REPLACEMENT HEART VALVE AND METHOD

• US 20120215303A1
• Filed: 02/23/2012
• Published: 08/23/2012
• Est. Priority Date: 09/29/2009
• Status: Active Grant

• Current Assignee: Edwards Lifesciences CardiAQ LLC (Edwards Lifesciences Corporation)
• Original Assignee: Cardiaq Valve Technologies Incorporated
• Inventors: Quadri, Arshad, Ratz, J. Brent, Michiels, Robrecht
• Granted Patent: US 9,730,790 B2
• Time in Patent Office: Days
• US Class Current: 623/2.18
• 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 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• 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 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• 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 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2250/0069 Sealing means
• CPC Class Codes: A61F 2250/0071 breakable or frangible

Abstract

A replacement heart valve has an expandable frame configured to engage a native valve annulus and a valve body mounted to the expandable frame. The valve body can have a plurality of valve leaflets configured to open to allow flow in a first direction and engage one another so as to close and prevent flow in a second direction, the second direction being opposite the first direction.

Claims

1. A method of implanting a replacement heart valve comprising:

advancing a replacement heart valve to a native valve annulus;

expanding a frame of the replacement heart valve from a compacted position to a first expanded configuration such that anchors on the replacement heart valve engage the native valve annulus; and

reducing the diameter of the frame from the first expanded configuration to a second expanded configuration while the anchors remain engaged with the native valve annulus.

2. The method of claim 1, wherein reducing the diameter further comprises deploying an outer ring positioned around the frame, the outer ring having a relaxed diameter less than a diameter of the frame when in the first expanded configuration.

3. The method of claim 2, further comprising proving heat to the outer ring through a power source to cause the outer ring to adjust toward its relaxed diameter.

4. The method of claim 1, wherein reducing the diameter further comprises tensioning a cord member disposed about the frame.

5. The method of claim 4, further comprising tensioning the cord member until at least one stop member engages an eyelet on the frame.

6. A replacement heart valve comprising:

a self-expandable frame configured to engage a native valve annulus when in an expanded configuration, the self-expandable frame having a first diameter when in a relaxed, fully expanded configuration;

a valve body mounted to the self-expandable frame, the valve body comprising a plurality of valve leaflets configured to open to allow flow in a first direction and engage one another so as to close and prevent flow in a second direction, the second direction being opposite the first direction;

a tether or ring having a second diameter when in a relaxed, fully expanded configuration, the tether or ring being fit about a portion of the self-expandable frame;

wherein the first diameter is greater than the second diameter.

7. The replacement heart valve of claim 6, wherein the tether or ring is self-expandable.

8. The replacement heart valve of claim 6, wherein the tether or ring comprises a cord member disposed about a downstream end of the frame, the cord member having a first end and a second end extending proximally away from the self-expandable frame, wherein a predetermined tension applied to the first end and the second end applies a force to the frame to compact the frame to a third diameter that is less than the first diameter.

9. The replacement heart valve of claim 6, further comprising an elongate flexible member disposed about the downstream end of the expandable frame, the elongate flexible member having at least one stop member configured to engage a portion of the frame and limit frame expansion.

10. The replacement heart valve of claim 6, further comprising a first anchor and a second anchor, each of the first and second anchors extending towards the other and ending in an anchor tip, the anchor tips configured to move towards one another as the self-expandable frame moves from a compacted configuration to the expanded configuration to thereby grasp a native valve annulus therebetween.

11. The replacement heart valve of claim 10, further comprising a third anchor and a fourth anchor, each of the third and fourth anchors extending towards the other and ending in an anchor tip, the anchor tips configured to move towards one another as the self-expandable frame compacts from the first diameter of the expanded configuration to a third diameter that is less than the first diameter to thereby grasp a native valve annulus therebetween.

12. A replacement heart valve comprising:

an expandable frame configured to engage a native valve annulus;

a valve body mounted onto the expandable frame, the valve body having an upstream end and a downstream end, the valve body comprising;

a valve skirt configured to engage the expandable frame through a series of stitches;

a plurality of valve leaflets configured to open to allow flow in a first direction and engage one another so as to close and not allow flow in a second direction opposite the first direction, the valve leaflets being attached to the valve skirt;

an upstream edge of each valve leaflet being arcuate;

a portion of the skirt having an arcuate upstream edge substantially aligned with the valve leaflet upstream edges;

wherein the aligned skirt and valve leaflet upstream edges are attached to one another.

13. The replacement heart valve of claim 12, wherein the upstream end of the valve skirt has scalloped end geometry corresponding to the upstream edges of the leaflets.

14. The replacement heart valve of claim 12, wherein the upstream end of the valve skirt is substantially aligned with the upstream ends of the valve leaflets substantially around the circumference of the valve body.

15. The replacement heart valve of claim 12, wherein the plurality of leaflets further comprise commissural tabs extending outward from the leaflets, the leaflet member configured to be coupled to a longitudinal member of the frame.

16. The replacement heart valve of claim 15, wherein the commissural tabs extend through a longitudinal stitch along the valve skirt so that the commissural tabs are outside of the valve skirt.

17. The replacement heart valve of claim 16, wherein the commissural tabs are the only part of the valve body located on an outer surface of the frame.

18. The replacement heart valve of claim 12, wherein the skirt comprises a plurality of skirt pieces sewn together along a stitch line, wherein the stitch line extends only a portion of the length of the skirt, and an upstream portion of the skirt is proximal of the stitch line.

19. The replacement heart valve of claim 18, wherein the aligned skirt and valve leaflet upstream edges are within the upstream portion of the skirt.

20. The replacement heart valve of claim 12, wherein an upstream portion of the expandable frame extends proximally of the upstream edge of the skirt, and additionally comprising a support band attached to the upstream portion of the expandable frame, the support band configured to constrain expansion of the upstream portion of the expandable frame.

21. The replacement heart valve of claim 12, wherein the upstream end of the heart valve has a plurality of spaced gaps between portions of the valve skirt that establish flow paths through the upstream portion of the replacement heart valve.