Dilatation and stent delivery system and related methods

• US 20040230284A1
• Filed: 05/16/2003
• Published: 11/18/2004
• Est. Priority Date: 05/16/2003
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Abi-Kheirs, Michale, Damarati, John, Shank, Peter, Headley, F. Anthony, Rusk, Emily
• Granted Patent: US 7,947,070 B2
• Time in Patent Office: Days
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts

Abstract

The invention relates to a system for dilatation of a body passage and delivery of a stent into the body passage of a patient, and related methods of using such a system. The dilatation and stent delivery system may comprise a dilatation catheter having an expandable member on a distal end, and a stent delivery catheter configured to retain a stent and deliver the stent to a body passage. The stent delivery catheter defines a lumen sized to receive the dilatation catheter and permit movement of the dilatation catheter relative to the stent delivery catheter.

Claims

1. A dilatation and stent delivery system, the system comprising:

a dilatation catheter having an expandable member on a distal end; and

a stent delivery catheter configured to retain a stent and deliver the stent to a body passage, the stent delivery catheter defining a lumen sized to receive the dilatation catheter and permit movement of the dilatation catheter relative to the stent delivery catheter.

2. The system of claim 1, wherein the stent delivery catheter includes a locking mechanism at a proximal end for selectively restricting movement of at least a portion of the stent delivery catheter relative to the dilatation catheter.

3. The system of claim 1, wherein the stent delivery catheter includes an outer sheath, an inner shaft sized to be received in a lumen of the outer sheath, and a locking mechanism fixed to a proximal end of the inner shaft for selectively restricting movement of the inner shaft relative to the dilatation catheter.

4. The system of claim 3, wherein the locking mechanism is configured to selectively engage the dilatation catheter.

5. The system of claim 3, further comprising a handle at a proximal end of the inner shaft, wherein the locking mechanism is attached to a proximal end of the handle.

6. The system of claim 5, wherein the inner sheath terminates in the handle, and the locking mechanism defines a lumen to receive the dilatation catheter.

7. The system of claim 3, wherein the inner shaft includes a stent holder spaced from a distal end of the inner shaft and configured to retain the stent.

8. The system of claim 3, wherein the outer sheath moves relative to the inner shaft.

9. The system of claim 3, further comprising a first handle at a proximal end of the outer sheath and a second handle at the proximal end of the inner shaft.

10. The system of claim 1, wherein the expandable member is a balloon.

11. The system of claim 10, wherein the balloon expands to a plurality of distinct diameters corresponding to known inflation pressures.

12. The system of claim 1, wherein the dilatation catheter defines an inflation lumen for passing inflation fluid to the expandable member and a guide wire lumen for accommodating a guide wire.

13. The system of claim 1, wherein a length of the dilatation catheter is greater than a length of the stent delivery catheter.

14. The system of claim 1, wherein the stent delivery catheter includes an outer sheath and an inner shaft sized to be received in a lumen of the outer sheath, and the dilatation catheter includes a distal tip having a cross-sectional size at least as large as a cross-sectional size of the outer sheath.

15. The system of claim 1, further comprising a second expandable member at a distal end of the dilatation and stent delivery system.

16. The system of claim 15, wherein the second expandable member is located on a distal end of the stent delivery catheter.

17. The system of claim 15, wherein the second expandable member is located on the distal end of the dilatation catheter.

18. The system of claim 15, wherein the expandable member of the dilatation catheter expands to a first diameter, the second expandable member expands to a second diameter, and the second diameter is larger than the first diameter.

19. The system of claim 1, wherein the stent delivery catheter includes an outer sheath, and an inner shaft sized to be received in a lumen of the outer sheath and including a stent holder spaced from a distal end of the inner shaft and configured to retain the stent.

20. In combination, a stent and a dilatation and stent delivery system, the combination comprising:

a stent;

a dilatation catheter having an expandable member on a distal end; and

a stent delivery catheter configured to retain the stent and deliver the stent to a body passage, the stent delivery catheter defining a lumen sized to receive the dilatation catheter and permit movement of the dilatation catheter relative to the stent delivery catheter.

21. The combination of claim 20, wherein the stent is a self-expanding stent.

22. A method for implantation of a stent, the method comprising:

delivering a stent delivery catheter proximate to a treatment site in a body passage, the stent delivery catheter retaining the stent;

delivering a dilatation catheter proximate to the treatment site in the body passage, the dilatation catheter having an expandable member on a distal end;

implanting the stent at the treatment site, while at least a portion of the dilatation catheter is positioned within a lumen of the stent delivery catheter; and

expanding the expandable member to assist in expansion of the stent.

23. The method of claim 22, wherein the stent is implanted while the dilatation catheter is positioned proximate the treatment site.

24. The method of claim 22, wherein the expandable member is expanded to assist in expansion of the stent, while the stent delivery catheter is proximate the treatment site.

25. The method of claim 22, wherein the expandable member is expanded to assist in expansion of the stent, while at least a portion of the dilatation catheter is positioned within the lumen of the stent delivery catheter.

26. The method of claim 22, wherein the dilatation catheter is delivered proximate to the treatment site at the same time as the stent delivery catheter is delivered proximate to the treatment site.

27. The method of claim 22, wherein delivering the dilatation catheter and delivering the stent delivery catheter include the dilatation catheter reaching the treatment site prior to the stent delivery catheter reaching the treatment site.

28. The method of claim 22, wherein the dilatation catheter is delivered proximate to the treatment site after delivery of the stent delivery catheter proximate to the treatment site.

29. The method of claim 22, further comprising the step of expanding the expandable member to dilate the treatment site of the body passage, prior to implanting the stent.

30. The method of claim 29, wherein the expandable member is expanded to dilate the treatment site, while the stent delivery catheter is proximate the treatment site.

31. The method of claim 29, wherein the expandable member is expanded to dilate the treatment site, while at least a portion of the dilatation catheter is positioned within the lumen of the stent delivery catheter.

32. The method of claim 29, wherein the step of expanding the expandable member to dilate the treatment site is performed prior to delivering the stent delivery catheter proximate to the treatment site.

33. The method of claim 29, further comprising exposing the expandable member beyond a distal end of the stent delivery catheter prior to expanding the expandable member to dilate the treatment site.

34. The method of claim 33, further comprising withdrawing the expandable member into the distal end of the stent delivery catheter prior to the stent implanting step.

35. The method of claim 33, further comprising moving the distal end of the stent delivery catheter over the expandable member prior to the stent implanting step.

36. The method of claim 22, further comprising exposing the expandable member beyond a distal end of the stent delivery catheter prior to expanding the expandable member to assist in expansion of the stent.

37. The method of claim 22, further comprising restricting movement of the dilatation catheter relative to at least a portion of the stent delivery catheter.

38. The method of claim 37, wherein the stent delivery catheter includes an outer sheath, an inner shaft sized to be received in a lumen of the outer sheath, and a locking mechanism fixed to a proximal end of the inner shaft, and

wherein the restricting step includes actuating the locking mechanism to restrict movement of the inner shaft relative to the dilatation catheter.

39. The method of claim 37, wherein the restricting step occurs during the implanting step.

40. The method of claim 22, wherein the dilatation catheter includes a dilatation shaft and the expandable member is a balloon mounted on a distal end of the dilatation shaft, the stent delivery catheter includes an outer sheath and an inner shaft sized to be received in the outer sheath, the inner shaft defining a lumen sized to receive the dilatation shaft and permit movement of the dilatation shaft relative to the stent delivery catheter.

41. The method of claim 22, wherein the expandable member is inflatable.

42. The method of claim 22, further comprising expanding a second expandable member to expand an end of the stent.

43. The method of claim 42, wherein the second expandable member is located on a distal end of the stent delivery catheter.

44. The method of claim 42, wherein the expandable member on the distal end of the dilatation catheter is expanded to a first diameter and the second expandable member is expanded to a second diameter larger than the first diameter.

45. The method of claim 22, further comprising expanding a second expandable member to expand only a portion of the stent.

46. A method for implantation of a stent, the method comprising:

delivering a stent delivery catheter proximate to a treatment site in a body passage, the stent delivery catheter retaining the stent;

delivering a dilatation catheter proximate to the treatment site in the body passage, the dilatation catheter having an expandable member on a distal end;

implanting the stent at the treatment site, while movement of the dilatation catheter is restricted relative to at least a portion of the stent delivery catheter; and

expanding the expandable member to assist in expansion of the stent.

47. The method of claim 46, further comprising the step of expanding the expandable member to dilate the treatment site of the body passage, prior to implanting the stent.

48. The method of claim 47, wherein the expandable member is expanded to dilate the treatment site, while the stent delivery catheter is proximate the treatment site.

49. The method of claim 48, further comprising exposing the expandable member beyond a distal end of the stent delivery catheter prior to expanding the expandable member to dilate the treatment site of the body passage.

50. The method of claim 49, further comprising withdrawing the expandable member into the distal end of the stent delivery catheter prior to the stent implanting step.

51. The method of claim 49, further comprising moving the distal end of the stent delivery catheter over the expandable member prior to the stent implanting step.

52. The method of claim 47, wherein the expandable member is expanded to dilate the treatment site, while at least a portion of the dilatation catheter is positioned within the lumen of the stent delivery catheter.

53. The method of claim 47, wherein the step of expanding the expandable member to dilate the treatment site is performed prior to delivering the stent delivery catheter to the treatment site.

54. The method of claim 46, wherein the expandable member is expanded to assist in expansion of the stent, while the stent delivery catheter is proximate the treatment site.

55. The method of claim 46, wherein the stent is implanted, while the dilatation catheter is positioned proximate the treatment site.

56. The method of claim 46, wherein the expandable member is expanded to assist in expansion of the stent, while the stent delivery catheter is proximate the treatment site.

57. The method of claim 46, wherein the expandable member is expanded to assist in expansion of the stent, while at least a portion of the dilatation catheter is positioned within the lumen of the stent delivery catheter.

58. The method of claim 46, wherein the dilatation catheter is delivered proximate to the treatment site at the same time as the stent delivery catheter is delivered proximate to the treatment site.

59. The method of claim 46, wherein delivering the dilatation catheter and delivering the stent delivery catheter include the dilatation catheter reaching the treatment site prior to the stent delivery catheter reaching the treatment site.

60. The method of claim 46, wherein the dilatation catheter is delivered proximate to the treatment site after delivery of the stent delivery catheter proximate to the treatment site.

61. The method of claim 46, further comprising exposing the expandable member beyond a distal end of the stent delivery catheter prior to expanding the expandable member to assist in expansion of the stent.

62. The method of claim 46, wherein the stent delivery catheter includes an outer sheath, an inner shaft sized to be received in a lumen of the outer sheath, and a locking mechanism fixed to a proximal end of the inner shaft, and

movement of the dilatation catheter is restricted relative to at least a portion of the stent delivery catheter by actuating the locking mechanism to restrict movement of the inner shaft relative to the dilatation catheter.

63. The method of claim 46, wherein the dilatation catheter includes a dilatation shaft and the expandable member is a balloon mounted on a distal end of the dilatation shaft, the stent delivery catheter includes an outer sheath and an inner shaft sized to be received in the outer sheath, the inner shaft defining a lumen sized to receive the dilatation shaft and permit movement of the dilatation shaft relative to the stent delivery catheter.

64. The method of claim 46, wherein the expandable member is inflatable.

65. The method of claim 46, further comprising expanding a second expandable member to expand an end of the stent.

66. The method of claim 65, wherein the second expandable member is located on a distal end of the stent delivery catheter.

67. The method of claim 65, wherein the second expandable member is located on a distal end of the dilatation catheter.

68. The method of claim 65, wherein the first expandable member is expanded to a first diameter and the second expandable member is expanded to a second diameter larger than the first diameter.

69. The method of claim 46, further comprising expanding a second expandable member to expand only a portion of the stent.