Systems and methods for responsive insertion and withdrawal of robotic endoscopes

Abstract

A method is provided for controlling a tip speed of an articulating flexible endoscope that includes generating commands to move a tip of an elongated member of the articulating flexible endoscope at a predicted velocity, receiving sensor data acquired by a sensor disposed at a distal tip portion of the elongated member to calculate the tip speed, calculating a difference between the predicted speed and the tip speed, and controlling the tip speed based on the difference.

Description

[Technical field]

[0001] reference

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 324,746, filed March 29, 2022, and U.S. Provisional Patent Application No. 63 / 480,502, filed January 18, 2023, each of which is incorporated by reference in its entirety into this specification. [Background technology]

[0002] background Endoscopy uses an endoscope to examine the inside of hollow organs or body cavities. Unlike many other medical imaging techniques, the endoscope is inserted directly into the organ. Flexible endoscopes, which can provide intuitive navigation and control, are useful for the diagnosis and treatment of diseases accessible through any natural orifice in the body. Depending on the clinical indication, endoscopes can be classified as bronchoscopes, ureteroscopes, colonoscopes, gastroscopes, ENT endoscopes, and various others. For example, flexible bronchoscopes can be used in the diagnosis and / or surgical treatment of lung cancer. However, one challenge in bronchoscopy is reaching the upper lobes of the lungs while advancing through the airways. In another example, flexible endoscopes have been used to examine and treat disorders of the gastrointestinal (GI) tract without the need to create an opening in the patient's body. The endoscope is introduced into the upper or lower GI tract through the mouth or anus, respectively. A miniature camera at the distal end captures images of the GI tract wall that aids clinicians in diagnosing GI diseases. Minor surgical procedures (such as polypectomy and biopsy) can be performed by introducing flexible instruments through the working channel to reach the site of interest at the distal end.

[0003]

[0003] Endoscopes are traditionally made to be reusable and may require extensive cleaning, disinfection and / or sterilization after each procedure. In most cases, cleaning, disinfection and sterilization may be harsh processes to kill pathogens and / or bacteria. Such procedures may also be harsh on the endoscope itself. Thus, the design of such reusable endoscopes may often be complex, especially to ensure that the endoscope can withstand such harsh cleaning, disinfection and sterilization protocols. Periodic maintenance and repairs to such reusable endoscopes are often required.

[0004]

[0004] Low-cost, disposable medical devices designated for single use are becoming popular due to instruments that are difficult to clean properly. Single-use disposable devices can be packaged in sterilization wrap to avoid the risk of pathogen cross-contamination, such as HIV, hepatitis, and other pathogens. Hospitals generally welcome the convenience of single-use disposable products because they eliminate the need to worry about product life, overuse, breakage, failure, and sterilization. Conventional endoscopes often include a handle that the operator uses to operate the endoscope. For single-use endoscopes, the handle typically houses a camera, expensive electronics, and mechanical structures at the proximal end to transmit video and allow the user to operate the endoscope through a user interface. This can lead to high costs for the handle of a single-use endoscope.

[0005]

[0005] Continuum robots and endoscopes are usually long and flexible. The shaft of the endoscope may have problems with buckling or kinking when inserting the device into the anatomical structure. Passive deformation of the endoscope shaft may be the result of insertion forces as well as contact with the anatomical structure where deformation is difficult to model. Prolapse or kinking may result in potential damage as it may expose sharp edges of the kinked elongated device and complicate the surgical procedure. Furthermore, a bent or kinked elongated device may cause the system to lose control of the device's position / shape, which may prevent the device from passing. Summary of the Invention [Problem to be solved by the invention]

[0006]

[0006] The present disclosure recognizes the need for a robotic endoscope that allows for performing surgical or diagnostic procedures with improved performance and cost efficiency. The present disclosure also recognizes devices and systems including endoscopes that may be disposable and may not require extensive cleaning procedures. The present disclosure provides low-cost, single-use, articulatable endoscopes for diagnosis and treatment in a variety of applications, such as bronchoscopy, urology, gynecology, arthroscopy, orthopedics, ENT, gastrointestinal endoscopy, neurosurgery, colonoscopy, and various others. In some embodiments, the present disclosure provides a single-use, disposable, robotically controlled bronchoscope to be used with a robotic system to enable diagnostic evaluation of lesions anywhere in the pulmonary anatomy. It should be noted that the provided endoscopic systems may be used in a variety of minimally invasive surgical, therapeutic or diagnostic procedures involving various types of tissue, including heart, bladder and lung tissue, and in other anatomical regions of a patient's body, such as the digestive system, including but not limited to the esophagus, liver, stomach, colon, urinary tract, or the respiratory system, including but not limited to the bronchi, lungs and various others. [Means for solving the problem]

[0007]

[0007] In one aspect of the present disclosure, a method is provided for controlling a tip speed of an articulating flexible endoscope, the method including generating commands to move a tip of an elongated member of the articulating flexible endoscope at an expected speed, receiving sensor data acquired by a sensor disposed at a distal tip portion of the elongated member to calculate the tip speed, calculating a difference between the expected speed and the tip speed, and controlling the tip speed based on the difference.

[0008] In one aspect, a method is provided for controlling motion of a tip of an articulating flexible endoscope, the method including generating commands to drive an elongated member of the articulating flexible endoscope along an anatomical path via an instrument drive mechanism (IDM), receiving sensor data acquired by a position sensor disposed at a distal tip portion of the elongated member, setting the motion of the distal tip to zero upon determining that the distal tip portion is at a preselected position within the anatomical path and calculating the motion of the distal tip portion within a time window, calculating a difference between the motion of the distal tip portion and the motion of the IDM within the same time window, and detecting a buckling event by comparing the difference to a threshold.

[0009] In some embodiments, the preselected location is a main carina. In some embodiments, the method further includes determining that the distal tip portion is at the preselected location based at least in part on the sensor data and the 3D model of the anatomical path. Optionally, the location sensor includes an electromagnetic sensor.

[0010]

[0010] In some embodiments, the method further includes determining that the distal tip portion is at a preselected position based at least in part on image data acquired by a camera located at the distal tip portion. In some embodiments, the threshold is dynamically determined based on a target anatomical region toward which the articulating flexible endoscope is moving. In some embodiments, the threshold is a function of the tortuosity of the anatomical path.

[0011] In some embodiments, the size of the time window is between 4 seconds and 8 seconds. Optionally, the size of the time window is determined based on empirical data. In some embodiments, the movement of the distal tip portion within the time window is an accumulation of the distance traveled in each time step.

[0012] In some embodiments, the method further includes setting an insertion force applied by the IDM to zero when the distal tip portion is determined to be at a preselected location within the anatomical pathway and comparing the insertion force to a force threshold. In some embodiments, the method further includes generating and displaying a warning message on a user interface when the insertion force is determined to exceed the force threshold.

[0013]

[0013] In some embodiments, the method further includes controlling a velocity of the distal tip portion of the elongate member based on a difference between the expected velocity and the measured tip velocity. Optionally, the measured tip velocity is calculated as a filtered time derivative of the sensor data projected in the direction of travel. Optionally, the expected velocity is based on an input command. Optionally, controlling the velocity of the distal tip portion of the elongate member includes closed-loop control. For example, the measured tip velocity is processed by a low-pass filter and utilized as a feedback signal for the closed-loop control.

[0014]

[0014] In some embodiments, the distal tip portion includes structure for receiving an imaging device, a position sensor, and an illumination device. In some embodiments, the proximal end of the elongate member of the articulating flexible endoscope is connected to an IDM for applying force to one or more pull wires for articulating the distal tip portion of the elongate member and inserting or withdrawing the articulating flexible endoscope. In some embodiments, the method further includes displaying a message indicative of the buckling event and a recommendation for taking action on the buckling event on a user interface.

[0015]

[0015] In a related yet separate aspect, a system is provided for controlling movement of a tip of an articulating flexible endoscope, the system including a memory storing computer-executable instructions, one or more processors in communication with the articulating flexible endoscope, the one or more processors configured to execute the computer-executable instructions to generate commands to drive an elongated member of the articulating flexible endoscope along an anatomical path via an instrument drive mechanism (IDM), receive sensor data acquired by a position sensor disposed at a distal tip portion of the elongated member, set a motion of the distal tip to zero and calculate a motion of the distal tip portion within a time window when the distal tip portion is determined to be at a preselected position within the anatomical path, calculate a difference between the motion of the distal tip portion and the motion of the IDM within the same time window, and detect a buckling event by comparing the difference to a threshold value.

[0016]

[0016] It should be noted that the various components of the modular endoscopic components and devices provided can be used in a variety of minimally invasive surgical, therapeutic or diagnostic procedures involving various types of tissue, including cardiac, bladder and pulmonary tissue, and other anatomical regions of a patient's body, such as the digestive system, including but not limited to the esophagus, liver, stomach, colon, urinary tract, or the respiratory system, including but not limited to the bronchi, lungs and various others.

[0017]

[0017] Additional aspects and advantages of the present disclosure will be 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 different embodiments, and its several details can be modified in various obvious respects, all without departing from the present disclosure.The drawings and description should therefore be regarded as illustrative in nature, and not as restrictive.

[0018] Incorporation by Reference

[0018] All publications, patents, and patent applications mentioned in this specification are incorporated by reference herein 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 the publications and patents or patent applications incorporated by reference conflict with the disclosure contained herein, the specification is intended to supersede and / or take precedence over any such conflicting matter. [Brief description of the drawings]

[0019]

[0019] The novel features of the invention are set forth with particularity in the appended claims. A more complete 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.") in which:

[0020] [Figure 1] 1 illustrates a schematic diagram of an example of a patient's luminal network. [Diagram 2]

[0021] 1 shows an example of a herniated and buckled flexible elongate member being advanced through an airway / channel. [Diagram 3]

[0022] 1 illustrates an example of a dead zone that occurs during controlled withdrawal of an endoscope. [Figure 4]

[0023] 1 illustrates an exemplary algorithm for controlling the speed of an endoscope tip with safety check operation according to some embodiments of the present disclosure. [Diagram 5]

[0024] 1 illustrates an exemplary warning algorithm. [Figure 6]

[0025] 1 shows an example of the IDM insertion distance and endoscope tip insertion distance at different times. [Figure 7]

[0026] 1 shows an example of dynamic tracking error threshold (DTET) as a function of insertion distance. [Figure 8]

[0027] 1 shows an example of a user interface module. [Figure 9]

[0028] 1 illustrates an example of a robotic endoscopy (e.g., bronchoscopy) system according to some embodiments of the present invention. [Figure 10]

[0029] 1 illustrates an example of a flexible endoscope according to some embodiments of the present disclosure. [Figure 11]

[0030] 1 illustrates an example of a robotic bronchoscope including a handle portion and a flexible elongate member. [Figure 12A]

[0031] An example of an instrument drive mechanism (IDM) that provides a mechanical interface to the handle portion of a robotic bronchoscope is shown. [Figure 12B]

[0032] 1 illustrates an example of a single use endoscope removably coupled to an IDM. [Figure 13]

[0033] 1 shows an example of a distal tip of an endoscope. [Figure 14]

[0034] 1 illustrates an example distal portion of a catheter having an integrated imaging and illumination device. [Figure 15]

[0035] 1 shows an example of a distal portion of a catheter in which an imaging device and an illumination device are integrated. [Figure 16]

[0036] An example of the "zero position" is shown below. [Figure 17]

[0037] 1 shows an example of calculating the motion difference or motion disparity within a predefined time window. [Figure 18]

[0038] 1 illustrates an exemplary algorithm for controlling the movement of an endoscope tip. [Figure 19]

[0039] 1 shows an example of thresholds that vary based on anatomical region. [Figure 20]

[0040] An example of a GUI that displays a warning message is shown below. [Figure 21]

[0040] An example of a GUI that displays a warning message is shown. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0021] Detailed Description of the Invention

[0041] 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, modifications, and substitutions may occur to those skilled in the art without departing from the invention. It is understood that various alternatives to the embodiments of the present invention described herein may be employed.

[0022]

[0042] The embodiments disclosed herein can be combined in one or more of many ways to provide improved diagnosis and treatment to patients. The disclosed embodiments can be combined with existing methods and devices to provide improved treatment, such as combination with known methods of lung diagnosis, surgery, and surgery of other tissues and organs. It is 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 supplementary text provide an explanation according to the embodiments.

[0023]

[0043] Although the exemplary embodiments are directed primarily to devices or systems for bronchoscopy, those skilled in the art will understand that this is not intended to be limiting and that the devices described herein may be used in various anatomical regions of a patient's body for other therapeutic or diagnostic procedures. The provided devices or systems may be utilized in urology, gynecology, rhinology, otology, laryngoscopy, gastroenterology, using endoscopes, composite devices including endoscopes and instruments, endoscopes with localization capabilities, and those skilled in the art will understand that this is not intended to be limiting and that the devices described herein may be utilized in neuroendoscopes, encephaloscopes, ophthalmoscopes, otoscopes, rhinoscopes, laryngoscopes, gastroscopes, esophagoscopes, bronchoscopes, thoracoscopes, pleuroscopes, angioscopes, mediastinoscopes, nephroscopes, gastroscopes, duodenoscopes, choledochoscopes, cholangioscopes, laparoscopes, amnioscopes, ureteroscopes in combination with various tools or instruments. It will be appreciated that the scope may be used in other anatomical regions of a patient's body, such as the brain, heart, lungs, intestines, eyes, skin, kidneys, liver, pancreas, stomach, uterus, ovaries, testes, bladder, ears, nose, mouth, bone marrow, adipose tissue, muscle, glandular and mucosal tissue, spinal cord and nervous tissue, soft tissues such as cartilage, hard biological tissues such as teeth, bones, and body cavities and passageways such as sinuses, ureters, colon, esophagus, pulmonary passageways, blood vessels and pharynx, and various others, for other therapeutic or diagnostic procedures, in the form of a hysteroscope, cystoscope, rectoscope, colonoscope, arthroscope, salivary gland endoscope, orthopedic endoscope, etc.

[0024]

[0044] The systems and devices herein may be combined in one or more of many ways to provide improved diagnosis and treatment to patients. The systems and devices provided herein may be combined with existing methods and devices to provide improved treatment, such as in combination with known methods of lung diagnosis, surgery, and surgery of other tissues and organs. It should be understood that any one or more of the structures and steps described herein may be combined with any one or more additional structures and steps of the methods and devices described herein, and the figures and supplemental text provide an explanation according to the embodiments.

[0025]

[0045] Whenever the terms "at least," "greater than," or "greater than or equal to" are placed before the 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 and every number in the series. For example, 1, 2, or 3 or more is equivalent to 1 or more, 2 or more, or 3 or more.

[0026]

[0046] Whenever the terms "not greater than," "less than," or "less than or equal to" appear before the first number in a series of two or more numbers, the terms "not greater than," "less than," or "less than or equal to" apply to each and every number in the series. For example, 3, 2, or 1 or less is equivalent to 3 or less, 2 or less, or 1 or less.

[0027]

[0047] The terms distal and proximal as used herein may generally refer to a location relative to the device, as opposed to an anatomical reference, for example, a distal location of the main shaft or catheter may correspond to a proximal location of the patient's elongate member, and a proximal location of the main sheath or catheter may correspond to a distal location of the patient's elongate member.

[0028] Highly responsive insertion and withdrawal control

[0048] As discussed above, one challenge in navigating an intraluminal device (e.g., a bronchoscope) is reaching hard-to-reach areas (e.g., upper lobes of the lungs) while navigating through the airways. FIG. 1 illustrates, in a schematic manner, an example of a luminal network 100 of a patient. In the illustrated embodiment, the luminal network 100 is a bronchial network of airways (i.e., lumens, branches) of a patient's lungs. Although the illustrated luminal network 100 is a bronchial network of airways in a patient's lungs, the present disclosure is not limited to only the illustrated example. The systems and methods described herein can be used to navigate any type of luminal network, such as a bronchial network, a renal network, a cardiovascular network (e.g., arteries and veins), a gastrointestinal tract, a urinary tract, etc., as described elsewhere herein.

[0029]

[0049] Access to the periphery through the apical segment (Ap) of the right upper lobe 101 of the lung has been difficult with conventional bronchoscopes. In the example 110 shown in FIG. 1, the sharp 180 degree angle between the trachea and Ap combined with the large space at the junction of the bronchus intermedius, right main bronchus, and right upper lobe bronchus may cause the bronchoscope to kink and / or prolapse downward through the bronchus intermedius. As sections of the elongated device curve as they move through the passageway or passageways, the curved sections are compressed. This compression causes the elongated device to bend and contact the walls of the passageway or passageways along its length. In areas with one or more large passageways around the elongated device, when the distal end of the device encounters tissue resistance, the elongated device may bend within the larger airways and move toward an unintended area of ​​the anatomy rather than the intended direction ("prolapse"). The greater the tissue resistance (e.g., due to airways that are too small, lungs that are not fully inflated, tissue disease, blind insertion, etc.), the greater the likelihood of prolapse. Example 110 shows that deflection / kinking of the endoscope shaft can lead to further deflection into the opposite bronchus (e.g., if the tip is unable to move forward but the operator continues to try to advance the endoscope further).

[0030]

[0050] 2 shows examples of prolapse 210 and buckling 220 during insertion of a flexible device. When a flexible endoscope is pushed at its proximal end during insertion of the flexible device into an anatomical structure, it can deform (210) and buckle (220) as it passes through bends. Deformation can occur during insertion when the flexible device assumes a minimum energy shape that allows for a "snug" shaft against tissue. Buckling can occur when resistance is encountered at the distal portion of the shaft.

[0031]

[0051] During withdrawal of the flexible device, if the system actuation direction is reversed, the "lost in buckling" shaft distance may slacken. This phenomenon results in a perceived dead zone or system lag. For example, user input commanding the movement of the robotic endoscope tip does not map directly to the movement of the robotic endoscope tip. Figure 3 shows an example of a dead zone when controlling endoscope retraction. If the endoscope is buckled, withdrawal of the endoscope may result in robotic actuation with little translational movement of the endoscope tip.

[0032]

[0052] Prolapse or kinking can result in potential damage as it can expose sharp edges of the kinked elongate device, complicating the surgical procedure. Additionally, a bent or kinked elongate device can prevent the system from controlling the device's position / shape during both insertion and withdrawal, preventing the passage of instruments. Additionally, a prolapsed or kinked device may not provide sufficient reach to the target anatomical structure to perform the intended task. Current methods to solve the kink / prolapse problem include detecting prolapse using shape sensing, force sensing, medical imaging of the device's shape and position (comparing detected position to expected position) to detect when prolapse may occur. However, such methods require additional imaging or sensing methods to determine the shape and deformation, which may not provide real-time control of the endoscope tip's movement, adding complexity or cost to the device.

[0033]

[0053] In one aspect of the present disclosure, methods and systems are provided for responsive insertion and withdrawal speed control of a flexible endoscope. The speed control method herein can automatically compensate for differences in motion between the endoscope tip and speed commands (e.g., Instrument Drive Mechanism (IDM) commands). The method for controlling the motion of the tip of a flexible endoscope can have an integrated safety check to detect buckling / deformation.

[0034]

[0054] Unlike conventional methods that detect buckling based on differences in endoscopic device position (e.g., between expected and measured tip positions), the methods and systems herein can automatically correct buckling / deformation during insertion and withdrawal based on measured velocity at the endoscope tip and velocity control commands. This advantageously avoids the use of shape sensing or extra imaging techniques to determine the shape or position of the endoscopic device. Additionally, velocity-based insertion and withdrawal control allows for more responsive automatic buckling correction with minimal delay.

[0035]

[0055] 4 illustrates an exemplary algorithm 400 for controlling the speed of an endoscope tip with integrated safety checks, according to some embodiments of the present disclosure. During insertion (401) of the endoscopic device, a speed command may be received by the endoscopic device. The speed command may be provided by a user input (403). For example, a user may provide a control command indicating a desired / expected speed of the endoscope tip via a control interface of the endoscopic device.

[0036]

[0056] The control interface of the endoscopic device may be part of a user interface module for an operator or user to interact with an endoscope (e.g., a bronchoscope) during a surgical procedure. FIG. 8 shows an example of a user interface module 933. The user interface module may be a handheld controller. The user interface module may optionally include a dedicated user input device and one or more add-on elements removably coupled to an existing user device to enhance the user input experience. For example, a physical trackball or roller may replace or supplement at least one function of a virtual graphical element (e.g., a navigation arrow displayed on a touchpad) displayed in a graphical user interface (GUI), by providing a similar function to the graphical element it replaces. Examples of user devices may include, but are not limited to, a mobile device, a smart phone / cell phone, a tablet, a personal digital assistant (PDA), a laptop or notebook computer, a desktop computer, a media content player, and the like.

[0037]

[0057] The user interface can include a variety of devices, such as a touch screen monitor, joystick, keyboard, and other interactive devices. A user can use the user input devices to navigate and / or control the movement of the robotic arm 911 and the movement (e.g., tip speed) of the catheter 920. The user input devices can include any type of user interactive component, such as buttons, a mouse, a joystick, a trackball, a touchpad, a pen, an image capture device, a motion capture device, a microphone, a touch screen, a handheld wrist gimbal, an exoskeleton glove, or other user interaction system, such as a virtual reality system, an augmented reality system, etc.

[0038]

[0058] User input to command the speed of the endoscope tip may be received via an input device. For example, joystick depressions may be mapped to analog values ​​indicative of tip speed / velocity. For example, a half-press of the joystick may be mapped to 3 mm / s, a full press may be mapped to 6 mm / s, and no press may be mapped to 0 mm / s. The input speed may be any value (e.g., a consecutive number) when the joystick is placed in various positions.

[0039]

[0059] The velocity input may be provided via any suitable user input device. In some cases, the user input device may be a haptic stylus device that physically contacts a touch-sensitive display screen, and the user may control the robotic system by moving the haptic stylus device over the display screen. For example, one or more physical user input devices or add-on elements (e.g., trackballs, joysticks, or rollers) may be haptically or via Bluetooth coupled to a graphical user interface (GUI) provided on the user device. For example, the trackball, joystick, or roller may replace or supplement the functionality of at least one of the virtual graphical elements (e.g., navigation arrows, velocity) displayed in the graphical user interface (GUI), by providing a similar functionality to the graphical element it replaces. The add-on element may be coupled to the GUI via physical contact at a touch screen, via an IO port, wired or wireless communication, and the user input received via the add-on element may be mapped to the input received by the virtual graphical element rendered on the GUI. Examples of user devices include, but are not limited to, mobile devices, smart phones / cell phones, tablets, personal digital assistants (PDAs), laptop or notebook computers, desktop computers, media content players, and the like.

[0040]

[0060] Returning to Figure 4, based on a given user input device, the user input may be processed (405) to be converted into a desired / commanded velocity of the tip of the catheter / endoscope. A tip velocity error is then calculated (407). The tip velocity error is the difference between the desired / commanded tip velocity and the velocity of the endoscope tip. In some embodiments, the velocity of the endoscope tip may be measured based on sensor data. In some cases, the sensor data may include position and orientation information of the distal tip of the endoscope.

[0041]

[0061] In some cases, the sensor signal may be acquired by a positioning sensor. For example, the sensor signal may be acquired by an electromagnetic coil located at the distal end used in conjunction with an electromagnetic tracking system to detect the position and orientation of the distal end of the endoscope 417. For example, a positioning sensor such as an electromagnetic (EM) sensor may be embedded in the distal end of the catheter, and an EM field generator may be positioned next to the patient's torso during the procedure. The EM field generator may determine the position of the EM sensor in 3D space, or may determine the position and orientation of the EM sensor in 5D or 6D space. The endoscope tip position p measured by the EM sensor may be determined by the position of the endoscope tip position p. e =The EM sensor (tip) position can be expressed in the coordinate system of the electromagnetic field generator.

[0042]

[0062] A linear velocity of the endoscope tip can then be calculated based on the measured position data (419). The linear velocity can be calculated using a time differentiation method such as backward Euler differentiation. Optionally, the endoscope tip velocity can be calculated as a filtered time derivative of the tip position (e.g., measured by the EM sensor expressed in the coordinate system of the electromagnetic field generator) projected onto the direction of travel (423). This projection can be necessary because the velocity command provided by the user is based on an integrated position change occurring in the n direction. The EM sensor data can be acquired at a particular frequency, such as 10-60 Hz. Optionally, a low pass filter can be applied to generate filtered time derivative data (421).

[0043]

[0063] The endoscope tip speed is calculated by the projection matrix v n =nn T filt(dp e The tip position may be calculated as the filtered time derivative of the tip position (e.g., measured by the EM sensor expressed in the coordinate system of the electromagnetic field generator) projected onto the direction of travel of n using dp / dt), where n is a unit vector indicating the direction of travel of the endoscope tip expressed in the coordinate system of the electromagnetic field generator. There may be a mechanical offset between the EM sensor and the endoscope tip, which may be calibrated for each endoscope device. e / dt represents the time derivative of the endoscope tip, and nn T is the projection matrix that maps the aforementioned velocities to the direction of travel of the endoscope tip (i.e., velocities that are not in the direction of travel are ignored). Since the translation of the endoscope tip due to articulation is orthogonal to n, the velocity v n may not be affected by joint motion.

[0044]

[0064] After the endoscope tip speed is calculated, an endoscope tip speed error can be calculated (407) and further processed for a safety check (409). In some cases, the safety check (409) can include multiple checks. For example, the multiple checks can include determining whether the endoscope tip is stationary (e.g., tip speed is near zero) while the handle portion of the endoscope (e.g., the IDM) has an insertion distance that exceeds a distance threshold. In another example, the multiple checks can include determining whether the endoscope tip is retracted (e.g., negative tip speed error) while the handle portion of the endoscope (e.g., the IDM) is being inserted, where dislodgement may have occurred. In a further example, the multiple checks can include determining whether an insertion force exceeds a force threshold. As used herein, the term "insertion distance" can refer to a distance along a navigation path.

[0045]

[0065] Method 400 may include closed-loop control of tip speed to reduce tip speed error (411). The tip speed of the endoscope may be controlled based on the tip speed error calculated in operation 407 and used as a feedback signal. FIG. 8 shows a schematic of closed-loop control of tip speed by commanding the movement of the IDM. User speed input may be mapped to a command that controls the movement of the IDM (e.g., a speed for moving the IDM along the insertion axis). The command may be a control signal that controls a motor of the robot arm, thereby controlling the movement of the IDM (i.e., the proximal end of the endoscope). The endoscope tip speed may be calculated based on the inverse kinematics of the robot arm. The endoscope tip speed is then used to calculate the tip speed in the direction of travel by projection in the direction of travel of n using a projection matrix as described above. Optionally, the feedback signal may be a projection of the tip speed that has been processed to filter noise data by a low-pass filter.

[0046]

[0066] 4, based on the control algorithm, motion commands are generated that actuate the robotic arm 413, thereby affecting the tip speed of the endoscope 415. The effect on the IDM motion (e.g., insertion speed, insertion distance) and the effect on the endoscope tip motion (e.g., tip speed) may not match perfectly due to tortuosity, buckling, and / or prolapse of the navigation path, as discussed above.

[0047]

[0067] In some embodiments, multiple safety checks can be combined, sequenced, and selected to trigger a warning or pause in operation according to a warning algorithm. Figure 5 shows an example warning algorithm 500. The warning algorithm can trigger an action, such as a warning or pause in operation, based on one or more of multiple safety checks. In the illustrated method, a warning can be triggered based on a comparison of the endoscope tip insertion distance to the IDM insertion distance.

[0048]

[0068] The process may begin with acquiring EM sensor data (e.g., EM position and orientation signals) (501). An endoscope tip insertion distance may be calculated based on the acquired EM sensor data (e.g., EM position and orientation signals) (503). For example, the endoscope tip insertion distance may be calculated based on sensor orientation information used to distinguish lateral and articulation movements from movements due to robot insertion. Robot joint position data may also be acquired (511). As described later herein, the endoscopic device may be attached to a robot arm via an IDM. The position and orientation of the IDM may be calculated based on the joint position data using forward kinematics (513). The IDM insertion distance is calculated (515) at a series of time points and compared to the tip insertion distance (505).

[0049]

[0069] FIG. 6 shows the IDM insertion distance X at time t601. IDM (t) and the IDM insertion distance X at time t+1 IDM An example of (t+1) is shown. The tip insertion distance is also calculated as Xtip. IDM insertion distance X IDM The difference between the tip insertion distance and the tip insertion distance may be deformation loss. Deformation loss may be due to buckling, prolapse, kinking of the flexible catheter and / or tortuosity of the navigation path. For example, a tortuous path may result in greater deformation loss than following a straight path.

[0050]

[0070] Returning to Figure 5, the difference / discrepancy can be compared to a threshold to determine the presence of buckling. The threshold can be dynamic based on one or more factors, such as the anatomical region and / or the curvature of the navigation path.

[0051]

[0071] In some cases, the dynamic threshold may be referred to as a dynamic tracking error threshold (DTET), which may trigger an alarm and / or system safety action if the tracking error (TE) exceeds the DTET. The tracking error may be deformation loss as described above. As described above, the DTET may be dynamic based at least in part on the anatomical region through which the flexible catheter passes. In some cases, the DTET may be a function of the navigation path, the insertion distance, or the tortuosity of the path. The tortuosity of the path may be calculated, for example, as the ratio of the length of a segment of the path to the distance between its two ends.

[0052]

[0072] FIG. 7 shows examples of dynamic tracking error threshold (DTET) as a function of insertion distance. Example A shows DTET for a less tortuous path, so the overall value of DTET is a function of insertion distance, with a maximum value less than 4 cm. The tracking error (TE) is compared to DTET at various insertion distances, and if TE exceeds DTET for a given insertion distance, an alert, e.g., TE1, can be triggered. Example B shows DTET for a more tortuous path, so the overall value of DTET is a function of insertion distance, with values ​​exceeding 4 cm at certain insertion distances (or certain anatomical regions).

[0053]

[0073] During withdrawal of the medical device, the predetermined deformation losses during insertion can be used as a feedforward term to perform backslash correction for withdrawal control, reducing the deformation losses that occur during insertion prior to tip movement during withdrawal.

[0054]

[0074] The dynamic tracking error threshold may be determined using any suitable method, such as based on historical data, computed tomography (CT) scans of the anatomy, a 3D model of the navigation path, etc. For example, the tortuosity of the path can be calculated for various anatomical regions, segments, and insertion lengths along the path, and the DTET can be varied based on the anatomical region.

[0055]

[0075] Optionally, in addition to the anatomical region, the DTET can also consider the effect of applying an insertion force within a safe range or acceptable deformation range. The safe range describes the range where buckling will not damage contacting tissue or organs inside the patient's body. Such a safe range can be determined based on historical endoscopy and patient data of similar operations in the past. Any suitable method can be used to determine such a safe range. For example, a machine learning algorithm can be used to train a model to determine the safe range. Historical endoscopy and patient data can be used to create a training data set for training the model. The model can be continuously updated and improved as new sensor data is collected.

[0056]

[0076] Returning to Figure 5, a dynamic tracking error threshold can be used to determine if the difference triggers a tip tracking alert (507). The process can then continue to determine if the tip has moved backwards while the IDM is being advanced, i.e., inserted (509). If so, an extrusion may be present and an extrusion alert can be triggered (510).

[0057]

[0077] The warning algorithm 500 is for illustrative purposes only. It should be noted that fewer or more safety checks may be implemented. For example, in addition to pull-out and buckling detection, the algorithm may include checking whether the insertion force exceeds a threshold. The insertion force may be detected by one or more force sensors coupled to the robotic arm of the surgical robotic system. When the insertion force is approaching or approaches the insertion force threshold within a predefined range, the surgical robotic system provides visual, audio and / or tactile feedback to the user via the system GUI. For example, a warning may be displayed in the GUI or provided to the user using suitable UI functionality, indicating that the insertion force is approaching or approaching the insertion force threshold.

[0058]

[0078] In some embodiments, instead of or in addition to detecting the difference in speed, the methods herein can track the difference / disparity between the movement of the insertion of the IDM and the measured tip movement within a time window. For example, the movement of the endoscope tip and the movement of the IDM can be summed within a time window to determine the difference. FIG. 17 shows an example of calculating the difference in movement or the discrepancy in movement within a predefined time window. For example, the distance traveled within each time step in the forward direction (e.g., d1 between T0 and T1, T 1と The time t1, t2, t3, t4, t5, t6, t7, t8, t9, t10, t11, t12, t13, t14, t15, t16, t17, t18, t19, t20, t21, t22, t23, t24, t25, t26, t27, t28, t29, t30, t31, t32, t33, t34, t35, t36, t37, t38, t40, t41, t42, t43, t44, t45, t46, t47, t48, t49, t50, t51, t52, t53, t54, t55, t56, t57, t58, t59, t60, t61, t62, t63, t64, t65, t66, t67, t68, t69, t70, t71, t72, t73, t74, t75, t76, t75, t80, t81, t82, t83, t84, t85, t86, t87, t88, t89, t90, t91, t92, t93, t94, t95, t95, t96, t97, t98, t99, t99, t98, t99

[0059]

[0079] The inconsistency of the tracked movement within the time window may be compared to a threshold value to determine the presence of a buckling event. Optionally, the time window is 4 seconds, 5 seconds, 6 seconds, 7 seconds, 8 seconds, a number less than 5 seconds, a number greater than 8 seconds, or any number between integers. The length of the time window may be selected to allow real-time detection of the buckling event while not overly detecting the inconsistency of the tracked movement within the time window (e.g., 7 seconds). Optionally, the size of the time window may be determined based on empirical data. Optionally, the length of the time window (window size) may be adjusted based on the application (e.g., region of the body), the desired sensitivity level, etc. The length of the time window may be constant throughout the procedure. Alternatively, the length of the time window may be changed as the endoscope is advanced to different regions within the body.

[0060]

[0080] Optionally, forward motion of the IDM and endoscope tip may be tracked only while the endoscope is commanded to be inserted using the controller. Optionally, tracking of motion discrepancies between the IDM and endoscope tip may be reset to zero when the amount of endoscope retraction commanded by the user exceeds a retraction threshold.

[0061]

[0081] As discussed above, the force threshold and / or endoscope tip motion threshold may be based on the tortuosity or anatomical region of the path. FIG. 19 shows an example of thresholds that vary based on anatomical region. In some cases, the dynamic tracking error threshold, motion mismatch threshold and / or force threshold may be determined based on the tortuosity of the path. The amount of force the endoscope tip exerts on the anatomical structures may be determined at least in part based on the force exerted by the IDM in the direction of insertion and the friction between the endoscope and the path to the tip. Higher tortuosity may result in greater friction and therefore less force exerted by the endoscope tip on the anatomical structures for a given amount of force sensed by the IDM. FIG. 19 shows an example of different thresholds that may be selected depending on which section of the lung the endoscope is traveling through. For example, in the upper right region, a high force threshold and a high dynamic tracking error threshold / motion mismatch threshold may be selected due to the high tortuosity, in the upper left region, a medium force threshold and a medium level of dynamic tracking error threshold may be selected due to the medium tortuosity, and in the lower lobe region, a low force threshold and a low dynamic tracking error threshold may be selected due to the low tortuosity. Optionally, the threshold is a function of the tortuosity of the path, which function may be determined based at least in part on an anatomical model of the subject.

[0062]

[0082] This can be difficult to detect using thresholds (e.g., force threshold and dynamic tracking error threshold) because the amount of motion mismatch and end effector force to the main carina of the lungs can be variables that are influenced by the initial setup. For example, as shown in FIG. 16, the amount of motion mismatch and end effector force to the main carina point 1600 can depend on variables in the setup, such as friction within the endotracheal tube, mechanical interface with the bronchial adapter, robot arm angle after withdrawal, endoscope stiffness profile and / or different amounts of lubricant applied to the endoscope. The algorithms and methods herein can beneficially avoid noise or uncertainty introduced by the initial setup conditions by setting the force and / or motion mismatch values ​​to zero as the tip of the endoscope moves along the endotracheal tube 1601 to the main carina 1600. It should be noted that the zero position can be selected as any other suitable position, such as within a distance of the main carina or depending on the anatomy.

[0063]

[0083] Optionally, the main carina location 1600 may be preselected as the zero location. For example, when an endoscope is inserted through the trachea and reaches the main carina point 1600, the system may begin tracking the motion discrepancy starting as zero and comparing it to the motion discrepancy (or dynamic tracking error threshold) as described elsewhere herein. Similarly, when the tip of the endoscope reaches the main carina location 1600, the force may also be set as zero and the system may begin tracking the force and comparing it to the force threshold to detect a safety event.

[0064]

[0084] Optionally, the system may automatically set the force and / or motion mismatch between the IDM motion and the endoscope tip motion to zero when it determines that the endoscope tip is at the main carina 1600. The systems and methods herein may detect the zero position at the main carina using various suitable methods. Optionally, the system may utilize navigation data, such as EM sensor data, to determine whether the endoscope tip has reached the main carina. For example, by tracking the EM sensor data with respect to the tip position within a CT scanned model of the patient's lungs, the system may automatically detect whether the endoscope tip has reached the main carina. Optionally, the system may employ an image recognition algorithm to detect the exit of the endoscope tip from the endotracheal tube 1601 into the trachea. For example, the method may use an image recognition algorithm to process a camera image (e.g., an endoluminal view as shown in FIG. 20 or FIG. 21) to identify a bifurcation at the main carina. Based on the detection of the bifurcation, it may be determined that the endoscope tip is at the main carina 1600. Various other methods may also be utilized to automatically detect the zero position. For example, the endoscope tip may be determined to be at the main carina position 1600 at a certain insertion distance based on human artifacts after the IDM is aligned with the bronchoscope adapter and automatically retracted to the starting position. The above methods of detecting the zero position may be used individually or in any combination.

[0065]

[0085] FIG. 18 illustrates an exemplary algorithm 1800 for controlling the motion of an endoscope tip. The algorithm 1800 may begin by detecting a zero position, such as the main carina (1801). The zero position may be detected using navigation data (e.g., EM sensor data), image recognition methods, and / or other methods, as described above. Upon detecting the zero position, the force and / or motion mismatch on the endoscope tip may be set to zero (1803). The algorithm may also identify which lobe of the lung the endoscope is being driven towards. Based on the target region, a force threshold and a motion threshold (or DTET) may be determined (1805). Optionally, the algorithm may start tracking the motion mismatch within a moving window (e.g., a window size of 7 seconds) and constantly compare it to the motion mismatch threshold. For example, the moving window may have a window size of 7 seconds, and the movement size may be 1 second so that a comparison can be made every second. Optionally, the movement size may be adjusted as 1 second, 2 seconds, 3 seconds, etc. to adjust the detection frequency.

[0066]

[0086] Upon detecting a motion mismatch greater than the motion mismatch threshold, a warning message may be displayed in the GUI informing the user of a possible kink or buckle event. The user may choose to follow the message's recommendations or continue driving the endoscope. Optionally, when a force greater than the force threshold is detected, a warning message may be displayed in the GUI and movement of the robotic arm may be stopped. Optionally, the warning message may provide instructions for the user to remove the endoscope and recover the system (e.g., the system may automatically retract the IDM) (1807). Optionally, if it is detected that the endoscope is driven toward a different anatomical region (e.g., a lobe) (1809), the algorithm may repeat the motion mismatch and set the force to zero (1803) and repeat the process. In the illustrated example, during IDM / endoscope retraction, the algorithm tracks the IDM retraction distance and may use the IDM retraction distance as the endoscope tip retraction distance.

[0067]

[0087] A detected buckling, prolapse, or high insertion force may trigger a warning message and / or a control signal to the system. The warning or feedback message may be provided to the user in a variety of forms. In some cases, the warning or feedback message may indicate the type of problem, such as buckling, prolapse, or unsafe insertion force. For example, the message or warning may be provided for display in a graphical user interface (GUI) rendered on a display that the operator is using to control the operation. In some cases, the system may also generate recommendations for actions to be taken by the user in response to a detected buckling event. For example, the system may generate recommendations for the user to move the endoscope back, adjust the tip movement, reduce / adjust the insertion force provided by the IDM, etc. FIG. 20 illustrates an example of a GUI that displays a warning message. When a buckling of the endoscope is detected, a notification or warning message may be displayed. In the illustrated example, the message may also include a recommendation to withdraw the endoscope or take a fluoroscopic image. FIG. 21 illustrates an example of a warning message triggered by detection of a high insertion force. In this example, a warning message may be displayed in the GUI when an insertion force is detected to exceed a force threshold. The warning message may include information that the robot movement has stopped and a recommendation to the user, such as "remove the endoscope and press the recover button." Optionally, when the user clicks the "Recover" button, the system automatically retracts the IDM.

[0068]

[0088] In some cases, control signals can be generated to alter the operation of the system, the robotic arm, the IDM, and / or the endoscope. For example, based on detection of buckling, prolapse, or high insertion forces, control signals, etc. can be automatically generated to adjust the movement of the endoscope, stop the movement of the endoscope, etc. For example, the control signals can automatically command actuators of the IDM and / or the robotic arm to move the tip of the endoscope to reduce buckling or insertion forces. The speed, movement, and trajectory path for moving the endoscope tip can be automatically determined using algorithms based on sensor data (e.g., EM sensor data).

[0069]

[0089] Flexible endoscope system and device

[0090] In some embodiments, the endoscope tip speed control methods and systems herein may be utilized to improve the reliability and stability of flexible endoscopes. The endoscope tip speed control mechanisms provided may be utilized by any device or apparatus. In one aspect of the invention, flexible endoscopes with improved performance (e.g., improved reliability) are provided.

[0070]

[0091] FIG. 9 illustrates an example of a robotic endoscopy (e.g., bronchoscopy) system 900, 930 according to some embodiments of the present invention. As shown in FIG. 9, the robotic endoscopy (e.g., bronchoscopy) system 900 can include a steerable catheter assembly 920 and a robotic support system 910 that supports or carries the steerable catheter assembly. The steerable catheter assembly can be a bronchoscope. The steerable catheter assembly can be the same as the endoscopic device as described above. In some embodiments, the steerable catheter assembly can be a single-use robotic bronchoscope. In some embodiments, the robotic endoscopy (e.g., bronchoscopy) system 900 can include an instrument drive mechanism (IDM) 913 that is attached to an arm of the robotic support system. The instrument drive mechanism can be provided by any suitable controller device (e.g., a handheld controller) that may or may not include a robotic system. The instrument drive mechanism can provide a mechanical and electrical interface to the steerable catheter assembly 920. The mechanical interface can allow the steerable catheter assembly 920 to be releasably coupled to the instrument drive mechanism. For example, the handle portion of the steerable catheter assembly may be attached to the instrument drive mechanism via a quick attachment / detachment means such as a magnet, a spring-loaded level, etc. In some cases, the steerable catheter assembly may be manually coupled to or disengaged from the instrument drive mechanism without the use of tools.

[0071]

[0092] The steerable catheter assembly 920 can include a handle portion 923 that can include components configured to process image data, provide power, or establish communication with other external devices. For example, the handle portion 923 can include circuitry and communication elements that enable electrical communication between the steerable catheter assembly 920 and the instrument drive mechanism 913 and any other external systems or devices. In another example, the handle portion 223 can include circuitry such as a power supply to provide power to the endoscope's electronics (e.g., camera and LED light). In some cases, the handle portion can electrically communicate with the instrument drive mechanism 913 via an electrical interface (e.g., a printed circuit board) such that image / video data and / or sensor data can be received by the communication module of the instrument drive mechanism and transmitted to other external devices / systems. Alternatively or in addition, the instrument drive mechanism 913 can provide only a mechanical interface. The handle portion can electrically communicate with a modular wireless communication device or any other user device (e.g., a portable / handheld device or controller) to transmit sensor data and / or receive control signals.

[0072]

[0093] The steerable catheter assembly 920 can include a flexible elongate member 911 coupled to a handle portion. In some embodiments, the flexible elongate member can include a shaft, a steerable tip, and a steerable section. The steerable catheter assembly can be a single-use robotic bronchoscope. In some cases, only the elongate member can be disposable. In some cases, at least a portion of the elongate member (e.g., shaft, steerable tip, etc.) can be disposable. In some cases, the entire steerable catheter assembly 920, including the handle portion and elongate member, can be disposable. The flexible elongate member and handle portion are designed to allow the entire steerable catheter assembly to be disposable at low cost.

[0073]

[0094] In some embodiments, the provided bronchoscope system may also include a user interface. As shown in the example system 930, the bronchoscope system may include a procedure interface module 931 (user console side) and / or a procedure control module 933 (patient and robot side). The procedure interface allows an operator or user to interact with the bronchoscope during a surgical procedure. In some embodiments, the procedure control module 933 may be a handheld controller. The procedure control module 933 may allow a user to control the speed of the tip of the bronchoscope, as described elsewhere herein. The procedure control module may optionally include a dedicated user input device and one or more add-on elements removably coupled to an existing user device to enhance the user input experience. For example, a physical trackball or roller may replace or supplement at least one function of a virtual graphical element (e.g., a navigation arrow displayed on a touchpad) displayed in a graphical user interface (GUI), which may be done by providing a similar function to the graphical element it replaces. Examples of user devices may include, but are not limited to, mobile devices, smart phones / cell phones, tablets, personal digital assistants (PDAs), laptop or notebook computers, desktop computers, media content players, etc. More details regarding user interface devices and user consoles are provided later in this specification.

[0074]

[0095] FIG. 10 illustrates an example of a flexible endoscope 1000 according to some embodiments of the present disclosure. As shown in FIG. 10, the flexible endoscope 1000 can include a handle / proximal portion 1009 and a flexible elongate member that is inserted into the subject's body. The flexible elongate member can be the same as described above. In some embodiments, the flexible elongate member can include a proximal shaft (e.g., insertion shaft 1001), a steerable tip (e.g., tip 1005), and a steerable section (active bending section 1003). The active bending section and the proximal shaft section can be the same as described elsewhere herein. The endoscope 100 can also be referred to as a steerable catheter assembly, as described elsewhere herein. In some cases, the endoscope 100 can be a single-use robotic endoscope. In some cases, the entire catheter assembly can be disposable. In some cases, at least a portion of the catheter assembly can be disposable. In some cases, the entire endoscope can be released from the instrument drive mechanism and discarded. In some embodiments, the endoscope can include various levels of stiffness along the shaft to improve functional operation.

[0075]

[0096] The endoscope or steerable catheter assembly 1000 can include a handle portion 1009, which can include one or more components configured to process image data, provide power, or establish communication with other external devices. For example, the handle portion can include circuitry and communication elements that enable electrical communication between the steerable catheter assembly 1000 and an instrument drive mechanism (not shown) and any other external systems or devices. In another example, the handle portion 1009 can include circuitry such as a power supply for powering the endoscope's electronics (e.g., camera, electromagnetic sensor, LED light).

[0076]

[0097] The component or components located in the handle may be optimized to allocate expensive and complex components to the robotic support system, handheld controller, or instrument drive mechanism, thereby reducing the cost and simplifying the design of the single-use endoscope. The handle or proximal portion may provide an electrical and mechanical interface to allow electrical communication and mechanical transmission with the instrument drive mechanism. The instrument drive mechanism may include a set of motors that operate to rotationally drive a set of pull wires of the catheter. The handle portion of the catheter assembly may be attached to the instrument drive mechanism such that its pulley / capstan assembly is driven by its set of motors. The number of pulleys may vary depending on the configuration of the pull wires. In some cases, one, two, three, four or more pull wires may be utilized to articulate the flexible endoscope or catheter.

[0077]

[0098] The handle portion may be designed so that the robotic bronchoscope may be disposable at reduced cost. For example, conventional manual bronchoscopes and robotic bronchoscopes may have a cable at the proximal end of the bronchoscope handle. This cable often includes illumination fibers, camera video cables, and other sensor fibers or cables, such as electromagnetic (EM) sensors or shape-sensing fibers. Such complex cables may be expensive and increase the cost of the bronchoscope. The provided robotic bronchoscope may have an optimized design so that simplified structures and components may be employed while maintaining mechanical and electrical functionality. In some cases, the handle portion of the robotic bronchoscope may employ a cable-less design while providing a mechanical / electrical interface to the catheter.

[0078]

[0099] The electrical interface (e.g., a printed circuit board) may enable image / video data and / or sensor data to be received by the communication module of the instrument drive mechanism 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 to an electronic board such as a printed circuit board (PCB). For example, a receptacle connector (e.g., a female connector) is provided on the instrument drive mechanism as a mating interface. This may advantageously allow an endoscope to be quickly plugged into the instrument drive mechanism or robot support without utilizing extra cables. Such a type of electrical interface may also serve as a mechanical interface such that when the handle portion is plugged into the instrument drive mechanism, both a mechanical linkage and an electrical coupling are established. Alternatively or in addition, the instrument drive mechanism may provide only the mechanical interface. The handle portion may electrically communicate with the modular wireless communication device or any other user device (e.g., a portable / handheld device or controller) to transmit sensor data and / or receive control signals.

[0079]

[0100] Optionally, the handle portion 1009 may include one or more mechanical control modules, such as a luer 1011 for interfacing the irrigation / aspiration system. Optionally, the handle portion may include a lever / knob for articulation control. Alternatively, the articulation control may be located on a separate controller attached to the handle portion via the instrument drive mechanism.

[0080]

[0101] The endoscope may be attached to a robotic support system or a handheld controller via an instrument drive mechanism. The instrument drive mechanism may be provided by any suitable controller device (e.g., a handheld controller) that may or may not include a robotic system. The instrument drive mechanism may provide a mechanical and electrical interface to the steerable catheter assembly 1000. The mechanical interface may allow the steerable catheter assembly 1000 to be releasably coupled to the instrument drive mechanism. For example, a handle portion of the steerable catheter assembly may be attached to the instrument drive mechanism via a quick attachment / detachment means such as a magnet, a spring level, or the like. In some cases, the steerable catheter assembly may be manually coupled to or released from the instrument drive mechanism without the use of tools.

[0081]

[0102] In the illustrated example, the distal tip of the catheter or endoscope shaft is configured to articulate / bend with two or more degrees of freedom to provide a desired camera view or control the direction of the endoscope. As shown in the example, an imaging device (e.g., camera), a position sensor (e.g., electromagnetic sensor) 1007 is located at the tip 1005 of the catheter or endoscope shaft. For example, the line of sight of the camera can be controlled by controlling the articulation of the active bending section 1003. In some cases, the angle of the camera can be adjustable such that the line of sight can be adjusted without or in addition to articulating the distal tip of the catheter or endoscope shaft. For example, the camera can be oriented at an angle (e.g., tilt) relative to the axial direction of the tip of the endoscope utilizing suitable components.

[0082]

[0103] The distal tip 1005 may be a rigid component that allows for positioning of sensors such as electromagnetic (EM) sensors, imaging devices (e.g., cameras) and other electronic components (e.g., LED light sources) embedded in the distal tip.

[0083]

[0104] In real-time EM tracking, an EM sensor including one or more sensor coils embedded in a medical instrument (e.g., the tip of an endoscopic tool) at one or more positions and orientations measures the variations in an EM field generated by one or more static EM field generators positioned at locations close to the patient. The position information detected by the EM sensor is stored as EM data. The EM field generator (or transmitter) may be placed close to the patient to generate a low-intensity magnetic field that can be detected by the embedded sensor. The magnetic field induces a small current in the sensor coil of the EM sensor, and the current can be analyzed to determine the distance and angle between the EM sensor and the EM field generator. For example, the EM field generator can be positioned close to the patient's torso during the procedure to locate the EM sensor in 3D space, or the position and orientation of the EM sensor can be located in 5D or 6D space. This can provide a visual guide to the operator when maneuvering the bronchoscope toward the target site.

[0084]

[0105] The endoscope can have a unique design in the elongate member. In some cases, the active bending section 1003 and the proximal shaft of the endoscope can be constructed from a single tube incorporating a series of discontinuities (e.g., reliefs, slits, etc.) along its length to allow for increased flexibility, desirable stiffness, as well as anti-pullout functionality (e.g., defining a minimum bend radius).

[0085]

[0106] As discussed above, the active bending section 1003 may be designed to allow bending (e.g., articulation) in more than one degree of freedom. Larger degrees of bending, such as 180 degrees and 270 degrees (or other articulation parameters for clinical indications), may be achieved by the unique construction of the active bending section. In some cases, variable minimum bending radii may be provided along the axial direction of the elongate member such that the active bending section may include two or more different minimum bending radii.

[0086]

[0107] Articulation of the endoscope may be controlled by applying force to the distal end of the endoscope via one or more pull wires. One or more pull wires may be attached to the distal end of the endoscope. With multiple pull wires, pulling one wire at a time may change the orientation of the distal tip to adjust up, down, left, right, or any direction required. Optionally, the pull wires may be secured at the distal tip of the endoscope to extend through the bending section and into a handle where they are coupled to a drive component (e.g., a pulley). This handle pulley may interface with an output shaft from a robotic system.

[0087]

[0108] In some embodiments, the proximal end or portion of the pull wire(s) may be operatively coupled to various mechanisms (e.g., gears, pulleys, capstans, etc.) within the handle portion of the catheter assembly. The pull wires may be metal wires, cables, or threads, or may be polymeric wires, cables, or threads. The pull wires may also be made of natural or organic materials or fibers. The pull wires may be any type of suitable wire, cable, or thread that can support various types of loads without deformation, significant deformation, or breakage. The distal end / portion of the pull wire(s) may be fixed or integral to the distal portion of the catheter, such that manipulation of the pull wires by the control unit can apply a force or tension to the distal portion that can steer or articulate at least the distal portion (e.g., flexible section) of the catheter (e.g., up, down, pitch, yaw, or any direction in between).

[0088]

[0109] The pull wires may be made of any suitable material, such as stainless steel (e.g., SS316), metals, alloys, polymers, nylon, or biocompatible materials. The pull wires may be wires, cables, or threads. In some embodiments, different pull wires may be made of different materials to vary the load-bearing capabilities of the pull wires. In some embodiments, different sections of the pull wires may be made of different materials to vary stiffness and / or load-bearing properties along the pull wire. In some embodiments, the pull wires may be utilized for the transmission of electrical signals.

[0089]

[0110] The proximal design can improve the reliability of the device without introducing extra costs, allowing for a low-cost single-use endoscope. In another aspect of the present invention, a single-use robotic endoscope is provided. The robotic endoscope can be a bronchoscope and can be the same as a steerable catheter assembly as described elsewhere herein. Conventional endoscopes can be complex in design and are usually designed to be reused after a procedure, requiring extensive cleaning, disinfection or sterilization after each procedure. Existing endoscopes are often designed with complex structures to ensure that the endoscope can withstand cleaning, disinfection and sterilization processes. The provided robotic bronchoscope can be a single-use endoscope that can beneficially reduce cross-contamination and infection between patients. In some cases, the robotic bronchoscope can be delivered to the physician in a pre-sterilized package and is intended to be discarded after a single use.

[0090]

[0111] As shown in FIG. 11, the robotic bronchoscope 1120 can include a handle portion 1113 and a flexible elongate member 1111. In some embodiments, the flexible elongate member 1111 can include a shaft, a steerable tip, and a steerable / active bending section. The robotic bronchoscope 1120 can be the same as the steerable catheter assembly as described in FIG. 10. The robotic bronchoscope can be a single-use robotic endoscope. 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 discarded. In some cases, the bronchoscope can include different levels of stiffness along its shaft to improve functional operation. In some cases, the minimum bend radius along the shaft can be different.

[0091]

[0112] The robotic bronchoscope may be releasably coupled to an instrument drive mechanism 1120. The instrument drive mechanism 1120 may be attached to an arm of a robotic support system or any actuation support system as described elsewhere herein. The instrument drive mechanism may provide a mechanical and electrical interface to the robotic bronchoscope 1110. The mechanical interface may allow a steerable robotic bronchoscope to be releasably coupled to the instrument drive mechanism. For example, a handle portion of the robotic bronchoscope may be attached to the instrument drive mechanism via a quick attachment / detachment means such as a magnet, a spring level, or the like. In some cases, the robotic bronchoscope may be manually coupled to or released from the instrument drive mechanism without the use of tools.

[0092]

[0113] 12A shows an example of an instrument drive mechanism (IDM) 1220 that provides a mechanical interface to a handle portion 1213 of a robotic bronchoscope. As shown in this example, the instrument drive mechanism 1220 can include a set of motors that operate to rotationally drive a set of pull wires of a flexible endoscope or catheter. The handle portion 1213 of the catheter assembly can be attached to the instrument drive mechanism such that its pulley assembly or capstan is driven by the set of motors. The number of pulleys can vary based on the configuration of the pull wires. In some cases, one, two, three, four or more pull wires can be utilized to articulate the flexible endoscope or catheter.

[0093]

[0114] The handle portion may be designed so that the robotic bronchoscope may be disposable at reduced cost. For example, conventional manual bronchoscopes and robotic bronchoscopes may have a cable at the proximal end of the bronchoscope handle. This cable often includes illumination fibers, camera video cables, and other sensor fibers or cables, such as electromagnetic (EM) sensors or shape-sensing fibers. Such complex cables may be expensive and increase the cost of the bronchoscope. The provided robotic bronchoscope may have an optimized design so that simplified structures and components may be employed while maintaining mechanical and electrical functionality. In some cases, the handle portion of the robotic bronchoscope may employ a cable-less design while providing a mechanical / electrical interface to the catheter.

[0094]

[0115] FIG. 12B shows another example of a single use endoscope 1200 removably coupled to an IDM 1201. One or more components located in the handle 1209 may be optimized to allocate expensive and complex components to the robotic support system 1203, handheld controller, or instrument drive mechanism 1201, thereby reducing the cost of the single use endoscope and simplifying the design. The handle or proximal portion 1209 may provide electrical and mechanical interfaces to allow electrical and mechanical communication with the instrument drive mechanism 1201. The instrument drive mechanism 1201 may include a set of motors that operate to rotationally drive a set of pull wires of the catheter. The handle portion 1209 of the catheter assembly may be attached to the instrument drive mechanism 1201 such that its pulley / capstan assembly is driven by its set of motors. For example, the handle pulleys may interface with an output shaft 1203 from an IDM supported by the robotic system. The number of pulleys may vary depending on the configuration of the pull wires. Optionally, one, two, three, four or more pull wires may be utilized to articulate a flexible endoscope or catheter.

[0095]

[0116] FIG. 13 shows an example of a distal tip 1300 of an endoscope. In some cases, the distal portion or tip 1300 of the catheter can be substantially flexible so that it can be steered in one or more directions (e.g., pitch, yaw). The catheter can include a tip section, a bending section, and an insertion shaft. In some embodiments, the catheter can have a variable bending stiffness along the direction of the longitudinal axis. For example, the catheter can include multiple sections with different bending stiffnesses (e.g., flexible, semi-rigid, and rigid). The bending stiffness can be varied by selecting materials with different hardness / rigidity, varying the structure (e.g., cuts, patterns) in different segments, adding additional support components, or any combination of the above. In some embodiments, the catheter can have a variable minimum bending radius along the longitudinal axis. Selecting different minimum bending radii at different locations along the catheter can advantageously provide anti-prolapse capabilities while still allowing the catheter to reach hard-to-reach areas. In some cases, the proximal end of the catheter does not need to bend highly, and therefore the proximal portion of the catheter can be reinforced with additional mechanical structure (e.g., additional layers of material) to achieve greater bending stiffness. Such a design can provide support and stability to the catheter. In some cases, variable bending stiffness can be achieved by using different materials during the extrusion of the catheter. This can advantageously allow for different stiffness levels along the shaft of the catheter in the extrusion manufacturing process without additional fastening or assembly of different materials.

[0096]

[0117] The distal portion of the catheter may be steered by one or more pull wires 1305. The distal portion of the catheter may be made of any suitable material, such as a copolymer, polymer, metal or alloy, so that it can be bent by the pull wires. In some embodiments, the proximal or distal end of the one or more pull wires 1305 may be coupled to a drive mechanism (e.g., gears, pulleys, capstans, etc.) via a fastening mechanism, as described above.

[0097]

[0118] The pull wire 1305 may be a metal wire, cable or thread, or may be a polymer wire, cable or thread. The pull wire 1305 may also be made of natural or organic materials or fibers. The pull wire 1305 may be any type of suitable wire, cable or thread capable of supporting various types of loads without deformation, significant deformation or breakage. A distal end or portion of one or more pull wires 1305 may be fixed or integral to a distal portion of the catheter, such that manipulation of the pull wire by a control unit can apply a force or tension to the distal portion that can steer or articulate at least a distal portion (e.g., flexible section) of the catheter (e.g., up, down, pitch, yaw, or any direction in between).

[0098]

[0119] The catheter can have dimensions that allow one or more electronic components to be incorporated into the catheter. For example, the outer diameter of the distal tip can be about 4 to 4.4 millimeters (mm) and the diameter of the working channel can be about 2 mm so that one or more electronic components can be embedded into the wall of the catheter. However, it is noted that based on various applications, the outer diameter can be any range less than 4 mm or greater than 4.4 mm, and the diameter of the working channel can be any range according to the dimensions of the tool or a given application.

[0099]

[0120] The one or more electronic components may include an imaging device, an illumination device, or a sensor. In some embodiments, the imaging device may be a video camera 1313. The imaging device may include an optical element and an image sensor for capturing image data. The image sensor may be configured to generate image data according to wavelengths of light. Various image sensors may be employed for capturing image data, such as complementary metal oxide semiconductor (CMOS) or charge-coupled device (CCD). The imaging device may be a low-cost camera. In some cases, the imaging device 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 image signals. For example, the circuit for the CCD sensor may include an A / D converter and an amplifier that amplifies and converts an analog signal provided from the CCD sensor. Optionally, the image sensor may be integrated with an amplifier and a converter that converts an analog signal to a digital signal, such that a circuit board may not be required. In some cases, the output of the image sensor or circuit board may be image data (digital signal) that can be further processed by the camera circuit or a processor of the camera. In some cases, the image sensor may include an array of optical sensors.

[0100]

[0121] The illumination device can include one or more light sources 1311 positioned at the distal tip. The light sources can be light emitting diodes (LEDs), organic LEDs (OLEDs), quantum dots, or any other suitable light source. In some cases, the light sources can be miniaturized LEDs or dual-tone flash LED illumination for compact designs.

[0101]

[0122] The imaging and lighting devices may be integrated into the catheter. For example, the distal portion of the catheter may include suitable structure that matches at least the dimensions of the imaging and lighting devices. The imaging and lighting devices may be embedded into the catheter. FIG. 14 shows an example distal portion of a catheter with an integrated imaging and lighting device. The camera may be located in the distal portion. The distal tip may have structure for receiving the camera, lighting device and / or position sensor. For example, the camera may be embedded in a cavity 1410 in the distal tip of the catheter. The cavity 1410 may be integrally formed with the distal portion of the cavity and may have dimensions that match the length / width of the camera such that the camera cannot move relative to the catheter. The camera may be adjacent to the working channel 1420 of the catheter to provide a near-field view of the tissue or organ. Optionally, the attitude or orientation of the imaging device may be controlled by controlling the rotational movement (e.g., roll) of the catheter.

[0102]

[0123] Power to the camera may be provided by a wired cable. Optionally, the cable lines may be in a wiring bundle that provides power to the camera as well as lighting elements or other circuitry at the distal tip of the catheter. The camera and / or light source may be powered from a power source located in the handle portion via electrical wires, copper wires, or any other suitable means that run through the length of the catheter. Optionally, real-time images or videos of the tissue or organ may be wirelessly transmitted to an external user interface or display. Wireless communication may be WiFi, Bluetooth, RF communication, or other forms of communication. Optionally, images or videos captured by the camera may be broadcast to multiple devices or systems. Optionally, image and / or video data from the camera may be transmitted down the length of the catheter to a processor located in the handle portion via electrical wires, copper wires, or any other suitable means. Image or video data may be transmitted to an external device / system via a wireless communication component in the handle portion. Optionally, the system may be designed such that the wires are not visible or exposed to the operator.

[0103]

[0124] In traditional endoscopy, illumination light may be provided by a fiber cable that transmits light from a light source located at the proximal end of the endoscope to the distal end of the robotic endoscope. In some embodiments of the present disclosure, miniaturized LED illumination may be employed and embedded in the distal portion of the catheter to reduce design complexity. Optionally, the distal portion may include a structure 1430 having dimensions that match the dimensions of the miniaturized LED light source. As shown in the illustrated example, two cavities 1430 may be integrally formed with the catheter to receive two LED light sources. For example, the outer diameter of the distal tip may be about 4-4.4 millimeters (mm) and the diameter of the working channel of the catheter may be about 2 mm so that two LED light sources can be embedded in the distal end. The outer diameter may be any range smaller than 4 mm or larger than 4.4 mm and the diameter of the working channel may be any range according to the dimensions of the tool or a given application. Any number of light sources may be included. The internal structure of the distal portion may be designed to accommodate any number of light sources.

[0104]

[0125] Optionally, each of the LEDs may be connected to a power wire that may extend to the proximal handle. In some embodiments, the LEDs may be soldered to separate power wires that are later bundled together to form one strand. In some embodiments, the LEDs may be soldered to a pull wire that provides power. In other embodiments, the LEDs may be crimped or connected directly to a pair of power wires. Optionally, 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. Optionally, an additional cover 1431 may be placed on the forward end face of the distal tip to provide sufficient space for the adhesive along with accurate positioning of the LEDs. The cover 1431 may be made of a transparent material that matches the index of refraction of the adhesive so that the illumination light cannot be obstructed.

[0105]

[0126] It should be noted that the design of the distal end shown is for illustrative purposes only. There may be other suitable designs for integrating one or more components at the distal tip. FIG. 15 shows another example of a distal portion 1500 of a catheter integrating an imaging device and an illumination device. As shown in the example 1500, the distal tip may have a structure 1501 for receiving a camera, a structure 1503 for receiving an illumination device, and / or a position sensor. The camera may be embedded in a cavity 1501 at the distal tip of the catheter. The cavity 1501 may be integrally formed with the distal portion of the cavity and may have dimensions matching the length / width of the camera such that the camera cannot move relative to the catheter. The camera may be adjacent to the working channel 1507 of the catheter to provide a near-field view of the tissue or organ. Optionally, the attitude or orientation of the imaging device may be controlled by controlling the rotational movement (e.g., roll) of the catheter. As shown in the illustrated example 1500, a cavity 1503 may be integrally formed with the catheter to receive an LED light source.

[0106]

[0127] In one aspect, a system for controlling movement of a tip of an articulating flexible endoscope is provided, the system including a memory storing computer-executable instructions, one or more processors in communication with the articulating flexible endoscope configured to execute the computer-executable instructions to generate commands to drive an elongated member of the articulating flexible endoscope along an anatomical path via an instrument drive mechanism (IDM), receive sensor data acquired by a position sensor disposed at a distal tip portion of the elongated member, set a motion of the distal tip to zero and calculate a motion of the distal tip portion within a time window when the distal tip portion is determined to be at a preselected position within the anatomical path, calculate a difference between the motion of the distal tip portion and the motion of the IDM within the same time window, and detect a buckling event by comparing the difference to a threshold value.

[0107]

[0128] A processor as used herein 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 that stores instructions implementing steps of a process, and a processor may include, for example, one or more of a central processing unit, a programmable array logic, a gate array logic, or a field programmable gate array. In some cases, the one or more processors may be a programmable processor (e.g., a central processing unit (CPU) 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 operatively 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 a 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.

[0108]

[0129] The one or more processors can be in communication with the endoscope. The one or more processors can be located remotely from the endoscope system or on-board the endoscope system (e.g., located in the handle and in a user device that controls the endoscope).

[0109]

[0130] While preferred 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 will occur to those skilled in the art without departing from the present invention. It is understood that various alternatives to the embodiments of the present invention described herein may be employed in practicing the present invention. It is intended that the following claims define the scope of the present invention and that methods and structures within the scope of these claims and their equivalents be covered thereby.

Claims

1. 1. A method for controlling movement of a tip of an articulating flexible endoscope, comprising: generating commands to drive an elongate member of the articulating flexible endoscope along an anatomical path via an instrument drive mechanism (IDM); receiving sensor data acquired by a position sensor disposed at a distal tip portion of the elongate member; setting a motion of the distal tip portion to zero when the distal tip portion is determined to be at a preselected location within the anatomical path, and calculating the motion of the distal tip portion within a time window; calculating a difference between the movement of the distal tip portion and the movement of the IDM within the same time window; detecting a buckling event by comparing said difference with a threshold value; The method includes:

2. The method of claim 1 , wherein the preselected location is the main carina.

3. The method of claim 1 , further comprising determining that the distal tip portion is at the preselected position based at least in part on the sensor data and a 3D model of the anatomical path.

4. The method of claim 3 , wherein the position sensor comprises an electromagnetic sensor.

5. The method of claim 1 , further comprising determining that the distal tip portion is at the preselected position based at least in part on image data acquired by a camera located at the distal tip portion.

6. The method of claim 1 , wherein the threshold is dynamically determined based on a target anatomical region toward which the articulating flexible endoscope is moving.

7. The method of claim 1 , wherein the threshold is a function of the tortuosity of the anatomical path.

8. The method of claim 1 , wherein the size of the time window is between 4 seconds and 8 seconds.

9. The method of claim 8 , wherein the size of the time window is determined based on empirical data.

10. The method of claim 1 , wherein the movement of the distal tip portion within the time window is an accumulation of the distance traveled in each time step.

11. 10. The method of claim 1, further comprising setting an insertion force applied by the IDM to zero upon determining that the distal tip portion is at the preselected location within the anatomical pathway, and comparing the insertion force to a force threshold.

12. The method of claim 11 , further comprising generating and displaying a warning message on a user interface upon determining that the insertion force exceeds the force threshold.

13. The method of claim 1 , further comprising controlling a velocity of the distal tip portion of the elongate member based on a difference between an expected velocity and a measured tip velocity.

14. The method of claim 13 , wherein the measured tip speed is calculated as a filtered time derivative of the sensor data projected in the direction of travel.

15. The method of claim 13 , wherein the expected speed is based on an input command.

16. The method of claim 14 , wherein controlling the velocity of the distal tip portion of the elongate member comprises closed loop control.

17. 17. The method of claim 16, wherein the measured tip speed is processed by a low pass filter and utilized as a feedback signal for the closed loop control.

18. The method of claim 1 , wherein the distal tip portion includes structure for receiving an imaging device, the position sensor, and an illumination device.

19. 2. The method of claim 1, wherein a proximal end of the elongated member of the articulating flexible endoscope is connected to an IDM for applying force to one or more pull wires to articulate the distal tip portion of the elongated member and insert or withdraw the articulating flexible endoscope.

20. The method of claim 1 , further comprising displaying a message in a user interface indicating the buckling event and a recommendation for taking action in response to the buckling event.

21. 1. A system for controlling movement of a tip of an articulating flexible endoscope, comprising: a memory storing computer-executable instructions; and one or more processors in communication with the articulating flexible endoscope, the processor or processors executing the computer-executable instructions to: generating commands to drive an elongate member of the articulating flexible endoscope along an anatomical path via an instrument drive mechanism (IDM); receiving sensor data acquired by a position sensor disposed at a distal tip portion of the elongate member; setting a motion of the distal tip portion to zero when the distal tip portion is determined to be at a preselected location within the anatomical path, and calculating the motion of the distal tip portion within a time window; calculating a difference between the movement of the distal tip portion and the movement of the IDM within the same time window; detecting a buckling event by comparing said difference with a threshold value; 1. A system including one or more processors configured to:

22. 22. The system of claim 21, wherein the preselected location is the main carina.

23. 22. The system of claim 21, wherein the one or more processors are further configured to determine that the distal tip portion is at the preselected position based at least in part on the sensor data and a 3D model of the anatomical path.

24. The system of claim 23 , wherein the position sensor includes an electromagnetic sensor.

25. 22. The system of claim 21, wherein the one or more processors are further configured to determine that the distal tip portion is in the preselected position based at least in part on image data acquired by a camera located at the distal tip portion.

26. 22. The system of claim 21, wherein the threshold is dynamically determined based on a target anatomical region toward which the articulating flexible endoscope is moving.

27. 22. The system of claim 21, wherein the threshold is a function of the tortuosity of the anatomical path.

28. The system of claim 21 , wherein the size of the time window is between 4 seconds and 8 seconds.

29. 30. The system of claim 28, wherein the size of the time window is determined based on empirical data.

30. 22. The system of claim 21, wherein the movement of the distal tip portion within the time window is an accumulation of the distance traveled in each time step.

31. 22. The system of claim 21, wherein the one or more processors are further configured to set an insertion force applied by the IDM to zero when the distal tip portion is determined to be at the preselected position within the anatomical pathway and to compare the insertion force to a force threshold.

32. 32. The system of claim 31, wherein the one or more processors are further configured to generate and display on a user interface a warning message upon determining that the insertion force exceeds the force threshold.

33. 22. The system of claim 21, wherein the one or more processors are further configured to control a velocity of the distal tip portion of the elongate member based on a difference between an expected velocity and a measured tip velocity.

34. 34. The system of claim 33, wherein the measured tip speed is calculated as a filtered time derivative of the sensor data projected in the direction of travel.

35. 34. The system of claim 33, wherein the predicted velocity is based on an input command.

36. 35. The system of claim 34, wherein the velocity of the distal tip portion of the elongate member is controlled using closed loop control.

37. 37. The system of claim 36, wherein the measured tip speed is processed by a low pass filter and utilized as a feedback signal for the closed loop control.

38. The system of claim 31 , wherein the distal tip portion includes structure for receiving an imaging device, the position sensor, and an illumination device.

39. 32. The system of claim 31 , wherein the proximal end of the elongated member of the articulating flexible endoscope is connected to an IDM for applying force to one or more pull wires to articulate the distal tip portion of the elongated member and insert or withdraw the articulating flexible endoscope.

40. 32. The system of claim 31, wherein the one or more processors are further configured to display a message in a user interface indicating the buckling event and a recommendation for taking action in response to the buckling event.

Images