Method of Manufacturing a Prosthetic Valve

A method of manufacturing a prosthetic heart valve assembly, comprising:

• forming a metallic frame having upper and lower extremities, the frame comprising intersecting bars having diameters in the range of 0.1 to 0.6 mm, the frame being collapsible to a compressed external diameter suitable for advancement through a patient's vasculature and into a native aortic valve using a catheterization technique, the frame being expandable for embedding the frame within the native aortic valve, the frame being capable of resisting the recoil forces of the native aortic valve;
• constructing a valvular structure from pericardial tissue, the valvular structure adapted for permitting blood flow in one direction;
• constructing an internal cover from pericardial tissue, the internal cover forming a sleeve;
• suturing an upper end of the internal cover to a lower end of the valvular structure;
• suturing the valvular structure to the intersecting bars of the frame while the frame is in an expanded state, the valvular structure sutured to the frame with stitches extending around the bars of the frame between the upper and lower extremities;
• and
• suturing the internal cover to the intersecting bars of the frame, the internal cover positioned between the lower extremity of the frame and the valvular structure such that the internal cover covers an internal surface only along an inferior portion of the frame;
• wherein the internal cover is configured to prevent the passage of blood through spaces between the intersecting bars of the frame below the valvular structure.