Prosthetic valve for replacing mitral valve

• US 9,717,591 B2
• Filed: 08/03/2016
• Issued: 08/01/2017
• Est. Priority Date: 12/04/2009
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Chau, Mark, Patterson, Marlowe E., Yi, Seung-Beom, Geist, Stephen C., Oba, Travis Zenyo
• Primary Examiner(s): STEWART, JASON-DENNIS NEILKEN
• Application Number:
  US15/227,238
• Publication Number:
  US 20160338826A1
• Time in Patent Office: 363 Days
• 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 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• 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 2230/0069 cylindrical
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2250/0063 Nested prosthetic parts

Abstract

A prosthetic apparatus for implantation in a native mitral valve includes a main body for placement within the native mitral annulus. The main body is compressible to a radially compressed state for delivery into the heart and is self-expandable from the compressed state to a radially expanded state for implantation. A valve structure is mounted within a lumen of the main body and preferably forms three leaflets made of pericardium. An atrial sealing member is disposed along an atrial portion of the main body and ventricular anchors are coupled to a ventricular portion of the main body. The atrial sealing member impedes the flow of blood between the main body and the native annulus. The ventricular anchors are positioned outside the main body for capturing native mitral valve leaflets between the main body and the ventricular anchors.

Claims

1. A prosthetic apparatus for implantation at the native mitral valve region of the heart, the native mitral valve having a native annulus, a native anterior leaflet, and a native posterior leaflet, the prosthetic apparatus comprising:

a main body comprising a lumen and configured for placement within the native annulus, the main body being radially compressible to a radially compressed state for delivery into the heart and self-expandable from the compressed state to a radially expanded state;

a valve structure comprising three leaflets made from pericardium, the valve structure mounted within the lumen of the main body;

an atrial sealing member disposed along an atrial portion of the main body; and

a plurality of ventricular anchors coupled to a ventricular portion of the main body and positioned outside the lumen of the main body, wherein a leaflet-receiving space is provided between each of the ventricular anchors and an outer surface of the main body.

2. The prosthetic apparatus of claim 1, wherein the atrial sealing member extends radially outwardly from the main body for contacting an atrial side of a mitral annulus and preventing blood from flowing between the main body and the mitral annulus when the prosthetic apparatus is implanted.

3. The prosthetic apparatus of claim 2, further comprising a sealing layer disposed along a surface of the atrial sealing member, wherein the sealing layer is impervious to the flow of blood.

4. The prosthetic apparatus of claim 3, wherein the sealing layer is made from a polyester material.

5. The prosthetic apparatus of claim 1, wherein the plurality of ventricular anchors comprises a single posterior anchor for capturing the native posterior leaflet.

6. The prosthetic apparatus of claim 5, wherein the single posterior anchor is configured to capture an intermediate portion of the native posterior leaflet between a postero-medial margin of the native posterior leaflet and an antero-lateral margin of the native posterior leaflet.

7. The prosthetic apparatus of claim 5, wherein the plurality of ventricular anchors further comprises an anterior anchor for capturing the native anterior leaflet of the native mitral valve.

8. The prosthetic apparatus of claim 1, wherein the main body is made of a wire mesh.

9. The prosthetic apparatus of claim 1, wherein the main body further comprises atrial and ventricular ends having zig-zag patterns.

10. The prosthetic apparatus of claim 1, wherein each of the plurality of ventricular anchors comprises a U-shape that is connected to the main body at two attachment locations.

11. A prosthetic apparatus for implantation at the native mitral valve region of the heart, the native mitral valve having a native annulus and native valve leaflets, the leaflets comprising a free edge portion and an annulus connection portion, the prosthetic apparatus comprising:

a main body configured for placement within the native mitral valve, the main body being compressible to a compressed state for delivery into the heart and expandable from the compressed state to an expanded state;

at least one ventricular anchor coupled to and disposed outside the main body such that, in the expanded state, a leaflet-receiving space exists between the ventricular anchor and an outer surface of the main body to receive a free edge portion of a native valve leaflet, the ventricular anchor comprising an engagement portion configured to extend behind the received native leaflet and engage a ventricular surface of the native mitral annulus, the annulus connection portion of the received native leaflet, or both the ventricular surface of the native annulus and the annulus connection portion of the received native leaflet; and

at least one atrial anchor coupled to and disposed outside the main body, the at least one atrial anchor being configured to engage an atrial portion of the native mitral annulus, the annulus connection portion of the received native leaflet, or both the atrial surface of the native annulus and the annulus connection portion of the received native leaflet, at a location opposite the engagement portion of the ventricular anchor for retention of the prosthetic apparatus.

12. The prosthetic apparatus of claim 11, wherein the at least one ventricular anchor is configured such that the free edge portion of the received native leaflet is not engaged by the ventricular anchor after implantation of the prosthetic apparatus.

13. The prosthetic apparatus of claim 11, wherein the at least one atrial anchor extends radially outwardly from the main body for contacting an atrial side of the native mitral annulus and preventing blood from flowing between the main body and the native mitral annulus when the prosthetic apparatus is implanted.

14. The prosthetic apparatus of claim 13, wherein the at least one atrial anchor further comprises a sealing layer disposed along a surface of the at least one atrial anchor.

15. The prosthetic apparatus of claim 14, wherein the sealing layer is impervious to the flow of blood.

16. The prosthetic apparatus of claim 15, wherein the sealing layer is made from a polyester material.

17. The prosthetic apparatus of claim 11, wherein the main body is made of a wire mesh.

18. The prosthetic apparatus of claim 11, wherein the main body further comprises atrial and ventricular ends having zig-zag patterns.