A Novel Endoscopic Catheter for "laparoscopy-Like" Irrigation and Suction: Its Research and Development Process and Clinical Evaluation

Yasuhiro Miyazaki, Kiyokazu Nakajima, Makoto Hosaka, Namiko Ban, Tsuyoshi Takahashi, Makoto Yamasaki, Hiroshi Miyata, Yukinori Kurokawa, Shuji Takiguchi, Masaki Mori, Yuichiro Doki

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

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 0.4 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. Conclusion: The newly developed EIS catheter is safely used with satisfactory performance in flexible GI endoscopy.

Original languageEnglish
Pages (from-to)943-949
Number of pages7
JournalJournal of Laparoendoscopic and Advanced Surgical Techniques
Volume26
Issue number12
DOIs
Publication statusPublished - Dec 1 2016
Externally publishedYes

Fingerprint

Suction
Laparoscopy
Catheters
Research
Gastrointestinal Endoscopy
Natural Orifice Endoscopic Surgery
Stomach
Swine
Safety
Wounds and Injuries

All Science Journal Classification (ASJC) codes

  • Surgery

Cite this

A Novel Endoscopic Catheter for "laparoscopy-Like" Irrigation and Suction : Its Research and Development Process and Clinical Evaluation. / Miyazaki, Yasuhiro; Nakajima, Kiyokazu; Hosaka, Makoto; Ban, Namiko; Takahashi, Tsuyoshi; Yamasaki, Makoto; Miyata, Hiroshi; Kurokawa, Yukinori; Takiguchi, Shuji; Mori, Masaki; Doki, Yuichiro.

In: Journal of Laparoendoscopic and Advanced Surgical Techniques, Vol. 26, No. 12, 01.12.2016, p. 943-949.

Research output: Contribution to journalArticle

Miyazaki, Y, Nakajima, K, Hosaka, M, Ban, N, Takahashi, T, Yamasaki, M, Miyata, H, Kurokawa, Y, Takiguchi, S, Mori, M & Doki, Y 2016, 'A Novel Endoscopic Catheter for "laparoscopy-Like" Irrigation and Suction: Its Research and Development Process and Clinical Evaluation', Journal of Laparoendoscopic and Advanced Surgical Techniques, vol. 26, no. 12, pp. 943-949. https://doi.org/10.1089/lap.2016.0261
Miyazaki, Yasuhiro ; Nakajima, Kiyokazu ; Hosaka, Makoto ; Ban, Namiko ; Takahashi, Tsuyoshi ; Yamasaki, Makoto ; Miyata, Hiroshi ; Kurokawa, Yukinori ; Takiguchi, Shuji ; Mori, Masaki ; Doki, Yuichiro. / A Novel Endoscopic Catheter for "laparoscopy-Like" Irrigation and Suction : Its Research and Development Process and Clinical Evaluation. In: Journal of Laparoendoscopic and Advanced Surgical Techniques. 2016 ; Vol. 26, No. 12. pp. 943-949.
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AU - Hosaka, Makoto

AU - Ban, Namiko

AU - Takahashi, Tsuyoshi

AU - Yamasaki, Makoto

AU - Miyata, Hiroshi

AU - Kurokawa, Yukinori

AU - Takiguchi, Shuji

AU - Mori, Masaki

AU - Doki, Yuichiro

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