Method and apparatus for deploying non-circular stents and graftstent complexes

• US 6,039,749 A
• Filed: 04/15/1997
• Issued: 03/21/2000
• Est. Priority Date: 02/10/1994
• Status: Expired due to Term

• Current Assignee: Cardinal Health Switzerland 515 GmbH (Cardinal Health, Inc.)
• Original Assignee: Endovascular Systems, Inc.
• Inventors: Marin, Michael L., Marin, Ralph
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): LEWIS, WILLIAM W
• Application Number:
  US08/838,126
• Time in Patent Office: 1,071 Days
• Field of Search: 606/1, 606/108, 606/191, 606/194, 606/195, 606/198, 606/200, 623/1, 623/12, 604/96-101
• 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 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• 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 2220/0033 made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2230/0034 D-shaped
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

Disclosed is a non-circular stent, as well as a graftstent complex, that may be used for isolating a pathological defect in the vicinity of a branching passageway. Also disclosed is an apparatus for expanding a stent and for aligning same relative to another stent. Further, a method for excluding a pathological defect such as an aortic aneurysm is disclosed.

Claims

1. A stent having a non circular cross-section when expanded, comprising:

a tubular wall defining a curved edge and an alignment edge; and

an orientation marker positioned on said tubular wall with a predetermined rotational relationship relative to said alignment edge.

2. The stent as in claim 1, wherein said stent self-expands to the non-circular cross-section.

3. The stent as in claim 1, wherein the non-circular cross-section is a generally "D" shaped configuration.

4. The stent as in claim 1, wherein said curved edge is shaped to engage a body lumen and said alignment edge is shaped to engage another stent.

5. The stent as in claim 1, wherein said stent is attached to a segment of graft material.

6. The stent as in claim 5, wherein said stent has a proximal end and a distal end, said graft material having an end cut on a bias, said end being attached to said stent such that said graft material extends substantially between said proximal and distal ends along said alignment edge, yet only partially along said curved edge.

7. A method for endoluminally excluding an aortic aneurysm in a patient'"'"'s vascular system, comprising the steps of:

advancing through each branch of the patient'"'"'s femoral and iliac system a a respective graftstent complex, each graftstent complex comprising a first stent and a graft;

aligning said first stents relative to each other in a common region of normal aortic tissue on one side of the aneurysm; and

deploying each of said aligned first stents in the common region by applying a circumferentially non-uniform force from within each stent which expands it into a non-circular shape, said expanded stents being generally symmetric to one another,

whereby blood in a patient'"'"'s vascular system flows through said respective graftstent complexes and thereby excludes the aneurysm.

8. The method as in claim 7, wherein each stent is expanded into a non-circular shape solely by applying a force within each stent.

9. A system, comprising:

a stent;

an elongated catheter; and

means, connected to the catheter which supports said stent thereabout, for expanding said stent to a non-circular shape in the absence of a force external to said stent.

10. A system, comprising:

an elongated catheter defining an inflation lumen therein; and

an inflatable balloon affixed to said catheter, said balloon being preshaped to have a generally "D" shaped cross-section when inflated to the deployment size,

a stent positioned over said balloon;

whereby inflation of said balloon to the deployment size with the stent thereover causes the stent to expand from the delivery size to a non-circular shape.

11. The apparatus as in claim 10, further comprising:

means for rotatably supporting said elongated catheter.

12. The apparatus as in claim 11, further comprising:

means, on said elongated catheter, for indicating the relative rotational orientation of the inflatable balloon.

13. A graftstent complex for hemostatically bypassing an aneurysm in the vicinity of a branching passageway, comprising:

a first graft segment defining a first lumen;

a first stent attached to said first graft segment;

a second graft segment defining a second lumen;

a second stent attached to said second graft segment;

a plurality of barbs associated with at least a selected one of said first and second stents and extending from the surface of said selected stent to engage said graft attached to the other of said first and second stents.

14. The graftstent complex as in claim 13, wherein said engaging means is also for engaging an inner lining of a blood vessel to thereby anchor said selected stent.

15. A graftstent complex, comprising:

a stent having a non circular cross-section when expanded and including a tubular wall defining in at least the expanded state a curved edge and an alignment edge;

a segment of graft material attached to the stent;

an alignment marker positioned on said segment of graft material with a predetermined rotational relationship relative to said alignment edge of said stent.

16. The graftstent complex as in claim 15, wherein said stent self-expands to the non-circular cross-section.

17. The graftstent complex as in claim 15, wherein the non-circular cross-section is a generally "D" shaped configuration.

18. The graftstent complex as in claim 15, wherein said curved edge is shaped to engage a body lumen and said alignment edge is shaped to engage the stent of another graftstent compex.

19. The graftstent complex as in claim 15, wherein said stent has a proximal end and a distal end, said segment of graft material has a first end cut on a bias, said first end being attached to said stent such that said segment of graft material extends substantially between said proximal and distal ends along said alignment edge, yet only partially along said curved edge.