Systems and methods for heart valve therapy

• US 9,750,605 B2
• Filed: 03/27/2015
• Issued: 09/05/2017
• Est. Priority Date: 10/23/2014
• Status: Active Grant

• Current Assignee: Caisson Interventional, LLC (LivaNova Plc)
• Original Assignee: Caisson Interventional, LLC (LivaNova Plc)
• Inventors: Ganesan, Kavitha, Venkatasubramanian, Ramji, Forsberg, Andrew T., Schweich, Jr., Cyril J., Mortier, Todd J., Martz, Erik O., Krone, Douglas J.
• Primary Examiner(s): Severson, Ryan J
• Application Number:
  US14/671,577
• Publication Number:
  US 20160113765A1
• Time in Patent Office: 893 Days
• 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 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2250/006 modular

Abstract

Prosthetic mitral valves described herein can be deployed using a transcatheter mitral valve delivery system and technique to interface and anchor in cooperation with the anatomical structures of a native mitral valve. This document describes prosthetic heart valve designs that interface with native mitral valve structures to create a fluid seal, thereby minimizing mitral regurgitation and paravalvular leaks. This document also describes prosthetic heart valve designs and techniques to manage blood flow through the left ventricular outflow tract. In addition, this document describes prosthetic heart valve designs and techniques that reduce the risk of interference between the prosthetic valves and chordae tendineae.

Claims

1. A method for deploying a prosthetic mitral valve system within a native mitral valve of a patient, the method comprising:

navigating a first delivery sheath within the patient such that a distal end of the first delivery sheath is positioned within a left atrium;

expressing an anchor assembly of the prosthetic mitral valve system from the distal end of the first delivery sheath such that the anchor assembly at least partially expands while located within the left atrium;

after expressing the anchor assembly within the left atrium, moving the anchor assembly towards an annulus of the native mitral valve; and

expressing a valve assembly of the prosthetic mitral valve system from a distal end of a second delivery sheath such that a distal end of the valve assembly at least partially expands while located within the left atrium.

2. The method of claim 1, further comprising:

after expressing the anchor assembly within the left atrium, rotating the anchor assembly within the left atrium;

after rotating the anchor assembly within the left atrium, performing said moving the anchor assembly towards the annulus of the native mitral valve by longitudinally pushing the anchor assembly to a position within the annulus of the native mitral valve; and

engaging the anchor assembly with tissue proximate to the native mitral valve.

3. The method of claim 1, further comprising:

before expressing the valve assembly, navigating the second delivery sheath within the patient such that the distal end of the second delivery sheath is positioned within the left atrium;

after the valve assembly at least partially expands while located within the left atrium, moving the valve assembly into an interior space defined by the anchor assembly; and

after moving the valve assembly, expanding the valve assembly to mate with the anchor assembly.

4. The method of claim 3, wherein said expressing a valve assembly of the prosthetic mitral valve system from the distal end of the second delivery sheath occurs after the anchor assembly is anchored to tissue proximate to the native mitral valve.

5. The method of claim 4, wherein the valve assembly comprises a second expandable frame that is separately expandable from a first expandable frame of the anchor assembly, the second expandable frame of the valve assembly further comprising:

a generally D-shaped outer peripheral region, and a circular valve orifice located radially inward from the generally D-shaped outer peripheral region and carrying valve leaflets that define a circular perimeter at the circular valve orifice.

6. The method of claim 1, wherein when the anchor assembly is engaged with the native mitral valve, native leaflets of the native mitral valve continues to function without significant interference from the anchor assembly.

7. A method for deploying a prosthetic mitral valve system within a native mitral valve of a patient, the method comprising:

navigating a delivery sheath such that a distal end of the delivery sheath is positioned within a left atrium of the patient;

expressing, in the left atrium, an anchor assembly of the prosthetic mitral valve system, wherein a distal pusher instrument is releasably engaged with the anchor assembly;

engaging the anchor assembly with the native mitral valve while the distal pusher instrument remains engaged with the anchor assembly;

expressing, in the left atrium, a valve assembly of the prosthetic mitral valve system, the valve assembly being slidably engaged with an exterior of the distal pusher instrument;

moving the valve assembly into an interior space defined by the anchor assembly, wherein the moving comprises sliding the valve assembly along the exterior of the distal pusher catheter while the distal pusher catheter remains engaged with the anchor assembly;

after moving the valve assembly, mounting the valve assembly with the anchor assembly; and

after mounting the valve assembly, decoupling the distal pusher instrument from the anchor assembly.

8. The method of claim 7, wherein the valve assembly is releasably coupled to a control catheter that defines a lumen, and wherein the valve assembly is slidably engaged with an exterior of the distal pusher instrument by slidably disposing the distal pusher instrument within the lumen of the control catheter.

9. A method for deploying a prosthetic mitral valve system within a native mitral valve of a patient, the method comprising:

expanding an anchor assembly of the prosthetic mitral valve system within a left atrium, while the anchor assembly is releasably secured to a first delivery catheter, such that the anchor assembly at least partially expands while located within the left atrium; and

after expanding the anchor assembly within the left atrium, panning or rotating the anchor assembly within the left atrium by articulating a tip portion of the first delivery catheter.

10. The method of claim 9, further comprising longitudinally advancing the anchor assembly towards an annulus of the native mitral valve after expressing the anchor assembly within the left atrium.

11. The method of claim 10, wherein said longitudinally advancing the anchor assembly towards the annulus of the native mitral valve comprises longitudinally pushing the anchor assembly to a position within the annulus of the native mitral valve so that the anchor assembly engages with tissue proximate to the native mitral valve.

12. The method of claim 11, wherein when the anchor assembly is engaged with the native mitral valve, native leaflets of the native mitral valve continues to function without significant interference from the anchor assembly.

13. The method of claim 12, further comprising:

expressing a valve assembly of the prosthetic mitral valve system within a left atrium, while the valve assembly is releasably secured to a second delivery catheter, such that the valve assembly at least partially expands while located within the left atrium;

after the valve assembly at least partially expands while located within the left atrium, moving the valve assembly into a position radially inward of the anchor assembly; and

after moving the valve assembly, expanding the valve assembly to mount with the anchor assembly.

14. The method of claim 13, wherein said expressing a valve assembly of the prosthetic mitral valve system occurs after the anchor assembly is anchored to tissue proximate to the native mitral valve.

15. The method of claim 13, wherein the valve assembly comprises a second expandable frame that is separately expandable from a first expandable frame of the anchor assembly, the second expandable frame of the valve assembly further comprising:

a generally D-shaped outer peripheral region, and a circular valve orifice located radially inward from the generally D-shaped outer peripheral region and carrying valve leaflets that define a circular perimeter at the circular valve orifice.

16. A method for deploying a prosthetic mitral valve system within a native mitral valve of a patient, the method comprising:

expressing a valve assembly of the prosthetic mitral valve system within a left atrium, while the valve assembly is releasably secured to a valve delivery catheter, such that the valve assembly at least partially expands while located within the left atrium; and

after expressing the valve assembly within the left atrium, panning or rotating the valve assembly within the left atrium by articulating a tip portion of the valve delivery catheter.

17. The method of claim 16, further comprising longitudinally advancing the valve assembly towards an annulus of the native mitral valve after expressing the valve assembly within the left atrium.

18. The method of claim 17, wherein said longitudinally advancing the valve assembly towards the annulus of the native mitral valve comprises longitudinally pushing the valve assembly to a position radially inward of an anchor assembly previously engaged with tissue proximate to the native mitral valve.

19. The method of claim 16, further comprising:

expanding an anchor assembly of the prosthetic mitral valve system within the left atrium, while the anchor assembly is releasably secured to a first delivery catheter, such that the anchor assembly at least partially expands while located within the left atrium; and

after expanding the anchor assembly within the left atrium, panning or rotating the anchor assembly within the left atrium by articulating a tip portion of the first delivery catheter.

20. The method of claim 19, wherein when the anchor assembly is engaged with the native mitral valve, native leaflets of the native mitral valve continues to function without significant interference from the anchor assembly.

21. The method of claim 19, wherein said expressing a valve assembly of the prosthetic mitral valve system occurs after the anchor assembly is anchored to tissue proximate to the native mitral valve.

22. The method of claim 19, wherein the valve assembly comprises a second expandable frame that is separately expandable from a first expandable frame of the anchor assembly, the second expandable frame of the valve assembly further comprising:

a generally D-shaped outer peripheral region, and a circular valve orifice located radially inward from the generally D-shaped outer peripheral region and carrying valve leaflets that define a circular perimeter at the circular valve orifice.