Prosthetic Heart Valve Frame With Flexible Commissures

• US 20120078357A1
• Filed: 09/20/2011
• Published: 03/29/2012
• Est. Priority Date: 09/27/2010
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Conklin, Brian S.
• Granted Patent: US 8,845,720 B2
• Time in Patent Office: Days
• US Class Current: 623/2.18
• 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 frame that is radially expandable from a compressed configuration to an expanded configuration, comprising:

a stent portion adapted to anchor against a heart valve annulus, the stent portion defining a lumen therethrough; and

a wireform portion adapted to support at least one valve leaflet, wherein when the prosthetic valve frame is in the compressed configuration, at least a portion of the wireform portion is positioned within the lumen defined by the stent portion, and wherein at least a part of the wireform portion is configured to undergo flexion during pulsatile loading.

2. The prosthetic heart valve frame according to claim 1, wherein the wireform portion comprises a plurality of cusps configured to engage with a respective valve leaflet and wherein each of the cusps comprises a thinned portion configured to facilitate compression of the wireform portion.

3. The prosthetic heart valve frame according to claim 2, wherein in the compressed configuration, at least a portion of the cusps are positioned inside the lumen of the stent portion.

4. The prosthetic heart valve frame according to claim 3, wherein in the expanded configuration, the cusps are configured to be spaced apart from the stent portion along a longitudinal direction defined by the lumen of the stent portion.

5. The prosthetic heart valve frame according to claim 2, wherein the stent portion comprises a plurality of upright struts spaced around the circumference of the stent portion, the upright struts extending towards an outflow end of the wireform portion and configured to couple the wireform portion to the stent portion.

6. The prosthetic heart valve frame according to claim 5, wherein the upright struts extend to a T-shaped termination positioned along a respective commissure support.

7. The prosthetic heart valve frame according to claim 5, wherein adjacent cusps are coupled to one another at each of the upright struts so as to form a commissure support at each upright strut.

8. The prosthetic heart valve frame according to claim 7, in combination with a plurality of leaflets each having two opposing tabs, the tabs of adjacent leaflets being configured to be coupled together at a respective commissure support.

9. The prosthetic heart valve frame according to claim 8, wherein at least a portion of each of the leaflet tabs is wrapped around an upright strut.

10. The prosthetic heart valve frame according to claim 1, wherein an inflow end of the stent portion is flared outward in the expanded configuration, the inflow end being opposite the wireform portion.

11. The prosthetic heart valve frame according to claim 1, in combination with a sealing ring coupled to the wireform portion, the sealing ring being configured to be positioned supraannularly.

12. A radially collapsible and expandable prosthetic heart valve, comprising:

a stent portion configured to anchor the prosthetic heart valve to a patient'"'"'s native valve;

a leaflet-supporting structure spaced axially from the stent portion, the leaflet-supporting structure comprising a continuous ring defining a plurality of leaflet-supporting cusps and a plurality of commissure supports, the commissure supports being positioned between adjacent leaflet-supporting cusps, wherein the commissure supports are configured to undergo cantilevered motion under physiologic loading; and

a plurality of connecting segments spaced apart from one another, each connecting segment extending axially from a first end of the stent portion adjacent the leaflet-supporting structure to a leaflet-supporting cusp.

13. The radially collapsible and expandable prosthetic heart valve according to claim 12, wherein the stent portion and the leaflet-supporting structure are undetachably coupled to one another to form a one-piece prosthetic heart valve.

14. The radially collapsible and expandable prosthetic heart valve according to claim 12, in combination with a plurality of leaflets, each leaflet being coupled to a respective leaflet-supporting cusp by suturing to a cloth covering surrounding the leaflet-supporting cusps and the commissure supports, wherein the leaflets are configured such that a central hole through the leaflets remains open when the prosthetic heart valve is at rest.

15. The radially collapsible and expandable prosthetic heart valve according to claim 14, in combination with a sealing ring coupled to the leaflet-supporting structure, the sealing ring being configured to be positioned supraannularly.

16. A method of implanting a prosthetic heart valve, comprising:

radially compressing a prosthetic heart valve to a compressed configuration, wherein the prosthetic heart valve comprises a stent portion configured to anchor the prosthetic heart valve to a patient'"'"'s native valve and a leaflet-supporting structure;

delivering the compressed prosthetic heart valve to or near a patient'"'"'s native valve annulus;

positioning the leaflet-supporting structure of the prosthetic heart valve supraannularly to a patient'"'"'s aortic valve; and

expanding the prosthetic heart valve to an expanded configuration, wherein the diameter of the prosthetic heart valve in the expanded configuration is greater than the diameter of the prosthetic heart valve in the compressed configuration, and wherein in the compressed configuration at least a portion of the leaflet-supporting structure is positioned within a lumen of the stent portion, and in the expanded configuration the leaflet-supporting structure is positioned externally to the lumen of the stent portion.

17. The method according to claim 16, wherein the prosthetic heart valve includes a one-piece prosthetic heart valve frame.

18. The method according to claim 17, wherein expanding the prosthetic heart valve effectively anchors the prosthetic heart valve without suturing the valve to the native valve.

19. 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; and

a self-expandable wireform portion that is separate from the stent portion, the wireform portion comprising at least one commissure support and at least one cusp adapted to support at least one valve leaflet, wherein the wireform portion is radially expandable from a constrained configuration to a stress-free configuration, and wherein the stiffness of the stent portion in its collapsed state is sufficient to prevent the wireform portion from expanding to its stress-free configuration.

20. The prosthetic heart valve according to claim 19, further comprising a flexible leaflet support stent coupled to the wireform portion.

21. The prosthetic heart valve according to claim 20, further comprising a sealing ring coupled to the flexible leaflet support stent and to the stent portion, wherein the sealing ring is configured to be positioned supraannularly.

22. The prosthetic heart valve according to claim 21, wherein the at least one valve leaflet is at least partially wrapped around a respective post of the flexible leaflet support stent and the sealing ring is sutured to a plurality of circular openings on the stent portion.

23. The prosthetic heart valve according to claim 19, wherein the wireform portion comprises three cusps configured to engage with a respective valve leaflet, and wherein each of the cusps comprises a thinned portion configured to facilitate compression of the wireform portion.

24. The prosthetic heart valve according to claim 20, wherein the at least one valve leaflet comprises a plurality of leaflets each having two opposing tabs, the tabs of adjacent leaflets being configured to be coupled together at a respective commissure support.

25. The prosthetic heart valve according to claim 24, wherein at least a portion of each of the leaflet tabs is wrapped around a post of a flexible leaflet support stent.

26. The prosthetic heart valve according to claim 19, 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.

27. 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 at least one valve leaflet, wherein the valve portion is radially expandable from a constrained state to an 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 one or more non-metallic components.

28. The heart valve according to claim 27, wherein the valve portion further comprises a leaflet support stent and a sealing ring.

29. The heart valve according to claim 27, 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.

30. The heart valve according to claim 27, wherein the one or more non-metallic components comprise a cloth-covered leaflet support stent and/or a sealing ring.