Replacement heart valves, delivery devices and methods

• US 9,023,100 B2
• Filed: 01/31/2013
• Issued: 05/05/2015
• Est. Priority Date: 09/29/2009
• Status: Active Grant

• Current Assignee: Edwards Lifesciences CardiAQ LLC (Edwards Lifesciences Corporation)
• Original Assignee: Cardiaq Valve Technologies Incorporated
• Inventors: Quadri, Arshad, Ratz, J. Brent
• Primary Examiner(s): HOLWERDA, KATHLEEN SONNETT
• Application Number:
  US13/756,424
• Publication Number:
  US 20130144381A1
• Time in Patent Office: 824 Days
• Field of Search: 623 21- 219, 623/1.11, 623/1.12
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0041 using additional screws, bolts, dowels or rivets, e.g. connecting screws
• CPC Class Codes: A61F 2220/0066 stapled
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/008 paraboloidal

Abstract

A replacement heart valve and method of treating valve insufficiency includes an expandable frame configured to engage a native valve annulus. A valve body is coupled to the frame. The valve body can include a leaflet portion and possibly a skirt portion. A portion of the frame has a foreshortening portion configured to longitudinally expand when urged to a radially compacted state and longitudinally contract when urged to a radially expanded state. In one embodiment the valve skirt is attached to the frame so that it can adapt to changes in the length of the frame. A delivery device in some embodiments can use one or more coverings, such as sheaths, to controllably release the replacement heart valve at a native heart valve.

Claims

1. A method of delivering a replacement valve to a native mitral valve and securing the replacement valve relative to the native mitral valve annulus, the native mitral valve annulus supporting native leaflets, the method comprising:

delivering a replacement valve mounted on a delivery device to the native mitral valve annulus while the replacement valve is in a radially compacted state, the replacement valve comprising a radially expandable frame and a first plurality of anchors extending from the frame and the delivery device comprising;

a first elongate member comprising a proximal end and a distal end;

an inner retention ring positioned over the first elongate member, wherein the replacement valve is configured to be connected to the inner retention ring;

a support tube configured to be slidable over the first elongate member and the inner retention ring;

a second elongate member configured to be slidable over the first elongate member and the support tube; and

a third elongate member configured to be slidable over the second elongate member and the replacement valve;

positioning the replacement valve so that tips of the first plurality of anchors are on a ventricular side of the native leaflets beyond a location where chordae tendineae connect to free ends of the native leaflets;

releasing at least a portion of the replacement valve from the delivery device to thereby expand the first plurality of anchors radially outwardly; and

engaging tips of the first plurality of anchors with tissue on a ventricular side of the native valve annulus with the first plurality of anchors extending between at least some of the chordae tendineae.

2. The method of claim 1, further comprising, with tips of the plurality of first anchors engaging tissue on the ventricular side of the native valve annulus, further releasing the replacement valve from the delivery device and expanding the frame to a radially expanded state.

3. The method of claim 2, wherein further releasing the replacement valve causes a second plurality of anchors extending from the frame to engage tissue on an atrial side of the native valve annulus.

4. The method of claim 1, wherein tips of the first plurality of anchors engage a ventricular side of the native mitral valve annulus.

5. The method of claim 1, wherein tips of the first plurality of anchors engage a ventricular side of the native mitral valve annulus and the native valve leaflets.

6. The method of claim 1, comprising, after releasing at least a portion of the replacement valve from the delivery device, moving the replacement valve toward the native mitral valve so that tips of the plurality of first anchors engage tissue on a ventricular side of the native mitral valve annulus.

7. The method of claim 6, wherein moving the replacement valve causes the first plurality of anchors to contain the native leaflets.

8. The method of claim 6, wherein moving the replacement valve causes bunching up of the native valve leaflets with the first plurality of anchors.

9. The method of claim 6, wherein moving the replacement valve causes tips of the first plurality of anchors to engage a posterior leaflet side of the annulus prior to engaging an anterior leaflet side of the annulus.

10. The method of claim 1, wherein the radially expandable frame comprises a first end and a second end and a first portion and a second portion, the first portion being closer to the first end than the second portion is to the first end and the second portion being closer to the second end than the first portion is to the second end.

11. The method of claim 10, wherein the second end of the replacement valve is connected to the inner retention ring.

12. The method of claim 1, wherein proximal retraction of the support tube relative to the inner retention ring disconnects the frame from the inner retention ring.

13. The method of claim 1, wherein releasing at least a portion of the replacement valve from the delivery device to thereby expand the first plurality of anchors radially outwardly comprises proximally retracting the third elongate member relative to the replacement valve.

14. The method of claim 13, wherein releasing at least a portion of the replacement valve from the delivery device to thereby expand the first plurality of anchors radially outwardly further comprises proximally retracting the second elongate member relative to the replacement valve.

15. The method of claim 1, wherein the support tube comprises a ring.

16. The method of claim 1, wherein the support tube comprises an elongate member.

17. The method of claim 1, wherein the first elongate member further comprises a lumen configured to slidably accommodate a guidewire.

18. The method of claim 1, wherein the delivery device comprises a nose cone at the distal end of the first elongate member, and the replacement valve is delivered to the native mitral valve annulus with the replacement valve positioned within the third elongate member and a distal end of the third elongate member positioned over a portion of the nose cone.