Ultrasound sensor medical systems for use with external transducers and related methods

Abstract

Ultrasound imaging systems and methods include a flexible medical device configured to be inserted within a patient anatomy, an ultrasound sensor configured to receive ultrasound waves emitted from an ultrasound transducer external to the patient anatomy when the ultrasound sensor is within the patient anatomy, and a control system coupled to the ultrasound sensor and configured to generate an image based on a signal received from the ultrasound sensor.

Description

Intuitive Docket No.: P07036-WO Attorney Docket No.: 33685 / 70822 PC ULTRASOUND SENSOR MEDICAL SYSTEMS FOR USE WITH EXTERNAL TRANSDUCERS AND RELATED METHODSCROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of priority to U.S. Provisional Application No.63 / 779,411, filed March 28, 2025, the entire contents of which are hereby incorporated by reference herein.FIELD

[0002] Disclosed embodiments relate to ultrasound imaging systems.BACKGROUND

[0003] Minimally invasive medical techniques are intended to reduce the amount of tissue that is damaged during medical procedures, thereby reducing patient recovery time, discomfort, and harmful side effects. Such minimally invasive techniques may be performed through natural orifices in a patient anatomy or through one or more surgical incisions. Through these natural orifices or incisions, physicians may insert minimally invasive medical instruments (including surgical, diagnostic, therapeutic, and / or biopsy instruments) to reach a target tissue location. One such minimally invasive technique is to use a flexible and / or steerable elongate device, such as a flexible catheter, that can be inserted into anatomic passageways and navigated toward a region of interest within the patient anatomy.SUMMARY

[0004] The following presents a simplified summary of various examples described herein and is not intended to identify key or critical elements or to delineate the scope of the claims.

[0005] According to a first example, a medical system is disclosed herein that includes a flexible medical device configured to be inserted within a patient anatomy, an ultrasound sensor coupled to the flexible medical device and configured to receive ultrasound waves emitted from an ultrasound transducer external to the patient anatomy when the ultrasound sensor is within the patient anatomy, and a control system coupled to the ultrasound sensor and configured to generate an image based on a signal received from the ultrasound sensor.

[0006] In some examples, the medical system includes the ultrasound transducer, the control system coupled to the ultrasound transducer to control the operation thereof and / or the control system is configured to display fluoroscopy images to a user to aid with the orientation and location of the external transducer.

[0007] In some examples, the medical system includes a sensor associated with the flexible medical device, the sensor configured to generate sensor data indicating at least one of aIntuitive Docket No.: P07036-WO Attorney Docket No.: 33685 / 70822 PC position of the flexible medical device or an orientation of the flexible medical device. In further examples, the sensor is a shape sensor, the control system is configured to determine position information for the ultrasound transducer based on the sensor data, and / or the control system is configured to determine a position of target tissue within the image based at least partially on the sensor data. In yet further examples, the medical system includes a user interface and the control system is configured to provide the position information to the user interface and / or the medical system includes a robotic arm having the ultrasound transducer coupled thereto and the control system is configured to move to robotic arm to dispose the ultrasound transducer in at least one of a position or orientation based on the position information.

[0008] In some examples, the medical device is an elongate device and the ultrasound sensor is coupled to a distal end of the elongate device. In further examples, the elongate device is an elongate shaft with a needle coupled to an end of the elongate shaft and the ultrasound sensor is coupled to the needle and / or the elongate device is a stylet and the ultrasound sensor is coupled to a distal end of the stylet.

[0009] In further examples, the distal end of the elongate device includes a distally facing end surface and the ultrasound sensor is exposed along the end surface. In yet further examples, the ultrasound sensor includes a plurality of sensors aligned in a linear array across the end face.

[0010] In further examples, the medical system includes a steerable catheter defining a working channel, the elongate device configured to be received within the working channel. In yet further examples, the steerable catheter includes a shape sensor, the control system configured to display position data for the steerable catheter based on data from the shape sensor. In some examples, the control system is configured overlay shape data from the shape sensor with computed tomography (CT) scan data to provide an indication of location and pointing direction to locate target tissue and / or the medical system includes a robotic manipulator arm, the external transducer being coupled to the robotic manipulator arm, and wherein the control system is configured to operate the robotic manipulator arm so that the external transducer tracks movement of the steerable catheter to locate the ultrasound sensor.

[0011] In a second example, an ultrasound imaging method is disclosed that includes receiving, by a control system, a signal from an ultrasound sensor located within a patient anatomy corresponding to ultrasound waves generated by an ultrasound transducer external to the patient and generating, by the control system, an image based on the signal.Intuitive Docket No.: P07036-WO Attorney Docket No.: 33685 / 70822 PC

[0012] In some examples, the method includes generating sensor data with a sensor associated with a flexible medical device having the ultrasound sensor coupled thereto, the sensor data indicating at least one of a position of the flexible medical device or an orientation of the flexible medical device.

[0013] In further examples, generating sensor data includes generating shape sensor data.

[0014] In further examples, the method includes determining position information for the ultrasound transducer based on the sensor data. In yet further examples, the method includes providing the position information to a user interface to help a user locate the ultrasound sensor and / or moving to robotic arm to control at least one of a position or orientation of the ultrasound transducer based on the position information.

[0015] In further examples, the method includes determining a position of target tissue within the image based at least partially on the sensor data.

[0016] In some examples, the medical device is an elongate device and the method includes inserting the elongate device into a working channel of a steerable catheter.

[0017] In further examples, the method includes displaying position data for the steerable catheter based on data from a shape sensor of the steerable catheter. In yet further examples, displaying position data for the steerable catheter includes overlaying shape data from the shape sensor with computed tomography (CT) scan data to provide an indication of location and pointing direction to locate target tissue and / or operating a robotic manipulator arm so that the external transducer coupled thereto tracks movement of the steerable catheter to locate the ultrasound sensor.

[0018] In some examples, the method includes displaying fluoroscopy images to a user to aid with the orientation and location of the external transducer.

[0019] It is to be understood that both the foregoing general description and the following detailed description are illustrative and explanatory in nature and are intended to provide an understanding of the present disclosure without limiting the scope of the present disclosure. In that regard, additional aspects, features, and advantages of the present disclosure will be apparent to one skilled in the art from the following detailed description.BRIEF DESCRIPTIONS OF THE DRAWINGS

[0020] FIG. 1 is a simplified diagram of a medical system according to some embodiments.

[0021] FIG. 2A is a simplified diagram of a medical instrument system according to some embodiments.

[0022] FIG. 2B is a simplified diagram of a medical instrument including a medical tool within an elongate device according to some embodiments.Intuitive Docket No.: P07036-WO Attorney Docket No.: 33685 / 70822 PC

[0023] FIGS. 3 A and 3B are simplified diagrams of side views of a patient coordinate space including a medical instrument mounted on an insertion assembly according to some embodiments.

[0024] FIG. 4A is a simplified diagram of an ultrasound imaging system according to some embodiments.

[0025] FIG. 4B is a schematic view of a flexible medical device having an array of ultrasound sensors coupled to an end surface thereof according to some embodiments.

[0026] FIG. 4C is an example ultrasound image generated from data of an ultrasound receiver according to some embodiments.

[0027] FIG. 4D is a sectional view of a needle having an ultrasound sensor coupled thereto according to some embodiments.

[0028] FIG. 4E is a sectional view of a robotic arm having an ultrasound transducer coupled thereto according to some embodiments.

[0029] FIG. 4F is a simplified diagram of an ultrasound imaging system according to some embodiments.

[0030] FIG. 5 is a flowchart for an ultrasound imaging method according to some embodiments.

[0031] Embodiments of the present disclosure and their advantages are best understood by referring to the detailed description that follows. It should be appreciated that like reference numerals are used to identify like elements illustrated in one or more of the figures, wherein showings therein are for purposes of illustrating embodiments of the present disclosure and not for purposes of limiting the same.DETAILED DESCRIPTION

[0032] In the following description, specific details are set forth describing some embodiments consistent with the present disclosure. Numerous specific details are set forth in order to provide a thorough understanding of the embodiments. It will be apparent, however, to one skilled in the art that some embodiments may be practiced without some or all of these specific details. The specific embodiments disclosed herein are meant to be illustrative but not limiting. One skilled in the art may realize other elements that, although not specifically described here, are within the scope and the spirit of this disclosure. In addition, to avoid unnecessary repetition, one or more features shown and described in association with one embodiment may be incorporated into other embodiments unless specifically described otherwise or if the one or more features would make an embodiment non-functional. In someIntuitive Docket No.: P07036-WO Attorney Docket No.: 33685 / 70822 PC instances, well known methods, procedures, components, and circuits have not been described in detail so as not to unnecessarily obscure aspects of the embodiments.

[0033] This disclosure describes various instruments and portions of instruments in terms of their state in three-dimensional space. As used herein, the term “position” refers to the location of an object or a portion of an object in a three-dimensional space (e.g., three degrees of translational freedom along Cartesian x-, y-, and z-coordinates). As used herein, the term “orientation” refers to the rotational placement of an object or a portion of an object (e.g., one or more degrees of rotational freedom such as, roll, pitch, and yaw). As used herein, the term “pose” refers to the position of an object or a portion of an object in at least one degree of translational freedom and to the orientation of that object or portion of the object in at least one degree of rotational freedom (e.g., up to six total degrees of freedom). As used herein, the term “shape” refers to a set of poses, positions, and / or orientations measured along an object. As used herein, the term “distal” refers to a position that is closer to a procedural site and the term “proximal” refers to a position that is further from the procedural site. Accordingly, the distal portion or distal end of an instrument is closer to a procedural site than a proximal portion or proximal end of the instrument when the instrument is being used as designed to perform a procedure.

[0034] It is advantageous to biopsy lesions in the lung for diagnosis purposes. Using a CT scan, a path can be created to the lesion for an endo-luminal biopsy. However, because of breathing and other factors, there may be CT scan to body divergence and thus the path could be one or two centimeters away from the lesion location noted based on when the CT image is segmented. A real time update of the location would be helpful to ensure the proper location of lesion.

[0035] As provided herein, a solution to this problem includes generating an image at a target location based on a signal received from one or more ultrasound sensors delivered to the target location. An ultrasound transducer external to the patient transmits ultrasound waves to be received at the ultrasound sensors, which can then be utilized to generate an image of the target location. This system utilizes the large array of the external transducer to generate sufficient ultrasound waves within the patient to generate a useable image. Further, by including a plurality of ultrasound sensors at the treatment location, such as in a linear array, a higher quality image can be generated. The ultrasound sensors can be coupled to a needle, a separate probe device, or at the end of a flexible elongate device.

[0036] The ultrasound sensors can be delivered to the treatment location through a working channel of a steerable catheter or bronchoscope within the lung or other parts of the body. InIntuitive Docket No.: P07036-WO Attorney Docket No.: 33685 / 70822 PC some examples, the catheter or bronchoscope can include a shape sensor. Utilizing the shape data from the shape sensor, the location and pointing direction of the ultrasound probe can be determined. If positioned at the lesion, the ultrasound sensors will deliver an image of the lesion to confirm positioning. After the lesion has been located, the location may be extracted from the shape sensor data and image information. Otherwise, the ultrasound sensors can be utilized to scope one or more areas to find the lesion. Further, a segmented map of the patient based on the original CT scan data can be updated with the real time location of the lesion to eliminate or minimize CT scan to body divergence.

[0037] FIG. 1 is a simplified diagram of a medical system 100 according to some embodiments. The medical system 100 may be suitable for use in, for example, surgical, diagnostic (e.g., biopsy), or therapeutic (e.g., ablation, electroporation, etc.) procedures. While some embodiments are provided herein with respect to such procedures, any reference to medical or surgical instruments and medical or surgical methods is non-limiting. The systems, instruments, and methods described herein may be used for animals, human cadavers, animal cadavers, portions of human or animal anatomy, non-surgical diagnosis, as well as for industrial systems, general or special purpose robotic systems, general or special purpose teleoperational systems, or robotic medical systems.

[0038] As shown in FIG. 1, medical system 100 may include a manipulator assembly 102 that controls the operation of a medical instrument 104 in performing various procedures on a patient P. Medical instrument 104 may extend into an internal site within the body of patient P via an opening in the body of patient P. The manipulator assembly 102 may be teleoperated, non-teleoperated, or a hybrid teleoperated and non-teleoperated assembly with one or more degrees of freedom of motion that may be motorized and / or one or more degrees of freedom of motion that may be non-motorized (e.g., manually operated). The manipulator assembly 102 may be mounted to and / or positioned near a patient table T. A master assembly 106 allows an operator O (e.g., a surgeon, a clinician, a physician, or other user) to control the manipulator assembly 102. In some examples, the master assembly 106 allows the operator O to view the procedural site or other graphical or informational displays. In some examples, the manipulator assembly 102 may be excluded from the medical system 100 and the instrument 104 may be controlled directly by the operator O. In some examples, the manipulator assembly 102 may be manually controlled by the operator O. Direct operator control may include various handles and operator interfaces for hand-held operation of the instrument 104.

[0039] The master assembly 106 may be located at a surgeon’s console which is in proximity to (e.g., in the same room as) a patient table T on which patient P is located, such asIntuitive Docket No.: P07036-WO Attorney Docket No.: 33685 / 70822 PC at the side of the patient table T. In some examples, the master assembly 106 is remote from the patient table T, such as in a different room or a different building from the patient table T. The master assembly 106 may include one or more control devices for controlling the manipulator assembly 102. The control devices may include any number of a variety of input devices, such as joysticks, trackballs, scroll wheels, directional pads, buttons, data gloves, trigger-guns, hand-operated controllers, voice recognition devices, motion or presence sensors, and / or the like.

[0040] The manipulator assembly 102 supports the medical instrument 104 and may include a kinematic structure of links that provide a set-up structure. The links may include one or more non-servo controlled links (e.g., one or more links that may be manually positioned and locked in place) and / or one or more servo controlled links (e.g., one or more links that may be controlled in response to commands, such as from a control system 112). The manipulator assembly 102 may include a plurality of actuators (e.g., motors) that drive inputs on the medical instrument 104 in response to commands, such as from the control system 112. The actuators may include drive systems that move the medical instrument 104 in various ways when coupled to the medical instrument 104. For example, one or more actuators may advance medical instrument 104 into a naturally or surgically created anatomic orifice. Actuators may control articulation of the medical instrument 104, such as by moving the distal end (or any other portion) of medical instrument 104 in multiple degrees of freedom. These degrees of freedom may include three degrees of linear motion (e.g., linear motion along the X, Y, Z Cartesian axes) and in three degrees of rotational motion (e.g., rotation about the X, Y, Z Cartesian axes). One or more actuators may control rotation of the medical instrument about a longitudinal axis. Actuators can also be used to move an articulable end effector of medical instrument 104, such as for grasping tissue in the jaws of a biopsy device and / or the like, or may be used to move or otherwise control tools (e.g., imaging tools, ablation tools, biopsy tools, electroporation tools, etc.) that are inserted within the medical instrument 104.

[0041] The medical system 100 may include a sensor system 108 with one or more subsystems for receiving information about the manipulator assembly 102 and / or the medical instrument 104. Such sub-systems may include a position sensor system (e.g., that uses electromagnetic (EM) sensors or other types of sensors that detect position or location); a shape sensor system for determining the position, orientation, speed, velocity, pose, and / or shape of a distal end and / or of one or more segments along a flexible body of the medical instrument 104; a visualization system (e.g., using a color imaging device, an infrared imaging device, an ultrasound imaging device, an x-ray imaging device, a fluoroscopic imaging device, aIntuitive Docket No.: P07036-WO Attorney Docket No.: 33685 / 70822 PC computed tomography (CT) imaging device, a magnetic resonance imaging (MRI) imaging device, or some other type of imaging device) for capturing images, such as from the distal end of medical instrument 104 or from some other location; and / or actuator position sensors such as resolvers, encoders, potentiometers, and the like that describe the rotation and / or orientation of the actuators controlling the medical instrument 104.

[0042] The medical system 100 may include a display system 110 for displaying an image or representation of the procedural site and the medical instrument 104. Display system 110 and master assembly 106 may be oriented so physician O can control medical instrument 104 and master assembly 106 with the perception of telepresence.

[0043] In some embodiments, the medical instrument 104 may include a visualization system, which may include an image capture assembly that records a concurrent or real-time image of a procedural site and provides the image to the operator O through one or more displays of display system 110. The image capture assembly may include various types of imaging devices. The concurrent image may be, for example, a two-dimensional image or a three-dimensional image captured by an endoscope positioned within the anatomical procedural site. In some examples, the visualization system may include endoscopic components that may be integrally or removably coupled to medical instrument 104. Additionally or alternatively, a separate endoscope, attached to a separate manipulator assembly, may be used with medical instrument 104 to image the procedural site. The visualization system may be implemented as hardware, firmware, software or a combination thereof which interact with or are otherwise executed by one or more computer processors, such as of the control system 112.

[0044] Display system 110 may also display an image of the procedural site and medical instruments, which may be captured by the visualization system. In some examples, the medical system 100 provides a perception of telepresence to the operator O. For example, images captured by an imaging device at a distal portion of the medical instrument 104 may be presented by the display system 110 to provide the perception of being at the distal portion of the medical instrument 104 to the operator O. The input to the master assembly 106 provided by the operator O may move the distal portion of the medical instrument 104 in a manner that corresponds with the nature of the input (e.g., distal tip turns right when a trackball is rolled to the right) and results in corresponding change to the perspective of the images captured by the imaging device at the distal portion of the medical instrument 104. As such, the perception of telepresence for the operator O is maintained as the medical instrument 104 is moved using the master assembly 106. The operator O can manipulate the medical instrument 104 and handIntuitive Docket No.: P07036-WO Attorney Docket No.: 33685 / 70822 PC controls of the master assembly 106 as if viewing the workspace in substantially true presence, simulating the experience of an operator that is physically manipulating the medical instrument 104 from within the patient anatomy.

[0045] In some examples, the display system 110 may present virtual images of a procedural site that are created using image data recorded pre-operatively (e.g., prior to the procedure performed by the medical instrument system 200) or intra-operatively (e.g., concurrent with the procedure performed by the medical instrument system 200), such as image data created using computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET), fluoroscopy, thermography, ultrasound, optical coherence tomography (OCT), thermal imaging, impedance imaging, laser imaging, nanotube X-ray imaging, and / or the like. The virtual images may include two-dimensional, three-dimensional, or higherdimensional (e.g., including, for example, time based or velocity-based information) images. In some examples, one or more models are created from pre-operative or intra-operative image data sets and the virtual images are generated using the one or more models.

[0046] In some examples, for purposes of imaged guided medical procedures, display system 110 may display a virtual image that is generated based on tracking the location of medical instrument 104. For example, the tracked location of the medical instrument 104 may be registered (e.g., dynamically referenced) with the model generated using the pre-operative or intra-operative images, with different portions of the model corresponding with different locations of the patient anatomy. As the medical instrument 104 moves through the patient anatomy, the registration is used to determine portions of the model corresponding with the location and / or perspective of the medical instrument 104 and virtual images are generated using the determined portions of the model. This may be done to present the operator O with virtual images of the internal procedural site from viewpoints of medical instrument 104 that correspond with the tracked locations of the medical instrument 104.

[0047] The medical system 100 may also include the control system 112, which may include processing circuitry that implements the some or all of the methods or functionality discussed herein. The control system 112 may include at least one memory and at least one processor for controlling the operations of the manipulator assembly 102, the medical instrument 104, the master assembly 106, the sensor system 108, and / or the display system 110. Control system 112 may include instructions (e.g., a non-transitory machine-readable medium storing the instructions) that when executed by the at least one processor, configures the one or more processors to implement some or all of the methods or functionality discussed herein. While the control system 112 is shown as a single block in FIG. 1, the control system 112 may includeIntuitive Docket No.: P07036-WO Attorney Docket No.: 33685 / 70822 PC two or more separate data processing circuits with one portion of the processing being performed at the manipulator assembly 102, another portion of the processing being performed at the master assembly 106, and / or the like. In some examples, the control system 112 may include other types of processing circuitry, such as application- specific integrated circuits (ASICs) and / or field-programmable gate array (FPGAs). The control system 112 may be implemented using hardware, firmware, software, or a combination thereof.

[0048] In some examples, the control system 112 may receive feedback from the medical instrument 104, such as force and / or torque feedback. Responsive to the feedback, the control system 112 may transmit signals to the master assembly 106. In some examples, the control system 112 may transmit signals instructing one or more actuators of the manipulator assembly 102 to move the medical instrument 104. In some examples, the control system 112 may transmit informational displays regarding the feedback to the display system 110 for presentation or perform other types of actions based on the feedback.

[0049] The control system 112 may include a virtual visualization system to provide navigation assistance to operator O when controlling the medical instrument 104 during an image-guided medical procedure. Virtual navigation using the virtual visualization system may be based upon an acquired pre-operative or intra-operative dataset of anatomic passageways of the patient P. The control system 112 or a separate computing device may convert the recorded images, using programmed instructions alone or in combination with operator inputs, into a model of the patient anatomy. The model may include a segmented two-dimensional or three-dimensional composite representation of a partial or an entire anatomic organ or anatomic region. An image data set may be associated with the composite representation. The virtual visualization system may obtain sensor data from the sensor system 108 that is used to compute an (e.g., approximate) location of the medical instrument 104 with respect to the anatomy of patient P. The sensor system 108 may be used to register and display the medical instrument 104 together with the pre-operatively or intra-operatively recorded images. For example, PCT Publication WO 2016 / 191298 (published December 1, 2016 and titled “Systems and Methods of Registration for Image Guided Surgery”), which is incorporated by reference herein in its entirety, discloses example systems.

[0050] During a virtual navigation procedure, the sensor system 108 may be used to compute the (e.g., approximate) location of the medical instrument 104 with respect to the anatomy of patient P. The location can be used to produce both macro-level (e.g., external) tracking images of the anatomy of patient P and virtual internal images of the anatomy of patient P. The system may include one or more electromagnetic (EM) sensors, fiber opticIntuitive Docket No.: P07036-WO Attorney Docket No.: 33685 / 70822 PC sensors, and / or other sensors to register and display a medical instrument together with pre-operatively recorded medical images. For example, U.S. Patent No. 8,900,131 (filed May 13, 2011 and titled “Medical System Providing Dynamic Registration of a Model of an Anatomic Structure for Image-Guided Surgery”), which is incorporated by reference herein in its entirety, discloses example systems.

[0051] Medical system 100 may further include operations and support systems (not shown) such as illumination systems, steering control systems, irrigation systems, and / or suction systems. In some embodiments, the medical system 100 may include more than one manipulator assembly and / or more than one master assembly. The exact number of manipulator assemblies may depend on the medical procedure and space constraints within the procedural room, among other factors. Multiple master assemblies may be co-located or they may be positioned in separate locations. Multiple master assemblies may allow more than one operator to control one or more manipulator assemblies in various combinations.

[0052] FIG. 2A is a simplified diagram of a medical instrument system 200 according to some embodiments. The medical instrument system 200 includes a flexible elongate device 202 (also referred to as elongate device 202), a drive unit 204, and a medical tool 226 that collectively is an example of a medical instrument 104 of a medical system 100. The medical system 100 may be a teleoperated system, a non-teleoperated system, or a hybrid teleoperated and non-teleoperated system, as explained with reference to FIG. 1. A visualization system 231, tracking system 230, and navigation system 232 are also shown in FIG. 2A and are example components of the control system 112 of the medical system 100. In some examples, the medical instrument system 200 may be used for non-teleoperational exploratory procedures or in procedures involving traditional manually operated medical instruments, such as endoscopy. The medical instrument system 200 may be used to gather (e.g., measure) a set of data points corresponding to locations within anatomic passageways of a patient, such as patient P.

[0053] The elongate device 202 is coupled to the drive unit 204. The elongate device 202 includes a channel 221 through which the medical tool 226 may be inserted. The elongate device 202 navigates within patient anatomy to deliver the medical tool 226 to a procedural site. The elongate device 202 includes a flexible body 216 having a proximal end 217 and a distal end 218. In some examples, the flexible body 216 may have an approximately 3 mm outer diameter. Other flexible body outer diameters may be larger or smaller.

[0054] Medical instrument system 200 may include the tracking system 230 for determining the position, orientation, speed, velocity, pose, and / or shape of the flexible body 216 at theIntuitive Docket No.: P07036-WO Attorney Docket No.: 33685 / 70822 PC distal end 218 and / or of one or more segments 224 along flexible body 216, as will be described in further detail below. The tracking system 230 may include one or more sensors and / or imaging devices. The flexible body 216, such as the length between the distal end 218 and the proximal end 217, may include multiple segments 224. The tracking system 230 may be implemented using hardware, firmware, software, or a combination thereof. In some examples, the tracking system 230 is part of control system 112 shown in FIG. 1.

[0055] Tracking system 230 may track the distal end 218 and / or one or more of the segments 224 of the flexible body 216 using a shape sensor 222. The shape sensor 222 may include an optical fiber aligned with the flexible body 216 (e.g., provided within an interior channel of the flexibly body 216 or mounted externally along the flexible body 216). In some examples, the optical fiber may have a diameter of approximately 200 pm. In other examples, the diameter may be larger or smaller. The optical fiber of the shape sensor 222 may form a fiber optic bend sensor for determining the shape of flexible body 216. Optical fibers including Fiber Bragg Gratings (FBGs) may be used to provide strain measurements in structures in one or more dimensions. Various systems and methods for monitoring the shape and relative position of an optical fiber in three dimensions, which may be applicable in some embodiments, are described in U.S. Patent Application Publication No. 2006 / 0013523 (filed July 13, 2005 and titled “Fiber optic position and shape sensing device and method relating thereto”); U.S. Patent No.7,772,541 (filed on March 12, 2008 and titled “Fiber Optic Position and / or Shape Sensing Based on Rayleigh Scatter”); and U.S. Patent No. 8,773,650 (filed on Sept. 2, 2010 and titled “Optical Position and / or Shape Sensing”), which are all incorporated by reference herein in their entireties. Sensors in some embodiments may employ other suitable strain sensing techniques, such as Rayleigh scattering, Raman scattering, Brillouin scattering, and Fluorescence scattering.

[0056] In some examples, the shape of the flexible body 216 may be determined using other techniques. For example, a history of the position and / or pose of the distal end 218 of the flexible body 216 can be used to reconstruct the shape of flexible body 216 over an interval of time (e.g., as the flexible body 216 is advanced or retracted within a patient anatomy). In some examples, the tracking system 230 may alternatively and / or additionally track the distal end 218 of the flexible body 216 using a position sensor system 220. Position sensor system 220 may be a component of an EM sensor system with the position sensor system 220 including one or more position sensors. Although the position sensor system 220 is shown as being near the distal end 218 of the flexible body 216 to track the distal end 218, the number and location of the position sensors of the position sensor system 220 may vary to track different regionsIntuitive Docket No.: P07036-WO Attorney Docket No.: 33685 / 70822 PC along the flexible body 216. In one example, the position sensors include conductive coils that may be subjected to an externally generated electromagnetic field. Each coil of position sensor system 220 may produce an induced electrical signal having characteristics that depend on the position and orientation of the coil relative to the externally generated electromagnetic field. The position sensor system 220 may measure one or more position coordinates and / or one or more orientation angles associated with one or more portions of flexible body 216. In some examples, the position sensor system 220 may be configured and positioned to measure six degrees of freedom, e.g., three position coordinates X, Y, Z and three orientation angles indicating pitch, yaw, and roll of a base point. In some examples, the position sensor system 220 may be configured and positioned to measure five degrees of freedom, e.g., three position coordinates X, Y, Z and two orientation angles indicating pitch and yaw of a base point. Further description of a position sensor system, which may be applicable in some embodiments, is provided in U.S. Patent No. 6,380,732 (filed August 11, 1999 and titled “Six-Degree of Freedom Tracking System Having a Passive Transponder on the Object Being Tracked”), which is incorporated by reference herein in its entirety.

[0057] In some embodiments, the tracking system 230 may alternately and / or additionally rely on a collection of pose, position, and / or orientation data stored for a point of an elongate device 202 and / or medical tool 226 captured during one or more cycles of alternating motion, such as breathing. This stored data may be used to develop shape information about the flexible body 216. In some examples, a series of position sensors (not shown), such as EM sensors like the sensors in position sensor 220 or some other type of position sensors may be positioned along the flexible body 216 and used for shape sensing. In some examples, a history of data from one or more of these position sensors taken during a procedure may be used to represent the shape of elongate device 202, particularly if an anatomic passageway is generally static.

[0058] FIG. 2B is a simplified diagram of the medical tool 226 within the elongate device 202 according to some embodiments. The flexible body 216 of the elongate device 202 may include the channel 221 sized and shaped to receive the medical tool 226. In some embodiments, the medical tool 226 may be used for procedures such as diagnostics, imaging, surgery, biopsy, ablation, illumination, irrigation, suction, electroporation, etc. Medical tool 226 can be deployed through channel 221 of flexible body 216 and operated at a procedural site within the anatomy. Medical instrument 226 may be, for example, an image capture probe, a biopsy tool (e.g., a needle, grasper, brush, etc.), an ablation tool (e.g., a laser ablation tool, radio frequency (RF) ablation tool, cryoablation tool, thermal ablation tool, heated liquid ablation tool, etc.), an electroporation tool, and / or another surgical, diagnostic, or therapeuticIntuitive Docket No.: P07036-WO Attorney Docket No.: 33685 / 70822 PC tool. In some examples, the medical tool 226 may include an end effector having a single working member such as a scalpel, a blunt blade, an optical fiber, an electrode, and / or the like. Other end types of end effectors may include, for example, forceps, graspers, scissors, staplers, clip appliers, and / or the like. Other end effectors may further include electrically activated end effectors such as electrosurgical electrodes, transducers, sensors, and / or the like.

[0059] The medical tool 226 may be a biopsy tool used to remove sample tissue or a sampling of cells from a target anatomic location. In some examples, the biopsy tool is a flexible needle. The biopsy tool may further include a sheath that can surround the flexible needle to protect the needle and interior surface of the channel 221 when the biopsy tool is within the channel 221. The medical tool 226 may be an image capture probe that includes a distal portion with a stereoscopic or monoscopic camera that may be placed at or near the distal end 218 of flexible body 216 for capturing images (e.g., still or video images). The captured images may be processed by the visualization system 231 for display and / or provided to the tracking system 230 to support tracking of the distal end 218 of the flexible body 216 and / or one or more of the segments 224 of the flexible body 216. The image capture probe may include a cable for transmitting the captured image data that is coupled to an imaging device at the distal portion of the image capture probe. In some examples, the image capture probe may include a fiber-optic bundle, such as a fiberscope, that couples to a more proximal imaging device of the visualization system 231. The image capture probe may be single- spectral or multi-spectral, for example, capturing image data in one or more of the visible, near-infrared, infrared, and / or ultraviolet spectrums. The image capture probe may also include one or more light emitters that provide illumination to facilitate image capture. In some examples, the image capture probe may use ultrasound, x-ray, fluoroscopy, CT, MRI, or other types of imaging technology.

[0060] In some examples, the image capture probe is inserted within the flexible body 216 of the elongate device 202 to facilitate visual navigation of the elongate device 202 to a procedural site and then is replaced within the flexible body 216 with another type of medical tool 226 that performs the procedure. In some examples, the image capture probe may be within the flexible body 216 of the elongate device 202 along with another type of medical tool 226 to facilitate simultaneous image capture and tissue intervention, such as within the same channel 221 or in separate channels. A medical tool 226 may be advanced from the opening of the channel 221 to perform the procedure (or some other functionality) and then retracted back into the channel 221 when the procedure is complete. The medical tool 226 may be removedIntuitive Docket No.: P07036-WO Attorney Docket No.: 33685 / 70822 PC from the proximal end 217 of the flexible body 216 or from another optional instrument port (not shown) along flexible body 216.

[0061] In some examples, the elongate device 202 may include integrated imaging capability rather than utilize a removable image capture probe. For example, the imaging device (or fiber-optic bundle) and the light emitters may be located at the distal end 218 of the elongate device 202. The flexible body 216 may include one or more dedicated channels that carry the cable(s) and / or optical fiber(s) between the distal end 218 and the visualization system 231. Here, the medical instrument system 200 can perform simultaneous imaging and tool operations.

[0062] In some examples, the medical tool 226 is capable of controllable articulation. The medical tool 226 may house cables (which may also be referred to as pull wires), linkages, or other actuation controls (not shown) that extend between its proximal and distal ends to controllably bend the distal end of medical tool 226, such as discussed herein for the flexible elongate device 202. The medical tool 226 may be coupled to a drive unit 204 and the manipulator assembly 102. In these examples, the elongate device 202 may be excluded from the medical instrument system 200 or may be a flexible device that does not have controllable articulation. Steerable instruments or tools, applicable in some embodiments, are further described in detail in U.S. Patent No. 7,316,681 (filed on Oct. 4, 2005 and titled “Articulated Surgical Instrument for Performing Minimally Invasive Surgery with Enhanced Dexterity and Sensitivity”) and U.S. Patent No. 9,259,274 (filed Sept. 30, 2008 and titled “Passive Preload and Capstan Drive for Surgical Instruments”), which are incorporated by reference herein in their entireties.

[0063] The flexible body 216 of the elongate device 202 may also or alternatively house cables, linkages, or other steering controls (not shown) that extend between the drive unit 204 and the distal end 218 to controllably bend the distal end 218 as shown, for example, by broken dashed line depictions 219 of the distal end 218 in FIG. 2A. In some examples, at least four cables are used to provide independent up-down steering to control a pitch of the distal end 218 and left-right steering to control a yaw of the distal end 281. In these examples, the flexible elongate device 202 may be a steerable catheter. Examples of steerable catheters, applicable in some embodiments, are described in detail in PCT Publication WO 2019 / 018736 (published Jan. 24, 2019 and titled “Flexible Elongate Device Systems and Methods”), which is incorporated by reference herein in its entirety.

[0064] In embodiments where the elongate device 202 and / or medical tool 226 are actuated by a teleoperational assembly (e.g., the manipulator assembly 102), the drive unit 204 mayIntuitive Docket No.: P07036-WO Attorney Docket No.: 33685 / 70822 PC include drive inputs that removably couple to and receive power from drive elements, such as actuators, of the teleoperational assembly. In some examples, the elongate device 202 and / or medical tool 226 may include gripping features, manual actuators, or other components for manually controlling the motion of the elongate device 202 and / or medical tool 226. The elongate device 202 may be steerable or, alternatively, the elongate device 202 may be nonsteerable with no integrated mechanism for operator control of the bending of distal end 218. In some examples, one or more channels 221 (which may also be referred to as lumens), through which medical tools 226 can be deployed and used at a target anatomical location, may be defined by the interior walls of the flexible body 216 of the elongate device 202.

[0065] In some examples, the medical instrument system 200 (e.g., the elongate device 202 or medical tool 226) may include a flexible bronchial instrument, such as a bronchoscope or bronchial catheter, for use in examination, diagnosis, biopsy, and / or treatment of a lung. The medical instrument system 200 may also be suited for navigation and treatment of other tissues, via natural or surgically created connected passageways, in any of a variety of anatomic systems, including the colon, the intestines, the kidneys and kidney calices, the brain, the heart, the circulatory system including vasculature, and / or the like.

[0066] The information from the tracking system 230 may be sent to the navigation system 232, where the information may be combined with information from the visualization system 231 and / or pre-operatively obtained models to provide the physician, clinician, surgeon, or other operator with real-time position information. In some examples, the real-time position information may be displayed on the display system 110 for use in the control of the medical instrument system 200. In some examples, the navigation system 232 may utilize the position information as feedback for positioning medical instrument system 200. Various systems for using fiber optic sensors to register and display a surgical instrument with surgical images, applicable in some embodiments, are provided in U.S. Patent No. 8,900,131 (filed May 13, 2011 and titled “Medical System Providing Dynamic Registration of a Model of an Anatomic Structure for Image-Guided Surgery”), which is incorporated by reference herein in its entirety.

[0067] FIGS. 3 A and 3B are simplified diagrams of side views of a patient coordinate space including a medical instrument mounted on an insertion assembly according to some embodiments. As shown in FIGS. 3 A and 3B, a surgical environment 300 may include a patient P positioned on the patient table T. Patient P may be stationary within the surgical environment 300 in the sense that gross patient movement is limited by sedation, restraint, and / or other means. Cyclic anatomic motion, including respiration and cardiac motion, of patient P may continue. Within surgical environment 300, a medical instrument 304 is used to perform aIntuitive Docket No.: P07036-WO Attorney Docket No.: 33685 / 70822 PC medical procedure which may include, for example, surgery, biopsy, ablation, illumination, irrigation, suction, or electroporation. The medical instrument 304 may also be used to perform other types of procedures, such as a registration procedure to associate the position, orientation, and / or pose data captured by the sensor system 108 to a desired (e.g., anatomical or system) reference frame. The medical instrument 304 may be, for example, the medical instrument 104. In some examples, the medical instrument 304 may include an elongate device 310 (e.g., a catheter) coupled to an instrument body 312. Elongate device 310 includes one or more channels sized and shaped to receive a medical tool.

[0068] Elongate device 310 may also include one or more sensors (e.g., components of the sensor system 108). In some examples, a shape sensor 314 may be fixed at a proximal point 316 on the instrument body 312. The proximal point 316 of the shape sensor 314 may be movable with the instrument body 312, and the location of the proximal point 316 with respect to a desired reference frame may be known (e.g., via a tracking sensor or other tracking device). The shape sensor 314 may measure a shape from the proximal point 316 to another point, such as a distal end 318 of the elongate device 310. The shape sensor 314 may be aligned with the elongate device 310 (e.g., provided within an interior channel or mounted externally). In some examples, the shape sensor 314 may optical fibers used to generate shape information for the elongate device 310.

[0069] In some examples, position sensors (e.g., EM sensors) may be incorporated into the medical instrument 304. A series of position sensors may be positioned along the flexible elongate device 310 and used for shape sensing. Position sensors may be used alternatively to the shape sensor 314 or with the shape sensor 314, such as to improve the accuracy of shape sensing or to verify shape information.

[0070] Elongate device 310 may house cables, linkages, or other steering controls that extend between the instrument body 312 and the distal end 318 to controllably bend the distal end 318. In some examples, at least four cables are used to provide independent up-down steering to control a pitch of distal end 318 and left- right steering to control a yaw of distal end 318. The instrument body 312 may include drive inputs that removably couple to and receive power from drive elements, such as actuators, of a manipulator assembly.

[0071] The instrument body 312 may be coupled to an instrument carriage 306. The instrument carriage 306 may be mounted to an insertion stage 308 that is fixed within the surgical environment 300. Alternatively, the insertion stage 308 may be movable but have a known location (e.g., via a tracking sensor or other tracking device) within surgical environment 300. Instrument carriage 306 may be a component of a manipulator assemblyIntuitive Docket No.: P07036-WO Attorney Docket No.: 33685 / 70822 PC (e.g., manipulator assembly 102) that couples to the medical instrument 304 to control insertion motion (e.g., motion along an insertion axis A) and / or motion of the distal end 318 of the elongate device 310 in multiple directions, such as yaw, pitch, and / or roll. The instrument carriage 306 or insertion stage 308 may include actuators, such as servomotors, that control motion of instrument carriage 306 along the insertion stage 308.

[0072] A sensor device 320, which may be a component of the sensor system 108, may provide information about the position of the instrument body 312 as it moves relative to the insertion stage 308 along the insertion axis A. The sensor device 320 may include one or more resolvers, encoders, potentiometers, and / or other sensors that measure the rotation and / or orientation of the actuators controlling the motion of the instrument carriage 306, thus indicating the motion of the instrument body 312. In some embodiments, the insertion stage 308 has a linear track as shown in FIGS. 3A and 3B. In some embodiments, the insertion stage 308 may have curved track or have a combination of curved and linear track sections.

[0073] FIG. 3 A shows the instrument body 312 and the instrument carriage 306 in a retracted position along the insertion stage 308. In this retracted position, the proximal point 316 is at a position L0 on the insertion axis A. The location of the proximal point 316 may be set to a zero value and / or other reference value to provide a base reference (e.g., corresponding to the origin of a desired reference frame) to describe the position of the instrument carriage 306 along the insertion stage 308. In the retracted position, the distal end 318 of the elongate device 310 may be positioned just inside an entry orifice of patient P. Also in the retracted position, the data captured by the sensor device 320 may be set to a zero value and / or other reference value (e.g., 1=0). In FIG. 3B, the instrument body 312 and the instrument carriage 306 have advanced along the linear track of insertion stage 308, and the distal end 318 of the elongate device 310 has advanced into patient P. In this advanced position, the proximal point 316 is at a position LI on the insertion axis A. In some examples, the rotation and / or orientation of the actuators measured by the sensor device 320 indicating movement of the instrument carriage 306 along the insertion stage 308 and / or one or more position sensors associated with instrument carriage 306 and / or the insertion stage 308 may be used to determine the position LI of the proximal point 316 relative to the position L0. In some examples, the position LI may further be used as an indicator of the distance or insertion depth to which the distal end 318 of the elongate device 310 is inserted into the passageway(s) of the anatomy of patient P.

[0074] An example medical system 400 is shown in FIGS. 4A-4F. The medical system 400 includes a flexible medical device 402 that is configured to be inserted within a patient anatomy. For example, the flexible medical device 402 can be configured to be inserted intoIntuitive Docket No.: P07036-WO Attorney Docket No.: 33685 / 70822 PC the lungs or other cavities of a patient, such as pursuant to a urological or liver catheter biopsy. The medical system 400 further includes an ultrasound sensor 404 coupled to the flexible medical device 402. The ultrasound sensor 404 is configured to receive ultrasound waves emitted from an ultrasound transducer 406 external to the patient anatomy when the ultrasound sensor 404 is within the patient anatomy. In other words, the ultrasound transducer 406 is operated outside of the patient, such as along a skin surface of a patient.

[0075] A control system 408 is coupled to the ultrasound sensor 404 and is configured to generate an image based on a signal received from the ultrasound sensor 404. The medical system 400 can further include a user interface 410. The user interface 410 allows a user to monitor the operation of the medical system 400 and a current status of the procedure. Further, the control system 408 can provide information to the user via the user interface 410. In some examples, the system 400 includes the ultrasound transducer 406 and the control system 408 is operably coupled to the ultrasound transducer 406 to control the operation thereof (i.e., selectively direct ultrasound waves into a patient).

[0076] The flexible medical device 402 can have any suitable form. In one example, the flexible medical device 402 is an elongate device (e.g., with an elongate shaft 412) and the ultrasound sensor 404 is coupled to a distal end 414 of the elongate flexible medical device 402. With this example, the ultrasound sensor 404 can include connections (e.g., wires and the like) that extend proximally along or within the elongate flexible medical device 402.

[0077] One example configuration for the flexible elongate medical device 402 is shown in FIG. 4B, the distal end 414 of the flexible elongate medical device 402 includes a distally facing end surface 416. The ultrasound sensor 404 is exposed along the end surface 416, such that the ultrasound sensor 404 can receive ultrasound waves from the ultrasound transducer 406 within a patient when the ultrasound transducer 406 is external to the patient. The ultrasound sensor 404 can be a single sensor or can be an array of a plurality of sensors. For example, as shown in FIG. 4B, the ultrasound sensor 404 includes a plurality of sensors aligned in a linear or phased array 418 across the end surface 416. The linear array 418 can include any desired number of sensors, such as at least two sensors, at least three sensors, at least four sensors, at least five sensors, at least ten sensors, at least fifteen sensors, and so forth.

[0078] Data from the linear array 418 can be utilized to generate an image, such as that shown in the example of FIG. 4C. The example image has a sector shape with the linear array 418 as an origination point. Other suitable configurations can produce linear B-can images. Target tissue T is shown in the image in a different shade relative to background.Intuitive Docket No.: P07036-WO Attorney Docket No.: 33685 / 70822 PC

[0079] A second example configuration for the flexible elongate medical device 402 is shown in FIG. 4D. In this example, the distal end 414 of the flexible elongate medical device 402 includes a needle 420. The needle 420 is coupled to the elongate shaft 412. The ultrasound sensor 404 is coupled to the needle 420, (e.g., exposed along a side or at a tip of the needle 420), such that the ultrasound sensor 404 can receive ultrasound waves from the ultrasound transducer 406 within a patient when the ultrasound transducer 406 is external to the patient. The ultrasound sensor 404 can be a single sensor or can be an array of a plurality of sensors. In one example, the needle 420 includes a single ultrasound sensor 404. In another example, the needle 420 includes a plurality of ultrasound sensors 404, such as two, three, four, or more.

[0080] In a third example, the flexible elongate medical device 402 is a stylet configured to be inserted into another device, such as a steerable device discussed below, and the ultrasound sensor 404 is coupled to a distal end of the stylet (e.g., exposed along a side or at a tip of the stylet), such that the ultrasound sensor 404 can receive ultrasound waves from the ultrasound transducer 406 within a patient when the ultrasound transducer 406 is external to the patient. The ultrasound sensor 404 can be a single sensor or can be an array of a plurality of sensors.

[0081] In some examples, the medical system 400 includes a sensor 422 associated with the flexible medical device 402. The sensor 422 can be any suitable sensor or combination of sensors. For example, the sensor 422 can be a shape sensor (e.g., a fiber optic shape sensor) or an electromagnetic (EM) sensor. The sensor 422 is configured to generate sensor data indicating a position of the flexible medical device 402 and / or an orientation of the flexible medical device 402. The sensor 422 is coupled to the control system 408 to provide the sensor data thereto. The control system 408 determines position information from the sensor data to aid a user during a procedure, such as by locating or providing aid to locate the ultrasound sensor 404 within the patient and / or locating or providing aid to locate target tissue (e.g., a lesion) within the patient.

[0082] As can be appreciated, in order for the ultrasound sensor 404 to generate an image, the ultrasound transducer 406 has to be located correctly with respect to the ultrasound sensor 404 and any intervening anatomy and / or space, as well as oriented to emit ultrasound waves in the direction of the ultrasound sensor 404. The control system 408 can aid in the positioning and / or orientation of the ultrasound transducer 406 based on the position information extrapolated from the sensor data.

[0083] In a first example, the control system 408 outputs the position information on a display 424 of the user interface 410. This can take the form of an area overlapping patient anatomy providing an indication of where the ultrasound transducer 406 should be located. InIntuitive Docket No.: P07036-WO Attorney Docket No.: 33685 / 70822 PC another form, the control system 408 can display a cone with reference to patient anatomy to indicate an orientation for the ultrasound transducer 406 that would help locate the ultrasound sensor 404 within the patient. In this example, the tip of the cone provides position information for the ultrasound transducer 406, while the direction and size of the cone as it travels through the patient anatomy provides orientation information for the ultrasound transducer 406. With this information, a user can manually position and orient the ultrasound transducer 406 external to the patient.

[0084] In a second example, as shown in FIG. 4E, the medical system 400 includes a robotic arm 426 having the ultrasound transducer 406 coupled thereto. The robotic arm 426 can have any suitable form, including having one or more links coupled by joints, allowing the robotic arm 426 to move relative to a patient. In this example, the control system 408 controls the movement of the robotic arm 426, including a mount 428 for the ultrasound transducer 406 to orient and position the ultrasound transducer 406 relative to patient anatomy. The robotic arm 426 and / or mount 428 can include one or more degrees-of-freedom to move the ultrasound transducer 406 relative to the patient. For example, the degrees-of-freedom can include pitch, yaw, rotation, insertion, x-axis movement, y-axis movement, z-axis movement, and so forth in any suitable configuration.

[0085] With this configuration, the control system 408 moves the robotic arm 426 and / or mount 428 to position and / or orient the ultrasound transducer 406 based on the position information, to direct ultrasound waves to the ultrasound sensor 404 within the patient. In examples consistent with the medical system 100 described above, the robotic arm 426 and / or mount 428 can be the manipulator system 102 or be part of the manipulator system 102.

[0086] As can be appreciated, the position and orientation of the ultrasound transducer 406 relative to the patient controls the area within the patient that the ultrasound waves are directed to, with intervening anatomic structures and distance impacting the reception of the ultrasound waves at the ultrasound sensor 404. Accordingly, the position and orientation of the ultrasound transducer 406 can be determined to avoid intervening anatomic structures of the patient, as well as locate the ultrasound transducer 406 and the ultrasound sensor 404 at a distance relative to one another sufficient for desirable reception of the ultrasound waves. This determination can be based at least partially on the position information (e.g., location and orientation provided by sensor data) of the ultrasound sensor 404 within the patient. A user can also or alternatively reference CT scan data, as well as other patient data for the determination.

[0087] In the example of FIG. 4D discussed above, the ultrasound sensor 404 is coupled to the needle 420 and, as such, the position and orientation of the needle 420 and the ultrasoundIntuitive Docket No.: P07036-WO Attorney Docket No.: 33685 / 70822 PC sensor 404 coupled thereto directly impacts the direction from which the ultrasound sensor 404 can have maximum receiving gain. The determination of the position and orientation of the ultrasound transducer 406 can include positioning and orienting the ultrasound transducer 406 so that the ultrasound waves emitted from the ultrasound transducer 406 are intended to achieve the maximum receiving gain of the ultrasound sensor 404. For example, an exciting transducer (e.g., ultrasound transducer 406) excites a planar slice in the body of a patient, while a receiving transducer (e.g., the ultrasound sensor 404) has a spatial beam profile that determines from which directions and positions the receiving transducer can successfully receive signals. The overlap of the planar slice and the spatial beam profile of the ultrasound sensor 404 produce an appreciable signal.

[0088] The control system 408 can also utilize the position information to determine a position of target tissue within the image. For example, in the event the image generated from the ultrasound sensor 404 includes target tissue, such as a lesion, the control system 408 can utilize the sensor data to correlate the position of the target tissue with the position of the sensor 422. For example, the correlation can include the position of the flexible medical device 402 along with an offset in a particular direction indicated by the orientation of the flexible medical device 402 to identify the location of the target tissue. An orientation associated with the ultrasound sensor 404 can be utilized to provide a direction value for the image. For example, the direction value can be a pointing direction of the needle 420 of the example of FIG. 4D or a direction orthogonal to the end surface 416 of the example of FIG. 4B. This location can also be cross-referenced with CT scan data to update a patient reference for a procedure.

[0089] In another approach, the relationship of the sensor 422 relative to the robotic arm 426, the relationship of the image based on signals from the transducer 406 relative to the robotic arm 426, and the position information from the sensor 422 can be utilized to determine a location of target tissue within the image.

[0090] In one example, the position data of the sensor 422 associated with the flexible elongate device 402 is registered to an anatomical reference frame of the patient (e.g., CT scan data), so that the position of the flexible elongate device 402 and the ultrasound sensor 404 is known within the anatomical reference frame of the patient. Further, the location of objects within the image generated from the data of the ultrasound sensor 404 is known relative to a location of the ultrasound sensor 404. For example, the image is generated with the ultrasound sensor 404 centrally disposed along an edge thereof, such that the distance of an object (e.g., target tissue) shown in the image from the ultrasound sensor 404 can be determined. Accordingly, using this information, the location of the object can be correlated to theIntuitive Docket No.: P07036-WO Attorney Docket No.: 33685 / 70822 PC anatomical reference frame of the patient. In another example, images can be segmented to allow a three dimensional depicture of various structures of interest within a patient’s body.

[0091] As described above with regard to the example of FIG. 4B, the linear array 418 of ultrasound sensors 404 produces an image, such similar to the one shown in FIG. 4C, that can include a clearly defined target object, such as a lesion. Accordingly, the linear array 418 can be utilized as part of the above analysis to provide an image, as well as the position data associated with the linear array 418 to accurately locate target tissue within a patient.

[0092] In one example as shown in FIG. 4A, the sensor 422 can be coupled to (e.g., mounted, fixed, extending within, embedded, etc.) the flexible medical device 402. With this configuration, the flexible medical device 402 can be delivered or inserted into a patient for a procedure, either as the only device within the patient or with one or more additional devices.

[0093] In an additional or alternative example, the sensor 422 can be coupled to a device interacting with the flexible medical device 402. As shown in FIG. 4F, the system 400 can include a steerable device 430 (e.g., catheter, endoscope, and so forth) defining a working channel 432 sized to receive the flexible medical device 402 therethrough. The steerable device 430 is operable to be manipulated by a user and / or robotic manipulator system to maneuver within a patient to a target location. In some examples, the steerable device 430 can include an articulable body portion that can be maneuvered about one axis (e.g., pitch or yaw), about two axes (e.g., pitch and yaw), or more.

[0094] The flexible medical device 402 can be sized to position the ultrasound sensor 404 at the distal opening of the working channel 432 (i.e., within the steerable device 430). In an alternative example, the flexible medical device 402 can be sized to extend distally of the steerable device 430 (i.e., through the working channel 432). In order to determine how far the flexible medical device 402 extends beyond the steerable device 430, the system 400 includes an extension measurement device 434. The extension measurement device 434 can have any suitable form. For example, the flexible medical device 402 can include markings on a proximal end thereof that align with the steerable device 430 to provide an indication of an insertion depth. In other examples, inductance tracking, insertion motor encoder analysis, and / or the data from the sensor 422 can be utilized to track an insertion depth.

[0095] In examples with the steerable device 430, the steerable device 430 can include the sensor 422 and the sensor data generated by the sensor 422 (e.g., position / orientation) can be correlated to the flexible medical device 402 by virtue of the flexible medical device 402 being disposed within the steerable device 430.Intuitive Docket No.: P07036-WO Attorney Docket No.: 33685 / 70822 PC

[0096] As discussed above, the sensor 422 can be a shape or EM sensor, such that the control system 408 is configured to determine and display position data for the steerable device 430 based on data from the shape sensor. In some examples, the control system 408 overlays the sensor data from the shape sensor (e.g., location and orientation data) with computed tomography (CT) scan data of the patient to provide an indication of location and pointing direction of the flexible medical device 402 to locate target tissue. Additionally, in examples with the external transducer 406 coupled to the robotic arm 426, the control system can be configured to operate the robotic arm 426 so that the external transducer 406 tracks movement of the steerable device 430 to locate the ultrasound sensor 404 within the patient.

[0097] In additional or alterative examples, fluoroscopy is performed on the patient to provide real-time fluoroscopy images of the patient. When utilized, the control system 408 displays the fluoroscopy images on the display 424 of the user interface 410. The real-time fluoroscopy images can aid a user to identify a location of the flexible medical device 402 and the ultrasound sensor 404 coupled thereto. The user can utilize the fluoroscopy images to orient and locate the external transducer 406 relative to the patient to direct ultrasound waves to the ultrasound sensor 404. In one example, the control system 408 is configured to display overlapped offset (e.g., 90 degree offset) fluoroscopy images, which provides a three dimensional aid for the orientation and location of the external transducer 406.

[0098] With the above configuration, the medical system 400 can be utilized pursuant to a biopsy procedure. In the event the flexible medical device 402 is delivered to a target location within a patient, the ultrasound image can be utilized to confirm the location of target tissue, such as a lesion. Further, the location can be confirmed relative to CT scan data based on sensor data associated with the flexible medical device 402. Thereafter, a biopsy needle can be deployed to the location to take a sample. If the ultrasound image does not show the target tissue, the flexible medical device 402 can be moved around within a patient to generate a series of images to find the target tissue. The location of the flexible medical device 402 can also be confirmed through sensor data to determine if the flexible medical device 402 is in the correct location and / or if there is divergence from the CT scan data. As discussed above, the sensor data can also be utilized to locate the ultrasound sensor 404 within the patient to generate the ultrasound images and determine the location shown in the images.

[0099] FIG. 5 illustrates an ultrasound imaging method 500 according to some embodiments. The method 500 is illustrated as a set of operations or processes 502 through 514. Not all of the illustrated processes may be performed in all embodiments of method 500. Additionally, one or more processes that are not expressly illustrated in FIG. 5 may be includedIntuitive Docket No.: P07036-WO Attorney Docket No.: 33685 / 70822 PC before, after, in between, or as part of the processes 502 through 514. Processes may also be performed in different orders. In some embodiments, one or more of the processes 502 through 514 may be implemented, at least in part, in the form of executable code stored on non-transitory, tangible, machine-readable media that when run by one or more processors (e.g., the processors of a controller) may cause the one or more processors to perform one or more of the processes. In one or more embodiments, the processes 502 through 514 may be performed by a controller (e.g., control system 112, 408).

[0100] In process 502, a flexible medical device (e.g., flexible medical device 402) is inserted into a working channel (e.g., working channel 432) of a steerable catheter (e.g., steerable device 430).

[0101] In process 504, sensor data is generated with a sensor (e.g., sensor 422) associated with the flexible medical device, the sensor data indicating at least one of a position of the flexible medical device or an orientation of the flexible medical device. In process 506, position information for an ultrasound transducer (e.g., ultrasound transducer 406) is determined based on the sensor data. In process 508, the position information and / or fluoroscopy images are provided to a user interface (e.g., user interface 410) to help a user locate an ultrasound sensor (e.g., ultrasound sensor 404) within a patient or a robotic arm (e.g., robotic arm 426) is moved to control at least one of a position or orientation of the ultrasound transducer based on the position information.

[0102] In process 510, a signal is received from the ultrasound sensor corresponding to ultrasound waves generated by the ultrasound transducer external to the patient and, in process 512, an image is generated based on the signal. In process 514, a position of target tissue within the image is determined based at least partially on the sensor data.

[0103] One or more components of the embodiments discussed in this disclosure, such as control system 112, may be implemented in software for execution on one or more processors of a computer system. The software may include code that when executed by the one or more processors, configures the one or more processors to perform various functionalities as discussed herein. The code may be stored in a non-transitory computer readable storage medium (e.g., a memory, magnetic storage, optical storage, solid-state storage, etc.). The computer readable storage medium may be part of a computer readable storage device, such as an electronic circuit, a semiconductor device, a semiconductor memory device, a read only memory (ROM), a flash memory, an erasable programmable read only memory (EPROM); a floppy diskette, a CD-ROM, an optical disk, a hard disk, or other storage device. The code may be downloaded via computer networks such as the Internet, Intranet, etc. for storage on theIntuitive Docket No.: P07036-WO Attorney Docket No.: 33685 / 70822 PC computer readable storage medium. The code may be executed by any of a wide variety of centralized or distributed data processing architectures. The programmed instructions of the code may be implemented as a number of separate programs or subroutines, or they may be integrated into a number of other aspects of the systems described herein. The components of the computing systems discussed herein may be connected using wired and / or wireless connections. In some examples, the wireless connections may use wireless communication protocols such as Bluetooth, near-field communication (NFC), Infrared Data Association (IrDA), home radio frequency (HomeRF), IEEE 802.11, Digital Enhanced Cordless Telecommunications (DECT), and wireless medical telemetry service (WMTS).

[0104] Various general-purpose computer systems may be used to perform one or more processes, methods, or functionalities described herein. Additionally or alternatively, various specialized computer systems may be used to perform one or more processes, methods, or functionalities described herein. In addition, a variety of programming languages may be used to implement one or more of the processes, methods, or functionalities described herein.

[0105] While certain embodiments and examples have been described above and shown in the accompanying drawings, it is to be understood that such embodiments and examples are merely illustrative and are not limited to the specific constructions and arrangements shown and described, since various other alternatives, modifications, and equivalents will be appreciated by those with ordinary skill in the art.

Claims

Intuitive Docket No.: P07036-WO Attorney Docket No.: 33685 / 70822 PC What is claimed is:

1. A medical system comprising:a flexible medical device configured to be inserted within a patient anatomy;an ultrasound sensor coupled to the flexible medical device and configured to receive ultrasound waves emitted from an ultrasound transducer external to the patient anatomy when the ultrasound sensor is within the patient anatomy; anda control system coupled to the ultrasound sensor and configured to generate an image based on a signal received from the ultrasound sensor.

2. The medical device of claim 1 , wherein the ultrasound sensor comprises a plurality of ultrasound sensors.

3. The medical system of claim 1, further comprising the ultrasound transducer, the control system coupled to the ultrasound transducer to control the operation thereof.

4. The medical system of claim 1, further comprising a sensor associated with the flexible medical device, the sensor configured to generate sensor data indicating at least one of a position of the flexible medical device or an orientation of the flexible medical device.

5. The medical system of claim 4, wherein the sensor comprises a shape sensor.

6. The medical system of claim 4, wherein the control system configured to determine position information for the ultrasound transducer based on the sensor data.

7. The medical system of claim 6, further comprising a user interface; and wherein the control system is configured to provide the position information to the user interface.

8. The medical system of claim 6, further comprising a robotic arm having the ultrasound transducer coupled thereto; and wherein the control system is configured to move to robotic arm to dispose the ultrasound transducer in at least one of a position or orientation based on the position information.Intuitive Docket No.: P07036-WO Attorney Docket No.: 33685 / 70822 PC 9. The medical system of claim 4, wherein the control system is configured to determine a position of target tissue within the image based at least partially on the sensor data.

10. The medical system of any one of claims 1 to 9, wherein the medical device comprises an elongate device, and the ultrasound sensor is coupled to a distal end of the elongate device.

11. The medical system of claim 10, wherein the elongate device comprises an elongate shaft with a needle coupled to an end of the elongate shaft; and the ultrasound sensor is coupled to the needle.

12. The medical system of claim 10, wherein the elongate device comprises a stylet; and the ultrasound sensor is coupled to a distal end of the stylet.

13. The medical system of claim 10, wherein the distal end of the elongate device includes a distally facing end surface; and the ultrasound sensor is exposed along the end surface.

14. The medical system of claim 13, wherein the ultrasound sensor comprises a plurality of sensors aligned in a linear array across the end face.

15. The medical system of claim 10, further comprising a steerable catheter defining a working channel, the elongate device configured to be received within the working channel.

16. The medical system of claim 15, wherein the steerable catheter includes a shape sensor, the control system configured to display position data for the steerable catheter based on data from the shape sensor.

17. The medical system of claim 16, wherein the control system is configured overlay shape data from the shape sensor with computed tomography (CT) scan data to provide an indication of location and pointing direction to locate target tissue.

18. The medical system of claim 16, further comprising a robotic manipulator arm, the external transducer being coupled to the robotic manipulator arm; and wherein the control system is configured to operate the robotic manipulator arm so that the external transducer tracks movement of the steerable catheter to locate the ultrasound sensor.Intuitive Docket No.: P07036-WO Attorney Docket No.: 33685 / 70822 PC19. The medical system of any one of claims 1 to 9, wherein the control system is configured to display fluoroscopy images to a user to aid with the orientation and location of the external transducer.

20. An ultrasound imaging method, the method comprising:receiving, by a control system, a signal from an ultrasound sensor located within a patient anatomy corresponding to ultrasound waves generated by an ultrasound transducer external to the patient; andgenerating, by the control system, an image based on the signal.

21. The method of claim 20, further comprising generating sensor data with a sensor associated with a flexible medical device having the ultrasound sensor coupled thereto, the sensor data indicating at least one of a position of the flexible medical device or an orientation of the flexible medical device.

22. The method of claim 21, wherein generating sensor data comprises generating shape sensor data.

23. The method of claim 21, further comprising determining position information for the ultrasound transducer based on the sensor data.

24. The method of claim 23, further comprising providing the position information to a user interface to help a user locate the ultrasound sensor.

25. The method of claim 23, further comprising moving to robotic arm to control at least one of a position or orientation of the ultrasound transducer based on the position information.

26. The method of claim 21, further comprising determining a position of target tissue within the image based at least partially on the sensor data.

27. The method of any one of claims 20 to 26, wherein the medical device comprises an elongate device; and further comprising inserting the elongate device into a working channel of a steerable catheter.Intuitive Docket No.: P07036-WO Attorney Docket No.: 33685 / 70822 PC28. The method of claim 27, further comprising displaying position data for the steerable catheter based on data from a shape sensor of the steerable catheter.

29. The method of claim 28, wherein displaying position data for the steerable catheter comprises overlaying shape data from the shape sensor with computed tomography (CT) scan data to provide an indication of location and pointing direction to locate target tissue.

30. The method of claim 28, further comprising operating a robotic manipulator arm so that the external transducer coupled thereto tracks movement of the steerable catheter to locate the ultrasound sensor.

31. The method of any one of claims 20 to 26, further comprising displaying fluoroscopy images to a user to aid with the orientation and location of the external transducer.

Images