Prosthetic heart valve square leaflet-leaflet stitch

• US 9,861,477 B2
• Filed: 01/25/2016
• Issued: 01/09/2018
• Est. Priority Date: 01/26/2015
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Backus, Andrew J. H., Lin, John, Kozinn, Shannon Elizabeth
• Primary Examiner(s): Gherbi, Suzette J
• Application Number:
  US15/005,081
• Publication Number:
  US 20160213467A1
• Time in Patent Office: 715 Days
• Field of Search: 623 21- 219
• 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 2220/0008 Fixation appliances for connecting prostheses to the body
• 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 2240/001 Designing or manufacturing processes

Abstract

A prosthetic heart valve provided herein can include at least two leaflets being secured together along aligned edges thereof by a stitch of a single thread. The stitch includes at least one loop extending through a first aperture, around the aligned edges, and back through the first aperture.

Claims

1. A prosthetic heart valve comprising at least two leaflets being secured together along aligned edges thereof by a stitch of a single thread, the stitch comprising at least one loop extending through a first aperture, around the aligned edges, and back through the first apertures;

wherein each leaflet has a body portion and two opposite sleeve portions, the body portion being defined by a bottom edge and two side edges adjacent each sleeve portion, wherein each of the at least two leaflets are aligned and stitched along a first side edge.

2. The prosthetic heart valve of claim 1, wherein the stitch further comprises at least one segment of thread extending from the first aperture to a second aperture in a direction parallel to the aligned edges of the at least two leaflets.

3. The prosthetic heart valve of claim 2, wherein the stitch comprises a second loop extended through the second aperture, around the aligned edges, and back through the second aperture.

4. The prosthetic heart valve of one of claim 1, wherein the stitch comprises at least three loops each extending from an aperture, around the aligned edges, and back to that aperture.

5. The prosthetic heart valve of claim 4, wherein the stitch runs in a forward direction having thread pass through a set of apertures and back in a reverse direction having the thread again pass through the set of apertures.

6. The prosthetic heart valve of claim 5, wherein each aperture has two loops extending from that aperture, around the aligned edges, and tack to that aperture, wherein one loop is from the stitch running in the forward direction and one loop is from the stitch running in the reverse direction.

7. The prosthetic heart valve of claim 5, wherein segments of thread extending between adjacent apertures in the forward direction are on an opposite side of the two leaflets from the segments of thread extending between adjacent apertures in the reverse direction.

8. The prosthetic heart valve of claim 1, wherein the leaflets define notches between the two side edges and the adjacent sleeve portion.

9. The prosthetic heart valve of claim 1, wherein the stitch runs along a side edge from a bottom edge to a notch.

10. The prosthetic heart valve of claim 1, further comprising a plurality of support element each supporting sleeve portions each leaflet along a line approximately aligned the stitch.

11. A prosthetic heart valve comprising:

at least three leaflets secured together along side edges thereof by a stitch of a single thread;

a tubular expandable member secured to an out flow end of the at least three leaflets; and

a tubular seal secured to an inflow end bottom edge of the at least three leaflets and to an outer surface of the tubular expandable member;

wherein the stitch is formed using between 3 and 20 apertures and includes between 3 and 40 loops each extending from an aperture, around the aligned side edges, and back to that aperture.

12. The prosthetic heart valve of claim 11, wherein the tubular expandable member is a braided stent and wherein tubular seal is secured to the braided stent by a plurality of cross stitches connecting the tubular seal to a pair of overlapping wire members of the braided stent.

13. The prosthetic heart valve of claim 11, wherein the tubular seal comprises a woven fabric and the at least three leaflets are secured to the tubular seal in a portion of the tubular seal comprising the woven fabric.

14. The prosthetic heart valve of claim 13, wherein the woven fabric can have a thickness range from about 40 to about 80 microns.

15. The prosthetic heart valve of claim 13, wherein the woven fabric is disposed within a polymer matrix.

16. The prosthetic heart valve of claim 11, wherein the at least one leaflet comprises bovine or porcine pericardium tissue or a synthetic material.

17. The prosthetic heart valve of claim 11, wherein one or more stitches can be repeated at a plurality of intersections circumferentially around the inflow end bottom edge.

18. A prosthetic heart valve comprising:

at least three leaflets secured together along side edges thereof by a stitch of a single thread, at least one leaflet being secured to at least a second leaflet by a running stitch, the running stitch being a square stitch;

a tubular expandable member secured to an out flow end of the at least three leaflets; and

a tubular seal secured to an inflow end bottom edge of the at least three leaflets and to an outer surface of the tubular expandable member.