Transcatheter mitral valve prosthesis

• US 9,248,014 B2
• Filed: 04/21/2015
• Issued: 02/02/2016
• Est. Priority Date: 05/05/2010
• Status: Active Grant

• Current Assignee: Neovasc Tiara Incorporated (Johnson & Johnson)
• Original Assignee: Neovasc Tiara Incorporated (Johnson & Johnson)
• Inventors: Lane, Randy Matthew, Nyuli, Colin A.
• Primary Examiner(s): Miles, Jonathan W
• Assistant Examiner(s): Ulsh, George J
• Application Number:
  US14/692,605
• Publication Number:
  US 20150257878A1
• Time in Patent Office: 287 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 prosthetic mitral valve for anchoring in a patient'"'"'s heart having a native mitral valve, said prosthetic mitral valve comprising:

an anchor having a collapsed configuration for delivery to the heart and an expanded configuration for anchoring the prosthetic mitral valve to the native mitral valve,

wherein the anchor comprises a ventricular skirt comprising a first trigonal anchoring tab disposed on an anterior portion of the ventricular skirt extending radially outward and facing toward an atrium of the patient'"'"'s heart when the anchor is in the expanded configuration, the first trigonal anchoring tab configured to engage a first fibrous trigone on a first side of an anterior leaflet of the patient'"'"'s native mitral valve such that the anterior leaflet is disposed between the first trigonal anchoring tab and an anterior surface of the anchor when the anchor is in the expanded configuration and anchored to the native mitral valve and configured such that adjacent chordae tendineae are disposed between the first trigonal anchoring tab and the anterior surface of the anchor when the anchor is in the expanded configuration and anchored to the native mitral valve.

2. The prosthetic mitral valve of claim 1, wherein the ventricular skirt further comprises a second trigonal anchoring tab disposed on the anterior portion of the ventricular skirt extending radially outward and facing toward the atrium of the patient'"'"'s heart when the anchor is in the expanded configuration, the second trigonal anchoring tab configured to engage a second fibrous trigone on a second side of the anterior leaflet of the patient'"'"'s native mitral valve such that the anterior leaflet is disposed between the second trigonal anchoring tab and the anterior surface of the anchor when the anchor is in the expanded configuration and anchored to the native mitral valve.

3. The prosthetic mitral valve of claim 2, wherein adjacent chordae tendineae are configured to be captured between the second trigonal anchoring tab and the anterior surface of the anchor when the anchor is in the expanded configuration and anchored to the native mitral valve.

4. The prosthetic mitral valve of claim 1, wherein the ventricular skirt further comprises a posterior anchoring tab disposed on a posterior portion of the ventricular skirt extending radially outward and facing toward an atrium of the patient'"'"'s heart to engage a posterior portion of the native mitral valve, wherein the posterior anchoring tab is configured so that a posterior leaflet of the native mitral valve is disposed between the posterior anchoring tab and a posterior outer surface of the ventricular skirt or the anchor when the anchor is in the expanded configuration and anchored to the native mitral valve.

5. The prosthetic mitral valve of claim 1, wherein the prosthetic mitral valve further comprises a plurality of prosthetic valve leaflets coupled to the anchor, each of the leaflets having a first end coupled with the anchor and a free end opposite of the first end, wherein the prosthetic mitral valve when anchored in the native mitral valve in the expanded configuration, 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.

6. The prosthetic mitral valve of claim 5, wherein at least a portion of one or more of the prosthetic valve leaflets comprises tissue or a synthetic material.

7. The prosthetic mitral valve of claim 5, wherein the plurality of prosthetic valve leaflets form a tricuspid leaflet configuration.

8. The prosthetic mitral valve of claim 5, wherein one or more of the prosthetic valve leaflets are coupled to a commissure post coupled to the anchor and having a commissure tab adapted to releasably engage the commissure post with a delivery device.

9. The prosthetic mitral valve of claim 1, wherein the anchor further comprises an atrial skirt configured to expand radially outward so as to lie over a superior surface of the patient'"'"'s native mitral valve and anchor against a portion of the atrium when the anchor is anchored to the native mitral valve in the expanded configuration.

10. The prosthetic mitral valve of claim 9, wherein the atrial skirt comprises an alignment element adapted to be aligned with an aortic root of the patient'"'"'s heart and adapted to be disposed between two fibrous trigones of the anterior leaflet of the patient'"'"'s native mitral valve.

11. The prosthetic mitral valve of claim 9, wherein the atrial skirt further comprises a plurality of barbs coupled thereto, the plurality of barbs adapted to anchor the atrial skirt into a superior surface of the patient'"'"'s native mitral valve.

12. The prosthetic mitral valve of claim 1, wherein the anchor further comprises an annular region configured to expand radially outward so as to conform with and engage an annulus of the native mitral valve when the anchor is in the expanded configuration and configured to be anchored to the native mitral valve.

13. The prosthetic mitral valve of claim 12, wherein the annular region expands asymmetrically such that an anterior portion of the annular region is substantially flat and a posterior portion of the annular region is cylindrically shaped, thus avoiding or minimizing impinging on the left ventricular outflow tract (LVOT).

14. The prosthetic mitral valve of claim 1, wherein the ventricular skirt expands asymmetrically such that an anterior portion of the ventricular skirt is substantially flat and a posterior portion of the ventricular skirt is cylindrically shaped, thus avoiding or minimizing impinging on the left ventricular outflow tract (LVOT).

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

16. The prosthetic mitral valve of claim 1, wherein at least a portion of the anchor is configured to self-expand when unconstrained.

17. The prosthetic mitral valve of claim 1, wherein at least a portion of the anchor comprises one or more radiopaque markers.

18. The prosthetic mitral valve of claim 1, wherein at least a portion of the anchor comprises a therapeutic agent coupled thereto, wherein the therapeutic agent is adapted to be eluted therefrom.

19. The prosthetic mitral valve of claim 1, wherein at least a portion of the anchor 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.

20. The prosthetic mitral valve of claim 19, wherein one or more of the axially oriented struts comprise one or more suture holes extending therethrough, the suture holes sized to receive a suture.

21. The prosthetic mitral valve of claim 1, wherein, when the anchor is anchored in the native mitral valve in the expanded configuration, the anchor is configured to displace native mitral valve leaflets radially outward.

22. A prosthetic mitral valve for anchoring in a patient'"'"'s heart having a native mitral valve, said prosthetic mitral valve comprising:

a plurality of prosthetic valve leaflets, each of the leaflets having a fixed end and a free end opposite of the fixed end, wherein the prosthetic mitral valve, when anchored in the mitral 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; and

an anchor coupled to the plurality of prosthetic valve leaflets at the fixed ends, the anchor having a collapsed configuration for delivery to the heart and an expanded configuration for anchoring the prosthetic mitral valve to the native mitral valve, wherein the anchor comprises;

an atrial skirt configured to expand radially outward so as to lie over a superior surface of the patient'"'"'s native mitral valve and anchor against a portion of an atrium of the patient'"'"'s heart when the anchor is anchored in the native mitral valve in the expanded configuration;

an annular region configured to expand radially outward so as to conform with an annulus of the native mitral valve when in the expanded configuration and configured to be anchored to the native mitral valve; and

a ventricular skirt comprising first and second trigonal anchoring tabs disposed on an anterior portion of the ventricular skirt, the first and second trigonal anchoring tabs extending radially outward and facing toward the atrium when the anchor is in the expanded configuration, and wherein the first and second trigonal anchoring tabs are configured to respectively engage first and second fibrous trigones on first and second sides, respectively, of an anterior leaflet of the patient'"'"'s native mitral valve such that a first portion of the anterior leaflet is disposed between the first trigonal anchoring tab and a first part of an anterior surface of the ventricular skirt and a second portion of the anterior leaflet is disposed between the second trigonal anchoring tab and a second part of the anterior surface of the ventricular skirt when the anchor in the expanded configuration and anchored to the native mitral valve, and

wherein adjacent chordae tendineae are disposed between one or more of the first trigonal anchoring tab or the second trigonal anchoring tab of the ventricular skirt and the anterior surface of the ventricular skirt when then anchor is in the expanded configuration and anchored to the native mitral valve, and

wherein the ventricular skirt further comprises a posterior anchoring tab disposed on a posterior portion of the ventricular skirt extending radially outward to engage a posterior portion of the native mitral valve, wherein a posterior leaflet of the native mitral valve is disposed between the posterior anchoring tab and an outer posterior surface of the ventricular skirt or the anchor when the anchor is in the expanded configuration and anchored in the native mitral valve, and

wherein one or more of the atrial skirt, the annular region, and the ventricular skirt have an asymmetrically shaped D-shaped cross-section with a substantially flat anterior portion and a cylindrically shaped posterior portion to conform with a shape of the mitral valve and surrounding anatomy, thus avoiding or minimizing left ventricular outflow tract (LVOT) impingement when the anchor is anchored in the native mitral valve in the expanded configuration.

23. The prosthetic mitral valve of claim 22, wherein one or more of the atrial skirt, annular region, and ventricular skirt of the anchor is covered with tissue or a synthetic material.

24. The prosthetic mitral valve of claim 22, wherein at least a portion of one or more of the prosthetic valve leaflets comprises tissue or a synthetic material.

25. The prosthetic mitral valve of claim 22, wherein one or more of the atrial skirt, annular region, or ventricular skirt of the anchor is configured to expand asymmetrically.

26. The prosthetic mitral valve of claim 22, wherein one or more of the atrial skirt, annular region, or ventricular skirt of the anchor is configured to self-expand when unconstrained.

27. The prosthetic mitral valve of claim 22, wherein one or more of the anchor or the plurality of prosthetic valve leaflets comprises a therapeutic agent coupled thereto, wherein the therapeutic agent is adapted to be eluted therefrom.