Method for delivery of prosthetic aortic valve

Abstract

Methods of delivering a prosthetic aortic heart valve are disclosed. The disclosed methods include loading a prosthetic aortic valve in a collapsed configuration into a delivery sheath so that a selected point on the prosthetic valve is rotationally aligned relative to a long axis of the delivery sheath with a selected radiopaque marker on the delivery sheath, while under fluoroscopic imaging, rotating the delivery sheath about its long axis to align a selected radiopaque marker on the delivery sheath with the selected point on the native aortic valve in a fluoroscopic imaging plane, thereby establishing a desired orientation of the prosthetic aortic valve with respect to the native aortic valve in which the prosthetic valve commissures are rotationally aligned with commissures of the native aortic valve, further advancing the delivery sheath along its long axis until the prosthetic aortic valve is disposed inside the native aortic valve, and deploying the prosthetic aortic valve into an implanted state inside the native aortic valve with the prosthetic aortic valve aligned in the desired orientation with respect to the native aortic valve.

1 . A method of implanting a prosthetic aortic valve in a native aortic valve of patient with a delivery sheath, the prosthetic aortic valve including a stent frame having an interior and three prosthetic valve leaflets mounted within the interior and joined at three respective commissures to provide unidirectional flow of blood through the prosthetic aortic valve, the method comprising:
 collapsing the prosthetic aortic valve into a collapsed configuration;   loading the prosthetic aortic valve in the collapsed configuration into the delivery sheath;   introducing the delivery sheath along a long axis of the delivery sheath into a vasculature of the patient;   advancing the delivery sheath through the vasculature of the patient towards an ascending aorta of the patient and the native aortic valve;   before any portion of the prosthetic aortic valve is in an annulus of the native aortic valve, fluoroscopically imaging the distal portion of the delivery sheath, the prosthetic aortic valve and the native aortic valve with a fluoroscopic camera;   after the advancing the delivery sheath, and while under the fluoroscopic imaging, rotating the delivery sheath about its long axis to align the prosthetic aortic valve with the native aortic valve, thereby establishing a desired orientation of the prosthetic aortic valve with respect to the native aortic valve in which the prosthetic valve commissures are rotationally aligned with commissures of the native aortic valve;   after the rotating the delivery sheath, further advancing the delivery sheath along its long axis until the prosthetic aortic valve is disposed inside the annulus of the native aortic valve; and   deploying the prosthetic aortic valve into an implanted state inside the annulus of the native aortic valve with the prosthetic aortic valve aligned in the desired orientation with respect to the native aortic valve.   
     
     
         2 . The method of  claim 1 , wherein the rotating the delivery sheath is a second rotating, and further comprising, before the further advancing the delivery sheath, initially rotating the delivery sheath towards the desired orientation to reduce the amount of rotation required during the second rotating. 
     
     
         3 . The method of  claim 1 , further comprising, before the introducing, placing the prosthetic aortic valve mounted in the delivery sheath into an introducer sheath with the long axis of the delivery sheath in a rotational orientation relative to the introducer sheath that ensures the prosthetic aortic valve will be at least substantially aligned in the desired orientation after the advancing. 
     
     
         4 . The method of  claim 1 , wherein the delivery sheath includes a radiopaque marker, and wherein the loading the prosthetic aortic valve includes rotationally aligning a selected point on the prosthetic valve with the radiopaque marker of the delivery sheath. 
     
     
         5 . The method of  claim 1 , wherein the prosthetic aortic valve includes a radiopaque marker, and wherein the rotating the delivery sheath includes aligning the radiopaque marker with a selected point on the native aortic valve. 
     
     
         6 . The method of  claim 5 , wherein the selected point on the native aortic valve is one of a commissure, a cusp, a nadir of a cusp, or a coronary artery. 
     
     
         7 . The method of  claim 1 , wherein the stent frame further including a portion at a lower edge thereof, and wherein the deploying the prosthetic aortic valve includes deploying the prosthetic aortic valve with the portion of the stent frame disposed adjacent to the location of conduction tissue of the native aortic valve so that the frame does not damage the conduction tissue. 
     
     
         8 . The method of  claim 7 , wherein the portion includes a cut-out, recess, or opening. 
     
     
         9 . The method of  claim 1 , wherein the advancing the delivery sheath includes disposing the distal end of the delivery sheath in the ascending aorta with the entire prosthetic aortic valve in a position above the native aortic valve, and wherein the rotating the delivery sheath is performed while the prosthetic aortic valve is in the position above the native aortic valve. 
     
     
         10 . The method of  claim 1 , wherein the stent frame includes a portion at a lower edge thereof, the portion of the stent frame being configured to avoid high pressure contact against the conduction tissue.