IP Library Granted Patent US 11,013,595
Granted Patent B2
US 11,013,595 · App. 16/100,601 · Granted May 25, 2021

Sealing element for prosthetic heart valve

Inventors: Tamir S. Levi (Zikhron Yaakov, IL); Giolnara Pinhas (Hadera, IL); Liraz Marom (Olesh, IL); Elena Sherman (Pardes Hanna, IL); Noam Mizrahi (Irvine, CA); Delfin Rafael Ruiz (Irvine, CA); Sandip Vasant Pawar (Irvine, CA); Liron Tayeb (Peduel, IL)
Assignee: Edwards Lifesciences Corporation
A61F2/2415A61F2/0077A61F2/2409A61F2/2418A61F2210/0076A61F2230/0069A61F2250/0069
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Quick Facts
Patent No.
US 11,013,595
App. No.
16/100,601
Granted
May 25, 2021
Kind
B2
Abstract

An implantable prosthetic valve that is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration includes an annular frame having an inflow end, an outflow end, and a longitudinal axis. A leaflet structure is positioned within the frame and secured thereto, and a sealing element is secured to the frame. The sealing element includes a first woven portion extending circumferentially around the frame. The first woven portion includes a plurality of interwoven filaments. The sealing element further includes a second woven portion extending circumferentially around the frame and spaced apart from the first woven portion along the longitudinal axis of the frame. At least a portion of the filaments exit the weave of the first woven portion and form loops extending radially outwardly from the frame.

Claims (37)

1. An implantable prosthetic valve that is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration, the prosthetic valve comprising:

an annular frame having an inflow end, an outflow end, and a longitudinal axis;

a leaflet structure positioned within the frame and secured thereto; and

a sealing element secured to the frame, the sealing element comprising:

a first woven portion extending circumferentially around the frame, the first woven portion comprising a plurality of interwoven filaments;

a second woven portion extending circumferentially around the frame and spaced apart from the first woven portion in a downstream direction along the longitudinal axis of the frame;

wherein at least a portion of the filaments exit a weave of the first woven portion and form loops extending radially outwardly from the frame, and extending in the downstream direction along the longitudinal axis of the frame to the second woven portion.

2. The prosthetic valve of claim 1 , wherein:

the sealing element comprises a first row of loops extending between the first woven portion and the second woven portion; and

the sealing element comprises a second row of loops spaced apart from the first row of loops in the downstream.

3. The prosthetic valve of claim 2 , wherein:

the plurality of interwoven filaments of the first woven portion further comprises at least one first filament interwoven with a plurality of second filaments; and

a portion of the at least one first filament forms the loops of the first woven portion.

4. The prosthetic valve of claim 3 , wherein the second filaments are warp yarns and the at least one first filament is a weft yarn.

5. The prosthetic valve of claim 4 , wherein at least one of the warp and weft yarns comprise textured yarns.

6. The prosthetic valve of claim 4 , wherein the warp and weft yarns comprise fibers, the fibers having a diameter of from 1 μm to 20 μm to promote thrombus formation around the sealing element.

7. The prosthetic valve of claim 1 , wherein the filaments that form the loops exit the weave of the first woven portion and are incorporated into a weave of the second woven portion such that the loops form a floating yarn portion between the first and second woven portions.

8. The prosthetic valve of claim 7 , wherein the floating yarn portion comprises a first layer of loops and a second layer of loops radially outward of the first layer of loops.

9. The prosthetic valve of claim 8 , wherein:

the sealing element comprises a first fabric strip, a second fabric strip, and a third fabric strip;

a plurality of the filaments that form the loops extend between the first fabric strip and the second fabric strip;

a plurality of the filaments that form the loops extend between the second fabric strip and the third fabric strip; and

the sealing element is folded about the second fabric strip such that the first fabric strip and the third fabric strip are adjacent each other to form the first woven portion, the filaments extending between the first fabric strip and the second fabric strip form the first layer of loops, and the filaments extending between the second fabric strip and the third fabric strip form the second layer of loops.

10. The prosthetic valve of claim 1 , wherein the sealing element is secured to the frame such that the filaments that exit the weave of the first woven portion form the loops when the frame is in the expanded configuration, and are pulled straight when the frame is in the collapsed configuration.

11. A method, comprising:

mounting the prosthetic valve of claim 1 to a distal end portion of a delivery apparatus;

advancing the delivery apparatus through a patient's vasculature to the heart; and

expanding the prosthetic valve in a native heart valve of the heart such that the prosthetic valve regulates blood flow through the native heart valve.

12. The prosthetic valve of claim 1 , wherein the filaments forming the loops are oriented along the longitudinal axis of the frame.

13. The prosthetic valve of claim 1 , wherein the loops form curves open toward the frame.

14. The prosthetic valve of claim 13 , wherein a curvature of the loops is defined at least in part by a distance between the first woven portion and the second woven portion along the longitudinal axis of the frame.

15. The prosthetic valve of claim 1 , wherein the loops form a non-woven portion of the sealing element located between the first woven portion and the second woven portion.

16. The prosthetic valve claim 7 , wherein the floating yarn portion is configured to provide compressible volume when the frame is in the expanded configuration.

17. The prosthetic valve claim 16 , wherein a thickness of the floating yarn portion is configured to decrease as the frame moves between the expanded configuration and the collapsed configuration.

18. The prosthetic valve of claim 7 , wherein the floating yarn portion is one of a plurality of discrete floating yarn portions spaced apart from each other along the longitudinal axis of the frame.

19. The prosthetic valve of claim 1 , wherein at least one of the first woven portion and the second woven portion comprises a leno weave pattern.

20. The prosthetic valve of claim 1 , wherein the sealing element further comprises a third woven portion comprising a leno weave pattern and a plain weave pattern.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 15, 2018
From: LEVI, TAMIR S.; PINHAS, GIOLNARA; MAROM, LIRAZ; SHERMAN, ELENA; MIZRAHI, NOAM; RUIZ, DELFIN RAFAEL; PAWAR, SANDIP VASANT; TAYEB, LIRON
To: EDWARDS LIFESCIENCES CORPORATION
Reel/Frame 047165/0456 →
Continuity (2)
Provisional Application 62544704 · Aug 11, 2017
Related Publication 20190046314A1 · Feb 14, 2019
Cited By (5)
US 12,364,598 US 12,551,336 US 12,575,927 US 12,616,569 US 12,727,992