Development of the next generation implantable pneumatic ventricular assist device for permanent use.

开发永久使用的下一代植入式气动心室辅助装置。

• 批准号: 17390356
• 负责人: HOMMA Akihiko
• 金额: $ 10.72万
• 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 Scientific Research (B)
• 财政年份: 2005
• 资助国家: 日本
• 起止时间: 2005 至 2007
• 项目状态: 已结题
• 来源: https://kaken.nii.ac.jp/grant/KAKENHI-PROJECT-17390356/
• 关键词: ventricular assist device; blood pump; drive unit; antithrombogenic surface treatment; percutaneous system

The purpose of this work is to develop a next generation implantable pneumatic ventricular asist device(P-VAD) for permanent use. A diaphragm type blood pump for the implantable P-VAD has been developed. The mount angle of the inlet and outlet value affects the flow bahavior the blood pump and thrombus formation. The effect of the orifice direction of the inlet and outlet valve(ODIV, ODOV ; where direction toward the diaphragm-housing junction(DHJ) was defined as 0 degrees) was investigated by means of particle image velocimetry(PIV) visualization method. Monoleaflet mechanical valves(Medtronic-Hall Valve, (ρ23mm) was used. The observed flow velocity distribution was relatively low in the area between the inlet and outlet port roots, it was lowest(0.05m/s) at the 90 degrees ODIV. On the other hand, the flow velocity distribution in this area was highest(1.9m/s) at 135 degrees ODIV. Furthermore, the flow velocity of marginal area near the DHJ was relatively high at 135 degrees ODOV, and … More relatively low at 45 degree ODOV. The flow velocity in the proximal to the inlet port at 135 degrees ODOV(0.05m/s-0.65m/s) was always higher then that at 45 degrees ODOV(0.05m/s-0.22m/s) at any time of the beat cycle.The flow behavior inside the blood pump is significantly affected by the ODIV and ODOV, in terms of flow stagnation and thrombus formation.The cavitation which was generated with opening and closing of a valve causes erosion of the valve surface and hemolyzed blood. The effect of the valve orientation angle on a bileaflet mechanical heart valve(MHV) cavitations was investigated. A23mm Edwards MIRA bileaflet valve was used and the valve was rotated from o to 90 degrees on an inclined horizontal plane. The valve-closing motion was measured by means of a CCD laser displacement sensor. Images of MHV cavitation bubbles were recorded using a high-speed video camera. The contact delay time ranged from 0.88+/-0.41 to 0.50+/-0.27ms, and the time for the valve orientation angles of 0 and 30 degrees was longer than of the angle of 45, 60 and 90 degrees. The cavitation bubbles were caused by the first valve closure, valve rebound and the second valve closure, and were concentrated along the tip of the leaflet. The cavitation bubbles of the left side leaflet were caused by the first valve closure only at orientation angles of 45, 60, 90 degrees. The observation time of the cavitation bubbles caused by the first valve closure at 45, 60 and 90 degrees was longer that that of the bubbles caused by the valve rebound. The mechanism for the occurrence of MHV xcavitation differs from the valve closure motion. Valve orientation was found to affect the asynchronous closure motion of the two leaflet and the cavitation mechanism.Driveline infection is a serious major problem for the patients with an implantable VAD system. The novel percutaneous system to connect between an outer surface of percutaneous driveline and subcutaneous tissue was developed. This system mainly consists of porous segmented polyurethane with the three-dimensional reticulated structure which has tissue-like flexibility and sufficient mechanical strength. The test materials which inserted into the silicone tube implanted into subcutaneous tissue of an adult goat and tissue-compatibility of this material was investigated. The granulated tissue infiltrated into the test tube after 30 days implantation. Infiltrated tissue included the mature connective tissue, and did not include inflammatory or necrotic foci in the test tubes. The newly developed material has a sufficient ability to connect the percutanelus driveline and subcutaneous tissue in destination therapy with implantable VAD.A compact wearable pneumatic drive unit for ventricular assist device was developed. The drive unit consists of a brushless DC motor, a crankshaft, a cylinder piston, noncircular gears and air pressure regulation valves. Driving air pressure is generated by the cylinder piston. The noncircular gears generate the systolic ratio and the air pressure regulation valves limit the maximum and minimum pressure. The weight of the drive unit is approximately 1.8kg. The drive unit of 44% systolic ratio using a blood pump of 70mL stroke volume achieved more than 7L/min of pump output at 100bpm against after-load of 120mmHg in an overflow type mock circulation. The average electric power consumption varied from 8.6 to 17.7W with the beating rate and the after-load. The chronic animal tests using 2 Holstein calves weighing 62kg and 74kg with the drive units of 45 and 53% systolic ratio terminated on 30 and 39days without any malfunction. In the first animal test, the mean aortic pressures, bypass flows and electric power consumptions were maintained at 90+/-13mm Hg, 3.9+/-0.9L/min and 12+/-1W, respectively. In the second animal test, those values were maintained at 88+/-13mmHg, 5.0+/-0.5L/min and 16+/-2W. These results indicate that the newly developed drive unit has a potential to become a wearable drive unit. Less

本工作的目的是开发下一代永久性植入式气动心室辅助装置（P-VAD）。研制了一种用于植入式P-VAD的隔膜式血泵。进出口阀的安装角度影响流量平衡或血泵和血栓的形成。采用粒子图像测速（PIV）可视化方法研究了进、出口阀的节流孔方向（ODIV，ODOV ;其中，朝向阀壳连接处（DHJ）的方向定义为0 °）的影响。使用单瓣机械瓣膜（Medtronic-Hall瓣膜，（ρ 23 mm））。观察到的流速分布在入口和出口端口根部之间的区域相对较低，在90 ° ODIV处最低（0.05m/s）。另一方面，该区域的流速分布在135度ODIV时最高（1.9m/s）。此外，在135 ° ODOV时，DHJ附近边缘区域的流速相对较高， ...更多信息 在45度ODOV时相对较低。在135度ODOV时，入口近端的流速（0.05m/s-0.65m/s）始终高于45 ° ODOV时的（0.05m/s-0.22m/s）。ODIV和ODOV显著影响血泵内的流动行为，在流动停滞和血栓形成方面。随着瓣膜的打开和关闭而产生的空化导致瓣膜表面的侵蚀和溶血的血液。本文研究了双叶机械心脏瓣膜（MHV）的瓣膜方位角对瓣膜空化的影响。使用23 mm Edwards MIRA双叶瓣膜，在倾斜水平面上将瓣膜从0度旋转至90度。通过CCD激光位移传感器测量阀门关闭运动。使用高速摄像机记录MHV空化气泡的图像。接触延迟时间范围为0.88+/-0.41到0.50+/-0.27ms，0 °和30 °的阀取向角的时间长于45 °、60 °和90 °的阀取向角的时间。空化气泡由第一次瓣膜关闭、瓣膜回弹和第二次瓣膜关闭引起，并沿瓣叶尖端沿着。左侧瓣叶的空化气泡仅在45、60、90度定向角时由第一次瓣膜关闭引起。在45 °、60 °和90 °时，首次关阀引起的空泡的观察时间比阀门回弹引起的空泡的观察时间长。MHV空化的发生机制与阀门关闭运动不同。瓣膜方向影响两个瓣叶的异步关闭运动和空化机制。传动系统感染是植入VAD系统患者的严重问题。开发了用于连接经皮传动系统的外表面和皮下组织之间的新型经皮系统。该系统主要由多孔嵌段聚氨酯组成，具有三维网状结构，具有组织般的柔韧性和足够的机械强度。将试验材料插入植入成年山羊皮下组织的硅胶管中，研究该材料的组织相容性。植入30天后，颗粒组织浸润到试管中。浸润组织包括成熟结缔组织，不包括试管中的炎性或坏死灶。新开发的材料具有足够的能力连接经皮驱动线和皮下组织的目标治疗与植入式VAD。驱动装置由无刷直流电机、曲轴、气缸活塞、非圆齿轮和气压调节阀组成。驱动空气压力由气缸活塞产生。非圆齿轮产生收缩比，气压调节阀限制最大和最小压力。驱动装置的重量约为1.8kg。收缩比为44%的驱动装置使用70 mL心搏量的血泵在溢流型模拟循环中在120 mmHg的后负荷下以100 bpm获得大于7 L/min的泵输出。平均耗电量随打浆率和后负荷的变化而变化，在8.6 ~ 17.7W之间。用2头体重分别为62 kg和74 kg的荷斯坦犊牛进行慢性动物试验，分别在收缩比为45%和53%的驱动装置下，于30天和39天结束，无任何故障。在第一次动物试验中，平均主动脉压、旁路流量和耗电量分别维持在90+/-13 mm Hg、3.9+/-0.9 L/min和12+/-1 W。在第二次动物试验中，这些值保持在88+/-13mmHg，5.0 +/-0.5L/min和16+/-2W。这些结果表明，新开发的驱动单元具有成为可穿戴驱动单元的潜力。少

项目成果

CAPD施行時における出口部感染防止に有用な皮膚貫通デバイスの開発

开发可用于预防 CAPD 期间出口部位感染的皮肤穿透装置

• 发表时间: 2006
• 期刊: 人工臓器 Vol.35, No.2
• 作者: 青山真人;水野敏秀;根本泰;岡本吉弘;田中秀幸;築谷朋典;本間章彦;西中知博;巽英介;武本佳昭;仲谷達也;妙中義之
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• 发表时间: 2005
• 期刊: 人工臓器 Vol.34,No.2
• 作者: 李桓成;巽英介;築谷朋典;本間章彦;上村匡敬;赤川英毅;妙中義之
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一种新型经皮系统的新颖开发，用于目标治疗中的植入式 VAD 系统

• 发表时间: 2005
• 作者: T. Mizuno;E. Tatsumi;Y. Nemoto;Y. Nakayama;S. Saito;Y. Okamoto;T. Tsukaya;Y. Takewa;A. Homma;S. Kitamura;Y. Taenaka
• 通讯作者: Y. Taenaka

小型装着式を目指した空気圧駆動式補助人工心臓用駆動装置の開発

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• 发表时间: 2007
• 期刊: ライフサポート学会 Vol.19,No.3
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空気駆動による可搬型補助人工心臓駆動装置

气动便携式辅助人工心脏驱动装置

• 发表时间: 2007
• 期刊: フルードパワーシステム Vol.38, No.4
• 作者: Mizuno M;Kamiya A;Kawada T;Miyamoto T;Shimizu S;Sugimachi M.;本間章彦,巽英介
• 通讯作者: 本間章彦,巽英介