# US 12,004,707 B2 · Airway visualization system > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,004,707 B2 - Document ID: US12004707B2 - Status: Granted - Kind: B2 - Application number: 16/998,278 - Filed: 2020-08-20 - Published: 2020-12-03 - Granted: 2024-06-11 - Earliest claimed: 2018-04-17 - Assignees: The Board of Trustees of the Leland Stanford Junior University - Applicants: The Board of Trustees of The Leland Stanford Junior University - Inventors: Bryan I. Hartley; Norbert Pelc; Dimitri Augustin; Racquel Redwood; Zach Wolf; Benjamin Berkowitz; Harmeet Bedi - Web page: https://patentgrep.com/patent/US12004707B2 ## CPC - A61B 1/2676: {Bronchoscopes} - A61B 1/00082: {Balloons} - A61B 1/015: Control of fluid supply or evacuation - A61B 1/267: for the respiratory tract, e.g. laryngoscopes or bronchoscopes - A61B 5/08: Measuring devices for evaluating the respiratory organs - A61B 6/12: Arrangements for detecting or locating foreign bodies - A61B 6/487: {involving fluoroscopy} - A61B 6/50: specially adapted for specific body parts; specially adapted for specific clinical applications - A61B 6/541: {involving acquisition triggered by a physiological signal} - A61M 25/0032: {characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts} - A61M 25/1002: {characterised by balloon shape (A61M25/1006, A61M25/1009 take precedence)} - A61B 2562/0247: Pressure sensors - A61M 25/007: {Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked} - A61M 25/0133: {Tip steering devices} - A61M 2025/0096: {being laterally outward extensions or tools, e.g. hooks or fibres} - A61M 2025/1052: {for temporarily occluding a vessel for isolating a sector} - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} ## 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 ### Claim 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. ### Claim 2 (depends on 1) 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. ### Claim 3 (depends on 1) The airway visualization system of claim 1 wherein the controller comprises a microcontroller in communication with the delivery sheath. ### Claim 4 (depends on 3) 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. ### Claim 5 (depends on 3) The airway visualization system of claim 3 wherein the controller further comprises a fluid pump or suction pump in communication with the microcontroller. ### Claim 6 (depends on 3) 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. ### Claim 7 (depends on 3) The airway visualization system of claim 3 wherein the microcontroller is configured to output an image triggering signal. ### Claim 8 (depends on 1) The airway visualization system of claim 1 further comprising an imaging system in communication with the controller. ### Claim 9 (depends on 8) The airway visualization system of claim 8 wherein the imaging system comprises an x-ray imager. ### Claim 10 (depends on 8) The airway visualization system of claim 8 wherein the controller is configured to trigger or gate the imaging system with the pressure change. ### Claim 11 (depends on 1) 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. ### Claim 12 (depends on 1) 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. ### Claim 13 (depends on 1) 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. ### Claim 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. ### Claim 15 (depends on 14) 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. ### Claim 16 (depends on 14) The method of claim 14 wherein positioning the delivery sheath further comprises fluidly isolating the airway. ### Claim 17 (depends on 14) 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. ### Claim 18 (depends on 17) The method of claim 17 further comprising suctioning the fluid from the airway to at least partially collapse the airway. ### Claim 19 (depends on 14) 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. ### Claim 20 (depends on 19) 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. ### Claim 21 (depends on 14) The method of claim 14 wherein obtaining the image of the airway comprises imaging the airway at a rate detectable by the imager. ### Claim 22 (depends on 21) The method of claim 21 wherein an imager frame rate is at least twice a frequency of pressure change. ### Claim 23 (depends on 14) 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. ### Claim 24 (depends on 14) The method of claim 14 wherein manipulating the fluid flow comprises imparting a positive pressure to the airway of between 1 to 50 cmH2O. ### Claim 25 (depends on 14) The method of claim 14 wherein manipulating the fluid flow comprises imparting a negative pressure to the airway of between −1 and −150 cmH2O. ### Claim 26 (depends on 14) The method of claim 14 wherein obtaining the image comprises obtaining an x-ray image of the airway. ### Claim 27 (depends on 14) The method of claim 14 wherein obtaining the image comprises timing the image to correspond to the manipulation of the fluid flow. ### Claim 28 (depends on 14) 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. ### Claim 29 (depends on 14) The method of claim 14 further comprising superimposing the visual representation of the airway upon a real-time image of the airway. ### Claim 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. ### Claim 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. ### Claim 32 (depends on 31) 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. ### Claim 33 (depends on 31) The airway visualization system of claim 31 wherein the controller comprises a microcontroller in communication with the delivery sheath. ### Claim 34 (depends on 33) 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. ### Claim 35 (depends on 33) The airway visualization system of claim 33 wherein the controller further comprises a fluid pump or suction pump in communication with the microcontroller. ### Claim 36 (depends on 33) 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. ### Claim 37 (depends on 33) The airway visualization system of claim 33 wherein the microcontroller is configured to output an image triggering signal. ### Claim 38 (depends on 31) The airway visualization system of claim 31 further comprising an imaging system in communication with the controller. ### Claim 39 (depends on 38) The airway visualization system of claim 38 wherein the imaging system comprises an x-ray imager. ### Claim 40 (depends on 38) The airway visualization system of claim 38 wherein the controller is configured to trigger or gate the imaging system with the pressure change. ### Claim 41 (depends on 31) 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. ### Claim 42 (depends on 31) 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. ### Claim 43 (depends on 31) 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. ### Claim 44 (depends on 31) 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. ### Claim 45 (depends on 31) 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. ### Claim 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. ### Claim 47 (depends on 46) 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. ### Claim 48 (depends on 46) The method of claim 46 wherein positioning the delivery sheath further comprises fluidly isolating the airway. ### Claim 49 (depends on 46) 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. ### Claim 50 (depends on 49) The method of claim 49 further comprising suctioning the fluid from the airway to at least partially collapse the airway. ### Claim 51 (depends on 50) 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. ### Claim 52 (depends on 50) 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. ### Claim 53 (depends on 50) 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. ### Claim 54 (depends on 46) The method of claim 46 wherein visualizing the airway comprises imaging the airway at a rate detectable by the imager. ### Claim 55 (depends on 54) The method of claim 54 wherein an imager frame rate is at least twice a frequency of pressure change. ### Claim 56 (depends on 46) The method of claim 46 wherein visualizing the airway comprises obtaining an x-ray image of the airway. ### Claim 57 (depends on 46) The method of claim 46 wherein visualizing the airway comprises timing the image to correspond to the manipulation of the fluid flow. ### Claim 58 (depends on 46) 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. ### Claim 59 (depends on 46) The method of claim 46 further comprising superimposing a visual representation of the airway upon a real-time image of the airway. ### Claim 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. ### Claim 61 (depends on 60) 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. ### Claim 62 (depends on 60) The method of claim 60 wherein positioning the delivery sheath further comprises fluidly isolating the airway. ### Claim 63 (depends on 60) 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. ### Claim 64 (depends on 63) The method of claim 63 further comprising suctioning the fluid from the airway to at least partially collapse the airway. ### Claim 65 (depends on 64) 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. ### Claim 66 (depends on 64) 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. ### Claim 67 (depends on 64) 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. ### Claim 68 (depends on 60) The method of claim 60 wherein visualizing the one or more structures comprises imaging the airways at a rate detectable by the imager. ### Claim 69 (depends on 68) The method of claim 68 wherein an imager frame rate is at least twice a frequency of pressure change. ### Claim 70 (depends on 60) The method of claim 60 wherein visualizing the one or more structures comprises obtaining an x-ray image of one or more nodules. ### Claim 71 (depends on 60) 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. ### Claim 72 (depends on 60) 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. ### Claim 73 (depends on 60) 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. ### Claim 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. ### Claim 75 (depends on 74) 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. ### Claim 76 (depends on 74) The method of claim 74 wherein visualizing the tissue region of interest comprises imaging at least the portion of the airway. ### Claim 77 (depends on 74) The method of claim 74 wherein visualizing the tissue region of interest comprises imaging one or more nodules within the lung. ### Claim 78 (depends on 74) The method of claim 74 wherein conducting the vibration comprises imparting the vibration at a frequency of 0.5 to 50 Hz. ### Claim 79 (depends on 74) The method of claim 74 wherein visualizing the tissue region of interest comprises imaging the airway at a rate detectable by the imager. ### Claim 80 (depends on 79) The method of claim 79 wherein an imager frame rate is at least twice a frequency of the vibration. ### Claim 81 (depends on 74) The method of claim 74 wherein visualizing the tissue region of interest comprises obtaining an x-ray image of the tissue region of interest. ### Claim 82 (depends on 74) 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. ### Claim 83 (depends on 74) 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.