Perivalvular sealing for transcatheter heart valve

Patent metadata

Field	Value
Publication number	US-10966825-B2
Application number	US-201916548659-A
Country	US
Kind code	B2
Filing date	Aug 22, 2019
Priority date	Jul 15, 2011
Publication date	Apr 6, 2021
Grant date	Apr 6, 2021

Abstract

A prosthetic heart valve includes a collapsible and expandable annular frame. The frame includes a plurality of rows of hexagonal cells. Each of the hexagonal cells is defined by six struts, including: two opposing side struts extending parallel to each other, a first pair of angled struts extending from respective first ends of the side struts and converging to intersect with each other, and a second pair of angled struts extending from respective second ends of the side struts and converging to intersect with each other. The prosthetic heart valve can also include a valvular structure with a plurality of leaflets. The prosthetic heart valve can further include a sealing member.

First claim

We claim:

1. A balloon-expandable prosthetic heart valve comprising:
a collapsible and expandable annular frame having an inflow end, an outflow end, and a longitudinal axis extending from the inflow end to the outflow end, wherein the frame comprises a nickel-cobalt-chromium alloy and a plurality honeycomb-shaped hexagonal cells, wherein the hexagonal cells are arranged in a plurality of rows, including two homogenous rows disposed adjacent the inflow end of the frame, and wherein each of the hexagonal cells is defined by six struts, including:
two opposing side struts extending parallel to each other;
a first pair of angled struts extending from respective first ends of the side struts and converging to intersect with each other to form an inflow-directed apex that is disposed toward the inflow end of the frame relative to the first ends of the side struts, and wherein the inflow-directed apex includes a U-shaped portion at the intersection of the first pair of angled struts; and
a second pair of angled struts extending from respective second ends of the side struts and converging to intersect with each other to form an outflow-directed apex that is disposed toward the outflow end of the frame relative to the second ends of the side struts, and wherein the outflow-directed apex includes a U-shaped portion at the intersection of the second pair of angled struts,
wherein the U-shaped portion of the inflow-directed apex and the U-shaped portions of the outflow-directed apex each comprise a first side, a second side, and a third side, wherein the first side and the second side are directly coupled to a respective pair of angled struts and extend axially from the respective pair of angled struts parallel to the longitudinal axis, and wherein the third side of each U-shaped portion and is directly coupled to the first side and the second side and extends perpendicular to the first side, the second side, and the longitudinal axis.

2. The prosthetic heart valve of claim 1 , wherein the frame has a height of about 20 mm measured from an inflow end of the frame to an outflow end of the frame when the frame is in an expanded state.

3. The prosthetic heart valve of claim 1 , further comprising a leaflet structure coupled to the frame, wherein the leaflet structure comprises a plurality of leaflets.

4. The prosthetic heart valve of claim 1 , further comprising a sealing skirt coupled to the frame.

5. The prosthetic heart valve of claim 4 , wherein each leaflet has a scalloped lower edge portion that is secured to the sealing skirt by sutures.

6. The prosthetic heart valve of claim 4 , wherein the sealing skirt comprises polyethylene terephthalate or ultra-high molecular weight polyethylene.

7. The prosthetic heart valve of claim 4 , wherein the sealing skirt covers at least the two homogenous rows.

8. The prosthetic heart valve of claim 4 , wherein the sealing skirt covers the two homogenous rows but does not cover any other row.

9. The prosthetic heart valve of claim 4 , wherein the sealing skirt is positioned on an outside of the frame.

10. The prosthetic heart valve of claim 4 , wherein the sealing skirt is a first sealing skirt disposed on an outside of the frame, and wherein the prosthetic heart valve further comprises a second sealing skirt disposed on an inside side of the frame.

11. A balloon-expandable prosthetic heart valve comprising:
an annular frame having an inflow end, an outflow end, and a longitudinal axis extending from the inflow end to the outflow end, wherein the frame comprises exactly three rows of hexagonal cells, and wherein each of the hexagonal cells includes:
two opposing side struts that are spaced apart from each other and extend parallel to the longitudinal axis;
a first pair of angled struts extending from respective first ends of the side struts and converging to intersect with each other, wherein an intersection of the first pair of angled struts is directed toward the inflow end and includes a U-shape portion; and
a second pair of angled struts extending from respective second ends of the side struts and converging to intersect with each other, wherein an intersection of the second pair of angled struts is directed toward the outflow end and includes a U-shape portion,
wherein each of the U-shaped portions at the inflow end of the frame and each of the U-shaped portions at the outflow end of the frame comprise a first side, a second side, and a third side, wherein the first side and the second side extend from a respective pair of angled struts and extend parallel to the longitudinal axis, and wherein the third side extends perpendicular to the first side, the second side, and the longitudinal axis and is axially spaced apart from the respective pair of angled struts by the first side and the second side of the U-shaped portion; and

a valvular structure coupled to the frame and comprising exactly three leaflets.

12. The prosthetic heart valve of claim 11 , wherein each leaflet has a tab portion adjacent a free edge of the leaflet, and wherein the tab portion is coupled to the frame at a location adjacent the outflow end of the frame.

13. The prosthetic heart valve of claim 12 , further comprising one or more reinforcement strips disposed between the tab portion of each leaflet and the frame.

14. The prosthetic heart valve of claim 12 , further comprising a sealing member coupled to the frame, wherein the sealing member comprises polyethylene terephthalate or ultra-high molecular weight polyethylene.

15. The prosthetic heart valve of claim 14 , wherein each leaflet has a scalloped edge portion opposite the free edge, and wherein the scalloped edge portion is secured to the sealing member by sutures.

16. The prosthetic heart valve of claim 15 , wherein the frame comprises a nickel-cobalt-chromium-molybdenum alloy.

17. A balloon-expandable prosthetic heart valve comprising:
a frame having an upper end and a lower end, wherein the frame can be plastically deformed from a radially compressed state to a radially expanded state, wherein the frame comprises exactly four rows of angled struts, wherein the angled struts joined to each other so as to form exactly three rows of hexagonal cells, wherein each row of hexagonal cells extends circumferentially around the frame, and wherein each of the hexagonal cells comprises:
two opposing side struts that are spaced apart from each other and extend parallel to each other;
a lower pair of angled struts extending from respective first ends of the side struts and converging to intersect with each other, wherein an intersection of the first pair of angled struts is directed toward the lower end; and
a second pair of angled struts extending from respective second ends of the side struts and converging to intersect with each other, wherein an intersection of the second pair of angled struts is directed toward the upper end,
wherein the lower end of the frame comprises U-shaped portions at the intersection of the first pair of angled struts and the upper end of the frame comprise U-shaped portions at the intersection of the second pair of angled struts, and
wherein the U-shaped portions at the lower end and the upper end of the frame comprise a first side, a second side, and a third side, wherein the first side and the second side are disposed between the third side and a respective pair of angled struts and extend parallel to a central longitudinal axis which extends from the lower end to the upper end of the frame, and wherein the third side extends perpendicular to the first side, the second side, and the central lon

Assignees

• Edwards Lifesciences Corp

Inventors

• Yohanan Ziv
• Gurovich Nikolay
• Felsen Bella
• Pelled Itai
• Meiri Oded

Classifications

• A61F2/2433

  using balloon catheter · CPC title

• A61F2/2418 Primary

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

• A61F2230/0054

  V-shaped · CPC title

• A61F2250/0065

  telescopic · CPC title

• A61F2250/0069

  Sealing means · CPC title