Percutaneous valve prosthesis and system and method for implanting the same

• US 10,350,065 B2
• Filed: 07/27/2016
• Issued: 07/16/2019
• Est. Priority Date: 07/28/2006
• Status: Active Grant

• Current Assignee: Edwards Lifesciences CardiAQ LLC (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences CardiAQ LLC (Edwards Lifesciences Corporation)
• Inventors: Quadri, Arshad
• Primary Examiner(s): Schall, Matthew W
• Application Number:
  US15/221,435
• Publication Number:
  US 20160331532A1
• Time in Patent Office: 1,084 Days
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/006 modular

Abstract

A method for delivering a heart valve prosthesis to a native valve annulus comprises expanding an expandable frame at the native valve annulus and positioning a replacement heart valve within the expandable frame. The expandable frame preferably includes a first anchoring portion that is positioned on a first side of the native valve annulus and a second anchoring portion that is positioned on a second side of the native valve annulus. The first anchoring portion engages tissue on the first side of the native valve annulus and the second anchoring portion engages tissue on the second side of the native valve annulus for securing the expandable frame to the native valve annulus. The replacement heart valve comprises a plurality of leaflets for replacing the function of the native valve.

Claims

1. A method for delivering a two part heart valve prosthesis to a native valve annulus, the method comprising:

delivering a first expandable frame by use of a first delivery catheter to the native valve annulus, the first expandable frame made from a memory metal and comprising a first anchoring portion and a second anchoring portion;

expanding the first expandable frame at the native valve annulus, wherein when the first expandable frame is in an expanded configuration;

the first anchoring portion extends radially outwardly of a longitudinal axis of the first expandable frame and is positioned on a first side of the native valve annulus;

the second anchoring portion extends radially outwardly of a longitudinal axis of the first expandable frame and is positioned on a second side of the native valve annulus; and

the first anchoring portion engages tissue on the first side of the native valve annulus and the second anchoring portion engages tissue on the second side of the native valve annulus to secure the first expandable frame to the native valve annulus;

delivering a replacement heart valve by use of a second delivery catheter to a location adjacent the native valve annulus, the replacement heart valve comprising a second expandable frame made from a memory metal and a tri-leaflet tissue valve mounted within the second expandable frame;

positioning at least a portion of the replacement heart valve within the first expandable frame; and

expanding the second expandable frame and attaching the second expandable frame to an attachment mechanism on the first expandable frame.

2. The method of claim 1, wherein at least a portion of the replacement heart valve is positioned within the first expandable frame after expanding the first expandable frame at the native valve annulus.

3. The method of claim 1, wherein at least a portion of the replacement heart valve is positioned within the first expandable frame before expanding the first expandable frame at the native valve annulus.

4. The method of claim 1, wherein the second expandable frame comprises a snap-on mechanism for attaching the second expandable frame to the attachment mechanism of the first expandable frame.

5. The method of claim 1, wherein the second expandable frame comprises at least one commissural post and the first expandable frame comprises at least one commissural pin, wherein attaching the second expandable frame to the first expandable frame comprises attaching the at least one commissural pin with the at least one commissural post.

6. The method of claim 5, wherein the at least one commissural post is cannulated and wherein attaching the at least one commissural pin with the at least one commissural post comprises receiving the at least one commissural pin within the at least one commissural post.

7. The method of claim 1, wherein positioning at least a portion of the replacement heart valve within the first expandable frame comprises expanding the replacement heart valve.

8. The method of claim 1, wherein the first expandable frame comprises a superior end and an inferior end, wherein after positioning at least a portion of the replacement heart valve within the first expandable frame, at least a portion of the replacement heart valve is positioned past the superior end of the first expandable frame in a superior direction.

9. The method of claim 1, wherein when the first expandable frame is in an expanded configuration, the first anchoring portion extends at least partially towards the first side of the native valve annulus.

10. The method of claim 1, wherein the second anchoring portion comprises a plurality of anchors and wherein at least a portion of at least one of the plurality of anchors extends towards the first anchoring portion.

11. The method of claim 1, wherein the first expandable frame comprises a skirt at an inflow end of the first expandable frame.

12. The method of claim 11, wherein the first expandable frame further comprises a fabric attached to the skirt configured to reduce leakage.

13. The method of claim 1, wherein the first expandable frame self-expands into the expanded configuration at the native valve annulus.

14. The method of claim 1, wherein the second expandable frame of the replacement heart valve self-expands.

15. The method of claim 1, wherein the native valve annulus is a native aortic valve annulus.

16. The method of claim 1, wherein the tri-leaflet tissue valve is made from pig tissue.