Sequentially deployed transcatheter mitral valve prosthesis

• US 9,713,529 B2
• Filed: 02/17/2016
• Issued: 07/25/2017
• Est. Priority Date: 04/28/2011
• Status: Active Grant

• Current Assignee: Neovasc Tiara Incorporated (Neovasc Incorporated)
• Original Assignee: Neovasc Tiara Incorporated (Neovasc Incorporated)
• Inventors: Marko, Alexei J., Neale, Krista L., Lane, Randy Matthew, Nyuli, Colin A.
• Primary Examiner(s): HOLWERDA, KATHLEEN SONNETT
• Application Number:
  US15/046,371
• Publication Number:
  US 20160157999A1
• Time in Patent Office: 524 Days
• Field of Search: 623 211- 218
• CPC Class Codes: A61F 2/2403 with pivoting rigid closure members check valves with hinged closure members in general F16K15/03
• 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 2/243 Deployment by mechanical expansion
• 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 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• 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 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

A sequentially deployed prosthetic cardiac valve includes a self-expanding frame having an atrial skirt, a ventricular skirt, and an annular region disposed therebetween. A first anterior tab is disposed on an anterior portion of the frame. A posterior tab is on a posterior portion of the self-expanding frame. The frame may be designed so that any portion may expand sequentially in any desired order. For example, a portion of the first anterior tab and a portion of the posterior tab may partially self-expand first. Next, the first anterior tab may fully self-expand before the posterior tab fully self-expands. The posterior tab may fully self-expand next followed by the ventricular skirt, or the ventricular skirt may self-expand next followed by full expansion of the posterior tab.

Claims

1. A method of delivering an implantable prosthetic valve to a patient'"'"'s heart, the patient'"'"'s heart having a mitral valve with an anterior leaflet and a posterior leaflet, said 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, a posterior tab on a posterior portion of the expandable frame, and a ventricular skirt adjacent the first end of the expandable frame, and

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

delivering the prosthetic valve in the collapsed configuration to the patient'"'"'s heart adjacent the mitral valve;

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

wherein the anterior leaflet and adjacent anterior chordae tendineae are disposed between the first anterior tab and an outer anterior surface of the ventricular skirt;

after radially expanding the first anterior tab, radially expanding the posterior tab outward such that the posterior leaflet of the mitral valve and adjacent posterior chordae tendinae are disposed between the posterior tab and an outer posterior surface of the ventricular skirt;

after radially expanding the posterior tab, radially expanding the ventricular skirt outward thereby engaging the anterior and posterior leaflets,

wherein the anterior leaflet and the adjacent anterior chordae tendinae are captured between the first anterior tab and the outer anterior surface of the ventricular skirt, and

wherein the posterior leaflet and the adjacent posterior chordae tendinae are captured between the posterior tab and the posterior outer surface of the ventricular skirt.

2. The method of claim 1, further comprising providing a delivery catheter, wherein the prosthetic valve is releasably coupled thereto.

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

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

5. The method of claim 1, wherein delivering the prosthetic valve comprises positioning the prosthetic valve across the mitral valve so that the first end of the expandable frame is inferior to a portion of the mitral valve and the second end of the expandable frame is superior to a portion of the mitral valve.

6. The method of claim 1, wherein expanding the first anterior tab comprises retracting a constraining sheath from the first anterior tab so that the first anterior tab is free 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, the method further comprising 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, and

wherein the anterior leaflet and adjacent anterior chordae tendineae are disposed between the second anterior tab and the outer anterior surface of the ventricular skirt.

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 prior to engaging the first fibrous trigone or the second fibrous trigone with the respective first or second anterior tab, and prior to disposing the anterior leaflet and the adjacent chordae tendineae between the first or second anterior tab and the outer anterior surface of the ventricular skirt, the method comprises partially expanding the first or the second anterior tab radially outward such that the first or the second anterior tab is transverse to a longitudinal axis of the prosthetic valve.

10. 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.

11. The method of claim 1, wherein prior to disposing the posterior leaflet of the mitral valve and the adjacent posterior chordae tendineae between the posterior tab and the outer posterior surface of the ventricular skirt, the method comprises partially expanding the posterior tab radially outward such that the posterior tab is transverse to a longitudinal axis of the prosthetic valve.

12. The method of claim 1, wherein after the anterior leaflet and the adjacent anterior chordae tendineae are disposed between the first anterior tab and the outer anterior surface of the ventricular skirt, the method comprises partially expanding the posterior tab radially outward such that the posterior tab is transverse to a longitudinal axis of the prosthetic valve, and wherein the posterior tab is partially expanded without disposing the posterior leaflet of the mitral valve and the adjacent posterior chordae tendinae between the posterior tab and the outer posterior surface of the ventricular skirt.

13. The method of claim 1, wherein radially 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.

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

15. The method of claim 1, wherein the prosthetic valve further comprises a plurality of commissures, and wherein expanding the ventricular skirt displaces the anterior and posterior mitral valve leaflets radially outward thereby preventing interference between the commissures and both of the anterior and posterior leaflets.

16. The method of claim 1, wherein expanding the ventricular skirt displaces the anterior and posterior valve leaflets radially outward without contacting an inner wall of the left ventricle, and without obstructing a left ventricular outflow tract.

17. The method of claim 1, 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.

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

19. 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.

20. 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.

21. The method of claim 20, wherein aligning the alignment element comprises rotating the prosthetic valve.

22. 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.

23. The method of claim 22, 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.

24. The method of claim 1, wherein the prosthetic valve further comprises an atrial skirt, the method further comprising:

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

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

25. The method of claim 24, 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.

26. The method of claim 24, further comprising moving the prosthetic valve upstream or downstream relative to the mitral valve to ensure that the atrial skirt engages the superior surface of the mitral valve.

27. The method of claim 24, wherein engaging the atrial skirt against the superior surface seals the atrial skirt against the superior surface of the mitral valve to prevent or substantially prevent blood flow therebetween.

28. The method of claim 1, wherein the prosthetic valve further comprises an annular region, the method further comprising:

expanding the annular region radially outward so as to conform with an annulus of the mitral valve; and

engaging the annular region with the mitral valve annulus.

29. The method of claim 28, wherein expanding the annular region comprises retracting a constraining sheath from the annular region so that the annular region is free to self-expand radially outward.

30. The method of claim 28, 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.