Apical-Ventricular Cannula for Aortic Valve Bypass Therapy

A growing number of elderly patients with significant co-morbidities do not meet the inclusion criteria for conventional cardiac surgical therapies, including aortic valve replacement and mechanical circulatory support. To meet this clinical need, an aortic valve bypass (AVB) system is being developed that may be implanted using subcostal or mini-thoracotomy surgical approaches without ventricular coring or cardiopulmonary bypass. The AVB system consists of an apical left ventricular (ALV) cannula made from pyrolytic carbon, a valved conduit with a locking mechanism, and a Nitinol clip for anastomosis to the descending aorta. To define design criteria and demonstrate efficacy, ALV cannulae with different diameters (7–14 mm), number of sideholes (6–12), sidehole size (1.9–4.6 mm wide) and tip shapes (tapered, straight) were designed, fabricated, and tested. Cannula efficacy was determined by quantifying flow rates and pressure drops across the ALV cannula using steady-state and dynamic mock circulation models simulating mild, moderate and severe aortic stenosis test conditions. Blood trauma testing was conducted to demonstrate hemocompatibility using the smallest diameter (7 mm) ALV cannula prototype fabricated from pyrolytic carbon (PYC). In vitro and blood trauma testing demonstrated that (1) the 7 mm PYC cannula did not produce significant hemolysis (4.5 L/min for