Sub-segment display of virtual target volume and sampling history

Abstract

A system and method for planning endoluminal navigation including receiving imaging of the luminal network, receiving an indication of an area of interest within the imaging, receiving an indication of a plurality of targets within the area of interest for sampling, generating and displaying a user interface a three-dimensional (3D) model of the luminal network, generating a navigational pathway through the luminal network to the area of interest on the user interface, and generating a plurality of launch points within the 3D model along the navigational pathway, each launch point defining a location and orientation of a catheter such that a biopsy tool extended from the catheter will impact at least one target in the area of interest associated with the launch point.

Description

SUB-SEGMENT DISPLAY OF VIRTUAL TARGET VOLUME AND SAMPLING HISTORYBACKGROUNDTechnical Field

[0001] This disclosure relates to the field of medical device navigation, and in particular, to systems for navigating a medical device to an area of interest and collecting a biopsy or applying a therapy at the area of interest.Description of Related Art

[0002] There are several commonly applied medical methods, such as bronchoscopic and endoscopic procedures or other minimally invasive procedures, for treating various maladies affecting organs including the liver, brain, heart, lungs, gall bladder, kidneys, and bones. Often, one or more imaging modalities, such as magnetic resonance imaging (MRI), ultrasound imaging, computed tomography (CT), or fluoroscopy are employed by clinicians to identify areas of interest within the organ imaged for biopsy and therapy. Along with identification of the areas of interest, these imaging modalities provide image data for the generation of three-dimensional (3D) models of the organ imaged and the luminal pathways within the organ. As an example, the ILLUMISITE™ system manufactured and sold by MEDTRONIC Pic utilizes CT images to generate 3D models of the lungs and the airways of the patient.

[0003] Along with generating the 3D model, software like ILLUMISITE™ generates navigational pathways through the airways of the lungs which can be followed by the pulmonologist or thoracic surgeon to place a catheter at or near the area of interest so that a biopsy can be collected, or a therapy can be applied to the area of interest. A locating or tracking system, such as an electromagnetic (EM) tracking system, may be utilized in conjunction with the 3D model so that navigation of the catheter is displayed in the 3D model. As will be appreciated, accurate placement of the catheter and therewith the medical instrument is important to ensure successful therapy. Improvements to the current navigation catheter systems are desired.SUMMARY

[0004] One aspect of the disclosure is directed to a system for endoluminal navigation. The system includes a catheter configured for navigation within a luminal network of a patient. Thesystem also includes a sensor associated with a distal portion of the catheter and outputting a signal; and a computing device including a memory, a processor, and a display, the memory storing instructions that when executed by the processor: receive imaging of the luminal network; receive an indication of an area of interest within the imaging; receive an indication of a plurality of targets within the area of interest for sampling; generate and display, on a user interface, a three- dimensional (3D) model of the luminal network; generate a navigational pathway through the luminal network to the area of interest; and generate a plurality of launch points along the navigational pathway, each launch point defining a location and orientation of the catheter such that a biopsy tool extended from the catheter will impact at least one target of the plurality of targets in the area of interest associated with the launch point. Other embodiments of this aspect include corresponding computer systems, apparatus, and computer programs recorded on one or more computer storage devices, each configured to perform the actions of the methods.

[0005] Implementations may include one or more of the following features. The system where the computing device stores instructions that when executed by the processor determines an order for each of the plurality of targets to be sampled. The computing device stores instructions that when executed by the processor receives via the user interface an indication of an identity of biopsy tool. The computing device stores instructions that when executed by the processor receive the signal from the sensor and presents, on the user interface, a location of a distal portion of the catheter on the 3D model of the luminal network. The computing device stores instructions that when executed by the processor generates a pathway from each of the plurality of launch points to at least one target of the plurality of targets. The pathway extends from one of the plurality of launch outside of the luminal network to reach the at least one target. The computing device stores instructions that when executed by the processor receives intraprocedural images and receives a confirmation that a biopsy tool is placed within at least one target of the plurality of targets. The computing device stores instructions thereon that when executed by the processor receives an indication that a biopsy sample has been collected and presents instructions for reorientation or advancement of the catheter to a second launch point. The catheter is robotically-driven catheter. The computing device stores instructions thereon that when executed by the processor identifies the area of interest in the imaging of the luminal network and presents a request for confirmation on the user interface. The computing device stores instructions thereon that when executed by the processor identifies at least one of the plurality of targets within the area of interest and presents arequest for confirmation on the user interface. Implementations of the described techniques may include hardware, a method or process, or computer software on a computer-accessible medium.

[0006] A further aspect of the disclosure is directed to a method of planning endoluminal navigation. The method includes receiving imaging of a luminal network; receiving an indication of an area of interest within the imaging; receiving an indication of a plurality of targets within the area of interest for sampling; generating and display, on a user interface, a three-dimensional (3D) model of the luminal network; generating a navigational pathway through the luminal network to the area of interest on the user interface; and generating a plurality of launch points within the 3D model along the navigational pathway, each launch point defining a location and orientation of a catheter such that a biopsy tool extended from the catheter will impact at least one target of the plurality of targets in the area of interest associated with the launch point. Other embodiments of this aspect include corresponding computer systems, apparatus, and computer programs recorded on one or more computer storage devices, each configured to perform the actions of the methods.

[0007] Implementations may include one or more of the following features. The method may include determining an order in which each of the plurality of targets will be sampled. The method may include receiving, via the user interface, an indication of an identity of a biopsy tool. The method may include receiving a signal from a sensor on the catheter and presenting in the user interface a location of a distal portion of the catheter in the 3D model. The method may include generating a pathway from each of the plurality of launch points to at least one target of the plurality of targets. The pathway extends from one of the plurality of launch points outside of the luminal network to reach the at least one target. The catheter is robotically driven catheter. An application stored in a memory on a computing device identifies the area of interest in the imaging of the luminal network and presents a request for confirmation on the user interface. An application stored in a memory on a computing device identifies at least one of the plurality of targets within the area of interest and presents a request for confirmation on the user interface. Implementations of the described techniques may include hardware, a method or process, or computer software on a computer-accessible medium.BRIEF DESCRIPTION OF THE DRAWINGS

[0008] Various aspects and embodiments of the disclosure are described hereinbelow with references to the drawings, wherein:

[0009] FIG. l is a schematic view of a navigation system in accordance with the disclosure;

[0010] FIG. 2 is a robotic or motor operated catheter system in accordance with the disclosure;

[0011] Fig. 3 is a user interface in accordance with the disclosure;

[0012] FIG s. 4A and 4B are a flow diagram of a method in accordance with the disclosure;

[0013] Fig. 5 is a schematic diagram of a navigational computer system in accordance with the disclosure; and.

[0014] Fig. 6 is a flow chart of a method for de-articulation and articulation to a desired location in accordance with the disclosureDETAILED DESCRIPTION

[0015] The disclosure is directed to systems and methods of improving the identification of areas of interest within organs to which catheters are to be navigated to improve the accuracy of sampling (e.g., biopsy) or treatment. In accordance with aspects of the disclosure, a user interface may be presented on a display. The user interface presents either actual image data (e.g., CT images), a 3D model, combinations of the two, and other images (e.g., maximum intensity projection images). The areas of interest may be identified in the images or 3D model (either manually or via image processing software). The area of interest may be subdivided into multiple targets. Certain of these targets can be selected (again either manually or via an application). These targets within the area of interest may be selected so that the area of interest can be thoroughly sampled. A pathway plan can then be developed for navigation of the catheter within luminal structures of the organs (e.g., airways within the lungs). The pathway plan may take into account an order in which each of the targets is to be sampled. As such each target will define a location at which the catheter is to be navigated to from which a biopsy tool can be extended from the catheter to reach the target. The pathway play may also define an order in which each of these locations are to be navigated to in order to efficiently perform the procedure. The locations and the order may take into account such factors as distance from the target, trajectory of the catheter at the location, distance of tissue through which the biopsy tool must travel to reach the target, proximity of other structures (e g., parenchyma, blood vessels, fissures, etc ).

[0016] The catheter may be manually or robotically navigated to each of the locations such that a biopsy can be collected from each target within the area of interest. As each location is reached and a biopsy sample is acquired the actual location at which the catheter is within thepatient may be recorded and stored in memory and in some instances presented on the user interface. In certain instances these locations may be returned to when either the biopsy sample collected is insufficient or though sufficient requires a further sample for additional testing. Still further, in some instances a clinical decision may be made during a procedure to apply therapy based on the results of the biopsy. In these instances, without removing the catheter from the patient the catheter may again be navigated to one or more of locations from which a biopsy was acquired and the therapy instrument may be inserted into the catheter and the therapy applied to the target to treat the area of interests or portions of the area of interest.

[0017] Along with storing the location of the catheter, applications may record the path taken by the catheter to reach the location. This tracking enables an assessment of a “straightness” of a distal portion of the catheter, an orientation of an opening in the distal portion of the catheter (e.g., in 6 degrees of freedom), and a potential trajectory the biopsy or therapy tool as it extends out of the catheter. The assessment may include a score that is presented on the user interface to provide an indication to the clinician of the likelihood of the biopsy to have been collected from the intended target at the desired location and instructions for adjusting the placement to improve the likelihood of reaching the desired location. These and other aspects of the disclosure are described in greater detail below.

[0018] Fig. 1 depicts a system 100 for navigation within a patient’s luminal network (e.g., a lung navigation system). As depicted in Fig. 1, the patient (P) is placed on a procedure table 102, with an electromagnetic (EM) antenna board 104 beneath the patient. The antenna board 104 generates an EM field around the patient, and particularly the chest of the patient in which the lungs are located. The antenna board 104 may include a plurality of markers or beads in a repeating or non-repeating pattern that can be identified in images (e.g., fluoroscopic, cone beam computed tomography (CBCT), ultrasound, etc.). The markers or beads assist in registration of images and 3D models to the patient and the EM field. EM sensors 106 are placed on the patient, for example, one near the xyphoid process in the center of the chest, and one each on the left and right sides of the patient. The EM sensors 106 can detect the EM field and can be used to assist in registration of the patient to pre-procedural or intraprocedural images and for collecting data regarding movement of the chest, which can be correlated to movements of the airways of the patient. A bronchoscope 108 is inserted into the patient’s mouth through the trachea and into the airways of the lungs. As will be appreciated the bronchoscope 108 includes a light emitting element and acamera allowing for visual navigation of the airways of the lungs. However, as will be appreciated a bronchoscope 108 cannot be navigated all the way to the periphery of the lungs where the airways are quite small.

[0019] A navigation catheter 110 can be inserted into a port on the bronchoscope 108 and extended through a working channel of the bronchoscope 108. The navigation catheter 110 may be for example the EDGE™ catheter offered by MEDTRONIC. One or more EM sensors on the catheter 110 detect the EM field generated by the antenna board 104. The navigation catheter 110 is connected to a navigation computer 112 including a memory, processors, a display and one or more applications stored in the memory and executable by the processor. One application that may be included is the ILLUMIS1TE™ navigation software offered by MEDTRONIC. The navigation computer 112 may be configured to receive and store pre-procedural images of the patient (e.g., computed tomography (CT) images, cone beam CT (CBCT), magnetic resonance (MRI) images, positron emissions tomography (PET), ultrasound (US), and others). One of the applications on the navigation computer 112 enables the review of the pre-procedural images, the identification of a tumor or lesion, and the generation of 3D models from the pre-procedural images. The 3D models are presented in a user interface on the display, and navigational pathways through the airways to targets (tumor or lesion).

[0020] Through a process of registration, locations within the airways of the patient can be matched to locations in the 3D models and pre-procedure images. As the navigation catheter 110 moves in the airways the EM sensor located thereon detects the EM field, and changes in the EM field generated by the antenna board 104. These changes in the EM field provide datapoints forming a point cloud representative of actual airways of the patient in its current location on the procedure table 102. That point cloud can be matched (registered) to the airways in the 3D model. Though described in connection with EM sensors, the disclosure is not so limited and a variety of alternative sensors including flexible sensors, Fiber-Bragg grating sensors, ultrasound sensors, thermocouples, accelerometers, gyroscopes, inertial measurement unit’s and other may be incorporated into the navigation catheter 110 without departing from the scope of the disclosure.

[0021] A representation of the navigation catheter 110 can be presented in the user interface on the 3D model and pre-procedure images. As the navigation catheter 110 is moved through the airways, the representation of the navigation catheter 110 as displayed in the user interface on the 3D model and the pre-procedure images moves in concert. Thus, the EM field, and the registrationallow a clinician to move the navigation catheter 110 through the airways of the patient without the need for camera-based visualization by following the pathway plan displayed in the 3D model.

[0022] In accordance with the disclosure, instead of or in addition to pre-procedural imaging a CBCT imaging system 114 can be employed. The CBCT imaging system 114 may be for example the 0-ARM™ CBCT imaging system offered by MEDTRONIC. The CBCT imaging system 114 is placed relative to the patient such that intraprocedural images of the patient can be acquired without interfering with the insertion of the bronchoscope 108 or navigation catheter 110. The CBCT imaging system 114 may be connected to the navigation computer 112, and intraprocedural images may be utilized as described above by the navigation application to identify targets (e.g., tumors and lesions), generate 3D models, and pathways to arrive at the targets in the 3D model all of which are presented on the user-interface in the display.

[0023] Though described in connection with a bronchoscope 108, the disclosure is not so limited, and instead the navigation catheter 1 10 may be part of a motorized or robotic drive system. The motorized or robotic drive system is configured to advance the navigation catheter 110 in the Z-direction (into the patient). The motorized or robotic drive system may be configured to rotate the navigation catheter 110 about its longitudinal axis. Still further, through the use of pull wires or the like the motorized or robotic drive system can articulate a distal portion of the navigation catheter 110 in at least one direction. An example of a motorized or robotic catheter drive mechanism can be seen in Fig. 2.

[0024] In Fig. 2, the catheter 110 is mounted on a sled 116. The sled 116 includes at least one motor 118 connected to a gear drive (e.g., a rack and pinion gear drive) that may also be manually manipulated by a rotation knob 120. Rotation of the knob 120 or driving of the motor 118 connected thereto advances the catheter 110 in the direction of the longitudinal axis of the catheter 110 (the Z-direction). As shown in Fig. 2, two motors 118, knobs 120 may be employed allowing two co-luminal catheters 110 (or a catheter 110 and a tool not shown) independent Z-direction movement, (e.g., so that one catheter 110 extends beyond the end of the other catheter 110). As will be appreciated, where instead the second motor 118 and knob 120 drives a tool, extension of a distal portion of the tool beyond the end of the catheter 110 is generally undertaken to perform the biopsy and collect a sample or deploy a therapy tool).

[0025] Another motor 118 is operably connected to a rotational gear drive 122. The rotation gear drive causes the catheter 110 to rotate on its longitudinal axis. Again, two such motors 118and rotational gear drive 122 may be employed where two catheters 110 or a catheter 110 and a tool are to be separately rotated.

[0026] Yet a third motor 118 may be connected to an articulation gear drive 124. The articulation gear drive 124 may be operably connected to an articulation mechanism, for example a pull-wire system or the like, to effectuate articulation of at least a distal portion of the catheter 110. Again, two such motors 118 and articulation gear drives 124 may be employed where two catheters 110 or a catheter 110 and a tool are to be separately articulated. In addition, each articulation gear drive 124 and rotational gear drive 122 may be manually manipulated via a rotation knob 120. As will be appreciated, the motors 118 may be connected to a controller (e.g., a gaming style controller) not shown for advancement, retraction, and articulation of the catheters 110 or a biopsy or therapy tool.

[0027] FIG. 3 depicts a simplified user interface 300 as might be presented on a display associated with the navigation computer 112. The user interface 300 presents a 3D model 302 including airways 304 leading to an area of interest 306. The area of interest 306 may include a number of targets 308. These targets are the locations within the area of interest 306 that are identified for biopsy or therapy. For example, these targets 308 may be identified at strategic locations throughout the area of interest, such that by taking a biopsy from each or at least a sufficient number of diverse locations a more accurate assessment of the area of interest 306 can be made. A number of pathways 310 for navigation of the biopsy and therapy tools are presented. These pathways define a path along with a biopsy tool or therapy tool, which may have very different mechanical properties (e.g., stiffness) than the navigation catheter 110, can be advanced from the navigation catheter 110 to arrive at the target 308. Each pathway 310 begins at a launch point 312. The launch point 312 defines a location within the airways 304 to which the navigation catheter 110 must be navigated to ensure that the biopsy or therapy tool (with its specific mechanical properties) can be advanced from the navigation catheter 110, along the pathway 310 to arrive at a given target 308. Navigation pathways 314, which may be presented in a different color or with some other distinguishing characteristic from the pathways 310 define the path along which the navigation catheter 110 must be navigated to arrive at the launch points 312.

[0028] As shown in FIG. 3, each target 308 is separately identified and may present a numerical order in which the biopsy is to be collected from each target 308. As shown with respect to the first two targets 308, they can be reached from a common launch point 312. While somereorientation of the navigation catheter 110 may be required to reach the second target 308 as compared to the first target 308, the physical location of the distal portion of the navigation catheter 110 is the same. Conversely, to reach the target 308 labeled as the third target, extra-luminal navigation may be required. Thus, from the launch point 312 to reach the third target 308, a tunneling catheter may be employed to pierce the wall of the airway 304, and to tunnel through the parenchyma and other tissue to arrive at the third target 308. The same is true for the fourth through the sixth targets 308.

[0029] Some targets 308 depicted in the user interface 300 include an X or some other indicator to the user that these targets 308 cannot be reached from the portion of the navigation path 314 depicted. Accordingly, the user may rotate the 3D model 302 in order to identify airways which arrive at or near the targets 308 which include the X. This may be continued until all of the targets 308 are connected via a pathway 310 to a launch point 312 and navigation pathway 314.

[0030] A dropdown menu 316 may be employed to allow a user to select a biopsy or therapy tool from the menu during navigation planning or even during a procedure. With a change in selection, the launch points 312 and the pathways 310 may change locations or shapes to accommodate the differing mechanical properties of each tool which are stored in a memory and accessible to the planning application operating on the navigation computer 112. The application ensures that the targets 308 can be reached by the biopsy or navigation tool. To further assist in planning rotation and zoom operators 318 enable changing the vie of the 3D model 302 in the user interface 300 to assist in identifying navigational pathways 314 such that all of the targets 308 can be reached by the navigational catheter 110 and a biopsy or therapy tool.

[0031] As noted elsewhere herein the navigation planning to reach the area of interest 306 and the targets 308 may be entirely automatic and performed by an application running on the navigational computer 112. In one example, the navigational computer 112 includes an application that can receive pre-procedural or intraprocedural images of the patient (e.g., CT or CBCT images) and analyze the images to identify an area of interest 306. Either automatically or with confirmation from a clinician, the meets and bounds of the area of interest can be identified in the images. A 3D model 302 of the airways 304 may be generated and navigation pathways 314 through the airways 304 to arrive at the area of interest 306 identified and displayed in the user interface 300.

[0032] Along with the navigational pathways 314, the application may automatically identify the targets 308 in the area of interest 306. Again, this identification may be confirmed by the clinician. Each target 308 may be associated with a particular tool (biopsy or therapy) that is to interact with the target 308. For example, the tool may be identified via the drop down 316. With the particular tool identified, the application can identify the launch points 312 and the pathways 310 for each identified tool to reach the target 308. As described above, the application may identify the order in which the targets 308 are to be biopsied.

[0033] During the biopsy an imaging system 114 (or alternatively a fluoroscope or ultrasound imaging system) may be employed to confirm the entry of the biopsy tool into the targets 308. Further, where the planning has been performed on pre-procedural images, to reduce incidents of CT-body divergence, intraprocedural images may be acquired from the imaging system 114. The planning in the pre-procedural images may be transferred to the intraprocedural images and adjusted as needed (again either automatically or manually by the clinician).

[0034] In yet a further aspect of the disclosure, in settings where rapid on-site evaluation (ROSE) of biopsy samples is available, a clinician may determine that in the best interest of the patient, the area of interest should immediately receive therapy. As such, using the plan with the targets 308 and the launch points 312, described above, the clinician may change the identified tool to a therapy tool. The application may, based on the change in tool, alter the launch points 312 to arrive at the targets 308. Additionally, or alternatively, the application may identify one or more new targets within the area of interest 306 at which therapy is to be applied. In addition, the application may identify new launch points 312 and pathways 310 for the therapy tool to reach the targets and apply therapy to the area of interest. As will be appreciated, each launch point 312 may relate to one or more position and orientation of the navigation catheter 110 to enable the collection of a sample or application of therapy to one or more targets 308. In this manner, without moving the position of the navigation catheter 110, the orientation may be changed such that a second or more target 308 can be sampled or treated from the single launch point 312.

[0035] Alternatively, with the pathway plan from the pre-procedural images having been used to collect biopsy sample from the area of interest, after laboratory confirmation that the area of interest requires therapy (e.g., after a week), the same plan can be utilized for the navigation of the navigational catheter 110 for purposes of applying therapy to the area of interest 306 in the patient. The plan may be modified prior to or during the subsequent navigation to adjust the launch points312, pathways 310, and targets 308 so that the therapy tool can arrive at desired locations within the area of interest to achieve the therapy.

[0036] In accordance with the disclosure, and when utilizing for example the robotic or motorized navigation catheter 110 as depicted in FIG. 2, the plan for arriving at the launch points 312 can be executed by the clinician selecting a “navigate catheter” button on the user interface. Once at a desired launch point 312, the user interface may present an indicator on the user interface that the launch point 312 has been arrived at and may request confirmation that the biopsy tool should be navigated along pathway 310 to arrive at one of the targets 308. This may be repeated until all of the launch points 312 have been navigated to and all of the targets 308 biopsied. A similar process may be undertaken for the application of therapy to the area of interest 306 and targets 308 within the area of interest 306.

[0037] Further the application on the navigational computer 112 may receive laboratory results and associate the results with the target 308 from which they were acquired. These results may provide further data regarding which portions of the area of interest require therapy and help to define a boundary around those targets 308 which require therapy to ensure that all targets 308 requiring therapy are adequately and appropriately treated.

[0038] FIG. 4 sets forth a method 400 in accordance with the disclosure. In accordance with the method, as shown in FIG. 4A, at step 402 images (e.g., CT or CBCT images) are accessed by an application running on navigational computer 112. At step 404 areas of interest 306 are identified in the images. This may be automatic or may be manually performed by scrolling through the images. Targets 308 are identified in the area of interest 306 at step 408. Again, the identification of targets may be manually performed or automatically as part of the application using, for example image processing and other criteria to ensure adequate sampling. At step 408 a 3D model of the airways is generated identifying the area of interest 306 and the targets 308 within the area of interest. At step 410 a navigational pathway 314 is generated through the airways of the patient to arrive at the area of interest 306. At step 412 a biopsy tool may be identified for accessing each target (e.g., using drop down 316 in user interface 300). As is known there are a variety of types of biopsy tools that may be employed, and each may have different mechanical properties. Once the tool is identified at step 414 the application can determine launch points 312 to which the navigational catheter is to be navigated and from which the biopsy tools may be advanced so that they can reach a specific target 308. At step 416 an order of targets 308from which to collect biopsies can be identified and displayed on the 3D model 302. At step 418, the navigation catheter 110 can be advanced to a first launch point 312. Advancement of the navigation catheter 110 may be manually or robotically performed. In the instance of a robotic driven navigation catheter the user interface may request confirmation that the clinician desires the navigation catheter to be driven to a first launch point 312, when received the application can send signals to drive the navigation catheter 110 to the launch point 312. Upon arrival at the first launch point 312 the application may display and indicator on the user interface 300 and inquire whether advancement of the biopsy tool from the navigation catheter is desired (e.g., in a robotic application) or indicate that manual advancement of the biopsy tool is now appropriate at step 420 to collect a biopsy from the first target 308. Following robotic or manual advancement of the biopsy tool to the target 308 the application may display an inquiry as to whether the biopsy has been collected from a first target 308 and whether reorientation or movement of the navigational catheter 110 to a location for collecting a biopsy sample from a second target 308 is desired at step 422. As noted above, in some instances two or more targets may be accessible from a single launch point 312 and all that is required is a reorientation of the distal portion of the navigation catheter 110. Alternatively, a subsequent target 308 may require the navigation catheter 110 to be moved to a new launch point 312, either robotically or manually. Accordingly, if the answer at step 422 is yes, the user interface 300 may display instructions for the manual adjustment of the orientation or location of the navigation catheter 110 or may robotically reorient or advance the catheter 110 to the desired position at step 424 and the method returns to step 420. If the answer is no at step 426 an inquiry is made whether method the biopsy portion of the procedure is being terminated. If yes at step 426 the biopsy portion of the procedure ends. If no at step 426 the method returns to step 422 to await confirmation that a biopsy of the first target has been acquired. The method steps 418-424 may be repeated until the clinician indicates that the biopsy portion of the procedure is being terminated. This termination may be due to collecting a biopsy at all or at least sufficient targets for the clinician’s purposes.

[0039] At step 428 an inquiry may be presented whether a therapy portion of a procedure should commence. If the response to the inquiry at 428 is not the entire procedure is terminated and the navigation catheter 110 may be manually or robotically withdrawn from the patient at step 430. Alternatively, if the response to the inquiry at step 428 is yes, the user interface 300 may display a request that a therapy tool be selected from the drop-down menu 316 at step 431 . Thetherapy tools may be, for example, one or more of a microwave ablation catheter, an RF ablation catheter, a cryo-ablation catheter, a chemical ablation catheter, etc. without departing from the scope of the disclosure. Once the therapy tool is selected the application, at step 432, automatically identify a target 308 within the area of interest 306 for application of therapy or may request the clinician identify one or more targets 308 for the application of therapy. With the targets 308 identified and the therapy tool selected, the application at step 434 can determine the launch point 312 to which the navigational catheter 110 need be navigated to and from which the therapy tool is to be advanced along the pathway 310 to arrive at the target 308 and can display the navigational pathway 314 to arrive at a launch point 312 from the current detected position of the navigational catheter 110. As described above, the targets 308 may be the same targets 308 at which the biopsies were acquired or may be at different locations within the area of interest 306 based on the therapy parameters of the therapy tool (e.g., shape of applied therapy, size of applied therapy, desired margin around area of interest, etc ). Similarly, the launch points 312 may be the same as utilized for the acquisition of the biopsy using the biopsy tools. However, due to the different mechanical properties of the therapy tool and the biopsy tool the launch points 312 may vary.

[0040] At step 436, the navigation catheter 110 can be advanced to a first launch point 312. Advancement of the navigation catheter 110 may again be manually or robotically performed. In the instance of a robotic driven navigation catheter 110 the user interface 300 may request confirmation that the clinician desires the navigation catheter 110 to be driven to a first launch point 312 and upon receiving confirmation drive the navigation catheter 110 to the launch point 312. Upon arrival at the first launch point 312 the application may display and indicator on the user interface 300 and inquire whether advancement of the therapy tool from the navigation catheter is desired (e.g., in a robotic application) or indicate that manual advancement of the therapy tool is now appropriate at step 438 to advance the therapy device to the target 308 following the pathway 310.

[0041] As shown in FIG. 4B, following robotic or manual advancement of the therapy tool to the target 308 intraprocedural imaging may be acquired at step 440 to confirm placement of the therapy tool within the area of interest and specifically at the target 308. At step 442 the application may display an inquiry as to whether the therapy tool is appropriately placed, and therapy should commence at step 444. If no, at step 444 the user interface can provide guidance on repositioning of the navigational catheter 110 or the therapy tool and the method returns to step 440. If yes, atstep 446 therapy can be applied to treat the area of interest 306. Following application of therapy, the application can determine whether there are additional targets 308, either from the same launch point 312 or additional launch points at step 448. If the answer to the inquiry at 448 is yes, the method returns to step 436, and steps 436-448 may be repeated until all targets 308 receive the therapy competing the treatment of the area of interest. If the answer at the inquiry is no, then the application, at step 450 displays an indication that the therapy portion of the procedure is complete and the therapy tool and navigation tool 110 may be manually or robotically withdrawn from the patient at step 452, where the method ends.

[0042] Though described hereinabove as an ordered series of steps, the steps of method 400 are not limited to their described sequence. One or more of the steps 400 may be eliminated or undertaken in a different order than as described herein without departing from the scope of the disclosure. As an example, step 408 may occur prior to steps 404 and 406, and the identification of the areas of interest 306 and the targets 308 may be made in the 3D model or the images. Similarly, steps 431-434 may be made intraprocedurally as outlined in method 400 of Fig. 4A, however, they may also be part of steps 404-416, and undertaken as part of the pre-procedural planning portions of the method. Other changes in order of one or more steps of method 400 may be contemplated without departing from the scope of the disclosure.

[0043] Reference is now made to FIG. 5, which is a schematic diagram of a system 500 configured for use with the methods of the disclosure including the method of FIG. 4. System 500 may be embodied on the navigational computer 112, or another platform capable of performing aspects of the disclosure described herein. System 500 may include a workstation 501, and optionally an imaging device 515 (e.g., CBCT, CT, or fluoroscopic imaging system). In some embodiments, workstation 501 may be coupled with imaging device 515, directly or indirectly, e g., by wireless communication. Workstation 501 may include a memory 502, a processor 504, a display 506 and an input device 510. Processor or hardware processor 504 may include one or more hardware processors. Workstation 501 may optionally include an output module 512 and a network interface 508. Memory 502 may store an application 518 and image data 514. Application 518 may include instructions executable by processor 504 for executing the methods of the disclosure including the method of FIG. 4.

[0044] Application 518 may further include a user interface 516. Image data 514 may include the CT scans, fluoroscopic images, 3D reconstructions, 3D models, or any other image data.Processor 504 may be coupled with memory 502, display 506, input device 510, output module 512, network interface 508 and imaging device 515. Workstation 501 may be a stationary computing device, such as a personal computer, or a portable computing device such as a tablet computer. Workstation 501 may embed a plurality of computer devices.

[0045] Memory 502 may include any non-transitory computer-readable storage media for storing data and / or software including instructions that are executable by processor 504 and which control the operation of workstation 501 and, in some embodiments, may also control the operation of imaging device 515. In an embodiment, memory 502 may include one or more storage devices such as solid-state storage devices, e.g., flash memory chips. Alternatively, or in addition to the one or more solid-state storage devices, memory 502 may include one or more mass storage devices connected to the processor 504 through a mass storage controller (not shown) and a communications bus (not shown).

[0046] Although the description of computer-readable media contained herein refers to solid- state storage, it should be appreciated by those skilled in the art that computer-readable storage media can be any available media that can be accessed by the processor 504. That is, computer readable storage media may include non-transitory, volatile, and non-volatile, removable and nonremovable media implemented in any method or technology for storage of information such as computer-readable instructions, data structures, program modules or other data. For example, computer-readable storage media may include RAM, ROM, EPROM, EEPROM, flash memory or other solid-state memory technology, CD-ROM, DVD, Blu-Ray or other optical storage, magnetic cassettes, magnetic tape, magnetic disk storage or other magnetic storage devices, or any other medium which may be used to store the desired information, and which may be accessed by workstation 501.

[0047] Application 518 may, when executed by processor 504, cause display 506 to present user interface 516. User interface 516 may be configured to present to the user a single screen including a three-dimensional (3D) view of a 3D model of the patient’s airways and include the area of interest from the perspective of a tip of a medical device. The user interface 516 may also display a live fluoroscopic image, for example to confirm the position of the therapy tool, as described above. The user interface may be presented on the display 506 and the display 506 may be a touch screen to receive inputs from a user. User interface 516 may be further configured to display the area of interest 306 and targets 308.

[0048] Network interface 508 may be configured to connect to a network such as a local area network (LAN) consisting of a wired network and / or a wireless network, a wide area network (WAN), a wireless mobile network, a Bluetooth network, and / or the Internet. Network interface 508 may be used to connect between workstation 501 and imaging device 515. Network interface 508 may also be used to receive image data 514. Input device 510 may be any device by which a user may interact with workstation 501, such as, for example, a mouse, keyboard, foot pedal, touch screen, and / or voice interface. Output module 512 may include any connectivity port or bus, such as, for example, parallel ports, serial ports, universal serial busses (USB), or any other similar connectivity port known to those skilled in the art. From the foregoing and with reference to the various figures, those skilled in the art will appreciate that certain modifications can be made to the disclosure without departing from the scope of the disclosure.

[0049] A further aspect of the disclosure is a method 600, useable particularly with robotic catheter systems and manual catheter systems, as depicted in Fig. 6. The method begins at step 602 where position of the sensor on the navigation catheter 110 is determined by the navigation application 518 on navigation computer 112 to be at a launch point 312. As will be appreciated the placement of the distal end of the navigation catheter 110 at the launch point 312 often requires articulation, sometimes significant articulation, of the navigation catheter 110 to orient the opening in the distal end of the navigation catheter 110 such that a biopsy or therapy tool extended from the navigation catheter 110 can interact with the area of interest 306 and targets 308.

[0050] At some point during the navigation of the navigation catheter 110 to a launch point 312 a biopsy or therapy tool is inserted into the navigation catheter 110. The type of tool being inserted is identified at step 604. This identification may be achieved by selecting it from a dropdown menu on a user interface, may be read by an optical sensor associated with the navigation catheter 110, or a sensed from an embedded chip via a chip reader associated with the navigation computer. Regardless of which system is employed, the identification of the tool results in data regarding the tool to be accessed by the navigation computer 112 at step 606. This may be accessing a look-up table or other data store associated with the navigation computing 112 and useable by the application 518 to determine aspects such as the maximum articulation the navigation catheter 110 and the tool 103 can traverse, an amount the articulation needs to be dearticulated to allow the tool to pass through an articulating portion of the navigation catheter 100, an amount the added stiffness of the tool will change the curvature of the articulation of thenavigation catheter 110, an amount of additional force needed to achieve an articulation of the tool similar that that of the navigation catheter 110, the amount of articulation that the navigation catheter 110 can experience without creating a friction fit that prevents the advancement of the tool even when past the articulation region, as well as other data related to the physical properties of the tool and its interaction with the navigation catheter 110.

[0051] At step 608 the position, amount of articulation, and a vector to a target 308 are recorded by the application 518. This recordation provides a point and an orientation to which the distal end of the navigation catheter 110 should be articulated to in order to allow the tool to interact with the area of interest 306 and targets 308. As the tool is advanced through the navigation catheter 110 the tool’s position within the navigation catheter 110 can be detected either through the use of a sensor to detect disruptions in the electromagnetic field or through the use of the optical sensor associated with the navigation catheter 110. At some point of advancement, the tool is detected at or near the articulation region at step 610. For example, this may be achieved by the use of multiple markings on the tool at known intervals and determination of the distance the tool has traveled within the navigation catheter 110 by counting the number of such markings to pass an optical sensor (e.g., an odometry measurement). Alternatively, an optical sensor pair may be employed to detect the distance that the tool travels through the navigation catheter 110. The optical sensor pair (one emitter and one detector) transmits light onto the tool. Based on a comparison of the detected properties of successive images captured by the detector, a determination can be made of the speed and distance that the tool has travelled within the navigation catheter 110. Where the optical sensor pair is a high-performance optical sensor there is no need for inclusion of any special patterns or other features on the exterior surface of the tool. In some instances, accurate distance and speed measurements can be made based on the minute variations in the surface of the tool, much the same way that an optical mouse can be used with a computer.

[0052] Once the tool is detected at or near the articulation zone at step 612 the application 518 can determine an amount of de-articulation of the navigation catheter 110 to allow the tool to pass the articulation zone of navigation catheter 110. Following the determination at step 612, the application 518 may at step 614 automatically drive and relax the articulation of the navigation catheter 110 to allow the tool to pass the articulation region and arrive at the distal end of the navigation catheter 110 without damaging an internal surface of the navigation catheter 110. Asan alternative the user interface (e g. 300) of the application 518 may display an amount of dearticulation at step 616 to enable passage of the tool. Whether manually operated or motor operated, the change in articulation required can be displayed on the user interface 516 awaiting the user to undertake the necessary steps to reduce the articulation to achieve the desired dearticulation. Once de-articulation is achieved, the tool can be advanced passed the articulation region, and the proximity of the tool to the distal end of the navigation catheter 110 can be detected at step 618. While the de-articulation and advancement of the tool 103 are undertaken, the images displayed on the user interface 416 can be adjusted at step 620. This adjustment to the user interface 516 may be to obscure the movement of the navigation catheter 110 during the de- articulation process. Obscuring the movement of the navigation catheter 110 may prevent the user from making the false assumption that the de-articulation is something that needs to be overcome or is an undesirable drift of the navigation catheter 110. For example, the user interface may be frozen during this process or obscured by an indicator stating that the de-articulation process is being undertaken to allow the tool to pass through the articulation region. Alternatively, the update rate of the images depicted on the user interface may simply be slowed and an indicator displayed on the user interface 516 to alert the user that a de-articulation process is being undertaken to allow the tool to pass through the articulation region. However, step 520 is optional and all of the movement of the navigation catheter 110 may be accurately displayed in the user interface 516 throughout the process to accurately display the movement of the navigation catheter 110 on the user interface 516 so that the user may follow the de-articulation and re-articulation process (e.g., steps 612-628).

[0053] After determination that the tool has passed the articulation region, at step 622 the catheter is re-articulated back to the same location and orientation with the same vector to the area of interest 306 and targets 308 as determined at step 608 prior to passage of the tool through the articulation region. This may be particularly employed where robotic or motorized articulation mechanisms, for example as described with respect to Fig. 2. Alternatively, where a manually operated systems is employed as shown in Fig. 1 or a motorized system receiving manual inputs, an indication is provided on the user interface 516 at step 624 directing the user to adjust the articulation of the navigation catheter 110 to re-orient the distal end of the navigation catheter 110 such that the opening at the distal end of the navigation catheter 110 is re-articulated back to thesame location and orientation with the same vector to the area of interest 306 and targets 308 as determined at step 608 prior to passage of the tool through the articulation region.

[0054] At step 626 the position and orientation of the distal end of the navigation catheter 110 and tool at the location and orientation with the same vector to the target location as determined at step 608 is detected. At step 628 an indication of realignment with the area of interest 306 and targets 308 can be displayed on the user interface 516. Once achieved, the user is free to perform a procedure at the target location, e.g., biopsy or therapy or some other procedure relevant to the patient at step 630. After performance of the procedure, at step 632 a determination can be made whether de-articulation is required for removal of the tool 105. If not, the process advances to step 640.

[0055] If, however, de-articulation is needed at step 632, for example based on the data referenced in step 606, the navigation catheter 110 may be de-articulated at step 534. Alternatively, an indication of the amount of de-articulation necessary can be displayed on the user interface 416 at step 636 allowing the user to either drive the motorized systems or manually manipulate the articulation of the navigation catheter 110. At step 638 sufficient de-articulation of the navigation catheter 110 is detected and at step 640 an indication can be displayed on the user interface 516 that the tool can safely be removed. At step 642 a determination is made as to whether there are additional locations within the body to navigate to (e.g., additional area of interest 306 and targets 308). If no other locations require navigation to the procedure may end. Alternatively, if the catheter 110 needs to be navigated to other area of interest 306 and targets 308, the navigation catheter 110 can be so navigated and detection of the navigation catheter 110 proximate the area of interest 306 and targets 308 can be again detected (step 602), and the process repeated until all area of interest 306 and targets 308 have been navigated to and the desired procedure performed.

[0056] Though method 600 is generally directed to distal articulation of the navigation catheter 110, the disclosure is not so limited and the methods described herein may be encompassed in catheters which are articulable along greater portions of their length. Still further, aspects of the points of de-articulation can be determined during the planning phase (e.g., steps 402-416 of method 400). For example, as part of identification of the biopsy tool (step 412) and launch points step 414) the application may identify locations along the navigation pathway (step 410) where the tool will have to pass through a de-articulated navigation catheter 110. In some instances thesede-articulation points may be prior to arriving at the launch points 312. The points for dearticulation may be stored in the memory as part of the navigation plan. During navigation one or more indicators may be presented on the user interface 516 alerting the user of the need to advance the tool within the de-articulated navigation catheter 110, prior to continuing advancement of the navigation catheter 110 to the launch point 312. As will be appreciated with a robotic system, the tool may be automatically advanced upon the navigation catheter 110 reaching one of the dearticulation points, and once the tool passes through the articulation region of the navigation catheter 110, advancement of the navigation catheter 110 can continue.

[0057] Further, any of the steps of methods 400 and 600 may be performed out of order or even omitted without departing from the scope of the disclosure. Accordingly, the application 518 may store or have access to data relating to either clinician tool preferences or tool inventory. Accordingly, the identification of the launch points 312 (e.g., step 414) may be based on clinician preferences for tools to be employed (e.g., biopsy needles vs brushes vs. graspers, etc.) thus two or more alternative sets of launch points may be identified based on the clinician preferences in tools and the selection of the biopsy tool (step 412) may occur only after identification of the alternatives for launch points (step 414). Further, rather than clinician preferences, the alternative launch points 312 may be presented based on the available inventory of tools to be used during the procedure.

[0058] Still further, based on the location of the area of interest 306 and targets 308, and pathways to the launch points 312, the application 518 may eliminate certain tools from being selectable by the clinician based either on the dimensions and mechanical properties and characteristics of the tools. This may be at least in part due to a determined inability to de-articulate the navigation catheter 110 sufficiently to enable advancement of the tool through the navigation catheter 110 to arrive at the launch site 312. Still further, the application 518 may having tracked the advancement of the navigation catheter 110, and present an indicator relating to clinician’s preferred tools and whether any of the preferred tools can be advanced through the navigation catheter 110 based on the actual sensed articulation of the navigation catheter 110 within the patient. Those of skill in the art will recognize that while the planned pathway may have enabled certain tools to pass through the navigation catheter 110, once the navigation catheter 110 is inserted into the patient, the actual bends and articulation required to navigate within the patient may be different than planned, and a planned tool or launch point 312 may no longer be feasible.

[0059] Thus, as part of the planning, the clinician can be assured that they are able to utilize the tools that they prefer (even if based on limited inventory selection) and they are able to confirm that the tool can be navigated through the navigation catheter 110 (potentially with identified dearticulation points) to arrive at launch points 312 where they have confidence that the desired area targets 308 can be sampled or treated.

[0060] In accordance with aspects of the disclosure, the de-articulation of the navigation catheter 110 may be automatically controlled by the application 518 and undertaken during the advancement of tools.

[0061] 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. Therefore, the above description should not be construed as limiting, but merely as exemplifications of particular embodiments.

Claims

WHAT IS CLAIMED IS:

1. A system for endoluminal navigation comprising; a catheter configured for navigation within a luminal network of a patient; a sensor associated with a distal portion of the catheter and outputting a signal; and a computing device including a memory, a processor, and a display, the memory storing instructions that when executed by the processor: receive imaging of the luminal network; receive an indication of an area of interest within the imaging; receive an indication of a plurality of targets within the area of interest for sampling; generate and display, on a user interface, a three-dimensional (3D) model of the luminal network; generate a navigational pathway through the luminal network to the area of interest; and generate a plurality of launch points along the navigational pathway, each launch point defining a location and orientation of the catheter such that a biopsy tool extended from the catheter will impact at least one target of the plurality of targets in the area of interest associated with the launch point.

2. The system of claim 1, wherein the computing device stores instructions that when executed by the processor determines an order for each of the plurality of targets to be sampled.

3. The system of any of the preceding claims wherein the computing device stores instructions that when executed by the processor receives via the user interface an indication of an identity of biopsy tool.

4. The system of any of the preceding claims wherein the computing device stores instructions that when executed by the processor receive the signal from thesensor and presents, on the user interface, a location of a distal portion of the catheter on the 3D model of the luminal network.

5. The system of any of the preceding claims wherein the computing device stores instructions that when executed by the processor generates a pathway from each of the plurality of launch points to at least one target of the plurality of targets.

6. The system of claim 5, wherein the pathway extends from one of the plurality of launch outside of the luminal network to reach the at least one target.

7. The system of any of the preceding claims wherein the computing device stores instructions that when executed by the processor receives intraprocedural images and receives a confirmation that a biopsy tool is placed within at least one target of the plurality of targets.

8. The system of any of the preceding claims wherein the computing device stores instructions thereon that when executed by the processor receives an indication that a biopsy sample has been collected and presents instructions for reorientation or advancement of the catheter to a second launch point.

9. The system of any of the preceding claims, wherein the catheter is robotically driven catheter.

10. The system of any of the preceding claims wherein the computing device stores instructions thereon that when executed by the processor identifies the area of interest in the imaging of the luminal network and presents a request for confirmation on the user interface.

11. The system of any of the preceding claims wherein the computing device stores instructions thereon that when executed by the processor identifies at least one of the plurality of targets within the area of interest and presents a request for confirmation on the user interface.

12. A method of planning endoluminal navigation comprising; receiving imaging of a luminal network; receiving an indication of an area of interest within the imaging; receiving an indication of a plurality of targets within the area of interest for sampling;generating and display, on a user interface, a three-dimensional (3D) model of the luminal network; generating a navigational pathway through the luminal network to the area of interest on the user interface; and generating a plurality of launch points within the 3D model along the navigational pathway, each launch point defining a location and orientation of a catheter such that a biopsy tool extended from the catheter will impact at least one target of the plurality of targets in the area of interest associated with the launch point.

13. The method of claim 12, further comprising determining an order in which each of the plurality of targets will be sampled.

14. The method of any of claim 12-13 further comprising receiving, via the user interface, an indication of an identity of a biopsy tool.

15. The method of claim 12-14 further comprising receiving a signal from a sensor on the catheter and presenting in the user interface a location of a distal portion of the catheter in the 3D model.

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