TRANSCATHETER VALVE REPAIR HAVING IMPROVED PARAVALVULAR SEAL

• US 20210161688A1
• Filed: 02/09/2021
• Published: 06/03/2021
• Est. Priority Date: 12/06/2011
• Status: Active Grant

• Current Assignee: Aortic Innovations LLC
• Original Assignee: Aortic Innovations LLC
• Inventors: Shahriari, Ali
• Granted Patent: US 11,129,735 B2
• Time in Patent Office: Days
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/856 Single tubular stent with a side portal passage
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/962 having an outer sleeve
• CPC Class Codes: A61F 2002/061 provided with means for allowing access to secondary lumens
• CPC Class Codes: A61F 2002/067 modular
• CPC Class Codes: A61F 2210/00 Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0057 stretchable
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/001 Figure-8-shaped, e.g. hourglass-shaped
• CPC Class Codes: A61F 2230/0034 : D-shaped
• CPC Class Codes: A61F 2230/0067 : conical
• CPC Class Codes: A61F 2250/0039 : differing in diameter
• CPC Class Codes: A61F 2250/0048 : differing in mechanical expandability, e.g. in mechanical, self- or balloon expandability
• CPC Class Codes: A61F 2250/0069 : Sealing means

Abstract

A transcatheter valve assembly replacement device includes a paravalvular seal that includes outwardly extending fibers that create a seal with the annulus when the valve assembly is deployed.

Claims

1-10. -10. (canceled)

11. A transcatheter valve assembly comprising:

an outer frame, wherein the outer frame is formed from a metallic material and defines an open cell configuration;

an inner frame that engages a prosthetic heart valve having prosthetic leaflets, wherein the inner frame includes a cylindrically extending inner graft covering extending at least partially radially outwardly of the prosthetic heart valve and radially inwardly of the outer frame for providing sealing to the prosthetic heart valve,

wherein the outer frame is secured to the inner graft covering by stitching at a proximal end of the outer frame;

an outer seal for preventing paravalvular leaks that extends over at least two rows of cells formed in the outer frame,

wherein the outer seal is formed of outwardly extending fibers positioned externally to the outer frame,

wherein the valve assembly has a radially compressed orientation and a radially expanded orientation,

wherein the valve assembly is configured to press some of the fibers against native leaflets of the aorta of the patient.

12. The valve assembly of claim 11, wherein the outwardly extending fibers include arcuate fibers that overlap in a circumferential direction relative to the outer frame with other arcuate fibers before deployment of the valve assembly.

13. The valve assembly of claim 11, wherein the outwardly extending fibers include spacing between adjacent fibers that forms an opening that extends through a thickness of the outer seal to the outer frame, wherein a porosity of the outer seal decreases when the outwardly extending fibers are compressed and at least partially cover the opening.

14. The valve assembly of claim 11,

wherein a height of a fiber of the outwardly extending fibers is greater than a thickness of the outer frame

15. The valve assembly of claim 11, wherein the outer frame extends distally further than the prosthetic heart valve.

16. The valve assembly of claim 11, wherein the outer frame is a singular, integral component.

17. The valve assembly of claim 11, wherein the outer frame and the inner graft covering are attached by stitches at a distal and proximal portion of the inner graft covering.

18. The valve assembly of claim 11, wherein the inner graft covering and the fibers are distinct elements.

19. The valve assembly of claim 11, wherein the valve assembly is delivered endovascularly.

20. The valve assembly of claim 11, wherein a seal is created between the inner frame and the outer frame.

21. The valve assembly of claim 11, wherein a portion of the outer frame is uncovered by the inner graft covering and the outer seal.

22. The valve assembly of claim 11, wherein a distal end of the outer frame extends distally beyond the prosthetic leaflets.

23. The valve assembly of claim 11, wherein the graft covering extends beyond a proximal end of the outer frame and over the proximal end thereof to cover the proximal end of the outer frame.

24. The valve assembly of claim 11, wherein the outwardly extending fibers extend outwardly to different positions relative to a centerline run through a longitudinal of the valve assembly.

25. The valve assembly of claim 11, wherein the graft covering, outer seal, and prosthetic leaflets are radially overlapping.