Methods and apparatuses for positioning within an internal channel

• US 20060135870A1
• Filed: 12/20/2004
• Published: 06/22/2006
• Est. Priority Date: 12/20/2004
• Status: Active Grant

• Current Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Inventors: Webler, William E.
• Granted Patent: US 8,983,582 B2
• Time in Patent Office: Days
• US Class Current: 600/431
• CPC Class Codes: A61B 1/00096 Optical elements
• CPC Class Codes: A61B 1/00183 for variable viewing angles
• CPC Class Codes: A61B 1/0051 with controlled bending of insertion part
• CPC Class Codes: A61B 1/3137 for examination of the interior of blood vessels
• CPC Class Codes: A61B 2017/22081 Treatment of vulnerable plaque
• CPC Class Codes: A61B 2090/3735 Optical coherence tomography [OCT]
• CPC Class Codes: A61B 5/0036 including treatment, e.g., using an implantable medical device, ablating, ventilating
• CPC Class Codes: A61B 5/0062 Arrangements for scanning
• CPC Class Codes: A61B 5/0066 Optical coherence imaging
• CPC Class Codes: A61B 5/0084 for introduction into the body, e.g. by catheters A61B5/1459 takes precedence
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/02007 Evaluating blood vessel condition, e.g. elasticity, compliance
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/6851 Guide wires
• CPC Class Codes: A61B 5/6852 Catheters
• CPC Class Codes: A61B 5/6853 with a balloon
• CPC Class Codes: A61B 5/6857 with a distal pigtail shape
• CPC Class Codes: A61B 5/6885 Monitoring or controlling sensor contact pressure
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61N 2005/0602 for treatment of blood vessels
• CPC Class Codes: A61N 5/0601 : Apparatus for use inside the body
• CPC Class Codes: A61N 5/062 : Photodynamic therapy, i.e. excitation of an agent

Abstract

Methods and apparatuses for positioning medical devices onto (or close to) a desired portion of the interior wall of an internal channel, such as for scan imaging, for photodynamic therapy and/or for optical temperature measurement. In one embodiment, a catheter assembly has a distal portion that can be changed from a configuration suitable for traversing the internal channel to another configuration suitable for scan at least a spiral section of the interior wall of an internal channel, such as an artery. In one example, the distal portion spirals into gentle contact with (or close to) a spiral section of the artery wall for Optical Coherence Tomography (OCT) scanning. The spiral radius may be changed through the use of a guidewire, a tendon, a spiral balloon, a tube, or other ways.

Claims

1. An elongated assembly, comprising:

a proximal portion; and

a distal portion, the distal portion to be inserted into a vessel, the distal portion controllable through the proximal portion, the distal portion comprising;

an elongated sheath, the elongated sheath to house a core movable along the sheath; and

a guide structure coupled with the elongated sheath, the guide structure being controllable through the proximal portion to increase an overall diameter of the distal portion from a first overall diameter of a first configuration to a second overall diameter of a second configuration, in the second configuration the elongated sheath having a substantially spiral shape.

2. The assembly of claim 1, wherein the core is to detect a chemical and the elongated sheath is permeable to the chemical.

3. The assembly of claim 1, wherein the core includes a temperature sensor.

4. The assembly of claim 1, wherein the core is capable of at least one of:

projecting an optical beam onto a portion of the vessel and receiving a light from a portion of the vessel.

5. The assembly of claim 1, wherein the elongated sheath has at least a portion that is transparent or translucent to allow passage of light between the core and a spiral path on the vessel as the core moves within the elongated sheath.

6. The assembly of claim 4, wherein in the second configuration light blockage due to blood in the vessel between outside of the spiral shape of the elongated sheath and the vessel is smaller than in the first configuration.

7. The assembly of claim 6, wherein the distal portion is to traverse the vessel in the first configuration;

the core is to move along the elongated sheath to scan the vessel in the second configuration with reduced light blockage.

8. The assembly of claim 6, wherein in the second configuration the distal portion does not severely block a flow of the blood in the vessel.

9. The assembly of claim 8, wherein in the second configuration the distal portion does not block a flow of the blood in the vessel significantly more than in the first configuration.

10. The assembly of claim 4, further comprising:

the core housed within the elongated sheath, the core to project an optical beam and to receive a reflected light for optical coherence tomography;

wherein the core is movable along the elongated sheath to scan a portion of the vessel.

11. The assembly of claim 10, wherein, when the elongated sheath is in the substantially spiral shape:

movement of the core along the elongated sheath does not change the substantially spiral shape of the elongated sheath; and

the core is capable to scan the vessel along a spiral path on the vessel.

12. The assembly of claim 10, wherein the optical beam comprises a short coherence length light.

13. The assembly of claim 12, wherein a pitch length of the spiral shape is less than five times an imaging depth of the core.

14. The assembly of claim 12, wherein a pitch length of the spiral shape is less than a size of a significant vulnerable plaque on a blood vessel plus two times an imaging depth of the core.

15. The assembly of claim 4, wherein in the second configuration a diameter of the spiral shape is substantially equal to a diameter of the vessel.

16. The assembly of claim 4, wherein the distal portion has a stiffness to be of a spiral shape in absence of external constrains;

wherein a straight guidewire is insertable into the distal portion to straighten the distal portion into the first configuration.

17. The assembly of claim 16, wherein the straight guidewire is insertable into the elongated sheath in the distal portion to straighten the distal portion into the first configuration.

18. The assembly of claim 4, wherein the guide structure has a guidewire lumen;

the assembly further comprises;

a guidewire, a segment of the guidewire being operable through the proximal portion to slide within the guidewire lumen,

the segment of the guidewire having a stiffness to be substantially straight in absence of external constraints,

the distal portion having a stiffness to be of a spiral shape in absence of external constrains,

the distal portion being in the first configuration when the segment of the guidewire is in the guidewire lumen to straighten the distal portion,

the distal portion being in the second configuration when the segment of the guidewire is out of the guidewire lumen.

19. The assembly of claim 18, wherein the elongated sheath is substantially straight when in the first configuration;

and a radius of the spiral shape of the elongated sheath is substantially equal to a radius of the vessel when in the second configuration and in the vessel.

20. The assembly of claim 4, wherein the distal portion has a stiffness to be substantially straight in absence of external constrains;

wherein a spiral guidewire is insertable into the distal portion to spiral the distal portion into the second configuration.

21. The assembly of claim 4, wherein the guide structure has a guidewire lumen;

the assembly further comprises;

a guidewire, a segment of the guidewire being operable through the proximal portion to slide within the guidewire lumen,

the segment of the guidewire having a stiffness to be in a spiral shape in absence of external constraints,

the distal portion having a stiffness to be substantially straight in absence of external constrains,

the distal portion being in the first configuration when the segment of the guidewire is out of the guidewire lumen,

the distal portion being in the second configuration when the segment of the guidewire is in the guidewire lumen to spiral the distal portion.

22. The assembly of claim 21, wherein the elongated sheath is substantially straight when in the first configuration;

and a radius of the spiral shape is substantially equal to a radius of the vessel when in the second configuration and in the vessel.

23. The assembly of claim 21, wherein the assembly has a middle portion connected to the distal portion, the middle portion having a stiffness to be substantially straight in absence of external constraints, the middle portion to remain substantially straight when the segment of the guidewire is in the middle portion.

24. The assembly of claim 4, wherein the guide structure is operable at the proximal portion to:

reduce a spiral length of the elongated sheath to increase a spiral diameter of the elongated sheath; and

increase the spiral length of the elongated sheath to reduce the spiral diameter of the elongated sheath.

25. The assembly of claim 4, wherein the guide structure is operable at the proximal portion to:

reduce a number of spiral turns of the elongated sheath to increase a spiral diameter of the elongated sheath; and

increase a number of spiral turns of the elongated sheath to reduce the spiral diameter of the elongated sheath.

26. The assembly of claim 4, wherein the guide structure comprises:

a tube; and

a guide member, the guide member being substantially straight, a portion of the guide member slidable into the tube,

the guide member having a distal end extending outside the tube,

the elongated sheath having a distal end coupled to the distal end of the guide member,

the elongated sheath having a proximal end coupled to the tube,

the elongated sheath spiraling around the guide member,

the elongated sheath wrapping against the guide member in the first configuration when the portion of the guide member is out of the tube,

the elongated sheath spiraling against the vessel in the second configuration when the portion of the guide member is in the tube.

27. The assembly of claim 26, wherein the guide member and the tube are rotatable with respect to each other;

when the guide member and the tube rotate with respect to each other in a first direction, a diameter of the spiral shape of the elongated sheath is increased;

when the guide member and the tube rotate with respect to each other in a second direction, the diameter of the spiral shape of the elongated sheath is decreased.

28. The assembly of claim 4, wherein the guide structure comprises:

a guide member; and

a tendon coupled to the guide member, the tendon bending the guide member into a spiral in the second configuration when the tendon is in tension, the guide member having a stiffness to be substantially straight in the first configuration when the tendon is not in tension.

29. The assembly of claim 28, wherein the guide member is insertable into the elongated sheath in the distal portion to straighten the distal portion into the first configuration.

30. The assembly of claim 28, wherein the guide member has a tendon lumen spiraling around the guide member to house the tendon.

31. The assembly of claim 30, wherein the elongated sheath spirals around the guide member on an opposite side of the tendon lumen.

32. The assembly of claim 28, wherein the assembly has a middle portion connected to the distal portion, the middle portion comprises a plurality of tendons, the plurality of tendons in the middle portion connected to the tendon in the distal portion to provide a tension force to bend the guide member.

33. The assembly of claim 32, wherein the tension force is distributed in the plurality of tendons in the middle portion to reduce bending moment to the middle portion due to the tension force.

34. The assembly of claim 4, wherein the guide structure comprises:

a guide member, the guide member being substantially straight; and

a balloon outside the guide member, the elongated sheath spiraling over the balloon, a spiral diameter of the elongated sheath increasing in the second configuration when the balloon is inflated, the spiral diameter of the elongated sheath decreasing in the first configuration when the balloon is deflated.

35. The assembly of claim 4, wherein the guide structure comprises:

a guide member, the guide member being capable of being substantially straight; and

a spiral balloon, the spiral balloon spiraling around the guide member, the elongated sheath spiraling over the spiral balloon, a spiral diameter of the elongated sheath increasing in the second configuration when the spiral balloon is inflated, the spiral diameter of the elongated sheath decreasing in the first configuration when the spiral balloon is deflated.

36. The assembly of claim 4, wherein the guide structure comprises:

a guide member, the guide member being substantially straight, the elongated sheath spiraling around the guide member; and

a balloon, the balloon containing the elongated sheath, the distal portion being in the first configuration when the balloon is deflated, the distal portion being in the second configuration when the balloon is inflated.

37. The assembly of claim 36, wherein the balloon comprises a spiral balloon.

38. An assembly, comprising:

a sheath having a spiral shape to be disposed along a vessel, the sheath to house a core capable of at least one of;

projecting an optical beam onto a portion of the vessel and receiving a light from a portion of the vessel, the core being movable along the sheath to scan at least a spiral portion of the vessel.

39. The assembly of claim 38, wherein the sheath has a guide member lumen;

and a diameter of the spiral shape is substantially equal to the diameter of the vessel.

40. The assembly of claim 39, wherein the sheath is capable of being straightened in the vessel when a guide member is inserted into the guide member lumen.

41. The assembly of claim 39, wherein the sheath is capable of being shaped into the spiral shape in the vessel when a spiral guidewire is inserted into the guide member lumen.

42. The assembly of claim 38, further comprising:

a guide member, the sheath spiraling around the guide member, the sheath having a distal end coupled to the guide member.

43. The assembly of claim 42, wherein the sheath has a proximal end movable along the guide member toward the distal end to increase a spiral diameter of the sheath and away from the distal end to decrease the spiral diameter of the sheath.

44. The assembly of claim 42, wherein the sheath has a proximal end movable around the guide member in a first direction to increase a spiral diameter of the sheath and in a second direction to decrease the spiral diameter of the sheath.

45. The assembly of claim 42, further comprising:

a tube, the tube and the guide member rotatable and slidable with respect to each other, the sheath has a proximal end attached to the tube.

46. The assembly of claim 42, wherein the guide member has a tendon lumen spiraling around the guide member;

the assembly further comprises;

a tendon housed inside the tendon lumen, the tendon having a distal end attached to the guide member, the tendon to bend the guide member into a spiral shape when the tendon is in tension, the guide member being substantially straight when the tendon is not in tension.

47. The assembly of claim 38, further comprising:

a balloon within the spiral shape of the sheath, the balloon being inflatable to increase a radius of the spiral shape of the sheath, the balloon being deflatable to decrease the radius of the spiral shape of the sheath.

48. The assembly of claim 47, further comprising:

a substantially straight guide member, the balloon being outside the guide member.

49. The assembly of claim 47, wherein the balloon is of a spiral shape.

50. The assembly of claim 38, further comprising:

a substantially straight guide member, the sheath spiraling around the guide member; and

a balloon mounted to enclose the sheath.

51. The assembly of claim 50, wherein the balloon is of a spiral shape.

52. An assembly to be inserted into a vessel, the assembly comprising:

a sheath, the sheath to house a core capable of at least one of;

projecting a light onto a portion of the vessel and receiving a light from a portion of the vessel, the core being movable along the sheath to scan at least a portion of a vessel; and

a balloon coupled to at least a portion of the sheath along the sheath, when inflated the balloon to clear or reduce at least a portion of a light path between the sheath and the vessel to reduce light blockage.

53. The assembly of claim 52, wherein the balloon is of a spiral shape, spiraling around the sheath.

54. The assembly of claim 53, wherein the core to project an optical beam and to receive a reflected light for optical coherence tomography;

and the balloon is substantially transparent to the optical beam.

55. The assembly of claim 53, wherein the balloon is at least one of:

slidable along the sheath; and

rotatable about the sheath.

56. The assembly of claim 53, wherein the sheath has a stiffness to remain substantially straight when the balloon of the spiral shape is inflated.

57. An assembly to be inserted into a vessel, the assembly comprising:

a plurality of spiral sheaths twisted together, the spiral sheaths to house one or more cores capable of at least one of;

projecting a light onto a portion of the vessel and receiving a light from a portion of the vessel.

58. The assembly of claim 57, further comprising:

a guide member, the guide member having a distal end, each of the spiral sheaths having a distal end coupled to the distal end of the guide member; and

a tube, the tube and the guide member rotatable and slidable with respect to each other, the tube having a distal end, each of the spiral sheaths having a proximal end coupled to the tube.

59. The assembly of claim 58, wherein a core is insertable from the tube into each of the plurality of spiral sheaths.

60. The assembly of claim 57, wherein each of the plurality of spiral sheaths houses an individual core.

61. A method to operate an assembly, the method comprising:

inserting a distal portion of the assembly into a vessel, the distal portion of the assembly having a sheath to house a core capable of at least one of;

projecting a light onto a portion of the vessel and receiving a light from a portion of the vessel; and

operating at a proximal portion of the assembly to expand a spiral radius of the sheath in the vessel.

62. The method of claim 61, further comprising:

moving the core along the sheath to perform optical coherence tomography.

63. The method of claim 61, wherein said operating comprises:

moving a portion of a guidewire out of the distal portion of the assembly, the portion of the guidewire being substantially straight, the distal portion of the assembly being pre-shaped into a spiral in absence of the portion of the guidewire.

64. The method of claim 63, further comprising:

inserting the portion of the guidewire into the distal portion of the assembly to temporarily straighten the distal portion; and

repositioning the distal portion in the vessel while the guidewire is straightened.

65. The method of claim 61, wherein said operating comprises:

inserting a portion of a guidewire into the distal portion of the assembly, the portion of the guidewire inserted into the distal portion being pre-shaped into a spiral, the distal portion of the assembly being substantially straight in absence of the guidewire, the portion of the guidewire inserted into the distal portion forcing the distal portion into a spiral shape.

66. The method of claim 63, further comprising:

moving the portion of the guidewire out of the distal portion of the assembly to allow the distal portion to recover back to a substantially straight shape; and

repositioning the distal portion in the vessel while the guidewire is in the substantially straight shape.

67. The method of claim 61, wherein said operating comprises:

pulling a guidewire to reduce a spiral distance of the sheath.

68. The method of claim 61, wherein the sheath has a distal end attached to a guide member and a proximal end attached to a tube, the guide member slidable into the tube, the sheath spiraling abound the guide member;

and

pulling the guidewire causes the guide member to slide into the tube to reduce the spiral distance of the sheath.

69. The method of claim 68, wherein said operating further comprises:

rotating the guide member and the tube with respect to each other to reduce a number of turns of the sheath.

70. The method of claim 69, wherein the guide member comprises a guidewire.

71. The method of claim 61, wherein said operating comprises:

pulling the guidewire to cause an tendon in the distal portion of the assembly to bend the distal portion into a spiral.

72. The method of claim 71, further comprising:

relaxing the guidewire to allow the distal portion of the assembly to recover back to a substantially straight shape.

73. The method of claim 61, wherein said operating comprises:

inflating a balloon of the distal portion of the assembly to expand the spiral radius of the sheath.

74. The method of claim 73, further comprising:

deflating the balloon of the distal portion of the assembly to reduce the spiral radius of the sheath;

repositioning the distal portion in the vessel while the spiral radius of the sheath is reduced.

75. A method of scanning a vessel wall, comprising:

slidably displacing a core in a longitudinally extending spiral pattern within an inner surface of the vessel wall, the core being capable of at least one of projecting and receiving light.

76. The method of claim 75, further comprising:

imaging the inner surface of the vessel wall for the presence of a diseased region;

wherein the core is slidable along a spiral member having an orthogonal distance between adjacent spiral loops which is shorter than a minimum length of diseased regions to be detected plus two times an effective imaging depth of the core.

77. The method of claim 75, further comprising:

changing a sheath from a first shape to a first spiral shape within the vessel wall;

wherein the core is slidable within the sheath to scan the vessel wall along a spiral path on the vessel wall when the sheath is in the spiral shape.

78. The method of claim 77, wherein the first shape is a second spiral shape having a spiral diameter smaller than a spiral diameter of the first spiral shape.

79. An assembly having a distal portion and a proximal portion, the distal portion to be inserted into a vessel, the distal portion controllable through operations on the proximal portion, the assembly comprising:

a sheath at the distal portion to house a core capable of at least one of;

projecting a light onto a portion of the vessel and receiving a light from a portion of the vessel; and

means for adjusting a shape of the sheath within the vessel through operations at the proximal portion.

80. The assembly of claim 79, wherein said means for adjusting is operable to reduce an overall radius of the sheath for the distal portion to traverse the vessel;

and said means for adjusting is operable to increase a spiral radius of the sheath to bring the sheath close to the vessel along a spiral.

81. The assembly of claim 80, wherein a pitch length of the spiral is less than ten times the radius of the vessel.

82. The assembly of claim 80, wherein said means for adjusting comprises a guidewire having a stiffness to temporarily shape the sheath.

83. The assembly of claim 80, wherein said means for adjusting comprises a guide member and a tube, the guide member slidable into the tube, the sheath having one end coupled to the guide member outside the tube and one end coupled to the tube.

84. The assembly of claim 80, wherein said means for adjusting comprises a tendon to bend the sheath.

85. The assembly of claim 80, wherein said means for adjusting comprises a balloon.

86. An assembly having a distal portion and a proximal portion, the distal portion to be inserted into a vessel, the distal portion controllable through operations on the proximal portion, the assembly comprising:

a sheath at the distal portion to house a core capable of at least one of;

projecting an optical beam onto a portion of the vessel and receiving a light from a portion of the vessel; and

a controller coupled to the sheath, the controller to adjust a shape of the sheath within the vessel through operations at the proximal portion.

87. The assembly of claim 86, wherein the controller is operable near the proximal portion to change a spiral radius of the sheath.

88. The assembly of claim 87, wherein the controller is operable near the proximal portion to change a spiral pitch length of the sheath.

89. The assembly of claim 87, wherein the controller comprisies:

a guide member; and

a tube, the guide member slidable into the tube, the sheath having one end coupled to the guide member outside the tube and one end coupled to the tube, the sheath to spiral outside the guide member.

90. The assembly of claim 87, wherein the controller comprises one of:

a tendon to bend the sheath;

a balloon; and

a guidewire having a stiffness to temporarily shape the sheath when a distal portion of the guidwire is inserted or withdrawn into the distal portion of the assembly.

91. An assembly to be inserted into a vessel, the assembly comprising:

a sheath, the sheath to house a core capable of at least one of;

projecting an optical beam onto a portion of the vessel and receiving a light from the portion of the vessel, the core being movable along the sheath to scan at least a portion of a vessel; and

a support coupled to at least a portion of the sheath, the support capable of changing shape to clear or reduce at least a portion of a signal path between the sheath and the vessel.

92. The assembly of claim 91, wherein the support comprises an inflatable balloon which has a spiral shape when inflated.

93. The assembly of claim 91, wherein the support comprises an elastic balloon which has a spiral shape when inflated.

94. The assembly of claim 91, wherein the core is to receive a light for an optical temperature measurement of the vessel.

95. The assembly of claim 91, wherein the core is to project a beam for a photodynamic therapy to the vessel.

96. The assembly of claim 91, wherein the core is to project a beam onto the vessel and receive a reflected light for Optical Coherence Tomography (OCT) scanning.