Systems and methods for triple imaging hybrid probes

Abstract

A hybrid vision device is provided.SOLUTION: The hybrid vision device comprises an articulating elongate member comprising a proximal end and a distal end, wherein the position sensor is located at the distal end of the articulating elongate member, and a multi-modal sensing probe removably coupled to the articulating elongate member, wherein the multi-modal sensing probe comprises an ultrasound transducer and a camera located at a distal portion of the multi-modal sensing probe.SELECTED DRAWING: Figure 3

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 033,624, filed June 2, 2020, which application is incorporated herein by reference. [Background technology]

[0002]

[0002] Early diagnosis of lung cancer is important. The 5-year survival rate for lung cancer is approximately 18%, significantly lower than the next three most common cancers: breast cancer (90%), colorectal cancer (65%), and prostate cancer (99%). In 2018, a total of 142,000 deaths from lung cancer were recorded.

[0003]

[0003] When a patient is diagnosed with a suspicious lung lesion, they are referred to a physician for a biopsy of the lesion to determine whether it is malignant. If the tissue sample is identified as malignant, endobronchial treatment for lung cancer may be performed. In a typical process, preoperative imaging, such as computed tomography (CT), may be performed to identify the lesion in the patient's lung. The CT image may be used to provide anatomical location information for the lesion, such as to generate a map to guide bronchoscope navigation at the time of bronchoscopy. During bronchoscopy, a bronchoscopy system equipped with sensors, such as an electromagnetic (EM) three-dimensional (3D) sensor, can register itself to the CT image or the patient's anatomy. EM information, along with a direct visualization system (e.g., a camera), allows the physician to navigate the bronchoscope to the site of the lesion.

[0004]

[0004] When a lesion is at least partially within the airway that is captured within the view of the direct visualization system, the physician can navigate the endoscope toward the lesion and proceed to obtain a tissue biopsy of the lesion. However, when the lesion is outside the airway, the lesion is outside the view of the bronchoscope's direct visualization system, and a challenge arises. In this scenario, the lesion is not visible to the physician within the camera view, and the physician must rely on information from the EM sensor and preoperative images, which do not provide accurate, real-time location of the lesion relative to the bronchoscope. Summary of the Invention

[0005]

[0005] It is recognized herein that there is a need for a minimally invasive system capable of performing surgical or diagnostic procedures with improved visualization. The present disclosure provides systems and methods for enabling the diagnosis and treatment of early-stage lung cancer with improved real-time visualization. In particular, the present disclosure provides a bronchoscopy device with multimodal hybrid vision. A bronchoscope may integrate electromagnetic (EM) sensors, direct imaging devices, and ultrasound imaging to enable a physician to visualize tissue variations within the lungs, particularly outside the airways. For example, incorporating an ultrasound probe into the bronchoscope may enable a physician to scan an area of ​​interest and confirm the actual location of a lesion relative to the bronchoscope with improved accuracy. The provided bronchoscope may provide hybrid vision capabilities by combining the use of EM sensors, direct imaging sensors, and ultrasound sensors. It should be noted that the provided endoscopic systems can be used in a variety of minimally invasive surgical procedures, therapeutic or diagnostic procedures involving various types of tissue, including cardiac, bladder, and pulmonary tissue, as well as in other anatomical regions of a patient's body, such as the digestive system, including but not limited to the esophagus, liver, stomach, colon, and urinary tract, or the respiratory system, including but not limited to the bronchi, lungs, and various others.

[0006] In one aspect of the present disclosure, a hybrid vision device is provided. The hybrid vision device includes an articulating elongate member having a proximal end and a distal end, a first position sensor located at the distal end of the articulating elongate member, and a multimodal sensing probe removably coupled to the articulating elongate member. The multimodal sensing probe includes an ultrasound transducer and a camera located at a distal portion of the multimodal sensing probe.

[0007] In some embodiments, the multimodal sensing probe is inserted through a first lumen of the articulating elongate member. In some embodiments, the multimodal sensing probe is rotatable and extendable relative to the articulating elongate member. In some embodiments, the multimodal sensing probe is articulatable relative to the articulating elongate member.

[0008] In some embodiments, the multimodal sensing probe further comprises a second position sensor located at a distal portion of the multimodal sensing probe to track a location of the distal portion of the multimodal sensing probe. In some instances, the second position sensor, camera, and lighting device are incorporated into the distal portion of the multimodal sensing probe. In some instances, the second position sensor, camera, and lighting device are arranged in a compact configuration. In some instances, the articulating elongate member and the multimodal sensing probe are robotically controlled based at least in part on sensor data captured by the first position sensor and the second position sensor.

[0009] In some embodiments, the ultrasound transducer is an array of linear endobronchial ultrasound (EBUS) transducers. In some embodiments, the camera provides a real-time forward view and the ultrasound transducer provides a real-time lateral view. In some cases, the articulating elongate member includes a second lumen for receiving an instrument. In some instances, movement of the instrument is captured by the real-time lateral view.

[0010] In some embodiments, the articulating elongate member further comprises an imaging device located at a distal end of the articulating elongate member. In some embodiments, the multi-modal sensing probe comprises an expandable tip for contacting or sealing a passageway within the body.

[0011]

[0011] In another aspect, the present disclosure provides a hybrid vision device comprising an articulated elongate member having a distal tip portion and a bent section, an ultrasound transducer located in the distal tip portion to provide a lateral view, and a channel configured to receive an instrument, the lumen having a port located in the bent section that allows the instrument to extend out of the port along a trajectory that intersects the lateral view or ultrasound image.

[0012] In some embodiments, the articulating elongate member comprises a position sensor located at the distal tip portion. In some instances, the position sensor is incorporated into the distal tip portion to track the location of the distal tip portion. In some embodiments, the articulating elongate member comprises a camera incorporated into the distal tip portion. In some cases, the camera provides a real-time forward view. In some embodiments, the ultrasound transducer is an array of linear endobronchial ultrasound (EBUS) transducers.

[0013]

[0013] Additional aspects and advantages of the present disclosure will become readily apparent to those skilled in the art from the following detailed description, which shows and describes only exemplary embodiments of the present disclosure. As will be understood, the present disclosure is capable of other and different embodiments, and its several details can be modified in various respects, all without departing from the present disclosure. Accordingly, the drawings and description should be regarded as illustrative in nature and not restrictive.

[0014] Incorporation by Reference All publications, patents, and patent applications mentioned herein are incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference. To the extent that a publication, patent, or patent application incorporated by reference conflicts with the disclosure contained herein, the present specification is intended to supersede and / or take precedence over any such conflicting material.

[0015] The novel features of the invention are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings (also referred to herein as "Figure" and "FIG."). [Brief explanation of the drawings]

[0016] [Figure 1]

[0016] FIG. 1 illustrates an example of an assembly of an endoscopic system according to some embodiments of the present disclosure. [Figure 2]

[0017] 1A-1C illustrate examples of hybrid probes that can be extended distally beyond the distal tip of a bronchoscope, according to some embodiments of the present disclosure. [Figure 3]

[0018] 10A-10C illustrate examples of a hybrid probe that is rotated relative to a distal portion of a catheter, according to some embodiments of the present disclosure. [Figure 4]

[0019] FIG. 1 illustrates an example of an endoscope with integrated hybrid vision, according to some embodiments of the present disclosure. [Figure 5]

[0020] 1 illustrates an example of a hybrid probe with an expandable tip, according to some embodiments of the present disclosure. [Figure 6]

[0021] 1A-1C illustrate examples of hybrid probes with balloon-type tips, according to some embodiments of the present disclosure. [Figure 7]

[0022] An example user interface is shown that displays an endobronchial ultrasound (EBUS) view for real-time precise lesion location tracking, a direct video / camera view, and a virtual airway model based on preoperative images. [Figure 8]

[0023] FIG. 1 illustrates an example of a robotic bronchoscope, according to some embodiments of the present invention. [Figure 9]

[0024] FIG. 1 illustrates an example of an instrument drive mechanism that provides a mechanical and electrical interface to the handle portion of a robotic bronchoscope, according to some embodiments of the present invention. [Figure 10]

[0025] FIG. 1 illustrates an example of a distal portion of a hybrid probe with an integrated imaging and illumination device. [Figure 11]

[0026] FIG. 10 shows an example of a compact configuration of electronic elements located in the distal portion. DETAILED DESCRIPTION OF THE INVENTION

[0017]

[0027] While various embodiments of the present invention have been shown and described herein, it will be apparent to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions may occur to those skilled in the art without departing from the invention. It will be understood that various alternatives to the embodiments of the invention described herein may be employed.

[0018]

[0028] While the exemplary embodiments are primarily directed to bronchoscopes, those skilled in the art will understand that this is not intended to be limiting and that the devices described herein may also be used for other therapeutic or diagnostic procedures, as well as in other anatomical regions of a patient's body, such as the digestive system, including but not limited to the esophagus, liver, stomach, colon, and urinary tract, or the respiratory system, including but not limited to the bronchi, lungs, and various others.

[0019]

[0029] The embodiments disclosed herein can be combined in one or more of many ways to provide improved diagnosis and therapy to patients. The disclosed embodiments can be combined with existing methods and devices to provide improved treatment, such as in combination with known methods of lung disease diagnosis, surgery, and surgery on other tissues and organs. It should be understood that any one or more of the structures and steps described herein can be combined with any one or more additional structures and steps of the methods and devices described herein, and the figures and supporting text provide a description according to the embodiments.

[0020]

[0030] Although the treatment plans and definitions for diagnostic or surgical procedures described herein are presented in the context of diagnosing or operating on pulmonary disease, the methods and devices described herein can be used to treat any tissue of the body and any organ and blood vessel of the body, such as the brain, heart, lungs, intestines, eyes, skin, kidneys, liver, pancreas, stomach, uterus, ovaries, testes, bladder, ears, nose, mouth, soft tissues, such as bone marrow, fatty tissue, muscle, glandular and mucosal tissue, spinal cord and nerve tissue, cartilage, and hard biological tissues, such as teeth and bone, as well as body lumens and passageways, such as the sinuses, ureters, colon, esophagus, airways of the lungs, blood vessels, and throat.

[0021]

[0031] Whenever the terms "at least," "greater than," or "greater than or equal to" precede a first number in a series of two or more numbers, the terms "at least," "greater than," or "greater than or equal to" apply to each number in the series. For example, greater than or equal to 1, 2, or 3 is equivalent to greater than or equal to 1, greater than or equal to 2, or greater than or equal to 3.

[0022]

[0032] Whenever the terms "less than or equal to," "less than," or "less than or equal to" are placed before the first number in a series of two or more numbers, the terms "less than or equal to," "less than," or "less than or equal to" apply to each number in the series. For example, less than or equal to 3, 2, or 1 is equivalent to less than or equal to 3, less than or equal to 2, or less than or equal to 1.

[0023]

[0033] As used herein, a processor encompasses one or more processors, e.g., a single processor, or multiple processors, e.g., in a distributed processing system. A controller or processor as described herein generally includes a tangible medium for storing instructions for implementing process steps, and a processor may include, e.g., one or more of a central processing unit, programmable array logic, gate array logic, or field programmable gate array. In some cases, the one or more processors may be a programmable processor (e.g., a central processing unit (CPU), a graphics processing unit (GPU), or a microcontroller), a digital signal processor (DSP), a field programmable gate array (FPGA), and / or one or more Advanced RISC Machine (ARM) processors. In some cases, the one or more processors may be operably coupled to a non-transitory computer-readable medium. The non-transitory computer-readable medium may store logic, code, and / or program instructions executable by one or more processor units to perform one or more steps. The non-transitory computer-readable medium may include one or more memory units (e.g., removable media or external storage, such as an SD card or random access memory (RAM)). One or more of the methods or operations disclosed herein may be implemented in hardware components or a combination of hardware and software, such as, for example, an ASIC, a special purpose computer, or a general purpose computer.

[0024]

[0034] As used herein, the terms distal and proximal may generally refer to a location referenced from the device, as opposed to an anatomical reference. For example, a distal location on a bronchoscope or catheter may correspond to a proximal location on the elongate member of a patient, and a proximal location on a bronchoscope or catheter may correspond to a distal location on the elongate member of a patient.

[0025]

[0035] The endoscopic systems described herein include an elongated portion or member, such as a catheter. The terms “elongated member” and “catheter” are used interchangeably throughout this specification unless the context suggests otherwise. The elongated member can be positioned directly within a body lumen or cavity. In some embodiments, the system may further include a support device, such as a robotic manipulator (e.g., a robotic arm), for driving, supporting, positioning, or controlling the movement and / or motion of the elongated member. Alternatively or additionally, the support device may be a handheld or other control device, which may or may not include a robotic system. In some embodiments, the system may further include peripheral devices and subsystems, such as an imaging system, that assist and / or facilitate navigation of the elongated member to a target site within a subject's body.

[0026]

[0036] The endoscopic systems of the present disclosure may combine multiple sensing modalities to provide expanded vision capabilities. In some embodiments, the multimodal sensing system may include at least position sensing (e.g., EM sensor systems, optical shape sensors, accelerometers, gyroscope sensors), direct vision (e.g., cameras), and ultrasound imaging.

[0027]

[0037] In some cases, the endoscope system may implement a position sensing system, such as an electromagnetic (EM) sensor, fiber optic sensor, and / or other sensor, for registering and displaying the medical implement with pre-operatively recorded surgical images, thereby determining the position of the distal portion of the endoscope relative to the patient's body or a global reference frame. The position sensor may be a component of an EM sensor system including one or more conductive coils that can be exposed to an externally generated electromagnetic field. Each coil of the EM sensor system used to implement the position sensor system then generates an induced electrical signal having characteristics that depend on the coil's position and orientation relative to the externally generated electromagnetic field. In some cases, the EM sensor system used to implement the position sensing system may be configured and positioned to measure at least three degrees of freedom, e.g., three position coordinates: X, Y, and Z. Alternatively or additionally, the EM sensor system may be configured and positioned to measure six degrees of freedom, e.g., three position coordinates: X, Y, and Z, and three orientation angles indicating the pitch, yaw, and roll of a fiducial, or five degrees of freedom, e.g., three position coordinates: X, Y, and Z, and two orientation angles indicating the pitch and yaw of a fiducial.

[0028]

[0038] Direct vision may be provided by an imaging device such as a camera. The camera may include imaging optics (e.g., lens elements), an image sensor (e.g., CMOS or CCD), and illumination (e.g., LED or fiber-based light). The imaging device may be located at the distal tip of the catheter or on the elongated member of the endoscope. In some cases, the direct vision system may include an imaging device and an illumination device. In some embodiments, the imaging device may be a video camera. The imaging device may include optics and an image sensor for capturing image data. The image sensor may be configured to generate image data in response to wavelengths of light. Various image sensors for capturing image data may be employed, such as a complementary metal-oxide semiconductor (CMOS) or a charge-coupled device (CCD). The imaging device may be a low-cost camera. In some cases, the image sensor may be provided on a circuit board. The circuit board may be an imaging printed circuit board (PCB). The PCB may include multiple electronic elements for processing the image signal. For example, the circuitry for a CCD sensor may include an A / D converter and amplifiers to amplify and convert the analog signals provided by the CCD sensor and circuit elements to combine or serialize the data for transmission within a minimal number of conductors. Optionally, the image sensor may be integrated with amplifiers and converters to convert the analog signals to digital signals so that a circuit board is not required. In some cases, the output of the image sensor or circuit board may be image data (digital signals) that can be further processed by the camera circuitry or camera processor. In some cases, the image sensor may comprise an array of optical sensors. As described later herein, the imaging device may be located at the distal tip of a catheter, in a separate hybrid probe that is assembled into an endoscope, or a combination of both.

[0029]

[0039] The provided endoscope can use ultrasound to help guide the physician to locations outside the airway. For example, a user can use ultrasound to identify the location of a lesion in real time to guide the endoscope to where a computed tomography (CT) scan (preoperative imaging) revealed the approximate location of a solitary pulmonary nodule. In some embodiments, the ultrasound can be linear endobronchial ultrasound (EBUS), also known as convex probe EBUS, which can image on the side of the endoscopic device. For example, a linear endobronchial ultrasound (EBUS) transducer or vibrating array can be positioned in the distal portion of the endoscope, providing a view parallel to the endoscope shaft. In some cases, the ultrasound can be radial probe EBUS, which provides 360° radial imaging.

[0030]

[0040] Multimodal sensing systems can advantageously improve the vision capabilities of endoscopic devices. For example, EM sensors can provide GPS-like navigation information to the user to navigate to the target site and view anatomical landmarks and features using a direct visualization camera to further confirm location relative to preoperative images (e.g., CT scan 3D models). If a lesion is not visible within the airway while at the target site, ultrasound information can be used to identify the exact location of the lesion on-site and in real time. Ultrasound imaging can be used to visualize the depth (e.g., several millimeters or centimeters) into the tissue next to the ultrasound transducer to determine the exact location of the lesion for purposes of taking a biopsy or delivering a treatment or therapy (e.g., pharmacological, mechanical, or thermal therapy). In some cases, the location of the lesion identified by ultrasound imaging can be used to register the ultrasound location to EM sensor-based 3D location information so that the location of the catheter tip or device can be automatically controlled.

[0031]

[0041] In some embodiments, an ultrasound probe may be removably incorporated into the bronchoscope system to enhance visual guidance to the user. The ultrasound probe may include an ultrasound transducer located at a distal portion of the probe and may be movable along the length of the endoscope.

[0032]

[0042] In some embodiments, the hybrid probe can be assembled into an existing bronchoscope system. The hybrid probe can include at least a camera, a position sensor (e.g., an EM sensor), and an ultrasound transducer to provide multimodal sensing capabilities to the endoscope assembly. The bronchoscope can be an articulating device controlled to navigate a path under guidance provided by the hybrid probe. In other embodiments, the articulating device can include a camera and a position sensor (e.g., an EM sensor), while the hybrid probe can include a position sensor (e.g., an EM sensor) and an ultrasound transducer.

[0033]

[0043] 1 illustrates an example of an assembly of an endoscopic system 100, according to certain preferred embodiments of the present disclosure. The endoscopic system 100 may include an articulating bronchoscope 110 and a hybrid probe 120. The hybrid probe 120 may be removably assembled to the bronchoscope, such as by insertion through a channel of a bronchoscope catheter.

[0034]

[0044] The bronchoscope 110 may include suitable means for deflecting the distal tip 111 of the scope to follow the path of the structure under examination with minimal deflection or frictional forces on the surrounding tissue. For example, control or pulling cables may be implemented within the endoscope body to connect the articulating section proximal to the distal tip 111 to a set of control mechanisms at the proximal end (e.g., handle) of the endoscope or in a robotic support system.

[0035]

[0045] The robotic bronchoscope system 100 can be releasably coupled to an instrument drive. The instrument drive can be mounted on an arm of the robotic support system or any actuation support system. The instrument drive can provide a mechanical and electrical interface to the robotic bronchoscope system 100. The mechanical interface can allow the robotic bronchoscope system 100 to be releasably coupled to the instrument drive. For example, a handle portion of the robotic bronchoscope 110 can be attached to the instrument drive via a quick-attach / release means such as a magnet and a spring-loaded level. In some cases, the robotic bronchoscope 110 can be manually coupled to or released from the instrument drive without the use of tools.

[0036]

[0046] FIG. 8 shows an example of a robotic bronchoscope system supported by a robotic support system. In some cases, the handle portion may electrically communicate with the instrument drive (e.g., instrument drive 820) via an electrical interface (e.g., a printed circuit board), so that image / video data and / or sensor data can be received by a communication module in the instrument drive and transmitted to other external devices / systems. In some cases, the electrical interface may establish electrical communication without cables or wires. For example, the interface may include pins soldered onto an electronic board such as a printed circuit board (PCB). For example, a receptacle connector (e.g., a female connector) may be provided on the instrument drive as a mating interface. This may advantageously allow the endoscope to be quickly plugged into the instrument drive or robotic support without utilizing a special cable. This type of electrical interface may also serve as a mechanical interface, such that both a mechanical and electrical connection is established when the handle portion is plugged into the instrument drive. Alternatively or additionally, the instrument drive may provide only the mechanical interface. The handle portion may be in electrical communication with the modular wireless communication device or any other user device (e.g., a portable / handheld device or controller) for transmitting sensor data and / or receiving control signals.

[0037]

[0047] As shown in FIG. 8 , the robotic bronchoscope 820 can include a handle portion 813 and a flexible elongate member 811. In some embodiments, the flexible elongate member 811 can include a shaft, a steerable tip, and a steerable section. The robotic bronchoscope 820 can be similar to the steerable catheter assembly described in FIG. 1 . The robotic bronchoscope can be a single-use robotic bronchoscope. In some cases, only the catheter can be disposable. In some cases, at least a portion of the catheter can be disposable. In some cases, the entire robotic bronchoscope can be released from the instrument drive mechanism and disposed of. The bronchoscope can include varying levels of stiffness along its shaft to improve functional operation.

[0038]

[0048] The robotic bronchoscope can be releasably coupled to the instrument drive 820. The instrument drive 820 can be attached to an arm of a robotic support system or to any actuation support system, as described elsewhere herein. The instrument drive can provide a mechanical and electrical interface to the robotic bronchoscope 820. The mechanical interface can allow the robotic bronchoscope 820 to be releasably coupled to the instrument drive. For example, a handle portion of the robotic bronchoscope can be attached to the instrument drive via quick installation / release means, such as a magnet and spring-loaded level. In some cases, the robotic bronchoscope can be manually coupled to or released from the instrument drive without the use of tools.

[0039]

[0049] In some cases, a separate instrument drive mechanism may be used to control the movement of the hybrid probe. For example, the proximal portion of the hybrid probe may be coupled to a second instrument drive mechanism to articulate the tip of the hybrid probe. Alternatively or additionally, the roll motion of the hybrid probe may be controlled by a controller operably coupled to the controller of the catheter. This may advantageously provide robotic control of both the hybrid probe and the catheter, thereby enabling coordinated control of the hybrid probe and the catheter with minimal user input.

[0040]

[0050] 9 shows an example of an instrument drive mechanism 920 that provides a mechanical interface to a handle portion 913 of a robotic bronchoscope. As shown in the example, the instrument drive mechanism 920 may include a set of motors that are actuated to rotatably drive a set of puller wires of a catheter. The handle portion 913 of the catheter assembly may be mounted on the instrument drive mechanism such that its pulley assembly is driven by the set of motors. The number of pulleys may vary based on the puller wire configuration. In some cases, one, two, three, four, or more puller wires may be utilized to articulate the catheter.

[0041]

[0051] The handle portion can be designed to allow the robotic bronchoscope to be low-cost and disposable. For example, older manual robotic bronchoscopes may have cables within the proximal end of the bronchoscope handle. The cables often include illumination fibers, camera video cables, and other sensor fibers or cables, such as electromagnetic (EM) sensors or shape-sensing fibers. These composite cables can add cost to the cost of the bronchoscope. The provided robotic bronchoscopes may have an optimized design such that simplified structures and components can be employed while retaining mechanical and electrical functionality. In some cases, the handle portion of the robotic bronchoscope may employ a cable-less design while providing the mechanical / electrical interface to the catheter.

[0042]

[0052] In some cases, the handle portion may be a housing or may include components configured to process image data, provide power, or establish communication with other external devices. In some cases, the communication may be wireless. For example, wireless communication may include Wi-Fi, radio communication, Bluetooth, IR communication, or other types of direct communication. Such wireless communication capabilities enable the robotic bronchoscope to function in a plug-and-play manner and be conveniently disposable after a single use. In some cases, the handle portion may include circuit elements, such as a power supply for powering electronics (e.g., a camera and LED light source) disposed within the robotic bronchoscope or catheter.

[0043]

[0053] The handle section can be designed in conjunction with the catheter to eliminate cables or fibers. For example, the catheter section can be designed with a working channel that allows instruments to pass through a robotic bronchoscope, a vision channel that allows hybrid probes to pass through, and low-cost electronics such as a chip-on-tip camera, an illumination source such as a light-emitting diode (LED), and an EM sensor located in optimal locations according to the mechanical structure of the catheter. This can enable a simplified design of the handle section. For example, by using LEDs for illumination, the termination of the handle section can be based solely on electrical soldering or wire crimping. For example, the handle section can include a proximal plate on which the camera cable, LED cable, and EM sensor cable terminate, which connects to an interface in the handle section and establishes an electrical connection to the instrument drive mechanism. As mentioned above, the instrument drive mechanism is attached to the robot arm (robot support system) and provides a mechanical and electrical interface to the handle section. This advantageously improves assembly and packaging efficiency and simplifies the manufacturing process and costs. In some cases, the handle section can be disposed of together with the catheter after a single use.

[0044]

[0054] Referring again to FIG. 1, in some cases, the distal tip of the bronchoscope may include a position sensor, such as EM sensor 113, for tracking the location of the distal tip of the bronchoscope relative to a global reference frame or the patient's anatomy.

[0045]

[0055] The bronchoscope catheter may include a lumen sized to receive the hybrid probe, a lumen for receiving an instrument, or working channel 130. Various instruments are insertable through the lumen, such as biopsy needles, graspers, scissors, baskets, snares, curettes, laser fibers, sutures, balloons, dividers, and various implant or stent delivery devices. In some cases, the EM sensor 113 that tracks the location of the distal tip may be registered with ultrasound imaging (provided by the hybrid probe) so that the distal tip of the catheter and / or instrument carried within the working channel 130 can be located with respect to the location of a lesion identified by ultrasound. In some cases, the movement of the instrument may be captured within the linear EBUS view 122.

[0046]

[0056] The hybrid probe 120 may include at least a position sensor, such as an EM sensor 123 and an ultrasound transducer 121. The transducer 121 may include an array of one or more transducers to perform real-time ultrasound imaging. In some cases, the transducer may include a convex ultrasound transducer located at the tip of the probe, enabling linear scanning parallel to the insertion direction of the bronchoscope to evaluate structures around the central airway (e.g., a linear EBUS view 122). The linear EBUS view is parallel to the insertion direction of the bronchoscope. This can be done by direct contact of the hybrid probe with the airway wall or via a water-inflated distal balloon.

[0047]

[0057] The hybrid probe can be connected to an ultrasound scanner with a color Doppler system to better distinguish between solid and vascular structures. In one example, the ultrasound transducer can include a 7.5 MHz linear curved array ultrasound transducer located at the distal portion of the probe to provide imaging in B-mode and / or color Doppler mode. The ultrasound imaging system can provide ultrasound views 122 by scanning a field of view at a specific angle from the longitudinal axis or oblique forward degrees of the camera view. By way of non-limiting example, the ultrasound imaging system can provide a scan range defined by a field of view within a range of 30° to 80°, a direction of view within a range of 25° to 90° oblique forward, and a depth of field within a range of 2 to 80 mm.

[0048]

[0058] The hybrid probe 120 may include a position sensor, such as an EM sensor 123. The EM sensor may be positioned at a distal portion of the hybrid probe to track the real-time location of the probe's distal location relative to a global reference frame. In some cases, the EM sensor may be optional, but the location of the hybrid probe's distal tip may be obtained based on EM sensor data provided by an EM sensor 113 located on the bronchoscope and the relative position of the hybrid probe with respect to the tip of the bronchoscope. The EM sensor 113 located on the distal tip of the catheter and the EM sensor 123 located on the hybrid probe may be used to robotically control the location / motion of the hybrid probe and the bronchoscope. For example, control commands may be generated based on position information (e.g., EM sensor data captured by the EM sensor 113 and the EM sensor 123) to adjust the movement of the catheter 110 and the hybrid probe 120.

[0049]

[0059] In some cases, the hybrid probe 120 may include an imaging device such as a camera 124. The camera 124 may be located at the tip of the hybrid probe to provide a forward video / camera view 125 parallel to the longitudinal axis of the probe. Alternatively, the camera 124 may be integrated into the distal tip 111 of the bronchoscope.

[0050]

[0060] In some embodiments, the hybrid probe 120 may include an illumination device 126 located at the distal end of the probe. The illumination device may comprise one or more light sources positioned at the distal tip of the hybrid probe 120. The illumination device may be located at the distal end of the hybrid probe. Alternatively or additionally, the illumination device may be located at the distal end of the articulating bronchoscope 110. The light source may be a light-emitting diode (LED), organic LED (OLED), quantum dot, or any other suitable light source. In some cases, the light source may be miniaturized LED or dual-tone flash LED lighting for a compact design. In some cases, the illumination device may be fiber-based lighting, which may include a single fiber or fiber bundle coupled to an LED or laser.

[0051]

[0061] In some cases, one or more LEDs may each be connected to a power wire that may reach the proximal handle of the hybrid probe. In some embodiments, the LEDs may be soldered to separate power wires that are then bundled together to form a single stranded wire. In some embodiments, the LEDs may be soldered to puller wires that provide power. In other embodiments, the LEDs may be crimped or directly connected to a single pair of power wires. In some cases, a protective layer, such as a thin layer of biocompatible adhesive, may be applied to the front of the LEDs to provide protection while still allowing light to be emitted.

[0052]

[0062] The imaging device 124, the illumination device, the EM sensor 123, and the ultrasound transducer may be integrated into the hybrid probe. For example, the distal portion of the hybrid probe may have an appropriate structure that matches at least the dimensions of the upper electronics. In some cases, the distal tip of the hybrid probe may have dimensions that allow one or more electronic components to be integrated into the distal tip. For example, the imaging device 124 may be integrated into a cavity in the distal tip of the hybrid probe. The cavity may be integrally formed with the distal portion of the hybrid probe and may have dimensions that match the length / width of the camera so that the camera does not move relative to the hybrid probe.

[0053]

[0063] In some cases, the EM sensor 123 may be disposed in the distal portion of the hybrid probe, positioned adjacent to or behind the illumination light source (e.g., an LED) in a stereoscopic configuration. FIG. 10 shows an example of the distal portion of a hybrid probe with an integrated imaging and illumination device. Note that the hybrid probe distal tip design is also applicable to the distal tip of a catheter with integrated vision described in FIG. 4. A camera may be located in the distal portion. The distal tip may have structures for receiving a camera, an illumination device, and / or a location sensor. For example, the camera may be integrated into a cavity 1010 at the distal tip of the catheter. The cavity 1010 may be integrally formed with the distal portion of the cavity and may have dimensions matching the length / width of the camera so that the camera does not move relative to the catheter. In some cases, the distal portion may include a structure 1030 having dimensions matching the dimensions of a miniature LED light source. As shown in the illustrated example, two cavities 1030 may be integrally formed with the distal portion for receiving two LED light sources. Any number of light sources may be included. The internal structure of the distal portion may be designed to fit any number of light sources.

[0054]

[0064] In some cases, each of the LEDs may be connected to a power wire that can reach the proximal end of the hybrid probe or bronchoscope (the integrated vision embodiment described in FIG. 4). In some embodiments, the LEDs may be soldered to separate power wires that are then bundled together to form a single stranded wire. In some embodiments, the LEDs may be soldered to puller wires that provide power. In other embodiments, the LEDs may be crimped or directly connected to a single pair of power wires. In some cases, a protective layer, such as a thin layer of biocompatible adhesive, may be applied to the front of the LEDs to provide protection while still allowing light to be emitted. In some cases, an additional cover 1031 may be placed on the forward end surface of the distal tip, providing sufficient room for precise positioning of the LEDs as well as the adhesive. The cover 1031 may be made of a transparent material that matches the refractive index of the adhesive so that the illumination light is not obstructed.

[0055]

[0065] An electromagnetic coil located at the distal tip can be used with an electromagnetic tracking system to detect the position and orientation of the hybrid probe's distal tip while it is disposed within the anatomical system. In some embodiments, the coil can be angled to provide the ability to measure susceptibility to electromagnetic fields along different axes, a total of six degrees of freedom: three positions and three angles. During navigation, such as when the hybrid probe is retracted inside the catheter, an EM field generator positioned next to, under, or on the patient's torso can identify the location of the EM sensor, thereby tracking the location of the catheter tip in real time. During a procedure, such as when the hybrid probe is extended distally of the catheter, the EM sensor can track the location of the hybrid probe's tip in real time.

[0056]

[0066] Referring again to FIG. 1 , the provided hybrid probe may have a compact configuration of electronic elements disposed in the distal portion. For example, one or more electronic components may be bundled to provide a compact design. FIG. 11 shows an example of a compact configuration of electronic elements located in the distal portion. In some cases, the illumination source 1120 and one or more position sensors 1110 may be combined into a single bundle. In some cases, the cable connected to the ultrasound transducer 1130 may also be bundled with the cables of other electronic devices to further reduce the size of the hybrid probe.

[0057]

[0067] Referring again to FIG. 1 , power to the camera 124 may be provided by a wired cable. In some cases, the cable wires may be in a wire bundle that provides power to the camera and lighting elements or other circuit elements at the distal tip of the hybrid probe. The camera and / or light source may be powered from a power source disposed in the handle portion of the hybrid probe via wire, copper wire, or any other suitable means passing through the length of the hybrid probe. In some cases, real-time images or videos of the tissue or organ may be transmitted wirelessly to an external user interface or display. The wireless communication may be WiFi, Bluetooth, RF communication, or other form of communication. In some cases, images or videos captured by the camera may be broadcast to multiple devices or systems. In some cases, image and / or video data from the camera may be transmitted down the length of the hybrid probe via wire, copper wire, or any other suitable means to a processor located in the handle portion. The image or video data may be transmitted to an external device / system via wireless communication components in the handle portion. In some cases, the system may be designed so that the wires are not visible or exposed to the operator.

[0058]

[0068] As previously mentioned, the hybrid probe is movable relative to the bronchoscope. The hybrid probe may have translational movement along the longitudinal axis of the lumen and rotational movement relative to the bronchoscope. For example, the hybrid probe may be extendable relative to the distal tip of the bronchoscope. For example, the hybrid probe may be slidable along the lumen of the catheter. The tip of the hybrid probe may extend out along the longitudinal axis of the distal tip of the bronchoscope when hybrid vision is needed. Alternatively or additionally, the hybrid probe may be articulated independently of the bronchoscope. For example, the hybrid probe may have a bending section that is articulatable independent of bronchoscope movement.

[0059]

[0069] As previously mentioned, an imaging device located on the hybrid probe can provide a forward-looking view aligned with the forward direction of the hybrid probe. Providing an imaging device on the distal tip of the hybrid probe instead of the catheter advantageously allows for a clear near-field view of the tissue or organ without being obstructed by the movement of the hybrid probe or the tool (e.g., needle). Additionally, providing an imaging device on the hybrid probe allows for an additional degree of freedom for the camera view to separate the camera view from the working area of ​​the tool. The camera view provided by the hybrid probe can be controlled by increasing its flexibility (e.g., the attitude or orientation of the imaging device can be controlled by controlling the articulation of the hybrid probe relative to the catheter) to better coordinate with the movement of the tool.

[0060]

[0070] In some cases, an additional imaging device may be provided at the distal tip of the catheter 111. This advantageously allows different camera views to be provided simultaneously by the hybrid probe and the imaging device located on the catheter. For example, when the hybrid probe is articulated with respect to the catheter, the camera view of the imaging device located on the hybrid probe may differ from the camera view of the imaging device located on the catheter.

[0061]

[0071] In some cases, the catheter / bronchoscope and hybrid probe may be robotically controlled to adjust the camera view and tool movement of the imaging device. For example, a catheter may be advanced toward a target site under the robotic control of a robotic bronchoscope system. Once at the target site, the hybrid probe may be robotically controlled (e.g., extended, retracted, articulated, rotated / rolled with respect to the catheter) to provide a desired ultrasound view of the lesion and / or needle camera view, while the distal tip of the catheter may be locked to provide a forward-looking camera view. In some cases, the hybrid probe may automatically adjust the view based on the movement of the tool (e.g., needle).

[0062]

[0072] FIG. 2 shows an example 200 of a hybrid probe 213 that can be extended distally beyond the distal tip 211 of a bronchoscope. The bronchoscope can be the same as the bronchoscope described in FIG. 1. For example, the bronchoscope can include at least a working channel 215 for receiving instruments and EM sensors located at the distal tip. In some cases, the hybrid probe can be flush with the distal end surface 217 of the catheter during navigation to a target site where only direct vision (e.g., a camera view) is required. In some cases, when ultrasound imaging is desired, the hybrid probe can extend beyond the tip of the catheter to expose the ultrasound transducer 219. The hybrid probe and bronchoscope can include reversible interlock features that lock the position of the hybrid probe relative to the bronchoscope to prevent axial and / or rotational movement. In some cases, the hybrid probe can be rotatable relative to the bronchoscope to identify a lesion site when the hybrid probe is operating to provide ultrasound imaging. For example, when the hybrid probe is extended to a desired length and / or rotated to a desired angle, the interlock feature may lock the location / orientation of the hybrid probe relative to the bronchoscope.

[0063]

[0073] 3 shows an example of a hybrid probe 300 that rotates relative to a distal portion 310 of a catheter. The ultrasound transducer 301 can be rotated to any desired location to provide an image around the tip of the probe. As shown in this example, the hybrid probe 300 is extended to a desired extent beyond the tip of the catheter, and the ultrasound transducer 301 can be rotated to different angular locations for imaging. In some cases, once the hybrid probe is positioned at a desired angular location and / or length, an interlocking feature can lock the location of the hybrid probe relative to the bronchoscope.

[0064]

[0074] The hybrid probe can be rotated independently of the catheter, allowing any point surrounding the distal portion of the hybrid probe to be visualized by rotation of the hybrid probe. The rotational movement of the hybrid probe can be controlled robotically or manually. The rotational manipulation allows the user to reposition the linear ultrasound field of view throughout the circumference of the airway. For example, the location of a lesion can be identified with the assistance of EBUS and by rotation of the hybrid probe, and once the location of the lesion is identified, the catheter can be repositioned (e.g., inserted or rotated) accordingly so that a biopsy instrument can be introduced and advanced directly out of the working channel and into the location of the lesion.

[0065]

[0075] In some embodiments, an ultrasound transducer and camera may be integrated into a bronchoscope as a single device. Figure 4 shows an example of an endoscope 400 with integrated hybrid vision. As shown in this example, the distal tip of the endoscope may include an integrated, laterally-oriented linear ultrasound probe 401, along with an integrated forward-facing camera 405 for direct visualization and an illumination source. One or more position sensors, such as an EM sensor 403, may also be integrated into the distal tip.

[0066]

[0076] Imaging devices, illumination devices, EM sensors, and ultrasound transducers may be integrated into the catheter. For example, the distal portion of the catheter may have an appropriate structure that matches the dimensions of at least the electronic devices. In some cases, the distal tip of the catheter may have dimensions that allow one or more electronic components to be integrated into the catheter. For example, the outer diameter of the distal tip may be approximately 4 to 4.4 millimeters (mm), and the diameter of the working channel may be approximately 2 mm, allowing one or more electronic components to be incorporated within the distal tip. However, it should be noted that, depending on various applications, the outer diameter may be within any range, such as less than 4 mm or greater than 4.4 mm, and the diameter of the working channel may be within any range, depending on the dimensions of the tool or the particular application.

[0067]

[0077] The EM sensor, camera, and ultrasound transducer can be the same as those described elsewhere herein. For example, the camera can be a tip camera, and the illumination source can be a light-emitting diode (LED), organic LED (OLED), quantum dot, or any other suitable light source. In some cases, the light source can be a miniaturized LED or dual-tone flash LED lighting for a compact design. In some cases, the aforementioned electronics can be integrated into the tip of the catheter.

[0068]

[0078] The distal bronchoscope may include a working channel 413 with a lateral exit / port 414. In some cases, the lateral exit 414 may be located in the articulating section 411 of the catheter. The catheter may include a shaft 410, an articulating (bending) section 411, and a movable distal portion 412, with the articulating (bending) section 411 connecting the movable distal portion to the shaft 410. For example, the bending section 411 may be connected at a first end to a distal tip portion and at a second end to a shaft portion, with the bending section being articulated by one or more puller wires. In some cases, the bending section may be fabricated separately as a modular component and assembled onto the shaft. In some cases, the bending section may further incorporate minimal features, thereby reducing cost and increasing reliability. For example, the bending section may incorporate a cut pattern that allows for a greater degree of tube deflection to achieve a desired tip displacement relative to the shaft. In some cases, the bending section may be comprised of stainless steel ribbon. The bending section may be formed of other suitable structures or materials to achieve a predetermined bending stiffness while maintaining a desired axial and torsional stiffness with low articulation forces, for example, the bending section may comprise a braided structure for torsional stability.

[0069]

[0079] A lateral port 414 is located in the bend section 411. The distal end of the instrument can extend from a location within the elongate flexible shaft along a path and through the lateral exit to an extended location outside the catheter at an angle θ relative to the longitudinal axis of the catheter tip, thereby allowing the instrument to extend out of the lateral port 414 and into the EBUS view 417 (to be captured by ultrasound) even without articulation of the instrument.

[0070]

[0080] The working channel lumen has a port located in the bent section, allowing the instrument to extend out of the port along a trajectory that intersects the EBUS view. For example, as shown in FIG. 4 , the working channel exit trajectory 416 intersects the linear endobronchial ultrasound (EBUS) field of view 417 or an image captured by ultrasound. The biopsy device 415 (e.g., forceps, needle, brush) may be extendable at an angle of at least 30 degrees relative to the longitudinal axis along a path from a position within the lateral wall through a lateral exit / port to a position outside the lateral wall. The path of the biopsy device 415 may pass through / intersect the EBUS field of view (e.g., ultrasound image) so that at least a tip portion of the instrument is visible in the ultrasound image. In some cases, the path of the biopsy device may be calibrated to the location of an electromagnetic localization (EM) sensor 403 positioned at the distal end portion of the elongated flexible shaft 410 and displayed by a surgical instrument navigation system.

[0071]

[0081] The steerable catheter can be rotated, allowing any point surrounding the distal end of the catheter to be visualized by rotating the catheter. The rotational movement of the catheter can be robotically controlled. The rotational maneuver allows the user to reposition the linear ultrasound field of view throughout the circumference of the airway. For example, a lesion location can be identified with the assistance of EBUS and by rotating the catheter, and once the lesion location is identified, a biopsy instrument can be introduced and advanced out of the working channel and into the lesion location.

[0072]

[0082] In some embodiments, a hybrid vision assembly may comprise a bronchoscope with integrated direct vision and location sensing and a hybrid probe with a balloon. The distal end of the bronchoscope may include an integrated forward-facing camera and lighting for direct visualization, and an integrated EM sensor (e.g., at least three degrees of freedom) to generate 3D localization information.

[0073]

[0083] In some cases, the hybrid probe may include at least an ultrasound transducer and an EM sensor located at a distal portion of the hybrid probe and covered by one or more balloons. In some cases, the hybrid probe may include a guidewire with an expandable outer diameter feature at its tip where the EBUS transducer and EM sensor are located. FIG. 5 shows an example of a hybrid probe with an inflatable tip 503. As shown in FIG. 5, the working channel exit trajectory 508 intersects with a linear endobronchial ultrasound (EBUS) view 509 of an ultrasound image. The hybrid probe is inserted through the working channel of a catheter / bronchoscope 505 and may extend beyond the catheter to aid in navigation of airways 510 within the lungs. In some cases, the tip of the hybrid probe may extend beyond the tip of the catheter into the desired airway 510, and the catheter may then slide over the guidewire / probe to reach the desired location. The inflatable tip can be implemented using various suitable methods, such as an inflatable balloon. A balloon 503 may be positioned at or near the distal end of the probe and may cover the linear EBUS transducer 507 and the EM sensor 501. The balloon may be connected to a balloon inflation source via the working channel or may be pumped for inflation or deflation of the balloon.

[0074]

[0084] In some cases, the balloon may also create a seal across one of the passageways at the seal point before the passageway distal to the seal point contracts. One or more balloons may be expanded and / or contracted to create a temporary closure in the passageway by injection of air, saline, and / or some other gas or fluid. In some examples, the shape of the balloon when expanded is malleable, allowing the balloon to conform to the shape of the passageway and expand around the tip of the one or more sensors and hybrid probe.

[0075]

[0085] The EM sensors and ultrasound transducers may be the same as those described elsewhere herein, for example, the EM sensor located at the tip of the catheter 505 and the EM sensor covered by the balloon may be a 6DOF EM sensor.

[0076]

[0086] FIG. 6 shows an example of a hybrid probe 603 with a balloon tip. For example, the hybrid probe 603 can provide an ultrasound view of the lesion site along with 3D localization information from an EM sensor. The balloon 601 can cover the EM sensor and ultrasound transducer 605. A hybrid probe 607 is shown with a deflated balloon. In some cases, the EM sensor information can be registered and correlated with the ultrasound image. The hybrid probe can be removably coupled to the catheter. The hybrid probe can be insertable and retractable along the longitudinal axis of the catheter and movable relative to the catheter, such as being rotatable to capture various ultrasound views and EM data points. Once the lesion site is identified and the 3D location of the lesion is determined, the physician can manipulate the position of the bronchoscope to align the trajectory of the biopsy tool with the location of the lesion. The position or trajectory of the biopsy tool can be determined based, at least in part, on location data provided by an EM sensor located at the distal tip of the catheter and a known model of the catheter and / or device.

[0077]

[0087] The catheter, bronchoscope, and / or hybrid probe can be robotically controlled. For example, the catheter can be advanced toward the target site under the robotic control of a robotic bronchoscope system. The catheter can be guided or advanced toward the target site in a manual, autonomous, or semi-autonomous manner. In another example, the movement of the hybrid probe can be automatically controlled, thereby automatically controlling the insertion, retraction, and rotational movements for capturing ultrasound images. Alternatively, the bronchoscope and / or hybrid probe can be controlled via a handheld device.

[0078] User Interface

[0088] In some embodiments, real-time imaging of the target site (e.g., including the lesion) provided by the multimodal sensing system can be displayed on a user interface. Figure 7 shows an example of a user interface displaying an EBUS view, a direct video / camera view, and a virtual airway model based on preoperative images (e.g., preoperative CT images) for real-time accurate lesion location tracking.

[0079]

[0089] In some cases, real-time lesion location can be identified from ultrasound views. The lesion location can be registered with the coordinate frame of the bronchoscope system using EM sensor data. In some embodiments, the lesion location can be segmented in image data captured by the linear EBUS probe with the aid of a signal processing unit. In some cases, one or more processors of the signal processing unit can be configured to overlay the treatment location (e.g., lesion) on the real-time ultrasound image / video. In some cases, both the segmented lesion image and an optimal path for navigation of the elongated member to reach the lesion can be overlaid on the real-time ultrasound image. This allows the operator or user to visualize the exact location of the lesion as well as the path of planned bronchoscope movement.

[0080]

[0090] In some embodiments, the bronchoscope system may include a navigation and localization subsystem configured to construct a virtual airway model based on preoperative images (e.g., preoperative CT images). The navigation and localization subsystem may be configured to identify an approximate segmented location of a lesion in the 3D-rendered airway model based on the location of the lesion, and the navigation and localization subsystem may generate an optimal route from the main bronchus to the lesion with a recommended approach angle toward the lesion to perform a surgical procedure (e.g., biopsy). For example, the processing unit may be configured to generate an augmentation layer containing augmentation information such as a treatment location or a lesion location. In some cases, the augmentation layer may also include a graphical marker indicating the route to the target site. The augmentation layer may be a substantially transparent image layer containing one or more graphical elements (e.g., a box, an arrow, etc.). The augmentation layer may be superimposed on an optical view of an optical image or video stream captured by a fluoroscopic (tomosynthesis) imaging system and / or displayed on a display device. The transparency of the augmentation layer allows a user to view the optical image with the graphical elements superimposed. In some cases, both the segmented lesion image and the optimal path for navigation of the elongated member to reach the lesion may be overlaid on the virtual airway model or pre-operative image. This may allow the surgeon or user to visualize the approximate location of the lesion as well as the planned path of bronchoscope movement. In some cases, segmented and reconstructed images (e.g., CT images described elsewhere) provided prior to operation of the systems described herein may be overlaid on the real-time image.

[0081]

[0091] In a registration step prior to driving the bronchoscope to the target site, the system can align a rendered virtual view of the airways with the patient's airways. Image registration can consist of a single registration step or a combination of a single registration step and real-time sensory updates to the registration information. Once registered, all airways can be aligned with the pre-procedure rendered airways. During driving of the robotic bronchoscope toward the target site, the location of the bronchoscope within the airways can be tracked and displayed. In some cases, the location of the bronchoscope relative to the airways can be tracked using a positioning sensor. Other types of sensors (e.g., cameras) can be used instead of or in conjunction with a positioning sensor using sensor fusion techniques. A positioning sensor, such as an electromagnetic (EM) sensor, can be incorporated into the distal tip of the catheter, and an EM field generator can be positioned next to the patient's torso during the procedure. The EM field generator can identify the EM sensor location in 3D space or, alternatively, the EM sensor's location and orientation in 5D or 6D space. This can provide a visual guide to the surgeon as they drive the bronchoscope toward the target site.

[0082]

[0092] During operation, the location of the lesion can be updated and tracked in real time based on the ultrasound views. In some cases, the location of the lesion can be marked on the ultrasound views, and the distal tip of the bronchoscope can be articulated, rotated, or translated to align the instrument trajectory with the location of the lesion.

[0083]

[0093] In some embodiments, the processor may use one or more real-time locations of the lesion, the bronchoscope, and the instrument to calculate one or more possible geometries / configurations, as shown in FIGS. 4 and 5 . For example, the system may calculate the appropriate movement of the hybrid probe to establish a desired configuration (e.g., the trajectory, instrument angle, and EBUS view location in FIG. 5 ) so that the instrument can access the lesion under direct ultrasound imaging. Furthermore, in some embodiments, the system may partially or fully control the hybrid probe, bronchoscope, and instrument to establish the optimal geometry / configuration. For example, once the system knows and can track the locations of all of these elements, it may generate a plan to be executed by the robotic system to move the instrument, hybrid probe, and bronchoscope into the desired configuration relative to the lesion site. In some cases, guidance may be displayed to the user for manipulating one or more of the instrument, hybrid probe, and bronchoscope. For example, the user may be provided with guidance such as "stop the bronchoscope here," "move the hybrid probe to this location," or "insert the instrument now" to reach the desired configuration. In some cases, the configuration may be reached in a semi-autonomous manner. For example, a user may be permitted to activate / trigger or stop motion while the robotic system automatically controls the motion of the hybrid probe, instrument, and / or bronchoscope (e.g., the user may hold an activation trigger, and when the trigger is held, the robotic system moves the hybrid probe, instrument, and / or bronchoscope). In some cases, the robotic system may stabilize the desired geometry / configuration by automatically tracking the patient's respiratory motion (e.g., respiratory motion compensation).

[0084]

[0094] FIG. 7 shows an example of a user interface for visualizing a real-time ultrasound image 705, a virtual airway model 709 with an EM-tracked catheter tip location 701, and a direct camera view 711. In some cases, the virtual airway 709 is superimposed with an optimal path 703, the catheter tip location 701, and a solitary pulmonary nodule (revealed by a CT scan). In this example, the catheter tip location is displayed in real time with respect to the virtual airway model 709, thereby providing visual guidance. As shown in the example of FIG. 7, the optimal path 703 can be displayed and superimposed on the virtual airway model during navigation of the robotic bronchoscope. The virtual airway model can be constructed based on real-time fluoroscopic images / videos (and imaging system location data). The user can also be presented with a camera view or images / videos 711 captured by the bronchoscope and an ultrasound view 705 showing the exact lesion location in real time.

[0085]

[0095] While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. It is understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. The following claims define the scope of the invention, and it is intended that methods and structures within the scope of these claims and their equivalents be covered thereby.

Claims

1. an articulated elongate member including a proximal end and a distal end, wherein a first position sensor is located at the distal end of the articulated elongate member; a multimodal sensing probe removably coupled to the articulating elongate member, the multimodal sensing probe comprising an ultrasound transducer and a camera located at a distal portion of the multimodal sensing probe; A hybrid vision device comprising:

2. The hybrid vision device of claim 1 , wherein the multi-modal sensing probe is inserted through a first lumen of the articulating elongate member.

3. The hybrid vision device of claim 1 , wherein the multi-modal sensing probe is rotatable and extendable relative to the articulating elongate member.

4. The hybrid vision device of claim 1 , wherein the multi-modal sensing probe is articulatable to the articulating elongate member.

5. 10. The hybrid vision device of claim 1, wherein the multimodal sensing probe further comprises a second position sensor positioned at the distal portion of the multimodal sensing probe for tracking a location of the distal portion of the multimodal sensing probe.

6. The hybrid vision device of claim 5 , wherein the second position sensor, the camera, and the illumination device are integrated into the distal portion of the multi-modal sensing probe.

7. The hybrid vision device of claim 6 , wherein the second position sensor, the camera, and the illumination device are arranged in a compact configuration.

8. 6. The hybrid vision device of claim 5, wherein the articulated elongate member and the multi-modal sensing probe are robotically controlled based at least in part on the sensor data captured by the first position sensor and the second position sensor.

9. The hybrid vision device of claim 1 , wherein the ultrasound transducer is an array of linear endobronchial ultrasound (EBUS) transducers.

10. the camera provides a real-time forward view; The hybrid vision device of claim 1 , wherein the ultrasound transducer provides a real-time lateral view.

11. The hybrid vision device of claim 10 , wherein the articulating elongate member comprises a second lumen for receiving an instrument.

12. The hybrid vision device of claim 11 , wherein the equipment movement is captured by the real-time lateral view.

13. The hybrid vision device of claim 1 , wherein the articulated elongate member further comprises an imaging device located at the distal end of the articulated elongate member.

14. The hybrid vision device of claim 1 , wherein the multi-modal sensing probe comprises an expandable tip.

15. an articulated elongate member having a distal tip portion and a bent section; an ultrasound transducer located at the distal tip portion for providing ultrasound images; a channel configured to receive an instrument, the lumen having a port located in the bent section that allows the instrument to extend out of the port along a trajectory that intersects the ultrasound image; A hybrid vision device comprising:

16. The hybrid vision device of claim 15 , wherein the articulated elongate member includes a position sensor located at the distal tip portion.

17. The hybrid vision device of claim 16 , wherein the position sensor is incorporated into the distal tip portion for tracking the location of the distal tip portion.

18. The hybrid vision device of claim 15 , wherein the articulating elongate member includes a camera integrated into the distal tip portion.

19. The hybrid vision device of claim 18 , wherein the camera provides a real-time forward view.

20. 16. The hybrid vision device of claim 15, wherein the ultrasound transducer is an array of linear endobronchial ultrasound (EBUS) transducers.

Images