common shapes and classifications.It further focuses on key performance metrics examined during technical evaluations,explores unique performance considerations distinct from hernia repair meshes,and clarifies clinically valuable product requirements.The review aims to provide insights for the research,development,production,and regulatory oversight of such products.
作者
许耘
任英
刘文博
程茂波
XU Yun;REN Ying;LIU Wen-bo;CHENG Mao-bo(Center for Medical Device Evaluation.NMPA,Beijing 100076)
出处
《中国医疗器械信息》
2025年第17期4-6,66,共4页
China Medical Device Information
关键词
吻合口加固片
吻合口出血
吻合口瘘
吻合口撕裂力
吻合口耐压性
staple line reinforcement materials
anastomotic bleeding
anastomotic leakage
anastomotic tensile strength
anastomotic bursting pressure
