Heart valve prosthesis with collapsible valve and method of delivery thereof

• US 9,078,751 B2
• Filed: 03/17/2010
• Issued: 07/14/2015
• Est. Priority Date: 03/17/2009
• Status: Active Grant

• Current Assignee: MitrAssist Medical Ltd.
• Original Assignee: MitrAssist Medical Ltd.
• Inventors: Naor, Gil
• Primary Examiner(s): Snow, Bruce E
• Assistant Examiner(s): DUKERT, BRIAN AINSLEY
• Application Number:
  US12/726,338
• Publication Number:
  US 20100280606A1
• Time in Patent Office: 1,945 Days
• Field of Search: 623 212- 219, 623 236- 237, 623/2.1
• US Class Current: 1/1
• 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 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2448 D-shaped rings
• CPC Class Codes: A61F 2/2454 Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2/2496 Devices for determining the dimensions of the prosthetic valve to be implanted, e.g. templates, sizers
• 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

Abstract

A valve prosthesis is adapted to operate in conjunction with native heart valve leaflets. The prosthesis includes an annulus and a skirt extending from the annulus. The skirt may be configured to be positioned through a native heart valve annulus, and the skirt may be movable between an open configuration permitting blood flow through the skirt and a closed configuration blocking blood flow through the skirt in cooperation with opening and closing of the native heart valve leaflets.

Claims

1. A valve prosthesis comprising:

a frame element configured for positioning at or near a native heart valve annulus, over native heart valve leaflets, shaped to prevent the frame element from shifting downstream of the native heart annulus;

a skirt attached to said frame element, the skirt being configured to be positioned through the native heart valve, the skirt being movable between an open configuration permitting blood flow through the skirt and a closed configuration blocking blood flow through the skirt in cooperation with opening and closing of the native heart valve leaflets; and

at least two skirt support extensions attached to the frame, all the skirt support extensions configured and circumferentially arranged to extend through the skirt at ends of commissures of the native heart valve between the native heart valve leaflets, where the native heart valve leaflets meet, while preserving the function of the opening and closing of the native heart valve leaflets, and prevent the skirt from collapsing back from a downstream direction to an upstream direction.

2. The valve prosthesis of claim 1, wherein a part of said frame element is a D-shaped annulus element conforming to a shape of a mitral valve annulus.

3. The valve prosthesis of claim 1, further comprising one or more elements for anchoring said frame to tissue.

4. The valve prosthesis of claim 1, wherein said frame comprises a plurality of additional extensions extending from said frame element.

5. The valve prosthesis of claim 4, wherein at least one of said additional extensions includes a hook adapted for hooking into a ventricle wall.

6. The valve prosthesis of claim 4, wherein at least one of said additional extensions includes an eyelet.

7. The valve prosthesis of claim 4, wherein said additional extensions are configured for supporting said skirt.

8. The valve prosthesis of claim 4, wherein said additional extensions are shaped and positioned for passing through the commissures of said native heart valve, between the native heart valve leaflets.

9. The valve prosthesis of claim 1, wherein said frame element is a stent which is adapted to expand radially to apply an anchoring force to a wall of an atrium.

10. The valve prosthesis of claim 1, wherein said skirt includes a first skirt portion capable of coapting to a second skirt portion along a curve.

11. The valve prosthesis of claim 10, wherein said first skirt portion and said second skirt portion form a funnel having an off-center opening capable of closing to form said curve.

12. The valve prosthesis of claim 11, wherein said open funnel is configured to close when said leaflets of said native heart valve naturally close.

13. The valve prosthesis of claim 1, and further comprising at least two commissure anchoring extensions, each one of the commissure anchoring extensions located at a location of ends of commissures of the native heart valve, configured to extend between the native heart valve leaflets through the commissures, preventing the commissure anchoring extensions from shifting back from a downstream side of the native heart annulus to the upstream side of the native heart annulus.

14. The valve prosthesis of claim 1, and further comprising at least one extension to the frame configured to extend downwardly along the skirt and hook back for anchoring the valve prosthesis.

15. The valve prosthesis of claim 1, in which a first skirt support extension which extends through the skirt to prevent the skirt from collapsing is connected at a downstream tip to a second skirt support extension which extends through the skirt to prevent the skirt from collapsing.

16. The valve prosthesis of claim 13 in which location of the at least two commissure anchoring extensions corresponds to locations of ends of commissures of a mitral valve.

17. The valve prosthesis of claim 13 in which location of the at least two commissure anchoring extensions corresponds to locations of ends of commissures of a tricuspid valve.

18. A method of delivering a heart valve prosthesis to a heart valve, the method comprising:

delivering a prosthesis as recited in claim 1 to a heart; and

deploying the prosthesis such that the prosthesis can work in cooperation with the native heart valve.