Endoprosthesis deployment system for treating vascular bifurcations

• US 20030114912A1
• Filed: 08/20/2002
• Published: 06/19/2003
• Est. Priority Date: 05/30/2000
• Status: Active Grant

• Current Assignee: Biosensors International Group, Ltd.
• Original Assignee: DEVAX, Inc. (Biosensors International Group, Ltd.)
• Inventors: Elicker, Robert John, Laborde, Jean-Claude, Sequin, Jacques
• Granted Patent: US 7,238,197 B2
• Time in Patent Office: Days
• US Class Current: 623/1.11
• 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 comprising a pair of dissimilar stents, one of which is particularly suited for treating a widened portion of a blood vessel immediately proximal to a bifurcation. A stent delivery system including a handpiece adapted to selectively deliver the stents is also disclosed.

Claims

1. A method of deploying first and second stents in the vicinity of a vascular bifurcation of a main vessel into a first and a second branch vessels, comprising the steps of:

providing a delivery catheter having first and second stents thereon;

positioning the catheter such that the first and second stents are in the vicinity of the bifurcation; and

deploying the first stent in a branch vessel and the second stent in the main vessel;

wherein the second stent expands to a first diameter at a proximal end and a second, greater diameter at a distal end.

2. A method of deploying first and second stents in the vicinity of a vascular bifurcation as in claim 1, wherein the deploying step includes inflating a balloon within at least one of the stents.

3. A method of deploying first and second stents in the vicinity of a vascular bifurcation as in claim 1, wherein the deploying step comprises permitting at least one stent to self expand.

4. A method of deploying first and second stents in the vicinity of a vascular bifurcation as in claim 1, wherein the distal end of the second stent is positioned in proximity to the proximal end of the first stent.

5. A method of deploying first and second stents in the vicinity of a vascular bifurcation as in claim 4, wherein the distal end of the second stent expands to a greater diameter than the proximal end of the first stent.

6. A method of deploying first and second stents in the vicinity of a vascular bifurcation as in claim 5, wherein the distal end of the second stent expands to a diameter that is at least about 105% of the diameter of the proximal end of the first stent.

7. A method of deploying first and second stents in the vicinity of a vascular bifurcation as in claim 5, wherein the distal end of the second stent expands to a diameter that is at least about 110% of the diameter of the proximal end of the first stent.

8. A deployment system for treating a bifurcation of a main vessel and a first and second branch vessels, comprising:

an elongate, flexible body, having a proximal end and a distal end;

a first stent and a second stent carried by the distal end; and

a releasable restraint, for retaining the stents on the flexible body;

wherein the first stent has different dimensions in an unconstrained expanded configuration than the second stent.

9. A deployment system as in claim 8, further comprising a guidewire lumen extending axially through at least a portion of the flexible body.

10. A deployment system as in claim 9, wherein the guidewire lumen has a proximal access port and a distal access port, and the proximal access port is positioned along the flexible body, spaced distally apart from the proximal end.

11. A deployment system as in claim 9, wherein the guidewire lumen has a proximal access port and a distal access port, and the proximal access port is positioned at the proximal end of the flexible body.

12. A deployment system as in claim 9, wherein the releasable restraint comprises an axially movable control element extending along the length of the flexible body.

13. A deployment system as in claim 9, wherein the releasable restraint comprises a tubular sheath.

14. A deployment system as in claim 9, wherein the releasable restraint comprises a pull wire.

15. A deployment system as in claim 9, wherein the releasable restraint comprises a dissolvable media.

16. A deployment system as in claim 9, wherein the first and second stents have different expanded geometries.

17. A deployment system as in claim 9, wherein only one of the first and second stents expands into a cylindrical configuration in an unconstrained expansion.

18. A deployment system as in claim 17, wherein the first stent has a substantially cylindrical unconstrained expanded configuration, having a proximal end, a distal end and a substantially constant radius throughout.

19. A deployment system as in claim 18, wherein the second stent has an unconstrained expanded configuration in which a proximal end has a smaller diameter than a distal end.

20. A deployment system as in claim 19, wherein the expanded diameter of the second stent tapers radially outwardly in the distal direction.

21. A deployment system as in claim 9, wherein the first and second stents are carried by the catheter such that release of the stents from the catheter causes the proximal end of the first stent and the distal end of the second stent, as implanted, to be separated by a distance of no more than about 4 mm.

22. A deployment system as in claim 21, wherein the distance is no more than about 2 mm.

23. A deployment system as in claim 21, wherein the distance is no more than about 1 mm.

24. A method of treating a vascular bifurcation of a main vessel into first and second branch vessels, comprising the steps of:

deploying a substantially cylindrical stent in a first branch vessel; and

deploying a tapered stent in the main vessel;

wherein both of the substantially cylindrical stent and the tapered stent are deployed from the same catheter.

25. A method of treating a vascular bifurcation as in claim 24, wherein at least one of the substantially cylindrical stent and the tapered stent is deployed from a delivery catheter by proximally retracting an outer sheath on the delivery catheter.

26. A method of treating a vascular bifurcation as in claim 24, wherein the tapered stent has a relatively smaller diameter first end and a larger second end, and the cylindrical stent is positioned adjacent the second end.

27. A stent deployment catheter, comprising:

an elongate, flexible tubular body, having a proximal end and a distal end;

a first and a second stents carried by the distal end;

a handpiece on the proximal end;

a control on the handpiece, having a first position for indicating partial deployment of the first stent, and a second position indicating complete deployment of the first stent.

28. A stent deployment catheter as in claim 27, wherein the control further comprises a third position indicating partial deployment of the second stent.

29. A stent deployment catheter as in claim 28, wherein the control further comprises a fourth position indicating complete deployment of the second stent.

30. A method of treating a bifurcation of a main vessel into first and second branch vessels, comprising the steps of:

providing a catheter having a first and a second stents thereon;

positioning the catheter in the vicinity of the bifurcation;

partially deploying the first stent into the first branch vessel;

introducing contrast media to permit visualization of the location of the first stent; and

completely deploying the first stent into the first branch.

31. A method of treating a bifurcation as in claim 30, further comprising the step of partially deploying the second stent in the main vessel.

32. A method of treating a bifurcation as in claim 31, further comprising the step of introducing contrast media to permit visualization of the partially deployed second stent in the main vessel.

33. A method of treating a bifurcation as in claim 32, further comprising the step of completely deploying the second stent in the main vessel.

34. A method of treating a bifurcation as in claim 33, wherein the completely deploying the first stent step comprises proximally retracting a tubular sheath.

35. A method of treating a bifurcation as in claim 34, wherein the completely deploying the second stent step comprises proximally retracting the tubular sheath.

36. A stent deployment catheter, comprising:

an elongate, flexible body, having a proximal end and a distal end;

a first stent on the body, having a first configuration; and

a second stent on the body, having a second, different configuration.

37. A stent deployment catheter as in claim 36, further comprising an axially moveable tubular sheath, for restraining at least one stent.

38. A stent deployment catheter as in claim 36, further comprising at least one inflatable balloon, for expanding at least one stent.

39. A stent deployment catheter as in claim 38, further comprising a guidewire lumen extending axially through at least a portion of the flexible body.

40. A stent deployment catheter as in claim 39, wherein the guidewire lumen has a proximal access port and a distal access port, and the proximal access port is positioned along the flexible body, spaced distally apart from the proximal end.

41. A stent deployment catheter as in claim 39, wherein the guidewire lumen has a proximal access port and a distal access port, and the proximal access port is positioned at the proximal end of the flexible body.