Device for endovascular aortic repair and method of using the same

• US 9,339,399 B2
• Filed: 12/12/2014
• Issued: 05/17/2016
• 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): Sweet, Thomas J
• Assistant Examiner(s): SHIPMON, TIFFANY P
• Application Number:
  US14/569,306
• Publication Number:
  US 20150100114A1
• Time in Patent Office: 522 Days
• US Class Current: 1/1
• 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 a stent frame,

a second prosthetic component secured to a proximal end of the first prosthetic component and comprising an expandable frame extending distally from a proximal end of the second prosthetic component, and

a valve element secured to the second prosthetic component,

wherein a selected one of the first prosthetic component and the second prosthetic component is placed into engagement with a first portion of a patient'"'"'s aorta and the other of the selected prosthetic component is then secured to the selected prosthetic component at a second portion of the patient'"'"'s aorta spaced-apart from the first portion to thereby define a total length of the combined first and second prosthetic components.

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

3. The endograft device of claim 2, wherein the expandable 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 expandable frame.

5. The endograft device of claim 1, wherein a plurality of fibers are attached to the expandable frame.

6. The endograft device of claim 5, wherein at least a portion of the frame at which the plurality of fibers are attached is otherwise uncovered.

7. The endograft device of claim 1, wherein a proximal portion of the 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 when the selected component is the first prosthetic component.

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

9. The endograft device of claim 1, wherein at least one conduit is secured to the first prosthetic component.

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

11. The endograft device of claim 9, wherein the at least one conduit has a proximal opening that is positioned adjacent to a proximal end of the first prosthetic component.

12. The endograft device of claim 1, wherein:

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

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

13. The endograft device of claim 12, wherein the outer surface that is uncovered spans the brachiocephalic artery, the left common carotid artery, and left subclavian artery.

14. The endograft device of claim 1, wherein an outer surface of the frame of the second prosthetic component that is distal to the valve is uncovered such that fluid is permitted to pass therethrough.

15. The endograft device of claim 1, wherein the first prosthetic component and the second prosthetic component are distinct items.

16. The endograft device of claim 1, wherein a position at which the first prosthetic component and the second prosthetic component are engaged is placed at a positioned defined within an aneurism of a patient.

17. The endograft device of claim 1, wherein a portion of the first prosthetic component extends into a position defined within an aneurism of a patient, and further wherein the portion tapers to a smaller diameter towards the aneurism.

18. The endograft device of claim 1, wherein the first component is expandable.

19. The endograft device of claim 1, wherein the second component is expandable.

20. The endograft device of claim 1, wherein the first component and the second component are expandable.

21. The endograft device of claim 1, wherein the first prosthetic component and the second prosthetic component are engaged with an interference fit.

22. The endograft device of claim 1, wherein a portion of the second prosthetic component is uncovered to allow fluid flow therethrough.

23. The endograft device of claim 1, wherein, a distal end of the second prosthetic component is inserted into the first prosthetic component.

24. The endograft device of claim 1, wherein a proximal end of the second prosthetic component is engaged with an aortic annulus of a patient.

25. The endograft device of claim 1, wherein the first component is released into position by removing a sheath.

26. The endograft device of claim 1, wherein the expandable frame of the second prosthetic component is balloon-expandable.

27. A method of using an endograft device for endovascular repair of ascending aortic aneurysms, comprising:

positioning a first prosthetic component having a stent frame into engagement with a first portion of a patient'"'"'s aorta,

securing a second prosthetic component to a proximal end of the first prosthetic component and into engagement with a second portion of the patient'"'"'s aorta, the second prosthetic component comprising an expandable frame extending distally from a proximal end of the second prosthetic component and having a valve element secured thereto,

wherein engagement of the first prosthetic component and the second prosthetic component defines a total length of the combined first and second prosthetic components.

28. The method of claim 27, wherein the first and second prosthetic components are telescopically engaged to define the total length of the combined first and second prosthetic components.