Miyazaki Yasuhiro, Nakajima Kiyokazu, Hosaka Makoto, Ban Namiko, Takahashi Tsuyoshi, Yamasaki Makoto, Miyata Hiroshi, Kurokawa Yukinori, Takiguchi Shuji, Mori Masaki, Doki Yuichiro
1 Division of Next Generation Endoscopic Intervention (Project ENGINE), Global Center for Medical Engineering and Informatics, Osaka University , Osaka, Japan .
2 Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine , Osaka, Japan .
J Laparoendosc Adv Surg Tech A. 2016 Dec;26(12):943-949. doi: 10.1089/lap.2016.0261. Epub 2016 Jul 18.
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.
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.
Bench tests revealed 0.4 mm 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 500 mL saline with the EIS catheter was significantly shorter than tip irrigation (101 ± 3.1 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.
The newly developed EIS catheter is safely used with satisfactory performance in flexible GI endoscopy.
受自然腔道内镜手术（NOTES）启发，作者开展了新型内镜冲洗吸引（I/S）导管的研发，用于柔性胃肠道（GI）内镜检查中的“类腹腔镜”I/S操作。目的是描述其基础研发过程，并评估其在临床前和临床环境中的性能。
在基础研发阶段，从理论上计算并设计了内镜I/S（EIS）导管顶端喷嘴的侧孔布局。基于强度分析选择喷嘴材料。然后在猪胃中对最终原型EIS导管的性能进行临床前评估，与传统内镜“顶端冲洗”和“顶端吸引”作为对照进行比较。在获得监管许可后，内镜医师对少量患者进行了使用EIS导管进行I/S操作的安全性和可行性的临床评估。
台架试验显示，直径0.4毫米、24个孔、每圆周6 - 8个孔是最合适的侧孔布局，聚醚醚酮是最佳的喷嘴材料。使用EIS导管注入500毫升生理盐水的时间明显短于顶端冲洗（101±3.1秒对154±3.1秒；P <.05）。EIS吸引明显弱于传统内镜顶端吸引，尽管仍在实用范围内。EIS吸引未发现黏膜损伤。在人体使用的临床评估中，未观察到不良事件，内镜医师获得了高度满意度。
新研发的EIS导管在柔性GI内镜检查中使用安全，性能令人满意。
