Replacement mitral valve

• US 10,179,044 B2
• Filed: 03/17/2017
• Issued: 01/15/2019
• Est. Priority Date: 05/19/2014
• Status: Active Grant

• Current Assignee: Edwards Lifesciences CardiAQ LLC (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences CardiAQ LLC (Edwards Lifesciences Corporation)
• Inventors: Ratz, J. Brent, Pesce, Luca, Rabito, Glen T., Nguyen, Christine Thanh
• Primary Examiner(s): SCHILLINGER, ANN M
• Application Number:
  US15/462,438
• Publication Number:
  US 20170189179A1
• Time in Patent Office: 669 Days
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/005 using adhesives
• 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 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

A prosthesis can be configured to grasp intralumenal tissue when deployed within a body cavity and prevent axial flow of fluid around an exterior of the prosthesis. The prosthesis can include an expandable frame configured to radially expand and contract for deployment within the body cavity, and an annular flap positioned around an exterior of the expandable frame. In some embodiments, the annular flap can extend outward from the frame and have a collapsed configuration and an expanded configuration.

Claims

1. A prosthesis for placement within a native mitral valve having a native mitral valve annulus, the prosthesis comprising:

an expandable frame comprising a proximal end, a distal end, a middle region extending between the proximal and distal ends, and a longitudinal axis extending therethrough, the expandable frame configured to radially expand and contract for deployment within the native mitral valve, the middle region having a larger cross-sectional dimension than the proximal and distal ends when the expandable frame is in an expanded configuration;

a distal anchoring portion comprising a first set of distal anchors and a second set of distal anchors, at least a portion of each distal anchor of the first set and the second set extending generally proximally when the expandable frame is in an expanded configuration, each distal anchor of the first set comprising a first individual cushion and each distal anchor of the second set comprising a second individual cushion smaller than the first individual cushion such that each distal anchor of the first set is larger than each distal anchor of the second set, the first and second individual cushions being made from a fabric material and being adapted for reducing trauma to surrounding tissue and extending at least a majority of a length of each distal anchor; and

a valve body positioned within an interior of the expandable frame, wherein the valve body comprises a plurality of leaflets configured to allow flow in a first direction and prevent flow in a second opposite direction.

2. The prosthesis of claim 1, wherein, in an expanded configuration, each distal anchor of the first set extends further proximally than each distal anchor of the second set.

3. The prosthesis of claim 1, wherein at least some of the first and second individual cushions comprise an inner portion and a covering.

4. The prosthesis of claim 3, wherein the inner portion is formed of a foam material.

5. The prosthesis of claim 3, wherein the covering is formed of a fabric material.

6. The prosthesis of claim 3, wherein the covering extends the entire length of the distal anchor to which the first or second individual cushion is attached.

7. The prosthesis of claim 3, wherein the covering extends partially along the length of the distal anchor to which the first or second individual cushion is attached.

8. The prosthesis of claim 1, wherein each distal anchor of the second set is exposed, each distal anchor of the second set being positioned circumferentially between distal anchors of the first set.

9. The prosthesis of claim 1, wherein each distal anchor of the second set is positioned circumferentially between distal anchors of the first set.

10. The prosthesis of claim 1, wherein a ratio of distal anchors of the first set to distal anchors of the second set is 1:

1.

11. The prosthesis of claim 1, wherein a ratio of distal anchors of the first set to distal anchors of the second set is 2:

1.

12. The prosthesis of claim 1, wherein each distal anchor of the second set is positioned circumferentially between distal anchors of the first set.

13. The prosthesis of claim 1, wherein a ratio of distal anchors of the first set to distal anchors of the second set is 1:

1.

14. The prosthesis of claim 1, wherein a ratio of distal anchors of the first set to distal anchors of the second set is 2:

1.

15. The prosthesis of claim 1, wherein the first and second individual cushions are formed of a material which encourages tissue growth.

16. The prosthesis of claim 1, further comprising a plurality of proximal anchors, at least a portion of each proximal anchor extending generally distally when the expandable frame is in an expanded configuration.

17. The prosthesis of claim 1, wherein each distal anchor of the first set and second set are circumferentially spaced apart from each other.

18. The prosthesis of claim 1, wherein the first set of distal anchors and the second set of distal anchors are configured to extend between chordae tendineae and behind leaflets of the native mitral valve.