Sequentially deployed transcatheter mitral valve prosthesis

• US 9,308,087 B2
• Filed: 11/16/2012
• Issued: 04/12/2016
• Est. Priority Date: 04/28/2011
• Status: Active Grant

• Current Assignee: Neovasc Tiara Incorporated (Johnson & Johnson)
• Original Assignee: Neovasc Tiara Incorporated (Johnson & Johnson)
• Inventors: Lane, Randy Matthew, Marko, Alexei J., Neale, Krista L., Nyuli, Colin A.
• Primary Examiner(s): HOLWERDA, KATHLEEN SONNETT
• Application Number:
  US13/679,920
• Publication Number:
  US 20130211508A1
• Time in Patent Office: 1,243 Days
• Field of Search: 623/2.14, 623 217- 219
• US Class Current: 1/1
• 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 sequentially deployed prosthetic cardiac valve system, said system comprising:

an outer sheath;

a self-expanding frame disposed at least partially in the outer sheath, the self-expanding frame comprising a first end, a second end opposite the first end, an atrial region near the second end, and a ventricular region near the first end,

wherein the self-expanding frame has an expanded configuration and a collapsed configuration, the expanded configuration adapted to engage heart tissue, and the collapsed configuration adapted to be delivered to a patient'"'"'s heart;

a self-expanding atrial skirt disposed in the atrial region;

a self-expanding ventricular skirt disposed in the ventricular region, the self-expanding ventricular skirt having struts with a length;

a self-expanding annular region disposed between the atrial region and the ventricular region;

a first self-expanding anterior tab disposed on an anterior portion of the self-expanding frame in the ventricular region, the first self-expanding anterior tab having struts with a length shorter than the length of the struts in the ventricular skirt; and

a self-expanding posterior tab on a posterior portion of the self-expanding frame in the ventricular region, the self-expanding posterior tab having struts with a length longer than the length of the struts in the ventricular skirt,

wherein a portion of the first self-expanding anterior tab and a portion of the self-expanding posterior tab begin partially self-expanding concurrently and radially outward when the sheath is partially removed therefrom, and

wherein the first anterior tab fully self-expands radially outward when the sheath is completely removed therefrom, and the first anterior tab fully self-expands before the posterior tab fully expands, and

wherein the first anterior tab fully self-expands before the ventricular skirt fully self-expands radially outward.

2. The system of claim 1, wherein at least a portion of the atrial skirt is covered with tissue or a synthetic material.

3. The system of claim 1, wherein the atrial skirt has a collapsed configuration and an expanded configuration, the collapsed configuration adapted for delivery to the patient'"'"'s heart, and the expanded configuration radially expanded relative to the collapsed configuration and adapted to lie over a superior surface of a patient'"'"'s native mitral valve, thereby anchoring the atrial skirt against a portion of the left atrium.

4. The system of claim 1, wherein the atrial skirt comprises one or more radiopaque markers.

5. The system of claim 1, wherein the atrial skirt comprises a plurality of axially oriented struts connected together with a connector element, the plurality of interconnected struts forming a series of peaks and valleys.

6. The system of claim 1, wherein after self-expansion of the atrial skirt, the atrial skirt forms a flanged region adjacent the second end of the self-expanding frame.

7. The system of claim 1, wherein after self-expanding, the atrial skirt has an asymmetrically D-shaped cross-section having a substantially flat anterior portion, and a cylindrically shaped posterior portion.

8. The system of claim 1, further comprising an alignment element coupled to an anterior portion of the atrial skirt, wherein the alignment element is adapted to be aligned with an aortic root of the patient'"'"'s heart and adapted to be disposed between two fibrous trigones of an anterior leaflet of a patient'"'"'s mitral valve.

9. The system of claim 1, wherein at least a portion of the annular region is covered with tissue or a synthetic material.

10. The system of claim 1, wherein the annular region has a collapsed configuration and an expanded configuration, the collapsed configuration adapted for delivery to the patient'"'"'s heart, and the expanded configuration radially expanded relative to the collapsed configuration and adapted to conform with and to engage an annulus of a patient'"'"'s native mitral valve.

11. The system of claim 1, wherein after self-expanding, the annular region has an asymmetrically D-shaped cross-section having a substantially flat anterior portion, and a cylindrically shaped posterior portion.

12. The system of claim 1, wherein the annular region comprises a plurality of axially oriented struts connected together with a connector element, the plurality of interconnected struts forming a series of peaks and valleys.

13. The system of claim 12, wherein one or more of the plurality of axially oriented struts comprise one or more suture holes extending therethrough, the suture holes sized to receive a suture.

14. The system of claim 1, wherein at least a portion of the ventricular skirt is covered with tissue or a synthetic material.

15. The system of claim 1, wherein after self-expanding, the ventricular skirt comprises an asymmetrically D-shaped cross-section having a substantially flat anterior portion, and a cylindrically shaped posterior portion.

16. The system of claim 1, wherein the ventricular skirt has a collapsed configuration and an expanded configuration, the collapsed configuration adapted for delivery to the patient'"'"'s heart, and the expanded configuration radially expanded relative to the collapsed configuration and adapted to displace native mitral valve leaflets radially outward.

17. The system of claim 1, wherein the first anterior tab has a tip portion adapted to engage a first fibrous trigone on a first side of an anterior leaflet of a patient'"'"'s mitral valve, and wherein the first anterior tab is adapted to capture the anterior leaflet and adjacent chordae tendineae between the first anterior tab and an outer anterior surface of the ventricular skirt.

18. The system of claim 17, wherein the prosthetic cardiac valve further comprises a second self-expanding anterior tab disposed on the anterior portion of the self-expanding frame in the ventricular region, and wherein the second anterior tab has a tip portion adapted to engage a second fibrous trigone on a second side of the anterior leaflet of the patient'"'"'s mitral valve opposite the first side of the anterior leaflet, and wherein the second anterior tab is adapted to capture the anterior leaflet and adjacent chordae tendineae between the second anterior tab and the outer anterior surface of the ventricular skirt.

19. The system of claim 18, further comprising a covering disposed over the first or the second anterior tab, the covering increasing contact surface area of the respective first or second anterior tab with the heart tissue.

20. The system of claim 19, wherein the covering comprises a fabric material disposed over a polymer tab that is coupled to the first or the second anterior tab.

21. The system of claim 1, wherein the posterior tab is adapted to being anchored over a posterior leaflet of the patient'"'"'s mitral valve, such that the posterior tab is seated between the posterior leaflet and a ventricular wall of a patient'"'"'s heart.

22. The system of claim 1, wherein the struts of the posterior tab comprise a plurality of struts, wherein adjacent struts are coupled together to form a plurality of expandable hinged joints, and wherein upon radial expansion of the posterior tab, the plurality of struts move away from one another thereby opening the hinged joints and forming an elongate horizontal section which allows engagement and anchoring of the posterior tab with a sub-annular region of the mitral valve between the posterior leaflet and the ventricular wall.

23. The system of claim 1, wherein the ventricular skirt further comprises a plurality of barbs coupled thereto, the plurality of barbs adapted to anchor the ventricular skirt into heart tissue.

24. The system of claim 1, wherein the struts of the ventricular skirt comprise a plurality of struts connected together with a connector element, the plurality of interconnected struts forming a series of peaks and valleys.

25. The system of claim 24, wherein one or more of the struts of the ventricular skirt comprise one or more suture holes extending therethrough, the suture holes sized to receive a suture.

26. The system of claim 1, further comprising a plurality of prosthetic valve leaflets, each of the leaflets having a first end and a free end, wherein the first end is coupled with the self-expanding frame and the free end is opposite of the first end, wherein the prosthetic valve leaflets have 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.

27. The system of claim 26, wherein the plurality of prosthetic valve leaflets form a tricuspid valve.

28. The system of claim 26, wherein at least a portion of one or more of the prosthetic valve leaflets comprises tissue or a synthetic material.

29. The system of claim 26, wherein one or more of the prosthetic valve leaflets comprise a commissure post having a commissure tab, the commissure tab adapted to be releasably engaged with a delivery device.

30. The system of claim 1, wherein the prosthetic cardiac valve carries a therapeutic agent, the therapeutic agent is adapted to being eluted therefrom.

31. The system of claim 1, wherein the atrial skirt completely self-expands before the first anterior tab self-expands.

32. The system of claim 1, wherein the atrial skirt completely self-expands before the posterior tab self-expands.