Replacement heart valve and method

• US 10,166,097 B2
• Filed: 01/29/2016
• Issued: 01/01/2019
• Est. Priority Date: 09/29/2009
• 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, Michiels, Robrecht
• Primary Examiner(s): Sharma, Yashita
• Assistant Examiner(s): Preston, Rebecca
• Application Number:
  US15/011,247
• Publication Number:
  US 20160143733A1
• Time in Patent Office: 1,068 Days
• 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 replacement heart valve for deployment at a diseased native valve, the replacement heart valve comprising:

an expandable frame configured to collapse radially to a first size for delivery and to expand radially to a second size upon deployment, the frame having an upstream end and a downstream end;

a valve body positioned within the expandable frame, the valve body comprising a plurality of valve leaflets configured to permit blood flow in a downstream direction and to prevent blood flow in an upstream direction; and

a material layer comprising one or more flaps positioned between the upstream and downstream ends of the frame along an exterior surface of the frame, each flap covering a corresponding opening in the replacement heart valve, wherein each flap is configured to allow blood to flow through the corresponding opening in a downstream direction when the frame is being expanded at the diseased native valve;

wherein each flap is attached at an upstream end of the corresponding opening.

2. The replacement heart valve of claim 1, wherein the one or more flaps comprise a plurality of flaps positioned around a circumference of the replacement heart valve that cover a plurality of the corresponding opening.

3. The replacement heart valve of claim 1, wherein the one or more flaps are configured to allow blood to flow through the corresponding openings from a location external the replacement valve to a location internal to the replacement valve.

4. The replacement heart valve of claim 3, wherein the location internal to the replacement valve is downstream of the plurality of valve leaflets.

5. The replacement heart valve of claim 1, wherein the exterior surface of the frame is configurable to have an at least partially conical shape to facilitate blood to flow through the corresponding openings.

6. The replacement heart valve of claim 1, wherein each of the valve leaflets has a scalloped, upstream edge.

7. The replacement heart valve of claim 6, wherein the one or more flaps are located downstream of the scalloped, upstream edges of the valve leaflets.

8. The replacement heart valve of claim 1, wherein the corresponding openings are located upstream of an upstream side of the valve leaflets.

9. A replacement heart valve for deployment at a diseased native valve, the replacement heart valve comprising:

an expandable frame comprising a proximal end and a distal end, the frame configured to radially expand and collapse for deployment at the diseased native valve, wherein the frame comprises a plurality of struts defining a plurality of cells;

a valve body comprising a plurality of valve leaflets, wherein each of the valve leaflets extends between a fixed proximal edge and a free distal edge, the free distal edges configured to open to allow flow in a first direction from the frame proximal end to the frame distal end and configured to alternatively close to prevent flow in a second direction from the frame distal end to the frame proximal end; and

a valve skirt attached to the expandable frame covering one or more of the cells of the frame, wherein the valve skirt defines one or more openings that are sized and configured to promote blood flow through the one or more openings, wherein the one or more openings are located proximally of the proximal edge of the valve leaflets; and

one or more flaps formed from a layer of material, each flap covering a corresponding one of the one or more openings defined by the valve skirt, wherein the one or more flaps are configured to allow blood to flow through the one or more openings in substantially one direction.

10. The replacement heart valve of claim 9, wherein the one or more openings are sized and configured to promote blood flow in substantially the second direction.

11. The replacement heart valve of claim 9, wherein the one or more openings are sized and configured to allow blood flow in the first direction.

12. A replacement heart valve for deployment at a diseased native valve, the replacement heart valve comprising:

an expandable frame comprising a proximal end and a distal end, the frame configured to radially expand and collapse for deployment at the diseased native valve, wherein the frame comprises a plurality of struts defining a plurality of cells;

a valve body comprising a plurality of valve leaflets, wherein each of the valve leaflets extends between a fixed proximal edge and a free distal edge, the free distal edges configured to open to allow flow in a first direction from the frame proximal end to the frame distal end and configured to alternatively close to prevent flow in a second direction from the frame distal end to the frame proximal end; and

a valve skirt attached to the frame covering one or more of the cells of the frame, wherein;

valve skirt comprises multiple layers of material that overlap one another, and

the valve skirt defines one or more openings that are sized and configured to promote blood flow through one or more cells of the frame covered by the valve skirt in the first direction, the one or more openings defined between the layers to allow blood to flow through the layers.

13. The replacement heart valve of claim 12, wherein the one or more openings are located at a portion of the frame configurable into a conical shape.

14. The replacement heart valve of claim 12, wherein each of the valve leaflets has a scalloped proximal edge.

15. The replacement heart valve of claim 14, wherein the one or more openings are located distal of the scalloped proximal edges of the valve leaflets.

16. The replacement heart valve of claim 12, wherein the plurality of valve leaflets are attached to the valve skirt.

17. The replacement heart valve of claim 12, wherein the one or more openings are located proximally of the proximal edge of the valve leaflets.