Prosthetic valve with anti-pivoting mechanism

• US 10,583,002 B2
• Filed: 03/03/2014
• Issued: 03/10/2020
• Est. Priority Date: 03/11/2013
• Status: Active Grant

• Current Assignee: Neovasc Tiara Incorporated (Neovasc Incorporated)
• Original Assignee: Neovasc Tiara Incorporated (Neovasc Incorporated)
• Inventors: Lane, Randy Matthew, Nyuli, Colin A., Marko, Alexei J., Neale, Krista L.
• Primary Examiner(s): Schwiker, Katherine H
• Application Number:
  US14/195,576
• Publication Number:
  US 20140257467A1
• Time in Patent Office: 2,199 Days
• Field of Search: 623 211
• 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 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• 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: A61F 2230/0065 toroidal, e.g. ring-shaped, doughnut-shaped

Abstract

A prosthetic valve for implanting in a patient'"'"'s native valve has a self-expanding frame that comprises a first end, a second end opposite the first end, an anterior portion, and a posterior portion. The self-expanding frame has an expanded configuration adapted to engage tissue at a treatment site, and a collapsed configuration adapted to be delivered to the treatment site. The expandable frame also comprises a self-expanding atrial skirt near the second end, a self-expanding ventricular skirt near the first end, a self-expanding annular region disposed between first and second ends, a first self-expanding anterior tab disposed on the anterior portion, and a self-expanding foot coupled to the posterior portion and extending radially outward. The foot has an outer surface for engaging the tissue thereby facilitating anchoring of the prosthetic valve and minimizing or preventing rotation of the prosthetic valve.

Claims

1. A method for anchoring a prosthetic valve in a native valve of a patient'"'"'s heart, patient'"'"'s heart, method comprising:

providing a prosthetic valve, wherein the prosthetic valve comprises an expandable frame having a first end, a second end opposite the first end, a first anterior tab on an anterior portion of the expandable frame adjacent the first end, a posterior tab on a posterior portion of the expandable frame adjacent the first end, a foot on a posterior portion of the expandable frame adjacent the first end, a ventricular skirt adjacent the first end of the expandable frame, and an annular region disposed between the first and second ends,

wherein the foot comprises a wedge-shaped element extending laterally and radially outward from a periphery of the ventricular skirt, and the foot comprises a plurality of struts having a length, and

wherein the posterior tab is coupled to and extends from the foot;

wherein the ventricular skirt comprises a plurality of struts having a length, and wherein the length of the plurality of struts in the foot is greater than the length of the plurality of struts in the ventricular skirt,

wherein the prosthetic valve has an expanded configuration for engaging the native valve, and a collapsed configuration;

advancing the prosthetic valve in the collapsed configuration to the native valve;

expanding the first anterior tab radially outward such that a tip of the first anterior tab engages a first fibrous trigone on a first side of an anterior leaflet of the native valve, and

wherein the anterior leaflet is disposed between the first anterior tab and an outer surface of the ventricular skirt;

expanding the posterior tab radially outward and failing to anchor the posterior tab to the native valve;

expanding the foot laterally and radially outward from the ventricular skirt such that the foot engages a posterior portion of the native valve thereby anchoring the prosthetic valve to a posterior portion of the native valve and preventing or minimizing pivoting of the prosthetic valve up into an atrium of the patient'"'"'s heart; and

wherein the wedge-shaped element comprises a covering coupled to at least one of the plurality of struts of the foot that extends radially outward beyond the expandable frame.

2. The method of claim 1, wherein providing the prosthetic valve further comprises providing a delivery device for delivering the prosthetic valve to the native valve, and wherein the prosthetic valve is releasably coupled to the delivery device.

3. The method of claim 1, wherein advancing the prosthetic valve comprises transapically delivering the prosthetic valve from a region outside of the patient to the patient'"'"'s heart.

4. The method of claim 1, wherein advancing the prosthetic valve comprises transseptally delivering the prosthetic valve from the right atrium to the left atrium of the patient'"'"'s heart.

5. The method of claim 1, wherein the native valve is a mitral valve and wherein advancing the prosthetic valve comprises positioning the prosthetic valve across the patient'"'"'s mitral valve so that the first end is inferior to the mitral valve and the second end is superior to the mitral valve.

6. The method of claim 1, wherein expanding the first anterior tab comprises retracting a constraining sheath therefrom and allowing the first anterior tab to self-expand radially outward.

7. The method of claim 1, wherein the prosthetic valve further comprises a second anterior tab on the anterior portion of the expandable frame, and the method further comprises expanding the second anterior tab radially outward such that a tip portion of the second anterior tab engages a second fibrous trigone on a second side of the anterior leaflet opposite the first side of the anterior leaflet.

8. The method of claim 7, wherein the second anterior tab expands radially outward concurrently with expansion of the first anterior tab.

9. The method of claim 7, wherein expanding the second anterior tab comprises retracting a constraining sheath from the second anterior tab so that the second anterior tab is free to self-expand radially outward.

10. The method of claim 1, wherein expanding the foot forms a vestibule adjacent the first end of the prosthetic valve.

11. The method of claim 1, wherein expanding the foot increases the size of the first end of the prosthetic valve so that it cannot pass through the native valve.

12. The method of claim 1, wherein expanding the foot comprises retracting a constraint therefrom so that the foot self-expands radially outward.

13. The method of claim 1, wherein after expanding the foot, the foot engages posterior chordae tendineae on the native heart valve.

14. The method of claim 1, wherein the foot comprises barbs, texturing, or other surface features, and wherein expanding the foot engages the barbs, texturing or other surface features with tissue, thereby anchoring the foot with the tissue.

15. The method of claim 1, further comprising expanding the ventricular skirt radially outward into engagement with the anterior and posterior leaflets of the native valve.

16. The method of claim 15, wherein the first anterior tab and the outer surface of the ventricular skirt engage anterior chordae tendineae of the native heart there between.

17. The method of claim 15, wherein expanding the ventricular skirt comprises retracting a constraining sheath from the ventricular skirt so that the ventricular skirt is free to self-expand radially outward.

18. The method of claim 15, wherein the ventricular skirt comprises a plurality of barbs, and wherein expanding the ventricular skirt comprises anchoring the plurality of barbs into heart tissue.

19. The method of claim 15, wherein the prosthetic valve further comprises a plurality of commissures, and wherein expanding the ventricular skirt displaces anterior and posterior leaflets of the native valve radially outward thereby preventing interference between the commissures and the leaflets.

20. The method of claim 15, wherein expanding the ventricular skirt displaces anterior and posterior leaflets of the native valve radially outward without contacting an inner wall of the left ventricle, and without obstructing a left ventricular outflow tract.

21. The method of claim 15, wherein radially expanding the ventricular skirt expands the ventricular skirt asymmetrically such that an anterior portion of the ventricular skirt is substantially flat, and a posterior portion of the ventricular skirt is cylindrically shaped.

22. The method of claim 1, further comprising expanding the annular region radially outward so as to engage an annulus of the native valve.

23. The method of claim 22, wherein expanding the annular region comprises retracting a constraining sheath therefrom so that the annular region is free to self-expand radially outward.

24. The method of claim 22, wherein expanding the annular region comprises asymmetrically expanding the annular region such that an anterior portion of the annular region is substantially flat, and a posterior portion of the annular region is cylindrically shaped.

25. The method of claim 1, wherein the native valve is a mitral valve, the method further comprising reducing or eliminating mitral regurgitation.

26. The method of claim 1, wherein the prosthetic valve carries a therapeutic agent, and the method further comprises eluting the therapeutic agent from the prosthetic valve into adjacent tissue.

27. The method of claim 1, wherein the prosthetic valve comprises an alignment element, and wherein a second fibrous trigone is disposed on a second side of the anterior leaflet opposite the first side of the anterior leaflet, the method further comprising aligning the alignment element with an aortic root and disposing the alignment element between the first and second fibrous trigones.

28. The method of claim 27, wherein aligning the alignment element comprises rotating the prosthetic valve.

29. The method of claim 1, wherein the prosthetic valve further comprises a plurality of commissures with a covering disposed thereover whereby a plurality of prosthetic valve leaflets are formed, the method further comprising releasing the plurality of prosthetic valve leaflets from a delivery catheter.

30. The method of claim 29, wherein the plurality of prosthetic valve leaflets form a tricuspid valve, the tricuspid valve having an open configuration and a closed configuration, wherein the plurality of prosthetic valve leaflets are disposed away from one another in the open configuration thereby permitting antegrade blood flow therethrough, and wherein the plurality of prosthetic valve leaflets engage one another in the closed configuration thereby substantially preventing retrograde blood flow therethrough.

31. The method of claim 1, wherein the prosthetic valve further comprises an atrial skirt adjacent the second end, the method further comprising:

expanding the atrial skirt radially outward so as to lie over a superior surface of the native valve; and

engaging the atrial skirt against the superior surface of the native valve.

32. The method of claim 31, wherein expanding the atrial skirt comprises retracting a constraining sheath from the atrial skirt so that the atrial skirt is free to self-expand radially outward.

33. The method of claim 31, further comprising moving the prosthetic valve upstream or downstream relative to the native valve to ensure that the atrial skirt engages the superior surface of the native valve.

34. The method of claim 31, wherein engaging the atrial skirt against the superior surface seals the atrial skirt against the superior surface of the native valve to prevent or substantially prevent blood flow therebetween.

35. The method of claim 1, wherein the plurality of struts of the foot comprises a pair of elongate struts.

36. The method of claim 35, wherein the pair of elongate struts are coupled together to form a U-shape or a V-shape.