REPLACEMENT HEART VALVE AND METHOD

• US 20160143733A1
• Filed: 01/29/2016
• Published: 05/26/2016
• 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: Ratz, Jeremy Brent, Quadri, Arshad, Michiels, Robrecht
• Granted Patent: US 10,166,097 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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

1-21. -21. (canceled)

22. 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

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

23. The replacement heart valve of claim 22, comprising a plurality of flaps positioned around a circumference of the replacement heart valve that cover a plurality of openings.

24. The replacement heart valve of claim 22, further comprising a valve skirt attached to the frame, wherein the one or more flaps cover one or more openings in the valve skirt.

25. The replacement heart valve of claim 22, wherein the one or more flaps are configured to allow blood to flow through the one or more openings from a location external the replacement valve to a location internal to the replacement valve.

26. The replacement heart valve of claim 25, wherein the location internal to the replacement valve is downstream of the plurality of valve leaflets.

27. The replacement heart valve of claim 22, wherein the one or more flaps are attached at an upstream end of an opening in the replacement heart valve.

28. The replacement heart valve of claim 22, wherein the exterior surface of the frame is configurable to have an at least partially conical shape to facilitate blood to flow through the one or more openings.

29. The replacement heart valve of claim 22, wherein each of the valve leaflets has a scalloped, upstream edge.

30. The replacement heart valve of claim 29, wherein the one or more flaps are located downstream of the scalloped, upstream edges of the valve leaflets.

31. 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 one or more cells of the frame covered by the valve skirt in the first direction.

32. The replacement heart valve of claim 31, wherein the one or more openings are located at a portion of the frame configurable into a conical shape.

33. The replacement heart valve of claim 31, wherein the valve skirt comprises a plurality of slits or gills.

34. The replacement heart valve of claim 31, wherein the valve skirt comprises one or more flaps.

35. The replacement heart valve of claim 31, wherein the valve skirt comprises multiple layers of material that overlap one another to define openings between the layers to allow blood to flow through the layers.

36. The replacement heart valve of claim 31, wherein each of the valve leaflets has a scalloped proximal edge.

37. The replacement heart valve of claim 36, wherein the one or more openings are located distal of the scalloped proximal edges of the valve leaflets.

38. The replacement heart valve of claim 31, wherein the plurality of valve leaflets are attached to the valve skirt.

39. A method of delivering a replacement heart valve to a diseased native valve, the method comprising:

advancing a replacement heart valve comprising an expandable frame and a valve body attached to the expandable frame to a native valve annulus, wherein the frame comprises a plurality of cells and is in a radially compacted configuration when the replacement heart valve is advanced, and wherein the valve body comprises a plurality of leaflets configured to open to allow flow in a first direction from a frame proximal end to a 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

expanding the frame from the radially compacted configuration to an expanded configuration at the native valve annulus, wherein when the frame is in the expanded configuration;

the replacement heart valve comprises one or more openings covered by one or more flaps; and

blood flows through the one or more openings in the first direction.

40. The method of claim 39, wherein blood flows through the one or more openings prior to complete implantation of the replacement heart valve.

41. The method of claim 39, wherein when the frame is in the expanded configuration, the one or more openings covered by one or more flaps are provided in a conical portion of the frame.