Stiffened balloon catheter for dilatation and stenting

• US 6,942,680 B2
• Filed: 07/24/2001
• Issued: 09/13/2005
• Est. Priority Date: 07/24/2000
• Status: Expired due to Fees

• Current Assignee: Jeffrey Grayzel, Joseph Grayzel
• Original Assignee: Jeffrey Grayzel, Joseph Grayzel
• Inventors: Grayzel, Joseph, Grayzel, Jeffrey
• Primary Examiner(s): Bui, Vy Q.
• Application Number:
  US09/912,008
• Publication Number:
  US 20020010489A1
• Time in Patent Office: 1,512 Days
• Field of Search: 606191-195, 606/198, 606/159, 606/108, 604/500, 604/509, 604/96, 604/501, 604/502, 604/506, 604/507, 604 91- 95, 604 97-104, 604/264, 604/280, 623/1.11, 441/66, 600/3
• US Class Current: 606/194
• 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. A stiffened dilating balloon for use in the human body comprising:

an expandable balloon including a plurality of longitudinally discontinuous stiffening members disposed along a perimeter of said balloon;

wherein said balloon is made of a flexible material;

wherein the stiffening members are less flexible than said balloon;

wherein at least one of the stiffening members is directly connected to another one of the stiffening members by a filament; and

wherein each stiffening member affects a configuration of an area of said perimeter.

2. The balloon of claim 1 wherein the connected stiffening members are longitudinally aligned.

3. The balloon of claim 1 wherein the connected stiffening members are arranged at said perimeter in a staggered configuration.

4. The balloon of claim 3 wherein the connected stiffening members are arranged in a grid pattern.

5. The balloon of claim 1 wherein at least one of the connected stiffening members overlaps another one of the connected stiffening members.

6. The balloon of claim 5 wherein a portion of a first connected stiffening member extends above an outer surface of said balloon and extends over a portion of a second connected stiffening member.

7. The balloon of claim 6 wherein said first connected stiffening member is in contact with said second connected stiffening member.

8. The balloon of claim 6 wherein said first connected stiffening member is not in contact with said second connected stiffening member.

9. The balloon of claim 6 wherein said first connected stiffening member is connected to said second connected stiffening member by said filament.

10. The balloon of claim 6 wherein said first connected stiffening member is not connected to said second connected stiffening member.

11. The balloon of claim 1 wherein at least one of the connected stiffening members interdigitates with another one of the connected stiffening members.

12. The balloon of claim 1 wherein said filament is elastic.

13. The balloon of claim 1 wherein the connected stiffening members have a geometric shape.

14. The balloon of claim 1 wherein the connected stiffening members have a cross-section with a perimeter that includes a curvilinear portion.

15. The balloon of claim 1 wherein the connected stiffening members have a polygonal cross-section.

16. The balloon of claim 1 wherein the connected stiffening members include at least one raised surface.

17. The balloon of claim 6 wherein a raised surface is substantially smooth.

18. The balloon of claim 6 wherein a raised surface is substantially pointed.

19. The balloon of claim 6 wherein a raised surface is sufficiently sharp to pierce an occlusive material.

20. The balloon of claim 6 wherein a raised surface comprises a saw-tooth cutting element.

21. The balloon of claim 16 wherein a raised surface is sufficiently sharp to penetrate a vessel wall.

22. The balloon of claim 1 wherein the connected stiffening members are disposed along the perimeter of only a longitudinally central region of said balloon.

23. The balloon of claim 1 wherein at least one of the connected stiffening members comprises means for engaging an occlusive material in a lumen.

24. The balloon of claim 23 wherein said means for engaging comprises means for deforming said occlusive material.

25. The balloon of claim 23 wherein said means for engaging comprises a projection.

26. The balloon of claim 23 wherein said means for engaging comprises a raised surface.

27. The balloon of claim 1 wherein at least one of the connected stiffening members comprises means for piercing an occlusive material in a lumen.

28. The balloon of claim 1 wherein at least one of the connected stiffening members comprises means for removably coupling to a stent.

29. The balloon of claim 1 wherein at least one of the connected stiffening members comprises means for removably coupling to a stent-graft.

30. The balloon of claim 1 wherein at least one of the connected stiffening members is located within said balloon abutting an inner surface of said balloon.

31. The balloon of claim 1 wherein a portion of at least one of the connected stiffening members is radio-opaque.

32. The balloon of claim 1 wherein the connected stiffening members are disposed on a sheet of material adapted to be applied to said balloon.

33. The balloon of claim 1 wherein said filament is inelastic.

34. The balloon of claim 1 wherein said filament is radio-opaque.

35. The balloon of claim 1 wherein said filament is straight.

36. The balloon of claim 1 wherein said filament is nonlinear.

37. The balloon of claim 1 wherein said at least one stiffening member is connected to a plurality of the stiffening members by a corresponding plurality of filaments.

38. The balloon of claim 1 wherein the connected stiffening members are disposed along the perimeter of only an end region of said balloon.

39. The balloon of claim 1 wherein the connected stiffening members are disposed along the perimeter of a region of said balloon extending longitudinally no more than three-quarters of a length of said balloon.

40. The balloon of claim 1 wherein at least one of the connected stiffening members includes a projection.

41. The balloon of claim 40 wherein said projection is radio-opaque.

42. The balloon of claim 40 wherein said projection has a pointed end.

43. The balloon of claim 40 wherein said projection has a blunt end.

44. The balloon of claim 40 wherein said projection has an end that is sufficiently sharp to pierce an occlusive material.

45. The balloon of claim 40 wherein said projection has an end that is sufficiently sharp to penetrate a vessel wall.

46. The balloon of claim 40 wherein said projection comprises a saw tooth cutting element.

47. The balloon of claim 40 wherein said projection is adapted to removably couple to a device at said balloon.

48. The balloon of claim 47 wherein said device is a stent.

49. The balloon of claim 47 wherein said device is a stent-graft.

50. The balloon of claim 47 wherein said projection is adapted to interdigitate with said device.

51. The balloon of claim 40 wherein said projection is adapted to engage an occlusive material in a lumen.

52. The balloon of claim 40 wherein said projection is adapted to deform an occlusive material in a lumen.

53. The balloon of claim 1 wherein at least one of the connected stiffening members comprises means for removably coupling to a device.

54. The balloon of claim 1 wherein a plurality of the connected stiffening members each includes a projection.

55. The balloon of claim 54 wherein a projection is connected to another projection by a filament.

56. The balloon of claim 54 wherein a projection is connected to a plurality of projections by a corresponding plurality of filaments.

57. The balloon of claim 54 further comprising means for connecting a projection to another projection.

58. The balloon of claim 1 wherein at least one of the connected stiffening members has a geometric shape.

59. The balloon of claim 1 wherein at least one of the connected stiffening members has a cross-section with a perimeter that includes a curvilinear portion.

60. The balloon of claim 1 wherein at least a portion of one of the connected stiffening members has a polygonal cross-section.

61. The balloon of claim 1 wherein at least a portion of one of the connected stiffening members has a rectangular cross-section.

62. The balloon of claim 1 wherein at least a portion of one of the connected stiffening members has a triangular cross-section.

63. The balloon of claim 1 wherein at least one of the connected stiffening members is cylindrical.

64. The balloon of claim 1 wherein at least one of the connected stiffening members is longitudinally straight-walled and has a rectangular cross-section.

65. The balloon of claim 1 wherein the connected stiffening members are disposed along the perimeter of only a limited longitudinal region of said balloon.

66. The balloon of claim 65 wherein said limited longitudinal region has a length no greater than three-quarters of a length of a cylindrical section of said balloon.

67. The balloon of claim 1 wherein at least one of the connected stiffening members is located partly or entirely on an outer surface of a wall of said balloon.

68. The balloon of claim 1 wherein at least one of the connected stiffening members is located entirely within a wall of said balloon.

69. The balloon of claim 1 wherein at least one of the connected stiffening members is located partly or entirely on an inner surface of said balloon.

70. The balloon of claim 1 wherein at least one of the connected stiffening members extends into a wall of said balloon and protrudes from a surface of said balloon.

71. A stiffened dilating balloon catheter comprising:

an expandable balloon including a plurality of longitudinally discontinuous stiffening members disposed along a perimeter of said balloon;

wherein said balloon is made of a flexible material;

wherein the stiffening members are less flexible than said balloon;

wherein at least one of the stiffening members is directly connected to another one of the stiffening members by a filament; and

wherein each stiffening member affects a configuration of an area of said perimeter.

72. The balloon catheter of claim 71 wherein the connected stiffening members are longitudinally aligned.

73. The balloon catheter of claim 71 wherein the connected stiffening members are arranged at said perimeter in a staggered configuration.

74. The balloon catheter of claim 73 wherein the connected stiffening members are arranged in a grid pattern.

75. The balloon catheter of claim 71 wherein at least one of the connected stiffening members overlaps another one of the connected stiffening members.

76. The balloon catheter of claim 75 wherein a portion of a first connected stiffening member extends above an outer surface of said balloon and extends over a portion of a second connected stiffening member.

77. The balloon catheter of claim 76 wherein said first connected stiffening member is in contact with said second connected stiffening member.

78. The balloon catheter of claim 76 wherein said first connected stiffening member is not in contact with said second connected stiffening member.

79. The balloon catheter of claim 76 wherein said first connected stiffening member is connected to said second connected stiffening member by said filament.

80. The balloon catheter of claim 76 wherein said first connected stiffening member is not connected to said second connected stiffening member.

81. The balloon catheter of claim 71 wherein at least one of the connected stiffening members interdigitates with another one of the connected stiffening members.

82. The balloon catheter of claim 71 wherein said filament is elastic.

83. The balloon catheter of claim 71 wherein the connected stiffening members have a geometric shape.

84. The balloon catheter of claim 71 wherein the connected stiffening members have a cross-section with a perimeter that includes a curvilinear portion.

85. The balloon catheter of claim 71 wherein the connected stiffening members have a polygonal cross-section.

86. The balloon catheter of claim 71 wherein the connected stiffening members include at least one raised surface.

87. The balloon catheter of claim 86 wherein a raised surface is substantially smooth.

88. The balloon catheter of claim 86 wherein a raised surface is substantially pointed.

89. The balloon catheter of claim 86 wherein a raised surface is sufficiently sharp to pierce an occlusive material.

90. The balloon catheter of claim 86 wherein a raised surface comprises a saw-tooth cutting element.

91. The balloon catheter of claim 86 wherein a raised surface is sufficiently sharp to penetrate a vessel wall.

92. The balloon catheter of claim 71 wherein the connected stiffening members are disposed along the perimeter of only a longitudinally central region of said balloon.

93. The balloon catheter of claim 71 wherein at least one of the connected stiffening members comprises means for engaging an occlusive material in a lumen.

94. The balloon catheter of claim 93 wherein said means for engaging comprises means for deforming said occlusive material.

95. The balloon catheter of claim 93 wherein said means for engaging comprises a projection.

96. The balloon catheter of claim 93 wherein said means for engaging comprises a raised surface.

97. The balloon catheter of claim 71 wherein at least one of the connected stiffening members comprises means for piercing an occlusive material in a lumen.

98. The balloon catheter of claim 71 wherein at least one of the connected stiffening members comprises means for removably coupling to a stent.

99. The balloon catheter of claim 71 wherein at least one of the connected stiffening members comprises means for removably coupling to a stent-graft.

100. The balloon catheter of claim 71 wherein at least one of the connected stiffening members is located within said balloon abutting an inner surface of said balloon.

101. The balloon catheter of claim 71 wherein a portion of at least one of the connected stiffening members is radio-opaque.

102. The balloon catheter of claim 71 wherein the connected stiffening members are disposed on a sheet of material adapted to be applied to said balloon.

103. The balloon catheter of claim 71 wherein said filament is inelastic.

104. The balloon catheter of claim 71 wherein said filament is radio-opaque.

105. The balloon catheter of claim 71 wherein said filament is straight.

106. The balloon catheter of claim 71 wherein said filament is nonlinear.

107. The balloon catheter of claim 71 wherein said at least one stiffening member is connected to a plurality of the stiffening members by a corresponding plurality of filaments.

108. The balloon catheter of claim 71 wherein the connected stiffening members are disposed along the perimeter of only an end region of said balloon.

109. The balloon catheter of claim 71 wherein the connected stiffening members are disposed along the perimeter of a region of said balloon extending longitudinally no more than three-quarters of a length of said balloon.

110. The balloon catheter of claim 71 wherein at least one of the connected stiffening members includes a projection.

111. The balloon catheter of claim 110 wherein said projection is radio-opaque.

112. The balloon catheter of claim 110 wherein said projection has a pointed end.

113. The balloon catheter of claim 110 wherein said projection has a blunt end.

114. The balloon catheter of claim 110 wherein said projection has an end that is sufficiently sharp to pierce an occlusive material.

115. The balloon catheter of claim 110 wherein said projection has an end that is sufficiently sharp to penetrate a vessel wall.

116. The balloon catheter of claim 110 wherein said projection comprises a saw tooth cutting element.

117. The balloon catheter of claim 110 wherein said projection is adapted to removably couple to a device at said balloon.

118. The balloon catheter of claim 117 wherein said device is a stent.

119. The balloon catheter of claim 117 wherein said device is a stent-graft.

120. The balloon catheter of claim 117 wherein said projection is adapted to interdigitate with said device.

121. The balloon catheter of claim 110 wherein said projection is adapted to engage an occlusive material in a lumen.

122. The balloon catheter of claim 110 wherein said projection is adapted to deform an occlusive material in a lumen.

123. The balloon catheter of claim 71 wherein at least one of the connected stiffening members comprises means for removably coupling to a device.

124. The balloon catheter of claim 71 wherein a plurality of the connected stiffening members each includes a projection.

125. The balloon catheter of claim 124 wherein a projection is connected to another projection by a filament.

126. The balloon catheter of claim 124 wherein a projection is connected to a plurality of projections by a corresponding plurality of filaments.

127. The balloon catheter of claim 124 further comprising means for connecting a projection to another projection.

128. The balloon catheter of claim 71 wherein at least one of the connected stiffening members has a geometric shape.

129. The balloon catheter of claim 71 wherein at least one of the connected stiffening members has a cross-section with a perimeter that includes a curvilinear portion.

130. The balloon catheter of claim 71 wherein at least a portion of one of the connected stiffening members has a polygonal cross-section.

131. The balloon catheter of claim 71 wherein at least a portion of one of the connected stiffening members has a rectangular cross-section.

132. The balloon catheter of claim 71 wherein at least a portion of one of the connected stiffening members has a triangular cross-section.

133. The balloon catheter of claim 71 wherein at least one of the connected stiffening members is cylindrical.

134. The balloon catheter of claim 71 wherein at least one of the connected stiffening members is longitudinally straight-walled and has a rectangular cross-section.

135. The balloon catheter of claim 71 wherein the connected stiffening members are disposed along the perimeter of only a limited longitudinal region of said balloon.

136. The balloon catheter of claim 135 wherein said limited longitudinal region has a length no greater than three-quarters of a length of a cylindrical section of said balloon.

137. The balloon catheter of claim 71 wherein at least one of the connected stiffening members is located partly or entirely on an outer surface of a wall of said balloon.

138. The balloon catheter of claim 71 wherein at least one of the connected stiffening members is located entirely within a wall of said balloon.

139. The balloon catheter of claim 71 wherein at least one of the connected stiffening members is located partly or entirely on an inner surface of said balloon.

140. The balloon catheter of claim 71 wherein at least one of the connected stiffening members extends into a wall of said balloon and protrudes from a surface of said balloon.

141. A stiffened dilating balloon for use in the human body comprising:

an expandable balloon including a plurality of longitudinally discontinuous stiffening members disposed along a perimeter of said balloon; and

filament means for directly connecting at least one of the stiffening members to another one of the stiffening members;

wherein said balloon is made of a flexible material;

wherein the stiffening members are less flexible than said balloon; and

wherein each stiffening member affects a configuration of an area of said perimeter.

142. A stiffened dilating balloon catheter comprising:

an expandable balloon including a plurality of longitudinally discontinuous stiffening members disposed along a perimeter of said balloon; and

filament means for directly connecting at least one of the stiffening members to another one of the stiffening members;

wherein said balloon is made of a flexible material;

wherein the stiffening members are less flexible than said balloon; and

wherein each stiffening member affects a configuration of an area of said perimeter.

143. A method of dilating a portion of a lumen in a human body comprising the steps of:

introducing into said human body an expandable balloon including a plurality of longitudinally discontinuous stiffening members disposed along a perimeter of said balloon;

wherein said balloon is made of a flexible material;

wherein the stiffening members are less said balloon;

wherein at least one of the stiffening members is directly connected to another one of the stiffening members by a filament; and

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

positioning said expandable balloon at said portion; and

expanding said expandable balloon to cause the connected stiffening members to exert a first radial force against said portion;

wherein said filament prevents a distance between the connected stiffening members from exceeding a maximum distance; and

wherein said first radial force is greater than a radial force directly applied by an outer surface of said balloon against said portion.

144. The method of claim 143 wherein the step of positioning said expandable balloon includes the step of traversing a tortuous pathway in said human body.

145. The method of claim 143 wherein said portion comprises a stenosis.

146. A method of dilating a device in a lumen in a human body comprising the steps of:

introducing into said human body an expandable balloon including a plurality of longitudinally discontinuous stiffening members disposed along a perimeter of said balloon;

wherein said balloon is made of a flexible material;

wherein the stiffening members are less flexible than said balloon;

wherein at least one of the stiffening members is connected to another one of the stiffening members by a filament; and

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

positioning said expandable balloon at said device; and

expanding said expandable balloon to cause the connected stiffening members to exert a first radial force against said device;

wherein said filament prevents a distance between the connected stiffening members from exceeding a maximum distance; and

wherein said first radial force is greater than a radial force directly applied by an outer surface of said balloon against said device.

147. The method of claim 146 wherein the step of positioning said expandable balloon includes the step of traversing a tortuous pathway in said human body.

148. The method of claim 146 wherein said device is a stent.

149. The method of claim 146 wherein said device is a stent-graft.