Telescoping prosthetic valve with retention element

Patent metadata

Field	Value
Publication number	US-11497601-B2
Application number	US-202016805181-A
Country	US
Kind code	B2
Filing date	Feb 28, 2020
Priority date	Mar 1, 2019
Publication date	Nov 15, 2022
Grant date	Nov 15, 2022

Abstract

An implantable device is disclosed. The device includes a leaflet frame subcomponent and an anchor frame subcomponent that are configured to be delivered in a series configuration and subsequently nested or telescoped in-situ.

First claim

What is claimed is:

1. A prosthetic valve transitionable between a delivery configuration and a deployed, nested configuration in-situ, the prosthetic valve comprising:
a leaflet frame subcomponent defining a tubular shape and having a leaflet frame subcomponent wall extending from a leaflet frame subcomponent inflow end and a leaflet frame subcomponent outflow end and the leaflet frame subcomponent defining a leaflet frame subcomponent lumen, the leaflet frame subcomponent including a one-way valve;
an anchor frame subcomponent defining a tubular shape and having an anchor frame subcomponent inflow end and an anchor frame subcomponent outflow end, and the anchor frame subcomponent defining an anchor frame subcomponent lumen;
a connecting sheath defining a tubular shape and having a connecting sheath inflow end coupled to the anchor frame subcomponent outflow end and a connecting sheath outflow end coupled to the leaflet frame subcomponent inflow end coupling the leaflet frame subcomponent to the anchor frame subcomponent, and the connecting sheath defining a connecting sheath lumen; and
a retention element having a retention element first end and a retention element second end, the retention element second end being coupled to the connecting sheath outflow end, the retention element being pivotable about the retention element second end upon translation of the retention element within the anchor frame subcomponent lumen towards the anchor frame subcomponent inflow end, such that the retention element extends from the leaflet frame subcomponent inflow end to the anchor frame subcomponent inflow end;
wherein when the prosthetic valve is in the delivery configuration, the leaflet frame subcomponent and the anchor frame subcomponent are longitudinally offset from one another such that the leaflet frame subcomponent inflow end is situated distal of the anchor frame subcomponent outflow end, wherein the retention element resides within the connecting sheath lumen and extends away from the leaflet frame subcomponent inflow end and substantially parallel with a longitudinal axis of the leaflet frame subcomponent and adjacent to the connecting sheath,
wherein, when the prosthetic valve is in the deployed, nested configuration, the anchor frame subcomponent inflow end flares or tapers radially outward,
wherein, when the prosthetic valve is in the deployed, nested configuration, the connecting sheath is everted and the leaflet frame subcomponent is at least partially nested within the anchor frame subcomponent lumen, the retention element has translated within the anchor frame subcomponent lumen towards the anchor frame subcomponent inflow end, and the retention element is biased outwardly against the anchor frame subcomponent with an outward bias such that the retention element extends from the leaflet frame subcomponent inflow end to the anchor frame subcomponent inflow end, and
wherein the prosthetic valve is transitionable between the delivery configuration and a deployed, nested configuration via an expanded pre-deployed, un-nested configuration.

2. The prosthetic valve of claim 1 , wherein the leaflet frame subcomponent includes a leaflet frame defining a leaflet frame wall, one or more leaflets, and leaflet frame cover, the leaflet frame is generally tubular shaped defining a leaflet frame inflow end and a leaflet frame outflow end with a leaflet frame lumen therethrough.

3. The prosthetic valve of claim 2 , wherein the leaflet frame wall of the leaflet frame is at least partially covered with the leaflet frame cover configured to restrict fluid from passing through the covered portion of the leaflet frame wall.

4. The prosthetic valve of claim 2 , wherein the one or more leaflets are operable to open to allow flow from the leaflet frame subcomponent inflow end and to pass through the leaflet frame subcomponent outflow end in antegrade flow conditions, and are operable to close to restrict flow from flowing from the leaflet frame subcomponent outflow end through the leaflet frame subcomponent inflow end in retrograde flow conditions.

5. The prosthetic valve of claim 2 , wherein the leaflets comprise a composite material including a porous synthetic fluoropolymer membrane defining pores and an elastomer or elastomeric material filling the pores.

6. The prosthetic valve of claim 1 , wherein the anchor frame subcomponent includes an anchor frame and an anchor frame cover, the anchor frame defines a generally tubular shape extending between the anchor frame subcomponent inflow end and the anchor frame subcomponent outflow end, an anchor frame inner surface and an anchor frame outer surface defining an anchor frame wall, the anchor frame s at least partially covered with the anchor frame cover to restrict fluid from passing through the anchor frame wall.

7. The prosthetic valve of claim 6 , wherein, when the prosthetic valve is in the deployed, nested configuration, the anchor frame defines a flared portion at the anchor frame subcomponent inflow end that flares or tapers radially outward.

8. The prosthetic valve of claim 6 , wherein the connecting sheath is contiguous with the anchor frame cover and the leaflet frame cover.

9. The prosthetic valve of claim 6 , wherein the leaflet frame subcomponent includes a leaflet frame defining a leaflet frame wall, one or more leaflets, and leaflet frame cover, the leaflet frame is generally tubular shaped defining a leaflet frame inflow end and a leaflet frame outflow end with a leaflet frame lumen therethrough and, wherein the retention element is coupled to the connecting sheath between the leaflet frame and the anchor frame such that the retention element is operable to maintain the nested configuration of the anchor frame subcomponent and the leaflet frame subcomponent.

10. The prosthetic valve of claim 1 , wherein the prosthetic valve has a smaller diameter in the delivery configuration than in the deployed, nested configuration.

11. The prosthetic valve of claim 1 , wherein, in the deployed, nested configuration, the anchor frame subcomponent has an anchor frame subcomponent inner surface having a diameter at least slightly larger than a leaflet frame subcomponent outer surface of the leaflet frame subcomponent and the leaflet frame subcomponent is nested within the anchor frame subcomponent.

12. The prosthetic valve of claim 1 , wherein the connecting sheath is a thin-walled flexible tubular member having a connecting sheath inner surface that defines a connecting sheath lumen in fluid communication with the anchor frame subcomponent lumen and the leaflet frame subcomponent lumen, and wherein the connecting sheath is operable to fold and evert when the leaflet frame subcomponent is advanced from the pre-deployed, un-nested configuration to the deployed, nested configuration so as to lie between the leaflet frame subcomponent and the anchor frame subcomponent.

13. The prosthetic valve of claim 1 , wherein the connecting sheath comprises flow enabling features in a wall of the connecting sheath, the wall extending between the connecting sheath inflow end and the connecting sheath outflow end, wherein the flow enabling features are operable to allow antegrade fluid flow through the connecting sheath wall and restrict retrograde flow through the connecting sheath wall when the leaflet frame subassembly is not in the deployed, nested configuration.

14. The prosthetic valve of claim 1 , wherein the connecting sheath comprises an inner film layer and an outer film layer, the inner film layer and the outer film layer being coupled together at least at the anchor frame subcomponent outflow end, the inner film layer defi

Assignees

• Gore & Ass

Inventors

• Burkart Dustin C
• Hartman Cody L
• Titone Ryan S

Classifications

• A61F2/2418 Primary

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

• A61F2/2412 Primary

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

• A61F2002/0081

  directly machined on the prosthetic surface, e.g. holes, grooves (A61F2/30771 takes precedence) · CPC title

• A61F2/243

  Deployment by mechanical expansion · CPC title

• A61F2/2439

  Expansion controlled by filaments · CPC title