Coverings for a prosthetic heart valve

Patent metadata

Field	Value
Publication number	US-2025248810-A1
Application number	US-202519190479-A
Country	US
Kind code	A1
Filing date	Apr 25, 2025
Priority date	Nov 18, 2022
Publication date	Aug 7, 2025
Grant date	—

Abstract

Coverings and/or skirts for prosthetic heart valves are disclosed. As an example, a prosthetic heart valve comprises a frame comprising three axially extending commissure support portions, a plurality of rows of angled struts including a first row defining an inflow end, a second row downstream of the first row, and a third row downstream of the second row and defining an outflow end, where downstream ends of the struts of the second row are connected to each other at junctions, and the commissure support portions extend from respective junctions to the third row of struts. The valve further comprises leaflets forming three commissures secured to respective commissure support portions, and an outer skirt comprising an outflow edge forming three circumferentially spaced projections aligned with the commissure support portions and covering respective junctions, the outflow edge comprising straight sections extending between adjacent projections upstream of the junctions.

First claim

We claim:

1 . A prosthetic heart valve comprising:
a radially expandable and compressible frame comprising three axially extending commissure support portions and a plurality of rows of angled struts including a first row of angled struts defining an inflow end of the frame, a second row of angled struts downstream of the first row of angled struts, and a third row of angled struts downstream of the second row of angled struts and defining an outflow end of the frame; wherein downstream ends of the angled struts of the second row of angled struts are connected to each other at a plurality of junctions; wherein the commissure support portions extend from respective junctions of the plurality of junctions of the second row of angled struts to the third row of angled struts; a plurality of leaflets forming three commissures secured to respective commissure support portions of the frame; and an outer skirt disposed around an outer surface of the frame and comprising an inflow edge and an outflow edge, wherein the outflow edge forms three circumferentially spaced projections aligned with the commissure support portions and covering respective junctions of the second row of angled struts, the outflow edge further comprising circumferentially extending sections extending between adjacent projections, wherein the circumferentially extending sections are located upstream of the junctions of the second row of angled struts.

2 . The prosthetic heart valve of claim 1 , wherein each projection is shaped to cover the downstream ends of a respective pair of angled struts of the second row of angled struts and a respective junction.

3 . The prosthetic heart valve of claim 2 , wherein each projection is shaped as an acute trapezoid that widens from a downstream end of the projection to the circumferentially extending sections.

4 . The prosthetic heart valve of claim 2 , wherein each projection is secured to the downstream ends of the respective pair of angled struts of the second row of angled struts and the respective junction with one or more stitches.

5 . The prosthetic heart valve of claim 1 , wherein the outer skirt is attached to the frame along a portion of angled struts of the first row of angled struts, the second row of angled struts, and a fourth row of angled struts disposed between the first and second rows of angled struts with sutures, the portion of angled struts extending from one commissure support portion to the inflow end of the frame and from the inflow end to an adjacent commissure support portion.

6 . The prosthetic heart valve of claim 5 , wherein each projection is attached to a respective commissure support portion by one or more stitches.

7 . The prosthetic heart valve of claim 1 , wherein the inflow edge of the outer skirt comprises three circumferentially spaced cutouts that are aligned with the projections and that are shaped to follow a shape of angled struts of the first row of angled struts, and wherein each cutout is shaped such that the inflow edge extends toward the outflow edge from straight portions of the inflow edge that are disposed on both sides of the cutout.

8 . The prosthetic heart valve of claim 1 , wherein the outer skirt comprises a stretchable fabric or polymeric material.

9 . The prosthetic heart valve of claim 8 , wherein the three projections are formed by stretching the outflow edge of the outer skirt, at regions adjacent to the commissure support portions, over the respective junctions and attaching the stretched projections to the respective commissure support portions with one or more stitches.

10 . A prosthetic heart valve comprising:
a radially expandable and compressible frame comprising three commissure support portions and a plurality of rows of angled struts including a first row of angled struts defining an inflow end of the frame, a second row of angled struts downstream of the first row of angled struts, and a third row of angled struts downstream of the second row of angled struts and defining an outflow end of the frame; wherein downstream ends of the angled struts of the second row of angled struts are connected to each other at a plurality of junctions; a plurality of leaflets forming three commissures secured to respective commissure support portions of the frame, wherein upstream edges of the commissures are located adjacent respective junctions of the second row of struts; and an outer skirt disposed around an outer surface of the frame and comprising an inflow edge and an outflow edge, wherein the outflow edge forms three circumferentially spaced projections aligned with the commissure support portions and covering respective junctions of the second row of angled struts, the outflow edge further comprising straight sections extending between adjacent projections, wherein the straight sections are located upstream of the junctions of the second row of angled struts.

11 . The prosthetic heart valve of claim 10 , wherein each projection is shaped to cover the downstream ends of a respective pair of angled struts of the second row of angled struts and a respective junction.

12 . The prosthetic heart valve of claim 11 , wherein each projection is A-shaped and widens from a downstream end of the projection to the straight sections, and wherein the downstream end of the projection is disposed adjacent to a respective commissure support portion.

13 . The prosthetic heart valve of claim 10 , wherein the outer skirt is attached to the frame along a portion of angled struts of the first row of angled struts, the second row of angled struts, and a fourth row of angled struts disposed between the first and second rows of angled struts with sutures, the portion of angled struts extending from a first commissure support portion to the inflow end of the frame and from the inflow end to an adjacent, second commissure support portion.

14 . A prosthetic heart valve comprising:
a frame comprising a plurality of interconnected struts; an inner skirt disposed around an inner surface of the frame and comprising:
an inflow edge portion and an outflow edge portion; and
opposing first and second edge portions that each extend between the inflow edge portion and the outflow edge portion and are non-perpendicular to the inflow edge portion, wherein the first and second edge portions overlap one another to form an annular configuration of the inner skirt inside the frame;
a plurality of leaflets arranged inside the frame, wherein a cusp edge portion of a first leaflet of the plurality of leaflets is arranged along the overlapping first and second edge portions; and a plurality of stitches securing the overlapping first and second edge portions and the cusp edge portion of the first leaflet to one another.

15 . The prosthetic heart valve of claim 14 , wherein the plurality of interconnected struts of the frame form a plurality of rows of angled struts, and wherein the inner skirt is secured to a portion of angled struts of the plurality of rows of angled struts.

16 . The prosthetic heart valve of claim 14 , wherein the first and second edge portions each comprise a single row of spaced apart apertures that extend through a material of the inner skirt, wherein the first and second edge portions overlap one another with their respective apertures overlapping one another, and wherein the plurality of stitches are in-and-out stitches that extend through the overlapping apertures of the first and second edge portions, and the cusp edge portion of the first leaflet.

17 . The prosthetic heart valve of claim 14 , wherein t

Assignees

• Edwards Lifesciences Corp

Inventors

• Shitrit Roy
• Dalbow Brendan Michael
• Gurovich Nikolai
• Levi Tamir S
• Sherman Elena
• Katz Maya

Classifications

• A61F2220/0075

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

• A61F2210/0076

  multilayered, e.g. laminated structures · CPC title

• A61F2/91

  made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes · CPC title

• A61F2/90

  characterised by a net-like or mesh-like structure · CPC title

• A61F2/2433

  using balloon catheter · CPC title