Self-expandable helical intravascular stent and stent-graft

• US 6,165,210 A
• Filed: 04/01/1994
• Issued: 12/26/2000
• Est. Priority Date: 04/01/1994
• Status: Expired due to Term

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: Gore Enterprise Holdings Incorporated (W.L. Gore and Associates)
• Inventors: McCullough, Kimberly A., Maroney, Charles Thomas, Rhee, Woonza, Lau, Lilip, Hartigan, William M.
• Primary Examiner(s): Milano, Michael J.
• Application Number:
  US08/221,815
• Time in Patent Office: 2,461 Days
• Field of Search: 623/1, 623/11, 623/12, 623/1.12, 623/1.23, 606/108, 606/191, 606/194, 606/195, 606/198
• US Class Current: 623/1.12
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• 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 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/92 Stents in the form of a rolled-up sheet expanding after insertion into the vessel , e.g. with a spiral shape in cross-section
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2002/3008 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2002/30462 retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2210/0019 operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation
• 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 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

This invention is a medical device and a method of using it. The device is a foldable stent or stent-graft which may be percutaneously delivered with (or on) an endovascular catheter or via surgical techniques or using other suitable techniques. The expandable stent structure utilizes at least one torsional member having an undulating shape which is helically deployed to form the generally cylindrical shape used as the stent. The helical winding desirably is aligned to allow those undulating shapes in adjacent turns of the helix to be in phase. The adjacent undulating shapes may be held in phased relationship using a flexible linkage, often made of a polymeric material. The stent may be flared on at least one of its ends to promote smooth blood flow at that flare and to assure that the stent will remain in the chosen position within the body. The stent'"'"'s configuration allows it to be folded or collapsed to a very small diameter prior to deployment without changing the length of the stent. The stent may be expanded with the use of an installation device such as a balloon but preferably is used as a self-expandable device.

Claims

1. A method for introducing a stent to a desired site in a body lumen comprising the steps of:

providing a generally tubular stent which is self-expandable from a collapsed state toward an uncollapsed state and which includes a member arranged in a helical configuration with multiple helical turns coupled with a flexible link and having multiple undulations, each having an unconfined apex;

introducing said self-expanding stent to a selected site in a body lumen with said stent in said collapsed state; and

releasing the collapsed self-expanding stent at the selected site so as to allow the collapsed stent to expand toward said uncollapsed state with undulations in adjacent turns being maintained generally in phase with one another with said flexible link and allowing said flexible link to move between any location within a substantial portion of a respective undulation and its corresponding apex in an unconfined manner.

2. The method of claim 1 wherein the stent is delivered to a vascular site.

3. The method of claim 1 in which the introducing step includes introducing the self-expanding stent to the site with the stent in a folded state.

4. The method of claim 3 in which the self-expanding stent is held in said folded state prior to release by an exterior sliding sheath.

5. The method of claim 3 in which the stent is held in said folded state prior to release by a slip line coupled to said stent.

6. The method of claim 1 in which the stent is metallic.

7. The method of claim 1 in which the stent is a super-elastic alloy.

8. The method of claim 1 in which the stent is nitinol.

9. The method of claim 1 in which at least one end of the stent is flared.

10. The method of claim 8 in which at least one end of the stent is flared.

11. The method of claim 1 wherein the introducing step includes introducing a stent-graft having unconfined apexes in said collapsed and expanded states.

12. The method of claim 1 wherein the introducing step includes introducing said stent with a frangible graft coupled thereto, both in a collapsed state, and the releasing step includes releasing the stent and graft to asume expanded states without fracturing the frangible graft member.

13. The method of claim 12 wherein said stent and graft member are generally coaxial.

14. The method of claim 1 wherein apexes in one turn are allowed to move into undulations in an adjacent turn in an unrestricted manner.

15. The method of claim 1 wherein said introducing step includes introducing said stent with a graft coupled thereto, and the releasing step includes releasing the collapsed self-expanding stent without changing the length of said stent.

16. The method of claim 15 wherein said stent and graft are generally coaxial after said releasing step.

17. A method for delivering a prosthetic device in a mammal comprising the steps of:

providing a generally tubular stent which is self-expandable from a collapsed state toward an uncollapsed state and which includes a member which is arranged in a helical configuration with multiple helical turns coupled with a flexible link and which has multiple undulations, each having an unconfined apex;

delivering said stent to a selected site in a body lumen with the stent in said collapsed state; and

bending the stent along its longitudinal axis as it is being delivered to the selected site, while maintaining undulations in adjacent turns generally in-phase with one another with said flexible link and allowing said flexible link to move between any location within a substantial portion of a respective undulation and its corresponding apex in an unconfined manner.

18. A method for delivering a prosthetic device in a mammal comprising the steps of:

providing a generally tubular stent which is self-expandable from a collapsed state toward an uncollapsed state and which includes a member which is arranged in a helical configuration with multiple helical turns, said member having multiple undulations, each having an unconfined apex;

delivering the stent to a selected site in a body lumen with the stent in said collapsed state; and

bending the stent along its longitudinal axis as it is being delivered to the selected site, and allowing apexes in one turn to move toward apexes in an adjacent turn in a substantially unrestricted manner.