用于食管内镜黏膜下剥离的磁锚定装置的临床前研究

Preclinical Study of Magnetic Anchoring Device for Endoscopic Esophageal Submucosal Dissection

目的设计加工用于食管内镜黏膜下剥离的磁锚定装置,通过磁力分析探讨其临床应用的可行性。方法测量30例临床患者食管CT影像学数据,体外模拟实验测量食管黏膜剥离中所需的牵拉力,结合磁锚定装置的磁力-位移曲线,分析不同食管平面下磁锚定装置的磁力。结果影像学数据测量显示食管与体表的最大距离为(188.51±10.35)mm,体外模拟实验测试显示食管黏膜下剥离术中需要的牵拉力为0.05 N,实际测量的两种规格磁锚定装置在位移为200 mm时的磁力分别为0.08 N和0.15 N。结论该磁锚定装置的磁力满足食管不同部位的黏膜下剥离术中所需要的牵拉力,能够维持足够组织张力,磁力学可满足临床应用需要。

Objective To design and manufacture a magnetic anchoring device for esophageal endoscopic submucosal dissection,and to explore the feasibility of its clinical application through magnetic analysis.Methods The esophageal CT image data of 30 clinical patients with esophageal cancer were measured,and the traction force required in the esophageal submucosal dissection was measured in vitro simulation experiment.Combined with the magnetic force displacement curve of the magnetic anchoring device,the magnetic force of the magnetic anchoring device under different esophageal planes was analyzed.Results The imaging data showed that the maximum distance between the esophagus and the body surface was(188.51±10.35)mm.The vitro simulation test showed that the traction force required during the esophageal submucosal dissection was 0.05 N,and the actual magnetic force of the two kinds of magnetic anchoring devices with displacement of 200 mm was 0.08 N and 0.15 N respectively.Conclusion The magnetic force of the magnetic anchoring device can meet the traction force needed in the submucosal dissection of different parts of esophagus,and can maintain sufficient tissue tension.The magnetic mechanics can meet the needs of clinical application.