Apparatus and methods for treating hardened vascular lesions

• US 20040143287A1
• Filed: 07/30/2003
• Published: 07/22/2004
• Est. Priority Date: 01/21/2003
• Status: Active Grant

• Current Assignee: Spectranetics Corporation (Koninklijke Philips N.V.)
• Original Assignee: Angioscore Incorporated (Koninklijke Philips N.V.)
• Inventors: Feld, Tanhum, Konstantino, Eitan, Tzori, Nimrod
• Granted Patent: US 7,686,824 B2
• Time in Patent Office: Days
• 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: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A plaque scoring catheter comprises a catheter body having a balloon or other radially expansible shell at its distal end. A non-axial scoring structure is carried over the shell and scores a stenosed region in a blood vessel when the balloon is inflated therein. The non-axial scoring structure may be formed directly on the balloon or may alternatively be part of a cage structure which floats over the balloon. Exemplary configurations for the scoring structure include helical, serpentine, and irregular.

Claims

1. A scoring catheter comprising:

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

a radially expansible shell near the distal end of the catheter body; and

a non-axial scoring structure carried over the shell.

2. A catheter as in claim 1, wherein said scoring structure comprises at least one continuous scoring element having a length of at least 2 cm.

3. A catheter as in claim 1, wherein said scoring structure comprises a plurality of segments having lengths of 2 cm or less.

4. A catheter as in any of claims 1 to 3, wherein at least a portion of the scoring structure circumscribes the radially expansible shell structure.

5. A catheter as in claim 4, wherein at least a portion of said scoring structure is arranged helically over the shell.

6. A catheter as in claim 4, wherein at least a portion of said scoring structure is arranged in a serpentine pattern over the shell.

7. A catheter as in claim 4, wherein at least a portion of said scoring structure is arranged circumferentially over the shell.

8. A catheter as in claim 1, wherein the expansible shell has an expansible area and the scoring structure covers a percentage of the expansible area below 20%.

9. A catheter as in claim 8, wherein the percentage is in the range from 1% to 5%.

10. A catheter as in claim 1, wherein at least a portion of the scoring structure comprises a wire.

11. A catheter as in claim 1, wherein the scoring structure is secured to or embedded within an outer surface of the shell.

12. A catheter as in claim 1, wherein the scoring structure is incorporated in a cage structure which at least partly circumscribes the shell.

13. A catheter as in claim 12, wherein the cage structure is attached directly to the catheter body at at least one point.

14. A catheter as in claim 13, wherein the cage structure is not attached to the shell.

15. A catheter as in claim 14, wherein the cage structure is attached to the catheter body near one end of the shell and is free to slide axially at the other end of the shell.

16. A catheter as in claim 12, wherein the cage structure is elastic and arranged to radially close over the expansible shell when the shell is collapsed.

17. A catheter as in claim 15, wherein at least a portion of the cage is composed of a superelastic material.

18. A catheter as in claim 1, wherein the assembly of the shell and the scoring structure is sufficiently flexible to permit bending at a radius of 10 mm or below when advanced through the coronary vascular.

19. A catheter as in claim 1, wherein the non-axial scoring structure comprises one or more scoring elements, wherein less than 70% of the cumulative length of the scoring elements is aligned axially on the shell when expanded.

20. A catheter as in claim 19, wherein less than 50% of the cumulative length is aligned axially.

21. A catheter as in claim 20, wherein less than 25% of the length is aligned axially.

22. A catheter as in claim 1, wherein the non-axial scoring structure comprises one or more scoring elements, wherein the cumulative length of the scoring elements includes a non-axial component of at least 10 mm.

23. A catheter as in claim 22, wherein the non-axial component is at least 12 mm.

24. A catheter as in claim 23, wherein the non-axial component is at least 36 mm.

116. A catheter as in claim 1, wherein the scoring structure comprises a pair of axially spaced-apart attachment structures with at least one scoring element disposed therebetween.

117. A catheter as in claim 116 wherein at least one of the attachment structures is fixed to the catheter body on one side of the radially expansible shell.

118. A catheter as in claim 117, wherein only one of the attachment structures is fixed and the other is adapted to axially slide as the scoring element foreshortens as the shell is expanded.

119. A catheter as in claim 117, wherein both attachment structures are fixed to the catheter structure.

120. A catheter as in claim 119, where in at least one of the attachment structures includes an axially extensible component adapted to accommodate foreshortening of the scoring element as the shell is expanded.

121. A catheter as in claim 116, wherein the scoring element has a scoring edge over at least a portion of its length.

122. A catheter as in claim 121, wherein the scoring element is oriented radially outwardly as the shell is expanded.

123. A catheter as in claim 116, wherein the scoring element is substantially free of a scoring edge.

25. A scoring catheter comprising:

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

a radially expansible shell near the distal end of the catheter body; and

a scoring structure circumscribing the radially expansible shell.

26. A catheter as in claim 25, wherein said scoring structure comprises at least one continuous scoring element having a length of at least 2 cm.

27. A catheter as in claim 26, wherein said scoring structure comprises a plurality of segments each having a length of 2 cm or less.

28. A catheter as in any of claims 25 to 27, wherein at least a portion of the scoring structure is aligned non-axially over the shell.

29. A catheter as in claim 28, wherein at least a portion of said scoring structure is arranged helically over the shell.

30. A catheter as in claim 28, wherein at least a portion of said scoring structure is arranged in a serpentine pattern over the shell.

31. A catheter as in claim 28, wherein at least a portion of said scoring structure is arranged circumferentially over the shell.

32. A catheter as in claim 25, wherein the expansible shell has an expansible area and the scoring structure covers a percentage of the expansible area below 20%.

33. A catheter as in claim 32, wherein the percentage is in the range from 1% to 5%.

34. A catheter as in claim 25, wherein at least a portion of the scoring structure comprises a wire.

35. A catheter as in claim 25, wherein the scoring structure is secured to an outer surface of the shell.

36. A catheter as in claim 35, wherein the scoring structure is incorporated in a cage structure which circumscribes the shell.

37. A catheter as in claim 36, wherein the cage structure is attached directly to the catheter body at at least one point.

38. A catheter as in claim 37, wherein the cage structure is not attached to the shell.

39. A catheter as in claim 38, wherein the cage structure is elastic and arranged to radially close over the expansible shell when the shell is collapsed.

40. A catheter as in claim 36, wherein the cage structure is elastic and arranged to radially close over the expansible shell when the shell is collapsed.

41. A catheter as in claim 35, wherein at least a portion of the cage is composed of a superelastic material.

42. A catheter as in claim 25, wherein the assembly of the shell and the scoring structure is sufficiently flexible to permit bending at a radius of 10 mm or below when advanced through the coronary vascular.

43. A catheter as in claim 25, wherein the scoring structure comprises one or more scoring elements, wherein less than 70% of the cumulative length of the scoring elements is aligned axially on the shell when expanded.

44. A catheter as in claim 43, wherein less than 50% of the cumulative length is aligned axially.

45. A catheter as in claim 44, wherein less than 25% of the length is aligned axially.

46. A catheter as in claim 25, wherein the non-axial scoring structure comprises one or more scoring elements having a scoring edge, wherein the cumulative length of the scoring edge includes a non-axial component of at least 10 mm.

47. A catheter as in claim 46, wherein the non-axial component is at least 12 mm.

48. A catheter as in claim 47, wherein the non-axial component is at least 36 mm.

51. A catheter as in claim 34, wherein said scoring structure comprises a plurality of segments each having a length of 2 cm or less.

58. A catheter as in claim 44, wherein at least a portion of the scoring structure comprises a wire.

124. A catheter as in claim 25, wherein the scoring structure comprises a pair of axially spaced-apart attachment structures with at least one scoring element disposed therebetween.

125. A catheter as in claim 124, wherein at least one of the attachment structures is fixed to the catheter body on one side of the radially expansible shell.

126. A catheter as in claim 125, wherein only one of the attachment structures is fixed and the other is adapted to axially slide as the scoring element foreshortens as the shell is expanded.

127. A catheter as in claim 126, wherein both attachment structures are fixed to the catheter structure.

128. A catheter as in claim 127, wherein at least one of the attachment structures includes an axially extensible component adapted to accommodate foreshortening of the scoring element as the shell is expanded.

129. A catheter as in claim 124, wherein the scoring element has a scoring edge over at least a portion of its length.

131. A catheter as in claim 124 wherein the scoring element is substantially free of a scoring edge.

49. A scoring catheter comprising:

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

a radially expansible shell near the distal end of the catheter body; and

an elongated scoring structure carried over the shell, wherein the scoring structure and the shell form an assembly which when unexpanded is bendable to an angle of 90°

at a radius of 1 cm without kinking.

50. A catheter as in claim 49, wherein said scoring structure comprises at least one continuous scoring element having a length of at least 2 cm.

52. A catheter as in any of claims 49 to 51, wherein at least a portion of the scoring structure circumscribes the radially expansible shell structure.

53. A catheter as in claim 52, wherein at least a portion of said scoring structure is arranged helically over the shell.

54. A catheter as in claim 52, wherein at least a portion of said scoring structure is arranged in a serpentine pattern over the shell.

55. A catheter as in claim 52, wherein at least a portion of said scoring structure is arranged circumferentially over the shell.

56. A catheter as in claim 49, wherein the expansible shell has an expansible area and the scoring structure covers a percentage of the expansible area below 10%.

57. A catheter as in claim 56, wherein the percentage is in the range from 1% to 5%.

59. A catheter as in claim 49, wherein the scoring structure is secured to an outer surface of the shell.

60. A catheter as in claim 49, wherein the scoring structure is incorporated in a cage structure which circumscribes the shell.

61. A catheter as in claim 60, wherein the cage structure is attached directly to the catheter body at at least one point.

62. A catheter as in claim 61, wherein the cage structure is not attached to the shell.

63. A catheter as in claim 62, wherein the cage structure is attached to the catheter body near one end of the shell and is free to slide axially at the other end of the shell.

64. A catheter as in claim 60, wherein the cage structure is elastic and arranged to radially close over the expansible shell when the shell is collapsed.

65. A catheter as in claim 64, wherein at least a portion of the cage is composed of a superelastic material.

66. A catheter as in claim 49, wherein the scoring structure comprises one or more scoring elements, wherein less than 70% of the cumulative length of the scoring elements is aligned axially on the shell when expanded.

67. A catheter as in claim 66, wherein less than 50% of the cumulative length is aligned axially.

68. A catheter as in claim 67, wherein less than 25% of the length is aligned axially

69. A catheter as in claim 49, wherein the non-axial scoring structure comprises one or more scoring elements, wherein the cumulative length of the scoring elements includes a non-axial component of at least 10 mm.

70. A catheter as in claim 69, wherein the non-axial component is at least 12 mm.

71. A catheter as in claim 70, wherein the non-axial component is at least 36 mm.

73. A catheter as in claim 50, where the scoring elements have lengths in the range from 2% to 10% of the balloon length.

76. A catheter as in claim 50 or 51, wherein at least some of the scoring elements are arranged axially on the balloon.

132. A catheter as in claim 49, wherein the scoring structure comprises a pair of axially spaced-apart attachment structures with at least one scoring element disposed therebetween.

133. A catheter as in claim 132, wherein at least one of the attachment structures is fixed to the catheter body on one side of the radially expansible shell.

134. A catheter as in claim 133, wherein only one of the attachment structures is fixed and the other is adapted to axially slide as the scoring element foreshortens as the shell is expanded.

135. A catheter as in claim 133, wherein both attachment structures are fixed to the catheter structure.

136. A catheter as in claim 135, wherein at least one of the attachment structures includes an axially extensible component adapted to accommodate foreshortening of the scoring element as the shell is expanded.

137. A catheter as in claim 132, wherein the scoring element has a scoring edge over at least a portion of its length.

138. A catheter as in claim 137, wherein the scoring element is oriented radially outwardly as the shell is expanded.

139. A catheter as in claim 132 wherein the scoring element is substantially free of a scoring edge.

72. A scoring catheter comprising:

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

a radially expansible balloon near the distal end of the catheter body, said balloon having a length in the axial direction; and

a plurality of scoring elements distributed over the balloon, wherein each of the scoring elements have a length below 25% of the balloon length.

74. A catheter as in claim 72 or 73, wherein the scoring elements are distributed uniformly over the balloon.

75. A catheter as in claim 72 or 73, wherein at least some of the scoring elements are arranged non-axially on the balloon.

77. A scoring catheter comprising:

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

a radially expansible balloon near the distal end of the catheter body, said balloon having a proximal end, a distal end, and a plurality of lobes extending between said ends; and

at least one scoring element on at least one of the lobes arranged to score stenotic material as the balloon is inflated in a blood vessel.

78. A catheter as in claim 77, wherein the balloon has at least threes lobes.

79. A catheter as in claim 77 or 78, wherein the lobes are arranged helically.

80. A catheter as in claim 79, wherein each helical lobe has at least one scoring element disposed along a helical peak thereof.

81. A catheter as in claim 79, wherein the scoring elements are segmented.

82. A catheter as in claim 79, wherein the scoring elements are stretchable.

105. A method as in claim 81, wherein the scoring structure is entirely free from axial scoring segments.

110. A method as in claim 81, wherein the scoring structure is arranged in a helical pattern.

83. An expansible scoring cage adapted to be carried over a balloon of a balloon catheter, said cage comprising:

an assembly of one or more elongate elastic scoring elements arranged in a non-axial pattern, wherein said assembly is normally in a radially collapsed configuration and expansible over a balloon to a radially expanded configuration, wherein the assembly returns to its radially collapsed configuration when the balloon is deflated;

wherein the scoring elements are adapted to score hardened stenotic material when expanded by the balloon in a blood vessel lumen.

84. A scoring cage as in claim 83, wherein one or more elongate scoring elements disposed between a pair of collars, wherein said collars are mounted over the catheter with the balloon therebetween.

85. A scoring cage as in claim 84, wherein one of said collars is fixable to the catheter body and the other is free to slide axially over the catheter body.

86. A scoring cage as in any of claims 83 to 85, wherein at least a portion of the scoring element assembly is adapted to circumscribe the balloon.

87. A scoring cage as in claim 86, wherein the scoring elements are arranged helically over the balloon.

88. A scoring cage as in claim 86, wherein the scoring elements are arranged in a serpentine pattern over the balloon.

89. A scoring cage as in claim 83, wherein the scoring elements are arranged circumferentially over the balloon.

90. A scoring cage as in claim 83, wherein the expansible shell has an expanded area and the scoring elements covers a percentage of the expanded area below 10%.

91. A scoring cage as in claim 90, wherein the percentage is in the range from 1% to 5%.

92. A catheter as in claim 83, wherein at least a portion of the scoring structure comprises a wire.

93. A scoring cage as in claim 83, wherein the scoring elements are elastic and arranged to radially close over the balloon when the balloon is deflated.

94. A scoring cage as in claim 83, wherein at least a portion of the scoring element assembly is composed of a superelastic material.

95. An expansible scoring case as in claim 83, wherein the scoring cage is sufficiently flexible to permit bending at a radius of 10 mm or below when advanced through the coronary vasculature.

96. A cage as in claim 83, wherein the elastic scoring elements have scoring edges, wherein less than 70% of the cumulative length of the scoring edges is aligned axially when the elements are radially expanded.

97. A scoring cage as in claim 96, wherein less than 50% of the cumulative length is aligned axially.

98. A scoring cage as in claim 97, wherein less than 25% of the length is aligned axially.

99. An expansible scoring cage as in claim 83, wherein the elastic scoring elements, wherein the cumulative length of the scoring elements includes a non-axial component of at least 10 mm.

100. A scoring cage as in claim 99, wherein the non-axial component is at least 12 mm.

101. A scoring cage as in claim 100, wherein the non-axial component is at least 36 mm.

102. A method for dilatating a stenosed region in a blood vessel, said method comprising:

expanding a scoring structure within a stenosed region within the blood vessel, wherein said scoring structure includes one or more non-axial scoring segments arranged to impart a circumscribing score pattern about the inner wall of the blood vessel as the shell is expanded.

103. A method as in claim 102, wherein the stenosed region is characterized by the presence of calcified plaque, wherein the plaque is scored as the region is dilated.

104. A method as in claim 102, further comprising radially contracting the shell, wherein the scoring structure is not substantially moved in an axial direction while engaged against the stenosed region.

106. A method as in claim 102, wherein the scoring structure is continuous over the stenosed region.

107. A method as in claim 102, wherein the scoring structure is segmented over the stenosed region.

108. A method as in claim 102, wherein the scoring structure covers less than 10% of the wall area of the stenosed region.

109. A method as in claim 108, wherein the scoring structure covers less than 5% of the wall area of the stenosed region.

111. A method as in claim 102, wherein the scoring structure is arranged in a serpentine pattern.

112. A method as in claim 102, wherein radially expanding the shell comprises inflating a balloon which carries the scoring structure.

113. A method as in claim 112, further comprising deflating the balloon to contract the shell.

114. A method as in claim 113, wherein the scoring structure is at least partly elastic and exerts a radially co-pressure force to help close the balloon as the balloon is deflated.

115. A method as in claim 102, further comprising advancing an assembly of the radially expandable shell and the scoring structure through the coronary vasculature, wherein the assembly is adapted to permit bending at a radius of 10 mm or below as the assembly is advanced.

130. A catheter as in clam 129, wherein the scoring element is oriented radially outwardly as the shell is expanded.