Granted Patent B2

US 12,343,252 · App. 17/852,220 · Granted Jul 1, 2025

Inventors: Arshad Quadri (West Hartford, CT); J. Brent Ratz (Winchester, MA)

Assignee: Edwards Lifesciences CardiAQ LLC

A61F2/2409A61F2/2418A61F2/243A61F2/2436A61F2/2439A61F2/95A61F2/9522A61F2002/9534A61F2220/0016A61F2220/0033A61F2220/0075A61F2230/0013A61F2250/001

Abstract

Claims (38)

1. A replacement heart valve comprising:

an expandable frame comprising a first portion configured to be positioned in an atrium of the heart, a second portion configured to be positioned inside of a native heart valve annulus, and a third portion configured to be positioned in a ventricle of the heart;

locking features provided on the first portion of the expandable frame to engage with mating features of a delivery device;

a plurality of anchors extending from the third portion of the expandable frame, wherein the plurality of anchors are sized to contact a native heart valve on a ventricular side of the native heart valve annulus, wherein each of the plurality of anchors extends generally toward the first portion of the expandable frame when the expandable frame is in an expanded configuration, and wherein the plurality of anchors are substantially equally spaced around an entire perimeter of the expandable frame;

a liner sub-assembly comprising a first portion that extends along at least a portion of an external surface of the third portion of the expandable frame and a second portion that extends along at least a portion of an internal surface of the expandable frame; and

a valve body attached to the expandable frame, wherein the valve body comprises prosthetic valve leaflets;

wherein the first portion is configured to contact the native heart valve on an atrial side of the native heart valve annulus; and

wherein the replacement heart valve is configured such that, after the replacement heart valve has been delivered to a native heart valve and expanded, the first portion contacts tissue on the atrial side of the native heart valve annulus and at least some of the plurality of anchors contact tissue on the ventricular side of the native heart valve annulus.

2. The replacement heart valve of claim 1 , wherein the plurality of anchors extend radially outward from the third portion of the expandable frame and in a direction substantially parallel with a longitudinal axis of the expandable frame.

3. The replacement heart valve of claim 1 , wherein the plurality of anchors comprise tips having a smooth radius.

4. The replacement heart valve of claim 1 , further comprising eyelets on at least some of the plurality of anchors.

5. The replacement heart valve of claim 1 , wherein the second portion of the expandable frame is flared to provide an anchoring feature on the second portion of the expandable frame.

6. The replacement heart valve of claim 5 , wherein the anchoring feature is a shoulder.

7. The replacement heart valve of claim 1 , wherein the liner sub-assembly comprises a fabric sub-assembly.

8. The replacement heart valve of claim 1 , wherein the liner sub-assembly extends along the second portion of the expandable frame.

9. The replacement heart valve of claim 1 , wherein the expandable frame is made of a self-expanding material.

10. The replacement heart valve of claim 1 , wherein the valve body comprises three prosthetic leaflets.

11. A replacement heart valve comprising:

an expandable frame comprising a longitudinal axis, a first portion configured to be positioned in an atrium of a heart, a second portion configured to be positioned inside of a native heart valve annulus, and a third portion configured to be positioned in a ventricle of the heart, wherein the expandable frame has a collapsed configuration and an expanded configuration;

a plurality of anchors extending from the third portion of the expandable frame, wherein the plurality of anchors are sized to contact a native heart valve on a ventricular side of the native heart valve annulus, wherein each of the plurality of anchors extends generally toward the first portion of the expandable frame when the expandable frame is in the expanded configuration, and wherein each of the plurality of anchors extends in a direction generally parallel to the longitudinal axis of the expandable frame when the expandable frame is in the collapsed configuration;

an outer liner sub-assembly covering at least the third portion of the expandable frame; and

a valve body attached to the expandable frame, wherein the valve body comprises valve leaflets;

wherein the first portion is configured to contact the native heart valve on an atrial side of the native heart valve annulus; and

wherein the replacement heart valve is configured such that, after the replacement heart valve has been delivered to a native heart valve and expanded, the first portion contacts tissue on the atrial side of the native heart valve annulus and at least some of the plurality of anchors contact tissue on the ventricular side of the native heart valve annulus.

12. The replacement heart valve of claim 11 , further comprising locking features provided on the first portion of the expandable frame to engage with mating features of a delivery device.

13. The replacement heart valve of claim 11 , wherein the plurality of anchors extend radially outward from the third portion of the expandable frame and then in a direction substantially parallel with the longitudinal axis of the expandable frame when the expandable frame is in the expanded configuration.

14. The replacement heart valve of claim 11 , wherein the outer liner sub-assembly comprises a fabric sub-assembly.

15. The replacement heart valve of claim 11 , wherein the outer liner sub-assembly extends along the second portion of the expandable frame.

16. The replacement heart valve of claim 11 , wherein the expandable frame is made of a self-expanding material.

17. A replacement heart valve comprising:

an expandable frame comprising a longitudinal axis, a first portion configured to be positioned in an atrium of a heart, and a second portion configured to be positioned inside of a native heart valve annulus, wherein the expandable frame has a collapsed configuration and an expanded configuration;

a plurality of anchors extending from the expandable frame, wherein the plurality of anchors are sized to contact a native heart valve on a ventricular side of the native heart valve annulus, wherein each of the plurality of anchors extends generally toward the first portion of the expandable frame when the expandable frame is in the expanded configuration and each of the plurality of anchors extends in a direction generally parallel to the longitudinal axis of the expandable frame when the expandable frame is in the collapsed configuration; and

a valve body attached to the expandable frame, wherein the valve body comprises valve leaflets;

wherein the first portion is configured to contact the native heart valve on an atrial side of the native heart valve annulus; and

wherein the replacement heart valve is configured such that, after the replacement heart valve has been delivered to a native heart valve and expanded, the first portion contacts tissue on the atrial side of the native heart valve annulus and at least some of the plurality of anchors contact tissue on the ventricular side of the native heart valve annulus.

18. The replacement heart valve of claim 17 , further comprising locking features provided on the first portion of the expandable frame to engage with mating features of a delivery device.

19. The replacement heart valve of claim 17 , wherein the plurality of anchors extend radially outward from the expandable frame and then in a direction substantially parallel with the longitudinal axis of the expandable frame when the expandable frame is in the expanded configuration.

20. The replacement heart valve of claim 17 , further comprising an outer liner sub-assembly that extends along the second portion of the expandable frame.

Assignments (3)

Continuity (7)

References Cited (400)