Heart valve

• US 8,403,983 B2
• Filed: 09/29/2009
• Issued: 03/26/2013
• 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
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): Mathew, Seema
• Application Number:
  US12/569,856
• Publication Number:
  US 20100082094A1
• Time in Patent Office: 1,274 Days
• Field of Search: 623/1.24, 623/2.12, 623/1.26, 623/2.14, 623/2.17
• US Class Current: 623/2.17
• 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 replacement heart valve can comprise a valve body and an elongate frame. The valve body can define a plurality of leaflets adapted to move between an open state and a coapted state. The elongate frame can be configured to move between a radially compacted state and a radially expanded state, the frame comprising a plurality of struts. Stitches attach the valve body to the plurality of struts. At least one of the stitches can be a loose stitch configured to freely slide over the corresponding strut when the frame is moved between the radially compacted and radially expanded states.

Claims

1. A replacement heart valve, comprising:

a valve body comprising an outer layer and an inner layer;

the outer layer being tubular and having a longitudinal axis, an upstream end and a downstream end, the outer layer formed from a thin, flexible material;

the inner layer being generally tubular, having a longitudinal axis generally collinear with the outer layer, and being positioned within the tubular outer layer, the inner layer formed from a thin, flexible material and defining a plurality of leaflets adapted to move between an open state and a coapted state, each leaflet having a side edge and a downstream portion, adjacent leaflets of the inner layer being connected by a commissural portion;

wherein the leaflets are attached to the outer layer along the leaflet side edges, and the commissural portions are attached to the outer layer downstream of at least a portion of the leaflet side edges; and

an elongate frame that can be radially compacted to a compacted state and radially expanded to an expanded state, the frame made up of a plurality of struts and having a longitudinal axis, the valve body being attached to the frame struts by a plurality of stitches;

wherein at least one of the plurality of stitches is a loose stitch configured to freely slide over the corresponding strut when the frame is radially compacted or expanded.

2. A replacement heart valve as in claim 1, wherein the inner and outer layers are constructed from a single, contiguous section of the flexible material.

3. A replacement heart valve as in claim 2, wherein the inner and outer layers are folded relative to one another at the upstream end so that the inner layer is contiguous with the outer layer at the upstream end.

4. A replacement heart valve as in claim 1, wherein the valve body is positioned so that the frame is adjacent an outer surface of the outer layer.

5. A replacement heart valve as in claim 4, wherein the outer layer of the valve body is connected to the frame, and the inner layer of the valve body is directly connected to the outer layer, but is not directly connected to the frame.

6. A replacement heart valve as in claim 1, wherein the thin, flexible layer from which the outer and inner layers are constructed is not substantially longitudinally stretchable.

7. A replacement heart valve as in claim 6, wherein the thin, flexible layer comprises pericardium.

8. A replacement heart valve as in claim 1, additionally comprising a longitudinally stretchable material attached to the outer layer.

9. A replacement heart valve as in claim 1, wherein the frame has a foreshortening portion.

10. A replacement heart valve as in claim 9, wherein the frame further has a non-foreshortening portion.

11. A replacement heart valve as in claim 10, wherein the strut to which the loose stitch is connected is in the non-foreshortening portion.

12. A replacement heart valve as in claim 10, wherein the valve body is positioned within the non-foreshortening portion.

13. A replacement heart valve as in claim 10, wherein the valve body is attached to the frame so that part of the valve body is in the foreshortening portion and part of the valve body is in the non-foreshortening portion.

14. A replacement heart valve as in claim 1, further comprising a longitudinally expandable material connected to the frame and the valve body.

15. A replacement heart valve as in claim 1, wherein the valve body comprises pericardium.

16. A replacement heart valve, comprising:

a valve body defining a plurality of leaflets adapted to move between an open state and a coapted state;

an elongate frame configured to move between a radially compacted state and a radially expanded state, the frame comprising a plurality of struts and having a longitudinal axis; and

a plurality of stitches which attach the valve body to the plurality of struts, wherein at least one of the plurality of stitches is a loose stitch configured to freely slide over the corresponding strut when the frame is moved between the radially compacted and radially expanded states.

17. A replacement heart valve as in claim 16, wherein the frame has a foreshortening portion.

18. A replacement heart valve as in claim 17, wherein the frame further has a non-foreshortening portion.

19. A replacement heart valve as in claim 18, wherein the strut to which the loose stitch is connected is in the non-foreshortening portion.

20. A replacement heart valve as in claim 18, wherein the valve body is positioned within the non-foreshortening portion.

21. A replacement heart valve as in claim 18, wherein the valve body is attached to the frame so that part of the valve body is in the foreshortening portion and part of the valve body is in the non-foreshortening portion.

22. A replacement heart valve as in claim 16, further comprising a longitudinally expandable material connected to the frame and the valve body.

23. A replacement heart valve as in claim 16, wherein the valve body comprises pericardium.