Replacement heart valve and method

• US 8,894,702 B2
• Filed: 01/22/2013
• Issued: 11/25/2014
• Est. Priority Date: 09/29/2008
• Status: Active Grant

• Current Assignee: Edwards Lifesciences CardiAQ LLC (Edwards Lifesciences Corporation)
• Original Assignee: Cardiaq Valve Technologies Incorporated
• Inventors: Quadri, Arshad, Ratz, J. Brent
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): Mathew, Seema
• Application Number:
  US13/747,384
• Publication Number:
  US 20130131793A1
• Time in Patent Office: 672 Days
• Field of Search: 623/1.24, 623/2.17, 623/1.31, 623/1.36, 623/2.1, 623/2.14, 623/2.23
• US Class Current: 623/1.36
• CPC Class Codes: A61F 2/2403 with pivoting rigid closure members check valves with hinged closure members in general F16K15/03
• 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 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• CPC Class Codes: A61F 2002/8483 Barbs
• CPC Class Codes: A61F 2002/8486 provided on at least one of the ends
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/005 using adhesives
• 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 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: Y10T 29/49426 including metal shaping and diverse operation

Abstract

A method of treating a native heart valve includes delivering a replacement valve to the native heart valve. The native heart valve can be any one of aortic, pulmonary, mitral and tricuspid valves. The replacement valve comprising an expandable frame and a valve body attached to the expandable frame. The method can also include expanding the frame at a patient'"'"'s valve annulus, wherein expansion of the frame causes respective ends of both proximal anchors and distal anchors connected to the frame to draw closer together to grasp native tissue between the respective ends of the proximal anchors and distal anchors.

Claims

1. A method for treating mitral valve insufficiency of a patient, comprising:

delivering a replacement heart valve into the patient, the replacement heart valve comprising;

an expandable frame extending along a longitudinal axis between a proximal end and a distal end, the frame comprising a plurality of foreshortening cells having a proximal end and a distal end and a plurality of struts having at least a portion thereof extending longitudinally, the struts having distal ends that are connected to proximal ends of foreshortening cells; and

a valve body attached to the expandable frame;

expanding the frame at a patient'"'"'s mitral valve annulus, wherein when the frame is in an expanded configuration;

a plurality of circumferentially spaced proximal anchors connected to the struts extend radially outward from the frame on a left atrial side of the native mitral valve annulus; and

a plurality of circumferentially spaced distal anchors connected to the foreshortening cells are positioned on a left ventricular side of the native valve annulus, wherein the distal anchors extend longitudinally in a proximal direction generally toward the native mitral valve annulus to proximalmost portions of the distal anchors that are spaced radially outward from an outer surface of the frame.

2. The method of claim 1, wherein when the frame is in an expanded configuration, the proximal anchors extend distally toward a left atrial side of the native mitral valve annulus.

3. The method of claim 2, wherein when the frame is in an expanded configuration, distalmost portions of the proximal anchors are circumferentially offset from the proximal portions of the distal anchors.

4. The method of claim 1, wherein when the frame is in an expanded configuration, each of the proximal anchors comprises at least a first strut and a second strut extending radially outwardly from the frame and joined at an apex to form a V-shaped anchor.

5. The method of claim 1, further comprising engaging the proximal anchors with the left atrial side of the native mitral valve annulus.

6. The method of claim 1, wherein when the frame is in an expanded configuration, the distal anchors extend from distal ends of foreshortening cells and bend radially outward before turning in a direction that extends longitudinally in a proximal direction.

7. The method of claim 1, comprising engaging a left ventricular side of the native mitral valve annulus with proximalmost portions of the distal anchors.

8. The method of claim 1, wherein the frame comprises a foreshortening portion comprising the plurality of foreshortening cells and a non-foreshortening portion comprising the plurality of struts, wherein the foreshortening portion is located in a distal portion of the frame and the non-foreshortening portion is located proximal to the foreshortening porton, and wherein the non-foreshortening portion is not substantially expandable in a longitudinal direction.

9. The method of claim 8, wherein when the frame is in an expanded configuration, the native mitral valve annulus is positioned alongside the foreshortening portion of the frame.

10. The method of claim 1, wherein the proximal anchors are connected to the distal ends of the struts.

11. The method of claim 1, wherein the proximal anchors are connected to the struts at locations spaced proximally from the distal ends of the struts.