Prosthetic heart valve

• US 9,974,650 B2
• Filed: 07/13/2016
• Issued: 05/22/2018
• Est. Priority Date: 07/14/2015
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Nguyen-Thien-Nhon, Diana, Geiser, Timothy A., Wood, Larry L., Sirimanne, Dinesh L., Nguyen, Son, Levi, Tamir S., Gurovich, Nikolay, Bukin, Michael
• Primary Examiner(s): SWEET, THOMAS
• Assistant Examiner(s): Mathew, Seema
• Application Number:
  US15/209,642
• Publication Number:
  US 20170014229A1
• Time in Patent Office: 678 Days
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• 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 2230/0026 trapezoidal
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0093 Umbrella-shaped, e.g. mushroom-shaped
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

An implantable prosthetic valve can comprise an annular frame comprising an inflow end and an outflow end and being radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration, the frame defining an axial direction extending from the inflow end to the outflow end, a leaflet structure positioned within the frame and secured thereto, and an annular outer skirt positioned around an outer surface of the frame, wherein the outer skirt comprises an inflow edge secured to the frame at a first location, an outflow edge comprising a plurality of alternating projections and notches, wherein the projections are secured to the frame at a second location, and the notches are not directly secured to the frame, an intermediate portion between the inflow edge and the outflow edge that comprises a plurality of openings.

Claims

1. An implantable prosthetic valve comprising:

an annular frame comprising an inflow end and an outflow end and being radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration, the frame defining an axial direction extending from the inflow end to the outflow end;

a leaflet structure positioned within the frame and secured thereto; and

an annular outer skirt positioned around an outer surface of the frame, wherein the outer skirt comprises;

an inflow edge secured to the frame at a first location;

an outflow edge comprising a plurality of alternating projections and notches, wherein the projections are secured to the frame at a second location, and the notches are not directly secured to the frame;

an intermediate portion between the inflow edge and the outflow edge that comprises a plurality of openings; and

a plurality of axially extending creases, wherein each of the openings of the outer skirt is circumferentially aligned with a respective crease of the outer skirt.

2. The prosthetic valve of claim 1, wherein when the frame is in the collapsed configuration, the axial distance between the inflow edge of the outer skirt and the outflow edge of the outer skirt is greater than when the valve is in the expanded configuration, increasing tension of the intermediate portion of the outer skirt.

3. The prosthetic valve of claim 1, wherein the outer skirt comprises a first height, and the frame in the radially expanded configuration comprises a second height, and wherein a ratio of the first height to the second height about 0.75 to about 0.95.

4. The prosthetic valve of claim 3, wherein the ratio of the first height to the second height is 0.86.

5. The prosthetic valve of claim 1, wherein the creases are formed by suturing portions of the outer skirt to each other.

6. The prosthetic valve of claim 1, wherein the creases are formed by ultrasonic welding portions of the outer skirt to each other.

7. The prosthetic valve of claim 1, wherein each of the creases of the outer skirt is circumferentially aligned with a respective projection of the outer skirt.

8. The prosthetic valve of claim 1, wherein the outer skirt is positioned relative to the frame such that each of the creases of the outer skirt is circumferentially positioned between a respective pair of apices formed by struts at the inflow end of the frame.

9. The prosthetic valve of claim 8, wherein each of the creases is positioned equidistantly between a respective pair of apices.

10. The prosthetic valve of claim 1, further comprising an annular inner skirt positioned around an inner surface of the frame, wherein the inner skirt comprises an inflow edge secured to the frame at a third location, an outflow edge secured to the frame at a fourth location.

11. The prosthetic valve claim 10, wherein the inflow edge of the outer skirt is attached to the inflow edge of the inner skirt.

12. The prosthetic valve of claim 11, wherein the inflow edge of the outer skirt is attached to the inflow edge of the inner skirt with sutures.

13. The prosthetic valve of claim 11, wherein the inflow edge of the outer skirt is attached to the inflow edge of the inner skirt by ultrasonic welding.

14. The prosthetic valve of claim 1, wherein at least a portion of the outer skirt is configured to retract radially within the frame when the frame is the radially collapsed configuration.

15. The prosthetic valve of claim 1, wherein the outer skirt is configured such that blood can flow through the openings and the notches of the outer skirt and blood can flow through a space between the outer skirt and the frame.

16. The prosthetic valve of claim 1, wherein the outer skirt is attached to the frame such that each of the projections of the outer skirt is circumferentially positioned between a respective pair of apices formed by struts at the inflow end of the frame.

17. An implantable prosthetic valve comprising:

an annular frame comprising an inflow end and an outflow end and being radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration, the frame defining an axial direction extending from the inflow end to the outflow end;

a leaflet structure positioned within the frame and secured thereto; and

an annular outer skirt positioned around an outer surface of the frame, wherein the outer skirt comprises;

an inflow edge secured to the frame at a first location;

an outflow edge comprising a plurality of alternating projections and notches, wherein the projections are secured to the frame at a second location, and the notches are not directly secured to the frame;

an intermediate portion between the inflow edge and the outflow edge that comprises a plurality of openings; and

a plurality of axially extending creases, wherein each of the creases of the outer skirt is circumferentially aligned with a respective projection of the outer skirt.

18. An implantable prosthetic valve comprising:

an annular frame comprising an inflow end and an outflow end and being radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration, the frame defining an axial direction extending from the inflow end to the outflow end;

a leaflet structure positioned within the frame and secured thereto; and

an annular outer skirt positioned around an outer surface of the frame, wherein the outer skirt comprises;

an inflow edge secured to the frame at a first location;

an outflow edge comprising a plurality of alternating projections and notches, wherein the projections are secured to the frame at a second location, and the notches are not directly secured to the frame;

an intermediate portion between the inflow edge and the outflow edge that comprises a plurality of openings; and

a plurality of axially extending creases, wherein the outer skirt is positioned relative to the frame such that each of the creases of the outer skirt is circumferentially positioned between a respective pair of apices formed by struts at the inflow end of the frame;

wherein each of the creases of the outer skirt is circumferentially aligned with a respective projection of the outer skirt.

19. The prosthetic valve of claim 18, wherein each of the creases is positioned equidistantly between a respective pair of apices.

20. An implantable prosthetic valve comprising:

an annular frame comprising an inflow end and an outflow end and being radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration, the frame defining an axial direction extending from the inflow end to the outflow end;

a leaflet structure positioned within the frame and secured thereto; and

an annular outer skirt positioned around an outer surface of the frame, wherein the outer skirt comprises;

an inflow edge secured to the frame at a first location;

an outflow edge comprising a plurality of alternating projections and notches, wherein the projections are secured to the frame at a second location, and the notches are not directly secured to the frame; and

an intermediate portion between the inflow edge and the outflow edge that comprises a plurality of openings,

wherein the outer skirt comprises a first height, and the frame in the radially expanded configuration comprises a second height, and wherein a ratio of the first height to the second height is 0.75 to 0.95 wherein the outer skirt comprises a plurality of axially extending creases, wherein each of the creases of the outer skirt is circumferentially aligned with a respective projection of the outer skirt.

21. The prosthetic valve of claim 20, wherein the ratio of the first height to the second height is 0.86.

22. The prosthetic valve of claim 20, wherein the outer skirt is positioned relative to the frame such that each of the creases of the outer skirt is circumferentially positioned between a respective pair of apices formed by struts at the inflow end of the frame.

23. The prosthetic valve of claim 22, wherein each of the openings of the outer skirt is circumferentially aligned with a respective crease of the outer skirt, and wherein each of the creases of the outer skirt is circumferentially aligned with a respective projection of the outer skirt.