Hidekazu Takahashi1, Naotsugu Haraguchi1, Junichi Nishimura1, Taishi Hata1, Chu Matsuda1, Hirofumi Yamamoto1, Tsunekazu Mizushima1, Masaki Mori1, Yuichiro Doki1, Kiyokazu Nakajima2,3. 1. Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, 2-2, E-2, Yamadaoka, Suita, Osaka, 565-0871, Japan. 2. Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, 2-2, E-2, Yamadaoka, Suita, Osaka, 565-0871, Japan. knakajima@gesurg.med.osaka-u.ac.jp. 3. Division of Next Generation Endoscopic Intervention (Project ENGINE), Center of Medical Innovation and Translational Research, Global Center for Medical Engineering and Informatics, Osaka University, Suite 0912, 2-2, Yamadaoka, Suita, Osaka, 565-0871, Japan. knakajima@gesurg.med.osaka-u.ac.jp.
Abstract
PURPOSES: Modern electrosurgical tools have a specific coagulation mode called "soft coagulation". However, soft coagulation has not been widely accepted for surgical operations. To optimize the soft coagulation environment, we developed a novel suction device integrated with an electrosurgical probe, called the "Suction ball coagulator" (SBC). In this study, we aimed to optimize the SBC design with a prototyping process involving a bench test and preclinical study; then, we aimed to demonstrate the feasibility, safety, and potential effectiveness of the SBC for laparoscopic surgery in clinical settings. METHODS: SBC prototyping was performed with a bench test. Device optimization was performed in a preclinical study with a domestic swine bleeding model. Then, SBC was tested in a clinical setting during 17 clinical laparoscopic colorectal surgeries. RESULTS: In the bench tests, two tip hole sizes and patterns showed a good suction capacity. The preclinical study indicated the best tip shape for accuracy. In clinical use, no device-related adverse event was observed. Moreover, the SBC was feasible for prompt hemostasis and blunt dissections. In addition, SBC could evacuate vapors generated by tissue ablation using electroprobe during laparoscopic surgery. CONCLUSIONS: We successfully developed a novel, integrated suction/coagulation probe for hemostasis and commercialized it.
PURPOSES: Modern electrosurgical tools have a specific coagulation mode called "soft coagulation". However, soft coagulation has not been widely accepted for surgical operations. To optimize the soft coagulation environment, we developed a novel suction device integrated with an electrosurgical probe, called the "Suction ball coagulator" (SBC). In this study, we aimed to optimize the SBC design with a prototyping process involving a bench test and preclinical study; then, we aimed to demonstrate the feasibility, safety, and potential effectiveness of the SBC for laparoscopic surgery in clinical settings. METHODS: SBC prototyping was performed with a bench test. Device optimization was performed in a preclinical study with a domestic swine bleeding model. Then, SBC was tested in a clinical setting during 17 clinical laparoscopic colorectal surgeries. RESULTS: In the bench tests, two tip hole sizes and patterns showed a good suction capacity. The preclinical study indicated the best tip shape for accuracy. In clinical use, no device-related adverse event was observed. Moreover, the SBC was feasible for prompt hemostasis and blunt dissections. In addition, SBC could evacuate vapors generated by tissue ablation using electroprobe during laparoscopic surgery. CONCLUSIONS: We successfully developed a novel, integrated suction/coagulation probe for hemostasis and commercialized it.
Authors: Alan Moss; Stephen J Williams; Luke F Hourigan; Gregor Brown; William Tam; Rajvinder Singh; Simon Zanati; Nicholas G Burgess; Rebecca Sonson; Karen Byth; Michael J Bourke Journal: Gut Date: 2014-07-01 Impact factor: 23.059
Authors: Nicholas P West; Werner Hohenberger; Klaus Weber; Aristoteles Perrakis; Paul J Finan; Philip Quirke Journal: J Clin Oncol Date: 2009-11-30 Impact factor: 44.544