Endovascular prosthetic device, an endovascular graft prothesis with such a device, and a method for repairing an abdominal aortic aneurysm

• US 6,325,819 B1
• Filed: 08/19/1996
• Issued: 12/04/2001
• Est. Priority Date: 08/19/1996
• Status: Expired due to Term

• Current Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated)
• Inventors: Uchida, Barry T., Pavcnik, Dusan, Keller, Frederick S.
• Primary Examiner(s): PREBILIC, PAUL B
• Application Number:
  US08/697,057
• Time in Patent Office: 1,933 Days
• Field of Search: 623/1, 623/12, 623/1.15, 623/1.16, 623/1.2, 623/1.35, 623/1.36, 623/23.7, 623/1.13, 623/1.14, 623/1.11, 606/108, 606/198, 606/191, 606/192, 606/194, 606/195
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• 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 2002/061 provided with means for allowing access to secondary lumens
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• 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

Abstract

An endovascular graft prosthesis for arrangement at an aneurysm positioned in the vicinity of a bifurcation in an arterial system having a main lumen and a first and a second branch lumen. The endovascular graft prosthesis includes a prosthetic device with at least one expandable tubular frame body for arrangement in the main lumen and a first and a second graft limb. The frame body is contractible into a first shape with a smaller diameter for introduction to a vascular site upstream of the aneurysm and is radially expandable into a second shape having a larger diameter and an inner lumen. The frame body is provided with a covering which extends across the inner lumen of the tubular frame body and has two apertures each of which has a diameter of less than half the larger diameter of the frame body. The first and second limbs have a cranial end for mounting at one of the apertures and a caudal end for arrangement in one of the branch lumens. The covering is a hindrance to blood flowing past the frame body except for blood flowing into the first and second graft limbs mounted at the two apertures.

Claims

1. An endovascular prosthetic device, comprising:

at least one expandable tubular frame body, said frame body being contractible into a first shape with a smaller diameter for introduction to a vascular site and being radially expandable into a second shape having a larger diameter and an inner lumen extending from one end to the other end of the tubular frame; and

at least one covering of bio-compatible material provided for said frame body, wherein said covering extend freely across said inner lumen of the tubular frame body from a covering periphery secured to said tubular frame and has a first and a second aperture each sized to hold graft limbs, and each of said apertures has a diameter of less than half said larger diameter of the frame body, and wherein said covering is adapted to be spread out by the expansion of said tubular frame to extend orthogonally across said inner lumen, said covering having a circular-shaped outermost periphery.

2. The endovascular prosthetic device according to claim 1, wherein said at least one covering is positioned at one end of said tubular body when said tubular body is in said expanded second shape.

3. The endovascular prosthetic device according to claim 1, wherein said at least one covering is positioned at a first and a second end of said tubular body.

4. The endovascular prosthetic device according to claim 1, wherein said tubular body comprises a flexible filament formed into a closed zig-zag configuration having an endless series of straight sections joined by bends at opposite ends of said straight sections.

5. The endovascular prosthetic device according to claim 4, wherein said at least one covering is fixed to one end of said body at said bends, and wherein said tubular body is without covering on a periphery thereof extending between the body ends.

6. An endovascular graft prosthesis for arrangement at an aneurysm positioned in the vicinity of a bifurcation in a vascular system, said vascular system having a main lumen and a first and a second branch lumen, said graft prosthesis comprising the endovascular prosthetic device according to claim 1 with the tubular frame body for arrangement in said main lumen and a first and a second graft limb, said frame body being contractible into said first shape with said smaller diameter for introduction to the vascular site upstream of the aneurysm,

wherein said first limb has a cranial end for mounting at one of said apertures and a caudal end for arrangement in said first branch lumen, and said second limb has a cranial end for mounting at an other of said apertures and a caudal end for arrangement in said second branch lumen, and

wherein said covering is a hindrance to blood flowing past said frame body except for blood flowing into said first and second graft limbs mounted at the first and the second apertures.

7. The endovascular graft prosthesis according to claim 6, wherein said covering is positioned at one end of said frame body when said frame body is in said expanded second shape.

8. The endovascular graft prosthesis according to claim 6, wherein said at least one covering is positioned at a first and a second end of said frame body.

9. The endovascular graft prosthesis according to claim 6, wherein said frame body comprises a flexible filament formed into a closed zig-zag configuration having an endless series of straight sections joined by bends at opposite ends of said straight sections.

10. The endovascular graft prosthesis according to claim 9, wherein said covering is fixed to one end of said body at said bends, and wherein said frame body is without covering on a periphery thereof extending between the body ends.

11. The endovascular graft prosthesis according to claim 6, wherein each of said first and second graft limbs at said cranial end has a mounting means for gripping the covering surrounding said aperture.

12. The endovascular graft prosthesis according to claim 11, wherein each of said first and second graft limbs is contractible into a first shape with a smaller diameter for introduction to the vascular site where said prosthetic device is placed and is expandable into a second shape with a larger diameter.

13. The endovascular graft prosthesis according to claim 12, wherein said mounting means extends radially from the cranial end of the graft limb to a diameter larger than said diameter of the aperture.

14. The endovascular graft prosthesis according to claim 13, wherein said mounting means is a collar surrounding a cranial end opening of said graft limb.

15. The endovascular graft prosthesis according to claim 12, wherein each of said first and second graft limbs prior to deployment in the vascular system is positioned contracted into said first state in an introducer catheter having an outer diameter of 16 French or less.

16. The endovascular graft prosthesis according to claim 6, wherein said endovascular prosthetic device prior to deployment in the vascular system is positioned contracted into said first state in an introducer catheter having an outer diameter of 16 French or less.

17. The endovascular graft prosthesis according to claim 6, wherein said endovascular prosthetic device prior to deployment in the vascular system is positioned contracted into said first state in an introducer catheter together with two preloaded guide wires each extending through one of said apertures in said covering.

18. The endovascular graft prosthesis according to claim 6, wherein said frame body is self-expanding from said first to said second state.

19. The endovascular graft prosthesis according to claim 6, wherein said frame body is provided with anchoring means.

24. The endovascular graft prosthesis according to claim 1, wherein said tubular frame body defines single large apertures at opposite ends of said inner lumen, when expanded.

25. The endovascular graft prosthesis according to claim 1, wherein each said at least one said covering is secured to said tubular frame at a peripheral edge of said covering and extends freely therefrom.

20. A method for repairing an abdominal aortic aneurysm in an aorta having a lumen and bifurcating into a first and a second iliac artery, comprising the steps of:

providing a first catheter with a preloaded endovascular prosthetic device comprising at least one expandable tubular frame body, said frame body being contractable into a first shape with a smaller diameter for introduction to a vascular site and being radially expandable into a second shape having a larger diameter and an inner lumen and at least one covering of bio-compatible material provided for said frame body, wherein said covering extends across said inner lumen of the tubular frame body and has a first and a second aperture, each of said apertures has a diameter of less than half said larger diameter of the frame body, and wherein said covering is adapted to be spread out by the expansion of said tubular frame, and said first catheter also with a first and a second preloaded guide wire inserted through said first and second aperture, respectively,

introducing said first catheter into said first iliac artery and advancing it to a position upstream of the aneurysm,

releasing said endovascular prosthetic device from said first catheter and expanding the device so that at least part of the periphery of the frame body is in contact with the aorta upstream of said aneurysm and so that said covering extends across said aorta lumen at said frame body,

introducing a wire with a gripping means into said second iliac artery, gripping said second guide wire and pulling a caudal end section of said second guide wire from said first iliac artery into said second iliac artery ,

advancing a second catheter with a preloaded first graft limb over said first guide wire until a cranial end of said limb has passed said first aperture,

releasing said first graft limb from said second catheter so that said cranial limb end is mounted at said first aperture and a caudal end of said first graft limb is positioned in said first iliac artery, advancing a third catheter with a preloaded second graft limb over said second guide wire until a cranial end of said limb has passed said second aperture, and

releasing said second graft limb from said third catheter so that said cranial limb end is mounted at said second aperture and a caudal end of said second graft limb is positioned in said second iliac artery.

21. The method according to claim 20, wherein said endovascular prosthetic device is released from said first catheter by use of a pusher advanced through said first catheter.

22. The method according to claim 20, wherein said endovascular prosthetic device is released from said first catheter by use of a wire having a gripping means, said wire being axially introduced and advanced to said first catheter where the gripping means is engaged with said prosthetic device and used to pull s aid prosthetic device out of said first catheter.

23. The method according to claim 20, wherein said endovascular prosthetic device has one covering attached to each end of said frame body and is preloaded in said first catheter so that each covering extends away from said frame body.