PREFABRICATION DESIGN CONSIDERATIONS FOR A LONG-TERM ELECTRICALLY-ACTUATED ABDOMINAL LEFT VENTRICULAR ASSIST DEVICE (E-TYPE ALVAD)

摘要

The conceptual design and development of a long-term, low-profile intracorporeal left ventricular assist device is a multifaceted project involving a series of technical, anatomic and physiologic considerations. Patients with severe left ventricular failure refractory to all other forms of therapy could benefit from such a device. Prior to fabrication of such a blood pump, consideration must be given to physiologic parameters of the projected patient population. The pump must be designed to meet physiologic demands and yet conform to the anatomic constraints posed by the patient population. We measured the body surface area (BSA) of a group of patients (n=50) and found the mean BSA for this group to be 1.804 ± 0.161 m². Using 25 ml/m² as a stroke volume index indicative of left ventricular failure and a stroke volume index of 45 ml/m² as normal, distributions of stroke volumes (normal and in left ventricular failure) were plotted for a potential population and demonstrated that 63% of the projected population can be returned to normal by a pump with a stroke volume ≥ 83 ml. Cadaver fitting studies established that 73% of the potential population can accommodate an ALVAD 10.8 cm in diameter. In-vitro tests demonstrated that a pump stroke volume ≥ 83 ml could be achieved by the proposed pump with a 15 mmHg filling pressure at rates up to 125 B/min. A pusher-plate stroke of 0.56 inches would be necessary to provide a stroke volume ≥ 83 ml. The percent of the patient population that could be served was determined by excluding those in whom the pump would not fit or in whom it would provide less than a normal resting stroke volume. Approximately 73% of the projected patient population would accommodate this pump and be returned to normal circulatory dynamics.