Small Non-Thrombogenic Rotary Mag Lev LVAD

小型非血栓旋转磁升压 LVAD

• 批准号: 6889588
• 负责人: Said Jahanmir
• 金额: $ 37.59万
• 依托单位: MOHAWK INNOVATIVE TECHNOLOGY, INC.
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-05-01 至 2007-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6889588
• 关键词: antithrombogenic surface; auxiliary heart prosthesis; bioengineering /biomedical engineering; biomaterial compatibility; biomaterial development /preparation; biomedical equipment development; blood volume; chemical property; circulatory assist; fibrin; intracardiac volume; medical implant science; platelet activation; shear stress; surface coating; technology /technique development

DESCRIPTION (provided by applicant): The overall objective of the proposed SBIR effort is to design, manufacture, and evaluate a small non-thrombogenic rotary LVAD employing a novel biocompatible and non-wetting coating, MiTi's hybrid active.passive magnetic levitation system and a redundant hydrodynamic thrust bearing. All blood-contacting surfaces will be manufactured from Ti-6AI-4V alloy coated with an innovative fully hydrogenated diamond like carbon (DLC) coating. A top layer of heparinized organic film will be applied to the rotating DLC coated titanium alloy surfaces. The combination of hydrophobic DLC and hydrophilic organic coating provides an innovative means to reduce the shear stresses on bearing surfaces, thus reducing the potential for hemolysis and thrombosis. The Specific Aims of the Phase I feasibility study are to (1) develop an interfacial film (TiC and/or TiN) on titanium alloy test coupons to enhance adhesion of DLC coating and evaluate coating adhesion using conventional indentation testing, (2) confirm hemocompatibility of DLC coated titanium alloy test coupons through assessment of platelet morphology and fibrin formation, and (3) complete the preliminary redesign the MiTiHeart LVAD for 40% volume reduction and incorporate the concept of hydrophobic bearing surfaces while maintaining the pump output. Upon successful completion of Phase I objectives, a new blood pump will be manufactured in phase II. The performance of the new pump will be evaluated in vitro and in vivo using a bovine calf model. The animal testing will be conducted at the Pennsylvania State University, Hershey Medical Center. Key technical innovations of the proposed integrated hybrid magnetic bearing centrifugal blood pump design that is mechanically simpler and smaller than existing pulsatile configurations include (1) a novel hydrophobic, hydrogenated DLC coating and a hydrophillic heparinized film, (2) permanent magnet radial bearings; (3) a hydrodynamic thrust bearing system for impact shock loads and emergency backup; (4) a single actively controlled magnetic thrust bearing; (5) a radial out-flow impeller; and 6) an efficient bushless dc micro-motor. The MiTiHeart LVAD will be designed for use as destination therapy for adult heart failure patients of small to medium frame that are not being served by present pulsatile devices. The final LVAD design information will be licensed to MiTiHeart Corporation, a subsidiary of MiTi, for further animal testing and initiation of the FDA approval process.

描述（由申请人提供）： 拟议的SBIR工作的总体目的是使用新型的生物相容性和非润湿涂层设计，制造和评估一个小的非紧密旋转LVAD，MITI的混合磁性磁极磁性系统和冗余的水动力推力轴承。所有接触表面的表面将由TI-6AI-4V合金制成，这些合金涂有创新的完全氢化钻石（如碳（DLC）涂层）。肝素化有机膜的顶层将应用于旋转的DLC涂层钛合金表面。疏水性DLC和亲水有机涂层的组合提供了一种创新的手段来减少轴承表面上的剪切应力，从而降低了溶血和血栓形成的潜力。第一阶段可行性研究的具体目的是（1）在钛合金合金测试优惠券上开发界面膜（TIC和/或锡），以增强DLC涂层的粘附，并使用常规压痕测试来评估涂层的粘附，（2）通过DLC涂层型钛合金测试量和3）通过DLC涂层质量兼容效率组成的钛合金培训和金属材料来确认，并且初步重新设计了Mitiheart LVAD，以减少40％的体积，并结合疏水轴承表面的概念，同时保持泵输出。成功完成I期目标后，将在第二阶段制造新的血泵。新泵的性能将在体外和体内使用牛牛犊模型进行评估。该动物测试将在宾夕法尼亚州立大学好时医学中心进行。与现有的脉动构型相比，机械上更简单和小的集成杂交磁轴承的关键技术创新包括（1）一种新型的疏水，氢化的DLC涂层和水生电脱镀膜膜，（2）永久磁径径轴承； （3）用于冲击冲击负荷和紧急备份的流体动力推力轴承系统； （4）单个主动控制的磁推力轴承； （5）径向流出的叶轮； 6）有效的无灌木DC微型运动。 Mitiheart LVAD将被设计为作为目的地中等框架的成人心力衰竭患者的目的地治疗，这些患者未由当前的脉动设备提供。最终的LVAD设计信息将获得MITI子公司Mitiheart Corporation的许可，以进一步对FDA批准过程进行进一步的动物测试和启动。