Endoscope structures and techniques for navigating to a target in branched structure

• US 20040249267A1
• Filed: 03/29/2004
• Published: 12/09/2004
• Est. Priority Date: 04/17/2002
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Super Dimension Ltd.
• Inventors: Gilboa, Pinhas
• Granted Patent: US 7,233,820 B2
• Time in Patent Office: Days
• US Class Current: 600/424
• CPC Class Codes: A61B 1/00154 using guiding arrangements for insertion
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 5/06 Devices, other than using radiation, for detecting or locating foreign bodies for removing same A61B17/50 ; determining position of probes within or on the body of the patient
• CPC Class Codes: A61B 5/065 Determining position of the probe employing exclusively positioning means located on or in the probe, e.g. using position sensors arranged on the probe

Abstract

Systems and methods employing a small guage steerable catheter (30) including a locatable guide (32) with a sheath (40), particularly as an enhancement to a bronchoscope (14). A typical procedure is as follows. The location of a target in a reference coordinate system is detected or imported. The catheter (30) is navigated to the target which tracking the distal tip (34) of the guide (32) in the reference coordinate system. Insertion of the catheter is typically via a working channel of a convention bronchoscope. Once the tip of the catheter is positioned at the target, the guide (32) is withdrawn, leaving the sheath (40) secured in place. The sheath (40) is then used as a guide channel to direct a medical tool to target.

Claims

1. A method for steering a catheter through a branched structure to a target location, the method comprising:

(a) providing a flexible, steerable catheter with a position sensor element located near a distal tip of the catheter, the position sensor element being part of a position measuring system measuring a position and a pointing direction of the tip of the catheter relative to a three-dimensional frame of reference;

(b) designating the target location relative to the three-dimensional frame of reference;

(c) advancing the catheter into the branched structure; and

(d) displaying a representation of at least one parameter defined by a geometrical relation between the pointing direction of the tip of the catheter and a direction from the tip of the catheter towards the target location.

2. The method of claim 1, wherein the at least one parameter includes an angular deviation between the pointing direction of the tip of the catheter and a direction from the tip of the catheter towards the target location.

3. The method of claim 1, wherein the at least one parameter includes a direction of deflection required to bring the pointing direction of the catheter into alignment with the target location.

4. The method of claim 1, wherein said representation of at least one parameter is displayed in the context of a representation of a view taken along the pointing direction of the tip of the catheter.

5. The method of claim 1, wherein the position sensor element is part of a six-degrees-of-freedom position measuring system measuring the position and attitude of the tip of the catheter in three translational and three rotational degrees of freedom.

6. The method of claim 1, further comprising providing the catheter with a multi-directional steering mechanism configured for selectively deflecting a distal portion of the catheter in any one of at least three different directions.

7. The method of claim 1, further comprising:

(a) monitoring by use of the position sensor element a path traveled by the tip of the catheter; and

(b) displaying a representation of the path traveled together with a current position of the tip, the representation being projected as viewed from at least one direction non-parallel to the pointing direction of the tip.

8. The method of claim 1, wherein said designating the target location is performed by:

(i) designating a target location by use of computerized tomography data generated from the branched structure; and

(ii) registering the computerized tomography data with the three-dimensional frame of reference.

9. The method of claim 8, wherein said registering is performed by:

(i) providing the steerable catheter with a camera;

(ii) generating a camera view of each of at least three distinctive features within the branched structure;

(iii) generating from the computerized tomography data a simulated view of each of the at least three distinctive features, each camera view and a corresponding one of the simulated views constituting a pair of similar views;

(iv) allowing an operator to designate a reference point viewed within each of the camera views and a corresponding reference point viewed within each corresponding simulated view; and

(v) deriving from the designated reference points a best fit registration between the computerized tomography data and the three-dimensional frame of reference.

10. The method of claim 8, further comprising:

(a) designating by use of the computerized tomography data an intended route through the branched structure; and

(b) displaying a representation of the intended route together with a current position of the tip, the representation being projected as viewed from at least one direction non-parallel to the pointing direction of the tip.

11. The method of claim 8, further comprising:

(a) detecting a current position of the position sensor element;

(b) generating from the computerized tomography data a virtual endoscopy image corresponding to an image that would be viewed by a camera located in predefined spatial relationship and alignment relative to the position sensor element; and

(c) displaying the virtual endoscopy image.

12. The method of claim 1, wherein the branched structure is a lung structure.

13. The method of claim 12, further comprising processing measurements of the position and pointing direction of the tip of the catheter so as to reduce variations resulting from cyclic motion.

14. The method of claim 13, wherein said processing includes selectively taking measurements at an extreme of a cyclic motion.

15. The method of claim 13, wherein said processing includes applying a low-frequency filter to the measurements.

16. The method of claim 13, wherein said processing includes calculating an average of the measurements over a time period of the cyclic motion.

17. The method of claim 1, wherein the steerable catheter further includes:

a sheath having a lumen extending from a proximal insertion opening to a distal opening; and

a guide element configured for insertion through said proximal opening of said sheath to an inserted position extending along said lumen to said distal opening, said guide element including at least part of an imaging system deployed for taking optical images of a region beyond said distal opening, the method further comprising;

(a) guiding said steerable catheter to a position with said tip adjacent to the target location; and

(b) withdrawing said guide element from said lumen to leave said lumen available for insertion of a medical tool.

18. The method of claim 17, further comprising preparing a medical tool for insertion into said lumen by:

(a) inserting the medical tool into a calibration tube, the calibration tube having a length corresponding to a length of the lumen; and

(b) marking an extent of insertion on the tool.

19. The method of claim 18, wherein said calibration tube is a coiled storage tube employed to store said guide element prior to use, said guide element being removed from said storage tube prior to inserting the tool.

20. The method of claim 1, wherein the steerable catheter further includes a handle having a working channel, a sheath deployed within the working channel and having an internal lumen, and a guide element including the position sensor element deployed within the lumen, the method further comprising:

(a) locking the guide element within the sheath so as to prevent movement of the guide element relative to the sheath;

(b) guiding the sheath and the guide element to the target location;

(c) locking the sheath within the working channel to prevent relative movement of the sheath relative to the handle; and

(d) unlocking and withdrawing the guide element from the sheath so as to leave the lumen of the sheath in place as a guide for inserting a tool to the target location.

21. The method of claim 20, further comprising providing a selectively actuatable anchoring mechanism associated with a portion of the sheath.

22. The method of claim 21, wherein the selectively actuatable anchoring mechanism includes an inflatable element.

23. The method of claim 21, wherein the selectively actuatable anchoring mechanism includes a mechanically deployed element.

24. The method of claim 20, wherein the guide element further includes an image sensor deployed for generating an image in the pointing direction of the catheter, the image sensor being withdrawn from the sheath as part of the guide element.

25. The method of claim 24, wherein at least part of said location sensor is formed from translucent material, the method further comprising illuminating at least part of a field of view of the image sensor by directing illumination through at least one region of said translucent material.

26. The method of claim 24, further comprising illuminating at least part of a field of view of the image sensor by using at least a distal portion of the sheath as an optical waveguide.

27. The method of claim 26, wherein illumination is supplied to the optical waveguide from at least one light source mounted within the guide element.

28. The method of claim 26, wherein illumination is supplied to the optical waveguide from at least one light source associated with the handle.

29. The method of claim 20, wherein the guide element further includes a radioactivity sensor, the sensor being withdrawn from the sheath as part of the guide element.

30. The method of claim 1, wherein the steerable catheter is a flexible endoscope.

31. The method of claim 1, wherein the steerable catheter is a flexible bronchoscope.

32. A method for achieving registration between computerized tomography data and a three dimensional frame of reference of a position measuring system, the method comprising:

(a) providing a catheter with;

(i) a position sensor element which operates as part of the position measuring system to allow measurement of a position and a pointing direction of the tip of the catheter relative to the three-dimensional frame of reference, and

(ii) an image sensor;

(b) generating from the computerized tomography data at least three simulated views of distinctive features within the branched structure;

(c) generating at least three camera views of the distinctive features, each camera view and a corresponding one of the simulated views constituting a pair of similar views;

(d) allowing an operator to designate a reference point viewed within each of the camera views and a corresponding reference point viewed within each corresponding simulated view; and

(e) deriving from the designated reference points a best fit registration between the computerized tomography image and the three-dimensional frame of reference.

38. A method for achieving registration between computerized tomography data and a three dimensional frame of reference of a position measuring system, the method comprising:

(a) providing a catheter with;

(i) a position sensor element which operates as part of the position measuring system to allow measurement of a position and a pointing direction of the tip of the catheter relative to the three-dimensional frame of reference, and

(ii) an image sensor;

(b) moving the tip of the catheter along a first branch portion of a branched structure and deriving a plurality of images from the camera, each image being associated with corresponding position data of the position sensor in said three dimensional frame of reference;

(c) processing said images and corresponding position data to derive a best-fit of a predefined geometrical model to said first branch portion in said three dimensional frame of reference;

(d) repeating steps (b) and (c) for a second branch portion of the branched structure; and

(e) correlating said geometrical models of said first and second branch portions with the computerized tomography data to derive a best fit registration between the computerized tomography data and the three dimensional frame of reference.

33. The method of claim 38, wherein designation of a reference point within each of the camera views by the operator is performed by the operator bringing the position sensor element into proximity with the reference point.

34. The method of claim 38, wherein designation of a reference point within each simulated view by the operator is performed by:

(a) the operator selecting a simulated image reference point within each simulated view;

(b) calculating from the simulated image reference point a simulated-viewing-point-to-reference-point vector; and

(c) calculating a point of intersection between said simulated-viewing-point-to-reference-point vector and a tissue surface in a numerical model of a portion of the body derived from the computerized tomography data.

35. The method of claim 38, further comprising:

(a) identifying at least one location within the computerized tomography data;

(b) calculating a position of the at least one location within the three-dimensional frame of reference; and

(c) displaying a representation of the at least one location together with a representation of a position of the position sensor element.

36. The method of claim 40, wherein said at least one location includes a target location to which a medical tool is to be directed.

37. The method of claim 40, wherein said at least one location is a series of locations defining a planned path along which a medical tool is to be directed.

39. The method of claim 38, wherein said processing said images and corresponding position data includes:

(a) identifying visible features each of which is present in plural images taken at different positions;

(b) for each of said visible features, deriving a camera-to-feature direction in each of a plurality of said images;

(c) employing said camera-to-feature directions and corresponding position data to determine a feature position for each visible feature; and

(d) deriving a best-fit of the predefined geometrical model to the feature positions.

40. The method of claim 38, wherein the predefined geometrical model is a cylinder.

41. The method of claim 38, further comprising:

(a) identifying at least one location within the computerized tomography data;

(b) calculating a position of the at least one location within the three-dimensional frame of reference; and

(c) displaying a representation of the at least one location together with a representation of a position of the position sensor element.

42. The method of claim 41, wherein said at least one location includes a target location to which a medical tool is to be directed.

43. The method of claim 41, wherein said at least one location is a series of locations defining a planned path along which a medical tool is to be directed.

44. An endoscope for guiding a medical tool to a target location, the endoscope comprising:

(a) a sheath having a lumen extending from a proximal insertion opening to a distal opening;

(b) a guide element configured for insertion through said proximal opening of said sheath to an inserted position extending along said lumen to said distal opening, said guide element including at least part of an imaging system deployed for taking optical images of a region beyond said distal opening; and

(c) at least one steering mechanism for co-deflecting said sheath and said guide element,

wherein said guide element is retractable from said lumen to leave said lumen available for insertion of a medical tool.

45. The endoscope of claim 44, wherein said at least part of an imaging system includes an optical sensor chip deployed at a distal end of said guide element.

46. The endoscope of claim 44, wherein the guide element includes a position sensor element, the position sensor element being part of a position measuring system measuring a position and a pointing direction of a tip of the guide element relative to a three-dimensional frame of reference.

47. The endoscope of claim 46, wherein at least part of said position sensor element is formed from translucent material, the endoscope further comprising an illumination arrangement deployed to direct illumination through at least one region of said translucent material so as to illuminate at least part of the region beyond said distal opening.

48. The endoscope of claim 44, further comprising a selectively actuatable anchoring mechanism associated with a portion of the sheath.

49. The endoscope of claim 48, wherein the selectively actuatable anchoring mechanism includes an inflatable element.

50. The endoscope of claim 48, wherein the selectively actuatable anchoring mechanism includes a mechanically deployed element.

51. The endoscope of claim 44, wherein at least a distal part of the sheath is substantially radio-opaque.

52. The endoscope of claim 44, further comprising at least one radio-opaque marked associated with a distal end of the sheath.

53. The endoscope of claim 44, wherein at least a distal portion of the sheath is implemented as an optical waveguide.

54. The endoscope of claim 44, further comprising at least one light source mounted within the guide element for illuminating at least part of the region beyond said distal opening.

55. The endoscope of claim 44, further comprising at least one optical fiber deployed along the length of the guide element for delivering illumination to at least part of the region beyond said distal opening.

56. The endoscope of claim 44, wherein the guide element further includes a radioactivity sensor, the sensor being withdrawn from the sheath as part of the guide element.

57. A method of guiding a medical tool through a branched structure to a target location, the method comprising:

(a) providing a catheter assembly including a handle having a working channel, a sheath deployed within the working channel and having an internal lumen, and a guide element deployed within the lumen;

(b) locking the guide element within the sheath so as to prevent movement of the guide element relative to the sheath;

(c) guiding the sheath and the guide element to the target location;

(d) locking the sheath within the working channel to prevent relative movement of the sheath relative to the handle; and

(e) unlocking and withdrawing the guide element from the sheath so as to leave the lumen of the sheath in place as a guide for inserting a tool to the target location.

58. The method of claim 57, wherein the guide element includes a position sensor element, the position sensor element being part of a position measuring system measuring a position and a pointing direction of a tip of the guide element relative to a three-dimensional frame of reference.

59. The method of claim 57, further comprising providing a selectively actuatable anchoring mechanism associated with a portion of the sheath.

60. The method of claim 59, wherein the selectively actuatable anchoring mechanism includes an inflatable element.

61. The method of claim 59, wherein the selectively actuatable anchoring mechanism includes a mechanically deployed element.

62. The method of claim 57, wherein at least a distal part of the sheath is treated so as to be substantially radio-opaque.

63. The method of claim 57, further comprising providing at least one radio-opaque marked associated with a distal end of the sheath.

64. The method of claim 57, wherein the guide element further includes an image sensor deployed for generating an image in the pointing direction of the catheter, the image sensor being withdrawn from the sheath as part of the guide element.

65. The method of claim 64, further comprising illuminating a field of view of the image sensor by using at least a distal portion of the sheath as an optical waveguide.

66. The method of claim 65, wherein illumination is supplied to the optical waveguide from at least one light source mounted within the guide element.

67. The method of claim 65, wherein illumination is supplied to the optical waveguide from at least one light source associated with the handle.

68. The method of claim 57, wherein the guide element further includes a radioactivity sensor, the sensor being withdrawn from the sheath as part of the guide element.

69. The method of claim 57, further comprising preparing a medical tool for insertion into said lumen by:

(a) inserting the medical tool into a calibration tube, the calibration tube having a length corresponding to a length of the lumen; and

(b) marking an extent of insertion on the tool.

70. The method of claim 69, wherein said calibration tube is a coiled storage tube employed to store said guide element prior to use, said guide element being removed from said storage tube prior to inserting the tool.

71. A steering mechanism for selectively deflecting a distal portion of a steerable catheter in any one of at least two independent directions, the mechanism comprising:

(a) at least three elongated tensioning elements extending along the catheter and configured such that tension applied to any one of said tensioning elements causes deflection of a tip of the catheter in a corresponding predefined direction;

(b) an actuator displaceable from a first position to a second position; and

(c) a selector mechanism configured for selectively mechanically interconnecting a selected at least one of said elongated tensioning elements and said actuator such that displacement of said actuator from said first position to said second position applies tension to said selected at least one of said elongated tensioning elements.

72. The steering mechanism of claim 71, wherein a first state of said selector mechanism mechanically interconnects a single one of said elongated tensioning elements with said actuator such that displacement of said actuator generates deflection of said tip in one of said predefined directions, and a second state of said selector mechanism mechanically interconnects two of said elongated tensioning elements with said actuator such that displacement of said actuator generates deflection of said tip in an intermediate direction between two of said predefined directions.

73. The steering mechanism of claim 71, wherein said at least three tensioning elements includes an even number of said tensioning elements, pairs of said tensioning elements being implemented as a single elongated element extending from said selector mechanism along the catheter to said tip and back along the catheter to said selector mechanism.

74. The steering mechanism of claim 71, wherein said at least three tensioning elements is implemented as four tensioning elements deployed such that each tensioning element, when actuated alone, causes deflection of said tip in a different one of four predefined directions separated substantially by multiples of 90°

.

75. The steering mechanism of claim 74, wherein a first state of said selector mechanism mechanically interconnects a single one of said elongated tensioning elements with said actuator such that displacement of said actuator generates deflection of said tip in one of said four predefined directions, and a second state of said selector mechanism mechanically interconnects two of said elongated tensioning elements with said actuator such that displacement of said actuator generates deflection of said tip in one of four intermediate directions each lying between two of said four predefined directions.

76. The steering mechanism of claim 71, wherein said actuator includes a ring which is slidable relative to a handle associated with the catheter, and wherein said selector mechanism includes a slide attached to each of said tensioning elements and slidably deployed within said handle and at least one projection projecting from said ring such that, when said ring is rotated, said at least one projection selectively engages at least one of said slides such that displacement of said ring causes movement of said at least one slide.