REPLACEMENT HEART VALVE AND METHOD

• US 20130131793A1
• Filed: 01/22/2013
• Published: 05/23/2013
• 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
• Granted Patent: US 8,894,702 B2
• Time in Patent Office: Days
• US Class Current: 623/2.38
• 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 heart valve includes a valve body made of a flexible material such as pericardium. The valve body is made of two layers of material, an outer layer, and an inner layer that defines a plurality of leaflets. The leaflets of the inner layer are attached to the outer layer. In some embodiments the valve body is made by cutting a single piece of flat source tissue, folding the cut tissue and forming it into a tubular pattern having the inner and outer layers. The multi-layer valve body can be mounted on a stent for delivery within a patient'"'"'s heart.

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 and a valve body attached to the expandable frame; and

expanding the frame at a patient'"'"'s mitral 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.

2. The method of claim 1, wherein after expansion of the frame, the proximal anchors and distal anchors are not generally collinearly aligned.

3. The method of claim 1, wherein expanding the frame comprises foreshortening at least a portion of the frame.

4. The method of claim 1, wherein expanding the frame comprises foreshortening a distal portion of the frame.

5. The method of claim 4, wherein the proximal and distal anchors grasp native tissue along the distal portion of the frame.

6. The method of claim 1, wherein the frame comprises a foreshortening portion and a non-foreshortening portion, wherein expanding the frame further comprises foreshortening the foreshortening portion while the non-foreshortening portion does not foreshorten.

7. The method of claim 6, wherein the foreshortening portion is located in a distal portion of the frame, and the non-foreshortening portion is located at least in a proximal portion of the frame.

8. The method of claim 7, wherein after expanding the frame at a patient'"'"'s mitral valve annulus, a proximal portion of the frame is positioned at least partially in the patient'"'"'s atrium.

9. The method of claim 1, wherein when the frame is in an expanded configuration, the proximal anchors have ends positioned radially outward from the frame and extending distally, and the distal anchors have ends positioned radially outward from the frame and extending proximally.

10. The method of claim 9, wherein when the frame is in an expanded configuration, the ends of the proximal anchors extend distally in an axial direction generally parallel with a longitudinal axis of the frame, and the ends of the distal anchors extend proximally in an axial direction generally parallel with the longitudinal axis of the frame

11. The method of claim 1, wherein expanding the frame comprises expanding the frame by self-expansion.