Diametric expansion features for prosthetic valves
Various features and associated advantages are described for diametrically adjustable support structures, adjustable valve structures, removable/replaceable valve structures, and associated systems and methods. Although some examples are directed toward prosthetic valve that is a conduit having a valve structure, or a “valved conduit” (e.g., used to replace a pulmonary valve and a portion of the corresponding pulmonary artery or an aortic valve and the aortic root), and other examples are directed toward prosthetic valves implanted native valve orifices (e.g., to replace an aortic or mitral valve), the features and advantages of the structures associated with those examples are interchangeable regardless of a particular application for which the examples are described.
1. A prosthetic valve comprising:
one or more primary leaflets each defining a primary leaflet base, a primary leaflet free edge, a primary leaflet first commissure region, a primary leaflet second commissure region, and a primary leaflet belly region; and
one or more auxiliary leaflets stored in an inactive state, each of the one or more auxiliary leaflets defining an auxiliary leaflet base, an auxiliary leaflet free edge, an auxiliary leaflet first commissure region, an auxiliary leaflet second commissure region, and an auxiliary leaflet belly region, the one or more auxiliary leaflets being configured to release to an active state upon diametrically expanding the prosthetic valve.
2. The prosthetic valve of claim 1 , wherein the one or more auxiliary leaflets are stored in the inactive state by one or more folds formed by the one or more primary leaflets, the one or more folds of the primary leaflets being releasably secured in a folded configuration and configured to be released from the folded configuration upon diametrically expanding the prosthetic valve to transition the auxiliary leaflets to the active state.
3. The prosthetic valve of claim 2 , wherein at least one of the primary leaflets includes a first side region, a second side region, and a central region located between the first and second side regions, and wherein the one or more folds are formed in at least one of the first side region, the second side region, and the central region.
4. The prosthetic valve of claim 2 , wherein the one or more folds formed by the one or more primary leaflets are releasably secured in the folded configuration by a coating, an adhesive, a thermal bond, a mechanical fastener, or combinations thereof.
5. The prosthetic valve of claim 2 , wherein the one or more folds formed by the one or more primary leaflets are releasably secured in the folded configuration such that the folds formed by the primary leaflets are configured to be released from the folded configuration upon an expansion force being imparted on the prosthetic valve and/or fallowing an extended period of time.
6. The prosthetic valve of claim 2 , wherein the one or more primary leaflets include a pair of adjacent primary leaflets and the one or more folds formed by the primary leaflets are positioned at a location corresponding to a commissure region between pair of adjacent primary leaflets.
7. The prosthetic valve of claim 1 , wherein the prosthetic valve includes a support structure to which the one or more primary leaflets are coupled.
8. The prosthetic valve of claim 7 , wherein the support structure includes a tubular conduit.
9. The prosthetic valve of claim 7 , wherein the support structure includes a frame.
10. The prosthetic valve of claim 7 , wherein the one or more auxiliary leaflets are stored in the inactive state by one or more folds formed by the support structure, the folds of the support structure each being releasably secured in a folded configuration and configured to be released from the folded configuration upon diametrically expanding the prosthetic valve to transition the auxiliary leaflets to the active state.
11. The prosthetic valve of claim 10 , wherein the one or more folds formed by the support structure are releasably secured in the folded configuration by a coating, an adhesive, a thermal bond, a mechanical fastener, or combinations thereof.
12. The prosthetic valve of claim 10 , wherein the one or more folds formed by the support structure are releasably secured in the folded configuration such that the folds formed by the support structure are configured to release from the folded configuration upon an expansion force being imparted on the prosthetic valve and/or following an extended period of time.
13. The prosthetic valve of claim 10 , wherein the one or more primary leaflets include a pair of adjacent primary leaflets and the one or more folds formed by the support structure are positioned at a location along the support portion corresponding to a commissure region between the pair of adjacent primary leaflets.
14. The prosthetic valve of claim 1 , wherein the primary leaflets include a pair of adjacent, primary leaflets coupled to a splittable commissure support, and further wherein one of the auxiliary leaflets is coupled to the splittable commissure support such that the auxiliary leaflet is transitionable from the stored, inactive state to the released, active state upon diametrically expanding the prosthetic valve to split the splittable commissure support.
15. The prosthetic valve of claim 14 , wherein the splittable commissure support is releasably secured together by a coating, an adhesive, a thermal bond, a mechanical fastener, or combinations thereof.
16. The prosthetic valve of claim 14 , wherein the releasable commissure support is configured to be released and split upon an expansion force being imparted on the prosthetic valve and/or following an extended period of time.
17. The prosthetic valve of claim 1 , wherein the prosthetic valve has a first operative diameter at which the prosthetic valve is configured to be implanted and a second operative diameter that is larger than the first operative diameter to which the prosthetic valve is configured to be diametrically adjusted, and further wherein the one or more of primary leaflets are operable to move between open and closed positions to allow and inhibit flow, respectively, through the prosthetic valve such that the primary leaflets are configured in an active state, and further wherein the prosthetic valve is configured such that upon transitioning to the second operative diameter the one or more auxiliary leaflets are transitioned to the active state such that the auxiliary leaflets are operable to move between open and closed positions to allow and inhibit flow, respectively, through the prosthetic valve.
18. The prosthetic valve of claim 17 , wherein the one or more primary leaflets are configured to be in the active state when the prosthetic valve is at the second operative diameter.
19. A method of making a prosthetic valve, the method comprising:
forming a valve structure including one or more primary leaflets each defining a primary leaflet base, a primary leaflet free edge, a primary leaflet first commissure region, a primary leaflet second commissure region, and a primary leaflet belly region, and one or more auxiliary leaflets each of the one or more auxiliary leaflets defining an auxiliary leaflet base, an auxiliary leaflet free edge, an auxiliary leaflet first commissure region, an auxiliary leaflet second commissure region, and an auxiliary leaflet belly region;
associating the valve structure with a support structure; and
storing the one or more auxiliary leaflets in an inactive state such that the one or more auxiliary leaflets are configured to release to an active state upon diametrically expanding the prosthetic valve.
20. A method of treatment of a body conduit of a patient susceptible to changes in diameter over time, the method comprising:
delivering a prosthetic valve to a treatment site for a body conduit, the prosthetic valve having a first operative diameter including one or more primary leaflets of the prosthetic valve being operable to move between open and closed positions to allow and inhibit flow, respectively, through the prosthetic valve such that the primary leaflets are configured in an active state when the prosthetic valve is at the first operative diameter, the first operative diameter further including one or more auxiliary leaflets of the prosthetic valve being stored in an inactive state in which the auxiliary leaflets are inoperable to inhibit flow through the valve, each of the one or more primary leaflets defining a primary leaflet base, a primary leaflet free edge, a primary leaflet first commissure region, a primary leaflet second commissure region, and a primary leaflet belly region, and each of the one or more auxiliary leaflets defining an auxiliary leaflet base, an auxiliary leaflet free edge, an auxiliary leaflet first commissure region, an auxiliary leaflet second commissure region, and an auxiliary leaflet belly region; and
securing the prosthetic valve at the treatment site.
21. The method of claim 20 , further comprising diametrically adjusting the prosthetic valve implanted in the patient to a second operative diameter including the one or more auxiliary leaflets being transitioned from the inactive state to an active state in which the one or more auxiliary leaflets are operable to move between open and closed positions to allow and inhibit flow, respectively, through the prosthetic valve.
22. A prosthetic valve, comprising:
a first leaflet component having one or more openings defining one or more relief features configured to facilitate outward widening of the first leaflet component; and
a second leaflet component at least partially overlapping the one or more relief features of the first leaflet component and defining an overlap region with the first leaflet component having a width,
the first leaflet component and the second leaflet component configured to be in operable engagement with one another when the prosthetic valve is at a first diameter at which the prosthetic valve is configured to be implanted to allow fluid flow through the prosthetic valve in a first direction and inhibit fluid flow through the prosthetic valve in an opposite, second direction, and
the first leaflet component and the second leaflet component being configured to be in operable engagement with one another when the prosthetic valve is at a second diameter that is larger than the first diameter by sliding relative to each other thereby reducing the width of the overlap region as the diameter of the prosthetic valve is increased, such that the first and second leaflet components allow fluid flow through the prosthetic valve in the first direction and inhibit fluid flow through the prosthetic valve in the opposite, second direction when the prosthetic valve is at the second, larger diameter.