Percutaneous heart valve prosthesis

• US 10,213,298 B2
• Filed: 02/16/2015
• Issued: 02/26/2019
• Est. Priority Date: 03/11/2004
• Status: Active Grant

• Current Assignee: Percutaneous Cardiovascular Solutions Pty Limited (Edwards Lifesciences Corporation)
• Original Assignee: Percutaneous Cardiovascular Solutions Pty Limited (Edwards Lifesciences Corporation)
• Inventors: Thambar, Suku, Jayasinghe, Stayajit Rohan
• Primary Examiner(s): Bui, Vy
• Application Number:
  US14/623,301
• Publication Number:
  US 20150157458A1
• Time in Patent Office: 1,471 Days
• Field of Search: 623 111, 623 124, 623 126, 623 211, 623 214, 623 215, 623 217, 623 219, 606191, 606192, 606194, 606195
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• 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 2/2487 Devices within the heart chamber, e.g. splints
• CPC Class Codes: A61F 2002/8486 provided on at least one of the ends
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• 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 2230/0067 conical

Abstract

A percutaneous heart valve prosthesis (1) has a valve body (2) with a passage (9) extending between the first and second ends (7, 8) of the valve body (2). The valve body (2) is collapsible about a longitudinal axis (10) of the passage (9) for delivery of the valve body (2) via a catheter (18). One or more flexible valve leaflets (3, 4) are secured to the valve body (2) and extend across the passage (9) for blocking bloodflow in one direction through the passage (9). An anchor device (5), which is also collapsible for delivery via catheter (18), is secured to the valve body (2) by way of an anchor line (6). A failed or failing mitral heart valve (101) is treated by percutaneously locating the valve body (2) in the mitral valve orifice (102) with the anchor device (5) located in the right atrium (107) and engaging the inter-atrial septum (103), such that the taught anchor line (6) acts to secure the valve body (2) within the mitral valve orifice (102).

Claims

1. A percutaneous mitral valve prosthesis, comprising:

a valve body having a valve body inlet end, a valve body outlet end and a passage extending along a longitudinal axis between said valve body inlet end and said valve body outlet end, said valve body being collapsible about said longitudinal axis for delivery via a catheter;

a plurality of flexible valve leaflets made from pericardial material, the valve leaflets secured to said valve body and extending across said passage such that valve leaflets collapse toward each other for blocking a blood flow in one direction through said passage from said valve body outlet end to said valve body inlet end;

a flexible skirt extending about a periphery of said valve body, said flexible skirt adapted for blocking the blood flow in said one direction between said valve body and the native wall of a mitral valve orifice; and

a plurality of prongs secured to said outlet end of said valve body and extending toward said inlet end of said body;

wherein said valve body tapers toward said valve body inlet end such that a diameter of the valve body inlet end is smaller than a diameter of the valve body outlet end;

wherein said valve body comprises a valve body frame comprising a plurality of valve body frame elements arranged to form a plurality of circumferentially extending rows of cells, wherein one row of cells comprises a plurality acute-angled vertices at said valve body inlet end and another row of cells comprises a plurality of acute-angled vertices at said valve body outlet end.

2. The prosthesis of claim 1 wherein said flexible skirt is formed of biological material.

3. The prosthesis of claim 1 wherein said flexible skirt is formed of Dacron.

4. The prosthesis of claim 1 wherein said valve body frame elements are elastic.

5. The prosthesis of claim 4 wherein said valve body frame comprises at least three valve body sub-frame members, each said valve body sub-frame member having the general form of a deltoid and forming a respective cell in said one row of cells and a respective cell in said another row of cells.

6. The prosthesis of claim 5 wherein each of said valve body sub-frame members has the general form of a rhombus.

7. The prosthesis of claim 5 wherein adjacent said valve body sub-frame members are joined at respective oblique-angled vertices located between the valve body inlet end and the valve body outlet end.

8. The prosthesis of claim 7 wherein each said sub-frame member further comprises a collapsible diagonal element extending between said oblique-angled vertices.

9. The prosthesis of claim 8 wherein said one or more valve leaflets is/are secured to said diagonal elements.

10. The prosthesis of claim 8 wherein said flexible skirt is secured to said diagonal elements.

11. the prosthesis of claim 1, wherein said prongs extend from the plurality acute-angled vertices at said valve body inlet end.

12. The prosthesis of claim 1, wherein said flexible skirt is positioned on said valve body to receive retrograde blood in the left ventricle during ventricular systole when the prosthesis is implanted within a native mitral valve.

13. The prosthesis of claim 12, wherein said valve leaflets and said flexible skirt are sutured to the same valve body frame elements.

14. The prosthesis of claim 1, wherein said flexible skirt is sutured to the valve body frame elements.

15. A percutaneous mitral valve prosthesis, comprising:

a collapsible and expandable valve body made from a shape memory material, the valve body having a first, inlet end, a second, outlet end and a passage extending along a longitudinal axis between said inlet end and said outlet end, said valve body being tapered toward said valve body inlet end, said valve body being collapsible about said longitudinal axis for delivery via a catheter;

three flexible valve leaflets made from pericardial material, the valve leaflets secured to said valve body and extending across said passage such that the valve leaflet leaflets collapse toward each other for blocking a blood flow in one direction through said passage from said valve body outlet end to said valve body inlet end;

a flexible skirt extending about a periphery of said valve body, said flexible skirt adapted for blocking the blood flow in said one direction between an exterior of said valve body and a mitral valve orifice, wherein said flexible skirt is positioned on said valve body to receive retrograde blood in the left ventricle during ventricular systole when the prosthesis is implanted within a native mitral valve; and

a plurality of prongs extending from said outlet end of said valve body and pointing toward said inlet end of said body.

16. The prosthesis of claim 15, further comprising an anchor line extending from said first end of said valve body, wherein said anchor line comprises a polymeric material.

17. The prosthesis of claim 16, further comprising an anchor device secured to said anchor line.

18. The prosthesis of claim 17, wherein said anchor device is collapsible.

19. The prosthesis of claim 15, wherein said valve body is sized for advancement through a femoral vein while in a collapsed configuration.

20. The prosthesis of claim 15, wherein said flexible skirt is formed of Dacron.

21. The prosthesis of claim 20, wherein said flexible skirt extends further radially outwardly than said valve body.

22. The prosthesis of claim 21, wherein said valve body comprises a valve body frame comprising a plurality of angled frame elements arranged in zig-zag rows of angled frame elements and a first end of said flexible skirt is sutured to said frame elements of one of said zig-zag rows.

23. The prosthesis of claim 22, wherein at least a portion of a second end of said flexible skirt is not attached to said valve body, thereby providing a clearance between said exterior of said valve body and said second end of said flexible skirt.

24. The prosthesis of claim 23, wherein said valve leaflets are sutured to frame elements in the same row of angled frame elements as said first end of said flexible skirt.