成果報告書詳細
管理番号20110000001714
タイトル*平成22年度中間年報「基礎研究から臨床研究への橋渡し促進技術開発/橋渡し促進技術開発/次世代型高機能血液ポンプシステムの研究開発」(独立行政法人産業技術総合研究所)
公開日2012/10/4
報告書年度2010 - 2010
委託先名独立行政法人産業技術総合研究所
プロジェクト番号P07022
部署名バイオテクノロジー・医療技術部
和文要約和文要約等以下本編抜粋:
1. 研究開発の内容及び成果等
本研究開発では、1 ヶ月間の使用が可能な経皮的心肺補助(PCPS)システム、および恒久的循環補助(DT)が可能な超小型高性能の体内埋込式補助人工心臓(VAD)ポンプについて、従来開発してきた、経皮的心肺補助システム及びセンサレスで恒久的耐久性を有する流体動圧軸受を組合せた動圧軸受軸流ポンプ式VAD について、従来の動物実験により生体適合性確保のために改良してきた設計を最終的な臨床モデルとして確立する。
英文要約Title: In vitro anti-thrombogenic testing of a disposable centrifugal blood pump and durability test of an axial-flow-type ventricular assist pump with hydrodynamic bearing(FY2009-FY2011)FY2010 Annual Report

Regarding the in vitro antithrombogenic testing of a disposable centrifugal blood
pump, in vitro antithrombogenic testing was conducted as the pre-evaluation before
animal experiments for the use of percutaneous cardiopulmonary support (PCPS) or of
extracorporeal membrane oxygenation (ECMO). The test was carried out for two pumps
by using fresh bovine blood with sodium tricitrate as an anticoagulant, during two hours
at 37 degrees with a target ACT of 180-200 s. The concentration of activity of blood
coagulation factors did not remarkably change during both two in vitro antithrombogenic
testing with elapsed time. However, when the test pump was changed in animal
experiment, the concentration of TAT increased whereas D-dimer decreased. These
results are thought to be due to the addition of heparin. The concentration of PF4
increased a little, and did not show a remarkable increase, though PF4 is an index of the
activation of platelets. From these results, it was confirmed that the concentration of
blood coagulation factors are not dominant but ACT is more important for thrombus
formation by in vitro antithrombogenic testing.

Regarding the durability tests for a newly developed axial-flow ventricular assist
device with hydrodynamic bearings, a mock circulatory system under pulsatile flow
condition was improved and has been operated for 9 months as a preliminary test before
the final 2-year durability test. A mock circulation system using a diaphragm pump and
saline with added glycerin as a blood analog fluid was adjusted to achieve a pulsatile
flow rate of 0 to 9 L/min as peak-to-peak values. The layout and sealing of the system
were investigated to achieve long-term reliability of the pulsatile flow. The layout of the
circulatory loop was made more compact to allow more easy arrangement and
observation of multiple circulatory loop. The mock circulation system was fully sealed to
prevent leakage of the working fluid. The durability test of the axial-flow ventricular
assist pump was successfully continued for 268 days using the improved mock
circulatory system. A real-time monitoring system measures the pump flow rate,
pressure head, impeller rotational speed and power consumption. The mock circulatory
system maintains the temperature and density of the working fluid and pulse rate of the
diaphragm pump. Although some minor problems have appeared with respect to the
level of the working fluid in the compliance tank and wear on the crank of the
diaphragm pump, these were corrected by adjusting the level constant and replacing
parts. The test conditions were successfully kept within the allowance levels. However, it
was found that a quite little iron (Fe) ion was extracted into the working fluid.
Regarding the mean flow rate, since there are opinions that 3.4 L/min was too low for the
durability test, suitable experimental conditions were investigated. Based on the tests of
different check valves, it was found that an artificial heart valve was the candidate for
the durability test mock circulation.

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