Prosthetic heart valve frame with flexible commissures

• US 8,845,720 B2
• Filed: 09/20/2011
• Issued: 09/30/2014
• Est. Priority Date: 09/27/2010
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Conklin, Brian S.
• Primary Examiner(s): Shay, Randy
• Application Number:
  US13/237,556
• Publication Number:
  US 20120078357A1
• Time in Patent Office: 1,106 Days
• Field of Search: 623/2.1, 623 212- 219, 623/2.38
• US Class Current: 623/2.14
• 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 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2433 using balloon catheter
• 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 2250/0036 differing in thickness
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2250/0071 breakable or frangible

Abstract

A prosthetic heart valve can include a valve frame having a wireform portion and a stent portion. The wireform and stent portions can be undetachably coupled together via a plurality of upright struts so as to form a one-piece prosthetic heart valve frame. Alternatively, a self-expanding wireform portion and a balloon-expandable stent portion can be coupled together via one or more leaflets and a subassembly having a flexible leaflet support stent and a sealing ring. The wireform portion can include cusps and commissures configured to support a plurality of leaflets. The prosthetic valve can be radially collapsible for minimally invasive and/or transcatheter delivery techniques. Disclosed embodiments can also provide flexion of the wireform portion (e.g., of the commissures) in response to physiologic pulsatile loading when the valve is implanted in a patient'"'"'s native valve annulus. Methods of making and using prosthetic heart valves are also disclosed.

Claims

1. A prosthetic heart valve that is radially expandable from a compressed configuration to an expanded configuration, comprising:

a balloon-expandable stent portion configured to anchor the prosthetic valve against a heart valve annulus, the stent portion defining a lumen therethrough, wherein the stent portion is radially expandable from a collapsed state to an expanded state, wherein the stent portion has a circumferential strut at an outflow end thereof having an expanded diameter in the expanded state of the stent portion, the stent portion further including an inflow end opposite the outflow end that flares outward from the outflow end in the expanded state of the stent portion;

a plurality of valve leaflets;

a self-expandable wireform portion that is separate from the stent portion, the wireform portion comprising a plurality of commissure supports extending in an outflow direction and the same number of cusps defining an inflow end of the wireform portion, each cusp adapted to support one of the valve leaflets, wherein the wireform portion is radially expandable from a constrained configuration to an expanded configuration where the cusps define an inflow diameter of the wireform portion, the wireform portion having a cloth covering;

a cloth-covered flexible leaflet support stent arranged around the wireform portion and being radially collapsible and expandable along with the wireform portion, the cloth-covered leaflet support stent being attached with sutures to the cloth covering of the wireform portion;

connecting sutures coupling the circumferential strut at the outflow end of the stent portion adjacent to an inflow end of the leaflet support stent such that the expanded diameter of the stent portion is equal to the cusp diameter;

a sealing ring circumscribing and extending outward from the cloth-covered leaflet support stent and from the outflow end of the stent portion, and

wherein the stiffness of the circumferential strut of the stent portion in its collapsed state is sufficient to prevent the inflow end of the wireform portion from expanding toward its expanded configuration by virtue of the outflow end of the stent portion being sutured thereto.

2. The prosthetic heart valve according to claim 1, wherein the leaflet support stent has a plurality of posts aligned with and outside of the commissure supports of the wireform portion, and wherein each valve leaflet is at least partially wrapped around a respective post of the flexible leaflet support stent.

3. The prosthetic heart valve according to claim 2, wherein each leaflet has two opposing tabs, the tabs of adjacent leaflets being configured to be coupled together at a respective commissure support.

4. The prosthetic heart valve according to claim 3, wherein at least a portion of each of the leaflet tabs is wrapped around a post of the flexible leaflet support stent.

5. The prosthetic heart valve according to claim 1, wherein each of the cusps comprises a thinned portion configured to facilitate compression of the wireform portion.

6. The prosthetic heart valve according to claim 1, wherein the stent portion comprises stainless steel, cobalt chromium, or alloys or combinations thereof, and wherein the wireform portion comprises Nitinol, NiTiCr, NiTiCo, or alloys or combinations thereof.

7. The prosthetic heart valve according to claim 1, wherein the stent portion has a series of circular openings at the outflow end thereof through which the sutures pass that couple the stent portion to the inflow end of the combination of the leaflet support stent and wireform portion.

8. The prosthetic heart valve according to claim 1, wherein when the prosthetic valve is in the compressed configuration, at least a portion of the wireform portion overlaps the circumferential strut of the stent portion.

9. The heart valve according to claim 1, wherein the leaflet support stent comprises a continuous stent frame and a plurality of separate commissure tips secured thereto that form support stent commissures.

10. A fully collapsible prosthetic heart valve that is radially expandable from a compressed configuration to an expanded configuration, comprising:

a valve portion comprising a self-expandable wireform portion and a plurality of valve leaflets supported thereby, wherein the valve portion is radially expandable from a constrained state toward an expanded state, the valve portion including a suture-permeable sealing ring disposed around an inflow end of the wireform portion, the inflow end defining an expanded diameter in the expanded state; and

a pre-crimped balloon-expandable stent portion configured to anchor the prosthetic valve against a heart valve annulus, wherein the stent portion is coupled to the valve portion via sutures connected between an outflow end of the stent portion and the inflow end of the wireform portion such that the wireform portion is in its constrained state when the stent portion is in a pre-crimped state and wherein balloon expansion of the stent portion permits expansion of the inflow end of the wireform portion to the same diameter as the stent portion outflow end.

11. The heart valve according to claim 10, wherein the valve portion further comprises a leaflet support stent having commissures to which leaflet tabs attach.

12. The heart valve according to claim 11, wherein the leaflet support stent comprises a continuous stent frame and a plurality of separate commissure tips secured thereto that form the support stent commissures.

13. The heart valve according to claim 10, wherein the stiffness of the stent portion in its pre-crimped state is sufficient to prevent the wireform portion from self-expanding to its expanded state.

14. The prosthetic heart valve according to claim 10, wherein the wireform portion comprises a plurality of commissure supports extending in an outflow direction and the same number of cusps defining an inflow end of the wireform portion, each cusp adapted to support one of the valve leaflets, and wherein each of the cusps comprises a thinned portion configured to facilitate compression of the wireform portion.

15. The prosthetic heart valve according to claim 10, wherein the stent portion has a circumferential strut at an outflow end thereof.

16. The prosthetic heart valve according to claim 15, wherein the stent portion has a series of circular openings at the outflow end thereof through which the sutures pass that connect the stent portion to the inflow end of the wireform portion, the wireform portion having a cloth covering through which the sutures pass.

17. The prosthetic heart valve according to claim 15, wherein when the prosthetic valve is in the compressed configuration, at least a portion of the wireform portion overlaps the circumferential strut of the stent portion.