Backend mechanism of catheter control system

Abstract

To solve a problem of a conventional technique.SOLUTION: A backend mechanism of a control system for an operable medical tool includes an operation component configured to provide compact and reliable operation control with respect to an elongated medical tool, and a plurality of drive components.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] (Reference to Related Applications) This application claims the benefit of U.S. Provisional Application No. 62 / 671,958, filed May 15, 2018, the entire contents of which are incorporated herein by reference.

[0002] The present disclosure is directed to systems utilized in medical procedures and methods of operation used during those procedures. More specifically, the present disclosure is directed to back-end mechanisms of catheter control systems and related methods.

Background Art

[0003] Minimally invasive medical techniques are intended to reduce the amount of tissue damaged during a medical procedure, thereby reducing the patient's recovery time, discomfort, and adverse side effects. Such minimally invasive techniques may be performed through natural openings in the patient's anatomical structure or through one or more (one or more) surgical incisions. Through these natural openings or incisions, a physician may insert a minimally invasive medical device (including a surgical instrument, diagnostic instrument, treatment instrument, or biopsy instrument) to reach the target tissue location. One such minimally invasive technique is to use a flexible and / or steerable elongated device, such as a flexible catheter, that can be inserted into an anatomical passageway and navigated towards an area of interest within the patient's anatomical structure. Control of such an elongated device by medical personnel involves the management of several degrees of freedom, including at least the management of the insertion and withdrawal of the elongated device and the steering of the device. In addition, different operating modes may be supported.

[0004] A backend mechanism control system includes components that enable the manipulation or operation of an elongated device or an instrument extending through an elongated device. The backend mechanism control system then works with the elongated device to perform a surgical technique under the control of the healthcare provider. To increase the likelihood of a successful surgical outcome, it is desirable to provide a backend mechanism control system that is stable, compact, and removable for sterilization during use. Furthermore, it is desirable that the components of the backend mechanism control system controlling the elongated device provide predictable and repeatable actions for consistent results under the control of the surgeon. In addition, it is advantageous to provide a backend mechanism control system that provides control of a maneuverable elongated device, such as a maneuverable catheter, which may be suitable for use in minimally invasive techniques. [Overview of the project]

[0005] Generally, this disclosure is directed toward systems and methods for maneuvering elongated members using a backend mechanism that works in cooperation with a pull wire to be operably maneuvered via a motor. Additional specific embodiments of the invention are best summarized by the claims that follow this description.

[0006] In several exemplary implementations, the disclosure is directed toward a control system for an elongated member that is steerable via a pull wire. The control system may include a chassis that can be fixed in place on the elongated member during use, and a pulley supported by the chassis. The pulley may include a pull wire support surface structurally configured to support a pull wire. The pulley may be rotatable about a first axis. The control system may include a capstan supported by the chassis and rotatable about a second axis aligned at an angle with respect to the first axis. The capstan may have a pull wire support surface that allows the pull wire to wrap around the capstan.

[0007] In some embodiments, the chassis includes a pocket having an opening through which a pull wire extends. In some embodiments, the control system includes an input disk configured to drive a capstan into rotation. The input disk may include a shaft having a non-cylindrical shape, and the capstan may be configured to interface with the non-cylindrical shape in such a way that the shaft can rotate the capstan. In some embodiments, the capstan may include a helical groove configured to wind the pull wire without overlap. In some embodiments, the control system may include a rotation limiter configured to prevent the capstan from rotating beyond a threshold position. In some embodiments, the rotation limiter may include a mechanical stop configured to prevent the capstan from rotating beyond a threshold position.

[0008] In some embodiments, the control system may include an optical fiber connector extending from the chassis, and a shape-sensing optical fiber extending from the optical fiber connector through the length of an elongated member. The shape sensor may be configured to detect the shape of the elongated member. The optical fiber connector may be configured to communicate the information detected by the shape sensor. In some embodiments, the control system includes an enclosed housing, which includes a service loop adjacent to the walls of the housing. The housing may include an arcing surface sized to accommodate the bending of the shape sensor extending between a launch region fixture within the housing and the elongated member. In some embodiments, the service loop is a 180-degree bend in the shape sensor. In some embodiments, the housing includes a guide defining a guide slot through which the shape sensor extends. In some embodiments, the chassis includes an opening in the elongated member defining a third axis substantially parallel to a second axis. In some embodiments, the control system includes a coil pipe having a proximal end fixed to the chassis at a connection point. The proximal end of the coil pipe may be positioned substantially perpendicular to a third axis defined by an elongated member opening, and the pull wire may extend through the coil pipe to a pulley, and thereby to a capstan. In some embodiments, the chassis includes a mounting surface shaped and configured to interface with an instrument carriage configured to drive the capstan. The mounting surface may extend generally along the mounting plane and may have a first interface portion and a second non-interface portion, which are arranged side by side. The first interface portion may have a fiber connector and a rotary input member. The second non-interface portion may have a first elongated member opening formed such that an elongated member extends from the elongated member opening in a direction substantially perpendicular to the mounting plane.In some embodiments, the chassis includes a mounting surface having one of a plurality of V-shaped grooves and a plurality of locating mounts, and the fixture carriage includes the other of a plurality of V-shaped grooves and a plurality of locating mounts. The plurality of V-shaped grooves may be configured to receive the plurality of locating mounts.

[0009] In some embodiments, the control system includes a cover attached to the chassis at an interface to form a cavity within the chassis, and the pulley is positioned within the cavity. An input disk may be configured to pass through an opening in the chassis and rotatably drive the capstan. The input disk has a shielding surface to prevent the ingress of fluid.

[0010] In another exemplary embodiment, the disclosure is directed to a control system for an elongated member, comprising a housing that includes a plurality of steering components for steering the elongated member. The housing may have a mounting surface shaped and configured to interface with an instrument carriage configured to provide input to the steering components. The mounting surface may extend substantially along a mounting plane and have a first interface portion and a second non-interface portion, arranged in parallel. The first interface portion may have a fiber connector and a rotary input member, and the second non-interface portion may have a first elongated member opening formed such that the elongated member within the elongated member opening extends in a direction substantially perpendicular to the mounting plane.

[0011] In some embodiments, a kinematic mount is included, configured to selectively connect the housing to the instrument carriage at a uniquely determined position and orientation. In some embodiments, a control system may include a kinematic mount configured to selectively position and orient the housing relative to the instrument carriage. In some embodiments, the housing includes a plurality of latch connectors configured to selectively secure the housing to the instrument carriage. In some embodiments, each of the rotary input members on the mounting surface includes an input disk, which is mountable to an output disk on the instrument carriage and driven by the output disk on the instrument carriage, and the input disk communicates with a steering component. In some embodiments, the mounting surface includes either a printed circuit assembly or pogo pins, and the instrument carriage includes the other of a printed circuit assembly or pogo pins, and the circuit assembly is configured to communicate with the pogo pins.

[0012] In yet another exemplary embodiment, the disclosure is directed to a control system for maneuvering an elongated member including a housing, the housing including a chassis and a cover, the chassis and cover being sealed to each other by an interface to form a cavity therein, a plurality of maneuvering components for maneuvering the elongated member being located within the cavity, and the interface being sealed to prevent fluid ingress. A plurality of input disks may be configured to pass through an opening in the chassis and rotatably drive the maneuvering components, the input disks being shielded or sealed to prevent fluid ingress, or protected by a sealing cover to prevent fluid ingress, or protected by a sealing cover to prevent fluid ingress.

[0013] In some embodiments, the disclosure includes a connector for attaching the housing to an instrument carriage, the connector including a shield or seal to prevent fluid ingress. In some embodiments, the chassis includes a peripheral groove, and the cover has edges that seal-fit into the peripheral groove. In some implementations, sealing is achieved by welding.

[0014] In yet another exemplary embodiment, the disclosure is directed to a control system for steering an elongated member, including a chassis that includes a steering component support surface and an opposing mounting surface. The steering component support surface may support a capstan operably coupled to a pull wire configured to steering the elongated member. An input disk is located on the mounting surface and is configured to rotate the capstan to displace the pull wire. A fiber optic connector may be located on the mounting surface and extends from the mounting surface away from the steering component support surface, and the input disk and fiber optic connector are positioned to engage with the instrument carriage by the translation of the chassis that mounts the chassis to the instrument carriage.

[0015] Both the general statements above and the detailed statements below are essentially illustrative and descriptive, and should be understood as being intended to bring about an understanding of the disclosure without limiting its scope. In this regard, additional aspects, features, and advantages of the disclosure will be apparent to those skilled in the art from the detailed statements below. [Brief explanation of the drawing]

[0016] [Figure 1] This is a simplified diagram of a remotely operated medical system adjacent to a patient, according to several embodiments.

[0017] [Figure 2A] This is a simplified diagram of a medical device system according to several embodiments.

[0018] [Figure 2B] This is a simplified diagram of a medical device equipped with an extended medical tool according to several embodiments.

[0019] [Figure 3A] This is a simplified side view of a medical device attached to an insertion assembly according to several embodiments and positioned to treat a patient. [Figure 3B]A schematic side view of a medical device attached to an insertion assembly and positioned to treat a patient, according to some embodiments.

[0020] [Figure 4] A diagram of the backend mechanism of a medical device in a partially disassembled configuration according to some embodiments.

[0021] [Figure 5] A diagram of the backend mechanism of a portion of a medical device in a partially disassembled configuration according to some embodiments.

[0022] [Figure 6] A diagram of a portion of the housing of the backend mechanism of a medical device according to some embodiments.

[0023] [Figure 7] A cross-sectional view along line 7-7 of FIG. 6 of the housing according to some embodiments.

[0024] [Figure 8] A diagram of the backend mechanism of a medical device according to some embodiments.

[0025] [Figure 9] A diagram of a portion of the chassis of the backend mechanism of a medical device according to some embodiments.

[0026] [Figure 10] A diagram of the mounting surface of the chassis of the backend mechanism of a medical device according to some embodiments.

[0027] [Figure 11] A diagram of a drive component for the backend mechanism of a medical device according to some embodiments.

[0028] [Figure 12]This is a diagram of drive components in a disassembled configuration for a back-end mechanism of a medical device according to several embodiments.

[0029] [Figure 13] This is a diagram of a capstan for a back-end mechanism of a medical device according to several embodiments.

[0030] [Figure 14] This is a diagram of a partial assembly of the back-end mechanism of a medical device according to several embodiments.

[0031] [Figure 15] This is a diagram of a portion of the instrument carriage of a medical device according to several embodiments.

[0032] [Figure 16] This is a diagram of the back-end mechanism of a medical device according to several embodiments.

[0033] [Figure 17] This is a diagram of a portion of the chassis of a back-end mechanism of a medical device according to several embodiments.

[0034] [Figure 18] This flowchart shows an exemplary method for connecting the backend mechanism of a medical device to an insertion assembly according to several embodiments. [Modes for carrying out the invention]

[0035] The embodiments of this disclosure and their advantages are best understood by referring to the following detailed description. Equivalent reference numbers are used to identify equivalent elements illustrated in one or more of the figures, and it should be understood that those shown therein are for illustrative purposes only and not to limit the embodiments of this disclosure.

[0036] For the purpose of facilitating an understanding of the principles of this disclosure, embodiments illustrated in the drawings are used herein with reference and described using specific terminology. The following detailed description provides numerous specific details to give a complete understanding of the embodiments of the disclosure. However, it will be apparent to those skilled in the art that embodiments of this disclosure may be carried out without these specific details. In other cases, well-known methods, procedures, components, and circuits are not described in detail so as not to unnecessarily obscure aspects of the embodiments of the invention.

[0037] Any changes and further modifications to the described devices, apparatus, methods, and any further applications of the principles of this disclosure are fully assumed to be as normally conceivable to those skilled in the art relating to this disclosure. In particular, any configurations, components, and / or steps described in relation to one embodiment are fully assumed to be combined with configurations, components, and / or steps described in relation to other embodiments of this disclosure. In addition, the dimensions provided herein are for specific examples, and it is assumed that different sizes, dimensions, and / or proportions may be used to implement the concepts of this disclosure. To avoid unnecessary descriptive repetition, one or more components or actions described according to one exemplary embodiment may be used or omitted in a manner applicable from other exemplary embodiments. For the sake of brevity, numerous iterations of these combinations are not described separately. For the sake of brevity, in some examples the same or equivalent reference numerals are used throughout the drawings to refer to the same or similar parts.

[0038] This disclosure describes various instruments and parts thereof with respect to their states in three-dimensional space. As used herein, the term “position” refers to the location of an object or part of an object in three-dimensional space (e.g., three translational degrees of freedom along the Cartesian x, y, and z coordinates). As used herein, the term “orientation” refers to the rotational arrangement of an object or part of an object (e.g., three rotational degrees of freedom, such as roll, pitch, and yaw). As used herein, the term “pose” refers to the position of an object or part of an object in at least one translational degree of freedom and the orientation of an object or part of an object in at least one rotational degree of freedom (up to six degrees of freedom). As used herein, the term “shape” refers to a set of poses, positions, or orientations measured along an object.

[0039] Figure 1 is a simplified diagram of a remotely operated medical system 100 according to several embodiments. In some embodiments, the remotely operated medical system 100 is suitable for use, for example, in surgical procedures, diagnostic procedures, therapeutic procedures, or biopsy procedures. Several embodiments relating to such procedures are provided herein, but any references to medical devices or surgical instruments and medical methods or surgical methods are not limiting. The systems, devices, and methods described herein may be used for animals, human cadavers, animal cadavers, parts of human or animal anatomical structures, non-surgical diagnoses, and industrial systems and general robots or remotely operated systems.

[0040] As shown in Figure 1, the medical system 100 generally includes a manipulator assembly 102 for operating medical instruments 104 when performing various procedures on a patient P. The manipulator assembly 102 is mounted on or near the operating table T. A master assembly 106 allows an operator O (e.g., a surgeon, clinician, or physician as shown in Figure 1) to observe the intervention site and control the manipulator assembly 102.

[0041] The master assembly 106 may be located in the operator console, which is typically in the same room as the operating table T, such as beside the operating table where the patient P is placed. However, it should be understood that the operator O may be located in a different room or in an entirely different building from the patient P. The master assembly 106 generally includes one or more control devices for controlling the manipulator assembly 102. The control devices may include any number of different input devices, such as joysticks, trackballs, data gloves, trigger guns, manual controllers, voice recognition devices, body movement or presence sensors, and / or equivalents. To provide the operator O with a strong sense of direct control over the instrument 104, the control devices may have the same degrees of freedom as the associated medical instrument 104. In this way, the control devices provide the physician O with telepresence or the perception that the control devices are integrated with the medical instrument 104.

[0042] In some embodiments, the control device may have more or fewer degrees of freedom than the associated medical instrument 104, while still providing telepresence to the operator O. In some embodiments, the control device may optionally be a manual input device, which may have six degrees of freedom and include an operable handle for operating the instrument (e.g., closing gripping jaws, applying potential to electrodes, delivering medicinal treatment, and / or equivalent).

[0043] The manipulator assembly 102 supports the medical instrument 104 and may include one or more non-servo-controlled links (e.g., one or more links that may be manually positioned and locked in place, commonly referred to as a setup structure), and / or one or more servo-controlled links (e.g., one or more links that may be controlled in response to commands from a control system), and the kinematic structure of the remotely operated manipulator. The manipulator assembly 102 may optionally include a plurality of actuators or motors that drive inputs to the medical instrument 104 in response to commands from a control system (e.g., control system 112). The actuators may optionally include a drive system that, when coupled to the medical instrument 104, may advance the medical instrument 104 into an anatomically created or surgically constructed opening. Other drive systems may move the distal end of the medical instrument 104 with multiple degrees of freedom, which may include three degrees of linear motion (e.g., linear motion along the X, Y, and Z Cartesian axes) and three degrees of rotational motion (e.g., rotation about the X, Y, and Z Cartesian axes). In addition, actuators may be used to actuate an articulated end effector of the medical instrument 104 for grasping tissue within the jaws of a biopsy device or equivalent. Actuator position sensors, such as resolvers, encoders, potentiometers, and other mechanisms, may provide the medical system 100 with sensor data describing the rotation and orientation of the motor shaft. This position sensor data may be used to determine the movement of the object operated by the actuator.

[0044] The remotely operated medical system 100 may include a sensor system 108 having one or more subsystems for receiving information about the instrument of the manipulator assembly 102. Such subsystems may include a position / location sensor system (e.g., an electromagnetic (EM) sensor system), a shape sensor system for determining the position, orientation, speed, velocity, posture, and / or shape of the distal end and / or one or more segments along a flexible body that may constitute the medical instrument 104, and / or a visualization system for capturing images from the distal end of the medical instrument 104.

[0045] The remotely operated medical system 100 also includes a display system 110 that displays images or representations of the surgical site and medical instruments 104 generated by a subsystem of the sensor system 108. The display system 110 and the master assembly 106 may be oriented so that the operator O can control the medical instruments 104 and the master assembly 106 with telepresence perception.

[0046] In some embodiments, the medical device 104 may have a visualization system (discussed in more detail below) which may include a viewing scope assembly that records simultaneous or real-time images of the surgical site and provides the images to an operator or operator O through one or more displays of the medical system 100, such as one or more displays of the display system 110. The simultaneous images may be, for example, two-dimensional or three-dimensional images captured by an endoscope positioned within the surgical site. In some embodiments, the visualization system may include an endoscope component that is integrally or detachably coupled to the medical device 104. However, in some embodiments, a separate endoscope attached to a separate manipulator assembly may be used with the medical device 104 to image the surgical site. The visualization system may be implemented as hardware, firmware, software, or a combination thereof, which interacts with or is otherwise executed by one or more computer processors, which may include a processor of the control system 112.

[0047] The display system 110 may display images of the surgical site and medical instruments captured by the visualization system. In some examples, the remote medical system 100 may configure the control of the medical instrument 104 and the master assembly 106 such that the relative position of the medical instrument is similar to the relative position of the operator O's eyes and hands. In this way, the operator O can operate the medical instrument 104 and the hand control device as if viewing the workspace in a substantially true presence. True presence means that the image presentation is a true perspective image that simulates the viewpoint of a physician physically operating the medical instrument 104.

[0048] In some examples, the display system 110 may present images of the surgical site recorded preoperatively or intraoperatively using image data from imaging techniques such as computed tomography (CT), magnetic resonance imaging (MRI), fluoroscopy, thermography, ultrasound, optical coherence tomography (OCT), thermal imaging, impedance imaging, laser imaging, nanotube X-ray imaging, and / or equivalents. The preoperative or intraoperative image data may be presented as two-dimensional, three-dimensional, or four-dimensional images (including, for example, time-based or velocity-based information), and / or as images from a model created from the preoperative or intraoperative image dataset.

[0049] In some embodiments, often for the purpose of image-guided surgical procedures, the display system 110 may display a virtual navigation image in which the actual position of the medical instrument 104 is aligned (i.e., dynamically referenced) with a preoperative or simultaneous image / model. This may be done to present the operator O with a virtual image of the internal surgical site from the viewpoint of the medical instrument 104. In some examples, the viewpoint may be from the tip of the medical instrument 104. An image of the tip of the medical instrument 104 and / or other graphical or alphanumeric indicators may be superimposed on the virtual image to help the operator O control the medical instrument 104. In some examples, the medical instrument 104 may not be visible in the virtual image.

[0050] In some embodiments, the display system 110 may present the operator O with a virtual image of the medical instrument 104 within the surgical site from an external viewpoint by displaying a virtual navigation image in which the actual location of the medical instrument 104 is aligned with a preoperative or simultaneous image. An image of a portion of the medical instrument 104 or other graphical or alphanumeric indicator may be superimposed on the virtual image to assist the operator O in controlling the medical instrument 104. As described herein, a visual representation of data points may be rendered on the display system 110. For example, measured data points, moved data points, aligned data points, and other data points described herein may be displayed on the display system 110 in visual representation. Data points may be visually represented in the user interface as a plurality of points or dots on the display system 110, or as a rendered model such as a mesh or wire model created based on a set of data points. In some examples, data points may be color-coded according to the data they represent. In some embodiments, the visual representation may be refreshed in the display system 110 after each processing operation has been performed to modify the data points.

[0051] The remotely operated medical system 100 may include a control system 112. The control system 112 includes at least one memory and at least one computer processor (not shown) for providing control between the medical instrument 104, the master assembly 106, the sensor system 108, and the display system 110. The control system 112 includes programmed instructions (e.g., a non-temporary machine-readable medium for storing instructions) for performing some or all of the methods described in accordance with the embodiments disclosed herein, including instructions for providing information to the display system 110. Although the control system 112 is shown as a single block in the simplified diagram of Figure 1, the system may include two or more (two or more) data processing circuits, where one part of the processing is optionally performed in or adjacent to the manipulator assembly 102, another part of the processing is performed in the master assembly 106, and / or equivalent. The processor of the control system 112 may execute instructions, including instructions corresponding to the processes disclosed herein and described in more detail below. A wide variety of centralized or distributed data processing architectures may be used. Similarly, programmed instructions may be implemented as numerous separate programs or subroutines, or they may be integrated into numerous other embodiments of the remote control systems described herein. In one embodiment, the control system 112 supports wireless communication protocols such as Bluetooth®, IrDA, HomeRF, IEEE 802.11, DECT, and Wireless Telemetry.

[0052] In some embodiments, the control system 112 may receive force and / or torque feedback from the medical instrument 104. In response to the feedback, the control system 112 may transmit a signal to the master assembly 106. In some examples, the control system 112 may transmit a signal to one or more actuators of the manipulator assembly 102 to move the medical instrument 104. The medical instrument 104 may extend into an internal surgical site within the patient P through an opening in the patient P's body. Any suitable conventional and / or specialized actuator may be used. In some examples, one or more actuators may be separate from or integrated with the manipulator assembly 102. In some embodiments, one or more actuators and the manipulator assembly 102 are provided as part of a remotely operated cart positioned adjacent to the patient P and the operating table T.

[0053] The control system 112 may optionally further include a virtual visualization system to provide navigation assistance to operator O when controlling medical instruments 104 during image-guided procedures. Virtual navigation using the virtual visualization system may be based on referencing acquired preoperative or intraoperative datasets of anatomical passages. The virtual visualization system processes images of the surgical site acquired using imaging techniques such as computed tomography (CT), magnetic resonance imaging (MRI), fluoroscopy, thermography, ultrasound, optical coherence tomography (OCT), thermal imaging, impedance imaging, laser imaging, nanotube X-ray imaging, and / or equivalents. Using software which may be used in combination with manual input, the recorded images are converted into segmented two- or three-dimensional composite representations of partial or whole anatomical organs or regions. Image datasets are associated with the composite representations. The composite representations and image datasets describe various locations and shapes of passages, as well as their connectivity. Images used to generate the composite representations may be recorded preoperatively or intraoperatively during clinical procedures. In some embodiments, the virtual visualization system may use a standard representation (i.e., a non-patient-specific representation) or a hybrid of a standard representation and patient-specific data. The hybrid representation and any virtual images generated by the hybrid representation may represent a static position of a deformable anatomical region during one or more stages of motion (e.g., during the lung inspiratory / expiratory cycle).

[0054] During a virtual navigation procedure, the sensor system 108 may be used to calculate the approximate location of the medical instrument 104 relative to the anatomical structure of patient P. This location can be used to generate both macro-level (external) tracking images of the anatomical structure of patient P and virtual internal images of the anatomical structure of patient P. The system may implement one or more electromagnetic (EM) sensors, fiber optic sensors, and / or other sensors to align and display the medical instrument along with preoperatively recorded surgical images, such as those from a virtual visualization system. For example, Patent Document 1 ("Medical System Providing Dynamic Registration of a Model of an Anatomic Structure for Image-Guided Surgery") (filed May 13, 2011), which is incorporated herein by reference in its entirety, discloses one such system. The remotely operated medical system 100 may further optionally include optional operation and support systems (not shown), such as a lighting system, a control system, a cleaning system, and / or a suction system. In some embodiments, the remotely operated medical system 100 may include more than one remotely operated manipulator assembly and / or more than one master assembly. The exact number of remotely operated manipulator assemblies depends, among other factors, on the surgical procedure and spatial constraints within the operating room. The master assemblies 106 may be located in the same place, or they may be located in separate places. Multiple master assemblies allow more than one operator to control one or more remotely operated manipulator assemblies in various combinations.

[0055] Figure 2A is a simplified diagram of a medical device system 200 according to several embodiments. In some embodiments, the medical device system 200 may be used as a medical device 104 in an image-guided medical procedure performed by a remotely operated medical system 100. In some examples, the medical device system 200 may be used for exploratory procedures that are not remotely operated, or in procedures involving conventional manually operated medical devices such as endoscopes. Optionally, the medical device system 200 may be used to collect (i.e., measure) a set of data points corresponding to locations within the anatomical passages of a patient, such as patient P.

[0056] The medical device system 200 includes an elongated member 202, such as a flexible catheter, which is connected to a drive unit 204. In some embodiments, the drive unit 204 may be connected to or integrated within a manipulator assembly 102. The elongated member 202 includes a flexible body 216 having a proximal end 217 and a distal end 218. In some embodiments, the flexible body 216 has an outer diameter of about 3 mm. The outer diameter of other flexible bodies may be larger or smaller.

[0057] The medical device system 200 further includes a tracking system 230 for determining the position, orientation, speed, velocity, attitude, and / or shape of the distal end 218 and / or one or more segments 224 along the flexible body 216 using one or more sensors and / or imaging devices as described in more detail below. The entire length of the flexible body 216 between the distal end 218 and the proximal end 217 may be effectively divided into segments 224. If the medical device system 200 corresponds to the medical device 104 and tracking system 230 of the remotely operated medical system 100, the tracking system 230 may optionally be implemented as hardware, firmware, software, or a combination thereof that interacts with or is otherwise executed by one or more computer processors, which may include the processor of the control system 112 in Figure 1.

[0058] The tracking system 230 may optionally track one or more of the distal end 218 and / or segments 224 using a shape sensor 222. The shape sensor 222 may optionally include an optical fiber aligned with the flexible body 216 (for example, provided within an internal channel or lumen (not shown) or externally mounted). In one embodiment, the optical fiber has a diameter of about 200 μm. In other embodiments, the dimensions may be larger or smaller. The optical fiber of the shape sensor 222 forms an optical fiber bending sensor for determining the shape of the flexible body 216. In one alternative, an optical fiber including a fiber Bragg grating (FBC) is used to provide strain measurement in the structure in one or more dimensions. Various systems and methods for monitoring the shape and relative position of an optical fiber in three dimensions are described in Patent Document 2 (filed July 13, 2005) disclosing "Fiber optic position and shape sensing device and method relating thereto", Patent Document 3 (filed July 16, 2004) disclosing "Fiber-optic shape and relative position sensing", and Patent Document 4 (filed June 17, 1998) disclosing "Optical Fibre Bend Sensor", all of which are incorporated herein by reference in their entirety. In some embodiments, the sensor may utilize other suitable strain sensing techniques, such as Rayleigh scattering, Raman scattering, Burlien scattering, and fluorescence scattering. In some embodiments, the shape of an elongated member may be determined using other techniques. For example, the shape of the flexible body 216 over a time interval can be reconstructed using the history of the distal end orientation of the flexible body 216. In some embodiments, the tracking system 230 may optionally and / or additionally track the distal end 218 using the position sensor system 220.The position sensor system 220 may be a component of an EM sensor system comprising a position sensor system 220 including one or more conductive coils that may be exposed to an externally generated electromagnetic field. In this case, each coil of the EM sensor system generates an induced electrical signal having characteristics that depend on the position and orientation of the coil with respect to the externally generated electromagnetic field. In some embodiments, the position sensor system 220 may be configured and positioned to measure six degrees of freedom, for example, three position coordinates X, Y, Z and three orientation angles representing pitch, yaw, and roll of a base point, or five degrees of freedom, for example, three position coordinates X, Y, Z and two orientation angles representing pitch and yaw of a base point. Further descriptions of position sensor systems are provided in Patent Document 5 (filed August 11, 1999), which discloses "Six-Degree of Freedom Tracking System Having a Passive Transponder on the Object Being Tracked," and are incorporated herein by reference in their entirety.

[0059] In some embodiments, the tracking system 230 may, alternatively and / or additionally, rely on hierarchical posture, position, or orientation data stored for known points in the instrument system along a cycle of alternating motions, such as respiration. This stored data may be used to develop shape information relating to the flexible body 216. In some examples, a series of position sensors (not shown), such as electromagnetic (EM) sensors similar to the sensors in the position sensor 220, may be positioned along the flexible body 216 and then used for shape sensing. In some examples, particularly if the anatomical passages are largely static, the shape of the elongated member 202 may be represented using the history of data from one or more of these sensors taken during the procedure.

[0060] The flexible body 216 includes a channel 221 (Figure 2B) sized and shaped to receive a medical instrument 226. Figure 2B is a simplified diagram of the flexible body 216 with a medical instrument 226 extended according to several embodiments. In some embodiments, the medical instrument 226 may be used for procedures such as surgery, biopsy, excision, illumination, irrigation, or aspiration. The medical instrument 226 can be deployed through the channel 221 of the flexible body 216 and used at a target location within an anatomical structure. The medical instrument 226 may include, for example, an image capture probe, a biopsy instrument, a laser ablation fiber, and / or other surgical, diagnostic, or therapeutic tools. The medical tool may include an end effector having a single working member, such as a scalpel, a blunt blade, an optical fiber, an electrode, and / or equivalent. Other end effectors may include, for example, forceps, grapplers, scissors, clip applicators, needle drivers, retractors, stabilizers, and / or equivalents. Other end effectors may further include electrically activated end effectors such as electrosurgical electrodes, transducers, sensors, and / or equivalents. In various embodiments, the medical instrument 226 is a biopsy instrument used to remove a sample of tissue or cells from a target anatomical structure site. The medical instrument 226 may also be used within the flexible body 216 in conjunction with an image capture probe. In various embodiments, the medical instrument 226 may be an image capture probe including a distal portion equipped with a stereoscopic or planar camera at or near the distal end 218 of the flexible body 216 for capturing images (including video images), which are processed by a visualization system 231 for display and / or provided to a tracking system 230 to support tracking of one or more of the distal end 218 and / or segments 224. The image capture probe may include a cable connected to the camera for transmitting the captured image data. In some examples, the image capture instrument may be a bundle of optical fibers, such as a fiberscope, connected to the visualization system 231.The image capture device may be single or multi-spectrum, for example, capturing image data in one or more of the visible spectrum, infrared spectrum, and / or ultraviolet spectrum. Alternatively, the medical device 226 itself may be the image capture probe. The medical device 226 may be advanced through the opening of the channel 221 to perform a procedure and retracted into the channel when the procedure is complete. The medical device 226 may be removed from the proximal end 217 of the flexible body 216 or from another optional instrument port (not shown) along the flexible body 216.

[0061] The medical instrument 226 may additionally accommodate a cable, linkage, or other actuation control device (not shown) extending between its proximal and distal ends to controllably bend the distal end of the medical instrument 226. Maneuverable instruments are described in detail in Patent Document 6 (filed October 4, 2005) disclosing "Articulated Surgical Instrument for Performing Minimally Invasive Surgery with Enhanced Dexterity and Sensitivity") and Patent Document 7 (filed September 30, 2008) disclosing "Passive Preload and Capstan Drive for Surgical Instruments"), which are incorporated herein by reference in their entirety. In some embodiments, the medical instrument 226 may include an end effector, such as those described above, fixed to the distal end of the medical instrument 226 or to an articulated wrist integrated with the distal end of the medical instrument 226. The operation of the end effector (e.g., gripping, pinching, and / or cutting operations) may be controlled using cables, linkages, or other actuation control devices, or the positioning of the end effector may be controlled via an articulated list. Such cables, linkages, or other actuation control devices may be terminated in and controlled by mechanisms within a drive unit, such as drive unit 204.

[0062] The flexible body 216 may house cables, linkages, or other steering control devices (not shown) extending between the drive unit 204 and the distal end 218 to controllably bend the distal end 218, for example, as shown by the dashed line drawing 219 of the distal end 218. In some examples, at least four cables are used to independently provide “up and down” steering for controlling the pitch of the distal end 218 and “left and right” steering for controlling the yaw of the distal end 218. An operable elongated member is described in detail in Patent Document 8 (filed October 14, 2011) (disclosing “Catheter with Removable Vision Probe”), which is incorporated herein by reference in its entirety. In embodiments in which the medical device system 200 is operated by a remote operation assembly, the drive unit 204 may include a drive input unit that is detachably coupled to a drive element such as an actuator of the remote operation assembly and receives power from such a drive element. In some embodiments, the medical device system 200 may include a gripping configuration, a manual actuator, or other components for manually controlling the movement of the medical device system 200. The elongated member 202 may be maneuverable, or alternatively, the system may be non-maneuverable without an integrated mechanism for operator control of bending of the distal end 218. In some examples, one or more lumens are defined in the wall of the flexible body 216 that can be deployed and used at the target surgical site.

[0063] In some embodiments, the medical device system 200 may include flexible bronchial instruments, such as a bronchoscope or bronchial catheter, for use in the examination, diagnosis, biopsy, or treatment of the lungs. The medical device system 200 is also suitable for the navigation and treatment of other tissues via naturally or surgically created connected passages in any of the various anatomical systems, including the colon, intestines, kidneys and renal calyces, brain, heart, circulatory system including the vascular system, and equivalent organs.

[0064] Information from the tracking system 230 may be transmitted to the navigation system 232, which, combined with information from the visualization system 231 and / or a preoperatively obtained model, provides real-time positional information to the physician or other operator. In some examples, the real-time positional information may be displayed on the display system 110 of Figure 1 for use in controlling the medical instrument system 200. In some examples, the control system 116 of Figure 1 may utilize the positional information as feedback for positioning the medical instrument system 200. Various systems for using optical fiber sensors to align and display surgical instruments with surgical images are provided in Patent Document 1, which is incorporated herein by reference in its entirety.

[0065] In some examples, the medical device system 200 may be remotely controlled within the medical system 100 in Figure 1. In some embodiments, the manipulator assembly 102 in Figure 1 may be replaced by direct operator control. In some examples, direct operator control may include various handles and operator interfaces for handheld operation of the device.

[0066] Figures 3A and 3B are simplified side views of a medical instrument attached to an insertion assembly and a position for treating a patient, according to several embodiments. As shown in Figures 3A and 3B, the surgical environment 300 includes a patient P positioned on the operating table T in Figure 1. The patient P may be stationary within the surgical environment in the sense that the patient's macroscopic movements are restricted by sedation, restraint, and / or other means. Periodic anatomical movements of the patient P, including breathing and cardiac movements, may continue unless the patient is asked to hold their breath and temporarily suspend respiratory movements. Thus, in some embodiments, data may be collected, tagged, and identified at specific phases of respiration. In some embodiments, the phase at which data is collected may be inferred from physiological information collected from the patient P. Within the surgical environment 300, a backend mechanism 304 can be detachably coupled to the instrument carriage 306. In some embodiments, the backend mechanism 304 may be formed by housing actuation components for cables used to independently provide vertical steering for controlling the pitch of the distal end 318 and horizontal steering for controlling the yaw of the distal end 318. In addition, the backend mechanism 304 may include an EM sensor, a shape sensor, and / or other sensor modalities, and / or provide connectors for connecting the sensing modalities to an instrument such as an elongated member 310.

[0067] The instrument carriage 306 can be attached to an insertion stage 308 which is fixed within the surgical environment 300. Alternatively, the insertion stage 308 may be movable but may have a known location within the surgical environment 300 (e.g., via a tracking sensor or other tracking device). The instrument carriage 306 may be a component of a remotely operated or non-remotely operated manipulator assembly (e.g., manipulator assembly 102) that controls the insertion motion (i.e., motion along the A-axis) and, optionally, the motion of the distal end 318 of the elongated member 310 in multiple directions, including yaw, pitch, and roll. The instrument carriage 306 or the insertion stage 308 may include actuators such as a servo motor (not shown) that control the motion of the instrument carriage 306 along the insertion stage 308, control the motion of the distal end 318 of the elongated member 310 in yaw / pitch, and / or control the roll motion of the elongated member 310 along the longitudinal axis.

[0068] The elongated member 310 is connected to a backend mechanism 304. The backend mechanism 304 is connected to and fixed to an instrument carriage 306. In some embodiments, an optical fiber shape sensor 314 is fixed to a proximal point 316 on the backend mechanism 304. In some embodiments, the proximal point 316 of the optical fiber shape sensor 314 may be movable with the backend mechanism 304, but the location of the proximal point 316 may be known (for example, via a tracking sensor or other tracking device). The shape sensor 314 measures the shape from the proximal point 316 to another point, such as the distal end 318 or a point along the distal portion of the elongated member 310.

[0069] The position measuring device 320 provides information regarding the position of the backend mechanism 304 as the backend mechanism moves along the insertion axis A on the insertion stage 308. The position measuring device 320 may include resolvers, encoders, potentiometers, and / or other sensors that control the operation of the instrument carriage 306 and consequently determine the rotation and / or orientation of actuators that control the operation of the backend mechanism 304. In some embodiments, the insertion stage 308 is linear. In some embodiments, the insertion stage 308 may be curved or have a combination of curved and linear sections.

[0070] Figure 3A shows the backend mechanism 304 and instrument carriage 306 in a retracted position along the insertion stage 308. In this retracted position, the proximal point 316 is at position L0 on axis A. In this position along the insertion stage 308, the components of the location of the proximal point 316 may be set to zero and / or another reference value to provide a base reference that describes the position of the instrument carriage 306 on the insertion stage 308, and thus the position of the proximal point 316. Using this retracted position of the backend mechanism 304 and instrument carriage 306, the distal end 318 of the elongated member 310 may be positioned proximal to the patient, for example, just inside, just outside, or in other proximity to the patient P's inlet orifice. In this position, the position measuring device 320 may also be set to zero and / or another reference value (e.g., I=0). In Figure 3B, the backend mechanism 304 and instrument carriage 306 are advancing along the linear trajectory of the insertion stage 308, and the distal end 318 of the elongated member 310 is advancing into the patient P. At this advanced position, the proximal point 316 is at position L1 on axis A. In some examples, encoder and / or other position data from one or more actuators that control the movement of the instrument carriage 306 and / or one or more position sensors associated with the instrument carriage 306 and / or insertion stage 308 along the insertion stage 308 are used to determine the position L of the proximal point 316 relative to position L0. x Used to determine the position L. xThe distal end 318 of the elongated member 310 may be further used as an indicator (index) of the distance or depth of insertion into the passage of the patient P's anatomical structure.

[0071] In Figure 3A, the backend mechanism 304 includes a mounting face 460 that may define a mounting plane. A portion of the mounting face 460, called the interface area, is positioned relative to the fixture carriage 306, while another portion, called the non-interface area, protrudes outward beyond the edge of the fixture carriage 306. As can be seen, the elongated member 310 extends from the backend mechanism 304, goes beyond the mounting face 460, and extends beyond the fixture carriage 306.

[0072] Figures 4, 5, and 8 are perspective views of the backend mechanism 304, independent of the instrument carriage 306 from Figures 3A and 3B, and including the proximal portion 319 of the elongated member 310. Figure 4 shows the backend mechanism 304 in a partially disassembled state, and Figure 5 shows a portion of the backend mechanism 304 in a more completely disassembled state. Figure 8 shows the assembled backend mechanism 304 with a portion of the housing 400 transparent. Referring to these figures, the backend mechanism 304 includes a housing 400, which includes a cover 402 and a chassis 404. For ease of visualization, the cover 402 is not shown in Figure 5. The chassis 404 carries several steering components 406, several drive components 408, a support fixture 410, a fiber connector 412, and a launch region fixture 414. The proximal portion 319 of the elongated member 310 extends through the housing 400 and terminates within the housing 400. Figures 4 and 5 also show a shape sensor 314 extending from the proximal portion 319 of the elongated member 310 to a firing area fixture 414, and a plurality of coil pipes 417 comprising pull wires 416 (tension wires) positioned within the plurality of coil pipes extending from the elongated member. The coil pipes 417 and pull wires 416 also extend from the elongated member 310 to a plurality of control components 406. The housing 400, including the cover 402 and chassis 404, is selectively mountable to the instrument carriage 306 (Figures 3A and 3B) and provides a compact, manageable unit that safely protects the control and sensing components from the surgical environment. In some implementations, the coil pipes 417 may have a terminal proximal end that is fixed to the support fixture 410. The pull wire 416 extends through the lumen within the coil pipe 417, extends from the proximal end of the coil pipe 417, and routes around the steering component 406 and the drive component 408.

[0073] The cover 402 is shown in Figures 4, 6, and 7. Figure 6 shows the cover 402 in a transparent view, independent of the chassis and the components supported by the chassis. Figure 7 shows a cross-sectional view of the cover 402 taken along line 7-7 in Figure 6. The cover 402 may include a cavity 430 sized and configured to cover and protect the steering component 406, the drive component 408, and other components supported by the chassis 404. The opening 432 to the cavity 430 is defined by a rim 433 shaped to interface with the chassis 404. In the illustrated implementation, the cover 402 includes a projecting boss 436 extending in the opposite direction from the opening 432. In this implementation, the projecting boss 436 includes a passage 438 through which an elongated member 310 may extend. Some exemplary implementations of the protruding boss 436 include one or more helical thread-like connection configurations that cooperate with corresponding connection configurations, such as threads, on a portion of the elongated member 310. Referring to Figures 4 and 5, the elongated member 310 is shown to include a locking connector 442 on its proximal portion 319. In some embodiments, the locking connector 442 is a Luer fitting or other connector positioned to interface with the proximal portion 319 of the elongated member 310. The locking connector 442 may allow connection to other medical device components.

[0074] In the illustrated implementation, the cover 402 includes an internally curved service loop guide slot 444 that guides and restrains the shape sensor 314 as it is molded to form a service loop 434 (Figure 8), while allowing for variable length or slack of the shape sensor from the firing area fixture 414 to the proximal portion 319 of the elongated member 310. In other words, the internal guide slot 444 provides variable radius and height of the service loop 434 of the shape sensor 314. The variable slack occurs because, as the catheter bends, the fiber is positioned away from the centerline of the elongated member or the neutral axis of the bend, allowing the fiber to nest in and out of the lumen of the elongated flexible shaft. Depending on the implementation, it may be important for shape sensing accuracy that the shape sensor 314, which may be an optical fiber as described above, is not subjected to sharp bends within its shape sensing area. In addition, the shape sensor may fail if bent at a sharp radius. In some implementations, the service loop 434 may extend from the firing area mounting fixture 414, enter the proximal portion 319 of the elongated member 310 through the guide slot 444, and reach the distal end 318 of the elongated member 310 (Figures 3A and 3B). In some implementations, severe bending may interfere with the measurable strain element of the shape sensor 314 portion forming the service loop 434, resulting in less accurate and predictable sensing of the data. Similarly, this may lead to reduced accuracy in determining the location of the distal end of the elongated member 310.

[0075] An internal guide slot 444 of the cover 402 supports the service loop 434 in a smooth, sufficiently sized arc, from which the service loop 434 curves to exit the proximal portion 319 of the elongated member 310 and terminate within the launch area fixture 414. In this implementation, the internal guide slot 444 allows the service loop 434 to curve 180° from the elongated member to the launch area fixture 414. Thus, as best seen in Figure 7, the guide slot 444 guides the service loop 434 along a smooth arc surface 446 where the shape sensor 314 may be positioned. In some implementations, the shape sensor 314 may be naturally biased toward a linear configuration. Thus, the service loop 434 may curve from the launch area fixture 414 to the elongated member 310. In the illustrated implementation, the internal guide slot 444 is also partially defined by one or more stabilizing guides or stabilizing guide rib sets 448. The illustrated implementation includes two stabilizing guide rib sets 448 spaced apart along an arcuate surface 446 within the cavity 430. The stabilizing guide rib sets 448 form a narrow opening in a guide slot 444 through which a service loop 434 may extend. In some implementations, the narrow opening may have a width only slightly larger than the diameter of the shape sensor 314. In this way, the shape sensor 314 may be held in place while minimizing lateral movement of the shape sensor 314 in a manner that could interfere with or reduce the accuracy of the measured position of the elongated member 310. Here, the stabilizing guide rib sets 448 have minimal thickness and extend from the arcuate surface 446 toward the opening 432 in the cover 402. In some implementations, the cover 402 is molded to provide a fin, which accommodates the service loop 434. In some implementations, the service loop 434 is asymmetrical. In some implementations, the guide slot 444 and the arc-shaped surface 446 work in cooperation with the elongated member 310 and the firing area mounting fixture 414 to maintain a shape sensor having a loop with a minimum arc angle of 180°. Implementations with a 180° arc angle may align the fiber connector and the elongated member so that they are parallel to each other. Thus, the connection of the backend mechanism may be simplified.This is because the operator simply pushes in the elongated member 310, then engages the fiber connector 412, and then pushes in the kinematic mount (described below). In some implementations, the formed loop may have an arc angle greater than 180°. For example, depending on the implementation, the loop may fall within an arc angle range of 90 to 270 degrees, but other arc ranges, both larger and smaller arcs, are conceivable. Some alternative embodiments may have a fiber connector perpendicular to the catheter input, in which case the arc angle may be about 90 degrees.

[0076] In some implementations, the cover 402 may function as a handler gripping surface for the backend mechanism 304. Therefore, the cover 402 may be molded and sized for convenient gripping by a human hand.

[0077] The chassis 404 is configured to support components of the backend mechanism 304. For example, the chassis 404 may support a steering component 406, a drive component 408, a support fixture 410, a fiber connector 412, and a launch area fixture 414. The chassis 404 may include a mounting surface 460 and an opposing steering component support surface 462. Multiple openings extend through the chassis 404 from the steering component support surface 462 to the mounting surface 460. For example, the chassis 404 includes an elongated member opening 464, a drive component opening 466, and a fiber connector opening 468. The elongated member 310 extends through the elongated member opening 464, the drive component 408 extends through the drive component opening 466, and the fiber connector 412 extends through the fiber connector opening 468. These openings may be used to provide electrical or mechanical connections between components forming the outer portion of the backend mechanism 304 and components located within the housing 400 of the backend mechanism 304. The mounting surface 460 may be configured to interface with the fixture carriage 306. In some implementations, the fixture carriage 306 may include a drive mechanism such as a drive motor, which may include pins or other connectors that interface with the drive component 408 of the backend mechanism 304, drive the drive component 408 of the backend mechanism 304, and provide a telecommunications interface that may interface with, for example, a printed circuit assembly 806 (Figure 10).

[0078] Figure 9 shows the steering component support surface 462 in more detail. Referring to both Figure 5 and Figure 9, the steering component support surface 462 includes a plurality of protruding bosses and a configuration shaped and configured to support the steering component 406, the drive component 408, and the support fixture 410. In this implementation, the steering component support surface 462 includes support projections 472, each support projection supporting a portion of the steering component 406. As best seen in Figure 9, in this implementation, the support projections 472 may consist of a pair of walls 473a, 473b separated by a gap 474. The walls 473a, 473b each include a trough 475 sized and shaped to support a pulley spindle, and the pulley wheel 486 may be positioned within the gap 474, as described later.

[0079] In the illustrated implementation, the support projection 472 is positioned adjacent to one of the drive component openings 466. Each drive component opening 466 is surrounded by a circular wall of the chassis 404 that forms a pocket 476. The pocket 476 stabilizes and secures a component, such as a drive component 408, in place. The circular wall forming the pocket has an inner diameter sized to cooperate with at least a portion of the steering component 406 to prevent the pull wire from being freely pulled or detached from the steering component, as will be discussed below. In this implementation, each pocket 476 includes a slit 477 sized to be wide enough for one of the pull wires 416 to pass through. The slit 477 faces or is aligned with the gap 474 between the walls 473a, 473b of the support projection 472. It also faces an alignment projection 478. The alignment projection 478 includes a slit 478a aligned with the slit 477 for the passage of the pull wire. It is molded to fit adjacent to the wheel of the pulley and is configured to prevent the pull wire from coming off the pulley even when the pulley may loosen. In this implementation, the alignment projection 478 is molded to fit into a groove in the pulley, while allowing the pull wire to extend from the pulley and through the slit 478a of the alignment projection 478 and through the slit 477 to reach the capstan that forms part of the drive component 408.

[0080] The front wall 479 is positioned between the elongated member opening 464 and other openings. In the illustrated implementation, the steering component support surface 462 of the chassis 404 includes a peripheral groove 480 that may receive the edge 433 of the cover 402. In some embodiments, the peripheral groove 480 and the edge 433 may cooperate to shield or seal and prevent fluid from entering the housing 400. In other implementations, the chassis 404 may include a protruding edge, and the cover 402 may include a receiving groove that receives the protruding edge of the chassis. Other shielding or sealing configurations are conceivable.

[0081] The steering component 406 is configured to direct a pull wire 416 extending from an elongated member 310 to a drive component 408. The pull wire 416 may be tightened or loosened axially to displace the distal end 318 of the elongated member 310, as described above. Each steering component 406 includes a pulley 484 comprising a wheel 486 and a spindle 488. In this implementation, the spindle is positioned substantially perpendicular to the axis of the proximal portion 319 of the elongated member 310, where the spindle 488 defines the axis on which the wheel 486 rotates. The wheel 486 may be formed of a low-friction pulley material to allow free rotation around the spindle 488. In some implementations, the low-friction pulley material is a metal such as stainless steel or aluminum with a low-friction bearing, while in other embodiments, the low-friction pulley material is a polymer material, not limited to polyethylene terephthalate (PET), acetal (POM), polyamide, and others, all of which may optionally be reinforced with a composite or applied lubricant such as PTFE, silicone oil, paraffin wax, and others. The wheel 486 may include a deep V-shaped pull wire support surface, illustrated and referred to herein as a groove 489, configured to re-enter the slack loop in the pull wire, including when the slack loop deviates from the pulley groove centerline beyond the outer wall of the pulley wheel. In addition, the groove 489 may be wide to aid in capture. In some implementations, slack in the pull wire may occur between bends of the elongated member 310. The width of the groove 489 may reorient the pull wire onto the wheel 486, even if the slack temporarily removes the pull wire from the groove 489. In some implementations, the pull wire may have a diameter in the range of approximately 0.015 to approximately 0.003 inches. The groove 489 may have a width of approximately 0.070 to approximately 0.250 inches, although larger or smaller grooves are conceivable. In some embodiments, the ratio of the pull wire diameter to the groove is approximately 27 to 1. In some implementations, the width of the groove 489 may be in the range of approximately 10% to approximately 30% of the diameter of the wheel 486. However, other diameters, widths, and ratios are conceivable.In some implementations, the pull wire may have a bend that causes lateral displacement when the pull wire has slack. A wide groove may help re-engage the pull wire into the groove 489. The groove 489 may be aligned with a tangent reference line intersecting the axis of the elongated member 310, or it may be offset from it. The spindle 488 may be supported at each end on the support projection 472 of the chassis 404. Some implementations of the groove 489 are V-shaped. Some of these implementations may include a 90° V-shaped groove. Other implementations may include a V-shaped groove with an angle that may be between approximately 45° and 135°. Further variations are conceivable. The groove 489 may be sized to be wide enough so that any slack on the wire automatically returns to and stays on the wire. In some implementations, the ratio of the pitch diameter of the groove 489 to the diameter of the pull wire may be in the range of approximately 35:1 to approximately 10:1. However, other size ratios are conceivable.

[0082] The drive component 408 (Figure 5) may interface with the pull wire 416 and may be driven by a motor on the instrument carriage 306. Thus, the drive component 408 may increase and decrease the tension in the pull wire 416, resulting in movement at the distal end 318 of the elongated member 310. In the illustrated implementation, each drive component 408 may include an input disk 500 with an axially extending shaft 510, a capstan 504, and a rotation limit ring 516. In some implementations, a centrally located locking shaft 506 extends through the central openings of the axially extending shaft 510 and the capstan 504.

[0083] Figures 11 to 13 show the drive component 408 in more detail. Figure 10 shows a perspective bottom view of the backend mechanism 304 with the input disk 500 easily visible. Figure 11 shows a single drive component 408 including the input disk 500 and capstan 504 in an assembled state. Figure 12 shows a single drive component 408 including the input disk 500 and capstan 504 in a disassembled state. Figure 13 shows the capstan 504 separate from the other drive components.

[0084] Referring to these figures, the input disk 500, sometimes called the input component, is configured to interface with a corresponding output disk (not shown) on the instrument carriage 306 (Figures 3A and 3B). The input disk 500 may include a head 508 and an axially extending shaft portion 510. The shaft portion 510 extends from the head 508. In this implementation, the shaft portion 510 extends from the outside of the housing 400 through a drive component opening 466 of the chassis 404 to the steering component support surface 462 of the chassis 404. The head 508 of the input disk 500 may be located on a mounting surface 460 of the chassis 404 and may be coupled to an output disk on the instrument carriage 306. By coupling the head 508 to the output disk on the instrument carriage 306, the rotation of a motor on the instrument carriage 306 may result in the corresponding rotation of the input disk 500 and the drive component 408.

[0085] In some embodiments, the input disk 500 includes a bottom surface 514 configured to interface with and engage with the corresponding output disk surface on the instrument carriage 306, thereby applying torque from the output disk to the drive component 408. Depending on the implementation, the bottom surface 514 may have configurations that mechanically engage with the output disk, such as pockets, recesses, splines, projections, or other configurations that may be used to apply torque to the drive component 408. The head 508 of the input disk 500 may also shield the shaft portion 510 and bearing 524 (Figure 12) from fluid ingress. Additional shielding may result from the shape and degree to which the mounting surface 460 of the chassis 404 engages with the instrument carriage 306 when the mounting surface 460 of the chassis 404 is attached to the instrument carriage 306.

[0086] Some implementations of the input disk 500 include an axially extending rotation limiter 512. The rotation limiter 512 stops the reverse rotational motion of the input disk 500 beyond a threshold position that could bend or break the pull wire 416. In the illustrated implementation, the rotation limiter 512 is a projection extending upward from the head 508 toward the shaft portion 510. As the input disk 500 rotates toward the shaft portion 510, the rotation limiter 512 may engage with a corresponding projection rotation stop 518 on the rotation limit ring 516. The rotation limiter 512 and the rotation limit ring 516 may be positioned to prevent excessive rotation in either the forward or reverse direction in a manner that allows sufficient rotation to provide steering by tensioning or untensioning the pull wire, while potentially applying excessive stress to weak points. Specifically, the rotation limiter 512, together with the rotation limiting ring 516, limits the rotation to protect the mechanism while allowing more rotations than one of the input disks 500. Furthermore, the input rotation limiter 512 may protect the pull wire and internal mechanism from rotation of the input while the backend mechanism 304 is disconnected from the motor output on the instrument carriage 306. The rotation limiter and limiting ring also protect the pull wire and mechanism when the backend mechanism is removed from the instrument carriage 306 while motor torque is applied to one or more of the input disks 500.

[0087] As best seen in Figure 11, the protruding rotation stop 518 on the rotation limiting ring 516 has a thickness or height greater than the height of the rotation limiter 512. The rotation limiter 512 may have a height that is selected to mechanically engage with the protruding rotation stop 518 without mechanically engaging with a rotation stop fixed to or forming part of the chassis 404. In contrast, the protruding rotation stop 518 may be sized and positioned to engage with both the rotation limiter 512 fixed to or forming part of the chassis 404 and the rotation limiter 512. Since the rotation limiting ring 516 may be rotated approximately 360° relative to the chassis 404 before engaging with the rotation stops on the chassis 404, and since the input disk 500 may be rotated approximately 360° relative to the rotation limiting ring 516, the overall rotation allowed by the input disk 500 relative to the chassis may be greater than 360° and less than 720°. The amount of rotation allowed by the rotation stop configuration may be changed by adjusting the circumferential thickness of the rotation limiter 512 and the protruding rotation stop 518.

[0088] In addition, the rotation limiter 512 may protect the pull wire from rotation of the input disk while the device is disconnected from the motor output. The rotation limiter 512 may also protect the pull wire 416 from recoil-induced reverse bending if the input disk 500 is disengaged from the device carriage 306 while the motor is applying torque to the input. In some implementations, the rotation limiter may also help prevent the pull wire from derailing from the groove 540 of the capstan 504.

[0089] The axially extending shaft portion 510 extends from the head 508 and includes a cylindrical portion 520 and a non-cylindrical portion 522. A bearing 524 may be positioned around the cylindrical portion 520. The capstan 504 may be positioned around the non-cylindrical portion 522. The non-cylindrical portion 522 may ensure that the capstan 504 is rotatably fixed to the input disk 500. In Figure 12, the non-cylindrical portion 522 has a hexagonal shape, but other polygons, splines, star polygons, and other non-cylindrical shapes may be used and are conceivable.

[0090] Figure 13 shows the capstan 504. The capstan 504 includes a cylindrical outer surface 530, a non-cylindrical inner surface 532, and an end surface 534. As described above, the non-cylindrical inner surface 532 is configured to fit around a non-cylindrical portion 522 of the axially extending shaft portion 510 of the input disk 500. Thus, in this implementation, the non-cylindrical inner surface 532 has a hexagonal shape, although other shapes are conceivable. The end surface 534 includes a crimp slot 536. In this implementation, the crimp slot 536 is formed to receive the crimped end of one of the pull wires 416. The crimp slot 536 extends axially inward from the end surface 534 and intersects the cylindrical outer surface 530 at a slot opening 538. In this implementation, the crimp slot 536 includes a bulbous portion and a narrow portion. The bulbous portion may be configured to receive the bulbous end of the pull wire 416, including the crimp attachment portion, and the narrower portion of the pull wire extends from the slot opening 538. In Figure 13, the cylindrical outer surface 530 includes a circumferential groove 540. In this implementation, the circumferential groove 540 extends entirely around the outer cylindrical outer surface 530. A portion of the slot opening 538 intersects with the circumferential groove 540, and the pull wire 416 may extend from the slot opening 538 and be wound around the capstan 504 within the circumferential groove 540. In this implementation, the circumferential groove 540 is asymmetrical; that is, one portion of the circumferential groove 540 is wider than another portion of the radial groove. In this way, the circumferential groove 540 may be configured to accommodate more than one wrap of the pull wire around the capstan 504. In the illustrated implementation, the circumferential groove 540 has a relatively larger width at the slot opening 538 and a relatively smaller width at a location adjacent to but behind the slot opening 538. In some implementations, the circumferential groove 540 may be a helical groove so that additional wire windings do not overlap each other. Such overlap can create localized high stress on the pull wire and, in some cases, may cause the pull wire to fail.

[0091] In this implementation, as described with reference to Figure 9, the capstan 504 fits into a pocket 476 formed as part of the chassis 404. The pocket 476 includes a slit 477 that allows the pull wire 416 to exit the pocket 476 toward the pulley groove 489 in only one direction, while the pocket 476 holds the pull wire 416 in all other directions. Thus, even when the backend mechanism 304 is detached from the instrument carriage 306 and therefore there is no torque on the capstan, the pull wire 416 remains in the slit 477 of the chassis 404. In some implementations, the pocket 476 includes an inner wall 476a (Figure 9) extending around the capstan 504. The inner wall 476a may have a diameter slightly larger than the diameter of the capstan 504. In some implementations, a gap may be formed between the inner wall 476a of the pocket 476 and the outer circumference 530 of the capstan 504. Depending on the implementation, this gap may be twice or less than twice the diameter of the pull wire, preferably less than the diameter of the pull wire. For example, in an implementation using a pull wire with a diameter of 0.007 inches, the gap between the inner wall 476a of the pocket 476 and the outer circumference of the capstan 504 may be in the range of about 0.007 inches to about 0.005 inches or less. This gap may prevent the pull wire from coming out of the groove 540 of the capstan 504, even when the pull wire is slack. Thus, the pocket 476 may help to hold the pull wire on the capstan 504. In the illustrated implementation, the pocket 476 is formed monolithically as part of the chassis 404. In particular, it is desirable that the gap be no more than twice the diameter of the pull wire. A preferred implementation has a gap that is no more than the diameter of the pull wire. Another preferred implementation has a gap that is no more than about twice the diameter of the pull wire.

[0092] Figure 17 shows an implementation in which the capstan 504 is fitted into a pocket 490 formed as a separate component from the chassis 404. Here, the pocket 490 is referred to as a floating pocket because it is not attached to the chassis 404. In the illustrated example, the pocket 490 may include a round body 491 formed as a circumferential wall, at least one wing 492 extending outward from the body 491, and a slit 494 in the body 491. Here, the body 491 includes a relatively cylindrical inner surface (unmarked) that fits around the periphery of the capstan 504. In some examples, the floating pocket 490 may be in contact with the outer diameter or periphery 530 of the capstan 504. Figure 17 shows two wings 492 extending radially outward from the body 491. These protruding wings 492 may act as mechanical stops in cooperation with chassis components or other components to prevent rotation of the pocket 490 together with the capstan 504. In this implementation, the chassis 404 includes two protruding stops 495, each of which is positioned to mechanically interfere with one of the wings 492 to restrict rotation of the pocket 490 in one direction. Working together, the protruding stops 495 and wings 492 restrict or prevent rotation so that the slit 494 remains substantially aligned with the slit 478a of the alignment projection 478 which cooperates with the wheel 486 of the pulley 484. The slit 478a may also be called the pull wire exit gap. In the illustrated implementation, the slit 494 extends along the axial length of the pocket 490. Thus, the slit 494 may allow the pocket 490 to flex, thereby elastically changing its inner diameter. Some implementations of the floating pocket 490 may be sized to have relatively low friction, or may be elastically formed, allowing the capstan 504 to rotate within the floating pocket 490. In this way, the slit 494 may still align with the wheel 486, even if the capstan 504 rotates within the pocket 490.

[0093] In some implementations, the pocket 490 is naturally sized to have an inner diameter slightly smaller than the diameter of the capstan, such that the inner wall of the pocket 490 contacts the outer circumference 530 of the capstan 504. Due to the elastic nature of the pocket 490, the capstan may rotate relative to the pocket 490. However, a tight fit may prevent the pull wire from coming out of the capstan 504, even when there is slack in the pull wire. Thus, the pocket 490 may assist in holding the pull wire in the groove 540 in the capstan 504. In some implementations, the pocket 490 is configured to maintain a light spring contact around substantially the entire circumference of the capstan in order to hold the pull wire in the groove 540 in the capstan 504.

[0094] In the illustrated example, the body 491 of the pocket 490 is molded as a rolled strip whose ends form a slit 494. The shape of the body 491 may also be molded from a compliant, low-friction plastic material that favorably reduces the contact force, coefficient of friction, and resulting friction drag torque on the capstan 504. The overlap of one end on the other end forms a "6" shape, with the curved portion 491a forming a substantially cylindrical body 491 and the linear portion 491b extending from the tangent of the circle at the slit 494. However, other shapes are conceivable. For example, in another embodiment, the body 491 may be in contact with the capstan 504 at spaced intervals along the periphery of the capstan 504.

[0095] Figure 9 shows the chassis 404 with the capstan 504 in place relative to the pulley 484. The spindle 488 of the pulley 484 defines a rotation axis 800 that is perpendicular to the rotation axis 802 of the capstan 504. In this embodiment, the rotation axis of the capstan 504 is also substantially parallel to the longitudinal axis of the elongated member 202. Thus, the rotation axis of the pulley 484 is substantially perpendicular to the longitudinal axis of the elongated member.

[0096] Figure 14 shows additional details of the support fixture 410. In this embodiment, the support fixture 410 is configured to adhere to the chassis 404 to secure the steering component 406 and the drive component 408 in place. In the specific embodiments shown, alignment elements 580 (Figure 9), indicated as projecting nubs or posts, are positioned on the chassis 404 to cooperate with alignment elements 582 (Figure 14), indicated as notches or nub-receiving apertures on the support fixture 410. In some implementations, the elongated posts 580a of the alignment element 580 in Figure 9 engage with the illustrated elongated holes 582a of the alignment element 582 in Figure 14 to precisely align the support fixture 410 with the chassis 404. The circular knot of the alignment element 580 in Figure 9 engages with the circular hole of the alignment element in Figure 14 and is heat-staked into the countersink of the circular hole in Figure 14, fastening the support mount 410 to the chassis 404. If the support mount 410 is in place, the spindle 488 of the pulley 484 is secured within the trough 475 of the support projection 472. Similarly, the drive component 408 may be secured to the support mount 410 in appropriate place.

[0097] In the illustrated implementation, the support fixture 410 also includes a coil pipe mount 584 configured to hold the coil pipe 417 and align the pull wire 416 with a groove 489 in the pulley 484, so that the pull wire 416 is positioned at a height corresponding to the bottom of the groove in the pulley 484. The coil pipe mount 584 may be monolithically formed within the support fixture 410, and in this implementation, includes a trough 586 sized and configured to receive a tubular pipe element 588 configured to interface with the coil pipe 417 extending to the distal end of the elongated member 310. For ease of explanation, only one tubular pipe element 588 is shown in Figure 14. The tubular pipe element 588 includes an inner passage, inside which the coil pipe 417 is coupled, while the pull wire 416 extends through both grooves 489 in the wheel 486 of the pulley 484. The coil pipe 417 is secured by the coil pipe mount 584, which prevents the coil pipe from moving proximal to the pulley 484.

[0098] Returning to Figure 5, the fiber connector 412 protrudes from the mounting surface 460 of the chassis 404. A matching receiving connector (not shown) is positioned on the fixture carriage 306. The fiber connector 412 communicates information from the shape sensor 314 to the fixture carriage 306, and ultimately to the control system 112.

[0099] The launch area mount 414 is shown in Figures 5, 8, and 14. The launch area mount 414 consists of a series of stabilizing components configured to rigidly support the proximal end of the shape sensor 314. In this embodiment, the launch area mount 414 includes two clamps 590 and 592 that are attached to a portion of the support mount 410 and pinch the shape sensor 314 to prevent movement or misalignment. In this implementation, the two clamps 590 and 592 are spaced apart from each other along an axis substantially parallel to the axis of the elongated member as the elongated member exits the housing 400. Although described as being secured via clamps, in other implementations, the launch area mount 414 may be attached to the shape sensor 314 via adhesive or other attachment mechanism. From the launch area mount 414, the shape sensor 314 rotates 180° and enters the elongated member 310, as shown in Figure 4.

[0100] Referring to general operation, it is worth noting that in an implementation utilizing four pull wires 416 spaced 90° apart along the circumference of an elongated member, each pull wire is fixed to and extends from the distal end of the elongated member 310. In alternative embodiments, any number of pull wires may be used, spaced at varying distances along the circumference of the elongated member, depending on the desired steering configuration, with each pull wire extending from the distal end of the elongated member 310. While a single pull wire implementation is described herein, it should be noted that this implementation may apply to each of the pull wires acting on the elongated member 310. The proximal end of the pull wire may be wound around a capstan as described herein. Pull wires providing articulated action on the same axis, such as yaw or pitch, may be wound around capstans positioned diagonally to each other within the backend mechanism 304. In some implementations, each pull wire 416 runs through a coil pipe 417 connected to the distal section of the elongated member 310. Each coil pipe 417 is paired with a pull wire 416 to extend the length of the elongated member to the distal portion of the elongated member and exit the elongated member at the proximal portion. Examples of pull wires and coil pipes in an elongated member can be found in Patent Document 9, filed July 21, 2017, entitled "Flexible Elongate Devices Systems and Methods," which is incorporated herein by reference. In some implementations, the coil pipe and the pull wire contained therein exit the elongated member 310 of the backend mechanism 304. In some implementations, each coil pipe and the pull wire contained therein proceed from the elongated member 310 to a support fixture 410 and bend at 90°. In this case, the coil pipe 417 may terminate at an end that is fixed to the support fixture 410 with a coil pipe mount 584 that accommodates a tubular pipe element 588.The coil pipe 417 proceeds through the tubular pipe element 588 and terminates, being joined inside the tubular pipe element 588, while the pull wire 416 passes through and over the tubular pipe element 588, routes around the wheel 486 of the pulley 484, then wraps around the capstan 504, and is finally secured within the crimp slot 536 of the capstan 504. The bending of the coil pipe from the elongated member to the tubular pipe element 588 also provides some slack for pistoning or axial displacement that may be induced by bending or maneuvering the elongated member.

[0101] As described herein, the capstan 504 is oriented perpendicular to the pulley 484. This and routing the pull wire 180 degrees around the pulley may allow for larger radius bends in the pull wire while still providing a compact-sized backend mechanism 304. In addition, the slit 477 in the wall of the pocket 476, in combination with the alignment projection 478 cooperating with the wheel 486 of the pulley 484, provides support for the pull wire and reduces the risk of the pull wire becoming loose and displaced, causing it to deviate from its track. Furthermore, the alignment of the coil pipe and the tubular pipe element 588 may feed the pulley wire into the pulley along a tangent to the pulley groove pitch circle. Thus, the coil pipe helps to align the pull wire within the pulley groove. In some implementations, the coil pipes may be bonded to the tubular pipe element 588, for example, using adhesive, to fix them in place. Other bonding methods may also be used.

[0102] Depending on the implementation, in some implementations, the shape sensor, which is an optical fiber, may be integrated within the elongated member by traveling through a fiber lumen within the elongated member from the distal end to the proximal end of the elongated member and terminating within a back-end mechanism 304. In some implementations, the fiber exits the elongated member, bends 180°, passes through a firing area fixture, and terminates within a fiber connector. The firing area fixture holds the shape sensor in a known linear configuration used as the origin and for calibration during shape sensing. In some implementations, the shape sensor is embedded in a hypotube made of a concentric, heavy-walled, small-inner-diameter metal tube. In some implementations, the hypotube is selected to be a 0.0143 ID × 0.020 wall, 304 stainless steel hypotube, and Shore A40 durometer silicone rubber adhesive / sealant is used to bond the fiber within the hypotube. In some implementations, the proximal end of the shape sensor is bonded to the hypotube with adhesive or glue. The shape sensor 314 may obtain shape sensing data from the firing area mounting fixture to the distal end of the elongated member. Furthermore, the service loop 434 may adapt to instances in which the shape sensor 314 is displaced axially in the longitudinal direction within the elongated member. The service loop 434 may adapt to such displacement or piston action in cases where the shape sensor 314 is fixed to the distal portion of the elongated member and floats within a lumen contained in a flexible body of the elongated member, such as the flexible body 216 of the elongated member 202.

[0103] In the illustrated implementation, referring to Figure 3A, the backend mechanism 304 is mounted to the fixture carriage 306 in an orthogonal direction. That is, the actuating motors within the fixture carriage 306 are positioned such that their rotation axes are parallel to the insertion axis of the elongated member 310. Referring to Figure 10, as described herein, the mounting surface 460 of the chassis 404 includes the surface 514 of the input disk 500, so that the elongated member opening 464 and the drive component opening 466 both have parallel axes; that is, each has an axis extending from the mounting surface 460 of the chassis 404. In this implementation, the fiber connector 412 also extends from the mounting surface 460 in the direction of the elongated member 310. In some embodiments, referring to Figure 10, only a portion of the mounting surface 460 interfaces with the fixture carriage 306 and the implementation. For example, in some implementations, the mounting surface 460 includes an interface portion 526 and a non-interface portion 528. The interface portion 526 may include the input disk 500 and the fiber connector 412. The interface portion 526 may abut the fixture carriage 306 in Figure 3A. The non-interface portion 528 may be parallel to the interface portion 526. In this implementation, the non-interface portion 528 includes an elongated member opening 464 from which an elongated member extends. Thus, the elongated member 310 may be positioned to protrude from the non-interface portion of the mounting surface 460 beyond the side of the fixture carriage 306, so that the elongated member 310 may extend through the elongated member opening 464 without passing through the fixture carriage 306 and without interference from the fixture carriage 306, even while the surface 514 of the fiber connector 412 and the input disk 500 are engaged and interfaced with the fixture carriage 306. Some implementations also include a printed circuit assembly 806 that may communicate with the fixture carriage 306.

[0104] Still referring to Figure 10, the interface portion 526 may include a plurality of mounts 560 configured to engage with the instrument carriage 306. In some implementations, the interface portion 526 includes three mounts 560 molded and configured to provide a kinematic mount that provides stability and repeatability in positioning and orientation of the backend mechanism in a particular orientation. Using a kinematic mount can improve the reliability and accuracy of measurements, even when the backend mechanism is disengaged and reengaged. In the illustrated embodiment, the mounts 560 on the mounting surface 460 are formed by V-shaped grooves or slots, each accommodating a corresponding ball or hemispherical head on the instrument carriage 306. The three balls (or hemispherical heads) and V-shaped grooves cooperate for repeatable and stable mounting of the backend mechanism. In the illustrated implementation, each of the mounts 560 includes two intersecting, orthogonally oriented V-shaped grooves that together form a recess or pocket for accommodating the balls (or hemispherical heads). In the illustrated exemplary embodiment, one of the V-shaped grooves of each mount 560 is wider than or angled differently from the corresponding V-shaped grooves. A wider V-shaped groove may allow a ball or hemispherical head to easily enter the recess or pocket formed by the V-shaped groove. A narrower V-shaped groove may guide the ball or hemispherical head to a precise position relative to the instrument carriage 306. Thus, the kinematic mount provides repeatable and precise positioning of the backend mechanism relative to the instrument carriage 306. For reference, Figure 10 includes three reference axes 780a, 780b, and 780c, each reference axis aligned with the narrower V-shaped groove of the three mounts 560. As can be seen, the reference axes 780a, 780b, and 780c each extend in different directions, thereby providing stability to the kinematic mount, while each of the intersecting orthogonal V-shaped grooves allows for easy alignment, guiding the ball or hemispherical head into the narrower, more stabilizing V-shaped groove. The misalignment of the three reference axes 780a, 780b, and 780c prevents undesirable displacement in the six degrees of freedom.

[0105] Figures 15 and 16 show other implementations and diagrams of the instrument carriage 700 and the back-end mechanism 750. The principles and teachings of the instrument carriage 700 and the back-end mechanism 750 may be implemented and included in the instrument carriage 306 and the back-end mechanism 304.

[0106] The instrument carriage 700 in Figure 15 includes a number of pogo pins 702 that may communicate with a printed circuit assembly on the backend mechanism 750. The instrument carriage 700 includes an output disk 704, a female fiber connector 706, a kinematic mounting component 708, and a latch lever 710. The output disk 704 is driven by a motor supported on the instrument carriage 700 and may engage with an input disk on the backend mechanism. The female fiber connector 706 may accept a protruding fiber connector on the backend mechanism, and the kinematic mounting component 708 may be shaped and configured to engage with a corresponding kinematic mounting component on the backend mechanism. In this implementation, the kinematic mounting component 708 is a ball or hemisphere fixedly positioned to engage with a V-groove slot on the backend mechanism. The latch lever 710 may protrude from a corresponding side of the instrument carriage 700 and may be configured to engage and secure the backend mechanism to the instrument carriage.

[0107] The backend mechanism 750 in Figure 16 has a mounting surface 751 that includes a printed circuit assembly 752, an input disk 754, a mount 756, a carriage latch connector 758, and a fiber connector 759. The printed circuit assembly 752 may communicate with pogo pins 702 on the instrument carriage 700. The input disk 754 may engage with and be driven by the output disk 704. The mount 756 may be a V-shaped groove positioned on the instrument carriage 700 to receive a kinematic mount component 708. The carriage latch connector 758 is shown as a slot for receiving a latch lever 710. In this embodiment, the carriage latch connector 758 is located on both sides of the backend mechanism 750. In addition, the latch lever 710 may include a connector such as an arrowhead-shaped element, and the carriage latch connector 758 may include a shoulder configured to engage with the arrowhead-shaped element in such a way that the backend mechanism 750 is snapped into place on the instrument carriage 700. Other connectors are conceivable. In some implementations, the latch connector is located outside the sealed area to prevent fluid ingress. In some embodiments, the connector includes a shield or seal to prevent fluid ingress. In some implementations, the connection may be performed by the user with one hand. As can be seen, the mounting surface of the backend mechanism 750 includes an elongated member opening 760, and the elongated member 762 extends through the elongated member opening 760. As described and illustrated in other implementations herein, the mounting surface 751 has an interface portion and a non-interface portion, with the elongated member opening 760 and a non-interface portion. In other words, when the pogo pins of the fixture carriage 700 are aligned with the circuit assembly 752 of the backend mechanism 750, the non-interfacing portion of the mounting surface 751 protrudes upward beyond the side of the fixture carriage 700. Therefore, the elongated member opening 760 is located in a place where it does not interface with the fixture carriage 700.It is worth noting that some mountings have components arranged in reverse order, such as the mounting surface 751 containing pogo pins 702 and the fixture carriage containing a printed circuit assembly 752.

[0108] In some implementations, the backend mechanism 750 may be mounted to the instrument carriage 700 using a stepwise engagement and alignment process. This may allow for precise, low-force, one-handed mounting of the backend mechanism onto the instrument carriage 700. In doing so, the input disk may engage with the output disk. In some implementations, the engagement sequence is determined by the height or length of the mating configurations, progressing sequentially from mating configurations with fewer constraints and repeatability to those with more constraints and repeatability. In the engagement sequence, this includes the mating of the elongated member 762, the subsequent mating of the optical fiber connector, and the mating of the carriage latch lever into a slot in the backend mechanism 750. This is followed by the ball mount into a kinematic mount sheet in a V-shaped groove. For ease of understanding, reference axes 780a, 780b, and 780c, illustrated and described with reference to Figure 10, are also identified in Figure 16 as being aligned with the direction of the kinematic mount 756. In some implementations, mount 756 in Figure 16 may perform the function of mount 560 as described with reference to Figure 10. In this case, the pogo pins make contact with the printed circuit assembly contact pads. In the final step, the output disk may rotate to engage with the slot of the input disk. Finally, the printed circuit assembly in the backend mechanism 750 may communicate fiber calibration information, serial number, tool type information, usage count information, and encrypted data to prevent counterfeiting.

[0109] In some implementations, the backend mechanism 304 is coupled to the instrument carriage 306, so that the instrument carriage can be advanced toward or away from the patient P (see Figures 3A and 3B). Figure 18 shows a flowchart of an exemplary method 1800 for coupling the backend mechanism 304 to an insertion assembly such as the instrument carriage 306. It begins at 1802 and includes introducing an elongated member 310 to the patient. As described herein, the elongated device may include a shape sensor 314. At this stage, only the distal portion of the elongated device may be introduced to the patient.

[0110] In 1804, the backend mechanism may engage with the instrument carriage 306 by advancing the instrument carriage in the direction of the elongated device until the fiber connector engages with the corresponding connector on the instrument carriage. In some implementations, the fiber connector may be snapped into place.

[0111] In 1806, a latch interface 496 (Figures 4 and 10), positioned on the mounting surface and protruding from the back-end mechanism toward the instrument carriage, may be introduced into a receptacle on the instrument carriage. Embodiments including a latch lever 710 may also initiate engagement.

[0112] In 1808, mount 756 receives the kinematic mount component 708. Embodiments of the mount having a V-shaped groove may allow for consistent and repeatable positioning. In some implementations, the kinematic mount component 708 is molded as a hemispherical ball, and the mount may guide the hemispherical ball of the kinematic mount component to precise location in order to achieve sufficient constraint of the backend mechanism in all six degrees of freedom in the manner described herein.

[0113] It should be noted that specific interface configurations of the instrument carriage and the backend mechanism may be switched from one to the other without departing from the principles described herein. For example, the instrument carriage may include a kinematic mount component, and the backend mechanism may include a mount.

[0114] In some implementations, the latch mechanism provides high rigidity to withstand user forces and drive reaction forces applied to the biopsy needle handle, while enabling one-handed mounting of the backend mechanism relative to the motor output of the insertion axis carriage.

[0115] In some implementations, the latch connector on the carriage may be spring-loaded and compressed by opposing sides to release the backend mechanism from the instrument carriage. In some implementations, clamps to the housing and the cover enclosing the input may prevent fluid ingress during fully submersible cleaning and high-level disinfection processes.

[0116] Any reference to surgical instruments and surgical methods described herein is not limited, as the instruments and methods described herein may be used with animals, human corpses, animal corpses, parts of human or animal anatomical structures, non-surgical diagnostics, industrial systems, and general robotic or remotely operated systems.

[0117] While exemplary embodiments have been illustrated and described, a wide range of modifications, alterations, and substitutions are anticipated in the foregoing disclosure, and in some cases, some configurations of the embodiments may be used without corresponding use of other configurations. Those skilled in the art will recognize many variations, substitutions, and modifications. Therefore, the scope of the invention should be limited only by subsequent claims, which should be interpreted broadly in a manner consistent with the scope of the embodiments disclosed herein. [Prior art documents] [Patent Documents]

[0118] [Patent Document 1] U.S. Patent Application No. 13 / 107,562 [Patent Document 2] U.S. Patent Application No. 13 / 180,389 [Patent Document 3] U.S. Patent Application No. 12 / 047,056 [Patent Document 4] U.S. Patent No. 6,389,187 [Patent Document 5] U.S. Patent No. 6,380,732 [Patent Document 6] U.S. Patent No. 7,316,681 [Patent Document 7] U.S. Patent Application No. 12 / 286,644 [Patent Document 8] U.S. Patent Application No. 13 / 274,208 [Patent Document 9] U.S. Provisional Patent Application No. 62 / 535,673

Claims

1. A system for maneuvering long, slender components, A chassis comprising a steering component support surface and an opposing mounting surface, wherein the steering component support surface supports a capstan operably coupled to a pull wire configured to steer the elongated member, An input disk is positioned on the mounting surface and configured to rotate the capstan and displace the pull wire, A fiber connector, which is disposed on the mounting surface and extends away from the steering component support surface, is included. The input disk and the fiber connector are configured to be mounted on the instrument carriage, the fiber connector is configured to communicate sensor information from the optical fiber to the control system via the instrument carriage, and the optical fiber extends through the length of the elongated member. system.

2. The system according to claim 1, further comprising a cover, wherein the cover and the chassis are sealed to each other at an interface to form a sealed area of ​​the housing, and the interface is shielded to prevent the ingress of fluid.

3. The system according to claim 2, wherein the chassis includes a peripheral groove, and the cover has an edge that fits snugly into the peripheral groove.

4. The system according to claim 2, further comprising a connector for attaching the chassis to the instrument carriage.

5. The system according to claim 4, wherein the connector includes a shield to prevent fluid ingress.

6. The system according to claim 4, wherein the connector is positioned outside the area to be sealed in order to prevent the ingress of fluid.

7. The system according to claim 1, wherein the input disk passes through an opening in the chassis, and the input disk has a shielding surface that prevents fluid from entering.

8. The system according to claim 1, wherein the sensor information from the optical fiber includes information regarding the shape of the elongated member.

9. The system according to claim 8, wherein the optical fiber is a shape sensor and is configured to detect the shape of the elongated member.

10. The system according to claim 8, further comprising a emission region mounting fixture configured to support the proximal end of the optical fiber.

11. The system according to claim 10, wherein the launch area mounting device is attached to a support mounting device, and the support mounting device is attached to the chassis.

12. The system according to claim 10, wherein the emission area mounting fixture includes two clamps configured to pinch the optical fiber and secure the optical fiber to the emission area mounting fixture.

13. The system according to claim 10, wherein the emission area mounting fixture is attached to the optical fiber via an adhesive.

14. The system according to claim 10, wherein the optical fiber rotates between 90 and 270 degrees from the emission area mounting fixture and enters the proximal portion of the elongated member to form a service loop.

15. The system according to claim 14, further comprising a guide slot, the guide slot being configured to maintain the optical fiber in the form of the service loop and to allow a variable length of slack in the optical fiber from the emitter mounting fixture to the proximal portion of the elongated member.

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