Prosthetic valve with expandable frame and associated systems and methods

Patent metadata

Field	Value
Publication number	US-11020221-B2
Application number	US-201816129647-A
Country	US
Kind code	B2
Filing date	Sep 12, 2018
Priority date	Sep 27, 2017
Publication date	Jun 1, 2021
Grant date	Jun 1, 2021

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 including a decreasing diameter in a distal direction between the distal end and the proximal end, the diametric taper defining a taper angle relative to the central longitudinal axis of the frame when the prosthetic valve is in an unloaded state, the diametric taper including a proximal taper, a distal taper, and an intermediate taper between the distal taper and the proximal taper, the distal taper having a greater taper angle than a taper angle of the intermediate taper when the prosthetic valve is in the compact delivery configuration; 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.

2. The prosthetic valve of claim 1 , wherein the taper angle is constant from the distal end to the proximal end when the prosthetic valve is in a diametrically expanded state.

3. The prosthetic valve of claim 1 , wherein the taper angle varies from the distal end to the proximal end when the prosthetic valve is in a diametrically expanded state.

4. The prosthetic valve of claim 1 , wherein the diametric taper includes a proximal taper, a distal taper, and an intermediate taper between the distal taper and the proximal taper, and further wherein the distal taper has a greater taper angle than a taper angle of the intermediate taper when the prosthetic valve is in a diametrically expanded state.

5. The prosthetic valve of claim 4 , wherein the plurality of commissure posts defines the distal taper of the diametric taper when the prosthetic valve is in a diametrically expanded state.

6. The prosthetic valve of claim 1 , wherein the diametric taper includes a proximal taper, a distal taper, and an intermediate taper between the distal taper and the proximal taper, and further wherein the intermediate taper has a greater taper angle than a taper angle of the proximal taper when the prosthetic valve is in a diametrically expanded state.

7. The prosthetic valve of claim 1 , wherein the diametric taper includes a proximal taper, a distal taper, and an intermediate taper between the distal taper and the proximal taper, and further wherein a taper angle of the distal taper is greater than a taper angle of the proximal taper when the prosthetic valve is in a diametrically expanded state.

8. 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.

9. 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.

10. 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.

11. The prosthetic valve of claim 10 , 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.

12. 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.

13. 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, in the range of between 10-90 degrees.

14. 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, in the range of between 10-90 degrees.

15. 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, in the range of between 10-90 degrees.

16. 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.

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

18. The prosthetic valve of claim 1 , further comprising a sealing cuff including a sealing member having a portion that is secured circumferentially about the su

Assignees

• Gore & Ass

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

• A61F2250/0069

  Sealing means · CPC title

• A61F2250/0039

  differing in diameter · CPC title

• A61F2230/0069

  cylindrical · CPC title

• A61F2230/0067

  conical · CPC title

• A61F2230/0054

  V-shaped · CPC title