Devices and methods for controlling and indicating the length of an interventional element

• US 20050149159A1
• Filed: 12/23/2003
• Published: 07/07/2005
• Est. Priority Date: 12/23/2003
• Status: Active Grant

• Current Assignee: JW Medical Systems Ltd
• Original Assignee: XTENT, Inc.
• Inventors: Andreas, Bernard, Flom, James R., Blackwood, Bradley, Karratt, Joseph
• Granted Patent: US 7,326,236 B2
• Time in Patent Office: Days
• US Class Current: 623/1.110
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2250/0097 Visible markings, e.g. indicia
• CPC Class Codes: A61M 2025/0008 having visible markings on its surface, i.e. visible to the naked eye, for any purpose, e.g. insertion depth markers, rotational markers or identification of type
• CPC Class Codes: A61M 2025/1068 having means for varying the length or diameter of the deployed balloon, this variations could be caused by excess pressure
• CPC Class Codes: A61M 25/0136 Handles therefor

Abstract

Devices and methods are provided for controlling and indicating the deployed length of an interventional element on an interventional catheter. The interventional element may be a stent or series of stents, a balloon, or any other interventional element for which length control is necessary or desirable. Devices for controlling the length of the interventional element include gear driven actuators, motors, and other mechanisms. Devices for indicating length of an interventional element to the user include sensors, detents, visual displays and other mechanisms providing visual, audible, and tangible indications of length to the user. The control and indication devices preferably work in tandem to enable highly precise adjustment of interventional element length.

Claims

1. A catheter comprising:

an elongated flexible shaft having a distal end and a proximal end;

an interventional element at the distal end, the interventional element having an adjustable length,

an actuator at the proximal end for adjusting the length of the interventional element; and

an indication device at the proximal end for indicating the length.

2. The catheter of claim 1 wherein the interventional element comprises a balloon.

3. The catheter of claim 2 further comprising a sheath slidably disposed over the balloon, actuator being coupled to the sheath to axially reposition the sheath relative to the balloon.

4. The catheter of claim 1 wherein the interventional element comprises a stent releasably coupled to the shaft.

5. The catheter of claim 4 wherein the actuator controls the length of a deployable portion of the stent, the deployable portion being released from the shaft while an undeployed portion of the stent remains coupled to the shaft.

6. The catheter of claim 1 wherein the actuator is movable through a distance correlated with the length.

7. The catheter of claim 1 wherein the actuator is movable through a stroke, each stroke of the actuator adjusting the length a predetermined amount.

8. The catheter of claim 1 wherein the indication device comprises a stop that limits the movement of the actuator.

9. The catheter of claim 1 wherein the indication device comprises a sensor for detecting the length of the interventional element.

10. The catheter of claim 9 wherein the sensor is disposed near a distal end of the shaft, the sensor being coupled to an indicator at the proximal end.

11. The catheter of claim 9 wherein the sensor is optical.

12. The catheter of claim 9 wherein the sensor is magnetic.

13. The catheter of claim 9 further comprising a display associated with the sensor for displaying an indication of the length.

14. The catheter of claim 1 wherein the indication device provides a visual indication of the length.

15. The catheter of claim 1 wherein the indication device emits an audible indication of the length.

16. The catheter of claim 1 wherein the indication device provides a tactile indication of the length.

17. The catheter of claim 1 wherein the indication device comprises a plurality of holes and a movable detent, each hole being configured to receive the detent, whereby adjusting the length moves the detent from one hole to another hole.

18. The catheter of claim 17 wherein the reception of the detent in one of the holes provides a tactile indication of the length of the interventional element.

19. The catheter of claim 1 wherein the actuator comprises a ratchet mechanism that allows adjustment of the length in a first direction and prevents adjustment of the length in a second direction.

20. A catheter comprising:

an elongated flexible shaft having a distal end a proximal end;

an expandable member mounted at the distal end of the shaft, the expandable member being expandable to an expanded configuration having an expanded length;

a sheath axially movable relative to the shaft and being positionable around at least a portion of the expandable member to restrain the expansion thereof;

an actuator at the proximal end for controlling the position of the sheath relative to the expandable member to adjust the expanded length; and

an indication device on the catheter for indicating the expanded length.

21. The catheter of claim 20 further comprising at least one stent releasably positioned over the expandable member.

22. The catheter of claim 21 wherein the actuator controls the length of a deployable portion of the stent, the deployable portion being released from the shaft while an undeployed portion of the stent remains coupled to the shaft.

23. The catheter of claim 20 wherein the actuator is movable through a distance correlated with the expandable length.

24. The catheter of claim 20 wherein the actuator is movable through a stroke, each stroke of the actuator adjusting the expandable length a predetermined amount.

25. The catheter of claim 20 wherein the indication device comprises a stop that limits the movement of the actuator.

26. The catheter of claim 20 wherein the indication device comprises a sensor for detecting the length of the interventional element.

27. The catheter of claim 26 wherein the sensor is disposed near a distal end of the shaft, the sensor being coupled to an indicator at the proximal end.

28. The catheter of claim 26 wherein the sensor is optical

29. The catheter of claim 26 wherein the sensor is magnetic.

30. The catheter of claim 26 further comprising a display associated with the sensor for displaying an indication of the length.

31. The catheter of claim 20 wherein the indication device provides a visual indication of the length.

32. The catheter of claim 20 wherein the indication device emits an audible indication of the length.

33. The catheter of claim 20 wherein the indication device provides a tactile indication of the length.

34. The catheter of claim 20 wherein the indication device comprises a plurality of holes and a movable detent, each hole being configured to receive the detent, whereby adjusting the length moves the detent from one hole to another hole.

35. The catheter of claim 34 wherein the reception of the detent in one of the holes provides a tactile indication of the length of the interventional element.

36. The catheter of claim 20 wherein the actuator comprises a ratchet mechanism that allows adjustment of the length in a first direction and prevents adjustment of the length in a second direction.

37. A stent delivery catheter comprising:

an elongated flexible shaft having distal and proximal ends;

a stent releasably mounted at the distal end, a deployable portion of the stent being releasable from the catheter to assume an expanded configuration, the deployable portion having a length;

an actuator at the proximal end for controlling the length of the deployable portion; and

an indication device on the catheter for indicating the length of the deployable portion.

38. The catheter of claim 37 wherein the actuator is movable through a distance correlated with the length.

39. The catheter of claim 37 wherein the actuator is movable through a stroke, each stroke of the actuator adjusting the length a predetermined amount.

40. The catheter of claim 39 wherein the stent comprises a plurality of stent segments, and the stroke corresponds to a segment length of one of the stent segments.

41. The catheter of claim 37 wherein the indication device comprises a stop that limits the movement of the actuator.

42. The catheter of claim 37 wherein the indication device comprises a sensor for detecting the length of the interventional element.

43. The catheter of claim 42 wherein the sensor is disposed near a distal end of the shaft, the sensor being coupled to an indicator at the proximal end.

44. The catheter of claim 42 wherein the sensor is optical

45. The catheter of claim 42 wherein the sensor is magnetic.

46. The catheter of claim 42 further comprising a display associated with the sensor for displaying an indication of the length.

47. The catheter of claim 37 wherein the indication device provides a visual indication of the length.

48. The catheter of claim 37 wherein the indication device emits an audible indication of the length.

49. The catheter of claim 37 wherein the indication device provides a tactile indication of the length.

50. The catheter of claim 37 wherein the indication device comprises a plurality of holes and a movable detent, each hole being configured to receive the detent, whereby adjusting the length moves the detent from one hole to another hole.

51. The catheter of claim 50 wherein the reception of the detent in one of the holes provides a tactile indication of the length of the interventional element.

52. The catheter of claim 37 wherein the actuator comprises a ratchet mechanism that allows adjustment of the length in a first direction and prevents adjustment of the length in a second direction.

53. The catheter of claim 37 wherein the stent comprises a plurality of separable stent segments.

54. The catheter of claim 53 wherein the catheter further comprises a sheath slidable relative to the stent segments for selectively covering a first portion of the stent segment and exposing a second portion of the stent segments.

55. The catheter of claim 54 wherein the actuator moves the sheath relative to the stent segments.

56. The catheter of claim 53 wherein the actuator is further adapted to axially separate a first stent segment from a second stent segment prior to expansion thereof.

57. The catheter of claim 56 wherein the actuator is adapted to separate the first and second stent segments by a predetermined distance.

58. The catheter of claim 56 wherein the actuator has a first position for controlling the number of stent segments in the deployable portion and a second position for controlling the separation between the first and second stent segments.

59. The catheter of claim 53 wherein the indication device indicates a number of stent segments in the deployable portion.

60. The catheter of claim 37 wherein an undeployed portion of the stent remains on the catheter after the deployable portion is released from the catheter, further comprising an indication device for indicating the length of the undeployed portion.

61. A method of using an interventional catheter at a target site in a patient'"'"'s body, the method comprising:

positioning an interventional element of the interventional catheter near the target site, a proximal portion of the interventional catheter being disposed outside the patient'"'"'s body;

adjusting a working length of the interventional element with the interventional element remaining positioned in the patient'"'"'s body;

receiving from the proximal portion of the interventional catheter an indication of the working length; and

after receiving the indication, deploying the interventional element.

62. The method of claim 61 wherein the interventional element comprises a balloon, and adjusting the working length comprises constraining a first portion of the balloon from expansion while leaving a second portion of the balloon unconstrained from expansion.

63. The method of claim 62 wherein constraining comprises covering the first portion of the balloon by a sheath movably disposed on the interventional catheter.

64. The method of claim 63 wherein the sheath is coupled to an indicator, the indication of working length being received from the indicator, wherein moving the sheath changes the indication received from the indicator.

65. The method of claim 62 wherein the indication of the working length comprises an indication of the length of the second portion.

66. The method of claim 61 wherein receiving the indication of working length comprises observing a visual indication.

67. The method of claim 66 wherein the visual indication comprises one or more indicia displayed on the proximal portion of the interventional catheter.

68. The method of claim 61 wherein receiving the indication of working length comprises hearing an audible indication.

69. The method of claim 61 wherein receiving the indication of working length comprises feeling a tactile indication.

70. The method of claim 69 wherein the tactile indication is received from a detent engaging a detent receiving structure associated with the interventional catheter.

71. The method of claim 61 further comprising, after deploying the interventional element:

positioning the interventional element near a second target site;

adjusting the working length of the interventional element to a second working length;

receiving from the interventional catheter a second indication of the second working length; and

after receiving the second indication, re-deploying the interventional element.

72. A method of deploying a stent at a target site in a patient'"'"'s body, the method comprising:

positioning a distal end of a delivery catheter near the target site, the stent being releasably coupled to the distal end, a proximal portion of the delivery catheter being disposed outside the patient'"'"'s body;

adjusting the length of a deployable portion of the stent with the delivery catheter positioned in the patient'"'"'s body;

receiving an indication of the length from the proximal portion of the delivery catheter; and

after receiving the indication, deploying the deployable portion of the stent at the target site.

73. The method of claim 72 wherein adjusting the length of the deployable portion comprises moving an actuator associated with the proximal portion of the delivery catheter through a distance correlated with the length.

74. The method of claim 73 wherein the actuator is movable through a stroke, each stroke of the actuator adjusting the length a predetermined amount.

75. The method of claim 74 wherein the stent comprises a plurality of stent segments, and the stroke corresponds to a segment length of one of the stent segments.

76. The method of claim 73 wherein the indication device comprises a stop that limits the movement of the actuator.

77. The catheter of claim 72 wherein the indication of the length is received from an output device associated with the proximal end of the catheter.

78. The method of claim 77 wherein the output device is coupled to a sensor, the method further comprising detecting the length with the sensor.

79. The method of claim 78 wherein the sensor is disposed near the distal end of the delivery catheter.

80. The method of claim 78 wherein the sensor optically detects the working length.

81. The method of claim 78 wherein the sensor magnetically detects the working length.

82. The method of claim 72 wherein receiving the indication of the length comprises observing a visual indication.

83. The method of claim 82 wherein the visual indication comprises indicia displayed on the proximal portion of the delivery catheter.

84. The method of claim 72 wherein receiving the indication of length comprises hearing an audible indication.

85. The method of claim 72 wherein receiving the indication of length comprises feeling a tactile indication.

86. The method of claim 85 wherein the tactile indication is received from a detent engaging a detent receiving structure associated with the delivery catheter.

87. The method of claim 72 wherein adjusting the length comprises moving a ratchet mechanism to adjust the length in a first direction, the ratchet preventing adjustment of the length in a second direction.

88. The method of claim 72 wherein the stent comprises a plurality of separable stent segments and adjusting the length comprises constraining at least a first stent segment from expansion while leaving at least a second stent segment unconstrained from expansion.

89. The method of claim 88 wherein adjusting the length comprises moving a sheath relative to the stent segments for selectively covering the first stent segment and exposing the second stent segment.

90. The method of claim 88 wherein the indication is correlated with the number of stent segments.

91. The method of claim 89 wherein the indication is correlated with movement of the sheath relative to the stent.

92. The method of claim 88 further comprising axially separating the first stent segment from the second stent segment prior to expansion thereof.

93. The method of claim 92 further comprising moving the actuator to a first position for controlling the number of stent segments in the deployable portion and moving the actuator to a second position for controlling the separation between the first and second stent segments.