Small Non-Thrombogenic Rotary Mag Lev LVAD

描述(由申请人提供)： 拟议中的SBIR工作的总体目标是设计、制造和评估一种小型、非血栓形成的旋转式LVAD，它采用了一种新型的生物兼容和非润湿涂层、MITI的混合主动、被动磁悬浮系统和冗余的流体动力推力轴承。所有与血液接触的表面都将由钛-6AI-4V合金制造，表面涂覆创新的全氢类金刚石(DLC)涂层。在旋转类金刚石涂层钛合金表面涂覆一层肝素化的有机薄膜。疏水性DLC和亲水性有机涂层的结合提供了一种创新的方法来降低轴承表面的剪应力，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)在钛合金测试试片上开发一种界面膜(TiC和/或TiN)，以增强DLC涂层的附着力，并使用常规压痕测试来评估涂层附着力；(2)通过评估血小板形态和纤维蛋白形成来确认DLC涂层测试试片的血液相容性；(3)完成对MiTiHeart LVAD的初步重新设计，以减少40%的体积，在保持泵输出的同时采用疏水轴承表面的概念。在成功完成第一阶段目标后，将在第二阶段制造一种新的血泵。新血泵的性能将使用牛犊模型在体外和体内进行评估。动物实验将在宾夕法尼亚州立大学好时医学中心进行。与现有的脉动配置相比，建议的一体化混合磁力轴承离心式血泵设计的关键技术创新包括：(1)新型疏水、氢化类金刚石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)单主动控制磁力推力轴承，(5)径向流出叶轮，以及6)高效无刷直流微电机。MiTiHeart LVAD将被设计为用于目前脉搏设备没有提供服务的中小型成年心力衰竭患者的目的地治疗。最终的LVAD设计信息将被许可给MITI的子公司MiTiHeart公司，用于进一步的动物试验和启动FDA的批准程序。

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.