Leaflet attachment frame for a prosthetic valve

• US 9,510,942 B2
• Filed: 12/15/2008
• Issued: 12/06/2016
• Est. Priority Date: 12/14/2007
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Benichou, Netanel
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): WOLF, MEGAN YARNALL
• Application Number:
  US12/335,461
• Publication Number:
  US 20090157175A1
• Time in Patent Office: 2,913 Days
• Field of Search: 623/1.13, 623 124- 126, 623 212- 219, 623/910
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• 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 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• 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

Abstract

An implantable prosthetic valve has an upper frame section and a lower frame section. The upper frame section has a plurality of struts and a first leaflet receiving surface at a lower portion of the upper frame section. The lower frame section has a second leaflet receiving surface at an upper portion of the lower frame section. An edge of a flexible leaflet is disposed between the first and second leaflet receiving surfaces to attach the leaflet to the upper and lower frame sections.

Claims

1. An implantable prosthetic device comprising:

a crimpable, multipart frame comprising a plurality of frame parts, each frame part having a lower portion with a scalloped shape, wherein the lower portion of each frame part comprises a first part and a second part, the first and second parts being spaced apart to create a gap;

a flexible membrane comprising a plurality of flexible leaflets, each flexible leaflet having a lower portion with an edge; and

one or more cloth portions attached to the edge of each flexible leaflet to create a leaflet attachment portion, each cloth portion further comprising a first excess cloth portion and a second excess cloth portion, wherein the first excess cloth portion extends away from an upper side of each leaflet attachment portion and the second excess cloth portion extends away from a lower side of each leaflet attachment portion;

wherein each leaflet attachment portion is positioned in the gap between the first and second part of the lower portion of each frame part, each first excess cloth portion is wrapped around at least a portion of the first part of each frame part, each second excess cloth portion is wrapped around at least a portion of the second part of each frame part, and each first and second excess cloth portions are secured together at an area radially outside of the frame, and

wherein the multipart frame in a crimped state is deliverable through a patient'"'"'s vasculature;

wherein the frame further comprises first and second vertical posts at an upper area between two frame parts, the two vertical posts being spaced apart and defining an opening for receiving a first portion of a first flexible leaflet and a second portion of a second flexible leaflet, wherein both the first and second portions are attached to a first and second cloth portion, respectively, the first and second cloth portions wrapping around at least a portion of the first and second vertical posts, respectively, to attach the flexible leaflets to the frame.

2. The implantable prosthetic device of claim 1, further comprising a third cloth portion positioned radially outside of the frame, wherein the first and second leaflets are secured to the frame by attaching the first and second cloth portions to the third cloth portion.

3. An implantable prosthetic device comprising:

a collapsible and expandable, multipiece frame comprising;

an upper piece comprising a plurality of strut sections and a first arc section; and

a lower piece comprising a second arc section;

a valve assembly comprising a flexible membrane defining at least one flexible leaflet, the flexible membrane comprising a lower edge portion, the lower edge portion of the flexible membrane captured between and spacing apart the first arc section of the upper piece of the frame and the second arc section of the lower piece of the frame; and

a cloth member attached to the lower edge portion of the flexible membrane, the cloth member wrapping around and sandwiching the lower edge portion of the flexible membrane between two layers thereof and sutured to the lower edge of the flexible membrane, excess portions of the cloth member wrapped over and around the first arc section and the second arc section, the excess portions of the cloth member sewn together, securing the cloth member to the frame.

4. The implantable prosthetic device of claim 3, wherein the frame is balloon expandable or self-expanding.

5. The implantable prosthetic device of claim 3, wherein a length of the first arc section and a length of the second arc section are substantially the same.

6. The implantable prosthetic device of claim 5, wherein a length of the lower edge portion of the flexible membrane is substantially the same as the length of the first arc section and a length of the second arc section.

7. The implantable prosthetic device of claim 3, wherein the lower piece further comprises struts.

8. The implantable prosthetic device of claim 3, wherein

the upper piece further comprises a first vertical strut and a second vertical strut spaced from the first vertical strut, defining an opening therebetween,

the at least one flexible leaflet of the flexible membrane comprising a plurality of flexible leaflets,

portions of adjacent flexible leaflets extend through the opening between the first vertical strut and the second vertical strut, and

portions of the cloth member wrap around the first vertical strut and the second vertical strut, and are sutured to portions of the adjacent flexible leaflets extending through the opening between the first vertical strut and the second vertical strut.

9. The implantable prosthetic device of claim 3, wherein the flexible membrane comprises at least one of natural tissue, pericardial tissue, and a harvested natural valve.

10. The implantable prosthetic device of claim 3, wherein the cloth member comprises at least one of a biocompatible synthetic material, woven polyester, polyethylene terephthalate (PET), and polytetrafluoroethylene (PTFE).

11. The implantable prosthetic device of claim 3, wherein the flexible membrane is not directly sutured to the frame.