Novel endoscopic multi-firing-clip applicator for endoscopic closure of large colonic perforations.

BACKGROUND: Existing endoclip closure devices have difficulty in closing large colonic perforation. We developed a novel endoscopic multi-firing-clip applicator (EMFCA) system to address these limitations, and report on its initial evaluation. MATERIAL AND METHODS: The functionality and efficacy of the prototype EMFCA equipped with re-openable clamp and preloaded with four clips were assessed using standardized 1.5 cm incisions created in ex-vivo porcine colonic segments. Endoscopic closure of the lacerations with two, three and four clips (n = five for each group) was followed by measurement of the leakage pressure of the three groups. Finite element analysis (FEA) was performed to validate the clip behavior and reliability during deployment. RESULTS: All 15 perforations were sealed without leakage until fully distended. The leakage pressures of colonic lacerations sealed with two, three, and four clips were 26.1 ± 2.8 mmHg, 37.3 ± 7.3 mmHg and 42.3 ± 7.4 mmHg, respectively. The mean operation time to deploy one clip was 25.4 ± 5.2 seconds. On FEA, the deformation of the shape of the clip matched that of the intended design, with each clip sustaining a maximum stress of 648.5 MPa without any material failure during deployment. CONCLUSIONS: These initial results confirm the efficacy of the EMFCA prototype system for endoscopic closure of colonic perforations.

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

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 4 clips fired successively at a time. Th instrument also equipped with an independent grasper which can be used to clamp target tissues. In order to explor its feasibility and effectiveness of endoluminal closure of gastric perforation, 22 pig stomachs were making a 1 cm 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 (10 mm Hg) for a secure closure. Except 2 cases 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 (P < 0.05) and threshold value. Multiple-clip applier can be served as an effective and safe device to perform the endoluminal closure of gastric perforation.