Low profile transcatheter heart valve

Patent metadata

Field	Value
Publication number	US-11648111-B2
Application number	US-202117558322-A
Country	US
Kind code	B2
Filing date	Dec 21, 2021
Priority date	Jun 6, 2008
Publication date	May 16, 2023
Grant date	May 16, 2023

Abstract

An implantable prosthetic valve includes a radially collapsible and expandable annular frame having three commissure attachment posts and four rows of circumferential struts. The rows include a first row, a second row downstream of the first row, a third row downstream of the second row, and a fourth row downstream of the third row and defining an outflow end of the frame. Each row of circumferential struts includes angled struts arranged in a zig-zag pattern. A leaflet structure includes three leaflets forming three commissures, each commissure being connected to one of the commissure attachment posts only at locations along the commissure attachment posts between a first plane that is perpendicular to a longitudinal axis of the frame and intersects crowns of the third row of struts and a second plane that is perpendicular to the longitudinal axis and intersects crowns of the fourth row of struts.

First claim

We claim:

1. An assembly comprising:
a delivery catheter comprising a balloon; and
an implantable prosthetic heart valve that is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration, the prosthetic heart valve comprising:
a radially collapsible and expandable annular frame, the frame having three commissure attachment posts and at least three rows of circumferential struts including a first row of circumferential struts defining an inflow end of the frame and second and third rows of circumferential struts spaced apart from the first row adjacent an outflow end of the frame, each row of circumferential struts comprising angled struts arranged in a zig-zag pattern defining a plurality of crowns;
a leaflet structure comprising three leaflets formed of pericardial tissue, each leaflet having an upper edge, a curved lower edge and two side flaps, wherein each side flap is secured to an adjacent side flap of another leaflet to form commissures of the leaflet structure, each commissure being sutured to one of the commissure attachment posts via sutures extending through apertures in the commissure attachment posts, wherein all of the apertures are located along the length of the frame between a first plane that is perpendicular to the length and defined by the crowns of the second row of circumferential struts and a second plane that is perpendicular to the length and defined by the crowns of the third row of circumferential struts; and
an annular skirt secured to the inside of the annular frame and to the leaflet structure, the curved lower edge of each leaflet sutured to an inner surface of the skirt;
wherein the collapsed prosthetic heart valve can be mounted around the balloon and radially expanded to the expanded configuration with the balloon inside a patient's body.

2. The assembly of claim 1 , wherein the prosthetic heart valve further comprises a reinforcing strip, separate from the annular skirt member, secured to an inner surface of the leaflet structure adjacent its curved lower edge such that the leaflets are sandwiched between the annular skirt member and the reinforcing strip.

3. The assembly of claim 1 , wherein the crowns comprise U-shaped crown structures that interconnect adjacent ends of two angled struts, wherein the U-shaped crown structure comprises a first portion connected to and extending at a non-zero angle from the end of one of the struts, a second portion connected to and extending at a non-zero angle from the adjacent end of the other strut, and a third, intermediate portion extending between and connecting the first and second portions such that a gap is defined between the first and second portions and the adjacent ends of the struts.

4. The assembly of claim 1 , wherein the skirt member has an upper edge and a lower edge, the upper edge being sutured to each strut of the second row of struts, and the lower edge being sutured to each strut of the first row of struts.

5. The assembly of claim 4 , wherein the upper edge of the skirt is shaped to correspond to the zig-zag pattern of the second row of struts.

6. The assembly of claim 4 , wherein each strut of the second row of struts is sutured to the upper edge of the skirt with a suture comprising a plurality of suture loops extending around the strut and through the upper edge of the skirt.

7. The assembly of claim 1 , wherein the second and third row of struts define a row of cells defining openings in the frame along an outflow portion of the frame and wherein the skirt member covers an entire extent of an inner surface of the frame except for the openings in the row of cells.

8. The assembly of claim 1 , wherein the frame is made of a plastically-expandable material.

9. The assembly of claim 8 , wherein the plastically-expandable material comprises a nickel cobalt chromium alloy.

10. The assembly of claim 1 , wherein each commissure attachment post is connected to adjacent ends of two struts of the second row of struts at a junction and extends from the junction toward the outflow end of the frame.

11. The assembly of claim 10 , wherein each commis sure attachment post includes apertures located downstream of the junction.

12. The assembly of claim 11 , wherein each commissure attachment post includes an aperture located upstream of the junction.

13. An assembly comprising:
a delivery catheter comprising a balloon; and
an implantable prosthetic heart valve that is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration, the prosthetic heart valve comprising:
a radially collapsible and expandable annular frame, the frame having three commissure attachment posts and at least three rows of circumferential struts including a first row of circumferential struts defining an inflow end of the frame, a second row of circumferential struts downstream of the first row, and a third row of circumferential struts spaced downstream of the second row and defining an outflow end of the frame, each row of circumferential struts comprising angled struts arranged in a zig-zag pattern, wherein the second and third row of struts define a row of cells defining openings in the frame along an outflow portion of the frame;
a leaflet structure comprising three leaflets forming three commissures of the leaflet structure, each commis sure being connected to one of the commis sure attachment posts only at locations along the commis sure attachment posts between the outflow end of the frame and an upstream end of the row of cells; and
an annular outer skirt extending around an outer surface of the frame;
wherein the collapsed prosthetic heart valve can be mounted around the balloon and radially expanded to the expanded configuration with the balloon inside a patient's body;
wherein the first row of struts forms exactly twelve crowns at the inflow end of the frame.

14. The assembly of claim 13 , wherein the frame further comprises a fourth row of circumferential struts downstream of the first row and upstream of the second row.

15. The assembly of claim 14 , wherein the row of cells defined between the second and third row of struts is a first row of cells, the second row of struts and the fourth row of struts define a second row of cells upstream of the first row of cells, and the fourth row of struts and the first row of struts define a third row of cells upstream of the second row of cells.

16. The assembly of claim 13 , wherein each commis sure attachment post is connected to adjacent ends of two struts of the second row of struts at a junction and extends from the junction toward the outflow end of the frame.

17. An assembly comprising:
a delivery catheter comprising a balloon; and
an implantable prosthetic heart valve that is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration, the prosthetic heart valve comprising:
a radially collapsible and expandable annular frame, the frame having three commissure attachment posts and at least three rows of circumferential struts including a first row of circumferential struts defining an inflow end of the frame, a second row of circumferential struts downstream of the first row, and a third row of circumferential struts spaced downstream of the second row and defining an outflow end of the frame, each row of circumferential struts comprising angled struts arranged in a zig-zag pattern, wherein the second and third row of struts define a row of cells defining openings in the frame along an outflow portion of the frame;
a leaflet structu

Assignees

• Edwards Lifesciences Corp

Inventors

• Hariton Ilia
• Benichou Netanel
• Nitzan Yaacov
• Felsen Bella
• Nguyen-Thien-Nhon Diana
• Khanna Rajesh A
• Nguyen Son V
• Levi Tamir S
• Pelled Itai

Classifications

• B05B1/185

  characterised by their outlet element; Mounting arrangements therefor · CPC title

• A61F2/2433

  using balloon catheter · CPC title

• A61F2230/0054

  V-shaped · CPC title

• Y10T29/49863

  with prestressing of part · CPC title

• A61F2/2418 Primary

  Scaffolds therefor, e.g. support stents · CPC title