Development of a wearable, pediatric centrifugal circulatory support system

2013 Fiscal Year Final Research Report

• Project/Area Number: 23300164
• Research Category: Grant-in-Aid for Scientific Research (B)
• Allocation Type: Single-year Grants
• Section: 一般
• Research Field: Biomedical engineering/Biological material science
• Research Institution: Nihon University
• Principal Investigator: TAKATANI Setsuo 日本大学, 医学部, 客員教授 (40154786)
• Co-Investigator(Kenkyū-buntansha): SHIONO Motomi 日本大学, 医学部, 主任教授 (20170847)
• Co-Investigator(Renkei-kenkyūsha): SHINSHI Tadahiko 東京工業大学, 精密工学研究所, 教授 (60272720) ; SAKOTA Daisuke 産業技術総合研究所, ヒューマンライフテクノロジー研究部門, 研究員 (40588670)
• Project Period (FY): 2011-04-01 – 2014-03-31
• Keywords: 人工臓器学

Research Abstract

In this study, we focused upon basic research leading to development of a pediatric circulatory support system. To meet this goal, we have designed a small centrifugal blood pump with a 30mm diameter impeller having 6 straight vanes, supported by a hydrodynamic bearing at its center and driven through outer-radial magnetic coupling to the external motor. The pump diameter measured to be 60mm and its height including the motor to be 30mm, yielding the displaced volume of 85ml and the priming volume of 5ml. The pump provided the flow of 1.0 – 1.5 L/min against the afterload of 100mmHg at the pump speed of 2500 rpm. The pump can be implanted in either extra-corporeally or intra-corporeally inside the thorax from the left ventricular apex to the descending aorta. Because of its small size and extremely small priming volume, it can be used for circulatory support from fetuses, neonates to children bridging to heart transplantation and other more advance therapies.

Research Products

• [Journal Article] New-generation ECMO with MedTech Mag-Lev, a single-use magnetically levitated centrifugal blood pump : Preclinical evaluation in calves (2013)
  • Author(s): Fujiwara T, Nagaoka E, Watanabe T, Miyagi N, Kitao T, Sakota D, Mamiya T, Shinshi T, Arai H, Takatani S
  • Journal Title: Artif Organs Volume: 37(5) Pages: 447-456
  • Peer Reviewed
• [Journal Article] Development of a single-use, extracorporeal magnetically levitated centri- fugal blood pump, MedTech Mag-Lev VAD, for mid- term circulatory support (2013)
  • Author(s): Nagaoka E, Fujiwara T, Kitao T, Sakota D, Shinshi S, Arai H, Takatani S, Arai H, Takatani S
  • Journal Title: ASAIO J Volume: 59 Pages: 246-252
  • Peer Reviewed
• [Journal Article] Fetal cardiac intervention : Improved results of fetal cardiac bypass in immature fetuses using the TinyPump (2013)
  • Author(s): Sebastian VA, Ferro G, Kagawa H, Takatani S, Riemer RK, Hanley FL, Reddy VM
  • Journal Title: The J of Thoracic and Cardiovascular Surgery Volume: 145 Pages: 1460-1464
  • Peer Reviewed
• [Journal Article] Evaluation of platelet aggregability during left ventricular bypass using a MedTech Mag-Lev VAD in a series of chronic calf experiments (2013)
  • Author(s): Kimura T, Yokoyama Y, Sakota D, Nagaoka E, Kitao T, Takakuda K and Takatani S
  • Journal Title: J Artif Organs Volume: 16(1) Pages: 34-41
  • Peer Reviewed
• [Journal Article] Quantitative H-Q線図0501001502002503003500 0.5 1 1.5 2 2.5 3 3.5流量Q[L/min]大動脈圧‐左心内圧の差圧[mmHg] 4500rp m4000rp m3500rp m3000rp m2500rp m2000rp m1500rp m Return Cannula;18Fr Drainage Cannula;22Fr Pump Flow Q (L/min) Head Pressure (Aortic - LVP) (mmHg) Operating Point 100mmHg, 1 L/min with 3000 rpm analysis of optical properties of flowing blood using a photon-cell interactive Monte Carlo code : effects of red blood cells' orientation on light scattering (2012)
  • Author(s): Sakota D and Takatan S
  • Journal Title: J Biomed Optics Volume: 17(5) Pages: 057007:12
  • Peer Reviewed
• [Journal Article] Plasma surface reflectance spectroscopy for noninvasive and continuous monitoring of extracellular component of blood (2012)
  • Author(s): Sakota D and Takatani S
  • Journal Title: Proc SPIE Volume: 8439 Pages: 6
  • Peer Reviewed
• [Journal Article] In vivo evaluation of the TinyPu m p as a pediatric left ventricular assist device (2011)
  • Author(s): Kitao T, Ando Y, Yoshikawa M, Kobayashi M, Kimura T, Ohsawa H, Machida S, Yokoyama N, Sakota D, Konno T, Ishihara K and Takatani S
  • Journal Title: Artif Organs Volume: 35(5) Pages: 543-553
  • Peer Reviewed
• [Journal Article] One-Month Biocompatibility Evaluation of the Pediatric TinyPump in Goats (2011)
  • Author(s): Ando Y, Kitao T, Nagaoka E, Kimura T, Yokoyama Y, Yoshikawa M, Tominaga R and Takatani S
  • Journal Title: Artif Organs Volume: 35(8) Pages: 813-818
  • Peer Reviewed
• [Presentation] hydrodynamically suspended centrifugal TinyPump for short to mid-term circulatory support in pediatric patients (2013)
  • Author(s): Takatani S, Nakata K, Wakui S, Ohsaka S, Abe S, Shinshi T, Hata H and Shiono M. Low prime
  • Organizer: Proceedings of the 21st ISRBP
  • Place of Presentation: Yokohama, Japan
  • Year and Date: 20130926-29
• [Presentation] 体外設置型,連続流補助人工心臓(成人並びに小児用)の研究開発 (2012)
  • Author(s): 高谷節雄, 長岡英気, 藤原立樹, 北尾貴史, 迫田大輔, 土方 亘, 間宮太一, 荒井裕国, 進士忠彦, 安東勇介, 吉川雅治
  • Organizer: 第40回人工心臓と補助循環懇話会学術大会,クアージュ湯布院
  • Place of Presentation: 大分
  • Year and Date: 20120217-18
• [Presentation] 小児用超小型遠心血液ポンプTinyPump の胎児補助循環への応用 (2012)
  • Author(s): 古橋健太, 香川 洋, 藤井泰宏, GiuseppeFerro, R. KirkRiemer, Frank L Hanley, V MohanReddy, 高谷節雄
  • Organizer: 第40回人工心臓と補助循環懇話会学術大会
  • Place of Presentation: クアージュ湯布院, 大分
  • Year and Date: 20120217-18
• [Presentation] 血漿層境界反射分光法による補助循環における血漿の非侵襲連続モニタリング (2012)
  • Author(s): 迫田大輔, 古橋健太, 藤原立樹, 高谷節雄
  • Organizer: 第40回人工心臓と補助循環懇話会学術大会
  • Place of Presentation: クアージュ湯布院, 大分
  • Year and Date: 20120217-18
• [Presentation] 新生児,小児並びに成人用体外設置型,シングルユース遠心式補助人工心臓の研究開発 (2011)
  • Author(s): 高谷節雄, 長岡英気, 北尾貴史, 藤原立樹, 迫田大輔, 間宮太一, 土方 亘, 進士忠彦, 荒井裕国
  • Organizer: 第49回日本人工臓器学会ワークショップ" 製品化を見据えた人工心臓研究開発の最前線"
  • Place of Presentation: 東京
  • Year and Date: 20111125-27