PERCUTANEOUSLY DELIVERABLE HEART VALVE AND METHODS ASSOCIATED THEREWITH
An assembly configured for replacing an aortic or pulmonary heart valve in a human patient includes a transcatheter, prosthetic aortic or pulmonary heart valve. The transcatheter, prosthetic hear valve includes a frame that is expandable and collapsible, a tissue leaflet assembly sutured directly to the frame. The assembly also includes a percutaneously insertable valve delivery mechanism, wherein the transcatheter, prosthetic heart valve is releasably and coaxially mounted onto a balloon catheter of the percutaneously insertable valve delivery mechanism. The balloon catheter includes a guidewire lumen. The transcatheter, prosthetic heart valve releasably and coaxially mounted onto the balloon catheter are included in a sterile packaging to form the assembly.
1 .- 6 . (canceled)
7 . An assembly configured for replacing an aortic or pulmonary heart valve in a human patient, comprising:
a transcatheter, prosthetic aortic or pulmonary heart valve, including:
a frame that is expandable and collapsible; and
a tissue leaflet assembly sutured directly to the frame, wherein the tissue leaflet assembly includes three substantially dry leaflets that each include a free edge that has a curved profile configured to increase total surface area between coapting leaflets, wherein a single piece of treated mammalian pericardial tissue is used to form the three substantially dry leaflets, the mammalian pericardial tissue being treated with glutaraldehyde and glycerol and having a thickness of between about 50 to 300 μm,
wherein the frame and the tissue leaflet assembly are collapsible as an integral unit such that a cell structure of the frame and an orientation of the leaflets of the tissue leaflet assembly are maintained during a collapsing of the transcatheter, prosthetic aortic or pulmonary heart valve;
a percutaneously insertable valve delivery mechanism, wherein the transcatheter, prosthetic aortic or pulmonary heart valve is releasably and coaxially mounted onto a balloon catheter of the percutaneously insertable valve delivery mechanism, wherein the balloon catheter has a size of 12 to 14 French, and wherein the balloon catheter includes a guidewire lumen; and
a sterile package containing the transcatheter, prosthetic aortic or pulmonary heart valve that is releasably and coaxially mounted onto the balloon catheter.
8 . The assembly of claim 7 , wherein the frame comprises a stent.
9 . The assembly of claim 7 , wherein the treated mammalian pericardial tissue has an ultimate tensile strength of greater than about 12 MegaPascals.
10 . The assembly of claim 7 , wherein the treated mammalian pericardial tissue does not include a matrix that has been exposed to a polymer infiltrate.
11 . The assembly of claim 7 , wherein the treated mammalian pericardial tissue has been treated with distilled water.
12 . The assembly of claim 7 , wherein the treated mammalian pericardial tissue has been treated with isopropyl alcohol.
13 . The assembly of claim 7 , wherein the tissue leaflet assembly comprises two or more integrated cusp and leaflet folded structures that each include a mobile leaflet section and a cuff wall section located radially outside the mobile leaflet section such that in a closed position at least a portion of free edges of the mobile leaflet sections are in contact with each other.
14 . The assembly of claim 7 , wherein the tissue leaflet assembly comprises one or more pleats that are sutured to the frame.
15 . The assembly of claim 7 , wherein the cuff section extends longitudinally beyond the free edges of the mobile leaflet sections.