Replacement heart valve prosthesis

• US 10,350,062 B2
• Filed: 07/18/2017
• Issued: 07/16/2019
• Est. Priority Date: 07/21/2016
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Peterson, Matthew A., Yi, Seung-Beom, Vad, Siddharth, Oba, Travis Zenyo, Freschauf, Lauren R., French, Amanda, Keidar, Yaron, Du, Yuanlong, Bak-Boychuk, Gregory, Golemo, Kevin M., Cooper, Alexander H.
• Primary Examiner(s): Stewart, Alvin J
• Application Number:
  US15/653,390
• Publication Number:
  US 20180021129A1
• Time in Patent Office: 728 Days
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• 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 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/0014 having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0036 differing in thickness
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0063 Nested prosthetic parts
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

A prosthesis can be configured to grasp intralumenal tissue when deployed within a body cavity and prevent axial flow of fluid around an exterior of the prosthesis. The prosthesis can include an expandable frame configured to radially expand and contract for deployment within the body cavity and a valve body. The expandable frame can include a frame body and a supplemental frame. The valve body can include a plurality of leaflets and one or more intermediate components. The one or more intermediate components can couple at least a portion of the leaflets to the expandable frame. The prosthesis can include an annular flap positioned around an exterior of the expandable frame.

Claims

1. A replacement heart valve prosthesis for deployment at a native heart valve, the prosthesis comprising:

an expandable frame configured to radially expand and contract for deployment within a native heart valve, the expandable frame comprising;

a frame body comprising a proximal region, a distal region, and an intermediate region extending between the proximal and distal regions, the frame body comprising a first row of struts and a second row of struts;

a supplemental frame comprising a first row of struts configured to be generally aligned along the first row of struts of the frame body, the first row of struts of the supplemental frame having a shape which generally matches the shape of the first row of struts of the frame body;

a proximal anchoring feature, the proximal anchoring feature sized to be positioned on a first side of an annulus of the native heart valve; and

a distal anchoring feature, the distal anchoring feature sized to be positioned on a second side of an annulus of the native heart valve; and

a valve body positioned within an interior of the expandable frame, the valve body comprising a plurality of leaflets configured to allow flow in a first direction and prevent flow in a second opposite direction;

wherein the plurality of leaflets each have an arcuate proximal edge and a free distal edge, the plurality of leaflets being joined at commissures, the plurality of leaflets configured to allow flow in a proximal-to-distal direction and prevent flow in a distal-to-proximal direction; and

wherein the valve body comprises one or more intermediate components connecting the leaflets to the expandable frame, wherein at least a portion of the arcuate proximal edge of each leaflet and/or the commissures are indirectly coupled to the expandable frame via the one or more intermediate components such that when the frame is in an expanded configuration, the one or more intermediate components position at least a portion of the arcuate proximal edge of each leaflet and/or the commissures radially inward from an inner surface of the expandable frame.

2. The prosthesis of claim 1, wherein the supplemental frame is formed separately from the frame body and the first row of struts of the supplemental frame is configured to be attached to at least a portion of the first row of struts of the frame body.

3. The prosthesis of claim 2, wherein the first row of struts of the supplemental frame is attached to the first row of struts of the frame body via sutures.

4. The prosthesis of claim 1, wherein the first row of struts of the supplemental frame is configured to be positioned radially inwardly of the first row of struts of the frame body.

5. The prosthesis of claim 1, wherein the first row of struts of the supplemental frame is configured to be positioned radially outwardly of the first row of struts of the frame body.

6. The prosthesis of claim 1, wherein the distal anchoring feature extends distally from the frame body and the supplemental frame comprises a second row of struts extending distally of the frame body, the first and second rows of struts of the supplemental frame forming cells.

7. The prosthesis of claim 1, wherein the proximal anchoring feature comprises a first row of struts configured to be generally aligned along the second row of struts of the frame body, the first row of struts of the proximal anchoring feature having a shape which generally matches the shape of the second row of struts of the frame body.

8. The prosthesis of claim 7, wherein the proximal anchoring feature is formed separately from the frame body and the first row of struts of the proximal anchoring feature is configured to be attached to at least a portion of the second row of struts of the frame body.

9. The prosthesis of claim 8, wherein the first row of struts of the proximal anchoring feature is attached to the second row of struts of the frame body via sutures.

10. The prosthesis of claim 7, wherein the first row of struts of the proximal anchoring feature is configured to be positioned radially outwardly of the second row of struts of the frame body.

11. The prosthesis of claim 7, wherein the proximal anchoring feature comprises a second row of struts configured to be generally aligned along a third row of struts of the frame body, the second row of struts of the proximal anchoring feature having a shape which generally matches the shape of the third row of struts of the frame body, the first and second rows of struts of the proximal anchoring feature forming cells.

12. The prosthesis of claim 1, further comprising a plurality of locking tabs extending from at least one of the frame body and the proximal anchoring feature.

13. The prosthesis of claim 12, wherein at least some of the locking tabs extend from the frame body and at least some of the locking tabs extend from the proximal anchoring feature, wherein the locking tabs of the proximal anchoring feature are configured to be generally aligned along the locking tabs of the frame body, the locking tabs of the proximal anchoring feature having a shape which generally matches the shape of the locking tabs of the frame body.

14. The prosthesis of claim 1, wherein the distal anchoring feature comprises a plurality of distal anchors, at least one of the distal anchors comprising two or more prongs.

15. The prosthesis of claim 14, wherein the two or more prongs are movable in at least one of a lateral direction and a radial direction relative to each other.

16. The prosthesis of claim 1, wherein the distal anchoring feature comprises one or more anchors configured to be movable in an axial direction relative to the frame body.

17. The prosthesis of claim 1, wherein the distal anchoring feature comprises one or more anchors having an insert comprising a platform, the platform configured to extend radially and laterally outwardly relative to the distal anchor when the expandable frame is in an expanded configuration.

18. The prosthesis of claim 1, wherein the one or more intermediate components form a generally tangent surface with the expandable frame when the valve body is closed to prevent flow in the second direction.

19. The prosthesis of claim 1, wherein the one or more intermediate components form an angle between about 120°

to about 195°

with the expandable frame when the valve body is closed to prevent flow in the second direction.

20. The prosthesis of claim 1, wherein the one or more intermediate components is formed from a material having a stiffness greater than that of the plurality of leaflets and less than that of the expandable frame.

21. The prosthesis of claim 1, wherein:

the prosthesis comprises an annular skirt extending around the exterior of the expandable frame; and

at least one of the valve body and the annular skirt comprises one or more openings configured to allow at least one of;

fluid ingress into a space between the valve leaflets and the annular skirt; and

fluid egress out of the space between the valve leaflets and the annular skirt.

22. The prosthesis of claim 21, wherein:

the annular skirt comprises a supplemental rib extending from a portion of the annular skirt; and

the annular skirt extends to different radial dimensions with a first peripheral region extending to a first radial dimension and a second peripheral region extending to a second radial dimension greater than the first radial dimension.

23. A replacement heart valve prosthesis for deployment at a native heart valve, the prosthesis comprising:

an expandable frame configured to radially expand and contract for deployment within a native heart valve, the expandable frame comprising;

a frame body comprising a proximal region, a distal region, and an intermediate region extending between the proximal and distal regions, the frame body comprising a first row of struts and a second row of struts;

a supplemental frame comprising a first row of struts configured to be generally aligned along the first row of struts of the frame body, the first row of struts of the supplemental frame having a shape which generally matches the shape of the first row of struts of the frame body;

a proximal anchoring feature, the proximal anchoring feature sized to be positioned on a first side of an annulus of the native heart valve; and

a distal anchoring feature, the distal anchoring feature sized to be positioned on a second side of an annulus of the native heart valve; and

a valve body positioned within an interior of the expandable frame, the valve body comprising a plurality of leaflets configured to allow flow in a first direction and prevent flow in a second opposite direction;

wherein the prosthesis comprises an annular skirt extending around the exterior of the expandable frame; and

at least one of the valve body and the annular skirt comprises one or more openings configured to allow at least one of;

fluid ingress into a space between the valve leaflets and the annular skirt; and

fluid egress out of the space between the valve leaflets and the annular skirt.

24. The prosthesis of claim 23, wherein:

the annular skirt comprises a supplemental rib extending from a portion of the annular skirt; and

the annular skirt extends to different radial dimensions with a first peripheral region extending to a first radial dimension and a second peripheral region extending to a second radial dimension greater than the first radial dimension.

25. A replacement heart valve prosthesis for deployment at a native heart valve, the prosthesis comprising:

an expandable frame configured to radially expand and contract for deployment within a native heart valve, the expandable frame comprising;

a frame body comprising a proximal region, a distal region, and an intermediate region extending between the proximal and distal regions, the frame body comprising a first row of struts and a second row of struts;

a supplemental frame comprising a first row of struts configured to be generally aligned along the first row of struts of the frame body, the first row of struts of the supplemental frame having a shape which generally matches the shape of the first row of struts of the frame body;

a proximal anchoring feature, the proximal anchoring feature sized to be positioned on a first side of an annulus of the native heart valve; and

a distal anchoring feature, the distal anchoring feature sized to be positioned on a second side of an annulus of the native heart valve; and

a valve body positioned within an interior of the expandable frame, the valve body comprising a plurality of leaflets configured to allow flow in a first direction and prevent flow in a second opposite direction;

wherein the supplemental frame is formed separately from the frame body and the first row of struts of the supplemental frame is configured to be attached to at least a portion of the first row of struts of the frame body; and

wherein the first row of struts of the supplemental frame is attached to the first row of struts of the frame body via sutures.