Transcatheter mitral valve prosthesis

• US 9,241,790 B2
• Filed: 04/13/2015
• Issued: 01/26/2016
• Est. Priority Date: 05/05/2010
• Status: Active Grant

• Current Assignee: Neovasc Tiara Incorporated (Neovasc Incorporated)
• Original Assignee: Neovasc Tiara Incorporated (Neovasc Incorporated)
• Inventors: Lane, Randy Matthew, Nyuli, Colin A.
• Primary Examiner(s): Miles, Jonathan W
• Assistant Examiner(s): Ulsh, George J
• Application Number:
  US14/685,418
• Publication Number:
  US 20150216655A1
• Time in Patent Office: 288 Days
• Field of Search: 623/2.11, 623 214- 219, 623/2.38
• US Class Current: 1/1
• 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 having a native mitral valve, said method comprising:

delivering a prosthetic cardiac mitral valve in a collapsed configuration to the patient'"'"'s heart, wherein the prosthetic cardiac mitral valve comprises an anchor having a first anterior trigonal anchoring tab disposed on an anterior portion of the prosthetic cardiac mitral valve;

radially expanding the anchor from the collapsed configuration to an expanded configuration to engage the native mitral valve;

anchoring the prosthetic cardiac mitral valve to the native mitral valve, wherein anchoring the prosthetic cardiac mitral valve comprises expanding the first anterior trigonal anchoring tab radially outward and engaging the first anterior trigonal anchoring tab against a first fibrous trigone of the native mitral valve; and

disposing adjacent chordae tendineae between the first anterior trigonal anchoring tab and an anterior surface of the anchor.

2. The method of claim 1, wherein expanding the first anterior trigonal anchoring tab radially outward and engaging the first anterior trigonal anchoring tab against the first fibrous trigone of the native mitral valve comprises disposing an anterior leaflet of the native mitral valve between the first anterior trigonal anchoring tab and an anterior surface of the anchor.

3. The method of claim 1, wherein the prosthetic cardiac mitral valve further comprises a second anterior trigonal anchoring tab disposed on the anterior portion of the prosthetic cardiac mitral valve, and wherein anchoring the prosthetic cardiac mitral valve further comprises expanding the second anterior trigonal anchoring tab radially outward and engaging the second anterior trigonal anchoring tab against a second fibrous trigone of the native mitral valve.

4. The method of claim 3, wherein expanding the second anterior trigonal anchoring tab radially outward and engaging the second anterior trigonal anchoring tab against the second fibrous trigone of the native mitral valve comprises disposing an anterior leaflet of the native mitral valve between the second anterior trigonal anchoring tab and an anterior surface of the anchor.

5. The method of claim 3, wherein expanding the second anterior trigonal anchoring tab radially outward and engaging the second anterior trigonal anchoring tab against the second fibrous trigone of the native mitral valve comprises disposing adjacent chordae tendineae between the second anterior trigonal anchoring tab and an anterior surface of the anchor.

6. The method of claim 1, wherein the anchor further comprises a posterior anchoring tab disposed on a posterior portion of the prosthetic cardiac mitral valve, and wherein anchoring the prosthetic cardiac mitral valve further comprises expanding the posterior anchoring tab radially outward and engaging the posterior anchoring tab with a posterior portion of the native mitral valve.

7. The method of claim 1, wherein positioning the prosthetic cardiac mitral valve in the patient'"'"'s heart comprises transseptally delivering the prosthetic cardiac mitral valve from the right atrium to the left atrium of the heart.

8. The method of claim 1, wherein positioning the prosthetic cardiac mitral valve in the patient'"'"'s heart comprises transapically delivering the prosthetic cardiac mitral valve from a region outside the heart to the left ventricle of the heart.

9. The method of claim 1, wherein the anchor further comprises an atrial skirt, and wherein expanding the anchor from the collapsed configuration to the expanded configuration to engage the native mitral valve comprises 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.

10. The method of claim 9, wherein expanding the atrial skirt comprises slidably moving a restraining sheath away from the atrial skirt thereby allowing radial expansion thereof.

11. The method of claim 9, further comprising applying a force on the prosthetic cardiac mitral valve to ensure that the atrial skirt engages the superior surface of the native mitral valve.

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

13. The method of claim 9, wherein the atrial skirt comprises an alignment element, the method further comprising aligning the alignment element relative to the patient'"'"'s native mitral valve.

14. The method of claim 13, wherein aligning comprises aligning the alignment element with an aortic root and disposing the alignment element between the first fibrous trigone and a second fibrous trigone of the native mitral valve.

15. The method of claim 1, wherein the anchor further comprises an annular region, and wherein expanding the anchor from the collapsed configuration to the expanded configuration to engage the native mitral valve comprises radially expanding the annular region of the anchor to conform with and to engage the native mitral valve annulus.

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

17. The method of claim 15, 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.

18. The method of claim 1, wherein the anchor comprises a ventricular skirt, and wherein expanding the anchor from the collapsed configuration to the expanded configuration to engage the native mitral valve comprises radially expanding the ventricular skirt thereby displacing native leaflets of the native mitral valve radially outward.

19. The method of claim 18, wherein radially expanding the ventricular skirt comprises slidably moving a restraining sheath away from the ventricular skirt thereby allowing radial expansion thereof.

20. The method of claim 18, wherein the prosthetic cardiac mitral valve further 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.

21. The method of claim 18, wherein radially expanding the ventricular skirt comprises displacing the native mitral valve leaflets radially outward without contacting a ventricular wall of the patient'"'"'s heart, and without obstructing a left ventricular outflow tract.

22. The method of claim 18, 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.

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

24. The method of claim 23, wherein the the plurality of prosthetic valve leaflets form a tricuspid leaflet configuration.

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

26. The method of claim 1, further comprising reducing or eliminating mitral regurgitation in the patient after implantation of the prosthetic cardiac mitral valve in the patient'"'"'s heart.

27. The method of claim 1, wherein radially expanding the anchor from the collapsed configuration to an expanded configuration comprises slidably moving a restraining sheath away from the anchor, allowing at least a portion of the anchor to self-expand.

28. The method of claim 1, wherein the first anterior trigonal anchoring tab comprises two struts originating from a ventricular skirt disposed on a ventricular portion of the anchor, and joined by a u-shaped connector.