Prosthetic heart valve having multi-level sealing member

• US 10,722,354 B2
• Filed: 12/10/2018
• Issued: 07/28/2020
• Est. Priority Date: 02/12/2016
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Cohen-Tzemach, Hanoch, Levi, Tamir S., Nir, Noam, Felsen, Bella
• Primary Examiner(s): Gherbi, Suzette J
• Application Number:
  US16/214,561
• Publication Number:
  US 20190105154A1
• Time in Patent Office: 596 Days
• Field of Search: 623 21- 219
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• 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 2230/0017 Angular shapes
• CPC Class Codes: A61F 2230/0026 trapezoidal
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2250/0069 Sealing means
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

Embodiments of a prosthetic heart valve are disclosed. An implantable prosthetic valve may be radially collapsible to a collapsed configuration and radially expandable to an expanded configuration. The prosthetic valve may comprise an annular frame, a leaflet structure positioned within the frame and a plurality of outer skirts positioned around an outer surface of the frame, each outer skirt comprising an inflow edge secured to the frame and an outflow edge secured at intervals to the frame. The plurality of outer skirts may include a first outer skirt and a second outer skirt, wherein in the expanded configuration the first and second outer skirts include openings unsecured to the frame between the intervals. The inflow edge of the first annular outer skirt may be secured to the frame with sutures including radiopaque material. The first annular outer skirt may include radiopaque dye.

Claims

1. An implantable prosthetic valve comprising:

an annular frame;

a leaflet structure positioned within the frame; and

an annular outer skirt positioned around an outer surface of the frame, the outer skirt comprising an inflow edge secured to the frame and an outflow edge, wherein the outflow edge defines one or more upper openings allowing retrograde blood to flow between the outer surface of the frame and the outer skirt to create a plurality of regions of turbulent blood flow along the outside of the prosthetic valve; and

wherein the outer skirt comprises a fabric formed with fringes that perturb the flow of blood along the outside of the prosthetic valve.

2. The valve of claim 1, wherein the fringes are formed along the outflow edge of the outer skirt.

3. The valve of claim 1, wherein the inflow edge of the outer skirt is secured to the frame with sutures including radiopaque material.

4. The valve of claim 1, wherein the outer skirt comprises markings formed from radiopaque dye.

5. The valve of claim 1, wherein the outflow edge of the outer skirt is secured at intervals to the frame and includes openings between the intervals that are unsecured to the frame.

6. The valve of claim 1, wherein the one or openings do not lie flat against the outer surface of the frame in an expanded configuration.

7. The valve of claim 1, wherein the outflow edge of the outer skirt is unsecured to the frame.

8. The valve of claim 1, wherein the fabric of the outer skirt comprises filaments configured to bias the outer skirt to a deployed configuration.

9. The valve of claim 8, wherein the filaments are Nitinol wires.

10. The valve of claim 1, wherein the outer skirt is formed from a shape-set material configured to bias the outflow edge of the outer skirt radially away from the frame.

11. The valve of claim 10, wherein the shape-set material is polyethylene terephthalate (PET).

12. An implantable prosthetic valve, comprising:

an annular frame;

a leaflet structure positioned within the frame;

a sealing member positioned around an outer surface of the frame, the sealing member extending continuously around an entire circumference of the frame, the sealing member comprising an inflow edge secured to the frame and an outflow edge; and

wherein the sealing member comprises a fabric formed with fringes that perturb the flow of blood along the outside of the prosthetic valve.

13. The valve of claim 12, wherein the fringes are formed along the outflow edge of the sealing member.

14. The valve of claim 12, wherein the sealing member comprises markings formed from radiopaque dye.

15. The valve of claim 12, wherein the outflow edge of the sealing member comprises alternating projections and notches, the projections being secured to the frame and the notches being unsecured to the frame such that each notch defines an opening.

16. The valve of claim 15, wherein the openings do not lie flat against the outer surface of the frame when the valve is in the expanded configuration.

17. The valve of claim 12, wherein the outflow edge of the sealing member is unsecured to the frame.

18. The valve of claim 12, wherein the inflow edge of the sealing member is attached to the frame with sutures that comprise radiopaque material.

19. The valve of claim 12, wherein the sealing member is formed from a shape-set material configured to bias the outflow edge of the sealing member radially away from the frame.

20. The valve of claim 19, wherein the shape-set material is polyethylene terephthalate (PET).