Performance Evaluation of MiTiHeart LVAD

MiTiHeart LVAD 性能评估

• 批准号: 7110934
• 负责人: Said Jahanmir
• 金额: $ 98.03万
• 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 2008-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7110934
• 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)： 拟议的竞争性延续的总体目标是开发符合FDA IDE应用要求的必要元素，并将其纳入MiTiHeart LVAD。为了支持这一目标，并根据FDA的初步沟通，已经确定需要在MiTiHeart LVAD上增加一个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，以支持IDE应用。米蒂哈特LVAD是在之前的SBIR赠款和公司资金的支持下开发的，是一种带有磁悬浮和冗余流体动力推力轴承系统的小型无血栓旋转泵。目前的设计规定，所有与血液接触的表面都由TI-6AI-4V合金制造，并涂上创新的完全氢化类金刚石(DLC)涂层。所有旋转的DLC涂层血液接触表面都涂有肝素化的有机薄膜涂层。疏水性DLC涂层和亲水性有机涂层的结合提供了一种创新的方法来降低切应力和最大限度地减少血小板激活，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。所有LVAD组件将在每次测试后检查血栓形成或涂层降解的迹象，并将在进行下一次测试之前进行必要的修改。为拟议的SBIR竞争延续计划计划了以下具体目标：(1)开发MiTiHeart LVAD的控制器和供电系统，(2)制造用于性能评估的血泵，(3)进行体外溶血测试，(4)使用牛犊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。作为这一计划的结果，具有经皮控制器和电源系统的可靠和完全特性化的LVAD将为提交IDE申请之前所需的额外临床前测试做好准备。在第二阶段的商业化工作中，根据这项研究开发的技术将转移给MITI的子公司MiTiHeart公司，该公司成立的目的是制造和销售独特的血泵，作为目前脉动设备没有提供服务的中小框架成年心力衰竭患者的目的地疗法。