Stent and catheter assembly and method for treating bifurcations

• US 6,749,628 B1
• Filed: 05/17/2001
• Issued: 06/15/2004
• Est. Priority Date: 05/17/2001
• Status: Expired due to Term

• Current Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Inventors: Cho, Brenda, Chi, David, Valencia, Hans F., Callol, Joseph R., Brandt, Brian D., Wilson, W. Stan, Matin, Nazanine, Bigus, Steve
• Primary Examiner(s): Thaler, Michael H.
• Application Number:
  US09/861,473
• Time in Patent Office: 1,125 Days
• Field of Search: 623/1.15, 623/1.35, 623/1.16, 606/198
• US Class Current: 623/1.15
• CPC Class Codes: A61F 2/852 Two or more distinct overlapping stents
• 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 2/954 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 2002/91516 the meander having a change in frequency along the band
• CPC Class Codes: A61F 2002/91525 within the whole structure different bands showing different meander characteristics, e.g. frequency or amplitude
• CPC Class Codes: A61F 2002/91533 characterised by the phase between adjacent bands
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2002/91575 connected peak to trough
• CPC Class Codes: A61F 2002/91591 Locking connectors, e.g. using male-female connections
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/006 modular

Abstract

The present invention provides for an improved stent design and stent delivery catheter assembly for repairing a main vessel and a side branch vessel forming a bifurcation. The present invention includes a trap door stent design, a stent delivery catheter assembly, an apparatus for crimping the stent and the method for crimping the stent onto the catheter assembly, and the method for delivering and implanting the stent in a bifurcated vessel. More particularly, the invention relates to a stent having rings aligned along a common longitudinal axis and connected by links, where the stent has a proximal section, a distal section and a central section. The number of rings and the expanded diameter of the sections is varied to create a “trap door” capable of expanding to a slightly larger diameter than the proximal section and distal section of the stent. The stent is implanted at a bifurcation so that the proximal section and distal section are in the main vessel, and the central section covers at least a portion of the opening to the side branch vessel. A second stent can be implanted in the side branch vessel and abut the expanded central section to provide full coverage of the bifurcated area in the main vessel and the side branch vessel.

Claims

1. A stent for treating a bifurcated vessel having a main vessel and a side branch vessel, comprising:

a. a cylindrical body having a plurality of rings aligned along a common longitudinal axis, adjacent rings being connected by links;

b. each ring having a delivered diameter and an implanted diameter and a plurality of first peaks and second peaks configured to spread apart to permit the rings to expand radially outwardly or compress radially inwardly;

c. each link having a link distal end connected to a valley and a link proximal end connected to the second peak;

d. the cylindrical body having a proximal section, a distal section, and a central section;

e. the proximal section having between one and fifteen rings;

f. the distal section having between one and fifteen rings;

g. the central section having between one and ten rings;

h. the number of first peaks in the central section differing from the number of first peaks in the proximal section and the distal section to thereby provide additional material for apposing a side branch vessel;

i. wherein the proximal section, the distal section, and the central section are configured to be used with two balloons such that a first balloon extends through the proximal, distal and central sections, and a second balloon extends through the proximal and central sections; and

j. the central section first peaks being configured to flare radially outwardly into contact with an opening to the side branch vessel and into at least a portion of the side branch vessel.

2. The stent of claim 1, wherein the rings of the proximal section have between four and twelve first peaks, the rings of the distal section have between four and twelve first peaks, and the rings of the central section have between five and fifteen first peaks.

3. The stent of claim 1, wherein the rings of the proximal section have seven first peaks, the rings of the distal section have six first peaks, and the rings of the central section have eight first peaks.

4. The stent of claim 1, wherein the number of first peaks in the ring(s) of the central section is greater than the number of first peaks in any of the rings in either the proximal section or the distal section.

5. The stent of claim 1, wherein the rings are connected by at least one link between adjacent rings.

6. The stent of claim 5, wherein at least some of the links have a straight segment.

7. The stent of claim 5, wherein at least some of the links have a curved segment.

8. The stent of claim 5, wherein at least some of the links have a straight segment and a curved segment.

9. The stent of claim 5, wherein at least some of the links have a non-linear segment.

10. The stent of claim 1, wherein the tubular body has a distal opening, a proximal opening, and a central opening.

11. The stent of claim 10, wherein the distal opening and the proximal opening are aligned along the stent longitudinal axis.

12. The stent of claim 11, wherein the central opening is radially offset relative to the alignment of the distal opening and the proximal opening.

13. The stent of claim 1, wherein each ring has at least one second peak.

14. The stent of claim 13, wherein at least some of the at least one second peaks is connected to a link.

15. The stent of claim 1, wherein the stent is formed from metal.

16. The stent of claim 15, wherein the metal is taken from the group of metals including stainless steel, titanium, nickel-titanium, cobalt-chromium, cobalt-chromium-vanadium, cobalt-chromium-tungsten, gold, silver, platinum, or platinum iridium.

17. The stent of claim 1, wherein the stent is coated with at least one layer of a drug.

18. The stent of claim 1, wherein the stent is coated with at least one layer of a therapeutic agent.

19. The stent of claim 1, wherein at least a portion of the stent is coated with at least one layer of a therapeutic agent.

20. The stent of claim 1, wherein at least a portion of the stent is coated with a primer material which adheres to the stent, the primer material being coated with at least one layer of a therapeutic agent or drug.

21. The stent of claim 1, wherein the central section peaks being adapted to appose and contact the opening to the side branch vessel and the first section peaks and the second section peaks being adapted to appose and contact the main branch vessel.

22. A stent for treating a bifurcated vessel having a main vessel and a side branch vessel, comprising:

a cylindrical body having a proximal end and a distal end;

the cylindrical body having a proximal section, a distance section, and a central section, wherein each of the sections is configured to be used with two balloons such that a first balloon extends through the proximal, distal and central sections, and a second balloon extends through the proximal and central sections; and

the central section having an expanded diameter greater than the expanded diameter of the proximal section and the distal section to thereby provide additional material to treat a bifuracated vessel, the central section being configured to flare radially outwardly into contact with an opening to the side branch vessel and into at least a portion of the side branch vessel.

23. The stent of claim 22, wherein the cylindrical body has a plurality of rings aligned along a common longitudinal axis.

24. The stent of claim 23, wherein each of the proximal section, distal section, and central section have at least one ring wherein each ring has a plurality of first peaks.

25. The stent of claim 24, wherein the rings of the proximal section have between four and twelve first peaks, the rings of the distal section have between four and twelve first peaks, and the rings of the central section have between five and fifteen first peaks.

26. The stent of claim 24, wherein the rings of the proximal section have seven first peaks, the rings of the distal section have six first peaks, and the rings of the central section have eight first peaks.

27. The stent of claim 24, wherein the number of first peaks in the ring(s) of the central section is greater than the number of first peaks in any of the rings in either the proximal section or the distal section.

28. The stent of claim 23, wherein the adjacent rings are connected by links.

29. The stent of claim 23, wherein the rings are connected by at least one link between adjacent rings.

30. The stent of claim 29, wherein at least some of the links have a straight segment.

31. The stent of claim 29, wherein at least some of the links have a curved segment.

32. The stent of claim 29, wherein at least some of the links have a straight segment and a curved segment.

33. The stent of claim 29, wherein at least some of the links have a non-linear segment.

34. The stent of claim 23, wherein each ring has at least one second peak.

35. The stent of claim 34, wherein at least some of the at least one second peaks is connected to a link.

36. The stent of claim 22, wherein the distal opening and the proximal opening are aligned along the stent longitudinal axis.

37. The stent of claim 36, wherein the central opening is radially offset relative to the alignment of the distal opening and the proximal opening.

38. The stent of claim 22, wherein the stent is formed from metal.

39. The stent of claim 38, wherein the metal is taken from the group of metals including stainless steel, titanium, nickel-titanium, cobalt-chromium, cobalt-chromium-vanadium, cobalt-chromium-tungsten, gold, silver, platinum, or platinum iridium.

40. The stent of claim 22, wherein the stent is coated with at least one layer of a drug.

41. The stent of claim 22, wherein the stent is coated with at least one layer of a therapeutic agent.

42. The stent of claim 22, wherein at least a portion of the stent is coated with at least one layer of a therapeutic agent.

43. The stent of claim 22, wherein at least a portion of the stent is coated with a primer material which adheres to the stent, the primer being coated with at least one layer of a therapeutic agent or drug.

44. A stent for treating a bifurcated vessel having a main vessel and a side branch vessel, comprising:

a. a cylindrical body having a plurality of rings aligned along a common longitudinal axis;

b. each ring having a delivered diameter and an implanted diameter and a plurality of first peaks configured to spread apart to permit the rings to expand radially outwardly or compress radially;

c. the cylindrical body having a proximal section, a distal section, and a central section, wherein each of the sections is configured to be used with two balloons such that a first balloon extends through the proximal, distal and central sections, and a second balloon extends through the proximal and central sections; and

d. the central section having at least one ring in which at least some of the plurality of first peaks have a plurality of corresponding nested peaks therein to thereby provide additional material to treat a bifurcated stent, the central section peaks being configured to flare radially outwardly into contact with an opening to the side branch vessel and into at least a portion of the side branch vessel.

45. The stent of claim 44, wherein the rings of the proximal section have between four and twelve first peaks, the rings of the distal section have between four and twelve first peaks, and the rings of the central section have between five and fifteen first peaks.

46. The stent of claim 44, wherein the rings of the proximal section have seven first peaks, the rings of the distal section have six first peaks, and the rings of the central section have eight first peaks.

47. The stent of claim 44, wherein the number of first peaks in the ring(s) of the central section is greater than the number of first peaks in any of the rings in either the proximal section or the distal section.

48. The stent of claim 44, wherein the central section has only one ring.

49. The stent of claim 48, wherein at least some of the first peaks of the ring have corresponding nested peaks therein.

50. The stent of claim 44, wherein the rings are connected by links.

51. The stent of claim 44, wherein the rings are connected by at least one link between adjacent rings.

52. The stent of claim 51, wherein at least some of the links have a straight segment.

53. The stent of claim 51, wherein at least some of the links have a curved segment.

54. The stent of claim 51, wherein at least some of the links have a straight segment and a curved segment.

55. The stent of claim 51, wherein at least some of the links have a non-linear segment.

56. The stent of claim 44, wherein the tubular body has a distal opening, a proximal opening, and a central opening.

57. The stent of claim 56, wherein at least some of the rings in the proximal, distal and central sections have at least one second peak.

58. The stent of claim 44, wherein the stent is formed from metal.

59. The stent of claim 58, wherein the metal is taken from the group of metals including stainless steel, titanium, nickel-titanium, cobalt-chromium, cobalt-chromium-vanadium, cobalt-chromium-tungsten, gold, silver, platinum, or platinum iridium.

60. The stent of claim 44, wherein the stent is coated with at least one layer of a drug.

61. The stent of claim 44, wherein the stent is coated with at least one layer of a therapeutic agent.

62. The stent of claim 44, wherein at least a portion of the stent is coated with at least one layer of a therapeutic agent.

63. The stent of claim 44, wherein at least a portion of the stent is coated with a primer material which adheres to the stent, the primer being coated with at least one layer of a therapeutic agent or drug.

64. A stent for treating a bifurcated vessel having a main vessel and a side branch vessel, comprising:

a cylindrical body having a proximal section, a distal section and a central section, wherein the proximal section, distal section, and the central section are configured to be used with two balloons such that a first balloon extends through the proximal, distal and central sections, and a second balloon extends through the proximal and central sections, each of the sections having a first delivery diameter and a second implanted diameter; and

the central section second diameter being greater than the second diameter of the proximal section and the distal section to thereby provide additional material to treat a bifurcated vessel.

65. The stent of claim 64, wherein the proximal section, distal section and central section are connected by links.

66. The stent of claim 65, wherein the sections are connected by at least one link between adjacent sections.

67. The stent of claim 66, wherein at least some of the links have a straight segment.

68. The stent of claim 66, wherein at least some of the links have a curved segment.

69. The stent of claim 66, wherein at least some of the links have a straight segment and a curved segment.

70. The stent of claim 66, wherein at least some of the links have a non-linear segment.

71. The stent of claim 64,wherein the cylindrical body is formed from a metal.

72. The stent of claim 64, wherein the stent is coated with at least one layer of a drug.

73. The stent of claim 64, wherein the stent is coated with at least one layer of a therapeutic agent.

74. The stent of claim 64, wherein at least a portion of the stent is coated with at least one layer of a therapeutic agent.

75. The stent of claim 64, wherein at least a portion of the stent is coated with a primer material which adheres to the stent, the primer material being coated with at least one layer of a therapeutic agent or drug.

76. A stent for treating a bifurcated vessel having a main vessel and a side branch vessel, comprising:

a cylindrical body having a first section and a second section, each section configured to be used with two balloons such that a first balloon extends through the first section and the second section, and a second balloon extends through the second section;

each section having a plurality of rings aligned along a common longitudinal axis and adjacent rings being interconnected by links, at least some of the links connecting one pair of adjacent rings being, circumferentially offset from the links connecting another pair of adjacent rings;

at least some of the rings positioned in the first section and the second section; and

the rings in the second section having a larger diameter than the rings in the first section, the second section rings being configured to flare radially outwardly into contact with an opening to the side branch vessel and at least a portion of the side branch vessel.

77. The stent of claim 76, wherein each of the rings has a plurality of first peaks configured to spread apart and to permit the rings to expand radially outwardly or to compress radially inwardly.

78. The stent of claim 77, wherein the first peaks are in the form of undulations.

79. The stent of claim 77, wherein the number of first peaks in the rings of the second section are greater than the number of first peaks in the rings of the first section.

80. The stent of claim 77, wherein adjacent rings are connected by at least one link.

81. The stent of claim 80, wherein at least some of the links have a straight segment.

82. The stent of claim 80, wherein at least some of the links have a non-linear segment.

83. The stent of claim 77, wherein at least a portion of the stent is coated with at least one layer of a therapeutic agent or drug.

84. The stent of claim 77, wherein at least a portion of the stent is coated with a primer material which adheres to the stent, the primer material being coated with at least one layer of a therapeutic agent or drug.

85. A stent for treating a bifurcated vessel having a main vessel and a side branch vessel, comprising:

an elongated cylindrical body, having a first section and a second section, wherein the first and second section are configured to be used with two balloons such that a first balloon extends through the first section and the second section, and a second balloon extends through the second section; and

the first section having a diameter that is less than a diameter of the second section, the second section being configured to flare radially outwardly into contact with an opening to the side branch vessel and at least a portion of the side branch vessel.

86. The stent of claim 85, wherein the first section and the second section have at least one ring.

87. The stent of claim 86, wherein each ring in the first section and the second section has a plurality of peaks configured to spread apart to permit the rings to expand radially outwardly or compress radially inwardly.

88. The stent of claim 87, wherein adjacent rings are connected by links.

89. The stent of claim 88, wherein at least some of the links have a straight segment.

90. The stent of claim 88, wherein at least some of the links have a non-linear segment.

91. The stent of claim 86, wherein the stent is formed from a metal.

92. The stent of claim 85, wherein the stent is coated with at least one layer of a drug or therapeutic agent.

93. The stent of claim 85, wherein at least a portion of the stent is coated with a primer material which adheres to the stent, the primer material being coated with at least one layer of a therapeutic agent or drug.

94. A stent for treating a bifurcated vessel having a main vessel and a side branch vessel, comprising:

an elongated cylindrical body having a proximal section, a distal section, and a central section, each of the sections configured to be used with two balloons such that a first balloon extends through the proximal, distal and central sections, and a second balloon extends through the proximal and central sections;

the proximal section and the central section having a diameter that is larger than a diameter of the distal section to thereby provide additional material to treat a bifurcated vessel; and

the central section having peaks configured to flare radially outwardly into contact with an opening to the side branch vessel and at least a portion of the side branch vessel.

95. A stent for treating a bifurcated vessel having a main vessel and a side branch vessel, comprising:

a cylindrical body having a proximal section, a distal section and a central section, wherein each of the sections are configured to be used with two balloons such that a first balloon extends through the proximal, distal and central sections, and a second balloon extends through the proximal and central sections;

each section having a plurality of rings aligned along a common longitudinal axis, at least some of the rings having a diameter greater than a diameter of the remaining rings; and

a central opening positioned on the stent and configured to be expandable for apposing an opening to the side branch vessel, the central section rings being configured to flare radially outwardly into contact with the opening to the side branch vessel and into at least a portion of the side branch vessel.

96. The stent of claim 95, wherein the stent has a proximal opening and a distal opening substantially aligned along the stent longitudinal axis.

97. The stent of claim 96, wherein the central opening is radially offset relative to the alignment of the distal opening and the proximal opening.

98. The stent of claim 95, wherein at least a portion of the stent is coated with a therapeutic agent or drug.

99. A central section of a stent for stenting the opening to a side branch vessel, comprising:

at least one ring having a plurality of undulations configured for both compressing radially inwardly to a first delivery diameter and expanding radially outwardly to a second implanted diameter; and

the central section configured so that upon expansion the section will oppose the opening to the side branch vessel.

100. The central section of claim 99, wherein a proximal section and a distal section are associated with the central section.

101. The central section of claim 100, wherein the proximal section and the distal section are axially aligned along a common longitudinal axis.

102. The central section of claim 101, wherein the central section is radially offset from the longitudinal axis of the proximal section and the distal section.

103. The central section of claim 102, wherein the proximal section, central section and distal section are connected by links.

104. The central section of claim 99, wherein at least a portion of the central section is coated with a therapeutic agent or drug.

105. A stent for treating a bifurcated vessel having a main vessel and a side branch vessel, comprising:

a cylindrical body having a proximal section, a distal section and a central section, wherein each of the sections is configured to be used with two balloons such that a first balloon extends through the proximal, distal and central sections, and a second balloon extends through the proximal and central sections;

wherein at least one of the sections includes, a ring forming a central opening, the ring having a first delivery diameter and a second implanted diameter; and

the central opening being adapted to flare radially outwardly into contact with the opening to the side branch vessel when the at least one ring is in the second implanted diameter configuration.

106. The central opening of claim 105, wherein a proximal section, a distal section and a central section are attached to form the central opening.

107. The central opening of claim 106, wherein the proximal section and the distal section have a plurality of rings along a common longitudinal axis.

108. The central opening of claim 107, wherein the at least one ring forming the central opening has a diameter that is larger than the diameter of the rings of the proximal section and the distal section.

109. The central opening of claim 108, wherein the rings are connected by links.

110. The central opening of claim 105, wherein the at least one ring is coated with a therapeutic agent or drug.

111. A stent for treating a bifurcated vessel having a main vessel and a side branch vessel, comprising:

a plurality of rings connected by links;

a central opening defined by at least one ring; and

a proximal opening and a distal opening being in approximate axial alignment and the central opening being radially offset from the proximal opening and the distal opening;

the proximal opening, the distal opening, and the central opening are configured to be used with two balloons such that a first balloon extends through the proximal and distal openings, and a second balloon extends through the proximal and central openings; and

the at least one ring of the central opening being configured to flare radially outwardly into contact with an opening to the side branch vessel and into at least a portion of the side branch vessel.

112. A stent for treating a bifurcated vessel having a main vessel and a side branch vessel, comprising:

an elongated cylindrical body having a proximal section, a distal section and a central section, wherein each of the sections is configured to be used with two balloons such that a first balloon extends through the proximal, distal and central sections, and a second balloon extends through the proximal and central sections;

the central section having a central lumen and defining a central longitudinal axis;

the proximal section and the distal section defining a lumen having a common longitudinal axis; and

wherein the central section central longitudinal axis is radially offset from the common longitudinal axis of the proximal section and the distal section, the central section being configured to flare radially outwardly into an opening of the side branch vessel and into at least a portion of the side branch vessel.