Dual Valve Prosthesis for Transcatheter Valve Implantation

• US 20130261737A1
• Filed: 03/28/2012
• Published: 10/03/2013
• Est. Priority Date: 03/28/2012
• Status: Active Grant

• Current Assignee: Medtronic Vascular Galway Limited (Medtronic Plc)
• Original Assignee: Medtronic Vascular Galway Limited (Medtronic Plc)
• Inventors: Costello, Declan
• Granted Patent: US 8,926,694 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2230/0054 V-shaped

Abstract

A dual valve prosthesis having first and second prosthetic valve sections is disclosed. The first prosthetic valve section includes a stent structure with a first prosthetic valve secured therein and the second prosthetic valve section includes an annular frame with a second prosthetic valve secured therein. When the dual valve prosthesis is in an expanded configuration, the annular frame extends from the stent structure such that the first and second prosthetic valves are laterally offset from each other. In a method in accordance herewith, the first and second prosthetic valve sections include prosthetic aortic and mitral valves, respectively, and the dual heart valve prosthesis is configured to replace both the native aortic and mitral valves of the heart in a single transcatheter heart valve implantation procedure.

Claims

1. A dual valve prosthesis comprising:

a first prosthetic valve section having a stent structure with a first prosthetic valve secured therein; and

a second prosthetic valve section having an annular frame with a second prosthetic valve secured therein, wherein when the dual valve prosthesis is in an expanded configuration the annular frame laterally extends from the stent structure such that the first and second prosthetic valves are laterally offset from each other.

2. The dual valve prosthesis of claim 1, wherein the annular frame forms a border that radially extends around the second prosthetic valve to define an apposition surface.

3. The dual valve prosthesis of claim 1, wherein the annular frame has a profile of a flat washer.

4. The dual valve prosthesis of claim 1, wherein a hinge segment laterally extends between the annular frame and the stent structure when the dual valve prosthesis is in the expanded configuration.

5. The dual valve prosthesis of claim 4, wherein the hinge segment and the annular frame extend from an arched opening defined by an upstream edge of the stent structure.

6. The dual valve prosthesis of claim 5, wherein at least an upstream portion of the stent structure, annular frame and hinge segment are an integral self-expanding structure with a shape set to return to the expanded configuration from a compressed delivery configuration.

7. The dual valve prosthesis of claim 6, wherein a downstream portion of the stent structure includes a plurality of engagement arms each having an upstream end that is radially spaced from the upstream portion of the stent structure.

8. The dual valve prosthesis of claim 1, wherein the first prosthetic valve is a trileaflet prosthetic aortic valve.

9. The dual valve prosthesis of claim 8, wherein the second prosthetic valve is a bicuspid prosthetic mitral valve.

10. The dual valve prosthesis of claim 1, wherein in the expanded configuration the annular frame laterally extends from the stent structure at an angle in the range of 45 to 135 degrees with respect to a longitudinal axis of the first prosthetic valve section.

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 includes a first prosthetic heart valve section having a stent structure with a first prosthetic valve secured therein and a second prosthetic heart valve section having an annular frame with a second prosthetic valve secured therein, wherein the annular frame laterally extends from the stent structure when the dual valve prosthesis is implanted in the heart;

deploying the first prosthetic heart valve section to implant within the native aortic valve such that the first prosthetic valve is a replacement aortic valve; and

deploying the second prosthetic heart valve section to implant against the native mitral valve such that the second prosthetic valve is a replacement mitral valve, wherein the annular frame of the second prosthetic heart valve section exerts an apposition force that acts against the heart structure that surrounds the native mitral valve when deployed.

12. The method of claim 11, wherein the stent structure and the annular frame are self-expanding and wherein the delivery catheter includes a sheath component such that during the step of introducing the delivery catheter the stent structure and annular frame are compressed in a delivery configuration within the distal portion of the delivery catheter by the sheath component.

13. The method of claim 12, wherein a hinge segment extends between the annular frame and the stent structure and wherein the step of deploying the second prosthetic heart valve section includes releasing the hinge segment and annular frame from the sheath component to permit the annular frame to rotate outwardly from the stent structure at the hinge segment.

14. The method of claim 12, wherein the step of deploying the first prosthetic heart valve section includes positioning the stent structure thereof within the native aortic valve and releasing engagement arms of the stent structure from the sheath component such that the engagement arms implant within the aortic sinuses.

15. The method of claim 14, wherein the step of deploying the first prosthetic heart valve section includes releasing an upstream portion of the stent structure from the sheath component to implant the upstream portion within the annulus of the native aortic valve.

16. The method of claim 15, wherein the step of deploying the second prosthetic heart valve section includes releasing the annular frame from the sheath component into apposition with a surface of the left ventricle that surrounds the native mitral valve.

17. The method of claim 16, wherein releasing the engagement arms and upstream portion of the stent structure of the first prosthetic heart valve section occurs before releasing the annular frame of the second prosthetic heart valve section.

18. The method of claim 11, wherein the delivery catheter includes a rebated retainer within a sheath component thereof that is used to secure crimping eyelets of the stent structure and the annular frame when the dual valve prosthesis is in a compressed delivery configuration within the sheath component.

19. The method of claim 18, wherein the crimping eyelets of the stent structure and the annular frame are held within corresponding recesses of the rebated retainer by the sheath component.

20. The method of claim 19, wherein the crimping eyelets of the stent structure are released from the rebated retainer and sheath component during the step of deploying the first prosthetic heart valve section prior to the crimping eyelets of the annular frame being released therefrom during the step of deploying the second prosthetic heart valve section.