Low-Cost Rotary Blood Pump with ICB Magnetic Support

描述(由申请人提供)： 一种用于永久植入的心脏辅助装置(VAD)的磁悬浮旋转式血泵已经证明了“固有控制轴承”(ICB)的概念。ICB不仅取消了位置传感器，而且还取消了对轴承线圈电流的主动反馈电子控制，并证明了原型ICB的良好效率和高刚度。这项快速通道提案的具体目的是证明，这项创新技术可以推广到生产一种成本非常低、但非常耐用的中期使用的泵，如体外肺支持(ECLS)，或桥接移植/恢复使用。为了实现这一点，泵的设计中将加入几项额外的创新。转子和定子外壳之间的墙将被引入，以将血液通道与现在可分离和可重复使用的定子隔离。马达将重新设计，以提供更大范围的液压输出所需的速度和功率，并减小转子直径，减少粘性阻力损失，比由此导致的速度增加更多，并减少特定液压输出所需的马达扭矩输出。低成本的材料和制造方法将被用来制造这种非永久性、非植入式的泵。第一阶段的成功将是一个原型，在所有运行条件下，轴承具有足够的刚度来抵抗所有施加的冲击和振动负载，并且轴承功率消耗低于2.5W。样机还将展示在电机输入功率低于8W的情况下，在100 mm-Hg压力升高时泵送5升/分钟的能力，在电机功率低于25 W的情况下，在350 mm-Hg压力升高的情况下泵送4升/分钟的能力，以及在最大功率为40 W的情况下，在120 mm-Hg压力升高的情况下泵送9升/分钟的能力。在这里取得成功的好处是，一种通用的核心技术将可用于血泵应用。这种共性将带来成本效益，每年1000或更多的数量，这种简单的一次性元件可以以与现有产品具有竞争力的价格出售。血栓形成率和轴承耐久性也将得到改善，相对较小的尺寸将允许用作可穿戴的桥接移植/恢复装置，它还将为小型患者、LVAD植入后的短暂右室支持或负担不起植入泵成本的市场提供替代方案。

DESCRIPTION (provided by applicant): An "Inherently Controlled Bearing" (ICB) concept has been demonstrated in a magnetically suspended rotary blood pump intended for use as a permanently implanted ventricular assist device (VAD). The ICB eliminates not only position sensors but also active feedback electronic control of the bearing coil currents, and good efficiency and high stiffness of a prototype ICB has been documented. The specific aim of this Fast-Track proposal is to demonstrate that this innovative technology can be extended to produce a very low cost, yet highly durable, pump for medium-term uses, such as extracorporeal lung support (ECLS), or bridge-to-transplant/recovery use. To accomplish this, several additional innovations will be incorporated in the pump design. Walls between the rotor and stator housings will be introduced to isolate the blood path from the now separable and reusable stators. The motor will be redesigned to provide the speed and power required for the wider range of hydraulic output, and the rotor diameter decreased, reducing viscous drag losses by more than the resulting speed increase and reducing the motor torque output required for a particular hydraulic output. Lower cost materials and manufacturing methods will be incorporated to fabricate this nonpermanent, nonimplanted pump. Success in Phase I will be a prototype with sufficient stiffness in the bearing to resist all imposed shock and vibration loads and a bearing power consumption below 2.5 W, at all operating conditions. The prototype will also demonstrate an ability to pump 5 liter/min at 100 mm-Hg pressure rise with motor power input below 8 W, an ability to pump 4 liter/min at 350 mm-Hg pressure rise with motor power below 25 W, and an ability to pump 9 liter/min at 120 mm-Hg pressure rise, with 40 W maximum power. The advantage of success here is that a common, core technology will become available for blood pump applications. Cost benefits will accrue from this commonality, and in quantities of 1000 or more per year, the simple disposable element can be sold at a price competitive with existing products. Improvements on rates of thrombus formation and bearing durability will also be realized, and the relatively small size would allow use as a wearable bridge-to-transplant/recovery device, it would also offer an alternative for small patients, for transient right ventricle support after LVAD implant, or for marketplaces that cannot afford implantable pump costs.