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Development of a Internationally acceptable fatigue test system for prosthetic heart valve

Research Project

Project/Area Number 06557073
Research Category

Grant-in-Aid for Scientific Research (A)

Allocation TypeSingle-year Grants
Section試験
Research Field Thoracic surgery
Research InstitutionWaseda University

Principal Investigator

UMEZU Mitsuo  Dept.of Mechanical Engineering, Waseda University, Professor, 理工学部, 教授 (90132927)

Co-Investigator(Kenkyū-buntansha) NAKANO Kiyoharu  National Cardiovascular Center, 心臓血管外科, 医長 (10138919)
HAYASHI Junichi  Niigata University, School of Medicine, Lectuer, 医学部・付属病院, 講師 (30164940)
KAWAZOE Kohei  Iwate Medical University, School of Medicine, Professor, 外科学第3講座, 教授 (50075561)
TOMIOKA Jun  Dept.of Mechanical Engineering, Waseda University, Associate Professor, 理工学部, 助教授 (40217526)
KAWADA Hiroyuki  Dept.of Mechanical Engineering, Waseda University, Associate Professor, 理工学部, 助教授 (20177702)
川内 義人  国立病院, 九州医療センター, 医長 (80117093)
Project Period (FY) 1994 – 1996
Project Status Completed (Fiscal Year 1996)
Budget Amount *help
¥9,100,000 (Direct Cost: ¥9,100,000)
Fiscal Year 1996: ¥500,000 (Direct Cost: ¥500,000)
Fiscal Year 1995: ¥1,800,000 (Direct Cost: ¥1,800,000)
Fiscal Year 1994: ¥6,800,000 (Direct Cost: ¥6,800,000)
Keywordsheart valve / accelerated fatigue test / durability / Jellyfish valve / creep effect / impact force / FEM analysis / Young's modulus / 耐久試験 / 総負荷 / Jelly-fish弁 / 弁選択基準 / 循環シミュレータ / 僧帽弁 / 人工弁置換
Research Abstract

The purpose of this study is to establish an internationally-acceptable methodology of fatigue testing for prosthetic heart valves, based on the improvement process of a Chinese-made accelerated fatigue test apparatus. This test system had four parallel water cylinders, in which valves were incorporated. Open and closing motion of each valve was controlled at a repetition speed of 10-20 Hz with a displacement of 1-2mm. The Jerryfish (JF) valve was used in this study. It had the longest implantation record in animal trials. In this case, the polyurethane membrane with the thickness of 50-70 mum was ruptured due to a creep effect observed at the middle portion between two spokes after 300days in goat.
First of all, in vitro fatigue test machine has been innovated in order to reproduce the above mentioned in-vivo fatigue test results. Dynamic conditions which enabled the identical forces between accelerated and normal cycles were determined : maximum load during valve closure was 5.2N (inc … More reased by 20% to the normal), and impulse was 2.5*10^<-2>N・s. Under this condition, valves were ruptured for 1.0*10^7 cycles, but no distinct creep was noticed. Secondary, a temperature of the test-fluid was changed from 20゚C to 50゚C,expecting a creep effect to the membrane shape. Change in shape of the membrane was observed after 3.2*10^6 cycles, however, its distortion value was only 50% of the animal experimental results. For the next step, a material of the membrane was changed from polyurethane to polystirene to achieve bigger change in shape. As a result, the identical distortion level was successfully reproduced, but a location of the ruptured area was different between in vitro and in vivo results. In order to clarify the above mentioned difference, FEM analysis was performed. The calculated result exhibited that there are three major areas of the maximum elastic strain between two spokes. Moreover, it was confirmed that the ruptured areas observed by both in vitro/in vivo results could be fully superimposed to the areas of the calculated maximum elastic strain.
Further investigation should by carried out to determine more reliable methodology for fatigue testing, based on the in vitro and FEM analysis data. Less

Report

(4 results)
  • 1996 Annual Research Report   Final Research Report Summary
  • 1995 Annual Research Report
  • 1994 Annual Research Report
  • Research Products

    (26 results)

All Other

All Publications (26 results)

  • [Publications] 梅津光生: "真空成形法による補助人工心臓用人工弁の製作と改良" 人工臓器. 25-1. 43-47 (1996)

    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      1996 Final Research Report Summary
  • [Publications] K.Naemura: "Measurement of the prosthetic valve motion by X-ray high speed video camera" Waseda Int. Cong. of Modeling & Simulation technology for artificial organs. Proc.51-52 (1996)

    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      1996 Final Research Report Summary
  • [Publications] H.Wakui: "Basic hydrodynamic study to establish a fatigue testing method for artificial valves" Waseda Int. Cong. of Modeling & Simulation technology for artificial organs. Proc.62-63 (1996)

    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      1996 Final Research Report Summary
  • [Publications] Y.Shiraishi: "Interactions of the functions between artificial aortic valves and left ventricular pump" Waseda Int. Cong. of Modeling & Simulation technology for artificial organs. Proc.94-95 (1996)

    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      1996 Final Research Report Summary
  • [Publications] K.Izumi: "Hydrodynamic evaluation of different sized prosthetic heart valves" Waseda Int. Cong. of Modeling & Simulation technology for artificial organs. Proc.112-113 (1996)

    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      1996 Final Research Report Summary
  • [Publications] T.Nakayama: "The effects of testing fluids on hydrodynamic characteristics of VAS" Waseda Int. Cong. of Modeling & Simulation technology for artificial organs. Proc.117-118 (1996)

    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      1996 Final Research Report Summary
  • [Publications] K.Naemura: "Measurement of the prosthetic valve motion by X-ray high speed video camera" Waseda Int.Cong.of Modeling & Simulation technology for artificial organs. Proc.51-52 (1996)

    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      1996 Final Research Report Summary
  • [Publications] H.Wakui: "Basic hydrodynamic study to establish a fatigue testing method for artificial valves" Waseda Int.Cong.of Modeling & Simulation technology for artificial organs. Proc.62-63 (1996)

    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      1996 Final Research Report Summary
  • [Publications] Y.Shiraishi: "Interactions of the functions between artificial aortic valves and left ventricular pump" Waseda Int.Cong.of Modeling & Simulation technology for artificial organs. Proc.94-95 (1996)

    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      1996 Final Research Report Summary
  • [Publications] K.Izumi: "Hydrodynamic evaluation of different sized prosthetic heart valves" Waseda Int.Cong.of Modeling & Simulation technology for artificial organs. Proc.112-113 (1996)

    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      1996 Final Research Report Summary
  • [Publications] T.Nakayama: "The effects of testing fluids on hydrodynamic characteristics of VAS" Waseda Int.Cong.of Modeling & Simulation technology for artificial organs. Proc.117-118 (1996)

    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      1996 Final Research Report Summary
  • [Publications] 梅津光生: "真空成形法による補助人工心臓用人工弁の製作と改良" 人工臓器. 25-1. 43-47 (1996)

    • Related Report
      1996 Annual Research Report
  • [Publications] K.Naemura: "Measurement of the prosthetic valve motion by X-ray high speed video camera" Waseda Int.Cong.of Modeling & Simulation technology for artificial organs. Proc.51-52 (1996)

    • Related Report
      1996 Annual Research Report
  • [Publications] H.Wakui: "Basic hydrodynamic study to establish a fatigue testing method for artificial valves" Waseda Int.Cong.of Modeling & Simulation technology for artificial organs. Proc.62-63 (1996)

    • Related Report
      1996 Annual Research Report
  • [Publications] Y.Shiraishi: "Interactions of the functions between artificial aortic valves and left ventricular pump" Waseda Int.Cong.of Modeling & Simulation technology for artificial organs. Proc.94-95 (1996)

    • Related Report
      1996 Annual Research Report
  • [Publications] K.Izumi: "Hydrodynamic evaluation of different sized prosthetic heart valves" Waseda Int.Cong.of Modeling & Simulation technology for artificial organs. Proc.112-113 (1996)

    • Related Report
      1996 Annual Research Report
  • [Publications] T.Nakayama: "The effects of testing fluids on hydrodynamic characteristics of VAS" Waseda Int.Cong.of Modeling & Simulation technology for artificial organs. Proc.117-118 (1996)

    • Related Report
      1996 Annual Research Report
  • [Publications] 中山忠相,小林研二,大沼智之,有田誠,井川彰宏,他: "補助人工心臓の耐久性評価法の検討" 第11回ライフサポート学会大会抄録集. 98 (1995)

    • Related Report
      1995 Annual Research Report
  • [Publications] 苗村潔,正宗賢,鈴木真,土肥健純,松本博志,他: "X線高速ビデオカメラによる人工弁動特性の計測" 第11回ライフサポート学会大会抄録集. 102 (1995)

    • Related Report
      1995 Annual Research Report
  • [Publications] 和久井秀樹,内山賢一,梅津光生,藤本哲男,井街宏他: "心臓代用弁の加速耐久試験法確立のための力学的検討" 第11回ライフサポート学会大会抄録集. 104 (1995)

    • Related Report
      1995 Annual Research Report
  • [Publications] 白石泰之,門田健志,高田淳,藤本哲男,梅津光生: "体循環シミュレータに用いる末梢抵抗器の開発と特性" 第11回ライフサポート学会大会抄録集. 105 (1995)

    • Related Report
      1995 Annual Research Report
  • [Publications] M.Umezu,T.Fujimoto et.al.: "Basic hydrodynamic characteristics of accelerated fatigue test system of prosthetic heart valves" 8th International Confernce on biomedical Engineering,Singapore,Des.7‐10. 213-215 (1994)

    • Related Report
      1994 Annual Research Report
  • [Publications] M.Umezu,T.Fujimoto et.al.: "Development of an Artificial"Hesrt"and"Aorta"in a Mechanical Circulatory System" 8th International Confernce on biomedical Engineering,Singapore,Des.7‐10. 216-218 (1994)

    • Related Report
      1994 Annual Research Report
  • [Publications] M.Umezu,T.Fujimoto et.al.: "Basic Performance of a Miniature Intraventricular Axial pump" 2nd Congress of the International Society for Rotary Blood Pumps,Vienna,Sept.23-25. 210-212 (1994)

    • Related Report
      1994 Annual Research Report
  • [Publications] 藤本哲夫 梅津光生 他: "血液循環系模擬回路における動脈系のインピーダンス測定" 第10回エル・エス・ティ学会大会 姫路. 60 (1994)

    • Related Report
      1994 Annual Research Report
  • [Publications] 苗村潔 梅津光生 他: "左心室拡張期における人工弁特性評価のための機械式モテルの開発" 第10回エル・エス・ティ学会大会 姫路. 55 (1994)

    • Related Report
      1994 Annual Research Report

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Published: 1994-04-01   Modified: 2016-04-21  

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