Soft artificial ventricles for infants and adults, with or without a clamshell

The quick connect system and mechanical disk valves used in total artificial hearts (TAH) are sources of thrombogenesis and blood damage. Our soft TAH, which has no quick connectors, can be squeezed and bent, making it easily implantable, and blood damage is reduced by the use of trileaflet and biflap polyurethane valves. The soft ventricles were made by vacuum forming, after which the pieces were welded together by radiofrequency heat sealing. A rapid clamshell can be pushed and slipped over the soft heart to prevent deformation of the ventricle. Three calves have had the 60 cc soft TAH implanted, both with and without a clamshell. The cardiac outputs were as high as 7 L/min, without a vacuum applied during diastole. Two lambs received the 20 cc TAH (as an acute experiment); it fit and functioned well. One healthy lamb received a 20 cc left ventricular assist device (LVAD) with a pulsating artificial atrium as a survival experiment. The lamb survived for 8 days, after which the device was removed and the lamb returned to the meadow. Thrombosis in the TAH was minimal, and the plasma free hemoglobin values in all the TAH and LVAD experiments were usually lower than 5 mg/dl and often lower than 2 mg/dl.