Axially anchoring collapsible and re-expandable prosthetic heart valves for various disease states

• US 9,226,820 B2
• Filed: 07/15/2009
• Issued: 01/05/2016
• Est. Priority Date: 07/15/2008
• Status: Active Grant

• Current Assignee: St. Jude Medical (Abbott Laboratories Incorporated)
• Original Assignee: St Jude Medical Incorporated (Abbott Laboratories Incorporated)
• Inventors: Braido, Peter N., Neuman, Julia A., Benson, Thomas M.
• Primary Examiner(s): Sharma, Yashita
• Assistant Examiner(s): SHIPMON, TIFFANY P
• Application Number:
  US12/737,254
• Publication Number:
  US 20110098800A1
• Time in Patent Office: 2,365 Days
• Field of Search: 623/1.12, 623/1.15, 623/1.16, 623/2.1, 623/2.14, 623 217- 219
• US Class Current: 1/1
• 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 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• 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 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/008 paraboloidal

Abstract

A stent (10) for use in a prosthetic heart valve has an annulus section (12) adapted for placement within the ′ leaflets and annulus of the native heart valve. The annulus section has latch members (50) adapted to engage the leaflets of the native heart valve when prosthetic valve is implanted in the native valve. The latch members may hold the leaflets in engagement with the annulus section, and help to retain the prosthetic valve in position. The annulus section may have a non-circular cross-sectional shape.

Claims

1. A stent for use with a prosthetic heart valve for replacement of a native heart valve comprising an expandable non-woven stent body having a collapsed configuration and an expanded configuration, the stent body including an annulus section adjacent a proximal end of the stent, the annulus section including a plurality of closed cells arranged in a multiplicity of annular rows around a circumference of the stent body, the annulus section in the expanded configuration being generally tubular and adapted to engage the leaflets of the native heart valve and the annulus of the native heart valve with a proximal end of the annulus section adjacent the annulus of the native valve and a distal end of the annulus section adjacent distal ends of the native leaflets, the stent body including a plurality of latch members formed integrally with the annulus section, each of the latch members including a pair of connection struts and an engagement portion adapted to engage an exterior surface of a leaflet of the native valve, the connection struts being connected to the stent body at circumferentially-spaced locations in the annulus section and projecting distally from the locations to distal ends located distal to the annulus section, and the engagement portion being connected to the connection struts adjacent the distal ends thereof and projecting proximally from the distal ends of the connection struts to an engagement portion proximal end unconnected to other structure, each of the engagement portions being spaced from a next adjacent engagement portion around the circumference of the stent.

2. A stent as claimed in claim 1 wherein, in the expanded configuration, the engagement portion slopes outwardly in the proximal direction.

3. A stent as claimed in claim 1 wherein the engagement portion includes a pair of engagement struts connected to the connection struts adjacent the distal ends thereof and projecting proximally from the distal ends of the connection struts, the engagement struts being connected to one another adjacent proximal ends thereof.

4. A stent as claimed in claim 3 wherein the at least one row of expandable cells includes a plurality of interconnected cell struts joining one another at crests and defining the cells, the crests including a distal row of crests at the distal end of the annulus section, the connection struts being connected to the crests of the distal row.

5. A stent as claimed in claim 4 wherein the connection struts of the latch member are connected to the crests of the distal row that are not mutually adjacent to one another.

6. A stent as claimed in claim 3 wherein the engagement struts of the latch member project toward one another in circumferential directions.

7. A stent as claimed in claim 3 wherein the latch member includes a proximal end member extending between the proximal ends of the engagement struts.

8. A stent as claimed in claim 7 wherein the proximal end member is generally arcuate.

9. A stent as claimed in claim 8 wherein the proximal end member includes a bight projecting distally from the proximal ends of the engagement struts.

10. The stent of claim 1 wherein the annulus section includes a plurality of rows of the extendable cells.

11. The stent of claim 1 wherein the at least one latch member includes a plurality of the latch members circumferentially spaced around the annulus section.

12. The stent of claim 1 wherein the annulus section includes a plurality of commissure posts circumferentially spaced from one another.

22. A valve comprising a stent as claimed in any of the preceding claims and a plurality of flexible prosthetic valve leaflets disposed at least partially within the annulus section when the stent is in the expanded configuration.

23. A method of treating a patient comprising implanting a valve as claimed in claim 22 in a native valve of the patient so that one or more leaflets of the native valve are engaged by the annulus section of the stent body and by one or more latch members of the stent body.

13. A stent for use with a prosthetic heart valve for replacement of a native aortic valve, the stent comprising an expandable stent body having an expanded configuration including a generally tubular annulus section extending in proximal and distal directions, a generally tubular aorta section of larger diameter than the annulus section, the aorta section being spaced distally from the annulus section, and a plurality of support struts spaced circumferentially from one another and interconnecting the annulus section with the aorta section, the annulus section including a plurality of closed cells arranged in a multiplicity of annular rows around a circumference of the stent body, the stent body further including at least one latch member connected to the stent body adjacent the annulus section, the latch member including a pair of connection struts and an engagement portion disposed outward of the annulus section in the expanded configuration, the connection struts being connected to the stent body at circumferentially-spaced locations in the annulus section and projecting distally from the locations to distal ends located distal to the annulus section, and the engagement portion being connected to the connection struts adjacent the distal ends thereof and projecting proximally from the distal ends of the connection struts, the stent body being adapted for disposition with the annulus section adjacent the annulus of the native valve and at least partially within the leaflets of the native valve, the aortic section adjacent the native sinotubular junction and the support struts extending at least partially across the native Valsalva sinus, and with the engagement portion of at least one latch member engaged with at least one native valve leaflet.

14. The stent of claim 13 wherein the stent body is cut from a metal tube.

15. The stent of claim 13 wherein the annulus section includes a plurality of commissure posts spaced circumferentially from one another.

16. The stent of claim 15 wherein the plurality of support struts includes a group of support struts associated with each of the commissure posts, the support struts in the group being disposed circumferentially adjacent the commissure post associated with the group.

17. The stent of claim 16 wherein the latch member is offset circumferentially from the commissure posts and from the support struts.

18. The stent of claim 17 wherein the stent body has a collapsed configuration and wherein, in the collapsed configuration, the latch member extends distally from the annulus section between the support struts associated with different commissure posts.

19. The stent of claim 18 wherein the annulus section comprises one or more rows of expandable cells and the aorta section comprises one or more rows of expandable cells.

20. The stent of claim 13 including three of the latch members equally spaced circumferentially around the annulus section.

21. The stent of claim 20 wherein the annulus section includes three commissure posts equally spaced circumferentially around the annulus section alternating with the three latch members.

24. A stent for use with a prosthetic heart valve for replacement of a native valve, comprising:

an expandable stent body having an expanded configuration including an annulus section having a plurality of cell struts joined to one another to form a plural number of closed cells cooperatively defining a generally tubular wall extending circumferentially around a proximal-to-distal axis, each of the cells having a distal cell crest, the distal cell crests of the cells in a most distal row of cells in the annulus section collectively defining a scalloped distal edge of the tubular wall including a number of circumferentially-spaced recess regions and a number of circumferentially-spaced projections extending distally beyond the recess regions, the projections being interspersed with the recess regions around the circumference of the tubular wall, each of the projections including a plurality of the distal cell crests and each of the recess regions including a plurality of the distal cell crests.

25. A valve comprising a stent as claimed in claim 24 and a plurality of flexible prosthetic valve leaflets having free edges and base edges, the leaflets being disposed at least partially within the annulus section when the stent is in the expanded configuration and being adapted to coapt with one another along the free edges, the free edges of the leaflets being connected to the annulus section at commissure locations circumferentially aligned with the recess regions of the wall.