一种软镜用连发施夹器的设计及离体实验研究

Design and In Vitro Experimental Study of an Endoscopic Multiple-clip Applier

设计一种软式内镜用的连发施夹器,以解决现有金属夹产品存在的再定位次数受限、易脱落、单发等问题。本文设计的连发施夹器设有独立抓钳用于抓取、聚拢待夹组织,并可从抓钳内依次施放4个金属夹。为了探究其用于闭合胃穿孔的可行性,本文对22只离体猪胃从外侧做1cm的全层切口,使用连发施夹器闭合(n=12)后测定闭合口爆破压,并与不做处理(n=5)和手工缝合(n=5)的测试结果进行比较,取10mm Hg作为有效闭合的临界值。除2例无效数据外,不做处理组、连发施夹器组和手工缝合组的爆破压值分别为(1.5±0.3)、(46.0±7.1)、(72.5±7.7)mm Hg。实验结果表明,连发施夹器组的爆破压显著大于不做处理组(P<0.05),且高于临界值,能够有效、安全地闭合胃穿孔。

Considering the problems such as reposition limited,easily detached and singly fired of the existing clip products,we developed an endoscopic multiple-clip applier which can apply 4clips fired successively at a time.The instrument also equipped with an independent grasper which can be used to clamp target tissues.In order to explore its feasibility and effectiveness of endoluminal closure of gastric perforation,22 pig stomachs were making a 1cm full-thickness incision from outside and closed by multiple-clip applier（n=12）in vitro.Outcome was measured by bursting pressure and compared with negative control（n=5）and hand suture（n=5）.We set a threshold pressure value（10mm Hg）for a secure closure.Except 2cases of invalid data,the mean bursting pressures of negative control,multiple-clip applier,hand suture were（1.5±0.3）mm Hg,（46.0±7.1）mm Hg,and（72.5±7.7）mm Hg,respectively.The results showed that bursting pressure of multiple-clip applier was significantly higher than that of negative control（P0.05）and threshold value.Multiple-clip applier can be served as an effective and safe device to perform the endoluminal closure of gastric perforation.