中文摘要：

目的 设计一种新型内镜连续止血闭合器械,并进行有限元分析,验证其是否满足实现组织闭合功能的设计要求。方法 在器械抓钳聚拢目标组织后推送金属夹,使其部分穿透组织,通过金属夹与抓钳内壁的相互挤压强迫金属夹细臂弯曲闭合,完成施夹后金属夹留在组织上,并对金属夹施加2 mm反向位移。设定金属夹材料弹性极限为239.0 MPa,抗拉强度为901.0 MPa。结果 在穿刺组织过程中金属夹没有发生变形,最大应力为212.6 MPa;在闭合过程中变形符合设计预期,最大应力为727.7 MPa;在反向2 mm位移下金属夹最大应力为75.8 MPa。金属夹在施夹过程和2 mm位移作用下材料均未失效,最大总应力为741.0 MPa。结论 设计的新型内镜连续止血闭合器械能够一次性施放4个金属夹,具备用于聚拢组织的独立抓钳,能够减少更换金属夹的时间并提高施夹准确性,同时有限元方法验证了器械在使用过程中是安全可靠的。

英文摘要：

Objective To design a novel endoscopic successive hemostasis and closing device, and to validate whether the device can meet the needs of tissue closure by finite element analysis. Methods By using the novel device, the target tissue was clamped and the clip was then pushed to pierce the tissue. Under the compression between the clip and the inner side of the grasper, the thinner arms of the clip were forced to bend and close to stay in the tissue, and then the inverse displacement of 2 mm was applied on the clip. The elastic limit and tensile strength of the clip were set as 239.0 and 901.0 MPa, respectively. Results Deformation did not occur in the piercing process of the clip, with the maximum stress of 212.6 MPa. The deformed shape of the clip in the bending process matched its design expectation, with the maximum stress of 727. 7 MPa. The maximum stress of the clip was 75.8 MPa under 2-mm inverse displacement. Material failure was not found in the bending process or with 2-mm inverse displacement, and the maximum stress in the whole process was 741.0 MPa. Conclusions The novel endoscopic successive hemostasis and closing device proposed in this study can deploy 4 clips at one time, together with an independent grasper for gathering tissues, which can shorten the reloading time and improve the accuracy of clip deployment. The effectiveness and safety of the device is also proved by using finite element method.