Prosthetic valve with expandable frame and associated systems and methods

Patent metadata

Field	Value
Publication number	US-11857412-B2
Application number	US-202117333620-A
Country	US
Kind code	B2
Filing date	May 28, 2021
Priority date	Sep 27, 2017
Publication date	Jan 2, 2024
Grant date	Jan 2, 2024

Abstract

Aspects of the disclosure relate to prosthetic valves having a frame, a frame cover, and a leaflet construct. Some aspects are directed to a diametric taper for the prosthetic valve for achieving enhanced performance of the prosthetic valve under operational conditions, enhanced compressibility and delivery characteristics, and other additional or alternative advantages. Other aspects are directed toward unique assembly and attachment methods for securing leaflet constructs to support structures. Other aspects are directed toward features for interacting with transcatheter delivery systems. Still other aspects are directed to such apparatuses, systems, and methods for valve replacement, such as cardiac valve replacement.

First claim

What is claimed is:

1. A prosthetic valve configured to be diametrically collapsible into a compact delivery configuration, the prosthetic valve comprising:
a support structure having an outer side and an inner side and a central longitudinal axis and including a frame including a plurality of frame members and a plurality of commissure posts, the frame extending from a distal end to a proximal end, the distal end having a first diameter and the proximal end having a second larger diameter such that the frame has a diametric taper defining a decrease in diameter in a distal direction between the distal end and the proximal end, the diametric taper including a proximal taper, a distal taper, and an intermediate taper between the distal taper and the proximal taper, the proximal taper defining a proximal taper angle relative to the central longitudinal axis of the frame when the prosthetic valve is in an unloaded state, the intermediate taper defining an intermediate taper angle relative to the central longitudinal axis of the frame when the prosthetic valve is in an unloaded state, and the distal taper defining a distal taper angle relative to the central longitudinal axis of the frame when the prosthetic valve is in an unloaded state, the proximal taper angle being different from the intermediate taper angle and the distal taper angle being different than the intermediate taper angle; and
a leaflet construct including a plurality of leaflets spaced circumferentially about the leaflet construct, the plurality of leaflets being operatively coupled to the frame;
wherein the distal taper angle is greater than the intermediate taper angle when the prosthetic valve is in an unloaded state.

2. The prosthetic valve of claim 1 , wherein the plurality of commissure posts defines the distal taper of the diametric taper.

3. The prosthetic valve of claim 1 , wherein the plurality of frame members extend distally to a frame member distal boundary and the plurality of commissure posts extend distally to a commissure post distal boundary, and further wherein the commissure post distal boundary is located distal to the frame member distal boundary.

4. The prosthetic valve of claim 1 , wherein the plurality of frame members extend distally to a frame member distal boundary and the plurality of leaflets extend distal to the frame member distal boundary.

5. The prosthetic valve of claim 1 , wherein the plurality of frame members define a plurality of rows of closed cells, including a distal row of closed cells and a proximal row of closed cells located proximal to the distal row of closed cells, wherein each of the closed cells of the distal row of closed cells defines a cell height between a distal end and a proximal end of the closed cell, wherein each of the closed cells of the proximal row of closed cells defines a cell height between a distal end and a proximal end of the closed cell, and further wherein the cell heights of the distal row of closed cells are each less than the cell heights of the proximal row of closed cells.

6. The prosthetic valve of claim 5 , wherein the plurality of rows of closed cells defined by the plurality of frame members further includes an intermediate row of closed cells located intermediate the proximal row of closed cells and the distal row of closed cells, wherein each of the closed cells of the intermediate row of closed cells defines a cell height between a distal end and a proximal end of the closed cell, and further wherein the cell heights of the intermediate row of closed cells are less than the cell heights of the proximal row of closed cells and greater than the cell heights of the distal row of closed cells.

7. The prosthetic valve of claim 1 , wherein the plurality of frame members define a plurality of rows of closed cells, including a distal row of closed cells and a proximal row of closed cells located proximal to the distal row of closed cells, wherein each of the closed cells of the distal row of closed cells includes at least two proximal-facing apices.

8. The prosthetic valve of claim 1 , wherein the plurality of frame members define a plurality of rows of distal-facing apices, wherein each of the distal-facing apices defines an apex angle, and wherein each of the apex angles of each of the distal-facing apices of each of the rows of distal-facing apices has an apex angle that is within 10% of a common apex angle.

9. The prosthetic valve of claim 1 , wherein the plurality of frame members define a plurality of rows of proximal-facing apices, wherein each of the proximal-facing apices defines an apex angle, and wherein each of the apex angles of each of the proximal-facing apices of each of the rows of proximal-facing apices has an apex angle that is within 10% of a common apex angle.

10. The prosthetic valve of claim 1 , wherein the plurality of frame members defines a column of distal-facing apices and proximal-facing apices, each of the distal-facing apices and the proximal-facing apices defining apex angles within 10% of a common apex angle.

11. The prosthetic valve of claim 1 , wherein each of the leaflets of the leaflet construct extends distally from a leaflet base to a free edge, each of the leaflet bases being located at a first longitudinal location along the central longitudinal axis of the support structure, the frame defining a leaflet base level diameter at the first longitudinal location, each of the leaflets being coupled to the plurality of commissure posts at a second longitudinal location along the central longitudinal axis of the support structure that is distal to the first longitudinal location, the frame defining a commissure level diameter at the second longitudinal location, the commissure level diameter being less than the leaflet base level diameter when the prosthetic valve is in an unloaded state and the commissure level diameter being closer in value to the leaflet base diameter when the prosthetic valve is in an operational state than in the unloaded state, the operational state including the prosthetic valve being subjected to an inward radial compressive force on at least a proximal portion of the prosthetic valve.

12. The prosthetic valve of claim 1 , wherein the support structure further comprises a cover secured to the frame.

13. The prosthetic valve of claim 1 , further comprising a sealing cuff including a sealing member having a portion that is secured circumferentially about the support structure and a distal-facing edge, at least a portion of which is not secured to the support structure.

14. The prosthetic valve of claim 13 , wherein the distal-facing edge is secured to the support structure at a plurality of locations and remains unsecured from the support structure at a plurality of locations.

15. The prosthetic valve of claim 1 , wherein each of the leaflets of the leaflet construct extends distally from a leaflet base to a free edge, each of the leaflet bases being substantially flat.

16. The prosthetic valve of claim 1 , further comprising a plurality of constraint retainers secured to the plurality of frame members.

17. The prosthetic valve of claim 16 , further comprising a constraint slidably received by the plurality of constraint retainers.

18. A prosthetic valve configured to be diametrically collapsible into a compact delivery configuration, the prosthetic valve comprising:
a support structure having an outer side and an inner side and a central longitudinal axis and including a frame including a plurality of frame members and a plurality of commissure posts, the frame extending from a dista

Assignees

• Edwards Lifesciences Corp

Inventors

• Arcaro David J
• Derryberry Kevin J
• Dienno Dustin V
• Field Edwin W
• Finney Bill R
• Haarer Joshua C
• Hagaman Logan R
• Hartman Cody L
• Jacoby Russell L
• Manygoats Jr Roy
• Probert Stephen M
• Smith Benjamin A
• Hilton Andrew P
• Baykova Olga
• Alger Jason T

Classifications

• A61F2/2412

  with soft flexible valve members, e.g. tissue valves shaped like natural valves · CPC title

• A61F2/2418 Primary

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

• A61F2/24

  Heart valves {; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body} · CPC title

• A61F2/2433

  using balloon catheter · CPC title

• A61F2/2439

  Expansion controlled by filaments · CPC title