Stent delivery devices

• US 20050209677A1
• Filed: 03/03/2005
• Published: 09/22/2005
• Est. Priority Date: 03/04/2004
• Status: Active Grant

• Current Assignee: Y-Med, Inc. (Becton, Dickinson & Co)
• Original Assignee: Y-Med, Inc. (Becton, Dickinson & Co)
• Inventors: Shaked, Yoav
• Granted Patent: US 7,438,720 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 2/954 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 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61M 2025/0186 Catheters with fixed wires, i.e. so called "non-over-the-wire catheters"
• CPC Class Codes: A61M 2025/1045 for treating bifurcations, e.g. balloons in y-configuration, separate balloons or special features of the catheter for treating bifurcations
• CPC Class Codes: A61M 2025/1056 having guide wire lumens outside the main shaft, i.e. the guide wire lumen is within or on the surface of the balloon
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters

Abstract

A stent delivery system for treating lesions is provided. The system is suitable for treatment of bifurcation lesions, has a low profile and provides substantially predictable translational and rotational positioning. In one embodiment, the system includes a fixed wire balloon catheter and a partially attached guidewire lumen, wherein the guidewire lumen is attached to the catheter at a crotch point. The location of the crotch point is predetermined so as to provide substantially predictable positioning. Several embodiments of the system are described for various types of lesions and vessel configurations.

Claims

1. A stent delivery device, the device comprising:

a catheter having a distal end and a proximal end, said proximal end comprising a rigid member;

a fixed wire balloon positioned on said catheter, said balloon having a proximal end, a distal end, and an inflation lumen therethrough;

a core wire positioned in said inflation lumen, said core wire extending from a distal end of said rigid member to said distal end of said balloon, said core wire at least partially attached to said catheter; and

a guidewire lumen positioned alongside said balloon.

2. The stent delivery system of claim 1, wherein a crotch point is defined at a location wherein at said crotch point, said guidewire lumen is attached to said balloon.

3. The stent delivery system of claim 2, wherein said crotch point is located at said distal end of said balloon.

4. The stent delivery system of claim 2, wherein said crotch point is located at said proximal end of said balloon.

5. The stent delivery system of claim 2, further comprising a stent with a side hole, and wherein said crotch point is located at a distal end of said side hole.

6. The stent delivery device of claim 1, wherein said core wire at least partially attached to said catheter comprises a first attachment point at said distal end of said rigid member;

a second attachment point at said distal end of said balloon; and

at least one other attachment point at a location between said first and second attachment points.

7. The stent delivery device of claim 1, wherein a proximal end of said guidewire lumen is positioned within said catheter.

8. The stent delivery device of claim 1, wherein said core wire has a diameter within a range of 0.009-0.012 inches.

9. The stent delivery system of claim 1, wherein said guidewire lumen is a side branch guidewire lumen.

10. The stent delivery device of claim 1, wherein said fixed wire balloon is a distal balloon, and further comprising a proximal balloon positioned on said catheter proximal to said distal balloon.

11. The stent delivery device of claim 10, wherein said distal balloon and said proximal balloon may be inflated separately.

12. The stent delivery device of claim 10, further comprising a distal stent positioned on said distal balloon and a proximal stent positioned on said proximal balloon.

13. The stent delivery device of claim 1, wherein an outer diameter of said device is less than 1 mm.

14. A stent delivery system, the system comprising:

a main elongated element for advancement within a main vessel, said main elongated element comprising;

a proximal end;

a distal end; and

a body connecting said proximal and distal ends;

an auxiliary elongated element for advancement within an auxiliary vessel, said auxiliary elongated element comprising;

a proximal end; and

a distal end,

said auxiliary elongated element partially attached to said main elongated element; and

a crotch point, wherein at said crotch point, said body of said main elongated element is attached to said auxiliary elongated element, and wherein a location of said crotch point is configured to stop advancement of said system upon reaching a bifurcation.

15. The stent delivery system of claim 14, wherein said main elongated element is a catheter and said auxiliary elongated element is a guidewire lumen.

16. The stent delivery system of claim 15, wherein said catheter includes a balloon.

17. The stent delivery system of claim 15, wherein said catheter is selected from the group consisting of a fixed wire balloon catheter, an over-the-wire catheter and a rapid exchange catheter.

18. The stent delivery system of claim 14, wherein said main elongated element is a catheter and said auxiliary elongated element is a positioning system.

19. The stent delivery system of claim 18, wherein said positioning system comprises at least one stopper and an attachment mechanism.

20. The stent delivery system of claim 19, wherein said at least one stopper is a spring wire.

21. The stent delivery system of claim 19, wherein said attachment mechanism is a polymer jacket, and wherein said polymer jacket is configured to hold a proximal portion of said at least one stopper in place, and wherein a distal end of said polymer jacket defines said crotch point.

22. The stent delivery system of claim 14, further comprising a stent with a side opening positioned on said main elongated element.

23. The stent delivery system of claim 22, wherein said side opening is a dedicated side opening.

24. The stent delivery system of claim 22, wherein said crotch point is located at a distal portion of said side opening of said stent.

25. The stent delivery system of claim 14, further comprising a stent having a proximal end and a distal end, said stent positioned on said main elongated element, and wherein said crotch point is located at said proximal end of said stent.

26. The stent delivery system of claim 14, further comprising a stent having a proximal end and a distal end, said stent positioned on said main elongated element, and wherein said crotch point is located at said distal end of said stent.

27. The stent delivery system of claim 14, further comprising a proximal stent comprising a proximal end and a distal end and a distal stent comprising a proximal end and a distal end, said proximal stent positioned on said main elongated element and said distal stent positioned distal to said proximal stent on said main elongated element.

28. The stent delivery system of claim 27, wherein said crotch point is located at said distal end of said proximal stent.

29. The stent delivery system of claim 14, wherein proximal to said crotch point, said bodies of said main and auxiliary elongated elements are attached.

30. The stent delivery system of claim 16, wherein said balloon is a tapered balloon.

31. The stent delivery system of claim 14, wherein said proximal end of said auxiliary elongated element is positioned within said main elongated element, and further comprising an exit point, wherein distal to said exit point said auxiliary elongated element is external to said main elongated element.

32. The stent delivery system of claim 14 wherein a distal end of said auxiliary elongated element is located distal to said crotch point, and wherein said distal end of said auxiliary elongated element is unattached to said main elongated element.

33. A stent delivery system, the system comprising:

a catheter having a distal end and a proximal end;

a stent positioned on said catheter, the stent having a distal end and a proximal end;

an auxiliary elongated element having a distal end and a proximal end, said auxiliary elongated element positioned outside of said stent; and

a crotch point located at said proximal end of said stent wherein said auxiliary elongated element is attached to said catheter at said crotch point.

34. The stent delivery system of claim 33, wherein said auxiliary elongated element 10 is a side branch lumen.

35. The stent delivery system of claim 33, further comprising a fixed wire balloon at said distal end of said catheter.

36. The stent delivery system of claim 33, further comprising a tapered balloon at said distal end of said catheter.

37. The stent delivery system of claim 33, wherein said auxiliary elongated element is a positioning system.

38. The stent delivery system of claim 37, wherein said positioning system comprises at least one stopper and an attachment mechanism.

39. The stent delivery system of claim 38, wherein said at least one stopper is a spring wire comprising a shape-memory metal.

40. The stent delivery system of claim 38, wherein said attachment mechanism is a jacket for holding a proximal end of said at least one spring wire in place.

41. A stent delivery system, the system comprising:

a catheter having a distal end and a proximal end;

a stent positioned on said catheter, the stent having a distal end and a proximal end;

an auxiliary elongated element having a distal end and a proximal end, said auxiliary elongated element positioned between said stent and said catheter; and

a crotch point located at said distal end of said stent wherein said auxiliary elongated element is attached to said catheter at said crotch point.

42. The stent delivery system of claim 41, wherein said auxiliary elongated element is a guidewire lumen.

43. The stent delivery system of claim 41, further comprising a fixed wire balloon at said distal end of said catheter.

44. The stent delivery system of claim 43, further comprising a core wire positioned through said fixed wire balloon, said core wire at least partially attached to said balloon.

45. A stent delivery system, the system comprising:

a catheter having a distal end and a proximal end;

a distal balloon positioned on said distal end of said catheter, the distal balloon having a distal end and a proximal end;

a proximal balloon positioned on said catheter proximal to said distal balloon;

a stent positioned on said proximal balloon, the stent having a distal end and a proximal end;

an auxiliary elongated element having a distal end and a proximal end, said auxiliary elongated element positioned inside of said stent and exiting at said distal end of said stent; and

a crotch point located at said distal end of said stent wherein said auxiliary elongated element is attached to said balloon at said crotch point.

46. The stent delivery system of claim 45, wherein said auxiliary elongated element is a side branch lumen.

47. The stent delivery system of claim 45, wherein said distal balloon has a fixed wire at said distal end of said distal balloon.

48. The stent delivery system of claim 45, further comprising a distal stent positioned on said distal balloon.

49. The stent delivery system of claim 48, wherein said stent and said distal stent are separately deployable.

50. The stent delivery system of claim 48, wherein said distal stent has a smaller outer diameter than said proximal stent.

51. The stent delivery system of claim 45, wherein said proximal end of said auxiliary elongated element is positioned within said catheter.

52. The stent delivery system of claim 45, wherein said distal end of said auxiliary elongated element is located distal to said crotch point and wherein said distal end of said auxiliary elongated element is unattached to said catheter.

53. A catheter system comprising:

a catheter having a distal end, a proximal end and a body connecting said distal and proximal ends;

a guidewire lumen having a distal end, a proximal end and a body connecting said distal and proximal ends, wherein a first portion of said guidewire lumen is positioned inside said body of said catheter, and a second portion of said guidewire lumen is positioned outside said body of said catheter; and

an exit point located on said body of said catheter wherein said first portion is proximal to said exit point and said second portion is distal to said exit point.

54. The catheter system of claim 53, further comprising a crotch point, wherein at said crotch point said guidewire lumen is attached to said catheter, and wherein said crotch point is located on said second portion of said guidewire lumen.

55. The catheter system of claim 53, wherein said crotch point is located at said distal end of said guidewire lumen.

60. The catheter system of claim 53, wherein said crotch point is located proximal to said distal end of said guidewire lumen.

61. The catheter system of claim 53, further comprising a balloon on said distal end of said catheter.

62. The catheter system of claim 61, wherein said balloon is a fixed wire balloon.

63. The catheter system of claim 62, and further comprising a core wire positioned through and at least partially attached to said balloon.

64. A method for treating a bifurcation, the method comprising:

introducing a side branch guidewire into a branch vessel;

providing a stent delivery system, wherein the system comprises;

a main elongated element for advancement within a main vessel, said main elongated element having a proximal end, a distal end, and a body connecting said proximal and distal ends;

a side branch element for advancement within said side branch vessel, said side branch element having a body which is partially attached to said main elongated element;

a crotch point, wherein at said crotch point, said bodies of said main and side branch elements are attached, and wherein a location of said crotch point is configured to stop advancement of said system at a bifurcation; and

a stent positioned on said main elongated element;

inserting a proximal end of said side branch guidewire into said distal end of said side branch lumen;

advancing said stent delivery system over said side branch guidewire until a location at which said advancing automatically stops due to said crotch point reaching said bifurcation; and

deploying said stent.

65. A method for treating a lesion in a vessel by direct stenting, the method comprising:

providing a stent delivery system, the system comprising a catheter having a fixed wire balloon, a core wire positioned through said balloon, a guidewire lumen positioned at least partially alongside said balloon, and a stent positioned on said balloon;

inserting a guidewire into the vessel and through said lesion;

placing a proximal end of said guidewire into said guidewire lumen;

advancing said stent delivery system of the guidewire until said stent is positioned at said lesion; and

deploying said stent.

66. A method for treating a lesion in a vessel, the method comprising:

providing a stent delivery system, the system comprising a catheter having a fixed wire balloon, a core wire positioned through said balloon, a guidewire lumen positioned at least partially alongside said balloon, and a stent positioned on said balloon;

providing a guidewire in said guidewire lumen;

advancing said stent delivery system through said vessel;

introducing said fixed wire through the lesion until said stent is positioned at said lesion; and

deploying said stent.