Replacement valve and method

• US 9,730,790 B2
• Filed: 02/23/2012
• Issued: 08/15/2017
• 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, J. Brent, Michiels, Robrecht, Quadri, Arshad
• Primary Examiner(s): Sharma, Yashita
• Assistant Examiner(s): PRESTON, REBECCA STRASZHEIM
• Application Number:
  US13/403,929
• Publication Number:
  US 20120215303A1
• Time in Patent Office: 2,000 Days
• Field of Search: 623 124, 623 126, 623 21- 219
• 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 valve has an expandable frame configured to engage a native valve 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. An intralumenal valve assembly for deployment at a diseased native valve, the intralumenal valve assembly comprising:

an expandable frame comprising a proximal end, a distal end, and a longitudinal axis extending therethrough, 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 and wherein a diameter of the proximal end is less than a diameter of a portion of the frame located distal to the proximal end, the portion of the frame located distal to the proximal end being configured to be positioned about a native valve annulus; and

a valve body comprising;

a valve skirt attached to the expandable frame, the valve skirt comprising a proximal end positioned near the proximal end of the frame and extending longitudinally along a length of the frame to a distal end at or near the distal end of the frame, wherein the proximal end of the valve skirt comprises edges extending at least partially distally from a proximalmost portion of the valve skirt along a length of the frame so that portions of the plurality of cells are exposed proximal to the edges, the exposed portions of the cells forming openings between struts of the frame to permit the entry of blood into the expandable frame generally transverse to the longitudinal axis, wherein the proximalmost portion of the valve skirt is spaced distally from the proximal end of the frame; and

a plurality of valve leaflets attached to the skirt, 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.

2. The intralumenal valve assembly of claim 1, wherein the proximal end of the valve skirt comprises tapered edges.

3. The intralumenal valve assembly of claim 1, wherein the expandable frame comprises one or more rows of undulating struts at the proximal end of the frame.

4. The intralumenal valve assembly of claim 3, wherein the edges at the proximal end of the valve skirt extend across without following the shape of at least some of the undulating struts.

5. The intralumenal valve assembly of claim 3, wherein the edges at the proximal end of the valve skirt extend at least partially distally away from the undulating struts so that portions of the plurality of cells formed by the undulating struts are exposed proximal to the edges.

6. The intralumenal valve assembly of claim 1, further comprising a support band at the proximal end of the expandable frame configured to limit expansion of the expandable frame, the support band positioned so as to permit the exposed portions of the cells proximal to the edges at the proximal end of the valve skirt to remain open for transverse influx of blood therethrough during use.

7. The intralumenal valve assembly of claim 1, wherein the valve skirt further comprises a plurality of slits or gills.

8. The intralumenal valve assembly of claim 1, wherein the frame comprises proximal anchors and distal anchors positioned on opposite sides of one or more rows of foreshortening cells, wherein expansion of the frame causes the proximal anchors and distal anchors to move toward each other.

9. The intralumenal valve assembly of claim 1, wherein a diameter of the expandable frame at the proximalmost portion of the valve skirt is less than a diameter of the expandable frame at a distalmost portion of the valve skirt.

10. The intralumenal valve assembly of claim 1, wherein a diameter of the expandable frame at a proximalmost end of the frame is less than a diameter of distalmost end of the frame.

11. An intralumenal valve assembly for deployment at a diseased native valve, the intralumenal valve assembly comprising:

an expandable frame comprising a proximal end, a distal end, and a longitudinal axis extending therethrough, 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 and wherein a diameter of the proximal end is less than a diameter of a portion of the frame located distal to the proximal end, the portion of the frame located distal to the proximal end being configured to be positioned about a native valve annulus; and

a valve body comprising;

a valve skirt attached to the expandable frame, the valve skirt comprising a proximal end positioned at or near the proximal end of the frame and extending longitudinally along a length of the frame to a distal end at or near the distal end of the frame, wherein the proximal end of the valve skirt comprises edges extending at least partially distally from a proximalmost portion of the valve skirt along a length of the frame so that portions of the plurality of cells are exposed proximal to the edges, the exposed portions of the cells forming openings between struts of the frame to permit the entry of blood into the expandable frame generally transverse to the longitudinal axis; and

a plurality of valve leaflets attached to the skirt, 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,

wherein the proximal end of the valve skirt comprises scalloped, arcuate edges;

wherein each of the fixed, proximal edges of the valve leaflets has an arcuate shape; and

wherein each of the fixed, proximal edges of the valve leaflets is secured to one of the scalloped, arcuate edges of the valve skirt.

12. An intralumenal valve assembly for deployment at a diseased native valve, the intralumenal valve assembly comprising:

an expandable frame comprising a proximal end, a distal end, and a longitudinal axis extending therethrough, 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 and wherein a diameter of the proximal end is less than a diameter of a portion of the frame located distal to the proximal end, the portion of the frame located distal to the proximal end being configured to be positioned about a native valve annulus; and

a valve body comprising;

a valve skirt attached to the expandable frame, the valve skirt comprising a proximal end positioned at or near the proximal end of the frame and extending longitudinally along a length of the frame to a distal end at or near the distal end of the frame, wherein the proximal end of the valve skirt comprises edges extending at least partially distally from a proximalmost portion of the valve skirt along a length of the frame so that portions of the plurality of cells are exposed proximal to the edges, the exposed portions of the cells forming openings between struts of the frame to permit the entry of blood into the expandable frame generally transverse to the longitudinal axis; and

a plurality of valve leaflets attached to the skirt, 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,

wherein the frame comprises undulating struts at its distal end, and the distal end of the valve skirt has an undulating shape corresponding to the undulating struts at the distal end of the frame.

13. An intralumenal valve assembly for deployment at a diseased native valve, the intralumenal valve assembly comprising:

an expandable frame comprising a proximal end, a distal end, and a longitudinal axis extending therethrough, 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 and wherein a diameter of the proximal end is less than a diameter of a portion of the frame located distal to the proximal end, the portion of the frame located distal to the proximal end being configured to be positioned about a native valve annulus; and

a valve body comprising;

a valve skirt attached to the expandable frame, the valve skirt comprising a proximal end positioned at or near the proximal end of the frame and extending longitudinally along a length of the frame to a distal end at or near the distal end of the frame, wherein the proximal end of the valve skirt comprises edges extending at least partially distally from a proximalmost portion of the valve skirt along a length of the frame so that portions of the plurality of cells are exposed proximal to the edges, the exposed portions of the cells forming openings between struts of the frame to permit the entry of blood into the expandable frame generally transverse to the longitudinal axis; and

a plurality of valve leaflets attached to the skirt, 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,

wherein the valve skirt comprises three valve skirt portions connected to each other at connecting edges that extend only partially along a length of the frame.

14. An intralumenal valve assembly for deployment at a native mitral valve, the intralumenal valve assembly comprising:

an expandable frame comprising;

a proximal end, a distal end, and a longitudinal axis extending therethrough, the frame configured to radially expand and collapse for deployment at the native mitral valve and wherein a diameter of the proximal end is less than a diameter of a portion of the frame located distal to the proximal end, the portion of the frame located distal to the proximal end being configured to be positioned about a native mitral valve annulus;

a first set of anchors comprising ends extending proximally, the ends configured to contact the native mitral valve annulus on a left ventricular side;

a valve body, wherein the valve body has a proximal end spaced distally from the proximal end of the frame; and

a support band at or near the proximal end of the frame, the support band being positioned proximal to the valve body and configured to limit expansion of the expandable frame.

15. The intralumenal valve assembly of claim 14, wherein the valve body comprises a valve skirt attached to the expandable frame and a plurality of valve leaflets attached to the valve skirt.

16. The intralumenal valve assembly of claim 15, 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.

17. The intralumenal valve assembly of claim 14, wherein gaps are formed between the support band and the proximal end of the valve body to permit a transverse influx of blood through the frame during use.

18. The intralumenal valve assembly of claim 14, wherein the support band comprises a non-elastic material.

19. The intralumenal valve assembly of claim 14, wherein the frame comprises a second set of anchors, wherein the first and second sets of anchors are positioned on opposite sides of one or more rows of foreshortening cells, wherein expansion of the frame causes the first and second sets of anchors to move toward each other.