Development and commercialization of an ultra compact heparin-free ECMO system for emergency to prolonged use
Project/Area Number |
17H01594
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Research Category |
Grant-in-Aid for Scientific Research (A)
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Allocation Type | Single-year Grants |
Section | 一般 |
Research Field |
Emergency medicine
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Research Institution | National 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)
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Project Period (FY) |
2017-04-01 – 2020-03-31
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Project Status |
Completed (Fiscal Year 2019)
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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)
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Keywords | ECMO / 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.
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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。
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Report
(4 results)
Research Products
(31 results)
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[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.
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Journal Title
Artif Organs.
Volume: 印刷中
Issue: 9
Pages: 821-827
DOI
Related Report
Peer Reviewed / Open Access
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[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
Int'l Joint Research
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