Dual valve prosthesis for transcatheter valve implantation

• US 9,066,800 B2
• Filed: 03/28/2012
• Issued: 06/30/2015
• Est. Priority Date: 03/28/2012
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Clague, Cynthia, Rothstein, Paul
• Primary Examiner(s): STRANSKY, KATRINA MARIE
• Application Number:
  US13/432,664
• Publication Number:
  US 20130261738A1
• Time in Patent Office: 1,189 Days
• Field of Search: 623/2.11, 623/2.18, 623/2.12, 623/2.13, 623/2.14, 623/2.15, 623/2.16, 623/2.17, 623/1.24, 623/1.25, 623/1.26
• US Class Current: 1/1
• 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 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2220/0091 connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/006 modular

Abstract

A dual valve prosthesis having first and second prosthetic valve components with a linkage that connects the first and second prosthetic valve components together is disclosed. Each of the first and second prosthetic valve components includes a stent structure with a prosthetic valve secured therein. In a disclosed method, the first and second prosthetic valve components 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. The linkage between the first and second prosthetic valve components is configured to secure the anterior mitral valve leaflet against a wall of the left ventricle when the dual valve prosthesis is implanted within the heart.

Claims

1. A dual heart valve prosthesis comprising:

a first prosthetic heart valve component for implanting within a first native heart valve having a first stent structure with a first prosthetic heart valve secured therein, wherein when the first prosthetic heart valve component is in an expanded configuration the first stent structure has an upstream segment with a greater expanded diameter than a downstream segment thereof;

a second prosthetic heart valve component for implanting within a second native heart valve having a second stent structure with a second prosthetic heart valve secured therein, wherein when the second prosthetic heart valve component is in an expanded configuration the second stent structure has a downstream segment with a greater expanded diameter than an upstream segment; and

a linkage laterally extending between the first and second stent structures that connects the first and second prosthetic heart valve components together, wherein the linkage laterally extends between a downstream end of the first prosthetic heart valve component and an upstream end of the second prosthetic heart valve, and wherein the linkage is configured for contacting a portion of the heart disposed between the first and second native heart valves when the dual heart valve prosthesis is implanted within the heart.

2. The dual heart valve prosthesis of claim 1, wherein the linkage is comprised of one or more strands.

3. The dual heart valve prosthesis of claim 1, wherein the linkage is a hinged segment of the second stent structure that is configured to pivot outwardly from the upstream end of the second stent structure.

4. The dual heart valve prosthesis of claim 1, wherein the first and second stent structures are self-expanding.

5. The dual heart valve prosthesis of claim 1, wherein when the dual heart valve prosthesis is in a deployed configuration the linkage biases the first and second prosthetic heart valve components toward each other.

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

introducing a delivery catheter into the left ventricle of the heart, wherein a dual heart valve prosthesis having first and second prosthetic heart valve components connected by a linkage is disposed within a distal portion of the delivery catheter, wherein the linkage laterally extends between a downstream end of the first prosthetic heart valve component and an upstream end of the second prosthetic heart valve component;

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

deploying the second prosthetic heart valve component within the native aortic valve, such that the linkage connecting the first and second prosthetic heart valve components pushes the anterior leaflet of the native mitral valve against the wall of the left ventricle.

7. The method of claim 6, wherein the first prosthetic heart valve component includes a first stent structure with a prosthetic mitral valve secured therein and the second prosthetic heart valve component includes a second stent structure with a prosthetic aortic valve secured therein.

8. The method of claim 7, wherein the first and second stent structures are self-expanding and wherein the delivery catheter includes a sheath component such that during the step of introducing the delivery catheter the first and second stent structures are compressed in a delivery configuration within the distal portion of the delivery catheter by the sheath component.

9. The method of claim 8, wherein each of the steps of deploying the first and second prosthetic heart valve components within the native mitral valve and native aortic valve, respectively, includes proximally retracting the sheath component of the delivery catheter.

10. The method of claim 6, wherein the step of deploying the first prosthetic heart valve component occurs when the heart is in diastole.

11. The method of claim 6, wherein the step of introducing the delivery catheter into the left ventricle includes accessing the aorta via a transfemoral, subclavian or direct aortic approach and tracking the distal portion of the delivery catheter through the aorta and the native aortic valve into the left ventricle.

12. The method of claim 6 further comprising:

snaring a distal tip of the delivery catheter with a snare component when the distal tip of the delivery catheter is within the left ventricle;

pulling the delivery catheter with the snare component toward the left atrium; and

positioning the first prosthetic valve component disposed within the distal portion of the delivery catheter to extend through the native mitral valve.

13. The method of claim 12, wherein the step of snaring includes

creating a transeptal puncture,

introducing the snare component into the left atrium via the transeptal puncture, and

advancing the snare component through the native mitral valve into the left ventricle.

14. The method of claim 12, further comprising:

detaching the snare component from the delivery catheter distal tip; and

using the snare component to hold the first prosthetic heart valve component in place within the native mitral valve while the delivery catheter is proximally retracted.

15. The method of claim 14, wherein the steps of deploying the first and second prosthetic heart valve components within the native mitral valve and native aortic valve, respectively occur as at least a sheath component of the delivery catheter is proximally retracted.

16. A dual heart valve prosthesis comprising:

a prosthetic mitral valve component for implanting within the native mitral valve having a stent structure with a prosthetic mitral valve secured therein, wherein the stent structure of the prosthetic mitral valve component in an expanded configuration has an upstream segment with a greater expanded diameter than a downstream segment thereof;

a prosthetic aortic valve component for implanting within the native aortic valve having a stent structure with a prosthetic aortic valve secured therein, wherein the stent structure of the prosthetic aortic valve component in an expanded configuration has a downstream segment with a greater expanded diameter than an upstream segment thereof; and

a linkage that laterally extends between an outflow end of the prosthetic mitral valve component and an inflow end of the prosthetic aortic valve component to connect the respective stent structures together, wherein the linkage is configured for contacting the anterior leaflet of the native mitral valve within the left ventricle when the dual heart valve prosthesis is implanted within the heart.

17. The dual heart valve prosthesis of claim 16, wherein when the prosthetic mitral valve component is implanted within the native mitral valve in the expanded configuration the upstream segment of the stent structure is configured to contact the left atrium and the downstream segment of the stent structure is configured to extend within and contact the native mitral valve.

18. The dual heart valve prosthesis of claim 17, wherein when the prosthetic aortic valve component is implanted within the native aortic valve in the expanded configuration the downstream segment of the stent structure is configured to contact a wall of the aorta and the upstream segment of the stent structure is configured to extend within and contact the native aortic valve.