Spiraled commissure attachment for prosthetic valve

• US 8,568,475 B2
• Filed: 10/05/2011
• Issued: 10/29/2013
• Est. Priority Date: 10/05/2010
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Nguyen, Son V., Benichou, Netanel
• Primary Examiner(s): Isabella, David
• Assistant Examiner(s): SHAY, RANDY CITRIN
• Application Number:
  US13/253,698
• Publication Number:
  US 20120089223A1
• Time in Patent Office: 755 Days
• Field of Search: 623/2.1, 623 211- 219
• US Class Current: 623/2.12
• 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 2220/0091 connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
• CPC Class Codes: A61F 2230/0054 V-shaped

Abstract

An implantable prosthetic valve, according to one embodiment, comprises a radially collapsible and expandable frame and a leaflet structure supported within the frame. The leaflet structure can comprise a plurality of leaflets paired together at commissures. In one embodiment, the commissures can comprise leaflet tabs rolled into spirals around non-rigid reinforcing inserts. In another embodiment, the commissures can comprise a reinforcing sheet folded around leaflet tabs.

Claims

1. An implantable prosthetic valve, comprising:

a radially collapsible and expandable annular frame;

an annular skirt coupled to an inner side of the frame;

a leaflet structure positioned within the frame and the annular skirt and comprising a plurality of leaflets each comprising two opposing side tabs, wherein each leaflet comprises a separate piece of material, wherein each side tab is rolled into a spiral and each spiral is positioned next to an adjacent spiral of an adjacent leaflet to form a plurality of annularly spaced commissures of the leaflet structure, and wherein each spiral is coupled to the annular skirt;

wherein the side tab of each spiral is rolled around a central longitudinal axis of the spiral greater than 360 degrees such that at least two layers of the side tab are in contact with each other;

wherein the skirt comprises a single sheet of material that extends continuously around the leaflet structure, and each leaflet has an inflow end portion that is sutured to the skirt by a suture line that extends along the inflow end portion of each leaflet.

2. The valve of claim 1, wherein each spiral comprises a non-rigid reinforcing material that reinforces the spirals to resist suture tear-through.

3. The valve of claim 2, wherein the reinforcing material comprises a plurality of inserts, at least one insert being positioned within each spiral.

4. The valve of claim 3, wherein for each spiral, at least one suture intersects at least three layers of the respective side tab and the at least one insert within the spiral.

5. The valve of claim 3, wherein for each spiral, stitches of at least one suture intersect at least:

a first two layers of the spiral, an insert within the spiral, a second two layers of the spiral, and the skirt, in that order.

6. The valve of claim 3, wherein the inserts are tubular and comprise a compressible material and are retained in a compressed state by sutures extending radially through the spirals.

7. The valve of claim 3, wherein each spiral is sutured to the skirt with a respective suture that intersects the spiral, the reinforcing insert, and the skirt.

8. The valve of claim 1, wherein for each spiral, at least one suture intersects at least four different layers of the respective side tab.

9. The valve of claim 1, wherein for each spiral, at least one suture extending in a generally radial direction secures the spiral to the skirt.

10. The valve of claim 1, wherein each spiral provides a curved, cushioned surface for a flex hinge portion of the respective leaflet to bear against as the leaflet articulates between an open and a closed position.

11. The valve of claim 1, wherein each leaflet comprises an articulation portion extending between the two spirals of each leaflet and the spirals provide a radial clearance between the frame and articulation portions of the leaflets.

12. The valve of claim 1, wherein each leaflet comprises an articulation portion extending between the two spirals of each leaflet, and the two spirals of each commissure are secured to the skirt with sutures spaced away from the articulation portions of the leaflets.

13. The valve of claim 1, wherein the leaflets comprise bovine pericardium tissue harvested from one or more calves less than about four weeks of age.

14. The valve of claim 13, wherein the tissue is harvested from calves between about one week and about two weeks of age.

15. The valve of claim 1, wherein the two spirals of each commissure are not sutured together.

16. An implantable prosthetic valve, comprising:

a radially collapsible and expandable annular frame; and

a leaflet structure positioned within the frame and comprising a plurality of leaflets each comprising two opposing side tabs, wherein each leaflet comprises a separate piece of material, wherein each side tab is rolled into a spiral and each spiral is positioned next to an adjacent spiral of an adjacent leaflet to form a plurality of annularly spaced commissures of the leaflet structure;

wherein the side tab of each spiral is rolled around a central longitudinal axis of the spiral greater than 360 degrees such that at least two layers of the side tab are in contact with each other.

17. The valve of claim 16, wherein the two spirals of each commissure are not sutured together.

18. The valve of claim 17, wherein the two spirals of each commissure are sutured radially outwardly to an annular skirt such that the two spirals of each commissure are held against each other.

19. The valve of claim 16, wherein each spiral comprises a non-rigid reinforcing material that reinforces the spirals to resist suture tear-through.