LEAFLET ATTACHMENT FRAME FOR A PROSTHETIC VALVE

• US 20090157175A1
• Filed: 12/15/2008
• Published: 06/18/2009
• Est. Priority Date: 12/14/2007
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Benichou, Netanel
• Granted Patent: US 9,510,942 B2
• Time in Patent Office: Days
• US Class Current: 623/2.180
• 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:

an upper frame section having a plurality of struts and a first leaflet receiving surface at a lower portion of the upper frame section;

a lower frame section having a second leaflet receiving surface at an upper portion of the lower frame section; and

at least one flexible leaflet with a first edge portion, the first edge portion being disposed between the first and second leaflet receiving surfaces.

2. The implantable prosthetic device of claim 1, wherein the first and second leaflet receiving surfaces are scalloped shaped.

3. The implantable prosthetic device of claim 1, further comprising one or more cloth portions, wherein the one or more cloth portions are attached to the flexible leaflet at or near the first edge portion and wrapped around at least a portion of one or both of the first and second receiving surfaces to secure the flexible leaflet to the upper and lower frame sections.

4. The implantable prosthetic device of claim 3, wherein the one or more cloth portions are attached to the flexible leaflet so that a first excess cloth portion extends away from the first edge portion on an upper side of the flexible leaflet and a second excess cloth portion extends away from the first edge portion on a lower side of the flexible leaflet, wherein the first and second excess cloth portions are wrapped around the respective first and second leaflet receiving surface and secured to one another.

5. The implantable prosthetic device of claim 1, wherein the upper and lower frame sections are configured to be expanded from a first configuration to a second configuration, and the lengths of the first and second leaflet receiving surfaces are substantially the same in both the first and second configurations.

6. The implantable prosthetic device of claim 1, wherein the first leaflet receiving surface comprises an arc section, the arc section being defined as a portion of the leaflet receiving surface that is located between one or more struts that extend away from the first leaflet receiving surface, wherein the length of the arc section is substantially equal to the combined length of one or more struts on the upper frame section.

7. The implantable prosthetic device of claim 1, wherein the upper frame section and the lower frame section are connected via one or more struts.

8. An implantable prosthetic device comprising:

a frame comprising a plurality of frame sections, each frame section having a lower portion with a scalloped shape; and

a flexible membrane comprising a plurality of flexible leaflets, each flexible leaflet having a lower portion with a scalloped shape;

wherein the lower portion of each flexible leaflet is attached to the lower portion of each frame section.

9. The implantable prosthetic device of claim 8, wherein the lower portion of each frame section comprises a first part and a second part, the first and second parts being spaced apart to receive the lower portion of the flexible leaflets in an opening formed therebetween.

10. The implantable prosthetic device of claim 9, wherein one or more cloth portions are attached to each flexible leaflet, the cloth portions wrapping around at least a portion of the first and second parts to secure the flexible leaflets to the frame.

11. The implantable prosthetic device of claim 8, wherein the frame further comprising first and second vertical posts at an upper area between two frame sections, 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.

12. The implantable prosthetic device of claim 11, 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.

13. A method of assembling an implantable prosthetic valve comprising a flexible membrane and crimpable frame with an upper and lower part, the method comprising:

partially crimping the frame to have a diameter that is less than the diameter of the frame when the valve is expanded to its functional size;

positioning an edge of the flexible membrane between the upper and lower part of the frame; and

securing the edge of the flexible membrane to both the upper and lower part of the frame.

14. The method of claim 13, farther comprising:

attaching a cloth portion to the edge of the flexible leaflet so that a first excess cloth portion extends away from the edge on an upper side of the flexible membrane and a second excess cloth portion extends away from the edge on a lower side of the flexible membrane;

wrapping the first excess cloth portion around at least a portion of the upper part of the frame;

wrapping the second excess cloth portion around at least a portion of the lower part of the frame; and

securing the first and second excess cloth portions to each other at an area radially outside of the frame.