Perivalvular sealing for transcatheter heart valve

Patent metadata

Field	Value
Publication number	US-12502273-B2
Application number	US-202117235230-A
Country	US
Kind code	B2
Filing date	Apr 20, 2021
Priority date	Jul 15, 2011
Publication date	Dec 23, 2025
Grant date	Dec 23, 2025

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, the longitudinal axis defining an axial direction of the frame, the frame having a honeycomb structure comprising a plurality of hexagonal cells adjoined by a plurality of side struts extending in the axial direction; wherein the hexagonal cells are arranged in a plurality of rows between the inflow end and the outflow end; wherein each of the hexagonal cells comprises a pair of first angled struts and a pair of second angled struts, wherein each of the first angled struts form a first angle relative to the longitudinal axis; wherein each of the side struts has a first end and a second end and forms a common strut between two adjacent hexagonal cells; and wherein a plurality of first U-shaped grooves are disposed circumferentially about the frame, each of the first U-shaped grooves formed at an intersection between the first end of one of the side struts and two first angled struts from two adjacent hexagonal cells, wherein each of the first U-shaped grooves comprises two side walls spaced apart from each other and forming a second angle relative to the longitudinal axis, wherein the first angle is different than the second angle.

2 . The balloon-expandable prosthetic heart valve of claim 1 , wherein a plurality of second U-shaped grooves are disposed circumferentially about the frame, each of the second U-shaped grooves formed at an intersection between the second end of one of the side struts and two second angled struts from two adjacent hexagonal cells.

3 . The balloon-expandable prosthetic heart valve of claim 2 , wherein first and second U-shaped grooves are formed at the first and second ends, respectively, of each of the side struts in at least one of the plurality of rows.

4 . The balloon-expandable prosthetic heart valve of claim 2 , wherein the first angled struts of the hexagonal cells in a first row of the plurality of rows form a plurality of first apices that are oriented towards the outflow end, and wherein the first U-shaped grooves in the first row are axially offset from the first apices.

5 . The balloon-expandable prosthetic heart valve of claim 4 , wherein the second angled struts of the hexagonal cells in a last row of the plurality of rows form a plurality of second apices that are oriented towards the inflow end, and wherein the second U-shaped grooves in the last row are axially offset from the second apices.

6 . The balloon-expandable prosthetic heart valve of claim 4 , wherein the first angled struts of the hexagonal cells in the first row form a plurality of other U-shaped grooves at the plurality of first apices.

7 . The balloon-expandable prosthetic heart valve of claim 1 , wherein the angled struts have a curved shape.

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

9 . The balloon-expandable prosthetic heart valve of claim 8 , further comprising a sealing skirt coupled to the frame.

10 . The balloon-expandable prosthetic heart valve of claim 9 , wherein each leaflet has a scalloped lower edge portion that is secured to the sealing skirt by sutures.

11 . The balloon-expandable prosthetic heart valve of claim 9 , wherein the sealing skirt comprises polyethylene terephthalate or ultra-high molecular weight polyethylene.

12 . The balloon-expandable prosthetic heart valve of claim 9 , wherein the sealing skirt covers at least two rows of the plurality of rows.

13 . The balloon-expandable prosthetic heart valve of claim 1 , wherein the frame comprises a nickel-cobalt-chromium alloy.

14 . The balloon-expandable prosthetic heart valve of claim 1 , wherein the plurality of hexagonal cells is arranged in exactly three rows between the inflow end and the outflow end.

15 . 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, the longitudinal axis defining an axial direction of the frame, the frame comprising a plurality of honeycomb-shaped hexagonal cells, wherein the plurality of honeycomb-shaped hexagonal cells are arranged in a plurality of rows between the inflow end and the outflow end, wherein the hexagonal cells in a first row of the plurality of rows define a plurality of first apices that are oriented towards the outflow end, wherein the hexagonal cells in a last row of the plurality of rows define a plurality of second apices that are oriented towards the inflow end and a plurality of U-shaped grooves, each of the U-shaped grooves are formed at each common strut of two adjacent hexagonal cells and extend in the axial direction from a first end of the common strut towards a second end of the common strut along a length of the common strut, the U-shaped grooves are also formed at each of the plurality of first apices and each of the plurality of second apices and extend in the axial direction along each the first and second apices; wherein each of the hexagonal cells comprises angled struts wherein each of the angled struts forms a first angle relative to the longitudinal axis; wherein each of the U-shaped grooves comprises two side walls spaced apart from each other and forming a second angle relative to the longitudinal axis, wherein the first angle is different than the second angle, a leaflet structure coupled to the frame, the leaflet structure comprising a plurality of leaflets; and a sealing skirt coupled to the frame.

16 . The balloon-expandable prosthetic heart valve of claim 15 , wherein the sealing skirt is disposed at least partly on an inner side of the frame, wherein the sealing skirt covers the hexagonal cells in at least two rows of the plurality of rows, and wherein the sealing skirt protrudes outwardly through the hexagonal cells.

Assignees

• Edwards Lifesciences Corp

Inventors

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

Classifications

• A61F2230/0054

  V-shaped · CPC title

• A61F2220/0075

  sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable · CPC title

• A61F2250/0069

  Sealing means · CPC title

• A61F2/2436

  Deployment by retracting a sheath · CPC title

• A61F2250/0065

  telescopic · CPC title