Methods and devices for reentering a true lumen from a subintimal space

• US 20040167554A1
• Filed: 04/22/2003
• Published: 08/26/2004
• Est. Priority Date: 12/20/2000
• Status: Abandoned Application

• Current Assignee: Foxhollow Technologies Incorporated (Medtronic Plc)
• Original Assignee: Foxhollow Technologies Incorporated (Medtronic Plc)
• Inventors: Rosenthal, Michael H., Ashley, John E., Simpson, John B., Doud, Darren G., Venegas, Gautama B.
• Application Number:
  US10/421,980
• Publication Number:
  US 20040167554A1
• Time in Patent Office: Days
• 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 17/320783 through side-hole, e.g. sliding or rotating cutter inside catheter
• CPC Class Codes: A61B 2017/00685 Archimedes screw
• CPC Class Codes: A61B 2017/22094 for crossing total occlusions, i.e. piercing
• CPC Class Codes: A61B 2017/22095 accessing a blood vessel true lumen from the sub-intimal space
• CPC Class Codes: A61B 2017/2927 the angular position of the head being adjustable with respect to the shaft
• CPC Class Codes: A61B 2017/320032 Details of the rotating or oscillating shaft, e.g. using a flexible shaft
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension

Abstract

A device for reentering a true lumen from a subintimal location includes a rotating cutting element and energy emitting element. Energy is emitted to determine the location of the true lumen and the cutting element is exposed to cut an access path to the true lumen. The cutting element may be gradually exposed and the distal portion may be bent or articulated to move the cutting element toward the material to be cut.

Claims

1. A method of re-entering a lumen during an endovascular procedure when in a subintimal space, comprising the steps of:

providing a device having a cutter, an opening, and an energy emitter coupled to the cutter, the cutter and energy emitter being coupled to a torque transmitting element which rotates the cutter and energy emitter together;

advancing the device through a lumen into a subintimal space adjacent to the lumen;

emitting energy from the energy emitter while in the subintimal space to locate the lumen after the advancing step;

moving the energy emitter and cutting element together to expose the cutting element to tissue; and

cutting through the wall using the rotating cutting element to provide an access path from the subintimal space to the lumen.

2. The method of claim 1, wherein:

the cutting step is carried out while moving the cutter and opening together through the subintimal space to create the access path into the true lumen.

3. The method of claim 1, wherein:

the providing step is carried out with the energy emitter being an ultrasound emitting element.

4. The method of claim 1, wherein:

the moving step is carried out to move at least part of the cutting element through the opening to expose the at least part of the cutting element.

5. The method of claim 1, further comprising the step of:

directing an element through the access path into the true lumen while maintaining the cutting element within the subintimal space

6. The method of claim 1, wherein:

the directing step is carried out with the element being a guidewire.

7. The method of claim 6, wherein:

the advancing step is carried out by advancing the device over the guidewire.

8. The method of claim 1, further comprising the step of:

directing an element through the device and through the access path into the true lumen.

9. The method of claim 1, wherein:

the providing step is carried out with the device having an open end;

the moving step being carried out with the cutting element moving from a position within the device to a position outside the open end to expose the cutting element.

10. The method of claim 1, wherein:

the moving step is carried out to move the cutting element to a position outside the opening.

11. The method of claim 1, wherein:

the moving step is carried out to expose over 180 degrees of the cutting element through the opening relative to an axis of rotation.

12. The method of claim 1, wherein:

the moving step is carried out to expose over 270 degrees of the cutting element relative to an axis of rotation.

13. The method of claim 1, wherein:

the moving step is carried out by gradually exposing more of the cutting element.

14. The method of claim 1, further comprising the step of:

bending a distal portion of the device before the cutting step.

15. The method of claim 14, wherein:

the bending step is carried out with an axis of rotation maintaining the same orientation relative to a proximal portion of the device.

16. The method of claim 1, wherein:

the cutting step is carried out while emitting energy with the energy emitting element.

17. The method of claim 1, further comprising the step of:

positioning a sheath proximal to the subintimal space.

18. The method of claim 17, further comprising the step of:

delivering a fluid through the sheath to determine whether the access path has been created.

19. The method of claim 17, further comprising:

advancing a guidewire through the sheath and through the access path into the true lumen.

112. The method of claim 1, further comprising the step of:

measuring a pressure to determine when the access path has been created.

20. A method of re-entering a lumen during an endovascular procedure, comprising the steps of:

providing a device having a rotatable cutter and an opening, the cutter being movable from a first position to a second position, the cutter being positioned within the opening in the first position and extending out of the opening in the second position;

advancing the device into a false lumen created during an endovascular procedure, the false lumen extending in a wall of a true lumen;

orienting the opening toward the true lumen after the advancing step;

moving the cutter into the second position so that the cutter extends out of the opening after the orienting step;

cutting an opening from the false lumen to the true lumen after the moving step; and

directing another endovascular device through the opening and into the true lumen.

21. The method of claim 20, wherein:

the orienting step is carried out using an energy emitting element.

22. The method of claim 21, wherein:

the orienting step is carried out with the energy emitting element being an ultrasound emitting element.

23. The method of claim 21, wherein:

the orienting step is carried out with the ultrasound emitting element rotating within a housing of the device.

24. The method of claim 20, wherein:

the providing step is carried out with the cutter being rotatable;

the cutting step is carried out while the cutter is rotating.

25. The method of claim 24, wherein:

the orienting step is carried out with the device having an ultrasound emitting element coupled to the cutter.

26. The method of claim 20, wherein:

the cutting step is carried out by moving the opening and the cutting element together within the false lumen.

27. The method of claim 26, wherein:

the cutting step is carried out by moving the entire device longitudinally to move the opening and the cutter relative to the wall of the true lumen.

28. The method of claim 20, further comprising the step of:

positioning a sheath proximal to the subintimal space.

29. The method of claim 28, further comprising the step of:

delivering a fluid through the sheath to determine whether the access path has been created.

30. The method of claim 28, further comprising:

advancing a guidewire through the sheath and through the access path into the true lumen.

31. The method of claim 20, wherein:

the moving step is carried out to expose over 180 degrees of the cutting element through the opening relative to an axis of rotation.

32. The method of claim 20, wherein:

the moving step is carried out to expose over 270 degrees of the cutting element relative to an axis of rotation.

33. The method of claim 20, wherein:

the moving step is carried out by gradually exposing more of the cutting element.

34. The method of claim 20, further comprising the step of:

bending a distal portion of the device before the cutting step.

35. The method of claim 34, wherein:

the bending step is carried out with an axis of rotation maintaining the same orientation relative to a proximal portion of the device.

113. The method of claim 20, further comprising the step of:

measuring a pressure to determine when an access path has been created.

36. A method of re-entering a lumen during an endovascular procedure, comprising the steps of:

providing a device having a cutter, a distal portion and a proximal portion, the distal portion being movable from a first condition to a second condition, the distal portion being angled relative to the proximal portion in the second condition;

advancing the device into a false lumen created during an endovascular procedure when the device is in the straightened condition;

moving the distal portion to the second condition to angle the distal portion after the advancing step;

orienting the opening toward a true lumen after the advancing step;

cutting an opening from the false lumen to the true lumen using the cutter; and

directing an endovascular device through the opening and into the true lumen.

37. The method of claim 36, wherein:

the directing step is carried out by directing the distal end of the device through the opening when in the second condition and then directing the endovascular device through the opening, the device being angled so that the distal portion is directed toward the access path cut during the cutting step.

38. The method of claim 36, wherein:

the directing step is carried out with the endovascular device being advanced over the device which creates the opening from the false lumen to the true lumen.

39. The method of claim 36, wherein:

the cutting step is carried out with the cutter rotating.

40. The method of claim 39, wherein:

the moving step is carried out with the cutter rotating around an axis of rotation, the axis of rotation maintaining the same orientation with respect to the proximal portion.

41. The method of claim 36, wherein:

the moving step is carried out by moving the cutter longitudinally which causes the distal portion to move to the second condition.

42. The method of claim 36, wherein:

the cutting step is carried out with the device being in the second condition; and

the directing step being carried out with the device also being in the second condition but with the device having an orientation which is about 180 degrees displaced from the orientation during the cutting step.

43. The method of claim 36, further comprising the step of:

positioning a sheath proximal to the subintimal space.

44. The method of claim 43, further comprising the step of:

delivering a fluid through the sheath to determine whether the access path has been created.

45. The method of claim 43, further comprising:

advancing a guidewire through the sheath and through the access path into the true lumen.

46. The method of claim 36, wherein:

the moving step is carried out to expose over 180 degrees of the cutting element through the opening relative to an axis of rotation.

47. The method of claim 36, wherein:

the moving step is carried out to expose over 270 degrees of the cutting element relative to an axis of rotation.

48. The method of claim 36, wherein:

the moving step is carried out by gradually exposing more of the cutting element.

49. The method of claim 36, further comprising the step of:

bending a distal portion of the device before the cutting step.

50. The method of claim 49, wherein:

the bending step is carried out with an axis of rotation maintaining the same orientation relative to a proximal portion of the device.

114. The method of claim 36, further comprising the step of:

measuring a pressure to determine when the opening into the true lumen has been created.

51. A method of cutting tissue in a blood vessel, comprising the steps of:

providing a device having a rotatable cutting element and an opening, the rotatable cutting element being movable from a stored position to a cutting position, the cutting element being exposed over at least 180 degrees in the cutting position;

advancing the device through a blood vessel;

moving the cutting element to the cutting position;

cutting tissue with the cutting element while the cutting element is rotating.

52. The method of claim 51, wherein:

the providing step is carried out with the device having a proximal portion and a distal portion, the proximal portion and the distal portion being movable relative to one another between a straight position to a bent position;

the cutting step being carried out with the device in the bent position.

53. The method of claim 52, wherein:

the cutting step is carried out with the distal portion bending relative to the proximal portion and an axis of rotation of the cutting element.

54. The method of claim 53, wherein:

the cutting step is carried out with the axis of rotation maintaining the same orientation with respect to the proximal portion when the device moves between the straight and bent positions.

55. The method of claim 51, wherein:

the providing step is carried out with the cutting element being exposed over at least 270 degrees.

56. The method of claim 51, further comprising the step of:

orienting the device so that the cutting element is exposed to cut tissue between a false lumen and a true lumen;

the advancing step being carried out with the device being positioned in the false lumen.

57. The method of claim 51, wherein:

the providing step is carried out with the device having an open end;

the moving step being carried out with the device moving through the open end into the cutting position.

58. The method of claim 51, wherein:

the providing step is carried out with the cutting element being gradually exposed from 220-240 degrees.

59. An endovascular tissue cutting device, comprising:

an elongate body having a lumen and an opening;

a torque transmitting element extending through the lumen; and

a rotatable cutter coupled to the torque transmitting element, the cutter being movable from a first position to a second position, the cutter being contained within the body in the first position and being exposed out of the opening in the second position, the rotatable cutter being exposed for over 180 degrees in the second position.

60. The device of claim 59, wherein:

the rotatable cutter is movable to a third position, the cutter being exposed for over 220 degrees in the third position.

61. The device of claim 59, wherein:

the rotatable cutter is movable to a third position, the cutter being exposed for over 270 degrees in the third position.

62. The device of claim 59, wherein:

the rotatable cutter has a gradually increasing exposure when moving toward the second position so that a user may change the amount of exposure of the cutter.

63. The device of claim 59, wherein:

the rotatable cutter gradually increases in exposure from 200-240 degrees when moving toward the second position.

64. A method of entering a true lumen from a subintimal location, comprising the steps of:

providing a device having an elongate body, a rotatable cutting element and an opening in the body, the rotatable cutting element being movable from a stored position to a cutting position, the cutting element being exposed through the opening when in the cutting position, the body being wider along a portion of the device where the cutting element is positioned in the cutting position to urge tissue toward the cutting element;

advancing the device through a blood vessel;

orienting the opening toward a true lumen;

moving the cutting element to the cutting position, wherein the wider portion of the body urges tissue toward the cutting element; and

cutting tissue with the cutting element while the cutting element is rotating.

65. The method of claim 64, wherein:

the providing step is carried out with the portion of the device where the cutting element is positioned in the cutting position exposes over 180 degrees of the cutting element.

66. The method of claim 65, wherein:

the providing step is carried out with the portion of the device where the cutting element is positioned in the cutting position exposes at least 270 degrees of the cutting element.

67. The method of claim 64, wherein:

the providing step is carried out with the device tapering distally after the wider portion, wherein the cutting element becomes increasingly exposed as the cutting element is moved distally.

68. The method of claim 64, wherein:

the providing step is carried out with the device having an open end which exposes substantially the entire cutting element when viewed along a longitudinal axis of the device.

69. The method of claim 64, further comprising the step of:

positioning a sheath proximal to the subintimal space.

70. The method of claim 69, further comprising the step of:

delivering a fluid through the sheath to determine whether the access path has been created.

71. The method of claim 69, further comprising:

advancing a guidewire through the sheath and through the access path into the true lumen.

72. A method of re-entering a lumen during an endovascular procedure, comprising the steps of:

providing a device having a rotatable cutter and an opening, the cutter being movable from a first position to a second position, the opening have a proximal side, the rotatable cutter being partially exposed at all positions distal to the proximal side after the cutter is initially exposed;

advancing the device into a false lumen created during an endovascular procedure, the false lumen extending through a wall of a true lumen, the cutter being positioned proximal to the proximal side of the opening;

orienting the opening toward the true lumen after the advancing step;

moving the cutter distally beyond the proximal side of the cutter so that the cutter extends out of the opening after the orienting step;

cutting an opening from the false lumen to the true lumen using the rotating cutter after the moving step; and

directing another endovascular device through the opening and into the true lumen.

73. The method of claim 72, wherein:

the providing step is carried out with the rotatable cutter being coupled to an energy emitting element which is coupled to the cutter; and

the orienting step being carried out by emitting energy from the energy emitting element to orient the opening.

74. The method of claim 73, wherein:

the moving step is carried out while emitting energy from the energy emitting element.

75. The method of claim 72, wherein:

the cutting step is carried out by moving the entire device longitudinally so that the rotating cutter translates within the false lumen to cut through the wall to the true lumen.

76. The method of claim 72, wherein:

the providing step is carried out with the device having a lumen in communication with the opening.

77. The method of claim 76, further comprising the step of:

introducing a fluid through the lumen.

78. The method of claim 76, wherein:

the introducing step is carried out with the fluid being contrast.

79. The method of claim 76, further comprising the step of:

measuring a pressure through the lumen.

80. The method of claim 72, further comprising the step of:

positioning a sheath proximal to the subintimal space.

82. The method of claim 80, further comprising:

advancing a guidewire through the sheath and through the access path into the true lumen.

83. The method of claim 72, wherein:

the moving step is carried out to expose over 180 degrees of the cutting element through the opening relative to an axis of rotation.

84. The method of claim 72, wherein:

the moving step is carried out to expose over 270 degrees of the cutting element relative to an axis of rotation.

85. The method of claim 72, wherein:

the moving step is carried out by gradually exposing more of the cutting element.

86. The method of claim 72, further comprising the step of:

bending a distal portion of the device before the cutting step.

87. The method of claim 86, wherein:

the bending step is carried out with an axis of rotation maintaining the same orientation relative to a proximal portion of the device.

81. The method of claim A80, further comprising the step of:

delivering a fluid through the sheath to determine whether the access path has been created.

88. A method of re-entering a lumen during an endovascular procedure, comprising the steps of:

providing a device having a rotatable cutter and an opening, the cutter being movable relative to the opening between a first position and a second position, the cutter being increasingly exposed when moving from the first position to the second position;

advancing the device into a false lumen created during an endovascular procedure, the false lumen extending in a wall of a true lumen;

orienting the opening toward the true lumen after the advancing step;

moving the cutter from the first position toward the second position to expose part of the cutter;

determining whether an access path has been created from the false lumen to the true lumen;

increasing the amount of the cutter that is exposed until the access path has been created; and

directing another endovascular device through the opening and into the true lumen.

89. The method of claim 88, wherein:

the providing step is carried out with the cutter being exposed for over 180 degrees when in the second position.

90. The method of claim 89, wherein:

the providing step is carried out with the cutter being exposed for over 220 degrees when in the second position.

91. The method of claim 88, wherein:

the providing step is carried out with the cutter being having a gradually increasing exposure when moving toward the second position.

92. The method of claim 91, wherein:

the providing step is carried out with the cutter being increasing exposed from at least 180 degrees to at least 220 degrees when moving from the first position to the second position.

93. The method of claim 88, further comprising the step of:

positioning a sheath proximal to the subintimal space.

94. The method of claim 93, further comprising the step of:

delivering a fluid through the sheath to determine whether the access path has been created.

95. The method of claim 93, further comprising:

advancing a guidewire through the sheath and through the access path into the true lumen.

115. The method of claim 88, further comprising the step of:

measuring a pressure to determine when the access path has been created.

96. An intravascular incising device, comprising:

an elongate body, the body having at least one lumen and being sufficiently flexible to be advanced through a patient'"'"'s vasculature to a treatment site;

a torque transmitting element extending through the lumen;

a cutting element coupled to the torque transmitting element, the cutting element being movable relative to the opening to a number of discrete positions to vary an amount of the cutting element which is exposed relative to the opening.

97. The device of claim 96, wherein:

the cutting element is movable from a stored position in which the cutting element is not exposed to a working position where the cutting element is exposed at least 180 degrees relative to the opening.

98. The device of claim 96, wherein:

the cutting element is movable from a stored position in which the cutting element is not exposed to a working position where the cutting element is exposed at least 180 degrees relative to the opening.

99. The device of claim 96, wherein:

the cutting element is movable from a stored position in which the cutting element is not exposed to a working position where the cutting element is exposed at least 270 degrees relative to the opening.

100. The device of claim 96, wherein:

the cutting element may be gradually exposed between 180-220 degrees.

101. The device of claim 96, wherein:

the cutting element may be gradually exposed between 200-270 degrees.

102. The device of claim 96, wherein:

the cutting element may be moved longitudinally relative to the body for moving the cutting element between the number of discrete positions.

103. A method of entering a true lumen from a false lumen during an endovascular procedure, comprising the steps of:

providing a guidewire and a reentry device;

positioning the guidewire at a subintimal space;

advancing the reentry device over the guidewire to the target location;

cutting an access path from the subintimal space to a true lumen; and

directing the guidewire through the access path into the true lumen.

104. The method of claim 103, further comprising the step of:

advancing an endovascular device over the guidewire and through the access path.

105. The method of claim 103, wherein:

the directing step is carried out by directing the guidewire through a different distal opening than during the advancing step.

106. The method of claim 105, wherein:

the directing step is carried out with the device having a junction with a first arm and a second arm;

the advancing step being carried out with the guidewire passing through the first arm; and

the directing step is carried out with the guidewire passing through the second arm of the junction.

107. The method of claim 103, wherein:

the directing step is carried out with a distal portion of the device being bent.

108. The method of claim 103, wherein:

the directing step is carried out with the reentry device extending through the access path, the guidewire being advanced through the reentry device while the reentry device is positioned in the access path.

109. The method of claim 103, further comprising the step of:

positioning a sheath proximal to the subintimal space.

110. The method of claim 109, further comprising the step of:

delivering a fluid through the sheath to determine whether the access path has been created.

111. The method of claim 109, further comprising:

advancing another guidewire through the sheath and through the access path into the true lumen.

116. The method of claim 103, further comprising the step of:

measuring a pressure to determine when the access path has been created.