PROSTHETIC HEART VALVE HAVING TUBULAR SEAL

• US 20160220360A1
• Filed: 01/28/2016
• Published: 08/04/2016
• Est. Priority Date: 02/03/2015
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Finnegan, Christopher B., Crowley, Cornelius M., Hammer, Nadina, Pumares, Marissa, Jerczynska, Dominika, Byrne, Patricia, Luong, Laura, Lin, John, Miracle, Christopher M.
• Granted Patent: US 10,201,417 B2
• Time in Patent Office: Days
• 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 2/2418 Scaffolds therefor, e.g. support stents
• 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 2250/0069 Sealing means

Abstract

A tubular seal for a prosthetic heart valve includes an elastomeric polymer matrix and a plurality of non-elastic fibers retained within the matrix. The non-elastic fibers can be arranged in the elastomeric polymer matrix to allow the tubular seal to stretch in axial and radial directions.

Claims

1. A prosthetic heart valve comprising:

an expandable tubular member;

a plurality of leaflets secured together along side 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 secured to the bottom edge of each leaflet and along an outer portion of the expandable tubular member, wherein the tubular seal comprises an elastomeric polymer matrix and a plurality of non-elastic fibers retained within the matrix, and wherein the non-elastic fibers are arranged in the elastomeric polymer matrix to allow the tubular seal to stretch in axial and radial directions.

2. The prosthetic heart valve of claim 1, wherein the non-elastic fibers are part of a fabric.

3. The prosthetic heart valve of claim 2, wherein the fabric is a woven fabric.

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 3, wherein the fibers in both the warp direction and the waft direct 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 1, wherein the non-elastic fibers are uniformly dispersed throughout the elastomeric polymer matrix.

7. The prosthetic heart valve of claim 6, wherein the tubular seal has a substantially uniform thickness.

8. The prosthetic heart valve of claim 6, wherein the tubular seal comprises an outflow end region and an inflow end region, the inflow end region being a portion of the tubular seal comprising the fabric, wherein the fabric has a non-linear edge defining the interface between the inflow end region and the outflow end region.

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

10. The prosthetic heart valve of claim 8, 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.

11. The prosthetic heart valve of claim 8, wherein the outflow end region comprises a plurality of grommets.

12. The prosthetic heart valve of claim 1, wherein the tubular seal has a thickness range from about 30 microns to about 75 microns.

13. The prosthetic heart valve of claim 1, wherein the tubular seal has a thickness range from about 50 microns to about 120 microns.

14. A prosthetic heart valve comprising:

an expandable tubular member;

a plurality of leaflets secured together along side 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 an elastomeric polymer matrix and a fabric comprising a plurality of non-elastic fibers retained within an inflow end portion of the elastomeric polymer matrix, the inflow end portion of the tubular seal being secured to the bottom edges of the plurality of leaflets, wherein the fabric comprises a non-linear edge within the elastomeric polymer matrix.

15. The prosthetic heart valve of claim 14, wherein the non-linear edge of the fabric has a sinusoidal or scalloped shape.

16. The prosthetic heart valve of claim 14, wherein the non-elastic fibers comprise a polyester.

17. The prosthetic heart valve of claim 14, wherein the elastomeric polymer matrix comprises a first material composition and a second material composition, wherein the first material composition is different than the second material composition.

18. The prosthetic heart valve of claim 14, wherein the elastomeric polymer matrix comprises a polymer selected from polycarbonates, polyurethanes, silicones, and combinations thereof.

19. The prosthetic heart valve of claim 14, wherein the elastomeric polymer matrix comprises a polymer having a hardness ranging from 75 Shore A to 75 Shore D.

20. A prosthetic heart valve comprising:

an expandable tubular member;

a plurality of leaflets secured together along side 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 tubular seal comprising a polymer matrix and a fabric retained within an inflow end portion of the polymer matrix, wherein the fabric comprises a non-linear edge within the polymer matrix.