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

2021 Fiscal Year Final Research Report

• Project/Area Number: 17K01444
• Research Category: Grant-in-Aid for Scientific Research (C)
• Allocation Type: Multi-year Fund
• Section: 一般
• Research Field: Medical engineering assessment
• Research Institution: National 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
• Keywords: 血管 / ステント / バルーンカテーテル / 圧力

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.

Free Research Field

医工学

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。