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摘要
Background: Inspired by natural orifice translumenal endoscopic surgery (NOTES), the authors launched a development of novel endoscopic irrigation and suction (I/S) catheter for laparoscopy-like I/S in flexible gastrointestinal (GI) endoscopy. The aims were to describe its basic research and development (R&D) process and to estimate its performance in both preclinical and clinical settings. Methods: In basic R&D phase, a layout of side hole at apex nozzle of endoscopic I/S (EIS) catheter were theoretically calculated and designed. Material of nozzle was selected based on the strength analysis. The performance of final prototype EIS catheter was then assessed preclinically in the porcine stomach, to compare with conventional endoscopic tip irrigation and tip suction as control. After regulatory clearance, safety and feasibility of I/S using EIS catheter were clinically assessed by endoscopists in small number of patients. Results: Bench tests revealed 0.4mm in diameter, 24 holes, and 6-8 holes per circumference as most suitable layout of side holes, and polyetheretherketone as an optimal nozzle material, respectively. Time to inject 500mL saline with the EIS catheter was significantly shorter than tip irrigation (1013.1 seconds versus 154 +/- 3.1 seconds; P<.05). The EIS suction was significantly weaker than conventional endoscopic tip suction, though it remained within the practical range. No mucosal injuries were noted in the EIS suction. In clinical assessments for human use, no adverse events were observed, and high degree of satisfaction for endoscopists was obtained. Conclusion: The newly developed EIS catheter is safely used with satisfactory performance in flexible GI endoscopy.
- 出版日期2016-12
