Device for endovascular aortic repair and method of using the same

• US 10,857,011 B2
• Filed: 06/24/2020
• Issued: 12/08/2020
• Est. Priority Date: 12/06/2011
• Status: Active Grant

• Current Assignee: Aortic Innovations LLC
• Original Assignee: Aortic Innovations LLC
• Inventors: Shahriari, Ali
• Primary Examiner(s): Prone, Christopher D.
• Assistant Examiner(s): Shipmon, Tiffany P
• Application Number:
  US16/910,189
• Publication Number:
  US 20200323662A1
• Time in Patent Office: 167 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

An intraluminal vascular prosthesis assembly, having a hollow cylindrical body with a first end and a second end is provided. The assembly includes, at its first end, a first vascular prosthesis portion, and at its second end, a second vascular prosthesis portion which has only a prosthesis material. The vascular prosthesis assembly has a stent portion which is provided between the first vascular prosthesis portion and the second vascular prosthesis portion, the stent portion being free of prosthesis material to allow fluid flow there through and received within the aortic arch and spanning the brachiocephalic artery, left common carotid artery, and left subclavian artery when placed within the aortic arch of a patient.

Claims

1. A heart 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, wherein the inner frame is a cylindrically extending 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 graft covering by stitching at a proximal end of the graft covering and at a proximal end of the outer frame,

wherein the graft covering extends beyond the proximal end of the outer frame and over the proximal end thereof to cover the proximal end of the outer frame,

a sealing material positioned externally to the outer frame for providing sealing between the outer frame and a patient'"'"'s anatomical wall to treat paravalvular leaks, wherein the sealing material includes a plurality of radially extending fibers that form a circumferential surface that extends outwardly of the outer frame,

wherein the fibers cover at least two circumferentially extending rows of grids formed in the open cell configuration,

wherein the valve assembly is balloon expandable.

2. The valve assembly of claim 1, wherein the fibers are engaged with the outer frame.

3. The valve assembly of claim 1, wherein the outer frame extends distally further than the prosthetic heart valve.

4. The valve assembly of claim 1, wherein the outer frame is a singular, integral component.

5. The valve assembly of claim 1, wherein the outer frame and the graft covering are attached by stitches at a distal end of the graft covering.

6. The valve assembly of claim 1, wherein the graft covering and the fibers are distinct elements.

7. The valve assembly of claim 1, wherein the valve assembly is delivered endovascularly.

8. The valve assembly of claim 1, wherein a seal is created between the inner frame and the outer frame.

9. The valve assembly of claim 1, wherein expansion of the valve assembly presses the sealing material against an aortic annulus of the patient.

10. The valve assembly of claim 1, wherein the fibers cover the at least two circumferentially extending rows of grids formed in the open cell configuration at a proximal end of the valve assembly, but do not cover a distal portion of the open cell configuration.

11. The valve assembly of claim 1, wherein expansion of the valve assembly presses the sealing material against native valve leaflets of the patient.

12. An endovascularly deployed heart 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 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 graft covering by stitching at a proximal end of the graft covering and at a proximal end of the outer frame,

wherein the graft covering extends beyond the proximal end of the outer frame and over the proximal end thereof to cover the proximal end of the outer frame;

a sealing material positioned externally to the outer frame for providing sealing between the outer frame and a patient'"'"'s anatomical wall to treat paravalvular leaks, wherein the sealing material includes a plurality of radially extending fibers that form a circumferential surface that extends outwardly of the outer frame,

wherein the fibers cover at least two circumferentially extending rows of grids formed in the open cell configuration and the at least two circumferentially extending rows radially overlap with the prosthetic leaflets,

wherein the valve assembly is balloon expandable during endovascular deployment,

wherein expansion of the valve assembly presses the sealing material against native valve leaflets of the patient.