Prosthetic valve for transluminal delivery

A prosthetic device for replacing a deficient native aortic valve, comprising:

• a metallic, annular support stent having a circular outer profile and collapsible to a delivery diameter sized for advancement through a femoral artery, the support stent comprising:
• a lower portion formed with an expandable mesh construction and configured to expand to a first expanded diameter dimensioned to contact the leaflets of a native aortic valve,
• an upper portion formed with an expandable mesh construction, the upper portion being configured to contact the inner wall of the ascending aorta at a location above the openings of the coronary arteries, the upper portion having a second expanded diameter, and
• a central portion between the lower and upper portions, the central portion being shaped to provide a radial gap between the support stent and the inner wall of the ascending aorta adjacent to the openings of the coronary arteries;
• and
• a collapsible and expandable valve assembly located entirely within an interior portion of the support stent and formed of biological material, the valve assembly sutured to the support stent, the valve assembly having three commissural points for supporting three valve leaflets within the support stent;
• wherein the three leaflets of the valve assembly are configured to open for allowing blood to flow from the left ventricle into the ascending aorta, and wherein the three leaflets of the valve assembly collapse inwardly for blocking a reverse flow of blood and wherein the support stent has an open wall structure downstream of the leaflets for allowing blood to pass through a wall of the support stent from the interior portion of the support stent to the openings of the coronary arteries, and
• wherein the first expanded diameter of the lower portion of the support stent is smaller than the second expanded diameter of the upper portion of the support stent.

A prosthetic device for replacing a deficient native aortic valve, consisting essentially of:

• a collapsible and expandable, annular support stent comprising a nickel-titanium shape memory alloy, the support stent comprising a circular outer profile, a first portion, a second portion, and a central portion extending between the first portion and the second portion, the second portion being downstream from the first portion;
• a collapsible and expandable valve assembly comprising biological material and disposed within an interior of the support stent, the valve assembly comprising an inlet region sutured to the support stent and three commissural points sutured to the support stent, the three commissural points defining three valve leaflets;
• and
• a collapsible and expandable sheath disposed at and sutured to the first portion of the support stent;
• wherein the prosthetic device has a collapsed, delivery state and an expanded, deployed state,
• wherein, in the expanded, deployed state,
• an expanded diameter of the first portion of the support stent is smaller than an expanded diameter of the second portion of the support stent,
• the first portion of support stent is dimensioned to contact the leaflets of the native aortic valve,
• the first portion of the support stent is configured and dimensioned to not substantially deform a neighboring mitral valve,
• the central portion of the support stent defines a radial gap between the support stent and an inner wall of an ascending aorta at a level of the coronary ostia,
• the second portion of the support stent is configured and dimensioned to engage the inner wall of the ascending aorta above the coronary ostia,
• the support stent comprises an open-wall structure downstream of the valve assembly, thereby allowing blood to pass from the interior of the support stent to the coronary ostia, and
• the three leaflets of the valve assembly have an open state that allows a forward flow of blood from the left ventricle into the ascending aorta, and a closed state that blocks a reverse flow of blood, in which the three leaflets are collapsed inwardly, and
• wherein in the collapsed, delivery state, the device is dimensioned for advancement through a femoral artery.