Transapical heart valve delivery system and method

• US 20070112422A1
• Filed: 11/16/2005
• Published: 05/17/2007
• Est. Priority Date: 11/16/2005
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Dehdashtian, Mark
• Granted Patent: US 8,764,820 B2
• Time in Patent Office: Days
• US Class Current: 623/2.110
• CPC Class Codes: A61B 2017/22098 Decalcification of valves
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2002/9583 Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes

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.

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.

2. The method of claim 1, further comprising:

placing a first line of purse-string sutures generally in a first circle in one direction defining a perimeter at or near the apex of the left ventricle of the patient, and then placing a second line of purse-string sutures generally in a circle concentric to the first circle but in an opposite direction;

creating a puncture within the perimeter; and

after inserting the introducer sheath through the puncture, cinching the purse-string sutures to create a seal therearound.

3. The method of claim 1, wherein the balloon catheter includes a steering mechanism therein, and further comprising:

steering the balloon catheter with the steering mechanism within the left ventricle to facilitate positioning the prosthetic heart valve within the aortic annulus.

4. The method of claim 3, wherein the balloon catheter comprises a deflecting segment located just proximal to the balloon, the step of steering comprising:

bending the deflecting segment so as to angle the balloon and prosthetic heart valve mounted thereon.

5. The method of claim 4, wherein the pusher sleeve mounts over the deflecting segment, the method further including:

proximally displacing the pusher and sleeve with respect to the deflecting segment prior to inflating the balloon.

6. The method of claim 5, further comprising:

proximally displacing the pusher and sleeve with respect to the deflecting segment prior to bending the deflecting segment.

7. The method of claim 1, further comprising:

leaving the native aortic valve leaflets in place such that inflating the balloon expands the prosthetic heart valve into contact therewith.

8. The method of claim 1, further comprising:

expanding the prosthetic heart valve into contact with a prosthetic heart valve that was previously implanted at the aortic annulus.

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.

10. The method of claim 9, wherein the delivery catheter includes a balloon on its distal end, and the prosthetic heart valve includes a balloon-expandable stent, the step of expanding including:

injecting fluid into the balloon to expand the prosthetic heart valve outward into contact with the aortic annulus.

11. The method of claim 9, further including:

leaving the native aortic valve leaflets in place such that inflating the balloon expands the prosthetic heart valve into contact therewith.

12. The method of claim 9, wherein the delivery catheter comprises a deflecting segment located just proximal to its distal end, the step of steering comprising:

bending the deflecting segment so as to angle the prosthetic heart valve mounted at its distal end thereon.

13. The method of claim 12, wherein the delivery catheter further includes a pusher having a distal sleeve mounted over the deflecting segment, the method further including:

using the pusher and sleeve to advance the distal end of the delivery catheter and prosthetic heart valve mounted thereon; and

proximally displacing the pusher and sleeve with respect to the deflecting segment prior to bending the deflecting segment.

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.

15. The system of claim 14, wherein the steering mechanism includes:

a deflecting segment on the balloon catheter located just proximal to the balloon.

16. The system of claim 15, further including:

a deflection wire attached to a distal end of the deflecting segment and extending through the balloon catheter to a proximal deflection handle.

17. The system of claim 15, further including:

a pusher having a distal sleeve sized to encompass the deflecting segment and a proximal end of the balloon, the pusher being longitudinally movable with respect to the deflecting segment.

18. The system of claim 14, wherein the balloon catheter further includes:

inner and outer balloon inflation tubes attached to opposite ends of the balloon and arrange to concentrically slide with respect one another to alternately elongate and shorten the balloon;

an inner tube handle for displacing the inner balloon inflation tube;

a balloon inflation connector through which the inner balloon inflation tube passes and to which a proximal end of the outer balloon inflation tube attaches; and

a side port opening to a space defined within the balloon inflation connector, the side port adapted for introducing an inflation fluid into the space and into a tubular space between the inner and outer balloon inflation tubes for inflating the balloon.

19. The system of claim 18, further including:

a deflection handle attached just distal to the balloon inflation connector and through which the outer balloon inflation tube passes, the outer balloon inflation tube including a first lumen for passage of the inner balloon inflation tube, and a second lumen; and

a deflection wire connected to an actuator on the deflection handle and passing through the second lumen of the outer balloon inflation tube to a distal end of the balloon catheter.

20. The system of claim 14, wherein the balloon catheter has a working length sized to fit into the introducer of no more than about 24 inches (61 cm).

21. The system of claim 20, wherein the introducer has a total length of no more than about 13 inches (33 cm).