Method for replacement of heart valve

A method for implanting a replacement heart valve within an insufficient native valve using a minimally invasive procedure that does not require extracorporeal cardiopulmonary bypass, the method comprising:

• advancing a guidewire into a patient's heart;
• advancing a valve delivery device over the guidewire into the patient's heart, the valve delivery device having the replacement heart valve disposed along a distal end portion thereof, the replacement heart valve comprising at least three leaflets made from pericardium, a collapsible and expandable stent frame made from a shape memory material, and a fluid-tight membrane formed from a single piece of material, which entirely and continuously encircles an outer perimeter of the leaflets, the fluid-tight membrane positioned between the leaflets and the stent frame, the fluid-tight membrane extending radially outwardly from the leaflets and having an inner circumferential edge that circumscribes the leaflets and an outer circumferential edge spaced radially outwardly from the inner circumferential edge;
• and
• radially expanding the replacement heart valve from a collapsed state to an expanded state in the insufficient native valve;
• wherein the stent frame self-expands to a diameter that conforms to an annulus of the insufficient native valve while the leaflets expand to a fixed diameter defined by a central opening in the fluid-tight membrane, wherein the fixed diameter of the leaflets is smaller than the annulus of the insufficient native valve such that an annular space exists between the leaflets and the stent frame and wherein the fluid-tight membrane fills the space;
• and
• wherein the replacement heart valve is implanted within the insufficient native valve without performing a sternotomy and without using extracorporeal cardiopulmonary bypass.