Medical tool with signal window and method of use

Abstract

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

Description

[0001] Cross-reference to related applications

[0002] This application claims priority and benefit to U.S. Provisional Application No. 63 / 584,399, filed September 21, 2023, entitled “Medical Tool with Signal Window and Methods of Use,” which is incorporated herein by reference in its entirety. Technical Field

[0003] This disclosure relates to systems and methods for locating medical tools, including signal windows. Background Technology

[0004] Minimally invasive medical techniques aim to reduce the amount of tissue damaged during medical procedures, thereby reducing patient recovery time, discomfort, and harmful side effects. Such techniques can be performed through natural openings in the patient's anatomy or through one or more surgical incisions. Through these natural openings or incisions, the operator can insert minimally invasive medical instruments (including surgical, diagnostic, therapeutic, and / or biopsy instruments) to reach target tissue locations. One such technique utilizes flexible elongating devices (e.g., flexible catheters, bronchoscopes, or endoscopes) that can be inserted into an anatomical channel and navigated toward a region of interest within the patient's anatomy. Various medical instruments can extend from the flexible elongating device. Improved systems and methods are needed to position medical instruments relative to the anatomical region in which they extend and the flexible elongating device. Summary of the Invention

[0005] The following is a simplified overview of the various examples described herein and is not intended to identify key or important elements or to depict the scope of the claims.

[0006] In some examples, a system may include: a flexible elongation device including one or more signal transmitters; and a tool configured to extend from a distal end of the flexible elongation device. The tool may include: a body portion defining a window; and a positioning sensor coupled to the body portion. At least a portion of the positioning sensor is exposed through the window to receive signals from one or more signal transmitters. The system may also include: a control system configured to determine the position of the tool based on signals received by the positioning sensor from one or more signal transmitters.

[0007] In some examples, a medical tool may include: a body portion defining an acoustic window; and a fiber optic positioning sensor extending into the acoustic window. The acoustic window is configured to allow ultrasound signals to pass through, and wherein the body portion surrounding the acoustic window is configured to absorb the ultrasound signals.

[0008] In some examples, a method may include: positioning the tool relative to one or more ultrasonic transducers supported by an instrument, the tool being movably coupled to the instrument; and positioning one or more ultrasonic transducers relative to a reference frame. Based on the positioning of the tool relative to one or more ultrasonic transducers, the tool can be positioned relative to a reference frame.

[0009] It should 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 this disclosure, without limiting its scope. In this regard, additional aspects, features, and advantages of this disclosure will be apparent to those skilled in the art from the following detailed description. Attached Figure Description

[0010] Figure 1 Examples of flexible elongation devices in patient anatomy near target tissues are shown, based on some examples.

[0011] Figure 2 A flexible elongation device extending within an anatomical pathway is shown according to some examples.

[0012] Figure 3A An end view of a flexible elongation device according to some examples is shown.

[0013] Figure 3B An end view of a flexible elongation device according to some examples is shown.

[0014] Figure 3C A side view of a flexible elongation device based on some examples is shown.

[0015] Figure 4A The image shows a top view of a medical tool, including windows, based on some examples.

[0016] Figure 4B The image shows a side view of a medical tool including an elongated implement, based on some examples.

[0017] Figure 5 This is a flowchart illustrating methods for locating medical tools, based on some examples.

[0018] Figure 6This is a flowchart illustrating, according to some examples, a method for locating a medical tool relative to a signal transmitter.

[0019] Figure 7A The image shows a top view of a medical tool, including windows, based on some examples.

[0020] Figure 7B The image shows a top view of a medical tool, including windows, based on some examples.

[0021] Figure 7C The image shows a top view of a medical tool, including windows, based on some examples.

[0022] Figure 7D The image shows a side view of a medical tool, including a window, based on some examples.

[0023] Figure 8A The image shows a side view of a medical tool, including a window, based on some examples.

[0024] Figure 8B It shows Figure 8A A relative side view of the medical instruments.

[0025] Figure 9A A top view of medical tools, based on some examples, is shown.

[0026] Figure 9B , Figure 9C and Figure 9D It shows Figure 9A A cross-sectional view of a medical tool.

[0027] Figure 10A A top view of medical tools, based on some examples, is shown.

[0028] Figure 10B , Figure 10C and Figure 10D It shows Figure 10A A cross-sectional view of a medical tool.

[0029] Figure 11 It is a simplified diagram based on some examples of medical systems.

[0030] Figure 12A These are simplified diagrams of medical device systems based on some examples.

[0031] Figure 12B This is a simplified diagram of a medical device, including a medical tool within a flexible elongation device, based on some examples.

[0032] The embodiments and advantages of this disclosure will be better understood by referring to the following detailed description. It should be understood that the same reference numerals are used to identify one or more of the same elements shown in the drawings, which are illustrated for the purpose of explaining embodiments of this disclosure and not for limiting the scope of embodiments of this disclosure. Detailed Implementation

[0033] The techniques discussed in this paper can be used to enhance the localization of medical tools, including biopsy tools or other types of tools, and their use in medical procedures. In some examples, the position of a medical tool can be tracked and localized relative to a signal transmitter, which can also be used for other sensing or imaging modalities. The signal transmitter can be registered to a reference frame (e.g., an anatomical reference frame), and thus the medical tool can be localized relative to the reference frame by virtue of its localization relative to the signal transmitter. Although some of the signal transmitters described herein are ultrasound signal transmitters that can also be used for image generation, it is anticipated that the systems and methods described herein can be applied using other types of signal transmitters.

[0034] Figure 1 A medical device system 100 extending within a branching anatomical passage or airway 102 of an anatomical structure 104 is illustrated. In some examples, the anatomical structure 104 may be a lung, and the passage 102 may include a trachea 106, a main bronchus 108, secondary bronchi 110, and tertiary bronchi 112. The anatomical structure 104 has an anatomical reference frame (X). A Y A Z A The distal portion 118 of the medical device system 100 can be advanced into an anatomical opening (e.g., a patient's mouth) and through an anatomical passage 102 to perform medical procedures, such as biopsy, ablation, electroporation, or other types of diagnostic or therapeutic procedures, at or near the target tissue 113.

[0035] like Figure 2 As shown, the medical device system 150 (e.g., the elongating medical device system 100) may include a flexible elongation device 152 that can extend through the anatomical passage 102. In some examples, the flexible elongation device 152 may be a robotic control system and / or a manual control system that controls the engagement and insertion / retraction of the flexible elongation device 152, or may be integrated into such a robotic control system and / or manual control system. The following... Figure 12A and Figure 12BExamples of medical device systems capable of bending and steering maneuvers in multiple degrees of freedom are described (e.g., system 700). The flexible elongation device 152 may include a visualization system 154 and an imaging positioning system 156. In some examples, the visualization system 154 may include an optical imaging system 158 (e.g., visible light) positioned at a distal portion of the flexible elongation device 152. In some examples, the visualization system 154 may also, or alternatively, include an imaging device 161 (also referred to as a “signal-based imaging device”) that generates images based on emitted signals and received signals reflected from the environment, such as an ultrasound or photoacoustic imaging device. The imaging device 161 may be located at a distal portion 163 of the flexible elongation device 152 or at one or more other locations on the flexible elongation device 152. The imaging device 161 may generate image data in a field of view 159. The optical imaging system 158 may generate image data in different fields of view. The ultrasound imaging device may include a transducer array, which may include multiple transducers of any size or shape, as described in more detail below. For ultrasound imaging, contact between the flexible elongation device 152 and the wall 157 of the anatomical channel 102 may be necessary or can improve the quality of the imaging data. For example, if the imaging device 161 includes an ultrasound transducer, the contact between the flexible elongation device 152 and the wall 157 can eliminate air gaps and facilitate efficient transmission of ultrasound signals and generation of clear images.

[0036] In some examples, the imaging positioning system 156 may include, for example, an optical fiber shape sensor, an electromagnetic (EM) sensor, or multiple EM sensors, positioned at a known location relative to the visualization system 154 to track the position and orientation of all or part of the visualization system 154. The imaging positioning system 156 can be used to track the configuration, including position and / or orientation, of the distal portion 163 (including the imaging device 161) of the flexible elongation device 152 in multiple (e.g., six) degrees of freedom. If the imaging device 161 or a component of the imaging device 161 is located at other portions of the flexible elongation device 152, the imaging positioning system 156 can be used to track the configuration of those other portions. Therefore, positioning data from the imaging positioning system 156 can be used to determine the configuration of 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 elongation device 152. The optical fiber, or a portion thereof, may be fixed at the distal portion 163 of the flexible elongation device 152 or at a known location relative to the imaging device 161 to provide positioning data, including position and / or orientation data, for the imaging device 161. With the distal end of the fiber optic shape sensor fixed at a constant offset relative to the imaging device 161, the position and orientation of the imaging device 161 can be determined by measuring the shape of the sensor. The proximal end of the shape sensor may be fixed or known relative to the robot-assisted medical system. In other examples, if the flexible elongation device is manually manipulated, the proximal end of the shape sensor may be fixed to the patient's body or another fixed or tracking location near the patient.

[0037] Shape sensors, such as fiber optic bend sensors, can include fiber Bragg gratings (FBGs) that can be used to provide strain measurements of a structure 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 July 16, 2004, disclosing "Fiber-optic shape and relative position sensing"), and U.S. Patent No. 6,389,187 (filed June 17, 1998, disclosing "Optical Fiber Bend Sensor"), all of which are incorporated herein by reference in their entirety. In some embodiments, the sensor may employ other suitable strain sensing techniques, such as Rayleigh scattering, Raman scattering, Brillouin scattering, and fluorescence scattering. In some examples, other techniques may be used to determine the shape of the flexible elongation device 152. For example, the shape of the flexible elongation device 152 can be reconstructed at time intervals using the history of the distal pose of the flexible elongation device 152. In some embodiments, the shape sensor may include multiple position sensors (e.g., electromagnetic position sensors) that collectively provide shape data regarding the shape of at least a portion of the flexible elongation device 152. Typically, a shape sensor, as used herein, can provide any number of data points along the length of the flexible elongation device 152 at a series of points monitored by the shape sensor, comprising any number of degrees of freedom, including three or six.

[0038] In some examples, the flexible elongation device 152 may include a steering maneuvering system 160, which includes control lines, cables, or other control devices for bending or steering maneuvers of the distal portion of the flexible elongation device 152, which may include a visualization system 154. In some examples, the flexible elongation device 152 may also include a passage or pathway 164 through which a tool 166 may extend to expose a port 155 of the flexible elongation device 152 for engaging target tissue 113. Port 155 is located at... Figure 2The tool 155 is shown as a distal port defined at the distal end of the flexible elongation device 152. In other examples, the port 155 may be located at other locations. For example, the port 155 may be a side port defined on a sidewall near the distal end of the flexible elongation device 152. The tool 166 can be advanced, retracted, rotated, or otherwise moved relative to the flexible elongation device 152 by manual or robotic control. The tool 166 may include a positioning sensor 167 for facilitating the determination of the position of the tool 166. The tool 166 may be, for example, a biopsy or tissue sampling tool, an ablation tool including a heating probe or a freezing probe, an electroporation tool, forceps, a drug delivery device, a reference delivery device, or another type of diagnostic or therapeutic device. In some examples, the tool 166 may have a flexible axis. The tool may include control lines or other control devices to bend or steer the tool in the direction of manipulation, for example, at an engageable portion of the tool at the distal end of the flexible axis.

[0039] Figure 3A An end view of a flexible elongation device 152A is shown. This flexible elongation device 152A may be identical or substantially similar to flexible elongation device 152, but with the differences described. In this example, imaging device 161 includes one or more signal transmitters 180. A signal transmitter 180 may be part of a transceiver that transmits and receives signals, or it may be a transmitter that transmits but does not receive signals. A signal transmitter 180 may include, for example, a linear array of forward-facing ultrasound transducer elements. In some examples, a signal transmitter 180 may include a main linear array 183 of transducer elements and at least one auxiliary transducer element 185 spaced apart from the main linear array. Although the linear array can track the position of the positioning sensor 167 in a single plane, the addition of spaced-apart auxiliary transducer elements can provide three-dimensional position information via triangulation of the positioning sensor 167. In some examples, the auxiliary transducers may be spaced apart and located on the flexible elongation device 152, and in some examples, the auxiliary transducers may be spaced apart on other devices, which may be located inside or outside the patient's anatomy. Other devices may be various flexible elongation devices (e.g., catheters, endoscopes, bronchoscopes, etc.), medical instruments, ultrasound devices, imaging devices (e.g., endoscopes, fluorescence imaging devices, cone-beam computed tomography (CBCT) devices, tomography devices, etc.), robotic arms, or some other type of device with auxiliary transducer elements.

[0040] Figure 3BAn end view of the flexible elongation device 152B is shown. The flexible elongation device 152B may be the same as or substantially similar to the flexible elongation device 152, but with the differences described. In this example, the imaging device 161 includes one or more signal transmitters 182. The signal transmitter 182 may consist only of transmitters, or it may be a transceiver component. The signal transmitter 182 may include, for example, a ring array of forward-facing ultrasonic transducer elements. The ring array can provide tracking of the positioning sensor 167 in three dimensions via triangulation of the positioning sensor 167.

[0041] Figure 3C A side view of a flexible elongation device 152C is shown. This flexible elongation device 152C may be the same as or substantially similar to the flexible elongation device 152, but with the differences described. In this example, the imaging device 161 includes one or more signal transmitters 187. A signal transmitter 187 may consist only of a transmitter, or it may be a component of a transceiver. A signal transmitter 187 may include, for example, a single or multiple side-facing ultrasonic transducer elements. The side-facing transducer elements can provide tracking of the positioning sensor 167 in three dimensions via triangulation of the positioning sensor 167.

[0042] More typically, three or more signal transmitters may be spaced apart at different locations near tool 166 to transmit signals to positioning sensor 167 located on tool 166, thereby determining the three-dimensional position of tool 166 relative to the signal transmitters. In various examples, the signal transmitters (e.g., signal transmitters 180 / 182 / 187) may be used to generate images as well as perform tool positioning. For example, in the case of tool positioning, the signal transmitters may be used to generate images in a plane based on the tool position.

[0043] Figure 4AA top view of a portion of the distal portion of a medical tool 190 (e.g., medical tool 166) is shown. The medical tool 190 may be able to extend from, rotate within, bend relative to, or otherwise move relative to a flexible elongation device (e.g., flexible elongation device 152). The medical tool 190 may also be used with other types of medical devices, including rigid elongation devices, robotic arms, etc. The medical tool 190 may include a tool body 192 (also referred to as the tool body portion) in which a positioning sensor 194 (e.g., positioning sensor 167) extends. In some examples, the positioning sensor 194 may include an optical fiber carrying signals (e.g., acoustic signals) received from a transmitter between the proximal and distal portions of the medical tool 190. A window 196 may be formed at the distal portion of the tool body 192. The window 196 may be an acoustic window for transmitting signals (e.g., acoustic signals from an ultrasound transmitter), while the surrounding tool body 192 may at least partially or completely absorb signals such as acoustic signals. In some examples, window 196 may be a hole through the wall of tool body 192. In other examples, window 196 may be a region within the wall of tool body 192 formed or filled with a material different from the material forming the wall, such as a material that is more capable of transmitting signals without attenuation or absorption compared to the wall material. In some examples, a thermoplastic such as polyether block amide may be used to fill the window. For example, a positioning sensor 194 at a distal end may be exposed by window 196 to receive signals generated from multiple directions by a signal transmitter (e.g., a signal transmitter carried by a flexible elongation device and / or other device). The positioning sensor is not limited to optical fiber and may be any type of sensor capable of sensing acoustic signals, including ultrasonic receivers (e.g., as a standalone receiver or as part of a transceiver), piezoelectric devices, microphones, etc. Various examples of window shapes, positioning sensors, and tool configurations are described below.

[0044] Figure 4BA top view is shown of a portion of the distal portion of a medical tool 270 (e.g., medical tool 166), which may be able to extend from, rotate within, bend relative to, or otherwise move relative to a flexible elongation device (e.g., flexible elongation device 152). The medical tool 270 may also be used with other types of medical devices, including rigid elongation 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 elongation device 273 comprising 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 a region distal to the tool member 272. In some examples, the tool member 272 may be a needle, and the elongation device may be a stylet. In this example, the positioning sensor 274 (e.g., positioning sensor 167) may extend within the tool body 277. In some examples, the positioning sensor 274 may include an optical fiber carrying signals (e.g., acoustic signals) received from a transmitter between the proximal and distal portions of the medical tool 270. A window 276 may be formed at the distal portion of the tool body 277. The window 276 may be an acoustic window for transmitting signals (e.g., acoustic signals from an ultrasound transmitter), while the surrounding tool body 277 may at least partially or completely absorb signals such as acoustic signals. In some examples, the window 276 may be a hole through a wall of the tool body 277. In other examples, the window 276 may be a region within the wall of the tool body 277 formed or filled with a material different from the material forming the wall, such as a material that is more capable of transmitting signals without attenuation or absorption compared to the wall material. In some examples, a thermoplastic such as polyether block amide may be used to fill the window. For example, a positioning sensor 274 at a remote location can be exposed by window 276 to receive signals generated from multiple directions by a signal transmitter (e.g., a signal transmitter carried by a flexible elongation device and / or other device). The positioning sensor is not limited to optical fiber and can be any type of sensor capable of sensing acoustic signals, including ultrasonic receivers (e.g., as a standalone receiver or as part of a transceiver), piezoelectric devices, microphones, etc. Various examples of window shapes, positioning sensor configurations, and tool configurations are described below.

[0045] For some medical procedures, providing real-time visualization of medical tools positioned within or near the target tissue can be beneficial. For example, a medical tool can be delivered within the imaging field of view of an ultrasound imaging instrument to provide direct visualization of the tool in the target tissue. In other examples, the position and / or orientation of the tool may be outside the imaging field of view, but real-time visualization of the tool relative to the imaged target tissue can still be useful. To determine the position and / or orientation of the tool relative to the imaged tissue, the tool can be positioned relative to a reference frame of the imaged tissue, and the current and / or previous positions of the tool relative to the imaged tissue can be marked or displayed.

[0046] Figure 5 This is a flowchart illustrating a method 200 for positioning a medical instrument. Method 200 is shown as a set of operations or processes that can be performed in the same or different order as shown. In some examples of this method, one or more of the processes shown may be omitted. Additionally, Figure 5 One or more processes not explicitly shown may be included before, after, between, or as part of the shown processes. In some examples, one or more processes of method 200 may be implemented at least in part by the control system executing code stored on a non-transitory tangible machine-readable medium, which, when run by one or more processors (e.g., the processor of control system 612), may cause one or more processors to execute one or more processes.

[0047] At processing point 202, a tool (e.g., medical tool 166) can be positioned relative to a signal transmitter supported by a device (e.g., flexible elongation device 152), to which the tool is movably coupled. In some examples, a positioning sensor (e.g., positioning sensor 167) near the tip of the medical tool can detect a signal from the signal transmitter, and the detected signal can be used to triangulate the position of the positioning sensor and thus the tip of the tool relative to the signal transmitter. For example, the tool may include a positioning sensor comprising an ultrasonic transducer, and the signal transmitter may be an array of ultrasonic transducers positioned at a known location on the flexible elongation device. Ultrasonic signals in the form of sound waves can be emitted from the ultrasonic transducer array and received at an ultrasonic transducer coupled to the tool. The ultrasonic transducer can register the reception of the ultrasonic signal. Information from the ultrasonic transducer can be used to triangulate the position of an optical sensor (and / or a portion of the medical tool having a known configuration relative to the optical sensor) relative to the ultrasonic transducer array.

[0048] Figure 6This is a flowchart illustrating a method 250 for positioning a medical tool relative to a signal transmitter. Method 250 is an example of a technique that can be used to perform process 202. In this example, the positioning sensor may include an ultrasonic transducer as an optical sensor, and the signal transmitter may include an array of ultrasonic transducers. At process 252, ultrasonic signals may be emitted from one or more elements of the ultrasonic transducer array. Each element of the transducer array may have a known position and orientation relative to the other elements of the transducer array. At process 254, light may be transmitted to an optical fiber coupled to the medical tool. For example, a laser source may be coupled to the optical fiber to transmit an optical signal along the fiber to the optical sensor. In some examples, as described below, the optical sensor may include an optical interferometer, an optical resonator, or a fiber-optic sensor. At process 256, the ultrasonic signal is received at the optical sensor. For example, the optical sensor may be exposed within a window of the tool, and the acoustic signal may propagate through the window to be received by the optical sensor. At process 258, the modification of the light caused by the ultrasonic signal at the optical sensor is evaluated. For example, in the presence of an acoustic signal received at the optical sensor, the light sent to the optical sensor may undergo wavelength or spectral shift. The optical sensor can send optical data indicating the detection of the acoustic signal to an optoelectronic device for processing. At process 260, the distance between the optical sensor and the active elements of the transducer array can be determined. For example, multiple distances between the optical sensor and the active elements of the transducer array can be determined based on the travel time and known velocity of the ultrasonic signal. At process 262, the optical sensor can be positioned relative to the transducer array. For example, the position of the optical sensor relative to the transducer array can be triangulated based on the determined multiple distances and the known configuration of the transducer array.

[0049] Further reference Figure 5At processing point 204, the signal transmitter can be positioned relative to a reference frame. For example, the signal transmitter can be positioned relative to an image reference frame. In some examples, the image reference frame can be used for ultrasound images (2D or 3D) generated by the ultrasound signal transmitter. In some examples, the image reference frame can be an anatomical image (2D or 3D) of an anatomical model (e.g., a preoperative or intraoperative CT model). Positioning the signal transmitter relative to an image reference frame can include tracking the three-dimensional position of the signal transmitter using an imaging positioning system 156. For example, the position of the signal transmitter can be fixed relative to a shape sensor of the imaging positioning system extending within the flexible elongation device 152. The reference frame of the flexible elongation device 152 (and therefore the reference frame of the signal transmitter of the imaging device 161, which is part of the flexible elongation device) as measured by the imaging positioning system 156 can be registered to the image reference frame. Registration of the image reference frame and the device reference frame can include rotating, translating, or otherwise manipulating points associated with one or both of the reference frames by rigid or non-rigid transformations. In some examples, registration between an image reference frame and a device reference frame can be achieved, for example, by using point-based iterative nearest-neighbor (ICP) techniques or another point cloud registration technique as described in U.S. Patent Application Publications Nos. 2018 / 0240237 and 2018 / 0235709, which are incorporated herein by reference in their entirety.

[0050] At process 206, the tool can be positioned relative to a reference frame. More specifically, the position of the tool can be referenced to the reference frame based on the positioning of the tool relative to the signal transmitter and the positioning of the signal transmitter relative to the reference frame. For example, if the position of the positioning sensor 167 at the distal portion of the tool 166 is known relative to the ultrasound transducer of the imaging device 161 as described in process 202, and if the position of the ultrasound transducer is known relative to the image reference frame as described in process 204, the position of the positioning sensor 167 can be transformed into a position in the image reference frame. When the tool is positioned relative to the image reference frame, the positions of clinical actions, annotations, imaging, or other actions occurring in the tool reference frame can be registered to the image reference frame.

[0051] At step 207, the tool's positioning relative to a reference frame is used to perform the operation. For example, at step 208, the anatomical model in the reference frame can be marked at the location where the tool will intervene. For example, the preoperative anatomical model can be annotated to indicate the location of the clinical intervention, the location of the anatomical condition, or another movement or observation of the tool. In some examples, the user can add virtual markers to areas where biopsies or treatments have been performed to enhance the user's sense of location within the patient's anatomy. The virtual markers, along with the displayed model, can be virtually rotated to provide the user with an understanding of the markers' position relative to the three-dimensional anatomy, target tissue, or lesion. In some examples, the model can be annotated with tissue boundary markers such as lymph node boundaries. In some examples, the model can be annotated with tool trajectories. In some examples, step 208 can be omitted.

[0052] At processing 210, an integrated image of the tool and the anatomical model can be displayed in a reference frame. For example, a preoperative 2D anatomical image or a 3D model (e.g., a CT model) can be displayed, and the image or graphical representation of the tool can be overlaid or otherwise displayed relative to the displayed model. In some examples, processing 210 can be omitted.

[0053] At processing 212, an integrated image of the tool and the image generated by the signal transmitter can be displayed. For example, an ultrasonic image generated from data from an ultrasonic transducer carried by the flexible elongation device 152 can be displayed, and the image or graphical representation of the tool 166 can be superimposed on or otherwise displayed relative to the displayed model. In some embodiments, processing 212 can be omitted.

[0054] The tool can be manufactured and configured to enhance its performance in medical procedures and to enable the use of positioning sensors to track its position. In various examples, the tool can be used to perform a biopsy and may include needles, forceps, brushes, or other tissue sampling or collection devices. In other examples, the tool may include an ablation tool containing a heating or freezing probe, an electroporation tool, forceps, a drug delivery device, a reference delivery device, or another type of diagnostic or therapeutic device.

[0055] Figure 7AA top view of the distal portion of a medical tool 300 (e.g., medical tool 166) is shown. This medical tool 300 may be able to extend from, rotate within, bend relative to, or otherwise move relative to a flexible elongating device (e.g., flexible elongating device 152). The medical tool 300 may also be used with other types of medical devices, including rigid elongating devices, robotic arms, etc. The medical tool 300 may include a tool body 302 and a positioning sensor 304. The tool body 302 may be formed of a rigid material that is generally resistant to bending. In this example, the medical tool 300 may be a biopsy needle including a tapered or pointed tissue-penetrating tip 303.

[0056] In this example, the positioning sensor 304 may be an optical sensor system comprising an optical fiber cable 308 and a sensor head 310 coupled to the distal end of the optical fiber cable 308. The optical fiber cable 308 may include, for example, one or more multimode optical fibers. In some examples, the optical fiber cable 308 may have a relatively small diameter, for example, approximately 80 micrometers or less. For example, the sensor head 310 may include one or more sensing elements such as a pressure sensor, which 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 whispering-gallery mode resonators. In some examples, the sensor head may be the distal portion of the optical fiber cable 308, which itself can be used as a sensing element. The sensor head 310 may be located at a known distance D1 from the tip 303 of the tool body 302. Therefore, positioning the positioning sensor allows the position of the tip at the known distance D1 to also be known. The optical sensor system may also include a light source 305, such as a laser source, which may be coupled to the proximal portion of the fiber optic cable 308 or otherwise optically communicate with the fiber optic cable 308. The optical sensor system may also include a photoelectric device 307, such as a photodetector, which converts light received from the fiber optic cable 308 into an electrical signal. Light from the light source 305 may be carried to a sensor head 310, and light may be returned from the sensor head 310 to the photoelectric device 307 for processing.

[0057] A window 306 may be formed at the distal portion of the tool body 302, and the distal end of the fiber optic 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 the 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 a distal corner 314. A passage 311 may be formed in the wall 309 to accommodate the fiber optic cable 308. In some examples, the passage 311 may be a groove, for example, formed by electrical discharge machining (EDM). In other examples, the passage 311 may be a slot that passes through the wall 309 along its entire length or a portion thereof. In various examples, the fiber optic cable 308 may be wholly or partially surrounded within the passage 311 by an acoustic potting material 316. In various examples, acoustic potting material can extend within window 306 to fill all or part of the window, thereby eliminating air gaps that may form around positioning sensor 304 during use.

[0058] Figure 7BA top view of the distal portion of a medical tool 320 (e.g., medical tool 166) is shown. This medical tool 320 may be able to extend from, rotate within, bend relative to, or otherwise move relative to a flexible elongating device (e.g., flexible elongating device 152). The medical tool 320 may also be used with other types of medical devices, including rigid elongating devices, robotic arms, etc. The medical tool 320 may be similar to the medical tool 300, but with the differences described. In this example, a window 326 may be formed at the distal portion of the tool body 302, and the distal end of the fiber optic cable 308 and / or sensor head 310 may be exposed within the window 326. The window 326 may extend through the 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 allows acoustic signals from signal transmitters (e.g., transmitters 180, 181) to bounce off the curved surface and reflect back towards the center of the window 326 where the sensor head 310 is located. Therefore, the curved distal portion 332 can enhance the acoustic signal and improve detection, which in turn improves the triangulation of the sensor head 310's position. A groove 331 can be formed in the wall 309, for example, by EDM, to accommodate the fiber optic cable 308. In this example, the groove 331 can extend distally to the tip 303 of the window 326. With the distal tip 303 approximately axially aligned with the groove 331, EDM may damage the distal tip 303 or thin the wall at the distal tip 303, reducing its stress resistance. The fiber optic cable 308 can be completely or partially encased within the groove 331 by an acoustic potting material 316.

[0059] Figure 7CA top view of the distal portion of a medical tool 340 (e.g., medical tool 166) is shown. This medical tool 340 can extend from, rotate within, bend relative to, or otherwise move relative to a flexible elongating device (e.g., flexible elongating device 152). The medical tool 340 can also be used with other types of medical devices, including rigid elongating devices, robotic arms, etc. The medical tool 340 can be similar to the medical tool 300, but with the differences described. In this example, a window 346 can be formed at the distal portion of the tool body 302, and the distal end of the fiber optic cable 308 and / or sensor head 310 can be exposed within the window 346. The window 346 can extend through a wall 309 of the tool body 302. In this example, the window 346 may include a curved distal portion 352. A groove 351 can be formed in the wall 309, for example, by laser cutting, to accommodate the fiber optic cable 308. In this example, the slot 351 may terminate at the window 346 and not extend distally to avoid damaging the sharp tip 303. The fiber optic cable 308 may be completely or partially encased within the slot 351 by acoustic potting material 316.

[0060] Figure 7D A side view of the distal portion of a medical tool 360 (e.g., medical tool 166) is shown. This medical tool 360 is capable of extending from, rotating within, bending relative to, or otherwise moving relative to a flexible elongating device (e.g., flexible elongating device 152). The medical tool 360 can also be used with other types of medical devices, including rigid elongating devices, robotic arms, etc. The medical tool 360 can be similar to the medical tool 300, but with the differences described. A window 366 may be formed at the distal portion of the tool body 302, and the distal end of the fiber optic 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 the alignment with the tip 303 of the tool 360. In some examples, such as... Figure 7D As shown, window 366 can be rotated approximately 90 degrees from alignment with tip 303. A groove 371 can be formed in wall 309, for example, by EDM, to accommodate fiber optic cable 308. In this example, groove 371 can also extend distally from window 326, and the groove can also be offset from alignment with tip 303. In the case that groove 371 is offset from distal tip 303, EDM used to form the groove can avoid damaging distal tip 303. Fiber optic cable 308 can be completely or partially surrounded within groove 371 by acoustic potting material 316.

[0061] Figure 8A and Figure 8BA relative side view of the distal portion of a medical tool 380 (e.g., medical tool 166) is shown. This medical tool 380 may be able to extend from, rotate within, bend relative to, or otherwise move relative to a flexible elongating device (e.g., flexible elongating device 152). The medical tool 380 may also be used with other types of medical devices, including rigid elongating 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 is generally resistant to bending. In this example, the medical tool 380 may be a biopsy needle including a tapered or pointed tip 383 and a bevel 384 surrounding an opening 385 leading to a channel 388 through which the needle passes. The medical tool 380 may be similar to the medical tool 300, but with additional differences as described. A window 386 may be formed at the distal portion of the tool body 382, ​​and the distal end of the fiber optic 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, such as Figure 8A and Figure 8B As shown, window 386 can be rotated approximately 90 degrees from alignment with tip 383. The asymmetric tool body 382 is configured such that the wall of tool body 382 opposite window 386 has a gradually narrowing profile 387, ensuring that the wall opposite window 386 does not obstruct acoustic signals from reaching the window. A groove 391 can be formed in wall 389, for example, by EDM, to accommodate fiber optic cable 308. In this example, groove 391 can also extend at the distal end of window 386, and the groove can also be offset from alignment with tip 383. In the case where groove 391 is offset from the distal tip 383, the EDM used to form the groove can avoid damaging the distal tip 383.

[0062] Figure 9A A top view of a medical tool 400 (e.g., medical tool 166) is shown, which can extend from, rotate within, bend relative to, or otherwise move relative to a flexible elongating device (e.g., flexible elongating device 152). The medical tool 400 can also be used with other types of medical devices, including rigid elongating devices, robotic arms, etc. Figures 9B to 9DA cross-sectional view of a medical tool 400 is shown below. The medical tool 400 may include a tool body 402 and a positioning sensor 404. The tool body 402 may be the same as or substantially similar to any of the tool bodies disclosed herein. The positioning sensor 404 may be the same as or substantially similar to any of the positioning sensors described herein. The medical tool 400 may also include a flexible portion 408 coupled to or integrally formed with the proximal end of the tool body 402 and a tool shaft 406 coupled to or integrally formed with the 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 larger than the 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 the elongation passage 410. Figure 9C As shown, the fiber optic cable 412 of the positioning sensor can extend unconstrained or floating within the passage 410. In some examples, the fiber optic cable 412 can extend within a floating fiber optic support channel 414, which can resist kinking of the fiber optic cable and / or damage due to interaction with other tools passing through the passage 410. The fiber optic cable 412 can be fixed relative to the tool body 402, but can be allowed to piston and / or rotate longitudinally relative to the tool shaft 406 and the flexible portion 408. A passage 422 within the wall 421 of the flexible portion 408 can carry the fiber optic cable 412 between the tool shaft 406 and the tool body 402. An internal support member 416 can extend within the flexible portion 408 to prevent the fiber optic cable 412 from migrating into the central passage 420 of the flexible portion 408. The internal support member also prevents the central passage 420 from collapsing and resists kinking of the flexible portion. In some examples, the internal support member 416 may include a laser-cut hypotube comprising multiple slits or a single helical slit. In some examples, the hypotube may be attached to the inner surface 418 of the flexible portion 408 by spot welding or by tack laser welding. In some examples, the internal support member 416 may include a continuous tube formed of a flexible material such as nitinol. In some examples, the flexible internal support member 416 may include a combination of polymer and metallic materials, such as a braided metal wire structure encapsulated in a polymer tube. The continuous flexible tube or the encapsulated metal braid can provide a seal to prevent fluid or debris ingress. Additionally or alternatively, a flexible sleeve 423 may extend along the flexible portion 408 to prevent fluid or debris ingress.

[0063] Figure 10AA top view of a medical tool 500 (e.g., medical tool 166) is shown, which can extend from, rotate within, bend relative to, or otherwise move relative to a flexible elongating device (e.g., flexible elongating device 152). The medical tool 500 can also be used with other types of medical devices, including rigid elongating devices, robotic arms, etc. Figures 10B to 10D A cross-sectional view of a medical tool 500 is shown below. The medical tool 500 may include a tool body 502 and a positioning sensor 504. The tool body 502 may be the same as or substantially similar to any of the tool bodies disclosed herein. The positioning sensor 504 may be the same as or substantially similar to any of the positioning sensors described herein. The medical tool 500 may also include a flexible portion 508 coupled to or integrally formed with the proximal end of the tool body 502 and a tool shaft 506 coupled to or integrally formed with the 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 larger than the 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 the elongation passage 510. Figure 10C As shown, the fiber optic cable 512 of the positioning sensor can extend within a lumen 507 passing through the shaft wall 509. In some examples, the shaft wall 509 can protrude into the elongated passage to accommodate the lumen 507 and the fiber optic cable 512. In other examples, the fiber optic cable 512 can extend freely without being constrained by the shaft wall, as previously described. The fiber optic cable 512 can be fixed relative to the tool body 502, but can be allowed to piston-like motion and / or rotation relative to the tool shaft 506 and the flexible portion 508 in the longitudinal direction. A passage 522 within the wall 521 of the flexible portion 508 can carry the fiber optic cable 512 between the tool shaft 506 and the tool body 502. An internal support member 516 can extend within the flexible portion 508 to prevent the fiber optic cable 512 from migrating into the central passage 520 of the flexible portion 508. The internal support member 516 also prevents the central passage 520 from collapsing and resists kinking of the flexible portion. In some examples, the internal support member 516 may include a flexible polymer tube secured to the inner surface 518 of the flexible portion 508 by an adhesive. In some examples, the flexible internal support member 516 may include a combination of polymer and metallic materials, such as a braided metal wire structure encapsulated within a polymer tube secured by an adhesive. The encapsulated metal braid can provide a seal to prevent fluid or debris from entering. The flexible sleeve 523 may extend along the flexible portion 508 to prevent fluid or debris from entering.

[0064] In some examples, the process can be performed using handheld or otherwise manually controlled flexible elongation devices and tools of this disclosure. In other examples, the described devices and tools can be manipulated using a medical system. Figure 10 is a simplified diagram of a medical system 600 according to some embodiments. The medical system 600 can be adapted for, for example, surgical procedures, diagnostic (e.g., biopsy) procedures, or therapeutic (e.g., ablation, electroporation, etc.) procedures. While some embodiments of such procedures are provided herein, any references to medical devices or surgical instruments and medical methods or surgical methods are non-limiting. The systems, devices, and methods described herein can be used with animals, human cadavers, animal carcasses, parts of human or animal anatomy, non-surgical diagnostics, and for industrial systems, general-purpose or special-purpose robotic systems, and general-purpose or special-purpose robot-assisted medical systems.

[0065] like Figure 11 As shown, medical system 600 may include a manipulator assembly 602 that controls the operation of medical device 604 (e.g., medical device systems 100, 150) during various procedures performed on patient P. Medical device 604 may extend into an internal part of patient P's body via an opening in patient P's body. Manipulator assembly 602 may be a robot-assisted, non-assisted, or hybrid robot-assisted and non-assisted assembly having selectable degrees of freedom of motion that can be motorized and / or robot-assisted, and selectable degrees of freedom of motion that can be non-motorized and / or non-assisted. Manipulator assembly 602 may be mounted to and / or positioned near patient table T. A master assembly 606 allows an operator O (e.g., a surgeon, clinician, internist, or other user) to control manipulator assembly 602. In some examples, master assembly 606 allows operator O to view the procedure site or other graphical or information displays. In some examples, manipulator assembly 602 may be excluded from medical system 600, and device 604 may be directly controlled by operator O. In some examples, the manipulator component 602 can be manually controlled by operator O. Direct operator control may include various handles and operator interfaces for handheld operation of the instrument 604.

[0066] The main component 606 may be located at the surgeon's console, which is close to the patient table T where the patient P is located (e.g., in the same room as the patient table T), such as on the side of the patient table T. In some examples, the main component 606 is located away from the patient table T, such as in a different room or a different building. The main component 606 may include one or more control devices for controlling the manipulator component 602. The control devices may include any number of various input devices, such as joysticks, trackballs, scroll wheels, direction pads, buttons, data gloves, trigger guns, manual controllers, voice recognition devices, motion sensors, or presence sensors, etc.

[0067] Manipulator assembly 602 supports medical device 604 and may include a kinematic structure of links providing a setting structure. Links may include one or more non-servo-controlled links (e.g., one or more links that can be manually positioned and locked in place) and / or one or more servo-controlled links (e.g., one or more links that can be controlled in response to commands, for example, from control system 612). Manipulator assembly 602 may include a plurality of actuators (e.g., motors) that drive inputs to medical device 604 in response to commands, for example, from control system 612. Actuators may include a drive system that moves medical device 604 in various ways when coupled to it. For example, one or more actuators may advance medical device 604 into a naturally occurring or surgically created anatomical opening. Actuators may control engagement of medical device 604, for example, by moving the distal end (or any other part) of medical device 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 three degrees of rotational motion (e.g., rotation about the X, Y, Z Cartesian axes). One or more actuators may control the rotation of the medical device about its longitudinal axis. The actuators may also be used to move the engageable end effector of the medical device 604, for example, to grasp tissue in the jaws of a biopsy device, or to move or otherwise control tools inserted into the medical device 604 (e.g., imaging tools, ablation tools, biopsy tools, electroporation tools, etc.).

[0068] The medical system 600 may include a sensor system 608 having one or more subsystems for receiving information about the manipulator assembly 602 and / or the medical device 604. Such subsystems may include: a position sensor system (e.g., using an electromagnetic (EM) sensor or other type of sensor for detecting position or orientation); a shape sensor system for determining the position, orientation, velocity, rate, pose, and / or shape of the distal end of the medical device 604 and / or along one or more segments of the flexible body of the medical device 604; a visualization system 709 (e.g., using a color imaging device, infrared imaging device, ultrasound imaging device, X-ray imaging device, fluorescence microscope imaging device, computed tomography (CT) imaging device, magnetic resonance imaging (MRI) imaging device, or some other type of imaging device) for capturing images, for example, from the distal end of the medical device 604 or from some other location; and / or an actuator position sensor (e.g., a rotary transformer, encoder, potentiometer, etc.) that describes the rotation and / or orientation of the actuator controlling the medical device 604.

[0069] The medical system 600 may include a display system 610 for displaying images or representations of the procedure site and the medical device 604. The display system 610 and the main component 606 may be configured so that a physician O can control the medical device 604 and the main component 606 with a sense of telepresence.

[0070] In some embodiments, medical device 604 may include a visualization system 609, which may include an image capture component that records concurrent or real-time images of the procedure site and provides the images to an operator O via one or more displays of display system 610. The image capture component may include various types of imaging devices. The concurrent images may be, for example, two-dimensional or three-dimensional images captured by an endoscope positioned within the anatomical procedure site. In some examples, the visualization system may include an endoscope component that may be integrally or detachably coupled to medical device 604. Additionally or alternatively, a separate endoscope attached to a separate manipulator assembly may be used with medical device 604 to image the procedure site. The visualization system may be implemented as hardware, firmware, software, or a combination thereof that interacts with or is otherwise executed by one or more computer processors (e.g., control system 612).

[0071] Display system 610 can also display images of the process site and medical device, which can be captured by a visualization system. In some examples, medical system 600 provides operator O with a remote sense of presence. For example, an image captured by an imaging device at the distal portion of medical device 604 can be presented by display system 610 to provide operator O with a perception of being at the distal portion of medical device 604. Input to main component 606 provided by operator O can move the distal portion of medical device 604 in a manner corresponding to the nature of the input (e.g., the distal tip rotates to the right when the trackball rolls to the right), and cause a corresponding change in the viewing angle of the image captured by the imaging device at the distal portion of medical device 604. Thus, operator O's remote sense of presence is maintained when medical device 604 is moved using main component 606. Operator O can manipulate the manual controls of medical device 604 and main component 606 as if viewing a workspace in a substantially real-world setting, simulating the experience of physically manipulating medical device 604 from within the patient's anatomy.

[0072] In some examples, the display system 610 may present a virtual image of the procedure site created using image data recorded preoperatively (e.g., before the procedure is performed by the medical device systems 100, 150) or intraoperatively (e.g., simultaneously with the procedure performed by the medical device systems 100, 150), such image data being, for example, image data created using computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET), fluorescence microscopy, thermal imaging, ultrasound, optical coherence tomography (OCT), thermal imaging, impedance imaging, laser imaging, nanotube X-ray imaging, etc. The virtual image may include two-dimensional, three-dimensional, or higher-dimensional images (e.g., including information based on time or rate). In some examples, one or more models are created based on the preoperative or intraoperative image dataset, and the virtual image is generated using one or more models.

[0073] In some examples, for the purpose of image-guided medical procedures, the display system 610 can display a virtual image generated based on the position of the tracking medical device 604. For example, the tracking position of the medical device 604 can be registered (e.g., a dynamic reference) with a model generated using preoperative or intraoperative images, where different portions of the model correspond to different locations of the patient's anatomy. As the medical device 604 moves through the patient's anatomy, the registration is used to determine the portions of the model corresponding to the position and / or viewpoint of the medical device 604, and the determined portions of the model are used to generate a virtual image. This can be accomplished to present a virtual image of the internal procedure site to the operator O from the viewpoint of the medical device 604 corresponding to its tracking position.

[0074] The medical system 600 may further include a control system 612, which may include processing circuitry to implement some or all of the methods or functions discussed herein. The control system 612 may include at least one memory 616 and at least one processor 714 for controlling the operation of the manipulator assembly 602, the medical device 604, the main assembly 606, the sensor system 608, and / or the display system 610. The control system 612 may include instructions (e.g., a non-transitory machine-readable medium storing instructions) that, when executed by at least one processor, configure one or more processors to implement some or all of the methods or functions discussed herein. Although the control system 612... Figure 11 While shown as a single box, the control system 612 may include two or more separate data processing circuits, with some processing performed at the manipulator component 602, others at the main component 606, and so on. In some examples, the control system 612 may include other types of processing circuitry systems, such as application-specific integrated circuits (ASICs) and / or field-programmable gate arrays (FPGAs). The control system 612 may be implemented using hardware, firmware, software, or a combination thereof.

[0075] In some examples, the control system 612 may receive feedback from the medical device 604, such as force and / or torque feedback. In response to this feedback, the control system 612 may transmit a signal to the main component 606. In some examples, the control system 612 may transmit a signal instructing one or more actuators of the manipulator component 602 to move the medical device 604. In some examples, the control system 612 may transmit information about the feedback to the display system 610 for presentation or to perform other types of actions based on the feedback.

[0076] Control system 612 may include a virtual visualization system to provide navigational assistance to operator O when controlling medical device 604 during image-guided medical procedures. Virtual navigation using the virtual visualization system may be based on a preoperative or intraoperative dataset of the acquired anatomical pathways of patient P. Control system 612 or a separate computing device may, in conjunction with operator input or alone, use programmed instructions to transform recorded images into a model of the patient's anatomy. The model may include a segmented two-dimensional or three-dimensional synthetic representation of a portion or entire anatomical organ or region. The image dataset may be associated with the synthetic representation. The virtual visualization system may obtain sensor data from sensor system 608 for calculating the (e.g., approximate) position of medical device 604 relative to the anatomical structures of patient P. Sensor system 608 may be used to register and display medical device 604 with and together with images recorded preoperatively or intraoperatively. For example, PCT disclosure WO 2016 / 191298 (published December 1, 2016, entitled "Systems and Methods of Registration for Image Guided Surgery") discloses an example system, which is incorporated herein by reference in its entirety.

[0077] During the virtual navigation process, sensor system 608 can be used to calculate the (e.g., approximate) position of medical device 604 relative to the anatomical structure of patient P. This position can be used to generate both a macroscopic (e.g., external) tracking image of the anatomical structure of patient P and a virtual internal image of the anatomical structure of patient P. The system may include one or more electromagnetic (EM) sensors, fiber optic sensors, and / or other sensors to register the medical device with and display together with preoperatively recorded medical images. For example, U.S. Patent No. 8,900,131 (filed May 13, 2011, entitled “Medical System Providing Dynamic Registration of a Model of an Anatomic Structure for Image-Guided Surgery”), which is incorporated herein by reference in its entirety.

[0078] The medical system 600 may also include operating and support systems (not shown), such as lighting systems, steering and maneuvering control systems, flushing 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 operating room, as well as other factors. Multiple master assemblies may be located in the same location, or they may be positioned in different locations. Multiple master assemblies may allow more than one operator to control one or more manipulator assemblies in various combinations.

[0079] Figure 12A This is a simplified diagram of a medical device system 700 according to some embodiments. The medical device system 700 includes a flexible elongation device 702 (e.g., flexible elongation device 152), a drive unit 704, and a medical tool 826, which together serve as an example of a medical device 604 of the medical system 600. See also... Figure 11 As described, the medical system 600 can be a robot-assisted system, a non-robot-assisted system, or a hybrid robot-assisted and non-robot-assisted system. Figure 12A The diagram also shows a visualization system 731, a tracking system 730, and a navigation system 732, which are example components of the control system 612 of the medical system 600. In some examples, the medical device system 700 can be used in non-robot-assisted exploration procedures or in procedures involving conventionally manual operation of medical devices (e.g., endoscopy). The medical device system 700 can be used to collect (e.g., measure) a set of data points corresponding to positions within the anatomical passage of a patient (e.g., patient P).

[0080] The extension device 702 is coupled to the drive unit 704. The extension device 702 includes a channel 721 through which a medical instrument 726 can be inserted. The extension device 702 navigates within the patient's anatomy to deliver the medical instrument 726 to the procedure site. The extension 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 outer diameter of approximately 3 mm. Other flexible bodies may have larger or smaller outer diameters.

[0081] The medical device system 700 may include a tracking system 730 for determining the position, orientation, velocity, rate, pose, and / or shape of a flexible body 716 at its distal end 718 and / or along one or more segments 724 of the 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 (e.g., 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... Figure 1 Part of the control system 612 shown.

[0082] The tracking system 730 can use a shape sensor 722 to track one or more of the distal ends 718 and / or segments 724 of the flexible body 716. The shape sensor 722 may include an optical fiber aligned with the flexible body 716 (e.g., disposed within an internal channel of the flexible body 716 or mounted externally along the flexible body 716). In some examples, the optical fiber may have a diameter of approximately 200 μm. In other examples, the diameter may be larger or smaller. The optical fiber of the shape sensor 722 can form an optical fiber bending sensor for determining the shape of the flexible body 716. An optical fiber including a fiber Bragg grating (FBG) can be used to provide strain measurements in one or more dimensions of the structure. Various systems and methods for monitoring the shape and relative position of an optical fiber in three dimensions, applicable to various embodiments, are described in U.S. Patent Application Publication No. 2006 / 0013523 (filed July 13, 2005, entitled "Fiber optic position and shape sensing device and method relating thereto"); U.S. Patent No. 7,772,541 (filed March 12, 2008, entitled "Fiber Optic Position and / or Shape Sensing Based on Rayleigh Scatter"); and U.S. Patent No. 8,773,650 (filed September 2, 2010, entitled "Optical Position and / or Shape Sensing"), all of which are incorporated herein by reference in their entirety. In some embodiments, the sensor may employ other suitable strain sensing techniques, such as Rayleigh scattering, Raman scattering, Brillouin scattering, and fluorescence scattering.

[0083] In some examples, other techniques may be used to determine the shape of the flexible body 716. For example, the shape of the flexible body 716 may be reconstructed over time intervals (e.g., when the flexible body 716 is advanced or retracted within a patient's anatomy) using the history of the position and / or pose of the distal end 718 of the flexible body 716. In some examples, the tracking system 730 may alternatively and / or additionally use a position sensor system 720 to track the distal end 718 of the flexible body 716. The position sensor system 720 may be a component of an EM sensor system, wherein the position sensor system 720 includes one or more position sensors. Although the position sensor system 720 is shown near the distal end 718 of the flexible body 716 to track the distal end 718, the number and position of the position sensors in 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 can withstand externally generated electromagnetic fields. Each coil of the position sensor system 720 may generate an induced electrical signal having characteristics that depend on the position and orientation of the coil in relation to the externally generated electromagnetic field. The position sensor system 720 can measure one or more position coordinates and / or one or more orientation angles associated with one or more portions of the flexible body 716. In some examples, the position sensor system 720 can be configured and positioned to measure six degrees of freedom, such as three position coordinates X, Y, and Z, and three orientation angles indicating pitch, yaw, and roll of a reference point. In some examples, the position sensor system 720 can be configured and positioned to measure five degrees of freedom, such as three position coordinates X, Y, and Z, and two orientation angles indicating pitch and yaw of a reference point. Further description of the position sensor system applicable to some embodiments is provided in U.S. Patent No. 6,380,732 (filed August 11, 1999, entitled "Six-Degree of Freedom Tracking System Having a Passive Transponder on the Object Being Tracked"), which is incorporated herein by reference in its entirety.

[0084] In some implementations, the tracking system 730 may alternatively and / or additionally rely on a set of pose, position, and / or orientation data stored at points for the elongation device 702 and / or medical instrument 726, captured during one or more cycles of alternating movement (e.g., breathing). This stored data can be used to develop shape information about the flexible body 716. In some examples, a series of position sensors (not shown) (e.g., EM sensors such as those in position sensor 720 or some other type of position sensor) may be positioned along the flexible body 716 and used for shape sensing. In some examples, data history acquired during the procedure from one or more of these position sensors can be used to represent the shape of the elongation device 702, particularly where the anatomical passage is typically static.

[0085] Figure 12B This is a simplified diagram of a medical tool 726 within an elongation device 702 according to some embodiments. The flexible body 716 of the elongation device 702 may include a 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, aspiration, electroporation, etc. The medical tool 726 may be deployed through the channel 721 of the flexible body 716 and operate at a procedure site within an anatomical structure. The medical tool 726 may be, for example, an image capture probe, a biopsy tool (e.g., a needle, gripper, brush, etc.), an ablation tool (e.g., a laser ablation tool, a radiofrequency (RF) ablation tool, a cryoablation tool, a thermal ablation tool, a heated liquid ablation tool, etc.), an electroporation tool, and / or another surgical tool, diagnostic tool, or therapeutic tool. In some examples, the medical tool 726 may include an end effector with a single working member, such as a scalpel, a blunt blade, an optical fiber, an electrode, etc. Other end effector types may include, for example, forceps, grippers, scissors, sutures, applicators, etc. Other end effectors may also include electrically activated end effectors, such as electrosurgical electrodes, transducers, sensors, etc.

[0086] Medical tool 726 may be a biopsy tool for removing sample tissue or cells from a target anatomical location. In some examples, the biopsy tool is a flexible needle. The biopsy tool may also include a sheath that can surround the flexible needle to protect the needle and the inner surface of the channel 721 when the biopsy tool is within the channel 721. Medical tool 726 may be an image capture probe including a distal portion having a stereo or single-field-of-view camera that can be positioned at or near the distal end 718 of the flexible body 716 for capturing images (e.g., still images or video images). The captured images may be processed by visualization system 731 for display and / or provided to tracking system 730 to support tracking of one or more of the distal end 718 and / or segments 724 of the flexible body 716. The image capture probe may include a cable for transmitting the captured image data, coupled to an imaging device at the distal portion of the image capture probe. In some examples, the image capture probe may include a bundle of optical fibers, such as a fiber optic endoscope, coupled to an imaging device more proximal to the visualization system 731. The image capture probe may be monospectral or multispectral, capturing image data from one or more of the visible, near-infrared, infrared, and / or ultraviolet spectra. 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, fluorescein microscopy, CT, MRI, or other types of imaging techniques.

[0087] In some examples, an image capture probe is inserted within the flexible body 716 of the elongation device 702 to facilitate visual navigation of the elongation device 702 to the procedure site, and then the image capture probe is replaced within the flexible body 716 with another type of medical instrument 726 for performing the procedure. In some examples, the image capture probe may be located within the flexible body 716 of the elongation device 702 together with another type of medical instrument 726 to facilitate simultaneous image capture and tissue intervention, for example, within the same channel 721 or in separate channels. The medical instrument 726 may be advanced from an opening in the channel 721 to perform the procedure (or some other function) and then retracted into the channel 721 when the procedure is complete. The medical instrument 726 may be removed from the proximal end 717 of the flexible body 716 or along the flexible body 716 from another optional instrument port (not shown).

[0088] In some examples, the extension device 702 may include integrated imaging capabilities instead of utilizing a removable image capture probe. For example, the imaging device (or fiber bundle) and light emitter may be located at the distal end 718 of the extension device 702. The flexible body 715 may include one or more dedicated channels carrying cables and / or optical fibers between the distal end 718 and the visualization system 731. Here, the medical device system 700 can perform imaging and tooling operations simultaneously.

[0089] In some examples, the medical tool 726 is capable of controlled engagement. The medical tool 726 may house a cable (also referred to as a traction cable), linkage, or other actuation controls (not shown), extending between its proximal and distal ends to controllably bend the distal end of the medical tool 726, such as those discussed herein with respect to the flexible elongation device 702. The medical tool 726 may be coupled to the drive unit 704 and the manipulator assembly 602. In these examples, the elongation device 702 may be excluded from the medical device system 700, or may be a flexible device without controlled engagement. Steering maneuvers or tools suitable for some embodiments are described in further detail in U.S. Patent No. 7,316,681 (filed October 4, 2005, entitled "Articulated Surgical Instrument for Performing Minimally Invasive Surgery with Enhanced Dexterity and Sensitivity") and U.S. Patent No. 9,259,274 (filed September 30, 2008, entitled "Passive Preload and Capstan Drive for Surgical Instruments"), which are incorporated herein by reference in their entirety.

[0090] The flexible body 716 of the elongation device 702 may also, or alternatively, be accommodated between the drive unit 704 and the distal end 718 to controllably bend the distal end 718 (e.g., by means of...). Figure 12A The dashed line depicting the distal end 718 (shown as 719) represents cables, linkages, or other steering control mechanisms (not shown). In some examples, at least four cables are used to provide independent up-and-down steering control to control the pitch of the distal end 718 and left-and-right steering control to control the yaw of the distal end 718. In these examples, the flexible elongation device 702 may be a steerable conduit. Examples of steerable conduits suitable for some embodiments are described in detail in PCT Publication WO 2019 / 018736 (published January 24, 2019, entitled "Flexible Elongate Device Systems and Methods"), which is incorporated herein by reference in its entirety.

[0091] In embodiments where the elongation device 702 and / or medical tool 726 is actuated by a robot-assisted component (e.g., manipulator assembly 602), the drive unit 704 may include a drive input removably coupled to and receiving power from a drive element (e.g., an actuator) of the robot-assisted component. In some examples, the elongation device 702 and / or medical tool 726 may include gripping features, manual actuators, or other components for manually controlling the movement of the elongation device 702 and / or medical tool 726. The elongation device 702 may be steerable, or alternatively, it may be non-steerable, without an integrated mechanism for operator control of bending of the distal end 718. In some examples, one or more channels 721 (which may also be referred to as lumens) may be defined by the inner wall of the flexible body 716 of the elongation device 702, through which the medical tool 726 may be deployed and used at a target anatomical location.

[0092] In some examples, medical device system 700 (e.g., extension device 702 or medical tool 726) may include flexible bronchial instruments, such as bronchoscopes or bronchial tubes, for the examination, diagnosis, biopsy, and / or treatment of the lungs. Medical device system 700 may also be adapted to navigate and treat other tissues via naturally occurring or surgically created access channels in any of a variety of anatomical systems, including the colon, intestine, kidneys and renal calyces, brain, heart, and the circulatory system, including the vascular system.

[0093] Information from tracking system 730 can be sent to navigation system 732, where it can be combined with information from visualization system 731 and / or a preoperatively acquired model to provide real-time location information to physicians, clinicians, surgeons, or other operators. In some examples, the real-time location information can be displayed on display system 610 for controlling medical device system 700. In some examples, navigation system 732 can utilize the location information as feedback for locating medical device system 700. Various systems for registering and displaying surgical instruments and surgical images using fiber optic sensors, applicable to some embodiments, are provided in U.S. Patent No. 8,900,131 (filed May 13, 2011, entitled “Medical System Providing Dynamic Registration of a Model of an Anatomic Structure for Image-Guided Surgery”), which is incorporated herein by reference in its entirety.

[0094] In the description, specific details of some examples have been set forth. Many specific details have been set forth to provide a thorough understanding of the examples. However, it will be apparent to those skilled in the art that some examples can be practiced without some or all of these specific details. The specific examples disclosed herein are intended to be illustrative and not restrictive. Those skilled in the art can implement other elements, though not specifically described herein, that are within the scope and spirit of this disclosure.

[0095] Where feasible, elements described in detail with reference to an example, implementation, or application may optionally be included 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 an example but not with reference to a second example, that element may still be claimed to be included in that second example. Therefore, to avoid unnecessary repetition in the following description, one or more elements shown and described in association with an example, implementation, or application may be incorporated into other examples, implementations, or aspects unless otherwise specifically described, unless the one or more elements would render the example or implementation ineffective, or unless two or more elements provide conflicting functionality.

[0096] Any changes and other modifications to the described apparatus, instruments, and methods, as well as any other application of the principles of this disclosure, are fully contemplated as would normally occur to those skilled in the art to which this disclosure pertains. In particular, it is fully anticipated that features, components, and / or steps described with respect to one example can be combined with features, components, and / or steps described with respect to other examples of this disclosure. Furthermore, the dimensions provided herein are for specific examples, and it is contemplated that the concepts of this disclosure can be realized using different sizes, dimensions, and / or ratios. To avoid unnecessary descriptive repetition, one or more components or actions described according to one illustrative example may be used or omitted (if applicable) in other illustrative examples. For the sake of brevity, numerous iterations of these combinations will not be described separately. For simplicity, in some cases, the same reference numerals are used throughout the drawings to refer to the same or similar components.

[0097] The systems and methods described herein can be applied to imaging in any of a variety of anatomical systems via naturally occurring or surgically created connection channels, including the lungs, colon, intestines, stomach, liver, kidneys and renal calyces, brain, heart, and the circulatory system, including the vascular system. While some examples of medical procedures are provided herein, any references to medical devices or surgical instruments, and medical or surgical methods, are non-limiting. For example, the devices, systems, and methods described herein can be used for non-medical purposes, including industrial use, general robotic use, and sensing or manipulating non-tissue artifacts. Other example applications involve cosmetic improvements, imaging of human or animal anatomy, collecting data from human or animal anatomy, and training medical or non-medical personnel. Additional example applications include procedures for handling tissue removed from human or animal anatomy (without returning it to the human or animal anatomy) and for performing procedures on human or animal cadavers. Furthermore, these techniques can also be used in surgical and non-surgical medical treatment or diagnostic procedures.

[0098] The methods described herein are shown as a collection of operations or processes. Not all processes shown will be executed in all examples of the methods. Additionally, one or more processes not explicitly shown or described may be included before, after, between, or as part of an example process. In some examples, one or more processes may be executed by a control system (e.g., control system 612), or may be implemented at least in part in the form of executable code stored on a non-transitory tangible machine-readable medium, which, when run by one or more processors (e.g., processor 614 of control system 612), may cause one or more processors to execute one or more processes.

[0099] One or more components of the embodiments discussed in this disclosure (e.g., control system 612) can be implemented in software to execute on one or more processors of a computer system. The software may include code that, when executed by one or more processors, configures the processors to perform the various functions discussed herein. The code may be stored in a non-transitory computer-readable storage medium (e.g., memory, magnetic storage device, optical storage device, solid-state storage device, etc.). The computer-readable storage medium may be part of a computer-readable storage device, such as electronic circuitry, a semiconductor device, a semiconductor memory device, a read-only memory (ROM), flash memory, an erasable programmable read-only memory (EPROM); a floppy disk, CD-ROM, optical disk, hard disk, or other storage device. The code may be downloaded to the computer-readable storage medium for storage via a computer network such as the Internet, an intranet, etc. The code may be executed by any of a variety of centralized or distributed data processing architectures. The programming instructions of the code may be implemented as multiple separate programs or subroutines, or they may be integrated into multiple other aspects of the system described herein. Components of the computing system discussed herein may be connected using wired and / or wireless connections. In some examples, wireless connectivity can use wireless communication protocols such as Bluetooth, Near Field Communication (NFC), Infrared Data Association (IrDA), HomeRF, IEEE 802.11, Digital Enhanced Cordless Telecommunications (DECT), and Wireless Medical Telemetry Service (WMTS).

[0100] Note that the processing and display presented may not inherently relate to any particular computer or other device. Various general-purpose systems may be used with programs based on the teachings herein, or it may prove convenient to construct more specialized devices to perform the described operations. The necessary structures for various such systems will appear as elements in the claims. Furthermore, examples of the invention are not described with reference to any particular programming language. It should be understood that the teachings of the invention described herein can be implemented using various programming languages.

[0101] In some cases, well-known methods, processes, components, and circuits are not described in detail to avoid unnecessarily obscuring aspects of the examples. This disclosure describes various instruments, instrument parts, and anatomical structures based on their state in three-dimensional space. As used herein, the term "position" refers to the location of an object or part of an object in three-dimensional space (e.g., three translational degrees of freedom along Cartesian x-, y-, and z-coordinates). As used herein, the term "orientation" refers to the rotational placement of an object or part of an object (three rotational degrees of freedom—e.g., roll, pitch, and yaw). As used herein, the term "pose" refers to the position of an object or part of an object in at least one translational degree of freedom and the orientation of that object or part of an object in at least one rotational degree of freedom (up to six total degrees of freedom). As used herein, the term "shape" refers to the set of poses, positions, or orientations measured along an object. As used herein, the term "distal" refers to a position closer to the process site, and the term "proximal" refers to a position further away from the process site. Therefore, when an instrument is designed to perform a process, the distal portion or distal end of the instrument is closer to the process site than the proximal portion or proximal end of the instrument.

[0102] While certain exemplary examples of the invention have been described and shown in the accompanying drawings, it should be understood that such examples are merely illustrative and do not limit the scope of the invention, and that the examples of the invention are not limited to the specific constructions and arrangements shown and described, as various other alternatives, modifications and equivalents will be understood by those skilled in the art.

Claims

1. A system comprising: A flexible elongation device, comprising one or more signal transmitters; A tool configured to extend from the distal end of the flexible elongation device, the tool comprising: The main body of the window is limited; and A positioning sensor coupled to the body portion, at least a portion of the positioning sensor being exposed by the window to receive signals from the one or more signal transmitters through the window; and A control system configured to determine the position of the tool based on signals received by the positioning sensor from the one or more signal transmitters.

2. The system according to claim 1, wherein, The one or more signal transmitters include ultrasonic transducers, the positioning sensor includes optical fibers, and the signals include acoustic signals.

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

4. The system according to claim 1, wherein, The one or more signal transmitters are located on the distal portion of the flexible elongation device.

5. The system according to claim 1, wherein, The one or more signal transmitters include a forward-facing linear transducer array.

6. The system according to claim 1, wherein, The one or more signal transmitters include a forward-facing ring transducer array.

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

8. The system according to claim 1, wherein, The positioning sensor includes optical fibers.

9. The system according to claim 1, wherein, The positioning sensor includes an ultrasonic receiver.

10. The system according to claim 1, wherein, The tools include biopsy needles.

11. The system according to claim 1, wherein, The tool includes an imaging device.

12. The system according to claim 1, wherein, The tool includes an ablation device.

13. The system according to claim 1, wherein, The tool includes an electroporation device.

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

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

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

17. The system according to claim 16, wherein, The proximal flexible section includes multiple slits.

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

19. The system according to claim 16, wherein, The window is located in the distal rigid section.

20. The system according to claim 1, wherein, The window includes a curved distal edge.

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

22. The system according to claim 1, wherein, The optical fiber path extends near the window, within a groove in the wall of the tool.

23. The system according to claim 22, wherein, The grooves in the wall of the tool are formed by electrical discharge machining or laser cutting.

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

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

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

27. The system according to claim 1, wherein, The tool includes an internal support member that defines a central passageway.

28. The system according to claim 27, wherein, The internal support components include polymer tubes or metal tubes.

29. The system according to claim 27, wherein, The internal support component includes a laser-cut hyaluronic acid tube.

30. The system according to claim 1, wherein, The tool includes a tool shaft coupled to the body portion.

31. The system according to claim 30, wherein, The wall of the tool shaft includes a sensor cavity sized to receive the positioning sensor.

32. The system according to claim 30, wherein, The wall of the tool shaft surrounds the tool shaft passage, and the positioning sensor extends within the tool shaft passage.

33. The system according to claim 1, wherein, The one or more signal transmitters include a plurality of spaced-apart signal transmitters, and the control system is configured to determine the position of the tool by triangulation of signals propagated by the plurality of spaced-apart signal transmitters.

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

35. The system of claim 1, further comprising a laser for transmitting light to the positioning sensor.

36. The system of claim 1 further includes a photodetector for detecting received light having a wavelength offset by signals from the one or more signal transmitters.

37. The system according to claim 1, wherein, The tool includes a tool component and an extension device sized to extend within the tool component, wherein the extension device includes the body portion defining the window.

38. A medical device comprising: The body portion, in which an acoustic window is defined; as well as A fiber optic positioning sensor extends into the acoustic window. The acoustic window is configured to allow ultrasonic signals to pass through, and the body portion surrounding the acoustic window is configured to absorb the ultrasonic signals.

39. The medical instrument according to claim 38, wherein, The medical tool also includes a tissue-penetrating tip configured to perform a tissue biopsy.

40. The medical instrument according to claim 38, wherein, The medical tool also includes an imaging device.

41. The medical instrument according to claim 38, wherein, The medical tools also include ablation devices.

42. The medical instrument according to claim 38, wherein, The medical tool also includes an electroporation device.

43. The medical instrument according to claim 38, wherein, The medical tool includes a proximal flexible segment and a distal rigid segment.

44. The medical instrument according to claim 43, wherein, The proximal flexible section includes multiple slits.

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

46. ​​The medical instrument according to claim 43, wherein, The acoustic window is located in the distal rigid section.

47. The medical instrument according to claim 38, wherein, The acoustic window includes a curved distal edge.

48. The medical instrument according to claim 38, wherein, The optical fiber path extends near the acoustic window and within the wall of the body portion.

49. The medical instrument according to claim 38, wherein, The acoustic window is aligned with the distal tip of the body portion.

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

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

52. The medical device of claim 38 further includes an internal support member defining a central access route.

53. The medical instrument according to claim 52, wherein, The internal support components include polymer tubes or metal tubes.

54. The medical instrument according to claim 52, wherein, The internal support component includes a laser-cut hyaluronic acid tube.

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

56. The medical instrument according to claim 55, wherein, The wall of the tool shaft includes a sensor cavity sized to receive the fiber optic positioning sensor.

57. The medical instrument according to claim 55, wherein, The wall of the tool shaft surrounds the tool shaft passage, and the positioning sensor extends within the tool shaft passage.

58. The medical instrument of claim 38, further comprising a tool component and an elongating device, the elongating device being sized to extend within the tool component, and wherein, The elongation device includes the body portion that defines the window.

59. A method comprising: The tool is movably coupled to the instrument, which positions the tool relative to one or more ultrasonic transducers supported by the instrument. Positioning of one or more ultrasonic transducers relative to a reference frame; as well as The tool is positioned relative to the reference frame based on its position relative to the one or more ultrasonic transducers.

60. The method according to claim 59, wherein, The reference frame is defined relative to a model of the anatomical region.

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

62. The method of claim 60, further comprising displaying an integrated image of the tool and a model of the anatomical region.

63. The method according to claim 59, wherein, Positioning the tool includes positioning the distal end of the tool.

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

65. The method according to claim 59, wherein, Positioning the tool includes emitting ultrasonic signals from one or more ultrasonic transducers and performing triangulation on the position of the tool relative to the one or more ultrasonic transducers.

66. The method according to claim 65, wherein, The ultrasonic signal passes through a window in the tool, wherein the window surrounds at least a portion of the positioning sensor.

67. The method according to claim 59, wherein, Positioning of the tool is performed relative to an ultrasonic transducer that is separate from the instrument.

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