成果報告書詳細
管理番号20120000000065
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」
公開日2012/12/26
報告書年度2010-2010
委託先名独立行政法人国立循環器病研究センター
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:研究開発の内容及び成果等
本研究では、これまで我々の研究グループが開発・評価を進めてきた動圧軸受方式の超小型軸流型血液ポンプ技術を応用・発展させることにより、 1) 1ケ月間の使用が可能な経皮的心肺補助(percutaneous Cardiopulmonarysupp0此: PCPS)システム、 2)恒久的循環補助(人工心臓による destinationtherapy:
DT)を目的とした超小型高性能の体内埋込式補助人工心臓(ventricularassistdevice:VAD)システム、を開発・製品化することを目的とする。以下に平成21年度に実施した研究内容およびその成果に関して述ベる.
英文要約Development of the Next-Generation Cardiopulmonary Support System
1. Development of Centrifugal Pump System
The centrifugal blood pump head was successfully manufactured by injection molding. The smooth transition between the components was successfully realized through tesing several adhesive methods.
2. Development of the Centrifugal Pump Driver
The prototype of the centrifugal pump driver was designed and manufactured.
3. Electric Safety Assessment and ElectroMagnetic Compatibility Assessment
The centrifugal pump system passed all the tested items except for the probe of the flowmeter. The countermeasures to this problem are considered to be effective.
4. In vitro antithrombogenic testing
In vitro antithrombogenic 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.
5. Blood compatibility tesing of the centrifugal pump
The hemolysis testings were performed in order to assess the mechanical damage of the blood cells through the pump. The pump by injection molding demonstrated a superior performance about mechanical hemolysis at the working point of 5 L/min, 400 mmHg, which was considered to be an typical condition for an ECMO or a PCPS.
6. Biocompatibility testing (chronic animal testing) of the cardiopulmonary support system.
The biocompatibility including antithrombogenicity of the system was investigated through the chronic animal experiment. The PCPS system consisting of the centrifugal pump (injection molding) was installed to an adult goat to perform the veno-arterial bypass. The pump speed was adjusted to have the flow rate of 3.0 L/min. No anticoagulant agents were used throughtout the 30 days of experiment.
7. Biocompatibility testing of the materials of the cardiopulmonary support system.
The manufacturing process was assessed in terms of the biomaterials and the possible chemical changes during the manufacturing processes.
1. Design modification of the implantable ventricular assist system
The design modifications of the axial flow pump toward the final clinical model were carried out.
2. Biocompatibility testings by chronic animal experiments
The chronic animal experiments of the implantable system were performed in the Dept. Artificial Organs, NCVC. Three experiments were carried out, and in two cases the animals survived 90 days and were sacrificed on schedule. In one case, the animal died of massive bleeding that was unrelated to the device.
3. Durability testings
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.
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