Integrated heart valve delivery system

An assembly for replacing a native aortic valve comprising:

• a prosthetic heart valve comprising a radially compressible and expandable metallic stent and a flexible valvular structure mounted within the stent, the prosthetic heart valve comprising an inlet end portion and an outlet end portion;
• and
• a delivery apparatus for implanting the prosthetic heart valve within the native aortic valve in the heart of a patient, the delivery apparatus comprising a handle, a first shaft having a proximal end portion and a distal end portion, a second shaft extending co-axially through the first shaft and having a proximal end portion and a distal end portion, the proximal end portions of the first and second shafts extending distally from the handle, a valve cover coupled to the distal end portion of the first shaft, and a nose piece coupled to the distal end portion of the second shaft;
• wherein the distal end portion of the second shaft extends distally beyond the valve cover such that the nose piece is positioned distal to the valve cover;
• wherein the second shaft comprises a lumen extending along its length, the lumen sized to receive a guidewire;
• wherein the first shaft is moveable axially relative to the second shaft in a proximal direction to move the valve cover proximally relative to the nose piece;
• wherein the second shaft is moveable axially relative to the first shaft in a distal direction to move the nose piece distally relative to the valve cover;
• wherein the prosthetic heart valve is radially crimped around the second shaft with the inlet end portion retained within the nose piece and the outlet end portion retained within the valve cover;
• wherein the delivery apparatus further comprises a manually-operable knob operatively coupled to the proximal end portion of the second shaft and configured to move the second shaft axially relative to the first shaft, and a retaining mechanism configured to selectively retain the second shaft from moving axially relative to the handle and the first shaft.

An assembly for replacing a native aortic valve comprising:

• a prosthetic heart valve comprising a radially compressible and expandable metallic stent and a flexible valvular structure mounted within the stent, the prosthetic heart valve comprising an inlet end portion and an outlet end portion;
• and
• a delivery apparatus for implanting the prosthetic heart valve within the native aortic valve in the heart of a patient, the delivery apparatus comprising a handle, a first shaft having a proximal end portion and a distal end portion, a second shaft extending co-axially through the first shaft and having a proximal end portion and a distal end portion, the proximal end portions of the first and second shafts extending distally from the handle, a valve cover coupled to the distal end portion of the first shaft, and a nose piece coupled to the distal end portion of the second shaft;
• wherein the distal end portion of the second shaft extends distally beyond the valve cover such that the nose piece is positioned distal to the valve cover;
• wherein the second shaft comprises a lumen extending along its length, the lumen sized to receive a guidewire;
• wherein the first shaft is moveable axially relative to the second shaft in a proximal direction to move the valve cover proximally relative to the nose piece;
• wherein the second shaft is moveable axially relative to the first shaft in a distal direction to move the nose piece distally relative to the valve cover;
• wherein the prosthetic heart valve is radially crimped around the second shaft with the inlet end portion retained within the nose piece and the outlet end portion retained within the valve cover;
• wherein the second shaft is placed in tension to hold a proximal end portion of the nose piece against a distal end portion of the valve cover.

An assembly for replacing a native aortic valve comprising:

• a prosthetic heart valve comprising a radially compressible and expandable metallic stent and a flexible valvular structure mounted within the stent, the prosthetic heart valve comprising an inlet end portion and an outlet end portion;
• and
• a delivery apparatus for implanting the prosthetic heart valve within the native aortic valve in the heart of a patient, the delivery apparatus comprising a handle, a first shaft having a proximal end portion and a distal end portion, a second shaft extending co-axially through the first shaft and having a proximal end portion and a distal end portion, the proximal end portions of the first and second shafts extending distally from the handle, a valve cover coupled to the distal end portion of the first shaft, a nose piece coupled to the distal end portion of the second shaft, and an annular tapered wedge disposed in the valve cover;
• wherein the distal end portion of the second shaft extends distally beyond the valve cover such that the nose piece is positioned distal to the valve cover;
• wherein the second shaft comprises a lumen extending along its length, the lumen sized to receive a guidewire;
• wherein the first shaft is moveable axially relative to the second shaft in a proximal direction to move the valve cover proximally relative to the nose piece;
• wherein the second shaft is moveable axially relative to the first shaft in a distal direction to move the nose piece distally relative to the valve cover;
• wherein the prosthetic heart valve is radially crimped around the second shaft with the inlet end portion retained within the nose piece and the outlet end portion retained within the valve cover;
• wherein the nose piece comprises an interior bore and an abutment member disposed within the bore and having an abutment surface engaging the inlet end portion of the prosthetic heart valve to limit axial movement of the prosthetic heart valve within the bore of the nose piece;
• wherein the delivery apparatus further comprises a manually-operable knob operatively coupled to the proximal end portion of the second shaft and configured to move the second shaft axially relative to the first shaft, and a retaining mechanism configured to selectively retain the second shaft from moving axially relative to the handle and the first shaft.