Replacement valve and method

Patent metadata

Field	Value
Publication number	US-9730790-B2
Application number	US-201213403929-A
Country	US
Kind code	B2
Filing date	Feb 23, 2012
Priority date	Sep 29, 2009
Publication date	Aug 15, 2017
Grant date	Aug 15, 2017

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.

First claim

What is claimed is:

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 e

Assignees

• Quadri Arshad
• Ratz J Brent
• Michiels Robrecht
• Edwards Lifesciences Cardiaq Llc

Inventors

• Quadri Arshad
• Ratz J Brent
• Michiels Robrecht

Classifications

• A61F2/24

  Heart valves {; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body} · CPC title

• A61F2230/0054

  V-shaped · CPC title

• A61F2220/0075

  sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable · CPC title

• A61F2/2427

  Devices for manipulating or deploying heart valves during implantation · CPC title

• A61F2250/0039

  differing in diameter · CPC title