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Development and commercialization of an ultra compact heparin-free ECMO system for emergency to prolonged use

Research Project

Project/Area Number 17H01594
Research Category

Grant-in-Aid for Scientific Research (A)

Allocation TypeSingle-year Grants
Section一般
Research Field Emergency medicine
Research InstitutionNational Cardiovascular Center Research Institute

Principal Investigator

Tatsumi Eisuke  国立研究開発法人国立循環器病研究センター, オープンイノベーションセンター, 副オープンイノベーションセンター長 (00216996)

Project Period (FY) 2017-04-01 – 2020-03-31
Project Status Completed (Fiscal Year 2019)
Budget Amount *help
¥42,770,000 (Direct Cost: ¥32,900,000、Indirect Cost: ¥9,870,000)
Fiscal Year 2019: ¥13,000,000 (Direct Cost: ¥10,000,000、Indirect Cost: ¥3,000,000)
Fiscal Year 2018: ¥13,650,000 (Direct Cost: ¥10,500,000、Indirect Cost: ¥3,150,000)
Fiscal Year 2017: ¥16,120,000 (Direct Cost: ¥12,400,000、Indirect Cost: ¥3,720,000)
KeywordsECMO / 心肺補助 / ヘパリンフリー / 超小型 / 長期慢性動物試験 / 安全性試験 / 治験開始 / PCPS / 補助循環 / 抗血栓性 / モバイル
Outline of Final Research Achievements

In this study, we have developed a compact durable ECMO system. A disposable blood circuit of this system consists of a novel centrifugal blood pump with hydrodynamic bearings, a compact oxygenator with polymethylpentene membrane and manifold built-in monitors. The entire blood-contacting surface of the circuit was treated with a potent heparin bonding material. A pump motor and measurement instruments were integrated into a driver with extremely compact size and lightweight. The final prototype of the ECMO system was evaluated in various safety tests, basic performance experiments and a series of chronic animal experiments. In the chronic animal experiments, veno-arterial bypass ECMO was conducted in adult goats for up to 4 weeks. ECMO could run for scheduled periods without device exchange in all cases. We carried out the preparations of clinical trial by drawing a protocol and providing education/training. The clinical trial of the ECMO system was started at the final fiscal year.

Academic Significance and Societal Importance of the Research Achievements

本研究の成果として、我々が中心となって開発した長期耐久性と生体適合性に優れる要素技術を一体化したECMOシステムを開発した。本システムは、カセット化された血液回路が駆動装置に搭載されるため、多様なモニタ機能が最小限のケーブルで運用可能で、操作性・携帯性に優れている。世界最小・最軽量を達成した上、1時間のスタンドアローン駆動が可能であるため、安全性・移動性の面からも強い国際競争力が期待できる。本システムの製品化により、緊急時の迅速適用、ヘパリンフリー使用、長期使用などが考えられる。また、急性重症呼吸不全をもたらすウィルス感染症パンデミックに対する有効な生命維持手段として社会的意義も期待できる。

Report

(4 results)
  • 2019 Annual Research Report   Final Research Report ( PDF )
  • 2018 Annual Research Report
  • 2017 Annual Research Report
  • Research Products

    (31 results)

All 2020 2019 2018 2017

All Journal Article (5 results) (of which Peer Reviewed: 4 results,  Open Access: 2 results) Presentation (26 results) (of which Int'l Joint Research: 12 results)

  • [Journal Article] PaO2 greater than 300 mmHg promotes an inflammatory response during extracorporeal circulation in a rat extracorporeal membrane oxygenation model.2020

    • Author(s)
      Fujii Y, Tatsumi E, Nakamura F, Oite T
    • Journal Title

      J Thorac Dis

      Volume: 12 Issue: 3 Pages: 749-757

    • DOI

      10.21037/jtd.2019.12.113

    • Related Report
      2019 Annual Research Report
    • Peer Reviewed / Open Access
  • [Journal Article] Miniaturized centrifugal ventricular assist device for bridge to decision: preclinical chronic study in a bovine model.2019

    • Author(s)
      Shimamura J, Mizuno T, Takewa Y, Tsukiya T, Naito N, Akiyama D, Iiduka K, Katagiri N, Nishimura T, Ono M, Tatsumi E.
    • Journal Title

      Artif Organs.

      Volume: 印刷中 Issue: 9 Pages: 821-827

    • DOI

      10.1111/aor.13459

    • Related Report
      2019 Annual Research Report
    • Peer Reviewed / Open Access
  • [Journal Article] Differences in clotting parameters between species for preclinical large animal studies of cardiovascular devices2018

    • Author(s)
      Mizuno Toshihide、Tsukiya Tomonori、Takewa Yoshiaki、Tatsumi Eisuke
    • Journal Title

      Journal of Artificial Organs

      Volume: 21 Issue: 2 Pages: 138-141

    • DOI

      10.1007/s10047-017-1003-4

    • Related Report
      2018 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Optimal drainage cannula position in dual cannulation for veno-venous extracorporeal membrane oxygenation.2018

    • Author(s)
      Togo K, Takewa Y, Katagiri N, Fujii Y, Yamashita AC, Tastumi E
    • Journal Title

      Int J Artif Organs.

      Volume: 41 Issue: 12 Pages: 867-871

    • DOI

      10.1177/0391398818795357

    • Related Report
      2018 Annual Research Report
    • Peer Reviewed
  • [Journal Article] 呼吸ECMO用のデバイス2017

    • Author(s)
      片桐伸将
    • Journal Title

      人工臓器

      Volume: 46 Pages: 202-207

    • Related Report
      2017 Annual Research Report
  • [Presentation] ディスポーザブル連続流血液ポンプを用いた補助循環システムの適切な評価と体外式VAD/中長期ECMOシステム開発への展開2020

    • Author(s)
      巽 英介
    • Organizer
      医療機器レギュラトリーサイエンス研究会 (21)
    • Related Report
      2019 Annual Research Report
  • [Presentation] Cleavage and re-supply of von Willebrand factor in continuous flow blood pump2019

    • Author(s)
      Mizuno T, Eura Y, Kokame K, Tsukiya T, Takewa Y, Tatsumi E
    • Organizer
      International Society for Heart and Lung Transplantation Annual Meeting and Scientific Sessions (39)
    • Related Report
      2019 Annual Research Report
    • Int'l Joint Research
  • [Presentation] Long-term evaluation of an ultra compact ECMO system with built-in monitors in chronic animal experiments for up to 5 weeks2019

    • Author(s)
      Katagiri N, Takewa Y, Tsukiya T, Mizino T, Shimamura J, Tatsumi E
    • Organizer
      American Society for Artificial Internal Organs (65)
    • Related Report
      2019 Annual Research Report
    • Int'l Joint Research
  • [Presentation] An ultra-compact ECMO system consisting of a novel centrifugal pump with hydrodynamic bearings and its long-term evaluation in animal experiments for up to 5 weeks2019

    • Author(s)
      Katagiri N, Nishinaka T, Takewa Y, Tsukiya T, Mizuno T, Shimamura J, Tatsumi E
    • Organizer
      Annual Meeting of the International Society for Mechanical Circulatory Support (27)
    • Related Report
      2019 Annual Research Report
    • Int'l Joint Research
  • [Presentation] Assessment of safety and effectiveness of the ultracompact extracorporeal membrane oxygenation (ECMO) system (BR13030) use as a long-term cardiopulmonary support for severe heart and/or respiratory failure: Study protocol for multiple-center, single-arm non-randomized, uncontrolled, and investigator-initiated clinical trial2019

    • Author(s)
      Fukushima N, Tatsumi E, Watanabe T, Katagiri N, Takewa Y, Nishinaka T, Hamasaki T, Onda K, Yamamoto H, Hayashi T, Fujita T, Kobayashi J
    • Organizer
      Annual Meeting of the International Society for Mechanical Circulatory Support (27)
    • Related Report
      2019 Annual Research Report
    • Int'l Joint Research
  • [Presentation] Ultra-compact ECMO system consisting with built-in monitors and its long-term evaluation in animal experiments for up to 5 weeks2019

    • Author(s)
      Katagiri N, Nishinaka T, Tsukiya T, Mizuno T, Shimamura J, Takewa Y, Tatsumi E
    • Organizer
      International Federation for Artificial Organs (8)
    • Related Report
      2019 Annual Research Report
    • Int'l Joint Research
  • [Presentation] 多様なモニタを備えた超小型心肺補助システムの慢性動物実験による長期性能評価2019

    • Author(s)
      片桐伸将, 武輪能明. 築谷朋典, 水野敏秀, 島村 淳一, 巽 英介
    • Organizer
      人工心臓と補助循環懇話会学術集会 (47)
    • Related Report
      2019 Annual Research Report
  • [Presentation] 非接触式血液ポンプによる機械的補助循環法の発展2019

    • Author(s)
      築谷朋典, 片桐伸将, 水野敏秀, 武輪能明, 巽 英介
    • Organizer
      日本医工学治療学会学術大会 (35)
    • Related Report
      2019 Annual Research Report 2018 Annual Research Report
  • [Presentation] 優れた抗血栓性と長期耐久性をもつ世界最小・最軽量の次世代型ECMOシステムの開発2019

    • Author(s)
      巽 英介
    • Organizer
      日本経皮的心肺補助研究会 (29)
    • Related Report
      2019 Annual Research Report 2018 Annual Research Report
  • [Presentation] 人工肺ガス流出側の結露防止機能を備えた超小型ECMOシステムの慢性動物実験における評価2019

    • Author(s)
      片桐伸将, 西中知博, 水野敏秀, 築谷朋典, 武輪能明, 巽 英介
    • Organizer
      日本人工臓器学会大会 (57)
    • Related Report
      2019 Annual Research Report
  • [Presentation] 多様なモニタを備えた超小型心肺補助システムの慢性動物実験による長期性能評価2019

    • Author(s)
      片桐伸将, 武輪能明, 築谷朋典, 水野敏秀, 島村 淳一, 巽 英介
    • Organizer
      人工心臓と補助循環懇話会学術集会 (47)
    • Related Report
      2018 Annual Research Report
  • [Presentation] Development of an ultra compact durable ECMO system and evaluation in a chronic animal experiment for 4 weeks2018

    • Author(s)
      Akiyama D, Katagiri N, Iizuka K, Mizuno T, Tsukiya T, Takewa Y, Tatsumi E
    • Organizer
      International Society for Heart and Lung Transplantation Annual Meeting and Scientific Sessions (38)
    • Related Report
      2018 Annual Research Report
    • Int'l Joint Research
  • [Presentation] Differences in fibrin metabolism among the species for preclinical large animal models for cardiovascular devices2018

    • Author(s)
      Mizuno T, Tsukiya T, Takewa Y, Tatsumi E
    • Organizer
      International Society for Heart and Lung Transplantation Annual Meeting and Scientific Sessions (38)
    • Related Report
      2018 Annual Research Report
    • Int'l Joint Research
  • [Presentation] Development of an ultra compact durable ECMO system with built-in monitors and long-term evaluation in chronic animal experiments for 4 weeks2018

    • Author(s)
      Katagiri N, Takewa Y, Tsukiya T, Mizuno T, Takeshita D, Akiyama D, Tatsumi E
    • Organizer
      American Society for Artificial Internal Organs (64)
    • Related Report
      2018 Annual Research Report
    • Int'l Joint Research
  • [Presentation] Development of an ultra compact durable ECMO system with built-in monitors and continuous use evaluation in chronic animal experiments up to 4 weeks2018

    • Author(s)
      Katagiri N, Takewa Y, Tsukiya T, Mizuno T, Tatsumi E
    • Organizer
      Annual European Society for Artificial Organs Congress (45)
    • Related Report
      2018 Annual Research Report
    • Int'l Joint Research
  • [Presentation] Species differences in fibrin metabolism for preclinical animal study for cardiovascular device2018

    • Author(s)
      Mizuno T, Tsukiya T, Takewa Y, Tatsumi E
    • Organizer
      International Society for Mechanical Circulatory Support (26)
    • Related Report
      2018 Annual Research Report
    • Int'l Joint Research
  • [Presentation] Development of a compact ECMO system consisting of a centrifugal pump with hydrodynamic bearings and long-term evaluation in animal experiments2018

    • Author(s)
      Katagiri N, Takewa Y, Tsukiya T, Mizuno T, Tatsumi E
    • Organizer
      International Society for Mechanical Circulatory Support (26)
    • Related Report
      2018 Annual Research Report
    • Int'l Joint Research
  • [Presentation] 多様な内蔵モニタ機能を有する長期耐久性に優れた超小型ECMOシステムの開発と中長期慢性動物実験による評価2018

    • Author(s)
      片桐伸将, 武輪能明, 築谷朋典, 水野敏秀, 竹下大輔, 秋山大地, 巽 英介
    • Organizer
      日本生体医工学会大会 (57)
    • Related Report
      2018 Annual Research Report
  • [Presentation] 多様な内蔵モニタ機能を有する超小型ECMOシステムの開発と4週間を超える慢性動物実験による耐久性と生体適合性の評価2018

    • Author(s)
      片桐伸将, 武輪能明, 築谷朋典, 水野敏秀, 巽 英介
    • Organizer
      日本人工臓器学会大会 (56)
    • Related Report
      2018 Annual Research Report
  • [Presentation] 動物種間における血液凝固特性の違いについて2018

    • Author(s)
      水野敏秀, 築谷朋典, 武輪能明, 巽 英介
    • Organizer
      日本人工臓器学会大会 (56)
    • Related Report
      2018 Annual Research Report
  • [Presentation] Current situation analysis or the reimbursement price of a new medical devices in Japanese insurance system during 2015-20172018

    • Author(s)
      Akagawa E, Tatsumi E
    • Organizer
      European Society for Artificial Organs Congress (45)
    • Related Report
      2018 Annual Research Report
    • Int'l Joint Research
  • [Presentation] 多様な内蔵モニタ機能を有する超小型ECMOシステムの長期耐久性と生体適合性の評価2018

    • Author(s)
      片桐伸将, 武輪能明, 築谷朋典, 水野敏秀, 竹下大輔, 秋山大地, 巽 英介
    • Organizer
      第46回人工心臓と補助循環懇話会学術集会
    • Related Report
      2017 Annual Research Report
  • [Presentation] 多様な内蔵モニタ機能を有する超小型ECMOシステムの長期慢性動物実験による耐久性と生体適合性の評価2018

    • Author(s)
      片桐伸将, 武輪能明, 築谷朋典, 水野敏秀, 竹下大輔, 秋山大地, 巽 英介
    • Organizer
      第28回日本経皮的心肺補助研究会
    • Related Report
      2017 Annual Research Report
  • [Presentation] これからのMCSに必要とされる工学技術について2018

    • Author(s)
      築谷朋典, 水野敏秀, 武輪能明, 片桐伸将, 角田幸秀, 竹下大輔, 飯塚 慶, 秋山大地, 巽 英介
    • Organizer
      第46回人工心臓と補助循環懇話会学術集会
    • Related Report
      2017 Annual Research Report
  • [Presentation] 長期耐久性と携帯性に優れる超小型ECMOシステムの開発と長期生体適合性評価2017

    • Author(s)
      秋山大地, 飯塚 慶, 武輪能明, 巽 英介
    • Organizer
      日本胸部外科学会定期学術集会 (70)
    • Related Report
      2017 Annual Research Report
  • [Presentation] 人工心臓・補助循環装置の開発・実用化と医工連携の推進2017

    • Author(s)
      巽 英介
    • Organizer
      バイオエンジニアリング講演会 (30)
    • Related Report
      2017 Annual Research Report

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Published: 2017-04-28   Modified: 2021-02-19  

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