Valve with multi-part frame and associated resilient bridging features

Patent metadata

Field	Value
Publication number	US-12447014-B2
Application number	US-202017603256-A
Country	US
Kind code	B2
Filing date	Apr 13, 2020
Priority date	Apr 12, 2019
Publication date	Oct 21, 2025
Grant date	Oct 21, 2025

Abstract

Concepts disclosed relate to multi-frame prosthetic valves including leaflet and anchor frame subcomponents, where the leaflet frame subcomponent does not directly couple with patient anatomy and is separated from the anchor frame subcomponent by a gap/space. An optional connecting sheath may be provided to interconnect the subcomponents and assist with prosthetic valve delivery and deployment. One or more bridging members, or annular groove covers, are provided to bridge and cover gap or space between the anchor frame subcomponent and leaflet frame subcomponent, such as at the inflow and/or outflow ends of the subcomponents. Such bridging/cover features may provide smoother flow profiles, reduce incidence of complications, facilitate perfusion during delivery, assist with device nesting during delivery, assist with relative subcomponent positioning following delivery, or provide any of a variety of additional or alternative functions and advantages.

First claim

What is claimed is:

1. A prosthetic valve comprising:
a leaflet frame subcomponent including a leaflet frame and having an inflow end and an outflow end;
an anchor frame subcomponent including an anchor frame and having an inflow end and an outflow end,
the anchor frame subcomponent being coupled to the leaflet frame subcomponent such that the prosthetic valve is configured to be transitioned from a delivery configuration in which the leaflet frame subcomponent and the anchor frame subcomponent are longitudinally offset from one another such that the inflow end of the leaflet frame subcomponent is situated distal of the outflow end of the anchor frame subcomponent to a deployed configuration in which the leaflet frame subcomponent is at least partially nested at a nested position within the anchor frame subcomponent such that the leaflet frame subcomponent and the anchor frame subcomponent define a pair of adjacent inflow end portions, a pair of adjacent outflow end portions, and an annular gap that includes an outflow annular groove between the leaflet frame subcomponent and the anchor frame subcomponent; and
an outflow annular groove cover extending between the pair of adjacent outflow end portions to cover the outflow annular groove between the leaflet frame subcomponent and the anchor frame subcomponent when the prosthetic valve is in the deployed configuration.

2. The prosthetic valve of claim 1 , wherein the annular gap includes an inflow annular groove and an inflow annular groove cover coupled between the pair of adjacent inflow end portions to cover the inflow annular groove when the prosthetic valve is in the deployed configuration.

3. The prosthetic valve of claim 1 , wherein the outflow annular groove cover is configured to be blood-permeable under physiologic conditions prior to the prosthetic valve being transitioned to the deployed configuration.

4. The prosthetic valve of claim 1 , wherein the outflow annular groove cover is configured to be less permeable to blood under physiologic conditions when the prosthetic valve is in the deployed configuration than when the prosthetic valve is not in the deployed configuration.

5. The prosthetic valve of claim 1 , wherein the annular gap includes an inflow annular groove and an inflow annular groove cover coupled between the pair of adjacent inflow end portions to cover the inflow annular groove when the prosthetic valve is in the deployed configuration.

6. The prosthetic valve of claim 5 , wherein the inflow annular groove cover is configured to be blood-permeable under physiologic conditions prior to the prosthetic valve being transitioned to the deployed configuration.

7. The prosthetic valve of claim 1 , wherein the outflow annular groove cover is configured to be blood impermeable under physiologic conditions subsequent to the prosthetic valve being transitioned to the deployed configuration.

8. The prosthetic valve of claim 1 , wherein the outflow annular groove cover is transitionable from an extended configuration when the prosthetic valve is in the delivery configuration to a retracted configuration when the prosthetic valve is transitioned to the deployed configuration.

9. The prosthetic valve of claim 8 , wherein the outflow annular groove cover is substantially wrinkle-free in the retracted configuration.

10. The prosthetic valve of claim 8 , wherein the outflow annular groove cover has an elastic bias that causes the outflow annular groove cover to resiliently recoil from the extended configuration to the retracted configuration when the prosthetic valve transitions from the delivery configuration to the deployed configuration.

11. The prosthetic valve of claim 8 , wherein the outflow annular groove cover has an annular wall that is configured to angulate relative to a longitudinal axis of the prosthetic valve upon transitioning the outflow annular groove cover from the extended configuration to the retracted configuration.

12. The prosthetic valve of claim 8 , wherein the outflow annular groove cover includes a porous elastic film that when in the extended configuration defines pores large enough to render the porous elastic film blood-permeable under physiologic conditions and when in the retracted configuration the pores are small enough to render the porous elastic film less permeable to blood under physiologic conditions.

13. The prosthetic valve of claim 1 , wherein the outflow annular groove cover includes a composite material formed of a fluoropolymer membrane that has been imbibed with an elastomeric material.

14. The prosthetic valve of claim 1 , wherein the outflow annular groove cover includes at least one of a pleated configuration, a sinuous folded configuration, or a zig-zag folded configuration when the prosthetic valve is in the deployed configuration.

15. The prosthetic valve of claim 1 , wherein the outflow annular groove cover is configured to provide a bias for translating the leaflet frame subcomponent to the nested position within the anchor frame subcomponent.

16. The prosthetic valve of claim 15 , wherein the bias is sufficient to longitudinally translate the leaflet frame subcomponent into the anchor frame subcomponent when the leaflet frame subcomponent is longitudinally unconstrained relative to the anchor frame subcomponent.

17. The prosthetic valve according to claim 1 , wherein:
at least a portion of the outflow annular groove cover is configured for tissue ingrowth; and
at least a portion of the outflow annular groove cover is configured to resist tissue ingrowth.

18. The prosthetic valve of claim 1 , further comprising a connecting sheath coupling the leaflet frame subcomponent to the anchor frame subcomponent such that upon transitioning the prosthetic valve to the deployed configuration, the connecting sheath is everted.

19. The prosthetic valve of claim 18 , wherein the annular gap is defined by the anchor frame subcomponent, the connecting sheath, and the leaflet frame subcomponent.

20. The prosthetic valve of claim 18 , further comprising an inflow annular groove cover coupled to and extending circumferentially adjacent an anchor frame subcomponent inflow end and a leaflet frame subcomponent inflow end, wherein:
the annular gap includes an inflow annular groove formed by the anchor frame subcomponent, the connecting sheath, and the leaflet frame subcomponent; and
the inflow annular groove cover is configured to cover the inflow annular groove when the prosthetic valve is in the deployed configuration.

21. The prosthetic valve of claim 20 , wherein, when the prosthetic valve is in the deployed configuration, the inflow annular groove cover and the outflow annular groove cover are configured to have lower permeability to blood than when the prosthetic valve is not in the deployed configuration.

22. The prosthetic valve of claim 20 , wherein, after initiation but prior to completion of transitioning the prosthetic valve to the deployed configuration, the inflow annular groove cover and the outflow annular groove cover are configured to be blood permeable.

23. The prosthetic valve of claim 18 , wherein the outflow annular groove is formed between the anchor frame subcomponent outflow end, the connecting sheath, a leaflet frame subcomponent outflow end.

24. The prosthetic valve of claim 23 , wherein the outflow annular groove cover is coupled to and circumferentially extending from the anchor frame subcomponent outflow end and a leaflet fra

Assignees

• Edwards Lifesciences Corp

Inventors

• Burkart Dustin C
• Hartman Cody L
• Manygoats Jr Roy
• Titone Ryan S

Classifications

• 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

• A61F2250/0069

  Sealing means · CPC title

• A61F2250/0063

  Nested prosthetic parts · CPC title

• A61F2250/0039

  differing in diameter · CPC title

• A61F2250/001

  for adjusting a diameter · CPC title