World-first implantable aortic valvo-pump (IAVP) with sufficient haemodynamic capacity

Abstract

For better anatomic and physiologic fitting, a novel implantable aortic valvo-pump (IAVP) has been developed. A valvo-pump is a micro axial flow impeller pump, which has the same dimensions and function, as well as the same location, of a valve. Therefore, IAVP needs no inlet and outlet tubes, no additional anatomic occupation, and has less physiologic disturbance to natural circulation compared with the traditional bypass left ventricular assist device (LVAD). The device has a stator and a rotor. The stator consists of a motor coil with an iron core and an outflow guide vane; the rotor includes driven magnets and impeller. There is neither bearing nor strut in both the pump and the motor. In order to reduce the attractive force between the rotor and the stator, so as to enhance the durability of the performance, the rotor magnets were minimized without reducing the driving torque and efficiency of the motor. The impeller vane was designed according to a three-dimensional and analytical method, for preventing stasis and turbulence. The largest outer diameter is 24.7 mm and the length at this point is 12.4 mm. The total weight is 40 g (including the rotor of 11 g). The consumed power is 7 W (14 V × 0.5 A) at 15 000 rpm. This rotating speed stays unchanged during haemodynamic testing together with a pulsatile centrifugal pump, which imitates a failing ventricle. The maximal flow cross IAVP reaches over 10 l min⁻¹ and the pressure head at 0 l min⁻¹ can be as large as 80 mmHg. At flow rate of 4 – 8 l min⁻¹, IAVP enlarges the flow c. 1 l min⁻¹ and meanwhile increases the pressure about 10 mmHg. The pressure pulsatility generated by the pulsatile centrifugal pump remains 40 mmHg after passing IAVP. By first animal experimental trial the device was sewed in aortic position of an 80 kg pig without harm to adjacent tissue and organs. IAVP promises to be a viable alternative to natural donor heart for heart transplantation in the future.