Valve with multi-part frame and associated resilient bridging features
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.
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 frame cover outflow edge of the leaflet frame subcomponent.
25. The prosthetic valve of claim 18 , wherein:
the connecting sheath is a thin-walled flexible tubular member that defines a connecting sheath lumen in fluid communication with an inner lumen of the anchor frame subcomponent and an inner lumen of the leaflet frame subcomponent when the prosthetic valve is in the delivery configuration; and
the connecting sheath is operable to fold and evert when the leaflet frame subcomponent is transitioned from the delivery configuration to the deployed configuration, such that the connecting sheath lies between the leaflet frame subcomponent and the anchor frame subcomponent.
26. The prosthetic valve of claim 18 , wherein;
the connecting sheath comprises flow enabling features in a wall of the connecting sheath, the wall extending between a connecting sheath inflow end and a connecting sheath outflow end; and
the flow enabling features are operable to allow antegrade fluid flow through the connecting sheath wall and prevent retrograde flow through the connecting sheath wall after initiation, but prior to completion of, transitioning of the prosthetic valve to the deployed configuration.
27. The prosthetic valve of claim 18 , 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 a leaflet frame subcomponent inflow end and an anchor frame subcomponent outflow end;
the inner film layer defines at least one inner film aperture therethrough adjacent the anchor frame subcomponent outflow end;
the outer film layer defines at least one outer film aperture therethrough adjacent the leaflet frame subcomponent; and
the inner film layer and the outer film layer are not coupled at least between one of the at least one inner film aperture and one of the at least one outer film aperture so as to define a flow space therebetween operable to permit antegrade blood flow and restrict retrograde flow therethrough after initiation, but prior to completion, of transitioning of the prosthetic valve to the deployed configuration.
28. The prosthetic valve of claim 18 , 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 an anchor frame subcomponent outflow end;
the inner film layer defines at least one inner film aperture therethrough adjacent the anchor frame subcomponent outflow end; and
the inner film layer and the outer film layer are not coupled at least downstream of the at least one inner film aperture so as to define a flow space therebetween operable to permit antegrade blood flow with the inner film layer separating from the outer film layer at the at least one inner film aperture and restrict retrograde flow therethrough with the inner film layer coming together and covering the at least one inner film aperture after initiation, but prior to completion, of transitioning of the prosthetic valve to the deployed configuration.
29. The prosthetic valve according to claim 1 , wherein the leaflet frame subcomponent includes a leaflet frame wall, one or more leaflets coupled to the leaflet frame wall, and a leaflet frame cover coupled to the leaflet frame wall, the leaflet frame wall being generally tubular in shape and defining a leaflet frame inflow end and a leaflet frame outflow end.
30. The prosthetic valve of claim 29 , wherein the leaflet frame wall includes one or more openings at least partially covered by the leaflet frame cover to define a covered portion of the leaflet frame wall, such that the leaflet frame cover is configured to restrict fluid from passing through the covered portion of the leaflet frame wall.
31. The prosthetic valve of claim 29 , wherein the one or more leaflets coupled to the leaflet frame wall are operable to:
open to allow flow from the leaflet frame subcomponent inflow end to pass through the leaflet frame subcomponent outflow end in antegrade flow conditions; and
close to restrict flow from flowing from the leaflet frame subcomponent outflow end through the leaflet frame subcomponent inflow end in retrograde flow conditions.
32. The prosthetic valve of claim 29 , wherein the one or more leaflets comprise a composite material including a porous synthetic fluoropolymer membrane defining pores and an elastomer or elastomeric material filling the pores.
33. The prosthetic valve according to claim 1 , wherein;
the anchor frame subcomponent further includes an anchor frame cover;
the anchor frame defines a generally tubular shape;
an anchor frame inner surface and an anchor frame outer surface define an anchor frame wall of the anchor frame; and
the anchor frame wall defines one or more apertures at least partially covered by the anchor frame cover to define a covered portion of the anchor frame wall, such that the anchor frame cover is configured to restrict fluid from passing through the anchor frame wall.
34. The prosthetic valve of claim 33 , wherein a connecting sheath is contiguous with the anchor frame cover and a leaflet frame cover.
35. The prosthetic valve according to claim 1 , wherein when the prosthetic valve is in the deployed configuration, the anchor frame defines a flared portion at the inflow end of the anchor frame that flares radially outward.
36. The prosthetic valve according to claim 1 , wherein the prosthetic valve has a smaller diameter in the delivery configuration than in the deployed configuration.
37. The prosthetic valve according to claim 1 , wherein, in the deployed configuration, the anchor frame subcomponent has an inner surface defining an inner diameter larger than a portion of the leaflet frame subcomponent that is nested within the anchor frame subcomponent.
38. A method of treating a native valve of a patient's anatomy comprising:
advancing a prosthetic valve in a delivery configuration to a treatment site within a patient's anatomy, wherein in the delivery configuration a leaflet frame subcomponent and an anchor frame subcomponent of the prosthetic valve are longitudinally offset from one another such that a leaflet frame subcomponent inflow end of the leaflet frame subcomponent is situated distal of an anchor frame subcomponent inflow end of the anchor frame subcomponent;
deploying the anchor frame subcomponent within a tissue annulus; and
nesting the leaflet frame subcomponent within the anchor frame subcomponent by changing a relative longitudinal position between the leaflet frame subcomponent and the anchor frame subcomponent such that 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,
wherein, during nesting of the leaflet frame subcomponent within the anchor frame subcomponent, an outflow annular groove cover of the prosthetic valve that extends between the pair of adjacent outflow end portions transitions from an extended configuration to a retracted configuration to cover the outflow annular groove.
39. A prosthetic valve comprising:
a leaflet frame subcomponent including a leaflet frame and having an inflow end and an outflow end;
a leaflet subcomponent operably coupled to the leaflet frame subcomponent;
an anchor frame subcomponent including an anchor frame and having an inflow end and an outflow end, the leaflet frame subcomponent being configured to be in a nested configuration at a nested position at least partially within the anchor frame subcomponent; and
one or more bridging members coupled between the leaflet frame subcomponent and the anchor frame subcomponent to bridge an outflow annular gap defined between the outflow end of the anchor frame and the outflow end of the leaflet frame in the nested configuration, the one or more bridging members being resiliently extendible and retractable in length between an extended configuration and a retracted configuration such that the leaflet frame subcomponent is translatable longitudinally relative to the anchor frame subcomponent.