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 language | English |
|---|---|
| Pages (from-to) | 943-949 |
| Number of pages | 7 |
| Journal | Journal of Laparoendoscopic and Advanced Surgical Techniques |
| Volume | 26 |
| Issue number | 12 |
| DOIs | |
| Publication status | Published - Dec 1 2016 |
| Externally published | Yes |
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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 journal › Article
}
TY - JOUR
T1 - A Novel Endoscopic Catheter for "laparoscopy-Like" Irrigation and Suction
T2 - Its Research and Development Process and Clinical Evaluation
AU - Miyazaki, Yasuhiro
AU - Nakajima, Kiyokazu
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
PY - 2016/12/1
Y1 - 2016/12/1
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85003707740&partnerID=8YFLogxK
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U2 - 10.1089/lap.2016.0261
DO - 10.1089/lap.2016.0261
M3 - Article
C2 - 27428360
AN - SCOPUS:85003707740
VL - 26
SP - 943
EP - 949
JO - Journal of Laparoendoscopic and Advanced Surgical Techniques - Part A
JF - Journal of Laparoendoscopic and Advanced Surgical Techniques - Part A
SN - 1092-6429
IS - 12
ER -