Stiffened balloon catheter for dilatation and stenting

• US 20050102020A1
• Filed: 12/21/2004
• Published: 05/12/2005
• Est. Priority Date: 07/24/2000
• Status: Active Grant

• Current Assignee: Jeffrey Grayzel, Joseph Grayzel
• Original Assignee: Jeffrey Grayzel, Joseph Grayzel
• Inventors: Grayzel, Joseph, Grayzel, Jeffrey
• Granted Patent: US 7,883,537 B2
• Time in Patent Office: Days
• US Class Current: 623/1.110
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 2017/22061 for spreading elements apart
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• 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: A61M 2025/1079 having radio-opaque markers in the region of the balloon
• CPC Class Codes: A61M 2025/1084 having features for increasing the shape stability, the reproducibility or for limiting expansion, e.g. containments, wrapped around fibres, yarns or strands
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 2025/109 having balloons for removing solid matters, e.g. by grasping or scraping plaque, thrombus or other matters that obstruct the flow
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

The present invention pertains to a stiffened balloon which can be used in angioplasty, endovascular, and valvuloplasty procedures or as a delivery balloon to deliver a stent or a stent-graft. Longitudinally discontinuous stiffening members connected to the expandable balloon stiffen the balloon but allow it to be navigated through curved passages. Projections on the stiffening members may engage, incise, crush, fracture, or pierce occlusions or retain a stent or stent-graft. Radio-opaque portions may be referenced to determine orientation. Longitudinally continuous stiffening members bearing projections and connected to the balloon perform in a similar manner.

Claims

1-45. -45. (canceled)

46. A method of reconfiguring a portion of an expandable device deployed at a lumen comprising the steps of:

introducing into the lumen a stiffened balloon bearing a longitudinal stiffener at a first location on the balloon;

aligning said longitudinal stiffener with the portion of the expandable device; and

expanding said balloon to cause said stiffener to exert a first radial force against the portion of the expandable device to reconfigure the portion;

wherein said first radial force is greater than a radial force applied by said balloon at any other location on the balloon.

47. The method of claim 46 wherein said step of aligning comprises the steps of:

determining an orientation of said longitudinal stiffener with reference to a radio-opaque portion of the stiffener; and

modifying the orientation of said longitudinal stiffener to align with the portion of the expandable device.

48. The method of claim 47 wherein said step of determining an orientation comprises the step of determining a first rotational orientation of said longitudinal stiffener with reference to said radio-opaque portion.

49. The method of claim 48 wherein said expandable device is a stent.

50. The method of claim 48 wherein said expandable device is a stent-graft.

51. The method of claim 48 wherein said step of modifying the orientation of said longitudinal stiffener comprises the step of rotating the balloon around a longitudinal axis of the balloon to position said longitudinal stiffener at a second rotational orientation within the lumen.

52. The method of claim 51 wherein said step of aligning further comprises the step of determining said second rotational orientation with reference to said radio-opaque portion.

53. The method of claim 47 wherein said step of modifying the orientation of said longitudinal stiffener comprises the step of translating the balloon longitudinally within the lumen.

54. The method of claim 47 wherein said step of determining an orientation comprises the step of determining a longitudinal orientation of said longitudinal stiffener with reference to said radio-opaque portion.

55. The method of claim 54 wherein said step of modifying the orientation further comprises the step of translating said balloon longitudinally to position said stiffener at a second longitudinal orientation and to position said radio-opaque portion at another position.

56. The method of claim 55 wherein said step of modifying the orientation further comprises the step of determining said second longitudinal orientation with reference to said radio-opaque portion.

57. The method of claim 47 wherein said longitudinal stiffener is coextensive with a length of a cylindrical section of the balloon.

58. The method of claim 47 wherein said longitudinal stiffener is shorter than a length of a cylindrical section of the balloon.

59. A method of configuring an expandable device located in an anatomical lumen comprising the steps of:

introducing into said anatomical lumen a balloon having a stiffener attached at a perimeter of said balloon;

orienting said stiffener with said expandable device; and

expanding said balloon to cause said stiffener to exert a first radial force against said expandable device to configure said device.

60. The method of claim 59 wherein said step of orienting comprises the step of determining a first rotational orientation of said stiffener by viewing a radio-opaque portion of said stiffener located at a first position.

61. The method of claim 60 wherein said step of orienting further comprises the step of rotating said balloon around a longitudinal axis of said balloon to position said stiffener at a second rotational orientation and to position said radio-opaque portion at a second position.

62. The method of claim 61 wherein said step of orienting further comprises the step of determining said second rotational orientation by viewing said radio-opaque portion located at said second position.

63. The method of claim 62 wherein said expandable device is a stent.

64. The method of claim 62 wherein said expandable device is a stent-graft.

65. The method of claim 59 wherein said step of expanding said balloon comprises the step of expanding said balloon to cause said stiffener to expand said device.

66. The method of claim 59 wherein said step of orienting comprises the step of determining a first longitudinal orientation of said stiffener by viewing a radio-opaque portion of said stiffener located at a first position.

67. The method of claim 66 wherein said step of orienting further comprises the step of translating said balloon longitudinally to position said stiffener at a second longitudinal orientation and to position said radio-opaque portion at a second position.

68. The method of claim 67 wherein said step of orienting further comprises the step of determining said second longitudinal orientation by viewing said radio-opaque portion located at said second position.

69. A method of delivering an expandable device in an anatomical lumen comprising the steps of:

introducing into said anatomical lumen a balloon having a stiffener attached at a perimeter of said balloon and carrying an expandable device; and

expanding said balloon to cause said stiffener to exert a first radial force against said expandable device to expand said device.

70. The method of claim 69 further comprising the steps of:

deflating said balloon to reduce said first radial force;

rotating said balloon around a longitudinal axis of said balloon to orient said stiffener with a portion of said device that is not completely expanded; and

expanding said balloon to cause said stiffener to exert a second radial force against said portion to expand said device.

71. The method of claim 69 further comprising the steps of:

determining a first rotational orientation of said stiffener by viewing a radio-opaque portion of said stiffener located at a first position;

rotating said balloon around a longitudinal axis of said balloon to reposition said stiffener;

determining a second rotational orientation of said stiffener by viewing said radio-opaque portion located at a second position; and

expanding said balloon to cause said stiffener to exert a second radial force against said device to further expand said device.

72. The method of claim 71 wherein said step of rotating comprises the step of deflating said balloon to reduce said first radial force.

73. The method of claim 69 further comprising the steps of:

deflating said balloon to reduce said first radial force;

translating said balloon longitudinally to orient said stiffener with a portion of said device that is not completely expanded; and

expanding said balloon to cause said stiffener to exert a second radial force against said portion to expand said device.

74. The method of claim 69 further comprising the steps of:

determining a first longitudinal orientation of said stiffener by viewing a radio-opaque portion of said stiffener located at a first position;

translating said balloon longitudinally to reposition said stiffener;

determining a second longitudinal orientation of said stiffener by viewing said radio-opaque portion located at a second position; and

expanding said balloon to cause said stiffener to exert a second radial force against said device to further expand said device.

75. The method of claim 74 wherein said step of translating comprises the step of deflating said balloon to reduce said first radial force.

76. A method of dilating an anatomical lumen comprising the steps of:

introducing into said anatomical lumen a balloon having a stiffener attached at a perimeter of said balloon, wherein said stiffener includes a radio-opaque portion;

determining an orientation of said stiffener by viewing said radio-opaque portion located at a first position;

orienting said stiffener within said anatomical lumen; and

expanding said balloon to cause said stiffener to exert a first radial force against said anatomical lumen to dilate said anatomical lumen.

77. The method of claim 76 wherein said step of determining further comprises the step of determining a first rotational orientation of said stiffener by viewing said radio-opaque portion located at said first position.

78. The method of claim 77 wherein said step of orienting further comprises the step of rotating said balloon around a longitudinal axis of said balloon to position said stiffener at a second rotational orientation and to position said radio-opaque portion at a second position.

79. The method of claim 78 wherein said step of orienting further comprises the step of determining said second rotational orientation by viewing said radio-opaque portion located at said second position.

80. The method of claim 76 wherein said step of orienting further comprises the step of determining a first longitudinal orientation of said stiffener by viewing said radio-opaque portion located at said first position.

81. The method of claim 80 wherein said step of orienting further comprises the step of translating said balloon longitudinally to position said stiffener at a second longitudinal orientation and to position said radio-opaque portion at a second position.

82. The method of claim 81 wherein said step of orienting further comprises the step of determining said second longitudinal orientation by viewing said radio-opaque portion located at said second position.

83. A method of treating a stenosis in an anatomical lumen comprising the steps of:

introducing into said anatomical lumen a balloon having a stiffener attached at a perimeter of said balloon, wherein said stiffener has a radio-opaque portion and includes a projection;

determining an orientation of said projection by viewing said radio-opaque portion located at a first position;

orienting said projection with said stenosis; and

expanding said balloon to cause said projection to exert a first radial force against said stenosis.

84. The method of claim 83 wherein said step of determining further comprises the step of determining a first rotational orientation of said projection by viewing said radio-opaque portion located at said first position.

85. The method of claim 84 wherein said step of orienting further comprises the step of rotating said balloon around a longitudinal axis of said balloon to position said projection at a second rotational orientation and to position said radio-opaque portion at a second position.

86. The method of claim 85 wherein said step of orienting further comprises the step of determining said second rotational orientation by viewing said radio-opaque portion located at said second position.

87. The method of claim 83 wherein said step of orienting further comprises the step of determining a first longitudinal orientation of said projection by viewing said radio-opaque portion located at said first position.

88. The method of claim 87 wherein said step of orienting further comprises the step of translating said balloon longitudinally to position said projection at a second longitudinal orientation and to position said radio-opaque portion at a second position.

89. The method of claim 88 wherein said step of orienting further comprises the step of determining said second longitudinal orientation by viewing said radio-opaque portion located at said second position.

90. A stiffened balloon for use within an anatomic structure, said stiffened balloon comprising:

an expandable balloon; and

a stiffening member attached at a perimeter of said balloon;

wherein said balloon is made of a flexible material;

wherein said stiffening member is less flexible than said balloon;

wherein said stiffening member affects a configuration of an area of said perimeter; and

wherein at least a portion of said stiffening member is sufficiently radio-opaque to permit a precise determination of an orientation of said balloon within an anatomical structure.

91. The balloon of claim 90 wherein said portion has a radio-opacity substantially equivalent to a radio-opacity of a marker band.

92. The balloon of claim 90 wherein said portion comprises an external surface of said stiffening member.

93. The balloon of claim 90 wherein said portion comprises both ends of said stiffening member.

94. The balloon of claim 90 wherein said portion comprises an end of said stiffening member.

95. The balloon of claim 90 wherein said portion comprises a central portion of said stiffening member.

96. The balloon of claim 90 wherein said portion comprises the entirety of said stiffening member.

97. The balloon of claim 90 wherein said stiffening member is coextensive with a length of a cylindrical section of said balloon.

98. The balloon of claim 90 wherein said stiffening member is longitudinally oriented with respect to said balloon and said stiffening member is shorter than a length of a cylindrical section of said balloon.

99. The balloon of claim 98 wherein said stiffening member is located at a proximal end of said balloon.

100. The balloon of claim 98 wherein said stiffening member is located at a distal end of said balloon.

101. The balloon of claim 90 wherein said stiffening member includes a projection.

102. The balloon of claim 101 wherein said projection is sufficiently radio-opaque to permit a precise determination of an orientation of said balloon within an anatomical structure.

103. The balloon of claim 102 wherein said portion comprises said projection.

104. The balloon of claim 103 wherein said projection has a radio-opacity substantially equivalent to a radio-opacity of a marker band.