Granted Patent B2

US 12,702,551 · App. 18/779,019 · Granted Aug 11, 2026

Inventors: Joshua C. Haarer (Flagstaff, AZ); Cody L. Hartman (Flagstaff, AZ); Roy Manygoats, Jr. (Flagstaff, AZ); Ryan S. Titone (Flagstaff, AZ); Eric M. Tittelbaugh (Flagstaff, AZ)

Assignee: Edwards Lifesciences Corporation

A61F2/2418A61F2/2436A61F2/246A61F2/2433A61F2/2439A61F2/2454A61F2002/825A61F2210/0014A61F2220/0016A61F2220/0025A61F2220/0075A61F2230/005A61F2230/0052A61F2230/0054A61F2230/0069A61F2250/0039A61F2250/006A61F2250/0063

Abstract

Claims (36)

1 . A prosthetic implant transitionable between a delivery configuration and a deployed configuration in-situ, the prosthetic implant comprising:

a leaflet frame comprising a proximal end and a distal end;

an anchor frame comprising a proximal end and a distal end, wherein:

when situated in the delivery configuration, the leaflet frame subcomponent and the anchor frame are longitudinally offset from one another;

when transitioned to the deployed configuration in-situ, the leaflet frame is nested within an interior region defined by the anchor frame such that an annular region is defined between the anchor frame and the leaflet frame; and

an interstage:

coupling the anchor frame distal end to the leaflet frame proximal end; and

comprising a film assembly comprising (i) an inner film layer that includes a first set of apertures and (ii) an outer film layer that includes a second set of apertures that are non-overlapping with the first set of apertures, the film assembly adapted to obstruct retrograde flow of blood through the annular region in the deployed configuration.

2 . The prosthetic implant of claim 1 , wherein the leaflet frame further comprises one or more projections configured to engage native leaflet tissue.

3 . The prosthetic implant of claim 1 , wherein the leaflet frame further comprises at least one first tissue retention feature and at least one second tissue retention feature, wherein the at least one first tissue retention feature is configured to engage a native anterior leaflet of a native mitral valve, and wherein the at least one second tissue retention feature is configured to engage a native posterior leaflet of the native mitral valve.

4 . The prosthetic implant of claim 1 , wherein the leaflet frame comprises nitinol.

5 . The prosthetic implant of claim 1 , wherein the anchor frame comprises nitinol.

6 . The prosthetic implant of claim 1 , wherein the leaflet frame subcomponent is at least partially covered by fabric.

7 . The prosthetic implant of claim 1 , wherein the anchor frame subcomponent is at least partially covered by fabric.

8 . The prosthetic implant of claim 1 , wherein the leaflet frame comprises one or more elements configured to restrict retrograde blood flow relative to the prosthetic implant.

9 . The prosthetic implant of claim 1 , further comprising fabric extending from the leaflet frame subcomponent to the anchor frame.

10 . The prosthetic implant of claim 1 , wherein the inner layer and the outer layer define a flow space therebetween operable to permit flow therethrough when the leaflet frame is not nested in the anchor frame, and is operable to restrict flow when the leaflet frame is nested within the anchor frame.

11 . The prosthetic implant of claim 10 , wherein when the leaflet frame is not nested in the anchor frame the first set of apertures and the second set of apertures are operable to restrict retrograde flow through the flow space.

12 . The prosthetic implant of claim 1 , wherein the first set of apertures are vertically aligned with the second set of apertures.

13 . The prosthetic implant of claim 1 , wherein the first set of apertures are closer to the anchor frame than the second set of apertures when the prosthetic implant is in the delivery configuration.

14 . A prosthetic implant comprising:

a first frame comprising a proximal end and a distal end; and

a second frame comprising a proximal end and a distal end, wherein:

when situated in a delivery configuration, the first frame subcomponent and the second frame are longitudinally offset from one another;

when transitioned to a deployed configuration in-situ, the first frame is nested within an interior region defined by the second frame such that an annular region is defined between the anchor first and the second frame; and

an interstage:

coupling the second frame distal end to the first frame proximal end; and

comprising a film assembly comprising (i) an inner film layer and (ii) an outer film layer, the film assembly:

defining a flow space therebetween operable to permit flow therethrough when the first frame is not nested in the second frame, and is operable to restrict flow when the first frame is nested within the second frame; and

adapted to obstruct retrograde flow of blood through the annular region in the deployed configuration.

15 . The prosthetic implant of claim 14 , wherein the first frame further comprises one or more tissue graspers.

16 . The prosthetic implant of claim 14 , wherein the first frame further comprises at least one first tissue retention feature and at least one second tissue retention feature, wherein the at least one first tissue retention feature is configured to engage a native anterior leaflet of a native mitral valve, and wherein the at least one second tissue retention feature is configured to engage a native posterior leaflet of the native mitral valve.

17 . The prosthetic implant of claim 14 , wherein the first frame and the second frame subcomponent comprise nitinol.

18 . The prosthetic implant of claim 14 , wherein the first frame and the second frame subcomponent are at least partially covered by fabric.

19 . The prosthetic implant of claim 14 , further comprising one or more elements configured to restrict retrograde blood flow relative to the prosthetic implant.

20 . The prosthetic implant of claim 19 , wherein the one or more elements are prosthetic leaflets.

Assignments (2)

Continuity (5)

References Cited (400)