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Surgery Today

, Volume 48, Issue 6, pp 649–655 | Cite as

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

  • Hidekazu Takahashi
  • Naotsugu Haraguchi
  • Junichi Nishimura
  • Taishi Hata
  • Chu Matsuda
  • Hirofumi Yamamoto
  • Tsunekazu Mizushima
  • Masaki Mori
  • Yuichiro Doki
  • Kiyokazu NakajimaEmail author
Original Article

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.

Keywords

Hemostasis Device development Soft coagulation Laparoscopic surgery 

Abbreviations

EMR

Endoscopic mucosal resection

ESD

Endoscopic submucosal dissection

SBC

Suction ball coagulator

PMDA

Pharmaceuticals and medical devices agency

CME

Complete mesocolic excision

TME

Total mesorectal excision

LCS

Laparoscopic coagulation scissors

CO2

Carbon dioxide

CAD

Computer-aided design

IMA

Inferior mesenteric artery

Notes

Acknowledgements

The authors acknowledge AMCO Incorporated, Tokyo, Japan, and Yamashina Seiki Co., Ltd., Siga, Japan, for their technical support.

Compliance with ethical standards

Conflict of interest

Hidekazu Takahashi, Naotsugu Haraguchi, Junichi Nishimura, Taishi Hata, Chu Matsuda, Hirofumi Yamamoto, Tsunekazu Mizushima, Masaki Mori, Yuichiro Doki, and Kiyokazu Nakajima have no conflicts of interest to declare.

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Copyright information

© Springer Nature Singapore Pte Ltd. 2018

Authors and Affiliations

  • Hidekazu Takahashi
    • 1
  • Naotsugu Haraguchi
    • 1
  • Junichi Nishimura
    • 1
  • Taishi Hata
    • 1
  • Chu Matsuda
    • 1
  • Hirofumi Yamamoto
    • 1
  • Tsunekazu Mizushima
    • 1
  • Masaki Mori
    • 1
  • Yuichiro Doki
    • 1
  • Kiyokazu Nakajima
    • 1
    • 2
    Email author
  1. 1.Department of Gastroenterological SurgeryOsaka University Graduate School of MedicineSuitaJapan
  2. 2.Division of Next Generation Endoscopic Intervention (Project ENGINE), Center of Medical Innovation and Translational Research, Global Center for Medical Engineering and InformaticsOsaka UniversitySuitaJapan

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