Heart disease is the leading cause of death in the U.S., killing approximately 750,000 annually. The proposed non-blood contacting, temporary ventricular support system is complementary, not competitive, with VADs and replacement hearts. Reduced risk of embolism and infection allows it to fill the gap between existent treatment options. The cuff's collapsible construction permits implantation without disruption of the sternum. Intended to be fully reversible, it offers a safe, cost-effective therapeutic option that can support a failing heart until recovery or other therapies are performed. The immediate goal is to demonstrate that a shape memory actuator based system can support a failing heart. The system is intended to be safer and more reliable than pneumatically driven devices. Direct conversion of electrical energy to mechanical work eliminates the risk of aneurization. The indwelling cuff follows heart motion without displacing other organs. Redundant actuator layers enhance reliability without increasing cuff volume. The elimination of bulky pneumatic drivelines reduces infection risk. Consisting of a small, quiet console linked to an indwelling cuff by a single l6F line, the system provides a therapeutic option in applications involving MI, congestive heart failure, emergency tsransport, post cardiotomy support, and bridge to transplantation.
In 1997 approximately 10% of the estimated $80 billion medical device market was due to sales of cardiovascular devices. The treatment of heart failure is the largest consumer of healthcare dollars in the U.S. There is a need for a less-invasive, easily reversible, but effective therapy, as a cost- effective method of supporting patients until either native heart function recovers or the patient's clinical condition is deemed appropriate for more long-term or permanent support.
