Leaflet in configuration for function in various shapes and sizes

• US 9,554,902 B2
• Filed: 02/28/2013
• Issued: 01/31/2017
• Est. Priority Date: 06/28/2012
• Status: Active Grant

• Current Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories)
• Original Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories)
• Inventors: Ahmann, Katherine A., Braido, Peter Nicholas, Fahim, Mina Safwat, Allison, Jeffrey J., McCarthy, Andrea L.
• Primary Examiner(s): Iwamaye, Andrew
• Assistant Examiner(s): Lopez, Leslie
• Application Number:
  US13/781,423
• Publication Number:
  US 20140005771A1
• Time in Patent Office: 1,433 Days
• Field of Search: 623/1.24, 623/1.26, 623/2.1, 623/2.12, 623/2.14, 623/2.15, 623/2.16, 623/2.17
• 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 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0066 stapled
• 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 2250/0017 differing in yarn density
• CPC Class Codes: F04C 2270/0421 Controlled or regulated

Abstract

A prosthetic heart valve includes a collapsible and expandable stent having a proximal end, a distal end, an annulus section adjacent the proximal end and an aortic section adjacent the distal end. The heart valve further includes a plurality of commissure features disposed on the stent, and a collapsible and expandable valve assembly, the valve assembly including a plurality of leaflets connected to the plurality of commissure features, each of the plurality of leaflets having a free edge and being configured to have a tension line aligned near the free edge to prevent backflow.

Claims

1. A prosthetic heart valve for replacing the function of a native heart valve, comprising:

a collapsible and expandable stent having a proximal end, a distal end, an annulus section adjacent the proximal end and an aortic section adjacent the distal end, the stent being radially compressible and configured for transcatheter delivery;

a plurality of commissure features disposed on the stent;

a collapsible and expandable valve assembly, the valve assembly including a cuff, a plurality of leaflets, each of the plurality of leaflets including a free edge, tabs disposed on two sides of the free edge and connected to the plurality of commissure features, and an attachment portion having a body portion and a foldover portion, the attachment portion being disposed between the tabs and opposite the free edge for coupling to at least one of the stent and the cuff; and

a plurality of discrete reinforcements, each discrete reinforcement being coupled to only one attachment portion of a selected leaflet and bounded by the tabs of the selected leaflet, and being spaced from the free edge of the selected leaflet;

wherein the discrete reinforcement is coupled to each of the plurality of leaflets using a suture and the suture forms a whip stitch external to and around the discrete reinforcement and its representative leaflet of the plurality of leaflets wherein the whip stitch passes through the foldover portion and the body portion.

2. The prosthetic heart valve of claim 1, wherein at least one of the plurality of discrete reinforcements comprises at least one of a cord, a wire and a suture.

3. The prosthetic heart valve of claim 1, wherein at least one of the plurality of discrete reinforcements comprises a strip of fabric.

4. A prosthetic heart valve for replacing the function of a native heart valve, comprising:

a collapsible and expandable stent having a proximal end, a distal end, an annulus section adjacent the proximal end and an aortic section adjacent the distal end, the stent being radially compressible and configured for transcatheter delivery;

a plurality of commissure features disposed on the stent;

a collapsible and expandable valve assembly, the valve assembly including a cuff, a plurality of leaflets, each of the plurality of leaflets including a free edge, tabs disposed on two sides of the free edge and connected to the plurality of commissure features, and an attachment portion having a body portion and a foldover portion, the attachment portion being disposed between the tabs and opposite the free edge for coupling to at least one of the stent and the cuff;

a plurality of discrete reinforcements, each discrete reinforcement being coupled to only one attachment portion of a selected leaflet and bounded by the tabs of the selected leaflet, and being spaced from the free edge of the selected leaflet, the foldover portion wrapping around the discrete reinforcement; and

wherein each of the plurality of leaflets has coupled to it a single loop of suture that begins at a first side of a respective leaflet of the plurality of leaflets, passes through the body portion, through the foldover portion, through the foldover portion a second time, and forms a loop to end back at the first side of the respective leaflet.

5. The prosthetic heart valve of claim 4, wherein at least one of the plurality of discrete reinforcements comprises at least one of a cord, a wire and a suture.

6. The prosthetic heart valve of claim 4, wherein at least one of the plurality of discrete reinforcements comprises a strip of fabric.