Rerouting in Pulmonary-Related Interventions

Abstract

An apparatus for rerouting a planned path for an interventional device is provided. A data input unit provides a current position of the interventional device relative to a preoperative 3D model. A data storage unit provides a preoperative 3D model of a portion of a target airway, and provides 3D models of available interventional devices and physical parameters associated with the available interventional devices. Upon receiving a trigger signal, a data processor calculates multiple candidate paths from the current location to a target location taking into account the 3D models and associated physical parameters of the available interventional devices, simulates the multiple candidate paths, determines device-path compatibility of the simulated candidate paths, and evaluates the simulated candidate path for selection of a candidate. An output interface provides the simulated candidate path for further navigation of the interventional device.

Description

[Technical Field]

[0001] The present invention relates to routing in pulmonary related interventions, and in particular to an apparatus for rerouting a planned path for an interventional device in a pulmonary related intervention, a system for pulmonary related navigation guidance, and a method for rerouting a planned path for an interventional device in a pulmonary related intervention. [Background technology]

[0002] As an example related to pulmonary bronchoscopy, peripheral pulmonary nodules are widely considered difficult to obtain through transbronchial biopsy (TBB) and transbronchial needle aspiration (TBNA) due to the difficulty of navigating catheters and biopsy devices through the narrow and complex peripheral airways. One example of navigation support is CT-guided percutaneous procedures. For example, they can demonstrate high diagnostic yields, approximately 90%. Another example is transbronchial methods, which have a greater safety margin for patients, especially in reducing the risk of dangerous complications such as pneumothorax and bleeding. One of the major obstacles to increasing the diagnostic yield in peripheral TBNA may be the difficult navigation setting. However, while modern navigation technologies such as endobronchial ultrasound (EBUS), radial endobronchial ultrasound (r-EBUS), and electromagnetic navigation (EMN) have made transbronchial biopsy and needle aspiration more attractive propositions, their successful use remains low in peripheral lesions compared to other targets and transthoracic methods. Summary of the Invention [Problem to be solved by the invention]

[0003] Therefore, there may be a need to provide further and improved guidance in lung-related interventions. [Means for solving the problem]

[0004] The object of the present invention is solved by the subject matter of the independent claims, further embodiments are incorporated in the dependent claims. It is noted that the below-described aspects of the present invention also apply to an apparatus for rerouting a planned path for an interventional device in a pulmonary-related intervention, a system for pulmonary-related navigation guidance and a method for rerouting a planned path for an interventional device in a pulmonary-related intervention.

[0005] According to the present invention, there is provided an apparatus for rerouting a planned path for an interventional device in a pulmonary-related intervention. The apparatus includes a data input unit, a data storage device, a data processor, and an output interface. The data storage device is configured to provide a preoperative 3D model of at least a portion of a subject's airway currently undergoing a pulmonary-related procedure. The data storage device is also configured to provide at least one 3D model of at least one available interventional device and physical parameters associated with the at least one available interventional device. The data input unit is configured to provide a current position of the interventional device relative to the preoperative 3D model. Upon receiving a trigger signal for rerouting during a pulmonary-related navigation procedure having a preoperatively planned path to a legal location, the data processor is configured to calculate multiple candidate paths from the current location to a target location, taking into account the at least one 3D model and the associated physical parameters of the at least one available interventional device. For calculating the candidate paths, the data processor is configured to simulate the multiple candidate paths. Furthermore, for simulating, the data processor is configured to determine device-route compatibility of the simulated candidate paths and evaluate the simulated candidate paths for selection of at least one candidate path. The output interface is configured to provide at least one simulated path candidate for further navigation of the interventional device.

[0006] In effect, the accessibility of peripheral lesions by particular devices maneuvered through the peripheral airways is determined.

[0007] To navigate to the approach or target, the device geometry is taken into account. The suitability of different guide sheaths for the purpose of pulmonary bronchoscopy and their limitations regarding the delivery angles of both the sheath and the needle are simulated.

[0008] According to one example, the physical parameters include at least one of the group of flexibility of the device, change in flexibility along the length of the device, bend radius of the device, change in bend radius along the length of the device, surface smoothness of the device and resulting friction with adjacent or neighboring tissue surfaces, and size of the device.

[0009] This provides the advantage that routing to the target can be better adapted to the respective device used to navigate through the airway structure.

[0010] According to one example, at least one parameter of the group of interventional device type, interventional device flexibility, interventional device radius, imaging device type, device tip size, needle or forceps size, and navigation path is changed to simulate.

[0011] For example, by comparing two different example needle delivery devices with various delivery angles and several sheath / needle combinations, optimized rerouting is provided.

[0012] Varying the delivery angle also improves the success rate of reaching the target biopsy site depending on lesion size, needle size, and type of guide sheath, indicating that the choice of route and delivered device are mutually constraining.

[0013] According to one example, the data input is configured to receive a user interaction to identify a location of an obstruction in the subject's airway, and the data processor is configured to take the obstruction into account when simulating the potential paths.

[0014] As an advantage, the user can add navigation related information that is used in the routing calculations.

[0015] According to one example, possible simulated route candidates are provided to the user for user selection.

[0016] The user can select the appropriate route.

[0017] According to one example, for the evaluation, at least one of the following criteria is measured: amount of target tissue that can be biopsied, avoidance of critical surroundings including at least one of important vasculature and important nerve tract groups, path navigability, and fluoroscopic view quality.

[0018] This allows identifying the suitability of the pathway under each aspect.

[0019] According to one example, the data processor is configured to numerically evaluate the measured criteria, select the simulated path with the highest score, and propose the path as a rerouted path for updated navigation to the target location.

[0020] Such evaluations provide an attempt to provide an objective selection process for the user, thus further facilitating the user's workflow.

[0021] According to one example, a plurality of 3D models of a set of available equipment in an operating room are provided, and for the simulation, the data processor is configured to base a variation of at least one parameter on the set of available equipment.

[0022] This allows the usefulness of other available devices to be identified, further improving the navigation procedure.

[0023] According to one example, the data processor is configured to generate and present to the user a simulated perspective view of the target region for a given approach angle for each simulated path.

[0024] The simulated views provide a familiar source of information to the user due to their similar appearance to fluoroscopic images.

[0025] According to the present invention, a system for pulmonary-related navigation guidance is provided. The system includes an apparatus for rerouting a planned path for an interventional device in a pulmonary-related intervention according to one of the examples described above. The system also includes an interventional device positioning arrangement. The system further includes a user interaction interface and a display arrangement. The user interaction interface is configured to generate a trigger signal for rerouting during the pulmonary-related navigation procedure. The interventional device positioning arrangement is configured to determine a current position of the interventional device when the trigger signal is generated. The apparatus for rerouting the planned path provides at least one simulated path that serves as navigation for continuing to move the interventional device toward the target, and the display arrangement is configured to provide the at least one simulated path.

[0026] According to the present invention, a method for rerouting a planned path for an interventional device in a lung-related intervention is provided. The method includes the steps of: providing a preoperative 3D model of at least a portion of the airway of a subject currently undergoing a lung-related procedure; and providing at least one 3D model of at least one available interventional device and physical parameters associated with the at least one available interventional device. Upon receiving a trigger signal for rerouting during a lung-related navigation procedure having a preoperatively planned path to a target location, the method: providing a current position of the interventional device relative to the preoperative 3D model; and calculating multiple candidate paths from the current position to the target location, taking into account the at least one 3D model and associated physical parameters of the at least one available interventional device. For the calculation of the candidate paths, simulating the multiple candidate paths is provided. Furthermore, the simulating step includes determining device-path compatibility of the simulated candidate paths and evaluating the simulated candidate paths to select the best candidate.

[0027] Device combinations may also constrain one another. For example, a guide sheath optimally positioned near the lesion to be biopsied may be straightened when the needle is inserted through it, potentially making the device combination less than optimally positioned for biopsy. Each factor may also have trade-offs; for example, reducing the needle size improves maneuverability and increases the range of successful delivery angles, but reduces the size of the biopsy tissue sample as well as reach outside the airway for transbronchial biopsy.

[0028] In addition to device selection and pathway kinks, patient safety is also a concern. Proximity of the navigation pathway or needle delivery site to major blood vessels or other critical structures is believed to avoid negative outcomes.

[0029] As an example, the present invention is intended for peripheral pulmonary bronchoscopy path planning and rerouting; however, similar methods can be applied to vascular navigation and rerouting, as well as navigation of any endoscopic device through anatomy where several paths are possible.

[0030] The present invention provides detours in a time-saving manner, increasing the likelihood that the user's task will ultimately be successful. By considering the local geometry of the airway relative to the size and shape of the biopsy device, and also addressing imaging conditions relative to its approach angle, the consequences of sampling tissue far from the preferred target location or a failed biopsy are avoided, and therefore entirely prevented. Particularly for transbronchial lesions, i.e., lesions located outside the airway itself, several routes may exist to reach the same target location, varying in which distal branch is accessed and where the airway wall is punctured to reach the target location. The accessibility of each option may not be apparent until the time of the procedure. The present invention allows the user to optimize the routing procedure during actual device movement.

[0031] These and other aspects of the invention will be apparent from and elucidated with reference to the embodiments described hereinafter.

[0032] Exemplary embodiments of the present invention are described below with reference to the following drawings: [Brief explanation of the drawings]

[0033] [Figure 1] 1 illustrates schematically an example of an apparatus for rerouting a planned path for an interventional device in a pulmonary-related intervention. [Figure 2] 1 illustrates an example system for lung-related navigation guidance. [Figure 3a] 10 shows an example of how sample path / device selections are presented to the user after a simulation. [Figure 3b]10 shows an example of how sample path / device selections are presented to the user after a simulation. [Figure 4] 1 illustrates the basic steps of an example method for rerouting a planned path for an interventional device in a pulmonary-related intervention. DETAILED DESCRIPTION OF THE INVENTION

[0034] Specific embodiments will now be described in detail with reference to the accompanying drawings. In the following description, like drawing reference numbers are used for like elements, even in different drawings. Matters defined herein, such as detailed configurations and elements, are provided to facilitate a comprehensive understanding of the exemplary embodiments. Additionally, well-known functions or configurations will not be described in detail since they would obscure the embodiments in unnecessary detail. Furthermore, phrases such as "at least one of," when preceding a list of elements, modify the entire list of elements, and not individual elements of the list.

[0035] FIG. 1 schematically illustrates an example of an apparatus 10 for rerouting a planned path for an interventional device in a pulmonary-related intervention. The apparatus 10 includes a data input unit 12, a data storage device 14, a data processor 16, and an output interface 18. The data input unit 12 is configured to provide a current position of the interventional device relative to a preoperative 3D model. The data storage device 14 is configured to provide a preoperative 3D model of at least a portion of the airway of a subject currently undergoing a pulmonary-related procedure. The data storage device 14 is also configured to provide at least one 3D model of at least one available interventional device and physical parameters associated with the at least one available interventional device. Upon receiving a trigger signal for rerouting during a pulmonary-related navigation procedure having a preoperatively planned path to a target location, the data processor 16 is configured to calculate multiple candidate paths from the current location to the target location, taking into account the at least one 3D model and associated physical parameters of the at least one available interventional device. For the calculation of the candidate paths, the data processor 16 is configured to simulate the multiple candidate paths. Further, for the simulation, the data processor 16 is configured to determine device-path compatibility of the simulated path candidates and evaluate the simulated path candidates for selection of at least one candidate. The output interface 18 is configured to provide at least one simulated path candidate for further navigation of the interventional device.

[0036] A first dashed arrow 20 indicates data entry of, for example, the current position of the interventional device relative to the pre-operative 3D model.

[0037] A second dashed arrow 22 indicates a data output of at least one simulated path candidate for further navigation, for example of an interventional device.

[0038] The dashed frame 24 shows an exemplary display for presenting simulated route alternatives to a user, for example.

[0039] Frame 26 illustrates the option of providing data input 12, data storage device 14, data processor 16, and output interface 18 integrated together, such as in a common housing, however, they may be integrated in different combinations or even arranged as separate components.

[0040] In one example, the pre-operative 3D model includes at least a portion of the tree structure of the subject's airway.

[0041] The multiple candidate paths provide multiple routes, one of which is selected for navigation or maneuvering of an interventional device that is moved at least partially within the target airway structure.

[0042] Simulation is used to determine whether the currently selected route is compatible with the currently selected device and to evaluate the quality of the selection with respect to the above parameters. The simulation has two steps: 1) determining device / route compatibility, and 2) evaluating route quality.

[0043] The simulation is triggered by the physician during the surgical procedure when it is determined that the planned path has failed to reach the target site and a new path is required.

[0044] In a first step, the simulation determines, for the set of available devices in the operating room, whether their geometries are capable of physically reaching the target site via the selected path. By way of example, different ways to obtain this information are provided, e.g., system files, device recognition, etc.

[0045] In one example, a high-complexity device compatibility simulation involves physics-based modeling of the device traversing several candidate paths using a patient-specific airway model derived from preoperative imaging. Potential advantages can be provided if the manufactured device used has known physical characteristics, a CAD model is readily available, and is integrated into the operating and imaging system.

[0046] As an example, the coefficients involved in the route selection process are: -Device parameters, e.g. needle / catheter / imager size, shape, flexibility, - Route navigation possibilities, including airway diameter, angle of curvature, and tortuosity; -Device navigational feasibility at the distal end, e.g., the flexibility of the device may be known, but the user's ability to affect the distal end of the device by manipulating the proximal end may be limited based on its current configuration and anatomical location and therefore the needs of the simulation; -Biopsy site, e.g., needle approach angle, size / location of biopsy specimen, overlap with target lesion, -Safety factors, e.g., proximity to vessels / structures, and - viewing angle, e.g., the ability to see the target and its relationship to the device on its approach in the intraoperative modality from a given configuration; Includes:

[0047] In one example, the model performs a step-by-step comparison between the device and the route. The inputs to a simpler simulation are: 1. Device parameters D i ={d θ ,d r ,...}, where d θ indicates the bending limit of each segment of the device, and d r indicates the radius of the device along its length, etc., where "device" includes the guide catheter, imaging device, and biopsy device for each combination of device I, 2. airway parameter A j ={a θ ,a r ,...}, and aθ indicates the minimum bending angle required to pass through each segment of the airway, and a r denotes the radius of the airways over the path length for the set of candidate paths j, etc. Given these inputs, the simulator determines whether any physical constraints of the airways exceed the combined device limits for each set of device and airways.

[0048] The present invention addresses the dependency of some of the above factors on others, creating a high-dimensional problem that is solved on the fly by simulation provided as intraoperative rerouting that considers the possibility of optimizing multiple device options. While preoperative planning is based on preoperative knowledge, the rerouting of the present invention allows for the consideration of knowledge acquired during operation.

[0049] In one example, physics-based modeling based on devices with a priori known characteristics is provided.

[0050] The term "data input" relates to providing or supplying data for a data processing step. A data input may also be referred to as an image data input. A data input may also be referred to as a data supply, an image data supply, an image input, an input unit, or simply an input. In one example, the image data input is data connectable to an imaging source device.

[0051] The term "data processor" relates to a processor or part of a processor device provided for performing computational steps using data provided by a data input. A data processor may also be referred to as a data processing device, a processor unit or a processor. In one example, a data processor is data-connected to a data input and an output interface.

[0052] The term "output interface" relates to an interface for providing processed or calculated data for further purposes. The output interface can also be referred to as an output or an output unit. In one example, the output interface can be data-connected to a display arrangement or display device. In another example, the output is data-connected to a display. As an example, a signal by a controller can be provided by the output interface.

[0053] The term "current position" relates to the position of the device achieved during the actual guide movement. As an example, the current position refers to the leading (or distal) tip of the interventional device.

[0054] In one example, the interventional device is provided as a navigating catheter, as a biopsy device, or as an imaging device.

[0055] The term "candidate path" relates to a path, i.e., a route, identified by a data processor that is suitable for navigation to a target. The candidate path may be suitable for a currently provided interventional device. Optionally, the candidate path also relates to a path that is suitable for one or more other possibly available interventional devices.

[0056] The term "device-path compatibility" refers to the identified path, i.e., the general possible route, and its ability to suit a particular device. It is confirmed or verified that a particular interventional device can actually navigate through the identified path.

[0057] The term "evaluating" relates to determining or analyzing the suitability of a path compared to other paths. Evaluation can also be referred to as a rating or weighting based on the value of each path. Evaluation is provided to identify the most promising, or even the best, path. Evaluation may also have different value categories and provide a value to the user. For example, a particular path may be shorter than other paths, but it may be more difficult to maneuver the device along that path. Another example is a path that is less complex but results in a suboptimal angle for performing a biopsy operation.

[0058] Examples of pulmonary interventions are lung biopsy procedures and lung bronchoscopy procedures.

[0059] In one example not shown in further detail in FIG. 1 , the physical parameters include at least one of the group of flexibility of the device, change in flexibility along the length of the device, bend radius of the device, change in bend radius along the length of the device, surface smoothness of the device, and resulting friction with adjacent or adjacent tissue surfaces and size of the device.

[0060] In one example not shown in further detail in FIG. 1 , at least one parameter of the group of interventional device type, interventional device flexibility, interventional device radius, imaging device type, device tip size, needle or forceps size, and navigation path is varied for the simulation.

[0061] 1, data input 12 is configured to receive user interaction to identify the location of an obstruction in the subject's airway, and data processor 16 is configured to take the obstruction into account when simulating potential paths.

[0062] This allows the user to modify the information on which further route decisions are based. Optionally, the obstruction is transferred or input into a 3D model of the airway structure.

[0063] In one example, not shown in further detail in FIG. 1, possible simulated route candidates are provided to the user for user selection.

[0064] Finally, the set of top device / path candidates is shared with the physician for final review. Optionally, warnings or other signals are indicated if a device change is required for a particular path, for example, a smaller device with a higher chance of reaching the target, or if the currently delivered device is not compatible with all candidate paths, or if the quality scores of all paths for the current device are below a threshold. A simulated fluoroscopic view of the target site for a given approach angle is also displayed.

[0065] In one example, not shown in further detail in FIG. 1 , for evaluation, at least one of the following criteria is measured: amount of target tissue that can be biopsied, avoidance of critical surroundings with at least one of important vasculature and important nerve tract groups, pathway navigability, and fluoroscopic view quality.

[0066] The term "critical" refers to a blood vessel or nerve tract that, if affected during a biopsy or other interventional procedure, could result in serious injury or complications.

[0067] In a second step, the suitable routes are evaluated for quality and the best option is presented to the user. In one example, quality is determined by measuring: 1. The amount of target tissue that can be biopsied based on the needle approach angle and needle size: This can be calculated once the device reaches the target site by measuring the overlap between the simulated needle position when fully deployed and the segmented lesion from the pre-operative image. Quality can be calculated as a function of tissue volume or as a binary value indicating whether or not some threshold volume has been reached. 2. Ability to avoid critical vasculature: Quality can be calculated by measuring the minimum distance of the needle from any major blood vessel throughout the simulated procedure. 3. Path Navigability: The quality of path navigability can be measured by the maximum bending angle or maximum strain placed on the device during operation, as calculated by the above simulation. A path that is less tortuous is easier to traverse. 4. Fluoroscopy View Quality: The quality of the fluoroscopy view at the target site is valuable for the physician in confirming the success of the biopsy. This can be estimated by computing a digitally reconstructed radiograph through the preoperative computed tomography volume and varying the C-arm position until the view with the least obstruction is found (obstruction may include bony structures, etc.). In addition, views that are coplanar with the direction of device movement toward the target are optimal for assessing device penetration into the target. The degree of obstruction and device visibility for each approach angle serve as measures of view quality.

[0068] 1, data processor 16 is configured to numerically evaluate the measured criteria. Data processor 16 is also configured to select the simulated path with the highest score. Data processor 16 is further configured to suggest the path as a rerouted path for updated navigation to the target location.

[0069] In one example, data processor 16 is configured to provide a pre-operative 3D model of at least a portion of a lung of a subject currently undergoing a lung-related procedure and to segment airways from the pre-operative 3D model to provide a pre-operative 3D model of at least a portion of the tree structure. Data processor 16 is also configured to extract the tree structure of the airways.

[0070] In one example, instead of a pre-operative 3D model of the lung, a pre-operative 3D image is provided.

[0071] 1, multiple 3D models of the set of available equipment in an operating room are provided, and for the simulation, data processor 16 is configured to base the variation of at least one parameter on the set of available equipment.

[0072] In other words, for parameter variations, only those parameter combinations that are actually available in the operating room are applied.

[0073] Optionally, additional 3D models of a set of known devices are provided that are not currently available but can be located within a preset amount of time.

[0074] In one example not shown in further detail in Figure 1, data processor 16 is configured to provide a change indicator to the user when a simulated path based on one of the devices that is available but not currently being used is determined, the change indicator notifying the user that a device change is required to continue navigating the device toward the target along the simulated path.

[0075] In one example, data processor 16 is configured to determine a probability index for the simulated path and provide the probability index to a user, which may be useful, for example, when information about the actual airway structure and geometry is incomplete.

[0076] In one example, not shown in further detail in FIG. 1 , data processor 16 is configured to generate and present to the user simulated perspective views of the target region for a given approach angle for each simulated path.

[0077] In one example, not shown in further detail in FIG. 1, for the evaluation, the data processor 16 is configured to take into account the user's previous experience and expertise in order to recommend a combination of route and device.

[0078] In one example, - A preoperative 3D model of the lungs or anatomical structures of the individual patient to be operated on; this model can take the form of a point cloud, mesh, volumetric image (e.g., computed tomography), or other forms; - a set of 3D models of available interventional devices that may be used during the procedure; these devices may include, but are not limited to, catheters, guide sheaths, biopsy devices (needles, forceps, etc.), imaging devices (bronchoscopes, EBUS / r-EBUS probes, etc.); in addition, physical parameters associated with each device, such as the radius of the device as a function of its length, the maximum bending angle over that length, the maximum strain the device can undergo, etc.; - A preoperative image processing module segments the airways from preoperative images or models and extracts the airway tree structure (using centerlines or machine learning or other methods); a simulation module that initiates a simulation to determine the suitability of the device / path; the simulation varies all controllable parameters between possible devices and paths to determine which are physically feasible; this may consist of a physics-based simulation using the 3D model of the second element and the airway segmentation of the third element, which tests the traversal of the device through the airway and verifies whether there may be any insurmountable collisions or turns; a simulation module that evaluates all candidate device / pathway combinations from the fourth element above and generates measures that describe the quality of each option; A workflow and setup is provided having:

[0079] In another embodiment, a simulation is provided that compares the maximum bend angle and other constraints of the device with the required bend angle and other constraints of the airway for any mismatches.

[0080] In another embodiment, a neural network can be trained to assess the compatibility between device types and segmented airways.

[0081] Parameters to be changed may include catheter type / flexibility / radius, imaging device type and combination, needle / forceps size, and navigation path.

[0082] The measurements are derived from: -Biopsy quality: the amount of tissue overlap between the fully deployed needle and the target lesion, as determined by the position of the device relative to the target lesion in the simulation of the fourth factor above; -Safety measurements: needle distance from any critical anatomical structures throughout the procedure; - Path navigability measurement: the "difficulty" of traversing each of the selected paths, estimated by the amount of twisting of the path, or the maximum required bending angle or other parameters; and View Quality: The amount of anatomical obstruction of the C-arm view angle associated with a particular needle approach angle, as determined by simulation of the fourth element above. The C-arm view angle for each pathway / device combination may be the least obstructed view perpendicular to the needle travel direction, including the needle and the lesion. The view may be simulated from the preoperative CT image by generating a DRR. A processing controller that weights the quality measures of the fifth factor above and selects the best set of candidate route / device combinations for the user. A visualization module that displays candidate path / device combinations along with quality measurements and simulated fluoroscopic images from candidate view angles, alerting the user when a higher quality option exists that would require the deployed device to be changed, and allowing the user to decide whether the time spent changing the device is worth using an easier path.

[0083] Optionally, user interface elements are provided that initiate the simulation and visualization procedures of the fourth through seventh elements above.

[0084] In one example, personalized recommendations are made by further taking into account the user's prior experience and expertise. Certain routes and maneuvers that may be routine for experienced users may still present challenges to less experienced users. In addition, even experienced users may not be trained to use a particular device, such as an R-EBUS. In one example, the system records the user's ability to successfully navigate to and biopsy lesions using recommended route / device combinations over several procedures and / or over time, and adaptively learns to weight quality measures so that combinations that users typically perform well receive a higher weight than combinations that users find difficult.

[0085] According to one aspect, dynamic calculation of a path / device combination that optimizes path navigability, biopsy device approach angle, intraoperative imaging field of view, and patient safety is provided, such that this calculation can be performed intraoperatively to address the need for rapid and accurate rerouting and assessment of the need to switch devices if the original planned path fails to reach the target site.

[0086] According to one aspect, device selection is added to the framework, which is particularly advantageous when catheter / needle knowledge is provided that allows compatible device / pathway combinations to be more accurately modeled.

[0087] As an effect, bronchoscopy or lung biopsy procedure time is shortened if deviations from the original planned path must be made.

[0088] Optionally, automatic and dynamic route rerouting is provided in the event that the planned route fails.

[0089] As another option, device selection / change recommendations are provided if the currently deployed devices are not compatible with the newly calculated route.

[0090] As a further option, fluoroscopic view recommendations are provided for new pathway-anatomy configurations.

[0091] FIG. 2 illustrates an example of a system 50 for lung-related navigation guidance. The system 50 includes an example of the device 10 for rerouting a planned path for an interventional device in a lung-related intervention according to one of the aforementioned examples. Furthermore, an interventional device positioning device 52 is provided. Furthermore, the system 50 includes a user interaction interface 54 and a display device 56. The user interaction interface 54 is configured to generate a trigger signal for rerouting during a lung-related navigation procedure. The interventional device positioning device 52 is configured to determine a current position of the interventional device upon generation of the trigger signal. The device 10 for rerouting a planned path provides at least one simulated path that serves as navigation for continuing to move the interventional device toward the target. The display device 56 is configured to provide the at least one simulated path.

[0092] It should be noted that, for example, the connection lines between the interventional device positioning device 52 and the device 10 for rerouting a planned path for an interventional device in a pulmonary-related intervention, or the connection lines between the display device 56 and the device 10 for rerouting a planned path for an interventional device in a pulmonary-related intervention, or the connection lines between the device 10 for rerouting a planned path for an interventional device in a pulmonary-related intervention and the console 62, represent data connections that can be wired or wireless.

[0093] In one example, the interventional device position determining arrangement comprises at least one of the group of an X-ray imaging device, an electromagnetic sensor, and an ultrasound imaging device.

[0094] In Figure 2, a system 50 for lung-related navigational guidance is shown in relation to an interventional room in a medical facility, for example, a catheterization lab. Optionally, a subject support 58 is shown on which a subject 60, e.g., a patient, can be positioned. Optionally, a console 62 is shown in the right foreground. Also optionally, an imaging device 64 is shown. By way of example, the imaging device 64 comprises an X-ray imaging device having an X-ray source 66 and an X-ray detector 68 mounted on opposite ends of a movable C-arm 70.

[0095] Optionally, in the example shown in FIG. 2, an interventional device 72 is provided for movement along the internal airway structure towards the target.

[0096] In one example, a system is provided for optimizing navigation path and device selection based on the current state of the procedure to maximize path navigability, needle approach angle compatibility, target site visibility during imaging, and avoidance of critical vasculature.

[0097] The term "subject" may also be referred to as an individual. A "subject" may also be referred to as a patient, although it should be noted that this term does not indicate whether any disease or condition actually exists in the subject.

[0098] Figures 3a and 3b show an example of how a sample path / device selection is presented to the user after simulation. In Figures 3a and 3b, similar elements are designated with the same reference numerals, with an index ' being used in Figure 3b.

[0099] A simulated image 100 is shown with a complex airway structure 102. A device 104 is shown inserted along a path toward a target 106. The target lesion site is shown highlighted. A description and labeling of a particular catheter 110 is shown in the center portion. In FIG. 3a, the catheter 110 is labeled "Catheter A," and in FIG. 3b, the catheter 110' is labeled "Catheter B." Additionally, a description and labeling of a particular bronchoscope 112 is shown. In FIG. 3a, the bronchoscope is labeled "Bronchoscope A," and in FIG. 3b, the bronchoscope 112' is labeled "Bronchoscope B."

[0100] Additionally, the optimal digitally reconstructed radiograph (DRR) is shown at the bottom right of each option. In Figure 3a, the digitally reconstructed radiograph is designated by reference numeral 114, and in Figure 3b, the digitally reconstructed radiograph is designated by reference numeral 114'.

[0101] As a first option shown in Figure 3a, a device combination of catheter A and bronchoscope A is provided, highlighting potentially high bending angle regions. As a second option, a more favorable route is provided in terms of navigation, but the simulated DRR of the approach has a less clear view of the lesion and device tip.

[0102] As an effect, support is provided for the difficult navigation problems posed by the small diameter and tortuosity of peripheral airways, for example, when a bronchoscopist attempts to navigate to a peripheral lesion and encounters the need to detour from the original route planned before the procedure.

[0103] 4 illustrates the basic steps of an example of a method 200 for rerouting a planned path for an interventional device in a lung-related intervention. The method 200 includes the following steps: (1) a preoperative 3D model of at least a portion of the airway of a subject currently undergoing a lung-related procedure is provided as a first substep 202 of the first step; (2) at least one 3D model of at least one available interventional device and physical parameters associated with the at least one available interventional device are provided as a second substep 204 of the first step; (3) a trigger signal for rerouting is received during the lung-related navigation procedure, including a preoperatively planned path to a target location; (4) a current position of the interventional device relative to the preoperative 3D model is provided as a first substep 208 of the second step; and (5) a second substep 210 of the second step, multiple candidate paths are calculated from the current location to the target location, taking into account the at least one 3D model and the associated physical parameters of the at least one available interventional device. For the calculation of the route candidates, a step 212 of simulating a plurality of route candidates is provided, which includes a first sub-step 214 of determining device-route compatibility of the simulated route candidates and a second sub-step 216 of evaluating the simulated route candidates for selection of the best candidate.

[0104] In one example of the method, at least one parameter of the group of interventional device type, interventional device flexibility, interventional device radius, imaging device type, device tip size, needle or forceps size, and navigation path is changed for the simulation.

[0105] In one example of this method, for the evaluation, at least one of the following criteria is measured: - the amount of target tissue that can be biopsied; - Avoidance of important peripheries including important vasculature and at least one of the important nerve tract groups; - Route navigation possibilities, and -Perspective view quality.

[0106] In one example of this method, possible simulated route candidates are provided to the user for user selection.

[0107] In one example of the method, the measured criteria are evaluated numerically and the simulated path with the highest score is selected and proposed as the rerouted path for updated navigation to the target location.

[0108] In one example of the method, to provide a pre-operative 3D model of at least a portion of a tree structure: - providing a preoperative 3D model of at least a portion of a lung of a subject currently undergoing a lung-related procedure; - segmenting the airway from the preoperative 3D model; - extracting an airway tree structure; is provided.

[0109] In one example of the method, a set of devices available in an operating room is provided. A plurality of 3D models for available interventional devices are provided. For the simulation, variation of at least one parameter of the group of the type of interventional device, the flexibility of the interventional device, the radius of the interventional device, the type of imaging device, the size of the device tip, the size of the needle or forceps, and the navigation path is based on the set of available devices.

[0110] In one example of the method, a change indicator is provided to the user when a simulated path based on one of the available but not currently used devices is determined, the change indicator notifying the user that a device change is required to continue navigating the device toward the target.

[0111] In one example of this method, simulated fluoroscopic views of the target site for a given approach angle for each simulated path are generated and presented to the user.

[0112] In one example of this method, for evaluation, the user's previous experience and expertise is taken into account to recommend route and device combinations.

[0113] In one example, a computer program is provided that includes instructions that, when the program is executed by a computer, cause the computer to perform a method of one of the previous examples.

[0114] In one example, a computer program or program element for controlling an apparatus according to one of the above examples is provided, which program or program element is configured to perform the method steps of one of the above method examples when executed by a processing unit.

[0115] In one example, a computer readable medium having stored thereon the computer program of the foregoing example is provided.

[0116] In another exemplary embodiment of the invention, a computer program or a computer program element is provided, characterized in that it is configured to perform, on a suitable system, the method steps of the method according to one of the previous embodiments.

[0117] Thus, a computer program element may be stored in a computing unit or distributed across more than one computing unit that may be part of an embodiment of the present invention. This computing unit may be configured to perform or direct the execution of the steps of the above-mentioned method. Furthermore, it may be configured to operate the components of the above-mentioned apparatus. The computing unit can be configured to operate automatically and / or to execute a user's order. The computer program may be loaded into the working memory of a data processor. The data processor may thus be equipped to perform the method of the present invention.

[0118] Aspects of the present invention may be embodied in a computer program product, which may be a collection of computer program instructions stored on a computer-readable storage device that can be executed by a computer. The instructions of the present invention may be any interpretable or executable code mechanism, including, but not limited to, a script, an interpretable program, a dynamic link library (DLL), or a Java class. The instructions may be provided as a complete executable program, a partial executable program, a modification (e.g., an update) to an existing program, or an extension (e.g., a plug-in) to an existing program. Furthermore, portions of the processing of the present invention may be distributed across multiple computers or processors.

[0119] As described above, a processing unit, e.g., a controller, implements the control method. This controller can be implemented in a variety of ways using software and / or hardware to perform the various functions required. A processor is one example of a controller that uses one or more microprocessors that can be programmed using software (e.g., microcode) to perform the required functions. However, a controller may be implemented with or without a processor, or as a combination of dedicated hardware to perform some functions and a processor (one or more programmed microprocessors and associated circuitry) to perform other functions.

[0120] Examples of controller components used in various embodiments of the present disclosure include, but are not limited to, conventional microprocessors, application specific integrated circuits (ASICs), and field programmable gate arrays (FPGAs).

[0121] This exemplary embodiment of the present invention encompasses both computer programs that use the present invention from the beginning, and computer programs that convert existing programs into programs that use the present invention by means of an update.

[0122] Furthermore, the computer program element may be capable of providing all the steps necessary to fulfill the procedures of the exemplary embodiments of the methods described above.

[0123] According to a further exemplary embodiment of the present invention, a computer readable medium, such as a CD-ROM, is presented, having stored thereon computer program elements, which computer program elements are described by the preceding sections. The computer program may be stored and / or distributed on a suitable medium, such as an optical storage medium or a solid-state medium, supplied together with or as part of other hardware, but may also be distributed in other forms, such as via the Internet or other wired or wireless communication systems.

[0124] However, the computer program may also be presented over a network such as the World Wide Web and can be downloaded into the working memory of a data processor from such a network. According to a further exemplary embodiment of the present invention, a medium for making a computer program element available for downloading is provided, the computer program element being configured to perform a method according to one of the aforementioned embodiments of the present invention.

[0125] It should be noted that the embodiments of the present invention are described with reference to different subject matters. In particular, some embodiments are described with reference to method-type claims, and other embodiments are described with reference to apparatus-type claims. However, those skilled in the art will understand from the above and below description that, unless otherwise specified, any combination of features belonging to one type of subject matter, as well as any combination between features relating to different subject matters, is considered to be disclosed in the present application. However, all features can be combined to provide a synergistic effect greater than the simple sum of the features.

[0126] While the invention has been illustrated and described in detail in the drawings and foregoing description, such illustration and description are to be considered exemplary or explanatory and not restrictive. The invention is not limited to the disclosed embodiments. Other variations to the disclosed embodiments can be understood and effected by those skilled in the art in practicing the claimed invention, from a study of the drawings, the disclosure and the dependent claims.

[0127] In the claims, the word "comprise" does not exclude other elements or steps, and the indefinite article "a" or "an" does not exclude a plurality. A single processor or other unit may fulfill the functions of several items recited in the claims. The mere fact that certain measures are recited in mutually different dependent claims does not indicate that a combination of these measures cannot be used to advantage. Any reference signs in the claims should not be interpreted as limiting the scope.

Claims

1. 1. An apparatus for rerouting a planned path for an interventional device in a pulmonary-related intervention, the apparatus comprising: A data input section; a data storage device; A data processor; an output interface; and the data storage device is configured to provide a pre-operative 3D model of at least a portion of an airway of a subject currently undergoing a lung-related procedure, and to provide at least one 3D model of at least one available interventional device and physical parameters associated with the at least one available interventional device, and the data input unit is configured to provide a current position of the interventional device relative to the pre-operative 3D model; the data processor is configured, upon receiving a trigger signal for rerouting during a lung-related navigation procedure involving a preoperatively planned route to a target location, to calculate a plurality of candidate routes from the current location to the target location taking into account the at least one 3D model and the associated physical parameters of the at least one available interventional device, wherein for calculating the candidate routes, the data processor is configured to simulate a plurality of candidate routes; and for simulating, the data processor is configured to determine device-route compatibility of the simulated candidate routes and evaluate the simulated candidate routes for selection of at least one candidate; the output interface is configured to provide at least one simulated path candidate for further navigation of the interventional device. Device.

2. 10. The device of claim 1, wherein the physical parameters include at least one of the following group: flexibility of the device, variation in flexibility along the length of the device, bend radius of the device, variation in bend radius along the length of the device, surface smoothness of the device and resulting friction with adjacent or adjacent tissue surfaces, and size of the device.

3. The device of claim 1 or 2, wherein at least one parameter of the group of: type of interventional device, flexibility of the interventional device, radius of the interventional device, type of imaging device, size of device tip, size of needle or forceps, and navigation path is changed to simulate.

4. the data input is configured to receive a user interaction to identify a location of an obstruction in the subject's airway; the data processor is configured to take the occlusion into account when simulating the candidate paths.

4. The device of claim 1, 2 or 3.

5. 5. Apparatus according to any one of claims 1 to 4, wherein possible simulated route candidates are provided to the user for user selection.

6. 6. The apparatus according to claim 1, wherein for said evaluation at least one of the following criteria is measured: amount of target tissue that can be biopsied, avoidance of important surroundings including at least one of important vasculature and important nerve tract groups, path navigability and fluoroscopic view quality.

7. 8. The apparatus of claim 1, wherein the data processor is configured to numerically evaluate the measured criteria, select the simulated path with the highest score, and propose the path as a rerouted path for updated navigation to the target location.

8. A plurality of 3D models of a set of available equipment in an operating room are provided; and for simulating, the data processor is configured to base a variation of the at least one parameter on the set of available devices.

8. An apparatus according to any one of claims 1 to 7.

9. the data processor is configured to provide a change indicator to a user when a simulated route based on one of the devices that is available but not currently in use is determined; the change indicator notifying the user that a device change is required to continue navigating the device along the simulated path toward the target.

9. An apparatus according to any one of claims 1 to 8.

10. 10. The apparatus of claim 1, wherein the data processor is configured to generate and present to a user a simulated perspective view of the target region for a given approach angle of each of the simulated paths.

11. 11. The device of claim 1, wherein for said evaluating, the data processor is configured to take into account a user's previous experience and expertise in order to recommend a route and device combination.

12. 1. A system for lung-related navigation guidance, the system comprising: A device for rerouting a planned path for an interventional device in a pulmonary related intervention according to any one of claims 1 to 11; an interventional device positioning device; a user interaction interface; A display device; and the user interaction interface is configured to generate a trigger signal for rerouting during a pulmonary-related navigation procedure; the interventional device position determination device is configured to determine a current position of the interventional device when the trigger signal is generated; the device for rerouting the planned path provides at least one simulated path that serves as navigation for continuing to move the interventional device toward the target, and the display device is configured to provide the at least one simulated path. system.

13. The system of claim 12, wherein an interventional device is provided that moves along the internal airway structure toward the target.

14. 1. A method for rerouting a planned path for an interventional device in a pulmonary-related intervention, the method comprising: providing a pre-operative 3D model of at least a portion of an airway of a subject currently undergoing a lung-related procedure; and providing at least one 3D model of at least one available interventional device and physical parameters associated with the at least one available interventional device; receiving a trigger signal for rerouting during a lung-related navigation procedure having a pre-operatively planned path to a target location; providing a current position of the interventional device relative to the pre-operative 3D model; calculating a plurality of potential paths from the current location to the target location taking into account the at least one 3D model and the associated physical parameters of the at least one available interventional device; and For the calculation of said candidate paths, a step of simulating a plurality of candidate paths is provided; The simulating step includes: determining device-route compatibility of the simulated candidate paths; and evaluating the simulated path candidates to select the best candidate; A method comprising:

15. A computer program comprising instructions that, when executed by a computer, cause the computer to carry out the method of claim 14.

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