LOW-PROFILE HEART VALVE AND DELIVERY SYSTEM

• US 20140324160A1
• Filed: 07/08/2014
• Published: 10/30/2014
• Est. Priority Date: 03/05/2010
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Benichou, Netanel, Rowe, Stanton J., Chow, Sean
• Granted Patent: US 9,901,446 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• 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 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 2250/0059 temporary

Abstract

Disclosed replacement heart valves can be designed to be delivered to a native valve site while crimped on a delivery catheter. The crimped profile of the replacement valve can be minimized by, for example, separating a frame or stent structure from a leaflet structure, along the axial direction. Disclosed replacement valves can be transitioned from a delivery configuration, in which the crimped profile can be minimized, to an operating configuration. The replacement valve can be fully assembled in both the delivery and operating configurations. In some embodiments, the leaflets can be positioned outside of the stent in the delivery configuration, and positioned inside of the stent lumen in the operating configuration. Disclosed replacement valves can include a flexible sleeve coupling the leaflets to the stent and facilitating the transition to the operating configuration. Methods of implanting said replacement valves are also disclosed.

Claims

1. A prosthetic valve, comprising:

a stent portion defining a lumen through said stent portion;

a valve portion comprising one or more leaflets; and

a flexible sleeve coupling the stent portion to the valve portion;

wherein the prosthetic valve is transformable from a delivery configuration in which at least a portion of the one or more leaflets is positioned outside the lumen of the stent portion, to an operating configuration in which at least a portion of the one or more leaflets is positioned within the lumen of the stent portion.

2. The prosthetic valve according to claim 1, wherein a lower portion of the flexible sleeve is positioned within the lumen of the stent portion, and the flexible sleeve extends from the lower portion to an upper portion, wherein the upper portion of the flexible sleeve is positioned adjacent an exterior surface of the valve portion.

3. The prosthetic valve according to claim 1, wherein the valve portion is configured to be pushed or pulled into the lumen of the stent portion, resulting in the flexible sleeve being positioned substantially between an outer surface of the valve portion and an inner surface of the stent portion once the prosthetic valve is transformed to the operating configuration.

4. The prosthetic valve according to claim 1, wherein the one or more leaflets each comprises a free end and a secured end, wherein each of the secured ends is coupled to the flexible sleeve and each of the free ends is freely moveable relative to the flexible sleeve.

5. The prosthetic valve according to claim 4, wherein, in the delivery configuration, the one or more leaflets are arranged such that each of the secured ends is positioned above each of the free ends, and in the operating configuration, the one or more leaflets are arranged such that each of the secured ends is positioned below each of the free ends.

6. The prosthetic valve according to claim 4, wherein the flexible sleeve comprises an inner surface facing the lumen of the stent portion and an outer surface to which the one or more leaflets are coupled while in the delivery configuration, wherein the stent portion comprises a lumen surface defining the lumen of the stent portion and an external surface, and wherein the inner surface of the flexible sleeve is coupled to the external surface of the stent portion.

7. The prosthetic valve according to claim 6, wherein, in the operating configuration, at least a portion of the outer surface of the flexible sleeve is positioned within and facing the lumen of the stent portion.

8. The prosthetic valve according to claim 1, further comprising a temporary valve, wherein the valve portion is coupled to a first end of the stent portion, and the temporary valve is coupled to a second end of the stent portion opposite the first end of the stent portion.

9. The prosthetic valve according to claim 1, wherein the flexible sleeve includes at least one slit through which blood can flow at least when the valve is in the delivery configuration.

10. The prosthetic valve according to claim 1, wherein the stent portion is coupled to the valve portion by one or more hinges configured to allow the one or more leaflets to be inverted from a first position outside the lumen of the stent portion to a second position within the lumen of the stent portion.

11. The prosthetic valve according to claim 1, wherein the flexible sleeve comprises a flexible fabric sleeve.

12. A prosthetic valve, comprising:

a radially collapsible and expandable frame; and

a leaflet structure comprising a plurality of leaflets, a plurality of reinforcement elements, and a plurality of leaflet-supporting members;

wherein the frame is coupled to the leaflet structure such that the leaflets are positioned at least substantially outside of the frame, and wherein a portion of each of the leaflets is positioned in a respective gap formed between a respective reinforcement element and a respective leaflet-supporting member.

13. The prosthetic valve according to claim 12, wherein the frame is coupled to the leaflet structure by a plurality of connecting members.

14. The prosthetic valve according to claim 13, wherein the frame and the connecting members each comprise a plurality of open cells, and wherein each of the leaflet-supporting members is positioned to be a boundary for the plurality of open cells.

15. The prosthetic valve according to claim 12, further comprising a flexible sleeve positioned adjacent at least a portion of the frame.

16. The prosthetic valve according to claim 15, wherein the flexible sleeve is configured to couple the leaflet structure to the frame.

17. The prosthetic valve according to claim 12, wherein at least a portion of each of the leaflet-supporting members is separated from the frame along the axial direction.

18. The prosthetic valve according to claim 12, wherein the prosthetic valve is configured to be transformable from a delivery configuration in which each of the leaflet-supporting members is separated from the frame along the axial direction, to an operating configuration in which a least a portion of each of the leaflet-supporting members is positioned within a lumen of the frame.

19. The prosthetic valve according to claim 12, wherein the leaflet structure is configured to be positioned supraannularly to a native valve annulus.

20. The prosthetic valve according to claim 12, wherein the reinforcement elements are arranged to form a duckbill shape with each pair of adjacent reinforcement elements joined to one another at a commissure point.

21. The prosthetic valve according to claim 12, wherein the frame is coupled to the leaflet structure by at least one sliding rail.

22. The prosthetic valve according to claim 12, wherein the frame is configured to expand to an expanded diameter sufficient to engage a native valve annulus, thereby anchoring the prosthetic valve, and wherein the leaflet structure is configured to expand to a second diameter less than the expanded diameter, so as to not contact the native valve.

23. The prosthetic valve according to claim 12, wherein the frame does not overlap the leaflet structure.

24. A prosthetic heart valve system, comprising:

a delivery apparatus comprising an expansion device and a delivery catheter on which the expansion device is mounted; and

a radially-expandable replacement valve mounted in a radially compressed state on the delivery catheter, wherein the replacement valve comprises a valve portion and a stent portion separated from one another along an axial direction and coupled by at least one pair of sliding rails, the expansion device being configured to expand the replacement valve and to position at least part of the valve portion within a lumen of the stent portion.