Prosthesis for transcatheter valve implantation

• US 9,295,547 B2
• Filed: 03/07/2013
• Issued: 03/29/2016
• 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, Gallagher, John
• Primary Examiner(s): ANDERSON, GREGORY A
• Application Number:
  US13/787,961
• Publication Number:
  US 20140088680A1
• Time in Patent Office: 1,118 Days
• US Class Current: 1/1
• 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 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• 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 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/008 paraboloidal

Abstract

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

Claims

1. A prosthesis comprising:

a stent structure; and

an annular frame having a circumferential border that extends in a radially outward direction from a central opening of the annular frame, wherein a width of the circumferential border taken between an inner circumference of the annular frame and an outer circumference of the annular frame is greater than an overall thickness of the annular frame taken between a first or top surface and a second or bottom surface of the circumferential border, and wherein when the prosthesis is in an expanded configuration the annular frame is laterally displaced to one side of the stent structure by a hinge segment that connects the stent structure and the annular frame.

2. The prosthesis of claim 1, wherein the stent structure further comprises a prosthetic valve.

3. The prosthesis of claim 1, wherein the annular frame further comprises a prosthetic valve.

4. The prosthesis of claim 1, wherein the first or top surface of the circumferential border defines an apposition surface.

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

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

7. The prosthesis of claim 6, wherein the hinge segment and the annular frame extend from an arched opening defined by an upstream edge of the stent structure.

8. The prosthesis of claim 7, 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.

9. The prosthesis of claim 8, 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.

10. The 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 stent structure.

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

introducing a delivery catheter transapically into the left ventricle of the heart, wherein a prosthesis disposed within a distal portion of the delivery catheter includes a stent structure, an annular frame, and a hinge segment that extends between the annular frame and the stent structure, wherein the stent structure, the annular frame and the hinge segment are self-expanding and wherein the annular frame laterally extends from the stent structure with the hinge segment therebetween when the prosthesis is implanted in the heart;

deploying the stent structure to implant within the native aortic valve; and

deploying the annular frame to implant against the native mitral valve, wherein the annular frame 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 delivery catheter includes a sheath component such that during the step of introducing the delivery catheter the stent structure, the annular frame and the hinge segment 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 the step of deploying the stent structure includes releasing the hinge segment and the 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 stent structure 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 stent structure 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 annular frame 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 occurs before releasing the annular frame.

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 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 stent structure prior to the crimping eyelets of the annular frame being released therefrom during the step of deploying the annular frame.