Prosthetic heart valve having leaflet inflow below frame

• US 10,463,484 B2
• Filed: 11/09/2017
• Issued: 11/05/2019
• Est. Priority Date: 11/17/2016
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Levi, Tamir S.
• Primary Examiner(s): Sharma, Yashita
• Assistant Examiner(s): Preston, Rebecca S
• Application Number:
  US15/808,599
• Publication Number:
  US 20180133003A1
• Time in Patent Office: 726 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 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2/2454 Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
• CPC Class Codes: A61F 2/2463 Implants forming part of the valve leaflets
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/91575 connected peak to trough
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• 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 2230/0006 circular
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility

Abstract

Embodiments of a prosthetic heart valve are disclosed. An implantable prosthetic valve can include an annular frame having an inflow end, an outflow end and a central longitudinal axis extending from the inflow end to the outflow end. The valve can include a valvular structure including two or more leaflets, each of the two or more leaflets having a leaflet inflow edge positioned at least partially outside of the frame and a leaflet outflow edge positioned within the frame, wherein at least a portion of each of the leaflet inflow edges is unsupported by the frame.

Claims

1. An implantable prosthetic valve comprising:

an annular frame having an inflow end, an outflow end and a central longitudinal axis extending from the inflow end to the outflow end;

a valvular structure including two or more leaflets, each of the two or more leaflets having a leaflet inflow edge positioned at least partially outside of the frame and a leaflet outflow edge positioned within the frame, wherein at least a portion of each of the leaflet inflow edges is unsupported by the frame;

an inner skirt having a first portion that extends circumferentially around the central longitudinal axis along an inner surface of the frame and is supported by the frame and a second portion that extends circumferentially around the central longitudinal axis outside of the frame and is not supported by the frame; and

an outer sealing member secured on both an outer surface of the frame and an outer surface of the second portion of inner skirt

wherein the portion of the leaflet inflow edges unsupported by the frame is connected to the second portion of the inner skirt.

2. The valve of claim 1, wherein the inner skirt includes a first set of fibers that are sufficiently stiff to impede inward bending of the second portion due to systolic pressure gradient and blood flowing from the left ventricle to the aorta.

3. The valve of claim 2, wherein the first set of fibers include monofilaments.

4. The valve of claim 1, wherein the portions of the leaflet inflow edges unsupported by the frame each include an apex portion of each leaflet.

5. The valve of claim 1, wherein the frame includes at least two rows of cells extending circumferentially around the central longitudinal axis and the at least two rows of cells define openings;

the openings having a length in an axial direction and wherein a length of the portion of the inflow edges unsupported by the frame is equal to or greater than the length of the openings.

6. The valve of claim 1, wherein the outer sealing member has an inflow edge portion that is axially spaced from the frame and is sutured to the second portion of the inner skirt.

7. The valve of claim 6, wherein the inflow end portion of the outer sealing member is unsupported by any struts of the frame.

8. The valve of claim 7, wherein the outer sealing member has an outflow edge portion sutured to struts of the frame.

9. The valve of claim 1, wherein the portions of the leaflet inflow edges unsupported by the frame are unsupported by any metal struts.

10. The valve of claim 1, wherein the frame comprises a circumferentially extending row of struts defining the inflow end of the frame and the portions of the leaflet inflow edges unsupported by the frame extend away from the inflow end of the frame and are outside of the frame.

11. An implantable prosthetic valve comprising:

an annular frame having an inflow end, an outflow end and a central longitudinal axis extending from the inflow end to the outflow end;

a valvular structure including two or more leaflets, each of the two or more leaflets having a leaflet inflow edge positioned at least partially outside of the frame and a leaflet outflow edge positioned within the frame, wherein at least a portion of each of the leaflet inflow edges is unsupported by the frame; and

an inner skirt, wherein a first portion of the inner skirt extends circumferentially around the central longitudinal axis along an inner surface of the frame and a second portion of the inner skirt extends circumferentially around the central longitudinal axis outside of the frame;

wherein the inner skirt includes a first set of fibers that are sufficiently stiff to impeded inward bending of the second portion due to systolic pressure gradient and blood flowing from the left ventricle to the aorta; and

wherein the first set of fibers run parallel to the central longitudinal axis.

12. An implantable prosthetic valve comprising:

an annular frame having an inflow end, an outflow end and a central longitudinal axis extending from the inflow end to the outflow end;

a valvular structure including two or more leaflets, each of the two or more leaflets having a leaflet inflow edge positioned at least partially outside of the frame and a leaflet outflow edge positioned within the frame, wherein at least a portion of each of the leaflet inflow edges is unsupported by the frame; and

an inner skirt, wherein a first portion of the inner skirt extends circumferentially around the central longitudinal axis along an inner surface of the frame and a second portion of the inner skirt extends circumferentially around the central longitudinal axis outside of the frame;

wherein the inner skirt includes a first set of fibers that are sufficiently stiff to impeded inward bending of the second portion due to systolic pressure gradient and blood flowing from the left ventricle to the aorta; and

wherein the inner skirt includes a second set of fibers that run perpendicular to the first set of fibers, wherein the first set of fibers are stiffer than the second set of fibers.

13. An implantable prosthetic valve, the prosthetic valve comprising:

an annular frame having an inflow end, an outflow end and a central longitudinal axis extending from the inflow end to the outflow end;

an inner skirt, wherein a first portion of the inner skirt extends circumferentially around the central longitudinal axis along an inner surface of the frame and a second portion of the inner skirt extends circumferentially around the central longitudinal axis outside of the frame; and

a valvular structure including two or more leaflets, each of the two or more leaflets having a leaflet inflow edge positioned at least partially outside of the frame and a leaflet outflow edge positioned within the frame, wherein at least a portion of each of the leaflet inflow edges is connected to the second portion of the inner skirt;

wherein the inner skirt includes a first set of fibers and a second set of fibers that runs perpendicular to the first set of fibers, wherein the first set of fibers is stiffer than the second set of fibers.

14. The valve of claim 13, wherein the frame includes a row of cells defining openings;

the openings having a length in an axial direction and further wherein a length of the second portion is equal to or greater than the length of the openings.

15. The valve of claim 13, further comprising an outer sealing member connected to the second portion of the inner skirt.

16. The valve of claim 13, wherein the portions of the leaflet inflow edges connected to the second portion of the inner skirt include an apex portion of each leaflet.

17. An implantable prosthetic valve comprising:

an annular frame having an inflow end, an outflow end and a central longitudinal axis extending from the inflow end to the outflow end;

a valvular structure including two or more leaflets, each of the two or more leaflets having a leaflet inflow edge positioned at least partially outside of the frame and a leaflet outflow edge positioned within the frame, wherein at least a portion of each of the leaflet inflow edges is unsupported by the frame;

an inner skirt, having a first portion that extends circumferentially around the central longitudinal axis along an inner surface of the frame and is supported by the frame and a second portion that extends circumferentially around the central longitudinal axis outside of the frame and is not supported by the frame;

an outer sealing member mounted on the outside of the frame;

a support layer, wherein a first portion of the support layer extends circumferentially around the central longitudinal axis along an outer surface of the frame and a second portion of the support layer extends circumferentially around the central longitudinal axis axially beyond the inflow end of the frame;

wherein the portions of the leaflet inflow edges unsupported by the frame are connected to both the second portion of the inner skirt and the second portion of the support layer.

18. The valve of claim 17, wherein the outer sealing member is positioned radially outside of the support layer and is connected to the second portion of the support layer at an inflow end of the outer skirt.

19. The valve claim 17, wherein the support layer includes a first set of fibers and a second set of fibers that runs perpendicular to the first set of fibers, wherein the first set of fibers is stiffer than the second set of fibers.

20. The valve of claim 19, wherein the first set of fibers includes monofilaments.

21. The valve of claim 17, wherein portion of each leaflet inflow edge unsupported by the frame includes an apex portion of each leaflet.