Methods and apparatus for delivering a prosthetic valve to a beating heart

• US 10,383,728 B2
• Filed: 01/11/2017
• Issued: 08/20/2019
• Est. Priority Date: 04/04/2013
• Status: Active Grant

• Current Assignee: Neovasc Tiara Incorporated (Neovasc Incorporated)
• Original Assignee: Neovasc Tiara Incorporated (Neovasc Incorporated)
• Inventors: Lane, Randy Matthew, Marko, Alexei J., Nyuli, Colin A., Neale, Krista L.
• Primary Examiner(s): Severson, Ryan J.
• Application Number:
  US15/404,012
• Publication Number:
  US 20170209266A1
• Time in Patent Office: 951 Days
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• 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 2230/0034 D-shaped
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/362 Heart stimulators heart defibrillators A61N1/39

Abstract

A method for delivering a prosthetic valve to a patient'"'"'s heart having a native valve with a plurality of valve leaflets includes providing a delivery device with a prosthetic valve, advancing the delivery device toward the native valve, and expanding a portion of the prosthetic valve to form a flanged region that is upstream of the valve leaflets. One or more tabs on the prosthetic valve are released so that they expand outward to a position that is transverse to the longitudinal axis of the prosthetic valve. The position of the prosthetic valve is adjusted relative to the valve leaflets and rapid pacing is applied to the patient'"'"'s heart so that the valve leaflets move inward toward the prosthetic valve or the delivery device. The tabs are further released to allow the tabs to move into their final positions.

Claims

1. A method for delivering a prosthetic valve to a patient'"'"'s heart having a native valve with a plurality of valve leaflets, said method comprising:

providing a delivery device having a prosthetic valve with a longitudinal axis;

advancing the delivery device toward the native valve;

expanding a portion of the prosthetic valve to form a flanged region, the flanged region disposed upstream of the valve leaflets;

rotationally aligning the prosthetic valve with the native valve;

rapid pacing the patient'"'"'s heart such that the plurality of valve leaflets move inward toward the prosthetic valve; and

releasing one or more tabs from the prosthetic valve to anchor the valve by disposing at least a portion of the one or more tabs behind at least one of the valve leaflets.

2. The method of claim 1, wherein the delivery device comprises an inner elongate shaft and outer sheath slidably disposed thereover, the prosthetic valve disposed on the inner elongate shaft and constrained by the outer sheath.

3. The method of claim 1, wherein the prosthetic valve is a prosthetic mitral valve having three prosthetic valve leaflets and wherein the native valve is a mitral valve.

4. The method of claim 1, wherein advancing the delivery device comprises transapically advancing the delivery device to the patient'"'"'s native valve.

5. The method of claim 1, wherein advancing the delivery device comprises transseptally advancing the delivery device to the patient'"'"'s native valve.

6. The method of claim 1, wherein an outer sheath is disposed over the prosthetic valve, and wherein expanding the portion of the prosthetic valve comprises retracting the outer sheath thereby allowing the portion of the prosthetic valve to self-expand and form the flanged region.

7. The method of claim 1, further comprising moving the prosthetic valve upstream or downstream relative to the native valve to align the prosthetic valve with the native valve.

8. The method of claim 1, wherein the prosthetic valve comprises a substantially flat anterior portion and a rounded cylindrical posterior portion that forms a D-shaped cross-section, and wherein rotationally aligning the prosthetic valve with the native valve comprises rotating the prosthetic valve about the longitudinal axis so that the flat anterior portion faces toward an anterior portion of the native valve and the rounded cylindrical posterior portion faces toward a posterior portion of the native valve.

9. The method of claim 8, wherein the prosthetic valve is a prosthetic mitral valve, the native valve is a mitral valve, and rotationally aligning the prosthetic valve with the native valve further comprises aligning the D-shaped cross section of the prosthetic mitral valve so that it is axially and rotationally aligned to conform to the anatomy of the native mitral valve.

10. The method of claim 1, wherein rapid pacing comprises disposing a rapid pacing catheter having one or more electrodes into the apex of the patient'"'"'s right ventricle.

11. The method of claim 1, wherein rapid pacing comprises engaging one or more electrodes with the epicardium of the patient'"'"'s heart.

12. The method of claim 1, wherein the rapid pacing accelerates beating of the patient'"'"'s heart to a rate exceeding 170 beats per minute.

13. The method of claim 1, wherein the rapid pacing decreases cardiac output of the heart.

14. The method of claim 1, wherein the rapid pacing is applied for a duration of 20 seconds or less.

15. The method of claim 1, wherein the rapid pacing causes the plurality of valve leaflets to move toward a closed position.

16. The method of claim 1, wherein the rapid pacing causes the plurality of valve leaflets to close around the prosthetic valve or around the delivery device.

17. The method of claim 1, further comprising discontinuing the rapid pacing after the one or more tabs are disposed behind at least one of the plurality of valve leaflets.

18. The method of claim 1, wherein the native valve is a mitral valve, and wherein releasing the one or more tabs comprises moving at least one of the one or more tabs into engagement with a fibrous trigone disposed on an anterior portion of the mitral valve.

19. The method of claim 18, wherein an outer sheath is disposed over the prosthetic valve, and wherein releasing comprises retracting the outer sheath thereby allowing the one or more tabs to self-expand into engagement with the fibrous trigone.

20. The method of claim 1, wherein the native valve is a mitral valve, and wherein releasing the one or more tabs comprises moving at least one of the one or more tabs into engagement with a posterior subvalvar portion of a mitral valve annulus.

21. The method of claim 1, further comprising releasing one or more tabs from the prosthetic valve so the one or more tabs radially expand outward to a position that is transverse relative to the longitudinal axis.

22. The method of claim 21, wherein an outer sheath is disposed over the prosthetic valve, and wherein releasing the one or more tabs comprises retracting the outer sheath thereby allowing the one or more tabs to self-expand outward to their respective transverse position.

23. The method of claim 22, wherein the transverse position is substantially horizontal relative to the longitudinal axis of the prosthetic valve.