A novel suction/coagulation integrated probe for achieving better hemostasis: development and clinical use

作者：Takahashi Hidekazu; Haraguchi Naotsugu; Nishimura Junichi; Hata Taishi; Matsuda Chu; Yamamoto Hirofumi; Mizushima Tsunekazu; Mori Masaki; Doki Yuichiro; Nakajima Kiyokazu^*

来源：Surgery Today, 2018, 48(6): 649-655.

DOI：10.1007/s00595-018-1635-x

• Hemostasis
• Device development
• Soft coagulation
• Laparoscopic surgery

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.
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.
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.
We successfully developed a novel, integrated suction/coagulation probe for hemostasis and commercialized it.

• 出版日期2018-6