Dual valve prosthesis for transcatheter valve implantation

• US 9,023,098 B2
• Filed: 03/28/2012
• Issued: 05/05/2015
• Est. Priority Date: 03/28/2012
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Kuehn, Stephen
• Primary Examiner(s): Nguyen, Tuan V
• Assistant Examiner(s): NGUYEN, TIN DUC
• Application Number:
  US13/432,950
• Publication Number:
  US 20130261739A1
• Time in Patent Office: 1,133 Days
• Field of Search: 623/1.11, 623/2.18, 623/2.11
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• 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 2230/001 Figure-8-shaped, e.g. hourglass-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/006 modular

Abstract

A dual valve prosthesis having a self-expanding anchoring frame with first and second prosthetic valve assemblies attached to the anchoring frame is disclosed. Each of the first and second prosthetic valve assemblies includes a balloon-expandable stent structure with a prosthetic valve secured therein. In a disclosed method, the first and second prosthetic valve assemblies include prosthetic mitral and aortic valves, respectively, and the dual heart valve prosthesis is configured to replace both the native mitral and aortic valves of the heart in a single transcatheter heart valve implantation procedure.

Claims

1. A dual valve prosthesis for concurrent deployment within first and second adjacent native valves comprising:

an anchoring frame having an expandable framework;

a first prosthetic valve assembly configured for deployment within the first native valve, the first prosthetic valve assembly being attached to the anchoring frame; and

a second prosthetic valve assembly configured for concurrent deployment within the adjacent second native valve, the second prosthetic valve assembly being attached to the anchoring frame to be laterally separated from the first prosthetic valve assembly by a portion of the anchoring frame, wherein the portion of the anchoring frame is configured to extend between the first and second adjacent native valves when the dual valve prosthesis is deployed, and

wherein each of the first and second prosthetic valve assemblies includes a balloon-expandable stent structure with a prosthetic valve secured therein.

2. The dual valve prosthesis of claim 1, wherein the expandable framework of the anchoring frame is self-expanding.

3. The dual valve prosthesis of claim 2, wherein the expandable framework of the anchoring frame is formed from a mesh made of nitinol wire.

4. The dual valve prosthesis of claim 2, wherein each of the stent structures of the first and second prosthetic valve assemblies is attached to the anchoring frame by sutures.

5. The dual valve prosthesis of claim 1, wherein the anchoring frame includes first and second ports, wherein the first prosthetic valve assembly is attached to the anchoring frame such that the balloon-expandable stent structure of the first prosthetic valve assembly is substantially surrounded by the anchoring frame with an inflow end of the first prosthetic valve assembly being positioned proximate the first port.

6. The dual valve prosthesis of claim 5, wherein an inflow end of the second prosthetic valve assembly is attached to the second port such that the balloon-expandable stent structure of the second prosthetic valve assembly extends from the anchoring frame.

7. The dual valve prosthesis of claim 6, wherein the anchoring frame includes a skirt portion that flares outwardly when the anchoring frame is in an expanded configuration.

8. The dual valve prosthesis of claim 1, wherein the anchoring frame is at least partially covered by a graft material.

9. The dual valve prosthesis of claim 1, wherein the prosthetic valve of the first prosthetic valve assembly is a prosthetic mitral valve.

10. The dual valve prosthesis of claim 9, wherein the prosthetic valve of the second prosthetic valve assembly is a prosthetic aortic valve.

11. A dual valve prosthesis for concurrent deployment within a mitral valve and an aortic valve comprising:

an anchoring frame;

a prosthetic mitral valve assembly having a balloon-expandable stent structure attached to the anchoring frame and having a prosthetic mitral valve secured the balloon-expandable stent structure, wherein the balloon-expandable stent structure of the prosthetic mitral valve assembly extends within and is surrounded by the anchoring frame; and

a prosthetic aortic valve assembly having a balloon-expandable stent structure attached to the anchoring frame to be laterally offset from the balloon-expandable stent structure of the prosthetic mitral valve assembly and having a prosthetic aortic valve secured therein, wherein the balloon-expandable stent structure of the prosthetic aortic valve assembly is attached to the anchoring frame such that the balloon-expandable stent structure of the prosthetic aortic valve assembly extends away from the anchoring frame, wherein a portion of the prosthetic aortic valve assembly extends within and is surrounded by the anchoring frame.

12. The dual valve prosthesis of claim 11, wherein the anchoring frame has a self-expanding framework.

13. The dual valve prosthesis of claim 12, wherein the self-expanding framework of the anchoring frame is formed from a mesh made of nitinol wire.

14. The dual valve prosthesis of claim 11, wherein the anchoring frame includes a mitral port and an aortic port at a first end thereof with an inflow end of the balloon-expandable stent structure of the prosthetic mitral valve assembly being attached to the mitral port to extend within the anchoring frame therefrom and with an inflow end of the balloon-expandable stent structure of the prosthetic aortic valve assembly being attached to the aortic port to extend away from the anchoring frame therefrom.

15. The dual valve prosthesis of claim 14, wherein the anchoring frame includes a skirt portion at an opposing second end thereof that flares outwardly when the anchoring frame is in an expanded configuration.

16. A dual valve prosthesis for deployment within first and second adjacent native valves comprising:

an anchoring frame defining laterally separated first and second ports at a first end thereof and a skirt portion at a second end thereof, wherein the skirt portion flares outwardly when the anchoring frame is in an expanded configuration;

a first prosthetic valve assembly configured for deployment within the first native valve, the first prosthetic valve assembly having a stent structure with an inflow end attached to the anchoring frame at the first port and having a first prosthetic valve secured therein; and

a second prosthetic valve assembly configured for deployment within the adjacent second native valve, the second prosthetic valve assembly having a stent structure with an inflow end attached to the anchoring frame at the second port and having a second prosthetic valve secured therein, wherein respective stent structures of the first and second prosthetic valve assemblies are disposed on the anchoring frame to be laterally separated from each other by a portion of the anchoring frame.

17. The dual valve prosthesis of claim 16, wherein the first prosthetic valve assembly extends within the anchoring frame from the first port to be substantially surrounded by the anchoring frame.

18. The dual valve prosthesis of claim 17, wherein the second prosthetic valve assembly extends away from the anchoring frame from the second port.

19. The dual valve prosthesis of claim 16, wherein the first and second ports of the anchoring frame are longitudinally offset from each other.

20. The dual valve prosthesis of claim 16, wherein the stent structures of each of the first and second prosthetic valve assemblies is balloon-expandable with the respective first and second prosthetic valves being secured therein.