System and method for endoluminal peripheral lung nodule access

Abstract

A system for endoluminal navigation including a navigation catheter configured for insertion into a luminal network of a patient, a cone-beam computed tomography (CBCT) imager configured to capture CBCT images of the luminal network, and a memory operably connected to a processor, the memory storing instructions that when executed receive an initial intraprocedural CBCT scan from the CBCT imager, wherein the CBCT scan includes a plurality of CBCT images, identify a location of a target in the CBCT images, generate a three-dimensional (3D) model from the CBCT images, determine a location of the navigation catheter in the CBCT images, generate a pathway from the determined location of the navigation catheter through the 3D model to the location of the target, determine whether a subsequent intraprocedural CBCT scan is recommended, and output a signal for display in a user interface that the subsequent intraprocedural CBCT scan is recommended.

Description

SYSTEM AND METHOD FOR ENDOLUMINAL PERIPHERAL LUNG NODULE ACCESSCROSS-REFERENCE TO RELATED APPLICATION(S)

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 549,096, filed February 2, 2024, which is incorporated herein by reference in its entirety.BACKGROUNDTechnical Field

[0002] This disclosure relates to the field of endoluminal navigation and particularly with endoluminal navigation of catheters and tools to peripheral locations within the airways of a patient.Description of Related Art

[0003] There are several commonly applied medical methods, such as endoscopic procedures or 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 (US) imaging, computed tomography (CT), cone-beam computed tomography (CBCT), or fluoroscopy (including 3D fluoroscopy) are employed by clinicians to identify and navigate to areas of interest within a patient and ultimately a target for biopsy or treatment. These pre-operative scans may be utilized for target identification and intraoperative guidance.

[0004] Regardless of the fidelity of the pre-operative scans, real-time imaging may still be required to the dynamic movement of the target area. Furthermore, real-time image data displaying the current location of a medical device with respect to the target and its surroundings may be needed to navigate the medical device to the target in a safe and accurate manner (e.g., without causing damage to other organs or tissue).

[0005] For example, an endoscopic approach has proven useful in navigating to areas of interest within a patient. To enable the endoscopic approach endoscopic navigation systems have been developed that use previously acquired MRI data or CT image data to generate a three-dimensional (3D) rendering, model, or volume of the particular body part such as the lungs. However, as is known these pre-operative scans, and the 3D models rendered from them typically do not accurately represent the actual placement and orientation of the organs of the patient duringthe procedure. In part this is due to the fact that the procedure may occur days or even weeks after the acquisition of the images. The discrepancy in the actual placement and orientation compared to the pre-operative scans is known as CT-to-body divergence.

[0006] To address the CT-to-body divergence intra-operative scans such as fluoroscopic scans are often employed. These may be in the form of 2D imaging of the relevant portion of the patient. However, 2D images have their limitations, mainly the inability to easily determine depth in the 2D image. More recently tomosynthesis has been employed to generate a 3D volume from a sweep of 2D images and provide better context for the relative position of tools or a target within the patient. However, improvements to the existing endoluminal navigation systems and methods are desired.SUMMARY

[0007] One aspect of the disclosure is an endoluminal navigation system including a navigation catheter configured for insertion into a luminal network of a patient. The system also includes a cone-beam computed tomography (CBCT) imager configured to capture CBCT images of the luminal network; and a memory operably connected to a processor, the memory storing instructions that when executed by the processor perform steps of: receive an initial intraprocedural CBCT scan from the CBCT imager, where the CBCT scan includes a plurality of CBCT images; identify a location of a target in the CBCT images; generate a three-dimensional (3D) model from the CBCT images; determine a location of the navigation catheter in the CBCT images; generate a pathway from the determined location of the navigation catheter through the 3D model to the location of the target; and determine whether a subsequent intraprocedural CBCT scan is recommended; and if it is determined that the subsequent intraprocedural CBCT scan is recommended, output a signal for display in a user interface that the subsequent intraprocedural CBCT scan is recommended. 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.

[0008] Implementations may include one or more of the following features. The system where the subsequent CBCT scan is recommended when a time since the initial intraprocedural CBCT scan exceeds a threshold. The navigation catheter includes a location sensor operable to output a signal indicative of a location within the luminal network. The subsequent CBCT scan is recommended when the navigation catheter is within a threshold distance of the target. The sensoris an electromagnetic (EM) sensor configured to detect an EM field generated around the patient. The sensor is a fiber-bragg shape sensor. The navigation catheter includes a force sensor configured to detect a force applied to the navigation catheter. The subsequent CBCT scan is recommended when the force applied to the navigation catheter exceeds a threshold. The subsequent CBCT scan is recommended when the force applied to the navigation catheter does not equate to a change in location of the location sensor. The memory stores instructions that when executed by the processor perform a step of receiving a subsequent intraprocedural CBCT scan. The subsequent intraprocedural CBCT scan is registered to the initial intraprocedural CBCT scan. The navigation catheter is motorized. The navigation catheter is robotically driven. Implementations of the described techniques may include hardware, a method or process, or computer software on a computer-accessible medium.

[0009] A further aspect of the disclosure includes a method of navigating a navigational catheter within a luminal network. The method includes advancing a navigational catheter to a first location within a luminal network; acquiring an initial intraprocedural cone-beam computed tomography (CBCT) scan includes a plurality of CBCT images; identifying a location of a target in the CBCT images; generating a three-dimensional (3D) model from the CBCT images; determining a location of the navigation catheter in the CBCT images; generating a pathway from the determined location of the navigation catheter through the 3D model to the location of the target; and determining whether a subsequent intraprocedural CBCT scan is recommended; and if it is determined that the subsequent intraprocedural CBCT scan is recommended, output a signal for display in a user interface that the subsequent intraprocedural CBCT scan is recommended. 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.

[0010] Implementations may include one or more of the following features. The method where the subsequent CBCT scan is recommended when a time since the initial intraprocedural CBCT scan exceeds a threshold. The subsequent CBCT scan is recommended when the navigation catheter is within a threshold distance of the target. The subsequent CBCT scan is recommended when a force applied to the navigation catheter exceeds a threshold. The subsequent CBCT scan is recommended when a force applied to the navigation catheter does not equate to a change in location of a location sensor. The method may include receiving a subsequent CBCT scan. Themethod may include detecting with an electromagnetic sensor a change in location of the navigation catheter in an electromagnetic field generated around the luminal network. 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

[0011] Various aspects and embodiments of the disclosure are described hereinbelow with references to the drawings, wherein:

[0012] FIG. 1 is a schematic view of a cone-beam imaging and endoluminal navigation system in accordance with the disclosure; and

[0013] FIG. 2 is a flow chart depicting a method of utilizing the systems of FIG. 1 in accordance with the disclosure.DETAILED DESCRIPTION

[0014] The disclosure is directed to an endoluminal navigation system that substantially eliminates the occurrence of CT-to-body divergence and reduces personnel and patient exposure to radiation. Though aspects of the disclosure are focused on endoluminal lung navigation, the disclosure is not so limited and may be employed in other procedures requiring endoluminal navigation (e.g., intestinal, venous, biliary, and other luminal networks). In accordance with aspects of the disclosure the system employs a cone-beam CT (CBCT) imaging system. During a procedure, a catheter to driven into the luminal network of the patient, this may be to for example a second or third bifurcation of the lungs, an area to which most bronchoscopes and catheters (whether manual or robotic) can be driven using traditional white light illumination. Once the catheter is placed within the patient, the CBCT imaging system may capture a CBCT scan of the patient.

[0015] Unlike traditional pre-procedure CT images, which are captured with the patient’s lungs at full breath hold, the CBCT scan can be acquired with a breath hold at a point during tidal volume breathing. The patient, during a procedure, is ventilated thus the volume of air and the volume, frequency, and speed at which air exchanges are undertaken can be closely controlled. Thus, for example, the CBCT scan may be acquired during a breath hold at or near the maximum inspiration for the ventilation settings of the patient.

[0016] Because the CBCT scan is acquired with the catheter in the patient, and with the patient in the position they will be during the remainder of the procedure, the CBCT scan (a series images) and any 3D model generated from the CBCT scan is necessarily registered to the patient since the patient is in the same position during the procedure as during the imaging. This of course assumes the CBCT imaging system is in either a fixed location relative to the patient or is configured such that the position can be accurately returned to a position at which the images are acquired.

[0017] Where a navigation system (e.g., electromagnetic (EM), fiber-bragg (flex sensor), or other) is employed, the shape of the catheter or the path the catheter has already traversed is knowable and can be used to register the sensor system (e.g., the EM field and the position of the EM sensor in that field) with the CBCT scan and the 3D model generated therefrom. This registration exceeds the registration of pre-procedural CT (or other modality) images and 3D models generated from these pre-procedural images to the patient, not least because there is no initial CT-to-body divergence. As such navigation of the catheter to a target within the patient utilizing the CBCT scan and 3D models generated therefrom can continue with confidence.

[0018] Despite the elimination of CT-to-body divergence, at least initially in the procedure, as the catheter and other tools are navigated within the lungs of the patient a variety of factors can nonetheless result in changes to the shape of the patient’s lungs. As an example, atelectasis, deflation of the lungs can result in changes in shape of certain portions of the lungs, despite continued ventilation. As navigation of the catheter continues to the periphery, the airways decrease in size to the point where the airway is substantially blocked by the catheter and as a result only limited air may be forced into those peripheral portions of the airway. Despite the limited ingress of air to the substantially blocked periphery, air already within the periphery may over time continue to leak from the airway, resulting in the collapse of those portions of the lung. This collapse or atelectasis changes the shape of the affected portions of the lung.

[0019] Similarly, as the airways get smaller, forces applied by the catheter or other tools that may be inserted into a lumen of the catheter, are transferred to the lungs. The lungs being generally pliable, particularly beyond the central airways thus have their shape changed during the navigation of the catheter or other tools. That change in shape alters thus results in incongruities between the 3D models and pathway plans developed from the CBCT scan and the real shape and orientation of the airways of the patient. These incongruities can lead to instances where biopsiesare taken at different locations than where they were attended, or therapy being applied to different portions of a tumor or lesion that intended.

[0020] This disclosure relates to systems and methods, where following the CBCT scan, and during navigation of the catheter one or more alerts are provided to the clinician indicating that a further CBCT scan, potentially of a smaller portion of the patient, is appropriate to ensure accurate navigation of the catheter to the target. The basis for these alerts may be as simple as the time since the last CBCT scan. Alternatively, time may in some instances be a primary factor in alerting a clinician to a change in shape of the lungs caused by atelectasis. Additionally, or alternatively, the alert may be based on a magnitude of a force applied by the catheter or tools on the lungs of the patient. When the force applied to the lungs or airways exceeds a certain magnitude an indication may be presented to the clinician that a threshold has been overcome indicating that the shape of the lungs has likely changed from the shape the lungs had during the most recent CBCT scan. In such instances, an alert may be displayed on a user interface indicating that a further CBCT scan may benefit the procedure. As in all such systems, the alerts are provided for the purpose of alerting the clinician to potential actions that might be undertaken to help ensure that a successful procedure is achieved.

[0021] 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 identified in images which assists 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 a camera allowing for visual navigation of the airways of the lungs. However, as will be appreciateda bronchoscope 108 cannot be navigated all the way to the periphery of the lungs where the airways are quite small.

[0022] 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 108 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 ILLUMISITE™ 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).

[0023] 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.

[0024] 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 registration allow 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.

[0025] However, as noted above, when utilizing pre-procedure images and a 3D model generated from the pre-procedure images there is necessarily CT-to-body divergence. That CT- to-body divergence results in misrepresentation of the location of the navigation catheter 110 inthe 3D model compared to actual location of the navigation catheter 110 within the patient. Thus, intraprocedural images (e.g., fluoroscopy) have become a standard feature of these lung navigation procedures. However, as noted above, fluoroscopy results generally have reduced resolution than other imaging techniques, often limited to just 2D images showing the location of the navigation catheter 110 within the patient. And though tomosynthesis methods, in which a 3D volume is generated from a series of 2D fluoroscopic images, have been developed the negative effects of the radiation from the fluoroscope and the need to wear lead shielding remains.

[0026] Though described in connection with a bronchoscope 108, the disclosure is not so limited, and instead the navigation catheter 110 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.

[0027] In accordance with the disclosure, instead of or in addition to pre-procedural imaging, a CBCT imaging system 114 can be employed instead of a fluoroscope. 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.

[0028] In accordance with aspects of the disclosure, FIG. 2 shows a flow chart depicting a method of utilizing the system of FIG. 1. A clinician may optionally acquire pre-procedural images (e.g., CT images) at step 202, identify targets in the pre-procedural images at step 204, and generate a 3D model of the patient’s lungs, and a navigation pathway through the 3D model of the patient’s lungs to arrive at the target at step 206. The imaging, 3D model, and navigation pathway may be communicated to a navigation computer 112 for use with the navigation applications at step 208, as described above.

[0029] Using the generated navigation plan, along with setting up the remainder of the system 100, the 3D model, pathway, and plan can be loaded via an application on the navigation computer 112 so that they are displayed in the user interface at step 210. The 3D model and plan are then registered with the patient at step 212. At step 214 the navigation catheter 110, either robotically or manually via the bronchoscope 108, is advanced into the airways of the patient and towards the target.

[0030] As noted above, steps 202-212 may be optional and are therefore not required for the method 200. In accordance with the disclosure, the clinician may have received an indication of the general location of a target (tumor or lesion), for example that it is located in the right upper lobe or within a segment distal of the third bifurcation. This general knowledge may be from viewing the pre-procedure images, or it may have been provided from another source (e.g., another physician), or have been identified previously and a process of watchful waiting undertaken. Still further, if a patient previously had a tumor or lesion biopsied or treated, it may be decided that periodically a combined imaging and biopsy be undertaken. With any of these in mind, advancement of the navigation catheter 110 into the airways of the patient at step 214, may be the first step of method 200. As noted above, that navigation can be under white light illumination as is commonly performed with a bronchoscope. Once the navigation catheter 110 is advanced some distance into the airways of the patient, at step 216 a CBCT scan is performed, and images are acquired using the CBCT imaging system 114.

[0031] The CBCT scan of the patient with the navigation catheter 110 within the airways of the patient provides a number of advantages over the pre-procedure images. First, the lungs of the patient are not at a full breath hold, but rather inflated to a level within the range of tidal volume breathing undertaken during the procedure. Thus, the lungs themselves are substantially in the same position as they will be during the remainder of the procedure. Accordingly, a 3D model generated from the CBCT images will more closely match the shape and location of the lungs of the patient. Further, because the navigation catheter 110 is within the patient, it can be identified in the CBCT scan images to accurately register the CBCT scan images and the 3D model generated therefrom to the actual position and orientation of the lungs within the patient. Thus, when the navigation catheter 110 is advanced, the changes in the EM field from the antenna board 104, can be accurately reflected in the displayed changes in location of the representation of the navigation catheter 110 in the 3D model and CBCT images on the user interface presented on the display.

[0032] Accordingly, following capture of the CBCT scan images, a 3D model of the airways is generated at step 218. The images can then be reviewed in an application on the navigation computer 112 and the targets identified (e.g., tumors or lesions) at step 220. The identification of the targets can be manually performed by the clinician reviewing the images or may be automatically performed via image analysis features in the application on the navigation computer 112 and confirmed by the clinician. With the targets identified, pathways from the location of the navigation catheter 110 to the targets can be generated at step 222 by the application on the navigation computer 112. Again, the pathway may be manually identified or may be automatically generated by the application and accepted by the clinician. The generated pathways may take a variety of factors into account including portions of the target from which biopsies are to be taken or which are to receive therapy, position the navigation catheter 110 need to be located in order for a particular tool to reach a specified location on the target for biopsy or therapy, the bend capabilities of the navigation catheter 110 and / or the biopsy and therapy tools, and other factors.

[0033] With the 3D model generated, the targets and the pathways identified, and due to the CBCT scan being acquired with the patient in the same position they will be in for further advancement of the navigation catheter 110, the 3D model and the patient are registered, and advancement of the navigation catheter 110 to the target can continue at step 224. Further, as noted above, the antenna board 104 may include a plurality of markers that can be identified in the images and can assist in registration of any subsequent CBCT scans to the original CBCT scan (if necessary). And since the path of the navigation catheter 110 may be known to arrive at the point at which it is located in the CBCT scan images, a plurality of sensor locations (e.g., EM sensor locations in the EM field) can be used to register the EM field to the patient and the CBCT scan such that movement of the navigation catheter 110 can be accurately translated and displayed in the CNCT images or the 3D model as it is advanced to the target.

[0034] As the navigation catheter 110 is being advanced to the target, a series of inquiries are made regarding the procedure. At step 226, a first determination is made of the time since the last CBCT. If the time since the last CBCT exceeds a threshold, an indicator may be displayed in the user interface suggesting that a fresh CBCT scan be undertaken, and the method returns to step 216. If the time has not been exceeded, the method returns to step 224 where the catheter 110 continues to be advanced. As noted above, time may be a factor in indicating that the lung has undergone atelectasis and that the airways may not be in the locations they were in during theoriginal CBCT scan, thus 3D model and the relative position of the representation of the navigation catheter 110 displayed in the 3D model may not be sufficiently accurate to ensure accurate collection of a biopsy or application of therapy.

[0035] Similarly, and particularly where the navigation catheter is motorized or robotically driven, at step 228 the amount of force applied to the navigation catheter 110 can be monitored. For example, the power required to drive a motor for Z-direction advancement can be monitored and when it exceeds a threshold it can be determined that force in excess of a threshold is being applied to the tissue of the airways in excess of a threshold. If the force applied has not exceeded the threshold, the method returns to step 224 where the catheter 110 continues to be advanced. Additionally, or alternatively, at step 230 the force applied by the motor driving the navigation catheter 110 can be compared to the magnitude of the movement of the sensor within the EM field to determine that force is being applied to the airways that can change the shape of the airways or result in unintentional piercing of the airway wall. This comparison may also reveal when as a result of the tortuous path of the navigation catheter 110 within the airways, application of force to the navigation catheter results in buckling of the navigation catheter. This can be observed when the applied force does not exceed a threshold, but also does not result in movement of the sensor located on a distal portion of the navigation catheter 110. When such a determination is made an indicator may be presented in the user interface suggesting that a new CBCT scan be undertaken. If acted on by the clinician, the method again returns to step 216 for acquisition of a CBCT scan. Where the determination at step 230 is that the force applied is equal to or substantially equal to the distance moved, the method returns to step 224 where advancement of the catheter 110 continues. As will be appreciated, the navigation catheter 110 may also include one or more force sensors for detection of the force applied to the navigation catheter 110 during navigation. The force sensor may be on a distal portion proximate to the EM sensor, a proximal portion such as a handle gripped by a clinician, or there may be multiple along the length of the navigation catheter.

[0036] Further, when the navigation catheter 110 is determined at step 232 to be within a specified distance from the target (e.g., about 3 cm) the method 200 may suggest that a second CBCT scan be undertaken. Even where the initial CBCT scan was acquired more recently than the threshold time, and the force applied to navigation catheter is below the threshold the advancement of the navigation catheter 110 through the tortuous path of the airway maynevertheless result in a change of shape of the airway leading to a divergence in the actual shape of the airways and the shape of the 3D model. Accordingly, a further CBCT scan may be suggested during every procedure. Where the determination at step 232 is that the catheter 110 is not within a specified distance from the target, the method returns to step 224 where advancement of the catheter 110 continues.

[0037] The method 200 may be continued until the navigation catheter 110 arrives proximate the target and either a biopsy tool or a therapy tool is deployed to collect a biopsy or apply a therapy to the target. The therapies may include cryotherapy ablation, microwave ablation, radiofrequency ablation, chemical ablation, and others without departing from the scope of the disclosure.

[0038] In addition to the features of method 200 described above, when the methods and systems of this disclosure are utilized in conjunction with robotic application additional assessments of an EM field generated about the patient can be ascertained. For example, when a robotic drive system is employed the navigation catheter 110 can be driven to a first point and EM data collected about that location. The navigation catheter 110 can be advanced to a second point and again EM data collected about the second location. At any time, the navigation catheter 110 may be retracted to the first point again and EM data once again collected. Changes in the EM data (e.g., detected location or orientation of the navigation catheter) at the first point from the first instance and the second instance can be compared. This comparison may provide data relating to changes in the EM field, changes in the position and orientation of the luminal network (e.g., caused by the navigation catheter 110) or other causes of divergence of that location over time. As will be appreciated, understanding these divergences can provide a further basis for suggesting that a further CBCT scan be undertaken.

[0039] 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.

[0040] Aspects of this disclosure may be further described by reference to the following examples:

[0041] Example 1. A system for endoluminal navigation comprising: a navigation catheter configured for insertion into a luminal network of a patient; a cone-beam computed tomography (CBCT) imager configured to capture CBCT images of the luminal network; and a memoryoperably connected to a processor, the memory storing instructions that when executed by the processor perform steps of: receiving an initial intraprocedural CBCT scan from the CBCT imager, wherein the CBCT scan includes a plurality of CBCT images; identifying a location of a target in the CBCT images; generating a three-dimensional (3D) model from the CBCT images; determining a location of the navigation catheter in the CBCT images; generating a pathway from the determined location of the navigation catheter through the 3D model to the location of the target; and determining whether a subsequent intraprocedural CBCT scan is recommended; and if it is determined that the subsequent intraprocedural CBCT scan is recommended, output a signal for display in a user interface that the subsequent intraprocedural CBCT scan is recommended.

[0042] Example 2. The system of example 1 , wherein the subsequent intraprocedural CBCT scan is recommended when a time since the initial intraprocedural CBCT scan exceeds a threshold.

[0043] Example 3. The system of example 1, wherein the navigation catheter includes a location sensor operable to output a signal indicative of a location within the luminal network.

[0044] Example 4. The system of example 2, wherein the subsequent intraprocedural CBCT scan is recommended when the navigation catheter is within a threshold distance of the target.

[0045] Example 5. The system of example 3, wherein the location sensor is an electromagnetic (EM) sensor configured to detect an EM field generated around the patient.

[0046] Example 6. The system of example 3, wherein the location sensor is a fiber-bragg shape sensor.

[0047] Example 7. The system of example 2, wherein the navigation catheter includes a force sensor configured to detect a force applied to the navigation catheter.

[0048] Example 8. The system of example 7, wherein the subsequent intraprocedural CBCT scan is recommended when the force applied to the navigation catheter exceeds a threshold.

[0049] Example 9. The system of example 7 wherein the subsequent intraprocedural CBCT scan is recommended when the force applied to the navigation catheter does not equate to a change in location of the location sensor.

[0050] Example 10. The system of example 1, wherein the memory stores instructions that when executed by the processor perform a step of receiving a subsequent intraprocedural CBCT scan.

[0051] Example 11. The system of example 10, wherein the subsequent intraprocedural CBCT scan is registered to the initial intraprocedural CBCT scan.

[0052] Example 12. The system of example 1, wherein the navigation catheter is motorized.

[0053] Example 13. The system of example 1, wherein the navigation catheter is robotically driven.

[0054] Example 14. A method of navigating a navigational catheter within a luminal network comprising: advancing a navigational catheter to a first location within a luminal network; acquiring an initial intraprocedural cone-beam computed tomography (CBCT) scan includes a plurality of CBCT images; identifying a location of a target in the CBCT images; generating a three-dimensional (3D) model from the CBCT images; determining a location of the navigation catheter in the CBCT images; generating a pathway from the determined location of the navigation catheter through the 3D model to the location of the target; and determining whether a subsequent intraprocedural CBCT scan is recommended; and if it is determined that the subsequent intraprocedural CBCT scan is recommended, output a signal for display in a user interface that the subsequent intraprocedural CBCT scan is recommended.

[0055] Example 15. The method of example 14, wherein the subsequent intraprocedural CBCT scan is recommended when a time since the initial intraprocedural CBCT scan exceeds a threshold.

[0056] Example 16. The method of example 14, wherein the subsequent intraprocedural CBCT scan is recommended when the navigation catheter is within a threshold distance of the target.

[0057] Example 17. The method of example 14, wherein the subsequent intraprocedural CBCT scan is recommended when a force applied to the navigation catheter exceeds a threshold.

[0058] Example 18. The method of example 14, wherein the subsequent intraprocedural CBCT scan is recommended when a force applied to the navigation catheter does not equate to a change in location of a location sensor.

[0059] Example 19. The method of example 14, further comprising receiving the subsequent intraprocedural CBCT scan.

[0060] Example 20. The method of example 14, further comprising detecting, with an electromagnetic sensor, a change in location of the navigation catheter in an electromagnetic field generated around the luminal network.

Claims

We claim:

1. A system for endoluminal navigation comprising: a navigation catheter configured for insertion into a luminal network of a patient; a cone-beam computed tomography (CBCT) imager configured to capture CBCT images of the luminal network; and a memory operably connected to a processor, the memory storing instructions that when executed by the processor perform steps of: receiving an initial intraprocedural CBCT scan from the CBCT imager, wherein the CBCT scan includes a plurality of CBCT images; identifying a location of a target in the CBCT images; generating a three-dimensional (3D) model from the CBCT images; determining a location of the navigation catheter in the CBCT images; generating a pathway from the determined location of the navigation catheter through the 3D model to the location of the target; and determine whether a subsequent intraprocedural CBCT scan is recommended; and if it is determined that the subsequent intraprocedural CBCT scan is recommended, output a signal for display in a user interface that the subsequent intraprocedural CBCT scan is recommended.

2. The system of claim 1, wherein the subsequent intraprocedural CBCT scan is recommended when a time since the initial intraprocedural CBCT scan exceeds a threshold.

3. The system of any of the preceding claims, wherein the navigation catheter includes a location sensor operable to output a signal indicative of a location within the luminal network.

4. The system of any of the preceding claims, wherein the subsequent intraprocedural CBCT scan is recommended when the navigation catheter is within a threshold distance of the target.

5. The system of claims 3 or 4, wherein the sensor is an electromagnetic (EM) sensor configured to detect an EM field generated around the patient.

6. The system of claims 3 or 4 wherein the sensor is a fiber-bragg shape sensor.

7. The system of any of the preceding claims, wherein the navigation catheter includes a force sensor configured to detect a force applied to the navigation catheter.

8. The system of claim 7, wherein the subsequent intraprocedural CBCT scan is recommended when the force applied to the navigation catheter exceeds a threshold.

9. The system of claims 7 or 8 wherein the subsequent intraprocedural CBCT scan is recommended when the force applied to the navigation catheter does not equate to a change in location of the location sensor.

10. The system of any of the preceding claims, wherein the memory stores instructions that when executed by the processor perform a step of receiving a subsequent intraprocedural CBCT scan.

11. The system of claim 10, wherein the subsequent intraprocedural CBCT scan is registered to the initial intraprocedural CBCT scan.

12. The system of any of the preceding claims, wherein the navigation catheter is motorized.

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

14. A method of navigating a navigational catheter within a luminal network comprising: advancing a navigational catheter to a first location within a luminal network; acquiring an initial intraprocedural cone-beam computed tomography (CBCT) scan includes a plurality of CBCT images; identifying a location of a target in the CBCT images; generating a three-dimensional (3D) model from the CBCT images; determining a location of the navigation catheter in the CBCT images; generating a pathway from the determined location of the navigation catheter through the 3D model to the location of the target; and determining whether a subsequent intraprocedural CBCT scan is recommended; and if it is determined that the subsequent intraprocedural CBCT scan is recommended, output a signal for display in a user interface that the subsequent intraprocedural CBCT scan is recommended.

15. The method of claim 14, wherein the subsequent intraprocedural CBCT scan is recommended when a time since the initial intraprocedural CBCT scan exceeds a threshold.

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