Conditional brake engagement to suppress reverse drive of system components

Abstract

A medical system includes a manipulator assembly and a control system coupled to the manipulator assembly. The manipulator assembly comprises: an actuator for driving the medical device along an insertion axis of the manipulator assembly; and a brake for inhibiting movement of the medical instrument along the insertion axis. The control system is configured to: determine whether the medical system is in a first operating mode or a second operating mode, the first operating mode involving actuator-driven movement of the medical instrument along the insertion axis, the second operating mode involving no actuator-driven movement of the medical instrument along the insertion axis; and based on determining that the medical system is in the second mode of operation, controlling the brake to inhibit movement of the medical device along the insertion axis caused by the external force.

Description

[0001] Cross-reference to related applications

[0002] This application is based on 35 U SC 119(e) claims the benefit of priority to U.S. Provisional Patent Application Serial No. 63 / 535,922, filed August 31, 2023, which is incorporated herein by reference in its entirety. Technical Field

[0003] The disclosed embodiments relate to improved robots and / or medical devices, systems, and methods. Background Technology

[0004] Minimally invasive medical techniques aim to reduce the amount of tissue damaged during medical procedures, thereby reducing patient recovery time, discomfort, and harmful side effects. Such techniques can be performed through natural openings in the patient's anatomy or through one or more surgical incisions. Through these natural openings or incisions, physicians can insert minimally invasive medical instruments (including surgical, diagnostic, therapeutic, and / or biopsy instruments) to reach target tissue locations. One such technique utilizes flexible and / or steerable elongated devices (such as flexible catheters or bronchoscopes) that can be inserted into the anatomical passage and navigated toward regions of interest within the patient's anatomy.

[0005] Under some operating conditions, a medical device may be driven along one or more axes of movement, while under other operating conditions, the medical device is not driven and remains stationary. In such cases, unintended back-driving caused by external forces acting on the medical system may cause undesirable movement of the medical device. Summary of the Invention

[0006] The following presents a brief overview of the various examples described herein and is not intended to identify key or important elements or to depict the scope of the claims.

[0007] In some examples, a medical system includes: a manipulator assembly comprising: an actuator for driving a medical device along an insertion axis of the manipulator assembly; and a brake for inhibiting movement of the medical device along the insertion axis; and a control system coupled to the manipulator assembly, the control system being configured to: determine whether the medical system is in a first operating mode or a second operating mode, the first operating mode involving actuator-driven movement of the medical device along the insertion axis, the second operating mode involving no actuator-driven movement of the medical device along the insertion axis; and based on determining that the medical system is in the second operating mode, control the brake to inhibit movement of the medical device along the insertion axis caused by external force.

[0008] In some examples, a non-transitory machine-readable medium includes a plurality of machine-readable instructions executable by one or more processors associated with a medical system, the plurality of machine-readable instructions causing one or more processors to perform a method comprising: determining whether the medical system is in a first operating mode or a second operating mode, the first operating mode relating to actuator-driven movement of a medical device along an insertion axis, the second operating mode relating to no actuator-driven movement of the medical device along the insertion axis; and, based on determining that the medical system is in the second operating mode, controlling a brake to suppress movement of the medical device along the insertion axis caused by an external force.

[0009] In some examples, a method for operating a medical system includes: determining whether the medical system is in a first operating mode or a second operating mode, the first operating mode involving actuator-driven movement of a medical device along an insertion axis, and the second operating mode involving no actuator-driven movement of the medical device along the insertion axis; and based on determining that the medical system is in the second operating mode, controlling a brake to suppress movement of the medical device along the insertion axis caused by an external force.

[0010] It should be understood that both the foregoing general description and the following detailed description are exemplary and illustrative in nature and are intended to provide an understanding of this disclosure without limiting its scope. In this regard, additional aspects, features, and advantages of this disclosure will be apparent to those skilled in the art from the following detailed description. Attached Figure Description

[0011] Figure 1 This is a simplified diagram of a medical system based on some implementation methods.

[0012] Figure 2A This is a simplified diagram of a medical device system according to some implementation methods.

[0013] Figure 2B This is a simplified diagram of a medical device including a medical tool within a flexible elongation device, according to some embodiments.

[0014] Figure 2C This is a simplified perspective view of a manipulator assembly including an instrument and a manipulator arm that holds the instrument, according to some embodiments.

[0015] Figure 2D A cross-sectional view of an actuator-brake assembly according to some embodiments is shown.

[0016] Figure 3A and Figure 3B This is a simplified side view of a medical device mounted on an insertion assembly in patient coordinate space, according to some embodiments.

[0017] Figure 4 This is a simplified perspective view of the input console according to some implementation methods.

[0018] Figure 5 This is a diagram illustrating the operating mode of a medical system according to some implementation methods.

[0019] Figure 6 This is a flowchart of a method according to some implementation methods.

[0020] The embodiments and advantages of this disclosure can be better understood by referring to the following detailed description. It should be understood that the same reference numerals are used to identify the same elements shown in one or more of the accompanying drawings, which are shown for illustrative purposes only and not for limiting the embodiments of this disclosure. Detailed Implementation

[0021] In the following description, specific details of some embodiments consistent with this disclosure are set forth. Numerous specific details are set forth to provide a thorough understanding of the embodiments. However, it will be apparent to those skilled in the art that some embodiments may be practiced without some or all of these specific details. The specific embodiments disclosed herein are intended to be exemplary and not restrictive. Other elements within the scope and spirit of this disclosure can be implemented by those skilled in the art, although not specifically described herein. Furthermore, to avoid unnecessary repetition, one or more features shown and described in association with one embodiment may be incorporated into other embodiments unless otherwise specifically described or if one or more features would render the embodiment inoperable. In some cases, well-known methods, processes, components, and circuits have not been described in detail to avoid unnecessarily obscuring aspects of the embodiments.

[0022] This disclosure describes various instruments and parts thereof based on their state in three-dimensional space. As used herein, the term “position” refers to the location of an object or part of an object in three-dimensional space (e.g., three translational degrees of freedom along Cartesian x, y, and z coordinates). As used herein, the term “orientation” refers to the rotational placement of an object or part of an object (e.g., one or more rotational degrees of freedom, such as roll, pitch, and yaw). As used herein, the term “pose” refers to the position of an object or part of an object in at least one translational degree of freedom and the orientation of the object or part of an object in at least one rotational degree of freedom (e.g., up to six total degrees of freedom). As used herein, the term “shape” refers to the set of poses, positions, and / or orientations measured along an object. As used herein, the term “distal” refers to a location closer to the procedural site, and the term “proximal” refers to a location further away from the procedural site. Thus, when an instrument is designed to perform a process, the distal portion or distal end of the instrument is closer to the procedural site than the proximal portion or proximal end of the instrument.

[0023] Embodiments of this disclosure include medical systems and methods for operating such medical systems. The medical system may be a medical system using flexible elongation devices (e.g., catheters, bronchoscopes, endoscopes, etc.), but may also be other medical systems.

[0024] A medical system may include a medical device, and the medical device may be driven along one or more axes of movement. In some embodiments, driving may involve movement of the medical device driven by an actuator along an insertion axis to move the medical device toward or away from a target tissue. Driving may occur when the medical system is operating in a first operating mode of the medical system. The first operating mode may be associated with, for example, navigation operations involving movement of the medical device toward a target tissue within an anatomical passage.

[0025] In some embodiments, the medical system can also operate in a second operating mode involving movement without actuator-driven movement of the medical device along the insertion axis. This second operating mode may be associated with, for example, medical procedures performed on target tissue. Medical procedures may include biopsy, ablation, electroporation, etc. The second operating mode may also be associated with a user's intention to apply an external force to the medical device, which could cause the medical device to move along the insertion axis.

[0026] In some embodiments, the medical system includes a brake that inhibits movement of the medical device along the insertion axis when the brake is engaged. In some embodiments, the brake can be engaged when the medical device is operating in a second operating mode. Embodiments of this disclosure relate to engaging the brake when a transition from a first operating mode to a second operating mode is detected, and releasing the brake when a transition from the second operating mode to the first operating mode is detected. The brake may remain engaged during the second operating mode and may remain released during the first operating mode. Although transitions between operating modes can be used to control the operation of the brake, a delay may exist between determining the time of the operating mode transition and initiating brake control to reduce brake overuse and avoid erroneous operating mode transition signals.

[0027] When the medical system is in a second operating mode, the engagement of the brake can suppress unintended reverse drive of the medical device caused by external forces. For example, various operations of the medical system can be triggered based on sensor-based detection of insertion or retraction of the medical device. These operations may be intended to trigger actuator-driven movement, but can also be unintendedly triggered by external forces causing insertion or retraction. In one example, the medical device may be a flexible elongation device (e.g., a catheter, bronchoscope, or endoscope) having an engageable body portion that relaxes upon retraction to prevent damage to the patient's anatomy. If an external force applied as part of a medical procedure (e.g., a biopsy) causes retraction, the flexible elongation device may relax unintendedly, potentially leading to loss of the intended pose used to perform the medical procedure. Therefore, suppressing unintended reverse drive of the medical device caused by external forces in the second operating mode can help avoid negative impacts on the medical procedure or impairment of the medical device's performance. Thus, embodiments of this disclosure rely on brakes in addition to servo-controlled actuators to jointly suppress unwanted and / or unintended movement of the medical device. Embodiments of this disclosure include a control system that smoothly engages and releases a brake during transitions between a first operating mode and a second operating mode, thereby avoiding interruptions to operations performed by a user operating the medical system. While the brake can be applied whenever there is no actuator-driven insertion or retraction, this practice can lead to excessive brake application, which reduces the lifespan of the brake and / or actuator. Therefore, the control system intelligently determines the transition between the first and second operating modes to apply the brake only when necessary. For example, the second operating mode may be associated with a system and / or process state that is unlikely to involve actuator-driven movement by the user and / or the user may apply external forces. A discussion of operations that may be performed in the second operating mode is provided below.

[0028] Various information, including sensor data and / or user input, can be used to determine changes in operating modes in order to control the actuator. This sensor data and / or user input can be used to programmatically determine the user's intention regarding actuator-driven movement of the medical device and / or the application of external forces on the medical device to switch between a first operating mode and a second operating mode.

[0029] The following, with reference to the accompanying drawings, provides a more detailed discussion of medical systems, medical devices, operating modes of medical systems, detection of transitions between operating modes, control of brakes based on the detection of transitions between operating modes, reverse drive, typical scenarios where reverse drive is more likely to occur, and possible consequences of reverse drive.

[0030] See attached image. Figure 1 This is a simplified diagram of a medical system 100 according to some embodiments. The medical system 100 can be applied to procedures such as surgery, diagnosis (e.g., biopsy), or treatment (e.g., ablation, electroporation, etc.). While some embodiments of such procedures are provided herein, any references to medical or surgical instruments and methods are non-limiting. The systems, instruments, and methods described herein can be used with animal or human cadavers, animal carcasses, parts of human or animal anatomy, for non-surgical diagnostics, and for industrial systems, general-purpose or special-purpose robotic systems, general-purpose or special-purpose remote operating systems, or robotic medical systems.

[0031] like Figure 1 As shown, the medical system 100 may include a manipulator assembly 102 that controls the operation of a medical device 104 during various procedures performed on a patient P. The medical device 104 may extend into an internal part of the patient P through an opening within the patient P. The manipulator assembly 102 may be a robot-assisted, non-assisted, or hybrid robot-assisted and non-assisted assembly having selectable degrees of freedom of motion that can be motorized and / or robot-assisted, and selectable degrees of freedom of motion that can be non-motorized and / or non-assisted. The manipulator assembly 102 may be mounted to and / or positioned near the patient table T. A master assembly 106 enables an operator O (e.g., a surgeon, clinician, internist, or other user) to control the manipulator assembly 102. In some examples, the master assembly 106 enables the operator O to view the procedure site or other graphical or information displays. In some examples, the manipulator assembly 102 may be excluded from the medical system 100, and the medical device 104 may be directly controlled by the operator O. In some examples, the manipulator assembly 102 may be manually controlled by the operator O. Direct operator control may include various handles and operator interfaces for handheld operation of medical device 104.

[0032] The main component 106 may be located at a surgeon's console near the patient table T where the patient P is located (e.g., in the same room as the patient table T), such as at the side of the patient table T. In some examples, the main component 106 is located away from the patient table T, such as in a different room or a different building. The main component 106 may include one or more control devices for controlling the manipulator component 102. The control devices may include any number of various input devices, such as joysticks, trackballs, rollers, steering pads, buttons, data gloves, trigger guns, manual controllers, voice recognition devices, motion or presence sensors, etc.

[0033] Manipulator assembly 102 supports medical device 104 and may include a kinematic structure of links providing a setting structure. Links may include one or more non-servo-controlled links (e.g., one or more links that can be manually positioned and locked in place) and / or one or more servo-controlled links (e.g., one or more links that can be controlled in response to commands, for example, from control system 112). Manipulator assembly 102 may include a plurality of actuators (e.g., motors) that drive inputs on medical device 104 in response to commands, for example, from control system 112. Actuators may include a drive system that moves medical device 104 in various ways when coupled to it. For example, one or more actuators may advance medical device 104 into a natural or surgically created anatomical opening. Actuators may control engagement of medical device 104, for example, by moving the distal end (or any other part) of medical device 104 in multiple degrees of freedom. These degrees of freedom may include three degrees of linear motion (e.g., linear motion along the X, Y, Z Cartesian axes) and three degrees of rotational motion (e.g., rotation about the X, Y, Z Cartesian axes). One or more actuators may control the rotation of the medical device about its longitudinal axis. The actuators may also be used to move the engageable end effector of the medical device 104 (e.g., to grasp tissue in the jaws of a biopsy device, etc.), or may be used to move or otherwise control tools inserted within the medical device 104 (e.g., imaging tools, ablation tools, biopsy tools, electroporation tools, etc.).

[0034] The medical system 100 may include a sensor system 108 having one or more subsystems for receiving information about the manipulator assembly 102 and / or the medical device 104. Such subsystems may include: a position sensor system (e.g., using an electromagnetic (EM) sensor or other type of sensor for detecting position or orientation); a shape sensor system for determining the position, orientation, rate, velocity, pose, and / or shape along one or more segments and / or distal ends of the flexible body of the medical device 104; a visualization system (e.g., using a color imaging device, infrared imaging device, ultrasound imaging device, X-ray imaging device, fluorescence imaging device, computed tomography (CT) imaging device, magnetic resonance imaging (MRI) imaging device, or some other type of imaging device) for capturing images, for example, from the distal end of the medical device 104 or from some other location; and / or an actuator position sensor (e.g., a resolver, encoder, potentiometer, etc.) describing the rotation and / or orientation of the actuator controlling the medical device 104.

[0035] The medical system 100 may include a display system 110 for displaying images or representations of the procedure site and the medical device 104. The display system 110 and the main component 106 may be oriented so that a physician O can use telepresent perception to control the medical device 104 and the main component 106.

[0036] In some embodiments, medical device 104 may include a visualization system that includes an image capture component that records simultaneous or real-time images of the procedure site and provides the images to an operator O via one or more displays of display system 110. The image capture component may include various types of imaging devices. The simultaneous images may be, for example, two-dimensional or three-dimensional images captured by an endoscope positioned within the anatomical procedure site. In some examples, the visualization system may include an endoscope component that may be integrally or removably coupled to medical device 104. Additionally or alternatively, a separate endoscope attached to a separate manipulator assembly may be used with medical device 104 to image the procedure site. The visualization system may be implemented as hardware, firmware, software, or a combination thereof that interacts with or is otherwise executed by one or more computer processors, such as control system 112.

[0037] Display system 110 can also display images of the process site and medical device, which can be captured by a visualization system. In some examples, medical system 100 provides operator O with a telepresented perception. For example, an image captured by an imaging device at the distal portion of medical device 104 can be presented by display system 110 to provide operator O with a perception of the distal portion of medical device 104. Inputs provided by operator O to master component 106 can move the distal portion of medical device 104 in a manner corresponding to the nature of the input (e.g., the distal end turns to the right when the trackball rolls to the right), and cause a corresponding change in the viewing angle of the image captured by the imaging device at the distal portion of medical device 104. Thus, operator O's telepresent perception is maintained when medical device 104 is moved using master component 106. Operator O can manipulate the hand controls of master component 106 and medical device 104 as if observing a workspace in a substantially real-world setting, simulating the experience of physically manipulating medical device 104 from within the patient's anatomy.

[0038] In some examples, the display system 110 may present virtual images of the procedure site created using image data recorded preoperatively (e.g., before the procedure performed by the medical device system 200) or intraoperatively (e.g., simultaneously with the procedure performed by the medical device system 200), such as image data created using computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET), fluoroscopy, thermal imaging, ultrasound, optical coherence tomography (OCT), thermal imaging, impedance imaging, laser imaging, nanotube X-ray imaging, etc. The virtual images may include two-dimensional, three-dimensional, or higher-dimensional images (e.g., including information based on time or rate). In some examples, one or more models are created based on the preoperative or intraoperative image dataset, and the virtual image is generated using one or more models.

[0039] In some examples, for the purpose of image-guided medical procedures, the display system 110 can display a virtual image generated based on the position of the tracking medical device 104. For example, the tracking position of the medical device 104 can be registered with a model generated using preoperative or intraoperative images (e.g., a dynamic reference), where different parts of the model correspond to different locations of the patient's anatomy. As the medical device 104 moves through the patient's anatomy, the registration is used to determine the parts of the model corresponding to the position and / or viewpoint of the medical device 104, and a virtual image is generated using the determined parts of the model. This presents the operator O with a virtual image of the internal process site corresponding to the tracking position of the medical device 104, based on the viewpoint of the medical device 104.

[0040] The medical system 100 may further include a control system 112, which may include processing circuitry to implement some or all of the methods or functions discussed herein. The control system 112 may include at least one memory and at least one processor for controlling the operation of the manipulator assembly 102, medical device 104, main assembly 106, sensor system 108, and / or display system 110. The control system 112 may include instructions (e.g., a non-transitory machine-readable medium storing instructions) that, when executed by at least one processor, configure one or more processors to implement some or all of the methods or functions discussed herein. Although the control system 112... Figure 1 While shown as a single block, control system 112 may include two or more separate data processing circuits, with some processing performed at manipulator component 102, others at main component 106, and so on. In some examples, control system 112 may include other types of processing circuitry systems, such as application-specific integrated circuits (ASICs) and / or field-programmable gate arrays (FPGAs). Control system 112 may be implemented using hardware, firmware, software, or a combination thereof.

[0041] In some examples, the control system 112 may receive feedback from the medical device 104, such as force and / or torque feedback. In response to this feedback, the control system 112 may transmit a signal to the main component 106. In some examples, the control system 112 may transmit a signal instructing one or more actuators of the manipulator component 102 to move the medical device 104. In some examples, the control system 112 may transmit information about the feedback to the display system 110 for presentation or to perform other types of actions based on the feedback.

[0042] Control system 112 may include a virtual visualization system to provide navigational assistance to operator O when controlling medical device 104 during image-guided medical procedures. Virtual navigation using the virtual visualization system may be based on a preoperative or intraoperative dataset of the acquired anatomical pathways of patient P. Control system 112 or a separate computing device may, alone or in combination with operator input, use programmed instructions to transform recorded images into a model of the patient's anatomy. This model may include a segmented two-dimensional or three-dimensional synthetic representation of parts or entire anatomical organs or regions. The image dataset may be associated with the synthetic representation. The virtual visualization system may obtain sensor data from sensor system 108 for calculating the (e.g., approximate) position of medical device 104 relative to the anatomical structures of patient P. Sensor system 108 may be used to register and display medical device 104 and images recorded preoperatively or intraoperatively. For example, PCT disclosure WO 2016 / 191298 (published December 1, 2016, entitled "Systems and Methods of Registration for Image Guided Surgery") discloses an example system, which is incorporated herein by reference in its entirety.

[0043] During the virtual navigation process, sensor system 108 can be used to calculate the (e.g., approximate) position of medical device 104 relative to the anatomical structure of patient P. This position can be used to generate both a macroscopic (e.g., external) tracking image of the anatomical structure of patient P and a virtual internal image of the anatomical structure of patient P. The system may include one or more electromagnetic (EM) sensors, fiber optic sensors, and / or other sensors to register and display the medical device and preoperatively recorded medical images. For example, U.S. Patent No. 8,900,131 (filed May 13, 2011, entitled “Medical System Providing Dynamic Registration of a Model of an Anatomic Structure for Image-Guided Surgery”), which is incorporated herein by reference in its entirety.

[0044] The medical system 100 may also include operating and support systems (not shown), such as lighting systems, steering and maneuvering control systems, irrigation systems, and / or suction systems. In some embodiments, the medical system 100 may include more than one manipulator assembly and / or more than one main assembly. The exact number of manipulator assemblies may depend on factors such as the medical procedure and space constraints within the operating room. Multiple main assemblies may be located in the same location or may be positioned in separate locations. Multiple main assemblies allow more than one operator to control one or more manipulator assemblies in various combinations.

[0045] Figure 2A This is a simplified diagram of a medical device system 200 according to some embodiments. The medical device system 200 includes a flexible elongation device 202 (also referred to as elongation device 202), a drive unit 204, and a flexible tool (e.g., a medical tool) 226, which together serve as an example of the medical device 104 of the medical system 100. The medical system 100 can be a remote operating system, a non-remote operating system, or a hybrid of remote and non-remote operating systems, as shown in reference... Figure 1 As described, the visualization system 231, tracking system 230, tool recognition sensor 233, and navigation system 232 are also included. Figure 2A The diagram shows an example component of the control system 112 of the medical system 100. In some examples, the medical device system 200 can be used in non-remotely operated exploration procedures or in procedures involving routine manual operation of medical devices (e.g., endoscopy). The medical device system 200 can be used to collect (e.g., measure) a set of data points corresponding to positions within the anatomical passage of a patient (e.g., patient P).

[0046] The elongation device 202 is coupled to the drive unit 204. The elongation device 202 includes a flexible tool (e.g., a medical instrument) 226 through which it can be inserted via a channel or lumen 221. The elongation device 202 navigates within the patient's anatomy to deliver the medical instrument 226 to the procedure site. The elongation device 202 includes a flexible body 216 having a proximal end 217 and a distal end 218. In some examples, the flexible body 216 may have an outer diameter of approximately 3 mm. Other flexible bodies may have larger or smaller outer diameters.

[0047] Medical device system 200 may include a tracking system 230 for determining the position, orientation, rate, velocity, pose, and / or shape of a flexible body 216 at its distal end 218 and / or along one or more segments 224 of the flexible body 216, as will be described in further detail below. Tracking system 230 may include one or more sensors and / or imaging devices. The flexible body 216 (e.g., the length between the distal end 218 and the proximal end 217) may include multiple segments 224. Tracking system 230 may be implemented using hardware, firmware, software, or a combination thereof. In some examples, tracking system 230 is... Figure 1 Part of the control system 112 shown.

[0048] Tracking system 230 can use shape sensor 222 to track the distal end 218 and / or one or more segments 224 of flexible body 216. Shape sensor 222 may include an optical fiber aligned with flexible body 216 (e.g., disposed within an internal channel of flexible body 216 or mounted externally along flexible body 216). In some examples, the optical fiber may have a diameter of about 200 μm. In other examples, the diameter may be larger or smaller. The optical fiber of shape sensor 222 can form an optical fiber bending sensor for determining the shape of flexible body 216. Optical fibers including fiber Bragg gratings (FBGs) can be used to provide strain measurements in one or more dimensions of the structure. Various systems and methods for monitoring the shape and relative position of optical fibers in three dimensions, applicable to some embodiments, are described in U.S. Patent Application Publication No. 2006 / 0013523 (filed July 13, 2005, entitled "Fiber optic position and shape sensing device and method relating thereto"), U.S. Patent No. 7,772,541 (filed March 12, 2008, entitled "Fiber Optic Position and / or Shape Sensing Based on Rayleigh Scatter"), and U.S. Patent No. 8,773,650 (filed September 2, 2010, entitled "Optical Position and / or Shape Sensing"), all of which are incorporated herein by reference in their entirety. In some embodiments, the sensor may employ other suitable strain sensing techniques, such as Rayleigh scattering, Raman scattering, Brillouin scattering, and fluorescence scattering.

[0049] In some examples, other techniques may be used to determine the shape of the flexible body 216. For example, the history of the position and / or pose of the distal end 218 of the flexible body 216 may be used to reconstruct the shape of the flexible body 216 over time intervals, such as when the flexible body 216 advances or retracts within a patient's anatomy. In some examples, the tracking system 230 may alternatively and / or additionally use a position sensor system 220 to track the distal end 218 of the flexible body 216. The position sensor system 220 may be a component of an EM sensor system, wherein the position sensor system 220 includes one or more position sensors. Although the position sensor system 220 is shown proximate to the distal end 218 of the flexible body 216 to track the distal end 218, the number and position of the position sensors in the position sensor system 220 may vary to track different regions along the flexible body 216. In one example, the position sensors include conductive coils that can withstand externally generated electromagnetic fields. Each coil of the position sensor system 220 may generate an induced electrical signal having characteristics that depend on the position and orientation of the coil in relation to the externally generated electromagnetic field. Position sensor system 220 can measure one or more position coordinates and / or one or more orientation angles associated with one or more portions of flexible body 216. In some examples, position sensor system 220 can be configured and positioned to measure six degrees of freedom, such as three position coordinates X, Y, Z and three orientation angles indicating pitch, yaw, and roll of a reference point. In some examples, position sensor system 220 can be configured and positioned to measure five degrees of freedom, such as three position coordinates X, Y, Z and two orientation angles indicating pitch and yaw of a reference point. Further description of the position sensor system applicable to some embodiments is provided in U.S. Patent No. 6,380,732 (filed August 11, 1999, entitled "Six-Degree of Freedom Tracking System Having a Passive Transponder on the Object Being Tracked"), which is incorporated herein by reference in its entirety.

[0050] In some implementations, the tracking system 230 may alternatively and / or additionally rely on a set of pose, position, and / or orientation data stored at points on the elongation device 202 and / or medical instrument 226, captured during one or more cycles of alternating movement (e.g., breathing). This stored data can be used to develop shape information about the flexible body 216. In some examples, a series of position sensors (not shown)—such as EM sensors like those in the position sensor system 220 or some other type of position sensor—can be positioned along the flexible body 216 and used for shape sensing. In some examples, a history of data acquired during the procedure from one or more of these position sensors can be used to represent the shape of the elongation device 202, particularly where the anatomical passage is typically static.

[0051] Figure 2B This is a simplified diagram of a flexible tool 226 within an elongation device 202 according to some embodiments. The flexible body 216 of the elongation device 202 may include a lumen 221 sized and shaped to receive the flexible tool 226. In some embodiments, the flexible tool 226 may be used in procedures such as diagnostics, imaging, surgery, biopsy, ablation, illumination, irrigation, aspiration, electroporation, etc. The flexible tool 226 can be deployed through the channels or lumen 221 of the flexible body 216 and operates at the procedure site within an anatomical structure. The flexible tool 226 may be, for example, an image capture probe, a biopsy tool (e.g., a needle, gripper, brush, etc.), an ablation tool (e.g., a laser ablation tool, a radiofrequency (RF) ablation tool, a cryoablation tool, a thermal ablation tool, a heated liquid ablation tool, etc.), an electroporation tool, and / or another surgical, diagnostic, or therapeutic tool. In some examples, the flexible tool 226 may include an end effector with a single working member, such as a scalpel, a blunt blade, an optical fiber, an electrode, etc. Other end effector types can include, for example, forceps, grippers, scissors, sutures, clamps, etc. Other end effectors can also include electrically activated end effectors, such as electrosurgical electrodes, transducers, sensors, etc.

[0052] The flexible tool 226 may be a biopsy tool for removing sample tissue or cells from a target anatomical location. In some examples, the biopsy tool is a flexible needle. The biopsy tool may also include a sheath that can surround the flexible needle to protect the needle and the inner surface of the lumen 221 when the biopsy tool is within the lumen 221. The flexible tool 226 may be an image capture probe that includes a distal portion having a stereo or single-field-of-view camera that can be positioned at or near the distal end 218 of the flexible body 216 for capturing images (e.g., still or video images). The captured images may be processed by a visualization system 231 for display and / or provided to a tracking system 230 to support tracking of the distal end 218 of the flexible body 216 and / or one or more segments 224 of the flexible body 216. The image capture probe may include a cable for transmitting the captured image data, which is coupled to an imaging device at the distal portion of the image capture probe. In some examples, the image capture probe may include a bundle of optical fibers, such as a fiber optic endoscope, coupled to a closer imaging device, such as the visualization system 231. The image capture probe may be monospectral or multispectral, capturing image data in one or more of the visible, near-infrared, infrared, and / or ultraviolet spectra. The image capture probe may also include one or more light emitters that provide illumination to facilitate image capture. In some examples, the image capture probe may use ultrasound, X-ray, fluoroscopy, CT, MRI, or other types of imaging techniques.

[0053] In some examples, an image capture probe is inserted within the flexible body 216 of the elongation device 202 to facilitate visual navigation of the elongation device 202 to the procedure site, and then the image capture probe is replaced within the flexible body 216 with another type of medical instrument 226 for performing the procedure. In some examples, the image capture probe may be located together with another type of flexible instrument 226 within the flexible body 216 of the elongation device 202 to facilitate simultaneous image capture and tissue intervention, for example, within the same lumen 221 or in different channels. The flexible instrument 226 may advance from the opening of the lumen 221 to perform the procedure (or some other function) and then retract into the lumen 221 upon completion of the procedure. The flexible instrument 226 may be removed from the proximal end 217 of the flexible body 216 or along the flexible body 216 from another optional instrument port (not shown).

[0054] Some implementations include a tool identification sensor 233, which can be used to detect the presence, insertion, and / or removal of a flexible tool 226 in the lumen 221. The tool identification sensor 233 can detect the presence, proximity, and / or absence of a target on the tool to detect the insertion signature of each inserted tool. Therefore, the tool identification sensor 233 can also be used to identify the tool type (e.g., needle, ablation tool, cutter, gripper, etc.), and based on the identification of the tool type, control mode alternation or tool behavior modification can be implemented.

[0055] Tool identification sensor 233 may include one or more target readers (not shown) configured to detect one or more targets on a tool and / or catheter. Tool identification sensor 233 may include inductive sensors (e.g., inductors or induction coils that detect changes in inductance caused by the ferromagnetic and conductive properties of a material), capacitive sensors, Hall effect sensors, photogate sensors, optical sensors, magnetic switches, barcode scanners, radio frequency identification (RFID) scanners, relative position sensors, or combinations thereof, capable of reading one or more corresponding targets on a tool to be inserted into lumen 221. Any combination of different types of target readers may be implemented in tool identification sensor 233. PCT disclosure WO 2020 / 014207 (published January 16, 2020, entitled “Systems for Sensing Presence of Medical Tools”) discloses an example system including a tool identification sensor, which is incorporated herein by reference in its entirety.

[0056] Some implementations include a force sensor 234. The force sensor 234 can be used to indirectly detect the insertion or removal of the flexible tool 226 based on the external force involved in the insertion or removal. The force sensor 234 can also detect external forces unrelated to the insertion or removal of the flexible tool. Such external forces may be caused by touch, accidental impact, etc. The force sensor 234 can be located at a position where it can sense external forces associated with the insertion or removal of the flexible tool. In some implementations, the force sensor is mounted on an instrument holder (see below). Figure 3A and 3B (As described above), and thus can detect any external forces applied to the instrument holder or components attached to the instrument holder. Force sensor 234 may be able to resolve external forces in different directions (e.g., in the insertion and retraction directions). In some embodiments, force sensor 234 may be located elsewhere, such as on the flexible elongation device 202.

[0057] In some examples, the extension device 202 may include integrated imaging capabilities instead of utilizing a removable image capture probe. For example, the imaging device (or fiber bundle) and light emitter may be located at the distal end 218 of the extension device 202. The flexible body 215 may include one or more dedicated channels carrying cables and / or optical fibers between the distal end 218 and the visualization system 231. Here, the medical device system 200 can perform imaging and tooling operations simultaneously.

[0058] In some examples, the medical tool 226 is capable of controlled engagement. The medical tool 226 may house a cable (also referred to as a traction cable), linkage, or other actuation controls (not shown), extending between its proximal and distal ends to controllably bend the distal end of the medical tool 226, such as those discussed herein with respect to the flexible elongation device 202. The medical tool 226 may be coupled to the drive unit 204 and the manipulator assembly 102. In these examples, the elongation device 202 may be excluded from the medical device system 200, or may be a flexible device without controlled engagement. Steering maneuvers or instruments applicable to some embodiments are further described in detail in U.S. Patent No. 7,316,681 (filed October 4, 2005, entitled "Articulated Surgical Instrument for Performing Minimally Invasive Surgery with Enhanced Dexterity and Sensitivity") and U.S. Patent No. 9,259,274 (filed September 30, 2008, entitled "Passive Preload and Capstan Drive for Surgical Instruments"), which are incorporated herein by reference in their entirety.

[0059] The flexible body 216 of the elongation device 202 may also, or alternatively, be accommodated between the drive unit 204 and the distal end 218 to controllably bend the distal end 218 (e.g., by means of...). Figure 2AThe distal end 218 (shown as dashed line 219) is connected to cables, linkages, or other steering control mechanisms (not shown). In some examples, at least four cables are used to provide independent up-and-down steering control to control the pitch of the distal end 218 and left-and-right steering control to control the yaw of the distal end 281. In these examples, the flexible elongation device 202 may be a steerable conduit. Examples of steerable conduits suitable for some embodiments are described in detail in PCT Publication WO 2019 / 018736 (published January 24, 2019, entitled "Flexible Elongate Device Systems and Methods"), which is incorporated herein by reference in its entirety.

[0060] In embodiments where the elongation device 202 and / or medical tool 226 is actuated by a remotely operated component (e.g., manipulator component 102), the drive unit 204 may include a drive input removably coupled to and receiving power from a drive element (e.g., an actuator) of the remotely operated component. The drive unit 204 may also include a brake. A brake may be paired with an actuator. In a configuration where the actuator is paired with a gear reducer, the brake may be located on the actuator side, allowing even a relatively small brake to produce significant braking force. In some examples, the elongation device 202 and / or medical tool 226 may include a gripping feature, a manual actuator, or other components for manually controlling the movement of the elongation device 202 and / or medical tool 226. The elongation device 202 may be steerable, or alternatively, it may be non-steerable, without an integrated mechanism for operator control of bending of the distal end 218. In some examples, one or more channels 221 (which may also be referred to as lumens) may be defined by the inner wall of the flexible body 216 of the elongation device 202, through which the medical tool 226 may be deployed and used at a target anatomical location.

[0061] In some examples, medical device system 200 (e.g., extension device 202 or medical tool 226) may include flexible bronchial instruments, such as bronchoscopes or bronchial tubes, for the examination, diagnosis, biopsy, and / or treatment of the lungs. Medical device system 200 may also be adapted to navigate and treat other tissues within any anatomical system of a variety of anatomical systems via naturally or surgically generated access channels, including the colon, intestine, kidneys and renal calyces, brain, heart, circulatory system including the vascular system, etc.

[0062] Information from tracking system 230 can be sent to navigation system 232, where it can be combined with information from visualization system 231 and / or a preoperatively acquired model to provide real-time location information to physicians, clinicians, surgeons, or other operators. In some examples, the real-time location information can be displayed on display system 110 for controlling medical device system 200. In some examples, navigation system 232 can utilize the location information as feedback for locating medical device system 200. Various systems for registering and displaying surgical instruments and surgical images using fiber optic sensors, applicable to some embodiments, are provided in U.S. Patent No. 8,900,131 (filed May 13, 2011, entitled “Medical System Providing Dynamic Registration of a Model of an Anatomic Structure for Image-Guided Surgery”), which is incorporated herein by reference in its entirety.

[0063] Figure 2C A manipulator assembly 102, including an instrument manipulator 206 coupled to a support structure 298, is shown according to some embodiments of the present disclosure. Links in the support structure 298 may include one or more non-servo-controlled links (e.g., those that can be manually positioned and locked in place) and / or one or more servo-controlled links (e.g., powered links that can be controlled in response to commands from a control system). The support structure 298 provides adjustments to position the instrument manipulator 206 in an optimal location and orientation and / or to position the flexible extension device 202 relative to a patient's anatomy or other medical device. For example, the support structure 298 may provide rotation E1 about axis E, extension / retraction E2 along axis E, rotation D1 about axis D, and rotation C1 about axis C and rotation B1 about axis B to position the instrument manipulator 206 relative to a worktable (not shown), a medical device (not shown), and / or a patient (not shown) in a desired position.

[0064] In some embodiments, optimal positioning and orientation may include alignment of the instrument manipulator 206 relative to the patient's anatomy, such as optimal positioning of the flexible elongation device (202) to minimize friction of the flexible elongation device (202) located within or coupled to the patient's anatomy (e.g., anatomical openings, the patient's vascular system, intracavitary passages, etc.) or medical devices (e.g., cannulas, cannula needles, endotracheal tubes (ETTs), laryngeal esophageal masks (LMAs), etc.). In other embodiments, optimal positioning and orientation of the instrument manipulator 206 may additionally or alternatively include optimizing operator ergonomics by providing sufficient operator workspace and / or ergonomic access to the flexible elongation device 202 when using various medical tools (e.g., needles, grippers, scalpels, clamps, ablation probes, visualization probes, etc.) via the flexible elongation device 202.

[0065] The instrument manipulator 206 can also be configured to provide remote operation, robotic control, or other forms of controlled or manual translation A1 along axis A to provide insertion and retraction of the flexible elongation device 202 relative to the patient's anatomy.

[0066] Each adjustment (e.g., A1, B1, C1, D1, E1, and E2) can be actuated by an actuator that can be combined with a brake. Figure 2D Examples are provided in the document.

[0067] Figure 2D A cross-sectional view of an actuator-brake assembly according to some embodiments is shown. In the example, actuator-brake assembly 270 is used to control the insertion and retraction of flexible elongation device 202, for example, along axis A. Similar actuator-brake assemblies can be used to control other degrees of freedom (e.g., along axes B, C, D, and / or E).

[0068] The actuator-brake assembly 270 includes a motor 272 and a brake 280. The motor can be any type of motor, such as a brushless DC motor with a motor stator 274 and a motor rotor 276. The brake 280 is an electromagnetically controllable brake equipped with a brake coil 282, a brake pressure plate 284, and a brake armature 286. The brake armature 286 can be released by electrically driving the brake coil 282, which causes the brake pressure plate 284 to lift. Other brake designs can be used without departing from this disclosure.

[0069] Figure 3A and Figure 3B This is a simplified side view of a medical device mounted on an insertion assembly, according to some embodiments, in patient coordinate space. Figure 3A and Figure 3BAs shown, the surgical environment 300 may include a patient P positioned on a patient table T. Patient P may be stationary within the surgical environment 300 because overall patient movement is restricted by sedation, restraint, and / or other means. Periodic anatomical movements of patient P (including respiratory and cardiac movements) may continue. Within the surgical environment 300, a medical device 304 is used to perform medical procedures, which may include, for example, surgery, biopsy, ablation, illumination, irrigation, aspiration, or electroporation. The medical device 304 may also be used to perform other types of procedures, such as a registration process that associates position, orientation, and / or pose data captured by a sensor system 108 with a desired (e.g., anatomical or systemic) reference frame. The medical device 304 may be, for example, medical device 104. In some examples, the medical device 304 may include an elongation device 310 (e.g., a catheter) coupled to an instrument body 312. The elongation device 310 includes one or more channels sized and shaped to receive medical instruments.

[0070] The elongation device 310 may also include one or more sensors (e.g., components of sensor system 108). In some examples, a shape sensor 314 may be fixed at a proximal point 316 on the instrument body 312. The proximal point 316 of the shape sensor 314 may move with the instrument body 312, and the position of the proximal point 316 relative to a desired reference frame may be known (e.g., via a tracking sensor or other tracking device). The shape sensor 314 may measure the shape from the proximal point 316 to another point (e.g., the distal end 318 of the elongation device 310). The shape sensor 314 may be aligned with the elongation device 310 (e.g., disposed within an internal channel or mounted externally). In some examples, the shape sensor 314 may be an optical fiber used to generate shape information of the elongation device 310.

[0071] In some examples, position sensors (e.g., EM sensors) may be incorporated into medical device 304. A series of position sensors may be positioned along the flexible elongation device 310 and used for shape sensing. Position sensors may be used in place of or in conjunction with shape sensor 314, for example, to improve the accuracy of shape sensing or to verify shape information.

[0072] The extension device 310 may accommodate cables, linkages, or other steering control mechanisms that extend between the instrument body 312 and the distal end 318 to controllably bend the distal end 318. In some examples, at least four cables are used to provide independent up-and-down steering control to control the pitch of the distal end 318 and left-and-right steering control to control the yaw of the distal end 318. The instrument body 312 may include a drive input that is removably coupled to and receives power from a drive element (e.g., an actuator) of the manipulator assembly.

[0073] The instrument body 312 may be coupled to the instrument holder 306. The instrument holder 306 may be mounted to an insertion stage 308 fixed within the surgical environment 300. Alternatively, the insertion stage 308 may be movable but has a known position within the surgical environment 300 (e.g., via a tracking sensor or other tracking device). The instrument holder 306 may be a component of a manipulator assembly (e.g., manipulator assembly 102) coupled to the medical device 304 to control movement of the distal end 318 of the extension device 310 in multiple directions (e.g., yaw, pitch, and / or roll) and / or insertion movement (e.g., movement along the insertion axis A). The instrument holder 306 or the insertion stage 308 may include an actuator, such as a servo motor, for controlling movement of the instrument holder 306 along the insertion stage 308. The instrument holder 306 or the insertion stage 308 may also include a brake. A brake may be paired with an actuator. For example, an actuator may be provided for driving the medical device along the insertion axis of the manipulator assembly, and a brake may be provided for inhibiting the movement of the medical device along the insertion axis.

[0074] Sensor device 320 (which may be a component of sensor system 108) can provide information about the position of instrument body 312 as it moves relative to insertion stage 308 along insertion axis A. Sensor device 320 may include one or more rotary transformers, encoders, potentiometers, and / or other sensors that measure the rotation and / or orientation of actuators controlling the movement of instrument carriage 306, thereby indicating the movement of instrument body 312. In some embodiments, insertion stage 308 has, for example, […]. Figure 3A and Figure 3B The linear track is shown. In some embodiments, the insertion stage 308 may have a curved track or a combination of curved track segments and linear track segments.

[0075] Figure 3A The instrument body 312 and instrument holder 306 are shown in the retracted position along the insertion stage 308. In this retracted position, the proximal point 316 is located at position L0 on the insertion axis A. The position of the proximal point 316 can be set to zero and / or other reference values ​​to provide a basic reference (e.g., corresponding to the origin of the desired reference system) to describe the position of the instrument holder 306 along the insertion stage 308. In the retracted position, the distal end 318 of the extension device 310 can be positioned precisely within the inlet orifice of the patient P. Also in the retracted position, data captured by the sensor device 320 can be set to zero and / or other reference values ​​(e.g., I=0). Figure 3BIn this configuration, the instrument body 312 and instrument holder 306 have advanced along the linear track of the insertion stage 308, and the distal end 318 of the elongation device 310 has advanced into the patient P. At this advanced position, the proximal point 316 is located at position L1 on the insertion axis A. In some examples, rotation and / or orientation of the actuator measured by the sensor device 320 indicating the movement of the instrument holder 306 along the insertion stage 308 and / or by one or more position sensors associated with the instrument holder 306 and / or the insertion stage 308 can be used to determine the position L1 of the proximal point 316 relative to position L0. In some examples, position L1 can also serve as an indicator of the distance or insertion depth of the distal end 318 of the elongation device 310 inserted into the channel of the anatomical structure of the patient P.

[0076] Figure 4 This is a simplified perspective view of an input console 400 according to some embodiments. The input console 400 may correspond to or be part of the main component 106. The top surface 410 of the input console 400 includes various input controls, such as, for example, insert / retract controls 440, passive control buttons 450, steering control controls 460, and emergency stop buttons 470. The input console may also include an integrated display screen (e.g., screen 420). Although... Figure 4 Various configurations of input controls are shown for the elongation device; however, it should be understood that the input console 400 can control any type of instrument and device, and the exact placement, orientation, relative positioning, etc., of the various input controls are merely exemplary. It should be understood that other configurations of input controls, different numbers of input controls, etc., are possible. In some embodiments, the input console 400 is suitable as a patient-side input control unit for the elongation device and may, for example, be mounted near the insertion stage 308.

[0077] although Figure 4Not shown, but the input console 400 may optionally include one or more circuit boards, logic boards, etc., for providing power, signal conditioning, interface, and / or other circuitry to the input console 400. In some examples, one or more circuit boards, logic boards, etc., may be used to interface the input console 400 and its various input controls with the control unit of the extension device. In some examples, the control unit of the extension device corresponds to the control device of the main component 106, the control system 112, etc. In some examples, one or more circuit boards, logic boards, etc., may include memory and one or more processors, multi-core processors, field-programmable gate arrays (FPGAs), application-specific integrated circuits (ASICs), etc. In some examples, the memory may include one or more types of machine-readable media. Some common forms of machine-readable media may include floppy disks, flexible disks, hard disks, magnetic tapes, any other magnetic media, CD-ROMs, any other optical media, RAM, PROMs, EPROMs, FLASH-EPROMs, any other memory chips or cassette tapes, and / or any other media that a processor or computer is adapted to read from.

[0078] In some examples, the insertion / retraction control 440 is a single-degree-of-freedom infinite-travel input control providing an infinite length of travel along a first axis, which can be used by the operator to control the insertion depth of the distal end of the extension device. The insertion / retraction control 440 is depicted as a roller; however, other types of input controls, including non-infinite-travel input controls, are also possible. In some examples, rolling the roller forward away from the operator increases the insertion depth (insertion) of the distal end of the extension device, and rolling the roller backward toward the operator decreases the insertion depth (retraction) of the distal end of the extension device. In some examples, the insertion / retraction control 440 can be used by the operator to move the instrument holder 306 in and out along the insertion table 308 to control the insertion depth of the distal end 318.

[0079] When the insertion / retraction control 440 is an infinite-travel input control, operating the insertion / retraction control 440 in position-specified mode allows the operator to precisely control the insertion depth of the distal end of the extension device throughout its entire travel. In some examples, the movement of the insertion / retraction control 440 can be detected by one or more circuit boards, logic boards, etc., of the input console 400 using one or more encoders, resolvers, optical sensors, Hall effect sensors, etc. (not shown). In some examples, feedback applied via one or more electromagnetic actuators, etc., can optionally be used to apply tactile feedback to the insertion / retraction control 440. In some examples, the scaling factor between the amount of movement of the insertion / retraction control 440 and the amount of insertion and / or retraction movement of the extension device can be adjusted by the operator and / or the control software of the extension device, allowing the insertion / retraction speed of the extension device relative to the angular velocity of the insertion / retraction control to allow for both fast insertion and retraction when advantageous, and slower, more precise insertion and retraction when higher control precision is desired.

[0080] In some examples, the steering control 460 is a multi-degree-of-freedom infinite-travel input control providing infinite travel about any number of axes, which in practice can be decomposed into combinations of left and right rotation, forward and backward rotation, and rotation in place. The steering control 460 is depicted as a trackball; however, other types of input controls, including non-infinite-travel input controls, are also possible. The steering control 460 can be used by the operator to simultaneously control both pitch and yaw at the distal end of the extension device. In some examples, the rotational components of the trackball in the forward and backward directions can be used to control the pitch of the distal end of the extension device, and the rotational components of the trackball in the left and right directions can be used to control the yaw of the distal end of the extension device. In some examples, other rotational components of the trackball can be used to control pitch and / or yaw, where the operator can optionally control the direction of rotation to be normal and / or reverse relative to the direction applied to the steering control (e.g., forward rotation to pitch down and backward rotation to pitch up relative to backward rotation to pitch down and forward rotation to pitch up). In some examples, the steering control 460 can be used by an operator to manipulate the distance each of the cables extending between the proximal and distal ends of the extension device is pushed and / or pulled.

[0081] In some implementations, the insertion / retraction control 440 and / or steering control 460 include touch sensors. The touch sensors may be capacitive touch sensors or any other type of touch sensor. Alternatively or additionally, pressure sensors may be included. The touch and / or pressure sensors at the input console 400 can be used to distinguish between intended movement by the operator and unintentional movement caused by accidental contact, dropping of the input console 400, etc. Other types of proximity sensors (e.g., ultrasonic sensors, visual sensors, light walls, etc.) can be used to detect operator proximity to the input controls. In some examples, one or more wrist detection sensors (e.g., capacitive touch sensors, pressure sensors, and / or similar sensors) on the wrist rest can be used to detect operator proximity to the input controls.

[0082] Figure 5 This is an illustration of the operating modes of a medical system according to some embodiments. The example shows two different operating modes—a first operating mode 510 and a second operating mode 520. A first transition 530 enables the medical system to switch from operating in the first operating mode 510 to the second operating mode 520, and a second transition 540 enables the medical system to switch from operating in the second operating mode 520 back to the first operating mode 510. The medical system may have any number of operating modes without departing from this disclosure. The first operating mode, the second operating mode, the first transition, and the second transition will be discussed subsequently.

[0083] The first operating mode 510 can be used for operations involving actuator-driven movement of the medical device along a movement axis (e.g., along the insertion axis) to move the medical device toward or away from a target tissue. For example, the first operating mode can be used when performing navigation operations. For example, a controller based on a servo control loop can control the position and / or speed of an actuator that causes movement of the medical device along the movement axis. The controller can receive commanded position and / or speed and can cause movement based on the commanded position and / or speed. In the example of controlling movement along the insertion axis, a user can operate the insertion / retraction control 440 to provide a commanded position and / or speed, thereby causing a corresponding movement along the insertion axis by the servo actuator following the commanded position and / or speed. As previously discussed, the actuator can be equipped with a brake. When in the first operating mode 510, the brake is controlled to release, thereby allowing actuator-driven movement of the medical device along the movement axis.

[0084] The second operating mode 520 can be used for actively driven operations that do not involve actuators to cause movement of a medical device along a movement axis. For example, the second operating mode can be used when performing medical procedures on target tissue (e.g., one or more of biopsy, ablation, electroporation, etc.). When in the second operating mode 520, a controller that controls the position and / or speed of the actuator can be configured to maintain the current position, for example, by commanding a constant position and / or zero speed. The second operating mode can be associated with system and / or process states that are unlikely to be intended by the user to be actuator-driven and / or where the user may apply external forces.

[0085] An actuator can generate a limited force or torque when controlled to maintain its current position. Therefore, an externally applied force or torque, if high enough, may cause the actuator to reverse, even when the actuator is servo-driven to maintain its current position. See [reference to...] Figure 2A , Figure 2B , Figure 2C , Figure 2D , Figure 3A and Figure 3B In the configuration shown, when a user interacts with the medical system, the reverse drive of the medical device 304 along the insertion axis can occur in various situations, such as when inserting and / or mounting the flexible tool 226 (e.g., an image capture probe, biopsy tool, etc.) or accidentally contacting the instrument body 312, etc. Such reverse drive causes movement of the elongation device 310. For example, when a force is applied in the insertion direction, the elongation device 310 may move slightly in the insertion direction. When the force is no longer applied, a servo-controlled actuator can compensate for the reverse drive and return the actuator to its initially held position. This causes the flexible elongation device 310 to move in the retraction direction, returning to the initial insertion depth. In another example, when a force is applied in the retraction direction, the flexible elongation device 310 may move slightly in the retraction direction. When the force is no longer applied, a servo-controlled actuator can compensate for the reverse drive and return the actuator to its initially held position. However, this does not necessarily cause the flexible elongation device 310 to return to the initial insertion depth. Conversely, due to the flexibility of the flexible elongation device 310, it may relax and fail to return fully or not at all to its initial insertion depth. If the system is configured to perform various operations based on detected insertion or retraction of the flexible elongation device 310, insertion or retraction caused by external forces may result in unintended execution of such operations. An example of such an operation is relaxation during retraction, where the force exerted by the traction wires within the flexible elongation device 310 decreases, allowing the engageable body portion of the flexible elongation device 310 to lose its orientation and / or become more compliant with external forces within the anatomical structure.

[0086] In the second operating mode 520, the brake is controlled (e.g., engaged or otherwise applied) to suppress movement of the medical device along the axis of motion (e.g., caused by an external force). The application of the brake can reduce or eliminate possible reverse drive in the previously described scenarios. The actuator's servo can continue while the brake is applied, such that the brake and servo together counteract the reverse drive. In the first operating mode 510, the brake is controlled (e.g., released or otherwise not applied) to allow actuator-driven movement of the medical device along the axis of motion.

[0087] While the above discussion captures the first operating mode 510 and the second operating mode 520 within the context of the insertion axis, embodiments of this disclosure are applicable to any other moving axis. For example, the moving axis may include the engagement axis of a flexible extension device (e.g., pitch or yaw) or some other moving axis of a flexible extension device or medical instrument.

[0088] Then refer to Figure 6 The flowchart describes the transition between a first operating mode and a second operating mode (including the engagement and release of the brake). In some embodiments, the engagement or release of the brake against the axis of motion can be triggered based on the transition between the first and second operating modes.

[0089] Figure 6 A flowchart of a method 600 for conditionally engaging a brake to suppress reverse drive of a medical device, according to an embodiment of the present disclosure, is shown. At a high level, method 600 can be used to engage the brake when a user is expected to operate the medical device in a second operating mode. The method can also be used to release the brake when a user is expected to operate the medical device in a first operating mode.

[0090] This method can be implemented using instructions stored on a non-transient medium, which can be executed by a computing system (e.g., computing system 120).

[0091] Although Figure 6 The various blocks in the code are presented and described sequentially, but some or all of the blocks can be executed in a different order, can be combined or omitted, and some or all of the blocks can be executed in parallel. Furthermore, the blocks can be executed actively or passively.

[0092] For the purposes of discussing the flowchart, let's assume the healthcare system is initially in a first operating mode. This allows for the initial transition from the first operating mode to the second operating mode. Alternatively, the healthcare system could initially be in a second operating mode. In this case, the initial transition could be from the second operating mode to the first operating mode.

[0093] In block 610, it is determined that the medical system is in a second operating mode. This second operating mode may have already been reached or can be reached through a first transition from the first operating mode to the second operating mode. In many cases, whether the medical system operates in the first or second operating mode can be based on user intent. In one example, the user can provide user input that directly instructs the medical system whether it should operate in the first or second operating mode. However, in other examples, sensor data from one or more sensors or other types of user input for operating the medical system can be used to programmatically determine user intent regarding operating modes or transitions between operating modes. This allows the user to use the medical system seamlessly without having to spend time or mental / physical resources selecting an operating mode, while still providing the benefits of mode-based braking discussed herein. Therefore, various factors can indicate whether the medical system should operate in the first or second operating mode. Embodiments of this disclosure take these factors into account in determining the first transition, as described below.

[0094] In some implementations, determining whether the medical system is in a first operating mode (e.g., involving movement of the medical device driven by an actuator along the insertion axis and / or no external force applied to the medical device) or a second operating mode (e.g., involving no movement of the medical device driven by an actuator along the insertion axis and / or no external force applied to the medical device) can be performed, which may involve determining the transition between the first and second operating modes.

[0095] Operation in the second operating mode can be determined based on sensor data obtained from sensors in the medical system. Various sensors can be used to determine if the user intends to drive the instrument along the insertion axis.

[0096] In some embodiments, touch sensors, pressure sensors, or proximity sensors may be used to detect the presence or absence of a user's hand on or near the input device used to control the medical device along the insertion axis. In some embodiments, the operation of the user's input device (e.g., the operation of a scroll wheel) may be monitored for detection. Other sensors may be used without departing from this disclosure.

[0097] Detecting the absence of a user's hand at or near the input device can serve as an indication that the user does not intend to drive the medical device along the insertion axis in the near future. Therefore, when the sensor detects the absence of touch, proximity, and / or user input for at least a pre-specified time interval (e.g., 5 seconds), operation of the medical system in a second operating mode can be determined.

[0098] In some implementations, tool identification sensors can be used to detect the presence or absence of a tool in a medical device. This tool can be a visual probe (e.g., an endoscopic camera device) or a tool used to perform procedures (e.g., biopsy, ablation, electroporation, etc.).

[0099] A vision probe can be used to obtain visual feedback during navigation operations when driving the medical device along the insertion axis. Therefore, the absence of the vision probe can serve as an indication that the user does not intend to drive the medical device along the insertion axis. Thus, when the tool recognition sensor detects the removal of the vision probe, the operation of the medical system in a second operating mode can be determined.

[0100] The tool used to perform the procedure benefits from a mechanically stable operating environment. Therefore, the use of such a tool can serve as an indication that the user does not intend to drive the medical device along the insertion axis. Thus, when the tool identification sensor detects the insertion of the tool for performing the procedure, operation of the medical system in a second operating mode can be determined. In some embodiments, the type of tool is considered when determining the operating mode. For a first type of tool, a second operating mode is determined. A biopsy needle is an example of a first type of tool that benefits from engagement brakes. For a second type of tool, a second operating mode is not determined. Tweezers are an example of a second type of tool that does not require engagement of a brake.

[0101] In some implementations, force sensors can be used to detect the presence of external forces that may cause movement of the medical device along the insertion axis. Such external forces may be associated with the insertion or removal of the tool, or with contact, collision, etc. External forces can also be detected based on control errors associated with the actuator when the device is actuated. For example, control errors can be detected by comparing the actual position of the actuator (e.g., obtained from an encoder) with the desired position of the actuator. To prevent unintended movement along the insertion axis in the presence of external forces, the operation of the medical system in a second operating mode can be determined.

[0102] In some implementations, the proximity of the medical device to a target (e.g., target tissue) is used to determine the second operating mode. Specifically, after performing registration as previously described and using sensors of the medical system to track the position of the medical device, the distance of the medical device from the target can be determined. Once a certain proximity is reached, the medical device can be used to perform an actual medical procedure. Therefore, once a certain proximity is reached, the second operating mode can be determined.

[0103] In some implementations, the second operating mode can be determined based on a user request. For example, the user can provide control inputs that explicitly specify the system will operate in the second operating mode.

[0104] In block 620, based on the determination that the medical system is in a second operating mode, the brake is engaged to suppress movement of the medical device along the insertion axis caused by external forces. While the brake is engaged, the actuator can still be servo-driven in its current position. Therefore, the brake and the servo-controlled actuator together counteract any actual or potential reverse drive.

[0105] In block 630, it is determined that the medical system is operating in a first operating mode. The first operating mode may have been reached or can be reached through a second transition from a second operating mode to the first operating mode.

[0106] In some implementations, the determination of the medical system being in a first operating mode (involving movement of the medical device driven by an actuator along the insertion axis) can be performed as follows.

[0107] The first operating mode can be determined based on sensor data obtained from sensors in the medical system. Various sensors can be used to determine the user's intention to drive the instrument along the insertion axis.

[0108] As previously described, in some embodiments, touch sensors, pressure sensors, proximity sensors and / or other sensors may be used to detect whether a user’s hand is present or absent on or near the input device used to control the medical device along the insertion axis.

[0109] The detection of a user's hand at or near the input device can serve as an indication that the user intends to drive the medical device along the insertion axis in the near future. Therefore, a first operating mode can be determined when the sensor detects the presence of touch, proximity, and / or user input. This detection can trigger the determination of the first operating mode immediately, without delay. Furthermore, this detection can override other potentially contradictory detections. For example, while the absence of the visual probe observed in isolation could serve as an indication that the user does not intend to drive the medical device along the insertion axis, detecting the user's hand at or near the input device will cause the determination of the first operating mode to ensure the responsiveness of the medical system to user input, even in the absence of the visual probe.

[0110] As previously discussed, in some implementations, tool identification sensors can be used to detect the presence or absence of a tool in a medical device. This tool can be a visual probe (e.g., an endoscopic camera device) or a tool used to perform procedures (e.g., biopsy, ablation, electroporation, etc.).

[0111] A vision probe can be used to obtain visual feedback during navigation operations, when driving the medical device along the insertion axis. Therefore, the presence of the vision probe can serve as an indication of the user's intention to drive the medical device along the insertion axis. Thus, when the tool recognition sensor detects the insertion of the vision probe, a first operating mode can be determined.

[0112] The tool used to perform the procedure benefits from a mechanically stable operating environment. Tool removal may indicate a user's intention to drive the medical device along the insertion axis, for example, to move it from one target site to another. Therefore, when the tool recognition sensor detects the removal of the tool used to perform the procedure, a first operating mode can be determined.

[0113] In some implementations, the first operating mode can be determined based on a user request. For example, the user can provide control inputs that explicitly specify the system will operate in the first operating mode.

[0114] In block 640, based on the determination that the medical system is in a first operating mode, the brake is released to allow the medical device to move along the insertion axis.

[0115] Method 600 can be executed in a loop capable of repeatedly switching between a first operating mode and a second operating mode. The medical system can remain in either the first or second operating mode for any amount of time until a first or second switch occurs. However, by monitoring the current state as described above, the engagement and release of the brake are not directly related to the actual absence or presence of actuator-driven movement (which could lead to frequent and excessive engagement and release of the brake). Instead, based on the described operation, the absence of drive and drive in the foreseeable future is predicted as a state, thereby limiting the cycle of brake engagement and release to a lower frequency while ensuring that spontaneous actuation is possible when needed. Furthermore, while several factors that can determine operation in the first and second operating modes have been discussed, other factors can also be considered. For example, the possibility of undesirable reverse drive may be influenced by actuator size, mechanical design, and / or current mechanical or kinematic configuration. Specifically, for example, if reverse drive occurs in a non-horizontal direction, gravity can further increase the possibility of reverse drive based solely on the additional weight that needs to be supported by the servoed actuator. Therefore, when the insertion axis is in a vertical or non-horizontal direction, the engagement of the brake may be required to avoid reverse drive, but when the insertion axis is in a horizontal direction, the engagement of the brake may not be required to avoid reverse drive.

[0116] Although method 600 is described in the context of an insertion axis, the method is equally applicable to other moving axes. For example, the method can be applied to a manipulator arm with multiple joints, where both insertion and lifting can be adjusted during the actuation of a flexible extension device in the insertion / retraction direction.

[0117] One or more components of the embodiments discussed in this disclosure (e.g., control system 112) may be implemented in software to execute on one or more processors of a computer system. The software may include code that, when executed by one or more processors, configures the processors to perform the various functions discussed herein. The code may be stored in a non-transitory computer-readable storage medium (e.g., memory, magnetic storage device, optical storage device, solid-state storage device, etc.). The computer-readable storage medium may be part of a computer-readable storage device, such as electronic circuitry, a semiconductor device, a semiconductor memory device, a read-only memory (ROM), flash memory, an erasable programmable read-only memory (EPROM), a floppy disk, a CD-ROM, an optical disk, a hard disk, or other storage device. The code may be downloaded to the computer-readable storage medium for storage via a computer network such as the Internet, an intranet, etc. The code may be executed by any of a variety of centralized or distributed data processing architectures. The programming instructions of the code may be implemented as multiple separate programs or subroutines, or they may be integrated into multiple other aspects of the system described herein. Components of the computing system discussed herein may be connected using wired and / or wireless connections. In some examples, wireless connectivity can use wireless communication protocols such as Bluetooth, Near Field Communication (NFC), Infrared Data Association (IrDA), Home RF, IEEE 802.11, Digital Enhanced Cordless Telecommunications (DECT), and Wireless Medical Telemetry Service (WMTS).

[0118] Various general-purpose computer systems can be used to perform one or more processes, methods, or functions described herein. Additionally or alternatively, various special-purpose computer systems can be used to perform one or more processes, methods, or functions described herein. Furthermore, various programming languages ​​can be used to implement one or more processes, methods, or functions described herein.

[0119] While certain implementations and examples have been described above and shown in the accompanying drawings, it should be understood that these implementations and examples are merely exemplary and not limited to the specific constructions and arrangements shown and described, as various other alternatives, modifications and equivalents will be understood by those skilled in the art.

Claims

1. A medical system comprising: The manipulator assembly includes: An actuator for driving a medical device along the insertion axis of the manipulator assembly; and A brake, the brake being used to inhibit movement of the medical device along the insertion axis; and A control system coupled to the manipulator assembly, the control system being configured to: Determine whether the medical system is in a first operating mode or a second operating mode, the first operating mode involving actuator-driven movement of the medical device along the insertion axis, and the second operating mode involving actuator-driven movement of the medical device without any medical device along the insertion axis; and Based on determining that the medical system is in the second operating mode, the brake is controlled to suppress movement of the medical device along the insertion axis caused by external force.

2. The medical system according to claim 1, wherein, The control system is also configured to: Based on determining that the medical system is in the first operating mode, the brake is controlled to allow the medical device to move along the insertion axis driven by the actuator.

3. The medical system according to claim 1 or 2, further comprising one or more sensors configured to generate sensor data about the medical system, wherein, The control system determines whether the medical system is in the first operating mode or the second operating mode based on the sensor data.

4. The medical system according to claim 3, further comprising: A user input device is used to control the driving of the medical device along the insertion axis based on user input. The one or more sensors include touch sensors disposed on the user input device.

5. The medical system according to claim 4, wherein, The control system determines that the medical system is in the first operating mode based on the touch detected by the touch sensor.

6. The medical system according to claim 4, wherein, The control system determines that the medical system is in the second operating mode based on the absence of touch detected by the touch sensor within at least a pre-specified time interval.

7. The medical system according to claim 4, wherein, The touch sensor includes a capacitive touch sensor.

8. The medical system according to claim 4, wherein, The control system determines that the medical system is in the first operating mode based on the detection of user input from the user input device.

9. The medical system according to claim 4, wherein, The control system determines that the medical system is in the second operating mode based on the absence of user input from the user input device detected within at least a pre-specified time interval.

10. The medical system according to claim 3, wherein, The medical device includes a flexible elongation device having a lumen configured to receive a flexible tool, and the one or more sensors include a tool identification sensor configured to detect the presence of the flexible tool in the lumen.

11. The medical system according to claim 10, wherein, The control system determines that the medical system is in the first operating mode based on the presence of the flexible tool.

12. The medical system according to claim 10, wherein, The flexible tool is a vision probe.

13. The medical system according to claim 10, wherein, The tool identifies a sensor selected from the group consisting of inductive sensors, capacitive sensors, optical sensors, and magnetic switches.

14. The medical system according to claim 3, wherein, The one or more sensors include force sensors configured to sense the external force.

15. The medical system according to claim 14, wherein, The control system determines that the medical system is in the second operating mode based on the detection of the presence of the external force.

16. The medical system according to any one of claims 1 to 15, wherein, The external force is detected based on the control error associated with the actuator when driving the medical device.

17. The medical system according to claim 2, wherein, The control system determines whether the medical system is in the first operating mode or the second operating mode based on the proximity of the medical device to the target.

18. The medical system according to claim 2, wherein, The control system determines whether the medical system is in the first operating mode or the second operating mode based on the user's request.

19. The medical system according to any one of claims 1 to 18, wherein, When in the second operating mode, the control system is configured to servo the actuator when the brake is engaged.

20. The medical system according to any one of claims 1 to 19, wherein: The first operating mode is associated with navigation operations, which include the movement of the medical device toward the target tissue within the anatomical channel, and The second operating mode is associated with medical procedures performed on the target tissue.

21. The medical system according to claim 20, wherein, The medical procedures include one or more of biopsy, ablation, and electroporation.

22. A non-transitory machine-readable medium comprising a plurality of machine-readable instructions executable by one or more processors associated with a medical system, the plurality of machine-readable instructions causing the one or more processors to perform a method comprising: Determine whether the medical system is in a first operating mode or a second operating mode, wherein the first operating mode involves actuator-driven movement of the medical device along the insertion axis, and the second operating mode involves no actuator-driven movement of the medical device along the insertion axis. as well as Based on determining that the medical system is in the second operating mode, the brake is controlled to suppress movement of the medical device along the insertion axis caused by external force.

23. The non-transitory machine-readable medium according to claim 22, wherein, The method further includes: Based on determining that the medical system is in the first operating mode, the brake is controlled to allow the medical device to move along the insertion axis driven by the actuator.

24. The non-transitory machine-readable medium according to claim 22 or 23, wherein, Determining whether the medical system is in the first operating mode or the second operating mode is based on sensor data obtained from one or more sensors of the medical system.

25. The non-transitory machine-readable medium according to claim 24, wherein, The one or more sensors include a touch sensor disposed on a user input device for controlling the drive of the medical device along the insertion axis based on user input.

26. The non-transitory machine-readable medium according to claim 25, wherein, The medical system is determined to be in the first operating mode based on the following: a touch is detected by the touch sensor.

27. The non-transitory machine-readable medium according to claim 25, wherein, The medical system is determined to be in the second operating mode based on the following: the touch sensor detects the absence of touch within at least a pre-specified time interval.

28. The non-transitory machine-readable medium according to claim 25, wherein, The touch sensor includes a capacitive touch sensor.

29. The non-transitory machine-readable medium according to claim 25, wherein, The medical system is determined to be in the first operating mode based on the following: user input is detected by the user input device.

30. The non-transitory machine-readable medium according to claim 25, wherein, The medical system is determined to be in the second operating mode based on the following: the absence of user input from the user input device is detected within at least a pre-specified time interval.

31. The non-transitory machine-readable medium according to claim 24, wherein, The medical device includes a flexible elongation device having a lumen configured to receive a flexible tool, and the one or more sensors include a tool identification sensor configured to detect the presence of the flexible tool in the lumen.

32. The non-transitory machine-readable medium according to claim 31, wherein, The medical system is determined to be in the first operating mode based on the presence of the flexible tool.

33. The non-transitory machine-readable medium according to claim 31, wherein, The flexible tool is a vision probe.

34. The non-transitory machine-readable medium according to claim 31, wherein, The tool identifies a sensor selected from the group consisting of inductive sensors, capacitive sensors, optical sensors, and magnetic switches.

35. The non-transitory machine-readable medium according to claim 24, wherein, The one or more sensors include force sensors configured to sense the external force.

36. The non-transitory machine-readable medium according to claim 35, wherein, The medical system is determined to be in the second operating mode based on the following: the presence of the external force is detected.

37. The non-transitory machine-readable medium according to any one of claims 22 to 36, wherein, The external force is detected based on the control error associated with the actuator when driving the medical device.

38. The non-transitory machine-readable medium according to claim 23, wherein, Determining whether the medical system is in the first operating mode or the second operating mode is based on the proximity of the medical device to the target.

39. The non-transitory machine-readable medium according to claim 23, wherein, Determining whether the medical system is in the first operating mode or the second operating mode is based on user request.

40. The non-transitory machine-readable medium according to any one of claims 22 to 39, wherein, The method further includes: when in the second operating mode, servoing the actuator when the brake is engaged.

41. The non-transitory machine-readable medium according to any one of claims 22 to 40, wherein: The first operating mode is associated with navigation operations, which include the movement of the medical device toward the target tissue within the anatomical channel, and The second operating mode is associated with medical procedures performed on the target tissue.

42. The non-transitory machine-readable medium according to claim 41, wherein, The medical procedures include one or more of biopsy, ablation, and electroporation.

43. A method for operating a medical system, comprising: Determine whether the medical system is in a first operating mode or a second operating mode, wherein the first operating mode involves actuator-driven movement of the medical device along the insertion axis, and the second operating mode involves no actuator-driven movement of the medical device along the insertion axis. as well as Based on determining that the medical system is in the second operating mode, the brake is controlled to suppress movement of the medical device along the insertion axis caused by external force.

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