HEART VALVE

• US 20160331531A1
• Filed: 07/25/2016
• Published: 11/17/2016
• Est. Priority Date: 09/29/2008
• Status: Active Grant

• Current Assignee: Edwards Lifesciences CardiAQ LLC (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences CardiAQ LLC (Edwards Lifesciences Corporation)
• Inventors: Quadri, Arshad, Ratz, J. Brent
• Granted Patent: US 10,149,756 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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 prosthesis configured to be deployed within a native valve, the prosthesis comprising:

an expandable frame comprising a proximal end, a distal end and a longitudinal axis extending between the proximal and distal ends, the frame comprising a foreshortening portion having a plurality of foreshortening cells, the frame configured to radially expand and collapse for deployment within the native valve;

a number of proximal anchors each connected to the frame and having free ends positioned radially outward from the frame when the frame is in an expanded configuration, wherein each of the plurality of proximal anchors comprises first and second struts connected to and extending radially outward from the frame when the frame is in an expanded configuration;

a number of distal anchors equal to the number of proximal anchors, the distal anchors each connected to the frame and having free ends positioned radially outward from the frame and extending toward the proximal end when the frame is in an expanded configuration;

a valve body attached to the frame, wherein the valve body can move between (i) an open position wherein blood can flow from the proximal end toward the distal end; and

(ii) a closed position which blocks blood from flowing from the distal end toward the proximal end;

wherein the frame is configured such that radial expansion of the frame causes the free ends of the proximal and distal anchors to draw closer together; and

wherein the prosthesis is configured such that, after the prosthesis has been delivered to the native valve and expanded, the proximal anchors are positioned on an inflow side of the native valve and the distal anchors are positioned on an outflow side of the native valve.

2. The prosthesis of claim 1, wherein when the frame is in an expanded configuration, the free ends of the proximal anchors are equally spaced around an entire circumference of the frame.

3. The prosthesis of claim 2, wherein when the frame is in the expanded configuration, the free ends of the distal anchors are equally spaced around the entire circumference of the frame.

4. The prosthesis of claim 3, wherein the free ends of the proximal anchors and the distal anchors are circumferentially offset when the frame is in an expanded configuration.

5. The prosthesis of claim 1, wherein a distance between the first and second struts where the first and second struts connect to the frame is greater than a distance between the first and second struts near the free end of each proximal anchor.

6. The prosthesis of claim 5, wherein the first and second struts form a V-shape.

7. The prosthesis of claim 1, wherein the foreshortening portion comprises a row of foreshortening cells and wherein the number of proximal anchors and the number of distal anchors is the same as the number of foreshortening cells in the row.

8. The prosthesis of claim 1, wherein each of the distal anchors is connected to a distal portion of a foreshortening cell.

9. The prosthesis of claim 8, wherein each of the distal anchors is connected to a distal apex of a foreshortening cell.

10. The prosthesis of claim 1, wherein the first and second struts are each connected to the frame at a connection point and wherein a distance between the connection points of the first and second struts is approximately equal to a distance between two lateral sides of at least one of the foreshortening cells.

11. The prosthesis of claim 1, wherein each of the distal anchors comprises a straight segment.

12. The prosthesis of claim 1, further comprising a skirt extending over at least one of the plurality of proximal anchors and the plurality of distal anchors.

13. The prosthesis of claim 1, comprising at least nine proximal anchors and at least nine distal anchors.

14. The prosthesis of claim 1, comprising twelve proximal anchors and twelve distal anchors.

15. A prosthesis configured to be deployed within a patient'"'"'s mitral valve having a mitral annulus, the prosthesis comprising:

an expandable frame comprising a proximal end, a distal end, and a longitudinal axis extending between the proximal and distal ends, the frame configured to radially expand and collapse for deployment within the mitral valve, the frame comprising a foreshortening section having a row of foreshortening cells near the distal end of the frame;

a number of distal anchors each having a base connected to a distal portion of a foreshortening cell, the distal anchors each having free ends positioned radially outward from the frame and extending toward the proximal end when the frame is in an expanded configuration so that the free ends of the distal anchors are closer to the proximal end than the bases are to the proximal end; and

a number of equally spaced proximal anchors proximal to the distal anchors and positioned around an entire circumference of the frame, each proximal anchor having a free end which is positioned radially outward from the frame when the frame is in an expanded configuration;

a valve body attached to the frame, wherein the valve body can move between (i) an open position wherein blood can flow from the proximal end toward the distal end to allow blood to flow from the left atrium to the left ventricle; and

(ii) a closed position which blocks blood from flowing from the distal end toward the proximal end to block blood from flowing from the left ventricle to the left atrium;

wherein the free ends of the proximal anchors and the free ends of the distal anchors are circumferentially offset when the frame is in an expanded configuration;

wherein the prosthesis is configured such that, after the prosthesis has been delivered to the mitral valve and expanded, the proximal anchors are on an atrial side of the mitral annulus and the distal anchors are on a ventricular side of the mitral annulus; and

wherein the frame is configured such that radial expansion of the frame causes the free ends of the proximal anchors and the free ends of the distal anchors to draw closer together.

16. The prosthesis of claim 15, wherein each of the proximal anchors comprises first and second struts and a distance between the first and second struts decreases towards the free end of the proximal anchor.

17. The prosthesis of claim 16, wherein the first and second struts are each connected to the frame at a connection point and wherein a distance between the connection points of the first and second struts is approximately equal to a distance between two lateral sides of at least one of the foreshortening cell.

18. The prosthesis of claim 17, wherein the first and second struts form a V-shape.

19. The prosthesis of claim 15, wherein the number of distal anchors is the same as the number of foreshortening cells in the row.

20. The prosthesis of claim 15, wherein the number of proximal anchors is the same as the number of foreshortening cells in the row.

21. The prosthesis of claim 15, wherein each of the distal anchors comprises a straight segment.

22. The prosthesis of claim 15, wherein the prosthesis has the same number of the proximal and distal anchors.

23. The prosthesis of claim 15, further comprising a skirt extending over at least one of the plurality of proximal anchors and the plurality of distal anchors.

24. The prosthesis of claim 15, comprising at least nine proximal anchors and at least nine distal anchors.

25. The prosthesis of claim 15, comprising twelve proximal anchors and twelve distal anchors.