Prosthetic mitral valve

• US 10,441,421 B2
• Filed: 10/27/2017
• Issued: 10/15/2019
• Est. Priority Date: 10/28/2016
• Status: Active Grant

• Current Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Inventors: Perszyk, Brian Joseph, Glimsdale, Mathias Charles, Vietmeier, Kristopher Henry, Dale, Theodore Paul
• Primary Examiner(s): Prebilic, Paul B
• Application Number:
  US15/796,184
• Publication Number:
  US 20180116798A1
• Time in Patent Office: 718 Days
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• 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 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2454 Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• CPC Class Codes: A61F 2002/068 Modifying the blood flow model, e.g. by diffuser or deflector
• CPC Class Codes: A61F 2002/8483 Barbs
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• 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 2230/0006 circular
• CPC Class Codes: A61F 2230/0008 elliptical or oval
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0026 trapezoidal
• CPC Class Codes: A61F 2230/0052 T-shaped
• CPC Class Codes: A61F 2250/0037 differing in height or in length
• CPC Class Codes: A61F 2250/0039 : differing in diameter
• CPC Class Codes: A61F 2250/006 : modular
• CPC Class Codes: A61F 2250/0069 : Sealing means

Abstract

A prosthetic heart valve having an inflow end and an outflow end includes a stent having a collapsed condition, an expanded condition, and cells arranged in circumferential rows. The stent has an anterior side configured to be disposed adjacent an anterior native valve leaflet and a posterior side configured to be disposed adjacent a posterior native valve leaflet. A valve assembly having a plurality of leaflets is disposed within the stent and a flange is disposed about the stent. The flange includes a flared portion adjacent the inflow end and a body portion extending from the flared portion to the outflow end, the flange extending between a first set of attachment points adjacent the inflow end, and a second set of attachment points adjacent the outflow end.

Claims

1. A prosthetic heart valve having an inflow end and an outflow end, comprising:

a stent having a collapsed condition, an expanded condition, and a plurality of cells arranged in circumferential rows, the stent having an anterior side configured and arranged to be disposed adjacent an anterior native valve leaflet, and a posterior side configured and arranged to be disposed adjacent a posterior native valve leaflet;

a valve assembly disposed within the stent and having a plurality of leaflets; and

a flange disposed about the stent, the flange having a flared portion adjacent the inflow end of the prosthetic heart valve and a body portion extending from the flared portion toward the outflow end,

wherein the body portion extends a first distance toward the outflow end on one side of prosthetic heart valve and extends a second distance toward the outflow end on another side of the prosthetic heart valve, the second distance being less than the first distance.

2. The prosthetic heart valve of claim 1, wherein the flange is formed of a braided mesh.

3. The prosthetic heart valve of claim 1, wherein the body portion extends over the stent to define a first exposed portion of the stent on the anterior side of the stent, and a second exposed portion of the stent on the posterior side of the stent, the first exposed portion being larger than the second exposed portion.

4. The prosthetic heart valve of claim 3, wherein the first exposed portion is configured and arranged to allow unimpeded blood flow through the left ventricular outflow tract.

5. The prosthetic heart valve of claim 1, wherein the body portion covers about half of the stent on the anterior side of the stent.

6. The prosthetic heart valve of claim 5, wherein the flared portion is symmetric about a longitudinal axis of the stent.

7. The prosthetic heart valve of claim 1, further comprising a covering layer disposed over at least a portion of the flange.

8. The prosthetic heart valve of claim 1, further comprising at least one anchoring arm disposed adjacent the anterior side of the stent.

9. The prosthetic heart valve of claim 1, further comprising a plurality of stabilizing wires disposed adjacent the posterior side of the stent.

10. The prosthetic heart valve of claim 1, wherein the flared portion of the flange has a first diameter in an expanded condition of the flange and the body portion of the flange has a second diameter in the expanded condition of the flange, the second diameter being smaller than the first diameter.

11. The prosthetic heart valve of claim 1, wherein both the flared portion and the body portion of the flange have circular lateral cross-sections in an expanded condition of the flange.

12. The prosthetic heart valve of claim 1, wherein the flared portion has a circular lateral cross-section in an expanded condition of the flange, and the body portion of the flange has an oval lateral cross-section in the expanded condition of the flange.

13. A prosthetic heart valve having an inflow end and an outflow end, comprising:

a stent having a collapsed condition, an expanded condition, and a plurality of cells arranged in circumferential rows, the stent having an anterior side configured and arranged to be disposed adjacent an anterior native valve leaflet, and a posterior side configured and arranged to be disposed adjacent a posterior native valve leaflet;

a valve assembly disposed within the stent and having a plurality of leaflets; and

a flange disposed about the stent, the flange having a flared portion adjacent the inflow end of the prosthetic heart valve and a body portion extending from the flared portion toward the outflow end, the flange being asymmetric about a longitudinal axis such that a posterior side of the flange has a different shape than an anterior side of the flange,

wherein the flared portion has a same shape on the anterior side of the flange and on the posterior side of the flange, and the body portion has a different shape on the anterior side of the flange than on the posterior side of the flange.

14. The prosthetic heart valve of claim 13, wherein the flange is formed of a braided mesh.

15. The prosthetic heart valve of claim 13, wherein the body portion extends a first distance toward the outflow end on the anterior side of the stent, and extends a second distance toward the outflow end on the posterior side of the stent, the second distance being less than the first distance.

16. The prosthetic heart valve of claim 13, wherein the body portion extends over the stent to define a first exposed portion of the stent on the anterior side of the stent, and a second exposed portion of the stent on the posterior side of the stent, the first exposed portion being larger than the second exposed portion.

17. The prosthetic heart valve of claim 16, wherein the first exposed portion is configured and arranged to allow unimpeded blood flow through the left ventricular outflow tract.

18. The prosthetic heart valve of claim 13, further comprising at least one anchoring arm disposed adjacent the anterior side of the stent, and a plurality of stabilizing wires disposed adjacent the posterior side of the stent.

19. The prosthetic heart valve of claim 13, wherein the flange is formed of at least two portions of material that overlap one another.