Shape lockable apparatus and method for advancing an instrument through unsupported anatomy

• US 6,790,173 B2
• Filed: 06/13/2002
• Issued: 09/14/2004
• Est. Priority Date: 06/13/2002
• Status: Expired due to Term

• Current Assignee: USGI Medical, Inc.
• Original Assignee: USGI Medical, Inc.
• Inventors: Saadat, Vahid, Chen, Eugene G., Ewers, Richard C.
• Primary Examiner(s): FLANAGAN, BEVERLY MEINDL
• Application Number:
  US10/173,227
• Publication Number:
  US 20030233026A1
• Time in Patent Office: 824 Days
• Field of Search: 600/114, 600/115, 600/117, 600/118, 600/121, 600/127, 600/129, 600/139, 600/140, 600/141, 600/142, 600/143, 600/144, 600/146, 600/150, 600/151
• US Class Current: 600/114
• CPC Class Codes: A61B 1/00078 with stiffening means
• CPC Class Codes: A61B 1/0008 characterised by distal tip features
• CPC Class Codes: A61B 1/00082 Balloons
• CPC Class Codes: A61B 1/00105 characterised by modular construction
• CPC Class Codes: A61B 1/00135 Oversleeves mounted on the endoscope prior to insertion
• CPC Class Codes: A61B 1/00154 using guiding arrangements for insertion
• CPC Class Codes: A61B 1/0052 Constructional details of control elements, e.g. handles
• CPC Class Codes: A61B 1/0055 Constructional details of insertion parts, e.g. vertebral elements
• CPC Class Codes: A61B 1/0058 using shape-memory elements
• CPC Class Codes: A61B 1/008 Articulations
• CPC Class Codes: A61B 1/31 for the rectum, e.g. proctoscopes, sigmoidoscopes , colonoscopes
• CPC Class Codes: A61B 1/32 Devices for opening or enlarging the visual field, e.g. of a tube of the body dilators A61M29/00

Abstract

Apparatus and methods are provided for placing and advancing a diagnostic or therapeutic instrument in a hollow body organ of a tortuous or unsupported anatomy, comprising a handle, an overtube, a distal region having an atraumatic tip. The overtube may be removable from the handle, and have a longitudinal axis disposed at an angle relative to the handle. The overtube may be selectively stiffened to reduce distension of the organ caused by advancement of the diagnostic or therapeutic instrument. The distal region permits passive steering of the overtube caused by deflection of the diagnostic or therapeutic instrument while the atraumatic tip prevents the wall of the organ from becoming caught or pinched during manipulation of the diagnostic or therapeutic instrument.

Claims

1. Apparatus for advancing a first diagnostic or therapeutic instrument having a steerable distal tip into a hollow body organ of unsupported anatomy, the apparatus comprising:

a handle;

an overtube coupled to the handle, the overtube having a elongated portion, a distal region and a lumen extending therethrough to permit passage of the first diagnostic or therapeutic instrument; and

an atraumatic tip disposed on the distal region,

wherein the distal region comprises a flexible material deflectable by the steerable distal tip of the first diagnostic or therapeutic instrument.

2. The apparatus of claim 1 wherein the overtube includes means for locking the overtube in a bent configuration.

3. The apparatus of claim 2 wherein the means for locking the overtube in a bent configuration comprises:

a plurality of nestable elements;

a plurality of tension wires that thread the nested elements together; and

a tensioning mechanism that may be releasably coupled to the plurality of tension wires and to selectively apply a clamping load to the plurality of nestable elements.

4. The apparatus of claim 3 wherein the tensioning mechanism is a ratchet-type tensioning mechanism.

5. The apparatus of claim 2 wherein the means for locking the overtube in a bent configuration comprises:

a plurality of links, each link having a bore that defines the lumen of the overtube; and

means for applying a clamping load to the plurality of links.

6. The apparatus of claim 5 wherein the plurality of links comprise:

a plurality of spool links, each one of the spool links having rounded distal and proximal ends; and

a plurality of clamp links, each one of the clamp links interposed between adjacent ones of the plurality of spool links, each one of the clamp links having an interior surface having grooves adapted to engage a distal end of a first adjacent spool link and a proximal end of a second adjacent spool link.

7. The apparatus of claim 5 wherein the plurality of links comprise:

a multiplicity of helical links formed from a material having variable durometer, each helical link having a rigid portion and a soft portion.

8. The apparatus of claim 5 wherein the means for applying a clamping load comprises an elongate inflatable sleeve disposed to surround the plurality of links.

9. The apparatus of claim 8 wherein the elongate inflatable sleeve comprises a plurality of interconnected annular bladders.

10. The apparatus of claim 8 wherein the elongate inflatable sleeve has a helical shape.

11. The apparatus of claim 5 wherein the means for applying a clamping load comprises:

a plurality of discontinuous, circular hoops made of a shape memory alloy; and

a plurality of insulated wires that connect the plurality of hoops to an electrical source.

12. The apparatus of claim 2 wherein the means for locking the overtube in a bent configuration comprises:

a heat-sot tenable layer having an embedded wire, wherein an electric current passing through the embedded wire softens the heat-softenable layer.

13. The apparatus of claim 2 wherein the means for locking the overtube in a bent configuration comprises:

a soft layer having an embedded shape memory alloy wire.

14. The apparatus of claim 1 wherein the overtube further comprises a distal opening, and the atraumatic tip deflects the hollow body organ in the vicinity of the distal opening so that tissue is not caught or pinched when the first diagnostic or therapeutic instrument is translated through the distal opening.

15. The apparatus of claim 1 wherein the atraumatic tip comprises an inflatable donut-shaped balloon.

16. The apparatus of claim 1 wherein the atraumatic tip comprises a wire petal having an elastomeric covering.

17. The apparatus of claim 1 wherein the atraumatic tip comprises a foam or soft elastomer bumper.

18. The apparatus of claim 1 wherein the overtube includes means for facilitating passage of the first diagnostic or therapeutic instrument through the lumen of the overtube.

19. The apparatus of claim 1 further comprising a coil disposed within at least a portion of the distal region.

20. The apparatus of claim 1 wherein the lumen is dimensioned to permit passage of a second diagnostic or therapeutic instrument alongside the first diagnostic or therapeutic instrument.

21. A method for advancing a first diagnostic or therapeutic instrument having a steerable distal tip into an unsupported, hollow body organ, the method comprising:

providing an apparatus having a handle, an overtube coupled to the handle, the overtube comprising an elongated portion having a distal opening, a lumen extending therethrough to permit passage of the first diagnostic or therapeutic instrument, and a flexible distal region, and an atraumatic tip disposed on the flexible distal region;

inserting the first diagnostic or therapeutic instrument through the lumen so that the steerable distal tip is aligned with the flexible distal region; and

navigating the first diagnostic or therapeutic instrument together with the overtube through the unsupported, hollow body organ by steering the steerable distal tip of the first diagnostic or therapeutic instrument, thereby deflecting the flexible distal region of the overtube.

22. The method of claim 21 further comprising:

locking the overtube in a bent configuration; and

advancing the first diagnostic or therapeutic instrument through the lumen of the overtube in the bent configuration.

23. The method of claim 22 wherein providing an apparatus comprises providing an apparatus wherein the overtube comprises a plurality of nestable elements, and a tensioning mechanism that selectively applies a clamping load to the plurality of nestable elements, and locking the overtube in a bent configuration comprises actuating the tensioning mechanism.

24. The method of claim 22 wherein providing an apparatus comprises providing an apparatus wherein the overtube comprises a plurality of links, each link having a bore that defines the lumen of the overtube, and locking the overtube in a bent configuration comprises applying a clamping load to the plurality of links.

25. The method of claim 24 wherein the overtube further comprises an elongate inflatable sleeve disposed to surround the plurality of links, and applying a clamping load to the plurality of links comprises inflating the elongate inflatable sleeve.

26. The method of claim 24 wherein the overtube further comprises a plurality of discontinuous, circular hoops made of a shape memory alloy, and applying a clamping load to the plurality of links comprises inducing the plurality of discontinuous, circular hoops to undergo a phase transition.

27. The method of claim 22 wherein providing an apparatus comprises providing an apparatus wherein the overtube comprises a heat-softenable layer having an embedded wire, and locking the overtube in a bent configuration comprises terminating a supply of electrical energy to the embedded wire.

28. The method of claim 22 wherein providing an apparatus comprises providing an apparatus wherein the overtube comprises a soft layer having an embedded shape memory alloy wire, and locking the overtube in a bent configuration comprises heating the embedded shape memory alloy wire.

29. The method of claim 21 further comprising deflecting the unsupported, hollow body organ with the atraumatic tip so that tissue is not caught or pinched when the first diagnostic or therapeutic instrument is translated through the distal opening.

30. The method of claim 29 wherein providing an apparatus comprises providing an apparatus wherein the atraumatic tip comprises an inflatable donut shaped balloon, and deflecting the unsupported, hollow body organ comprises inflating the inflatable donut shaped balloon.

31. The method of claim 29 wherein providing an apparatus comprises providing an apparatus wherein the atraumatic tip comprises a wire petal having an elastomeric covering, and deflecting the unsupported, hollow body organ comprises extending the wire petal in a radially-outwardly direction.

32. The method of claim 29 wherein providing an apparatus comprises providing an apparatus wherein the atraumatic tip comprises a foam or soft elastomer bumper, and deflecting the unsupported, hollow body organ comprises contacting the foam or soft elastomer bumper against the unsupported, hollow body organ.

33. The method of claim 21, wherein providing an apparatus comprises providing an apparatus wherein the lumen is dimensioned to permit passage of a second diagnostic or therapeutic instrument alongside the first diagnostic or therapeutic instrument, the method further comprising:

advancing the second diagnostic or therapeutic instrument alongside the first diagnostic or therapeutic instrument.

34. A method of advancing an instrument along an arbitrary path, comprising:

selectively steering a distal portion of the instrument to assume a selected shape along an arbitrary path;

advancing the instrument distally while configuring a controllable portion of the instrument to assume the selected shape of the distal portion, wherein the controllable portion is proximal of the distal portion;

advancing an elongate guide along the instrument such that a portion of the guide conforms to and assumes the selected shape; and

maintaining a position of the guide while advancing the instrument along the guide such that a proximal portion of the instrument assumes the selected shape defined by the guide,

wherein the elongate guide is freely slidable along the instrument such that advancing of the instrument along the guide is unconstrained.

35. The method of claim 34 further comprising measuring a depth change of the instrument while advancing the instrument distally.

36. The method of claim 35 further comprising incrementing a current depth by the depth change.

37. The method of claim 34 further comprising releasing the position of the guide and further advancing the guide along the instrument.

38. The method of claim 34 further comprising withdrawing the guide from the instrument.

39. The method of claim 34 wherein the elongate guide is advanced along by passing the instrument through a lumen within the elongate guide.

40. The method of claim 34 wherein the distal portion of the instrument selectively assumes a second shape when the instrument is advanced along the guide.

41. The method of claim 34 wherein maintaining the position of the guide comprises rigidizing the guide such that the guide rigidly assumes a position of the selected shape.

42. The method of claim 41 wherein rigidizing the guide comprises applying tension to a tensioning member disposed within the guide such that a plurality of adjacent segments comprising the guide are compressed.

43. The method of claim 41 wherein rigidizing the guide comprises applying a compressive force to an exterior of the elongate guide such that a plurality of adjacent segments comprising the guide are compressed.

44. An apparatus for insertion into a body cavity, comprising:

an elongate body having a proximal portion and a selectively steerable distal portion and defining a lumen therebetween, the steerable distal portion being configurable to assume a selected shape along an arbitrary path;

an elongate guide having a proximal section, a distal section, and a length therebetween, the guide being slidably disposed without constraint over the elongate body to selectively support the elongate body,

wherein the guide is configured to conform to and selectively maintain the selected shape assumed by the steerable distal portion, and wherein the proximal portion of the elongate body when advanced distally is configured to conform to the selected curve maintained by the guide.

45. The apparatus of claim 44 further comprising a controllable portion located proximally of the distal portion, wherein the controllable portion is configured to propagate the selected shape to the controllable portion.

46. The apparatus of claim 45 wherein the selectively steerable distal portion is configurable via a control located externally of the body cavity.

47. The apparatus of claim 44 wherein the proximal section comprises a flexible tubular member.

48. The apparatus of claim 47 wherein the elongate guide comprises a plurality of pivotally connected segments.

49. The apparatus of claim 44 wherein the elongate guide is configured to assume the selected shape when the guide is in a flexible state and wherein the guide is further configured to maintain the selected shape when the guide is in a rigidized state.

50. The apparatus of claim 49 wherein the elongate guide is configured to selectively rigidize along the length of the guide to maintain the selected shape in the rigidized state.

51. The apparatus of claim 49 wherein the proximal section of the elongate guide is in communication with a guide controller for selectively rigidizing the guide along its length.

52. The apparatus of claim 49 wherein the elongate guide comprises a plurality of adjacent segments each defining a channel therethrough such that a common channel is defined through the length of the guide.

53. The apparatus of claim 52 further comprising a tensioning member slidably extending through the plurality of adjacent segments such that applying a force to the tensioning member compresses the adjacent segments together.

54. The apparatus of claim 52 wherein the elongate guide is configured to maintain a position of adjacent segments relative to each other upon applying a compressive force to an exterior of the plurality of adjacent segments.

55. The apparatus of claim 54 further comprising an expandable balloon.

56. The apparatus of claim 44 further comprising a tubular covering disposed over at least a majority of the length of the elongate guide.

57. A method of advancing an instrument along an arbitrary path, comprising:

selectively steering a distal portion of the instrument to assume a selected shape along an arbitrary path;

advancing an elongate guide along the instrument such that a portion of the guide conforms to and assumes the selected shape;

maintaining a position of the guide while advancing the instrument along the guide such that a proximal portion of the instrument assumes the selected shape defined by the guide; and

measuring a depth change of the instrument while advancing the instrument distally,

wherein the elongate guide is freely slidable along the instrument such that advancing of the instrument along the guide is unconstrained.

58. The method of claim 57 wherein, prior to advancing the elongate guide along the instrument, further comprising advancing the instrument distally while configuring a controllable portion of the instrument to assume the selected shape of the distal portion, wherein the controllable portion is proximal of the distal portion.

59. The method of claim 57 further comprising incrementing a current depth by the depth change.

60. The method of claim 57 further comprising releasing the position of the guide and further advancing the guide along the instrument.

61. The method of claim 57 further comprising withdrawing the guide from the instrument.

62. The method of claim 57 wherein the elongate guide is advanced along by passing the instrument through a lumen within the elongate guide.

63. The method of claim 57 wherein the distal portion of the instrument selectively assumes a second shape when the instrument is advanced along the guide.

64. The method of claim 57 wherein maintaining the position of the guide comprises rigidizing the guide such that the guide rigidly assumes a position of the selected shape.

65. The method of claim 64 wherein rigidizing the guide comprises applying tension to a tensioning member disposed within the guide such that a plurality of adjacent segments comprising the guide are compressed.

66. The method of claim 64 wherein rigidizing the guide comprises applying a compressive force to an exterior of the elongate guide such that a plurality of adjacent segments comprising the guide are compressed.

67. An apparatus for insertion into a body cavity, comprising:

an elongate body having a selectively steerable distal portion, a controllable portion located proximally of the distal portion, and a lumen defined therebetween, the steerable distal portion being configurable to assume a selected shape along an arbitrary path;

an elongate guide having a proximal section, a distal section, and a length therebetween, the guide being slidably disposed without constraint over the elongate body to selectively support the elongate body,

wherein the guide is configured to conform to and selectively maintain the selected shape assumed by the steerable distal portion, and wherein the controllable portion of the elongate body when advanced distally is configured to propogate the selected shape to the contollable portion and conform to the selected curve maintained by the guide.

68. The apparatus of claim 67 wherein the selectively steerable distal portion is configurable via a control located externally of the body cavity.

69. The apparatus of claim 67 wherein the proximal section comprises a flexible tubular member.

70. The apparatus of claim 69 wherein the elongate guide comprises a plurality of pivotally connected segments.

71. The apparatus of claim 67 wherein the elongate guide is configured to assume the selected shape when the guide is in a flexible state and wherein the guide is further configured to maintain the selected shape when the guide is in a rigidized state.

72. The apparatus of claim 71 wherein the elongate guide is configured to selectively rigidize along the length of the guide to maintain the selected shape in the rigidized state.

73. The apparatus of claim 71 wherein the proximal section of the elongate guide is in communication with a guide controller for selectively rigidizing the guide along its length.

74. The apparatus of claim 71 wherein the elongate guide comprises a plurality of adjacent segments each defining a channel therethrough such that a common channel is defined through the length of the guide.

75. The apparatus of claim 74 further comprising a tensioning member slidably extending through the plurality of adjacent segments such that applying a force to the tensioning member compresses the adjacent segments together.

76. The apparatus of claim 74 wherein the elongate guide is configured to maintain a position of adjacent segments relative to each other upon applying a compressive force to an exterior of the plurality of adjacent segments.

77. The apparatus of claim 76 further comprising an expandable balloon.

78. The apparatus of claim 67 further comprising a tubular covering disposed over at least a majority of the length of the elongate guide.

79. An apparatus for insertion into a body cavity, comprising:

an elongate body having a proximal portion, a selectively steerable distal portion, and a lumen defined therebetween, the steerable distal portion being configurable to assume a selected shape along an arbitrary path;

an elongate guide having a proximal section, a distal section, and a length therebetween, the proximal section comprising a flexible tubular member, the guide comprising a plurality of pivotally connected segments and being slidably disposed without constraint over the elongate body to selectively support the elongate body,

wherein the guide is configured to conform to and selectively maintain the selected shape assumed by the steerable distal portion, and wherein the proximal portion of the elongate body when advanced distally is configured to conform to the selected curve maintained by the guide.

80. The apparatus of claim 79 further comprising a controllable portion located proximally of the distal portion, wherein the controllable portion is configured to propagate the selected shape to the controllable portion.

81. The apparatus of claim 80 wherein the selectively steerable distal portion is configurable via a control located externally of the body cavity.

82. The apparatus of claim 79 wherein the elongate guide is configured to assume the selected shape when the guide is in a flexible state and wherein the guide is further configured to maintain the selected shape when the guide is in a rigidized state.

83. The apparatus of claim 82 wherein the elongate guide is configured to selectively rigidize along the length of the guide to maintain the selected shape in the rigidized state.

84. The apparatus of claim 82 wherein the proximal section of the elongate guide is in communication with a guide controller for selectively rigidizing the guide along its length.

85. The apparatus of claim 82 wherein the plurality of pivotally connected segments of the elongate guide further comprises a plurality of adjacent segments each defining a channel through the guide such that a common channel is defined through the length of the guide.

86. The apparatus of claim 85 further comprising a tensioning member slidably extending through the plurality of adjacent segments such that applying a force to the tensioning member compresses the adjacent segments together.

87. The apparatus of claim 85 wherein the elongate guide is configured to maintain a position of adjacent segments relative to each other upon applying a compressive force to an exterior of the plurality of adjacent segments.

88. The apparatus of claim 87 further comprising an expandable balloon.

89. The apparatus of claim 79 further comprising a tubular covering disposed over at least a majority of the length of the elongate guide.

90. A method of advancing an instrument along an arbitrary path, comprising:

selectively steering a distal portion of the instrument to assume a selected shape along an arbitrary path;

advancing an elongate guide along the instrument by passing the instrument through a lumen within the elongate guide, such that a portion of the guide conforms to and assumes the selected shape; and

maintaining a position of the guide while advancing the instrument along the guide such that a proximal portion of the instrument assumes the selected shape defined by the guide,

wherein the elongate guide is freely slidable along the instrument such that advancing of the instrument along the guide is unconstrained.

91. The method of claim 90 wherein, prior to advancing the elongate guide along the instrument, further comprising advancing the instrument distally while configuring a controllable portion of the instrument to assume the selected shape of the distal portion, wherein the controllable portion is proximal of the distal portion.

92. The method of claim 90 further comprising measuring a depth change of the instrument while advancing the instrument distally.

93. The method of claim 92 further comprising incrementing a current depth by the depth change.

94. The method of claim 90 further comprising releasing the position of the guide and further advancing the guide along the instrument.

95. The method of claim 90 further comprising withdrawing the guide from the instrument.

96. The method of claim 90 wherein the distal portion of the instrument selectively assumes a second shape when the instrument is advanced along the guide.

97. The method of claim 90 wherein maintaining the position of the guide comprises rigidizing the guide such that the guide rigidly assumes a position of the selected shape.

98. The method of claim 97 wherein rigidizing the guide comprises applying tension to a tensioning member disposed within the guide such that a plurality of adjacent segments comprising the guide are compressed.

99. The method of claim 97 wherein rigidizing the guide comprises applying a compressive force to an exterior of the elongate guide such that a plurality of adjacent segments comprising the guide are compressed.