Development of a completely implantable total artificial heart.

In conjunction with engineering and physiologic requirements, anatomic fit is a fundamental problem that must be carefully addressed in the design of a truly feasible implantable total circulatory support system. To facilitate the conceptualization, a three-dimensional anatomic model of an average adult thorax was developed from a data bank of 14 human cadavers, 100 radiographs, 18 computerized tomographs, 4 nuclear magnetic resonance (NMR) studies, and 31 cineangiograms. The location and orientation of the valves, the atrial chambers, venae cavae, and pulmonary hili were found to be the most critical information. As a result, configuration of a one piece, completely implantable total artificial heart (E4T system) with the hydraulic actuator placed between the two ventricles was defined and sized to provide an output of 8 L/min at 120 beats/min. The device was designed to be positioned through a midsternotomy similar to the natural ventricles (in the pericardial sac toward the left chest cavity), and the ports were carefully designed to eliminate the risk of compression of critical cardiovascular structures. Validation of the design was conducted with an E4T model implanted in three human adult cadavers, two of which were submitted to NMR imaging after the device was implanted and the incision closed. Excellent fit was observed in all cadavers, and analysis of the several sagittal, transverse, and coronal NMR images showed no compression of the natural internal structures.