Bifurcation stent delivery devices

• US 20050209673A1
• Filed: 07/27/2004
• Published: 09/22/2005
• Est. Priority Date: 03/04/2004
• Status: Abandoned Application

• Current Assignee: Y-Med, Inc. (Becton, Dickinson & Co)
• Original Assignee: Y-Med, Inc. (Becton, Dickinson & Co)
• Inventors: Shaked, Yoav
• Application Number:
  US10/899,034
• Publication Number:
  US 20050209673A1
• 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 bifurcations is provided. The system 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 side branch lumen, wherein the side branch 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 bifurcations and vessels.

Claims

1. 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.

2. The stent delivery system of claim 1, wherein said main elongated element is a catheter and said auxiliary elongated element is a side branch lumen.

3. The stent delivery system of claim 2, wherein said catheter includes a balloon.

4. The stent delivery system of claim 3, 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.

5. The stent delivery system of claim 1, wherein said main elongated element is a catheter and said auxiliary elongated element is a positioning system.

6. The stent delivery system of claim 5, wherein said positioning system comprises at least one stopper and an attachment mechanism.

7. The stent delivery system of claim 6, wherein said at least one stopper is a spring wire.

8. The stent delivery system of claim 6, 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.

9. The stent delivery system of claim 1, further comprising a stent with a side opening positioned on said main elongated element.

10. The stent delivery system of claim 9, wherein said side opening is a dedicated side opening.

11. The stent delivery system of claim 8, wherein said crotch point is located at a distal portion of said side opening of said stent.

12. The stent delivery system of claim 1, 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.

13. The stent delivery system of claim 1, 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.

14. The stent delivery system of claim 12, wherein said crotch point is located at said distal end of said proximal stent.

15. The stent delivery system of claim 1, wherein proximal to said crotch point, said bodies of said main and auxiliary elongated elements are attached.

16. The stent delivery system of claim 3, wherein said balloon is a tapered balloon.

17. The stent delivery system of claim 1, 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.

18. The stent delivery system of claim 1 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.

19. A stent delivery device, the device comprising:

a catheter having a distal end and a proximal end;

a balloon positioned on said catheter, the balloon having a distal end and a proximal end, wherein said balloon is immovable with respect to said catheter;

a wire attached to said distal end of said balloon; and

a side element having a distal end and a proximal end, said side element at least partially attached to said balloon.

20. The stent delivery device of claim 19, further comprising a stent with a side hole, said stent positioned on said balloon, said side hole having a distal end and a proximal end, and wherein said proximal end of said side element is attached to said catheter and said distal end of said side element is positioned alongside said balloon, and wherein a crotch point is defined at a location wherein at said crotch point, said side element is attached to said balloon, and wherein said crotch point is located at said distal end of said side hole.

21. The stent delivery device of claim 20, wherein said side hole is a dedicated side hole.

22. The stent delivery device of claim 19, wherein said proximal end of said side branch lumen is positioned within said catheter.

23. The stent delivery device of claim 20, wherein said distal end of said side element is located distal to said crotch point, and wherein said distal end of said side element is unattached to said catheter.

24. The stent delivery device of claim 19, wherein said balloon is a tapered balloon.

25. The stent delivery device of claim 19, further comprising a stent positioned on said balloon, wherein said proximal end of said side element is attached to said catheter, and wherein a crotch point is defined at a location wherein at said crotch point, said side element is attached to said balloon, and wherein said crotch point is located at said proximal end of said balloon.

26. The stent delivery system of claim 25, wherein said distal end of said side element is located proximal to said crotch point, and wherein said distal end of said side element is unattached to said catheter.

27. The stent delivery system of claim 19, wherein said side element is a side branch lumen.

28. The stent delivery system of claim 19, wherein said side element is a stopper.

29. The stent delivery device of claim 19, wherein said balloon is a proximal balloon, and further comprising a distal balloon positioned on said catheter distal to said proximal balloon.

30. The stent delivery device of claim 29, wherein said distal balloon and said proximal balloon may be inflated separately.

31. The stent delivery device of claim 29, further comprising a distal stent positioned on said distal balloon, said distal stent having a proximal end and a distal end, and a proximal stent positioned on said proximal balloon, said proximal stent having a proximal end and a distal end.

32. The stent delivery device of claim 31, wherein said side element is at least partially attached to said proximal balloon.

33. The stent delivery device of claim 32, wherein a crotch point is defined at a location wherein at said crotch point, said side element is attached to said proximal balloon, and wherein said crotch point is located at a distal end of said proximal balloon.

34. The stent delivery device of claim 19, wherein an outer diameter of said system is less than 1 mm.

35. A stent delivery system, the system comprising:

a catheter having a distal end and a proximal end;

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

a wire attached to said distal end of said balloon;

a side element having a distal end and a proximal end, said side element at least partially attached to said balloon; and

a crotch point, wherein at said crotch point, said side element and said balloon are attached, and wherein a location of said crotch point is configured to stop advancement of said system upon reaching a bifurcation.

36. The stent delivery system of claim 35, wherein said balloon is a tapered balloon.

37. The stent delivery system of claim 35, 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.

38. The stent delivery system of claim 35, wherein said side element is a positioning system.

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

40. The stent delivery system of claim 39, wherein said at least one stopper is a spring wire.

41. The stent delivery system of claim 39, 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.

42. The stent delivery system of claim 35, further comprising a stent with a side opening positioned on said catheter.

43. The stent delivery system of claim 42, wherein said side opening is a dedicated side opening.

44. The stent delivery system of claim 42, wherein said crotch point is located at a distal portion of said side opening of said stent.

45. The stent delivery system of claim 35, further comprising a stent having a proximal end and a distal end, said stent positioned on said catheter, and wherein said crotch point is located at said proximal end of said stent.

46. The stent delivery system of claim 35, 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 catheter and said distal stent positioned distal to said proximal stent on said catheter.

47. The stent delivery system of claim 46, wherein said crotch point is located at said distal end of said proximal stent.

48. The stent delivery system of claim 35, wherein proximal to said crotch point, said catheter and said side element are attached.

49. The stent delivery system of claim 35, wherein said proximal end of said side element is positioned within said catheter.

50. The stent delivery system of claim 35, wherein said distal end of said side element is located distal to said crotch point, and wherein said distal end of said side element is unattached to said catheter.

51. The stent delivery system of claim 35, wherein said side element is a side branch lumen.

52. The stent delivery system of claim 35, wherein said side element is a stopper.

53. The stent delivery device of claim 35, wherein said balloon is a proximal balloon, and further comprising a distal balloon positioned on said catheter distal to said proximal balloon.

54. The stent delivery device of claim 53, wherein said distal balloon and said proximal balloon may be inflated separately.

55. The stent delivery system of claim 35, wherein an outer diameter of said system is less than 1 mm.

59. The stent delivery system of claim 55, wherein said balloon comprises a fixed wire at a distal end thereof.

60. The stent delivery system of claim 55, further comprising a distal connecting element at said distal end of said balloon.

61. The stent delivery system of claim 60, wherein said distal connecting element lies on a same side of said catheter as said side branch lumen, and is configured for receiving a side branch guidewire, said side branch guidewire positionable through both said side branch lumen and said distal connecting element.

62. The stent delivery system of claim 60, wherein said distal connecting element lies on an opposite side of said catheter as said side branch lumen, and is configured for receiving a main guidewire, said main guidewire positionable through said distal connecting element and outside of said stent.

56. A stent delivery system, the system comprising:

a catheter having a distal end and a proximal end;

a balloon positioned on said distal end of said catheter, the balloon having a distal end and a proximal end, and wherein said balloon is immovable with respect to said catheter;

a stent positioned on said balloon, said stent having a side opening, wherein the side opening has a proximal end and a distal end; and

a side branch lumen having a distal end and a proximal end, wherein said proximal end is attached to a proximal end of said balloon, and wherein said distal end is positioned at said side opening of said stent.

57. The stent delivery system of claim 56, wherein said balloon is a tapered balloon.

58. The stent delivery system of claim 56, wherein said proximal end of said side branch lumen is positioned within said catheter, and wherein said distal end of said side branch lumen which is detached from said balloon is positioned outside of said catheter.

63. 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.

64. The stent delivery system of claim 63, wherein said auxiliary elongated element is a side branch lumen.

65. The stent delivery system of claim 63, further comprising a fixed wire balloon at said distal end of said catheter.

66. The stent delivery system of claim 63, further comprising a tapered balloon at said distal end of said catheter.

67. The stent delivery system of claim 63, wherein said auxiliary elongated element is a positioning system.

68. The stent delivery system of claim 67, wherein said positioning system comprises at least one stopper and an attachment mechanism.

69. The stent delivery system of claim 67, wherein said at least one stopper is a spring wire comprising a shape-memory metal.

70. The stent delivery system of claim 63, wherein said attachment mechanism is a jacket for holding a proximal end of said at least one spring wire in place.

71. The stent delivery system of claim 63, further comprising a holder for holding a distal end of said at least one spring wire in place.

72. 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.

73. The stent delivery system of claim 72, wherein said auxiliary elongated element is a side branch lumen.

74. The stent delivery system of claim 72, wherein said distal balloon has a fixed wire at said distal end of said distal balloon.

75. The stent delivery system of claim 72, further comprising a distal stent positioned on said distal balloon.

76. The stent delivery system of claim 72, wherein said stent and said distal stent separately deployable.

77. The stent delivery system of claim 72, wherein said distal stent has a smaller outer diameter than said proximal stent.

78. The stent delivery system of claim 72, wherein said proximal end of said auxiliary elongated element is positioned within said catheter.

79. The stent delivery system of claim 72, 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.

80. A catheter system comprising:

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

a side branch lumen having a distal end, a proximal end and a body connecting said distal and proximal ends, wherein a first portion of said side branch lumen is positioned inside said body of said catheter, and a second portion of said side branch 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.

81. The catheter system of claim 80, further comprising a crotch point, wherein at said crotch point said side branch lumen is attached to said catheter, and wherein said crotch point is located on said second portion of said side branch lumen.

82. The catheter system of claim 81, wherein said crotch point is located at said distal end of said side branch lumen.

83. The catheter system of claim 81, wherein said crotch point is located proximal to said distal end of said side branch lumen.

84. The catheter system of claim 80, further comprising a balloon on said distal end of said catheter.

85. The catheter system of claim 84, wherein said balloon is a fixed wire balloon.

86. The catheter system of claim 84, wherein said balloon is a tapered balloon.

87. 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.

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

providing a stent delivery system, wherein the system comprises;

a catheter having a balloon at a distal end thereof;

a fixed wire at a distal end of said balloon; and

a side branch lumen at least partially attached to said catheter, wherein a point of attachment defines a stopping point; and

advancing said stent delivery system through a main vessel until a location at which said advancing automatically stops due to said crotch point reaching said bifurcation.