Apparatuses and methods for endobronchial navigation to and confirmation of the location of a target tissue and percutaneous interception of the target tissue

Abstract

A method of confirming the location of a target tissue within a patient using a navigation system is provided. The navigation system displays images from a pre-acquired image dataset and provides location information of a medical device within a patient in relation to a patient tracking device affixed to the patient. The method includes determining an initial location of the target tissue, navigating a steerable catheter through the airway of the patient to a position proximate the initial location, tracking the location of the steerable catheter in the airway using the navigation system, generating information regarding the presence of the target tissue using a tissue sensing device inserted into the steerable catheter, and determining a confirmed location of the target tissue in relation to the patient tracking device using the generated information regarding the presence of the target tissue and the tracked location of the steerable catheter.

1 . A method of confirming the location of a target tissue within a patient using a navigation system, the navigation system comprising a localization device, an electromagnetic field generator, a display, and a pre-acquired image dataset of an airway of the patient, the navigation system being adapted to display images from the image dataset and to provide location information of a medical device within the patient in relation to a patient tracking device comprising a plurality of localization elements, the method comprising:
 affixing the patient tracking device to an external surface of the patient;   tracking the location of the patient tracking device using the navigation system;   displaying an image from the image dataset on the display, wherein the displayed image is registered to the patient tracking device;   determining an initial location of the target tissue in the image dataset;   navigating a steerable catheter through the airway of the patient to a position proximate the initial location, the steerable catheter having a proximal end portion and a distal end portion terminating in a tip, a working channel extending there between, and a localization element disposed proximate the distal end portion thereof;   tracking the location of the localization element of the steerable catheter in the airway using the navigation system;   generating information regarding the presence of the target tissue using a tissue sensing device inserted into the working channel of the steerable catheter;   determining a confirmed location of the target tissue in relation to the patient tracking device using the generated information regarding the presence of the target tissue and the tracked location of the localization element;   recording the confirmed location of the target tissue; and   displaying the confirmed location of the target tissue on the display of the navigation system in an image from the image dataset.   
     
     
         2 . The method of  claim 1  wherein during the step of displaying an image from the image dataset on the display, the displayed image is displayed as a function of the monitored respiratory state. 
     
     
         3 . The method of  claim 1  wherein recording the confirmed location of the target tissue comprises recording four-dimensional data comprising a three-dimensional location of the confirmed target tissue in relation to the patient tracking device and the respiratory state of the patient at the time the location of the target tissue was confirmed and applying the confirmed location of the target tissue to an image from the image dataset depicting the airway at the respiratory state of the patient at the time the location of the target tissue was confirmed. 
     
     
         4 . The method of  claim 3 , wherein the respiratory state of the patient is monitored using the patient tracking device. 
     
     
         5 . The method of  claim 1  wherein recording the confirmed location of the target tissue comprises recording four-dimensional data comprising a three-dimensional location of the confirmed target tissue in relation to the electromagnetic field generator and the respiratory state of the patient at the time the location of the target tissue was confirmed and applying the confirmed location of the target tissue to an image from the image dataset depicting the airway at the respiratory state of the patient at the time the location of the target tissue was confirmed. 
     
     
         6 . The method of  claim 5 , wherein the respiratory state of the patient is monitored using the patient tracking device. 
     
     
         7 . The method of  claim 1  wherein recording the confirmed location of the target tissue comprises recording a three-dimensional location of the confirmed target tissue in relation to the patient tracking device. 
     
     
         8 . The method of  claim 1  wherein recording the confirmed location of the target tissue comprises recording a three-dimensional location of the confirmed target tissue in relation to the electromagnetic field generator. 
     
     
         9 . The method of  claim 1  wherein recording the confirmed location of the target tissue comprises recording four-dimensional data comprising a three-dimensional location of the confirmed target tissue in relation to the patient tracking device and a cardiac state of the patient at the time the location of the target tissue was confirmed. 
     
     
         10 . The method of  claim 1  wherein recording the confirmed location of the target tissue comprises recording four-dimensional data comprising a three-dimensional location of the confirmed target tissue in relation to the electromagnetic field generator and a cardiac state of the patient at the time the location of the target tissue was confirmed. 
     
     
         11 . The method of  claim 1  wherein during the step of displaying the confirmed location of the target tissue on the display of the navigation system in an image from the image dataset, the displayed image depicts the airway at the respiratory state of the patient at the time the location of the target tissue was confirmed. 
     
     
         12 . The method of  claim 11 , wherein the respiratory state of the patient is monitored using the patient tracking device. 
     
     
         13 . The method of  claim 1  wherein the tissue sensing device comprises an imaging device and the generating information regarding the presence of the target tissue comprises generating one or more of images of the target tissue using the imaging device inserted into the working channel of the steerable catheter. 
     
     
         14 . The method of  claim 13  wherein the imaging device comprises one or more of: a bronchoscopic video camera, an endobronchial ultrasound (EBUS) device, an optical coherence tomography (OCT) device, and a probe based Confocal Laser Endomicroscopy (pCLE) device. 
     
     
         15 . The method of  claim 1  wherein the tissue sensing device comprises one or more of: a cell analysis device, a cancer detecting device, an exhaled breath condensate analyzer, a physiological characteristic sensor device, a chemical analysis device, and an aromatic hydrocarbon detection device. 
     
     
         16 . The method of  claim 1  wherein a bronchoscopic video camera is inserted into the working channel of steerable catheter and wherein the bronchoscopic video camera generates a real-time image feed of the airway as the steerable catheter is being navigated through the airway and wherein the method further comprises displaying the real-time image feed on the display of the navigation screen. 
     
     
         17 . The method of  claim 16  further comprising overlaying one or more navigational aids onto the real-time image feed, wherein the navigational aids are registered to the real-time image feed. 
     
     
         18 . The method of  claim 17  wherein the navigational aids comprise one or more of a navigation pathway and a directional cue. 
     
     
         19 . The method of  claim 16  further comprises:
 displaying a virtual volumetric scene of the airway on the display of the navigation system; and 
 registering the real-time image feed and the virtual volumetric scene. 
 
     
     
         20 . The method of  claim 19  further comprising maintaining registration of the virtual volumetric scene to the real time image feed as the steerable catheter is navigated through the airway of the patient. 
     
     
         21 . The method of  claim 19  further comprising overlaying one or more navigational aids onto the real-time image feed. 
     
     
         22 . The method of  claim 21  wherein the navigational aids comprise one or more of a navigation pathway and a directional cue. 
     
     
         23 . The method of  claim 1  further comprising the steps of:
 displaying on the display of the navigation system a trajectory of a percutaneous device from an entry point on the patient to the confirmed location, the percutaneous device comprising a localization element; 
 inserting the percutaneous device into the patient; 
 navigating the percutaneous device to the confirmed location; and 
 intercepting the target tissue at the confirmed location. 
 
     
     
         24 . The method of  claim 23  wherein the percutaneous device comprises a percutaneous needle having a cannula including a proximal end portion and a distal end portion terminating in a tip, a working channel extending there between, and wherein the localization element is disposed proximate the distal end portion thereof. 
     
     
         25 . The method of  claim 23  wherein the percutaneous device comprises a thoracic wedge resection device and intercepting the target tissue comprises performing a thoracic wedge resection of the target tissue. 
     
     
         26 . The method of  claim 23  wherein the percutaneous device comprises a biopsy gun. 
     
     
         27 . The method of  claim 23  further comprising:
 generating one or more images of at least a portion of the percutaneous device at the confirmed location of the target tissue using an imaging device inserted into the working channel of the steerable catheter. 
 
     
     
         28 . The method of  claim 24  wherein intercepting the target tissue at the confirmed location of the target tissue comprises:
 inserting a biopsy device into the working channel of the percutaneous needle; and 
 extending the biopsy device beyond the tip of the percutaneous needle to sample the target tissue. 
 
     
     
         29 . The method of  claim 28  further comprising:
 generating one or more images of the biopsy device sampling the target tissue using an imaging device inserted into the working channel of the steerable catheter. 
 
     
     
         30 . The method of  claim 24  wherein intercepting the target tissue at the confirmed location of the target tissue comprises:
 inserting a therapy device into the working channel of the percutaneous needle; and 
 delivering therapy to the target tissue. 
 
     
     
         31 . The method of  claim 30  further comprising:
 generating one or more images of the therapy device delivering therapy to the target tissue using an imaging device inserted into the working channel of the steerable catheter. 
 
     
     
         32 . The method of  claim 30  wherein the therapy device is an ablation probe and the method further comprises displaying ablation models on the display of the navigation system at the confirmed location of the target tissue. 
     
     
         33 . The method of  claim 23  further comprising:
 generating one or more images of anatomical structures proximate the confirmed location of the target tissue using an imaging device inserted into the working channel of the steerable catheter; 
 confirming the location of the anatomical structures in relation to the patient tracking device using the generated images and the tracked location of the inserted steerable catheter; 
 recording the confirmed location of the anatomical structures in relation to the patient tracking device. 
 
     
     
         34 . The method of  claim 33  further comprising:
 calculating a trajectory from the confirmed location of the target tissue to a corresponding entry point on the patient wherein the trajectory avoids some or all of the anatomical structures. 
 
     
     
         35 . The method of  claim 34  wherein the anatomical structures comprise one or more of: bone, the heart, the liver, other organs, fissures, diseased tissue, COPD lung tissue, and blood vessels. 
     
     
         36 . The method of  claim 34  wherein the calculated trajectory is the shortest distance from the confirmed location of the target tissue to a corresponding calculated entry point on the patient. 
     
     
         37 . The method of  claim 34  further comprising displaying the calculated trajectory from the confirmed location of the target tissue to the corresponding calculated entry point on the patient. 
     
     
         38 . The method of  claim 34  wherein displaying a trajectory of the percutaneous device relative to the confirmed location of the target tissue on the display of navigation system further comprises displaying an extended trajectory of a medical device, wherein the medical device may be disposed in the working channel of the percutaneous needle and may be extended beyond the tip of the percutaneous needle, and wherein the extended trajectory displays the potential extension of the medical device so that it may be confirmed that the extension will sample the target tissue and will not hit one or more anatomical structures. 
     
     
         39 . The method of  1  further comprising:
 matching an atlas model to the image dataset of the airway of the patient, the matching comprising deforming the atlas model to the image dataset of the airway of the patient, wherein the atlas model comprises anatomical structures; 
 identifying anatomical structures to be avoided by the trajectory of a percutaneous device; and 
 calculating a trajectory from the confirmed location of the target tissue to the corresponding entry point on the patient wherein the trajectory avoids some or all of the anatomical structures. 
 
     
     
         40 . The method of  claim 39  wherein the anatomical structures comprise one or more of: bone, the heart, the liver, other organs, fissures, diseased tissue, COPD lung tissue, and blood vessels. 
     
     
         41 . The method of  claim 39  wherein the calculated trajectory is the shortest distance from the confirmed location of the target tissue to a corresponding calculated entry point on the patient. 
     
     
         42 . The method of  claim 39  further comprising displaying the calculated trajectory from the confirmed location of the target tissue to the corresponding calculated entry point on the surface of the patient. 
     
     
         43 . The method of  claim 42  further comprising indicating a procedural position in which the patient must be to navigate the percutaneous needle along the calculated trajectory from the confirmed location of the target tissue to the corresponding calculated entry point on the patient. 
     
     
         44 . The method of  claim 39  further comprising:
 navigating a needle connected to a robotic medical device to the calculated entry point on the surface of the patient; 
 inserting the needle into the patient at the calculated entry point on the surface of the patient; and 
 extending the needle to the confirmed location of the target tissue along the calculated trajectory. 
 
     
     
         45 . A method of navigating a percutaneous needle to a target tissue within a patient using a navigation system, the navigation system comprising a localization device, an electromagnetic field generator, a display, and a pre-acquired image dataset of an airway of the patient, the navigation system being adapted to display images from the image dataset and to provide location information of a medical device within a patient in relation to a patient tracking device comprising a plurality of localization elements, the method comprising:
 affixing the patient tracking device to an external surface of the patient;   tracking the location of the patient tracking device using the navigation system to monitor the respiratory state of the patient;   displaying an image from the image dataset on the display as a function of the monitored respiratory state, wherein the displayed image is registered to the patient tracking device;   determining an initial location of the target tissue in the image dataset;   navigating a steerable catheter through the airway of the patient to a position proximate the initial location, the steerable catheter having a proximal end portion and a distal end portion terminating in a tip, a working channel extending there between, and a localization element disposed proximate the distal end portion thereof;   tracking the location of the localization element of the steerable catheter in the airway using the navigation system;   generating one or more images of the target tissue using an imaging device inserted into the working channel of the steerable catheter;   determining a confirmed location of the target tissue in relation to the patient tracking device using the generated images and the tracked location of the localization element;   recording the confirmed location of the target tissue, the recording comprising four-dimensional data comprising a three-dimensional location of the confirmed target tissue in relation to the patient tracking device and the respiratory state of the patient at the time the location of the target tissue was confirmed and applying the confirmed location of the target tissue to an image from the image dataset depicting the airway at the respiratory state of the patient at the time the location of the target tissue was confirmed;   displaying the confirmed location of the target tissue on the display of the navigation system in an image from the image dataset, the displayed image depicting the airway at the respiratory state of the patient at the time the location of the target tissue was confirmed;   displaying a trajectory of a percutaneous device from an entry point on the patient's body to the confirmed location on the display of the navigation system, the percutaneous device comprising a localization element;   inserting the percutaneous device into the patient and navigating the percutaneous device to the confirmed location; and   intercepting the target tissue at the confirmed location.