Shinsuke Katsuyama, MD1, Tsuyoshi Takahashi, MD, PhD2, Yasunori Miyazaki, MD, PhD2, Tomoki Makino, MD, PhD2, Yukinori Kurokawa, MD, PhD, FACS2, Makoto Miyasaki, MD, PhD2, Shuji Takiguchi, MD, PhD2, Masaki Mori, MD, PhD, FACS2, Yuichiro Doki, MD, PhD2, Kiyokazu Nakajima, MD, PhD, FACS1. 1Division of Next Generation Endoscopic Intervention, Osaka University, 2Department of Gastroenterological Surgery, Osaka University
Background: The role of laparoscopic instruments less than Ø5mm, i.e. needlescopic or miniature instruments, has been increasing in the era of single-incision, needlescopic and/or reduce port surgery. A wide variety of miniature instruments has already been commercially available, however, a cotton dissector has not been down-sized yet, partially due to high manufacturing barriers. We have successfully developed a novel Ø3mm cotton dissector, in collaboration with an industry which has promising manufacturing technology for downsizing cotton swabs: spraying cotton powders and molding them with biocompatible glue on a shaft, instead of whipping cotton strings directly onto a shaft. The aims of this study were to evaluate safety and performance of this newly developed miniature cotton dissector in bench-top testing and preclinical settings.
Methods: [Safety study] The stability of “sprayed and glued” cotton powders was evaluated in a standard “elution test” (n=5): counting number of cotton particles > 0.5μm eluted out from cotton bud soaked in 500 mL pure water for 10 minutes and centrifuged @ 150 rpm. Commercially available two Ø5mm cotton dissectors (dissectors A and B) were served as control (n=5 each). [Performance study] The Ø3mm cotton dissector was used in porcine laparoscopic surgery to evaluate its performance. Results: [Safety study] The median number of cotton particles eluted out from new Ø3mm cotton dissector was 175 in pure water, whereas 329X102 out from dissector A, and 312X102 out from dissector B, respectively. [Performance study] The new Ø3mm cotton dissector performed well in porcine laparoscopic fundoplication, especially in blunt dissection of retro-esophageal spaces. Although no organ injuries directly related to the use of cotton dissectors were encountered, additional care might be required since the tip of “needlescopic” dissector showed easier penetration into parenchymal organs e.g. liver and spleen.
Conclusions: Our newly developed Ø3mm cotton dissector is far more stable in its physical property when compared to currently existing Ø5mm equivalent products. Its performance is considered acceptable, as long as used by expertized hands with firm understanding of potential risk of ultra-thin instruments. The devices are now under regulatory process in Japan and will become clinically available soon.
Presented at the SAGES 2017 Annual Meeting in Houston, TX.
Abstract ID: 79333
Program Number: P658
Presentation Session: Poster (Non CME)
Presentation Type: Poster