Prosthetic Heart Valve Having an Improved Tubular Seal

• US 20160262878A1
• Filed: 03/03/2016
• Published: 09/15/2016
• Est. Priority Date: 03/13/2015
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Crow, Loren M., Backus, Andrew J.H.
• Granted Patent: US 10,080,652 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2210/0057 stretchable
• 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 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/0037 differing in height or in length
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

A tubular seal includes an outflow end region and an inflow end region. The inflow end region is a portion of a polymeric web retaining a woven fabric, wherein the woven fabric has a non-linear edge defining an interface between the inflow end region and the outflow end region.

Claims

1. A prosthetic heart valve comprising:

an expandable tubular member;

a plurality of leaflets secured together alongside edges and retained within the expandable tubular member, each leaflet having a bottom edge at a blood inflow end of the expandable tubular member and a free edge at a blood outflow end of the expandable tubular member; and

a tubular seal comprising a polymeric web secured to the bottom edge of each leaflet and along an outer portion of the expandable tubular member, wherein the tubular seal comprising an outflow end region and an inflow end region, the inflow end region being a portion of polymeric web retaining a woven fabric, wherein the woven fabric has a non-linear edge defining the interface between the inflow end region and the outflow end region.

2. The prosthetic heart valve of claim 1, wherein polymeric web comprising an elastomeric polymer matrix and the woven fabric is retained within the elastomeric polymer matrix.

3. The prosthetic heart valve of claim 1, wherein the woven fabric comprises the non-elastic fibers.

4. The prosthetic heart valve of claim 3, wherein the woven fabric comprises fibers in a warp direction and fibers in a waft direction, wherein the fibers in both the warp direction and the waft direction are angled with respect to a central axis of the tubular seal.

5. The prosthetic heart valve of claim 4, wherein the fibers in both the warp direction and the waft direction are angled at an angle of between 5 degrees and 70 degrees with respect to the central axis of the tubular seal.

6. The prosthetic heart valve of claim 4, wherein the fibers are arranged within the tubular member to form an angle of about 45 degrees with respect to the central axis of the tubular seal.

7. The prosthetic heart valve of claim 1, wherein the woven fabric comprises non-elastic fibers arranged in the polymeric web to allow the tubular seal to stretch in axial and radial directions.

8. The prosthetic heart valve of claim 1, wherein the non-linear edge of the woven fabric has a sinusoidal or scalloped shape.

9. The prosthetic heart valve of claim 1, wherein the inflow end region comprises a first substantially uniform thickness and the outflow end region comprises median thickness that is less than the first substantially uniform thickness.

10. The prosthetic heart valve of claim 1, wherein the outflow end region comprises a plurality of grommets.

11. A tubular seal for a prosthetic heart valve comprising:

an elastomeric polymer matrix and a woven fabric comprising a plurality of non-elastic fibers retained within an inflow end region of the elastomeric polymer matrix, wherein the woven fabric comprising a non-linear edge within the elastomeric polymer matrix.

12. The tubular seal of claim 11, wherein the non-linear edge of the woven fabric has a sinusoidal or scalloped shape defining an interface between the inflow end region and the outflow end region.

13. The tubular seal of claim 12, wherein the interface has a major radius R_a that ranges from about 0.050 inches to about 0.100 inches.

14. The tubular seal of claim 12, wherein interface has a minor radius R_i that ranges from about from about 0.020 inches to about 0.040 inches.

15. The tubular seal of claim 12, wherein the interface has a transition zone length that ranges from about 0.110 inches to about 0.160 inches.

16. The tubular seal of claim 11, wherein the non-elastic fibers comprise a polyester.

17. The tubular seal of claim 11, wherein the elastomeric polymer matrix comprises a polymer selected from polycarbonates, polyurethane, silicones, and combinations thereof.

18. The tubular seal of claim 11, wherein the inflow end region comprises a first substantially uniform thickness and the outflow end region comprises median thickness that is less than the first substantially uniform thickness.

19. The tubular seal of claim 11, wherein a thickness for the inflow end region ranges from about 0.0016 inches to about 0.0023 inches, or from about 40 microns to about 60 microns.

20. A method comprising:

forming at least a portion of a tubular seal that includes a woven fabric within a matrix by dipping a mandrel with a first coating composition comprising at least one elastomeric polymer;

drying the first coating composition;

positioning the woven fabric on the mandrel such that fibers within the fabric are oriented at an angle of about 45 degrees with respect to a central axis of the tubular seal;

applying a second coating composition on the mandrel, the second coating composition being different than the first coating composition; and

removing the tubular seal from the mandrel.