title: A Novel Endoscopic Catheter for "Laparoscopy-Like" Irrigation and Suction: Its Research and Development Process and Clinical Evaluation.
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.
  
  
  CONCLUSIONS
  The newly developed EIS catheter is safely used with satisfactory performance in flexible GI endoscopy.
authors.affiliation: 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 .
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Miyazaki
authors.affiliation: 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 .
authors.forename: Kiyokazu
authors.initials: K
authors.lastname: Nakajima
authors.affiliation: 1 Division of Next Generation Endoscopic Intervention (Project ENGINE), Global Center for Medical Engineering and Informatics, Osaka University , Osaka, Japan .|3 Yamashina Seiki, Co., Ltd. , Ritto, Japan .
authors.forename: Makoto
authors.initials: M
authors.lastname: Hosaka
authors.affiliation: 3 Yamashina Seiki, Co., Ltd. , Ritto, Japan .
authors.forename: Namiko
authors.initials: N
authors.lastname: Ban
authors.affiliation: 2 Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine , Osaka, Japan .
authors.forename: Tsuyoshi
authors.initials: T
authors.lastname: Takahashi
authors.affiliation: 2 Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine , Osaka, Japan .
authors.forename: Makoto
authors.initials: M
authors.lastname: Yamasaki
authors.affiliation: 4 Department of Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases , Osaka, Japan .
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Miyata
authors.affiliation: 2 Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine , Osaka, Japan .
authors.forename: Yukinori
authors.initials: Y
authors.lastname: Kurokawa
authors.affiliation: 2 Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine , Osaka, Japan .
authors.forename: Shuji
authors.initials: S
authors.lastname: Takiguchi
authors.affiliation: 2 Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine , Osaka, Japan .
authors.forename: Masaki
authors.initials: M
authors.lastname: Mori
authors.affiliation: 2 Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine , Osaka, Japan .
authors.forename: Yuichiro
authors.initials: Y
authors.lastname: Doki
mesh_terms: D000818:Animals; D002404:Catheterization; D057785:Catheters; D016099:Endoscopy, Gastrointestinal; D066298:In Vitro Techniques; D010535:Laparoscopy / Q000295:instrumentation; D057605:Natural Orifice Endoscopic Surgery / Q000295:instrumentation*; D013396:Suction / Q000295:instrumentation*; D013552:Swine; D007507:Therapeutic Irrigation / Q000295:instrumentation*
keywords: NOTES; catheter; endoscopy; irrigation; laparoscopy; suction