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TOWARD COMMERCIALIZATION OF TOTALLY IMPLANTABLE, ULTRACOMPACT TOTAL ARTIFICIAL HEART AND VENTRICULAR ASSIST SYSTEMS

Research Project

Project/Area Number 11558102
Research Category

Grant-in-Aid for Scientific Research (B)

Allocation TypeSingle-year Grants
Section展開研究
Research Field Biomedical engineering/Biological material science
Research InstitutionTOKYO MEDICAL AND DENTAL UNIVERSITY

Principal Investigator

TAKATANI Setsuo  TOKYO MEDICAL AND DENTAL UNIVERSITY, INSTITUTE OF BIOMATERIALS AND BIOENGINEERING, PROFESSOR, 生体材料工学研究所, 教授 (40154786)

Co-Investigator(Kenkyū-buntansha) NAKAMURA Makoto  TOKYO MEDICAL AND DENTAL UNIVERSITY, INSTITUTE OF BIOMATERIALS AND BIOENGINEERING, ASS. PROF., 生体材料工学研究所, 助教授 (90301803)
HAMANAKA Hitoshi  TOKYO MEDICAL AND DENTAL UNIVERSITY, INSTITUTE OF BIOMATERIALS AND BIOENGINEERING, PROFESSOR, 生体材料工学研究所, 教授 (10013955)
SAKAMOTO Tohru  TOKYO MEDICAL AND DENTAL UNIVERSITY, GRADUATE SCHOOL OF MEDICINE AND DENTISTRY, PROFESSOR, 大学院・医歯学総合研究科, 教授 (10101875)
KAWAGUCHI Osamu  AICHl MEDICAL COLLEGE, SCHOOL OF MEDICINE, INSTRUCTOR, 医学部, 講師
OHUCHI Katsuhiro  TOKYO MEDICAL AND DENTAL UNIVERSITY, INSTITUTE OF BIOMATERIALS AND BIOENGINEERING, RES ASSOC., 生体材料工学研究所, 助手 (20322084)
村上 泰治  川崎医科大学, 医学部, 助教授 (10142332)
野川 雅道  山形大学, 工学部, 助手 (40292445)
大原 康壽  名古屋大学, 医学部, 医員
Project Period (FY) 1999 – 2000
Project Status Completed (Fiscal Year 2001)
Budget Amount *help
¥13,300,000 (Direct Cost: ¥13,300,000)
Fiscal Year 2000: ¥6,500,000 (Direct Cost: ¥6,500,000)
Fiscal Year 1999: ¥6,800,000 (Direct Cost: ¥6,800,000)
KeywordsElectromechanical TAH / Electromechanical VAD / Heart Transplantation / Continuous Flow Pumps / Centrifugal Blood Pump / Biocompatibility / Durability / Compliance Chamber / Ti-6Al-7Nbチタン合金 / 解剖学的適合性 / 流れの可視化 / モータ駆動全置換型人工心臓 / モータ駆動補助人工心臓 / 循環制御 / エネルギー変換効率 / チタン合金
Research Abstract

In this project, ultracompact, totally implantable total artificial heart (TAH) and ventricular assist system, pulsatile and nonpulsatile, have been developed and their performances were evaluated in vitro and in vivo using calves. The TAH is a one-piece design sandwiching a compact electromechanical actuator between the left and right pusher-plate type blood pumps. The stroke length and stroke volume of the blood pump are 12mm and 55cc. The VAD was designed using the same components as those of TAH by covering the TAH's right side with a back-plate. The dimensions of the TAH are 90mm diameter, 70mm thickness, 400cc volume and 450g weight, while those of the VAD are 90mm, 56mm, 275cc and 460g. The VAD and TAH are much smaller than the currently clinically available systems. (As for performance of the devices, both TAH and VAD generated the maximum flow of 8L/min. The power requirement for VAD ranged from 5 to 8 watts to generate the flow of 4 to 8 L/min against the pump afterload 100mm … More Hg. On the other hand, the TAH required approximately 10 to 15 watts to generate the flowof 4 to 8 L/min against the left and right afterload of 100 and 25mmHg, respectively. The maximum electrical to hydraulic conversion efficiency was 23% for VAD, while for TAH 13.5%. As the associated components for totally implantable system, compliance chamber and rechargeable batteries were also designed and assembled. The displaced volume of the compliance chamber for VAD is 75cc, while for TAH 55cc. The flexing diaphragm of the compliance chamber was made of polyurethane through dip-coating technique.
The anatomical fitting and survival studies with VAD and TAH were performed in one calf for VAD and a total of 6 calves for TAH. As for VAD, the blood was drained from the left ventricular apex and returned to the descending aorta through the VAD. The compliance chamber was implanted in the thoracic cavity and drive line was tunneled underneath the skin to outside the body and connected to the driver. Because of the ventricular fibrillation developed during the surgery, the animal could survive only 24 hours. However, entire implantation procedure has been worked out successfully. Concerning TAH, in the first two calves anatomical fitting study was carried out, followed with TAH implantation in the remaining 4 calves. The heart-lung bypass was performed to excise the native heart, followed with implantation of the TAH. In the last calf # 0107, all the procedure successfully worked out to obtain 30 hour survival with the TAH. The animal was extubated and stood up on his own. The animal was sacrificed 30 hour postoperatively due to reduced left pump flow. Left-right flow balance procedure needs to be improved to better control left and right atrial pressure together with left pump flow. We will continue with in vivo evaluation of the TAH, focusing on durability and biocompatibility aspects, to develop clinically usable totally implantable TAH system.
In addition to pulsatile systems, we also designed and evaluated a single pivot bearing supported centrifugal blood pump. Pump performance, hemolysis test as well as two month durability studies were carried out to evaluate its feasibility as a left ventricular assist device. We will move onto animal study in the next phase.
In order to monitor the patients implanted with artificial heart systems, a reflectance type optical sensor was developed to monitor hemoglobin content and oxygen saturation of the blood inside the artificial heart. Although excellent results have been shown in vitro, animal evaluation must be conducted to evaluate its long term performance in vivo. Less

Report

(3 results)
  • 2001 Final Research Report Summary
  • 2000 Annual Research Report
  • 1999 Annual Research Report
  • Research Products

    (22 results)

All Other

All Publications (22 results)

  • [Publications] Takatani S, Nakamura M, Ohuchi K, Nogawa M, Sakamoto T: "Ultracompact, Completely Implantable Electro-mechanical permanent TAH"Journal of Congestive Heart Failure and Circulatory Support. 1(4). 161-166 (2001)

    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      2001 Final Research Report Summary
  • [Publications] Takatani S, Nakamura M, Ohuchi K, Nogawa M, Sakamoto T: "Ultracompact, Completely Implantable Electro-mechanical pulsatile VAD system"Journal of Congestive Heart Failure and Circulatory Support. 1(4). 161-166 (2001)

    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      2001 Final Research Report Summary
  • [Publications] Nakamura M, Takatani S, Ohuchi K, Sakamoto T, Takatani S et al.: "Oxygen-demand-based physiological control of the total artificial heart"Journal of Congestive Heart Failure and Circulatory Support. 1(4). 201-206 (2001)

    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      2001 Final Research Report Summary
  • [Publications] Ohuchi K, Kikugawa D, Murakami T, Sakamoto T, Takatani S et al.: "Control Strategy For Rotary Blood Pumps"Artif Organs. 25(5). 366-370 (2001)

    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      2001 Final Research Report Summary
  • [Publications] Ohuchi K, Yuhki A, Nakamura M, Sakamoto T, Takatani S: "Development of a compact, seal-less, tri-pod supported centrifugal blood pump"Journal of Congestive Heart Failure and Circulatory Support. 1(4). 413-417 (2001)

    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      2001 Final Research Report Summary
  • [Publications] Ohuchi K, Nakamura M, Sakamoto T, Takatani S et al.: "Automatic control of implantable centrifugal blood pump based on the analysis of motor current waveform"Journal of Congestive Heart Failure and Circulatory Support. 1(4). 431-435 (2001)

    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      2001 Final Research Report Summary
  • [Publications] Takatani S, Nakamura M, Ohuchi K, Nogawa M, Sakamoto T: "Ultracompact, Completely Implantable Electro-mechanical permanent TAH"Journal of Congestive Heart Failure and Circulatory Support. 1(4). 161-166 (2001)

    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      2001 Final Research Report Summary
  • [Publications] Takatani S, Nakamura M, Ohuchi K, Nogawa M, Sakamoto T: "Ultracompact, Conpletely Implantable Electro-mechanical pulsatile VAD system"Journal of Congestive Heart Failure and Circulatory Support. 1(4). 161-166 (2001)

    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      2001 Final Research Report Summary
  • [Publications] Nakamura M, Takatani S, Ohuchi K, Sakamoto T, Honma A, et al: "Oxygen-demand-based physiological control of the total art ificial heart"Journal of Congestive Heart Failure and Circulatory Support. 1(4). 201-206 (2001)

    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      2001 Final Research Report Summary
  • [Publications] Ohuchi K, Kikugawa D,. Murakami T, Sakamoto T, Takatani S et al: "Control Strategy For Rotary Blood Pumps"Artif Organs. 25(5). 366-370 (2001)

    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      2001 Final Research Report Summary
  • [Publications] Ohuchi K, Yuhki A, Nakamura N, Sakamoto T, Takatani S: "Development of a compact, seal-less, trj-pod supported centrifugal blood pump"Journal of Congestive Heart Failure and Circulatory Support. 1(4). 413-417 (2001)

    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      2001 Final Research Report Summary
  • [Publications] Ohuchi K, Nakamura M, Sakamoto T, Takatani S. et al: "Automatics control of implantable centrifugal blood pump based on the analysis of motor current waveform"Journal of Congestive Heart Failure and Circulatory Support. 1(4). 431-435 (2001)

    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      2001 Final Research Report Summary
  • [Publications] 高谷節雄: "学際治療:代替臓器"Heart View. 5(2). 106-114 (2001)

    • Related Report
      2000 Annual Research Report
  • [Publications] Takatani S,Sakamoto T: "Mechanical circulatory support devices for bridge to heart transplantation, bridge to recovery or destination therapy."J Artificial Organs. 3. 75-84 (2000)

    • Related Report
      2000 Annual Research Report
  • [Publications] Takatani S: "Progress of non-pulsatile cardiac assist devices and non-pulsatile physiology."Reports of the Institute of Biomaterials and Bioengineering, Tokyo Medical and Dental University. 34. 14-23 (2000)

    • Related Report
      2000 Annual Research Report
  • [Publications] Yuhki A,Nogawa M,Takatani S: "Development of a compact, seal-less, tripod supported, magnetically driven centrifugal blood pump"Artificial Organs. 24(6). 501-505 (2000)

    • Related Report
      2000 Annual Research Report
  • [Publications] Kaiwa T, Takatani S, et al.: "Measurement of blood hematocrit inside the magnetically suspended centrifugal pump using an opticaltechniqe; Application to assessment of pump flow."Artificial Organs. 23・6. 490-495 (1999)

    • Related Report
      1999 Annual Research Report
  • [Publications] Yuhki A, Takatani S, et al.: "Detection of the suction and regurgitation of the implantable centrifugal pump besed on the motor current waveform analysis and its application to optimization of pump flow"Artificial Organs. 23・6. 532-537 (1999)

    • Related Report
      1999 Annual Research Report
  • [Publications] Kaiwa T, Takatani S, et al.: "Measurement of blood hematocrit inside the magnetically suspended centrifugal pump using an opticaltechniqe; Application to assessment of pump flow."Artificial Organs. 23・3. 253-261 (1999)

    • Related Report
      1999 Annual Research Report
  • [Publications] Kikugawa D, Takatani S, et al.: "Evaluation of an implantable motor driven,permanent use electomechanical VAD."Artificial Organs. 23・3. 249-252 (1999)

    • Related Report
      1999 Annual Research Report
  • [Publications] 海和健史、高谷節雄 他: "磁気浮上型遠心ポンプ内における光学的手法による血液のヘマトクリット測定"人工臓器. 28・1. 173-177 (1999)

    • Related Report
      1999 Annual Research Report
  • [Publications] 本田敦久、高谷節雄 他: "永久使用を目的とした超小型体内完全埋め込み式モータ駆動 VAD 試作とその評価"人工臓器. 28・1. 37-42 (1999)

    • Related Report
      1999 Annual Research Report

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Published: 1999-04-01   Modified: 2016-04-21  

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