Method for implanting a prosthetic mitral valve

• US 8,986,373 B2
• Filed: 09/12/2013
• Issued: 03/24/2015
• 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, Hauser, David L.
• Primary Examiner(s): STEWART, JASON-DENNIS NEILKEN
• Application Number:
  US14/025,701
• Publication Number:
  US 20140012373A1
• Time in Patent Office: 558 Days
• Field of Search: 623/1.24, 623/1.26, 623 21- 219, 606/108
• US Class Current: 623/2.17
• 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

Embodiments of a method for implanting a prosthetic valve at the native mitral valve region of the heart, the prosthetic valve including a main body that is radially compressible to a radially compressed state and self-expandable from the compressed state to a radially expanded state. The prosthetic apparatus also comprises at least one ventricular anchor coupled to the main body and disposed outside of the main body with a leaflet-receiving space between the anchor and an outer surface of the main body to receive a native valve leaflet. Apparatus for delivering and implanting the prosthetic valve are also described.

Claims

1. A method of implanting a prosthetic heart valve at the native mitral valve region of a heart, the native mitral valve having a native mitral valve orifice and native mitral valve leaflets, the method comprising:

positioning a docking frame within the native mitral valve orifice such that the docking frame is secured to the native mitral valve leaflets, wherein positioning the docking frame within the native mitral valve orifice comprises positioning a first ventricular anchor behind the anterior native mitral valve leaflet and positioning a second ventricular anchor behind the posterior native mitral valve leaflet; and

then

securing a prosthetic valve within the docking frame.

2. The method of claim 1, wherein positioning the docking frame within the native mitral valve orifice comprises delivering the docking frame into the mitral valve orifice in a radially compressed state and allowing the docking frame to self-expand to a radially expanded state contacting inner surfaces of the native mitral valve leaflets.

3. The method of claim 1, wherein the docking frame comprises an annular main body that comprises a lumen for receiving the prosthetic valve.

4. The method of claim 1, wherein the anterior native mitral valve leaflet is compressed between the first ventricular anchor and an outer surface of a main body of the docking frame, and the posterior native mitral valve leaflet is compressed between the second ventricular anchor and an outer surface of the main body of the docking frame.

5. The method of claim 1, wherein securing a prosthetic valve within the docking frame comprises delivering the prosthetic valve in a radially compressed state into a lumen formed within the docking frame, and allowing the prosthetic valve to self-expand to a radially expanded state contacting inner surfaces of the docking frame.

6. The method of claim 1, wherein securing a prosthetic valve within the docking frame comprises delivering the prosthetic valve in a radially compressed state into a lumen formed within the docking frame, and causing the prosthetic valve to expand to a radially expanded state contacting inner surfaces of the docking frame.

7. The method of claim 1, wherein the prosthetic valve comprises a radially compressible and expandable frame configured to engage with the inside of the docking frame.

8. The method of claim 1, wherein the prosthetic valve is secured within the docking frame via friction.

9. The method of claim 1, wherein the prosthetic valve is secured within the docking frame via a mechanical locking feature.

10. The method of claim 1, wherein the prosthetic valve comprises an atrial anchor that is positioned within the left atrium so as to engage an atrial surface of the native mitral valve when the prosthetic valve is secured within the docking frame.

11. A method of implanting a prosthetic heart valve at the native mitral valve region of a heart, the native mitral valve having a native mitral valve orifice and native mitral valve leaflets, the method comprising:

implanting a radially expandable docking frame within the native mitral valve orifice, the docking frame comprising an annular body defining an inner lumen and ventricular anchors positioned behind the native mitral valve leaflets; and

then

securing a radially expandable prosthetic valve within the docking frame.

12. The method of claim 11, wherein implanting the docking frame within the native mitral valve orifice comprises delivering the docking frame into the mitral valve orifice in a radially compressed state and allowing the docking frame to self-expand to a radially expanded state contacting inner surfaces of the native mitral valve leaflets.

13. The method of claim 11, wherein implanting the docking frame within the native mitral valve orifice comprises positioning a first ventricular anchor behind the anterior native mitral valve leaflet and positioning a second ventricular anchor behind the posterior native mitral valve leaflet.

14. The method of claim 11, wherein securing a prosthetic valve within the docking frame comprises delivering the prosthetic valve in a radially compressed state into the inner lumen of the annular body of the docking frame, and allowing the prosthetic valve to self-expand to a radially expanded state contacting inner surfaces of the annular body of the docking frame.

15. The method of claim 11, wherein the prosthetic valve comprises a radially compressible and expandable frame configured to engage with the annular body of the docking frame.