Rerouting in lung-related interventions

Abstract

The invention relates to routing in lung-related interventions. In order to provide further improved guidance in lung-related interventions, a device (10) for rerouting a planned path of an interventional device in lung-related interventions is provided. The device comprises a data input (12), a data memory (14), a data processor (16) and an output interface (18). The data input is configured to provide a current position of the interventional device relative to the preoperative 3D model. The data memory 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. The data processor is configured to calculate a plurality of path candidates from a current location to a target location in consideration of the at least one 3D model and associated physical parameters of the at least one available interventional device upon receiving a trigger signal for rerouting during a lung-related navigation procedure, the lung-related navigation procedure includes a pre-procedure planned path to a target location. For calculation of path candidates, the data processor is configured to simulate a plurality of path candidates. For performing the simulation, the data processor is configured to determine device path compatibility of the simulated path candidates and evaluate the simulated path candidates to select at least one candidate. The output interface is configured to provide at least one simulated path candidate for further navigation of the interventional device.

Description

Technical Field

[0001] The present invention relates to routing in lung-related interventions. In particular, the present invention relates to a device for re-routing a planned path of an interventional device in lung-related interventions, a system for lung-related navigation guidance, and a method for re-routing a planned path of an interventional device in lung-related interventions. Background Art

[0002] As an example related to lung bronchoscopy, peripheral lung nodules are widely considered to be challenging transbronchial biopsy (TBB) and transbronchial needle aspiration (TBNA) targets due to the difficulty in navigating catheters and biopsy equipment through narrow and complex peripheral airways. One example of navigation support is CT-guided percutaneous procedures. For example, they may show a high diagnostic yield, such as a diagnostic yield of approximately 90%. Another example is the transbronchial approach, which has a greater safety margin for patients, especially in reducing the risk of dangerous complications such as pneumothorax and bleeding. One of the main obstacles to improving the diagnostic yield of peripheral TBNA may be the challenging navigation setting. However, it has been shown that although modern navigation technologies such as endobronchial ultrasound (EBUS), endobronchial radial ultrasound (r-EBUS) and electromagnetic navigation (EMN) have made transbronchial biopsy and needle aspiration a more attractive proposition, their successful use rate in peripheral lesions is still low relative to other targets and transthoracic approaches. Summary of the invention

[0003] Therefore, further improved guidance in lung-related interventions may be needed.

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

[0005] According to the present invention, a device for rerouting a planned path of an interventional device in a lung-related intervention is provided. The device includes a data input unit, a data storage unit, 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 the airway of an object currently undergoing a lung-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 the current position of the interventional device relative to the preoperative 3D model. The data processor is configured to calculate multiple path candidates from the current position to the target position considering the at least one 3D model and the associated physical parameters of the at least one available interventional device when receiving a trigger signal for rerouting during a lung-related navigation procedure, and the lung-related navigation procedure includes a pre-procedural planned path to the target position. In order to perform the calculation of the path candidates, the data processor is configured to simulate multiple path candidates. In addition, in order to perform the simulation, the data processor is configured to determine the device path compatibility of the simulated path candidates, and evaluate the simulated path candidates to select at least one candidate. The output interface is configured to provide at least one simulated pathway candidate for further navigation of the interventional device.

[0006] As a result, the accessibility of peripheral lesions by a particular device being manipulated through the peripheral airways is determined.

[0007] To navigate to an approach or target, the device geometry is considered. The compatibility of different introducer sheaths for pulmonary bronchoscopy purposes and their limitations in terms of delivery angles of both sheath and needle were simulated.

[0008] According to an example, the physical parameters include at least one of the following group: flexibility of the device, variation of the flexibility along the length of the device, bending radius of the device, variation of the bending radius along the length of the device, surface smoothness and friction generated with adjacent or abutting tissue surfaces, and size of the device.

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

[0010] According to an example, for performing the simulation, at least one parameter from the following group is varied: type of the interventional device, flexibility of the interventional device, radius of the interventional device, imaging device type, device tip size, needle or forceps size, and navigation path.

[0011] By comparing the example of two different needle delivery devices, for example with different delivery angles and with several sheath / needle combinations, optimized rewiring is provided.

[0012] Changing the delivery angle also improved the success rate of reaching the target biopsy site, depending on the lesion size, needle size, and type of introducer sheath, suggesting that the choice of pathway and deployed device are mutually constrained.

[0013] According to an example, the data input is configured to receive a user interaction to identify a location of an obstruction in the airway of the subject. The data processor is configured to take the obstruction into account when simulating the pathway candidates.

[0014] As an advantage, the user can add navigation-related information for routing calculations.

[0015] According to an example, possible simulation path candidates are provided to the user for user selection.

[0016] The user can select the appropriate route.

[0017] According to an example, for said evaluation at least one of the following criteria is measured: amount of target tissue biopsyable, avoidance of critical surroundings of at least one of the group consisting of critical vasculature and critical nerve bundles, path navigability and fluoroscopic view quality.

[0018] This allows identifying the suitability of the paths under the corresponding aspects.

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

[0020] Such an evaluation attempts to provide the user with an objective selection process, further facilitating the user's workflow.

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

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

[0023] According to an example, the data processor is configured to generate and present to the user a simulated fluoroscopic view of the target site for a given approach angle of a corresponding simulated path.

[0024] Because of their similar appearance to fluoroscopic images, the simulated views provide a source of information that is familiar to the user.

[0025] According to the present invention, a system for lung-related navigation guidance is provided. The system includes a device for rerouting a planned path of an interventional device in a lung-related intervention according to one of the aforementioned examples. The system also includes an interventional device position determination device. The system also includes a user interaction interface and a display device. The user interaction interface is configured to generate a trigger signal for rerouting during a lung-related navigation procedure. The interventional device position determination device is configured to determine the current position of the interventional device when the trigger signal is generated. The device for rerouting a planned path provides at least one simulated path, and the at least one simulated path acts as a navigation for moving the interventional device toward the target; and wherein the display device is configured to provide the at least one simulated path.

[0026] According to the present invention, a method for rerouting a planned path of an interventional device in a lung-related intervention is provided. The method comprises the following steps: providing a preoperative 3D model of at least a portion of the airway of an object 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, the lung-related navigation procedure includes a pre-procedural planned path to a target position: providing a current position of the interventional device relative to the preoperative 3D model; taking into account the at least one 3D model and the physical parameters associated with the at least one available interventional device, calculating a plurality of path candidates from the current position to the target position. In order to perform the calculation of the path candidates, a plurality of path candidates are simulated. In addition, the simulation comprises the following steps: determining the device path compatibility of the simulated path candidates; and evaluating the simulated path candidates to select the best candidate.

[0027] Combinations of devices may also constrain each other. For example, once a needle is inserted through a lesion to be biopsied, an introducer sheath that is optimally placed near the lesion may be straightened, which may make the positioning of the device combination less than optimal for the biopsy. There may be tradeoffs for each factor; for example, reducing needle size improves maneuverability and increases the range of successful delivery angles, but reduces the size of the biopsy tissue sample and the range of the sample outside the airway for transbronchial biopsy.

[0028] In addition to device selection and path tortuosity, patient safety is also of concern. The proximity of the navigation path or the needle deployment site to major vessels or other critical structures is thought to avoid negative outcomes.

[0029] As an example, the present invention is intended for peripheral lung bronchoscopy path planning and rerouting, however similar methods can also 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 for diversion in a time-saving manner and increases the likelihood that the user's mission will ultimately be successful. The imaging conditions at this approach angle are also addressed, given the local geometry of the airway relative to the size and shape of the biopsy device, avoiding the outcome of tissue sampling away from the preferred target location or a failed biopsy, thereby preventing this situation from occurring altogether. Particularly in the case of transbronchial lesions (i.e., lesions present outside the airway itself), there may be several paths to the same target location, but which distal branch is entered and where the airway wall is pierced to reach the target location. The accessibility of each option may not be obvious prior to the procedure. The present invention enables optimization of the wiring procedure during the actual movement of the device by the user.

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

[0032] Exemplary embodiments of the present invention will be described below with reference to the following drawings:

[0033] Figure 1 An example of a device for rerouting a planned path of an interventional device in a lung-related intervention is schematically shown.

[0034] Figure 2 An example of a system for lung-related navigation guidance is shown.

[0035] Figure 3a and Figure 3b An example of showing sample path / device selections to the user after a simulation is shown.

[0036] Figure 4 Basic steps of an example of a method for rerouting a planned path of an interventional device in a lung-related intervention are shown. DETAILED DESCRIPTION

[0037] Certain embodiments will now be described in more detail with reference to the accompanying drawings. In the following description, the same reference numerals are used for the same elements even in different drawings. Contents defined in the specification, such as detailed construction and elements, are provided to help fully understand the exemplary embodiments. In addition, well-known functions or constructions are not described in detail because they would obscure the embodiments with unnecessary details. In addition, when preceding a list of elements, expressions such as "at least one of ... " would modify the entire list of elements without modifying a single element in the list.

[0038] Figure 1 An example of a device 10 for rerouting a planned path of an interventional device in a lung-related intervention is schematically shown. The device 10 includes a data input 12, a data storage 14, a data processor 16, and an output interface 18. The data input 12 is configured to provide a current position of an 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 an object currently undergoing a lung-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 at least one available interventional device. The data processor 16 is configured to calculate multiple path candidates from the current position to the target position taking into account the at least one 3D model and the associated physical parameters of at least one available interventional device when receiving a trigger signal for rerouting during a lung-related navigation procedure, the lung-related navigation procedure including a preoperatively planned path to the target position. In order to perform the calculation of the path candidates, the data processor 16 is configured to simulate the multiple path candidates. Furthermore, for simulation, the data processor 16 is configured to determine device path compatibility of the simulation path candidates and evaluate the simulation path candidates to select at least one candidate. The output interface 18 is configured to provide at least one simulation path candidate for further navigation of the interventional device.

[0039] A first dashed arrow 20 indicates data input of, for example, the current position of the interventional device relative to the pre-operative 3D model.

[0040] A second dashed arrow 22 indicates the data output of at least one simulated pathway candidate, for example for further navigation of the interventional device.

[0041] A dashed box 24 indicates a display as an example of presenting simulation path candidates to the user.

[0042] Box 26 indicates an option according to which the data input 12, the data storage device 14, the data processor 16 and the output interface 18 are provided in an integrated manner, for example in a common housing. However, they may also be integrated together in a different combination, or even arranged as separate components.

[0043] In an example, the pre-operative 3D model includes at least a portion of a tree structure of the airway of the subject.

[0044] The plurality of pathway candidates provide a plurality of routes, from which a route is then selected for navigating or maneuvering the interventional device at least partially within the airway structure of the subject.

[0045] Using simulations, it is possible to determine whether the currently selected path is compatible with the currently selected device and also to assess the quality of the selection according to the above parameters. The simulation comprises two steps: 1) determining device / path compatibility and 2) assessing path quality.

[0046] The physician triggers a simulation during surgery when it is determined that the planned path fails to reach the target site and a new path is required.

[0047] In a first step, the simulation determines for a set of available equipment in the operating room whether their geometry can physically reach the target site through the selected path. As examples, different ways of obtaining this information are provided, such as system documentation, equipment identification, etc.

[0048] In an example, a device compatibility simulation with high complexity includes physics-based modeling of the device through multiple pathway candidates using a patient-specific airway model derived from preoperative imaging. Potential advantages can be provided if the manufactured device used has known physical properties and the CAD model is easily available and integrated into the operating and imaging systems.

[0049] As examples, factors involved in the path selection process include:

[0050] Device parameters, such as needle / catheter / imager(s) size, shape, flexibility;

[0051] Pathway navigability, such as airway diameter, bend angles, tortuosity;

[0052] Navigability of the device at the distal end, e.g., while the flexibility of the device may be known, 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, thus requiring simulation;

[0053] biopsy site, such as needle approach angle, biopsy sample size / location, overlap with target lesion;

[0054] Safety factors, such as proximity to vessels / structures; and

[0055] Viewing angle, such as the ability to see the target and its relationship to access equipment in an intraoperative modality from a given configuration.

[0056] In the example, the model makes a step-by-step comparison between devices and paths. Inputs to a simpler simulation may include: 1. Device parameters D i ={d θ , d r , …}, where d θ Indicates the bending limit of each section of the equipment, d rrepresents the radius of the device along its length, etc. Here, "device" includes each device I combination of guide catheter, (one or more) imaging device and biopsy device; and 2. Airway parameter A j ={a θ , a r , …}, where a θ represents the minimum bending angle required to pass through each section of the airway, a r represents the radius of the airway over the path length for a set of path candidates j, etc. Given these inputs, the simulator determines for each set of devices and airways whether any physical constraints of the airway exceed the limits of the combined device.

[0057] The present invention addresses the dependency of some of the above factors on other factors, which creates a high-dimensional problem that is solved on the fly by a simulation provided as an intraoperative rewiring that takes into account the possibility of optimizing for multiple equipment options. While preoperative planning is based on preoperative knowledge, the rewiring of the present invention allows for the consideration of knowledge acquired during the operation.

[0058] In an example, physics-based modeling is provided, which is based on devices whose characteristics are known in advance.

[0059] The term "data input" relates to providing or supplying data for a data processing step. The data input may also be referred to as an image data input. The 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 an example, the image data input may be data-connected to an imaging source device.

[0060] The term "data processor" relates to a part of a processor or processor device provided for performing a computational step 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 an example, the data processor is data connected to a data input and an output interface.

[0061] The term "output interface" relates to an interface for providing processed or calculated data for further purposes. An output interface may also be referred to as an output portion or an output unit. In an example, the output interface may be data connected to a display device or a display apparatus. In another example, the output portion is data connected to a display. As an example, a signal of a controller may be provided by an output interface.

[0062] The term "current position" relates to the position of the device achieved during the actual guided movement. As an example, the current position refers to the front (or distal) tip of the interventional device.

[0063] In an example, the interventional device is provided as a navigation catheter, or as a biopsy device or an imaging device.

[0064] The term "path candidate" relates to a path, ie a route, identified by the data processor as suitable for navigation towards a target. A path candidate may be suitable for currently provided interventional devices. In an option, a path candidate also relates to a path suitable for one or more other potentially available interventional devices.

[0065] The term "device path compatibility" relates to the identified path, ie the generally possible route, and its suitability for a specific device. It is checked or verified that a certain intervention device can actually maneuver through the identified path.

[0066] The term "evaluation" relates to determining or analyzing the suitability of a path compared to other paths. Evaluation may also be referred to as an evaluation or weighting based on the values ​​of the respective paths. Evaluations are provided in order to identify the most promising path, or even the best path. Evaluations may also include different value categories, and the values ​​may be provided to the user. For example, a particular path may be shorter than other paths, but may be more difficult to maneuver the device along the path. Another example is a less complex path, but this may result in a less than ideal angle for performing the biopsy action.

[0067] Examples of pulmonary interventions are lung biopsy procedures and lung bronchoscopy procedures.

[0068] exist Figure 1 In examples not shown in further detail, the physical parameters include at least one of the following group: flexibility of the device, variation in flexibility along the length of the device, a bending radius of the device, variation in the bending radius along the length of the device, surface smoothness and friction with adjacent or abutting tissue surfaces, and size of the device.

[0069] exist Figure 1 In an example not shown in further detail in the drawings, for simulation, at least one parameter from the following group is changed: type of interventional device, flexibility of interventional device, radius of interventional device, type of imaging device, device tip size, needle or forceps size, and navigation path.

[0070] exist Figure 1 In an example not shown in further detail in FIG. 1 , data input 12 is configured to receive user interaction to identify a location of an obstruction in the airway of a subject. Data processor 16 is configured to take the obstruction into account when simulating path candidates.

[0071] This allows the user to modify the information that is the basis for further route determination. In an option, the obstruction is transferred or entered into a 3D model of the airway structure.

[0072] exist Figure 1 In an example not shown in further detail in FIG. 1 , possible simulation path candidates are provided to a user for user selection.

[0073] Finally, a set of top device / pathway candidates are shared with the physician for final review. As an option, a warning or other signal is indicated if a particular pathway requires a device change (e.g., a smaller device has a higher chance of reaching the target), or if the currently deployed device is incompatible with all pathway candidates, or if the quality scores of all pathways for the current device are below a threshold. A simulated fluoroscopic view of the target site for a given approach angle is also shown.

[0074] exist Figure 1 In an example not shown in further detail in , for evaluation, at least one of the following criteria is measured: amount of target tissue that can be biopsied, avoidance of critical surroundings of at least one of a group including critical vasculature and critical nerve bundles, path navigability, and fluoroscopic view quality.

[0075] The term "critical" relates to blood vessels or nerve bundles that could cause serious injury or complications if affected during a biopsy or other interventional procedure.

[0076] In the second step, the quality of compatible paths is evaluated and the best option is presented to the user. In the example, the quality is determined by measuring:

[0077] 1. The amount of target tissue that can be biopsied based on the needle approach angle and needle size: Once the device has reached the target site, this can be calculated by measuring the overlap between the position of the simulated needle when fully deployed and the segmented lesion in the pre-operative image. The mass can be calculated in terms of tissue volume or a binary value indicating whether a certain threshold volume has been reached.

[0078] 2. Ability to avoid critical vasculature: Quality can be calculated by measuring the minimum distance of the needle from any major vessel throughout the simulation procedure.

[0079] 3. Path navigability: The quality of path navigability can be measured by the maximum bending angle or maximum strain imposed on the device during operation calculated by the above simulations. A less tortuous path will be easier to traverse.

[0080] 4. Fluoroscopic view quality: The quality of the fluoroscopic view at the target site is very valuable for the physician to confirm whether the biopsy was successful. This can be estimated by calculating digitally reconstructed radiographs of the preoperative computed tomography volume and changing the C-arm position until the view with the least obstruction is found (obstructions can include bone structures, etc.). In addition, the view coplanar with the direction of device movement toward the target is the best choice for evaluating device penetration into the target. The degree of occlusion and device visibility at the approach angle for each path are used as measures of view quality.

[0081] exist Figure 1In an example not shown in further detail in FIG. 1 , the data processor 16 is configured to numerically evaluate the measured criteria. The data processor 16 is also configured to select the simulated path with the highest score. The data processor 16 is also configured to suggest the path as a rerouting path for updated navigation to the target location.

[0082] In an example, to provide a preoperative 3D model of at least a portion of the tree structure, the data processor 16 is configured to provide a preoperative 3D model of at least a portion of the lungs of a subject currently undergoing a lung-related procedure; segment the airways from the preoperative 3D model. The data processor 16 is further configured to extract the tree structure of the airways.

[0083] In an example, a pre-operative 3D image is provided instead of a pre-operative 3D model of the lungs.

[0084] exist Figure 1 In an example not shown in further detail in FIG. 1 , a plurality of 3D models of a set of available equipment in an operating room are provided. For the simulation, the data processor 16 is configured to base a change to at least one parameter on the set of available equipment.

[0085] In other words, for parameter changes, only those parameter combinations are applied that are actually available in the operating room.

[0086] In the options, a set of additional multiple 3D models are provided that are known to be currently unavailable for equipment but can be deployed within a preset amount of time.

[0087] exist Figure 1 In an example not shown in further detail in FIG. 1 , the data processor 16 is configured to provide a change indicator to the user when determining a simulated path based on one of the available but currently unused devices. The change indicator informs the user that a change of device is required to continue navigating the device along the simulated path toward the target.

[0088] In an example, the data processor 16 is configured to determine a probability index for the simulated path and provide the probability index to the user. This may be useful, for example, where information about the actual airway structure and geometry is incomplete.

[0089] exist Figure 1 In an example not shown in further detail in FIG. 1 , the data processor 16 is configured to generate a simulated fluoroscopic view of the target site for a given approach angle of a corresponding simulated path and present it to a user.

[0090] exist Figure 1 In an example not shown in further detail in FIG. 1 , for the purpose of evaluation, the data processor 16 is configured to take into account the user's previous experience and expertise to recommend a route and equipment combination.

[0091] In the example, a workflow and setup is provided, including:

[0092] A preoperative 3D model of the lungs or anatomy of an individual patient to be operated on; the model may be in the form of a point cloud, mesh, volumetric image (e.g., computed tomography), or other form;

[0093] 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, introducer 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 bend angle over the length of the device, the maximum strain that the device can withstand, etc.;

[0094] The preoperative image processing module segments the airway from the preoperative image or model and extracts the tree structure of the airway (using centerline or machine learning or other methods);

[0095] a simulation module that initiates a simulation to determine device / path compatibility; the simulation varies all controllable parameters between possible devices and paths to determine which are physically feasible; this may include using the 3D model of the second element and the airway segmentation of the third element to perform a physics-based simulation that tests the device traversing through the airway and verifies whether there may be any unpassable collisions or turns;

[0096] A simulation module that evaluates all candidate device / path combinations from the fourth element above and produces a metric that describes the quality of each option.

[0097] In another embodiment, a simulation is provided that compares the maximum bend angle and other constraints of the device to the desired bend angle and other constraints of the airway to identify any discrepancies.

[0098] In another embodiment, a neural network may be trained to assess compatibility between device type and segmented airways.

[0099] Parameters to be varied may include: catheter type / flexibility / radius; imaging device type and combination; needle / forceps size; and navigation path.

[0100] The measurement results are derived from:

[0101] 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 element above;

[0102] Safety measurements: distance of the needle from any critical anatomical structures throughout the procedure;

[0103] Path navigability measures: the “difficulty” of traversing each chosen path, as estimated by the amount of curvature of the path or the maximum bend angle required or other parameters; and

[0104] View Quality: The amount of occlusion caused by the anatomy of the C-arm viewing angle associated with a specific needle approach angle determined by simulating the fourth element above. The C-arm viewing angle for each pathway / device combination can be the least occluded view orthogonal to the needle travel direction containing the needle and the lesion. This view can be simulated from preoperative CT images by generating a DRR.

[0105] A processing controller that weights the quality measures of the fifth element above and selects a set of best path candidate / device combinations for the user.

[0106] A visualization module that displays the pathway candidate / device combinations along with quality measures and simulated fluoroscopic images from candidate views and alerts the user when there are higher quality options that require changing the deployed device and allows the user to decide whether using an easier pathway is worth the time spent changing the device.

[0107] As an option, a user interface element is provided that initiates the simulation and visualization process of the fourth to seventh elements described above.

[0108] In the example, the user's prior experience and expertise are also considered to make personalized recommendations. Certain paths and maneuvers may be routine for experienced users, but still present challenges for novice users. Additionally, even some experienced users may not have been trained in the use of certain devices (e.g., R-EBUS). In the example, the system tracks the user's ability to successfully navigate to and biopsy lesions using recommended path / device combinations over several procedures and / or a period of time, and adaptively learns to weight the quality metrics so that combinations that the user generally performs well on receive higher weights than combinations that the user finds challenging.

[0109] According to one aspect, a dynamically calculated path / device combination is provided that optimizes the navigability of the path, the approach angle of the biopsy device, the viewing angle in intraoperative imaging, and patient safety. It is capable of performing this calculation intraoperatively to meet the needs of fast and accurate rerouting and assessing the need for device replacement in the event that the original planned path(s) cannot reach the target site.

[0110] According to one aspect, device selection is added to the framework. This is particularly advantageous when knowledge of catheters / needles is provided, so that compatible device / access combinations can be modeled more accurately.

[0111] In fact, bronchoscopy or lung biopsy procedure times were shortened in cases where deviations from the original planned path were necessary.

[0112] As an option, automatic and dynamic path rerouting is provided in case of failure of the planned path.

[0113] As another option, equipment selection / change recommendations are provided in case the currently deployed equipment is not compatible with the newly calculated path.

[0114] As another option, fluoroscopic view recommendations are provided for new pathway anatomy configurations.

[0115] Figure 2 An example of a system 50 for lung-related navigation guidance is shown. The system 50 includes an example of a device 10 for rerouting a planned path of an interventional device in a lung-related intervention according to one of the aforementioned examples. In addition, an interventional device position determination device 52 is provided. In addition, 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 position determination device 52 is configured to determine the current position of the interventional device when the trigger signal is generated. The device 10 for replanning a planned path provides at least one simulated path, and the at least one simulated path acts as a navigation for moving the interventional device toward a target. The display device 56 is configured to provide the at least one simulated path.

[0116] Note that, for example, a connection line between the interventional device position determining device 52 and the device 10 for rewiring a planned path of an interventional device in lung-related interventions, or a connection line between the display device 56 and the device 10 for rewiring a planned path of an interventional device in lung-related interventions, or a connection line between the device 10 for rewiring a planned path of an interventional device in lung-related interventions and the console 62 indicates a data connection, which can be wired or wireless.

[0117] In an example, the interventional device position determination means comprises at least one of the group of an X-ray imaging device, an electromagnetic sensor and an ultrasound imaging device.

[0118] exist Figure 2 , a system 50 for lung-related navigation guidance is shown in the context of an interventional room (e.g., a cathlab) in a medical facility. As an option, an object support 58 is shown, on which an object 60 (e.g., a patient) can be arranged. As an option, a console 62 is shown in the right foreground. In addition, as an option, an imaging device 64 is shown. As an example, the imaging device 64 includes an X-ray imaging device having an X-ray source 66 and an X-ray detector 68 mounted to opposite ends of a movable C-arm 70.

[0119] In one example, if Figure 2 As shown, as an option, an interventional device 72 is provided for movement along the interior of the airway structure towards the target.

[0120] In an example, a system is provided for optimizing navigation pathways and device selection based on the current state of a procedure to maximize pathway navigability, suitability of needle approach angles, visibility of target sites on imaging, and avoidance of critical vasculature.

[0121] The term "subject" may also be referred to as an individual. A "subject" may also be referred to as a patient, but it is worth noting that this term does not indicate whether the subject actually suffers from any disease.

[0122] Figure 3a and Figure 3b An example of showing sample path / device selections to the user after a simulation is shown. Figure 3a and Figure 3b In the drawings, similar elements are indicated by the same reference numerals. Figure 3b Use single quotes '.

[0123] Simulated image 100 is shown with a complex airway structure 102. Device 104 is shown inserted along a path toward target 106. The target lesion site is highlighted. An illustration and indication of a catheter 110 is shown in the center portion. Figure 3a In FIG. 1 , catheter 110 is labeled as “catheter A”; in FIG. Figure 3b In FIG. 1 , catheter 110 ′ is labeled “catheter B.” In addition, a diagram and indication of a bronchoscope 112 are shown. Figure 3a In the bronchoscope, the bronchoscope is labeled "Bronchoscope A"; in Figure 3b In FIG. 1 , bronchoscope 112 ′ is labeled “Bronchoscope B”.

[0124] In addition, the optimal digitally reconstructed radiographic image (DRR) is shown at the bottom right of each option. Figure 3a In the figure, the digitally reconstructed radiological image is indicated by reference numeral 114; Figure 3b In FIG. 1 , the digitally reconstructed radiological image is denoted by reference numeral 114 ′.

[0125] As a first option, Figure 3a As shown, a device combination of catheter A and bronchoscope A is provided, and potential high bend angle areas are highlighted. As a second option, a more favorable route is provided in terms of navigation, but the simulated DRR of this method has a more obscure view of the lesion and the device tip.

[0126] Thus, support is provided for challenging navigation problems posed by the small diameter and tortuosity of the peripheral airways, such as when the bronchoscopist needs to deviate from the original path planned prior to the procedure when attempting to navigate to a peripheral lesion.

[0127] Figure 4 The basic steps of an example of a method 200 for rerouting a planned path of an interventional device in a lung-related intervention are shown. The method 200 comprises the following steps: as a first substep 202 of the first step, a preoperative 3D model of at least a portion of the airway of an object currently undergoing a lung-related procedure is provided. As a second substep 204 of the first step, 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. At the second step 206, a trigger signal for rerouting during a lung-related navigation procedure is received, the lung-related navigation procedure comprising a pre-procedural planned path to a target position: as a first substep 208 of the second step, a current position of the interventional device relative to the preoperative 3D model is provided. As a second substep 210 of the second step, a plurality of path candidates from the current position to the target position are calculated taking into account the at least one 3D model and the associated physical parameters of the at least one available interventional device. In order to perform the calculation of the path candidates, a step 212 of simulating a plurality of path candidates is provided. The simulation comprises as a first sub-step 214 a step of determining device path compatibility of simulation path candidates; and as a second sub-step 214 a step 216 of evaluating the simulation path candidates to select the best candidate.

[0128] In an example of the method, for the simulation at least one parameter from the following group is varied: type of interventional device, flexibility of interventional device, radius of interventional device, imaging device type, device tip size, needle or forceps size, and navigation path.

[0129] In an example of the method, for the evaluation at least one of the following criteria is measured:

[0130] the amount of target tissue that can be biopsied;

[0131] avoiding a critical surrounding environment of at least one of the group consisting of critical vasculature and critical neural bundles;

[0132] Path navigability; and

[0133] Fluoroscopic view quality.

[0134] In an example of the method, possible simulation path candidates are provided to the user for user selection.

[0135] In an example of the method, the measured criteria are numerically evaluated, and wherein the highest scoring simulated path is selected and proposed as a rerouted path for updated navigation to the target location.

[0136] In an example of the method, in order to provide a pre-operative 3D model of at least a portion of the tree structure, the following steps are provided:

[0137] providing a pre-operative 3D model of at least a portion of a lung of a subject currently undergoing said lung-related procedure; and

[0138] Segmenting the airway from the preoperative 3D model; and

[0139] The tree structure of the airway is extracted.

[0140] In an example of the method, a set of available devices in an operating room is provided. A plurality of 3D models for available interventional devices are provided. To perform the simulation, a change to at least one parameter in the following group is based on the set of available devices: type of interventional device, flexibility of interventional device, radius of interventional device, type of imaging device, device tip size, needle or forceps size, and navigation path.

[0141] In an example of the method, a change indicator is provided to the user upon determining a simulated path based on one of the available but currently unused devices. The change indicator notifies the user that a device change is required to continue navigating the device toward the target.

[0142] In an example of the method, a simulated fluoroscopic view of the target site is generated for a given approach angle of a corresponding simulated path and presented to a user.

[0143] In an example of the method, for evaluation purposes, the user's prior experience and expertise are considered to recommend a route and equipment combination.

[0144] In an example, there is provided a computer program comprising instructions which, when executed by a computer, cause the computer to perform the method of one of the preceding examples.

[0145] In an example, a computer program or a program element for controlling an apparatus according to one of the above-described examples is provided, which program or program element, when executed by a processing unit, is adapted to perform the method steps of one of the above-described method examples.

[0146] In an example, a computer readable medium storing the computer program of the foregoing examples is provided.

[0147] In a further exemplary embodiment of the present invention, a computer program or a computer program element is provided, which is characterized by being adapted to execute the method steps of the method according to one of the preceding embodiments on a suitable system.

[0148] Therefore, the computer program element can be stored on a computer unit or distributed on multiple computer units, which can also be a part of an embodiment of the present invention. The computing unit can be suitable for executing or causing the steps of the above method to be executed. In addition, it can be suitable for operating the components of the above device. The computing unit can be suitable for automatic operation and / or execution of user's commands. The computer program can be loaded into the working memory of the data processor. Therefore, the data processor can be equipped to perform the method of the present invention.

[0149] Aspects of the present invention can be implemented in a computer program product, which can be a set of computer program instructions that can be executed by a computer and stored on a computer-readable storage device. Instructions of the present invention can be any interpretable or executable code mechanism, including but not limited to scripts, interpretable programs, dynamic link libraries (DLLs) or Java classes. Instructions can be provided as complete executable programs, partial executable programs, modifications (e.g., updates) to existing programs, or extensions (e.g., plug-ins) to existing programs. In addition, partial processing of the present invention can be distributed on multiple computers or processors.

[0150] As described above, a processing unit (e.g., a controller) implements a control method. A controller can be implemented in a variety of ways using software and / or hardware to perform the various functions required. A processor is an 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, and may also be implemented as a combination of dedicated hardware for performing some functions and a processor (e.g., one or more programmed microprocessors and associated circuits) for performing other functions.

[0151] Examples of controller components that may be employed 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).

[0152] This exemplary embodiment of the invention covers both a computer program that right from the beginning uses the invention and a computer program that by means of an update turns an existing program into a program that uses the invention.

[0153] Furthermore, the computer program element may be able to provide all necessary steps to implement the process of an exemplary embodiment of the method as described above.

[0154] According to another exemplary embodiment of the present invention, a computer readable medium, such as a CD-ROM, is proposed, wherein the computer readable medium has a computer program element stored thereon, the computer program element being described by the previous section. The computer program may be stored and / or distributed on a suitable medium, such as an optical storage medium or a solid-state medium provided 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 telecommunication systems.

[0155] However, the computer program may also be presented over a network such as the World Wide Web and may be downloaded from such a network into a working memory of a data processor. According to another exemplary embodiment of the present invention, a medium for making a computer program element available for download is provided, the computer program element being arranged to perform a method according to one of the aforementioned embodiments of the present invention.

[0156] It must be noted that 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, while other embodiments are described with reference to device type claims. However, a person skilled in the art will appreciate from the above and following descriptions that, unless otherwise stated, any combination of features relating to different subject matters, in addition to any combination of features belonging to one type of subject matter, is also considered to be disclosed with the present application. However, all features may be combined to provide a synergistic effect, rather than just a simple addition of features.

[0157] Although the present invention has been illustrated and described in detail in the drawings and the foregoing description, such illustration and description are to be considered illustrative or exemplary rather than restrictive. The present invention is not limited to the disclosed embodiments. Other variations to the disclosed embodiments may be understood and effected by those skilled in the art in practicing the claimed invention by studying the drawings, the disclosure, and the appended claims.

[0158] In the claims, the word "comprising" does not exclude other elements or steps, and the attributive "a" or "an" does not exclude a plurality. A single processor or other unit may fulfill the functions of several items repeatedly cited in the claims. The mere fact that certain measures are repeatedly cited in mutually different dependent claims does not mean that a combination of these measures cannot be used to advantage. Any reference signs in the claims should not be construed as limiting the scope.

Claims

1. A device (10) for rerouting a planned path of an interventional device in a lung-related intervention, the device comprising: Data input unit (12); Data storage (14); Data processor (16); as well as Output interface (18); wherein the data storage 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 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; wherein the data input is configured to provide a current position of the interventional device relative to the pre-operative 3D model; wherein the data processor is configured to: upon receiving a trigger signal for rewiring during a lung-related navigation procedure, calculate a plurality of path candidates from the current position to a target position taking into account the at least one 3D model and associated physical parameters of the at least one available interventional device, the lung-related navigation procedure including a pre-procedural planned path to the target position; wherein, in order to perform the calculation of the path candidates, the data processor is configured to simulate a plurality of path candidates; and wherein, in order to perform the simulation, the data processor is configured to determine device path compatibility of simulated path candidates; and evaluate the simulated path candidates to select at least one candidate; and The output interface is configured to provide at least one simulated path candidate for further navigation of the interventional device.

2. The device according to 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, bending radius of the device, variation in bending radius along the length of the device, surface smoothness and friction with adjacent or abutting tissue surfaces, and size of the device.

3. The device according to claim 1 or 2, wherein: To perform the simulation, at least one parameter from the following group is varied: type of the interventional device, flexibility of the interventional device, radius of the interventional device, imaging device type, device tip size, needle or forceps size, and navigation path.

4. The apparatus according to claim 1, 2 or 3, wherein: The data input is configured to receive a user interaction to identify a location of an obstruction in the airway of the subject; and Wherein, the data processor is configured to take the blocking into account when simulating the path candidates.

5. The device according to any one of the preceding claims, wherein: Possible simulation path candidates are provided to the user for user selection.

6. The device according to any one of the preceding claims, wherein: For said evaluation, at least one of the following criteria is measured: amount of target tissue that can be biopsied, avoidance of critical surroundings of at least one of the group consisting of critical vasculature and critical nerve bundles, pathway navigability, and fluoroscopic view quality.

7. The device according to any one of the preceding claims, wherein: The data processor is configured to: numerically evaluate the measured criteria; select a simulated path with the highest score; and recommend the path as a rerouted path for updated navigation to the target location.

8. The device according to any one of the preceding claims, wherein providing multiple 3D models of a set of equipment available in an operating room; and Therein, to perform the simulation, the data processor is configured to base a change to at least one parameter on the set of available devices.

9. The device according to any of the preceding claims, wherein: The data processor is configured to provide a change indicator to the user when a simulated path is determined based on one of the available but currently unused devices; and Wherein the change indicator notifies the user that a device change is required to continue navigating the device along the simulated path toward the target.

10. The device according to any of the preceding claims, wherein: The data processor is configured to generate and present to the user a simulated fluoroscopic view of a target site for a given approach angle of a corresponding simulated path.

11. The device according to any of the preceding claims, wherein To perform the evaluation, the data processor is configured to take into account the user's prior experience and expertise to recommend a route and equipment combination.

12. A system (50) for lung-related navigation guidance, comprising: Device (10) for rerouting a planned path of an interventional device in a lung-related intervention according to one of the preceding claims; Intervention device position determination device (52); User interaction interface (54); and Display device (56); wherein the user interaction interface is configured to generate a trigger signal for rewiring during a lung-related navigation procedure; Wherein, the interventional device position determination means is configured to determine the current position of the interventional device when generating the trigger signal; wherein the device for rerouting a planned path provides at least one simulated path, the at least one simulated path serving as a navigation for moving the interventional device toward the target; and wherein the display device is configured to provide the at least one simulated path.

13. The system according to claim 12, wherein: An interventional device (72) is provided for movement along the interior of an airway structure toward a target.

14. A method (200) for rerouting a planned path of an interventional device in a lung-related intervention, the method comprising the following steps: providing (202) a pre-operative 3D model of at least a portion of an airway of a subject currently undergoing a lung-related procedure; and providing (204) 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 (206) a trigger signal for rerouting during a lung-related navigation procedure, the lung-related navigation procedure comprising a pre-procedural planned path to a target location: providing (208) a current position of the interventional device relative to the pre-operative 3D model; calculating (210) a plurality of path candidates from the current position to the target position taking into account the at least one 3D model and associated physical parameters of the at least one available interventional device; In order to calculate the path candidates, a simulation (212) of a plurality of path candidates is provided; and Wherein, the simulation comprises the following steps: Device path compatibility of simulation path candidates is determined (214); and the simulation path candidates are evaluated (216) to select the best candidate.

15. A computer program comprising instructions which, when said program is executed by a computer, cause said computer to carry out the method according to claim 14.

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