Prosthetic heart valve having multi-level sealing member

• US 10,179,043 B2
• Filed: 02/06/2017
• Issued: 01/15/2019
• 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 JAIME J
• Application Number:
  US15/425,029
• Publication Number:
  US 20170231761A1
• Time in Patent Office: 708 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

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

wherein one or more of the outer skirts comprise 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 inflow edge of at least one of the two or more outer skirts is secured to the frame with sutures including radiopaque material.

3. The valve of claim 1, wherein at least one of the two or more outer skirts comprises markings formed from radiopaque dye.

4. The valve of claim 1, wherein the outflow edges of at least two of the two or more outer skirts are secured at intervals to the frame and include openings between the intervals that are unsecured to the frame.

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

6. The valve of claim 1, wherein outflow edge of at least one of the two or more outer skirts is unsecured to the frame.

7. The valve of claim 1, wherein the axial spacing between the two or more outer skirts is less than the axial height of a least one of the two or more outer skirts.

8. The valve of claim 1, wherein the two or more outer skirts are positioned in series along the length of the frame between an inflow edge of the frame and an outflow edge of the frame.

9. The valve of claim 1, wherein the inflow edge of at least one of the two or more outer skirt contacts the outflow edge of another one of the two or more outer skirts without any axial spacing between.

18. The valve of claim 1, wherein the fringes are formed along the outflow edges of the one or more outer skirts.

10. An implantable prosthetic valve that is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration, the prosthetic valve comprising:

an annular frame;

a leaflet structure positioned within the frame;

a plurality of outer skirts positioned around an outer surface of the frame, each outer skirt extending continuously around the entire extent of a circumference of the frame, each outer skirt comprising an inflow edge secured to the frame and an outflow edge; and

wherein the outflow edge of each outer skirt 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.

11. The valve of claim 10, wherein the first outer skirt comprises markings formed from radiopaque dye.

12. The valve of claim 10, wherein the plurality of outer skirts further includes a third outer skirt, wherein in the expanded configuration the third outer skirt includes notches unsecured to the frame between the projections.

13. The valve of claim 10, wherein the openings of the first outer skirt and the second outer skirt are circumferentially aligned.

14. The valve of claim 10, wherein the openings do not lie flat against the outer surface of the frame in the expanded configuration.

15. The valve of claim 10, wherein the inflow edge of the second outer skirt contacts the outflow edge of the first outer skirt without any axial spacing between.

16. The valve of claim 10, wherein the plurality of outer skirts are positioned in series along the length of the frame between an inflow edge of the frame and an outflow edge of the frame.

17. The valve of claim 10, wherein the axial height of a least two of the plurality of skirts is the same.

19. The valve of claim 10, wherein the plurality of skirts includes a first outer skirt and a second outer skirt, and wherein the notches of the first outer skirt are circumferentially offset from the notches of the second outer skirt.