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Development of clinical countermeasures against in-vivo degradation of biomaterials

Research Project

Project/Area Number 16K10879
Research Category

Grant-in-Aid for Scientific Research (C)

Allocation TypeMulti-year Fund
Section一般
Research Field Orthopaedic surgery
Research InstitutionNational Institute of Health Sciences

Principal Investigator

Sakoda Hideyuki  国立医薬品食品衛生研究所, 医療機器部, 主任研究官 (50443099)

Co-Investigator(Kenkyū-buntansha) 菅野 伸彦  大阪大学, 大学院医学系研究科, 寄附講座教授 (70273620)
富田 直秀  京都大学, 工学研究科, 教授 (50263140)
河上 強志  国立医薬品食品衛生研究所, 生活衛生化学部, 室長 (00434043)
Project Period (FY) 2016-04-01 – 2023-03-31
Project Status Completed (Fiscal Year 2022)
Budget Amount *help
¥4,940,000 (Direct Cost: ¥3,800,000、Indirect Cost: ¥1,140,000)
Fiscal Year 2019: ¥650,000 (Direct Cost: ¥500,000、Indirect Cost: ¥150,000)
Fiscal Year 2018: ¥1,300,000 (Direct Cost: ¥1,000,000、Indirect Cost: ¥300,000)
Fiscal Year 2017: ¥1,300,000 (Direct Cost: ¥1,000,000、Indirect Cost: ¥300,000)
Fiscal Year 2016: ¥1,690,000 (Direct Cost: ¥1,300,000、Indirect Cost: ¥390,000)
Keywords人工関節 / 超高分子量ポリエチレン / 生体脂質 / 耐久性 / 生体材料
Outline of Final Research Achievements

A method was developed to quantify the amount of lipids absorbed on ultra-high molecular weight polyethylene components using a Fourier transform infrared spectroscopy.
Quantitative analysis of absorbed lipids and synovial fluids revealed that they contained almost no squalene, which has been used as a model lipid, and cholesterol esters and triglycerides were detected instead.
In vitro model specimens were prepared using these lipids. Mechanical properties of retrieved components and model specimens were evaluated using indentation tests and micro slurry erosion tests. Although the effect of oxidative degradation caused by gamma irradiation on their mechanical properties was detected by these test methods, changes in the mechanical properties thought to be caused by absorbed lipids were not clarified.

Academic Significance and Societal Importance of the Research Achievements

生体内物質による医用材料への影響は、未知の部分が多い。整形外科分野では、人工関節用材料である超高分子量ポリエチレンに対する生体脂質の影響を評価する目的で、生体脂質の一つであるスクアレンを用いた試験法が2022年に規格化された。しかし、本研究の結果、関節液や抜去した材料にスクアレンはほとんど含まれず、抜去した試料を調査してもスクアレンで生じるような劣化は観察されなかった。これらの結果を反映し、より臨床に即した試験法を構築することで、より安全性の高い材料の実用化に貢献できると考えられる。さらに、整形外科分野に限らず、様々なインプラント材料への本研究で得られた知見の展開も期待される。

Report

(8 results)
  • 2022 Annual Research Report   Final Research Report ( PDF )
  • 2021 Research-status Report
  • 2020 Research-status Report
  • 2019 Research-status Report
  • 2018 Research-status Report
  • 2017 Research-status Report
  • 2016 Research-status Report
  • Research Products

    (26 results)

All 2023 2022 2021 2020 2019 2018 2017 2016

All Journal Article (9 results) (of which Peer Reviewed: 9 results,  Acknowledgement Compliant: 1 results) Presentation (17 results) (of which Int'l Joint Research: 5 results,  Invited: 1 results)

  • [Journal Article] 折れ線モデルを用いた球状ポリエチレン粒子の生体反応性評価2021

    • Author(s)
      安田将大,植月啓太,迫田秀行,富田直秀
    • Journal Title

      臨床バイオメカニクス

      Volume: 42 Pages: 239-243

    • NAID

      40022723890

    • Related Report
      2021 Research-status Report
    • Peer Reviewed
  • [Journal Article] 力学特性評価に基づく超高分子量ポリエチレン製コンポーネントの劣化評価2021

    • Author(s)
      迫田秀行,岡本吉弘,菅野伸彦
    • Journal Title

      臨床バイオメカニクス

      Volume: 42 Pages: 245-250

    • NAID

      40022723897

    • Related Report
      2021 Research-status Report
    • Peer Reviewed
  • [Journal Article] In vitro estimation of reduction in strength and wear resistance of UHMWPE for joint prostheses due to lipid-induced degradation.2020

    • Author(s)
      Sakoda H, Okamoto Y and Haishima Y
    • Journal Title

      Journal of biomedical materials research. Part B, Applied biomaterials.

      Volume: 108B Issue: 8 Pages: 3155-3161

    • DOI

      10.1002/jbm.b.34641

    • Related Report
      2020 Research-status Report
    • Peer Reviewed
  • [Journal Article] A novel method to eliminate the influence of absorbed lipids on the characterization of ultra-high molecular weight polyethylene using Fourier-transform infrared spectroscopy.2020

    • Author(s)
      Sakoda H, Sugano N, Okamoto Y and Haishima Y
    • Journal Title

      Bio-medical materials and engineering

      Volume: 31 Issue: 2 Pages: 119-129

    • DOI

      10.3233/bme-201084

    • Related Report
      2020 Research-status Report
    • Peer Reviewed
  • [Journal Article] Method to eliminate the influence of absorbed lipids on the characterization of ultra-high molecular weight polyethylene using Fourier-transform infrared spectroscopy.2020

    • Author(s)
      Sakoda, H., Sugano, N., Okamoto, Y. and Haishima, Y.
    • Journal Title

      Bio-Medical Materials and Engineering (Accepted)

      Volume: -

    • Related Report
      2019 Research-status Report
    • Peer Reviewed
  • [Journal Article] ダイナミック超微小硬度計により測定した超高分子量ポリエチレン製コンポーネント内部の力学特性分布2019

    • Author(s)
      迫田秀行,岡本吉弘,菅野伸彦
    • Journal Title

      臨床バイオメカニクス

      Volume: 40 Pages: 167-170

    • NAID

      40022036747

    • Related Report
      2019 Research-status Report
    • Peer Reviewed
  • [Journal Article] 抜去された親水性表面処理ライナーの表面解析2018

    • Author(s)
      迫田秀行,岡本吉弘,菅野伸彦
    • Journal Title

      臨床バイオメカニクス

      Volume: 39 Pages: 49-53

    • NAID

      40021702721

    • Related Report
      2018 Research-status Report
    • Peer Reviewed
  • [Journal Article] マイクロスラリーエロージョン法を用いた人工関節超高分子量ポリエチレンコンポーネントの劣化評価2017

    • Author(s)
      迫田秀行,岡本吉弘,菅野伸彦
    • Journal Title

      臨床バイオメカニクス

      Volume: 38 Pages: 223-228

    • Related Report
      2017 Research-status Report
    • Peer Reviewed
  • [Journal Article] 抜去した人工関節超高分子量ポリエチレンコンポーネントに含まれる生体脂質の定量2016

    • Author(s)
      迫田秀行,新見伸吾,菅野伸彦
    • Journal Title

      臨床バイオメカニクス

      Volume: 37 Pages: 9-13

    • Related Report
      2016 Research-status Report
    • Peer Reviewed / Acknowledgement Compliant
  • [Presentation] 抜去人工股関節ポリエチレンコンポーネントの分析2023

    • Author(s)
      迫田秀行,岡本吉弘,山本栄一,今釜崇,坂井孝司,濱田英敏,菅野伸彦
    • Organizer
      第53回 日本人工関節学会
    • Related Report
      2022 Annual Research Report
  • [Presentation] Effect of U-shaped motion on in vitro delamination test of UHMWPE for joint prostheses2022

    • Author(s)
      Sakoda H, Okamoto Y, Haishima Y
    • Organizer
      Orthopaedic Research Society, 68th Annual Meeting
    • Related Report
      2021 Research-status Report
    • Int'l Joint Research
  • [Presentation] 抜去人工股関節ライナーの損傷分析2021

    • Author(s)
      迫田秀行,岡本吉弘,蓜島由二,菅野伸彦
    • Organizer
      第51回 日本人工関節学会
    • Related Report
      2021 Research-status Report
  • [Presentation] デラミネーション試験法の検出感度比較2021

    • Author(s)
      迫田秀行,岡本吉弘,蓜島由二
    • Organizer
      第48回 日本臨床バイオメカニクス学会
    • Related Report
      2021 Research-status Report
  • [Presentation] Acceleration effect of the use of higher test load on in vitro delamination test of UHMWPE for joint prostheses.2021

    • Author(s)
      Sakoda H, Okamoto Y and Haishima Y
    • Organizer
      Orthopaedic Research Society, 67th Annual Meeting
    • Related Report
      2020 Research-status Report
  • [Presentation] ダイナミック超微小硬度計で測定した抜去人工股関節超高分子量ポリエチレン製ライナーの材料特性2020

    • Author(s)
      迫田秀行,戸井田瞳,岡本吉弘,蓜島由二,菅野伸彦
    • Organizer
      第50回 日本人工関節学会
    • Related Report
      2020 Research-status Report
  • [Presentation] ダイナミック超微小硬度計により測定した超高分子量ポリエチレン製コンポーネント内部の力学特性分布2020

    • Author(s)
      迫田秀行,岡本吉弘,蓜島由二,菅野伸彦
    • Organizer
      第47回 日本臨床バイオメカニクス学会
    • Related Report
      2020 Research-status Report
  • [Presentation] ダイナミック超微小硬度計で測定した抜去人工股関節超高分子量ポリエチレン製ライナーの材料特性2020

    • Author(s)
      迫田秀行,戸井田瞳,岡本吉弘,蓜島由二,菅野伸彦
    • Organizer
      第50回 日本人工関節学会
    • Related Report
      2019 Research-status Report
  • [Presentation] Surface softening of retrieved ultra-high molecular weight polyethylene components detected by micro indentation tests2019

    • Author(s)
      Sakoda, H., Sugano, N., Okamoto, Y. and Haishima, Y.
    • Organizer
      Orthopaedic Research Society, 65th Annual Meeting
    • Related Report
      2018 Research-status Report
    • Int'l Joint Research
  • [Presentation] 生体脂質による超高分子量ポリエチレンの力学特性への影響の可能性2019

    • Author(s)
      迫田秀行,菅野伸彦,岡本吉弘,蓜島由二
    • Organizer
      第39回 バイオトライボロジシンポジウム
    • Related Report
      2018 Research-status Report
  • [Presentation] ダイナミック超微小硬度計により測定した超高分子量ポリエチレン製コンポーネント内部の力学特性分布2018

    • Author(s)
      迫田秀行,岡本吉弘,蓜島由二,菅野伸彦
    • Organizer
      第45回 日本臨床バイオメカニクス学会
    • Related Report
      2018 Research-status Report
  • [Presentation] Localized degradation at the surface of ultra-high molecular weight polyethylene used for hip prostheses detected by the evaluation of mechanical strength2017

    • Author(s)
      Sakoda H, Okamoto Y, Haishima Y, Sugano N
    • Organizer
      Orthopaedic Research Society, 63rd Annual Meeting
    • Place of Presentation
      San Diego, CA, USA
    • Year and Date
      2017-03-21
    • Related Report
      2016 Research-status Report
    • Int'l Joint Research
  • [Presentation] How can regulatory science support medical applications of the outcome of biotribology2017

    • Author(s)
      Sakoda, H. and Haishima, Y.
    • Organizer
      2nd Czech-Japan Tribology Workshop
    • Related Report
      2017 Research-status Report
    • Int'l Joint Research / Invited
  • [Presentation] 抜去された親水性表面処理ライナーの表面解析2017

    • Author(s)
      迫田秀行,岡本吉弘,蓜島由二,菅野伸彦
    • Organizer
      日本臨床バイオメカニクス学会
    • Related Report
      2017 Research-status Report
  • [Presentation] Methods to evaluate the presence of hydrophilic modification layer on the surface of retrieved acetabular liner2017

    • Author(s)
      Sakoda, H., Okamoto, Y., Haishima, Y. and Sugano, N
    • Organizer
      Orthopaedic Research Society
    • Related Report
      2017 Research-status Report
    • Int'l Joint Research
  • [Presentation] 抜去した超高分子量ポリエチレンコンポーネントに含まれるスクアレンの定量2017

    • Author(s)
      迫田秀行,河上強志,岡本吉弘,蓜島由二,菅野伸彦
    • Organizer
      第47回 日本人工関節学会
    • Place of Presentation
      カルチャーリゾートフィストーネ(宜野湾市)
    • Related Report
      2016 Research-status Report
  • [Presentation] 抜去した人工関節超高分子量ポリエチレンコンポーネントの力学強度分布2016

    • Author(s)
      迫田秀行,岡本吉弘,蓜島由二,菅野伸彦
    • Organizer
      第43回 日本臨床バイオメカニクス学会
    • Place of Presentation
      北海道立道民活動センターかでる2・7(札幌市)
    • Related Report
      2016 Research-status Report

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Published: 2016-04-21   Modified: 2024-01-30  

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