Transcatheter valve replacement

• US 9,833,313 B2
• Filed: 11/03/2016
• Issued: 12/05/2017
• Est. Priority Date: 03/11/2013
• Status: Active Grant

• Current Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories)
• Original Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories)
• Inventors: Board, Stephanie Marie, Chalekian, Aaron J., Russo, Patrick P., Oslund, John
• Primary Examiner(s): Yabut, Diane
• Assistant Examiner(s): HERBERMANN, ERICH G.
• Application Number:
  US15/342,468
• Publication Number:
  US 20170049564A1
• Time in Patent Office: 397 Days
• Field of Search: 623 124- 126, 623 211, 623 215- 218, 623 238, 623 228, 623 2365
• 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 forming a plurality of cells, an inflow end and an outflow end;

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 an inlet end and an outlet end, the frame having a body portion formed of braided wires arranged in a three-dimensional shape, the braided wires being moveable relative to one another to change the radial thickness of the body portion upon an application of an external force, the frame further comprising a lumen extending through the body portion from the inlet end to the outlet end for receiving the stent and the valve assembly, the body portion having an upper flange that extends between a first junction coupled to the stent, and a first unattached edge defining the inlet end and extending beyond the inflow end of the stent in the deployed state, wherein the upper flange has a series of gradually-decreasing diameters from the first unattached edge to the first junction in the deployed state.

2. The prosthetic heart valve of claim 1, further comprising at least one hook configured to engage heart tissue.

3. The prosthetic heart valve of claim 1, further comprising a stabilizing wire disposed on the upper flange and configured to engage heart tissue.

4. The prosthetic heart valve of claim 1, further comprising a dumbbell-shaped anchor for coupling the upper flange to heart tissue.

5. 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.

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

7. The prosthetic heart valve of claim 6, wherein the reinforcement includes polyester strands.

8. The prosthetic heart valve of claim 1, wherein the frame has a non-circular transverse cross-section.

9. The prosthetic heart valve of claim 1, wherein the prosthetic heart valve is configured to replace a native mitral valve.

10. The prosthetic heart valve of claim 1, wherein the valve assembly includes two leaflets.

11. The prosthetic heart valve of claim 1, further comprising a lower flange disposed adjacent the outlet end of the frame.

12. The prosthetic heart valve of claim 11, wherein the lower flange is scalloped.

13. The prosthetic heart valve of claim 11, wherein the lower flange and the upper flange collectively straddle a native valve annulus.

14. A method of deploying a prosthetic heart valve having an inflow end and an outflow end at a target site, the prosthetic heart valve including a collapsible and expandable stent having a plurality of struts forming a plurality of cells, an inflow end and an outflow end, 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 an inlet end and an outlet end, the frame having a body portion formed of braided wires arranged in a three-dimensional shape, the braided wires being moveable relative to one another to change the radial thickness of the body portion upon an application of an external force, the frame further comprising a lumen extending through the body portion from the inlet end to the outlet end for receiving the stent and the valve assembly, the body portion having an upper flange that extends between a first junction coupled to the stent, and a first unattached edge defining the inlet end and extending beyond the inflow end of the stent in the deployed state, wherein the upper flange has a series of gradually-decreasing diameters from the first unattached edge to the first junction in the deployed state, the method comprising:

deploying the deformable frame at the target site and allowing the radial thickness of the frame to increase to fill irregularities in the native valve annulus; and

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

15. The method of claim 14, wherein the target site is the mitral valve annulus of a patient.

16. The method of claim 14, wherein the delivery device comprises a catheter and an inner shaft, the inner shaft being configured to mate with the stent.

17. The method of claim 16, further comprising recapturing the stent within the catheter after expansion at the target site.

18. The method of claim 14, wherein deploying the deformable frame at the target site includes deploying the upper flange in the left atrium.

19. The method of claim 14, further comprising providing a reinforcement coupled to the frame to promote tissue growth.

20. The method of claim 14, further comprising providing at least one of a stabilizing wire and a hook, and anchoring the prosthetic heart valve to native heart tissue via the at least one of a stabilizing wire and a hook.