Method of using lung airway carina locations to improve ENB registration

Disclosed are systems, devices, and methods for registering a luminal network to a 3D model of the luminal network. An example method comprises generating a 3D model of a luminal network, identifying a target within the 3D model, determining locations of a plurality of carinas in the luminal network proximate the target, displaying guidance for navigating a location sensor within the luminal network, tracking the location of the location sensor, comparing the tracked locations of the location sensor and the portions of the 3D model representative of open space, displaying guidance for navigating the location sensor a predetermined distance into each lumen originating at the plurality of carinas proximate the target, tracking the location of the location sensor while the location sensor is navigated into each lumen, and updating the registration of the 3D model with the luminal network based on the tracked locations of the location sensor.

BACKGROUND

Technical Field

The present disclosure relates to bronchial registration and, more particularly, to devices, systems, and methods for automatically registering a three-dimensional bronchial tree model with a patient's real bronchial tree.

Description of Related Art

A common device for inspecting the airway of a patient is a bronchoscope. Typically, the bronchoscope is inserted into a patient's airways through the patient's nose or mouth and can extend into the lungs of the patient. A typical bronchoscope includes an elongated flexible tube having an illumination assembly for illuminating the region distal to the bronchoscope's tip, an imaging assembly for providing a video image from the bronchoscope's tip, and a working channel through which instruments, e.g., diagnostic instruments such as biopsy tools, therapeutic instruments can be inserted.

Bronchoscopes, however, are limited in how far they may be advanced through the airways due to their size. Where the bronchoscope is too large to reach a target location deep in the lungs, a clinician may utilize certain real-time imaging modalities such as fluoroscopy. Fluoroscopic images, while useful, present certain drawbacks for navigation as it is often difficult to distinguish luminal passageways from solid tissue. Moreover, the images generated by the fluoroscope are two-dimensional whereas navigating the airways of a patient requires the ability to maneuver in three dimensions.

To address these issues, systems have been developed that enable the development of three-dimensional models of the airways or other luminal networks, typically from a series of computed tomography (CT) images. One such system has been developed as part of the ILOGIC® ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY® (ENB™), system currently sold by Medtronic PLC. The details of such a system are described in commonly assigned U.S. Pat. No. 7,233,820, entitled ENDOSCOPE STRUCTURES AND TECHNIQUES FOR NAVIGATING TO A TARGET IN BRANCHED STRUCTURE, filed on Mar. 29, 2004, by Gilboa, the entire contents of which are incorporated herein by reference.

While the system as described in U.S. Pat. No. 7,233,820 is quite capable, there is always a need for development of improvements and additions to such systems.

SUMMARY

Provided in accordance with the present disclosure is a method of using carina locations to improve registration of a luminal network to a 3D model of the luminal network.

In an aspect of the present disclosure, the method includes generating a 3D model of a luminal network based on images of the luminal network, identifying a target within the 3D model of the luminal network, determining locations of a plurality of carinas in the luminal network proximate the target, displaying guidance for navigating a location sensor within the luminal network, tracking the location of the location sensor while the location sensor is navigated within the luminal network, comparing the tracked locations of the location sensor within the luminal network and the portions of the 3D model representative of open space, displaying guidance for navigating the location sensor a predetermined distance into each lumen originating at the plurality of carinas proximate the target, tracking the location of the location sensor while the location sensor is navigated the predetermined distance into each lumen, and updating the registration of the 3D model with the luminal network based on the tracked locations of the location sensor as it is navigated past the plurality of carinas proximate the target.

In a further aspect of the present disclosure, the luminal network is an airway of a patient.

In yet a further aspect of the present disclosure, the 3D model is a model of the airway of the patient.

In another aspect of the present disclosure, the carinas are used as fiducial markers for identifying the location of the target.

Provided in accordance with the present disclosure is a system of using carina locations to improve registration of a luminal network to a 3D model of the luminal network.

In an aspect of the present disclosure, the comprises a location sensor capable of being navigated within a luminal network inside a patient's body, an electromagnetic field generator configured to detect the location of the location sensor as it is navigated within the luminal network, and a computing device including a processor and a memory storing instructions which, when executed by the processor, cause the computing device to generate a 3D model of the luminal network based on images of the luminal network, identify a target within the 3D model of the luminal network, determine locations of a plurality of carinas in the luminal network proximate the target, display guidance for navigating the location sensor within the luminal network, track the location of the location sensor while the location sensor is navigated within the luminal network, compare the tracked locations of the location sensor within the luminal network and the portions of the 3D model representative of open space, display guidance for navigating the location sensor a predetermined distance into each lumen originating at the plurality of carinas proximate the target, track the location of the location sensor while the location sensor is navigated the predetermined distance into each lumen, and update the registration of the 3D model with the luminal network based on the tracked locations of the location sensor as it is navigated past the plurality of carinas proximate the target.

In a further aspect of the present disclosure, the luminal network is an airway of a patient.

In yet a further aspect of the present disclosure, the 3D model is a model of the airway of the patient.

In another aspect of the present disclosure, the carinas are used as fiducial markers for identifying the location of the target.

Provided in accordance with the present disclosure is a computer-readable storing medium storing instructions which, when executed by a processor, cause a computing device to use carina locations to improve registration of a luminal network to a 3D model of the luminal network.

In an aspect of the present disclosure, the non-transitory computer-readable storing medium stores instructions which, when executed by a processor, cause a computing device to generate a 3D model of a luminal network based on images of the luminal network, identify a target within the 3D model of the luminal network, determine locations of a plurality of carinas in the luminal network proximate the target, display guidance for navigating a location sensor within the luminal network, track the location of the location sensor while the location sensor is navigated within the luminal network, compare the tracked locations of the location sensor within the luminal network and the portions of the 3D model representative of open space, display guidance for navigating the location sensor a predetermined distance into each lumen originating at the plurality of carinas proximate the target, track the location of the location sensor while the location sensor is navigated the predetermined distance into each lumen, and update the registration of the 3D model with the luminal network based on the tracked locations of the location sensor as it is navigated past the plurality of carinas proximate the target.

In a further aspect of the present disclosure, the luminal network is an airway of a patient.

In yet a further aspect of the present disclosure, the 3D model is a model of the airway of the patient.

In another aspect of the present disclosure, the carinas are used as fiducial markers for identifying the location of the target.

Any of the above aspects and embodiments of the present disclosure may be combined without departing from the scope of the present disclosure.

DETAILED DESCRIPTION

The present disclosure is directed to devices, systems, and methods for registering a three-dimensional bronchial tree model (hereinafter referred to as a “3D model”) with a patient's airways. Various methods for generating the 3D model and identifying target lesions are envisioned, some of which are more fully described in co-pending U.S. Patent Application Publication Nos. US 2014/0281961, US 2014/0270441, and US 2014/0282216, all entitled PATHWAY PLANNING SYSTEM AND METHOD, filed on Mar. 15, 2013, by Baker, the entire contents of all of which are incorporated herein by reference. Following generation of the 3D model and identification of the target lesions, the 3D model must be registered with the patient's airways. Various methods of manual and automatic registration are envisioned, some of which are more fully described in co-pending U.S. patent application Ser. No. 14/790,581, entitled REAL TIME AUTOMATIC REGISTRATION FEEDBACK, filed on Jul. 2, 2015, by Brown et al., the entire contents of which is incorporated herein by reference. As is described in more detail below, to further improve registration accuracy between the 3D model and the patient's airways, the clinician may, following automatic registration, perform additional localized registration of the airways surrounding the identified target lesions.

The registration system of the present disclosure, for example, generally includes at least one sensor whose position is tracked within an electromagnetic field. The location sensor may be incorporated into different types of tools, and enables determination of the current location of the tools within a patient's airways by comparing the sensed location in space to locations within the 3D model. The registration facilitates navigation of the sensor or a tool to a target location and/or manipulation of the sensor or tool relative to the target location. Navigation of the sensor or tool to the target location is more fully described in co-pending U.S. patent application Ser. No. 14/753,288, entitled SYSTEM AND METHOD FOR NAVIGATING WITHIN THE LUNG, filed on Jun. 29, 2015, by Brown et al., the entire contents of which is incorporated herein by reference.

Additional features of the ENB system of the present disclosure are described in co-pending U.S. patent application Ser. No. 14/753,229, entitled METHODS FOR MARKING BIOPSY LOCATION, filed on Jun. 29, 2015, by Brown; Ser. No. 14/754,058, entitled INTELLIGENT DISPLAY, filed on Jun. 29, 2015, by Kehat et al.; Ser. No. 14/788,952, entitled UNIFIED COORDINATE SYSTEM FOR MULTIPLE CT SCANS OF PATIENT LUNGS, filed on Jul. 1, 2015, by Greenburg; Ser. No. 14/790,395, entitled ALIGNMENT CT, filed on Jul. 2, 2015, by Klein et al.; Ser. No. 14/725,300, entitled FLUOROSCOPIC POSE ESTIMATION, filed on May 29, 2015, by Merlet; Ser. No. 14/753,674, entitled TRACHEA MARKING, filed on Jun. 29, 2015, by Lachmanovich et al.; Ser. Nos. 14/755,708 and 14/755,721, both entitled SYSTEM AND METHOD FOR DETECTING TRACHEA, filed on Jun. 30, 2015, by Markov et al.; Ser. No. 14/754,867, entitled SYSTEM AND METHOD FOR SEGMENTATION OF LUNG, filed on Jun. 30, 2015, by Markov et al.; Ser. No. 14/790,107, entitled SYSTEM AND METHOD FOR PROVIDING DISTANCE AND ORIENTATION FEEDBACK WHILE NAVIGATING IN 3D, filed on Jul. 2, 2015, by Lachmanovich et al.; and Ser. No. 14/751,257, entitled DYNAMIC 3D LUNG MAP VIEW FOR TOOL NAVIGATION INSIDE THE LUNG, filed on Jun. 26, 2015, by Weingarten et al., the entire contents of all of which are incorporated herein by reference.

Detailed embodiments of such devices, systems incorporating such devices, and methods using the same are described below. However, these detailed embodiments are merely examples of the disclosure, which may be embodied in various forms. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting but merely as a basis for the claims and as a representative basis for allowing one skilled in the art to variously employ the present disclosure in virtually any appropriately detailed structure. While the example embodiments described below are directed to the bronchoscopy of a patient's airways, those skilled in the art will realize that the same or similar devices, systems, and methods may also be used in other lumen networks, such as, for example, the vascular, lymphatic, and/or gastrointestinal networks.

With reference toFIG. 1, an electromagnetic navigation (EMN) system10is provided in accordance with the present disclosure. One such EMN system is the ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY® system currently sold by Medtronic PLC. Among other tasks that may be performed using the EMN system10are planning a pathway to target tissue, navigating a positioning assembly to the target tissue, navigating a biopsy tool to the target tissue to obtain a tissue sample from the target tissue using the biopsy tool, digitally marking the location where the tissue sample was obtained, and placing one or more echogenic markers at or around the target.

EMN system10generally includes an operating table40configured to support a patient; a bronchoscope50configured for insertion through the patient's mouth and/or nose into the patient's airways; monitoring equipment60coupled to bronchoscope50for displaying video images received from bronchoscope50; a tracking system70including a tracking module72, a plurality of reference sensors74, and an electromagnetic (EM) field generator76; a workstation80including software and/or hardware used to facilitate pathway planning, identification of target tissue, navigation to target tissue, and digitally marking the biopsy location

FIG. 1also depicts two types of catheter guide assemblies90,100. Both catheter guide assemblies90,100are usable with EMN system10and share a number of common components. Each catheter guide assembly90,100includes a handle91, which is connected to an extended working channel (EWC)96. EWC96is sized for placement into the working channel of a bronchoscope50. In operation, a locatable guide (LG)92, including an EM sensor94, is inserted into EWC96and locked into position such that sensor94extends a desired distance beyond a distal tip93of EWC96. The location of EM sensor94, and thus the distal end of EWC96, within an EM field generated by EM field generator76can be derived by tracking module72, and workstation80. Catheter guide assemblies90,100have different operating mechanisms, but each contain a handle91that can be manipulated by rotation and compression to steer distal tip93of LG92and EWC96. Catheter guide assemblies90are currently marketed and sold by Medtronic PLC under the name SUPERDIMENSION® Procedure Kits. Similarly, catheter guide assemblies100are currently sold by Medtronic PLC under the name EDGE™ Procedure Kits. Both kits include a handle91, EWC96, and LG92. For a more detailed description of the catheter guide assemblies90,100, reference is made to commonly-owned U.S. Patent Publication Serial No. US 2014/0046315, entitled MICROWAVE ABLATION CATHETER AND METHOD OF UTILIZING THE SAME, filed on Mar. 15, 2013, by Ladtkow et al., the entire contents of which are hereby incorporated by reference.

As illustrated inFIG. 1, the patient is shown lying on operating table40with bronchoscope50inserted through the patient's mouth and into the patient's airways. Bronchoscope50includes a source of illumination and a video imaging system (not explicitly shown) and is coupled to monitoring equipment60, e.g., a video display, for displaying the video images received from the video imaging system of bronchoscope50.

Catheter guide assemblies90,100including LG92and EWC96are configured for insertion through a working channel of bronchoscope50into the patient's airways (although the catheter guide assemblies90,100may alternatively be used without bronchoscope50). LG92and EWC96are selectively lockable relative to one another via a locking mechanism99. A six degrees-of-freedom electromagnetic tracking system70, e.g., similar to those disclosed in U.S. Pat. No. 6,188,355 and published PCT Application Nos. WO 00/10456 and WO 01/67035, the entire contents of each of which is incorporated herein by reference, or any other suitable positioning measuring system, is utilized for performing navigation, although other configurations are also contemplated. Tracking system70is configured for use with catheter guide assemblies90,100to track the position of EM sensor94as it moves in conjunction with EWC96through the airways of the patient, as detailed below.

As shown inFIG. 1, electromagnetic field generator76is positioned beneath the patient. Electromagnetic field generator76and the plurality of reference sensors74are interconnected with tracking module72, which derives the location of each reference sensor74in six degrees of freedom. One or more of reference sensors74are attached to the chest of the patient. The six degrees of freedom coordinates of reference sensors74are sent to workstation80, which includes and application81which uses data collected by sensors74to calculate a patient coordinate frame of reference.

Also shown inFIG. 1is a catheter biopsy tool102that is insertable into catheter guide assemblies90,100following navigation to a target and removal of LG92. Biopsy tool102is used to collect one or more tissue samples from the target tissue. As detailed below, biopsy tool102is further configured for use in conjunction with tracking system70to facilitate navigation of biopsy tool102to the target tissue, tracking of a location of biopsy tool102as it is manipulated relative to the target tissue to obtain the tissue sample, and/or marking the location where the tissue sample was obtained.

Although navigation is detailed above with respect to EM sensor94being included in LG92it is also envisioned that EM sensor94may be embedded or incorporated within biopsy tool102where biopsy tool102may alternatively be utilized for navigation without need of LG92or the necessary tool exchanges that use of LG92requires. A variety of useable biopsy tools are described in U.S. Provisional Patent Application No. 61/906,732, entitled DEVICES, SYSTEMS, AND METHODS FOR NAVIGATING A BIOPSY TOOL TO A TARGET LOCATION AND OBTAINING A TISSUE SAMPLE USING THE SAME, filed Nov. 20, 2013, U.S. patent application Ser. No. 14/488,754, entitled DEVICES, SYSTEMS, AND METHODS FOR NAVIGATING A BIOPSY TOOL TO A TARGET LOCATION AND OBTAINING A TISSUE SAMPLE USING THE SAME, filed Sep. 17, 2014, and U.S. patent application Ser. No. 14/564,779, entitled DEVICES, SYSTEMS, AND METHODS FOR NAVIGATING A BIOPSY TOOL TO A TARGET LOCATION AND OBTAINING A TISSUE SAMPLE USING THE SAME, filed on Dec. 9, 2014, the entire contents of each of which is incorporated herein by reference and useable with EMN system10as described herein.

During procedure planning, workstation80utilizes computed tomographic (CT) image data for generating and viewing the 3D model of the patient's airways, enables the identification of target tissue on the 3D model (automatically, semi-automatically or manually), and allows for the selection of a pathway through the patient's airways to the target tissue. More specifically, the CT scans are processed and assembled into a 3D volume, which is then utilized to generate the 3D model of the patient's airways. The 3D model may be presented on a display monitor associated with workstation80, or in any other suitable fashion. Using workstation80, various slices of the 3D volume and views of the 3D model may be presented and/or may be manipulated by a clinician to facilitate identification of a target and selection of a suitable pathway through the patient's airways to access the target. The 3D model may also show marks of the locations where previous biopsies were performed, including the dates, times, and other identifying information regarding the tissue samples obtained. These marks may also be selected as the target to which a pathway can be planned. Once selected, the pathway is saved for use during the navigation procedure. An example of a suitable pathway planning system and method is described in U.S. Patent Application Publication Nos. US 2014/0281961, US 2014/0270441, and US 2014/0282216, all entitled PATHWAY PLANNING SYSTEM AND METHOD, filed on Mar. 15, 2013, by Baker, the entire contents of each of which is incorporated herein by reference.

During navigation, EM sensor94, in conjunction with tracking system70, enables tracking of EM sensor94and/or biopsy tool102as EM sensor94or biopsy tool102is advanced through the patient's airways.

Turning now toFIG. 2, there is shown a system diagram of workstation80. Workstation80may include memory202, processor204, display206, network interface208, input device210, and/or output module212.

Memory202includes any non-transitory computer-readable storage media for storing data and/or software that is executable by processor204and which controls the operation of workstation80. In an embodiment, memory202may include one or more solid-state storage devices such as flash memory chips. Alternatively or in addition to the one or more solid-state storage devices, memory202may include one or more mass storage devices connected to the processor204through a mass storage controller (not shown) and a communications bus (not shown). Although the description of computer-readable media contained herein refers to a 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 processor204. That is, computer readable storage media includes non-transitory, volatile and non-volatile, removable and non-removable 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 includes 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 can be used to store the desired information and which can be accessed by workstation80.

Memory202may store application81and/or CT data214. Application81may, when executed by processor204, cause display206to present user interface216. Network interface208may 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. Input device210may be any device by means of which a user may interact with workstation80, such as, for example, a mouse, keyboard, foot pedal, touch screen, and/or voice interface. Output module212may 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.

Referring now toFIG. 3, there is shown a flowchart of an example method for registering the 3D model with a patient's airways. As described above, at step302, the 3D model is generated prior to the start of the registration process, and, at step304, the clinician generates a navigation plan based on the 3D model, the navigation plan including one or more targets. Thereafter, the clinician loads the navigation plan into application81from memory202, a USB device, or from network interface208. The navigation plan may require that all or only some regions of the patient's lungs be registered.

At step306, application81displays guidance for performing automatic registration of the 3D model with the patient's airways, as described above, and in particular as described in co-pending U.S. patent application Ser. No. 14/790,581, entitled REAL TIME AUTOMATIC REGISTRATION FEEDBACK, filed on Jul. 2, 2015, by Brown et al., the entire contents of which is incorporated herein by reference. During registration, the location of EM sensor94within the patient's airways is tracked, and a plurality of points denoting the location of EM sensor94within the EM field generated by EM generator76is stored. At step308, application81determines whether automatic registration has been completed. If no, processing returns to step306, where further guidance is displayed to complete the automatic registration process. If yes, processing proceeds to step310.

At step310, application81begins the localized registration process by displaying guidance for navigating EM sensor94proximate a target404. Thereafter, at step312, application81determines one or more carina locations proximate the target. Application81determines the carina locations by analyzing the area of the 3D model proximate the target and any bifurcations in the airways. As shown inFIG. 4, a view400of the 3D model includes an airway tree402, target404, one or more carina406, and airway branches408originating from the bifurcations at the carina406. For example, application81may identify a plurality of carinas406approximately evenly spaced in the vicinity of target404. In embodiments, the carinas may be detected visually by the clinician by viewing a live video feed from a camera located proximate EM sensor94, for example, in LG92or EWC96. The clinician may match the visually detected carinas with airways depicted on the 3D model.

At step314, application81displays guidance for navigating EM sensor94into each airway branch408originating from a bifurcation at a carina406. The clinician follows the displayed guidance to navigate EM sensor94in the patient's airways. For example, the guidance may instruct the clinician to navigate EM sensor94approximately 1 cm into each airway branch408. Application81tracks the location of EM sensor94at step316as EM sensor94is navigated into the airway branches408originating from carina406and stores a plurality of points denoting the location of EM sensor94within the EM field generated by EM generator76. Application81uses the stored points denoting the location of EM sensor94to, at step318, perform localized registration of the 3D model with the patient's airways proximate the target. For example, localized registration may be performed based on a range of interpolation techniques, such as Thin Plates Splines (TPS) interpolation. In embodiments, TPS interpolation may be used for non-rigid registration of the points denoting the location of EM sensor94within the EM field generated by EM generator76stored during automatic registration with the 3D model, and may be augmented by additional points stored during localized registration.

Thereafter, at step320, application81determines whether localized registration has been completed for the current target. If no, processing returns to step314where further guidance is displayed. If yes, processing proceeds to step322where application81determines if there are any more targets remaining in the navigation plan for which localized registration has not been performed. If yes, processing returns to step310, where application81displays guidance for navigating EM sensor94proximate the next target. If no, the localized registration process is complete, and processing ends.

In addition to using carinas406for localized registration, carinas406may also be used as fiducial markers for locating target404. Carinas406are particularly useful as fiducial markers because, unlike implanted foreign body markers, carinas406cannot migrate.