Medical tool with signal window and methods of use

Abstract

A system may comprise a flexible elongate device including one or more signal transmitters and a tool configured to extend from a distal end of the flexible elongate device. The tool may comprise a body portion defining a window and a localization sensor coupled to the body portion. At least a portion of the localization sensor is exposed by the window to receive a signal from the one or more signal transmitters through the window. The system may also comprise a control system configured to determine a location of the tool based on the signal received by the localization sensor from the one or more signal transmitters.

Description

MEDICAL TOOL WITH SIGNAL WINDOW AND METHODS OF USECROSS-REFERENCED APPLICATIONS

[0001] This application claims priority to and benefit of U.S. Provisional Application No. 63 / 584,399 filed September 21, 2023 and entitled “Medical Tool with Signal Window and Methods of Use,” which is incorporated by reference herein in its entirety.FIELD

[0001] The present disclosure is related to systems and methods for localizing a medical tool that includes a signal window.BACKGROUND

[0002] 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, an operator may insert a minimally invasive medical instrument (including surgical, diagnostic, therapeutic, and / or biopsy instruments) to reach a target tissue location. One such minimally invasive technique is to use a flexible elongate device, such as a flexible catheter, bronchoscope, or endoscope, that can be inserted into anatomic passageways and navigated toward a region of interest within the patient anatomy. Various medical tools may be extended from the flexible elongate device. Improved systems and methods are needed for localizing the medical tools relative to the flexible elongate device and anatomic regions in which the medical tool is extended.SUMMARY

[0003] 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.

[0004] In some examples, a system may comprise a flexible elongate device including one or more signal transmitters and a tool configured to extend from a distal end of the flexible elongate device. The tool may comprise a body portion defining a window and a localization sensor coupledto the body portion. At least a portion of the localization sensor is exposed by the window to receive a signal from the one or more signal transmitters through the window. The system may also comprise a control system configured to determine a location of the tool based on the signal received by the localization sensor from the one or more signal transmitters.

[0005] In some examples, a medical tool may comprise a body portion with an acoustic window defined in the body portion and an optical fiber localization sensor extending into the acoustic window. The acoustic window is configured to allow through passage of an ultrasound signal and wherein the body portion around the acoustic window is configured to absorb the ultrasound signal.

[0006] In some examples, a method may comprise localizing a tool relative to one or more ultrasound transducers supported by an instrument to which the tool is movably coupled and localizing the one or more ultrasound transducers relative to a reference frame. Based on the localization of the tool to the one or more ultrasound transducers, the tool may be localized relative to the reference frame.

[0007] 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

[0008] FIG. 1 illustrates an example of a flexible elongate device in a patient anatomy near a target tissue, according to some examples.

[0009] FIG. 2 illustrates a flexible elongate device extended within an anatomic passage, according to some examples.

[0010] FIG. 3A illustrates an end view of a flexible elongate device, according to some examples.

[0011] FIG. 3B illustrates an end view of a flexible elongate device, according to some examples.

[0012] FIG. 3C illustrates a side view of a flexible elongate device, according to some examples.

[0013] FIG. 4A illustrates a top view of a medical tool including a window, according to some examples.

[0014] FIG. 4B illustrates a side view of a medical tool including an elongated implement, according to some examples.

[0015] FIG. 5 is a flowchart illustrating a method for localizing a medical tool, according to some examples.

[0016] FIG. 6 is a flowchart illustrating a method for localizing a medical tool relative to a signal transmitter, according to some examples.

[0017] FIG. 7 A illustrates a top view of a medical tool including a window, according to some examples.

[0018] FIG. 7B illustrates a top view of a medical tool including a window, according to some examples.

[0019] FIG. 7C illustrates a top view of a medical tool including a window, according to some examples.

[0020] FIG. 7D illustrates a side view of a medical tool including a window, according to some examples.

[0021] FIG. 8A illustrates a side view of a medical tool including a window, according to some examples.

[0022] FIG. 8B illustrates an opposite side view of the medical tool of FIG. 8A.

[0023] FIG. 9 A illustrates a top view of a medical tool, according to some examples.

[0024] FIG. 9B, 9C, and 9D illustrate cross-sectional views of the medical tool of FIG. 9A.

[0025] FIG. 10A illustrates a top view of a medical tool, according to some examples.

[0026] FIG. 10B, 10C, and 10D illustrate cross-sectional views of the medical tool of FIG. 10A.

[0027] FIG. 11 is a simplified diagram of a medical system, according to some examples.

[0028] FIG. 12A is a simplified diagram of a medical instrument system, according to some examples.

[0029] FIG. 12B is a simplified diagram of a medical instrument including a medical tool within a flexible elongate device, according to some examples.

[0030] 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

[0031] The techniques discussed herein may be used to enhance localization of medical tools, including biopsy tools or other types of tools, and their use in medical procedures. In some examples, a medical tool location may be tracked and localized relative to signal transmitters that may also be used for other sensing or imaging modalities. The signal transmitters may be registered to a reference frame (e.g., an anatomical reference frame) and thus the medical tool, by virtue of being localized relative to the signal transmitters, may also be localized relative to the reference frame. Although some of the signal transmitters described herein are ultrasound signal transmitters that may also be used for image generation, it is contemplated that the systems and methods described herein may be applied using other types of signal transmitters.

[0032] FIG. 1 illustrates a medical instrument system 100 extending within branched anatomic passageways or airways 102 of an anatomical structure 104. In some examples the anatomic structure 104 may be a lung and the passageways 102 may include the trachea 106, primary bronchi 108, secondary bronchi 110, and tertiary bronchi 112. The anatomic structure 104 has an anatomical frame of reference (XA, YA, ZA). A distal end portion 118 of the medical instrument system 100 may be advanced into an anatomic opening (e.g., a patient mouth) and through the anatomic passageways 102 to perform a medical procedure, such as a biopsy, ablation, electroporation, or other type of diagnostic or therapeutic procedure, at or near a target tissue 113.

[0033] As shown in FIG. 2 a medical instrument system 150 (e.g., the elongated medical instrument system 100) may include a flexible elongate device 152 extendable through the anatomic passageway 102. In some examples, the flexible elongate device 152 may be or may be integrated into a robotically-controlled system and / or a manually-controlled system that controls articulation and insertion / retraction of the flexible elongate device 152. An example of a medical instrument system that is bendable and steerable in multiple degrees of freedom is described below in FIGS. 12A and 12B (e.g., system 700). The flexible elongate device 152 may include avisualization system 154 and an imaging localization system 156. In some examples, the visualization system 154 may include an (c.g., visible light) optical imaging system 158 positioned at a distal end portion of the flexible elongate device 152. In some examples, the visualization system 154 may also or alternatively include an imaging device 161 that generates images based on transmitting signals and receiving the signals reflected off the environment (also referred to as a “signal-based imaging device”), such as an ultrasound or photoacoustic imaging device. The imaging device 161 may be located at a distal end portion 163 of the flexible elongate device 152 or in one or more other locations of the flexible elongate device 152. The imaging device 161 may generate image data for a field of view 159. The optical imaging system 158 may generate image data for a different field of view. An ultrasound imaging device may include transducer arrays that may be comprised of a plurality of transducers of any size or shape, as described in greater detail below. For ultrasound imaging, contact between the flexible elongate device 152 and a wall 157 of the anatomic passageway 102 may be required or may improve the quality of the imaging data. For example, if the imaging device 161 includes an ultrasound transducer, contact between the flexible elongate device 152 and the wall 157 may eliminate air gaps and promote the effective transmission of the ultrasound signal and the generation of a clear’ image.

[0034] In some examples, the imaging localization system 156 may include, for example, an optical fiber shape sensor, an electromagnetic (EM) sensor, or plurality of EM sensors positioned at a known location relative to the visualization system 154 to track the position and orientation of all or parts of the visualization system 154. The imaging localization system 156 may be used to track the configuration, including position and / or orientation, of the distal end portion 163 of the flexible elongate device 152, including the imaging device 161, in multiple (e.g., six) degrees of freedom. If the imaging device 161, or components of the imaging device 161, are located at other portions of the flexible elongate device 152, the imaging localization system 156 may be used to track the configuration of the other portions. Thus, the localization data from the imaging localization system 156 may be used to determine the configuration of the image data from the imaging device 161 in three-dimensional space. In one example, an optical fiber forms a shape sensor for determining the shape of the flexible elongate device 152. The optical fiber or a portion of the optical fiber may be fixed at the distal end portion 163 of the flexible elongate device 152 or at a known location relative to the imaging device 161 to provide localization data, including position and / or orientation data, for the imaging device 161. With a distal end of the optical fibershape sensor fixed at a constant offset to the imaging device 161 , the position and orientation of the imaging device 161 may be determined by the measured shape of the sensor. A proximal end of the shape sensor may be fixed or known relative to a robot-assisted medical system. In other examples, if the flexible elongate device is manually manipulated, the proximal end of the shape sensor may be fixed to the patient body or another fixed or tracked location near’ the patient.

[0035] A shape sensor, such as an optical fiber bend sensor, may include Fiber Bragg Gratings (FBGs) that 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 are described in U.S. Patent Application No. 11 / 180,389 (filed July 13, 2005) (disclosing “Fiber optic position and shape sensing device and method relating thereto”); U.S. Patent Application No. 12 / 047,056 (filed on Jul. 16, 2004) (disclosing “Fiber-optic shape and relative position sensing”); and U.S. Patent No. 6,389,187 (filed on Jun. 17, 1998) (disclosing “Optical Fiber Bend Sensor”), 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. In some examples, the shape of the flexible elongate device 152 may be determined using other techniques. For example, a history of the distal end pose of flexible elongate device 152 can be used to reconstruct the shape of the flexible elongate device 152 over the interval of time. In some embodiments, a shape sensor may comprise a plurality of position sensors (such as electromagnetic position sensors) which collectively provide shape data regarding a shape of at least a portion of the flexible elongate device 152. Generally, a shape sensor as that term is used herein may provide any number of data points in any number of degrees of freedom including three or six degrees of freedom at a series of points monitored by the shape sensor along the length of the flexible elongate device 152.

[0036] In some examples, the flexible elongate device 152 may include a steering system 160, including control wires, cables, or other control apparatus to bend or steer a distal end portion of the flexible elongate device 152, which may include the visualization system 154. In some examples, the flexible elongate device 152 may also include a channel or passage 164 through which a tool 166 may be extended to emerge from a port 155 of the flexible elongate device 152 to engage the target tissue 113. The port 155 is shown in FIG. 2 as being a distal port defined at the distal end of the flexible elongate device 152. In other examples, the port 155 may be in otherplaces. For example, the port 155 may be a side port defined at a side wall near the distal end of the flexible elongate device 152. The tool 166 may be advanced, retracted, rotated, or otherwise moved relative to the flexible elongate device 152 by manual or robotic control. The tool 166 may include a localization sensor 167 used to facilitate position determination for the tool 166. The tool 166 may be, for example, a biopsy or tissue sampling tool, an ablation tool including a heated or cryo-probe, an electroporation tool, a forceps, a medication delivery device, a fiducial delivery device, or another type of diagnostic or therapeutic device. In some examples, the tool 166 may have a flexible shaft. The tool may include control wires or other control apparatus to bend or steer the direction of the tool, such as at an articulable portion of the tool distal to the flexible shaft.

[0037] FIG. 3 A illustrates an end view of a flexible elongate device 152A which may be the same or substantially similar to flexible elongate device 152 with differences as described. In this example, the imaging device 161 includes one or more signal transmitters 180. The signal transmitters 180 may be parts of transceivers that transmit and receive signals or may be transmitters that transmit but do not receive signals. The signal transmitters 180 may include, for example, a forward-facing linear array of ultrasound transducer elements. In some examples, the signal transmitters 180 may include a primary linear array of transducer elements 183 and at least one auxiliary transducer element 185 spaced away from the primary linear array. Whereas the linear array may track the position of a localization sensor 167 in a single plane, adding a spaced apart auxiliary transducer element may provide three-dimensional position information via triangulation of the localization sensor 167. In some examples the auxiliary transducer may be spaced apart and located on the flexible elongate device 152, and in some examples, the auxiliary transducer may be spaced apart on another device, which may be located inside or outside of the patient anatomy. The other device may be a different flexible elongate device (e.g., a catheter, endoscope, bronchoscope, etc.), a medical tool, an ultrasound device, an imaging device (e.g., an endoscope, a fluoroscopic imaging device, a cone beam computed tomography (CBCT) device, a tomosynthesis device, etc.), a robotic arm, or some other type of device with an auxiliary transducer element.

[0038] FIG. 3B illustrates an end view of a flexible elongate device 152B which may be the same or substantially similar to flexible elongate device 152 with differences as described. In this example, the imaging device 161 includes one or more signal transmitters 182. The signal transmitters 182 may include be just transmitters or may be components of transceivers. The signaltransmitters 182 may include, for example, a forward-facing annular array of ultrasound transducer elements. An annular amay may provide tracking of the localization sensor 167 in thrcc- dimensions via triangulation of the localization sensor 167.

[0039] FIG. 3C illustrates a side view of a flexible elongate device 152C which may be the same or substantially similar to flexible elongate device 152 with differences as described. In this example, the imaging device 161 includes one or more signal transmitters 187. The signal transmitters 187 may include be just transmitters or may be components of transceivers. The signal transmitters 187 may include, for example, a side-facing of ultrasound transducer element or plurality of side-facing ultrasound transducer elements. Side-facing transducer elements may provide tracking of the localization sensor 167 in three-dimensions via triangulation of the localization sensor 167.

[0040] More generally, three or more signal transmitters may be spaced apart at different locations near the tool 166 to transmit signals to the localization sensor 167 located on the tool 166 to determine the three-dimensional position of the tool 166 relative to the signal transmitters. In various examples, signal transmitters (e.g., signal transmitters 180 / 182 / 187) may be used to generate an image as well as performing the tool localization. For example, with the tool localized, an image may be generated, using the signal transmitters, in a plane based on the location of the tool.

[0041] FIG. 4A illustrates a top view of a portion of a distal portion of a medical tool 190 (e.g., the medical tool 166) that may be extendable from, rotatable within, bendable relative to, or otherwise movable with respect to a flexible elongate device (e.g., flexible elongate device 152). The medical tool 190 may also be used with other types of medical instruments, including rigid elongate devices, robotic arms, etc. The medical tool 190 may include a tool body 192 (also referred to as a tool body portion) in which a localization sensor 194 (e.g., localization sensor 167) extends. In some examples, the localization sensor 194 may include an optical fiber that carries signals (e.g., acoustic signals) received from the transmitters between proximal and distal end portions of the medical tool 190. A window 196 may be formed at a distal end portion of the tool body 192. The window 196 may be an acoustic window that transmits signals, such as acoustic signals from an ultrasound transmitter while the surrounding tool body 192 may at least partially or fully absorb signals such as the acoustic signals. In some examples, the window 196 may be an aperture through a wall of the tool body 192. In other examples, the window 196 may be a regionin the wall of the tool body 192 that is formed from or filled by a different material than the material forming the wall, such as a material that is more capable of passing signals without attenuation or absorption than the material of the wall. In some examples, thermoplastics such as a polyether block amide may be used to fill the window. The localization sensor 194, such as at a distal end, may be exposed by the window 196 to receive signals generated by signal transmitters from multiple directions, such as signal transmitters carried by the flexible elongate device and / or other devices. The localization sensor is not limited to being an optical fiber, and can be any type of sensor that is capable of sensing acoustic signals, including an ultrasound receiver (e.g., either as separate receiver or as part of a transceiver), piezoelectric device, microphone, etc. Various examples of window shapes, localization sensors, and tool configurations are described below.

[0042] FIG. 4B illustrates a top view of a portion of a distal portion of a medical tool 270 (e.g., the medical tool 166) that may be extendable from, rotatable within, bendable relative to, or otherwise movable with respect to a flexible elongate device (e.g., flexible elongate device 152). The medical tool 270 may also be used with other types of medical instruments, including rigid elongate devices, robotic arms, etc. The medical tool 270 may include a tool member 272 through which a channel 271 extends. The medical tool 270 may also include an elongated implement 273 including a tool body 277 sized to extend within the channel 271 and, optionally, through an opening at the distal end of the channel 271 to an area distal of the tool member 272. In some examples, the tool member 272 may be a needle and the elongated implement may be a stylet. In this example, a localization sensor 274 (e.g., localization sensor 167) may extend within the tool body 277. In some examples, the localization sensor 274 may include an optical fiber that carries signals (e.g., acoustic signals) received from the transmitters between proximal and distal end portions of the medical tool 270. A window 16 may be formed at a distal end portion of the tool body 277. The window 276 may be an acoustic window that transmits signals, such as acoustic signals from an ultrasound transmitter while the surrounding tool body 277 may at least partially or fully absorb signals such as the acoustic signals. In some examples, the window 276 may be an aperture through a wall of the tool body 277. In other examples, the window 276 may be a region in the wall of the tool body 277 that is formed from or filled by a different material than the material forming the wall, such as a material that is more capable of passing signals without attenuation or absorption than the material of the wall. In some examples, thermoplastics such as a polyether block amide may be used to fill the window. The localization sensor 274, such as at a distal end,may be exposed by the window 276 to receive signals generated by signal transmitters from multiple directions, such as signal transmitters earned by the flexible elongate device and / or other devices. The localization sensor is not limited to being an optical fiber, and can be any type of sensor that is capable of sensing acoustic signals, including an ultrasound receiver (e.g., either as separate receiver or as pail of a transceiver), piezoelectric device, microphone, etc. Various examples of window shapes, localization sensors, and tool configurations are described below.

[0043] For some medical procedures, it may be beneficial to provide real time visualization of the medical tool positioned within or near- a target tissue. For example, a medical tool may be delivered within the imaging field view of view of an ultrasound imaging instrument for direct visualization of the tool into the target tissue. In other examples, the position and / or orientation of the tool may be outside of the imaging field of view, but real time visualization of the tool with respect to the imaged target tissue may still be useful. To determine the position and / or orientation of the tool with respect to imaged tissue, the tool may be localized with respect to the frame of reference of the imaged tissue, and the current and / or prior positions of the tool with respect to the imaged tissue may be marked or displayed.

[0044] FIG. 5 is a flowchart illustrating a method 200 for localizing a medical tool. The method 200 is illustrated as a set of operations or processes that may be performed in the same or in a different order than the order shown. One or more of the illustrated processes may be omitted in some examples of the method. Additionally, one or more processes that are not expressly illustrated in FIG. 5 may be included before, after, in between, or as part of the illustrated processes. In some examples, one or more of the processes of method 200 may be implemented, at least in pail, by a control system executing code stored on non-transitory, tangible, machine- readable media that when run by one or more processors (e.g., the processors of a control system 612) may cause the one or more processors to perform one or more of the processes.

[0045] At process 202, a tool (e.g. the medical tool 166) may be localized relative to a signal transmitter supported by a device (e.g. the flexible elongate device 152) to which the tool is movably coupled. In some examples, a localization sensor (e.g. the localization sensor 167) near the tip of a medical tool may detect signals from the signal transmitter and use the detected signals to triangulate the location of the localization sensor, and thus the tip of the tool, relative to the signal transmitter. For example, the tool may include a localization sensor that includes an ultrasound transducer, and the signal transmitter may be an ultrasound transducer array positionedat a known location on a flexible elongate device. Ultrasound signals, in the form of acoustic waves, may be emitted from the ultrasound transducer array and received at the ultrasound transducer coupled to the tool. The ultrasound transducer may register receipt of the ultrasound signals. Information from the ultrasound transducer may be used to triangulate the location of the optical sensor (and / or a portion of the medical tool having a known configuration relative to the optical sensor) relative to the ultrasound transducer array.

[0046] FIG. 6 is a flowchart illustrating a method 250 for localizing a medical tool relative tool relative to a signal transmitter. The method 250 is an example of a technique that may be used to perform the process 202. In this example, the localization sensor may include an ultrasound transducer that is an optical sensor, and the signal transmitter may include an ultrasound transducer array. At a process 252, ultrasound signals may be emitted from one or more elements of ultrasound transducer array. Each of the elements of the transducer array may have a known position and orientation relative to the other elements of the transducer array. At a process 254, light may be sent to the optical fiber coupled to the medical tool. For example, a laser light source may be coupled to an optical fiber to send a light signal along the optical fiber to the optical sensor. In some examples, as described below, the optical sensor may include an optical interferometer, an optical resonator, or optical fiber-based sensors. At a process 256, the ultrasound signal is received at the optical sensor. For example, the optical sensor may be exposed within a window of the tool and acoustic signals may propagate through the window to be received by the optical sensor. At a process 258, modifications of light caused by ultrasound signals at the optical sensor are evaluated. For example, in the presence of the acoustic signals received at the optical sensor, the light sent to the optical sensor may undergo a wavelength or spectral shift. The optical sensor may send optical data indicating the detection of the acoustic signal to an optoelectronic device for processing. At a process 260, a distance between the optical sensor and activated elements of the transducer array may be determined. For example, based on the time of travel of the ultrasound signal and a known speed of the ultrasound signal, a plurality of distances between the optical sensor and the activated elements of the transducer array may be determined. At a process 262, the optical sensor may be localized relative to the transducer array. For example, the location of the optical sensor relative to the transducer array may be triangulated based on the determined plurality of distances and the known configuration of the transducer array.

[0047] With further reference to FIG. 5, at a process 204 the signal transmitter may be localized relative to a reference frame. For example, a signal transmitter may be localized relative to an image reference frame. In some examples, the image reference frame may be for an ultrasound image (2D or 3D) generated by an ultrasound signal transmitter. In some examples, the image reference frame may be an anatomical image (2D or 3D) for an anatomical model (e.g., a preoperative or intra-operative CT model). Localizing the signal transmitter to the image reference frame may include tracking a three-dimensional location of the signal transmitter using the imaging localization system 156. For example, the location of the signal transmitter may be fixed relative to a shape sensor of the imaging localization system that extends within the flexible elongate device 152. The frame of reference of the flexible elongate device 152 (and thus the frame of reference of the signal transmitters of the imaging device 161 that are part of the flexible elongate device), as measured by the imaging localization system 156 may be registered to the image reference frame. Registration of the image and device reference frames may include rotating, translating, or otherwise manipulating by rigid or non-rigid transforms points associated with one or both of the reference frames. In some examples, registration between image and device reference frames may be achieved, for example, by using a point-based iterative closest point (ICP) technique as described in U.S. Pat. App. Pub. Nos. 2018 / 0240237 and 2018 / 0235709, incorporated herein by reference in their entireties, or another point cloud registration technique.

[0048] At a process 206, the tool may be localized relative to the reference frame. More specifically, based on the localization of the tool to the signal transmitter and based on the localization of the signal transmitter to the reference frame, the location of the tool may be referenced to the reference frame. For example, with the location of the localization sensor 167 at a distal portion of the tool 166 known relative the ultrasound transducer of the imaging device 161, as described in process 202 and with the location of the ultrasound transducer known relative to an image reference frame as described in process 204, the location of the localization sensor 167 may be transformed into a location in the image reference frame. With the tool localized relative to an image reference frame, the locations of clinical actions, annotations, imaging, or other actions that occur in the tool reference frame may be registered to the image reference frame.

[0049] At a process 207, perform an operation using the localization of the tool relative to the reference frame. For example, at a process 208, an anatomical model in the reference frame may be marked at a location of an intervention with the tool. For example, a pre-operative anatomicalmodel may be annotated to indicate a location of a clinical intervention, the location of an anatomical condition, or another action or observation of the tool. In some examples, virtual markers may be added by a user to areas that have been biopsied or treated to enhance the user’s sense of location within the patient anatomy. Virtual markers, along with displayed model, may be virtually rotated to provide the user with an understanding of the location of the markers relative to the three-dimensional anatomy, a target tissue, or a lesion. In some examples, the model may be annotated with tissue boundary markers such as lymph node boundaries. In some examples, the model may be annotated with tool trajectories. In some examples, the process 208 may be omitted.

[0050] At a process 210, an integrated image of the tool with the anatomical model in the reference frame may be displayed. For example, a pre-operative anatomical 2D image or 3D model (e.g., a CT model) may be displayed, and an image or graphical representation of the tool may be overlayed or otherwise displayed in relation to the displayed model. In some examples, the process 210 may be omitted.

[0051] At a process 212, an integrated image of the tool with an image generated by the signal transmitter may be displayed. For example, an ultrasound image generated by data from the ultrasound transducer carried by the flexible elongate device 152 may be displayed, and an image or graphical representation of the tool 166 may be overlayed or otherwise displayed in relation to the displayed model. In some examples, the process 212 may be omitted.

[0052] A tool may be manufactured and configured to promote the performance of the tool for a medical procedure and to allow its location to be tracked using the localization sensor. In various examples, the tool may be used to perform a biopsy and may include a needle, forceps, brush, or other tissue sampling or collection device. In other examples, a tool may include an ablation tool including a heated or cryo-probe, an electroporation tool, a forceps, a medication delivery device, a fiducial delivery device, or another type of diagnostic or therapeutic device.

[0053] FIG. 7A illustrates a top view of a distal portion of a medical tool 300 (e.g. the medical tool 166) that may be extendable from, rotatable within, bendable relative to, or otherwise movable with respect to a flexible elongate device (e.g. flexible elongate device 152). The medical tool 300 may also be used with other types of medical instruments, including rigid elongate devices, robotic arms, etc. The medical tool 300 may include a tool body 302 and a localization sensor 304. The tool body 302 may be formed of a rigid material that may generally resist bending. In this example,the medical tool 300 may be a biopsy needle including a tapered or pointed, tissue penetrating tip 303.

[0054] In this example, the localization sensor 304 may be an optical sensor system including an optical fiber cable 308 and a sensor head 310 coupled to a distal end of the optical fiber cable 308. The optical fiber cable 308 may include, for example, one or more multi-mode optical fibers. In some examples the optical fiber cable 308 may have a relatively small diameter such as approximately 80 microns or smaller. The sensor head 310 may include, for example, one or more sensing elements such as a pressure sensor that may include an interferometer such as a Fabry- Perot interferometer. In some examples, the sensor head may include one or more optical resonators such as a whispering gallery mode resonator. In some examples, a sensor head may be a distal portion of the optical fiber cable 308 that may itself serve as the sensing element. The sensor head 310 may be located at a known distance DI from the tip 303 of the tool body 302. Thus, localizing the localization sensor may allow the location of the tip at the known distance DI to also be known. The optical sensor system may also include a light source 305, such as a laser light source, that may be coupled to or otherwise in optical communication with a proximal end portion of the optical fiber cable 308. The optical sensor system may also include an optoelectronic device 307, such as a photodetector, that converts light received from the optical fiber cable 308 into electrical signals. Light from the light source 305 may be carried to the sensor head 310, and light may be returned from the sensor head 310 to the optoelectronic device 307 for processing.

[0055] A window 306 may be formed at a distal end portion of the tool body 302, and the distal end of the optical fiber cable 308 and / or the sensor head 310 may be exposed within the window 306. The window 306 may be generally aligned with the tip 303 of the tool body 302. The window 306 may extend through a wall 309 of the tool body 302 and may be formed by electrical discharge machining (EDM), laser cutting, or other techniques. In this example, the window 306 may include a relatively straight distal edge 312 and distal comers 314. A passage 311 may be formed in the wall 309 to accommodate the optical fiber cable 308. In some examples, the passage 311 may be a groove formed, for example, by electrical discharge machining (EDM). In other examples, the passage 311 may be a slot through the wall 309 along all or a portion of its length. In various examples, the optical fiber cable 308 may be fully or partially surrounded within the passage 311 by an acoustic potting material 316. In various examples, acoustic potting material may extendwithin the window 306 to fill all or a portion of the window to eliminate air gaps that may form around the localization sensor 304 during use.

[0056] FIG. 7B illustrates a top view of a distal portion of a medical tool 320 (e.g. the medical tool 166) that may be extendable from, rotatable within, bendable relative to, or otherwise movable with respect to a flexible elongate device (e.g. flexible elongate device 152). The medical tool 320 may also be used with other types of medical instruments, including rigid elongate devices, robotic arms, etc. The medical tool 320 may be similar to the medical tool 300, with differences as described. In this example, a window 326 may be formed at a distal end portion of the tool body 302, and the distal end of the optical fiber cable 308 and / or the sensor head 310 may be exposed within the window 326. The window 326 may extend through a wall 309 of the tool body 302. In this example, the window 326 may include a curved distal portion 332. The curved distal portion 332 may allow acoustic signals from signal transmitters (e.g. signal transmitters 180, 181) to bounce off the curved surface and reflect back toward the center of the window 326 where the sensor head 310 is located. Thus, the curved distal portion 332 may strengthen the acoustic signals and improve detection which may improve triangulation of the location of the sensor head 310. A groove 331 may be formed, for example by EDM, in the wall 309 to accommodate the optical fiber cable 308. In this example, the groove 331 may extend distally of the window 326 to the tip 303. With the distal tip 303 generally axially aligned with the groove 331, the EDM may damage the distal tip 303 or the wall thickness at the distal tip 303 may be thinned, reducing the forces it may withstand. The optical fiber cable 308 may be fully or partially surrounded within the groove 331 by the acoustic potting material 316.

[0057] FIG. 7C illustrates a top view of a distal portion of a medical tool 340 (e.g. the medical tool 166) that may be extendable from, rotatable within, bendable relative to, or otherwise movable with respect to a flexible elongate device (e.g. flexible elongate device 152). The medical tool 340 may also be used with other types of medical instruments, including rigid elongate devices, robotic arms, etc. The medical tool 340 may be similar to the medical tool 300, with differences as described. In this example, a window 346 may be formed at a distal end portion of the tool body 302, and the distal end of the optical fiber cable 308 and / or the sensor head 310 may be exposed within the window 346. The window 346 may extend through a wall 309 of the tool body 302. In this example, the window 346 may include a curved distal portion 352. A slot 351 may be formed, for example by laser cutting, in the wall 309 to accommodate the optical fiber cable 308. In thisexample, the slot 351 may terminate at the window 346 and not extend distally to damage the sharpened tip 303. The optical fiber cable 308 may be fully or partially surrounded within the slot 351 by the acoustic potting material 316.

[0058] FIG. 7D illustrates a side view of a distal portion of a medical tool 360 (e.g. the medical tool 166) that may be extendable from, rotatable within, bendable relative to, or otherwise movable with respect to a flexible elongate device (e.g. flexible elongate device 152). The medical tool 360may also be used with other types of medical instruments, including rigid elongate devices, robotic arms, etc. The medical tool 360 may be similar to the medical tool 300, with differences as described. A window 366 may be formed at a distal end portion of the tool body 302, and the distal end of the optical fiber cable 308 and / or the sensor head 310 may be exposed within the window 366. In this example, the window 366 may be radially offset from alignment with the tip 303 of the tool 360. In some examples, as shown in FIG. 7D, the window 366 may be rotated approximately 90 degrees from alignment with the tip 303. A groove 371 may be formed, for example by EDM, in the wall 309 to accommodate the optical fiber cable 308. In this example, the groove 371 may also extend distally of the window 326, and the groove may also be offset from alignment with the tip 303. With groove 371 offset from the distal tip 303, the EDM used to form the groove may avoid damaging the distal tip 303. The optical fiber cable 308 may be fully or partially surrounded within the groove 371 by the acoustic potting material 316.

[0059] FIG. 8A and 8B illustrate opposite side views of a distal portion of a medical tool 380 (e.g. the medical tool 166) that may be extendable from, rotatable within, bendable relative to, or otherwise movable with respect to a flexible elongate device (e.g. flexible elongate device 152). The medical tool 380 may also be used with other types of medical instruments, including rigid elongate devices, robotic arms, etc. In this example, the medical tool 380 may include an asymmetrical tool body 382 having a body wall 389. The tool body 382 may be formed of a rigid material that may generally resist bending. In this example, the medical tool 380 may be a biopsy needle including a tapered or pointed tip 383 and including a bevel 384 surrounding an opening 385 to a channel 388 through the needle. The medical tool 380 may be similar- to the medical tool 300, with additional differences as described. A window 386 may be formed at a distal end portion of the tool body 382, and the distal end of the optical fiber cable 308 and / or the sensor head 310 may be exposed within the window 386. In this example, the window 386 may be offset from alignment with the tip 383 of the tool 380. In some examples, as shown in FIGS. 8A and 8B, thewindow 386 may be rotated approximately 90 degrees from alignment with the tip 383. The asymmetrical tool body 382 is configured such that a wall of the tool body 382 opposite the window 386 has a gradually tapered profile 387 so that the wall opposite the window 386 does not block acoustic signals from reaching the window. A groove 391 may be formed, for example by EDM, in the wall 389 to accommodate the optical fiber cable 308. In this example, the groove 391 may also extend distally of the window 386, and the groove may also be offset from alignment with the tip 383. With groove 391 offset from the distal tip 383, the EDM used to form the groove may avoid damaging the distal tip 383.

[0060] FIG. 9A illustrates a top view of a medical tool 400 (e.g. the medical tool 166) that may be extendable from, rotatable within, bendable relative to, or otherwise movable with respect to a flexible elongate device (e.g. flexible elongate device 152). The medical tool 400 may also be used with other types of medical instruments, including rigid elongate devices, robotic arms, etc. Cross sectional views of the medical tool 400 are illustrated at FIGS. 9B-9D. The medical tool 400 may include a tool body 402 and a localization sensor 404. The tool body 402 may be the same or substantially similar to any of the tool bodies disclosed herein. The localization sensor 404 may be the same or substantially similar’ to any of the localization sensors described herein. The medical tool 400 may also include a flexible portion 408 coupled to or integrally formed with a proximal end of the tool body 402 and a tool shaft 406 coupled to or integrally formed with a proximal end of the flexible portion. In some examples, the flexible portion 408 may include a hypotube with a plurality of laser cut slits. The tool shaft 406 may have an outer diameter D2 that is larger than an outer diameter D3 of the tool body. The tool shaft 406 may include a tapered portion 407 into which the proximal end of the flexible portion extends. The tool shaft 406 may include a shaft wall 409 surrounding an elongate passage 410. As shown in FIG. 9C, an optical fiber cable 412 of the localization sensor may extend untethered or floating within the passage 410. In some examples, the optical fiber cable 412 may extend within a floating fiber support channel 414 that may resist kinking of the optical fiber cable and / or damage from interaction with other tools passing within the passage 410. The optical fiber cable 412 may be fixed relative to the tool body 402 but may be allowed to piston longitudinally and / or rotate relative to the tool shaft 406 and flexible portion 408. A passage 422 within a wall 421 of the flexible portion 408 may carry the optical fiber cable 412 between the tool shaft 406 and the tool body 402. An inner support member 416 may extend within the flexible portion 408 to prevent migration of the optical fiber cable 412 into a centralpassage 420 of the flexible portion 408. The inner support member may also prevent the central passage 420 from collapsing and resist kinking of the flexible portion. In some examples, the inner support member 416 may include a laser cut hypotube that includes a plurality of slits or a single helical slit. In some examples, the hypotube may be attached to an inner surface 418 of the flexible portion 408 by spot welding or by tack laser welding. In some examples, the inner support member 416 may include a continuous tube formed of a flexible material such as nitinol. In some examples, the flexible inner support member 416 may include a combination of polymer and metal materials, such as a braided metal wire structure encased in a polymer tube. A continuous flexible tube or an encased metal braid may provide a seal, preventing ingress of fluid or debris. Additionally or alternatively, a flexible sleeve 423 may extend along the flexible portion 408 to prevent ingress of fluid or debris.

[0061] FIG. 10A illustrates a top view of a medical tool 500 (e.g. the medical tool 166) that may be extendable from, rotatable within, bendable relative to, or otherwise movable with respect to a flexible elongate device (e.g. flexible elongate device 152). The medical tool 500 may also be used with other types of medical instruments, including rigid elongate devices, robotic arms, etc. Cross sectional views of the medical tool 500 are illustrated at FIGS. 10B-10D. The medical tool 500 may include a tool body 502 and a localization sensor 504. The tool body 502 may be the same or substantially similar to any of the tool bodies disclosed herein. The localization sensor 504 may be the same or substantially similar to any of the localization sensors described herein. The medical tool 500 may also include a flexible portion 508 coupled to or integrally formed with a proximal end of the tool body 502 and a tool shaft 506 coupled to or integrally formed with a proximal end of the flexible portion. In some examples, the flexible portion 508 may include a hypotube with a plurality of laser cut slits. The tool shaft 506 may have an outer diameter D2 that is larger than an outer diameter D3 of the tool body. The tool shaft 506 may include a tapered portion 505 into which the proximal end of the flexible portion extends. The tool shaft 506 may include a shaft wall 509 surrounding an elongate passage 510. As shown in FIG. 10C, an optical fiber cable 512 of the localization sensor may extend within a lumen 507 through the shaft wall 509. In some examples the shaft wall 509 may protrude into the elongate passage to accommodate the lumen 507 and the optical fiber cable 512. In other examples, the optical fiber cable 512 may extend untethered to the shaft wall as previously described. The optical fiber cable 512 may be fixed relative to the tool body 502 but may be allowed to piston longitudinally and / or rotate relativeto the tool shaft 506 and flexible portion 508. A passage 522 within a wall 521 of the flexible portion 508 may carry the optical fiber cable 512 between the tool shaft 506 and the tool body 502. An inner support member 516 may extend within the flexible portion 508 to prevent migration of the optical fiber cable 512 into a central passage 520 of the flexible portion 508. The inner support member 516 may also prevent the central passage 520 from collapsing and resist kinking of the flexible portion. In some examples, the inner support member 516 may include a flexible polymer tube affixed to an inner surface 518 of the flexible portion 508 by an adhesive. In some examples, the flexible inner support member 516 may include a combination of polymer and metal materials, such as a braided metal wire structure encased in a polymer tube that is affixed by an adhesive. An encased metal braid may provide a seal, preventing ingress of fluid or debris. A flexible sleeve 523 may extend along the flexible portion 508 to prevent ingress of fluid or debris.

[0062] In some examples, procedures may be performed using hand-held or otherwise manually controlled flexible elongate devices and tools of this disclosure. In other examples, the described devices and tools many be manipulated with a medical system. FIG. 10 is a simplified diagram of a medical system 600 according to some embodiments. The medical system 600 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 robot-assisted medical systems.

[0063] As shown in FIG. 11, medical system 600 may include a manipulator assembly 602 that controls the operation of a medical instrument 604 (e.g., medical instrument system 100, 150) in performing various procedures on a patient P. Medical instrument 604 may extend into an internal site within the body of patient P via an opening in the body of patient P. The manipulator assembly 602 may be robot-assisted, non-assisted, or a hybrid robot-assisted and non-assisted assembly with select degrees of freedom of motion that may be motorized and / or robot-assisted and select degrees of freedom of motion that may be non-motorized and / or non-assisted. The manipulator assembly 602 may be mounted to and / or positioned near a patient table T. A master assembly 606 allows an operator O (e.g., a surgeon, a clinician, a physician, or other user) to control the manipulatorassembly 602. In some examples, the master assembly 606 allows the operator O to view the procedural site or other graphical or informational displays. In some examples, the manipulator assembly 602 may be excluded from the medical system 600 and the instrument 604 may be controlled directly by the operator O. In some examples, the manipulator assembly 602 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 604.

[0064] The master assembly 606 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 as at the side of the patient table T. In some examples, the master assembly 606 is remote from the patient table T, such as in in a different room or a different building from the patient table T. The master assembly 606 may include one or more control devices for controlling the manipulator assembly 602. 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.

[0065] The manipulator assembly 602 supports the medical instrument 604 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 612). The manipulator assembly 602 may include a plurality of actuators (e.g., motors) that drive inputs on the medical instrument 604 in response to commands, such as from the control system 612. The actuators may include drive systems that move the medical instrument 604 in various ways when coupled to the medical instrument 604. For example, one or more actuators may advance medical instrument 604 into a naturally or surgically created anatomic orifice. Actuators may control articulation of the medical instrument 604, such as by moving the distal end (or any other portion) of medical instrument 604 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 604, 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., imagingtools, ablation tools, biopsy tools, electroporation tools, etc.) that are inserted within the medical instrument 604.

[0066] The medical system 600 may include a sensor system 608 with one or more sub-systems for receiving information about the manipulator assembly 602 and / or the medical instrument 604. 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 604; a visualization system 709 (e.g., using a color imaging device, an infrared imaging device, an ultrasound imaging device, an x-ray imaging device, a fluoroscopic imaging device, a 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 604 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 604.

[0067] The medical system 600 may include a display system 610 for displaying an image or representation of the procedural site and the medical instrument 604. Display system 610 and master assembly 606 may be oriented so physician O can control medical instrument 604 and master assembly 606 with the perception of telepresence.

[0068] In some embodiments, the medical instrument 604 may include a visualization system 609, 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 610. 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 604. Additionally or alternatively, a separate endoscope, attached to a separate manipulator assembly, may be used with medical instrument 604 to image the procedural site. The visualization system may be implemented as hardware, firmware, software ora combination thereof which interact with or are otherwise executed by one or more computer processors, such as of the control system 612.

[0069] Display system 610 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 600 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 604 may be presented by the display system 610 to provide the perception of being at the distal portion of the medical instrument 604 to the operator O. The input to the master assembly 606 provided by the operator O may move the distal portion of the medical instrument 604 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 604. As such, the perception of telepresence for the operator O is maintained as the medical instrument 604 is moved using the master assembly 606. The operator O can manipulate the medical instrument 604 and hand controls of the master assembly 606 as if viewing the workspace in substantially true presence, simulating the experience of an operator that is physically manipulating the medical instrument 604 from within the patient anatomy.

[0070] In some examples, the display system 610 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 100, 150) or intra-operatively (e.g., concurrent with the procedure performed by the medical instrument system 100, 150), 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 higher-dimensional (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.

[0071] In some examples, for purposes of imaged guided medical procedures, display system 610 may display a virtual image that is generated based on tracking the location of medical instrument 604. For example, the tracked location of the medical instrument 604 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 correspond with different locations of the patient anatomy. As the medical instrument 604 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 604 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 604 that correspond with the tracked locations of the medical instrument 604.

[0072] The medical system 600 may also include the control system 612, which may include processing circuitry that implements the some or all of the methods or functionality discussed herein. The control system 612 may include at least one memory 616 and at least one processor 714 for controlling the operations of the manipulator assembly 602, the medical instrument 604, the master assembly 606, the sensor system 608, and / or the display system 610. Control system 612 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 612 is shown as a single block in FIG. 11, the control system 612 may include two or more separate data processing circuits with one portion of the processing being performed at the manipulator assembly 602, another portion of the processing being performed at the master assembly 606, and / or the like. In some examples, the control system 612 may include other types of processing circuitry, such as application- specific integrated circuits (ASICs) and / or field- programmable gate array (FPGAs). The control system 612 may be implemented using hardware, firmware, software, or a combination thereof.

[0073] In some examples, the control system 612 may receive feedback from the medical instrument 604, such as force and / or torque feedback. Responsive to the feedback, the control system 612 may transmit signals to the master assembly 606. In some examples, the control system 612 may transmit signals instructing one or more actuators of the manipulator assembly 602 to move the medical instrument 604. In some examples, the control system 612 may transmit informational displays regarding the feedback to the display system 610 for presentation or perform other types of actions based on the feedback.

[0074] The control system 612 may include a virtual visualization system to provide navigation assistance to operator O when controlling the medical instrument 604 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 612 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 608 that is used to compute an (e.g., approximate) location of the medical instrument 604 with respect to the anatomy of patient P. The sensor system 608 may be used to register and display the medical instrument 604 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.

[0075] During a virtual navigation procedure, the sensor system 608 may be used to compute the (e.g., approximate) location of the medical instrument 604 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 optic 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.

[0076] Medical system 600 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 600 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.

[0077] FIG. 12A is a simplified diagram of a medical instrument system 700 according to some embodiments. The medical instrument system 700 includes a flexible elongate device 702 (e.g. flexible elongate device 152), a drive unit 704, and a medical tool 826 that collectively is an example of a medical instrument 604 of a medical system 600. The medical system 600 may be a robot-assisted system, a non-robot-assisted system, or a hybrid robot-assisted and non-assisted system, as explained with reference to FIG. 11. A visualization system 731, tracking system 730, and navigation system 732 are also shown in FIG. 12A and are example components of the control system 612 of the medical system 600. In some examples, the medical instrument system 700 may be used for non-robot-assisted exploratory procedures or in procedures involving traditional manually operated medical instruments, such as endoscopy. The medical instrument system 700 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.

[0078] The elongate device 702 is coupled to the drive unit 704. The elongate device 702 includes a channel 721 through which the medical tool 726 may be inserted. The elongate device 702 navigates within patient anatomy to deliver the medical tool 726 to a procedural site. The elongate device 702 includes a flexible body 716 having a proximal end 717 and a distal end 718. In some examples, the flexible body 716 may have an approximately 3 mm outer diameter. Other flexible body outer diameters may be larger or smaller.

[0079] Medical instrument system 700 may include the tracking system 730 for determining the position, orientation, speed, velocity, pose, and / or shape of the flexible body 716 at the distal end 718 and / or of one or more segments 724 along flexible body 716, as will be described in further detail below. The tracking system 730 may include one or more sensors and / or imaging devices. The flexible body 716, such as the length between the distal end 718 and the proximal end 717, may include multiple segments 724. The tracking system 730 may be implemented using hardware, firmware, software, or a combination thereof. In some examples, the tracking system 730 is part of control system 612 shown in FIG. 1.

[0080] Tracking system 730 may track the distal end 718 and / or one or more of the segmentsfiber aligned with the flexible body 716 (e.g., provided within an interior channel of the flexibly body 716 or mounted externally along the flexible body 716). 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 722 may form a fiber optic bend sensor for determining the shape of flexible body 716. 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.

[0081] In some examples, the shape of the flexible body 716 may be determined using other techniques. For example, a history of the position and / or pose of the distal end 718 of the flexible body 716 can be used to reconstruct the shape of flexible body 716 over an interval of time (e.g., as the flexible body 716 is advanced or retracted within a patient anatomy). In some examples, the tracking system 730 may alternatively and / or additionally track the distal end 718 of the flexible body 716 using a position sensor system 720. Position sensor system 720 may be a component of an EM sensor system with the position sensor system 720 including one or more position sensors. Although the position sensor system 720 is shown as being near the distal end 718 of the flexible body 716 to track the distal end 718, the number and location of the position sensors of the position sensor system 720 may vary to track different regions along the flexible body 716. 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 720 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 720 may measure one or more position coordinates and / or one or more orientation angles associated with one or more portions of flexible body 716. In some examples, the position sensor system 720 may be configuredand 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 720 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.

[0082] In some embodiments, the tracking system 730 may alternately and / or additionally rely on a collection of pose, position, and / or orientation data stored for a point of an elongate device 702 and / or medical tool 726 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 716. In some examples, a series of position sensors (not shown), such as EM sensors like the sensors in position sensor 720 or some other type of position sensors may be positioned along the flexible body 716 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 702, particularly if an anatomic passageway is generally static.

[0083] FIG. 12B is a simplified diagram of the medical tool 726 within the elongate device 702 according to some embodiments. The flexible body 716 of the elongate device 702 may include the channel 721 sized and shaped to receive the medical tool 726. In some embodiments, the medical tool 726 may be used for procedures such as diagnostics, imaging, surgery, biopsy, ablation, illumination, irrigation, suction, electroporation, etc. Medical tool 726 can be deployed through channel 721 of flexible body 716 and operated at a procedural site within the anatomy. Medical tool 726 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 therapeutic tool. In some examples, the medical tool 726 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 effectorsmay further include electrically activated end effectors such as electrosurgical electrodes, transducers, sensors, and / or the like.

[0084] The medical tool 726 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 721 when the biopsy tool is within the channel 721. The medical tool 726 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 718 of flexible body 716 for capturing images (e.g., still or video images). The captured images may be processed by the visualization system 731 for display and / or provided to the tracking system 730 to support tracking of the distal end 718 of the flexible body 716 and / or one or more of the segments 724 of the flexible body 716. 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 731. 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.

[0085] In some examples, the image capture probe is inserted within the flexible body 716 of the elongate device 702 to facilitate visual navigation of the elongate device 702 to a procedural site and then is replaced within the flexible body 716 with another type of medical tool 726 that performs the procedure. In some examples, the image capture probe may be within the flexible body 716 of the elongate device 702 along with another type of medical tool 726 to facilitate simultaneous image capture and tissue intervention, such as within the same channel 721 or in separate channels. A medical tool 726 may be advanced from the opening of the channel 721 to perform the procedure (or some other functionality) and then retracted back into the channel 721 when the procedure is complete. The medical tool 726 may be removed from the proximal end 717 of the flexible body 716 or from another optional instrument port (not shown) along flexible body 716.

[0086] In some examples, the elongate device 702 may include integrated imaging capability rather than utilize a removable image capture probe. For example, the imaging device (or fiberoptic bundle) and the light emitters may be located at the distal end 718 of the elongate device 702. The flexible body 715 may include one or more dedicated channels that carry the cable(s) and / or optical fiber(s) between the distal end 718 and the visualization system 731. Here, the medical instrument system 700 can perform simultaneous imaging and tool operations.

[0087] In some examples, the medical tool 726 is capable of controllable articulation. The medical tool 726 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 726, such as discussed herein for the flexible elongate device 702. The medical tool 726 may be coupled to a drive unit 704 and the manipulator assembly 602. In these examples, the elongate device 702 may be excluded from the medical instrument system 700 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.

[0088] The flexible body 716 of the elongate device 702 may also or alternatively house cables, linkages, or other steering controls (not shown) that extend between the drive unit 704 and the distal end 718 to controllably bend the distal end 718 as shown, for example, by broken dashed line depictions 719 of the distal end 718 in FIG. 12A. In some examples, at least four cables are used to provide independent up-down steering to control a pitch of the distal end 718 and left-right steering to control a yaw of the distal end 718. In these examples, the flexible elongate device 702 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.

[0089] In embodiments where the elongate device 702 and / or medical tool 726 are actuated by a robot-assisted assembly (e.g., the manipulator assembly 602), the drive unit 704 may includedrive inputs that removably couple to and receive power from drive elements, such as actuators, of the robot-assisted assembly. In some examples, the elongate device 702 and / or medical tool 726 may include gripping features, manual actuators, or other components for manually controlling the motion of the elongate device 702 and / or medical tool 726. The elongate device 702 may be steerable or, alternatively, the elongate device 702 may be non-steerable with no integrated mechanism for operator control of the bending of distal end 718. In some examples, one or more channels 721 (which may also be referred to as lumens), through which medical tools 726 can be deployed and used at a target anatomical location, may be defined by the interior walls of the flexible body 716 of the elongate device 702.

[0090] In some examples, the medical instrument system 700 (e.g., the elongate device 702 or medical tool 726) 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 700 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.

[0091] The information from the tracking system 730 may be sent to the navigation system 732, where the information may be combined with information from the visualization system 731 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 610 for use in the control of the medical instrument system 700. In some examples, the navigation system 732 may utilize the position information as feedback for positioning medical instrument system 700. 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.

[0092] In the description, specific details have been set forth describing some examples. Numerous specific details are set forth in order to provide a thorough understanding of the examples. It will be apparent, however, to one skilled in the art that some examples may bepracticed without some or all of these specific details. The specific examples 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.

[0093] Elements described in detail with reference to one example, implementation, or application optionally may be included, whenever practical, in other examples, implementations, or applications in which they are not specifically shown or described. For example, if an element is described in detail with reference to one example and is not described with reference to a second example, the element may nevertheless be claimed as included in the second example. Thus, to avoid unnecessary repetition in the following description, one or more elements shown and described in association with one example, implementation, or application may be incorporated into other examples, implementations, or aspects unless specifically described otherwise, unless the one or more elements would make an example or implementation non-functional, or unless two or more of the elements provide conflicting functions.

[0094] Any alterations and further modifications to the described devices, instruments, methods, and any further application of the principles of the present disclosure are fully contemplated as would normally occur to one skilled in the art to which the disclosure relates. In particular, it is fully contemplated that the features, components, and / or steps described with respect to one example may be combined with the features, components, and / or steps described with respect to other examples of the present disclosure. In addition, dimensions provided herein are for specific examples and it is contemplated that different sizes, dimensions, and / or ratios may be utilized to implement the concepts of the present disclosure. To avoid needless descriptive repetition, one or more components or actions described in accordance with one illustrative example can be used or omitted as applicable from other illustrative examples. For the sake of brevity, the numerous iterations of these combinations will not be described separately. For simplicity, in some instances the same reference numbers are used throughout the drawings to refer to the same or like parts.

[0095] The systems and methods described herein may be suited for imaging, via natural or surgically created connected passageways, in any of a variety of anatomic systems, including the lung, colon, the intestines, the stomach, the liver, the kidneys and kidney calices, the brain, the heart, the circulatory system including vasculature, and / or the like. While some examples are provided herein with respect to medical procedures, any reference to medical or surgicalinstruments and medical or surgical methods is non-limiting. For example, the instruments, systems, and methods described herein may be used for non-medieal purposes including industrial uses, general robotic uses, and sensing or manipulating non-tissue work pieces. Other example applications involve cosmetic improvements, imaging of human or animal anatomy, gathering data from human or animal anatomy, and training medical or non-medical personnel. Additional example applications include use for procedures on tissue removed from human or animal anatomies (without return to a human or animal anatomy) and performing procedures on human or animal cadavers. Further, these techniques can also be used for surgical and nonsurgical medical treatment or diagnosis procedures.

[0096] The methods described herein are illustrated as a set of operations or processes. Not all the illustrated processes may be performed in all examples of the methods. Additionally, one or more processes that are not expressly illustrated or described may be included before, after, in between, or as pail of the example processes. In some examples, one or more of the processes may be performed by the control system (e.g., control system 612) or may be implemented, at least in part, in the form of executable code stored on non-transitory, tangible, machine-readable media that when ran by one or more processors (e.g., the processors 614 of control system 612) may cause the one or more processors to perform one or more of the processes.

[0097] One or more components of the embodiments discussed in this disclosure, such as control system 612, 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 pail 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 the 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 thesystems 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).

[0098] Note that the processes and displays presented may not inherently be related to any particular computer or other apparatus. Various general-purpose systems may be used with programs in accordance with the teachings herein, or it may prove convenient to construct a more specialized apparatus to perform the operations described. The required structure for a variety of these systems will appear as elements in the claims. In addition, the examples of the invention are not described with reference to any particular programming language. It will be appreciated that a variety of programming languages may be used to implement the teachings of the invention as described herein.

[0099] In some instances well known methods, procedures, components, and circuits have not been described in detail so as not to unnecessarily obscure aspects of the examples. This disclosure describes various instruments, portions of instruments, and anatomic structures 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 (three degrees of rotational freedom - e.g., 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 (up to six total degrees of freedom). As used herein, the term “shape” refers to a set of poses, positions, 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.

[0100] While certain exemplary examples of the invention have been described and shown in the accompanying drawings, it is to be understood that such examples arc merely illustrative of and not restrictive on the broad invention, and that the examples of the invention not be 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

CLAIMSWhat is claimed is:

1. A system comprising: a flexible elongate device including one or more signal transmitters; a tool configured to extend from a distal end of the flexible elongate device, the tool comprising: a body portion defining a window; and a localization sensor coupled to the body portion, at least a portion of the localization sensor being exposed by the window to receive a signal from the one or more signal transmitters through the window; and a control system configured to determine a location of the tool based on the signal received by the localization sensor from the one or more signal transmitters.

2. The system of claim 1, wherein the one or more signal transmitters include an ultrasound transducer, the localization sensor includes an optical fiber, and the signal includes an acoustic signal.

3. The system of claim 1, wherein the body portion absorbs the signal from the one or more signal transmitters.

4. The system of claim 1, wherein the one or more signal transmitters are disposed at a distal portion of the flexible elongate device.

5. The system of claim 1, wherein the one or more signal transmitters include a forwardfacing linear transducer array.

6. The system of claim 1, wherein the one or more signal transmitters include a forwardfacing annular transducer array.

7. The system of claim 1 , wherein the one or more signal transmitters include a side-facing transducer array.

8. The system of claim 1, wherein the localization sensor includes an optical fiber.

9. The system of claim 1, wherein the localization sensor includes an ultrasound receiver.

10. The system of claim 1, wherein the tool includes a biopsy needle.

11. The system of claim 1, wherein the tool includes an imaging device.

12. The system of claim 1, wherein the tool includes an ablation device.

13. The system of claim 1, wherein the tool includes an electroporation device.

14. The system of claim 1, wherein the control system is configured to determine the location of the tool relative to the one or more signal transmitters.

15. The system of claim 1, wherein the control system is configured to register the flexible elongate device to a reference frame and determine a location of the tool relative to the reference frame based on the location of the tool relative to the one or more signal transmitters.

16. The system of claim 1, wherein the tool includes a proximal flexible section and a distal rigid section.

17. The system of claim 16, wherein the proximal flexible section includes a plurality of slits.

18. The system of claim 16, further comprising a flexible sleeve extending around the proximal flexible section.

19. The system of claim 16, wherein the window is in the distal rigid section.

20. The system of claim 1 , wherein the window includes a curved distal edge.

21. The system of claim 1, wherein the window is formed by electrical discharge machining or laser cutting.

22. The system of claim 1, wherein an optical fiber passage extends within a groove in a wall of the tool proximally of the window.

23. The system of claim 22, wherein the groove in the wall of the tool is formed by electrical discharge machining or laser cutting.

24. The system of claim 1, wherein the window is aligned with a distal tip of the body portion.

25. The system of claim 1, wherein the window is radially offset from a distal tip of the body portion.

26. The system of claim 1, further comprising an acoustic potting adhered to a distal portion of the localization sensor within the window.

27. The system of claim 1, wherein the tool includes an inner support member defining a central passage.

28. The system of claim 27, wherein the inner support member includes a polymer tube or a metal tube.

29. The system of claim 27, wherein the inner support member includes a laser cut hypotube.

30. The system of claim 1, wherein the tool includes a tool shaft coupled to the body portion.31 . The system of claim 30, wherein a wall of the tool shaft includes a sensor lumen sized to receive the localization sensor.

32. The system of claim 30, wherein a wall of the tool shaft surrounds a tool shaft passage, and the localization sensor extends within the tool shaft passage.

33. The system of claim 1, wherein the one or more signal transmitters includes a plurality of spaced apart signal transmitters, and the control system is configured to determine the location of the tool by triangulating signals propagated by the plurality of spaced apart signal transmitters.

34. The system of claim 1, further comprising an auxiliary signal transmitter, wherein the auxiliary signal transmitter is separate from the flexible elongate device and wherein the control system is configured to determine the location of the tool based on signals received by the localization sensor from the auxiliary signal transmitter and the one or more signal transmitters of the flexible elongate device.

35. The system of claim 1, further comprising a laser to transmit light to the localization sensor.

36. The system of claim 1, further comprising a photodetector to detect received light having a wavelength shifted by the signal from the one or more signal transmitters.

37. The system of claim 1, wherein the tool includes a tool member and an elongated implement sized to extend within the tool member and wherein the elongated implement includes the body portion defining the window.

38. A medical tool comprising: a body portion with an acoustic window defined in the body portion; and an optical fiber localization sensor extending into the acoustic window,wherein the acoustic window is configured to allow through passage of an ultrasound signal and wherein the body portion around the acoustic window is configured to absorb the ultrasound signal.

39. The medical tool of claim 38, wherein the medical tool further comprises a tissue penetrating tip configured to biopsy tissue.

40. The medical tool of claim 38, wherein the medical tool further comprises an imaging device.

41. The medical tool of claim 38, wherein the medical tool further comprises an ablation device.

42. The medical tool of claim 38, wherein the medical tool further comprises an electroporation device.

43. The medical tool of claim 38, wherein the medical tool includes a proximal flexible section and a distal rigid section.

44. The medical tool of claim 43, wherein the proximal flexible section includes a plurality of slits.

45. The medical tool of claim 43, further comprising a flexible sleeve extending around the proximal flexible section.

46. The medical tool of claim 43, wherein the acoustic window is in the distal rigid section.

47. The medical tool of claim 38, wherein the acoustic window includes a curved distal edge.

48. The medical tool of claim 38, wherein an optical fiber passage extends within a wall of the body portion proximally of the acoustic window.

49. The medical tool of claim 38, wherein the acoustic window is aligned with a distal tip of the body portion.

50. The medical tool of claim 38, wherein the acoustic window is radially offset from a distal tip of the body portion.

51. The medical tool of claim 38, further comprising an acoustic potting adhered to a distal portion of the optical fiber localization sensor within the acoustic window.

52. The medical tool of claim 38, further comprising an inner support member defining a central passage.

53. The medical tool of claim 52, wherein the inner support member includes a polymer tube or a metal tube.

54. The medical tool of claim 52, wherein the inner support member includes a laser cut hypotube.

55. The medical tool of claim 38, further comprising a tool shaft coupled to the body portion.

56. The medical tool of claim 55, wherein a wall of the tool shaft includes a sensor lumen sized to receive the optical fiber localization sensor.

57. The medical tool of claim 55, wherein a wall of the tool shaft surrounds a tool shaft passage, and the localization sensor extends within the tool shaft passage.

58. The medical tool of claim 38, further comprising a tool member and an elongated implement sized to extend within the tool member and wherein the elongated implement includes the body portion defining the window.

59. A method comprising: localizing a tool relative to one or more ultrasound transducers supported by an instrument to which the tool is movably coupled; localizing the one or more ultrasound transducers relative to a reference frame; and based on the localization of the tool to the one or more ultrasound transducers, localizing the tool relative to the reference frame.

60. The method of claim 59, wherein the reference frame is defined with respect to a model of an anatomical region.

61. The method of claim 60, further comprising marking the model of the anatomical region at a location of an intervention with the tool.

62. The method of claim 60, further comprising displaying an integrated image of the tool with the model of the anatomic region.

63. The method of claim 59, wherein localizing the tool includes localizing a distal end of the tool.

64. The method of claim 59, further comprising displaying an integrated image of the tool with an image generated by an ultrasound imaging system including the one or more ultrasound transducers.

65. The method of claim 59, wherein localizing the tool includes emitting an ultrasound signal from the one or more ultrasound transducers and triangulating a location of the tool relative to the one or more ultrasound transducers.

66. The method of claim 65, wherein the ultrasound signal passes through a window in the tool, wherein the window surrounds at least a portion of a localization sensor.

67. The method of claim 59, wherein localizing the tool is relative to an ultrasound transducer separate from the instrument.

Images