Noncylindrical stent deployment system for treating vascular bifurcations

• US 20070100425A1
• Filed: 10/24/2006
• Published: 05/03/2007
• Est. Priority Date: 05/30/2000
• Status: Active Grant

• Current Assignee: Biosensors International Group, Ltd.
• Original Assignee: Jacques Sequin, Jean-Claude Laborde, Robert John Elicker
• Inventors: Elicker, Robert John, Laborde, Jean-Claude, Sequin, Jacques
• Granted Patent: US 7,686,845 B2
• Time in Patent Office: Days
• US Class Current: 623/1.110
• 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, comprising:

positioning a delivery catheter having a stent thereon, wherein the stent comprises an upstream end and a downstream end, 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 self expandable to a configuration having a single central lumen in which the upstream end has a smaller diameter than the downstream end; 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 than the downstream end, 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 stent is covered by a film.

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 12, wherein the film comprises polyester.

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 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.

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 is formed by folding and welding a sheet of nickel titanium alloy.

16. A method of treating a vascular bifurcation of a main vessel into a first branch vessel and a second branch vessel, 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 tapers in a downstream direction from a smaller upstream cross section to a larger downstream cross section which faces the bifurcation, and

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

17. A method of treating a vascular bifurcation of a main vessel into a first branch vessel and a second branch vessel as in claim 16, wherein deploying a tapered stent comprises removing a restraint from the tapered stent and permitting the tapered stent to self expand.

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 16, wherein the tapered stent comprises a nickel titanium alloy.

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 16, further comprising providing the tapered stent with a delivery catheter.

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 19, wherein the delivery catheter comprises a support core.

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 support core comprises an axial abutment adapted to permit axial immobilization of the tapered stent on the 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 20, wherein the support core comprises a longitudinally extending axial hole adapted to engage a guide wire.

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 19, further comprising providing an inflatable balloon on the delivery catheter.

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 19, further comprising providing a radiopaque marker 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 19, wherein the delivery catheter comprises a sheath.

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 19, further comprising providing a radiopaque markers on the 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 16, further comprising visualizing a location of the tapered stent during deployment.

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 16, wherein the tapered stent is covered by a film.

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 28, wherein the film comprises polyester.

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 16, wherein the tapered stent is formed by folding and welding a sheet of nickel titanium alloy.