BAR-LESS COMMISSURE ATTACHMENT FOR PROSTHETIC VALVE

• US 20120089223A1
• Filed: 10/05/2011
• Published: 04/12/2012
• 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
• Granted Patent: US 8,568,475 B2
• Time in Patent Office: Days
• US Class Current: 623/2.14
• 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 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; and

a leaflet structure positioned within the frame and comprising a plurality of leaflets each comprising two opposing side tabs, wherein each side tab is rolled into a spiral and each spiral is coupled to an adjacent spiral of an adjacent leaflet to form a plurality of annularly spaced commissures of the leaflet structure, and wherein each commissure is coupled the frame.

2. The valve of claim 1, wherein each spiral comprises a non-rigid reinforcing material and the two spirals of each commissure are sutured to one another such that the reinforcing material 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 commissure at least one suture intersects at least three layers of each side tab and the at least one insert within each spiral.

5. The valve of claim 1, wherein for each commissure at least one suture intersects at least three different layers of each side tab.

6. The valve of claim 1, wherein for each commissure at least one suture intersects at least four different layers of each side tab.

7. The valve of claim 3, wherein stitches of at least one suture intersect at least:

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

8. 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 through the spirals.

9. The valve of claim 1, further comprising:

an annular skirt secured between the leaflet structure and the frame; and

non-rigid reinforcing inserts positioned within each spiral, wherein each spiral is sutured to the skirt with a respective suture that intersects at least three portions of the spiral, the reinforcing insert, and 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 one another 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. An implantable prosthetic valve, comprising:

a radially collapsible and expandable annular frame; and

a valve structure positioned within the frame and comprising a plurality of leaflets and a plurality of flexible reinforcing sheets, each leaflet comprising two opposing side tabs, each side tab being secured to an adjacent side tab of another leaflet and to one of the reinforcing sheets to form a plurality of annularly spaced reinforced commissures of the valve structure, each commissure being coupled to the frame;

wherein each side tab comprises a medial portion and an end portion extending from the medial portion, the medial portion being in contact with the medial portion of the adjacent side tab, and the end portion being folded back away from the adjacent side tab and adjacent to the medial portion; and

wherein each sheet comprises a middle portion extending circumferentially between the side tabs and the frame, first and second side portions extending radially inwardly from respective opposing ends of the middle portion of the sheet and around the end portions of the respective side tabs, and first and second end portions extending radially outwardly from radially inner ends of the first and second side portions of the sheet, respectively, each end portion of the sheet being sandwiched between the medial portion and the end portion of a respective side tab.

16. The valve of claim 15, wherein each commissure is secured together by at least one suture that intersects the medial portions and the end portions of both side tabs and at least four layers of the sheet.

17. The valve of claim 16, wherein stitches of the suture intersects at least:

the first side portion of the sheet, the end portion of a first side tab, the first end portion of the sheet, the medial portion of the first side tab, the medial portion of a second side tab, the second end portion of the sheet, the end portion of the second side tab, and the second side portion of the sheet, in that order.

18. The valve of claim 15, further comprising an annular skirt secured between the leaflet structure and the frame, wherein each side tab is independently sutured to the skirt with respective sutures that intersects multiple portions of the respective side tab, multiple portions of the reinforcing sheet, and the skirt.

19. The valve of claim 15, wherein the leaflets further comprise flex hinges adjacent to the commissures, and the commissures provide curved and cushioned surfaces for the flex hinges to bear against as the leaflets articulate between an open and a closed position.

20. The valve of claim 15, wherein the leaflets further comprise articulation portions between the commissures and the commissures provide a radial clearance between the frame and articulation portions.

21. The valve of claim 15, wherein each leaflet comprises an articulation portion between the two side tabs of the leaflet, and sutures securing the commissures together are spaced away from the articulation portions of the leaflets.

22. The valve of claim 15, wherein the sheets substantially envelope the side tabs.

23. The valve of claim 18, wherein the commissures are secured to the skirt with sutures comprising stitches that extend generally in the direction of the radius of the frame.