Granted Patent B2

US 12,727,992 · App. 18/195,808 · Granted Sep 8, 2026

Inventors: Tamir S. Levi (Zikhron Yaakov, IL); Giolnara Pinhas (Hadera, IL); Liraz Marom (Olesh, IL); Elena Sherman (Pardes Hana, IL); Noam Mizrahi (Irvine, CA); Delfin Rafael Ruiz (Sun Valley, CA); Sandip Vasant Pawar (Irvine, CA); Liron Tayeb (Peduel, IL)

Assignee: Edwards Lifesciences Corporation

A61F2/2415A61F2/0077A61F2/2409A61F2/2418A61F2210/0076A61F2230/0069A61F2250/0069

Abstract

Claims (38)

1 . A prosthetic heart valve, comprising:

an annular frame having an inflow end and an outflow end;

a leaflet structure positioned within an interior of the frame; and

an outer skirt positioned on an exterior of the frame, wherein the outer skirt comprises a hydrophilic surface treatment;

wherein the outer skirt comprises a plurality of portions comprising a plurality of filaments extending outwardly from an outer surface of the outer skirt;

wherein the outer skirt comprises a plurality of strips that lack filaments extending outwardly from the outer surface, wherein the strips that lack filaments are in an alternating arrangement with the portions comprising outwardly extending filaments; and

wherein the portions comprising outwardly extending filaments are spaced apart from each other by the plurality of strips that lack outwardly extending filaments.

2 . The prosthetic heart valve of claim 1 , wherein the outer skirt comprises a plurality of filaments, wherein at least some of the plurality of filaments are coated with a hydrophilic substance to form the hydrophilic surface treatment.

3 . The prosthetic heart valve of claim 2 , wherein the hydrophilic surface treatment is covalently bonded to fibers of the coated filaments.

4 . The prosthetic heart valve of claim 2 , wherein end portions of selected ones of the plurality of filaments extend from an edge of the outer skirt to form a fringe portion extending outwardly from an outer surface of the outer skirt.

5 . The prosthetic heart valve of claim 4 , wherein filaments of the plurality of filaments of the fringe portion comprise a plurality of fibers.

6 . The prosthetic heart valve of claim 1 , wherein the hydrophilic surface treatment comprises a polyethylene glycol (PEG) coating.

7 . The prosthetic heart valve of claim 1 , wherein the hydrophilic surface treatment is on an exterior surface of the outer skirt.

8 . The prosthetic heart valve of claim 1 , wherein the outer skirt comprises a polymeric film.

9 . The prosthetic heart valve of claim 1 , wherein the hydrophilic surface treatment comprises a lubricious coating.

10 . The prosthetic heart valve of claim 1 , wherein the prosthetic heart valve is radially expandable and compressible, and wherein, when in a radially compressed state, the prosthetic heart valve is sized and shaped to be disposed within a sheath of a delivery apparatus for transcatheter delivery of the prosthetic heart valve in the radially compressed state.

11 . The prosthetic heart valve of claim 10 , wherein the prosthetic heart valve is sized and shaped for advancement of the prosthetic heart valve from the sheath of the delivery apparatus for deployment of the prosthetic heart valve at a delivery site.

12 . A prosthetic heart valve delivery system comprising:

the prosthetic heart valve of claim 1 ; and

a delivery apparatus comprising:

a shaft; and

a sheath disposed at the end of the shaft, the sheath sized and shaped to receive therein the prosthetic heart valve in a radially compressed state.

13 . A prosthetic heart valve, comprising:

an annular frame having an inflow end and an outflow end;

a leaflet structure positioned within an interior of the frame; and

an outer skirt positioned on an exterior of the frame, wherein the outer skirt comprises a polymeric film, a hydrophilic coating, a plurality of portions comprising outwardly extending fibers that extend outwardly relative to an outer surface of the polymeric film, wherein the portions comprising outwardly extending fibers are spaced apart from each other by a plurality of strips that lack outwardly extending fibers, wherein the strips that lack outwardly extending fibers are in an alternating arrangement with the portions that comprise outwardly extending fibers.

14 . The prosthetic heart valve of claim 13 , wherein the hydrophilic coating comprises a polyethylene glycol (PEG) coating.

15 . The prosthetic heart valve of claim 13 , wherein the hydrophilic coating comprises a lubricious coating.

16 . A prosthetic heart valve delivery system comprising:

the prosthetic heart valve of claim 13 ; and

a delivery apparatus comprising:

a shaft; and

a sheath disposed at the end of the shaft, the sheath sized and shaped to receive therein the prosthetic valve in a radially compressed state.

17 . A prosthetic heart valve, comprising:

an annular frame having an inflow end and an outflow end;

a leaflet structure positioned within an interior of the frame; and

an outer skirt positioned on an exterior of the frame, wherein the outer skirt comprises a polymeric film, a plurality of outwardly extending fibers that extend outwardly relative to the exterior surface of the film, and a polyethylene glycol (PEG) coating covalently bonded on the exterior surface of the outer skirt, wherein the PEG coating forms a lubricious surface on the exterior surface of the outer skirt.

18 . The prosthetic heart valve of claim 17 , wherein the polyethylene glycol (PEG) coating is covalently bonded to the plurality of fibers.

Assignments (1)

Continuity (4)

References Cited (400)