Patent Publication Number: US-2021169590-A1

Title: Systems and methods for navigational bronchoscopy and selective drug delivery

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     The present application is a continuation application of U.S. application Ser. No. 15/921,966, filed on Mar. 15, 2018, which claims the benefit of and priority to U.S. Provisional Application Ser. No. 62/512,764, filed on May 31, 2017, the entire contents of each of which being incorporated herein by reference. 
    
    
     FIELD 
     The present disclosure relates to surgical systems, and more particularly, to systems and methods for diagnosis, navigation, and localized treatment of lung conditions. 
     BACKGROUND 
     Tens of millions of people suffer from lung disease, such as emphysema, chronic obstructive pulmonary disease (“COPD”), asthma, interstitial lung disease, cystic fibrosis, cancer, pulmonary edema, or myriad other afflictions affecting the lungs. 
     As can be appreciated, trapped volumes of air, swelling, mucus, or other fluids in the lungs caused by lung disease make it difficult to effectively deliver inhaled medications to target sites deep within the lungs (e.g., bronchus, bronchioles, alveoli), which are often most in need of the medication, but are the least likely to receive it. Moreover, it is often difficult to immediately determine the efficacy of a particular medication after it has been administered to the patient. Therefore, a need exists for a diagnostic and a therapeutic bronchoscopy system for localized delivery of therapies and diagnostic agents within the lungs for treatment of lung disease. 
     SUMMARY 
     Provided in accordance with aspects of the present disclosure is a method for generating a three-dimensional (3D) model of a luminal network from a plurality of images and generating a navigational plan based on the 3D model to navigate to a target site within the luminal network. The method may include navigating, using the 3D model, a flexible elongate member including a therapeutic and diagnostic agent dispenser coupled thereto to the target site. The therapeutic and diagnostic agent dispenser may be configured to dispense aerosolized particles to treat the target site. The method may include administering the aerosolized particles from the therapeutic and diagnostic agent dispenser directly to the target site for absorption within the target site. 
     In an aspect of the present disclosure, the aerosolized particles are selected from the group consisting of liquids, gases, and gels. 
     In another aspect of the present disclosure, the method includes performing a scan selected from the group consisting of ventilation-perfusion (VQ), functional respiratory imaging, MRI, ultrasound, and computer tomography during a respiratory cycle to further refine the 3D model of the luminal network. 
     In yet another aspect of the present disclosure, administering the aerosolized particles includes delivering a time release therapeutic agent. 
     In still another aspect of the present disclosure, the method includes assessing the efficacy of the aerosolized particles using the 3D model of the luminal network. 
     In another aspect of the present disclosure, assessing the efficacy of the aerosolized particles includes comparing a pre-treatment 3D model of the luminal network with a post-treatment 3D model of the luminal network to determine a response to the aerosolized particles. 
     In yet another aspect of the present disclosure, the method includes selecting a therapeutic or diagnostic agent to deliver to the target site. 
     In still another aspect of the present disclosure, the method includes selecting a specific airway within a patient&#39;s lungs. 
     In still yet another aspect of the present disclosure, the method includes providing a bronchoscope having the therapeutic or diagnostic agent dispenser at a distal end thereof and inserting the bronchoscope and the therapeutic and diagnostic agent dispenser through a patient&#39;s nose and administering the aerosolized particles in an outpatient setting. 
     Provided in accordance with another aspect of the present disclosure is a system a display presenting one or images of a patient&#39;s lungs, a user interface presented on the display configured to present a three-dimensional (3D) model of a luminal network, wherein the 3D model is configured to assist a clinician in navigating to a target site within the luminal network. The system may further include a working channel navigable within the luminal network and a flexible elongate member and a therapeutic and diagnostic agent dispenser coupled thereto configured to dispense aerosolized particles to treat the target site, the flexible elongate member and the therapeutic and diagnostic agent dispenser configured for advancement through the working channel to deliver the aerosolized particles directly to the target site for absorption within the target site. 
     In an aspect of the present disclosure, the aerosolized particles are selected from the group consisting of liquids, gases, and gels. 
     In another aspect of the present disclosure, the therapeutic and diagnostic agent dispenser is an aerosol emitting device for deploying the aerosolized particles onto the target site. 
     In yet another aspect of the present disclosure, the therapeutic and diagnostic agent dispenser is an atomizer. 
     In still another aspect of the present disclosure, the therapeutic and diagnostic agent dispenser is a nebulizer. 
     In still yet another aspect of the present disclosure, each particle of the aerosolized particles is between 5 and 15 microns in diameter upon dispensation. 
     In another aspect of the present disclosure, the 3D model of the luminal network is formed from a computed tomography (CT) scan, the 3D model configured to be merged together with images from a second imaging modality to facilitate navigation through the lung&#39;s airways and to treat tissue. 
     In yet another aspect of the present disclosure, the user interface is configured to assess an efficacy of the aerosolized particles. 
     In still another aspect of the present disclosure, the user interface is configured to compare a pre-treatment 3D model of the luminal network with a post-treatment 3D model of the luminal network such that an efficacy of the aerosolized particles can be determined. 
     In still yet another aspect of the present disclosure, a therapeutic agent is selected from the group consisting of bronchidilators, corticosteroids, methylxanthines, beta-agonists, inhibitors, antimicrobials, antitumor agents, antifibrotic agents, biologic agents, immunotherapy, gene vectors, radio-labeled and auto fluorescing ligands. 
     In another aspect of the present disclosure, a diagnostic agent is selected from the group consisting of inorganic and organic compounds, dyes, stains, radioactive tracers, and culture-media chemical based constituents. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Objects and features of the presently disclosed system and method will become apparent to those of ordinary skill in the art when descriptions of various embodiments thereof are read with reference to the accompanying drawings, wherein: 
         FIG. 1  is a perspective schematical view of an electromagnetic navigation system in accordance with the present disclosure; 
         FIG. 2  is a partial perspective view showing the distal portion of a medical tool configured for use with the system of  FIG. 1 ; and 
         FIG. 3  is an illustration of a user interface of the workstation of  FIG. 1  presenting multiple views for navigating to a target site. 
     
    
    
     DETAILED DESCRIPTION 
     Provided in accordance with the present disclosure is a diagnostic and a therapeutic bronchoscopy system for localized delivery of therapies and diagnostic agents, medications, etc. within the lungs. One of the challenges of respiratory medicine is the delivery of inhaled agents or medications to precise locations to best identify or treat a variety of different lung diseases such as obstructive lung diseases, given the dynamic nature of respiration in the context of relatively limited system measures such as forced vital capacity (FVC) and the like. The primary mode of delivery remains through the oropharynx (i.e., the throat). For many reasons (e.g., swelling, mucus, trapped air, anatomy), the inhaled medications do not or cannot make it to the lower respiratory airways and thus, cannot provide effective treatment to the areas of the lungs that need it most. The described system provides a clinician with the ability to distribute a therapeutic or diagnostic agent or medication directly to a target site for ensured delivery and the ability to assess the efficacy of that agent or medication during both static as well as dynamic assessments and/or after a procedure. Specifically, the present disclosure discloses systems and methods for creating and fusing functional and anatomical maps of the lungs, diagnosing a condition within the lungs, generating a treatment plan for a target site within the airways or lungs, navigating to a target site, administering a therapeutic or diagnostic agent or treatment to the target site, and assessing the efficacy of the agent or treatment. These and other aspects and features of the present disclosure are detailed herein below. 
     Referring initially to  FIG. 1 , an illustration of an electromagnetic navigation (EMN) system  10  in accordance with the present disclosure is shown. The EMN system  10  may be used for planning and navigating a pathway to a target tissue site and delivering a therapeutic or diagnostic agent or dose of medication to the target site, as will be described in further detail below. EMN system  10  generally includes an operating table  40  configured to support a patient, a bronchoscope  50  configured for insertion through the patient&#39;s mouth and/or nose into the patient&#39;s airways, monitoring equipment  60  coupled to bronchoscope  50  for displaying video images received from bronchoscope  50 , a tracking system  70  including a tracking module  72 , a plurality of reference sensors  74 , an electromagnetic field generator  76 , and a workstation  80  including software and/or hardware used to facilitate pathway planning, identification of target tissue, and navigation to target tissue. EMN system  10  also includes a catheter assembly  90 , which is insertable into the working channel of bronchoscope  50 . As will be described in further detail below, catheter assembly  90  and other treatment tools may be inserted through bronchoscope  50  to navigate to and/or treat tissue. 
     As part of the planning phase, a series of pre-procedure images of the patient airways are obtained using one or more imaging modalities, such as computerized tomography (CT) scans, and used for planning and generating the pathway to the target. Generally, during imaging, the patient&#39;s breath is held during the CT scan thereby creating a single set of image slices (e.g., CT image data) based on either the peak inhalation or peak exhalation of a patient&#39;s respiratory cycle. The CT image data is then loaded onto workstation  80 , which utilizes the CT image data for generating and viewing a three-dimensional map or model of the patient&#39;s airways. The 3D model and image data derived from the 3D model enables the identification of the target tissue (automatically, semi-automatically or manually), and allows for the selection of a pathway through the patient&#39;s airways to the target tissue, which in fact may be the airways themselves. More specifically, the CT scans are processed and assembled into a 3D volume, which is then utilized to generate the 3D model of the patient&#39;s airways. Additionally, a more dynamic anatomic map of the airways can also be rendered in 3D using CT or other modalities in order to make an assessment of the airway tree and lung during normal tidal volume breathing such that targets, targeted treatment areas, etc., can be better identified. 
     The 3D model may be presented on a display monitor  81  associated with workstation  80 , or in any other suitable fashion. Using workstation  80 , various slices of the 3D volume and views of the 3D model may be presented and/or may be manipulated by a clinician to facilitate identification of the target tissue and selection of a suitable pathway through the patient&#39;s airways to access the target tissue. The 3D model may also show marks of the locations where previous biopsies were performed, including the dates, times, and other identifying information regarding the tissue samples obtained. These marks may also be selected as the target site to which a pathway can be planned. Once selected, the pathway is saved for use during the navigation procedure. The 3D model and real time images of the lungs are then merged together (similar to car GPS), to facilitate navigation through the lung&#39;s airways and to treat tissue. The 3D model can be updated based on dynamic feedback from, e.g., the treatment effect on the airways or lack thereof, the need for further treatment, additional diagnoses, under treated or over treated areas, or simply as a consequence of the merged image data determining where to direct the treatment for optimal clinical effect. The information generated from the 3D model described above can be used to develop a database such that 3D model, maps, and other patient data, may be optimized over time relative to the disease or affliction being targeted. 
     It should be appreciated that a patient&#39;s lungs may additionally or alternatively be imaged using any suitable imaging device, such as MRI, ultrasound, PET, and/or the like, and the images may be processed in combination with the software and programs stored on workstation  80 , described in greater detail below. 
     One example of an EMN system that generates 3-D models of airways and other luminal networks from CT image data is the ILOGIC® ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY® system, currently sold by Covidien LP. The details of such a system are described in the commonly assigned U.S. Pat. No. 7,233,820 filed on Mar. 29, 2004 to Gilboa and entitled ENDOSCOPE STRUCTURES AND TECHNIQUES FOR NAVIGATING TO A TARGET IN BRANCHED STRUCTURE, the contents of which are incorporated herein by reference. 
     During the planning phase, scan traceable particles may be administered to a patient to assess where the scan traceable particles ultimately disperse to in the lungs (e.g., the deposition pattern) and where the most functional lung and gas exchange occurs. Such an assessment may be performed, for example, by using functional respiratory imaging, ventilation-perfusion (VQ) scan, CT, MRI, ultrasound, PET, or a combination thereof, which can also create both dynamic and static maps. The dynamic and static maps may be overlaid and/or integrated with previous patient imaging (e.g., models, maps, etc.) to refine the 3D model. Inhaled medications, e.g., bronchodilators, antibiotics, etc., can then be used to evaluate potential alternations or changes from the previous patient models or maps, which can then be integrated into the treatment plan to refine the treatment plan therewith (e.g., identify over treated or under treated areas and treating such areas). In at least one embodiment, comparison of localized lung function and structural changes (e.g., diameter of airways) before and after administration can be utilized to assess where in the lungs the bronchodilator, tracer and/or other therapy reaches and locations requiring specialized treatment. When the bronchodilator, tracer and/or other therapy is administered in combination with scan traceable particles, the aerosolized deposition pattern at various points in the respiratory cycle may then be visible under imaging such as MRI, functional respiratory imaging, PET, V/Q scanning and the like. This imaging information may be used to further refine the 3-D imaging map of the patient&#39;s lungs or to determine which areas of the lungs are not receiving and/or are incapable of receiving medication (e.g., due to swelling, air or mucus build up, or other condition), and to identify locations for localized treatment using the procedures and devices described herein. 
     Referring still to  FIG. 1 , catheter guide assembly  90  usable with EMN system  10  is shown. Catheter guide assembly  90  includes a handle  91 , which is connected to an extended working channel (EWC)  96 . The EWC  96  is sized for placement into the working channel of bronchoscope  50  and allows for deep access into the lung. In operation, a locatable guide (LG)  92 , including an electromagnetic (EM) sensor  94 , is inserted into the EWC  96  and locked into position such that the sensor  94  extends a desired distance beyond the distal tip of the EWC  96 . In one embodiment, the LG  92  is integrated with the EWC  96  so the EM sensor  94  is disposed on the EWC  96 . The location of the EM sensor  94 , and thus the distal end of the EWC  96 , within an electromagnetic field generated by the electromagnetic field generator  76 , can be derived by the tracking module  72  and the workstation  80 . Catheter guide assembly  90  further includes a handle  91  that can be manipulated by rotation and compression to steer a distal tip  93  of the LG  92  and extended working channel (EWC)  96 . Catheter guide assembly  90  is currently marketed and sold by Medtronic, Inc. under the names SUPERDIMENSION® and EDGE™ Procedure Kits. For a more detailed description of catheter guide assembly  90 , reference may be made to commonly-owned U.S. Pat. No. 9,247,992 filed on Mar. 15, 2013 by Ladtkow et al., the entire contents of which are hereby incorporated by reference. 
     As illustrated in  FIG. 1 , the patient is shown lying on an operating table  40  with a bronchoscope  50  inserted through the patient&#39;s mouth and into the patient&#39;s airways. Bronchoscope  50  may include a source of illumination (not explicitly shown) and a video imaging system (not explicitly shown) and is coupled to monitoring equipment  60 , e.g., a video display, for displaying the video images received from the video imaging system of bronchoscope  50 . 
     Catheter guide assembly  90 , including LG  92  and EWC  96 , is configured for insertion through a working channel of bronchoscope  50  into the patient&#39;s airways (although the catheter guide assembly  90  may alternatively be used without bronchoscope  50 ). EM sensor  94  may be disposed directly on the EWC  96 , as described above. Additionally, or alternatively, EM sensor  94  may be disposed directly on or built into bronchoscope  50 , or fitted over the bronchoscope  50  in the form of an adapter (not shown). The sensor  94  may be disposed anywhere along the channel of the bronchoscope  50 . A six degrees-of-freedom (DOF) electromagnetic tracking system  70  may be used and may be similar to those disclosed in U.S. Pat. No. 6,188,355 and published PCT Application Nos. WO 00/10456 and WO 01/67035, the entire contents of each of which are incorporated herein by reference. Other configurations are also contemplated including a 5 DOF and 3 DOF system without departing from the scope of the present disclosure. Tracking system  70  is configured for use with catheter guide assemblies  90  to track the position of the EM sensor  94  as it moves in conjunction with the EWC  96  through the airways of the patient. 
     As shown in  FIG. 1 , electromagnetic field generator  76  is positioned beneath the patient. Electromagnetic field generator  76  and the plurality of reference sensors  74  are interconnected with tracking module  72 , which derives the location of each reference sensor  74  in six DOF. One or more of reference sensors  74  are attached to the chest of the patient. The six DOF coordinates of reference sensors  74  are sent to workstation  80 , which includes application  82  where sensors  74  are used to calculate a patient coordinate frame of reference. In practice, a clinician uses the catheter guide assembly  90  to navigate the EWC  96  and/or bronchoscope  50  using the EM sensor  94  to reach a target site from within the luminal network of the lungs (e.g., the airways). Once the target site is reached, another device, e.g., a medical tool, is inserted into the EWC  96  and/or bronchoscope  50  and advanced to the target site. 
     With reference to  FIG. 2 , the distal portion of a medical tool for use with the present disclosure is illustrated and generally identified by reference numeral  200 . Medical tool  200  includes a flexible elongate member  201 , a body  202 , a reservoir  203  filled with a therapeutic and diagnostic agent  204 , a lumen  205 , and a nozzle  206 . Medical tool  200  may be, e.g., a small atomizer or aerosolizer, which may be similar in design to an inhaler or nebulizer. Medical tool  200  may also be a liquid, gel, or gas dispensing device configured to dispense therapeutic and/or diagnostic agents. For example, in addition to dispensing therapeutic agents used to treat tissue, medical tool  200  may additionally or alternatively dispense diagnostic agents, e.g., radio-labeled ligands to identify an infection in a certain lung region or a marker that auto fluoresces when in contact with certain forms of lung injury just to name a few. 
     Flexible elongate member  201  is configured to be extendable within bronchoscope  50  or EWC  96 . Body  202  of medical tool  200  may be attached to a distal end portion of flexible elongate member  201 . A therapeutic agent  204  may be any of a variety of medication, including but not limited bronchidilators, corticosteroids, methylxanthines, beta-agonists, inhibitors, antimicrobials, antitumor agents, antifibrotic agents, biologic agents, immunotherapy, gene vectors, and radio-labeled and auto fluorescing ligands. A diagnostic agent  204  may be inorganic and organic compounds, dyes, stains, radioactive tracers, and culture-media chemical based constituents. Other suitable therapeutic and diagnostic agents known in the art are also contemplated and are configured for use with the medical tool  200  described herein. In embodiments, medical tool  200  is configured to dispense a therapeutic agent  204  and a diagnostic agent  204  together, or independently, as desired. In one example, the particles of the therapeutic and diagnostic agent  204  may utilize time release technology for timed or continuous drug delivery of the medication or drugs contained therein over an extended period time. In another embodiment, therapeutic and diagnostic agent  204  may be micro-particles. The micro-particles may be small enough such that they are not lodged within the luminal network of the lungs before reaching their target destination, but also large enough to traverse the alveoli of the lungs. For example, the micro-particles may be from 5-15 microns, although any suitable particle size is contemplated. In embodiments, if a sensor  94  is incorporated into or onto the bronchoscope  50 , the working channel of the bronchoscope  50  itself can then become the source of localized delivery for a diagnostic and/or therapeutic substance. 
     In use, medical tool  200  is inserted into EWC  96  and/or bronchoscope  50  and navigated through the lungs until nozzle  206  is proximate to the target site identified during the planning phase. Once nozzle  206  of medical tool  200  is proximate to the target site, medical tool  200  is actuated, upon which therapeutic and diagnostic agent  204  is released as, e.g., micro-particles, liquid, or the like, as shown in  FIG. 2 . It should be appreciated that medical tool  200  may employ a variety of technologies for accomplishing the release and dispersal of the therapeutic and diagnostic agent  204 . This may include one or more lumens extending to the proximal end of the flexible elongate member  201  for the injection of a medium for atomizing or aerosolizing therapeutic and diagnostic agent  204  (e.g., a propellant source). Alternatively, a mechanism may be incorporated to selectively release therapeutic and diagnostic agent  204  from reservoir  203 , where the reservoir  203  itself is pressurized. In such an embodiment, the reservoir  203  may be removable from medical tool  200 . Actuation of the selectively releasable mechanism may be accomplished from the proximal end of the medical tool  200  and may be mechanical, electrical, or a combination of the two. 
     The therapeutic and diagnostic agent  204  may be in the form of a gel or paste for highly localized treatment of an identified location, particularly where it is desirable that the therapeutic and diagnostic agent  204  not be widely dispersed or where longer-term adherence to the treatment area is desired. As will be understood by those of skill in the art, further mechanisms for localized application of therapeutic and diagnostic agent  204  may be employed without departing from the scope of the present disclosure. 
       FIG. 3  depicts a user interface that may be presented on display  81  ( FIG. 1 ) during a patient assessment and/or procedure to locally treat the airways of a patient. As shown in  FIG. 3 , in accordance with embodiments of the present disclosure, display  81  presents user interface  300  to the clinician with a number of views  302 ,  304 , and  306 , to assist the clinician in navigating locatable guide  92  and EWC  96  to assess and treat e.g., a target site  303 . User interface  300  may include a local view (3D map static)  302 , a bronchoscope view  304 , and a 3D map dynamic view  306 . Local view  302  may also present the clinician with a visualization of distal tip  93  of EWC  96 , EM sensor  94  of locatable guide  92 , and medical tool  200  as appropriate during navigation. Bronchoscope view  304  may present an actual real-time view of the patient&#39;s lungs, e.g., by using a camera (not shown) and a light source (not shown). Bronchoscope view  304  may be used in conjunction with views  302 ,  306  to navigate the luminal network of the lungs. 
     Additionally or alternatively, bronchoscope view  304  may be used to assess, in real time, the efficacy of a drug at the intended target site. For example, changes in the lungs and lung lobes, airway and blood vessel volume, or the like, may be measured, following application of therapeutic and diagnostic agent  204  ( FIG. 2 ), using bronchoscope view  304 . Other views may be presented without departing from the scope of the present disclosure. As EWC  96  and locatable guide  92  advance, each of the views  302 ,  304 , and  306  is updated to account for the change in location. 
     User interface  300  may additionally include distance indicator  308 , orientation indicator  310 , and respiratory cycle indicator  312  which provide feedback on distance to target site  303 , orientation with respect to target site  303 , and sufficient access to target site  303  during the respiratory cycle. In one embodiment, indicators  308 ,  310 ,  312  may alternate between two colors or two shapes depending on the distance and orientation. For example, and as stated herein, when the distance to target site  303  from distal tip  93  of EWC  96  is within the distance of interaction for medical tool  200 , distance indicator  308  may change color from red to green or change from an “X” to a check mark as an indicator that from the current location to target site  303 , medical tool  200  is capable of interacting. In addition, orientation indicator  310  may change based on the orientation of medical tool  200  with respect to target site  303  and the adequacy of medical tool  200  interacting with target site  303 . Respiratory cycle indicator  312  may provide audio feedback to the clinician indicating where in the respiratory cycle the patient is at any one time and during when a peak of respiration interaction with region of interest  303  is likely to occur. 
     In further embodiments, user interface  300  may include a tool suggestion window  320 . During the respiratory cycle, tracking system  70  may analyze the movement of the airways during both inhalation and exhalation and based on the movement of the airway and the movement of target site  303 . User interface  300  may provide with suggestion interface window  320 , a specific medical tool  200  (including a specific therapeutic agent) or other tools, which are useful based on movement during the respiratory cycle, the specific assessment and/or procedure, and other characteristics that may be affected by the respiratory cycle. In further embodiments, user interface  300  may also provide a display of a confidence rating of interacting with target site  303 , detailing the percentage likelihood of interacting with target site  303 . 
     In use, the functional respiratory map of user interface  300  may be used to navigate, assess, and treat a target site. Initially, during the planning phase, the 3D map static view  302  and/or 3D map dynamic view  306  are used to make an assessment of a condition. For example, as described above, a user may perform a VQ scan and utilize user interface  300  to make a real time assessment as to where inhaled particles ultimately disperse to in the lungs (e.g., the deposition pattern) and where the most functional lung and gas exchange occurs. Using this and/or other methods, a clinician may then determine where to concentrate treatment, what treatment to use, and how much treatment to use, e.g., on target site  303 . Once the target site  303  is identified, using the planned procedure, a clinician may insert medical tool  200  into EWC  96  and/or bronchoscope  50  and advance it to target site  303  following a pathway depicted in the bronchoscope view  304  and the dynamic 3D map view  302  follow the plan to arrive at a target site  303 . When medical tool  200  is proximate to target site  303 , a clinician may activate medical tool  200  such that therapeutic and diagnostic agent  204  is dispensed from nozzle  206  to treat target site  303  directly. 
     It should be appreciated that delivering a medication directly to target site  303  will enable a clinician to, e.g., better treat target site  303 , better assess the true efficacy of a particular medication, and to save medication. Moreover, delivering, e.g., therapeutic and diagnostic agent  204  directly to target site  303  utilizing user interface  300  allows a clinician to assess, in real-time, the efficacy of any particular medication. After treatment, a clinician may perform another CT scan to generate a post-treatment 3D model of the patient&#39;s lungs, which can then be compared with the pre-treatment data of the patient&#39;s lungs to assess the efficacy of the treatment. Specifically, utilizing user interface  300 , a clinician can measure the therapeutic responses to the treatment, e.g., the measured changes from pre and post-treatment data, such as, for example, changes in the lungs and lung lobes, airway and blood vessel volume, measures of flow both with respect to the entire system as well as specific areas of the system, for example, the right upper lobe, the left upper lobe, etc. 
     In an alternative embodiment, a therapeutic and diagnostic agent  204  may be administered in a simplified outpatient assessment and/or procedure. A clinician may insert bronchoscope  50  (e.g., a pediatric bronchoscope) and/or EWC  96  down a patient&#39;s mouth or nose. A clinician may then manipulate bronchoscope  50  and/or EWC  96  until the desired target site in the lungs is reached. A camera (not shown) or light source (not shown) may be used to navigate the lungs to the intended target site. Medical tool  200  may then be advanced down bronchoscope  50  and/or EWC  96  until nozzle  206  is proximate to the target site, upon which medical tool may be activated to dispense therapeutic and diagnostic agent  204  onto the intended target site. The bronchoscope  50  and/or EWC  96  may then be navigated to a target site in the airways or lung parenchyma. This assessment and/or procedure may be automated relative to the sequence of airways or targets that need to be treated and in addition, to the type of therapeutic and diagnostic agents assigned to a particular target. The treatment may be based initially on pre-treatment assessment of the parenchyma and airway tree as well as by using a data base to further enhance selection and accuracy. In addition, follow up treatments may then also be based on how a patient responded to the previous treatment, which data can then be integrated into the next treatment plan. The data can be used to develop a database to optimize patient treatment over time relative to the disease or affliction being targeted. 
     Thus, the presently described embodiment ensures delivery of therapeutic and diagnostic agent  204  to the target site in an efficient, simplified outpatient assessment and/or procedure. 
     Detailed embodiments of devices, systems incorporating such devices, and methods using the same have been described herein. However, these detailed embodiments are merely examples of the disclosure, which may be embodied in various forms. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for allowing one skilled in the art to employ the present disclosure in virtually any appropriately detailed structure. While the preceding embodiments were described in terms of bronchoscopy of a patient&#39;s airways, those skilled in the art will realize that the same or similar devices, systems, and methods may be used in other luminal networks, such as, for example, the vascular, lymphatic, and/or gastrointestinal networks as well.