Tissue visualization and manipulation system

• US 7,860,555 B2
• Filed: 10/25/2005
• Issued: 12/28/2010
• Est. Priority Date: 02/02/2005
• Status: Active Grant

• Current Assignee: Intuitive Surgical Operations, Inc. (Intuitive Surgical Holdings, LLC)
• Original Assignee: Voyage Medical, Inc.
• Inventors: Saadat, Vahid
• Primary Examiner(s): Casler; Brian
• Assistant Examiner(s): KISH, JAMES M
• Application Number:
  US11/259,498
• Publication Number:
  US 20060184048A1
• Time in Patent Office: 1,890 Days
• Field of Search: 600/476, 600/478, 600/479, 600/101, 600/106, 600/109, 600/129
• US Class Current: 600/476
• CPC Class Codes: A61B 1/0008 characterised by distal tip features
• CPC Class Codes: A61B 1/00082 Balloons
• CPC Class Codes: A61B 1/00085 Baskets
• CPC Class Codes: A61B 1/00089 Hoods
• CPC Class Codes: A61B 1/00096 Optical elements
• CPC Class Codes: A61B 1/005 Flexible endoscopes
• CPC Class Codes: A61B 1/015 Control of fluid supply or evacuation
• CPC Class Codes: A61B 1/018 for receiving instruments
• CPC Class Codes: A61B 1/04 combined with photographic or television appliances
• CPC Class Codes: A61B 1/3137 for examination of the interior of blood vessels
• CPC Class Codes: A61B 2018/0212 using an instrument inserted into a body lumen, e.g. catheter
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/02007 Evaluating blood vessel condition, e.g. elasticity, compliance
• CPC Class Codes: A61B 5/6882 Anchoring means
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00

Abstract

Tissue visualization and manipulation systems are described herein. Such a system may include a deployment catheter and an attached imaging hood deployable into an expanded configuration. In use, the imaging hood is placed against or adjacent to a region of tissue to be imaged in a body lumen that is normally filled with an opaque bodily fluid such as blood. A translucent or transparent fluid, such as saline, can be pumped into the imaging hood until the fluid displaces any blood, thereby leaving a clear region of tissue to be imaged via an imaging element in the deployment catheter. Additionally, any number of therapeutic tools can also be passed through the deployment catheter and into the imaging hood for treating the tissue region of interest.

Claims

1. A tissue imaging and manipulation system, comprising:

a deployment catheter defining at least one lumen therethrough;

a hood comprising a non-inflatable membrane which forms a fluid barrier projecting distally from the deployment catheter and adapted to self-expand into an expanded deployed configuration defining an open area therein, wherein the open area is in fluid communication with the at least one lumen and with an environment external to the hood through an opening defined by the hood; and

a visualization element disposed within or adjacent to the open area of the hood for visualizing tissue adjacent to the open area.

2. The system of claim 1 further comprising a delivery catheter through which the deployment catheter is deliverable.

3. The system of claim 1 wherein the deployment catheter is steerable.

4. The system of claim 3 wherein the deployment catheter is steered via at least one push-pull wire.

5. The system of claim 3 wherein the deployment catheter is steered via computer control.

6. The system of claim 1 wherein the hood is comprised of a compliant material.

7. The system of claim 1 wherein the hood defines a contact edge for placement against a tissue surface.

8. The system of claim 1 wherein the hood is adapted to be reconfigured from a low-profile delivery configuration to the expanded deployed configuration.

9. The system of claim 8 wherein the hood comprises a frame of superelastic or shape memory alloy.

10. The system of claim 1 wherein the hood defines a pleated surface.

11. The system of claim 1 wherein the hood is conically shaped.

12. The system of claim 1 further comprising a compliant material within the hood for reducing a volume of the open area.

13. The system of claim 1 wherein the hood is selectively deployable from the catheter such that the open area is selectively variable.

14. The system of claim 1 wherein the hood comprises a helically expanding frame.

15. The system of claim 1 wherein the hood comprises at least one support member.

16. The system of claim 15 wherein the at least one support member is actuatable via a corresponding pullwire.

17. The system of claim 1 wherein the hood comprises a plurality of radially pivoting members having a membrane disposed therebetween.

18. The system of claim 1 wherein the hood comprises a plurality of radially expanding members each configured to overlap an adjacent member.

19. The system of claim 1 wherein the visualization element comprises at least one optical fiber, CCD imager, or CMOS imager.

20. The system of claim 1 wherein the visualization element is disposed within a distal end of the deployment catheter.

21. The system of claim 1 wherein the visualization element is articulatable off-axis relative to a longitudinal axis of the deployment catheter.

22. The system of claim 1 further comprising a pump for urging fluid into the hood.

23. The system of claim 22 wherein the pump is configured to be controlled via an electronic controller.

24. The system of claim 1 further comprising an antenna for transmitting obtained data wirelessly.

25. The system of claim 1 further comprising a transducer positioned within the hood which is adapted to detect the presence of opaque fluids or debris.

26. The system of claim 1 further comprising at least one sensor disposed within or upon the hood for sensing a physical parameter.

27. The system of claim 1 further comprising at least one light emitting diode disposed within or upon the hood for illuminating the tissue.

28. The system of claim 1 further comprising a helical tissue engager deliverable through the deployment catheter.

29. The system of claim 1 further comprising an ablation element positionable within the hood.

30. The system of claim 29 wherein the ablation element comprises an energizable, cryo-ablation, or laser probe.

31. The system of claim 1 further comprising a tubular cannula extendible through the deployment catheter and through the hood.

32. The system of claim 1 further comprising a tissue anchor assembly positionable upon a contact edge of the hood.

33. The system of claim 32 wherein the tissue anchor assembly comprises a plurality of discrete anchors interconnected via a suture or wire.

34. The system of claim 1 further comprising a fluid reservoir fluidly coupled to the hood.

35. The system of claim 34 wherein the fluid comprises saline, plasma, water, or perfluorinated liquid.

36. A method for imaging an immersed region of tissue, comprising:

positioning a hood projecting distally from a deployment catheter against or adjacent to the region of tissue to be imaged wherein the hood self-expands into an expanded deployed configuration, and where the hood comprises a non-inflatable membrane which defines an open area therein which is in fluid communication with a lumen defined through the catheter and also with an environment external to the hood through an opening defined by the hood;

urging a translucent fluid into the hood via the lumen defined through the deployment catheter such that an opaque fluid is displaced from within the open area of the hood and through the opening into the environment external to the hood; and

visualizing the region of tissue through the translucent fluid via a visualization element within or adjacent to the open area.

37. The method of claim 36 wherein positioning a hood comprises advancing the deployment catheter intravascularly into a chamber of a heart.

38. The method of claim 36 wherein positioning a hood comprises deploying the hood from a low-profile delivery configuration into the expanded deployed configuration.

39. The method of claim 36 wherein positioning a hood comprises steering the deployment catheter to the region of tissue.

40. The method of claim 36 wherein positioning a hood comprises stabilizing a position of the hood relative to the tissue.

41. The method of claim 36 wherein urging a translucent fluid comprises pumping the translucent fluid into the hood through a fluid delivery lumen defined through the deployment catheter.

42. The method of claim 36 wherein urging a translucent fluid comprises urging saline, plasma, water, or perfluorinated liquid into the hood such that blood is displaced from the hood.

43. The method of claim 36 further comprising cooling the translucent fluid prior to urging the fluid into the hood.

44. The method of claim 36 further comprising heating the translucent fluid prior to urging the fluid into the hood.

45. The method of claim 36 further comprising wirelessly transmitting data received from the imaged tissue.

46. The method of claim 36 wherein visualizing the region of tissue further comprises illuminating the region of tissue.

47. The method of claim 46 wherein illuminating the region of tissue comprises illuminating via one or more light emitting diodes.

48. The method of claim 36 wherein visualizing the region of tissue comprises recording an image of the tissue.

49. The method of claim 36 further comprising treating the region of tissue with a therapeutic tool advanced through the deployment catheter.

50. The method of claim 36 further comprising repositioning the hood to a second region of tissue to be imaged.

51. The method of claim 36 further comprising sensing a physical parameter within or outside the hood.

52. The method of claim 36 further comprising deploying an implantable member onto the region of tissue via the hood.

53. The method of claim 36 further comprising deploying an anchoring assembly onto the region of tissue via the hood.

54. A tissue imaging and manipulation system, comprising:

a deployment catheter defining at least one lumen therethrough;

a hood comprising a non-inflatable membrane which forms a fluid barrier projecting distally from the deployment catheter and adapted to self-expand from a low-profile delivery configuration to an expanded deployed configuration which defines an open area therein, wherein the open area is in fluid communication with the at least one lumen and with an environment external to the hood through an opening defined by the hood; and

a visualization element disposed within or adjacent to the open area of the hood for visualizing tissue adjacent to the open area.

55. The system of claim 54 further comprising a delivery catheter through which the deployment catheter is deliverable.

56. The system of claim 54 wherein the deployment catheter is steerable.

57. The system of claim 56 wherein the deployment catheter is steered via at least one push-pull wire.

58. The system of claim 56 wherein the deployment catheter is steered via computer control.

59. The system of claim 54 wherein the hood is comprised of a compliant material.

60. The system of claim 54 wherein the hood comprises a frame of superelastic or shape memory alloy.

61. The system of claim 54 wherein the hood is conically shaped.

62. The system of claim 54 wherein the hood is selectively deployable from the catheter such that the open area is selectively variable.

63. The system of claim 54 wherein the hood comprises at least one support member.

64. The system of claim 54 wherein the visualization element comprises at least one optical fiber, CCD imager, or CMOS imager.

65. The system of claim 54 wherein the visualization element is disposed within a distal end of the deployment catheter.

66. The system of claim 54 further comprising a pump for urging fluid into the hood.

67. The system of claim 66 wherein the pump is configured to be controlled via an electronic controller.

68. The system of claim 54 further comprising an antenna for transmitting obtained data wirelessly.

69. The system of claim 54 further comprising at least one sensor disposed within or upon the hood for sensing a physical parameter.

70. The system of claim 54 further comprising at least one light emitting diode disposed within or upon the hood for illuminating the tissue.

71. The system of claim 54 further comprising an ablation element positionable within the hood.

72. The system of claim 71 wherein the ablation element comprises an energizable, cryo-ablation, or laser probe.

73. The system of claim 54 further comprising a fluid reservoir fluidly coupled to the hood.

74. The system of claim 73 wherein the fluid comprises saline, plasma, water, or perfluorinated liquid.

75. A method for imaging an immersed region of tissue, comprising:

positioning a hood comprising a non-inflatable membrane and projecting distally from a deployment catheter against or adjacent to the region of tissue to be imaged;

transitioning the hood to self-expand from a low-profile delivery configuration into a deployed configuration which defines an open area within;

urging a translucent fluid into the open area of the hood via the deployment catheter such that an opaque fluid is displaced from the open area and into an environment external to the hood through an opening defined by the hood; and

visualizing the region of tissue through the translucent fluid.

76. The method of claim 75 wherein positioning a hood comprises advancing the deployment catheter intravascularly into a chamber of a heart.

77. The method of claim 75 wherein positioning a hood comprises steering the deployment catheter to the region of tissue.

78. The method of claim 75 wherein positioning a hood comprises stabilizing a position of the hood relative to the tissue.

79. The method of claim 75 wherein urging a translucent fluid comprises pumping the translucent fluid into the hood through a fluid delivery lumen defined through the deployment catheter.

80. The method of claim 79 wherein urging a translucent fluid comprises urging saline, plasma, water, or perfluorinated liquid into the hood such that blood is displaced from the hood.

81. The method of claim 75 further comprising cooling the translucent fluid prior to urging the fluid into the hood.

82. The method of claim 75 further comprising heating the translucent fluid prior to urging the fluid into the hood.

83. The method of claim 75 further comprising wirelessly transmitting data received from the imaged tissue.

84. The method of claim 75 wherein visualizing the region of tissue further comprises illuminating the region of tissue.

85. The method of claim 84 wherein illuminating the region of tissue comprises illuminating via one or more light emitting diodes.

86. The method of claim 75 wherein visualizing the region of tissue comprises recording an image of the tissue.

87. The method of claim 75 further comprising treating the region of tissue with a therapeutic tool advanced through the deployment catheter.

88. The method of claim 75 further comprising repositioning the hood to a second region of tissue to be imaged.

89. The method of claim 75 further comprising sensing a physical parameter within or outside the hood.

90. The method of claim 75 further comprising deploying an implantable member onto the region of tissue via the hood.

91. The method of claim 75 further comprising deploying an anchoring assembly onto the region of tissue via the hood.