IP Library Granted Patent US 10,524,901
Granted Patent B2
US 10,524,901 · App. 15/581,949 · Granted Jan 7, 2020

Replacement heart valve

Inventors: Arshad Quadri (West Hartford, CT); J. Brent Ratz (Ladera Ranch, CA); Yen Liao (Arlington, VA); Stan Komatsu (Laguna Hills, CA); Kalathi Thygarajan (Lake Forest, CA); Robrecht Michiels (Laguna Hills, CA); Hung Nguyen (Garden Grove, CA); MyKim Nguyen (Fountain Valley, CA)
Assignee: Edwards Lifesciences CardiAQ LLC
A61F2/2418A61F2/2415A61F2220/0008A61F2230/008A61F2230/0054A61F2230/0067A61F2250/0029A61F2250/0039
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Quick Facts
Patent No.
US 10,524,901
App. No.
15/581,949
Granted
Jan 7, 2020
Kind
B2
Abstract

A replacement heart valve can have an expandable frame configured to engage a native valve annulus. A valve body can be mounted onto the expandable frame to provide functionality similar to a natural valve. The valve body has an upstream end and a downstream end, and a diameter at the downstream end is greater than a diameter at the upstream end.

Claims (46)

1. A mitral valve prosthesis configured to be deployed within a native mitral valve, the prosthesis comprising:

an expandable frame configured to radially expand and collapse for deployment within the native mitral valve, the expandable frame having a proximal end, a distal end, and a transition portion between the proximal and the distal ends, the expandable frame comprising a row of diamond-shaped foreshortening cells configured to foreshorten upon radial expansion of the expandable frame, wherein, in an expanded configuration:

the proximal end has a first cross-sectional dimension;

the distal end has a second cross-sectional dimension greater than the first cross-sectional dimension; and

the transition portion increases in cross-sectional dimension between the first cross-sectional dimension and the second cross-sectional dimension, the transition portion forming a frustoconical shape;

a proximal anchoring portion sized to contact tissue on an atrial side of the native mitral valve when the prosthesis is deployed within the native mitral valve, the proximal anchoring portion comprising a plurality of free apices each connected to the expandable frame at a first base and at a second base, the first base and the second base spaced apart from one another and separated by a gap, the first and the second bases located distal of the proximal end of the expandable frame, wherein, in the expanded configuration, each free apex is positioned radially outwardly from the expandable frame;

a plurality of distal anchors sized to be positioned on a ventricular side of the native mitral valve when the prosthesis is deployed within the native mitral valve, each distal anchor connected to a distal apex of an individual cell of the row of diamond-shaped foreshortening cells, the transition portion positioned between the first and the second bases of the proximal anchoring portion and the distal apices of the individual cell of the row of diamond-shaped foreshortening cells connected to the distal anchor, wherein, in the expanded configuration:

each distal anchor extends from a portion of the expandable frame having a greater cross-sectional dimension than the portion of the expandable frame from which the proximal anchoring portion extends; and

an end of each distal anchor extends proximally and is positioned radially outwardly from the expandable frame; and

a valve body configured to open to allow flow in a direction from the proximal end to the distal end of the expandable frame and close so as to inhibit flow in a direction from the distal end to the proximal end of the expandable frame, the valve body extending along an entire length of the transition portion of the expandable frame, the valve body comprising a valve skirt extending circumferentially around an interior of the expandable frame and a plurality of valve leaflets positioned within the valve skirt,

wherein:

the number of free apices and the number of distal anchors are the same;

the free apices of the proximal anchoring portion are circumferentially offset from ends of the plurality of distal anchors; and

when the prosthesis is deployed within the native mitral valve, a portion of the expandable frame having a cross-sectional dimension greater than the first cross-sectional dimension is configured to engage tissue of the native mitral valve.

2. The prosthesis of claim 1 , wherein the proximal anchoring portion consists of twelve free apices and the plurality of distal anchors consists of twelve distal anchors.

3. The prosthesis of claim 1 , wherein:

the plurality of free apices of the proximal anchoring portion and the plurality of distal anchors extend from the transition portion of the expandable frame;

the plurality of free apices of the proximal anchoring portion are equally circumferentially spaced around the expandable frame; and

the plurality of distal anchors are equally circumferentially spaced around the expandable frame.

4. The prosthesis of claim 1 , wherein the valve body has a frustoconical shape such that a distal end of the valve body has a cross-sectional dimension greater than a cross-sectional dimension of a proximal end of the valve body.

5. The prosthesis of claim 1 , wherein the ends of the distal anchors are curved or rounded.

6. A mitral valve prosthesis configured to be deployed within a native mitral valve, the prosthesis comprising:

an expandable frame configured to radially expand and collapse for deployment within the native mitral valve, the expandable frame having a proximal end, a distal end, and a transition portion between the proximal and the distal ends, the expandable frame comprising a row of foreshortening cells configured to foreshorten upon radial expansion of the expandable frame, wherein, in an expanded configuration:

the proximal end has a first cross-sectional dimension;

the distal end has a second cross-sectional dimension greater than the first cross-sectional dimension; and

the transition portion increases in cross-sectional dimension between the first cross-sectional dimension and the second cross-sectional dimension;

a proximal anchoring portion sized to contact tissue on an atrial side of the native mitral valve when the prosthesis is deployed within the native mitral valve, the proximal anchoring portion comprising a plurality of free apices each connected to the expandable frame at a first base and at a second base, the first base and the second base spaced apparat from one another and separated by a gap, the first and the second bases located distal of the proximal end of the expandable frame, wherein, in the expanded configuration, each free apex is positioned radially outwardly from the expandable frame;

a plurality of distal anchors sized to be positioned on a ventricular side of the native mitral valve when the prosthesis is deployed within the native mitral valve, each distal anchor connected to a distal portion of an individual cell of the row of diamond-shaped foreshortening cells, wherein, in the expanded configuration, an end of each distal anchor extends proximally and is positioned radially outwardly from the expandable frame; and

a valve body configured to open to allow flow in a direction from the proximal end to the distal end of the expandable frame and close so as to inhibit flow in a direction from the distal end to the proximal end of the expandable frame, the valve body extending along an entire length of the transition portion of the expandable frame, the transition portion positioned between the first and the second bases of the proximal anchoring portion and distal ends of the distal anchors, wherein the valve body has a frustoconical shape such that a cross-sectional dimension of a distal end of the valve body is greater than a cross-sectional dimension of the proximal end of the valve body, the valve body comprising a valve skirt extending circumferentially around an interior of the frame and a plurality of valve leaflets positioned within the valve skirt,

wherein, when the prosthesis is deployed within the native mitral valve, a portion of the expandable frame having a cross-sectional dimension greater than the first cross-sectional dimension is configured to engage tissue of the native mitral valve.

7. The prosthesis of claim 6 , wherein the first and the second bases of each of the free apices of the proximal anchoring portion are aligned along an axis parallel to a longitudinal axis of the expandable frame with the ends of the plurality of distal anchors.

8. The prosthesis of claim 6 , wherein the first and the second bases of each of the free apices of the proximal anchoring portion are circumferentially aligned with proximal apices of individual cells of the row of diamond-shaped foreshortening cells.

9. The prosthesis of claim 6 , wherein the free apices of the proximal anchoring portion are circumferentially offset from ends of the plurality of distal anchors.

10. The prosthesis of claim 6 , wherein the plurality of distal anchors extend from distal apices of individual cells of the row of diamond-shaped foreshortening cells.

11. The prosthesis of claim 6 , wherein the first and the second bases are located proximal of the row of foreshortening cells.

12. The prosthesis of claim 6 , wherein the first and the second bases are located along a portion of the expandable frame having a cross-sectional dimension greater than the first cross-sectional dimension.

13. The prosthesis of claim 6 , wherein the prosthesis is configured to be deployed within a native mitral valve and wherein, when the prosthesis is deployed within the native mitral valve, the plurality of distal anchors are sized to extend between chordae tendineae of the native mitral valve.

14. The prosthesis of claim 6 , wherein the plurality of free apices of the proximal anchoring portion and the plurality of distal anchors extend from the transition portion of the expandable frame.

15. The prosthesis of claim 6 , wherein:

the plurality of free apices of the proximal anchoring portion are equally circumferentially spaced around the expandable frame; and

the plurality of distal anchors are equally circumferentially spaced around the expandable frame.

16. The prosthesis of claim 6 , wherein the number of free apices of the proximal anchoring portion and the number of distal anchors are the same.

17. The prosthesis of claim 16 , wherein the proximal anchoring portion consists of twelve free apices and the plurality of distal anchors consists of twelve distal anchors.

18. The prosthesis of claim 6 , wherein a distal anchor extends from each individual cell of the row of diamond-shaped foreshortening cells.

19. The prosthesis of claim 18 , wherein the row of diamond-shaped foreshortening cells consists of twelve individual cells.

20. The prosthesis of claim 6 , wherein the prosthesis is configured to be deployed within a native mitral valve and wherein, when the prosthesis is deployed within the native mitral valve, the proximal end of the expandable frame is configured to be positioned within an atrium.

Assignments (3)
CHANGE OF NAME Recorded Sep 1, 2017
From: EDWARDS LIFESCIENCES CARDIAQ, INC.
To: EDWARDS LIFESCIENCES CARDIAQ LLC
Reel/Frame 043809/0897 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 26, 2017
From: QUADRI, ARSHAD; RATZ, J. BRENT; LIAO, YEN; KOMATSU, STAN; THYGARAJAN, KALATHI; MICHIELS, ROBRECHT; NGUYEN, HUNG; NGUYEN, MYKIM
To: CARDIAQ VALVE TECHNOLOGIES, INC.
Reel/Frame 042819/0025 →
MERGER AND CHANGE OF NAME Recorded Jun 26, 2017
From: IMPALA, INC.; CARDIAQ VALVE TECHNOLOGIES, INC.; CARDIAQ VALVE TECHNOLOGIES, INC.
To: EDWARDS LIFESCIENCES CARDIAQ, INC.
Reel/Frame 042819/0842 →
Continuity (3)
Continuation 13165721 · Jun 21, 2011
Provisional Application 61357048 · Jun 21, 2010
Related Publication 20170231762A1 · Aug 17, 2017
Cited By (9)
US 12,201,521 US 12,290,456 US 12,295,838 US 12,329,635 US 12,403,008 US 12,419,743 US 12,539,209 US 12,558,243 US 12,708,513