Leaflet frame attachment for prosthetic valves

Patent metadata

Field	Value
Publication number	US-12059344-B2
Application number	US-202117183014-A
Country	US
Kind code	B2
Filing date	Feb 23, 2021
Priority date	Sep 12, 2017
Publication date	Aug 13, 2024
Grant date	Aug 13, 2024

Abstract

Described embodiments are directed toward centrally-opening leaflet prosthetic valves having a frame and a leaflet construct. Leaflet frame attachments for prosthetic valves include the leaflet construct being at least partially coupled to a frame outer side by a looped structure.

First claim

What is claimed is:

1. A prosthetic valve comprising:
a leaflet construct including a first leaflet;
a first retaining element coupled to the first leaflet;
a second retaining element coupled to the first leaflet; and
a frame having an inlet end, an outlet end, and a central longitudinal axis extending from the inlet end to the outlet end, and a slot operable to receive a portion of the first leaflet therethrough such that the first leaflet defines a first outer loop portion on an outer side of the frame and a first inner loop portion on an inner side of the frame, wherein a portion of the first retaining element is received within the first outer loop portion and wherein a portion of the second retaining element is received within the first inner loop portion;
wherein the first outer loop portion encircles the portion of the first retaining element, and the first inner loop portion encircles the portion of the second retaining element; and
wherein the portion of the first retaining element extends along a first single axis in a direction parallel to the central longitudinal axis from an upper end of the first outer loop portion to a lower end of the first outer loop portion entirely within the first outer loop portion, and wherein the portion of the second retaining element extends along a second single axis in a direction parallel to the central longitudinal axis from an upper end of the first inner loop portion to a lower end of the first inner loop portion entirely within the first inner loop portion.

2. The prosthetic valve of claim 1 , wherein the frame further includes a projection over which the first retaining element is received to axially support the leaflet construct.

3. The prosthetic valve of claim 2 , wherein the leaflet construct includes a second leaflet and a bridge interconnecting the first and the second leaflets, wherein the bridge hangs over the projection.

4. The prosthetic valve of claim 1 , wherein the first leaflet includes a body portion, a first tab portion extending from a first side of the body portion to a terminal end, and a second tab portion extending from a second side of the body portion to a terminal end, the first tab portion forming the first inner loop portion and the first outer loop portion and the terminal end of the first tab portion is positioned outside side of the frame.

5. The prosthetic valve of claim 1 , wherein the slot is a closed slot or where the slot extends from an open end to a closed end.

6. The prosthetic valve of claim 1 , wherein the slot is formed through the frame in a radial direction relative to the central longitudinal axis of the frame or the slot is formed at an angle to a radial direction relative to the central longitudinal axis of the frame.

7. The prosthetic valve of claim 1 , wherein tension on the first leaflet reduces a width of the slot.

8. The prosthetic valve of claim 1 , wherein a cross-sectional area of the first retaining element and the first outer loop portion is greater than a width of the slot.

9. The prosthetic valve of claim 1 , wherein the first leaflet defines a plurality of attachment tabs around a perimeter of the first leaflet that extend over the frame and coupled to the outer side of the frame.

10. The prosthetic valve of claim 9 , wherein each of the attachment tabs is separated from an adjacent attachment tab by an opening for receiving a portion of the frame and optionally wherein the attachment tabs of the first leaflet each include a plurality of apertures.

11. The prosthetic valve of claim 1 , wherein the frame defines a plurality of commissure posts each including a first post leg and a second post leg that are spaced to define the slot.

12. The prosthetic valve of claim 11 , wherein the leaflet construct includes a plurality of leaflets interconnected with one another by a plurality of bridges that pass through the slots of the commissure posts.

13. The prosthetic valve of claim 1 , wherein the frame includes a plurality of frame elements that define a plurality of leaflet attachment regions each having a shape of an isosceles trapezoid having two leaflet attachment region sides diverging from a leaflet base.

14. The prosthetic valve of claim 13 , wherein the leaflet base is perpendicular to the frame central longitudinal axis.

15. The prosthetic valve of claim 1 , wherein the leaflet construct comprises at least one expanded fluoropolymer membrane layer.

16. The prosthetic valve of claim 15 , wherein a second material is contained within a porous structure of the expanded fluoropolymer membrane layer, coated on one or both sides of the expanded fluoropolymer membrane layer, or a combination of coated on and contained within the expanded fluoropolymer membrane layer.

17. The prosthetic valve of claim 1 , wherein the leaflet construct comprises a composite having more than one fluoropolymer membrane layer.

18. The prosthetic valve of claim 1 , wherein the frame comprises a shape memory metal, stainless steel, and/or a nickel-titanium alloy.

19. The prosthetic valve of claim 1 , wherein the leaflet construct comprises a fluoropolymer membrane layer including ePTFE.

20. The prosthetic valve of claim 1 , wherein the leaflet construct defines a continuous annular ring.

21. The prosthetic valve of claim 1 , wherein the first leaflet has a first tab portion and a second tab portion and the leaflet construct includes a second leaflet with a first tab portion and a second tab portion;
wherein the first tab portion of the first leaflet defines a first pass, a second pass, and a third pass through the slot, the first pass and the second pass of the first tab portion of the first leaflet forming the first outer loop portion and the second pass and third pass of the first tab portion of the first leaflet forming the first inner loop portion;
wherein the second tab portion of the second leaflet defines a first pass, a second pass, and a third pass through the slot, the first pass and the second pass of the second tab portion of the second leaflet forming a second outer loop portion and the second pass and third pass of the second tab portion of the second leaflet forming a second inner loop portion; and
wherein the first outer loop portion and the second outer loop portion are arranged adjacent to each other on the outer side of the frame and the first inner loop portion and the second inner loop portion are arranged adjacent to each other on the inner side of the frame.

22. The prosthetic valve of claim 21 , wherein the portion of the first retaining element encircled by the first outer loop portion comprises a first portion, and the first retaining element comprises a second portion that extends through the second outer loop portion.

23. A prosthetic valve comprising:
a leaflet construct including a first leaflet having a body portion, a first tab portion extending from the body portion, and a second tab portion extending from the body portion opposite to the first tab portion, wherein the body portion, the first tab portion and the second tab portion are formed from a single, continuous piece of material;
a first retaining element coupled to the first leaflet; and
a frame having a central longitudinal axis and a slot through which the first tab portion extends multiple times, including a first pass, a second pass, and a third pass through the slot.

24. The prosthetic valve of claim 23 , wherein the first pass and the third pass are coupled and po

Assignees

• Edwards Lifesciences Corp

Inventors

• Arcaro David J
• Probert Stephen M
• Dienno Dustin V
• Hartman Cody L

Classifications

• A61F2230/0054

  V-shaped · CPC title

• A61F2220/0025

  Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements · CPC title

• A61F2/2415

  Manufacturing methods · CPC title

• A61F2/2466

  Delivery devices therefor · CPC title

• A61F2/246

  Devices for obstructing a leak through a native valve in a closed condition · CPC title