US-12622779-B2 - Valved conduit with expandable frame

US12622779B2US 12622779 B2US12622779 B2US 12622779B2US-12622779-B2

Abstract

Various aspects of the present disclosure are directed toward apparatuses, systems, and methods that include a valved conduit. The valved conduit may include a frame element arranged within the conduit and one or more expansion elements configured to spread apart to radially expand the frame.

Inventors

Kyle W. Colavito
Michael J. Shepard

Assignees

EDWARDS LIFESCIENCES CORPORATION

Dates

Publication Date: 20260512
Application Date: 20200506

Claims (14)

1 . A valved conduit comprising: a conduit having an interior surface and an exterior surface; a frame element arranged within the conduit and having commissure posts arranged about the frame element, the frame element having a first diameter in a first configuration and configured to support a valve structure having leaflets configured to open to permit flow and close to occlude a conduit lumen and prevent flow in response to differential fluid pressure and to expand to a second, larger diameter in a second configuration in response to a force applied to an interior portion of the frame element; and one or more expansion elements arranged between or adjacent to the commissure posts and configured to spread apart to radially expand the frame element in transitioning from the first configuration to the second configuration; wherein the frame element includes a first circular rim and a second circular rim connected by the commissure posts; and wherein the one or more expansion elements are one or more first expansion elements forming portions of the first circular rim and the valved conduit further includes one or more second expansion elements forming portions of the second circular rim.
2 . The valved conduit of claim 1 , wherein the frame element is configured to house a second valve structure therein in the second configuration.
3 . The valved conduit of claim 1 , wherein the one or more first expansion elements extend toward the second circular rim.
4 . The valved conduit of claim 3 , wherein the one or more first expansion elements each include a first linear portion, a second linear portion, and a curved portion.
5 . The valved conduit of claim 4 , wherein the first linear portion and the second linear portion extend substantially parallel with a longitudinal axis of the frame element in the first configuration and are configured to angle relative to the longitudinal axis of the frame element in the second configuration.
6 . The valved conduit of claim 5 , wherein the one or more first expansion elements are arranged between the commissure posts.
7 . The valved conduit of claim 5 , wherein the one or more first expansion elements are arranged adjacent to the commissure posts.
8 . The valved conduit of claim 5 , wherein the one or more first expansion elements are arranged between portions of the commissure posts.
9 . The valved conduit of claim 5 , wherein the one or more first expansion elements includes a plurality of first expansion elements arranged between portions of each of the commissure posts.
10 . The valved conduit of claim 1 , wherein the one or more first expansion elements and the one or more second expansion elements are configured to increase a diameter of the frame element.
11 . A valved conduit for housing a first valve structure and allowing expansion for housing a second valve structure, the valved conduit comprising: a conduit having an interior surface and an exterior surface; and a frame element arranged within the conduit including a first diameter in a first configuration and configured to support the first valve structure having leaflets configured to open to permit flow and close to occlude a conduit lumen and prevent flow in response to differential fluid pressure, the frame element having: a first circular rim, a second circular rim, commissure posts arranged about the frame element and connecting the first circular rim and the second circular rim, one or more first expansion elements arranged between or adjacent to the commissure posts along the first circular rim, and one or more second expansion elements arranged between or adjacent to the commissure posts along the second circular rim, wherein the one or more first expansion elements and the one or more second expansion elements are configured to spread apart to radially expand the frame element in transitioning between the first configuration and a second, larger diameter in a second configuration to support the second valve structure having leaflets in response to a force applied to an interior portion of the frame element.
12 . The valved conduit of claim 11 , wherein the frame element is configured to deform to maintain gaps between the leaflets of the second valve structure.
13 . The valved conduit of claim 11 , wherein the one or more first expansion elements and the one or more second expansion elements are configured to hold the frame element in the second configuration at the second diameter.
14 . The valved conduit of claim 11 , wherein the one or more first expansion elements and the one or more second expansion elements are configured to expand in a sloped manner to radially expand the frame element.

Description

CROSS-REFERENCE TO RELATED APPLICATION This application is a 35 U.S.C. 371 Application of International Application PCT/US2020/031597, filed May 6, 2020, which claims the benefit of Provisional Application No. 62/843,911, filed May 6, 2019, which are incorporated herein by reference in their entireties for all purposes. FIELD The present disclosure relates generally to prosthetic valves and more specifically to apparatuses, systems, and methods that include conduits having an expandable frame therein. BACKGROUND Bioprosthetic heart valves have been developed that attempt to mimic the function and performance of a native valve. Flexible leaflets may be mechanically coupled to a relatively rigid frame that supports the leaflets and provides dimensional stability when implanted. Although bioprosthetic heart valves can provide excellent hemodynamic and biomechanical performance in the short term, they are prone to calcification and cusp tears, among other failure modes, requiring reoperation and replacement. In certain instances, leaflets may be arranged within a conduit, such as a pulmonary valve conduit. However, various situations arise in which the requisite diametric profile of a valved conduit changes from one point in time to another. For example, in pediatric applications, a valve portion of the valved conduit with a first, smaller inner diameter (i.e., the inner flow diameter) may be appropriate, but following growth of the patient, a larger inner diameter for the prosthetic valve is desirable. The removal of an existing valve and/or implantation of another valve with a larger flow diameter may give rise to various complications and concomitant risks. SUMMARY According to one example (“Example 1”), a valved conduit includes a conduit having an interior surface and an exterior surface; and a frame element arranged within the conduit and having commissure posts arranged about the frame element, the frame element having a first diameter in a first configuration and configured to support a valve structure having leaflets configured to open to permit flow and close to occlude a conduit lumen and prevent flow in response to differential fluid pressure and to expand to a second, larger diameter in a second configuration in response to a force applied to an interior portion of the frame element; and one or more expansion elements arranged between or adjacent to the commissure posts and configured to spread apart to radially expand the frame element in transitioning between the first configuration and the second configuration. According to another example (“Example 2”), further to the valved conduit of Example 1, the frame element is configured to house a second valve structure therein in the second configuration. According to another example (“Example 3”), further to the valved conduit of any one of Examples 1-2, the frame element includes a first circular rim and a second circular rim connected by the commissure posts, and the one or more expansion elements form portions of at least one of the first circular rim and the second circular rim. According to another example (“Example 4”), further to the valved conduit of Example 3, the one or more expansion elements are arranged with one of the first circular rim and the second circular rim and extend toward another of the first circular rim and the second circular rim. According to another example (“Example 5”), further to the valved conduit of Example 4, the one or more expansion elements include a first linear portion, a second linear portion, and a curved portion. According to another example (“Example 6”), further to the valved conduit of Example 5, the first linear portion and the second linear portion extend substantially parallel with a longitudinal axis of the frame element in the first configuration and are configured to angle relative to the longitudinal axis of the frame element in the second configuration. According to another example (“Example 7”), further to the valved conduit of any one of Examples 1-6, the one or more expansion elements are arranged between the commissure posts. According to another example (“Example 8”), further to the valved conduit of any one of Examples 1-7, the one or more expansion elements are arranged adjacent to the commissure posts. According to another example (“Example 9”), further to the valved conduit of any one of Examples 1-8, the one or more expansion elements are arranged between portions of the commissure posts. According to another example (“Example 10”), further to the valved conduit of any one of Examples 1-9, the frame element includes a plurality commissure posts and the one or more expansion elements includes a plurality of expansion elements arranged between portions of each of the commissure posts. According to another example (“Example 11”), further to the valved conduit of Example 10, the valved conduit also includes a plurality of additional expansion elements arranged between the commissure posts. Ac