METHODS OF VALVE DELIVERY ON A BEATING HEART

摘要

A delivery system and method for delivering a prosthetic heart valve to the aortic valve. The system includes a delivery catheter having a steering mechanism thereon for delivering a balloon-expandable prosthetic heart valve to the aortic valve through an introducer passing into the left ventricle through its apex. The introducer may have a more floppy distal section than a proximal section to reduce trauma to the heart wall while preserving good operating field stability. The delivery catheter includes a deflecting segment just proximal to a distal balloon to facilitate positioning of the prosthetic heart valve in the proper orientation. A trigger in a catheter handle may be coupled to a deflection wire that actuates the deflecting segment, while a slider in the handle controls retraction of a valve pusher. The prosthetic heart valve may be installed over the existing calcified leaflets, and a pre-dilation valvuloplasty procedure may also be utilized.

主权项

1. A method of deploying and implanting a prosthetic heart valve into a beating heart, comprising:
while the heart is beating, forming an incision and passing an introducer having a stiff proximal section and a more flexible distal section terminating in a distal end into the left side of the heart, wherein the stiff proximal section extends substantially straight out of the body and the distal section is located within the heart so as to provide a direct-access approach lumen; advancing a balloon catheter having a prosthetic heart valve mounted on a distal balloon through and beyond the distal end of the introducer such that the prosthetic heart valve is positioned within the existing aortic valve, the balloon catheter having a proximal control handle on which is mounted a deflection actuator for deflecting the balloon and the prosthetic heart valve relative to a proximal section of the catheter; moving the deflection actuator to deflect the balloon catheter and the prosthetic heart valve relative to the existing aortic valve; and inflating the balloon to expand the prosthetic heart valve against the existing aortic valve.