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）： SBIR工作的总体目标是设计、制造和评价一种小型非血栓形成旋转LVAD，该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。所有血液接触表面将由Ti-6Al-4V合金制成，并涂有创新的全氢化类金刚石碳（DLC）涂层。将肝素化有机膜顶层应用于旋转DLC涂层钛合金表面。疏水性DLC和亲水性有机涂层的组合提供了一种降低关节面剪切应力的创新方法，从而降低了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）开发界面膜（2）通过评估血小板形态和纤维蛋白形成，确认DLC涂层钛合金试样的血液相容性，和（3）完成MiTiHeart LVAD的初步重新设计，以减少40%的体积，并在保持泵输出的同时纳入疏水轴承表面的概念。成功完成第一阶段目标后，将在第二阶段生产新的血泵。将使用小牛模型在体外和体内评价新泵的性能。动物试验将在宾夕法尼亚州立大学好时医学中心进行。所提出的集成混合磁轴承离心血泵设计的关键技术创新包括：（1）新型疏水氢化DLC涂层和疏水肝素化膜;（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）单个主动控制的磁性推力轴承;（5）径向流出叶轮;以及6）高效无刷直流微型电机。MiTiHeart LVAD将被设计用作目前脉动式器械无法提供服务的中小型成人心力衰竭患者的目标治疗。最终的LVAD设计信息将被授权给MiTi的子公司MiTiHeart Corporation，用于进一步的动物试验和启动FDA批准程序。