Abrasive drive shaft device for rotational atherectomy

• US 5,314,438 A
• Filed: 02/02/1993
• Issued: 05/24/1994
• Est. Priority Date: 12/17/1992
• Status: Expired due to Term

• Current Assignee: Cardiovascular Systems Incorporated (Boston Scientific Corporation)
• Original Assignee: Shturman Cardiology Systems, Inc.
• Inventors: Shturman, Leonid
• Primary Examiner(s): Pellegrino, Stephen C.
• Assistant Examiner(s): LEWIS, WILLIAM W
• Application Number:
  US08/012,444
• Time in Patent Office: 476 Days
• Field of Search: 606/159, 606/170, 606/171, 606/180, 604/22, 604/96
• US Class Current: 606/159
• CPC Class Codes: A61B 17/320758 with a rotating cutting instrument, e.g. motor driven A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002
• CPC Class Codes: A61B 2017/00553 using a turbine
• CPC Class Codes: A61B 2017/00853 low friction, hydrophobic and corrosion-resistant fluorocarbon resin coating (ptf, ptfe, polytetrafluoroethylene)
• CPC Class Codes: A61B 2017/00924 for ultrasonic waves
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2017/320004 abrasive
• CPC Class Codes: A61B 2017/320733 with a flexible cutting or scraping element, e.g. with a whip-like distal filament member
• CPC Class Codes: A61B 2090/3782 transmitter or receiver in catheter or minimal invasive instrument
• CPC Class Codes: A61F 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61M 25/01 Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence
• CPC Class Codes: A61M 25/09 Guide wires

Abstract

An abrasive drive shaft atherectomy device for removing stenotic tissue from an artery. The device includes a flexible, elongated drive shaft having a central lumen for receipt of a guide wire therein and around which the drive shaft may be rotated. The drive shaft is made from one or more helically wound wires. Wire turns of the proximal segment of the drive shaft have a generally constant diameter. Wire turns of a segment of the drive shaft near its distal end have an enlarged diameter. At least part of the enlarged diameter segment includes an external coating of an abrasive material to define an abrasive segment of the drive shaft which, when rotated at high speeds, is usable to remove stenotic tissue from an artery. In a preferred embodiment, the device includes a bushing disposed in the enlarged diameter segment for supporting the enlarged diameter turns of the drive shaft. A gap may be provided in the turns of the drive shaft to permit imaging therethrough by an ultrasound imaging device disposed in the central lumen of the drive shaft. Preferably the drive shaft is made from inner and outer coaxial wire layers helically wound in opposite directions so that the outer layer tends to radially contract and the inner layer tends to radially expand when the drive shaft is rotated in a predetermined direction. In one such embodiment, a toroidal collar is positioned between the inner and outer layers of the enlarged diameter abrasive segment of the drive shaft.

Claims

1. An abrasive drive shaft atherectomy device comprising a flexible, elongated drive shaft having a central lumen for receipt of a guide wire therein around which the drive shaft may be rotated, the drive shaft being comprised of at least one helically wound wire and having proximal, intermediate and distal segments, wire turns of the proximal segment of the drive shaft having a generally constant diameter, turns of the intermediate segment of the drive shaft having a diameter that progressively increases distally through a proximal portion of such intermediate segment and having a diameter that progressively decreases distally through a distal portion of such intermediate segment, thereby defining an enlarged diameter segment of the drive shaft, at least part of the enlarged diameter intermediate segment including an external coating of an abrasive material to define an abrasive segment of the drive shaft, the intermediate segment of the drive shaft including a gap between adjacent wire turns to define a sonolucent window in the intermediate segment.

2. The abrasive drive shaft atherectomy device of claim 1 wherein the wire turns of the drive shaft in the distal portion of the intermediate segment progressively decrease distally in diameter to a diameter not larger than the diameter of the wire turns of the proximal segment of the drive shaft.

3. The abrasive drive shaft atherectomy device of claim 1 wherein the wire turns of the drive shaft'"'"'s intermediate segment have a first pitch, at least one wire turn of the intermediate segment having a second, larger pitch to form the gap defining the sonolucent window in the intermediate segment.

4. The abrasive drive shaft atherectomy device of claim 1 wherein the gap is formed by a change in the pitch of the wire turns of the helically wound wire drive shaft.

5. The abrasive drive shaft atherectomy device of claim 1 wherein the gap in the intermediate segment of the drive shaft is located generally between the proximal and distal portions of the intermediate segment.

6. The abrasive drive shaft atherectomy device of claim 1 further comprising an intravascular ultrasonic imaging probe carrying ultrasonic imaging means for imaging tissue of interest, the probe being advancable into the central lumen of the drive shaft to a position acoustically aligning the ultrasonic imaging means with the sonolucent window in the intermediate segment of the drive shaft, permitting acoustic signals generated by the ultrasonic imaging means to propagate through the sonolucent window.

7. The abrasive drive shaft atherectomy device of claim 6 wherein the ultrasonic imaging means includes an array of ultrasonic transducer elements.

8. The abrasive drive shaft atherectomy device of claim 6 wherein the abrasive drive shaft is rotatable with respect to the intravascular ultrasonic imaging probe.

9. The abrasive drive shaft atherectomy device of claim 6 wherein the ultrasonic imaging means is secured to the drive shaft for rotation together with the drive shaft.

10. The abrasive drive shaft atherectomy device of claim 6 wherein the ultrasonic imaging means comprises an ultrasonic transducer element and an acoustic reflector.

11. The abrasive drive shaft atherectomy device of claim 10 wherein the acoustic reflector is rotatable with respect to the ultrasonic transducer element.

12. The abrasive drive shaft atherectomy device of claim 10 wherein the acoustic reflector and the ultrasonic transducer element are rotatable together as a unit.

13. The abrasive drive shaft atherectomy device of claim 6 wherein the intravascular ultrasonic imaging probe comprises an intravascular ultrasonic imaging catheter.

14. The abrasive drive shaft atherectomy device of claim 6 wherein the intravascular ultrasonic imaging probe comprises an ultrasonic imaging guide wire.

15. The abrasive drive shaft atherectomy device of claim 1 wherein the intermediate segment of the drive shaft includes a gap between adjacent wire turns to define a window in the intermediate segment, the abrasive shaft atherectomy device further including imaging means, advancable into the central lumen of the drive shaft to a position aligning said imaging means with the window in the intermediate segment of the drive shaft, for imaging tissue surrounding the intermediate segment of the drive shaft.

16. The abrasive drive shaft atherectomy device of claim 1 further comprising a bushing disposed within the intermediate segment of the drive shaft, the bushing having an outer surface engaging and supporting the wire turns of at least a portion of the intermediate segment, and having an inner longitudinal bore therethrough, the bore being generally coaxial with the drive shaft lumen.

17. The abrasive drive shaft atherectomy device of claim 16 wherein the diameter of the bushing bore is sized to receive the guide wire therein.

18. The abrasive drive shaft atherectomy device of claim 16 wherein the bushing is made of a flexible material.

19. The abrasive drive shaft atherectomy device of claim 16 wherein the bushing is made of a sonolucent material.

20. The abrasive drive shaft atherectomy device of claim 19 wherein the sonolucent material is silicone.

21. The abrasive drive shaft atherectomy device of claim 16 wherein the bushing is made of a low friction material.

22. The abrasive drive shaft atherectomy device of claim 21 wherein the low friction material is polytetrafluoroethylene.

23. The abrasive drive shaft atherectomy device of claim 16 wherein the inner surface of the bushing bore is made of a low friction material.

24. The abrasive drive shaft atherectomy device of claim 1 further comprising a flexible, low friction sheath covering at least that portion of the drive shaft immediately proximal to the intermediate segment of the drive shaft.

25. The abrasive drive shaft atherectomy device of claim 24 wherein the sheath is made of polytetrafluoroethylene.

26. The abrasive drive shaft atherectomy device of claim 24 further comprising a low friction sheath covering the distal segment of the drive shaft.

27. The abrasive drive shaft atherectomy device of claim 1 further comprising a flexible, low friction coating covering at least that portion of the drive shaft immediately proximal to the intermediate segment of the drive shaft.

28. The abrasive drive shaft atherectomy device of claim 27 wherein the coating is made of polytetrafluoroethylene.

29. The abrasive drive shaft atherectomy device of claim 1 wherein the drive shaft is made from wire substantially completely coated with polytetrafluoroethylene.

30. The abrasive drive shaft atherectomy device of claim 1 wherein the abrasive material comprises a plurality of abrasive particles which are secured directly to the wire turns of the drive shaft by a bonding material.

31. The abrasive drive shaft atherectomy device of claim 1 wherein the abrasive material comprises a plurality of abrasive particles which are secured directly to the drive shaft by a bonding material.

32. The abrasive drive shaft atherectomy device of claim 30 wherein the bonding material is applied to adjacent turns of the helically wound wire to secure the abrasive material to such turns and to secure at least some of such adjacent turns to one another.

33. The abrasive drive shaft atherectomy device of claim 30 wherein the bonding material is applied to adjacent turns of the helically wound wire to secure the abrasive material to such turns without securing any of such adjacent turns to one another.

34. The abrasive drive shaft atherectomy device of claim 31 wherein the abrasive particles are at least partially embedded in the bonding material, the thickness of the bonding material between substantially all of the abrasive particles and the drive shaft being not more than about 15 μ

m.

35. The abrasive drive shaft atherectomy device of claim 31 wherein the abrasive particles are at least partially embedded in the bonding material, the thickness of the bonding material between substantially all of the abrasive particles and the drive shaft being not more than about 5 μ

m.

36. The abrasive drive shaft atherectomy device of claim 1 wherein the abrasive material comprises diamond chips having a largest dimension of substantially 30 μ

m or less.

37. The abrasive drive shaft atherectomy device of claim 1 wherein the abrasive material comprises diamond chips having a largest dimension of substantially 25 μ

m or less.

38. The abrasive drive shaft atherectomy device of claim 1 wherein the coating of abrasive material is not thicker than about 45 μ

m.

39. The abrasive drive shaft atherectomy device of claim 1 wherein the coating of abrasive material is not thicker than about 35 μ

m.

40. The abrasive drive shaft atherectomy device of claim 1 wherein the maximum diameter of the abrasive segment, including the thickness of the abrasive coating, is not more than about 90 μ

m larger than the maximum outer diameter of the wire turns of the abrasive segment of the drive shaft.

41. The abrasive drive shaft atherectomy device of claim 1 wherein the maximum diameter of the abrasive segment, including the thickness of the abrasive coating, is not more than about 70 μ

m larger than the maximum outer diameter of the wire turns of the abrasive segment of the drive shaft.

42. The abrasive drive shaft atherectomy device of claim 1 wherein the coating of abrasive material is of a generally uniform thickness throughout the length of the abrasive segment.

43. The abrasive drive shaft atherectomy device of claim 1 wherein the drive shaft comprises a plurality of helically wound wires.

44. The abrasive drive shaft atherectomy device of claim 1 wherein the drive shaft is comprised of inner and outer co-axial wire layers helically wound in opposite directions so that the outer layer tends to radially contract and the inner layer tends to radially expand when the drive shaft is rotated in a predetermined direction.

45. The abrasive drive shaft atherectomy device of claim 44 wherein the outer wire layer extends along substantially the entire proximal segment of the drive shaft and terminates just proximal to the intermediate segment of the drive shaft.

46. The abrasive drive shaft atherectomy device of claim 44 wherein the outer wire layer extends along substantially all of the proximal and intermediate segments, and at least partially along the distal segment of the drive shaft.

47. An abrasive drive shaft atherectomy device comprising a flexible, elongated drive shaft having a central lumen for receipt of a guide wire therein around which the drive shaft may be rotated, the drive shaft being comprised of at least one helically wound wire and having proximal, intermediate and distal segments, wire turns of the proximal segment of the drive shaft having a generally constant diameter, turns of the intermediate segment of the drive shaft having a diameter that progressively increases distally through a proximal portion of such intermediate segment and having a diameter that progressively decreases distally through a distal portion of such intermediate segment to a diameter not larger than the diameter of the proximally segment of the drive shaft, thereby defining an enlarged diameter segment of the drive shaft, at least part of the enlarged diameter intermediate segment including an external coating of diamond chips secured directly to the drive shaft wire by a bonding material to define an abrasive segment of the drive shaft, the coating of diamond chips being of a generally uniform thickness throughout the length of the abrasive segment and the thickness of the bonding material between substantially all of the diamond chips and the drive shaft being not more than about 15 μ

m, the atherectomy device further including a bushing disposed within the intermediate segment of the drive shaft, the bushing having an outer surface engaging and supporting the wire turns of at least the central portion of the intermediate segment, the bushing having an inner longitudinal bore therethrough which is generally coaxial with the drive shaft lumen, the bushing bore having a low friction inner surface and being sized to receive the guide wire therein.

48. The abrasive drive shaft atherectomy device of claim 47 wherein the bushing is sonolucent, and the intermediate segment of the drive shaft includes a gap between adjacent wire turns to define a sonolucent window located generally between the proximal and distal portions of the intermediate segment of the drive shaft, the abrasive drive shaft atherectomy device further including an intravascular ultrasonic imaging probe carrying ultrasonic imaging means for imaging tissue of interest, the probe being advancable into the central lumen of the drive shaft to a position acoustically aligning the ultrasonic imaging means within the sonolucent window in the intermediate segment of the drive shaft, permitting acoustic signals generated by the ultrasonic imaging means to propagate through the sonolucent window.

49. An abrasive drive shaft atherectomy device comprising a flexible, elongated drive shaft having a central lumen for receipt of a guide wire therein around which the drive shaft may be rotated, the drive shaft being comprised of at least one helically wound wire and having proximal, intermediate and distal segments, wire turns of the proximal segment of the drive shaft having a generally constant diameter, turns of the intermediate segment of the drive shaft having a diameter that progressively increases distally through a proximal portion of such intermediate segment and having a diameter that progressively decreases distally through a distal portion of such intermediate segment, thereby defining an enlarged diameter segment of the drive shaft, at least part of the enlarged diameter intermediate segment including an external coating of an abrasive material to define an abrasive segment of the drive shaft, the device further including a bushing disposed within the intermediate segment of the drive shaft, the bushing having an outer surface engaging and supporting the wire turns of at least a central portion of the intermediate segment, and having an inner longitudinal bore therethrough, the bore being generally coaxial with the drive shaft lumen.

50. The abrasive drive shaft atherectomy device of claim 49 wherein the wire turns of the drive shaft in the distal portion of the intermediate segment progressively decrease distally in diameter to a diameter not larger than the diameter of the wire turns of the proximal segment of the drive shaft.

51. The abrasive drive shaft atherectomy device of claim 49 wherein the intermediate segment of the drive shaft includes a gap between adjacent wire turns to define a sonolucent window in the intermediate segment.

52. The abrasive drive shaft atherectomy device of claim 51 wherein the turns of the drive shaft'"'"'s intermediate segment have a first pitch, at least one wire turn of the intermediate segment having a second, larger pitch to form the gap defining the sonolucent window in the intermediate segment.

53. The abrasive drive shaft atherectomy device of claim 51 wherein the gap is formed by a change in the pitch of the wire turns of the helically wound wire drive shaft.

54. The abrasive drive shaft atherectomy device of claim 51 wherein the gap in the intermediate segment of the drive shaft is located generally between the proximal and distal portions of the intermediate segment.

55. The abrasive drive shaft atherectomy device of claim 51 further comprising an intravascular ultrasonic imaging probe carrying ultrasonic imaging means for imaging tissue of interest, the probe being advanceable into the central lumen of the drive shaft to a position acoustically aligning the ultrasonic imaging means with the sonolucent window in the intermediate segment of the drive shaft, permitting acoustic signals generated by the ultrasonic imaging means to propagate through the sonolucent window.

56. The abrasive drive shaft atherectomy device of claim 55 wherein the ultrasonic imaging means includes an array of ultrasonic transducer elements.

57. The abrasive drive shaft atherectomy device of claim 55 wherein the abrasive drive shaft is rotatable with respect to the intravascular ultrasonic imaging probe.

58. The abrasive drive shaft atherectomy device of claim 55 wherein the ultrasonic imaging means is secured to the drive shaft for rotation together with the drive shaft.

59. The abrasive drive shaft atherectomy device of claim 55 wherein the ultrasonic imaging means comprises an ultrasonic transducer element and an acoustic reflector.

60. The abrasive drive shaft atherectomy device of claim 59 wherein the acoustic reflector is rotatable with respect to the ultrasonic transducer element.

61. The abrasive drive shaft atherectomy device of claim 59 wherein the acoustic reflector and the ultrasonic transducer element are rotatable together as a unit.

62. The abrasive drive shaft atherectomy device of claim 55 wherein the intravascular ultrasonic imaging probe comprises an intravascular ultrasonic imaging catheter.

63. The abrasive drive shaft atherectomy device of claim 55 wherein the intravascular ultrasonic imaging probe comprises an ultrasonic imaging guide wire.

64. The abrasive drive shaft atherectomy device of claim 49 wherein the intermediate segment of the drive shaft includes a gap between adjacent wire turns to define a window in the intermediate segment, the abrasive drive shaft atherectomy device further including imaging means, advanceable into the central lumen of the drive shaft to a position aligning said imaging means with the window in the intermediate segment of the drive shaft, for imaging tissue surrounding the intermediate segment of the drive shaft.

65. The abrasive drive shaft atherectomy device of claim 49 wherein the diameter of the bushing bore is sized to receive the guide wire therein.

66. The abrasive drive shaft atherectomy device of claim 49 wherein the bushing is made of a flexible material.

67. The abrasive drive shaft atherectomy device of claim 49 wherein the bushing is made of a sonolucent material.

68. The abrasive drive shaft atherectomy device of claim 67 wherein the sonolucent material is silicone.

69. The abrasive drive shaft atherectomy device of claim 49 wherein the bushing is made of a low friction material.

70. The abrasive drive shaft atherectomy device of claim 69 wherein the low friction material is polytetrafluoroethylene.

71. The abrasive drive shaft atherectomy device of claim 49 wherein the inner surface of the bushing bore is made of a low friction material.

72. The abrasive drive shaft atherectomy device of claim 49 further comprising a flexible, low friction sheath covering at least that portion of the drive shaft immediately proximal to the intermediate segment of the drive shaft.

73. The abrasive drive shaft atherectomy device of claim 72 wherein the sheath is made of polytetrafluoroethylene.

74. The abrasive drive shaft atherectomy device of claim 72 further comprising a low friction sheath covering the distal segment of the drive shaft.

75. The abrasive drive shaft atherectomy device of claim 49 further comprising a flexible, low friction coating covering at least that portion of the drive shaft immediately proximal to the intermediate segment of the drive shaft.

76. The abrasive drive shaft atherectomy device of claim 75 wherein the coating is made of polytetrafluoroethylene.

77. The abrasive drive shaft atherectomy device of claim 49 wherein the drive shaft is made from wire substantially completely coated with polytetrafluoroethylene.

78. The abrasive drive shaft atherectomy device of claim 49 wherein the abrasive material comprises a plurality of abrasive particles which are secured directly to the wire turns of the drive shaft by a bonding material.

79. The abrasive drive shaft atherectomy device of claim 49 wherein the abrasive material comprises a plurality of abrasive particles which are secured directly to the drive shaft by a bonding material.

80. The abrasive drive shaft atherectomy device of claim 78 wherein the bonding material is applied to adjacent turns of the helically wound wire to secure the abrasive material to such turns and to secure at least some of such adjacent turns to one another.

81. The abrasive drive shaft atherectomy device of claim 78 wherein the bonding material is applied to adjacent turns of the helically wound wire to secure the abrasive material to such turns without securing any of such adjacent turns to one another.

82. The abrasive drive shaft atherectomy device of claim 49 wherein the abrasive material comprises diamond chips having a largest dimension of substantially 30 μ

m or less.

83. The abrasive drive shaft atherectomy device of claim 49 wherein the coating of abrasive material is not thicker than about 48 μ

m.

84. The abrasive drive shaft atherectomy device of claim 49 wherein the maximum diameter of the abrasive segment, including the thickness of the abrasive coating, is not more than about 90 μ

m larger than the maximum outer diameter of the wire turns of the abrasive segment of the drive shaft.

85. The abrasive drive shaft atherectomy device of claim 49 wherein the coating of abrasive material is of a generally uniform thickness throughout the length of the abrasive segment.

86. The abrasive drive shaft atherectomy device of claim 49 wherein the drive shaft comprises a plurality of helically wound wires.

87. The abrasive drive shaft atherectomy device of claim 49 wherein the drive shaft is comprised of inner and outer co-axial wire layers helically wound in opposite directions so that the outer layer tends to radially contract and the inner layer tends to radially expand when the drive haft is rotated in a predetermined direction.

88. The abrasive drive shaft atherectomy device of claim 87 wherein the outer wire layer extends along substantially the entire proximal segment of the drive shaft and terminates just proximal to the intermediate segment of the drive shaft.

89. The abrasive drive shaft atherectomy device of claim 87 wherein the outer wire layer extends along substantially all of the proximal and intermediate segments, and at least partially along the distal segment of the drive shaft.

90. An abrasive drive shaft atherectomy device comprising a flexible, elongated drive shaft having a central lumen for receipt of a guide wire therein around which the drive shaft may be rotated, the drive shaft being comprised of inner and outer co-axial wire layers helically wound in opposite directions so that the outer layer tends to radially contract and the inner layer tends to radially expand when the rive shaft is rotated in a predetermined direction, the drive shaft having proximal, intermediate and distal segments, wire turns of the proximal segment of the drive shaft having a generally constant diameter, wire turns of the outer layer of the intermediate segment of the drive shaft having a diameter that progressively increases distally through a proximal portion of such intermediate segment and having a diameter that progressively decreases distally through a distal portion of such intermediate segment, thereby defining an enlarged diameter segment of the drive shaft, at least part of the enlarged diameter intermediate segment including an external coating of an abrasive material to define an abrasive segment of the drive shaft, and further including a generally toroidal collar positioned in the intermediate segment of the drive shaft between the inner and outer layers of the drive shaft.

91. The abrasive drive shaft atherectomy device of claim 90 wherein the wire turns of the outer layer of the drive shaft in the distal portion of the intermediate segment progressively decrease distally in diameter to a diameter not larger than the diameter of the wire turns of the outer layer of the proximal segment of the drive shaft.

92. The abrasive drive shaft atherectomy device of claim 90 wherein the collar is made of a flexible material.

93. The abrasive drive shaft atherectomy device of claim 90 wherein the collar is made of a metal.

94. The abrasive drive shaft atherectomy device of claim 90 wherein the collar is made of a plastic material.

95. The abrasive drive shaft atherectomy device of claim 90 further comprising a flexible, low friction sheath covering at least that portion of the drive shaft immediately proximal to the intermediate segment of the drive shaft.

96. The abrasive drive shaft atherectomy device of claim 95 wherein the sheath is made of polytetrafluoroethylene.

97. The abrasive drive shaft atherectomy device of claim 95 further comprising a low friction sheath covering the distal segment of the drive shaft.

98. The abrasive drive shaft atherectomy device of claim 90 further comprising a flexible, low friction coating covering at least that portion of the drive shaft immediately proximal to the intermediate segment of the drive shaft.

99. The abrasive drive shaft atherectomy device of claim 98 wherein the coating is made of polytetrafluoroethylene.

100. The abrasive drive shaft atherectomy device of claim 90 wherein the drive shaft is made from wire substantially completely coated with polytetrafluoroethylene.

101. The abrasive drive shaft atherectomy device of claim 90 wherein the abrasive material comprises a plurality of abrasive particles which are secured directly to the wire turns of the drive shaft by a bonding material.

102. The abrasive drive shaft atherectomy device of claim 90 wherein the abrasive material comprises a plurality of abrasive particles which are secured directly to the drive shaft by a bonding material.

103. The abrasive drive shaft atherectomy device of claim 101 wherein the bonding material is applied to adjacent turns of the helically wound wire to secure the abrasive material to such turns and to secure at least some of such adjacent turns to one another.

104. The abrasive drive shaft atherectomy device of claim 101 wherein the bonding material is applied to adjacent turns of the helically wound wire to secure the abrasive material to such turns without securing any of such adjacent turns to one another.

105. The abrasive drive shaft atherectomy device of claim 90 wherein the abrasive material comprises diamond chips having a largest dimension of substantially 30 μ

m or less.

106. The abrasive drive shaft atherectomy device of claim 90 wherein the coating of abrasive material is not thicker than about 45 μ

m.

107. The abrasive drive shaft atherectomy device of claim 90 wherein the maximum diameter of the abrasive segment, including the thickness of the abrasive coating, is not more than about 90 μ

m larger than the maximum outer diameter of the wire turns of the abrasive segment of the drive shaft.

108. The abrasive drive shaft atherectomy device of claim 90 wherein the coating of abrasive material is of a generally uniform thickness throughout the length of the abrasive segment.

109. The abrasive drive shaft atherectomy device of claim 90 wherein each layer of the drive shaft comprises a plurality of helically wound wires.

110. The abrasive drive shaft atherectomy device of claim 90 wherein the outer wire layer extends along substantially all of the proximal and intermediate segments, and at least partially along the distal segment of the drive shaft.

111. The abrasive drive shaft atherectomy device comprising a flexible, elongated drive shaft having a central lumen for receipt of a guide wire therein around which the drive shaft may be rotated, the drive shaft being comprised of at least two helically wound wires forming inner and outer co-axial wire layers helically wound in opposite directions so that the outer layer tends to radially contract and the inner layer tends to radially expand when the drive shaft is rotated in a predetermined direction;

and drive shaft having proximal, intermediate and distal segments, wire turns of the proximal segment of the drive shaft having a generally constant diameter, wire turns of the intermediate segment of the drive shaft having a diameter that progressively increases distally through a proximal portion of such intermediate segment and having a diameter that progressively decreases distally through a distal portion of such intermediate segment, thereby defining an enlarged diameter segment of the drive shaft, at least part of the enlarged diameter intermediate segment including an external coating of an abrasive material to define an abrasive segment of the drive shaft.

112. The abrasive drive shaft atherectomy device comprising a flexible, elongated drive shaft having a central lumen for receipt of a guide wire therein around which the drive shaft may be rotated, the drive shaft being comprised of at least two helically wound wires forming inner and outer co-axial wire layer helically wound in opposite directions so that the outer layer tends to radially contract and the inner layer tends to radially expand when the drive shaft is rotated in a predetermined direction, the drive shaft having proximal, intermediate and distal segments;

the outer wire layer extending along substantially the entire proximal segment of the drive shaft, terminating just proximal to the intermediate segment of the drive shaft and having a generally constant diameter;

wire turns of the inner layer of the drive shaft extending along substantially the entire length of the drive shaft, such wire turns having a generally constant diameter along substantially the entire proximal segment of the drive shaft, having a diameter that progressively increases distally through a proximal portion of the intermediate segment, and having a diameter that progressively decreases distally through a distal portion of the intermediate segment, thereby defining an enlarged diameter segment of the drive shaft, at least part of the enlarged diameter intermediate segment including an external coating of an abrasive material to define an abrasive segment of the drive shaft.

113. An abrasive drive shaft atherectomy device comprising a flexible, elongated drive shaft having a central lumen for receipt of a guide wire therein around which the drive shaft may be rotated, the drive shaft being comprised of at least two helically wound wires forming inner and outer co-axial wire layers helically wound in opposite directions so that the outer layer tends to radially contract and the inner layer tends to radially expand when the drive shaft is rotated in a predetermined direction, the drive shaft having proximal, intermediate and distal segments;

the inner wire layer extending along substantially the entire length of the drive shaft and having a generally constant diameter;

wire turns of the outer layer of the dive shaft extending along substantially all of the proximal and intermediate segments and at least partially along the distal segment of the drive shaft;

such wire turns of the outer layer having a diameter that is substantially constant along substantially the entire proximal segment of the drive shaft, that progressively increases distally through a proximal portion of the intermediate segment, and that progressively decreases distally through a distal portion of the intermediate segment, thereby defining an enlarged diameter segment of the drive shaft, at least part of the enlarged diameter intermediate segment including an external coating of an abrasive material to define an abrasive segment of the drive shaft.

114. The abrasive drive shaft atherectomy device of claim 113 further comprising a toroidal collar positioned in the intermediate segment of the drive shaft and disposed between the inner and outer layers of the drive shaft.