Leaflet frame attachment for prosthetic valves

Patent metadata

Field	Value
Publication number	US-10959842-B2
Application number	US-201816129651-A
Country	US
Kind code	B2
Filing date	Sep 12, 2018
Priority date	Sep 12, 2017
Publication date	Mar 30, 2021
Grant date	Mar 30, 2021

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 frame having a central longitudinal axis, an inner side, and an outer side, the frame including a plurality of frame members and a plurality of commissure posts spaced circumferentially about the frame, the frame defining a plurality of leaflet attachment regions, the plurality of commissure posts including a first commissure post extending in a longitudinal direction and having a first slot formed through the first commissure post in a longitudinal direction, the first slot having a height and a width; and
a leaflet construct including a plurality of leaflets spaced circumferentially about the leaflet construct, the plurality of leaflets including a first leaflet and a second leaflet positioned circumferentially-adjacent to the first leaflet, the first leaflet including a first outer retaining element, a body portion having a first side and a second side, a first commissure tab extending from the first side of the body portion, and a second commissure tab extending from the second side of the body portion, the first commissure tab having a first portion that extends through the first slot and a second portion that extends through the first slot to define a first outer loop portion on the outer side of the frame, the first outer loop portion encircling the first outer retaining element such that the first outer loop portion has a width that is greater than the width of the first slot to secure the first outer loop portion from being pulled through the first slot.

2. The prosthetic valve of claim 1 , wherein the second leaflet includes a second outer retaining element, a body portion having a first side and a second side, a first commissure tab extending from the first side of the body portion, and a second commissure tab extending from the second side of the body portion, the second commissure tab of the second leaflet having a first portion that extends through the first slot and a second portion that extends through the first slot to define a second outer loop portion on the outer side of the frame, the second outer loop portion encircling the second outer retaining element such that the second outer loop portion has a width that is greater than the width of the first slot to secure the second outer loop portion from being pulled through the first slot.

3. The prosthetic valve of claim 1 , wherein the first commissure post has a second slot formed through the first commissure post in a longitudinal direction, the second slot having a height and a width, and further wherein the second leaflet includes a second outer retaining element, a body portion having a first side and a second side, a first commissure tab extending from the first side of the body portion, and a second commissure tab extending from the second side of the body portion, the second commissure tab of the second leaflet having a first portion that extends through the second slot and a second portion that extends through the second slot to define a second outer loop portion on the outer side of the frame, the second outer loop portion encircling the second outer retaining element such that the second outer loop portion has a width that is greater than the width of the second slot to secure the second outer loop portion from being pulled through the second slot.

4. The prosthetic valve of claim 3 , wherein the first and second outer retaining elements are continuous to define a continuous outer retaining element extending between the first and second leaflets.

5. The prosthetic valve of claim 4 , wherein the first commissure post further includes a hanging feature over which the outer continuous retaining element is hung to axially support the leaflet construct relative to the frame.

6. The prosthetic valve of claim 1 , wherein the first leaflet further includes a first inner retaining element and the first commissure tab of the first leaflet further defines a first inner loop portion on the inner side of the frame, the first inner loop portion encircling the first inner retaining element such that the first inner loop portion has a width that is greater than the width of the first slot to secure the first inner loop portion from being pulled through the first slot.

7. The prosthetic valve of claim 6 , wherein at least one of the first inner retaining element and the first outer retaining element is formed of one or more of a strand, a suture, a thread, a monofilament, a multifilament, a wire, one or more folds of material, a plurality of layers of material, and a bead of material.

8. The prosthetic valve of claim 6 , wherein the first inner retaining element and the first outer retaining element are continuously formed with one another to define a continuous retaining element.

9. The prosthetic valve of claim 1 , wherein the leaflet construct includes a bridge interconnecting the first and second leaflets.

10. The prosthetic valve of claim 1 , wherein the leaflet includes a polymeric membrane and the first outer retaining element is coupled to the polymeric membrane by being molded, adhered and/or bonded to the polymeric membrane.

11. The prosthetic valve of claim 1 , wherein each leaflet of the plurality of leaflets defines a free edge and further wherein each leaflet is attached to the frame such that adjacent leaflets have adjacent free edges that diverge relative to each other at the frame.

12. A prosthetic valve comprising:
a leaflet construct including a first leaflet and a first retaining element coupled to the first leaflet, the first leaflet defining a tab portion; and
a frame having a slot operable to receive the tab portion of the first leaflet therethrough, the tab portion extending through the slot at least two times and defining a first outer loop portion on an outer side of the frame through which a portion of the first retaining element is received, the frame further including a hanging feature over which the first retaining element is received to axially support the leaflet construct.

13. The prosthetic valve of claim 12 , further comprising a second leaflet, a portion of which is passed through the slot of the frame to define a second outer loop portion.

14. The prosthetic valve of claim 12 , wherein the slot of the frame is a first slot and the frame further defines a second slot adjacent the first slot and the leaflet construct further includes a second leaflet, a portion of which is passed through the second slot of the frame to define a second outer loop portion.

15. The prosthetic valve of claim 12 , wherein the first leaflet defines a tab portion that extends through the slot at least three times, wherein the tab portion defines the outer loop portion and an inner loop portion on an inner side of the frame.

16. The prosthetic valve of claim 15 , wherein the leaflet construct further includes a second retaining element that extends through the inner loop portion.

17. The prosthetic valve of claim 15 , wherein a terminal end of the tab portion is coupled to another part of the tab portion by being molded, adhered and/or bonded to the other part of the tab portion.

18. The prosthetic valve of claim 15 , wherein a terminal end of the tab portion is coupled to another part of the first leaflet by being molded, adhered and/or bonded to the other part of the first leaflet.

19. The prosthetic valve of claim 12 , wherein the first leaflet includes a first tab portion, a second tab portion, and a body portion between the first tab portion and the second tab portion, each of the first and second tab portions having a ter

Assignees

• Gore & Ass

Inventors

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

Classifications

• A61F2/2415

  Manufacturing methods · CPC title

• A61F2220/0025

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

• A61F2230/0054

  V-shaped · CPC title

• A61F2/2433

  using balloon catheter · CPC title

• A61F2210/0014

  using shape memory or superelastic materials, e.g. nitinol · CPC title