Methods for replacing a native heart valve and aorta with a prosthetic heart valve and conduit

摘要

A medical device includes an expandable conduit, a prosthetic heart valve and a delivery device, including a balloon catheter. The expandable conduit may include one or more inner or outer sleeves supported by a frame or stent. The sleeve(s) may be a bioprosthetic tissue wrapped, molded or sewn about the frame or stent. Coupled to an end of the expandable conduit is the prosthetic heart valve. The conduit and heart valve may be crimped on the balloon catheter for percutaneous deployment. The frame may be constructed of a balloon-expandable material for the conduit portion and a self-expandable material for the prosthetic heart valve portion. The prosthetic heart valve is anchored at the native heart valve and then the conduit to be expanded into place to protect the aorta. The self-expanding prosthetic heart valve avoids the need for balloon mounting. This provides for a smaller diameter and easier delivery.

主权项

1. A method, comprising:
delivering with a sheath a balloon-expandable conduit into an ascending aorta extending from a native aortic heart valve, the balloon-expandable conduit being coupled in series to a self-expandable prosthetic heart valve having flexible leaflets to form a valved conduit, wherein the balloon-expandable conduit and the self-expandable prosthetic heart valve are both supported by a common stent contiguously formed of Nitinol, and simultaneously positioning the self-expandable prosthetic heart valve within the native aortic heart valve; retracting the sheath from around the balloon-expandable conduit and self-expandable prosthetic heart valve so that the prosthetic heart valve expands into a functional form with the native aortic heart valve; and inflating a balloon disposed within the balloon-expandable conduit such that the balloon-expandable conduit expands into a functional form and an outer surface thereof contacts the ascending aorta.