Prosthetic heart valve having tubular seal

• US 9,788,942 B2
• Filed: 01/27/2016
• Issued: 10/17/2017
• 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: Backus, Andrew J. H., Noe, Spencer C., Miracle, Christopher M.
• Primary Examiner(s): Gherbi, Suzette J
• Application Number:
  US15/007,979
• Publication Number:
  US 20160220365A1
• Time in Patent Office: 629 Days
• Field of Search: 623 115- 153
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• 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 2250/0069 Sealing means

Abstract

A prosthetic heart valve includes a plurality of leaflets and an expandable member including one or more braided wires with a first set of wire segments extended helically in a first direction and a second set of wire segments extended helically in a second direction such that each wire segment of the first set intersects a plurality of wire segments from the second set at a plurality of intersection points. The one or more braided wires can have crowns where the wire segments of the first set connect to wire segments of the second set. The heart valve can include a tubular seal secured to the plurality of leaflets and to the expandable member by a plurality of sutures. The sutures can include cross stitches formed around both a wire segment of the first set and a wire segment of the second set at one of the intersection points.

Claims

1. A prosthetic heart valve comprising:

an expandable member comprising one or more braided wires, the one or more braided wires comprising a first set of wire segments extended helically in a first direction and a second set of wire segments extended helically in a second direction such that each wire segment of the first set intersects a plurality of wire segments from the second set at a plurality of intersection points, wherein the one or more braided wires have crowns where the wire segments of the first set connect to wire segments of the second set;

a plurality of leaflets being secured within the expandable member; and

a tubular seal comprising an elastomeric material, the tubular seal having an inflow edge being secured to bottom inflow edges of the plurality of leaflets and to the expandable member by a plurality of sutures, characterized by the sutures comprising cross stitches formed around both a wire segment of the first set and a wire segment of the second set at one of the intersection points.

2. The prosthetic heart valve of claim 1, wherein each cross stitch is an independently tied off stitch unconnected to other cross stitches.

3. The prosthetic heart valve of claim 1, wherein each cross stitch is attached at an intersection point immediately adjacent a crown at an inflow side of the expandable member.

4. The prosthetic heart valve of claim 1, wherein the plurality of leaflets are secured together along side edges thereof.

5. The prosthetic heart valve of claim 4, wherein the plurality of leaflets each comprise two sleeve portions, wherein the sleeve portions are secured to the expandable member by a plurality of anchor elements.

6. The prosthetic heart valve of claim 1, wherein the tubular seal comprises a plurality of non-elastic fibers retained within a matrix of the elastomeric material, the non-elastic fibers being arranged to allow the tubular seal to stretch in an axial or a radial direction.

7. The prosthetic heart valve of claim 6, wherein the non-elastic fibers are part of a fabric.

8. The prosthetic heart valve of claim 7, wherein the fabric has a thickness ranging from about 40 to about 80 microns.

9. The prosthetic heart valve of claim 7, wherein the fabric is a woven fabric.

10. The prosthetic heart valve of claim 9, 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.

11. The prosthetic heart valve of claim 10, wherein the fibers in both the warp direction and the waft direct are angled at an angle between 5 degrees and 70 degrees with respect to the central axis of the tubular seal.

12. The prosthetic heart valve of claim 7, wherein the fibers are made of polyester.

13. The prosthetic heart valve of claim 6, wherein the non-elastic fibers are uniformly dispersed throughout the matrix.

14. The prosthetic heart valve of claim 1, wherein the tubular seal has a substantially uniform thickness.

15. A prosthetic heart valve comprising:

an expandable member comprising one or more braided wires, the one or more braided wires comprising a first set of wire segments and a second set of wire segments such that each wire segment of the first set intersects a plurality of wire segments from the second set at a plurality of intersection points;

a plurality of leaflets being secured within the expandable member; and

a tubular seal comprising an elastomeric material, the tubular seal having an inflow edge being secured to bottom inflow edges of the plurality of leaflets and to the expandable member by a plurality of sutures, wherein the sutures comprise cross stitches formed around both a wire segment of the first set and a wire segment of the second set at one of the intersection points;

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 a fabric within a matrix of an elastomeric matrix, wherein the fabric has a non-linear edge defining an interface between the inflow end region and the outflow end region.

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

17. The prosthetic heart valve of claim 15, wherein the plurality of leaflets are secured to the tubular seal by a continuous circumferential running stitch.

18. The prosthetic heart valve of claim 15, wherein the first set of wire segments extends helically in a first direction and a second set of wire segments extends helically in a second direction.

19. The prosthetic heart valve of claim 18, wherein the one or more braided wires have crowns where the wire segments of the first set connect to wire segments of the second set.