Patent ID: 7846203

Claim:
A method of replacing a stenotic native aortic valve in a human heart with a prosthetic valve, the prosthetic valve comprising a radially compressible and expandable metallic stent having a substantially circular cross-sectional profile and a flexible valvular structure sewn to the stent, the valvular structure having open and closed positions configured to allow one way flow through the stent, the valvular structure comprising pericardial tissue, the stent comprising intercrossing bars which form zig-zag lines along upper and lower extremities of the stent, the stent constructed to be radially compressible from an expanded size configured for placement within the stenotic native aortic valve to a compressed size having a diameter configured for advancement through a femoral artery leading to the stenotic native aortic valve, the valvular structure positioned entirely between the upper and lower extremities of the stent when the valvular structure is in the closed position, the method comprising: advancing a guide wire through a femoral artery and through an aorta toward a stenotic native aortic valve in a human, heart, the native aortic valve having three valvular leaflets; advancing a distal end portion of a first catheter over the guide wire and through the femoral artery and aorta into the human heart such that an expandable balloon disposed along the distal end portion is positioned within the stenotic native aortic valve; dilating the stenotic native aortic valve by expanding the expandable balloon to push aside the valvular leaflets of the stenotic native aortic valve; deflating the expandable balloon and withdrawing the distal end portion of the first catheter from the human heart; advancing a distal end portion of a second catheter over the guide wire, together with the prosthetic valve disposed along the distal end portion, through the femoral artery and aorta into the human heart such that the prosthetic valve is positioned within the dilated stenotic native aortic valve, the stent being in the compressed size from the expanded size during the advancement; and radially re-expanding the stent, together with the valvular structure, within the dilated stenotic native aortic valve such that the stent intercrossing bars engage each of the three valvular leaflets of the stenotic native aortic valve for maintaining the stenotic native aortic valve in the dilated condition and wherein the valvular structure of the prosthetic valve replaces the valvular function of the stenotic native aortic valve and wherein an internal cover contacts an interior surface of the stent between the lower extremity of the stent and the valvular structure, the internal cover being sewn to the stent and adapted for preventing the passage of blood through spaces between the intercrossing bars of the stent, and wherein the entire aortic valve replacement method is performed without using cardiopulmonary bypass.