Abstract:
A surgical system includes an extended working channel, a magnetic field generator, a sensor, a workstation, a computer readable recording medium, and a remote control handle. The extended working channel is sized for insertion into the working channel of a bronchoscope and to receive one or more instruments therethrough. The sensor is associated with a distal end of the extended working channel for detecting a magnetic field generated by the magnetic field generator. The workstation includes a display and is operably connected to the sensor. The computer readable recording medium is associated with the workstation for storing a software program that enables association of the sensed magnetic field with a location of the sensor and that generates one or more images including one or more fields for presentation on the display. The remote control handle enables manipulation of the one or more fields generated by the software.

Description:
BACKGROUND 
       [0001]    1. Technical Field 
         [0002]    The present disclosure relates to surgical instruments and, more specifically, to remote controls for bronchoscopy navigation systems. 
         [0003]    2. Discussion of Related Art 
         [0004]    A common interventional procedure in the field of pulmonary medicine is bronchoscopy, in which a bronchoscope is inserted into the airways through the patient&#39;s nose or mouth. The structure of a bronchoscope generally includes a long, thin, flexible tube that typically contains three elements: an illumination assembly for illuminating the region distal to the bronchoscope&#39;s tip via an optical fiber connected to an external light source; an imaging assembly for delivering back a video image from the bronchoscope&#39;s distal tip; and a lumen or working channel through which instruments may be inserted, including but not limited to placement (e.g., guide wires), diagnostic (e.g., biopsy tools) and therapeutic (e.g., treatment catheters or laser, cryogenic, radio frequency, or microwave tissue treatment probes) instruments. The distal tip of a bronchoscope is steerable. Rotating a lever placed at the handle of the bronchoscope actuates a steering mechanism that deflects the tip in one or more directions. 
         [0005]    Bronchoscopies are performed by pulmonologists, also known as bronchoscopists, and are used routinely in the diagnosis and treatment of conditions such as lung cancer, airway stenosis, and emphysema. Bronchoscopies are typically performed by a staff of at least two persons: the bronchoscopist and at least one assistant, usually a nurse. During a typical procedure, the bronchoscopist holds the bronchoscope handle with one hand and the bronchoscope tube with the other hand. The bronchoscopist guides the distal tip of the bronchoscope and/or other instruments by manipulating a proximal end of the bronchoscope tube or the other instruments. 
         [0006]    During insertion and operation of the instruments, images from the bronchoscope and/or other instruments may be viewed by the bronchoscopist on display devices. The settings of the display devices and/or the images on the display devices may be manipulated by user interfaces of the display devices. To operate the user interfaces the clinician must remove one hand from the bronchoscope or have an assistant manipulate the user interface. However, the bronchoscope needs to be held steady during insertion and manipulation. Two hands are typically needed to hold the bronchoscope steady. 
         [0007]    These difficulties are exacerbated when tools are passed through the working channel of the bronchoscope. For example, when inserting biopsy tools or using the navigation systems such as the EDGE™ and SUPERDIMENSION™ navigation catheters currently sold by Covidien LP. Indeed these additional tools require one hand just for their manipulation. Accordingly, manipulation of a bronchoscope and such an additional tool requires a second person, particularly to simultaneously manipulate the user interface. 
         [0008]    Performing a procedure that requires two people is generally more expensive and the potential for error is increased. Hence, it is desirable to modify a procedure so that it may be performed with one or two hands, if possible. 
       SUMMARY 
       [0009]    In an aspect of the present disclosure, a surgical system includes an extended working channel, a magnetic field generator, a sensor, a workstation, a computer readable recording medium, and a remote control handle. The extended working channel is sized for insertion into the working channel of a bronchoscope and to receive one or more instruments therethrough. The sensor is associated with a distal end of the extended working channel for detecting a magnetic field generated by the magnetic field generator. The workstation includes a display and is operably connected to the sensor. The computer readable recording medium is associated with the workstation for storing a software program that enables association of the sensed magnetic field with a location of the sensor and that generates one or more images including one or more fields for presentation on the display. The remote control handle enables manipulation of the one or more fields generated by the software and presented on the display. The one or more instruments may include a locatable guide that houses the sensor. 
         [0010]    In aspects, the remote control handle includes a plurality of direction buttons to navigate between the one or more fields presented on the display by the software. The remote control handle may include a selection control button enabling selection of one or more options presented in the one or more fields on the display by the software. 
         [0011]    In some aspects, the remote control handle includes a joystick to navigate between the one or more fields presented on the display by the software. The joystick may be vertically depressible to enable selection of one or more options presented in the one or more fields on the display by the software. The system may include a hand selection switch enabling left or right handed operation orienting movements of the software with the selection. The hand selection switch may be disposed on the remote control handle. 
         [0012]    In certain aspects, the remote control handle includes a trackball to navigate between the one or more fields presented on the display by the software. The trackball may be vertically depressible to enable selection of one or more options presented in the one or more fields on the display by the software. The remote control handle may include indicia of location on the trackball. 
         [0013]    In particular aspects, the remote control handle is in communication with the workstation. The communication may be wireless communication. 
         [0014]    In certain aspects, the remote control handle is formed at a proximal end of a locatable guide housing the sensor which is insertable into the extended working channel. The proximal portion of the extended working channel may include a handle for receiving the remote control handle. The remote control handle and the handle of the extended working channel can be secured together to fix the relationship of the extended working channel to the locatable guide. A portion of the handle of the extended working channel is telescopic to enable the fixed locatable guide and the extended working channel to be advanced in unison. 
         [0015]    In aspects, the images are images of lungs of a patient. The software may display a 3D model generated from the one or more images. The software may generate a pathway to a target and the location of the sensor on that pathway on the one or more images or 3D model for presentation on the display. The software may enable the presentation of video images from a bronchoscope. 
         [0016]    Further, to the extent consistent, any of the aspects described herein may be used in conjunction with any or all of the other aspects described herein. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0017]    Various aspects of the present disclosure are described hereinbelow with reference to the drawings, which are incorporated in and constitute a part of this specification, wherein: 
           [0018]      FIG. 1  is a perspective view of an illustrative embodiment of an electromagnetic navigation system in accordance with the present disclosure; 
           [0019]      FIG. 2  is an illustration of a user interface of the workstation of  FIG. 1  presenting a view for performing registration in accordance with the present disclosure; 
           [0020]      FIG. 3  is an enlarged view of the indicated area of detail of  FIG. 1 ; 
           [0021]      FIG. 4  is another embodiment of a handle remote in accordance with the present disclosure; and 
           [0022]      FIG. 5  is yet another embodiment of a handle remote in accordance with the present disclosure. 
       
    
    
     DETAILED DESCRIPTION 
       [0023]    Devices, systems, and methods for navigating to a target within a luminal network, for example, a patient&#39;s lungs, are provided in accordance with the present disclosure and described in detail below. The disclosed devices, systems, and methods provide a clinician with easy to use workflow systems guiding the clinician through the various steps involved in performing navigation to a target in the luminal network and improved means of manipulating the workflow or user interface. 
         [0024]    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 variously employ the present disclosure in virtually any appropriately detailed structure. While the following embodiments are described in terms of luminal navigation 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. 
         [0025]    With reference to  FIG. 1 , an electromagnetic navigation (EMN) system  10  is provided in accordance with the present disclosure. One such EMN system is the ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY® system currently sold by Covidien LP. Among other tasks that may be performed using the EMN system  10  are planning a pathway to target tissue, navigating a catheter guide assembly to the target tissue, deploying a biopsy tool through the catheter assembly into the target tissue to obtain a tissue sample from the target tissue using the biopsy tool, digitally marking the location where the tissue sample was obtained in a data file related to the planned pathway, and placing one or more echogenic markers at or around the target. 
         [0026]    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; a tracking system  70  including a tracking module  72 , a plurality of reference sensors  74 , and an electromagnetic field generator  76 ; a workstation  80  including software and/or hardware used to facilitate pathway planning, identification of target tissue, navigation to target tissue, and digitally marking the biopsy location 
         [0027]      FIG. 1  also depicts a catheter guide assembly  100  usable with the EMN system  10 . The catheter guide assembly  100  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 a bronchoscope  50 . 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  93  of the EWC  96 . As shown in  FIG. 2 , the LG  92  is not quite to the desired location extending beyond the distal end of 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 . The catheter guide assembly  100  has a handle  91  that can be manipulated by rotation and compression to steer the distal tip  93  of the LG  92  and the extended working channel  96 . An example of a suitable catheter guide assembly is currently marketed and sold by Covidien LP under the name EDGE™ Procedure Kits. For a more detailed description of the catheter guide assembly  100  reference is made to commonly-owned U.S. Provisional Patent Application Ser. No. 62/020,240 filed on Jul. 2, 2014 and entitled System and Method for Navigating within the Lung, the entire contents of which are hereby incorporated by reference. 
         [0028]    As illustrated in  FIG. 1 , the patient is shown lying on operating table  40  with bronchoscope  50  inserted through the patient&#39;s mouth and into the patient&#39;s airways. Bronchoscope  50  includes a source of illumination and a video imaging system (not explicitly shown) and is coupled to monitoring equipment, e.g., a display  81 , for displaying the video images received from the video imaging system of bronchoscope  50 . As shown, the display  81  is integrated with and is also the display for workstation  80 ; however, it is contemplated that the display could also be a separate monitor (not shown). 
         [0029]    The catheter guide assembly  100  including LG  92  and EWC  96  are configured for insertion through a port  84  formed at the proximal end of bronchoscope  50  into the patient&#39;s airways (although the catheter guide assembly  100  may alternatively be used without bronchoscope  50 ). The LG  92  and EWC  96  are selectively lockable relative to one another via a locking mechanism (not shown). A six degrees-of-freedom electromagnetic tracking system  70 , e.g., similar to those disclosed in U.S. Pat. No. 6,188,355 entitled Wireless Six-degree-of-freedom Locator, and published PCT Application No. WO 01/67035 entitled Object Tracking using a Single Sensor or a Pair of Sensors, the entire contents of each of which are incorporated herein by reference, or any other suitable positioning measuring system, is utilized for performing navigation, although other configurations are also contemplated. Tracking system  70  is configured for use with catheter guide assembly  100  to track the position of the EM sensor  94  as it moves in conjunction with the LG  92  and EWC  96  through the airways of the patient, as detailed below. 
         [0030]    During procedure planning, workstation  80  utilizes computed tomographic (CT) image data for generating and viewing a three-dimensional model (“3D model”) of the patient&#39;s airways, enables the identification of target tissue on the 3D model (automatically, semi-automatically or manually), and allows for the selection of a pathway through the patient&#39;s airways to the target tissue. 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. The 3D model may be presented on a display  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 a target and selection of a suitable pathway through the patient&#39;s airways to access the target. 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 to which a pathway can be planned. Once selected, the pathway is saved for use during the navigation procedure. An example of a suitable pathway planning system and method is described in U.S. patent application Ser. No. 13/838,805 entitled Pathway Planning System and Method, filed on Mar. 15, 2014, the entire contents of each of which are incorporated herein by reference. 
         [0031]    During navigation, EM sensor  94 , in conjunction with tracking system  70 , enables tracking of EM sensor  94  as EM sensor  94  is advanced through the patient&#39;s airways. As shown in  FIG. 2 , view  400  of monitor  81  presents a clinician with a video feed  402  from bronchoscope  50  and a lung survey  404  from the planning phase. The lung survey view  400  is one of a variety of screens available to a user when utilizing an EMN navigation software such as that described U.S. Provisional Patent Application Ser. No. 62/020,240, incorporated herein above. Video feed  402  from bronchoscope  50  provides the clinician with a real-time video of the interior of the patient&#39;s airways at the distal end of bronchoscope  50 . Video feed  402  allows the clinician to visually navigate the bronchoscope  50  through the airways of the lungs of the patient. The clinician advances the bronchoscope  50  with the EWC  96  and the LG  92  extending therefrom through the airways of the lungs until the real-time position of the airways of the lungs of the patient are registered with the pathway planned during the planning phase. More details regarding the process of registration are set forth in U.S. Patent Application No. 62/020,220 filed Jul. 2, 2014 and entitled REAL-TIME AUTOMATIC REGISTRATION FEEDBACK, the entire contents of which are incorporated herein by reference. 
         [0032]      FIG. 2  provides a specific example of one view in a pathway navigation and procedure software. In this view as well as many others provided in such a software package, before and during the registration process as well as during the navigation and treatment phases of such systems, the clinician may be required to select tabs on the monitor  81  to select a target, change tabs, select a navigation plan, activate a navigation plan, manipulate an image (e.g., zoom in and out, or rotate), or provide indicia to the workstation  80  (e.g., “click” a dialog box or choose an option). As described above, removal of a clinician&#39;s hands from the bronchoscope  50  or the catheter guide assembly  100  is required for operation of such software and making selections, for example on a display  81  or necessitates the use of another clinician to fully operate the system. 
         [0033]    Referring to  FIGS. 1 and 3 , the EMN system  10  includes a handle remote  102  that may form the proximal end of the LG  92 , and is releasably coupled to a handle  91  which forms the proximal end of the EWC  96 . The handle  91  is connected at its distal end to port  84  to the working channel of the bronchoscope  50 . The handle  91  includes a telescopic portion  86 , enabling the LG  92  and EWC  96  to move together through the working channel of bronchoscope  50 . The handle remote  102  is in communication with the workstation  80  to allow a clinician to interface with the workstation  80  without releasing the handle remote  102  or the bronchoscope  50 . The handle remote  102  may be wired to the workstation  80  or be in wireless communication with the workstation  80 . The wireless connection may be via radio frequency, optical, WIFI, Bluetooth® (an open wireless protocol for exchanging data over short distances (using short length radio waves) from fixed and mobile devices, creating personal area networks (PANs)), ZigBee® (a specification for a suite of high level communication protocols using small, low-power digital radios based on the IEEE 802.15.4-2003 standard for wireless personal area networks (WPANs)), etc. 
         [0034]    The handle remote  100  includes a proximal end  101  and a distal end  104  having a securement device  106 . The distal end  104  of the handle remote  100  is sized and dimensioned to be received within and releasably couple to the proximal end of the handle  91 . The securement device  106  may be a clip that is received within a slot  97  defined in handle  91  which rotationally fix the securement device  106  to the handle  91 . Alternatively, the securement device  106  may releasably couple the handle remote  100  to the handle  91  while allowing the handle remote  100  to rotate relative to the handle  91 . 
         [0035]    With particular reference to  FIG. 3 , the handle remote  100  includes a remote interface  110  having directional controls  112   a - d  and a selection control  114 . The direction controls  112   a - 112   d  allow a clinician to move a cursor on the display  81  of the workstation  80  in a manner similar to an input device such as a computer mouse (e.g., to move objects selected about the monitor  81 , to select dialog boxes or buttons on monitor  81 ). Each of the directional controls  112   a - d  are orientated to the display  81  of the workstation  80  (i.e., directional control  112   a  is up on the display  81 , direction control  112   b  is right on the display  81 , etc.). The selection control  114  allows a clinician to choose options on the monitor  81  (e.g., activate a dialog box, select a plan, or mark a point on the display  81 ). The selection control  114  may perform operations on the display  81  similar to operations performed by a left mouse click. It is contemplated that the remote interface  110  may include an option control (not shown) that performs operations on the display  81  similar to operations performed by a right mouse click. 
         [0036]    The remote interface  110  may be sized and configured to be gripped by the hand of a clinician during manipulation of the handle  102 . The handle remote  102  may include a distal ring  108  proximal to the securement device  106  to that may prevent accidental disengagement of a hand of a clinician from the handle remote  102  (e.g., the hand of a clinician sliding off of the handle remote  102 ). In addition, the distal ring  108  provides tactile indicia to a clinician to the position of the distal end  104  of the handle remote  102  to permit the clinician to position the handle remote within a hand. 
         [0037]    With reference to  FIG. 4 , another handle remote  120  includes proximal end  122  and a distal end  124 . Similar to the distal end  104  of the handle remote  100 , the distal end  124  of the handle remote  120  includes a securement device  106  for securing the handle remote  120  to the handle  91 . The handle remote  120  includes a body  129  and a user interface  130 . The body  129  is sized and configured to be gripped by the hand of a clinician during manipulation of the handle  91 . The body  129  includes a distal ring  108 . 
         [0038]    The remote interface  130  is disposed on the proximal end  122  of the handle remote  120  and includes a directional control  132  that allows a clinician to move a cursor on the display  81  of the workstation  80  in a similar manner to the direction controls  112   a - d  of the remote interface  110  detailed above. The direction control  132  is joystick that is configured to be engaged by a thumb of a clinician. The direction control  132  may be moveable in any direction or may be limited to movement in just the X and Y axis ( FIG. 4 ). The directional control  132  may include indicia  136  to a clinician to facilitate orientation of the X axis of the directional control  132  with right and left movement of the cursor on the display  81  and to orient the Y axis of the directional control  132  with up and down movement on the display  81 . The indicia  136  may provide a tactile surface such that a clinician may orientate the direction control  132  without diverting attention away from the surgical procedure. The direction control  132  may be depressible to choose options on the display  81  similar to the selection control  114  of the remote interface  110  detailed above. The direction control  132  may provide tactile and/or haptic feedback to the clinician when the direction control  132  is depressed. 
         [0039]    In embodiments, the body  129  may orientate the handle remote  120  in a hand of a clinician such that the X and Y axis of the direction control  132  are orientated with movement of a thumb of the hand of the clinician (e.g., when the hand grips the body  129  of the handle remote  120 , movement of the direction control  132  to the right moves the cursor to the right). It will be appreciated that in such embodiments, the handle remote  120  may be right handed or left handed. In some embodiments, the remote interface  130  may include an orientation switch  133  to choose between right and left handed operation of the remote handle  120 . 
         [0040]    With reference to  FIG. 5 , another handle remote  140  includes a proximal end  142  and a distal end  144 . Similar to the distal end  104  of the handle remote  100 , the distal end  144  of the handle remote  140  includes a securement device  106  for securing the handle remote  140  to the handle  91 . The handle remote  140  includes a body  149  and a remote interface  150 . The body  149  of the handle remote  140  is similar to the body  129  of the handle remote  120  detailed above. 
         [0041]    The remote interface  150  includes a direction control  152  in the form of a trackball. The direction control  152  is operable in a similar manner to the direction control  132  of remote interface  130 . The direction control  152  may be depressible to choose options on the display  81  similar to the direction control  132  detailed above. The remote interface  150  may include an indicia  156  to provide a tactile surface such that a clinician may orientate the direction control  152  without diverting attention away from a surgical procedure in a similar manner to indicia  136  detailed above. The indicia  156  may be disposed on the proximal end  142  of the handle remote  140 . 
         [0042]    While several types of remote interfaces (e.g. remote interfaces  110 ,  130 ,  150 ) are shown herein, it is contemplated that the remote interface may also be an optical sensor to detect movement of a finger of a clinician over the sensor, a track pad, or a touch screen. It is also contemplated that the remote interface may receive voice commands from a clinician to operate the workstation  80 . 
         [0043]    By providing a handle remote (e.g., handle remote  100 ,  120 ,  140 ) a clinician may manipulate the handle  91  to guide the LG  92  and EWC  96  to a target within a lung of a patient and operate the workstation  80  without releasing the handle  91  or the bronchoscope  50 . By allowing manipulation of the handle  91  and the workstation  80  with one hand of a clinician, the clinician can operate the workstation  80  and the handle  91  without drawing the clinician&#39;s attention away from the monitor  81  of the workstation  80 . In addition, the number of clinicians for a given procedure may be reduced, which in turn reduces the cost of the procedure. 
         [0044]    As used herein, the term “distal” refers to the portion that is being described which is further from a user, while the term “proximal” refers to the portion that is being described which is closer to a user. Further, to the extent consistent, any of the aspects and features detailed herein may be used in conjunction with any or all of the other aspects and features detailed herein. 
         [0045]    While several embodiments of the disclosure have been shown in the drawings, it is not intended that the disclosure be limited thereto, as it is intended that the disclosure be as broad in scope as the art will allow and that the specification be read likewise. Any combination of the above embodiments is also envisioned and is within the scope of the appended claims. Therefore, the above description should not be construed as limiting, but merely as exemplifications of particular embodiments. Those skilled in the art will envision other modifications within the scope of the claims appended hereto.