Prosthetic valve for replacing a mitral valve

• US 10,687,939 B2
• Filed: 06/21/2018
• Issued: 06/23/2020
• Est. Priority Date: 06/06/2014
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Cooper, Alexander H., Peterson, Matthew A., Brunnett, William C.
• Primary Examiner(s): Stewart, Alvin J
• Application Number:
  US16/015,003
• Publication Number:
  US 20180296336A1
• Time in Patent Office: 733 Days
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• 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 2002/9534 for repositioning of stents
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0065 toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2230/0078 hyperboloidal

Abstract

Embodiments of a prosthetic heart valve comprise an annular main body, an atrial cap extending radially outwardly from the atrial end of the main body, and a plurality of ventricular anchors extending outwardly from the ventricular end of the main body. Each ventricular anchor can have a proximal end portion connected to the ventricular end, an intermediate portion extending away from the atrial end and then back toward the atrial so as to define a first bend, and a free distal end portion that extends from the intermediate portion. The distal end portion can comprise a first section, a second section, and a second bend between the first and second sections, the first section extending from the intermediate portion in a direction toward the atrial end and radially away from the main body.

Claims

1. A prosthetic valve for implanting at a native mitral or tricuspid valve region of the heart, the native valve region having a native valve annulus and native leaflets, the prosthetic valve comprising:

a radially compressible and expandable frame comprising a double-body structure including an annular inner frame portion and an annular outer frame portion overlapping the inner frame portion, the inner and outer frame portions being connected to each other with sutures, and the outer frame portion being more flexible than the inner frame portion;

an outer fabric skirt extending around an outer surface of the outer frame;

a plurality of prosthetic leaflets supported within the inner frame portion for regulating the flow of blood in one direction through the frame; and

a plurality of ventricular anchors located outside of the outer skirt and extending from the inner frame portion, the ventricular anchors having a length to extend behind and engage native valve leaflets in a ventricle of the heart downstream of the native valve annulus.

2. The prosthetic valve of claim 1, wherein the frame comprises an atrial portion extending radially outwardly from one of the inner and outer frame portions and configured to be deployed in an atrium of the heart upstream of the native valve annulus.

3. The prosthetic valve of claim 2, wherein the atrial portion comprises an atrial sealing cap, which after being deployed, blocks the flow of blood between the native leaflets and the outside of the frame.

4. The prosthetic valve of claim 1, wherein the ventricular anchors each comprise a distal head portion comprising a pair of open areas to engage tissue in the ventricle of the heart downstream of the native valve annulus.

5. The prosthetic valve of claim 1, wherein the ventricular anchors extend along the outer surface of the outer skirt.

6. The prosthetic valve of claim 1, wherein the ventricular anchors each comprises a proximal portion connected to and extending from the inner frame portion and a distal portion that is wider in a circumferential direction than the proximal portion.

7. A prosthetic valve for implanting at a native mitral or tricuspid valve region of the heart, the native valve region having a native valve annulus and native leaflets, the prosthetic valve comprising:

a radially compressible and expandable frame comprising a double-body structure including an annular inner frame portion and an annular outer frame portion overlapping the inner frame portion;

a plurality of prosthetic leaflets supported within the inner frame portion for regulating the flow of blood in one direction through the frame; and

a plurality of ventricular anchors each comprising a proximal end portion, a distal end portion, and a curved intermediate portion located between the proximal end portion and the distal end portion, the proximal end portion being connected to an outlet end of the inner frame portion, wherein the curved intermediate portion extends radially outwardly and in a downstream direction from the outlet end of the inner frame portion and then curves in an upstream direction toward the distal end portion, the distal end portion extending from the intermediate portion and having a length to extend behind and engage native leaflets in a ventricle of the heart.

8. The prosthetic valve of claim 7, wherein the ventricular anchors are connected to the annular inner frame portion independently of each other without frame segments interconnecting adjacent ventricular anchors.

9. The prosthetic valve of claim 7, wherein the frame further comprises an atrial portion extending radially outwardly from the annular outer frame portion.

10. The prosthetic valve of claim 7, wherein an inner surface of the annular outer frame portion is secured against an outer surface of the annular inner frame portion.

11. The prosthetic valve of claim 10, wherein the annular inner frame portion and the annular outer frame portion are connected to each other with sutures.

12. The prosthetic valve of claim 7, wherein the ventricular anchors are curved in a direction extending toward an inlet end of the frame.

13. The prosthetic valve of claim 12, wherein the ventricular anchors extend alongside an outer surface of the annular outer frame portion.

14. The prosthetic valve of claim 7, further comprising an outer skirt extending around the outer surface of the annular outer frame, wherein the distal end portions of the ventricular anchors extend outside of the outer skirt.

15. The prosthetic valve of claim 7, wherein the distal end portion of the ventricular anchors comprises a head portion, the head portion having a pair of open areas.

16. The prosthetic valve of claim 7, wherein the distal end portions of the ventricular anchors are wider in a circumferential direction than the proximal end portions and the intermediate portions.