Transapical heart valve delivery system and method
First Claim
1. An off-pump, minimally-invasive surgical method of implanting a prosthetic heart valve to an aortic valve annulus of a patient, comprising, while the patient'"'"'s heart remains beating:
- providing a balloon catheter that includes a balloon on its distal end and a movable pusher having a distal sleeve engaging a proximal end of the balloon providing a balloon-expandable prosthetic heart valve mounted over the balloon on the distal end of the balloon catheter;
creating a puncture through the ventricle wall at or near the apex of the left ventricle of the patient;
inserting an introducer sheath through the puncture;
passing the balloon catheter through the introducer sheath into the left ventricle;
using the pusher and sleeve to advance the balloon and prosthetic heart valve mounted thereon so that the prosthetic heart valve is positioned within the aortic annulus;
proximally displacing the pusher and sleeve with respect to the balloon; and
inflating the balloon to expand the prosthetic heart valve at the aortic annulus.
2 Assignments
0 Petitions
Accused Products
Abstract
A delivery system and method for delivering a prosthetic heart valve to the aortic valve annulus. The system includes a balloon catheter having a steering mechanism thereon for delivering a balloon-expandable prosthetic heart valve through an introducer in an antegrade fashion to the aortic annulus. The balloon catheter passes through an introducer that accesses the left ventricle through its apex and a small incision in the chest wall. The balloon catheter includes a deflecting segment just proximal to the distal balloon to facilitate positioning of the prosthetic heart valve in the proper orientation within the aortic annulus. A slider in a deflection handle may be coupled to a deflection wire that actuates the deflecting segment. The method includes using two concentric rings of purse-string sutures around the puncture in the left ventricular apex to maintain a good seal around instruments passed therethrough. The prosthetic heart valve may be installed over the existing calcified leaflets, and a pre-dilation valvuloplasty procedure may also be utilized.
-
Citations
21 Claims
-
1. An off-pump, minimally-invasive surgical method of implanting a prosthetic heart valve to an aortic valve annulus of a patient, comprising, while the patient'"'"'s heart remains beating:
-
providing a balloon catheter that includes a balloon on its distal end and a movable pusher having a distal sleeve engaging a proximal end of the balloon providing a balloon-expandable prosthetic heart valve mounted over the balloon on the distal end of the balloon catheter;
creating a puncture through the ventricle wall at or near the apex of the left ventricle of the patient;
inserting an introducer sheath through the puncture;
passing the balloon catheter through the introducer sheath into the left ventricle;
using the pusher and sleeve to advance the balloon and prosthetic heart valve mounted thereon so that the prosthetic heart valve is positioned within the aortic annulus;
proximally displacing the pusher and sleeve with respect to the balloon; and
inflating the balloon to expand the prosthetic heart valve at the aortic annulus. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8)
-
-
9. An off-pump, minimally-invasive surgical method of delivering a prosthetic heart valve to an aortic valve annulus of a patient, comprising, while the patient'"'"'s heart remains beating:
-
providing an expandable prosthetic heart valve in an expanded state;
providing a delivery catheter having a distal end;
crimping the expandable prosthetic heart valve to a contracted state over the delivery catheter distal end;
creating an intercostal access opening and exposing the left ventricular apex of the patient;
creating a puncture at or near the apex of the left ventricle;
inserting an introducer sheath through the puncture;
passing the delivery catheter through the introducer sheath and into the left ventricle;
advancing and steering the distal end of the delivery catheter so that the prosthetic heart valve is properly positioned and oriented within the aortic annulus; and
expanding the prosthetic heart valve at the aortic annulus into contact therewith. - View Dependent Claims (10, 11, 12, 13)
-
-
14. A minimally-invasive prosthetic heart valve delivery system, comprising:
-
an introducer sheath having a lumen therethrough of no greater than 24 French;
a balloon catheter having a balloon on a distal end, the balloon catheter further including a steering mechanism for deflecting the distal end; and
a balloon-expandable prosthetic heart valve crimped over the balloon, wherein the outer dimension of the balloon catheter having the prosthetic heart valve thereon is small enough to pass through the introducer sheath lumen. - View Dependent Claims (15, 16, 17, 18, 19, 20, 21)
-
Specification