Development of a flow path regulating device for an implantable continuous flow artificial heart in cases of an irregular stop and a weaning test

• Project/Area Number: 25560217
• Research Category: Grant-in-Aid for Challenging Exploratory Research
• Allocation Type: Multi-year Fund
• Research Field: Biomedical engineering/Biomaterial science and engineering
• 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, 研究所, 部長 (00216996)
• Co-Investigator(Renkei-kenkyūsha): TAKEWA YOSHIAKI 国立研究開発法人国立循環器病研究センター, 研究所, 室長 (20332405) ; TSUKIYA TOMONORI 国立研究開発法人国立循環器病研究センター, 研究所, 室長 (00311449) ; MIZUNO TOSHIHIDE 国立研究開発法人国立循環器病研究センター, 研究所, 室長 (40426515)
• Project Period (FY): 2013-04-01 – 2016-03-31
• Project Status: Completed (Fiscal Year 2015)
• Budget Amount: ¥3,770,000 (Direct Cost: ¥2,900,000、Indirect Cost: ¥870,000); Fiscal Year 2015: ¥1,430,000 (Direct Cost: ¥1,100,000、Indirect Cost: ¥330,000); Fiscal Year 2014: ¥1,560,000 (Direct Cost: ¥1,200,000、Indirect Cost: ¥360,000); Fiscal Year 2013: ¥780,000 (Direct Cost: ¥600,000、Indirect Cost: ¥180,000)
• Keywords: 流路調節 / 植込み式 / 連続流型 / 補助人工心臓 / 完全遮断 / 小型 / 植込式 / 逆流防止 / 安全性 / 離脱試験 / 心機能評価

Outline of Final Research Achievements

In this study, we tried to develop an implantable flow path regulating device, which preventing backflow at irregular stop and enhancing safety in a weaning test by means of enabling to adjust the flow path of the bypass circuit until shut-off. We employed compact mechanism that demonstrated adequate performance of preventing backflow with left ventricular assist conditions in the water experiment, and promoted the design of the flow path regulating device. Evaluation of this flow path regulating function was conducted by using a heart failure model in an acute animal experiment. It was excluded that prevention of fatal reduction of blood pressure and circulation flow rate during irregular stop of a continuous flow left ventricular assist.

Research Products

• [Journal Article] Influence of a rotational speed modulation system used with an implantable continuous-flow left ventricular assist device (EVAHEART) on von Willebrand factor dynamics (2016)
  • Author(s): Noritsugu Naito, Toshihide Mizuno, Takashi Nishimura, Satoru Kishimoto, Yoshiaki Takewa, Yuka Eura, Koichi Kokame, Toshiyuki Miyata, Kazuma Date, Akihide Umeki, Masahiko Ando, Minoru Ono, and Eisuke Tatsumi
  • Journal Title: Artif. Organs Volume: 未定 Issue: 9 Pages: 877-883
  • DOI: 10.1111/aor.12666
  • Peer Reviewed / Open Access / Acknowledgement Compliant
• [Journal Article] Alternative Approach for Right Ventricular Failure after Left Ventricular Assist Device Placement in Animal Model (2014)
  • Author(s): Tomohiro Saito, Koichi Toda, Yoshiaki Takewa, Tomonori Tsukiya, Toshihide Mizuno, Yoshiyuki Taenaka and Eisuke Tatsumi
  • Journal Title: European journal of cardiothoracic surgery Volume: Oct 7 Issue: 1 Pages: 98-103
  • DOI: 10.1093/ejcts/ezu364
  • Peer Reviewed / Open Access / Acknowledgement Compliant
• [Journal Article] Novel control system to prevent right ventricular failure induced by rotary blood pump (2014)
  • Author(s): Arakawa M, Nishimura T, Takewa Y, Umeki A, Ando M, Kishimoto Y, Fujii Y, Kyo S, Adachi H, Tatsumi E
  • Journal Title: J Artif Organs Volume: 17 Pages: 135-141
  • Peer Reviewed
• [Journal Article] Influence of a novel electrocardiogram-synchronized rotational-speed-change system of an implantable continuous-flow left ventricular assist device (EVAHEART) on hemolytic performance (2014)
  • Author(s): Kishimoto S, Date K, Arakawa M, Takewa Y, Nishimura T, Tsukiya T, Mizuno T, Katagiri N, Kakuta Y, Ogawa D, Nishimura M, Tatsumi E
  • Journal Title: J Artif Organs Volume: 17 Pages: 373-377
  • Peer Reviewed
• [Journal Article] Alternation of left ventricular load by a continuous-flow left ventricular assist device with a native heart load control system in a chronic heart failure model (2014)
  • Author(s): Arakawa MNishimura T, Takewa Y, Umeki A, Ando M, Adachi H, Tatsumi E
  • Journal Title: J Thorac Cardiovasc Surg Volume: 148 Pages: 698-704
  • Peer Reviewed
• [Journal Article] Change of Coronary Flow by Continuous-Flow Left Ventricular Assist Device With Cardiac Beat Synchronizing System (Native Heart Load Control System) in Acute Ischemic Heart Failure Model (2013)
  • Author(s): Nishimura T, Ando M, Takewa Y, Yamazaki K, Kyo S, Ono M, Tsukiya T, Mizuno T, Taenaka Y, Tatsumi E
  • Journal Title: Circulation Journal Volume: 77 Issue: 4 Pages: 995-1000
  • DOI: 10.1253/circj.CJ-12-0676
  • NAID: 10031139003
  • ISSN: 1346-9843, 1347-4820
  • Peer Reviewed
• [Journal Article] Development of a novel drive mode to prevent aortic insufficiency during continuous -flow LVAD support by synchronizing rotational speed with heartbeat (2013)
  • Author(s): Kishimoto Y, Takewa Y, Arakawa M, Umeki A, Ando M, Nishimura T, Fujii Y, Mizuno T, Nishimura M, Tatsumi E
  • Journal Title: J Artif Organs Volume: 16 Pages: 129-137
  • Peer Reviewed
• [Journal Article] Change in myocardial oxygen consumption employing continuous-flow LVAD with cardiac beat synchronizing system, in acute ischemic heart failure models. (2013)
  • Author(s): Umeki A1, Nishimura T, Takewa Y, Ando M, Arakawa M, Kishimoto Y, Tsukiya T, Mizuno T, Kyo S, Ono M, Taenaka Y, Tatsumi E
  • Journal Title: J Artif Organs. Volume: 16(2) Issue: 2 Pages: 119-28
  • DOI: 10.1007/s10047-012-0682-0
  • Peer Reviewed
• [Presentation] 左心補助循環時に大動脈弁逆流が全身血行動態および心代謝へ与える影響に関する研究 (2016)
  • Author(s): 飯塚 慶、内藤敬嗣、水野敏秀、武輪能明、築谷朋典、角田幸秀、片桐伸将、住倉博仁、大沼健太郎、藤井 豊、東郷好美、竹下大輔、巽 英介
  • Organizer: 人工心臓と補助循環懇話会学術集会 (44)
  • Place of Presentation: 宮城郡宮城町
  • Year and Date: 2016-03-04
• [Presentation] 定常流型左室補助人工心臓を用いた自己心拍同期システムの冠血流量の増加効果と左室仕事量の軽減効果 (2015)
  • Author(s): 荒川 衛、西村 隆、武輪能明、梅木昭秀、安藤政彦、岸本祐一郎、岸本 諭、藤井 豊、安達秀雄、巽 英介
  • Organizer: 日本人工臓器学会大会 (53)
  • Place of Presentation: 文京区
  • Year and Date: 2015-11-19
• [Presentation] What is an optimal setting of continuous-flow left ventricular assist device for severe mitral regurgitation? (2015)
  • Author(s): Naito N, Nishimura T, Kishimoto S, Takewa Y, Ono M, Tatsumi E
  • Organizer: American Heart Association Scientific Sessions 2015
  • Place of Presentation: Orlando
  • Year and Date: 2015-11-07
  • Int'l Joint Research
• [Presentation] 定常流型左室補助人工心臓に用いる自己心拍同期回転数制御システムが僧帽弁閉鎖不全症に及ぼす影響 (2015)
  • Author(s): 内藤敬嗣、西村 隆、武輪能明、岸本 諭、伊達数馬、梅木昭秀、安藤政彦、小野 稔、巽 英介
  • Organizer: 日本胸部外科学会定期学術集会 (68)
  • Place of Presentation: 神戸市
  • Year and Date: 2015-10-17
• [Presentation] Preclinical evaluation of the hydrodynamically levitated axial flow blood pump (2015)
  • Author(s): Tsukiya T, Mizuno T, Takewa Y, Tatsumi E, Takewa Y
  • Organizer: Annual Congress of the International Society for Rotary Blood Pump (23)
  • Place of Presentation: Dubrovnik
  • Year and Date: 2015-09-27
  • Int'l Joint Research
• [Presentation] Influence of a rotational speed modulation of an implantable continuous-flow left ventricular assist device (EVAHEART) on von Willebrand's factor dynamics (2015)
  • Author(s): Naito N, Nishimura T, Kishimoto S, Mizuno T, Takewa Y, Ehara-Higuchi Y, Kokame K, Ono M, Tatsumi E
  • Organizer: Annual Congress of the International Society for Rotary Blood Pump (23)
  • Place of Presentation: Dubrovnik
  • Year and Date: 2015-09-27
  • Int'l Joint Research
• [Presentation] 小柄な体格の患者に適用できる補助人工心臓の開発と評価 (2015)
  • Author(s): 築谷朋典、水野敏秀、武輪能明、巽 英介、妙中義之
  • Organizer: 日本機械学会 2015年度年次大会
  • Place of Presentation: 札幌市
  • Year and Date: 2015-09-13
• [Presentation] Control of mitral regurgitation by a continuous-flow left ventricular assist device with a native heart control system (2015)
  • Author(s): Naito N, Nishimura T, Kishimoto S, Takewa Y, Ono M, Tatsumi E
  • Organizer: American Society for Artificial Internal Organs (61)
  • Place of Presentation: Chicago
  • Year and Date: 2015-06-24
  • Int'l Joint Research
• [Presentation] In vitro and in vivo evaluation of the hydrodynamically levitated axial flow pump for a left ventricular assist device (2015)
  • Author(s): Tsukiya T, Mizuno T, Takewa Y, Tatsumi E, Taenaka Y
  • Organizer: American Society for Artificial Internal Organs (61)
  • Place of Presentation: Chicago
  • Year and Date: 2015-06-24
  • Int'l Joint Research
• [Presentation] 定常流型左室補助人工心臓に用いる自己心拍同期回転数制御システムが僧帽弁閉鎖不全症に及ぼす影響 (2015)
  • Author(s): 内藤敬嗣，西村 隆、武輪能明、岸本 諭、伊達数馬、梅木昭秀、安藤政彦、小野 稔、巽 英介
  • Organizer: 人工心臓と補助循環懇話会学術集会 (43)
  • Place of Presentation: 熱海市
  • Year and Date: 2015-02-20 – 2015-02-21
• [Presentation] 非接触軸受による次世代型補助人工心臓の課題 (2014)
  • Author(s): 築谷朋典，水野敏秀、武輪能明、巽 英介、妙中義之
  • Organizer: 日本人工臓器学会大会 (52)
  • Place of Presentation: 札幌市
  • Year and Date: 2014-10-17 – 2014-10-19
• [Presentation] 定常流型左室補助人工心臓に併用する自己心拍同期回転数制御システムが術後慢性期に心拍数に及ぼす影響 (2014)
  • Author(s): 伊達数馬，西村 隆、武輪能明、岸本 諭、荒川 衛、岸本祐一郎、梅木昭秀、安藤政彦、水野敏秀、築谷朋典、小野 稔、巽 英介
  • Organizer: 日本人工臓器学会大会 (52)
  • Place of Presentation: 札幌市
  • Year and Date: 2014-10-17 – 2014-10-19
• [Presentation] 動圧浮上型軸流ポンプを用いた補助人工心臓システムの開発 (2014)
  • Author(s): 築谷朋典，水野敏秀、武輪能明、巽 英介、妙中義之
  • Organizer: 日本定常流ポンプ研究会 2014
  • Place of Presentation: 札幌市
  • Year and Date: 2014-10-17
• [Presentation] アカデミアの医療機器開発－人工臓器部の取り組み (2014)
  • Author(s): 武輪能明，巽 英介
  • Organizer: 日本心不全学会学術集会 (18)
  • Place of Presentation: 大阪市
  • Year and Date: 2014-10-10 – 2014-10-12
• [Presentation] Development of the next-generation mechanical circulatory support systems at NCVC of Japan (2014)
  • Author(s): Tatsumi E
  • Organizer: Joint Cardiovascular Meeting in National Cerebral and Cardiovascular Center and Taiwan Community of Cardiologists (2)
  • Place of Presentation: 吹田市
  • Year and Date: 2014-10-09
• [Presentation] 機械的循環補助に用いられる軸流型血液ポンプ (2014)
  • Author(s): 築谷朋典，巽 英介
  • Organizer: 生体医工学会大会 (53)
  • Place of Presentation: 仙台市
  • Year and Date: 2014-06-24 – 2014-06-26
• [Presentation] The influence of a novel pulsatile driving mode in an implantable continuous flow LVAD (EVAHEART) on hemolytic performance (2014)
  • Author(s): Kishimoto S, Date K, Arakawa M, Takewa Y, Nishimura T, Ogawa D, Tsukiya T, Mizuno T, Katagiri N, Kakuta Y, Nishimura M, Tatsumi E
  • Organizer: American Society for Artificial Internal Organs (60)
  • Place of Presentation: Washington D.C.
  • Year and Date: 2014-06-18 – 2014-06-28
• [Presentation] Miniaturization of an implantable axial-flow ventricular assist device with non-contacting levitation system (2014)
  • Author(s): Tsukiya T, Mizuno T, Takewa Y, Tatsumi E, Taenaka Y
  • Organizer: American Society for Artificial Internal Organs (60)
  • Place of Presentation: Washington D.C.
  • Year and Date: 2014-06-18 – 2014-06-21
• [Presentation] Basic comparison of mechanisms intended for an artificial heart bypass clamp (2014)
  • Author(s): Wieloch R, Katagiri N, Takewa Y., Tatsumi E
  • Organizer: 人工心臓と補助循環懇話会学術集会 (42)
  • Place of Presentation: 湯沢町
• [Presentation] 動圧軸受式遠心血液ポンプの左心補助システムへの応用 (2014)
  • Author(s): 築谷朋典，武輪能明、水野敏秀、住倉博仁、大沼健太郎、東郷好美、藤井 豊、伊達数馬、岸本 諭、熱田祐一、片桐伸将、角田幸秀、Wieloch R、巽 英介、妙中義之
  • Organizer: 人工心臓と補助循環懇話会学術集会 (42)
  • Place of Presentation: 湯沢町
• [Presentation] 小柄患者にも埋込可能な補助人工心臓の開発 (2014)
  • Author(s): 築谷朋典，水野敏秀、武輪能明、巽 英介、丸山 修、西田正浩、星 英男、杉本志郎、妙中義之
  • Organizer: 人工心臓と補助循環懇話会学術集会 (42)
  • Place of Presentation: 湯沢町
• [Presentation] 心拍同期回転数制御システムを利用した定常流型左室補助人工心臓による更なる拍動性獲得を目指して (2014)
  • Author(s): 伊達数馬，西村 隆、荒川 衛、武輪能明、岸本 諭、梅木昭秀、安藤政彦、水野敏秀、築谷朋典、小野 稔、巽 英介
  • Organizer: 人工心臓と補助循環懇話会学術集会 (42)
  • Place of Presentation: 湯沢町
• [Presentation] In vitro performance of an miniaturised axial flow ventricular assist device (2013)
  • Author(s): Tsukiya T, Mizuno T, Hoshi H, Okubo T, Yamane T, Maruyama O, Takewa Y, Tatsumi E
  • Organizer: 日本人工臓器学会大会 (51), International Federation for Artificial Organs (5)
  • Place of Presentation: 横浜市
• [Presentation] The safe program for a newly developed electrocardiogram-synchronized rotational speed control mode with continuous-flow left ventricular assist device (2013)
  • Author(s): Arakawa M, Nishimura T, Takewa Y, Umeki A, Ando M, Kishimoto Y, Kishimoto S, Fujii Y, Kyo S, Adachi H, Tatsumi E
  • Organizer: 日本人工臓器学会大会 (51), International Federation for Artificial Organs (5)
  • Place of Presentation: 横浜市
• [Presentation] Longtime pulsatile control using a rotary blood pump with a newly developed electrocardiogram synchronized rotational speed control system (2013)
  • Author(s): Arakawa M, Nishimura T, Takewa Y, Umeki A, Ando M, Kishimoto Y, Kishimoto S, Yamazaki K, Kyo S, Adachi H, Tatsumi E
  • Organizer: International Society for Rotary Blood Pumps (21)
  • Place of Presentation: Yokohama
• [Presentation] 動圧軸受を応用した長期使用血液ポンプの研究開発 (2013)
  • Author(s): 築谷朋典，巽 英介、妙中義之
  • Organizer: 第91期流体工学部門講演会
  • Place of Presentation: 福岡市