Prosthetic heart valve

• US 9,393,110 B2
• Filed: 10/05/2011
• Issued: 07/19/2016
• Est. Priority Date: 10/05/2010
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Levi, Tamir S., Nguyen, Son V., Benichou, Netanel, Maimon, David, Yohanan, Ziv, Gurovich, Nikolay, Felsen, Bella, Dadonkina, Larisa, Sharoni, Ron, Sherman, Elena
• Primary Examiner(s): Scherbel, Todd J
• Application Number:
  US13/253,689
• Publication Number:
  US 20120123529A1
• Time in Patent Office: 1,749 Days
• Field of Search: 623/2.11, 623/2.12, 623/2.17, 623/2.19, 623/1.11, 623/1.12, 623/1.24, 623/1.26
• US Class Current: 1/1
• 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 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0036 differing in thickness
• CPC Class Codes: A61F 2250/0069 Sealing means
• CPC Class Codes: A61F 2250/0097 Visible markings, e.g. indicia

Abstract

Embodiments of a radially collapsible and expandable prosthetic heart valve are disclosed. A valve frame can have a tapered profile when mounted on a delivery shaft, with an inflow end portion having a smaller diameter than an outflow end portion. The valve can comprise generally V-shaped leaflets, reducing material within the inflow end of the frame. An outer skirt can be secured to the outside of the inflow end portion of the frame, the outer skirt having longitudinal slack when the valve is expanded and lying flat against the frame when the valve is collapsed. A diagonally woven inner skirt can elongate axially with the frame. Side tabs of adjacent leaflets can extend through and be secured to window frame portions of the frame to form commissures. The window frame portions can be depressed radially inward relative to surrounding frame portions when the valve is crimped onto a delivery shaft.

Claims

1. An assembly for implanting a prosthetic heart valve in a patient'"'"'s body comprising:

a delivery apparatus comprising an elongated shaft; and

a radially expandable prosthetic heart valve adapted to be mounted on the shaft in a radially collapsed configuration for delivery into the body, the prosthetic heart valve comprising an annular frame having an inflow end portion defining an inflow end of the frame that is configured to receive antegrade blood flow into the prosthetic heart valve when implanted, and the annular frame also having an outflow end portion defining an outflow end of the frame opposite the inflow end of the frame, the prosthetic heart valve also comprising a leaflet structure positioned within the frame, an inner fabric skirt positioned along an inner surface of the frame, and an outer fabric skirt extending from the inflow end of the frame along an outer surface of the frame to a frame attachment location;

wherein the frame is adapted to shorten axially during radial expansion of the prosthetic valve, thereby increasing axial slack in the outer fabric skirt; and

wherein the outer fabric skirt comprises an edge defining a plurality of alternating projections and notches that is attached to the frame at the frame attachment location.

2. The assembly of claim 1, wherein an outer diameter of the inflow end portion of the frame is smaller than an outer diameter of the outflow end portion of the frame.

3. The assembly of claim 1, wherein the leaflet structure comprises a plurality of leaflets, wherein each of the leaflets comprises:

opposing side tabs on opposite sides of the leaflet, the side tabs being secured to the outflow end portion of the frame;

a free outflow edge portion extending between the side tabs adjacent to the outflow end of the frame; and

an inflow edge portion extending between the side tabs adjacent to the inflow end of the frame, the inflow edge portion comprising opposing axial edge portions that extend from the side tabs toward the inflow end of the frame in a generally axial direction and an intermediate edge portion that extends between the axial edge portions, the intermediate edge portion comprising a curved apex portion adjacent to the inflow end of the frame and a pair of oblique portions that extend between the axial edge portions and the apex portion, the oblique portions having a greater radius of curvature than the apex portion.

4. The assembly of claim 1, wherein the frame comprises three angularly spaced commissure windows each comprising an enclosed opening between first and second axially oriented side struts;

and

the leaflet structure comprises a plurality of leaflets each comprising two opposing side tabs, each side tab being paired with an adjacent side tab of an adjacent leaflet to form commissures of the leaflet structure, and wherein each commissure extends radially outwardly through a corresponding commissure window of the frame to a location outside of the frame and is sutured to the side struts of the commissure window.

5. The assembly of claim 4, wherein the commissure windows of the frame are depressed radially inwardly relative to the portions of the frame extending between adjacent commissure windows when the prosthetic valve is in the radially collapsed configuration on the shaft.

6. The assembly of claim 1, wherein the frame comprises an inflow row of openings at the inflow end portion of the frame, an outflow row of openings at the outflow end portion of the frame, and at least one intermediate row of openings between the inflow row of openings and the outflow row of openings;

wherein the openings of the inflow row of openings are larger than the openings of the at least one intermediate row of openings.

7. The assembly of claim 1, wherein the frame has a plurality of openings and portions of the leaflet structure protrude through the openings while the prosthetic valve is in the radially collapsed configuration.

8. The assembly of claim 1, wherein the inflow end portion of the frame comprises a frame thickness that is less than a frame thickness of an intermediate portion of the frame between the inflow end portion and the outflow end portion.

9. The valve of claim 1, wherein the outer fabric skirt extends from the inflow end of the frame along the outer surface of the frame to a plurality of outer skirt attachment locations on the outer surface of frame, and wherein distances from the inflow end of the frame to the plurality of outer skirt attachment locations become smaller when the prosthetic heart valve is radially expanded.

10. The valve of claim 9, wherein when the prosthetic heart valve is radially expanded, the plurality of outer skirt attachment locations and the inflow end of the frame are at substantially the same radial distance from a longitudinal center axis of the prosthetic heart valve.

11. The valve of claim 1, wherein the projections at the edge of the outer skirt are attached to the frame and the notches in the edge of the outer skirt are not attached to the frame.

12. An assembly for implanting a prosthetic heart valve in a patient'"'"'s body comprising:

a delivery apparatus comprising an elongated shaft;

a radially expandable and collapsible prosthetic heart valve mounted on the shaft in a radially collapsed configuration for delivery into the body, the prosthetic heart valve comprising an annular frame and a leaflet structure within the frame;

wherein the frame comprises a plurality of angularly spaced commissure windows each comprising an enclosed opening between first and second axially oriented side struts, and the frame further comprises intermediate side struts that are axially oriented and positioned angularly between the commissure windows, and the leaflet structure comprises a plurality of commissure portions that extend outwardly through respective commissure windows to locations outside of the frame; and

wherein the commissure windows are depressed radially inwardly relative to the intermediate side struts when the prosthetic heart valve is radially collapsed on the shaft, such that an outermost surface of each commissure portion of the leaflet structure outside of the frame is at substantially the same radial distance from a longitudinal center axis of the prosthetic heart valve as outer surfaces of the intermediate side struts.

13. The valve of claim 12, wherein the commissure windows of the frame are depressed inwardly a radial distance of between 0.2 mm and 1.0 mm relative to the intermediate side struts when the valve is radially collapsed.

14. The valve of claim 12, wherein an outer diameter of an inflow end portion of the frame is smaller than an outer diameter of an outflow end portion of the frame when the valve is radially collapsed on the shaft.

15. The assembly of claim 12, wherein an outer surface of the frame defines radial depressions in regions proximate the commissure windows, and outer portions of the commissure portions of the leaflet structure are located in the radial depressions along the outside of the frame.

16. The assembly of claim 12, wherein the commissure portions of the leaflet structure are sutured to the axially oriented side struts of the commissure windows.

17. 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 having a longitudinal axis extending between an inflow end of the frame and an outflow end of the frame and defining an axial direction, the inflow end of the frame being configured to receive antegrade blood flow into the prosthetic valve when implanted;

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 positioned at a first location at the inflow end of the frame, an outflow edge defining a plurality of spaced apart axial projections that are secured to the frame at a second location axially spaced from the inflow edge, and an intermediate portion extending between the inflow edge and the outflow edge and positioned outside of the frame;

wherein when the valve is in the expanded configuration, the intermediate portion of the outer skirt comprises slack in the axial direction between the inflow edge of the outer skirt and the outflow edge of the outer skirt, and when the valve is collapsed to the collapsed configuration, the distance between the inflow edge of the outer skirt and the outflow edge of the outer skirt increases, reducing the slack in the outer skirt in the axial direction.

18. The valve of claim 17, wherein the outflow edge of the outer skirt comprises a plurality of alternating projections and notches, the projections being secured to the frame at the second location, the outer skirt being unsecured to the frame at the notches.

19. The valve of claim 17, wherein the outer skirt is not stretched in the axial direction when the valve is radially collapsed to the collapsed configuration and slack is removed from the intermediate portion of the outer skirt.

20. An implantable prosthetic valve comprising:

an annular frame comprising a plurality of leaflet attachment portions; and

a leaflet structure positioned within the frame and secured to the leaflet attachment portions of the frame, the leaflet structure comprising a plurality of leaflets, each leaflet comprising a body portion having a free outflow edge, two opposing primary side tabs extending from opposite sides of the body portion, and two opposing secondary tabs, each secondary tab extending from the body portion adjacent to a respective primary side tab, the secondary tabs extending from the body portion at opposite ends of the free outflow edge;

wherein the secondary tabs are folded about radially extending creases that extend radially from the opposite ends of the free outflow edge, such that a first portion of the secondary tabs lies flat against the body portion of the respective leaflet, and the secondary tabs are folded about axially extending creases such that a second portion of the secondary tabs extends in a different plane than the first portion, wherein the radially extending creases and the axially extending creases are non-parallel.

21. The valve of claim 20, wherein the second portion of each secondary tab is sutured to a respective primary tab.

22. The valve of claim 20, wherein the secondary tabs are positioned inside of the frame.

23. The valve of claim 20, wherein the first portion of each the secondary tab pivots about the axially extending crease and lays flat against the second portion of the secondary tab when the valve is collapsed to a radially collapsed configuration.

24. The valve of claim 20, wherein the first portion of each secondary tab extends radially inwardly from the frame and comprises an inner edge spaced radially from an inner surface of the frame, and the body portion of the leaflet articulates about the inner edges of the two secondary tabs of the leaflet in response to blood flowing through the valve when the valve is in operation within a patient'"'"'s body.

25. The valve of claim 20, wherein the plurality of leaflet attachment portions comprises window frame portions each comprising an enclosed opening between first and second axially oriented side struts, and wherein the primary side tabs extend radially outwardly through respective window frame portions to a location outside of the frame and are sutured to the secondary tabs to secure the leaflets around the side struts.