Development of a Miniature Hydrodynamically Suspended Intrathoracic Tesla Pump

描述（由申请人提供）：本研究的长期目标是将完全植入式LVAD系统商业化，该系统比现有经皮LVAD系统更便宜、更可靠、生物相容性更好。左心室辅助装置（LVAD）显著改善了过渡到移植和终末期心力衰竭目的地治疗的患者的生存率。然而，为了使LVAD对慢性心力衰竭具有显著的流行病学影响，需要改进设备以减少感染，预防非手术胃肠道出血，提供自动速度控制并降低成本。我们建议继续开发独特的特斯拉旋转泵，并使用无线能量传输集成自动速度控制和完整的可植入性。具体目标是：1.改进第一阶段设计，以实现可植入性、压力传感器集成和进一步缩小尺寸。将使用更薄的部分和焊接结构重新设计泵，在入口套管主体中安装压力传感器。这两种改进都将减小泵的尺寸。2.通过体外性能测试和体内研究，测试具有集成压力控制的最终泵设计。重新设计的泵将首先使用外部控制器和硬线来确认和验证系统软件和血泵性能。在获得令人满意的体外性能和动态响应后，将硬连线泵植入小牛体内进行急性研究。3.开发植入式电子产品、植入式电池组、TETS和外部组件。我们将重新设计和改进现有的选定组件，如TETS初级和次级线圈、患者外部电子设备、密封连接器、电池组和外壳。将应用与之前植入系统相同的设计知识。4.在体外和体内测试完全集成的无线系统。将对集成系统进行体外试验和有限的IDE前试验。将在牛模型中通过急性和慢性研究评价完整系统。将进行急性研究，以评估系统对不同生理条件的反应。将进行长期30天体内研究，通过仔细检查植入组件以及尸检和组织学结果来评估系统的生物相容性。5.为预IDE提交制定设计、制造和测试文档。在整个项目设计文档和设计控制过程中，将使用FDA质量体系法规（QSR）中所述的内容向FDA提供全面的设计文档文件。这些技术是确保成功设计的非常有效的工具，也是FDA的要求。 公共卫生相关性：Tesla泵左心室辅助系统是一种完全植入式无线系统，旨在成为当前LVAD技术的更可靠、更便宜的替代品。这种装置具有极大地扩展LVAD治疗在需要长期机械循环支持的患者中的使用的潜力。

DESCRIPTION (provided by applicant): The long term objective of this research is to commercialize a completely implantable LVAD system that is less expensive, more reliable and more biocompatible than existing percutaneous LVAD systems. Left ventricular assist devices (LVADs) have significantly improved survival in patients bridged to transplant and in destination therapy for end stage heart failure. However, for LVADs to have a significant epidemiological impact on chronic heart failure, device improvements are needed to reduce infection, prevent non-surgical gastrointestinal bleeding, provide automatic speed control, and reduce cost. We propose to continue development of a unique Tesla rotary pump, and to integrate automatic speed control and complete implantability using wireless energy transmission. The specific aims are: 1. Refine the Phase I design for implantability, integration of pressure sensor, and further size reduction. The pump will be redesigned using thinner sections and a welded construction, with a pressure sensor in the inlet cannula body. Both of these modifications will reduce the pump size. 2. Test the final pump design with integrated pressure-based control through in vitro performance testing and in vivo studies. The redesigned pump will first use an external controller and hardwire for validation and verification of the system software and blood pump performance. After achieving satisfactory in vitro performance and dynamic response, the hardwired pump will be implanted in calves for acute studies. 3. Develop implantable electronics, implantable battery pack, TETS and external components. We will redesign and improve existing selected components such as the TETS primary and secondary coils, the patient external electronics, hermetic connectors, battery packs and enclosures. The same design knowledge applied to previous implanted systems will be applied. 4. Test the fully integrated, wireless system in vitro and in vivo. In vitro testing and limited pre-IDE testing willbe carried out on the integrated system. Complete systems will be evaluated in the bovine model with both acute and chronic studies. Acute studies will be performed to assess the system response to varying physiologic conditions. Chronic 30 day in vivo studies will be conducted to assess the biocompatibility of the system using careful examination of explanted components as well as necropsy and histology findings. 5. Develop design, manufacturing, and test documentation for pre-IDE submission. Throughout the project design documentation and design controls, as described in the FDA Quality System Regulation (QSR) will be utilized to provide a comprehensive design documentation file to the FDA. These techniques are a very effective tool in assuring a successful design and are a requirement of the FDA. PUBLIC HEALTH RELEVANCE: The Tesla pump Left Ventricular Assist System is a completely implantable wireless system intended to be a more reliable, less expensive alternative to current LVAD technologies. Such a device has the potential to greatly expand the use of LVAD therapy in patients requiring long term mechanical circulatory support.