Transcatheter mitral valve prosthesis

• US 8,579,964 B2
• Filed: 04/28/2011
• Issued: 11/12/2013
• Est. Priority Date: 05/05/2010
• Status: Active Grant

• Current Assignee: Neovasc Tiara Incorporated (Neovasc Incorporated)
• Original Assignee: Neovasc Incorporated
• Inventors: Lane, Randy Matthew, Nyuli, Colin A.
• Primary Examiner(s): EREZO, DARWIN P
• Application Number:
  US13/096,572
• Publication Number:
  US 20110319989A1
• Time in Patent Office: 929 Days
• Field of Search: 623/2.1, 623 211- 219, 623 238- 24
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2412 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 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2002/9505 having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
• 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 2230/0034 D-shaped
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

A prosthetic cardiac valve comprises an anchor having an atrial skirt, an annular region, and a ventricular skirt. The prosthetic valve also has a plurality of prosthetic valve leaflets each having a first end and a free end. The first end is coupled with the anchor and the free end is opposite the first end. The prosthetic cardiac valve has an open configuration in which the free ends of the prosthetic valve leaflets are disposed away from one another to allow antegrade blood flow therepast, and a closed configuration in which the free ends of the prosthetic valve leaflets engage one another and substantially prevent retrograde blood flow therepast. The anchor has a collapsed configuration for delivery to the heart and an expanded configuration for anchoring the prosthetic cardiac valve to a patient'"'"'s heart.

Claims

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

providing the prosthetic valve, wherein the prosthetic valve comprises an anchor having an atrial skirt, an annular region, a ventricular skirt, and a plurality of valve leaflets, wherein the ventricular skirt comprises a first trigonal anchoring tab disposed on an anterior portion of the ventricular skirt, wherein the anchor has a collapsed configuration for delivery to the heart and an expanded configuration for anchoring with the heart;

positioning the prosthetic valve in the patient'"'"'s heart;

expanding the atrial skirt radially outward so as to lie over a superior surface of the patient'"'"'s native mitral valve, and anchoring the atrial skirt against a portion of the atrium;

radially expanding the annular region of the anchor to conform with and to engage the native mitral valve annulus;

anchoring the first trigonal anchoring tab against a first fibrous trigone on a first side of an anterior leaflet of the native mitral valve, such that the anterior leaflet and adjacent chordae tendineae are captured between the trigonal anchoring tab and an anterior surface of the anchor; and

radially expanding the ventricular skirt thereby displacing the native mitral valve leaflets radially outward.

2. The method of claim 1, wherein at least a portion of the prosthetic valve is covered with tissue or a synthetic material.

3. The method of claim 1, wherein positioning the prosthetic valve comprises transseptally delivering the prosthetic valve from the right atrium to the left atrium of the heart.

4. The method of claim 1, wherein positioning the prosthetic valve comprises transapically delivering the prosthetic valve from a region outside the heart to the left ventricle of the heart.

5. The method of claim 1, wherein expanding the atrial skirt comprises slidably moving a restraining sheath away from the atrial skirt thereby allowing radial expansion thereof.

6. The method of claim 5, wherein the atrial skirt self-expands when the restraining sheath is removed therefrom.

7. The method of claim 1, further comprising applying a force on the prosthetic valve to ensure that the atrial skirt engages the superior surface of the mitral valve.

8. The method of claim 1, wherein the atrial skirt comprises a plurality of barbs, and wherein expanding the atrial skirt comprises anchoring the barbs into the superior surface of the mitral valve.

9. The method of claim 1, wherein expanding the atrial skirt comprises sealing the atrial skirt against the superior surface of the native mitral valve.

10. The method of claim 1, wherein radially expanding the annular region comprises slidably moving a restraining sheath away from the annular region thereby allowing radial expansion thereof.

11. The method of claim 10, wherein the annular region self-expands when the restraining sheath is removed therefrom.

12. The method of claim 1, wherein radially 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.

13. The method of claim 1, wherein the ventricular skirt further comprises a second trigonal anchoring tab on the anterior portion of the ventricular skirt, and the method further comprises anchoring the second trigonal anchoring tab against a second fibrous trigone opposite the first fibrous trigone, such that the native anterior leaflet and adjacent chordae tendineae are captured between the second trigonal anchoring tab and an anterior surface of the anchor.

14. The method of claim 1, wherein the ventricular skirt further comprises a posterior ventricular anchoring tab on a posterior portion of the ventricular skirt, and wherein radially expanding the ventricular skirt comprises anchoring the posterior ventricular anchoring tab over a posterior leaflet of the native mitral valve to seat between the posterior leaflet and a ventricular wall of the heart.

15. The method of claim 1, wherein radially expanding the ventricular skirt comprises slidably moving a restraining sheath away from the ventricular skirt thereby allowing radial expansion thereof.

16. The method of claim 15, wherein the ventricular skirt self-expands when the restraining sheath is removed therefrom.

17. The method of claim 1, wherein the ventricular skirt comprises a plurality of barbs, and wherein expanding the ventricular skirt comprises anchoring the barbs into heart tissue.

18. The method of claim 1, wherein the prosthetic valve comprises a plurality of prosthetic valve leaflets, and wherein radially expanding the ventricular skirt comprises displacing the native mitral valve leaflets radially outward thereby preventing interference of the native mitral valve leaflets with the prosthetic valve leaflets.

19. The method of claim 1, wherein radially expanding the ventricular skirt comprises displacing the native mitral valve leaflets radially outward without contacting a ventricular wall, and without obstructing a left ventricular outflow tract.

20. The method of claim 1, wherein radially expanding the ventricular skirt comprises asymmetrically expanding the ventricular skirt such that an anterior portion of the ventricular skirt is substantially flat, and a posterior portion of the ventricular skirt is cylindrically shaped.

21. The method of claim 1, wherein the atrial skirt comprises an alignment element, the method further comprising aligning the alignment element relative to the patient'"'"'s valve.

22. The method of claim 21, wherein the valve comprises a mitral valve, and wherein aligning comprises aligning the alignment element with an aortic root and disposing the alignment element between two fibrous trigones of an anterior leaflet of the mitral valve.

23. The method of claim 21, wherein aligning comprises rotating the prosthetic valve.

24. The method of claim 1, wherein the prosthetic valve comprises a plurality of prosthetic leaflets coupled to commissures, the method further comprising releasing the commissures from a delivery catheter.

25. The method of claim 24, wherein the prosthetic valve comprises a tricuspid leaflet configuration.

26. The method of claim 1, wherein the prosthetic valve has an open configuration in which the prosthetic valve leaflets are disposed away from one another, and the prosthetic valve has a closed configuration in which the prosthetic valve leaflets engage one another, and wherein blood flows freely through the prosthetic valve in the open configuration, and wherein retrograde blood flow across the prosthetic valve is substantially prevented in the closed configuration.

27. The method of claim 1, further comprising reducing or eliminating mitral regurgitation.

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