Replacement heart valves, delivery devices and methods

• US 9,949,827 B2
• Filed: 05/01/2015
• Issued: 04/24/2018
• Est. Priority Date: 09/29/2009
• Status: Active Grant

• Current Assignee: Edwards Lifesciences CardiAQ LLC (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences CardiAQ LLC (Edwards Lifesciences Corporation)
• Inventors: Quadri, Arshad, Ratz, J. Brent
• Primary Examiner(s): HOLWERDA, KATHLEEN SONNETT
• Application Number:
  US14/702,233
• Publication Number:
  US 20150305864A1
• Time in Patent Office: 1,089 Days
• Field of Search: 623 211
• 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;

a first plurality of anchors extending from the frame; and

a valve body positioned within the frame, the valve body having an inflow end and an outflow end; and

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

wherein, after engaging the tips, the replacement valve is positioned so that;

a portion of the frame, having a larger diameter than an inflow end of the replacement valve, is positioned within the native mitral valve annulus;

an outflow portion of the replacement valve extends distally and bends radially inwardly towards a longitudinal axis of the replacement valve at or proximate an outflow end; and

the portion of the frame within the native mitral valve annulus has a larger cross-sectional dimension than a periphery of the frame adjacent the inflow end of the valve body;

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

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

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

4. The method of claim 1, wherein engaging the tips of the first plurality of anchors with tissue on the ventricular side of the native mitral valve annulus includes moving the replacement valve toward the native mitral valve.

5. The method of claim 4, wherein moving the replacement valve causes the first plurality of anchors to contain the native leaflets.

6. The method of claim 4, wherein moving the replacement valve causes bunching up of the native valve leaflets with the first plurality of anchors.

7. The method of claim 4, wherein moving the replacement valve causes the 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.

8. The method of claim 1, wherein the replacement valve further comprises replacement valve leaflets located in the inflow end of the replacement heart valve.

9. The method of claim 1, wherein positioning the replacement valve so that the tips of the first plurality of anchors are on the ventricular side of the native leaflets beyond a location where chordae tendineae connect to free ends of the native leaflets is performed before releasing at least a portion of the replacement valve from the delivery device.

10. 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

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 the tips of the first plurality of anchors with tissue on the ventricular side of the native mitral valve annulus with the first plurality of anchors extending between at least some of the chordae tendineae, wherein, after engaging the tips, the replacement valve is positioned so that an outflow end of the replacement valve has a larger diameter than an inflow end of the replacement valve;

with the tips of the plurality of first anchors engaging tissue on the ventricular side of the native mitral valve annulus, further releasing the replacement valve from the delivery device and expanding the frame to a radially expanded state, 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 mitral valve annulus;

wherein the tips of the first plurality of anchors and tips of the second plurality of anchors are located downstream of replacement valve leaflets located in the inflow end of the replacement heart valve.

11. The method of claim 10, wherein, after the replacement valve has been delivered to the native mitral valve and expanded, an outflow portion of the replacement valve bends radially inwardly towards a longitudinal axis of the replacement valve at or proximate an outflow end.

12. The method of claim 10, wherein positioning the replacement valve so that the tips of the first plurality of anchors are on the ventricular side of the native leaflets beyond a location where chordae tendineae connect to free ends of the native leaflets is performed before releasing at least a portion of the replacement valve from the delivery device.

13. 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

releasing the first plurality of anchors and at least a downstream portion of the frame from the delivery device such that the first plurality of anchors expand radially outwardly and the downstream portion expands to at least a substantially full extent; and

after the first plurality of anchors expand radially outwardly and the downstream portion expands to at least the substantially full extent, engaging tips of the first plurality of anchors with tissue on a ventricular side of the native mitral valve annulus with the first plurality of anchors extending between at least some of the chordae tendineae;

wherein, after engaging the tips, the replacement valve is positioned so that a portion of the frame, having a larger diameter than an inflow end of the replacement valve, is positioned within the native mitral valve annulus.

14. The method of claim 13, wherein the replacement valve comprises replacement valve leaflets and all of the replacement valve leaflets are located in the left atrium after engaging the tips.

15. The method of claim 13, wherein releasing the first plurality of anchors and at least the downstream portion of the frame from the delivery device comprises retaining at least a portion of an upstream portion of the frame in at least a partially radially compacted state while the first plurality of anchors expand radially outwardly and the downstream portion expands to at least the substantially full extent.

16. The method of claim 13, wherein releasing the first plurality of anchors and at least the downstream portion of the frame from the delivery device comprises retaining an upstream end of the frame in the delivery device in at least a partially radially compacted state while the first plurality of anchors expand radially outwardly and the downstream portion expands to at least the substantially full extent.

17. The method of claim 13, further comprising positioning the replacement valve so that the tips of the first plurality of anchors are on the ventricular side of the native leaflets beyond a location where chordae tendineae connect to free ends of the native leaflets before releasing the first plurality of anchors and at least the downstream portion of the frame from the delivery device.