Prosthetic valve for replacing mitral valve

• US 10,463,481 B2
• Filed: 09/08/2016
• Issued: 11/05/2019
• Est. Priority Date: 02/04/2013
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Geist, Stephen C., Taft, Robert C., Oba, Travis Zenyo, Sok, Sam, Peterson, Matthew A., Golemo, Kevin M., Chau, Mark, Yi, Seung-Beom
• Primary Examiner(s): Prone, Christopher D.
• Assistant Examiner(s): Shipmon, Tiffany P
• Application Number:
  US15/259,988
• Publication Number:
  US 20170231759A1
• Time in Patent Office: 1,153 Days
• CPC Class Codes: A61B 6/4441 the rigid structure being a C-arm or U-arm
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• 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 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• 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 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0029 differing in bending or flexure capacity
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

A prosthetic heart valve includes a collapsible and expandable frame having a main body, an atrial portion, and at least one ventricular anchor. The atrial portion extends radially outwardly relative to the main body and the ventricular anchor extends from a ventricular end of the main body. The main body and the atrial portion are preferably separate metal components that are coupled together via sutures or a fabric member. The prosthetic heart valve also includes a valve structure that is supported in the main body of the frame. The valve structure has a plurality of leaflets for regulating the flow of blood in one direction.

Claims

1. A prosthetic heart valve comprising:

a radially collapsible and radially expandable frame having a main body, an atrial portion, and at least one ventricular anchor, wherein the main body has an atrial end and a ventricular end, the atrial portion extending radially outwardly relative to the main body and comprising a continuous wire form that extends around the main body, the ventricular anchor extending from the ventricular end of the main body;

wherein the main body and the atrial portion are separate metal components that are coupled to each other via sutures or a fabric member; and

a valve structure having a plurality of leaflets and configured for regulating the flow of blood in one direction through the prosthetic heart valve, wherein the valve structure is supported in the main body of the frame.

2. The prosthetic heart valve of claim 1, wherein the main body and the atrial portion are coupled together by the fabric member.

3. The prosthetic heart valve of claim 2, wherein the fabric member comprises a sealing member that is configured to seal against native tissue surrounding the prosthetic valve upon implantation of the prosthetic valve within a native heart valve of a patient.

4. The prosthetic heart valve of claim 1, wherein the main body and the atrial portion are coupled together by sutures.

5. The prosthetic heart valve of claim 1, wherein the atrial portion is spaced radially outwardly from the main body.

6. The prosthetic heart valve of claim 1, wherein the atrial portion has an axial stiffness, the main body has an axial stiffness, and the axial stiffness of the atrial portion is less than the axial stiffness of the main body.

7. The prosthetic heart valve of claim 1, wherein the atrial portion has a radial stiffness, the main body has a radial stiffness, and the radial stiffness of the atrial portion is less than the radial stiffness of the main body.

8. The prosthetic heart valve of claim 1, wherein the atrial portion is axially spaced from the atrial end of the main body toward the ventricular end of the main body.

9. The prosthetic heart valve of claim 1, wherein the atrial portion comprises a plurality of projections distributed circumferentially around the main body.

10. The prosthetic heart valve of claim 1, wherein the main body has a plurality of interconnected struts that form vertices at connection points, and the projections of the atrial portion extend from respective vertices of the main body.

11. The prosthetic heart valve of claim 1, wherein the wire form comprises a plurality of loops distributed circumferentially around the main body.

12. A prosthetic heart valve comprising:

a collapsible and expandable frame having a first portion and a second portion, wherein the first portion has at least one ventricular anchor and is at least partially disposed radially inwardly relative to the second portion, and the second portion comprises an atrial portion extending radially outwardly away from the first portion;

wherein the first portion and the second portion are separate metal components;

a fabric member covering at least a portion of the second portion of the frame, wherein the first and the second portions of the frame are connected together by the fabric member; and

a valve structure having a plurality of leaflets and configured for regulating the flow of blood in one direction through the prosthetic heart valve, wherein the valve structure is coupled to the frame.

13. The prosthetic heart valve of claim 12, wherein the first portion comprises an inflow end and an outflow end, and the second portion is axially spaced from the inflow end of the first portion toward the outflow end of the first portion.

14. The prosthetic heart valve of claim 12, wherein the first portion comprises has a radial stiffness that is greater than a radial stiffness of the atrial portion.

15. The prosthetic heart valve of claim 12, wherein the first portion comprises has an axial stiffness that is greater than an axial stiffness of the atrial portion.

16. The prosthetic heart valve of claim 12, wherein the first portion is an annular main body portion and the valve structure is supported in the main body portion.

17. The prosthetic heart valve of claim 12, wherein the fabric member blocks blood from flowing through openings in the second portion.

18. A prosthetic heart valve comprising:

a collapsible and expandable frame having an annular first portion and a separate, annular second portion, wherein the first portion has at least one ventricular anchor and is at least partially disposed radially inwardly relative to the second portion, and the second portion comprises an atrial portion extending radially outwardly away from the first portion, and wherein the second portion is not directly attached to the first portion;

a fabric member covering at least a portion of the second portion of the frame, wherein the first and the second portions of the frame are coupled to the fabric member; and

a valve structure having a plurality of leaflets and configured for regulating the flow of blood in one direction through the prosthetic heart valve, wherein the valve structure is supported in the first portion.

19. The prosthetic heart valve of claim 18, wherein the second portion is more flexible than the first portion.

20. The prosthetic heart valve of claim 18, wherein the frame comprises a gap extending radially between the first and second portions and extending annularly around an inflow end portion of the first portion, and wherein the fabric member extends radially over the gap and to the first and second portions.