SYSTEM AND METHOD FOR TRANSAORTIC DELIVERY OF A PROSTHETIC HEART VALVE

• US 20140330366A1
• Filed: 03/17/2014
• Published: 11/06/2014
• Est. Priority Date: 03/15/2013
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Dehdashtian, Mark, Jimenez, Teodoro S.
• Granted Patent: US 10,149,757 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• 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 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2433 using balloon catheter

Abstract

A delivery system and method for delivering a prosthetic heart valve to the aortic valve annulus via a transaortic approach. The system includes a balloon catheter for delivering a balloon-expandable prosthetic heart valve through an introducer from an approach from outside the patient, through a minimally-invasive opening in the chest cavity through an incision in the aorta, and into the aorta and aortic annulus. The balloon catheter includes a flexible, tapered tip just distal of the balloon to facilitate positioning of the prosthetic heart valve in the proper orientation within the aortic annulus. The prosthetic heart valve may be installed over the existing calcified leaflets, and a pre-dilation valvuloplasty procedure may also be utilized.

Claims

1. A minimally-invasive prosthetic heart valve delivery system, comprising:

an introducer sheath with a lumen therethrough;

a balloon catheter having a distal end with a balloon thereon, the balloon having a prosthetic-valve receiving portion, wherein the prosthetic-valve receiving portion is configured to have a radially expandable prosthetic heart valve crimped thereon; and

a radially-expandable prosthetic heart valve comprising a support stent and a valve portion, wherein the radially-expandable prosthetic heart valve is configured to be crimped over the balloon;

wherein the balloon catheter comprises a tapered distal tip positioned on the balloon catheter distally of the prosthetic-valve receiving portion, wherein the tapered distal tip tapers from a maximum diameter of 4 mm to 10 mm to a distal end diameter of 2 mm or less, and wherein the outer dimension of the balloon catheter having the prosthetic heart valve thereon is small enough to pass through the introducer sheath lumen.

2. The system of claim 1, wherein the balloon catheter has a working length sized to fit into the introducer of no more than about 24 inches (61 cm).

3. The system of claim 1, wherein the introducer has a total length of no more than about 13 inches (33 cm).

4. The system of claim 1, wherein the lumen of the introducer has a diameter of no greater than 24 French.

5. The system of claim 1, wherein the tapered distal tip comprises a length of 10 mm to 40 mm between the maximum diameter and the distal end diameter.

6. The system of claim 1, wherein the tapered distal tip comprises a curved distal portion passing through an angle of approximately 60 to 120 degrees.

7. The system of claim 6, wherein the curved distal portion passes through an angle of about 90 degrees.

8. The system of claim 1, wherein the tapered distal tip comprises a concave tapered surface at a forward-facing portion of the tapered distal tip.

9. A method of implanting a prosthetic heart valve to an aortic valve annulus of a patient, comprising:

providing a balloon catheter that includes a balloon on its distal end and a tapered tip distal of the balloon, wherein the tapered tip tapers from a minimum diameter at a distal end thereof to a maximum diameter proximally of the distal end, and wherein the tapered tip is substantially flexible with increased flexibility toward the distal end thereof and reduced flexibility proximal of the distal tip;

providing a balloon-expandable prosthetic heart valve mounted over the balloon on the distal end of the balloon catheter;

creating a puncture in the aortic wall at or near the aortic arch of the patient;

inserting an introducer sheath through the puncture;

passing the balloon catheter through the introducer sheath into the aorta;

advancing the balloon catheter through the aortic annulus and thereby engaging the tapered tip distally against one or more leaflets of the resident aortic valve, wherein the balloon catheter is advanced until the balloon-expandable prosthetic heart valve is positioned within the aortic annulus;

inflating the balloon to expand the balloon-expandable prosthetic heart valve at the aortic annulus;

wherein all portions of this method are performed while the patient'"'"'s heart remains beating.

10. The method of claim 9, further comprising:

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

11. The method of claim 9, further comprising:

prior to creating the puncture in the aortic wall, placing a line of purse-string sutures generally in a circle defining a perimeter on the aortic wall of the patient;

wherein creating the puncture in the aortic wall comprises creating a puncture within the perimeter defined by the line of purse-string sutures; and

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

12. The method of claim 9, the distal tip comprises a curved portion with an outer curved surface, and wherein advancing the balloon catheter through the aortic annulus and thereby engaging the tapered tip distally against one or more leaflets of the resident aortic valve comprises engaging the outer curved surface of the curved portion against one or more leaflets of the resident aortic valve.

13. The method of claim 9, wherein the resident aortic valve is a native aortic valve.

14. The method of claim 9, wherein the resident aortic valve is a prosthetic aortic valve.

15. A method of implanting a prosthetic heart valve at a valve annulus of a patient, wherein a resident heart valve is positioned at the valve annulus, comprising:

providing a balloon catheter that includes a balloon on its distal end and a tapered tip distal of the balloon, wherein the tapered tip tapers along a length of 10 mm to 40 mm from a minimum diameter of 2 mm or less at a distal end thereof to a maximum diameter of 4 mm to 10 mm proximally of the distal end, and wherein the tapered tip is substantially flexible with increased flexibility toward the distal end thereof and reduced flexibility proximal of the distal tip;

providing a balloon-expandable prosthetic heart valve mounted over the balloon on the distal end of the balloon catheter;

inserting an introducer sheath into the patient to a position adjacent the resident heart valve;

passing the balloon catheter through the introducer sheath toward the resident heart valve;

advancing the balloon catheter through the valve annulus and thereby engaging the tapered tip distally against one or more leaflets of the resident valve, wherein the balloon catheter is advanced until the balloon-expandable prosthetic heart valve is positioned within the valve annulus;

inflating the balloon to expand the balloon-expandable prosthetic heart valve at the valve annulus;

wherein all portions of this method are performed while the patient'"'"'s heart remains beating.

16. The method of claim 15, wherein the tapered tip comprises a curved portion with an outer curved surface, and wherein advancing the balloon catheter through the valve annulus and thereby engaging the tapered tip distally against one or more leaflets of the resident valve comprises engaging the outer curved surface of the curved portion against one or more leaflets of the resident valve.

17. The method of claim 15, wherein the tapered tip comprises a concave tapered surface, and wherein advancing the balloon catheter through the valve annulus and thereby engaging the tapered tip distally against one or more leaflets of the resident valve comprises engaging the concave tapered surface of the tapered tip against one or more leaflets of the resident valve.

18. The method of claim 15, wherein the resident valve is an aortic valve.

19. The method of claim 15, wherein the resident valve is a native valve.

20. The method of claim 15, wherein the resident valve is a prosthetic valve.