Flexible elongate device with axial support structure

Abstract

The invention relates to a flexible elongated device with an axial support structure. The flexible elongate device includes an elongate body having an articulatable body portion and an axial support structure within the articulatable body portion. The axial support structure may include a plurality of transverse support segments with tubular struts disposed between the support segments. The flexible elongate device may include a component wire having a helical shape within the articulatable body portion.

Description

Technical Field

[0001] The disclosed embodiments relate to flexible elongated devices. Background Art

[0002] Minimally invasive medical techniques are intended to reduce the amount of tissue damaged during medical procedures, thereby reducing patient recovery time, discomfort, and harmful side effects. Such minimally invasive techniques can be performed through natural orifices in the patient's anatomical structure or through one or more surgical orifices. Through these natural orifices or orifices, doctors can insert minimally invasive medical devices (including surgical, diagnostic, therapeutic, and / or biopsy instruments) to reach the target tissue location point. One such minimally invasive technique is the use of a flexible and / or manipulable elongated device such as a flexible catheter or endoscope, which can be inserted into an anatomical passage and navigated toward an area of ​​interest within the patient's anatomical structure. Summary of the invention

[0003] The following presents a simplified summary of various examples described herein and is not intended to identify key or critical elements or to delineate the scope of the claims.

[0004] According to a first example, a flexible elongated device is provided herein, the device comprising an elongated body having an articulated main body portion and an axial support structure in the articulated main body portion. The axial support structure comprises a transverse support segment and a tubular strut. The transverse support segment is longitudinally spaced apart along the articulated main body portion, wherein each support segment receives a plurality of stay wires for controlling the articulation / articulation of the articulated main body portion. The tubular strut is disposed between adjacent support segments, wherein adjacent tubular struts separated by one of the support segments are offset circumferentially relative to each other. Each tubular strut also receives stay wires passing therethrough.

[0005] According to a second example, a flexible, elongated device is provided herein, comprising an elongated body, the elongated body comprising an articulated body portion, wherein the articulated body portion comprises an axial support structure and an inner body member within the axial support structure. The flexible, elongated device also comprises a component wire within the axial support structure, wherein the component wire extends around the inner body member in a spiral shape. The inner body member has a spiral configuration to accommodate the spiral shape of the component wire within the axial support structure.

[0006] It should be understood that the above general description and the following detailed description are illustrative and explanatory in nature, intended to provide an understanding of the present disclosure, but not to limit the scope of the present disclosure. In this regard, for those skilled in the art, other aspects, features and advantages of the present disclosure will be apparent through the following detailed description. BRIEF DESCRIPTION OF THE DRAWINGS

[0007] Figure 1is a simplified diagram of a medical system according to some embodiments.

[0008] Figure 2A is a simplified diagram of a medical device system according to some embodiments.

[0009] Figure 2B is a simplified illustration of a medical device including a medical tool within an elongated device according to some embodiments.

[0010] Figure 3A and Figure 3B is a simplified illustration of a side view of a patient coordinate space including a medical device mounted on an insertion assembly according to some embodiments.

[0011] Figure 4 is a simplified schematic cross-sectional illustration of a portion of a flexible elongated device according to some embodiments.

[0012] Figure 5 is a simplified schematic diagram of a portion of a flexible elongated device according to some embodiments.

[0013] Figure 6A-6D is a schematic cross-sectional view of a support segment of an exemplary axial support structure having a body member and a component line extending therethrough, showing the body member and the component line in sequential positions, according to some embodiments.

[0014] Figure 7 is a schematic perspective view of a support segment of an exemplary axial support structure according to some embodiments.

[0015] Embodiments of the present disclosure and their advantages can be most clearly understood by referring to the detailed description below. It should be understood that the same reference numerals are used to identify the same elements shown in one or more figures, where the contents shown are for illustrating embodiments of the present disclosure, rather than for limiting embodiments of the present disclosure. DETAILED DESCRIPTION

[0016] In the following description, specific details will be set forth, which describe some embodiments consistent with the present disclosure. In order to provide a comprehensive understanding of the embodiments, many specific details are set forth. However, it is obvious to those skilled in the art that some embodiments may be implemented without some or all of these specific details. The specific embodiments disclosed herein are intended to be illustrative rather than limiting. Those skilled in the art may recognize that other elements, although not specifically described herein, are within the scope and spirit of the present disclosure. In addition, to avoid unnecessary repetition, one or more of the features shown and described associated with an embodiment may be incorporated into other embodiments unless otherwise specifically described or one or more features would render the embodiment nonfunctional. In some cases, well-known methods, procedures, components, and circuits are not described in detail to avoid unnecessarily obscuring various aspects of the embodiments of the present invention.

[0017] The present disclosure describes the apparatus and the parts of the apparatus with the states of the parts of various apparatus and apparatus in three-dimensional space. As used herein, the term "position" refers to the locating point of an object or a part of an object in three-dimensional space (e.g., three translational degrees of freedom along Cartesian x, y and z coordinates). As used herein, the term "orientation" refers to the rotational placement of an object or a part of an object (e.g., one or more rotational degrees of freedom, such as roll, pitch and yaw). As used herein, the term "posture" refers to the position of an object or a part of an object in at least one translational degree of freedom, and the orientation of the object or a part of an object in at least one rotational degree of freedom (e.g., up to six degrees of freedom). As used herein, the term "shape" refers to a set of postures, positions and / or orientations measured along an object. As used herein, the term "distal" refers to a position closer to a procedural site, and the term "proximal" refers to a position further away from a procedural site. Therefore, when the apparatus is designed to perform a procedure, the distal portion or distal end of the apparatus is closer to the procedural site than the proximal portion or proximal end of the apparatus.

[0018] A flexible, elongated device including an articulatable body portion may include an axial support structure for maintaining a neutral axis length of the articulatable body portion during articulation of the articulatable body portion and supporting the articulatable body portion to resist axial loads generated during manipulation of the articulatable body portion. For example, the axial support structure may prevent or reduce deformation, compression, and / or collapse of the articulatable body portion under axial loads.

[0019] Some axial support structures for flexible devices can be formed by cutting material from a tubular structure. Compared with such axial support structures, the material and manufacturing costs of the axial support structures provided herein are lower. The axial support structures also provide a better maintained neutral axis length, a smaller outer diameter and / or a larger working channel, and support helical or sensor integration.

[0020] The axial support structure as provided herein comprises a plurality of support segments separated along the longitudinal axis of the flexible elongated device. The support segments are separated by struts that provide axial stiffness to the axial support structure. Adjacent support segments are separated by at least one pair of struts disposed on opposite sides of the support segments, which allows the axial support structure to bend relative to the struts along an axis transverse to the neutral axis. Adjacent strut pairs are offset circumferentially relative to each other (e.g., 90 degree offset, 120 degree offset, etc.) to allow the axial support structure and therefore the articulated main body portion to bend along multiple axes (e.g., pitch and yaw).

[0021] In some instances, the articulation of the articulated main body portion of the flexible elongated device can be achieved by manipulating a pull wire, which is connected to a control structure (e.g., a control ring) disposed within the articulated main body portion. The control structure to which the pull wire is attached is distal to the axial support structure, and the pull wire passes through the axial support structure to reach the control structure. In these instances, the support segment may include a pull wire opening extending therethrough, and the strut may be tubular so that the pull wire can pass through a plurality of support segments and struts. The support segment and / or the strut may be made of a lubricating material, or include a lubricating coating to allow the pull wire to translate / shift therein without severe friction.

[0022] In some examples, the flexible elongated device may include an inner body member that may define a lumen for the flexible elongated device. In these examples, the support segment may have a hole that is sized to receive the inner body member therethrough. In addition, the flexible elongated device may include one or more component wires (e.g., wires, (e.g., shape) sensors, conductors, etc.) that extend between the outer surface of the inner body member and the hole of the axial support structure within the flexible elongated device. In one embodiment, regardless of the circumferential positioning point, the size of the hole of the support segment can be designed to provide sufficient clearance for the component wire (e.g., the difference in the radius of the hole is greater than or equal to the thickness of the component wire). In another embodiment, the size of the diameter of the hole of the support segment can be designed to provide sufficient clearance for the component wire, wherein the inner body member deviates from the center of the hole. In this configuration, the inner body member may have a spiral configuration so that the gap between the hole of the support segment and the inner body member has an offset that provides space for the component wire, wherein the component wire is wound around the inner body member in a spiral shape. The helical shape of the component wire can provide benefits for the flexible elongated device, including, for example, that the shape sensor provides a volumetric representation of the articulatable body portion and addresses tensile and compressive stresses in the component wire when the component wire is outside of a bend in the articulatable body portion. In one example, the support segment is annular with a circular hole, the inner body member has a circular cross-section, and the component wire passes through a space between an outer surface of the inner body member and the circular hole of the support segment.

[0023] Figure 1is a simplified schematic diagram of a medical system 100 according to some embodiments. The medical system 100 may be applicable, for example, to surgical, diagnostic (e.g., biopsy) or therapeutic (e.g., ablation, electroporation, etc.) procedures. Although some embodiments are provided herein with respect to such procedures, any reference to medical or surgical instruments and medical or surgical methods is not limiting. The systems, instruments, and methods described herein may be used in animals, human cadavers, animal cadavers, portions of human or animal anatomy, non-surgical diagnostics, and in industrial systems, general or special purpose robotic systems, general or special purpose teleoperation systems, or robotic medical systems.

[0024] like Figure 1 As shown, the medical system 100 may include a manipulator assembly 102 that controls the operation of a medical instrument 104 when performing various procedures on a patient P. The medical instrument 104 may extend to an internal part of the patient P body via an opening in the patient P body. The manipulator assembly 102 may be a remotely operated, non-remotely operated, or hybrid remotely operated and non-remotely operated assembly, having one or more degrees of freedom of motion that may be motorized and / or one or more degrees of freedom of motion that may be non-motorized (e.g., manually operated). The manipulator assembly 102 may be mounted to a patient table T and / or positioned near the patient table. A main assembly 106 allows an operator O (e.g., a surgeon, clinician, physician, or other user) to control the manipulator assembly 102. In some instances, the main assembly 106 allows the operator O to view a procedure site or other graphic or information display. In some instances, the manipulator assembly 102 may not be included in the medical system 100, and the instrument 104 may be directly controlled by the operator O. In some instances, the manipulator assembly 102 may be manually controlled by the operator O. Direct operator controls may include various handles and operator interfaces for handheld operation of the instrument 104 .

[0025] The main assembly 106 may be located at a surgeon's console that is near (e.g., in the same room) a patient table T where a patient P is located, such as located to one side of the patient table T. In some examples, the main assembly 106 is remote from the patient table T, such as located in a different room or a different building than the patient table T. The main assembly 106 may include one or more control devices for controlling the manipulator assembly 102. The control devices may include any number of various input devices, such as a joystick, trackball, scroll wheel, directional pad, button, data glove, trigger gun, hand controller, voice recognition device, motion or presence sensor, etc.

[0026] The manipulator assembly 102 supports the medical device 104 and may include a kinematic linkage structure that provides a set structure. The linkage may include one or more non-servo-controlled linkages (e.g., one or more linkages that can be manually positioned and locked in place) and / or one or more servo-controlled linkages (e.g., one or more linkages that can be controlled in response to commands (such as from the control system 112)). The manipulator assembly 102 may include a plurality of actuators (e.g., motors) that drive inputs on the medical device 104 in response to commands such as from the control system 112. The actuator may include a drive system that, when coupled to the medical device 104, moves the medical device 104 in various ways. For example, one or more actuators may advance the medical device 104 into a natural or surgically created anatomical orifice. The actuator may control the articulation of the medical device 104, for example by moving the distal end (or any other portion) of the medical device 104 in multiple degrees of freedom. These degrees of freedom may include three degrees of linear motion (e.g., linear motion along the X, Y, Z Cartesian axes) and three degrees of rotational motion (e.g., rotation about the X, Y, Z Cartesian axes). One or more actuators may control the rotation of the medical device about the longitudinal axis. The actuators may also be used to move an articulated end effector of the medical device 104 to grasp tissue, for example, in the jaws of a biopsy device, or may be used to move or otherwise control a tool inserted into the medical device 104 (e.g., an imaging tool, an ablation tool, a biopsy tool, an electroporation tool, etc.).

[0027] The medical system 100 may include a sensor system 108 having one or more subsystems for receiving information about the manipulator assembly 102 and / or the medical device 104. Such subsystems may include a position sensor system (e.g., the system uses an electromagnetic (EM) sensor or other type of sensor that detects a position or location point); a shape sensor system for determining the position, orientation, speed, velocity, posture, and / or shape of the medical device 104 along the distal end and / or one or more segments of the flexible body; a visualization system (e.g., using a color imaging device, an infrared imaging device, an ultrasound imaging device, an x-ray imaging device, a fluorescence imaging device, a computed tomography (CT) imaging device, a magnetic resonance imaging (MRI) imaging device, or some other type of imaging device) for capturing images, such as from the distal end of the medical device 104 or from some other location point; and / or an actuator position sensor, such as a resolver, an encoder, a potentiometer, etc., which describes the rotation and / or orientation of an actuator that controls the medical device 104.

[0028] The medical system 100 may include a display system 110 for displaying an image or representation of a procedure site and a medical device 104. The display system 110 and the main assembly 106 may be oriented so that the physician O may control the medical device 104 and the main assembly 106 with telepresence.

[0029] In some embodiments, the medical device 104 may include a visualization system, which may include an image capture component that records concurrent or real-time images of the procedure site and provides the images to the operator O through one or more displays of the display system 110. The image capture component may include various types of imaging devices. For example, the concurrent image may be a two-dimensional image or a three-dimensional image captured by an endoscope positioned within the anatomical procedure site. In some instances, the visualization system may include an endoscope component that may be integrally or removably coupled to the medical device 104. In addition or alternatively, a separate endoscope attached to a separate manipulator component may be used with the medical device 104 to image the procedure 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 (such as a computer processor of the control system 112).

[0030] The display system 110 may also display images of the procedure site and the medical device that may be captured by the visualization system. In some examples, the medical system 100 provides telepresence to the operator O. For example, images captured by the imaging device at the distal portion of the medical device 104 may be presented by the display system 110 to provide the operator O with a sense of being at the distal portion of the medical device 104. Input provided by the operator O to the main assembly 106 may cause the distal portion of the medical device 104 to move in a manner that corresponds to the nature of the input (e.g., when the trackball is rolled to the right, the distal tip turns to the right) and causes a corresponding change in the perspective of the image captured by the imaging device at the distal portion of the medical device 104. Thus, when the medical device 104 is moved using the main assembly 106, the telepresence of the operator O remains unchanged. The operator O may manipulate the medical device 104 and the hand controls of the main assembly 106 as if viewing the workspace in substantially real telepresence, thereby simulating the experience of an operator actually manipulating the medical device 104 within the patient's anatomy.

[0031] In some examples, the display system 110 can present a virtual image of the procedure site that is created using image data recorded preoperatively (e.g., before the medical device system 200 performs a procedure) or intraoperatively (e.g., while the medical device system 200 performs a procedure), such as image data created using computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET), fluoroscopy, thermal imaging, ultrasound, optical coherence tomography (OCT), thermal imaging, impedance imaging, laser imaging, nanotube X-ray imaging, etc. The virtual image may include a two-dimensional, three-dimensional, or higher-dimensional (e.g., including time-based or velocity-based information) image. In some examples, one or more models are created based on preoperative or intraoperative image data sets, and the virtual image is generated using the one or more models.

[0032] In some examples, for imaging guided medical procedures, the display system 110 may display a virtual image generated based on the tracked anchor points of the medical device 104. For example, the tracked anchor points of the medical device 104 may be registered (e.g., dynamically referenced) with a model generated using preoperative or intraoperative images, where different portions of the model correspond to different anchor points of the patient's anatomy. As the medical device 104 moves within the patient's anatomy, the registration is used to determine the portion of the model that corresponds to the anchor points and / or viewpoints of the medical device 104, and the virtual image is generated using the determined portion of the model. In this way, a virtual image of the internal procedure site may be presented to the operator O from the viewpoint of the medical device 104 that corresponds to the tracked anchor points of the medical device 104.

[0033] Medical system 100 may also include a control system 112, which may include processing circuitry that implements some or all of the methods or functionality discussed herein. Control system 112 may include at least one memory and at least one processor for controlling the operation of manipulator assembly 102, medical device 104, main assembly 106, sensor system 108, and / or display system 110. Control system 112 may include instructions (e.g., a non-transitory machine-readable medium storing instructions) that, when executed by at least one processor, may configure one or more processors to implement some or all of the methods or functionality discussed herein. Although control system 112 may be described in detail in detail, control system 112 may be described in detail in detail. Figure 1 102, but the control system 112 may include two or more independent data processing circuits, where a portion of the processing is performed on the manipulator assembly 102, and another portion of the processing is performed on the main assembly 106, and so on. In some examples, the control system 112 may include other types of processing circuits, such as an application specific integrated circuit (ASIC) and / or a field programmable gate array (FPGA). The control system 112 may be implemented using hardware, firmware, software, or a combination thereof.

[0034] In some examples, control system 112 can receive feedback, such as force and / or torque feedback, from medical device 104. In response to the feedback, control system 112 can transmit a signal to main assembly 106. In some examples, control system 112 can transmit a signal that instructs one or more actuators of manipulator assembly 102 to move medical device 104. In some examples, control system 112 can transmit information about the feedback to display system 110 for presentation, or perform other types of actions based on the feedback.

[0035] The control system 112 may include a virtual visualization system to provide navigation assistance to the operator O when controlling the medical device 104 during an image-guided medical procedure. Virtual navigation using the virtual visualization system may be based on a preoperative or intraoperative data set of an acquired anatomical pathway of the patient P. The control system 112 or an independent computing device may convert the recorded image into a model of the patient's anatomical structure using programming instructions alone or in combination with operator input. The model may include a segmented two-dimensional or three-dimensional composite presentation of a portion or entire anatomical organ or anatomical region. The image data set may be associated with the composite presentation. The virtual visualization system may acquire sensor data from the sensor system 108, which is used to calculate the (e.g., approximate) positioning point of the medical device 104 relative to the anatomical structure of the patient P. The sensor system 108 may be used to register and display the medical device 104 with the preoperative or intraoperative recorded image. For example, PCT Publication WO2016 / 191298 (published on December 1, 2016, entitled "Systems and Methods of Registration for Image Guided Surgery") discloses an exemplary system, which is incorporated herein by reference in its entirety.

[0036] During a virtual navigation procedure, the sensor system 108 may be used to calculate a (e.g., approximate) location point of the medical device 104 relative to the anatomical structure of the patient P. The location point may be used to generate a macroscopic (e.g., external) tracking image of the anatomical structure of the patient P and a virtual internal image of the anatomical structure of the patient P. The system may include one or more electromagnetic (EM) sensors, fiber optic sensors, and / or other sensors to align and display the medical device with a preoperatively recorded medical image. For example, U.S. Patent No. 8,900,131 (filed on May 13, 2011 and entitled "Medical System Providing Dynamic Registration of a Model of an Anatomic Structure for Image-Guided Surgery") discloses an exemplary system, which is incorporated herein by reference in its entirety.

[0037] The medical system 100 may also include operating and support systems (not shown), such as lighting systems, steering control systems, irrigation systems, and / or suction systems. In some embodiments, the medical system 100 may include more than one manipulator assembly and / or more than one main assembly. The exact number of manipulator assemblies may depend on factors such as medical procedures and space limitations in the procedure room. Multiple main assemblies may be co-located, or they may be located at independent positioning points. Multiple main assemblies may allow more than one operator to control one or more manipulator assemblies in various combinations.

[0038] Figure 2A 2 is a simplified diagram of a medical device system 200 according to some embodiments. The medical device system 200 includes a flexible elongated device 202 (also referred to as the elongated device 202), a drive unit 204, and a medical tool 226, which together constitute an example of a medical device 104 of the medical system 100. Figure 1 As described above, the medical system 100 can be a remote operation system, a non-remote operation system, or a hybrid remote operation and non-remote operation system. The visualization system 231, the tracking system 230, and the navigation system 232 are also Figure 2A , and are exemplary components of the control system 112 of the medical system 100. In some examples, the medical instrument system 200 can be used for non-remotely operated exploratory procedures or procedures involving traditional manually operated medical instruments, such as endoscopy. The medical instrument system 200 can be used to collect (e.g., measure) a set of data points corresponding to a location point within an anatomical passage of a patient (e.g., patient P).

[0039] The elongated device 202 is coupled to the drive unit 204. The elongated device 202 includes a channel 221 through which a medical tool 226 can be inserted. The elongated device 202 travels within the patient's anatomy to deliver the medical tool 226 to the procedure site. The elongated device 202 includes a flexible body 216 having a proximal end 217 and a distal end 218. In some examples, the outer diameter of the flexible body 216 is approximately 3 mm. The outer diameter of other flexible bodies can be larger or smaller.

[0040] As will be described in further detail below, the medical device system 200 may include a tracking system 230 for determining the position, orientation, speed, velocity, posture, and / or shape of the flexible body 216 at the distal end 218 and / or one or more segments 224 along the flexible body 216. The tracking system 230 may include one or more sensors and / or imaging devices. The flexible body 216 (such as the length between the distal end 218 and the proximal end 217) may include a plurality of segments 224. The tracking system 230 may be implemented using hardware, firmware, software, or a combination thereof. In some examples, the tracking system 230 is Figure 1 A portion of control system 112 is shown.

[0041] The tracking system 230 can track the distal end 218 and / or one or more of the segments 224 of the flexible body 216 using a shape sensor 222. The shape sensor 222 can include an optical fiber aligned with the flexible body 216 (e.g., disposed within an internal channel of the flexible body 216 or mounted externally along the flexible body 216). In some examples, the diameter of the optical fiber is approximately 200 μm. In other examples, the diameter can be larger or smaller. The optical fiber of the shape sensor 222 can form a fiber optic bend sensor for determining the shape of the flexible body 216. The optical fiber including a fiber Bragg grating (FBG) can be used to provide strain measurements on a structure in one or more dimensions. Various systems and methods for monitoring the shape and relative position of an optical fiber in three dimensions that may be suitable for use in some embodiments are described in U.S. Patent Application Publication No. 2006 / 0013523 (filed on July 13, 2005, entitled "Fiber optic position and shape sensing device and method relating thereto"), U.S. Patent No. 7,772,541 (filed on March 12, 2008, entitled "Fiber Optic Position and / or Shape Sensing Based on Rayleigh Scatter"); and U.S. Patent No. 8,773,650 (filed on September 2, 2010, entitled "Optical Position and / or Shape Sensing"), all of which are incorporated herein by reference in their entirety. The sensors in some embodiments may employ other suitable strain sensing techniques, such as Rayleigh scattering, Raman scattering, Brillouin scattering, and fluorescence scattering.

[0042] In some examples, other techniques may be used to determine the shape of the flexible body 216. For example, the history of the position and / or posture of the distal end 218 of the flexible body 216 may be used to reconstruct the shape of the flexible body 216 over a period of time (e.g., when the flexible body 216 is advanced or retracted within the patient's anatomy). In some examples, the tracking system 230 may use the position sensor system 220 instead of and / or in addition to track the distal end 218 of the flexible body 216. The position sensor system 220 may be a component of an EM sensor system, wherein the position sensor system 220 includes one or more position sensors. Although the position sensor system 220 is shown as being close to the distal end 218 of the flexible body 216 to track the distal end 218, the number and location points of the position sensors of the position sensor system 220 may vary to track different areas along the flexible body 216. In one example, the position sensor includes a conductive coil that can be subjected to an externally generated electromagnetic field. Each coil of the position sensor system 220 may generate an induced electrical signal having characteristics that depend on the position and orientation of the coil relative to the externally generated electromagnetic field. The position sensor system 220 can measure one or more position coordinates and / or one or more orientation angles associated with one or more portions of the flexible body 216. In some examples, the position sensor system 220 can be configured and positioned to measure six degrees of freedom, such as three position coordinates X, Y, Z and three orientation angles indicating pitch, yaw, and roll of a base point. In some examples, the position sensor system 220 can be configured and positioned to measure five degrees of freedom, such as three position coordinates X, Y, Z and two orientation angles indicating pitch and yaw of a base point. Additional description of position sensor systems that may be suitable for use in some embodiments is provided in U.S. Patent No. 6,380,732 (filed on August 11, 1999, entitled "Six-Degree of Freedom Tracking System Having a Passive Transponder on the Object Being Tracked"), which is incorporated herein by reference in its entirety.

[0043] In some embodiments, tracking system 230 may alternatively and / or additionally rely on a collection of posture, position, and / or orientation data stored for points of elongated device 202 and / or medical tool 226, which is captured during one or more alternating motion cycles (e.g., breathing). This stored data may be used to form shape information about flexible body 216. In some instances, a series of position sensors (not shown) - such as EM sensors, such as those in position sensors 220, or some other type of position sensor - may be positioned along flexible body 216 and used for shape sensing. In some instances, historical data from one or more of these position sensors acquired during a procedure may be used to represent the shape of elongated device 202, particularly where the anatomical pathway is generally static.

[0044] Figure 2B 2 is a simplified diagram of a medical tool 226 within an elongated device 202 according to some embodiments. The flexible body 216 of the elongated device 202 may include a channel 221 sized and shaped to receive the medical tool 226. In some embodiments, the medical tool 226 may be used for procedures such as diagnosis, imaging, surgery, biopsy, ablation, illumination, irrigation, suction, electroporation, etc. The medical tool 226 may be deployed through the channel 221 of the flexible body 216 and operated at a procedural site within an anatomical structure. The medical device 226 may be, for example, an image capture probe, a biopsy tool (e.g., a needle, a grasper, a brush, etc.), an ablation tool (e.g., a laser ablation tool, a radiofrequency (RF) ablation tool, a cryoablation tool, a thermal ablation tool, a heated liquid ablation tool, etc.), an electroporation tool, and / or other surgical, diagnostic, or therapeutic tool. In some instances, the medical tool 226 may include an end effector having a single working member, such as a scalpel, a blunt knife, an optical fiber, an electrode, etc. Other types of end effectors may include, for example, forceps, graspers, scissors, staplers, clamps, etc. Other end effectors may also include electrically activated end effectors, such as electrosurgical electrodes, transducers, sensors, etc.

[0045] The medical tool 226 may be a biopsy tool for removing a sample tissue or cell sample from a target anatomical location. In some instances, the biopsy tool is a flexible needle. The biopsy tool may also include a sheath that surrounds the flexible needle to protect the inner surface of the needle and the channel 221 when the biopsy tool is located in the channel 221. The medical tool 226 may be an image capture probe that includes a distal portion with a stereoscopic or monoscopic camera that may be placed at or near the distal end 218 of the flexible body 216 for capturing images (e.g., static or video images). The captured image may be processed by a visualization system 231 for display, and / or provided to a tracking system 230 to support tracking of one or more segments of the distal end 218 of the flexible body 216 and / or the segments 224 of the flexible body 216. The image capture probe may include a cable for transmitting captured image data that is coupled to an imaging device at the distal end of the image capture probe. In some instances, the image capture probe may include a fiber optic bundle, such as a fiber endoscope, coupled to a more proximal imaging device of the visualization system 231. The image capture probe may be single-spectrum or multi-spectrum, for example, to capture image data of one or more of the visible, near-infrared, infrared, and / or ultraviolet spectra. The image capture probe may also include one or more light emitters that provide illumination to facilitate image capture. In some instances, the image capture probe may use ultrasound, x-ray, fluoroscopy, CT, MRI, or other types of imaging techniques.

[0046] In some examples, an image capture probe is inserted into the flexible body 216 of the elongated device 202 to facilitate visual navigation of the elongated device 202 to the procedure site, and then replaced with another type of medical tool 226 within the flexible body 216 to perform the procedure. In some examples, the image capture probe can be located within the flexible body 216 of the elongated device 202 along with another type of medical tool 226 to facilitate simultaneous image capture and tissue intervention, such as within the same channel 221 or in separate channels. The medical tool 226 can be advanced from the opening of the channel 221 to perform the procedure (or some other function), and then retracted into the channel 221 after the procedure is completed. The medical tool 226 can be removed from the proximal end 217 of the flexible body 216 or another optional instrument port (not shown) along the flexible body 216.

[0047] In some examples, the elongated device 202 may include integrated imaging capabilities rather than utilizing a movable image capture probe. For example, an imaging device (or fiber bundle) and a light emitter may be located at the distal end 218 of the elongated device 202. The flexible body 216 may include one or more dedicated channels that carry one or more cables and / or one or more optical fibers between the distal end 218 and the visualization system 231. Here, the medical device system 200 may perform imaging and tool operations simultaneously.

[0048] In some examples, the medical tool 226 can be controllably articulated. As discussed herein with respect to the flexible elongated device 202, the medical tool 226 can accommodate a cable (also referred to as a pull wire), a linkage mechanism, or other actuation control (not shown) extending between the proximal and distal ends of the medical tool to controllably bend the distal end of the medical tool 226. The medical tool 226 can be coupled to the drive unit 204 and the manipulator assembly 102. In these examples, the elongated device 202 may not be included in the medical device system 200, or may be a flexible device without controllable articulation. Steerable instruments or tools suitable for some embodiments are described in further detail in the following patents: U.S. Patent No. 7,316,681 (filed on October 4, 2005, entitled "Articulated Surgical Instrument for Performing Minimally Invasive Surgery with Enhanced Dexterity and Sensitivity") and U.S. Patent No. 9,259,274 (filed on September 30, 2008, entitled "Passive Preload and Capstan Drive for Surgical Instruments"), both of which are incorporated herein by reference in their entirety.

[0049] For example, by Figure 2AAs shown in the broken dashed line depiction symbol 219 of the distal end 218, the flexible body 216 of the elongated device 202 may also additionally or alternatively accommodate a cable, a linkage mechanism or other steering control member (not shown) that extends between the drive unit 204 and the distal end 218 to controllably bend the distal end 218. In some examples, at least four cables are used to provide independent up and down steering to control the pitch of the distal end 218, and independent left and right steering to control the deflection of the distal end 281. In these examples, the flexible elongated device 202 may be a steerable catheter. Examples of steerable catheters suitable for some embodiments are described in detail in PCT Publication WO2019 / 018736 (published on January 24, 2019, entitled "Flexible Elongate Device Systems and Methods"), which is incorporated herein by reference in its entirety.

[0050] In embodiments where the elongated device 202 and / or the medical tool 226 are actuated by a remotely operated assembly (e.g., the manipulator assembly 102), the drive unit 204 may include a drive input that is removably coupled to and receives power from a drive element of the remotely operated assembly, such as an actuator. In some examples, the elongated device 202 and / or the medical tool 226 may include a gripping feature, a manual actuator, or other components for manually controlling the movement of the elongated device 202 and / or the medical tool 226. The elongated device 202 may be steerable, or, alternatively, the elongated device 202 may be non-steerable without an integrated mechanism for operator-controlled bending of the distal end 218. In some examples, one or more channels 221 (also referred to as lumens) through which the medical tool 226 may be deployed and used at a target anatomical location may be defined by an inner wall of the flexible body 216 of the elongated device 202.

[0051] In some examples, the medical device system 200 (e.g., the elongated device 202 or the medical tool 226) can include a flexible bronchial instrument, such as a bronchoscope or a bronchial catheter, for inspection, diagnosis, biopsy, and / or treatment of the lungs. The medical device system 200 can also be adapted to access and treat other tissues via natural or surgically created connections in any of a variety of anatomical systems, including the colon, intestines, kidneys and calyces, brain, heart, circulatory system including vasculature, and the like.

[0052] Information from the tracking system 230 may be sent to the navigation system 232, where the information may be combined with information from the visualization system 231 and / or preoperatively acquired models to provide real-time position information to a physician, clinician, surgeon, or other operator. In some instances, the real-time position information may be displayed on the display system 110 for use in controlling the medical device system 200. In some instances, the navigation system 232 may use the position information as feedback for positioning the medical device system 200. Various systems for registering and displaying surgical instruments with surgical images using fiber optic sensors suitable for some embodiments are provided in U.S. Patent No. 8,900,131 (filed May 13, 2011, entitled “Medical System Providing Dynamic Registration of a Model of an Anatomic Structure for Image-Guided Surgery”), which is incorporated herein by reference in its entirety.

[0053] Figure 3A and Figure 3B is a simplified diagram of a side view of a patient coordinate space including a medical device mounted on an insertion assembly according to some embodiments. Figure 3A and Figure 3B As shown, the surgical environment 300 may include a patient P positioned on a patient table T. The patient P may be stationary in the surgical environment 300, with the patient's overall movement limited by sedation, restraints, and / or other means. The periodic anatomical movements of the patient P (including breathing and cardiac movements) may continue. Within the surgical environment 300, a medical device 304 is used to perform a medical procedure, which may include, for example, surgery, biopsy, ablation, illumination, irrigation, suction, or electroporation. The medical device 304 may also be used to perform other types of procedures, such as the following registration procedures: associating the position, orientation, and / or posture data captured by the sensor system 108 with a desired (e.g., anatomical or system) reference system. The medical device 304 may be, for example, the medical device 104. In some instances, the medical device 304 may include an elongated device 310 (e.g., a catheter) coupled to an instrument body 312. The elongated device 310 includes one or more channels sized and shaped to receive a medical tool.

[0054] The elongated device 310 may also include one or more sensors (e.g., components of the sensor system 108). In some examples, a shape sensor 314 may be fixed to the instrument body 312 at a proximal point 316. The proximal point 316 of the shape sensor 314 may move with the instrument body 312, and the location of the proximal point 316 relative to a desired reference frame may be known (e.g., via a tracking sensor or other tracking device). The shape sensor 314 may measure the shape from the proximal point 316 to another point (such as a distal end 318 of the elongated device 310). The shape sensor 314 may be aligned with the elongated device 310 (e.g., disposed within an internal channel or mounted externally). In some examples, the shape sensor 314 may be an optical fiber that is used to generate shape information of the elongated device 310.

[0055] In some examples, position sensors (e.g., EM sensors) can be incorporated into medical device 304. A series of position sensors can be positioned along flexible elongated device 310 and used for shape sensing. Position sensors can be used instead of shape sensor 314 or in addition to shape sensor 314, for example to improve the accuracy of shape sensing or to verify shape information.

[0056] The elongated device 310 may house cables, linkages, or other steering controls that extend between the instrument body 312 and the distal end 318 to controllably bend the distal end 318. In some examples, at least four cables are used to provide independent up and down steering to control the pitch of the distal end 318, and independent left and right steering to control the yaw of the distal end 318. The instrument body 312 may include a drive input that is removably coupled to and receives power from a drive element, such as an actuator, of a manipulator assembly.

[0057] The instrument body 312 can be coupled to an instrument holder 306. The instrument holder 306 can be mounted to an insertion table 308 that is fixed within the surgical environment 300. Alternatively, the insertion table 308 can be movable but have a known location point within the surgical environment 300 (e.g., via a tracking sensor or other tracking device). The instrument holder 306 can be a component of a manipulator assembly (e.g., manipulator assembly 102) that is coupled to the medical device 304 to control insertion movement (e.g., movement along the insertion axis A) and / or movement in multiple directions, such as yaw, pitch, and / or roll, of the distal end 318 of the elongated device 310. The instrument holder 306 or the insertion table 308 can include an actuator, such as a servo motor, that controls the movement of the instrument holder 306 along the insertion table 308.

[0058] The sensor device 320 can be a component of the sensor system 108 that can provide information about the position of the instrument body 312 as it moves along the insertion axis A relative to the insertion stage 308. The sensor device 320 can include one or more resolvers, encoders, potentiometers, and / or other sensors that measure the rotation and / or orientation of an actuator that controls the movement of the instrument holder 306, thereby indicating the movement of the instrument body 312. In some embodiments, as shown in FIG. Figure 3A and Figure 3B As shown, the insertion station 308 has a linear track. In some embodiments, the insertion station 308 may have a curved track or a combination of curved track sections and straight track sections.

[0059] Figure 3A The instrument body 312 and instrument holder 306 are shown in a retracted position along the insertion station 308. In this retracted position, the proximal point 316 is at position L0 on the insertion axis A. The positioning point of the proximal point 316 can be set to a zero value and / or other reference value to provide a benchmark reference (e.g., corresponding to the origin of a desired reference system) for describing the position of the instrument holder 306 along the insertion station 308. In the retracted position, the distal end 318 of the slender device 310 can be located just inside the access channel of the patient P. Also in the retracted position, the data captured by the sensor device 320 can be set to a zero value and / or other reference value (e.g., I=0). Figure 3B , the instrument body 312 and the instrument holder 306 have been advanced along the linear track of the insertion table 308, and the distal end 318 of the slender device 310 has been advanced into the patient P. In this advanced position, the proximal point 316 is at a position L1 on the insertion axis A. In some instances, the rotation and / or orientation of the actuator is measured by a sensor device 320 that indicates the movement of the instrument holder 306 along the insertion table 308 and / or one or more position sensors associated with the instrument holder 306 and / or the insertion table 308, which can be used to determine the position L1 of the proximal point 316 relative to the position L0. In some instances, the position L1 can also be used as an indicator of the distance or insertion depth to which the distal end 318 of the slender device 310 is inserted into one or more passages of the anatomical structure of the patient P.

[0060] Figure 4 and Figure 5 is a simplified diagram of a flexible elongated device 400 according to some embodiments. Figure 1 In some embodiments consistent with FIG. 3 , flexible elongated device 400 may correspond to elongated device 202 of medical device system 200 .

[0061] like Figure 4As shown in a simplified cross-sectional view of FIG. 4 , the flexible elongated device 400 may include a flexible body 402 extending from a proximal section 404 to a distal section 406. It should be understood that the flexible body 402 (including its proximal section 404 and distal section 406) may have any desired length. The flexible elongated device 400 includes an articulated body portion 408, which in some examples may be located in or form the distal section 406 of the flexible elongated device 400.

[0062] In order to control the articulation of the articulated body portion 408, a plurality of pull wires 410 extend along the flexible body 402 and are connected to a control structure 412 (e.g., a control ring) at their distal ends. The pull wires 410 can be connected to the control structure 412 by any suitable method. For example, the pull wires 410 can be connected to the control structure 412 by welding to the exterior of the control structure 412 and / or by extending within a hole in the control structure 412. The pull wires 410 are spaced circumferentially around the flexible body 402. In some embodiments, the pull wires 410 are radially spaced at uniform spacing, while in other embodiments, the pull wires 410 are radially spaced at uneven spacing.

[0063] As shown, the flexible elongated device 400 also includes an axial support structure 414 that receives the pull wire 410 and is configured to bend in response to an actuation force applied to the pull wire 410. To manipulate the flexible elongated device 400, unequal actuation forces are applied to the pull wire 410 so that the articulatable body portion 408 bends in a direction defined by a net torque proportional to the bending stiffness of the distal segment 406 / articulatable body portion 408. The axial support structure 414 supports the articulatable body portion 408 to resist the axial load generated by the actuation force applied to the pull wire 410. Specifically, the axial support structure 414 can prevent or reduce deformation, compression, and / or collapse of the articulatable body portion 408 under the axial load.

[0064] The axial support structure 414 includes support segments 416 and tubular struts 418. As shown, the support segments 416 extend transversely relative to the longitudinal axis L of the flexible elongated device 400 and are spaced longitudinally along the hingeable body portion 408. To provide a sufficient length of the hingeable body portion 408, the axial support structure 414 may include any desired number of support segments 416. The tubular struts 418 extend generally parallel to the longitudinal axis L of the flexible elongated device and are disposed between adjacent support segments 416.

[0065] To allow the axial support structure 414 to bend, longitudinally adjacent tubular struts 418 (e.g., tubular struts 418 with support segments 416 disposed therebetween) are offset circumferentially relative to each other. This configuration provides the axial support structure 414 with axial stiffness while allowing adjacent portions of the axial support structure to bend in different directions (e.g., along a transverse axis relative to the neutral axis of the tubular struts 418).

[0066] In some examples, the tubular struts 418 disposed between adjacent support segments 416 include a pair of tubular struts 418 disposed on opposite sides of adjacent support segments 416. In addition, longitudinally adjacent pairs of tubular struts 418 (e.g., pairs of tubular struts 418 separated by support segments 416) can be offset 90 degrees relative to each other in the circumferential direction so that every other segment of the axial support structure 414 can bend along the same axis, and the axial support structure 414 can bend along two axes (e.g., pitch and yaw). In other examples, for a three-guy wire 410 configuration, longitudinally adjacent pairs of tubular struts 418 can be offset 120 degrees relative to each other in the circumferential direction. Other suitable additional guy wire 410 configurations can also be utilized.

[0067] Each support segment 416 receives a pull wire 410 therethrough. In some examples, the support segment 416 includes pull wire openings 420 extending longitudinally therethrough corresponding to the number and circumferential position of the pull wires 410. The pull wire openings 420 may take any suitable form. For example, the pull wire openings 420 may be as follows: Figure 6A-6D The holes are shown in solid lines.

[0068] In another example, the pull wire opening 420 may be Figure 7 The groove 421 shown in FIG. 4 is open through the outer surface 422 of the support segment 416. The groove 421 may have a hook shape, which allows the pull wire 410 to be fed laterally into the pull wire groove 421, rather than threading the wire through a hole. In some examples, the groove 421 opens through the inner surface 426 of the support segment 416 rather than the outer surface 422. In some examples, as shown in FIG. Figure 7 As shown, the orientation of the grooved wire opening 421 can be switched from one support segment 416 to the next support segment 416 to capture a wire (not shown) therein, such that the groove 421 extends in a sequential clockwise, counterclockwise pattern between adjacent support segments 416. The groove configuration can reduce assembly time and facilitate wire materials such as multi-filament materials or fiber materials that may get stuck when threading the wire through the hole.

[0069] These configurations can provide structures for support segments 416 radially inward and radially outward from respective puller wires 410 to engage and support the puller wires 410 during active and passive articulation movements. Each tubular strut 418 in the axial support structure 414 is aligned with an adjacent support segment 416 to receive one of the puller wires 410 therethrough.

[0070] In the above example with 90 degree offset tubular struts 418, the flexible elongated device 400 has four pull wires 410, wherein two of the pull wires 410 are received in every other pair of tubular struts 418 and the other two of the pull wires 410 are received in the opposing pair of tubular struts 418 to control articulation of the articulatable body portion 408 along the pitch and yaw axes. Thus, in this and other examples, one, two, or more pull wires 410 may extend between adjacent support segments 416 that are not received in one of the tubular struts 418.

[0071] In some embodiments, the flexible elongated device 400 may include 2, 3, 4, 5, 6 or more cables 410 to articulate the articulated body portion 408. More than four cables 410 provide articulation along the pitch axis and the yaw axis in addition to providing additional functionality or complex geometries (e.g., S-shaped curvatures). The tubular struts 418 may be distributed along the axial support structure 414 to accommodate the desired articulation bends and / or patterns.

[0072] In some examples, the support segment 416 and the tubular strut 418 are separate components. In the above configuration with the pull wire 410 extending through the support segment 416 and the tubular strut 418, the pull wire 410 effectively ensures that the support segment 416 and the tubular strut 418 remain in a proper position relative to each other and provides an axial support structure 414 with reliable bending and axial stiffness.

[0073] like Figure 4 and Figure 6A-6D As shown, the flexible elongated device 400 may include an inner body member 424 extending through an axial support structure 414. In this example, the support segment 416 may have an inner surface 426 defining a central hole 428, the central hole being sized to receive the inner body member 424 therethrough, and the tubular struts 418 are circumferentially arranged around the central hole 428. For example, the support segment 416 may have an annular shape. Other examples (such as those without a central hole) may be applicable to other steerable tools such as cardiac mapping catheters, or non-medical steerable tools such as borescopes or pipefitters.

[0074] Depending on manufacturing requirements or desired configuration, support segment 416 may include a protrusion 429 that extends into central bore 428 to accommodate pull wire opening 420 while also minimizing the depth of adjacent areas of support segment 416. Alternatively, support segment 416 may have a uniform thickness sufficient to accommodate pull wire opening 420.

[0075] In some examples, the inner body member 424 can define or include a lumen 430 extending through the flexible body 402. The lumen 430 can provide a delivery channel for a medical tool (e.g., an endoscope, a biopsy needle, an endobronchial ultrasound (EBUS) probe, an ablation tool, an electroporation tool, a chemical delivery tool, etc.) to be inserted through the flexible body 402.

[0076] The flexible elongated device 400 may also include an outer sheath 432 disposed above the inner body member 424 and the axial support structure 414 to at least partially define the outer surface of the flexible body 402. The outer sheath 432 may be made of any suitable polymer, metal, or composite material, including polyurethanes of various hardnesses such as high hardness polyurethane, or a hard material having a stiffness or hardness higher than polyurethane. Suitable examples may include nylon, polyetheretherketone (PEEK), etc. The outer sheath 432 may be deposited onto the inner body member 424 and the axial support structure 414 by any suitable method including lamination, extrusion, etc.

[0077] like Figure 5 As shown, the flexible elongated device 400 may include one or more component wires 434 extending along its length. The component wires may include components of the flexible elongated device 400 (e.g., shape sensors) or portions of components located farther away (e.g., wiring for sensors or other electronic devices, illumination fibers for imaging devices, fluid lines, etc.). In examples with multiple component wires 434, the wires 434 may extend separately along the flexible elongated device 400, or may be bundled together. The component wires 434 may have any desired function. In some examples, the flexible elongated device 400 may include one or more of a shape sensor (e.g., a fiber optic shape sensor), an imaging device, a wire, an illumination fiber, etc.

[0078] In embodiments having an inner body member 424 and a support segment 416 having an aperture 428, one or more component wires 434 may extend between an inner surface 426 of the support segment 416 and an outer surface of the inner body member 424. In one form, the one or more component wires 434 extend longitudinally along the flexible body 402 in the proximal and distal segments 404, 406 in a direction substantially parallel to the pull wire 410.

[0079] In another form, one or more component wires 434 have a helical shape within the articulatable body portion 408 between the axial support structure 414 and the inner body member 424. The helical shape facilitates minimizing the tensile and compressive forces exerted on the component wires having a greater degree of longitudinal orientation due to the bending of the articulatable body portion 408 during full circumferential rotation. In one example, if the component wire 434 is or includes a shape sensor having a helical shape, the system (e.g., a control system coupled to the shape sensor) is provided with a volumetric representation of the articulatable body portion 408 based on data received from the shape sensor.

[0080] In some embodiments, the support segment 416 can be sized such that the diameter of the center hole 428 is larger than the outer diameter of the inner body member 424, so that the component wire 434 can be set at any circumferential location. In other embodiments, the center hole 428 can be relatively small, so that there is only a gap between the inner body member 424 and the inner surface 426 of the center hole when the inner body member 424 is off-center. In these embodiments, the inner body member 424 can be offset to a uniform radial / circumferential position relative to the support segment 416 and the inner body member 424 to allow one or more component wires 434 to extend longitudinally along the inner body member 424. Alternatively, as Figure 6A-6D As shown, the inner body member 424 can have a spiral configuration within the articulated body portion 408 and the axial support structure 414, so that a portion 436 of the support segment inner surface 426 that is separated from the inner body member 424 of the adjacent support segment 416 is offset in the circumferential direction. The circumferential offset relative to the adjacent support segment 416 forms a spiral shape on one or more component lines 434.

[0081] The support segment 416 can be made of any suitable material, including a low friction material. In some examples, the support segment 416 can be made of a polymer material such as polyoxymethylene (POM), also known as acetal, or a plated metal.

[0082] The tubular strut 418 can be made of any suitable material, including low friction materials. In some examples, the tubular strut 418 can be made of a polymer material such as polyimide doped with polytetrafluoroethylene (PTFE), or a plated metal. The tubular strut 418 can also have a variety of suitable forms, including braided metal, coils, springs, etc.

[0083] Although some exemplary axial support structures are described herein, the helical shape of one or more component wires 434 within the axial support structure and the helical configuration of the articulatable body portion 408 of the flexible elongated device 402 may be utilized with other configurations of axial support structures. Other exemplary axial support structures are described in the following: U.S. Patent Application Serial No. 16 / 932,196 (filed on July 17, 2020), U.S. Patent Application Serial No. 16 / 473,439 (filed on June 25, 2019), U.S. Patent Application Serial No. 15 / 685,979 (filed on August 24, 2017), and U.S. Provisional Patent Application 62 / 535,673 (filed on July 21, 2017), all of which are incorporated herein by reference in their entirety.

[0084] In any of the above examples, the flexible elongated device 400 can include a plurality of tubes 438 bonded or otherwise coupled to its proximal section 404. The tubes 438 are aligned with the pull wires 410 and provide a structure through which the pull wires 410 extend in the proximal section 404. In some examples, the tubes 438 extend longitudinally along the inner body member 424 to support the pull wires 410. For example, the tubes 438 can be bonded to the inner body member 424 by any suitable material such as a water-based polyimide, an epoxy resin, an adhesive (e.g., UV-curable), and the like.

[0085] One or more components of the embodiments discussed in the present disclosure, such as the control system 112, may be implemented using software executed on one or more processors of a computer system. The software may include code that, when executed by one or more processors, may configure one or more processors to perform various functions as discussed herein. The code may be stored in a non-transitory computer-readable storage medium (e.g., a memory, a magnetic storage device, an optical storage device, a solid-state storage device, etc.). The computer-readable storage medium may be part of a computer-readable storage device, such as an electronic circuit, a semiconductor device, a semiconductor storage device, a read-only memory (ROM), a flash memory, an erasable programmable read-only memory (EPROM); a floppy disk, a CD-ROM, an optical disk, a hard disk, or other storage device. The code may be downloaded via a computer network (such as the Internet, an intranet, etc.) for storage on a computer-readable storage medium. The code may be executed by any of a variety of centralized or distributed data processing architectures. The programming instructions of the code may be implemented as many independent programs or subroutines, or they may be integrated into many other aspects of the system described herein. Wired and / or wireless connections may be used to connect the components of the computing system discussed herein. In some examples, the wireless connection may use wireless communication protocols such as Bluetooth, Near Field Communication (NFC), Infrared Data Association (IrDA), Home RF (HomeRF), IEEE802.11, Digital Enhanced Cordless Telecommunications (DECT), and Wireless Medical Telemetry Service (WMTS).

[0086] Various general-purpose computer systems can be used to perform one or more processes, methods or functions described herein. In addition or alternatively, various special-purpose computer systems can be used to perform one or more processes, methods or functions described herein. In addition, various programming languages ​​can be used to implement one or more processes, methods or functions described herein.

[0087] Although some embodiments and examples are described above and shown in the accompanying drawings, it should be understood that such embodiments and examples are merely illustrative and are not limited to the specific constructions and arrangements shown and described, because those skilled in the art will understand various other alternatives, modifications and equivalents.

Claims

1. A flexible elongated device comprising: an elongated body having an articulatable body portion; as well as The axial support structure in the hingeable main body portion, the axial support structure comprising: transverse support segments spaced longitudinally along the articulatable body portion, each support segment receiving a plurality of tension wires for controlling articulation of the articulatable body portion; Tubular struts are disposed between adjacent support segments, adjacent tubular struts separated by one of the support segments being circumferentially offset relative to each other, each tubular strut receiving a pull wire.

2. A flexible elongated device according to claim 1, wherein: The tubular struts disposed between the adjacent support segments include a pair of tubular struts disposed on circumferentially opposite sides of the adjacent support segments such that pull wires received within the pair of tubular struts control articulation of the articulatable body portion along an axis.

3. A flexible elongated device according to claim 2, wherein: Adjacent pairs of tubular struts separated by one of the support segments are circumferentially offset 90 degrees relative to each other such that tension wires received within the adjacent pairs of tubular struts control articulation of the articulatable body portion along the pitch and yaw axes.

4. The flexible elongated device according to claim 1, wherein: Adjacent support segments receive at least one pull wire that is not received within one of the tubular struts disposed between the adjacent support segments.

5. The flexible, elongated device of claim 1 further comprising four pull wires, wherein adjacent pairs of tubular struts are circumferentially offset 90 degrees relative to one another to allow for pitch and yaw articulation of the articulatable body portion.

6. The flexible, elongated device of claim 1, further comprising three pull wires, wherein adjacent pairs of tubular struts are circumferentially offset 120 degrees relative to each other to allow articulation of the articulatable body portion.

7. A flexible elongated device according to any one of claims 1 to 6, wherein: The support segment defines a wire hole extending therethrough for the plurality of wires.

8. A flexible elongated device according to any one of claims 1 to 6, wherein: The support segment defines a wire draw groove extending therethrough for the plurality of draw wires.

9. A flexible elongated device according to any one of claims 1 to 6, wherein: The elongated body includes an inner body member defining a lumen, and each support segment defines a central aperture receiving the inner body member therethrough.

10. The flexible, elongated device of claim 9, further comprising a component line extending between the inner body member and a surface of the support segment defining the central aperture thereof.

11. A flexible elongated device according to claim 10, wherein: The component wire extends in a helical shape within the hingeable body portion.

12. A flexible elongated device according to claim 11, wherein: The inner body member has a helical configuration within the articulatable body portion such that portions of the surfaces of the support segments defining the central apertures thereof spaced from the inner body member are circumferentially offset in adjacent support segments.

13. The flexible elongated device of claim 11, wherein: The component line includes a shape sensor, the helical shape of the shape sensor providing a volumetric representation of the articulatable body portion.

14. The flexible elongated device of claim 10, wherein: The component line includes at least one of a wire or an optical fiber.

15. The flexible elongated device of claim 10, wherein: The component wire includes a plurality of component wires.

16. A flexible elongated device according to any one of claims 1 to 6, wherein: The tubular struts comprise a polymer material.

17. A flexible elongated device according to any one of claims 1 to 6, wherein: The tubular struts include one or more of plated metal, braided metal, coiled tubing, or springs.

18. A flexible elongate device according to any one of claims 1 to 6, wherein: The support segment comprises a polymer or a plated metal.

19. A flexible elongated device according to any one of claims 1 to 6, wherein: The support section and the tubular strut are independent components.

20. A flexible elongate device according to any one of the preceding claims, wherein: The elongated body also includes an outer sheath disposed over the axial support structure.

21. A flexible elongate device according to any one of claims 1 to 6, wherein: The elongated body includes a proximal section and a distal section, the distal section including the articulatable body portion.

22. The flexible, elongated device of claim 21, further comprising a plurality of tubes bonded to the proximal section of the elongated body, each tube of the plurality of tubes being configured to receive one of the plurality of pull wires.

23. The flexible, elongated device according to any one of claims 1 to 6, further comprising a control structure coupled to the elongated body distal to the axial support structure, the control structure being attached to the plurality of pull wires to control articulation of the articulatable body portion.

24. A flexible elongated device comprising: an elongated body including an articulatable body portion including an axial support structure and an inner body member within the axial support structure; as well as a component wire within the axial support structure, the component wire extending in a helical shape around the inner body member; Wherein, the inner body member has a helical configuration to accommodate the helical shape of the component line within the axial support structure.

25. A flexible elongate device according to claim 24, wherein: The axial support structure comprises: support segments spaced longitudinally along the articulatable body portion, each support segment receiving a plurality of pull wires for controlling articulation of the articulatable body portion, the support segments defining a central aperture for receiving the inner body member therethrough; and tubular struts disposed between adjacent support segments, adjacent tubular struts separated by one of the support segments being offset relative to each other in a circumferential direction, each tubular strut receiving a pull wire.

26. A flexible elongate device according to claim 25, wherein: The support segment defines a wire hole extending therethrough for the plurality of wires.

27. A flexible elongated device according to claim 25, wherein: The support segment defines a wire draw groove extending therethrough for the plurality of draw wires.

28. The flexible elongated device of claim 25, wherein: The tubular struts disposed between adjacent support segments include a pair of tubular struts disposed on circumferentially opposite sides of the adjacent support segments such that pull wires received within the pair of tubular struts control articulation of the articulatable body portion along an axis.

29. A flexible elongate device according to claim 28, wherein: Adjacent pairs of tubular struts separated by one of the support segments are circumferentially offset 90 degrees relative to each other such that tension wires received within the adjacent pairs of tubular struts control articulation of the articulatable body portion along the pitch and yaw axes.

30. A flexible elongate device according to any one of claims 25 to 29, further comprising four pull wires, wherein adjacent pairs of tubular struts are circumferentially offset 90 degrees relative to each other to allow articulation of the articulatable body portion in pitch and yaw.

31. The flexible elongated device of claim 28, wherein: Adjacent pairs of tubular struts separated by one of the support segments are circumferentially offset 120 degrees relative to one another such that pull wires received within the adjacent pairs of tubular struts control articulation of the articulatable body portion about a plurality of axes.

32. A flexible elongate device according to any one of claims 25 to 29, wherein: Adjacent support segments receive at least one pull wire that is not received within one of the tubular struts disposed between the adjacent support segments.

33. A flexible elongate device according to any one of claims 25 to 29, wherein: The tubular struts comprise a polymer material.

34. A flexible elongate device according to any one of claims 25 to 29, wherein: The tubular struts include one or more of plated metal, braided metal, coiled tubing, or springs.

35. A flexible elongate device according to any one of claims 25 to 29, wherein: The support segment comprises a polymer or a plated metal.

36. A flexible elongate device according to any one of claims 25 to 29, wherein: The support section and the tubular support rod are independent components.

37. A flexible, elongated device according to any one of claims 25 to 29, further comprising a control structure coupled to the elongated body distal to the axial support structure, the control structure being attached to the plurality of pull wires to control articulation of the articulatable body portion.

38. A flexible elongate device according to any one of claims 25 to 29, wherein: The component line includes a shape sensor, the helical shape of the shape sensor providing a volumetric representation of the articulatable body portion.

39. A flexible elongate device according to any one of claims 25 to 29, wherein: The component line includes at least one of a wire or an optical fiber.

40. A flexible elongate device according to any one of claims 25 to 29, wherein: The component wire includes a plurality of component wires.

41. A flexible elongate device according to any one of claims 25 to 29, wherein: The inner body member defines a lumen.

42. A flexible elongate device according to any one of claims 25 to 29, wherein: The elongated body also includes an outer sheath disposed over the axial support structure.

43. A flexible elongate device according to any one of claims 25 to 29, wherein: The elongated body includes a proximal section and a distal section, the distal section including the articulatable body portion.

44. The flexible, elongated device of claim 43, further comprising a plurality of tubes bonded to the proximal section of the elongated body, each tube of the plurality of tubes receiving one of the plurality of pull wires.

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