Multi-frame prosthetic valve apparatus and methods

摘要

Described embodiments are directed toward centrally-opening leaflet prosthetic valve devices having a leaflet frame coaxially disposed within a body frame, as well as methods of making the valve devices. A method of making a multi-frame prosthetic valve (100) comprises: providing a body frame (120) defining a generally tubular shape defining a body frame lumen; providing a leaflet frame (130) having a generally annular shape defining a plurality of U-shaped portions each defining a base and a plurality of posts; providing a film; forming a first layer of the film into a tubular form; coaxially placing the leaflet frame over the tubular form of the first layer of film; wrapping the film around the leaflet frame and the tubular form of the first layer of film, the film extending across each of the U-shaped portions so as to define a leaflet (140) therein; bonding the first layer and the second layer to each other and the leaflet frame; clamping the leaflets disposed in the U-shaped portions to enclose the leaflets; forming a third layer of the film over the leaflet frame; placing the body frame over the third layer of the film and over the leaflet frame such that the leaflet frame is coaxially disposed within the body frame lumen forming a fourth layer of the film over the body frame and the third layer of the film; and bonding the third layer and the fourth layer to each other and the body frame.