Dual Valve Prosthesis for Transcatheter Valve Implantation

• US 20130261739A1
• Filed: 03/28/2012
• Published: 10/03/2013
• Est. Priority Date: 03/28/2012
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Kuehn, Stephen
• Granted Patent: US 9,023,098 B2
• Time in Patent Office: Days
• 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 comprising:

an anchoring frame;

a first prosthetic valve assembly attached to the anchoring frame; and

a second prosthetic valve assembly attached to the anchoring frame to be positioned laterally of the first prosthetic valve assembly,

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 anchoring frame is self-expanding.

3. The dual valve prosthesis of claim 2, wherein 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 stent structure thereof is substantially surrounded by the anchoring frame with an inflow end of the first prosthetic valve 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 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 e second prosthetic valve assembly is a prosthetic aortic valve.

11. A method of implanting a dual valve prosthesis within a beating heart comprising:

introducing a delivery catheter transapically into the left ventricle of the heart, wherein a dual heart valve prosthesis disposed within a distal portion of the delivery catheter having an anchoring frame with first and second prosthetic heart valve assemblies attached thereto;

positioning the first prosthetic heart valve assembly within the native mitral valve;

positioning the second prosthetic heart valve assembly within the native aortic valve;

deploying the anchoring frame into contact with at least the area of the left ventricle that surrounds the native mitral and aortic valves;

deploying the first prosthetic heart valve assembly within the native mitral valve; and

deploying the second prosthetic heart valve assembly within the native aortic valve.

12. The method of claim 11 wherein the step of deploying the anchoring frame occurs when the heart is in diastole.

13. The method of claim 12, wherein during the step of deploying the anchoring frame a heel portion of the anchoring frame pushes the anterior leaflet of the native mitral valve against an area of the ventricle wall while a skirt portion of the anchoring frame pushes the posterior leaflet of the native mitral valve against another area of the ventricle wall.

14. The method of claim 11, wherein the delivery catheter includes a sheath component and first and second balloon catheters and wherein during the step of introducing the delivery catheter the first prosthetic heart valve assembly is mounted on a balloon of the first balloon catheter and the second prosthetic heart valve assembly is mounted on a balloon of the second balloon catheter within the distal portion of the delivery catheter.

15. The method of claim 14, wherein the anchoring frame is self-expanding and wherein during the step of introducing the delivery catheter the anchoring frame is compressed in a delivery configuration within the distal portion of the delivery catheter by the sheath component.

16. The method of claim 15, wherein the step of positioning the first prosthetic heart valve assembly includes distally advancing the first balloon catheter from the delivery catheter such that the balloon thereof is disposed within the native mitral valve, and

wherein the step of deploying the first prosthetic heart valve assembly includes inflating the balloon to expand a stent structure of the first prosthetic heart valve assembly.

17. The method of claim 16, wherein the step of deploying the first prosthetic heart valve assembly includes expanding the stent structure of the first prosthetic heart valve assembly into contact with a portion of the anchoring frame deployed against the native mitral valve.

18. The method of claim 16, wherein the step of positioning the second prosthetic heart valve assembly includes distally advancing the second balloon catheter from the delivery catheter such that the balloon thereof is disposed within the native aortic valve, and wherein the step of deploying the second prosthetic heart valve assembly includes inflating the balloon to expand a stent structure of the second prosthetic heart valve assembly.

19. The method of claim 18, wherein the step of deploying the anchoring frame and the step of deploying the second prosthetic heart valve assembly occur before the step of deploying the first prosthetic heart valve assembly within the native mitral valve.

20. The method of claim 18, wherein the step of deploying the second prosthetic heart valve assembly includes expanding the stent structure of the second prosthetic heart valve assembly into contact with the native aortic valve.