Self-activating endoluminal device

• US 20050113862A1
• Filed: 10/27/2004
• Published: 05/26/2005
• Est. Priority Date: 10/27/2003
• Status: Active Grant

• Current Assignee: Petrus Besselink
• Original Assignee: Hans Hanssen, Petrus A. Besselink, Wouter Markus
• Inventors: Markus, Wouter, Hanssen, Hans, Besselink, Petrus A.
• Granted Patent: US 7,776,062 B2
• Time in Patent Office: Days
• US Class Current: 606/200
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/0046 with a releasable handle; with handle and operating part separable
• CPC Class Codes: A61B 2017/22047 Means for immobilising the guide wire in the patient
• CPC Class Codes: A61F 2/011 Instruments for their placement or removal
• CPC Class Codes: A61F 2/013 Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2025/09141 made of shape memory alloys which take a particular shape at a certain temperature
• CPC Class Codes: A61M 25/0138 having flexible regions as a result of weakened outer material, e.g. slots, slits, cuts, joints or coils
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 25/09 Guide wires
• CPC Class Codes: A61M 25/09025 with sliding mandrils
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

An improved endoluminal device. The device includes at least a control element (such as a guide wire) connected to a surrounding sheath and an elastic bias section to control changes to a bias force formed between the control element and the sheath. By applying an external force at a proximal end of the device, the shape can change between varying degrees of deformed shapes and an undeformed shape. In this way, both ease of insertion into the body lumen and anchoring to the lumen is promoted. A distal end of the assembly can be made to change shape for improved steerability, anchoring or both. In a particular form, the anchoring section can work as a floating parachute-like device to pull the assembly by means of the flow in the body lumen, while in a more particular form, the floating parachute-like device may be modified to act as a filter for trapping emboli.

Claims

1. A medical device for use in a body lumen, said device comprising:

a tubular sheath comprising;

a proximal end;

a distal end opposite said proximal end;

at least one reconfigurable section disposed intermediate said proximal and distal ends; and

an elastic bias section disposed proximal relative to said reconfigurable section, said elastic bias section configured to vary the axial length of said reconfigurable section; and

an elongate control element defining a proximal end and a distal end, said control element sized to allow longitudinal placement thereof within said sheath, said sheath and control element fixedly attached to one another such that a tensile force is imposed by said sheath on said control element, said tensile force sufficient to bias said medical device in a deformed first shape that can be changed by variation of said tensile force through said elastic bias section such that said medical device assumes a second shape different from said first shape.

2. The device of claim 1, wherein said control element comprises a wire.

3. The device of claim 2, wherein the distal end of said wire is fixedly attached to the corresponding distal end of said sheath, and the proximal end of said wire is fixedly attached to the corresponding proximal end of said sheath while said elastic bias section is in an axially compressed state, thereby effecting said tensile force upon said wire.

4. The device of claim 3, further comprising a tool coupled to at least one of said wire or said sheath, said tool configured to regulate relative axial positions between said wire and said sheath and thereby effect transition between said first shape and said second shape.

5. The device of claim 4, wherein said tool comprises indicia configured to apprise a user of an amount of bias extant in said elastic bias section.

6. The device of claim 4, wherein said tool comprises indicia configured to apprise a user of an amount of deformation extant in said second shape.

7. The device of claim 4, wherein said tool comprises a connector to facilitate removable attachment of said tool to said at least one of said wire or said sheath.

8. The device of claim 7, wherein said connector comprises a lock.

9. The device of claim 8, wherein said lock comprises a threaded connection between said tool and said sheath.

10. The device of claim 1, where said reconfigurable section comprises a steerable section disposed adjacent said distal end of said sheath.

11. The device of claim 10, wherein said first shape comprises a bend in at least a portion of said steerable section.

12. The device of claim 10, wherein said steerable section defines at least one slot formed in said sheath.

13. The device of claim 12, wherein said at least one slot defines at least one of an axial, tangential or circumferential slot.

14. The device of claim 13, wherein angles defining said at least one slot comprise a plurality of different angles, all oriented between 0 and 90 degrees with the longitudinal axis of said sheath.

15. The device of claim 11, wherein said steerable section comprises a plurality of steerable regions within said reconfigurable section.

16. The device of claim 15, wherein said bends formed in each of said plurality of steerable regions are biased in directions independent of the remainder of said plurality of steerable regions.

17. The device of claim 15, wherein said first shape comprises a bend in a plurality of said plurality of steerable regions.

18. The device of claim 10, wherein said steerable section comprises a coil spring disposed in said sheath.

19. The device of claim 18, further comprising a rigidity element disposed asymmetrically in said coil spring to define a preferential direction of said bend.

20. The device of claim 10, wherein said steerable section further comprises a longitudinal reinforcement disposed asymmetrically along the outer surface of said sheath.

21. The device of claim 1, where said reconfigurable section of said sheath comprises an anchoring section configured to assume an expanded state when said medical device is in said first shape and an unexpanded or less expanded state when said medical device is in said second shape.

22. The device of claim 21, whereupon said expanded state comprises a substantially radially expanded state.

23. The device of claim 21, whereupon said expanded state comprises a substantially helical shape.

24. The device of claim 21, wherein said anchoring section comprises a mesh layer configured as a collapsible basket.

25. The device of claim 21, wherein said anchoring section comprises a plurality of struts with slots defined therebetween.

26. The device of claim 25, wherein said plurality of struts are oriented along a substantially axial dimension of said sheath.

27. The device of claim 25, wherein said anchoring section comprises a wire mesh disposed over said struts.

28. The device of claim 25, wherein said anchoring section further comprises a flexible layer disposed over said struts.

29. The device of claim 28, wherein said flexible layer comprises a polymer material.

30. The device of claim 29, wherein said polymer layer is configured as a filter, said filter defining a plurality of perforations within its surface.

31. The device of claim 29, wherein said flexible polymer layer is configured as a bag with an open proximal entrance mouth and a closed distal end.

32. The device of claim 31, wherein the proximal entrance mouth of said bag is coupled to said struts at a distal location relative to a largest diameter defined by said struts in said expanded state.

33. The device of claim 1, where said reconfigurable section of said sheath comprises a steerable section and an anchoring section, said steerable section distally disposed relative to said anchoring section.

34. The device of claim 33, wherein at least one of said steerable and anchoring sections is elastically deformable in response to said variation of said tensile force.

35. The device of claim 1, further comprising an endoluminal device configured to slidably fit over said sheath.

36. The device of claim 35, wherein said endoluminal device is selected from the group consisting of a catheter, steerable tip, stent, filter, angioplasty balloon, drain, dilator, filter, basket, anchor, floating anchor, occlusion device, guide wire, stylet, electrode, lead, drain, catheter sheath for use with catheter introducers or a drug infusion catheter, and combinations thereof.

37. The device of claim 1, wherein said device is selected from the group consisting of a catheter, steerable tip, stent, filter, angioplasty balloon, drain, dilator, filter, basket, anchor, floating anchor, occlusion device, guide wire, stylet, electrode, lead, drain, catheter sheath for use with catheter introducers or a drug infusion catheter, and combinations thereof.

38. The device of claim 1, wherein materials making up said control element are selected from the group consisting of polymers, metals and combinations thereof.

39. The device of claim 38, wherein said metal is a shape-memory metal.

40. The device of claim 1, wherein materials making up said sheath are selected from the group consisting of polymers, metals and combinations thereof.

41. The device of claim 40, wherein at least a portion of said reconfigurable section comprises a shape-memory metal.

42. The device of claim 1, wherein said variation of said tensile force comprises a reduction in said tensile force.

43. The device of claim 1, wherein said second shape is a substantially undeformed shape.

44. The device of claim 1, wherein said second shape is a partially deformed shape.

45. A guide wire assembly for use in a body lumen, said assembly comprising:

a tubular sheath defining a proximal end, a distal end and at least one reconfigurable section disposed intermediate said proximal and distal ends;

a wire defining a proximal end and a distal end, said proximal and distal ends of said wire placed substantially adjacent to and substantially aligned with respective said ends of said sheath to facilitate a fixed attachment therebetween such that a force imposed by said sheath on said wire is sufficient to bias said assembly in a deformed first shape; and

an elastic bias section cooperative with said sheath and configured to vary said force such that upon application of said variation in said force, said assembly assumes a second shape different from said first shape.

46. The assembly of claim 45, further comprising a tool coupled to said elastic bias section to control said variation in said force between said sheath and said wire.

47. The assembly of claim 45, wherein said at least one reconfigurable section comprises a steerable section disposed adjacent said distal end of said assembly, said steerable section bendably responsive to said variation in said force.

48. The assembly of claim 47, wherein said at least one reconfigurable section further comprises an anchoring section expandably responsive to said variation in said force.

49. The assembly of claim 45, wherein said at least one reconfigurable section comprises an anchoring section expandably responsive to said variation in said force.

50. The assembly of claim 49, wherein said anchoring section is configured to assume a substantially expanded state when said assembly is in said first shape, and a reduction in said expanded state when said assembly is in said second shape.

51. The assembly of claim 50, wherein said reduction in said expanded state comprises an unexpanded state.

52. The assembly of claim 45, wherein said elastic bias section is formed in said sheath.

53. A medical device comprising:

a hollow elongate member; and

an elongate control element sized to freely move longitudinally in said hollow elongate member, wherein said hollow elongate member and said elongate control element are fixedly attached to each other at respective proximal ends and distal ends such that when separately measured in an undeformed state between said proximal and distal ends, said elongate control element is shorter than said hollow elongate member.

54. The device of claim 53, where said hollow elongate member is provided with at least two sections that can be elastically deformed in a longitudinal direction, said at least two sections comprising:

an elastic bias section located adjacent said proximal end of said elongate member; and

a reconfigurable section located intermediate said proximal and distal ends of said elongate member, said reconfigurable section cooperative with said elastic bias section such that relative movements between said elongate control element and said elongate member produce a change in shape of said reconfigurable section.

55. The device of claim 54, wherein a biasing force caused by stored energy in said elastic bias section is sufficient to bring said reconfigurable section into a deformed shape.

56. The device of claim 54, further comprising a removable tool for length control and consequent change in shape of said reconfigurable section.

57. The device of claim 56, wherein said change in shape of said reconfigurable section comprises a change into a state that is suitable for inserting into and removable from a body lumen.

58. The device of claim 56, wherein the tool cooperates with said elastic bias section to produce intermediate positions for said reconfigurable section.

59. The device of claim 54, wherein said reconfigurable section comprises:

a plurality of steerable sections, each of said plurality of steerable sections responsive to different levels in force between said elongate member and said control element; and

an expandable anchoring section responsive to changes in force between said elongate member and said control element.

60. The device of claim 59, wherein at least one of said plurality of steerable sections defines a pattern of slots formed in a wall of said elongate member.

61. The device of claim 59, wherein at least one of said plurality of steerable sections comprises an additional asymmetric reinforcing element.

62. The device of claim 61, wherein said asymmetric reinforcing element is disposed on the outer surface of said elongate member.

63. The device of claim 59, wherein said anchoring section comprises:

a basket comprising a plurality of struts configured to facilitate changes of shape between a first deformed shape and a second shape; and

a flexible polymer layer disposed over at least a portion of said basket, said layer defining an open proximal entrance mouth.

64. The device of claim 63, wherein said proximal entrance mouth is located distal of a radially widest portion of said basket.

65. The device of claim 64, wherein said polymer layer is configured as a bag, said bag configured to form a pressure difference between proximal and distal sides of said bag.

66. The device of claim 65, wherein said bag is used to at least partly occlude a body lumen.

67. The device of claim 63, wherein said polymer layer defines apertures in a surface thereof.

68. The device of claim 67, wherein said polymer layer is configured as a bag coupled to said anchoring section, said bag adapted for use as a filter for catching debris that pass through said body lumen.

69. The device of claim 56, whereupon removal of said tool, said reconfigurable section is configured to remain in said body lumen.

70. The device of claim 69, further comprising a treatment device configured to be deployed inside said body lumen over said proximal end of said elongate member while said reconfigurable section remains in said body lumen.

71. The device of claim 70, wherein said treatment device is selected from the group consisting of a catheter, stent, filter, angioplasty balloon, drain, dilator, filter, basket, anchor, floating anchor, occlusion device, guide wire, stylet, electrode, lead, drain, catheter sheath for use with catheter introducers or a drug infusion catheter, and combinations thereof.

72. The device of claim 71, wherein said tool is applied to control the geometry of said reconfigurable section while either or both of said device and said treatment device are moved through or positioned in said body lumen.

73. The device of claim 71, wherein said tool comprises a display configured to inform an operator about an operational status of said reconfigurable section.

74. The device of claim 53, wherein materials making up said elongate member and said control element are selected from the group consisting of polymers, metals, metals with enhanced radio-opacity features and combinations thereof.

75. The device of claim 74, wherein said control element may be made from a different material than said elongate member.

76. The medical device of claim 53, wherein the length difference of said elongate member and said control element can be adjusted at or near a proximal fixation end of said device by a releasable locking means.

77. A method of inserting a medical device into a body lumen, said method comprising:

configuring said device to comprise;

a tubular sheath defining a proximal end, a distal end, at least one reconfigurable section disposed intermediate said proximal and distal ends, and an elastic bias section disposed proximal relative to said reconfigurable section, said elastic bias section configured to vary the axial length of said reconfigurable section; and

an elongate control element defining a proximal end and a distal end, said sheath and control element attached to one another such that a bias force exists between said sheath and said control element, said bias force sufficient to keep said device in a deformed first shape;

introducing said device into said lumen; and

imposing a force on said device to change said bias force, thereby causing said medical device to assume a second shape different from said first shape.

78. The method of claim 77, wherein said imposing a force on said device comprises imposing a force on a proximal end of said device.

79. The method of claim 78, further comprising configuring said device to comprise a tool coupled to said proximal end of said device such that said imposing a force on said device is effected through said tool.

80. The method of claim 77, wherein said imposing a force on said device comprises reducing a tensile force on said control element.

81. The method of claim 77, further comprising monitoring indicia configured to register relative displacement between said sheath and said control element.

82. The method of claim 77, wherein said reconfigurable section in said sheath comprises a steerable section.

83. The method of claim 77, wherein said steerable section comprises a plurality of steerable regions.

84. The method of claim 83, wherein at least two of said plurality of steerable regions are configured to deform in a substantially similar direction upon said imposing a force on said device to change said bias force.

85. The method of claim 83, wherein at least one of said plurality of steerable regions is configured to deform in a substantially different direction upon said imposing a force on said device to change said bias force.

86. The method of claim 82, wherein said second shape comprises a bend in said steerable section.

87. The method of claim 82, further comprising forming at least one place of weakness in said steerable section to establish at least one preferential direction for promoting said first shape.

88. The method of claim 87, wherein said at least one place of weakness comprises at least one slot defined in said sheath.

89. The method of claim 82, wherein said steerable section comprises a coil spring disposed in said sheath.

90. The method of claim 89, further comprising a rigidity element disposed asymmetrically in said coil spring to establish at least one preferential direction for promoting said first shape.

91. The method of claim 82, wherein said steerable section comprises a longitudinal reinforcement disposed asymmetrically along the outer surface of said sheath.

92. The method of claim 77, wherein said reconfigurable section comprises an anchoring section.

93. The method of claim 92, further comprising coupling a mesh layer to said anchoring section.

94. The method of claim 92, wherein said anchoring section comprises a mesh layer configured as a collapsible basket.

95. The method of claim 92, wherein said first shape comprises an expansion in said anchoring section.

96. The method of claim 95, wherein said expansion in said anchoring section is configured to expand to a radial dimension sufficient to contact an interior wall of said lumen.

97. The method of claim 95, wherein said anchoring section is configured to assume a radial dimension less than that sufficient to contact an interior wall of said lumen but more than a substantially undeformed shape.

98. The method of claim 92, further comprising coupling a polymer layer to said anchoring section.

99. The method of claim 98, wherein said polymer layer comprises a bag comprising an opening at a proximal end and a closed distal end.

100. The method of claim 99, wherein said bag defines a plurality of apertures formed therein.

101. The method of claim 100, further comprising filtering a fluid through said bag.

102. The method of claim 99, further comprising partially expanding said anchoring section, and flowing a fluid through said bag to facilitate downstream movement of said device.

103. The method of claim 77, wherein said reconfigurable section comprises an anchoring section and a steerable section.

104. The method of claim 103, wherein said anchoring section is disposed on a proximal portion of said device relative to said steerable section.

105. The method of claim 103, further comprising configuring said device to comprise a tool coupled to said proximal end of said device to effect transition between said first shape and said second shape in at least one of said steerable section and said anchoring section.

106. The method of claim 103, wherein said anchoring section assumes a helical shape upon the presence of said bias force.

107. The method of claim 103, wherein said steerable section is cooperative with said anchoring section such that both assume a helical shape upon the presence of said bias force.

108. The method of claim 103, wherein said imposing a force in said device comprises reducing a tensile force on said control element such that said anchoring section transitions from said first shape to said second shape prior to said steerable section transitioning from said first shape to said second shape.