Self-guiding catheter with proximity sensor

Abstract

The present technology relates to a catheter navigation system that includes a catheter that includes a steerable distal tip, the steerable distal tip including a proximity sensor. The system also includes a catheter controller. The catheter controller includes: a processor; and a memory storing instructions that, when executed by the processor, cause the catheter controller to perform operations. The operations may include: receiving a proximity signal generated by the proximity sensor from the catheter; identifying a manipulation target based on the proximity signal; and generating a manipulation signal to manipulate the steerable distal tip towards a manipulation target.

Description

[0001] Cross-references to related applications

[0002] This application claims the benefit of U.S. Provisional Application No. 63 / 492,866, filed March 29, 2023, and U.S. Provisional Application No. 18 / 600,292, filed March 8, 2024, which are incorporated herein by reference in their entirety. Background Technology

[0003] Catheters, inserters, and endoscopes are typically long, flexible instruments that can be inserted into a patient's cavities or endoscopic spaces during medical procedures in various situations to facilitate visualization and / or surgical intervention. Such medical devices can be inserted into a patient's mouth, throat, trachea, esophagus, or other cavities (such as blood vessels). These medical devices (such as catheters) may include a steerable distal tip that can be actively controlled to bend or rotate in a desired direction to navigate through anatomical structures.

[0004] The location and arrangement of airway passages or other cavities or lumens are variable between patients. Therefore, to aid in the navigation of catheters, endoscopes, or implants, external imaging modalities (such as computed tomography (CT) or magnetic resonance imaging (MRI)) can be used to create a model or estimate of the patient's anatomy for the individual patient prior to surgery. Summary of the Invention

[0005] The following outlines certain embodiments commensurate with the scope of the originally claimed subject matter. These embodiments are not intended to limit the scope of this disclosure. In fact, this disclosure may cover a variety of forms that may be similar to or different from the embodiments set forth below.

[0006] In one aspect, this technology relates to a catheter navigation system, the catheter navigation system comprising: a catheter including a steerable distal tip including a proximity sensor; and a catheter controller coupled to the catheter. The catheter controller includes: a processor; and a memory storing instructions that, when executed by the processor, cause the catheter controller to perform operations. The operations include: receiving a proximity signal generated by the proximity sensor from the catheter; identifying a manipulating target based on the proximity signal; and generating a manipulating signal to manipulate the steerable distal tip toward the manipulating target.

[0007] In an example, the proximity sensor includes at least one of an infrared sensor, an acoustic sensor, or a temperature sensor. In another example, the proximity sensor includes at least one proximity receiver positioned at least partially around a circumference of the distal tip. In yet another example, identifying the steering signal is further based on an anatomical model generated by an external imaging modality. In still another example, the steerable distal tip further includes a position sensor, and generating the steering signal is further based on orientation data received from the position sensor. In again another example, identifying the steering target includes providing the proximity signal as input into a trained machine learning (ML) model; and receiving the steering target as output from the ML model. In a further example, the steering target is identified by identifying a feature of a proximity signal characteristic of the lumen and selecting a center of the lumen as the steering target.

[0008] In another aspect, the technology relates to a catheter navigation system, including: a catheter including a steerable distal tip including a proximity sensor; and a catheter controller coupled to the catheter. The catheter controller includes: a processor; and a memory storing instructions that, when executed by the processor, cause the catheter controller to perform operations. The operations include: receiving, from the catheter, a proximity signal generated by the proximity sensor; based on the proximity signal, determining a proximity of the steerable distal tip relative to a lumen wall of a lumen; and based on the determined proximity of the steerable distal tip relative to the lumen wall, generating a steering signal to steer the steerable distal tip away from the lumen wall and toward a center of the lumen.

[0009] In an example, determining the proximity of the steerable distal tip relative to the one or more lumen walls includes determining a first distance of a first side of the distal tip to a first lumen wall; and determining a second distance of a second side of the distal tip to a second lumen wall, wherein the second distance is greater than the first distance; and wherein the steering signal is to steer the distal tip toward the second side of the distal tip. In another example, the operations further include identifying a center of the lumen based on the determined proximity. In yet another example, the steering signal is a first steering signal, and the operations further include: identifying, based on the proximity signal, a bifurcation of a first lumen and a second lumen of a patient; identifying, based on an anatomical model of the patient, the first lumen as providing a path to a navigation target in the anatomical model; and generating a second steering signal to steer the distal tip into the first lumen. In still another example, the proximity sensor includes: a proximity emitter; and at least one proximity receiver positioned at least partially around a circumference of the distal tip.

[0010] In another aspect, the technology relates to a method for navigating a catheter as the catheter is advanced within a lumen. The method includes: receiving, at a catheter controller, a proximity signal from a proximity sensor in a steerable distal tip of the catheter, the proximity sensor being at least one of an infrared sensor, an acoustic sensor, or a temperature sensor; providing the proximity signal to a trained machine learning (ML) model; receiving an output from the ML model in response to the proximity signal; identifying a steering target based on the output from the ML model; and automatically bending the distal tip toward the steering target by the catheter controller.

[0011] In an example, the steering target is a central axis of the lumen. In another example, the lumen is a first lumen, the catheter is positioned at a bifurcation of a second lumen and a third lumen, and the steering target is one of the second lumen or the third lumen.

[0012] In another aspect, the technology relates to a catheter navigation system comprising: a catheter comprising a steerable distal tip comprising a proximity sensor; and a catheter controller coupled to the catheter. The catheter controller comprises: a processor; and a memory storing instructions that, when executed by the processor, cause the catheter controller to perform operations. The operations comprise: receiving, from the catheter, a proximity signal generated by the proximity sensor; based on the proximity signal, detecting an anatomical structure in proximity to the distal tip; and generating a steering signal to steer the steerable distal tip away from the detected anatomical structure. In an example, the anatomical structure is a lumen wall. In another example, the anatomical structure is tissue separating two lumens at an interface.

[0013] Features in one aspect or embodiment can be applied as features in any other aspect or embodiment in any appropriate combination. For example, features of a system, handle, controller, processor, viewing instrument, method, or component can be implemented in one or more other systems, handles, controllers, processors, scopes, methods, or components. BRIEF DESCRIPTION OF DRAWINGS

[0014] The advantages of the disclosed technology can become apparent to one of ordinary skill in the art upon reading the following detailed description in conjunction with the drawings, in which:

[0015] Figure 1 A view of a catheter navigation system including a catheter with a proximity sensor is depicted.

[0016] Figures 2A-2F An example proximity sensor configuration at a distal tip of a catheter is depicted.

[0017] Figure 3 A navigation system with a catheter in a first position is depicted.

[0018] Figure 4 A navigation system with a catheter in a second position is depicted.

[0019] Figures 5A-5B A schematic view of automatically steering a catheter to track alignment with a center of a passageway is depicted.

[0020] Figure 6 A view showing the location of proximity data acquired during steering within a patient’s anatomy is depicted.

[0021] Figure 7 A schematic block diagram of a navigation system is depicted.

[0022] Figure 8 An example method for automatically steering a catheter based on proximity data is depicted.

[0023] Figure 9 Another example method for automatically manipulating a catheter based on proximity data is depicted. DETAILED DESCRIPTION

[0024] Catheters, endoscopes, and introducers are thin, elongated flexible instruments that can be inserted into a body lumen for exploration, imaging, biopsy, or other clinical treatment. While the following description primarily relates to catheters, as used herein, catheter is generally intended to include other types of elongated medical instruments such as endoscopes, introducers, and the like. Catheters can be formed as tubes made of various materials such as silicone, rubber, or plastic, and can range in diameter from a few millimeters to several centimeters depending on their intended use. Catheters generally have a hollow center that allows passage of fluids or gases, and they can be used for a variety of medical purposes such as injecting contrast media into a blood vessel or removing fluid from the lungs.

[0025] Catheters can be navigated into a body lumen such as a patient’s airway, gastrointestinal tract, oral or nasal cavity, or other lumen or opening via pushing a distal tip to a desired location, and in certain embodiments, via active manipulation of the distal tip of the catheter. In percutaneous catheterization procedures, a catheter can also be inserted through the skin into a blood vessel or other internal cavity of the body.

[0026] Advancing a catheter into a patient lumen is typically accomplished via a force transmitted from a proximal portion of the device (outside the patient lumen) that causes the distal tip to advance within the patient lumen. As used herein, “proximal” refers to the direction away from the patient lumen, back toward the handle end of the device, and “distal” refers to the direction forward into the patient lumen, away from the physician or caregiver, toward the probe or tip end of the device. For example, a physician or other caregiver pushes down or forward on a proximal portion of the catheter that is located outside the patient lumen, and the resulting motion is transmitted to the distal tip of the catheter, causing the tip to move forward (distally) within the lumen. Similarly, a pulling force applied by the caregiver at the proximal portion can cause the distal tip to retract or move out of the patient lumen in the opposite (proximal) direction. The catheter or catheter controller can also include steering controls to change the orientation at the distal tip based on operator input, causing the catheter to navigate or point in a desired direction.

[0027] Because the shape or size of a patient lumen is not regular, a catheter insertion procedure can include navigating through unpredictable and tortuous paths to reach a specific point in the anatomy, such as into a branching of the lung. While some catheters, such as endoscopes, can have a camera at the distal tip to provide images as the endoscope is advanced, many other catheters do not have a camera. Unless an additional live or real-time external image source (e.g., x-ray device, fluoroscope, MRI, etc.) is used to track the location of the catheter, the location of such a catheter cannot be known exactly as it is inserted into the body. The necessity of using an external imaging device adds the need for additional large-scale equipment, and the continuous use of ionizing radiation is generally undesirable.

[0028] Even in the example where the catheter includes a distal camera (e.g., an endoscope), it can not be possible to acquire images in some lumens (e.g., smaller blood vessels), and the images alone do not indicate the absolute location of the distal tip in the body. Furthermore, as the catheter is passed through the body, bodily fluids or other tissue, such as mucus, blood, etc., can collect on the distal tip, obscuring the camera’s view.

[0029] Among other things, the technology of the present application addresses the above limitations by incorporating a proximity sensor at the distal tip of the catheter. Some examples of proximity sensors can include infrared sensors, acoustic sensors (e.g., ultrasonic sensors), thermal sensors, etc. Depending on the example, the proximity sensor can be additionally or alternatively combined with a camera. The proximity sensor is able to sense the structure of the lumen or cavity into which the distal end of the catheter is inserted (e.g., lumen wall, bifurcation). The manipulation of the catheter can then be based on tracking the proximity of the distal tip of the catheter to the structure of the lumen. For example, based on the proximity of the distal tip to the lumen wall, the distal tip can be automatically manipulated away from the wall and more towards the center of the lumen. By avoiding the walls of the lumen, the potential for causing harm to the patient can be avoided, and a smoother insertion process can be achieved.

[0030] In addition to manipulating the catheter, the proximity data can also be used to determine the location of the distal tip within the patient’s anatomy. For example, a patient-specific model (e.g., generated by external imaging) or a generic patient model representative of the patient’s anatomy (which can be selected from a set of available models based on patient demographics, size, age, gender, etc.) can be used to help locate the catheter within the patient’s body. As the catheter is advanced within the patient’s body, junctions or intersections of the lumens can be identified based on the proximity data. The locations corresponding to the junctions can then be identified in the anatomical model, and the location of the distal tip of the catheter can be correlated to the corresponding locations in the anatomical model. This identification can be performed in real-time, and a location indicator for the catheter can be generated and presented during the procedure. Additionally, the anatomical model can provide additional navigation information based on which the automatic manipulation of the catheter can be based.

[0031] Figure 1 A view of an elongated instrument navigation system 10 is depicted. The elongated instrument navigation system 10 is described below with respect to an example in which the elongated instrument is a catheter, but it should be understood that the system 10 can be used with other types of elongated instruments.

[0032] The navigation system 10 includes a catheter 30 that is inserted into a body of a patient 40. The catheter 30 can be manually advanced into the patient 40 by a clinician. The catheter 30 includes a distal tip 52 at a distal end of the catheter 30 (e.g., an end of the catheter 30 that is inserted into the patient 40). The distal tip 52 includes a proximity sensor 50, and can also include other types of sensors, such as a position sensor 70 (e.g., an inertial measurement unit (IMU)). The distal tip 52 can be steerable via bending or articulation. Steering of the distal tip 52 can be controlled via various steering systems that cause the distal tip 52 to bend in a desired direction. As one example, bending of the distal tip 52 can be controlled via pull wires that extend along a length of the catheter 30.

[0033] Steering of the distal tip 52 is controlled via a catheter controller 34. A proximal end of the catheter 30 is connected to the catheter controller 34. Steering signals generated by the catheter controller 34 can then be used by steering actuators of the catheter 30 to cause the distal tip 52 to bend in a direction and by an amount indicated by the steering signals. In some examples in which the catheter 30 is inserted into an airway of the patient 40, the catheter controller 34 can be a video laryngoscope.

[0034] In some examples, a clinician operating the catheter 30 holds the handle 44 of the catheter controller 34 with his or her left hand 60 and grasps or pinches the catheter 30 with his or her right hand 62. The operator can move the catheter 30 proximally or distally with the right hand 62.

[0035] The catheter controller 34 can also include a display screen 46 that displays images. The images can be images captured from a camera of the catheter (if present) and / or a camera of the video laryngoscope (in examples in which the catheter controller 34 is a laryngoscope). In embodiments, the display screen 46 is a touch screen, and the operator can input touch inputs on the screen 46 (such as with the operator’s left thumb) to steer the distal end of the catheter 30, such as to cause it to bend right, left, up, or down. In this way, with the present technology, both manual steering of the distal tip 52 (e.g., based on clinician input) and automatic steering of the distal tip 52 are possible. When the catheter 30 is being automatically steered, an automatic steering indicator can also be displayed on the display screen to indicate to the operator that automatic steering is occurring. In some examples, automatic steering can only occur when an automatic steering mode of the catheter controller 34 is activated or selected.

[0036] The example navigation system 10 can also include an anatomic model 12. The anatomic model 12 can be created in a variety of different ways, such as using previously acquired images 18 or anatomic data from a patient. In embodiments, the model 12 is created from external imaging scans of a patient prior to a catheterization procedure. The scans can be CT (computed tomography), MRI (magnetic resonance imaging), x-ray, or other diagnostic or imaging scans. These scans can be used to construct a three-dimensional model of the actual anatomy of the individual patient. For example, computations based on CT scans can be used to construct a three-dimensional model of a patient's airway (e.g., computer-based methods for anatomic segmentation based on CT scans). The resulting three-dimensional model shows the actual unique airway branching of that individual patient, as the airway splits and branches below the left and right bronchi.

[0037] In Figure 1 the anatomic structure of the model 12 is the airway of the patient, but it will be appreciated that other anatomic models can be used in other procedures and contexts, including for example models of vascular structures, bone features, soft tissue, and / or gastrointestinal structures, etc. The anatomic model 12 can be displayed as a simplified model generated from rich image data. That is, the overall display of the anatomic model 12 can be an animated view, a line drawing, a three-dimensional model, or a cross-sectional view of the airway. The anatomic model 12 can be rendered to show the approximate location and size of the lumen (e.g., airway passageway 42) and the surrounding tissue wall (such as the tracheal or bronchial wall). For example, using CT scan data that includes density information, the anatomic model 12 can be generated based on density rules to designate regions of lower density as likely to be open airway passageways, and regions of higher density as likely to be tissue. The airway wall of the anatomic model is rendered based on the tissue regions located at the boundary of the open airway passageways. In such examples, the tissue wall can be designated in the anatomic model 12 with or without fine feature resolution or texture. The anatomic model 12 can be generated or updated by the system 10 as provided herein.

[0038] The anatomic model 12 can be displayed on the display screen 68 as a computer-generated graphic 20 during the catheter procedure. The computer-generated graphic 20 can also include a simulated catheter 24 that tracks the advancement of the real catheter 30 in real time. The simulated catheter 24 is a computer-generated animation that represents the actual catheter 30 as it is being moved within the patient 40.

[0039] The simulated catheter 24 tracks real movement of the catheter 30 in the distal or proximal direction caused by manipulation by the operator and / or changes in orientation mediated by manipulation input by the operator to the catheter controller 34. The graphics controller 14 renders the simulated catheter 24 within the anatomical model 12 and moves the simulated catheter 24 within the model 12 in coordination with movement of the real catheter 30. The position of the simulated catheter 24 within the anatomical model 12 is representative of showing the actual position of the catheter 30 within the patient 40, which can include orientation or pose. Thus, when the operator advances the catheter 30 distally within the patient, the graphics controller 14 adjusts the rendering of the simulated catheter 24 to move the simulated catheter 24 a corresponding distance within the model 12. The simulated simulated catheter 24 24 can be a marker that shows the live real-time movement position of the catheter 30 within the global map of the model 12.

[0040] The real-time position of the catheter 30 is provided based on position data from the position sensor 70 and / or proximity data captured by the proximity sensor 50 located at the distal tip 52. The proximity sensor 50 and the position sensor 70 capture live signals during catheter procedures that are provided to the graphics controller 14 in substantially real-time via communication between the catheter 30 and the controller 14, which can be via the catheter controller 34. In some examples, the functionality of the graphics controller 14 is incorporated into the catheter controller 34.

[0041] As the real position of the distal tip 52 changes, the position sensor 70 generates updated position signals based on movement of the distal tip 52. The proximity sensor 50 also generates proximity data based on the relative position of the distal tip 52 relative to the anatomical structure (e.g., the lumen wall). The proximity data and / or the position data can then be used to manipulate the distal tip 52 of the catheter 30 and / or update the position of the simulated catheter 24 in the model 12. In some examples where the catheter also includes a camera, manipulation of the distal tip 52 and / or rendering of the simulated catheter 24 can also be based on images captured by the camera, as discussed in U.S. Application No. 18 / 050,013 entitled “Endoscope with Automatic Steering” and U.S. Application No. 17 / 719,007 entitled “Endoscope Navigation System with Updating Anatomy Model,” both of which are incorporated by reference in their entirety. If there is a conflict between the discussion in this application and any of these references, the discussion in this application controls.

[0042] However, the anatomical model 12 can not be perfectly aligned with the live patient anatomy. In some examples, this inaccuracy can result in the true anatomy (e.g., airway passageway 42) being slightly offset, stretched, or altered relative to the corresponding location in the model 12. Even a model 12 that is initially properly aligned with the patient 40 can become less accurate over the course of a clinical procedure due to patient movement, positional shifts, or changes in health. Further, the generated model 12 can include inherent inaccuracies in the size, scale, or presence / absence of anatomical features based on resolution limitations of the imaging technology or patient-specific variables that affect image quality. In another example, the inaccuracy in the anatomical model 12 can be based on differences in patient position at the time of scanning versus at the time of performing the catheter procedure. For example, the CT images used to generate the anatomical model 12 can have been taken with the patient’s arm positioned over their head and the patient holding their breath completely. In contrast, patients receiving a catheter procedure can typically be scheduled with their arm at their side and breathing either autonomously or via intubation and mechanical ventilation. This difference in patient position and respiration can result in an associated shift in the location of the airway passageway 42, making the anatomical model 12 at least partially inaccurate. While these inaccuracies can be on the order of millimeters and can only exist within discrete regions of the model 12, this difference can result in difficult maneuvering when the operator uses the anatomical model 12 for navigation.

[0043] As provided herein, the navigation system 10 incorporates real-time signals from the proximity sensor 50 and / or the position sensor 70 to update the anatomical model 12 and / or the location of the simulated catheter 24 within the model. These real-time signals can be used in conjunction with the anatomical model 12 to generate a maneuvering signal for the distal tip of the catheter 30. For example, based on the proximity data, an intersection or bifurcation of two lumens can be identified. The corresponding bifurcation in the anatomical model 12 can then be identified. Based on the end goal or navigation plan, the distal tip 52 of the catheter 30 can be automatically maneuvered into the correct or desired lumen.

[0044] In some examples, the real-time proximity signals and / or position signals can also be used to update and / or confirm portions of the anatomical model 12. By way of example, the update can include correcting a portion of the anatomical model 12, adjusting the scale of the anatomical model 12, altering the relationship between features of the anatomical model 12 (such as stretching or compressing a portion of the model), adjusting the orientation of structures in the model, and / or adjusting the rendering of the simulated catheter 24 within the anatomical model 12. For example, the proximity data can indicate the diameter of a lumen, and this data can be used to adjust or update the anatomical model 12.

[0045] The update can also include redirecting the suggested navigation route from the simulated catheter 24 to the desired navigation target based on the updated anatomical model 12. In embodiments, the rendering of the simulated catheter 24 is updated in the anatomical model 12 without changing the dimensions or characteristics of the model itself. For example, if the anatomical model 12 differs in a particular way from the live patient physiological conditions (such that the actual catheter 30 has reached a particular feature in the patient’s body, but the simulated catheter 24 has not reached the corresponding feature in the model 12), the simulated catheter 24 can be moved within the anatomical model 12 to correspond to the location of the catheter 30 in the patient’s body (such as by moving the simulated catheter 24 within the anatomical model 12 to the feature). In this way, the user is provided with accurate navigation, which can move the simulated catheter 24 to track the live catheter 30 without actually changing the model 12 itself. Thus, in examples, updating the model includes updating the placement, orientation, or movement of the simulated catheter 24 within the anatomical model 12.

[0046] As the catheter 30 is advanced within the airway passage 42, the proximity data acquired from the proximity sensor 50 and / or the position data acquired from the position sensor 70 are used to steer the distal tip 52 of the catheter 30 and / or update the anatomical model 12. Thus, in some examples, the catheter 30 can be advanced into the patient 40 and automatically guided or steered to a final destination within the patient 40. Such steering can include not only maintaining the distal tip 52 within a central portion of the lumen (e.g., to avoid contacting the lumen wall), but the steering can also include navigating through junctions or bifurcations to reach the desired target within the patient 40. In this way, the clinician can only need to continue to advance the catheter 30 into the patient 40, and the automatic steering of the present technology guides the catheter 30 to the navigation target with little clinician input.

[0047] Figures 2A-2F Example proximity sensor configurations at the distal tip 52 of the catheter are depicted. The proximity sensor 50 can be positioned at various locations at the distal tip 52 to provide different sensing capabilities. In some examples, the proximity sensor 50 can be positioned at the end of the distal tip 52, allowing the light or acoustic signals to be emitted primarily in the distal direction from the proximity sensor. In other examples, the proximity sensor 50 can be positioned offset from the end of the distal tip 52 and can be positioned around (or partially around) the distal tip 52. The proximity sensor 50 and the position sensor 70 can be mounted on the same circuit board (e.g., a flexible circuit) and electrically connected to the catheter controller via wires extending through the length of the catheter.

[0048] Figure 2AA side view of an example catheter is depicted, with proximity sensor 50 positioned around or at least partially around a circumference of distal tip 52. By positioning proximity sensor 50 around the circumference, proximity sensor 50 is able to more directly sense the proximity of the outer wall or surface of distal tip 52 relative to the anatomical wall or structure of the lumen. While proximity sensor 50 is positioned around the circumference, proximity sensor 50 does not necessarily have to be on the outer surface of distal tip 52. Rather, proximity sensor 50 can be below (or inside) the outer surface of distal tip 52, and proximity sensor 50 is distributed radially around a central axis of distal tip 52 (extending in a proximal-to-distal direction).

[0049] In some examples, proximity sensor 50 includes a proximity emitter 54 and a proximity receiver 56. Emitter 54 emits light and / or acoustic signals, which are then detected by receiver 56 after the light and / or acoustic signals reflect off (or are otherwise affected by) the patient’s anatomical structure (e.g., lumen wall, interface structure). For example, receiver 56 can be a transducer that converts physical energy of the environment around receiver 56 into electrical signals that can be processed and analyzed as discussed herein.

[0050] For example, where proximity sensor 50 is an infrared sensor, emitter 54 is a light emitter (e.g., a light emitting diode) that emits light in the infrared or near-infrared spectrum. In such infrared examples, receiver 56 is an infrared light receiver, which can be in the form of an infrared image detector and / or one or more photodiodes, photo sensors, etc., that are configured to detect light in the infrared band of infrared light emitted by light emitter 54. When using infrared light, the particular band of emitted infrared light can also be selected based on the particular application. For example, when the catheter procedure is being performed within a blood vessel and distal tip 52 is surrounded by blood, some frequencies can be less likely to be absorbed by the blood itself. In other examples where the catheter is inserted into an airway and distal tip 52 can be covered by mucus, some infrared frequencies can penetrate the mucus better than others. Thus, the infrared frequencies utilized can be selected to produce photons that: (1) penetrate the fluid or material that can cover distal tip 52; and (2) reflect off the anatomical wall of interest (e.g., lumen wall).

[0051] In some examples, the particular frequency of the emitted light can be selected or adjusted via the catheter controller. For example, a particular application or anatomy can be selected such that a corresponding frequency of light is selected and emitted by the emitter 54. This can be accomplished using multiple LEDs each having a corresponding frequency band. When a particular frequency band is selected, the corresponding LED is activated or used to generate light. In other examples, the light frequency of an individual catheter can not be adjusted. Instead, multiple catheters can be provided and adjusted for different anatomies or applications. For example, each different catheter can have different LEDs that emit light in different frequency bands.

[0052] In some examples, the infrared sensor 50 can utilize a structured light pattern to determine depth variations around or in front of the distal tip 52. Alternatively or additionally, time-of-flight (ToF) can be used to determine the depth or distance from the distal tip 52 to the anatomy. In some examples, stereo vision techniques can also be used.

[0053] As another example, the proximity sensor 50 can be an acoustic sensor (e.g., an ultrasonic sensor). In some examples, the acoustic sensor includes an emitter 54 and a receiver 56. For example, the acoustic emitter 54 emits an acoustic pulse and the acoustic receiver 56 detects the acoustic pulse reflected from the anatomy. The time-of-flight from emission to detection of the acoustic wave can then be used to determine the distance of the distal tip to different anatomical structures, such as a lumen wall or an interface structure.

[0054] In other examples, the acoustic sensor can include only an acoustic receiver 56 and not an acoustic emitter 54. In such examples, the rate of fluid (e.g., air, blood) flowing past the acoustic receiver 56 can be detected by the acoustic receiver, which can in fact be a pressure sensor. Because the fluid flow has different properties near the lumen wall as compared to the center of the lumen, the flow rate of the fluid is indicative of proximity to the lumen wall. Thus, using one or more acoustic receivers can be used to determine the proximity of the distal tip 52 to the lumen wall. There is no need to determine the actual rate of the fluid (e.g., distance per time metric). Rather, a relative value related to the fluid flow as measured by the receiver 56 can be measured and retained. Relative differences in this value can then be used to estimate proximity.

[0055] In another example, the proximity sensor 50 can be a temperature sensor or thermal sensor. In such an example, the proximity sensor 50 can include only the proximity receiver 56 and not the proximity transmitter 54. For example, a plurality of temperature sensors (e.g., thermistors, thermocouples, thermopiles, etc.) can be distributed radially around the distal tip 52. The temperature sensors then measure the temperature at their respective locations. The temperature can have some relationship to proximity to the lumen wall. For example, the temperature near the lumen wall can be higher than the temperature at the center of the lumen. Thus, if the temperature detected by a first temperature sensor is higher than the temperature detected by a second temperature sensor, the distal tip 52 can not be positioned within the center of the anatomical lumen (e.g., airway, blood vessel). A steering signal can then be generated to turn the distal tip in the direction of the second temperature sensor (i.e., the temperature sensor with the lower temperature measurement).

[0056] Figure 2B A side view of an example catheter is depicted, with the proximity transmitter 54 positioned near the central axis of the distal tip 52 and the proximity receiver 56 positioned further from the central axis than the proximity transmitter. In such an example, the proximity transmitter 54 is capable of transmitting a signal that travels distally into the lumen, and the receiver 56 is capable of resolving spatial reflections of the transmitted signal in a manner that allows generation of a steering signal directed in the direction of one or more receivers.

[0057] Figures 2C-2F A cross-section of the distal tip 52 along a plane perpendicular to the central axis of the distal tip 52 is depicted. Figure 2C An example distal tip 52 is depicted, with the transmitter 54 and receiver 56 distributed (or radially distributed) around the circumference of the distal tip 52.

[0058] Figure 2D An example distal tip 52 is depicted, with the transmitter 54 near the central axis of the distal tip 52 and the receiver 56 around the circumference of the distal tip 52. The receiver 56 can be a plurality of discrete receivers, and / or otherwise configured to determine spatial signal strength. For example, the receiver 56 can be configured to determine signal strength of reflected signals at different radial locations, which can correspond to discrete pixels or acoustic transducer elements.

[0059] Figure 2E An example distal tip 52 is depicted, including radially distributed receivers 56 but not proximity receivers 54. Similar to the receivers in Figure 2D The receiver 56 can be a plurality of discrete receivers, and / or otherwise configured to determine spatial signal strength, similar to the receivers in

[0060] Figure 2FAn example distal tip 52 is depicted that includes a transmitter 54 and a receiver 56 proximate to a central axis of the distal tip 52. In such an example, the transmitter 54 can transmit a cone of light or sound that reflects off of the anatomy surrounding and / or in front of the distal tip 52. The receiver 56 detects the reflected signals and tracks where the signals are reflected to assign a coordinate or location signal intensity. For example, the receiver 56 can assign a signal intensity to different pixels within the receiver’s field of view. Based on the different signal intensities of the pixels, a steering signal can be generated to steer the distal tip 52.

[0061] Figure 3 is a system view that includes a live view of the anatomical model 12, with a simulated catheter 24 representing the position of the real catheter 30. In Figure 3 the real catheter 30 is positioned at a first region 90a in the patient’s anatomy that corresponds to a region 90b in the model 12.

[0062] The rendering of the simulated catheter 24 within the model 12 can be based on the live proximity data stream and / or the position data stream, and updated in real time. For example, the live data stream can be used to correct any inaccuracies in relative position, and compensate for patient position shifts during the procedure. This correction to the model 12 can be done without relying on patient position sensors within the operating room. The model 12 is updated and synchronized according to actual live proximity data from the catheter 30, regardless of the patient’s orientation in the operating room. Patient movement can be compensated for based on the synchronization between the patient 40 and the model 12, rather than using active external patient sensing devices, such as an electromagnetic sensing mat beneath the patient 40.

[0063] In embodiments, the system 10 can perform an initial registration of the anatomical model 12 to the patient 40 by synchronizing the positions of the simulated catheter 24 and the real catheter 30, such as by registering the simulated catheter 24 at the lips of the model 12 when the real catheter 30 passes the patient’s lips. In examples, the anatomical model 12 is registered at least partially relative to one or more detectable external features of the patient, such as a detected nostril, lip, or shoulder of the patient. The initial registration provides a starting point for rendering the simulated catheter 24 within the model 12 according to the actual position of the catheter 30 within the patient 40.

[0064] When the distal tip 52 of the catheter is in the first region 90a, the lumen extends in a continuous manner (e.g., without branching) according to the model 12. Thus, based on the model 112, the steering instructions for the distal tip can be to continue moving along the central axis of the lumen. The determination that the lumen does not branch at the first region 90a can also be made based on, or confirmed by, proximity data from the proximity sensor 50. For example, the proximity sensor 50 can indicate that, within a certain distance distal of the distal tip 52, no branching of the lumen or other anatomical structures that would indicate an intersection is obstructed.

[0065] In Figure 4 the catheter has been advanced distally, moving the catheter 30 further forward into the patient’s airway, to a second region 110a, toward the intersection or branching of the lumens. In the depicted example, the intersection is the carina 100, which is tissue at the end of the trachea where the trachea divides into the left bronchus 102L and the right bronchus 102R. As Figure 4 The simulated catheter 24 has moved forward within the anatomical model 12 distally toward the carina 100, and is represented as being in the corresponding region 110b of the model 12, as indicated by the anatomical model 12 in

[0066] The updated position of the distal tip 52 can be determined based on proximity data from the proximity sensor 50 and / or position data from the position sensor 70. For example, the forward / distal movement of the distal tip 52 can be measured or estimated based on measurements from the position sensor 70 (e.g., an accelerometer). When the anatomical model 12 can then indicate that an intersection should be present at the current location. The intersection or branching can also or alternatively be detected from proximity data from the proximity sensor 50. For example, a pattern of a bifurcation or intersection can be identified from the proximity data. The anatomical model 12 can then be used to determine which lumen the catheter 30 should travel along at the bifurcation.

[0067] Figures 5A-5B A schematic diagram depicting automatic steering of the distal tip 52 of the catheter to track alignment with the center of the lumen 91. Figure 5A A corresponding change in orientation of the distal tip 52 of the catheter within the lumen 91 due to automatic steering of the distal tip is shown. From Figure 5AStarting from the left, the distal tip 32 is not oriented toward the target (a point on the central axis 94 of the lumen 91). Rather, in this example, the distal end 52 is oriented toward the wall 96 of the lumen 91, rather than straight or generally toward the center (e.g., toward a point along the central axis 94). In this orientation, further distal movement can result in the distal tip 52 colliding with the wall 96 of the passageway, which can impede further distal movement and / or cause harm to the patient. For example, this undesired orientation of the distal end 52 can be caused by the operator inadvertently over-manipulating, the operator intentionally pausing distal movement and manipulating the camera to view the wall 96 or some other portion of the anatomy, or due to a natural curvature of the lumen 91.

[0068] When the distal tip 52 is in this position, the proximity data from the proximity sensor 50 indicates that the distal tip 52 is not aligned with the central axis 94 of the lumen. For example, the proximity sensor 50 can indicate that one side of the distal tip 52 is closer to the lumen wall 96 than the other side of the distal tip 52. As an example, the distance Dl between a first side of the distal tip 52 and the lumen wall 96 can be less than the distance D2 between a second side of the distal tip 52 and the lumen wall 96. An automatic manipulation signal or instruction can then be generated to manipulate the distal tip 52 back toward the central axis 94. For example, the automatic manipulation signal manipulates the distal tip 52 in a direction toward the side having the greatest distance from the lumen wall 96.

[0069] As another example, using the proximity data as input, a feature recognition model identifies the lumen 91 (e.g., via identifying the wall 96 and / or identifying a negative space indicative of the lumen 91), and in embodiments, the catheter controller can estimate the location of the center of the lumen 91. The manipulation controller then generates manipulation instructions to cause the distal end 52 to point to the center of the lumen 91. Executing the manipulation instructions causes the distal end 52 to bend, move, or rotate toward the center. After executing these instructions, the distal end 52 is generally oriented along the central axis 94 and points to a location corresponding to the center of the lumen 91.

[0070] Figure 5B A corresponding change in the orientation of the distal tip 52 of the catheter within the lumen 91 due to the automatic manipulation of the distal tip 52 is similarly depicted. Starting from the left, the distal tip 52 is again not pointing along the central axis 94. In this example, the emitter of the proximity sensor 50 emits a light or acoustic signal 53 distally from the distal tip 52. The reflected light or acoustic signal 53 is then detected by the receiver of the proximity sensor 50. In such an example, the received signal 53 forms the basis of the proximity data. The proximity data can then be used to determine whether the distal tip 52 is pointing toward the target and / or to manipulate the distal tip 52 toward the target.

[0071] Analysis of the proximity data can be performed through a series or rules or heuristics and / or through the use of a trained model. For example, a portion of the detected reflection signal having the weakest signal (e.g., amplitude) can correspond to the center of the lumen 91, as the center of the lumen 91 is the least likely to reflect light or acoustic signals. Accordingly, a steering instruction can be generated to steer the distal tip 52 toward the region in the proximity data having the weakest or lowest amplitude. The determination of the weakest or lowest amplitude can be an average amplitude of a set of locations or pixels in the proximity data. For example, a set of N adjacent pixels or locations having the lowest average amplitude can be considered the center of the lumen 91 and thus the steering target. The gradient of the amplitudes can also be used to determine the steering target in the proximity data. For example, the use of a gradient can be useful for two-dimensional planes where the data noise is relatively large. Alternatively or additionally, the proximity data can be provided into a feature recognition model that identifies the center of the lumen 91.

[0072] The feature recognition model can be a machine learning (ML) or artificial intelligence (AI) model trained using supervised, semi-supervised, or unsupervised approaches. In embodiments, the feature recognition model can be trained using a set of proximity data and associated labels identifying the steering target and / or the center of the lumen 91. Labeling of the training data can be performed manually to generate the training data. This training data is then used to train the ML model along with the associated labels. The feature recognition model can use Haar cascades, histograms of oriented gradients combined with support vector machines (HOG + SVM), or deep learning models (e.g., convolutional neural networks), among other types of ML models. The best performing model that most accurately identifies and correctly labels the lumens in the set of proximity data can be selected.

[0073] The feature recognition can be a two-step process of identifying the actual steering target of a feature. For example, a first model can identify a particular feature (e.g., a lumen). Then, a particular steering target within the feature can be identified or selected through the use of a second model or a set of rules / heuristics. For example, the identified feature can be a lumen, and the steering target can be the center of the lumen. As another example, multiple lumens can be identified at a bifurcation, and the steering target can be the center of one of these lumens.

[0074] In addition to automatically steering the catheter to remain centered within a lumen, the present technology can also assist in steering the distal tip 52 into a particular lumen in a multi-lumen branch. Figure 6Examples of catheter navigation based on landmark identification from proximity data 130 and / or location data are shown. Landmark identification can involve processing proximity data to identify features present in proximity data 130, such as vocal cords, bifurcations / junctions of internal lumens, cardiac features, or other anatomical landmarks. For example, proximity data 130a can be acquired when the catheter is in a position with left bronchial opening 136L and right bronchial opening 136R distal to distal tip 52, but proximity data 130a can still capture the presence of these bronchial openings. Bronchial openings and carina 140 can be identified from rule-based processing of proximity data 130a. For example, carina 140 is at the most proximal bifurcation of the bronchial tree distal to the vocal cords. Based on the registration of distal tip 52 to anatomical model 12, location data can be used to determine the distance distal tip 52 has advanced in the body. Based on this estimate and measurements from the anatomical model, it can be predicted when carina 140 will be encountered. For example, carina 140 can be at the first bifurcation distal to the vocal cords. Proximity data at a bifurcation typically includes two low amplitude regions (indicating greater depth from distal tip 52) separated by a high amplitude region (indicating shallower depth from distal tip 52) connecting the low amplitude regions. One or more ML models can also be used to process proximity data to identify bifurcations or other features.

[0075] Openings or bifurcations 140, 142, 144, 146 within the left and right bronchial passageways can follow similar rule-based identification based on low amplitude regions in proximity data separated by higher amplitude regions. Lumen openings can be specified by low amplitude regions with higher amplitude perimeters. For example, second proximity data 130b can be acquired and processed to identify lumens 140, 142 when distal tip 52 is in left bronchial opening 136L. Similarly, third proximity data 130c can be acquired and processed to identify lumens 144, 146 when distal tip 52 is in right bronchial opening 136R.

[0076] In some examples, the anatomical model can include a navigation target 122, which can be an anatomical point of interest, such as a polyp or a surgical site. Navigation to target 122 can be more easily achieved by using the anatomical model. For example, a clinician viewing the updated model can provide steering input to steer distal tip 52 through the correct lumen leading to navigation target 122 as each bifurcation is reached. In other examples, the steering system can automatically steer distal tip 52 into the correct lumen leading to navigation target 122 as each bifurcation is reached. For example, in the depicted example, distal tip 52 is automatically steered into lumen 136L when it reaches the first bifurcation. Distal tip 52 is then steered into lumen 140 when it reaches the second bifurcation.

[0077] Figure 7 A block diagram of a navigation system 700 is shown. As shown, the system includes a catheter 712, a catheter controller 714, a graphics controller 718, and a separate display 716. The catheter 712 includes a proximity sensor 760 (which can include one or more transmitters and / or receivers), a steering actuator 768 (coupled to a distal steerable tip of the catheter for causing the distal tip to bend or unbend), and a position sensor 756.

[0078] The catheter 712 is connected to the catheter controller 714 by a wired (shown) or wireless connection, which includes a processor 770, a hardware memory 772, a steering controller 774 (such as a motor or other driver for operating the actuator 768), a display screen 724, and a wireless transceiver 776. The catheter controller 714 is connected to the graphics controller 718 by a wired or wireless (shown) connection, which also includes a processor 780, a hardware memory 782, a wireless transceiver 786, and stored anatomical models 734. The graphics controller 718 can be, for example, a laptop or desktop computer running software stored on the memory 782. The graphics controller 718 is connected to the display 716 by a wired or wireless (shown) connection. In embodiments, the display 716 is a hardware display screen that is fixedly or portably mounted in the patient’s environment. In one embodiment, the display 716 can be an augmented reality viewer, such as goggles or glasses, that includes hardware components that superimpose the anatomical models 734 onto the patient.

[0079] In examples, the catheter 712 includes one, two, or more steerable segments that form the distal tip. Each steerable segment can be articulated independently of the other segments. Each steerable segment can bend and flex in three dimensions (not just in a single plane, such as up / down or right / left), to a point in all directions, up to the limits of its range of motion. For example, in embodiments, each segment can bend to 90 degrees in any direction, such that it can move within a hemisphere whose radius is equal to the length of the segment. Each segment is steered by its own actuation system, which includes one or more actuators (such as pull wires with sleeves or other actuators described below) that move to cause the segment to bend into or out of a flexed or bent shape.

[0080] Each articulating segment at the distal end of the catheter is manipulated by a steering system, such as steering controller 774, which operates an actuator coupled to the segment, such as steering actuator 768, to bend or straighten the segment. The steering system can include one or more memory metal components (e.g., memory wire, nitinol wire) that change shape based on electrical input, piezoelectric actuators (such as SQUIGGLE motors from New Scale Technologies, Victor NY), a stretchable sheath (stretchable to release a pre-formed bent component, such as spring steel that resumes its bent shape when released from the sheath), mechanical control wires (pull wires), hydraulic actuators, servo motors, or other means for bending, rotating, or turning a distal end of a catheter or a component at the distal end of a catheter.

[0081] Figure 7 The block diagram also shows the flow of signals between the various devices. In embodiments, catheter 712 sends live proximity signals (from proximity sensor 760) and live position signals (from position sensor 756) to catheter controller 714. Catheter controller 714 can also forward the proximity and position signals to controller 718, such as through wireless transceivers on both devices, and / or through a wired connection and / or intermediate devices.

[0082] Controller 718 receives the proximity and position signals and uses this information to adjust the anatomical model and the rendering of the simulated catheter in the anatomical model. Controller 718 can also generate navigation data that can be provided to catheter controller 714. Steering controller 774 can use the navigation data to steer the catheter toward an identified target in the anatomical model 734. For example, at a bifurcation or junction, the navigation data can be used to steer catheter 712 into a particular lumen leading to the target.

[0083] Position sensor 756 is an electronic component that senses the position and orientation (such as orientation relative to gravity) and / or movement (acceleration) of the distal tip of the catheter. Position sensor 756 contains a sensor or combination of sensors to accomplish this, such as an accelerometer, a magnetometer, and a gyroscope. Position sensor 756 can generate absolute position data or position data relative to a fixed reference point for the distal tip of the catheter. Position sensor 756 can be an inertial measurement unit (IMU). Position sensor 756 detects the static orientation and dynamic movement of the distal tip of the catheter and provides a signal indicative of a change in catheter orientation and / or catheter motion. Position sensor 756 sends this signal to catheter controller 714. Position sensor 756 is located inside the tubular housing of catheter 712. As Figure 1At FIG. 2, in embodiments, the position sensor 756 is located at the very end of the distal tip of the catheter so that the position sensor 756 can capture most of the range of motion of the distal tip and the proximity sensor 760. In embodiments, the position sensor 756 is placed at the distal end of the first steerable section, away from the proximal end of the steerable section, to place the position sensor 756 away from the point of movement.

[0084] In embodiments, the position sensor 756 generates a position signal with coordinates and orientation of the distal tip of the catheter 712. The controller 718 uses this coordinate and orientation information to adjust the anatomy model 734 and the simulated catheter 24. For example, when the real catheter 712 moves 1 mm distally in the patient, the position sensor 756 reports this position change through the position signal. The controller 718 receives the new position coordinates and the simulated catheter 24 moves the same or a proportional amount forward (distally) in the anatomy model 734. The new position is then graphically rendered in the display 716. The data signal from the position sensor 756 can be referred to as an orientation signal, a movement signal, or a position signal.

[0085] The processors (such as 770, 780) can be a chip, a processing chip, a processing board, a chipset, a microprocessor, or similar devices. The controllers 714, 718 and the display 716 can also include user inputs (touch screen, buttons, switches). The controllers 714, 718 can also include a power source (e.g., an on-board battery or a removable battery) to provide power to the controllers, catheter or one or more components of the viewer, and communication circuitry to facilitate wired or wireless communication with other devices. In one embodiment, the communication circuitry can include a transceiver to facilitate handshake communication with a remote medical device or a full screen monitor. The communication circuitry can provide received images in real time to an additional monitor.

[0086] The processors can include one or more application specific integrated circuits (ASICs), one or more general processors, one or more controllers, FPGAs, GPUs, TPUs, one or more programmable circuitries, or any combination thereof. For example, the processors can also include or refer to control circuitry for a display screen. The memory can include volatile memory, such as random access memory (RAM), and / or non-volatile memory, such as read only memory (ROM).

[0087] Figure 8 An example method 800 for automatically steering a catheter based on proximity data is depicted. At operation 802, proximity data is received by a proximity sensor positioned in a distal tip of a catheter. The proximity sensor can include at least one of an infrared sensor, an acoustic sensor, and / or a temperature sensor.

[0088] At operation 804, a steering target is identified. The steering target can be a center or central axis of the lumen, or another lumen at a bifurcation, or other possible anatomical target. The identification of the steering target can be performed in different ways depending on the embodiment. For example, in some examples, operations 806 and 808 can be performed. In other examples, operations 810-814 can be performed. In yet other examples, a combination of operations 806-814 can be performed. In some examples, identifying the steering target can also or alternatively include identifying anatomical structures (e.g., lumen walls, tissue between lumens at an interface) based on the proximity data. The steering target and / or steering signal then steers away from the detected anatomical structures.

[0089] At operation 806, a proximity of the distal tip to the lumen wall is determined. This determination can include determining a distance from a plurality of sides of the distal tip to a proximal wall that is closest to the respective side of the distal tip. For example, the determined distance or proximity to the wall can be measured along a path that is substantially orthogonal to an outer surface of the distal tip. As an example, operation 806 can include determining a first distance of a first side of the distal tip to a first lumen wall (e.g., a first portion of the lumen wall that is closest to the first side), and determining a second distance of a second side of the distal tip to a second lumen wall (e.g., a portion of the lumen wall that is closest to the second side).

[0090] At operation 808, the steering target is determined to be toward the side that is farthest from the lumen wall. For example, if all sides of the distal tip are equidistant from the lumen wall, the distal tip can be centered within the lumen, which can be a purpose or goal of the automated navigation or steering of the catheter. Thus, by steering the catheter toward the side that is farthest from the lumen wall, the distal tip will begin to turn toward the center of the lumen.

[0091] At operation 810, the proximity signal is provided as input into a trained ML model. The ML model can be a feature identification model that identifies features within the proximity data. For example, the feature identification model identifies anatomical features, such as lumens, in the proximity data. The feature identification model can identify features by identifying patterns within the proximity data. For example, a low amplitude portion of the proximity data surrounded by a high amplitude portion can indicate a lumen, where the low amplitude portion corresponds to a center of the lumen. At operation 812, an output is received from the ML model in response to the input of the proximity signal. In some examples, the output includes an identification of the steering target. In other examples, the output includes only an identification of one or more features, such as lumens. At operation 814, the steering target is identified based on the output of the ML model. In the case where a lumen is identified as a feature, a center or approximate center of the lumen can be identified as the steering target.

[0092] In some cases, multiple features are identified in the output from the ML model. For example, the feature identification model can identify a channel branch as at least two possible forward lumens. As a result, operation 814 can include selecting one of the features as a manipulation target. The selection of a particular feature of the multiple features can be based on the patient’s anatomical model, as discussed herein and further below. Figure 9

[0093] At operation 816, a position signal is received from a position sensor in the distal tip of the catheter. The position signal can provide information of the orientation (e.g., roll) of the catheter, as well as information about movement of the catheter in distal or proximal directions. At operation 818, it can be determined whether the distal tip of the catheter is oriented toward the manipulation target. The orientation of the distal tip can also or alternatively be determined based on the proximity data. In the case that the orientation of the distal tip is not pointing toward the manipulation target, a difference between the current orientation of the distal tip and an orientation needed to orient the distal tip toward the manipulation target can be determined. The difference can include direction and / or magnitude.

[0094] At operation 820, manipulation instructions are generated that, when executed, cause the distal tip to be oriented toward the manipulation target. The manipulation instructions can be based on the difference between the current orientation and the target orientation determined in operation 818. For example, the manipulation instructions can include both a direction for bending the distal tip and a magnitude by which the distal tip should be bent. At operation 822, the distal end is automatically manipulated (e.g., bent) based on the manipulation instructions. Then, as the catheter continues to be advanced within the patient, the method 800 can be repeatedly executed using new proximity data.

[0095] Figure 9 Another example method 900 for automatically manipulating a catheter based on proximity data is depicted. At operation 902, a proximity signal is received from a proximity sensor in a distal tip of a catheter. A position signal can also be received from a position sensor in the distal tip of the catheter.

[0096] At operation 904, a junction where a bifurcation into at least two lumens (e.g., a first lumen and a second lumen) is detected based on the proximity data. Such a bifurcation can be determined based on pattern recognition or feature recognition using an ML model as discussed above.

[0097] At operation 906, a location of the distal tip within an anatomical model of the patient is determined. The location of the distal tip within the anatomical model can be based on the position signal and an initial registration of the catheter location to the anatomical model. The anatomical model can also include a final navigation target within the patient.

[0098] ​At operation 908, the lumen at the bifurcation (e.g., the first lumen or the second lumen) is identified as the steering target. In some examples, the center of the selected lumen is identified as the steering target. The selection of the lumen can be based on the anatomical model, the current position of the distal tip in the anatomical model, and the location of the navigation target in the anatomical model. For example, the lumen that directs the catheter from its current position to the navigation target is the selected lumen. At operation 910, steering instructions are generated to steer the distal tip toward the steering target, and at operation 912, the distal tip is steered according to the steering instructions. The generation of the steering instructions can also take into account the current orientation of the distal tip, such as discussed above with respect to operations 816-818 of method 800.

[0099] While the present technology is primarily discussed in the context of catheter navigation within airway passages, it should be understood that the disclosed technology can also be used in connection with other types of airway management or clinical procedures. For example, the disclosed technology can be used in connection with placement of other devices within the airway, airway secretion removal, arthroscopic surgery, trans- vocal cord bronchoscopic visualization (bronchoscopy), tube replacement, lung biopsy, nasal or nasotracheal intubation, vascular catheterization procedures, etc. The disclosed catheters can also be used for or in connection with visualization of tissue for aspiration, drug delivery, ablation, or other treatment, and can also be used in connection with endoscopes, stylets, introducers, scopes, or probes. Further, the disclosed technology can also be applied to navigation and / or patient visualization using other clinical techniques and / or instruments, such as patient catheterization techniques. By way of example, contemplated techniques include cystoscopy, cardiac catheterization, catheter ablation, catheter drug delivery, or catheter-based minimally invasive surgery.

[0100] While the present disclosure can allow for various modifications and alternative forms, specific embodiments thereof have been shown by way of example in the drawings and have been described in detail herein. However, it should be understood that the embodiments provided herein are not intended to be limited to the particular forms disclosed. Rather, this disclosure provides for a variety of embodiments, all falling within the spirit and scope of the disclosure as defined by the appended claims.

Claims

1. A catheter navigation system, comprising: a catheter including a steerable distal tip including a proximity sensor; and a catheter controller coupled to the catheter, the catheter controller including: a processor; and a memory storing instructions that, when executed by the processor, cause the catheter controller to perform operations including: receiving, from the catheter, a proximity signal generated by the proximity sensor; identifying a steering target based on the proximity signal; and generating a steering signal to steer the steerable distal tip toward the steering target.

2. The catheter navigation system of claim 1, wherein, The proximity sensor includes at least one of an infrared sensor, an acoustic sensor, or a temperature sensor.

3. The catheter navigation system of claim 1, wherein, The proximity sensor includes at least one proximity receiver positioned at least partially around a circumference of the distal tip.

4. The catheter navigation system of claim 1, wherein, Identifying the steering signal is further based on an anatomical model generated by an external imaging modality.

5. The catheter navigation system of claim 1, wherein, The steerable distal tip further includes a position sensor, and generating the steering signal is further based on orientation data received from the position sensor.

6. The catheter navigation system of claim 1, wherein, Identifying the steering target includes: providing the proximity signal as input into a trained machine learning (ML) model; and receiving the steering target as output from the ML model.

7. The catheter navigation system of claim 1, wherein, The steering target is identified by identifying a feature of a proximity signal characteristic of a lumen and selecting a center of the lumen as the steering target.

8. A catheter navigation system, comprising: a catheter including a steerable distal tip including a proximity sensor; and a catheter controller coupled to the catheter, the catheter controller including: a processor; and a memory storing instructions that, when executed by the processor, cause the catheter controller to perform operations including: receiving, from the catheter, a proximity signal generated by the proximity sensor; determining, based on the proximity signal, a proximity of the steerable distal tip relative to a lumen wall of a lumen; and generating a steering signal to steer the steerable distal tip away from the lumen wall and toward a center of the lumen based on the determined proximity of the steerable distal tip relative to the lumen wall.

9. The catheter navigation system of claim 8, wherein, Determining the proximity of the steerable distal tip relative to one or more lumen walls includes: determining a first distance of a first side of the distal tip to a first lumen wall; and determining a second distance of a second side of the distal tip to a second lumen wall, wherein the second distance is greater than the first distance; and wherein the steering signal is to steer the distal tip toward the second side of the distal tip.

10. The catheter navigation system of claim 8, wherein, The operations further include identifying a center of the lumen based on the determined proximity.

11. The catheter navigation system of claim 8, wherein, The steering signal is a first steering signal, and the operations further include: identifying, based on the proximity signal, a bifurcation of a first lumen and a second lumen of a patient; based on an anatomical model of the patient, identifying the first lumen as providing a path to a navigation target in the anatomical model; and generating a second steering signal to steer the distal tip into the first lumen.

12. The catheter navigation system of claim 8, wherein, The proximity sensor includes: a proximity emitter; and at least one proximity receiver positioned at least partially around a circumference of the distal tip.

13. A method for navigating a catheter as the catheter is advanced within a lumen, the method comprising: receiving, at a catheter controller, a proximity signal from a proximity sensor in a steerable distal tip of the catheter, the proximity sensor being at least one of an infrared sensor, an acoustic sensor, or a temperature sensor; providing the proximity signal to a trained machine learning (ML) model; receiving an output from the ML model in response to the proximity signal; identifying a steering target based on the output from the ML model; and automatically bending the distal tip toward the steering target by the catheter controller. The steering target is a central axis of the lumen.

14. The method of claim 13, wherein, The lumen is a first lumen, the catheter is positioned at a bifurcation of a second lumen and a third lumen, and the steering target is one of the second lumen or the third lumen.

15. The method of claim 13, wherein, 16. A catheter navigation system comprising: a catheter including a steerable distal tip, the steerable distal tip including a proximity sensor; and a catheter controller coupled to the catheter, the catheter controller including: a processor; and a memory storing instructions that, when executed by the processor, cause the catheter controller to perform operations including: receiving, from the catheter, a proximity signal generated by the proximity sensor; based on the proximity signal, detecting an anatomical structure in proximity to the distal tip; and generating a steering signal to steer the steerable distal tip away from the detected anatomical structure. The anatomical structure is a lumen wall.

17. The catheter navigation system of claim 16, wherein, The anatomical structure is tissue separating two lumens at an interface.

18. The catheter navigation system of claim 16, wherein, ​

Images