Small Non-Thrombogenic Rotary Mag Lev LVAD

小型非血栓旋转磁升压 LVAD

• 批准号: 6793773
• 负责人: Said Jahanmir
• 金额: $ 9.98万
• 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/6793773
• 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 工作的总体目标是设计、制造和评估小型非血栓旋转 LVAD，采用新型生物相容性和非润湿涂层、MiTi 的混合主动、被动磁悬浮系统和冗余流体动力推力轴承。所有血液接触表面均采用 Ti-6AI-4V 合金制成，并涂有创新的完全氢化类金刚石碳 (DLC) 涂层。一层肝素化有机薄膜将涂覆在旋转的 DLC 涂层钛合金表面上。疏水性 DLC 和亲水性有机涂层的结合提供了一种创新方法来减少轴承表面的剪切应力，从而减少溶血和血栓形成的可能性。第一阶段可行性研究的具体目标是 (1) 在钛合金试片上开发界面膜（TiC 和/或 TiN），以增强 DLC 涂层的附着力，并使用传统压痕测试评估涂层附着力，(2) 确认血液相容性通过评估血小板形态和纤维蛋白形成，对 DLC 涂层钛合金测试试样进行测试，并且 (3) 完成 MiTiHeart LVAD 的初步重新设计，体积减少 40%，并纳入疏水轴承表面的概念，同时维持泵的输出。成功完成第一阶段目标后，第二阶段将制造新的血泵。新泵的性能将使用小牛模型进行体外和体内评估。动物测试将在宾夕法尼亚州立大学赫尔希医学中心进行。所提出的集成混合磁轴承离心血泵设计的关键技术创新比现有的脉动配置在机械上更简单且更小，包括（1）新型疏水性氢化DLC涂层和亲水性肝素化薄膜，（2）永磁径向轴承； (3)用于冲击冲击载荷和紧急备用的流体动力推力轴承系统； (4)单个主动控制磁力推力轴承； (5)径向流出叶轮； 6) 高效无刷直流微电机。 MiTiHeart LVAD 将被设计用作现有脉动装置无法治疗的中小型成年心力衰竭患者的目标治疗。最终的 LVAD 设计信息将授权给 MiTi 的子公司 MiTiHeart Corporation，用于进一步的动物测试并启动 FDA 批准程序。