IP Library Granted Patent US 12,004,707
Granted Patent B2
US 12,004,707 · App. 16/998,278 · Granted Jun 11, 2024

Airway visualization system

Inventors: Bryan I. Hartley (Redwood City, CA); Norbert Pelc (Los Altos, CA); Dimitri Augustin (Los Altos, CA); Racquel Redwood (Sunnyvale, CA); Zach Wolf (Redwood City, CA); Benjamin Berkowitz (Palo Alto, CA); Harmeet Bedi (Los Altos, CA)
Assignee: The Board of Trustees of The Leland Stanford Junior University
A61B1/2676A61B1/00082A61B1/015A61B6/12A61B6/487A61B6/50A61B6/541A61B2562/0247
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Quick Facts
Patent No.
US 12,004,707
App. No.
16/998,278
Granted
Jun 11, 2024
Kind
B2
Abstract

An airway visualization system is described herein having an elongate delivery sheath and defining at least one lumen therethrough, wherein the length is positionable within an airway of a subject. An isolation component positioned near or at a distal end of the elongate delivery sheath is expandable to at least partially obstruct the airway and a controller is in communication with the delivery sheath. The controller is also configured to manipulate a fluid flow through the at least one lumen whereby a pressure change within the airway of the subject is imparted sufficiently to at least partially expand or collapse the airway to alter the density of the airway.

Claims (121)

1. An airway visualization system, comprising:

a delivery sheath having a length and defining at least one lumen therethrough, wherein the length is positionable within an airway of a subject; and

a controller in communication with the delivery sheath,

wherein the controller is configured to manipulate a fluid flow through the at least one lumen whereby a pressure change within the airway of the subject is imparted sufficiently to at least partially manipulate a diameter of the airway to reconfigure between an open resting configuration and a collapsed configuration such that a change in density a position of the airway is imparted at a rate detectable by an imager.

2. The airway visualization system of claim 1 further comprising an isolation component positioned near or at a distal end of the delivery sheath and expandable to at least partially obstruct the airway.

3. The airway visualization system of claim 1 wherein the controller comprises a microcontroller in communication with the delivery sheath.

4. The airway visualization system of claim 3 further comprising a pressure sensor configured to monitor a pressure within the airway and in communication with the microcontroller.

5. The airway visualization system of claim 3 wherein the controller further comprises a fluid pump or suction pump in communication with the microcontroller.

6. The airway visualization system of claim 3 wherein the controller further comprises one or more valves in communication with the microcontroller and also in fluid communication with an external source of gas or a suction pump.

7. The airway visualization system of claim 3 wherein the microcontroller is configured to output an image triggering signal.

8. The airway visualization system of claim 1 further comprising an imaging system in communication with the controller.

9. The airway visualization system of claim 8 wherein the imaging system comprises an x-ray imager.

10. The airway visualization system of claim 8 wherein the controller is configured to trigger or gate the imaging system with the pressure change.

11. The airway visualization system of claim 1 wherein the controller is configured to manipulate the fluid flow at a frequency of between 0.5 to 50 Hz.

12. The airway visualization system of claim 1 wherein the controller is configured to manipulate the fluid flow to have a pressure change of between 1 to 50 cmH2O or between −1 and −150 cmH2O.

13. The airway visualization system of claim 1 further comprising a vibrational component in communication with the delivery sheath and configured to vibrationally conduct to the airway.

14. A method of visualizing an airway within a subject, comprising:

positioning a delivery sheath through at least a portion of the airway and into proximity to a tissue region of interest within a lung;

manipulating a fluid flow through at least one lumen of the delivery sheath such that a pressure change is imparted within the airway sufficient to at least partially manipulate a diameter of the airway to reconfigure between an open resting configuration and a collapsed configuration such that a change in density of the airway is imparted while a remainder of the lung remains unaffected; and

obtaining an image of the airway via an imager while the position of the airway is manipulated.

15. The method of claim 14 further comprising:

obtaining a baseline image of the airway via the imager prior to manipulating the fluid flow;

obtaining a target image of the airway via the imager while the position of the airway is manipulated; and

digitally subtracting the target image from the baseline image to obtain a visual representation of the airway.

16. The method of claim 14 wherein positioning the delivery sheath further comprises fluidly isolating the airway.

17. The method of claim 14 wherein manipulating the fluid flow comprises infusing a fluid at a positive pressure through the at least one lumen to at least partially expand the airway.

18. The method of claim 17 further comprising suctioning the fluid from the airway to at least partially collapse the airway.

19. The method of claim 14 wherein manipulating the fluid flow comprises suctioning a fluid from the airway at a negative pressure through the at least one lumen to at least partially collapse the airway.

20. The method of claim 19 further comprising infusing the fluid at a positive pressure through the at least one lumen to at least partially expand the airway.

21. The method of claim 14 wherein obtaining the image of the airway comprises imaging the airway at a rate detectable by the imager.

22. The method of claim 21 wherein an imager frame rate is at least twice a frequency of pressure change.

23. The method of claim 14 wherein manipulating the fluid flow comprises manipulating the pressure change at a frequency of between 0.5 to 50 Hz.

24. The method of claim 14 wherein manipulating the fluid flow comprises imparting a positive pressure to the airway of between 1 to 50 cmH2O.

25. The method of claim 14 wherein manipulating the fluid flow comprises imparting a negative pressure to the airway of between −1 and −150 cmH2O.

26. The method of claim 14 wherein obtaining the image comprises obtaining an x-ray image of the airway.

27. The method of claim 14 wherein obtaining the image comprises timing the image to correspond to the manipulation of the fluid flow.

28. The method of claim 14 wherein obtaining the image comprises gating when the image is obtained to correspond to a physical parameter of the subject.

29. The method of claim 14 further comprising superimposing the visual representation of the airway upon a real-time image of the airway.

30. A method of visualizing an airway within a subject, comprising:

positioning a delivery sheath through at least a portion of the airway and into proximity to a tissue region of interest;

obtaining a baseline image of the airway via an imager;

manipulating a fluid flow through at least one lumen of the delivery sheath such that a pressure change is imparted within the airway sufficient to at least partially expand or collapse the airway such that a diameter of the airway is reconfigured to impart a change in density of the airway at a rate detectable by the imager;

obtaining a target image of the airway via the imager; and

digitally subtracting the target image from the baseline image to obtain a visual representation of the airway.

31. An airway visualization system, comprising:

a delivery sheath having a length and defining at least one lumen therethrough, wherein the length is positionable within an airway of a subject; and

a controller in communication with the delivery sheath, wherein the controller is configured to manipulate a fluid flow through the at least one lumen whereby an alternating pressure change is imparted within the airway of the subject to reconfigure a diameter of the airway between a first diameter configuration and a collapsed second configuration to correspondingly alter a density of the airway for visualization.

32. The airway visualization system of claim 31 further comprising an isolation component positioned near or at a distal end of the delivery sheath and expandable to at least partially obstruct the airway.

33. The airway visualization system of claim 31 wherein the controller comprises a microcontroller in communication with the delivery sheath.

34. The airway visualization system of claim 33 further comprising a pressure sensor configured to monitor a pressure within the airway and in communication with the microcontroller.

35. The airway visualization system of claim 33 wherein the controller further comprises a fluid pump or suction pump in communication with the microcontroller.

36. The airway visualization system of claim 33 wherein the controller further comprises one or more valves in communication with the microcontroller and also in fluid communication with an external source of gas or a suction pump.

37. The airway visualization system of claim 33 wherein the microcontroller is configured to output an image triggering signal.

38. The airway visualization system of claim 31 further comprising an imaging system in communication with the controller.

39. The airway visualization system of claim 38 wherein the imaging system comprises an x-ray imager.

40. The airway visualization system of claim 38 wherein the controller is configured to trigger or gate the imaging system with the pressure change.

41. The airway visualization system of claim 31 wherein the controller is configured to manipulate the fluid flow at a frequency of between 0.5 to 50 Hz.

42. The airway visualization system of claim 31 wherein the controller is configured to manipulate the fluid flow to have a pressure change of between −10 to 30 cmH2O.

43. The airway visualization system of claim 31 wherein the controller is configured to manipulate the fluid flow to have a pressure change of between 0 to 30 cmH2O.

44. The airway visualization system of claim 31 wherein the controller is configured to manipulate the fluid flow to have a pressure change of between −30 to 0 cmH2O.

45. The airway visualization system of claim 31 further comprising a vibrational component in communication with the delivery sheath and configured to vibrationally conduct to the airway.

46. A method of visualizing an airway within a subject, comprising:

positioning a delivery sheath through at least a portion of the airway and into proximity to a tissue region of interest within a lung;

manipulating a fluid flow through at least one lumen of the delivery sheath such that an alternating pressure change is imparted within the airway;

altering a diameter of the airway to reconfigure between a first diameter and a collapsed second diameter such that a change in density of the airway is imparted corresponding to the alternating pressure change; and

visualizing the airway via an imager.

47. The method of claim 46 wherein visualizing the airway comprises:

obtaining a baseline image of the airway via the imager prior to manipulating the fluid flow;

obtaining a target image of the airway via the imager while the position of the airway is manipulated; and

digitally subtracting the target image from the baseline image to obtain a visual representation of the airway.

48. The method of claim 46 wherein positioning the delivery sheath further comprises fluidly isolating the airway.

49. The method of claim 46 wherein manipulating the fluid flow comprises infusing a fluid at a positive pressure through the at least one lumen to at least partially expand the airway.

50. The method of claim 49 further comprising suctioning the fluid from the airway to at least partially collapse the airway.

51. The method of claim 50 wherein infusing the fluid comprises infusing the fluid at a pressure of 30 cmH2O and suctioning the fluid at a pressure of −10 cmH2O.

52. The method of claim 50 wherein infusing the fluid comprises infusing the fluid at a pressure of 30 cmH2O and suctioning the fluid at a pressure of 0 cmH2O.

53. The method of claim 50 wherein infusing the fluid comprises infusing the fluid at a pressure of 0 cmH2O and suctioning the fluid at a pressure of −30 cmH2O.

54. The method of claim 46 wherein visualizing the airway comprises imaging the airway at a rate detectable by the imager.

55. The method of claim 54 wherein an imager frame rate is at least twice a frequency of pressure change.

56. The method of claim 46 wherein visualizing the airway comprises obtaining an x-ray image of the airway.

57. The method of claim 46 wherein visualizing the airway comprises timing the image to correspond to the manipulation of the fluid flow.

58. The method of claim 46 wherein visualizing the airway comprises gating when the image is obtained to correspond to a physical parameter of the subject.

59. The method of claim 46 further comprising superimposing a visual representation of the airway upon a real-time image of the airway.

60. A method of altering a density of tissue within a subject, comprising:

positioning a delivery sheath through at least a portion of the airways and into proximity to one or more structures of interest within a lung;

manipulating a fluid flow through at least one lumen of the delivery sheath such that an alternating pressure change is imparted within the airways;

altering a diameter of the airways to reconfigure between a first diameter and a collapsed second diameter such that the density of the airways is altered corresponding to the alternating pressure change, wherein the airways are in proximity to the one or more structures of interest; and

visualizing the one or more structures of interest based on the airways in proximity to the one or more structures of interest via an imager.

61. The method of claim 60 wherein visualizing the one or more structures comprises:

obtaining a baseline image of the airways in proximity to the one or more structures of interest via the imager prior to manipulating the fluid flow;

obtaining a target image of the airways in proximity to the one or more structures of interest via the imager while the position of the airways is manipulated; and

digitally subtracting the target image from the baseline image to obtain a visual representation of the one or more structures.

62. The method of claim 60 wherein positioning the delivery sheath further comprises fluidly isolating the airway.

63. The method of claim 60 wherein manipulating the fluid flow comprises infusing a fluid at a positive pressure through the at least one lumen to at least partially expand the airway.

64. The method of claim 63 further comprising suctioning the fluid from the airway to at least partially collapse the airway.

65. The method of claim 64 wherein infusing the fluid comprises infusing the fluid at a pressure of 30 cmH2O and suctioning the fluid at a pressure of −10 cmH2O.

66. The method of claim 64 wherein infusing the fluid comprises infusing the fluid at a pressure of 30 cmH2O and suctioning the fluid at a pressure of 0 cmH2O.

67. The method of claim 64 wherein infusing the fluid comprises infusing the fluid at a pressure of 0 cmH2O and suctioning the fluid at a pressure of −30 cmH2O.

68. The method of claim 60 wherein visualizing the one or more structures comprises imaging the airways at a rate detectable by the imager.

69. The method of claim 68 wherein an imager frame rate is at least twice a frequency of pressure change.

70. The method of claim 60 wherein visualizing the one or more structures comprises obtaining an x-ray image of one or more nodules.

71. The method of claim 60 wherein visualizing the one or more structures comprises timing the image to correspond to the manipulation of the fluid flow.

72. The method of claim 60 wherein visualizing the one or more structures comprises gating when the image is obtained to correspond to a physical parameter of the subject.

73. The method of claim 60 further comprising superimposing a visual representation of the one or more structures upon a real-time image of the one or more structures.

74. A method of visualizing a tissue region of interest within a subject, comprising:

positioning a delivery sheath through at least a portion of the airway and into proximity to the tissue region of interest within a lung;

contacting a tissue wall of the airway with a portion of the delivery sheath;

conducting a vibration from the portion of the delivery sheath and into the tissue wall such that the vibration is transmitted to the tissue region of interest;

altering a density of the tissue region of interest between a first density and a second density such that a change in the density is imparted to the tissue region of interest via the vibration; and

visualizing the tissue region of interest via an imager.

75. The method of claim 74 wherein visualizing the tissue region of interest comprises:

obtaining a baseline image of the tissue region of interest via the imager prior to conducting the vibration;

obtaining a target image of the tissue region of interest via the imager while the position of the tissue region of interest is manipulated; and

digitally subtracting the target image from the baseline image to obtain a visual representation of the tissue region of interest.

76. The method of claim 74 wherein visualizing the tissue region of interest comprises imaging at least the portion of the airway.

77. The method of claim 74 wherein visualizing the tissue region of interest comprises imaging one or more nodules within the lung.

78. The method of claim 74 wherein conducting the vibration comprises imparting the vibration at a frequency of 0.5 to 50 Hz.

79. The method of claim 74 wherein visualizing the tissue region of interest comprises imaging the airway at a rate detectable by the imager.

80. The method of claim 79 wherein an imager frame rate is at least twice a frequency of the vibration.

81. The method of claim 74 wherein visualizing the tissue region of interest comprises obtaining an x-ray image of the tissue region of interest.

82. The method of claim 74 wherein visualizing the tissue region of interest comprises gating when the image is obtained to correspond to a physical parameter of the subject.

83. The method of claim 74 further comprising superimposing a visual representation of the tissue region of interest upon a real-time image of the tissue region of interest.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 2, 2020
From: HARTLEY, BRYAN I.; PELC, NORBERT; AUGUSTIN, DIMITRI; REDWOOD, RACQUEL; WOLF, ZACH; BERKOWITZ, BENJAMIN; BEDI, HARMEET
To: THE BOARD OF TRUSTEES OF THE LELAND STANFORD JUNIOR UNIVERSITY
Reel/Frame 054247/0304 →
Continuity (4)
Continuation PCTUS2019027949 · Apr 17, 2019
Provisional Application 62737793 · Sep 27, 2018
Provisional Application 62659032 · Apr 17, 2018
Related Publication 20200375448A1 · Dec 3, 2020