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Development of mock circulation systems for the evaluation of innovative medical devices

Research Project

Project/Area Number 15H03041
Research Category

Grant-in-Aid for Scientific Research (B)

Allocation TypeSingle-year Grants
Section一般
Research Field Medical engineering assessment
Research InstitutionWaseda University

Principal Investigator

UMEZU Mitsuo  早稲田大学, 理工学術院, 教授 (90132927)

Co-Investigator(Kenkyū-buntansha) 岩崎 清隆  早稲田大学, 理工学術院, 准教授(任期付) (20339691)
伊関 洋  早稲田大学, 理工学術院, 教授(任期付) (90119892)
八木 高伸  早稲田大学, 理工学術院, 客員主任研究員(研究院客員准教授) (00468852)
松橋 祐輝  早稲田大学, 理工学術院, 助手 (50754777)
Project Period (FY) 2015-04-01 – 2018-03-31
Project Status Completed (Fiscal Year 2017)
Budget Amount *help
¥16,900,000 (Direct Cost: ¥13,000,000、Indirect Cost: ¥3,900,000)
Fiscal Year 2017: ¥3,380,000 (Direct Cost: ¥2,600,000、Indirect Cost: ¥780,000)
Fiscal Year 2016: ¥4,810,000 (Direct Cost: ¥3,700,000、Indirect Cost: ¥1,110,000)
Fiscal Year 2015: ¥8,710,000 (Direct Cost: ¥6,700,000、Indirect Cost: ¥2,010,000)
Keywords医用機械工学 / レギュラトリーサイエンス / 循環シミュレータ / 国産人工弁 / 経皮的大動脈弁 / 生体吸収性ステント / 医療技術評価学 / 医療機器 / 新規治療機器 / 医療技術評価
Outline of Final Research Achievements

The purpose of this study is to develop mock circulation systems for the evaluation of innovative medical devices, which are artificial heart valve, transcatheter aortic valve, and bioresorbable vascular scaffold.
The results of this study will contribute to estimate factors of adverse events and support the planning solutions for the events that are difficult to analyze in the real world.

Report

(4 results)
  • 2017 Annual Research Report   Final Research Report ( PDF )
  • 2016 Annual Research Report
  • 2015 Annual Research Report
  • Research Products

    (45 results)

All 2018 2017 2016 2015

All Journal Article (10 results) (of which Peer Reviewed: 10 results,  Open Access: 3 results) Presentation (35 results) (of which Int'l Joint Research: 8 results,  Invited: 8 results)

  • [Journal Article] Quantitative assessment of paravalvular leakage after transcatheter aortic valve replacement using a patient-specific pulsatile flow model2018

    • Author(s)
      Tanaka Yutaka、Saito Shigeru、Sasuga Saeko、Takahashi Azuma、Aoyama Yusuke、Obama Kazuto、Umezu Mitsuo、Iwasaki Kiyotaka
    • Journal Title

      International Journal of Cardiology

      Volume: 258 Pages: 313-320

    • DOI

      10.1016/j.ijcard.2017.11.106

    • Related Report
      2017 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Real-time visualization of thrombus formation at the interface between connectors and tubes in medical devices by using optical coherence tomography2017

    • Author(s)
      Matsuhashi Yuki、Sameshima Kei、Yamamoto Yoshiki、Umezu Mitsuo、Iwasaki Kiyotaka
    • Journal Title

      PLOS ONE

      Volume: 12 Issue: 12 Pages: 1-13

    • DOI

      10.1371/journal.pone.0188729

    • Related Report
      2017 Annual Research Report
    • Peer Reviewed / Open Access
  • [Journal Article] Time series analysis of the effectiveness and safety of capsule endoscopy between the premarketing and postmarketing settings: A meta-analysis2016

    • Author(s)
      K. Iijima, M. Umezu, K. Iwasaki
    • Journal Title

      PLoS ONE

      Volume: 11 Issue: 6 Pages: 1-14

    • DOI

      10.1371/journal.pone.0153662

    • Related Report
      2016 Annual Research Report
    • Peer Reviewed / Open Access
  • [Journal Article] Analysis of the safety evaluation for premarketing clinical trials of hemodialyzer and of postmarketing safety reports of hemodialyzer in Japan and the US: insights into the construction of a sophisticated premarketing evaluation2016

    • Author(s)
      M.Saito, K.Iwasaki
    • Journal Title

      J Artif Organs

      Volume: 19 Issue: 1 Pages: 1-9

    • DOI

      10.1007/s10047-016-0928-3

    • Related Report
      2016 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Analysis of Medical Device Recalls Owing to Output Information from Software2016

    • Author(s)
      R.Kitawaki, M.Umezu, K.Iwasaki, H.Kasanuki
    • Journal Title

      Regulatory Science of Medical Products

      Volume: 6 Issue: 3 Pages: 281-293

    • DOI

      10.14982/rsmp.6.281

    • NAID

      130005267256

    • ISSN
      2185-7113, 2189-0447
    • Related Report
      2016 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Biomedical engineering analysis to reduce incompletely apposed area yielded by jailed struts after single stenting at left main bifurcation lesions: Micro-CT analysis using a three-dimensional elastic bifurcated coronary artery model2016

    • Author(s)
      Hikichi Y, Umezu M, Node K, Iwasaki K
    • Journal Title

      Cardiovasc Interv and Ther

      Volume: なし Issue: 1 Pages: 12-17

    • DOI

      10.1007/s12928-016-0380-6

    • Related Report
      2016 Annual Research Report 2015 Annual Research Report
    • Peer Reviewed / Open Access
  • [Journal Article] Systematic Analysis of the Incidence of Coronary Stent Fracture and Adverse Events in Japan2016

    • Author(s)
      Y.Matsui, M. Umezu, H.Kasanuki, K.Iwasaki
    • Journal Title

      Regulatory Science of Medical Products

      Volume: 6 Issue: 1 Pages: 1-10

    • DOI

      10.14982/rsmp.6.1

    • NAID

      130005125322

    • ISSN
      2185-7113, 2189-0447
    • Related Report
      2015 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Biomechanical modeling to improve coronary artery bifurcation stenting: Expert review document on techniques and clinical implementation2015

    • Author(s)
      Antoniadis AP, Mortier P, Kassab G, Dubini G, Foin N, Murasato Y, Giannopoulos A, Tu S, Iwasaki K, Hikichi Y, Migliavacca F, Chiastra C, Wentzel J, Gijsen F, H.Reiber J, Barlis P, Serruys PW, Bhatt DL, Stankovic L, Edelman ER, Giannoglou GD, Louvard Y, Chatzizisis YS
    • Journal Title

      JACC: Cardiovascular Interventions

      Volume: 8(10) Issue: 10 Pages: 1281-1296

    • DOI

      10.1016/j.jcin.2015.06.015

    • Related Report
      2015 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Lessons from the real bench: Non-BRS2015

    • Author(s)
      Ormiston J, Darremont O, Iwasaki K, Murasato Y, Hikichi Y, Webber B, Webster M
    • Journal Title

      EuroIntervention: journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology

      Volume: 11 Issue: V Pages: V27-V30

    • DOI

      10.4244/eijv11sva6

    • Related Report
      2015 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Advantages by Vagus Nerve Stimulation Therapy in Patient in Medically Refractory Epilepsy Based on Analysis of Direct Medical Cost of One General Hospital in Japan2015

    • Author(s)
      A.Onomura, T.Yamamoto, H.Iseki, K.Iwasaki, M.Umezu
    • Journal Title

      Regulatory Science of Medical Products

      Volume: 5 Issue: 2 Pages: 111-120

    • DOI

      10.14982/rsmp.5.111

    • NAID

      130005077621

    • ISSN
      2185-7113, 2189-0447
    • Related Report
      2015 Annual Research Report
    • Peer Reviewed
  • [Presentation] 生体吸収性スキャフォールドの耐久性に関する研究:繰返し屈曲角度変化量の影響2017

    • Author(s)
      和泉恒平,水谷泰之、橋本雅也、亀岡洋一郎、高橋啓明,梅津光生、岩﨑清隆
    • Organizer
      日本機械学会第29回バイオエンジニアリング講演会
    • Place of Presentation
      愛知
    • Year and Date
      2017-01-20
    • Related Report
      2016 Annual Research Report
  • [Presentation] 乳頭筋位置が腱索機能を有するステントレス僧帽弁の応力分布に及ぼす影響に関する有限要素解析2017

    • Author(s)
      高田淳平,朱暁冬,臼井一晃,馬原啓太郎,加瀬川均,梅津光生,岩﨑清隆
    • Organizer
      日本機械学会第29回バイオエンジニアリング講演会
    • Place of Presentation
      愛知
    • Year and Date
      2017-01-19
    • Related Report
      2016 Annual Research Report
  • [Presentation] Investigation of an optimal deployment method of polymer BRS to gain acute expansion using a stenotic mechanically-equivalent coronary artery model2017

    • Author(s)
      Y.Mizutani, K.Izumi, X.Zhu, M.Umezu, K.Iwasaki
    • Organizer
      EURO PCR 2017 The World-Leading Course in Interventional Cardiovascular Medicine
    • Related Report
      2017 Annual Research Report
    • Int'l Joint Research
  • [Presentation] Influence of calcification shape around aortic valve annulus on paravalvular leak after TAVI: investigation using patient specific pulsatile circulation model2017

    • Author(s)
      S.Sasuga, Y.Tanaka, K.Obama, A.Takahashi, Y.Aoyama, U.Mitsuo, S.Saito, K.Iwasaki
    • Organizer
      EURO PCR 2017 The World-Leading Course in Interventional Cardiovascular Medicine
    • Related Report
      2017 Annual Research Report
    • Int'l Joint Research
  • [Presentation] Quantification of Incompletely-apposed Gap after Transcatheter Aortic Valve Replacement Using Patient-specific Models for Understanding the Mechanism of Paravalvular Leak2017

    • Author(s)
      S.Sasuga, Y.Tanaka, A.Takahashi, K.Obama, Y.Aoyama, U.Mitsuo, S.Saito, K.Iwasaki
    • Organizer
      22nd Cardovascular summit TCTAP2017
    • Related Report
      2017 Annual Research Report
    • Int'l Joint Research
  • [Presentation] 医療レギュラトリーサイエンスの大学院と研究所の開設による人材育成2017

    • Author(s)
      梅津光生,岩﨑清隆,伊関洋,笠貫宏
    • Organizer
      第55回日本人工臓器学会大会
    • Related Report
      2017 Annual Research Report
  • [Presentation] Normo弁の性能試験:拍動流性能と応力解析2017

    • Author(s)
      高田淳平,加瀬川均,馬原啓太郎,朱暁冬,熊澤亮,梅津光生,岩﨑清隆
    • Organizer
      第6回ステントレス僧帽弁臨床研究学術集会
    • Related Report
      2017 Annual Research Report
  • [Presentation] ステントレス僧帽弁の前・後乳頭筋間距離が弁閉鎖時の応力分布に及ぼす影響の有限要素解析2017

    • Author(s)
      高田淳平,朱暁冬,臼井一晃,馬原啓太郎,加瀬川均,梅津光生,岩﨑清隆
    • Organizer
      日本機械学会関東支部第23期総会・講演会
    • Related Report
      2017 Annual Research Report 2016 Annual Research Report
  • [Presentation] 生体吸収性スキャフォールドの耐久性に関する研究2017

    • Author(s)
      和泉恒平,水谷泰之、橋本雅也、亀岡洋一郎、高橋啓明,梅津光生、岩﨑清隆
    • Organizer
      第29回バイオエンジニアリング講演会
    • Related Report
      2017 Annual Research Report
  • [Presentation] 乳頭筋位置が腱索機能を有するステントレス僧帽弁の応力分布に及ぼす影響に関する有限要素解析2017

    • Author(s)
      高田淳平,朱暁冬,臼井一晃,馬原啓太郎,加瀬川均,梅津光生,岩﨑清隆
    • Organizer
      第29回バイオエンジニアリング講演会
    • Related Report
      2017 Annual Research Report
  • [Presentation] Development of a pulsatile circulatory simulator duplicating movement of mitral annulus and papillary muscles for the assessment of a stentless mitral valve2016

    • Author(s)
      K.Usui,J.Takada, H.Kasegawa, M.Umezu, K.Iwasaki
    • Organizer
      The 16th International Conference on Biomedical Engineering
    • Place of Presentation
      Singapore
    • Year and Date
      2016-12-10
    • Related Report
      2016 Annual Research Report
    • Int'l Joint Research
  • [Presentation] 先進的医療機器開発の迅速化とリスクマネジメントを促進する非臨床評価法の開発意義と展望2016

    • Author(s)
      岩﨑清隆,笠貫宏,梅津光生
    • Organizer
      第54回日本人工臓器学会大会
    • Place of Presentation
      鳥取
    • Year and Date
      2016-11-25
    • Related Report
      2016 Annual Research Report
  • [Presentation] 経カテーテル大動脈弁の弁周囲逆流量評価のための留置前後の弁輪面積を模擬した大動脈弁モデルの開発2016

    • Author(s)
      流石郎子,高橋東,小浜和人,青山祐介,田中穣,齋藤滋,梅津光生,岩﨑清隆
    • Organizer
      日本生体医工学会関東支部若手研究者発表会2016
    • Place of Presentation
      埼玉
    • Year and Date
      2016-11-19
    • Related Report
      2016 Annual Research Report
  • [Presentation] Simulation of Transcatheter Aortic Valve Replacement and Assessment of Regurgitation in in-vitro Pulsatile Model With Patient-specific Anatomy2016

    • Author(s)
      Y.Tanaka, Y.Aoyama, K.Obama, S.Sasuga, A.Takahashi, M.Umezu, S.Saito, K.Iwasaki
    • Organizer
      Scientific Sessions
    • Place of Presentation
      New Orleans
    • Year and Date
      2016-11-14
    • Related Report
      2016 Annual Research Report
  • [Presentation] 冠動脈屈曲変形時にステントに生じる応力解析方法の構築:疲労破断予測に向けて2016

    • Author(s)
      朱暁冬,岩崎清隆,梅津光生
    • Organizer
      非線形解析フォーラム2016
    • Place of Presentation
      東京
    • Year and Date
      2016-11-11
    • Related Report
      2016 Annual Research Report
  • [Presentation] 有限要素法を用いた前後乳頭筋間距離がNormo弁の応力分布に与える影響の評価2016

    • Author(s)
      高田淳平,朱暁冬,臼井一晃,加瀬川均,岩崎清隆,梅津光生
    • Organizer
      非線形解析フォーラム2016
    • Place of Presentation
      東京
    • Year and Date
      2016-11-11
    • Related Report
      2016 Annual Research Report
  • [Presentation] 腱索機能を有するステントレス僧帽弁の評価のための拍動循環シミュレータの開発2016

    • Author(s)
      臼井一晃,高田淳平,加瀬川均,梅津光生,岩﨑清隆
    • Organizer
      第27回バイオフロンティア講演会
    • Place of Presentation
      北海道
    • Year and Date
      2016-10-23
    • Related Report
      2016 Annual Research Report
  • [Presentation] Flow after stenting at left main bifurcation2016

    • Author(s)
      K. Iwasaki, Y. Hikichi
    • Organizer
      European Bifurcation Club meeting
    • Place of Presentation
      Rotterdam
    • Year and Date
      2016-10-14
    • Related Report
      2016 Annual Research Report
    • Int'l Joint Research
  • [Presentation] ヒト左心室モデルを有する拍動循環シミュレータを用いたNormo弁の循環動態に関する研究2016

    • Author(s)
      岩﨑清隆,加瀬川均,臼井一晃,高田淳平,朱暁冬,梅津光生
    • Organizer
      第5回ステントレス僧帽弁臨床研究会学術集会
    • Place of Presentation
      東京
    • Year and Date
      2016-09-11
    • Related Report
      2016 Annual Research Report
  • [Presentation] 自己心膜の採取部位および年齢が力学的特性に与える影響に関する研究2016

    • Author(s)
      井桝浩貴,金一,高梨秀一郎,加瀬川均,岩﨑清隆
    • Organizer
      第5回ステントレス僧帽弁臨床研究会学術集会
    • Place of Presentation
      東京
    • Year and Date
      2016-09-11
    • Related Report
      2016 Annual Research Report
  • [Presentation] 革新的医療機器実用化促進のための非臨床性能評価系と評価法の確立: Engineering Based Medicine2016

    • Author(s)
      岩﨑清隆
    • Organizer
      第6回 レギュラトリーサイエンス学会学術総会
    • Place of Presentation
      東京
    • Year and Date
      2016-09-09
    • Related Report
      2016 Annual Research Report
    • Invited
  • [Presentation] 患者の解剖学的特徴及び病変特性を具備した拍動循環シミュレータによるカテーテル大動脈弁性能評価2016

    • Author(s)
      田中譲,青山祐介,小浜和人,流石朗子,高橋東,梅津光生,齋藤滋,岩﨑清隆
    • Organizer
      第6回レギュラトリーサイエンス学会
    • Place of Presentation
      東京
    • Year and Date
      2016-09-09
    • Related Report
      2016 Annual Research Report
  • [Presentation] 本邦の経皮的大名脈弁植込み術導入期におけるラーニングカーブ2016

    • Author(s)
      山脇理弘,岩﨑清隆,梅津光生,荒木基晴,伊藤努,伊藤良明,多田憲生,高木健督,山中太,渡邉雄介,山本真功,白井伸一,林田健太郎
    • Organizer
      第6回レギュラトリーサイエンス学会
    • Place of Presentation
      東京
    • Year and Date
      2016-09-09
    • Related Report
      2016 Annual Research Report
  • [Presentation] 粒子イメージ流速計測法を用いた経カテーテル大動脈弁の弁周囲逆流の可視化法の開発2016

    • Author(s)
      青山祐介,髙橋東,小浜和人,鈴木砂良,田中穣,齋藤滋,梅津光生,岩﨑清隆
    • Organizer
      第32回ライフサポート学会大会 第16回日本生活支援工学会大会 日本機械学会 福祉工学シンポジウム2016
    • Place of Presentation
      宮城
    • Year and Date
      2016-09-06
    • Related Report
      2016 Annual Research Report
  • [Presentation] 生体吸収性スキャフォールドの分解を伴う経時的な拡張性能試験法の開発2016

    • Author(s)
      高橋啓明,和泉恒平,亀岡洋一郎,梅津光生,岩﨑清隆
    • Organizer
      第32回ライフサポート学会大会 第16回日本生活支援工学会大会 日本機械学会 福祉工学シンポジウム2016
    • Place of Presentation
      宮城
    • Year and Date
      2016-09-06
    • Related Report
      2016 Annual Research Report
  • [Presentation] 冠動脈ステントのプラットフォームの特徴2016

    • Author(s)
      岩﨑清隆
    • Organizer
      第23回日本心血管インターベンション治療学会
    • Place of Presentation
      福岡
    • Year and Date
      2016-08-19
    • Related Report
      2016 Annual Research Report
    • Invited
  • [Presentation] The feature of resolute integrity platform: biomedical engineering analysis2016

    • Author(s)
      岩﨑清隆
    • Organizer
      第2回坂の上PCIビデオライブ
    • Place of Presentation
      愛媛
    • Year and Date
      2016-07-16
    • Related Report
      2016 Annual Research Report
    • Invited
  • [Presentation] 心臓血管外科領域の医療機器・治療法の先進的非臨床評価法の開発2016

    • Author(s)
      岩﨑清隆
    • Organizer
      佐賀大学心臓血管外科同門会
    • Place of Presentation
      佐賀
    • Year and Date
      2016-06-18
    • Related Report
      2016 Annual Research Report
    • Invited
  • [Presentation] 非臨床データの外挿による臨床評価2016

    • Author(s)
      岩﨑清隆
    • Organizer
      レギュラトリーサイエンス エキスパート研修会 専門コース第188回:医療機器第18回,医療機器承認評価とリスクマネジメント
    • Place of Presentation
      東京
    • Year and Date
      2016-04-19
    • Related Report
      2016 Annual Research Report
    • Invited
  • [Presentation] Impact of stent platform: Biomedical Engineering Analysis2016

    • Author(s)
      岩﨑清隆
    • Organizer
      日本心血管インターベンション治療学会(CVIT)第35回東海北陸地方会
    • Place of Presentation
      愛知
    • Year and Date
      2016-04-09
    • Related Report
      2016 Annual Research Report
    • Invited
  • [Presentation] ステントレス僧帽弁(Normo弁)の加速耐久試験方法の開発2016

    • Author(s)
      堀内勇希,岩﨑清隆,臼井一晃,加瀬川均,梅津光生
    • Organizer
      第28回バイオエンジニアリング講演会
    • Place of Presentation
      東京
    • Year and Date
      2016-01-10
    • Related Report
      2015 Annual Research Report
  • [Presentation] 先進的医療機器の迅速な実用化と安全な普及を促進する非臨床評価試験法の開発2015

    • Author(s)
      岩﨑清隆
    • Organizer
      第32回医用高分子研究会講座
    • Place of Presentation
      東京
    • Year and Date
      2015-11-19
    • Related Report
      2015 Annual Research Report
    • Invited
  • [Presentation] Another EBM (Engineering Based Medicine)2015

    • Author(s)
      Umezu M, Iwsaki K, Sakaguchi K, Yagi T, Iseki H, Karube H, Sen I, Kasanuki H
    • Organizer
      Interdisciplinary Cerebrovascular Symposium Intracranial Stent Meeting Program2015
    • Place of Presentation
      Australia
    • Year and Date
      2015-11-13
    • Related Report
      2015 Annual Research Report
    • Int'l Joint Research / Invited
  • [Presentation] Novel insights from flow visualization in the bench2015

    • Author(s)
      K.Iwasaki, Y.Hikichi
    • Organizer
      11th European Bifurcation Club Meeting
    • Place of Presentation
      Athens
    • Year and Date
      2015-09-26
    • Related Report
      2015 Annual Research Report
    • Int'l Joint Research
  • [Presentation] Investigation of influences of flow field in the port of hemofilters on thrombus formation2015

    • Author(s)
      A.Takahashi, K.Iwasaki, S.Suzuki, Y.Aoyama, Y.Matsuhashi, M.Hirata, Y.Yamamotom, M.Umezu
    • Organizer
      15th International Congress of Biorheology and 8th International Conference of Clinical Hemorheology
    • Place of Presentation
      Seoul
    • Year and Date
      2015-05-26
    • Related Report
      2015 Annual Research Report
    • Int'l Joint Research

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Published: 2015-04-16   Modified: 2019-03-29  

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