Noncylindrical stent deployment system for treating vascular bifurcations

• US 7,686,845 B2
• Filed: 10/24/2006
• Issued: 03/30/2010
• Est. Priority Date: 05/30/2000
• Status: Expired due to Fees

• Current Assignee: Biosensors International Group, Ltd.
• Original Assignee: DEVAX, Inc. (Biosensors International Group, Ltd.)
• Inventors: Sequin, Jacques, Elicker, Robert John, Laborde, Jean-Claude
• Primary Examiner(s): McDermott; Corrine M
• Assistant Examiner(s): STEWART, JASON-DENNIS NEILKEN
• Application Number:
  US11/586,023
• Publication Number:
  US 20070100425A1
• Time in Patent Office: 1,253 Days
• Field of Search: 623/1.16, 623/1.35, 606/108
• US Class Current: 623/1.35
• CPC Class Codes: A61F 2/856 Single tubular stent with a side portal passage
• 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 2/915 with bands having a meander structure, adjacent bands being connected to each other
• 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 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2/9661 the proximal portion of the stent or stent-graft is released first
• CPC Class Codes: A61F 2002/067 modular
• CPC Class Codes: A61F 2002/91541 Adjacent bands are arranged out of phase
• CPC Class Codes: A61F 2002/9583 Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded

Abstract

A device and method for treating pathological narrowing of fluid-carrying conduits of the human body (such as blood vessels) in an area of a bifurcation is disclosed. In particular, a stent system carries a self expandable noncylindrical stent, which is particularly suited for treating a widened portion of a blood vessel immediately proximal to a bifurcation. A stent delivery system is also disclosed, for delivering the stent such that a larger expanded diameter end of the stent faces the bifurcation, and a smaller expanded diameter end of the stent faces proximally in the main vessel.

Claims

1. A method of treating a vascular bifurcation of a main vessel into a first branch vessel and a second branch vessel, wherein blood flows from the main vessel into the first and second branch vessels in a downstream direction, comprising:

positioning a delivery catheter having a stent thereon, wherein the stent comprises an upstream end and a downstream end and a central axis, such that the stent is at a treatment site within the main vessel with the downstream end adjacent the vascular bifurcation,

wherein the stent is uncovered and self expandable to a configuration having a single central lumen in which the upstream end has a smaller diameter with respect to the central axis than the downstream end diameter with respect to the central axis; and

deploying the stent in the main vessel by retracting an outer sheath of the delivery catheter, such that the stent self expands to a configuration in which the upstream end has a smaller cross sectional area with respect to the central axis than the downstream end with respect to the central axis, and in which the downstream end communicates with both the first branch vessel and the second branch vessel.

2. A method of treating a vascular bifurcation of a main vessel into a first branch vessel and a second branch vessel as in claim 1, further comprising deploying a first branch stent into the first branch vessel.

3. A method of treating a vascular bifurcation of a main vessel into a first branch vessel and a second branch vessel as in claim 2, further comprising deploying a second branch stent into the second branch vessel.

4. A method of treating a vascular bifurcation of a main vessel into a first branch vessel and a second branch vessel as in claim 1, wherein the stent comprises a nickel titanium alloy.

5. A method of treating a vascular bifurcation of a main vessel into a first branch vessel and a second branch vessel as in claim 1, wherein the delivery catheter further comprises a support core.

6. A method of treating a vascular bifurcation of a main vessel into a first branch vessel and a second branch vessel as in claim 5, wherein the support core comprises an axial abutment adapted to permit axial immobilization of the stent on the support core.

7. A method of treating a vascular bifurcation of a main vessel into a first branch vessel and a second branch vessel as in claim 5, wherein the support core comprises a longitudinally extending axial hole adapted to engage a guide wire.

8. A method of treating a vascular bifurcation of a main vessel into a first branch vessel and a second branch vessel as in claim 1, further comprising providing an inflatable balloon on the delivery catheter.

9. A method of treating a vascular bifurcation of a main vessel into a first branch vessel and a second branch vessel as in claim 1, further comprising providing radiopaque markers on the delivery catheter.

10. A method of treating a vascular bifurcation of a main vessel into a first branch vessel and a second branch vessel as in claim 1, further comprising providing radiopaque markers on the outer sheath.

11. A method of treating a vascular bifurcation of a main vessel into a first branch vessel and a second branch vessel as in claim 1, further comprising visualizing the location of the stent during deployment.

12. A method of treating a vascular bifurcation of a main vessel into a first branch vessel and a second branch vessel as in claim 1, wherein the deploying step further comprises expanding the stent to a shape that corresponds to a transitional zone between the main vessel and the first and second branch vessels.

13. A method of treating a vascular bifurcation of a main vessel into a first branch vessel and a second branch vessel as in claim 1, wherein the stent is formed by folding and welding a sheet of nickel titanium alloy.

14. A method of treating a vascular bifurcation of a main vessel into a first branch vessel and a second branch vessel as in claim 1, wherein the stent self expands to a substantially conical shape when deployed.

15. A method of treating a vascular bifurcation of a main vessel into a first branch vessel and a second branch vessel as in claim 1, wherein the stent self expands to a substantially funnel shape when deployed.

16. A method of treating a vascular bifurcation of a main vessel into a first branch vessel and a second branch vessel as in claim 1, wherein the stent self expands to a frustoconical form when deployed.

17. A method of treating a vascular bifurcation of a main vessel into a first branch vessel and a second branch vessel, wherein blood flows from the main vessel into the first and second branch vessels in a downstream direction, comprising:

deploying a branch stent in a first branch vessel that is downstream from the bifurcation; and

deploying a tapered stent in the main vessel, upstream from the bifurcation,

wherein the tapered stent has a single central lumen and a central axis, and tapers in a downstream direction from a smaller upstream cross section with respect to the central axis to a larger downstream cross section with respect to the central axis, wherein the larger downstream cross section faces the bifurcation, and

wherein the tapered stent expands to correspond to a shape of the bifurcation.

18. A method of treating a vascular bifurcation of a main vessel into a first branch vessel and a second branch vessel as in claim 17, wherein deploying a tapered stent comprises removing a restraint from the tapered stent and permitting the tapered stent to self expand.

19. A method of treating a vascular bifurcation of a main vessel into a first branch vessel and a second branch vessel as in claim 17, wherein the tapered stent comprises a nickel titanium alloy.

20. A method of treating a vascular bifurcation of a main vessel into a first branch vessel and a second branch vessel as in claim 17, further comprising providing the tapered stent with a delivery catheter.

21. A method of treating a vascular bifurcation of a main vessel into a first branch vessel and a second branch vessel as in claim 20, wherein the delivery catheter comprises a support core.

22. A method of treating a vascular bifurcation of a main vessel into a first branch vessel and a second branch vessel as in claim 21, wherein the support core comprises an axial abutment adapted to permit axial immobilization of the tapered stent on the support core.

23. A method of treating a vascular bifurcation of a main vessel into a first branch vessel and a second branch vessel as in claim 21, wherein the support core comprises a longitudinally extending axial hole adapted to engage a guide wire.

24. A method of treating a vascular bifurcation of a main vessel into a first branch vessel and a second branch vessel as in claim 20, further comprising providing an inflatable balloon on the delivery catheter.

25. A method of treating a vascular bifurcation of a main vessel into a first branch vessel and a second branch vessel as in claim 20, further comprising providing a radiopaque marker on the delivery catheter.

26. A method of treating a vascular bifurcation of a main vessel into a first branch vessel and a second branch vessel as in claim 20, wherein the delivery catheter comprises a sheath.

27. A method of treating a vascular bifurcation of a main vessel into a first branch vessel and a second branch vessel as in claim 20, further comprising providing a radiopaque markers on the sheath.

28. A method of treating a vascular bifurcation of a main vessel into a first branch vessel and a second branch vessel as in claim 17, further comprising visualizing a location of the tapered stent during deployment.

29. A method of treating a vascular bifurcation of a main vessel into a first branch vessel and a second branch vessel as in claim 17, wherein the tapered stent is covered by a film.

30. A method of treating a vascular bifurcation of a main vessel into a first branch vessel and a second branch vessel as in claim 29, wherein the film comprises polyester.

31. A method of treating a vascular bifurcation of a main vessel into a first branch vessel and a second branch vessel as in claim 17, wherein the tapered stent is formed by folding and welding a sheet of nickel titanium alloy.

32. A method of treating a vascular bifurcation of a main vessel into a first branch vessel and a second branch vessel as in claim 17, wherein the stent expands to a substantially conical shape when deployed.

33. A method of treating a vascular bifurcation of a main vessel into a first branch vessel and a second branch vessel as in claim 17, wherein the stent expands to a substantially funnel shape when deployed.

34. A method of treating a vascular bifurcation of a main vessel into a first branch vessel and a second branch vessel as in claim 17, wherein the stent expands to a frustoconical form when deployed.