Performance Evaluation of MiTiHeart LVAD

MiTiHeart LVAD 性能评估

• 批准号: 6992374
• 负责人: Said Jahanmir
• 金额: $ 92.12万
• 依托单位: MOHAWK INNOVATIVE TECHNOLOGY, INC.
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-07-15 至 2008-08-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6992374
• 关键词: antithrombogenic surface; biomedical device power system; biomedical equipment development; circulatory assist; congestive heart failure; cow; heart prosthesis; heart ventricle; hemolysis; medical implant science; portable biomedical equipment; surface coating; thrombosis

DESCRIPTION (provided by applicant): The overall objective of the proposed Competing Continuation is to develop and incorporate into the MiTiHeart LVAD those elements necessary to meet the requirements for FDA IDE application. In support of this goal and based on initial FDA communications, it has been determined that the addition of a validated electronic controller and power supply system to the MiTiHeart LVAD along with additional in vitro and in vivo testing are needed to support the IDE application. The MiTiHeart LVAD, which has been developed under previous SBIR Grants and company funds, is a small non-thrombogenic rotary pump with magnetic levitation and a redundant hydrodynamic thrust bearing system. The current design specifies that all blood-contacting surfaces be manufactured from TI-6AI-4V alloy and coated with an innovative fully hydrogenated diamond like carbon (DLC) coating. A heparinized organic film overcoat is applied to all rotating DLC coated blood-contacting surfaces. The combination of hydrophobic DLC coating and hydrophilic organic coating provides an innovative means to reduce the shear stresses and minimize platelet activation, thereby reducing the potential for hemolysis and thrombosis. The proposed performance tests include in vitro hemolysis tests, in vivo bovine calf animal testing, and in vitro long-term durability tests. All LVAD components will be inspected following each test for indications of thrombus formation or coating degradation and will be modified if necessary before embarking on the next test. The following Specific Aims are planned for the proposed SBIR Competing Continuation program: (1) Develop the controller and power supply system for the MiTiHeart LVAD, (2) Manufacture blood pumps for performance evaluations, (3) Conduct in vitro hemolysis testing, (4) Conduct in vivo animal testing using a bovine calf model, and (5) Perform in vitro performance and durability testing. As a result of this program a reliable and thoroughly characterized LVAD with percutaneous controller and power supply system will be readied for additional preclinical testing required prior to submission of the IDE application. In the commercialization efforts of Phase II, the technology developed under this study will be transferred to MiTiHeart Corporation, a subsidiary MiTi, established to manufacture and market unique blood pumps for use as destination therapy for adult heart failure patients of small to medium frame that are not being served by present pulsatile devices.

描述（由申请人提供）： 拟议竞争延续的总体目标是开发满足 FDA IDE 应用要求所需的元素并将其纳入 MiTiHeart LVAD 中。为了支持这一目标并根据 FDA 的初步沟通，已确定需要向 MiTiHeart LVAD 添加经过验证的电子控制器和电源系统以及额外的体外和体内测试来支持 IDE 应用。 MiTiHeart LVAD 是在之前的 SBIR 拨款和公司资金下开发的，是一种小型非血栓旋转泵，具有磁悬浮和冗余流体动力推力轴承系统。目前的设计规定，所有血液接触表面均由 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。所有旋转的 DLC 涂层血液接触表面均涂有肝素化有机薄膜外套。疏水性 DLC 涂层和亲水性有机涂层的结合提供了一种创新方法，可减少剪切应力并最大限度地减少血小板活化，从而减少溶血和血栓形成的可能性。拟议的性能测试包括体外溶血测试、体内牛犊动物测试和体外长期耐久性测试。每次测试后都会检查所有 LVAD 组件是否有血栓形成或涂层降解的迹象，并在开始下一次测试之前根据需要进行修改。拟议的 SBIR 竞争延续计划计划实现以下具体目标：(1) 开发 MiTiHeart LVAD 的控制器和电源系统，(2) 制造用于性能评估的血泵，(3) 进行体外溶血测试，(4) ) 使用小牛模型进行体内动物测试，以及 (5) 进行体外性能和耐久性测试。该计划的结果是，带有经皮控制器和电源系统的可靠且全面表征的 LVAD 将准备好进行提交 IDE 申请之前所需的额外临床前测试。在第二阶段的商业化工作中，本研究开发的技术将转让给 MiTi 的子公司 MiTiHeart Corporation，该公司的成立是为了制造和销售独特的血泵，用作中小型成人心力衰竭患者的目标治疗，这些患者目前的脉动装置无法提供服务。