Abstract:
Systems, devices and methods for selectively blocking respiratory air flow to portions of a lung are disclosed. For example, one bronchus of a lung may be sealed off while another bronchus remains open to air flow. An endobronchial blocker may comprise an at least substantially transparent elongate member configured to facilitate real-time monitoring of the position of an inflatable member of the endobronchial blocker throughout a surgical procedure using a visualization or imaging device inserted within a main lumen of the endobronchial blocker.

Description:
FIELD 
       [0001]    The embodiments described herein generally relate to the ability to selectively ventilate one lung or portion thereof during ventilation of a patient through an endotracheal tube or other body-inserted medical tube. 
       BACKGROUND 
       [0002]    Ventilation of a patient through a single-lumen endotracheal tube results in essentially equal ventilation of both lung fields simultaneously. There are instances when it may be clinically advantageous to be able to ventilate only one lung at a given time. For example, the most common clinical situation when ventilation of only one lung is desired is during thoracic surgery (either open or thoracoscopic), in which, for visualization and technical reasons, it may be necessary to cease ventilation to the lung that is being operated upon. A less common clinical situation can occur when there is pathology in one lung (such as excessive air leak, hemorrhage, or infection) that needs to be mechanically isolated from the normally-functioning lung. 
         [0003]    There are currently two main options for single-lung isolation during ventilation. The first option is the use of a double-lumen endotracheal tube, where one lumen of the endotracheal tube is placed into either the right or left main stem bronchus and a balloon is inflated within that bronchus. Subsequently, at the discretion of the clinician, ventilation can be accomplished utilizing only the lung whose main stem was intubated, using only the other lung whose main stem was not intubated, or through a Y-connector that allows ventilation of both lungs. Double-lumen endotracheal tubes can be somewhat stiff and difficult to position. Appropriate positioning can be assessed either through indirect clinical measurements, such as breath sounds, or utilizing a pediatric-size bronchoscope to visually verify its correct placement. The stiffness and size of these double-lumen endotracheal tubes has been associated with bronchial mucosal injury, such as hemorrhage. Once the double-lumen tube is confirmed in position and the surgical procedure is underway, possible dislodgement or other difficulties with ventilation require reinserting a bronchoscope, often with the patient not in a favorable anatomic position, to try to reposition the double-lumen tube. 
         [0004]    The second option for single-lung isolation during ventilation is to use a bronchial blocker. In its simplest form, the bronchial blocker is a balloon catheter that is placed through a single-lumen endotracheal tube and then into either the right or left main stem bronchus. Once the balloon is inflated, ventilation only occurs in the opposite lung. Usually, the bronchial blocker is placed utilizing a bronchoscope which, since the bronchoscope and bronchial blocker are both within the endotracheal tube, can cause temporary airway obstruction or difficulty in ventilating the patient. 
       SUMMARY 
       [0005]    In accordance with several embodiments, an endobronchial blocker is provided having an outer diameter of approximately 3 mm and having its own reversibly-coupled visualization system. In various embodiments, the reversibly-coupled visualization system advantageously allows the blocker to: i) be placed under direct vision without obstruction of a single-lumen endotracheal tube, ii) confirm appropriate expansion and seating within the chosen main stem bronchus, and/or iii) when pulled back proximal of a balloon of the blocker, can be left in place and used in real-time fashion to monitor the position of the blocker throughout the entire surgical procedure. In some embodiments, the visualization system is not an integral part of the endotracheal tube and can be moved separately from the endotracheal tube itself. 
         [0006]    In accordance with several embodiments, the endobronchial blocker described herein is designed to be used with the visualization and/or cleaning devices and systems described in one or more of the following patent applications, each of which is hereby incorporated herein by reference: WIPO Publ. No. WO 2013/063520, published on May 2, 2013 and U.S. Provisional Application No. 61/733,371, filed Dec. 4, 2012. For example, the embodiments of endobronchial blockers described herein may be used in conjunction with the adapters or coupling members (e.g., adapters or coupling members  121 ,  2400 ,  2400 ′,  2421 ,  2422 ,  2440 ,  2500 ,  2555 ) described in WIPO Publ. No. WO 2013/063520. 
         [0007]    In accordance with several embodiments, a system configured to selectively block respiratory air flow to a lung is provided. In one embodiment, the system comprises an elongate member (e.g., catheter) having a proximal end and a distal end and a central lumen extending from the proximal end to the distal end. In one embodiment, the proximal end of the elongate member is open and the distal end of the elongate member is closed or sealed off to outside air. The distal end of the catheter may comprise a window configured to facilitate visualization beyond the window. In one embodiment, the catheter comprises an inflatable member (e.g., balloon) positioned along a distal portion of the catheter. The catheter may comprise a pilot or inflation channel within a wall of the catheter surrounding the central lumen configured to facilitate inflation and deflation of the inflatable member. In one embodiment, the system comprises a retention assembly configured to exert a force on a visualization device (e.g., scope) inserted within the central lumen of the catheter to cause a distal end of the visualization device to be pressed against, or in close proximity to, the window at the distal end of the catheter. Non-inflatable expandable members may be used in other embodiments. 
         [0008]    In one embodiment, the catheter comprises a sheath along at least a portion of its length. At least a portion of the sheath of the catheter (e.g., a distal-most portion, such as the distal 1-6 cm, 0.5 cm-1 cm, 1 cm-4 cm, 1.5 cm-5 cm, 2 cm-8 cm, 3 cm-6 cm, 4 cm-10 cm) may be substantially transparent to allow for visualization outside of the wall of the catheter. In one embodiment, the entire sheath is at least substantially optically transparent or clear. 
         [0009]    In some embodiments, the system comprises an inflation control member at a proximal end of the catheter (e.g., to control inflation of a balloon disposed on the catheter). In one embodiment, the catheter comprises a second channel (e.g., auxiliary channel) within the wall of the catheter surrounding the central lumen. The second channel may comprise a distal opening or exit distal to the inflatable member (e.g., balloon) and proximal to the window or closed distal tip of the catheter to facilitate delivery of air and/or fluids to an airway of a patient through the second channel. 
         [0010]    In some embodiments, the system comprises a visualization device (e.g., visualization scope) configured to be inserted within the central lumen of the catheter. In one embodiment, the system comprises a multi-port connector with two, three, four or more ports configured to be coupled to a proximal end of an endotracheal tube or other body-inserted tube. The catheter may be configured to be inserted within a port of the multi-port connector, through the endotracheal tube, and advanced to a location within a bronchus of a lung. In one embodiment, the system comprises a compression member (e.g. compression cap) that is configured to be coupled to the port of the multi-port connector that the visualization device is inserted within to provide compression of the visualization device within the catheter. In one embodiment, the compression member comprises a flexible diaphragm, gasket, O-ring and/or other seal member configured to receive the catheter. The diaphragm or other seal member may be configured to seal or otherwise close down around and conform to an outer diameter of the catheter. The compression member may be configured to exert a compressive force on the catheter to inhibit axial or rotational movement of the catheter once the catheter is in a desired position. The retention assembly may comprise a retention member configured to engage with or couple to a corresponding member on the visualization device (e.g., a notch, slot, groove, recess, protrusion, ring, detent, loop, adhesive member) and an elastomeric sleeve configured to stretch to facilitate engagement with the corresponding member and exert a returning force as a result of the tendency to return to a relaxed, non-stretched state. 
         [0011]    In accordance with several embodiments, a method for selectively blocking respiratory air flow through an endotracheal tube to one of a patient&#39;s lungs is provided. In one embodiment, the method comprises providing an endobronchial blocker such as the endobronchial blockers described herein. In one embodiment, the method comprises coupling an endotracheal tube adapter having at least two inlet ports to an endotracheal tube within an intubated patient and inserting a visualization device within the central lumen of the endobronchial blocker. In one embodiment, the method comprises advancing a distal end of the visualization device to the distal end of the endobronchial blocker. 
         [0012]    In one embodiment, the method comprises inserting the endobronchial blocker within a first inlet port of the two inlet ports and causing the retention assembly to exert the force on the visualization device by coupling a retention member of the retention assembly to the visualization device. In one embodiment, the method comprises advancing the distal end of the endobronchial blocker within one of the lungs of the patient. The method may comprise confirming the positioning of the distal end of the endobronchial blocker using the visualization device. In one embodiment, the method comprises uncoupling the visualization device from the retention assembly and withdrawing the visualization device past a proximal end of the inflatable balloon of the endobronchial blocker. In one embodiment, the method comprises inflating the inflatable balloon to occlude the lung or portion thereof and confirming proper inflation and positioning of the inflatable balloon using the visualization device. 
         [0013]    In some embodiments, the method comprises coupling a ventilator to a second inlet port of the two inlet ports. The method may comprise recording an image of the position of the inflatable balloon within a bronchus. In one embodiment, the method comprises aspirating the airway beyond the inflatable balloon through a second channel within the wall of the catheter and/or insufflating the airway beyond the inflatable balloon through a second channel within the wall of the catheter. 
         [0014]    In some embodiments, the method comprises inserting a suction catheter through a third inlet port of the endotracheal tube adapter. In one embodiment, the method comprises inserting a fiberoptic bronchoscope through a third inlet port of the endotracheal tube adapter. In accordance with several embodiments, the method is performed without obstruction of the endotracheal tube or other body-inserted tube. In some embodiments, the method comprises coupling a compression member to the catheter configured to exert a compressive force on the catheter to inhibit axial or rotational movement of the catheter once the catheter is in a desired position. In various embodiments of methods, certain steps may be performed in a different order and/or may be optional. 
         [0015]    For purposes of summarizing the disclosure, certain aspects, advantages and novel features of embodiments of the inventions have been described herein. It is to be understood that not necessarily all such advantages can be achieved in accordance with any particular embodiment of the inventions disclosed herein. Thus, the embodiments disclosed herein can be embodied or carried out in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other advantages as can be taught or suggested herein. 
         [0016]    The methods summarized above and set forth in further detail below describe certain actions taken by a practitioner; however, it should be understood that they can also include the instruction of those actions by another party. For example, actions such as “inflating a balloon” include “instructing the inflating of a balloon.” Further aspects of embodiments of the invention will be discussed in the following portions of the specification. With respect to the drawings, elements from one figure may be combined with elements from the other figures. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0017]    Several embodiments of the inventions disclosed herein will be more fully understood by reference to the following drawings which are for illustrative purposes only: 
           [0018]      FIG. 1A  illustrates an embodiment of a tri-port connector that is advantageously designed to be used in conjunction with embodiments of the endobronchial blocker described herein. 
           [0019]      FIG. 1B  schematically illustrates the tri-port connector of  FIG. 1A  with the endobronchial blocker inserted through one of the ports of the tri-port connector. 
           [0020]      FIGS. 2A and 2B  schematically illustrate various views of an embodiment of a compression mechanism of the endobronchial blocker. 
           [0021]      FIG. 2C  illustrates a side view of an alternative embodiment of a compression mechanism of the endobronchial blocker. 
           [0022]      FIG. 3  illustrates an embodiment of a retention mechanism of the endobronchial blocker. 
           [0023]      FIGS. 4A and 4B  schematically illustrate an embodiment of a distal end of the endobronchial blocker. 
           [0024]      FIG. 5  illustrates an embodiment of a proximal end of the endobronchial blocker. 
           [0025]      FIG. 6  illustrates an embodiment of a ventilation port of the tri-port connector of  FIGS. 1A and 1B . 
           [0026]      FIGS. 7 and 7A  illustrate a configuration of caps covering a main port of the tri-port connector of  FIGS. 1A and 1B . 
           [0027]      FIGS. 8 and 8A  illustrate a configuration of caps for the port of the tri-port connector of  FIGS. 1A and 1B  into which the endobronchial blocker is inserted. 
           [0028]      FIGS. 9A and 9B  illustrate an embodiment of the entire endobronchial blocker  120  in two different states of use. 
       
    
    
     DETAILED DESCRIPTION 
       [0029]      FIG. 1A  schematically depicts an embodiment of a tri-port connector  100  that is advantageously designed to work in conjunction with embodiments of the endobronchial blockers described herein. In accordance with some embodiments, the tri-port connector  100  comprises one or more features of the adapters, connectors or coupling members (e.g., adapters or coupling members  121 ,  2400 ,  2400 ′,  2421 ,  2422 ,  2440 ,  2500 ,  2555 ), such as, e.g., those described in WIPO Publ. No. WO 2013/063520, the entire content of which is incorporated herein by reference. In some embodiments, the tri-port connector  100  includes three ports and a universal endotracheal tube coupling member; however, in other embodiments, the connector  100  includes fewer ports (e.g., two ports) or more ports (e.g., four ports, five ports, greater than five ports, etc.). The first port can include an oxygen port adapter  101  having an optional cap  102  and a tether  103  to a main manifold  104  of the tri-port connector  100 . The first port of the tri-port connector  100  may also include a ventilator connection site  105  that becomes available when the oxygen port adapter  101  is removed. 
         [0030]    The second port of the tri-port connector  100  is a main manifold port  106 , which may also optionally include a cap  107 . The main manifold port  106  can be configured to receive an intubation and/or cleaning system having visualization or imaging capabilities or functions (such as, for example, components of the visualization devices  120  or visualization device assembly  2521  or cleaning systems described in WIPO Publ. No. WO 2013/063520, the entire content of which is incorporated herein by reference) and/or a cap-insert configured to allow suctioning, fiberoptic bronchoscopy or endoscopy, or other instrumentation of the tracheobronchial tree or other anatomical features during an operation or procedure. 
         [0031]    In some embodiments, the third port of the tri-port connector  101  comprises a manifold port  108  through which a stylet (e.g., malleable stylet), obturator or other device can be placed (for example, at the time of intubation). The manifold port  108  can optionally include a cap  109  or similar seal member. In some embodiments, the tri-port connector  100  further includes a universal connection port  111  that connects the tri-port connector  100  to the proximal portion of standard endotracheal tubes or other medical tubes (e.g., tracheostomy tubes). As shown, the tri-port connector  100  may include one-way valves  110  (e.g., “duckbill” valves or flap valves), diaphragms, seals or other flow (e.g., backflow) prevention members that maintain positive pressure within the main manifold  104  (and ventilator circuit) when no devices are in place through the valves  110 . 
         [0032]      FIG. 1B  schematically illustrates the tri-port connector  100  with a portion of an embodiment of an endobronchial blocker  120  inserted through the manifold port  108 . In some embodiments, the endobronchial blocker  120  is inserted through the manifold port  108  after removal of a malleable stylet or obturator (e.g., used during intubation). The one way valve  110 A within the manifold port  108  is displaced by a catheter portion  121  of the endobronchial blocker  120  when inserted.  FIG. 1B  also illustrates an embodiment of a compression cap  122  that is configured to be coupled to the manifold port  108 . The compression cap  122  is configured to provide a compression site on a portion (e.g., visualization device and sheath assembly) of the blocker  120  so as to maintain the position of the blocker  120  (e.g., prevent or restrict longitudinal movement), as well as to maintain compression of a visualization device (e.g., fiber optic camera scope) within the blocker  120  so that the visualization device does not rotate within a surrounding sheath of the blocker  120 . The compression features of the compression cap  122  are illustrated and described in more detail in connection with  FIGS. 2A-2C . In some embodiments, the compression cap  122  comprises a soft and/or flexible diaphragm  124 , valve or other seal member through which the catheter portion  121  of the blocker  120  can be placed. In one embodiment, the diaphragm  124  may advantageously prevent, or reduce the likelihood of, loss of positive pressure from the manifold  104  (and ventilatory circuit) while the endobronchial blocker  120  is in place. 
         [0033]      FIGS. 2A and 2B  illustrate front and side views, respectively, of an embodiment of the compression cap  122  of  FIG. 1B . The compression cap  122  may be configured to be coupled to an endobronchial insertion port (e.g., manifold port  108 ) of a multi-port connector (e.g., tri-port connector  100 ). In some embodiments, the compression cap  122  is configured to receive, engage with and/or couple to an elastomeric and/or compressible sheath  125 , inside of which a visualization device can be inserted (not shown). In some embodiments, the elastomeric and/or compressible sheath  125  comprises a portion of the catheter portion  121  of the endobronchial blocker  120 . The visualization device can comprise a fiber optic camera scope or any other type of scope (e.g., bronchoscope, endoscope) or visualization/imaging device. In various embodiments, the visualization device comprises a charge-coupled device (CCD) camera device, chip-on-stick CMOS imaging device, LED imaging, or ultrasound imaging device.  FIGS. 2A and 2B  further illustrate an embodiment of the flexible diaphragm  124  through which the endobronchial blocker  120  can be placed. The depicted compression cap  122  includes a compression channel formed between two compression members  126  into which the endobronchial blocker elastomeric sheath  125  is “snapped” or otherwise secured. In some embodiments, the compression members  126  provide compression of the sheath  125  against the visualization device (e.g., scope) within the sheath  125  and accomplish at least two functions. First, the compression members  126  can prevent migration of the distal end of the endobronchial blocker  120 , which includes a lumen-occluding balloon (as shown in  FIGS. 4A and 4B ). Second, the compression members  126  can provide compression on the visualization device itself to prevent rotation of a camera or other imaging device at a distal end of the visualization device, which could result in undesirable rotation of the visual image as it is being monitored or acquired. In various embodiments, the sheath  125  can comprise extruded silicone, urethane, TPE, latex, and/or other elastomeric or polymeric materials. 
         [0034]      FIG. 2C  illustrates a side view of an alternative compression cap or mechanism  122  (e.g., a “hair clip” embodiment). As shown, the compression cap  122  of  FIG. 2C  includes two “wings”  127  that when compressed toward each other open up the channel between the two compression members  126  such that the sheath  125  containing the visualization device (e.g., scope) can be laid or otherwise positioned within the compression channel without requiring significant pressure to “snap” it into place. In some embodiments, once the sheath  125  is positioned between the two compression members  126 , the compressed “wings”  127  are released, thereby causing the compression members  126  to once again return to their resting position and apply compression to the sheath  125  surrounding the visualization device. The sheath  125  may be captured either by the natural recoil of the design or, alternatively, by a spring mechanism, which can be placed between the wings  127  so that when the wings  127  are released, the compression members  126  actively capture the sheath and visualization device assembly  123  (e.g., similar to a hair clip with opposing jaws or claws operated by a spring mechanism). 
         [0035]      FIG. 3  schematically depicts an embodiment of a visualization device retention assembly  130 . The retention assembly  130  can include, for example, any of the features described in connection with the scope retention assemblies  123 ,  2725 ,  2825  described in WIPO Publ. No. WO 2013/063520, the entire content of which is incorporated herein by reference. The retention assembly  130  can be used in conjunction with one or more of the endotracheal tube cleaning devices, visualization devices, and/or airway cleaning devices described in WIPO Publ. No. WO 2013/063520, the entire content of which is incorporated herein by reference. In one embodiment, the retention assembly  130  includes an elastomeric sleeve  155 , a retention member  135  and a compression member  157 , which may operate and provide functions similar to the compression mechanism  122  identified and described in  FIGS. 2A-2C  above. A reverse bias or force can be exerted on a visualization device (e.g., visualization scope) by the retention member  135  (e.g., as a result of the stretchable elastomeric sleeve  155  wanting to return to its relaxed, non-stretched state) to advantageously press a distal visualization end of the visualization device against a window  141  at a distal end of the endobronchial blocker  120  (as shown in  FIGS. 4A and 4B ). In some embodiments, the visualization device comprises an engagement member that is configured to engage with the retention member  135  and is positioned at a location configured to allow the distal end of the visualization device to be held against, or in close proximity to, the window  141 . In various embodiments, the retention assembly  130  can be reused several times (e.g., 100-1000) times while still maintaining its effectiveness. The materials for the sleeve  155  can include extruded silicone, urethane, TPE, latex, and/or other elastomeric or polymeric materials. In some embodiments, the maximum elongation of the sleeve  155  can range from approximately 150% to 750% (e.g., from about 250% to 500%, from about 150% to 600%, from about 300% to 550%, from about 350% to 600%, from about 400% to 450%, overlapping ranges thereof, or 425%) 
         [0036]    Once a visualization device (e.g., scope) has been used to appropriately direct and place the endobronchial blocker  120  at a location within a tracheobronchial location (e.g., within a bronchus of a lung) or other anatomical location, the visualization device is uncoupled from the retention member  135  and pulled backward until appropriate visual identification and confirmation of balloon position of an occluding balloon of the endobronchial blocker (e.g., balloon  142  shown in  FIGS. 4A and 4B ) and tracheobronchial anatomy is obtained. At that point, the visualization device may then be “snapped” into position or otherwise coupled or positioned relative to the compression cap or mechanism  122  of  FIGS. 2A and 2B  or  FIG. 2C . Other designs and approaches of creating a static reverse force on the visualization device to improve the quality of visualization are possible without departing from the spirit and/or scope of the disclosure herein. 
         [0037]      FIGS. 4A and 4B  schematically illustrate a distal end of the endobronchial blocker  120 .  FIG. 4A  shows a distal end of a visualization scope  140  pressed up against a terminal optical window  141  of the catheter portion  121  of the blocker  120  and demonstrates the camera having at least a 90° angle of view, represented by angle a. A reverse bias or force can be exerted on the visualization scope  140  by the retention member  135  to advantageously press a viewing end  147  (e.g., lens end) of the visualization scope  140  against the window  141  at the distal end of the catheter portion  121  of the endobronchial blocker  120 . In some embodiments, such a configuration results in minimal or no air gap between the viewing end of the visualization scope  140  and the window  141 . In some embodiments, the window thickness combined with the lens indentation is less than about 0.010 inches (e.g., 0.001 inches, 0.002 inches, 0.003 inches, 0.004 inches, 0.005 inches, 0.006 inches, 0.007 inches, 0.008 inches, 0.009 inches, 0.010 inches, 0.001 inches to 0.010 inches, 0.005 inches to 0.010 inches, 0.009 inches to 0.010 inches, 0.006 inches to 0.009 inches, 0.075 inches to 0.010 inches, or overlapping ranges thereof) in order to reduce glare and/or halo effects and otherwise improve the quality of visualization. This can be particularly helpful during a treatment procedure because glare may make it difficult to view one or more anatomical features. However, in other embodiments, the clearance between a distal lens end of the visualization scope  140  and the window  141  of the endobronchial blocker  120  and/or the combined thickness of the window  141  and lens indentation can be different than disclosed herein. One or more antireflective coatings, layers or other features can be applied to the outside of the window  141  to further reduce glare. One or more elements to reduce condensation (e.g., anti-fogging) are provided in several embodiments. For example, a heating element can be thermally coupled to the window  141 . The heating element can heat up periodically, or as needed (e.g., as determined by a sensor), thereby warming the window  141  and preventing condensation or fog from forming on the window. In some embodiments, suction can be applied to the window  141  even in the absence of view-obstructing fluids because the application of suction would tend to cool the window  141  or remove vapor that might otherwise tend to condense on the window  141 . 
         [0038]    The window  141  can have a thickness of less than about 0.012 inches (for example, 0.001 inches, 0.002 inches, 0.003 inches, 0.004 inches, 0.005 inches, 0.006 inches, 0.007 inches, 0.008 inches, 0.009 inches, 0.010 inches, 0.011 inches, 0.012 inches, etc.). In one embodiment, the thickness of the window is about 0.005 inches. In some embodiments, the thickness of the window does not exceed about 0.008 inches. The window injection mold can be highly polished (e.g., with an SPE #1 finish and/or optical finish) or otherwise treated in order to ensure optical clarity of the molded parts. In some embodiments, the lens  147  of the visualization scope  140  is indented by a few thousandths of an inch (e.g., about 0.001 to about 0.004 inches) in order to prevent or reduce the likelihood of scratches and damage to the lens. 
         [0039]    In  FIG. 4A , the endobronchial occluding balloon  142  is collapsed or deflated. The catheter portion  121  of the endobronchial blocker  120  includes a pilot balloon channel  143  and an additional channel  144  configured to allow some degree of continuous positive airway pressure (CPAP), aspiration, irrigation, and/or insufflation of the airway beyond the occluding balloon  142  (e.g., via opening  146 ). In one embodiment, the additional channel  144  comprises a ventilation channel. 
         [0040]      FIG. 4B  schematically illustrates an embodiment of an occluding balloon  142  inflated and deployed within an appropriate bronchus with the distal end of the visualization scope  140  pulled back to a point such that the angle of view a shows the inflated balloon  142  and the surrounding tracheobronchial tree anatomy. In some embodiments, the view of the tracheobronchial tree anatomy is facilitated by optically clear components of the endobronchial blocker sheath  125  at this level. In some embodiments, the angle of view a can be greater than 90° (e.g., 90°-100°, 95°-110°, 90°-120°, 100°-120°, or overlapping ranges thereof) or less than 90° (e.g., 80°-90°, 70°-85°, 60°-75°, or overlapping ranges thereof). 
         [0041]      FIG. 5  depicts a proximal portion of the endobronchial blocker  120 . As shown, the endobronchial blocker  120  includes a balloon inflation control member  162 . The inflation control member  162  can include a one-way valve and release for selective inflation and deflation of the occluding balloon  142  via the pilot balloon channel  143 . Other seal members and/or or flow control mechanisms may also be used.  FIG. 5  also shows one embodiment of a ventilator connection member  164  configured for insufflation, aspiration, and/or or maintenance of some degree of CPAP with the balloon  142  deployed. In one embodiment, the ventilator connection member  164  is in communication with the additional channel  144 .  FIG. 5  further illustrates a distal end of the elastomeric sleeve  155  that provides at least a slight distal pressure of the visualization device distal tip (e.g., lens end of visualization scope) against the optical window  141  when used with the previously-described retention assembly  130 . As previously described, the elastomeric sleeve  155 , when compressed at some point along its length, can help prevent or reduce the likelihood of unwanted rotation of the visualization scope  140  within the endobronchial blocker sheath  125 . Although the exits of the pilot balloon inflation control member  162  and the ventilator connection member  164  tubing from the catheter portion  121  are shown originating distal to the connection of the elastomeric sleeve  155  with the distal endobronchial blocker sheath  125 , the exit point for these two structures can be located proximal to the connection of the elastomeric sleeve  155 , as desired or required for a particular application or use. 
         [0042]      FIG. 6  illustrates an exploded assembly view of one embodiment of the ventilation port of the tri-port connector  100 . In the illustrated embodiment, the oxygen connection adapter  101  is a standard “Christmas tree”-style or similar connector for connection of oxygen tubing that is configured to flush the endotracheal tube to pool oxygen (e.g., 100% oxygen) in the posterior oropharynx of the patient during intubation, as well as to prevent splash back of either secretions or blood onto the optical window  141  of the blocker  120  during the intubation procedure.  FIG. 6  further illustrates the ventilator connection site  104  that is provided when the oxygen connection adapter  101  (e.g., “Christmas tree” connector) is removed and secured by the tether  103 . 
         [0043]      FIG. 7  illustrates one embodiment of a configuration of caps or other seal members that can be used to cover the main manifold port  106  of the tri-port connector  100 . As shown, the cap  107  can be a tethered solid cap that can close off the main manifold port  106  completely. In the illustrated embodiment, the cap  107  includes a second tethered cap member  181  with a central distensible diaphragm  182 . In various embodiments, the diaphragm  182  can be configured to accommodate instruments such as a suction catheter or fiber-optic bronchoscope (e.g., instruments generally between 4 and 7 mm in diameter), and can seal around such instruments so that no leaks occur from the ventilatory circuit.  FIG. 7A  illustrates a close-up view of a section of a tether of the cap  107  that includes two bumps, protrusions or “knobs”  185  that are sized to clamp onto a sleeve or sheath of a visualization device once it has been positioned for intubation with a camera at the distal end of the endotracheal tube. Clamping of the sleeve or sheath with these knobs  185  may advantageously prevent or reduce the likelihood of axial or radial movement of the camera within the endotracheal tube during the intubation procedure, similar to the compression cap  122  described herein. The main manifold port  106  can include a “bump” or protrusion  186  configured to prevent the tether from moving in an unwanted fashion towards the cap  107  once the knobs  185  have been clamped onto the visualization device sheath. 
         [0044]      FIG. 8  illustrates one embodiment of a configuration of a cap assembly that can be used for a stylet and blocker port (e.g., manifold port  108 ) of the tri-port connector  100 . In the illustrated embodiment, the cap assembly includes a tethered solid cap  190  that can close off the stylet and blocker port  108  completely and a tethered cap  191  with a central distensible diaphragm  192  that can accommodate, for example, either an intubating stylet or the endobronchial blocker  120 , or other device having an outer diameter of between about 1.5 mm and 5 mm.  FIG. 8A  illustrates a close-up view of a section of a tether of the cap  190  that contains two bumps, protrusions, “knobs,” or other features  195  that are sized to clamp onto the endobronchial blocker  120  or other device once it has been appropriately positioned and the balloon  142  inflated within an appropriate bronchus of the lungs. In accordance with some embodiments, this clamping may advantageously help prevent, or reduce the likelihood of, migration of the blocker  120  during the procedure. The knobs  195  may provide functions similar to the compression cap  122  described herein. The manifold port  108  can include a “bump” or protrusion  196  that is configured to prevent the tether from interfering with functioning of the cap  191 . 
         [0045]      FIGS. 9A and 9B  illustrate an embodiment of the entire endobronchial blocker  120  in two different states of use.  FIG. 9A  illustrates a state of use with the visualization scope  140  inserted within the main lumen of the endobronchial blocker  120  and engaged with the scope retention assembly  130 . As described above, the scope retention assembly  130  may include a retention member  138  that is configured to engage with a corresponding retention member  148  on the visualization scope  140 . As shown in  FIG. 9A , with the retention member  138  engaged with the retention member  148 , the distal end of the visualization scope  140  is pressed against the window  141  at the distal end of the endobronchial blocker  120 . 
         [0046]      FIG. 9B  illustrates a state of use wherein the balloon  142  is inflated and the visualization scope  140  has been disengaged from the retention member  138  and withdrawn to a position proximal to the balloon  142  to facilitate visualization of the inflated balloon  142  through the transparent or optically clear wall of the catheter portion  121  of the endobronchial blocker  120 , as described in more detail above. In some embodiments, the entire catheter portion  121  of the endobronchial blocker  120  is transparent or optically clear other than the elastomeric sleeve  155 . In some embodiments, at least a portion of the catheter portion  121  proximal to the balloon  142  is transparent or optically clear sufficient to facilitate visualization of the balloon  142 . 
         [0047]    In accordance with several embodiments, the endobronchial blocker  120  can be inserted within the tri-port connector  100  after performing a routine intubation. In accordance with several embodiments, the intubation may be facilitated through the use of a visualization or imaging system, such as one or more of the visualization systems described in WIPO Publication Number WO 2013/063520, the entire content of which is incorporated herein by reference, which may be used to confirm proper positioning of placement of a distal end of an endotracheal tube during intubation of a patient using direct visualization. In some embodiments, a patient is anesthetized and intubated with a single-lumen endotracheal tube or other body-inserted medical tube according to clinician preference, and the endotracheal tube is secured to the patient. In various embodiments, the lumen of the endotracheal tube is from 5 mm to 9 mm. 
         [0048]    In some embodiments, the tri-port connector  100  is inserted between the endotracheal tube and a ventilator, with the ventilator connected to a ventilator port of the tri-port connector  100  and the endotracheal tube connected to the universal connection port  111 . In some embodiments, the endobronchial blocker  120  is inserted through the stylet port (e.g., manifold port  108 ) of the tri-port connector  100  and advanced distally through the endotracheal tube. In some embodiments, with the assistance of visualization provided by the camera at the tip of the endobronchial blocker  120  behind an optically clear window  141 , the images of which are displayed on a monitor, the distal end of the endobronchial blocker  120  is directed into the chosen bronchus for occlusion. The monitor or a storage device coupled to the monitor can store video or still images obtained and/or transmit the images to a remote location. Steering may be provided by slight angulation near the tip of the endobronchial blocker  120 . Visualization on the compatible monitor can also allow for confirmation of placement of the distal tip of the endotracheal tube. 
         [0049]    In some embodiments, a camera or other imaging device at the distal end of the visualization scope  140  may then be withdrawn proximally to the origin of the balloon  142  and the balloon  142  may be inflated under direct vision to be certain that it inflates appropriately and in the correct position. Tracheobronchial landmarks, such as the carina and non-occluded bronchus or bronchi, can be easily viewed through a transparent or substantially transparent catheter portion  121  proximal to the origin of the occluding balloon  142 . 
         [0050]    Continuously or intermittently (e.g., at certain times during the procedure), the position of the balloon  142  can be easily confirmed and adjusted as desired or necessary, as the visualization scope  140  remains in place in the catheter portion  121  of the endobronchial blocker  120  throughout the duration of the operative procedure. In some embodiments, once the procedure or treatment has been completed, the balloon  142  is deflated and the endobronchial blocker  120  is removed. 
         [0051]    The materials used for the various components of the connectors and endobronchial blockers described herein can advantageously comprise one or more biocompatible materials. Such materials can be rigid or semi-rigid and/or flexible, as desired or required for a particular application or use. The materials used can include, but are not limited to, polyether ether ketone (PEEK), Nylon 6/6, polyethylene, polypropylene, polyethylene terephthalate (PET), glycol-modified PET, polyvinyl chloride (PVC), thermoplastic elastomers (TPEs) such as PEBAX TPEs, other natural or synthetic polymers (e.g., KRATON polymers), silicone, natural rubber, latex, polycarbonate, K resin, acrylonitrile butadiene styrene (ABS), styrenes and/or other thermoplastic elastomers or polymers. The caps disclosed herein may be tethered or non-tethered. In various embodiments, the removable caps may be configured to be coupled via threaded coupling, snap-fit coupling, friction-fit coupling and/or any other type of connection device or method. The diaphragms or other seal member may be configured to seal or otherwise close down around and conform to an outer diameter of the devices inserted therethrough. 
         [0052]    While the invention is susceptible to various modifications, and alternative forms, specific examples thereof have been shown in the drawings and are herein described in detail. It should be understood, however, that the invention is not to be limited to the particular forms or methods disclosed, but to the contrary, the invention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the various embodiments described and the appended claims. Any methods disclosed herein need not be performed in the order recited. The methods disclosed herein include certain actions taken by a practitioner; however, they can also include any third-party instruction of those actions, either expressly or by implication. For example, actions such as “inflating a balloon” include “instructing the inflating of a balloon.” 
         [0053]    Various embodiments of the invention have been presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. The ranges disclosed herein encompass any and all overlap, sub-ranges, and combinations thereof, as well as individual numerical values within that range. For example, description of a range such as from 70 to 115 degrees should be considered to have specifically disclosed subranges such as from 70 to 80 degrees, from 70 to 100 degrees, from 70 to 110 degrees, from 80 to 100 degrees etc., as well as individual numbers within that range, for example, 70, 80, 90, 95, 100, 70.5, 90.5 and any whole and partial increments therebetween. Language such as “up to,” “at least,” “greater than,” “less than,” “between,” and the like includes the number recited. Numbers preceded by a term such as “about” or “approximately” include the recited numbers. For example, “about 10%” includes “10%.” For example, the terms “approximately”, “about”, and “substantially” as used herein represent an amount close to the stated amount that still performs a desired function or achieves a desired result.