Development of a Minimally Invasive Partial Circulatory Support Device for Chronic Use

项目摘要 Nautilus泵是一种离心式、完全植入式、紧凑型、持久的部分循环辅助装置 通过微创起搏器囊袋方法植入，以支持晚期心力衰竭的LV功能 干预Nautilus泵将通过连接泵的流入连接到体循环 通过经中隔入路连接至置于锁骨下静脉中并定位在左心房中的插管的端口，以及 流出端口连接到与锁骨下动脉相连的血管移植物。这款革命性的部分支撑泵 正在被设计为消除对侵入性技术的需要，以植入完全支持装置（胸骨切开术或 开胸术）并消除对经皮电缆和/或传动系统的需要。Nautilus泵和系统 将是一种微创、低能耗系统，不会对LV施加过多的后负荷， 从而保持脉动性。此外，它将保留天然心脏心室肌的完整性， 最适合LV修复的环境。另一个要集成到泵中的功能是下一代 经皮能量传输（泰特）系统，不需要外部线圈皮肤直接接触电源 泵。这是一个显着的功能，是不存在于任何其他竞争对手的系统。 利用泵亲和定律，其支配离心泵性能，并且对于修改泵以 新的和不同的要求的职责，以及公司广泛的知识产权组合，鹦鹉螺泵 是基于我们的全支撑辅助泵设计的。它将联合收割机永磁悬浮与 低剪切流体动力轴承，以生产超低功耗泵，同时仍保持其上级 全磁悬浮技术的血液处理特征。这种高效的泵然后与 可植入级电池和一个轻便的外部移动的无线电源，使其成为一个完全植入， 无线供电系统，不需要经皮传动系统、直接皮肤接触或庞大的外部 电池.使用全循环支持泵装置的体内初步研究验证了所有创新的 在这项拨款提案中，例如具有低溶血率的高效率泵。 这SBIR第一阶段提出的赠款目标是在两个具体目标，将执行八个 个月在目标1中，将设计Nautilus泵，并制造原型以适应2 - 3 L/min 在生理压力下流动。在目标2中，将使用再循环血液测试回路进行体外研究 测定红细胞溶血、血小板和白细胞活化、vWF降解和功能， 与我们的全循环支持泵和BPX-80 Bio Pump™相比， （Medtronic - Minneapolis，MN，US）。 拟定目标的结论将证明Nautilus泵的可行性和血液相容性 设计它将为第二阶段SBIR赠款申请奠定基础，其中性能，安全性和适用性 除了房间隔插管的开发外，还将在体内环境中评价器械的性能。

PROJECT SUMMARY The Nautilus pump is a centrifugal, totally implantable, compact, long-lasting partial circulatory assist device implanted via a minimally invasive pacemaker pocket approach to support LV function for late-stage heart failure intervention. The Nautilus pump will be connected to the systemic circulation by attachment of the pump’s inflow port to a cannula placed into the subclavian vein and positioned in the left atrium via a transseptal approach, and the outflow port to a vascular graft anastomosed to the subclavian artery. This revolutionary partial support pump is being designed to eliminate the need for invasive techniques to implant full support devices (sternotomy or thoracotomy) and eliminate the need for percutaneous cables and/or drivelines. The Nautilus pump and system will be a minimally invasive, low energy consumption system that will not impose excessive afterload on the LV, therefore maintaining pulsatility. Furthermore, it will retain native heart ventricular muscle integrity, offering the best environment for LV reconditioning. Another feature to be integrated to the pump is the next-generation transcutaneous energy transfer (TET) system, which does not require direct external coil skin contact to power the pump. This is a remarkable feature that is not present in any other competitors’ systems. Leveraging pump affinity laws, which govern centrifugal pump performance and are useful to modify pumps for new and different required duties, and the Company’s extensive intellectual property portfolio, the Nautilus pump is being designed based on our full support assist pump. It will combine permanent magnetic levitation with a low shear hydrodynamic bearing to produce an ultra-low power consumption pump that still retains the superior blood handling characteristics of full maglev technology. This highly efficient pump is then combined with implantable grade batteries and a light, external mobile wireless power source, making it a totally implanted and wirelessly powered system that does not require a percutaneous driveline, direct skin contact, or bulky external batteries. In-vivo preliminary studies using the full circulatory support pump device validated all the innovative features in this grant proposal, such as a high-efficiency pump with a low hemolysis rate. This SBIR Phase I proposed grant objectives are addressed in two specific aims that will be executed for eight months. In Aim 1, the Nautilus pump will be designed, and a prototype is fabricated to accommodate 2 – 3 L/min flows at physiologic pressures. In Aim 2, in-vitro studies, using a recirculating blood test loop, will be performed to determine red blood cell hemolysis, platelet and leukocyte activation, vWF degradation, and function, as well as overall blood hemostatic potential, compared to our full circulatory support pump and the BPX-80 Bio Pump™ (Medtronic - Minneapolis, MN, US). The conclusion of the proposed aims will demonstrate the feasibility and hemocompatibility of the Nautilus pump design. It will set the stage for a Phase II SBIR grant application where the performance, safety, and suitability of the device will be evaluated in an in-vivo setting, in addition to the development of a transeptal cannula.