Transcatheter valve replacement

• US 9,526,612 B2
• Filed: 07/27/2015
• Issued: 12/27/2016
• Est. Priority Date: 03/11/2013
• 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: Board, Stephanie Marie, Chalekian, Aaron J., Russo, Patrick P., Oslund, John
• Primary Examiner(s): Manahan, Todd E
• Assistant Examiner(s): HERBERMANN, ERICH G.
• Application Number:
  US14/809,558
• Publication Number:
  US 20150327999A1
• Time in Patent Office: 519 Days
• Field of Search: 623/2.11, 623 215- 218, 623/2.38, 623/2.28, 623/23.65, 623 124- 126
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2403 with pivoting rigid closure members check valves with hinged closure members in general F16K15/03
• 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 2230/0006 circular
• CPC Class Codes: A61F 2230/0069 cylindrical
• 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 collapsible and expandable stent, a collapsible and expandable valve assembly disposed within the stent and having a plurality of leaflets, and a deformable frame having a first end and a second end. The frame includes braided wires forming a body having a lumen extending therethrough for receiving the stent and the valve assembly, the body having a plurality of diameters from the first end to the second end.

Claims

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

a collapsible and expandable stent having a plurality of struts;

a collapsible and expandable valve assembly disposed within the stent and having a plurality of leaflets configured to permit a blood flow in a first direction from the inflow end to the outflow end, and to impede the blood flow in a second opposite direction; and

a deformable frame having a first end and a second end, the frame including a plurality of shape-memory metallic wires that are braided together to form a three-dimensional body defining an inner surface in contact with struts of the stent, an outer surface for contacting native tissue, the body having a thickness between the inner surface and the outer surface, the thickness being variable from a first distance in an uncompressed state, and a second distance when a force is applied to the body, the second distance being less than the first distance, the body having a lumen extending therethrough for receiving the stent and the valve assembly.

2. The prosthetic heart valve of claim 1, wherein the frame further comprises at least one hook configured to engage heart tissue.

3. The prosthetic heart valve of claim 1, wherein the body includes a first diameter and at least one flange having a second diameter that is larger than the first diameter for anchoring the body within a native valve annulus.

4. The prosthetic heart valve of claim 3, wherein the at least one flange is disposed adjacent the outflow end of the prosthetic heart valve.

5. The prosthetic heart valve of claim 3, wherein the at least one flange includes a first section that extends away from the body and a second section that extends back toward the body.

6. The prosthetic heart valve of claim 3, further comprising a stabilizing wire disposed on the at least one flange and configured to engage heart tissue.

7. The prosthetic heart valve of claim 3, further comprising a dumbbell-shaped anchor for coupling the at least one flange to heart tissue.

8. The prosthetic heart valve of claim 1, wherein the frame includes a scalloped portion adjacent the outflow end of the prosthetic heart valve.

9. The prosthetic heart valve of claim 1, wherein the frame extends in a longitudinal direction between the inflow end and the outflow end of the prosthetic heart valve, the body portion of the frame including a dilated portion having a longitudinal cross-section that is substantially circular.

10. The prosthetic heart valve of claim 9, wherein the prosthetic heart valve is configured to replace a native mitral valve.

11. The prosthetic heart valve of claim 9, wherein the valve assembly includes two leaflets.

12. The prosthetic heart valve of claim 1, further comprising a reinforcement coupled to the frame to promote tissue growth.

13. The prosthetic heart valve of claim 12, wherein the reinforcement includes polyester strands.

14. The prosthetic heart valve of claim 12, wherein the frame has a non-circular transverse cross-section.

15. A method of deploying a prosthetic heart valve at a target site, the prosthetic heart valve including a stent having a plurality of struts, a valve assembly disposed within the stent and configured to permit a blood flow in a first direction from the inflow end to the outflow end, and to impede the blood flow in a second opposite direction, and a deformable frame having a first end and a second end, the frame including a plurality of shape-memory metallic wires that are braided together to form a three-dimensional body defining an inner surface in contact with struts of the stent, an outer surface for contacting native tissue, the body having a thickness between the inner surface and the outer surface, the thickness being variable from a first distance in an uncompressed state, and a second distance when a force is applied to the body, the second radial distance being less than the first radial distance, the body having a lumen extending therethrough for receiving the stent and the valve assembly, the method comprising:

deploying the deformable frame at the target site and allowing the frame to expand to fill irregularities in the native valve annulus; and

deploying the stent and valve via a delivery device within the expanded frame.

16. The method of claim 15, wherein the target site is the mitral valve annulus of a patient.

17. The method of claim 15, wherein the delivery device comprises a catheter and an inner shaft, the inner shaft being configured to mate with the stent.

18. The method of claim 15, further comprising recapturing the stent within the catheter after expansion at the target site.