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

Abstract

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.