Everting transcatheter valve and methods
Described embodiments are directed toward centrally-opening, leaflet valve devices and systems for transcatheter delivery having a two-piece valve body as well as methods of making and delivering the two-piece valve devices. A transcatheter valve includes a collapsed configuration and an expanded configuration. The transcatheter valve can further include an everted configuration and a non-everted configuration.
1. A method of delivering, via an intravascular procedure, a transcatheter valve including a multi-part frame having a first portion and a second portion, and one or more leaflets coupled to the multi-part frame, the transcatheter valve having a collapsed configuration and an expanded configuration, the method comprising:
positioning the transcatheter valve at an implantation site in the collapsed configuration;
expanding the transcatheter valve;
everting the multi-part frame of the transcatheter valve; and
securing the transcatheter valve at the implantation site; further comprising loading the transcatheter valve onto a distal section of an elongated flexible catheter such that the first portion of the multi-part frame is coaxially, laterally adjacent to an spaced apart from the second portion of the multi-part frame and transcatheter valve is in the collapsed configuration.
2. The method of claim 1 , wherein positioning the transcatheter valve at the implantation site includes delivering the transcatheter valve to a native valve orifice intravascularly.
3. The method of claim 1 , wherein expanding the transcatheter valve includes expanding the transcatheter valve into a native valve orifice.
4. The method of claim 1 , wherein transitioning the transcatheter valve to an everted configuration includes everting the second portion of the multi-part frame into the first portion of the multi-part frame.
5. The method of claim 1 , wherein the first portion of the multi-part frame defines a generally tubular shape and the second portion of the multi-part frame defines a generally annular shape, the first and second portions of the multi-part frame being coupled by a film bridge defining a fold region between the first and seconds portion of the multi-part frame.
6. The method of claim 1 , wherein the first and second portions of the multi-part frame have different stiffnesses.
7. The method of claim 1 , wherein at least one of the first and second portions of the multi-part frame is formed of non-shape memory material.
8. The method of claim 1 , wherein the first portion of the multi-part frame is formed of an open framework operable to be compressed to a collapsed configuration and expanded to an expanded configuration.
9. The method of claim 1 , wherein following securement of the transcatheter valve at the implantation site, the second portion of the multi-part frame is held adjacent to the first portion of the multi-part frame by a spring bias of the second portion of the multi-part frame.