IP Library Granted Patent US 11,903,826
Granted Patent B2
US 11,903,826 · App. 17/371,915 · Granted Feb 20, 2024

Diametric expansion features for prosthetic valves

Inventors: Kyle W. Colavito (Flagstaff, AZ); Dustin V. Dienno (Flagstaff, AZ); Paul D. Goodman (Flagstaff, AZ); Brandon C. Hedberg (Flagstaff, AZ); Brandon A. Lurie (Flagstaff, AZ); Devin M. Nelson (Flagstaff, AZ)
Assignee: EDWARDS LIFESCIENCES CORPORATION
A61F2/2418A61F2/2412A61F2/2415A61F2/2475F16K15/147A61F2240/001A61F2250/001A61F2250/0071A61F2250/0082
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Quick Facts
Patent No.
US 11,903,826
App. No.
17/371,915
Granted
Feb 20, 2024
Kind
B2
Abstract

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.

Claims (37)

1. A prosthetic valve, comprising:

a first diametrically adjustable frame element configured to support a valve structure; and

a second diametrically adjustable frame element coupled to the first diametrically adjustable frame element, the second diametrically adjustable frame element including a selective expansion feature for reinforcement of the first diametrically adjustable frame element against compression at a first diameter at which the prosthetic valve is configured to be implanted and reinforcement of the first diametrically adjustable frame element against compression following diametric expansion of the first frame element to a second diameter that is larger than the first diameter;

wherein the selective expansion feature comprises an arch-shaped element including a first leg, a first base portion at a base of the first leg, a second leg, and a second base portion at a base of the second leg; and

wherein the arch-shaped element further comprises an undulating member, and wherein a first end of the undulating member is connected to an interior surface of the first leg and a second end of the undulating member is connected to an interior surface of the second leg.

2. The prosthetic valve of claim 1 , wherein the selective expansion feature is configured to self-engage upon compression at the first diameter.

3. The prosthetic valve of claim 1 , further comprising the valve structure, wherein the valve structure comprises a plurality of leaflets, and wherein each of the plurality of leaflets comprises a base portion and a coaptation edge opposing the base portion.

4. The prosthetic valve of claim 3 , wherein the plurality of leaflets comprise at least two primary leaflets and at least one auxiliary leaflet, and wherein the auxiliary leaflet is configured to, when the first frame element is diametrically expanded, transition from a stored, inactive state to an active state where the coaptation edge of the auxiliary leaflet is freed for coaptation with one or more of the coaptation edges of the two primary leaflets.

5. The prosthetic valve of claim 1 , wherein the first base portion and the second base portion are configured to come into contact to self-engage upon compression of the first frame elements at the first diameter.

6. The prosthetic valve of claim 1 , wherein the undulating member has an undulating shape at the first diameter and a more straight, less undulating shape at the second diameter.

7. The prosthetic valve of claim 1 , wherein the valve structure comprises a plurality of commissures and the first frame element comprises a plurality of split commissure posts for attachment of the commissures thereto, each of the split commissure posts comprising a first arm and a second arm joined by an end portion.

8. The prosthetic valve of claim 7 , wherein the first arm and the second arm have a first distance therebetween when the first frame element is at the first diameter and have a second distance therebetween when the first frame element is at the second diameter, the second distance greater than the first distance.

9. The prosthetic valve of claim 7 , wherein the selective expansion feature is one of a plurality of selective expansion features, and wherein each of the selective expansion features is aligned with one of the split commissure posts in a direction extending from an inflow end to an outflow end of the prosthetic valve.

10. A prosthetic valve comprising:

a valve structure comprising a plurality of leaflets;

a first diametrically adjustable frame element having the valve structure attached thereto, the first frame element comprising a plurality of split commissure posts, wherein the split commissure posts comprise a first arm and a second arm joined by an end portion and are configured to have a distance between the first arm and the second arm increased to diametrically expand the first frame element from a first diameter at which the prosthetic valve is implanted to a second larger diameter; and

a second diametrically adjustable frame element axially aligned with and coupled to the first frame element, wherein the second frame element is configured for reinforcement of the first frame element against compression at each of the first diameter and the second larger diameter;

wherein the second frame element comprises an annular body having one or more curved segments and one or more selectively expandable portions disposed between the curved segments;

wherein the one or more selectively expandable portions each comprise an arch-shaped element including a first leg, a first base portion at a base of the first leg, a second leg, and a second base portion at a base of the second leg; and

wherein the arch-shaped element further comprises an undulating member, wherein a first end of the undulating member is connected to an interior surface of the first leg and a second end of the undulating member is connected to an interior surface of the second leg, and wherein the undulating member has a more undulating shape at the first diameter and a more straight, less undulating shape at the second diameter.

11. The prosthetic valve of claim 10 , wherein the first base portion and the second base portion are configured to come into contact to self-engage upon compression of the first frame element at the first diameter.

12. The prosthetic valve of claim 10 , wherein the arch-shaped element further comprises an apex portion joining the first leg and the second leg, and wherein the apex portion has a narrower angled shape at the first diameter and a wider angled shape at the second diameter.

13. The prosthetic valve of claim 10 , wherein each of the plurality of leaflets comprises a base portion and a coaptation edge opposing the base portion; and

wherein the plurality of leaflets comprise at least two primary leaflets and at least one auxiliary leaflet, and wherein the auxiliary leaflet is configured to, when the first frame element is diametrically expanded, transition from a stored, inactive state to an active state where the coaptation edge of the auxiliary leaflet is freed for coaptation with one or more of the coaptation edges of the two primary leaflets.

14. The prosthetic valve of claim 10 , wherein the arch-shaped element is one of a plurality of arch-shaped elements, and wherein each of the arch-shaped elements is aligned with one of the split commissure posts in a direction extending from an inflow end to an outflow end of the prosthetic valve.

15. A prosthetic valve, comprising:

a valve structure comprising a plurality of leaflets;

a first diametrically adjustable frame element which is diametrically expandable to transition the prosthetic valve from a first diameter at which the prosthetic valve is implanted to a second larger diameter; and

a second diametrically adjustable frame element axially aligned with and coupled to the first frame element, wherein the second frame element is configured for reinforcement of the first frame element against compression at each of the first diameter and the second larger diameter of the prosthetic valve;

wherein the second diametrically adjustable frame element comprises one or more selectively expandable arch-shaped elements, each arch-shaped element comprising a first leg, a second leg, and an undulating member, and wherein the undulating member is connected to an interior surface of the first leg and a second end of the undulating member is connected to an interior surface of the second leg.

16. The prosthetic valve of claim 15 , wherein the first frame element comprises a plurality of expandable commissure split posts, and wherein the one or more selectively expandable arch-shaped elements comprise a plurality of arch-shaped elements each of the arch-shaped elements aligned with one of the commissure split posts in a direction extending from an inflow end to an outflow end of the prosthetic valve.

17. The prosthetic valve of claim 15 , wherein each arch-shaped element further comprises an apex portion joining the first leg and the second leg, and wherein the apex portion has a narrower angled shape at the first diameter and a wider angled shape at the second diameter.

18. The prosthetic valve of claim 15 , wherein the undulating member has a more undulating shape at the first diameter and a more straight, less undulating shape at the second diameter.

19. The prosthetic valve of claim 15 , wherein each arch-shaped element further comprises a first base portion at a base of the first leg, and a second base portion at a base of the second leg.

20. The prosthetic valve of claim 19 , wherein the first base portion and the second base portion are configured to come into contact to self-engage upon compression of the first frame element at the first diameter.

21. The prosthetic valve of claim 15 , wherein each of the plurality of leaflets comprises a base portion and a coaptation edge opposing the base portion; and

wherein the plurality of leaflets comprise at least two primary leaflets and at least one auxiliary leaflet, and wherein the auxiliary leaflet is configured to, when the first frame element is diametrically expanded, transition from a stored, inactive state to an active state where the coaptation edge of the auxiliary leaflet is freed for coaptation with one or more of the coaptation edges of the two primary leaflets.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 29, 2023
From: W. L. GORE & ASSOCIATES, INC.
To: EDWARDS LIFESCIENCES CORPORATION
Reel/Frame 064164/0030 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 15, 2023
From: COLAVITO, KYLE W; DIENNO, DUSTIN V; GOODMAN, PAUL D; HEDBERG, BRANDON C; NELSON, DEVIN M; LURIE, BRANDON A
To: W. L. GORE & ASSOCIATES, INC.
Reel/Frame 062705/0311 →
Continuity (3)
Continuation 16355515 · Mar 15, 2019
Provisional Application 62644156 · Mar 16, 2018
Related Publication 20210330457A1 · Oct 28, 2021