Developement of pediatric size ventricular assist device for therapeutic use in profound heart failure after open heart surgery.

开发儿童尺寸的心室辅助装置，用于心脏直视手术后严重心力衰竭的治疗。

• 批准号: 59870047
• 负责人: NAKATANI Takeshi
• 金额: $ 2.37万
• 依托单位: National Cardiovascular Center Research Institute
• 依托单位国家: 日本
• 项目类别: Grant-in-Aid for Developmental Scientific Research
• 财政年份: 1984
• 资助国家: 日本
• 起止时间: 1984 至 1985
• 项目状态: 已结题
• 来源: https://kaken.nii.ac.jp/en/grant/KAKENHI-PROJECT-59870047/
• 关键词: Ventricular Assist Device; Profound Heart Failure; Congenital Heart Disease; 小児用補助心臓

In children as in adults, there are many patients who develop profound heart failure after open heart surgery. Since IABP and veno-arterial bypass are not effective and complicated, more effective and safer cardiac assistance is needed. So we have developed pediatric size air-driven and diaphragm type ventricular assist device(VAD) for children. Its stroke volume is 20 ml and it is made of segmented polyether polyurethane(TOYOBO TM-series) and contains two #21 Bjork-Shiley valves. The conduits are made of polyvinylchloride and their inner surface is coated with TM-3. The IDs of inlet and outlet conduet are 6 and 8 mm. The control drive unit is the same as that developed for adult use in our center.In vitro performance demonstrated that the pump could yield sufficient flow and had a good ability to follow tachycardia.The results of the chronic animal experiments using young goats(body weight: 9-17 kg) indicated that VAD for children had excellent in vivo performance in several aspects. These included ease of implantation, sufficient capability for circulrtory support, good antithrombogenicity, high durability and no harm on the blood chemistry of young and immature animals.And we had one clinical case. He was 3 year-old boy and operation was done for ventricular septal defect. After that he could not be weaned from extracorporeal circulation, so this VAD was applied.The entire circulation was well maintained and he was weaned from VAD after 3 days pumping because of his heart recovery.So we believe this VAD can be an effective and safe approach for treating the child with postoperative profound heart failure.

在儿童和成人中，有许多患者在心脏直视手术后发生严重心力衰竭。IABP和静脉-动脉旁路移植术效果不佳且复杂，因此需要更有效、更安全的心脏辅助。为此，我们研制了小儿尺寸的气动隔膜式心室辅助装置。其冲程容积为20 ml，由多段聚醚聚氨酯（TOYOBO TM系列）制成，并包含两个#21 Bjork-Shiley阀。导管由聚氯乙烯制成，其内表面涂有TM-3。该泵的入口内径为6 mm，出口内径为8 mm，控制驱动装置与我中心研制的成人用泵相同，体外性能表明，该泵能产生足够的流量，并具有良好的跟随心动过速的能力。（体重：9-17 kg）表明，儿童VAD在几个方面具有优异的体内性能。这些优点包括易于植入、足够的循环支持能力、良好的抗血栓性、高耐久性和对年幼和未成熟动物的血液化学无损害。他是一名3岁男孩，因室间隔缺损接受了手术。由于患儿无法脱离体外循环，因此应用了VAD，整个循环维持良好，3天后因心脏恢复而脱离VAD，因此我们认为该VAD是治疗术后重度心力衰竭患儿的一种有效和安全的方法。

项目成果

人工臓器. 16. (1986)

人造器官。16。（1986）

Jpn J Med Instrumentation. 54(Suppl):40. (1984)

日本医学仪器杂志。

Trans Am Soc Artif Intern Organs. 30 : 155. (1984)

Trans Am Soc Artif 实习生器官。

Jpn J Artif Organs. 15. (1986)

Jpn J Artif 器官。