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Development of efficient nonclinical evaluation system for innovative medical equipment flow diverte

Research Project

Project/Area Number 17K01444
Research Category

Grant-in-Aid for Scientific Research (C)

Allocation TypeMulti-year Fund
Section一般
Research Field Medical engineering assessment
Research InstitutionNational Institute of Health Sciences

Principal Investigator

OKAMOTO YOSHIHIRO  国立医薬品食品衛生研究所, 医療機器部, 室長 (40776027)

Co-Investigator(Kenkyū-buntansha) 中村 匡徳  名古屋工業大学, 工学(系)研究科(研究院), 教授 (20448046)
太田 信  東北大学, 流体科学研究所, 教授 (20400418)
Project Period (FY) 2017-04-01 – 2022-03-31
Project Status Completed (Fiscal Year 2021)
Budget Amount *help
¥4,680,000 (Direct Cost: ¥3,600,000、Indirect Cost: ¥1,080,000)
Fiscal Year 2019: ¥1,430,000 (Direct Cost: ¥1,100,000、Indirect Cost: ¥330,000)
Fiscal Year 2018: ¥1,430,000 (Direct Cost: ¥1,100,000、Indirect Cost: ¥330,000)
Fiscal Year 2017: ¥1,820,000 (Direct Cost: ¥1,400,000、Indirect Cost: ¥420,000)
Keywords血管 / ステント / バルーンカテーテル / 圧力 / 血管モデル / フローダイバーター / 形状予測 / 留置後形状 / 医療・福祉 / 医療機器評価 / レギュラトリーサイエンス
Outline of Final Research Achievements

The shape of the flow diverters when implanted was evaluated, and it was found that the change in vessel shape before and after implantation was minimal.The objective was to predict post-implantation shape, but due to the difficulty of obtaining the device, the objective was changed to evaluating the pressure load on the vessel when the intravascular device is used.
The basic characteristics of semi-compliant and compliant balloons during balloon catheter dilation were evaluated.
We constructed an evaluation system to measure the relationship between the internal pressure of the balloon and the pressure applied to the blood vessel, and succeeded in clarifying the relationship between the internal pressure of the balloon and the pressure applied to the blood vessel, which had not been understood until now.

Academic Significance and Societal Importance of the Research Achievements

血管内治療用のデバイスの血管内での留置、使用時における血管形状の変形および血管へかかる圧力負荷について評価を実施した。バルーンカテーテルから血管へかかる圧力負荷については、今までの研究では、血管へかかる圧力負荷を正確に評価されたものは少なく、バルーン内圧と血管への圧力を定量的に評価することに成功した。バルーン内圧と拡張血管径の関係からバルーンから血管へかかる圧力負荷を把握することが可能となり、今後、圧力負荷と血管損傷等の関係が明らかになれば、バルーンカテーテルの種類、サイズ選択等の適正選択に貢献し、臨床成績の向上に役立つはずである。

Report

(6 results)
  • 2021 Annual Research Report   Final Research Report ( PDF )
  • 2020 Research-status Report
  • 2019 Research-status Report
  • 2018 Research-status Report
  • 2017 Research-status Report
  • Research Products

    (6 results)

All 2022 2021 2020 2018

All Journal Article (1 results) (of which Peer Reviewed: 1 results,  Open Access: 1 results) Presentation (5 results) (of which Int'l Joint Research: 1 results)

  • [Journal Article] In Vitro Measurement of Contact Pressure Applied to a Model Vessel Wall during Balloon Dilation by Using a Film-Type Sensor2022

    • Author(s)
      Moriwaki Takeshi、Okamoto Yoshihiro、Yamaga Hiroo、Fujisaki Kazuhiro、Uematsu Miyuki、Sakoda Hideyuki、Haishima Yuji
    • Journal Title

      Journal of Neuroendovascular Therapy

      Volume: 16 Issue: 4 Pages: 192-197

    • DOI

      10.5797/jnet.oa.2021-0068

    • NAID

      130008081044

    • ISSN
      1882-4072, 2186-2494
    • Related Report
      2021 Annual Research Report
    • Peer Reviewed / Open Access
  • [Presentation] バルーンカテーテルから血管が受ける圧力に関する基礎的検討2021

    • Author(s)
      岡本吉弘,森脇健司,植松美幸,迫田秀行,蓜島由二
    • Organizer
      第59回日本人工臓器学会大会
    • Related Report
      2021 Annual Research Report
  • [Presentation] Quantitative Evaluation of Contact Pressure during Balloon Catheter Dilation by Using a Flexible Film Sensor2021

    • Author(s)
      Takeshi MORIWAKI,Yoshihiro OKAMOTO,Kazuhiro FUJISAKI,Hiroo YAMAGA
    • Organizer
      The 11th Asian-Pacific Conference on Biomechanics
    • Related Report
      2021 Annual Research Report
    • Int'l Joint Research
  • [Presentation] バルーンカテーテルから血管が受ける接触圧力に関する実験的検証2020

    • Author(s)
      岡本吉弘,森脇健司,山家弘雄, 植松美幸,迫田秀行,蓜島由二
    • Organizer
      第36回日本脳神経血管内治療学会学術総会
    • Related Report
      2020 Research-status Report
  • [Presentation] バルーンカテーテル拡張時に血管モデル内壁に作用する接触圧力の計測:血管壁の弾性率の影響2020

    • Author(s)
      森脇健司,岡本吉弘,藤﨑和弘
    • Organizer
      第58回日本人工臓器学会大会
    • Related Report
      2020 Research-status Report
  • [Presentation] Pre-operative FD deployment experiment using a PVA-H model2018

    • Author(s)
      Simon Tupin, Shin-Ichiro Sugiyama, Kaihong Yu, Yasutomo Shimizu, Takanobu Yagi, Yoshihiro Okamoto, Yasushi Matsumoto, Makoto Ohta
    • Organizer
      34th Annual Meeting of The Japanese Society for Neuroendovascular Therapy (JSNET)
    • Related Report
      2018 Research-status Report

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Published: 2017-04-28   Modified: 2023-01-30  

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