Biluminal endovascular graft system

• US 6,129,756 A
• Filed: 03/16/1998
• Issued: 10/10/2000
• Est. Priority Date: 03/16/1998
• Status: Expired due to Term

• Current Assignee: Cardinal Health Switzerland 515 GmbH (Cardinal Health, Inc.)
• Original Assignee: TERAMed, Inc. (Cardinal Health, Inc.)
• Inventors: Olson, Matthew J., Kugler, Chad J., Ressemann, Thomas V., Keith, Peter T., Drontle, John R., Heiland, Thomas K.
• Primary Examiner(s): Milano, Michael J.
• Application Number:
  US09/039,776
• Time in Patent Office: 939 Days
• Field of Search: 623/1, 623/12, 623/1.27, 623/1.28, 623/1.35
• US Class Current: 623/1.27
• 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 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2002/067 modular
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/826 more than one stent being applied sequentially
• 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 2220/0033 made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• 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 2230/0034 D-shaped
• CPC Class Codes: A61F 2250/0007 for adjusting length

Abstract

An endovascular graft system used to repair aneurysms in arteries which bifurcate such as the aorta which bifurcates at the aortoiliac junction. The graft system includes two legs, each defining a lumen. Each leg comprises an aortic stent, a graft component and an iliac stent. The graft component is affixed at one end to the aortic stent and at the other end to the iliac stent. Each leg of the graft system is preferably a mirror image of the other with the exception of the aortic stents. The graft component of each leg includes a means for allowing in situ adjustment of the length of the leg to accommodate the different sizes required for different patients.

Claims

1. A method for repairing an abdominal aneurysm in an aorta which branches into two iliac arteries with a graft system having first and second ends and a bellows region, the second end having an iliac stent attached thereto, the length between the first and second ends being adjustable, the method comprising:

advancing the graft system through at least one iliac artery;

positioning the first end of the graft system in the aorta on one side of the aneurysm, the second end of the graft system extending across the aneurysm;

deploying the first end of the graft system in the aneurysm in a manner that does not substantially occlude the aorta;

adjusting the length of the graft system by positioning the second end a desired distance from the first end by expanding or contracting the bellows region, and

deploying the iliac stent in an iliac artery.

2. The method of claim 1 wherein the graft system includes at least one gripping stent, the method further comprising deploying at least one gripping stent in the bellows region.

3. A method for repairing an abdominal aneurysm in an aorta which branches into two iliac arteries with a graft system having first and second legs, each leg having a graft component, an iliac stent, and an aortic stent, the iliac and aortic stents being attached to the graft component, each leg further having a first end and a second end, wherein the length between the first and second ends of at least one of the legs is adjustable, the method comprising:

advancing each of the legs through a separate iliac artery;

aligning the aortic stents relative to one another in the aorta on one side of the aneurysm, the graft component of each leg extending into a respective iliac artery across the aneurysm;

deploying the aligned aortic stents in the aorta in a manner that does not substantially occlude the aorta;

adjusting the length of at least one of the first and second legs by positioning the second end of the leg a desired distance from the first end; and

deploying the iliac stents in a respective iliac artery.

4. The method of claim 3 wherein at least one of the first and second legs is provided with a bellows region, the step of adjusting the length of at least one of the first and second legs including expanding or contracting the bellows portion of the leg to thereby adjust the length.

5. The method of claim 3 wherein at least one of the first and second legs includes a first segment and a second segment, the second segment being sized to fit within the first segment in a telescoping arrangement, the step of adjusting further comprising adjusting the relative position of the first and second segments such that the first end of the leg is a desired distance from the second.

6. The method of claim 4 wherein at least one of the first and second legs includes at least one gripping stent, the method further comprising deploying at least one gripping stent in the bellows region.

7. The method of claim 5 wherein at least one of the first and second legs includes at least one support stent, the method further including deploying at least one support stent within the second segment of the leg to maintain the relative position of the first and second segments after deployment.

8. A method for repair of an abdominal aortic aneurysm with a graft system having a graft component defining at least one lumen adapted to extend from the aorta into at least one iliac artery, the graft component having first and second ends, the method comprising:

providing a single delivery catheter having a first lumen for containing the graft system and a second contrast fluid lumen adapted to deliver contrast fluid through an exit port in the catheter;

advancing the delivery catheter to a desired location in the aorta;

manipulating the delivery catheter to secure the first end of the graft component on one side of the aneurysm;

infusing contrast fluid through the exit port of the catheter to locate the internal iliac artery which branches from the at least one iliac artery; and

manipulating the delivery catheter to secure the second end of the graft component in the at least one iliac artery between the branch of the internal iliac artery and the aneurysm.

9. The method of claim 8 wherein the graft component includes first and second graft segments, wherein the delivery catheter provided in the providing step includes an outer sheath and an inner portion contained within a lumen formed by the outer sheath, the first and second graft segments being contained within the lumen between the outer sheath and the inner portion, wherein the step of manipulating the delivery catheter to secure the first end of the graft component includes withdrawing the sheath to deploy the first graft segment, and wherein the step of manipulating the delivery catheter to secure the second end of the graft component includes withdrawing the sheath to deploy the second graft segment.

10. The method of claim 9 wherein the step of manipulating the delivery catheter to adjust the length of the graft component comprises:

advancing the delivery catheter such that a first end of the second graft segment is inserted in the first graft segment; and

withdrawing the sheath to deploy the second graft segment such that the first end of the second graft segment is deployed partially within the first graft segment and a second end of the second graft segment is secured within the at least one iliac artery.

11. A method for repair of an aneurysm in a vessel with a graft system having a graft component including first and second graft segments, the method comprising:

providing a delivery catheter having an outer sheath and an inner portion contained within a lumen formed by the outer sheath, the delivery catheter having the first and second graft segments between the inner portion and the sheath, the first and second graft segments being formed of a material which expands from a radially contracted position to a radially expanded position when the sheath is withdrawn;

the first and second graft segments being positioned in the delivery catheter in a non-overlapping manner;

providing a transition element fixed to the inner portion of the delivery catheter substantially between the first and second graft segments, the transition element having a smooth tapering diameter in the direction of the first graft segment;

advancing the delivery catheter to a desired location in the vessel on a first side of the aneurysm;

withdrawing the sheath to deploy the first graft segment in the vessel such that a first end of the first graft segment is secured on the first side of the aneurysm;

advancing the delivery catheter such that the transition element and a first end of the second graft segment are inserted in the first graft segment;

withdrawing the sheath to deploy the second graft segment such that the first end of the second graft segment is deployed partially within the first graft segment and a second end of the second graft segment is secured on a second side of the aneurysm.

12. The method of claim 11 wherein the step of providing a delivery catheter further comprises providing a delivery catheter wherein the second graft segment is positioned proximal of the first graft segment with respect to the delivery catheter and wherein the step of providing a transition element further comprises providing a transition element having a first region adjacent the first graft segment and a second region positioned further from the first graft segment than the first region, the first region having a first diameter and the second region having a second diameter, the second diameter being greater than the first diameter, the transition element having a smooth tapering diameter from the second region to the first region.

13. The method of claim 11 wherein the step of providing a transition element further comprises providing a transition element having a first end with a first diameter, a second end with a second diameter and a middle portion with a third diameter, the third diameter being greater then the first and second diameters, the transition element having a smooth tapering diameter from the middle portion to both the first and second ends.

14. The method of claim 13 wherein the step of providing a transition element farther comprises providing a substantially ball shaped transition element.

15. A method for repairing an abdominal aneurysm in an aorta which branches into two iliac arteries with a graft system having first and second legs, each leg having a graft component with first and second ends and an iliac stent attached to each of the second ends, the length between first and second ends of at least one of the legs being adjustable, the first leg having a first aortic stent, the second leg having a second aortic stent, the stents capable of expansion from a first delivery position to a second deployed position, the method comprising:

advancing the first leg through the aorta to a desired location on one side of the aneurysm;

deploying the first aortic stent so that it expands to its second deployed position, the first aortic stent causing the first end of the graft component to maintain a position on a first side of the aorta, the graft component of the first leg extending into a first iliac artery;

advancing the second leg through the aorta to a desired location adjacent the first leg, the graft component of the second leg extending into a second iliac artery;

deploying the second aortic stent so that it expands to its second deployed position causing the first end of the second graft component to be positioned adjacent the first end of the first graft component on a second side of the aorta;

adjusting the length of at least one of the first and second legs by positioning the second end of the graft component a desired distance from the first end of the graft component; and

deploying the iliac stents in a respective iliac artery.

16. The method of claim 15 wherein at least one of the first and second legs is provided with a bellows region and wherein, the step of adjusting the length of at least one of the first and second legs includes expanding or contracting the bellows portion of the leg to thereby adjust the length.

17. The method of claim 15 wherein at least one of the first and second legs includes a first segment and a second segment, the second segment being sized to fit within the first segment in a telescoping arrangement, and wherein the step of adjusting further comprises adjusting the relative position of the first and second segments such that the first end of the leg is a desired distance from the second.

18. The method of claim 16 wherein at least one of the first and second legs includes at least one gripping stent, the method further comprising deploying at least one gripping stent in the bellows region.

19. The method of claim 17 wherein at least one of the first and second legs includes at least one support stent, the method further including deploying at least one support stent within the second segment of the leg to maintain the relative position of the first and second segments after deployment.

20. A method for placement of a biluminal endovascular graft system having two legs in a vessel of a patient'"'"'s vascular system, the vessel having a main lumen and two branches, at least one of the legs being adjustable in length, each leg having first and second attachment elements and a graft component with first and second ends, the method comprising:

providing a single delivery catheter which contains a first leg of the graft system, the leg having a bellows region;

advancing the delivery catheter to a desired location in the main lumen the vessel;

manipulating the delivery catheter to secure the first end of the graft component to the main lumen of the vessel with the first attachment element;

manipulating the delivery catheter to adjust the length of the first leg by positioning the second end of the graft a desired distance from the first end by expanding or contracting the bellows region of the leg; and

securing the second end of the graft in one of the branches of the vessel with the second attachment element.

21. The method of claim 20 wherein the first leg includes at least one gripping stent, the method further comprising deploying at least one gripping stent in the bellows region.

22. A method for repair of an abdominal aortic aneurysm with a graft system having a graft component defining at least one lumen adapted to extend from the aorta into at least one iliac artery, the graft component having first and second ends and being provided with a bellows region, the method comprising:

providing a single delivery catheter which contains the graft system, the delivery catheter having a sheath;

advancing the delivery catheter to a desired location in the aorta;

manipulating the delivery catheter by withdrawing the sheath to secure the first end of the graft component on one side of the aneurysm;

manipulating the delivery catheter to adjust the length of the graft component by positioning the second end of the graft component on the other side of the aneurysm a desired distance from the first end by expanding or contracting the bellows region of the graft component to thereby adjust the length; and

further withdrawing the sheath to secure the second end of the graft component in the at least one iliac artery.