TRANSCATHETER AORTIC VALVE REPAIR HAVING IMPROVED PARAVALVULAR SEAL

• US 20210106445A1
• Filed: 12/23/2020
• Published: 04/15/2021
• 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 10,987,236 B1
• 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 2250/0048 : differing in mechanical expandability, e.g. in mechanical, self- or balloon expandability
• CPC Class Codes: A61F 2250/0069 : Sealing means

Abstract

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

Claims

1-10. -10. (canceled)

11. A transcatheter aortic valve assembly comprising:

an outer frame formed from a metallic material;

an inner frame that engages a prosthetic heart valve having prosthetic leaflets, wherein the inner frame includes a cylindrically extending polymeric 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;

a first portion of fibers positioned radially outwardly of the outer frame that forms a first sealing interface against the annulus and native valve leaflets of the patient when the first portion of fibers are compressed thereagainst, wherein the first portion of fibers extend radially outwardly of the outer frame; and

a second portion of fibers carried by the outer frame that forms a second sealing interface against the outer frame when the second portion of fibers are compressed thereagainst,

wherein the transcatheter aortic valve is positioned in a patient so that the first sealing interface is in overlapping radial alignment with native valve leaflets of the aorta to seal thereagainst,

wherein the valve assembly is free of a polymeric outer graft covering that covers an exterior surface of the outer frame,

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

wherein the valve assembly is balloon expandable to the radially expanded orientation and,

wherein expansion compresses the first portion of fibers and the second portion of fibers to form the respective first sealing interface and second sealing interface.

12. The valve assembly according to claim 11, wherein the outer graft covering that the valve assembly is free of is distinct from the inner graft covering.

13. The valve assembly according to claim 11, wherein the first portion of fibers and the second portion of fibers radially overlap.

14. The valve assembly according to claim 11, wherein the inner graft covering extends to the proximal inflow end of the outer frame, wherein, stitching extending between the inner graft covering through the outer frame secures the inner graft covering to the proximal inflow end of the outer frame.