TWO-PRONGED APPROACH FOR BRONCHOSCOPY

Via a trachea (5) of the subject, an end of a first tube (120) is advanced along a first airway route (127) to an imaging site (20) within the lung (55). Independently of the first tube, an end of a second tube (130) is advanced along a second airway route (130) to a tool site (30) within the lung. While the first tube remains extended along the first route and the second tube remains extended along the second route, an imaging device (128), extended from the end of the first tube, is used to image a tool (138) extended from the end of the second tube, and a target (40) within the lung. The tool can be used to perform a procedure on the target, guided by the imaging of the target and the tool. Other embodiments are also described.

FIELD OF THE INVENTION

Some applications of the present invention relate in general to medical procedures. More specifically, some applications of the present invention relate to performing a bronchoscopic procedure under ultrasound guidance.

BACKGROUND

Bronchoscopic procedures typically involve advancing a tube through a mouth or nose of a subject, down a trachea, and into the airways of a lung of the subject. In some instances, the bronchoscopic procedure may involve removing a foreign object that has become stuck within the lung, or performing a biopsy or treatment on tissue of the lung. In some such instances, a biopsy or treatment tool is used to perform the procedure.

SUMMARY OF THE INVENTION

The present disclosure relates to methods and systems of performing a bronchoscopic procedure guided by real-time imaging of the lungs of the subject. The method comprises using a transbronchial approach to position an imaging device in the lung of the subject, at least partly independently of the positioning of the medical tool used to perform the procedure. These techniques may advantageously allow the imaging device to be positioned optimally for viewing the operation of the medical tool at a target site within the lung. These techniques may also advantageously allow for repositioning of the imaging device (e.g. mid-procedure) without undesirably also repositioning the medical tool.

Typically, prior to the procedure, the target site to be operated on (hereinbelow referred to as “the target”) and/or one or more routes to the target are predetermined (e.g. pre-procedurally designated)—e.g. facilitated by pre-procedure imaging such as, but not limited to, CT or MRI. However, the procedure may alternatively be performed as part of an exploratory bronchoscopy procedure—e.g. with the routes and/or target being determined intraoperatively. Examples of targets include tumors, lesions, or foreign objects trapped in the lung. The procedure may involve performing a biopsy on the target, or removing the target.

The method may comprise advancing a sheath into a trachea of a subject. The sheath may be advanced into a bronchus of the lung. The target may be significantly distal to the primary and/or secondary bronchi of the lung, for example, it may be in a fourth, fifth, sixth, or greater generation of the bronchi, or even in the bronchioles of the lung. The target may even be situated outside of the bronchi—e.g. in the parenchyma. Typically, advancement of the sheath is terminated prior to the sheath reaching the target, such that the distal end of the sheath is proximal from (i.e. less deep into the airways) than the target itself. For example, the sheath may be advanced only as far as the trachea, or only as far as a primary bronchus, whereas the target may be situated at, or adjacent to, a third-, fourth-, fifth-, sixth-, or higher-generation bronchus. In some applications, the sheath is not advanced into the trachea or bronchus (e.g. it may be placed into the mouth of the patient but does not reach the trachea).

Two flexible tubes (e.g. two catheters) are then advanced out of the sheath and along alternate routes, branching away from each other as they progress deeper into the lung, such that the ends of the tubes become disposed in different bronchi or bronchioles. For example, the end of the first tube may become disposed in a first sixth-generation bronchus, and the end of the second tube may become disposed in a different sixth-generation bronchus. Alternatively, the first tube may be advanced to a different generation-depth than the second tube, for example the first tube may be advanced only to a fourth-generation bronchus, with the second tube advanced to a seventh-generation bronchus. Advancement of the sheath may be terminated at a fork in the airways that has been predetermined to be appropriate for advancement of both the first and second tubes—e.g. the fork being common to the first and second routes. In some applications, the first tube and the second tube are advanced individually through the trachea and into the airways without use of a sheath.

Although the first and second tubes may initially diverge as each is advanced along a different airway branch, they may subsequently converge as they approach the target. That is, the distal part of the first route, along which the first tube advances, may converge with the distal part of the second route, along which the second tube advances.

In some applications, each of the first and second tubes is guided towards its respective site using a camera disposed at its distal end to provide an operator with a view of the airways. In some such applications, these cameras are additionally used to guide the passage of the sheath down the trachea and into the bronchus, e.g. with the tubes disposed within the sheath and the cameras disposed at the distal ends of the tubes, which themselves are close to or at the distal end of the sheath.

In some applications in which cameras are used to direct the tubes towards their respective sites, once the tubes are positioned at their respective sites, the cameras may be withdrawn through the tubes and out of the subject. In some applications, an ultrasound transceiver is then passed through the first tube and out of the first tube's distal end, and a medical tool is passed through the second tube, and out of the second tube's distal end. In some applications, a camera is disposed at the distal end of the sheath, external to the tubes, such that the camera may remain in place while the tubes are advanced beyond the end of the sheath, or while the tool or the ultrasound transceiver are passed through the tubes.

For some applications, one or both of the cameras may remain at the distal end of the tubes, and an ultrasound transceiver may be delivered through a working channel of the first tube and out of its distal end, and/or a medical tool may similarly be delivered through a working channel of the second tube and out of its distal end.

In some applications, the first tube is advanced to the imaging site with an ultrasound transceiver already disposed at its distal end, and the second tube is advanced to the tool site with the medical tool already at its distal end.

The imaging and tool sites are typically chosen (e.g. designated) such that the target and the tool will be in the field of view of the ultrasound transceiver. For example, the target may be disposed between the ultrasound transceiver and the medical tool—e.g. with the ultrasound transceiver “looking back” or “looking over” at the target and the medical tool. Alternatively, the medical tool may be closer than the target to the ultrasound transceiver—e.g. with the target behind the medical tool, from the perspective of the ultrasound transceiver.

In some applications, the sites and/or routes are pre-procedurally planned (i.e. designated), e.g. in order to provide a viable pair of sites for the transceiver and tool during the procedure. The pre-procedure planning of the sites and/or routes may be performed manually—e.g. by a physician. However, the planning may alternatively be facilitated at least in part by a system, e.g., a data-processing system or a computer processor, running software and/or an algorithm. Route planning may be facilitated by a computer model (e.g. a schematic representation and/or an image) of the lung of the subject, which may be derived from an initial imaging of the lung, such as a three-dimensional (3D) CT or MRI image. The computer model typically includes a representation of the target site and of the airways of the lung. In some applications, the representation may include a volumetric body. In some applications, the representation may include a vector-based map. In some applications, both a volumetric body and vectors may be used to generate the airway representation. The representation of the airways is typically generated by computer-based image processing—e.g. of the 3D image. The representation of the target site may be generated either by such image processing, by identification by a human (e.g. a physician), and/or by a combination of both.

The generation of the computer model may be performed by a model-generation module—e.g. a data-processing system or a component thereof.

The route planning may be performed by a map-generation module (e.g. a data-processing system or a component thereof) that, utilizing the computer model, generates a map that includes the pair of routes.

The designation of the sites and/or the routes may be based on one or more parameters of input data, which are typically parameters of the lung/airways and/or characteristics of the system to be used. Parameters of the lung/airways may, e.g., be derived from the computer model, and/or may include, e.g., anatomical features in the target vicinity; distances among tool site, imaging site, and target; airway diameters and branching patterns; distance from the trachea to the target along the airways; and size of the target. Characteristics of the system may include, e.g., features of the ultrasound transducer and/or the tool; details of the tube (e.g. catheter) model; and type of system and/or controller. Typically, site and/or route designations are generated by a data-processing system (e.g. running programs and/or algorithms) that uses one or more such parameters as inputs. In an exemplary application, input data may be grouped into two or more clusters of related parameters, e.g., imaging-route parameters, tool-route parameters, and route-pairing parameters. In other applications, input data may be grouped into other clusters, e.g., hardware parameters, operator preferences, subject parameters, target, and 3D imaging information.

Because the imaging and tool sites are typically designated such that the target and the tool will appear in the field of view of the ultrasound transceiver, the imaging and tool sites and/or routes are typically designated as pairs. That is, rather than merely assessing a quality of a given potential imaging site/route in isolation, or a quality of a given potential tool site/route in isolation, the designation techniques/algorithms disclosed herein typically assess these sites/routes as potential pairs—each potential pair including a potential imaging site/route and a potential tool site/route. For example, a potential pair may only be considered suitable if (i) the target and the tool site of the pair are within the effective imaging range of the imaging site, and (ii) both the imaging site and the tool site are accessible by their respective tubes.

In some applications, the system includes a robotic controller (e.g. including a robotic-control module) used to advance the sheath and/or tubes towards their respective sites—e.g. by controlling a robotic manipulator that is couplable to the tubes. The robotic manipulator may be a component of the robotic controller, or may be electronically connectable to the robotic controller.

For some such applications, the computer model of the lung/airways may be used to determine the position of the first and second tubes as they are advanced within the airways, e.g. by mapping, onto the computer model, real-time positioning data—e.g. imaging data generated from ultrasound transceiver(s) and/or camera(s) at the end of the tubes, and/or data (e.g. electromechanical data) from sensors on the tubes and/or the robotic manipulator. Such route tracking may be performed by a route-tracking module (e.g. a data-processing system or a component thereof) that, utilizing the map and the real-time positioning data, tracks the advancement of the tubes along the routes. The imaging and tool sites are typically present in (e.g. pre-entered into) the map, such that the route-tracking module can assess whether the tubes are correctly positioned at their respective sites.

The robotic-control module and the route-tracking module may be components of the same data-processing system (e.g. computer) via which the operator advances the tubes. For example, these modules may both be components of the robotic controller.

In some applications, after positioning the ultrasound transceiver at the imaging site and the tool at the tool site, positioning (e.g. alignment) of the ultrasound transceiver and the tool may be further refined by driving an electromagnetic signal through the tool and sensing the electromagnetic signal via the ultrasound transceiver. The signal may be used to facilitate reduction of the distance between the ultrasound transceiver and the tool. For example, the distance-reduction may be guided by a strength of the signal increasing with reduction of the distance. Reducing the distance may be achieved moving the ultrasound transceiver toward the tool, and/or moving the tool toward the ultrasound transceiver. For some applications, the signal may be observed as interference on the ultrasound image obtained from the ultrasound transceiver. For some applications, a computer-generated estimate of the distance between the ultrasound transceiver and the tool may be generated responsively to the intensity of the signal.

In some applications, the ultrasound transceiver acquires multiple two-dimensional (2D) images of the target and its proximity. These two-dimensional images may be stacked by a data-processing device during the procedure to provide near real-time, updateable 3D image of the target. In applications in which the tool appears in the 2D images, the data-processing device may be configured to refine the 3D image by aligning the 2D images according to a known shape of the tool.

There is therefore provided, in accordance with an application of the present invention, a method for use with a lung of a subject, the method including, a method for use with a lung of a subject, the method including:via a trachea of the subject, advancing an end of a first tube along a first airway route to an imaging site within the lung; and/orvia the trachea of the subject, and independently of advancing the end of the first tube, advancing an end of a second tube along a second airway route to a tool site within the lung.

For some applications, the method further includes, while the first tube remains extended along the first route and the second tube remains extended along the second route:using an imaging device extended from the end of the first tube, imaging (i) a tool extended from the end of the second tube, and (ii) a target within the lung; and/orguided by the imaging of the target and the tool, performing a procedure on the target using the tool.

For some applications:the method further includes advancing a sheath via the trachea toward the lung;advancing the end of the first tube includes extending the first tube out of the sheath; and/oradvancing the end of the second tube includes extending the second tube out of the sheath independently of extending the first tube out of the sheath.

For some applications, the sheath defines a first lumen and a second lumen.

For some applications, advancing the end of the first tube along the first route includes advancing the end of the first tube along the first route while the first tube is extended through the first lumen.

For some applications, advancing the end of the second tube along the second route includes advancing the end of the second tube along the second route while the second tube is extended through the second lumen.

For some applications, advancing the distal part of the sheath includes actively steering the distal part of the sheath using an extracorporeal sheath controller.

For some applications, performing the procedure on the tissue includes performing the procedure while the tissue is disposed between the imaging device and the tool.

For some applications, performing the procedure on the tissue includes performing the procedure while the tool is closer than the tissue to the imaging device.

For some applications, performing the procedure on the tissue includes performing the procedure while the tissue is behind the tool, in a field of view of the imaging device.

For some applications, advancing the first tube along the first route to the imaging site includes advancing the first tube along the first route to the imaging site while the imaging device is disposed at the end of the first tube.

For some applications, advancing the second tube along the second route to the tool site includes advancing the second tube along the second route to the tool site while the tool is disposed at the end of the second tube.

For some applications, the method further includes, subsequently to advancing the end of the first tube to the imaging site, advancing the imaging device through the first tube, and out of the end of the first tube.

For some applications, the method further includes, subsequently to advancing the end of the second tube to the tool site, advancing the tool through the second tube, and out of the end of the second tube.

For some applications, the sheath defines a first lumen and a second lumen, and:advancing the end of the first tube along the first route includes advancing the end of the first tube along the first route while the first tube is extended through the first lumen, andadvancing the end of the second tube along the second route includes advancing the end of the second tube along the second route while the second tube is extended through the second lumen.

For some applications, advancing the distal part of the sheath includes actively steering the distal part of the sheath using an extracorporeal sheath controller.

For some applications, advancing the end of the first tube includes actively steering the first tube using an extracorporeal first-tube controller.

For some applications, advancing the end of the second tube includes actively steering the second tube using an extracorporeal second-tube controller.

For some applications, performing the procedure includes performing the procedure while continuing to image the tissue using the imaging device.

For some applications, imaging the tissue includes acquiring one or more images that include the tool.

For some applications, the imaging device includes an ultrasound transceiver, and imaging the tissue includes imaging the tissue using the ultrasound transceiver.

For some applications, the imaging device is a LIDAR device, and imaging the tissue includes imaging the tissue using the LIDAR device.

For some applications, the tissue is located within a target bronchus of the lung, and advancing the end of the second tube along the second route to the tool site includes advancing the end of the second tube intrabronchially along the second route to the target bronchus.

For some applications:the tool site is within a target bronchus of the lung,the tissue is parenchyma of the lung and situated outside the target bronchus of the lung,advancing the end of the second tube along the second route to the tool site includes advancing the end of the second tube along the second route to the tool site that is within the target bronchus, andperforming the procedure on the tissue using the tool extended from the end of the second tube includes extending the tool, from the end of the second tube, through a wall of the target bronchus and towards the parenchyma.

For some applications:the tool includes a tool element selected from the group consisting of: a needle, a blade, scissors, a suction device, jaws, a grasper, an ablation device, and an energy applicator; andperforming the procedure on the tissue using the tool includes performing the procedure on the tissue using the tool that includes the selected tool element.

For some applications, performing the procedure includes ablating the tissue.

For some applications, performing the procedure includes excising a foreign body from the lung.

For some applications, the procedure is a close-up imaging procedure, the tool is a close-up imaging device, and performing the procedure includes performing the close-up imaging procedure.

For some applications, the procedure is an exploratory procedure, and performing the procedure includes performing the exploratory procedure on the tissue.

For some applications:the tissue is situated outside of an airway of the lung,the tool site is within the airway,advancing the end of the second tube along the second route to the tool site includes advancing the end of the second tube along the second route to the tool site that is within the airway, andperforming the procedure on the tissue using the tool extended from the end of the second tube includes extending the tool through a wall of the airway and into the tissue.

For some applications:performing the procedure on the tissue using the tool extended from the end of the second tube includes performing a first part of the procedure on the tissue using the tool extended from the end of the second tube, andthe method further includes, subsequently to performing the first part of the procedure, and while the end of the first tube remains at the imaging site:withdrawing the imaging device from the first tube;withdrawing the tool from the second tube;subsequently, advancing the tool through the first tube; andsubsequently, performing a second part of the procedure on the tissue using the tool extended from the end of the first tube.

For some applications:the method further includes, subsequently to withdrawing the imaging device from the first tube and the tool from the second tube, and while the end of the second tube remains at the tool site, advancing the imaging device through the second tube, andperforming the second part of the procedure includes performing the second part of the procedure, guided by imaging of the tissue by the imaging device at the end of the second tube.

For some applications, the method further includes extracorporeally imaging the tissue while advancing the end of the first tube, and advancing the end of the first tube includes advancing the end of the first tube guided by the extracorporeal imaging of the tissue.

For some applications, extracorporeally imaging the tissue includes extracorporeally imaging the tissue ultrasonically.

For some applications, extracorporeally imaging the tissue includes extracorporeally imaging the tissue using electromagnetic radiation.

For some applications, extracorporeally imaging the tissue includes extracorporeally imaging the tissue magnetically.

For some applications, performing the procedure includes excising the tissue.

For some applications, excising the tissue includes excising a lesion.

For some applications, excising the tissue includes excising a tumor.

For some applications, excising the tissue includes acquiring a biopsy.

For some applications:the bronchus is a bronchus of a given bronchus generation,at a fork, the bronchus forks distally into a first branch and a second branch, advancing the distal part of the sheath into the bronchus includes advancing the distal part of the sheath into the bronchus, not beyond the fork, andadvancing the end of the first tube along the first route to the imaging site includes advancing the end of the first tube beyond the fork, and via the first branch to the imaging site.

For some applications, advancing the end of the second tube along the second route to the tool site includes advancing the end of the second tube beyond the fork, and via the second branch to the tool site.

For some applications, the imaging site is situated, along the first route, at a different bronchus-generational depth than is the tool site, along the second route.

For some applications, the imaging site is situated, along the first route, at a same bronchus-generational depth as is the tool site, along the second route.

For some applications, advancing the end of at least one tube selected from the group consisting of: the first tube and the second tube, along its respective route, includes advancing the end of the at least one selected tube along its respective route guided by a respective camera disposed at the end of the at least one selected tube.

For some applications, advancing the distal part of the sheath into the bronchus includes advancing the distal part of the sheath into the bronchus guided by the respective camera disposed at the end of the at least one selected tube.

For some applications:advancing the end of the first tube along the first route includes advancing the end of the first tube along the first route, guided by a first camera disposed at the end of the first tube,advancing the end of the second tube along the second route includes advancing the end of the second tube along the second route, guided by a second camera disposed at the end of the second tube, andadvancing the distal part of the sheath into the bronchus includes advancing the distal part of the sheath into the bronchus guided by binocular vision provided by the first camera and the second camera.

For some applications, the method further includes, subsequently to advancing the end of the at least one selected tube, withdrawing the respective camera from the selected tube and out of the subject.

For some applications, performing the procedure on the tissue using the tool extended from the end of the second tube, includes performing the procedure on the tissue using the tool extended from the end of the second tube without withdrawing the respective camera from the selected tube.

For some applications, the respective camera includes a light source.

For some applications, subsequently to (i) advancing the end of the first tube to the imaging site, and (ii) advancing the end of the second tube to the tool site, determining a presence of the tissue and the tool in a field of view of the imaging device.

For some applications, the method further includes, subsequently to determining the presence of the tissue and the tool in the field of view, repositioning the tool with respect to the imaging device and the tissue while retaining the tool in the field of view.

For some applications, the method further includes, subsequently to determining the presence of the tissue and the tool in the field of view, repositioning the imaging device with respect to the tool and the tissue while retaining the tool in the field of view.

There is further provided, in accordance with an application of the present invention, a method for use with a lung of a subject, the method including, via a trachea of the subject, advancing a distal part of a sheath into a bronchus of the lung.

The method may further include, while the distal part of the sheath remains disposed within the bronchus, using imaging derived from an ultrasound transceiver disposed at the distal part of the sheath:guiding a distal part of a first tube out of the distal part of the sheath and along a first route to an imaging site within the lung; and/orguiding a distal part of a second tube out of the distal part of the sheath and along a second route to a tool site within the lung.

The method may further include, while the first tube remains extended along the first route and the second tube remains extended along the second route, guided by imaging derived from an imaging device disposed at the distal part of the first tube, performing a procedure on tissue of the lung using a tool at the distal part of the second tube.

For some applications:at a fork, the bronchus forks distally into a first branch and a second branch,the first route includes the first branch,the second route includes the second branch, and/oradvancing the distal part of the sheath into the bronchus includes advancing the distal part of the sheath into the bronchus not beyond than the fork.

For some applications, the ultrasound transceiver is coupled to the distal part of the sheath, and advancing the distal part of the sheath into the bronchus of the lung includes advancing the distal part of the sheath while the ultrasound transceiver is coupled to the distal part.

For some applications, the ultrasound transceiver has a longer-distance field of view than the imaging device.

For some applications, the imaging device has an effective imaging range, and guiding the distal part of the first tube out of the distal part of the sheath and along the first route to the imaging site within the lung includes:guiding the distal part of the first tube to the imaging site such that the first tube is within the effective imaging range of a target within the lung; and/orguiding the distal part of the second tube to the tool site such that the second tube is within the effective imaging range of the imaging device.

For some applications, further including a third tube, the ultrasound transceiver being disposed at a distal section of the third tube, and the method further includes advancing the third tube to the bronchus of the lung, within the sheath.

For some applications, the method further includes advancing the third tube out of the distal part of the sheath.

For some applications, the ultrasound transceiver is a first ultrasound transceiver, and the imaging device is a second ultrasound transceiver.

For some applications, the first ultrasound transceiver is a lower-frequency transceiver than is the second ultrasound transceiver.

There is further provided, in accordance with an application of the present invention, a method for pre-procedurally planning routes through airways of a lung of a subject toward a target site within the lung.

For some applications, building the map that includes a pair of routes includes building the map such that the imaging route and the tool route converge toward the target.

For some applications, the method further includes building the computer model of the lung.

For some applications, building the computer model of the lung includes: generating the representation of the airways from a 3D image of the lung; and incorporating the target into the model.

For some applications, incorporating the target into the model includes receiving an input indicative of the target location and incorporating the input into the computer model.

For some applications: incorporating the target into the model includes incorporating a user-selected target into the model, and the method further includes, prior to incorporating the target into the model: identifying, from the 3D image, one or more potential targets, prompting a user to select the user-selected target from the one or more potential targets, and receiving a user input indicative of the user-selected target.

For some applications: the method further includes receiving an exit-point input indicative of a preferred exit point, within the computer model, for the tool to exit an airway of the lung toward the target, and building the map includes building the map responsively to the exit-point input.

For some applications, the exit-point input is inputted by a user, and receiving the exit-point input includes receiving the user-inputted exit-point input.

For some applications: the exit-point input includes an exit-point coordinate on the computer model, and building the map includes building the map responsively to the exit-point coordinate.

For some applications: the exit-point input includes an exit direction with respect to the airway, and building the map includes building the map responsively to the exit direction.

For some applications: the method further includes receiving, within the computer model, an exclusion-zone input indicative of an exclusion zone within the lung, and building the map includes building the map such that the tool route and the imaging route avoid the exclusion zone.

For some applications, the exclusion-zone input is computer generated, and receiving the exclusion-zone input includes receiving the computer-generated exclusion-zone input.

For some applications: the exclusion-zone input is indicative of a blood vessel within the lung, and building the map includes building the map such that the tool route and the imaging route avoid the blood vessel.

For some applications: the exclusion-zone input is indicative of a nerve plexus within the lung, and building the map includes building the map such that the tool route and the imaging route avoid the nerve plexus.

For some applications: the exclusion-zone input is indicative of a pleural lining within the lung, and building the map includes building the map such that the tool route and the imaging route avoid the pleural lining.

For some applications: the method further includes receiving a preference input indicative of an operator preference, and building the map includes building the map at least in part responsively to the preference input.

For some applications: the preference input is indicative of a preferred viewing angle for the imaging device, and building the map includes building the map responsively to the preference input indicative of the preferred viewing angle for the imaging device.

For some applications: the preference input is indicative of an upper limit for the length of the tool route, and building the map includes building the map responsively to the preference input indicative of the upper limit.

For some applications: the preference input is indicative of an upper limit for a number of airway bifurcations within the tool route, and building the map includes building the map responsively to the preference input indicative of the upper limit.

For some applications: the preference input is indicative of an upper limit for a sharpness of any turn within the tool route, and building the map includes building the map responsively to the preference input indicative of the upper limit.

For some applications: the preference input is indicative of a preferred intracorporeal proximity of the image device to the tool, and building the map includes building the map responsively to the preference input indicative of the preferred intracorporeal proximity of the image device to the tool.

For some applications: the preference input is indicative of a user weighting between a first factor and a second factor, and building the map includes building the map responsively to the preference input indicative of the user weighting.

For some applications: the first factor is a viewing angle for the imaging device, the second factor is an angle-of-attack for the tool, the user weighting is a weighting between optimizing the viewing angle versus optimizing the angle-of-attack, and building the map includes building the map responsively to the preference input indicative of the user weighting between optimizing the viewing angle versus optimizing the angle-of-attack.

For some applications, the method further includes receiving a hardware input indicative of a hardware parameter, and building the map includes building the map at least in part responsively to the hardware input.

For some applications, the hardware parameter is a model of the imaging device, and building the map includes building the map responsively to the hardware input that is indicative of the model of the imaging device.

For some applications, the tool route is for advancement of the tool to the tool site via a tube, and for advancement of the tube to the tool site, the hardware parameter is a parameter of the tube, and building the map includes building the map responsively to the hardware input that is indicative of the parameter of the tube.

For some applications, the hardware parameter is a model of an extracorporeal controller for controlling advancement of the tube, and building the map includes building the map responsively to the hardware input that is indicative of the model of the extracorporeal controller.

For some applications, the parameter of the tube is a diameter of the tube, and building the map includes building the map responsively to the hardware input that is indicative of the diameter of the tube.

For some applications, the parameter of the tube is a bendability parameter of the tube, and building the map includes building the map responsively to the hardware input that is indicative of the bendability parameter of the tube.

For some applications, the hardware parameter is a parameter of the tool, and building the map includes building the map responsively to the hardware input that is indicative of the parameter of the tool.

For some applications, the parameter of the tool is a flexibility of the tool, and building the map includes building the map responsively to the hardware input that is indicative of the flexibility of the tool.

For some applications, the parameter of the tool is a type of the tool, and building the map includes building the map responsively to the hardware input that is indicative of the type of the tool.

For some applications, the parameter of the tool is a dimension of the tool, and building the map includes building the map responsively to the hardware input that is indicative of the dimension of the tool.

For some applications, the dimension of the tool is a width of the tool, and building the map includes building the map responsively to the hardware input that is indicative of the width of the tool.

The method may further include receiving a computer model of the lung, the model including a target within the lung and a representation of the airways.

The method may further include, using the computer model, building a map that includes: a tool route to a tool site within the computer model of the lung, for advancement of a tool for use at the target, and an imaging route to an imaging site within the computer model of the lung, for advancement of an imaging device, at least a distal portion of the imaging route being distinct from a distal portion of the tool route.

For some applications: the computer model includes a designated preferable angle of approach with respect to the target, generated responsively to receipt of a user input that designates the preferable angle of approach with respect to the target, and building the map includes building the map at least in part responsively to the designated preferable angle of approach with respect to the target.

For some applications: the computer model is derived from pre-procedural imaging of the lung; and receiving the computer model includes receiving the computer model that is derived from the pre-procedural imaging of the lung.

For some applications: the pre-procedural imaging is generated using electromagnetic radiation; and receiving the computer model that is derived from the pre-procedural imaging includes receiving the computer model that is derived from the pre-procedural imaging generated using electromagnetic radiation.

For some applications: the pre-procedural imaging is generated magnetically; and receiving the computer model that is derived from the pre-procedural imaging includes receiving the computer model that is derived from the pre-procedural imaging generated magnetically.

For some applications: the computer model is a schematic representation of airways of the lung; and receiving the computer model includes receiving the computer model that is a schematic representation of airways of the lung.

For some applications: the computer model is an image of the lung; and receiving the computer model includes receiving the computer model that is an image of the lung.

For some applications: the computer model includes a schematic representation of the airways, generated by computer processing of the pre-procedural imaging, and receiving the computer model includes receiving the computer model that includes the schematic representation of the airways.

For some applications, the method further includes generating the schematic representation of the airways by computer processing of the pre-procedural imaging.

For some applications, the computer model includes a schematic representation of the target, and/or receiving the computer model includes receiving the computer model that includes the schematic representation of the target.

For some applications, the method further includes generating the schematic representation of the target by computer processing of the pre-procedural imaging.

For some applications, the method further includes generating the schematic representation of the target responsively to receipt of a user input that designates the target.

For some applications, the computer model includes a designated preferable angle of approach with respect to the target, generated responsively to receipt of a user input that designates the preferable angle of approach with respect to the target, and/or receiving the computer model includes receiving the computer model that includes the designated preferable angle of approach with respect to the target.

For some applications, building the map includes designating at least one site selected from the group consisting of: the imaging site and the tool site, responsively to one or more characteristics of the imaging device.

For some applications, building the map includes designating the selected site responsively to an effective imaging range of the imaging device.

For some applications, building the map includes designating the selected site responsively to a manipulability of the imaging device.

For some applications, building the map includes designating at least one site selected from the group consisting of: the imaging site and the tool site, responsively to one or more characteristics of the tool.

For some applications, building the map includes designating the selected site responsively to an effective operating range of the tool.

For some applications, building the map includes designating the selected site responsively to a manipulability of the tool.

For some applications: the map further includes: a sheath-termination site in a bronchus of the lung, and a sheath route, for advancement of a distal end of a sheath to the sheath-termination site, and building the map includes designating the sheath-termination site within the map.

For some applications, the sheath route is common to both the tool route and the imaging route, and building the map includes designating the sheath route that is common to both the tool route and the imaging route.

For some applications, building the map includes designating, within the map, at least one site selected from the group consisting of: the imaging site and the tool site, by determining a predicted presence of the tool at the tool site, within a predicted field of view of the imaging device at the imaging site.

For some applications, building the map includes designating the selected site responsively to an anticipated field of view of the imaging device at the imaging site.

For some applications, building the map includes designating the selected site responsively to at least one parameter of the group consisting of: (i) a proximity of the imaging site to the tool site, and (ii) a proximity of the tool site to the target.

For some applications, building the map includes designating the selected site responsively to on a presence of structures between the imaging site and the tool site.

For some applications, designating the tool site and the imaging site includes designating the tool site and the imaging site manually.

For some applications, building the map includes designating at least one site selected from the group consisting of: the imaging site and the tool site, responsively to at least one parameter of the group consisting of: (i) ease of access to the imaging site and (ii) ease of access to the tool site.

For some applications, building the map includes designating the selected site responsively to at least one parameter of the group consisting of: (i) ease of navigation of a first tube to the imaging site, for advancement of the imaging device, and (ii) ease of navigation of a second tube to the tool site, for advancement of the tool.

For some applications, designating the tool site includes designating the tool site responsively to a predicted accessibility of the tool to the target from the tool site.

For some applications, the method further includes assessing a potential route selected from the group consisting of: the tool route and the imaging route, by simulating the respective tube being advanced to its respective site, via the respective route.

For some applications, assessing a potential route includes providing the simulating of the respective tube being advanced to its respective site as a virtual tour to a human operator.

For some applications, building the map includes designating at least one site selected from the group consisting of: the imaging site and the tool site, responsively to at least one parameter of the group consisting of: (i) a predicted orientation of the imaging device upon arrival at the imaging site and (ii) a predicted orientation of the medical tool upon arrival at a potential tool site.

For some applications, building the map includes designating the selected site responsively to at least one parameter of the group consisting of: (i) a predicted ability to reorient the imaging device at the imaging site, and (ii) a predicted ability to reorient the tool at the tool site.

For some applications, the step of building the map is performed by a computer processor processing an algorithm.

For some applications, the method further includes procuring a plurality of potential pairs, each pair including (i) a potential imaging site and (ii) a potential tool site, and building the map includes assigning a suitability score to each potential pair of the plurality.

For some applications, for each of the pairs of the plurality, procuring the pair includes selecting the tool site of the pair, and subsequently procuring a plurality of potential imaging sites for the selected tool site of the pair.

For some applications, for each of the pairs of the plurality, procuring the pair includes selecting the imaging site of the pair, and subsequently procuring a plurality of potential tool sites for the selected imaging site of the pair.

For some applications, building the map includes assigning the suitability score using artificial intelligence to calculate the suitability score.

There is further provided, in accordance with an application of the present invention, a method for use with a lung of a subject, the method including, via a trachea of the subject, advancing a distal part of a sheath into a bronchus of the lung, the lung having a first branch downstream of the bronchus and a second branch downstream of the bronchus.

The method may further include, while the distal part of the sheath remains disposed within the bronchus: guiding a distal part of a first tube out of the distal part of the sheath and along the first branch to an imaging site within the lung; and guiding a distal part of a second tube out of the distal part of the sheath and along the second branch to a tool site within the lung.

The method may further include, while the first tube remains extended along the first branch and the second tube remains extended along the second branch, guided by imaging derived from an imaging device disposed at the distal part of the first tube, performing a procedure on tissue of the lung using a tool at the distal part of the second tube.

There is further provided, in accordance with some applications, a data-processing apparatus including means for carrying out the steps of the method.

There is further provided, in accordance with some applications, a computer program including instructions which, when the program is executed by a computer, cause the computer to carry out the method.

There is further provided, in accordance with some applications, a computer-readable medium having stored thereon the computer program.

There is further provided, in accordance with some applications, a method for use with a lung of a subject, the method including: via a trachea of the subject, guiding a distal part of a first tube along a first airway route distal to the trachea to an imaging site within the lung; and guiding a distal part of a second tube along a second airway route distal to the trachea to a target within the lung; and while the first tube remains extended along the first airway route and the second tube remains extended along the second airway route, guided by images derived from an imaging device disposed at the distal part of the first tube, performing a procedure on the target using a tool extending from the distal part of the second tube to the target.

For some applications, the imaging device is an ultrasound transceiver, and performing the procedure includes performing the procedure guided by images acquired by the ultrasound transceiver.

For some applications, the images acquired by the ultrasound transceiver are planar, and performing the procedure includes performing the procedure guided by a 3D representation of the target derived from stacking the planar images.

There is further provided, in accordance with an application of the present invention, a system, for use with a lung of a subject, the system including: an imaging device, transbronchially advanceable to an imaging site within a first airway of the lung; a tool, transbronchially advanceable to a second airway of the lung; and a data processing device, placeable in electronic communication with the imaging device and the tool, and including means for carrying out a method including: using the imaging device at the imaging site, imaging a target within the lung; and responsively to the imaging, providing a visual output that facilitates guidance of the tool, from the second airway, to the target.

For some applications: the system further includes: a first transbronchially-advanceable tube having, at a distal part thereof, a first-tube steerable region; a second transbronchially-advanceable tube having, at a distal part thereof, a second-tube steerable region; and the method further includes: guiding advancement of the first tube along a first airway route to the imaging site; and guiding advancement of the second tube along a second airway route to a tool site within the second airway.

For some applications: imaging the target within the lung includes imaging the target while the imaging device is at a distal end of the first tube within the first airway, and providing the visual output includes providing the visual output while (i) the imaging device remains at the distal end of the first tube within the first airway, and (ii) the tool extends from the second tube while the second tube remains within the second airway.

There is further provided, in accordance with some applications, a data-processing system including means for carrying out the steps of the method.

There is further provided, in accordance with some applications, a computer program including instructions which, when the program is executed by a computer, cause the computer to carry out the steps of the method.

There is further provided, in accordance with some applications, a computer-readable storage medium including instructions which, when executed by a computer, cause the computer to carry out the steps of the method.

There is further provided, in accordance with some applications, a computer-implemented method for use with a lung of a subject, the method including using a robotic manipulator to advance an end of a first tube along a first airway route to an imaging site within the lung; and/or via the trachea of the subject, using the robotic manipulator to advance an end of a second tube along a second airway route to a tool site within the lung.

For some applications, the computer-implemented method further includes, while the first tube remains extended along the first route and the second tube remains extended along the second route: (i) using an imaging device extended by the robotic manipulator from the end of the first tube, imaging a target within the lung; and/or (ii) guided by the imaging of the target, performing a procedure on the target facilitated by the robotic manipulator using a tool extended from the end of the second tube.

There is further provided, in accordance with some applications, a data-processing system including means for instructing a robotic manipulator to carry out the steps of the method.

There is further provided, in accordance with some applications, a computer program including instructions which, when the program is executed by a computer, cause the computer to instruct the robotic manipulator to carry out the method.

There is further provided, in accordance with some applications, a computer-readable medium having stored thereon the computer program.

There is further provided, in accordance with an application of the present invention, a computer-implemented method for use with a tool at a target tissue, including:receiving shape data indicative of a three-dimensional shape of the tool;obtaining an ordered stack of ultrasound images, each of the ultrasound images of the stack including a respective slice of the tool and a respective slice of the target tissue; and/orreferencing the shape data, producing an aligned ordered stack of the ultrasound images by aligning the respective slices of the tool to match, to at least a threshold degree, the three-dimensional shape indicated by the shape data.

For some applications, producing the aligned ordered stack includes producing the aligned ordered stack without reordering the ultrasound images in the stack.

For some applications, steps (b) and (c) are performed iteratively, and the method further includes outputting a video stream derived from the iteratively-produced aligned ordered stack.

For some applications, the ultrasound images are two-dimensional images, and obtaining the stack of ultrasound images includes obtaining a stack of two-dimensional images.

For some applications, aligning the respective slices of the tool is configured to predict a trajectory of the tool within the target tissue.

For some applications, at least a portion of a target appears in the respective slice of the target tissue, and aligning the respective slices of the tool is configured to predict a trajectory of the tool toward the target.

There is further provided, in accordance with an application of the present invention, a computer-implemented method for use with a needle at a target tissue, including receiving a three-dimensional (3D) image including a stack of two-dimensional (2D) images.

For some applications, at least part of the target tissue appears in the 3D image, and/or at least part of the needle appears in the 3D image, such that at least one of the 2D images includes a cross-sectional elliptical slice of the needle.

The method may further include determining an eccentricity of the cross-sectional elliptical slice. The method may further include determining an orientation of the cross-sectional elliptical slice within the 2D image.

The method may further include responsively to the eccentricity and the orientation, determining a vector of the needle within the 3D image and with respect to the target tissue.

For some applications, the method further includes displaying the 3D image, including the target tissue and the vector of the needle.

For some applications, the method further includes: responsively to determining: the eccentricity of the elliptical slice, and the orientation of the elliptical slice, adjusting the vector of the needle with respect to a target within the target tissue.

For some applications:the at least one of the 2D images includes a first 2D image and a second 2D image,the first 2D image includes a first cross-sectional elliptical slice of the needle, the first elliptical slice having a first eccentricity, a first orientation within the 2D image, and a first position within the 2D image, and/orthe second 2D image includes a second cross-sectional elliptical slice of the needle, the second elliptical slice having a second eccentricity, a second orientation within the 2D image, and a second position within the 2D image.

For some applications, determining the eccentricity of the elliptical slice includes determining the first eccentricity, determining the orientation of the elliptical slice within the 2D image includes determining the first orientation, and the method further includes, responsively to the first eccentricity and the first orientation, adjusting the 3D image by adjusting an alignment between the first slice and the second slice.

For some applications, adjusting the 3D image includes adjusting the 3D image responsively to the first eccentricity, the first orientation, the second eccentricity, and the second orientation.

For some applications, adjusting the 3D image includes adjusting the 3D image responsively to the first position and the second position.

There is further provided, in accordance with some applications, a data-processing apparatus including means for carrying out the steps of the method.

There is further provided, in accordance with some applications, a computer program including instructions which, when the program is executed by a computer, cause the computer to carry out the method.

There is further provided, in accordance with some applications, a computer-readable medium having stored thereon the computer program.

There is further provided, in accordance with some applications, a method, including:advancing a tool into a subject, toward a tissue of the subject;driving an electromagnetic signal through the tool;advancing an ultrasound transceiver into the subject; and/orsensing the electromagnetic signal via the ultrasound transceiver.

For some applications, the method further includes reducing a distance between the ultrasound transceiver and the tool guided by a strength of the signal increasing with reduction of the distance.

For some applications, reducing the distance includes moving the ultrasound transceiver toward the tool.

For some applications, reducing the distance includes moving the tool toward the ultrasound transceiver.

For some applications, sensing the electromagnetic signal includes sensing the electromagnetic signal while imaging the tissue with the ultrasound transceiver.

For some applications, sensing the electromagnetic signal includes sensing the electromagnetic signal as interference in an image derived from the ultrasound transceiver.

For some applications, sensing the electromagnetic signal includes sensing the electromagnetic signal intermittently.

For some applications, reducing the distance guided by the strength of the signal includes observing a computer-generated estimate of the distance, the computer-generated estimate being generated responsively to the intensity of the signal.

For some applications, the tool is formed from a metal.

For some applications, the method further includes, subsequently to reducing the distance, performing a procedure on the tissue using the tool.

For some applications, performing the procedure includes performing the procedure while the tool is in a field of view of the ultrasound transceiver.

For some applications, reducing the distance includes reducing the distance at least until the tool appears in the field of view of the ultrasound transceiver.

For some applications, sensing the electromagnetic signal includes sensing the electromagnetic signal while the tool is not in the field of view of the ultrasound transceiver.

This summary is meant to provide some examples and is not intended to be limiting of the scope of the invention in any way. For example, any feature included in an example of this summary is not required by the claims, unless the claims explicitly recite the features. Also, the features, components, steps, concepts, etc. described in examples in this summary and elsewhere in this disclosure can be combined in a variety of ways. Various features and steps as described elsewhere in this disclosure may be included in the examples summarized here.

DETAILED DESCRIPTION

Reference is now made toFIGS.1,2A-2F, and5-12, which are schematic illustrations of an exemplary system100, and techniques for use therewith, for performing a bronchoscopic procedure on a lung55of a subject, in accordance with some applications. Typically, prior to the procedure, a target site to be operated on-hereinbelow referred to as target40—and/or one or more routes to the target are predetermined. For example, this predetermination may be based on and/or facilitated by pre-procedure imaging such as, but not limited to, CT or MRI. However, the procedure may alternatively be performed as part of an exploratory bronchoscopy procedure—e.g. with the routes and/or target40being determined intraoperatively. Examples of targets include tumors, lesions, or foreign objects trapped in the lung. The procedure may involve, for example, performing a biopsy on target40, ablating the target, cauterizing tissue of the target, performing localized chemotherapy on the target, performing localized radiotherapy on the target (such as performing brachytherapy and/or conformal stereotactic radiation therapy), performing cryotherapy to the target, performing an ethanol injection at the target, performing argon plasma coagulation at the target, performing photodynamic therapy at the target, or removing the target.

System100includes a first tube120and a second tube130, and typically also includes a sheath110(e.g. a catheter or a tube) through which tubes120and130may extend. First and second tubes120and130are typically flexible and steerable through the airways of the subject. It is to be noted that the term “steerable” means actively steerable, e.g. in a manner that is controllable from outside of the subject, as opposed to being merely sufficiently flexible to passively bend in response to advancement through the airways.

Sheath110is typically also flexible, and may also be steerable. However, for some applications the sheath may be less flexible and/or less steerable than the tubes (e.g. the sheath may not be steerable and/or may be rigid). Furthermore, for some applications, system100does not comprise sheath110.

Sheath110defines a first lumen122and a second lumen132, through which first tube120and second tube130, respectively, may extend. Alternatively, sheath110may define a single lumen, through which first tube120and second tube130are advanced. For some applications, system100is provided with tubes120and130separate from sheath110, and the tubes are adapted to be advanced through the lumen(s). For some applications, system100is provided with tubes120and130already disposed within the lumen(s).

System100may further include an imaging device, such as an ultrasound transceiver128. It should be noted that other imaging devices could also be used, such as, but not limited to, a LIDAR device, a camera, or a device for performing optical coherence tomography. Ultrasound transceiver128may be at a distal end of a first flexible rod125via which one or more wires may pass in order to provide electronic communication between the ultrasound transceiver and an extracorporeal controller180. As described in more detail hereinbelow, during use of the ultrasound transceiver, rod125typically extends through first tube120, such that the ultrasound transceiver is disposed at a distal end126of the first tube.

For some applications, ultrasound transceiver128may comprise a Radial Endobronchial Ultrasound (R-EBUS) transceiver. The transceiver may be composed of a single transceiver element that can produce a planar image (e.g. a radial and/or disc-like) image, by rotating about its own axis. In some applications, the transceiver element is additionally moved axially in order to acquire a plurality of such disc-like images. It is hypothesized that this plurality of images may provide the user with volumetric information of the lung (e.g. to provide 3D imaging).

For some applications, in order to generate these 3D images from the plurality of planar images taken by the transceiver element, controller180(e.g. an imaging processor thereof) may be supplied with the shape and/or size of tool138, such that the imaging processor can use the known dimensions of the tool as a reference for stacking the two-dimensional images into a 3D image, as further described with reference toFIGS.13A-B.

System100may further include a medical tool138, such as a biopsy tool or a treatment tool. For example, tool138may comprise a tool element such as a needle, a blade, scissors, a suction device, jaws, a grasper, an ablation device (such as a radiofrequency ablation device), an energy applicator, a laser device (e.g. an ND-YAG laser), a cautery device (such as a device capable of performing electrocauterization, e.g. using a monopolar or bipolar technique), a brachytherapy device, a chemotherapy/radiotherapy/cryotherapy delivery device, a biopsy brush or any other suitable tool element known in the art. Medical tool138may be at a distal end of a second flexible rod135via which one or more wires may pass in order to provide electronic communication and/or mechanical communication between the medical tool and extracorporeal controller180. As described in more detail hereinbelow, during use of the medical tool, rod135typically extends through second tube130, such that the medical tool is disposed at a distal end136of the second tube.

For some applications, system100also comprises a first camera121and/or a second camera131. Cameras121and131may each be disposed at a distal end of a respective elongated member123or133(e.g. a flexible rod) which, as described in more detail hereinbelow, allows such that the cameras may be positioned at distal ends of tubes120and130, respectively, during advancement of the tubes through the airways of the lung. Each of cameras121and131may include a light source to facilitate imaging. For some applications, cameras121and131are in (or are placeable in) electronic or optical communication with extracorporeal controller180, e.g. via one or more wires or optical fibers that may extend through elongated member123or133, and/or through tube120or130.

For some applications, rather than using tubes120and130, the features and functions described for these tubes may be conferred onto rods125and135, which may extend directly through the lumen(s) of sheath110. This may be particularly feasible for applications in which cameras121and131are not used. In some such applications, a camera may be disposed through sheath110in parallel with, but distinct from, tubes120and/or130.

FIGS.2A-2F, and5-7illustrate at least some steps of a technique for using system100.FIG.5is a flowchart of at least some steps of a technique400, which is such a technique.FIG.6is a flowchart detailing further steps of a technique400a, which may be considered to be a variant of technique400, and/or may be considered to merely expand on certain details of the technique.FIG.7is a flowchart expanding on certain details of a step430of technique400a, for refining positions of the tool and/or the ultrasound transceiver once the first and second tubes have been positioned.

Sheath110may be advanced through a trachea5of a subject, and into a bronchus of lung55, in the direction of target40(FIG.2A, step410ofFIG.5, and step410aofFIG.6). As is shown inFIG.2A, target40may be located distal (i.e. deeper into the airways, namely, at a further generational-depth with the lung) to the primary and/or secondary bronchi of the lung, for example, it may be at a fourth, fifth, sixth, or higher generation of the bronchi, or in the bronchioles of the lung. The target may even be situated outside of the bronchi or bronchioles, e.g. in the parenchyma. Typically, advancement of sheath110is terminated prior to the sheath reaching target40, such that distal end112of the sheath is proximal (i.e. less deep into the airways) from the target itself. For example, sheath110may be advanced only as far as trachea5, or may be advanced into lung55to, e.g., the third generation of bronchi, whereas the target may be situated at or adjacent to, e.g., a sixth-generation bronchus.

In some applications, sheath110is a relatively inflexible component of the catheter system, e.g., is less flexible than tubes120and130. For some applications, the sheath is advanced only as far as the trachea (i.e. not into a bronchus), and/or may serve as primarily as a guide for the initial advancement of tubes120and130.

It is to be noted that the use of sheath110is optional—e.g. represented by steps410and410ahaving a broken outline.

As is shown inFIGS.2B and2C, first tube120and second tube130are then advanced (e.g. independently of each other) through the airways to the first site and the second site, respectively—e.g. are advanced out of sheath110. InFIG.5, this is represented by step420. First tube120and second tube130are advanced along separate routes127and137—e.g. bifurcating from sheath110and/or branching away from each other as they progress deeper into lung55, e.g., into higher-generation, smaller airways, such that distal end126of first tube120become disposed at a first site20and second tube becomes disposed at a different, second site30. First site20may thus be referred to as an imaging site, and second site30may be referred to as a tool site. The two sites are typically situated in different bronchi or bronchioles with respect to each other. It is possible that first site20and second site30are located in airways that converge toward target40. It is to be noted that, although imaging site20may be defined as the site at which advancement of first tube120ceases (i.e. the end of route127), ultrasound transceiver128may be extended through (e.g. beyond) the imaging site—e.g. further distally along the first airway. Similarly, although tool site30may be defined as the site at which advancement of second tube130ceases (i.e. the end of route137), tool138may be extended through (e.g. beyond) the tool site—e.g. further distally along the second airway and/or into the surrounding tissue toward target40.

Tubes120and130may be advanced simultaneously, or in any order (including a stepwise alternating sequence), towards their respective sites20and30. For example, the end of the first tube may become disposed in a first sixth-generation bronchus, and the end of the second tube may become disposed in a different sixth-generation bronchus. That is, the imaging site may be situated, along the first route, at the same bronchus-generational depth (e.g., seventh generation) as is the tool site, along the second route. Alternatively, the first tube may be advanced to a different generation-depth than the second tube, for example the first tube may be advanced only to a fourth-generation bronchus, with the second tube advanced to a seventh-generation bronchus. That is, the imaging site may be situated, along the first route, at a different bronchus-generational depth than is the tool site, along the second route.

Advancement of the sheath may be terminated at a location in the airways that has been predetermined to be appropriate for advancement of both the first and second tubes—e.g. a location that is common to the first and second routes. (Such determination is described in more detail hereinbelow.) For example, advancement of the sheath may be terminated at or just before a fork17at which routes127and137diverge, or within a bronchus15that is common to both of the routes. The predetermined extent of sheath110advancement may also be determined by limitations specific to each subject, such as a diameter of a bronchus capable of receiving the sheath, which necessarily has a diameter greater than tubes120,130.

It is to be noted that, although routes127and137typically diverge from each other at some point (e.g. at some fork) within the airways, they may subsequently converge as they approach the target. That is, a distal part of first route127may converge with a distal part of second route137.

In some applications, and as shown (e.g., inFIGS.2B-C), first tube120and second tube130are guided towards their respective sites using cameras121and131disposed at their respective distal ends126and136, to provide an operator with a view of the airways. This is represented by steps420a′ and420a″ ofFIG.6, which may be considered variants of step420ofFIG.5. In some such applications, these cameras121and131are additionally used to guide the passage of sheath110down the trachea5and into the bronchus15, e.g. with the tubes120and130disposed within the sheath and the cameras disposed at the distal ends126and136of the tubes. This is shown inFIG.2A, and is represented by optional step410aofFIG.6, which may be considered to be a variant of optional step410ofFIG.5. It is hypothesized that such an approach may advantageously provide stereoscopic vision and its associated advantages, such as redundancy and/or depth information (e.g. by generating disparity maps from the images provided by the two cameras), during advancement of sheath110.

In an application in which cameras121and131are used to direct tubes120and130towards their respective sites20and30, once the tubes are positioned at their respective sites, the cameras may be withdrawn through the tubes and out of the subject (FIG.2D, and steps422′,422″ ofFIG.6). In some applications, and as shown inFIG.2E, at this point ultrasound transceiver128is passed through the first tube and out of the first tube's distal end126(step424′ ofFIG.6), and medical tool138is passed through the second tube, and out of the second tube's distal end136(step424″ ofFIG.6). It should be noted, as indicated by box402inFIG.6, that any/all of steps420a′,422′, and424′ can be performed in parallel, prior to, or subsequently to any/all of steps420a″,422″, and424″. This is represented inFIG.6by steps420a′,420a″,422′,422″,424′, and424″ being bordered by a box402, which may be considered to be a process by which the tubes, the imaging device, and the tool are positioned appropriately to begin the procedure—the procedure itself being represented by step440.

Alternatively, one or both cameras may remain at the distal end of the tubes, and an ultrasound transceiver may be delivered through a working channel (not shown) of the first tube and out of its distal end, and/or a medical tool may similarly be delivered through a working channel (not shown) of the second tube and out of its distal end.

In some applications, the first tube is advanced to the imaging site20with ultrasound transceiver128already disposed at its distal end, and the second tube is advanced to the tool site30with medical tool138already at its distal end. In some such applications, tubes120and130may be elongate members that do not have an open lumen.

For some applications, once tubes120and130are positioned at their respective sites (FIG.2E), the position of the imaging device beyond distal end126of tube120, and/or the position of the tool beyond distal end136of tube130, may require adjustment, as represented by optional step430inFIGS.5and6—e.g. without further advancement, retraction and/or steering of the tubes.FIG.7is a flowchart expanding on certain details of optional position refinement step430, in accordance with some applications, and as further described inFIGS.14A-E.

The operator may use real-time imaging provided by ultrasound transceiver128to facilitate this reposition refinement. For example, once ultrasound transceiver128is at imaging site20and/or at distal end126of tube120, imaging using the ultrasound transceiver may be commenced—e.g. the ultrasound transceiver may be activated (step432). Imaging may be commenced prior to arrival of tool138at tool site30and/or at distal end136of tube130, or may be commenced only once the tool has arrived.

Once imaging has commenced, the operator may determine whether target40and/or medical tool138are satisfactorily in the field of view of the ultrasound transceiver (decision434). If target40and/or medical tool138are not adequately positioned in the field of view of ultrasound transceiver128, the position of the ultrasound transceiver and/or the medical tool may be adjusted by manipulating the appropriate tube and/or rod (step436). As shown, this may be an iterative process.

In some applications, an electromagnetic signal may be driven through tool138in order to assist this process—e.g. to indicate to the operator an appropriate direction in which to move the ultrasound transceiver and/or the tool in order to bring the tool into the field of view. Such electromagnetic assistance is described in more detail with respect toFIG.14A-E.

Once it has been determined that the target and/or the tool are within the field of view, the operator may proceed to perform the procedure, facilitated by continued imaging (step440).

As shown inFIG.2F, once the operator determines that medical tool138is positioned satisfactorily with respect to ultrasound transceiver128and target40, the procedure is carried out, guided by the imaging that is provided by the ultrasound transceiver viewing the tool interacting with the target (step440ofFIGS.5-7). Imaging and tool sites20and30and/or routes127and137thereto are typically pre-procedurally designated so that, during the procedure, target40and medical tool138are in the field of view of ultrasound transceiver128(e.g. to view the tool interacting with the target). For example, imaging site20and tool site30may be chosen such that target40becomes disposed between ultrasound transceiver128and medical tool138—e.g. with the ultrasound transceiver “looking back” or “looking over” at the target and the medical tool. Alternatively, the medical tool may be closer than the target to the ultrasound transceiver—e.g. with the target behind the medical tool, from the perspective of the ultrasound transceiver.

In some applications, subsequently to positioning the ultrasound transceiver128and medical tool138at their respective sites20and30(e.g. subsequently to performing at least some of the procedure with the medical tool at site30), the positions of the ultrasound transceiver and the medical tool are switched. This is typically achieved by the ultrasound transceiver and the medical tool being withdrawn from their respective tubes120and130, and one or both of the ultrasound transceiver and the medical tool being advanced through the other tube—e.g. such that medical tool138becomes positioned at site20and/or ultrasound transceiver128becomes positioned at site30. It is hypothesized that this may advantageously provide ultrasound transceiver128and/or medical tool138with access to target40from a different/additional angle of approach. For example, such a technique may be utilized when performing a biopsy on a target to collect a more representative sample of the target. Similarly, such a technique may be used in other procedures, e.g., to release a far side of the target when removing the target from the lung, or to ablate the far side of the target tissue.

Reference is additionally made toFIG.4. For some applications, in order to image the target from more than a single position during the procedure (e.g. from more than just imaging site20), a series of imaging sites may be planned for the ultrasound transceiver. In some such applications, e.g., as shown inFIG.4, building the map may comprise designating multiple imaging sites and/or imaging routes for ultrasound transceiver128.

For example, routes127a,127b, and127cofFIG.4show the ultrasound transceiver acquiring different perspectives of the target during the procedure. For some such applications, a single imaging route may be designated that includes a series of imaging sites that the transceiver will visit sequentially. In some such applications, each imaging site of the series may be designated by assessing its suitability (including its compatibility with the tool site)—e.g. by assigning a suitability score to that imaging site/tool site pair. Multiple tool sites (e.g. a series of tool sites) may similarly be planned for medical tool138.

FIG.4also illustrates that both the imaging site and the tool site may be situated in the same airway (e.g. in the same bronchus, or both within the trachea), such that the first route and the second route both terminate within the same bronchus or within the trachea. In the illustrated example, the target is assigned reference numeral40a. It is noted that, whileFIG.4shows multiple imaging sites and a tool site in the same airway, having multiple imaging sites is independent of having both imaging site and tool site in the same airway. System100allows an operator to reposition ultrasound transceiver128with respect to target40aand tool138in order to attain a satisfactory field of view of tool138interacting with the target—e.g. responsively to the imaging that has been acquired.FIG.4shows first tube120having been first positioned along a route127a, then along a route127b, before finally being positioned along route127cthat the operator has determined results in a satisfactory positioning of ultrasound transceiver128.

Reference is additionally made toFIGS.8-12, which show exemplary processes, algorithms, and data-processing systems which may be used in some applications of the present disclosure to carry out various steps of methods described and illustrated inFIGS.1-4and diagrammed inFIGS.5-7.

The pre-procedure designation of sites20and30and/or target40and/or routes127and137may be performed manually—e.g. by a physician or operator. However, the designation (e.g. route planning) is typically facilitated and/or processed at least in part by a computer (e.g. by a data-processing system running a computer program that includes appropriate instructions), as further illustrated and described hereinbelow.

In accordance with some applications,FIG.8illustrates a computer-implemented technique300(e.g. a program, or a collection of programs) for pre-procedural designation of sites20and30and/or target40and/or routes127and137. Technique300comprises: (a) a step310in which a computer model304of the airways of a lung of a subject is generated from a 3D image302(e.g. a preoperative image set arranged into a 3D representation) of the lung; and (b) a step320in which model304is utilized in building a map306. Map306may include imaging route127, tool route137, and/or the target. The planning of the routes may be part of step320. Examples of planning of the routes are described hereinbelow with respect toFIGS.10-12.

Image302may comprise x-ray (e.g. CT) data, MRI data, ultrasound data, and/or data from any other imaging modus. For example, image302may be a 3D CT image, a 3D MRI image, etc. Image302may be composed of a set of two-dimensional images. In addition to pre-operative imaging data, other inputs may be used for generating the computer model, as further described hereinbelow.

Although steps310and320are described as being components of the same computer-implemented technique (i.e. technique300), it is to be noted that step310may be performed separately from step320—e.g. at a different time (e.g. days, weeks, or months in advance of step320), by a different data-processing system (e.g. on a different computer), and/or in a different location. For some applications, the computer-implemented designation of the sites and/or the routes is performed by activating/running a module182. Module182may be, or may be run by, a data processing system (or a part thereof). InFIGS.2E-F, module182is schematically shown as being a component of and/or controlled by controller180(e.g. by a data-processing system thereof). However, it is to be understood that module182may be separate from controller180. For example, module182may be provided as a computer program and/or may be run on a computer that is distinct from controller180—e.g. in a separate location. The designation of sites20,30and routes127,137may be facilitated by computer model304.

As described above, computer model304may comprise a representation of the airways and may also comprise an indication or representation of the location of a target, the target being the lesion, tissue, or site toward which the planned bronchoscopic procedure is directed. The representation of the airways may be generated from the 3D image. The representation of the airways is typically incorporated into computer model304(or the computer model is composed based upon the representation of the airways) by computer processing of the initial imaging data.

In some applications, map306comprises a vector representation of the airways, which may then be used to generate imaging route127and tool route137—e.g. as further described inFIGS.10-12. In some applications model-generating step (or program)320generates the routes directly from model304—e.g. without utilizing a vector representation of the airways as an intermediary.

In some applications, as described above, imaging site20and tool site30may be designated on the airway representation (e.g., on the computer model or on the map) prior to generating imaging route127and tool route137. That is, imaging site20and tool site30may be used as inputs for generating the routes. In some applications, imaging and tool sites20,30are generated as part of the route planning process.

For some applications, the representation of target40is incorporated into the computer model by computer processing of the 3D image. For example, the computer processing of the 3D image may recognize target40and responsively (e.g. automatically) define the representation of the target within the model. For some application, the representation of the target site may be incorporated into the computer model by a user (e.g., a physician or an operator) identifying the target site—e.g., as described in more detail hereinbelow. In some such applications, the user may demarcate the boundaries of the target within the computer model, such as by defining the boundaries of the target, or marking a surface area of the target. For some applications, the representation of target40is refined by the user after the computer processing has provided a preliminary identification of the target—e.g. the user may select the representation of the target from a selection of proposed potential targets, and/or may refine the boundaries of a target.

FIG.9is a schematic representation of an implementation in which system100is configured to perform, inter alia, steps of technique300, in accordance with some applications.

As described hereinabove, a model-generation step (or program)310generates model304. Step310may be performed by a module183—e.g. a model-generation module. Model-generation step310utilizes inputs specific to a particular subject and/or a particular procedure. As described hereinabove, one such input is 3D image302. As described elsewhere herein, other such inputs may include data indicative of the target—e.g. inputted by a physician. In some applications, the target data may be a direct input of map generation step (or program)320(e.g. the data may be inputted into module182rather than into module183).

As noted hereinabove, computer model304includes a representation of the airways, and typically also includes the target mapped onto the airway representation.

System100may comprise a route-tracking module184(also shown inFIGS.2E-F) configured to determine, and/or provide to the operator an indication of, whether route(s)127/137are being followed as planned, whether site(s)20/30have been reached, and/or whether adjustments are required. Module184is described in more detail hereinbelow.

System100may comprise a robotic-control module186(also shown inFIGS.2E-F), which may be a component of a robotic controller. Robotic-control module186is used to advance sheath110and/or tubes120and130towards their respective sites, and/or to manipulate (e.g. steer) the tubes at their respective sites. This may be achieved by the robotic controller (e.g. robotic-control module186) controlling a robotic manipulator to which it is electronically and/or mechanically connected. Module186is described in more detail hereinbelow.

As shown inFIG.9, map306(typically including a pair of imaging and tool routes), is utilized by modules184and186—e.g. to facilitate performance of steps420a′ and420a″ ofFIG.6. For example, step320(e.g. module182performing step320) may feed map306(e.g. the routes therein) to modules184and186; and/or one or both of modules184and186may obtain or reference map306from step320(e.g. from module182).

Modules184and186may run simultaneously with each other, and/or may communicate with each other in real-time or near-real-time in order to achieve guided advancement of tubes120and130. For example, and as shown inFIGS.2E-F, modules184and186may be components of controller180.

Each (e.g. any, or all) of modules182,183,184, and186may be a component of system100. For each of modules182,183,184, and186that is a component of system100, the module may or may not be a component of controller180.

In some applications, model generation step310may be performed by a component of system100other than controller180. That is, module183may not be a component of controller180. Instead, an independent data-processing system or program may be utilized. In some applications, module183may be used separately (e.g. at a separate time and/or in a different location) from controller180. For example, model-generation step310may be performed pre-procedurally—e.g. in advance of the subject being admitted to the medical facility for the procedure, either as part of system100or as an independent module for use with system100.

In some applications, route generation step320may be performed by a component of system100other than controller180. That is, module182may not be a component of controller180. Instead, an independent data-processing system or program may be utilized. In some applications, module182may be used separately (e.g. at a separate time and/or in a different location) from controller180and/or from module183. For example, route-generation step320may be performed pre-procedurally—e.g. in advance of the subject being admitted to the medical facility for the procedure, either as part of system100or as an independent module for use with system100.

In some applications, modules184and186are components of controller180. In some applications, module186is a separate unit that may be configured to be operated by controller180and/or system100.

For some applications, system100may provide for the user to input a preferable angle of approach with respect to the target—for the first tube and/or for the second tube. For example, a physician may determine that a particular angle of approach for ultrasound transceiver will be advantageous for imaging, and/or that a particular angle of approach for tool138will be advantageous for sampling and/or treating target40and/or a particular portion thereof. Furthermore, the operator may select a tolerance—e.g., such that a range of angles of approach, within the tolerance, is acceptable. These, and/or other factors or parameters such as those detailed in the following paragraphs, may be utilized by module182as inputs for generating map306(e.g. for determining routes127and137).

A non-exhaustive list of such parameters, which may be manually inputted, or may be derived from and/or calculated using the computer model, comprises:(i) An anticipated field of view of transceiver128(e.g. whether target40and/or medical tool138is anticipated to appear in the field of view).(ii) A proximity of a potential imaging site to a potential tool site.(iii) A proximity of a potential tool site to target40.(iv) The presence of structures in the lung (e.g. large blood vessels), between a potential imaging site and a potential tool site, that may obstruct the field of view of transceiver128.(v) Ease of access to a potential imaging site (i.e. ease of navigation of first tube120to the potential imaging site), such as airway geometry (e.g. diameters and branching angles).(vi) Ease of access to a potential tool site (i.e. ease of navigation of second tube130to the tool site) such as airway geometry (e.g. diameters and branching angles).(vii) A predicted orientation of the ultrasound transceiver at a potential imaging site—e.g. a predicted “natural” orientation of the ultrasound transceiver upon arrival at the potential imaging site, and/or a predicted ability to, at the potential imaging site, reorient the transceiver to obtain a desired field of view.(viii) A predicted orientation of the medical tool at a potential tool site—e.g. a predicted “natural” orientation of the tool upon arrival at the potential tool site, and/or a predicted ability to, at the potential tool site, reorient the tool to obtain a desired position with respect to target40.(ix) Accessibility of the medical tool to the target from a potential tool site.(x) A distance between (1) a potential sheath-termination site and (2) (a) a potential imaging site and/or (b) a potential tool site. Typically, this is a distance between a distal-most airway that is common to both a potential first route and a potential second route. For example, with reference to the example shown inFIG.2C, this may be the distance between (1) bronchus15and (2) (a) site20and/or (b) site30. For some applications, this “distance” may be a straightforward distance along the airway(s). Alternatively or additionally, this “distance” may be a generational-distance, meaning a difference between (1) the generational depth of the potential sheath-termination site, and (2) (a) the generational depth of the potential imaging site and/or (b) the generational depth of the potential tool site. For example, the generational-distance between bronchus15and site20may be 3 (i.e. tube120passes 3 forks on its route from bronchus15to site20).(xi) A predicted angle of approach to target40from a potential imaging site20or tool site30—e.g. its correspondence to a user-inputted preferable angle of approach. For example, a potential site may be assessed by determining possible angles of approach to the target.(xii) The dimensions of the target, e.g., as defined in the medical imaging set, or as determined by a medical professional. In some applications, more than one target may be designated.(xiii) Individual characteristics of the subject: e.g., body-mass index, smoking history, height, weight, gender, age, and past medical history including comorbidities.(xiv) Size, shape, model, and/or bendability (e.g. dependent on factors such as flexibility, radius of curvature, material composition, diameter and thickness) of the tubes.(xv) Size, shape, model, viewing frustum, and other details of the imaging devices (cameras, ultrasound).(xvi) Tool parameters: material composition; specific dimensions, e.g., width; flexibility; and type of tool.(xvii) Maximal allowable route length, route tortuousness, and/or route branches.

For some applications, the designation of the sites and/or routes, and/or the derivation and/or calculation of the above parameters may take into account one or more characteristics of system100—e.g. of ultrasound transceiver128and/or medical tool138. Nonlimiting examples of such characteristics include the field of view of ultrasound transceiver128, the effective operating range of the medical tool from the end of second tube130, the effective imaging range of the ultrasound transceiver (marked as “d” inFIGS.2E and2F), the manipulability (e.g. deflectability and/or rotatability) of each of the ultrasound transceiver and the tool at the end of its respective tube (e.g. via respective rod125and135).

In some applications, the parameters may also or alternatively be divided into other potentially overlapping groups, e.g., as shown inFIGS.9, e.g., those relating to:a) the preoperative imaging set, e.g., CT/MRI, of the lung of the subject—(iv), (v), (vi), (x);b) the target within the lung—(ii), (iii), (v), (vi), (ix), (xii)c) subject parameters related to the individual undergoing the procedure—(xiii);d) hardware parameters relating to, e.g., the controller, the ultrasound, and the tool—(i), (v), (vii), (viii), (ix), (xiv), (xv), (xvi);e) operator preferences—(i), (v), (vi), (x), (xi), (xvii).

FIG.10is a schematic diagram of an exemplary route-planning program320a, which may be considered to be a variant of step/program320, in accordance with some applications. In step322, potential routes along the airways to the target are generated by program320a. This may be performed by referencing model304directly, or by first generating map306(e.g. a vector-based map) and then referencing the map. In step324, pairing parameters (described elsewhere herein) are used to identify, from the potential routes generated in step322, potential pairs of routes for the imaging device (e.g. ultrasound transceiver128) and the tool (e.g. tool138). Some of the potential routes may fit the criteria for both imaging routes and tool routes e.g. such that one potential pair may include a given potential route as an imaging route while another potential pair may include the same potential route as a tool route.

In decision326, the potential pairs are analyzed (e.g. using a cost function) to determine the cost of each potential route pair. Because there may exist a trade-off between optimizing the position of ultrasound transceiver128and optimizing the position of medical tool138, analysis may be used to determine an optimal route pair from a selection of satisfactory pairs. For example, the cost function in this program may take into account total route length, number of turns, angles of turning, maneuverability, and proximity of one route to the other through adjacent airways.

In step328, an optimal route pair (e.g. the route pair with the lowest cost) is designated. It is to be understood that optimizing the tool route may necessitate a less-optimal imaging route, or vice versa. Preferentially favoring optimization of the imaging route over optimization of the tool route, or vice versa, may be made by the operator on a case-by-case basis (e.g. by module182providing an adjustable preference weighting), or may be made by the program considering, e.g., subject parameters. Program320amay be performed by module182or a variant thereof.

In some applications, module182may use algorithms and/or computer processing to provide a human operator with a selection of potential pairs, from which the operator can select a desired pair. In some applications, module182may provide a human operator (e.g. a physician) with the possibility of adjusting the weighting of certain of the parameters, such that the operator can give more weight to one parameter over another parameter. For some such applications, this may be considered biasing of the site/route determination algorithm. For example, the operator may be provided with the possibility to adjust a trade-off between visibility and accessibility—e.g., to allow the algorithm to select a less-optimal tool route in exchange for more-optimal imaging. For example, such a trade-off-adjustment feature may be provided e.g., as a slider on a user interface-, to emphasize the nature of this adjustment as a trade-off.

FIG.11is a schematic diagram of an exemplary route-generation program322a, which may be considered to be a variant or subroutine of step322of step/program320a, in accordance with some applications. In step330, potential routes (e.g. all potential routes) to the target are identified. In step332, from the potential routes, potential imaging routes are identified (e.g. a list of potential imaging routes is generated) by applying imaging-route parameters (described hereinabove) to all potential routes. In step334, from the potential routes, potential imaging routes are identified (e.g. a list of potential tool routes is generated) by applying tool-route parameters (described hereinabove) to all potential routes. While the parameters to be considered for each route may be similar, the acceptable values and/or weightings for the imaging route vs. the tool route may differ. It is possible that one potential route may be identified as both a potential imaging route and as a potential tool route. Program322amay be performed by module182or a variant thereof.

FIG.12is a schematic diagram of an exemplary route-planning program320b, which may be considered to be a variant of step/program320, in accordance with some applications. The sequence of steps shown may be used in combination with those described with reference toFIGS.10and/or11, and/or with the hardware/modules/programs described with reference toFIG.9, and/or as an alternate implementation of the disclosed methods. In some applications, the steps may be re-ordered, some steps may be omitted, or other steps added. A list of potential routes is generated (step340). Utilizing the imaging-route parameters and tool-route parameters, potential imaging routes and potential tool routes are identified (step342). From the potential imaging routes and potential tool routes, potential route pairs (i.e. compatible pairs of imaging routes and tool routes) are identified (step343). The pairs of routes are then analyzed to create a priority-ranked list of route pairs. The priority-ranked list may be based on, for example the pairing parameters listed above, and/or inputted operator preferences e.g. regarding prioritization and/or weighting of particular parameters over others (step344). The final output of program320bis the designation of a single route pair having the best score (step346). Designation of this route pair may be responsive to further inputting of operator preferences. For example, one or more potential route pairs (e.g. in the form of the priority-ranked list) may be displayed, along with an interface that prompts for and/or facilitates inputting and/or adjustment of parameters or preferences. For example, a weighting interface may allow the operator to input and/or adjust the weighting of a given factor, and/or prioritization of one factor over another. Examples of such prioritization include prioritization: between route length and angle of approach; between imaging parameters and tool parameters, and between optimization of imaging route and optimization of tool route. Program320bmay be performed by module182or a variant thereof.

It is noted that the steps and components illustrated inFIGS.8-12show exemplary applications of the disclosed methods; other applications of the described methods may include additional or alternate specific steps.

In the present disclosure, the term data-processing system may refer to, be part of, or include an Application Specific Integrated Circuit (ASIC); a digital, analog, or mixed analog/digital discrete circuit; a digital, analog, or mixed analog/digital integrated circuit; a combinational logic circuit; a field programmable gate array (FPGA); a processor (shared, dedicated, group) that executes code; memory (shared, dedicated, or group) that stores code executed by a processor; other suitable hardware components, such as optical, magnetic, or solid state drives, that provide the described functionality; or a combination of some or all of the above, such as in a system-on-chip. The term code, as used above, may include software, firmware, and/or microcode, and may refer to programs, routines, algorithms, functions, classes, and/or objects. The term shared processor encompasses a single processor that executes some or all code from multiple modules. The term group processor encompasses a processor that, in combination with additional circuitry (e.g. processors), executes some or all code from one or more modules. The term shared memory encompasses a single memory that stores some or all code from multiple modules. The term group memory encompasses a memory that, in combination with additional memories, stores some or all code from one or more modules. The term memory may be subset of the term computer-readable medium. The term computer-readable medium does not encompass transitory electrical and electromagnetic signals propagating through a medium, and may therefore be considered tangible and non-transitory. Non-limiting examples of a non-transitory tangible computer readable medium include nonvolatile memory, volatile memory, magnetic storage, and optical storage.

In some applications, a potential pair comprising a potential imaging site20and a potential tool site30is proposed by module182, which then assesses this potential pair in light of the above-described parameters in order to determine a suitability of this potential pair (e.g. the compatibility of the potential imaging site of the pair with the potential tool site of the pair). For example, a potential pair may only be considered suitable if (i) the target and the tool site of the pair are within the effective imaging range of the imaging site, and (ii) both the imaging site and the tool site are accessible by their respective tubes.

In some applications, and as shown inFIGS.10-12, the above-described determination of suitability is performed by assigning a suitability score to each potential pair. That is, the above-described determination of suitability includes calculating the suitability score. The different parameters may be differentially weighted, such that certain parameters contribute more to the suitability score than others. Once the overall score has been calculated, using the above-mentioned parameters, module182may select (and optionally present) at least one pair of sites with a satisfactory score—e.g. with a suitability score that exceeds a predetermined threshold score. For some applications, the data-processing system may select and/or present a single, optimal pair—e.g. the pair that has the highest threshold score of all of the potential pairs that were scored. Artificial intelligence and/or machine learning may be used to determine the optimal pair of sites, by analyzing the different factors, typically using big data to determine the ideal pair.

It is hypothesized that, at least for some applications, for a given potential pair, it may be advantageous to select the potential imaging site based on a previously-selected tool site (as opposed to selecting the potential tool site based on a previously-selected imaging site), e.g. because there may be fewer suitable tool sites than imaging sites within the lung. Therefore, in some applications, the controller first selects a potential tool site30for medical tool138, typically by assessing the compatibility of the potential site for medical tool138, (e.g. with respect to one or more of the above-mentioned parameters). Once a potential tool site has been selected, the computer model is used to procure a plurality of potential imaging sites for the selected potential tool site, and, using the scoring system described above, to select an appropriate potential imaging site for the selected potential tool site.

In contrast to the above, it is hypothesized that, at least for some applications, for a given potential pair, it may be advantageous to select the potential tool site based on a previously-selected imaging site (as opposed to selecting the potential imaging site based on a previously-selected tool site), e.g. because there may be fewer suitable imaging sites than tool sites within the lung. Therefore, in some applications, the controller first selects a potential imaging site20for ultrasound transceiver128, typically by assessing the compatibility of the potential site for ultrasound transceiver128, (e.g. with respect to one or more of the above-mentioned parameters). Once a potential imaging site has been selected, the computer model is used to procure a plurality of potential tool sites for the selected potential imaging site, and, using the scoring system described above, to select an appropriate potential tool site for the selected potential imaging site.

In some applications, once a pair of sites20and30have been proposed, a virtual representation of ultrasound transceiver128and/or medical tool138at their respective potential sites20and30may be used to assess the potential pair. For example, when assessing the parameters of a potential imaging site20, a representation of ultrasound transceiver128at a potential imaging site20may be provided, in order to give a physician or a computer processor the ability to pre-procedurally determine any of (a) which views of the anatomy (e.g. target40) are obtainable by the transceiver at the potential imaging site, (b) how the transceiver will be dimensioned with respect to the narrow airways at the potential imaging site, and (c) whether the transceiver will be repositionable at the potential imaging site. A similar virtual representation may be simulated for medical tool138at a potential tool site30.

In some applications, one or more of the parameters described hereinabove (e.g. the accessibility of a potential first route127or a potential second route137) is assessed by using the computer model to pre-procedurally simulate one or both of first tube120and second tube130being advanced to sites20and/or30respectively, via the potential route(s). This simulation-facilitated assessment may be performed by the data-processing system—e.g. without human input. Alternatively, the simulation may be presented (e.g. by the data-processing system) as a virtual tour, and the simulation-facilitated assessment is performed by a human operator (e.g. a physician), facilitated by the virtual tour.

For some applications, the above-described techniques may be described as using a computer model of a lung to build a map that includes (i) first route127to imaging site120within the computer model of the lung, for advancement of ultrasound transceiver128, and (ii) second route137to tool site30within the computer model of the lung, for advancement of medical tool138. Typically, at least one of (i) the imaging site and (ii) the tool site is designated based on an expected field of view of the ultrasound transceiver with respect to the medical tool (e.g. a predicted presence, within the field of view, of the medical tool at the tool site).

In some applications, and as noted hereinabove, extracorporeal controller180includes a robotic-control module (e.g. of a robotic controller)186, used to advance sheath110and/or tubes120and130towards their respective sites, and/or to manipulate (e.g. steer) the tubes at their respective sites. A user may be able to use robotic-control module186(e.g. the robotic controller to which the robotic-control module belongs) to control (e.g. actuate) a robotic manipulator, for example using a joystick—e.g. controller180may comprise or be connected to a joystick. Alternatively, the robotic manipulator may be at least partly automatically controlled (e.g. actuated) by controller180, such that at least part of the procedure is executed automatically by controller180.

For some applications, the above-described computer model304of lung55may be used by controller180to determine the position of tube(s)120and130within the airways, e.g. by mapping, onto the computer model, real-time positioning data. Such positioning data may include, for example, imaging data generated from ultrasound transceiver(s)128and/or camera(s)121/131at the end of the tubes, and/or data (e.g. electromechanical data) from sensors on the tubes and/or the robotic manipulator. For example, controller180may comprise control circuitry such as a route-tracking module184(e.g. a data-processing module and/or a computer program), that, using the positioning data, can identify whether route(s)127/137are being followed as planned, whether site(s)20/30have been reached, and/or whether adjustments are required. In some such applications, an electromagnetic navigation system may provide this data, by detecting a locator guide(s) on the tube(s), to determine the(ir) position(s) within lung55.

For some applications in which robotic-control module186is used to advance tubes120and130towards their respective sites20and30, intraprocedural imaging (distinct from that provided by transceiver128and/or cameras121/131) may be utilized, in order to determine or verify the position of the tubes (e.g. the ends of the tubes126,136) within lung55. Such intraprocedural imaging is typically performed using an extracorporeal imaging system, such as a CT system (e.g. cone beam CT) or an MRI system.

For some applications in which such intraprocedural imaging is performed, tubes120and130may be sufficiently long such that extracorporeal controller180can be sufficiently spatially separated from the imaging system. This is hypothesized to be advantageous, for example, for applications in which such intraprocedural imaging is performed using MRI, as it may allow MRI-incompatible components of system100(e.g. controller180and/or robotic-control module186) to be situated outside of the vicinity of the imaging—e.g. in a separate room. It is hypothesized that this is particularly advantageous and feasible for applications in which tubes120and130are robotically controlled.

A further hypothesized advantage provided by robotic control is the potential to allow the operator to temporarily move away during imaging, e.g. to advantageously reduce exposure of the operator to ionizing radiation. For example, the robotic control may allow the operator to temporarily “freeze” a position of the tubes within the lung during the procedure, and then return to the subject while the tubes remain stationary.

Reference is again made toFIGS.3A-C, which are schematic illustrations of an exemplary system200, for guiding the advancement of first and second tubes120and130towards their respective sites20and30, in accordance with some applications. System200typically includes all, or at least some of, the elements described with reference toFIGS.2A-Fand5-12. In some applications, system200may include an additional imaging device250, which may be, e.g., a camera or an ultrasound transceiver (i.e. in addition to ultrasound transceiver128or cameras121and131described hereinabove). Imaging device250may be used to guide the advancement of first tube120and second tube130into lung55. In some applications, imaging device (ultrasound transceiver)250has a longer range than transceiver128. Thus, transceiver250may be referred to as a “longer-range transceiver,” while transceiver128may be referred to as a “shorter-range transceiver”. The longer range of transceiver250may be achieved by it using lower frequency ultrasound than shorter-range transceiver128. In such applications, shorter-range transceiver128may generate finer images than longer-range transceiver250.

In order to obtain a view of tubes120and130advancing to their respective sites within lung55, longer-range transceiver250may be disposed at the distal end of a sheath110a(FIG.3A). For example, longer-range transceiver250may be attached to the distal end of sheath110a. Alternatively or additionally, longer-range transceiver250may be positioned at the end of a third tube (not shown) that is advanced through sheath110a. In some such applications, sheath110amay define an additional lumen for the third tube. Sheath110amay be otherwise structurally and/or functionally identical to sheath110. In some applications, longer-range transceiver250is not advanced through sheath110a, but is advanced into lung55(or at least trachea5) outside of the sheath.

Ultrasound transceiver250is typically used to facilitate guidance of first tube120along first route127to imaging site20(FIG.3B), and/or guidance of second tube130along second route137to tool site (FIG.3C). Ultrasound transceiver250thereby serves as a “third-party” that is used to guide medical tool138into lung55such that it enters the effective imaging range of ultrasound transceiver128(or vice versa). Using ultrasound transceiver250, once the operator is satisfied that first tube120is adequately positioned with respect to second tube130and target40, ultrasound transceiver128can “take over” the imaging, providing the operator with a closer, more detailed view of the target and the medical tool.

It is hypothesized that utilizing a longer-range transceiver to oversee the delivery of tubes120and130to imaging and tool sites20and30may provide the operator with a larger field of view of the lung, and, in contrast, using a shorter-range transceiver to image the target may advantageously provide the operator with better imaging of the vasculature and other small structures of the lung during the procedure itself.

In some applications, transceivers128and250have similar imaging ranges, but the position of transceiver250nonetheless provides the operator with the additional advantageous view that the transceiver128alone cannot provide.

Reference is again made toFIGS.1-7. It is hypothesized that the techniques disclosed herein advantageously allow ultrasound transceiver128to be positioned optimally for viewing the operation of the medical tool138at target40—i.e. allowing both the ultrasound transceiver and the medical tool to obtain independent vantages of the target, facilitated by the ability to independently reposition the first tube and the second tube with respect to each other and with respect to the tissue. It is further hypothesized that these techniques advantageously allow for repositioning of ultrasound transceiver128(e.g. mid-procedure) without undesirably also repositioning tool138. It is similarly hypothesized that these techniques advantageously allow for repositioning of tool138(e.g. mid-procedure) without undesirably also repositioning ultrasound transceiver128.

Existing bronchoscopes that allow for simultaneous use of an ultrasound device and a tool typically have a diameter, along the entire length of the bronchoscope, that is wide enough to accommodate both the ultrasound device and the tool (e.g. side by side) along the entire length of the bronchoscope. This may restrict the depth to which the bronchoscope may be advanced into the lung, due to progressive narrowing of the airways at increased depth. It is hypothesized that the current invention facilitates deeper access into the lung due to the independence of tubes120and130from each other. For example, assigning ultrasound transceiver128its own, independently-steerable tube120allows second tube130to be narrower. This may allow (i) each of the tubes to be advanced deeper into the airways (e.g. into narrower bronchi) than would be possible for a bronchoscope that accommodates both an ultrasound device and a tool along its entire length, and (ii) the ultrasound device and the tool to be advanced and positioned independently of each other-thereby facilitating access to targets that are particularly deep within the lung.

Reference is now made toFIGS.13A-B, which are schematic illustrations of techniques for use with a 3D image in which a tool appears, in accordance with some applications.

FIG.13Aschematically illustrates techniques for adjusting alignment of a set of planar ultrasound images of, e.g., a target tissue, into a 3D image, in accordance with some applications. The alignment adjustment may serve to more accurately orient a tool, e.g., a biopsy needle, toward a target within the 3D composite image. As described hereinabove, ultrasound transceiver128may output a plurality of planar images that can be stacked (e.g. by controller180) into a 3D image—i.e. a composite image.FIG.13Ashows an example in which such a plurality of planar images702(e.g.,702a,702b,702c) are received, and are then initially stacked into an ordered stack704, which may be and/or represent a 3D ultrasound image—e.g. by which the operator is guided when performing procedure440(step710). As described hereinabove, tool138is typically present within the 3D ultrasound image while procedure440is performed. For some applications, a step720may be performed in which the ultrasound image is refined (e.g. may be made more accurate and/or representative of the real world) by utilizing a known shape707(e.g. an outline) of medical tool138, a slice138′ of which appears in each of planar images702. In step720, the alignment of planar images702with respect to each other is adjusted (e.g. in-plane) to produce an aligned ordered stack708in which slices138′ collectively assume (to at least a threshold degree) known shape707within the resulting 3D ultrasound image. By virtue of this alignment adjustment, the tissue that appears within the 3D ultrasound image may advantageously also be more accurately represented. The improved alignment may, for example, advantageously facilitate advancement of tool138to a small target within the tissue.

The adjustment of the alignment of planar images702is typically performed while maintaining the order of the planar images within the stack. The adjustment of the alignment may include in-plane translation (e.g. “sliding”) of one image with respect to an adjacent image—e.g. as shown inFIG.13A. For some applications, the adjustment of the alignment may include in-plane rotation of one image with respect to an adjacent image. For some applications, the adjustment of the alignment may be performed while maintaining the angular disposition between adjacent images (e.g. while maintaining the images parallel with each other). For some applications, the adjustment of the alignment may include adjusting the angular disposition between adjacent images (e.g. deflecting the plane of one image with respect to the plane of an adjacent image). For some applications, the adjustment of the alignment may be performed without adjusting spacing between adjacent images. For some applications, the adjustment of the alignment may include adjusting (e.g. increasing or decreasing) spacing between adjacent images.

There is therefore provided, in accordance with some applications of the present invention, a computer-implemented method for use with a tool (e.g. tool138) at a target tissue. The method includes: (a) receiving shape data indicative of a shape (e.g. 3D shape) of the tool; (b) obtaining an ordered stack of ultrasound images, each of the ultrasound images of the stack including a respective slice of the tool and a respective slice of the target tissue; and (c) referencing the shape data, producing an aligned ordered stack of the ultrasound images by aligning the respective slices of the tool to match, to at least a threshold degree, the shape indicated by the shape data.

FIG.13Bschematically illustrates techniques for determining and/or adjusting a trajectory of a needle (e.g. tool138) within a 3D composite image, such as that which may be generated by ultrasound transceiver128, in accordance with some applications.FIG.13Bshows a stack of planar images702(e.g. images702a,702b,702c, etc.)—i.e. a 3D composite image comprising planar images702. As noted above, this may be the 3D ultrasound image, obtained by ultrasound transceiver128, that is used to facilitate performance of the procedure on the target—e.g. by assisting the physician in guiding tool138. Target40is schematically shown as appearing within the 3D image. At least part of the needle appears in the 3D image, such that at least one of 2D images702includes a cross-sectional slice138′ of the needle. In the particular example ofFIG.13B, it is 2D image702athat includes slice138′—e.g. at an entry point730at which the needle (i.e. a representation thereof) enters the 3D image.

The needle has a known cross-sectional shape. The described example relates to the cross-sectional shape being circular, and thereby slice138′ being elliptical. However, it is to be understood that, at least for some applications, the scope of the technique described is applicable, mutatis mutandis, to needles (or tools more generally) that have other cross-sectional shapes, and their correspondingly shaped slices within 2D images.

FIG.13Bshows three states (A, B, and C). In each state, slice138′ appears in image702a, and is elliptical. However, the eccentricity and orientation of the elliptical slice is dependent on the angle and orientation of the needle with respect to image702a, and thereby with respect to the 3D image. (It is to be noted that this, in turn, may be dependent on the orientation, within the lung, of ultrasound transceiver128with respect to tool138.) In state A, elliptical slice138′ is circular, in state B it has a greater eccentricity than in state A (e.g. is a non-circular ellipse), and in state C it has a similar (e.g. identical) eccentricity as, but a different orientation than, state B. It is to be understood that these three states have been chosen purely for illustrative purposes.

A data-processing system (which may be a component of system100, such as a component or module of controller180) is configured to determine (e.g. calculate) the eccentricity of slice138′ and its orientation within its 2D image, and to responsively determine (e.g. calculate) a vector732of the needle (i.e. its representation) within the 3D image, and thereby with respect to the target tissue that appears in the 3D image. For example, in state A, responsively to determining the circularity (i.e. eccentricity=0) of slice138′, the data-processing system would determine that vector732of the needle is transverse with respect to image702a. Similarly, in state B, responsively to determining the eccentricity (i.e. greater eccentricity) of slice138′, the data-processing system would determine that vector732is at a particular shallower angle with respect to image702a. In state C, responsively to determining that slice138′ has the same eccentricity as state B, but a different orientation with respect to image702a(i.e. a different rotational orientation within the plane of image702a), the data-processing system would determine that vector732is at the same angle, but different orientation, with respect to image702a, as in state B.

Vector732may be considered to be a trajectory of needle138—e.g. through the 3D image and/or through the tissue. For some applications, this trajectory may be a predicted trajectory. For example, should the needle appear only in a subset of images702(e.g. in only image702a), vector732may represent the predicted trajectory of the needle through the 3D image (and thereby through the tissue)—e.g. should the needle be advanced axially in its current position and orientation. The data-processing system (e.g. controller180) may superimpose the predicted trajectory onto the ultrasound image so as to aid the physician to advance the needle in the desired manner—e.g. to target40. For some such applications,FIG.13Bmay therefore be considered to represent such superimpositions—e.g. augmented ultrasound images—for states A, B, and C. Furthermore, for such applications, states A, B, and C may illustrate progressive reorientation of the needle in order to orient the needle appropriately to reach target40. State A may represent an initial state, state B may represent reorientation of the needle to a (shallower) angle that is appropriate for an eventual trajectory to target40, and state C may represent subsequent reorientation of the needle in a sweeping manner that finally orients the trajectory such to pass through target40. It is to be understood that even when states A, B, and C are considered to illustrate such reorientation, they are intended to illustrate how such reorientation is possible, rather than to represent discrete and/or necessary steps in such reorientation. The data-processing system (e.g. controller180) may alternatively or additionally provide a discrete (e.g. quantitative) indication of reorientation required in order to achieve the desired trajectory.

For some applications, the eccentricity and/or orientation of slice138′ (as well as optionally its planar position within its 2D image) may be utilized by the data-processing system (e.g. controller180) in order to refine the 3D ultrasound image. For example, these characteristics may be determined (e.g. calculated) for multiple slices138′ (in respective 2D images), and may be compared in order to determine whether the 2D images in the stack are correctly aligned. For example, from the vector determined from the characteristics of a first slice138′, the characteristics of a second slice (e.g. that of the next image in the stack) may be predicted—e.g. for a straight needle, the eccentricity and orientation of the second slice may be predicted to be identical to those of the first slice, while the planar position of the second slice may be predicted to be offset from that of the first slice according to the vector determined from the first slice. Should the characteristics of the second slice not match the predicted characteristics, the data-processing system may adjust the alignment between the first and second slices in order to cause the characteristics to match the prediction, and thereby to refine the 3D image. For some applications, this may therefore be considered to be a variant of the technique described with reference toFIG.13A.

In some applications, the systems and techniques described with reference toFIGS.13A-Bmay be performed by system100, e.g., controller180thereof, or a separate data-processing system.

Reference is now made toFIGS.14A-Eand15, which are schematic illustrations and a flowchart showing at least some steps of a technique by which an electromagnetic signal is used to facilitate positioning of tool138within a field of view of ultrasound transceiver128, in accordance with some applications.

Tool138may comprise an electrically-conductive material such as, but not limited to, a metal. Nonlimiting examples of such materials include stainless steel, carbon steel, titanium, tantalum, tungsten, platinum, and palladium. For such applications, an electromagnetic signal800may be driven through the tool—e.g. by connecting a signal generator to a proximal end of tool138. This connection may be achieved using a general-purpose electrical clip (e.g. a crocodile clip), and/or tool138may be provided with a dedicated electrical terminal (e.g. at a proximal end of the tool) via which the signal generator may be mechanically and electrically connected.

It has been determined by the inventors that such an electromagnetic signal, appropriately configured, is detectable by ultrasound transceiver128. For example, the electromagnetic signal may cause electrical interference in ultrasound imaging. In some situations such interference may be undesirable—e.g. due to it resulting in “noise” (e.g. “snow”) in the image output by the ultrasound transceiver, thereby degrading the image and reducing its utility. In contrast, the present disclosure includes a technique in which such electromagnetic interference can be advantageously utilized for guidance of the tool and/or the ultrasound transceiver—e.g. by providing information on the proximity of the tool to the ultrasound transducer.

The detection of electromagnetic signal800by ultrasound transceiver128may occur via interaction with electronic components of the ultrasound transceiver and/or the ultrasound tool of which the ultrasound transceiver is a component (e.g. its wiring). For example, the ultrasound tool (e.g. wires that extend proximally from the transceiver component—e.g. the piezoelectric crystal) may electrically conduct the electromagnetic signal from the imaging site to an extracorporcal unit (e.g. an ultrasound processor unit) of the ultrasound tool that is configured to receive and/or display the ultrasound signal. This extracorporeal unit may be controller180, may be a component of controller180, may be connectable to controller180, or may be independent of controller180. Irrespectively, this extracorporeal unit may be a component of system100.

In the example shown inFIGS.14A-E, this electromagnetically-facilitated guidance is performed once ultrasound transceiver128and tool138have arrived at sites20and30a, respectively (e.g. as described with reference toFIG.2E, mutatis mutandis). However, it is to be noted that this guidance may be used at other points in the procedure, and for other procedures, with or without tubes120and130. In some applications, the position refinement may be achieved by moving tube120in addition to or alternatively to advancing ultrasound transceiver128out of tube120.

FIG.15is a flowchart of at least some steps in a technique430afor refinement of the position of ultrasound transceiver128and/or tool138. Technique430amay generally correspond to the technique described with reference toFIGS.14A-E, and moreover may be considered to be a variant of step430(FIGS.5-7). Similarly, a subsection436aof technique430amay be considered to be a variant of repositioning step436described with reference toFIG.7.

FIG.14Ashows a state similar to that shown inFIG.2Eexcept that the position of ultrasound transceiver128at tool site20and/or of tool138at tool site30require refinement in order to acquire visualization of the tool within the field of view of the ultrasound transceiver, represented by the concentric circles surrounding ultrasound transceiver128. An electromagnetic signal800is driven through tool138(FIG.14B;FIG.15step452). The signal causes interference810in the output of ultrasound transceiver128(e.g. is sensed by the ultrasound transceiver as interference;FIG.15step453).

It has been determined by the inventors that the magnitude of interference810diminishes with increased distance from ultrasound transceiver128, and that it is therefore possible to identify that the distance between the ultrasound transceiver and the tool (i.e. the “transceiver-to-tool distance”) is decreasing by identifying that the magnitude of the signal is increasing.

Thus, positioning of the tool can be facilitated and/or guided by monitoring the magnitude of the interference. For example, if the magnitude of the interference increases as tool138is moved, it may be determined that the direction of movement is toward the ultrasound transceiver. Similarly, if the magnitude of the interference increases as ultrasound transceiver is moved, it may be determined that the direction of movement is toward the tool. This technique may therefore be used to bring tool138into the field of view of ultrasound transceiver128.

FIG.14Cshows ultrasound transceiver128having been moved in a direction (FIG.15step454). As shown inFIG.14C, as a result of this movement, the detected interference810has increased. As described hereinabove, this may be indicative of a reduction in the transceiver-to-tool distance—e.g. that the direction of movement was appropriate for reducing the transceiver-to-tool distance. Therefore, responsively to identifying that the interference increased (FIG.15decision455), transceiver128is moved further in the same direction (FIG.14D;FIG.15step456). (Should the interference not have increased, the ultrasound transceiver may be moved in a different direction;FIG.15step457). This process may be repeated iteratively until tool138appears in the field of view of the ultrasound transceiver (decision434), at which point the procedure may be performed (e.g. step440ofFIGS.5-7, and15). Electromagnetic signal800may be turned off prior to performing the procedure (FIG.14E)—e.g. in order to eliminate the interference during performance of the procedure.

AlthoughFIGS.14A-Eshow movement of ultrasound transceiver128toward tool138, as indicated inFIG.15, the tool could alternatively or additionally be moved toward the ultrasound transceiver.

There is therefore provided, in accordance with an application of the present invention, a method comprising advancing a tool into a subject, toward a tissue of the subject; driving an electromagnetic signal through the tool; advancing an ultrasound transceiver into the subject; and sensing the electromagnetic signal via the ultrasound transceiver. The method may further comprise subsequently reducing the transceiver-to-tool distance, guided by a strength of the signal increasing with reduction of the transceiver-to-tool distance. Reducing the transceiver-to-tool distance may comprise moving the ultrasound transceiver toward the tool, and/or moving the tool toward the ultrasound transceiver. The reduction of the transceiver-to-tool distance may be performed by observing a computer-generated estimate of the transceiver-to-tool distance, the computer-generated estimate being generated responsively to the intensity of the signal.

In some applications, some steps ofFIGS.14A-Eand15may be fully or partially automated, e.g., performed by robotic-control module186, and/or implemented with assistance of a data-processing system. In some applications, advancement/retraction of either the ultrasound transceiver and/or the tool may be guided by the robotic-control module in response to input from the electromagnetic interference. In some applications, the strength of interference810may be detected and converted to a numerical value, e.g., transceiver-to-tool distance, by a program run by a data-processing system. The computer program may be used to identify an increase or decrease in the transceiver-to-tool distance by identifying that the magnitude of the signal is increasing. Thus, positioning of the tool can be facilitated and/or guided by a control system monitoring the magnitude of the interference.

The frequency of electromagnetic signal800is typically within the range of radio waves, and may be set to optimize its detection (as interference) by ultrasound transceiver128. For example, the frequency of electromagnetic signal800may be approximately the same as the frequency of the ultrasound waves that ultrasound transceiver is configured to detect (and typically also at which the ultrasound transceiver is configured to emit). For example, the frequency of electromagnetic signal800may be at least 1 MHZ (e.g. at least 5 MHZ, e.g. at least 10 MHZ, such as at least 15 MHZ) and/or no more than 50 MHZ (e.g. no more than 30 MHZ, e.g. no more than 25 MHz, such as no more than 22 MHZ). For some applications the frequency of electromagnetic signal800may be between 18 and 22 MHz, such as approximately 20 MHZ.

In the example shown, interference810appears (e.g. is outputted) as visual interference in the image derived from the ultrasound transceiver. However, the scope of the disclosure includes interference of other kinds, such as auditory interference (e.g. an audible output).

For some applications, controller180may be configured to expressly recognize detection of signal800(e.g. detection of interference810′)—e.g. as distinct from the “true” ultrasound signal. For example, the electromagnetic signal may be configured (e.g. modulated) in a manner that is recognizable by controller180.

Electromagnetic signal800may be applied and/or detected intermittently. For example, the electromagnetic signal may be turned on or off by the operator as needed, e.g. to permit viewing the ultrasound image without interference810. However, the operator may choose to use the electromagnetic signal while imaging the tissue and/or performing the procedure.

Intermittent application and/or detection of signal800may also be used to determine the component of the ultrasound output (e.g. the magnitude of that component) that is attributable specifically to interference810—e.g. as opposed to the component of the ultrasound output that is attributable to true detection of ultrasound. For example, for applications in which the ultrasound output is displayed as an image, a brightness of the image (e.g. the average pixel brightness, or the total image brightness) obtained while electromagnetic signal800is off is subtracted from the brightness of the image obtained while the electromagnetic signal is on. Thus, interference810may be quantified by making reference to a comparable ultrasound image in which interference810is known to be absent.

In some applications, more than merely identifying that the transceiver-to-tool distance is decreasing, controller180may be configured to calculate the actual transceiver-to-tool distance. For example, the transceiver-to-tool distance may be calculated based on quantification of interference810. Alternatively or additionally, the transceiver-to-tool distance may be calculated responsively to the changes in the magnitude of the interference as the tool and/or the ultrasound transceiver is moved by a known distance. For example, the transceiver-to-tool distance may be calculated at least in part by utilizing the inverse square law. Thus, the magnitude of signal800and/or interference810detected may be outputted as a computer-generated estimate of the transceiver-to-tool distance. Such ability to calculate the transceiver-to-tool distance may advantageously facilitate refinement of the position of the tool with respect to the ultrasound transceiver. It is noted that a variety of transceivers and tools may provide the required electromagnetic properties; thus, the signal detection is possible without a discrete or dedicated electromagnetic transmitter or a discrete or dedicated electromagnetic receiver.

For some applications in which the actual transceiver-to-tool distance is calculated (e.g. based on quantification of interference810), the vector along which ultrasound transceiver128is being moved may be determined—e.g. by calculating and comparing the transceiver-to-tool distance at several points along the vector.

The apparatuses and methods described in this disclosure (e.g., generation of the computer model, image processing, generation of the map and/or the airway representations therein, designation of the sites and/or routes, and/or other processing) may be partially or fully implemented by one or more computer programs executed by one or more processors. The computer programs include processor-executable instructions that are stored on at least one non-transitory tangible computer readable medium. The computer programs may also include and/or rely on stored data.

Each of the various systems, devices, apparatuses, etc. in this disclosure can be sterilized (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure they are safe for use with patients, and the methods herein can comprise sterilization of the associated system, device, apparatus, etc. (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.). Furthermore, the scope of the present disclosure includes, for some applications, sterilizing any of the various systems, devices, apparatuses, etc. in this disclosure.

The present invention is not limited to the examples that have been particularly shown and described hereinabove. Rather, the scope of the present invention includes both combinations and subcombinations of the various features described hereinabove, as well as variations and modifications thereof that are not in the prior art, which would occur to persons skilled in the art upon reading the foregoing description. Further, the treatment techniques, methods, steps, etc. described or suggested herein or references incorporated herein can be performed on a living animal or on a non-living simulation, such as on a cadaver, cadaver heart, anthropomorphic ghost, simulator (e.g., with the body parts, tissue, etc. being simulated), etc.