Flexible elongate device with articulatable body portion support structure

Abstract

The invention relates to a flexible elongate device with an articulatable body portion support structure. A 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 can include links longitudinally stacked on one another, wherein each of the links includes a body defining a plurality of drawing wire openings, an outwardly projecting hinge, and a socket. The socket is circumferentially offset relative to the hinge and is configured to receive the hinge of one of the chain links therein. The flexible elongate device can include a distal member disposed at a distal end of the axial support structure, a proximal member disposed at a proximal end of the axial support structure, and a braided sheath surrounding the axial support structure within the articulatable body portion, wherein an end of the braided sheath is coupled to the distal member and the proximal member.

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 damage 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 anatomy or through one or more surgical incisions. Through these natural orifices or incisions, physicians can insert minimally invasive medical instruments (including surgical instruments, diagnostic instruments, therapeutic instruments, and / or biopsy instruments) 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 pathway and navigated toward an area of ​​interest in the patient's anatomy. 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 some embodiments, a flexible, elongated device is described herein, comprising an elongated body having an articulated body portion and an axial support structure within the articulated body portion. The axial support structure comprises a plurality of links / links stacked longitudinally on each other. Each of the plurality of links comprises a body having a first end and a second end, wherein the body defines a plurality of pull wire openings extending therethrough to receive a plurality of pull wires controlling the articulation of the articulated body portion. Each of the plurality of links also comprises a hinge protruding outwardly from the first end of the body and a socket at the second end of the body, the socket being circumferentially offset relative to the hinge and configured to receive a hinge of one of the links therein. The body can also define a pull wire relief recess in the axial end of the body, the pull wire relief recess being aligned with a pull wire opening in the plurality of pull wire openings transverse to the bending axis of the interface between the adjacent hinge and the socket.

[0005] According to some embodiments, the present invention describes a flexible, elongated device comprising an elongated body having an articulated body portion, an axial support structure within the articulated body portion, a distal member disposed at the distal end of the axial support structure, a proximal member disposed at the proximal end of the axial support structure, and a braided sheath surrounding the axial support structure within the articulated body portion, wherein ends of the braided sheath are coupled to the distal member and the proximal member.

[0006] Each link of the plurality of links defines a hole; and the hinge includes opposing frustoconical or spherical portions aligned across the hole.

[0007] The diameter of the holes is between 2.45 mm and 2.8 mm.

[0008] Each of the plurality of links has an outer diameter between 3.81 mm and 3.66 mm.

[0009] The plurality of pull wire openings include a low friction sleeve or coating.

[0010] Each of the plurality of chain links has a coating or layer for reducing friction.

[0011] The articulation angle of adjacent links among the plurality of links is a combined angle of adjacent end faces of the adjacent links.

[0012] One of the end surfaces of the plurality of links is flat.

[0013] The axial support structure includes a plurality of hinge angles.

[0014] The maximum articulation angle of the axial support structure is provided by a distal link of the plurality of links.

[0015] The plurality of links comprise metal.

[0016] The plurality of links comprises a polymer.

[0017] The plurality of links do not contain nitinol.

[0018] The plurality of links do not interlock.

[0019] The articulated body portion further includes a distal member and a proximal member, the plurality of links being longitudinally stacked with each other between the distal member and the proximal member; and the articulated body portion further includes a braided sheath having ends coupled to the distal member and the proximal member to keep the plurality of links engaged with each other.

[0020] The ends of the braided sheath are welded to the distal member and the proximal member.

[0021] Each of the plurality of links is identical.

[0022] A distal link of the plurality of links has a shortened longitudinal length relative to other links of the plurality of links.

[0023] The articulatable body portion includes a control structure disposed distally of the axial support structure, and at least two of the plurality of pull wires are coupled to the control structure.

[0024] At least two of the plurality of pull wires are coupled to distal links of the plurality of links.

[0025] The distal link has a shortened longitudinal length relative to other links of the plurality of links.

[0026] The articulatable body portion includes a distal section of the elongated body.

[0027] Each of the plurality of links has a ground outer surface.

[0028] According to some embodiments, the present invention describes a flexible, elongated device comprising: an elongated body having an articulated body portion; an axial support structure within the articulated body portion; a distal member disposed at the distal end of the axial support structure; a proximal member disposed at the proximal end of the axial support structure; and a braided sheath surrounding the axial support structure within the articulated body portion, the ends of the braided sheath being coupled to the distal member and the proximal member.

[0029] The ends of the braided sheath are coupled to the distal member and the proximal member by a plurality of welds.

[0030] The plurality of welds are disposed at intersections of fibers of the braided sheath.

[0031] The plurality of welds includes at least one weld for each fiber of the braided sheath at both ends of the braided sheath.

[0032] The plurality of welds are laser welds.

[0033] The plurality of welds are resistance welds.

[0034] The ends of the braided sheath are coupled to the distal and proximal members by solder.

[0035] The distal member includes a control structure having a pull wire attached thereto, the pull wire being configured to control articulation of the articulatable body portion.

[0036] The proximal member includes a stop; and further includes a coil coupled to the stop.

[0037] The braided sheath is heat treated stainless steel.

[0038] The flexible elongated device also includes a jacket disposed over the braided sheath.

[0039] The axial support structure includes a plurality of links stacked longitudinally on each other, each of the plurality of links including: a body having a first end and a second end, the body defining a plurality of pull wire openings extending therethrough to receive a plurality of pull wires for controlling the articulation of the hingeable body portion; a hinge protruding outward from the first end of the body, an end surface of the first end of the body being angled laterally away from the hinge; and a socket at the second end of the body, the socket being circumferentially offset relative to the hinge and configured to receive a hinge of one of the links therein.

[0040] The hinge and the socket are offset 90 degrees relative to each other; so that the plurality of pull wires control the articulation of the articulated body portion along the pitch axis and the yaw axis.

[0041] The hinge includes an inwardly tapered surface configured to center adjacent links of the plurality of links when the sockets of the adjacent links are disposed on the hinge.

[0042] The elongated body includes an inner body member defining a cavity; and each link of the plurality of links defines a bore that receives the inner body member.

[0043] The hinge includes opposing portions aligned across the aperture.

[0044] The body further defines a pull wire relief recess in an axial end of the body, the pull wire relief recess being aligned with a pull wire opening of the plurality of pull wire openings transverse to a bending axis of an adjacent hinge and socket interface.

[0045] The plurality of pull wire openings have an expanded interior dimension toward one end parallel to an axis of curvature of an adjacent hinge to socket interface.

[0046] The body of each of the plurality of links defines three component openings extending therethrough, and adjacent links of the plurality of links have two component openings that are aligned to provide a longitudinal path through the axial support structure.

[0047] The articulation angle of adjacent links among the plurality of links is a combined angle of adjacent end faces of the adjacent links.

[0048] The axial support structure includes a plurality of hinge angles.

[0049] The plurality of links do not interlock.

[0050] Each of the plurality of links is identical.

[0051] A distal link of the plurality of links has a shortened longitudinal length relative to other links of the plurality of links.

[0052] At least two of the plurality of pull wires are coupled to the distal member.

[0053] At least two of the plurality of pull wires are coupled to distal links of the plurality of links.

[0054] The distal link has a shortened longitudinal length relative to other links of the plurality of links.

[0055] The articulatable body portion includes a distal section of the elongated body.

[0056] It should be understood that both the foregoing general description and the following detailed description are illustrative and explanatory in nature, and are intended to provide an understanding of the present disclosure without limiting the scope of the present disclosure. In this regard, additional aspects, features and advantages of the present disclosure will be apparent to those skilled in the art based on the following detailed description. BRIEF DESCRIPTION OF THE DRAWINGS

[0057] Figure 1 is a simplified diagram of a medical system according to some embodiments.

[0058] Figure 2A is a simplified diagram of a medical device system according to some embodiments.

[0059] Figure 2B is a simplified diagram of a medical device including a medical tool within an elongated device according to some embodiments.

[0060] 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.

[0061] Figure 4A is a cross-sectional perspective view of a flexible elongated device according to some embodiments.

[0062] Figure 4B is a diagram showing an axial support structure with a braided sheath according to some embodiments Figure 4A A cross-sectional perspective view of a flexible elongated device.

[0063] Figure 4C A braided sheath is shown welded to a distal member according to some embodiments. Figure 4B A cross-sectional perspective view of a flexible elongated device.

[0064] Figure 4D A braided sheath is shown welded to a proximal member according to some embodiments. Figure 4BA cross-sectional perspective view of a flexible elongated device.

[0065] Figure 5A is a cross-sectional perspective view of a flexible elongated device showing an axial support structure according to some embodiments.

[0066] Figure 5B According to some embodiments Figure 5A A top perspective view of a link for the axial support structure of a flexible elongated device.

[0067] Figure 5C According to some embodiments Figure 5A Bottom perspective view of a link for the axial support structure of a flexible elongated device.

[0068] Figure 5D According to some embodiments Figure 5A A perspective view of stacked links for the axial support structure of a flexible elongated device.

[0069] Figure 5E is a diagram showing a first example pull wire relief feature according to some embodiments Figure 5A Cross-sectional view of stacked links for axial support structure of flexible elongated device.

[0070] Fig. 5F is an illustration of a second example pull wire relief feature according to some embodiments Figure 5A Cross-sectional view of stacked links for axial support structure of flexible elongated device.

[0071] Figure 5G is an illustration showing a component line opening configuration according to some embodiments Figure 5A Cross-sectional view of stacked links for axial support structure of flexible elongated device.

[0072] Figure 5H According to some embodiments Figure 5A A cross-sectional perspective view of a distal member of a flexible, elongated device.

[0073] Figure 6 is an exploded perspective view of a second example distal member of a flexible elongated device according to some embodiments.

[0074] Figure 7 is an exploded perspective view of a third example distal member of a flexible elongated device according to some embodiments.

[0075] Embodiments of the present disclosure and their advantages will be best understood by referring to the following detailed description. It should be understood that the same reference numerals are used to identify the same elements shown in one or more figures, wherein the display thereof is for illustrating embodiments of the present disclosure and not for limiting thereof. DETAILED DESCRIPTION

[0076] In the following description, the specific details of some embodiments consistent with the present disclosure are described. Many specific details are described to provide a thorough understanding of the embodiments. However, it is obvious to those skilled in the art that some embodiments can be implemented without some or all of these specific details. The specific embodiments disclosed herein are intended to be illustrative, rather than restrictive. Those skilled in the art will appreciate that, although not specifically described herein, other elements also fall within the scope and spirit of the present disclosure. In addition, in order to avoid unnecessary repetition, one or more features shown and described in conjunction with an embodiment may be incorporated into other embodiments, unless specifically described otherwise or if these one or more features make the embodiments inoperative. In some cases, well-known methods, procedures, components and circuits are not described in detail to avoid unnecessary blurring of the various aspects of the embodiments.

[0077] The present disclosure describes various apparatuses and the state of the parts of apparatuses in three-dimensional space. As used herein, the term "position" refers to the position 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 rolling, pitching and yaw). As used herein, the term "posture" refers to the orientation 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 the object in at least one rotational degree of freedom (e.g., up to a total of six degrees of freedom). As used herein, the term "shape" refers to a group of postures, positions and / or orientations measured along an object. As used herein, the term "distal" refers to the position closer to the procedural site, and the term "proximal" refers to the position further away from the procedural site. Therefore, when an apparatus is used to perform a procedure according to design, the distal part or distal end of the apparatus is closer to the procedural site than the proximal part or proximal end of the apparatus.

[0078] A flexible, elongated device including an articulatable body portion may include an axial support structure that functions to maintain the neutral axis length of the articulatable body portion during articulation thereof and to support the articulatable body portion against 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 or other types of forces (e.g., external forces).

[0079] Some axial support structures may be formed by cutting material away from a tubular structure, which may have correspondingly high material and manufacturing costs. The axial support structures provided herein include links that have lower material and manufacturing costs than prior axial support structures.

[0080] The axial support structure provided herein includes a plurality of links stacked along the longitudinal axis of the flexible elongated device. Each link includes a hinge at one end and a socket at the opposite end, so that the hinge of one link is received in the socket of an adjacent link. The bending axis of the hinge extends laterally across the link, which allows the axial support structure to bend along a bending axis that is lateral to the neutral axis. In some examples, the hinge and the socket of each link can be circumferentially offset relative to each other (e.g., 60 degree offset, 72 degree offset, 90 degree offset, 120 degree offset, etc.) to allow the axial support structure, and therefore allow the articulated body portion to bend along multiple axes (e.g., pitch and yaw). In some examples, the hinge can include an inwardly tapered surface that helps to align the stacked links to a common centerline.

[0081] In some examples, the articulation of the articulated main body of the flexible elongated device can be achieved by manipulating the pull wire that is coupled to the control structure (e.g., control ring or tip portion) disposed in the articulated main body. In these examples, the chain link can include a pull wire opening extending through it so that the pull wire can pass through a plurality of chain links. In some examples, the chain link can be configured to reduce the stress and / or friction on the pull wire caused by the articulation of the chain link relative to each other. For example, the chain link can define a recess in the end face aligned with the pull wire opening. Adjacent chain links can have aligned recesses, thereby providing an increased bending radius for the pull wire to extend between the chain links during articulation. The recess can be helpful for the pull wire to extend through the chain link, and to be spaced apart from the bending axis to realize a specific articulation. In another example, when the pull wire opening extends to the end face of the chain link, the pull wire opening can have an expanded or increased internal dimension (e.g., transitioning from a circular cross section to an elongated groove cross section). Adjacent links can have aligned pull wire openings with expanded or increased internal dimensions to provide an increased bending radius for the pull wire to extend between the links during articulation. Pull wire openings with expanded or increased internal dimensions are helpful for the pull wire to extend through the links adjacent to the bending axis to achieve a particular articulation.

[0082] In some examples, the flexible elongated device may include an internal body member capable of defining a cavity for the flexible elongated device. In these examples, the link may be annular, and its inner diameter is sized to receive the internal body member passing therethrough. In addition, the flexible elongated device may include one or more component lines (e.g., wires, sensors, conductors, etc.) extending through the articulated body portion of the flexible elongated device. Thus, each link of the axial support structure may include one or more component slots to receive the component line passing therethrough. In one example, each link may include a plurality of component slots having a spaced configuration around the circumference of the link, so that when the link rotates relative to an adjacent link due to a hinge / socket bias, one of the component slots is aligned with one of the component slots of an adjacent link, thereby providing a continuous longitudinal path for the component line to pass through the axial support structure. In a further example, the flexible, elongated device can include two component lines and three component slots having a spaced configuration around the circumference of the link such that when the link rotates relative to an adjacent link due to the hinge / socket bias, two of the component slots align with two of the component slots of an adjacent link, thereby providing a continuous longitudinal path for the component line to pass through the axial support structure.

[0083] In some examples, the articulated body portion of the flexible elongated device can include a braided sheath disposed on an axial support structure of the articulated body portion. The braided sheath can support the articulated body portion and its axial support structure against stretching, and in some embodiments, against compressive forces that may be generated by handling, lubrication, sterilization, reprocessing, etc. The articulated body portion can include a proximal member (e.g., a stopper) and a distal member (e.g., a control structure), with the axial support structure located between them. The ends of the braided sheath are laser welded to the proximal member and the distal member so that the braided sheath extends over the articulated body portion and resists tension. The weld that secures the braided sheath to the proximal / distal member can be located at the intersection of the braided material.

[0084] Figure 1 is a simplified diagram of a medical system 100 according to some embodiments. The medical system 100 can be suitable for use in, for example, surgical procedures, diagnostic (e.g., biopsy) procedures, or therapeutic (e.g., ablation, electroporation, etc.) procedures. Although some embodiments of such procedures are provided herein, any reference to medical devices or surgical devices and medical methods or surgical methods is non-limiting. The systems, devices, and methods described herein can 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 teleoperated systems, or robotic medical systems.

[0085] like Figure 1As 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 body of the patient P via an opening in the body of the patient P. 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 and / or positioned near the patient table T. 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 examples, the main assembly 106 allows the operator O to view a procedure site or other graphic or information display. In some examples, the manipulator assembly 102 may be excluded from the medical system 100, and the instrument 104 may be directly controlled by the operator O. In some examples, the manipulator assembly 102 may be manually controlled by the operator O. Direct operator controls may include various handles and operator interfaces for the handheld instrument 104 .

[0086] The main assembly 106 can be located at a surgeon's console that is near (e.g., in the same room as) a patient table T where the patient P is located, such as on one side of the patient table T. In some examples, the main assembly 106 is remote from the patient table T, such as 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, a trackball, a scroll wheel, a directional pad, a button, a data glove, a trigger gun, a manually operated controller, a voice recognition device, a motion or presence sensor, and / or the like.

[0087] The manipulator assembly 102 supports the medical device 104 and may include a linkage motion structure that provides an assembly / set-up 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 an anatomical orifice that is naturally occurring or surgically created. The actuator may control the articulation of the medical device 104, such as by moving the distal end (or any other portion) of the medical device 104 with multiple degrees of freedom. These degrees of freedom can include three degrees of freedom for linear motion (e.g., linear motion along the X, Y, Z Cartesian axes) and three degrees of freedom for rotational motion (e.g., rotation about the X, Y, Z Cartesian axes). One or more actuators can control the rotation of the medical device about the longitudinal axis. The actuator can also be used to move an articulated end effector of the medical device 104, such as for grasping tissue in the jaws of a biopsy device and / or the like, and can also 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.).

[0088] The medical system 100 may include a sensor system 108 having one or more subsystems for receiving information about the manipulator assembly 102 and / or the medical device 104. Such subsystems may include: a position sensor system (e.g., using an electromagnetic (EM) sensor or other type of sensor that detects position or location); a shape sensor system for determining the position, orientation, speed, velocity, posture, and / or shape of a distal end and / or one or more segments along the flexible body of the medical device 104; a visualization system (e.g., using a color imaging device, an infrared imaging device, an ultrasound imaging device, an X-ray imaging device, a 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; and / or an actuator position sensor that describes the rotation and / or orientation of an actuator that controls the medical device 104, such as a resolver, encoder, potentiometer, etc.

[0089] Medical system 100 may include display system 110 for displaying images or representations of a procedure site and medical instrument 104. Display system 110 and primary assembly 106 may be oriented so that physician O can control medical instrument 104 and primary assembly 106 using telepresence perception.

[0090] In some embodiments, the medical device 104 may include a visualization system that 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. The concurrent images may be, for example, two-dimensional images or three-dimensional images captured by an endoscope positioned within the anatomical procedure site. In some examples, the visualization system may include an endoscope component that may be integrally or removably coupled to the medical device 104. Additionally or alternatively, a separate endoscope attached to a separate manipulator assembly may be used in conjunction with the medical device 104 to image the procedure site. The visualization system may be implemented as hardware, firmware, software, or a combination thereof that interacts with or is otherwise executed by one or more computer processors (such as a computer processor of the control system 112).

[0091] 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 the operator O with a telepresence perception. For example, an image captured by an imaging device at a distal portion of the medical device 104 may be presented by the display system 110, thereby providing the operator O with a perception of being at the distal portion of the medical device 104. The input to the main assembly 106 provided by the operator O may move the distal portion of the medical device 104 in a manner corresponding to the nature of the input (e.g., when the trackball rolls to the right, the distal tip turns to the right) and cause the perspective of the image captured by the imaging device at the distal portion of the medical device 104 to change accordingly. Thus, when the medical device 104 is moved using the main assembly 106, the operator O's telepresence perception is maintained. The operator O is able to manipulate the medical device 104 and the hand controller of the main assembly 106 as if viewing the workspace under a substantially realistic perception, thereby simulating the operator's experience of physically manipulating the medical device 104 in the patient's anatomy.

[0092] In some examples, the display system 110 can present a virtual image of the procedural site, the virtual image being created using image data recorded preoperatively (e.g., before a procedure performed by the medical device system 200) or intraoperatively (e.g., concurrently with a procedure performed by the medical device system 200), such as image data generated using computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET), fluoroscopy, infrared thermography, ultrasound, optical coherence tomography (OCT), thermal imaging, impedance imaging, laser imaging, nanotube X-ray imaging, and / or similar techniques. The virtual image can include a two-dimensional, three-dimensional, or higher-dimensional (e.g., including, for example, time-based or velocity-based) image. In some examples, one or more models are created from preoperative or intraoperative image data sets, and the virtual image is generated using the one or more models.

[0093] In some examples, for the purpose of imaging-guided medical procedures, the display system 110 can display a virtual image generated based on the position of the tracked medical device 104. For example, the position of the tracked medical device 104 can be registered (e.g., dynamically referenced) to a model generated using preoperative or intraoperative images, with different portions of the model corresponding to different locations of the patient's anatomy. As the medical device 104 moves through the patient's anatomy, the registration is used to determine the portion of the model that corresponds to the position and / or perspective of the medical device 104, and a virtual image is generated using the determined portion of the model. Doing so can present a virtual image of the internal procedure site to the operator O from the viewpoint of the medical device 104 that corresponds to the position of the tracked medical device 104.

[0094] Medical system 100 may also include a control system 112, which may include processing circuitry to implement 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 the instructions) that, when executed by at least one processor, configure the one or more processors to implement some or all of the methods or functionality discussed herein. Although control system 112 may be implemented in a variety of embodiments, it is contemplated that control system 112 may be implemented in a variety of embodiments, such as in the embodiments of FIG. 1 . Figure 1106, but the control system 112 may include two or more separate data processing circuits, with a portion of the processing performed at the manipulator assembly 102 and another portion of the processing performed at the main assembly 106, and / or the like. 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.

[0095] 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 master assembly 106. In some examples, control system 112 can transmit a signal instructing one or more actuators of manipulator assembly 102 to move medical device 104. In some examples, control system 112 can transmit an information display regarding the feedback to display system 110 for presentation or perform other types of actions based on the feedback.

[0096] 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 an acquired preoperative or intraoperative data set of the anatomical pathway of the patient P. The control system 112 or a separate computing device may convert the recorded image into a model of the patient's anatomy using only programming instructions or in combination with operator input. The model may include a two-dimensional or three-dimensional synthetic representation of a segmentation of a partial or entire anatomical organ or anatomical region. The image data set may be associated with the synthetic representation. The virtual visualization system may obtain sensor data from the sensor system 108, which is used to calculate the (e.g., approximate) position of the medical device 104 relative to the anatomy of the patient P. The sensor system 108 may be used to register and display the medical device 104 and the preoperative or intraoperative recorded images. For example, PCT Publication WO 2016 / 191298 (published on December 1, 2016, entitled "Systems and Methods of Registration for ImageGuided Surgery"), which is incorporated herein by reference in its entirety, discloses an example system.

[0097] During a virtual navigation procedure, the sensor system 108 can be used to calculate the (e.g., approximate) position of the medical device 104 relative to the anatomy of the patient P. The position can be used to generate a macro-level (e.g., external) tracking image of the anatomy of the patient P and a virtual internal image of the anatomy 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 medical devices and preoperatively recorded medical images. For example, U.S. Patent No. 8,900,131 (filed on 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, discloses an example system.

[0098] The medical system 100 may also include operating and support systems (not shown), such as lighting systems, steering control systems, flushing systems, and / or suction systems. In some embodiments, the medical system 100 may include more than one manipulator assembly and / or more than one main assembly. The exact number of manipulator assemblies may depend on factors such as the medical procedure and the space limitations within the procedure room. Multiple main assemblies may be co-located, or they may be located in different locations. Multiple main assemblies may allow more than one operator to control one or more manipulator assemblies in various combinations.

[0099] 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 serve as an example of a medical device 104 of the medical system 100. The medical system 100 can be a teleoperation system, a non-teleoperation system, or a hybrid teleoperation and non-teleoperation system, as described in reference Figure 1 The visualization system 231, the tracking system 230 and the navigation system 232 are also Figure 2A , and is an example component 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 locations within an anatomical pathway of a patient (such as patient P).

[0100] The elongated device 202 is coupled to a drive unit 204. The elongated device 202 includes a channel 221 through which a medical tool 226 can be inserted. The elongated device 202 navigates within the patient's anatomy to deliver the medical tool 226 to a 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 flexible body 216 can have an outer diameter of approximately 3 mm. Other flexible body outer diameters can be larger or smaller.

[0101] 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 along one or more segments 224 of the flexible body 216, as described in further detail below. The tracking system 230 may include one or more sensors and / or imaging devices. The flexible body 216, such as the length between the distal end 218 and the proximal end 217, may include 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.

[0102] The tracking system 230 can track the distal end 218 and / or one or more 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., provided within an internal channel of the flexible body 216 or mounted externally along the flexible body 216). In some examples, the optical fiber can have a diameter of 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. Optical fibers including fiber Bragg gratings (FBGs) can be used to provide strain measurements in one or more dimensions on the structure. Various systems and methods for monitoring the shape and relative orientation of optical fibers 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"), the entire contents of which are incorporated herein by reference. The sensors in some embodiments may employ other suitable strain sensing techniques, such as Rayleigh scattering, Raman scattering, Brillouin scattering, and fluorescence scattering.

[0103] In some examples, the shape of the flexible body 216 can be determined using other techniques. For example, the history of the position and / or posture of the distal end 218 of the flexible body 216 can be used to reconstruct the shape of the flexible body 216 over a time interval (e.g., when the flexible body 216 is advanced or retracted within the patient's anatomy). In some examples, the tracking system 230 can alternatively and / or additionally track the distal end 218 of the flexible body 216 using the position sensor system 220. The position sensor system 220 can 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 of the position sensors of the position sensor system 220 can be varied to track different areas along the flexible body 216. In one example, the position sensor includes a conductive coil that may be affected by an externally generated electromagnetic field. Each coil of the orientation sensor system 220 can generate an induced electrical signal, the characteristics of which depend on the orientation and position of the coil relative to the externally generated electromagnetic field. The orientation sensor system 220 can measure one or more orientation coordinates and / or one or more orientation angles associated with one or more parts of the flexible body 216. In some examples, the orientation sensor system 220 can be configured and positioned to measure six degrees of freedom, for example, three orientation coordinates X, Y, and Z and three orientation angles indicating pitch, yaw, and roll of a base point. In some examples, the orientation sensor system 220 can be configured and positioned to measure five degrees of freedom, for example, three orientation coordinates X, Y, and Z and two orientation angles indicating pitch and yaw of a base point. Further description of an orientation sensor system that may be applicable to 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.

[0104] In some embodiments, tracking system 230 may alternatively and / or additionally rely on a collection of posture, position, and / or orientation data stored for a point of elongated device 202 and / or medical tool 226, captured during one or more cycles of alternating motion (such as breathing). This stored data may be used to develop shape information about flexible body 216. In some examples, a series of position sensors (not shown) (such as EM sensors similar to the sensors 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 examples, a history of data acquired from one or more of these position sensors during a procedure may be used to represent the shape of elongated device 202, particularly in situations where the anatomical pathway is generally static.

[0105] 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, and the like. The medical tool 226 can be deployed through the channel 221 of the flexible body 216 and manipulated at a procedural site within the anatomy. 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 tools, diagnostic tools, or therapeutic tools. In some examples, the medical tool 226 may include an end effector having a single working member (such as a scalpel, a blunt blade, an optical fiber, an electrode, and / or the like). Other end-type end effectors may include, for example, forceps, clamps, scissors, staplers, clip appliers, and / or the like. Other end effectors may further include electrically activated end effectors, such as electrosurgical electrodes, transducers, sensors, and / or the like.

[0106] The medical tool 226 can be a biopsy tool for removing a sample tissue or cell sample from a target anatomical location. In some examples, the biopsy tool is a flexible needle. The biopsy tool can also include a sheath that can surround the flexible needle to protect the inner surface of the needle and the channel 221 when the biopsy tool is in the channel 221. The medical tool 226 can be an image capture probe that includes a distal portion with a stereo camera or a single-view camera, which can be placed at or near the distal end 218 of the flexible body 216 for capturing images (e.g., still images or video images). The captured image can be processed by the visualization system 231 for display and / or provided to the tracking system 230, thereby supporting tracking of the distal end 218 of the flexible body 216 and / or one or more segments 224 of the flexible body 216. The image capture probe can include a cable for transmitting captured image data, and the cable is coupled to the imaging device at the distal portion of the image capture probe. In some examples, the image capture probe can include a fiber optic bundle coupled to a more proximal imaging device of the visualization system 231, such as a fiberscope. The image capture probe can be single-spectrum or multi-spectrum, for example, capturing image data in the form of one or more of the visible spectrum, near infrared spectrum, infrared spectrum, and / or ultraviolet spectrum. The image capture probe can also include one or more light emitters that provide illumination to facilitate image capture. In some examples, the image capture probe can use ultrasound, X-ray, fluoroscopy, CT, MRI, or other types of imaging techniques.

[0107] 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 within the flexible body 216 with another type of medical tool 226 that performs 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 within a separate channel. 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 when the procedure is complete. The medical tool 226 can be removed from the proximal end 217 of the flexible body 216 or from other optional instrument ports (not shown) along the flexible body 216.

[0108] In some examples, the elongated device 202 may include integrated imaging capabilities rather than utilizing a removable 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 215 may include one or more dedicated channels carrying (one or more) cables and / or (one or more) optical fibers between the distal end 218 and the visualization system 231. In this context, the medical device system 200 may perform imaging operations and tool operations simultaneously.

[0109] In some examples, the medical tool 226 can be controllably articulated. The medical tool 226 can house a cable (also referred to as a pull wire), a linkage, or other actuation controller (not shown) extending between its proximal and distal ends to controllably bend the distal end of the medical tool 226, such as discussed herein with respect to the flexible elongated device 202. The medical tool 226 can be coupled to the drive unit 204 and the manipulator assembly 102. In these examples, the elongated device 202 can be excluded from the medical device system 200 or can be a flexible device without controllable articulation. Steerable instruments or tools that may be suitable for use in some embodiments are further described in: 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"), which are incorporated herein by reference in their entirety.

[0110] The flexible body 216 of the elongated device 202 may also or alternatively house a cable, linkage, or other steering controller (not shown) extending between the drive unit 204 and the distal end 218 to controllably bend the distal end 218, such as, for example Figure 2AThe broken dashed outline 219 of the distal end 218 is shown. 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 left and right steering to control the yaw of the distal end 281. In these examples, the flexible elongated device 202 can be a steerable catheter. Examples of steerable catheters suitable for some embodiments are described in detail in PCT Publication WO 2019 / 018736 (published on January 24, 2019, entitled "Flexible Elongate Device Systems and Methods"), which is incorporated herein by reference in its entirety.

[0111] 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 a drive element (such as an actuator) of the remotely operated assembly and receives power from the drive element. 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 an operator to control the 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 can 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.

[0112] 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 navigate and treat other tissues via naturally occurring or surgically created connecting pathways in any of a variety of anatomical systems, including the colon, intestines, kidneys and calyces, brain, heart, circulatory system (including vasculature), and / or the like.

[0113] 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 examples, the real-time position information may be displayed on the display system 110 for controlling the medical instrument system 200. In some examples, the navigation system 232 may utilize the position information as feedback for positioning the medical instrument system 200. Various systems for registering and displaying surgical instruments using surgical images using fiber optic sensors suitable for use in some embodiments are provided in U.S. Pat. No. 8,900,131 (filed May 13, 2011, and 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.

[0114] 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 within the surgical environment 300 because the patient's overall movement is limited by sedation, restraints, and / or other means. The periodic anatomical movement of the patient P, including breathing and cardiac movement, may continue. Within the surgical environment 300, a medical device 304 is used to perform a medical procedure that 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 a registration procedure that associates the position, orientation, and / or posture data captured by the sensor system 108 to a desired (e.g., anatomical or system) reference system. The medical device 304 may be, for example, the medical device 104. In some examples, 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 that are sized and shaped to receive a medical tool.

[0115] 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 be movable with the instrument body 312, and the position of the proximal point 316 relative to a desired reference frame may be known (e.g., via a tracking sensor or other tracking device). The shape sensor 314 may measure the shape from the proximal point 316 to another point (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., provided within an internal channel or mounted externally). In some examples, the shape sensor 314 may be an optical fiber for generating shape information of the elongated device 310.

[0116] 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 conjunction with shape sensor 314, such as to improve the accuracy of shape sensing or to verify shape information.

[0117] The elongated device 310 can house cables, linkages, or other steering controls extending 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 left and right steering to control the yaw of the distal end 318. The instrument body 312 can include a drive input that is removably coupled to a drive element (such as an actuator) of a manipulator assembly and receives power from the drive element.

[0118] The instrument body 312 can be coupled to an instrument bracket 306. The instrument bracket 306 can be mounted to an insertion gantry 308 that is fixed within the surgical environment 300. Optionally, the insertion gantry 308 can be movable but have a known position within the surgical environment 300 (e.g., via a tracking sensor or other tracking device). The instrument bracket 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 motion (e.g., motion along the insertion axis A) and / or motion of the distal end 318 of the elongated device 310 in multiple directions (such as yaw, pitch, and / or roll). The instrument bracket 306 or the insertion gantry 308 can include an actuator, such as a servo motor, that controls the motion of the instrument bracket 306 along the insertion gantry 308.

[0119] The sensor device 320 can be a component of the sensor system 108 that can provide information about the orientation of the instrument body 312 as the instrument body 312 moves relative to the insertion gantry 308 along the insertion axis A. 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 gantry 306, thereby indicating the movement of the instrument body 312. In some embodiments, the insertion gantry 308 has a plurality of sensors such as Figure 3A and Figure 3B In some embodiments, the insertion carriage 308 can have a curved track or a combination of curved track sections and linear track sections.

[0120] Figure 3A The instrument body 312 and instrument bracket 306 are shown in a retracted orientation along the insertion gantry 308. In this retracted orientation, the proximal point 316 is located at an orientation L0 on the insertion axis A. The position of the proximal point 316 can be set to a zero value and / or other reference value to provide a base reference (e.g., corresponding to the origin of a desired reference system) to describe the orientation of the instrument bracket 306 along the insertion gantry 308. In the retracted orientation, the distal end 318 of the slender device 310 can be positioned exactly within the access orifice of the patient P. Also in the retracted orientation, 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 308, the instrument body 312 and the instrument cradle 306 have been advanced along the linear track of the insertion gantry 308, and the distal end 318 of the elongated 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 examples, the rotation and / or orientation of the actuator measured by the sensor device 320 indicating the movement of the instrument cradle 306 along the insertion gantry 308 and / or one or more position sensors associated with the instrument cradle 306 and / or the insertion gantry 308 can be used to determine the position L1 of the proximal point 316 relative to the position L0. In some examples, the position L1 can further be used as an indicator of the distance or insertion depth of the distal end 318 of the elongated device 310 inserted into the (one or more) channels of the anatomy of the patient P.

[0121] Figure 4A-4C Components of a flexible elongated device 400 are shown according to some embodiments. Figure 1-Figure 3B Consistent with some embodiments, flexible elongated device 400 may correspond to elongated device 202 of medical device system 200 .

[0122] Flexible elongated device 400 includes 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 the proximal section 404 and the distal section 406 can have any desired length. As above, the term "distal" refers to a location closer to a procedure site, while the term "proximal" refers to a location farther from a procedure site. Figure 4A As shown, the flexible body 420 can include a jacket 408 that extends along part or all of the length of the flexible elongated device 400 to provide an outer surface for the flexible elongated device 400. The jacket 408 can be made of any suitable polymer, metal, or composite material, including polyurethane of various hardnesses (e.g., high hardness polyurethane) or a harder material having a hardness or durometer higher than polyurethane. Suitable examples can include nylon, polyetheretherketone (PEEK), etc. The jacket 408 can be applied by any suitable method, including lamination, extrusion, etc.

[0123] The flexible elongated device 400 includes: an articulated body portion 410, which in some examples can be located in or form the distal section 406 of the flexible body 402; and an axial support structure 412 within the articulated body portion 410. The axial support structure 412 is configured to bend in response to the articulation of the articulated body portion 410 and to support the articulated body portion 410 against the axial load generated by the articulation. Specifically, the axial support structure 412 can prevent or reduce deformation, compression, and / or collapse of the articulated body portion 410 under axial load.

[0124] The flexible elongated device 400 can also include a distal member 414 disposed at the distal end of the axial support structure 412 and a proximal member 416 disposed at the proximal end of the axial support structure 412. In some examples, the flexible elongated device 400 can also include a braided sheath 418 that surrounds the axial support structure 412 within the articulated body portion 410. The ends of the braided sheath 418 are coupled to the distal member 414 and the proximal member 416. The braided sheath 418 can advantageously allow the articulated body portion 410 to withstand tension, such as tension generated by the preparation of the flexible elongated device 400 (e.g., removing packaging, applying coatings, cleaning, etc.) for use. Further, due to the flexible structure of the braided sheath, the braided sheath 418 does not significantly increase the bending stiffness of the articulated body portion 410.

[0125] like Figure 4B and Figure 4CAs shown, the end of the braided sheath 418 can be coupled to the distal member 414 and the proximal member 416 by a plurality of welds 420. In order to produce a strong bond, the weld 420 can be arranged at a position where the silk thread or fiber of the braided sheath 418 is provided and close contact between the distal member 414 / proximal member 416. In the shown form, the braided sheath 418 includes the silk thread / fiber woven with an over and under pattern. Therefore, at many points, the individual silk thread / fiber does not contact the distal member 414 / proximal member 416. In order to ensure contact, the weld 420 can be arranged above the intersection of the silk thread / fiber aligned above the distal member 414 / proximal member 416 or incorporated into these intersections. Additionally, the welds 420 can be sufficient and / or can be arranged so that each wire / fiber of the braided sheath 418 has a weld 420 with both the distal member 414 and the proximal member 416, whether welded to the members 414, 416 individually or as part of the intersection. The welds 420 can be arranged in the middle of the intersection, in a circle around the intersection, at the four corners of the intersection, etc. The welds 420 can be arranged in a repeating W-shaped pattern, a diamond pattern, and / or a zigzag pattern.

[0126] In some examples, weld 420 can be a laser weld. In other examples, weld 420 can be a resistance weld. To create a resistance weld, electrodes apply pressure and pass current to melt the wires / fibers aligned over distal member 414 / proximal member 416.

[0127] In some examples, the braided sheath 418 can be formed of stainless steel wire (e.g., 304 stainless steel). In some examples, the braided sheath 418 can be a stress-relieved heat-treated metal (e.g., heat-treated stainless steel) in order to set the braided sheath 418 in a shape (e.g., annular) suitable for welding to the cylindrical outer surfaces of the distal member 414 and the proximal member 416. For example, the braided sheath 418 can be quickly heated (e.g., heated up to 1000 degrees Fahrenheit / 538 degrees Celsius in 10 seconds), such as by an induction coil.

[0128] like Figure 4A-4C As shown, distal member 414 can include a control structure (discussed in more detail below) that realizes that articulated main body portion 410 can be attached to one or more pull wires to control the articulation of articulated main body portion 410. In some examples, distal member 414 is (for example, the farthest side) link of axial support structure. In other examples, distal member 414 is a one-piece structure, which includes the distal tip of flexible elongated device and the control structure attached to the pull wire. Further, proximal member 416 can be a stopper and / or a coupling structure of coil 422, and each coil 422 is configured to receive corresponding pull wire.

[0129] Figure 5A-5H Components of a flexible elongated device 500 are shown according to some embodiments. Figure 1-4C Consistent with some embodiments, flexible elongated device 500 may correspond to elongated device 202 and / or flexible elongated device 400 of medical device system 200 .

[0130] The flexible elongated device 500 includes a flexible body 502 extending from a proximal section 504 to a distal section 506. It should be understood that the flexible body 502 including the proximal section 504 and the distal section 506 can have any desired length. Although not shown, the flexible body 502 can include a jacket extending along part or all of the length of the flexible elongated device 500 to provide an outer surface of the flexible elongated device similar to the above-described examples.

[0131] The flexible elongated device 500 includes: an articulated body portion 510, which in some examples can be located in or form a distal section 506 of the flexible body 502; and an axial support structure 512 within the articulated body portion 510. The axial support structure 512 is configured to bend in response to the articulation of the articulated body portion 510 and to support the articulated body portion 510 against the axial load generated by the articulation. Specifically, the axial support structure 512 can prevent or reduce deformation, compression and / or collapse of the articulated body portion 510 under axial load. The flexible elongated device 500 can also include a distal member 514 disposed at the distal end of the axial support structure 512 and a proximal member 516 disposed at the proximal end of the axial support structure 512.

[0132] The axial support structure 512 includes a plurality of longitudinally stacked links 518. The axial support structure 512 can include any desired number of links 518 to provide a sufficient length of the articulated main body portion 510. Figure 5B and Figure 5C As shown, each link 518 includes a body having a first end 518a and a second end 518b. In order to allow the axial support structure 512 to bend, each link 518 includes a hinge 520 protruding outward from the first end 518a of the body and a socket 522 at the second end 518b of the body, and the socket 522 is configured to receive the hinge 520 of one of the links 518. The socket 522 is circumferentially offset at a certain angle relative to the hinge 520, so that the links 518 can be stacked on each other, and adjacent links 518 can be rotated relative to each other by the circumferential offset amount. The axial support structure 512 can be stacked by allowing adjacent links 518 to be stacked around a bending axis B ( Figure 5D) pivots to be bent. This configuration allows adjacent pairs of links 518 of the axial support structure 512 to bend in different directions (e.g., along a bending axis B that is transverse to the longitudinal neutral axis). It should be understood that although the links 518 are shown with the hinges 520 oriented distally within the axial support structure 512, the links 518 can also have the opposite orientation, with the hinges 520 oriented proximally.

[0133] The articulation angle α of adjacent links 518 can be the combined angle of adjacent end faces 524 (e.g., end faces 524 extending away from hinge 520 and end faces 524 extending away from socket 522) of adjacent links 518 relative to a horizontal plane extending orthogonal to the longitudinal axis of the link 518. In other words, the end faces 524, as they extend laterally away from the hinge 520 and / or socket 522, can reduce the axial length of the link 518. This reduced axial length provides clearance for adjacent links 518 to pivot relative to each other about the hinge / socket interface. In the example of Figure 5B and Figure 5C In one example shown, the end face 524 of the first end 518a of the body is angled laterally away from the hinge 520 relative to a horizontal plane and downwardly therefrom, and the end face 524 of the second end 518b of the body is flat and extends generally along the horizontal plane. It should be understood that "angled laterally away" can include a continuous end face as shown, and can also include discrete / discrete portions of the end face that are configured to receive adjacent end faces against them when the links 518 are fully pivoted relative to each other. In other examples, both end faces 524 can be angled (e.g., the same or different angles), or the end face 524 of the first end 518a can be flat, while the end face 524 of the second end 518b can be angled laterally away from the socket 522 relative to a horizontal plane and downwardly therefrom. Additionally, while the end faces 524 are shown as extending continuously between the hinges 520 or sockets 522 (except for the optional pull wire relief feature described below), other embodiments can include additional recesses or cavities such that the end faces 524 of adjacent links 518 contact each other only at discrete locations.

[0134] In some examples, the articulation of the articulated main body portion 510 can be controlled by a plurality of pull wires 526 extending longitudinally along the flexible body 502. Thus, each link 518 can receive the pull wire 526 passing therethrough. For example, each link 518 can define a plurality of pull wire openings 528 extending longitudinally through the main body, one pull wire opening 528 for each pull wire 526, and the pull wire opening 528 corresponds to the number and circumferential orientation of the pull wire 526. The pull wire opening 528 can take any suitable form. For example, the pull wire opening 528 can have a circular cross section as shown in the figure, or it can be elliptical or rectangular. In some examples, the pull wire opening 528 can be sized to closely match the size of the pull wire 526. In some examples, the pull wire opening 528 can be sized to have a gap around one or more sides of the pull wire 526.

[0135] The flexible elongated device 500 can include any number of pull wires 526 to provide the desired amount of articulation. In some embodiments, the flexible elongated device 500 can include 2, 3, 4, 5, 6 or more pull wires 526 to articulate the articulated main body portion 510. Three or four pull wires 526 can provide articulation along the pitch and yaw axes. In addition to providing additional functions or complex geometric shapes (e.g., S curvature), more than four pull wires 526 also provide articulation along the pitch and yaw axes. The circumferential offset angle of the hinge 520 and the socket 522 of each link 518 can be configured to accommodate (accommodate) the desired articulation bend and / or style.

[0136] As shown, for the four-pulling wire 526 configuration, the hinge 520 and the socket 522 can be circumferentially offset 90 degrees relative to each other, so that every other pair of adjacent links 518 of the axial support structure 512 can be bent along the same axis, and the axial support structure 512 can be bent along two axes (e.g., pitch and yaw). In other examples, the hinge 520 and the socket 522 can be circumferentially offset 120 degrees relative to each other to achieve a three-pulling wire 526 configuration; 72 degrees relative to each other circumferentially offset to achieve a five-pulling wire 526 configuration; 60 degrees relative to each other circumferentially offset to achieve a six-pulling wire 526 configuration; and so on. Other suitable configurations of additional pulling wires 526 can also be adopted.

[0137] To avoid or minimize (e.g., plastic) deformation of the pull wire 526, each of the links 518 can include a relief feature to accommodate the pull wire 526 during articulation of the articulatable body portion 510. The relief features can be different depending on the position of the ends of the pull wire openings 528 relative to the bending axis B of an adjacent pair of links 518. Figure 5B-5EIn the illustrated example of four pull wires 526, each link 518 can include one or more recesses 530 defined on the end surface 524 of the link 518 and aligned with the open end of the pull wire transverse to the adjacent hinge 520 or socket 522 (e.g., transverse to the bending axis B). In the illustrated form with four pull wires 526, each link includes two recesses 530 at each end. Figure 5E As shown, when an adjacent pair of links 518 are bent along the bending axis B, the aligned recesses 530 of the adjacent pair of links 518 provide a cavity through which the pull wire 526 can extend. If the link 518 does not include the recess 530, the pull wire 526 will experience more extreme angles during (e.g., full) bending. In another example, as Figure 5B-5D and Fig. 5F As shown, the pull wire opening 528 of each link 518 can have an elongated configuration at one end thereof parallel to the hinge 520 or the socket 522 (e.g., parallel to the bending axis B). In the illustrated embodiment, the elongated configuration is located at the end of the pull wire opening 528 opposite the recess 530, so that the pull wire 526 has a clearance at both ends of the link 518. In one example, when the opening 528 extends to an end that is aligned approximately parallel to the bending axis B of the adjacent hinge and socket interface, the elongated configuration is provided by the inner surface 532 of the pull wire opening 528, and the inner surface 532 has at least one expanded internal dimension (e.g., as shown in the figure, along a straight line or arcuate, such as by length and / or width, expanding to a progressively elongated slot opening). It should be understood that the terms "transverse" and "parallel", when used to describe positioning relative to the hinge and socket interface, can include a range of angles relative to the bending axis B. For example, the extended interior dimension relief feature can be located on one side of the respective hinge 520 / socket 522 and still be considered aligned parallel to the bending axis B relative to the recess 530, which is spaced a greater distance from the respective hinge 520 / socket 522 than the extended interior dimension relief feature. In alternative embodiments, the angular position of the hinge 520 / socket 522 relative to the pull wire opening 528 can be greater or lesser. For example, the pull wire opening 528 can be directly aligned with the hinge 520 / socket 522 interface or can be at up to 45 degrees from the hinge 520 / socket 522 interface.

[0138] In some examples, the links 518 are not interlocked. Thus, when tension is applied to the axial support structure 512, the links 518 will easily disengage. To keep the links 518 engaged with each other, the flexible elongated device 500 can include a braided sheath, such as the braided sheath 418 described above, having ends coupled (e.g., welded) to the distal member 514 and the proximal member 516.

[0139] like Figure 5AAs shown, the flexible elongated device 500 can include an inner body member 534 extending through the axial support structure 512. In this example, the link 518 defines a central hole 536, the central hole 536 is sized to receive the inner body member 534 therethrough, and the hinge 520 and the socket 522 include portions aligned across the central hole 536. For example, the link 518 can have an annular shape. Other examples, such as examples without a central hole, can be applicable to other steerable tools (e.g., cardiac mapping catheters) or non-medical steerable tools (e.g., endoscopes or plumber's scopes).

[0140] In some examples, the hinge 520 can include an inwardly tapered surface (e.g., tapered toward the first end 518a of the body of the link 518) that is configured to receive the socket 522 of the adjacent link 518 thereon. As shown, the outward radial end of the hinge 520 provides the highest axial height for the hinge 520, and as its surface extends radially inward, the surface tapers downward relative to the radial end. As the socket 522 of the adjacent link 518 slides relative to the hinge 520, the inwardly tapered surface is configured to center the adjacent link 518 when the socket 522 is disposed on the hinge 520. In the form that includes a central hole 536, the portions aligned across the central hole 536 can each have an inwardly tapered surface, such as having a frustoconical or spherical configuration, and the socket 522 can have a complementary conical / spherical shape.

[0141] In some examples, the inner body member 534 can define or include a lumen 538 extending through the flexible body 502. The lumen 538 can provide a delivery channel for a medical tool to be inserted through the flexible body 502, such as an endoscope, a biopsy needle, an endobronchial ultrasound (EBUS) probe, an imaging probe, an ablation tool, an electroporation tool, a chemical delivery tool, a smaller flexible elongated device, and / or the like.

[0142] like Figure 5A and Figure 5GAs shown, the flexible elongated device 500 can include one or more component wires 540 extending along its length. The component wires 540 can include various components of the flexible elongated device 500 (e.g., shape sensors) or parts of components located more distally (e.g., wiring for sensors or other electronic devices, optical fibers for illumination of imaging devices, fluid tubing, etc.). In examples with multiple component wires 540, the wires 540 can extend along the flexible elongated device 500 individually or bundled together. The component wires 540 can have any desired function. In some examples, the flexible elongated device 500 can include one or more of the following: a shape sensor (e.g., a fiber optic shape sensor) or (one or more) other orientation / posture sensors, imaging devices, wires, optical fibers for illumination, etc. In the example shown, the flexible elongated device 500 includes a camera 540a and a shape sensor 540b.

[0143] The links 518 can advantageously define one or more component openings 542 extending longitudinally through the body to allow the component line 540 to extend through the articulated body portion 410. In some examples, it can be helpful that at least a plurality of the links 518 are identical for manufacturing purposes, however, due to the rotation necessary for the hinge to socket offset, the dedicated component openings will not align all the way through the axial support structure 512. Therefore, the links 518 can include a plurality of component openings 542 spaced from one another such that when adjacent links are rotated due to the offset of the hinge to socket interface, one of the component openings 542 is always aligned along the component line path. In a further example, each link can include three component openings 542 spaced from one another such that two component openings of adjacent links 518 are always aligned to provide a longitudinal component line path through the axial support structure 512.

[0144] In some examples, component openings 542 can have different configurations for different component lines 540. Figure 5B and Figure 5CAs shown, each link 518 can include two elongated component openings 542a and one size-constrained component opening 542b. With this configuration, one of the component line paths is defined by the elongated openings 542a through the axial support structure 512 for components that need or can operate within the elongated space, while the other component line path is defined by the size-constrained component openings 542b in every other link 518. For example, a shape sensor 520b (or other position sensor) can be routed through the component line path of alternating links having size-constrained component openings 542b to keep the position sensor 520a through the axial support structure 512 and fixed in position relative to the axial support structure 512. Advantageously, constraining the shape sensor 520 in every other link 518 is sufficient to ensure accurate shape / position sensing while also allowing all or multiple links 518 in the axial support structure 512 to have the same structure. Components that are not positionally sensitive relative to the axial support structure 512, such as wiring for the camera 540a or lighting, can be routed through the pathway defined by the elongated member openings.

[0145] The component opening 542 can have any suitable cross-sectional shape, including circular, oval, track-shaped, rectangular, square, etc. The component opening 542 and other edges of the link 518 can be chamfered. As shown, the component opening 542 can open into the central hole 536, open through the outer surface of the link 518, or have no opening through the inner / outer surface. In some examples, the component opening 542 can be configured to allow (one or more) component wires 540 to spiral around the circumference of the axial support structure 512.

[0146] The distal member 514 of the flexible elongated device 500 is shown in Figure 5H . The distal member 514 includes a tip 544 and a control structure 546 (e.g., a control ring). In this example, the tip 544 and the control structure 546 are a single piece component (e.g., formed or non-releasably fixed together by welding or the like). In order to control the articulation of the articulated body portion 510 using the pull wires 526, at least two of the pull wires 526 are attached (e.g., welded, attached, etc.) to the control structure 546 of the distal member 514, and in some embodiments, all of the pull wires 526 are attached to the control structure 546. The pull wires 526 can be coupled to the outer surface of the control structure 546 and / or the control structure 546 can define a channel or recess 548 to receive the distal end of the pull wire 526 therein. Further, the control structure 546 can also include a socket 522, which is configured to receive the hinge 520 of the distal link 518 of the axial support structure 512 therein.

[0147] As shown, the distal member 514 can define a central hole 550 that is aligned with the central hole 536 of the axial support structure 512. The central hole 550 can receive the inner body member 534 or its extended sheath 552 therein to provide a continuous passage through the distal end of the flexible elongated device 500. The distal member 514 can also define an opening 554 for the component 540, which is aligned with the passage through the axial support structure 512 to expose the distal end of the component 540 at the distal end of the flexible elongated device 500.

[0148] Figure 6 A distal member 614 suitable for flexible elongated device 500 is shown, replacing its distal member 514. In this form, the distal member 614 includes a tip 644 and a separate control structure 646 (e.g., a control ring) configured to be coupled to the tip 644. For example, the control structure 646 can be snap-fitted to the tip 644, threaded coupling, etc. In order to control the articulation of the articulated body portion (e.g., the articulated body portion 510), in this form all the pull wires 626 are attached (e.g., welded, attached, etc.) to the control structure 646 of the distal member 614. The pull wire 626 can be coupled to the outer surface of the control structure 646 and / or the control structure 646 can define a channel or recess 648 to receive the distal end of the pull wire 626 therein. Further, control structure 646 can also include a socket 622 configured to receive a hinge of a distal link of an axial support structure (eg, hinge 520 , link 518 , axial support structure 512 ) therein.

[0149] As shown, the distal member 614 can define a central hole 650 aligned with a hole or cavity of the flexible elongated device (e.g., the central hole 536 of the axial support structure 512). The central hole 650 can receive an inner body member (e.g., the inner body member 534) or an extension sheath therein to provide a continuous passage through the distal end of the flexible elongated device. The distal member 614 can also define an opening 654 for a component (e.g., component 540) of the flexible elongated device, the opening 654 being aligned with the component path through the axial support structure so that the distal end of the component is exposed at the distal end of the flexible elongated device.

[0150] Figure 7 A distal member 714 suitable for use with the flexible elongated device 500 is shown in place of the distal member 514 thereof. The distal member 714 includes a tip 744 and a control structure 746 (e.g., a control ring). The tip 744 and the control structure 746 can be, for example, Figure 6 The individual components shown in the form of being configured to be coupled together can also be configured as Figure 5H Single-piece components shown in the form.

[0151] In this example, a portion of the pull wire 726 is attached to the control structure 746, and a portion of the pull wire 726 is attached to the distal link 718, which is adapted to the axial support structure 512 and has the structure described above with respect to the link 518. In the example of four pull wires 726 shown, two opposing pull wires 726 are attached to the control structure 746 to control articulation (e.g., pitch or yaw) about a first axis, and two opposing pull wires 726 are attached to the distal link 718 to control articulation (e.g., pitch or yaw) about a second axis. The pull wires 726 can be coupled to the outer surface of the control structure 746 / distal link 718 and / or the control structure 746 / distal link 718 can define a channel or recess 748 to receive the distal end of the pull wire 726 therein. Further, the control structure 746 can also include a socket 722 configured to receive the hinge 720 of the distal link 718 therein.

[0152] As shown, the distal member 714 can define a central hole 750 aligned with a hole or cavity of the flexible elongated device (e.g., the central hole 536 of the axial support structure 512). The central hole 750 can receive an inner body member (e.g., the inner body member 534) or an extension sheath therein to provide a continuous passage through the distal end of the flexible elongated device. The distal member 714 can also define an opening 754 for a component (e.g., component 540) of the flexible elongated device, the opening 754 being aligned with the component path through the axial support structure so that the distal end of the component is exposed at the distal end of the flexible elongated device.

[0153] The articulation angle α of adjacent links 718 and / or distal links 718 to the control structure 746 can be the combined angle of adjacent end surfaces 724, 725 of the adjacent components (e.g., end surface 724 extending away from hinge 720 and end surface 725 extending away from socket 722) relative to a horizontal plane extending orthogonal to the longitudinal axis of the link 718 / control structure 746. In other words, the end surfaces 724, 725, as they extend laterally away from the hinge 720 and / or socket 722, can reduce the axial length of the link 718 / control structure 746. This reduced axial length provides clearance for adjacent links 718 to pivot relative to each other about the hinge / socket interface. In one example, Figure 7As shown, the end face 724 of the link 718 is laterally away from the hinge 720 relative to the horizontal plane and angled downward therefrom, while the end face 725 of the control structure 746 is laterally away from the socket 722 relative to the horizontal plane and angled upward therefrom. Although the control structure 746 is shown with the end face 725 angled laterally away from the socket 722, any or all of the links 718 in the axial support structure can include similarly configured end faces 724. It should be understood that "angled laterally away" can include a continuous end face as shown in the figure, and can also include discrete / discrete portions of the end face that are configured to receive adjacent end faces against them when the links 718 are fully pivoted relative to each other. Additionally, while the end faces 724 are shown as extending continuously between the hinges 720 or sockets 722 (except for the optional pull wire relief feature described below), other embodiments can include additional recesses or cavities such that the end faces 724 of adjacent links 718 contact each other only at discrete locations.

[0154] In any of the above examples, one or more components of the flexible elongated device 400, 500 can include a friction-reducing coating, layer or component. For example, the link 518 can have any of the following materials disposed thereon: a polyparaxylene coating, a lubricant (e.g., oil) coating, a powder (e.g., molybdenum disulfide) coating, a polytetrafluoroethylene (PTFE) coating, a chrome plating, a diamond-like carbon (DLC) coating, a titanium nitride (TiN) coating, and / or a zirconium nitride coating. These materials can reduce friction between the hinge 522 and the socket 522 of the axial support structure 512 and between the link 518 and a braided sheath (e.g., braided sheath 418) disposed around the link 518. In some examples, the pull wire opening 528 can include a low friction sleeve or coating (e.g., any of the above materials) to reduce friction on the pull wire 526 when the pull wire 526 moves relative to the link 518 during articulation.

[0155] As described above, the combined angle of adjacent end faces 524 of adjacent links 518 is the articulation angle α of the link 518. In some examples, the axial support structure 512 can have the same articulation angle for all links 518. In other examples, the axial support structure 512 can include multiple articulation angles, such as two, three, four, or more. Accordingly, the maximum articulation angle of the axial support structure 512 can be provided by the distal link in the link 518 and / or the axial support structure 512 can include multiple articulation angles that increase distally.

[0156] In some examples, the links 518 can be made of a metal such as stainless steel, titanium, or tungsten. In other examples, the links 518 can be made of a polymer. In other examples, the links 518 can be made of one or more materials that do not include Nitinol.

[0157] In some examples, all of the links 518 in the axial support structure 512 are identical. In other examples, the distal links 518 of the axial support structure 512 have a shortened longitudinal length relative to the other links 518 in the axial support structure 512. In these examples, the links 518 other than the distal links 518 can be identical. In other or additional examples, the hinge 520 / socket 522 interface and the end face 524 can be configured to provide different overall bend angles in different bend planes.

[0158] In some examples, one or more of the links 518 can have a ground outer surface. For example, the links 518 can be formed by metal injection molding and undergo a grinding process. The stacked links 518 can be placed on a mandrel and ground to remove wall thickness until the links 518 have a desired outer diameter. The grinding process can include centerless grinding. In these examples, the surface of the center hole 536 of the link 518 (if included) can remain in a rough, unground state.

[0159] In any examples provided herein, the diameter of the center hole 536 of the link can be between about 2.45 mm and about 2.8 mm; the outer diameter of the link 518 can be between about 3.81 mm and about 3.66 mm; the thinnest wall section of the link 518 can be between about 0.15 mm and about 0.23 mm; and / or the thickest wall section of the link 518 can be between about 0.43 mm and about 0.61 mm.

[0160] In any examples provided herein, the axial support structure 512 can include up to 25 links 518 or more to provide at least 185 degrees of bend plane articulation and at least 262 degrees of 45 degree deviation from the bend plane articulation; and / or the axial support structure 512 can allow a 12 mm bend radius or greater (e.g., a bend plane radius of at least 13.7 mm and a 45 degree deviation from the bend plane radius of at least 9.7 mm).

[0161] In any examples provided herein, the height of the hinge 522 to the socket 520 can be between about 0.35 mm and about 0.38 mm; and / or the inwardly tapered surface of the hinge 520 can taper at an angle between about 11.5 degrees and about 12.5 degrees.

[0162] One or more components of the embodiments discussed in the present disclosure (such as the control system 112) can be implemented with software executed on one or more processors of a computer system. The software may include code that, when executed by one or more processors, configures the one or more processors to perform various functions discussed herein. The code may be stored in a non-transitory computer-readable storage medium (e.g., a memory, a magnetic storage, an optical storage, a solid-state storage, etc.). The computer-readable storage medium may be part of a computer-readable storage device, such as an electronic circuit, a semiconductor device, a semiconductor memory device, a read-only memory (ROM), a flash memory, an erasable programmable read-only memory (EPROM), a floppy 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 a plurality of separate programs or subroutines, which may also be integrated into a plurality of other aspects of the system described herein. The components of the computing system discussed herein may be connected using wired and / or wireless connections. In some examples, the wireless connection can use wireless communication protocols such as Bluetooth, near field communication (NFC), infrared data communication (IrDA), home radio frequency (HomeRF), IEEE 802.11, digital enhanced wireless communication (DECT), and wireless medical telemetry service (WMTS).

[0163] Various general-purpose computer systems may be used to perform one or more processes, methods, or functions described herein. Additionally or alternatively, various special-purpose computer systems may be used to perform one or more processes, methods, or functions described herein. In addition, various programming languages ​​may be used to implement one or more processes, methods, or functions described herein.

[0164] Although certain embodiments and examples have been 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, since those skilled in the art will recognize various other alternatives, modifications, and equivalents.

Claims

1. A flexible elongated device comprising: an elongated body having an articulatable body portion; and an axial support structure within the articulatable body portion, the axial support structure comprising a plurality of links stacked longitudinally upon one another, each of the plurality of links comprising: a body having a first end and a second end, the body defining a plurality of pull wire openings extending therethrough to receive a plurality of pull wires for controlling articulation of the articulatable body portion; a hinge projecting outwardly from said first end of said body; a socket at the second end of the body, the socket being circumferentially offset relative to the hinge and configured to receive the hinge of one of the links therein; a first pull wire relief recess at the first end of the body aligned with a first pull wire opening transverse to the hinge; and A second pull wire relief recess at the second end of the body is aligned with a second pull wire opening transverse to the socket.

2. A flexible, elongated device according to claim 1, wherein the first pull-wire opening at the second end of the body has an elongated configuration parallel to the socket; and the second pull-wire opening at the first end of the body has an elongated configuration parallel to the hinge.

3. A flexible, elongated device according to claim 1 or 2, wherein the hinge comprises an inwardly tapered surface configured to center adjacent links of the plurality of links when the sockets of the adjacent links are disposed on the hinge.

4. A flexible, elongated device according to any one of the preceding claims, wherein the first end of the body has an end surface angled away from the hinge, the second end of the body has an end surface angled away from the socket, or both.

5. A flexible, elongated device according to any one of the preceding claims, wherein the body of each of the plurality of links defines three component openings extending therethrough, adjacent links of the plurality of links having two component openings, the two component openings being aligned to provide a longitudinal path through the axial support structure.

6. The flexible, elongated device of claim 5, wherein the three component openings include two elongated component slots and a cylindrical opening, the cylindrical openings of the plurality of links providing a restricted longitudinal path through the axial support structure.

7. The flexible elongated device according to claim 6, further comprising: a first component line including a shape sensor received within a constrained longitudinal path through the axial support structure; and A component line is received within another longitudinal path.

8. A flexible, elongated device according to any one of the preceding claims, wherein the hinge and the socket are offset relative to each other at an angle corresponding to the multiple pull wires to allow the hingeable body portion to be hinged along the axis of each of the multiple pull wires.

9. A flexible, elongated device according to claim 8, wherein the hinge and the socket are offset 90 degrees relative to each other; so that the plurality of pull wires control the articulation of the articulated body portion along the pitch axis and the yaw axis.

10. The flexible, elongated device of claim 8, wherein the hinge and the socket are offset 120 degrees relative to each other.

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