DEVELOPMENT OF A TOTALLY IMPLANTABLE ELECTROMECHANICAL TOTAL ARTIFICIAL-HEART - BAYLOR TAH

A totally implantable, one-piece, electromechanical total artificial heart (TAH) intended for permanent human use has been developed. It consists of left and right pusher-plate pumps (63 cc design stroke volume) sandwiching a thin center piece with a compact electromechanical actuator. The pusher-plates are shaped conically to accommodate an actuator in the space between them. The actuator consists of an efficient and durable planetary roller screw and direct current brushless motor. The left master alternate pumping mode was implemented utilizing the left pump pusher-plate position signal. The blood-contacting surface was coated with a dry gelatin to yield long-term clot-free performance. Trileaflet tissue valves of 27 and 23 mm are used in the inflow and outflow ports. The diameter and thickness of the TAH are 97 and 82 mm, the overall volume is 510 cc, and the weight is 620 g. Anatomic fit was confirmed in 26 heart transplant recipients (body weight 78 kg and surface area 2 m2) without compressing adjacent organs. The pump performance study revealed that the TAH can yield outputs of 3-8 L/min against the 100 mm Hg afterload with 1-10 mm Hg filling pressure. The input power to the motor ranged from 7 to 12 W. with an efficiency of 18% to 14%. A one-week in vivo calf study demonstrated adequate performance of the TAH, particularly the regulation of atrial pressures. Good anatomic fit and good biocompatibility were also demonstrated.