DEVICE FOR ENDOVASCULAR AORTIC REPAIR AND METHOD OF USING THE SAME

• US 20130144373A1
• Filed: 12/06/2012
• Published: 06/06/2013
• 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 8,940,040 B2
• Time in Patent Office: Days
• US Class Current: 623/1.12
• 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 device and method for endovascular repair of a patient'"'"'s aorta is disclosed. The device includes a frame component that has a balloon-expandable frame and a self-expanding frame secured to the balloon-expandable frame. The device also includes a valve element positioned at the proximal end of the frame component. The device may include another prosthetic component that may be secured to the frame component. The prosthetic component may include at least one conduit configured to receive a covered stent.

Claims

1. An endograft device for endovascular repair of ascending aortic aneurysms, comprising:

a first prosthetic component comprising (i) a proximal frame, and (ii) a distal frame secured to the proximal frame and extending to a distal end of the first prosthetic component,

at least one conduit secured to the first prosthetic component and positioned adjacent to the proximal frame,

a second prosthetic component secured to a proximal end of the first prosthetic component, the second prosthetic component comprising (i) a balloon-expandable frame extending distally from a proximal end of the second prosthetic component, and (ii) a self-expanding frame connected to the balloon-expandable frame and extending to a distal end of the second prosthetic component, and

a valve element secured to the balloon-expandable frame at the proximal end of the second prosthetic component.

2. The endograft device of claim 1, wherein the self-expanding frame has an hourglass shape.

3. The endograft device of claim 2, wherein the self-expanding frame includes:

a first section that tapers inwardly between a proximal end and a distal end, and

a second section having a proximal end that is connected to the distal end of the first section, the second section tapering outwardly between the proximal end of the second section and a distal end of the second section.

4. The endograft device of claim 3, wherein the proximal end of the first section is secured to a distal end of the balloon-expandable frame.

5. The endograft device of claim 3, wherein:

the self-expanding frame includes a third section extending proximally from the proximal end of the first section, the third section having a passageway defined therein, and

the balloon-expandable frame is positioned in the passageway of the third section of the self-expanding frame.

6. The endograft device of claim 5, wherein the balloon-expandable frame is expandable between (i) an unexpanded position in which an outer surface of the balloon-expandable frame is spaced apart from an inner surface of the self-expanding frame and (ii) an expanded position in which the outer surface of the balloon-expandable frame is engaged with the inner surface of the self-expanding frame.

7. The endograft device of claim 6, wherein a plurality of fibers are attached to the third section of the self-expanding frame, and when the balloon-expandable frame is in the expanded position, the outer surface of the balloon-expandable frame is engaged with the plurality of fibers.

8. The endograft device of claim 1, wherein the proximal frame of the first prosthetic component has a passageway defined therein, and the distal end of the second prosthetic component is positioned in the passageway of the first prosthetic component.

9. The endograft device of claim 1, wherein the at least one conduit includes a pair of conduits positioned on opposite sides of the first prosthetic component.

10. The endograft device of claim 1, wherein the at least one conduit has a proximal opening that is positioned adjacent to a proximal end of the first prosthetic component.

11. The endograft device of claim 10, wherein the proximal frame includes (i) a first section secured to the distal end of the second prosthetic component, and (ii) a second section connected to the first section, the second section tapering outward between a proximal end connected to the first section and a distal end, and the at least one conduit has a distal opening defined in the second section of the proximal frame.

12. The endograft device of claim 11, further comprising a stent having a distal end positioned in the proximal opening of the at least one conduit and a proximal end configured to be positioned in a coronary artery.

13. The endograft device of claim 1, wherein:

an outer surface of the second prosthetic component and an outer surface of the proximal frame of the first prosthetic component are covered such that fluid is prevented from passing therethrough, and

an outer surface of the distal frame of the first prosthetic component is uncovered such that fluid is permitted to pass therethrough.

14. A transcatheter valve, comprising:

a frame component comprising;

a balloon-expandable frame extending distally from a proximal end of the frame component, and

a self-expanding frame secured to the balloon-expandable frame, the self-expanding frame including (i) a first section that tapers inwardly between a proximal end and a distal end, and (ii) a second section that tapers outwardly between a proximal end secured to the distal end of the first section and a distal end, and

a valve element positioned in the balloon-expandable frame at the proximal end of the frame component.

15. The transcatheter valve of claim 14, wherein:

the frame component is a dual-frame component,

the self-expanding frame is an outer frame of the dual-frame component and has a passageway defined therein,

the balloon-expandable frame is an inner frame of the dual-frame component and is positioned in the passageway defined in the self-expanding frame, and

the balloon-expandable frame is expandable between (i) an unexpanded position in which an outer surface of the balloon-expandable frame is spaced apart from an inner surface of the self-expanding frame and (ii) an expanded position in which the outer surface of the balloon-expandable frame is engaged with the inner surface of the self-expanding frame.

16. The transcatheter valve of claim 15, wherein a plurality of fibers are attached to the self-expanding frame, and when the balloon-expandable frame is in the expanded position, the outer surface of the balloon-expandable frame is engaged with the plurality of fibers.

17. The transcatheter valve of claim 14, wherein an outer surface of the first section of the self-expanding frame is uncovered such that fluid is permitted to pass therethrough and an outer surface of the second section of the self-expanding frame is covered such that fluid is prevented from passing therethrough.

18. The transcatheter valve of claim 14, wherein the self-expanding frame includes an elongated section extending distally from the second section, the elongated section having a length that is greater than a combined length of the first section and the second section.

19. The transcatheter valve of claim 14, wherein the self-expanding frame is covered with at least one of a collagen or hydrogel.

20. The transcatheter valve of claim 14, wherein the valve element is one of a bicuspid valve and a tricuspid valve.

21. A method of repairing a patient'"'"'s aorta, comprising:

introducing a first prosthetic component into the patient'"'"'s aorta such that a proximal frame of the first prosthetic component is positioned in the ascending aorta and a distal frame of the first prosthetic component is positioned in the aortic arch of the patient'"'"'s aorta,

advancing a covered stent through a conduit defined in the first prosthetic component into a coronary artery of the patient'"'"'s aorta,

securing a second prosthetic component to a proximal end of the first prosthetic component in the patient'"'"'s aorta, and

expanding a proximal section of the second prosthetic component into engagement with the aortic annulus of the patient'"'"'s aorta such that a valve element secured to the proximal section is positioned in the aortic annulus proximal to the coronary arteries.

22. The method of claim 21, wherein expanding the proximal section of the second prosthetic component includes operating a balloon-expandable frame.

23. The method of claim 22, wherein expanding the proximal section of the second prosthetic component includes:

permitting a self-expanding frame to expand into engagement with the aortic annulus, and

operating the balloon-expandable frame includes advancing an outer surface of the balloon-expandable frame into engagement with an inner surface of the self-expanding frame after the self-expanding frame is engaged with the aortic annulus.

24. The method of claim 22, wherein operating the balloon-expandable frame includes advancing an outer surface of the balloon-expandable frame into engagement with the aortic annulus.

25. The method of claim 21, wherein:

an outer surface of the second prosthetic component and an outer surface of the proximal frame of the first prosthetic component are covered such that fluid is prevented from passing therethrough, and

an outer surface of the distal frame of the first prosthetic component is uncovered such that is permitted to pass therethrough.

26. The method of claim 21, wherein:

introducing the first prosthetic component into the patient'"'"'s aorta and advancing the covered stent through the conduit defined in the first prosthetic component into the coronary artery of the patient'"'"'s aorta are performed during a first surgical procedure, and

securing the second prosthetic component to the proximal end of the first prosthetic component and expanding the proximal section of the second prosthetic component into engagement with the aortic annulus of the patient'"'"'s aorta are performed during a second surgical procedure different from the first surgical procedure.

27. The method of claim 21, further comprising introducing the second prosthetic component into the ascending aorta prior to introducing the first prosthetic component.