Prosthetic mitral valve

• US 9,962,260 B2
• Filed: 03/22/2016
• Issued: 05/08/2018
• Est. Priority Date: 03/24/2015
• 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: Krans, Mark, Dale, Theodore Paul, Para, Andrea N., Glimsdale, Mathias Charles, Benson, Thomas M., Braido, Peter N.
• Primary Examiner(s): Mathew, Seema
• Application Number:
  US15/077,070
• Publication Number:
  US 20160278923A1
• Time in Patent Office: 777 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 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2469 with resilient valve members, e.g. conical spiral
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2230/0069 cylindrical
• 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 a plurality of cells arranged in circumferential rows. The stent may include one or more securement features. One securement feature may be an anchor arm having a body portion and a free end extending from the body portion, the body portion being coupled to a perimeter of one of the plurality of cells, with the free end extending toward the inflow end in an expanded condition of the anchor arm. Another securement feature may include a flange formed of a braided mesh and having a body portion coupled to the stent and a flared portion adjacent the inflow end of the prosthetic heart valve. A valve assembly is disposed within the stent and has a plurality of leaflets.

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;

an anchor arm having a body portion and a free end extending from the body portion, the body portion of the anchor arm being coupled to a perimeter of one of the plurality of cells, and the free end extending toward the inflow end at a spaced distance radially outward from the body portion in an expanded condition of the anchor arm;

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

a flange formed of a braided mesh and having a body portion coupled to the stent and a flared portion adjacent the inflow end of the prosthetic heart valve, the body portion of the flange being positioned closer to the outflow end of the stent than is a terminal edge of the flared portion in the expanded condition of the stent,

wherein the one cell has a shape in the expanded condition of the stent and the body portion of the anchor arm has a shape in the expanded condition of the anchor arm that is substantially the same as the cell shape.

2. The prosthetic heart valve of claim 1, wherein the anchor arm comprises a wire, the body portion of the anchor arm being formed by a center portion of the wire and the free end comprising two end portions of the wire on opposite sides of the center portion.

3. The prosthetic heart valve of claim 2, wherein the anchor arm includes an atraumatic end cap coupled to the two end portions of the wire.

4. The prosthetic heart valve of claim 1, wherein the anchor arm is sutured to the one cell.

5. The prosthetic heart valve of claim 1, wherein the one cell is substantially diamond-shaped in the expanded condition of the stent and the body portion of the anchor arm is substantially diamond-shaped in the expanded condition of the anchor arm.

6. 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 smaller than the first diameter, a diameter of the flange continuously increasing from the second diameter to the first diameter in a longitudinal direction from the outflow end of the prosthetic heart valve toward the inflow end of the prosthetic heart valve.

7. The prosthetic heart valve of claim 1, wherein the flange includes a first braided mesh layer, a second braided mesh layer, and a layer of fabric between the first layer and the second layer.

8. The prosthetic heart valve of claim 1, wherein the flared portion of the flange terminates at an inflow end of the flange and the body portion of the flange terminates at an outflow end of the flange, the outflow end of the flange being positioned between the free end portion of the anchor arm and the body portion of the anchor arm in the expanded condition of the stent.

9. The prosthetic heart valve of claim 1, wherein the plurality of cells include an odd number of cells arranged in a first circumferential row, four anchor arms being positioned in the first circumferential row so that a first pair of the anchor arms is symmetrical to a second pair of the anchor arms relative to a plane bisecting the prosthetic heart valve.

10. The prosthetic heart valve of claim 1, wherein the plurality of cells include an even number of cells arranged in a first circumferential row, four anchor arms being positioned in the first circumferential row so that a first pair of the anchor arms is symmetrical to a second pair of the anchor arms relative to a first plane bisecting the prosthetic heart valve, and a third pair of the anchor arms is symmetrical to a fourth pair of the anchor arms relative to a second plane orthogonal to the first plane.

11. 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;

an anchor arm having a body portion and a free end extending from the body portion, the body portion of the anchor arm being coupled to a perimeter of one of the plurality of cells, and the free end extending toward the inflow end at a spaced distance radially outward from the body portion in an expanded condition of the anchor arm;

a valve assembly disposed within the stent and having a plurality of leaflets, and a flange formed of a braided mesh and having a body portion coupled to the stent and a flared portion adjacent the inflow end of the prosthetic heart valve, wherein the flange includes a first braided mesh layer, a second braided mesh layer, and a layer of fabric between the first layer and the second layer

wherein the plurality of cells includes an even number of cells arranged in a first circumferential row, four anchor arms being positioned in the first circumferential row so that a first pair of the anchor arms is symmetrical to a second pair of the anchor arms relative to a first plane bisecting the prosthetic heart valve, and a third pair of the anchor arms is symmetrical to a fourth pair of the anchor arms relative to a second plane orthogonal to the first plane.

12. The prosthetic heart valve of claim 11, wherein at least one of the anchor arms comprises a wire, the body portion of the anchor arm being formed by a center portion of the wire and the free end comprising two end portions of the wire on opposite sides of the center portion.

13. The prosthetic heart valve of claim 12, wherein at least one of the anchor arms includes an atraumatic end cap coupled to the two end portions of the wire.

14. The prosthetic heart valve of claim 11, wherein at least one of the anchor arms is sutured to the one cell.

15. The prosthetic heart valve of claim 11, wherein the one cell has a shape in the expanded condition of the stent and the body portion of at least one of the anchor arms has a shape in the expanded condition of the anchor arm that is substantially the same as the cell shape.

16. The prosthetic heart valve of claim 15, wherein the one cell is substantially diamond-shaped in the expanded condition of the stent and the body portion of the at least one of the anchor arms is substantially diamond-shaped in the expanded condition of the anchor arm.

17. The prosthetic heart valve of claim 11, 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 smaller than the first diameter.

18. The prosthetic heart valve of claim 11, wherein the flared portion of the flange terminates at an inflow end of the flange and the body portion of the flange terminates at an outflow end of the flange, the outflow end of the flange being positioned between the free end portion of at least one of the anchor arm and the body portion of the at least one anchor arm in the expanded condition of the stent.