Fluidics assemblies and related medical systems

Abstract

Fluidics assemblies for transferring fluids with a medical instrument include a connection assembly, a suction conduit, a fluid delivery assembly, and a fluid valve. The fluid valve is actuatable to control the flow of fluid with the medical instrument. Robotic medical systems include the fluidic assemblies with a medical instrument. The systems can also include a robotic drive system and an input device to command the robotic drive system.

Description

FLUIDICS ASSEMBLIES AND RELATED MEDICAL SYSTEMSCROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the priority benefit of U.S. Provisional Application No. 63 / 605,757, filed December 4, 2023, which is hereby incorporated by reference herein in its entirety.FIELD

[0002] Disclosed embodiments relate to fluidics assemblies for medical instruments.BACKGROUND

[0003] Minimally invasive medical techniques are intended to reduce the amount of tissue that is damaged during medical procedures, thereby reducing patient recovery time, discomfort, and harmful side effects. Such minimally invasive techniques may be performed through natural orifices in a patient anatomy or through one or more surgical incisions. Through these natural orifices or incisions, physicians may insert minimally invasive medical instruments (including surgical, diagnostic, therapeutic, and / or biopsy instruments) to reach a target tissue location. One such minimally invasive technique is to use a flexible and / or steerable elongate device, such as a flexible catheter, that can be inserted into anatomic passageways and navigated toward a region of interest within the patient anatomy.SUMMARY

[0004] The following presents a simplified summary of various examples described herein and is not intended to identify key or critical elements or to delineate the scope of the claims.

[0005] In accordance with a first example, a fluidics assembly for transferring fluids with a medical instrument is described herein that includes a connection assembly including a connection conduit, a suction conduit, a fluid delivery assembly including a delivery conduit, and a fluid valve fluidly coupled to the connection assembly, the suction conduit, and the fluid delivery assembly. The fluid valve includes an actuation assembly movable between a first configuration enabling fluid flow from the fluid delivery assembly to the connection assembly and restricting an application of suction force through the connection assembly from the suction conduit and a second configuration applying suction force through the connection assembly from the suction conduit and restricting fluid flow from the fluid delivery assembly.

[0006] In accordance with a second example, a robotic medical system is described herein that includes a robotic drive system, an input device to command the robotic drive system, a flexible steerable instrument, and a fluidics assembly. The flexible steerable instrument includes a backend mechanism and an instrument body extending from the backend mechanism, the instrument body including a lumen, the backend mechanism including a side port fluidly coupled to the lumen. The fluidics assembly is fluidly coupled to the side port of the backend mechanism to control fluid flow through the side port. The fluidics assembly includes a fluid valve configured to be connected with a vacuum source such that actuation of the fluid valve controls application of suction through the lumen of the instrument body as the instrument body is robotically navigated in a patient via the input device.

[0007] In accordance with a third example, a medical system is described herein that includes a medical instrument and a fluidics assembly. The medical instrument includes a backend mechanism and an instrument body extending from the backend mechanism, the instrument body including a lumen, the backend mechanism including a side port fluidly coupled to the lumen. The fluidics assembly couples to the side port and includes a suction conduit for applying suction force, a fluid valve fluidly coupled to the suction conduit and actuatable to control application of suction force through the lumen of the instrument body, and a fluid delivery assembly for delivering fluid through the lumen of the instrument body via the side port.

[0008] In accordance with a fourth example, a fluidics assembly for transferring fluids with a medical instrument is described herein that includes a connection assembly including a connection conduit, a suction conduit, a fluid delivery assembly including a delivery conduit fluidly coupled to the connection assembly, and a fluid valve fluidly coupled between the suction conduit and the connection assembly. The fluid valve includes an actuation assembly movable between: a first configuration restricting an application of suction force through the connection assembly from the suction conduit and a second configuration applying suction force through the connection assembly from the suction conduit and restricting fluid flow from the fluid delivery assembly.

[0009] It is to be understood that both the foregoing general description and the following detailed description are illustrative and explanatory in nature and are intended to provide an understanding of the present disclosure without limiting the scope of the present disclosure. In that regard, additional aspects, features, and advantages of the present disclosure will be apparent to one skilled in the art from the following detailed description.BRIEF DESCRIPTIONS OF THE DRAWINGS

[0010] FIG. 1 is a simplified diagram of a medical system according to some embodiments.

[0011] FIG. 2A is a simplified diagram of a medical instrument system according to some embodiments.

[0012] FIG. 2B is a simplified diagram of a medical instrument including a medical tool within an elongate device according to some embodiments.

[0013] FIGS. 3 A and 3B are simplified diagrams of side views of a patient coordinate space including a medical instrument mounted on an insertion assembly according to some embodiments.

[0014] FIG. 4A is a simplified diagram of a medical system including a medical instrument and a fluidics assembly according to some embodiments.

[0015] FIG. 4B is a simplified diagram of a first example fluidics assembly suitable for the medical system of FIG. 4A according to some embodiments.

[0016] FIG. 4C is a side elevational view of a first example fluid valve suitable for the fluidics assembly of FIG. 4B according to some embodiments.

[0017] FIG. 4D is a cross-sectional view of the fluid valve of FIG. 4C according to some embodiments.

[0018] FIG. 4E is a side elevational view of a second example fluid valve suitable for the fluidics assembly of FIG. 4B according to some embodiments.

[0019] FIG. 4F is a cross-sectional view of a third example fluid valve suitable for the fluidics assembly of FIG. 4B according to some embodiments.

[0020] FIG. 4G is a side elevational view of a fourth example fluid valve suitable for the fluidics assembly of FIG. 4B according to some embodiments.

[0021] FIG. 5A is a simplified diagram of a second fluidics assembly suitable for the medical system of FIG. 4A showing a fluid valve in a first configuration according to some embodiments.

[0022] FIG. 5B is a simplified diagram of the fluidics assembly of FIG. 5A showing the fluid valve in a second configuration according to some embodiments.

[0023] FIG. 5C is a simplified diagram of a third fluidics assembly suitable for the medical system of FIG. 4A showing a fluid valve in a first configuration according to some embodiments.

[0024] FIG. 5D is a simplified diagram of the fluidics assembly of FIG. 5C showing the fluid valve in a second configuration according to some embodiments.

[0025] FIG. 6 is a simplified diagram of a medical system including an actuator, a dock, and the fluidics assembly of FIG. 5A or 5C with a fluid valve of the fluidics assembly received within the dock according to some embodiments.

[0026] Embodiments of the present disclosure and their advantages are best understood by referring to the detailed description that follows. It should be appreciated that like reference numerals are used to identify like elements illustrated in one or more of the figures, wherein showings therein are for purposes of illustrating embodiments of the present disclosure and not for purposes of limiting the same.DETAILED DESCRIPTION

[0027] In the following description, specific details are set forth describing some embodiments consistent with the present disclosure. Numerous specific details are set forth in order to provide a thorough understanding of the embodiments. It will be apparent, however, to one skilled in the art that some embodiments may be practiced without some or all of these specific details. The specific embodiments disclosed herein are meant to be illustrative but not limiting. One skilled in the art may realize other elements that, although not specifically described here, are within the scope and the spirit of this disclosure. In addition, to avoid unnecessary repetition, one or more features shown and described in association with one embodiment may be incorporated into other embodiments unless specifically described otherwise or if the one or more features would make an embodiment non-functional. In some instances, well known methods, procedures, components, and circuits have not been described in detail so as not to unnecessarily obscure aspects of the embodiments.

[0028] This disclosure describes various instruments and portions of instruments in terms of their state in three-dimensional space. As used herein, the term “position” refers to the location of an object or a portion of an object in a three-dimensional space (e.g., three degrees of translational freedom along Cartesian x-, y-, and z-coordinates). As used herein, the term “orientation” refers to the rotational placement of an object or a portion of an object (e.g., one or more degrees of rotational freedom such as, roll, pitch, and yaw). As used herein, the term “pose” refers to the position of an object or a portion of an object in at least one degree of translational freedom and to the orientation of that object or portion of the object in at least one degree of rotational freedom (e.g., up to six total degrees of freedom). As used herein, the term “shape” refers to a set of poses,positions, and / or orientations measured along an object. As used herein, the term “distal” refers to a position that is closer to a procedural site and the term “proximal” refers to a position that is further from the procedural site. Accordingly, the distal portion or distal end of an instrument is closer to a procedural site than a proximal portion or proximal end of the instrument when the instrument is being used as designed to perform a procedure.

[0029] The field of endoscopy can utilize suction (e.g., a negative pressure source) to help remove fluid (e.g., including liquids, secretions, blood, and gases) from a patient’s airway through a flexible device, as well as irrigation with a fluid to help break down mucus within the patient’ s airway or clean the airway of blood to look for any residual bleeding. Valves suitable for bronchoscopy and other endoscopy procedures as described herein provide rapid haptic activation control to a clinician. The valves can also maintain a fully sealed patient breathing volume when not activated, allowing for precise control of patient breathing under anesthesia. The valves can also work in conjunction with fluid delivery devices to allow a user to delivery suction or fluid from different sources through the working channel of the endoscope.

[0030] In some examples, a fluidics assembly for transferring fluids with a medical instrument includes a connection assembly, a suction conduit, and a fluid delivery assembly. The connection assembly includes a connection conduit configured to couple the fluidics assembly to the medical instrument. The delivery assembly includes a delivery conduit. The fluidics assembly further includes a fluid valve that is fluidly coupled to the connection assembly, the suction conduit, and the fluid delivery assembly. The fluid valve includes an actuation assembly that can be moved between a first configuration and a second configuration. In the first configuration, fluid flow is enabled from the fluid delivery assembly to the connection assembly and an application of suction force is restricted from the suction conduit through the connection assembly. In the second configuration, the suction force is applied from the suction conduit through the connection assembly and fluid flow is restricted from the fluid delivery assembly. In further examples, the first configuration of the fluid valve can provide a leak path for suction from the suction conduit.

[0031] The fluidics assembly can be coupled to a medical instrument that has a backend mechanism with a side port for the fluidics assembly and a flexible elongate device defining a lumen, where the side port is fluidly coupled to the lumen. The medical instrument can include an actuator configured to operably couple to the actuation assembly of the fluid valve to control the operation of the fluid valve.

[0032] In some examples, a robotic medical system includes a robotic drive system, an input device to command the robotic drive system, and a flexible, steerable endoscope. The endoscope includes a backend mechanism having a side port and an instrument body that extends from the backend mechanism and includes a lumen fluidly coupled to the side port. The system further includes a fluidics assembly that is fluidly coupled to the side port of the backend mechanism. The fluidics assembly includes a fluid valve having ports to couple to the side port and a vacuum source. The fluid valve is configured to be actuated to control the application of suction through the lumen of the instrument body as the instrument body is robotically navigated in a patient. The system can include an actuator configured to operably couple to the fluid valve to control the operation of the fluid valve and / or the fluid valve can be manually actuated. The fluid valve can have a first configuration the restricts the application of suction through the lumen of the instrument body and a second configuration that applies suction through the lumen of the instrument body. The fluid valve can include a biasing mechanism, such as a spring, to bias the fluid valve to the first configuration.

[0033] In some examples, a medical system is provided that includes a medical instrument and a fluidics assembly. The medical instrument includes a backend mechanism and an instrument body extending from the backend mechanism. The instrument body includes a lumen and the backend mechanism includes a side port fluidly coupled to the lumen. The fluidics assembly couples to the side port and includes a suction conduit and a fluid delivery assembly. The fluidics assembly can be operated to apply suction force through the lumen of the instrument body via the side port, as well as to deliver fluid through the lumen of the instrument body via the side port. The fluidics assembly includes a fluid valve that is actuatable to control the application of suction force through the lumen of the instrument body. In further examples, a manipulation interface of the fluid valve can be actuated to transition the fluid valve to an open configuration that allows fluid flow from the distal opening to the proximal opening when external force is applied to the manipulation interface and transitions the suction valve to a closed configuration that prevents fluid flow from the distal opening to the proximal opening when no external force is applied to the manipulation interface.

[0034] FIG. 1 is a simplified diagram of a medical system 100 according to some embodiments. The medical system 100 may be suitable for use in, for example, surgical, diagnostic (e.g., biopsy), or therapeutic (e.g., ablation, electroporation, etc.) procedures. While some embodiments areprovided herein with respect to such procedures, any reference to medical or surgical instruments and medical or surgical methods is non-limiting. The systems, instruments, and methods described herein may be used for animals, human cadavers, animal cadavers, portions of human or animal anatomy, non-surgical diagnosis, as well as for industrial systems, general or special purpose robotic systems, general or special purpose teleoperational systems, or robotic medical systems.

[0035] As shown in FIG. 1, medical system 100 may include a manipulator assembly 102 that controls the operation of a medical instrument 104 in performing various procedures on a patient P. Medical instrument 104 may extend into an internal site within the body of patient P via an opening in the body of patient P. The manipulator assembly 102 may be teleoperated, nonteleoperated, or a hybrid teleoperated and non-teleoperated assembly with one or more degrees of freedom of motion that may be motorized and / or one or more degrees of freedom of motion that may be non-motorized (e.g., manually operated). The manipulator assembly 102 may be mounted to and / or positioned near a patient table T. A master assembly 106 allows an operator O (e.g., a surgeon, a clinician, a physician, or other user) to control the manipulator assembly 102. In some examples, the master assembly 106 allows the operator O to view the procedural site or other graphical or informational displays. In some examples, the manipulator assembly 102 may be excluded from the medical system 100 and the instrument 104 may be controlled directly 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 the instrument 104.

[0036] The master assembly 106 may be located at a surgeon’s console which is in proximity to (e.g., in the same room as) a patient table T on which patient P is located, such as at the side of the patient table T. In some examples, the master assembly 106 is remote from the patient table T, such as in in a different room or a different building from the patient table T. The master assembly 106 may include one or more control devices for controlling the manipulator assembly 102. The control devices may include any number of a variety of input devices, such as joysticks, trackballs, scroll wheels, directional pads, buttons, data gloves, trigger-guns, hand-operated controllers, voice recognition devices, motion or presence sensors, and / or the like.

[0037] The manipulator assembly 102 supports the medical instrument 104 and may include a kinematic structure of links that provide a set-up structure. The links may include one or more non-servo controlled links (e.g., one or more links that may be manually positioned and locked inplace) and / or one or more servo controlled links (e.g., one or more links that may be controlled in response to commands, such as from a control system 112). The manipulator assembly 102 may include a plurality of actuators (e.g., motors) that drive inputs on the medical instrument 104 in response to commands, such as from the control system 112. The actuators may include drive systems that move the medical instrument 104 in various ways when coupled to the medical instrument 104. For example, one or more actuators may advance medical instrument 104 into a naturally or surgically created anatomic orifice. Actuators may control articulation of the medical instrument 104, such as by moving the distal end (or any other portion) of medical instrument 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 in three degrees of rotational motion (e.g., rotation about the X, Y, Z Cartesian axes). One or more actuators may control rotation of the medical instrument about a longitudinal axis. Actuators can also be used to move an articulable end effector of medical instrument 104, such as for grasping tissue in the jaws of a biopsy device and / or the like, or may be used to move or otherwise control tools (e.g., imaging tools, ablation tools, biopsy tools, electroporation tools, etc.) that are inserted within the medical instrument 104.

[0038] The medical system 100 may include a sensor system 108 with one or more sub-systems for receiving information about the manipulator assembly 102 and / or the medical instrument 104. Such sub-systems may include a position sensor system (e.g., that uses electromagnetic (EM) sensors or other types of sensors that detect position or location); a shape sensor system for determining the position, orientation, speed, velocity, pose, and / or shape of a distal end and / or of one or more segments along a flexible body of the medical instrument 104; a visualization system (e.g., using a color imaging device, an infrared imaging device, an ultrasound imaging device, an x-ray imaging device, a fluoroscopic imaging device, a computed tomography (CT) imaging device, a magnetic resonance imaging (MRI) imaging device, or some other type of imaging device) for capturing images, such as from the distal end of medical instrument 104 or from some other location; and / or actuator position sensors such as resolvers, encoders, potentiometers, and the like that describe the rotation and / or orientation of the actuators controlling the medical instrument 104.

[0039] The medical system 100 may include a display system 110 for displaying an image or representation of the procedural site and the medical instrument 104. Display system 110 andmaster assembly 106 may be oriented so physician O can control medical instrument 104 and master assembly 106 with the perception of telepresence.

[0040] In some embodiments, the medical instrument 104 may include a visualization system, which may include an image capture assembly that records a concurrent or real-time image of a procedural site and provides the image to the operator O through one or more displays of display system 110. The image capture assembly may include various types of imaging devices. The concurrent image may be, for example, a two-dimensional image or a three-dimensional image captured by an endoscope positioned within the anatomical procedural site. In some examples, the visualization system may include endoscopic components that may be integrally or removably coupled to medical instrument 104. Additionally or alternatively, a separate endoscope, attached to a separate manipulator assembly, may be used with medical instrument 104 to image the procedural site. The visualization system may be implemented as hardware, firmware, software or a combination thereof which interact with or are otherwise executed by one or more computer processors, such as of the control system 112.

[0041] Display system 110 may also display an image of the procedural site and medical instruments, which may be captured by the visualization system. In some examples, the medical system 100 provides a perception of telepresence to the operator O. For example, images captured by an imaging device at a distal portion of the medical instrument 104 may be presented by the display system 110 to provide the perception of being at the distal portion of the medical instrument 104 to the operator O. The input to the master assembly 106 provided by the operator O may move the distal portion of the medical instrument 104 in a manner that corresponds with the nature of the input (e.g., distal tip turns right when a trackball is rolled to the right) and results in corresponding change to the perspective of the images captured by the imaging device at the distal portion of the medical instrument 104. As such, the perception of telepresence for the operator O is maintained as the medical instrument 104 is moved using the master assembly 106. The operator O can manipulate the medical instrument 104 and hand controls of the master assembly 106 as if viewing the workspace in substantially true presence, simulating the experience of an operator that is physically manipulating the medical instrument 104 from within the patient anatomy.

[0042] In some examples, the display system 110 may present virtual images of a procedural site that are created using image data recorded pre-operatively (e.g., prior to the procedure performed by the medical instrument system 200) or intra-operatively (e.g., concurrent with theprocedure performed by the medical instrument system 200), such as image data created using computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET), fluoroscopy, thermography, ultrasound, optical coherence tomography (OCT), thermal imaging, impedance imaging, laser imaging, nanotube X-ray imaging, and / or the like. The virtual images may include two-dimensional, three-dimensional, or higher-dimensional (e.g., including, for example, time based or velocity-based information) images. In some examples, one or more models are created from pre-operative or intra-operative image data sets and the virtual images are generated using the one or more models.

[0043] In some examples, for purposes of imaged guided medical procedures, display system 110 may display a virtual image that is generated based on tracking the location of medical instrument 104. For example, the tracked location of the medical instrument 104 may be registered (e.g., dynamically referenced) with the model generated using the pre-operative or intra-operative images, with different portions of the model correspond with different locations of the patient anatomy. As the medical instrument 104 moves through the patient anatomy, the registration is used to determine portions of the model corresponding with the location and / or perspective of the medical instrument 104 and virtual images are generated using the determined portions of the model. This may be done to present the operator O with virtual images of the internal procedural site from viewpoints of medical instrument 104 that correspond with the tracked locations of the medical instrument 104.

[0044] The medical system 100 may also include the control system 112, which may include processing circuitry that implements the some or all of the methods or functionality discussed herein. The control system 112 may include at least one memory and at least one processor for controlling the operations of the manipulator assembly 102, the medical instrument 104, the master assembly 106, the sensor system 108, and / or the display system 110. Control system 112 may include instructions (e.g., a non-transitory machine -readable medium storing the instructions) that when executed by the at least one processor, configures the one or more processors to implement some or all of the methods or functionality discussed herein. While the control system 112 is shown as a single block in FIG. 1, the control system 112 may include two or more separate data processing circuits with one portion of the processing being performed at the manipulator assembly 102, another portion of the processing being performed at the master assembly 106, and / or the like. In some examples, the control system 112 may include other types of processing circuitry,such as application-specific integrated circuits (ASICs) and / or field-programmable gate array (FPGAs). The control system 112 may be implemented using hardware, firmware, software, or a combination thereof.

[0045] In some examples, the control system 112 may receive feedback from the medical instrument 104, such as force and / or torque feedback. Responsive to the feedback, the control system 112 may transmit signals to the master assembly 106. In some examples, the control system 112 may transmit signals instructing one or more actuators of the manipulator assembly 102 to move the medical instrument 104. In some examples, the control system 112 may transmit informational displays regarding the feedback to the display system 110 for presentation or perform other types of actions based on the feedback.

[0046] The control system 112 may include a virtual visualization system to provide navigation assistance to operator O when controlling the medical instrument 104 during an image-guided medical procedure. Virtual navigation using the virtual visualization system may be based upon an acquired pre-operative or intra-operative dataset of anatomic passageways of the patient P. The control system 112 or a separate computing device may convert the recorded images, using programmed instructions alone or in combination with operator inputs, into a model of the patient anatomy. The model may include a segmented two-dimensional or three-dimensional composite representation of a partial or an entire anatomic organ or anatomic region. An image data set may be associated with the composite representation. The virtual visualization system may obtain sensor data from the sensor system 108 that is used to compute an (e.g., approximate) location of the medical instrument 104 with respect to the anatomy of patient P. The sensor system 108 may be used to register and display the medical instrument 104 together with the pre-operatively or intra-operatively recorded images. For example, PCT Publication WO 2016 / 191298 (published December 1, 2016 and titled “Systems and Methods of Registration for Image Guided Surgery”), which is incorporated by reference herein in its entirety, discloses example systems.

[0047] During a virtual navigation procedure, the sensor system 108 may be used to compute the (e.g., approximate) location of the medical instrument 104 with respect to the anatomy of patient P. The location can be used to produce both macro-level (e.g., external) tracking images of the anatomy of patient P and virtual internal images of the anatomy of patient P. The system may include one or more electromagnetic (EM) sensors, fiber optic sensors, and / or other sensors to register and display a medical instrument together with pre-operatively recorded medical images.For example, U.S. Patent No. 8,900,131 (filed May 13, 201 1 and titled “Medical System Providing Dynamic Registration of a Model of an Anatomic Structure for Image-Guided Surgery”), which is incorporated by reference herein in its entirety, discloses example systems.

[0048] Medical system 100 may further include operations and support systems (not shown) such as illumination systems, steering control systems, irrigation systems, and / or suction systems. In some embodiments, the medical system 100 may include more than one manipulator assembly and / or more than one master assembly. The exact number of manipulator assemblies may depend on the medical procedure and space constraints within the procedural room, among other factors. Multiple master assemblies may be co-located or they may be positioned in separate locations. Multiple master assemblies may allow more than one operator to control one or more manipulator assemblies in various combinations.

[0049] FIG. 2A is a simplified diagram of a medical instrument system 200 according to some embodiments. The medical instrument system 200 includes a flexible elongate device 202 (also referred to as elongate device 202), a drive unit 204, and a medical tool 226 that collectively is an example of a medical instrument 104 of a medical system 100. The medical system 100 may be a teleoperated system, a non- teleoperated system, or a hybrid teleoperated and non-teleoperated system, as explained with reference to FIG. 1. A visualization system 231, tracking system 230, and navigation system 232 are also shown in FIG. 2A and are example components of the control system 112 of the medical system 100. In some examples, the medical instrument system 200 may be used for non-teleoperational exploratory procedures or in procedures involving traditional manually operated medical instruments, such as endoscopy. The medical instrument system 200 may be used to gather (e.g., measure) a set of data points corresponding to locations within anatomic passageways of a patient, such as patient P.

[0050] The elongate device 202 is coupled to the drive unit 204. The elongate device 202 includes a channel 221 through which the medical tool 226 may be inserted. The elongate device 202 navigates within patient anatomy to deliver the medical tool 226 to a procedural site. The elongate 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 approximately 3 mm outer diameter. Other flexible body outer diameters may be larger or smaller.

[0051] Medical instrument system 200 may include the tracking system 230 for determining the position, orientation, speed, velocity, pose, and / or shape of the flexible body 216 at the distalend 218 and / or of one or more segments 224 along flexible body 216, as will be described in further detail below. The tracking system 230 may include one or more sensors and / or imaging devices. The flexible body 216, such as the length between the distal end 218 and the proximal end 217, may include multiple segments 224. The tracking system 230 may be implemented using hardware, firmware, software, or a combination thereof. In some examples, the tracking system 230 is part of control system 112 shown in FIG. 1.

[0052] Tracking system 230 may track the distal end 218 and / or one or more of the segments 224 of the flexible body 216 using a shape sensor 222. The shape sensor 222 may include an optical fiber aligned with the flexible body 216 (e.g., provided within an interior channel of the flexibly body 216 or mounted externally along the flexible body 216). In some examples, the optical fiber may have a diameter of approximately 200 pm. In other examples, the diameter may be larger or smaller. The optical fiber of the shape sensor 222 may form a fiber optic bend sensor for determining the shape of flexible body 216. Optical fibers including Fiber Bragg Gratings (FBGs) may be used to provide strain measurements in structures in one or more dimensions. Various systems and methods for monitoring the shape and relative position of an optical fiber in three dimensions, which may be applicable in some embodiments, are described in U.S. Patent Application Publication No. 2006 / 0013523 (filed July 13, 2005 and titled “Fiber optic position and shape sensing device and method relating thereto”); U.S. Patent No. 7,772,541 (filed on March 12, 2008 and titled “Fiber Optic Position and / or Shape Sensing Based on Rayleigh Scatter”); and U.S. Patent No. 8,773,650 (filed on Sept. 2, 2010 and titled “Optical Position and / or Shape Sensing”), which are all incorporated by reference herein in their entireties. Sensors in some embodiments may employ other suitable strain sensing techniques, such as Rayleigh scattering, Raman scattering, Brillouin scattering, and Fluorescence scattering.

[0053] In some examples, the shape of the flexible body 216 may be determined using other techniques. For example, a history of the position and / or pose of the distal end 218 of the flexible body 216 can be used to reconstruct the shape of flexible body 216 over an interval of time (e.g., as the flexible body 216 is advanced or retracted within a patient anatomy). In some examples, the tracking system 230 may alternatively and / or additionally track the distal end 218 of the flexible body 216 using a position sensor system 220. Position sensor system 220 may be a component of an EM sensor system with the position sensor system 220 including one or more position sensors. Although the position sensor system 220 is shown as being near the distal end 218 of the flexiblebody 216 to track the distal end 218, the number and location of the position sensors of 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 may be subjected to an externally generated electromagnetic field. Each coil of position sensor system 220 may produce an induced electrical signal having characteristics that depend on the position and orientation of the coil relative to the externally generated electromagnetic field. The position sensor system 220 may 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, the position sensor system 220 may be configured and positioned to measure six degrees of freedom, e.g., three position coordinates X, Y, Z and three orientation angles indicating pitch, yaw, and roll of a base point. In some examples, the position sensor system 220 may be configured and positioned to measure five degrees of freedom, e.g., three position coordinates X, Y, Z and two orientation angles indicating pitch and yaw of a base point. Further description of a position sensor system, which may be applicable in some embodiments, is provided in U.S. Patent No. 6,380,732 (filed August 11, 1999 and titled “Six- Degree of Freedom Tracking System Having a Passive Transponder on the Object Being Tracked”), which is incorporated by reference herein in its entirety.

[0054] In some embodiments, the tracking system 230 may alternately and / or additionally rely on a collection of pose, position, and / or orientation data stored for a point of an elongate device 202 and / or medical tool 226 captured during one or more cycles of alternating motion, such as breathing. This stored data may be used to develop shape information about the flexible body 216. In some examples, a series of position sensors (not shown), such as EM sensors like the sensors in position sensor 220 or some other type of position sensors may be positioned along the flexible body 216 and used for shape sensing. In some examples, a history of data from one or more of these position sensors taken during a procedure may be used to represent the shape of elongate device 202, particularly if an anatomic passageway is generally static.

[0055] FIG. 2B is a simplified diagram of the medical tool 226 within the elongate device 202 according to some embodiments. The flexible body 216 of the elongate device 202 may include the channel 221 sized and shaped to receive the medical tool 226. In some embodiments, the medical tool 226 may be used for procedures such as diagnostics, imaging, surgery, biopsy, ablation, illumination, irrigation, suction, electroporation, etc. Medical tool 226 can be deployed through channel 221 of flexible body 216 and operated at a procedural site within the anatomy.Medical instrament 226 may be, for example, an image capture probe, a biopsy tool (e.g., a needle, grasper, brash, etc.), an ablation tool (e.g., a laser ablation tool, radio frequency (RF) ablation tool, cryoablation tool, thermal ablation tool, heated liquid ablation tool, etc.), an electroporation tool, and / or another surgical, diagnostic, or therapeutic tool. In some examples, the medical tool 226 may include an end effector having a single working member such as a scalpel, a blunt blade, an optical fiber, an electrode, and / or the like. Other end types of end effectors may include, for example, forceps, graspers, scissors, staplers, clip appliers, and / or the like. Other end effectors may further include electrically activated end effectors such as electrosurgical electrodes, transducers, sensors, and / or the like.

[0056] The medical tool 226 may be a biopsy tool used to remove sample tissue or a sampling of cells from a target anatomic location. In some examples, the biopsy tool is a flexible needle. The biopsy tool may further include a sheath that can surround the flexible needle to protect the needle and interior surface of the channel 221 when the biopsy tool is within the channel 221. The medical tool 226 may be an image capture probe that includes a distal portion with a stereoscopic or monoscopic camera that may be placed at or near the distal end 218 of flexible body 216 for capturing images (e.g., still or video images). The captured images may be processed by the visualization system 231 for display and / or provided to the tracking system 230 to support tracking of the distal end 218 of the flexible body 216 and / or one or more of the segments 224 of the flexible body 216. The image capture probe may include a cable for transmitting the captured image data that is coupled to an imaging device at the distal portion of the image capture probe. In some examples, the image capture probe may include a fiber-optic bundle, such as a fiberscope, that couples to a more proximal imaging device of the visualization system 231. The image capture probe may be single-spectral or multi- spectral, for example, capturing image data in one or more of the visible, near-infrared, infrared, and / or ultraviolet spectrums. The image capture probe may also include one or more light emitters that provide illumination to facilitate image capture. In some examples, the image capture probe may use ultrasound, x-ray, fluoroscopy, CT, MRI, or other types of imaging technology.

[0057] In some examples, the image capture probe is inserted within the flexible body 216 of the elongate device 202 to facilitate visual navigation of the elongate device 202 to a procedural site and then is replaced within the flexible body 216 with another type of medical tool 226 that performs the procedure. In some examples, the image capture probe may be within the flexiblebody 216 of the elongate device 202 along with another type of medical tool 226 to facilitate simultaneous image capture and tissue intervention, such as within the same channel 221 or in separate channels. A medical tool 226 may be advanced from the opening of the channel 221 to perform the procedure (or some other functionality) and then retracted back into the channel 221 when the procedure is complete. The medical tool 226 may be removed from the proximal end 217 of the flexible body 216 or from another optional instrument port (not shown) along flexible body 216.

[0058] In some examples, the elongate device 202 may include integrated imaging capability rather than utilize a removable image capture probe. For example, the imaging device (or fiberoptic bundle) and the light emitters may be located at the distal end 218 of the elongate device 202. The flexible body 216 may include one or more dedicated channels that carry the cable(s) and / or optical fiber(s) between the distal end 218 and the visualization system 231. Here, the medical instrument system 200 can perform simultaneous imaging and tool operations.

[0059] In some examples, the medical tool 226 is capable of controllable articulation. The medical tool 226 may house cables (which may also be referred to as pull wires), linkages, or other actuation controls (not shown) that extend between its proximal and distal ends to controllably bend the distal end of medical tool 226, such as discussed herein for the flexible elongate device 202. The medical tool 226 may be coupled to a drive unit 204 and the manipulator assembly 102. In these examples, the elongate device 202 may be excluded from the medical instrument system 200 or may be a flexible device that does not have controllable articulation. Steerable instruments or tools, applicable in some embodiments, are further described in detail in U.S. Patent No. 7,316,681 (filed on Oct. 4, 2005 and titled “Articulated Surgical Instrument for Performing Minimally Invasive Surgery with Enhanced Dexterity and Sensitivity”) and U.S. Patent No. 9,259,274 (filed Sept. 30, 2008 and titled “Passive Preload and Capstan Drive for Surgical Instruments”), which are incorporated by reference herein in their entireties.

[0060] The flexible body 216 of the elongate device 202 may also or alternatively house cables, linkages, or other steering controls (not shown) that extend between the drive unit 204 and the distal end 218 to controllably bend the distal end 218 as shown, for example, by broken dashed line depictions 219 of the distal end 218 in FIG. 2A. In some examples, at least four cables are used to provide independent up-down steering to control a pitch of the distal end 218 and left-right steering to control a yaw of the distal end 281. In these examples, the flexible elongate device 202may be a steerable catheter. Examples of steerable catheters, applicable in some embodiments, are described in detail in PCT Publication WO 2019 / 018736 (published Jan. 24, 2019 and titled “Flexible Elongate Device Systems and Methods”), which is incorporated by reference herein in its entirety.

[0061] In embodiments where the elongate device 202 and / or medical tool 226 are actuated by a teleoperational assembly (e.g., the manipulator assembly 102), the drive unit 204 may include drive inputs that removably couple to and receive power from drive elements, such as actuators, of the teleoperational assembly. In some examples, the elongate device 202 and / or medical tool 226 may include gripping features, manual actuators, or other components for manually controlling the motion of the elongate device 202 and / or medical tool 226. The elongate device 202 may be steerable or, alternatively, the elongate device 202 may be non-steerable with no integrated mechanism for operator control of the bending of distal end 218. In some examples, one or more channels 221 (which may also be referred to as lumens), through which medical tools 226 can be deployed and used at a target anatomical location, may be defined by the interior walls of the flexible body 216 of the elongate device 202.

[0062] In some examples, the medical instrument system 200 (e.g., the elongate device 202 or medical tool 226) may include a flexible bronchial instrument, such as a bronchoscope or bronchial catheter, for use in examination, diagnosis, biopsy, and / or treatment of a lung. The medical instrument system 200 may also be suited for navigation and treatment of other tissues, via natural or surgically created connected passageways, in any of a variety of anatomic systems, including the colon, the intestines, the kidneys and kidney calices, the brain, the heart, the circulatory system including vasculature, and / or the like.

[0063] The information from the tracking system 230 may be sent to the navigation system 232, where the information may be combined with information from the visualization system 231 and / or pre-operatively obtained models to provide the physician, clinician, surgeon, or other operator with real-time position information. In some examples, the real-time position information may be displayed on the display system 110 for use in the control of the medical instrument system 200. In some examples, the navigation system 232 may utilize the position information as feedback for positioning medical instrument system 200. Various systems for using fiber optic sensors to register and display a surgical instrument with surgical images, applicable in some embodiments, are provided in U.S. Patent No. 8,900,131 (filed May 13, 2011 and titled “Medical SystemProviding Dynamic Registration of a Model of an Anatomic Structure for Image-Guided Surgery”), which is incorporated by reference herein in its entirety.

[0064] FIGS. 3 A and 3B are simplified diagrams of side views of a medical instrument mounted on an insertion assembly and position to treat a patient according to some embodiments. As shown in FIGS. 3A and 3B, a surgical environment 300 includes a patient P positioned on the table T of FIG. 1. Patient P may be stationary within the surgical environment in the sense that gross patient movement is limited by sedation, restraint, and / or other means. Cyclic anatomic motion including respiration and cardiac motion of patient P may continue, unless patient is asked to hold his or her breath to temporarily suspend respiratory motion. Accordingly, in some embodiments, data may be gathered at a specific, phase in respiration, and tagged and identified with that phase. In some embodiments, the phase during which data is collected may be inferred from physiological information collected from patient P. Within surgical environment 300, a backend mechanism 304 can be removably coupled to an instrument carriage 306. In some embodiments, the backend mechanism 304 may be formed of a housing containing operational components for cables used to provide independent up down steering to control a pitch of distal end 318 and left right steering to control a yaw of distal end 318. In addition, the backend mechanism 304 may comprise EM sensors, shape- sensors, and / or other sensor modalities and or provide connectors coupling sensing modalities to an instrument such as elongate member 310.

[0065] Instrument camage 306 can be mounted to an insertion stage 308 which is fixed within surgical environment 300. Alternatively, insertion stage 308 may be movable but have a known location (e.g., via a tracking sensor or other tracking device) within surgical environment 300. Instrument carriage 306 may be a component of a teleoperational manipulator or a non- teleoperational manipulator assembly (e.g., manipulator assembly 102) that controls insertion motion (i.e., motion along the A axis) and, optionally, motion of a distal end 318 of an elongate member 310 in multiple directions including yaw, pitch, and roll. Instrument carriage 306 or insertion stage 308 may include actuators, such as servomotors, (not shown) that control motion of instrument carriage 306 along insertion stage 308, control motion of the distal end 318 of elongate member 310 in yaw / pitch, and / or control roll motion of elongate member 310 along a longitudinal axis.

[0066] Elongate member 310 is coupled to backend mechanism 304. Backend mechanism 304 is coupled and fixed relative to instrument carriage 306. In some embodiments, an optical fibershape sensor 314 is fixed at a proximal point 316 on backend mechanism 304. In some embodiments, proximal point 316 of optical fiber shape sensor 314 may be movable along with backend mechanism 304 but the location of proximal point 316 may be known (e.g., via a tracking sensor or other tracking device). Shape sensor 314 measures a shape from proximal point 316 to another point such as distal end 318 or a point along a distal portion of elongate member 310.

[0067] A position measuring device 320 provides information about the position of backend mechanism 304 as it moves on insertion stage 308 along an insertion axis A. Position measuring device 320 may include resolvers, encoders, potentiometers, and / or other sensors that determine the rotation and / or orientation of the actuators controlling the motion of instrument carriage 306 and consequently the motion of backend mechanism 304. In some embodiments, insertion stage 308 is linear. In some embodiments, insertion stage 308 may be curved or have a combination of curved and linear sections.

[0068] FIG. 3A shows backend mechanism 304 and instrument carriage 306 in a retracted position along insertion stage 308. In this retracted position, proximal point 316 is at a position Lo on axis A. In this position along insertion stage 308 a component of the location of proximal point 316 may be set to a zero and / or another reference value to provide a base reference to describe the position of instrument carriage 306, and thus proximal point 316, on insertion stage 308. With this retracted position of backend mechanism 304 and instrument carriage 306, distal end 318 of elongate member 310 may be positioned proximal to, e.g. just inside, just outside, or otherwise near an entry orifice of patient P. Also in this position, position measuring device 320 may be set to a zero and / or another reference value (e.g., 1=0). In FIG. 3B, backend mechanism 304 and instrument carriage 306 have advanced along the linear track of insertion stage 308 and distal end 318 of elongate member 310 has advanced into patient P. In this advanced position, the proximal point 316 is at a position Li on the axis A. In some examples, encoder and / or other position data from one or more actuators controlling movement of instrument carriage 306 along insertion stage 308 and / or one or more position sensors associated with instrument carriage 306 and / or insertion stage 308 is used to determine the position Lx of proximal point 316 relative to position Lo. In some examples, position Lx may further be used as an indicator of the distance or insertion depth to which distal end 318 of elongate member 310 is inserted into the passageways of the anatomy of patient P.

[0069] In FIG. 3 A, the backend mechanism 304 includes a mounting face 360, that may define a mounting plane. A portion of the mounting face 360, referred to as an interfacing region, is disposed against the instrument carriage 306, while another portion of the mounting face 360, referred to as a non-interfacing region, protrudes outwardly beyond an edge of the instrument carriage 306. As can be seen, the elongate member 310 extends from the backend mechanism 304, out of the mounting face 360, and past the instrument carriage 306.

[0070] A medical system 400, such as a robotic endoscope system, is shown in FIG. 4A. The medical system 400 includes a robotic drive system 402, an input device 404 to command the robotic drive system 402, and a medical instrument 406. According to some embodiments consistent with FIGS. 1-3, the robotic drive system 402 may correspond to the manipulator assembly 102 and / or drive unit 204, the input device 404 may correspond to the master assembly 106, and the medical instrument 406 may correspond to the backend mechanism 304, elongate device 202, and / or the elongate member 310.

[0071] As shown, the medical instrument 406 includes a backend mechanism 408 and an instrument body 410 extending from the backend mechanism 408. The instrument body 410 includes a lumen 412. In some examples, the instrument body 410 can be a flexible elongate device / steerable instrument, such as a catheter, and in some forms, the instrument body 410 can include an articulable body portion 414 (e.g., distal end 218 of flexible body 216) and a distal opening 415.

[0072] The backend mechanism 408 and / or the instrument body 410 further includes a proximal port 416 providing a proximal opening for the instrument body 410 and a side port 418, where both ports 416, 418 are fluidly coupled to the lumen 412. The proximal port 416 is coaxially aligned with the lumen 412, while the side port 418 is transverse (e.g., orthogonal) with respect to a longitudinal axis of the lumen 412. In some examples, each of the ports 416, 418 can include a locking connector 420 to fluidly couple the lumen 412 of the instrument body 410 to external devices. The proximal port 416 may be suitable and configured to receive a medical tool for insertion within the lumen 412 of the instrument body 410, allowing fluid to flow between the proximal port 416 and within space between the lumen 412 and the medical tool or between the proximal port 416 and an internal lumen of the medical tool. In some examples, the side port 418 and proximal port 416 may connect to the lumen 412 at different angles. For example, the side port 418 and proximal port 416 may be at different (e.g., orthogonal) angles to allow differentcomponent connections, but the side port 418 may not necessarily be orthogonal to the lumen 412 and / or the proximal port 416 may not necessarily be coaxially aligned with the lumen 412.

[0073] The backend mechanism 408 includes a housing 422 having protruding bosses 424 defining passages sized for the ports 416, 418 to extend therethrough to position the locking connectors 420 exterior of the housing 422. In some examples, the backend mechanism 408 can also include seal members 426 configured to fluidly seal the proximal port 416 and the side port 418 when not in use (e.g., a tool is not inserted through the proximal port 416 or a fluidic assembly, described in detail below, is detached from the side port 418) or with a component, such as a tool, inserted through the seal member 426.

[0074] The medical system 400 further includes a fluidics assembly 430 configured to fluidly couple to the side port 418 of the backend mechanism 408 / instrument body 410 to control fluid flow through the side port 418. In some examples, the fluidics assembly 430 is configured to additionally or alternatively fluidly couple to the proximal port 416. As shown in FIGS. 4B and FIGS. 5A-5D, the fluidics assembly 430 includes a suction conduit 434 and a fluid delivery assembly 436 having a delivery conduit 438. The suction conduit 434 is configured to be connected with a vacuum source 440 for applying suction force through the lumen 412 and distal opening 415 of the instrument body 410 via the side port 418. The fluid delivery assembly 436 is for delivering / supplying fluid through the lumen 412 and distal opening 415 of the instrument body 410 via the side port 418. The fluidics assembly 430 can further include a connection assembly 442 fluidly coupled to both the suction conduit 434 and the fluid delivery assembly 436. The connection assembly 442 has a connection conduit 444 and a connector 446 to secure to the connector 420 of the side port 418 to couple the fluidics assembly 430 to the side port 418. In some examples, the fluidics assembly 430 may be permanently connected to side port 418 via the connection conduit 444 and eliminate the need for the connector 446. Here, the fluidics assembly 430 is integrated with the medical instrument 406. Each of the conduits 434, 438, 444 can be flexible tubing, allowing the fluidics assembly 430 to be moved easily relative to the medical instrument 406 or the conduits 434, 438, 444 may be rigid to maintain a fixed position of the fluidics assembly 430 relative to the medical instrument 406.

[0075] With this configuration, the medical system 400 can advantageously provide suction via the vacuum source 440 and irrigation via the fluid delivery assembly 436 through the lumen 412 both with and without a medical tool inserted into / through the lumen 412 from the proximal port416. For example, as described above, with clearance between the lumen 412 and the medical tool inserted therein, fluid may flow within this clearance both through the distal opening 415 of the instrument body 410 and in from the distal opening 415 of the instrument body 410 through the lumen 412.

[0076] In some examples, the fluid delivery assembly 436 can include a flow control device 448 (e.g., a one-way valve, clamp, etc.) to prevent unwanted liquid flow through the delivery conduit 438 and a fluid delivery device 450 that provides fluid to the delivery conduit 438. The fluid delivery device 450 can be any suitable device, including, for example, a syringe, a pump, a reservoir, and so forth.

[0077] As shown in FIGS. 4C-4G, the fluidics assembly 430 includes a fluid valve 452a-d configured to be connected with the suction conduit 434 and the vacuum source 440 thereof, such that actuation of the fluid valve 452a-d controls the application of suction through the lumen 412 of the instrument body 410, such as when the instrument body 410 is being robotically controlled within a patient via the input device 404.

[0078] The fluid valve 452a-d includes a valve body 454 having a proximal opening 456 and a distal opening 458. An actuation assembly 460 of the fluid valve 452a-d is movable from a first, closed configuration preventing fluid flow between the proximal and distal openings 456, 458 to a second, open configuration allowing fluid flow between the proximal and distal openings 456, 458. The fluid valve 452a-d is configured to be in the closed configuration when no external force is applied to the actuation assembly 460 to prevent an unintended flow of fluid between the fluidics assembly 430 and the instrument body 410.

[0079] The fluid valve 452a-d of these examples provide a leak path through a leak opening 462 defined in the valve body 454 for suction from the suction conduit 434 so that suction is not applied when not intended or such that no residual negative pressure is maintained inside the lumen of the body. The actuation assembly 460 includes a first seal 464 and a second seal 466. The first seal 464 prevents fluid flow between the proximal and distal openings 456, 458 in the closed configuration. This ensures no flow path for the suction from the vacuum source 440 to the medical instrument 406. It also ensures no flow from fluid delivery device 450 can travel backward through the valve body 454. The second seal 466 seals the leak opening 462 in the open configuration. The actuation assembly 460 further includes a spring 468 to bias the actuation assembly 460 to the closed configuration.

[0080] As shown, the actuation assembly 460 can include a valve stem 470 movable between the first and second configurations, and the first and second seals 464, 466 can be coupled to the valve stem 470. The first seal 464 can be positioned to selectively engage and seal against a valve seat 472 defined in the valve body 454. The second seal 466 can be disposed adjacent to the leak opening 462 to selectively engage and seal against the valve body 454 around the leak opening 462. As shown, the spring 468 can be operably coupled to the valve stem 470 to bias the first seal 464 into engagement with the valve seat 472 and space the second seal 466 from the leak opening 462.

[0081] The actuation assembly 460 can extend through the leak opening 462 and include a button 474 disposed exteriorly to the valve body 454. The button 474 can be integral with the valve stem 470 or coupled thereto by any suitable method, such as welding, adhesive, friction fit, and so forth. To actuate the fluid valve 452a-d, the button 474 is pressed towards the valve body 454 which causes the first seal 464 to disengage from the valve seat 472 and the second seal 466 to engage the valve body 454 around the leak opening 462.

[0082] While sharing the above configurations, the example fluid valves shown in FIGS. 4C- 4G also show different options for providing grip / manipulation structure on an exterior of the fluid valve 452a-d, different options for valve housing assembly (e.g., connecting components to mount the actuation assembly 460 within the valve 452a-d, different options for providing the second seal 466, and so forth.

[0083] In some examples, as shown in FIG. 4F, the button 474 can include the second seal 466 (e.g., have a seal material extend around at least a portion of the button 474 or the button 474 can be formed of the seal material). In some examples, a seal with a similar functionality as the second seal 466 can be formed by the finger or gloved finger of the user and the second seal 466 can be excluded from the actuation assembly 460. In other examples, as shown in FIGS. 4D and 4G, the second seal 466 can be separate from the button 474 and disposed adjacent to the button 474 between the button 474 and the leak opening 462.

[0084] In some examples, the button 474 can be part of a manipulation interface 476 of the fluid valve 452 that also includes manipulation structure 478 on the fluid valve 452 to facilitate handling of the fluid valve 452. In one example, the manipulation structure 478 can be ribs 478a to provide a textured surface for gripping. The ribs 478a can have a convex (FIGS. 4C and 4D) or a concave (FIG. 4G) configuration along a height of the valve body 454. In another example, themanipulation structure 478 can include finger grips 478b (FIG. 4E) disposed on an opposite side of the valve body 454 from the button 474 to facilitate onc-handcd operation of the fluid valve 452.

[0085] In some examples, the fluid valve 452 can include a removable bottom cap 480 that is secured to the valve body 454. With this configuration, the valve stem 470 and spring 468 can be loaded through an open bottom 482 of the valve body 454 and secured in place by coupling the bottom cap 480 to the valve body 454. The bottom cap 480 can secured to the valve body 454 by any suitable method, including, for example, snap fit connectors 483a as shown in FIGS. 4C, 4E, and 4G, threading 483b as shown in FIG. 4F, adhesive, friction fit, and so forth. Additionally, the bottom cap 480 can include the manipulation structure 478, such as the finger grips 478b.

[0086] As shown in FIG. 4B, the fluidics assembly 430 of this form includes a hub 484 having proximal connections 486 fluidly coupled to the suction conduit 434 and delivery conduit 438, a distal connection 488 fluidly coupled to the connection conduit 444. The fluid valve 452 is disposed in-line with the suction conduit 434 to control the application of suction to the instrument body 410.

[0087] In some examples, as shown in FIGS. 5A-5D, the fluidics assembly 430 can include a fluid valve 552a-b configured to be connected between the fluid delivery assembly 436, the suction conduit 434 and the connection assembly 442 or directly with the medical instrument 406. With this configuration, actuation of the fluid valve 552a-b controls the application of suction through the lumen 412 of the instrument body 410, as well as the delivery of fluid through the lumen 412 of the instrument body 410, such as when the instrument body 410 is being robotically controlled within a patient via the input device 404.

[0088] The fluid valve 552a-b includes a valve body 554 having a first proximal opening 556 having the suction conduit 434 fluidly coupled thereto, a second proximal opening 557 having the fluid delivery assembly 436 fluidly coupled thereto, and a distal opening 558 having the connection assembly 442 fluidly coupled thereto. In some examples, the fluid valve 552a-b can include a removable bottom cap 580 that is secured to the valve body 554. As shown, the second proximal opening 557 can be defined by the bottom cap 580.

[0089] An actuation assembly 560 of the fluid valve 552a-b is movable from a first configuration preventing fluid flow between the first proximal opening 556 and the distal opening 558 to a second configuration allowing fluid flow between the first proximal opening 556 and thedistal opening 558 to apply suction force through the connection assembly 442 from the suction conduit 434. The fluid valve 552a-b is configured to be in the first configuration when no external force is applied to the actuation assembly 560 to preven t / restrict an unintended application of suction force through the connection assembly 442 from the suction conduit 434. In the first configuration, fluid can flow between the second proximal opening 557 and the distal opening 558. In the second configuration, fluid is prevented / restricted from flowing between the second proximal opening 557 and the distal opening 558.

[0090] In some examples, the fluid valve 552a-b can provide a leak path through a leak opening 562 defined in the valve body 554 for suction from the suction conduit 434 so that suction is not applied when not intended or such that no residual negative pressure is maintained inside the lumen of the body. The actuation assembly 560 includes a first seal 564, a second seal 566, and a third seal 567, where the first seal 564 prevents fluid flow (due to the vacuum source 440 or the fluid delivery assembly 436) between the first proximal opening 556 and the distal opening 558 in the first configuration, the second seal 566 seals the leak opening 562 in the second configuration, and the third seal 567 prevents fluid flow between the second proximal opening 557 and the distal opening 558 in the second configuration. The actuation assembly 560 further includes a spring 568 to bias the actuation assembly 560 to the first configuration.

[0091] As shown, the actuation assembly 560 can include a valve stem 570 movable between the first and second configurations, and the first, second, and third seals 564, 566, 567 can be coupled to the valve stem 570 to be moved thereby. The first seal 564 can be positioned to selectively engage and seal against a valve seat 572 defined in the valve body 554. The second seal 566 can be disposed adjacent to the leak opening 562 to selectively engage and seal against the valve body 554 around the leak opening 562. The third seal 567 can be disposed adjacent to the second proximal opening 557 to selectively prevent fluid flow therethrough.

[0092] While sharing the above configurations, the example fluid valves shown in FIGS. 5A- 5D also show different options for providing the third seal 567. For example, the third seal 567 can be stationary with respect to the valve stem 570 to be movable along therewith or the third seal 567 can be biased into sealing engagement around the second proximal opening 557.

[0093] The spring 568 can be operably coupled to the valve stem 570 to bias the first seal 564 into engagement with the valve seat 572 and space the second seal 566 from the leak opening 562 In some examples, as shown in FIGS. 5A-5B, the third seal 567 of the fluid valve 552a can bedisposed around the valve stem 570 and configured to engage an interior surface of the second proximal opening 557 defined by the bottom cap 580. With this configuration, the spring 568 extends between the bottom cap 580 and the valve stem 570 to bias the third seal 567 away from the second proximal opening 557.

[0094] In other examples, as shown in FIGS. 5C-5D, the actuation assembly 560 of the fluid valve 552b can include a floating member 573, where the spring 568 extends between the floating member 573 and the valve stem 570. The third seal 567 is coupled to the floating member 573 to be disposed between the floating member 573 and the bottom cap 580. With this configuration, the spring 568 always biases the third seal 567 into engagement with the bottom cap 580 to restrict or prevent fluid flow through the second proximal opening 557. With the actuation assembly 560 in the first configuration, the spring 568 is extended and, thus, exerts a smaller biasing force on the floating member 573 than when the spring 568 is in the second configuration. The dimensions of the fluid valve components and the configuration of the spring 568 can be configured so that a predetermined amount of force exerted by the fluid delivery assembly 436 can overcome the biasing force of the spring 568 in the first configuration to thereby deliver fluid through the distal opening 558. In some examples, the valve stem 570 and floating member 573 can be sized so that the valve stem 570 abuts the floating member in the second configuration to thereby prevent movement of the floating member 573 and the flow of fluid through the second proximal opening 557.

[0095] The actuation assembly 560 can extend through the leak opening 562 and include a button 574 disposed exteriorly to the valve body 554. The button 574 can be integral with the valve stem 570 or coupled thereto by any suitable method, such as welding, adhesive, friction fit, and so forth. To actuate the fluid valve 552a-b, the button 574 is pressed towards the valve body 554 which causes the first seal 564 to disengage from the valve seat 572 and the second seal 566 to engage the valve body 554 around the leak opening 562. As with the above examples, the button 574 can include the second seal 566 or the second seal 566 can be disposed adjacent to the button 574 between the button 574 and the leak opening 562.

[0096] The fluid valves 552a-b of these examples can also include a manipulation interface 576 with the button 574 and manipulation structure 578 on the fluid valve 552a-b to facilitate handling of the fluid valve 552. As shown, the manipulation structure 578 can be ribs to provide a texturedsurface for gripping. The ribs can have a convex or a concave configuration as discussed above. Alternatively, the bottom cap 580 can include the manipulation structure 578 as discussed above.

[0097] In any of the above examples, the medical system 400 can include a second fluidics assembly having any configuration as described above with respect to the first fluidics assembly 430. For example, the second fluidics assembly can include a suction conduit and a fluid delivery assembly having a delivery conduit. The second fluidics assembly can be configured to fluidly couple to the proximal port 416 of the medical instrument 406.

[0098] FIG. 6 is a simplified diagram of a medical system 600 according to some embodiments. According to some embodiments consistent with FIGS. 4A and 5A-5D, the medical system 600 may correspond to the medical system 400.

[0099] As shown, the medical system 600 includes an actuator 602 and dock 604 for robotic control of operation of the fluidics assembly 430. As described above, the fluidics assembly 430 can include the fluid valve 552a-b connected between the fluid delivery assembly 436 and the suction conduit 434 on one side and the connection assembly 442 and / or the medical system 400 on the other side.

[0100] The dock 604 includes at least a recess or cavity sized to receive the fluid valve 552a-b therein to align the fluid valve 552a-b (e.g., the actuation assembly 560 of the fluid valve 552a-b) with the actuator 602. The actuator 602 is coupled to the fluid valve 552a-b to control the actuation thereof between the first and second configurations. As shown, operation of the actuator 602 can be controlled by an input device 606. The input device 606 may be the input device 404, or may be a separate input device dedicated to controlling the actuator 602.

[0101] The fluid delivery assembly 436 shown in FIG. 6 may also include an actuator 608 for robotic control of operation of the fluid delivery device 450. The actuator 608 may be controlled using the input device 606 or a separate input device.

[0102] The medical system 600 may be configured for operator control of the input device 606 to actuate suction and fluid delivery. Alternatively or additionally, suction and fluid delivery actuators may be configured for automatic activation without user involvement, such as by the control system 112. In some examples, a medical instrument of the system 600 (e.g., medical instrument 104) may include an imaging device that is configured to capture images at a distal portion of the medical instrument as the medical instrument is being navigated in the patient. A control system (e.g., control system 112) of the medical system 600 can assess these images bysuitable computer vision and image detection algorithms to look for any mucus or fluids that may obstruct vision. Upon detection of mucus and / or fluids, the control system may be configured to automatically apply suction or fluid delivery in such cases to maintain a clear field of view for the user.

[0103] One or more components of the embodiments discussed in this disclosure, such as control system 112, may be implemented in software for execution on one or more processors of a computer system. The software may include code that when executed by the one or more processors, configures the one or more processors to perform various functionalities as discussed herein. The code may be stored in a non-transitory computer readable storage medium (e.g., a memory, magnetic storage, optical storage, solid-state storage, etc.). The computer readable storage medium may be part of a computer readable storage device, such as an electronic circuit, a semiconductor device, a semiconductor memory device, a read only memory (ROM), a flash memory, an erasable programmable read only memory (EPROM); a floppy diskette, a CD-ROM, an optical disk, a hard disk, or other storage device. The code may be downloaded via computer networks such as the Internet, Intranet, etc. for storage on the computer readable storage medium. The code may be executed by any of a wide variety of centralized or distributed data processing architectures. The programmed instructions of the code may be implemented as a number of separate programs or subroutines, or they may be integrated into a number of other aspects of the systems described herein. The components of the computing systems discussed herein may be connected using wired and / or wireless connections. In some examples, the wireless connections may use wireless communication protocols such as Bluetooth, near-field communication (NFC), Infrared Data Association (IrDA), home radio frequency (HomeRF), IEEE 802.11, Digital Enhanced Cordless Telecommunications (DECT), and wireless medical telemetry service (WMTS).

[0104] Various general-purpose computer systems may be used to perform one or more processes, methods, or functionalities described herein. Additionally or alternatively, various specialized computer systems may be used to perform one or more processes, methods, or functionalities described herein. In addition, a variety of programming languages may be used to implement one or more of the processes, methods, or functionalities described herein.

[0105] While certain embodiments and examples have been described above and shown in the accompanying drawings, it is to be understood that such embodiments and examples are merelyillustrative and are not limited to the specific constructions and arrangements shown and described, since various other alternatives, modifications, and equivalents will be appreciated by those with ordinary skill in the art.

Claims

What is claimed is:

1. A fluidics assembly for transferring fluids with a medical instrument, the fluidics assembly comprising: a connection assembly including a connection conduit; a suction conduit; a fluid delivery assembly including a delivery conduit; and a fluid valve fluidly coupled to the connection assembly, the suction conduit, and the fluid delivery assembly, the fluid valve including an actuation assembly movable between: a first configuration enabling fluid flow from the fluid delivery assembly to the connection assembly and restricting an application of suction force through the connection assembly from the suction conduit; and a second configuration applying suction force through the connection assembly from the suction conduit and restricting fluid flow from the fluid delivery assembly.

2. The fluidics assembly of claim 1, wherein the first configuration further provides a leak path for suction from the suction conduit and the second configuration seals the leak path.

3. The fluidics assembly of claim 1, wherein the supply conduit, the suction conduit, and the delivery conduit comprise flexible tubing.

4. The fluidics assembly of claim 1, wherein the actuation assembly of the fluid valve comprises a plurality of seals.

5. The fluidics assembly of claim 4, wherein the fluid valve comprises a valve stem movable between the first and second configurations, the plurality of seals being coupled to the valve stem.

6. The fluidics assembly of any one of claims 1 to 5, wherein the fluid valve comprises a manipulation interface including a button of the actuation assembly and manipulation structure on opposite sides of the fluid valve facilitating one-handed operation.

7. The fluidics assembly of claim 6, wherein the actuation assembly comprises a spring that biases the actuation assembly to the first configuration.

8. The fluidics assembly of any one of claims 1 to 5, wherein the fluid valve is in the first configuration when no external force is applied to the actuation assembly9. The fluidics assembly of any one of claims 1 to 5, wherein the fluid delivery assembly includes a fluid delivery device that provides fluid to the delivery conduit.

10. The fluidics assembly of any one of claims 1 to 5, wherein the fluid delivery assembly includes a flow control device preventing unwanted liquid flow through the delivery conduit.

11. The fluidics assembly of any one of claims 1 to 5, wherein the connection assembly further comprises a connector configured to couple the fluidics assembly to the medical instrument.

12. The fluidics assembly of claim 11 in combination with a medical instrument comprising a backend mechanism and a flexible elongate device including a lumen, the backend mechanism including a side port fluidly coupled to the lumen; wherein the connector is configured to couple to the side port to fluidly couple the fluidics assembly to the lumen.

13. The combination of claim 12, wherein the medical instrument comprises an actuator operably coupled to the actuation assembly of the fluid valve, the actuator configured to selectively move the fluid valve between the first and second configurations.

14. The combination of claim 13, wherein the medical instrument further comprises a dock configured to receive the fluid valve therein to align the actuation assembly with the actuator.

15. A robotic medical system comprising: a robotic drive system, an input device to command the robotic drive system, a flexible steerable instrument, including:a backend mechanism; and an instrument body extending from the backend mechanism, the instrument body including a lumen, the backend mechanism including a side port fluidly coupled to the lumen; and a fluidics assembly fluidly coupled to the side port of the backend mechanism to control fluid flow through the side port, the fluidics assembly comprising a fluid valve configured to be connected with a vacuum source such that actuation of the fluid valve controls application of suction through the lumen of the instrument body as the instrument body is robotically navigated in a patient via the input device.

16. The robotic medical system of claim 15, wherein the fluid valve comprises a valve body having a proximal opening and a distal opening, and an actuation assembly movable from a closed configuration preventing fluid flow between the proximal and distal openings to an open configuration allowing fluid flow between the proximal and distal openings, the fluid valve being in the closed configuration when no external force is applied to the actuation assembly.

17. The robotic medical system of claim 16, wherein the fluid valve comprises a manipulation interface including a button of the actuation assembly and manipulation structure on opposite sides of the valve body facilitating one-handed operation.

18. The robotic medical system of claim 15, wherein the fluidics assembly further comprises a fluid delivery assembly configured to supply fluid to the lumen of the instrument body through the side port, the fluid delivery assembly including a delivery conduit fluidly coupled to the fluid valve.

19. The robotic medical system of claim 18, wherein the fluid delivery assembly comprises a fluid delivery device supplying the fluid delivery assembly, the fluid delivery device being robotically actuated.

20. The robotic medical system of any one of claims 15 to 19, wherein the backend mechanism includes a proximal port configured to receive a medical tool for insertion within the lumen of the instrument body.

21. The robotic medical system of claim 20, wherein the backend mechanism further comprises a seal member configured to fluidly seal the proximal port.

22. The robotic medical system of claim 20, further comprising a second fluidics assembly configured to fluidly couple to the proximal port.

23. The robotic medical system of claim 22, wherein the second fluidics assembly comprises a suction conduit and a fluid delivery assembly including a delivery conduit.

24. The robotic medical system of claim 20, wherein the proximal port and the side port of the backend mechanism are orthogonal with respect to each other.

25. The robotic medical system of any one of claims 15 to 19, further comprising an actuator coupled to the fluid valve to control the actuation thereof, the actuator controlled by the input device.

26. The robotic medical system of claim 25, further comprising a dock configured to receive the fluid valve therein to align the fluid valve with the actuator.

27. The robotic medical system of any one of claims 15 to 19, wherein the fluid valve defines a suction leak opening configured to be manually covered to apply suction through the lumen of the instrument body.

28. The robotic medical system of any one of claims 15 to 19, further comprising a seal member configured to fluidly seal the side port when the fluidic assembly is detached from the side port.

29. The robotic medical system of any one of claims 15 to 19, wherein the fluidics assembly comprises: a connection assembly including a supply conduit; a suction conduit; and a fluid delivery assembly including a delivery conduit; wherein the fluid valve is fluidly coupled to the connection assembly, the suction conduit, and the fluid delivery assembly, the fluid valve including an actuation assembly movable between: a first configuration enabling fluid flow from the fluid delivery assembly to the connection assembly and restricting an application of suction force through the connection assembly from the suction conduit; and a second position applying suction force through the connection assembly from the suction conduit and restricting fluid flow from the fluid delivery assembly.

30. The robotic medical system of claim 29, wherein the fluid delivery assembly includes a flow control device preventing unwanted liquid flow through the delivery conduit.

31. The robotic medical system of claim 29, wherein the fluid delivery assembly includes a fluid delivery device that provides fluid to the delivery conduit.

32. The robotic medical system of any one of claims 15 to 19, wherein the instrument body comprises a flexible elongate device including an articulable body portion.

33. The robotic medical system of claim 32, wherein the flexible elongate device includes proximal and distal openings, the suction conduit for applying suction force through the distal opening of the flexible elongate device via the side port; and the fluid delivery assembly for delivering fluid through the distal opening of the flexible elongate device via the side port.

34. A medical system comprising: a medical instrument including: a backend mechanism; andan instrument body extending from the backend mechanism, the instrument body including a lumen, the backend mechanism including a side port fluidly coupled to the lumen; and a fluidics assembly that couples to the side port, the fluidics assembly including: a suction conduit for applying suction force; a fluid valve fluidly coupled to the suction conduit and actuatable to control application of suction force through the lumen of the instrument body; and a fluid delivery assembly for delivering fluid through the lumen of the instrument body via the side port.

35. The medical system of claim 34, wherein the fluid valve comprises: a valve body having a proximal opening and a distal opening; and an actuation assembly movable from a closed configuration preventing fluid flow between the proximal and distal openings to an open configuration allowing fluid flow between the proximal and distal openings, the fluid valve being in the closed configuration when no external force is applied to the actuation assembly.

36. The medical system of claim 35, wherein the fluid valve comprises a manipulation interface including a button of the actuation assembly and manipulation structure on opposite sides of the valve body facilitating one-handed operation.

37. The medical system of claim 34, wherein the fluid delivery assembly includes a delivery conduit fluidly coupled to the fluid valve.

38. The medical system of claim 37, wherein the fluidics assembly further comprises a connection assembly including a supply conduit and connector configured to couple the fluidics assembly to the side port, the fluid valve being fluidly coupled between the connection assembly, and the suction and fluid assemblies.

39. The medical system of claim 37, wherein the fluid delivery assembly includes a flow control device preventing unwanted liquid flow through the delivery conduit.

40. The medical system of claim 37, wherein the fluid delivery assembly includes a fluid delivery device that provides fluid to the delivery conduit.

41. The medical system of any one of claims 34 to 40, wherein the backend mechanism includes a proximal port configured to receive a medical tool for insertion within the lumen of the instrument body.

42. The medical system of claim 41, wherein the backend mechanism further comprises a seal member configured to fluidly seal the proximal port.

43. The medical system of claim 41, further comprising a second fluidics assembly configured to fluidly couple to the proximal port.

44. The medical system of claim 43, wherein the second fluidics assembly comprises a suction conduit including a suction conduit and a fluid delivery assembly including a delivery conduit.

45. The medical system of claim 41, wherein the proximal port and the side port of the backend mechanism are orthogonal with respect to each other.

46. The medical system of any one of claims 34 to 40, wherein the medical instrument further comprises an actuator operably coupled to the fluid valve to control the actuation thereof.

47. The medical system of claim 46, wherein the medical instrument further comprises a dock configured to receive the fluid valve therein to align the fluid valve with the actuator.

48. The medical system of any one of claims 34 to 40, wherein the fluid valve defines a suction leak opening configured to be manually covered to apply suction through the lumen of the instrument body.

49. The medical system of any one of claims 34 to 40, further comprising a seal member configured to fluidly seal the side port when the fluidic assembly is detached from the side port.

50. The medical system of any one of claims 34 to 40, wherein the instrument body comprises a flexible elongate device including an articulable body portion.

51. The medical system of claim 50, wherein the flexible elongate device includes proximal and distal openings, the suction conduit for applying suction force through the distal opening of the flexible elongate device via the side port; and the fluid delivery assembly for delivering fluid through the distal opening of the flexible elongate device via the side port.

52. A fluidics assembly for transferring fluids with a medical instrument, the fluidics assembly comprising: a connection assembly including a connection conduit; a suction conduit; a fluid delivery assembly including a delivery conduit fluidly coupled to the connection assembly; and a fluid valve fluidly coupled between the suction conduit and the connection assembly, the fluid valve including an actuation assembly movable between: a first configuration restricting an application of suction force through the connection assembly from the suction conduit; and a second configuration applying suction force through the connection assembly from the suction conduit and restricting fluid flow from the fluid delivery assembly.

53. The fluidics assembly of claim 52, wherein the first configuration provides a leak path for suction from the suction conduit and the second configuration seals the leak path.

54. The fluidics assembly of claim 52, wherein the supply conduit, the suction conduit, and the delivery conduit comprise flexible tubing.

55. The fluidics assembly of claim 52, wherein the actuation assembly of the fluid valve comprises a plurality of seals.

56. The fluidics assembly of claim 55, wherein the fluid valve comprises a valve stem movable between the first and second configurations, the plurality of seals being coupled to the valve stem.

57. The fluidics assembly of any one of claims 52 to 56, wherein the fluid valve comprises a manipulation interface including a button of the actuation assembly and manipulation structure on opposite sides of the fluid valve facilitating one-handed operation.

58. The fluidics assembly of claim 57, wherein the actuation assembly comprises a spring that biases the actuation assembly to the first configuration.

59. The fluidics assembly of any one of claims 52 to 56, wherein the fluid valve is in the first configuration when no external force is applied to the actuation assembly60. The fluidics assembly of any one of claims 52 to 56, wherein the fluid delivery assembly includes a fluid delivery device that provides fluid to the delivery conduit.

61. The fluidics assembly of any one of claims 52 to 56, wherein the fluid delivery assembly includes a flow control device preventing unwanted liquid flow through the delivery conduit.

62. The fluidics assembly of any one of claims 52 to 56, further comprising a hub having proximal connections fluidly coupled to the suction conduit and the delivery conduit and a distal connection fluidly coupled to the connection conduit.

63. The fluidics assembly of any one of claims 52 to 56, wherein the connection assembly further comprises a connector configured to couple the fluidics assembly to the medical instrument.

64. The fluidics assembly of claim 63 in combination with a medical instrament comprising a backend mechanism and a flexible elongate device including a lumen, the backend mechanism including a side port fluidly coupled to the lumen; wherein the connector is configured to couple to the side port to fluidly couple the fluidics assembly to the lumen.

65. The combination of claim 64, wherein the medical instrument comprises an actuator operably coupled to the actuation assembly of the fluid valve, the actuator configured to selectively move the fluid valve between the first and second configurations.

66. The combination of claim 65, wherein the medical instrument further comprises a dock configured to receive the fluid valve therein to align the actuation assembly with the actuator.

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