System for implanting a valve prosthesis

A system for replacing the function of an aortic valve in an adult human heart using a catheterization technique and without requiring open heart surgery, comprising:

• a flexible insertion catheter sized for insertion through a small inlet opening and configured for advancement over a guide wire through a body channel;
• a radially compressible and re-expandable metallic stent having a top end, a bottom end and a metallic outer surface configured to directly contact surrounding native tissue in the body channel with a pressure sufficient to prevent detachment from the body channel;
• and
• a radially collapsible and re-expandable valve positioned within an interior portion of the stent and sutured to the stent for folding and expanding together with the stent, the valve having three flaps formed of biological tissue, the three flaps positioned between the top and bottom ends of the stent for allowing blood to flow in one direction such that blood is capable of flowing through the stent from the bottom end toward the top end, the valve having three commissural points sutured to the stent;
• wherein the stent is radially compressible from an expanded condition to a compressed condition, the compressed condition having a compressed outer diameter of less than 12.5 mm to be located inside a tubular wall of a cap along a distal end portion of the insertion catheter for advancement through the small inlet opening into the body channel and wherein the stent is radially re-expandable upon ejection from the cap to a re-expanded condition comprising a re-expanded outer diameter of approximately 27 mm or larger for securing the stent to the surrounding native tissue without suturing the stent to the surrounding native tissue and wherein the insertion catheter is detachable from the stent and valve such that the insertion catheter can be removed from the body channel and the small inlet opening can be closed and wherein the metallic stent has a sufficient height such that the top end of the stent is capable of being positioned downstream of the coronary ostia for anchoring the top end of the stent to the aorta while the valve is positioned substantially between the coronary ostia and a left ventricle of a heart for replacing the function of the natural aortic valve without requiring open heart surgery.

A system for replacing the function of a natural cardiac valve, comprising:

• a flexible elongate delivery catheter having an opening configured to receive a guide wire, the catheter adapted for advancement into a human heart without opening the thoracic cavity;
• and
• a valve prosthesis configured to be coupled to a distal end portion of the delivery catheter, the valve prosthesis comprising:
• a radially compressible and re-expandable stent having a top end, a bottom end and a metallic outer surface configured to contact native tissue in the human heart;
• and
• a collapsible and re-expandable valve structure positioned within an interior portion of the stent and sutured to the stent for collapsing and re-expanding together with the stent, the valve structure having three flaps formed entirely of biological tissue, the three flaps positioned between the top and bottom ends of the stent, the valve structure having three commissural points sutured to the stent, the valve structure configured to allow blood to flow in one direction such that blood enters through a bottom opening at the bottom end of the stent and exits through a top opening at the top end of the stent;
• wherein the valve prosthesis is radially compressible to a compressed state comprising a compressed outer diameter of less than 10 mm for introduction by way of the delivery catheter through an inlet opening into a body channel and wherein the valve prosthesis is radially re-expandable to a re-expanded state comprising a re-expanded outer diameter at least three times larger than the compressed outer diameter and wherein the re-expanded outer diameter is sized to engage native tissue in the human heart with a pressure sufficient for preventing detachment from the human heart and for fixing the valve prosthesis in the human heart without suturing the valve prosthesis to native tissue and wherein the valve prosthesis is detachable from the delivery catheter such that the delivery catheter can be removed from the patient's body and the inlet opening can be closed while the valve prosthesis remains in the human heart.

A system for replacing the function of a defective natural valve in an adult human, comprising:

• an elongate insertion catheter having a central opening configured for receiving a guide wire, the catheter sized for advancement over the guide wire and through a body channel;
• and
• a compressible and re-expandable stent having an inlet end, an outlet end and a metallic outer surface, the stent being radially compressible from an expanded state to a compressed state for introduction through an inlet opening into a body channel along a distal end portion of the insertion catheter, the stent being re-expandable along an entire length of the stent to a re-expanded state such that the metallic outer surface engages surrounding tissue in the body channel, wherein an outer diameter of the stent in the re-expanded state is at least three times larger than an outer diameter of the stent in the compressed state;
• and
• a collapsible and re-expandable valve structure mounted within an interior portion of the stent between the inlet and outlet ends of the stent for folding and expanding together with the stent and configured for preventing blood flow in one direction, the valve structure having movable flaps positioned between the inlet and outlet ends of the stent for allowing blood to flow only from the inlet end toward the outlet end of the stent;
• wherein stent stiffness provides the sole means of fixation to surrounding tissue for securing the stent and valve structure to the body channel and wherein the stent and valve structure are detachable from the catheter such that the catheter can be removed from the body channel and the inlet opening can be closed such that the stent and valve structure are permanently implantable in the body channel for replacing the function of a natural valve without suturing the stent or valve structure to surrounding native tissue.